10-Q
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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, 2026

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)

 

(I.R.S. Employer

Identification Number)

 

4 Kingsbury Avenue

Watertown, Massachusetts

 

02472

(Address of principal executive offices)

 

(Zip Code)

 

(Registrant’s telephone number, including area code:) (617) 607-0800

 

Securities registered 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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 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 required to file 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 registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of August 7, 2026, the registrant had 29,125,402 shares of common stock, $0.01 par value per share, outstanding.

 

 

 


Table of Contents

 

Page

PART I.

UNAUDITED FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations

4

Condensed Consolidated Statements of Comprehensive Loss

5

 

Condensed Consolidated Statements of Stockholders' Equity

6

Condensed Consolidated Statements of Cash Flows

8

Notes to Condensed Consolidated Financial Statements (unaudited)

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

29

Item 1A.

Risk Factors

29

Item 5.

Other Information

29

Item 6.

Exhibits

30

Signatures

31

 

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potentially,” “predict,” “project,” “should,” “will” or the negative of these terms or other similar expressions. We caution you that the foregoing list may not encompass all of the forward-looking statements made in this Quarterly Report.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2025 and as updated in Item 1A herein.

2


PART I—UNAUDITED FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except per share data)

 

 

 

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

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common stock; $0.01 par value per share, 100,000 shares authorized;
  
29,120 and 21,387 shares issued and outstanding at June 30, 2026
  and September 30, 2025 respectively

 

 

291

 

 

 

214

 

Additional paid-in capital

 

 

551,163

 

 

 

469,771

 

Accumulated other comprehensive loss

 

 

(927

)

 

 

(339

)

Accumulated deficit

 

 

(449,459

)

 

 

(404,929

)

Total stockholders' equity

 

 

101,068

 

 

 

64,717

 

Total liabilities and stockholders' equity

 

$

296,870

 

 

$

280,732

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

14,359

 

 

$

18,314

 

 

$

50,133

 

 

$

50,199

 

Total 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

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(4,130

)

 

 

(1,618

)

 

 

(10,529

)

 

 

(5,294

)

Interest and investment income, net

 

 

1,901

 

 

 

2,285

 

 

 

6,407

 

 

 

7,376

 

Total other (expense) income, net

 

 

(2,229

)

 

 

667

 

 

 

(4,122

)

 

 

2,082

 

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 and diluted

 

$

(0.67

)

 

$

(0.85

)

 

$

(1.54

)

 

$

(2.96

)

Weighted average common shares outstanding, basic and
   diluted

 

 

29,090

 

 

 

21,377

 

 

 

28,958

 

 

 

21,322

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Net loss

 

$

(19,501

)

 

$

(18,255

)

 

$

(44,530

)

 

$

(63,189

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized loss on marketable securities

 

 

(193

)

 

 

(178

)

 

 

(588

)

 

 

(704

)

Total other comprehensive loss

 

 

(193

)

 

 

(178

)

 

 

(588

)

 

 

(704

)

Comprehensive loss

 

$

(19,694

)

 

$

(18,433

)

 

$

(45,118

)

 

$

(63,893

)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances, September 30, 2025

 

 

21,387

 

 

$

214

 

 

$

469,771

 

 

$

(339

)

 

$

(404,929

)

 

$

64,717

 

Issuance of common stock from October 2025 public offering, net of issuance costs of $4,802

 

 

7,475

 

 

 

75

 

 

 

69,873

 

 

 

 

 

 

 

 

 

69,948

 

Exercise of stock options

 

 

16

 

 

 

 

 

 

141

 

 

 

 

 

 

 

 

 

141

 

Vesting of restricted stock units, net of withholding

 

 

141

 

 

 

1

 

 

 

(98

)

 

 

 

 

 

 

 

 

(97

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,810

 

 

 

 

 

 

 

 

 

3,810

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

10

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,938

)

 

 

(11,938

)

Balances, December 31, 2025

 

 

29,019

 

 

$

290

 

 

$

543,497

 

 

$

(329

)

 

$

(416,867

)

 

$

126,591

 

Exercise of stock options

 

 

5

 

 

 

 

 

 

49

 

 

 

 

 

 

 

 

 

49

 

Vesting of restricted stock units, net of withholding

 

 

37

 

 

 

1

 

 

 

(306

)

 

 

 

 

 

 

 

 

(305

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,748

 

 

 

 

 

 

 

 

 

3,748

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(405

)

 

 

 

 

 

(405

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,091

)

 

 

(13,091

)

Balances, March 31, 2026

 

 

29,061

 

 

$

291

 

 

$

546,988

 

 

$

(734

)

 

$

(429,958

)

 

$

116,587

 

Exercise of stock options

 

 

55

 

 

 

 

 

 

492

 

 

 

 

 

 

 

 

 

492

 

Vesting of restricted stock units, net of withholding

 

 

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,683

 

 

 

 

 

 

 

 

 

3,683

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(193

)

 

 

 

 

 

(193

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(19,501

)

 

 

(19,501

)

Balances, June 30, 2026

 

 

29,120

 

 

$

291

 

 

$

551,163

 

 

$

(927

)

 

$

(449,459

)

 

$

101,068

 

 

 


 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances, September 30, 2024

 

 

21,194

 

 

$

212

 

 

$

451,340

 

 

$

302

 

 

$

(323,040

)

 

$

128,814

 

Exercise of stock options

 

 

11

 

 

 

 

 

 

94

 

 

 

 

 

 

 

 

 

94

 

Vesting of restricted stock units, net of withholding

 

 

128

 

 

 

1

 

 

 

(138

)

 

 

 

 

 

 

 

 

(137

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

5,666

 

 

 

 

 

 

 

 

 

5,666

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(331

)

 

 

 

 

 

(331

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,290

)

 

 

(22,290

)

Balances, December 31, 2024

 

 

21,333

 

 

$

213

 

 

$

456,962

 

 

$

(29

)

 

$

(345,330

)

 

$

111,816

 

Vesting of restricted stock units, net of withholding

 

 

44

 

 

 

1

 

 

 

(128

)

 

 

 

 

 

 

 

 

(127

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,688

 

 

 

 

 

 

 

 

 

4,688

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(195

)

 

 

 

 

 

(195

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,644

)

 

 

(22,644

)

Balances, March 31, 2025

 

 

21,377

 

 

$

214

 

 

$

461,522

 

 

$

(224

)

 

$

(367,974

)

 

$

93,538

 

Vesting of restricted stock units, net of withholding

 

 

1

 

 

 

 

 

 

(3

)

 

 

 

 

 

 

 

 

(3

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,177

 

 

 

 

 

 

 

 

 

4,177

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(178

)

 

 

 

 

 

(178

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,255

)

 

 

(18,255

)

Balances, June 30, 2025

 

 

21,378

 

 

$

214

 

 

$

465,696

 

 

$

(402

)

 

$

(386,229

)

 

$

79,279

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

7


ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(44,530

)

 

$

(63,189

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

11,241

 

 

 

14,531

 

Depreciation and amortization expense

 

 

3,624

 

 

 

3,302

 

Non-cash interest associated with the sale of future royalties

 

 

1,743

 

 

 

(1,399

)

Non-cash royalty revenue

 

 

417

 

 

 

(2,020

)

Premium paid on marketable securities

 

 

(1,240

)

 

 

 

Amortization of premiums on marketable securities

 

 

330

 

 

 

1,461

 

Loss on disposal of property and equipment

 

 

 

 

 

6

 

Change in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

348

 

 

 

(1,687

)

Prepaid expenses and other current assets

 

 

1,011

 

 

 

2,173

 

Income tax receivable

 

 

 

 

 

31,975

 

Operating lease, right-of-use assets

 

 

1,697

 

 

 

3,607

 

Other long-term assets

 

 

(18

)

 

 

 

Accounts payable

 

 

1,339

 

 

 

(588

)

Accrued expenses

 

 

(2,568

)

 

 

(2,360

)

Operating lease liabilities

 

 

(2,247

)

 

 

1,384

 

Other long-term liabilities

 

 

26

 

 

 

21

 

Net cash used in operating activities

 

 

(28,827

)

 

 

(12,783

)

Cash flows from investing activities

 

 

 

 

 

 

Purchase of marketable securities

 

 

(216,084

)

 

 

(141,008

)

Proceeds from maturities and sale of marketable securities

 

 

194,898

 

 

 

190,497

 

Purchase of property and equipment

 

 

(165

)

 

 

(11,438

)

Net cash (used in) provided by investing activities

 

 

(21,351

)

 

 

38,051

 

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from October 2025 public offering, net of issuance costs of $4,802

 

 

69,948

 

 

 

 

Payments on royalty sale liability, net of imputed interest

 

 

(18,929

)

 

 

(18,124

)

Payments for settlement of share-based awards

 

 

(402

)

 

 

(267

)

Proceeds from the exercise of stock options

 

