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

We are a clinical stage oncology company with a limited operating history. Since our inception, we have incurred significant operating losses. We reported net losses of $77.3$79.6 million and $73.8$77.3 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $363.6$443.2 million. To date, we have not generated any revenues from product sales and have financed our operations primarily through equity offerings. As such, we expect that it will be several years, if ever, before we have a product candidate ready for regulatory licensure and commercialization. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. To become and remain profitable, we must succeed in developing, obtaining marketing licensure for and commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including, without limitation, procuring clinical- and commercial-scale manufacturing, successfully completing preclinical studies and clinical trials of our product candidate, establishing arrangements with third parties for the conduct of our clinical trials, obtaining marketing licensure for our product candidate, manufacturing, marketing and selling any products for which we may obtain marketing licensure, discovering or obtaining rights to additional product candidates, identifying collaborators to develop product candidates we identify or additional uses of our existing product candidatescandidate and successfully completing development of our product candidatescandidate for our collaboration partners.

continue to develop, conduct clinical trials and seek regulatory approvals for micvotabart pelidotinMICVO;

We have substantial doubt about our ability to continue as a going concern and we will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may not be able to continue as a going concern or we may be forced to delay, reduce or eliminate one or more of our research and product development programs or future commercialization efforts.

The development of biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing and planned activities, particularly as we continue our clinical trials for micvotabartMICVO. pelidotin.As of December 31, 2025, we had approximately $68.3 million in cash, cash equivalents, restricted cash and marketable debt securities. We currently expectbelieve that our existing cash, cash equivalents and short-termmarketable investmentsdebt of $126.9 millionsecurities as of December 31, 2024,2025, will be sufficient to fund our projected operating expenses and capital requirementsoperations into the secondfourth halfquarter of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect. Even if our product candidate is approved for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the FDA, the EMA or other comparable regulatory authorities to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

If we are unable to obtain funding on a timely basis or on acceptable terms, we may not be able to continue as a going concern, we may have to delay, reduce or terminate our clinical trials, limit strategic opportunities or undergo reductions in our workforce or other corporate restructuring activities. We also could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to some of our technologies or our product candidatescandidate that we would otherwise pursue on our own. We will be required to seek additional funding in the future and our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. Additional funds may not be available to us on acceptable terms or at all. For example, market volatility resulting from global economic developments, political unrest, high inflation and other factors could adversely impact our ability to access capital as and when needed. If we raise additional funds by issuing equity securities, our stockholders will suffer dilution and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders.

In addition, investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our business, financial condition or results of operations. In addition, changes in global macroeconomic conditions and government trade policies could further increase our operating costs and accelerate our need for additional capital. New or increased tariffs, trade restrictions, retaliatory measures, or other limitations on the movement of goods and services, whether imposed by the United States or other jurisdictions, could increase the cost of materials, equipment and services used in our research, development and manufacturing activities. Such measures could also disrupt global supply chains, increase transportation and logistics costs, and create delays in the delivery of clinical supplies. Any of these developments could materially increase our cash burn, delay development timelines, and adversely affect our ability to obtain additional financing on acceptable terms, or at all.

We are heavily dependent on the success of our product candidate, micvotabart pelidotin,MICVO, which is in the early stages of clinical development. If micvotabart pelidotinMICVO is not successful in clinical trials or does not receive regulatory approval or licensure or is not successfully commercialized, our business will be materially and adversely affected.

To date, we have invested a significant portion of our efforts and financial resources in the development of micvotabart pelidotin.MICVO. Our future success is substantially dependent on our ability to successfully initiate and complete clinical development for, obtain regulatory licensure for, and successfully commercialize micvotabart pelidotin,MICVO, which may never occur. We currently have no products that are approved or licensed for commercial sale and may never be able to develop a marketable product. We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to the clinical development, management of clinical and manufacturing activities, regulatory licensure, establishing commercial scale manufacturing, and significant sales, marketing, and distribution efforts related to micvotabart pelidotinMICVO before we can generate any revenues from any commercial sales. We cannot be certain that we will be able to successfully complete any of these activities or that, even if micvotabart pelidotinMICVO receives regulatory licensure, such product will be able to successfully compete against therapies and technologies offered by other companies.

The research, testing, manufacturing, labeling, licensure, sale, packaging, marketing, and distribution of biological products are subject to extensive regulation by the FDA and comparable regulatory authorities in other countries. We are not permitted to market micvotabart pelidotinMICVO in the U.S. until we receive licensure of a BLA or NDA from the FDA for such product candidate, as appropriate. Further, we are not permitted to market micvotabart pelidotinMICVO in any foreign countries until we receive the requisite licensure or approvals from such countries. We have not submitted a BLA or NDA to the FDA or comparable applications to any other comparable regulatory authorities for micvotabart pelidotin.MICVO. We will not be in a position to do so for several years, if ever. If we are unable to obtain the necessary regulatory licensure or approvals for micvotabart pelidotin,MICVO, our financial position will be materially adversely affected, and we may not be able to generate sufficient revenues to continue our business.

We have no experience as a company completing a clinical trial or submitting a BLA or NDA and may be unable to successfully do so for micvotabart pelidotin.MICVO.

The conduct of a clinical trial is a long, expensive, complicated and highly regulated process. Although certain of our employees have conducted successful clinical trials and made regulatory submissions in the past across many therapeutic areas while employed at other companies, we, as a company, have not completed any clinical trials, or submitted a BLA or NDA, and as a result may require more time and incur greater costs than we anticipate. Failure to commence or complete, or delays in, our clinical trials or planned regulatory submissions would prevent us from, or delay us in, obtaining regulatory approval of and commercializing micvotabart pelidotin,MICVO, which would adversely impact our financial performance. Large-scale clinical trials would require significant additional financial and management resources and heavier reliance on third party clinical research organizations (CROs) and consultants. Relying on third party CROs and consultants may cause us to encounter delays or other operational issues that are outside of our control. Although our third parties are required to comply with good laboratory practice (GLP) and good clinical practice (GCP) for any studies or trials we plan to submit to a regulatory authority, and have historically complied, relying on third parties in the conduct of our preclinical studies or clinical trials exposes us to a risk that they may not adequately comply with GLP or GCP in the futurefuture. We may be unable to identify and contract with sufficient investigators, CROs and consultants on terms that are acceptable to us on a timely basis or at all.

Before obtaining regulatory licensure for the commercial sale of our product candidate we must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that our product candidate is safe, pure, and potent, as required under a BLA. Preclinical and clinical testing is expensive and can take many years to complete and the outcome of these activities is inherently uncertain. Failure can occur at any time during the preclinical studies and clinical trial processes and, because our product candidate is in an early stage of development, there is a high risk of failure. In addition, any failures or adverse outcomes in preclinical or clinical testing seen by other developers of a similar product candidatescandidate could materially impact the success of our program. We may never succeed in developing marketable products.

It is also possible that the results of preclinical studies and early clinical trials of our product candidate may not be predictive of the results of later-stage clinical trials. Although our product candidate may demonstrate promising results in preclinical studies and early clinical trials, it may not prove to be effective in subsequent clinical trials. For example, testing on animals occurs under different conditions than testing in humans and, therefore, the results of animal studies may not accurately predict human experience. There is typically an extremely high rate of attrition from the failure of a product candidatescandidate proceeding through preclinical studies and clinical trials. ProductA candidatesproduct candidate in later stages of clinical trials may fail to show the desired safety, purity, and potency profile despite having progressed successfully through preclinical studies and/or initial clinical trials. Likewise, early, smaller-scale clinical trials may not be predictive of eventual safety, purity and potency in large-scale pivotal clinical trials. Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of potency, insufficient durability of potency or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence preclinical studies and clinical trials are never approved or licensed for commercialization. In addition, preclinical studies or clinical trials we conduct may contradict, undermine or otherwise not replicate or advance the results of the research programs and preclinical studies that were completed prior to our in-licensing or acquisition of our product candidates,candidate, which may materially and adversely affect our business, results of operations and prospects.

From time to time, we may publish interim top-line or preliminary data from our clinical trials. For example, in NovemberDecember 2024,2025, we announced preliminary data from our dose expansion phase of Phase 1 clinical trial of micvotabart pelidotin.MICVO. Preliminary data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. Preliminary or top-line data may include, for example, data regarding a small percentage of the patients enrolled in a clinical trial, and such preliminary data should not be viewed as an indication, belief or guarantee that other patients enrolled in such clinical trial will achieve similar results or that the preliminary results from such patients will be maintained. As a result, interim and preliminary data should be viewed with caution until the final data is available. Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

We may expend our resources to pursue a particular product candidatescandidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success.

