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

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Paragraph-level year-over-year comparison of Dianthus Therapeutics, Inc. /DE/'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.

+370 added−314 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-11)

Top changes in Dianthus Therapeutics, Inc. /DE/'s 2025 10-K

370 paragraphs added · 314 removed · 278 edited across 7 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

180 edited+52 added−22 removed362 unchanged
Biggest changeIf the preliminary, topline or interim data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, DNTH103 or any other product candidate may be harmed, which could harm our business, financial condition, results of operations, cash flows, and prospects. 46 Table of Contents Our current or future clinical trials or those of our current or future collaborators may reveal significant adverse events or undesirable side effects not seen in our preclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of DNTH103 or any of our other product candidates or result in potential product liability claims.
Biggest changeIf the preliminary, top-line or interim data that we report differ from actual 47 Table of Contents results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, claseprubart, DNTH212 or any other product candidate may be harmed, which could harm our business, financial condition, results of operations, cash flows, and prospects.
Our future capital requirements will depend on many factors, including: • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we pursue; • our ability to establish an acceptable safety profile with IND-enabling toxicology studies to enable clinical trials; • successful patient enrollment in, and the initiation and completion of, larger and later-stage clinical trials; • per subject trial costs; • the number, extent and scope of trials required for regulatory approval; • the countries in which the trials are conducted; • the length of time required to enroll eligible subjects in clinical trials; • the number of subjects that participate in the trials; • the drop-out and discontinuation rate of subjects; • potential additional safety monitoring requested by regulatory agencies; • the duration of subject participation in the trials and follow-up; • the extent to which we encounter any serious adverse events in our clinical trials; • the timing of receipt of regulatory approvals from applicable regulatory authorities; • the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; • the extent to which we establish collaborations, strategic partnerships, or other strategic arrangements with third parties, if any, and the performance of any such third party; 39 Table of Contents • hiring and retaining research and development personnel; • our arrangements with our contract development and manufacturing organizations (“CDMOs”), and contract research organizations (“CROs”); • development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; and • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
Our future capital requirements will depend on many factors, including: • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we pursue; • our ability to establish an acceptable safety profile with IND-enabling toxicology studies to enable clinical trials; • successful patient enrollment in, and the initiation and completion of, larger and later-stage clinical trials; • per subject trial costs; • the number, extent and scope of trials required for regulatory approval; • the countries in which the trials are conducted; • the length of time required to enroll eligible subjects in clinical trials; • the number of subjects that participate in the trials; • the drop-out and discontinuation rate of subjects; • potential additional safety monitoring requested by regulatory agencies; • the duration of subject participation in the trials and follow-up; • the extent to which we encounter any serious adverse events in our clinical trials; • the timing of receipt of regulatory approvals from applicable regulatory authorities; • the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; 40 Table of Contents • the extent to which we establish collaborations, strategic partnerships, or other strategic arrangements with third parties, if any, and the performance of any such third party; • hiring and retaining research and development personnel; • our arrangements with our contract development and manufacturing organizations (“CDMOs”), and contract research organizations (“CROs”); • development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; and • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
We anticipate that our expenses will increase substantially if and as we: • advance our existing and future programs through preclinical and clinical development, including expansion into additional indications; • seek to identify additional programs and additional product candidates; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • seek regulatory and marketing approvals for product candidates; 40 Table of Contents • seek to identify, establish and maintain additional collaborations and license agreements; • ultimately establish a sales, marketing and distribution infrastructure to commercialize any drug products for which we may obtain marketing approval, either by ourselves or in collaboration with others; • generate revenue from commercial sales of products for which we receive marketing approval; • hire additional personnel including research and development, clinical and commercial personnel; • add operational, financial and management information systems and personnel, including personnel to support product development; • acquire or in-license products, intellectual property and technologies; • develop and manufacture our clinical supplies and access commercial-scale cGMP capacity and capabilities through third-parties or our own manufacturing facility; and • continue to operate as a public company.
We anticipate that our expenses will increase substantially if and as we: • advance our existing and future programs through preclinical and clinical development, including expansion into additional indications; 41 Table of Contents • seek to identify additional programs and additional product candidates; • maintain, expand, enforce, defend and protect our intellectual property portfolio; • seek regulatory and marketing approvals for product candidates; • seek to identify, establish and maintain additional collaborations and license agreements; • ultimately establish a sales, marketing and distribution infrastructure to commercialize any drug products for which we may obtain marketing approval, either by ourselves or in collaboration with others; • seek to generate revenue from commercial sales of products for which we receive marketing approval; • hire additional personnel including research and development, clinical and commercial personnel; • add operational, financial and management information systems and personnel, including personnel to support product development; • acquire or in-license products, intellectual property and technologies; • develop and manufacture our clinical supplies and access commercial-scale cGMP capacity and capabilities through third-parties or our own manufacturing facility; and • continue to operate as a public company.
Some of the factors that may cause the market price of our common stock to fluctuate include: • results of clinical trials and preclinical studies of our product candidates, or those our competitors or our existing or future collaborators; • failure to meet or exceed financial and development projections of the investment community or that we may provide to the public; • announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; 67 Table of Contents • actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and marketing terms; • disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; • additions or departures of key personnel; • significant lawsuits, including patent or stockholder litigation; • if securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading opinions regarding our business and stock; • changes in the market valuations of similar companies; • general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors; • sales of securities by us or our securityholders in the future; • if we fail to raise an adequate amount of capital to fund our operations or continued development of our product candidates; • trading volume of our common stock; • announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments; • adverse publicity relating to precision medicine product candidates, including with respect to other products in such markets; • the introduction of technological innovations or new therapies that compete with our products and services; and • period-to-period fluctuations in our financial results.
Some of the factors that may cause the market price of our common stock to fluctuate include: • results of clinical trials and preclinical studies of our product candidates, or those of our competitors or our existing or future collaborators; • failure to meet or exceed financial and development projections of the investment community or that we may provide to the public; • announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; • actions taken by regulatory agencies with respect to our product candidates, clinical studies, manufacturing process or sales and marketing terms; • disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; • additions or departures of key personnel; • significant lawsuits, including patent or stockholder litigation; • if securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading opinions regarding our business and stock; • changes in the market valuations of similar companies; • general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors; • sales of securities by us or our securityholders in the future; • if we fail to raise an adequate amount of capital to fund our operations or continued development of our product candidates; • trading volume of our common stock; • announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments; • adverse publicity relating to precision medicine product candidates, including with respect to other products in such markets; • the introduction of technological innovations or new therapies that compete with our products and services; and • period-to-period fluctuations in our financial results.
We or our collaborators also may experience numerous unforeseen events during, or as a result of, any current or future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize DNTH103 or any other product candidates, including: • IRBs, the FDA or other regulators, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • clinical trial sites deviating from trial protocol or dropping out of a trial; • clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs; • the number of subjects required for clinical trials of any of our product candidates may be larger than we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority trials, enrollment in these clinical trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; • our 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; 42 Table of Contents • 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 the participants in our trials are being exposed to unacceptable health risks; • the cost of clinical trials of any of our product candidates may be greater than we anticipate; • the quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial; • our inability to manufacture sufficient quantities of our product candidates for use in clinical trials, or delays in manufacturing or distribution; • reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; • our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other therapies in the same class as our product candidates; and • the FDA or other regulatory authorities may require us to submit additional data such as additional toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
We or our collaborators also may experience numerous unforeseen events during, or as a result of, any current or future clinical trials that we could conduct that could 43 Table of Contents delay or prevent our ability to receive marketing approval or commercialize claseprubart, DNTH212 or any other product candidates, including: • IRBs, the FDA or other regulators, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • clinical trial sites deviating from trial protocol or dropping out of a trial; • clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials or we may decide to abandon product development programs; • the number of subjects required for clinical trials of any of our product candidates may be larger than we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority trials, enrollment in these clinical trials may be slower than we anticipate or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; • our 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 the participants in our trials are being exposed to unacceptable health risks; • the cost of clinical trials of any of our product candidates may be greater than we anticipate; • the quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be inadequate to initiate or complete a given clinical trial; • our inability to manufacture sufficient quantities of our product candidates for use in clinical trials, or delays in manufacturing or distribution; • reports from clinical testing of other therapies may raise safety or efficacy concerns about our product candidates; • our failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidate as well as data emerging from other therapies in the same class as our product candidates; and • the FDA or other regulatory authorities may require us to submit additional data such as additional toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
A product candidate could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including: 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 is safe and effective for its proposed indication; the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using drugs similar to a product candidate; 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 preclinical studies or clinical trials; the data collected from clinical trials of a product candidate may not be acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; the FDA or the applicable foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of a product candidate; the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
A product candidate could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including: 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 is safe and effective for its proposed indication; the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using drugs similar to a product candidate; 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 preclinical studies or clinical trials; the data collected from clinical trials of a product candidate may not be acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere, and we may be required to conduct additional clinical trials; the FDA or the applicable foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of a product candidate; the FDA or comparable foreign regulatory authorities may fail to approve the 62 Table of Contents manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Among other things, these provisions: • establish a classified board of directors such that all members of the board are not elected at one time; • allow the authorized number of our directors to be changed only by resolution of our Board of Directors; • limit the manner in which stockholders can remove directors from the Board of Directors; 69 Table of Contents • establish advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted on at stockholder meetings; • require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; • limit who may call a special meeting of stockholders; • authorize our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors; and • require the approval of the holders of at least 66.67% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
Among other things, these provisions: • establish a classified board of directors such that all members of the board are not elected at one time; • allow the authorized number of our directors to be changed only by resolution of our Board of Directors; • limit the manner in which stockholders can remove directors from the Board of Directors; • establish advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted on at stockholder meetings; • require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; • limit who may call a special meeting of stockholders; • authorize our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors; and • require the approval of the holders of at least 66.67% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected; 37 Table of Contents • In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth; • Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage; • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable.
If we are unable to maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected; 38 Table of Contents • In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth; • Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage; • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable.
Commencing clinical trials in the United States is subject to acceptance by the FDA of an IND, BLA or similar application and finalizing the trial design based on discussions with the FDA and other regulatory authorities.
