What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-28 · 180 added, 147 removed, 664 unchanged (33% of the section changed)

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We have also developed antibodies for immuno-oncology and for bispecific, T cell engagement.

On March 2, 2026, we announced that our Board of Directors initiated a formal process to explore and evaluate strategic options to maximize shareholder value, including the sale of preclinical and clinical assets, licensing transactions, strategic partnerships or other corporate transactions.

There can be no assurance that this process will result in any agreements or transactions.

We do not intend to provide updates until our Board of Directors approves a specific action or otherwise determines whether disclosure is appropriate or required.

In connection with the evaluation of strategic options, we also implemented a reduction in force and other cost-containment measures intended to better align resources with our near-term priorities.

In order to continue to preserve capital during this period, we are re-evaluating the timing and scope of our clinical development programs, including the appropriate timeline and pacing of additional enrollment in the Phase 1 study of BA3182 (CAB-EpCAM x CAB-CD3) and the timeline to commence a Phase 3 study for ozuriftamab vedotin (BA3021) (CAB-ROR2-ADC) in 2L+ oropharyngeal squamous cell carcinoma (OPSCC).

While we remain focused on conducting the ongoing Phase 1 study and are committed to our clinical development programs, there can be no assurances that clinical development of our programs will not be limited or delayed pending the outcome of the strategic process.

Our mission is to develop and commercialize innovative antibody-based therapeutics for the treatment of solid tumors that are designed to bind depending on the physical and chemical properties of tumors and their microenvironment.

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Our strategy to achieve this mission is as follows:

• Advance our lead product candidates through regulatory approval and commercialization.

• Enter into collaborations to maximize the value of our platform and pipeline.

We have initiated a formal process to explore and evaluate strategic options to maximize shareholder value, including the sale of preclinical and clinical assets, licensing transactions, strategic partnerships or other corporate transactions.

As part of this process, we may enter into strategic collaborations around specific geographic regions, indications, combinations and companion diagnostics.

We may also explore collaboration arrangements to commercialize any product candidates where we believe the resources and expertise of the third party could be beneficial.

We are currently seeking partnering opportunities across our portfolio, including for our clinical-stage programs.

These collaborations could advance and accelerate our programs to maximize their market potential and expand the worldwide commercial potential of our CAB technology and assets.

• Continued prioritization of our lead product candidates.

o BA3182 (CAB-EpCAM x CAB-CD3) :

Our first bispecific candidate demonstrated in its investigational new drug (“IND”)-enabling studies a more than 100-fold improvement in the therapeutic window, as compared to a non-CAB anti-EpCAM bispecific antibody.

We are advancing a Phase 1 study in advanced adenocarcinoma.

We are conducting a Phase 1 study in advanced adenocarcinoma.

Carcinoma is the most common form of cancer and adenocarcinoma is the most common subtype.

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Almost all prostate and breast cancers are adenocarcinoma, and about 96% of colorectal cancers are adenocarcinoma (American Cancer Society 2022).

o Mecbotamab vedotin (BA3011):

Clinical data from our Phase 1 and Phase 2 part 1 trials with mecbotamab vedotin are supportive of its development in metastatic sarcomas, a set of cancers with a high unmet clinical need, and in metastatic non-small cell lung cancer (“NSCLC”) with KRAS mutations.

In addition, we have obtained Food and Drug Administration (“FDA”) clearance to initiate a potentially registration-enabling Phase 2/3 trial in NSCLC in 2 nd Line + or 3 rd Line + population.

o Ozuriftamab vedotin (BA3021):

In our Phase 1 trial, we have observed antitumor activity in NSCLC, melanoma and squamous cell carcinoma of head and neck (“SCCHN”) in patients who had failed programmed cell death protein 1 (“PD-1”) therapy, and we have an ongoing Phase 2 trial of ozuriftamab vedotin in SCCHN with fast-track designation from the FDA.

• Leverage our CAB platform to develop and enhance pre-clinical assets, including several CAB bispecific and next generation CAB ADC candidates to further address areas of high unmet needs in treating solid tumors.

Having observed multiple durable responses among patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) we are planning a Phase 3 trial for patients with OPSCC who have previously received anti-PD-(L)1 therapy and platinum-containing therapy.

We have received guidance from FDA that 1.8 mg/kg of ozuriftamab vedotin delivered every other week satisfies dose optimization requirements.

o In connection with the strategic process, we are re-evaluating the timing and scope of our clinical development programs, including the appropriate timeline and pacing of additional enrollment in the Phase 1 study of BA3182 and the timeline to commence a Phase 3 study for ozuriftamab vedotin.

• Continue to leverage our CAB platform.

We have shown in preclinical experiments, including for our Phase 1 clinical asset, BA3182, that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses.

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It is expected that this new CAB-ADC system will further reduce off-target, off-tumor toxicity and thereby expand the therapeutic window.

• Maintain and strengthen our intellectual property portfolio.

As of February 1, 2025, we had a total of 752 patents and patent applications with 479 issued patents, 13 allowed applications and 260 pending applications covering our CAB technology and product candidates.

• Maintain and leverage our intellectual property portfolio.

As of February 1, 2026, we had a total of 868 patents and patent applications with 597 issued patents, 13 allowed applications and 258 pending applications covering our technologies, including the CAB technology and product candidates.

This broad patent coverage was designed such that protection of our product candidates is not dependent on any single patent but rather, each product candidate is covered by several layers of protection.

We plan to continue to maintain, monitor, enforce and defend our intellectual property.

• Enter into collaborations to maximize the value of our platform and pipeline.

Given the potential of our technology to generate novel product candidates addressing a wide variety of solid tumors, we may opportunistically enter into strategic collaborations around specific geographic regions, indications, combinations and companion diagnostics.

We may also explore collaboration arrangements to commercialize any product candidates where we believe the resources and expertise of the third party could be beneficial.

We are currently seeking partnering opportunities across our portfolio, including for our clinical-stage programs, Ozuriftamab Vedotin and Evalstotug.

These collaborations could advance and accelerate our programs to maximize their market potential and expand the worldwide commercial potential of our CAB technology and assets.

We believe that there is significant potential to improve therapeutics for our patients with our proprietary CAB antibody technology across well-validated oncology targets in solid tumors.

The following table summarizes our current product candidate pipeline.

BA3182 (CAB-EpCAM x CAB-CD3):

Our bispecific candidate, BA3182, is currently being investigated in a Phase 1 dose escalation study in advanced adenocarcinoma.

We have leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor using dual CAB antigen-binding domains.

