What changed in this filing

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Item 1. Business

2026-03-27 compared with 2025-03-11 · 186 added, 208 removed, 813 unchanged (33% of the section changed)

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We are leveraging our proprietary PREDATOR platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies.

Our molecules, which we refer to as INDUKINE molecules, are intended to activate selectively in the tumor microenvironment, or TME.

Our molecules, which we refer to as INDUKINE and INDUCER molecules, are intended to activate selectively in the tumor microenvironment, or TME.

Our most advanced product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12), respectively, INDUKINE molecules for the treatment of multiple tumor types.

We are also utilizing this PREDATOR platform know-how and expertise to develop conditionally activated immune cell engagers.

Immune cell engagers, such as T cell engagers, are typically bispecific antibodies that redirect immune cells to cancer cells via engagement with tumor associated cell surface antigens, leading to immune cell mediated killing of the cancer cells.

We have provided initial preclinical data for our proprietary INDUCER™ T cell engager molecules demonstrating that our PREDATOR masking technology silenced peripheral activity and prevented cytokine release.

In February 2026, we adopted a restructuring plan to extend our capital resources in connection with initiating a process to explore a full range of strategic alternatives to advance our promising platform and drug development pipeline to maximize stockholder value.

We have engaged Piper Sandler & Co, or Piper Sandler, to serve as exclusive financial advisor to assist in the strategic review process.

Measures contemplated during the strategic review process may include, among other options, a sale of our company, a business combination or merger, a sale of our assets, licensing or collaboration arrangements, or other strategic transactions.

There can be no assurance that the strategic review process will result in any agreement or transaction that will enhance stockholder value, or any agreement or transaction at all.

As part of the restructuring plan, our board of directors approved a reduction in force, representing 64% of our workforce, to better align our resources with our pursuit of strategic alternatives.

As a result of the reduction in force, we estimate that we will incur a one-time charge in the first quarter of 2026 related to employee separation benefits, including severance and related benefits, of approximately $4.1 million, most of which is anticipated to result in cash expenditures to be incurred in the first quarter of 2026.

We may also incur additional costs, including, but not limited to, potential impairment charges not currently contemplated due to events that may occur as a result of, or that are associated with, the restructuring plan.

The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates.

We are currently evaluating WTX-124 in a Phase 1/1b clinical trial as a monotherapy and in combination with Merck & Co., Inc.’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with immunotherapy sensitive advanced or metastatic solid tumors who have failed standard of care treatment, including checkpoint inhibitor therapy.

In November 2023, we announced preliminary first-in-human clinical data from the initial monotherapy dose-escalation cohorts in the Phase 1/1b clinical trial establishing proof of mechanism for WTX-124 and proof of concept for our INDUKINE design, and included assessments of safety and tolerability, pharmacokinetics, relevant biomarkers and preliminary antitumor activity.

In June 2024, we reported updated interim data from the monotherapy dose-escalation arms of the Phase 1/1b clinical trial, selected a recommended dose for expansion and initiated monotherapy dose expansion arms, and reported initial data from the combination dose escalation cohorts of the Phase 1/1b clinical trial.

We completed the dose-escalation phase of our Phase 1/1b clinical trial and continue to enroll patients in the monotherapy and combination expansion arms of the Phase 1/1b clinical trial.

We have targeted full enrollment in the monotherapy dose expansion arm in the first half of 2025 and in the combination arm in the second half of 2025.

We plan to meet with regulatory authorities to discuss potential registrational pathways in the second half of 2025 and to release a monotherapy and combination therapy clinical data update in the fourth quarter of 2025.

We have evaluated WTX-330 in a Phase 1 clinical trial for the treatment of immunotherapy resistant advanced or metastatic solid tumors or lymphoma.

We reported initial data from the Phase 1 clinical trial in June 2024 and presented updated interim safety and efficacy data from the Phase 1 clinical trial at the Society for Immunotherapy of Cancer Annual Meeting held in November 2024, highlighting the tolerability profile and monotherapy efficacy signals of WTX-330.

Guided by these data, we expect to initiate a Phase 1/2 dose and regimen-finding clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors.

In June 2024, we reported updated interim data from the monotherapy dose-escalation arms of the Phase 1/1b clinical trial, selected a recommended dose for expansion, initiated monotherapy dose expansion arms, and reported initial data from the combination dose escalation cohorts of the Phase 1/1b clinical trial.

In December 2025, we reported that WTX-124 initial Phase 1b expansion arm data showed a 21% objective response rate as a monotherapy in heavily pretreated patients with advanced or metastatic cutaneous melanoma and a 30% objective response rate in patients who were not primary resistant to immunotherapy, with no evidence of vascular leak syndrome or recurrence of prior immune-related adverse events.

We evaluated WTX-330 in a first-in-human Phase 1 clinical trial for the treatment of immunotherapy resistant advanced or metastatic solid tumors or lymphoma.

Phase 1 of this clinical trial was completed in the first quarter of 2025.

We reported initial data from the Phase 1 clinical trial in June 2024 and presented updated interim safety and efficacy data from the Phase 1 clinical trial at the Society for Immunotherapy of Cancer Annual Meeting in November 2024, highlighting the tolerability profile and monotherapy efficacy signals of WTX-330.

Guided by these data, we initiated a Phase 1b/2 clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors.

In December 2025, we reported evidence of favorable tolerability and antitumor activity, with one confirmed partial response in metastatic gall bladder cancer failing prior standard of care with a 45% reduction in tumor target lesions by RECIST 1.1.

We have licensed the worldwide right to develop and commercialize JZP898, formerly WTX-613, a differentiated, conditionally activated Interferon alpha, or IFNα, INDUKINE molecule, to Jazz Pharmaceuticals Ireland Limited, or Jazz.

We continue to further the development of our preclinical product candidates, WTX-712, WTX-518, and WTX-921.

WTX-712 is a systemically delivered, conditionally activated Interleukin-21 (IL-21) INDUKINE molecule that is being developed to minimize the severe toxicities that have been observed with recombinant IL-21 therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors in refractory and/or immunologically unresponsive

Our preclinical product candidates include WTX-712, WTX-518, WTX-921, WTX-1011, and WTX-2022.

In April 2024, we presented preclinical data for WTX-712 at the American Association for Cancer Research, or AACR, annual meeting demonstrating that WTX-712 acts through a unique mechanism that robustly activates tumor-specific T lymphocytes with an expanded therapeutic window through its selective release of wild-type IL-21 in the TME.

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WTX-921 is a systemically delivered, conditionally activated Interleukin-10 (IL-10) INDUKINE molecule in development for the treatment of inflammatory bowel disease, or IBD, and potentially other inflammatory diseases.

We continue to build our PREDATOR platform to generate a pipeline of innovative therapeutics that cover a diversity of immune stimulating mechanisms with the potential to address significant unmet medical need in therapeutic areas including new immuno-oncology, autoimmune, and inflammatory diseases.

Our PREDATOR platform consists of our protein engineering technologies and our know-how, which we use to generate INDUKINE molecules with multiple functional domains rationally engineered into a single protein to achieve the desired pharmaceutical profile.

Each of our lead INDUKINE molecules consists of four components:

a cytokine, an inactivation domain, a half-life extension domain and a proprietary protease-cleavable linker.

Our INDUKINE molecules for oncology contain cytokines that mediate pro-inflammatory, anti-cancer mechanisms within the TME, with full potency and functionality observed in preclinical studies.

