Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Protagonist (Nasdaq:PTGX) reported Q3 2025 results and provided program updates on November 6, 2025. Cash, cash equivalents and marketable securities were $678.8M as of September 30, 2025, expected to fund operations through at least end of 2028.
Key development milestones: NDA (July) and EMA (Sept) submissions for icotrokinra in moderate-to-severe plaque psoriasis; rusfertide granted FDA Breakthrough Therapy designation with a Takeda NDA expected in Q4 2025 and 52-week VERIFY data to be presented at ASH in December; first subject dosed in Phase 1 for oral IL-17 antagonist PN-881; PN-477sc and PN-477o progressing IND-enabling with clinical starts expected in 2026; oral hepcidin candidate nomination expected by year-end.
Protagonist (Nasdaq:PTGX) ha riportato i risultati del terzo trimestre 2025 e fornito aggiornamenti sul programma il 6 novembre 2025. La liquidità, equivalenti di cassa e titoli negoziabili ammontavano a $678.8M al 30 settembre 2025, previsti per finanziare le operazioni almeno fino alla fine del 2028.
Principali traguardi di sviluppo: Domande NDA (luglio) ed EMA (settembre) per icotrokinra nella psoriasi a placche da moderata a grave; rusfertide ha ottenuto lo status FDA Breakthrough Therapy con una NDA di Takeda prevista per il Q4 2025 e i dati VERIFY a 52 settimane saranno presentati all'ASH a dicembre; è stato dosato il primo soggetto nella fase 1 per l'antagonista orale IL-17 PN-881; PN-477sc e PN-477o avanzano verso IND-enabling con l'inizio clinico previsto nel 2026; la nomina del candidato orale alla hepcidina è prevista entro la fine dell'anno.
Protagonist (Nasdaq:PTGX) informó resultados del tercer trimestre de 2025 y proporcionó actualizaciones del programa el 6 de noviembre de 2025. Efectivo, equivalentes de efectivo y valores negociables eran $678.8M al 30 de septiembre de 2025, con expectativa de financiar las operaciones al menos hasta finales de 2028.
Hitos clave de desarrollo: presentaciones de NDA (jul) y EMA (sep) para icotrokinra en psoriasis en placas moderada a grave; rusfertide recibió la designación FDA Breakthrough Therapy con una NDA de Takeda prevista para el Q4 de 2025 y se presentarán datos de VERIFY a 52 semanas en ASH en diciembre; se dosó al primer sujeto en la fase 1 para el antagonista oral IL-17 PN-881; PN-477sc y PN-477o avanzan hacia IND-enabling con inicios clínicos previstos para 2026; se espera la nominación de un candidato oral a hepcidina para finales de año.
Protagonist (Nasdaq:PTGX)는 2025년 3분기 실적을 발표하고 2025년 11월 6일 프로그램 업데이트를 제공했습니다. 현금 및 현금등가물 및 매각가능한 증권은 2025년 9월 30일 기준 $678.8M였으며, 2028년 말까지 운영 자금을 조달할 것으로 예상됩니다.
주요 개발 마일스톤: 소수점 비고 NDA(7월) 및 EMA(9월) 제출은 중등도에서 중증 정도의 판상건선(포스터 플라크) Psoriasis에 대한 icotrokinra; rusfertide는 FDA Breakthrough Therapy 지정을 받았고 Takeda의 NDA는 2025년 4분기에 예상되며 12월 ASH에서 52주 VERIFY 데이터가 발표될 예정; 경구 IL-17 길항제 PN-881의 1상에서 첫 대상자 투여; PN-477sc 및 PN-477o IND-엔블링을 진행 중이며 2026년에 임상 시작이 예상됩니다; 연말까지 경구 hepcidin 후보 지명이 예상됩니다.
Protagonist (Nasdaq:PTGX) a publié les résultats du T3 2025 et fourni des mises à jour du programme le 6 novembre 2025. La trésorerie, les équivalents de trésorerie et les titres négociables s’élevaient à $678.8M au 30 septembre 2025, et devraient financer les opérations jusqu’au moins fin 2028.
Jalons de développement clés : dépôt NDA (juil.) et EMA (sept.) pour icotrokinra dans le psoriasis en plaques modéré à sévère; rusfertide a reçu la désignation FDA Breakthrough Therapy avec une NDA Takeda attendue au T4 2025 et des données VERIFY sur 52 semaines à présenter à l’ASH en décembre; le premier sujet a été dosé dans la phase 1 pour l’antagoniste IL-17 oral PN-881; PN-477sc et PN-477o progressent vers IND-enabled avec un démarrage clinique prévu en 2026; la nomination du candidat oral à l’hepcidine est attendue d’ici la fin de l’année.
