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Continued execution of Phase 3 VERIFY study of rusfertide in polycythemia vera
Arturo Molina, M.D., M.S. named Chief Medical Officer, providing medical, clinical development, and strategic leadership to the rusfertide clinical development program
Three rusfertide poster presentations to be shared at the 64th Annual Meeting and Exposition of the American Society of Hematology (ASH) in December
NEWARK, Calif., Nov. 8, 2022 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.
"Continued execution of the Phase 3 VERIFY global clinical development program of rusfertide in polycythemia vera remains our top corporate priority," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Rusfertide has the potential to transform the current treatment paradigm for PV, dramatically improving patients' lives. The enthusiasm we have observed around rusfertide, among patients and physicians alike, reinforces our commitment to advancing this important drug candidate as rapidly as possible."
Dr. Patel continued, "We are pleased to have recently announced a new Chief Medical Officer, Dr. Arturo Molina, a renowned hematologist-oncologist and a successful drug developer. Dr. Molina will focus on providing medical and operational leadership to our rusfertide clinical development program.
"Our Janssen-partnered asset, PN-235 (JNJ-77242113), an oral peptide interleukin 23 receptor (IL-23R) antagonist, is currently in multiple Phase 2 clinical studies to assess safety and efficacy in moderate-to-severe plaque psoriasis. We look forward to decision-driving results from these studies in the first half of next year. With important pending readouts for both rusfertide and PN-235, we expect the first half of 2023 to be a period of potential transformational value creation for Protagonist."
Third Quarter 2022 and Recent Developments
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Potential Indications
PN-235: Oral IL-23 Receptor Antagonist
PN-943: Oral, Gut-Restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)
Management and Operational Updates
Third Quarter 2022 Financial Results
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and PN-235 in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 stage of development. The VERIFY (Phase 3) and REVIVE (Phase 2) studies of rusfertide in polycythemia vera are ongoing. Protagonist owns all marketing rights to rusfertide.
Protagonist has partnered with Janssen Biotech, Inc. on the development of PN-235 (JNJ-77242113) in moderate-to-severe psoriasis and inflammatory bowel disease. PN-235 is currently in multiple studies in psoriasis, led by Janssen.
Protagonist is headquartered in Newark, California. For more information on Protagonist, please visit 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 our intentions or current expectations concerning, among other things, our expectations regarding enrollment in the rusfertide VERIFY Phase 3 trial, the potential benefits of rusfertide to patients, timing of PN-235 clinical trials and potential milestones related to PN-235, and our expected cash runway. 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, delays or difficulties in enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate our compounds or product candidates are unsafe or ineffective, dependence on third parties to conduct clinical studies and manufacture our products, our ability to earn milestone payments under our collaboration agreement with Janssen Biotech, the impact of the current COVID-19 pandemic on our discovery and development efforts, the impact of the ongoing military conflict in Ukraine and Russia on any future studies, 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.
PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (Unaudited) (Amounts in thousands except share and per share data) | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
License and collaboration revenue - related party | $ | - | $ | 10,286 | $ | 26,581 | $ | 18,740 | ||||
Operating expenses: | ||||||||||||
Research and development (1) | 25,402 | 36,956 | 96,331 | 87,633 | ||||||||
General and administrative (1) | 6,901 | 7,256 | 25,107 | 19,936 | ||||||||
Total operating expenses | 32,303 | 44,212 | 121,438 | 107,569 | ||||||||
Loss from operations | (32,303) | (33,926) | (94,857) | (88,829) | ||||||||
Interest income | 1,157 | 122 | 1,809 | 321 | ||||||||
Other expense, net | (86) | - | (151) | (136) | ||||||||
Net loss | $ | (31,232) | $ | (33,804) | $ | (93,199) | $ | (88,644) | ||||
Net loss per share, basic and diluted | $ | (0.64) | $ | (0.70) | $ | (1.90) | $ | (1.94) | ||||
Weighted-average shares used to compute net loss per share, basic and diluted | 49,107,639 | 47,987,184 | 48,971,329 | 45,705,782 |
(1) Amount includes non-cash stock-based compensation expense. |
PROTAGONIST THERAPEUTICS, INC. (In thousands) | |||||||||||
Three Months Ended | Nine Months Ended | ||||||||||
September 30, | September 30, | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
Research and development | $ | 3,858 | $ | 2,611 | $ | 11,290 | $ | 6,241 | |||
General and administrative | 2,092 | 2,164 | 7,400 | 5,130 | |||||||
Total stock-based compensation expense | $ | 5,950 | $ | 4,775 | $ | 18,690 | $ | 11,371 |
PROTAGONIST THERAPEUTICS, INC. (Unaudited) | |||||
September 30, | December 31, | ||||
2022 | 2021 | ||||
Cash, cash equivalents and marketable securities | $ | 267,437 | $ | 326,900 | |
Working capital | 239,863 | 296,720 | |||
Total assets | 282,174 | 347,695 | |||
Deferred revenue-related party | - | 1,601 | |||
Accumulated deficit | (502,561) | (409,362) | |||
Total stockholders' equity | 243,616 | 300,021 |
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SOURCE Protagonist Therapeutics, Inc.