As a result of our limited financial and managerial resources, we must make strategic decisions as to which targets and product candidatescandidate to pursue and may forego or delay pursuit of opportunities with other targets or product candidates or for other indications that 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. Failure to properly assess a potential product candidatescandidate could result in our focus on a product candidatescandidate with low market potential, which would harm our business, financial condition, results of operations and prospects. Our spending on current and future research, our product candidatescandidate and discovery programs for specific targets or indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

The market may not be receptive to micvotabart pelidotinMICVO because it is based on our novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of this product candidate.

Even if regulatory licensure is obtained for our product candidate, we may not gain sufficient market acceptance among physicians, patients, healthcare payors and others in the medical community. Micvotabart pelidotinMICVO is based on the FACT Platform. Our future success depends on the successful development of this novel therapeutic approach. Additionally, the regulatory licensure process for a novel product candidate such as ours can be more expensive and take longer than for other, better-known or extensively-studied product candidates. No regulatory authority has granted licensure for any therapeutic using the FACT Platform. As a result of these factors, it is more difficult for us to predict the time and cost of product candidate development. Any development problems we experience in the future related to our program may cause significant delays or unanticipated costs or may prevent the development of a commercially viable product. Advancing our products creates significant challenges for us, including educating medical personnel regarding the potential potency and safety benefits, as well as the challenges, of incorporating our product candidate, if approved, into treatment regimens and establishing the sales and marketing capabilities to gain market acceptance, if approved.

We are early in our development efforts. Our lead product candidate, micvotabart pelidotin,MICVO, is in the early stages of clinical development. The results of preclinical studies and early stage clinical trials may not be predictive of future results in later studies or trials. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage clinical trials.

The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early stage clinical trials that are continuing may not be predictive of the results of the later stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed on in later stage clinical trials. In particular, the small number of patients in our Phase 1 clinical trial may make the result of this trial less predictive of the outcome of later clinical trials. Moreover, preclinical and clinical data often are susceptible to varying interpretations and analyses, and many companies that have believed their product candidatescandidate performed satisfactorily in preclinical studies and clinical trials nonetheless have failed to obtain marketing licensure of their products. Our clinical trials may not ultimately be successful or support further clinical development of micvotabart pelidotin.MICVO. There is a high failure rate for a product candidatescandidate proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving encouraging results in earlier studies. Any such setbacks in our clinical development could materially harm our business, results of operations, financial condition and prospects.

The development and commercialization of therapeutic biological products is highly competitive. We compete with a variety of multinational biopharmaceutical companies and specialized biotechnology companies, as well as technology being developed at universities and other research institutions. Our competitors have developed, are developing or will develop product candidates and processes competitive with our product candidate. Competitive therapeutic treatments include those that have already been approved or licensed and accepted by the medical community and any new treatments that enter the market. We believe that a significant number of products are currently under development, and may become commercially available in the future, for the treatment of conditions for which we may try to develop a product candidates.candidate. The biotechnology and pharmaceutical industries, including the oncology subsector, are characterized by rapidly evolving technologies, intense competition and strong defense of intellectual property and proprietary technologies. Any product candidate that we successfully commercialize may be competitive with currently marketed therapies and any new therapies commercialized in the future.

If our product candidate is licensed, it will compete with a range of therapeutic treatments that are either in development or currently marketed. Many companies are active across various stages of development in the oncology subsector and are marketing and developing products that employ similar ADC and immunotherapy approaches. As of February 2025,2026, there were approximately 650900+ ADCs in clinical or preclinical development worldwide, of which the vast majority are being developed for the treatment of various cancer indications. Additionally, there are several large and small companies working on various immunotherapy approaches for treatment of cancer. Multiple companies are also involved in the development of ADC therapeutics and immunotherapies, including, but not limited to, AbbVie Inc., Abcure, Inc., ADC Therapeutics SA, Alligator Bioscience AB, Astellas Pharma, Inc., AstraZeneca plc, Celldex Therapeutics, Inc., Daiichi Sankyo Company, Ltd., Eucure Biopharma, a subsidiary of Biocytogen, Genentech, Inc., Gilead Sciences, Inc, GlaxoSmithKline, plc, Johnson & Johnson, Lyvgen Biopharma, Nextcure, Inc., Pfizer, Philogen S.p.A., Merck Sharpe & Dohme (MSD), Corbus Pharmaceuticals, and Rakuten Medical, Inc.

WeThere face competition on specific targets, including the target of our micvotabart pelidotin candidate, EDB+FN, from Philogen S.p.A. as well asare other emerging agents in key indications of interest including R/M HNSCC. Merus’sGenmab’s EGFR and LGR5 targeting biclonic,biclonal, petosemtamab, and Bicara’s EGFR/TGF-beta targeting bifunctional, ficerafusp alfa (BCA101), and Johnson and Johnson’s EGFR and cMET bispecific antibody, amivantamab, are notable competitors that are targeting patient populations of interest to micvotabart pelidotinMICVO and pose a potentially significant threat to our clinical development strategy. Additionally, Corbus Pharmaceutical’s nectin-4 targeting ADC, CRB-701 has shown preliminary efficacy data and is a direct competitor given similarity in payload (MMAE) to MICVO, and comparable patient populations and clinical development timelines in R/M HNSCC.

Other competitors may also include agents targeting specific segments such as HPV+ HNSCC, namely Hookipa’sNeoTrail Therapeutics (formerly Hookipa)’s and PDS Biotech’s vaccines and agents such as Nanobiotix’s radioenhancer that may be used earlier in the treatment sequence. Furthermore,With therethe are also some ADCs such as Sacituzumab govitecan, Gilead’s TROP-2 ADC, Pfizer’s Nectin-4 targeting ADC, enfortamab vedotin, and AZ’s AZD9592, a dual targeting ADC against EGFR and cMET that are in clinical development in HNSCC and have shown preliminary clinical efficacy in early stage trials. Additionally, there is a wide arrayapproval of activitypembrolizumab in the developmentperi-operative setting based on Keynote-689, use of immunotherapiesIO forin oncologythe whichneoadjuvant and adjuvant settings may beshift competitivehow withHPV ourpatients preclinicalare discoverytreated programs.in earlier lines of therapy. The implementation of using IO in the earlier disease settings could impact patient segmentation and treatment choices in the R/M setting.

The time required to obtain approval or licensure by the FDA and other comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval and licensure policies, regulations or the type and amount of clinical data necessary to gain approval or licensure may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained marketing approval or licensure for any product candidate, and it is possible that our existing product candidate, or any product candidatescandidate we may seek to develop in the future, will never obtain marketing approval or licensure.

The FDA and foreign regulatory authorities will continue to monitor closely the safety profile of any product even after approval. If the FDA or foreign regulatory authorities become aware of new safety information after approval of a product candidate, they may require labeling changes or establishment of a Risk Evaluation and Mitigation Strategies (REMS), if not already established in pre-approval, or similar strategy, impose significant restrictions on its indicated uses or marketing, or impose ongoing requirements for potentially costly postapprovalpost approval studies or post-market surveillance.

We may seek additional Breakthrough Therapy Designation and/or Fast Track Designation for our product candidate. For example, in February 2025, the FDA granted Fast Track Designation for use of micvotabart pelidotinMICVO in the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody. The FDA may withdraw the Fast Track Designation if the clinical development program no longer meets the criteria for Fast Track Designation. There is no assurance that the FDA will grant these designations to any of our current or future product candidates. A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs or biological products, to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug or biological products may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as Breakthrough Therapies, increased interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as Breakthrough Therapies by the FDA may also be eligible for other expedited approval programs, including Accelerated Approval and Priority Review, if they meet regulatory requirements for those other programs.

We may seek Orphan Drug Designation for one or more of our current or future product candidates. For example, in May 2023, the FDA granted Orphan Drug Designation for micvotabart pelidotinMICVO in pancreatic cancer. Also, the FDA granted Orphan Drug Designation for PYX-107 in the treatment of soft tissue carcinoma, esophageal and GEJ cancers. Regulatory authorities in some jurisdictions, including the U.S. and Europe, may designate drugs or biological products for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the U.S., or a patient population greater than 200,000 in the U.S. when there is no reasonable expectation that the cost of developing and making available the drug in the U.S. will be recovered from sales in the U.S. for that drug or biological product. In the U.S., Orphan Drug Designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. After the FDA grants Orphan Drug Designation, the identity of the drug or biological product and its potential orphan use are disclosed publicly by the FDA. Orphan Drug Designation does not convey any advantage in, or shorten the duration of, the regulatory review and licensure process.

