On August 6, 2025 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Protagonist, AUG 6, 2025, View Source [SID1234654847]).

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"Thus far, 2025 has been a year of breakthrough accomplishments for Protagonist, as we saw rusfertide the topic of the prestigious ASCO (Free ASCO Whitepaper) 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) (Free ASCO Whitepaper) 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.

Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist

· 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.

Development Pipeline: First-in-Class Oral IL-17 Peptide Antagonist (PN-881) & GLP-1, GIP, & GCG Triple Agonist (PN-477)

· 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:

o Potently and selectively binds IL-17A and -17F, blocking the three dimeric forms of the cytokine.

o Nanomolar to picomolar in vitro potency comparable to bimekizumab and superior (70-fold) to secukinumab.

o Metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.

o Pharmocodynamic-based target engagement in a mouse IL-17 challenge model after oral dosing.

o Dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.

Second Quarter 2025 Financial Results

· 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.