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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d)
of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2023
PROTAGONIST THERAPEUTICS, INC.
(Exact name of registrant as specified
in its charter)
Delaware |
|
001-37852 |
|
98-0505495 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Protagonist Therapeutics, Inc.
7707 Gateway Blvd., Suite 140
Newark, California 94560-1160
(Address of principal executive offices,
including zip code)
(510) 474-0170
(Registrant’s telephone number, including
area code)
Not Applicable
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock, par value $0.00001 |
|
PTGX |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations
and Financial Condition.
On November 2, 2023, Protagonist
Therapeutics, Inc. reported its financial results for the third quarter ended September 30, 2023. A copy of the press release
titled “Protagonist Reports Third Quarter 2023 Financial Results and Provides Corporate Update” is furnished pursuant to Item
2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
The information in this report, including the exhibit hereto, shall
not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein
and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission
made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Protagonist Therapeutics, Inc. |
Dated: November 2, 2023 |
|
|
By: |
/s/ Asif Ali |
|
|
Asif Ali |
|
|
Chief Financial Officer |
Exhibit
99.1
Protagonist
Reports Third Quarter 2023 Financial Results and Provides Corporate Update
Five
rusfertide abstracts accepted for oral and poster presentations at the 65th ASH Annual Meeting and Exposition (ASH2023)
Positive
topline results from the Phase 2b FRONTIER 1 study of JNJ-2113 (formerly PN-235), the first- and only-in-class oral IL-23 receptor antagonist
peptide drug candidate for moderate-to-severe plaque psoriasis presented in July 2023
JNJ-2113
clinical development program advances with two Phase 3 studies in moderate-to-severe psoriasis and a Phase 2b study in moderately-to-severely
active ulcerative colitis (UC) commencing in Q4 2023; additional Phase 3 studies in psoriasis expected to begin in Q1 2024
Forecast
cash runway through Q1 20261
NEWARK,
Calif., November 2, 2023 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the
Company”) today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
“In the third
quarter of 2023, Protagonist continued to make rapid progress with its key programs,” said Dinesh V. Patel, Ph.D., the Company’s
President and CEO. “Positive Phase 2b data from the FRONTIER 1 study with JNJ-2113, established it as a first- and only-in-class
oral IL-23 receptor antagonist peptide and triggered the decision to progress into several advanced studies for broad clinical development.
In October 2023, Janssen initiated two Phase 3 psoriasis studies, and a Phase 2b ulcerative colitis study, and plans to undertake additional
Phase 3 psoriasis studies in the first quarter of next year. The extraordinary pace of progress in multiple indications reflects strong
confidence in JNJ-2113’s potential to have a meaningful impact on these and other diseases mediated by the IL-23 pathway.”
Dr. Patel continued:
“We are equally excited about the potential of rusfertide, currently in the Phase 3 VERIFY study, to transform the treatment paradigm
for polycythemia vera. We are very pleased with the continuing level of enthusiasm among PV-treating physicians and patients participating
in the ongoing Phase 3 VERIFY study and look forward to sharing our latest findings in Polycythemia Vera and from our ongoing studies
through five oral and poster presentations at the upcoming ASH2023 Annual Meeting.”
1
Based on $322.7 million in cash, cash equivalents and marketable securities as of September
30, 2023 and including expected $60.0 million in JNJ-2113 milestones.
Q3 and Recent
Corporate Highlights
| · | Positive
Phase 2b FRONTIER 1 topline results were presented at the World Congress of Dermatology in
Singapore in July 2023. All primary and secondary efficacy endpoints were achieved in the
study, which evaluated five different dosing regimens of JNJ-2113 in adult patients with
moderate-to-severe plaque psoriasis. JNJ-2113 is a novel oral IL-23R antagonist peptide which
binds with high affinity to the IL-23 receptor. |
| · | Following
positive data from the FRONTIER 1 study, advanced clinical studies in multiple indications
were announced and recently initiated: |
| § | ICONIC-LEAD
is a randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113
compared with placebo in participants with moderate-to-severe plaque psoriasis, with PASI-90
and IGA score of 0 or 1 as co-primary endpoints. |
| § | ICONIC-TOTAL
is a randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113
compared with placebo for the treatment of plaque psoriasis in participants with at least
moderate severity affecting special areas (scalp, genital, and/or palms of the hands and
the soles of the feet) with overall IGA score of 0 or 1 as the primary end point. |
| § | ANTHEM-UC
is a Phase 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113
compared with placebo in patients with moderately to severely active ulcerative colitis. |
| · | Dosing
of the third patient in the ICONIC-LEAD Phase 3 trial in late October 2023 earned Protagonist
a $50 million milestone from Janssen Biotech, Inc. under the terms of the licensing and collaboration
agreement between both companies. |
| · | Five
abstracts related to rusfertide, an investigational hepcidin mimetic, were accepted for oral
or poster presentation at ASH2023, as follows: |
Oral
presentations
| § | Title:
Real-World Analysis of Thromboembolic Event Rates in Patients in the United States with Polycythemia
Vera. Presenting author: Andrew T. Kuykendall, MD (Moffitt Cancer Center, Tampa, FL). |
| § | Title:
Durability of Hematocrit Control in Polycythemia Vera with the First-in-Class Hepcidin Mimetic
Rusfertide: Two-Year Follow up Results from the Revive Study. Presenting author: Ellen K.
