CRBP 10-K & 10-Q changes, risk factors and insider trading

An investment in our common stock is highly speculative and illiquid and involves a high degree of riskrisk, including the risk of a loss of your entire investment. You should carefully consider the risks and uncertainties described below and the other information contained in this report and our other reports filed with the Securities and Exchange Commission. The risks set forth below are not the only ones facing us. Additional risks and uncertainties may exist that could also adversely affect our business, operations and financial condition. If any of the following risks actually materialize,occur, our business, financial conditioncondition, and/orresults of operations could suffer. In such event, the value of our commonand stock could decline, and youprice could losebe allmaterially oradversely a substantial portion of the money that you pay for our common stock.affected.

We are a biopharmaceutical company with a limited operating history. All our product candidates that we do not intend to out-license are in the discovery stage, pre-clinical, or clinical development stage. We must complete clinical studies and other development activity and receive regulatory approval of ana NDAmarketing or BLAapplication before commercial sales of a product can commence. The likelihood of success of our business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate. Pharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.

On May 31, 2023, we entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (the “Open Market Sale Agreement”) with Jefferies LLC (“Jefferies”) pursuant to which Jefferies is serving as the sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of itsour common stock having an aggregate offering price of up to $150.0 million (the “2024 Open Market Offering”). For the year ended December 31, 2024,2025, we have sold an aggregate of 2,484,517563,504 shares of common stock for net proceeds of approximately $91.4$7.0 million under the Open Market Sale Agreement. As of December 31, 2024,2025, approximately $76.4$69.1 million is available for issuance and sale under the 2024 Open Market Offering.

On JanuaryOctober 31,30, 2024,2025, we entered into an underwriting agreement with Jefferies, as representative (the “"Representative”") of the several underwriters (the “"Underwriters”"), relating to an underwritten public offering of 4,325,0004,744,231 shares of our common stock,stock at a price to the public of $19.00$13.00 per shareshare, ("Januaryand, 2024to Publiccertain Offering").investors Thein Underwriterslieu wereof alsocommon grantedstock, apre-funded 30-day optionwarrants to purchase up to an additional 648,7501,025,000 shares of common stock at thea public offering price.price of $12.9999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. On JanuaryNovember 31,3, 2024, the Representative gave notice of the Underwriters’ election to exercise the option to purchase additional shares, in full. On February 2, 2024,2025, we completed the public offering raising gross proceed of approximately $94.5 million and net proceeds of $88.6$70.2 million after deducting underwriting discounts and commissions and other offering expenses payable by us.

CRB-701 is currently in a Phase 1/2 dosestudy expansionin the U.S. and Europe conducted by us (referred to herein as the Western study) and a Phase 3 clinical trial being conducted in China by CSPC (referred to herein as the China study). andCRB-913 is currently in a corresponding Phase 11b dosestudy optimizationbeing clinical trialconducted in the U.S. and U.K. conducted by us (referred to herein as the Western study). We are also planning to expand the Western study by adding additional clinical sites in Europe during 2025. CRB-601 is currently in a Phase 1 clinical trial being conducted in the U.S. with expansion planned in 2025 into theand U.K. We have completed initial pre-clinical testing for CRB-913 and expect to commence a Phase 1 clinical trial in the first quarter of 2025. We note that most drug candidates never reach the clinical development stage and even those that do have only a small chance of successfully completing clinical development and gaining regulatory approval.

Our pre-clinical and clinical trials may be unsuccessful, which would materially harm our business. Even if our initial trials are successful, we will be required to conduct additional trials to establish the safety and efficacy of our drug candidates before anmarketing NDA or BLAapplication can be filed with the FDA for marketing approval of any of our drug candidates.

