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What changed in Compass Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Compass Therapeutics, Inc.'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.

+378 added−431 removedSource: 10-K (2025-12-31) vs 10-K (2024-12-31)

Top changes in Compass Therapeutics, Inc.'s 2025 10-K

378 paragraphs added · 431 removed · 296 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

118 edited+48 added−83 removed206 unchanged
Biggest changePediatric exclusivity is another type of non-patent exclusivity in the United States and, if granted for a biologic, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity for all formulations, dosage forms, and indications of the biologic, including the five-year and three-year non-patent and orphan exclusivity.
Biggest changeAdditionally, for molecularly targeted cancer drugs, beginning after February 3, 2029, the FDA may require testing of certain novel single ingredient or combination regimens to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, including dosing, safety, and preliminary efficacy to inform potential pediatric labeling. 27 Pediatric exclusivity is another type of non-patent exclusivity in the United States and, if granted for a biologic, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity for all formulations, dosage forms, and indications of the biologic, including the five-year and three-year non-patent and orphan exclusivity.
As a result of the TRIGR acquisition, we have assumed all the rights and obligations of the TRIGR License Agreement. CTX-471 (CD137 agonist antibody) We entered into an amended and restated collaboration agreement with Adimab, LLC ("Adimab"), dated February 11, 2015, as amended.
As a result of the TRIGR acquisition, we have assumed all the rights and obligations of the TRIGR License Agreement. CTX-471 (CD137 agonist antibody) We entered into an amended and restated collaboration agreement with Adimab, LLC ("Adimab"), dated February 11, 2015.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions; ● federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; and ● analogous state and foreign law equivalents of each of the above U.S. federal laws, such as anti- kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements; state laws that require the reporting of information related to drug pricing; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; state and local laws that require the licensure of sales representatives; state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require the registration of pharmaceutical sales representatives; data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which adopted the General Data Protection Regulation, which became effective in May 2018); and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions; 35 ● federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; and ● analogous state and foreign law equivalents of each of the above U.S. federal laws, such as anti- kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements; state laws that require the reporting of information related to drug pricing; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; state and local laws that require the licensure of sales representatives; state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require the registration of pharmaceutical sales representatives; data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which adopted the General Data Protection Regulation, which became effective in May 2018); and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.
The process required by the FDA before product candidates may be marketed in the United States generally involves the following: ● completion of extensive nonclinical laboratory tests and nonclinical animal studies, all performed in accordance with the Good Laboratory Practices ("GLP"), regulations; ● submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually; ● approval by an independent institutional review board ("IRB"), or ethics committee representing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices ("GCPs"), to establish the safety and efficacy of the product candidate for each proposed indication; ● preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials; ● review of the product application by an FDA advisory committee, where appropriate and if applicable; 29 ● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities where the proposed product is produced to assess compliance with current Good Manufacturing Practices ("cGMP"); ● satisfactory completion of any FDA audits of the clinical trial sites to assure compliance with GCPs, and the integrity of clinical data in support of the BLA; and ● FDA review and approval of a BLA for a biological product candidate that is safe, pure, and potent prior to any commercial marketing or sale of the product in the United States.
The process required by the FDA before product candidates may be marketed in the United States generally involves the following: ● completion of extensive nonclinical laboratory tests and nonclinical animal studies, all performed in accordance with the Good Laboratory Practices ("GLP"), regulations; ● submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually; ● approval by an independent institutional review board ("IRB"), or ethics committee representing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices ("GCPs"), to establish the safety and efficacy of the product candidate for each proposed indication; ● preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials; ● review of the product application by an FDA advisory committee, where appropriate and if applicable; ● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities where the proposed product is produced to assess compliance with current Good Manufacturing Practices ("cGMP"); ● satisfactory completion of any FDA audits of the clinical trial sites to assure compliance with GCPs, and the integrity of clinical data in support of the BLA; and ● FDA review and approval of a BLA for a biological product candidate that is safe, pure, and potent prior to any commercial marketing or sale of the product in the United States.
American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. ● On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. 40 ● On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020. ● On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.
American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. ● On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. ● On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020. ● On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.
Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; ● the federal Physician Payment Sunshine Act, created under the ACA and its implementing regulations, which requires drug, device, medical supply, and biologics manufacturers to disclose payments under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other licensed healthcare practitioners and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; 42 ● HIPAA, as amended by the Health Information Technology and Clinical Health Act of 2009 ("HITECH"), and its implementing regulations, which imposes, among other things, certain requirements relating to the privacy, security and transmission of individually identifiable health information.
Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; ● the federal Physician Payment Sunshine Act, created under the ACA and its implementing regulations, which requires drug, device, medical supply, and biologics manufacturers to disclose payments under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other licensed healthcare practitioners and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; ● HIPAA, as amended by the Health Information Technology and Clinical Health Act of 2009 ("HITECH"), and its implementing regulations, which imposes, among other things, certain requirements relating to the privacy, security and transmission of individually identifiable health information.
In the United States, these laws include, among others: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration (including any kickback, bribe, or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or for the purchase, lease, order or recommendation of, or arranging for, an item, good, facility or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid.
In the United States, these laws include, among others: 34 ● the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration (including any kickback, bribe, or certain rebates), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or for the purchase, lease, order or recommendation of, or arranging for, an item, good, facility or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid.
A decision by a third-party payor not to cover a product could reduce physician utilization once the product is approved and have a material adverse effect on sales, our operations and financial condition. 39 In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
A decision by a third-party payor not to cover a product could reduce physician utilization once the product is approved and have a material adverse effect on sales, our operations and financial condition. In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
Preclinical and early clinical data of tovecimig as a monotherapy and in combination with chemotherapy suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumor indications, including colorectal, gastric, cholangiocarcinoma, pancreatic and NSCLC. Tovecimig is undergoing clinical development in patients with advanced solid tumors in the United States.
Preclinical and early clinical data of tovecimig as a monotherapy and in combination with chemotherapy suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumor indications, including cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, and NSCLC. Tovecimig is undergoing clinical development in patients with advanced solid tumors in the United States.
After a median follow up of approximately 12 months, the median progression free survival (“PFS”) was 9.4 months, median duration of response (“DOR”) was 6.9 months and median overall survival (“OS”) was 12.5 months. For reference, one regimen that has been studied in patients with advanced BTC is the three-drug combination FOLFOX.
After a median follow up of approximately 12 months, the median progression free survival (“PFS”) was 9.4 months, median duration of response (“DOR”) was 6.9 months and median overall survival (“OS”) was 12.5 months. 8 For reference, one regimen that has been studied in patients with advanced BTC is the three-drug combination FOLFOX.
Patents that grant from these patent families are generally expected to start to expire in 2039, subject to possible patent term extension. We own 1 pending patent family with 1 U.S. pending patent application and 1 patent application in foreign jurisdictions related to our antibody and display programs including, but not limited to, common light chains.
Patents that grant from these patent families are generally expected to start to expire in 2039, subject to possible patent term extension. We own 1 pending patent family with 1 issued U.S. patent and 1 patent application in foreign jurisdictions related to our antibody and display programs including, but not limited to, common light chains.
The content of the BLA filed in the United States is similar to that required in the European Union, with the exception of, among other things, country-specific document requirements. 36 For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing product licensing, pricing, and reimbursement vary from country to country.
The content of the BLA filed in the United States is similar to that required in the European Union, with the exception of, among other things, country-specific document requirements. For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing product licensing, pricing, and reimbursement vary from country to country.
In this circumstance, the EMA ensures that the opinion of the CHMP is given within 150 days, excluding clock stops, but it is possible that the CHMP can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment. 37 National authorization procedures .
In this circumstance, the EMA ensures that the opinion of the CHMP is given within 150 days, excluding clock stops, but it is possible that the CHMP can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment. National authorization procedures .
Phase 1 Clinical Trial Data In July 2019, we initiated a Phase 1 trial evaluating the safety and tolerability of CTX-471 as a monotherapy in patients with solid tumors who were previously treated with PD-1 or PD-L1 immune checkpoint inhibitors and subsequently relapsed or progressed after a period of stable disease.
Phase 1 Clinical Trial of CTX-471 In July 2019, we initiated a Phase 1 trial evaluating the safety and tolerability of CTX-471 as a monotherapy in patients with solid tumors who were previously treated with PD-1 or PD-L1 immune checkpoint inhibitors and subsequently relapsed or progressed after a period of stable disease.
This agreement relates to our license from Adimab for certain antibodies for development and commercialization as biopharmaceutical products, including our product candidate, CTX-471. We were granted an exclusive option to license and potentially acquire antibodies under the agreement, which we exercised with respect to CTX-471.
This agreement relates to our license from Adimab for certain antibodies for development and commercialization as biopharmaceutical products, including our acquired product candidate, CTX-471. We were granted an exclusive option to license and potentially acquire antibodies under the agreement, which we exercised with respect to CTX-471.
The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational biological product to humans in clinical trials.
The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND. 22 An IND is a request for authorization from the FDA to administer an investigational biological product to humans in clinical trials.
The submission procedure is the same irrespective of whether the clinical trial is to be conducted in a single European Union Member State or in more than one European Union Member State. Marketing Authorization Procedures in the European Union Medicines can be authorized in the European Union by using either the centralized authorization procedure or a national authorization procedure.
The submission procedure is the same irrespective of whether the clinical trial is to be conducted in a single European Union Member State or in more than one European Union Member State. 29 Marketing Authorization Procedures in the European Union Medicines can be authorized in the European Union by using either the centralized authorization procedure or a national authorization procedure.
These trials are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. 30 Phase 2 .
These trials are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. Phase 2 .
Factors payors consider in determining reimbursement are based on whether the product is: ● a covered benefit under its health plan; ● safe, effective and medically necessary; ● appropriate for the specific patient; ● cost-effective; and ● neither experimental nor investigational.
Factors payors consider in determining reimbursement are based on whether the product is: ● a covered benefit under its health plan; ● safe, effective and medically necessary; ● appropriate for the specific patient; 31 ● cost-effective; and ● neither experimental nor investigational.
We designated CTX-8371 as the bispecific antibody we constructed using our common light chain antibodies having a PD-1 and PD-L1 antigen binding domain. 17 A PD-1 x PD-L1 bispecific antibody outperformed single PD-1 antibodies in a T-cell activation assay The observation that the combination of a PD-1 and PD-L1 antibody into a bispecific antibody would be hundreds to thousands fold more potent in a T-cell activation assay than a PD-1 antibody alone was unexpected.
We designated CTX-8371 as the bispecific antibody we constructed using our common light chain antibodies having a PD-1 and PD-L1 antigen binding domain. 13 A PD-1 x PD-L1 bispecific antibody outperformed single PD-1 antibodies in a T-cell activation assay The observation that the combination of a PD-1 and PD-L1 antibody into a bispecific antibody would be hundreds to thousands fold more potent in a T-cell activation assay than a PD-1 antibody alone was unexpected.
The Hatch Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review.
The Hatch-Waxman Act permits a patent term extension of up to five years beyond the original expiration of the patent. The length of the patent term extension is related to the length of time the drug is under regulatory review.
Biosimilars and Exclusivity The Patient Protection and Affordable Care Act ("Affordable Care Act"), signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 ("BPCI"), which created an abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product.
Biosimilars and Exclusivity The Patient Protection and Affordable Care Act ("Affordable Care Act"), signed into law on March 23, 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), which created an abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product.
The SEC maintains a website that contains proxy and other information that issuers file electronically with the SEC at www.sec.gov. The contents of the websites referred to above are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only. 44
The SEC maintains a website that contains proxy and other information that issuers file electronically with the SEC at www.sec.gov . The contents of the websites referred to above are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only. 37
We designed the antibody using different backbones and chose to use a human IgG4 backbone for CTX-471 to enable engagement of Fc receptors FcɣRI and FcɣRIIb to facilitate CD137 cross-linking while avoiding binding to FcɣRIIIa and depletion of immune effector cells through ADCC.
We designed the antibody using different backbones and chose to use a human IgG4 backbone for CTX-471 to enable engagement of Fc receptors FcɣRI and FcɣRIIb to facilitate CD137 cross-linking while avoiding binding to FcɣRIIIa and depletion of immune effector cells.
Under the terms of the agreement, ABL Bio and TRIGR would jointly develop tovecimig, with ABL Bio responsible for development of tovecimig throughout the end of Phase 1 clinical trials and TRIGR responsible for the development of tovecimig from Phase 2 and onward. 24 ABL Bio received a $5 million upfront payment and a $6 million milestone payment.
Under the terms of the agreement, ABL Bio and TRIGR would jointly develop tovecimig, with ABL Bio responsible for development of tovecimig throughout the end of Phase 1 clinical trials and TRIGR responsible for the development of tovecimig from Phase 2 and onward. 17 ABL Bio received a $5 million upfront payment and a $6 million milestone payment.
We are required to make payments upon achievement of development milestones that, as of December 31, 2024, amounted to $3.5 million, of which we have already made $1.5 million in milestone payments, and we have additional potential payments due in the amount of $2.0 million.
We are required to make payments upon achievement of development milestones that, as of December 31, 2025, amounted to $3.5 million, of which we have already made $1.5 million in milestone payments, and we have additional potential payments due in the amount of $2.0 million.
If reports of FDA-requested pediatric trials are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection covering the product are extended by six months.
If reports of FDA-requested pediatric trials are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity covering the product are extended by six months.
Our second program CTX-471, is an agonistic antibody targeting a member of the tumor necrosis factor receptor superfamily member 9 (TNFRSF9), also known as CD-137, a co-stimulatory receptor which is mostly expressed on activated, but not on resting, T-cells and NK cells.
