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
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Everyone wants to use containers, but monitoring containers is hard. New ephemeral architecture introduces new challenges in how monitoring tools need to monitor and visualize containers, so your team can make sense of everything. In his session at @DevOpsSummit, David Gildeh, co-founder and CEO of Outlyer, will go through the challenges and show there is light at the end of the tunnel if you use the right tools and understand what you need to be monitoring to successfully use containers in your...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Join IBM November 2 at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how to go beyond multi-speed it to bring agility to traditional enterprise applications. Technology innovation is the driving force behind modern business and enterprises must respond by increasing the speed and efficiency of software delivery. The challenge is that existing enterprise applications are expensive to develop and difficult to modernize. This often results in what Gartner calls ...
The age of Digital Disruption is evolving into the next era – Digital Cohesion, an age in which applications securely self-assemble and deliver predictive services that continuously adapt to user behavior. Information from devices, sensors and applications around us will drive services seamlessly across mobile and fixed devices/infrastructure. This evolution is happening now in software defined services and secure networking. Four key drivers – Performance, Economics, Interoperability and Trust ...
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.