Werewolf Therapeutics, Inc. (HOWL): Business Model Canvas [Dec-2025 Updated]

You're looking to cut through the biotech hype and see the real engine behind Werewolf Therapeutics, Inc. (HOWL), and honestly, the Q3 2025 snapshot is stark: they are deep in the R&D phase, burning $11.6 million that quarter with $0 in collaboration revenue, though they still hold $65.7 million in cash as of September 30, 2025. Their entire bet is on the PREDATOR platform, promising conditionally activated therapies that boost efficacy while cutting down on systemic toxicity for tough cancers-a massive value proposition if they can execute on WTX-124 and WTX-330. So, if you want to see the precise structure supporting this high-risk, high-reward play, check out the full Business Model Canvas breakdown we put together for you below.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Key Partnerships

Werewolf Therapeutics, Inc. is actively structuring its external relationships to advance its INDUKINE™ and INDUCER™ pipeline assets, focusing on clinical execution, regulatory navigation, and future commercialization potential.

Clinical research organizations (CROs) for trial execution

Execution of the ongoing clinical programs relies on established networks, though specific CRO financial terms aren't public. The company is focused on maintaining enrollment momentum across its active trials.

The recommended dosing regimen for the lead asset, WTX-124, in its Phase 1/1b trial expansion arms is set at 18 mg administered intravenously every two weeks (IV Q2W). Enrollment across all WTX-124 arms is projected to complete by the first quarter of 2026. For WTX-330, the company anticipated determination of the dosing regimen by the end of 2025.

Academic institutions for research and combination studies

The clinical strategy for WTX-124 involves testing the asset both as a single agent and in combination with third-party checkpoint inhibitors, specifically mentioning pembrolizumab. The company is also advancing its preclinical portfolio, which includes candidates like WTX-712 (IL-21 INDUKINE), WTX-518 (IL-18 INDUKINE), and WTX-921 (IL-10 INDUKINE).

Werewolf Therapeutics planned to complete preclinical work and seek strategic partnerships for these preclinical programs during 2025.

Pharmaceutical companies for future licensing or co-development deals

The business model explicitly anticipates securing external funding through collaboration agreements, strategic alliances, and licensing arrangements to finance future operations beyond the current cash runway. However, current reported revenue from this segment shows a gap.

Collaboration revenue for the first quarter of 2025 was reported as $0, a decrease from $742,000 reported in the first quarter of 2024. The company is actively positioning its preclinical assets for potential deals.

• Preclinical development candidates available for partnering include:
• WTX-712 (Interleukin-21 INDUKINE) for cancer
• WTX-518 (binding protein resistant Interleukin-18 INDUKINE) for cancer
• WTX-921 (Interleukin-10 INDUKINE) for inflammatory bowel disease (IBD) and other inflammatory diseases

US Food and Drug Administration (FDA) for regulatory pathway guidance

Engagement with the FDA is a critical near-term milestone for the lead candidate, WTX-124. The company is focused on data readouts to inform these regulatory discussions.

Werewolf Therapeutics expected to engage with regulatory authorities in the second half of 2025 to discuss potential registrational pathways for WTX-124 in advanced or metastatic cutaneous melanoma. This was further supported by an anticipated End of Phase 1 meeting feedback in the fourth quarter of 2025.

A significant regulatory event occurred on October 8, 2025, when the FDA granted Fast Track Designation to WTX-124 for treating patients with locally advanced or metastatic cutaneous melanoma following standard of care immunotherapy.

The company's cash and cash equivalents as of September 30, 2025, stood at $65.7 million, which was projected to fund operations into the fourth quarter of 2026.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Key Activities

The Key Activities for Werewolf Therapeutics, Inc. center on the discovery, development, and clinical validation of its conditionally activated therapeutics, primarily driven by the proprietary PREDATOR^® platform.

Research and development (R&D) of the PREDATOR platform

The core activity involves the continuous advancement of the PREDATOR platform, which uses clinically validated protease-cleavable linkers for tumor-selective activation to improve the therapeutic index. This R&D effort supports both the INDUKINE™ and INDUCER™ programs. Research and development expenses for the third quarter ended September 30, 2025, were $11.6 million. This contrasts with the $12.5 million reported for the same period in 2024. The company also plans to nominate a differentiated target candidate for its INDUCER T-cell engager program by year-end 2025.