Our second program, CTX-471, is an agonistic antibody targeting a member of the tumor necrosis factor receptor superfamily member 9 (TNFRSF9), also known as CD-137 or 4-1BB, a co-stimulatory receptor which is mostly expressed on activated, but not on resting, T-cells and NK cells.
We seek protection, in part, through confidentiality and proprietary information agreements. 25 The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.
We seek protection, in part, through confidentiality and proprietary information agreements. 18 The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.
CTX-471, our CD137 agonistic antibody, targets a key node of the immune system with the goal of becoming a next generation immune-oncology treatment for patients across a variety of cancers who do not have a sustained response to current therapies.
CTX-471, our CD137 (or 4-1BB) agonistic antibody, targets a key node of the immune system with the goal of becoming a next generation immune-oncology treatment for patients across a variety of cancers who do not have a sustained response to current therapies.
Nine PRs confirmed by RECIST 1.1 were observed leading to an ORR of 37.5%, and 22 of the 24 patients evaluated have had stable disease or better with a decline in tumor burden leading to a CBR of 92%. PRs were observed in all four tumor sub-types types (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).
Nine PRs confirmed by RECIST 1.1 were observed leading to an ORR of 37.5%, and 22 of the 24 patients evaluated have had stable disease or better with a decline in tumor burden leading to a Disease Control Rate (DCR) of 92%. PRs were observed in all four tumor sub-types types (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).
First line treatment of locally advanced or metastatic BTC includes the chemotherapy combination of gemcitabine and cisplatin, often with the addition of the PD-1 inhibitor Imfinzi® (durvalumab). In September of 2022, AstraZeneca received FDA approval of durvalumab in combination with gemcitabine/cisplatin for the first line treatment of BTC.
First line treatment of locally advanced or metastatic BTC includes the chemotherapy combination of gemcitabine and cisplatin, often with the addition of the PD-L1 inhibitor Imfinzi® (durvalumab) or PD-1 inhibitor Keytruda (pemrolizumab). In September of 2022, AstraZeneca received FDA approval of durvalumab in combination with gemcitabine/cisplatin for the first line treatment of BTC.
As an emerging company operating in a competitive industry, much of our success is rooted in the diversity of our teams and our commitment to inclusion.
As a company operating in a competitive industry, much of our success is rooted in the diversity of our teams and our commitment to inclusion.
The design of this trial included a Phase 1a dose escalation stage followed by a Phase 1b dose expansion stage. In the Phase 1a dose escalation, CTX-471 was observed to be generally well-tolerated in the Phase 1a stage of the trial.
The design of this trial included a Phase 1a dose escalation stage followed by a Phase 1b dose expansion stage. In the Phase 1a dose escalation, CTX-471 was observed to be generally well-tolerated in the Phase 1a stage of the trial. The dose-limiting toxicity was thrombocytopenia.
We intend to assess on a case-by-case basis the opportunities for accelerating the preclinical development, clinical development and commercialization of these candidates in a capital-efficient manner, including selectively pursuing strategic partnerships with leading biopharmaceutical companies with domain-specific clinical development and commercial expertise to maximize the value of our pipeline.
We intend to assess on a case-by-case basis the opportunities for accelerating the preclinical development, clinical development and commercialization of these candidates in a capital-efficient manner, including selectively pursuing strategic partnerships with leading biopharmaceutical companies with domain-specific clinical development and commercial expertise to maximize the value of our pipeline. 6 Pipeline The figure below details our pipeline of product candidates.
Patients with BTC have a poor prognosis despite first-line treatment with chemotherapy and immunotherapy, and there is no generally accepted standard of care in later lines of treatment, except for therapies for targeted mutations, which is estimated to be approximately 15% of the market.
Patients with BTC have a poor prognosis despite first-line treatment with chemotherapy and immunotherapy, and there is no generally accepted standard of care in later lines of treatment, except for therapies addressing targeted mutations, which is estimated to be approximately 15% to 20% of the patient population.
Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, and others may be ineffective, and violations of the FCPA and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, financial condition and result of operations. 43 Employees and Human Capital As of December 31, 2024, we had 35 employees, 22 of which were primarily engaged in research and development and clinical activities.
Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, and others may be ineffective, and violations of the FCPA and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, financial condition and result of operations. 36 Employees and Human Capital As of December 31, 2025, we had 39 employees, 25 of which were primarily engaged in research and development and clinical activities.
A Phase 1 dose escalation and dose expansion monotherapy trial in patients with solid tumors, a Phase 1b trial of tovecimig in combination with chemotherapy and a Phase 2 trial of tovecimig in combination with chemotherapy in patients with advanced biliary tract cancer were completed in South Korea.
Previously, tovecimig underwent a Phase 1 dose escalation and dose expansion monotherapy trial in patients with solid tumors, a Phase 1b trial in combination with chemotherapy, and a Phase 2 trial in combination with chemotherapy in patients with advanced biliary tract cancer, all of which were completed in South Korea.
In addition to these marketed therapies, numerous compounds are in clinical development for the potential treatment of cancer. 27 Biliary tract cancers are aggressive and rare gastrointestinal cancers that have a very poor prognosis.
In addition to these marketed therapies, numerous compounds are in clinical development for the potential treatment of cancer. 20 Biliary tract cancers are aggressive gastrointestinal cancers that have a very poor prognosis.
We own 4 pending patent families with 11 issued U.S. patents and issued patents in Taiwan, China, Eurasia, Japan, Korea, Malaysia, Singapore, and New Zealand, 3 U.S. patent applications, and 39 patent applications in foreign jurisdictions, related to our CD137 agonist antibody therapeutic platform including, but not limited to, our CTX-471 therapeutic candidate.
We own 4 pending patent families with 10 issued U.S. patents and issued patents in Taiwan, China, Eurasia, Israel, Japan, Korea, Malaysia, Mexico, Singapore, and New Zealand, 3 U.S. patent applications, and 35 patent applications in foreign jurisdictions, related to our CD137 agonist antibody therapeutic platform including, but not limited to, our CTX-471 therapeutic candidate.
Patents that grant from these patent families are generally expected to start to expire in 2039, subject to possible patent term extension. We own, or have an ownership interest in, 2 pending patent families with 2 U.S. pending patent applications and 3 patent applications in foreign jurisdictions, related to our CD277 discovery and research programs.
Patents that grant from these patent families are generally expected to start to expire in 2039, subject to possible patent term extension. 19 We own, or have an ownership interest in, 2 pending patent families with 1 issued patent in the U.S., 1 U.S. pending patent application and 2 patent applications in foreign jurisdictions, related to our CD277 discovery and research programs.
This amendment to the PHSA attempts to minimize duplicative testing. Biosimilarity, which requires that there be no clinically meaningful differences between the proposed biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical trial or trials.
This amendment to the Public Health Service Act (“PHSA”) attempts to minimize duplicative testing. Biosimilarity, which requires that there be no clinically meaningful differences between the proposed biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical trial or trials.
While PD-1/PD-L1 checkpoint therapies have resulted in remarkable clinical efficacy across multiple cancer types, their efficacy, even in tumors with high immunogenicity, is limited to approximately 20% of patients. Nevertheless, sales of checkpoint therapies in 2023 were estimated to be $48 billion. There is no approved therapy that combines inhibition of both PD-1 and PD-L1 in the same molecule.
While PD-1/PD-L1 checkpoint therapies have resulted in remarkable clinical efficacy across multiple cancer types, their efficacy, even in tumors with high immunogenicity, is limited to approximately 20% of patients. Nevertheless, aggregate sales for checkpoint therapies is currently estimated to be approximately $50 billion. There is no approved therapy that combines inhibition of both PD-1 and PD-L1 in the same molecule.
FOLFOX demonstrated an ORR of 5%, a median PFS of 4.0 months, and a median OS of 6.2 months in a randomized study against best supportive care. 11 The waterfall plot below depicts the best response for the 22 patients evaluated in the trial.
FOLFOX demonstrated an ORR of 4.9%, a median PFS of 4.0 months, and a median OS of 6.2 months in a randomized study against best supportive care. The waterfall plot below depicts the best response for the 22 patients evaluable in the trial.
We have 7 patents issued in the United States and issued patents in Taiwan, China, Eurasia, Japan, Korea, Malaysia, Singapore and New Zealand related to our CTX-471 program, and 2 patents issued in the United States, and issued patents in China, Japan and Taiwan, related to our CTX-8371 program.
We have 7 patents issued in the United States and 23 issued patents in Taiwan, China, Eurasia, Japan, Korea, Malaysia, Singapore and New Zealand related to our CTX-471 program, and 3 patents issued in the United States, and 8 issued patents in China, Japan, Malaysia, Mexico, and Taiwan, related to our CTX-8371 program.
(“TRIGR”) and ABL Bio, a South Korean biotechnology company, entered into an exclusive global (excluding South Korea) license agreement (the “TRIGR License Agreement”) which granted TRIGR a license to ABL001, ABL Bio’s bispecific antibody targeting DLL4 and VEGF-A (renamed CTX-009 and subsequently tovecimig).
(“TRIGR”) and ABL Bio, a South Korean biotechnology company, entered into an exclusive global (excluding South Korea) license agreement (the “TRIGR License Agreement”) which granted TRIGR a license to ABL001 (renamed CTX-009 and subsequently tovecimig).
For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively, the Affordable Care Act ("ACA"), among other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program, increases rebates for drugs sold to Medicaid programs owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and created a mandatory discount program for certain Medicare Part D beneficiaries in which manufacturers must agree 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively, the Affordable Care Act ("ACA"), among other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program, increases rebates for drugs sold to Medicaid programs owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and created a mandatory discount program for certain Medicare Part D beneficiaries in which manufacturers must agree 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. 32 In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted: ● On August 2, 2011, the U.S.
As of January 31, 2025, we have greater than 90 issued patents and patent applications pending in the United States and foreign jurisdictions relating to tovecimig, CTX-471, CTX-8371, CTX-10726 and other discovery and research programs.
As of January 31, 2026, we have nearly 100 issued patents and patent applications pending in the United States and foreign jurisdictions relating to tovecimig, CTX-471, CTX-8371, CTX-10726, and other discovery and research programs.
Initial results reported from the study included five clinical responses, including a durable PR in a patient with SCLC that converted to a complete response (as confirmed by PET scan) and four additional PRs (one unconfirmed) in patients with melanoma and mesothelioma. The ORR in the subset of patients with advanced melanoma was 27% (3 of 11).
Initial results reported from the study included five clinical responses, including a durable PR in a patient with SCLC that converted to a complete response (as confirmed by PET scan) and four additional PRs (three confirmed by RECIST 1.1 and one unconfirmed) in patients with melanoma (3 out of 11 patients) and mesothelioma (1 out of 4 patients).
The primary endpoint of the trial is ORR and the secondary endpoints include PFS, OS, DOR and DCR among others. Patients who were randomized to receive paclitaxel and have progressed on their regimen can cross over to the tovecimig plus paclitaxel arm after progression on paclitaxel if they still meet the enrollment criteria for the study.
The primary endpoint of the trial was ORR and the secondary endpoints include PFS, OS, and DOR. Patients who were randomized to receive paclitaxel and progressed on their regimen could cross over to the tovecimig plus paclitaxel arm after progression on paclitaxel if they still met the enrollment criteria for the study.
Sponsors must also report to the FDA, within certain timeframes, serious and unexpected adverse reactions, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product candidate.
Expansion cohort trials can potentially bring efficiency to drug development and reduce development costs and time. 23 Sponsors must also report to the FDA, within certain timeframes, serious and unexpected adverse reactions, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product candidate.
We designed our combinatorial screen such that one antigen-binding domain was directed against PD-1, and the other selected from our library of candidate antibodies. We screened these StitchMabs TM bispecific constructs in T-cell activation assays in the presence of PD-L1 expressing cells.
We designed our combinatorial screen such that one antigen-binding domain was directed against PD-1, and the other selected from our library of candidate antibodies. We screened these bispecific constructs in T-cell activation assays in the presence of PD-L1 expressing cells. Our unbiased screening led us to an antibody that pairs a PD-1 binding domain and a PD-L1 binding domain.
In contrast to those bispecific efforts described by others that have focused on a single pair of antigen-binding domains at a time, we have applied our StitchMabs TM technology to broadly screen for pairs of bispecific antigen-binding domains with the highest potential to generate antitumor activity.
In contrast to those bispecific efforts described by others that have focused on a single pair of antigen-binding domains at a time, we applied our StitchMabs TM technology in combination with our broad portfolio of selective antibodies to of immune targets across the innate and adaptive immune system to broadly screen for pairs of bispecific antigen-binding domains with the highest potential to generate antitumor activity.
In treated mice, dosing with CTX-471 led to extensive reprogramming of the tumor microenvironment, including increased recruitment of immune cells, reversal of exhausted cytotoxic CD8+ T-cells, reductions in immunosuppressive regulatory T-cells and reductions in immunosuppressive tumor-associated macrophages.
Binding of CTX-471 to CD137 has been observed to lead to ligand-stimulated activation of T-cells and NK cells. In treated mice, dosing with CTX-471 led to extensive reprogramming of the tumor microenvironment, including increased recruitment of immune cells, reversal of exhausted cytotoxic CD8+ T-cells, reductions in immunosuppressive regulatory T-cells and reductions in immunosuppressive tumor-associated macrophages.
Our third program, CTX-8371, is a bispecific antibody targeting the programmed cell death protein-1 (“PD-1”), an inhibitory immune checkpoint receptor and its ligand PD-L1, two validated immune-oncology targets. In addition, we are in the process of IND enabling studies with CTX-10726, a bispecific antibody targeting PD-1 and VEFG-A.
