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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 (PTGX) announced the completion of enrollment and resumption of dosing in the Phase 2 REVIVE study of rusfertide for polycythemia vera (PV) patients. Following a temporary hold, rusfertide restored therapeutic benefits, including effective hematocrit control and reduced red blood cell count. Notably, approximately 85% of patients resumed treatment after the hold, demonstrating rusfertide's rapid therapeutic effect. The results will be presented at the ASCO 2022 Annual Meeting on June 7, highlighting its potential as a transformative treatment for PV.
Protagonist Therapeutics (PTGX) reported its Q1 2022 financial results, highlighting significant developments in its clinical pipeline. The Company initiated the Phase 3 VERIFY study for rusfertide in polycythemia vera and presented positive Phase 2 results for PN-943 in ulcerative colitis. Protagonist received a $25 million milestone from Janssen for the PN-235 psoriasis study. As of March 31, 2022, the Company had $305.3 million in cash and equivalents, sufficient to fund operations through 2024. However, the net loss for the quarter was $20.9 million, improving from $24.0 million in Q1 2021.
Protagonist Therapeutics (PTGX) announced positive results from its Phase 2 IDEAL study of PN-943, an oral treatment for moderate-to-severe ulcerative colitis. The 150 mg twice-daily dose achieved a 27.5% clinical remission, exceeding the 14.5% of the placebo group, and demonstrated significant efficacy across various endpoints. The company plans to initiate a Phase 3 registrational study based on these findings, further validating its gut-restricted alpha-4-beta-7-integrin antagonist approach. Investors can listen to a conference call today at 6:00 p.m. ET.
Protagonist Therapeutics (Nasdaq: PTGX) announced on April 18, 2022, the issuance of inducement awards to three new employees, including Executive Vice President and CFO Asif Ali. The awards consist of options to purchase 82,500 shares and RSUs for 13,750 shares, with an exercise price of $19.19. These awards fall under the Amended and Restated Inducement Plan approved by the Board. Protagonist is advancing its clinical pipeline, including rusfertide, currently in multiple Phase 2 and Phase 3 trials for conditions like polycythemia vera and ulcerative colitis.
Alpha Cognition Inc. (TSX-V: ACOG) announced the appointment of Don Kalkofen as Chief Financial Officer, replacing Jeremy Wright, who will remain as a consultant. Kalkofen has extensive experience in biotechnology finance, most recently as CFO at Protagonist Therapeutics (NASDAQ: PTGX), where he facilitated over $550 million in financing. He will lead Alpha Cognition's financial operations and support strategic growth. In conjunction with his appointment, Kalkofen received 450,000 stock options at $0.93 CAD. CEO Michael McFadden was also appointed to the board of directors.
Protagonist Therapeutics (Nasdaq: PTGX) announced the appointment of Asif Ali as Executive Vice President and CFO, effective mid-April 2022. Asif brings a strong background from Theravance Biopharma, focusing on financial planning and strategic partnerships. He has notable experience supporting product launches and acquisitions at Depomed. CEO Dinesh V. Patel expressed confidence in Asif's potential to enhance the company's financial operations and support its drug development pipeline, which includes therapies for polycythemia vera and ulcerative colitis.
Protagonist Therapeutics (PTGX) has initiated a Phase 2b clinical trial for PN-235, an oral IL-23 receptor antagonist targeting moderate-to-severe plaque psoriasis, with a planned enrollment of 240 patients. The trial commenced on February 3, 2022. The company also announced a $25 million milestone payment from Janssen Biotech for the dosing of the third patient in this trial. Protagonist is eligible for up to $850 million in development-related milestone payments from Janssen, which will oversee all future clinical studies.
Protagonist Therapeutics (PTGX) reported its fourth-quarter and full-year 2021 financial results, highlighting a net loss of $36.9 million in Q4 and $125.6 million for the year. The company emphasized significant progress in its pipeline, particularly with rusfertide entering a Phase 3 study for polycythemia vera and PN-943 completing enrollment for its Phase 2 study in ulcerative colitis. License and collaboration revenue rose to $8.6 million in Q4, up from $5.7 million in the previous year, driven by collaboration with Janssen. Cash reserves of $326.9 million are expected to support operations through 2024.
Protagonist Therapeutics (Nasdaq: PTGX) will be presenting at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 3:00 p.m. EST. The presentation by CEO Dinesh V. Patel will be available via live and archived webcast on their official website.
The company is advancing multiple clinical trials, including the REVIVE Phase 2 trial for rusfertide, aimed at treating polycythemia vera, and IDEAL Phase 2 study for PN-943 in ulcerative colitis.
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