The U.S. CongressIt is also consideringpossible updatesthat tocurrent or future litigation or action by Congress could change the orphan drug provisionsscope of theavailable Federalorphan Food, Drug, and Cosmetic Act (FDCA) in response to a 2021 11th Circuit decision.exclusivity. Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivity and would materially adversely affect our business, financial condition, results of operations, cash flows and prospects.

Accelerated Approval by the FDA, even if granted, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidate will receive marketing licensure. If not granted, we may be required to conduct additional nonclinicalnon-clinical and clinical studies and trials beyond those that we currently contemplate. Even if we receive Accelerated Approval, if our confirmatory post-marketing trial does not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw Accelerated Approval.

We plan to seek Accelerated Approval of micvotabart pelidotinMICVO and may seek approval of future product candidates through the FDA’s Accelerated Approval Program. For any licensure to market a biological product, we must provide the FDA and comparable foreign regulatory authorities with clinical data that adequately demonstrate the safety, purity, and potency of the product for the indication applied for in the NDA or BLA or other respective regulatory filings. The Accelerated Approval Program is one of several approaches used by the FDA to make prescription drugs or biological products more rapidly available for the treatment of serious or life-threatening diseases. Section 506(c) of the FDCA provides that the FDA may grant Accelerated Approval to “a product for a serious or life-threatening condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.” Licensure through the Accelerated Approval Program is subject, however, to the requirement that a sponsor perform adequate and well controlled post-marketing clinical trials to verify and describe the drug’s clinical benefit, where there is uncertainty as to the relationship of the surrogate endpoint to the clinical benefit, or of the observed clinical endpoint to ultimate outcome. Typically, clinical benefit is verified when post-marketing clinical trials show that the biological products provide a clinically meaningful positive therapeutic effect, that is, an effect on how a patient feels, functions, or survives. If required, these confirmatory trials must be underway prior to Accelerated Approval, pursuant to the Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted in 2022 and under FDA’s draft guidance on “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” made available in January 2025. In addition, Section 506(c) of the FDCA provides FDA authority to impose specific conditions on Accelerated Approval, including requiring post-approval study(ies) to verify and describe clinical benefit, and requiring submission of promotional materials during the pre-approval review period and, following approval and for such period thereafter as FDA determines appropriate, at least 30 days prior to dissemination. The statute also requires FDA, by no later than the date of Accelerated Approval, to specify conditions for required post-approval studies, which may include enrolment targets, protocol, and milestones (including a target completion date), and FDA may require such studies to be underway prior to approval or within a specified time period after approval. If such confirmatory post-marketing trials fail to confirm the product’s clinical profile or risks and benefits, or if we fail to conduct any required confirmatory trial with due diligence, or other evidence shows the product is not safe and effective under the conditions of use, the FDA may withdraw Accelerated Approval of the product.

The FDA has broad discretion with regard to licensure through the Accelerated Approval Program and even if we believe that the Accelerated Approval Program is appropriate for one of our products, we cannot assure you that the FDA will ultimately agree. The FDA may also change its policies with respect to over Accelerated Approval over time. For example, in March 2023, the FDA announced the availability of draft guidance on “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics,” in which the Agency outlined, and invited public comment on, its “preferred approach” of randomized controlled trials, including those that provide for longer term follow-up that could fulfill a post-marketing requirement to verify clinical benefit. The draft guidance, while not finalized, included statements where the FDA acknowledged that historically, single-arm trial designs and response endpoints have most commonly been used in oncology, but noted that such trials have limitations. Furthermore, even if we do obtain licensure through the Accelerated Approval Program, we may not experience a faster development process, review, or licensure compared to conventional FDA procedures.

Moreover, Congress is considering potential changes to the Accelerated Approval Program that could impact our ability to obtain Accelerated Approval, or increase the burdens associated with post-marketing requirements in the event we do obtain Accelerated Approval. In particular, the FDA must specify certain conditions for required postapprovalpost approval studies for products that receive Accelerated Approval, which may include enrollment targets and milestones, including the target date for study completion, by the time the drug is approved. The FDA may also require postapprovalpost approval studies to be underway at the time of Accelerated Approval or within a specified time period following Accelerated Approval for such drugs, and must explain any instances where it does not require such studies. FDA’s January 2025 draft guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway, while not finalized, suggests that FDA generally intends to consider a confirmatory trial to be "underway" prior to Accelerated Approval if (1) the trial has a target completion date that is consistent with diligent and timely conduct of the trial, considering the nature of the trial’s design and objectives, (2) the sponsor’s progress and plans for postapprovalpost approval conduct of the trial provide sufficient assurance to expect timely completion of the trial, and (3) enrollment of the confirmatory trial has been initiated.

We may seek to identify patient subsets within a disease category that may derive selective and meaningful benefit from the product candidate we are developing. Through collaborations or license agreements, companion diagnostics may help us to more accurately identify patients within a particular subset, both during our clinical trials and in connection with the commercialization of our product candidate, if approved. In connection with the clinical development of our product candidate for certain indications, we may work with collaborators to develop or obtain access to companion diagnostic tests to identify appropriate patients for our product candidate. We may rely on third parties for the development, testing and manufacturing of these companion diagnostics, the application for and receipt of any required regulatory clearances or approvals, and the commercial supply of these companion diagnostics. Companion diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as a medical device and may require separate regulatory authorization prior to commercialization. The FDA and foreign regulatory authorities regulate companion diagnostics as medical devices that will likely be subject to clinical trials in conjunction with the clinical trials for a product candidates,candidate, and which will require separate regulatory clearance or approval prior to commercialization. This process could include additional meetings with health authorities, such as a pre-submission meeting and the requirement to submit an investigational device exemption (IDE). In the case of a companion diagnostic that is designated as “significant risk device,” approval of an IDE by the FDA and an IRB is required before such diagnostic is used in conjunction with the clinical trials for a corresponding product candidate. We or our third party collaborators may fail to obtain the required regulatory clearances or approvals, which could prevent or delay approval of our product candidates.candidate. In addition, the commercial success of our product candidate that requires a companion diagnostic will be tied to and dependent upon the receipt of required regulatory clearances or approvals and the continued ability of such third parties to make the companion diagnostic commercially available to us on reasonable terms in the relevant geographies.

Healthcare providers, physicians and third party payors in the U.S. and elsewhere will play a primary role in the recommendation and prescription of any product candidatescandidate for which we obtain marketing licensure. Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers, drug wholesalers/distributors, pharmacy benefit managers, and third party payors subject us to various federal and state fraud and abuse laws and other healthcare laws that may constrain the business or financial arrangements and relationships through which we research, develop, sell, market and distribute our product candidate, if we obtain marketing licensure. In particular, the research of our product candidate, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business or financial arrangements.

Even if we commercialize our product candidate, it or any other product candidatescandidate that we develop, may become subject to unfavorable pricing regulations or third party coverage or reimbursement practices, which could harm our business.

In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles,cycles including,and forlegislative developments. For example, the current presidential administration’s commitment to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS, FDA and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations. The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of artificial intelligence to review product applications. And, the recent federal government shutdown may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions. These developments may lead to greater uncertainty regarding FDA policies, slower response times and longer review periods, potentially affecting our ability to progress development of our product candidate or obtain regulatory approval for our product candidate.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinicalclinical, and scientific personnel. We are highly dependent upon members of our senior management, including LaraThomas Sullivan,Civik, M.D.,currently ourserving Presidentas andInterim Chief Executive Officer,Officer of the Company, Jitendra Wadhane, who serves as Principal Financial and Pamela Connealy, our Chief Financial Officer and Chief OperatingAccounting Officer, as well as our senior scientists, senior medical personnel and other members of our senior management team. The loss of one or more of our executive officers, senior scientists, senior medical personnel and other members of our senior management team could delay or prevent the successful development of our product pipeline, the initiation and completion of our clinical trials or the commercialization of our product candidate or any future product candidates.candidate.

Pyxis Oncology is a clinical stageclinical-stage oncology company executing onadvancing a development strategy designedfocused toon addressaddressing unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC) tumors..

The following table summarizes our clinical pipeline reflecting this prioritized focus:

In early January 2025, we initiated theThe dose expansion phase (Part 2) of theour PYX-201-101 monotherapy study is ongoing with athe prioritizedobjective focusof tofurther confirmevaluating the preliminary safety, efficacy and durability signals observed with MICVO in R/M HNSCC seenat the 5.4mg/kg dose. We completed target enrollment of approximately 40 patients in Partthe 1.Phase We1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026 and are actively recruitingtreating patients forin two monotherapy R/M HNSCC expansioncohorts cohorts.at the 5.4 mg/kg IV Q3W dose. The Part 2 dose expansion phase includes the following two R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:

micvotabart pelidotinMICVO monotherapy for second line (2L) and third line (3L) R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose, a pharmacologically active dose identifiedand duringanticipate Partreporting 1updated ofclinical data from this trial where we have seen clinically meaningful anti-tumor activity with manageable safety. We anticipate having preliminary datacohort in the second half of 2025mid-2026; and micvotabart pelidotinMICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort also at the 5.4 mg/kg IV Q3W dose and anticipate havingreporting preliminaryupdated clinical data from this cohort in the first half of 2026.mid-2026.