A bispecific antibody is a type of engineered antibody that can simultaneously bind two separate and unique antigens, unlike conventional monospecific antibodies that only bind to one type of target.

A common design feature for a bispecific antibody is to include a T cell engager component ( e.g.

, CD3 receptor), such that one antigen-binding domain recognizes a surface-expressed tumor antigen and the other antigen-binding domain binds to and activates CD3+ T cells.

With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen in a simplified manner relative to even off-the-shelf or allogeneic CAR-T therapies.

The first FDA-approved bispecific antibody was a T cell engager, blinatumomab, which contained antigen-binding domains for CD19, an antigen found on B-cell leukemias, and CD3, a T cell activating receptor.

There are many structural variants of antibodies and other antigen-binding domains being used by others to construct bispecific product candidates, some of which are being tested clinically.

However, similar to CAR-T cells and blinatumomab, many of these bispecific product candidates have increased risks of generating life-threatening cytokine release syndrome and other potential adverse events due to systemic immune activation.

We have applied our CAB antibody technology to develop bispecific CAB antibodies in which both antigen-binding domains are active only in the tumor microenvironment.

An example of this approach is our BA3182 bispecific.

Epithelial cell adhesion molecule (“EpCAM”) is a protein that is over-expressed in many cancers including carcinomas derived from colon, intestine, breast, lung and prostate.

Expression of EpCAM has been extensively associated with cell growth and proliferation of both healthy and cancer cells.

EpCAM was one of the first cancer-associated antigens discovered;

however, in the forty years since, its clinical impact as a target for therapeutic antibodies in cancer has been limited.

One of the problems with targeting EpCAM is its broad expression in the basolateral membranes of normal epithelial cells.

Conventional approaches of avoiding systemic toxicities, including deliberately selecting antibodies with low affinity for EpCAM with the intention of generating some degree of selectivity for tumors that express very high levels of EpCAM, have not been successful.

Bispecific constructs targeting EpCAM have also not lived up to expectations.

Solitomab, a third-party, non-CAB EpCAM x CD3 bispecific tested in the clinical by Amgen, led to over 95% of patients in a Phase 1 dose-escalation trial to experience at least one Grade 3 or above adverse event.

Over 20% of patients experienced dose-limiting toxicities, and at tolerated doses only one unconfirmed partial response was observed among 65 patients.

In our Phase 1 dose escalation study, we have observed several patients with tumor reduction, including one patient with cholangiocarcinoma who achieved a confirmed partial response, and we continue to explore higher doses that integrate treatment free intervals with the goal of limiting T cell exhaustion.

In connection with the strategic process, we are re-evaluating the timeline and pacing of additional enrollment in the Phase 1 study.

Ozuriftamab vedotin (BA3021):

We have advanced our clinical stage product candidate, ozuriftamab vedotin or BA3021, a CAB antibody drug conjugate directed against Receptor Tyrosine Kinase Like Orphan Receptor 2 (“ROR2”).

ROR2 is overexpressed across many different solid tumors, including breast, lung, pancreatic, renal, ovarian, and colorectal cancers, SCCHN, and melanoma;

its tumoral expression is further enhanced among those treated with PD-1 checkpoint inhibitors.

Cancer cell expression of ROR2 has been associated with enhanced cancer cell migration, EMT, increased associated risk for relapse, metastasis and unfavorable prognosis.

In breast cancer, for example, ROR2 was found to be expressed in the majority of patient samples, with those expressing ROR2 having decreased overall survival.

A similar correlation between ROR2 expression level and overall survival was observed in NSCLC and metastatic melanoma.

Genetic inactivation of ROR2 in metastatic melanoma cells was shown to prevent metastases of these tumor cells in mice.

ROR2 also has essential roles in normal cells and in early development.

Inactivation of ROR2 is lethal in mice with defects observed in the heart, nervous system and skeleton.

Less severe mutations in ROR2 in humans is associated with skeletal diseases such as Robinow syndrome and brachydactyly type B.

Ozuriftamab vedotin is a CAB anti-ROR2 ADC consisting of a CAB anti-ROR2 humanized IgG1 monoclonal antibody conjugated to MMAE using a cleavable linker.

Ozuriftamab vedotin is designed to specifically and reversibly bind to ROR2 in conditions found within the tumor microenvironment, thus conferring a selectivity binding advantage for tumors over normal cells.

Upon binding of ozuriftamab vedotin to ROR2 on the surface of tumor cells, it is internalized and the MMAE cytotoxin is released, thus killing the cancer cell.

Ozuriftamab vedotin has shown promising overall response rates in SCCHN and the FDA has granted Fast-Track designation for ozuriftamab vedotin in SCCHN.

Having observed multiple durable responses including a confirmed complete response among patients with HPV-associated OPSCC we are planning a Phase 3 trial for patients with OPSCC who have previously received anti-PD-(L)1 therapy and platinum-containing therapy (the “Phase 3 Study”).

We have received guidance from FDA that 1.8 mg/kg of ozuriftamab vedotin delivered every other week satisfies dose optimization requirements.

However, in connection with the strategic process, we are re-evaluating the timeline to commence the Phase 3 Study.

Mecbotamab vedotin (BA3011):

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We continue to see encouraging efficacy in AXL positive UPS patients, however, there is a potential need for a companion diagnostic and a likely requirement of a randomized trial in UPS.

As a result, we may prioritize the larger, recently identified mutated KRAS NSCLC opportunity which shows high correlation with AXL expression, thereby utilizing an approved readily available companion diagnostic for KRAS mutations.

Both soft tissue and bone sarcoma, as well as other indications, remain promising for potential future development.

Ozuriftabmab vedotin (BA3021):

We are developing our clinical stage product candidate, ozuriftamab vedotin or BA3021, a CAB antibody drug conjugate directed against Receptor Tyrosine Kinase Like Orphan Receptor 2 (“ROR2”).

ROR2 is overexpressed across many different solid tumors, including breast, lung, pancreatic, renal, ovarian, and colorectal cancers, SCCHN, and melanoma;

its tumoral expression is further enhanced among those treated with PD-1 checkpoint inhibitors.

Cancer cell expression of ROR2 has been associated with enhanced cancer cell migration, EMT, increased associated risk for relapse, metastasis and unfavorable prognosis.

In breast cancer, for example, ROR2 was found to be expressed in the majority of patient samples, with those expressing ROR2 having decreased overall survival.

A similar correlation between ROR2 expression level and overall survival was observed in NSCLC and metastatic melanoma.

Genetic inactivation of ROR2 in metastatic

melanoma cells was shown to prevent metastases of these tumor cells in mice.