Drug testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results. A failure of one or more of our trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, the drug testing process that could delay or prevent our ability to receive regulatory approval or commercialize our drug candidates. The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries, which regulations differ from country to country. We are not permitted to market any of our drug candidates as prescription pharmaceutical products in the U.S. until we receive approval of ana NDAmarketing or BLAapplication from the FDA or in foreign markets until we receive the requisite approval from comparable regulatory authorities in such countries. In the U.S., the FDA generally requires the completion of pre-clinical and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before ana NDAmarketing or BLAapplication is approved. Regulatory authorities in other jurisdictions impose similar requirements. Of the large number of drugs in development, only a small percentage result in the submission of ana NDAmarketing or BLAapplication to the FDA and even fewer are eventually approved for commercialization. We have never submitted anmarketing NDA or BLAapplication to the FDA or any comparable applications to other regulatory authorities. If our development efforts for our drug candidates, including regulatory approval, are not successful for our planned indications, or if adequate demand for our drug candidates is not generated, our business will be harmed.

the data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA, or other submission or to obtain regulatory approval in the U.S. or elsewhere (collectively, “marketing application”);

Under the Federal Food, Drug, and Cosmetic Act, our products cannot be investigated in humans or marketed without approval from FDA. In addition, companies developing new therapies routinely seek and receive guidance from FDA regarding their methods and plans for developing their products. We and companies like us may also benefit from FDA-administered programs like orphan drug designation and expedited development pathways, e.g., breakthrough designation. Any material reductions in the ability of FDA to perform these and other functions may delay development and approval of our product candidates. Recent actions by the United States federal government have caused concern in the industry that this may occur. For example, beginning on February 13, 2025, the Department of Health and Human Services began firing a large number of its probationary employees, a category that includes new federal employees and employees recently promoted or transferred to new positions or agencies. Larger layoffs may follow, according to a memorandum issued by the Office of Personnel Management on February 26, 2025. These terminations, if they withstand legal challenges, may significantly delay and impede our interactions with the FDA. Similar results may stem from the recent confirmed resignations of some senior FDA employees with responsibility for regulation of drugs and biologics, as well as possible future layoffs and resignations. There are also reports that the United States federal government intends to request Congress to reduce FDA funding in upcoming budgets. Such funding cuts may also delay the development and approval of our products.

Drug testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Our drug candidates are in various stages of discovery, pre-clinical, and clinical testing. Pre-clinical tests are performed at an early stage of a product's development and provide information about a drug candidate's safety and effectiveness on laboratory animals. Pre-clinical tests can last years. If a product passes its pre-clinical tests satisfactorily and we determine that further development is warranted, we would file an IND application for the product with the FDA, and if the FDA gives its approval, we would begin Phase 1 clinical tests. IfAlthough drug candidates can take various paths, generally if Phase 1 test results are satisfactory and the FDA gives its approval, we can begin Phase 2 clinical tests. If Phase 2 test results are satisfactory and the FDA gives its approval, we can begin Phase 3 pivotal studies. Once clinical testing is completed and ana NDAmarketing or BLAapplication is filed with the FDA, it may take more than a year to receive FDA approval.

As product candidates proceed through preclinicalpre-clinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials.

Formulation and manufacturing of biologic products such as ours is complex and expensive. Our BLAsmarketing applications must include information about the chemistry and physical characteristics of our products, and we must demonstrate that we have a reliable process for manufacturing the products in commercial quantities in accordance with FDA’s current cGMP requirements. The manufacturing process must consistently produce quality batches of the biologic, and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate the effectiveness of the packaging and that the compound does not undergo unacceptable deterioration over its shelf life. If we are unable to successfully complete any of these complex steps, approval of our biologic may be delayed or denied.

In addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our drug candidates successfully. For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance. Any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render our drug candidates not commercially viable. For example, regulatory authorities may approve our drug candidates for fewer or more limited indications than we request, may not approve the prices we intend to charge for our drug candidates, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve our drug candidates with labels that do not include the labeling claims necessary or desirable for the successful commercialization of a particular indication. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and a Risk Evaluation and Mitigation Strategy, or REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDAmarketing or BLAapplication must submit a proposed REMS; the FDA will not approve the NDAmarketing or BLAapplication without an approved REMS, if required. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our drug candidates. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of our drug candidates.

Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing and making a drug available in the U.S. for this type of disease or condition will be recovered from sales of the product. Orphan drug designation must be requested before submitting ana NDAmarketing or BLA.application. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan designation does not convey any advantage in or shorten the duration of regulatory review and approval process. In addition to the potential period of exclusivity, orphan designation makes a company eligible for grant funding of up to $0.4 million per year for four years to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA application user fee.

