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]

[Executive Summary & Program Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Program%20Highlights) Enanta Pharmaceuticals reported progress across its virology and immunology pipelines for the fiscal second quarter of 2025, meeting target enrollment for the Phase 2 RSVHR study of zelicapavir and maintaining a strong cash position bolstered by a significant federal income tax refund - Met target enrollment of **180 patients** in RSVHR, a Phase 2 study of zelicapavir for high-risk adults with RSV, with topline data expected in late Q3 2025[2](index=2&type=chunk)[5](index=5&type=chunk) - Plans to select a lead development candidate for the oral STAT6 inhibitor program in the second half of 2025, targeting atopic dermatitis initially[3](index=3&type=chunk)[5](index=5&type=chunk) - IND-enabling studies are ongoing for EPS-1421, the lead candidate in the KIT inhibitor program for chronic spontaneous urticaria[3](index=3&type=chunk)[5](index=5&type=chunk) - Cash and marketable securities totaled **$193.4 million** at quarter-end, strengthened by a **$33.8 million** federal tax refund received in April 2025[5](index=5&type=chunk)[12](index=12&type=chunk) [Fiscal Second Quarter 2025 Financial Results](index=1&type=section&id=Fiscal%20Second%20Quarter%202025%20Financial%20Results) Enanta reported total revenue of **$14.9 million** and a net loss of **$22.6 million** for Q2 FY2025, an improvement from the prior year due to reduced operating expenses, maintaining a strong cash position expected to fund operations into fiscal 2028 Q2 FY2025 vs Q2 FY2024 Financial Summary | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $14.9 million | $17.1 million | -12.9% | | R&D Expenses | $28.1 million | $35.6 million | -21.1% | | G&A Expenses | $11.4 million | $14.2 million | -19.7% | | Net Loss | ($22.6 million) | ($31.2 million) | +27.6% (Loss narrowed) | | Net Loss per Share | ($1.06) | ($1.47) | +27.9% (Loss narrowed) | - Revenue consists of royalties from AbbVie's HCV regimen MAVYRET®/MAVIRET®, with **54.5%** of this royalty servicing debt from a **$200.0 million** royalty sale transaction with OMERS[4](index=4&type=chunk)[6](index=6&type=chunk) - The decrease in R&D expenses was primarily due to the timing of clinical trials in the RSV program[7](index=7&type=chunk) - The decrease in G&A expenses was mainly due to lower legal costs related to the patent infringement lawsuit against Pfizer[8](index=8&type=chunk) - Cash, cash equivalents, and marketable securities totaled **$193.4 million**, with a subsequent **$33.8 million** tax refund, the company expects to fund operations into fiscal 2028[12](index=12&type=chunk) [Pipeline and Program Updates](index=2&type=section&id=Pipeline%20and%20Program%20Updates) Enanta is advancing a dual-focused pipeline in virology and immunology, with two Phase 2 RSV candidates exploring partnership opportunities and immunology programs progressing towards lead candidate selection and IND-enabling studies [Virology](index=2&type=section&id=Virology) Enanta's virology efforts focus on its leading RSV portfolio, featuring two oral antiviral candidates, zelicapavir and EDP-323, both with Fast Track designation, for which the company is evaluating potential partnerships - **Zelicapavir (N-protein inhibitor):** Met target enrollment of **180 high-risk adult patients** in the Phase 2b RSVHR study, with topline data expected late in Q3 2025[16](index=16&type=chunk) - **EDP-323 (L-protein inhibitor):** Demonstrated highly statistically significant reductions in viral load and clinical symptoms in a human challenge study, usable as monotherapy or in combination[16](index=16&type=chunk) - Both zelicapavir and EDP-323 have received Fast Track designation from the U.S. FDA[16](index=16&type=chunk) - The company will evaluate potential partnership opportunities to further develop its RSV assets[14](index=14&type=chunk) [Immunology](index=3&type=section&id=Immunology) The immunology pipeline focuses on oral inhibitors for inflammatory diseases, with the lead KIT inhibitor EPS-1421 in IND-enabling studies and a STAT6 inhibitor program poised to select a development candidate in late 2025, alongside plans for a third program - **KIT Inhibitors:** The lead candidate, EPS-1421, is a potent and selective oral inhibitor of KIT, currently undergoing scale-up activities and IND-enabling studies[16](index=16&type=chunk) - **STAT6 Inhibitors:** The program targets the transcription factor for IL-4/IL-13 signaling, with prototypes showing nanomolar inhibition, high selectivity, and in vivo target engagement, and a development candidate selection planned for 2H 2025[16](index=16&type=chunk)[20](index=20&type=chunk) - Enanta plans to expand its immunology pipeline by introducing a third program in 2025[20](index=20&type=chunk) [Corporate Updates](index=4&type=section&id=Corporate%20Updates) Enanta received a **$33.8 million** federal income tax refund in April 2025 and is proceeding with its patent infringement lawsuit against Pfizer regarding Paxlovid™, having filed an opening brief in March 2025 - Received a **$33.8 million** federal income tax refund in April 2025[20](index=20&type=chunk) - Filed an opening brief with the U.S. Court of Appeals on March 21, 2025, in its patent infringement lawsuit against Pfizer concerning the COVID-19 antiviral, Paxlovid™[20](index=20&type=chunk) - The company plans to issue its fiscal third quarter 2025 financial results on August 11, 2025[20](index=20&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The unaudited condensed consolidated financial statements provide a comprehensive view of Enanta's financial position as of March 31, 2025, and its operational results for the three and six months then ended, detailing revenues, expenses, assets, liabilities, and stockholders' equity [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, Enanta reported revenues of **$14.9 million** and a net loss of **$22.6 million**, with both periods showing narrower losses compared to the prior year due to reduced operating expenses Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | Six Months Ended March 31, | | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue** | **$14,926** | **$17,054** | **$31,885** | **$35,057** | | Total operating expenses | $39,453 | $49,820 | $79,955 | $102,709 | | 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, diluted** | **($1.06)** | **($1.47)** | **($2.11)** | **($3.06)** | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Enanta reported total assets of **$323.0 million**, including **$193.4 million** in cash and marketable securities, with total liabilities of **$229.5 million** and total stockholders' equity of **$93.5 million** Condensed Consolidated Balance Sheet Highlights (Unaudited, in thousands) | | **March 31, 2025** | **September 30, 2024** | | :--- | :--- | :--- | | **Assets** | | | | Cash and marketable securities | $193,375 | $248,186 | | Total current assets | $242,860 | $299,852 | | **Total assets** | **$322,993** | **$376,652** | | **Liabilities and Equity** | | | | Liability related to sale of future royalties (Total) | $156,060 | $169,241 | | Total liabilities | $229,455 | $247,838 | | **Total stockholders' equity** | **$93,538** | **$128,814** |

