WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced the company will hold a conference call and webcast on Monday, September 29 at 8:30 a.m. ET to share topline results from RSVHR, a Phase 2b study evaluating zelicapavir for the treatment of respiratory syncytial virus (RSV) in high-risk adults. Conference Call and Webcast. ...

Financial Data and Key Metrics Changes - Enanta Pharmaceuticals has evolved from a virology-focused company to include immunology in its pipeline, indicating a strategic shift in its business model [4][9] - The company reported positive Phase II data for its protease inhibitor EDP-235, which is aimed at treating SARS-CoV-2, and anticipates a clearer regulatory pathway for its development [8][9] Business Line Data and Key Metrics Changes - The company has two main programs targeting respiratory syncytial virus (RSV), focusing on N protein and L protein inhibitors, which aim to address the unmet need for active RSV infection treatments [6][7] - Enanta is also expanding into immunology with programs targeting KIT and STAT6, with the first program aimed at chronic spontaneous urticaria and the second aiming for an oral alternative to Dupixent [9][24] Market Data and Key Metrics Changes - The company is considering partnerships for its RSV assets, learning from its experience in hepatitis C, to maximize the potential of being the first to market in a new category [25] - The uptake of existing RSV vaccines has been low, with only about 20% of the target population vaccinated, indicating a significant market opportunity for effective antiviral treatments [40] Company Strategy and Development Direction - Enanta aims to leverage its expertise in virology and immunology to develop innovative treatments, with a focus on high-risk patient populations for RSV and mast cell-driven diseases [9][21] - The company plans to announce a third program in immunology later this year, further diversifying its pipeline [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the Phase II study for zelicapavir, which targets high-risk adults for RSV, and expects to report results soon [20][26] - The management highlighted the importance of early treatment in viral infections and the need for effective antiviral therapies, especially in high-risk populations [15][30] Other Important Information - Enanta is currently involved in litigation regarding its intellectual property related to SARS-CoV-2 treatments, with cases filed in both the US and EU [53][54] - The company is focused on developing potent and selective drug candidates, with ongoing IND enabling activities for its immunology programs [22][24] Q&A Session Summary Question: What is the expected duration of symptoms for placebo in a high-risk RSV study? - Management indicated that while specific data is not available, symptoms in high-risk populations are generally more prolonged compared to younger groups [28][30] Question: How important is virology in the context of secondary endpoints? - Management emphasized that while symptoms are crucial for registration, virology is also important as quicker viral knockdown correlates with faster symptom resolution [33][35] Question: Can you provide an update on the litigation with Pfizer regarding COVID therapeutics? - Management stated that there is limited information available but confirmed ongoing legal proceedings in both the US and EU regarding intellectual property related to SARS-CoV-2 [53][54]

Enanta Pharmaceuticals FY Conference Summary Company Overview - Enanta Pharmaceuticals specializes in virology, with a history in hepatitis C, having developed products like Viekira Pak and MAVYRET, the latter being the only eight-week cure for hepatitis C [2][3] - The company has expanded its focus to include respiratory syncytial virus (RSV) and immunology, with multiple programs in development [3][4] Key Programs and Developments Respiratory Syncytial Virus (RSV) - Enanta is developing Zelekapivir, which has completed pediatric trials and is nearing results from a high-risk adult study involving 186 patients [3][5] - The high-risk adult population includes individuals aged 65 and older, those with asthma, congestive heart failure, or COPD, with a focus on the most vulnerable groups [5][6] - The study aims for a clinically meaningful reduction in symptom duration, targeting at least a one-day improvement based on previous successful drug approvals for similar conditions [9][12] - Zelekapivir has shown a good safety profile in over 500 patients, comparable to placebo [18] Immunology Programs - Enanta is pursuing two immunology programs: one targeting mast cell diseases and another aiming for an oral alternative to Dupixent, focusing on STAT6 inhibition [10][11] - A third immunology program is expected to be announced later in the year, with a focus on well-understood biology and significant unmet medical needs [11][24] Regulatory Path and Market Opportunities - The regulatory pathway for Zelekapivir is expected to mirror that of other acute respiratory drugs, which have been approved based on symptom reduction data [14][15] - The company is exploring business development opportunities to partner for the commercialization of Zelekapivir and EDP-323, aiming for a first-to-market position in RSV therapeutics [20][22] Future Expectations - Enanta plans to report data from the high-risk adult study later this month, which will inform the design of a potential phase 3 study [12][16] - The company is focused on finalizing its development candidate for the STAT6 program and ensuring strong intellectual property protection [23] Conclusion - Enanta Pharmaceuticals is positioned to make significant advancements in the treatment of RSV and immunological conditions, with ongoing studies and a strategic approach to partnerships and regulatory pathways [25][26]

Summary of Enanta Pharmaceuticals (ENTA) Conference Call Company Overview - Enanta Pharmaceuticals, Inc. is focused on developing drugs in viral antivirals and immunology indications, with a strong historical emphasis on virology [6][5][1]. Key Points and Arguments Virology Focus - Enanta has a 20-year history in virology, initially working on hepatitis C, leading to the development of two marketed drugs: Viekira Pak and MAVYRET, with MAVYRET being the only eight-week cure for chronic and acute HCV [6][17]. - Recent efforts have shifted towards respiratory viruses, particularly respiratory syncytial virus (RSV), with two drug candidates, zilicapivir and EDP-323, currently in phase 2 development [6][7]. RSV High-Risk Adult Study - The high-risk adult study for zilicapivir is set to report results later this month, focusing on patients over 65 or those with conditions like COPD, asthma, or CHF [8][10]. - The study aims to enroll patients within 72 hours of symptom onset, with a primary endpoint based on symptom resolution using a patient-reported outcome tool [10][11]. Comparison with Other Treatments - The company is looking to demonstrate a clinically meaningful reduction in symptom duration, aiming for a one-day improvement, which aligns with historical benchmarks for approval in similar respiratory virus treatments [11][39]. - Previous studies for influenza and SARS-CoV-2 have shown that a one-day reduction in symptom duration is considered clinically meaningful [11][39]. Immunology Programs - Enanta is advancing its KIP program targeting mast cell-driven diseases and a STAT-6 program aimed at developing an oral alternative to Dupixent [14][15]. - The KIP program is expected to enter clinical trials early next year, with a candidate selection for the STAT-6 program anticipated in the second half of the year [15][16]. Acute HCV Treatment - The recent approval of MAVYRET for acute HCV treatment is significant as it allows for earlier intervention, potentially reducing the spread of the virus [17][18]. - The impact of this approval on Enanta's revenue is still being assessed, with expectations for a clearer picture emerging over the next few quarters [22]. RSV Treatment Landscape - The RSV treatment landscape is evolving, with a need for small molecule antivirals alongside existing prophylactic measures like monoclonal antibodies and vaccines [24][25]. - Current vaccine uptake is low, with only about 20% of the eligible population vaccinated, indicating a significant unmet need for effective treatments [25][26]. Pediatric Study Insights - A pediatric study involving 90 patients showed a 1.2 log drop in viral load, outperforming a benchmark study [34][35]. - The company is developing a new caregiver-reported outcome tool, Resolve-P, to better assess symptoms in future studies [38]. Future Expectations - Enanta aims to establish itself as a leader in RSV treatment, with the potential to be the first to market with a therapeutic option [40]. - The company is also exploring opportunities in the immunology space, which is seen as a growing area compared to virology [41]. Additional Important Information - The company has faced challenges in recruiting high-risk populations during the pandemic, impacting some of its studies [32]. - The potential for combination therapies with EDP-323 and zilicapivir is being explored, particularly for immunocompromised patients [31]. This summary encapsulates the key discussions and insights from the Enanta Pharmaceuticals conference call, highlighting the company's strategic focus and future directions in both virology and immunology.

