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SOUTH SAN FRANCISCO, CA--(Marketwired - June 29, 2017) - VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today reported its financial results for its fiscal year ended March 31, 2017.
The Company also provided an update on its corporate progress, clinical status and anticipated milestones for AV-101, its orally available CNS prodrug candidate in Phase 2 development, initially as a new generation treatment for major depressive disorder (MDD).
"With a team of industry experts and a focused strategy in place, we have established a strong foundation and embarked on paths to achieve several key catalysts within the next 18 months. We anticipate our first catalyst within the next 9 months as the NIMH completes its AV-101 Phase 2 monotherapy study in MDD, a study being conducted and fully funded by the NIH. Additionally, we are working closely with the FDA and our Principal Investigator, Dr. Maurizio Fava of Harvard University Medical School, on our AV-101 Phase 2 adjunctive treatment study in MDD, which we anticipate will begin enrollment in the first quarter of 2018 and be completed by the end of 2018, with topline results available in the first quarter of 2019," commented Shawn Singh, Chief Executive Officer of VistaGen.
In addition to MDD, AV-101 may have therapeutic potential in several other CNS indications where modulation of NMDA receptors, activation of AMPA pathways and/or active metabolites of AV-101 play a key role, including for treatment of epilepsy, as a non-opioid alternative for management of neuropathic pain, and to address certain symptoms associated with Parkinson's disease and Huntington's disease.
Mr. Singh continued, "Our MDD clinical program is our top priority, and will remain so. Additionally, however, recent peer-reviewed publications suggest that AV-101 may have significant therapeutic potential as a non-opioid treatment alternative for pain management. We are also excited about AV-101's potential to reduce dyskinesia associated with standard levodopa, or L-DOPA, therapy for Parkinson's disease, based on results from previous non-clinical studies. Without diverting our priority focus on MDD, we plan to expand our AV-101 Phase 2 clinical program during the next year to include these important CNS indications with significant unmet need."
"We are also pleased to have advanced our cardiac stem cell program during fiscal 2017, through both our participation in the FDA's CiPA initiative focused on using novel human stem cell models to predict cardiac toxicity of new drug candidates long before animal and human studies, as well as our exclusive sublicense agreement with BlueRock Therapeutics, an emerging force in cardiac regenerative medicine, founded and funded by Bayer AG and Versant Ventures. Our initial revenue-generating milestone with BlueRock Therapeutics was completed during fiscal 2017. We are optimistic about this relationship's potential and the future of cardiac regenerative medicine. We believe these significant events over the past year have positioned us to create substantial value for our stakeholders in fiscal 2018 and beyond."
Potential Near-Term Milestones:
Operational Highlights During Fiscal 2017:
Achievements Related to Stem Cell Technologies
Advancement of AV-101 as a Potential, Non-Opioid Treatment Alternative for Chronic Pain
Bolstered Team with Industry Experts
Intellectual Property Accomplishments
Capital Market Highlights
Financial Results for the Fiscal Year Ended March 31, 2017:
Revenue for the fiscal year ended March 31, 2017 totaled $1.25 million and was attributable to a sublicense agreement with BlueRock Therapeutics, for certain rights to the Company's proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.
Research and development expense totaled $5.2 million for the fiscal year ended March 31, 2017, an increase of approximately 33% compared with the $3.9 million incurred for the fiscal year ended March 31, 2016. The increase in year-over-year research and development expense was attributable to increased focus on development of AV-101, including preparations to launch the Phase 2 Adjunctive Treatment Study in MDD.
General and administrative expense decreased to $6.3 million in the fiscal year ended March 31, 2017, from $13.9 million in the fiscal year ended March 31, 2016, primarily as a result of the decrease in non-cash stock compensation expense, partially offset by an increase in non-cash expense related to grants of equity securities in payment of certain professional services during fiscal 2017. Of the amounts reported, non-cash expenses, related primarily to grants or modifications of equity securities, totaled approximately $3.1 million in fiscal 2017 and $11.9 million in fiscal 2016.
Net loss for the fiscal years ended March 31, 2017 and 2016 was approximately $10.3 million and $47.2 million, respectively, the latter amount including a non-recurring, non-cash expense of approximately $26.7 million attributable to the extinguishment of approximately $15.9 million carrying value of prior indebtedness, including then-outstanding Senior Secured Convertible Notes, and conversion of such indebtedness into equity securities between May and September 2015 at a conversion price (stated value of the equity received) of $7.00 per share.
At March 31, 2017, the Company had a cash and cash equivalents balance of $2.9 million. Since late-March 2017, the Company sold units consisting of unregistered common stock and common stock warrants to accredited investors in a self-placed private placement, yielding approximately $1 million in cash proceeds to the Company.
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen's lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington's disease, L-Dopa-induced dyskinesia associated with Parkinson's disease and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.
VistaStem Therapeutics is VistaGen's wholly owned subsidiary focused on applying human pluripotent stem cell technology, internally and with collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells.
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful financing, launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and L-DOPA-induced dyskinesia associated with Parkinson's disease, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the Phase 2 clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
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