[Executive Summary](index=1&type=section&id=Executive%20Summary) 4D Molecular Therapeutics reported Q2 2025 financial results, highlighted operational advancements, and outlined upcoming milestones, including accelerating the 4D-150 program for wet AMD and presenting positive 60-week data for 4D-150 in DME - 4D Molecular Therapeutics reported Q2 2025 financial results, highlighted operational advancements, and outlined upcoming milestones, including accelerating the 4D-150 program for wet AMD and presenting positive 60-week data for 4D-150 in DME[1](index=1&type=chunk)[2](index=2&type=chunk)[3](index=3&type=chunk) - The 4D-150 program for wet AMD saw accelerated timelines, with **4FRONT-1 data expected H1 2027** (from H2 2027) and **4FRONT-2 initiated ahead of schedule**[3](index=3&type=chunk)[5](index=5&type=chunk) - Positive **60-week data** from the SPECTRA trial in DME supported favorable tolerability, sustained durability, and meaningful treatment burden reduction[3](index=3&type=chunk)[5](index=5&type=chunk) - FDA and EMA aligned that a single successful **Phase 3 study** could support approval for 4D-150 in DME[3](index=3&type=chunk) - The company streamlined its organization with a **25% workforce reduction** to focus on late-stage execution, extending its cash runway into **2028**[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) [Recent Corporate Highlights & Operational Milestones](index=1&type=section&id=Recent%20Corporate%20Highlights%20%26%20Operational%20Milestones) [Organizational Streamlining](index=1&type=section&id=Organizational%20Streamlining) 4DMT streamlined its organization by reducing its workforce by approximately 25% in July 2025, primarily impacting early-stage R&D and support functions, projecting $15 million in annual cash compensation cost savings and extending its cash runway into 2028 - Workforce reduction: Approximately **25%** of current and planned roles in **July 2025**, primarily in early-stage research and development and support functions[6](index=6&type=chunk) - Cost savings: Expected annual cash compensation cost savings of approximately **$15 million**[6](index=6&type=chunk) - Cash runway: The workforce reduction supports the Company's cash runway into **2028**, as previously guided[5](index=5&type=chunk)[6](index=6&type=chunk) [4D-150 Program (Ophthalmology)](index=1&type=section&id=4D-150%20Program%20%28Ophthalmology%29) The 4D-150 program demonstrated significant progress with accelerated timelines for its Phase 3 trials in wet AMD, including earlier data readouts and ahead-of-schedule initiation of 4FRONT-2, while for DME, positive 60-week SPECTRA data confirmed favorable tolerability and substantial reduction in injection burden, leading to regulatory alignment for a single Phase 3 study and RMAT designation [4D-150 for Wet Age-related Macular Degeneration (Wet AMD)](index=1&type=section&id=4D-150%20for%20Wet%20Age-related%20Macular%20Degeneration%20%28Wet%20AMD%29) - **4FRONT-1 data readout**: Expected to accelerate to **H1 2027** from H2 2027[5](index=5&type=chunk) - **4FRONT-2 initiation**: The second **Phase 3 trial** was initiated in **June 2025**, ahead of schedule[8](index=8&type=chunk) - **4FRONT-2 data readout**: **52-week topline data** for 4FRONT-2 are expected in **H2 2027**[8](index=8&type=chunk) - Enrollment: Initial enrollment and site activation for **4FRONT-1** have exceeded initial projections, reflecting strong engagement[6](index=6&type=chunk)[7](index=7&type=chunk) [4D-150 for Diabetic Macular Edema (DME)](index=2&type=section&id=4D-150%20for%20Diabetic%20Macular%20Edema%20%28DME%29) - **SPECTRA 60-week results**: 4D-150 continues to be well-tolerated, with no intraocular inflammation observed and all patients currently off corticosteroids[8](index=8&type=chunk) - Clinical activity (**Phase 3 dose**): Demonstrated strong signals of clinical activity with a sustained gain of **BCVA of +9.7 letters** and reduction of **CST of -174 µm** from baseline[8](index=8&type=chunk) - Injection burden reduction (**Phase 3 dose**): Achieved **78% reduction** in injection burden vs. projected on-label aflibercept 2mg Q8W[8](index=8&type=chunk) - Regulatory alignment: FDA and EMA are aligned that a single **Phase 3 clinical trial** could be acceptable for marketing authorization submission[8](index=8&type=chunk) - Designation: Received **Regenerative Medicine Advanced Therapy (RMAT) designation** from the FDA for 4D-150 for the treatment of DME[8](index=8&type=chunk) [Pulmonology Program (4D-710 for Cystic Fibrosis)](index=3&type=section&id=Pulmonology%20Program%20%284D-710%20for%20Cystic%20Fibrosis%29) The pulmonology program for 