Our collaboration partners are currently conducting and may intend in the future to conduct clinical trials outside the U.S., particularly in China where CSPC is conducting atheir Phaseown 1clinical trial.trials. Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of these data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted by qualified investigators in accordance with cGCPs, including review and approval by an independent ethics committee and receipt of informed consent from trial patients. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. Generally, the patient population for any clinical trial conducted outside of the U.S. must be representative of the population for which we intend to seek approval in the U.S. In addition, while these clinical trials are subject to applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also comply with all applicable U.S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the U.S. If the FDA does not accept the data from our clinical trials conducted outside the U.S., it would likely result in the need for additional clinical trials, which would be costly and time-consuming and delay or permanently halt our ability to develop and market these or other drug candidates in the U.S. In addition, there are risks inherent in conducting clinical trials in jurisdictions outside the U.S. including:

We are a party to a license agreement with CSPC pursuant to which we licensed the exclusive rights in the U.S., Canada, the European Union (including the European Free Trade Area), the U.K., and Australia to develop and market a drug candidate from CSPC. This agreement is important to our business, and we may enter into additional license agreements in the future. Certain of our in-licensed intellectual property covers, or may cover, potential antibodies, monoclonal antibody, and antibody drug conjugate developmental candidates. Our existing license agreement imposes, and we expect that future license agreements will impose, various diligence, milestone payment, royalty, and other obligations on us. If there is any conflict, dispute, disagreement or issue of non-performance between us and our licensing partners regarding our rights or obligations under the license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement, we may owe damages, our licensor may have a right to terminate the affected license, and our ability to utilize the affected intellectual property in our product discovery and development efforts and our ability to enter into collaboration or marketing agreements for an affected product candidate may be adversely affected.

If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. In addition, the loss of the services of certain key employees, including Yuval Cohen, our Chief Executive Officer, Sean Moran, our Chief Financial Officer, and Dominic Smethurst, our Chief Medical Officer,employees would adversely impact our business prospects.

Our management team has expertise in many different aspects of drug development and commercialization. However, we will need to hire additional personnel as we further develop our drug candidates. Competition for skilled personnel in our market is intense and competition for experienced scientists may limit our ability to hire and retain highly qualified personnel on acceptable terms. Despite our efforts to retain valuable employees, members of our management, scientific and medical teams may terminate their employment with us on short notice. We have entered into employment agreements with certain of our executive officers. However, these employment arrangements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. The loss of the services of any of our executive officers or other key employees could potentially harm our business, operating results, or financial condition. In particular, we believe that the loss of the services of Yuval Cohen, Ph.D., our Chief Executive Officer, Sean Moran, C.P.A., M.B.A., our Chief Financial Officer, and Dominic Smethurst, MA MRCP, our Chief Medical Officer, would have a material adverse effect on our business. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level, and senior managers as well as junior, mid-level, and senior scientific and medical personnel.

Our operations and performance depend, in part, on global and regional economic and geopolitical conditions, given our current third-party license agreement with CSPC, which is headquartered in China.China, and our reliance on global suppliers. Changes in U.S.-China trade policies, including the proposed BIOSECURE bill, and a number of other economic and geopolitical factors both in China and abroad could have a material adverse effect on our business, financial condition, results of operations or prospects. Such factors may include:

expanded jurisdiction of the Committee for Foreign Investment in the U.S. (CFIUS); and intergovernmental conflicts or actions, such as armed conflict, trade wars, retaliatory tariffs, and acts of terrorism or war.

As of December 31, 2024,2025, we had outstanding options to purchase an aggregate of 723,1531,386,020 shares of our common stock at a weighted average exercise price of $62.95$37.40 per share, 259,488498,543 shares of common stock issuable upon the vesting of restricted stock units, pre-funded warrants to purchase 1,025,000 shares of our common stock at an exercise price of $0.0001 per share and warrants to purchase an aggregate of 36,2072,873 shares of our common stock at a weighted average exercise price of $381.14$208.80 per share. The exercise of such outstanding options and warrants and vesting of restricted stock units will result in further dilution of your investment. If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. In recent years, many changes have been made to applicable tax laws and changes are likely to continue to occur in the future. For example, the Tax Act made significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%; limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small businesses); and, subject to certain changes in tax law made by the CARES Act as discussed above, limitation of the deduction of net operating losses generated in tax years beginning after December 31, 2017 to 80% of taxable income, indefinite carryforward of net operating losses generated in tax years after 2018 and elimination of net operating loss carrybacks generated in tax years ending after December 31, 2017; changes in the treatment of offshore earnings regardless of whether they are repatriated; current inclusion in U.S. federal taxable income of certain earnings of controlled foreign corporations, mandatory capitalization of research and development expenses beginning in 2022; immediate deductions for certain new investments instead of deductions for depreciation expense over time; further deduction limits on executive compensation; and modifying, repealing and creating many other business deductions and credits, including the reduction in the orphan drug credit from 50% to 25% of qualifying expenditures. We continue to examine the impact this tax reform legislation may have on our business. Notwithstanding the reduction in the corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could be adversely affected. The impact of this tax reform on holders of our common stock is also uncertain and could be adverse. This periodic report does not discuss any such tax legislation or the manner in which it might affect us or our stockholders in the future. We urge our stockholders to consult with their legal and tax advisors with respect to such legislation.

