Protagonist Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Protagonist Therapeutics (NASDAQ:PTGX) reported Q2 2025 financial results and significant pipeline progress. The company submitted an NDA for icotrokinra to treat psoriasis and plans to present Phase 2b ANTHEM trial data in ulcerative colitis at UEGW. Their Phase 3 VERIFY trial data for rusfertide in polycythemia vera was presented at ASCO, with NDA filing expected in Q4.
Financial highlights include $673.0 million in cash and equivalents (vs $559.2M in Dec 2024), providing runway through 2028. Q2 revenue was $5.5 million, with a net loss of $34.8 million ($0.55 per share). R&D expenses increased to $37.0 million, while G&A expenses rose to $10.6 million.
The company also advanced its pipeline with PN-477, a triple agonist anti-obesity peptide, and PN-881, an oral IL-17 peptide antagonist showing promising preclinical results.
Protagonist Therapeutics (NASDAQ:PTGX) ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti progressi nel suo portafoglio di progetti. L'azienda ha presentato una NDA per icotrokinra, destinata al trattamento della psoriasi, e prevede di presentare i dati della fase 2b dello studio ANTHEM sulla colite ulcerosa al congresso UEGW. I dati della fase 3 VERIFY per rusfertide nella policitemia vera sono stati presentati all'ASCO, con la prevista sottomissione della NDA nel quarto trimestre.
Tra i dati finanziari principali, la società dispone di 673,0 milioni di dollari in liquidità e equivalenti (rispetto a 559,2 milioni di dollari a dicembre 2024), garantendo risorse fino al 2028. Il fatturato del secondo trimestre è stato di 5,5 milioni di dollari, con una perdita netta di 34,8 milioni di dollari (0,55 dollari per azione). Le spese per ricerca e sviluppo sono aumentate a 37,0 milioni di dollari, mentre le spese generali e amministrative sono salite a 10,6 milioni di dollari.
L'azienda ha inoltre fatto progressi nel suo portafoglio con PN-477, un peptide triplo agonista anti-obesità, e PN-881, un antagonista orale del peptide IL-17 che mostra risultati preclinici promettenti.
Protagonist Therapeutics (NASDAQ:PTGX) informó los resultados financieros del segundo trimestre de 2025 y avances significativos en su cartera de proyectos. La compañía presentó una NDA para icotrokinra para el tratamiento de la psoriasis y planea presentar datos del ensayo de fase 2b ANTHEM en colitis ulcerosa en UEGW. Los datos del ensayo de fase 3 VERIFY para rusfertide en policitemia vera se presentaron en ASCO, con la presentación de la NDA prevista para el cuarto trimestre.
Entre los aspectos financieros destacados, la empresa cuenta con 673,0 millones de dólares en efectivo y equivalentes (frente a 559,2 millones en diciembre de 2024), lo que proporciona financiación hasta 2028. Los ingresos del segundo trimestre fueron de 5,5 millones de dólares, con una pérdida neta de 34,8 millones de dólares (0,55 dólares por acción). Los gastos en I+D aumentaron a 37,0 millones de dólares, mientras que los gastos generales y administrativos subieron a 10,6 millones de dólares.
La compañía también avanzó en su cartera con PN-477, un péptido triple agonista anti-obesidad, y PN-881, un antagonista oral del péptido IL-17 que muestra resultados preclínicos prometedores.
Protagonist Therapeutics (NASDAQ:PTGX)는 2025년 2분기 재무 실적과 주요 파이프라인 진전을 발표했습니다. 회사는 건선 치료용 icotrokinra에 대한 NDA를 제출했으며, UEGW에서 궤양성 대장염에 대한 2b상 ANTHEM 시험 데이터를 발표할 계획입니다. 다혈구증 치료를 위한 rusfertide의 3상 VERIFY 시험 데이터는 ASCO에서 발표되었으며, 4분기에 NDA 제출이 예상됩니다.
재무 하이라이트로는 6억 7,300만 달러의 현금 및 현금성 자산(2024년 12월의 5억 5,920만 달러 대비)을 보유해 2028년까지 운영이 가능합니다. 2분기 매출은 550만 달러, 순손실은 3,480만 달러(주당 0.55달러)였습니다. 연구개발 비용은 3,700만 달러로 증가했고, 일반관리비는 1,060만 달러로 상승했습니다.
또한 회사는 삼중 작용 항비만 펩타이드인 PN-477과 유망한 전임상 결과를 보이는 경구용 IL-17 펩타이드 길항제 PN-881으로 파이프라인을 확장했습니다.
