Full Press Release Details
Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
results from the Phase 2b FRONTIER 1 study of JNJ-2113 (formerly PN-235) in moderate-to-severe psoriasis, paving a path forward for initiation
of a Phase 3 pivotal study
statistically significant results from the randomized withdrawal portion of the REVIVE study of rusfertide in polycythemia vera, achieving
its primary endpoint of proportion of responders on rusfertide versus placebo (p=0.0003)
Calif., March 15, 2023 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the
Company") today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate
positive FRONTIER 1 JNJ-2113 (PN-235) data recently reported represents a scientific breakthrough with the potential to transform the
treatment landscape for moderate-to-severe plaque psoriasis with oral targeted therapy. We look forward to in-depth presentations of
JNJ-2113 pre-clinical and Phase 1 and Phase 2 clinical studies at medical conferences beginning in the second quarter of 2023,"
said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "In addition, we are extremely pleased to have
announced this morning the positive results from the randomized withdrawal part of the REVIVE study of rusfertide in polycythemia vera
(PV). The study met its primary endpoint, with a statistically significant higher number of responders on rusfertide versus placebo (p=0.0003).
Improvements in symptoms were observed, and rusfertide was generally well tolerated in the overall study."
Dr. Patel continued,
"These positive results from the Phase 2 FRONTIER 1 and REVIVE studies, of JNJ-2113 and rusfertide, respectively, are testaments
to the promise of our proprietary platform as well as the expertise, experience and commitment of the Protagonist team. We are focused
on enrolling patients globally in the Phase 3 VERIFY study of rusfertide in PV, and we are diligently preparing for the pre-commercial
launch-related activities for rusfertide.
our discovery engine remains prolific. We are evaluating pre-clinical compounds with the potential to have impact in areas of high unmet
medical need, and we are specifically advancing efforts in the oral hepcidin mimetic program. With two assets in late-stage development,
Protagonist is now closer than ever to bringing transformative new therapies to patients. As an industry leader in the discovery and
development of peptide therapeutics, we hold a unique set of capabilities that position our Company for value creation over the long
2022 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
(formerly PN-235): Oral IL-23 Receptor Antagonist
2022 Financial Results:
Condensed Consolidated Statements of Operations
in thousands except share and per share data)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| License and collaboration revenue - related party | $ | - | $ | 8,617 | $ | 26,581 | $ | 27,357 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 29,884 | 38,373 | 126,215 | 126,006 | ||||||||||||
| General and administrative (1) | 6,632 | 7,260 | 31,739 | 27,196 | ||||||||||||
| Total operating expenses | 36,516 | 45,633 | 157,954 | 153,202 | ||||||||||||
| Loss from operations | (36,516 | ) | (37,016 | ) | (131,373 | ) | (125,845 | ) | ||||||||
| Interest income | 2,251 | 122 | 4,060 | 443 | ||||||||||||
| Other income (expense), net | 71 | (13 | ) | (80 | ) | (149 | ) | |||||||||
| Net loss | $ | (34,194 | ) | $ | (36,907 | ) | $ | (127,393 | ) | $ | (125,551 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.69 | ) | $ | (0.77 | ) | $ | (2.60 | ) | $ | (2.71 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 49,262,643 | 48,154,171 | 49,042,232 | 46,322,910 |
Stock-based Compensation
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Research and development | $ | 3,429 | $ | 2,755 | $ | 14,719 | $ | 8,996 | ||||||||
| General and administrative | 2,083 | 2,269 | 9,483 | 7,399 | ||||||||||||
| Total stock-based compensation expense | $ | 5,512 | $ | 5,024 | $ | 24,202 | $ | 16,395 |
Selected Consolidated Balance Sheet Data
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash, cash equivalents and marketable securities | $ | 237,355 | $ | 326,900 | ||||
| Working capital | 211,198 | 298,720 | ||||||
| Total assets | 247,928 | 347,695 | ||||||
| Deferred revenue-related party | - | 1,601 | ||||||
| Accumulated deficit | (536,755 | ) | (409,362 | ) | ||||
| Total stockholders' equity | 215,608 | 300,021 |
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 (formerly 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 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.
topline results from the FRONTIER 1 study of JNJ-2113 in moderate-to-severe plaque psoriasis became available in March 2023, with further
details to be shared at medical meetings starting in the second quarter of 2023. Advancement of JNJ-2113 into a Phase 3 study and meeting
the primary endpoint in that study would qualify Protagonist for milestone payments of $50 million and $115 million, respectively. In
total, Protagonist remains eligible for up to $855 million in various milestone payments and tiered royalties based on worldwide net
information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 expectations regarding the potential benefits of JNJ-2113 and rusfertide, timing of JNJ-2113 clinical trials and potential milestones
related to JNJ-2113, 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,
impact of natural disasters and 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.
Taylor - j.taylor@ptgx-inc.com