Positive Preclinical Results and Patent Allowed for Aequus’ Once-Weekly Transdermal Aripiprazole

Jul 23, 2015

Vancouver, BC – July 23, 2015. Aequus Pharmaceuticals, Inc., “Aequus” (TSX-V: AQS), announced today they have successfully completed an in vivo feasibility study with AQS-1301, a proprietary transdermal patch containing the psychoactive drug, aripiprazole. A pharmacokinetic study was conducted in animals in order to estimate the effectiveness of the novel formulation in delivering therapeutic amounts of the drug over a 7 day period.

“We were very pleased that the patch delivered drug at a very consistent rate over the 7 day period. This is an essential feature of a once-weekly therapeutic”, said Douglas Janzen, Chairman and CEO of Aequus. Estimates from the experimental data predict that therapeutic levels of aripiprazole will be achieved with a reasonably-sized patch in human clinical trials expected to begin later this year.

Aequus also announced it has received a Notice of Allowance from the U.S. Patent Trademark Office (USPTO) for a pharmaceutical formulation patent application that covers AQS-1301, a once-weekly transdermal formulation of aripiprazole. The patent to be issued from this allowed application is titled “Aripiprazole compositions and methods for its transdermal delivery”. Similar applications have been filed with the European Patent Office (EPO) and the Patent Cooperation Treaty (PCT). This is the first approved of several patent applications filed covering AQS-1301, which Aequus has exclusively licensed from Transdermal Research Pharm Laboratories.

“We will continue to be focused on building on our patent portfolio as we further investigate AQS-1301,” said Anne Stevens, COO and Director of Aequus. “Today’s events greatly support the commercial potential of this product which we believe could provide increased benefits to patients in need of this important drug.”

The oral, once-daily formulation of aripiprazole is currently marketed under the trade name Abilify ®, which is an atypical antipsychotic used for the treatment of bipolar I disorder, schizophrenia, irritability associated with autistic disorder, and major depressive disorder. Abilify ® is a market leader in the U.S., and Aequus believes it has limitations due to its daily dosing regimen which is associated with a high rate of non-adherence and relapse. Aequus’ proposed transdermal, once-weekly aripiprazole patch is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations. By delivering aripiprazole over seven days in a comfortable, convenient and easy-to-use weekly patch, AQS-1301 is intended to promote enhanced patient compliance.

About Aequus Pharmaceuticals

Aequus Pharmaceuticals Inc. (TSX-V: AQS) is a Vancouver-based specialty pharmaceutical company focused on developing, advancing and promoting differentiated products in Canada. Aequus’ development pipeline focuses on enhancing delivery methods for approved drugs that are limited by non-compliance, high frequency dosing, first-pass metabolism side-effects, painful injections, or where the therapeutic profile can be improved by making an alternative delivery system available. Aequus is developing several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. Aequus intends to commercialize its internal programs within Canada and to establish strategic partnerships to accelerate and maximize the potential of its product candidates worldwide. For further information, please visit www.aequuspharma.ca.

This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward- looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements include but are not limited to statements relating to: the implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launches; the Company’s expected revenues; the regulatory approval of its products; the Company’s ability to attract international partners; and ongoing discussions with and the Company’s ability to secure potential partners to further grow our product portfolio. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to: obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully out license or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; the impact of the coronavirus (COVID-19) on the Company’s operations; and the Company’s ability to protect patents and proprietary rights. In evaluating forward looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Annual Information Form dated April 30, 2021, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward looking statements.
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