Form 8-K - Current report

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): August 6, 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 2.02. Results of Operations and Financial Condition.

On August 6, 2024, Protagonist Therapeutics, Inc. reported its financial results for the second quarter ended June 30, 2024. A copy of the press release titled “Protagonist Reports Second Quarter 2024 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 August 6, 2024, titled “Protagonist Reports Second Quarter 2024 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: August 6, 2024
	By:	/s/ Asif Ali
		Asif Ali
		Chief Financial Officer

Exhibit 99.1

Protagonist Reports Second Quarter 2024 Financial Results and Provides Corporate Update

JNJ-2113 Phase 3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in moderate-to-severe plaque psoriasis expected to complete the primary endpoint portion of the studies in Q4 2024

JNJ-2113 Phase 2b ANTHEM clinical trial in moderate-to-severe ulcerative colitis expected to complete the primary endpoint portion of the study in Q4 2024

Rusfertide Phase 2 REVIVE study long-term follow-up data in polycythemia vera presented at European Hematology Association (EHA) 2024; study showed durable hematocrit control, decreased phlebotomy use, long-term tolerability and no new safety signals

Rusfertide topline results from the 32-week primary endpoint of the Phase 3 VERIFY study expected in Q1 2025

Cash, cash equivalents and marketable securities of $595.4M as of June 30, 2024, anticipated to provide cash runway through end of 2027

NEWARK, Calif., August 6, 2024 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the Company”) today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.

“During the second quarter of 2024 our team made tremendous strides in the late-stage clinical development of rusfertide and also in leveraging our proprietary discovery platform for early-stage, but highly differentiated, oral peptides-based discovery programs,” said Dinesh V. Patel, Ph.D., the Company’s President and CEO. “We presented updated long-term data from the REVIVE Phase 2 trial at EHA that reaffirms rusfertide’s durability of positive response in polycythemia vera, and we look forward to the Phase 3 VERIFY 32-week primary endpoint readout in Q1 2025. We are excited at the prospect of introducing multiple new development candidates in a variety of indications over the next 12 months where oral peptides would offer a strong differentiation versus existing options. Additionally, our addition to the S&P SmallCap 600^® index highlights the value Protagonist brings to shareholders and provides additional visibility within the investment community.”

Dr. Patel continued, “We are also very pleased with the rapid pace of enrollment in the five different ongoing Phase 3 trials of JNJ-2113 in psoriasis and the Phase 2b study in ulcerative colitis. With the primary endpoint portion of the ICONIC-LEAD in moderate-to-severe plaque psoriasis, ICONIC-TOTAL in psoriasis in special body regions, and ANTHEM in ulcerative colitis studies all expected to be completed this year, we look forward to uncovering the potential and differentiation of JNJ-2113, the first and only targeted oral IL-23 receptor antagonist (IL23Ri) peptide.”

Second Quarter 2024 Recent Developments and Upcoming Milestones

Dr. Newman Yeilding joined the Protagonist executive team as Chief Scientific Advisor, effective August 1^st. His 20-plus years of work experience, including seven years as the Head of Immunology at Janssen Pharmaceutical Companies of Johnson & Johnson, covered a broad range of research and development (R&D) responsibilities in the inflammation and immunomodulatory (I&I) diseases space including Rheumatology, Gastroenterology, Dermatology and Pediatric Development. Dr. Yeilding’s insights in the field and guidance on the expansion of the Company’s discovery platform and R&D pipeline will be of significant value.

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)

Updated long-term (up to 3-year) follow-up data from the REVIVE Phase 2 study in PV was presented at the EHA 2024 Congress. The presentation showed durability of response as measured by hematocrit (Hct) control (< 45%), decreased phlebotomy use, long-term tolerability, and no new safety signals.

The Company expects to announce top-line data for the VERIFY study’s 32-week primary efficacy endpoint in PV in Q1 of 2025.

JNJ-2113: Oral IL-23 Receptor Antagonist for Psoriasis (PsO) and Ulcerative Colitis (UC)

On July 30, 2024, data summarizing preclinical findings and its translational correlation with phase 1 clinical data on JNJ-2113 were published in the journal Scientific Reports, a Nature publication and the fifth most-cited journal in the world.

The 16-week primary endpoint portion of the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies in PsO¹, which began in Q4 of 2023, are expected to be completed in Q4 2024.

The 12-week primary endpoint portion of the Phase 2b ANTHEM multicenter, randomized, placebo-controlled, dose-ranging study of JNJ-2113 for the treatment of moderately-to-severely active UC²is expected to be completed in Q4 2024.

The 16-week primary endpoint portion of the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies in PsO³, evaluating the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib is expected to be completed in Q1 2025.

The primary endpoint portion of the Phase 3 in pustular and erythrodermic psoriasis⁴ evaluating the safety and efficacy of JNJ-2113 in approximately 16 subjects compared with placebo is expected to be completed in Q1 2025.

Discovery Programs

Protagonist is pursuing the discovery of novel oral peptides against various clinically validated biological targets in hematology, I&I diseases, and obesity and related indications.

The Company announced an oral IL-17 discovery program in January 2024 with a development candidate expected to be announced by end of 2024.

Protagonist is also anticipating the nomination of a development candidate in the hematology space and an oral peptide-based development candidate in the obesity program by the middle of 2025.

