CLYM

The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Risks Related to our Financial Position and Need for Additional Capital We have incurred significant losses since our inception, expect to continue to incur substantial losses for the foreseeable future and may never achieve or sustain profitability.
Our efforts are focused primarily on the treatment of unmet needs in immune-mediated diseases.
We are initially developing our lead product candidate budoprutug in pMN, ITP and SLE.
In addition, in January 2025, we expanded our pipeline of B-cell targeted therapeutics by entering into the Mabworks Agreement, pursuant to which Mabworks granted us licenses to develop, manufacture and commercialize CLYM116, an anti-APRIL mAb, and products containing CLYM116.
To date, we have not received regulatory approvals for any of our product candidates or generated any revenue from product sales.
We do not expect to generate revenue from product sales for the foreseeable future.
As a result, we are not profitable, and we have incurred significant operating losses since inception and expect to continue to incur substantial losses, including expenses incurred to advance the development of budoprutug and CLYM116, conduct clinical trials, pursue regulatory approvals, maintain, expand, and protect our intellectual property portfolio, operate as a public company, potentially acquire or in-license other technologies, and build the capabilities necessary for potential commercialization of our product candidates, if approved.
Our net loss was $59.9 million for the year ended December 31, 2025, and as of December 31, 2025, we had an accumulated deficit of $289.7 million.
We may never achieve or sustain profitability.
If we are unable to access capital when needed, it could force us to delay, reduce or terminate our product candidate development programs, commercialization efforts, or other operations.
Conducting nonclinical studies and clinical trials, obtaining regulatory approvals, and preparing for potential commercialization are costly, time-consuming, and subject to significant uncertainty.
As of December 31, 2025, we had cash, cash equivalents and marketable securities of $160.7 million.
Based on our current operating plan and assumptions, we believe our existing capital resources will be sufficient to fund our operations into 2028.
In addition, our operating plan may change, and we may require additional capital sooner than anticipated.
Our future need for additional funding depends on many factors, including: • the number and scope of development, nonclinical and clinical programs we decide to pursue, and the timing, cost and progress of activities related to such programs; • the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE, our Phase 1 clinical trial of the SC formulation of budoprutug, our Phase 1 clinical trial of CLYM116, and any future clinical trials of our product candidates; • the costs of manufacturing our product candidates by third parties; • the terms of any collaborations, license or research and development agreements we may enter into; • the cost of regulatory requirements, regulatory submissions and timing of regulatory approvals; • the costs involved in prosecuting and enforcing patent and other intellectual property claims; • the potential delays in our development programs and clinical trial activities due to the effects of global events, including macroeconomic conditions and supply chain disruptions; • the impact of inflationary pressures on salaries and wages, and costs of goods and transportation expenses, including the impact of tariffs and other trade restrictions; • the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs; and • our efforts to enhance operational systems and hire personnel to support the development of our product candidates.
Our ability to raise additional capital may be adversely impacted by disruptions to, or continuing volatility in, the credit and financial markets in the U.S. and worldwide, including increased volatility in the trading prices for shares of public companies in the biopharmaceutical sector, actual and perceived changes in interest rates and inflation, macroeconomic uncertainties, or otherwise.
To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, our stockholders’ ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of a common stockholder.
For example, we issued additional shares of our common stock in connection with the Acquisition, as well as in the concurrent private placement of shares of our common stock to certain institutional investors (Private Placement).
Our ability to generate revenue also depends on a number of additional factors, including our or any current or future collaborators’ ability to: • complete and submit INDs to the FDA that allow commencement of clinical trials for our product candidates; • complete development activities, including the necessary clinical trials; • complete and submit BLAs to the FDA and obtain regulatory approval for indications for which there is a commercial market; • complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities; • set a commercially viable price for any products; • establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply; • develop a commercial organization capable of sales, marketing and distribution for any products for which we obtain marketing approval and intend to sell ourselves in the markets in which we choose to commercialize on our own; • find suitable distribution partners to help us market, sell and distribute our approved products in other markets; • obtain coverage and adequate reimbursement from third-party payors, including government and private payors; • achieve market acceptance for any products; • establish, maintain and protect our intellectual property rights; and • attract, hire and retain qualified personnel.
Even if we can generate revenue from the sale of any of our product candidates that may be approved, we may not become profitable.
We may be required to make significant payments in connection with our license agreements, which could strain our capital resources.
We may be required to make significant payments under our license and asset purchase agreements, including development, regulatory, commercial and sales‑based milestone, and royalty payments.
These obligations may be substantial and strain our capital resources, and we may not have sufficient funds when payments become due.
If we fail to meet payment or diligence obligations, licensors may terminate the agreements, resulting in the loss of rights to budoprutug, CLYM116 or any other product candidate we may license.
As a result of the Acquisition, certain legacy Tenet agreements effectively became agreements of ours, including the Asset Purchase Agreement, the CRH Agreement, and the ProBioGen Agreement.
