PTGX Protagonist Therapeutics Inc

 

 

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): November 13, 2024

 

 

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 1.01. Entry into a Material Definitive Agreement

 

On November 13, 2024, Protagonist Therapeutics, Inc. (the “Company”) and Janssen Biotech, Inc., a Pennsylvania corporation (“Janssen”) entered into an amendment (the “Amendment”) to their amended and restated License and Collaboration Agreement dated July 27, 2021 (the “Collaboration Agreement”).

 

The Amendment:

 

(a) increases the milestone payment set forth in Section 7.3.1(D) (for a Phase 3 clinical trial for any Licensed Product for any indication meeting its primary endpoint) by $50 million, from $115 million to $165 million;

 

(b) eliminates the $35 million milestone payment in Section 7.3.1(E) (for acceptance of filing of an NDA by the FDA for use of Licensed Product in any indication); and

 

(c) eliminates the $15 million milestone payment in Section 7.3.1(L) (for dosing of the 3^rd patient in the first Phase 3 clinical trial of a Licensed Product for a second indication).

 

The $165 million milestone now payable pursuant to Section 7.3.1(D) of the Collaboration Agreement has been earned as a result of the Phase 3 clinical trial results described in the press release attached hereto as Exhibit 99.1. Accordingly, the Amendment has the effect of accelerating the $35 million and $15 million milestone payments set forth in Sections 7.3.1(E) and 7.3.1(L) of the Collaboration Agreement.

 

Item 8.01. Other Events

 

On November 18, 2024, the Company issued a press release related to Phase 3 clinical study results for icotrokinra (JNJ-2113, formerly PN-235), which is a Licensed Product under the Collaboration Agreement. The press release is attached hereto as Exhibit 99.1.

 

Item 9.01  Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release, dated November 18, 2024, titled “Protagonist announces positive topline results from Phase 3 ICONIC studies of icotrokinra (JNJ-2113) in plaque psoriasis, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor”
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

The information in Item 8.01 of 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 in Item 8.01 of this report 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: November 18, 2024
	By:	/s/ Asif Ali
		Asif Ali
		Chief Financial Officer

 

 

Exhibit 99.1

 

 

Protagonist announces positive topline results from Phase 3 ICONIC studies of icotrokinra (JNJ-2113) in plaque psoriasis, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor

 

ICONIC-LEAD achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16; 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24

 

ICONIC-TOTAL achieved its primary endpoint of IGA score of 0 or 1 at week 16 in patients with plaque psoriasis in difficult-to-treat areas

 

Protagonist has earned a $165 million milestone under the terms of recently amended agreement, inclusive of $50 million in accelerated payments

 

NEWARK, Calif. – November 18, 2024 – Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) today announced positive topline results from its collaboration with Johnson & Johnson, in ICONIC-LEAD¹ and ICONIC-TOTAL², two pivotal Phase 3 investigational studies of icotrokinra (JNJ-2113, formerly PN-235), the first-in-class targeted oral peptide that selectively blocks the IL-23 receptor, in individuals 12 years of age and older with moderate to severe plaque psoriasis (PsO).

 

In the ICONIC-LEAD study, once-daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (64.7%) of patients treated with icotrokinra achieved IGA³ scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90⁴, compared to 8.3% and 4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and 64.9% achieving PASI 90. Safety data was found to be consistent with the Phase 2 FRONTIER 1 and 2 studies. A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16. In addition, positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.

 

¹ ICONIC-LEAD (NCT06095115) is a Phase 3 randomized controlled trial (RCT) to evaluate the safety and efficacy of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 684 patients, including 66 adolescents.

² ICONIC-TOTAL (NCT06095102) is a Phase 3 to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. ICONIC-TOTAL enrolled 311 patients.

³ The IGA is a five-point scale with a severity ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease

⁴ The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness. PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.

 

 

"These positive Phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous Phase 2b FRONTIER-1 and -2 studies, highlighting icotrokinra’s potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis," said Dinesh V. Patel, PhD, President and CEO of Protagonist. “These results also continue to validate Protagonist’s innovative peptide technology platform and its effectiveness in creating highly differentiated new chemical entities to address unmet needs in various disease areas."

 

Comprehensive results from both ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.

 

Under the terms of the recently amended icotrokinra license and collaboration agreement with Johnson & Johnson, Protagonist has earned $165 million in milestone payments. These are inclusive of $115 million for successful completion of a Phase 3 study, a $35 million accelerated payment previously due upon acceptance of an NDA in psoriasis, and a $15 million accelerated payment previously due upon initiation of a Phase 3 study in a second indication.⁵ The $165 million payment, which the Company expects to receive in Q1 2025, has been earned under the agreement and is not refundable. The Company remains eligible for up to $630 million in future development and sales milestone payments, and tiered royalties of 6-10% on worldwide net sales.

 

Additional upcoming icotrokinra clinical studies and data anticipated in the first half of 2025 include:

 

·

Topline results for the Phase 2b ANTHEM multicenter, randomized, placebo-controlled, dose-ranging study of icotrokinra for the treatment of moderately to severely active ulcerative colitis6.

 

·

Topline results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies7, evaluating the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis.

 

·

An ICONIC-PsA psoriatic arthritis program evaluating icotrokinra in a Phase 3 study in psoriatic arthritis (PsA) will be initiated in the beginning of 2025.

 

“We’re very pleased with the ICONIC-LEAD and ICONIC-TOTAL Phase 3 results, and the decision of our partner to initiate a Phase 3 program for icotrokinra in psoriatic arthritis,” added Dr. Patel. “Our enthusiasm for icotrokinra is high heading into 2025, with upcoming Phase 2b ulcerative colitis results, presentation of ICONIC Phase 3 results at medical conferences, topline results from psoriasis superiority studies against deucravacitinib and a potential psoriasis NDA submission.”

 

⁵ See the Company’s Current Report on Form 8-K filed on November 18, 2024 for details related to the collaboration agreement amendment.

⁶ ANTHEM (NCT06049017)

⁷ ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)

 

 

About Protagonist

 

Protagonist Therapeutics is a late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist’s proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (JNJ-2113, formerly PN-235), is the first targeted oral peptide designed to selectively block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO and other IL-23-mediated diseases. Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells. Icotrokinra is licensed to Johnson & Johnson and is currently in Phase 3 development for psoriasis and is nearing completion of Phase 2b development for ulcerative colitis. Following icotrokinra’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera. Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17, hepcidin mimetic, and anti-obesity programs.

 

More 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 the potential benefits of icotrokinra, and the timing of icotrokinra publications and clinical trials. 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 payments under our collaboration agreements with Johnson & Johnson 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 that have greater resources than we do, 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

 

 

v3.24.3

Cover	Nov. 13, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Nov. 13, 2024
Entity File Number	001-37852
Entity Registrant Name	PROTAGONIST THERAPEUTICS, INC.
Entity Central Index Key	0001377121
Entity Tax Identification Number	98-0505495
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7707 Gateway Blvd.
Entity Address, Address Line Two	Suite 140
Entity Address, City or Town	Newark
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94560-1160
City Area Code	510
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Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.00001
Trading Symbol	PTGX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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