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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): February 21, 2025
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 February 21, 2025, Protagonist Therapeutics,
Inc. reported its financial results for the fourth quarter and full year ended December 31, 2024. A copy of the press release titled “Protagonist
Reports Fourth Quarter and Full Year 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: February 21, 2025 |
|
| |
By: |
/s/ Asif Ali |
| |
Asif Ali |
| |
|
Chief Financial Officer |
Exhibit
99.1
Protagonist
Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
$165.0
million icotrokinra (formerly JNJ-2113) milestone earned in Q4 2024, received in January 2025
PN-881,
a potential best-in-class oral IL-17 receptor antagonist peptide nominated as a development candidate in Q4 2024
Topline results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in March 2025
Topline results for icotrokinra Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in March 2025
Cash,
cash equivalents, and marketable securities of $559.2 million as of December 31, 2024, combined with $165.0 million milestone payment,
anticipated to provide cash runway through at least end of 2028
NEWARK,
Calif., February 21, 2025 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the
Company”) today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate
update.
“Protagonist
is quickly approaching multiple late-stage transformational events expected in the first quarter of this year, including the topline
results from the VERIFY Phase 3 study of rusfertide in polycythemia vera and from the ANTHEM Phase 2b ulcerative colitis study of icotrokinra”,
said Dinesh V. Patel, Ph.D., the Company’s President and CEO. “In addition, we look forward to progressing oral IL-17 peptide
antagonist PN-881 in clinical studies and nominating new development candidates from the oral obesity and oral hepcidin programs
this year. We are fortunate to be in a strong cash position, enabling the flexibility to progress these early-stage peptide drug candidates
independently into pre-clinical and clinical proof-of-concept studies over the coming years.”
2024
Key Highlights
Worldwide License and Collaboration
Agreement for Rusfertide with Takeda
| · | On
January 31, 2024, the Company and Takeda announced a worldwide license and collaboration
agreement for rusfertide (the “Takeda License and Collaboration Agreement”).
The Company received an upfront cash payment of $300.0 million in April 2024 and is eligible to receive
up to $330.0 million in development, regulatory, and sales milestones, for a potential deal
value of up to $630.0 million, as well as an equal share of profits and losses in the U.S.
and royalties on net sales outside the U.S. |
| · | Under the terms of the agreement, the Company has the right to opt-out of
the 50:50 profit share after NDA filing. In that event, the Company would be eligible to receive opt-out fees of up to $400 million and
enhanced milestones of up to $975 million, as well as royalties on worldwide net sales. Takeda would maintain full ex-U.S. rights
under either scenario. |
Two
articles published in the New England Journal of Medicine (“NEJM”) in February 2024
| · | On February 7, 2024, the icotrokinra
Phase 2b FRONTIER 1 trial results in adults living with moderate-to-severe plaque psoriasis were published in the NEJM. |
| · | On February 21, 2024, the complete
Phase 2 REVIVE trial results for rusfertide, including efficacy and safety, were published in the NEJM. |
S&P
SmallCap 600 Index
| · | The Company joined the Index on July
3, 2024. |
Icotrokinra: Oral IL-23 Receptor
Antagonist
| · | Positive
topline results for the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies1 in moderate to severe plaque psoriasis, were reported
in Q4 2024. |
| o | In the ICONIC-LEAD study, once-daily icotrokinra
showed significant skin clearance versus placebo in adults and adolescents with moderate
to severe plaque psoriasis. At week 16, nearly two-thirds (64.7%) of patients treated with
icotrokinra achieved IGA3 scores of 0/1 (clear or almost clear skin), and 49.6% achieved
PASI 90, compared to 8.3% and 4.4% on placebo, respectively. Further increases in response
rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra
achieving IGA scores of 0/1, and 64.9% achieving PASI 90. Safety data was consistent with
the Phase 2 FRONTIER 1 and 2 studies. |
| o | A similar proportion of patients experienced
adverse events (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants
experiencing a treatment emergent adverse event (TEAE) at week 16. In addition, positive
topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the
primary endpoint of IGA of 0/1 at week 16 compared to placebo. |
1
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
Nomination
of PN-881, a potential best-in-class oral peptide IL-17 antagonist development candidate; additional discovery programs announced
| · | On
November 21, 2024, the Company announced the nomination of PN-881 following extensive preclinical
studies, including oral stability, potency, tissue distribution, and pharmacokinetics measurements,
and evaluation in immunologic pharmacodynamics and preclinical efficacy models. PN-881 demonstrated
in vitro blockade of IL-17 AA homodimer, FF homodimer and AF heterodimer. It demonstrated
approximately 100-fold greater potency than secukinumab, and similar potency to the most
potent approved antibody drugs and nanobody therapeutics currently in development. |
| · | The Company
expects expect to nominate an oral development candidate in the hepcidin mechanism-based hematology
program in Q4 2025, and an oral peptide-based development candidate in the metabolic/obesity
program in Q2 2025. |
Achievement
of a $165.0 million milestone
Under
the terms of the icotrokinra license and collaboration agreement with JNJ, as amended in November 2024, the Company earned a $165.0
million milestone during Q4 2024. The $165.0 million was received in January 2025.