Financial Position - As of June 30, 2025, the company had $204.1 million in cash, cash equivalents, and short-term marketable securities, expected to fund operations into fiscal 2028[69]. - The company anticipates that existing cash, cash equivalents, and short-term marketable securities will fund operations into fiscal 2028[83]. - Cash used in operating activities decreased by $55.6 million (81.3%) to $12.8 million for the nine months ended June 30, 2025, compared to $68.4 million in 2024, primarily due to lower R&D payments and a $33.8 million tax refund[121]. Revenue and Sales - Revenue for the three months ended June 30, 2025, was $18.3 million, a slight increase of $0.3 million compared to $18.0 million in the same period in 2024, primarily due to higher reported HCV sales by AbbVie[96]. - Revenue for the nine months ended June 30, 2025, was $50.2 million, a decrease of $2.8 million (5.3%) compared to $53.0 million in the same period in 2024, primarily due to lower reported HCV sales[110]. - Total royalty revenue for the three months ended June 30, 2025, was $18.3 million, compared to $17.9 million for the same period in 2024[84]. - The company continues to record 100% of HCV royalties earned under the AbbVie agreement as royalty revenue in its financial statements[80]. - Ongoing royalty revenues from the AbbVie agreement consist of annually tiered, double-digit royalties on 50% of the calendar year net sales of the glecaprevir/pibrentasvir combination in MAVYRET/MAVIRET[78]. Research and Development - The company is developing two clinical stage candidates for RSV: zelicapavir and EDP-323, with zelicapavir showing a viral load decline of 1.4 log at Day 5 compared to placebo in pediatric studies[71]. - EDP-235, an oral inhibitor targeting SARS-CoV-2, demonstrated a two-day shorter time to improvement in patients receiving 400 mg compared to placebo[73]. - The company plans to expand its immunology presence with a third program in 2025, focusing on oral STAT6 inhibitors for type 2 immune-driven diseases[75]. - The company’s RSV programs are expected to advance through potential partnerships, with ongoing Phase 2b studies in high-risk adult populations[71]. - EDP-323 achieved statistically significant reductions in viral load and clinical symptoms in a Phase 2a study, with p=<0.0001 compared to placebo[74]. - The company’s research and development efforts are focused on small molecule drugs for virology and immunology indications, leveraging its chemistry-driven approach[63]. - The company is conducting a Phase 2b study of zelicapavir in high-risk adults, which completed enrollment in May 2025[81]. - The company has a preclinical program for oral KIT inhibitors targeting CSU, with lead candidate EPS-1421 selected for further development[75]. Expenses - Research and development expenses for the three months ended June 30, 2025, decreased by $1.5 million to $27.2 million from $28.7 million in the same period in 2024[100]. - Total research and development expenses decreased by $17.8 million (17.6%) to $82.9 million for the nine months ended June 30, 2025, compared to $100.7 million in 2024[111]. - Virology program costs decreased by $19.8 million (27.5%) primarily due to the timing of clinical trials in RSV programs[112]. - Immunology program costs increased by $6.2 million (37.9%) due to the initiation of preclinical studies for the STAT6 program[113]. - General and administrative expenses decreased by $9.9 million (22.4%) to $34.2 million for the nine months ended June 30, 2025, compared to $44.2 million in 2024[115]. - Interest expense decreased by $3.1 million (37.1%) to $5.3 million for the nine months ended June 30, 2025, compared to $8.4 million in 2024[116]. - Interest and investment income, net, decreased by $4.2 million (36.3%) to $7.4 million for the nine months ended June 30, 2025, compared to $11.6 million in 2024[117]. Losses - Net loss for the nine months ended June 30, 2025, was $63.2 million, an improvement of $24.0 million (27.5%) compared to a net loss of $87.2 million in 2024[109]. - The company has not generated any revenue from its own product sales and does not expect to do so for at least the next several years[86]. Market Insights - The estimated global prevalence of chronic spontaneous urticaria (CSU) is between 0.5% – 1%, affecting approximately 1.75-3.5 million people in the U.S. alone[67]. - The hospitalization burden of RSV is significant, with estimates of 3 million hospitalizations globally in children under 5 years old and 177,000 in U.S. adults over 65[65].

