The company had a strong start to 2016. During the quarterly earnings call management provided an update on the Phase 2b SPIRITUS trial. We had initially estimated the study to complete by Q2 2016. However as mild temperatures prevailed longer than usual, the cold season arrived late in 2015 in the U.S. Consequently, patient enrollment has been slower than planned for the multicenter trial. Despite the slight slip in recruitment timelines, management hopes to complete enrollment and release top-line results in 2H 2016. With the trial data expected late this year, we think a successful outcome of the trial might be a huge driver for collaborating with potential partnership for drug development. We think management may decide to pursue this intent to collaborate aggressively once data becomes available later this year.
The company successfully completed the RSV fusion inhibitor, BTA585 Phase 1 single ascending dose (SAD) study. The results showed a favorable safety and pharmacokinetic (PK) profile. Following the successful SAD study, Biota commenced the Phase 1 multiple ascending dose (MAD) study that is now completed. The safety and PK results are expected before end of this quarter (Q3 2016). The company hopes to achieve successful safety and tolerability results with minimal adverse events. This trial will also help management in deciding dose levels so they can initiate the Phase 2a RSV challenge study in Q3 2016. The topline data from this Phase 2 trial is expected during 2H 2016.
As anticipated, BOTA has commenced screening patients for the Phase 2 double-blind, randomized, placebo-controlled trial of BTA074, the direct-acting antiviral for the treatment of condyloma caused by HPV types 6 & 11. The primary objective of this study is to assess the safety, tolerability, PK, and efficacy of the compound. Approximately 210 adult condyloma patients will be treated with topical applications of BTA074 (5% gel) twice daily for up to 16 weeks. Management announced today (Feb 8, 2016) that the first patient has been dosed in this Phase 2 trial. We expect top line data from this trial to be available in 1H 2017.
Q2 2016 Financial Results:
In 2014, the company received large stockpile orders for Relenza as the cold season arrived earlier than usual. Therefore, the revenue for Q2 2015 was higher (~$14M) than that of Q2 2016. Additionally, this year, due to the delay in cold season, royalty revenues as well as seasonal sales of Relenza and Inavir were lower. Additionally, the company lost $7.4M in revenue from conclusion of the BARDA contract. Therefore, the company reported revenue of only $1.7M for Q2 2016.
The clinical costs related to the ongoing Phase 2b SPIRITUS trial involving vapendavir, the Phase 1 SAD and MAD trials for BTA585, and the expenses related to the Phase 2 trial concerning BTA074 amounted to $6.3M for Q2 2016. Biota has consistently shown progress in their clinical development pipeline. As the trials are ongoing, we expected R&D expenditures to show a slight upward trend in the coming quarters. Management gave guidance on the earnings call (Feb 5, 2016) that R&D expenses will continue to grow as they ramp-up progress on these trials.
General and administrative costs came in at $2.1M. Biota reported a net loss of $6.5 million that equates to an EPS of -$0.17/share. The company exited the quarter with a cash balance (cash, cash equivalents, and short and long-term investments) of $57.2M.
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