The inactivation domain physically blocks the cytokine portion of the INDUKINE molecule in non-tumor tissue throughout the body, or the periphery, preventing it from binding to its receptor until it is cleaved and thereby activated in the TME.

The half-life extension domain enables high systemic and tumor tissue exposure for the INDUKINE molecule prior to its cleavage in the tumor.

After cleavage in the tumor, the half-life extension domain is removed, and the cytokine is released to activate immune cells.

We select the proprietary protease-cleavable linker to enable conditional release of the cytokine portion of the INDUKINE molecule within tumor tissue.

This selection is based on our extensive screening in preclinical studies to identify protease-cleavable linkers that are efficiently cleaved by a broad array of human tumor tissues with minimal cleavage in non-tumor tissues.

We are leveraging our novel PREDATOR platform to engineer conditionally activated proinflammatory immunomodulators, or INDUKINE molecules, which are delivered systemically but activated only in the TME, with the goal of generating potent antitumor response while minimizing toxicities.

Except for JZP898, which we have licensed to Jazz, we have worldwide rights to our PREDATOR platform and our portfolio of INDUKINE product candidates, all of which we have developed internally.

We believe our approach has the potential to overcome current limitations of systemic proinflammatory immunomodulatory

therapies, such as cytokines, for the treatment of cancer and other immune-mediated conditions.

Our current pipeline is summarized below:

Using our PREDATOR platform, we have identified and are continuing to develop five initial product candidates:

WTX-124, WTX-330, WTX-712, WTX-518, and WTX-921.

In addition to these product candidates, we are pursuing additional immuno-oncology discovery programs in which we are applying our novel engineering approach to other targets.

We are also expanding our technology to other disease areas, such as inflammatory diseases.

Our goal is to utilize our proprietary PREDATOR platform to redefine the cancer treatment landscape with therapies to transform the lives of cancer patients, as well as to continue to develop our preclinical portfolio for the treatment of inflammatory bowel disease and potentially other inflammatory diseases.

Key elements of our strategy include:

• Advancing our lead product candidate, WTX-124, through clinical development in selected solid tumor indications.

• Advancing WTX-330 through clinical development in selected solid tumors and lymphoma.

• Advancing WTX-712, WTX-518, and WTX-921 through preclinical development.

• Establishing a leading position in protein engineering and developing optimized conditionally activated molecules.

• Selectively entering into strategic partnerships while retaining key rights to our programs and platform in major pharmaceutical markets.

In May 2025, we presented preclinical data for WTX-921 at the American Association of Immunologists, or AAI, annual meeting demonstrating the potential of WTX-921 to modulate disease-driving innate and adaptive immune responses.

Our INDUCER molecules incorporate several differentiating features to address the limitations of other T-cell engager approaches by improving the therapeutic index, enhancing INDUCER exposure in the target tissue, and careful selection of tumor associated antigens that have the potential for preferential tumor association compared to normal tissue.

INDUCER molecules utilize a proprietary masking approach and the same novel linker technology that has been clinically validated in the WTX-124 and WTX-330 programs.

The preliminary preclinical data on our first development candidate, WTX-1011, targeting STEAP1 were consistent with preclinical data from our second development candidate, WTX-2022, that targets the CDH6 tumor associated antigen.

Preclinical data for each candidate demonstrated the power of the INDUCER technology with robust silencing, reversible masking and highly efficient activation in human tumor tissue.

Additionally, these data showed potent, consistent and compelling preclinical anti-tumor activity in murine models of human tumor xenografts and excellent prevention of cytokine release in initial non-human primate studies.

Further development of our preclinical INDUKINE and INDUCER programs is dependent upon the outcome of our strategic review process.

Traditional Cancer Therapy, Immunotherapy and the Need for New Treatment Options

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The adaptive immune system is the line of defense that is specific to a pathogen or tumor antigen and is composed of T cells and B cells, which work in concert to kill cells directly, produce antibodies and form immunologic memory.

The latter is critical for the

body’s immune response upon re-exposure to the initial antigen or pathogen.

The latter is critical for the body’s immune response upon re-exposure to the initial antigen or pathogen.

Many of the recent advances in immuno-oncology, such as immune checkpoint inhibitors, have focused on improving the function of T cells.

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Cytokines further increase the proliferation of, enhance the survival of and direct a variety of immune cell types to infiltrate the TME and promote potent antitumor immune responses resulting in tumor cell killing and tumor clearance.

Three cytokine therapies have received U.S.

Food and Drug Administration, or FDA, approval for cancer treatment:

Three cytokine therapies have received FDA approval for cancer treatment:

(1) aldesleukin for the treatment of metastatic renal cell carcinoma, or RCC, and metastatic melanoma;

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They then undergo transformation to an active state upon reaching the TME, thereby delivering the full biological potency of antitumor immune modulation for maximum therapeutic potential.

Our PREDATOR platform is based on protein engineering to combine four critical components into a single INDUKINE molecule, as shown in the figure below.

Our PREDATOR platform is based on protein engineering that in INDUKINE molecules, for example, combines four critical components as shown in the figure below.

• Cytokine Domain :

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Therefore, the identification of a linker substrate with the optimal profile cannot be achieved by biasing the linker sequence towards any single protease or protease family.

To ensure INDUKINE molecules are broadly activated across multiple tumor types, the linker substrate must be efficiently cleaved in the TME of many different tumors while remaining stable in circulation and in normal non-tumor tissues.

To ensure INDUKINE and INDUCER molecules are broadly activated across multiple tumor types, the linker substrate must be efficiently cleaved in the TME of many different tumors while remaining stable in circulation and in normal non-tumor tissues.

We achieve this by utilizing a differentiated approach for linker identification and let the tumors select the substrate, rather than screening for linkers sensitive to cleavage by a single protease.

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Leveraging this screening process, we initially screened several thousand linker sequences for optimal biochemical properties, and then screened the lead sequences for cleavage by a panel of primary human tumor specimens and normal non-tumor tissues.

Linker sequences that were not efficiently cleaved by human tumor samples (for example, the linker shown as Linker 1 in the diagram below) were eliminated in the screening and those that were efficiently cleaved by human tumors but not cleaved by normal serum or tissues (for example, the linker shown as Linker 3 in the diagram below) were selected for incorporation into our INDUKINE molecules to confirm their activity in vitro and in vivo .

We have selected linkers for our INDUKINE molecules with characteristics similar to those of Linker 3 in the table below.

Linker sequences that were not efficiently cleaved by human tumor samples (for example, the linker

shown as Linker 1 in the diagram below) were eliminated in the screening and those that were efficiently cleaved by human tumors but not cleaved by normal serum or tissues (for example, the linker shown as Linker 3 in the diagram below) were selected for incorporation into our INDUKINE molecules to confirm their activity in vitro and in vivo .

We have selected linkers for our INDUKINE and INDUCER molecules with characteristics similar to those of Linker 3 in the table below.

Human Tissue Screening for Selection of Optimized Linker Candidates

We seek to protect aspects of our PREDATOR platform technology by obtaining patent protection in the United States and internationally.

Currently, our patent portfolio for our PREDATOR platform technology includes two families of pending patent applications, which disclose and claim protease cleavable linkers and libraries of protease cleavable linkers, as well as polypeptides that contain such linkers, methods of making libraries and methods of screening libraries to identify linkers with desired properties.

These patent families were recently filed, and no patents have been granted.