Company Performance - Enanta Pharmaceuticals reported a quarterly loss of $0.85 per share, which was better than the Zacks Consensus Estimate of a loss of $1.25, representing an earnings surprise of +32.00% [1] - The company posted revenues of $18.31 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 21.29% and showing an increase from $17.97 million in the same quarter last year [2] - Over the last four quarters, Enanta has surpassed consensus EPS estimates two times and topped revenue estimates twice [2] Stock Movement and Outlook - Enanta Pharmaceuticals shares have increased by approximately 20% since the beginning of the year, outperforming the S&P 500's gain of 8.6% [3] - The future performance of the stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$1.21 on revenues of $15.35 million, and for the current fiscal year, it is -$4.33 on revenues of $62.35 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Enanta belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Enanta's stock may also be influenced by the overall outlook for the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

[Overview and Highlights](index=1&type=section&id=Enanta%20Pharmaceuticals%20Reports%20Financial%20Results%20for%20its%20Fiscal%20Third%20Quarter%20Ended%20June%2030%2C%202025) [Management Commentary and Key Achievements](index=1&type=section&id=Management%20Commentary%20and%20Key%20Achievements) Enanta Pharmaceuticals reported steady pipeline progress in Q3 FY2025, completing zelicapavir's RSVHR trial enrollment and advancing immunology programs, backed by **$204.1 million** in cash - Completed enrollment in the RSVHR trial of zelicapavir, with topline data expected in **September 2025**[2](index=2&type=chunk)[5](index=5&type=chunk) - Advancing immunology programs with IND-enabling studies for oral KIT inhibitor EPS-1421 and expecting to select a lead candidate for the oral STAT6 inhibitor program in **H2 2025**[2](index=2&type=chunk)[5](index=5&type=chunk) - The company plans to announce a third immunology program later in **2025** to expand its inflammatory disease pipeline[2](index=2&type=chunk) - Operations are supported by cash and marketable securities totaling **$204.1 million** as of June 30, 2025, alongside ongoing retained royalties[5](index=5&type=chunk)[11](index=11&type=chunk) [Fiscal Third Quarter 2025 Financial Results](index=1&type=section&id=Fiscal%20Third%20Quarter%20Ended%20June%2030%2C%202025%20Financial%20Results) [Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) Enanta reported Q3 FY2025 total revenue of **$18.3 million**, a slight increase, with reduced R&D and G&A expenses leading to a narrowed net loss of **$18.3 million** Q3 FY2025 vs Q3 FY2024 Financial Performance (in millions, except per share data) | Metric | Q3 2025 | Q3 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $18.3 | $18.0 | +1.7% | | **R&D Expenses** | $27.2 | $28.7 | -5.2% | | **G&A Expenses** | $10.0 | $13.4 | -25.4% | | **Net Loss** | $(18.3) | $(22.7) | Narrowed | | **Loss Per Share** | $(0.85) | $(1.07) | Narrowed | - Revenue primarily consisted of royalties from worldwide net sales of AbbVie's HCV regimen MAVYRET®/MAVIRET®[3](index=3&type=chunk) - The decrease in R&D expenses was primarily due to the timing of clinical trials in the RSV programs[6](index=6&type=chunk) - The decrease in G&A expenses was mainly due to lower legal expenses related to the patent infringement lawsuit against Pfizer[7](index=7&type=chunk) [Financial Position and Outlook](index=2&type=section&id=Financial%20Position%20and%20Outlook) As of June 30, 2025, Enanta held **$204.1 million** in cash and marketable securities, projected to fund operations into fiscal year 2028 with future royalties - Cash, cash equivalents, and short-term marketable securities totaled **$204.1 million** at June 30, 2025[11](index=11&type=chunk) - The company expects its current cash position and future royalties to be sufficient to meet anticipated cash requirements into **fiscal year 2028**[11](index=11&type=chunk) - The company received a federal income tax refund of **$33.8 million** in **April 2025**[9](index=9&type=chunk) [Pipeline and Corporate Updates](index=2&type=section&id=Pipeline%20and%20Corporate%20Updates) [Virology Program](index=2&type=section&id=Virology%20Program) Enanta's virology pipeline focuses on oral antiviral treatments for RSV, including zelicapavir and EDP-323, with key progress in clinical trials and partnership evaluations [Zelicapavir (N-protein inhibitor)](index=2&type=section&id=Zelicapavir%20%28N-protein%20inhibitor%29) - Enrollment is complete with **186 patients** in the RSVHR Phase 2b study in high-risk adults[12](index=12&type=chunk) - Topline data from the RSVHR study is on