 

682

 

 

 

94

 

Net cash provided by (used in) financing activities

 

 

51,299

 

 

 

(18,297

)

Net increase in cash, cash equivalents and restricted cash

 

 

1,121

 

 

 

6,971

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

35,658

 

 

 

41,201

 

Cash, cash equivalents and restricted cash at end of period

 

$

36,779

 

 

$

48,172

 

Supplemental disclosure of non-cash information:

 

 

 

 

 

 

Purchases of fixed assets included in accounts payable and
   accrued expenses

 

$

6

 

 

$

1,396

 

Operating lease liabilities arising from obtaining right-of-use assets

 

$

 

 

$

1,199

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Cash paid for interest

 

$

8,761

 

 

$

7,185

 

Cash received from tenant improvement allowances

 

$

330

 

 

$

5,146

 

Cash received from income tax refund

 

$

 

 

$

33,785

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


ENANTA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

(amounts in thousands, except per share data)

1. Nature of the Business and Basis of Presentation

Enanta Pharmaceuticals, Inc. (collectively with its subsidiary, the “Company”), incorporated in Delaware in 1995, is a biotechnology company that uses its robust, chemistry-driven approach and drug discovery capabilities to discover and develop small molecule drugs for virology and immunology indications. The Company discovered glecaprevir, the second of two antiviral protease inhibitors developed through its collaboration with AbbVie for the treatment of acute or chronic infection with hepatitis C virus, or HCV. Glecaprevir is co-formulated as part of AbbVie’s leading brand of direct-acting antiviral combination treatment for HCV, which has been marketed under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir) since 2017 for the treatment of chronic HCV. MAVYRET and MAVIRET were also approved as the first and only treatments for acute HCV infection in the United States and the European Union in June 2025 and June 2026, respectively.

The Company is subject to many of the risks common to companies in the biotechnology industry, including but not limited to, the uncertainties of research and development, competition from technological innovations of others, dependence on collaborative arrangements, protection of proprietary technology, dependence on key personnel and compliance with government regulation. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approvals, prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure, and extensive compliance reporting capabilities.

 

Unaudited Interim Financial Information

The condensed consolidated balance sheet as of September 30, 2025 was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited condensed consolidated financial statements as of June 30, 2026 and for the three and nine months ended June 30, 2026 and 2025 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025.

In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2026 and results of operations for the three and nine months ended June 30, 2026 and 2025 and cash flows for the nine months ended June 30, 2026 and 2025 have been made. The results of operations for the three and nine months ended June 30, 2026 are not necessarily indicative of the results of operations that may be expected for subsequent quarters or the year ending September 30, 2026.

The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP. All amounts in the condensed consolidated financial statements and in the notes to the condensed consolidated financial statements, except per share amounts, are in thousands unless otherwise indicated.

The accompanying condensed consolidated financial statements have been prepared based on continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company began reporting a net loss in fiscal 2020 and reported a net loss of $44,530 for the nine months ended June 30, 2026 and $81,889 for the year ended September 30, 2025. As of June 30, 2026, the Company had an accumulated deficit of $449,459. The Company expects to continue to generate operating losses for the foreseeable future as the Company continues to advance its wholly-owned programs. As of June 30, 2026, the Company had $211,493 in cash, cash equivalents and short-term and long-term marketable securities. The Company expects that its cash, cash equivalents and short-term and long-term marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements. The Company may seek additional funding through equity offerings, non-dilutive financings, collaborations, strategic alliances or licensing agreements. The Company may not be able to obtain sufficient financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.

 

9


Follow-on Public Offering

In October 2025, the Company closed an underwritten public offering of its common stock. The Company issued and sold 7,475 shares of its common stock at a public offering price of $10.00 per share. The aggregate gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses, were $74,750.

 

2. Summary of Significant Accounting Policies

For the Company’s Significant Accounting Policies, please refer to its Annual Report on Form 10-K for the fiscal year ended September 30, 2025. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). There have been no material changes to the Company’s significant accounting policies since the beginning of this fiscal year.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, management’s judgments with respect to its revenue arrangements; liability related to the sale of future royalties; valuation of stock-based awards and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience.

Net Loss per Share

Basic net loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. In periods in which the Company has reported a net loss, diluted net loss per common share is the same as basic net loss per common share since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Therefore, the Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss as its effect would have been anti-dilutive:

 

 

 

 

As of June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Options to purchase common stock

 

 

6,667

 

 

 

5,953

 

Unvested rTSRUs

 

 

104

 

 

 

93

 

Unvested PSUs

 

 

104

 

 

 

93

 

Unvested restricted stock units

 

 

420

 

 

 

414

 

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) (“ASU 2023-09”), which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company in the fiscal year beginning October 1, 2025, with early adoption permitted. The Company does not expect ASU 2023-09 to have a material impact on the Company’s consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”), which requires public entities to provide disaggregated disclosure of income statement expenses. Public entities are required to disaggregate, in a tabular presentation, each relevant expense caption on the face of the consolidated statements of operations such as the following expenses: purchases of inventory, employee compensation, intangible asset amortization, and depreciation. ASU 2024-03 is effective for the Company in the fiscal year beginning October 1, 2027, with early adoption permitted. The Company is currently evaluating the potential impact that ASU 2024-03 may have on its financial statement disclosures.

10


3. Fair Value of Financial Assets and Liabilities

The following tables present information about the Company’s financial assets and liabilities that were subject to fair value measurement on a recurring basis as of June 30, 2026 and September 30, 2025, and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value:

 

 

Fair Value Measurements as of June 30, 2026 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

(in thousands)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

25,532

 

 

$

 

 

$

 

 

$

25,532

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury notes

 

 

178,074

 

 

 

 

 

 

 

 

 

178,074

 

 

$

203,606

 

 

$

 

 

$

 

 

$

203,606

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Series 1 nonconvertible preferred stock

 

$

 

 

$

 

 

$

1,311

 

 

$

1,311

 

 

$

 

 

$

 

 

$

1,311

 

 

$

1,311

 

 

 

 

Fair Value Measurements as of September 30, 2025 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

(in thousands)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

11,580

 

 

$

 

 

$

 

 

$

11,580

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury notes

 

 

156,566

 

 

 

 

 

 

 

 

 

156,566

 

 

$

168,146

 

 

$

 

 

$

 

 

$

168,146

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Series 1 nonconvertible preferred stock

 

$

 

 

$

 

 

$

1,311

 

 

$

1,311

 

 

$

 

 

$

 

 

$

1,311

 

 

$

1,311

 

During the three and nine months ended June 30, 2026 and 2025, there were no transfers between Level 1, Level 2 and Level 3.

The fair value of Level 1 instruments is valued using quoted prices in active markets. The fair value of Level 2 instruments classified as marketable securities is typically determined through third-party pricing services. The pricing services use many observable market inputs to determine value, including reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, and current spot rates.

The 1,930 outstanding shares of Series 1 nonconvertible preferred stock as of June 30, 2026 and September 30, 2025 are measured at fair value. These outstanding shares are financial instruments that might require a transfer of assets because of the liquidation features in the contract and are therefore recorded as liabilities and measured at fair value. The fair value of the outstanding shares is based on significant inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The Company utilizes a probability-weighted valuation model which takes into consideration various outcomes that may require the Company to transfer assets upon liquidation. Changes in the fair values of the Series 1 nonconvertible preferred stock are recognized in other income (expense) in the condensed consolidated statements of operations.

The recurring Level 3 fair value measurements of the Company’s outstanding Series 1 nonconvertible preferred stock using probability-weighted discounted cash flow include the following significant unobservable inputs:

 

 

 

Range

 

 

 

June 30,

 

September 30,

 

Unobservable Input

 

2026

 

2025

 

Probabilities of payout

 

0%-65%

 

0%-65%

 

Discount rate

 

8.25%

 

8.25%

 

 

There were no changes in the fair value of nonconvertible preferred stock during the three and nine months ended June 30, 2026 and 2025.

11


In April 2023, the Company entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which the Company was paid a $200,000 cash purchase price in exchange for 54.5% of future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. The Company accounted for the upfront payment as a liability related to the sale of future royalties. The carrying value of the liability related to the sale of future royalties approximates fair value as of June 30, 2026 and is based on current estimates of future royalties expected to be paid to OMERS over the next 6 years, which are considered Level 3 inputs. See Note 7 for a rollforward of the liability.

