Aequus Announces Advancement of Anti-Nausea Transdermal Extended-Release Patent Application

Aug 5, 2016

Vancouver, BC. AUGUST 5, 2016 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has filed an international patent application with the US Patent & Trademark Office (USPTO) that covers transdermal extended-release formulations of doxylamine succinate and pyridoxine hydrochloride in combination, relating to the Company’s AQS1303 program to treat pregnant women experiencing nausea and vomiting. This is the conversion of a provisional application which was filed on August 17, 2015, and is based on positive results from both in-vivo and in-vitro studies. Aequus owns the world-wide rights to the formulations described in the patent application.

The doxylamine/pyridoxine combination is currently marketed as Diclegis ® (US) / Diclectin ® (Canada) for the treatment of nausea and vomiting of pregnancy (NVP), as an oral tablet dosed up to four times per day. According to US IMS data, Diclegis sales have been growing steadily since the product’s 2013 US launch, reaching approximately $120 million USD in 2015. It is estimated that 70% of women experience NVP, and in some severe cases it may persist throughout their entire pregnancy. NVP can have a significant impact on expectant mothers’ quality of life. The initial approach in managing NVP is to make dietary changes including the avoidance of trigger odors and foods. If that approach does not resolve symptoms on its own, guidance recommends the addition of pharmacotherapy. Diclegis ® / Diclectin ® is the only FDA- and Health Canada- approved medication recommended for the treatment of NVP.

The AQS1303 transdermal doxylamine/pyridoxine combination patch is being developed as a once-daily and up to a once-weekly form to provide women with a more convenient and easy to administer option. Aequus has engaged with over 400 new and expectant mothers and received resounding feedback regarding the level of discomfort associated with taking oral medication to manage their nausea and vomiting symptoms. This includes experiencing gag reflexes and vomiting immediately after taking a pill, leaving patients uncertain as to whether the medication has been absorbed and if taking another dose is required. A transdermal patch would provide patients with steady delivery of the medication without the requirement to ingest an oral dose.

“In my mind, this is one of the most intuitive uses for a transdermal patch,” said Anne Stevens, COO and Director of Aequus. “We are looking forward to providing women with an easy to use and convenient alternative to manage their nausea and vomiting symptoms during pregnancy.”

“This is another step forward in cultivating what is becoming a robust intellectual property portfolio,” said Doug Janzen, Chairman and CEO of Aequus. “As we advance each of our internal programs, our goal is to ensure we position ourselves in the best way possible to establish meaningful partnerships that will maximize the return to shareholders.”

ABOUT AEQUUS PHARMACEUTICALS

Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes 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 in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visit www.aequuspharma.ca.

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FORWARD-LOOKING STATEMENT DISCLAIMER

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.

Aequus Contact Information
‍investors@aequuspharma.ca
604-336-7906