track to be reported in **September 2025**[12](index=12&type=chunk) - Positive Phase 2 data in pediatric patients were presented at the ESPID 2025 Conference, highlighting shortened time to viral load negativity[12](index=12&type=chunk)[13](index=13&type=chunk) [EDP-323 (L-protein inhibitor)](index=3&type=section&id=EDP-323%20%28L-protein%20inhibitor%29) - EDP-323 is a potent, oral RSV L-protein inhibitor, suitable for monotherapy or combination use with agents like zelicapavir[16](index=16&type=chunk) - New data from a Phase 2a study were presented at the ESCMID Global 2025 Conference, highlighting reduced respiratory mucus production[16](index=16&type=chunk) [Immunology Program](index=3&type=section&id=Immunology%20Program) Enanta's immunology pipeline focuses on oral inhibitors for inflammatory diseases, with IND-enabling studies for EPS-1421 and a STAT6 inhibitor candidate selection planned for **H2 2025** [EPS-1421 (KIT inhibitor)](index=3&type=section&id=EPS-1421%20%28KIT%20inhibitor%29) - IND-enabling studies and scale-up activities are ongoing for EPS-1421, a novel oral KIT inhibitor[16](index=16&type=chunk) - EPS-1421 is being developed for chronic spontaneous urticaria and other mast cell-driven diseases[16](index=16&type=chunk) [STAT6 Inhibitor Program](index=3&type=section&id=STAT6%20Inhibitor%20Program) - Enanta is on track to select a STAT6 inhibitor development candidate in **H2 2025**[16](index=16&type=chunk) - Preclinical data show prototype oral STAT6 inhibitors exhibit potent nanomolar activity and high selectivity[16](index=16&type=chunk) [Pipeline Expansion](index=3&type=section&id=Pipeline%20Expansion) - Enanta plans to expand its immunology pipeline by introducing a third program in **2025**[16](index=16&type=chunk) [Corporate Developments](index=3&type=section&id=Corporate%20Developments) Corporate updates include AbbVie's FDA approval for an expanded MAVYRET® indication and Enanta's plan to issue Q4 and year-end results on **November 17, 2025** - Partner AbbVie received FDA approval for an expanded indication for MAVYRET® to treat acute HCV[16](index=16&type=chunk) - Enanta plans to issue its fiscal fourth quarter and year-end financial results on **November 17, 2025**[16](index=16&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement details financial performance for the three and nine months ended June 30, 2025, showing **$18.3 million** revenue and **$18.3 million** net loss for the quarter Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Nine Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue** | $18,314 | $17,971 | $50,199 | $53,028 | | **Total operating expenses** | $37,207 | $42,156 | $117,162 | $144,865 | | **Loss from operations** | $(18,893) | $(24,185) | $(66,963) | $(91,837) | | **Net loss** | $(18,255) | $(22,658) | $(63,189) | $(87,222) | | **Net loss per share, Basic & Diluted** | $(0.85) | $(1.07) | $(2.96) | $(4.12) | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet presents Enanta's financial position as of June 30, 2025, with total assets at **$301.0 million** and total stockholders' equity at **$79.3 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents & marketable securities** | $204,111 | $248,186 | | **Total current assets** | $222,708 | $299,852 | | **Total assets** | $301,029 | $376,652 | | **Total current liabilities** | $44,549 | $57,535 | | **Total liabilities** | $221,750 | $247,838 | | **Total stockholders' equity** | $79,279 | $128,814 |

Summary of Enanta Pharmaceuticals Conference Call Company Overview - **Company**: Enanta Pharmaceuticals - **Focus**: Initially concentrated on virology, particularly hepatitis C, and has since expanded into immunology and respiratory viruses, with a significant focus on RSV (Respiratory Syncytial Virus) and COVID-19 [6][7] Key Points and Arguments Company Strategy and Financials - Enanta has transitioned from a strong focus on virology to include immunology, aiming to broaden its therapeutic reach [6] - The company reported a cash balance of approximately $193 million, excluding a $33 million tax refund received in April [7][90] - The cash runway is projected to extend into fiscal 2028, supporting ongoing clinical studies without relying on RSV partnerships [90][91] RSV Therapeutics Development - Enanta aims to develop the first-ever therapeutic for RSV, differentiating its approach by targeting viral replication rather than viral entry [12][20] - The company is developing two main antiviral candidates for RSV: - **Zelicapavir**: An N protein inhibitor currently in Phase 2 trials, showing promising results in reducing viral load and symptoms in high-risk patients [22][25] - **EDP-323**: An L protein inhibitor also in Phase 2 development, demonstrating