Our third program, CTX-8371, is a bispecific antibody targeting the programmed cell death protein-1 (“PD-1”), an inhibitory immune checkpoint receptor, and its ligand PD-L1, two validated immune-oncology targets. Our fourth program, CTX-10726, is a bispecific antibody targeting PD-1 and VEFG-A.
Tovecimig (CTX-009), our bispecific antibody targeting DLL4 and VEGF-A, is currently being evaluated in a randomized Phase 2/3 trial in the United States in combination with paclitaxel in patients with biliary tract cancer (“BTC”) who received one prior treatment regimen. We expect top-line data from this study at the end of the first quarter of 2025.
Tovecimig (CTX-009), our bispecific antibody targeting DLL4 and VEGF-A, is currently being evaluated in a randomized Phase 2/3 trial in the United States in combination with paclitaxel in patients with biliary tract cancer (“BTC”) who received one prior treatment regimen.
Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, 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. 35 Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA.
Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, 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.
To determine eligibility for RTOR, the FDA requires top-line efficacy and safety results from an applicant. 33 Post-Approval Requirements Biological products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
Post-Approval Requirements Biological products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product.
Two of these four patients had deep, durable, and confirmed responses. Both of these patients received tovecimig in combination with paclitaxel. Based on this observation, a Phase 2 trial of tovecimig in combination with paclitaxel was completed by ABL Bio in patients with BTC, with data reported in the first quarter of 2023.
Both of these patients received tovecimig in combination with paclitaxel. Based on this observation, a Phase 2 trial of tovecimig in combination with paclitaxel was completed by Handok and Compass in patients with BTC, with data reported in the first quarter of 2023.
The trial is designed to assess the safety and efficacy of the combination of tovecimig and paclitaxel versus paclitaxel alone. A schema of the trial design is provided below: The trial was designed to enroll 150 patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=100) or paclitaxel alone (n=50).
The trial is designed to assess the safety and efficacy of the combination of tovecimig and paclitaxel versus paclitaxel alone. A schema of the trial design is provided below: The trial was fully enrolled in August 2024 with 168 patients randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57).
Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption.
Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.
Based on preclinical studies, CTX-10726 exhibits several-fold more potent PD-1 blockade compared with publicly available data reported for other drugs in the class, and we believe this may be a key differentiator from comparable bispecifics.
CTX-10726 utilizes a fully human IgG1 with silenced Fc-γ receptor binding and demonstrates a highly stable structure with high affinity target binding. Based on preclinical studies, CTX-10726 exhibits several-fold more potent PD-1 blockade compared with publicly available data reported for other drugs in the class, and we believe this may be a key differentiator from comparable bispecifics.
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. 34 Pediatric Trials and Exclusivity A sponsor who is planning to submit a marketing application for a biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must submit an initial Pediatric Study Plan ("PSP"), within sixty days of an end of Phase 2 meeting or as may be agreed between the sponsor and FDA.
Pediatric Trials and Exclusivity A sponsor who is planning to submit a marketing application for a biological product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must submit an initial Pediatric Study Plan ("PSP"), within sixty days of an end of Phase 2 meeting or as may be agreed between the sponsor and FDA.
Further investigation into the mechanism of CTX-8371 found that it led to T-cell activation through four mechanisms: ● Dual checkpoint blocker : preventing PD-L1 to PD-1 binding, thus relieving the immunosuppressive PD-1 signal; ● Cell engager : bridging the connection between the PD-L1 expressing tumor cell and the PD-1 expressing T-cell, potentially facilitating T-cell engagement and enhancement of effector function; ● Downregulation of PD-1 : triggering the shedding of the extracellular domain of PD-1 receptors from the surface of T-cells resulting in a reduction in the levels of PD-1 on T-cells; and ● Indirect CD28 agonist: increasing the pool of free CD80 on tumor cells making it available to bind and activate the CD28 T-cell co-stimulatory receptor, thereby, sending a positive signal to the T-cell, which enhances its activation. 18 Differentiated mechanism of action of CTX-8371 drives enhanced T-cell activation We also found that the greater activity of CTX-8371 in our T-cell activation assay compared to PD-1 inhibition also extended to PD-L1 inhibition.
Further investigation into the mechanism of CTX-8371 found that it led to T-cell activation through four synergistic mechanisms: ● Dual checkpoint blocker : preventing PD-L1 to PD-1 binding, thus relieving the immunosuppressive PD-1 signal; ● Cell engager : bridging the connection between the PD-L1 expressing tumor cell and the PD-1 expressing T-cell, potentially facilitating T-cell engagement and enhancement of effector function; ● Downregulation of PD-1 : triggering the cleavage of the extracellular domain of PD-1 receptors from the surface of T-cells resulting in the conversion of PD-1 positive T-cells into PD-1 negative; and ● Indirect CD28 agonist: increasing the pool of free CD80 on tumor cells making it available to bind and activate the CD28 T-cell co-stimulatory receptor, thereby, sending a positive signal to the T-cell, which enhances its activation. 14 Differentiated mechanism of action of CTX-8371 drives enhanced T-cell activation Phase 1 and Development Plans for CTX-8371 In the first quarter of 2024 we initiated a first-in-human Phase 1 study of CTX-8371 in patients with metastatic or locally advanced malignancies.
We completed enrollment of a randomized Phase 2/3 trial of tovecimig in combination with paclitaxel in patients with BTC and a Phase 2 trial of tovecimig in patients with advanced CRC.
We are currently conducting a randomized Phase 2/3 trial of tovecimig in combination with paclitaxel in patients with advanced BTC.
The development of CTX-10726 was informed and accelerated by our experience with two of our clinical-stage assets: tovecimig, which contains a VEGF-A targeted component, and CTX-8371, which contains a PD-1 targeted component. We are continuing IND-enabling studies and expect to file an IND by the end of 2025.
The development of CTX-10726 was informed and accelerated by our experience with two of our clinical-stage assets: tovecimig, which contains a VEGF-A targeted component, and CTX-8371, which contains a PD-1 targeted component.
The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials.
The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials. Such post-market testing may include Phase 4 clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.
We expect to initiate a Phase 2 basket study of CTX-471 in patients with NCAM+ tumors in mid-2025. 7 CTX-8371, our bispecific antibody targeting PD-1 and PD-L1, is currently in a first-in-human Phase 1 clinical trial. CTX-8371 emerged from an unbiased screen for synergy conducted with our StitchMabs TM platform.
We expect to initiate a Phase 2 basket study of CTX-471 in patients with NCAM+ tumors in mid-2026. 5 CTX-8371, our bispecific antibody targeting PD-1 and PD-L1, is currently in a first-in-human Phase 1 clinical trial.
Companies applying for a marketing authorization in the Europea Union must also agree upon a pediatric investigation plan (“PIP”) with the EMA’s Pediatric Committee and must conduct pediatric clinical trials in accordance with that PIP unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP.
Companies applying for a marketing authorization in the Europea Union must also agree upon a pediatric investigation plan (“PIP”) with the EMA’s Pediatric Committee and must conduct pediatric clinical trials in accordance with that PIP unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. 30 Data and Market Exclusivity in the European Union In the European Union, innovative medicinal products approved on the basis of a complete and independent data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity.
Of the 24 patients enrolled in the first stage of the trial, all patients had at least one treatment emergent adverse event (“TEAE”). Grade 3 or greater TEAEs were reported in 95.8% of patients regardless of the relationship to tovecimig or paclitaxel, including decreased neutrophil count (83.3%), hypertension (16.7%), anemia (20.8%), and decreased platelet count (12.5%).
Grade 3 or greater TEAEs were reported in 95.8% of patients regardless of the relationship to tovecimig or paclitaxel, including decreased neutrophil count (83.3%), hypertension (16.7%), anemia (20.8%), and decreased platelet count (12.5%).
In the preliminary analysis of all 24 patients participating in the study, tovecimig with paclitaxel demonstrated a 37.5% ORR based on 9 patients with PRs that were confirmed by RECIST 1.1.
In the preliminary analysis of 24 patients participating in the study, tovecimig with paclitaxel demonstrated a 37.5% ORR based on 9 patients with PRs that were confirmed by RECIST 1.1. The results of Part 1 of the Phase 2 trial were presented at the 2023 ASCO GI meeting in January 2023.
Expedited Review and Accelerated Approval Programs A sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of BLAs. For example, fast track designation may be granted to a biological product intended for treatment of a serious or life-threatening disease or condition that has potential to address unmet medical needs.
For example, fast track designation may be granted to a biological product intended for treatment of a serious or life-threatening disease or condition that has potential to address unmet medical needs.
Applications for orphan drug products are exempted from the BLA application fee and may be exempted from program fees, unless the application includes an indication for other than a rare disease or condition. 31 A BLA must include all relevant data available from pertinent nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things.
A BLA must include all relevant data available from pertinent nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things.
In mouse xenografts, treatment with CTX-8371 led to significantly greater tumor growth control and longer survival than treatment with a PD-1 inhibitor alone, a PD-L1 inhibitor alone or the combination of PD-1 and PD-L1 inhibitors. IND-enabling studies on CTX-8371, including GLP toxicology studies in non-human primates (“NHPs”) were completed in the first quarter of 2023.
In mouse xenografts, treatment with CTX-8371 led to significantly greater tumor growth control and longer survival than treatment with a PD-1 inhibitor alone, a PD-L1 inhibitor alone or the combination of PD-1 and PD-L1 inhibitors.
We have relied on, and intend to continue to rely on, qualified third-party contract manufacturers to produce our product candidates, including clinical supplies to support our clinical trials.
Manufacturing We do not currently own or operate manufacturing facilities for the production of clinical quantities of our product candidates. We have relied on, and intend to continue to rely on, qualified third-party contract manufacturers to produce our product candidates, including clinical supplies to support our clinical trials.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical 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, designed to encourage importation from other countries and bulk purchasing. 41 Other Healthcare Laws and Compliance Requirements Healthcare providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical 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, designed to encourage importation from other countries and bulk purchasing.
Our unbiased screening led us to an antibody that pairs a PD-1 binding domain and a PD-L1 binding domain. This novel bispecific antibody contributed to T-cell activation that outperformed the activation observed in response to treatment with only PD-1 antibodies.
This novel bispecific antibody contributed to T-cell activation that outperformed the activation observed in response to treatment with only PD-1 antibodies.
We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. Our pipeline comprises three clinical product candidates and one candidate in investigational new drug application (“IND”) enabling studies.
We plan to advance our product candidates through clinical development and commercialization as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. Our pipeline consists of four clinical product candidates.
We expect to accelerate the development of CTX-10726 by leveraging our experience developing and manufacturing bispecific structures containing VEGF-A (tovecimig) and PD-1 (CTX-8371) components. Pipeline The figure below details our pipeline of product candidates. Our Strategy Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth.
In early 2026, we received FDA clearance for the IND for CTX-10726 and initiated a Phase 1 dose escalation study. We expect to accelerate the development of CTX-10726 by leveraging our experience developing and manufacturing bispecific structures containing the VEGF-A and PD-1 components. Our Strategy Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth.
The FDA cleared the IND for CTX-8371 in the fourth quarter of 2023 and the first patient in the Phase 1 clinical trial was dosed in April 2024. 16 CTX-8371 is a PD-1 x PD-L1 bispecific antibody Overview of PD-1 and PD-L1 Checkpoint Inhibitors PD-L1 is a surface protein that is overexpressed by over 35% of certain types of cancer, such as melanoma, hepatocellular carcinoma, CRC, and NSCLC.
CTX-8371 is a PD-1 x PD-L1 bispecific antibody Overview of PD-1 and PD-L1 Checkpoint Inhibitors PD-L1 is a surface protein that is overexpressed by over 35% of certain types of cancer, such as melanoma, hepatocellular carcinoma, CRC, and NSCLC.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe clinical and commercial success of our current and future product candidates will depend on several factors, including the following: ● timely and successful completion of preclinical studies and our clinical trials; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● our plans to successfully submit new INDs with the FDA for our current and future product candidates; ● our ability to complete preclinical studies for current or future product candidates; ● successful enrollment in, and completion of clinical trials; ● successful data from our clinical program that supports an acceptable risk-benefit profile of our product candidates in the intended patient populations; ● our ability to establish agreements with third-party manufacturers on a timely and cost-efficient manner; ● whether we are required by the FDA or comparable foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned or anticipated to support approval of our product candidates; ● acceptance of our proposed indications and the primary endpoint assessments evaluated in the clinical trials of our product candidates by the FDA and comparable foreign regulatory authorities; ● receipt and maintenance of timely marketing approvals from applicable regulatory authorities; ● successfully launching commercial sales of our product candidates, if approved; ● the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if approved; 49 ● entry into collaborations to further the development of our product candidates; ● obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates; ● acceptance of the benefits and uses of our product candidates, if approved, by patients, the medical community and third-party payors; ● maintaining a continued acceptable safety, tolerability and efficacy profile of the product candidates following approval; ● our compliance with any post-approval requirements imposed on our products, such as post-marketing studies, REMS or additional requirements that might limit the promotion, advertising, distribution or sales of our products or make the products cost prohibitive; ● competing effectively with other therapies; ● obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; ● our ability to identify bispecifics; and ● enforcing and defending intellectual property rights and claims.
