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
- While significant efforts have been undertaken toward the goal
of full enrollment of the Phase 3 VERIFY study, and a high degree
of interest has been observed from physician and patient
communities, operational challenges including site staff shortages
have continued to delay initial recruitment activities. The Company
expects enrollment completion in the second half of 2023.
- Protagonist will have three poster presentations at the 2022
ASH Annual Meeting & Exposition, taking place December 10-13 in New
Orleans, Louisiana. Details are as follows:
-
- Poster Presentation 1:
Title: VERIFY: A Phase 3 Study
of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with
Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Poster I
Session Date: Saturday, December 10,
2022
Presentation Time: 5:30 PM - 7:30 PM
CT.
- Poster Presentation 2:
Title: Subgroup Analysis of
Adverse Events Following Rusfertide Dosing in REVIVE: A Phase 2
Study of Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and
Epidemiological: Poster II
Session Date: Sunday, December 11,
2022
Presentation Time: 6:00 PM - 8:00 PM
CT.
- Poster Presentation 3:
Title: Rusfertide
Analog-PN23114 as a Hepcidin Mimetic Provides Efficacy Benefits in
Conjunction with Phlebotomy in Mouse Model for Hereditary
Hemochromatosis
Session Name: 102. Iron Homeostasis and Biology: Poster II
Session Date: Sunday, December 11,
2022
Presentation Time: 6:00 PM - 8:00 PM
CT.
- In keeping with the Company's organizational prioritization of
rusfertide in PV, plans to initiate studies of rusfertide in
additional disease indications have been paused. This decision was
influenced in part by enactment of the Inflation Reduction
Act in the U.S. and includes previously planned studies of
rusfertide in the subset of hereditary hemochromatosis (HH)
patients with chronic arthropathy.
PN-235: Oral IL-23 Receptor Antagonist
- Four clinical studies of PN-235 (JNJ-77242113), a drug
candidate discovered by Protagonist and further developed in
collaboration with Janssen, are underway and led by Janssen:
-
- FRONTIER 1, a Phase 2b
multicenter, randomized, placebo controlled, 240-patient
dose-ranging study commenced in early 2022 to evaluate the safety
and efficacy of PN-235 for the treatment of moderate-to-severe
plaque psoriasis;
- FRONTIER 2, a long-term extension study in moderate-to-severe
plaque psoriasis;
- SUMMIT, a study of an oral tablet formulation of PN-235 for the
treatment of moderate-to-severe plaque psoriasis; and
- A separate Phase 1 study of PN-235 in healthy Japanese and
Chinese participants. More information on these studies can be
found at https://www.clinicaltrials.gov/.
- Protagonist expects the results of these studies to inform the
next steps for PN-235 development. To date, $112.5 million in development milestones have
been received and the Company remains eligible for up to
approximately $855.0 million in
future development and sales milestones. In the near term, the
Company is eligible for a $10 million
milestone payment in connection with the start of a second
indication-based Phase 2 study, and a $50
million milestone upon dosing of a third patient in a Phase
3 study of PN-235.
PN-943: Oral, Gut-Restricted, alpha-4-beta-7 Integrin
Antagonist for Ulcerative Colitis (UC)
- With the exception of completing the 40-week extended treatment
period for eligible patients in the Phase 2 IDEAL study, expected
to be completed in Q1 2023, the Company intends to dedicate no
further internal resources to clinical development or CMC
activities for PN-943. The Company will continue to explore
out-licensing opportunities globally.
Management and Operational Updates
- Arturo Molina, M.D., M.S. has
joined Protagonist as its Chief Medical Officer (CMO). Dr. Molina's
responsibilities will include strategic and execution leadership
across the Company's clinical development programs, with a primary
focus on the Phase 3 VERIFY study of rusfertide in PV.
-
- Dr. Molina comes most recently from Sutro Biopharma, where he
was Chief Medical Officer for more than six years. Previously, from
2013 to 2016, Dr. Molina was Vice President, Oncology Scientific
Innovation, at Johnson & Johnson.
- De-prioritization of the PN-943 program and streamlining of
certain discovery programs is part of Company's ongoing commitment
to optimize and focus resources toward the rusfertide program in
PV.
Third Quarter 2022 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of September 30, 2022 were $267.4 million. The Company expects current cash,
cash equivalents and marketable securities to be sufficient to fund
its planned operating and capital expenditures through the end of
2024.
- License and Collaboration Revenue: License and
collaboration revenue was zero and $26.6
million for the three and nine months ended September 30, 2022, respectively, as compared to
$10.3 million and $18.7 million, respectively, for the same periods
in 2021. The decrease in revenue from prior year quarter was
primarily due to a decrease in the level of services the Company
provided under the Janssen license and collaboration agreement. The
Company completed its performance obligation pursuant to the
collaboration as of June 30, 2022.
The revenue increase from prior year-to-date included the
$25.0 million milestone that the
Company became eligible to receive in March
2022 upon the dosing of the third patient in the Janssen
Phase 2b FRONTIER 1 study of
PN-235.
- Research and Development ("R&D") Expenses: R&D
expenses were $25.4 million and
$96.3 million for the three and nine
months ended September 30, 2022 as
compared to $37.0 million and
$87.6 million for the same periods in
2021. The decrease in R&D expense from prior year quarter was
primarily due to lower PN-943 expenses related to the suspension of
further program expenditures and the impact of $4.0 million recorded during the third quarter of
2021 related to the resolution of the Company's collaboration
agreement dispute with Zealand Pharma. The increase in R&D
expense from prior year to date was primarily due to costs
associated with rusfertide and PN-943, including current and
planned Phase 3 clinical trials, partially offset by a decrease in
costs related to the completion of PN-235 and PN-232 Phase 1 trials
and the impact of $4.0 million
recorded during the third quarter of 2021 related to the resolution
of the Company's collaboration agreement dispute with Zealand
Pharma.
- General and Administrative ("G&A") Expenses: G&A
expenses were $6.9 million and
$25.1 million for the three and nine
months ended September 30, 2022 as
compared to $7.3 million and
$19.9 million for the same periods in
2021. The decrease from prior year quarter was primarily due to
decreases in consulting, legal and other expenses. The increase
from prior year to date was primarily due to increases in personnel
related and other expenses to support Company growth.
- Net Loss: Net loss was $31.2
million, or $0.64 per share,
for the three months ended September 30,
2022 as compared to a net loss of $33.8 million, or $0.70 per share, for the three months ended
September 30, 2021. Net loss was
$93.2 million, or $1.90 per share, for the nine months ended
September 30, 2022 as compared to a
net loss of $88.6 million, or
$1.94 per share for the nine months
ended September 30, 2021.
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.
Stock-based Compensation (Unaudited)
(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)
Selected Consolidated Balance Sheet Data
(In thousands)
|
|
|
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.