Positive topline results from the Phase 2b FRONTIER 1 study of JNJ-2113 (formerly PN-235), the first and only IL-23 receptor antagonist oral peptide drug candidate for the treatment of moderate-to-severe plaque psoriasis, presented at the World Congress of Dermatology.
JNJ-2113 now advances toward a Phase 3 study in moderate-to-severe psoriasis and a Phase 2b study in ulcerative colitis.
Positive data from the randomized withdrawal portion of the Phase 2 REVIVE study of rusfertide in polycythemia vera (PV) presented as a late breaker at the annual Congress of the European Hematology Association (EHA2023); the global Phase 3 VERIFY study continues, with sites recruiting globally.
NEWARK, CA / ACCESSWIRE / August 3, 2023 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.
"The second quarter of 2023 was transformative for Protagonist, marked by the disclosure of strongly positive data from FRONTIER 1, a Phase 2b study of JNJ-2113, at the World Congress of Dermatology, and the decision by our partner, Janssen, to move forward into a Phase 3 clinical program in psoriasis and a Phase 2b study in ulcerative colitis," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "JNJ-2113 is a first-in-class and only oral IL-23 receptor antagonist peptide that has the potential to lead the field of oral therapy for psoriasis. Today, a significant number of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies, and JNJ-2113 can potentially offer a highly convenient, effective and safe solution to a broad category of eligible individuals."
"We have also made impressive strides forward in the clinical development of our fully owned asset, rusfertide, in polycythemia vera," Dr. Patel continued. "The Phase 2 REVIVE study results were presented to a large audience as a late breaker at EHA2023. The Phase 3 VERIFY clinical trial is continuing to enroll study participants at sites globally, with enrollment completion projected by the end of the first quarter of 2024. Our cash position remains strong, with estimated cash runway through end of 2025. This estimate does not include the potential $200 million in milestones associated with a successful Phase 3 study, NDA filing, and approval of JNJ-2113 in psoriasis."
Q2 and Recent Corporate Highlights
Second Quarter 2023 Financial Results
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
License and collaboration revenue | $ | - | $ | 859 | $ | - | $ | 26,581 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development (1) | 33,182 | 34,611 | 60,598 | 70,929 | ||||||||||||
General and administrative (1) | 9,172 | 7,691 | 17,777 | 18,206 | ||||||||||||
Total operating expenses | 42,354 | 42,302 | 78,375 | 89,135 | ||||||||||||
Loss from operations | (42,354) | (41,443) | (78,375) | (62,554) | ||||||||||||
Interest income | 3,913 | 484 | 6,404 | 652 | ||||||||||||
Other expense, net | (19) | (78) | (214) | (65) | ||||||||||||
Net loss | $ | (38,460) | $ | (41,037) | $ | (72,185) | $ | (61,967) | ||||||||
Net loss per share, basic and diluted | $ | (0.68) | $ | (0.84) | $ | (1.34) | $ | (1.27) | ||||||||
Weighted-average shares used to compute net loss per share, basic and diluted | 56,775,742 | 49,049,902 | 53,691,965 | 48,902,047 | ||||||||||||
PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation (Unaudited)
(In thousands)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Research and development | $ | 4,809 | $ | 4,106 | $ | 9,391 | $ | 7,432 | ||||||||
General and administrative | 3,534 | 2,699 | 6,536 | 5,308 | ||||||||||||
Total stock-based compensation expense | $ | 8,343 | $ | 6,805 | $ | 15,927 | $ | 12,740 |
PROTAGONIST THERAPEUTICS, INC.
(Unaudited)
Selected Consolidated Balance Sheet Data
(In thousands)
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Cash, cash equivalents and marketable securities$ | $ | 313,401 | $ | 237,355 | ||||
Working capital | 290,543 | 211,898 | ||||||
Total assets | 320,466 | 247,928 | ||||||
Accumulated deficit | (608,940) | (536,755) | ||||||
Total stockholders' equity | 294,068 | 215,608 |
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 scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen 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 Phase 2 REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 clinical development of JNJ-2113, our potential receipt of milestone and royalty payments under our collaboration agreement with Janssen Biotech, Inc., our forecasted cash runway and our expectations regarding enrollment in the REVIVE Phase 3 trial. 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 Janssen Biotech, Inc., 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.
Contact
Jami Taylor
Email: j.taylor@ptgx-inc.com
SOURCE: Protagonist Therapeutics, Inc.