4. Marketable Securities

As of June 30, 2026 and September 30, 2025, the fair value of available-for-sale marketable securities, by type of security, was as follows:

 

 

June 30, 2026

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Credit Losses

 

 

Fair Value

 

 

 

(in thousands)

 

U.S. Treasury notes

 

$

178,617

 

 

$

 

 

$

(543

)

 

$

 

 

$

178,074

 

 

 

$

178,617

 

 

$

 

 

$

(543

)

 

$

 

 

$

178,074

 

 

 

 

September 30, 2025

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Credit Losses

 

 

Fair Value

 

 

 

(in thousands)

 

U.S. Treasury notes

 

$

156,521

 

 

$

47

 

 

$

(2

)

 

$

 

 

$

156,566

 

 

 

$

156,521

 

 

$

47

 

 

$

(2

)

 

$

 

 

$

156,566

 

 

As of June 30, 2026 and September 30, 2025, marketable securities consisted of investments that mature within one year, with the exception of certain U.S. Treasury notes as of June 30, 2026 which have maturities between one and two years and an aggregate fair value of $21,987.

5. Accrued Expenses

Accrued expenses and other current liabilities consisted of the following as of June 30, 2026 and September 30, 2025:

 

 

June 30,

 

 

September 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Accrued payroll and related expenses

 

$

4,932

 

 

$

6,469

 

Accrued research and development expenses

 

 

2,270

 

 

 

1,800

 

Accrued professional fees

 

 

1,148

 

 

 

1,386

 

Accrued pharmaceutical drug manufacturing

 

 

1,598

 

 

 

2,691

 

Accrued other

 

 

235

 

 

 

405

 

 

 

$

10,183

 

 

$

12,751

 

 

6. AbbVie Collaboration

The Company has a Collaborative Development and License Agreement (as amended, the “AbbVie Agreement”) with AbbVie to identify, develop and commercialize HCV NS3 and NS3/4A protease inhibitor compounds, including paritaprevir and glecaprevir, under which the Company has received license payments, proceeds from a sale of preferred stock, research funding payments, milestone payments and royalties totaling approximately $1,372,000 through June 30, 2026. Since the Company satisfied all of its performance obligations under the AbbVie Agreement by the end of fiscal 2011, all milestone payments received since then have been recognized as revenue when the milestones were achieved by AbbVie.

The Company is receiving annually tiered royalties per Company protease product ranging from ten percent up to twenty percent, or on a blended basis from ten percent up to the high teens, on the portion of AbbVie’s calendar year net sales of each HCV regimen that is allocated to the protease inhibitor in the regimen. Beginning with each January 1, the cumulative net sales of a given royalty-bearing protease inhibitor product start at zero for purposes of calculating the tiered royalties on a product-by-product basis.

12


7. Liability Related to the Sale of Future Royalties

In April 2023, the Company entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which the Company was paid a $200,000 cash purchase price in exchange for 54.5% of future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price.

Because the royalty sale agreement will be paid back to OMERS up to a capped amount, as well as the Company’s significant continuing involvement in the generation of future cash flows under its AbbVie Agreement, the Company recorded the proceeds from the transaction as a liability on its condensed consolidated balance sheets which will be amortized as interest expense in the condensed consolidated statements of operations under the effective interest rate method over the life of the royalty sale agreement. The Company will continue to record the full amount of royalties earned on MAVYRET/MAVIRET sales as royalty revenue in its condensed consolidated statements of operations.

The Company’s liability related to the sale of future royalties is estimated based on forecasted worldwide MAVYRET/MAVIRET royalties to be paid to OMERS over the course of the royalty sale agreement. This estimate requires significant judgment, including the amount and timing of royalty payments up until the end of the royalty sale agreement, which is estimated to be the stated term of June 30, 2032. As royalties are earned by OMERS, the liability is reduced on the Company’s condensed consolidated balance sheets.

At June 30, 2026, the estimated future cash flows resulted in an effective annual imputed interest rate of approximately 12.8%.

The following table summarizes the activity of the liability related to the sale of future royalties:

 

 

Liability related to the sale of future royalties

 

 

 

(in thousands)

 

Balance - September 30, 2025

 

$

141,842

 

Royalty payable to purchaser

 

 

(7,826

)

Payments on royalty sale liability

 

 

(19,472

)

Interest expense

 

 

10,529

 

Balance - June 30, 2026

 

$

125,073

 

 

8. Stock-Based Awards

The Company grants stock-based awards, including stock options, restricted stock units and other unit awards under its 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by its stockholders on February 28, 2019 and amended in March 2021, March 2022, March 2023, March 2024, December 2024, March 2025 and March 2026 and its 2024 Inducement Stock Incentive Plan, which was adopted by the Board of Directors in April 2024 for awards to new employees and amended in December 2024. The Company also has outstanding stock option awards under its 2012 Equity Incentive Plan (the “2012 Plan”), but is no longer granting awards under this plan.

 

The following table summarizes stock option activity, including aggregate intrinsic value, for the year-to-date period ended June 30, 2026:

 

 

Shares
Issuable
Under
Options

 

 

Weighted
Average
Exercise
Price

 

 

Weighted
Average
Remaining
Contractual
Term

 

 

Aggregate
Intrinsic
Value

 

 

 

(in thousands)

 

 

 

 

 

(in years)

 

 

(in thousands)

 

Outstanding as of September 30, 2025

 

 

5,759

 

 

$

36.31

 

 

 

6.0

 

 

$

6,457

 

Granted

 

 

1,291

 

 

 

13.72

 

 

 

 

 

 

 

Exercised

 

 

(76

)

 

 

8.94

 

 

 

 

 

 

 

Forfeited

 

 

(23

)

 

 

21.39

 

 

 

 

 

 

 

Expired

 

 

(284

)

 

 

36.24

 

 

 

 

 

 

 

Outstanding as of June 30, 2026

 

 

6,667

 

 

$

32.30

 

 

 

6.3

 

 

$

12,570

 

Options vested and expected to vest as of
   June 30, 2026

 

 

6,667

 

 

$

32.30

 

 

 

6.3

 

 

$

12,570

 

Options exercisable as of June 30, 2026

 

 

4,437

 

 

$

42.16

 

 

 

5.1

 

 

$

5,989

 

 

13


Market and Performance-Based Stock Unit Awards

The Company awards both performance share units, or PSUs, and relative total stockholder return units, or rTSRUs, to its executive officers. The number of units granted represents the target number of shares of common stock that may be earned; however, the actual number of shares that may be earned ranges from 0% to 150% of the target number. The number of shares cancelled represents the target number of shares, less any shares that vested. The following table summarizes PSU and rTSRU activity (at target) for the year-to-date period ended June 30, 2026:

 

 

PSUs

 

 

rTSRUs

 

 

 

Shares

 

 

Weighted
Average
Grant Date Fair
Value

 

 

Shares

 

 

Weighted
Average
Grant Date Fair
Value

 

 

 

(in thousands)

 

 

 

 

 

(in thousands)

 

 

 

 

Unvested as of September 30, 2025

 

 

93

 

 

$

8.47

 

 

 

93

 

 

$

9.57

 

Granted

 

 

58

 

 

 

15.39

 

 

 

58

 

 

 

18.33

 

Vested

 

 

(14

)

 

 

9.59

 

 

 

(44

)

 

 

20.27

 

Cancelled

 

 

(33

)

 

 

9.58

 

 

 

(3

)

 

 

10.38

 

Unvested as of June 30, 2026

 

 

104

 

 

$

11.81

 

 

 

104

 

 

$

13.99

 

Restricted Stock Units

The following table summarizes the restricted stock unit activity for the year-to-date period ended June 30, 2026:

 

 

Restricted Stock
Units

 

 

Weighted
Average Grant
Date Fair
Value

 

 

 

(in thousands)

 

 

 

 

Unvested as of September 30, 2025

 

 

408

 

 

$

24.15

 

Granted

 

 

181

 

 

 

13.70

 

Vested

 

 

(152

)

 

 

33.36

 

Cancelled

 

 

(17

)

 

 

26.51

 

Unvested as of June 30, 2026

 

 

420

 

 

$

16.28

 

 

Stock-Based Compensation Expense

During the three and nine months ended June 30, 2026 and 2025, the Company recognized the following stock-based compensation expense:

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

 

(in thousands)

 

Research and development

 

$

1,566

 

 

$

1,783

 

 

$

4,757

 

 

$

4,605

 

General and administrative

 

 

2,117

 

 

 

2,394

 

 

 

6,484

 

 

 

9,926

 

 

$

3,683

 

 

$

4,177

 

 

$

11,241

 

 

$

14,531

 

 

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

 

(in thousands)

 

Stock options

 

$

2,437

 

 

$

2,805

 

 

$

7,493

 

 

$

9,149

 

Restricted stock units

 

 

918

 

 

 

1,262

 

 

 

2,935

 

 

 

4,011

 

rTSRUs

 

 

168

 

 

 

110

 

 

 

476

 

 

 

557

 

Performance stock units

 

 

160

 

 

 

 

 

 

337

 

 

 

814

 

 

$

3,683

 

 

$

4,177

 

 

$

11,241

 

 

$

14,531

 

 

During the three and nine months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense for performance-based stock units for which vesting became probable upon achievement of performance-based targets that occurred during the performance period.

