Full Press Release Details
VistaGen Therapeutics Reports Third Quarter Fiscal 2018 Financial
South San Francisco, CA (February 12, 2018)
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 financial results for its third fiscal
quarter ended December 31, 2017.
on our significant progress last quarter, our team is prepared and
eager to launch, during the current quarter, our AV-101 Phase 2
clinical development program, initially focused on adjunctive
treatment of Major Depressive Disorder patients with an inadequate
response to standard, FDA-approved antidepressants. This year has
the potential to be transformative for VistaGen and the millions of
depression patients seeking new generation treatment options that
are fundamentally different from all currently available
commented Shawn Singh, Chief
Executive Officer of VistaGen.
Financial Results for the Fiscal Quarter Ended December 31,
Net loss attributable to common stockholders for the fiscal quarter
ended December 31, 2017 was approximately $3.5 million, compared to
$2.9 million for the fiscal quarter ended December 31,
Research and development expense totaled approximately $1.6 million
for the fiscal quarter ended December 31, 2017, compared with
approximately $1.6 million for the fiscal quarter ended December
31, 2016. Research and development expense was primarily
attributable to the Company's development of AV-101, its oral, new
generation CNS drug candidate initially focused on displacing
adjunctive atypical antipsychotics in the current Major Depressive
Disorder (MDD) treatment paradigm, including final preparations to
launch its AV-101 MDD Phase 2 adjunctive treatment study in
patients with an inadequate response to standard FDA-approved
General and administrative expense was approximately $1.3 million
in the fiscal quarter ended December 31, 2017, compared to
approximately $2.3 million in the fiscal quarter ended December 31,
2016. The decrease was primarily attributable to decreased
professional services expenses, a decrease in noncash expense
attributable to grants of common stock for services, and a decrease
in noncash warrant modification expense, partially offset by
increased salary and benefits and noncash stock compensation
At December 31, 2017, the Company had cash and cash equivalents of
approximately $13.0 million, compared to approximately $2.9 million
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other 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 MDD. AV-101's mechanism of
action is fundamentally different 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
small 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 an
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard University is the Principal Investigator
of the VistaGen's AV-101 MDD 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,
Parkinson's disease levodopa-induced dyskinesia (PD LID) and
other CNS diseases and disorders where modulation of the NMDA
receptors, activation of AMPA pathways and/or key active
metabolites of AV-101 may achieve therapeutic benefit.
more information, please visit www.vistagen.com
and connect with VistaGen on:
Forward-Looking Statements
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 launch, continuation and results of the NIMH's
Phase 2 (MDD monotherapy) and/or the Company's planned Phase
2 (MDD adjunctive treatment) clinical studies of AV-101, allowance
of patent applications and continued protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the AV-101 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.
Pinto / Allison Soss
Strategic Communications
+1 (212) 896-1254/+1 (212) 896-1267
| VISTAGEN THERAPEUTICS | ||
| Condensed Consolidated Balance Sheets | ||
| Amounts in Dollars | ||
| December 31, | March 31, | |
| 2017 | 2017 | |
| (Unaudited) | ||
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 13,031,800 | $ 2,921,300 |
| Prepaid expenses and other current assets | 940,400 | 456,600 |