Biggest changeOur current product candidates and any future product candidates we develop will require additional preclinical or clinical development, management of clinical, preclinical and manufacturing activities, marketing approval in the United States and other jurisdictions, demonstration of effectiveness to pricing and reimbursement authorities, sufficient cGMP manufacturing supply for both preclinical and clinical development and commercial production, building of a commercial organization and substantial investment and significant marketing efforts before we generate any revenues from product sales. 41 The clinical and commercial success of our current and future product candidates will depend on several factors, including the following: ● timely and successful completion of preclinical studies and our clinical trials; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● our plans to successfully submit new INDs with the FDA for our current and future product candidates; ● our ability to complete preclinical studies for current or future product candidates; ● successful enrollment in, and completion of clinical trials; ● successful data from our clinical program that supports an acceptable risk-benefit profile of our product candidates in the intended patient populations; ● our ability to establish agreements with third-party manufacturers on a timely and cost-efficient manner; ● whether we are required by the FDA or comparable foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned or anticipated to support approval of our product candidates; ● acceptance of our proposed indications and the primary endpoint assessments evaluated in the clinical trials of our product candidates by the FDA and comparable foreign regulatory authorities; ● receipt and maintenance of timely marketing approvals from applicable regulatory authorities; ● successfully launching commercial sales of our product candidates, if approved; ● the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if approved; ● entry into collaborations to further the development of our product candidates; ● obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates; ● acceptance of the benefits and uses of our product candidates, if approved, by patients, the medical community and third-party payors; ● maintaining a continued acceptable safety, tolerability and efficacy profile of the product candidates following approval; ● our compliance with any post-approval requirements imposed on our products, such as post-marketing studies, REMS or additional requirements that might limit the promotion, advertising, distribution or sales of our products or make the products cost prohibitive; ● competing effectively with other therapies; 42 ● obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; ● our ability to identify bispecifics; and ● enforcing and defending intellectual property rights and claims.
In addition, the FDA currently requires, unless otherwise informed by the agency, as a condition for accelerated approval pre-approval of promotional materials for products being considered for accelerated approval, which could adversely impact the timing of the commercial launch of the product.
In addition, the FDA currently requires, unless otherwise informed by the agency, as a condition for accelerated approval pre-approval of promotional materials for products being considered for accelerated approval, unless otherwise informed by the FDA, which could adversely impact the timing of the commercial launch of the product.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.
We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the product candidates we develop, including: ● results from preclinical studies or clinical trials may not be predictive of results from later clinical trials of any product candidate; ● the FDA or other regulatory authorities, Institutional Review Boards ("IRBs"), or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● the FDA or other regulatory authorities may require us to submit additional data such as long-term toxicology studies, or impose other requirements on us, before permitting us to initiate a clinical trial; ● we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations ("CROs"), as the terms of these agreements can be subject to extensive negotiation and vary significantly among different CROs and trial sites; ● clinical trials of any product candidate may fail to show safety, purity or potency, or may produce negative or inconclusive results, which may cause us to decide, or regulators to require us, to conduct additional nonclinical studies or clinical trials or which may cause us to decide to abandon product candidate development programs; ● the number of patients required for clinical trials may be larger than we anticipate, or we may have difficulty in recruiting and enrolling patients to participate in clinical trials, including as a result of the size and nature of the patient population, the proximity of patients to clinical trial sites, eligibility criteria for the clinical trial, the nature of the clinical trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and clinical trial subjects; ● enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or may fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our CROs and other third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; ● we may elect to, or regulators, IRBs or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks; ● any of our product candidates could cause undesirable side effects that could result in significant negative consequences, including the inability to enter clinical development or receive regulatory approval; ● the cost of preclinical or nonclinical testing and studies and clinical trials of any product candidates may be greater than we anticipate; ● we may face hurdles in addressing subject safety concerns that arise during the course of a trial, causing us or our investigators, regulators, IRBs or ethics committees to suspend or terminate trials, or reports may arise from nonclinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates; 51 ● the supply, quality or timeliness of delivery of materials for product candidates we develop or other materials necessary to conduct clinical trials may be insufficient or inadequate; and ● we may need to change the manufacturing site and potentially the contract development manufacturing organizations ("CDMO") for our product candidates from those that are able to produce clinical supply for our Phase 1 clinical trials to those with the capacity and ability to perform commercial manufacturing and/or the production of clinical material for our later stage clinical trials.
We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the product candidates we develop, including: ● results from preclinical studies or clinical trials may not be predictive of results from later clinical trials of any product candidate; ● the FDA or other regulatory authorities, Institutional Review Boards ("IRBs"), or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● the FDA or other regulatory authorities may require us to submit additional data such as long-term toxicology studies, or impose other requirements on us, before permitting us to initiate a clinical trial; ● we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations ("CROs"), as the terms of these agreements can be subject to extensive negotiation and vary significantly among different CROs and trial sites; ● clinical trials of any product candidate may fail to show safety, purity or potency, or may produce negative or inconclusive results, which may cause us to decide, or regulators to require us, to conduct additional nonclinical studies or clinical trials or which may cause us to decide to abandon product candidate development programs; ● the number of patients required for clinical trials may be larger than we anticipate, or we may have difficulty in recruiting and enrolling patients to participate in clinical trials, including as a result of the size and nature of the patient population, the proximity of patients to clinical trial sites, eligibility criteria for the clinical trial, the nature of the clinical trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and clinical trial subjects; 43 ● enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or may fail to return for post-treatment follow-up at a higher rate than we anticipate; ● our CROs and other third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; ● we may elect to, or regulators, IRBs or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks; ● any of our product candidates could cause undesirable side effects that could result in significant negative consequences, including the inability to enter clinical development or receive regulatory approval; ● the cost of preclinical or nonclinical testing and studies and clinical trials of any product candidates may be greater than we anticipate; ● we may face hurdles in addressing subject safety concerns that arise during the course of a trial, causing us or our investigators, regulators, IRBs or ethics committees to suspend or terminate trials, or reports may arise from nonclinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates; ● the supply, quality or timeliness of delivery of materials for product candidates we develop or other materials necessary to conduct clinical trials may be insufficient or inadequate; and ● we may need to change the manufacturing site and potentially the contract development manufacturing organizations ("CDMO") for our product candidates from those that are able to produce clinical supply for our Phase 1 clinical trials to those with the capacity and ability to perform commercial manufacturing and/or the production of clinical material for our later stage clinical trials.
For example: ● others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license or may own in the future; ● we, or any partners or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future; ● we, or any partners or collaborators, might not have been the first to file patent applications covering certain of our or their inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; ● it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents; 82 ● issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors; ● our competitors 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 may not develop additional proprietary technologies that are patentable; ● the patents of others may have an adverse effect on our business; and ● we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
For example: ● others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license or may own in the future; ● we, or any partners or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future; ● we, or any partners or collaborators, might not have been the first to file patent applications covering certain of our or their inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights; ● it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents; ● issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors; ● our competitors 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 may not develop additional proprietary technologies that are patentable; ● the patents of others may have an adverse effect on our business; and ● we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
Some of these provisions include: ● a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; ● a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; ● a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; ● advance notice requirements for stockholder proposals and nominations for election to our board of directors; ● a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; ● a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and ● the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock.
Some of these provisions include: ● a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; ● a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; ● a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; ● advance notice requirements for stockholder proposals and nominations for election to our board of directors; ● a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; 83 ● a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and ● the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock.
If any of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw their approval of the product; ● we may be required to recall a product or change the way such product is administered to patients; ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; ● we may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients; ● we could be sued and held liable for harm caused to patients; ● the product may become less competitive; and ● our reputation may suffer.
If any of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw their approval of the product; ● we may be required to recall a product or change the way such product is administered to patients; ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof; ● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; 48 ● we may be required to implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients; ● we could be sued and held liable for harm caused to patients; ● the product may become less competitive; and ● our reputation may suffer.
The market price of shares of our common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: ● results of clinical trials of our product candidates; ● the timing of the release of results of our clinical trials; ● results of clinical trials of our competitors’ products; ● safety issues with respect to our products or our competitors’ products; ● regulatory actions with respect to our products or our competitors’ products; ● actual or anticipated fluctuations in our financial condition and operating results; ● publication of research reports by securities analysts about us or our competitors or our industry; ● our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; ● additions and departures of key personnel; 99 ● strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; ● the passage of legislation or other regulatory developments affecting us or our industry; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● sales of our common stock by us, our insiders or our other stockholders; ● speculation in the press or investment community; ● announcement or expectation of additional financing efforts; ● changes in accounting principles; ● terrorist acts, acts of war or periods of widespread civil unrest; ● natural disasters and other calamities; ● changes in market conditions for biopharmaceutical stocks; and ● changes in general market and economic conditions.
The market price of shares of our common stock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: ● results of clinical trials of our product candidates; ● the timing of the release of results of our clinical trials; ● results of clinical trials of our competitors’ products; ● safety issues with respect to our products or our competitors’ products; ● regulatory actions with respect to our products or our competitors’ products; ● actual or anticipated fluctuations in our financial condition and operating results; ● publication of research reports by securities analysts about us or our competitors or our industry; ● our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; ● additions and departures of key personnel; ● strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; ● the passage of legislation or other regulatory developments affecting us or our industry; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● sales of our common stock by us, our insiders or our other stockholders; ● speculation in the press or investment community; ● announcement or expectation of additional financing efforts; ● changes in accounting principles; ● terrorist acts, acts of war or periods of widespread civil unrest; ● natural disasters and other calamities; ● changes in market conditions for biopharmaceutical stocks; and 88 ● changes in general market and economic conditions.
The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including but not limited to: ● an inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical trials; ● delays in reaching a consensus with regulatory agencies on trial design; and ● the FDA or foreign regulatory authorities not permitting the reliance on preclinical or other data from published scientific literature.
The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including but not limited to: 45 ● an inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical trials; ● delays in reaching a consensus with regulatory agencies on trial design; and ● the FDA or foreign regulatory authorities not permitting the reliance on preclinical or other data from published scientific literature.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients; ● the number and location of participating clinical sites or patients; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; ● the availability of competing commercially available therapies and other competing drug candidates’ clinical trials; 57 ● our ability to obtain and maintain patient informed consents for participation in our clinical trials; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients; ● the number and location of participating clinical sites or patients; ● the design of the trial; 49 ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; ● the availability of competing commercially available therapies and other competing drug candidates’ clinical trials; ● our ability to obtain and maintain patient informed consents for participation in our clinical trials; and ● the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.
If our common stock is deemed “penny stock”, because of penny stock rules, there may be less trading activity in any market that develops for our common stock in the future and stockholders are likely to have difficulty selling their shares. 98 FINRA sales practice requirements may limit a stockholder ’ s ability to buy and sell our common stock.
If our common stock is deemed “penny stock”, because of penny stock rules, there may be less trading activity in any market that develops for our common stock in the future and stockholders are likely to have difficulty selling their shares. FINRA sales practice requirements may limit a stockholder ’ s ability to buy and sell our common stock.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials. 96 Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. We are subject to the periodic reporting requirements of the Exchange Act.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials. Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. We are subject to the periodic reporting requirements of the Exchange Act.
In addition, if one or more of our product candidates or our antibody therapeutic development approach generally prove to be unsafe, our entire technology platform and pipeline could be affected, which would also materially harm our business. 56 As an organization, we have limited experience designing and implementing clinical trials and we have never conducted pivotal clinical trials.
In addition, if one or more of our product candidates or our antibody therapeutic development approach generally prove to be unsafe, our entire technology platform and pipeline could be affected, which would also materially harm our business. As an organization, we have limited experience designing and implementing clinical trials and we have never conducted pivotal clinical trials.
Any of these relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.
Any of these relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. 78 We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.
Dollars and Euros in cash at a non-sanctioned governmental bank. While this has been an adequate course of action to proceed in compliance, there is no guarantee it will remain so. We may not be able to protect our intellectual property rights throughout the world.
Dollars and Euros in cash at a non-sanctioned governmental bank. While this has been an adequate course of action to proceed in compliance, there is no guarantee it will remain so. 66 We may not be able to protect our intellectual property rights throughout the world.
Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all.
Even if we are able to generate revenue from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations. 39 We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all.
Significant clinical trial delays could also allow our competitors to bring products to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates. 52 Any such events would impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
Significant clinical trial delays could also allow our competitors to bring products to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates. Any such events would impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.
However, these security measures may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. 80 Adequate remedies may not exist in the event of unauthorized use or disclosure of our proprietary information.
However, these security measures may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Adequate remedies may not exist in the event of unauthorized use or disclosure of our proprietary information.
In addition, if the FDA or a comparable foreign regulatory authority approves a product candidate, the manufacturing processes, labeling, packaging, distribution, tracking and tracing event and deviation reporting, storage, advertising, promotion, import and export and record keeping for the product candidate will be subject to extensive and ongoing regulatory requirements.
In addition, if the FDA or a comparable foreign regulatory authority approves a product candidate, the manufacturing processes, labeling, packaging, distribution, tracking and tracing, adverse event and deviation reporting, storage, advertising, promotion, import and export and record keeping for the product candidate will be subject to extensive and ongoing regulatory requirements.