Commencing clinical trials in the United States is subject to acceptance by the FDA of an IND or similar application and finalizing the trial design based on discussions with the FDA and other regulatory authorities.
We have broad discretion in the use of our cash and cash equivalents and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment. We have broad discretion over the use of our cash and cash equivalents.
We have broad discretion in the use of our cash, cash equivalents and investments and may invest or spend the proceeds in ways with which you do not agree and in ways that may not increase the value of your investment. We have broad discretion over the use of our cash, cash equivalents and investments.
Events that may prevent successful or timely initiation or completion of clinical trials include: inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; delays or failure in obtaining regulatory authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; delays in identifying, recruiting and training suitable clinical investigators; delays in obtaining required IRB approval at each clinical trial site; difficulties in patient enrollment in our clinical trials for a variety of reasons; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s GCPs or regulations or applicable regulations or regulatory guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial; changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; transfer of manufacturing processes to larger-scale facilities operated by third-party CDMOs and delays or failure by our CDMOs or us to make any necessary changes to such manufacturing process; and third parties being unwilling or unable to satisfy their contractual obligations to us.
Events that may prevent successful or timely initiation or completion of clinical trials include: inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; delays or failure in obtaining regulatory authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; delays in identifying, recruiting and training suitable clinical investigators; delays in obtaining required IRB approval at each clinical trial site; difficulties in patient enrollment in our clinical trials for a variety of reasons; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing; failure by our CROs, other third parties or us to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s cGCPs or regulations or applicable regulations or regulatory guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial; changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; selection of clinical 46 Table of Contents endpoints that require prolonged periods of observation or analyses of resulting data; transfer of manufacturing processes to larger-scale facilities operated by third-party CDMOs and delays or failure by our CDMOs or us to make any necessary changes to such manufacturing process; and third parties being unwilling or unable to satisfy their contractual obligations to us.
If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate; • If we encounter difficulties enrolling patients in our current or future clinical trials, our clinical development activities could be delayed or otherwise adversely affected; • We have collaborations with third parties, including our existing license and development collaboration with Tenacia.
If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate; • If we encounter difficulties enrolling patients in our current or future clinical trials, our clinical development activities could be delayed or otherwise adversely affected; • We have collaborations with third parties, including our existing license and development collaborations with Tenacia and Leads.
If we or our current or future collaborators are unable to complete development of, or commercialize, our product candidates, or experience significant delays in doing so, our business will be materially harmed; • We are substantially dependent on the success of our most advanced product candidate, DNTH103, and our anticipated clinical trials of such candidate may not be successful; • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of DNTH103 or any other product candidates may be delayed and our expenses may increase and our stock price may decline; • Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value; • Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
If we or our current or future collaborators are unable to complete development of, or commercialize, our product candidates, or experience significant delays in doing so, our business will be materially harmed; • We are substantially dependent on the success of our most advanced product candidate, claseprubart, and our anticipated clinical trials of such candidate may not be successful; • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of claseprubart, DNTH212 or any other product candidates may be delayed and our expenses may increase and our stock price may decline; • Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value; • Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
Market participants with significant influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic with a target product profile such as that of DNTH103 or for its targeted indications, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any product candidates developed by us or our existing or future collaborators.
Market participants with significant influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic with a target product profile such as that of claseprubart or for its targeted indications, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any product candidates developed by us or our existing or future collaborators.
We may not be successful in such a transition. 38 Table of Contents We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate clinical trials, product development programs or future commercialization efforts.
We may not be successful in such a transition. 39 Table of Contents We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate clinical trials, product development programs or future commercialization efforts.
For example, we are initially focused on our most advanced product candidate, DNTH103. As a result, we may forgo or delay pursuit of opportunities with other potential candidates that may later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
For example, we are initially focused on our most advanced product candidate, claseprubart. As a result, we may forgo or delay pursuit of opportunities with other potential candidates that may later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
We may expend our limited resources to pursue a particular product candidate, such as DNTH103, and fail to capitalize on candidates that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and managerial resources, we intend to focus our research and development efforts on certain selected product candidates.
We may expend our limited resources to pursue a particular product candidate, such as claseprubart, and fail to capitalize on candidates that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and managerial resources, we intend to focus our research and development efforts on certain selected product candidates.
We do not expect to generate product revenue unless or until we successfully complete clinical development and obtains regulatory approval of, and then successfully commercialize, at least one product candidate. We may never succeed in these activities and, even if we do, may never generate product revenue or revenues that are significant or large enough to achieve profitability.
We do not expect to generate product revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, at least one product candidate. We may never succeed in these activities and, even if we do, may never generate product revenue or revenues that are significant or large enough to achieve profitability.
DNTH103 is purposefully designed to improve upon currently approved products and existing product candidates. However, the scientific research that forms the basis of our efforts to develop a product candidate using only the classical complement pathway and half-life extension technologies is ongoing and may not result in viable product candidates.
Claseprubart is purposefully designed to improve upon currently approved products and existing product candidates. However, the scientific research that forms the basis of our efforts to develop a product candidate using only the classical complement pathway and half-life extension technologies is ongoing and may not result in viable product candidates.
Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value. Our approach to the discovery and development of DNTH103 leverages clinically validated mechanisms of action and incorporates advanced antibody engineering properties designed to overcome limitations of existing therapies.
Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value. Our approach to the discovery and development of claseprubart leverages clinically validated mechanisms of action and incorporates advanced antibody engineering properties designed to overcome limitations of existing therapies.
We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct multiple Phase 2 clinical trials and a Phase 3 clinical trial, prepare for additional IND and other regulatory filings, potentially initiate additional clinical trials, and continue to research, develop and conduct preclinical studies of our other potential product candidates.
We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct multiple Phase 2 and Phase 3 clinical trials, prepare for additional IND and other regulatory filings, potentially initiate additional clinical trials, and continue to research, develop and conduct preclinical studies of our other potential product candidates.
If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
We are not permitted to market or promote this product candidate, or any other product candidates, before we receive marketing approval from the FDA and/or comparable foreign regulatory authorities, and we may never receive such marketing approvals. The success of DNTH103 will depend on a variety of factors.
We are not permitted to market or promote this product candidate, or any other product candidates, before we receive marketing approval from the FDA and/or comparable foreign regulatory authorities, and we may never receive such marketing approvals. The success of claseprubart will depend on a variety of factors.
We perform periodic audits of each CDMO facility that supports our supply of DNTH103 and review/approve all DNTH103 cGMP-related documentation. We also have a quality agreement with WuXi Biologics that documents our mutual agreement on compliance with cGMPs and expectations on quality-required communications to us.
We perform periodic audits of each CDMO facility that supports our supply of claseprubart and review/approve all claseprubart cGMP-related documentation. We also have a quality agreement with WuXi Biologics that documents our mutual agreement on compliance with cGMPs and expectations on quality-required communications to us.
You may not agree with our decisions, and our use of the proceeds may not yield any return on your investment. Our failure to apply these resources effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of these net proceeds.
You may not agree with our decisions, and our use of the proceeds may not yield any return on your investment. Our failure to apply these resources effectively could compromise our ability to pursue our growth strategy and we might not be able to yield a significant return, if any, on our investment of these cash resources.
Before obtaining regulatory approvals for the commercial sale of our product candidates, including our most advanced product candidate, DNTH103, we must demonstrate through lengthy, complex and expensive preclinical and clinical trials that such product candidates are both safe and effective for each targeted indication.
Before obtaining regulatory approvals for the commercial sale of our product candidates, including our most advanced product candidate, claseprubart, we must demonstrate through lengthy, complex and expensive preclinical and clinical trials that such product candidates are both safe and effective for each targeted indication.
For example, in the event that we need to transfer from WuXi Biologics, which is our sole manufacturing source for DNTH103, we anticipate that the complexity of the manufacturing process may materially impact the amount of time it would take to secure a replacement manufacturer.
For example, in the event that we need to transfer from WuXi Biologics, which is our sole manufacturing source for claseprubart, we anticipate that the complexity of the manufacturing process may materially impact the amount of time it would take to secure a replacement manufacturer.
An extended half-life may make it more difficult for patients to change treatments and there is a perception that half-life extension could exacerbate side effects, each of which may adversely affect our ability to gain market acceptance. Market acceptance of DNTH103 or any other product candidates will depend on many factors, including factors that are not within our control.
An extended half-life may make it more difficult for patients to change treatments and there is a perception that half-life extension could exacerbate side effects, each of which may adversely affect our ability to gain market acceptance. Market acceptance of claseprubart, DNTH212 or any other product candidates will depend on many factors, including factors that are not within our control.
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. 65 Table of Contents Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to supply product candidates, including DNTH103, in a timely manner or within budget.
The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to supply product candidates, including claseprubart, in a timely manner or within budget.
We cannot provide assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with product generated under cGMP regulations.
We cannot provide assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with cGCP regulations. In addition, our clinical trials must be conducted with product generated under cGMP regulations.
We, the FDA, EU member states, or other applicable regulatory authorities, or an IRB or ethics committee, may suspend any clinical trials of DNTH103 or any other product candidates at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects.
We, the FDA, EU member states, or other applicable regulatory authorities, or an IRB or ethics committee, may suspend any clinical trials of claseprubart, DNTH212 or any other product candidates at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects.
Any regulatory approvals that we may receive for DNTH103 or other product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of such product candidates, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements.
Any regulatory approvals that we may receive for claseprubart, DNTH212 or other product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of such product candidates, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements.
We and our third-party contractors and CROs are required to comply with GCP regulations, which are guidelines enforced by the FDA and comparable foreign regulatory authorities for any product candidate in clinical development.
We and our third-party contractors and CROs are required to comply with cGCP regulations, which are guidelines enforced by the FDA and comparable foreign regulatory authorities for any product candidate in clinical development.
Due to our limited financial resources and the limited experience of our management team working together in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. 52 Table of Contents We are highly dependent on our key personnel, and we anticipate hiring new key personnel.
Due to our limited financial resources and the limited experience of our management team working together in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. We are highly dependent on our key personnel, and we anticipate hiring new key personnel.