4D-710 in Cystic Fibrosis Lung Disease completed enrollment for Cohort 4 of its Phase 1 AEROW clinical trial, bringing the total to 16 participants, with interim data and a program update anticipated in Q4 2025 - **AEROW trial enrollment**: Completed enrollment of **Cohort 4 (n=6)** in **Phase 1 stage**, completing total enrollment of **n=16 participants**[14](index=14&type=chunk) - Upcoming milestone: Interim data from AEROW clinical trial and program update expected in **Q4 2025**[14](index=14&type=chunk) [Q2 2025 Financial Results](index=3&type=section&id=Q2%202025%20Financial%20Results) [Cash Position](index=3&type=section&id=Cash%20Position) As of June 30, 2025, 4DMT reported $417 million in cash, cash equivalents, and marketable securities, a decrease from $505 million at the end of 2024, primarily due to operational cash usage, with this balance projected to fund planned operations into 2028 Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :----------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | $417,031 | $505,460 | - The net decrease in cash was primarily a result of cash used in operations[9](index=9&type=chunk) - Cash, cash equivalents and marketable securities are expected to be sufficient to fund planned operations into **2028**[9](index=9&type=chunk) [Statements of Operations](index=3&type=section&id=Statements%20of%20Operations) For Q2 2025, 4DMT's net loss widened to $54.7 million (vs. $35.0 million in Q2 2024), driven by a significant increase in R&D expenses to $48.0 million (vs. $31.9 million) due to the initiation of the 4D-150 Phase 3 trial, with G&A expenses also increasing to $11.5 million (vs. $10.6 million), resulting in a net loss per share of $(0.98) Q2 2025 Statements of Operations Highlights | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | YoY Change | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | | Collaboration and license revenue | $15 | $5 | +$10 | | Research and development expenses | $47,951 | $31,860 | +$16,091 | | General and administrative expenses | $11,520 | $10,601 | +$919 | | Total operating expenses | $59,471 | $42,461 | +$17,010 | | Loss from operations | $(59,456) | $(42,456) | -$(17,000) | | Other income, net | $4,798 | $7,503 | -$(2,705) | | Net loss | $(54,658) | $(34,953) | -$(19,705) | | Net loss per share, basic and diluted | $(0.98) | $(0.63) | -$(0.35) | - Research and development expenses increased primarily due to the initiation of the first **Phase 3 clinical trial of 4D-150** in wet AMD, including increased personnel and professional services[10](index=10&type=chunk) - General and administrative expenses increased primarily due to increased use of professional services[11](index=11&type=chunk) [Balance Sheet Data](index=6&type=section&id=Balance%20Sheet%20Data) As of June 30, 2025, total assets decreased to $473.6 million from $560.4 million at year-end 2024, while total liabilities slightly increased to $52.7 million, with the accumulated deficit growing to $678.8 million, leading to a reduction in total stockholders' equity to $420.9 million Balance Sheet Data Highlights | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total assets | $473,637 | $560,384 | | Total liabilities | $52,747 | $49,778 | | Accumulated deficit | $(678,825) | $(576,195) | | Total stockholders' equity | $420,890 | $510,606 | [About 4D Molecular Therapeutics (4DMT)](index=3&type=section&id=About%204DMT) - **4DMT** is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms[12](index=12&type=chunk) - Lead product candidate **4D-150** is designed as a backbone therapy for blinding retinal vascular diseases (wet AMD, DME) to provide multi-year sustained delivery of anti-VEGF with a single, safe, intravitreal injection[12](index=12&type=chunk) - Second product candidate **4D-710** is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery[12](index=12&type=chunk) - All product candidates are in clinical or preclinical development and have not yet been approved for marketing by regulatory authorities[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) - This press release contains forward-looking statements regarding therapeutic potential, clinical benefits, development plans, regulatory interactions, financial performance, and anticipated cash runway[14](index=14&type=chunk)[15](index=15&type=chunk) - Statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially, as described in SEC filings[15](index=15&type=chunk) - **4D Molecular Therapeutics** explicitly disclaims any obligation to update any forward-looking statements[15](index=15&type=chunk) [Contacts](index=6&type=section&id=Contacts) - Media Contact: Jenn Gordon, dna Communications, Media@4DMT.com[20](index=20&type=chunk) - Investors Contact: Julian Pei, Head of Investor Relations and Strategic Finance, Investor.Relations@4DMT.com[20](index=20&type=chunk)

