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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Protagonist Therapeutics Inc | NASDAQ:PTGX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.55 | 2.15% | 26.09 | 24.00 | 27.61 | 26.585 | 25.745 | 26.20 | 355,731 | 01:00:00 |
NEWARK, Calif., Aug. 4, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") today reported its financial results for the second quarter ended June 30, 2021, and an overview of recent company progress.
"The second quarter of 2021 was one of enormous progress, achievement, and growth for our Company," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "In April, we announced completion of enrollment for our Phase 2 study of rusfertide in polycythemia vera, data from which supported the U.S. Food and Drug Administration's Breakthrough Therapy Designation. In mid-June, we shared updated results from this Phase 2 study in an oral presentation at the European Hematology Association's 2021 Virtual Congress. This data, from 63 patients, continues to demonstrate rusfertide's potential as the first-in-class, non-cytoreductive treatment option for this disease. The durability of effect and symptom improvements observed provided further support for the advancement of rusfertide into Phase 3 clinical development, expected to commence in early 2022."
Dr. Patel continued, "Looking ahead to the remainder of this year and into early 2022, Protagonist has multiple catalysts in view and underway. We intend to announce a third indication for rusfertide, beyond polycythemia vera and hereditary hemochromatosis. We look forward to sharing, for the first time, data from our clinical proof-of-concept study of rusfertide in hereditary hemochromatosis. In the fourth quarter, we are excited to share data from the completed Phase 2 study of rusfertide in polycythemia vera, meanwhile preparing diligently for the Phase 3 study. Finally, we remain intensely engaged in the successful execution of our Phase 2 study of PN-943 in ulcerative colitis and intend to share data from this study in the second quarter of 2022."
Second Quarter 2021 Recent Developments and Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin Antagonist for Ulcerative Colitis
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist Collaboration)
Second Quarter 2021 Financial Results
Financial Update
Financial Results
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary discovery technology platform.
Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis. Based on the feedback provided by the FDA and EU regulatory authorities, the Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.
The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC).
The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies.
Protagonist is headquartered in Newark, California. For further information, please visit 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, potential benefits of rusfertide for the treatment of PV, and commencement or completion of clinical trials and announcements of clinical data. 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, the impact of the current COVID-19 pandemic on our discovery and development efforts, 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 | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||
License and collaboration revenue - related party | $ | 2,265 | $ | 6,217 | $ | 8,454 | $ | 9,864 | ||||
Operating expenses: | ||||||||||||
Research and development (1) | 26,432 | 20,257 | 50,677 | 39,025 | ||||||||
General and administrative (1) | 6,715 | 4,177 | 12,680 | 8,753 | ||||||||
Total operating expenses | 33,147 | 24,434 | 63,357 | 47,778 | ||||||||
Loss from operations | (30,882) | (18,217) | (54,903) | (37,914) | ||||||||
Interest income | 97 | 207 | 199 | 733 | ||||||||
Interest expense | — | (209) | — | (452) | ||||||||
Loss on early repayment of debt | — | (585) | — | (585) | ||||||||
Other (expense) income, net | (57) | 512 | (136) | 22 | ||||||||
Loss before income tax expense | (30,842) | (18,292) | (54,840) | (38,196) | ||||||||
Income tax expense | — | (1,129) | — | (1,305) | ||||||||
Net loss | $ | (30,842) | $ | (19,421) | $ | (54,840) | $ | (39,501) | ||||
Net loss per share, basic and diluted | $ | (0.69) | $ | (0.59) | $ | (1.23) | $ | (1.31) | ||||
Weighted-average shares used to compute net loss per share, basic and diluted | 44,964,637 | 32,799,691 | 44,546,172 | 30,251,805 |
(1) Amount includes non-cash stock-based compensation expense. |
Stock-based Compensation (Unaudited) | |||||||||||
(In thousands) | |||||||||||
Three Months Ended | Six Months Ended | ||||||||||
June 30, | June 30, | ||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
Research and development | $ | 2,155 | $ | 1,026 | $ | 3,630 | $ | 2,092 | |||
General and administrative | 1,781 | 970 | 2,966 | 1,952 | |||||||
Total stock-based compensation expense | $ | 3,936 | $ | 1,996 | $ | 6,596 | $ | 4,044 |
PROTAGONIST THERAPEUTICS, INC. | |||||
Selected Consolidated Balance Sheet Data | |||||
(In thousands) | |||||
June 30, | December 31, | ||||
2021 | 2020 | ||||
Cash, cash equivalents and marketable securities | $ | 380,402 | $ | 307,809 | |
Working Capital | 328,845 | 275,365 | |||
Total assets | 404,232 | 324,468 | |||
Deferred revenue-related party | 2,009 | 14,477 | |||
Accumulated deficit | (338,651) | (283,811) | |||
Total stockholders' equity | 357,447 | 279,606 |
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SOURCE Protagonist Therapeutics, Inc.
Copyright 2021 PR Newswire
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