Since our inception, we have focused substantially all of our resources on conducting research and development activities, undertaking preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio and identifying potential product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have incurred significant operating losses since our inception. We reported net losses of $77.3$79.6 million and $73.8$77.3 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $363.6$443.2 million, net equity of $120.8$53.4 million, and cash, cash equivalents and short-termmarketable investmentsdebt securities of $126.9$66.9 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding maywill be necessary to fund future clinical and preclinical activities.

To date, we have not generated any revenues from product sales and do not expect to generate any revenues from product sales in the foreseeable future. We record revenues from research and development agreements, including amounts related to upfront receipt for license fees, royalties, sale of royalty rights, milestones and other contingent receipts and fees for research and development services.

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation and severance for our personnel in executive, legal, finance and accounting, human resources and other administrative functions. General and administrative expenses also include professional fees for auditing, tax and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.

Other income, net primarily consists of interest earned on our invested cash and cash equivalent balances, accretion of discounts associated with our marketable debt securities and sublease rental income under our sublease.

Revenues forFor the year ended December 31, 2024, wererevenues $16.1consisted million,of comparedamounts to $0recognized for the year ended December 31, 2023. In March 2024, we entered into the Settlement Agreement with Novartis,Novartis. pursuantPursuant to whichthe Settlement Agreement, we transferred our rights to future royalties on the net sales of Beovu® to Novartis in exchange for a one-time amountpayment of $8.0 million. In addition, Novartis also agreed to forgowaive its right to reclaimrecoup $8.1 million of royalties previously paid of $8.1 million to us and Apexigen. Both of these amounts were recognized as revenues upon execution of the Settlement Agreement during the year ended December 31, 2024.

Micvotabart pelidotinMICVO program-specific research and development costs increased by $18.3$14.1 million, primarily due toreflecting a $10.2$6.1 million increase in contract manufacturing costs due to the timing of MICVO manufacturing runs for micvotabart pelidotin,and a $4.8$7.5 million increase in  clinical trial relatedtrial-related expenses dueassociated towith the MICVO monotherapy and combination therapy trials, as a result of a higher number of patients dosed and asite $2.3 million increase in preclinical and translation work to support micvotabart pelidotin clinical development work.activations.

PYX-106 program-specific research and development costs increaseddecreased by $2.8$4.3 million, primarily duereflecting tolower aprogram-related $2.0expenses millionfollowing increasethe pause in clinical trialdevelopment relatedof expenses and $0.7 million increasePYX-106-101 in contractDecember manufacturing costs for our Phase 1 clinical trial, PYX-106-101.2024.

Since our inception, we have incurred significant operating losses. We reported net losses of $23.3$48.6 million and $21.2$39.5 million for the quartersix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $466.4$491.8 million. To date, we have not generated any revenues from product sales and have financed our operations primarily through equity offerings. As such, we expect that it will be several years, if ever, before we have a product candidate ready for regulatory licensure and commercialization. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. To become and remain profitable, we must succeed in developing, obtaining marketing licensure for and commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including, without limitation, procuring clinical- and commercial-scale manufacturing, successfully completing preclinical studies and clinical trials of our product candidate, establishing arrangements with third parties for the conduct of our clinical trials, obtaining marketing licensure for our product candidate, manufacturing, marketing and selling any products for which we may obtain marketing licensure, discovering or obtaining rights to additional product candidates, identifying collaborators to develop product candidates we identify or additional uses of our existing product candidate and successfully completing development of our product candidate for our collaboration partners.

Given our current cash position and ongoing clinical development expenses, we may seek additional financing through equity offerings, debt financings, collaborations or other strategic transactions. In addition, we recently completed the private placement financing subsequent to June 30, 2026, which includes warrants, and we may seek additional financing in the future to support continued development of MICVO and our operations. Any such financing may result in significant dilution to existing stockholders, impose restrictive covenants, or require us to relinquish rights to our technologies or product candidates. In addition, adverse market conditions or volatility in the biotechnology sector may limit our ability to raise capital on acceptable terms, or at all.

The development of biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing and planned activities, particularly as we continue our clinical trials for MICVO. As of MarchJune 31,30, 2026, we had approximately $42.5$34.5 million in cash, cash equivalents, restricted cash and marketable debt securities. On July 2, 2026, we completed the Private Placement with certain institutional accredited investors and received gross proceeds from the issuance of common stock under the Private Placement of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses. We believe that our cash, cash equivalents and marketable debt securities as of MarchJune 31,30, 2026, even after giving effect to the proceeds received from the Private Placement, will not be sufficient to fund ourthe Company's operations intoover the fourthnext quarter12 ofmonths 2026.from the date these unaudited condensed consolidated financial statements were included within this Quarterly Report on Form 10-Q. Accordingly, we will need to obtain substantial additional funding in order to continue our operations. However, we have based this estimate on assumptions that may prove to be wrong,incorrect, and our operating plan may change as a result of many factors currently unknown to us. In addition, we couldmay utilize our available capital resources sooner than we expect. Even if our product candidate is approved for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the FDA, the EMA or other comparable regulatory authorities to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. Accordingly, we will need to obtain substantial additional funding in order to continue our operations.

OurAdditionally, estimate as to how long we expect to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changingchanging circumstances, some of which may be beyond our control, including market volatility resulting from global economic developments, political unrest, high inflation and other factors, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

We intend to use our cash and cash equivalents for development and regulatory activities relating to our product candidate, and other general corporate purposes. Advancing the development of our product candidate will require a significant amount of capital. Our cash and cash equivalents will not be sufficient to fund our product candidate through regulatory licensure. Because the length of time and activities associated with successful research and development of any individual product candidate are highly uncertain, we are unable to estimate the actual funds we will require for development, marketing licensure and commercialization activities. The timing and amount of our operating expenditures will depend largely on:

The FDAFDA, EMA, or comparable foreign regulatory authorities from which we seek marketing licensure may modify or enhance clinical trial requirements which may affect enrollment and retention of patients and may increase costs and delay clinical programs.

Our product development costs also will increase if we experience delays in preclinical studies or clinical trials or in obtaining marketing licensure. We do not know whether any of our preclinical studies or clinical trials will need to be restructured or will be completed on schedule, or at all.all, even if completed, will yield the results that we anticipate or require. Significant preclinical study or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidate, or could allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidate, which may harm our business, results of operations, financial condition and prospects.

Further, cancer therapies sometimes are characterized as first line, second line, third line or third line.later. The FDA often approves or licenses new oncology therapies initially only for third line or later use, meaning for use after two or more other treatments have failed. When cancer is detected early enough, first line therapy, usually hormone therapy, surgery, radiation therapy, immunotherapy or a combination of these, is sometimes adequate to cure the cancer or prolong life without a cure. Second line and third line therapies are administered to patients when prior therapy is not effective. Our clinical trials are, and any future clinical trials will be, with patients with difficult to treat cancer. We expect that we would initially seek regulatory licensure for use of this product candidate in appropriate treatment settings. Subsequently, for those products that prove to be sufficiently beneficial, if any, we would expect to seek licensure potentially as a first line therapy, but any product candidate we develop, even if approved for second line or third line therapy, may not be approved for first line therapy and, prior to seeking and/or receiving any licensures for first line therapy, we may have to conduct additional clinical trials.

Regulatory expectations for oncology drug development continue to evolve. In recent years, regulatory authorities, including the U.S. Food and Drug Administration, have placed increased emphasis on dose optimization as part of Project Optimus and dose selection to balance efficacy and safety. These evolving expectations may require additional dose-ranging studies, expanded clinical trial designs, or generation of additional data beyond what we currently anticipate.

unfavorable FDAFDA, EMA or other comparable regulatory agency inspection and review of a clinical trial site;

We may submit additional INDs in the future. We may experience manufacturing delays or other delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND will result in the FDA allowing us to commence clinical trials or that, once begun, issues will not arise that lead to the suspension or termination of our clinical trials. Additionally, even if the applicable regulatory authorities agree with the design and implementation of the clinical trials set forth in our INDs, we cannot guarantee that those regulatory authorities will not change their requirements in the future, such as the IND initiatives under Operation Trailblazer from the U.S. Department of Health and Human Services in 2026, or that circumstances will not arise under which FDA or other regulatory authorities may place our clinical trials on partial or full clinical hold. These considerations apply to the INDs described above and also to new clinical trials we may submit as amendments to existing INDs or as part of new INDs in the future. Any failure to submit INDs on the timelines we expect or to obtain authorization to proceed with our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.