Later discovery of previously unknown problems with any approved candidate, including adverse events of unanticipated severity or frequency, or with our or our third-party manufacturers’ manufacturing processes or facilities, or failure to comply with regulatory requirements, may result in, among other things: 63 ● suspension of, or imposition of restrictions on, the marketing or manufacturing of the product, withdrawal of the product from the market, or product recalls; ● Warning Letters or Untitled Letters, or holds on clinical trials; ● refusal by the FDA to approve pending applications or supplements to approved applications we file, or suspension or revocation of approved biologics licenses; ● product seizure or detention, monetary penalties, refusal to permit the import or export of the product, or placement on Import Alert; and ● permanent injunctions and consent decrees including the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with any approved candidate, including adverse events of unanticipated severity or frequency, or with our or our third-party manufacturers’ manufacturing processes or facilities, or failure to comply with regulatory requirements, may result in, among other things: 55 ● suspension of, or imposition of restrictions on, the marketing or manufacturing of the product, withdrawal of the product from the market, or product recalls; ● Warning Letters or Untitled Letters, or holds on clinical trials; ● refusal by the FDA to approve pending applications or supplements to approved applications we file, or suspension or revocation of approved biologics licenses; ● product seizure or detention, monetary penalties, refusal to permit the import or export of the product, or placement on Import Alert; and ● permanent injunctions and consent decrees including the imposition of civil or criminal penalties.
In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. 66 We may also submit marketing applications in other countries.
In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. We may also submit marketing applications in other countries.
If we do not compete successfully, we may not generate or derive sufficient revenue from any product candidate for which we obtain marketing approval and may not become or remain profitable. 90 We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
If we do not compete successfully, we may not generate or derive sufficient revenue from any product candidate for which we obtain marketing approval and may not become or remain profitable. We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
Pending their use, we may invest our cash resources in a manner that does not produce income or loses value. 91 We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Pending their use, we may invest our cash resources in a manner that does not produce income or loses value. We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. 95 Our business is heavily regulated and therefore involves significant interaction with public officials.
Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. Our business is heavily regulated and therefore involves significant interaction with public officials.
Clinical trials may be suspended by the FDA, other foreign regulatory authorities, us, or by an IRB or ethics committee with respect to a particular clinical trial site, for various reasons, including: ● deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or trial protocols; ● deficiencies in the clinical trial operations or trial sites; ● unforeseen adverse side effects or the emergence of undue risks to trial subjects; ● deficiencies in the trial design necessary to demonstrate efficacy; ● the product candidate may not appear to offer benefits over current therapies; or ● the quality or stability of the product candidate may fall below acceptable standards. 62 We intend to develop our product candidates in part in combination with other therapies and may develop our future product candidates in combination with other therapies, which exposes us to additional regulatory risks.
Clinical trials may be suspended by the FDA, other foreign regulatory authorities, us, or by an IRB or ethics committee with respect to a particular clinical trial site, for various reasons, including: ● deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or trial protocols; ● deficiencies in the clinical trial operations or trial sites; ● unforeseen adverse side effects or the emergence of undue risks to trial subjects; ● deficiencies in the trial design necessary to demonstrate efficacy; ● the product candidate may not appear to offer benefits over current therapies; or ● the quality or stability of the product candidate may fall below acceptable standards. 54 We intend to develop our product candidates in part in combination with other therapies and may develop our future product candidates in combination with other therapies, which exposes us to additional regulatory risks.
See the section titled, “Business — Government Regulation — Other Healthcare Laws and Compliance Requirements”. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
See the section titled, “Business — Government Regulation — Other Healthcare Laws and Compliance Requirements”. 62 It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 77 In addition, many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. In addition, many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
The degree of market acceptance of our current and any future product candidates, if approved for commercial sale, will depend on a number of factors, including: ● efficacy and potential advantages compared to alternative treatments, including those that are not yet approved; ● the ability to offer our products, if approved, for sale at competitive prices; 65 ● 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, sales and distribution support; ● the ability to obtain sufficient third-party coverage and adequate reimbursement, including with respect to the use of the approved product as a combination therapy; and ● the prevalence and severity of any side effects.
The degree of market acceptance of our current and any future product candidates, if approved for commercial sale, will depend on a number of factors, including: 57 ● efficacy and potential advantages compared to alternative treatments, including those that are not yet approved; ● the ability to offer our products, if approved, for sale at competitive prices; ● 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, sales and distribution support; ● the ability to obtain sufficient third-party coverage and adequate reimbursement, including with respect to the use of the approved product as a combination therapy; and ● the prevalence and severity of any side effects.
If we are not able to generate sufficient revenue through the sale of any current or future product candidate, we may not be able to continue our business operations or achieve profitability. 50 Clinical development involves a lengthy and expensive process with uncertain outcomes.
If we are not able to generate sufficient revenue through the sale of any current or future product candidate, we may not be able to continue our business operations or achieve profitability. Clinical development involves a lengthy and expensive process with uncertain outcomes.
As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights. 58 Our clinical trials may be conducted in overseas jurisdictions, which may subject us to delays and expenses.
As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights. 50 Our clinical trials may be conducted in overseas jurisdictions, which may subject us to delays and expenses.
If our CDMOs were to encounter any of these difficulties, our ability to provide our product candidate to patients in clinical trials, or to provide product for the treatment of patients once approved, would be jeopardized. Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
If our CDMOs were to encounter any of these difficulties, our ability to provide our product candidate to patients in clinical trials, or to provide product for the treatment of patients once approved, would be jeopardized. 63 Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. 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 share price may be more volatile.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. 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.
Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in, and progress of, our development activities, acquisitions of additional product candidates and changes in regulation. 47 If we raise additional capital through marketing, sales and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, future revenue streams or research programs, technologies or grant licenses on terms that may not be favorable to us.
Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in, and progress of, our development activities, acquisitions of additional product candidates and changes in regulation. 40 If we raise additional capital through marketing, sales and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, future revenue streams or research programs, technologies or grant licenses on terms that may not be favorable to us.
We will be required to implement these new safeguards when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost. 86 The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
We will be required to implement these new safeguards when conducting restricted data transfers under the GDPR and doing so will require significant effort and cost. 76 The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects. Risks Related to Information Technology and Data Privacy We depend on our information technology systems, and any failure of these systems could harm our business.
Should any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects. 73 Risks Related to Information Technology and Data Privacy We depend on our information technology systems, and any failure of these systems could harm our business.
If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting once that firm begin its Section 404 reviews, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities.
If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting once that firm begin its Section 404 audits, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities.
As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA or other regulatory approval or discovering, developing and commercializing products in our field before we do, which could result in our competitors establishing a strong market position before we are able to enter the market. 89 Our competitors may obtain FDA or other regulatory approval of their product candidates more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates or platform technologies.
As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA or other regulatory approval or discovering, developing and commercializing products in our field before we do, which could result in our competitors establishing a strong market position before we are able to enter the market. 79 Our competitors may obtain FDA or other regulatory approval of their product candidates more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates or platform technologies.
The FDA or comparable foreign regulatory authorities also may approve any of our product candidates for a more limited indication or a narrower patient population than we originally requested, and the FDA or comparable foreign regulatory authorities may not approve any of our product candidates with the labeling that we believe is necessary or desirable for the successful commercialization of any such product candidates. 61 Of the large number of biopharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’ approval processes and are commercialized.
The FDA or comparable foreign regulatory authorities also may approve any of our product candidates for a more limited indication or a narrower patient population than we originally requested, and the FDA or comparable foreign regulatory authorities may not approve any of our product candidates with the labeling that we believe is necessary or desirable for the successful commercialization of any such product candidates. 53 Of the large number of biopharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’ approval processes and are commercialized.
In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability. 64 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 regulatory approval.
In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability. 56 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 regulatory approval.
As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable product candidate, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. 87 We may depend on other third-party collaborators for the discovery, development and commercialization of certain of our current and future product candidates.
As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable product candidate, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. 77 We may depend on other third-party collaborators for the discovery, development and commercialization of certain of our current and future product candidates.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects. 79 Others may claim an ownership interest in our intellectual property and our product candidates, which could expose us to litigation and have a significant adverse effect on our prospects.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business, financial condition, results of operations and prospects. 70 Others may claim an ownership interest in our intellectual property and our product candidates, which could expose us to litigation and have a significant adverse effect on our prospects.
If we do not establish marketing, sales and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates. 67 Risks Related to Healthcare, Insurance and Legal Matters Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
If we do not establish marketing, sales and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates. 59 Risks Related to Healthcare, Insurance and Legal Matters Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
See the section entitled, “Business — Government Regulation — Pharmaceutical Coverage, Pricing and Reimbursement”. 68 Our ability to successfully commercialize our product candidates, whether as a single agent or combination therapy, will depend in part on the extent to which coverage and adequate reimbursement for our products and related treatments will be available from third-party payors.
See the section entitled, “Business — Government Regulation — Pharmaceutical Coverage, Pricing and Reimbursement”. 60 Our ability to successfully commercialize our product candidates, whether as a single agent or combination therapy, will depend in part on the extent to which coverage and adequate reimbursement for our products and related treatments will be available from third-party payors.
Although we have determined that our internal control over financial reporting was effective as of December 31, 2024, we cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future.
Although we have determined that our internal control over financial reporting was effective as of December 31, 2025, we cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future.
Our current and future product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or 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 or comparable foreign regulatory authorities that a product candidate has an acceptable risk-benefit profile in the proposed indication; 59 ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that the facility in which a product candidate is manufactured meets standards designed to assure that the product candidate continues to be safe, pure, and potent; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies; ● the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA to the FDA or regulatory submissions to comparable regulatory authorities to obtain regulatory approval in such jurisdiction; and ● the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve our manufacturing processes or facility or the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies.
It is possible that none of our current or future product candidates will ever obtain regulatory approval from the FDA or comparable foreign regulatory authorities. 51 Our current and future product candidates could fail to receive regulatory approval for many reasons, including the following: ● the FDA or 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 or comparable foreign regulatory authorities that a product candidate has an acceptable risk-benefit profile in the proposed indication; ● we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that the facility in which a product candidate is manufactured meets standards designed to assure that the product candidate continues to be safe, pure, and potent; ● the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; ● we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies; ● the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA to the FDA or regulatory submissions to comparable regulatory authorities to obtain regulatory approval in such jurisdiction; and ● the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve our manufacturing processes or facility or the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies.
Our ability to generate future revenue from product sales depends heavily on our, or our existing or future collaborators’, success in: ● completing preclinical studies and clinical trials of our product candidates; ● seeking and obtaining marketing approvals for any product candidates that we or our collaborators develop; ● identifying and developing new product candidates; ● launching and commercializing product candidates for which we obtain marketing approval by establishing a marketing, sales, distribution and medical affairs infrastructure or, alternatively, collaborating with a commercialization partner; ● achieving coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and Medicaid, private insurers and managed care organizations, for product candidates, if approved, that we or our collaborators develop; ● obtaining market acceptance of product candidates, if approved, that we develop as viable treatment options; ● addressing any competing technological and market developments; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements; ● maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; ● defending against third-party interference or infringement claims, if any; and ● attracting, hiring and retaining qualified personnel. 46 We anticipate incurring significant costs associated with commercializing any product candidate that is approved for commercial sale.
Our ability to generate future revenue from product sales depends heavily on our, or our existing or future collaborators’, success in: ● completing preclinical studies and clinical trials of our product candidates; ● seeking and obtaining marketing approvals for any product candidates that we or our collaborators develop; ● identifying and developing new product candidates; ● launching and commercializing product candidates for which we obtain marketing approval by establishing a marketing, sales, distribution and medical affairs infrastructure or, alternatively, collaborating with a commercialization partner; ● achieving coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and Medicaid, private insurers and managed care organizations, for product candidates, if approved, that we or our collaborators develop; ● obtaining market acceptance of product candidates, if approved, that we develop as viable treatment options; ● addressing any competing technological and market developments; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements; ● maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; ● defending against third-party interference or infringement claims, if any; and ● attracting, hiring and retaining qualified personnel.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. 86 We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative effect on the marketing approval process in others.
Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining and maintaining marketing approval of our current and future product candidates in other jurisdictions. 58 Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative effect on the marketing approval process in others.
We are early in our development efforts. Our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of our current products or future product candidates we develop, which may never occur.
Our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of our current products or future product candidates we develop, which may never occur.
We anticipate that our expenses will increase substantially if, and as, we: ● continue to advance the preclinical and clinical development of our existing product candidates and our research programs; ● leverage our research and development capabilities, including our proprietary StitchMabs TM technology, to advance additional product candidates into preclinical and clinical development; ● seek regulatory approvals for any product candidates that successfully complete clinical trials; ● hire additional clinical, quality control, regulatory, scientific and administrative personnel; ● expand our operational, financial and management systems and increase personnel, including to support our clinical development and our operations as a public company; ● maintain, expand and protect our intellectual property portfolio; ● establish a marketing, sales, distribution and medical affairs infrastructure to commercialize any products for which we may obtain marketing approval and commercialize, whether on our own or jointly with a partner; ● acquire or in-license other technologies or engage in strategic partnerships; and 45 ● incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company.
We anticipate that our expenses will increase substantially if, and as, we: ● continue to advance the preclinical and clinical development of our existing product candidates and our research programs; ● leverage our research and development capabilities, including our proprietary StitchMabs TM technology, to advance additional product candidates into preclinical and clinical development; ● seek regulatory approvals for any product candidates that successfully complete clinical trials; ● hire additional clinical, quality control, regulatory, scientific and administrative personnel; ● expand our operational, financial and management systems and increase personnel, including to support our clinical development and our operations as a public company; ● maintain, expand and protect our intellectual property portfolio; ● establish a marketing, sales, distribution and medical affairs infrastructure to commercialize any products for which we may obtain marketing approval and commercialize, whether on our own or jointly with a partner; ● acquire or in-license other technologies or engage in strategic partnerships; and ● incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company. 38 To become and remain profitable, we must develop and eventually commercialize products with significant market potential.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products. In addition, the patent positions of companies in the development and commercialization of biological products and pharmaceuticals are particularly uncertain. Recent rulings from the U.S.
