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Protagonist Reports First Quarter 2022 Financial Results and Provides Corporate Update Initiated Phase 3 VERIFY study of rusfertide in polycythemia vera, reaffirming rusfertide in PV as the Company's primary point of foc

Key Takeaway: Reports First Quarter 2022 Financial Results and Provides Corporate Update Phase 3 VERIFY study of rusfertide in polycythemia vera, reaffirming rusfertide in PV as the Company's primary point of focus topline results from the Phase 2 IDEAL study of PN-943 in ulcerative colitis

Full Press Release Details

Reports First Quarter 2022 Financial Results and Provides Corporate Update
Phase 3 VERIFY study of rusfertide in polycythemia vera, reaffirming rusfertide in PV as the Company's primary point of focus
topline results from the Phase 2 IDEAL study of PN-943 in ulcerative colitis with consistent treatment effects at the lower 150 mg BID
dose across key endpoints; formally engaged PJT Partners to lead external partnering efforts
payment of $25 million received from Janssen upon dosing of third patient in the Phase 2B FRONTIER-1 study of PN-235 in psoriasis
Calif., May 4, 2022 - Protagonist Therapeutics (Nasdaq:
PTGX) ("Protagonist" or "the Company") today reported financial results for the first quarter of 2022 ended March 31,
2022 and provided a corporate update.
has been a period of important clinical results and strategic focus," said Dinesh V. Patel, Ph.D., President and Chief Executive
Officer of Protagonist. "Today, we reaffirm rusfertide as the primary focus of our organization's resources, time, and attention.
This prioritization is based on the compelling data we have obtained to date and the potential of this therapeutic peptide to transform
the treatment of patients with polycythemia vera. We are committed to the execution of all critical activities related to the successful
completion of the Phase 3 VERIFY study. We look forward to a productive ongoing dialogue with regulators, and sharing important data
from our ongoing rusfertide studies at upcoming medical meetings."
Dr. Patel continued:
"Recently, we released topline data from the Phase 2 IDEAL study of PN-943, our oral, gut-restricted alpha-4 beta-7-integrin antagonist
drug candidate in development for ulcerative colitis. We are pleased and encouraged with the positive results across different measures
in the lower dose arm, and are scheduled for an oral presentation at the Digestive Disease Week (DDW) conference later this month. Based
on the consistency of our results with previous studies with other agents that target the integrin-MadCAM pathway, and the strong concordance
across different measures in the lower dose arm of this Phase 2 study, we believe that PN-943 may represent a substantial commercial
opportunity and merits further clinical development. We intend to pursue further clinical development in collaboration with a large pharma
partner or through a structured financing arrangement. We have now formally engaged PJT Partners to facilitate a collaboration arrangement
with a pharmaceutical company. In addition to commercialization capabilities, we believe that a partner can add the financial and development
resources required to maximize the potential benefit to patients that could be provided by this important therapeutic candidate. At the
current time, our planned expenses for PN-943 are related to finalizing the Phase 3 study design with regulators and completing the ongoing
manufacturing of clinical trial materials to support study initiation. We expect these activities to have a minimal impact on our cash
resources and we retain our prior guidance of cash runway through the end of 2024."
Quarter 2022 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
Oral, gut-restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)
Oral IL-23 Receptor Antagonist
Quarter 2022 Financial Results
Protagonist Therapeutics
is a biopharmaceutical company with multiple peptide-based new chemical entities in different stages of clinical development, all derived
from the Company's proprietary technology platform.
Protagonist's pipeline
includes rusfertide, an investigational, injectable hepcidin mimetic currently in the REVIVE Phase 2 proof-of-concept clinical trial
for polycythemia vera (PV), the PACIFIC Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study
for hereditary hemochromatosis. The Company has opened sites and initiated patient screening for VERIFY, a single, global Phase 3 randomized,
placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide for
patients living with PV.
The IDEAL Phase 2 study
of PN-943 in moderate-to-severe ulcerative colitis concluded in April 2022. The results of this Phase 2 study supported advancement
of the 150-milligram dose of PN-943 into a Phase 3 study. Efforts to secure a partner to support the financing and execution of a Phase
3 study are underway.
Protagonist has granted
Janssen an exclusive worldwide license to research, develop and commercialize oral IL-23 receptor antagonists based on the Company's
intellectual property. Current development efforts are centered on PN-235, discovered by Protagonist and further developed in collaboration
with Janssen. FRONTIER 1, a Phase 2b multicenter, randomized, placebo controlled, dose-ranging study to evaluate the safety and efficacy
of PN-235 for the treatment of moderate-to-severe plaque psoriasis, commenced in early 2022.
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 potential commercial opportunity of
PN-943, the clinical development of rusfertide 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
Media: Joshua R. Mansbach
Condensed Consolidated Statements of Operations
in thousands except share and per share data)
Three Months Ended
March 31,
2022 2021
License and collaboration revenue - related party $ 25,722 $ 6,189
Operating expenses:
Research and development (1) 36,318 24,245
General and administrative (1) 10,515 5,965
Total operating expenses 46,833 30,210
Loss from operations (21,111 ) (24,021 )
Interest income 168 102
Other income (expense), net 13 (79 )
Net loss $ (20,930 ) $ (23,998 )
Net loss per share, basic and diluted $ (0.43 ) $ (0.54 )
Weighted-average shares used to compute net loss per share, basic and diluted 48,752,548 44,224,169
Stock-Based Compensation
Three Months Ended
March 31,
2022 2021
Research and development $ 3,326 $ 1,475
General and administrative 2,609 1,185
Total stock-based compensation expense $ 5,935 $ 2,660
Selected Condensed Consolidated Balance Sheet Data
March 31, December
2022 2021
Cash, cash equivalents and marketable securities $ 305,289 $ 326,900
Working capital 298,066 296,720
Total assets 348,296 347,695
Deferred revenue-related party 768 1,601
Accumulated deficit (430,292 ) (409,362 )
Total stockholders' equity 301,778 300,021
Last updated: May 4, 2022