Notwithstanding the reduction in the corporate income tax rate, the overall impact of the Tax Act, the OBBBA and other tax reform legislation is uncertain and our business and financial condition could be adversely affected. The impact of this tax reform on holders of our common stock is also uncertain and could be adverse. This periodic report does not discuss any such tax legislation or the manner in which it might affect us or our stockholders in the future. We urge our stockholders to consult with their legal and tax advisors with respect to such legislation. It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our shareholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

We are ana clinical stage company focused on promising new therapies in oncology and obesity company with a diversified portfolio and are committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors:includes CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of monomethyl auristatin E ("MMAE") and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity.

CRB-701 (SYS6002) is a next-generation clinical stage ADC that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload of MMAE. In February 2023, we obtained a license from CSPC Megalith Biopharmaceutical Co. Ltd. ("“CSPC"”), a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize the drug in the United States (“U.S.”), Canada, the European Union (including the European Free Trade Area), the United Kingdom (“U.K.”) and Australia. We are conducting a Phase 1/2 study in the U.S. and Europe (the "Western study") enrolling patients with advanced solid tumors associated with Nectin-4 expression. The dose expansion phase of the clinical trial is ongoing. In June 2025, we began dosing participants in the PD-1 combination arm with CRB-701 in combination with Keytruda® (pembrolizumab). We received fast track designation for CRB-701 from the U.S. Food and Drug Administration (the "FDA") for the treatment of relapsed or refractory metastatic cervical cancer in December 2024 and in recurrent or metastatic head and neck squamous cell carcinoma (“HNSCC”) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy in September 2025. CRB-701 is currently being investigated by CSPC in a Phase 1 dose expansion3 clinical trial in patients with advancedcervical solid tumorscancer in China (the "China study"). We commenced a corresponding Phase 1 dose escalation study in the U.S. and the U.K. (the "Western study") in April 2024 and completed enrollment of the dose escalation phase in October 2024. The dose optimization portion in the Western study is currently ongoing and we are in the process of adding additional clinical sites in Europe. Both studies are enrolling patients with advanced solid tumors associated with Nectin-4 expression.

We are ana clinical stage company focused on promising new therapies in oncology and obesity company and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at December 31, 2024,2025, we had an accumulated deficit of approximately $476.9$555.4 million. Our net losses for the years ended December 31, 20242025 and 20232024 were approximately $40.2$78.5 million and $44.6$40.2 million, respectively.

Research and development activities are the focus of our business model. We expect that our research and development expenses will increase in the future in connection with the continuation of our CRB-701 and CRB-913 clinical trials across all our programs.trials.

Other income, net includes tax credits in the form of refundable research and development tax credits fromand foreignthe employee retention tax authorities,credit ("ERTC"), as well as changes in derivative liabilities and foreign currency exchange gains and losses.

Research and development expenses for the year ended December 31, 20242025 totaled approximately $32.2$70.1 million, an increase of $1.1$37.9 million over the $31.2$32.2 million recorded for the year ended December 31, 2023.2024.

General and Administrative. General and Administrative expenses for the year ended December 31, 20242025 totaled approximately $16.5$15.2 million, ana increasedecrease of $2.6$1.3 million from the $13.9$16.5 million recorded for the year ended December 31, 2023.2024. The increasedecrease in fiscal 20242025 as compared to fiscal 20232024 was primarily attributable to increasesa decrease in stock-basedlegal compensation costsexpenses of $2.0$0.7 million primarily due to awards being granted at higher current fair values as compared to earlier grants, a $0.8 million increase in professional services to support operations, and a $0.3 million increase in franchise taxes. These costs are partially offset by a decrease in personnel-relatedfacility costsexpense of $0.8$0.4 million associated with prior year reductions in headcount.million.