Currently, our patent portfolio for our PREDATOR platform technology includes three families of pending patent applications, which disclose and claim protease cleavable linkers and libraries of protease cleavable linkers, as well as polypeptides that contain such linkers, methods of making libraries and methods of screening libraries to identify linkers with desired properties.

For more information see “Intellectual Property” described in this Part I, Item 1.

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Upon reaching the TME, INDUKINE molecules are activated via cleavage of our proprietary linkers by tumor-specific proteases which results in release of the cytokines in the tumor.

We select our linkers to be

specifically cleaved in the tumor and be stable in circulation and normal non-tumor tissues, with the goal enhancing the tolerability profile of our INDUKINE molecules.

We select our linkers to be specifically cleaved in the tumor and be stable in circulation and normal non-tumor tissues, with the goal enhancing the tolerability profile of our INDUKINE molecules.

INDUCER T Cell Engager Molecules

We have used our PREDATOR platform to create INDUCER molecules that use proprietary masking technology and a clinically validated pan-cancer linker to improve the therapeutic index of various T cell engagers.

These INDUCER molecules have the following elements:

• Tumor protease cleavable linkers:

A novel pan-cancer linker acts as a tumor-specific switch, designed to enable precise unmasking in the TME.

• Anti-CD3 mask:

Our proprietary and optimized anti-CD3 masking technology is designed to reduce off-tumor toxicity.

We use a novel anti-CD3 antibody that is optimized for developability

All of our INDUCER molecules utilize a proprietary anti-HSA for half-life extension and increased tumor exposure.

• Tumor antigen binding domain:

Each INDUCER molecule contains a tumor-associated antigen binding domain for optimal immune cell engagement.

• Tumor targeting mask:

We utilize proprietary, optimized targeting masks for tumor targets with extensive expression in normal tissues that is intended to improve exposure.

Our IL-2 INDUKINE Molecule

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We have the opportunity to potentially expand upon the patient populations and indications beyond those for which Proleukin (aldesleukin) is approved.

We intend to develop WTX-124 as monotherapy and in combination with pembrolizumab, and eventually in combination with other standard of care therapeutics across different lines of therapy.

We have developed WTX-124 as a monotherapy and in combination with pembrolizumab, and eventually in combination with other standard of care therapeutics across different lines of therapy.

According to the Checkpoint Inhibitors Global Market Report 2024, the global checkpoint inhibitors market is expected to grow to $55.64 billion in 2028 at a CAGR of 10.1%.

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In June 2024, at the American Society of Clinical Oncology, or ASCO, Annual Meeting, we presented updated interim data from dose escalation, both monotherapy and combination therapy with pembrolizumab, in the Phase 1/1b clinical trial, and announced our recommended dose for expansion, or RDE, of 18 mg for monotherapy, and opening of monotherapy expansion arms.

As of May 1, 2024, 47 patients had been treated with at least one dose of WTX-124, 35 in monotherapy and 12 in combination dose escalation.

The data continued to demonstrate that WTX-124 was generally well-tolerated in the outpatient setting at monotherapy doses up to 28 mg and combination doses up to 12 mg, with no new safety signals in combination with pembrolizumab.

WTX-124 as a monotherapy produced objective clinical responses, including a durable confirmed complete response, or CR, and two partial responses, or PRs, at the active dose levels of 12 and 18 mg.

Both PRs were confirmed subsequent to the data cutoff, and one remained progression-free as of November 7, 2024.

Increased T cell activation signature for the combination suggested a potential for improved efficacy by combining WTX-124 with pembrolizumab.

Of the two previously disclosed PRs in combination therapy, one PR improved to a CR, and both combination responses remain ongoing at greater than eight months.

We have targeted full enrollment in the monotherapy dose expansion arm in the first half of 2025 and in the combination arm in the second half of 2025.

In December 2025, we reported updated interim data from the Phase 1/1b clinical trial for WTX-124 as of October 30, 2025, which included objective, durable responses as a monotherapy in melanoma, cutaneous squamous cell carcinoma, and gastroesophageal junction cancer, and in combination with pembrolizumab in cutaneous melanoma, non-small cell lung cancer, and renal cell carcinoma.

Monotherapy objective response rate of 21% seen in heavily pretreated patients with advanced or metastatic cutaneous melanoma is consistent with historic high-dose IL-2 activity.

There was no evidence of vascular leak syndrome or recurrence of prior immune-related adverse events, and with Grade 3 and 4 related treatment-emergent adverse events seen in 25.5% (27/106) and 1.9% (2/106), based on clinical data as of October 20, 2025.

For patients in this same melanoma population who had a prior response to any immunotherapy regimen (i.e., were not primary resistant to immunotherapy), a 30% objective response rate was observed.

Among patients treated on study with either 12 or 18 mg of WTX-124, tumor regression was seen in approximately 33% of tumors, including renal cell carcinoma, cutaneous squamous cell carcinoma, non-small cell lung cancer, and additional solid tumor indications.

In addition, at a recent End of Phase 1 meeting with the FDA, 18 mg was accepted as the recommended dose to move forward in development, and the FDA provided initial guidance for a monotherapy WTX-124 registration path in post-ICI advanced or metastatic relapsed/refractory melanoma.

The Phase 1/1b clinical trial of WTX-124 is expected to be completed in the second quarter of 2026.

Additional funding will be required to initiate any further development, which could include a registration-enabling trial.

We are currently seeking a strategic partnership for the further development of WTX-124.

The rationale for our clinical development strategy is as follows:

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WTX-330 Clinical Development Plan

We have evaluated WTX-330 in a Phase 1 clinical trial for the treatment of immunotherapy resistant advanced or metastatic solid tumors or lymphoma, followed by expansion arms in relapsed/refractory tumors following treatment with checkpoint inhibitors or tumors for which checkpoint inhibitors are not approved.

In November 2024, at the 39th Annual Meeting of the Society for Immunotherapy Cancer, or SITC, we presented preliminary first-in-human clinical data from the Phase 1 clinical trial of WTX-330.

The preliminary data established proof of mechanism for WTX-330 and proof of concept for our second INDUKINE molecule, and included assessments of safety and tolerability, pharmacokinetics, relevant biomarkers and preliminary antitumor activity.

The preliminary data, collected as of October 7, 2024, was generated from 25 heavily pretreated patients from three dose escalation cohorts (0.016, 0.024, and 0.032 mg/kg) and two expansion arms at 0.024 mg/kg in patients resistant to checkpoint inhibitors or for whom checkpoint inhibitors were not indicated.

WTX-330 was generally well-tolerated, with the most common adverse events expected for IL-12 therapy, including cytokine release syndrome, pyrexia, and liver function test elevations.

WTX-330 delivered 22-fold more IL-12 than rhIL-12 therapy at its maximal tolerated dose.

Anti-tumor activity was noted, including one confirmed PR in metastatic melanoma and stable disease in patients with less immunosensitive tumors.

Biomarker data, including NanoString, showed pleiotropic immune activation in the TME, consistent with the mechanism of action of IL-12.

We expect to initiate a Phase 1/2 dose and regimen-finding clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors.

We evaluated WTX-330 in a first-in-human Phase 1 clinical trial for the treatment of immunotherapy resistant advanced or metastatic solid tumors or lymphoma.

We reported initial data from the Phase 1 clinical trial in June 2024 and presented updated interim safety and efficacy data from the Phase 1 clinical trial at the Society for Immunotherapy of Cancer Annual Meeting in November 2024, highlighting the tolerability profile and monotherapy efficacy signals of WTX-330.