As of June 30, 2026, the Company had an aggregate of $21,609 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.4 years.

14


9. Income Taxes

For the three and nine months ended June 30, 2026, the Company recorded an income tax expense of $36 and $67, respectively, as compared to an income tax expense of $29 and income tax benefit of $1,692 during the three and nine months ended June 30, 2025. The income tax benefit for the nine months ended June 30, 2025 was primarily due to an additional federal income tax refund from a net operating loss carryback of $871. The federal income tax refund of $33,785, inclusive of interest, was received in April 2025.

On July 4, 2025, the U.S. government enacted the One Big Beautiful Bill Act, which includes several changes to U.S. federal income tax law, including the temporary and permanent extension of expiring provisions of the Tax Cuts and Jobs Act of 2017, such as 100% bonus depreciation and immediate expensing of domestic research and development costs. The new legislation has multiple effective dates, with certain provisions that became effective in 2025 and others in the future. The Company determined that the legislation does not have a material impact on its condensed consolidated financial statements for the three and nine months ended June 30, 2026.

10. Commitments and Contingencies

Litigation and Contingencies Related to Use of Intellectual Property

From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business. Except as described below, the Company currently is not a party to any threatened or pending litigation. However, third parties might allege that the Company or its collaborators are infringing their patent rights or that the Company is otherwise violating their intellectual property rights. Such third parties may resort to litigation against the Company or its collaborators, which the Company has agreed to indemnify. With respect to some of these patents, the Company expects that it will be required to obtain licenses and could be required to pay license fees or royalties, or both. These licenses may not be available on acceptable terms, or at all. A costly license, or inability to obtain a necessary license, would have a material adverse effect on the Company’s financial condition, results of operations or cash flows. The Company accrues contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.

In June 2022, the Company filed suit in the United States District Court for the District of Massachusetts against Pfizer Inc. seeking damages for infringement of U.S. Patent No. 11,358,953 (the “’953 Patent”) in the manufacture, use, and sale of Pfizer’s COVID-19 antiviral, Paxlovid™ (nirmatrelvir tablets; ritonavir tablets). The United States Patent and Trademark Office awarded the ’953 Patent to the Company in June 2022 based on the Company's July 2020 patent application describing coronavirus protease inhibitors invented by the Company. In December 2024, the District Court issued a summary judgment decision ruling that the asserted claims of the ’953 Patent were invalid. The Company filed a notice of appeal with the United States Court of Appeals for the Federal Circuit, and, in June 2026, the Federal Circuit affirmed the decision of the District Court and ruled that the claims of the ’953 Patent were invalid. On July 23, 2026, the Company filed a combined petition for panel or en banc rehearing of the Federal Circuit’s decision. The timing for a decision on the petition remains uncertain; however, the Company anticipates a decision from the Federal Circuit before the end of September 2026.

In August 2025, the Company filed a patent infringement action in the Unified Patent Court (the “UPC”) of the European Union against Pfizer Inc. and certain of its subsidiaries. The suit seeks a determination of liability for infringement of European Patent No. EP 4 051 265 (the “’265 Patent”) in connection with Pfizer’s manufacture, use, and sale of Paxlovid™ (nirmatrelvir tablets; ritonavir tablets) in the 18 EU member states participating in the UPC. The ’265 Patent is the European counterpart to the ’953 Patent. A hearing on the infringement action and counterclaim for revocation has been scheduled for September 29, 2026 and, under the UPC procedures, a decision is expected to be rendered within weeks thereafter. If the UPC determines there has been infringement, subsequent proceedings would be required to determine damages. In May 2026, Pfizer also filed an opposition against the ’265 Patent with the European Patent Office (the “EPO”). All timelines remain subject to potential rights of appeal and other customary proceedings in European patent litigation and EPO procedures.

The Company records all legal expenses associated with the patent infringement suits as incurred in the consolidated statements of operations.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to customers, vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from services to be provided to the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. In addition, the Company maintains directors’ and officers’ insurance coverage. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial

15


position, results of operations or cash flows, and has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of June 30, 2026.

 

 

11. Segment Information

The Company manages its operations as a single operating segment for the purpose of assessing performance and making operating decisions. The Company’s singular focus is on discovering and developing small molecule drugs with an emphasis on virology and immunology indications. The Company’s Chief Operating Decision Maker (“CODM”) is the Company’s Chief Executive Officer (“CEO”). The CODM reviews consolidated operating results and utilizes net loss from the statement of operations against budget forecasts as the primary measure of segment profit or loss in making decisions surrounding allocating resources and assessing performance of the Company. The CODM is regularly provided detailed expense information, including expenses by expense category and program. The CODM makes decisions surrounding capital and personnel allocation using this information on a consolidated basis. Asset information on a reportable segment basis is not disclosed as this information is not separately identified and internally reported to the Company’s CODM. The CODM is regularly provided information on total cash, which is inclusive of cash, cash equivalents and short-term and long-term marketable securities, as a measure of segment assets. As of June 30, 2026, the Company’s cash, cash equivalents and short-term and long-term marketable securities were $211,493. The following table presents selected financial information with respect to the Company’s single operating segment for the three and nine months ended June 30, 2026 and 2025 (in thousands):

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

14,359

 

 

$

18,314

 

 

$

50,133

 

 

$

50,199

 

Total revenue

 

 

14,359

 

 

 

18,314

 

 

 

50,133

 

 

 

50,199

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

RSV

 

 

5,893

 

 

 

15,412

 

 

 

15,746

 

 

 

51,620

 

Total virology

 

 

5,893

 

 

 

15,412

 

 

 

15,746

 

 

 

51,620

 

KIT

 

 

4,232

 

 

 

4,057

 

 

 

12,803

 

 

 

11,902

 

STAT6

 

 

7,083

 

 

 

4,678

 

 

 

20,578

 

 

 

10,670

 

MRGPRX2

 

 

3,368

 

 

 

2,292

 

 

 

8,237

 

 

 

6,840

 

Total immunology

 

 

14,683

 

 

 

11,027

 

 

 

41,618

 

 

 

29,412

 

Early discovery

 

 

1,421

 

 

 

603

 

 

 

4,572

 

 

 

1,115

 

Other pipeline programs

 

 

129

 

 

 

168

 

 

 

492

 

 

 

784

 

Total other programs

 

 

1,550

 

 

 

771

 

 

 

5,064

 

 

 

1,899

 

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

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(4,130

)

 

 

(1,618

)

 

 

(10,529

)

 

 

(5,294

)

Interest and investment income, net

 

 

1,901

 

 

 

2,285

 

 

 

6,407

 

 

 

7,376

 

Total other (expense) income, net

 

 

(2,229

)

 

 

667

 

 

 

(4,122

)

 

 

2,082

 

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

)

 

12. Subsequent Events

On July 2, 2026, the Company entered into an Open Market Sale AgreementSM with Jefferies LLC, as sales agent, under which it may offer and sell shares of its common stock, having an aggregate offering price of up to $75.0 million, from time to time through Jefferies under the at-the-market (ATM) facility. The Company has not issued any shares of common stock under this sale agreement through the filing date of this Form 10-Q.

 

 

16


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q, or Form 10-Q, and the audited consolidated financial statements and notes thereto for our fiscal year ended September 30, 2025 included in our Annual Report on Form 10-K for that fiscal year, which is referred to as our 2025 Form 10-K. Please refer to our note regarding forward-looking statements on page 2 of this Form 10-Q, which is incorporated herein by this reference.

The Enanta name and logo are our trademarks. This Form 10-Q also includes trademarks, trade names and service marks of other persons. All other trademarks, trade names and service marks appearing in this Form 10-Q are the property of their respective owners.

Overview

We are a biotechnology company that uses our robust, chemistry-driven approach and drug discovery capabilities to discover and develop small molecule drugs for virology and immunology indications.

Virology:

We discovered glecaprevir, the second of two antiviral protease inhibitors developed through our collaboration with AbbVie for the treatment of acute or chronic infection with hepatitis C virus, or HCV. Glecaprevir is co-formulated as part of AbbVie’s leading brand of direct-acting antiviral, combination treatment for HCV, which has been marketed under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir) since 2017 for the treatment of chronic HCV. MAVYRET and MAVIRET were also approved as the first and only treatments for acute HCV infection in the United States and the European Union in June 2025 and June 2026, respectively.

Our active development programs in virology are focused on respiratory syncytial virus, or RSV, the most common cause of bronchiolitis and pneumonia and a leading cause of U.S. hospitalization in young children, and a significant cause of respiratory illness in older adults. Populations at high risk for severe RSV infection include infants and young children, adults older than 65 years of age, and those with comorbidities such as chronic heart or lung disease. CDC estimates from the United States 2024-2025 RSV season indicate that RSV led to up to 6.8 million outpatient visits, approximately 370,000 hospitalizations, and up to 24,000 deaths. We estimate a global market opportunity of over $2 billion for an oral RSV antiviral for children and all high-risk adults, with a potential total addressable population of greater than 3 million patients in the United States. Additionally, we believe that the recent FDA approval of at-home combination self-tests capable of detecting RSV, influenza A & B, and COVID-19 will further drive RSV diagnosis and potentially enable a test-to-treat model for zelicapavir.