In addition, in January 2025, we entered into the Mabworks Agreement, pursuant to which we obtained licenses to develop, manufacture and commercialize CLYM116, and products containing CLYM116, in certain territories.
We may be obligated to make significant future payments under these agreements, including obligations to pay certain contingent development, commercial, sales and regulatory milestones and royalties, as well as other obligations, as applicable.
Certain of these agreements set forth specific development, regulatory and commercial events, the occurrence of which would result in related payments that we would be obligated to make.
Risks Related to our Business and the Development of our Product Candidates Our future success is dependent on the regulatory approval and commercialization of our product candidates, and if we are unable to successfully develop and commercialize our product candidates, or experience any delay in doing so, our business could be materially harmed.
Our future success depends on developing our product candidates, obtaining regulatory approval and successfully commercializing our product candidates.
Delays or failures in clinical development, regulatory review, or commercialization could prevent or delay us from generating revenue or achieving profitability.
Regulatory approval processes are lengthy, complex, and inherently uncertain, and regulatory expectations may evolve during development.
As a result, our prospects, including our ability to finance our operations and generate revenue, are dependent on our ability to obtain regulatory approval for budoprutug and CLYM116, and, if approved, to successfully commercialize budoprutug and CLYM116.
Under the PDUFA, the FDA’s standard review process for a BLA is meant to take 10 months from the date a BLA is accepted for filing, but that process may take longer to complete, and FDA approval is never guaranteed.
Before obtaining regulatory approvals for the commercial sale of our product candidates for a target indication, we must demonstrate with substantial evidence gathered in nonclinical and well-controlled clinical trials, and, with respect to approval in the U.S., to the satisfaction of the FDA, that the product candidate is potent, safe and pure for use for that target indication and that the manufacturing facilities, processes and controls are adequate.
Additionally, pediatric studies may be required pursuant to PREA or comparable foreign requirements.
Even if approved, our products may be subject to post‑approval requirements, limitations on use, labeling changes, safety monitoring, or withdrawal or changes in law, guidance, or waiver from the FDA.
A deferral of the requirement to conduct pediatric studies may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety, potency and purity data need to be collected before the pediatric trials begin.
The applicable legislation in the EU also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the EMA or to obtain a waiver or deferral from the conduct of these studies by this Committee.

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Gone since FY2024

Risk Factors The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Risks Related to our Financial Position and Need for Additional Capital We have incurred significant losses since our inception and anticipate that we will incur substantial losses for the foreseeable future and may never achieve or maintain profitability.
Our efforts are focused primarily on the treatment of unmet needs in immune-mediated diseases, in particular the development of budoprutug.
We are initially developing budoprutug in primary membranous nephropathy (pMN), immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE).
In addition, on January 8, 2025, we expanded our pipeline of B-cell targeted therapeutics to address immune-mediated diseases by entering into a technology transfer and exclusive license agreement (the Mabworks Agreement) with Beijing Mabworks Biotech Co., Ltd.
(Mabworks), pursuant to which Mabworks granted us licenses to develop, manufacture and commercialize CLYM116, an anti-APRIL (A PRoliferation-Inducing Ligand) monoclonal antibody, and products containing CLYM116.
To date, we have not received regulatory approvals for any of our product candidates or generated any revenue from the sale of products, and we do not expect to generate any revenue for the foreseeable future.
As a result, we are not profitable, and we have incurred significant operating losses since inception.
Our net losses were $73.9 million and $35.1 million for the years ended December 31, 2024 and 2023, respectively.
We had an accumulated deficit of $229.9 million and $156.0 million as of December 31, 2024 and 2023, respectively.
We expect to continue to incur substantial expenses and operating losses for the foreseeable future as we continue to develop our product candidates.
As a result, we expect to continue to incur significant losses for the foreseeable future as we: • initiate and continue research and development, including preclinical, clinical and discovery efforts for our product candidates; • conduct ongoing and future clinical trials of our product candidates; • seek regulatory approvals for our product candidates that successfully complete clinical development; • incur legal, accounting, or other expenses in operating our business; • hire and retain qualified personnel, including to expand our general and administrative functions to support our future growth; • maintain, expand and protect our intellectual property portfolio; • establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure in the future to commercialize various products for which we may obtain regulatory approval; and • acquire or in-license other product candidates and technologies.
We may be required to make significant payments to Mabworks in connection with the Mabworks Agreement.
Pursuant to the Mabworks Agreement, we acquired (1) an exclusive (even as to Mabworks and its affiliates), sublicensable right and license under certain patent rights and related know-how (the Licensed Intellectual Property) to develop, manufacture and commercialize Mabworks’ proprietary antibodies associated with CLYM116 and products containing CLYM116 (Licensed Products) outside of mainland China, Hong Kong, Macau, and Taiwan, which we collectively refer to as Greater China, (2) a non-exclusive, sublicensable right and license under the Licensed Intellectual Property to manufacture CLYM116 and Licensed Products in Greater China (the Licensed Territory) and (3) a non-exclusive, sublicensable right and license under the Licensed Intellectual Property to develop CLYM116 and Licensed Products in Greater China in connection with certain global clinical studies.
