10q10k10q10k.net

What changed in Rallybio Corp's 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Rallybio Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+604 added−750 removedSource: 10-K (2026-03-16) vs 10-K (2025-03-13)

Top changes in Rallybio Corp's 2025 10-K

604 paragraphs added · 750 removed · 371 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

100 edited+63 added−242 removed254 unchanged
Biggest changeAPS disease background APS is a potentially life-threatening, rare autoimmune disorder in which an individual's immune system mistakenly creates antiphospholipid antibodies that can lead to the formation of blood clots. Blood clots can occur in the legs, lungs, brain, and other organs, such as the kidneys and spleen. The clots can lead to a heart attack or a stroke.
Biggest changeAnd third – and most importantly – we believe that RLYB116 could potentially provide transformative therapeutic impact for unserved and underserved patients with PTR globally. APS disease background APS is a potentially life-threatening, rare autoimmune disorder in which an individual's immune system mistakenly creates antiphospholipid antibodies that can lead to the formation of blood clots.
The International Recognition Procedure provides the framework for the MHRA to take into account assessments of medicinal products conducted by trusted regulatory authorities in Australia, Canada, Switzerland, Singapore, Japan, the United States and the EU when assessing applications for marketing authorization.
The International Recognition Procedure ("IRP") provides the framework for the MHRA to take into account assessments of medicinal products conducted by trusted regulatory authorities in Australia, Canada, Switzerland, Singapore, Japan, the United States and the EU when assessing applications for marketing authorization.
These laws, some of which will apply only if and when we have an approved product, include: • federal false claims, false statements and civil monetary penalties laws prohibiting, among other things, any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made, a false statement to get a false claim paid; • federal healthcare program anti-kickback law, which prohibits, among other things, persons from offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for, or the purchasing or ordering of, a good or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid; • the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products prior to approval or for off-label use and regulates the distribution of samples; • federal laws that require pharmaceutical manufacturers to calculate, report and certify certain complex product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; • federal Open Payments (or federal “sunshine” law), which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with certain healthcare providers to the Centers for Medicare & Medicaid Services within the U.S.
These laws, some of which will apply only if and when we have an approved product, include: • federal false claims, false statements and civil monetary penalties laws prohibiting, among other things, any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made, a false statement to get a false claim paid; • federal healthcare program anti-kickback law, which prohibits, among other things, persons from offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for, or the purchasing or ordering of, a good or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid; • the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; 26 T a b le of Contents • FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products prior to approval or for off-label use and regulates the distribution of samples; • federal laws that require pharmaceutical manufacturers to calculate, report and certify certain complex product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; • federal Open Payments (or federal “sunshine” law), which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with certain healthcare providers to the Centers for Medicare & Medicaid Services within the U.S.
Biosimilars and Reference Product Exclusivity for Biological Products In March 2010, the Patient Protection and Affordable Care Act was enacted in the United States and included the Biologics Price Competition and Innovation Act of 2009 (the "BPCIA").
Biosimilars and Reference Product Exclusivity for Biological Products In March 2010, the Patient Protection and Affordable Care Act ("ACA") was enacted in the United States and included the Biologics Price Competition and Innovation Act of 2009 (the "BPCIA").
RLYB116 includes an Affibody molecule, which is an antibody mimetic protein that has a much smaller molecular weight than a traditional antibody and may also be easier and less costly to produce.
RLYB116 includes an Affibody molecule, which is an antibody mimetic protein that has a much smaller molecular weight than a traditional antibody and may be easier and less costly to produce.
Department of Health and Human Services ("CMS") for re-disclosure to the public, as well as ownership and investment interests held by physicians and their immediate family members; • federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; • analogous state laws and regulations, including: state anti-kickback and false claims laws; state laws requiring pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or report information related to payments to health care providers, marketing expenditures or drug prices; state laws regulating the manufacture and distribution of biopharmaceutical products; and state laws governing privacy, security and breaches of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and • laws and regulations prohibiting bribery and corruption, such as the U.S.
Department of Health and Human Services ("CMS") for re-disclosure to the public, as well as ownership and investment interests held by physicians and their immediate family members; • federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; • analogous state laws and regulations, including: state anti-kickback and false claims laws; state laws requiring pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or report information related to payments to health care providers, marketing expenditures or drug prices; state or local laws requiring the registration of pharmaceutical sales representatives; state laws regulating the manufacture and distribution of biopharmaceutical products; and state laws governing privacy, security and breaches of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and • laws and regulations prohibiting bribery and corruption, such as the U.S.
Such conditional approvals may be granted for product candidates (including medicines designated as orphan medicinal products) if (1) the product candidate is intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases; (2) the drug candidate is intended to meet unmet medical 34 Table of Contents needs of patients; (3) a MA may be granted prior to submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required; (4) the risk-benefit balance of the product candidate is positive, and (5) it is likely that the applicant will be in a position to provide the required comprehensive clinical trial data.
Such conditional approvals may be granted for product candidates (including medicines designated as orphan medicinal products) if (1) the product candidate is intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases; (2) the drug candidate is intended to meet unmet medical needs of patients; (3) a MA may be granted prior to submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required; (4) the risk-benefit balance of the product candidate is positive, and (5) it is likely that the applicant will be in a position to provide the required comprehensive clinical trial data.
We also filed and own eight pending provisional patent applications directed to methods of treatment of various C5-related conditions by administration of RLYB116. We have also non-exclusively in-licensed certain patent rights relating to our current product candidates from Affibody, including patent rights relating to the Affibody molecule technology and Albumod albumin binding molecule technology.
We also filed and own nine pending provisional patent applications directed to methods of treatment of various C5-related conditions by administration of RLYB116. We have also non-exclusively in-licensed certain patent rights relating to our current product candidates from Affibody, including patent rights relating to the Affibody molecule technology and Albumod albumin binding molecule technology.
We currently employ internal resources to manage our CMOs. We believe that RLYB212, RLYB116, REV102 and RLYB332 can be manufactured through reliable and reproducible biologic and chemical processes from readily available starting materials. We believe that our manufacturing processes are amenable to scale-up and will not require unusual or expensive equipment.
We currently employ internal resources to manage our CMOs. We believe that RLYB116 and RLYB332 can be manufactured through reliable and reproducible biologic and chemical processes from readily available starting materials. We believe that our manufacturing processes are amenable to scale-up and will not require unusual or expensive equipment.
Patent Term Restoration and Hatch-Waxman Marketing Exclusivity Depending upon the timing, duration and specifics of FDA approval for our product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.
Patent Term Restoration and Hatch-Waxman Marketing Exclusivity Depending upon the timing, duration and specifics of FDA approval for our product candidates, some of our U.S. patents may be eligible for limited PTE under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.
As of March 1, 2025, we exclusively in-licensed from Kymab Limited certain patent rights to the current product candidate in our iron overload program, RLYB332, as well as back-up compounds. Under the exclusive license, we are managing prosecution of a patent family relating to RLYB332 and the back-up compounds.
As of March 1, 2026, we exclusively in-licensed from Kymab Limited certain patent rights to the current product candidate in our iron overload program, RLYB332, as well as back-up compounds. Under the exclusive license, we are managing prosecution of a patent family relating to RLYB332 and the back-up compounds.
If the Sanofi License Agreement is terminated in its entirety, among other things (a) all rights and licenses granted by Sanofi under the License Agreement (including any sublicenses) will terminate and (b) if Sanofi has an interest in developing, manufacturing and commercializing the licensed compounds or products, the parties to the Sanofi License Agreement shall negotiate an arrangement to provide Sanofi rights to the patents, know-how, materials and other properties controlled by Rallybio applicable to any of the licensed product. 20 Table of Contents Asset Purchase Agreements Asset Transfer Agreement with Swedish Orphan Biovitrum AB (Publ) In March 2019, through IPC Research, we entered into an agreement with Sobi, pursuant to which we acquired the right, title and interest in assets related to certain C5 inhibitor compounds.
If the Sanofi License Agreement is terminated in its entirety, among other things (a) all rights and licenses granted by Sanofi under the License Agreement (including any sublicenses) will terminate and (b) if Sanofi has an interest in developing, manufacturing and commercializing the licensed compounds or products, the parties to the Sanofi License Agreement shall negotiate an arrangement to provide Sanofi rights to the patents, know-how, materials and other properties controlled by Rallybio applicable to any of the licensed product. 10 T a b le of Contents Asset Purchase Agreements Asset Transfer Agreement with Swedish Orphan Biovitrum AB (Publ) In March 2019, through IPC Research, we entered into an agreement with Sobi, pursuant to which we acquired the right, title and interest in assets related to certain C5 inhibitor compounds.
For the FDA to approve a biosimilar product 30 Table of Contents as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product and (for products administered multiple times) that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product and (for products administered multiple times) that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
Only one patent applicable to an approved drug is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
Only one patent applicable to an approved drug is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any PTE or restoration.
In each case, there can exist no satisfactory method of diagnosis, prevention or treatment of such condition authorized in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition.
In each case, there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized in the EU, or if such a method exists, the product will be of significant benefit to those affected by the condition.
Other potential consequences include, among other things: • restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; • safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about a product; • mandated modification of promotional materials and labeling and issuance of corrective information; • fines, warning letters, untitled letters or other enforcement-related letters or clinical holds on post-approval clinical trials; • refusal of the FDA to approve pending NDAs/BLAs or supplements to approved NDAs/BLAs, or suspension or revocation of product approvals; 29 Table of Contents • product seizure or detention, or refusal to permit the import or export of products; • injunctions or the imposition of civil or criminal penalties; and • consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective information.
Other potential consequences include, among other things: • restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; • safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about a product; • mandated modification of promotional materials and labeling and issuance of corrective information; • fines, warning letters, untitled letters or other enforcement-related letters or clinical holds on post-approval clinical trials; 18 T a b le of Contents • refusal of the FDA to approve pending NDAs/BLAs or supplements to approved NDAs/BLAs, or suspension or revocation of product approvals; • product seizure or detention, or refusal to permit the import or export of products; • injunctions or the imposition of civil or criminal penalties; and • consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective information.
Where the medical device component has not already been CE marked, the MA application dossier must include an opinion issued by a notified body on the conformity of the device 33 Table of Contents component against the relevant general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745.
Where the medical device component has not already been CE marked, the MA application dossier must include an opinion issued by a notified body on the conformity of the device component against the relevant general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745.
Health care reform, specifically reform addressing pricing and payment for drugs, has been an ongoing focus and is likely to continue under the Trump Administration. A number of healthcare reforms involving drugs have been successfully implemented, including reforms related to Medicare payment for drugs and manufacturer rebate obligations under the Medicaid Drug Rebate Program.
Health care reform, specifically reform addressing pricing and payment for drugs, has been an ongoing focus and is likely to continue under the current presidential administration. A number of healthcare reforms involving drugs have been successfully implemented, including reforms related to Medicare payment for drugs and manufacturer rebate obligations under the Medicaid Drug Rebate Program.
There have been several developments in recent years with respect to U.S. state data privacy laws. For example, the California Consumer Privacy Act of 2018, as amended and supplemented by the California Privacy Rights Act (collectively, “CCPA”) imposed many requirements for the collection, processing, and sharing of personal information of California residents.
There have been several developments in recent years with respect to U.S. state data privacy laws. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act (collectively, “CCPA”) imposes many requirements for the collection, processing, and sharing of personal information of California residents.
Artificial Intelligence Drug Discovery Collaboration In July 2019, we formed a joint venture with Exscientia Limited ("Exscientia"), an Oxford, UK-based artificial intelligence ("AI") and machine learning drug discovery company with a proprietary chemical design platform to discover novel small molecule drug candidates. Exscientia was acquired by Recursion Pharmaceuticals, Inc.
Artificial Intelligence Drug Discovery Collaboration In July 2019, we formed a joint venture with Exscientia Limited ("Exscientia"), an Oxford, UK-based artificial intelligence ("AI") and machine learning drug discovery company with a proprietary chemical design platform to discover novel small molecule drug candidates. Exscientia was acquired by Recursion in 2024.
APS can occur on its own but can also occur secondary to other autoimmune diseases such as systemic lupus erythematosus. 11 Table of Contents APS affects three to five times as many women as men and is most often diagnosed in people between the ages of 30 and 50.
APS can occur on its own but can also occur secondary to other autoimmune diseases such as systemic lupus erythematosus. APS affects three to five times as many women as men and is most often diagnosed in people between the ages of 30 and 50.
Of our full-time employees, 14 employees are engaged in new product sourcing through business development, research, manufacturing, product development and clinical development, and 11 are engaged in executive, finance, human resources, legal and other administrative functions. None of our employees are represented by a labor union or covered by a collective bargaining agreement.
Of our full-time employees, 7 employees are engaged in new product sourcing through business development, research, manufacturing, product development and clinical development, and 7 are engaged in executive, finance, human resources, legal and other administrative functions. None of our employees are represented by a labor union or covered by a collective bargaining agreement.
This multi-year, multi-target collaboration will combine AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates and ultimately deliver therapies to patients. Under the terms of the agreement, AbCellera and Rallybio will co-develop up to five rare disease therapeutic targets, which will be chosen together by both companies.
This multi-year, multi-target collaboration combined AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates and ultimately deliver therapies to patients. Under the terms of the agreement, AbCellera and Rallybio were planning to co-develop up to five rare disease therapeutic targets, which will be chosen together by both companies.
An equivalent regime is reflected in domestic law in the UK. Under the UK regime, however, orphan designations are not granted and instead a decision is made at the point of marketing authorization grant. RLYB212 has been granted orphan drug designation by the EMA for the prevention of FNAIT.
An equivalent regime is reflected in domestic law in the UK. Under the UK regime, however, orphan designations are not granted and instead a decision is made at the point of MA grant. RLYB212 has been granted orphan drug designation by the EMA for the prevention of FNAIT.
If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS and the FDA will not approve the NDA or BLA without a REMS. 26 Table of Contents Under the Pediatric Research Equity Act of 2003 ("PREA"), an NDA or BLA or certain supplements thereto must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless this requirement is waived, deferred or inapplicable.
If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS and the FDA will not approve the NDA or BLA without a REMS. 15 T a b le of Contents Under the Pediatric Research Equity Act of 2003 ("PREA"), an NDA or BLA or certain supplements thereto must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless this requirement is waived, deferred or inapplicable.
This multi-year, multi-target collaboration will combine AbCellera Biologic's 4 Table of Contents ("AbCellera") antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates with a goal of delivering therapies to patients.
This multi-year, multi-target collaboration will combine AbCellera Biologic's ("AbCellera") antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates with a goal of delivering therapies to patients.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol, GCP or other IRB requirements or if the drug has been associated with unexpected serious harm to patients. 25 Table of Contents During the development of a new drug or biological product, sponsors have the opportunity to meet with the FDA at certain points, including prior to submission of an IND, at the end of phase 2 and before submission of an NDA or BLA.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the clinical protocol, GCP or other IRB requirements or if the drug has been associated with unexpected serious harm to patients. 14 T a b le of Contents During the development of a new drug or biological product, sponsors have the opportunity to meet with the FDA at certain points, including prior to submission of an IND, at the end of phase 2 and before submission of an NDA or BLA.
Once renewed, the MA is generally valid for an unlimited period, unless the European Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
Once renewed, the MA is generally valid for an unlimited period, unless the EC or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the MA holder obtains 22 T a b le of Contents an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
Under the BPCIA, a manufacturer may submit an application that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity and potency.
Under the BPCIA, a manufacturer may submit an application that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar 19 T a b le of Contents product, it must find that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity and potency.
Many of our competitors may have significantly greater name recognition and financial, manufacturing, marketing, product development, technical, commercial infrastructure, and human resources than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors.
Many of our competitors may have significantly greater name recognition and financial, manufacturing, marketing, product development, technical, commercial infrastructure, and human resources than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even 7 T a b le of Contents more resources being concentrated among a smaller number of our competitors.
Based on the data generated to date and the manufacturing process enhancements completed in 2024, we believe RLYB116 has the potential to demonstrate these attributes, and if so, could have a life-transforming impact on patients.
Based on the data generated to date and the manufacturing process enhancements completed in 2024, we believe RLYB116 has the potential to demonstrate these attributes as a best-in-class therapeutic, and if so, could have a life-transforming impact on patients.
In the fourth quarter of 2024 we presented preclinical data at the annual meeting of the American Society of Hematology ("ASH") for RLYB332, the long-acting version of RLYB331, including favorable PD data, that support RLYB332 as a long-acting, potentially best-in-class therapy for the treatment of diseases of iron overload.
In the fourth quarter of 2024 we presented preclinical data at the annual meeting of the American Society of 2 T a b le of Contents Hematology ("ASH") for RLYB332, the long-acting version of RLYB331, including favorable PD data, that support RLYB332 as a long-acting, potentially best-in-class therapy for the treatment of diseases of iron overload.
