Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2026
Key Terms
pharmacokinetics medical
pharmacodynamics medical
gpcr technical
- Dosing Initiated in LOTUS, a Phase 2b Pediatric Trial of Zelicapavir; Topline Data Expected in 2027
- On Track to Initiate RESOLVE, a Registrational Phase 2b/3 High-Risk Adult Trial of Zelicapavir in 4Q 2026; Topline Phase 2b Data Expected in 2027
- On Track to Report Topline Data from a Phase 1 Trial of EDP-978, an Oral, Once-Daily KIT Inhibitor in Development for the Treatment of Urticaria, in 4Q 2026
- On Track to File an IND for EPS-3903, an Oral, Once-Daily STAT6 Inhibitor and to Select an MRGPRX2 Development Candidate, in 2H 2026
-
Cash and Marketable Securities Totaling
$211.5 Million
“During the quarter, we continued to build momentum across both our RSV and immunology programs,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta. “Dosing began in LOTUS, our Phase 2b trial of zelicapavir in pediatric patients with RSV in
Fiscal Third Quarter Ended June 30, 2026 Financial Results
Total revenue for the three months ended June 30, 2026 was
A portion (
Research and development expenses totaled
General and administrative expenses totaled
Interest and investment income, net, totaled
Enanta recorded an income tax expense of less than
Net loss for the three months ended June 30, 2026 was
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled
Virology
Enanta’s virology pipeline includes the leading portfolio of RSV treatments in clinical development, consisting of zelicapavir, a once-daily N-protein inhibitor, and EDP-323, a once-daily L-protein inhibitor, both of which received Fast Track designation from the
- Dosing began in LOTUS, a Phase 2b study of zelicapavir in pediatric patients with RSV. LOTUS will evaluate zelicapavir in approximately 150 hospitalized and non-hospitalized children aged 28 days to 36 months who test positive for RSV and have experienced symptoms for up to 72 hours. Conducted in collaboration with the Penta Foundation and the AMS-PHPT Research Unit at Chiang Mai University, LOTUS is designed to evaluate the efficacy, safety, and antiviral activity of zelicapavir, with topline data expected in 2027.
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In June, Enanta announced its advancement of zelicapavir into registrational development, following an End-of-Phase 2 meeting with the FDA. Advancement into registrational development through a single Phase 2b/3 trial further highlights zelicapavir’s potential to become the first approved antiviral therapy for RSV and supports Enanta's continued leadership in RSV drug development.
- RESOLVE, the registrational Phase 2b/3 trial of zelicapavir in high-risk adults with RSV is on track to initiate in the fourth quarter of 2026. RESOLVE will enroll adults with RSV who are at high risk of severe disease, including patients aged 75 years or older and those with COPD or congestive heart failure. The Phase 2b portion of RESOLVE is designed to confirm the treatment effect observed in the prior RSVHR study, which demonstrated a clinically meaningful benefit in this high-risk adult population. Topline Phase 2b data from RESOLVE is expected in 2027.
-
Enanta presented data on zelicapavir at the American Thoracic Society (ATS) International Conference 2026 which was held May 15-20, 2026, in
Orlando, Florida and at the European Society of Clinical Microbiology & Infectious Diseases (ESCMID) Global Conference 2026 which was held April 17-21, 2026, inMunich, Germany . The posters and presentations are available on the Company’s website here.
- Enanta’s second RSV candidate, EDP-323, can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. Previously, the Company reported positive results from a Phase 2a challenge study of healthy adults infected with RSV, in which treatment with EDP-323 achieved highly statistically significant reductions in both viral load and clinical symptoms compared to placebo.
Immunology
Enanta’s immunology pipeline is focused on designing and developing highly potent and selective oral inhibitors for the treatment of inflammatory diseases, by targeting key drivers of the type 2 immune response.
