Full Press Release Details
Reports Second Quarter 2022 Financial Results and Provides Corporate Update
focus on Phase 3 VERIFY study of rusfertide in polycythemia vera (PV)
new, positive data from Phase 2 REVIVE study of rusfertide in PV at the 2022 ASCO Annual
Meeting and the EHA2022 Congress
cash position, with cash runway through end of 2024
Calif., August 4, 2022 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the
Company") today reported financial results for the second quarter ended June 30, 2022 and provided a corporate update.
continue to prioritize the development of rusfertide in polycythemia vera, driving the Phase 3 VERIFY study forward with a focus on
data readout with the cash we have on hand," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of
Protagonist. "Updated Phase 2 drug suspension and re-dosing data, recently presented at the 2022 ASCO and EHA conferences,
reaffirm rusfertide's potential to improve patients' lives and transform the treatment landscape for
continued, "Our diverse programs, including both partnered and fully owned assets, provide us with several opportunities to bring
new medicines forward to patients and create shareholder value. Our partner, Janssen, is pursuing multiple clinical studies of PN-235,
including two Phase 2 studies in moderate-to-severe plaque psoriasis. In parallel with partnership exploration for PN-943, we are engaging
with regulators for guidance on the next phase of clinical development. Our cash position remains strong, with runway through the end
of 2024. Protagonist's proprietary peptide technology platform confers fundamental strengths that will serve us well in the current environment and over the long term."
2022 Recent Developments
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
| The Company completed patient enrollment in the ongoing Phase 2 REVIVE study of rusfertide in PV in the first quarter of 2022, with a target of approximately 50 patients to be enrolled through the end of the randomized withdrawal portion of the study. | |
| Highlights of the Phase 2 REVIVE study were shared as an oral presentation by Ronald Hoffman, M.D. at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Q2. 2022. Dr. Hoffman is principal investigator of the Phase 2 REVIVE study, and the Albert A. and Vera G. List Professor of Medicine and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai. |
Oral IL-23 Receptor Antagonist
| o | FRONTIER 2, a long-term extension study; | |
| o | SUMMIT, a study of an oral tablet formulation of PN-235 for the treatment of moderate-to-severe plaque psoriasis; and |
Oral, Gut-restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)
2022 Financial Results
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide, PN-943, and PN-235 in different stages
of clinical development, all derived from the Company's proprietary technology platform. Rusfertide, a mimetic of the natural hormone
hepcidin, is the Company's lead drug candidate. VERIFY, the global Phase 3 registrational study of rusfertide in polycythemia vera,
is currently underway. Protagonist is headquartered in Newark, California. For more information on Protagonist, please visit the Company's
website at www.protagonist-inc.com.
Note on Forward-Looking Statements
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 plans to secure a collaborative partner to support further clinical development of PN-943, the clinical development of rusfertide
and our expectations regarding clinical trial enrollment, our expected cash runway and potential milestones related to PN-235. 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, 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.
Jami Taylor - j.taylor@ptgx-inc.com
Condensed Consolidated Statements of Operations
in thousands except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| License and collaboration revenue - related party | $ | 859 | $ | 2,265 | $ | 26,581 | $ | 8,454 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 34,611 | 26,432 | 70,929 | 50,677 | ||||||||||||
| General and administrative (1) | 7,691 | 6,715 | 18,206 | 12,680 | ||||||||||||
| Total operating expenses | 42,302 | 33,147 | 89,135 | 63,357 | ||||||||||||
| Loss from operations | (41,443 | ) | (30,882 | ) | (62,554 | ) | (54,903 | ) | ||||||||
| Interest income | 484 | 97 | 652 | 199 | ||||||||||||
| Other expense, net | (78 | ) | (57 | ) | (65 | ) | (136 | ) | ||||||||
| Net loss | $ | (41,037 | ) | $ | (30,842 | ) | $ | (61,967 | ) | $ | (54,840 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.84 | ) | $ | (0.69 | ) | $ | (1.27 | ) | $ | (1.23 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 49,049,902 | 44,964,637 | 48,902,047 | 44,546,172 |
Amount includes non-cash stock-based compensation expense
Stock-based Compensation
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Research and development | $ | 4,106 | $ | 2,155 | $ | 7,432 | $ | 3,630 | ||||||||
| General and administrative | 2,699 | 1,781 | 5,308 | 2,966 | ||||||||||||
| Total stock-based compensation expense | $ | 6,805 | $ | 3,936 | $ | 12,740 | $ | 6,596 |
Selected Consolidated Balance Sheet Data
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash, cash equivalents and marketable securities | $ | 291,890 | $ | 326,900 | ||||
| Working capital | 264,214 | 296,720 | ||||||
| Total assets | 310,512 | 347,695 | ||||||
| Deferred revenue - related party | - | 1,601 | ||||||
| Accumulated deficit | (471,329 | ) | (409,362 | ) | ||||
| Total stockholders' equity | 267,978 | 300,021 |