We agree to not provide or make available any Affibody Ligand to a third-party on a standalone basis except for research purposes or to commercialize a licensed product. 19 Table of Contents We agree to use commercially reasonable efforts to develop and commercialize a licensed product.
We agree to not provide or make available any Affibody Ligand to a third-party on a standalone basis except for research purposes or to commercialize a licensed product. We agree to use commercially reasonable efforts to develop and commercialize a licensed product.
In accordance with the sunset clause, any authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market of the authorizing member state (in the case of the national, decentralized and mutual recognition procedures) within three years after the MA is granted will cease to be valid.
In accordance with the sunset clause, any authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market of the authorizing member state (in the 23 T a b le of Contents case of the national, decentralized and mutual recognition procedures) within three years after the MA is granted will cease to be valid.
Joint Venture Agreement In July 2019, we entered into a partnership with Recursion (as successor in interest to Exscientia) and created RE Ventures I, LLC ("REV-I"), which is jointly owned by Recursion and one of our wholly-owned subsidiaries, each a Member and collectively the Members.
Joint Venture Agreement In July 2019, we entered into a partnership with Recursion (as successor in interest to Exscientia) and created REV-I, which was jointly owned by Recursion and one of our wholly-owned subsidiaries, each a Member and collectively the Members.
Post-approval Requirements Following approval of a new product, the manufacturer and the approved product are subject to pervasive and continuing regulation by the FDA, governing, among other things, monitoring and recordkeeping activities, 28 Table of Contents reporting of adverse experiences with the product and product problems to the FDA, product sampling and distribution, manufacturing and promotion and advertising.
Post-approval Requirements Following approval of a new product, the manufacturer and the approved product are subject to pervasive and continuing regulation by the FDA, governing, among other things, monitoring and recordkeeping activities, 17 T a b le of Contents reporting of adverse experiences with the product and product problems to the FDA, product sampling and distribution, manufacturing and promotion and advertising.
The HTA Regulation established the Coordination Group on 37 Table of Contents HTA (the “HTACG”) consisting of representatives of EU member states, mainly from HTA authorities or bodies.
The HTA Regulation established the Coordination Group on HTA (the “HTACG”) consisting of representatives of EU member states, mainly from HTA authorities or bodies.
Health Care Laws and Regulations In the United States, biopharmaceutical manufacturers and their products are subject to extensive regulation at the federal and state level, such as laws intended to prevent fraud and abuse in the healthcare industry.
Health Care Laws and Regulations In the United States, biopharmaceutical manufacturers and their products are subject to extensive regulation at the federal and state level, such as laws intended to prevent fraud and abuse in the healthcare industry, which may constrain their business operations.
Violations of the laws may be subject to criminal and/or civil sanctions, including, in some instances, exclusion from participation in federal and state health care programs, which could adversely affect our business, financial condition, results of operations, and prospects.
Ensuring compliance is time consuming and costly. Violations of the laws may be subject to criminal and/or civil sanctions, including, in some instances, exclusion from participation in federal and state health care programs, which could adversely affect our business, financial condition, results of operations, and prospects.
Approval may require the 27 Table of Contents performance of certain clinical studies, such as clinical usability or human factors studies to demonstrate the safety and/or effectiveness of the device component of the combination product. Similar considerations apply to regulation of drugs combined with delivery systems outside the United States, including in the EU.
Approval may require the 16 T a b le of Contents performance of certain clinical studies, such as clinical usability or human factors studies to demonstrate the safety and/or effectiveness of the device component of the combination product. Similar considerations apply to regulation of drugs combined with delivery systems outside the United States, including in the EU.
Foreign Corrupt Practices Act of 1977, as amended (the "FCPA") which, among other things, prohibits U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations or foreign government-owned or affiliated entities, candidates for foreign public office, and foreign political parties or officials thereof. 38 Table of Contents Ensuring compliance is time consuming and costly.
Foreign Corrupt Practices Act of 1977, as amended (the "FCPA") which, among other things, prohibits U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations or foreign government-owned or affiliated entities, candidates for foreign public office, and foreign political parties or officials thereof.
Depending on the length of the regulatory approval process and the ability to make use of the procedures for obtaining PTE, any FDA exclusivity period may in part or in whole overlap with any patent exclusivity to which we are entitled.
Depending on the length of the regulatory approval process and the 8 T a b le of Contents ability to make use of the procedures for obtaining PTE, any FDA exclusivity period may in part or in whole overlap with any patent exclusivity to which we are entitled.
Some countries may require the completion of additional studies that compare the cost-effectiveness of our product candidate to currently available therapies (so called health technology assessment ("HTA") in order to obtain reimbursement or pricing approval).
Some countries may require the completion of additional studies that compare the cost-effectiveness of our product candidate to currently available therapies (so called health technology assessment ("HTA") in order to obtain reimbursement 25 T a b le of Contents or pricing approval).
In addition, our filings with the SEC may be accessed through the SEC’s 40 Table of Contents Interactive Data Electronic Applications system at https://www.sec.gov.
In addition, our filings with the SEC may be accessed through the SEC’s Interactive Data Electronic Applications system at https://www.sec.gov.
Privacy Law There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information, including laws requiring the safeguarding of personal information and laws requiring notification to governmental authorities and data subjects as well as remediation in the event of a data breach.
Privacy Law There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information, including laws requiring the safeguarding of personal information, laws requiring notification to governmental authorities and data subjects as well as remediation in the event of a data breach, and laws that afford individuals numerous rights with respect to their personal information.
We expect that additional federal and state health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services.
We expect that additional federal 27 T a b le of Contents and state health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services.
The success of our product candidates, if approved, is likely to be a result of their efficacy, safety, convenience, price, the level of biosimilar or generic competition and/or the availability of reimbursement from government and other third-party payors. FNAIT . There are currently no approved therapies for the prevention or treatment of FNAIT.
The success of our product candidates, if approved, is likely to be a result of their efficacy, safety, convenience, price, the level of biosimilar or generic competition and/or the availability of reimbursement from government and other third-party payors.
Under the PLA, Affibody is the exclusive owner of, and controls prosecution, maintenance, and defense of intellectual property covering, platform technology. We are the exclusive owner of, and control prosecution, maintenance, and defense of intellectual property covering, product technology.
Under the PLA, Affibody is the exclusive owner of, and controls prosecution, maintenance, and defense of intellectual property covering, platform technology. We are the exclusive owner of, and control prosecution, 9 T a b le of Contents maintenance, and defense of intellectual property covering, product technology.
The collaboration will allow Rallybio to add product candidates to its existing pipeline and also provides the option for AbCellera to conduct process development and clinical manufacturing activities. 22 Table of Contents Collaboration Agreement with Johnson & Johnson In April 2024, through Rallybio IPA, we entered into a collaboration agreement (the “J&J Collaboration Agreement”) with Johnson & Johnson, through its wholly-owned subsidiary, Momenta Pharmaceuticals, Inc.
The collaboration was designed to allow Rallybio to add product candidates to its existing pipeline and provide the option for AbCellera to conduct process development and clinical manufacturing activities. 11 T a b le of Contents Collaboration Agreement with Johnson & Johnson In April 2024, through Rallybio IPA, we entered into a collaboration agreement (the “J&J Collaboration Agreement”) with Johnson & Johnson, through its wholly-owned subsidiary, Momenta Pharmaceuticals, Inc.
In such a case, the IND sponsor and the 24 Table of Contents FDA must resolve any outstanding concerns before the clinical trial can begin.
In such a case, the IND sponsor and the 13 T a b le of Contents FDA must resolve any outstanding concerns before the clinical trial can begin.
RLYB116 was designed for optimal C5 binding, increased stability, as well as a long half-life in serum. Potential benefits of RLYB116 include: • Subcutaneous administration . The low molecular weight allows for a higher concentration of active molecules than antibodies in an equivalent volume.
We acquired rights to RLYB116 from Swedish Orphan Biovitrum AB (Publ) ("Sobi"). RLYB116 was designed for optimal C5 binding, increased stability, as well as a long half-life in serum. Potential benefits of RLYB116 include: • Subcutaneous administration . The low molecular weight allows for a higher concentration of active molecules than antibodies in an equivalent volume.
However, the TCA does not foresee wholesale mutual recognition of UK and EU pharmaceutical regulations. Rest of the World Regulation For other countries outside of the EU and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from jurisdiction to jurisdiction.
Rest of the World Regulation For other countries outside of the EU and the United States, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from jurisdiction to jurisdiction.
Mutual Recognition Procedure Under the mutual recognition procedure, the concerned member state(s) have a 90-day period to recognize the MA in the reference member state. The decentralized procedure contemplates a single clock-stop at day 105 for applicants to address questions raised by the reference member state and concerned member states, which may extend the process for completing the assessment procedure.
The decentralized procedure contemplates a single clock-stop at day 105 for applicants to address questions raised by the reference member state and concerned member states, which may extend the process for completing the assessment procedure.
European Union Regulatory Data Exclusivity In the EU, new products containing a new active substance (so called “reference medicinal products”) qualify for eight years of data exclusivity and an additional two years of marketing exclusivity upon grants of a MA.
European Union Regulatory Data Exclusivity In the EU, new products containing a new active substance are considered as “reference medicinal products,” and accordingly qualify for eight years of data exclusivity and an additional two years of marketing exclusivity upon granting of a MA.
The CCPA contains significant penalties for companies that violate its requirements and provides California residents a private right of action, including the ability to seek statutory damages, in the event of a breach involving their personal information.
The CCPA contains significant penalties for companies that violate its requirements and provides California residents a private right of action, including the ability to seek statutory damages, in the event of a breach involving their personal information. Several states have proposed or passed comprehensive privacy laws, including several laws imposing obligations similar to those of the CCPA.
Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. 35 Table of Contents The ten-year market exclusivity in the EU may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity.
The ten-year market exclusivity in the EU may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity.
Following the withdrawal of the U.K. from the EU, the U.K. Data Protection Act 2018 applies to the processing of personal data that takes place in the U.K. and includes parallel obligations to those set forth by GDPR.
Following the withdrawal of the U.K. from the EU, the U.K. Data Protection Act 2018 applies to the processing of personal data that takes place in the U.K. and includes parallel obligations to those set forth by GDPR. Employees and Human Capital Resources As of December 31, 2025, we employed 14 full-time employees.
Linkage of the Affibody domain to an ABD may lengthen the dosing interval of RLYB116 by extending the biological half-life and offer potential dosing benefits to patients. • Potentially lower risk of treatment conversion .
Linkage of the Affibody domain to an ABD may lengthen the dosing interval of RLYB116 by extending the biological half-life and offer potential dosing benefits to patients. Based on the data generated to date, we believe that RLYB116 will be administered once-weekly. • Potentially lower risk of treatment conversion .
Similar to the United States, the various phases of preclinical and clinical research in the EU are subject to significant regulatory controls. In the EU, clinical trials are primarily regulated by Regulation (EU) No 536/2014 (the “CTR”).
Similar to the United States, the various phases of preclinical and clinical research in the EU are subject to significant regulatory controls.
However, a concerned Member State may in limited circumstances declare an “opt-out” from an approval and prevent the clinical trial from being conducted in such Member State.
If successful, the resulting CTA would cover all EU Member States concerned by the application. However, a concerned Member State may in limited circumstances declare an “opt-out” from an approval and prevent the clinical trial from being conducted in such Member State.
Our team has a track record of success in designing, developing, and securing marketing approval for C5 complement inhibitors, including Soliris and Ultomiris, for patients around the world with severe and rare complement-mediated diseases. Our most advanced product candidate in this therapeutic area is RLYB116, an inhibitor of C5, which is a central component of the terminal complement pathway.
Our team has a track record of success in designing, developing, and securing marketing approval for C5 complement inhibitors, including Soliris and Ultomiris, for patients around the world with severe and rare complement-mediated diseases.
In addition, we exclusively in-license certain rights to technology from Versiti Blood Research Institute Foundation, Inc. pertaining to a mouse model of FNAIT. As of March 1, 2025, we owned two patent families relating to the current product candidates in our complement program, RLYB114 and RLYB116, and certain aspects of their use that were acquired from Sobi.
As of March 1, 2026, we owned two patent families relating to the current product candidates in our complement program, RLYB114 and RLYB116, and certain aspects of their use that were acquired from Sobi.
The applicant will receive a fee reduction for the MA application if the orphan designation has been granted, but not if the designation is still pending at the time the MA is submitted.
The applicant will receive a fee reduction for the MA application if the orphan designation has been granted, but not if the designation is still pending at the time the MA is submitted. Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
Further, we have non-exclusively in-licensed from Kymab Limited certain patent rights relating to the development, manufacture, and use of RLYB332 and the back-up compounds.
In addition, we filed and own a pending International (PCT) patent application family directed to use of RLYB332 for treating pathologies of beta-thalassemia. Further, we have non-exclusively in-licensed from Kymab Limited certain patent rights relating to the development, manufacture, and use of RLYB332 and the back-up compounds.
The reference member state prepares a draft assessment and drafts of the related materials within 120 days of the receipt of a valid application. Within 90 days of receiving the reference member state’s positive assessment report, each concerned member state must approve the assessment report and related materials, unless they identify a potential serious risk to public health.
Within 90 days of receiving the reference member state’s positive assessment report, each concerned member state must approve the assessment report and related materials, unless they identify a potential serious risk to public health. Mutual Recognition Procedure Under the mutual recognition procedure, the concerned member state(s) have a 90-day period to recognize the MA in the reference member state.
We consider our relationship with our employees to be good. Corporate Information Rallybio was founded in 2018. Rallybio Holdings, LLC ("Rallybio Holdings") was formed in Delaware in March 2018 and Rallybio IPD, LLC was formed in Delaware in May 2020. On June 30, 2021, Rallybio IPD, LLC was converted into a Delaware corporation and changed its name to Rallybio Corporation.
We consider our relationship with our employees to be good. 28 T a b le of Contents Corporate Information Rallybio was founded in 2018. Rallybio Holdings, LLC ("Rallybio Holdings") was formed in Delaware in March 2018 and Rallybio IPD, LLC was formed in Delaware in May 2020.
Antibody inhibitors of C5 have been successfully developed to treat diseases caused by complement pathway dysregulation, including PNH, aHUS, refractory gMG and relapsing NMOSD. Despite the approval of antibody-based C5 inhibitors for patients with these diseases, we believe there remains a significant need in the market for safe, effective, patient-friendly, and accessible therapies.
Despite the approval of antibody-based C5 inhibitors for patients with these diseases, we believe there remains a significant need in the market for safe, effective, patient-friendly, and accessible therapies.
This law imposes obligations related to the collection and sharing of certain health-related information that is not subject to HIPAA and that does not fall within certain other exceptions in the law. Other states have enacted, or are in the process of enacting, similar health-focused consumer privacy laws.
In addition, several states have proposed or enacted health-focused consumer privacy laws, such as Washington state's My Health, My Data Act, which took effect in March 2024, and imposes obligations related to the collection and sharing of certain health-related information that is not subject to HIPAA and that does not fall within certain other exceptions in the law.
Our principal executive offices are located at 234 Church Street, Suite 1020, New Haven, CT 06510 and our telephone number is (203) 859-3820. Our corporate website address is https://www.rallybio.com.
On June 30, 2021, Rallybio IPD, LLC was converted into a Delaware corporation and changed its name to Rallybio Corporation. Our principal executive offices are located at 234 Church Street, New Haven, CT 06510 and our telephone number is (203) 859-3820. Our corporate website address is https://www.rallybio.com.
The planned confirmatory trial is summarized below: Planned Confirmatory Multiple Ascending Dose Phase 1 Clinical Trial of RLYB116 in Healthy Participants Based on market research conducted to date, we believe that an effective, once-weekly, well-tolerated therapy that can be rapidly self-administered with an autoinjector would be an attractive alternative for patients suffering from gMG and other complement mediated diseases.
Based on market research conducted to date, we believe that an effective, once-weekly, well-tolerated therapy that can be rapidly self-administered with an autoinjector would be an attractive alternative for patients suffering from a wide array of complement mediated diseases.
The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis. We believe this molecule has the potential to address a significant unmet need for 14 Table of Contents patients with severe anemias with ineffective erythropoiesis and iron overload, including beta thalassemia and a subset of lower risk MDS.
We believe this molecule has the potential to address a significant unmet need for patients with severe anemias with ineffective erythropoiesis and iron overload, including beta thalassemia and a subset of lower risk MDS. Currently these patients are underserved by the existing standard of care.