It is difficult to monitor whether our licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to the licensed technology in the event of misuse. 61 Table of Contents In addition, the U.S. federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act.
It is difficult to monitor whether our licensors limit their use of the technology to these uses, and we could incur substantial expenses to enforce our rights to the licensed technology in the event of misuse. In addition, the U.S. federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act.
If we are required to conduct additional clinical trials or other testing of DNTH103 or any other product candidates beyond those that we contemplate, if we unable to successfully complete clinical trials of DNTH103 or any other product candidates, if the results of these trials are not positive or are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected and we may incur significant additional costs.
If we are required to conduct additional clinical trials or other testing of claseprubart, DNTH212 or any other product candidates beyond those that we contemplate, if we unable to successfully complete clinical trials of claseprubart, DNTH212 or any other product candidates, if the results of these trials are not positive or are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected and we may incur significant additional costs.
The enrollment of patients in current or future trials for DNTH103 or any other product candidates will depend on many factors, including if patients choose to enroll in clinical trials, rather than using approved products, or if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates, and patients instead enroll in such clinical trials.
The enrollment of patients in current or future trials for claseprubart, DNTH212 or any other product candidates will depend on many factors, including if patients choose to enroll in clinical trials, rather than using approved products, or if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates, and patients instead enroll in such clinical trials.
If any CDMO on which we will rely fails to manufacture quantities of a product candidate at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand at a cost that allows us to achieve profitability, our business, financial condition, cash flows, and prospects could be materially and adversely affected.
If any CDMO on which we will rely fails to manufacture quantities of claseprubart at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand at a cost that allows us to achieve profitability, our business, financial condition, cash flows, and prospects could be materially and adversely affected.
DNTH103 will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales, if any.
Claseprubart will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales, if any.
In addition, a European Unified Patent Court (the “UPC”) came into force June 1, 2023. The UPC is a common patent court to hear patent infringement and revocation proceedings effective for member states of the European Union.
In addition, a European Unified Patent Court (the “UPC”) came into force June 1, 2023. The UPC is a common patent court to hear patent infringement and revocation proceedings effective for member states of the EU.
We conducted our Phase 1 clinical trial for DNTH103 in New Zealand, we are currently conducting our Phase 2 clinical trials and our Phase 3 clinical trial for DNTH103 in the United States and outside the United States, and we may in the future choose to conduct more of our clinical trials outside the United States.
We conducted our Phase 1 clinical trial for claseprubart in New Zealand, we are currently conducting our Phase 2 clinical trials and our Phase 3 clinical trial for claseprubart in the United States and outside the United States, and we may in the future choose to conduct more of our clinical trials outside the United States.
These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with current cGMPs and GCPs for any clinical trials that we conduct following approval.
These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with current cGMPs and cGCPs for any clinical trials that we conduct following approval.
This technology and DNTH103 or any product candidates resulting therefrom may not demonstrate the same chemical and pharmacological properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways. In addition, we may in the future seek to discover and develop product candidates that are based on novel targets and technologies that are unproven.
This technology and claseprubart, DNTH212 or any product candidates resulting therefrom may not demonstrate the same chemical and pharmacological properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways. In addition, we may in the future seek to discover and develop product candidates that are based on novel targets and technologies that are unproven.
See the sections titled “ Business—Government Regulation—Coverage and Reimbursement ” and “ —Regulation in the European Union ” located elsewhere in this Annual Report on Form 10-K for a more detailed description of the government regulations and third-party payor practices that may affect our ability to commercialize our product candidates.
See the sections titled “ Business—Government 65 Table of Contents Regulation—Coverage and Reimbursement ” and “ —Regulation in the European Union ” located elsewhere in this Annual Report on Form 10-K for a more detailed description of the government regulations and third-party payor practices that may affect our ability to commercialize our product candidates.
The long-term safety and efficacy of these technologies and exposure profile of DNTH103 compared to currently approved products is unknown. We may ultimately discover that our technologies for our specific targets and indications and DNTH103 or any product candidates resulting therefrom do not possess certain properties required for therapeutic effectiveness.
The long-term safety and efficacy of these technologies and exposure profile of claseprubart compared to currently approved products is unknown. We may ultimately discover that our technologies for our specific targets and indications and claseprubart, DNTH212 or any product candidates resulting therefrom do not possess certain properties required for therapeutic effectiveness.
Any of these occurrences could harm our business, financial condition, results of operations, cash flows, and prospects significantly. In addition, even if we successfully advance DNTH103 or any other product candidates through clinical trials, such trials will only include a limited number of patients and limited duration of exposure to such product candidates.
Any of these occurrences could harm our business, financial condition, results of operations, cash flows, and prospects significantly. In addition, even if we successfully advance claseprubart, DNTH212 or any other product candidates through clinical trials, such trials will only include a limited number of patients and limited duration of exposure to such product candidates.
If there should be any disruption in such supply arrangement, including any adverse events affecting our sole supplier, Wuxi Biologics, it could have a negative effect on the clinical development of our product candidates and other operations while we work to identify and qualify an alternate supply source.
If there should be any disruption in such supply arrangement, including any adverse events affecting our sole supplier, Wuxi Biologics, it could have a negative effect on the clinical development of claseprubart and other operations while we work to identify and qualify an alternate supply source.
We could also encounter delays if a clinical trial is placed on clinical hold, suspended or terminated by us, the FDA, the competent authorities of the European Union (“EU”), member states or other regulatory authorities or the IRBs or ethics committees of the institutions in which such trials are being conducted, if a clinical trial is recommended for suspension or termination by the data safety monitoring board or equivalent body for such trial, or on account of changes to federal, state, or local laws.
We could also encounter delays if a clinical trial is placed on clinical hold, suspended or terminated by us, the FDA, the competent authorities of the EU, member states or other regulatory authorities or the IRBs or ethics committees of the institutions in which such trials are being conducted, if a clinical trial is recommended for suspension or termination by the data safety monitoring board or equivalent body for such trial, or on account of changes to federal, state, or local laws.
If we fail to maintain the patents and patent applications covering our product candidates, our competitive position would be adversely affected. 60 Table of Contents We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
If we fail to maintain the patents and patent applications covering our product candidates, our competitive position would be adversely affected. We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of DNTH103 or other product candidates. 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.
Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of claseprubart, DNTH212 or other product candidates. 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.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. We may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. 67 Table of Contents We may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials.
If our discovery activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable for treating human disease, we may not be able to develop viable additional product candidates. We and our existing or future collaborators may never receive approval to market and commercialize DNTH103 or any other product candidates.
If our discovery activities fail to identify novel targets or technologies for drug discovery, or such targets prove to be unsuitable for treating human disease, we may not be able to develop viable additional product candidates. We and our existing or future collaborators may never receive approval to market and commercialize claseprubart, DNTH212 or any other product candidates.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. 59 Table of Contents Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
The occurrence of any event or penalty described above may inhibit our ability to commercialize DNTH103 or other product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity. We may face difficulties from healthcare legislative reform measures.
The occurrence of any event or penalty described above may inhibit our ability to commercialize claseprubart, DNTH212 or other product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity. We may face difficulties from healthcare legislative reform measures.
Although we believe we currently maintain adequate product liability insurance for DNTH103 and other product candidates, it is possible that our liabilities could exceed our insurance coverage or that in the future we may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise.
Although we believe we currently maintain adequate product liability insurance for claseprubart, DNTH212 and other product candidates, it is possible that our liabilities could exceed our insurance coverage or that in the future we may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise.
In addition, while we initiated two Phase 2 clinical trials and one Phase 3 clinical trial with DNTH103 in patients with gMG, MMN and CIDP, respectively, we have not completed a late-stage clinical trial for any product candidate, have no products approved for commercial sale and have not yet demonstrated our ability to successfully complete late-stage clinical trials (including Phase 3 or other pivotal clinical trials), obtain regulatory or marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization.
In addition, while we are conducting two Phase 2 clinical trials and one Phase 3 clinical trial with claseprubart in patients with gMG, MMN and CIDP, respectively, we have not completed a late-stage clinical trial (including Phase 3 or other pivotal clinical trials) for any product candidate, have no products approved for commercial sale and have not yet demonstrated our ability to successfully complete late-stage clinical trials, obtain regulatory or marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization.
If the products resulting from DNTH103 or any other product candidates prove to be ineffective, unsafe or commercially unviable, our product candidates and pipeline may have little, if any, value, which may have a material and adverse effect on our business, financial condition, results of operations, cash flows, and prospects.
If the products resulting from claseprubart, DNTH212 or any other product candidates prove to be ineffective, unsafe or commercially unviable, our product candidates and pipeline may have little, if any, value, which may have a material and adverse effect on our business, financial condition, results of operations, cash flows, and prospects.
We have publicly disclosed and may in the future publicly disclose preliminary or topline data from our preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data.
We have publicly disclosed and may in the future publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data.
For example, upon submission or after approval of an IND or CTA for a clinical trial of DNTH103, the FDA, EMA or comparable foreign regulatory authorities may recommend or require changes to our protocol or study designs that could adversely affect our study timelines and/or ability to enroll patients.
For example, upon submission or after approval of an IND or CTA for a clinical trial of claseprubart or DNTH212, the FDA, EMA or comparable foreign regulatory authorities may recommend or require changes to our protocol or study designs that could adversely affect our study timelines and/or ability to enroll patients.
To obtain separate regulatory approval in many other countries, we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of DNTH103 or other product candidates, and we cannot predict success in these jurisdictions.
To obtain separate regulatory approval in many other countries, we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of claseprubart, DNTH212 or other product candidates, and we cannot predict success in these jurisdictions.
Lastly, if our trademarks and trade names are not registered or adequately protected, then we may not be able to build name recognition in markets of interest and our business may be adversely affected. We may not be successful in obtaining or maintaining necessary rights to product candidates through acquisitions and in-licenses.
Lastly, if our trademarks and trade names are not registered or adequately protected, then we may not be able to build name recognition in markets of interest and our business may be adversely affected. 57 Table of Contents We may not be successful in obtaining or maintaining necessary rights to product candidates through acquisitions and in-licenses.
