Protagonist Therapeutics, Inc., a biotechnology firm listed on NASDAQ under the ticker PTGX, has revealed its financial outcomes for the first quarter ending March 31, 2024, alongside significant corporate updates.
According to Dinesh V. Patel, Ph.D., the CEO and President, the first quarter of 2024 was notably productive for the company. A key highlight was entering a global licensing and collaboration agreement with Takeda Pharmaceutical Company for the development and commercialization of rusfertide. This strategic partnership is expected to facilitate reinvestment into Protagonist’s core peptide therapeutics and support the creation of a new pipeline of promising drug candidates. An oral IL-17 antagonist development candidate is anticipated to be nominated before the end of 2024.
Additionally, the company's collaboration with Johnson & Johnson (J&J) has been progressing well, with JNJ-2113, an oral IL-23 receptor antagonist peptide, being a focal point. JNJ-2113 has shown promise in maintaining skin clearance in patients with moderate-to-severe plaque psoriasis through a year-long period, potentially positioning it as a leading oral therapeutic for psoriasis. Results from Phase 2 trials published in the New England Journal of Medicine and presented at the American Academy of Dermatology 2024 Annual Meeting have been encouraging. Protagonist is also exploring the application of JNJ-2113 across other IL-23-mediated disorders, including ongoing Phase 2b trials for ulcerative colitis.
Key developments and future milestones for the first quarter of 2024 include:
Rusfertide: Protagonist and Takeda formalized a worldwide license and collaboration agreement for rusfertide on January 31, 2024. This agreement included an upfront cash payment of $300 million, and Protagonist may receive up to $330 million in development, regulatory, and sales milestones, leading to a potential total value of $630 million. Protagonist also possesses the right to exit the 50:50 profit-sharing model, which would then entitle them to additional cash payments and enhanced milestone payments, potentially adding up to $975 million, along with royalties on worldwide sales. Phase 2 REVIVE trial results for rusfertide were published in February 2024, and top-line data for the VERIFY study is expected by the first quarter of 2025.
JNJ-2113: Phase 2b FRONTIER 1 trial results for JNJ-2113 were released in February 2024, and subsequent data from the FRONTIER 2 long-term extension study was presented in March 2024 during the American Academy of Dermatology meeting. The Phase 3 ICONIC LEAD and ICONIC TOTAL trials completed enrollment, with the primary endpoint assessed over 16 weeks. Additional Phase 3 trials, ICONIC ADVANCE 1 and ICONIC ADVANCE 2, commenced in early 2024 and are expected to conclude by the first quarter of 2025. The ongoing Phase 2b ANTHEM study for ulcerative colitis is anticipated to finish by the second quarter of 2025.
Discovery Programs: Protagonist is set to announce a development candidate from its oral IL-17 discovery program by the end of 2024. The company is focused on discovering novel peptides targeting various disease areas, including hematology, inflammation, and metabolic diseases.
Financial Highlights:
- Cash Position: As of March 31, 2024, Protagonist had $322.6 million in cash, cash equivalents, and marketable securities, down from $341.6 million at the end of 2023.
- Revenue: License and collaboration revenue for Q1 2024 was reported at $255 million, primarily from the Takeda collaboration.
- Expenses: Research and development expenses increased due to higher costs associated with rusfertide's Phase 3 VERIFY trial and other research activities. General and administrative expenses also rose, primarily due to advisory and legal costs related to the Takeda agreement and increased personnel expenses.
- Net Income: The company reported a net income of $207.3 million for Q1 2024, a significant turnaround from the net loss of $33.7 million in the same period the previous year.
Protagonist Therapeutics continues its mission to develop peptide-based therapies, with rusfertide and JNJ-2113 at the forefront of its clinical development efforts.
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