At December 31, 2024,2025, we had total current assets of approximately $153.0$167.0 million and current liabilities of approximately $11.8$20.7 million resulting in working capital of approximately $141.2$146.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $149.7$163.9 million at December 31, 2024,2025, $144.9$162.7 million was held within the U.S.

Net cash used in operating activities for the year ended December 31, 20242025 was approximately $41.8$64.5 million which includes a net loss of approximately $40.2$78.5 million, adjusted for non-cash expenses of approximately $4.0$4.9 million, largely related to stock-based compensation expense offset by net amortization of premiums and discounts on investmentsinvestments, and approximately $5.6$9.1 million of cash usedprovided by net working capital items, principally related to decreasesan increase in accrued expenses and operatinga lease liabilities, as well as an increasedecrease in accounts payable and prepaid expenses and other current assets due to the timing in which we pay and receive invoices from our vendors.

Cash used by investing activities for the year ended December 31, 20242025 totaled approximately $121.3$1.6 million, which was largely due to purchases of investments, partially offset by proceeds from sales and maturities of investments.

Cash provided by financing activities for the year ended December 31, 20242025 totaled approximately $166.6$77.4 million. This is mainly related to proceeds from issuance of common stock under an open market sale agreement, as well as a public offering as noted below.

On May 31, 2023, we entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the “Open Market Sale Agreement”) with Jefferies LLC ("Jefferies"), as sales agent. Under the Open Market Sale Agreement, we may issue and sell, from time to time through Jefferies, shares of its common stock having an aggregate offering price of up to $150.0 million (the “2024 Open Market Offering”).

Under the Open Market Sale Agreement, Jefferies may sell the common stock by any method permitted by law deemed to be an “at-the-market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. weWe may sell common stock in amounts and at times to be determined by us subject to the terms and conditions of the Open Market Sale Agreement, but we have no obligation to sell any of the common stock in the 2024 Open Market Offering.

During the years ended December 31, 20242025 and 2023,2024, we sold an aggregate of 2,484,517563,504 and 14,1062,484,517 shares of common stock, respectively, under the Open Market Sale Agreement, for net proceeds of approximately $91.4$7.0 million and $0.1$91.4 million, respectively. As of December 31, 2024,2025, approximately $76.4$69.1 million was available for issuance and sale under the 2024 Open Market Offering.

Public OfferingOfferings

WeBased on current operating plans and assumptions regarding clinical timelines and other planned expenditures, we expect our cash, cash equivalents, and investments of approximately $149.1$163.3 million at December 31, 20242025 will be sufficient to meet our operating and capital requirements tothrough supportat ourleast operationstwelve throughmonths from the third quarterissuance of 2027,these basedconsolidated onfinancial current planned expenditures.statements.

Our contractual obligation as of December 31, 20242025 consist of our amended lease agreement (“February 2019 Lease Agreement”) for an aggregate total of 62,756 square feet of leased office space (“Total Premises”) through November 30, 2026. TotalAs rent expense for the year endedof December 31, 20242025, our contractual commitment under this lease was $1.7 millionmillion, which will be paid over the remaining term of the lease. See Note 8 "Commitments and we do not expect any significant changes in future periods. In addition, we entered into a sublease agreement with a third partyContingencies" to subleasethe 12,112consolidated squarefinancial feetstatements included under Part II, Item 8 of ourthis leasedAnnual space. The sublease commencedReport on OctoberForm 1,10-K 2021for andadditional wasinformation contractedabout toour end October 31, 2026. We terminated the sublease agreement on June 24, 2024.lease.

Pursuant to the terms of the license agreement (the "Jenrin License Agreement") with Jenrin Discovery, LLC (“Jenrin”), we are obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound we elect to develop based upon the achievement of specified development and regulatory milestones. In addition, we are obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, as defined in the Jenrin License Agreement, subject to specified reductions. A $0.4 million milestone payment was achieved and paid in 2025. We are obligated to pay Jenrin up to $18.0 million in additional potential milestone payments for further development of CRB-913.

