On November 2, 2023 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Protagonist, NOV 2, 2023, View Source [SID1234636785]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the third quarter of 2023, Protagonist continued to make rapid progress with its key programs," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "Positive Phase 2b data from the FRONTIER 1 study with JNJ-2113, established it as a first- and only-in-class oral IL-23 receptor antagonist peptide and triggered the decision to progress into several advanced studies for broad clinical development. In October 2023, Janssen initiated two Phase 3 psoriasis studies, and a Phase 2b ulcerative colitis study, and plans to undertake additional Phase 3 psoriasis studies in the first quarter of next year. The extraordinary pace of progress in multiple indications reflects strong confidence in JNJ-2113’s potential to have a meaningful impact on these and other diseases mediated by the IL-23 pathway."
Dr. Patel continued: "We are equally excited about the potential of rusfertide, currently in the Phase 3 VERIFY study, to transform the treatment paradigm for polycythemia vera. We are very pleased with the continuing level of enthusiasm among PV-treating physicians and patients participating in the ongoing Phase 3 VERIFY study and look forward to sharing our latest findings in Polycythemia Vera and from our ongoing studies through five oral and poster presentations at the upcoming ASH (Free ASH Whitepaper)2023 Annual Meeting."
1 Based on $322.7 million in cash, cash equivalents and marketable securities as of September 30, 2023 and including expected $60.0 million in JNJ-2113 milestones.
Q3 and Recent Corporate Highlights
· Positive Phase 2b FRONTIER 1 topline results were presented at the World Congress of Dermatology in Singapore in July 2023. All primary and secondary efficacy endpoints were achieved in the study, which evaluated five different dosing regimens of JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis. JNJ-2113 is a novel oral IL-23R antagonist peptide which binds with high affinity to the IL-23 receptor.
· Following positive data from the FRONTIER 1 study, advanced clinical studies in multiple indications were announced and recently initiated:
§ ICONIC-LEAD is a randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113 compared with placebo in participants with moderate-to-severe plaque psoriasis, with PASI-90 and IGA score of 0 or 1 as co-primary endpoints.
§ ICONIC-TOTAL is a randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113 compared with placebo for the treatment of plaque psoriasis in participants with at least moderate severity affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet) with overall IGA score of 0 or 1 as the primary end point.
§ ANTHEM-UC is a Phase 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in patients with moderately to severely active ulcerative colitis.
· Dosing of the third patient in the ICONIC-LEAD Phase 3 trial in late October 2023 earned Protagonist a $50 million milestone from Janssen Biotech, Inc. under the terms of the licensing and collaboration agreement between both companies.
· Five abstracts related to rusfertide, an investigational hepcidin mimetic, were accepted for oral or poster presentation at ASH (Free ASH Whitepaper)2023, as follows:
Oral presentations
§ Title: Real-World Analysis of Thromboembolic Event Rates in Patients in the United States with Polycythemia Vera. Presenting author: Andrew T. Kuykendall, MD (Moffitt Cancer Center, Tampa, FL).
§ Title: Durability of Hematocrit Control in Polycythemia Vera with the First-in-Class Hepcidin Mimetic Rusfertide: Two-Year Follow up Results from the Revive Study. Presenting author: Ellen K. Ritchie, MD (Weill Cornell Medical College New York Presbyterian, NY).
Poster presentations
§ Title: Iron Restricted Erythropoiesis Under Hepcidin Mimetic Treatment (PN23114) Improved Disease Parameters in a Mouse Model for Sickle Cell Disease. Presenting author: Roopa Taranath, PhD (Protagonist Therapeutics, Inc., Newark, CA).
§ Title: Rusfertide Improves Markers of Iron Deficiency in Patients with Polycythemia Vera. Presenting author: Yelena Ginzburg, MD (Mount Sinai, New York, NY).
§ Title: Prevalence of Second Cancers in Patients with Polycythemia Vera (PV): A Retrospective Analysis of US Real-World Claims Data. Presenting author: Naveen Pemmaraju, MD (MD Anderson Cancer Center, Houston, TX).
At the 5th International Congress on Myeloproliferative Neoplasms, held November 2-3, 2023, Dr. Naveen Pemmaraju presented a poster titled, "Summary of Malignancies Observed Across 5 Open Label Clinical Trials of the Hepcidin Mimetic Rusfertide." The poster can be found on the Protagonist corporate website at View Source
Third Quarter 2023 Financial Results
· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2023, were $322.7 million.
· License and Collaboration Revenue: License and collaboration revenue was zero for the three and nine months ended September 30, 2023, as we completed our performance obligation associated with the Janssen License and Collaboration Agreement as of June 30, 2022. License and collaboration revenue for the three and nine months ended September 30, 2022, was zero and $26.6 million, respectively. The nine months ended September 30, 2022, included a one-time $25.0 million milestone earned by the Company following the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 clinical trial of JNJ-2113.
· Research and Development ("R&D") Expenses: R&D expenses were $30.7 million and $91.3 million for the three and nine months ended September 30, 2023, respectively, as compared to $25.4 million and $96.3 million for the same periods in 2022. The increase in R&D expenses from the prior year quarter was primarily due to an increase in rusfertide expenses related to the Phase 3 VERIFY clinical trial, partially offset by a decrease in PN-943 expenses. The decrease in R&D expenses from the prior year was primarily due to decreases in PN-943 expenses and costs related to preclinical and discovery research, partially offset by an increase in rusfertide expenses.
· General and Administrative ("G&A") Expenses: G&A expenses were $7.7 million and $25.4 million for the three and nine months ended September 30, 2023, respectively, as compared to $6.9 million and $25.1 million for the same periods in 2022. The increase in G&A expenses from the prior year quarter was primarily due to increases in payroll, stock-based compensation, and general expenses.
· Net Loss: Net loss was $34.1 million, or $0.58 per share, for the three months ended September 30, 2023, as compared to a net loss of $31.2 million, or $0.64 per share, for the three months ended September 30, 2022. Net loss was $106.3 million, or $1.91 per share, for the nine months ended September 30, 2023, as compared to a net loss of $93.2 million, or $1.90 per share, for the nine months ended September 30, 2022.