If the FDA or a comparable foreign regulatory authority does not approve these facilities and the associated Quality Management System for the manufacture of a product candidate or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs and materially and adversely affect our ability to develop, obtain regulatory approval for or market such product candidate, if approved.
If the FDA or a comparable foreign regulatory authority does not approve these facilities and the associated Quality Management System for the manufacture of claseprubart or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs and materially and adversely affect our ability to develop, obtain regulatory approval for or market claseprubart, if approved.
Similarly, our failure, or the failure of our CDMO, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of a product candidate or drug and harm our business and results of operations.
Similarly, our failure, or the failure of our CDMO, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of claseprubart and harm our business and results of operations.
As a result, the preliminary or topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.
As a result, the preliminary or top-line results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.
If any of the foregoing events occur or if DNTH103 or any other product candidates prove to be unsafe, our entire pipeline could be affected, which would have a material adverse effect on our business, financial condition, results of operations, cash flows, and prospects.
If any of the foregoing events occur or if claseprubart, DNTH212 or any other product candidates prove to be unsafe, our entire pipeline could be affected, which would have a material adverse effect on our business, financial condition, results of operations, cash flows, and prospects.
Even if we receive regulatory approval of DNTH103 or other product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
Even if we receive regulatory approval of claseprubart, DNTH212 or other product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, DNTH103 or any other product candidates.
We may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, claseprubart, DNTH212 or any other product candidates.
If we fail to comply with the regulatory requirements in international markets or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of DNTH103 or other product candidates will be harmed, and our business will be adversely affected.
If we fail to comply with the regulatory requirements in international markets or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of claseprubart, DNTH212 or other product candidates will be harmed, and our business will be adversely affected.
Even if we are able to commercialize DNTH103 or other product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such products at competitive prices which would seriously harm our business.
Even if we are able to commercialize claseprubart, DNTH212 or other product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, we may not be able to offer such products at competitive prices which would seriously harm our business.
The success of DNTH103 may depend on having a comparable safety and efficacy profile and a more favorable dosing schedule (i.e., less frequent dosing) and more patient-friendly administration (i.e., S.C. self-administration using a pen or other prefilled device) to products currently approved or in development for the indications we are pursuing or may in the future pursue .
The success of claseprubart may depend on having a potentially differentiated safety profile, comparable efficacy profile and a more favorable dosing schedule (i.e., less frequent dosing) and more patient-friendly administration (i.e., S.C. self-administration using a pen or other prefilled device) to products currently approved or in development for the indications we are pursuing or may in the future pursue .
The lengthy approval process as well as the unpredictability of future clinical trial results may result in us failing to obtain regulatory approval to market DNTH103 or other product candidates, which would significantly harm our business, results of operations and prospects.
The lengthy approval process as well as the unpredictability of future clinical trial results may result in us failing to obtain regulatory approval to market claseprubart, DNTH212 or other product candidates, which would significantly harm our business, results of operations and prospects.
We will assess the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where we have operations to determine the potential effect on our business and any assumptions we will make about our future taxable income.
We will assess the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where we have operations to determine the potential effect on our business 71 Table of Contents and any assumptions we will make about our future taxable income.
Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for, and successfully commercializing, DNTH103 or other product candidates either alone or with third parties, and we cannot guarantee that we will ever obtain regulatory approval for any product candidates.
Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for, and successfully commercializing, claseprubart, DNTH212 or other product candidates either alone or with third parties, and we cannot guarantee that we will ever obtain regulatory approval for any product candidates.
Potential side effects associated with DNTH103, or any other product candidates, may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from DNTH103, or any other product candidates, may not be normally encountered in the general patient population and by medical personnel.
Potential side effects associated with claseprubart, DNTH212 or any other product candidates, may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from claseprubart, DNTH212 or any other product candidates, may not be normally encountered in the general patient population and by medical personnel.
As part of our strategy, we plan to evaluate additional opportunities to enhance our capabilities and expand our development pipeline or provide development or commercialization capabilities that complement our own. We may not realize the benefits of such collaborations, alliances or licensing arrangements.
As part of our strategy, we plan to evaluate additional opportunities to enhance our capabilities and expand our development pipeline or provide development or commercialization capabilities that complement our own. We may not realize the benefits of such 52 Table of Contents collaborations, alliances or licensing arrangements.
If we do not meet these milestones as publicly announced, or at all, the commercialization of DNTH103 or any other product candidates may be delayed or never achieved and, as a result, our stock price may decline.
If we do not meet these milestones as publicly announced, or at all, the commercialization of claseprubart, DNTH212 or any other product candidates may be delayed or never achieved and, as a result, our stock price may decline.
If DNTH103 or any other product candidate is approved but does not achieve an adequate level of acceptance by such parties, we may not generate or derive sufficient revenue from that product and may not become or remain profitable.
If claseprubart, DNTH212 or any other product candidate is approved but does not achieve an adequate level of acceptance by such parties, we may not generate or derive sufficient revenue from that product and may not become or remain profitable.
Our internal information technology systems, or those of any of our CROs, CDMOs, other contractors, third party service providers or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
Our internal information technology systems, or those of any of our CROs, CDMOs, other contractors, third party service providers or consultants or potential future collaborators, may fail or experience cybersecurity incidents or data privacy breaches or other unauthorized or improper access to, use of, or destruction of proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
We intend to seek approval to market DNTH103 and other product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for such product candidates, we will be subject to rules and regulations in those jurisdictions.
We intend to seek approval to market claseprubart, DNTH212 and other product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for such product candidates, we will be subject to rules and regulations in those jurisdictions.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

9 edited+1 added−0 removed7 unchanged
Biggest changeS enior management is directly involved with our efforts to prevent, detect, and mitigate cybersecurity incidents by overseeing preparation of cybersecurity policies and procedures, testing incident response plans and engaging vendors to conduct penetration tests. Senior management participates in cybersecurity incident response efforts by being part of the incident response team and helping direct our response to cybersecurity incidents.
Biggest changeOur cybersecurity risk assessment processes are integrated into our broader risk management and disclosure processes. 72 Table of Contents Senior management is directly involved with our efforts to prevent, detect, and mitigate cybersecurity incidents by overseeing preparation of cybersecurity policies and procedures, testing incident response plans and engaging vendors to conduct penetration testing and other security assessments.
To augment internal knowledge, we have engaged a virtual Chief Information Security Officer (“vCISO”) from a third-party firm that has provided IT and security services for over 18 years and utilizes industry expertise to recommend and implement best practice solutions for operational needs.
To augment internal knowledge, we have engaged a virtual Chief Information Security Officer (“vCISO”) from a third-party firm that has provided IT and security services for over 19 years and utilizes industry expertise to recommend and implement best practice solutions for operational needs.
To that end, w e rely on a multidisciplinary team (including from our IT function, senior management, and third-party service providers, as described further below) to assess how identified cybersecurity threats could impact our business. These assessments may leverage, among other processes, industry tools and metrics designed to assist in the assessment of risks from such cybersecurity threats.
To that end, we rely on a multidisciplinary team (including from our IT function, senior management, and third-party service providers, as described further below) to assess how identified cybersecurity threats could impact our business. These assessments may leverage, among other processes, industry tools and metrics designed to assist in the assessment of risks from such cybersecurity threats.
Risk Factors ” in this Annual Report on Form 10-K for additional information on cybersecurity risks we face. Information from the risk management process is managed by the Information Security Team and is reported to the Board of Directors on a regular basis. We provide cybersecurity updates to our Audit Committee on a quarterly basis.
See “ Item 1A. Risk Factors ” in this Annual Report on Form 10-K for additional information on cybersecurity risks we face. Information from the risk management process is managed by the Information Security Team and is reported to the Board of Directors on a regular basis. We provide cybersecurity updates to our Audit Committee on a quarterly basis.
Item 1C. Cyb ersecurity. We take cyber risk seriously as a part of modern enterprise risk management, protecting our stakeholders and assets, and building resilient processes. The modern threat landscape requires us to consider cyber risks, and make determinations regarding how to treat the risks. We evaluate cybersecurity risks alongside other business risks.
Item 1C. Cyb ersecurity. We take cyber risk seriously as a part of modern enterprise risk management, protecting our stakeholders and assets, and building resilient processes. The modern threat landscape requires us to consider cyber risks, and make determinations regarding how to treat the risks. We evaluate cybersecurity risks alongside other operational, financial and compliance risks.
The service provides a named vCISO as part of an advisory team to assess and help manage our cybersecurity program. Cybersecurity risks are identified and processed in a Risk Register by an information security team that includes the vCISO and internal management.
The service provides a named vCISO as part of an advisory team to assess and help manage our cybersecurity program ; including acting as a dedicated point of contact for incident response, triage, continued improvement, and program maturity. Cybersecurity risks are identified and processed in a Risk Register by an information security team that includes the vCISO and internal management.
In the last fiscal year, we have not identified risks from known cybersecurity threats , including as a result of any prior cybersecurity incidents, that have materially affected us, but we face certain ongoing cybersecurity risks threats that, if realized, are reasonably likely to materially affect us. See “ Item 1A.
Since the beginning of the last fiscal year , we have not identified risks from known cybersecurity threats , including as a result of any prior cybersecurity incidents, that have materially affected us, including our business strategy, results of operations or financial condition, but we face certain ongoing cybersecurity risks threats that, if realized, are reasonably likely to materially affect us.
In the case of an incident, relevant members of the Information Security Team are involved to assess and oversee incident response operations as needed, including adequate reporting of material incidents if/when appropriate. Notwithstanding the approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us.
In the case of an incident, relevant members of the Information Security Team are involved to assess and oversee incident response operations as needed, including adequate reporting of material incidents if/when appropriate. Cybersecurity incidents are evaluated under our disclosure controls and procedures.
While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. 73 Table of Contents
Notwithstanding the approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us. While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured.
Added
Senior management participates in cybersecurity incident response efforts by being part of the incident response team and helping direct our response to cybersecurity incidents. Our incident response procedures include defined escalation protocols and cross-functional evaluation involving information security, legal and senior management to assess the severity and potential materiality of cybersecurity incidents and to determine appropriate response and disclosure actions.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOur space in Waltham is approximately 2,750 square feet under a lease that expires in January 2026, our space in New York is approximately 3,367 square feet under a lease that expires in February 2031 and our space in Watertown varies monthly based on our needs but does not exceed 1,000 square feet under a lease that expires in August 2025.