The Phase 1 clinical trial was completed in the first quarter of 2025.

Guided by these data, we initiated a Phase 1b/2 clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors.

In the Phase 1b/2 clinical trial of WTX-330, additional evidence of highly favorable tolerability and antitumor activity in challenging tumor types was observed in the first twelve patients treated as of the data cutoff date of October 31, 2025.

These results build upon data from the first-in-human Phase 1 clinical trial.

An optimized manufacturing process for WTX-330 was introduced in this study, which further improved the safety profile, pharmacokinetics, and therapeutic index.

At a dose of 0.024 mg/kg IV twice weekly, WTX-330 had a 17-fold higher Cmax than the published Cmax of rhIL-12, and at all dose levels, free IL-12 levels were 0.12% of prodrug exposure.

As of December 2, 2025, there was one confirmed partial response in metastatic gall bladder cancer failing prior standard of care with a 45% reduction in tumor target lesions by RECIST 1.1.

Additional funding will be required to further develop WTX-330, which could include sequential administration of WTX-330 and WTX-124 that may provide a novel development path in poorly immunogenic tumors.

We are currently seeking a strategic partnership for the further development of WTX-330.

Our IL-21 INDUKINE Molecule

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WTX-921 is a systemically delivered, conditionally activated IL-10 INDUKINE molecule for the treatment of inflammatory bowel disease and potentially other inflammatory diseases.

We have generated an IND-enabling data package, and WTX-921 is available for partnering opportunities.

Our Early Stage Programs

In addition to IL-2, IL-12, IFNα, IL-21, IL-18, and IL-10 INDUKINE molecules, we are also applying our novel engineering approach to other modalities with a focus on conditionally activated immune cell engagers.

We believe that our PREDATOR platform protein engineering principles can be extended to conditionally activated immune cell engagers, optimizing how immune cell engagers leverage the immune system to fight cancer.

Our goal is to better understand how the localized tumor delivery of immunomodulatory molecules might contribute to disease control while reducing the toxicity that in many cases accompany the systemic delivery of molecules such as cytokines or immune cell engagers.

Our Partnered Programs

IFNα INDUKINE Molecule Licensed Globally to Jazz Pharmaceuticals

In May 2025, we presented preclinical data for WTX-921 at the AAI annual meeting demonstrating the potential of WTX-921 to modulate disease-driving innate and adaptive immune responses.

We have generated an IND-enabling data package, and WTX-921 is available for strategic partnering opportunities.

Our STEAP1 INDUCER Molecule

WTX-1011 is the first of our INDUCER T cell engager development candidates, targeting advanced, relapsed/refractory STEAP1-expressing cancers.

Preclinical data has demonstrated the power of the INDUCER technology with robust silencing, reversible masking and highly efficient activation in human tumor tissue.

Our CDH6 INDUCER Molecule

WTX-2022 is our second, recently announced INDUCER development candidate, targeting the CDH6 tumor associated antigen.

Preclinical data for WTX-2022 has demonstrated consistent results with those of WTX-1011 described above.

Our Partnered Program

IFNα INDUKINE Molecule Licensed Globally to Jazz Pharmaceuticals Ireland Limited

JZP898 (formerly WTX-613) is a systemically delivered, conditionally activated IFNα INDUKINE molecule that we are collaborating with Jazz to develop to minimize the severe toxicities that have been observed with recombinant human IFNα, or rhIFNα, therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors or other standard of care therapy.

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In April 2022, we entered into a global collaboration and license agreement, or the Collaboration Agreement, with Jazz under which Jazz acquired exclusive global development and commercialization rights to WTX-613, which has subsequently been designated JZP898, as well as products containing certain isolated recombinant polypeptides comprising IFNα that meet specified criteria (each such product, a Licensed Product).

Pursuant to the terms of the Collaboration Agreement, we are responsible for certain preclinical development activities with respect to JZP898 and other development activities specified in mutually agreed upon development plans.

Jazz will generally reimburse us for the cost of such activities.

Jazz will be responsible for all other development and commercialization activities conducted to exploit the Licensed Products.

Pursuant to the terms of the Collaboration Agreement, we were responsible for certain preclinical development activities with respect to JZP898 and other development activities specified in mutually agreed upon development plans.

Jazz generally reimbursed us for the cost of such activities.

Jazz is responsible for all other development and commercialization activities conducted to exploit the Licensed Products.

In June 2024, we executed a transfer agreement, or the Transfer Agreement, to assign our rights in a development agreement with a contract manufacturer of our interferon alpha INDUKINE molecule JZP898 to Jazz.

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Proleukin (aldesleukin) has been approved and is marketed for the treatment of both metastatic RCC and metastatic melanoma.

In addition, we are aware of numerous clinical and preclinical IL-2 molecules using different platforms being developed for oncology indications, including programs from Anaveon AG, Anwita Biosciences, Inc., Ascendis Pharma A/S, Asher Biotherapeutics, Inc., Aulos Bioscience, Inc., BioNTech SE, Cue Biopharma, Inc., DEKA Biosciences, Inc., Merck & Co., Inc., Medicenna Therapeutics Corp., Mural Oncology PLC, F.

Hoffmann-La Roche AG, Synthekine, Inc., and Xilio Therapeutics, Inc.

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(Amunix), DEKA Biosciences, Inc., DragonFly Therapeutics, Inc., Juno Therapeutics, Inc.

(Bristol-Myers Squibb Company), Mural Oncology, OncoSec Medical Incorporated, Philogen S.p.A., Sonnet BioTherapeutics, Inc., Turnstone Biologics Corp.

(Bristol-Myers Squibb Company), OncoSec Medical Incorporated, PDS Biotechnology, Philogen S.p.A., Sonnet BioTherapeutics, Inc., Turnstone Biologics Corp.

(partnered with Takeda Pharmaceutical Company Limited), Xilio Therapeutics, Inc., and Zymeworks Inc.

We are developing WTX-124 and WTX-330 as potential monotherapies in relapsed or refractory tumor types or in combination with checkpoint inhibitors or other standard of care therapies in advanced or metastatic malignancies with high unmet medical need.

Standard of care therapies include chemotherapy, targeted therapy, and more recently, immunotherapies, including

monoclonal antibodies and bispecific formats, antibody drug conjugates, adoptive cellular therapies, and cytokines.

Standard of care therapies include chemotherapy, targeted therapy, and more recently, immunotherapies, including monoclonal antibodies and bispecific formats, antibody drug conjugates, adoptive cellular therapies, and cytokines.

In addition, there are numerous investigational agents in clinical development.

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Our third-party manufacturers will also be subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.

In March 2024, we received alignment from the U.S.

Food and Drug Administration, or the FDA, on the comparability path for WTX-330 for an improved manufacturing process.

Commercialization Plan

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We also rely on trade secrets and proprietary know-how to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

Our patent portfolio includes patents and patent applications with composition of matter and method of use claims with respect to our product candidates, WTX-124, WTX-330, JZP898, WTX-712, WTX-518, and WTX-921, and claims directed to our PREDATOR platform technology.

Our patent portfolio includes patents and patent applications with composition of matter and method of use claims with respect to our product candidates, WTX-124, WTX-330, JZP898, WTX-712, WTX-518, WTX-921, WTX-1011, and WTX-2022, and claims directed to our PREDATOR platform technology.

