UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 04-3205099 (State or other jurisdiction of incorporation or organization) 4 ...

Enanta Pharmaceuticals (ENTA) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $1.25. This compares to a loss of $1.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +32.00%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.04 per share when it actually produced a loss of $1.06, delivering a surprise of -1.92%.Over the last four quarters, ...

[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]

Summary of Enanta Pharmaceuticals (ENTA) 2025 Conference Call Company Overview - Enanta Pharmaceuticals is historically a virology infectious disease company and has recently expanded into immunology [2][3] Key Focus Areas Virology - Enanta is focusing on respiratory virology, particularly on the development of **zelicapavir**, an N protein inhibitor for treating RSV (Respiratory Syncytial Virus) [3][4] - Pediatric data was reported in December, showing safety and pharmacokinetics (PK) as primary objectives, with encouraging early data on a new observer-reported outcome tool called **Bresolve P** [4] - A high-risk adult study has been completed with 180 patients enrolled, focusing on symptomatic endpoints related to lower respiratory tract disease [5][6] - The primary objective is to demonstrate a clinically meaningful reduction in symptom duration, aiming for a reduction of about one day or more [7][8] - Enanta plans to move into a phase three study based on the effect size determined in the phase two proof of concept study [8][9] Immunology - Enanta has two announced programs in immunology: one targeting **wild type KIT** and the other focusing on **STAT6 inhibition** [9][10] - The development candidate for the KIT program is expected to enter IND (Investigational New Drug) enabling work soon [10] - The STAT6 program aims to develop an oral small molecule that could replicate the clinical benefits of Dupixent, which works through the IL-4 and IL-13 signaling pathway [11][12] - Early data shows good target engagement and anti-inflammatory profiles in preclinical models [13][14] Strategic Considerations - Enanta is considering partnerships to advance its RSV programs, with a focus on bringing forward two replication inhibitors with different mechanisms [21][22] - The company is aware of the challenges in demonstrating statistically significant benefits in viral kinetics and symptom reduction in RSV studies [18][48] - Historical data suggests that a one-day symptom improvement is clinically meaningful and aligns with expectations for respiratory drugs [24] Patient Population Insights - The current study focuses on high-risk adults aged 65 and older, with 80% of participants having significant comorbidities [35][36] - The enrollment strategy has shifted to capture patients earlier in their symptom onset to improve the chances of demonstrating drug efficacy [30][41] Data and Efficacy Expectations - The company anticipates that the phase two study may not achieve statistical significance with a one-day benefit but aims to gather data to inform a larger phase three study [48][51] - Viral load reductions are expected to be compared to placebo, with previous studies showing about a log reduction at the end of treatment [51][52] Conclusion - Enanta Pharmaceuticals is actively advancing its pipeline in both virology and immunology, with a strategic focus on partnerships and data-driven decision-making to navigate the complexities of drug development in challenging therapeutic areas like RSV and asthma [22][78]

Core Viewpoint - Enanta Pharmaceuticals (ENTA) has seen a 5.1% increase in share price over the past four weeks, closing at $5.18, with a mean price target of $15 indicating a potential upside of 189.6% according to Wall Street analysts [1][11]. Price Targets and Analyst Estimates - The mean estimate consists of six short-term price targets with a standard deviation of $7.27, indicating variability among analysts; the lowest estimate suggests a 3.5% decline, while the highest predicts a 344% increase to $23 [2][9]. - Analysts' price targets are often viewed with skepticism due to historical inaccuracies, as they may not reliably indicate future stock price movements [7][10]. - A low standard deviation in price targets suggests a strong consensus among analysts regarding the stock's price direction, which can serve as a starting point for further research [9]. Earnings Estimates and Analyst Sentiment - Analysts have shown strong agreement in revising ENTA's earnings estimates upward, which correlates with potential stock price increases; the Zacks Consensus Estimate has risen by 26.2% over the past 30 days [4][12]. - ENTA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a solid potential upside [13].