Biggest changeOur space in Waltham is approximately 2,750 square feet under a lease that expires in January 2027 and our space in New York is approximately 3,367 square feet under a lease that expires in February 2031. Our New York office is our corporate headquarters.
Item 2. Proper ties. We are currently a remote-based company, and a majority of our employees work remotely. We currently lease space for administrative offices in Waltham, Massachusetts and New York, New York and wet laboratory space in Watertown, Massachusetts.
Item 2. Proper ties. We are currently a remote-based company, and a majority of our employees work remotely. We currently lease space for administrative offices in Waltham, Massachusetts and New York, New York.
Our New York office is our corporate headquarters. As the company expands, we believe suitable additional, or substitute space will be available as and when needed.
As the company expands, we believe suitable additional, or substitute space will be available as and when needed. 73 Table of Contents

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 74 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 75 Item 6. [Reserved] 75 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 87 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 74 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 75 Item 6. [Reserved] 75 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 88 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Equity Securities There were no unregistered sales of our common stock during the quarter ended December 31, 2024. Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the quarter ended December 31, 2024.
Biggest changeRecent Sales of Unregistered Equity Securities There were no unregistered sales of our common stock during the quarter ended December 31, 2025. Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the quarter ended December 31, 2025.
Item 5. Market for Registrant’s Commo n Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “DNTH”. Common Stockholders As of March 7, 2025, there were approximately 5 stockholders of record of our common stock based on information provided by our transfer agent.
Item 5. Market for Registrant’s Commo n Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “DNTH”. Common Stockholders As of March 4, 2026, there were approximately 5 stockholders of record of our common stock based on information provided by our transfer agent.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThe non-cash operating expenses consisted mainly of stock-based compensation expense of $2.9 million and amortization of right-of-use lease assets of $0.3 million, partially offset by accretion of discount on investments of $1.4 million.
Biggest changeThe non-cash operating expenses consisted primarily of stock-based compensation expense of $12.9 million and amortization of right-of-use operating lease assets of $0.3 million, partially offset by accretion of discount on investment securities of $6.0 million and a gain on an investment in a former related party of $0.1 million. 85 Table of Contents Cash Flows from Investing Activities For the year ended December 31, 2025, net cash used in investing activities consisted primarily of $435.0 million of purchases of investment securities and capital expenditures of $0.2 million, partially offset by $312.4 million of proceeds from sales and maturities of investment securities.
After the assignment, we entered into a novation agreement (the “Novation Agreement”) with Zenas HK and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”), and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas Agreements, and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.
After the assignment, we entered into a novation agreement (the “Novation Agreement”) with Zenas and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas Agreements and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.
Most of these developments and factors are outside of our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to Dianthus’ business, results of operations, liquidity and capital resources. For additional information, see the section titled “ Item 1A.
Most of these developments and factors are outside of our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to our business, results of operations, liquidity and capital resources. For additional information, see the section titled “ Item 1A.
Risk Factors ” found elsewhere in this Annual Report on Form 10-K. Components of Results of Operations Revenue Since inception, we have not generated any revenue from product sales, and we do not expect to generate any revenue from the sales of products in the foreseeable future.
Risk Factors ” found elsewhere in this Annual Report on Form 10-K. Components of Results of Operations Revenues Since inception, we have not generated any revenue from product sales, and we do not expect to generate any revenue from the sales of products in the foreseeable future.
We utilize CROs for research and development activities and CDMOs for manufacturing activities and we do not have significant laboratory or manufacturing facilities. Therefore, we have no material facilities expenses attributed to research and development. Product candidates in later stages of development generally have higher development costs than those in earlier stages.
We utilize CROs for research and development activities and CDMOs for manufacturing activities and we do not have laboratory or manufacturing facilities. Therefore, we have no material facilities expenses attributed to research and development. Product candidates in later stages of development generally have higher development costs than those in earlier stages.
In accruing expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly.
In accruing expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expense accordingly.
(formerly Zenas BioPharma Limited) (“Zenas”), a related party, which provided Zenas with a license in Greater China for the development and commercialization of certain sequences and products under an identified antibody sequence (the “Zenas License Agreement”).
(formerly Zenas BioPharma Limited) (“Zenas”), a former related party, which provided Zenas with a license in Greater China for the development and commercialization of certain sequences and products under an identified antibody sequence (the “Zenas License Agreement”).
The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to us: (i) a $2.5 million upfront payment, which was paid by Tenacia to us in October 2024 upon execution of the Tenacia License Agreement; (ii) reimbursement of a portion of certain clinical costs; (iii) development milestones totaling up to $15.0 million; and (v) royalties on net sales ranging from the mid-single digits to the low teen percentages.
The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to us: (i) a $2.5 million upfront payment, which was paid by Tenacia to us in October 2024 upon execution of the Tenacia License Agreement; (ii) reimbursement of a portion of certain clinical costs; (iii) development milestones totaling up to $15.0 million; and (iv) royalties on net sales ranging from the mid-single digits to the low teen percentages.
GAAP”). The preparation of the financial statements and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.
The preparation of the financial statements and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.
As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. See the section titled “ Item 1A. Risk Factors ” found elsewhere in this Annual Report on Form 10-K for additional risks associated with our substantial capital requirements.
As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. See the section titled “ Risk Factors ” found elsewhere in this Annual Report on Form 10-K for additional risks associated with our substantial capital requirements.
Our future funding requirements will depend on many factors, including: • the scope, timing, progress, results, and costs of researching and developing DNTH103, and conducting larger and later-stage clinical trials; • the scope, timing, progress, results, and costs of researching and developing other future product candidates that we may pursue; • the costs, timing, and outcome of regulatory review of our product candidates; • the costs of future activities, including product sales, medical affairs, marketing, manufacturing, and distribution, for any of our product candidates for which we receive marketing approval; • the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch; • the revenue, if any, received from commercial sale of our products, should any of product candidates receive marketing approval; 83 Table of Contents • the cost and timing of attracting, hiring, and retaining skilled personnel to support our operations and continued growth; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • our ability to establish, maintain, and derive value from collaborations, partnerships or other marketing, distribution, licensing, or other strategic arrangements with third parties on favorable terms, if at all; • the extent to which we acquire or in-license other product candidates and technologies, if any; and • the costs associated with operating as a public company.
Our future funding requirements will depend on many factors, including: • the scope, timing, progress, results, and costs of researching and developing claseprubart, and conducting larger and later-stage clinical trials; • the scope, timing, progress, results, and costs of researching and developing DNTH212 or any other future product candidates that we may pursue; • the costs, timing, and outcome of regulatory review of our product candidates; 84 Table of Contents • the costs of future activities, including product sales, medical affairs, marketing, manufacturing, and distribution, for any of our product candidates for which we receive marketing approval; • the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch; • the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval; • the cost and timing of attracting, hiring, and retaining skilled personnel to support our operations and continued growth; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • our ability to establish, maintain, and derive value from collaborations, partnerships or other marketing, distribution, licensing, or other strategic arrangements with third parties on favorable terms, if at all; • the extent to which we acquire or in-license other product candidates and technologies, if any; and • the costs associated with operating as a public company.
As such, depending on the timing of payment relative to the receipt of goods or services, we may record either prepaid expenses or accrued services. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on our behalf.
As such, depending on the timing of payment relative to the receipt of goods or services, we may record either prepaid expenses or accrued services. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research and development activities on our behalf.
Our Pipeline-in-a-Product Potential for DNTH103, a Next-Generation Complement Therapeutic Our most advanced product candidate, DNTH103, is a clinical-stage, highly potent, highly selective and fully human monoclonal immunoglobulin G4 with picomolar binding affinity that is designed to selectively bind only to the active form of C1s.
Our Pipeline-in-a-Product Potential for Claseprubart, a Next-Generation Complement Therapeutic Our most advanced product candidate, claseprubart, is a clinical-stage, highly potent, highly selective and fully human monoclonal immunoglobulin G4 with picomolar binding affinity that is designed to selectively bind only to the active form of C1s.
DNTH103 is engineered with YTE half-life extension technology, a specific three amino acid change in the Fc domain, and has a pharmacokinetic (“PK”) profile designed to support less frequent, lower dose, self-administration as a convenient S.C. injection.
Claseprubart is engineered with YTE half-life extension technology, a specific three amino acid change in the Fc domain, and has a pharmacokinetic (“PK”) profile designed to support less frequent, lower dose, self-administration as a convenient S.C. injection.
To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. Revenue Recognition - Licensing Agreements We analyze our licensing agreements pursuant to ASC 606 Revenue from Contracts with Customers (“ASC 606”).
To date, there have not been any material adjustments to our prior estimates of accrued or prepaid research and development expenses. Revenue Recognition - Licensing Agreements We analyze our licensing agreements pursuant to ASC 606, Revenue from Contracts with Customers (“ASC 606”).
Other Income/(Expense) Other income/(expense) consists primarily of interest income generated from earnings on invested cash equivalents and investment securities.
Other Income/(Expense) Other income/(expense) consists primarily of interest and investment income generated from earnings on invested cash and investment securities.
External expenses include: • payments to third parties in connection with research and development, including agreements with third parties such as contract research organizations (“CROs”), clinical trial sites and consultants; • the cost of manufacturing products for use in our clinical trials and preclinical studies, including payments to contract development and manufacturing organizations (“CDMOs”) and consultants; and • payments to third parties in connection with the preclinical development of other potential product candidates, including for outsourced professional scientific development services, consulting research and collaborative research.
External expenses include: • payments to third parties in connection with research and development, including agreements with third parties, such as contract research organizations (“CROs”), clinical trial sites and consultants; • the cost of manufacturing products for use in our clinical trials and preclinical studies, including payments to contract development and manufacturing organizations (“CDMOs”) and consultants; and 79 Table of Contents • payments to third parties in connection with the preclinical development of other potential product candidates, including for outsourced professional scientific development services, consulting research and collaborative research.
As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance DNTH103 into larger and later-stage clinical trials, work to discover and develop additional product candidates, seek to expand, maintain, protect and enforce our intellectual property portfolio, and hire additional research and development personnel.