For our product candidates, we will, in general, initially pursue patent protection covering compositions of matter and methods of use.

Throughout the development of our product candidates, we will seek to identify

additional opportunities for obtaining patent protection that would potentially enhance commercial success, including through additional methods of use, processes for manufacture, formulation and dosing regimen-related claims.

Throughout the development of our product candidates, we will seek to identify additional opportunities for obtaining patent protection that would potentially enhance commercial success, including through additional methods of use, processes for manufacture, formulation and dosing regimen-related claims.

Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our current and future product candidates, platform technologies, novel discoveries, product development technologies and know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights.

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Regardless of the coverage we seek under our existing patent applications, there is always a risk that an alteration to the product or process may provide sufficient basis for a competitor to avoid infringement claims.

In addition, the coverage claimed in a

patent application can be significantly reduced before a patent is issued, and courts can reinterpret patent scope after issuance.

In addition, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and courts can reinterpret patent scope after issuance.

Moreover, many jurisdictions, including the United States, permit third parties to challenge allowed or issued patents in administrative proceedings, which may result in further narrowing or even cancellation of patent claims.

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The status of our patent portfolio changes frequently in the ordinary course of patent prosecution.

As of February 5, 2025, our patent portfolio included approximately eight (8) issued patents in the United States, approximately forty (40) pending U.S.

provisional or non-provisional patent applications, eight (8) pending international patent applications filed under the PCT and approximately one hundred nine (109) pending foreign patent applications, including pending applications in Australia, Brazil, Canada, China, European Patent Office, Hong Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore, South Africa and Taiwan.

As of March 26, 2026, our patent portfolio included approximately eleven (11) issued patents in the United States, approximately twenty-nine (29) pending U.S.

provisional or non-provisional patent applications, nine (9) pending international patent applications filed under the PCT and approximately one hundred twenty (120) pending foreign patent applications, including pending applications in Australia, Brazil, Canada, China, European Patent Office, Hong Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore, South Africa and Taiwan.

These patent applications, if issued, are expected to expire on various dates from 2039 through about 2046, in each case without taking into account any possible patent term extension that may be available.

Our patent portfolio on our PREDATOR platform technology includes three patent families directed to protease cleavable linkers and libraries of protease cleavable linkers, as well as polypeptides that contain such linkers and methods of making libraries and screening libraries to identify linkers with desired properties.

One of the patent families includes one issued U.S.

patent with claims directed to protease cleavable linkers, and pending applications in the United States, Australia, Brazil, Canada, China, European Patent Office, Hong Kong, Israel, India, Japan, Republic of Korea, Mexico and Singapore.

One of the patent families includes patents issued in the U.S., Australia, and Japan with claims directed to protease cleavable linkers, and pending applications in the United States, Australia, Brazil, Canada, China, European Patent Office, Hong Kong, Israel, India, Japan, Republic of Korea, Mexico and Singapore.

The 20-year term for patents in this family runs through 2040, excluding any extension of patent term that may be available.

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The third patent family currently consists of a pending U.S.

provisional application.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

Our platform technology patent portfolio also includes a patent family directed to conditionally activated immune cell engagers.

The patent family currently consists of a pending U.S.

provisional application.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

non-provisional application.

The 20-year term for patents in this family runs through 2046.

Our patent portfolio also includes patent and patent applications that we license from Harpoon Therapeutics, Inc., or Harpoon.

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One of the families includes patents issued in the U.S.

(four patents), Australia, Europe, Hong Kong, Japan, and Russian Federation with certain composition of matter claims with respect to IL-2 INDUKINE molecules and WTX-124.

We have also filed pending U.S.

(five patents), Australia (two patents), Europe, Hong Kong, Japan, Mexico, and Russian Federation with certain composition of matter claims with respect to IL-2 INDUKINE molecules and WTX-124.

filed pending U.S.

applications and pending foreign patent applications in Australia, Brazil, Canada, China, European Patent Office, Hong Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore and South Africa that claim certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and WTX-124.

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A second patent family currently includes patents issued in the U.S.

(two patents), and pending applications in U.S., Australia, Brazil, Canada, China, European Patent Office, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore and South Africa with claims direct to certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and WTX-124.

(two patents), and pending applications in U.S., Australia, Brazil, Canada, China, European Patent Office, Hong-Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore and South Africa with claims direct to certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and WTX-124.

These applications also claim certain compositions of matter and method of use with respect to INF-a INDUKINE molecules and WTX-613.

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that claim certain methods of use with respect our IL-2 INDUKINE molecules and our WTX-124 product candidate.

This family also claims certain methods of use with respect to IL-12 INDUKINE molecules and our WTX-330 product candidate, and INF-a INDUKINE molecules and WTX-613.The 20-year term for patents in this family will run through to 2042, excluding any extension of patent term that may be available.

A fifth patent family includes a pending U.S.

provisional application that claims certain compositions of matter and method of use with respect to IL-2 INDUKINE molecules and our WTX-124 product candidate.

The 20-year term for patents in this family will run

through 2045, excluding any extension of patent term that may be available.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

A sixth patent family includes a pending U.S.

provisional application that claims certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and our WTX-124 product candidate.

This family also claims certain compositions of matter and methods of use with respect to IL-12 INDUKINE molecules and our WTX-330 product candidate, and INF-a INDUKINE molecules and WTX-613.

This family also claims certain methods of use with respect to IL-12 INDUKINE molecules and our WTX-330 product candidate, and INF-a INDUKINE molecules and WTX-613.

The 20-year term for patents in this family will run through to 2042, excluding any extension of patent term that may be available.

A sixth patent family includes a pending PCT application that claims certain compositions of matter and method of use with respect to IL-2 INDUKINE molecules and our WTX-124 product candidate.

The 20-year term for patents in this family will run through 2045, excluding any extension of patent term that may be available.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

We intend to file national applications in other jurisdictions based on the pending PCT application before the applicable deadline.

Our seventh patent family includes a pending U.S.

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One of the families includes patents issued in the U.S.

(two patents), Australia, Japan, and Russian Federation with certain composition of matter claims with respect to IL-12 INDUKINE molecules.

(three patents), Australia (two patents), Japan, Mexico, and Russian Federation with certain composition of matter claims with respect to IL-12 INDUKINE molecules.

We have also filed a pending U.S.

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The 20-year term for patents in this family will run through to 2042, excluding any extension of patent term that may be available.

A fifth patent family includes a pending PCT application that claims certain methods of use of our IL-12 INDUKINE molecules and WTX-330 product candidate.

We intend to file national applications in other jurisdictions based on the PCT application before the applicable deadlines.

A fifth patent family includes pending applications in the U.S., Canada, European Patent Office, and Japan that claim certain methods of use of our IL-12 INDUKINE molecules and WTX-330 product candidate.

The 20-year term for patents in this family will run through 2044, excluding any extension of patent term that may be available.

A sixth patent family includes a pending U.S.

provisional application that claims certain methods of use of our IL-12 INDUKINE molecules and WTX-330 product candidate.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

A sixth patent family includes a pending PCT application that claims certain methods of use of our IL-12 INDUKINE molecules and WTX-330 product candidate.

We intend to file national applications in other jurisdictions based on the PCT application before the applicable deadlines.

The 20-year term for patents in this family will run through 2045, excluding any extension of patent term that may be available.

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provisional application that claims certain compositions of matter and methods of use with respect to IL-12 INDUKINE molecules and our WTX-330 product candidate.

