Welcome!

News Feed Item

Acasti Pharma Reports Third Quarter 2017 Financial Results

Key Developments Include Advancement of Drug Candidate CaPre and New CFO

LAVAL, QUEBEC -- (Marketwired) -- 01/12/17 -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ: ACST)(TSX VENTURE: ACST) today announced its operating and financial results for the third quarter of its 2017 fiscal year, which ended November 30, 2016. All amounts are in Canadian dollars.

"A highlight of Acasti's third quarter was the reporting of positive data from our Phase 2 Bridging Study for CaPre®, which gives us confidence that we'll proceed with the U.S. Food and Drug Administration's (FDA) more expedited 505(b)(2) pathway, pending the outcome of our end of Phase 2 meeting with the agency," said Jan D'Alvise, president and CEO of Acasti Pharma. "More recently, we secured a Q1 date for the end of Phase 2 meeting with the FDA, and completed the first engineering production run of CaPre, both important milestones in our CaPre development program. We also welcomed Linda O'Keefe as our new CFO, augmenting our executive team that is focused on advancing CaPre towards a Phase 3 clinical trial later this year."

Key Developments


--  The full report of Acasti's completed Bridging Study for CaPre was
    submitted to the FDA. The Corporation has an End of Phase 2 meeting
    scheduled with the FDA in the first quarter of 2017, and plans to
    discuss the Bridging Study results with the agency and to gain their
    guidance on Acasti's development program and planned Phase 3 clinical
    study protocol in patients with severe hypertriglyceridemia.
--  Acasti advanced the process leading to the cGMP manufacturing of CaPre
    for the planned Phase 3 clinical trial with qualified and experienced
    pharmaceutical CMOs, including the installation and qualification of the
    Acasti owned proprietary extraction and purification equipment, which
    led to the first engineering production run of CaPre in December 2016.
--  Acasti appointed Linda P. O'Keefe as chief financial officer effective
    November 25, 2016. Ms. O'Keefe is an accomplished CFO and finance
    executive with experience in public small cap and multi-national
    companies, private start-ups in the life sciences industry, as well as
    with venture capital and private equity firms. Her track-record includes
    finance, accounting and back office administrative leadership roles.

Third Quarter 2017 and Year-to-Date Financial Results(1)


--  Net loss was $2.4 million or $0.22 loss per share for the third quarter,
    compared to a net loss of $2.2 million or $0.21 loss per share in the
    third quarter of last fiscal year. Net loss was $7.9 million or $0.74
    loss per share for the first nine months of fiscal 2017, compared to a
    net loss of $4.4 million or $0.41 loss per share for the same period of
    the last fiscal year. The higher net loss for the current nine-month
    period was primarily based on last year's net loss being reduced by a
    $2.0 million incremental decreased value of derivative warrant
    liabilities, a $1.0 million change from a foreign exchange gain last
    year to a foreign exchange loss in the current year, and increased
    general and administrative (G&A) expenses.
--  Research and development (R&D) expenses were $1.7 million for the third
    quarter, down from $2.2 million in the third quarter of fiscal 2016. The
    current quarter's lower R&D expenses are primarily attributed to the
    change in the year-to-year mix of clinical and production activities and
    the timing of related expenses, including the current year's project
    expenses not all being incurred during the full quarter. As Acasti
    continues as planned on its previously announced timeline for the
    conduct of its clinical program, R&D expenses were $5.7 million for the
    first nine months of fiscal 2017, a decrease from $5.8 million for the
    same period last year.
--  General and administrative expenses were $0.8 million for the third
    quarter, up from $0.5 million in the third quarter of fiscal 2016. The
    increase in G&A expenses during the current quarter was primarily made
    up of project expenses for the reactivation of the public and investor
    relations programs and achievement of business development milestones as
    well as nonrecurring legal professional fees associated primarily with
    the Corporation's year-end change and immigration activities for its
    U.S. executives. For the first nine months of fiscal 2017, G&A expenses
    were $2.3 million, an increase from $1.6 million for the same period
    last year, resulting primarily from the increased cost of the expanded
    executive team, led by the stock-based compensation impact, and an
    increase in the Corporation's market research expenses based on a change
    in expense classification.
--  Cash Flows - With cash and short-term investments of $5.8 million as of
    November 30, 2016, if Acasti does not raise additional funds, there
    exists a material uncertainty that casts substantial doubt about the
    Corporation's ability to continue as a going concern and, therefore,
    realize its assets and discharge its liabilities in the normal course of
    business. Management has reasonable expectation that the Corporation
    should be able to raise additional funds, assuming the successful
    completion of Acasti's previously announced financing initiatives.

(1) The quarterly unaudited financial statements with footnotes and the MD&A are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Acasti's website at www.acastipharma.com.

About Acasti Pharma

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. The Corporation's strategy is to initially develop and commercialize CaPre for the 3 to 4 million patients in the U.S. with severe hypertriglyceridemia. 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. For more information, visit www.acastipharma.com.