ROR2 also has essential roles in normal cells and in early development.

Inactivation of ROR2 is lethal in mice with defects observed in the heart, nervous system and skeleton.

Less severe mutations in ROR2 in humans is associated with skeletal diseases such as Robinow syndrome and brachydactyly type B.

Ozuriftamab vedotin is a CAB anti-ROR2 ADC consisting of a CAB anti-ROR2 humanized IgG1 monoclonal antibody conjugated to MMAE using a cleavable linker.

Upon binding of ozuriftamab vedotin to ROR2 on the surface of tumor cells, it is internalized and the MMAE cytotoxin is released, thus killing the cancer cell.

We are prioritizing SCCHN for ozuriftamab vedotin as a therapeutic indication for development over other possible indications in solid tumors, including melanoma and triple negative breast cancer.

We have conducted Phase 2 studies in melanoma, NSCLC, and SCCHN treated with ozuriftamab vedotin as a monotherapy or in combination with a PD-1 inhibitor, nivolumab.

Both the monotherapy and combination treatment are broadly well tolerated with most events being low grade and reversible with no clinically meaningful on-target toxicity observed during the course of treatment.

Ozuriftamab vedotin has shown promising overall response rates in SCCHN and the FDA has granted Fast-Track designation for ozuriftamab vedotin in SCCHN.

We believe that 1.8 mg/kg of ozuriftamab vedotin delivered every other week satisfies dose optimization requirements, which will be confirmed prior to initiation of a Phase 3 study in SCCHN.

As a result, we may prioritize the larger, mutated KRAS NSCLC opportunity which shows high correlation with AXL expression, thereby utilizing an approved readily available companion diagnostic for KRAS mutations.

Both soft tissue and bone sarcoma, as well as other indications including mutated KRAS NSCLC, remain promising for potential future development through partnership with other companies.

Evalstotug (BA3071):

Our clinical stage product candidate, evalstotug, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering at least the efficacy of approved CTLA-4 antibodies, such as ipilimumab, but with lower toxicity rate as a result of the CAB’s unique tumor microenvironment-restricted binding.

Our clinical stage product candidate, evalstotug, is a CAB anti-CTLA-4 antibody that has been developed to the completion of Phase 1 and 2 as an immuno-oncology agent with the goal of delivering at least the efficacy of approved CTLA-4 antibodies, such as ipilimumab, but with lower toxicity rate as a result of the CAB’s unique tumor microenvironment-restricted binding.

Cytotoxic T-lymphocyte-associated antigen 4 (“CTLA-4”), is an immune checkpoint involved in regulating T-cell activation.

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Consequently, usage and dosage of these checkpoint inhibitors is highly limited due to their safety profile.

We are developing evalstotug as a potential therapeutic for solid tumor indications.

We have advanced evalstotug as a potential therapeutic for solid tumor indications.

We have completed a dose-escalation trial of evalstotug as monotherapy and in combination with an anti-PD-1 antibody.

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Most related adverse events in the Phase 1 and 2 were low grade with acceptable tolerability.

BA3182 (CAB-EpCAM x CAB-CD3):

Our bispecific candidate, BA3182, is currently being investigated in a Phase 1 dose escalation study in advanced adenocarcinoma.

We have leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor using dual CAB antigen-binding domains.

A bispecific antibody is a type of engineered antibody that can simultaneously bind two separate and unique antigens, unlike conventional monospecific antibodies that only bind to one type of target.

A common design feature for a bispecific antibody is to include a T cell engager component ( e.g.

, CD3 receptor), such that one antigen-binding domain recognizes a surface-expressed tumor antigen and the other antigen-binding domain binds to and activates CD3+ T cells.

There are many structural variants of antibodies and other antigen-binding domains being used by others to construct bispecific product candidates, some of which are being tested clinically.

We have applied our CAB antibody technology to develop bispecific CAB antibodies in which both antigen-binding domains are active only in the tumor microenvironment.

An example of this approach is our BA3182 bispecific.

Epithelial cell adhesion molecule (“EpCAM”) is a protein that is over-expressed in many cancers including carcinomas derived from colon, intestine, breast, lung and prostate.

Expression of EpCAM has been extensively associated with cell growth and proliferation of both healthy and cancer cells.

EpCAM was one of the first cancer-associated antigens discovered;

however, in the forty years since, its clinical impact as a target for therapeutic antibodies in cancer has been limited.

One of the problems with targeting EpCAM is its broad expression in the basolateral membranes of normal epithelial cells.

Bispecific constructs targeting EpCAM have also not lived up to expectations.

Over 20% of patients experienced dose-limiting toxicities, and at tolerated doses only one unconfirmed partial response was observed among 65 patients.

In our Phase 1 dose escalation study, we have observed several patients with tumor reduction, including one colorectal patient with stable disease for more than one year and we continue to dose escalate.

Preclinical candidates

We have several assets that are in varying stages of development and have been positioned for partnering.

BA3361 (CAB-Nectin-4-ADC)

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We believe that our CAB technology opens up the opportunity for the creation of a broad set of bispecific product candidates with antitumor potential.

Through these CAB bispecific antibodies, we believe we can activate T cells directly in tumors using CAB domains targeting tumor-specific antigens.

Through these CAB bispecific antibodies, we believe we can activate T cells directly in tumors while minimizing systemic activation.

We believe our CAB bispecific antibodies may allow for increased efficacy through more potent T cell activation, higher doses or administration in combination with other immuno-oncology therapies, such as checkpoint inhibitors.

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See further discussion in the Licensing and Strategic Collaboration section below.

These assets are in varying stages of development and have been positioned for partnering.

Our CAB technology

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Any product candidates that we successfully develop and commercialize may have to compete with existing therapies and new therapies that may become available in the future.

While we believe that our patented technology platform, intellectual property, know-how and scientific expertise in the field of biologics and immuno-oncology provide us with certain competitive advantages, including the ability of our product candidates to be active under conditions representative of the tumor microenvironment and not in normal cell conditions, we face potential competition from a wide variety of institutions, including large biopharmaceutical companies, specialty biotechnology companies, academic research departments and public and private research institutions.

While we believe that our patented

technology platform, intellectual property, know-how and scientific expertise in the field of biologics and immuno-oncology provide us with certain competitive advantages, including the ability of our product candidates to be active under conditions representative of the tumor microenvironment and not in normal cell conditions, we face potential competition from a wide variety of institutions, including large biopharmaceutical companies, specialty biotechnology companies, academic research departments and public and private research institutions.

In immuno-oncology, we face substantial competition in the form of competing approaches to targeted antibody therapy in general, as well as competing treatments for the same types of cancer that we would plan to address with our pipeline of product candidates.