Key R&D focus areas include:

• Advancing the proprietary PREDATOR^® platform technology.
• Developing the INDUCER™ T-cell engager molecules.
• Completing preclinical work to support IND-stage programs.

Execution of Phase 1/1b clinical trials for WTX-124 and WTX-330

Execution involves running and analyzing data from ongoing clinical trials for the lead INDUKINE molecules. For WTX-124, all expansion arms in the ongoing Phase 1/1b clinical trial are actively enrolling patients at the recommended dose of 18 mg administered intravenously every two weeks (IV Q2W). Interim data from the monotherapy and combination expansion arms are expected to be released in the fourth quarter of 2025. For WTX-330, which is in a Phase 1b/2 clinical trial (WTX-330x2102), the determination of the dosing regimen is anticipated by the end of 2025. The company also planned to meet with the U.S. Food & Drug Administration (FDA) in the second half of 2025 to discuss potential registrational pathways for WTX-124.

Here's a look at the financial and trial status as of late 2025:

Manufacturing of INDUKINE™ and INDUCER™ drug candidates

While specific manufacturing costs aren't itemized separately from R&D, the activity is implied by the progression of clinical candidates into and through Phase 1/1b and Phase 1b/2 trials, which necessitates GMP (Good Manufacturing Practice) material production. The company is advancing its lead INDUKINE™ assets, WTX-124 and WTX-330. Furthermore, Werewolf Therapeutics is developing its first INDUCER™ T-cell engager development candidate, WTX-1011, which targets STEAP1. Progress on WTX-1011 includes being in IND-enabling studies as of Q3 2025.

Manufacturing supports the following pipeline assets:

• WTX-124 (IL-2 INDUKINE) in Phase 1/1b trial.
• WTX-330 (IL-12 INDUKINE) in Phase 1b/2 trial.
• WTX-1011 (STEAP1 INDUCER) in IND-enabling studies.

Securing intellectual property (IP) and patent protection

Securing IP is a foundational activity, underpinning the proprietary nature of the PREDATOR platform and its resulting molecules. The company's ability to defend its IP is a noted risk factor in its filings. The proprietary nature of the PREDATOR platform itself is a key asset. The company is actively working to nominate a differentiated target candidate for its INDUCER T-cell engager program by the end of 2025, which involves securing the necessary IP around that novel target. Additionally, WTX-124 has received Fast Track Designation from the US FDA, which is a regulatory, but often IP-related, strategic advantage for potential accelerated approval pathways.

Key IP-related milestones planned for late 2025 include:

• Nomination of a differentiated INDUCER target candidate.
• Discussions with the FDA on registrational pathways for WTX-124.
• Leveraging Fast Track Designation for WTX-124.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Key Resources

You're looking at the core assets Werewolf Therapeutics, Inc. is banking on to drive value, and honestly, it all comes down to proprietary science and the cash to keep the lights on while that science matures. The most fundamental resource here is the proprietary PREDATOR® conditional activation platform technology. This isn't just a catchy name; it's the engineering backbone that uses clinically validated protease-cleavable linkers to ensure their drug candidates activate selectively inside the tumor microenvironment, which is how they aim to improve the therapeutic index over standard treatments. This platform has already generated three clinical-stage INDUKINE candidates.

To map out these key scientific assets, look at the table below. It gives you a snapshot of what's in the engine room right now:

Financially, you need to know the runway. As of September 30, 2025, Werewolf Therapeutics, Inc. reported $65.7 million in cash and cash equivalents. That's down from $77.6 million at the end of Q2 2025, showing the burn rate associated with advancing these programs. The good news, though, is that management believes this cash position is sufficient to fund operations into the fourth quarter of 2026, giving them runway through key data readouts.

The human capital is definitely a resource, too. You have experienced leadership driving this science. Daniel J. Hicklin, Ph.D., serves as President and Chief Executive Officer, guiding the overall strategy. Plus, Randi Isaacs, M.D., is the Chief Medical Officer, providing the clinical direction for these novel molecules. Honestly, in biotech, the team that invented the tech is often as valuable as the patents themselves. You'll want to track their progress closely, defintely.

