Acasti Pharma Provides Business Update for the First Quarter of Fiscal 2021 - Seite 2

The Company provided all of the TRILOGY 1 background information and accompanying data to the U.S. Food and Drug Administration (FDA) in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to the Company’s Type C Meeting request and briefing package, and confirmed that pivotal efficacy analyses for TRILOGY 2 will be performed on the full Intent to Treat (ITT) population, as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes.

After reviewing feedback from the FDA and from key experts including Dr. Mozaffarian, Acasti finalized the SAP for TRILOGY 2, and submitted it to the FDA on July 31, 2020. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020.  An update on the timing for reporting the key secondary and exploratory endpoints from both the TRILOGY 1 and TRILOGY 2 trials, as well as pooled results from both studies, will be provided after TRILOGY 2 results are reported. 

Jan D’Alvise, President and CEO of Acasti, commented, “With the TRILOGY 2 SAP finalized and now submitted to the FDA, we continue to advance the process towards unblinding of our TRILOGY 2 clinical data. We believe if TRILOGY 2 can achieve statistical significance, and if the pooled efficacy results with TRILOGY 1 using the Intent to Treat population also reaches significance, we can proceed with our Pre-NDA meeting where we intend to discuss with the FDA the use of this data to support an NDA filing. We look forward to the unblinding of TRILOGY 2 data and reporting our findings, concurrent with a conference call update on or about August 31, 2020.”

As of June 30, 2020, Acasti had cash and cash equivalents totaling $12.1 million, compared to $16.0 million as of June 30, 2019. The Company believes it is sufficiently funded through the first calendar quarter of 2021, based on management’s current projections.

First Quarter of Fiscal 2021 Financial Results (US dollars):

The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).

• Loss from operations for the three months ended June 30, 2020 was $4.1 million, compared to a loss from operations of $8.0 million for the three months ended June 30, 2019. The decrease was due mainly to a reduction in research contract expenses as the Phase 3 clinical program for CaPre was nearing completion.
• Net loss for the three months ended June 30, 2020 was $4.7 million or $0.05 per share, compared to a net loss of $8.8 million or $0.11 per share for the three months ended June 30, 2019. The decreased net loss is primarily due to the reduction of research and development expenses as the Phase 3 clinical program for CaPre was nearing completion, lower net financial expenses, and the change in fair value of the warrants derivative liabilities.
• R&D expenses before depreciation, amortization and stock-based compensation expenses were $1.1 million for the three months ended June 30, 2020, compared to $5.5 million for the three months ended June 30, 2019. The net decrease was mainly attributable to a reduction in research contract expense due to the advancement of the Phase 3 clinical trial program, as it moved closer to completion.
• General and Administrative expenses before stock-based compensation expenses were $1.3 million for the three months ended June 30, 2020, an increase of $0.33 million from $0.97 million for the three months ended June 30, 2019. This increase was mainly attributable to consulting, accounting, and legal fees in connection with the conversion from IFRS to U.S. GAAP.  
• Sales and Marketing expenses before stock-based compensation expenses were $0.57 million for the three months ended June 30, 2020, compared to $0.68 million for the three months ended June 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a slowdown in pre-launch marketing activities pending the results of the TRILOGY Phase 3 clinical studies are obtained. The decrease was partially offset by an increase in salaries and benefits as a result of increased headcount in the commercial team to support expanded business and market development activities.
• Cash and cash equivalents totaled $12.1 million as of June 30, 2020, compared to $16.0 million at June 30, 2019. As stated above, Acasti believes that current cash will fully fund the Company’s operations through the first calendar quarter of 2021. Acasti projects that additional funds will be needed in the future for activities necessary to prepare for the commercial launch of CaPre if regulatory approval is received, including the scale-up of its manufacturing operations, the completion of the potential regulatory NDA submission package (assuming positive Phase 3 clinical results), and the expansion of business development and U.S. commercial launch activities. The Company is working towards development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the near future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or non-dilutive financings. If the Company does not raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company’s ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business. 

Conference Call