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This integrated and efficient approach is designed to provide consistency of the folding, glycosylation and other critical features throughout the development and commercialization process for improved activity, selectivity and yields in manufacturing.

We currently do not own or operate any manufacturing facilities.

To date, we have been able to successfully manufacture our investigational product candidates for our ongoing early-stage clinical trials with contract manufacturers.

However, we currently do not own or operate any manufacturing facilities.

We rely and expect to continue to rely for the foreseeable future, on third-party contract manufacturing organizations to produce our product candidates for preclinical and clinical testing, as well as for commercial manufacture if our product candidates receive marketing approval.

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The BMS agreement was amended in October 2022 to include additional territories for our combination study trials for mecbotamab vedotin and ozuriftamab vedotin.

Global Co-Development and Collaboration Agreement with BeiGene, Ltd.

In April 2019, we entered into a Global Co-Development and Collaboration Agreement with BeiGene, Ltd.

which, as amended in December 2019 and October 2020, provided for the development, manufacturing and commercialization of BioAtla’s investigational CAB

CTLA-4 antibody, evalstotug (BA3071).

Under the terms of our BeiGene collaboration, BeiGene was generally responsible for developing evalstotug and for global regulatory filings and commercialization.

We received a total of $25 million in payments from BeiGene.

Global Co-Development and Collaboration Agreement with BeOne Medicines, Ltd.

In April 2019, we entered into a Global Co-Development and Collaboration Agreement with BeOne Medicines, Ltd.

(f/k/a BeiGene, Ltd.) (“BeOne”), which, as amended in December 2019 and October 2020, provided for the development, manufacturing and commercialization of BioAtla’s investigational CAB CTLA-4 antibody, evalstotug (BA3071).

Under the terms of our BeOne collaboration, BeOne was generally responsible for developing evalstotug and for global regulatory filings and commercialization.

We received a total of $25 million in payments from BeOne.

On November 19, 2021, we entered into Amendment No.

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Under Amendment No.

3, the collaboration agreement was terminated, subject to survival of certain provisions, and BeiGene handed back rights to certain know-how and materials received under the collaboration agreement and we assumed responsibility for the development and commercialization of evalstotug, in addition to other standard provisions.

3, the collaboration agreement was terminated, subject to survival of certain provisions, and BeOne handed back rights to certain know-how and materials received under the collaboration agreement and we assumed responsibility for the development and commercialization of evalstotug, in addition to other standard provisions.

As consideration for Amendment No.

3, we agreed to pay BeiGene mid single digit royalties on sales worldwide and on a limited basis will share in any upfront and milestone payments received through a sublicense of evalstotug.

3, we agreed to pay BeOne mid single digit royalties on sales worldwide and on a limited basis will share in any upfront and milestone payments received through a sublicense of evalstotug.

Amended and Restated Exclusive Rights Agreement with Himalaya Therapeutics SEZC

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License Agreement with Context Therapeutics Inc.

In September 2024, the Company entered into a License Agreement (the “Context License Agreement”) with Context Therapeutics Inc.

Under the terms of the Context License Agreement, BioAtla granted Context an exclusive, worldwide license to develop, manufacture and commercialize two licensed antibodies, including BA3362 (renamed by Context as CT-202), the Company’s Nectin-4 x CD3 T cell engaging (TCE) bispecific antibody (the “License”).

The Company also transferred know-how, including any necessary materials Context would need to perform research and development.

In exchange for the License, the Company is eligible to receive up to $133.5 million in aggregate payments, including an upfront cash payment and potential development, regulatory and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales of the products.

In September 2024, we entered into a License Agreement (the “Context License Agreement”) with Context Therapeutics Inc.

Under the terms of the Context License Agreement, BioAtla granted Context an exclusive, worldwide license to develop, manufacture and commercialize two licensed antibodies, including BA3362 (renamed by Context as CT-202), our Nectin-4 x CD3 T cell engaging (TCE) bispecific antibody (the “License”).

We also transferred know-how, including any necessary materials Context would need to perform research and development.

In exchange for the License, we are eligible to receive up to $133.5 million in aggregate payments, including an upfront cash payment and potential development, regulatory and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales of the products.

In connection with the execution of the Context License Agreement, the Company also entered into an agreement with Himalaya Therapeutics SECZ, a related party (See Note 10).

Investment Agreement with Inversagen AI

On December 30, 2025, we entered into an Investment Agreement (the “Investment Agreement”) with Inversagen AI, LLC, a Delaware limited liability company (“Inversagen AI”), and Alliance International Resources Corp., a Nevada corporation (“AIRC”).

Subject to completion of financings by Inversagen AI as set forth in the Investment Agreement, we agreed to sell common units in a subsidiary, BA 3021 SPV LLC (the “SPV”), to Inversagen AI in a private placement over multiple closings.

Upon completion of the transaction, Inversagen AI would own an aggregate 35% of the common units in the SPV in exchange for an aggregate $40 million.

Concurrently with the initial closing, we agreed to enter into an exclusive license agreement (the “License Agreement”) with the SPV in which we would grant to the SPV, an exclusive, worldwide, perpetual and irrevocable license to BioAtla’s intellectual property rights in ozuriftamab vedotin (“Oz-V”).

We agreed to grant the SPV the right to develop and commercialize Oz-V for all human uses, other than diseases (in all cases excluding oncology) in humans involving senescent cell

elimination therapy.

We planned to use the gross proceeds received from the sale of the SPV common units to Inversagen AI for general operating expenses and clinical trial expenses to advance Oz-V in the Phase 3 Study.

However, in connection with recent events, including the recently announced formal process to explore and evaluate strategic options and related workforce reduction, the transaction has not closed and the timing of completing the transaction and initiation of the Phase 3 Study are being re-evaluated, and we are in discussions to potentially restructure the transaction pending the outcome of the strategic process.

As discussed in Note 10 of our consolidated financial statements, Inversagen, LLC holds an exclusive license to CAB senescence and longevity technologies from the Company.

Inversagen, LLC subsequently contributed these rights to Inversagen AI.

Inversagen, LLC and Inversagen AI are deemed to be related parties of the Company.

Intellectual property

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Mecbotamab vedotin is covered by many filings, including a published PCT application filed in 2017 that entered the national phase in 2018.

Applications have been granted in Australia, Israel, Japan, Korea, Mexico, Singapore, Taiwan, and the United States and are pending in 13 jurisdictions, including most major market countries.