Recent
and Upcoming Milestones
Rusfertide
| · | Protagonist
held an in-person PV Day on February 6, 2025, in New York; a replay of the webcast is available
at https://lifescievents.com/event/protagonist/ |
| | | |
| · | The
topline data for the Phase 3 VERIFY study2 in PV, which has a 32-week primary
efficacy endpoint, is expected in March of 2025. |
Icotrokinra
| · | Topline results for the Phase 2b ANTHEM multicenter, randomized, placebo- controlled, dose-ranging
study of icotrokinra for the treatment of moderately to severely active ulcerative colitis3,
are expected in March 2025. |
| | | |
| · | Topline results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies4, evaluating the safety and efficacy
of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis, are expected in Q2 2025. |
| · | Further
details of the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies are expected to be presented
at major medical conferences this year. |
2
VERIFY (NCT05210790)
3
ANTHEM (NCT06049017)
4
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
Discovery
Programs
| · | The
Company expects to nominate an oral peptide-based development candidate in the obesity program
in Q2 2025, and an oral development candidate in the hepcidin mechanism-based hematology
program in Q4 2025. |
Fourth Quarter and Full Year 2024
Financial Results
Cash, Cash Equivalents,
and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2024, were $559.2 million as compared
to $341.6 million in the previous year.
| | |
Three Months Ended | | |
Twelve Months Ended | |
| | |
December 31, | | |
December 31, | |
| (in thousands, except per share amounts) | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| License and collaboration revenue | |
$ | 170,638 | | |
$ | 60,000 | | |
$ | 434,433 | | |
$ | 60,000 | |
| Research and development expense | |
$ | 34,904 | | |
$ | 28,899 | | |
$ | 138,128 | | |
$ | 120,161 | |
| General and administrative expense | |
$ | 8,954 | | |
$ | 8,052 | | |
$ | 43,462 | | |
$ | 33,491 | |
| Net income (loss) | |
$ | 131,674 | | |
$ | 27,335 | | |
$ | 275,188 | | |
$ | (78,955 | ) |
| Basic earnings (loss) per share | |
$ | 2.11 | | |
$ | 0.45 | | |
$ | 4.47 | | |
$ | (1.39 | ) |
| Diluted earnings (loss) per share | |
$ | 1.98 | | |
$ | 0.44 | | |
$ | 4.23 | | |
$ | (1.39 | ) |
Revenue: License
and collaboration revenue is derived from the Company’s License and Collaboration Agreement with Johnson & Johnson
(JNJ), as amended in November 2024 (the “JNJ Agreement”), and its Worldwide License and Collaboration Agreement for
Rusfertide with Takeda which became effective in March 2024 (the “Takeda Agreement”). Total License and collaboration
revenue increased by $374.4 million from $60.0 million for the year ended December 31, 2023, to $434.4 million for the year ended
December 31, 2024. The increase was attributable to:
| · | Revenue
recorded during the year ended December 31, 2024, pursuant to the Takeda Agreement, of 269.4
million; and |
| · | Revenue
from the JNJ Agreement which increased by $105.0 million for the year ended December 31,
2024, as compared to the prior year. The revenue reflects the achievement of non-refundable
milestones of $165.0 million and $60.0 million for the years ended December 31, 2024, and
2023, respectively. |
Research and Development
("R&D") Expenses: Increased by $6.0 million and $18.0 million for the fourth quarter and full year 2024, respectively,
from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses.
General and Administrative
("G&A") Expenses: Increased by $0.9 million for the three months ended December 31, 2024, from the prior year period
primarily due to an increase in stock-based compensation. The increase of $10.0 million for the full year 2024 as compared to the prior
year was primarily due to $4.6 million in one-time advisory and legal fees related to the Takeda Collaboration Agreement and an increase
of $4.4 million in stock-based compensation and other personnel-related expenses.
Net Income (Loss):
Net income was $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024 as compared to net
income of $27.3 million, or $0.45 per basic and $0.44 per diluted share, for the fourth quarter of 2023. Net income was $275.2 million,
or $4.47 per basic share and $4.23 per diluted share, for the full year 2024, as compared to a net loss of $(79.0) million, or ($1.39)
per share, for the full year 2023.
