On November 4, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update (Press release, Protagonist, NOV 4, 2020, View Source [SID1234569891]).

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"The three clinical assets PTG-300, PN-943 and PTG-200, all discovered through our peptide technology platform, continue to make progress in Phase 2 clinical proof-of-concept studies," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We look forward to sharing updated clinical data in December from our Phase 2 study of PTG-300 in patients with polycythemia vera and see significant opportunity for PTG-300 to address unmet needs and improve upon the current standards of care."

Dr. Patel continued, "We are moving forward with our ongoing Phase 2 clinical programs with the oral alpha-4-beta-7 integrin antagonist PN-943 in patients with ulcerative colitis, and the oral interleukin-23 receptor antagonist PTG-200 in patients with Crohn’s disease. In addition, we’re encouraged by the steady progress in our ongoing collaboration with Janssen, and recently announced the selection of two additional oral interleukin-23 receptor antagonists, PN-235 and PN-232, for advancement into clinical development. These candidates provide several strategic options for development in multiple indications."

Product Development and Corporate Update

PTG-300: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera and Other Blood Disorders

Five presentations have been accepted for the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual meeting, taking place in a virtual format from December 5-8, 2020. Two posters and one oral presentation are related to PTG-300 and polycythemia vera and two posters describe the hepcidin mimetic mechanism of action and a hepcidin mimetic for oral delivery.
In October, PTG-300 was granted orphan designation by the European Medicines Agency for the treatment of polycythemia vera.
Complete enrollment of 50 patients in the PTG-300 polycythemia vera study is expected in mid-2021.
A pivotal study of PTG-300 in the treatment of polycythemia vera is expected to begin in the second half of 2021 pending dialog with regulatory authorities.
An open-label proof-of-concept study of PTG-300 in patients with hereditary hemochromatosis is in progress and results are expected in 2021.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

Protagonist has dosed patients in a global, randomized, double-blind, placebo-controlled Phase 2 study (the "IDEAL Study") evaluating safety, tolerability and efficacy of PN-943 in approximately 150 patients with moderate to severe ulcerative colitis.
In light of the global COVID-19 pandemic, Protagonist has suspended guidance on a timeline for study completion.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist Collaboration)

Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (JNJ-67864238) through completion of a Phase 2 clinical proof of concept study in the treatment of Crohn’s disease.
Two additional oral peptide IL-23 receptor antagonist candidates from the collaboration agreement with Janssen Biotech, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), have been selected for advancement into clinical development. A Phase 1 study of PN-235 is expected to begin in the fourth quarter of 2020.
Financial Update

During the third quarter of 2020, the Company issued 333,000 shares through its at-the-market (ATM) program and raised $6.4 million; shares were sold at an average price of $19.65 per share.
The Company also reported sales of an additional 918,000 shares through its ATM program during October 2020, raising $18.9 million, at an average price of $21.03 per share.
Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2020, were $200.0 million. Protagonist estimates 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-2023.
License and collaboration revenues were $13.1 million and $23.0 million for the three and nine months ended September 30, 2020, respectively, in comparison to $4.1 million and $(2.5) million reported for the same periods of 2019. The increase in revenue in the third quarter of 2020 compared to 2019 was related to an estimate update for services completed versus remaining services to be performed under the Janssen collaboration agreement. This revised estimate accelerated our overall performance percentage completion under the current accounting performance obligation, coupled with continued delivery of Protagonist’s services under the ongoing collaboration. The increase in year-over-year revenue was also related to a previously reported 2019 one-time cumulative adjustment related to the application of revenue recognition principles following the May 2019 amendment of the Janssen Biotech collaboration agreement that had reduced revenue by $9.4 million for the nine months ended September 30, 2019.
Research and Development (R&D) expenses for the three and nine months ended September 30, 2020, were $16.0 million and $55.0 million, respectively, as compared to $17.3 million and $49.1 million for the same periods of 2019. 2020 expenses were primarily related to advancing our clinical development including the ongoing Phase 2 clinical trial for polycythemia vera with PTG-300, PN-943 Phase 2 study in ulcerative colitis, and the IL-23 receptor antagonist research collaboration activities with Janssen Biotech.
General and Administrative (G&A) expenses for the three and nine months ended September 30, 2020, were $4.9 million and $13.6 million, respectively, as compared to $4.0 million and $11.6 million for the same periods of 2019. The increases were primarily related to professional fees, insurance costs and salary related expenses to support the growth in operations.
Net loss for the three and nine months ended September 30, 2020, was $7.8 million and $47.3 million or a net loss of $0.21 per share and $1.45 per share, respectively, as compared to a net loss of $16.4 million and $59.7 million, or a net loss of $0.61 per share and $2.36 per share, respectively, for the same periods of 2019.