Applications have been granted in Albania, Australia, Canada, Croatia, Cyprus, Czech Republic, Europe, Greece, Hungary, Israel, India, Japan, Korea, Macedonia (former Yugoslav Republic), Malta, Mexico, Monaco, Norway, Poland, San Marino, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, the United Kingdom and the United States and are pending in 8 jurisdictions, including most major market countries.

Composition of matter claims issuing from this application would not expire before 2037.

Ozuriftamab vedotin is covered by many filings, including a published PCT application filed in 2017 that entered the national phase in 2018.

Applications have been granted in Australia, Europe, Israel, India, Japan, Korea, Mexico, Taiwan and the United States and are pending in 134 jurisdictions, including most major market countries.

Applications have been granted in Albania, Australia, Belgium, Bulgaria, China, Croatia, Cyprus, Czech Republic, Europe, Germany, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Israel, India, Italy, Japan, Korea, Lithuania, Luxembourg, Latvia, Macedonia (former Yugoslav Republic), Malta, Mexico, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Turkey, the United Kingdom and the United States and are pending in 13 jurisdictions, including most major market countries.

Composition of matter claims issuing from this application would not expire before 2037.

Evalstotug is covered by many filings, including a published PCT application filed in 2019 that entered the national phase in 2021.

Applications have been granted in Australia, Canada, Israel, Japan, Korea, New Zealand, Russia and the United States and are pending in 16 jurisdictions, including most major market countries.

Applications have been granted in Australia, Canada, Israel, Japan, Korea, New Zealand, Russia, Singapore, Taiwan and the United States and are pending in 16 jurisdictions, including most major market countries.

Composition of matter claims issuing from this application would not expire before 2039.

Our CAB-anti-EpCAM antibody and our preclinical stage CAB-anti-Nectin-4 antibody, are covered by many filings.

As of January 1, 2024, CAB-anti-EpCAM antibodies are covered by 13 national phase filings, including in the United States, an additional PCT application and two non-PCT filings in Taiwan.

As of January 1, 2024, CAB-anti-Nectin-4 antibodies are covered by 12 national phase filings and an application in Taiwan.

Composition of matter claims issuing from these applications would not expire before either 2040 or 2044.

Our CAB-anti-EpCAM antibody is covered by many filings, including a published PCT application filed in 2020 that entered the national phase in 2022.

Applications have been granted in Australia, China, Hong Kong, Israel, Japan, Korea, Taiwan and the United States and are pending in 6 jurisdictions, including most major market countries.

Composition of matter claims issuing from this application would not expire before 2040.

Our CAB-anti-Nectin-4 antibodies are covered by many filings, including 12 national phase filings and a granted and pending application in Taiwan.

Composition of matter claims issuing from these applications would not expire before 2044.

Core components of our product candidates are protected by company-owned platform applications directed to novel methods of protein evolution, methods of making conditionally active biologics, integrated selection and evolution of antibodies and proteins in expression production hosts, multi-specific antibodies and methods of making, modified antibody regions, conditionally active biological proteins, proteins targeting orthologs, discovery of and production of conditionally active biologic proteins in eukaryotic cell production hosts, conditionally active chimeric antigen receptors for modified T-cells, diagnostics using conditionally active antibodies, conditionally active polypeptides, antibodies targeted to senescent cells, conditionally active proteins for neurodegenerative diseases, and conditionally active proteins with pH selectivity.

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In September 2024, the Company granted Context Therapeutics an exclusive worldwide license to develop, manufacture, and commercialize two licensed antibodies, including a CAB Nectin-4 x CD3 T-Cell engaging bispecific antibody, and non-exclusive rights to BioAtla's enabling technology to the extent necessary to exploit the licensed antibodies.

See Note 7 to our financial statements for further details.

See Note 9 to our consolidated financial statements for further details.

BioAtla Holdings, LLC has exclusive worldwide rights to all patents for the field of adoptive cell immunotherapy “ACT” (chimeric antigen receptor (CAR) T-cell (“CAR-T”)), excluding the targets licensed to EXUMA Biotech Corp (“EXUMA”).

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In the case of some product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

Typically, during the development of oncology therapies, all subjects enrolled in Phase 1 clinical trials are disease-affected patients and, as a result, considerably more information on clinical activity may be collected during such trials than during Phase 1 clinical trials for non-oncology therapies.

The biologic product candidate is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product candidate a particular indication and to determine dosage tolerance, optimal dosage and dosing schedule.

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These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and labeling.

In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of a biologic.

These phases may overlap or be combined.

For example, a Phase 1/2 clinical trial may contain both a dose-escalation stage and a dose-expansion stage, the latter of which may confirm tolerability at the recommended dose for expansion in future clinical trials (as in traditional Phase 1 clinical trials) and provide insight into the antitumor effects of the investigational therapy in selected subpopulation(s).

A single Phase 3 or Phase 2 trial may be sufficient in rare instances, including (i) where the trial is a large, multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible or (ii) when in conjunction with other confirmatory evidence.

In many cases, particularly for prevalent diseases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of a biologic.

A single Phase 3 or Phase 2 trial may be sufficient in many other conditions, particularly for rare disease therapies, when in conjunction with confirmatory evidence.

A single adequate and well-controlled trial may also be sufficient, though it is less common, when the trial is a large, multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.

Approval on the basis of a single trial may be subject to the requirement of additional post-approval studies.

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Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.

Additionally, no user fees are

assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The applicant under an approved BLA is also subject to an annual program fee.

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A REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use (“ETASU”).

ETASU can include, but are not limited to, special training or certification for prescribing or dispensing the product, dispensing the product only under certain circumstances, special monitoring, and the use of patient-specific registries.

ETASU can include, but are not limited to, special training or certification for prescribing or dispensing the product,

dispensing the product only under certain circumstances, special monitoring, and the use of patient-specific registries.

If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS;

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Even if such data and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval.

The FDA has agreed to specified performance goals in the review of BLAs under the PDUFA.

The FDA has agreed to specified performance goals in the review of BLAs under PDUFA.

One such goal is to review standard BLAs within 10 months after the FDA files the BLA, and priority BLAs within six months, whereupon a review decision is to be made.

The review process and the PDUFA goal date for both standard and priority review BLAs may be extended by three months if the FDA requests or the BLA sponsor otherwise provides additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date.

The review process and the PDUFA goal date for both standard and priority review BLAs may be extended by three months if the FDA deems information submitted by the applicant to be a major amendment to the BLA.

If a product candidate receives regulatory approval, the FDA may require post-marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biologic product’s safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

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The FDA will attempt to direct additional resources to the evaluation of an application designated for priority review in an effort to facilitate the review.

