Nexvet Biopharma (NASDAQ:NVET) today announced its financial results for the three month period ended September 30, 2016.

Recent highlights include:

Advanced preparations for pivotal studies of the anti-NGF mAb therapy frunevetmab for cats and a pivotal safety study of the anti-NGF mAb therapy ranevetmab for dogs.

Initiated a pivotal target animal safety study of frunevetmab in October

Announced publication of two peer-reviewed articles regarding frunevetmab in the Journal of Veterinary Internal Medicine.

Received cash of $1.62 million in research and development income from the Australian Government in October.

“Throughout the quarter, our top priority has been maintaining the development momentum of ranevetmab and frunevetmab, our lead anti-nerve growth factor (NGF) monoclonal antibody (mAb) programs for chronic pain in dogs and cats, respectively. We were pleased to recently initiate a pivotal safety study of frunevetmab. For both lead product candidates, we also recently achieved significant progress across regulatory and Chemistry, Manufacturing and Controls (CMC) activities,” commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.

During the quarter, the Company completed analysis of its successful pilot study of frunevetmab and used this analysis to inform the design of a pivotal field efficacy and safety study. Protocol concurrence with the United States Food and Drug Administration’s Center for Veterinary Medicine (CVM) has been obtained for this study. The study’s clinical sites have been selected, trial material manufacture has been completed, and investigator training began in October. The pivotal target animal safety study, which commenced in late October, will examine the safety of frunevetmab in cats according to standard Veterinary International Conference on Harmonization (VICH) guidance and a protocol previously concurred with CVM.

In support of the Company’s frunevetmab CMC technical section submission to CVM, a second 200 liter batch of frunevetmab was produced during the quarter at BioNua, the Company’s manufacturing division in Ireland, which is also being prepared for commercial manufacturing of Nexvet’s products.

Ranevetmab’s process validation, CMC documentation, and production scale-up continue to advance in preparation for CMC regulatory filings, along with preparation for a pivotal target animal safety study which is expected to commence in the first half of 2017.

During the quarter, the Company also initiated pharmacokinetic, immunogenicity and preliminary safety proof-of-concept studies for its anti-PD-1 program. This immuno-oncology program aims to deliver therapies which may have efficacy in a variety of canine cancers.

In July, the Company announced the publication of two peer-reviewed papers regarding frunevetmab (formerly “NV-02”) in the Journal of Veterinary Internal Medicine (JVIM). Frunevetmab is being developed as a monthly subcutaneous injectable for the control of pain associated with osteoarthritis in cats.

On October 10, 2016 Nexvet received cash of $1.62 million under the Australian Government’s research and development incentive program in respect of the fiscal year ended June 30, 2016.

First Quarter 2017 Financial Results

As of September 30, 2016, Nexvet had cash of $24.6 million.

For the three months ended September 30, 2016, Nexvet reported a net loss of $5.1 million, compared to $4.0 million for the three months ended September 30, 2015. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended September 30, 2016 was $0.44, compared to $0.35 for the three months ended September 30, 2015.

The net loss of $5.1 million for the three months ended September 30, 2016 included operating expenses of $5.7 million, reflecting $3.5 million in research and development expenses and $2.2 million in general and administrative expenses. Other income comprised $0.6 million, principally research and development income of $0.5 million and government grant income of $0.2 million, offset by an exchange loss of $0.1 million.

The net loss of $4.0 million for the three months ended September 30, 2015 included operating expenses of $5.6 million, reflecting $3.7 million in research and development expenses and $1.9 million in general and administrative expenses. Other income comprised $1.6 million, principally research and development income of $0.6 million and an exchange gain of $1.0 million.

About Nexvet (www.nexvet.com)

Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.

Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts biomanufacturing in Ireland.