Core Viewpoint - 4D Molecular Therapeutics reported advancements in its 4D-150 program, with accelerated timelines for clinical trials and a strong cash position to support operations into 2028 [1][2][8]. Recent Corporate Highlights - The company streamlined operations, reducing workforce by approximately 25%, primarily in early-stage research and development, to save about $15 million annually [7]. - Positive 60-week data from the SPECTRA trial in Diabetic Macular Edema (DME) supports the therapy's tolerability and treatment burden reduction [6][11]. - The 4FRONT-1 trial for wet Age-related Macular Degeneration (AMD) has exceeded initial enrollment projections, with topline data expected in the first half of 2027, accelerated from the second half of 2027 [6][7]. Financial Results - As of June 30, 2025, the company reported cash, cash equivalents, and marketable securities of $417 million, down from $505 million at the end of 2024, primarily due to operational cash usage [8][19]. - Research and development expenses increased to $48.0 million in Q2 2025 from $31.9 million in Q2 2024, driven by the initiation of the Phase 3 clinical trial for 4D-150 [9]. - General and administrative expenses rose to $11.5 million in Q2 2025 from $10.6 million in Q2 2024, mainly due to increased professional services [10]. Expected Milestones - The company anticipates 52-week topline data for the 4FRONT-2 trial in wet AMD in the second half of 2027 [7]. - Data from the PRISM Phase 1/2 clinical trial is expected in Q4 2025 [7]. - The company received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 4D-150 for DME, indicating potential expedited development [11].

Core Insights - The broader stock market experienced significant losses due to trade policy changes and negative economic data, while select health technology stocks, including 4D Molecular Therapeutics, Sensei Biotherapeutics, and Alphatec Holdings, saw substantial gains averaging around 37% [1] Group 1: 4D Molecular Therapeutics - Shares of 4D Molecular Therapeutics surged over 42% to close at $6.42 following the release of promising clinical data for its gene therapy candidate, 4D-150, targeting diabetic macular edema and wet age-related macular degeneration [2] - The therapy showed strong, dose-dependent results, with a reported 78% reduction in treatment burden at the Phase 3 dose compared to standard aflibercept dosing, along with sustained visual improvements and no reported inflammation [4] - The European Medicines Agency endorsed the company's plan to seek approval based on a single Phase 3 trial, aligning with earlier FDA guidance [5] Group 2: Sensei Biotherapeutics - Sensei Biotherapeutics emerged as a top gainer despite no major company-specific news, likely due to increased speculative interest in its immuno-oncology pipeline and anticipation of upcoming trial data [6] - The stock rose 38% to close at $10.32, following the announcement that Sensei will present clinical data from its Phase 1/2 trial of its lead candidate at the European Society for Medical Oncology Congress on October 17 [7] Group 3: Alphatec Holdings - Alphatec Holdings' stock jumped 30% to close at $13.77 after the company raised its full-year 2025 revenue outlook to $742 million, driven by strong demand for its surgical platforms and EOS imaging technologies [9] - The company reported second-quarter 2025 revenue of $185.5 million, reflecting a 28% year-over-year increase, although it also reported a widened net loss of $41.1 million, or $0.27 per share [11] - Despite remaining unprofitable, investor confidence appears to be increasing in Alphatec's commercial execution and long-term growth prospects [12]

Core Viewpoint - 4D Molecular Therapeutics announced positive results from the SPECTRA clinical trial for 4D-150 in diabetic macular edema (DME), indicating a potential shift in treatment paradigms and alignment with the European Medicines Agency (EMA) for a registrational pathway [1][6]. Clinical Trial Results - The SPECTRA trial demonstrated that 4D-150 is well tolerated with no intraocular inflammation observed at any timepoint or dose level [4] - The Phase 3 dose of 4D-150 achieved a clinically meaningful 78% reduction in treatment burden compared to the standard-of-care aflibercept 2mg every eight weeks [4][10] - Efficacy results showed a sustained gain in best corrected visual acuity (BCVA) of +9.7 letters and a reduction in central subfield thickness (CST) of -174 µm [5] Regulatory