• Proprietary PREDATOR® platform technology.
• Lead INDUKINE candidate WTX-124 has Fast Track Designation.
• Cash runway extends into the fourth quarter of 2026.
• Key personnel include CEO Daniel J. Hicklin, Ph.D., and CMO Randi Isaacs, M.D.

Finance: draft the 13-week cash flow projection incorporating Q4 2025 SITC data impact by Friday.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Value Propositions

You're looking at the core promise Werewolf Therapeutics, Inc. is making to the market-it all boils down to making cancer immunotherapy safer and more effective by keeping the drug activity locked down until it reaches the tumor. That's the essence of their conditionally activated approach.

The proprietary PREDATOR® platform is key here, using clinically validated protease-cleavable linkers to ensure tumor-selective activation, which is designed to improve the therapeutic index significantly. Honestly, that's the main differentiator from older, systemic cytokine therapies.

The value proposition centers on minimizing the severe toxicities seen with older recombinant versions of these powerful immune signals. For instance, preclinical data presented at the 2025 Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting showed that sequential administration of their IL-2 and IL-12 INDUKINE molecules provided enhanced anti-tumor activity in mice bearing EMT6 tumors without systemic toxicity.

This selective activation is backed by hard data. First-in-kind real-time pharmacokinetic data in a mouse tumor model confirmed WTX-124's selective activation within tumors, which means healthy tissue is spared. This precision is what you're paying for, strategically speaking.

The company is actively pursuing combination strategies, which adds significant commercial value. WTX-124, their IL-2 INDUKINE molecule, is being developed both as a single agent and in combination with pembrolizumab. You should watch for the interim data readout from these combination expansion arms, which is anticipated in the fourth quarter of 2025.

Here's a quick look at the lead INDUKINE assets that embody this value proposition:

The company is also extending this conditional activation concept into a new modality with their INDUCER T-cell engagers. This is a play to capture value in another hot area of oncology while maintaining their core safety advantage.

The INDUCER platform uses a novel masking strategy on the anti-CD3 domain to prevent systemic T cell activation and cytokine release in preclinical models. This is designed to improve the therapeutic index for T-cell engagers, which are notorious for causing systemic toxicity.

The first development candidate in this class is WTX-1011. You need to know the specifics:

• WTX-1011 targets STEAP1 for prostate cancer.
• It is currently in IND-enabling studies as of Q3 2025.
• The company planned to nominate a differentiated target candidate by year-end 2025.

From a financial stability perspective, which underpins the ability to deliver these value propositions, Werewolf Therapeutics reported $65.7 million in cash and cash equivalents as of September 30, 2025. Management believes this cash position is sufficient to fund operations into the fourth quarter of 2026, giving them runway through key data readouts. Still, R&D expenses were $11.6 million in Q3 2025, reflecting the ongoing investment required to prove out this technology.

If onboarding for the WTX-124 combination arms takes longer than expected past the Q4 2025 data catalyst, cash burn could accelerate relative to expectations, so watch that timeline closely. Finance: draft 13-week cash view by Friday.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Customer Relationships

You're managing relationships with clinical sites, investors, and regulators all at once; it's a lot of moving parts, but the quality of these interactions directly fuels the next stage of Werewolf Therapeutics, Inc.'s development.

High-touch, direct engagement with clinical investigators and sites

The core of Werewolf Therapeutics, Inc.'s early customer relationship is with the clinical investigators and the sites running the trials for its lead candidates. This is a highly specialized, direct engagement model necessary for novel therapies.

For the WTX-124 Phase 1/1b clinical trial, all expansion arms are actively enrolling patients at a recommended dose of 18 mg administered intravenously every two weeks (IV Q2W). Enrollment across all arms is expected to be complete by the first quarter of 2026. This focused dosing and enrollment strategy requires close, direct communication with site Principal Investigators to ensure protocol adherence and timely data collection.

The relationship management extends across several indications and trial types:

• WTX-124 monotherapy and combination expansion arms include patients with cutaneous melanoma and renal cell carcinoma.
• The WTX-330 Phase 1b/2 clinical trial is also actively enrolling, with a determination of the dosing regimen anticipated by the end of 2025.
• The company is advancing preclinical candidates like WTX-1011, which targets STEAP1 for prostate cancer, requiring early engagement with experts in those specific tumor types for future trial planning.