Pursuant to the terms of the license agreement (the "UCSF License Agreement") with the Regents of the University of California, we are obligated to pay up to $150.8 million in remaining potential milestone payments totaling up to $153.2 million based upon the achievement of specified development and regulatory milestones, excluding indication milestones for antibodies used for diagnostic products and services that will be an additional $50.0 thousand for each new indication. In addition, we are obligated to pay royalties in the lower, single digits based on net sales of any Licensed Products, as defined in the UCSF License Agreement, and any diagnostic products and services. During the first quarter of 2025, we paid $1.6 million under the UCSF License Agreement for previously achieved milestone payments. This amount was included within accounts payable within the consolidated balance sheet as of December 31, 2024.

Corbus Pharmaceuticals Holdings, Inc. (the "Company," "Corbus," "we," "us," or "our") is a clinical-stage company focused on developing promising new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline includes CRB-701, a next-generation antibody drug conjugate ("ADC") for the treatment of Nectin-4-expressing tumors and CRB-913, an orally delivered highly peripherally restricted cannabinoid type-1 ("CB1") inverse agonist for the treatment of obesity.

CRB-913 is an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. CB1 inverse agonism is a clinically validated mechanism to induce weight loss and is a distinct mechanism of action separate from GLP-1s and the incretin class. CRB-913 has been specifically formulated to shift the drug exposure from the brain to the periphery to improve safety and tolerability, including reducing gastrointestinal ("GI") adverse events observed in the incretin class. We completed a single ascending dose (“SAD”) and multiple ascending dose (“MAD”) Phase 1a study in December 2025. The SAD portion of the trial enrolled 64 participants across 8 cohorts. The MAD portion enrolled 48 participants across 4 cohorts, including a dedicated obese cohort. The highest SAD dose tested was 600 mg/day, and the highest MAD dose tested was 150 mg/day. In the dedicated obese MAD cohort (150 mg/day), all CRB-913-treated participants (n=9), and none in the placebo group (n=3), experienced weight loss. The CRB-treated participants achieved a mean 2.9% placebo-adjusted weight loss by Day 14. Weight loss started early and deepened with time. CRB-913 was safe and well-tolerated across all cohorts and all doses studied, including demonstrating a very favorable GI profile with no reports of vomiting, constipation or nausea. Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative. We initiated a Phase 1b dose-range finding study (“CANYON-1”) in December 2025. The Phase 1b study plans to follow 240 U.S. subjectspatients randomized into 4 arms (placebo, 20 mg, 40 mg, and 60 mg) over a 12-week treatment period followed by a 4-week safety follow-up. The last patient was enrolled and completed thetheir firstlast clinical visit ("Lastin PatientAugust First2026. Visit")We remain on track to report data in CANYON-1 in AprilSeptember 2026. Completion is expected in summer 2026.

We are a clinical-stage company focused on developing promising new therapies in oncology and obesity and have not generated any revenues from the sale of products. We do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the marketing of one of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have never been profitable and at MarchJune 31,30, 2026, we had an accumulated deficit of approximately $578.4$613.4 million. Our net losses for the three months ended MarchJune 31,30, 2026 and 2025, were approximately $23.0$35.0 million and $17.0$17.7 million, respectively. Our net losses for the six months ended June 30, 2026 and 2025 were approximately $58.0 million and $34.6 million, respectively.

Comparison of Three Months Ended MarchJune 31,30, 2026 and 2025

Operating Expense.Expenses. The following table summarizes our operating expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and Development. The following table summarizes our research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and development expenses for the three months ended MarchJune 31,30, 2026 totaled approximately $19.8$31.2 million, an increase of $4.2$16.0 million from approximately $15.6$15.2 million recorded for the three months ended MarchJune 31,30, 2025.

Total program-specific costs increased by $3.4$15.7 million for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025. Costs related to CRB-701 increased by $1.3$14.6 million primarily as a result of the $10.0 million development milestone payment made to CSPC in Q2 2026, as well as higher clinical costs as additional participants are enrolled in the ongoing Phase 1/2 clinical trial,trial partiallyand offsetwe bybegin apreparing decreasefor inthe manufacturingstart costs.of TEMPO-1. CRB-913 costs increased by $3.6$4.1 million primarily due to enrollmenthigher inclinical costs as the Phase 1b portion of the clinical study,study whichhas begancompleted inenrollment Decemberand 2025.treatment progresses. Costs related to CRB-601 decreased by $1.5$3.0 million as the Phase 1 dose escalation study was completed and no additional patients were enrolled in Q1fiscal year 2026.

