Form 8-K

8-K — Protagonist Therapeutics, Inc

Accession: 0001104659-26-055629

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0001377121

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section

13 or 15(d)

of the Securities

Exchange Act of 1934

Date of Report (Date of earliest event

reported): May 5, 2026

PROTAGONIST THERAPEUTICS, INC.

(Exact name of registrant as specified

in its charter)

Delaware

001-37852

98-0505495

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

Protagonist Therapeutics, Inc.

7707 Gateway Blvd., Suite 140

Newark, California 94560-1160

(Address of principal executive offices,

including zip code)

(510) 474-0170

(Registrant’s telephone number, including

area code)

Not Applicable

(Former name or former address, if changed

since last report.)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 $0.00001

PTGX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging

growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities

Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ¨

Item 2.02. Results of Operations

and Financial Condition.

On May 5, 2026, Protagonist Therapeutics,

Inc. reported its financial results for the quarter ended March 31, 2026. A copy of the press release titled “Protagonist Reports

First Quarter 2026 Financial Results and Provides Corporate Update” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and

is incorporated herein by reference.

Item

9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press release, dated May 5, 2026, titled “Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate Update.”

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

The information in this report, including the exhibit hereto, shall

not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise

subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein

and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission

made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language

in such filing.

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 hereunto duly authorized.

Protagonist Therapeutics, Inc.

Dated: May 5, 2026

By:

/s/ Asif Ali

Asif Ali

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613550d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Protagonist Reports First Quarter 2026 Financial

Results and Provides Corporate Update

ICOTYDE™ (icotrokinra) approved by FDA

in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties

of 6% to 10% and is eligible for up to $580 million in future milestone payments

Rusfertide NDA accepted and granted Priority

Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026

Protagonist exercised its rusfertide opt-out

right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional

$200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties

ranging from 14% to 29%

PN-881 (oral IL-17 antagonist peptide) Phase

1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist)

Phase 1 initiation expected in mid-2026 and Q1 2027, respectively

Cash, cash equivalents and marketable securities

of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028

NEWARK,

Calif., May 5, 2026 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or

“the Company”) today reported financial results for the first quarter ended March 31, 2026, and provided a corporate

update.

“The first quarter of 2026 marked a

series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide,

and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477,” said Dinesh V. Patel, Ph.D., the Company’s

President and Chief Executive Officer. “These accomplishments, together with the additional financial resources afforded by our

rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful

near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal

discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time.”

First

Quarter 2026 Recent Developments and Upcoming Milestones

Rusfertide

March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted

Priority Review. The application is supported by data from the positive

32-week primary analysis and 52-week results from

the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term

extension THRIVE study. The FDA set a PDUFA goal date in August 2026.

On April 28, Protagonist announced that it exercised its right

to opt out of the U.S. profit and loss sharing arrangement under the terms of its collaboration agreement with Takeda for rusfertide.

The opt-out election triggers a $200 million payment to Protagonist, with an additional $200 opt-out fee and a separate $75 million milestone

for FDA approval of rusfertide. The opt-out election also increases downstream economics payable to Protagonist, including up to $775

million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average

royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion.

ICOTYDE™

(icotrokina)

March 18, Protagonist announced that Johnson & Johnson received U.S. Food and Drug Administration approval

for ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh

at least 40 kg and are candidates for systemic therapy or phototherapy. The FDA approval triggered a $50 million milestone payment to

Protagonist in the first quarter of 2026. Under the collaboration, Protagonist remains eligible to receive up to $580 million in potential

additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales with an approximate

7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to the incremental annual sales above $4

billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis

March 28, Protagonist announced presentation of new one-year Phase 3 ICOTYDE results at the 2026 American Academy

of Dermatology Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further supported the potential of

ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis, demonstrating durable efficacy and a

favorable safety profile in a once-daily pill.

Wholly-Owned Clinical and Discovery Programs

· PN-881 (oral IL-17 antagonist peptide): The Company expects completion of Phase 1 study by mid-2026 and initiation of a Phase 2 study

by end of 2026.

· PN-477 (triple-G GLP/GIP/GCG agonist peptide): Phase 1 initiation of PN-477sc and PN-477o anticipated in mid-2026 and Q1 2027, respectively.

· PN-458 (dual GLP/GIP agonist peptide): IND-enabling studies in progress with PN-458sc and PN-458o

· PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies in progress

· Discovery: Oral IL-4Rα antagonist and amylin oral mono/poly agonists are high-priority discovery programs.

First Quarter 2026 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2026,

were $620.3 million as compared to $646.0 million as of December 31, 2025.