Protagonist (Nasdaq:PTGX) meldete die Ergebnisse des dritten Quartals 2025 und gab am 6. November 2025 Program-Upgrades bekannt. Bargeld, Barmitteläquivalente und marktgängige Wertpapiere beliefen sich zum 30. September 2025 auf $678.8M und sollen die Operationen voraussichtlich bis mindestens Ende 2028 finanzieren.
Zentrale Entwicklungsmomente: NDA (Juli) und EMA (Sept) Einreichungen für Icotrokinra bei moderater bis schwerer Plaque-Psoriasis; rusfertide erhielt die FDA Breakthrough Therapy-Deklaration mit einer Takeda-NDA, die voraussichtlich im Q4 2025 kommt, und 52-Wochen-VERIFY-Daten werden im Dezember auf der ASH präsentiert; erster Proband in Phase 1 für den oralen IL-17-Antagonisten PN-881 dosiert; PN-477sc und PN-477o schreiten IND-enabled voran, mit klinischen Starts voraussichtlich 2026; die Nominierung eines oralen Hepcidin-Kandidaten wird bis Jahresende erwartet.
Protagonist (Nasdaq:PTGX) أبلغ عن نتائج الربع الثالث من 2025 وقدم تحديثات البرنامج في 6 نوفمبر 2025. كانت السيولة النقدية وما يعادلها من النقد والأوراق المالية المتداولة $678.8M حتى 30 سبتمبر 2025، من المتوقع أن تمول العمليات حتى على الأقل نهاية 2028.
المعالم التطويرية الأساسية: تقديم NDA (يوليو) وEMA (سبتمبر) لـ icotrokinra في psoriasis اللويحي من الدرجة من متوسطة إلى شديدة؛ rusfertide مُنحت له FDA Breakthrough Therapy designation مع توقع NDA من Takeda في الربع الرابع من 2025 وبيانات VERIFY لمدة 52 أسبوعاً ستُعرض في ASH في ديسمبر؛ تم جر أول Subject في المرحلة 1 لمضاد IL-17 الفموي PN-881؛ PN-477sc و PN-477o يتقدمون نحو IND-enabled مع بدء التجارب السريرية في 2026؛ من المتوقع ترشيح مرشح فموي لله Hepcidin بنهاية السنة.
- Cash balance of $678.8M as of September 30, 2025
- NDA and EMA submissions filed for icotrokinra (July, Sept 2025)
- Rusfertide granted FDA Breakthrough Therapy designation
- First subject dosed in Phase 1 trial of PN-881
- Net loss of $39.3M in Q3 2025, up from $33.2M in Q3 2024
- R&D expense increased to $40.0M in Q3 2025 (+$4.0M YoY)
Insights
Progress on regulatory filings, breakthrough designation, and pipeline activations support a constructive outlook; cash runway appears adequate.
Protagonist advanced multiple clinical and regulatory milestones: submission of an NDA to the U.S. FDA and an EMA application for icotrokinra, Breakthrough Therapy Designation for rusfertide, first dosing in the Phase 1 study of PN-881, and IND-enabling progress for PN-477 programs. These steps convert earlier R&D work into concrete regulatory and clinical events that can unlock partner-driven commercialization and milestone revenue.
Risks and dependencies center on partner actions and upcoming data: regulatory outcomes depend on agency review and the partners (Johnson & Johnson and Takeda) for filing and commercial execution, and the VERIFY 52-week presentation and Takeda's planned
Concrete items to watch: the VERIFY Week 52 oral presentation at ASH on
Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) application was submitted in September
Rusfertide granted breakthrough designation for patients in Polycythemia Vera (PV) and the subject of four presentations including 52-week results of the VERIFY Phase 3 Study at ASH, the 67th Annual American Society of Hematology (ASH) meeting in December
First patient dosed in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist
IND-enabling studies progressing as planned with triple-GLP/GIP/GCG agonists PN-477sc and PN-477o
Oral hepcidin development candidate expected to be nominated by year end
Cash, cash equivalents and marketable securities of
NEWARK, CA / ACCESS Newswire / November 6, 2025 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.
"2025 continues to be a highly productive year with significant accomplishments in both partnered and wholly owned programs," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition to the NDA and EMA submissions for icotrokinra for psoriasis, we are pleased to see our partner Johnson and Johnson expand the ICONIC program into additional IL-23 pathway relevant and validated I&I indications, namely psoriatic arthritis, ulcerative colitis, and Crohn's disease. We, along with our partner Takeda, eagerly await the presentation of the rusfertide 52-week VERIFY data at ASH in December and the NDA filing for rusfertide by year end."