We achieve this, in part, through the use of confidentiality agreements with our employees, consultants, scientific advisors, collaborators, licensors, and contractors, and by striving to maintain physical security of our premises and digital security of our electronic information and technology systems. 17 Table of Contents Notwithstanding our commitment to protecting our intellectual property rights, we, like other pharmaceutical and biopharmaceutical companies, are subject to several sources of uncertainty that can affect those rights.
We achieve this, in part, through the use of confidentiality agreements with our employees, consultants, scientific advisors, collaborators, licensors, and contractors, and by striving to maintain physical security of our premises and digital security of our electronic information and technology systems.
Additionally, the clinical trials must be conducted in accordance with current good clinical practice requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. 36 Table of Contents If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.
Treatment of Disorders Due to Complement Dysregulation The complement system plays a central role in innate immunity, as well as, shaping adaptive immune response. Dysregulation of the complement pathway has been implicated in the pathogenesis of a growing number of diseases, making it an attractive target for therapeutic intervention.
Dysregulation of the complement pathway has been implicated in the pathogenesis of a growing number of diseases, making it an attractive target for therapeutic intervention.
These findings, which were presented in a poster at the 66th annual meeting of ASH, support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload.
In 2024, we completed non-clinical studies that demonstrated favorable tolerability, dose-dependent PK, and sustained PD effects with RLYB332, a long-acting version of RLYB331. These findings, which were presented in a poster at the 66th annual meeting of ASH, support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload.
RLYB116 is an Affibody molecule attached to an albumin binding domain ("ABD") that has the potential to drive the rapid, complete, and sustained inhibition of C5 with a SC injection. We have completed a Phase 1 clinical trial in healthy participants that included the study of RLYB116 as both a single ascending dose (“SAD”) and a multiple ascending dose (“MAD”).
RLYB116 is an Affibody molecule attached to an albumin binding domain ("ABD") that has the potential to drive the rapid, complete, and sustained inhibition of C5 with a subcutaneous ("SC") injection.
EU regulatory regime contemplates that MAs can be granted either centrally or nationally, albeit through mutual recognition or decentralized procedure.
EU regulatory regime contemplates that MAs can be granted either centrally or nationally, albeit through mutual recognition or decentralized procedure, depending on the type of product and the therapeutic indications for which approval is being sought.
The CTR requires sponsors to submit one clinical trial authorization (“CTA”) application via the Clinical Trials Information System, which will then be reviewed by the competent regulatory agency selected by the sponsor to lead the validation and evaluation of the application. If successful, the resulting CTA would cover all EU Member States concerned by the application.
In the EU, clinical trials are primarily regulated by Regulation (EU) No 536/2014 (the “CTR”). 20 T a b le of Contents The CTR requires sponsors to submit one clinical trial authorization (“CTA”) application via the Clinical Trials Information System, which will then be reviewed by the competent regulatory agency selected by the sponsor as the reporting Member State to lead the validation and evaluation of the application.
Our research collaboration with EyePoint Pharmaceuticals to evaluate delivery of RLYB114 using EyePoint’s technology for sustained intraocular drug delivery ended in January 2025. RLYB332 for the treatment of severe anemia with ineffective erythropoiesis and iron overload In May 2022, we obtained worldwide exclusive rights to RLYB331, a preclinical antibody designed to inhibit MTP-2.
RLYB332 for the treatment of severe anemia with ineffective erythropoiesis and iron overload In May 2022, we obtained worldwide exclusive rights to RLYB331, a preclinical antibody designed to inhibit MTP-2. The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis.

… 325 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

195 edited+133 added−76 removed417 unchanged
Biggest changeRisks Related to Healthcare Laws and Other Legal Compliance Matters Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set.
Biggest changeRisks Related to Healthcare Laws and Other Legal Compliance Matters If we continue to progress the development of our product candidates, enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set. 61 T a b le of Contents In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes, and additional proposed changes, to the healthcare system that could affect our future results of operations.
If we conduct clinical trial programs in the EEA or UK (whether the trials are conducted directly by us or through a clinical vendor or collaborator) or enter into research collaborations involving the monitoring of individuals in the EEA or UK, or market our products to individuals in the EEA or UK, we will be subject to the GDPR or UK GDPR, as applicable, which place stringent operational requirements for processors and controllers of personal data of individuals in the EEA and UK, respectively.
If we conduct clinical trial programs in the EEA or UK (whether the trials are conducted directly by us or through a clinical vendor or collaborator), enter into research collaborations involving the monitoring of individuals in the EEA or UK, or market our products to individuals in the EEA or UK, we will be subject to the GDPR or UK GDPR, as applicable, which place stringent operational requirements for processors and controllers of personal data of individuals in the EEA and UK, respectively.
For example: ▪ we or our license partners or current or future collaborators might not have been the first to file patent applications covering our or their inventions; ▪ others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ▪ it is possible that our pending or future patent applications will not lead to issued patents; ▪ issued patents that we hold rights to may be held invalid or unenforceable; ▪ our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ▪ we cannot ensure that any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our product candidates; ▪ we cannot ensure that any patents issued to us will provide a basis for an exclusive market for our commercially viable product candidates or will provide us with any competitive advantages; ▪ we cannot ensure that our commercial activities or product candidates will not infringe upon the patents of others; ▪ we cannot ensure that we will be able to successfully commercialize our product candidates on a substantial scale, if approved, before the relevant patents that we own or license expire; ▪ we may not develop additional proprietary technologies that are patentable; ▪ the patents of others may harm our business; and 80 Table of Contents ▪ we may choose not to seek patent protection in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such intellectual property.
For example: ▪ we or our license partners or current or future collaborators might not have been the first to file patent applications covering our or their inventions; ▪ others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ▪ it is possible that our pending or future patent applications will not lead to issued patents; ▪ issued patents that we hold rights to may be held invalid or unenforceable; ▪ our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ▪ we cannot ensure that any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our product candidates; ▪ we cannot ensure that any patents issued to us will provide a basis for an exclusive market for our commercially viable product candidates or will provide us with any competitive advantages; ▪ we cannot ensure that our commercial activities or product candidates will not infringe upon the patents of others; ▪ we cannot ensure that we will be able to successfully commercialize our product candidates on a substantial scale, if approved, before the relevant patents that we own or license expire; ▪ we may not develop additional proprietary technologies that are patentable; ▪ the patents of others may harm our business; and ▪ we may choose not to seek patent protection in order to maintain certain trade secrets or know-how, and a third-party may subsequently file a patent covering such intellectual property.
We have completed Phase 1 clinical studies for RLYB212 and RLYB116, however, even if we complete later clinical trials as planned, we cannot be certain that their results will support the safety and efficacy requirements sufficient to obtain regulatory approval, and, as a result, our clinical development plans may be materially harmed.
We have completed Phase 1 clinical studies for RLYB116, however, even if we complete later clinical trials as planned, we cannot be certain that their results will support the safety and efficacy requirements sufficient to obtain regulatory approval, and, as a result, our clinical development plans may be materially harmed.
If our competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as RLYB212 and RLYB116 or any of our other product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
If our competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as RLYB116 or any of our other product candidates, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
On March 27, 2020, former President Trump signed into law the CARES Act, which included certain changes in tax law intended to stimulate the U.S. economy in light of the COVID-19 pandemic, including temporary beneficial changes to the treatment of NOLs, interest deductibility limitations and payroll tax matters.
On March 27, 2020, President Trump signed into law the CARES Act, which included certain changes in tax law intended to stimulate the U.S. economy in light of the COVID-19 pandemic, including temporary beneficial changes to the treatment of NOLs, interest deductibility limitations and payroll tax matters.
This estimate and our expectation to advance the preclinical and clinical development of RLYB212, RLYB116, and any other product candidates are based on assumptions that may prove to be wrong, or we may be subject to changing circumstances. We could exhaust our available capital resources sooner than we expect.
This estimate and our expectation to advance the preclinical and clinical development of RLYB116 and any other product candidates are based on assumptions that may prove to be wrong, or we may be subject to changing circumstances. We could exhaust our available capital resources sooner than we expect.
Additionally, we may have difficulty identifying and enrolling patients for our planned clinical trials because the conditions for which we plan to evaluate our current product candidates are rare diseases and we anticipate that there will be limited patient pools from which to draw for clinical trials.
Additionally, we may have difficulty identifying and enrolling patients for any planned clinical trials because the conditions for which we plan to evaluate our current product candidates are rare diseases and we anticipate that there will be limited patient pools from which to draw for clinical trials.
Various factors will influence whether our product candidates are accepted in the market if approved for commercial sale, including, but not limited to: ▪ the efficacy, safety and tolerability of our products, and potential advantages compared to alternative treatments; ▪ the clinical indications for which the product is approved, and product labeling or product insert requirements of the FDA, EMA or other comparable foreign regulatory authorities, including any limitations or warnings contained in a product’s approved labeling; ▪ the effectiveness of sales and marketing efforts; ▪ the prevalence and severity of any side effects; ▪ the cost of treatment in relation to alternative treatments, including any similar treatments; ▪ our ability to offer our products for sale at competitive prices; ▪ the availability and access to screening and/or diagnostic tests; ▪ the convenience and ease of administration compared to alternative treatments; ▪ the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ▪ the strength of marketing and distribution support; ▪ the availability of third-party coverage and reimbursement for any of our products that are approved and any screening and/or diagnostic testing, as appropriate; and 61 Table of Contents ▪ any restrictions on the use of our product together with other medications.
Various factors will influence whether our product candidates are accepted in the market if approved for commercial sale, including, but not limited to: ▪ the efficacy, safety and tolerability of our products, and potential advantages compared to alternative treatments; ▪ the clinical indications for which the product is approved, and product labeling or product insert requirements of the FDA, EMA or other comparable foreign regulatory authorities, including any limitations or warnings contained in a product’s approved labeling; ▪ the effectiveness of sales and marketing efforts; ▪ the prevalence and severity of any side effects; ▪ the cost of treatment in relation to alternative treatments, including any similar treatments; ▪ our ability to offer our products for sale at competitive prices; ▪ the availability and access to screening and/or diagnostic tests; ▪ the convenience and ease of administration compared to alternative treatments; ▪ the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ▪ the strength of marketing and distribution support; ▪ the availability of third-party coverage and reimbursement for any of our products that are approved and any screening and/or diagnostic testing, as appropriate; and ▪ any restrictions on the use of our product together with other medications.
Our amended and restated certificate of incorporation and bylaws include provisions that: ▪ authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock; ▪ create a classified board of directors whose members serve staggered three-year terms; ▪ specify that special meetings of our stockholders can be called only by our board of directors; ▪ prohibit stockholder action by written consent; 85 Table of Contents ▪ establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; ▪ provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; ▪ provide that our directors may be removed only for cause; ▪ specify that no stockholder is permitted to cumulate votes at any election of directors; ▪ expressly authorize our board of directors to modify, alter or repeal our amended and restated bylaws; and ▪ require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated bylaws.
Our amended and restated certificate of incorporation and bylaws include provisions that: ▪ authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock; ▪ create a classified board of directors whose members serve staggered three-year terms; ▪ specify that special meetings of our stockholders can be called only by our board of directors; ▪ prohibit stockholder action by written consent; ▪ establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; ▪ provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; ▪ provide that our directors may be removed only for cause; ▪ specify that no stockholder is permitted to cumulate votes at any election of directors; ▪ expressly authorize our board of directors to modify, alter or repeal our amended and restated bylaws; and ▪ require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated bylaws.
In addition, we have entered into the Sales Agreement with Cowen to offer and sell shares of our common stock having an aggregate offering price of up to $100,000,000, from time to time, through an at-the-market offering program.
In addition, we have entered into the Sales Agreement with TD Cowen to offer and sell shares of our common stock having an aggregate offering price of up to $100,000,000, from time to time, through an at-the-market offering program.
Sponsors of fast-track products may have more frequent interactions with the FDA, and, in some circumstances, the FDA may initiate review of sections of a fast track product’s application before the application is complete. We may submit an application for Fast Track designation for RLYB212 and RLYB116.
Sponsors of fast-track products may have more frequent interactions with the FDA, and, in some circumstances, the FDA may initiate review of sections of a fast track product’s application before the application is complete. We may submit an application for Fast Track designation for RLYB116.
FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products prior to approval or for off-label use and regulates the distribution of samples; ▪ U.S. federal laws that require pharmaceutical manufacturers to calculate, report and certify certain complex product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; ▪ U.S. federal Open Payments (or federal “sunshine” law), which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with certain healthcare providers to CMS for re-disclosure to the public, as well as ownership and investment interests held by physicians and their immediate family members; ▪ U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; ▪ analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws; state laws requiring pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or report information related to payments to health care providers, marketing expenditures or drug prices; state and local laws requiring the registration of pharmaceutical sales representatives; state laws regulating the manufacture and distribution of biopharmaceutical products; and state laws governing privacy, security, and breaches of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; ▪ U.S. laws and regulations prohibiting bribery and corruption, such as the U.S.
FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products prior to approval or for off-label use and regulates the distribution of samples; ▪ U.S. federal laws that require pharmaceutical manufacturers to calculate, report and certify certain complex product prices to the government or provide certain discounts or rebates to government 63 T a b le of Contents authorities or private entities, often as a condition of reimbursement under government healthcare programs; ▪ U.S. federal Open Payments (or federal “sunshine” law), which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with certain healthcare providers to CMS for re-disclosure to the public, as well as ownership and investment interests held by physicians and their immediate family members; ▪ U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; ▪ analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws; state laws requiring pharmaceutical companies to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers or report information related to payments to health care providers, marketing expenditures or drug prices; state and local laws requiring the registration of pharmaceutical sales representatives; state laws regulating the manufacture and distribution of biopharmaceutical products; and state laws governing privacy, security, and breaches of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; ▪ U.S. laws and regulations prohibiting bribery and corruption, such as the U.S.
Even if we successfully commercialize RLYB212, RLYB116 or any of our other product candidates, we may continue to incur substantial research and development and other expenses to develop other current or future product candidates.
Even if we successfully commercialize RLYB116 or any of our other product candidates, we may continue to incur substantial research and development and other expenses to develop other current or future product candidates.
We may not realize the anticipated benefits of any current or future collaboration, each of which involves or will involve numerous risks, including: ▪ a collaborator may shift its priorities and resources away from our product candidates due to a change in business strategies, or a merger, acquisition, sale, or downsizing; ▪ a collaborator may seek to renegotiate or terminate its relationships with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; ▪ a collaborator may cease development in therapeutic areas that are the subject of our collaboration; ▪ a collaborator may not devote sufficient capital or resources towards our product candidates, or may fail to comply with applicable regulatory requirements; ▪ a collaborator may change the success criteria for a product candidate, thereby delaying or ceasing development of such candidate; ▪ a significant delay in initiation of certain development activities by a collaborator will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; ▪ a collaborator could develop a product that competes, either directly or indirectly, with our product candidates; ▪ a collaborator with commercialization obligations may not commit sufficient financial resources or personnel to the marketing, distribution, or sale of a product; ▪ a collaborator with manufacturing responsibilities may encounter regulatory, resource, or quality issues and be unable to meet demand requirements; ▪ a collaborator may terminate a strategic alliance; ▪ a dispute may arise between us and a collaborator concerning the research, development, or commercialization of a product candidate resulting in a delay in milestones or royalty payments or termination of the relationship and possibly resulting in costly litigation or arbitration, which may divert management’s attention and resources; and ▪ a collaborator may use our products or technology in such a way as to invite litigation from a third-party.
We may not realize the anticipated benefits of any current or future collaboration, each of which involves or will involve numerous risks, including: ▪ a collaborator may shift its priorities and resources away from our product candidates due to a change in business strategies, or a merger, acquisition, sale, or downsizing; ▪ a collaborator may seek to renegotiate or terminate its relationship with us due to unsatisfactory clinical results, manufacturing issues, a change in business strategy, a change of control or other reasons; ▪ a collaborator may cease development in therapeutic areas that are the subject of our collaboration; ▪ a collaborator may not devote sufficient capital or resources towards our product candidates, or may fail to comply with applicable regulatory requirements; ▪ a collaborator may change the success criteria for a product candidate, thereby delaying or ceasing development of such candidate; 57 T a b le of Contents ▪ a significant delay in initiation of certain development activities by a collaborator will also delay payment of milestones tied to such activities, thereby impacting our ability to fund our own activities; ▪ a collaborator could develop a product that competes, either directly or indirectly, with our product candidates; ▪ a collaborator with commercialization obligations may not commit sufficient financial resources or personnel to the marketing, distribution, or sale of a product; ▪ a collaborator with manufacturing responsibilities may encounter regulatory, resource, or quality issues and be unable to meet demand requirements; ▪ a collaborator may terminate a strategic alliance; ▪ a dispute may arise between us and a collaborator concerning the research, development, or commercialization of a product candidate resulting in a delay in milestones or royalty payments or termination of the relationship and possibly resulting in costly litigation or arbitration, which may divert management’s attention and resources; and ▪ a collaborator may use our products or technology in such a way as to invite litigation from a third-party.
