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Protagonist Therapeutics develops peptide-based therapeutics using a proprietary discovery platform, with programs spanning inflammation and immunology, hematology and metabolic disease. Company news centers on ICOTYDE™ (icotrokinra), an oral IL-23 receptor-targeted peptide approved for moderate-to-severe plaque psoriasis, and rusfertide, a hepcidin mimetic peptide for polycythemia vera developed with Takeda.
Recurring updates also cover collaboration economics with Johnson & Johnson's Janssen Biotech and Takeda, clinical and regulatory milestones, R&D spending on wholly owned discovery programs, financial results, investor conference participation and equity-based inducement awards under Nasdaq rules.
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.
Protagonist Therapeutics has announced an upcoming investor event scheduled for February 6, 2025, in New York, offering both in-person and virtual attendance options. The event will feature expert insights from Dr. Andrew Kuykendall (Moffitt Cancer Center) and Dr. Joseph Michael Scandura (Weill Cornell Medicine) focusing on polycythemia vera (PV), a rare chronic blood disorder, and the potential of their drug candidate Rusfertide.
The presentation will cover comprehensive data from the Phase 2 PACIFIC and REVIVE trials, along with details about the Phase 3 VERIFY study design. Notably, the VERIFY study's topline results are expected in March 2025. Management will also discuss Rusfertide's commercial potential. The event will include a Q&A session and an informal lunch for in-person attendees.
Protagonist Therapeutics (Nasdaq:PTGX) announced the issuance of inducement awards to Newman Yeilding, M.D., who was appointed as Executive Vice President and Chief Scientific Officer. The awards, granted on January 2, 2025, include options to purchase 38,520 shares at an exercise price of $38.98 per share and 31,779 restricted stock units (RSUs).
The stock options vest over four years, with 25% vesting after the first year and the remainder vesting monthly over three years. The RSUs will vest annually over four years, with one-fourth vesting each year. Dr. Yeilding previously served as the Company's Chief Scientific Advisor from August 1, 2024, through January 1, 2025. The awards were granted under the company's Amended and Restated Inducement Plan and approved by the compensation committee.
Protagonist Therapeutics (PTGX) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 12-16, 2025, in San Francisco. Dinesh V. Patel, Ph.D., President and CEO, will deliver a company overview presentation on Tuesday, January 14, at 8:15 AM PT.
The presentation will be available via webcast, and the company will engage in one-on-one meetings during the conference. Interested parties can arrange meetings through their J.P. Morgan representatives. A replay of the presentation will be accessible on the Company's Investor Relations Events and Presentations webpage for one year after the event.
Protagonist Therapeutics announced final data from the rusfertide Phase 2 REVIVE study for polycythemia vera (PV) treatment at the ASH 2024 Annual Meeting. The study demonstrated significant results with 54% of patients achieving durable hematocrit control for over 2.5 years.
The trial included 70 patients in Part 1 (dose-finding), 59 in Part 2 (randomized withdrawal), and 58 in Part 3 (open-label extension). Key findings showed hematocrit control below 45%, reduced phlebotomy needs from >5/year to 1/year, and improved patient-reported outcomes. The treatment was well-tolerated, with most adverse events being mild to moderate.The company expects VERIFY Phase 3 topline results in Q1 2025.
Protagonist Therapeutics announced its participation in the 7th Annual Evercore ISI HealthCONx Conference scheduled for December 3-5, 2024, in Coral Gables, Florida. Dinesh V. Patel, Ph.D., President and CEO, will engage in a fireside chat on Tuesday, December 3 at 8:45 A.M. ET. The presentation will be accessible via webcast, and the company will also conduct one-on-one meetings during the conference. A replay of the fireside chat will remain available on the company's Investor Relations Events and Presentations webpage for one year after the event.
Protagonist Therapeutics announced PN-881, a potential best-in-class oral peptide IL-17 antagonist, as a development candidate for immune-mediated skin diseases. The drug has shown superior potency compared to anti-IL-17 oral small molecules and comparable effectiveness to injectable antibody treatments. PN-881 demonstrated effective blockade of all three therapeutically relevant IL-17 dimers, with approximately 100-fold greater potency than secukinumab. The company plans to initiate Phase 1 clinical trials in Q4 2025, with potential expansion into psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthropathies based on psoriasis study results.
Protagonist Therapeutics has scheduled a conference call and webcast for November 21st at 4:30 pm ET to announce their new oral peptide IL-17 antagonist development candidate. During the presentation, the company will share in vitro and pre-clinical proof-of-concept study results.
US investors can dial 1-877-407-0752, while international investors can access the call at 1-201-389-0912 using Conference ID 13750274. The webcast will be available through a provided link, and a replay will be accessible on the Company's Investor Relations Events and Presentations webpage after the event.
Protagonist Therapeutics announced positive Phase 3 results for icotrokinra (JNJ-2113) in treating plaque psoriasis. The ICONIC-LEAD study showed 64.7% of patients achieved clear/almost clear skin (IGA 0/1) and 49.6% achieved PASI 90 at week 16, compared to 8.3% and 4.4% on placebo. By week 24, these rates increased to 74.1% and 64.9% respectively. The ICONIC-TOTAL study also met its primary endpoint. Safety data aligned with Phase 2 results, with similar adverse event rates between treatment and placebo groups. The company earned a $165 million milestone payment, with potential for additional $630 million in future milestones and 6-10% royalties on worldwide sales.
Protagonist Therapeutics (PTGX) reported Q3 2024 financial results with key upcoming milestones. The company expects top-line results for JNJ-2113 Phase 3 trials in psoriasis in Q4 2024, Phase 2b in ulcerative colitis in Q1 2025, and rusfertide Phase 3 in polycythemia vera in Q1 2025. Financial highlights include cash position of $583.3 million, expected to last through 2027. Q3 2024 showed revenue of $4.7 million, R&D expenses of $36 million, and net loss of $33.2 million ($0.54 per share). The company recognized $263.8 million in revenue for the nine months ended September 30, 2024, largely from the Takeda collaboration agreement.