In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products. 68 In addition, the patent positions of companies in the development and commercialization of biological products and pharmaceuticals are particularly uncertain.
We may continue to be a “smaller reporting company” until (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of the prior June 30.
We will continue to be a “smaller reporting company” until (i) the market value of our stock held by non-affiliates is more than $700 million or (ii) our annual revenue is more than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is more than $250 million as of the prior June 30.
We are a clinical-stage biopharmaceutical company with a limited operating history. Since our founding in 2014, we have incurred significant net losses with an accumulated deficit of $365 million as of December 31, 2024.
We are a clinical-stage biopharmaceutical company with a limited operating history. Since our founding in 2014, we have incurred significant net losses with an accumulated deficit of $431 million as of December 31, 2025.
Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.
Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. 78 If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. 67 If we do not obtain patent term extension and data exclusivity for our product candidates, our business may be materially harmed.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year.
We are a smaller reporting company, meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue is less than $100 million during the most recently completed fiscal year.
Currently, federal agencies in the United States are operating under a continuing resolution that is set to expire on March 14, 2025. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted.
Currently, federal agencies in the United States are operating under a continuing resolution that is set to expire on September 30, 2026. Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted.
We and our licensors have sought, and intend to seek, to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates and technology that are important to our business. No patent has yet issued from our patent applications.
We and our licensors have sought, and intend to seek, to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates and technology that are important to our business.
As such it is difficult to accurately predict the developmental challenges we may incur for our product candidates as they proceed through product discovery or identification, preclinical studies and clinical trials.
Our bispecific and monoclonal antibody technology is relatively new. As such it is difficult to accurately predict the developmental challenges we may incur for our product candidates as they proceed through product discovery or identification, preclinical studies and clinical trials.
In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents.
Such a loss of patent protection could have a material adverse impact on our business. 69 In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents.
If these FINRA requirements are applicable to us or our securities, they may make it more difficult for broker-dealers to recommend that at least some of their customers buy our common stock, which may limit the ability of our stockholders to buy and sell our common stock and could have an adverse effect on the market for and price of our common stock.
If these FINRA requirements are applicable to us or our securities, they may make it more difficult for broker-dealers to recommend that at least some of their customers buy our common stock, which may limit the ability of our stockholders to buy and sell our common stock and could have an adverse effect on the market for and price of our common stock. 87 The market price of our common stock may be highly volatile, and may be influenced by numerous factors, some of which are beyond our control.
We have funded our operations to date primarily with proceeds from private placements of preferred and common equity, an underwritten public offering and a PIPE offering, as well as sales under our at-the-market offering program pursuant to an Open Market Sale Agreement SM with Jefferies LLC.
We have funded our operations to date primarily with proceeds from private placements of preferred and common equity, an underwritten public offering and a PIPE offering, as well as sales under our at-the-market offering program.
Court of Appeals for the Federal Circuit and the U.S. Supreme Court have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents. Depending on future actions by the U.S.
Recent rulings from the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents.
Moreover, increasing efforts by governmental and other third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates.
See the section titled, “Business — Government Regulation — Current and future healthcare reform legislation”. 61 Moreover, increasing efforts by governmental and other third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates.
For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.
For example, over the last several years, including for 43 days beginning on October 1, 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.
As of December 31, 2024, we had $126.7 million in cash, cash equivalents and marketable securities. Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027.
As of December 31, 2025, we had $209 million in cash, cash equivalents and marketable securities. Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditure requirements into 2028.
We do not anticipate that we will pay any cash dividends to holders of our common stock in the foreseeable future. Instead, we plan to retain any earnings to maintain and expand our operations.
You should not rely on an investment in our common stock to provide dividend income. We do not anticipate that we will pay any cash dividends to holders of our common stock in the foreseeable future. Instead, we plan to retain any earnings to maintain and expand our operations.
We may then be forced to seek a license from the third party that may not be available on commercially favorable terms, or at all. 73 The patent prosecution process is expensive, time consuming and complex, and we may not have and may not in the future be able to file, prosecute, maintain, enforce, defend or license all necessary or desirable patent applications in some or all relevant jurisdictions at a reasonable cost or in a timely manner.
The patent prosecution process is expensive, time consuming and complex, and we may not have and may not in the future be able to file, prosecute, maintain, enforce, defend or license all necessary or desirable patent applications in some or all relevant jurisdictions at a reasonable cost or in a timely manner.
In such an event, potential competitors might be able to enter the market and this circumstance could have a material adverse effect on our business. 74 On February 1, 2019 the government of Venezuela, in response to certain U.S. sanctions, began to require that foreign entities pay all official fees, including patent fees (either for pending matters or new petitions), in PETRO, a “cryptocurrency” created by the Nicolás Maduro administration in February 2018 as a way to collect U.S. dollars while avoiding American financial sanctions issued under an Executive Order of then-President Trump on March 19, 2018.
On February 1, 2019 the government of Venezuela, in response to certain U.S. sanctions, began to require that foreign entities pay all official fees, including patent fees (either for pending matters or new petitions), in PETRO, a “cryptocurrency” created by the Nicolás Maduro administration in February 2018 as a way to collect U.S. dollars while avoiding American financial sanctions issued under an Executive Order of then-President Trump on March 19, 2018.
If we are unable to obtain patent term extension or the scope of term of any such extension is less than we request, the period during which we will have the right to exclusively market our product may be shortened and our competitors may obtain approval of competing products following our patent expiration, and our revenue could be materially reduced. 76 Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
If we are unable to obtain patent term extension or the scope of term of any such extension is less than we request, the period during which we will have the right to exclusively market our product may be shortened and our competitors may obtain approval of competing products following our patent expiration, and our revenue could be materially reduced.
To become and remain profitable, we must develop and eventually commercialize products with significant market potential. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing, marketing and selling products and satisfying any post-marketing requirements.
This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing, marketing and selling products and satisfying any post-marketing requirements.
For example, our current or future product candidates may demonstrate different chemical, biological and pharmacological properties in patients than they do in laboratory studies or may interact with human biological systems in unforeseen or harmful ways.
In addition, the results of our preclinical studies may not be predictive of the results of outcomes in human clinical trials. For example, our current or future product candidates may demonstrate different chemical, biological and pharmacological properties in patients than they do in laboratory studies or may interact with human biological systems in unforeseen or harmful ways.
In December 2024, the U.S. Department of Justice issued regulations implementing Executive Order (“EO”) 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United Stated Government-Related Data by Countries of Concern,” which are expected to become effective in April 2025.
In December 2024, the U.S. Department of Justice issued regulations implementing Executive Order (“EO”) 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United Stated Government-Related Data by Countries of Concern,” which became effective in April 2025. These regulations prohibit transactions involving access to bulk sensitive data by countries of concern, such as China (including Hong Kong).
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations. 81 Collaborations with third parties, including academic collaborations, may limit our ability to obtain, maintain, enforce or defend intellectual property necessary to conduct our business.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations.
To gain approval to market our product candidates in the United States, we must provide the FDA with clinical data that adequately demonstrate the safety, purity and potency, including efficacy, of the product candidate for the proposed indication or indications in a BLA submission.
The denial or delay of any such approval would prevent or delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations. 52 To gain approval to market our product candidates in the United States, we must provide the FDA with clinical data that adequately demonstrate the safety, purity and potency, including efficacy, of the product candidate for the proposed indication or indications in a BLA submission.
The advancement of our product candidates and development programs and the potential commercialization of our current and future product candidates will require substantial additional cash to fund expenses. For some of our current or future product candidates, we may decide to collaborate with pharmaceutical and biotechnology companies with respect to development and potential commercialization.
For some of our current or future product candidates, we may decide to collaborate with pharmaceutical and biotechnology companies with respect to development and potential commercialization.
In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.
Neither we nor any future collaborator is permitted to market any biological product in the United States until we or the future collaborator receives regulatory approval of a biologics license application ("BLA"), from the FDA. It is possible that none of our current or future product candidates will ever obtain regulatory approval from the FDA or comparable foreign regulatory authorities.
Neither we nor any future collaborator is permitted to market any biological product in the United States until we or the future collaborator receives regulatory approval of a biologics license application ("BLA"), from the FDA.
If the FDA or a comparable foreign regulatory authority finds our facilities or those of our CDMOs inadequate for the manufacture of our product candidates or if such facilities are subject to enforcement action in the future or are otherwise inadequate, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates. 71 Additionally, our CDMOs may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments or on account of global pandemics or similar events.
If the FDA or a comparable foreign regulatory authority finds our facilities or those of our CDMOs inadequate for the manufacture of our product candidates or if such facilities are subject to enforcement action in the future or are otherwise inadequate, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have implemented and maintain a security risk management program that is designed to preserve the confidentiality, integrity, and continued availability of information under our ownership or care with the aim to continually improve security features in order to keep pace with the evolving cyber threat landscape. 100 We face a number of cybersecurity risks in connection with our business and recognize the growing threat within the general marketplace and our industry.
Biggest changeWe have implemented and maintain a security risk management program that is designed to preserve the confidentiality, integrity, and continued availability of information under our ownership or care with the aim to continually improve security features in order to keep pace with the evolving cyber threat landscape.
The Director of IT role is currently held by an individual who has more than 20 years of professional IT management experience and maintains a Global Information Assurance Certification. The Director of IT reports to our Chief Accounting Officer, who together are responsible for coordinating information security risk assessments and overseeing periodic testing of our cybersecurity controls.
The Head of IT role is currently held by an individual who has more than 20 years of professional IT management experience and maintains a Global Information Assurance Certification. The Head of IT reports to our Chief Accounting Officer, who together are responsible for coordinating information security risk assessments and overseeing periodic testing of our cybersecurity controls.
These assessments are overseen by our Director of IT and Chief Accounting Officer. We implement cybersecurity controls and procedures designed to address cyber risks and threats, supported by third-party technologies and security advisors and providers. We also provide cybersecurity awareness training to our employees during the onboarding process and periodically thereafter.
These assessments are overseen by our Head of IT and Chief Accounting Officer. We implement cybersecurity controls and procedures designed to address cyber risks and threats, supported by third-party technologies and security advisors and providers. We also provide cybersecurity awareness training to our employees during the onboarding process and periodically thereafter.
In addition, we engage external third-party information security consultants to periodically conduct information security testing and assessments, and to evaluate our overarching information security program and specific incident response procedures. We also maintain a Cyber Incident Response Plan, which is overseen by our Director of IT and is designed to coordinate our response to information security incidents.
In addition, we engage external third-party information security consultants to periodically conduct information security testing and assessments, and to evaluate our overarching information security program and specific incident response procedures. We also maintain a Cyber Incident Response Plan, which is overseen by our Head of IT and is designed to coordinate our response to information security incidents.
We have implemented a process for the Director of IT and the Chief Accounting Officer to receive incident reports and report quarterly (and, if applicable, in the event of a cybersecurity incident), to our internal disclosure committee and the audit committee, as appropriate.
We have implemented a process for the Head of IT and the Chief Accounting Officer to receive incident reports and report quarterly (and, if applicable, in the event of a cybersecurity incident), to our internal disclosure committee and the audit committee, as appropriate.
Finally, we hold and maintain third-party insurance coverage for cybersecurity risks commensurate with industry standards for a company of our size and stage. Cybersecurity Oversight The Director of IT is responsible for implementing and maintaining the information security program.
Finally, we hold and maintain third-party insurance coverage for cybersecurity risks commensurate with industry standards for a company of our size and stage. 89 Cybersecurity Oversight The Head of IT is responsible for implementing and maintaining the information security program.
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We face a number of cybersecurity risks in connection with our business and recognize the growing threat within the general marketplace and our industry.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn September 2024, we signed a new lease on our existing facility, effective May 2025, extending the term six years to May 2031 and expanding the space to 29,836 square feet. We believe that these facilities are adequate for our current needs and that suitable additional or substitute space will be available in the future if needed.
Biggest changeWe believe that these facilities are adequate for our current needs and that suitable additional or substitute space will be available in the future if needed.
Item 2. Properties. Our corporate headquarters is located at 80 Guest Street, Boston, Massachusetts, and consists of 19,112 square feet of office space and laboratory space pursuant to a sublease agreement that expires in May 2025.
Item 2. Properties. Our corporate headquarters is located at 80 Guest Street, Boston, Massachusetts, and consists of 29,836 square feet of office space and laboratory space pursuant to a lease agreement that expires in May 2031.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeMine Safety Disclosures. Not applicable. 101 PART II
Biggest changeMine Safety Disclosures. Not applicable. 90 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThis value is not included in the weighted average exercise price. On January 1, 2025, an additional 5.5 million shares became available for issuance for a total of 6.9 million shares available for future issuance. For further description of the equity compensation plans, see Note 9 to the consolidated financial statements included in this Annual Report on Form 10-K.
Biggest changeFor further description of the equity compensation plans, see Note 9 to the consolidated financial statements included in this Annual Report on Form 10-K. Item 6. [Reserved]. 91
As of February 20, 2025, there were approximately 100 stockholders of record of our common stock. The actual number of stockholders is greater than this number and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
As of February 20, 2026, there were approximately 90 stockholders of record of our common stock. The actual number of stockholders is greater than this number and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
The following table presents information as of December 31, 2024 with respect to compensation plans or arrangements under which shares of our common stock may be issued: Plan category Number of securities to be issued upon exercise of outstanding stock options, warrants and rights (000's) Weighted-average exercise price of outstanding stock options, warrants and rights Number of securities remaining available for issuance under equity compensation plans (000's) Equity compensation plans approved by security holders 17,828 (1) $ 2.83 (1) 1,418 Equity compensation plans not approved by security holders — — — Total 17,828 $ 2.83 1,418 (1) Includes 3.8 million shares of common stock issuable (subject to vesting) with respect to restricted stock units granted pursuant to the 2020 Plan; 675 thousand at a grant date fair market value of $3.93 per share, 300 thousand at a grant date fair market value of $3.83 per share, 400 thousand at a grant date fair market value of $1.65 per share and 2.4 million at a grant date fair market value of $1.93 per share.