Accelerated approval may be granted for products that are intended to treat a serious or life-threatening condition and that generally provide a meaningful therapeutic advantage to patients over existing treatments.

Accelerated approval may be granted for products that are intended to treat a serious or life-threatening condition and that generally address an unmet medical need.

A product eligible for accelerated approval may be approved on the basis of either 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.

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All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.

The Food and Drug Omnibus Reform Act (“FDORA”) included provisions related to the accelerated approval pathway.

Pursuant to FDORA, the FDA is authorized to require a post-approval study to be underway prior to approval or within a specified time period following approval.

FDORA also requires the FDA to specify conditions of any required post-approval study, which may include milestones such as a target date of study completion and requires sponsors to submit progress reports for required post-approval studies and any conditions required by the FDA not later than 180 days following approval and not less frequently than every 180 days thereafter until completion or termination of the study.

FDORA enables the FDA to initiate enforcement action for the failure to conduct with due diligence a required post-approval study, including a failure to meet any required conditions specified by the FDA or to submit timely reports.

The FDA is authorized to require a post-approval study to be underway prior to approval or within a specified time period following approval.

The FDA must also specify conditions of any required post-approval study, which may include milestones such as a target date of study completion.

Sponsors must submit progress reports for required post-approval studies and any conditions required by the FDA not later than 180 days following approval and not less frequently than every 180 days thereafter until completion or termination of the study.

The FDA can initiate an enforcement action for the failure to conduct with due diligence a required post-approval study, including a failure to meet any required conditions specified by the FDA or to submit timely reports.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened.

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In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.

Other post-approval requirements applicable to biologic products include reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product, record-keeping requirements, reporting of adverse effects, reporting updated safety and efficacy information and complying with electronic record

and signature requirements.

A sponsor also must comply with the FDA’s advertising and promotion requirements, such as those related to direct-to-consumer advertising, the prohibition on promoting products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label use”), industry-sponsored scientific and educational activities and promotional activities involving the internet.

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Orphan drug designation in the United States is designed to encourage sponsors to develop products intended for treatment of rare diseases or conditions.

In the United States, pursuant to the Orphan Drug Act, the FDA may grant orphan designation to a biological product intended to treat a rare disease or condition, which is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available the biologic for the disease or condition will be recovered from sales of the product in the United States.

An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product.

The Office of Orphan Products Development at the FDA grants orphan drug designations based on acceptable confidential requests made under the regulatory provisions.

In the United States, pursuant to the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available the biologic for the disease or condition will be recovered from sales of the product in the United States.

An application for designation as an orphan product can be made any time prior to the submission of an application for approval to market the product.

The Office of Orphan Products Development at the FDA grants orphan drug designations based on acceptable confidential requests

made under the regulatory provisions.

The product must then go through the review and approval process like any other product.

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A sponsor may request orphan drug designation of a previously unapproved product or new orphan indication for an already marketed product.

In addition, a sponsor of a product that is otherwise the same drug, which includes biologics, as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first drug.

In addition, a sponsor of a product that is otherwise the same drug, which includes biologics, as an already approved orphan-designated drug may seek and obtain orphan drug designation for a subsequent product for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first drug.

More than one sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but each sponsor seeking orphan drug designation must file a complete request for designation.

If a product with orphan designation receives the first FDA approval of the drug to treat the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product generally will receive orphan drug exclusivity.

Orphan drug exclusivity means that the FDA may not approve another sponsor’s marketing application for the same drug for the same indication for seven years, except in certain limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care, or in instances of product supply issues.

In the case of a biological product, the same drug is a drug that contains the same principal molecular features, except if it is clinically superior.

A product is clinically superior if it is safer, more effective, or makes a major contribution to patient care.

If a product designated as an orphan drug ultimately receives marketing approval for an indication broader than what was designated in its orphan drug application, it may not be entitled to orphan drug exclusivity.

Competitors may receive approval of either a different drug for the same indication or the same drug for a different indication.

The period of exclusivity begins on the date that the marketing application is approved by the FDA and applies only to the indication for which the product has been designated and approved.

The FDA may approve a second application for the same drug for a different use or a second application for a clinically superior version of the drug for the same use.

The FDA may approve a second application for the same drug for a different indication, a different drug for the same indication, or a second application for a clinically superior version of the same drug for the same indication.

Because healthcare professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite another product’s orphan exclusivity.

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In the United States, the FDCA and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import, and post-market surveillance.

Unless an exemption applies, diagnostic tests require marketing clearance or approval from the FDA prior to commercial distribution.

Unless an exemption applies, diagnostic tests require marketing clearance, authorization, or approval from the FDA prior to commercial distribution.

The two primary types of FDA marketing authorization applicable to a medical device are premarket notification, also called 510(k) clearance, and premarket approval, or PMA.

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In particular, for a diagnostic, the applicant must demonstrate that the diagnostic has adequate sensitivity and specificity, has adequate specimen and reagent stability, and produces reproducible results when the same sample is tested multiple times by multiple users at multiple laboratories.

As part of the PMA review, the FDA will typically inspect the manufacturer’s facilities for compliance with the Quality System Regulation (“QSR”), which imposes elaborate testing, control, documentation and other quality assurance requirements.

As part of the PMA review, the FDA will typically inspect the manufacturer’s facilities for compliance with the Quality Management System Regulation (“QMSR”), which imposes elaborate testing, control, documentation and other quality assurance requirements.

PMA approval is not guaranteed, and the FDA may ultimately respond to a PMA submission with a not approvable determination based on deficiencies in the application and require additional clinical trial or other data that may be expensive and time-consuming to generate and that can substantially delay approval.

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Once granted, PMA approval may be withdrawn by the FDA if compliance with post approval requirements, conditions of approval or other regulatory standards are not maintained or problems are identified following initial marketing.

In 2024, FDA’s Center for Devices and Radiological Health (“CDRH”) announced that it intended to reclassify most high-risk in vitro diagnostic products from Class III to Class II medical devices and stated that it expected most future companion diagnostics would be regulated as Class II devices.

Reclassification would allow companion diagnostic developers to seek marketing authorization through the FDA’s 510(k) or de novo classification pathways rather than the more costly and time-consuming PMA pathway.

Since that time, CDRH has taken steps to begin the reclassification process for certain companion diagnostic products, such as in situ hybridization test systems and nucleic acid-based test systems intended for use with a corresponding approved oncology therapeutic product.

However, these proposed reclassifications are not yet final and commercializing any such tests requires PMA approval until the reclassification is final.