Alignment - Both the FDA and EMA have aligned on a single Phase 3 clinical trial as acceptable for regulatory submission for 4D-150 in DME, streamlining the path for marketing authorization [6][9] Product Overview - 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF from a single intravitreal injection, aiming to reduce the treatment burden associated with current therapies [7][9] - The investigational agent targets both wet age-related macular degeneration and DME, addressing significant unmet medical needs in these conditions [7][11] Market Context - DME is a prevalent complication of diabetic retinopathy, affecting approximately one million individuals in the U.S., characterized by inflammation and swelling in the macula leading to vision loss [8]

Core Insights - 4D Molecular Therapeutics is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics that aim to transform treatment paradigms and provide significant benefits to patients [3]. Presentation Details - The company will present interim results from the SPECTRA Phase 2a clinical trial evaluating intravitreal 4D-150 in adults with diabetic macular edema on July 31, 2025 [2]. - The presentation will include a 52-week primary endpoint analysis and a 60-week analysis, with all patients having reached 60 weeks as of the data cutoff date of May 2, 2025 [2]. - Additionally, results from the PRISM Phase 2b clinical trial evaluating intravitreal 4D-150 in adults with neovascular age-related macular degeneration will be presented on August 1, 2025 [2]. Product Candidates - The lead product candidate, 4D-150, is designed to provide multi-year sustained delivery of anti-VEGF therapies through a single intravitreal injection, significantly reducing the treatment burden associated with current bolus injections [3]. - 4D-150 is currently in Phase 3 development for wet age-related macular degeneration and is also being studied for diabetic macular edema [3]. - The second product candidate, 4D-710, is the first known genetic medicine to successfully deliver and express the CFTR transgene in the lungs of cystic fibrosis patients after aerosol delivery [3].

4D-150 Clinical Activity and Tolerability - 4D-150 demonstrates robust and durable clinical activity across all studied populations, including recently diagnosed patients with wet AMD[7] - 4D-150 exhibits a tolerability profile comparable to approved anti-VEGF agents[8] 4D-150 Injection-Free Rates in Wet AMD - In the severe wet AMD population, 44% of patients were injection-free through 52 weeks, with 48% requiring >1 injection and 8% requiring 1 injection, resulting in an 83% treatment burden reduction[13] - In the broad wet AMD population (including recently diagnosed), 70% of patients were injection-free through 52 weeks, with 20% requiring >1 injection and 10% requiring 1 injection, resulting in an 89% treatment burden reduction[16] - In the recently diagnosed wet AMD population, 87% of patients were injection-free through 52 weeks, with 13% requiring 1 injection, resulting in a 98% treatment burden reduction[19] 4D-150 Intraocular Inflammation (IOI) Profile - 4D-150 development is enabled by a favorable IOI profile, with IOI rates of 2-3%[22] 4FRONT Phase 3 Program Design - The 4FRONT Phase 3 program in treatment-naïve wet AMD is designed to maximize the probabilities of clinical, regulatory, and commercial success[10, 24, 35] - The 4FRONT-1 Phase 3 study's primary endpoint is BCVA noninferiority of 4D-150 3E10 vg/eye to Aflibercept 2mg Q8 weeks[33]

Core Insights - 4D Molecular Therapeutics is accelerating the 4D-150 4FRONT Phase 3 program for wet age-related macular degeneration (wet AMD) and has streamlined operations to manage increased expenses, ensuring cash runway into 2028 [1][6] - The company anticipates topline data for the 4FRONT-1 trial in the first half of 2027, an acceleration from the previous guidance of the second half of 2027 [3][6] - A workforce reduction of approximately 25% is being implemented to achieve annual cash compensation savings of about $15 million, supporting the accelerated clinical trial timelines [6] Company Overview - 4D-150 is designed as a backbone therapy for retinal vascular diseases, providing multi-year sustained delivery of anti-VEGF through a single intravitreal injection [5][9] - The company has a strong cash position with $458 million in cash, cash equivalents, and marketable securities as of March 31, 2025, sufficient to support ongoing clinical trials and preparations [6] - The company is transitioning towards becoming a commercial entity, focusing on delivering transformative genetic medicines to patients [4][9] Clinical Development - Initial enrollment and site activation for the 4FRONT-1 trial have exceeded projections, indicating strong engagement from investigators and patients [6] - The 4FRONT-2 trial has been initiated ahead of schedule, with topline data expected in the second half of 2027 [5][6] - Wet AMD is a prevalent disease, with over 4 million individuals expected to be affected in major markets within the next five years [8]

