SOUTH SAN FRANCISCO, CA / ACCESSWIRE / June 25, 2019 / VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today reported financial results for its fiscal year ended March 31, 2019 and provided an overview of operational highlights on its CNS pipeline.
“We are excited about our progress and recent developments involving AV-101, our novel, oral NMDA receptor glycine site antagonist. VistaGen is on track to reach target enrollment in ELEVATE, our Phase 2 study of AV-101 as a new generation treatment of major depressive disorder, during next quarter, with topline results expected in the second half of 2019. In addition, we are delighted with recently reported preclinical data supporting AV-101’s potential in two additional large CNS markets with high unmet need, neuropathic pain and levodopa-induced dyskinesia affecting individuals with Parkinson’s disease,” said Shawn Singh, Chief Executive Officer of VistaGen.
“We are also pleased with FDA feedback regarding our plans for pivotal Phase 3 development of PH94B, our novel, rapid-acting neuroactive nasal spray for treatment of social anxiety disorder. With the growing misuse of benzodiazepines already at epidemic levels, we are very optimistic about PH94B’s potential to transform the treatment paradigm for social anxiety disorder and reduce significantly or, ideally, eliminate current off-label use and misuse of benzodiazepines to treat this widespread and debilitating disorder. In addition, we believe successful Phase 2a study results support the potential of PH94B as a new treatment for generalized anxiety disorder and PH10, our second novel, rapid-acting, neuroactive nasal spray, as a novel first-line treatment for major depressive disorder. The multiple late-stage opportunities for VistaGen’s pipeline to address large CNS market needs are robust, and we look forward to keeping our shareholders informed of our continued progress,” added Mr. Singh.
CNS Pipeline Update:
VistaGen’s CNS investigational pipeline currently contains three late-stage (in Phase 2 or entering Phase 3) product candidates, AV-101, PH94B, and PH10.
Upcoming Clinical Milestones:
Fiscal Year Ended March 31, 2019 Financial Highlights:
Net loss attributable to common stockholders for the fiscal year ended March 31, 2019 was $25.7 million compared to $15.6 million for the fiscal year ended March 31, 2018. Net loss in fiscal 2019 included aggregate noncash expense of approximately $8.2 million, including $4.25 million for the acquisition of exclusive worldwide licenses to develop and commercialize our two novel, late-stage, neuroactive nasal spray product candidates, PH94B and PH10, through the issuance of unregistered shares of VistaGen’s common stock.
Research and development expense totaled approximately $17.1 million in fiscal 2019, compared with approximately $7.8 million in fiscal 2018. The increase in fiscal 2019 is primarily attributable to (i) expense related to conducting the ELEVATE study throughout fiscal 2019, (ii) noncash expense of $4.25 million related to acquisition of our licenses to PH94B and PH10 through the issuance of unregistered shares of VistaGen common stock, and (iii) nonclinical activities, including manufacturing expense associated with the production of AV-101 for preclinical and clinical studies.
General and administrative expense was approximately $7.5 million in fiscal 2019, compared to approximately $6.4 million in fiscal 2018, primarily as a result of increased noncash stock-based compensation expense in fiscal 2019.
At March 31, 2019, VistaGen had cash and cash equivalents of approximately $13.1 million.
As of June 24, 2019, there were 42,622,965 shares of common stock outstanding.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders with high unmet need. VistaGen’s pipeline includes three CNS drug candidates, AV-101, PH10 and PH94B. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This release contains various statements concerning VistaGen’s future expectations, plans and prospects, including without limitation, our expectations regarding development and commercialization of our drug candidates, including AV-101 for MDD, NP, LID and suicidal ideation, PH94B for SAD, and PH10 for MDD, as well as our intellectual property and commercial protection of our drug candidates, all of which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and may cause actual results to differ materially from those contemplated in these forward-looking statements. Those risks include the following: (i) we may encounter unexpected adverse events in patients during our clinical development of any product candidate that cause us to discontinue further development; (ii) we may not be able to successfully demonstrate the safety and efficacy of our product candidates at each stage of clinical development; (iii) success in preclinical studies or in early-stage clinical trials may not be repeated or observed in ongoing or future studies, and ongoing or future preclinical and clinical results may not support further development of, or be sufficient to gain regulatory approval to market AV-101, PH94B, and/or PH10; (iv) decisions or actions of regulatory agencies may negatively affect the progress of, and our ability to proceed with, further clinical studies or to obtain marketing approval for our drug candidates; (v) we may not be able to obtain or maintain adequate intellectual property protection and other forms of marketing and data exclusivity for our product candidates; (vi) we may not have access to or be able to secure substantial additional capital to support our operations, including our ongoing clinical development activities; and (vii) we may encounter technical and other unexpected hurdles in the manufacturing and development of any of our product candidates. Certain other risks are more fully discussed in the section entitled “Risk Factors” in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and Exchange Commission (SEC). Our SEC filings are available on the SEC’s website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: IR@vistagen.com
