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Zomedica Provides Update on Pipeline Development and Announces At-The-Market Offering Program
ANN ARBOR, Mich., Dec. 20, 2018 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, today provided an update on its pipeline development and announced the entering into of an at-the-market equity offering sales agreement with Cantor Fitzgerald & Co.
“2018 was an industrious year in the development and expansion of our diagnostic pipeline alongside the continued development of our therapeutic candidates,” stated Gerald Solensky, Jr., Chairman and Chief Executive Officer at Zomedica. “We expect to provide study data, clinical data and key development insights throughout 2019 as we continue to work diligently on our pipeline.”
ZM-024: Point-of-care diagnostic platform for performing immunodiagnostic testing
As previously announced, in November Zomedica partnered with Qorvo Biotechnologies, LLC (Qorvo) to collaborate on the development of a collection of rapid veterinary diagnostic assays for the performance of immunodiagnostic testing. Joint development work initially targets five assay candidates to detect certain thyroid and adrenal disorders in dogs and cats, which currently require reference lab immunoassay testing for reliable diagnostic results.
Zomedica expects to complete assay verifications for ZM-024 in Q4 2019, followed by validations in Q1 2020. Assuming successful completion of the development work, we expect to commence the marketing of this platform in the first half of 2020 for the initial five assay candidates, which we believe do not require pre-market regulatory approval by U.S. regulators.
ZM-024 is an investigational device, is not currently available for sale, and is limited to investigational use only.
ZM-020: Point-of-care pathogen detection platform
As previously disclosed, Zomedica is developing an in-clinic diagnostic analyzer with the potential to screen for pathogens in companion animals, beginning with fecal and urine samples.
In Zomedica’s early development work, the ZM-020 platform has successfully detected 13 unique urine pathogen signatures in water, including seven different gram positive and gram negative bacteria species and three types of crystals with greater than 93.93 percent sensitivity and 99.32 percent specificity in over 6,000 samples. Zomedica’s next development phase will seek to further optimize these results by moving beyond “spiked” water samples to automated detection of these signatures in urine samples. If development work progresses as anticipated, Zomedica expects to commence validation for its UTI assay and verification for its fecal assay in Q1 2019. We believe that ZM-020 does not require pre-market regulatory approval by U.S. regulators. Assuming that the development work is successfully completed, Zomedica expects to commence marketing ZM-020 in the first half of 2020.
We intend to develop additional applications for the ZM-020 platform, including further development of the pathogen detection library for urine and fecal analysis as well as for respiratory and dermatological analysis.
ZM-017: Circulating tumor cell assay platform for dogs
As previously disclosed, Zomedica is developing a circulating tumor cell (CTC) “liquid biopsy” diagnostic assay with the goal of enabling veterinarians to detect hard-to-diagnose canine cancers, such as hemangiosarcoma and osteosarcoma, with a simple blood draw. During the second half of 2018, Zomedica filed two provisional patent applications with the United States Patent and Trademark Office for its assay development activities and is working to optimize and verify additional assays for the ZM-017 platform.
Zomedica extended validation of its initial cancer assay after continued verification efforts, performed in parallel with early clinical validation steps during 2018, revealed opportunities to further optimize the assay to achieve broader commercial potential. In 2019, Zomedica expects to initiate verification and validation efforts for its blood-borne lymphoma cancer assay. Assuming successful completion of the clinical validation, we expect to commence the marketing of ZM-017 during the second half of 2020.
ZM-007 and ZM-012: Metronidazole for acute diarrhea in dogs
ZM-007 and ZM-012 are complementary oral formulations of metronidazole targeting the treatment of acute diarrhea in dogs. ZM-007 is an oral suspension for use with small dogs and puppies under nine pounds or four kilograms, currently only available via compounding pharmacies, while ZM-012 is a tablet formulation currently only available as a human generic.
Zomedica expects to commence a pivotal safety study for ZM-007 in the first half of 2019 and will pursue approval of ZM-012 as a bioequivalent to ZM-007, assuming that ZM-007 is approved by the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM).
ZM-006: Transdermal methimazole for hyperthyroidism in cats
ZM-006 is a transdermal gel formulation of methimazole targeting the chronic treatment of hyperthyroidism in cats. Zomedica completed pilot testing to support our pivotal safety study in Q4 of 2018 and are analyzing the results. Zomedica expects to present and confirm the regulatory strategy and development plan for ZM-006 to the FDA-CVM in Q1 2019. Assuming that pilot testing is successful, Zomedica expects to commence the pivotal safety study in the first half of 2019. We also intend to initiate a pilot efficacy study in the first half of 2019.
ZM-011: Transdermal fluoxetine for behavioral disorders in cats
ZM-011 is a transdermal formulation of fluoxetine, most commonly known as Prozac®, intended to treat feline behavioral disorders, such as inappropriate urination. Zomedica believes that Fluoxetine continues to be a commonly compounded drug used by veterinarians. Pilot testing of ZM-011 to support our pivotal safety study was completed in 2018 and we are analyzing the results. Assuming that such pilot testing is successful, Zomedica expects to commence a pivotal safety study for ZM-011 in the second half of 2019.
As our development work progresses, Zomedica has also focused on building brand and product awareness as a valued veterinary partner with clinical practitioners. In Q4 2018, Zomedica initiated a strategic customer development initiative, which includes the expansion of its Voice of the Vet™ programming for veterinarians, veterinary technicians and nurses, practice managers and hospital administrators, as well as veterinary students. Zomedica also intends to provide educational white papers for its canine cancer diagnostic platform ZM-017 and its point-of-care pathogen detection platform ZM-020 in early 2019.
SHELF REGISTRATION STATEMENT AND AT-THE-MARKET OFFERING PROGRAM
Zomedica also announced that it has filed with the United States Securities and Exchange Commission (SEC) a universal shelf registration statement on Form S-3 covering the issuance and sale in the United States from time to time of up to $300.0 million of its securities. In connection therewith, Zomedica also entered into an at-the-market equity offering sales agreement with Cantor Fitzgerald & Co., effective as of December 20, 2018, under which Zomedica may sell pursuant to the universal shelf registration statement common shares in the United States only, from time to time, for up to $50.0 million in aggregate sales proceeds in "at the market" transactions.
The registration statement has been filed but has not been declared effective by the SEC. No sales of the securities covered by the registration statement, including sales of common shares pursuant to the sales agreement, may be made prior to the effectiveness of the registration statement. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities being offered, nor may there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state or other jurisdiction.
Based in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) (TSX-V: ZOM) is a veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include novel diagnostics and innovative therapeutics that emphasize patient health and practice health. With a team that includes clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.
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