We also have clinical-stage programs in virology for SARS-CoV-2, the virus that causes COVID-19, and Hepatitis B virus, or HBV, the most prevalent chronic hepatitis.

Immunology:

In immunology, we are designing and developing highly potent and selective, oral small molecule inhibitors for the treatment of type 2 inflammatory disease by targeting key mechanisms of the immune response. An overactive immune response is a primary driver of a number of inflammatory diseases for which there is an enduring unmet need including atopic dermatitis, or AD, urticaria, asthma, prurigo nodularis, or PN, chronic rhinosinusitis with nasal polyps, or CRSwNP, as well as some forms of chronic obstructive pulmonary disease, or COPD, eosinophilic esophagitis, or EoE, allergic rhinoconjunctivitis, or ARC, and other conditions. Based on industry reports, by 2032 the market is projected to be approximately $40 billion for urticaria and AD, approximately $40 billion for the combined market of asthma, COPD, CRSwNP, EoE, ARC and PN and could include an additional $40 billion or greater taking into account potential expansion into gastrointestinal and neurology indications thought to be associated with mast cells.

Our initial immunology targets involve the following mechanisms:

KIT, a receptor tyrosine kinase, critical for regulating mast cell survival and activation, including release of potent inflammatory mediators such as histamine, which is a primary driver of inflammation and implicated in multiple allergic diseases;
STAT6, a transcription factor uniquely responsible for interleukin-4, or IL-4, and interleukin-13, or IL-13, cell signaling, which drives a type 2 dominant phenotype and downstream inflammation; and
MRGPRX2, a non-canonical G-Protein-Coupled-Receptor, or GPCR, expressed predominantly on mast cells, which upon activation triggers degranulation and release of inflammation mediating components, leading to an inflammatory response that is a driver in multiple allergic diseases, and potentially implicated in migraine.

17


These mechanisms are implicated, along with others, in several diseases, and it is not uncommon for an efficacious treatment for one disease to be tested and approved for other immunology indications. In addition, these mechanisms are orthogonal approaches that may provide additive or complementary benefit if used in combination. We currently plan to focus our initial immunology drug development, proof-of-concept efforts on the following disease indications:

Urticaria, including chronic spontaneous urticaria, or CSU, a severely debilitating, chronic inflammatory skin disease manifested by hives, angioedema, which is swelling of soft tissues, or both, but with no identified triggers, which has an estimated global prevalence of between 0.5% – 1% of the population, resulting in approximately 1.75–3.5 million people with this condition at any given time in the U.S. alone or chronic inducible urticaria (CIndU) of various forms with a variety of known triggers; and
Atopic dermatitis, or AD, a chronic dermatological disease characterized by dry, red, inflamed, irritated and itchy skin with significant quality of life impacts such as leading a limited lifestyle, avoidance of social interactions and a reduced range of activities, with AD affecting 7.3% of the U.S. adult population, of whom approximately 40% have moderate to severe disease.

 

As of June 30, 2026, we had $211.5 million in cash, cash equivalents and short-term and long-term marketable securities. Based on our operating plan, we believe that our existing cash, cash equivalents and short-term and long-term marketable securities as of June 30, 2026, as well as the cash flows from our retained portion of future HCV royalties, will enable us to fund our operating expenses and capital expenditure requirements into fiscal 2029.

 

Our Wholly-Owned Programs

All of our development programs are wholly-owned, including our RSV and immunology programs.

RSV. We have two clinical stage candidates for RSV – zelicapavir (EDP-938) and EDP-323, both of which have Fast Track designation from the U.S. Food and Drug Administration, or FDA. Both candidates inhibit viral replication and the production of new virions for both major subgroups of RSV, and differ from fusion inhibitors, which act only at viral entry. Zelicapavir is an inhibitor of the RSV N-protein, and EDP-323 is an inhibitor of the RSV L-protein.

Zelicapavir - N-protein Inhibitor Candidate: Zelicapavir, a once-daily, oral, direct-acting antiviral selectively targeting the N-protein, has demonstrated statistically significant reductions in RSV viral load and symptoms in a Phase 2 human challenge model clinical study. We believe that zelicapavir has the greatest potential to show optimal efficacy in high-risk populations since these patients have reduced RSV immunity or other comorbidities, which manifest in a higher and longer duration of viral replication and greater disease severity, allowing a bigger window to realize the full potential of zelicapavir. Our development program is focused on evaluating zelicapavir in high-risk populations, including high-risk adults and pediatric patients, all of which have significant unmet need:
o
High-Risk Adults Study of Zelicapavir. In September 2025, we announced positive topline results from a Phase 2b randomized, double-blind, placebo-controlled study evaluating zelicapavir in high-risk adults with RSV, including those who are older than 65 years of age and those who have asthma, chronic obstructive pulmonary disease, or congestive heart failure.
o
Pediatric Study of Zelicapavir. In December 2024, we announced positive topline results from the first-in-pediatrics Phase 2 randomized, double-blind, placebo-controlled study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with RSV.

In these Phase 2 clinical studies, zelicapavir has demonstrated a favorable safety profile, consistent with that observed in over 700 subjects exposed to zelicapavir to date, as well as antiviral activity and reductions in symptom duration.

o
Next Steps. In June 2026, we announced plans to initiate a registrational Phase 2b/3 clinical trial of zelicapavir in adults at high risk of severe outcomes from RSV infection. We expect to initiate this study named RESOLVE in the fourth quarter of 2026, with data from the Phase 2b portion of the RESOLVE study targeted for 2027. We also announced plans for a Phase 2b clinical trial of zelicapavir in pediatric patients with RSV. We initiated this pediatric study named LOTUS and dosed our first participant in the third quarter of 2026, with topline data expected in 2027. In parallel with these activities, we are exploring potential business development opportunities related to our RSV programs.
EDP-323 - L-protein Inhibitor Candidate: Our second clinical RSV candidate, EDP-323, is an oral, once-daily, direct-acting antiviral selectively targeting the RSV L-protein, a viral RNA-dependent RNA polymerase enzyme that contains multiple enzymatic activities required for RSV replication. EDP-323 has sub-nanomolar potency in vitro and protected mice from RSV infection in a dose-dependent manner as demonstrated by both virological and pathological endpoints. EDP-323 is not expected to have cross-resistance to other classes of inhibitors and has the potential to be used alone, or in combination with other RSV mechanisms, to broaden the treatment window or addressable patient populations.

18


o
Phase 2a Study of EDP-323. In September 2024, we announced positive topline results for EDP-323 in a Phase 2a challenge study of healthy adults infected with RSV, which demonstrated statistically significant reductions in RSV viral load and symptoms. In addition, a post-exposure prophylaxis analysis was performed in subjects who were not infected by Day 5 after RSV exposure. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure.

Immunology. We are leveraging our expertise in developing small molecule inhibitors to design and develop highly potent and selective oral medicines targeting the following mechanisms of immune response:

KIT Inhibitors. We have a clinical-stage program to develop oral KIT inhibitors for the treatment of CSU and potentially other mast cell-associated indications by depleting mast cells, thereby addressing a primary driver of these diseases. We have selected EDP-978 as our clinical candidate. EDP-978 demonstrates potent nanomolar activity in both binding and cellular function assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also demonstrates strong in vitro and in vivo absorption, distribution, metabolism and excretion, or ADME, properties, supporting once-daily dosing. In April 2026, we dosed our first participant 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 (SAD) phase, with a two-part food-effect cohort, and a multiple ascending dose (MAD) phase with a 14-day treatment period. We expect to report topline data from this trial in the fourth quarter of 2026.
STAT6 Inhibitors. We have a preclinical stage program to develop oral inhibitors of the signal transducer and activator of transcription 6 transcription factor, known as STAT6, for the treatment of type 2 immune-driven diseases. STAT6 is responsible for IL-4/IL-13 signaling, the pathway targeted by dupilumab, an IL-4 and IL-13 monoclonal antibody marketed as DUPIXENT®. We are initially focusing on AD for a proof-of-concept clinical study, and subsequently other indications where dupilumab is approved or has shown clinical activity. EPS-3903 is our lead development candidate, which has demonstrated nanomolar potency in both binding and cellular assays and is highly selective for STAT6 versus other STATs. EPS-3903 results in a rapid, continuous and complete (>90%) inhibition of phosphorylated STAT6 after oral dosing in mice. Importantly, EPS-3903 shows in vivo efficacy comparable to dupilumab, or an anti-mouse IL-4/IL-13 antibody, in multiple disease models of asthma (ovalbumin, house dust mite) and AD (MC903). EPS-3903 displays favorable in vitro and in vivo ADME properties, supportive of once-daily dosing potential. We are currently performing scale-up and Investigational New Drug application, or IND, enabling activities and are on track to file an IND in the second half of 2026.
MRGPRX2 Inhibitors. In January 2026, we announced a preclinical program targeting MRGPRX2, a GPCR, expressed predominantly on mast cells, for the treatment of type 2 immune driven diseases. MRGPRX2 inhibitors act through non-depleting mast cell modulation, including IgE-independent pathways, and may have the potential to address multiple chronic inflammatory diseases, including atopic dermatitis, asthma and others, with strong efficacy and a best-in-disease safety profile as well as potential in migraine. Currently, our prototype inhibitors demonstrate MRGPRX2 inhibition with nanomolar potency (EC50 of 1-2nM) in cellular assays and prevent skin mast cell activation in humanized MRGPRX2 mouse models. Further, our prototype inhibitors show potent activity across multiple MRGPRX2 agonists, with high selectivity for MRGPRX2 versus other GPCRs. These prototypes also demonstrate favorable in vitro and in vivo ADME properties, supportive of once-daily dosing potential. We are continuing to evaluate multiple compounds in preclinical studies and expect to select a development candidate in the second half of 2026.