分组1 - Profound Medical reported a quarterly loss of $0.36 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.29, and a decline from a loss of $0.26 per share a year ago, indicating an earnings surprise of -24.14% [1] - The company generated revenues of $2.62 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 24.03%, and showing an increase from $1.91 million in the same quarter last year [2] - Profound Medical shares have decreased by approximately 36% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] 分组2 - The earnings outlook for Profound Medical is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.27 on revenues of $4.2 million, and for the current fiscal year at -$1.06 on revenues of $19.04 million [7] - The Medical - Drugs industry, to which Profound Medical belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

分组1 - Ionis Pharmaceuticals reported a quarterly loss of $0.75 per share, better than the Zacks Consensus Estimate of a loss of $1.11, and improved from a loss of $0.98 per share a year ago, representing an earnings surprise of 32.43% [1] - The company posted revenues of $132 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.86%, and compared to year-ago revenues of $119 million [2] - Ionis Pharmaceuticals has surpassed consensus EPS estimates for four consecutive quarters [2] 分组2 - The stock has underperformed the market, losing about 14.7% since the beginning of the year, while the S&P 500 declined by 5.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.85 on revenues of $146.33 million, and for the current fiscal year, it is -$3.31 on revenues of $637.57 million [7] - The Zacks Industry Rank for Medical - Drugs is in the top 20% of over 250 Zacks industries, indicating a favorable outlook for the industry [8]

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q2 2022 Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants Jennifer Viera - Director of IR & Corporate Communications Jay Luly - President and CEO Paul Mellett - CFO Nathalie Adda - Consultant Tara Kieffer - SVP, New Product Strategy & Development Conference Call Participants Luke Herrmann - Robert W. Baird Brian Abrahams - RBC Capital Markets Swapnil Malekar - Piper Sandler Akash Tewari - Jefferies Roy Buchanan - JMP Securities Hannah Adeoye - ...

