Worldwide collaboration agreement executed with Takeda Pharmaceuticals, including a $300 million upfront payment for rusfertide in polycythemia vera and other hematological indications
Cash runway extended through Q4 2027[1]
Two articles published in the New England Journal of Medicine reporting results from the Phase 2b FRONTIER 1 study of JNJ-2113 and the Phase 2 REVIVE study of rusfertide
Our Partner, Johnson & Johnson Innovative Medicine (formerly Janssen) initiated an expanded JNJ-2113 clinical development program with four Phase 3 studies in moderate-to-severe psoriasis and one Phase 2b study in moderately-to-severely active ulcerative colitis
Protagonist achieved $60 million in milestones in Q4 related to JNJ-2113
NEWARK, CA / ACCESSWIRE / February 27, 2024 / Protagonist Therapeutics (Nasdaq:PTGX) (“Protagonist” or “the Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“The fourth quarter of 2023 was an extremely busy and productive time for Protagonist,” said Dinesh V. Patel, Ph.D., the Company’s President and CEO. “Our novel hepcidin mimetic rusfertide was well represented at the American Society of Hematology (ASH) Annual Meeting in December, including an oral presentation of the long-term follow-up data from the Phase 2 REVIVE study showing durability of hematocrit control and no new safety signals. We look forward to completing enrollment of the Phase 3 VERIFY study by the end of Q1 2024, and potentially filing an NDA next year after completion of the 52-week study. We are extremely pleased to have joined hands with our new partner Takeda in preparation for the potential commercial launch of rusfertide.”
Dr. Patel continued: “The JNJ-2113 clinical development program is progressing and expanding in a very impressive way, with four Phase 3 psoriasis studies and a Phase 2b study in ulcerative colitis. We believe that JNJ-2113 has the potential to be a major part of the Inflammation & Immunology franchise. Internally, we continue to expand our discovery efforts and are evaluating novel oral peptides against validated biological pathways with the aim of achieving major differentiation against the current standards of care and addressing significant unmet needs in various disease indications. In drug discovery, we plan to announce an oral peptide IL-17 development candidate by year end, maximizing our presence with first-in-class drug candidates for diseases mediated by the IL-17/IL-23 pathway.”
Fourth Quarter 2023 Recent Developments and Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
JNJ-2113 (formerly PN-235): Oral IL-23 Receptor Antagonist
Discovery Programs
Fourth Quarter 2023 Financial Results
[1] Based on Cash, Cash Equivalents and Marketable Securities as of December 31, 2023, and including the $300m upfront payment expected from the worldwide collaboration agreement with Takeda Pharmaceuticals, but excluding all future milestones, including those expected with respect to JNJ-2113.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company’s proprietary technology platform. Protagonist and JNJ scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist’s Interleukin-23 receptor (IL-23R) collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company’s lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Rusfertide will be co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in January 2024. The agreement will be effective upon the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.
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, our expectations regarding the timing of enrollment completion in our clinical trial (VERIFY), filing of the rusfertide NDA, clinical development of JNJ-2113 and our ongoing IL-17 and other discovery research 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 agreement with JNJ, 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
+1 212 915 2577
cdavis@lifesciadvisors.com
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 | Twelve Months Ended | ||||||||||||||
|
December 31, | December 31, | ||||||||||||||
|
2023 | 2022 | 2023 | 2022 | ||||||||||||
License and collaboration revenue
|
$ | 60,000 | $ | – | $ | 60,000 | $ | 26,581 | ||||||||
Operating expenses:
|
||||||||||||||||
Research and development (1)
|
28,899 | 29,884 | 120,161 | 126,215 | ||||||||||||
General and administrative (1)
|
8,052 | 6,632 | 33,491 | 31,739 | ||||||||||||
Total operating expenses
|
36,951 | 36,516 | 153,652 | 157,954 | ||||||||||||
Income (loss) from operations
|
23,049 | (36,516 | ) | (93,652 | ) | (131,373 | ) | |||||||||
Interest income
|
4,242 | 2,251 | 14,898 | 4,060 | ||||||||||||
Other expense, net
|
44 | 71 | (201 | ) | (80 | ) | ||||||||||
Net income (loss)
|
$ | 27,335 | $ | (34,194 | ) | $ | (78,955 | ) | $ | (127,393 | ) | |||||
Net income (loss) per share, basic
|
$ | 0.45 | $ | (0.69 | ) | $ | (1.39 | ) | $ | (2.60 | ) | |||||
Net income (loss) per share, diluted
|
$ | 0.44 | $ | (0.69 | ) | $ | (1.39 | ) | $ | (2.60 | ) | |||||
Weighted-average shares used to compute net income (loss) per share, basic
|
60,387,606 | 49,252,633 | 56,763,559 | 49,042,232 | ||||||||||||
Weighted-average shares used to compute net income (loss) per share, diluted
|
61,796,205 | 49,252,633 | 56,763,559 | 49,042,232 | ||||||||||||
|
PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation
(In thousands)
|
Three Months Ended | Twelve Months Ended | ||||||||||||||
December 31, | December 31, | |||||||||||||||
|
2023 | 2022 | 2023 | 2022 | ||||||||||||
Research and development
|
$ | 3,890 | $ | 3,429 | $ | 17,061 | $ | 14,719 | ||||||||
General and administrative
|
2,711 | 2,083 | 12,232 | 9,483 | ||||||||||||
Total stock-based compensation expense
|
$ | 6,601 | $ | 5,512 | $ | 29,293 | $ | 24,202 | ||||||||
|
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
|
December 31, | December 31, | ||||||
|
2023 | 2022 | ||||||
Cash, cash equivalents and marketable securities$
|
$ | 341,617 | 237,355 | |||||
Working capital
|
334,303 | 211,898 | ||||||
Total assets
|
357,951 | 247,928 | ||||||
Accumulated deficit
|
(615,710 | ) | (536,755 | ) | ||||
Total stockholders’ equity
|
336,677 | 215,608 | ||||||
|
SOURCE: Protagonist Therapeutics, Inc.
View the original press release on accesswire.com
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