significant viral load reduction and rapid onset of action [45][49][51] - The upcoming Phase 2 study results for high-risk adults are expected to provide critical data for future development [34][44] Market Opportunity and Competitive Landscape - The RSV market is characterized by a lack of approved therapeutics, presenting a significant unmet need [56] - Previous attempts at developing fusion inhibitors for RSV have failed, indicating a shift in focus towards replication inhibitors as a more viable therapeutic option [56][58] - Enanta's strategy includes exploring partnerships for its RSV assets, with indications of interest from pharmaceutical companies [55][56] Immunology Programs - Enanta is expanding into immunology with a focus on KIT inhibition and STAT6 inhibition, targeting conditions like chronic urticaria and other allergic diseases [62][73] - The company aims to leverage its medicinal chemistry expertise to develop small molecule therapies that can outperform existing monoclonal antibodies [68][70] Financial Performance and Royalties - Enanta continues to receive royalties from AbbVie’s hepatitis C drug MAVERIT, contributing to its financial stability [83][88] - The company has monetized part of its royalty stream, which will revert to 100% ownership in 2032, providing a steady cash flow [88][89] Additional Important Information - Enanta is actively working on developing observer-reported outcome tools for pediatric studies to capture symptom data effectively [32] - The company is focused on ensuring safety and tolerability in its pediatric studies, particularly given the vulnerable patient population [30][29] - The management team emphasizes the importance of timely treatment for acute respiratory infections, highlighting the need for rapid-acting antiviral therapies [51] This summary encapsulates the key discussions and insights from the conference call, providing a comprehensive overview of Enanta Pharmaceuticals' current strategies, developments, and market positioning.

Financial Status - Enanta Pharmaceuticals reported a strong balance sheet with $193.4 million in cash as of March 31, 2025[6] - The company is leveraging ongoing royalties to support its robust pipeline[6] Respiratory Syncytial Virus (RSV) - Zelicapavir (EDP-938) - Zelicapavir is the only N-inhibitor in clinical development for RSV[17] - A Phase 2 pediatric study showed a viral load decline of 1.18 log at Day 5 in a prespecified subset of patients[25] - A Phase 2 pediatric study showed a viral load decline of 1.4 log at the end of treatment in Part 2[30] - EDP-323, an RSV L-protein inhibitor, demonstrated an 85-87% reduction in viral load AUC in a human challenge model[42] Immunology - KIT Inhibitor (EPS-1421) - EPS-1421 inhibits KIT with nanomolar potency in both binding and cellular assays[63] - EPS-1421 exhibits greater than 500-fold selectivity for KIT over other KIT family members[68] - In mice, EPS-1421 inhibits SCF-mediated histamine release with an EC50 (free drug) of 0.25nM[65] Immunology - STAT6 Inhibitor - Prototype STAT6 inhibitors exhibit nanomolar inhibition in biochemical and cellular assays[84] - Prototype STAT6 inhibitor demonstrates good selectivity, with greater than 1000x biochemical selectivity for STAT6 over other STATs[88] - Prototype STAT6 oral inhibitor results in complete inhibition of pSTAT6 in a mouse model[93]

Virology - Respiratory Syncytial Virus (RSV) - Zelicapavir (EDP-938) is the only N-inhibitor in clinical development for RSV, with Phase 2 pediatric study complete and Phase 2 high-risk adult study ongoing[17, 6] - In a Phase 2 pediatric study, zelicapavir showed a viral load decline of 0.88 log at Day 3 and 1.18 log at Day 5 in the prespecified mITT-3 population[25] - EDP-323, an RSV L-protein inhibitor, demonstrated 85-87% reduction in viral load AUC in a human challenge model[42] - A Phase 2 high-risk adult study is designed to show a clinically meaningful reduction in symptom duration of at least ~1 day with Zelicapavir[37] Immunology - The company is developing a KIT inhibitor for mast cell driven diseases like Chronic Spontaneous Urticaria (CSU) and a STAT6 inhibitor for type 2 immune diseases like atopic dermatitis[6] - EPS-1421, a KIT inhibitor development candidate, inhibits KIT with nanomolar potency and demonstrates sub-nanomolar activity in vivo[63] - Prototype STAT6 inhibitors inhibit STAT6 with nanomolar potency and are highly selective for STAT6 versus other STATs[79] - Prototype STAT6 oral inhibitor results in complete inhibition of pSTAT6 in a mouse model[89] Financial Status - The company had $193.4 million in cash as of March 31, 2025[6] Business Development - The company plans to pursue partnerships for zelicapavir and/or EDP-323[102]