If any such actions are instituted against us or them and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal, and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs or healthcare 65 Table of Contents programs in other jurisdictions, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
If any such actions are instituted against us or them and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal, and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs or healthcare programs in other jurisdictions, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
Doing business internationally involves several risks, including, but not limited to: ▪ multiple, conflicting, and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, economic sanctions laws and regulations, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses; ▪ failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ▪ additional potentially relevant third-party patent rights; ▪ complexities and difficulties in obtaining protection and enforcing our intellectual property; ▪ difficulties in staffing and managing foreign operations; ▪ complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay systems; ▪ limits in our ability to penetrate international markets; ▪ financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products, and exposure to foreign currency exchange rate fluctuations; ▪ natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions; ▪ certain expenses, including, among others, expenses for travel, translation, and insurance; and ▪ regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the FCPA its books and records provisions, or its anti-bribery provisions, as well as other applicable laws and regulations prohibiting bribery and corruption.
Doing business internationally involves several risks, including, but not limited to: ▪ multiple, conflicting, and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, economic sanctions laws and regulations, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses; ▪ failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ▪ additional potentially relevant third-party patent rights; ▪ complexities and difficulties in obtaining protection and enforcing our intellectual property; ▪ difficulties in staffing and managing foreign operations; ▪ complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay systems; ▪ limits in our ability to penetrate international markets; ▪ financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products, and exposure to foreign currency exchange rate fluctuations; ▪ natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, tariffs, curtailment of trade, and other business restrictions; ▪ certain expenses, including, among others, expenses for travel, translation, and insurance; and 81 T a b le of Contents ▪ regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the FCPA its books and records provisions, or its anti-bribery provisions, as well as other applicable laws and regulations prohibiting bribery and corruption.
Most recently, on July 16, 2020, the Court of Justice of the European Union ("CJEU") invalidated the EU-US Privacy Shield Framework (the "Privacy Shield") under which personal data could be transferred from the EEA to US entities who had self-certified under the Privacy Shield scheme. This framework has been replaced by the E.U.-U.S.
On July 16, 2020, the Court of Justice of the European Union ("CJEU") invalidated the EU-US Privacy Shield Framework (the "Privacy Shield") under which personal data could be transferred from the EEA to US entities who had self-certified under the Privacy Shield scheme. This framework has been replaced by the E.U.-U.S.
If the FDA, EMA or other comparable foreign regulatory authority 66 Table of Contents finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval or finds deficiencies in the future, we may need to find alternative manufacturing facilities or conduct additional studies, which would delay our development program and significantly impact our ability to develop, obtain regulatory approval for, or commercialize our product candidates, if approved.
If the FDA, EMA or other comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval or finds deficiencies in the future, we may need to find alternative manufacturing facilities or conduct additional studies, which would delay our development program and significantly impact our ability to develop, obtain regulatory approval for, or commercialize our product candidates, if approved.
Moreover, as of December 31, 2024, certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
Moreover, as of December 31, 2025, certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
The Budget Control Act, as amended, resulted in the imposition of reductions in Medicare (but not Medicaid) payments to providers in 2013 and will remain in effect through 2032 unless additional Congressional action is taken.
As another example, the Budget Control Act, as amended, resulted in the imposition of reductions in Medicare (but not Medicaid) payments to providers in 2013 and will remain in effect through 2032 unless additional Congressional action is taken.
If our or our collaborators’ or service providers’ privacy or data security measures fail to comply with the GDPR or UK GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data, or fines of up to 20 million Euros in the case of GDPR or £17.5 million in the case of UK GDPR or, in each case, up to 4% of our total worldwide annual revenue of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, including class-action type litigation, negative publicity, reputational harm and a potential loss of business and goodwill.
If our or our collaborators’ or service providers’ privacy or data security measures fail to comply with the GDPR or UK GDPR requirements, we may be subject to litigation, regulatory investigations, enforcement notices requiring us to change the way we use personal data, temporary or definitive bans on data processing, or fines of up to 20 million Euros in the case of GDPR or £17.5 million in the case of UK GDPR or, in each case, up to 4% of our total worldwide annual revenue of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, including class-action type litigation, negative publicity, reputational harm and a potential loss of business and goodwill.
If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical development, manufacturing, or commercialization efforts related to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or activities that would 64 Table of Contents otherwise have been the responsibility of our collaborator.
If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical development, manufacturing, or commercialization efforts related to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or activities that would otherwise have been the responsibility of our collaborator.
Furthermore, all fifty U.S. states, the District of Columbia, Puerto Rico, and other U.S. territories have enacted data breach notification laws that require, among other things, notifications to state governments and/or the affected individuals in the event of a data breach, which differ from one another and impose significant compliance burden.
Furthermore, all fifty U.S. states, the District of Columbia, Puerto Rico, and other U.S. territories have enacted data breach notification laws that require, among other things, notifications to state governments and/or the affected individuals in the event of a data breach. Such laws differ from one another, and may impose significant compliance burden.
In comparison, European patents that are not under the jurisdiction of the UPC must be litigated separately in each member state, which causes patent challengers to incur additional costs and leaves open the possibility that a 74 Table of Contents challenged patent could be affirmed in some member states, even if it is invalidated in others.
In comparison, European patents that are not under the jurisdiction of the UPC must be litigated separately in each member state, which causes patent challengers to incur additional costs and leaves open the possibility that a challenged patent could be affirmed in some member states, even if it is invalidated in others.
Furthermore, pursuant to General Instruction I.B.6 to Form S-3 (“Instruction I.B.6”), a company with a public float of less than $75 million measured at certain time periods may not issue securities under Registration Statements on Form S-3 in excess of one-third of its public float in a 12-month period.
Furthermore, pursuant to Instruction I.B.6, a company with a public float of less than $75 million measured at certain time periods may not issue securities under Registration Statements on Form S-3 in excess of one-third of its public float in a 12-month period.
In addition, even if RLYB212 qualifies as a Breakthrough Therapy, the FDA may later decide that RLYB212 no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In the EU we may seek PRIME designation for some of our product candidates in the future.
In addition, even if a product candidate qualifies as a Breakthrough Therapy, the FDA may later decide that such product candidate no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In the EU we may seek PRIME designation for some of our product candidates in the future.
In the EU, the EMA’s Committee for Orphan Medicinal Products evaluates, and the European Commission grants, an orphan drug designation principally to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.
In the EU, the EMA’s Committee for Orphan Medicinal Products evaluates, and the EC grants, an orphan drug designation principally to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.
Our amended and restated certificate of incorporation provides that, subject to limited exceptions, the state or federal courts (as appropriate) within the State of Delaware are exclusive forums for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (3) any action asserting a claim against us arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws, (4) action against us or any of our directors or officers involving a claim or defense arising pursuant to the Exchange Act or the Securities Act, or (5) any other action asserting a claim against us that is governed by the internal affairs doctrine.
Our amended and restated certificate of incorporation provides that, subject to limited exceptions, the state or federal courts (as appropriate) within the State of Delaware are exclusive forums for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of 80 T a b le of Contents our directors, officers or other employees to us or our stockholders, (3) any action asserting a claim against us arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws, (4) action against us or any of our directors or officers involving a claim or defense arising pursuant to the Exchange Act or the Securities Act, or (5) any other action asserting a claim against us that is governed by the internal affairs doctrine.
Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from 76 Table of Contents competitive products, including generics or biosimilars.
Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars.
These estimates have been derived from a variety of sources, including scientific literature, population statistics and market research, and may prove to be incorrect. Further, new sources may reveal a change in the estimated number of eligible patients, and the number of patients may turn out to be 53 Table of Contents lower than expected.
These estimates have been derived from a variety of sources, including scientific literature, population statistics and market research, and may prove to be incorrect. Further, new sources may reveal a change in the estimated number of eligible patients, and the number of patients may turn out to be lower than expected.
We may seek accelerated approval by the FDA for one or more of our product candidates. Accelerated approval by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
Accelerated approval by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval. We may in the future seek an accelerated approval for our one or more of our product candidates.
The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Global Select Market, and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Capital Market, and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
The FDA, EMA or other comparable foreign regulatory authority can delay, limit, or deny approval of RLYB212, RLYB116 or any of our other product candidates that we develop or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including, but not limited to: ▪ the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ▪ we may be unable to demonstrate to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities that our product candidate is safe and effective for its proposed indication; 52 Table of Contents ▪ serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates, or other products containing an active ingredient in our product candidates; ▪ negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA, EMA or other comparable foreign regulatory authorities for approval; ▪ the population studied in the clinical trial may not be sufficiently broad or representative to assure safety and efficacy in the full population for which we seek approval; ▪ the FDA, EMA or other comparable foreign regulatory authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that of the United States or the applicable foreign jurisdiction; ▪ we may be unable to demonstrate that our product candidate’s clinical and other benefits outweigh its safety risks; ▪ the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ▪ the data collected from clinical trials of our product candidates may not be acceptable or sufficient to support the submission of a BLA or NDA or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; ▪ the FDA’s or the applicable foreign regulatory authority’s disagreement regarding the formulation, the labeling, and/or the specifications of our product candidates; ▪ the FDA, EMA, or other comparable foreign regulatory authorities may require us to obtain clearance or approval of a companion diagnostic test; ▪ additional time may be required to obtain regulatory approval for our product candidates because they are combination products; ▪ the FDA, EMA or other comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ▪ the policies, regulations, and guidelines of the FDA, EMA or other comparable foreign regulatory authorities regarding the development, approval, and marketing of drugs and biologics may significantly change, including but not limited to, in the U.S., as a result of the 2025 change in presidential administration, which may render our clinical data insufficient for approval or restrict us from marketing our product candidates in the manner in which we anticipate.
If we continue to progress the development of our product candidates, the FDA, EMA or other comparable foreign regulatory authority can delay, limit, or deny approval of RLYB116 or any of our other product candidates that we develop or require us to conduct additional preclinical or clinical testing or abandon a program for many reasons, including, but not limited to: ▪ the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; ▪ we may be unable to demonstrate to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities that our product candidate is safe and effective for its proposed indication; ▪ serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates, or other products containing an active ingredient in our product candidates; ▪ negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA, EMA or other comparable foreign regulatory authorities for approval; 47 T a b le of Contents ▪ the population studied in the clinical trial may not be sufficiently broad or representative to assure safety and efficacy in the full population for which we seek approval; ▪ the FDA, EMA or other comparable foreign regulatory authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that of the United States or the applicable foreign jurisdiction; ▪ we may be unable to demonstrate that our product candidate’s clinical and other benefits outweigh its safety risks; ▪ the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ▪ the data collected from clinical trials of our product candidates may not be acceptable or sufficient to support the submission of a BLA or NDA or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; ▪ the FDA’s or the applicable foreign regulatory authority’s disagreement regarding the formulation, the labeling, and/or the specifications of our product candidates; ▪ additional time may be required to obtain regulatory approval for our product candidates because they are combination products; ▪ the FDA, EMA or other comparable foreign regulatory authorities may fail to approve or find deficiencies with the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and ▪ the policies, regulations, and guidelines of the FDA, EMA or other comparable foreign regulatory authorities regarding the development, approval, and marketing of drugs and biologics may significantly change, including but not limited to, in the U.S., as a result of the 2025 change in presidential administration, which may render our clinical data insufficient for approval or restrict us from marketing our product candidates in the manner in which we anticipate.
To the extent that we raise additional capital through the future sale of equity or convertible debt securities, including sales of our common stock pursuant to the Sales Agreement with Cowen and Company, LLC, each shareholder's ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect their rights as a common stockholder.
To the extent that we raise additional capital through the future sale of equity or convertible debt securities, including sales of our common stock pursuant to the Sales Agreement with TD Securities (USA) LLC, each shareholder's ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect their rights as a common stockholder.
In 58 Table of Contents addition, the product under consideration is indicated for a condition where there exists no satisfactory method of diagnosis, prevention or treatment authorized in the EU or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.
In addition, the product under consideration is indicated for a condition where there exists no satisfactory method of diagnosis, prevention or treatment authorized in the EU or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.
Any failure to follow cGMP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our product candidates as a result of a failure of our facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our product candidates, including leading to significant delays in the availability of our product candidates for our clinical trials or the termination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applications for our product candidates.
Any failure to follow cGMP or other regulatory requirements or delay, interruption or other 59 T a b le of Contents issues that arise in the manufacture, fill-finish, packaging, or storage of our product candidates as a result of a failure of our facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our product candidates, including leading to significant delays in the availability of our product candidates for our clinical trials or the termination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applications for our product candidates.
In addition, regardless of merit or eventual outcome, clinical trial or product liability claims may result in: ▪ impairment of our business reputation and significant negative media attention; ▪ withdrawal of participants from our clinical trials; ▪ significant costs to defend the litigation; ▪ distraction of management’s attention from our primary business; ▪ substantial monetary awards to patients or other claimants; ▪ inability to commercialize a product candidate; ▪ product recalls, withdrawals or labeling, marketing or promotional restrictions; ▪ decreased market demand for any product; and ▪ loss of revenue.
In addition, regardless of merit or eventual outcome, clinical trial or product liability claims may result in: ▪ impairment of our business reputation and significant negative media attention; ▪ withdrawal of participants from our clinical trials; ▪ significant costs to defend the litigation; ▪ distraction of management’s attention from our primary business; ▪ substantial monetary awards to patients or other claimants; ▪ inability to commercialize a product candidate; 82 T a b le of Contents ▪ product recalls, withdrawals or labeling, marketing or promotional restrictions; ▪ decreased market demand for any product; and ▪ loss of revenue.
The size of our centralized team may limit our ability to devote adequate personnel, time, and resources to support the operations of all of our subsidiaries and the Recursion joint venture, including their research and development activities, the management of financial, accounting, and reporting matters, and the oversight of our third-party vendors and partners.
The size of our centralized team may limit our ability to devote adequate personnel, time, and resources to support the operations of all of our subsidiaries, including their research and development activities, the management of financial, accounting, and reporting matters, and the oversight of our third-party vendors and partners.
Factors relating to our business that may contribute to these fluctuations include the following, as well as other factors described elsewhere in this Annual Report on Form 10-K: ▪ variations in the level of expense related to the ongoing development of our product candidates or research pipeline; ▪ delays or failures in advancement of existing or future product candidates into the clinic or in clinical trials; ▪ the feasibility of developing, manufacturing and commercializing our product candidates; ▪ our relationships, and any associated exclusivity terms, with strategic collaborators; 44 Table of Contents ▪ our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements, or the termination or modification of any such existing or future arrangements; ▪ our operation in a net loss position in the foreseeable future; ▪ our ability, ourselves or with collaborators, to develop a companion diagnostic, if required, and obtain marketing approval; ▪ our ability to consistently manufacture our product candidates, including in sufficient quantities for clinical or commercial purposes; ▪ our dependence on, and the need to attract and retain, key management and other personnel; ▪ strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; ▪ potential advantages that our competitors and potential competitors may have in developing and commercializing competing products, securing funding for or obtaining the rights to critical intellectual property; ▪ regulatory developments affecting our product candidates or those of our competitors; ▪ if any of our product candidates receives regulatory approval, the terms of such approval and market acceptance and demand for such product candidates; ▪ developments or disputes concerning patents or other proprietary rights, litigation matters and our ability to obtain and maintain patent protection for our product candidates; ▪ business interruptions such as power outages, strikes, civil unrest, wars, acts of terrorism or natural disasters; and ▪ our ability to use our net operating loss ("NOL") and income tax credit carryforwards to offset income tax.
Factors relating to our business that may contribute to these fluctuations include the following, as well as other factors described elsewhere in this Annual Report on Form 10-K: ▪ variations in the level of expense related to any ongoing development of our product candidates or research pipeline; ▪ delays or failures in advancement of any existing or future product candidates into the clinic or in clinical trials; ▪ the feasibility of developing, manufacturing and commercializing our product candidates; ▪ our relationships, and any associated exclusivity terms, with strategic collaborators; ▪ our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements, or the termination or modification of any such existing or future arrangements; 39 T a b le of Contents ▪ our operation in a net loss position in the foreseeable future; ▪ if we continue to progress the development of our product candidates, our ability to consistently manufacture our product candidates, including in sufficient quantities for clinical or commercial purposes; ▪ our dependence on, and the need to attract and retain, key management and other personnel; ▪ strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; ▪ potential advantages that our competitors and potential competitors may have in developing and commercializing competing products, securing funding for or obtaining the rights to critical intellectual property; ▪ regulatory developments affecting our product candidates or those of our competitors; ▪ if any of our product candidates receives regulatory approval, the terms of such approval and market acceptance and demand for such product candidates; ▪ developments or disputes concerning patents or other proprietary rights, litigation matters and our ability to obtain and maintain patent protection for our product candidates; ▪ business interruptions such as power outages, strikes, civil unrest, wars, acts of terrorism or natural disasters; and ▪ our ability to use our net operating loss ("NOL") and income tax credit carryforwards to offset income tax.
