Acasti Pharma Inc. (NASDAQ: ACST) is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one-third of the U.S. population.
On August 14, 2018, the company’s shares were trading at $.45 per share. Since then the ACST shares have hit a high of $1.80 before settling at today’s level of $1.19.
On October 4th, 2018, the company announced that, in connection with its overnight marketed public offering previously announced on October 3, 2018, it has entered into an underwriting agreement with Mackie Research Capital Corporation to sell 18,750,000 Class A Shares at a price of C$1.28 per Common Share, for aggregate gross proceeds to Acasti of C$24,000,000.
On October 4, 2018, the Company also priced a separate and concurrent underwritten public offering of Common Shares in the United States (the “U.S. Offering”) at a price of US$1.00 for total gross proceeds of US$16,600,000.
Acasti’s TRILOGY Phase 3 clinical studies for its product candidate CaPre® (omega-3 phospholipid) are currently underway and will be conducted at approximately 140 sites across North America and as per management, the net proceeds received by the Company from the Offering, together with cash on hand and the U.S. Offering, are intended to be used by the Company for the further development of CaPre and to complete the Company’s Phase 3 program through to top-line results, including completion of clinical site activation, patient enrolment and randomization, and production of clinical materials (both CaPre and placebo) for the Company’s Phase 3 program; planning and initiation of the Company’s regulatory (NDA) submission; expansion of business development activities; working capital; and other general corporate purposes.
Before that on August 14th, the company announced its operating and financial results for the first quarter ending June 30, 2018. The company confirmed that its two TRILOGY Phase 3 studies remain on track to complete enrollment this year. Importantly, as of August 10, 2018 ACST reached almost 60% enrollment, with 770 patients enrolled, and 110 patients randomized at 126 clinical sites across the U.S., Canada, and Mexico. ACST continue to project that it will complete these studies on schedule in mid-2019 and expect to report top-line results before the end of 2019.
CaPre Development Timeline and Key Milestones:
Analysts tracking the stock believes that the addressable market for the company may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti might need to conduct at least one additional clinical trial to support FDA approval of a supplemental New Drug Application to expand CaPre’s indications to this segment. With the upcoming milestones in its pipeline, a strengthened cash position, and expected development and distribution partnerships to market CaPre in major countries, Acasti is well poised for substantial growth for the foreseeable future.
As per www.marketbeat.com, average twelve-month price target is $7.00, suggesting that the stock has a possible upside of 422.39%. The high price target for ACST is $7.00, and the low-price target for ACST is $7.00. There are currently two buy ratings for the stock, resulting in a consensus rating of “Buy.”
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Below are the excerpts of recent analyst rating/Price targets on the company:
About the company:
Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one-third of the U.S. population. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. The company is developing CaPre in Phase 3 clinical program in patients with severe hypertriglyceridemia, a market that includes 3 to 4 million patients in the U.S. The company was incorporated in 2002 and is headquartered in Laval, Canada.
About Trilogy: TRILOGY, an acronym derived from “Phase 3 Studies of CaPre in Lowering Very High Triglycerides,” is a double-blind, placebo-controlled, 26-week, two-trial Phase 3 clinical program designed to evaluate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia. TRILOGY 1 and TRILOGY 2 is running in parallel and will randomize a total of approximately 500 patients. The program is being conducted at approximately 150 sites across the U.S., Canada, and Mexico.
Key and Unique differentiating factor of the company:
First Quarter 2019 Financial Results:
ACST has a fiscal year end of March 31st.
- Net loss for the first quarter ended June 30, 2018, was $7.4 million or $0.23 per share, compared to a net loss of $2.8 million or $0.19 per share for the quarter ended June 30, 2017. The higher net loss was primarily due to the planned increase in research and development expenses (“R&D”) for the TRILOGY Phase 3 program.
- Cash flows – Cash and cash equivalents totaled $12.9 million as of June 30, 2018 and increased with $11.5 million in gross proceeds from the May 2018 underwritten public offering in Canada with the full exercise of the overallotment option. As previously disclosed, there exists a material uncertainty about the company’s ability to continue as a going concern and to realize its assets and discharge its liabilities in the normal course of business. Management has a reasonable expectation that the company should be able to raise additional funds later in 2018 to continue to finance the TRILOGY Phase 3 program for CaPre.
Key risk factors and potential stock drivers:
- Any adversities related to the future guidance might adversely impact the overall investor sentiments.
- Any time/cost overruns and or suspensions or delays in the completion of clinical testing could result in increased costs and delay or prevent its or certain of its subsidiaries’ ability to complete development of that product or generate product revenues.
- Extensive industry regulation has had and will continue to have, an impact on ACST’ business in the area of cost of goods, especially its product development, manufacturing, and distribution capabilities.
- On Tuesday, October 9th, 2018, ACST was at $1.19, on traded volume of 628K shares exchanging hands. Market capitalization is $87.772 million. The current RSI is at 59.62
- In the past 52 weeks, shares of ACST shave traded as low as $0.43 and as high as $3.36
- At $1.19, shares of ACST are trading above its 50-day moving average (MA) at $0.69 and above its 200-day moving average (MA) at $0.82
- The present support and resistance levels for the stock are at $1.15 & $1.35 respectively.
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