PART I. Unaudited Financial Information [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The company reported net losses of $22.6 million and $44.9 million for the three and six months ended March 31, 2025, respectively, with total assets at $323.0 million and $30.3 million in cash used in operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $323.0 million as of March 31, 2025, from $376.7 million, primarily due to reduced marketable securities, while liabilities and equity also declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,213 | $37,233 | | Short-term marketable securities | $133,162 | $210,953 | | **Total current assets** | **$242,860** | **$299,852** | | **Total assets** | **$322,993** | **$376,652** | | **Liabilities & Equity** | | | | Total current liabilities | $45,947 | $57,535 | | Liability related to the sale of future royalties (non-current) | $125,379 | $134,779 | | **Total liabilities** | **$229,455** | **$247,838** | | **Total stockholders' equity** | **$93,538** | **$128,814** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for the three months ended March 31, 2025, narrowed to $22.6 million on $14.9 million revenue, primarily due to lower operating expenses, with the six-month net loss also improving to $44.9 million Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | Six Months Ended Mar 31, 2025 | Six Months Ended Mar 31, 2024 | | :--- | :--- | :--- | :--- | :--- | | Royalty revenue | $14,926 | $17,054 | $31,885 | $35,057 | | Research and development | $28,065 | $35,585 | $55,721 | $71,956 | | General and administrative | $11,388 | $14,235 | $24,234 | $30,753 | | Loss from operations | $(24,527) | $(32,766) | $(48,070) | $(67,652) | | **Net loss** | **$(22,644)** | **$(31,157)** | **$(44,934)** | **$(64,564)** | | Net loss per share, basic and diluted | $(1.06) | $(1.47) | $(2.11) | $(3.06) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to $30.3 million for the six months ended March 31, 2025, with overall cash increasing by $22.4 million due to investing activities Summary of Cash Flows (in thousands) | Activity | Six Months Ended Mar 31, 2025 | Six Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,289) | $(53,589) | | Net cash provided by investing activities | $64,534 | $45,507 | | Net cash used in financing activities | $(11,873) | $(13,764) | | **Net increase (decrease) in cash** | **$22,372** | **$(21,846)** | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The notes detail the company's biotechnology focus, primary revenue from AbbVie, sufficient cash for 12 months, ongoing patent litigation against Pfizer, and accounting for a $200 million royalty sale agreement - The company believes its cash, cash equivalents, and short-term marketable securities of **$193.4 million** as of March 31, 2025, are sufficient to fund operations for at least **12 months** from the financial statement issuance date[28](index=28&type=chunk) - In April 2023, the company sold **54.5%** of future royalty payments on MAVYRET/MAVIRET to an affiliate of OMERS for a **$200 million** upfront payment. The proceeds are recorded as a liability and amortized over the life of the agreement[39](index=39&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) - Enanta is appealing a December 2024 District Court summary judgment decision that ruled its '953 Patent, related to its infringement suit against Pfizer's Paxlovid, was invalid. The appeal was filed in February 2025[60](index=60&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's virology and immunology pipeline, noting decreased revenue from AbbVie but significantly lower operating expenses, and projects funding into fiscal 2028 with current cash and an anticipated tax refund [Overview and Pipeline](index=18&type=section&id=Overview%20and%20Pipeline) Enanta is a biotechnology company focused on small molecule drugs for virology and immunology, with primary revenue from AbbVie royalties and a pipeline including RSV, COVID-19, and immunology programs - The company's active development programs in virology are focused on respiratory syncytial virus (RSV), with two clinical-stage candidates: zelicapavir and EDP-323[67](index=67&type=chunk)[73](index=73&type=chunk) - In immunology, the company is developing oral small molecule inhibitors, with initial targets being KIT for chronic spontaneous urticaria (CSU) and STAT6 for atopic dermatitis (AD)[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) Product Development Pipeline Summary | Program | Disease | Target | Stage | | :--- | :--- | :--- | :--- | | **Virology** | | | | | Zelicapavir | RSV | N-Protein | Phase 2 (Pediatrics & High-Risk Adults) | | EDP-323 | RSV | L-Protein | Phase 2 (challenge study completed) | | EDP-235 | COVID-19 | 3CL Protease | Phase 2 (seeking collaboration) | | **Immunology** | | | | | EPS-1421 | CSU | KIT | Preclinical (IND-enabling studies) | | STAT6 Inhibitor | Atopic Dermatitis | STAT6 | Discovery (lead optimization) | [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Net losses narrowed for both the three- and six-month periods ended March 31, 2025, driven by significant reductions in R&D and general and administrative expenses, despite lower royalty revenue [Comparison of the Three Months Ended March 31, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024) Revenue decreased to $14.9 million