Our APXiMAB Platform has enabled the discovery of several product candidates with potential utility in multiple therapeutic areas and has resulted in several programs that have been licensed to third parties, including larger global biopharmaceutical companies and mid-sized regional or China-focused companies. Such arrangements generally allow the licensing parties to control the amount and timing of resources that they dedicate to the development or potential commercialization of any product candidates they develop from the technology we have licensed to them, subject to any territorial or field of use restrictions in the license. Apexigen typically negotiated milestone payments and royalty fees from the licensees that will require various levels of success with their product candidate development program in order for us to generate revenue from them. Our ability to generate revenue from these licensing arrangements will depend on our counterparties’ abilities to successfully develop and commercialize the product candidates they are developing. We cannot predict the success of any licensing program that we enterhave entered, or may enter, into or whether such program will lead to any meaningful milestone or royalty revenue to us.

We are aware of several companies that are developing cancer immunotherapiesimmunotherapies, ADCs and ADCs.other therapies for patients with HNSCC and other solid tumors targeted by our development programs. Many of these companies are well-capitalized and, in contrast to us, have significant clinical experience, and may include our existing or future collaborators. In addition, these companies compete with us in recruiting scientific and managerial talent and the patient pool available for participation in clinical trials which could negatively impact our ability to execute our business plan.

Our success will partially depend on our ability to develop and protect therapeutics that are moresafer, safe, pure,purer, and more potent than competing products. Our commercial opportunity and success will be reduced or eliminated if competing products that are safer, more effective, or less expensive than the therapeutics we develop are commercialized.

As of February 2026, there were approximately 900+Numerous ADCs and immunotherapies are currently in clinical orand preclinical development worldwide, of which the vast majority are being developedworldwide for the treatment of various cancer indications.indications, Additionally,including thereindications targeted by MICVO. These programs are severalbeing developed by both large and smallpharmaceutical companies workingand onemerging variousbiotechnology immunotherapycompanies, approaches for treatmentmany of cancer.which have substantially greater financial, development, regulatory, manufacturing and commercialization resources than we do. Multiple companies are also involved in the development of ADC therapeutics and immunotherapies, including, but not limited to, AbbVie Inc., Abcure, Inc., ADC Therapeutics SA, Alligator Bioscience AB, Astellas Pharma, Inc., AstraZeneca plc, Celldex Therapeutics, Inc., Daiichi Sankyo Company, Ltd., Eucure Biopharma, a subsidiary of Biocytogen, Genentech, Inc., Gilead Sciences, Inc, GlaxoSmithKline, plc, Johnson & Johnson, Lyvgen Biopharma, Nextcure, Inc., Pfizer, Philogen S.p.A., Merck Sharpe & Dohme (MSD), Corbus Pharmaceuticals, and Rakuten Medical, Inc.

There are other emerging agents in key indications of interest including R/M HNSCC. Genmab’s EGFR and LGR5 targeting biclonal, petosemtamab, Bicara’s EGFR/TGF-beta targeting bifunctional, ficerafusp alfa (BCA101), and Johnson and Johnson’s EGFR and cMET bispecific antibody, amivantamab, are notable competitors that are targeting patient populations of interest to MICVO and pose a potentially significant threat to our clinical development strategy. Additionally, Corbus Pharmaceutical’sPharmaceuticals’ nectin-4 targeting ADC, CRB-701 has shown preliminary efficacy data andCRB-701, is abeing direct competitor given similarity in payload (MMAE) to MICVO, and comparable patient populations and clinical development timelinesdeveloped in R/M HNSCC.HNSCC and may compete directly with MICVO for patients, investigators, clinical trial sites, development resources and future commercial opportunities. As competing therapies advance through clinical development and potentially move into later-stage or registrational studies, they may reduce the market opportunity for MICVO or diminish its competitive positioning.

Other competitors may also include agents targeting specific segments such as HPV+ HNSCC, namely NeoTrail Therapeutics (formerly Hookipa)’s and PDS Biotech’s vaccines and agents such as Nanobiotix’s radioenhancer that may be used earlier in the treatment sequence. With the approval of pembrolizumab in the peri-operative setting based on Keynote-689, use of IO in the neoadjuvant and adjuvant settings may shift how HPV patients are treated in earlier lines of therapy. The implementation of using IO in the earlier disease settings could impact patient segmentation and treatment choices in the R/M setting. The treatment landscape for HNSCC continues to evolve rapidly. Changes in standards of care, including increased use of immunotherapy and combination regimens in earlier lines of therapy, may alter patient treatment pathways, reduce the addressable patient population for MICVO in certain settings, increase regulatory expectations, or require us to conduct additional clinical trials to remain commercially competitive.

The time required to obtain approval or licensure by the FDA and other comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval and licensure policies, regulations or the type and amount of clinical data necessary to gain approval or licensure may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained marketing approval or licensure for any product candidate, and it is possible that our existing product candidate,candidates, or any product candidate we may seek to develop in the future, will never obtain marketing approval or licensure.

If we decide to seek additional Breakthrough Therapy Designation and/or Fast Track Designation by the FDA,Designation, even if granted for any of our product candidate, may not lead to a faster development ordevelopment, regulatory review or licensure process and it doesdo not increase the likelihood that our product candidate will receive marketing licensure.

We may seek additional Breakthrough Therapy Designation and/or Fastother Trackexpedited Designationregulatory designations for our product candidate. For example, in February 2025, the FDA granted Fast Track Designation for use of MICVO in the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody. The FDA may withdraw the Fast Track Designation if the clinical development program no longer meets the criteria for Fast Track Designation. There is no assurance that the FDA will grant these designations to any of our current or future product candidates. A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs or biological products, to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug or biological products may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as Breakthrough Therapies, increased interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as Breakthrough Therapies by the FDA may also be eligible for other expedited approval programs, including Accelerated Approval and Priority Review, if they meet regulatory requirements for those other programs.

We plan to seek Accelerated Approval of MICVO and may seek approval of future product candidates through the FDA’s Accelerated Approval Program. For any licensure to market a biological product, we must provide the FDA and comparable foreign regulatory authorities with clinical data that adequately demonstrate the safety, purity, and potency of the product for the indication applied for in the NDA or BLA or other respective regulatory filings. The Accelerated Approval Program is one of several approaches used by the FDA to make prescription drugs or biological products more rapidly available for the treatment of serious or life-threatening diseases. Section 506(c) of the FDCA provides that the FDA may grant Accelerated Approval to “a product for a serious or life-threatening condition upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.” Licensure through the Accelerated Approval Program is subject, however, to the requirement that a sponsor perform adequate and well controlled post-marketing clinical trials to verify and describe the drug’s clinical benefit, where there is uncertainty as to the relationship of the surrogate endpoint to the clinical benefit, or of the observed clinical endpoint to ultimate outcome. Typically, clinical benefit is verified when post-marketing clinical trials show that the biological products provide a clinically meaningful positive therapeutic effect, that is, an effect on how a patient feels, functions, or survives. If required, these confirmatory trials must be underway prior to Accelerated Approval, pursuant to the Food and Drug Omnibus Reform Act of 2022 (FDORA) enacted in 2022 and under FDA’s draft guidance on “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” made available in January 2025. In addition, Section 506(c) of the FDCA provides FDA authority to impose specific conditions on Accelerated Approval, including requiring post-approval study(ies) to verify and describe clinical benefit, and requiring submission of promotional materials during the pre-approval review period and, following approval and for such period thereafter as FDA determines appropriate, at least 30 days prior to dissemination. The statute also requires FDA, by no later than the date of Accelerated Approval, to specify conditions for required post-approval studies, which may include enrolmentenrollment targets, protocol, and milestones (including a target completion date), and FDA may require such studies to be underway prior to approval or within a specified time period after approval. If such confirmatory post-marketing trials fail to confirm the product’s clinical profile or risks and benefits, or if we fail to conduct any required confirmatory trial with due diligence, or other evidence shows the product is not safe and effective under the conditions of use, the FDA may withdraw Accelerated Approval of the product.