- Enanta’s lead immunology program, EDP-978, is a potent and selective once-daily oral KIT inhibitor in development for the treatment of chronic urticaria and potentially other mast cell-mediated diseases. In April, the Company announced that the first participant was dosed in a randomized, double-blind, placebo-controlled, first-in-human Phase 1 clinical trial. The trial is expected to enroll approximately 98 healthy adult volunteers ranging in age from 18 to 65 years old to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics, including serum tryptase, of EDP-978. The trial includes a single ascending dose phase, with a two-part food-effect cohort, and a multiple ascending dose phase with a 14-day treatment period. The Company expects to report topline data from the trial in the fourth quarter of 2026.
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Enanta’s second immunology program, EPS-3903, is a novel, potent and selective oral STAT6 inhibitor, in development for the treatment of atopic dermatitis and other diseases currently treated by dupilumab. The Company is currently performing scale-up and IND-enabling activities and is targeting an IND filing in the second half of 2026.
-
Enanta presented posters highlighting data on EPS-3903 at the ATS International Conference 2026 which was held May 15-20, 2026, in
Orlando, Florida and at the American Association of Immunology Conference (Immunology 2026™) which was held April 15-19, 2026, inBoston, Massachusetts . The posters are available on the Company’s website here.
-
Enanta presented posters highlighting data on EPS-3903 at the ATS International Conference 2026 which was held May 15-20, 2026, in
- Enanta’s third immunology program targets MRGPRX2, a non-canonical G-Protein-Coupled-Receptor (GPCR) expressed predominantly on mast cells, as well as peripheral neurons. Inhibiting MRGPRX2 may have potential to address multiple mast-cell driven diseases, as well as having potential in migraine. Currently, the Company is evaluating multiple compounds in preclinical studies and expects to select a development candidate in the second half of 2026.
Corporate
- In June, Enanta announced that its partner AbbVie received European Commission approval of MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and older. MAVIRET is now the only treatment approved in the European Union for both acute and chronic HCV infection. Glecaprevir, one of the two direct-acting antivirals in MAVIRET, was discovered by Enanta and is a source of ongoing royalty revenue for the Company.
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In June,
the United States Court of Appeals for the Federal Circuit affirmed the summary judgment decision of the United States District Court for the District ofMassachusetts in the Company’s suit against Pfizer Inc. and ruled that the claims ofU.S . Patent No. 11,358,953 were invalid. In July, the Company filed a combined petition for panel or en banc rehearing of the Federal Circuit’s decision. A hearing for the patent infringement action against Pfizer in the Unified Patent Court (UPC) of the European Union, and Pfizer’s counterclaim for revocation, has been scheduled for September 29, 2026. Enanta expects a decision from the UPC within weeks after the hearing. - Enanta plans to issue its fiscal fourth quarter financial results press release on November 16, 2026.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for viral infections and immunological diseases. In virology, Enanta’s clinical programs are focused on the development of first-in-disease and best-in-disease treatments for respiratory syncytial virus (RSV). The Company’s immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, with KIT, STAT6 and MRGPRX2 inhibition.
Glecaprevir, a protease inhibitor discovered by Enanta, is part of the only treatment approved for curing both acute and chronic hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information.
