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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): August 6, 2024
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 August 6, 2024, Protagonist
Therapeutics, Inc. reported its financial results for the second quarter ended June 30, 2024. A copy of the press release titled
“Protagonist Reports Second Quarter 2024 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: August 6, 2024 |
|
| |
By: |
/s/
Asif Ali |
| |
Asif Ali |
| |
|
Chief Financial Officer |
Exhibit 99.1
Protagonist Reports
Second Quarter 2024 Financial Results and Provides Corporate Update
JNJ-2113 Phase
3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in moderate-to-severe plaque psoriasis expected to complete the primary endpoint
portion of the studies in Q4 2024
JNJ-2113 Phase
2b ANTHEM clinical trial in moderate-to-severe ulcerative colitis expected to complete the primary endpoint portion of the study in Q4
2024
Rusfertide Phase
2 REVIVE study long-term follow-up data in polycythemia vera presented at European Hematology Association
(EHA) 2024; study showed durable hematocrit control, decreased phlebotomy use, long-term tolerability and no new safety signals
Rusfertide topline
results from the 32-week primary endpoint of the Phase 3 VERIFY study expected in Q1 2025
Cash, cash equivalents
and marketable securities of $595.4M as of June 30, 2024, anticipated to provide cash runway through end of 2027
NEWARK,
Calif., August 6, 2024 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the
Company”) today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.
“During the second quarter of
2024 our team made tremendous strides in the late-stage clinical development of rusfertide and also in leveraging our proprietary discovery
platform for early-stage, but highly differentiated, oral peptides-based discovery programs,” said Dinesh V. Patel, Ph.D., the
Company’s President and CEO. “We presented updated long-term data from the REVIVE Phase 2 trial at EHA that reaffirms rusfertide’s
durability of positive response in polycythemia vera, and we look forward to the Phase 3 VERIFY 32-week primary endpoint readout in Q1
2025. We are excited at the prospect of introducing multiple new development candidates in a variety of indications over the next 12
months where oral peptides would offer a strong differentiation versus existing options. Additionally, our addition to the S&P SmallCap
600® index highlights the value Protagonist brings to shareholders and provides additional visibility within the investment
community.”
Dr. Patel continued, “We
are also very pleased with the rapid pace of enrollment in the five different ongoing Phase 3 trials of JNJ-2113 in psoriasis and the
Phase 2b study in ulcerative colitis. With the primary endpoint portion of the
ICONIC-LEAD in moderate-to-severe plaque psoriasis, ICONIC-TOTAL in psoriasis in special body regions, and ANTHEM in ulcerative
colitis studies all expected to be completed this year, we look forward to uncovering the potential and differentiation of JNJ-2113,
the first and only targeted oral IL-23 receptor antagonist (IL23Ri) peptide.”
Second
Quarter 2024 Recent Developments and Upcoming Milestones
| · | Dr. Newman
Yeilding joined the Protagonist executive team as Chief Scientific Advisor, effective August 1st.
His 20-plus years of work experience, including seven years as the Head of Immunology at
Janssen Pharmaceutical Companies of Johnson & Johnson, covered
a broad range of research and development (R&D) responsibilities in the inflammation
and immunomodulatory (I&I) diseases space including Rheumatology, Gastroenterology, Dermatology
and Pediatric Development. Dr. Yeilding’s insights in the field and guidance on
the expansion of the Company’s discovery platform and R&D pipeline will be of significant
value. |
Rusfertide:
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)
| · | Updated
long-term (up to 3-year) follow-up data from the REVIVE Phase 2 study in PV was presented
at the EHA 2024 Congress. The presentation showed
durability of response as measured by hematocrit (Hct) control (< 45%), decreased phlebotomy
use, long-term tolerability, and no new safety signals. |
| · | The
Company expects to announce top-line data for the VERIFY
study’s 32-week primary efficacy endpoint in
PV in Q1 of 2025. |
JNJ-2113:
Oral IL-23 Receptor Antagonist for Psoriasis (PsO) and Ulcerative Colitis (UC)
| · | On
July 30, 2024, data summarizing preclinical findings and its translational correlation
with phase 1 clinical data on JNJ-2113 were published in the journal Scientific Reports,
a Nature publication and the fifth most-cited journal in the world. |
| · | The
16-week primary endpoint portion of the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies in PsO1,
which began in Q4 of 2023, are expected to be completed in Q4 2024. |
| · | The
12-week primary endpoint portion of the Phase
2b ANTHEM multicenter, randomized, placebo-controlled, dose-ranging study of JNJ-2113 for
the treatment of moderately-to-severely active UC2 is
