OREANDA-NEWS. Nexvet Biopharma , a veterinary biologics developer, today announced its financial results for the three and nine-month periods ended March 31, 2016.

Recent company highlights include:

  • Advanced clinical development and regulatory preparations for ranevetmab (NV-01), for the control of pain associated with osteoarthritis in dogs
  • Completed enrollment of 126 cats in a pilot field safety and efficacy study of NV-02, for the control of pain associated with osteoarthritis in cats
  • Announced anti-PD-1 program for canine cancer under United States Department of Agriculture (USDA) jurisdiction, with new candidates showing binding and potent inhibition of canine PD-1

“I am pleased with the progress achieved during the quarter. Certainly, maintaining the development timelines for our lead product candidates is the top priority as we advance internal and partnered programs utilizing our proprietary PETization platform to create compelling treatments for unmet medical needs in dogs and cats. I’m also encouraged by the progress we’ve made in bringing our manufacturing facility, BioNua, on-line as managing in-house manufacturing is an essential component of our business strategy,” commented Dr. Mark Heffernan, Nexvet’s Chief Executive Officer.

An important accomplishment during the quarter was the successful completion of a pilot field study for ranevetmab, the Company's anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapy in development for the control of pain associated with osteoarthritis in dogs. This pilot field study was designed to evaluate a combination of doses and routes of administration to complement the pivotal safety and efficacy study for ranevetmab. In November of 2015, Nexvet announced that the completed pivotal study of ranevetmab demonstrated safety and efficacy (p? 0.038 for the primary endpoint) when administered by subcutaneous (SC) injection, once a month for three months. Results from the most recent pilot study confirmed ranevetmab’s safety and efficacy in a field study evaluating a range of dosages and treatment regimens (SC and intravenous administration) in an additional population of 176 dogs. The Target Animal Efficacy submission for ranevetmab is scheduled for submittal to the United States Food and Drug Administration’s Center for Veterinary Medicine by the end of the second calendar quarter of 2016.

During the period, the Company also completed enrollment for its pilot field safety and efficacy study of NV-02 for the control of pain associated with osteoarthritis in cats. This study remains on course to deliver initial data in the second calendar quarter of 2016. If supportive of further development, the data will inform the design of a pivotal safety and efficacy study for NV-02, to commence later this year.

Throughout the quarter, Nexvet continued to prepare the BioNua manufacturing facility in Tullamore, Ireland to become fully operational in mid-2016. Preparation of Chemistry, Manufacturing and Controls (CMC) materials has begun for ranevetmab and NV-02, inclusive of transitioning materials and processes from former contract manufacturers. A team of 20 process scientists, quality assurance personnel and support staff has been assembled, and the facility has obtained state-of-the-art large-scale disposable bioreactors, purification systems, UF/DF systems and support equipment which has been fully commissioned in preparation for manufacturing veterinary mAbs. In addition, facility upgrades have been made and a Good Manufacturing Practice facility ramp-up protocol has been initiated.

During the quarter, Nexvet advanced its anti-tumor necrosis factor (TNF) programs, having identified new, highly potent and neutralizing PETized dog and cat mAbs against this target. TNF is a focus of the Company’s programs in chronic inflammation, as targeting TNF has delivered several of the best-selling anti-inflammatory drugs in human medicine. Nexvet’s proof-of-concept studies demonstrated that NV-08 (a canine TNF receptor fusion protein) produced an anti-inflammatory effect in dogs; the Company’s new anti-TNF mAbs will progress into proof-of-concept and will replace the receptor fusion protein candidates (including NV-08) due to a more favorable target product profile based on their longer half-life and anticipated need for less frequent dosing.

In April 2016, the Company announced the successful PETization of fully canine mAbs against programmed cell death protein 1 (PD-1). The anti-PD-1 program is based on mAbs identified by Nexvet’s research and development collaborator, Zenoaq (Nippon Zenyaku Kogyo Co., Ltd.), a leading Japanese animal health company. The program has demonstrated binding and potent inhibition of canine PD-1, and will now enter further safety, pharmacokinetic and immunogenicity studies. The USDA’s Center for Veterinary Biologics has confirmed jurisdiction over the regulatory path for this program, providing an opportunity for conditional licensure*.

Third Quarter 2016 Financial Results

As of March 31, 2016, Nexvet had cash of $37.2 million.

For the three months ended March 31, 2016, Nexvet reported a net loss of $5.8 million, compared to $2.7 million for the three months ended March 31, 2015. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2016 was $0.50, compared to $0.36 for the three months ended March 31, 2015.

The net loss of $5.8 million for the three months ended March 31, 2016 included operating expenses of $6.0 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income comprised $0.2 million, principally research and development income of $0.4 million offset by an exchange loss of $0.3 million.

The net loss of $2.7 million for the three months ended March 31, 2015 included operating expenses of $5.1 million, reflecting $2.7 million in research and development expenses and $2.4 million in general and administrative expenses. Other income comprised $2.4 million, principally research and development income of $1.0 million and an exchange gain of $1.3 million.

For the nine months ended March 31, 2016, Nexvet reported a net loss of $15.4 million, compared to $7.4 million for the nine months ended March 31, 2015. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2016 was $1.34, compared to $2.30 for the nine months ended March 31, 2015.

The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income comprised $1.7 million, principally research and development income of $1.4 million, an exchange gain of $0.2 million and interest income of $0.1 million.

The net loss of $7.4 million for the nine months ended March 31, 2015 included operating expenses of $15.1 million, reflecting $7.4 million in research and development expenses and $7.7 million in general and administrative expenses. Other income comprised $7.7 million, principally research and development income of $2.7 million, an exchange gain of $4.6 million and government grant income of $0.4 million.

The increased operating expenses for both the three and nine month periods ended March 31, 2016, compared to the corresponding periods in 2015, primarily reflect research and development costs associated with building our team, particularly within our manufacturing facility, and conducting field studies of our lead programs, offset by a reduction in general and administrative costs primarily due to incurring costs in 2015 associated with preparation for our initial public offering and Irish reorganization.