| Total current assets | 13,972,200 | 3,377,900 |
| Property and equipment, net | 222,800 | 286,500 |
| Security deposits and other assets | 47,800 | 47,800 |
| Total assets | $ 14,242,800 | $ 3,712,200 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 509,300 | $ 867,300 |
| Accrued expenses | 770,900 | 443,000 |
| Current notes payable | 43,700 | 54,800 |
| Capital lease obligations | 2,600 | 2,400 |
| Total current liabilities | 1,326,500 | 1,367,500 |
| Non-current liabilities: | ||
| Accrued dividends on Series B Preferred Stock | 2,344,400 | 1,577,800 |
| Deferred rent liability | 299,100 | 139,200 |
| Capital lease obligations | 10,000 | 11,900 |
| Total non-current liabilities | 2,653,500 | 1,728,900 |
| Total liabilities | 3,980,000 | 3,096,400 |
| Commitments and contingencies | ||
| Stockholders' equity: | ||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2017 and March 31, 2017: | ||
| Series A Preferred, 500,000 shares authorized, issued and outstanding at December 31, 2017 and March 31, 2017 | 500 | 500 |
| Series B Preferred; 4,000,000 shares authorized at December 31, 2017 and March 31, 2017; 1,160,240 | ||
| shares issued and outstanding at December 31, 2017 and March 31, 2017 | 1,200 | 1,200 |
| Series C Preferred; 3,000,000 shares authorized at December 31, 2017 and March 31, 2017; | ||
| 2,318,012 shares issued and outstanding at December 31, 2017 and March 31, 2017 | 2,300 | 2,300 |
| Common stock, $0.001 par value; 100,000,000 and 30,000,000 shares authorized at December 31, 2017 and | ||
| March 31, 2017, respectively; 22,723,504 and 8,974,386 shares issued and outstanding at December 31, 2017 | ||
| and March 31, 2017, respectively | 22,700 | 9,000 |
| Additional paid-in capital | 166,669,200 | 146,569,600 |
| Treasury stock, at cost, 135,665 shares of common stock held at December 31, 2017 and March 31, 2017 | (3,968,100 ) | (3,968,100 ) |
| Accumulated deficit | (152,465,000 ) | (141,998,700 ) |
| Total stockholders' equity | 10,262,800 | 615,800 |
| Total liabilities and stockholders' equity | $ 14,242,800 | $ 3,712,200 |
| VISTAGEN THERAPEUTICS | ||||
| STATEMENT OF OPERATIONS | ||||
| Amounts in Dollars, except share amounts | ||||
| UNAUDITED | ||||
| Three Months Ended December 31, | Nine Months Ended December 31, | |||
| 2017 | 2016 | 2017 | 2016 | |
| Revenues: | ||||
| Sublicense revenue | $ - | $ 1,250,000 | $ - | $ 1,250,000 |
| Total revenues | - | 1,250,000 | - | 1,250,000 |
| Operating expenses: | ||||
| Research and development | 1,601,800 | 1,611,000 | 5,124,600 | 4,042,800 |
| General and administrative | 1,266,000 | 2,276,600 | 4,997,400 | 4,907,800 |
| Total operating expenses | 2,867,800 | 3,887,600 | 10,122,000 | 8,950,600 |
| Loss from operations | (2,867,800 ) | (2,637,600 ) | (10,122,000 ) | (7,700,600 ) |
| Other expenses, net: | ||||
| Interest expense, net | (2,000 ) | (900 ) | (7,700 ) | (3,700 ) |
| Loss on extinguishment of accounts payable | (135,000 ) | - | (135,000 ) | - |
| Loss before income taxes | (3,004,800 ) | (2,638,500 ) | (10,264,700 ) | (7,704,300 ) |
| Income taxes | - | - | (2,400 ) | (2,400 ) |
| Net loss and comprehensive loss | (3,004,800 ) | (2,638,500 ) | (10,267,100 ) | (7,706,700 ) |
| Accrued dividend on Series B Preferred stock | (263,000 ) | (237,700 ) | (766,600 ) | (1,018,500 ) |
| Deemed dividend from trigger of down round | ||||
| provision feature | (199,200 ) | - | (199,200 ) | - |
| Deemed dividend on Series B Preferred Units | - | - | - | (111,100 ) |
| Net loss attributable to common stockholders | $ (3,467,000 ) | $ (2,876,200 ) | $ (11,232,900 ) | $ (8,836,300 ) |
| Basic and diluted net loss attributable to common | ||||
| stockholders per common share | $ (0.25 ) | $ (0.34 ) | $ (1.03 ) | $ (1.23 ) |
| Weighted average shares used in computing basic | ||||
| and diluted net loss attributable to common | ||||
| stockholders per common share | 13,895,642 | 8,381,824 | 10,947,556 | 7,181,307 |