Forward Looking Statements

Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking information in this press release includes, but is not limited to, information or statements about Acasti's strategy, future operations, prospects and the plans of management; the completion of Acasti's previously announced financing initiatives in the timeframe anticipated; whether Acasti's previously announced financing initiatives will be successful; the timing of future meetings and discussions with the FDA and the outcome thereof.

The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest Annual Information Form, which also forms part of Acasti's latest annual report on Form 20-F and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml and on the investor section of Acasti's website at www.acastipharma.com (the "AIF"). All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including, without limitation, the failure to receive regulatory approvals (including stock exchange) or otherwise satisfy the conditions to the completion of Acasti's previously announced financing initiatives and the funds thereof not being available to the Corporation; anticipated studies and submissions to the FDA may not occur as currently anticipated, or at all; rejection by the FDA of Acasti's 505(b)(2) regulatory pathway approach; difficulties, delays or failures in obtaining regulatory approvals for the initiation of clinical trials; uncertainties related to the regulatory approval process; failure to achieve Acasti's publicly announced milestones on time; the net proceeds from Acasti's previously announced financing initiatives and existing cash, together with interest thereon, may not be sufficient to fund Acasti's operations through December 31, 2017; Acasti has a history of negative operating cash flow and may never become profitable or be able to sustain profitability; Acasti will have significant additional future capital needs and may not be able to raise additional financing required to fund further research and development, clinical studies, obtain regulatory approvals, and to meet ongoing capital requirements to continue current operations on commercially acceptable terms or at all.

Certain important assumptions by Acasti in making forward-looking statements include, but are not limited to, the satisfaction of all conditions to completion of Acasti's previously announced financing initiatives; the receipt of required regulatory approvals (including stock exchange approvals) and successful completion of Acasti's previously announced financing initiatives in the time frame anticipated; confirmation by the FDA of Acasti's 505(b)(2) regulatory pathway approach and finalization of the protocol for the Phase 3 trial for CaPre within the anticipated timeframe; the Corporation's ability to achieve its publicly announced milestones on time; the Corporation's ability to continue as a going concern; and Acasti's ability to obtain additional capital and financing as needed on favorable terms. Additional information about these assumptions and risks and uncertainties is contained in the AIF and in the Corporation's most recent management's discussion and analysis (MD&A), in each case under the heading "Risk Factors."

Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
21st International Cloud Expo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Me...
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
SYS-CON Events announced today that Datera, that offers a radically new data management architecture, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera is transforming the traditional datacenter model through modern cloud simplicity. The technology industry is at another major inflection point. The rise of mobile, the Internet of Things, data storage and Big...
"Outscale was founded in 2010, is based in France, is a strategic partner to Dassault Systémes and has done quite a bit of work with divisions of Dassault," explained Jackie Funk, Digital Marketing exec at Outscale, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We were founded in 2003 and the way we were founded was about good backup and good disaster recovery for our clients, and for the last 20 years we've been pretty consistent with that," noted Marc Malafronte, Territory Manager at StorageCraft, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Kubernetes is an open source system for automating deployment, scaling, and management of containerized applications. Kubernetes was originally built by Google, leveraging years of experience with managing container workloads, and is now a Cloud Native Compute Foundation (CNCF) project. Kubernetes has been widely adopted by the community, supported on all major public and private cloud providers, and is gaining rapid adoption in enterprises. However, Kubernetes may seem intimidating and complex ...
While the focus and objectives of IoT initiatives are many and diverse, they all share a few common attributes, and one of those is the network. Commonly, that network includes the Internet, over which there isn't any real control for performance and availability. Or is there? The current state of the art for Big Data analytics, as applied to network telemetry, offers new opportunities for improving and assuring operational integrity. In his session at @ThingsExpo, Jim Frey, Vice President of S...
"DivvyCloud as a company set out to help customers automate solutions to the most common cloud problems," noted Jeremy Snyder, VP of Business Development at DivvyCloud, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We focus on SAP workloads because they are among the most powerful but somewhat challenging workloads out there to take into public cloud," explained Swen Conrad, CEO of Ocean9, Inc., in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"As we've gone out into the public cloud we've seen that over time we may have lost a few things - we've lost control, we've given up cost to a certain extent, and then security, flexibility," explained Steve Conner, VP of Sales at Cloudistics,in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We provide IoT solutions. We provide the most compatible solutions for many applications. Our solutions are industry agnostic and also protocol agnostic," explained Richard Han, Head of Sales and Marketing and Engineering at Systena America, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
DX World EXPO, LLC., a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"I think DevOps is now a rambunctious teenager – it’s starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are still a relatively small software house and we are focusing on certain industries like FinTech, med tech, energy and utilities. We help our customers with their digital transformation," noted Piotr Stawinski, Founder and CEO of EARP Integration, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.