We currently rely and will rely on third parties for the manufacture of drug substance and drug product for our preclinical studies and clinical trials and expect to continue to do so for commercialization of any product candidates that we may develop that are approved for marketing.
We currently rely and will rely on third parties for the manufacture of drug substance and drug product for our preclinical studies and clinical trials and, if we continue to progress the development of our product candidates, expect to continue to do so for commercialization of any product candidates that we may develop that are approved for marketing.
Some of the factors that may cause the market price of our common stock to fluctuate include: ▪ the success of existing or new competitive product candidates or technologies; ▪ the timing and results of preclinical studies for any product candidates that we may develop; ▪ failure or discontinuation of any of our product development and research programs; ▪ the success of the development of companion diagnostics, if required, for use with our product candidates; ▪ results of preclinical studies, clinical trials, or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors; ▪ commencement or termination of collaborations for our product development and research programs; ▪ regulatory or legal developments in the United States and other countries; ▪ developments or disputes concerning patent applications, issued patents, or other proprietary rights; ▪ the recruitment or departure of key personnel; ▪ the level of expenses related to any of our research programs or product candidates that we may develop; ▪ the results of our efforts to develop additional product candidates or products; ▪ actual or anticipated changes in estimates as to financial results, development timelines, or recommendations by securities analysts; ▪ announcement or expectation of additional financing efforts; ▪ sales of our common stock by us, our insiders or other stockholders; ▪ expiration of market stand-off or lock-up agreement; ▪ effects of public health crises, pandemics and epidemics; ▪ variations in our financial results or those of companies that are perceived to be similar to us; ▪ changes in estimates or recommendations by securities analysts, if any, that cover our stock; ▪ changes in the structure of healthcare payment systems; ▪ market conditions in the pharmaceutical and biotechnology sectors; ▪ general economic, industry, and market conditions; and 83 Table of Contents ▪ the other factors described in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K.
Some of the factors that may cause the market price of our common stock to fluctuate include: ▪ the success of existing or new competitive product candidates or technologies; ▪ the timing and results of preclinical studies for any product candidates that we may develop; ▪ failure or discontinuation of any of our product development and research programs; ▪ results of preclinical studies, clinical trials, or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors; ▪ commencement or termination of collaborations for our product development and research programs; ▪ regulatory or legal developments in the United States and other countries; ▪ developments or disputes concerning patent applications, issued patents, or other proprietary rights; ▪ the recruitment or departure of key personnel; ▪ the level of expenses related to any of our research programs or product candidates that we may develop; ▪ the results of our efforts to develop additional product candidates or products; ▪ actual or anticipated changes in estimates as to financial results, development timelines, or recommendations by securities analysts; ▪ announcement or expectation of additional financing efforts; 77 T a b le of Contents ▪ sales of our common stock by us, our insiders or other stockholders; ▪ expiration of market stand-off or lock-up agreement; ▪ effects of public health crises, pandemics and epidemics; ▪ variations in our financial results or those of companies that are perceived to be similar to us; ▪ changes in estimates or recommendations by securities analysts, if any, that cover our stock; ▪ changes in the structure of healthcare payment systems; ▪ market conditions in the pharmaceutical and biotechnology sectors; ▪ general economic, industry, and market conditions; and ▪ the other factors described in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K.
Our directors and executive officers and their affiliates beneficially own shares representing approximately 25% of our outstanding common stock as of March 7, 2025. As a result, these stockholders, if they act together, will be able to influence our management and affairs and all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions.
Our directors and executive officers and their affiliates beneficially own shares representing approximately 25% of our outstanding common stock as of March 6, 2026. As a result, these stockholders, if they act together, will be able to influence our management and affairs and all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards.
If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile. In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards.
If a CMO or third-party supplier fails to acquire the proper licenses or otherwise infringes, misappropriates or otherwise violates the intellectual property or the proprietary rights of others in the course of providing services to us, we may have to find alternative CMOs or third-party suppliers or defend against claims of infringement, either of which would significantly impact our ability to develop, obtain regulatory approval for, or commercialize our product candidates, if approved.
If a CMO or third-party supplier fails to acquire the proper licenses or otherwise infringes, misappropriates or otherwise violates the intellectual property or the proprietary rights of others in the course of providing services to us, we may have to find 60 T a b le of Contents alternative CMOs or third-party suppliers or defend against claims of infringement, either of which would significantly impact our ability to develop, obtain regulatory approval for, or commercialize our product candidates, if approved.
Among other things, the IRA implemented a one percent (1%) excise tax on certain repurchases (including redemptions) of stock by publicly traded domestic corporations, and a corporate alternative minimum tax of 87 Table of Contents fifteen percent (15%) on book income of certain large corporations.
Among other things, the IRA implemented a one percent (1%) excise tax on certain repurchases (including redemptions) of stock by publicly traded domestic corporations, and a corporate alternative minimum tax of fifteen percent (15%) on book income of certain large corporations.
Until such time, if ever, as we generate significant revenue from product sales, we expect to finance our operations through the sale of equity, debt financings, collaborations, strategic alliances and licensing arrangements or other sources. We do not currently have any committed external source of funds.
If we continue to progress the development of our product candidates, until such time, if ever, as we generate significant revenue from product sales, we expect to finance our operations through the sale of equity, debt financings, collaborations, strategic alliances and licensing arrangements or other sources. We do not currently have any committed external source of funds.
We are obligated to make certain payments under our agreements with Affibody, Prophylix, Sobi, and Sanofi, including milestone and royalty payments in connection with achievement of certain development and commercial milestones as well as the sale of resulting products under such agreements.
We are obligated to make certain payments under our agreements with Affibody, Sobi, and Kymab Limited ("Sanofi"), including milestone and royalty payments in connection with achievement of certain development and commercial milestones as well as the sale of resulting products under such agreements.
Intellectual property litigation or other legal proceedings relating to intellectual property could cost substantial resources. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
For example, the loss of preclinical or clinical trial data from completed, ongoing, or planned trials, or the loss of other proprietary data, could result in delays in our 81 Table of Contents regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
For example, the loss of preclinical or clinical trial data from completed, ongoing, or planned trials, or the loss of other proprietary data, could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
These events include, but are not limited to: ▪ the FDA, EMA or other comparable foreign regulatory authorities requiring us to submit additional data or imposing other requirements before permitting us to commence a trial; ▪ delays in receiving or denial by regulatory agencies of permission to proceed with our planned clinical trials or any other clinical trials we may initiate, or placement of a clinical trial on hold; ▪ negative results from our non-clinical trials or clinical trials; ▪ challenges, delays and cost involved in identifying, recruiting and retaining suitable participants and clinical trial sites in sufficient numbers to participate in clinical trials; ▪ delays in reaching an agreement on acceptable terms with prospective contract research organizations ("CROs") and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ▪ delays in obtaining IRB approval at each site within the United States, or Independent Ethics Committee ("IEC") approval at sites outside the United States; ▪ delays or problems in analyzing data, or the need for additional analysis or data or the need to enroll additional patients; ▪ failure by us, our CROs, trial sites or investigators to adhere to clinical trial, regulatory, legal or contractual requirements and perform trials in accordance with the FDA’s GCP requirements and trial protocol; ▪ inadequate quantity or quality of product candidate or other materials necessary to conduct clinical trials, for example as a result of delays in defining and implementing the manufacturing process for materials used in clinical trials or for the manufacture of larger quantities or other delays or issues arising in the manufacturing of sufficient supply of finished drug product; ▪ problems with designing and readiness of in vitro diagnostic devices, including companion diagnostic testing, if required, and our inability, or that of our collaborators, to develop any required laboratory diagnostic tests or companion diagnostics for RLYB212 or any other product candidate; ▪ lack of adequate funding to continue a clinical trial, including as a result of unanticipated costs or increases in costs of clinical trials; ▪ occurrence of serious adverse events including unexpected serious adverse events, associated with the product candidate or reports from non-clinical or clinical testing of our own or competing therapies that raise safety or efficacy concerns, or delays or failures in addressing patient safety concerns that arise during the course of a trial; ▪ changes in regulatory requirements and guidance that require changes to planned or ongoing preclinical and clinical studies, or the conduct of additional studies; and ▪ difficulties recruiting and retaining employees, consultants or contractors with the required level of expertise.
These events include, but are not limited to: ▪ the FDA, EMA or other comparable foreign regulatory authorities requiring us to submit additional data or imposing other requirements before permitting us to commence a trial; ▪ delays in receiving or denial by regulatory agencies of permission to proceed with our planned clinical trials or any other clinical trials we may initiate, or placement of a clinical trial on hold; ▪ negative results from our non-clinical trials or clinical trials; ▪ challenges, delays and cost involved in identifying, recruiting and retaining suitable participants and clinical trial sites in sufficient numbers to participate in clinical trials; ▪ delays in reaching an agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ▪ delays in obtaining an independent IRB approval at each site within the United States, or Independent Ethics Committee ("IEC") approval at sites outside the United States; ▪ delays or problems in analyzing data, or the need for additional analysis or data or the need to enroll additional patients; ▪ failure by us, our CROs, trial sites or investigators to adhere to clinical trial, regulatory, legal or contractual requirements and perform trials in accordance with the FDA’s GCP requirements and trial protocol; ▪ inadequate quantity or quality of product candidate or other materials necessary to conduct clinical trials, for example as a result of delays in defining and implementing the manufacturing process for materials used in clinical trials or for the manufacture of larger quantities or other delays or issues arising in the manufacturing of sufficient supply of finished drug product; ▪ lack of adequate funding to continue a clinical trial, including as a result of unanticipated costs or increases in costs of clinical trials; ▪ occurrence of serious adverse events including unexpected serious adverse events, associated with the product candidate or reports from non-clinical or clinical testing of our own or competing therapies that raise safety or efficacy concerns, or delays or failures in addressing patient safety concerns that arise during the course of a trial; ▪ changes in regulatory requirements and guidance that require changes to planned or ongoing preclinical and clinical studies, or the conduct of additional studies; and ▪ difficulties recruiting and retaining employees, consultants or contractors with the required level of expertise.
As of December 31, 2024, we had an accumulated deficit of $293.0 million. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to gain regulatory approval and become commercially viable.
As of December 31, 2025, we had an accumulated deficit of $302.0 million. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to gain regulatory approval and become commercially viable.
PRIME enables an applicant to request parallel EMA scientific advice and health technology assessment advice to facilitate timely market access. Even if we receive PRIME designation for any of our product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional EMA procedures.
PRIME enables an applicant to request parallel EMA scientific advice and HTA advice to facilitate timely market access. Even if we receive PRIME designation for any of our product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional EMA procedures.
These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and Part D drugs (with negotiated prices for the first set of drugs scheduled to take effect in 2026).
These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and D drugs (with negotiated prices for the first set of drugs taking effect in 2026).
We may experience events that could delay or prevent our ability to complete current clinical trials or initiate and complete new trials, any of which may impact our product development timelines, result in increased costs, affect our ability to obtain marketing approval according to our plans, and delay commercialization of our product candidates.
If we continue to progress the development of our product candidates, we may experience events that could delay or prevent our ability to complete current clinical trials or initiate and complete new trials, any of which may impact our product development timelines, result in increased costs, affect our ability to obtain marketing approval according to our plans, and delay commercialization of our product candidates.
Our product candidates target rare diseases and conditions, and the market opportunities for RLYB212, RLYB116 or any of our other product candidates, if approved, may be smaller than we anticipate. We must be able to successfully identify patients and capture a significant market share to achieve profitability and growth. Our product candidates target rare diseases and conditions.
Our product candidates target rare diseases and conditions, and if we continue to progress the development of our product candidates, the market opportunities for RLYB116 or any of our other product candidates, if approved, may be smaller than we anticipate. We must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
The lack of screening and diagnostic tests, coupled with the fact that there is frequently limited awareness among certain health care providers concerning the rare diseases we may seek to treat, often means that a proper diagnosis can, and frequently does, take years to identify (or an appropriate diagnosis may never be made for certain patients).
The lack of screening and diagnostic tests, coupled with the fact that there is frequently limited awareness among certain health care providers concerning the rare diseases 48 T a b le of Contents we may seek to treat, often means that a proper diagnosis can, and frequently does, take years to identify (or an appropriate diagnosis may never be made for certain patients).
For these reasons, we may not be able to use a material portion of our NOLs or tax credit carryforwards, even if we attain profitability. 45 Table of Contents Risks Related to Discovery, Development, Clinical Testing, Manufacturing, Marketing Approval and Commercialization We are heavily dependent on the success of RLYB212 and RLYB116, which are in early-stage clinical development.
For these reasons, we may not be able to use a material portion of our NOLs or tax credit carryforwards, even if we attain profitability. Risks Related to Discovery, Development, Clinical Testing, Manufacturing, Marketing Approval and Commercialization We are heavily dependent on the success of RLYB116, which is in early-stage clinical development.
Our failure to become and remain profitable would decrease the value of the Company and could impair our ability to raise capital, maintain our research and development efforts, expand our business, execute our business plan or continue our operations. We will require significant additional capital to fund our operations.
Our failure to become and remain profitable would decrease the value of the Company and could impair our ability to raise capital, maintain our research and development efforts, expand our business, execute our business plan or continue our operations. If we continue to progress the development of our product candidates, we will require significant additional capital to fund our operations.
Any of the foregoing could harm our business and we cannot anticipate 88 Table of Contents all of the ways in which current geopolitical tensions, the economic climate and the financial market conditions could adversely impact our business.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which current geopolitical tensions, the economic climate and the financial market conditions could adversely impact our business.
Moreover, uncertain geopolitical events, such as the war in Ukraine and conflict in Israel, have impacted the global economy, and a severe or prolonged economic downturn could result in a variety of challenges for our business, including disruptions in the financial markets, which could adversely impact our ability to raise additional capital when needed or on favorable terms, if at all.
Moreover, uncertain geopolitical events, such as the war in Ukraine and conflict in Israel, and uncertain global economic conditions, including as a result of changes in tariffs and other trade restrictions, have impacted the global economy, and a severe or prolonged economic downturn could result in a variety of challenges for our business, including disruptions in the financial markets, which could adversely impact our ability to raise additional capital when needed or on favorable terms, if at all.
We may seek Fast Track designation, Breakthrough Therapy designation, or PRIME designation for our product candidates, but we might not receive any such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval process.
If we continue to progress the development of our product candidates, we may seek Fast Track designation, Breakthrough Therapy designation, or PRIME designation for our product candidates, but we might not receive any such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval process.
Accordingly, even if we believe that RLYB212 meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.
Accordingly, even if we believe that a product candidate meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.
A severe or prolonged economic downturn, period of sustained increased inflation, or additional global financial crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.
A severe or prolonged economic downturn, period of sustained increased inflation, tariffs and other trade restrictions or additional global financial crises, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all.
Even after we receive and incorporate guidance from these regulatory authorities, the FDA, EMA or other regulatory authorities could (i) disagree that we have satisfied their requirements to commence our clinical trial, (ii) change their position on the acceptability of our data, trial design or the clinical 47 Table of Contents endpoints selected, which may require us to complete additional preclinical studies or clinical trials or (iii) impose stricter requirements for approval than we currently expect.
Even after we receive and incorporate guidance from these regulatory authorities, the FDA, EMA or other regulatory authorities could (i) disagree that we have satisfied their requirements to commence our clinical trial, (ii) change their position on the acceptability of our data, trial design or the clinical 42 T a b le of Contents endpoints selected, which may require us to complete additional preclinical studies or clinical trials or (iii) impose stricter requirements for approval than we currently expect.
