SOURCE: Aequus Pharmaceuticals

Aequus Pharmaceuticals

August 29, 2017 16:30 ET

Aequus Provides Second Quarter 2017 Operational Highlights

VANCOUVER, BC--(Marketwired - August 29, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the three months ended June 30, 2017 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.

Key Highlights

  • Entered into a commercial collaboration with Santen Pharmaceutical Co., Ltd. (Santen) to become its exclusive promotional and marketing partner for an ophthalmology product in Canada which is currently under review by Health Canada;
  • Initiated a proof of concept clinical study for its long acting transdermal anti-nausea program, with results expected by the end of the current quarter;
  • Advanced its once-weekly transdermal aripiprazole program through the completion of a successful second proof of concept clinical studies and positive regulatory meeting with the US Food and Drug Association (FDA);
  • 58% growth in revenue and net loss decrease of 9% compared to same quarter last year;
  • Cannabinoid franchise advanced through collaborations with the Centre for Drug Research and Development (CDRD), and a strategic supply agreement with Scientus;
  • Renewed the previous Shelf prospectus which has been in effect since 2015. The new Shelf prospectus will be in effect until September 2019.

Commercial Activities

The Company recorded revenues of $186,586 in the three month period ending June 30, 2017, representing 58% of growth as compared to the same period in 2016. On a year-to-date basis, the Company recorded $479,588 in revenues in the six month period ending June 30, 2017, a 105% growth compared to the same period in 2016. Revenues were attributable to its promotional activities for its third party products, Tacrolimus IR and PRVistitan™.

Since the initiation of Aequus' promotional efforts in December 2015, the generic version of the most commonly used dose of tacrolimus IR (1mg) has experienced growth of 103% to date and continues to gain market share from branded tacrolimus alternatives. Since the launch of Vistitan™ in April 2016, and with the support of Aequus' promotional efforts, Vistitan™ has been successfully listed among 90% of private payor groups as well as a benefit under key provincial formularies, including the Ontario Drug Benefit Plan, Alberta Health and Manitoba Health.

The Company expects revenues from the promotional activities of these two products to continue to grow in the current year as they continue to penetrate market share held by the branded equivalent and similar medications within the class.

In Q2 2017, the Company added to its commercial pipeline as it entered into a promotional agreement with Santen, a market leader in Japan for prescription ophthalmology therapies, where Aequus will build on its existing sales infrastructure to promote and support the launch of an undisclosed ophthalmology product which is currently under review by Health Canada.

"The agreement with Santen that we entered into this quarter reinforces our commitment to provide patients with high-quality therapeutics, and adds to the commercial ophthalmology franchise we have been building at Aequus since the launch of Vistitan in 2016," said Doug Janzen, CEO and Chairman of Aequus. "We look forward to seeing continued growth on the revenue side of our business as we look to add additional products in the near term."

Development Program Activities

The Company incurred research and development ("R&D") expenses of $581,670 in Q2 2017 as compared to $291,748 in Q2 2016. The increase was attributable to the Company completing the follow-on Proof of Concept clinical study for AQS 1301 (a once-weekly transdermal formulation of aripiprazole), the preparation for and attendance of the AQS1301 Pre-IND Meeting, the development of clinical trial materials and the initiation of the Proof of Concept study for AQS1303 (a long-acting transdermal anti-nausea patch).

The Company recently completed its Proof of Concept study for AQS1303 and expects results to be announced within the current quarter.

The Company continued to progress its cannabinoid development program since licensing the rights to a cannabinoid transdermal patch in the first quarter of 2017. The Company entered into a research collaboration for cannabinoid-based therapeutics with the Centre for Drug Research and Development in the quarter to establish pre-clinical safety and efficacy of select cannabinoid-based therapeutics targeting neurological movement disorders. The Company further validated the need for improved delivery methods, quality controlled ingredients, and clinical data to support safety and efficacy in key therapeutic areas through a market research survey involving 410 physicians in both Canada and the United States in the quarter. These activities have allowed The Company to calibrate its approach to the burgeoning sector to ensure value is brought to both patient and physician in this unique therapeutic space.

Since the end of Q2 2017, the Company announced a strategic supply agreement with Scientus, a biopharmaceutical company focused on R&D and product commercialization for extracts and formulations related to medical cannabinoids; and a collaboration around clinical trial management with Ehave, a healthcare bioinformatics company whose platform efficiently captures, integrates, and delivers high-quality clinical data and treatment tools. Aequus looks to continue to build on this momentum in the coming quarters.

FINANCIAL STATEMENTS AND MD&A

Investors are encouraged to review Aequus' complete Financial Statements and Management's Discussion and Analysis ("MD&A") for the three and six months ended June 30, 2017, which are available on the Company's website at www.aequuspharma.ca and on SEDAR at www.sedar.com.

ABOUT AEQUUS PHARMACEUTICALS INC.

Aequus Pharmaceuticals Inc. (TSX VENTURE: 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. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. 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.

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; the Company's expected revenues; the timing of public listings; the timing of results of the Company's transdermal pyridoxine/doxylamine program's Proof of Concept clinical study; the Company's potential regional partnerships for its internal programs; the timing of public reimbursement decisions for Vistitan; the regulatory requirements for the its transdermal aripiprazole program; and the Company's expectations regarding the medical cannabis 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 positive results of clinical trials; obtaining regulatory approvals; general business and economic conditions; the Company's ability to successfully outlicense or sell its current products and in-license and develop new products; the assumption that the Company's current good relationships with its manufacturer and other 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; 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 29, 2016, 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.

Vistitan™: Trademark owned or used under license by Sandoz Canada Inc.

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