Personnel-related costs increased by $0.7$0.2 million for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025. The increase is primarily due to an increase in headcount.

We have a subsidiary in each of the U.K. and Australia. During the three months ended MarchJune 31,30, 2026 and 2025, approximately 27%20% and 38%31% of research and development expenses, respectively, were recorded in these entities.

General and Administrative. General and administrative expenseexpenses for the three months ended MarchJune 31,30, 2026 totaled approximately $4.5$5.0 million, an increase of $0.4$1.0 million from approximately $4.1$4.0 million recorded for the three months ended MarchJune 31,30, 2025. The increase in fiscal quarter 2026 as compared to fiscal quarter 2025 was attributable to an increase in compensation costs of $0.2$0.4 million primarily due to an increase in headcountheadcount, an increase of $0.3 million in legal costs and a $0.2 million increase in recruiting expense primarily due to search costs for open positions in the current year.

Other Income, Net. The following table summarizes our total other income, net for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Total other income, net for the three months ended MarchJune 31,30, 2026 totaled approximately $1.3$1.2 million, a decrease of $1.5$0.3 million from approximately $2.8$1.5 million recorded for the three months ended MarchJune 31,30, 2025. The decrease in 2026 as compared to 2025 was primarily attributable to foreign exchange and a $1.1decrease millionin employeeinterest retentionand creditinvestment recorded during 2025. No employee retention credit was recorded during 2026.income.

Since inception, we have experienced negative cash flows from operations. We have financed our operations primarily through sales of equity-related securities. At MarchJune 31,30, 2026, our accumulated deficit since inception was approximately $578.4$613.4 million.

At MarchJune 31,30, 2026, we had total current assets of approximately $143.6$122.8 million and current liabilities of approximately $18.1$21.5 million, resulting in working capital of approximately $125.4$101.3 million. Of our total cash, cash equivalents, investments, and restricted cash of $138.6$118.3 million at MarchJune 31,30, 2026, approximately $137.0$115.7 million was held within the U.S. On May 31, 2023, we entered into Amendment No. 1 to the Open Market Sale Agreement originally dated August 6, 2020 (as amended, the "Open Market Sale Agreement") with Jefferies LLC ("Jefferies"), as sales agent. From April 1, 2026 through the date of filing, we sold 872,917 shares of our common stock pursuant to the Open Market Sale Agreement for which we received net proceeds of approximately $8.9 million. We also filed a new shelf registration statement which was declared effective on March 20, 2026 for which we are authorized to offer and sell securities up to $300.0 million.

The following table summarizes our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026 totaled approximately $22.5$40.7 million, which was principally related to proceeds from sales and maturities of marketable securities.

Based on current operating plans and assumptions regarding clinical timelines and other planned expenditures, we expect our cash, cash equivalents, and investments of approximately $138.2$117.9 million at MarchJune 31,30, 2026 will be sufficient to meet our operating and capital requirements through at least twelve months from the issuance of this Quarterly Report on Form 10-Q.

In April 2026, we paid CSPC $10.0 million pursuant to the achievement of a development milestone. Pursuant to the terms of the license agreement with CSPC (the “CSPC License Agreement”),Agreement, we are obligated to pay remaining potential milestone payments to CSPC totaling up to $130.0$120.0 million based upon the achievement of specified development and regulatory milestones and $555.0 million in potential commercial milestone payments. In April 2026, we paid CSPC $10.0 million pursuant to the achievement of a development milestone. In addition, we are obligated to pay CSPC royalties in the low, double digits based on net sales of any Licensed Products, as defined in the CSPC License Agreement.

The CSPC License Agreement will remain in effect on a Licensed Product and on a country-by-country basis, until the expiration of the Royalty Term of the Licensed Product in the country. The Royalty Term is the period beginning from the First Commercial Sale of the Licensed Product in the country until the later of the expiration of the last-to-expire Valid Claim in any Licensor Patent in the country that Covers the Licensed product, 10 years after the date of the First Commercial Sale in the country, or expiration of the Regulatory Exclusivity for the Licensed Product in the country. The CSPC License Agreement may be terminated earlier in specified situations, including termination for material breach, termination by Corbusus with advance notice, and termination upon a party's bankruptcy.