expected to be completed in Q4 2024. |
| · | The
16-week primary endpoint portion of the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority
studies in PsO3, evaluating the safety and efficacy of JNJ-2113 compared with
both placebo and deucravacitinib is expected to be completed in Q1 2025. |
| · | The
primary endpoint portion of the Phase 3 in pustular and erythrodermic psoriasis4
evaluating the safety and efficacy of JNJ-2113 in approximately 16 subjects compared with
placebo is expected to be completed in Q1 2025. |
Discovery
Programs
| · | Protagonist
is pursuing the discovery of novel oral peptides against various clinically validated biological
targets in hematology, I&I diseases, and obesity and related indications. |
| · | The
Company announced an oral IL-17 discovery program in January 2024 with a development
candidate expected to be announced by end of 2024. |
| · | Protagonist
is also anticipating the nomination of a development candidate in the hematology space and
an oral peptide-based development candidate in the obesity program by the middle of 2025. |
1
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
2
ANTHEM (NCT06049017)
3
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
4
Pustular/Erythrodermic (NCT06295692)
Second Quarter 2024 Financial Results
| · | Cash,
Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities
as of June 30, 2024, were $595.4 million as compared to $341.6 million as of December 31,
2023. The increase reflects the receipt in April 2024 of the upfront payment from the
Takeda Worldwide License and Collaboration Agreement
for rusfertide (the “Collaboration Agreement”) entered in Q1 2024. |
| | |
Three Months Ended | | |
Six Months Ended | |
| | |
June 30, | | |
June 30, | |
| (in thousands, except per share amounts) | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| License and collaboration revenue | |
$ | 4,167 | | |
$ | - | | |
$ | 259,120 | | |
$ | - | |
| Research and development expense | |
$ | 33,520 | | |
$ | 33,182 | | |
$ | 67,254 | | |
$ | 60,598 | |
| General and administrative expense | |
$ | 9,440 | | |
$ | 9,172 | | |
$ | 24,350 | | |
$ | 17,777 | |
| Net income (loss) | |
$ | (30,616 | ) | |
$ | (38,460 | ) | |
$ | 176,724 | | |
$ | (72,185 | ) |
| Basic earnings (loss) per share | |
$ | (0.50 | ) | |
$ | (0.68 | ) | |
$ | 2.89 | | |
$ | (1.34 | ) |
| Diluted earnings (loss) per share | |
$ | (0.50 | ) | |
$ | (0.68 | ) | |
$ | 2.77 | | |
$ | (1.34 | ) |
| · | License
and Collaboration Revenue: The Collaboration Agreement included a nonrefundable
upfront payment of $300.0 million of which we recognized $255.0 million during the
first quarter of 2024. The remaining $45.0 million was recorded as deferred revenue
to be recognized over time as the Company satisfies its performance obligation to complete
the ongoing Phase 3 VERIFY trial for rusfertide. |
During the second quarter
of 2024, we recognized $4.2 million of this deferred revenue balance as revenue based on costs incurred in the quarter compared to the
total budget for this performance obligation. License and collaboration revenue of $259.1 million for the six months ended June 30,
2024, is comprised of: (i) $255.0 million of the $300.0 million upfront cash payment for the Takeda Collaboration Agreement recorded
in the first quarter of 2024 and (ii) the $4.2 million recorded as revenue during the second quarter of 2024.
| · | Research
and Development ("R&D") Expenses: The increase of $6.7 million in R&D
expenses for the six months ended June 30, 2024 from the prior year period was primarily
due to increases in drug discovery and pre-clinical research expenses. |
| · | General
and Administrative ("G&A") Expenses: The increase in G&A expenses for
the six months ended June 30, 2024 of $6.6 million from the prior year period was primarily
due to $4.6 million in one-time advisory and legal fees related to the Takeda collaboration
and an increase of approximately $2.0 million in stock-based compensation and other personnel-related
expenses. |
| · | Net
Income (Loss): Net loss was ($30.6) million, or ($0.50) per basic and diluted share,
for the three months ended June 30, 3024, as compared to a net loss of ($38.5) million,
or ($0.68) per basic and diluted share, for the three months ended June 30, 2023. Net
income was $176.7 million, or $2.89 per basic share and $2.77 per diluted share, for the
six months ended June 30, 2024, as compared to a net loss of ($72.2) million, or ($1.34)
per basic and diluted share, for the six months ended June 30, 2023. |
About Protagonist
Protagonist
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235)
in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and
Johnson & Johnson (JNJ) scientists jointly discovered JNJ-2113 as part of Protagonist's Interleukin-23 receptor (IL-23R) antagonist
collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further
clinical development. JNJ-2113 is currently being pursued in five Phase 3 studies in psoriasis, and a Phase 2b study in ulcerative colitis.
Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development
program for polycythemia vera (PV). The randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were
published in The New England Journal of Medicine in February 2024. The open-label extension (OLE) component of REVIVE has
also been completed and is followed by an additional 2-year long-term extension (LTE) THRIVE study. Enrollment has been completed in
the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda
pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024.
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 JNJ-2113 and rusfertide, the timing of
JNJ-2113 and rusfertide clinical trials, and timing of developments in our discovery programs. 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 with Janssen and Takeda, 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.
Investor
Relations Contact
Corey
Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061
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, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| License and collaboration revenue | |
$ | 4,167 | | |
$ | - | | |
$ | 259,120 | | |
$ | - | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development (1) | |
| 33,520 | | |
| 33,182 | | |
| 67,254 | | |
| 60,598 | |
| General and administrative (1) | |
| 9,440 | | |
| 9,172 | | |
| 24,350 | | |
| 17,777 | |
| Total operating expenses | |
| 42,960 | | |
| 42,354 | | |
| 91,604 | | |
| 78,375 | |
| Income (loss) from operations | |
| (38,793 | ) | |
| (42,354 | ) | |
| 167,516 | | |
| (78,375 | ) |
| Interest income | |
| 7,404 | | |
| 3,913 | | |
| 11,780 | | |
| 6,404 | |
| Other income (expense), net | |
| 97 | | |
| (19 | ) | |
| 78 | | |
| (214 | ) |
| Income (loss) before income tax benefit (expense) | |
| (31,292 | ) | |
| (38,460 | ) | |
| 179,374 | | |
| (72,185 | ) |
| Income tax benefit (expense) | |
| 676 | | |
| - | | |
| (2,650 | ) | |
| - | |
| Net income (loss) | |
$ | (30,616 | ) | |
$ | (38,460 | ) | |
$ | 176,724 | | |
$ | (72,185 | ) |
| Net income (loss) per share, basic | |
$ | (0.50 | ) | |
$ | (0.68 | ) | |
$ | 2.89 | | |
$ | (1.34 | ) |
| Net income (loss) per share, diluted | |
$ | (0.50 | ) | |
$ | (0.68 | ) | |
$ | 2.77 | | |
$ | (1.34 | ) |
| Weighted-average shares used to compute net income (loss) per share, basic | |
| 61,305,289 | | |
| 56,775,742 | | |
| 61,080,489 | | |
| 53,691,965 | |
| Weighted-average shares used to compute net income (loss) per share, diluted | |
| 61,305,289 | | |
| 56,775,742 | | |
| 63,909,633 | | |
| 53,691,965 | |
(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, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Research and development | |
$ | 5,097 | | |
$ | 4,809 | | |
$ | 10,385 | | |
$ | 9,391 | |
| General and administrative | |
| 3,847 | | |
| 3,534 | | |
| 7,911 | | |
| 6,536 | |
| Total stock-based compensation expense | |
$ | 8,944 | | |
$ | 8,343 | | |
$ | 18,296 | | |
$ | 15,927 | |
PROTAGONIST THERAPEUTICS,
INC.
Selected Consolidated Balance Sheet Data
(In thousands)
| | |
June 30, | | |
December 31, | |
| | |
2024 | | |
2023 | |
| Cash, cash equivalents and marketable securities | |
$ | 595,444 | | |
$ | 341,617 | |
| Receivable from collaboration partner | |
| 43 | | |
| 10,000 | |
| Working capital | |
| 529,347 | | |
| 334,303 | |
| Total assets | |
| 614,629 | | |
| 357,951 | |
| Accumulated deficit | |
| (438,986 | ) | |
| (615,710 | ) |
| Total stockholders' equity | |
| 541,324 | | |
| 336,677 | |
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