This family also claims certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and our WTX-124 product candidate, and INF-a INDUKINE molecules and WTX-613.

The 20-year term for patents in this family will run through 2045, excluding any extension of patent term that may be available.

This family also claims certain compositions of matter and methods of use with respect to IL-2 INDUKINE molecules and our WTX-124 product candidate.

The 20-year term for patents in this family

will run through 2046, excluding any extension of patent term that may be available.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

We own five patent families directed to our INF-a INDUKINE molecules and our WTX-613 product candidate.

We own a first patent family that includes pending foreign applications in the United States, Australia, Brazil, Canada, China, European Patent Office, Hong Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore and South Africa that claim certain compositions of matter and methods of use with respect to INF-a INDUKINE molecules and WTX-613.

We own a first patent family that includes pending applications in the United States, Australia, Brazil, Canada, China, European Patent Office, Hong Kong, India, Israel, Japan, Republic of Korea, Mexico, Russian Federation, Singapore and South Africa that claim certain compositions of matter and methods of use with respect to INF-a INDUKINE molecules and WTX-613.

The 20-year term for patents in this family runs through 2039, excluding any extension of patent term that may be available.

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The 20-year term for patents in this family runs through 2040, excluding any extension of patent term that may be available.

We filed a pending application in the United States that combined the disclosures of the first and second families and claims compositions of matter and certain methods of use with respect to

We filed a pending application in the United States that combined the disclosures of the first and second families and claims compositions of matter and certain methods of use with respect to WTX-613.

The 20-year term for patents based on the pending U.S.

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The 20-year term for patents in this family will run through to 2042, excluding any extension of patent term that may be available.

Our fifth patent family currently consists of a pending PCT application directed to certain methods of use with respect to WTX-613.

The 20-year term for patents in this family will run through 2045, excluding any extension of patent term that may be available.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

We own a patent family directed to our IL-21 INDUKINE molecules and our WTX-712 product candidate.

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The 20-year term for patents in this family runs through 2044.

We own two patent families directed to our IL-10 INDUKINE molecules and our WTX-921 product candidate.

We own a first patent family that includes a pending PCT application that claims certain compositions of matter and method of use with respect to IL-10 INDUKINE molecules and WTX-921.

We intend to file national applications in other jurisdictions based in the pending PCT application before applicable deadlines.

We own one patent family directed to our IL-10 INDUKINE molecules and our WTX-921 product candidate.

The patent family includes pending applications in the United States, Australia, Canada, China, European Patent Office, and Japan with claims directed to certain compositions of matter and method of use with respect to IL-10 INDUKINE molecules and WTX-921.

The 20-year term for patents in this family runs through 2044.

Our second patent family includes a pending U.S.

provisional application directed to certain compositions of matter and method of use with respect to IL-10 INDUKINE molecules and WTX-921.

The 20-year term for patents in this family will run through 2045, excluding any extension of patent term that may be available.

We plan to file an international patent application under the PCT based on this provisional application before the applicable deadlines.

WTX-1011 and WTX-2022

We own four patent families directed to our INDUCER T-cell engagers, our WTX-1011 product candidate and our WTX-2022 product candidate.

One of the patent families includes a pending PCT application that claims certain compositions of matter and method of use with respect to INDUCER T-cell engagers.

We intend to file national applications in other jurisdictions based on the pending PCT application before the applicable deadline.

The 20-year term for patents in this family runs through 2045, excluding any extension of patent term that may be available.

The second family consists of a pending U.S.

provisional application.

We plan to file an international application under the PCT based on this provisional before the applicable deadline.

The 20-year term for patents in this family runs through 2046.

The third family currently consists of a pending U.S.

provisional application that claims certain compositions of matter and methods of use with respect to INDUCER T-cell engagers and our WTX-1011 product candidate.

We plan to file an international application under the PCT based on this provisional before the applicable deadline.

The 20-year term for patents in this family runs through 2046.

The fourth family currently consists of

provisional application that claims certain compositions of matter and methods of use with respect to INDUCER T-cell engagers and our WTX-2022 product candidate.

We plan to file an international application under the PCT based on this provisional before the applicable deadline.

The 20-year term for patents in this family runs through 2046.

In-Licensed Patents

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The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, permits a patent term extension of up to five years beyond the expiration date set for the patent.

Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to each regulatory review period may be granted an

extension and only those claims reading on the approved drug are extended.

Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug.

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Under the Harpoon Agreement, we agreed to pay to Harpoon an upfront fee of $0.5 million and, if we commercialize any products covered by these licensed patents, a low single digit percentage royalty on net sales of such products by us or any of our affiliates or licensees, subject to an obligation to make a minimum annual royalty payment at an amount in the low hundreds of thousands of dollars beginning with the first commercial sale of any such product by us.

In October 2018, we and Harpoon amended the Harpoon Agreement by entering into a First Amended and Restated Assignment and License Agreement, which amended certain terms of the original agreement, but did not change the terms of the license to us, patent assignments between the parties or payments due to Harpoon.

In December 2019, we and Harpoon amended the Harpoon Agreement by entering into a Second Amended and Restated Assignment and License Agreement, or the Second Amended Harpoon Agreement, which granted to us an additional worldwide, exclusive, irrevocable, royalty-bearing, transferable, assignable, sublicensable license under certain patents owned by Harpoon and related to certain proteins, to make, have made, use, sell, offer for sale and import products that are covered by such patents in the field of molecules comprising a certain protein.

In October 2018, we and Harpoon amended the Harpoon Agreement by entering into a First Amended and Restated Assignment and License Agreement, or the First Amended and Restated Harpoon Agreement, which amended certain terms of the original agreement, but did not change the terms of the license to us, patent assignments between the parties or payments due to Harpoon.

In December 2019, we and Harpoon amended the First Amended and Restated Harpoon Agreement by entering into a Second Amended and Restated Assignment and License Agreement, or the Second Amended Harpoon Agreement, which granted to us an additional worldwide, exclusive, irrevocable, royalty-bearing, transferable, assignable, sublicensable license under certain patents owned by Harpoon and related to certain proteins, to make, have made, use, sell, offer for sale and import products that are covered by such patents in the field of molecules comprising a certain protein.

Under the Second Amended Harpoon Agreement, we agreed to pay to Harpoon a low single digit percentage royalty on net sales by us or any of our affiliates or licensees of any products that we commercialize covered by these additional licensed patents.

In addition, we also agreed to grant to Harpoon, and Harpoon agreed to grant to us, a perpetual, non-exclusive, irrevocable, royalty-free license under certain other patents directed

to a certain binding domain of a certain protein, to make, have made, use, sell, offer for sale and import products that are covered by such patents in a field defined by a certain type of molecule with respect to each party.

In addition, we also agreed to grant to Harpoon, and Harpoon agreed to grant to us, a perpetual, non-exclusive, irrevocable, royalty-free license under certain other patents directed to a certain binding domain of a certain protein, to make, have made, use, sell, offer for sale and import products that are covered by such patents in a field defined by a certain type of molecule with respect to each party.

Unless earlier terminated, our obligations to pay any royalties under the Second Amended Harpoon Agreement will expire on a country-by-country basis upon expiration of the last to expire valid claim of the relevant patents covering the manufacture, use or sale of such covered products in the applicable country.

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Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union, or EU, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, sales, pricing, reimbursement, post-approval monitoring and reporting, and import and export of pharmaceutical products.