Investor relations and scientific communication via conferences (e.g., SITC)

Managing investor and scientific community relationships involves consistent communication of data milestones. Werewolf Therapeutics, Inc. actively participated in key industry events to validate its PREDATOR platform.

The company presented scientific data at the 2025 Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, where three posters were presented, including data on sequential administration of WTX-124 and mWTX-330. Also in 2025, management participated in fireside chats at conferences such as the Leerink Partners Global Biopharma Conference in March and the H.C. Wainwright 27th Annual Global Investment Conference in September.

Financial updates also inform this relationship:

• Cash and cash equivalents were $65.7 million as of September 30, 2025.
• The company projected this cash position would fund operations into the fourth quarter of 2026.
• The net loss for Q3 2025 was $16.4 million.

Regulatory dialogue with the FDA for potential accelerated approval pathways

Direct engagement with the U.S. Food & Drug Administration (FDA) is a critical relationship for defining the path to market. Werewolf Therapeutics, Inc. has prioritized these interactions based on clinical progress.

A key milestone was receiving Fast Track Designation for WTX-124 for locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy on October 8, 2025. Furthermore, the company planned to release interim data from the WTX-124 expansion arms in the fourth quarter of 2025 and provide feedback from its End of Phase 1 meeting with the FDA during the same period. This feedback is expected to provide insight into potential registrational pathways for WTX-124.

The plan for 2025 included engaging with regulatory authorities in the second half of 2025 to discuss these potential registrational pathways, including strategies for accelerated approval. The WTX-330 program also anticipates an update on its potential development plan in the fourth quarter of 2025.

Future relationship management with pharmaceutical partners

Securing strategic partnerships is a key component of Werewolf Therapeutics, Inc.'s long-term strategy, particularly for its preclinical pipeline. In 2025, the company planned to complete preclinical work for candidates like WTX-712 (IL-21 INDUKINE), WTX-518 (IL-18 INDUKINE), and WTX-921 (IL-10 INDUKINE) and actively seek strategic partnerships to advance these programs. However, existing collaboration revenue was zero in Q3 2025 due to a transfer agreement with Jazz Pharmaceuticals, which impacted reported collaboration revenue for that period.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Channels

You're hiring before product-market fit, which means your primary channels right now are focused on generating clinical data and securing regulatory feedback, not selling product. Honestly, the channels are entirely centered on the science and the FDA right now. Here's the quick math: as of September 30, 2025, Werewolf Therapeutics, Inc. had $65.7 million in cash and cash equivalents, projecting a runway into the fourth quarter of 2026 to support these critical, data-generating channels.

Global network of clinical trial sites and hospitals

The current channel for product validation is the network of clinical trial sites running the INDUKINE programs. These sites are the physical conduits for generating the data needed to prove the value proposition of WTX-124 and WTX-330. The Phase 1/1b trial for WTX-124 is described as open-label and multicenter, indicating a distributed network of investigators and hospitals across the US, at minimum.

The company's operating expenses for Q3 2025 were $15.7 million, a significant portion of which flows directly into funding these clinical channels.

Scientific publications and conference presentations

Scientific dissemination acts as a crucial channel for validating the PREDATOR platform to the broader scientific community, potential partners, and key opinion leaders. This builds credibility outside of the formal regulatory process. Werewolf Therapeutics, Inc. actively used the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting in November 2025 as a primary channel for this communication.

• Presented a total of three posters at the SITC 40th Annual Meeting (November 5-9, 2025).
• Poster on WTX-124 covered Pharmacokinetic insight and real-time assessment of tumor-specific activation.
• Poster on sequential administration of WTX-124 and mWTX-330 showed enhanced anti-tumor activity in mice bearing EMT6 tumors.

Direct regulatory submissions to the FDA and other health authorities

Direct engagement with the U.S. Food and Drug Administration (FDA) is the most critical channel for determining the path to market. This channel is currently focused on gaining agreement on registrational pathways for the lead candidate, WTX-124.

• WTX-124 received Fast Track Designation from the FDA on October 8, 2025, for locally advanced or metastatic cutaneous melanoma post-standard of care immunotherapy.
• Planned an End of Phase 1 meeting with the FDA for WTX-124 in the fourth quarter of 2025.
• The goal of these interactions is to gain insight into potential registrational pathways for WTX-124.