"As icotrokinra and rusfertide move towards potential NDA approval and commercialization in 2026, we shift our attention to the next phase of assets emerging from our validated discovery and development platform. We are pleased to report that the first subject in the Phase 1 trial of oral IL-17 antagonist, PN-881, is dosed. Additionally, the oral and subcutaneous triple GLP/GIP/GCG agonists, PN-477o and PN-477sc, are progressing through
IND-enabling studies as planned, and we remain on track to nominate a development candidate from the oral hepcidin program by year end. I am very proud of the consistent innovation and execution capabilities of the Protagonist team," Patel said.
Third Quarter 2025 Recent Developments and Upcoming Milestones
Icotrokinra: Oral IL-23 Receptor Antagonist
In November, publications of ICONIC-LEAD data through Week 24 (available here) and ICONIC-TOTAL data through Week 16 (available here) were published in the New England Journal of Medicine, and the NEJM Evidence, respectively.
On October 27th, the Company and Johnson and Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC) at the 2025 ACG Annual Scientific Meeting. I cotrokinra demonstrated clinically meaningful outcomes at Week 28 with
31.7% of patients achieving clinical remission and38.1% showing endoscopic improvement versus placebo.On October 26 th , new long-term 52-week data from the Phase 3 ICONIC-TOTAL study, was presented at the 2025 Fall Clinical Dermatology Conference. The data show icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting these high-impact and difficult-to-treat areas of the body.
On October 7th, the Company and its partner JNJ announced Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra in adults with moderately to severely active UC at United European Gastroenterology Week (UEGW) 2025.
On September 17th, new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies, which assessed the superiority of icotrokinra compared to deucravacitinib in patients with moderate-to-severe plaque psoriasis (PsO), was presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Additionally, new long-term 52-week data from the Phase 3 ICONIC-LEAD study investigating icotrokinra in adults and pediatric patients 12 years of age and older (adolescents) with moderate to severe PsO was presented as a late-breaking abstract at EADV.
On September 11th, the Company announced the submission of an application to the European Medicines Agency (EMA) by JNJ seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older (adolescents) with moderate-to-severe PsO.
On July 21st, the Company announced submission of a New Drug Application (NDA) to the U.S. FDA by JNJ seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe PsO.
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders
Clinical data on rusfertide in PV, including the Phase 3 VERIFY study, are the focus of four presentations planned at the 67 th Annual American Society of Hematology (ASH) Annual Meeting being held in Orlando, Florida from December 6-9, 2025. This includes an oral presentation of the durability of response and safety results through week 52 from the VERIFY study.
On August 25th, the Company and its partner Takeda Pharmaceuticals announced rusfertide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of erythrocytosis in patients with PV.
Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, is expected in Q4 of this year.
Discovery and Development Pipeline
The first human subject has been dosed in the Phase 1 trial ( NCT07153146 ) of PN-881, a first-in-class oral IL-17 peptide antagonist, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants.
The triple GLP/GIP/GCG agonists PN-477sc and PN-477o are progressing through IND-enabling studies with clinical study initiation of PN-477sc anticipated by mid-2026, and initiation of PN-477o anticipated in the second half of 2026.
The Company plans to nominate a development candidate ready for IND-enabling studies from the oral hepcidin program by year end.
Third Quarter 2025 Financial Results
Cash, Cash Equivalents and Marketable Securities : Cash, cash equivalents and marketable securities as of September 30, 2025, were
$678.8 million as compared to$559.2 million as of December 31, 2024.
Three Months Ended | Nine Months Ended | |||||||||||||||
(in thousands, except per share amounts) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
(Unaudited) | ||||||||||||||||
License and collaboration revenue | $ | 4,712 | $ | 4,675 | $ | 38,579 | $ | 263,795 | ||||||||
Research and development expense | $ | 40,003 | $ | 35,970 | $ | 112,932 | $ | 103,224 | ||||||||
General and administrative expense | $ | 11,130 | $ | 10,158 | $ | 33,419 | $ | 34,508 | ||||||||
Net (loss) income | $ | (39,339 | ) | $ | (33,210 | ) | $ | (85,765 | ) | $ | 143,514 | |||||
Basic earnings (loss) per share | $ | (0.62) | $ | (0.54) | $ | (1.35) | $ | 2.34 | ||||||||
Diluted earnings (loss) per share | $ | (0.62) | $ | (0.54) | $ | (1.35) | $ | 2.22 | ||||||||
License and Collaboration Revenue :
License and collaboration revenue was
$4.7 million for both the three months ended 2025 and 2024 and was comprised of development services we provided under the Takeda collaboration agreement.License and collaboration revenue of
$38.6 million for the nine months ended September 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$263.8 million for the nine months ended September 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") Expenses : Increased by
$4.0 million and$9.7 million for the three and nine months ended September 30, 2025, respectively, from the prior year periods. The increases were primarily due to increases in drug discovery and pre-clinical research expenses.General and Administrative ("G&A") Expenses : Increased by
$1.0 million for the three months ended September 30, 2025, from the prior year period primarily due to increases in professional services. The decrease of$1.1 million in G&A expenses for the nine months ended September 30, 2025, from the prior year period was primarily due to$4.6 million in one-time advisory and legal fees related to the Takeda collaboration in Q1 24, partially offset by increases in personnel-related expenses and professional services.Net Income (Loss) : Net loss was (
$39.3) million , or ($0.62) per basic and diluted share, for the three months ended September 30, 2025, as compared to a net loss of ($33.2) million , or ($0.54) per basic and diluted share, for the three months ended September 30, 2024. Net loss was ($85.8) million , or ($1.35) per basic and diluted share, for the nine months ended September 30, 2025, as compared to net income of$143.5 million , or$2.34 per basic share and$2.22 per diluted share, for the nine months ended September 30, 2024.
