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SEC Filings

8-K
PROTAGONIST THERAPEUTICS, INC filed this Form 8-K on 03/07/2017
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    Initiated a global Phase 2b trial for PTG-100 with the goal of enrolling a total of approximately 240 ulcerative patients with moderate to severe active disease. An interim futility analysis is expected to be performed in the second half of 2017. If the outcome is not futile, one or two optimal doses of PTG-100 will be selected for continued randomization of the remaining patients. Top-line results are expected in second half of 2018.

Financial Results

Protagonist reported a net loss of approximately $37.2 million for the full year 2016, as compared to a net loss of $14.9 million for the prior year. The company reported a net loss of $11.2 million for the fourth quarter of 2016, as compared to a net loss of $5.5 million for the fourth quarter of 2015. The increase in net loss was driven primarily by research and development expenses related to PTG-100 clinical trials and other pre-clinical product candidate studies, and general and administrative expenses for operations.

Research and development expenses for the full year 2016 were $25.7 million, as compared to $11.8 million for the prior year. Research and development expenses for the fourth quarter of 2016 were $8.8 million, as compared to $4.2 million for the same period in the prior year. Research and development expenses for the fourth quarter included costs related to contract manufacturing, the preparation for and conduct of PTG-100 clinical trials, and preclinical development studies for other product candidates. The expense increases for the fourth quarter were partially offset by an increase of $2.4 million from our claim under the Australian research and development tax incentive program that includes the recognition of reimbursements of amounts related to non-Australian expenses. Funding under this tax incentive program was completed in 2016, and we expect to receive final payment of $2.2 million in 2017.

General and administrative expenses for the full year 2016 were $7.0 million, as compared to $3.0 million for the prior year. General and administrative expenses for the fourth quarter of 2016 were $2.6 million, as compared to $0.8 million for the same period in the prior year. The increase in G&A expense in these periods was due primarily to an increase in professional service fees, salaries and employee-related expense primarily due to an increase in headcount to support the growth of our operations, and other administrative expenses.

Protagonist ended the third quarter of 2016 with $98.5 million in cash, cash equivalents and investments and ended the fourth quarter of 2016 with $87.7 million in cash, cash equivalents and investments. The company expects current capital resources will be sufficient to fund operations through PTG-100 Phase 2b top-line data which is expected in the second half of 2018.