Protagonist Therapeutics (NASDAQ:PTGX) a publié ses résultats financiers du deuxième trimestre 2025 ainsi que des avancées significatives dans son pipeline. La société a soumis une NDA pour icotrokinra destinée au traitement du psoriasis et prévoit de présenter les données de l’essai de phase 2b ANTHEM sur la colite ulcéreuse lors de l’UEGW. Les données de l’essai de phase 3 VERIFY pour rusfertide dans la polyglobulie vraie ont été présentées à l’ASCO, avec un dépôt de NDA attendu au quatrième trimestre.
Les points financiers clés incluent 673,0 millions de dollars en liquidités et équivalents (contre 559,2 M$ en décembre 2024), assurant une trésorerie jusqu’en 2028. Le chiffre d’affaires du deuxième trimestre s’est élevé à 5,5 millions de dollars, avec une perte nette de 34,8 millions de dollars (0,55 $ par action). Les dépenses en R&D ont augmenté à 37,0 millions de dollars, tandis que les frais généraux et administratifs ont atteint 10,6 millions de dollars.
La société a également fait progresser son pipeline avec PN-477, un peptide triple agoniste anti-obésité, et PN-881, un antagoniste oral du peptide IL-17 montrant des résultats précliniques prometteurs.
Protagonist Therapeutics (NASDAQ:PTGX) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 sowie bedeutende Fortschritte in der Pipeline. Das Unternehmen reichte eine NDA für icotrokinra zur Behandlung von Psoriasis ein und plant, die Daten der Phase-2b-ANTHEM-Studie zur Colitis ulcerosa auf dem UEGW vorzustellen. Die Daten der Phase-3-VERIFY-Studie für rusfertide bei Polycythaemia vera wurden auf der ASCO präsentiert, mit einer erwarteten NDA-Einreichung im vierten Quartal.
Finanzielle Highlights umfassen 673,0 Millionen US-Dollar an liquiden Mitteln und Äquivalenten (gegenüber 559,2 Mio. USD im Dezember 2024), was eine Finanzierung bis 2028 sichert. Der Umsatz im zweiten Quartal betrug 5,5 Millionen US-Dollar, mit einem Nettoverlust von 34,8 Millionen US-Dollar (0,55 USD pro Aktie). Die F&E-Ausgaben stiegen auf 37,0 Millionen US-Dollar, während die Verwaltungs- und allgemeinen Kosten auf 10,6 Millionen US-Dollar zunahmen.
Das Unternehmen machte zudem Fortschritte in der Pipeline mit PN-477, einem dreifachen Agonisten-Peptid gegen Fettleibigkeit, und PN-881, einem oralen IL-17-Peptid-Antagonisten, der vielversprechende präklinische Ergebnisse zeigt.
- Strong cash position of $673.0 million providing runway through 2028
- NDA submission for icotrokinra in psoriasis completed
- Positive Phase 3 VERIFY trial data for rusfertide presented at ASCO plenary session
- Development of potentially best-in-class triple agonist anti-obesity peptide PN-477
- Pipeline expansion with promising preclinical data for oral IL-17 antagonist PN-881
- Increased net loss of $34.8 million in Q2 2025 compared to $30.6 million in Q2 2024
- Higher R&D expenses at $37.0 million vs $33.5 million year-over-year
- Significant decrease in license and collaboration revenue for H1 2025 ($33.9M) compared to H1 2024 ($259.1M)
Insights
Protagonist shows strong pipeline progress with two NDA submissions and healthy financials, signaling positive long-term outlook despite current losses.
Protagonist Therapeutics is making remarkable progress with multiple late-stage assets advancing toward commercialization. The company has submitted an NDA for icotrokinra (with partner Johnson & Johnson) for psoriasis and is on track for a Q4 NDA filing for rusfertide (with partner Takeda) in polycythemia vera (PV). The rusfertide data was significant enough to warrant presentation at the prestigious ASCO plenary session, indicating strong clinical results and potential practice-changing implications.
The company's financial position is exceptionally strong with
While quarterly revenue was modest at
The obesity program (PN-477) targeting GLP-1, GIP, and GCG receptors is particularly noteworthy as it enters an extremely lucrative market with both oral and injectable formulations. Their IL-17 oral peptide antagonist also shows promising preclinical data with potency comparable or superior to existing biologics but in a convenient oral formulation. These early-stage assets provide significant optionality beyond their lead programs.
Strong cash position of $673M through 2028 and multiple late-stage assets nearing approval outweigh short-term losses.