The FDA has broad discretion with regard to licensure through the Accelerated Approval Program and even if we believe that the Accelerated Approval Program is appropriate for one of our products, wethere cannotis assureno youassurance that the FDA will ultimately agree. The FDA may also change its policies with respect to over Accelerated Approval over time. For example, in March 2023, the FDA announced the availability of draft guidance on “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics,” in which the Agency outlined, and invited public comment on, its “preferred approach” of randomized controlled trials, including those that provide for longer term follow-up that could fulfill a post-marketing requirement to verify clinical benefit. The draft guidance, while not finalized, included statements where the FDA acknowledged that historically, single-arm trial designs and response endpoints have most commonly been used in oncology, but noted that such trials have limitations. Furthermore, even if we do obtain licensure through the Accelerated Approval Program, we may not experience a faster development process, review, or licensure compared to conventional FDA procedures.

Even if the FDA reviews a BLA seeking Accelerated Approval, there can be no assurance that licensure will be granted on a timely basis, or at all. The FDA may disagree that the design of, or results from, our studies supportsupporting Accelerated Approval. Additionally, the FDA could require us to conduct further studies or trials prior to granting licensure of any type, including by determining that licensure through the Accelerated Approval Program is not appropriate and that our clinical trials may not be used to support licensure through the conventional pathway. We might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays, or licensure might not be granted because our submission is deemed incomplete by the FDA. There also can be no assurance that after subsequent FDA feedback we will continue to pursue licensure through the Accelerated Approval Program. A failure to obtain licensure through the Accelerated Approval Program could result in a longer time period to obtain licensure of our products, could increase the cost of our products’ development, could delay our ability to commercialize our products and could significantly harm our financial position and competitive position in the marketplace.

In the U.S. and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect results of our future operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, the Inflation Reduction Act (IRA), which was signed into law on August 16, 2022, allows Medicare to: beginning in 2026, establish a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the Centers for Medicare and Medicaid Services (CMS); and, beginning in 2023, penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation, among other reforms. It is unclear how future regulatory actions to implement the IRA, as well as the outcome of pending litigation against the IRA, may affect our products and future profitability. The Medicare Part D Premium Stabilization Demonstration will also sunset at the end of the 2026 plan year and return the program to "traditional market conditions" in 2027. See Part I, Item 1, Government Regulation – Healthcare and Data Privacy Regulation – Healthcare Reform of the Annual Report on Form 10-K (Fiscal 2025 10-K) for additional detail on recent healthcare reform efforts that could affect our operations.

In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments. For example, thechanges currentin presidential administration’s commitment to significantly reducefederal government spending throughpriorities, cutsagency tostaffing federallevels, healthcareappropriations, programsworkforce reductions, regulatory priorities, administrative actions or other policy initiatives affecting HHS, FDA, CMS or other governmental agencies could alter how such agencies conduct reviews, inspections, guidance development, rulemaking and reductionsother inregulatory the workforces of key government agencies, such as HHS, FDA and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations.activities. The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of artificial intelligence to review product applications.applications and IND initiatives from HHS's Operation Trailblazer to keep the U.S. competitive. And, future federal government shutdowns may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions. TheseRegulatory developmentsuncertainty or changes in FDA policy priorities could also result in modified evidentiary requirements, additional requests for information, delays in regulatory interactions, or changes to development expectations that may leadincrease tothe greater uncertainty regarding FDA policies, slower response timescost and longer review periods, potentially affecting our ability to progress developmentcomplexity of ouradvancing MICVO and any future product candidate or obtain regulatory approval for our product candidate.candidates.

Although we work to comply with applicable laws, regulations and standards, our contractual obligations and other legal obligations, these requirements are evolving and may be modified, interpreted and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another or other legal obligations with which we must comply. Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators, or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could result in additional cost and liability to us, damage our reputation, and adversely affect our business and results of operations. We also rely on third-party service providers, contract research organizations, cloud-based technology providers and other vendors to process, store and transmit sensitive data on our behalf. Any actual or perceived failure by such third parties to adequately safeguard sensitive data, comply with applicable privacy and security requirements, or prevent unauthorized access, disclosure, loss or misuse of data could expose us to regulatory investigations, litigation, contractual liability, reputational harm, business interruption and increased compliance costs.

We have adopted a code of conduct applicable to all of our employees, officers, directors, including consultants, but it is not always possible to identify and deter misconduct by our employeesemployees, officers, directors, consultants and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, contractual damages, reputational harm, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations.

Despite the implementation of security measures, our information technology systems and infrastructure, and those of our current and any future CROs, manufacturers, other contractors, consultants, existing or future collaborators and other third party service providers are vulnerable to damage from various methods, including cybersecurity attacks, breaches, errors, malfeasance, or other technological failures, which can include, among other things, computer viruses, unauthorized access attempts, including third parties gaining access to systems using stolen or inferred credentials, ransomware attacks, denial-of-service attacks, phishing attempts, service disruptions, natural disasters, fire, terrorism, war and telecommunication and electrical failures. As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and are becoming increasingly difficult to detect. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period. We increasingly rely on third-party hosted and cloud-based technologies and service providers to support our operations, and any disruption, compromise or failure of such systems or providers could adversely affect our ability to conduct clinical development activities, protect sensitive information and maintain business continuity.

The legal and regulatory framework governing these technologies is rapidly evolving. If we fail to appropriately govern their use, or if regulators impose new restrictions or requirements, we could experience delays, increased costs, regulatory scrutiny, litigation exposure or reputational harm, any of which could materially adversely affect our business.business, financial condition and results of operations.

challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect contractual and intellectual property rights to the same extent as the U.S.;

Our research and development activities, and those of our third-party vendors, may involve the use, storage, transportation and disposal of biological materials, chemicals and other hazardous substances. These activities are subject to extensive environmental, health and safety laws and regulations. Accidental contamination, spills, exposures or other incidents could occur. Such activities may occur at our facilities or those of third-party contract research organizations, manufacturers and other service providers.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, government shutdowns, funding lapses and other disruptions to federal agency operations have occurred in recentthe years,past includingand may occur again in the future, resulting in furloughs of government employees, delays in agency activities and interruptions to regulatory processes. In October 2025, the U.S.FDA governmentannounced shuta downlapse severalin timesfederal funding and implemented shutdown procedures that affected certain regulatoryagency agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.operations If a prolonged government shutdown were to occur, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidatecandidates or we could lose certain rights to grant sublicenses.

We are a party to license agreements with Pfizer, Biosion, and the University of Chicago, pursuant to which we in-license patents and technology for certain of our product candidate,candidates, pursuant to which we may license patents and technology for future product candidate.candidates. Our current license agreements and our collaboration agreement impose, and any future license agreements or collaboration agreements we enter into are likely to impose, various development, commercialization, funding, milestone, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement and/or other obligations on us. If we breach any of these obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in products that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize products, we may be unable to achieve or maintain profitability.

We may form or seek additional collaborations or strategic alliances or enter into additional licensing arrangements in the future. If any of these collaborations, strategic alliances or licensing arrangements are not successful, we may not be able to capitalize on the market potential of theour product candidate.candidates.

We may in the future form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our current or future product candidate.candidates. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

We currently contract manufacturing operations to third parties, and large quantities of our product candidate is manufactured by these third parties globally, including in China. Any disruption in production or inability of our manufacturers to produce adequate quantities to meet our needs could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidate. ForeignCertain and certain Chineseforeign biotechnology companies and CDMOs, including those with operations in China, may become subject to U.S. legislation,legislative, regulatory or policy restrictions, including theproposals legislationsuch pending in Congress calledas the BIOSECURE Act.Act, that could restrict or prohibit our ability to utilize such service providers. The Act could impose trade restrictions, sanctions, and other regulatory requirements by the U.S. government, which could restrict or even prohibit our ability to work with such entities. If we are restricted or prohibited from working with our current CDMOs, we may incur added costs or reduction of the supply of material available to us, delays in the procurement or supply of such material or adverse effects on our ability to manufacture our product candidate. Additionally, changes in U.S. trade policy, sanctions, export controls, import restrictions, tariffs, or other measures targeting certain foreign jurisdictions or entities could increase our costs, delay clinical supply, limit access to manufacturing capacity or materials, or require us to transition to alternative vendors, which could require significant time, expense, and regulatory effort. Any such disruptions could accelerate our cash burn and increase our need for additional capital. Any of these matters could materially and adversely affect our business and results of operations. Any recall of the manufacturing lots or similar action regarding our product candidate used in clinical trials could delay the trials or detract from the integrity of the trial data and its potential use in future regulatory filings. In addition, supply chain disruptions and delays may also occur as a result of any new tariff policies or trade restrictions, which could also negatively impact third party manufacturing. For example, on April 2, 2025, the United States government announced a baseline 10% tariff on all foreign goods, with goods imported from specified nations, including China and those in the European Union, taxed at higher rates. Any of these matters could materially and adversely affect our business and results of operations. Recent U.S. biosecurity-related legislation and related regulatory actions could restrict or complicate the ability of life sciences companies to use certain third-party biotechnology service providers, including for manufacturing, testing, or research services, particularly where federal funding, grants, or contracts are implicated. To the extent we or our collaborators rely on affected providers (including providers with operations in China), we may need to transition to alternative vendors, which could increase costs, delay development timelines, and disrupt supply chains.