The 510(k) and de novo submission processes are less burdensome than the PMA approval process.

To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a legally marketed device, referred to as the predicate device.

To be substantially equivalent, the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and be shown to be equally safe and effective and not raise different questions of safety and effectiveness than the predicate device.

The de novo classification process is used when there is no predicate device.

In a de novo submission, the sponsor must demonstrate that the proposed device is of low or moderate risk and the benefits outweigh the risks.

The type of data included in a de novo request is similar to the type of data included in a 510(k), although a larger proportion of de novo submissions require clinical data as compared to 510(k)s.

The review time for a de novo request is longer as compared to the 510(k) process, and the outcome for de novo requests is more uncertain.

After a device is placed on the market, it remains subject to significant regulatory requirements.

Medical devices may be marketed only for the uses and indications for which they are cleared or approved.

Medical devices may be marketed only for the uses and indications for which they are cleared, authorized, or approved.

A modification that could significantly affect a device’s safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance, de novo authorization, or could require a PMA approval.

Device manufacturers must also register their establishments and list their devices with the FDA.

A medical device manufacturer’s manufacturing processes, and the processes of the device specification developer and repackager/relabeler (if different from the manufacturer) and initial importer (if manufactured outside of the United States) are required to comply with the applicable portions of the QSR, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, importation, labeling, packaging and shipping of medical devices.

A medical device manufacturer’s manufacturing processes, and the processes of the device specification developer and repackager/relabeler (if different from the manufacturer) and initial importer (if manufactured outside of the United States) are required to comply with the applicable portions of the QMSR, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, importation, labeling, packaging and shipping of medical devices.

Facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA.

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The FDA may grant deferrals for submission of data or full or partial waivers.

and is a molecularly targeted cancer product intended for the treatment of an adult cancer and is directed at a molecular target that FDA has determined is substantially relevant to the growth or progression of a pediatric cancer.

Unless otherwise required by regulation, the PREA generally does not apply to any biologic product candidate for an indication for which orphan designation has been granted with the exception of orphan-designated biologics if the product contains a new active ingredient and is a molecularly targeted cancer product intended for the treatment of an adult cancer and is directed at a molecular target that FDA has determined is substantially relevant to the growth or progression of a pediatric cancer.

The Best Pharmaceuticals for Children Act (“BPCA”) provides a six-month extension of any non-patent exclusivity for a biologic if certain conditions are met.

Conditions for exclusivity include the FDA’s determination that information relating to the use of a new biologic in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe.

Conditions for exclusivity include the FDA’s determination that information relating to the use of a new biologic in the

pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies that fairly respond to the written request within the statutory timeframe.

Applications under the BPCA are treated as priority applications, with all of the benefits that designation confers.

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The FDA has licensed many biosimilars under the BPCIA, and has issued several guidance documents outlining an approach to review and approval of biosimilars.

Biosimilarity, which requires that there be no differences in conditions of use, route of administration, dosage form, and strength, and no clinically meaningful differences between the proposed biosimilar biological product and the reference product in terms of safety, purity and potency, can be shown through analytical studies, an assessment of toxicity, and a clinical trial or studies though the FDA has broad discretion to set or waive certain biosimilar licensure data requirements.

Biosimilarity, which requires that there be no differences in route of administration, dosage form, and strength, and no clinically meaningful differences between the proposed biosimilar biological product and the reference product in terms of safety, purity and potency, can be shown through analytical studies, an assessment of toxicity, and a clinical trial or studies though the FDA has broad discretion to set or waive certain biosimilar licensure data requirements.

Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

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At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

The first biologic product submitted under the biosimilar abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against approval of an interchangeable biologic for the same condition of use for the earlier of (i) one year after first commercial marketing of the first interchangeable biosimilar, (ii) 18 months after the first interchangeable biosimilar is approved if there is no patent challenge, (iii) eighteen months after resolution of a lawsuit over the patents of the reference biologic in favor of the first interchangeable biosimilar applicant, or (iv) 42 months after the first interchangeable biosimilar’s application has been approved if a patent lawsuit is ongoing within the 42-month period.

The first biologic product submitted under the biosimilar abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against approval of an interchangeable biologic for the same condition of use for the earlier of (i) one year after first commercial marketing of the first interchangeable biosimilar, (ii) 18 months after the first interchangeable biosimilar is approved if there is no patent challenge, (iii) 18 months after resolution of a lawsuit over the patents of the reference biologic in favor of the first interchangeable biosimilar applicant, or (iv) 42 months after the first interchangeable biosimilar’s application has been approved if a patent lawsuit is ongoing within the 42-month period.

Patent term restoration and extension

In the United States, a patent claiming a new biologic product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch-Waxman Act, which permits a patent extension of up to five years for patent term lost during product development and FDA regulatory review.

Assuming grant of the patent for which the extension is sought, the restoration period for a patent

covering a product is typically one-half the time between the effective date of the IND involving human beings and the submission date of the BLA, plus the time between the submission date of the BLA and the ultimate approval date.

Assuming grant of the patent for which the extension is sought, the restoration period for a patent covering a product is typically one-half the time between the effective date of the IND involving human beings and the submission date of the BLA, plus the time between the submission date of the BLA and the ultimate approval date.

Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years from the product’s approval date in the United States.

Only one patent applicable to an approved product is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent for which extension is sought.

Only one patent applicable to an approved product is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent for

which extension is sought.

A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals.

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Pursuant to Regulation (EC) No.

726/2004, the centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of cancer.

products and products with a new active substance indicated for the treatment of certain diseases, including products for the treatment of cancer.

For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure is optional.

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These include compliance with the European Union’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed.

In addition, the manufacturing of authorized products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the EMA’s good manufacturing practices (“GMP”) requirements and comparable requirements of other regulatory bodies in the European Union, which mandate the methods, facilities and controls used in the manufacturing, processing and packing of drugs to assure their safety and identity.

In addition, the manufacturing of authorized products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict

compliance with the EMA’s good manufacturing practices (“GMP”) requirements and comparable requirements of other regulatory bodies in the European Union, which mandate the methods, facilities and controls used in the manufacturing, processing and packing of drugs to assure their safety and identity.

Finally, the marketing and promotion of authorized products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union under Directive 2001/83EC, as amended.

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Department of Health and Human Services (“HHS”) (e.g., the Office of Inspector General and the Office for Civil Rights), the U.S.

Department of Justice (the

“DOJ”), and individual U.S.

Department of Justice (the “DOJ”), and individual U.S.

Attorney offices within the DOJ, and state and local governments.