From a financial perspective, Protagonist presents a compelling investment case despite current quarterly losses. The company's cash position of
The quarterly revenue of
The partnership strategy has been executed masterfully, with Johnson & Johnson advancing icotrokinra and Takeda advancing rusfertide while Protagonist retains full ownership of early-stage assets with significant market potential. This balanced approach mitigates development risk while preserving substantial upside. The
R&D expenses increased
The company's strategic focus on peptide therapeutics across multiple high-value indications (immunology, hematology, and metabolic disease) provides multiple shots on goal and diversification that's rare for a company of this size. With rusfertide and icotrokinra approaching potential approvals and wholly-owned early-stage assets advancing, Protagonist's financial metrics should improve substantially over the coming years.
NDA for icotrokinra for the treatment of adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO) submitted to U.S. FDA in July
ANTHEM Phase 2b trial data of icotrokinra in ulcerative colitis scheduled for an oral presentation at the 33rd United European Gastroenterology Week (UEGW) on October 7th
Phase 3 VERIFY trial data set of rusfertide in polycythemia vera (PV) presented during plenary session at ASCO; U.S. NDA filing on track for Q4
Cash, cash equivalents and marketable securities of
NEWARK, CA / ACCESS Newswire / August 6, 2025 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the second quarter ended June 30, 2025, and provided a corporate update.
"Thus far, 2025 has been a year of breakthrough accomplishments for Protagonist, as we saw rusfertide the topic of the prestigious ASCO Plenary Session in May, the announcement of an oral and injectable triple agonist anti-obesity peptide development candidate in June, and most recently the first ever NDA filing of icotrokinra for psoriasis last month," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "Over the coming months, we look forward to the NDA filing of rusfertide for polycythemia vera, and advancing our wholly owned early-stage assets PN-881 and PN-477 into clinical and IND-enabling studies respectively."
Second Quarter 2025 Recent Developments and Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
The full data set from the positive Phase 3 VERIFY trial of rusfertide in PV was presented during the prestigious plenary session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 1st.
The Company hosted an investor conference call on Monday, June 2nd discussing data shared during the plenary presentation. A replay of the call and accompanying presentation is available on the Company's Investor Relations Events and Presentations webpage here.
Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, expected in Q4 of this year.
On July 21st, the Company and its partner Johnson and Johnson announced the first icotrokinra NDA filing for the treatment of adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO). The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2.
On May 9th, data from the Phase 3 ICONIC-TOTAL study in difficult-to-treat scalp and genital psoriasis was presented at the Society for Investigative Dermatology Annual Meeting held in San Diego from May 7-10th.
On April 10th, data from the adolescent cohort of the Phase 3 ICONIC-LEAD study in moderate-to-severe plaque psoriasis was presented as a late-breaking abstract at the 2025 World Congress of Pediatric Dermatology (WCPD).
On March 10th, positive top line results from the Phase 2b ANTHEM trial in moderately to severely active ulcerative colitis (UC) were announced. The full data set is scheduled for an oral presentation at the 33rd United European Gastroenterology Week (UEGW) on October 7th.
On June 30th, the Company hosted an investor call announcing the selection of PN-477, a potential best-in-class GLP-1, GIP, GCG receptor triple agonist peptide with oral and subcutaneous routes of administration, as a development candidate for the treatment of obesity. A replay of the call and accompanying presentation is available on the Company's Investor Relations Events and Presentations webpage here.
On May 9th, preclinical data on PN-881 was presented at the Society for Investigative Dermatology (SID) Annual Meeting held in San Diego from May 7-10th. Key takeaways from the pre-clinical characterization of the IL-17 oral peptide antagonist PN-881:
Potently and selectively binds IL-17A and -17F, blocking the three dimeric forms of the cytokine.
Nanomolar to picomolar in vitro potency comparable to bimekizumab and superior (70-fold) to secukinumab.
Metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.
Pharmocodynamic-based target engagement in a mouse IL-17 challenge model after oral dosing.
Dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2025, were
$673.0 million as compared to$559.2 million as of December 31, 2024.
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(in thousands, except per share amounts) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
(Unaudited) | ||||||||||||||||
License and collaboration revenue | $ | 5,546 | $ | 4,167 | $ | 33,867 | $ | 259,120 | ||||||||
Research and development expense | $ | 37,036 | $ | 33,520 | $ | 72,929 | $ | 67,254 | ||||||||
General and administrative expense | $ | 10,551 | $ | 9,440 | $ | 22,289 | $ | 24,350 | ||||||||
Net (loss) income | $ | (34,771 | ) | $ | (30,616 | ) | $ | (46,426 | ) | $ | 176,724 | |||||
Basic (loss) earnings per share | $ | (0.55) | $ | (0.50) | $ | (0.73) | $ | 2.89 | ||||||||
Diluted (loss) earnings per share | $ | (0.55) | $ | (0.50) | $ | (0.73) | $ | 2.77 | ||||||||
License and Collaboration Revenue:
License and collaboration revenue of
$5.5 million and$4.2 million for the second quarter of 2025 and 2024, respectively, was comprised of development services we provided under the Takeda collaboration agreement.License and collaboration revenue of
$33.9 million for the six months ended June 30, 2025 was comprised of (i) proportional recognition of a$25 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period. License and collaboration revenue of$259.1 million for the six months ended June 30, 2024 included (i)$254.1 million of the$300.0 million initial transaction price for the Takeda collaboration agreement allocated to the rusfertide license upon effectiveness of the agreement, and (ii) development services we provided during the period.
Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to increases in pre-clinical and drug discovery research expenses, including costs related to our new product candidates, IL-17 oral peptide antagonist PN-881 and obesity triple agonist peptide PN-477, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial.
General and Administrative ("G&A") Expense: The increase in G&A expense for the second quarter of 2025 from the prior year period was primarily due to increases in stock-based compensation and other personnel-related expenses. The decrease in G&A expense for the six months ended June 30, 2025 from the prior year period was primarily due to
$4.6 million in advisory and legal fees recognized in 2024 related to the Takeda collaboration, partially offset by increases in stock-based compensation expense and other personnel-related expenses.Net (Loss) Income: Net loss was
$34.8 million , or$0.55 per basic and diluted share, for the second quarter of 2025 as compared to net loss of$30.6 million , or$0.50 per basic and diluted share, for the second quarter of 2024. Net loss was$46.4 million , or$0.73 per basic and diluted share, for the six months ended June 30, 2025 as compared to net income of$176.7 million , or$2.89 per basic share and$2.77 per diluted share, for the six months ended June 30, 2024, which included recognition of$259.1 million revenue related to the Takeda collaboration agreement upfront payment of$300.0 million .
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 a New Drug Application (NDA) for icotrokinra submitted to the FDA in July and an NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") is licensed to J&J 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 in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing biologically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin 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 ext 1
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
License and collaboration revenue | $ | 5,546 | $ | 4,167 | $ | 33,867 | $ | 259,120 | ||||||||
Operating expense: | ||||||||||||||||
Research and development (1) | 37,036 | 33,520 | 72,929 | 67,254 | ||||||||||||
General and administrative (1) | 10,551 | 9,440 | 22,289 | 24,350 | ||||||||||||
Total operating expense | 47,587 | 42,960 | 95,218 | 91,604 | ||||||||||||
(Loss) income from operations | (42,041 | ) | (38,793 | ) | (61,351 | ) | 167,516 | |||||||||
Interest income | 7,406 | 7,404 | 14,979 | 11,780 | ||||||||||||
Other income, net | 36 | 97 | 118 | 78 | ||||||||||||
(Loss) income before income tax expense (benefit) | (34,599 | ) | (31,292 | ) | (46,254 | ) | 179,374 | |||||||||
Income tax expense (benefit) | 172 | (676 | ) | 172 | 2,650 | |||||||||||
Net (loss) income | $ | (34,771 | ) | $ | (30,616 | ) | $ | (46,426 | ) | $ | 176,724 | |||||
Net (loss) income per share, basic | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.89 | |||||
Net (loss) income per share, diluted | $ | (0.55 | ) | $ | (0.50 | ) | $ | (0.73 | ) | $ | 2.77 | |||||
Weighted-average shares used to compute net (loss) income per share, basic | 63,510,537 | 61,305,289 | 63,238,682 | 61,080,489 | ||||||||||||
Weighted-average shares used to compute net (loss) income per share, diluted | 63,510,537 | 61,305,289 | 63,238,682 | 63,909,633 | ||||||||||||
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(Unaudited, in thousands)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Research and development | $ | 6,291 | $ | 5,097 | $ | 14,282 | $ | 10,385 | ||||||||
General and administrative | 4,621 | 3,847 | 10,432 | 7,911 | ||||||||||||
Total stock-based compensation expense | $ | 10,912 | $ | 8,944 | $ | 24,714 | $ | 18,296 | ||||||||
PROTAGONIST THERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheet Data
(Unaudited, In thousands)
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Cash, cash equivalents and marketable securities$ | 672,958 | $ | 559,165 | |||||
Working capital | 567,019 | 544,243 | ||||||
Total assets | 718,006 | 744,725 | ||||||
Deferred revenue | 20,063 | 30,567 | ||||||
Accumulated deficit | (386,948 | ) | (340,522 | ) | ||||
Total stockholders' equity | 668,018 | 675,295 | ||||||
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
FAQ
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