Our future capital requirements, both near and long-term, will depend on many factors, including, but not limited to: ▪ the initiation, progress, timing, costs and results of our clinical trials through all phases of development; ▪ the outcome, timing and cost of meeting regulatory requirements established by the FDA, EMA, and other comparable foreign regulatory authorities, including any regulatory designations allowing for 42 Table of Contents priority review and any additional clinical trials required by the FDA, EMA or other comparable foreign regulatory authorities; ▪ the willingness of the FDA, EMA and other comparable foreign regulatory authorities to accept our clinical trial designs, as well as data from our completed and planned preclinical studies and clinical trials, as the basis for review and approval of RLYB212, RLYB116 and any other product candidates; ▪ the cost and timing of the manufacture and supply of non-clinical, clinical and commercial quantities of RLYB212, RLYB116 and our other product candidates; ▪ the progress, timing and costs of the development by us or third parties of companion diagnostics, if required, for RLYB212 or any other product candidates, including design, manufacturing and regulatory approval; ▪ the identification, assessment, acquisition and/or development of additional research programs and additional product candidates; ▪ the cost of filing, prosecuting, and enforcing our patent claims and other intellectual property rights; ▪ the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us; ▪ the costs associated with potential clinical trial liability or product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims; ▪ the effect of competing technological and market developments; ▪ the cost of making royalty, milestone or other payments under our current or any future in-license agreements; ▪ our ability to maintain our collaborations with Recursion (as successor in interest to Exscientia) and AbCellera on favorable terms and establish new collaborations; ▪ the extent to which we in-license or acquire additional product candidates or technologies; and ▪ the costs of operating as a public company.
Our future capital requirements, both near and long-term, will depend on many factors, including, but not limited to: ▪ the initiation, progress, timing, costs and results of our clinical trials through all phases of development; ▪ the outcome, timing and cost of meeting regulatory requirements established by the FDA, EMA, and other comparable foreign regulatory authorities, including any regulatory designations allowing for priority review and any additional clinical trials required by the FDA, EMA or other comparable foreign regulatory authorities; ▪ the willingness of the FDA, EMA and other comparable foreign regulatory authorities to accept our clinical trial designs, as well as data from our completed and planned preclinical studies and clinical trials, as the basis for review and approval of RLYB116 and any other product candidates; 37 T a b le of Contents ▪ the cost and timing of the manufacture and supply of non-clinical, clinical and commercial quantities of RLYB116 and our other product candidates; ▪ the identification, assessment, acquisition and/or development of additional research programs and additional product candidates; ▪ the cost of filing, prosecuting, and enforcing our patent claims and other intellectual property rights; ▪ the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us; ▪ the costs associated with potential clinical trial liability or product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims; ▪ the effect of competing technological and market developments; ▪ the cost of making royalty, milestone or other payments under our current or any future in-license agreements; ▪ our ability to maintain our collaboration with AbCellera on favorable terms and establish new collaborations; ▪ the extent to which we in-license or acquire additional product candidates or technologies; and ▪ the costs of operating as a public company.
The success of our product candidates will depend on several factors, including the following: ▪ successful and timely initiation of preclinical studies, and successful and timely initiation of, enrollment in, and completion of our clinical trials with results that support a finding of safety and effectiveness and an acceptable risk-benefit profile of our product candidates in the intended populations within the timeframes we have projected; ▪ regulatory grants of authorization to proceed under investigational new drug applications or CTAs such that we can commence planned or future clinical trials of our product candidates; ▪ sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ▪ receipt of marketing approvals from applicable regulatory authorities for our product candidates, and if required, in vitro diagnostic devices including companion diagnostics; ▪ our ability to successfully utilize certain delivery systems, such as pre-filled syringes ("PFSs"), pen-injectors and/or autoinjectors, for certain of our product candidates and to obtain marketing approval of any such drug/device combination product; ▪ the outcome, timing, and cost of meeting regulatory requirements, including any post-marketing commitments, established by the FDA, EMA and other comparable foreign regulatory authorities; ▪ establishing commercially viable arrangements with third-party manufacturers for clinical and commercial supply; 46 Table of Contents ▪ obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; ▪ establishing sales, marketing and distribution capabilities, whether alone or through a collaboration, to support commercialization of our product candidates, if and when approved; ▪ acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; ▪ effectively differentiating and competing with other therapies approved and/or used for the same indications as our product candidates, particularly RLYB116; ▪ obtaining and maintaining third-party coverage and reimbursement; ▪ enforcing and defending intellectual property rights and claims; and ▪ maintaining an acceptable safety profile of the product candidates following approval.
If we continue to progress the development of our product candidates, the success of our product candidates will depend on several factors, including the following: ▪ successful and timely initiation of preclinical studies, and successful and timely initiation of, enrollment in, and completion of our clinical trials with results that support a finding of safety and effectiveness and an acceptable risk-benefit profile of our product candidates in the intended populations within the timeframes we have projected; ▪ regulatory grants of authorization to proceed under investigational new drug applications or CTAs such that we can commence planned or future clinical trials of our product candidates; ▪ sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ▪ our ability to successfully utilize certain delivery systems, such as pre-filled syringes ("PFSs"), pen-injectors and/or autoinjectors, for certain of our product candidates and to obtain marketing approval of any such drug/device combination product; ▪ the outcome, timing, and cost of meeting regulatory requirements, including any post-marketing commitments, established by the FDA, EMA and other comparable foreign regulatory authorities; ▪ establishing commercially viable arrangements with third-party manufacturers for clinical and commercial supply; ▪ obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; ▪ establishing sales, marketing and distribution capabilities, whether alone or through a collaboration, to support commercialization of our product candidates, if and when approved; 41 T a b le of Contents ▪ acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; ▪ effectively differentiating and competing with other therapies approved and/or used for the same indications as our product candidates, particularly RLYB116; ▪ obtaining and maintaining third-party coverage and reimbursement; ▪ enforcing and defending intellectual property rights and claims; and ▪ maintaining an acceptable safety profile of the product candidates following approval.
On June 4, 2021, the European Commission released two revised sets of standard contractual clauses for transfers of personal data from the EEA to the U.S. and has indicated that it will release additional revised standard contractual clauses in the near future.
On June 4, 2021, the EC released two revised sets of standard contractual clauses for transfers of personal data from the EEA to the U.S. and has indicated that it will release additional revised standard contractual clauses in the future.
Such authorities may impose a suspension or termination or recommend an alteration to clinical trials due to several factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, 48 Table of Contents the identification of safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions.
Such authorities may impose a suspension or termination or recommend an alteration to clinical trials due to several factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, 43 T a b le of Contents the identification of safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions.
We may be subject to fines and other penalties if we fail to report such prices accurately. 60 Table of Contents No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States.
We may be subject to fines and other penalties if we fail to report such prices accurately. No uniform policy for coverage and reimbursement for products exists among third-party payors in the United States.
Similarly, in the EU, the market exclusivity can be broken if the holder of the marketing authorization for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product.
Similarly, in the EU, the market exclusivity can be broken if the holder of the MA for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product.
Risks Related to Our Dependence on Third Parties We may pursue business development transactions and collaborate with third parties for the development and commercialization of our product candidates.
Risks Related to Our Dependence on Third Parties If we continue to progress the development of our product candidates, we may pursue business development transactions and collaborate with third parties for the development and commercialization of our product candidates.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours during periods when commercial exclusivity would be valuable to us. If we do not obtain a patent term extension for any product candidates we might develop, our business might be materially harmed.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours during periods when commercial exclusivity would be valuable to us. 70 T a b le of Contents If we do not obtain a patent term extension for any product candidates we might develop, our business might be materially harmed.
Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects. Risks Related to Our Employees, Managing Our Growth and Our Operations Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects. 74 T a b le of Contents Risks Related to Our Employees, Managing Our Growth and Our Operations Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
If we continue to progress the development of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
If we obtain FDA approval for RLYB212 or RLYB116, safety risks not identified in our prior clinical trials may first appear after we obtain approval and commercialize these product candidates. Any new post-marketing adverse events may significantly impact our ability to market the drugs and may require that we recall and discontinue commercialization of the products.
If we obtain FDA approval for RLYB116, safety risks not identified in our prior clinical trials may first appear after we obtain approval and commercialize RLYB116. Any new post-marketing adverse events may significantly impact our ability to market the drugs and may require that we recall and discontinue commercialization of RLYB116.
Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.
Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost 62 T a b le of Contents disclosure and transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.
Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing 71 Table of Contents interpretation.
Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. We expect to incur significant additional operating losses in the foreseeable future as we advance our programs and operate our business.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. If we continue to progress the development of our product candidates, we expect to incur significant additional operating losses in the foreseeable future as we advance our programs and operate our business.
Enrollment and retention of patients in rare disease clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control. Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success.
Enrollment and retention of patients in rare disease clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control. If we continue to progress the development of our product candidates, identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success.

… 324 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed6 unchanged
Biggest changeOur cybersecurity risk management program includes: • Risk assessments designed to help identify material cybersecurity risks to our critical systems, information, product candidates and our broader enterprise information technology ("IT") environment. 89 Table of Contents • A team principally responsible for managing: (a) our cybersecurity risk assessment processes, (b) our security controls, and (c) our response to cybersecurity incidents. • The use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security controls as part of our operational security model. • Threat intelligence that informs our third party IT service provider and us about new vulnerabilities and risks that require timely intervention or remediation. • Cybersecurity awareness training of our employees, incident response personnel, and senior management. • A cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents.
Biggest changeOur cybersecurity risk management program includes: • Risk assessments designed to help identify material cybersecurity risks to our critical systems, information, product candidates and our broader enterprise information technology ("IT") environment. • A team principally responsible for managing: (a) our cybersecurity risk assessment processes, (b) our security controls, and (c) our response to cybersecurity incidents. • The use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security controls as part of our operational security model. • Threat intelligence that informs our third party IT service provider and us about new vulnerabilities and risks that require timely intervention or remediation. • Cybersecurity awareness training of our employees, incident response personnel, and senior management. • A cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−0 removed1 unchanged
Biggest changeItem 2. Properties. Our corporate headquarters is located at 234 Church Street, Suite 1020, New Haven, CT 06510, where we lease and occupy 9,000 square feet of office space. The current term of our lease in New Haven expires September 30, 2025. We believe that this office space is sufficient to meet our current needs.
Biggest changeItem 2. Properties. Our corporate headquarters is located at 234 Church Street, New Haven, CT 06510, where we lease and occupy 4,500 square feet of office space. The current term of our lease in New Haven expires September 30, 84 T a b le of Contents 2027. We believe that this office space is sufficient to meet our current needs.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

6 edited+0 added−9 removed5 unchanged
Biggest changeThis figure does not include 21,950 outstanding restricted stock awards that were issued under the 2021 Equity Incentive Plan. (2) The weighted-average exercise price is calculated based on the exercise prices of outstanding options and does not include outstanding restricted stock units (which have no exercise price).
Biggest change(2) The weighted-average exercise price is calculated based on the exercise prices of outstanding options and does not include outstanding restricted stock units (which have no exercise price). (3) Includes 590,690 shares available for future issuance under the 2021 Equity Incentive Plan and 94,281 shares available for future issuance under the 2021 Employee Stock Purchase Plan.
Any future determination related to our dividend policy will be made at the discretion of our 90 Table of Contents board of directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors our board of directors deems relevant, and subject to the restrictions contained in any future financing instruments.
Any future determination related to our dividend policy will be made at the discretion of our board of directors after considering our financial condition, results of operations, capital requirements, business prospects and other factors our board of directors deems relevant, and subject to the restrictions contained in any future financing instruments.
In addition, the number of shares reserved for issuance under the 2021 Equity Incentive Plan automatically increases on January 1st of each year from 2022 to 2031 by the lesser of (i) five percent of the number of shares of the Company's common stock outstanding as of such date and (ii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date.
In addition, the number of shares 85 T a b le of Contents reserved for issuance under the 2021 Equity Incentive Plan automatically increases on January 1st of each year from 2022 to 2031 by the lesser of (i) five percent of the number of shares of the Company's common stock outstanding as of such date and (ii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date.
The number of shares reserved for issuance under the 2021 Employee Stock Purchase Plan automatically increases on January 1st of each year from 2022 to 2031 by the lesser of (i) one percent of the number of shares of the Company's common stock outstanding as of such date (ii) 582,648 shares of the Company's common stock, and (iii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date (up to a maximum of 6,117,804 in the aggregate).
The number of shares reserved for issuance under the 2021 Employee Stock Purchase Plan automatically increases on January 1st of each year from 2022 to 2031 by the lesser of (i) one percent of the number of shares of the Company's common stock outstanding as of such date (ii) 72,831 shares of the Company's common stock, and (iii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date (up to a maximum of 764,725 in the aggregate).
Securities Authorized for Issuance Under Equity Compensation Plans The information provided in the following table is as of December 31, 2024: Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights and outstanding nonvested restricted stock units (1) Weighted-average exercise price of outstanding options, warrants and rights (2) Number of securities remaining available for future issuance under equity compensation plans (3) Equity compensation plans approved by security holders 5,299,924 $ 7.85 4,195,223 Equity compensation plans not approved by security holders — — — (1) Reflects 4,235,183 shares of common stock to be issued upon exercise of outstanding options under our 2021 Equity Incentive Plan and 1,064,741 outstanding restricted stock units that were issued under the 2021 Equity Incentive Plan.
Securities Authorized for Issuance Under Equity Compensation Plans The information provided in the following table is as of December 31, 2025: Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights and outstanding nonvested restricted stock units (1) Weighted-average exercise price of outstanding options, warrants and rights (2) Number of securities remaining available for future issuance under equity compensation plans (3) Equity compensation plans approved by security holders 666,883 $ 43.42 684,971 Equity compensation plans not approved by security holders — — — (1) Reflects 628,280 shares of common stock to be issued upon exercise of outstanding options under our 2021 Equity Incentive Plan and 38,603 outstanding restricted stock units that were issued under the 2021 Equity Incentive Plan.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock began trade on the Nasdaq Global Select Market under the symbol “RLYB.” Trading of our common stock commenced on July 29, 2021 in connection with our IPO.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on the Nasdaq Capital Market under the symbol “RLYB.” Stockholders As of December 31, 2025, there were 12 holders of record of our common stock.
Removed
Prior to that time, there was no established public trading market for our common stock. Stockholders As of December 31, 2024, there were 13 holders of record of our common stock.
Removed
(3) Includes 3,383,211 shares available for future issuance under the 2021 Equity Incentive Plan and 812,012 shares available for future issuance under the 2021 Employee Stock Purchase Plan.
Removed
Use of Proceeds from Registered Securities In August, 2021, we completed the IPO of our common stock pursuant to which we issued and sold 7,130,000 shares of our common stock, inclusive of 930,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $13.00 per share.
Removed
The aggregate offering price of our IPO was $92.7 million.
Removed
The offer and sale of all of the shares of our common stock in our IPO were registered under the Securities Act pursuant to a registration statement on Form S-1, as amended (File No. 333-257655), which was declared effective by the SEC on July 28, 2021 and a registration statement on Form S-1MEF (File No. 333-258244), which was automatically effective upon filing with the SEC on July 28, 2021.
Removed
Following the sale of all of the shares offered in connection with the closing of our IPO, the offering terminated. Jefferies LLC, Cowen and Company, LLC and Evercore Group L.L.C. acted as co-managers for the offering.
Removed
We received aggregate gross proceeds from our IPO of $92.7 million, or aggregate net proceeds of $83.0 million after deducting underwriting discounts and commissions and other offering costs.
Removed
None of the underwriting discounts and commissions or offering costs were incurred or paid, directly or indirectly, to directors or officers of ours or their associates or to persons owning 10% or more of our common stock or to any of our affiliates.
Removed
We intend to use any remaining proceeds from our IPO primarily to support the development of our pipeline programs, working capital needs and general corporate purposes. Item 6. Reserved 91 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

68 edited+37 added−52 removed39 unchanged
Biggest changeThe decrease of $12.0 million was primarily due to: ▪ a $4.4 million decrease in costs related to the development of RLYB212, primarily attributable to a decrease in manufacturing and other related development costs; which were partially offset by an increase in clinical costs; ▪ a $4.0 million decrease in costs related to the development of RLYB116, primarily attributable to a decrease in clinical and other related development costs; which were partially offset by an increase in manufacturing costs; ▪ a $1.7 million decrease in payroll and personnel-related expenses, primarily related to the workforce reduction, effective March 6, 2024; and ▪ a $1.5 million decrease in costs related to the development of other program candidates.
Biggest changeThe decrease of $21.9 million was primarily due to: ▪ a $15.0 million decrease in costs related to the development of RLYB212, primarily related to a decrease in clinical development costs, manufacturing costs and other related development costs as a result of our discontinuation of the FNAIT program in April 2025; ▪ a $1.1 million decrease in costs related to the development of RLYB116, primarily related to a decrease in manufacturing costs; which were partially offset by an increase in clinical development costs and other related development costs; 91 T a b le of Contents ▪ a $1.9 million decrease in costs related to the development of other program candidates, primarily related to RLYB332 manufacturing costs and other related development costs; and ▪ a $3.7 million decrease in payroll and personnel-related expenses, primarily due to lower ongoing headcount during the year ended December 31, 2025 as compared to the same period in 2024; offset by an increase in personnel-related expenses due to the severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025.
