On May 9, 2018 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported its financial results for the first quarter ended March 31, 2018 (Press release, Protagonist, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348218 [SID1234526387]).

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"Protagonist is continuing to build a broad and diverse pipeline of potentially transformative drug candidates discovered through its innovative peptide technology platform," said Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "PTG-200, the IL-23 receptor antagonist being developed in collaboration with Janssen Biotech, Inc., is currently in a Phase 1 study, and we expect a U.S. IND filing by the end of 2018 to support a Phase 2 global study in Crohn’s disease. With our hepcidin mimetic PTG-300, we plan to commence a Phase 2 study in beta-thalassemia patients in the fourth quarter of 2018."

"In addition to developing PTG-200 and PTG-300, we are conducting a comprehensive review of the PTG-100 dataset from the Phase 2b PROPEL study and expect to report our findings in the third quarter of 2018. As previously announced, we discontinued the trial based on a planned interim analysis by an independent Data Monitoring Committee and noted that it also showed an unexpectedly high placebo response rate," continued Dr. Patel.

Product Development Update:

PTG-100

A planned interim analysis was conducted during the first quarter for the Phase 2b PROPEL study of PTG-100, the company’s investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis. The Data Monitoring Committee reported that the interim analysis met prespecified futility criteria on the primary endpoint of clinical remission, and as a result the study was discontinued. It was also noted that the study experienced an unusually high placebo response rate.
Protagonist is now conducting an extensive review of the complete dataset from all patients enrolled in the Phase 2b trial. The Company will determine next steps for PTG-100 and for the general therapeutic approach of oral, GI-restricted alpha-4-beta-7-integrin antagonists after completing this review which is expected to be in the third quarter of 2018.
PTG-200

Dosing has been completed for all cohorts in the Phase 1 study of PTG-200, a first-in-class oral, GI restricted, IL-23 receptor antagonist peptide, which is partnered with Janssen Biotech, Inc. (Janssen). The Phase 1 study in normal healthy volunteers was initiated in Australia in November 2017 and involves single-ascending doses and multiple ascending doses of PTG-200.
In the second half of 2018 we expect a U.S. IND filing and other regulatory filings for a global Phase 2 study of PTG-200 in Crohn’s disease to be conducted in collaboration with Janssen.
PTG-300

PTG-300, an injectable hepcidin mimetic, is in development for the potential treatment of anemia and iron overload related to rare blood disorders. We have completed discussions with U.S. and global regulatory agencies, and the Company plans to file a U.S. IND and other regulatory filings in the third quarter of 2018 with the intent to commence a global Phase 2 trial in Q4 2018 in patients with beta-thalassemia. Furthermore, treatment of anemia and transfusion-dependence in myelodysplastic syndromes and exaggerated erythropoiesis in polycythemia vera represent additional opportunities for further development of PTG-300.
The U.S. Food and Drug Administration granted Orphan Drug Designation to PTG-300 for the treatment of beta-thalassemia in March of 2018.
Preclinical programs

The Company’s oral peptide agonist targeting the mu/delta opioid receptors will be discussed in a podium presentation at the Digestive Diseases Week conference, on Saturday, June 2, from 5:00 PM to 5:15 PM ET at the Walter E. Washington Convention Center, Room 140 in Washington, D.C.
The company will present preclinical data supporting the superiority of mu/delta dual agonist activities when compared to eluxadoline in treating diarrhea or abdominal pain.
Financial Results

Protagonist reported a net loss of $7.7 million for the first quarter of 2018, as compared to a net loss of $14.1 million for the same period of 2017. The decrease in net loss was driven primarily by license and collaboration revenue recognized during the first quarter of 2018, which partially offset increased research and development (R&D) expenses and increased general and administrative (G&A) expenses. The net loss for the first quarter of 2018 includes non-cash stock-based compensation of $1.2 million, as compared to $0.8 million for the same period of 2017.

License and collaboration revenue was $10.8 million for the first quarter of 2018 and consisted of revenue from activities performed under the Janssen Collaboration Agreement. Protagonist did not recognize any license and collaboration revenue for the first quarter of 2017.

R&D expenses for the first quarter of 2018 were $15.4 million, as compared to $11.3 million for the same period of the prior year. The increase in R&D expenses was primarily due to costs related to contract manufacturing, and the preparation for and conduct of PTG-100, PTG-200 and PTG-300 clinical trials. R&D expenses for the quarter also included an increase in salaries and employee-related expenses due to an increase in R&D personnel.

G&A expenses for the first quarter of 2018 were $3.6 million, as compared to $3.0 million for the same period in the prior year. The increase in G&A expense was due primarily to increases in salaries and employee-related expenses primarily due to an increase in headcount to support the growth of our operations, franchise and business related taxes and other administrative expenses.

Protagonist ended the first quarter of 2018 with $140.5 million in cash, cash equivalents and investments. The company expects current capital resources to be sufficient to fund its operations through 2019.