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The CCPA went into effect on January 1, 2020 and requires covered companies to provide new disclosures to California consumers, provide such consumers new ways to opt-out of certain sales of personal information, and allow for a new cause of action for data breaches.

On November 3, 2020, California voters approved a new privacy law, the California Privacy Rights Act (the “CPRA”), which significantly modifies the CCPA, including by expanding consumers’ rights with respect to certain personal information and creating a new state agency to oversee implementation and enforcement efforts.

On November 3, 2020, California voters approved a new privacy law, the California Privacy Rights Act (the “CPRA”), which imposes additional obligations on covered companies and significantly modifies the CCPA, including by expanding consumers’ rights with respect to certain personal information and creating a new state agency to oversee implementation and enforcement efforts.

The CCPA and CPRA provide for unlimited civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.

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government rebate programs and additional downward pressure on pharmaceutical product prices.

Several healthcare reform proposals culminated in the enactment of the Inflation Reduction Act of 2022 (the “IRA”) in August 2022, which, among other things, allows HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

Several healthcare reform proposals culminated in the enactment of the Inflation Reduction Act of 2022 (the “IRA”) in August 2022, which, among other things, requires HHS to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D.

The negotiated price may not exceed a statutory ceiling price.

Only high-expenditure single-source biologics that have been approved for at least 11 years (7 years for drugs) can be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

Only high-expenditure single-source biologics that have been approved for at least 11 years (7 years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year.

For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations took place in 2024, and the negotiated maximum fair price for each product has been announced.

CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.

For 2028, an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, 20 Part B or Part D drugs will be selected.

A drug or biological product that has an orphan drug designation for only one rare disease or condition will be excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it receives designations for more than one rare disease or condition, or if it is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation.

In addition, CMS has selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs, which will become effective in 2027.

For 2028, CMS has selected an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B.

For 2029 and subsequent years, 20 Part B or Part D drugs will be selected.

Currently, a drug or biological product that has an orphan drug designation for only one rare disease or condition will be excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it receives designations for more than one rare disease or condition, or if it is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation.

However, as a result of a statutory amendment enacted in July 2025, beginning with the 2028 negotiated price applicability year, a drug may be designated

for more than one rare disease or condition and still be excluded from price negotiation, as long as the only approved indications are for such rare diseases or conditions.

The IRA also imposes rebates on Medicare Part B and Part D drugs whose prices have increased at a rate greater than the rate of inflation, and in November 2024, CMS finalized regulations for the Medicare Part B and Part D inflation rebates.

The IRA also extends enhanced subsidies for individuals

purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

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Additional state and federal healthcare reform measures could be adopted in the future.

The federal administration is pursuing executive and regulatory actions directing HHS to pursue most favored nation (“MFN”) pricing targets for prescription drugs and to evaluate other potential reforms including, for example, an executive order tasking the Center for Medicare and Medicaid Innovation (“CMMI”) to consider new payment and healthcare models to limit drug spending, and promote MFN drug pricing, among other directives.

For example, on December 23, 2025, CMS issued proposed regulations to establish, under CMMI, two mandatory MFN demonstration models under Medicare Parts B and D, respectively.

If these rules or other MFN pricing rules are finalized, they are likely to reduce prices of at least some drugs in the United States, if they are also sold in comparator countries.

Even if a company does not market drugs in such countries, the company could be indirectly affected if its drugs compete with drugs whose prices were reduced as a result of MFN pricing initiatives.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and in some cases, designed to encourage importation from other countries and bulk purchasing.

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As of December 31, 2025, we employed 41 employees.

We also engaged 15 independent contractors located in China as of December 31, 2024 pursuant to our relationship with BioDuro-Sundia, a U.S.-based provider of preclinical development services.

None of our employees are subject to a collective bargaining agreement.

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In addition to our benefits, we offer wellness and stress management support which includes an on-site gym, company-wide wellness activities, wellness resources that are shared with employees each month, an Employee Assistance Program with counseling, and flexible work arrangements.

Inclusion and Belonging .

We believe that an equitable and inclusive environment with diverse teams produces more creative solutions, results in better, more innovative products and services and is crucial to our efforts to attract and retain key talent.

Our current efforts are focused on four primary areas:

• Employee well-being.

We believe everyone plays a crucial role in fostering a safe and healthy workplace.

With employees in diverse roles and functions, we empower them to contribute to a safe working environment, whether they are in a lab or office.

Our policies and practices are designed to not only protect our employees but also to safeguard the surrounding communities where we work.

• Safe work environment.

We provide training to all employees to improve their understanding of behaviors that can be perceived as discriminatory, exclusionary, and/or harassing, and provide safe avenues for employees to report such behaviors.

• Equal employment opportunity.

We ensure that our practices and processes attract a diverse range of candidate, and that candidates are recruited, hired, paid, assigned, developed, and promoted based on merit and their alignment to our values.

• Learning and development opportunities.

To support our employees in reaching their full potential, we offer a wide range of internal and external learning and development opportunities to support a culture of learning.

• Community Involvement.

We aim to give back to the communities where we live and work, and believe that this commitment helps in our efforts to attract and retain employees.

We work with local universities to introduce and promote careers in science and biotechnology through internship opportunities.

Employee Communication and Engagement.

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The SEC maintains an internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.

Recent Developments

Restructuring

On March 2, 2026, the Company announced that it has initiated a formal process to explore and evaluate strategic options to maximize shareholder value, including sale of preclinical and clinical assets, licensing transactions, strategic partnerships or other corporate transactions.

In connection with the evaluation of strategic alternatives, the Company is implementing a restructuring plan that includes a workforce reduction of approximately 70%.

Merger and Related Share Consolidation

On March 23, 2026, the Company’s stockholders approved the Agreement and Plan of Merger, as amended from time to time, including pursuant to Amendment No.

1 to Agreement and Plan of Merger, pursuant to which (i) a wholly owned subsidiary (the “Merger Sub”) of the Company will merge with and into the Company, with the Company surviving (the “Merger”), and (ii) every fifty (50) shares of common stock of the Company issued and outstanding, or held as treasury stock, will be converted into one (1) share of common stock of the surviving corporation, which shall be the Company (the “Share Consolidation”).

The Share Consolidation will not change the number of authorized shares of common stock.

Common stock share and per share data, and exercise price data for applicable common stock equivalents, included in these financial statements have not been retroactively adjusted to reflect the Share Consolidation as the Merger has not yet been consummated.

The Company plans to effect the Merger and the Share Consolidation as soon as possible subject to required Nasdaq notice periods.

The effective date of the Merger is expected to be April 6, 2026.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business