(2) Dissemination of J&J materials & participant revenue – derived from Rallybio’s dissemination of content, information or materials that are developed by J&J and related to the J&J-Sponsored Studies and are provided by Rallybio to staff at Rallybio study sites for the purpose of disseminating such content, information, or materials to provide to potential eligible participants regarding J&J’s independent study.
(2) Dissemination of J&J materials & participant revenue – derived from Rallybio’s dissemination of content, information or materials related to the J&J-Sponsored Studies that are developed by J&J and are provided by Rallybio for the purpose of disseminating such content, information, or materials to staff at Rallybio study sites to provide to potential eligible participants regarding J&J’s independent study.
The JJDC Securities Purchase Agreement contains provisions related to the registration of the shares and the restriction on the sale or transfer of the shares for a period of time. We determined the J&J Collaboration Agreement and the JJDC Securities Purchase Agreement represented combined agreements.
The JJDC Securities Purchase Agreement contains provisions related to the registration of the shares and the restriction on the sale or transfer of the shares for a period of time. We determined the J&J Collaboration Agreement and JJDC Securities Purchase Agreement represented combined agreements.
We received net proceeds of approximately $83.0 million, after deducting underwriting discounts and commissions and other offering costs.
We received net proceeds of approximately $83.0 million, after deducting underwriting discounts and commissions and other offering costs.
Our collaboration and license revenue generated to date is related to data collection and data submission performance obligations pursuant to the two-year J&J Collaboration Agreement to facilitate the advancement of research into products to address unmet needs relating to FNAIT.
Our collaboration and license revenue to date is related to data collection and data submission performance obligations pursuant to the two-year J&J Collaboration Agreement to facilitate the advancement of research into products to address unmet needs relating to FNAIT.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and footnote disclosures is disclosed in Note 2 “Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation” to our consolidated financial statements for the year ended December 31, 2024 appearing elsewhere in this Annual Report on Form 10-K.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations and footnote disclosures is disclosed in Note 2 “Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation” to our consolidated financial statements for the year ended December 31, 2025 appearing elsewhere in this Annual Report on Form 10-K.
Other exemptions and reduced reporting requirements under the JOBS Act, for EGCs include presentation of only two years of audited financial statements in a registration statement for an initial public offering, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements.
Other exemptions and reduced reporting requirements under the JOBS Act, for EGCs include presentation of only two years of audited financial statements in a registration statement for an IPO, an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements.
We determined there were performance obligations as follows: (1) Data collection & submission revenue – derived from Rallybio’s ongoing management of our studies including the maintenance of a minimum site footprint, the license to utilize, and timely, semi-annual submission of the anonymized data, in the required formats to J&J.
We determined there were performance obligations as follows: (1) Data collection and submission revenue – derived from Rallybio’s ongoing management of the studies including the maintenance of a minimum site footprint, the license to utilize, and timely, semi-annual submission of the anonymized data, in the required formats.
In accordance with the Accounting Standards Codification Topic 606, Revenue from Contracts with Customers and the Accounting Standards Codification Topic 820, Fair Value Measurement , total consideration of $1.2 million for the shares of common stock from the JJDC Securities Purchase Agreement, which represents the premium of $0.7 million and discount for lack of marketability of $0.5 million, has been allocated to revenue and will be recognized over the two year expected performance period.
In accordance with Accounting Standards Codification 606, Revenue Recognition and Accounting Standards Codification Topic 820, Fair Value Measurement , total consideration of $1.2 million for the shares of common stock from the JJDC Securities Purchase Agreement, which represents the premium of $0.7 million and discount for lack of marketability of $0.5 million, has been allocated to revenue and will be recognized over the two year expected performance period.
Emerging Growth Company and Smaller Reporting Company As an emerging growth company (an “EGC”) under the JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies.
Emerging Growth Company and Smaller Reporting Company As an EGC under the JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies.
We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. 102 Table of Contents We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf.
We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. Since our inception, we have funded our operations primarily through equity financings. From our inception and prior to our IPO, we received proceeds of approximately $182.5 million from equity financings.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. Since our inception, we have funded our operations primarily through equity financings. From our inception and prior to our initial public offering ("IPO"), we received proceeds of approximately $182.5 million from equity financings.
Our direct, external research and development expenses consist primarily of fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our process development, manufacturing and clinical development activities. Our direct external research and development expenses also include fees 96 Table of Contents incurred under license and intellectual property purchase agreements.
Our direct, external research and development expenses consist primarily of fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our process development, manufacturing and clinical development activities. Our direct external research and development expenses also include fees incurred under license and intellectual property purchase agreements.
We expense research and development costs as incurred, which include: ▪ external research and development expenses incurred under agreements with third parties, such as CROs as well as investigative sites and consultants that conduct our clinical trials and other scientific development services; ▪ costs related to manufacturing material for our clinical trials, including expenses related to the manufacturing scale-up and fees paid to CMOs; ▪ employee-related expenses, including salaries, bonuses, benefits, share-based compensation and other related costs for those employees involved in research and development efforts; ▪ costs of outside consultants, including their fees, and related travel expenses; ▪ expenses to acquire technologies, such as intellectual property, to be used in research and development including in-process research and development ("IPR&D") that has no alternative future use at the time of asset acquisitions; ▪ costs related to compliance with quality and regulatory requirements; and ▪ facilities, depreciation and other indirect costs allocated to employees and activities supporting our research and development efforts.
We expense research and development costs as incurred, which include: ▪ external research and development expenses incurred under agreements with third parties, such as contract research organizations ("CROs") as well as investigative sites and consultants that conduct our clinical trials and other scientific development services; ▪ costs related to manufacturing material for our clinical trials, including expenses related to the manufacturing scale-up and fees paid to contract manufacturing organizations ("CMOs"); 89 T a b le of Contents ▪ employee-related expenses, including salaries, bonuses, benefits, share-based compensation and other related costs for those employees involved in research and development efforts; ▪ costs of outside consultants, including their fees, and related travel expenses; ▪ expenses to acquire technologies, such as intellectual property, to be used in research and development including in-process research and development ("IPR&D") that has no alternative future use at the time of asset acquisitions; ▪ costs related to compliance with quality and regulatory requirements; and ▪ facilities, depreciation and other indirect costs allocated to employees and activities supporting our research and development efforts.
Contractual Obligations The following table summarizes our contractual obligations as of December 31, 2024: PAYMENTS DUE BY PERIOD (in thousands) TOTAL LESS THAN 1 YEAR 1-3 YEARS 3-5 YEARS MORE THAN 5 YEARS Operating lease obligations $ 156 $ 156 $ — $ — $ — The contractual obligation amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions and the approximate timing of the actions under the contracts.
Contractual Obligations The following table summarizes our contractual obligations as of December 31, 2025: PAYMENTS DUE BY PERIOD (in thousands) TOTAL LESS THAN 1 YEAR 1-3 YEARS 3-5 YEARS MORE THAN 5 YEARS Operating lease obligations $ 190 $ 106 $ 84 $ — $ — The contractual obligation amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions and the approximate timing of the actions under the contracts.
We use internal resources and third-party consultants primarily to conduct our research and development activities as well as for managing our process development, manufacturing and clinical development activities. The successful development of our product candidates is highly uncertain.
We use internal resources and third-party consultants primarily to conduct our research and development activities as well as for managing our process development, manufacturing and clinical development activities. The successful development of any product candidate is highly uncertain.
Share-Based Compensation The Company accounts for share-based compensation in accordance with the Accounting Standards Codification 718, Compensation—Stock Compensation . Generally, share-based compensation is measured at the grant date for all equity-based awards made to employees based on the fair value of the awards and is recognized over the requisite service period, which is generally the vesting period.
Share-Based Compensation We account for share-based compensation in accordance with the Accounting Standards Codification 718, Compensation—Stock Compensation . Generally, share-based compensation is measured at the grant date for all equity-based awards made to employees based on the fair value of the awards and is recognized over the requisite service period, which is generally the vesting period.
Share-based compensation for awards with performance conditions are recognized over the service period when achievement of the performance condition is probable. The Company has elected to recognize the actual forfeitures by reducing the share-based compensation in the same period as the forfeitures occur.
Share-based compensation for awards with performance conditions are recognized over the service period when achievement of the performance condition is probable. We have elected to recognize the actual forfeitures by reducing the share-based compensation in the same period as the forfeitures occur.
We track these external research and development costs on a program-by-program basis. We do not allocate employee costs, costs associated with our facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified.
We track these external research and development costs on a program-by-program basis. We do not allocate employee costs, facility costs, including depreciation, or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, intellectual property, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, 93 T a b le of Contents intellectual property, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
We may incur contingent payments upon our achievement of clinical, regulatory and commercial milestones, as applicable under agreements we have entered into with various third-party entities pursuant to which we have acquired or in-licensed intellectual property.
We may incur contingent payments upon our achievement of clinical, regulatory and commercial milestones, as applicable under agreements we have entered into with various third-party entities pursuant to which we have 94 T a b le of Contents acquired or in-licensed intellectual property.
See “Business—License Agreements” and “Business—Asset Purchase Agreements” included elsewhere in this Annual Report on Form 10-K for a description of these agreements. Critical Accounting Policies and Significant Judgments and Estimates Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP").
See “Business—License Agreements” and “Business—Asset Purchase Agreements” included elsewhere in this Annual Report on Form 10-K for a description of these agreements. Critical Accounting Estimates Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America.
Under the Sales Agreement, Cowen will be entitled to compensation equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of December 31, 2024, the Company had not sold any shares of common stock pursuant to the Sales Agreement.
Under the Sales Agreement, TD Cowen will be entitled to compensation equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of December 31, 2025, we had not sold any shares of common stock pursuant to the Sales Agreement.
This multi-year, multi-target collaboration will combine AbCellera’s antibody discovery engine with our clinical and commercial expertise in rare diseases to identify optimal clinical candidates with a goal of delivering therapies to patients.
This multi-year, multi-target collaboration combined AbCellera Biologics Inc.'s ("AbCellera's") antibody discovery engine with our clinical and commercial expertise in rare diseases to identify optimal clinical candidates with a goal of delivering therapies to patients.
Under the terms of the JJDC Securities Purchase Agreement, JJDC made an equity investment purchasing 3,636,363 shares of common stock with a par value of $0.0001 per share for a share purchase price of $1.82 per share which includes a 10% premium for an aggregate purchase price of $6.6 million.
Under the terms of the JJDC Securities Purchase Agreement, JJDC made an equity investment purchasing 454,545 shares of common stock with a par value of $0.0001 per share for a share purchase price of $14.56 per share which includes a 10% premium for an aggregate purchase price of $6.6 million.
In August 2021, we closed our IPO and issued and sold 7,130,000 shares of common stock, inclusive of 930,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $13.00 per share.
In August 2021, we closed our IPO and issued and sold 891,250 shares of common stock, inclusive of 116,250 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $104.00 per share.
In August 2021, we closed our IPO and issued and sold 7,130,000 shares of common stock, inclusive of 930,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $13.00 per share.
In August 2021, we closed our IPO and issued and sold 891,250 shares of common stock, inclusive of 116,250 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $104.00 per share.
In April 2024, we entered into the a securities purchase agreement with JJDC (the "JJDC Securities Purchase Agreement") pursuant to which we sold to JJDC, in an unregistered offering, 3,636,363 shares of our common stock at a price of $1.82 per share, which represents a 10% premium on the Company’s closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses.
In April 2024, we entered into the JJDC Securities Purchase Agreement, pursuant to which we sold to JJDC in an unregistered offering, 454,545 shares of our common stock at a price of $14.56 per share, which represented a 10% premium on our closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses.
General and Administrative Expenses General and administrative expenses were $19.6 million for the year ended December 31, 2024, compared to $25.4 million for the year ended December 31, 2023.
General and Administrative Expenses General and administrative expenses were $14.3 million for the year ended December 31, 2025, compared to $19.6 million for the year ended December 31, 2024.
In November 2022, we completed a follow-on offering of approximately $54.8 million pursuant to which we issued 5,803,655 shares of common stock, inclusive of 803,654 shares of common stock sold pursuant to the partial exercise of the underwriters' option to purchase additional shares at a price of $6.00 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 3,333,388 shares of common stock at a price of $5.9999, which represents the per share public offering price for the shares less the $0.0001 per share exercise price for each pre-funded warrant.
In November 2022, we completed a follow-on offering of approximately $54.8 million pursuant to which we issued 725,456 shares of common stock, inclusive of 100,456 shares of common stock sold pursuant to the partial exercise of the underwriters' option to purchase additional shares at a price of $48.00 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 416,673 shares of common stock at a price of $47.9992, which represents the per share public offering price for the shares less the $0.0008 per share exercise price for each pre-funded warrant.
Until such time, if ever, as we generate significant revenue from product sales, we expect to finance our operations through the sale of equity, debt financings, marketing and distribution arrangements and collaborations, strategic alliances and licensing arrangements or other sources. We currently have no credit facility or committed sources of capital.
If we do not complete the proposed transaction with Candid and until such time, if ever, as we generate significant revenue from product sales, we expect to finance our operations through the sale of equity, debt financings, marketing and distribution arrangements and collaborations, strategic alliances and licensing arrangements or other sources.
Cash Flows The following table summarizes our cash flows for each of the periods presented: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2024 2023 Net cash used in operating activities $ (49,282) $ (60,265) Net cash provided by investing activities 33,492 27,658 Net cash provided by financing activities 5,199 143 Net decrease in cash and cash equivalents $ (10,591) $ (32,464) Operating Activities During the year ended December 31, 2024, net cash used in operating activities was $49.3 million as compared to $60.3 million for the year ended December 31, 2023.
Cash Flows The following table summarizes our cash flows for each of the periods presented: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2025 2024 Net cash used in operating activities $ (29,813) $ (49,282) Net cash provided by investing activities 47,268 33,492 Net cash provided by financing activities 16 5,199 Net increase (decrease) in cash and cash equivalents $ 17,471 $ (10,591) Operating Activities During the year ended December 31, 2025, net cash used in operating activities was $29.8 million as compared to $49.3 million for the year ended December 31, 2024.
We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares within 120 days following the closing of the offering. We filed this registration statement on May 10, 2024. As of December 31, 2024, we had $65.5 million of cash, cash equivalents and marketable securities.
We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares within 120 days following the closing of the offering. We filed this registration statement on May 10, 2024.
In November 2022, we completed a follow-on offering of approximately $54.8 million consisting of 5,803,655 shares of common stock, inclusive of 803,654 shares of common stock sold pursuant to the partial exercise of the underwriters' option to purchase additional shares at the price of $6.00 per share, and to certain investors in 99 Table of Contents lieu of common stock, pre-funded warrants to purchase up to an aggregate of 3,333,388 shares of common stock at a price of $5.9999, which represents the per share public offering price for the shares less the $0.0001 per share exercise price for each pre-funded warrant.
In November 2022, we completed a follow-on offering of approximately $54.8 million consisting of 725,456 shares of common stock, inclusive of 100,456 shares of common stock sold pursuant to the partial exercise of the underwriters' option to purchase additional shares at the price of $48.00 per share, and to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 416,673 shares of common stock at a price of $47.9992, which represents the per share public offering price for the shares less the $0.0008 per share exercise price for each pre-funded warrant.
The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis. In 2024, we re-engineered RLYB331 to extend its half-life and completed non-clinical studies that demonstrated favorable tolerability, dose-dependent PK, and sustained PD effects with RLYB332, a long-acting version of RLYB331.
In 2024, we re-engineered RLYB331 to extend its half-life and completed non-clinical studies that demonstrated favorable tolerability, dose-dependent PK, and sustained PD effects with RLYB332, a long-acting version of RLYB331.
The Company also simultaneously entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen"). In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $100.0 million from time to time at prices through Cowen acting as our agent.
In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to 92 T a b le of Contents $9.55 million from time to time at prices through TD Cowen acting as our agent.
There was no collaboration and license revenue for the year ended December 31, 2023. The increase of $0.6 million in 2024 as compared to 2023 was due to our entrance into the J&J Collaboration Agreement in the second quarter of 2024 and the recognition of revenue related to the collaboration performance obligations.
The increase of $0.2 million in 2025 as compared to 2024 was due to our entrance into the J&J Collaboration Agreement in the second quarter of 2024 and the recognition of revenue related to the collaboration performance obligations.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. 103 Table of Contents Off-Balance Sheet Arrangements As of December 31, 2024 and 2023, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
In April 2024, we entered into a Securities Purchase Agreement with JJDC, pursuant to which we sold to JJDC in an unregistered offering, 3,636,363 shares of our common stock at a price of $1.82 per share, which represents a 10% premium on the Company’s closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses.
("JJDC"), pursuant to which we sold to JJDC, in an unregistered offering, 454,545 shares of our common stock at a price of $14.56 per share, which represented a 10% premium on our closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses.
We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2026.