In order to conductcontinue conducting clinical trials of our product candidate and subsequently commercialize our product candidate, we will need to manufacture it in large quantities. Quality and feasibility issues may arise during scale-up activities. Our reliance on a limited number of CDMOs, the complexity of drug manufacturing and the difficulty of scaling up a manufacturing process could cause the delay of clinical trials, regulatory submissions, required licensure, or commercialization of our product candidate, cause us to incur higher costs and prevent us from commercializing our product candidate successfully. Furthermore, if our CDMOs fail to deliver the required commercial quality and quantities of materials on a timely basis and at commercially reasonable prices, and we are unable to secure one or more replacement CDMOs capable of production in a timely manner at a substantially equivalent cost, then testing and clinical trials of our product candidate may be delayed or infeasible, and regulatory licensure or commercial launch of any resulting product may be delayed or not obtained, which could significantly harm our business.

The manufacture of our product candidate requires the timely delivery of sufficient amounts of raw and intermediate materials. We work closely with our suppliers to ensure the continuity of supply but cannot guarantee these efforts will always be successful. Further, while efforts are made to diversify our sources of raw and intermediate materials, in certain instances we acquire raw and intermediate materials from a sole supplier. While we believe that alternative sources of supply exist where we rely on sole supplier relationships, there can be no assurance that we will be able to quickly establish additional or replacement sources for some materials.materials or that the replacement source will be obtainable at a substantially equivalent cost. A reduction or interruption in supply, and an inability to develop suitable alternative sources for such supply, could adversely affect our ability to manufacture our product candidate in a timely or cost-effective manner.

We will rely on third party CROs to conduct clinical trials for our biological product candidate. We currently do not plan to conduct any clinical trials independently. Agreements with these CROs might terminate for a variety of reasons, including for their failure to perform. Entry into alternative arrangements, if necessary, could significantly delay our product development activities.

It is possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. We may be subject to a third party submission of prior art to the USPTO, or other patent offices, in our pending patent applications. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing. In addition to the above, patent prosecution is a lengthy process, during which the scope of the claims initially submitted for examination by the USPTO may be significantly narrowed or may not issue at all. The claims of our issued patents or patent applications when issued may not cover our current or future product candidate, or even if such patents provide coverage, the coverage obtained may not provide any competitive advantage. The patent applications that we own, or in-license, may fail to result in issued patents with claims that cover our current or future product candidate in the U.S. or in other foreign countries, or we may be required to disclaim all or a portion of the remaining patent term to secure issuance. Even if patents do successfully issue, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of current and future product candidate.candidates. Further, if we encounter delays in regulatory licensure or approvals, the period of time during which we could market a product candidate under patent protection could be reduced.

If the patent applications we own or have in-licensed with respect to our product candidate and discovery programs fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our current or any future product candidate,candidates, it could dissuade companies from collaborating with us to develop and commercialize product candidatecandidates and future drugs and threaten our ability to commercialize future drugs. Any such outcome could have a negative effect on our business.

Moreover, patents have a limited lifespan. In the U.S. and internationally, a patent generally expires 20 years after the earliest filing date of a non-provisional patent application. Various extensions may or may not be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our current or future product candidate, we may be open to competition from generic and/or biosimilar versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidate, patents protecting such candidate might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent rights may not provide us with sufficient rights to exclude others from commercializing drugs similar or identical to ours. We may also rely on trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary and intellectual property position. Even if our patent rights are unchallenged, our issued patents and our pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent claims to circumvent our owned or licensed patent rights by developing similar or alternative technologies or products in a non-infringing manner. For example, a third party may develop a competitive product that provides benefits similar to one or more of our product candidates, but that has a different composition that falls outside the scope of our patent protection. If the protection provided by our patent rights with respect to our product candidates is not sufficiently broad to impede such competition, or if the breadth, strength or term (including any extensions or adjustments) of protection provided by our patent rights with respect to our product candidates or any future product candidates is successfully challenged, our ability to successfully commercialize our product candidate could be negatively affected, which would harm our business.

The licensing of intellectual property is of critical importance to our business and to our current and future product candidates, and we may enter into additional such agreements in the future. In particular, the rights to the intellectual property covering the MICVO composition of matter are in-licensed from Pfizer. If we fail to meet our obligations under any of our in-license agreements, including the amended and restated license agreement with Pfizer, dated October 6, 2022, as further amended, then the licensor may terminate the license agreement. If one of our material in-license agreements is terminated, we will lose the right to continue to develop and commercialize the product candidate(s) covered by such in-license agreement. While we would expect to exercise all rights and remedies available to us, including seeking to cure any breach by us, and otherwise seek to preserve our rights under our in-license agreements, we may not be able to do so in a timely manner, at an acceptable cost or at all. If Pfizer chooses not to defend or enforce, or fails to defend or enforce, the Licensed Platform Patent Rights, including certain patent families that read on certain aspects of MICVO, these patent rights may be adversely affected and our ability to continue the development and commercialization of MICVO may be adversely affected. If we fail to defend or enforce the Licensed ADC Patent Rights, which read directly on the MICVO composition of matter, these patent rights may be adversely affected and our ability to continue the development and commercialization of MICVO may be adversely affected.

Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming and isare likely to divert significant resources from our core business, including distracting our technical and management personnel from their normal responsibilities. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid, is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in such proceedings could put one or more of our owned or licensed patents at risk of being invalidated or interpreted narrowly and could put our owned or licensed patent applications at risk of not issuing. The initiation of a claim against a third party might also cause the third party to bring counter claims against us, such as claims asserting that our patent rights are invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent, withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter parte review, or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is or will be no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.

TheFuture future issuanceissuances of equity orsecurities, including securities issuable upon the exercise of outstanding warrants, and issuances of debt securities that are convertible into equityequity, willmay dilute our share capital.stockholders.

WeIn willaddition, needholders toof raiseoutstanding additionalwarrants capital(including inwarrants issued as part of the future.private Toplacement) theand extentother weconvertible raiseor additionalexercisable capitalsecurities throughmay theacquire issuanceshares of equityour orcommon convertible debt securitiesstock in the future, thereresulting willin beadditional dilution to our existing investors and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.stockholders. Future issuances of our common stock or other equity securities, or the perception that such sales may occur, could adversely affect the trading price of our common stock and impair our ability to raise capital through future offerings of shares or equity securities. We may choose to raise additional capital through the issuance of equity or convertible debt securities due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. No prediction can be made as to the effect, if any, that future sales of common stock or the availability of common stock for future sales will have on the trading price of our common stock.

As of May 13, 2026, our executive officers and directors, together with holders of five percent or more of our outstanding common stock and their respective affiliates, beneficially own approximately 30.2% of our outstanding common stock. As a result, these stockholders, if acting together, have significant influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transaction. The interests of these stockholders may not be the same asas, or may even conflict withwith, interests of our other stockholders. For example, these stockholders could delay or prevent a change of control of our company, even if such a change of control would benefit our other stockholders, which could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company or our assets and might affect the prevailing market price of our common stock. The significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise.

We have issued additional shares of common stock and common stock warrants in connection with the recent private placement financings which closed on July 2, 2026. Our common stock price could decline as a result of sales of a large number ofmany shares of common stock or the perception that these sales could occur. These sales, or the possibility that these sales may occur, might also make it more difficult for us to sell equity securities in the future at a time and price that we deem appropriate.

Preliminary data reported in December 2025 indicated that MICVO was generally well tolerated. No Grade 4 ADC payload treatment-related adverse events (TRAEs) of interest were observed, and no Grade 5 events occurred. TRAEs were reported in 89% (16/18) of patients, with Grade ≥3 TRAEs reported in 56% (10/18) of patients. TRAEs leading to treatment discontinuation occurred in 28% (5/18) of patients. We observed a higher discontinuation rate and incidence of Grade ≥3 TRAEs in high body weight patients (defined as at least 10% above adjusted ideal body weight, or AIBW). In the preliminary dataset, all patients (5/5) who experienced TRAEs leading to treatment discontinuation had high body weight. Several approved ADCs have demonstrated comparable associations among patient body weight, systematic drug exposure, and tolerability profiles. Many of these ADCs, such as Padcev, Adcetris, and Elahere, have addressed such observations through dosing modifications that resulted in an improved tolerability profile while sustaining efficacy, including through capping the maximum allowable dose or employing AIBW dosing. We areimplemented activelya evaluatingdose bothcap offor thesehigher approachesbody weight patients in December 2025 and continue to evaluate dosing strategies to optimize MICVO’s benefit-risk profile. The Fall 2026 clinical update is expected to include analyses of the impact of dose capping on safety, tolerability, efficacy and initial durability.