Under the Mabworks Agreement, we are subject to significant potential future obligations, including payment of development and regulatory milestones and royalties on net product sales, as well as other obligations.
The Mabworks Agreement sets forth specific development, regulatory and commercial events and the related payments that we would be obligated to make to Mabworks, if and when such events occur.
For additional information on the terms of the Mabworks Agreement, please refer to Part 1, Item 1 of this Annual Report on Form 10-K under the section titled “License Agreements”.
If we are unable to access capital when needed, it could force us to delay, reduce or terminate our product development programs, commercialization efforts, or other operations.
We had cash, cash equivalents and marketable securities of $212.5 million and $106.8 million at December 31, 2024 and 2023, respectively.
Based upon our current operating plan and assumptions, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations through 2027.
In addition, we will need additional capital to advance and expand our research pipeline, conduct preclinical studies and clinical trials, proceed to develop and commercialize any approved products, and explore other pipeline opportunities.
Our estimates of the sufficiency of our cash, cash equivalents and marketable securities are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect.
Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
Conducting preclinical studies and clinical trials, pursuing regulatory approvals, establishing outsourced manufacturing relationships and successfully manufacturing and commercializing our product candidates is, and will be, very time-consuming, expensive and an uncertain process that takes years to complete.
Our future need for additional funding depends on many factors, including: • the timing, cost and progress of our research, preclinical, and clinical development activities; • the progress, costs and results of our clinical trials of budoprutug in pMN, ITP, and SLE and any future clinical trials of our product candidates; • the number and scope of development, preclinical and clinical programs we decide to pursue; • the terms of any collaborations and/or research and development agreements we may enter into, which may impact the cost, timing and development plans for our product candidates; • the costs involved in prosecuting and enforcing patent and other intellectual property claims; • the costs of manufacturing our product candidates by third parties; • the cost of regulatory requirements, regulatory submissions and timing of regulatory approvals; • the potential delays in our preclinical studies, our development programs and our ongoing and planned clinical trial activities due to the effects of global events, including macroeconomic conditions and continued supply chain disruptions; • the impact of inflationary pressures on salaries and wages, and costs of goods and transportation expenses, among other things; • the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs; and • our efforts to enhance operational systems and hire personnel to support the development of our product candidates.
Our ability to raise additional capital may be adversely impacted by disruptions to, or continuing volatility in, the credit and financial markets in the United States (U.S.) and worldwide, including increased volatility in the trading prices for shares of public companies in the biopharmaceutical sector, actual and perceived changes in interest rates and inflation, macroeconomic uncertainties, or otherwise.
To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a common stockholder.
We may be forced to obtain additional capital before reaching clinical or regulatory milestones, when our stock price or trading volume or both are low, or when the general market for life sciences companies is weak.
Raising capital under any of these or similar scenarios, if we can raise any at all, may lead to significant dilution to our existing stockholders.
For example, we issued additional shares of our common stock in connection with our acquisition of Tenet Medicines, Inc.
(the Acquisition), as well as in the concurrent private placement of shares of our common stock to certain institutional investors.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete.
We may never generate the necessary data or results required to obtain marketing approval for our product candidates or generate revenue from the sale of any products for which we may obtain marketing approval.
Our ability to generate revenue also depends on a number of additional factors, including our or any future collaborators’ ability to: • complete and submit investigational new drug applications (INDs) to the U.S.
Food and Drug Administration (FDA) that allow commencement of our planned clinical trials or future clinical trials for our product candidates; • complete development activities, including the necessary clinical trials; • complete and submit biologics license applications (BLAs) to the FDA and obtain regulatory approval for indications for which there is a commercial market; • complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities; • set a commercially viable price for any products; • establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply; • develop a commercial organization capable of sales, marketing and distribution for any products for which we obtain marketing approval and intend to sell ourselves in the markets in which we choose to commercialize on our own; • find suitable distribution partners to help us market, sell and distribute our approved products in other markets; • obtain coverage and adequate reimbursement from third-party payors, including government and private payors; • achieve market acceptance for any products; • establish, maintain and protect our intellectual property rights; and • attract, hire and retain qualified personnel.
Even if we can generate revenues from the sale of any of our product candidates that may be approved, we may not become profitable and may need to obtain additional funding to continue operations.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
Risks Related to our Business and the Development of our Product Candidates Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates.
As a result, our prospects, including our ability to finance our operations and generate revenue, are substantially dependent on our ability to obtain regulatory approval for budoprutug and CLYM116, and, if approved, to successfully commercialize budoprutug and CLYM116.
Under the Prescription Drug User Fee Act, the FDA’s standard review process for a BLA is meant to take 10 months from the date a BLA is accepted for filing, but that process may take longer to complete and FDA approval is never guaranteed.

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