Investor Contact
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
Media Contact
Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications
Phone: +1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
VISTAGEN THERAPEUTICS
Consolidated Balance Sheets
(Amounts in dollars, except share amounts)
March 31,
|
March 31,
|
|||||||
2019
|
2018
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 13,100,300 | $ | 10,378,300 | ||||
Receivable from supplier
|
300,000 | – | ||||||
Prepaid expenses and other current assets
|
250,900 | 644,800 | ||||||
Total current assets
|
13,651,200 | 11,023,100 | ||||||
Property and equipment, net
|
312,700 | 207,400 | ||||||
Security deposits and other assets
|
47,800 | 47,800 | ||||||
Total assets
|
$ | 14,011,700 | $ | 11,278,300 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 1,055,000 | $ | 1,195,700 | ||||
Accrued expenses
|
1,685,600 | 206,300 | ||||||
Current notes payable
|
57,300 | 53,900 | ||||||
Capital lease obligations
|
3,000 | 2,600 | ||||||
Total current liabilities
|
2,800,900 | 1,458,500 | ||||||
Non-current liabilities:
|
||||||||
Accrued dividends on Series B Preferred Stock
|
3,748,200 | 2,608,300 | ||||||
Deferred rent liability
|
381,100 | 285,600 | ||||||
Capital lease obligations
|
6,300 | 9,300 | ||||||
Total non-current liabilities
|
4,135,600 | 2,903,200 | ||||||
Total liabilities
|
6,936,500 | 4,361,700 | ||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2019 and 2018:
|
||||||||
Series A Preferred, 500,000 shares authorized, issued and outstanding at March 31, 2019 and 2018
|
500 | 500 | ||||||
Series B Preferred; 4,000,000 shares authorized at March 31, 2019 and 2018; 1,160,240 shares issued and outstanding at March 31, 2019 and 2018
|
1,200 | 1,200 | ||||||
Series C Preferred; 3,000,000 shares authorized at March 31, 2019 and 2018; 2,318,012 shares issued and outstanding at March 31, 2019 and 2018
|
2,300 | 2,300 | ||||||
Common stock, $0.001 par value; 100,000,000 shares authorized at March 31, 2019 and 2018; 42,758,630and 23,068,280 shares issued and outstanding at March 31, 2019 and March 31, 2018, respectively
|
42,800 | 23,100 | ||||||
Additional paid-in capital
|
192,129,900 | 167,401,400 | ||||||
Treasury stock, at cost, 135,665 shares of common stock held at March 31, 2019 and 2018
|
(3,968,100 | ) | (3,968,100 | ) | ||||
Accumulated deficit
|
(181,133,400 | ) | (156,543,800 | ) | ||||
Total stockholders’ equity
|
7,075,200 | 6,916,600 | ||||||
Total liabilities and stockholders’ equity
|
$ | 14,011,700 | $ | 11,278,300 |
VISTAGEN THERAPEUTICS
STATEMENT OF OPERATIONS
Amounts in Dollars, except share amounts
Fiscal Years Ended March 31,
|
||||||||
2019
|
2018
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$ | 17,098,500 | $ | 7,762,500 | ||||
General and administrative
|
7,457,800 | 6,437,100 | ||||||
Total operating expenses
|
24,556,300 | 14,199,600 | ||||||
Loss from operations
|
(24,556,300 | ) | (14,199,600 | ) | ||||
Other expenses, net:
|
||||||||
Interest expense, net
|
(8,000 | ) | (8,900 | ) | ||||
Loss on extinguishment of accounts payable
|
(22,700 | ) | (135,000 | ) | ||||
Loss before income taxes
|
(24,587,000 | ) | (14,343,500 | ) | ||||
Income taxes
|
(2,600 | ) | (2,400 | ) | ||||
Net loss and comprehensive loss
|
(24,589,600 | ) | (14,345,900 | ) | ||||
Accrued dividend on Series B Preferred stock
|
(1,139,900 | ) | (1,030,400 | ) | ||||
Deemed dividend from trigger of down round
|
||||||||
provision feature
|
– | (199,200 | ) | |||||
Net loss attributable to common stockholders
|
$ | (25,729,500 | ) | $ | (15,575,500 | ) | ||
Basic and diluted net loss attributable to common
|
||||||||
stockholders per common share
|
$ | (0.90 | ) | $ | (1.12 | ) | ||
Weighted average shares used in computing
|
||||||||
basic and diluted net loss attributable to common
|
||||||||
stockholders per common share
|
28,562,490 | 13,890,041 |
SOURCE: VistaGen Therapeutics
View source version on accesswire.com:
https://www.accesswire.com/549848/VistaGen-Therapeutics-Reports-Fiscal-Year-2019-Results-and-Provides-CNS-Pipeline-Overview
Hemogenyx Pharmaceuticals Receives IRB Approval for Phase 1 Clinical Trial of HEMO-CAR-T (HG-CT-1)LONDON, UK /…
SAN DIEGO, CA / ACCESSWIRE / November 21, 2024 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular…
BEVERLY HILLS, CALIFORNIA / ACCESSWIRE / November 21, 2024 / Nicole Garrett, CEO of Under…
HUNTINGTON BEACH, Calif., Nov. 21, 2024 /PRNewswire/ -- Beacon Healthcare Systems, is pleased to announce…
Attributes Revenue Growth to Innovative Partnerships, Strong Team, and Unique Value-Based Care Model NEW YORK,…
Automation That Makes a Difference SUNRISE, Fla., Nov. 21, 2024 /PRNewswire/ -- When it comes…