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 December 31, 2021 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 2834 04-3205099 (State or other jurisdiction of incorporation or organi ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $27.6 million, down from $31.7 million in the same period of 2021, entirely consisting of royalty revenue from AbbVie's HCV product sales of $427 million [27][28]. - Net loss for the quarter was $30.1 million, or a loss of $1.48 per diluted share, compared to a net loss of $8.3 million, or a loss of $0.41 per diluted share in Q1 2021 [33]. Business Line Data and Key Metrics Changes - Research and development expenses increased to $48.5 million from $36.7 million in the same period last year, primarily due to the timing of manufacturing for clinical studies [30]. - General and administrative expenses rose to $9.5 million from $7.4 million, attributed to increased headcount and compensation [31]. Market Data and Key Metrics Changes - AbbVie reported global HCV sales of $1.7 billion for calendar 2021 and guided to the same amount for 2022, indicating a flat year due to COVID-19 impacts [30][72]. Company Strategy and Development Direction - The company is focused on developing antiviral treatments for respiratory syncytial virus (RSV), COVID-19, and hepatitis B, with multiple clinical programs underway [5][22]. - Enanta aims to establish itself as a leader in the development of treatments for respiratory viruses, with a strong emphasis on high-risk patient populations for RSV and COVID-19 [16][20]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their antiviral candidates, particularly EDP-938 for RSV and EDP-235 for COVID-19, highlighting their robust clinical data and safety profiles [11][19]. - The company expects to report top-line data from the RSVP study of EDP-938 in the next quarter and plans to initiate a Phase 1 study for EDP-323, an RSV L-inhibitor, in the second half of the year [25][16]. Other Important Information - Enanta ended the quarter with $347.7 million in cash and marketable securities, which is expected to be sufficient for at least the next two years [33]. - The company is committed to evaluating internal and external opportunities for additional compounds to enhance its hepatitis B treatment regimen [24]. Q&A Session Summary Question: What are the competitive opportunities for EDP-235? - Management indicated that the Phase 1 study is about to begin and they plan to share safety and pharmacokinetic data in the first half of the year. They believe EDP-235 has advantages in terms of pharmacokinetics and tissue targeting [35][36]. Question: How severe are RSV symptoms this season compared to previous seasons? - Management noted that they have not observed any worsening of symptoms in current studies, and the median age of participants is expected to be around 50 [39][41]. Question: What is the strategy for the L-protein inhibitor? - The company plans to target high-risk populations for the L-protein inhibitor and is exploring various ways to position the drug in combination with other agents [46][48]. Question: How will the RSVP study inform future trials? - Management stated that the RSVP study will help de-risk future studies in high-risk populations, and they are focused on targeting pediatric and transplant patients [53][80]. Question: What is the outlook for Mavyret revenues? - The company expects AbbVie's guidance of $1.7 billion in 2022 to support ongoing royalty revenues, which will help sustain operations for at least the next two years [72][76].

Financial Data and Key Metrics Changes - For Q4 2021, total revenue was $23.6 million, consistent with the same period in 2020, primarily from royalty revenue on AbbVie's HCV product sales [19][20] - Research and development expenses increased to $48.9 million from $36.7 million year-over-year, attributed to the expansion of clinical trials [20] - Net loss for Q4 2021 was $24.6 million, or a loss of $1.22 per diluted share, compared to a net loss of $29.3 million, or a loss of $1.46 per diluted share in Q4 2020 [23] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs in hepatitis B, with EDP-514 showing significant antiviral activity in Phase 1 studies [5][7] - The respiratory virology portfolio includes EDP-938, which is in multiple Phase 2 studies, demonstrating robust clinical data [10][11] - Development of EDP-721 was discontinued due to safety observations, while the focus remains on EDP-514 for chronic HBV treatment [9] Market Data and Key Metrics Changes - AbbVie expects total HCV sales of approximately $1.7 billion for 2021, with treated patient volumes remaining suppressed compared to pre-COVID levels [19] - The company anticipates that the reemergence of RSV will facilitate enrollment in clinical studies during the Northern Hemisphere winter season [12] Company Strategy and Development Direction - The company aims to develop a functional cure for chronic hepatitis B patients, focusing on combination regimens involving EDP-514 [9][17] - A strategic decision was made to prioritize combination approaches for NASH FXR agonists through out-licensing, rather than continuing internal development [17] - The company is exploring external opportunities for additional mechanisms to enhance its HBV treatment strategy [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of EDP-235 as a best-in-class oral therapy for COVID-19, with plans to advance it into clinical trials in early 2022 [16][17] - The ongoing pandemic is expected to transition towards an endemic phase, where effective therapeutics will remain crucial [17] - Management acknowledged the challenges posed by the pandemic on patient recruitment and clinical trial designs, emphasizing the need for adaptive strategies [51] Other Important Information - The company ended the quarter with approximately $352.4 million in cash and marketable securities, sufficient to meet anticipated cash requirements for at least the next two years [24] - Fiscal 2022 guidance includes research and development expenses projected between $150 million to $170 million [24] Q&A Session Summary Question: Can you discuss the IND-enabling tox work for EDP-235? - Management confirmed completion of multi-week GLP tox studies, indicating a comfortable safety margin for predicted clinical doses [27] Question: Will you explore testing EDP-235 in combination with other classes? - Management noted that combinations could be considered based on the evolving nature of the pandemic and viral variants [29] Question: What is the potential for achieving a functional cure in hepatitis B with EDP-514? - Management believes that a core inhibitor plus a NUC would benefit from additional agents to enhance treatment efficacy [31] Question: How will you stratify patients in the RSV studies? - Management confirmed that viral load will be monitored, and analyses will include thresholds based on viral load at the time of dosing [38] Question: What are the plans for partnering EDP-235? - Management indicated that partnerships are likely but will depend on the progress of clinical trials and data generation [45] Question: How will you approach clinical development for EDP-235 given competition? - Management acknowledged the need for adaptive trial designs, potentially favoring non-inferiority studies depending on the patient population targeted [51]

E N A N T A Pharmaceuticals CREATING SMALL MOLECULE DRUGS FOR VIRAL INFECTIONS AND LIVER DISEASES Corporate Presentation September 13, 2021 Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our research and development programs, our business and the industry in which we operate. Any statements contained herein that are not statements of ...