The company's market capitalization as of early December 2025 was approximately $48.5 million, underscoring the high-risk, high-reward nature of relying heavily on this regulatory channel before commercialization.

Future specialized pharmaceutical sales force (post-approval)

As of late 2025, Werewolf Therapeutics, Inc. has zero commercial sales force infrastructure in place, which is typical for a company with a net loss of $16.4 million in Q3 2025 and no revenue recognized in that quarter. The establishment of a specialized sales force channel is entirely contingent upon successful navigation of the regulatory channels and securing future funding, as the current cash position is guided to last only into Q4 2026.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Customer Segments

You're looking at the key groups Werewolf Therapeutics, Inc. (HOWL) targets to drive adoption and secure capital for its pipeline of conditionally activated therapeutics. Here's the breakdown of those segments based on late 2025 data.

Oncologists and hematologists treating advanced solid tumors

These clinicians are the gatekeepers for the company's clinical assets, WTX-124 and WTX-330. The focus is on patients who have exhausted standard options, like those treated with immune checkpoint inhibitors (ICI).

• WTX-124 is being tested in expansion arms for metastatic melanoma, RCC (Renal Cell Carcinoma), and CSCC (Cutaneous Squamous Cell Carcinoma) at a recommended dose of 18 mg IV Q2W.
• WTX-124 combination arms include metastatic melanoma, RCC, and NSCLC (Non-Small Cell Lung Cancer).
• WTX-330 is in a Phase 1b/2 trial for advanced or metastatic solid tumors and lymphoma, with regimen determination targeted by the end of 2025.
• WTX-124 received Fast Track Designation from the FDA for post-ICI cutaneous melanoma.
• The company plans FDA engagement in the second half of 2025 to discuss potential registrational pathways for WTX-124.

Patients with immunotherapy-resistant or advanced/metastatic cancers (e.g., melanoma)

This segment represents the direct end-users of the therapeutic candidates, defined by their specific disease stage and prior treatment history. The clinical trial design directly addresses their unmet needs.

Large pharmaceutical and biotechnology companies for out-licensing

These entities are crucial for funding later-stage development and commercialization. Werewolf Therapeutics, Inc. is actively positioning its preclinical assets for these transactions.

• Werewolf plans to seek strategic partnerships to advance preclinical candidates WTX-712 (IL-21 INDUKINE), WTX-518 (IL-18 INDUKINE), and WTX-921 in 2025.
• The company announced WTX-1011, its first INDUCER T-cell engager development candidate, in Q2 2025, broadening potential partnering options.
• The company reported $0 in collaboration revenue for Q3 2025, as the Jazz Pharmaceuticals agreement revenue recognition substantially completed in mid-2024.

Institutional and retail investors (HOWL shareholders)

This segment provides the necessary capital to fund operations through clinical milestones. The stock performance and institutional positioning reflect their current sentiment.

As of November 28, 2025, the share price was $1.00 per share, down from $1.96 on December 2, 2024. The total valuation, or market cap, stood at $48.36 million, with an enterprise value of $19.95 million. The company has 48.54 million shares outstanding.

Institutional interest involves 113 institutional owners filing forms. Key holders include Ra Capital Management, L.p., and MPM Asset Management Llc.

Analyst sentiment shows a median price target of $5.50 over the last six months, with a consensus rating of 'Strong Buy'. The company reported a Q3 2025 net loss of $16.4 million, with cash and cash equivalents of $65.7 million as of September 30, 2025. Management guidance projects this cash position will fund operations through at least the fourth quarter of 2026.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Cost Structure

You're looking at the cost side of Werewolf Therapeutics, Inc. (HOWL) as of late 2025, and honestly, it looks exactly like what you'd expect from a company deep in clinical development. The cost structure is almost entirely dominated by the science and the trials needed to prove that science works.

The single biggest expense category is, without question, Research and Development (R&D) expenses. This covers everything from bench science to the expensive process of running human trials for your lead assets, WTX-124 and WTX-330. For the third quarter of 2025, R&D expenses clocked in at $11.6 million. That number represents the core investment you're making to move your PREDATOR® platform candidates toward potential registration.

