Protagonist Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Rhea-AI Summary
Protagonist Therapeutics (NASDAQ:PTGX) reported significant financial and operational achievements for Q4 and full year 2024. The company earned a $165.0 million milestone for icotrokinra in Q4 2024 and nominated PN-881 as a development candidate for oral IL-17 receptor antagonist.
Key financial highlights include cash position of $559.2 million as of December 31, 2024, providing runway through 2028. The company reported total license and collaboration revenue of $434.4 million for 2024, a significant increase from $60.0 million in 2023. Net income reached $275.2 million ($4.23 per diluted share) for 2024, compared to a net loss of $(79.0) million in 2023.
Important upcoming milestones include topline results for rusfertide Phase 3 VERIFY trial in polycythemia vera and icotrokinra Phase 2b ANTHEM trial in ulcerative colitis, both expected in March 2025.
Positive
- Earned $165.0 million milestone payment for icotrokinra in Q4 2024
- Strong cash position of $559.2 million plus $165.0 million milestone payment
- Revenue increased to $434.4 million in 2024 from $60.0 million in 2023
- Net income of $275.2 million in 2024 versus $79.0 million loss in 2023
- Secured $300.0 million upfront payment from Takeda collaboration agreement
Negative
- R&D expenses increased by $18.0 million for full year 2024
- G&A expenses increased by $10.0 million for full year 2024
News Market Reaction 1 Alert
On the day this news was published, PTGX gained 0.68%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
NEWARK, CA / ACCESS Newswire / 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 studies1in moderate to severe plaque psoriasis, were reported in Q4 2024.
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), and49.6% achieved PASI 90, compared to8.3% and4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and64.9% achieving PASI 90. Safety data was consistent with the Phase 2 FRONTIER 1 and 2 studies.A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with
49.3% and49.1% 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.
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 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
Under the terms of the icotrokinra license and collaboration agreement with JNJ, as amended in November 2024, the Company earned a
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.
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
| 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
Revenue recorded during the year ended December 31, 2024, pursuant to the Takeda Agreement, of
$269.4 million ; andRevenue 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
General and Administrative ("G&A") Expenses: Increased by
Net Income (Loss): Net income was
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.
Contact Information
Corey Davis Ph.D.
Investor Relations Contact - LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Virginia Amann
Media Relations Contact - ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1
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 |
|
|
|
| |||
Cash, cash equivalents and marketable securities |
| $ | 559,165 |
|
| $ |
|
|
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 |
|
|
|
|
|
|
|
|
| |
1 ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
2 VERIFY (NCT05210790)
3 ANTHEM (NCT06049017)
4 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
FAQ
What were Protagonist's (PTGX) Q4 2024 financial results?
When will PTGX announce topline results for rusfertide Phase 3 VERIFY trial?
What is the value of Protagonist's Takeda collaboration agreement for rusfertide?
What was PTGX's revenue growth from 2023 to 2024?
When will Protagonist report icotrokinra Phase 2b ANTHEM trial results?
