After U.S. markets closed for trading yesterday, Protagonist Therapeutics Inc. (PTGX:NASDAQ) reported financial results for Q1/20 ending March 31, 2020, and also provided an update on clinical development programs.
The company's President and CEO Dinesh V. Patel, Ph.D., commented, "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...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."
The company provided an update on the status of its three main pipeline drug candidates. These candidates include PTG-300, which is currently being studied in a Phase 2 trial study for use in polycythemia vera; PTG-200 that is part of a Phase 2 global study in moderate-to-severe Crohn's disease, which has been temporarily suspended due to the COVID-19 situation; and PN-943, which the company plans to test in a Phase 2 study in approximately 150 patients with moderate-to-severe ulcerative colitis.
The company stated that as of March 31, 2020, it had cash and cash equivalents on hand totaling $117.5 million. It reported that it earned license and collaboration revenue in Q1/20 of $3.6 million, compared to $1.6 million in Q1/19.
The firm stated that research and development expenses for Q1/20 were $18.8 million, versus $12.4 million in Q1/19 and noted that the increase was due primarily to increased collaborative clinical development costs.
The company posted a net loss of $20.1 million, or ($0.72) per share in Q1/20, compared to a net loss of $14.1 million, or ($0.58) per share in Q1/19.
In a separate news release, Protagonist Therapeutics announced initial data from its ongoing Phase 2 study of PTG-300 in patients with polycythemia vera. The company stated that "the current results demonstrate that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks provided dose-related control of hematocrit levels and eliminated the need for phlebotomy in all six out of six patients that received the dosing as per protocol...and in addition, positive symptomatic measurements related to the ability of PTG-300 to address iron deficiency in these frequently phlebotomized patients were observed, with increases in serum ferritin values approaching the range observed in healthy subjects."
The company's Chief Medical Officer Samuel Saks, M.D., commented, "While further follow up and data from additional patients will be needed to confirm the continuity of the robust clinical responses observed to date, we believe that this study provides a compelling rationale to initiate planning for a pivotal program in polycythemia vera...As a peptide mimetic of the natural hepcidin hormone, PTG-300 is believed to limit the excess number of red blood cells in polycythemia vera by reducing iron available for red blood cell production."
Ronald Hoffman, M.D., director of the Myeloproliferative Diseases Program at the Icahn School of Medicine at Mount Sinai and an investigator in the PTG-300 polycythemia vera study, remarked, "These initial data demonstrate the potential of PTG-300 to almost entirely avoid the need for phlebotomy in the treatment of polycythemia vera by persistent control of hematocrit levels to below 45 percent...PTG-300 offers the possibility of maintaining patients consistently below 45 percent hematocrit levels with weekly administration of a mimetic of the endogenous iron regulator without the up and down excursions inherent in typical phlebotomy therapy....These early results are very encouraging and suggest the potential for a paradigm shift for the treatment of polycythemia vera."
The company advised that the study is designed to monitor the safety profile and to obtain evidence of efficacy in patients requiring frequent phlebotomies. The firm has enrolled eight patients in the continuing study and is looking to increase the number to 50 patients. The company reported that administration of PTG-300 has been well tolerated in the study.
Protagonist Therapeutics, headquartered in Newark, Calif., describes its business as "a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs." The company's drug candidate pipeline includes PTG-300 used in the treatment of iron overload anemia and related rare blood diseases including beta-thalassemia and polycythemia vera.
Protagonist Therapeutics began the day with a market capitalization of around $212.1 million with approximately 27.44 million shares outstanding and a short interest of about 4.7%. PTGX shares opened 27% higher today at $9.84 (+$2.11, +27.30%) over yesterday's $7.73 closing price and then climbed to a new 52-week high price this morning of $16.82. The stock has traded today between $9.65 and $16.82 per share and is currently trading at $15.32 (+$7.59, +98.19%).[NLINSERT]
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