Then you have the necessary corporate overhead, which falls under General and administrative (G&A) costs. These costs cover the corporate infrastructure-legal, finance, HR, and general operations that keep the lights on while the scientists are working. For Q3 2025, G&A costs were $4.1 million. It's a smaller piece of the pie compared to R&D, but still a significant fixed cost base to manage.

When we talk about the R&D spend, a huge chunk of that is dedicated to clinical trial costs. These aren't just one-time fees; they are ongoing, material expenditures. Think about the costs associated with running the Phase 1/1b trial for WTX-124 and the Phase 1b/2 trial for WTX-330. These costs include things like patient enrollment fees paid to clinical sites, the supply chain management for the drug product itself, and the monitoring required by regulatory bodies. If onboarding takes 14+ days, site management costs rise, which is a real operational risk in this phase.

Here's a quick look at the primary cost components for the third quarter of 2025, which really drives the overall operating expense profile:

The clinical development activities are the main cost engine, and you can see the impact on the bottom line, with the net loss for Q3 2025 reported at $16.4 million. The company's cash position as of September 30, 2025, was $65.7 million, which they project funds operations into the fourth quarter of 2026. That runway is directly tied to keeping these R&D costs controlled.

The major drivers within the R&D spend that you need to keep an eye on include:

• Patient enrollment for WTX-124 and WTX-330 expansion arms.
• Site fees for ongoing clinical trial execution.
• Manufacturing and supply of INDUKINE™ drug product.
• Activities for IND-enabling studies for WTX-1011.

To be fair, the G&A spend is relatively lean compared to the R&D burn, which is typical for a clinical-stage biotech focused on platform technology. Finance: draft 13-week cash view by Friday.

Werewolf Therapeutics, Inc. (HOWL) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Werewolf Therapeutics, Inc. (HOWL) as of late 2025, which, honestly, is typical for a company deep in clinical development. The current reality is that revenue is almost entirely non-operational, meaning it comes from partners or financing, not selling a drug.

Currently $0 in collaboration revenue for Q3 2025

For the third quarter ending September 30, 2025, Werewolf Therapeutics reported $0.00 in collaboration revenue. This zero figure is notable because a prior transfer agreement with Jazz Pharmaceuticals resulted in the elimination of collaboration revenue in Q3 2025. This means the primary non-dilutive revenue source seen in prior periods was absent this quarter.

Here's a quick look at the Q3 2025 financial context surrounding this revenue absence:

The company has explicitly stated they have no products approved for commercial sale and have not generated any revenue from product sales. That's the baseline for any pre-commercial biotech.

Future milestones and royalties from new strategic licensing agreements

The core of future non-dilutive revenue hinges on hitting clinical and regulatory milestones for their pipeline candidates, WTX-124 and WTX-330. These are the triggers for milestone payments and subsequent royalty streams from any licensing deals, like the one previously mentioned with Jazz Pharmaceuticals.

• WTX-124: Updates on interim Phase 1/1b data and FDA End of Phase 1 feedback expected in late Q4 2025.
• WTX-330: Phase 1b/2 trial update anticipated in Q4 2025.
• INDUCER Program: Expect nomination of a differentiated target candidate (WTX-1011) in Q4 2025.

These developments are what unlock the next tranches of potential upfront payments, development milestones, and eventual royalties from partners.

Potential product sales revenue upon regulatory approval of lead candidates (long-term)

This stream is purely long-term and contingent on successful clinical development and regulatory approval for WTX-124 and WTX-330. Currently, Werewolf Therapeutics, Inc. has no revenue from product sales. Should they achieve approval, revenue would shift to product sales, subject to market penetration, pricing, and reimbursement success.

Proceeds from equity issuance to fund operations (e.g., ATM offerings)

Since operational cash burn is high-reflected in the net loss-external financing is a necessary, albeit dilutive, revenue stream to sustain operations. During Q3 2025, the company actively raised capital through equity issuance.

• Proceeds from an at-the-market (ATM) offering of common stock during the Q3 2025 period totaled $3.6 million.
• Total cash generated from financing activities in Q3 2025 was reported as $3.27 million.

The company has signaled a need for substantial additional funding to complete development, and this equity issuance is a direct source of cash to bridge that gap. Still, the company disclosed a 'substantial doubt' about its ability to continue as a going concern, meaning this financing stream is critical for the next 12 months of operations. Finance: draft 13-week cash view by Friday.