We believe the totality of our preliminary clinical and preclinical data supports MICVO’s broad potential to address a significant unmet need for patients with R/M HNSCC regardless of HPV status or prior therapy and continued clinical development of both MICVO monotherapy expansion and combination therapy trials.

The dose expansion phase of our Phase 1, PYX-201-101 monotherapy studystudy, is ongoing with the objective of further evaluating the preliminary safety, efficacy and durability signals observed with MICVO in R/M HNSCC at the 5.4mg/kg IV Q3W dose. In the first quarter of 2026, we completed target enrollment of approximately 40 patientspatients, acrossapproximately 20 in each of two 2L+ R/M HNSCC cohorts in the Phase 1 monotherapy dose expansion study of MICVOcohorts, and we are actively treating patients in both the cohorts. The dose expansion phase includes the following R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:

MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report updated clinical data from this cohort in mid-2026therapy; and MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report updated clinical data from this cohort in mid-2026.

The mid-year 2026 update will focus on participants treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, and will include detailed analyses of the impact of dose capping on safety, tolerability, and efficacy. Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs. In December 2025, we implemented a dose cap for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposure with dose capping and AIBW dosing are comparable, dose capping was prioritized for its operational simplicity and ease of implementation. A protocol amendment permitting AIBW dosing has since been approved, and AIBW dosing has begun in ongoing clinical studies. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.

During the fourth quarter of 2025, we obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.HNSCC, which continues to inform our development strategy for MICVO in this setting.

We areanticipate on track to reportreporting updated clinical data in the secondfourth halfquarter of 2026 from the ongoing PYX-201-102 Phase 1/2 dose escalation study evaluating MICVO in combination with KEYTRUDA®, with the update focused on patients with 1L R/M HNSCC.

Since our inception, we have focused substantially all of our resources on conducting research and development activities, undertaking preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio and identifying potential product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have incurred significant operating losses since our inception. We reported net losses of $23.3$48.6 million and $21.2$39.5 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $466.4$491.8 million, net equity of $31.3$11.4 million, and cash, cash equivalents and marketable debt securities of $41.0$33.0 million. Subsequent to June 30, 2026, we completed a private placement financing that generated gross proceeds of approximately $50.0 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses, and expect the upfront proceeds from the financing to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding will be necessary to fund future clinical and preclinical activities.

The components of our cost of revenues are expenses directly attributable to revenues. During the three and six months ended MarchJune 31,30, 2026 and 2025, the Company has not incurred any costs with respect to revenue.

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

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

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 increaseddecreased by $2.9$1.1 million, from $17.0$17.1 million for the three months ended MarchJune 31,30, 2025 to $19.9$16.1 million for the three months ended MarchJune 31,30, 2026.

MICVO program-specific research and development costs increaseddecreased by $5.5$0.1 million, primarily reflectingdue ato $4.4$3.5 million increase in clinical trial-related expenses due to an increased number of patients dosed in the MICVO monotherapy and combination therapy trials, as well as an $0.8$1.1 million increase in preclinical studies.studies, offset by a reduction of $4.7 million in manufacturing costs.

The following table summarizes our general and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

General and administrative expenses decreasedincreased by $1.5$4.5 million, from $5.9$5.4 million for the three months ended MarchJune 31,30, 2025 to $4.4$9.9 million for the three months ended MarchJune 31,30, 2026. This decreaseincrease was primarily attributable to a $1.8$4.4 million reductionincrease in personnel-related expenses, mainly due to loweran increase in severance costs of $1.2 million and higher stock-based compensation.compensation expense of $2.6 million.

Other income, net for the three months ended MarchJune 31,30, 2026 and 2025 was $1.1$0.6 million and $1.8$1.7 million, respectively. The decrease of $0.7$1.1 million was primarily due to lower interest and investment income,income partiallyand offset by higherlower sublease income.

We had cash, cash equivalents and marketable debt securities of $41.0$33.0 million as of MarchJune 31,30, 2026, including $10.0 million from the Private Placement proceeds received in advance on June 30, 2026. For the three months ended MarchJune 31,30, 2026 and 2025, we had net losses of $23.3$25.3 million and $21.2$18.4 million, respectively. For the six months ended June 30, 2026 and 2025, we had net losses of $48.6 million and $39.5 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $466.4$491.8 million and net equity of $11.4 million.

On November 26, 2025, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units with an aggregate offering price of up to $350.0 million. On December 9, 2025, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market (“ATM”) offering program for the sale of up to $150.0 million of shares of our common stock. During the three and six months ended MarchJune 31,30, 2026 and 2025, we did not sell any shares under the ATM program. As of MarchJune 31,30, 2026, we had $150.0 million of remaining capacity available under the ATM facility.

Until such time, if ever, we can generate substantial product revenues, we expect to continue to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends.

During the threesix months ended MarchJune 31,30, 2025,2026, net cash used in operating activities was $22.5$44.2 million, which consisted of our net loss of $21.2$48.6 million, partially offset by non-cash charges of $7.5 million and a net change in our operating assets and liabilities of $4.6 million, partially offset by non-cash charges of $3.2$3.1 million. The non-cash charges of $3.2$7.5 million waswere primarily due to $3.6$6.7 million of stock-based compensation, $0.6$0.8 million of depreciation and amortization expenses,expense and $0.5 million of non-cash operating lease expense, partially offset by $1.2$0.4 million related to accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease in accounts payable of $7.6 million, partially offset by $2.0an million,increase in accrued expenses and other current liabilities byof $1.3$4.0 million and reduction in prepaid expenses by $0.9 millionmillion, primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials. Further, net changes in our operating assets and liabilities also consists of a reduction in operating lease liabilities of $0.8 million and an increase in prepaid expenses and other current assets of $1.5 million.

During the threesix months ended MarchJune 31,30, 2026, net cash provided by investing activities was $16.4$37.7 million, which consisted primarily of $27.4 million of maturities and redemptions of marketable debt securities,securities of $51.7 million, partially offset by $11.0 million of purchases of marketable debt securities.securities of $14.0 million.

During the threesix months ended MarchJune 31,30, 2025, net cash provided by investing activities was $15.8$31.1 million, which consisted primarily of $67.2 million of maturities and redemptions of marketable debt securities,securities of $123.6 million, partially offset by $51.4 million of purchases of marketable debt securities.securities of $92.5 million.

During the threesix months ended MarchJune 31,30, 2026, net cash usedprovided inby financing activities was $0.03$10.0 million, which consisted primarily relatedof toproceeds received in advance of the Private Placement, partially offset by tax withholding payments associatedrelated with theto net settlement of restricted stockcommon awards.stock.

As of MarchJune 31,30, 2026, we had approximately $41.0$33.0 million in cash, cash equivalents and marketable debt securities. Additionally, on July 2, 2026, we completed the Private Placement which resulted in gross proceeds of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent commissions and offering expenses. We believe that our cash, cash equivalents and marketable debt securities as of MarchJune 31,30, 20262026, along with the proceeds from the Private Placement will be sufficient to fund our operations into the fourthsecond quarter of 2026.2027. However, we have based this estimate on assumptions that may prove to be wrong,incorrect, and our operating plan may change as a result of many factors currently unknown to us. In addition, we couldmay utilize our available capital resources sooner than we expect.

Our future cash flows are dependent on key variables such as our ability to secure additional sources of funding in the form of public or private financing of equity or debt or collaboration agreements or a combination of these. While we remain optimistic to obtain additional funding, the current available cash, cash equivalents and marketable debt securities, even after giving effect to the proceeds from the Private Placement, will not be sufficient to fund our operations over the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about our ability to continue as a going concern for one year from the date the unaudited condensed consolidated financial statements are issued.

We lease an office and laboratory space in Boston, Massachusetts with lease payments that continue through December 31, 2032, and have scheduled rent increases each year of 3%. Additionally, we sublease 17,729 square feet of office and laboratory space in the building located at 321 Harrison Avenue, Boston, Massachusetts. The remaining contractual fixed lease payments, net of sublease payments and tenant improvement allowance, over the term of the lease aggregate to $24.7$24.1 million. The operating lease obligation is discussed in Note 10.10, Leases to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.