On May 7, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the first quarter ended March 31, 2020, and provided an update on clinical development programs (Press release, Protagonist, MAY 7, 2020, View Source [SID1234557293]).
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"Based on the highly promising and consistent clinical responses achieved to date, we are pleased to announce polycythemia vera as the first indication for a pivotal study of PTG-300," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "With an orphan drug development regulatory path forward, we are focused on rapidly advancing PTG-300 as a first-in-class non-cytoreductive hepcidin hormone mimetic agent for this indication with significant unmet need. With a highly focused development effort forward with PTG-300 for polycythemia vera, and deferring PN-943 Phase 2 initiation due to the current COVID-19 environment, we have reduced our operational expenditures and now have an additional six months of cash runway estimated to extend through mid-2022."
Product Development Update
PTG-300: Injectable Hepcidin Mimetic
Initial Phase 2 results in patients with polycythemia vera from an ongoing study demonstrated that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks controlled hematocrit levels. All patients were phlebotomy free (except a single phlebotomy due to an unintended dose interruption in a patient who remains on study). Administration of PTG-300 was well tolerated and the safety profile was generally similar with results of prior studies, with injection site reactions and bruise as the only adverse events related to or possibly related to treatment. Results are available as of the May 1, 2020, cutoff date.
The results of the PTG-300 beta-thalassemia Phase 2 study will be presented at an upcoming medical conference in the second quarter of 2020.
Protagonist will redirect the majority of its PTG-300 efforts to the polycythemia vera indication, while also continuing its exploration of PTG-300 in hereditary hemochromatosis. The Company is discontinuing clinical development for PTG-300 in beta-thalassemia and myelodysplastic syndromes.
PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease
In collaboration with Janssen Biotech, we initiated a Phase 2 global study for PTG-200 (or JNJ-67864238) in moderate-to-severe Crohn’s disease in the fourth quarter of 2019. Because of the global COVID-19 pandemic, guidance has been currently suspended on a timeline for study completion.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease
A Phase 2 study of PN-943 in approximately 150 patients with moderate-to-severe ulcerative colitis is currently planned.
In light of the global COVID-19 pandemic, Protagonist continues to review all aspects of the planned Phase 2 study and is currently suspending guidance on a timeline for study initiation. The Company is maintaining readiness to initiate the study as soon as conditions allow for safe accrual of subjects for the global study.
Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2020, were $117.5 million. Due to the focusing of efforts on polycythemia vera and the delay in PN-943 trial initiation caused by the ongoing global COVID-19 pandemic and a related internal reorganization, the company believes its adjusted operating plans now provide sufficient financial resources from its cash, cash equivalents, marketable securities and access to its debt facility to fund its currently planned operating and capital expenditures through mid-2022. The company will continue to monitor events closely and may further adjust its operating plans as warranted.
License and Collaboration Revenue: License and collaboration revenue of $3.6 million for the first quarter of 2020 increased in comparison to $1.6 million reported for the same period of 2019. License and collaboration revenue is generally earned over time as services are provided under the collaboration.
Research and Development ("R&D") Expenses: R&D expenses for the first quarter 2020 were $18.8 million as compared to $12.4 million for the same period of 2019. The increase was primarily due to increased clinical development costs related to PTG-300, PN-943 and our IL-23 receptor antagonist collaboration with Janssen Biotech to develop PTG-200 and the related research collaboration eff
General and Administrative ("G&A") Expenses: G&A expenses for the first quarter 2020 were $4.6 million, as compared to $3.8 million for the same period of 2019. The increase was primarily due to increases in salaries, employee-related expenses and professional services to support the growth in our operationsNet Loss: The first quarter 2020 net loss was $20.1 million, or a net loss of $0.72 per share, as compared to a net loss of $14.1 million, or a net loss of $0.58 per share, for the same period of 2019.
Conference Call and Webcast Information
Protagonist will host a conference call at 5 p.m. EDT / 2 p.m. PDT today to provide a corporate update. Ronald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount Sinai, will join the call to present initial results for PTG-300 in polycythemia vera. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 4597494. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.