On March 7, 2018 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported its financial results for the fourth quarter and full year ended December 31, 2017 and provided an update on the company’s recent achievements (Press release, Protagonist, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336855 [SID1234524514]).
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Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)
"2017 was a very successful year for Protagonist wherein we strengthened both our R&D pipeline as well as our financial position," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "During the year, we entered into a major collaboration with Janssen Biotech Inc., raised a net $64.5 million in a public offering, and ended the year with three products in different stages of clinical development."
"We believe that the company is well positioned for success in 2018," continued Dr. Patel. "We anticipate reporting the interim futility analysis outcome in the first quarter and final top-line results in the fourth quarter from our Phase 2b PROPEL trial of the oral peptide PTG-100. These results, if positive, would demonstrate the potential utility of PTG-100 as an oral targeted therapy for moderate-to-severe ulcerative colitis. During 2018, we also plan to report Phase 1 results from the Janssen collaboration asset PTG-200. Finally, we plan to commence a global clinical trial of PTG-300 in patients with beta-thalassemia and initiate IND enabling studies with our fourth asset PTG-400."
"We ended the year with approximately $155.5 million in cash, cash equivalents, and investments and anticipate having enough funds to support our operations through 2019," Dr. Patel concluded.
2017 Research and Development Highlights:
PTG-100
Protagonist initiated a global Phase 2b trial of alpha-4-beta-7 integrin oral peptide antagonist PTG-100 in approximately 240 patients with moderate-to-severe active ulcerative colitis. An interim futility analysis will be performed in the first quarter of 2018, and final top-line results are anticipated in the fourth quarter of 2018.
The company plans to initiate a Phase 2/3 clinical trial in chronic pouchitis, a rare disease indication, in 2018 pending a positive decision from the interim futility analysis in the ulcerative colitis PROPEL study.
PTG-200
Protagonist entered into a license and collaboration agreement with Janssen Biotech, Inc., a Johnson and Johnson company, to support the clinical development and potential commercialization of PTG-200, a first-in-class oral peptide interleukin-23 receptor (IL-23R) antagonist. Under the terms of the agreement, Protagonist granted Janssen an exclusive worldwide license to PTG-200 and received a $50 million upfront payment in the third quarter of 2017. Protagonist can also receive up to an additional $940 million in payments, including potential license option payments of $125 million at the Phase 2 interim analysis and $200 million at Phase 2 completion, and $615 million in other potential clinical development, regulatory approval, and sales milestones.
Protagonist and Janssen will co-develop and co-fund PTG-200 through Phase 2 clinical development. Janssen will be responsible for funding Phase 3 studies in Crohn’s disease and ulcerative colitis. Protagonist will receive double-digit tiered royalties on future net sales and retains the option to co-detail PTG-200 in the United States.
Protagonist initiated a first-in-human trial of PTG-200 in November 2017. The Phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple dose-escalation trial in normal healthy volunteers. Protagonist and Janssen collaboratively plan to complete this Phase 1 study and anticipate filing a U.S. IND and initiating a global Phase 2 study in Crohn’s disease in the second half of 2018.
PTG-300
Protagonist successfully initiated and completed a Phase 1 randomized, double-blind, placebo-controlled, single dose-escalation and repeat dose study of its hepcidin mimetic PTG-300 in normal healthy volunteers. PTG-300 was found in this study to be safe and well-tolerated at all dose levels. Moreover, in this study, PTG-300 demonstrated its intended dose-related pharmacological effect on serum iron levels, establishing pharmacodynamic clinical proof-of-concept in healthy volunteers. Following our upcoming meetings with the U.S. and European regulatory agencies, the company plans to initiate a global clinical trial of PTG-300 in beta-thalassemia in the second half of 2018.
On March 6, 2018, Protagonist announced that the U.S. Food Administration had granted Orphan Drug Designation to PTG-300 for the treatment of beta-thalassemia.
Corporate Highlights:
Protagonist completed a public offering of 3,530,000 shares of its common stock at a price to the public of $17.00 per share in October 2017. The underwriters exercised their option to purchase an additional 529,500 shares at the public offering price in November 2017. Net proceeds from the offering were approximately $64.5 million.
The company appointed two new members to the Protagonist Board of Directors during 2017: Rusty Williams, M.D., Ph.D., current Executive Chairman and former President and Chief Executive Officer of Five Prime Therapeutics, and Sarah Noonberg, M.D., Ph.D., previously Chief Medical Officer of Prothena Corporation.
Other Highlights
Protagonist was awarded a Phase 2 Small Business Innovation Research Grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health in May 2017. This grant provides up to $1.3 million of funding over two years to support the development of biomarkers useful in the clinical development of IL-23R antagonist agents for the treatment of inflammatory bowel disease (IBD), including PTG-200.
Several key patents issued to Protagonist during 2017 and January 2018 covering the company’s peptide assets. These included U.S. patents No. 9,518,091, covering the company’s alpha-4-beta-7 integrin peptide inhibitors, including PTG-100, and No. 9,809,623, providing further specific protection for PTG-100; U.S. patents No. 9,624,268, providing composition of matter protection for PTG-200 and covering the use of oral peptide inhibitors of IL-23R to treat IBD; and No. 9,822,157, covering peptide mimetics of hepcidin, including PTG-300, and related pharmaceutical compositions.
Financial Results
Protagonist reported a net loss of $37.0 million for the full year 2017, as compared to a net loss of $37.2 million for the prior year. The company reported a net loss of $3.1 million for the fourth quarter of 2017, as compared to a net loss of $11.2 million for the fourth quarter of 2016. The decrease in net loss was driven primarily by license and collaboration revenue recognized during the last half of 2017, which partially offset increased research and development expenses related to PTG-100, PTG-200, and PTG-300 clinical trials and other pre-clinical product candidate studies, and increased general and administrative expenses.
License and collaboration revenue was $20.1 million for the full year 2017 and $11.3 million for the fourth quarter of 2017 and consisted of revenue from activities performed under the agreement with Janssen. Protagonist did not recognize any license and collaboration revenue prior to the third quarter of 2017.
Research and development expenses for the full year 2017 were $46.2 million, as compared to $25.7 million for the prior year. Research and development expenses for the fourth quarter of 2017 were $11.7 million, as compared to $8.8 million for the same period in the prior year. The increase in research and development expense in these periods was due primarily to costs related to contract manufacturing, the preparation for and conduct of PTG-100, PTG-200, and PTG-300 clinical trials, and preclinical development studies for other product candidates.
General and administrative expenses for the full year 2017 were $11.8 million, as compared to $7.0 million for the prior year. General and administrative expenses for the fourth quarter of 2017 were $3.1 million, as compared to $2.6 million for the same period in the prior year. The increase in G&A expense in these periods was due primarily to increases in employee-related expenses, professional service fees, and other administrative expenses to support the growth of our headcount and operations.
Protagonist ended 2017 with $155.5 million in cash, cash equivalents and investments.
Conference Call and Web Cast Information
Protagonist executives will host a conference call at 1:30 p.m. PT/4:30 p.m. ET today. 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 4054387. The call will also be webcast and will be accessible from "Events & Presentations" in the Investors section of the company’s website at www.protagonist-inc.com. A replay will be available on the company’s website approximately two hours after the call and will remain available for 90 days.