The following table presents information as of December 31, 2025 with respect to compensation plans or arrangements under which shares of our common stock may be issued: Plan category Number of securities to be issued upon exercise of outstanding stock options, warrants and rights (000's) Weighted-average exercise price of outstanding stock options, warrants and rights Number of securities remaining available for issuance under equity compensation plans (000's) Equity compensation plans approved by security holders 17,380 (1) $ 3.13 (1) 5,265 Equity compensation plans not approved by security holders — — 4,000 Total 17,380 $ 3.13 9,265 (1) Includes 1.0 million shares of common stock issuable (subject to vesting) with respect to restricted stock units granted pursuant to the 2020 Plan; 250 thousand at a grant date fair market value of $3.93 per share, 300 thousand at a grant date fair market value of $1.65 per share and 478 thousand at a grant date fair market value of $1.93 per share.
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In addition, in December 2025 our board of directors adopted the Compass Therapeutics, Inc. 2025 Inducement Plan (the “Inducement Plan”) to enable us to grant equity awards to induce highly-qualified prospective employees to accept employment.
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This value is not included in the weighted average exercise price. (2) In December 2025, we adopted the Compass Therapeutics, Inc. 2025 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4). There were no issues from this plan as of December 31, 2025.
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On January 1, 2026, a total of two million options were granted as part of the Inducement Plan to two new officers. On January 1, 2026, an additional 7.1 million shares became available for issuance for a total of 12.4 million shares available for future issuance under equity compensation plans approved by security holders.

Item 7. Management's Discussion & Analysis

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

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Biggest changeAs of December 31, 2024, we had cash, cash equivalents and marketable securities of $126.7 million. On July 9, 2021, we filed an S-3 registration statement which became effective July 20, 2021. Included in this registration statement was a shelf registration allowing us to sell securities up to $300 million.
Biggest changeOn July 9, 2021, we filed an S-3 registration statement which became effective July 20, 2021. Included in this registration statement was a shelf registration allowing us to sell securities up to $300 million. The Follow-On Public Offering was made pursuant to this registration statement. In addition, the S-3 registration statement included a sales agreement with B.
If we receive regulatory approval for our any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize our product candidates.
If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize our product candidates.
Our future funding requirements will depend on many factors, including, but not limited to: ● the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; ● the costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; ● the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates; ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; ● our ability to establish additional collaborations on favorable terms, if at all; ● the costs required to scale up our clinical, regulatory and manufacturing capabilities; ● the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and ● revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
Our future funding requirements will depend on many factors, including, but not limited to: 98 ● the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; ● the costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; ● the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates; ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; ● the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; ● our ability to establish additional collaborations on favorable terms, if at all; ● the costs required to scale up our clinical, regulatory and manufacturing capabilities; ● the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and ● revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
The timing and amount of our operating expenditures will depend largely on: ● the initiation, progress, timing, costs and results of clinical trials for our current product candidates or any future product candidates we may develop; ● the initiation, progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop; ● our ability to maintain our relationships with key collaborators; ● the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies or trials that had previously been agreed to; ● the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights; ● the effect of competing technological and market developments; ● the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space; ● market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors; ● the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; 111 ● the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing; ● the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize; and ● our need to implement additional internal systems and infrastructure, including financial and reporting systems.
The timing and amount of our operating expenditures will depend largely on: ● the initiation, progress, timing, costs and results of clinical trials for our current product candidates or any future product candidates we may develop; ● the initiation, progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop; ● our ability to maintain our relationships with key collaborators; ● the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies or trials that had previously been agreed to; ● the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights; ● the effect of competing technological and market developments; ● the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space; ● market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors; ● the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; ● the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing; 100 ● the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize; and ● our need to implement additional internal systems and infrastructure, including financial and reporting systems.
This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following: ● the timing and progress of nonclinical and clinical development activities; ● the number and scope of nonclinical and clinical programs we decide to pursue; ● raising necessary additional funds; ● the progress of the development efforts of parties with whom we may enter into collaboration arrangements; ● our ability to maintain our current development program and to establish new ones; ● our ability to establish new licensing or collaboration arrangements; ● the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; ● the receipt and related terms of regulatory approvals from applicable regulatory authorities; ● the availability of drug substance and drug product for use in production of our product candidate; ● establishing and maintaining agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidates are approved; ● our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally; ● our ability to protect our rights in our intellectual property portfolio; ● the commercialization of our product candidate, if and when approved; ● obtaining and maintaining third-party insurance coverage and adequate reimbursement; 106 ● the acceptance of our product candidate, if approved, by patients, the medical community and third-party payors; ● competition with other products; and ● a continued acceptable safety profile of our therapies following approval.
This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following: ● the timing and progress of nonclinical and clinical development activities; ● the number and scope of nonclinical and clinical programs we decide to pursue; ● raising necessary additional funds; ● the progress of the development efforts of parties with whom we may enter into collaboration arrangements; ● our ability to maintain our current development program and to establish new ones; ● our ability to establish new licensing or collaboration arrangements; ● the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; ● the receipt and related terms of regulatory approvals from applicable regulatory authorities; ● the availability of drug substance and drug product for use in production of our product candidate; ● establishing and maintaining agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidates are approved; 95 ● our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally; ● our ability to protect our rights in our intellectual property portfolio; ● the commercialization of our product candidate, if and when approved; ● obtaining and maintaining third-party insurance coverage and adequate reimbursement; ● the acceptance of our product candidate, if approved, by patients, the medical community and third-party payors; ● competition with other products; and ● a continued acceptable safety profile of our therapies following approval.
If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions. 103 Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions. 92 Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data.
We plan to advance our product candidates through clinical development and commercialization as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data.
Income tax expense We did not have income tax expense in 2024 or 2023. Liquidity and Capital Resources Since our inception, we have not generated any revenue from any product sales or any other sources, and we have incurred significant operating losses.
Income tax expense We did not have income tax expense in 2025 or 2024. Liquidity and Capital Resources Since our inception, we have not generated any revenue from any product sales or any other sources, and we have incurred significant operating losses.
We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company. Other income In 2024 and 2023, the only component of other income was interest income from marketable securities.
We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company. Other income In 2025 and 2024, the only component of other income was interest income from cash deposits and marketable securities.
We have funded our operations primarily with proceeds from the sale of equity securities of $430 million through December 31, 2024. We have incurred significant operating losses since inception. We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all.
We have funded our operations primarily with proceeds from the sale of equity securities of $568 million through December 31, 2025. We have incurred significant operating losses since inception. We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all.
On August 1, 2022, we entered into an Open Market Sale Agreement SM with Jefferies LLC, pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock.
On August 1, 2022, we entered into an Open Market Sale Agreement SM with Jefferies LLC, pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock, which has since been terminated.
We believe that our existing cash, cash equivalents and marketable securities as of December 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
We believe that our existing cash, cash equivalents and marketable securities as of December 31, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
We anticipate that our general and administrative expenses will increase in the future as we expand our operations to support our growing research and development efforts, as well as potential commercial operations. 108 Other income Other income consists only of interest income which decreased by $0.6 million from $7.9 million in 2023 to $7.3 million in 2024.
We anticipate that our general and administrative expenses will increase in the future as we expand our commercial operations and to support our growing research and development efforts. 97 Other income Other income consists only of interest income which decreased by $0.9 million from $7.3 million in 2024 to $6.4 million in 2025.
At-The-Market ( “ ATM ” ) Offering In the first quarter of 2024, we sold, through our Open Market Sale Agreement SM with Jefferies LLC, 9,790,577 shares of common stock at an average price of $1.85 for total proceeds of $18.1 million and net proceeds of $17.6 million.
In the first quarter of 2024, we sold, through our Jefferies ATM Agreement, 9,790,577 shares of common stock at an average price of $1.85 for total proceeds of $18.1 million and net proceeds of $17.6 million.
Stock Awards and Unit-Based Compensation The following table summarizes stock awards and unit-based compensation expense: Year Ended December 31, 2024 2023 (000's) Research and development $ 2,971 $ 1,998 General and administrative 5,589 4,122 Total $ 8,560 $ 6,120 See Notes 3 and 9 to our consolidated financial statements appearing in this Form 10-K for additional stock compensation information.
Stock Awards and Unit-Based Compensation The following table summarizes stock awards and unit-based compensation expense: Year Ended December 31, 2025 2024 (000's) Research and development $ 3,346 $ 2,971 General and administrative 5,022 5,589 Total $ 8,368 $ 8,560 See Notes 3 and 9 to our consolidated financial statements appearing in this Form 10-K for additional stock compensation information.
As of December 31, 2024 we recorded a deferred tax asset of $59.5 million primarily related to a net operating loss carryforward, section 174 capitalization, research and development tax credit carryforward, and capitalized licensing fees. The asset has a corresponding full deferred tax valuation allowance.
As of December 31, 2025 we recorded a deferred tax asset of $79.2 million primarily related to a net operating loss carryforward, section 174 capitalization, research and development tax credit carryforward, and capitalized licensing fees. The asset has a corresponding fully deferred tax valuation allowance.
There was no licensing revenue for the year ended December 31, 2023. The licensing revenue consisted of a $1 million milestone payment from Elpiscience for completing a Phase 1 trial in China.
Licensing revenue was $850 thousand for the year ended December 31, 2024. The licensing revenue consisted of a $1 million milestone payment from Elpiscience for completing a Phase 1 trial in China.
Our clinical development costs may vary significantly based on factors such as: ● per patient trial costs; ● the number of trials required for approval; ● the number of sites included in the trials; ● the location where the trials are conducted; 105 ● the length of time required to enroll eligible patients; ● the number of patients that participate in the trials; ● the number of doses that patients receive; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring requested by regulatory agencies; ● the duration of patient participation in the trials and follow-up; ● the cost and timing of manufacturing our product candidates; ● the phase of development of our product candidates; and ● the efficacy and safety profile of our product candidates.
At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates. 94 Our clinical development costs may vary significantly based on factors such as: ● per patient trial costs; ● the number of trials required for approval; ● the number of sites included in the trials; ● the location where the trials are conducted; ● the length of time required to enroll eligible patients; ● the number of patients that participate in the trials; ● the number of doses that patients receive; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring requested by regulatory agencies; ● the duration of patient participation in the trials and follow-up; ● the cost and timing of manufacturing our product candidates; ● the phase of development of our product candidates; and ● the efficacy and safety profile of our product candidates.
This license revenue is reported net of a 15% sublicense royalty due ABL Bio (see Note 10 of the consolidated financial statements appearing in this Form 10-K for further information on this sublicense agreement). Research and development expenses Research and development expenses increased by $4.2 million from $38.1 million in 2023 to $42.3 million in 2024.
This license revenue is reported net of a 15% sublicense royalty due to ABL Bio (see Note 11 of the consolidated financial statements appearing in this Form 10-K for further information on this sublicense agreement). Research and development expenses Research and development expenses increased by $13.6 million from $42.3 million in 2024 to $56.0 million in 2025.
This registration statement includes (i) a base prospectus that covers the offering, issuance and sale by us of up to $300,000,000 of our common stock, preferred stock, debt securities, warrants and/or units and (ii) a sale agreement prospectus supplement that covers the offer and sale, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $55 million pursuant to our Open Market Sale Agreement SM with Jefferies LLC. 109 Funding Requirements Our primary use of cash is to fund operating expenses, primarily research and development expenditures.
This registration statement includes (i) a base prospectus that covers the offering, issuance and sale by us of up to $300 million of our common stock, preferred stock, debt securities, warrants and/or units and (ii) a sale agreement prospectus supplement that covers the offer and sale, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $55 million pursuant to our Open Market Sale Agreement SM with Jefferies LLC.
As of December 31, 2024, we had $126.7 million in cash, cash equivalents and marketable securities. Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditures requirements into the first quarter of 2027.
As of December 31, 2025, we had $209 million in cash, cash equivalents and marketable securities. Based on our research and development plans, we expect that these cash resources will enable us to fund our operating expenses and capital expenditures requirements into 2028.
Our non-cash charges primarily consisted of stock-based compensation expense of $8.6 million. 110 During the year ended December 31, 2023, we used $40.6 million of cash in operating activities, resulting from our net loss of $42.5 million and the change in operating assets and liabilities of $2.9 million, offset by non-cash charges of $4.8 million.
Our non-cash charges primarily consisted of stock-based compensation expense of $8.4 million. During the year ended December 31, 2024, we used $44.9 million of cash in operating activities, resulting from our net loss of $49.4 million and the change in operating assets and liabilities of $4.1 million, offset by non-cash charges of $8.7 million.
Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2024 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods: Payments due by Period (000's) (3) Total Less than 1 year 1 to 3 years 3 to 5 years More than 5 years Operating lease commitments (1) $ 8,218 $ 733 $ 3,871 $ 2,977 $ 637 Manufacturing commitments (2) 2,550 2,550 — — — Total $ 10,768 $ 3,283 $ 3,871 $ 2,977 $ 637 (1) Reflects payments due for our leases of office and laboratory space in Boston, Massachusetts under an operating lease agreement that expires in May 2031.