As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance claseprubart into larger and later-stage clinical trials, develop DNTH212, work to discover and develop additional product candidates, seek to expand, maintain, protect and enforce our intellectual property portfolio and hire additional research and development personnel.
We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for our lead product candidate or any future product candidates to support potential future commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company.
We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for our lead product candidate, claseprubart, DNTH212, or any other future product candidates to support potential future commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company.
The duration, costs and timing of development of DNTH103 or any future product candidates are subject to numerous uncertainties and will depend on a variety of factors, including: • the timing and progress of our preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we pursue; • our ability to establish a favorable safety profile with IND-enabling toxicology studies to enable clinical trials; • successful patient enrollment in, and the initiation and completion of, larger and later-stage clinical trials; • per subject trial costs; • the number and extent of our clinical trials required for regulatory approval; • the countries in which our clinical trials are conducted; • the length of time required to enroll eligible subjects in our clinical trials; • the number of subjects that participate in our clinical trials; • the drop-out and discontinuation rate of subjects in our clinical trials; • potential additional safety monitoring requested by regulatory agencies; • the duration of subject participation in our clinical trials and follow-up; • the extent to which we encounter any serious adverse events in our clinical trials; • the timing of receipt of regulatory approvals from applicable regulatory authorities; • the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; • the extent to which we establish collaborations, strategic partnerships, or other strategic arrangements with third parties, if any, and the performance of any such third party; • hiring and retaining research and development personnel; • our arrangements with our CDMOs and CROs; 79 Table of Contents • development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; and • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
The duration, costs and timing of development of claseprubart, DNTH212, or any other future product candidates are subject to numerous uncertainties and will depend on a variety of factors, including: • the timing and progress of our preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we pursue; • our ability to establish a favorable safety profile with Investigational New Drug application (“IND”)-enabling toxicology studies to enable clinical trials; • successful patient enrollment in, and the initiation and completion of, larger and later-stage clinical trials; • per subject trial costs; • the number and extent of our clinical trials required for regulatory approval; • the countries in which our clinical trials are conducted; • the length of time required to enroll eligible subjects in our clinical trials; • the number of subjects that participate in our clinical trials; • the drop-out and discontinuation rate of subjects in our clinical trials; • potential additional safety monitoring requested by regulatory agencies; • the duration of subject participation in our clinical trials and follow-up; • the extent to which we encounter any serious adverse events in our clinical trials; 80 Table of Contents • the timing of receipt of regulatory approvals from applicable regulatory authorities; • the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; • the extent to which we establish collaborations, strategic partnerships, or other strategic arrangements with third parties, if any, and the performance of any such third party; • hiring and retaining research and development personnel; • our arrangements with our CDMOs and CROs; • development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; and • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
The increase in net operating assets and liabilities was primarily attributable to increases in other assets of $8.2 million, prepaid expenses and other current assets of $1.6 million, and a related party receivable from Zenas of $0.5 million, partially offset by increases in accounts payable, accrued expenses and operating lease liabilities of $8.2 million and deferred revenue of $1.5 million and a decrease in unbilled receivable from Zenas of $0.2 million.
The increase in net operating assets and liabilities was primarily attributable to increases in other assets of $8.2 million, prepaid expenses and other current assets of $1.6 million, and receivables from a former related party of $0.5 million, partially offset by increases in accounts payable, accrued expenses and operating lease liabilities of $8.2 million and deferred revenue of $1.5 million and a decrease in unbilled receivable from a former related party of $0.2 million.
Tenacia is also responsible for paying local development costs in Greater China and a portion of central development costs based on the number of patients enrolled from China in our global Phase 3 studies. No milestones were achieved under the Zenas Agreements prior to novation and no milestones have been achieved to date under the Tenacia Agreements.
Tenacia is also responsible for paying local development costs in Greater China and a portion of central development costs based on the number of patients enrolled from China in our global Phase 3 studies. No milestones were achieved under the Zenas Agreements prior to novation.
License and Collaboration Agreements In August 2019, we entered into a license agreement with Alloy Therapeutics, LLC (“Alloy”) for (i) a worldwide, non-exclusive license to use the Alloy technology solely to generate Alloy antibodies and platform assisted antibodies for internal, non-clinical research purposes, and (ii) with respect to Alloy antibodies and platform assisted antibodies that are selected by us for inclusion into a partnered antibody program, a worldwide, assignable license to make, have made, use, offer for sale, sell, import, develop, manufacture, and commercialize products comprising partnered antibody programs selected from Alloy antibodies and platform assisted antibodies in any field of use.
In August 2019, we entered into a license agreement with Alloy Therapeutics, LLC (“Alloy”) for (i) a worldwide, non-exclusive license to use the Alloy technology solely to generate Alloy antibodies and platform assisted antibodies for internal, non-clinical 86 Table of Contents research purposes, and (ii) with respect to Alloy antibodies and platform assisted antibodies that are selected by us for inclusion into a partnered antibody program, a worldwide, assignable license to make, have made, use, offer for sale, sell, import, develop, manufacture, and commercialize products comprising partnered antibody programs selected from Alloy antibodies and platform assisted antibodies in any field of use.
We maintain a full valuation allowance on our federal and state deferred tax assets as we have concluded that it is more likely than not that the deferred assets will not be utilized. 80 Table of Contents Results of Operations A discussion regarding our financial condition and results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023 is presented below.
We maintain a full valuation allowance on our federal and state deferred tax assets as we have concluded that it is more likely than not that the deferred assets will not be utilized. 81 Table of Contents Results of Operations A discussion regarding our financial condition and results of operations for the year ended December 31, 2025 compared to the year ended December 31, 2024 is presented below.
We are subject to continuing risks and uncertainties in connection with legislative, regulatory, political, geopolitical and macroeconomic developments beyond our control, including inflationary pressures, general economic slowdown or a recession, high interest rates, changes in monetary policy or foreign currency exchange rates, changes in U.S. trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in financial institutions, the prospect of a shutdown of the U.S. federal government, the ongoing conflict in Ukraine, conflict in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, and supply chain disruptions.
We are subject to continuing risks and uncertainties in connection with legislative, regulatory, political, geopolitical and macroeconomic developments beyond our control, including inflationary pressures, a general economic slowdown or a recession, high interest rates, changes in monetary policy or foreign currency exchange rates, changes in trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in financial institutions, the ongoing conflict in Ukraine, conflicts in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, and supply chain disruptions.
Operating Expenses Research and Development Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of DNTH103 and other potential product candidates.
Operating Expenses Research and Development Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of claseprubart, DNTH212 and other potential product candidates.
This evaluation is subjective and requires us to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the contract.
This evaluation is subjective and requires us to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the 87 Table of Contents contract.
In addition, we anticipate that we will incur additional expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.
In addition, we will continue to incur expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.
Only participants who respond to DNTH103 in Part A, as measured as greater than or equal to one point decrease (improvement) in adjusted Inflammatory Neuropathy Cause and Treatment (“INCAT”) disability score compared to Part A baseline, will be randomized into Part B, a double-blind, placebo-controlled treatment period of up to 52 weeks, where they will be assessed for prevention of relapse, safety and tolerability, followed by an open-label extension period.
Only participants who respond to claseprubart in Part A, as measured as greater than or equal to one point decrease (improvement) in adjusted Inflammatory Neuropathy Cause and Treatment (“INCAT”) disability score compared to Part A baseline, are randomized into Part B, a double-blind, placebo-controlled treatment period of up to 52 weeks, where they will be assessed for prevention of relapse, safety and tolerability, followed by an OLE period.
The successful development of DNTH103 or any future product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, DNTH103 or any future product candidates.
The successful development of claseprubart, DNTH212, or any other future product candidates, if any, is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, claseprubart, DNTH212, or any other future product candidates, if any.
We have recognized revenues attributable to upfront payments and cost reimbursements under our license agreements. If our development efforts for DNTH103 or any future product candidates are successful and result in regulatory approval, we may generate revenue from future product sales.
We have recognized revenues attributable to upfront payments, milestone payments and cost reimbursements under our license agreements. If our development efforts for claseprubart, DNTH212, or any other future product candidates, if any, are successful and result in regulatory approval, we may generate revenue from future product sales.
Internal expenses include: • personnel-related costs, including salaries, bonuses, related benefits and stock-based compensation expenses for employees engaged in research and development functions; and • facilities-related expenses, depreciation, supplies, travel expenses and other allocated expenses. 78 Table of Contents We recognize research and development expenses in the periods in which they are incurred.
Internal expenses include: • personnel-related costs, including salaries, bonuses, related benefits and stock-based compensation expenses for employees engaged in research and development functions; and • depreciation, supplies, travel expenses and other allocated expenses. We recognize research and development expenses in the periods in which they are incurred.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our lead product candidate, DNTH103, or any future product candidates.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our lead product candidate, claseprubart, DNTH212, or any other future product candidates.
If we enter into license or collaboration agreements for DNTH103 or any future product candidates or intellectual property, revenue may be generated in the future from such license or collaboration agreements.
If we enter into license or collaboration agreements for claseprubart, DNTH212, or any other future product candidates, if any, or intellectual property, revenue may be generated in the future from such license or collaboration agreements.
To the extent DNTH103 or any future product candidates continue to advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable.
To the extent claseprubart, DNTH212, or any other future product candidates advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable.
Cash Flows from Investing Activities For the year ended December 31, 2024, net cash used in investing activities consisted primarily of $413.7 million of purchases of investment securities, partially offset by $127.0 million of proceeds from maturities of investment securities.
For the year ended December 31, 2024, net cash used in investing activities consisted primarily of $413.7 million of purchases of investment securities and capital expenditures of $0.1 million, partially offset by $127.0 million of proceeds from sales and maturities of investment securities.
Any of these factors could significantly impact the costs, timing and viability associated with the development of DNTH103 or any future product candidates.
Any of these factors could significantly impact the costs, timing and viability associated with the development of claseprubart, DNTH212, or any other future product candidates.
The non-cash operating expenses consisted primarily of stock-based compensation expense of $12.9 million and amortization of right-of-use operating lease assets of $0.3 million, partially offset by accretion of discount on investment securities of $6.0 million and a gain on an investment in related party of $0.1 million.