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 the NDA submission for rusfertide expected by end of 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 Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of icotrokinra through Phase 1, with Johnson & Johnson 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 preclinical stage drug discovery programs addressing clinically 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 PN-881, and expectations regarding the icotrokinra and PN-881 development 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 | Nine Months Ended | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
License and collaboration revenue | $ | 4,712 | $ | 4,675 | $ | 38,579 | $ | 263,795 | ||||||||
Operating expense: | ||||||||||||||||
Research and development (1) | 40,003 | 35,970 | 112,932 | 103,224 | ||||||||||||
General and administrative (1) | 11,130 | 10,158 | 33,419 | 34,508 | ||||||||||||
Total operating expense | 51,133 | 46,128 | 146,351 | 137,732 | ||||||||||||
(Loss) income from operations | (46,421 | ) | (41,453 | ) | (107,772 | ) | 126,063 | |||||||||
Interest income | 7,049 | 7,682 | 22,028 | 19,462 | ||||||||||||
Other income, net | 33 | 141 | 151 | 219 | ||||||||||||
(Loss) income before income tax benefit (expense) | (39,339 | ) | (33,630 | ) | (85,593 | ) | 145,744 | |||||||||
Income tax benefit (expense) | - | 420 | (172 | ) | (2,230 | ) | ||||||||||
Net (loss) income | $ | (39,339 | ) | $ | (33,210 | ) | $ | (85,765 | ) | $ | 143,514 | |||||
Net (loss) income per share, basic | $ | (0.62 | ) | $ | (0.54 | ) | $ | (1.35 | ) | $ | 2.34 | |||||
Net (loss) income per share, diluted | $ | (0.62 | ) | $ | (0.54 | ) | $ | (1.35 | ) | $ | 2.22 | |||||
Weighted-average shares used to compute net (loss) income per share, basic | 63,772,332 | 61,767,934 | 63,418,522 | 61,311,310 | ||||||||||||
Weighted-average shares used to compute net (loss) income per share, diluted | 63,772,332 | 61,767,934 | 63,418,522 | 64,611,941 | ||||||||||||
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(Unaudited, in thousands)
Three Months Ended | Nine Months Ended | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Research and development | $ | 6,019 | $ | 5,212 | $ | 20,301 | $ | 15,597 | ||||||||
General and administrative | 4,540 | 4,953 | 14,972 | 12,864 | ||||||||||||
Total stock-based compensation expense | $ | 10,559 | $ | 10,165 | $ | 35,273 | $ | 28,461 | ||||||||
PROTAGONIST THERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheet Data
(Unaudited, In thousands)
September 30, | December 31, | |||||||
2025 | 2024 | |||||||
Cash, cash equivalents and marketable securities$ | $ | 678,820 | $ | 559,165 | ||||
Working capital | 541,482 | 544,243 | ||||||
Total assets | 701,688 | 744,725 | ||||||
Deferred revenue | 16,988 | 30,567 | ||||||
Accumulated deficit | (426,287 | ) | (340,522 | ) | ||||
Total stockholders' equity | 645,437 | 675,295 | ||||||
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
FAQ
What did Protagonist announce about icotrokinra (PTGX) in November 2025?
How much cash does Protagonist (PTGX) have and how long is the runway?
What is the status of rusfertide and its regulatory pathway for PTGX/Takeda in 2025?
Has Protagonist started clinical trials for any new candidates as of Q3 2025?
When are Protagonist's PN-477 clinical studies expected to begin?
What were Protagonist's Q3 2025 profitability and major expense trends (PTGX)?