Forward-Looking Statements
This press release contains forward-looking statements, including statements with respect to the timeline and prospects for advancement of Enanta’s clinical programs in RSV and KIT inhibition and its preclinical immunology programs, including its programs targeting STAT6 and MRGPRX2 inhibition. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to vaccines and competitive treatments for RSV; the discovery and development risks of Enanta’s programs in virology and immunology; Enanta’s limited clinical development experience; Enanta’s ability to partner its RSV or other programs; Enanta’s need to attract and retain senior management and key research and development personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; the outcome of the Federal Circuit rehearing petition and the Unified Patent Court proceedings related to Enanta’s patent claim against Pfizer; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year-ended September 30, 2025, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
Tables to Follow
| ENANTA PHARMACEUTICALS, INC. | |||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
UNAUDITED |
|||||||||||||||
(in thousands, except per share amounts) |
|||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
| Revenue | $ |
14,359 |
|
$ |
18,314 |
|
$ |
50,133 |
|
$ |
50,199 |
|
|||
| Operating expenses | |||||||||||||||
| Research and development |
|
22,126 |
|
|
27,210 |
|
|
62,428 |
|
|
82,931 |
|
|||
| General and administrative |
|
9,469 |
|
|
9,997 |
|
|
28,046 |
|
|
34,231 |
|
|||
| Total operating expenses |
|
31,595 |
|
|
37,207 |
|
|
90,474 |
|
|
117,162 |
|
|||
| Loss from operations |
|
(17,236 |
) |
|
(18,893 |
) |
|
(40,341 |
) |
|
(66,963 |
) |
|||
| Interest expense |
|
(4,130 |
) |
|
(1,618 |
) |
|
(10,529 |
) |
|
(5,294 |
) |
|||
| Interest and investment income, net |
|
1,901 |
|
|
2,285 |
|
|
6,407 |
|
|
7,376 |
|
|||
| Loss before income taxes |
|
(19,465 |
) |
|
(18,226 |
) |
|
(44,463 |
) |
|
(64,881 |
) |
|||
| Income tax (expense) benefit |
|
(36 |
) |
|
(29 |
) |
|
(67 |
) |
|
1,692 |
|
|||
| Net loss | $ |
(19,501 |
) |
$ |
(18,255 |
) |
$ |
(44,530 |
) |
$ |
(63,189 |
) |
|||
| Net loss per share | |||||||||||||||
| Basic | $ |
(0.67 |
) |
$ |
(0.85 |
) |
$ |
(1.54 |
) |
$ |
(2.96 |
) |
|||
| Diluted | $ |
(0.67 |
) |
$ |
(0.85 |
) |
$ |
(1.54 |
) |
$ |
(2.96 |
) |
|||
| Weighted average common shares outstanding | |||||||||||||||
| Basic |
|
29,090 |
|
|
21,377 |
|
|
28,958 |
|
|
21,322 |
|
|||
| Diluted |
|
29,090 |
|
|
21,377 |
|
|
28,958 |
|
|
21,322 |
|
|||
| ENANTA PHARMACEUTICALS, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| UNAUDITED (in thousands) |
|||||||
June 30, |
September 30, |
||||||
|
2026 |
|
2025 |
||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ |
33,419 |
$ |
32,298 |
|||
| Short-term marketable securities |
|
156,087 |
|
156,566 |
|||
| Accounts receivable |
|
6,534 |
|
6,882 |
|||
| Prepaid expenses and other current assets |
|
7,579 |
|
8,590 |
|||
| Total current assets |
|
203,619 |
|
204,336 |
|||
| Long-term marketable securities |
|
21,987 |
|
— |
|||
| Property and equipment, net |
|
31,942 |
|
35,395 |
|||
| Operating lease, right-of-use assets |
|
35,852 |
|
37,549 |
|||
| Long-term restricted cash |
|
3,360 |
|
3,360 |
|||
| Other long-term assets |
|
110 |
|
92 |
|||
| Total assets | $ |
296,870 |
$ |
280,732 |
|||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ |
3,293 |
$ |
1,948 |
|||
| Accrued expenses and other current liabilities |
|
10,183 |
|
12,751 |
|||
| Liability related to the sale of future royalties |
|
36,784 |
|
30,710 |
|||
| Operating lease liabilities |
|
3,906 |
|
3,146 |
|||
| Total current liabilities |
|
54,166 |
|
48,555 |
|||
| Liability related to the sale of future royalties, net of current portion |
|
88,289 |
|
111,132 |
|||
| Operating lease liabilities, net of current portion |
|
51,750 |
|
54,757 |
|||
| Series 1 nonconvertible preferred stock |
|
1,311 |
|
1,311 |
|||
| Other long-term liabilities |
|
286 |
|
260 |
|||
| Total liabilities |
|
195,802 |
|
216,015 |
|||
| Total stockholders' equity |
|
101,068 |
|
64,717 |
|||
| Total liabilities and stockholders' equity | $ |
296,870 |
$ |
280,732 |
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20260810427925/en/
Media and Investors Contact:
Jennifer Viera
jviera@enanta.com
Source: Enanta Pharmaceuticals, Inc.