The non-cash operating expenses consisted primarily of stock-based compensation expense of $22.8 million, amortization of right-of-use operating lease assets of $0.3 million and depreciation expense of $0.1 million, partially offset by accretion of discount on investment securities of $6.2 million and a gain on an investment in a former related party of $0.5 million.
A discussion regarding our financial condition and results of operations for the year ended December 31, 2023 compared to the year ended December 31, 2022 can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K filed with the SEC on March 21, 2024.
A discussion regarding our financial condition and results of operations for the year ended December 31, 2024 compared to the year ended December 31, 2023 can be found in “ Management’s Discussion and Analysis of Financial Condition and Results of Operations ” in our Annual Report on Form 10-K filed with the SEC on March 11, 2025.
This increase was due to: (1) a $37.1 million increase in external research and development costs, consisting of clinical operation activities, CMC activities, preclinical study costs, discovery expenses and license and milestone payments; and (2) a $13.2 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.
This increase was due to: (1) a $47.7 million increase in external research and development costs, consisting of clinical operation activities, CMC activities, preclinical study costs, discovery expenses and licensing and milestone payments; and (2) a $14.8 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.
The decrease in net operating assets and liabilities was primarily attributable to a decrease in receivable from Zenas of $4.4 million, a decrease in unbilled receivable from Zenas of $0.8 million, an increase in accounts payable, accrued expenses and lease liabilities of $0.7 million and a decrease in prepaid expenses and other current assets of $0.1 million, partially offset by an increase in other assets of $1.0 million and a decrease in deferred revenue of $0.1 million.
The decrease in net operating assets and liabilities was primarily attributable to increases in accounts payable, accrued expenses and operating lease liabilities of $11.3 million and deferred revenue of $4.6 million and decreases in receivables from Zenas of $0.8 million and other assets of $0.3 million, partially offset by increases in prepaid expenses and other current assets of $0.2 million and accounts receivable of $0.1 million.
The Tenacia Option (as described below) and Tenacia License Agreement are collectively referred to as the “Tenacia Agreements.” Under the Zenas License Agreement, Zenas also had the right to exercise an option with respect to a second antibody sequence, which is now held by Tenacia (the “Tenacia Option”).
Under the Zenas License Agreement, Zenas also had the right to exercise an option with respect to a second antibody sequence, which is now held by Tenacia (the “Tenacia Option” and, together with the Tenacia License Agreement, the “Tenacia Agreements”).
The Zenas License Agreement included the following payments from Zenas: (i) a non-refundable upfront payment of $1.0 million; (ii) an approximate $1.1 million payment representing reimbursement for a portion of development costs previously incurred by us; (iii) reimbursement of a portion of all CMC-related costs and expenses for the first antibody sequence through the manufacture of the first two batches of drug product; (iv) reimbursement of a portion of all non-CMC-related costs and expenses for the development of the first antibody sequence through the first regulatory approval; (v) development milestones totaling up to $11.0 million; and (vi) royalties on net sales ranging from the mid-single digits to the low teens. 77 Table of Contents On October 21, 2024, Zenas assigned the Zenas License Agreement to its affiliated entity, Zenas BioPharma (HK) Limited (“Zenas HK”).
The Zenas License Agreement included the following payments from Zenas: (i) a non-refundable upfront payment of $1.0 million; (ii) an approximately $1.1 million reimbursement payment for a portion of development costs previously incurred by us; (iii) reimbursement of a portion of all chemistry, manufacturing and control (“CMC”)-related costs and expenses for the first antibody sequence through the manufacture of the first two batches of drug product; (iv) reimbursement of a portion of all non-CMC-related costs and expenses for the development of the first antibody sequence through the first regulatory approval; (v) development milestones totaling up to $11.0 million; and (vi) royalties on net sales ranging from the mid-single digits to the low teen percentages.
The increase was primarily due to an increase of $12.6 million in interest income from a larger investment balance and higher interest rates on investments and a $0.1 million gain on an investment in a related party, partially offset by an increase in other expenses of $0.4 million.
The decrease was primarily due to a decrease of $1.3 million in interest income from a lower average investment balance and lower interest rates on investments and an increase of $0.4 million in other expense, partially offset by $0.4 million increased gain on an investment in a former related party.
Based on our current operating plan, we believe that our existing cash, cash equivalents and investments should be sufficient to fund our operations into the second half of 2027.
Based on our current operating plan, we believe that our existing cash, cash equivalents and investments as of December 31, 2025 should be sufficient to fund our operations into 2028.
Future Capital Requirements Since inception, we have not generated any revenue from product sales. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize DNTH103 or any future product candidates, and we do not know when, or if, that will occur.
We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize claseprubart, DNTH212, or any other future product candidates, and we do not know when, or if, that will occur.
For the year ended December 31, 2023, net cash used in operating activities consisted of a net loss of $43.6 million, partially offset by a decrease in net operating assets and liabilities of $4.9 million and net non-cash operating expenses of $1.8 million.
For the year ended December 31, 2024, net cash used in operating activities consisted of a net loss of $85.0 million and an increase in net operating assets and liabilities of $0.4 million, partially offset by net non-cash operating expenses of $7.1 million.
We have an open market sales agreement with TD Securities (USA) LLC (“TD Cowen”) (the “ATM Agreement”) pursuant to which, we may sell from time to time, through TD Cowen, shares of our common stock for an aggregate sales price of up to $200 million.
We have an open market sales agreement (the “ATM Agreement”) pursuant to which we may sell, from time-to-time shares of our common stock under an at-the-market (“ATM”) offering for an aggregate sales price of up to $200 million.
Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations and other comprehensive loss for the periods indicated: Year Ended December 31, 2024 2023 (in thousands) Revenues: License revenue - related party $ 5,909 $ 2,826 License revenue 326 — Total revenues 6,235 2,826 Operating expenses: Research and development 83,105 32,841 General and administrative 24,994 18,159 Total operating expenses 108,099 51,000 Loss from operations (101,864 ) (48,174 ) Other income/(expense): Interest income 17,365 4,764 Gain on investment in related party 148 — Loss on currency exchange, net (64 ) (85 ) Other expense (554 ) (60 ) Total other income 16,895 4,619 Net loss $ (84,969 ) $ (43,555 ) Revenues Under the terms of the Zenas Agreements, we recognized related party license revenue of $5.9 million and $2.8 million during the years ended December 31, 2024 and 2023, respectively.
Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations and other comprehensive loss for the periods indicated: Year Ended December 31, 2025 2024 (in thousands) Revenues: License revenue - former related party $ — $ 5,909 License revenue 2,036 326 Total revenues 2,036 6,235 Operating expenses: Research and development 145,638 83,105 General and administrative 34,331 24,994 Total operating expenses 179,969 108,099 Loss from operations (177,933 ) (101,864 ) Other income/(expense): Interest and investment income 16,119 17,365 Gain on investment in former related party 508 148 Loss on currency exchange, net (57 ) (64 ) Other expense (974 ) (554 ) Total other income 15,596 16,895 Net loss $ (162,337 ) $ (84,969 ) Revenues Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $5.9 million during the years ended December 31, 2025 and 2024, respectively.
Research and Development Expenses Research and development expenses were $83.1 million for the year ended December 31, 2024, as compared to $32.8 million for the year ended December 31, 2023, an increase of $50.3 million.
Research and Development Expenses Research and development expenses were $145.6 million for the year ended December 31, 2025, as compared to $83.1 million for the year ended December 31, 2024, an increase of $62.5 million.
For the year ended December 31, 2023, net cash provided by investing activities consisted primarily of $77.8 million of proceeds from maturities of investments, partially offset by $57.4 million of purchases of investments. 84 Table of Contents Cash Flows from Financing Activities For the year ended December 31, 2024, net cash provided by financing activities consisted of $215.3 million of net proceeds from the private placement, $39.2 million of net proceeds from the ATM offering program and $1.1 million of proceeds from the exercise of stock options.
For the year ended December 31, 2024, net cash provided by financing activities consisted of $215.3 million of net proceeds from the private placement, $39.2 million of net proceeds from the ATM offering program and $1.1 million of proceeds from the exercise of stock options.
Contractual Obligations and Commitments Lease Obligations We lease space under operating leases agreements for administrative offices in New York, New York, and Waltham, Massachusetts and wet laboratory space in Watertown, Massachusetts, which expire in February 2031, January 2026 and August 2025, respectively.
Contractual Obligations and Commitments Lease Obligations We lease administrative office space under operating lease agreements in New York, New York, and Waltham, Massachusetts, which expire in February 2031 and January 2027, respectively.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2024 2023 (in thousands) Net cash used in operating activities $ (78,180 ) $ (36,861 ) Net cash (used in)/provided by investing activities (286,812 ) 20,253 Net cash provided by financing activities 255,623 133,574 (Decrease)/increase in cash, cash equivalents and restricted cash $ (109,369 ) $ 116,966 Cash Flows from Operating Activities For the year ended December 31, 2024, net cash used in operating activities consisted of a net loss of $85.0 million and an increase in net operating assets and liabilities of $0.4 million, partially offset by net non-cash operating expenses of $7.1 million.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2025 2024 (in thousands) Net cash used in operating activities $ (129,060 ) $ (78,180 ) Net cash used in investing activities (122,833 ) (286,812 ) Net cash provided by financing activities 280,125 255,623 Increase/(decrease) in cash, cash equivalents and restricted cash $ 28,232 $ (109,369 ) Cash Flows from Operating Activities For the year ended December 31, 2025, net cash used in operating activities consisted of a net loss of $162.3 million, partially offset by net non-cash operating expenses of $16.5 million and a decrease in net operating assets and liabilities of $16.7 million.
Further, determining the standalone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, we consider relevant assumptions to estimate the standalone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success and forecasted revenues. 86 Table of Contents We evaluate the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determined whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract.
Further, determining the standalone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, we consider relevant assumptions to estimate the standalone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success and forecasted revenues.
Any sales of our common stock pursuant to the ATM Agreement are made under our registration statement on Form S-3 which was deemed effective by the SEC on October 9, 2024. During the quarter ended December 31, 2024, we sold 1,503,708 shares of our common stock and received net proceeds of $39.2 million.