¹ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)

²ANTHEM (NCT06049017)

³ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)

⁴Pustular/Erythrodermic (NCT06295692)

Second Quarter 2024 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2024, were $595.4 million as compared to $341.6 million as of December 31, 2023. The increase reflects the receipt in April 2024 of the upfront payment from the Takeda Worldwide License and Collaboration Agreement for rusfertide (the “Collaboration Agreement”) entered in Q1 2024.

	Three Months Ended						Six Months Ended
	June 30,						June 30,
(in thousands, except per share amounts)	2024			2023			2024		2023
License and collaboration revenue	$	4,167		$	-		$	259,120	$	-
Research and development expense	$	33,520		$	33,182		$	67,254	$	60,598
General and administrative expense	$	9,440		$	9,172		$	24,350	$	17,777
Net income (loss)	$	(30,616	)	$	(38,460	)	$	176,724	$	(72,185	)
Basic earnings (loss) per share	$	(0.50	)	$	(0.68	)	$	2.89	$	(1.34	)
Diluted earnings (loss) per share	$	(0.50	)	$	(0.68	)	$	2.77	$	(1.34	)

License and Collaboration Revenue: The Collaboration Agreement included a nonrefundable upfront payment of $300.0 million of which we recognized $255.0 million during the first quarter of 2024. The remaining $45.0 million was recorded as deferred revenue to be recognized over time as the Company satisfies its performance obligation to complete the ongoing Phase 3 VERIFY trial for rusfertide.

During the second quarter of 2024, we recognized $4.2 million of this deferred revenue balance as revenue based on costs incurred in the quarter compared to the total budget for this performance obligation. License and collaboration revenue of $259.1 million for the six months ended June 30, 2024, is comprised of: (i) $255.0 million of the $300.0 million upfront cash payment for the Takeda Collaboration Agreement recorded in the first quarter of 2024 and (ii) the $4.2 million recorded as revenue during the second quarter of 2024.

Research and Development ("R&D") Expenses: The increase of $6.7 million in R&D expenses for the six months ended June 30, 2024 from the prior year period was primarily due to increases in drug discovery and pre-clinical research expenses.

General and Administrative ("G&A") Expenses: The increase in G&A expenses for the six months ended June 30, 2024 of $6.6 million from the prior year period was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda collaboration and an increase of approximately $2.0 million in stock-based compensation and other personnel-related expenses.

Net Income (Loss): Net loss was ($30.6) million, or ($0.50) per basic and diluted share, for the three months ended June 30, 3024, as compared to a net loss of ($38.5) million, or ($0.68) per basic and diluted share, for the three months ended June 30, 2023. Net income was $176.7 million, or $2.89 per basic share and $2.77 per diluted share, for the six months ended June 30, 2024, as compared to a net loss of ($72.2) million, or ($1.34) per basic and diluted share, for the six months ended June 30, 2023.

About Protagonist

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Johnson & Johnson (JNJ) scientists jointly discovered JNJ-2113 as part of Protagonist's Interleukin-23 receptor (IL-23R) antagonist collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. JNJ-2113 is currently being pursued in five Phase 3 studies in psoriasis, and a Phase 2b study in ulcerative colitis. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program for polycythemia vera (PV). The randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were published in The New England Journal of Medicine in February 2024. The open-label extension (OLE) component of REVIVE has also been completed and is followed by an additional 2-year long-term extension (LTE) THRIVE study. Enrollment has been completed in the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 JNJ-2113 and rusfertide, the timing of JNJ-2113 and rusfertide clinical trials, and timing of developments in our discovery programs. 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 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 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

PROTAGONIST THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(Amounts in thousands except share and per share data)

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2024			2023			2024			2023
License and collaboration revenue	$	4,167		$	-		$	259,120		$	-
Operating expenses:
Research and development ⁽¹⁾		33,520			33,182			67,254			60,598
General and administrative ⁽¹⁾		9,440			9,172			24,350			17,777
Total operating expenses		42,960			42,354			91,604			78,375
Income (loss) from operations		(38,793	)		(42,354	)		167,516			(78,375	)
Interest income		7,404			3,913			11,780			6,404
Other income (expense), net		97			(19	)		78			(214	)
Income (loss) before income tax benefit (expense)		(31,292	)		(38,460	)		179,374			(72,185	)
Income tax benefit (expense)		676			-			(2,650	)		-
Net income (loss)	$	(30,616	)	$	(38,460	)	$	176,724		$	(72,185	)
Net income (loss) per share, basic	$	(0.50	)	$	(0.68	)	$	2.89		$	(1.34	)
Net income (loss) per share, diluted	$	(0.50	)	$	(0.68	)	$	2.77		$	(1.34	)
Weighted-average shares used to compute net income (loss) per share, basic		61,305,289			56,775,742			61,080,489			53,691,965
Weighted-average shares used to compute net income (loss) per share, diluted		61,305,289			56,775,742			63,909,633			53,691,965

(1) Amount includes non-cash stock-based compensation expense.

PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation

(In thousands)

	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Research and development	$	5,097	$	4,809	$	10,385	$	9,391
General and administrative		3,847		3,534		7,911		6,536
Total stock-based compensation expense	$	8,944	$	8,343	$	18,296	$	15,927

PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)

	June 30,			December 31,
	2024			2023
Cash, cash equivalents and marketable securities	$	595,444		$	341,617
Receivable from collaboration partner		43			10,000
Working capital		529,347			334,303
Total assets		614,629			357,951
Accumulated deficit		(438,986	)		(615,710	)
Total stockholders' equity		541,324			336,677

Cover	Aug. 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 06, 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
Local Phone Number	474-0170
Written Communications	false
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