The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along

with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

The regulatory requirements applicable to product development, approval and marketing are subject to change, and regulations and administrative guidance often are revised or reinterpreted by the agencies in ways that may have a significant impact on our business.

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The FDA requires a 30-day waiting period after the filing of each IND before clinical trials may begin.

This waiting period is designed to allow the FDA to review the IND to determine whether human research subjects and patients will be exposed to unreasonable health risks and to address any other issues, including chemistry, manufacturing and controls, or CMC, for the proposed product.

This waiting period is designed to allow the FDA to review the IND to determine whether human research subjects and patients will be exposed to unreasonable health risks and to address any other

issues, including chemistry, manufacturing and controls, or CMC, for the proposed product.

At any time during this 30-day period, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold.

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This group provides authorization for whether a trial may move forward at designated check points based on access that only the group maintains to available data from the trial.

Suspension or termination of

development during any phase of clinical trials can occur if it is determined that the participants or patients are being exposed to an unacceptable health risk or for other reasons.

Suspension or termination of development during any phase of clinical trials can occur if it is determined that the participants or patients are being exposed to an unacceptable health risk or for other reasons.

Human Clinical Studies in Support of an NDA or BLA

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A clinical trial may combine the elements of more than one phase and the FDA often requires more than one Phase 3 trial to support marketing approval of a product candidate.

A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA.

A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that phase because this

determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA.

Generally, pivotal trials are Phase 3 trials, but they may be Phase 2 trials if the design provides a well-controlled and reliable assessment of clinical benefit, particularly in an area of unmet medical need.

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Under federal law, the fee required for the submission and review of an application under the Prescription Drug User Fee Act, or the PDUFA, is substantial (for example, for federal fiscal year 2025 this application fee is approximately $4.3 million), and the sponsor of an approved application is also subject to an annual program fee, currently more than $403,889 per eligible prescription product for federal fiscal year 2025.

Certain exceptions and waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver for certain small businesses.

Certain exceptions and

waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver for certain small businesses.

If an application is withdrawn prior to the FDA acceptance for filing, 75% of these fees may be refunded to the sponsor.

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These pre-approval inspections may cover all facilities associated with an NDA or BLA submission, including drug component manufacturing (e.g., active pharmaceutical ingredients), finished drug product manufacturing, and control testing laboratories.

The FDA will not approve an application unless it determines that the manufacturing processes and

facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

Moreover, the FDA will review a sponsor’s financial relationship with the principal investigators who conducted the clinical trials in support of the BLA or NDA.

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If the FDA decides not to license or approve the application, it will issue a CRL.

A CRL will describe all of the deficiencies that the FDA has identified in the application, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling.

A CRL will describe all of the deficiencies that the FDA has identified in the application, except that where the FDA determines that the data supporting the application are

inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling.

In issuing the CRL, the FDA may recommend actions that the applicant might take to place the application in condition for approval, including requests for additional information or clarification.

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Specifically, the FDA may designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.

For Fast Track products, sponsors may have greater interactions

with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete.

For Fast Track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete.

This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective.

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The FDA may grant accelerated approval to a product for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, or IMM, and 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.

The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on

irreversible morbidity or mortality, or IMM, and 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.

Products granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

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In November 2013, the federal Drug Supply Chain Security Act became effective in the United States, mandating an industry-wide, electronic, interoperable system to trace prescription drugs through the pharmaceutical distribution supply chain with a ten-year phase-in process.

Manufacturers were required by November 2023 to have such systems and processes in place but in August 2023, the FDA set a one-year period in which it would exercise its enforcement discretion with respect to

these requirements.

So as not to disrupt supply chains, the FDA has granted certain exemptions from enhanced drug distribution security requirements for eligible trading partners for particular periods of time.

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ANDAs are “abbreviated” because they generally do not include preclinical and clinical data to demonstrate safety and effectiveness.

Instead, in support of such applications, a generic manufacturer may rely

on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug, or RLD.

Instead, in support of such applications, a generic manufacturer may rely on the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference-listed drug, or RLD.

Under the Hatch-Waxman Amendments, the FDA may not approve an ANDA or 505(b)(2) application until any applicable period of non-patent exclusivity for the RLD has expired.

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Patent Term Restoration and Extension

A patent claiming a new drug product may be eligible for a limited patent term extension under the Hatch-Waxman Amendments, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review.

FDA regulatory review.

The restoration period granted on a patent covering a product is typically one-half the time between the effective date of the IND approval and the submission date of an application, plus the time between the submission date of an application and the ultimate approval date.

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A decision by a third-party payor not to cover a product candidate could reduce physician utilization once the product is approved and have a material adverse effect on sales, results of operations and financial condition.

Additionally, a payor’s decision to provide coverage for a product does not imply that an

adequate reimbursement rate will be approved.

Additionally, a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved.

Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage and reimbursement for the product, and the level of coverage and reimbursement can differ significantly from payor to payor.

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In addition, other legislative changes have been proposed and adopted since the ACA was enacted.

The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

These laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

The Consolidated Appropriations Act, which was signed into law by President Biden in December 2022, made several changes to sequestration of the Medicare program.

Section 1001 of the Consolidated Appropriations Act delays the 4% Statutory Pay-As-You-Go Act of 2010 sequester for two years, through the end of calendar year 2024.

Triggered by enactment of the American Rescue Plan Act of 2021, the 4% cut to the Medicare program would have taken effect in January 2023.

The Consolidated Appropriations Act’s health care offset title includes Section 4163, which extends the 2% Budget Control Act of 2011 Medicare sequester for six months into fiscal year 2032 and lowers the payment reduction percentages in fiscal years 2030 and 2031.

The ACA has been subject to litigation challenging its provisions, and such litigation is likely to continue with uncertain results.

In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress including aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through the first eleven months of the President’s fiscal year 2032 sequestration order unless additional congressional action is taken, with the exception of a temporary suspension, and later a temporary reduction instituted during the COVID-19 pandemic that expired on July 1, 2022.

Since enactment of the ACA, there have been, and continue to be, numerous legal challenges and Congressional actions to repeal and replace provisions of the law.

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On June 17, 2021, the U.S.

Supreme Court dismissed a judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Thus, the ACA will remain in effect in its current form.

The nature and scope of health care reform in the second Trump administration remains uncertain but early actions suggest that efforts to undermine the ACA will be renewed and litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results.

Supreme Court dismissed a judicial

challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Litigation and legislation over the ACA may continue, with unpredictable and uncertain results.

Pharmaceutical Price Reform

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congressional inquiries, as well as proposed and enacted state and federal legislation designed to, among other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs, and reduce the costs of pharmaceuticals under Medicare and Medicaid.

In addition, in October 2020, HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program to import certain prescription drugs from Canada into the United States.

That regulation was challenged in a lawsuit by the Pharmaceutical Research and Manufacturers of America, or PhRMA, but the case was dismissed by a federal district court in February 2023 after the court found that PhRMA did not have standing to sue HHS.

Seven states (Colorado, Florida, Maine, New Hampshire, New Mexico, Texas and Vermont) have passed laws allowing for the importation of products from Canada.

North Dakota and Virginia have passed legislation establishing workgroups to examine the impact of a state importation program.

As of May 2024, five states (Colorado, Florida, Maine, New Hampshire and New Mexico) had

submitted Section 804 Importation Program proposals to the FDA.

On January 5, 2023, the FDA approved Florida’s plan for Canadian product importation.