for the three months ended March 31, 2025, but a significant reduction in R&D and general and administrative expenses led to a net loss improvement to $22.6 million - Revenue decreased by **$2.1 million** year-over-year to **$14.9 million** due to lower reported HCV sales by AbbVie[99](index=99&type=chunk) R&D Expense Breakdown - Three Months Ended March 31 (in thousands) | Program | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Total Virology | $18,106 | $26,545 | $(8,439) | | Total Immunology | $7,293 | $4,673 | $2,620 | | **Total R&D** | **$28,065** | **$35,585** | **$(7,520)** | - General and administrative expenses decreased by **$2.8 million** year-over-year, primarily due to a decrease in legal expenses related to the patent infringement suit against Pfizer[107](index=107&type=chunk) [Comparison of the Six Months Ended March 31, 2025 and 2024](index=28&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20March%2031%2C%202025%20and%202024) Revenue decreased to $31.9 million for the six months ended March 31, 2025, but a substantial reduction in R&D and general and administrative expenses resulted in a net loss of $44.9 million - Revenue decreased by **$3.2 million** year-over-year to **$31.9 million** due to lower reported HCV sales by AbbVie[112](index=112&type=chunk) R&D Expense Breakdown - Six Months Ended March 31 (in thousands) | Program | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Total Virology | $36,699 | $54,156 | $(17,457) | | Total Immunology | $13,838 | $8,695 | $5,143 | | **Total R&D** | **$55,721** | **$71,956** | **$(16,235)** | - General and administrative expenses decreased by **$6.5 million** year-over-year, primarily due to lower legal expenses related to the Pfizer patent suit[118](index=118&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$193.4 million** in cash and marketable securities, expecting these resources plus a **$33.8 million** tax refund to fund operations into fiscal 2028 - The company expects its existing cash, marketable securities, retained royalties, and a **$33.8 million** tax refund (received in April 2025) will fund operations into fiscal 2028[126](index=126&type=chunk)[86](index=86&type=chunk) Cash Flow Summary - Six Months Ended March 31 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Cash used in Operating activities | $(30,289) | $(53,589) | | Cash provided by Investing activities | $64,534 | $45,507 | | Cash used in Financing activities | $(11,873) | $(13,764) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes occurred in the company's market risk disclosures during the six months ended March 31, 2025, compared to the prior fiscal year's annual report - There were no material changes to the company's market risk disclosures during the six months ended March 31, 2025[140](index=140&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[141](index=141&type=chunk) - No changes occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[142](index=142&type=chunk) PART II. Other Information [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is appealing a December 2024 District Court ruling that invalidated its patent claims in an infringement lawsuit against Pfizer regarding Paxlovid, filed in June 2022 - Enanta filed a lawsuit against Pfizer in June 2022 for infringement of its U.S. Patent No. 11,358,953 related to Pfizer's COVID-19 antiviral, Paxlovid[60](index=60&type=chunk) - On December 23, 2024, the District Court ruled that the asserted patent claims were invalid. Enanta filed an appeal with the Federal Circuit on February 3, 2025, and the outcome is pending[60](index=60&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred to the company's risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended September 30, 2024 - No material changes to the company's risk factors occurred during the quarter ended March 31, 2025[145](index=145&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[146](index=146&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and certifications by the CEO and CFO - The report includes exhibits such as CEO and CFO certifications (31.1, 31.2, 32.1) and XBRL data files (101, 104)[147](index=147&type=chunk)

Group 1 - Enanta Pharmaceuticals reported a quarterly loss of $1.06 per share, slightly worse than the Zacks Consensus Estimate of a loss of $1.04, but an improvement from a loss of $1.47 per share a year ago, indicating an earnings surprise of -1.92% [1] - The company posted revenues of $14.93 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 8.71%, and down from $17.05 million in the same quarter last year [2] - Enanta Pharmaceuticals shares have declined approximately 8.4% since the beginning of the year, compared to a decline of 3.8% for the S&P 500 [3] Group 2 - The earnings outlook for Enanta Pharmaceuticals is mixed, with the current consensus EPS estimate for the upcoming quarter at -$1.15 on revenues of $16.34 million, and for the current fiscal year at -$3.90 on revenues of $64.44 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 27% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] - Plus Therapeutics, another company in the same industry, is expected to report a quarterly loss of $0.17 per share, reflecting a year-over-year change of +77.3%, with revenues projected to be $1.85 million, up 10.1% from the previous year [9]