Any sales of our common stock pursuant to the ATM Agreement are made under our registration statement on Form S-3 which was deemed effective by the SEC on October 9, 2024.
At the inception of each arrangement that includes variable consideration, we evaluate the amount of potential transaction price and the likelihood that the transaction price will be received. We utilize either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received.
We estimate the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. At the inception of each arrangement that includes variable consideration, we evaluate the amount of potential transaction price and the likelihood that the transaction price will be received.
The increased DNTH103-related costs were primarily due to activities related to the commencement of DNTH103’s Phase 2 clinical trials in gMG and MMN in 2024, along with the initiation of a Phase 3 clinical trial in CIDP in 2024. 81 Table of Contents The $13.2 million increase in internal research and development costs was due to increases of $7.1 million in personnel and related costs, $4.7 million in stock-based compensation expense and $1.4 million in other expenses.
The changes related to claseprubart’s ongoing Phase 2 clinical trials in gMG and MMN and Phase 3 clinical trial in CIDP. The $14.8 million increase in internal research and development costs was due to increases of $9.3 million in personnel and related costs, $4.5 million in stock-based compensation expense and $1.0 million in other expenses.
We cannot provide assurance that we will ever generate positive cash flow from operating activities. To date, we have funded our operations primarily with proceeds from the sale of capital stock and have raised aggregate gross proceeds of $423.5 million from private placements and net proceeds of $39.2 million from our ATM offering program.
We cannot provide assurance that we will ever generate positive cash flow from operating activities. Historically, we have funded our operations with proceeds from the sale of capital stock.
In addition to annual license fees, we are obligated to pay development milestones payments of up to $12.2 million and to pay royalties in the low to mid-single digit percentages. In July 2020, we entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities under our first development program.
In July 2020, we entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities under our first development program.
We are subject to all the risks involved in the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may harm our business. 82 Table of Contents In order to complete the development of DNTH103 or any future product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital.
In order to complete the development of claseprubart, DNTH212, or any other future product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital.
Additionally, we have not recorded any royalty revenue to date. For the years ended December 31, 2024 and 2023, we recognized related party license revenue totaling $5.9 million and $2.8 million, respectively, associated with the Zenas Agreements. For the year ended December 31, 2024, we recognized license revenue totaling $0.3 million related to the Tenacia License Agreement.
For the years ended December 31, 2025 and 2024, we recognized license revenue totaling $2.0 million and $0.3 million, respectively, associated with the Tenacia Agreements.
In the open label Part A of this trial, participants will be administered a loading dose followed by 300mg DNTH103 administered Q2W via S.C. injection for up to 13 weeks. Part A includes an interim responder analysis of the first 40 participants enrolled in Part A.
CAPTIVATE The CAPTIVATE trial is a single, two-part, randomized withdrawal global Phase 3 trial of claseprubart in patients with CIDP. In the open label Part A of this trial, participants will be administered claseprubart with a loading dose followed by 300mg/2mL administered Q2W via S.C. injection for up to 13 weeks.
We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of DNTH103 or any future product candidates or from license or collaboration agreements. We may never succeed in obtaining regulatory approval for DNTH103 or any future product candidates. Licensing Agreements In June 2022, we executed a license agreement with Zenas BioPharma, Inc.
We may never succeed in obtaining regulatory approval for claseprubart, DNTH212, or any other future product candidates. 78 Table of Contents Licensing Agreements In June 2022, we executed a license agreement with Zenas BioPharma, Inc.
Secondary endpoints include time to intravenous immunoglobulin (“IVIg”) retreatment, time to relapse, and assessments of muscle and grip strength. We anticipate initial top-line results from this trial to be available in the second half of 2026. Global and Macroeconomic Developments Uncertainty in the global economy presents significant risks to our business.
The initial S.C. treatment duration is 17 weeks followed by a 52-week OLE. The primary endpoint of this study is safety and tolerability. Secondary endpoints include time to intravenous immunoglobulin (“IVIg”) retreatment, time to relapse, and assessments of muscle and grip strength. We anticipate initial top-line results from this trial to be available in the second half of 2026.
We are obligated to pay development and commercial milestone payments of up to £5.4 million (approximately $6.8 million based on the December 31, 2024 exchange rate) with the first development program and of up to £2.5 million (approximately $3.1 million based on the December 31, 2024 exchange rate) with the second development program. 85 Table of Contents Critical Accounting Policies and Estimates Our financial statements are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
In addition to annual license fees, we are obligated to pay development and commercial milestone payments of up to $12.8 million for the first partnered antibody, which has been selected for the claseprubart program. Critical Accounting Policies and Estimates Our financial statements are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
The increases were due to the buildout of our internal research and development function to support our Phase 2 and Phase 3 clinical trials. General and Administrative Expenses General and administrative expenses were $25.0 million for the year ended December 31, 2024, as compared to $18.2 million for the year ended December 31, 2023, an increase of $6.8 million.
General and Administrative Expenses General and administrative expenses were $34.3 million for the year ended December 31, 2025, as compared to $25.0 million for the year ended December 31, 2024, an increase of $9.3 million.
Overview We are a clinical-stage biotechnology company focused on developing next-generation complement therapeutics for patients living with severe autoimmune and inflammatory diseases.
Overview We are a clinical-stage biotechnology company dedicated to developing potentially best-in-class therapies for patients living with severe autoimmune diseases.
The increases in costs were due to the buildout of our general and administrative function to support our operations as a public company and to support our Phase 2 and Phase 3 clinical trials.
The increases were due to the 82 Table of Contents buildout of our internal research and development function to support our Phase 2 and Phase 3 clinical trials in claseprubart and development of DNTH212.
We believe our lead novel and proprietary monoclonal antibody product candidate, DNTH103, has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in efficacy, safety, and/or dosing convenience.
Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. We believe claseprubart has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in efficacy, safety, and/or dosing convenience.
These increases were partially offset by a decrease in personnel-related costs of $1.4 million related to severance costs to former employees of Magenta in the prior period. Other Income/(Expense) Other income was $16.9 million for the year ended December 31, 2024, as compared to $4.6 million for the year ended December 31, 2023, an increase of $12.3 million.
Other Income/(Expense) Other income was $15.6 million for the year ended December 31, 2025, as compared to $16.9 million for the year ended December 31, 2024, a decrease of $1.3 million.
We are currently enrolling patients in three mid- to late-stage clinical trials with DNTH103 in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”). MAGIC The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study of DNTH103 in up to 60 patients with gMG who are acetylcholine receptor antibody positive.
We are currently conducting three mid- to late-stage clinical trials with claseprubart in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”).
For the year ended December 31, 2024, as compared to the year ended December 31, 2023, there were increases in expenses related to DNTH103 of $20.9 million in clinical operations activities, $13.5 million in CMC activities, $1.5 million in preclinical study costs and $0.5 million in license and milestone payments.
The increase in expenses related to claseprubart were due to increases of $24.1 million in clinical operations activities and $1.5 million in licensing and milestone payments, partially offset by decreases of $4.9 million in preclinical study costs and $3.0 million in CMC activities.
Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or DNTH103 administered Q2w via S.C. injection. The initial S.C. treatment duration is expected to be 17 weeks followed by a 52-week open label extension. The primary endpoint of this study is safety and tolerability.
Following an initial loading dose, claseprubart was administered every two weeks (“Q2W”) via S.C. injection at a dose of 300mg/2mL or 600mg/4mL. The initial randomized treatment duration was 13 weeks, followed by a 52-week open-label extension (“OLE”). The primary endpoint of the study was safety and tolerability.
The economic terms with respect to this second antibody sequence were unchanged by the amendment to the Zenas License Agreement.
The economic terms with respect to this second antibody sequence were unchanged by the amendment to the Zenas License Agreement. For the years ended December 31, 2025 and 2024, we recognized related party license revenue totaling nil and $5.9 million, respectively, associated with the Zenas Agreements.
The increase was primarily due to increases of $5.3 million in stock-based compensation expense, $1.5 million in professional services costs, $1.0 million in third-party consulting services costs and $0.4 million in facilities costs.
The increase was primarily due to increases of $5.4 million in stock-based compensation expense, $3.3 million in personnel and related costs and $0.6 million in other administrative costs. The increases in costs were due to the buildout of our general and administrative function to support our Phase 2 and Phase 3 clinical trials in claseprubart and development of DNTH212.
We also recognized license revenue of $0.3 million for the year ended December 31, 2024 related to the Tenacia License Agreement, which was executed in October 2024.
Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $2.0 million and $0.3 million for the years ended December 31, 2025 and 2024, respectively.
The $37.1 million increase in external research and development costs was due to a $36.4 million increase in expenses related to our lead product candidate, DNTH103, and a $0.7 million increase related to discovery expenses.
The $47.7 million increase in external research and development costs was due to a $30.0 million increase in expenses related to discovery activities and a $17.7 million increase in expenses related to claseprubart. The increase in discovery activities related primarily to the upfront and clinical development milestone payments of $30.0 million for the DNTH212 program.
Goods or services that meet these criteria are considered distinct performance obligations. We estimate the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration.
We evaluate the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determine whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. Goods or services that meet these criteria are considered distinct performance obligations.
We believe that this single pivotal trial will support a BLA filing in adult patients with CIDP.
In March 2026, we announced that we achieved our target of 20 confirmed responders in Part A early, with less than 40 participants completing Part A. We believe that this single pivotal trial will support a Biologics License Application (“BLA”) filing in adult patients with CIDP.
We anticipate completing an interim responder analysis of the first 40 participants in Part A in the second half of 2026. 76 Table of Contents MOMENTUM The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of DNTH103 in 36 patients with MMN.
MOMENTUM The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of claseprubart in 36 patients with MMN. Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or claseprubart with a loading dose followed by 300mg/2mL or 600mg/4mL administered Q2W via S.C. injection.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitati ve and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined by Rule 12b-2 under the Exchange Act and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item. 87 Table of Contents
Biggest changeItem 7A. Quantitati ve and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined by Rule 12b-2 under the Exchange Act and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item. 88 Table of Contents

Other DNTH 10-K year-over-year comparisons