4DMT's Pipeline and Financial Status - 4DMT is officially a Phase 3 company[6] - 4DMT had $505 million cash as of December 31, 2024, providing runway into 2028[57] - 4DMT's pipeline is focused on large market indications with high unmet need[56] 4D-150 for Wet AMD - 4D-150 is a Phase 3 therapeutic designed to disrupt the global market for retinal vascular diseases and improve patient outcomes[8, 10, 18, 27, 37, 43] - The global market for retinal vascular diseases is $17 billion+ and growing[9, 11, 19, 28, 39, 45] - Topline data from wet AMD pivotal trials in the 4FRONT global registration program are expected in H2 2027[9, 11, 19, 28, 40, 45] - 4D-150 demonstrated transformative treatment burden reduction, with a projected 83% to 94% reduction in mean annual injections post 4D-150 in Phase 1/2a and Phase 2b populations[26] - In a Wet AMD population, 2.8% of patients experienced treatment-related 1+ vitreous cells at a single timepoint[32] 4D-150 for DME - In DME patients, there was no intraocular inflammation at any timepoint at any dose level[33] Market Dynamics - The total branded anti-VEGF market continues to grow, driven by incremental durability improvements, with aflibercept remaining the market leader[12] - The anti-VEGF market is expected to reach $17.1 million[14]

Summary of 4D Molecular Therapeutics (FDMT) FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (FDMT) - **Focus**: Gene therapy with a focus on ophthalmology and pulmonology, specifically targeting conditions like wet age-related macular degeneration (AMD), diabetic macular edema (DME), and cystic fibrosis. Key Points Industry and Market Opportunities - **Gene Therapy Potential**: The company believes it has developed best-in-class vectors for various delivery methods, which opens up large sustainable markets in gene therapy [1][2] - **Market Size**: The potential market opportunities are significant, with estimates of 4,150 million for wet AMD and DME, and 4,710 million for cystic fibrosis lung disease [1] Clinical Development and Trials - **Phase III Trials**: The focus for the next twelve months is on executing Phase III trials for FORWARD I and FORWARD II in wet AMD and initial dose data for cystic fibrosis [2] - **Physician Feedback**: Positive feedback from physicians regarding the durability of treatments and reduced injection burden, with expectations of an 80-90% reduction compared to existing therapies [6][7] - **Safety Profile**: The company reports a strong safety profile with no inflammation observed in DME trials, which is critical for large markets like wet AMD and DME [9][10] Commercial Strategy - **Pricing Flexibility**: The cost of goods for treatments is around $500, allowing for competitive pricing strategies that can benefit patients and shareholders [26] - **Durability Demand**: Surveys indicate that durability and extended treatment duration are the top desires for both patients and physicians, positioning gene therapy as a leading option [22] Regulatory and Financial Position - **Regulatory Engagement**: Ongoing discussions with the FDA regarding potential accelerated approval pathways for cystic fibrosis treatments, especially for patients with no available therapies [41][43] - **Financial Health**: The company ended Q1 with $458 million in cash, primarily allocated to fund Phase III trials for wet AMD, with a runway extending into 2028 [51] Future Directions - **Partnership Opportunities**: The company is open to partnerships outside the U.S. for its products, particularly in the lung franchise, while retaining U.S. rights for ophthalmology [48][49] - **Platform Development**: The gene therapy platform has shown broad utility, with six open INDs and a focus on developing a portfolio of products efficiently [45][54] Additional Insights - **Market Differentiation**: The company emphasizes that not all gene therapies are the same, highlighting its unique approach to local application and cost management, which differentiates it from other programs in the field [56] This summary encapsulates the key insights and strategic directions discussed during the conference call, providing a comprehensive overview of 4D Molecular Therapeutics' current status and future outlook in the gene therapy market.