We have utilized our internal chemistry and drug discovery capabilities to generate all of our development-stage programs. We continue to invest substantial resources in research programs to discover compounds targeting new disease areas.

 

The following table summarizes our product development pipeline in our virology and immunology programs:

 

19


 

Our Royalty Revenue Collaboration and Royalty Sale Agreement

Our royalty revenue is generated through our Collaborative Development and License Agreement with AbbVie, under which we have discovered and out-licensed to AbbVie two protease inhibitor compounds that have been clinically tested, manufactured, and commercialized by AbbVie as part of its combination regimens for HCV.

Glecaprevir is the HCV protease inhibitor we discovered that was developed by AbbVie in a fixed-dose combination with its NS5A inhibitor, pibrentasvir, for the treatment of chronic HCV. This product was also approved by the FDA and European Commission as the first and only treatment for acute HCV infection in June 2025 and June 2026, respectively. This patented combination, currently marketed under the brand names MAVYRET® (U.S.) and MAVIRET® (ex-U.S.), is referred to in this report as MAVYRET/MAVIRET. The first protease inhibitor developed through this collaboration, paritaprevir, is part of AbbVie’s initial HCV regimens, which have been almost entirely replaced by MAVYRET/MAVIRET. Since August 2017, substantially all of our royalty revenue has been derived from AbbVie’s net sales of MAVYRET/MAVIRET. Our ongoing royalty revenues from this regimen consist of annually tiered, double-digit, per-product royalties on 50% of the calendar year net sales of the glecaprevir/pibrentasvir combination in MAVYRET/MAVIRET. The annual royalty tiers return to the lowest tier for sales on and after each January 1.

In April 2023, we entered into a royalty sale agreement with an affiliate of OMERS, a Canadian public employee pension fund, pursuant to which we were paid a $200.0 million cash purchase price in exchange for 54.5% of our future quarterly royalty payments on net sales of MAVYRET/MAVIRET, after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments to OMERS equal to 1.42 times the purchase price.

For accounting purposes, we continue to record 100% of HCV royalties earned under the AbbVie agreement as royalty revenue in our consolidated statements of operations. The $200.0 million received in April 2023 was recognized on our condensed consolidated balance sheets as a liability, which will be reduced by the payments made to OMERS over the term of the Agreement. We recognize imputed interest expense over the life of the royalty sale agreement based on our estimated future MAVYRET/MAVIRET royalties.

 

Financial Operations Overview

We are currently funding all research and development for our wholly-owned programs, which are targeted toward the discovery and development of novel compounds. We are advancing zelicapavir into the RESOLVE study, a registrational Phase 2b/3 clinical trial in adults at high risk of severe outcomes from RSV infection. In addition, we are conducting the LOTUS study, a Phase 2b clinical trial of zelicapavir in pediatric patients with RSV, and a Phase 1 clinical trial of EDP-978, our lead immunology program. We are also continuing to conduct preclinical discovery research efforts in immunology.

20


As a result of the timing of our clinical and preclinical development programs, we expect our research and development expenses will fluctuate from period to period. In the next 12 months, we expect an increase in our external research and development expenses, primarily driven by the timing of clinical trials in our RSV programs.

To date, we have funded our operations primarily through royalty payments received under our collaboration agreement with AbbVie, a $200.0 million payment received in April 2023 from our royalty sale agreement and our existing cash, cash equivalents and short-term and long-term marketable securities. Based on our operating plan, we believe that our existing cash, cash equivalents and short-term and long-term marketable securities, as well as the cash flows from our retained portion of future HCV royalties, will enable us to fund our operating expenses and capital expenditure requirements into fiscal 2029.

Revenue

Our revenue is primarily derived from our collaboration agreement with AbbVie and AbbVie’s sales of MAVYRET/MAVIRET, an 8-week treatment regimen for acute or chronic HCV.

The following table is a summary of revenue recognized for the three and nine months ended June 30, 2026 and 2025:

 

 

Three Months Ended June 30,

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

14,359

 

 

$

18,314

 

 

$

50,133

 

 

$

50,199

 

Total revenue

 

$

14,359

 

 

$

18,314

 

 

$

50,133

 

 

$

50,199

 

As disclosed above regarding our OMERS royalty sale agreement, we only retain 45.5% of the cash payments from royalties on net sales of MAVYRET/MAVIRET occurring after June 30, 2023 through June 30, 2032, subject to a cap on aggregate payments to OMERS equal to 1.42 times OMERS’ purchase price.

 

Internal Programs

As our internal product candidates are currently in preclinical or clinical development, we have not generated any revenue from our own product sales. We do not expect to generate any revenue from product sales derived from these product candidates for at least the next several years.

Operating Expenses

Our operating expenses are comprised of research and development expenses and general and administrative expenses.

Research and Development Expenses

Research and development expenses consist of costs incurred to conduct basic research, such as the discovery and development of novel small molecules as therapeutics, as well as any external expenses of preclinical and clinical development activities. We expense all costs of research and development as incurred. These expenses consist primarily of:

third-party contract costs relating to research, formulation, manufacturing, preclinical study, and clinical trial activities;
personnel costs, including salaries, related benefits, and stock-based compensation for employees engaged in scientific research and development functions;
allocated facility-related costs;
laboratory consumables; and
third-party license fees.

At any given time, we have later stage programs in clinical development as well as several active early-stage research and drug discovery projects. Our internal resources, employees and infrastructure are utilized across multiple projects, including our early-stage discovery projects. As such, we report information regarding costs incurred based on our programs (i.e., disease area) rather than on a project specific basis. All indirect costs are allocated to programs based on headcount and square footage of our facilities. We expect that our research and development expenses will fluctuate from period to period as we advance our research and development programs. However, in the next 12 months, we expect an increase in our external research and development expenses, primarily driven by the timing of clinical trials in our RSV programs. To date, we have not identified any significant impact of inflation on spending in research and development, but it is uncertain whether there will be inflationary impacts in future periods.

21


Our research and drug discovery and development programs are in early stages; therefore, the successful development of our product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. Given the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of the current or future clinical trials of our product candidates or if, or to what extent, we will generate revenue from the commercialization and sale of any of our product candidates. We anticipate that we will make determinations as to which development programs to pursue and how much funding to direct to each program on an ongoing basis in response to the preclinical and clinical success and prospects of each product candidate, as well as ongoing assessments of the commercial potential of each product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel costs, which include salaries, related benefits and stock-based compensation, of our executive, finance, business and corporate development and other administrative functions. General and administrative expenses also include allocated facility-related costs not otherwise included in research and development expenses, directors’ and officers’ liability insurance premiums, professional fees for auditing, tax, and legal services, patent expenses and litigation expenses associated with prosecuting our patent infringement litigation.

We expect that general and administrative expenses may increase in the long term. To date we have not experienced a significant impact of inflation on general and administrative expenses.

Other Income (Expense)

Other income (expense) consists of interest expense, interest and investment income, net and the change in fair value of our outstanding Series 1 nonconvertible preferred stock. Interest expense consists of the interest expense and amortization of debt issuance costs associated with the royalty sale agreement with an affiliate of OMERS. Interest income consists of interest earned on our cash equivalents and marketable securities balances. Investment income consists of the amortization or accretion of any purchased premium or discount, respectively, on our marketable securities. The change in fair value of our Series 1 nonconvertible preferred stock relates to the remeasurement of these financial instruments from period to period as these instruments may require a transfer of assets because of the liquidation preference features of the underlying instrument.

Income Tax (Expense) Benefit

Income tax (expense) benefit is based on our best estimate of taxable net income (loss), applicable income tax rates, net research and development tax credits and carryforwards, net operating loss carrybacks and interest earned on such refunds, changes in valuation allowance estimates and deferred income taxes.

