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View the Factors and Risks We Describe in the Reports We Will File from Time to Time with the SEC After the Date of This Annual Report on Form 10-K

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View the Factors and Risks We Describe in the Reports We Will File from Time to Time with the SEC After the Date of This Annual Report on Form 10-K Creating small molecule drugs for viral infections and liver diseases 2020 ANNUAL REPORT January 12, 2021 TO OUR We made significant progress with our hepatitis B SHAREHOLDERS, virus (HBV) program this year by advancing I’d like to acknowledge EDP-514, our novel core inhibitor that disrupts the extraordinary times the assembly and replication of the virus at we experienced in 2020 multiple steps in the viral lifecycle. Based on during the COVID-19 our preclinical data, we believe EDP-514 has pandemic. Despite a best-in-class potential for the core inhibitor period of significant mechanism. In February, we announced positive upheaval and uncertainty, results from Part 1 of a Phase 1a/b clinical study the strength of our of EDP-514 in healthy subjects, which allowed employees allowed us to us to initiate Part 2 in chronic HBV patients maintain continuous business operations and rise treated with a nucleos(t)ide reverse transcriptase to the challenges the pandemic presented. We inhibitor, whom we refer to as NUC-suppressed were able not only to make meaningful progress patients. These encouraging data highlighted in our programs, but also to lay the groundwork positive safety and tolerability, as well as for a catalyst-driven 2021. pharmacokinetics suitable for once daily dosing, and supported moving to Part 2 of this Phase Looking at our wholly-owned pipeline, we 1a/1b study, which is now ongoing. Also, in our are evaluating EDP-938 in a broad clinical HBV program, in July, we initiated a Phase 1b development program for respiratory syncytial clinical study in chronic HBV-infected patients virus (RSV), a virus for which there is no with high viral load not currently on treatment, therapeutic option. Globally, there are an whom we refer to as viremic patients. We plan to estimated 33 million cases of RSV annually in have preliminary data for both HBV trials in the children less than five years of age, with about second quarter of 2021. Additionally, we recently 3 million hospitalized and up to approximately discovered a new drug candidate for HBV, EDP- 120,000 dying each year from complications 721, that could potentially be combined with associated with the infection. EDP-938 is the EDP-514 and a NUC to create an all-oral, triple only N-inhibitor in development, and our clinical regimen. A Phase 1 clinical trial with EDP-721 is program consists of three ongoing trials: RSVP, expected to start in mid-2021. RSVTx and RSVPEDs. Together, these studies are designed to evaluate the effect of EDP-938 in a The global pandemic strengthened our resolve range of pediatric and adult patient populations. to advance novel therapies for unmet needs, While the current season for RSV in the Northern and our core expertise in both virology and Hemisphere has not begun due to continuing respiratory diseases has positioned Enanta to COVID-19 mitigation measures, we will continue be part of the therapeutic solution for COVID-19 to add clinical sites around the globe to capture and other emerging respiratory viral threats. recruitment in the trials when and where the To that end, this year we added three new seasonal virus becomes prevalent again. Also, programs, one for SARS-CoV-2, one for human in the fourth quarter of 2020, we initiated RSVTx, metapneumovirus (hMPV), and an additional a Phase 2b study in adult hematopoietic cell new initiative for RSV. By focusing on these transplant recipients with acute RSV infection of viruses, combined with our ongoing clinical stage the upper respiratory tract. Further, we plan to development work in RSV, we are furthering initiate RSVPEDs, a Phase 2 study in hospitalized our position as one of only a few biotechnology and non-hospitalized pediatric patients with RSV, companies explicitly developing a broad portfolio in the first quarter of 2021. of respiratory virus treatments. Our hMPV program is a natural adjacency for us, securities at September 30, 2020. We earned as it is a virus similar to RSV. hMPV is a pathogen approximately $122 million in royalty revenue that causes upper and lower respiratory tract from AbbVie’s sales of MAVYRET®, which remains infections in young children and the elderly, as a leading treatment for hepatitis C virus (HCV). well as in immunocompromised patients and While our royalties were impacted by patient- those with COPD and asthma. We announced treated volumes of MAYVRET being below our hMPV discovery efforts in January, which pre-COVID levels, we are encouraged about the remain ongoing. long-term success of MAVYRET. The treatment has been remarkably impactful for patients, With the onset of COVID-19, we made the curing hundreds of thousands of people with decision early in 2020 to leverage our expertise HCV, and we expect it will continue to play a in direct-acting antiviral mechanisms to discover critical role in the treatment of the millions still new compounds to treat COVID-19, using a infected with the virus. combination of drug target screening and drug design. While we are encouraged with the To close, Enanta continues to build on its robust recent development of vaccines for COVID-19, pipeline, and I remain excited for our 2021 we believe there will remain a need for an oral catalysts. We look forward to continuing the treatment for those who become infected with momentum of developing meaningful new the SARS-CoV-2 virus. We are optimizing new treatments for patients across diseases with lead compounds for hMPV, SARS-CoV-2 and RSV high unmet need that are well suited for and hope to finalize additional clinical candidates small molecule drugs. I value the input and in two of these programs in 2021. encouragement of our shareholders and Board of Directors, as well as the dedication of our Turning to the remainder of our pipeline, we employees, and want to thank all of you for your advanced our programs for the treatment of commitment to Enanta. I look forward to updating non-alcoholic steatohepatitis (NASH) with fibrosis you throughout the coming year. by progressing EDP-305, our lead farnesoid X receptor (FXR) agonist, and EDP-297, our highly potent and targeted follow-on FXR agonist. In Sincerely, August, we began enrollment for ARGON-2, our Phase 2b, 72-week study of EDP-305 in approximately 340 patients, and in September we initiated our Phase 1, first-in-human clinical study of EDP-297. We expect to have EDP-297 Jay R. Luly, Ph.D. data in the second quarter of 2021, together President and Chief Executive Officer with an internal interim analysis at 12 weeks of treatment on a subset of patients in ARGON-2 around mid-year, which will enable us to prioritize both compounds and leverage opportunities for potential partnering and development of one or both of them in combinations with other mechanisms for NASH. Fiscally, Enanta remains in a strong position with over $419 million in cash and marketable UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2020 OR ☐ TRANSITION REPORTPURSUANT TO SECTION 13 OR 15(d)OFTHE 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 (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) 500 Arsenal Street Watertown, Massachusetts 02472 (617) 607-0800 (Address, including zip code, and telephone number, including area code, of registrantsprincipal executive offices) Securitiesregistered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.01 per share ENTA NASDAQ Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is awell-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is notrequired to file reports pursuanttoSection 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filedbySection 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was requiredtofile such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas requiredtosubmit such files): Yes ☒ No ☐ Indicate by check mark whether the registrant is alarge accelerated filer, an accelerated filer,anon-acceleratedfiler, smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer,accelerated filer,smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act: Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by checkmark whether the registrant has filed areport on and attestation to its managementsassessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.
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