Three Months Ended

March 31,

2026

2025

(in thousands, except per share amounts)

(Unaudited)

License and collaboration revenue

$ 56,368

$ 28,321

Research and development expense

$ 46,739

$ 35,893

General and administrative expense

$ 13,277

$ 11,738

Income tax benefit

$ 1,502

$ -

Net income (loss)

$ 3,783

$ (11,655 )

Basic earnings (loss) per share

$ 0.06

$ (0.19 )

Diluted earnings (loss) per share

$ 0.05

$ (0.19 )

· License and Collaboration Revenue: License and collaboration revenue of $56.4 million for the period ended March 31, 2026

consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated

to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from

Takeda for rusfertide clinical trial supplies. License and collaboration revenue of $28.3 million for the period ended March 31,

2025 consisted of (i) $22.8 million related to proportional recognition of a $25.0 million milestone earned in Q1 2025, and (ii) $5.5

million allocated to development services provided by us under the agreement during the period.

· Research and Development ("R&D") Expense: The increase in R&D expense from the prior year period was primarily

due to increases related to our Phase 1 study for PN-881 and pre-clinical and drug discovery research expenses, including our obesity

product candidates, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.

· General and Administrative ("G&A") Expense: The increase in G&A expense from the prior year period was primarily

due to an increase in personnel-related expenses, including wages and benefits and stock-based compensation.

· Income Tax Benefit: Income tax benefit was $1.5 million for the period ended March 31, 2026 and included a discrete credit

for stock-based compensation expense specific to the current quarter.

· Net Income (Loss): Net income was $3.8 million, or $0.06 per basic share and $0.05 per diluted share, for the first quarter

of 2026 as compared to net loss of $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025.

About Protagonist

Protagonist

Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables

de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near

commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first

and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026,

is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is

in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn’s disease. ICOTYDE

was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the

development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization.

Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class

hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the

treatment polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs

addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists,

an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.

Cautionary Note on Forward-Looking

Statements

This

press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform

Act of 1995. Forward-looking statements include statements regarding potential revenue from the Company's collaborations with Johnson &

Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company’s discovery and clinical

pipeline. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe,"

"may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking

statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events

to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates,

our ability to earn milestone and royalty payments under our collaboration agreements with Janssen and Takeda, our ability to use and

expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates,

our ability to operate in a competitive industry and compete successfully against competitors, and our ability to obtain and adequately

protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting

our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk

Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and

Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial

condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements

contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press

release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise,

after the date of this press release.

Investor Relations Contact

Corey Davis, Ph.D.

LifeSci Advisors

cdavis@lifesciadvisors.com

+1 212 915 2577

Media Relations Contact

Virginia Amann

ENTENTE Network of Companies

virginiaamann@ententeinc.com

+1 833 500 0061 ext 1

PROTAGONIST THERAPEUTICS, INC.

Consolidated Statements of Operations

(Amounts in thousands except share and per share

data)

Three Months Ended

March 31,

2026

2025

License and collaboration revenue

$ 56,368

$ 28,321

Operating expense:

Research and development (1)

46,739

35,893

General and administrative (1)

13,277

11,738

Total operating expense

60,016

47,631

Loss from operations

(3,648 )

(19,310 )

Interest income

5,876

7,573

Other income, net

Income (loss) before income tax benefit

2,281

(11,655 )

Income tax benefit

1,502

Net income (loss)

$ 3,783

$ (11,655 )

Net income (loss) per share, basic

$ 0.06

$ (0.19 )

Net income (loss) per share, diluted

$ 0.05

$ (0.19 )

Weighted-average shares used to compute net income (loss) per share, basic

65,087,847

62,963,806

Weighted-average shares used to compute net income (loss) per share, diluted

70,492,618

62,963,806

(1) Amount

includes non-cash stock-based compensation expense.

Stock-based

Compensation

(In thousands)

Three Months Ended

March 31,

2026

2025

Research and development

$ 7,769

$ 7,991

General and administrative

6,750

5,811

Total stock-based compensation expense

$ 14,519

$ 13,802

PROTAGONIST THERAPEUTICS, INC.

Selected Consolidated Balance Sheet Data

(In thousands)

March 31,

December 31,

2026

2025

Cash, cash equivalents and marketable securities

$ 620,334

$ 646,002

Working capital

578,906

532,133

Total assets

697,459

668,188

Deferred revenue

6,282

9,550

Accumulated deficit

(466,888 )

(470,671 )

Total stockholders' equity

655,473

614,707

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