Results of Operations

Comparison of the Three Months Ended June 30, 2026 and 2025

 

 

Three Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Revenue

 

$

14,359

 

 

$

18,314

 

Research and development

 

 

22,126

 

 

 

27,210

 

General and administrative

 

 

9,469

 

 

 

9,997

 

Interest expense

 

 

(4,130

)

 

 

(1,618

)

Interest and investment income, net

 

 

1,901

 

 

 

2,285

 

Income tax expense

 

 

(36

)

 

 

(29

)

Net loss

 

$

(19,501

)

 

$

(18,255

)

Revenue

We recognized revenue of $14.4 million during the three months ended June 30, 2026 as compared to $18.3 million during the three months ended June 30, 2025. The $4.0 million decrease in revenue was primarily due to AbbVie’s lower reported HCV sales as compared to the same period in 2025.

Our royalty revenues eligible to be earned in the future will depend on AbbVie’s HCV market share, the pricing of the MAVYRET/MAVIRET regimen, the number of patients treated and the effect of the label expansion for MAVYRET/MAVIRET for the treatment of patients with acute HCV infection. In addition, at the beginning of each calendar year (the second quarter of our fiscal year), our royalty rate resets to the lowest tier for each of our royalty-bearing products licensed to AbbVie.

Beginning with the three months ended September 30, 2023, 54.5% of our quarterly royalty payments on net sales of MAVYRET/MAVIRET that are included in our total revenue are paid to OMERS through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price. The $200.0 million received in April 2023 was recognized on our

22


condensed consolidated balance sheets as a liability which will be reduced by the payments made to OMERS over the term of the royalty sale agreement. We will continue to record 100% of HCV royalties earned under the AbbVie Agreement as royalty revenue in our condensed consolidated statements of operations since the AbbVie Agreement has not been amended and is independent of our agreement with OMERS.

Research and development expenses

 

 

Three Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

R&D programs:

 

 

 

 

 

 

Virology

 

 

 

 

 

 

RSV

 

$

5,893

 

 

$

15,412

 

Total Virology

 

$

5,893

 

 

$

15,412

 

Immunology

 

 

 

 

 

 

KIT

 

 

4,232

 

 

 

4,057

 

STAT6

 

 

7,083

 

 

 

4,678

 

MRGPRX2

 

 

3,368

 

 

 

2,292

 

Total Immunology

 

$

14,683

 

 

$

11,027

 

Other Programs

 

 

 

 

 

 

Early discovery

 

 

1,421

 

 

 

603

 

Other pipeline programs

 

 

129

 

 

 

168

 

Total Other Programs

 

$

1,550

 

 

$

771

 

Total research and development expenses

 

$

22,126

 

 

$

27,210

 

Research and development expenses for the three months ended June 30, 2026 decreased by $5.1 million compared to the same period in 2025.

Virology

The costs in our virology programs decreased by $9.5 million due to the timing of clinical trials in our RSV programs.

Immunology

The costs in our immunology programs increased by $3.7 million due to scale-up and IND-enabling activities for such programs.

Other Programs

Other program costs increased by $0.8 million as we advanced early-stage drug discovery efforts.

General and administrative expenses

General and administrative expenses decreased by $0.5 million for the three months ended June 30, 2026 compared to the same period in 2025. The decrease was primarily due to lower stock-based compensation expenses during the three months ended June 30, 2026.

Other income (expense)

Changes in components of other income (expense) were as follows:

Interest expense

Interest expense increased by $2.5 million for the three months ended June 30, 2026, as compared to the same period in 2025, due to an increase in forecasted royalties arising from AbbVie’s product sales under the AbbVie Agreement and corresponding royalty payment to OMERS arising from such sales pursuant to our OMERS royalty sales agreement.

Interest and investment income, net

Interest and investment income, net, decreased by $0.4 million for the three months ended June 30, 2026, as compared to the same period in 2025. The decrease was due to lower interest rates year over year.

Income tax expense

The income tax expense of less than $0.1 million during the three months ended June 30, 2026 and 2025 was primarily due to state income taxes.

 

23


On July 4, 2025, the U.S. government enacted the One Big Beautiful Bill Act, which includes several changes to U.S. federal income tax law, including the temporary and permanent extension of expiring provisions of the Tax Cuts and Jobs Act of 2017, such as 100% bonus depreciation and immediate expensing of domestic research and development costs. The new legislation has multiple effective dates, with certain provisions effective in 2025 and others in the future. We determined that the legislation does not have a material impact on our condensed consolidated financial statements for the three and nine months ended June 30, 2026.

Results of Operations

Comparison of the Nine Months Ended June 30, 2026 and 2025

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Revenue

 

$

50,133

 

 

$

50,199

 

Research and development

 

 

62,428

 

 

 

82,931

 

General and administrative

 

 

28,046

 

 

 

34,231

 

Interest expense

 

 

(10,529

)

 

 

(5,294

)

Interest and investment income, net

 

 

6,407

 

 

 

7,376

 

Income tax (expense) benefit

 

 

(67

)

 

 

1,692

 

Net loss

 

$

(44,530

)

 

$

(63,189

)

Revenue

We recognized revenue of $50.1 million during the nine months ended June 30, 2026 as compared to $50.2 million during the nine months ended June 30, 2025. The $0.1 million decrease in revenue was primarily due to a slight decrease in AbbVie’s reported HCV sales as compared to the same period in 2025.

Research and development expenses

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

R&D programs:

 

 

 

 

 

 

Virology

 

 

 

 

 

 

RSV

 

$

15,746

 

 

$

51,620

 

Total Virology

 

$

15,746

 

 

$

51,620

 

Immunology

 

 

 

 

 

 

KIT

 

 

12,803

 

 

 

11,902

 

STAT6

 

 

20,578

 

 

 

10,670

 

MRGPRX2

 

 

8,237

 

 

 

6,840

 

Total Immunology

 

$

41,618

 

 

$

29,412

 

Other Programs

 

 

 

 

 

 

Early discovery

 

 

4,572

 

 

 

1,115

 

Other pipeline programs

 

 

492

 

 

 

784

 

Total Other Programs

 

$

5,064

 

 

$

1,899

 

Total research and development expenses

 

$

62,428

 

 

$

82,931

 

 

24


Research and development expenses for the nine months ended June 30, 2026 decreased by $20.5 million compared to the same period in 2025.

Virology

The costs in our virology program decreased by $35.9 million due to the timing of our clinical trials in our RSV program.

Immunology

The costs in our immunology programs increased by $12.2 million due to scale-up and IND-enabling activities for such programs.

Other Programs

Other program costs increased by $3.2 million as we advanced early-stage drug discovery efforts.

General and administrative expenses

General and administrative expenses decreased by $6.2 million for the nine months ended June 30, 2026 compared to the same period in 2025. The decrease was primarily due to lower stock-based compensation expenses during the nine months ended June 30, 2026 and a decrease in legal expenses related to our patent infringement suit against Pfizer for the ’953 Patent.

Other income (expense)

Changes in components of other income (expense) were as follows:

Interest expense

Interest expense increased by $5.2 million for the nine months ended June 30, 2026, as compared to the same period in 2025 due to an increase in forecasted royalties arising from AbbVie’s product sales under the AbbVie Agreement and corresponding royalty payment to OMERS arising from such sales pursuant to our OMERS royalty sales agreement.

Interest and investment income, net

Interest and investment income, net, decreased by $1.0 million for the nine months ended June 30, 2026, as compared to the same period in 2025. The decrease was due to lower interest rates year over year.

Income tax (expense) benefit

The income tax expense of $0.1 million during the nine months ended June 30, 2026 was primarily due to state income taxes. The income tax benefit of $1.7 million during the nine months ended June 30, 2025 was primarily due to an additional federal income tax refund from a net operating loss carryback of $0.9 million. We received the federal income tax refund of $33.8 million, inclusive of interest, in April 2025.

Liquidity and Capital Resources

We fund our operations with cash flows from our retained portion of our royalty revenue and our existing financial resources. At June 30, 2026, our principal sources of liquidity were cash and cash equivalents and short-term and long-term marketable securities of $211.5 million.

On July 2, 2026, we entered into an Open Market Sale AgreementSM with Jefferies LLC, as sales agent, under which we may offer and sell shares of our common stock, having an aggregate offering price of up to $75.0 million, from time to time through Jefferies under the at-the-market (ATM) facility. We have not issued any shares of common stock under this sale agreement through the filing date of this Form 10-Q.