Contractual Obligations and Commitments The following table summarizes our contractual obligations as of December 31, 2025 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods: Payments due by Period (000's) (2) Total Less than 1 year 1 to 3 years 3 to 5 years More than 5 years Operating lease commitments (1) $ 11,623 $ 1,525 $ 4,453 $ 4,650 $ 995 (1) Reflects payments due for our leases of office and laboratory space in Boston, Massachusetts under an operating lease agreement that expires in May 2031.
While our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements appearing in this Form 10-K, we believe that the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Our actual results may differ from these estimates under different assumptions or conditions. 101 While our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements appearing in this Form 10-K, we believe that the following accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
The IRA includes provisions imposing a 1% excise tax on share repurchases that occur after December 31, 2022 and introduces a 15% corporate alternative minimum tax on adjusted financial statement income.
The IRA includes provisions imposing a 1% excise tax on share repurchases that occur after December 31, 2022 and introduces a 15% corporate alternative minimum tax on adjusted financial statement income. To date, the IRA has not had a material impact on our consolidated financial statements.
Our net losses were $49.4 million and $42.5 million for the years ended December 31, 2024 and 2023, respectively, and as of December 31, 2024, we had an accumulated deficit of $365 million.
Our net losses were $66 million and $49 million for the years ended December 31, 2025 and 2024, respectively, and as of December 31, 2025, we had an accumulated deficit of $431 million.
This was primarily from the issuance of stock pursuant to our ATM program for net proceeds of $17.6 million. During the year ended December 31, 2023, cash provided by financing activities was $2.9 million. This was primarily from the issuance of stock pursuant to our ATM program for net proceeds of $3.0 million.
This was primarily from the issuance of stock through an underwritten stock offering for net proceeds of $129.4 million. During the year ended December 31, 2024, cash provided by financing activities was $17.3 million. This was primarily from the issuance of stock pursuant to our ATM program for net proceeds of $17.6 million.
Recently Issued and Adopted Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 3 to our consolidated financial statements appearing in this Annual Report. 113 JOBS Act In April 2012, the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act") was enacted.
Recently Issued and Adopted Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 3 to our consolidated financial statements appearing in this Annual Report.
Cash Flows The following table shows a summary of our cash flows for the periods indicated: Year ended December 31, 2024 2023 (000's) Cash used in operating activities $ (44,855 ) $ (40,618 ) Cash provided by investing activities 46,772 26,965 Cash provided by financing activities 17,338 2,935 Net increase (decrease) in cash and cash equivalents $ 19,255 $ (10,718 ) Operating Activities During the year ended December 31, 2024, we used $44.9 million of cash in operating activities, resulting from our net loss of $49.4 million and the change in operating assets and liabilities of $4.1 million, offset by non-cash charges of $8.7 million.
Cash Flows The following table shows a summary of our cash flows for the periods indicated: Year ended December 31, 2025 2024 (000's) Cash used in operating activities $ (49,143 ) $ (44,855 ) Cash (used in) provided by investing activities (93,306 ) 46,772 Cash provided by financing activities 129,609 17,338 Net (decrease) increase in cash and cash equivalents $ (12,840 ) $ 19,255 Operating Activities During the year ended December 31, 2025, we used $49.1 million of cash in operating activities, resulting from our net loss of $66.5 million and the change in operating assets and liabilities of $9.2 million and non-cash charges of $8.2 million.
During the year ended December 31, 2023 cash provided by investing activities was $27.0 million, which was primarily attributed to the net proceeds from the sale of marketable securities of $27.0 million. Financing Activities During the year ended December 31, 2024, cash provided by financing activities was $17.3 million.
During the year ended December 31, 2024, cash provided by investing activities was $46.8 million, which was primarily attributed to the net proceeds from the sale of marketable securities of $46.8 million. Financing Activities During the year ended December 31, 2025, cash provided by financing activities was $129.6 million.
(3) This table does not include (i) any milestone payments that are not deemed probable under license agreements as the timing and likelihood of such payments are not known with certainty, (ii) any royalty payments to third parties as the amounts, timing and likelihood of such payments are not known, and (iii) contracts that are entered into in the ordinary course of business which are cancelable. 112 Critical Accounting Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States ("GAAP").
(2) This table does not include (i) any milestone payments that are not deemed probable under license agreements as the timing and likelihood of such payments are not known with certainty, (ii) any royalty payments to third parties as the amounts, timing and likelihood of such payments are not known, and (iii) contracts that are entered into in the ordinary course of business which are cancelable.
The Follow-On Public Offering was made pursuant to this registration statement. In addition, the S-3 registration statement included a sales agreement with B. Riley Securities, Inc., pursuant to which we could offer and sell shares of our common stock having an aggregate of up to $75 million. We terminated the sales agreement with B. Riley effective July 29, 2022.
Riley Securities, Inc., pursuant to which we could offer and sell shares of our common stock having an aggregate of up to $75 million. We terminated the sales agreement with B. Riley effective July 29, 2022.
Our non-cash charges primarily consisted of stock-based compensation expense of $6.1 million. Investing Activities During the year ended December 31, 2024, cash provided by investing activities was $46.8 million, which was primarily attributed to the net proceeds from the sale of marketable securities of $46.8 million.
Our non-cash charges primarily consisted of stock-based compensation expense of $8.6 million. 99 Investing Activities During the year ended December 31, 2025, cash used in investing activities was $93.3 million, which was primarily attributed to the net purchases of marketable securities of $93.3 million.
To date, the IRA has not had a material impact on our consolidated financial statements. 104 Components of Results of Operations Research and development Research and development expenses consist primarily of costs incurred in connection with the development of our clinical product candidates, tovecimig, CTX-471 and CTX-8371, as well as unrelated preclinical and discovery program expenses.
Components of Results of Operations Research and development Research and development expenses consist primarily of costs incurred in connection with the development of our clinical product candidates, tovecimig, CTX-471, CTX-8371 and CTX-10726, as well as unrelated preclinical and discovery program expenses. We expense research and development costs as incurred.
This increase was primarily attributable to a $2.4 million increase in clinical and manufacturing costs related to our lead program, tovecimig, and $1.3 million from our second program, CTX-471, as described below. We track supplies, outsourced development, personnel costs and other research and development costs of specific programs. Facility and equipment costs are not allocated to programs.
This increase was primarily attributable to an increase of $14.2 million of manufacturing expenses related to tovecimig and CTX-10726. We track supplies, outsourced development, personnel costs and other research and development costs of specific programs. Facility and equipment costs are not allocated to programs.
See Note 13 to our consolidated financial statements appearing in this Form 10-K. 107 Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the results of operations for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 Change (000's) Licensing revenue $ 850 $ — $ 850 Operating expenses: Research and development 42,342 38,120 4,222 General and administrative 15,133 12,243 2,890 Total operating expenses 57,475 50,363 7,112 Loss from operations (56,625 ) (50,363 ) (7,112 ) Other income 7,250 7,869 (619 ) Net loss $ (49,375 ) $ (42,494 ) $ (7,731 ) Licensing revenue Licensing revenue was $850 thousand for the year ended December 31, 2024.
See Note 14 to our consolidated financial statements appearing in this Form 10-K. 96 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes the results of operations for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 Change (000's) Licensing revenue $ — $ 850 $ (850 ) Operating expenses: Research and development 55,969 42,342 13,627 General and administrative 16,870 15,133 1,737 Total operating expenses 72,839 57,475 15,364 Loss from operations (72,839 ) (56,625 ) (15,364 ) Other income 6,350 7,250 (900 ) Net loss $ (66,489 ) $ (49,375 ) $ (16,264 ) Licensing revenue There was no licensing revenue for the year ended December 31, 2025.
Research and development expenses are summarized by program in the table below: Year Ended December 31, 2024 2023 Change (000's) CTX-009 $ 27,938 $ 25,558 $ 2,380 CTX-471 4,863 3,575 1,288 CTX-8371 3,473 3,964 (491 ) Other research and development expenses 6,068 5,023 1,045 Total research and development expenses $ 42,342 $ 38,120 $ 4,222 General and administrative expenses General and administrative expenses increased by $2.9 million from $12.2 million in 2023 to $15.1 million in 2024.
Research and development expenses are summarized by program in the table below: Year Ended December 31, 2025 2024 Change (000's) tovecimig $ 25,259 $ 27,938 $ (2,679 ) CTX-471 8,248 4,863 3,385 CTX-8371 4,781 3,473 1,308 CTX-10726 10,216 — 10,216 Other research and development expenses 7,465 6,068 1,397 Total research and development expenses $ 55,969 $ 42,342 $ 13,627 General and administrative expenses General and administrative expenses increased by $1.7 million from $15.1 million in 2024 to $16.9 million in 2025.
We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. We have funded our operations primarily with proceeds from private placements of preferred and common equity and an underwritten public offering in the fourth quarter of 2021.
We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. We have funded our operations primarily with proceeds from multiple equity financings. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $209 million.
Removed
In the second quarter of 2023, we sold, through our Open Market Sale Agreement SM with Jefferies LLC, 951,873 shares of common stock at an average price of $3.28 for total proceeds of $3.1 million and net proceeds of $3.0 million. Inflation Reduction Act of 2022 The Inflation Reduction Act of 2022 (“IRA”) was enacted on August 16, 2022.
Added
At-The-Market ( “ ATM ” ) Offering In 2025, there were no issuances of common stock through our Open Market Sale Agreement SM with Jefferies LLC (“Jefferies ATM Agreement”). In December 2025, we entered into a Sales Agreement for our ATM offering with Leerink Partners LLC and Cantor Fitzgerald & Co and the prior Jefferies ATM Agreement was terminated.
Removed
We expense research and development costs as incurred.
Added
Underwritten Offering On August 12, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Piper Sandler & Co., and Guggenheim Securities, LLC, as representatives (the “Representatives”) of the underwriters named therein (the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of (a) 33,290,000 shares (the “Firm Shares”) of its common stock, par value $0.0001 per share (the “Common Stock”), at a price to the public of $3.00 per share, and (b) pre-funded warrants to purchase up to 6,710,000 shares of the Company’s Common Stock (the “Pre-Funded Warrants”), at a price to the public of $2.9999 per warrant with an exercise price of $0.0001 per share (the “Offering”).
Removed
At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates.
Added
Pursuant to the Underwriting Agreement, the Company granted the underwriters a 30-day option, which the underwriters exercised, to purchase up to an additional 6,000,000 shares of its Common Stock (the “Optional Shares”, and together with the Firm Shares, the “Shares”) at the public offering price, less underwriting discounts and commissions.
Removed
The increase was primarily attributable to higher personnel expense, including stock compensation of $2.3 million, driven by the CEO transition during the year.
Added
The Company received aggregate net proceeds of $129.3 million, after deducting underwriting discounts and commissions of $8.3 million and other offering costs of $0.4 million. 93 The 2025 Pre-Funded Warrants were determined to be equity classified.
Removed
Through December 31, 2024, we received gross proceeds of $430.5 million from the sale of equity securities, including $136.5 million in gross proceeds from our Follow-On Public Offering, $60.5 million in gross proceeds from the sale of our common stock in the Private Placement, $80.3 million in gross proceeds from a PIPE financing and $21.2 million in gross proceeds from sales through our ATM facility.
Added
Accordingly, proceeds from the offering were allocated to common stock, the 2025 Pre-Funded Warrants on a relative fair value basis and were recorded in stockholders’ equity. As of December 31, 2025, all of the 2025 Pre-Funded Warrants remain outstanding. Inflation Reduction Act of 2022 The Inflation Reduction Act of 2022 (“IRA”) was enacted on August 16, 2022.
Removed
(2) Amounts in the table reflect the non-cancelable purchase commitments under agreements with external CDMOs which we have engaged to manufacture clinical trial materials.
Added
The increase was primarily attributable to commercialization expenses of approximately $0.7 million and $0.5 million of advisory fees.
Removed
Our actual results may differ from these estimates under different assumptions or conditions.
Added
On December 30, 2025, we filed an S-3 registration statement which was declared effective by the SEC on January 7, 2026.
Removed
Under Section 107(b) of the JOBS Act, an “emerging growth company” can delay the adoption of new or revised accounting standards until such time as those standards would apply to private companies. We have made the election to delay the adoption of such accounting standards as provided in the JOBS Act.
Added
This registration statement includes (i) a base prospectus that covers the offering, issuance and sale by us of up to $400 million of our common stock, preferred stock, debt securities, warrants and/or units and (ii) a sale agreement prospectus supplement that covers the offer and sale, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100 million pursuant to our Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co.
Removed
There are other exemptions and reduced reporting requirements provided by the JOBS Act that we are currently evaluating.
Added
The prior Open Market Sale Agreement SM with Jefferies LLC was terminated as part of this filing. Funding Requirements Our primary use of cash is to fund operating expenses, primarily research and development expenditures.
Removed
For example, as an “emerging growth company”, we are exempt from Sections 14A(a) and (b) of the Exchange Act that would otherwise require us to (i) submit certain executive compensation matters to stockholder advisory votes, such as “say-on-pay”, “say-on-frequency”, and “golden parachutes”; and (ii) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of our Chief Executive Officer’s compensation to our median employee compensation.
Added
Critical Accounting Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States ("GAAP").
Removed
We also intend to rely on an exemption from the rule requiring us to provide an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.
Removed
We will continue to remain an “emerging growth company” until the earliest of the following: (i) the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement; (ii) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeChanges in the general level of interest rates can affect the fair value of our investment portfolio. If interest rates in the general economy were to change, our holdings could change as a result. 114
Biggest changeChanges in the general level of interest rates can affect the fair value of our investment portfolio. If interest rates in the general economy were to change, our holdings could change as a result. 102

Other CMPX 10-K year-over-year comparisons