We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, although we anticipate that the proposed merger with Candid will be completed in 2026.
Operating Expenses Research and Development Expenses The following table summarizes our research and development costs for each of the periods presented: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2024 2023 CHANGE Direct research and development by program RLYB212 $ 21,287 $ 25,685 $ (4,398) RLYB116 4,841 8,791 (3,950) Other program candidates 1,901 3,411 (1,510) Other unallocated research and development costs Personnel expenses (including share-based compensation) 12,488 14,160 (1,672) Other expenses 990 1,497 (507) Total research and development expenses $ 41,507 $ 53,544 $ (12,037) 98 Table of Contents Research and development expenses were $41.5 million for the year ended December 31, 2024, compared to $53.5 million for the year ended December 31, 2023.
Operating Expenses Research and Development Expenses The following table summarizes our research and development costs for each of the periods presented: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2025 2024 CHANGE Direct research and development by program RLYB212 $ 6,291 $ 21,287 $ (14,996) RLYB116 3,786 4,841 (1,055) Other program candidates (29) 1,901 (1,930) Other unallocated research and development costs Personnel expenses (including share-based compensation) 8,798 12,488 (3,690) Other expenses 751 990 (239) Total research and development expenses $ 19,597 $ 41,507 $ (21,910) Research and development expenses were $19.6 million for the year ended December 31, 2025, compared to $41.5 million for the year ended December 31, 2024.
Total Other Income, Net Total other income, net, includes interest income earned on cash, cash equivalents and marketable securities, and income and expense items. 97 Table of Contents Loss on Investment in Joint Venture The Company recognizes its pro-rata share of losses in the joint venture with Recursion (as successor in interest to Exscientia) on its consolidated statements of operations and comprehensive loss within the loss on investment in joint venture line item, with a corresponding change to the joint venture investment asset on the consolidated balance sheets for equity method investments for which it does not have a controlling interest in.
Loss on Investment in Joint Venture We recognize the pro-rata share of losses in the joint venture with Recursion (as successor in interest to Exscientia) on the consolidated statements of operations and comprehensive loss within the loss on investment in joint venture line item, with a corresponding change to the joint venture investment asset on the consolidated balance sheets for equity method investments for which we do not have a controlling interest in.
The increase of $5.8 million in net cash provided by investing activities was primarily related to proceeds of $84.4 million from maturities of highly-rated debt securities, partially offset by purchases of highly-rated debt securities of $48.9 million during the year ended December 31, 2024, as compared to proceeds from maturities of highly-rated debt securities of $138.3 million, partially offset by purchases of highly-rated debt securities of $108.4 million during the year ended December 31, 2023. 101 Table of Contents Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was $5.2 million, representing proceeds from the issuance of common stock pursuant to the JJDC Securities Purchase Agreement, after deducting offering costs and accounting for the total consideration allocation related to the J&J Collaboration Agreement of $1.2 million.
Net cash provided by financing activities for the year ended December 31, 2024 was $5.2 million, primarily representing proceeds from the issuance of common stock pursuant to the JJDC Securities Purchase Agreement, after deducting offering costs and accounting for the total consideration allocation related to the J&J Collaboration Agreement of $1.2 million.
RLYB116 is a novel, potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. RLYB114 is a pegylated C5 inhibitor in development for complement-mediated ophthalmic disorders. We have completed a Phase 1 clinical study in healthy participants that included the study of RLYB116 as a SAD and a MAD.
Complement Dysregulation RLYB116 is an innovative, once-weekly, small volume, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. We have completed two Phase 1 clinical trials in healthy participants that included the study of RLYB116 as both a SAD and a MAD.
These findings, which were presented in a poster at the 66th annual meeting of ASH, support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload.
These findings, which were presented in a poster at the 66th annual meeting of ASH, support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload. In December 2022, we entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.
See “—Liquidity and Capital Resources.” We have incurred significant operating losses since inception, including net losses of $57.8 million and $74.6 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $293.0 million.
See “—Liquidity and Capital Resources.” 88 T a b le of Contents We have incurred significant operating losses since inception, including net losses of $9.0 million and $57.8 million for the years ended December 31, 2025 and 2024, respectively.
Loss on Investment in Joint Venture Loss on investment in joint venture for the year ended December 31, 2024 was $2.2 million compared to $2.0 million for the year ended December 31, 2023. The increase in loss on investment in joint venture of $0.2 million was primarily due to an increase in REVI development costs.
Loss on Investment in Joint Venture Loss on investment in joint venture for the year ended December 31, 2025 was $0.9 million compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to the sale of our interest in REV102 in July 2025.
We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares, which we filed on May 10, 2024. 94 Table of Contents As of December 31, 2024, we had cash, cash equivalents and marketable securities of $65.5 million.
We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares, which we filed on May 10, 2024.
The net proceeds from the November 2022 follow-on offering were approximately $50.8 million, after deducting underwriting discounts and commissions and other offering costs.
The net proceeds from the November 2022 follow-on offering were approximately $50.8 million, after deducting underwriting discounts and commissions and other offering costs. In April 2024, we entered into a securities purchase agreement (the "JJDC Securities Purchase Agreement") with Johnson & Johnson Innovation – JJDC, Inc.
The Black-Scholes option-pricing model uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our common stock options, the risk-free interest rate for a period that approximates the expected term of our common stock options, and our expected dividend yield.
We classify share-based compensation in the consolidated statements of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified. 95 T a b le of Contents The Black-Scholes option-pricing model uses as inputs the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our common stock options, the risk-free interest rate for a period that approximates the expected term of our common stock options, and our expected dividend yield.
Pursuant to the J&J Collaboration Agreement, we received an upfront payment of $0.5 million from J&J for the information dissemination and data provision services under the agreement. In addition, we are eligible for payments upon the achievement of certain 95 Table of Contents enrollment-related events, totaling up to $0.7 million.
Pursuant to the J&J Collaboration Agreement, we received an upfront payment of $0.5 million from J&J for the information dissemination and data provision services under the agreement.
Any future sales of equity will result in dilution to our existing stockholders.
We currently have no credit facility or committed sources of capital. Any future sales of equity will result in dilution to our existing stockholders.
The decrease in net cash used in operating activities was primarily related to a decrease in research and development and general and administrative activities and changes in working capital.
The decrease in net cash used in operating activities was primarily related to a decrease in research and development and general and administrative activities and changes in working capital. Investing Activities Net cash provided by investing activities was $47.3 million for the year ended December 31, 2025 as compared to $33.5 million for the year ended December 31, 2024.
General and Administrative Expenses General and administrative expenses consist primarily of salaries, benefits and share-based compensation for our personnel in executive, legal, business development, finance and accounting, and other administrative functions.
We intend to focus our near term research and development efforts on completing the ongoing activities and preparing our programs for a potential transaction or sale. General and Administrative Expenses General and administrative expenses consist primarily of salaries, benefits and share-based compensation for our personnel in executive, legal, business development, finance and accounting, and other administrative functions.
Total Other Income, Net Total other income, net, for the year ended December 31, 2024 was $5.0 million compared to $6.4 million for the year ended December 31, 2023. The decrease in total other income of $1.4 million was primarily due to a decrease in interest income from marketable securities due to a lower excess cash balance.
The increase in total other income of $20.0 million was primarily related to an increase in other income related to the JV Sale; offset by a decrease in interest income from marketable securities due to a lower excess cash balance.
Liquidity and Capital Resources Sources of Liquidity Since our inception, we have funded our operations primarily through equity financings. From our inception and prior to our IPO, we received proceeds of approximately $182.5 million from equity financings.
All common stock, per share and related information included below have been adjusted retroactively, where applicable, to reflect the Reverse Stock Split. Since our inception, we have funded our operations primarily through equity financings. From our inception and prior to our IPO, we received proceeds of approximately $182.5 million from equity financings.
Funding Requirements We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2026.
Funding Requirements We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12 months of the filing of this Annual Report on Form 10-K, and we anticipate that the proposed merger with Candid will be completed in 2026.
There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all. Components of Results of Operations Revenue We do not have any product candidates approved for sale and have not generated any revenue from product sales.
We have not commercialized any products and have never generated revenue from the commercialization of any product. If we are unable to complete the proposed transaction with Candid, we may need to raise additional capital. There can be no assurances, however, that additional funding will be available on terms acceptable to us, or at all.
Results of Operations Comparison of the years ended December 31, 2024 and 2023 The following table summarizes our results of operations: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2024 2023 CHANGE Revenue: Collaboration and license revenue $ 636 $ — $ 636 Total revenue 636 — 636 Operating expenses: Research and development 41,507 53,544 (12,037) General and administrative 19,625 25,388 (5,763) Total operating expenses 61,132 78,932 (17,800) Loss from operations (60,496) (78,932) 18,436 Total other income, net 4,960 6,409 (1,449) Loss before equity in losses of joint venture (55,536) (72,523) 16,987 Loss on investment in joint venture 2,239 2,041 198 Net loss $ (57,775) $ (74,564) $ 16,789 Revenue Collaboration and license revenue was $0.6 million for the year ended December 31, 2024.
In July 2025, we sold our interest in REV102 to Recursion. 90 T a b le of Contents Comparison of the years ended December 31, 2025 and 2024 The following table summarizes our results of operations: FOR THE YEAR ENDED DECEMBER 31, (in thousands) 2025 2024 CHANGE Revenue: Collaboration and license revenue $ 858 $ 636 $ 222 Total revenue 858 636 222 Operating expenses: Research and development 19,597 41,507 (21,910) General and administrative 14,325 19,625 (5,300) Total operating expenses 33,922 61,132 (27,210) Loss from operations (33,064) (60,496) 27,432 Total other income, net 24,960 4,960 20,000 Loss before equity in losses of joint venture (8,104) (55,536) 47,432 Loss on investment in joint venture 874 2,239 (1,365) Net loss $ (8,978) $ (57,775) $ 48,797 Revenue Collaboration and license revenue was $0.9 million for the year ended December 31, 2025, compared to $0.6 million for the year ended December 31, 2024.
Net cash provided by financing activities for the year ended December 31, 2023 was $0.1 million, representing the issuance of common stock under the 2021 Employee Stock Purchase Plan, offset by payments of offering costs related to our November 2022 follow-on offering.
Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 was $16 thousand, representing proceeds from the issuance of common stock under the stock purchase plan.
The decrease of $5.8 million was primarily due to: ▪ a $3.7 million decrease in consulting fees, director and officer insurance premiums, professional fees and other related general and administrative expenses; and ▪ a $2.1 million decrease in payroll and personnel-related costs, primarily related to the workforce reduction, effective March 6, 2024, in addition to lower ongoing headcount in 2024 as compared to 2023.
The decrease of $5.3 million was primarily due to: ▪ a $4.7 million decrease in personnel-related expenses, primarily related to lower ongoing headcount during the year ended December 31, 2025 as compared to the same period in 2024; offset by an increase in personnel-related expenses due to severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025; and ▪ a $0.6 million decrease primarily related to professional fees and other related general and administrative expenses; offset by an increase in legal fees.
These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We have not commercialized any products and have never generated revenue from the commercialization of any product.
Our loss for the year ended December 31, 2025 included a $23.0 million gain in connection with the JV Sale in 2025. As of December 31, 2025, we had an accumulated deficit of $302.0 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations.
Our 93 Table of Contents current plan is that Cohort 1 will evaluate weekly dosing of 150 mg and Cohort 2 will evaluate weekly dosing of 225 mg with 10 weeks of follow-up after the conclusion of treatment. Hematological Disorders In May 2022, we obtained worldwide exclusive rights to RLYB331, a preclinical, monoclonal antibody that is designed to inhibit MTP-2.
Hematological Disorders In May 2022, we obtained worldwide exclusive rights to RLYB331, a preclinical, monoclonal antibody that is designed to inhibit MTP-2. The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load 87 T a b le of Contents and treats ineffective erythropoiesis.
We will need to raise substantial additional capital in the future. Our clinical development costs are expected to increase significantly as our programs advance to later stages of development.
If we are unable to complete the proposed transaction with Candid and continue to progress our product candidates, we will need to raise substantial additional capital in the future to fund the future development of our current programs.
Investing Activities Net cash provided by investing activities was $33.5 million for the year ended December 31, 2024 as compared to $27.7 million of net cash used in investing actives for the year ended December 31, 2023.
Total Other Income, Net Total other income, net, for the year ended December 31, 2025 was $25.0 million compared to $5.0 million for the year ended December 31, 2024.
In addition, we are eligible for payments upon the achievement of certain enrollment-related events, totaling up to $0.7 million. We are also eligible to receive additional payments upon certain triggers related to the companies' FNAIT studies. In addition, we received an equity investment of $6.6 million from Johnson & Johnson Innovation – JJDC, Inc. ("JJDC").
We were also eligible to receive additional payments upon certain triggers related to the companies' FNAIT studies, however, in connection with our decision in April 2025 to discontinue development of RLYB212, we do not expect payments regarding the achievement of certain enrollment-related events.
Together with Recursion, we also advanced REV102, an ENPP1 inhibitor for the treatment of patients HPP to position the molecule for additional preclinical development activities in 2025. In December 2022, we entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.
In July 2025, we announced that we had entered into the ENPP1 Purchase Agreement to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Buyer (a subsidiary of our joint venture partner Recursion).
Our two most advanced programs are in clinical development: RLYB212, an anti-HPA-1a antibody for the prevention of FNAIT and RLYB116, an inhibitor of complement C5, with the potential to treat several diseases of complement dysregulation.
Our lead program, RLYB116, is a differentiated complement C5 inhibitor with the potential to treat diseases of complement dysregulation. In addition, RLYB332, a long-acting MTP-2 antibody for the treatment of diseases of iron overload is currently in preclinical development.
Removed
Since our launch in January 2018, we have built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in the areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders.
Added
Recent Developments On March 1, 2026, we entered into the Merger Agreement with Candid, a clinical-stage biotechnology company advancing a leading portfolio of TCE therapeutics for autoimmune diseases, and Merger Sub, a wholly owned subsidiary of Rallybio.
Removed
RLYB212 is currently in a Phase 2 clinical trial in pregnant women and we plan to initiate a confirmatory PK and PD study of RLYB116 in the second quarter of 2025. Maternal Fetal Blood Disorders RLYB212 is a monoclonal anti-HPA-1a antibody for the prevention of FNAIT, a potentially life-threatening rare hematological disease that impacts fetuses and newborns.
Added
Upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, Merger Sub will be merged with and into Candid, with Candid surviving as a wholly owned subsidiary of Rallybio. The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Removed
We are currently conducting a Phase 2 clinical trial of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT at sites across Europe.
Added
Concurrently with the execution and delivery of the Merger Agreement, certain investors entered into subscription agreements with Candid, pursuant to which such investors have agreed to purchase, immediately prior to the Merger, shares of Candid common stock representing an aggregate commitment of approximately $505.5 million in the Concurrent Financing.
Removed
The primary objective of this single-arm Phase 2 trial is to assess the PK and safety of RLYB212 with secondary objectives that include assessments of pregnancy and neonatal/infant outcomes, and the occurrence of emergent HPA-1a alloimmunization. Subcutaneous administration of RLYB212 will be initiated by Gestational Week 16 and will continue every four weeks through parturition.
Added
The shares of Candid common stock that are issued in the Concurrent Financing will be or will have the right to be, respectively, converted into shares of Rallybio Common Stock in the Merger.
Removed
The Phase 2 trial is designed to enroll participants in three stages: first with a sentinel pregnant woman, an initial Cohort 1 that will include three pregnant women, and a Cohort 2 that will include four pregnant women, for a total target enrollment of eight participants.
Added
Subject to the terms and conditions of the Merger Agreement, at the Effective Time, (a) each then-outstanding share of common stock or preferred stock of Candid (each such share, a “Candid Share”) (excluding any share described in clauses (b) or (c) below and Candid Shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Rallybio Common Stock, calculated in accordance with the Exchange Ratio, (b) each Candid Share issued in the Concurrent Financing will be converted into the right to receive a number of shares of Rallybio Common Stock calculated in accordance with the Merger Agreement, (c) any Candid Shares held as treasury shares or held or owned by Rallybio, Merger Sub or any subsidiary of Rallybio or Candid immediately prior to the Effective Time will be canceled and shall cease to exist, and no consideration shall be delivered in exchange therefor.
Removed
A data review for participants and infants is planned prior to the initiation of each cohort. Following completion of this Phase 2 dose confirmation trial and consultation with regulatory authorities, we expect to initiate a Phase 3 registrational trial. Both the U.S. FDA and EMA have designated RLYB212 as an orphan drug.
Added
Each then-outstanding option to purchase Candid Shares will be converted into an option to purchase Rallybio Common Stock, subject to adjustment as set forth in the Merger Agreement.

… 77 more changes not shown on this page.