On May 6, 2025 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, Protagonist, MAY 6, 2025, View Source [SID1234652591]).

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"Protagonist is off to a very strong 2025 with multiple transformational events in the first quarter for our two late-stage partnered assets, rusfertide and icotrokinra which are progressing to NDA filings by year end," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "We look forward to presenting data from rusfertide’s Phase 3 VERIFY study at a plenary session at ASCO (Free ASCO Whitepaper) on June 1st. We’re very pleased with the highly positive results from the icotrokinra Phase 2b ANTHEM study in ulcerative colitis which lay the foundation for additional studies in both UC and Crohn’s. We are continuing to increasingly focus on advancement of our pre-clinical candidates including the oral IL-17 antagonist PN-881, as well as additional candidates emerging from our oral anti-obesity and oral hepcidin programs. We are fortunate to be in a very strong cash position, allowing us to independently and rapidly progress our early-stage pipeline into value-creating clinical safety and proof-of-concept studies starting with PN-881 in 2025."

First Quarter 2025 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

Abstract accepted for presentation at the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

· Data from the Phase 3 VERIFY trial of rusfertide in PV has been accepted for a prestigious oral presentation during the plenary session on Sunday, June 1 at 2:09PM CDT at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

· The Company will host an investor conference call Monday, June 2, 2025, at 8AM EDT to discuss data shared during the plenary presentation:

Conference Call and Webcast Details

US-based Investors: 1-877-300-8521

International Investors:1-412-317-6026

Conference Call ID: 10199589

The webcast link for the event can be found here: View Source;tp_key=360d3b714d

A replay of the presentation will be available on the Company’s Investor Relations Events and Presentations webpage following the event.

· On March 3rd, the Company announced positive topline results from the Phase 3 VERIFY study. Key findings include:

o Study met primary endpoint with a significantly higher proportion of clinical responders1 on rusfertide compared to placebo during weeks 20-32 (p<0.0001)
o Study met all four key secondary endpoints (weeks 0-32)
– Phlebotomy rate – EU primary endpoint (p<0.0001)
– Hematocrit control
– Patient-reported outcomes of PROMIS Fatigue and MFSAF TSS-7
o Safety profile consistent with previous rusfertide studies, with no new safety signals

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

o 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).

o On March 10th, positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra in adults with moderately to severely active ulcerative colitis (UC) were announced. The full data set is expected at a medical conference later this year.

o On March 8th, data from the adult cohort of the Phase 3 ICONIC-LEAD study in moderate-to-severe plaque psoriasis were presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

First Quarter 2025 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2025, were $697.9 million as compared to $559.2 million as of December 31, 2024.

Three Months Ended
March 31,
(in thousands, except per share amounts) 2025 2024

(Unaudited)
License and collaboration revenue $ 28,321 $ 254,953
Research and development expense $ 35,893 $ 33,734
General and administrative expense $ 11,738 $ 14,910
Income tax expense $ – $ 3,326
Net (loss) income $ (11,655 ) $ 207,340
Basic (loss) earnings per share $ (0.19 ) $ 3.41
Diluted (loss) earnings per share $ (0.19 ) $ 3.26

· License and Collaboration Revenue: License and collaboration revenue of $28.3 million for the period ended March 31, 2025, consisted of: (i) $22.8 million related to proportional recognition of the $25 million milestone earned in Q1 2025 but payable following completion of the VERIFY clinical study report, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period. License and collaboration revenue of $255.0 million for the period ended March 31, 2024 consisted of: (i) $254.1 million of the $300.0 million transaction price for the Takeda Collaboration Agreement allocated to the rusfertide license delivered to Takeda upon effectiveness of the agreement on March 15, 2024, and (ii) $0.9 million allocated to development services provided by us under the agreement during the last two weeks of March 2024.

· Research and Development ("R&D") Expenses: The increase in R&D expenses from the prior year period was primarily due to an increase in pre-clinical and drug discovery research expenses, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.

· General and Administrative ("G&A") Expenses: The decrease in G&A expenses from the prior year period was primarily due to $4.6 million in advisory and legal fees related to the Takeda collaboration, partially offset by an increase in stock-based compensation expense.

· Income Tax Expense: Income tax expense of $3.3 million for the period ended March 31, 2024, consisted of tax related to the upfront payment earned under the Takeda collaboration agreement.

· Net (Loss) Income: Net loss was $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025 as compared to net income of $207.3 million, or $3.41 per basic share and $3.26 per diluted share, for the first quarter of 2024.