That state now has authority to import certain products from Canada for a period of two years once certain conditions are met.

Florida will first need to submit a pre-import request for each product selected for importation, which must be approved by the FDA.

The state will also need to relabel the products and perform quality testing of the products to meet FDA standards.

Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026.

The Inflation Reduction Act of 2022, or IRA, further delayed implementation of this rule to January 1, 2032.

On August 16, 2022, the IRA was signed into law by President Biden.

The new legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B to give them the option of paying a monthly premium for outpatient prescription drug coverage.

Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

For example, in August 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law by President Biden.

The legislation requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replaces the Part D coverage gap discount program with a new discounting program.

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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CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 Medicare Part D drugs in 2027, 15 Medicare Part B or Medicare Part D drugs in 2028, and 20 Medicare Part B or Medicare Part D drugs in 2029 and beyond.

This provision applies to drug products that have been approved for at least nine years and biologics that have been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare disease or condition.

This provision applies to drug products that have been approved for at least nine years and biologics that have been licensed for 13 years.

When originally enacted, the IRA explicitly excluded from price negotiation orphan drugs designated for only one rare disease or condition and for which the only active approved indication is for such disease or condition.

However, the One Big Beautiful Bill Act signed into law on July 4, 2025 amended the applicable statute to broaden the orphan drug exclusion to include products with more than one orphan designation and more than one approved indication.

Further, the legislation subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law.

The law also capped Medicare beneficiary out-of-pocket drug costs at $4,000 per year in 2024 and $2,000 a year from 2025 onward.

The first cycle of negotiations for the Medicare Drug Price Negotiation Program commenced in the summer of 2023.

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The prices of these ten drugs will become effective January 1, 2026.

On January 17, 2025, CMS announced its selection of 15 additional drugs covered by Part D for the second cycle of negotiations.

CMS issued a public statement on January 29, 2025, declaring that lowering the cost of prescription drugs is a top priority of the new administration and CMS is committed to considering opportunities to bring greater transparency in the negotiation program.

The second cycle of negotiations with participating drug companies will occur during 2025, and any negotiated prices for this second set of drugs will be effective starting January 1, 2027.

In addition to the drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D.

These programs require manufacturers to pay rebates to Medicare if they raise their prices for certain Part B and Part D drugs faster than the rate of inflation.

On December 9, 2024, with issuance of its 2025 Physician Fee Schedule final regulation, CMS finalized its rules governing the IRA inflation rebate programs.

The new law also caps Medicare out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

On June 6, 2023, Merck & Co.

filed a lawsuit against the HHS and CMS asserting that, among other things, the IRA’s Drug Price Negotiation Program for Medicare constitutes an uncompensated taking in violation of the Fifth Amendment of the Constitution.

Subsequently, a number of other parties, including the U.S.

Chamber of Commerce, Bristol Myers Squibb Company, the PhRMA, Astellas, Novo Nordisk, Janssen Pharmaceuticals, Novartis, AstraZeneca and Boehringer Ingelheim, also filed lawsuits in various courts with similar constitutional claims against the HHS and CMS.

HHS has generally won the substantive disputes in these cases, and various federal district court judges have expressed skepticism regarding the merits of the legal arguments being pursued by the pharmaceutical industry.

Certain of these cases are now on appeal and, on October 30, 2024, the Court of Appeals for the Third Circuit heard oral argument in three of these cases.

We expect that litigation involving these and other provisions of the IRA will continue, with unpredictable and uncertain results.

At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological 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.

On January 17, 2025, CMS announced its selection of 15 additional drugs covered by Part D for the second cycle of negotiations and on November 25, 2025, CMS released negotiated prices for these fifteen additional drugs that will go into effect beginning on January 1, 2027.

While it remains to be seen how the drug pricing provisions imposed by the IRA will affect the broader pharmaceutical industry, several pharmaceutical manufacturers and other industry stakeholders have challenged the law, including through lawsuits brought against the HHS, the Secretary of the HHS, CMS, and the CMS Administrator challenging the constitutionality and administrative implementation of the IRA’s drug price negotiation provisions.

This litigation is ongoing and the results, and potential impacts on our business, are uncertain.

The current presidential administration has indicated that reducing prescription drug prices will be a focus, with CMS issuing a public statement on January 29, 2025, declaring that lowering the cost of prescription drugs is a top priority of the Trump administration and that CMS is committed to considering opportunities to bring greater pricing transparency.

Moreover, President Trump has signed multiple executive orders addressing prescription drug pricing and access, including:

on April 15, 2025, outlining several actions the Secretary of the Department of HHS must take to optimize healthcare regulations that will provide access to prescription drugs at lower costs;

on May 5, 2025, aiming to promote domestic production of critical medicines;

and on May 12, 2025, aiming to establish a “most-favored-nation” drug pricing policy that would tie U.S.

drug prices to the prices paid for drugs in other countries.

Since the May 12, 2025 “most-favored-nation” executive order, the Trump administration has continued to exert pressure on drug manufacturers to implement “most-favored-nation” pricing, including by suggesting that the administration may impose significant tariffs on pharmaceuticals if such manufacturers do not reach agreements to implement “most-favored-nation” pricing.

Additionally, in November 2025, CMS announced a new voluntary payment initiative called the GENEROUS Model (GENErating cost Reductions for U.S.

Medicaid Model) where drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs that are intended to provide such Medicaid programs with a “most-favored-nation” price for participating manufacturers’ products.

Most recently, on December 21, 2025, CMS released proposed rules that, if finalized, would introduce two new mandatory payment models, the Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S.

Medicare Against Rising Drug Costs (GUARD) models, where manufacturers of certain Medicare Part B and Medicare Part D drugs would be assessed rebates if the prices for

such products exceed those paid in economically comparable countries.

It remains to be seen how these drug pricing initiatives will affect the broader pharmaceutical industry.

At the state level, legislatures are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological 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.

A number of states, for example, require drug manufacturers and other entities in the drug supply chain, including health carriers, pharmacy benefit managers, wholesale distributors, to disclose information about pricing of pharmaceuticals.

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These provisions may apply to some of our business activities.

In addition to California, at least eighteen other states have passed comprehensive privacy laws similar to the CCPA and CPRA.

In addition to California, several other states have passed comprehensive privacy laws similar to the CCPA and CPRA.

These laws are either in effect or will go into effect sometime before the end of 2026.

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Some of the provisions of these laws may apply to our business activities.

There are also states that are strongly considering or have already passed comprehensive privacy laws during the 2024 legislative sessions that will go into effect in 2025 and beyond.

Other states will be considering similar laws in the future, and Congress has also been debating passing a federal privacy law.

There are also states that are specifically regulating health information that may affect our business.

For example, the State of Washington passed the My Health My Data Act in 2023 which specifically regulated health information that is not otherwise regulated by the HIPAA rules, and the law also has a private right of action, which further increases the relevant compliance risk.

Connecticut and Nevada have also passed similar laws regulating consumer health data, and more states are considering such legislation in 2024.

These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

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As of December 31, 2025, we had 39 full-time employees, including a total of 15 employees with M.D.

Of these full-time employees, 33 employees are engaged in research and development.

Of these full-time employees, 27 were engaged in research and development.

In February 2026, we implemented a reduction in force, affecting approximately 64% of our workforce as part of a restructuring plan intended to better align our resources with our pursuit of strategic alternatives.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

We consider our relationship with our employees to be good.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees.

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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