About
Protagonist
Protagonist
Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist’s
proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA
potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks
the Interleukin-23 receptor (“IL-23R”) which is licensed to JNJ Innovative Medicines (“JNJ”), formerly Janssen
Biotech, Inc. Following icotrokinra’s joint discovery by Protagonist and JNJ scientists pursuant to the companies’ IL-23R
collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility
for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for
the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals
pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible
for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically
and commercially validated targets, including IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program.
More
information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://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 icotrokinra and rusfertide, the timing of icotrokinra
and rusfertide clinical trials, and timing of developments and announcements 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.
Consolidated
Statements of Operations
(Amounts
in thousands except share and per share data)
| | |
Three Months Ended | | |
Twelve Months Ended | |
| | |
December 31, | | |
December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| License and collaboration revenue | |
$ | 170,638 | | |
$ | 60,000 | | |
$ | 434,433 | | |
$ | 60,000 | |
| Operating expense: | |
| | | |
| | | |
| | | |
| | |
| Research and development (1) | |
| 34,904 | | |
| 28,899 | | |
| 138,128 | | |
| 120,161 | |
| General and administrative (1) | |
| 8,954 | | |
| 8,052 | | |
| 43,462 | | |
| 33,491 | |
| Total operating expense | |
| 43,858 | | |
| 36,951 | | |
| 181,590 | | |
| 153,652 | |
| Income (loss) from operations | |
| 126,780 | | |
| 23,049 | | |
| 252,843 | | |
| (93,652 | ) |
| Interest income | |
| 6,853 | | |
| 4,242 | | |
| 26,315 | | |
| 14,898 | |
| Other income (expense), net | |
| 31 | | |
| 44 | | |
| 250 | | |
| (201 | ) |
| Income (loss) before income tax expense | |
| 133,664 | | |
| 27,335 | | |
| 279,408 | | |
| (78,955 | ) |
| Income tax expense | |
| 1,990 | | |
| - | | |
| 4,220 | | |
| - | |
| Net income (loss) | |
$ | 131,674 | | |
$ | 27,335 | | |
$ | 275,188 | | |
$ | (78,955 | ) |
| Net income (loss) per share, basic | |
$ | 2.11 | | |
$ | 0.45 | | |
$ | 4.47 | | |
$ | (1.39 | ) |
| Net income (loss) per share, diluted | |
$ | 1.98 | | |
$ | 0.44 | | |
$ | 4.23 | | |
$ | (1.39 | ) |
| Weighted-average shares used to compute net income (loss) per share, basic | |
| 62,328,468 | | |
| 60,387,606 | | |
| 61,566,989 | | |
| 56,763,559 | |
| Weighted-average shares used to compute net income (loss) per share, diluted | |
| 66,406,817 | | |
| 61,796,205 | | |
| 65,077,722 | | |
| 56,763,559 | |
(1) Amount
includes non-cash stock-based compensation expense.
Stock-based
Compensation
(In
thousands)
| | |
Three Months Ended | | |
Twelve Months Ended | |
| | |
December 31, | | |
December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Research and development | |
$ | 5,322 | | |
$ | 3,890 | | |
$ | 20,919 | | |
$ | 17,061 | |
| General and administrative | |
| 3,771 | | |
| 2,711 | | |
| 16,635 | | |
| 12,232 | |
| Total stock-based compensation expense | |
$ | 9,093 | | |
$ | 6,601 | | |
$ | 37,554 | | |
$ | 29,293 | |
PROTAGONIST
THERAPEUTICS, INC.
Selected
Consolidated Balance Sheet Data
(In
thousands)
| | |
December 31, | | |
December 31, | |
| | |
2024 | | |
2023 | |
| Cash, cash equivalents and marketable securities | |
$ | 559,165 | | |
$ | 341,617 | |
| Working capital | |
| 544,243 | | |
| 334,303 | |
| Total assets | |
| 744,725 | | |
| 357,951 | |
| Deferred revenue | |
| 30,567 | | |
| - | |
| Accumulated deficit | |
| (340,522 | ) | |
| (615,710 | ) |
| Total stockholders' equity | |
| 675,295 | | |
| 336,677 | |
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Protagonist Therapeutics (NASDAQ:PTGX)
과거 데이터 주식 차트
부터 1월(1) 2025 으로 2월(2) 2025
Protagonist Therapeutics (NASDAQ:PTGX)
과거 데이터 주식 차트
부터 2월(2) 2024 으로 2월(2) 2025
