On May 4, 2021 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or the "Company") reported financial results for the first quarter of 2021 ended March 31, 2021 and provided a corporate update (Press release, Protagonist, MAY 4, 2021, View Source [SID1234579132]).
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"Our progress this quarter affirms the strength of our pipeline and execution capabilities," said Dinesh Patel, PhD, Protagonist’s President and Chief Executive Officer. "For our lead drug candidate, rusfertide in polycythemia vera, we have completed enrollment for our Phase 2 study and confirmed the registrational path forward based on recent engagement with both U.S. and European regulators. We look forward to providing an interim update from our ongoing Phase 2 study at a major medical conference in the second quarter of 2021."
Dr. Patel continued, "We are very pleased with the rate of enrollment in our ongoing Phase 2 study of the oral alpha-4-beta-7-integrin antagonist PN-943. For our oral IL-23 receptor antagonists, we expect to dose the first subject in the Phase 1 study of PN-232 in the second quarter of 2021 and intend to complete both this trial and the Phase 1 trial of PN-235 during the second half of 2021. There is excellent movement forward across our full portfolio, driven by our commitment to patients in need of new and better therapeutic options."
PRODUCT DEVELOPMENT AND CORPORATE UPDATE
Disorders of Red Blood Cells and Iron Regulation
Rusfertide (PTG-300)
Investigational, injectable, hepcidin mimetic discovered through our peptide technology platform. Hepcidin is a natural hormone that regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Rusfertide is currently being evaluated for disorders associated with iron overload and excessive erythrocytosis (red blood cell production).
In March 2021, following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") and written comments from the European Medicines Agency ("EMA"), Protagonist has advanced its preparations for a global pivotal study of rusfertide in polycythemia vera ("PV"). The Company plans to initiate this Phase 3 study in early 2022.
In April 2021, Protagonist announced completion of enrollment in the ongoing Phase 2 study of rusfertide in PV. The Company plans to present updated interim data from this study at an upcoming medical meeting in the second quarter of 2021.
In the second half of 2021, Protagonist expects to announce preliminary results from the ongoing Phase 2 open-label proof-of-concept study of rusfertide in patients with hereditary hemochromatosis ("HH").
In addition to ongoing studies in PV and HH, the Company expects to select a third indication for rusfertide in 2021.
Inflammatory Bowel Diseases
PN-943
Investigational, orally delivered, gut-restricted alpha-4-beta-7 specific integrin antagonist for inflammatory bowel diseases.
The 150-patient Phase 2 "IDEAL" study evaluating the safety, tolerability and efficacy of PN-943 in patients with moderate to severe ulcerative colitis is underway, and the study is on track for completion in 2022.
Oral IL-23 Receptor Antagonists
PTG-200; PN-235; PN-232 (Janssen collaboration)
Investigational, orally delivered, IL-23 receptor antagonists. Protagonist has entered into a worldwide agreement with Janssen to co-develop and commercialize these drug candidates.
In the second quarter of 2021, Protagonist expects to dose the first subject in the Phase 1 study of PN-232. The Company expects to complete both this trial and the Phase 1 trial of PN-235 in the second half of 2021. PN-232 and PN-235 are part of the oral IL-23 pathway blocker portfolio strategy, pursued in collaboration with Janssen.
Enrollment continues for the Phase 2a proof-of-concept PRISM study of PTG-200, a first-generation drug candidate for patients with moderate to severe Crohn’s disease.
First Quarter 2021 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2021 were $279.7 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the first half of 2024.
License and Collaboration Revenue: License and collaboration revenue was $6.2 million for the first quarter of 2021 compared to $3.6 million for the same period of 2020. The increase was primarily due to the additional services provided to Janssen under the collaboration agreement during 2021 related to PN-232 and PN-235.
Research and Development ("R&D") Expenses: R&D expenses for the first quarter 2021 were $24.2 million as compared to $18.8 million for the same period of 2020. The increase was primarily due to costs associated with advancing our clinical trials with our pipeline assets of rusfertide and PN-943, as well as our three IL-23 receptor antagonist assets under the Janssen collaboration (PTG-200, PN-235 and PN-232).
General and Administrative ("G&A") Expenses: G&A expenses for the first quarter 2021 were $6.0 million as compared to $4.6 million for the same periods of 2020. The increase was primarily related to professional fees and employee compensation related expenses supporting the growth in our operations.
Net Loss: The first quarter net loss was $24.0 million, or a net loss of $0.54 per share, compared to the first quarter of 2020 net loss of $20.1 million, or a net loss of $0.72 per share.