Ritchie, MD (Weill Cornell Medical College New York Presbyterian, NY). |
Poster presentations
| § | Title:
Iron Restricted Erythropoiesis Under Hepcidin Mimetic Treatment (PN23114) Improved Disease
Parameters in a Mouse Model for Sickle Cell Disease. Presenting author: Roopa Taranath, PhD
(Protagonist Therapeutics, Inc., Newark, CA). |
| § | Title:
Rusfertide Improves Markers of Iron Deficiency in Patients with Polycythemia Vera. Presenting
author: Yelena Ginzburg, MD (Mount Sinai, New York, NY). |
| § | Title:
Prevalence of Second Cancers in Patients with Polycythemia Vera (PV): A Retrospective Analysis
of US Real-World Claims Data. Presenting author: Naveen Pemmaraju, MD (MD Anderson Cancer
Center, Houston, TX). |
At the 5th International
Congress on Myeloproliferative Neoplasms, held November 2-3, 2023, Dr. Naveen Pemmaraju presented a poster titled, “Summary of
Malignancies Observed Across 5 Open Label Clinical Trials of the Hepcidin Mimetic Rusfertide.” The poster can be found on the Protagonist
corporate website at https://www.protagonist-inc.com/publications.
Third Quarter 2023 Financial Results
| · | Cash,
Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities
as of September 30, 2023, were $322.7 million. |
| · | License
and Collaboration Revenue: License and collaboration revenue was zero for the three and
nine months ended September 30, 2023, as we completed our performance obligation associated
with the Janssen License and Collaboration Agreement as of June 30, 2022. License and collaboration
revenue for the three and nine months ended September 30, 2022, was zero and $26.6 million,
respectively. The nine months ended September 30, 2022, included a one-time $25.0 million
milestone earned by the Company following the dosing of the third patient in the Janssen
Phase 2b FRONTIER 1 clinical trial of JNJ-2113. |
| · | Research
and Development ("R&D") Expenses: R&D expenses were $30.7 million and
$91.3 million for the three and nine months ended September 30, 2023, respectively, as compared
to $25.4 million and $96.3 million for the same periods in 2022. The increase in R&D
expenses from the prior year quarter was primarily due to an increase in rusfertide expenses
related to the Phase 3 VERIFY clinical trial, partially offset by a decrease in PN-943 expenses.
The decrease in R&D expenses from the prior year was primarily due to decreases in PN-943
expenses and costs related to preclinical and discovery research, partially offset by an
increase in rusfertide expenses. |
| · | General
and Administrative ("G&A") Expenses: G&A expenses were $7.7 million
and $25.4 million for the three and nine months ended September 30, 2023, respectively, as
compared to $6.9 million and $25.1 million for the same periods in 2022. The increase in
G&A expenses from the prior year quarter was primarily due to increases in payroll, stock-based
compensation, and general expenses. |
| · | Net
Loss: Net loss was $34.1 million, or $0.58 per share, for the three months ended September
30, 2023, as compared to a net loss of $31.2 million, or $0.64 per share, for the three months
ended September 30, 2022. Net loss was $106.3 million, or $1.91 per share, for the nine months
ended September 30, 2023, as compared to a net loss of $93.2 million, or $1.90 per share,
for the nine months ended September 30, 2022. |
About
Protagonist
Protagonist
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235)
in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen
scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration
with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further
clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global
Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and 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.
More
information on Protagonist, its pipeline drug candidates and clinical studies can be found on 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 the potential benefits of rusfertide and JNJ-2113, our expectations
regarding the clinical development of JNJ-2113 and our potential receipt of milestone and royalty payments under our collaboration agreement
with Janssen. 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 agreement with Janssen, 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.
Contact
Corey
Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com
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, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
License and collaboration revenue | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | 26,581 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development (1) | |
| 30,664 | | |
| 25,402 | | |
| 91,262 | | |
| 96,331 | |
General and administrative (1) | |
| 7,662 | | |
| 6,901 | | |
| 25,439 | | |
| 25,107 | |
Total operating expenses | |
| 38,326 | | |
| 32,303 | | |
| 116,701 | | |
| 121,438 | |
Loss from operations | |
| (38,326 | ) | |
| (32,303 | ) | |
| (116,701 | ) | |
| (94,857 | ) |
Interest income | |
| 4,252 | | |
| 1,157 | | |
| 10,656 | | |
| 1,809 | |
Other expense, net | |
| (31 | ) | |
| (86 | ) | |
| (245 | ) | |
| (151 | ) |
Net loss | |
$ | (34,105 | ) | |
$ | (31,232 | ) | |
$ | (106,290 | ) | |
$ | (93,199 | ) |
Net loss per share, basic and diluted | |
$ | (0.58 | ) | |
$ | (0.64 | ) | |
$ | (1.91 | ) | |
$ | (1.90 | ) |
Weighted-average shares used to compute net loss per share, basic and diluted | |
| 59,182,899 | | |
| 49,107,639 | | |
| 55,542,543 | | |
| 48,971,329 | |
(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, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 3,780 | | |
$ | 3,858 | | |
$ | 13,171 | | |
$ | 11,290 | |
General and administrative | |
| 2,985 | | |
| 2,092 | | |
| 9,521 | | |
| 7,400 | |
Total stock-based compensation expense | |
$ | 6,765 | | |
$ | 5,950 | | |
$ | 22,692 | | |
$ | 18,690 | |
PROTAGONIST
THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(Unaudited)
(In
thousands)
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Cash, cash equivalents and marketable securities | |
$ | 322,736 | | |
$ | 237,355 | |
Working capital | |
| 297,014 | | |
| 211,898 | |
Total assets | |
| 330,016 | | |
| 247,928 | |
Accumulated deficit | |
| (643,045 | ) | |
| (536,755 | ) |
Total stockholders' equity | |
| 302,149 | | |
| 215,608 | |
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Protagonist Therapeutics (NASDAQ:PTGX)
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From May 2024 to Jun 2024
Protagonist Therapeutics (NASDAQ:PTGX)
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From Jun 2023 to Jun 2024