OREANDA-NEWS. Nexvet Biopharma, a veterinary biologic therapeutics company, today announced financial results for its 2016 fiscal year, which concluded on June 30, 2016.

Corporate Highlights:

  • Announced positive data from a multi-center, placebo-controlled, randomized, double-blind pivotal efficacy and field safety study of ranevetmab (or ‘NV-01’), which enrolled 262 dogs with naturally occurring osteoarthritis and met its primary endpoint. No significant adverse safety signals were observed. A pivotal safety study of ranevetmab is intended to commence in the first half of 2017.
  • Completed a successful multi-center, placebo-controlled, randomized, double-blind pilot field study of frunevetmab (or ‘NV-02’) which enrolled 126 cats with naturally occurring osteoarthritis. The study achieved multiple statistically significant improvements over placebo and no significant adverse safety signals were observed. These results informed the planning of a pivotal efficacy and field safety study of frunevetmab, to commence in the fourth quarter of 2016.
  • Secured a biologics manufacturing facility in Ireland, which is now fully operational and producing clinical material, with activity financially supported by the Irish Government.
  • Commenced research and development collaboration with Zenoaq (Nippon Zenyaku Kogyo Co., Ltd.), to develop therapeutic biologics for companion animals including PETized monoclonal antibodies (mAbs) against the immuno-oncology target programmed cell death protein 1 (PD-1) for the treatment of canine cancer.

“The past year was marked by further validation of our PETization platform and significant successes across clinical and corporate development fronts. In particular, we delivered positive results from multiple clinical studies of our advanced mAb programs ranevetmab and frunevetmab, while increasing our vertical integration through internalized manufacturing at BioNua. This facility is now capable of producing drug substance in quantities sufficient for further pivotal studies of our lead product candidates. In terms of our earlier stage candidates, we are progressing a number of new PETized candidates, including in canine cancer via our PD-1 program,” commented Dr. Mark Heffernan, Nexvet's Chief Executive Officer.

Throughout the year, Nexvet bolstered its clinical and corporate development initiatives. In July 2015, Nexvet announced the commencement of a research and development collaboration with leading Japanese animal health company, Zenoaq (Nippon Zenyaku Kogyo Co., Ltd.), to develop a number of therapeutic biologics for companion animals. In May 2016, the Company announced the development of PETized mAbs against the immuno-oncology target programmed cell death protein 1 (PD-1) for the treatment of canine cancer. This program has demonstrated binding and potency and has progressed into in vivo proof-of-concept.

In September 2015, the Company announced it had secured a biologics manufacturing facility in Ireland, to be operated by BioNua, a wholly-owned subsidiary of Nexvet. The transaction was supported by the Irish Government’s Department of Jobs, Enterprise & Innovation through IDA Ireland, their foreign investment agency. In June 2016, Nexvet announced the facility was fully operational and had produced the first batch of frunevetmab at a scale sufficient to supply planned pivotal studies and initial commercial supply.

In October 2015, Nexvet initiated a multi-center, placebo-controlled, randomized, double-blind pilot field study of frunevetmab (or ‘NV-02’), which enrolled 126 cats with naturally occurring osteoarthritis. In May 2016, the Company announced the successful completion of this study, which presented a variety of statistically significant improvements over placebo at multiple endpoints. No significant adverse safety signals were observed. These results informed the Company’s decision to progress frunevetmab into pivotal studies which are expected to commence during the fourth quarter of 2016.

In November 2015, the Company announced its multi-center, placebo-controlled, randomized, double-blind pivotal efficacy and field safety study of ranevetmab (or ‘NV-01’) had met its primary endpoint. This endpoint was agreed under protocol concurrence with the United States Food and Drug Administration’s Center for Veterinary Medicine (“U.S. FDA CVM”). The study also reached clinically meaningful magnitudes of benefit and statistically significant differences over placebo for the majority of the secondary endpoints. No significant adverse safety signals were observed. In March 2016, the Company announced the successful completion of a pilot field study of ranevetmab which evaluated a combination of doses and routes of administration and further supported the safety and efficacy of ranevetmab. These two studies informed the Effectiveness Technical Section regulatory filing for ranevetmab, which was submitted to the CVM in June 2016.

In June 2016, Nexvet presented expanded data from the ranevetmab pivotal efficacy and field safety study and the frunevetmab pilot field study at a Nexvet-hosted seminar at the American College of Veterinary Internal Medicine (ACVIM) Forum in Denver, Colorado. These data included comprehensive details around efficacy outcomes and their statistical significance, safety, as well as study design.

Full Year 2016 Financial Results:

As of June 30, 2016, the Company had cash of $31.5 million.

For the year ended June 30, 2016, the Company reported a net loss attributable to common shareholders of $19.4 million, or $1.68 per share, compared to $11.9 million and $2.27 per share for the year ended June 30, 2015. The weighted average number of ordinary shares outstanding utilized in the calculation of net loss per common share was 11,517,507 and 5,214,957 for the years ended June 30, 2016 and 2015, respectively.

Operating expenses increased by $2.2 million, from $20.0 million for the year ended June 30, 2015 to $22.2 million for the year ended June 30, 2016.  The higher operating expenses primarily reflected a $5.1 million increase in research and development expense, operating costs of our manufacturing facility and staffing to support the growth in our operations, offset by a $2.9 million decrease in general and administrative expense.

For the years ended June 30, 2016 and 2015, other income comprised research and development income of $2.1 million and $3.5 million, respectively, government grant income of $0.4 million and $0.4 million, respectively; and an exchange gain of $0.2 million and $4.2 million, respectively.