Continued focus on Phase 3 VERIFY study of
rusfertide in polycythemia vera (PV)
Presented new, positive data from Phase 2
REVIVE study of rusfertide in PV at the 2022 ASCO Annual Meeting
and the EHA2022 Congress
Strong cash position, with cash runway through
end of 2024
NEWARK,
Calif., Aug. 4, 2022 /PRNewswire/
-- 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.
"We 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 PV."
Dr. Patel 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."
Second Quarter 2022 Recent Developments
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for
Polycythemia Vera (PV) and Other Blood Disorders
- It is the Company's objective to complete the planned
250-patient enrollment in the Phase 3 VERIFY study by the end of
the first half of 2023. Notwithstanding a slower than anticipated
pace of initial enrollment, 35 study sites have been activated
globally to date. The Company continues to implement measures to
increase patient recruitment, screening, and enrollment.
- 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.
- Updated data from the Phase 2 REVIVE study were shared as a
poster presentation at the European Hematology Association 2022
Congress (EHA2022), given by Dr. Andrew
Kuykendall, M.D., Assistant Member at the Moffitt Cancer
Center in the Department of Malignant Hematology.
- Data from the Phase 2 REVIVE study data were presented at the
European Iron Club Conference by Dr. Yelena
Ginzburg, M.D., Associate Professor of Hematology and
Medical Oncology at the Icahn School of Medicine at Mount
Sinai.
- Chronic arthropathy occurs in a significant subset of patients
with hereditary hemochromatosis (HH). HH arthropathy correlates
with iron overload and is associated with transferrin saturation
(TSAT), ferritin, elevated age, and unresponsiveness to phlebotomy
treatment. Protagonist intends to design a Phase 2 study of
rusfertide in this HH sub-population, in consultation with
regulatory agencies.
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 in different stages of clinical
development at Janssen. These include
-
- 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;
- 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 is eligible for a $10
million milestone payment in connection with the start of a
second indication-based Phase 2 study. The Company is also eligible
for 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)
- The Company submitted a request to FDA for a clinical protocol
guidance meeting and is awaiting written responses from FDA related
to the Phase 3 study plan. The Phase 3 study plan is anchored
around the 150 mg BID dose of PN-943, pending regulatory
guidance.
- Protagonist intends to pursue further clinical development of
PN-943 in collaboration with a large pharmaceutical partner. As
announced previously, the Company has engaged PJT Partners to
identify and evaluate such partnering opportunities.
- The results of the IDEAL study have been selected for an oral
presentation at the United European Gastroenterology Week (UEGW) in
October 2022.
-
- Presentation Title: "A Phase 2 Randomized, Double-Blind,
Placebo-Controlled, Multi-Center Study to Evaluate the Safety and
Efficacy of the Oral, Gut-Restricted α4β7 Integrin Peptide
Antagonist PN-943 in Patients with Moderate to Severe Ulcerative
Colitis: Results from the IDEAL Study."
- Presentation Date and Time: October 10,
2022; 9:30 AM to 10:30 AM
PT
- Abstract Number: AS-UEG-2022-03120.
Second Quarter 2022 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash,
cash equivalents and marketable securities as of June 30, 2022 were $291.9
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 $0.9
million and $26.6 million for
the three and six months ended June 30,
2022, respectively, as compared to $2.3 million and $8.5
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
a performance obligation pursuant to the collaboration as of
June 30, 2022. The revenue increase
from prior year-to-date was primarily due to 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 $34.6 million and
$70.9 million for the three and six
months ended June 30, 2022 as
compared to $26.4 million and
$50.7 million for the same periods in
2021. The increases were primarily due to costs associated with
advancing rusfertide and PN-943, including current and planned
Phase 3 clinical trials.
- General and Administrative ("G&A") Expenses: G&A
expenses were $7.7 million and
$18.2 million for the three and six
months ended June 30, 2022 as
compared to $6.7 million and
$12.7 million for the same periods in
2021. The increases were primarily due to personnel expenses and
other expenses to support Company growth.
- Net Loss: Net loss was $41.0
million, or $0.84 per share,
for the three months ended June 30,
2022 as compared to a net loss of $30.8 million, or $0.69 per share, for the three months ended
June 30, 2021. Net loss was
$62.0 million, or $1.27 per share, for the six months ended
June 30, 2022 as compared to a net
loss of $54.8 million, or
$1.23 per share for the six months
ended June 30, 2021.
About Protagonist
Protagonist 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.
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 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.
PROTAGONIST
THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amount
includes non-cash stock-based compensation expense
|
PROTAGONIST
THERAPEUTICS, INC.
Stock-based Compensation
(In
thousands)
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROTAGONIST
THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
|
|
|
June
30,
|
|
December
31,
|
2022
|
2021
|
Cash, cash equivalents
and marketable securities
|
$
|
291,890
|
|
$
|
326,900
|
Working
capital
|
|
264,214
|
|
|
269,720
|
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
|
|
|
|
|
|
|
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SOURCE Protagonist Therapeutics, Inc.