The following table shows a summary of our cash flows:

 

 

 

 

 

 

 

Nine Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

 

(in thousands)

 

Cash provided by (used in):

 

 

 

 

 

 

Operating activities

 

$

(28,827

)

 

$

(12,783

)

Investing activities

 

 

(21,351

)

 

 

38,051

 

Financing activities

 

 

51,299

 

 

 

(18,297

)

Net increase in cash, cash equivalents and restricted cash

 

$

1,121

 

 

$

6,971

 

 

25


 

Net cash used in operating activities

Cash used in operating activities was $28.8 million for the nine months ended June 30, 2026 as compared to cash used in operating activities of $12.8 million for the same period in 2025. Our cash used in operating activities was lower in 2025 primarily due to receipt of a $33.8 million income tax refund in April 2025, partially offset by lower research and development payments in 2026.

Net cash (used in) provided by investing activities

Cash used in investing activities was $21.4 million for the nine months ended June 30, 2026 as compared to cash provided by investing activities of $38.1 million for the same period in 2025. Our cash used in investing activities increased by $59.4 million, driven by the timing of purchases and maturities of marketable securities in 2026 compared to 2025.

Net cash provided by (used in) financing activities

Cash provided by financing activities was $51.3 million for the nine months ended June 30, 2026 as compared to cash used in financing activities of $18.3 million for the same period in 2025. Our cash provided by financing activities increased by $69.6 million, driven primarily by proceeds received from our public offering which closed in October 2025.

Funding Requirements

As of June 30, 2026, we had $211.5 million in cash, cash equivalents and short-term and long-term marketable securities. Based on our operating plan, we believe that our existing cash, cash equivalents and short-term and long-term marketable securities as of June 30, 2026, as well as the cash flows from our retained portion of future HCV royalties, will enable us to fund our operating expenses and capital expenditure requirements into fiscal 2029. However, our projection of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

Our future capital requirements are difficult to forecast and will depend on many factors, including:

the number and characteristics of our research and development programs;
the scope, progress, results and costs of researching and developing our product candidates on our own, including conducting advanced clinical trials;
our ability to establish new collaborations, licensing or other arrangements, if any, and the financial terms of such arrangements;
the amount of our retained portion of royalties generated from MAVYRET/MAVIRET sales under our existing collaboration with AbbVie;
delays and additional expenses in our clinical trials;
the cost of manufacturing our product candidates for clinical development and any products we successfully commercialize independently;
opportunities to in-license or otherwise acquire new technologies and therapeutic candidates;
costs associated with prosecuting our patent infringement litigation regarding use of a coronavirus 3CL protease inhibitor in Paxlovid, Pfizer's antiviral treatment for COVID-19;
the timing of, and the costs involved in, obtaining regulatory approvals for any product candidates we develop independently;
the cost of commercialization activities, if any, of any product candidates we develop independently that are approved for sale, including marketing, sales and distribution costs;
the timing and amount of any sales of our product candidates, if any, or royalties thereon;
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patents, including any litigation costs and the outcomes of any such litigation; and
potential fluctuations in foreign currency exchange rates.

26


Off-Balance Sheet Arrangements

We do not engage in any off-balance sheet financing activities. We do not have any interest in entities referred to as variable interest entities, which include special purpose entities and other structured finance entities.

Contractual Obligations and Commitments

Facility Leases

As of the date of this report, we lease space in Watertown, Massachusetts, under two separate lease agreements with one landlord.

In May 2022, we entered into a ten-year lease for new laboratory and office space in Watertown, Massachusetts, adjacent to our 400 Talcott Avenue premises at Arsenal on the Charles at 4 Kingsbury Avenue since our lease for office and laboratory space at 500 Arsenal Street was to expire on September 1, 2027. The construction of the facility shell was completed and we gained access to the building to construct tenant improvements during the three months ended March 31, 2024. Upon gaining access to the 4 Kingsbury Avenue building, we capitalized a right-of-use asset and lease liability of approximately $32 million on our consolidated balance sheets which reflects our fixed base rent payments, net of approximately $15 million of a tenant improvement allowance provided by the landlord, over the 10-year term of the lease. The 4 Kingsbury Avenue lease ends on September 30, 2034.

In conjunction with the commencement of our lease at 4 Kingsbury Avenue, during the three months ended March 31, 2024, we adjusted our 500 Arsenal Street lease liability to shorten the expiration date from September 2027 to the date the 4 Kingsbury Avenue building became ready for our occupancy. This resulted in a decrease in the lease liability and right-of-use asset on our consolidated balance sheets by approximately $9.0 million. The rent commencement date for our 4 Kingsbury Avenue lease was September 12, 2024, and we moved into the space in November 2024, at which time our lease at 500 Arsenal Street expired.

The second lease for office space located at 400 Talcott Avenue commenced on September 24, 2018 for a term of six years. In May 2022, we amended this lease to expand the rented space and extend the lease term through June 1, 2034. We spent approximately $6.3 million in capital expenditures for the additional space, which primarily relate to tenant improvements. We received a tenant improvement allowance from the landlord of $2.5 million. In July 2024, we amended our lease agreement to confirm alignment with the lease end date of our 4 Kingsbury Avenue lease at September 30, 2034.

Total estimated minimum lease payments for the next 5 years and thereafter under our existing facility and leased equipment agreements are $2.1 million for the remainder of 2026, $8.7 million in 2027, $9.0 million in 2028, $9.3 million in 2029, $9.5 million in 2030, and $41.1 million thereafter.

OMERS Agreement

In April 2023, we entered into a royalty sale agreement with an affiliate of OMERS, pursuant to which we were paid a $200.0 million cash purchase price in exchange for 54.5% of our future quarterly royalty payments on net sales of MAVYRET/MAVIRET after June 30, 2023, through June 30, 2032, subject to a cap on aggregate payments equal to 1.42 times the purchase price.

The $200.0 million received in April 2023 was recognized on our condensed consolidated balance sheets as a liability which will be reduced by the payments made to OMERS over the term of the Agreement.

Preferred Stock

As of June 30, 2026, we had 1.9 million outstanding shares of Series 1 nonconvertible preferred stock, all of which we classified as a long-term liability on our consolidated balance sheet and recorded at fair value of $1.3 million. The fair value of the preferred stock was measured based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The fair value of these instruments represents less than 10% of liabilities as of June 30, 2026. The Series 1 nonconvertible preferred stock issued would require the payment of $2.0 million in the event of a qualifying merger or sale of the company.

Critical Accounting Policies

Our condensed consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions and conditions. See our 2025 Form 10-K for information about our critical accounting policies as well as a description of our other significant accounting policies. There have been no material changes to our critical accounting policies since the beginning of this fiscal year.

27


Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is set forth in Note 2 to the condensed consolidated financial statements included in this Form 10-Q.

28


ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

During the nine months ended June 30, 2026, there were no material changes to our market risk disclosures as set forth in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2025.

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures and Internal Control over Financial Reporting

Evaluation of Disclosure Controls and Procedures.

Our management, with the participation of the principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this quarterly report. Based on this evaluation, the principal executive officer and principal financial officer concluded that these disclosure controls and procedures are effective and designed to ensure that the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the requisite time periods.

Changes in Internal Control Over Financial Reporting.

There were no changes in our internal control over financial reporting that occurred during the three months ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

Information with respect to legal proceedings is included in Note 10 of the Notes to the Unaudited Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

 

ITEM 1A. RISK FACTORS

Our business faces significant risks and uncertainties. Certain factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the detailed discussion of risk factors included in our 2025 Form 10-K.

There have been no material changes to such risk factors during the three months ended June 30, 2026. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

ITEM 5. OTHER INFORMATION

Rule 10b5-1 Trading Arrangements. During the three months ended June 30, 2026, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-rule 10b5-1 trading arrangement,” as each term is defined in item 408(a) of Regulation S-K.

29


ITEM 6. EXHIBITS

 

 

 

 

 

Incorporated by Reference

 

 

Exhibit

Number

 

Exhibit Description

 

Form

 

Date

 

Exhibit

Number

 

File Number

 

Filed

Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

3.1

 

Restated Certificate of Incorporation of Enanta Pharmaceuticals, Inc.

 

8-K

 

03/28/2013

 

3.1

 

001-35839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3.2

 

Amended and Restated Bylaws of Enanta Pharmaceuticals, Inc. (as amended and restated in August 2015)

 

8-K

 

08/18/2015

 

3.2

 

001-35839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

31.1

 

Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.2

 

Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

32.1

 

Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema with embedded Linkbases document

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

 

 

 

 

 

Cover Page Interactive Data File (formatted as Inline XBRL with applicable Taxonomy Extension information contained in Exhibit 101).

 

 

 

 

 

 

 

 

 

X

 

30


ENANTA PHARMACEUTICALS, INC.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

ENANTA PHARMACEUTICALS, INC.

 

 

 

Date: August 12, 2026

 

 

/s/ Jay R. Luly, Ph.D.

 

 

Jay R. Luly, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

 

Date: August 12, 2026

 

 

/s/ Harry R. Trout III

 

 

Harry R. Trout III

Vice President, Finance

(Principal Financial Officer)

 

 

31