Summary of Conference Call Company Overview - **Company**: 4D Molecular Therapeutix (4D MT) - **Lead Product**: 4,150 for wet Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) Industry Context - **Market Size**: The market for retinal vascular diseases is estimated to reach **$20 billion** by the time the product is launched [3] - **Current Treatments**: The current treatment landscape includes EYLEA and Vabismo, with a focus on improving durability and reducing treatment burden [29][30] Key Product Updates - **Clinical Trials**: The Forefront I Phase III trial is currently underway with over **50 clinical trial sites** activated, targeting a total of **100 sites** [2] - **Product Designation**: 4,150 is the first known genetic medicine to receive RMAT designation, indicating its potential as a breakthrough therapy for wet AMD and DME [3][46] - **Efficacy**: In Phase 1/2 trials, 4,150 demonstrated an **83% reduction** in injection burden for hard-to-treat patients, with some recently diagnosed patients showing over **90% reduction** [12][13] Core Product Advantages - **Durability and Safety**: The product aims to provide greater durability with a favorable safety profile, comparable to EYLEA [4][15] - **Treatment Burden Reduction**: The anticipated reduction in treatment burden is projected to be between **80% to 90%**, significantly higher than existing therapies [8][30] - **Patient Convenience**: The product is designed for seamless integration into clinical practice, allowing for routine intravitreal injections [4] Market Dynamics - **Physician Feedback**: There is significant interest from physicians and patients regarding gene therapy, with a focus on durability and treatment burden reduction [30][31] - **Payer Environment**: The majority of wet AMD patients are Medicare patients, which is seen as a favorable payer environment for launching the product [43] Regulatory Insights - **FDA Alignment**: The FDA has agreed that a single Phase III trial can serve as the basis for BLA submission for DME, which is a significant regulatory milestone [51] - **RMAT Designation**: This designation is expected to facilitate more efficient interactions with regulatory bodies and potentially streamline the review process [46][47] Financial Considerations - **Cost of Goods**: The cost of goods for 4,150 is projected to be less than **$1,000**, providing flexibility in pricing strategies [44] - **Funding for DME Trial**: The company is exploring non-equity financing and partnerships for funding the DME trial, with current cash reserves sufficient to support wet AMD programs through data readout [53] Future Milestones - **Upcoming Data Releases**: Key data updates are expected in Q4 for Phase 1/2 trials, with continued updates on enrollment and site openings for Phase III trials [61] - **Cystic Fibrosis Program**: The company is also advancing its 4,710 product for cystic fibrosis, with updates expected in the second half of the year [25][59] Conclusion 4D Molecular Therapeutix is positioned to potentially revolutionize the treatment landscape for wet AMD and DME with its innovative gene therapy approach, focusing on significant reductions in treatment burden and improved patient outcomes. The company is actively engaging with regulatory bodies and exploring funding options to support its clinical programs.