VistaGen Therapeutics Reports Fiscal Year 2022 Second Quarter Financial Results and Provides Corporate Update
PALISADE Phase 3 clinical trials of PH94B for rapid-onset acute treatment of anxiety in adults with social anxiety disorder (SAD) progressing on plan
PH94B Phase 2A clinical program targeting additional potential anxiety indications launched in adjustment disorder with anxiety (AjDA)
Newly appointed Directors add mental health, consumer engagement expertise to the Company’s Board
“We continued our strong performance throughout the quarter with notable advances in all programs for our lead product candidate, PH94B. We advanced our PALISADE Phase 3 Program in social anxiety disorder with the initiation of a second Phase 3 study, PALISADE-2, and our PALISADE Long-term Safety Study,” said
“These milestones are encouraging advances in our focused efforts to develop and commercialize PH94B, first and foremost for the acute treatment of anxiety in adults with social anxiety disorder, if our PALISADE Phase 3 Program is successful, and ultimately for anxiety indications beyond SAD,” added
PH94B Clinical Updates
During the quarter, VistaGen initiated PALISADE-2, the second Phase 3 trial in its PALISADE Phase 3
The Company expects topline data for PALISADE-1 in mid-2022 and PALISADE-2 topline data in the second half of 2022. The Company’s PALISADE Phase 3 Program, if successful, is designed to provide the data required to support a potential submission of a PH94B
VistaGen launched its exploratory Phase 2A clinical program for PH94B, designed to evaluate its therapeutic potential in several additional anxiety disorders beyond SAD. The first study in this program is a Phase 2A clinical trial evaluating PH94B in adults experiencing adjustment disorder with anxiety (AjDA), with topline results anticipated in the second half of 2022. The Company intends to expand the PH94B Phase 2A program in 2022 to include additional exploratory studies in other anxiety indications. PH94B has potential as a novel therapeutic for postpartum anxiety, post-traumatic stress disorder, and procedural anxiety.
New data from a preclinical study of radiolabeled PH94B in animal models demonstrated that PH94B’s mechanism of action (MOA) involves binding to peripheral neurons in the nasal passages, thereby limiting the transport of molecules to the circulatory system and minimizing potential systemic exposure. These data support the fundamental differentiation of PH94B’s MOA compared to that of currently marketed therapies for anxiety disorders, including antidepressants, benzodiazepines and beta blockers, all of which require systemic uptake and distribution and are associated with potential negative side effects and safety concerns.
Additional Corporate & Pipeline Updates
VistaGen expanded the expertise of its Board of Directors with the additions of
To advance beyond successful exploratory Phase 2A clinical development of PH10 nasal spray for treatment of major depressive disorder (MDD), VistaGen is currently preparing regulatory submissions necessary to initiate a
VistaGen remains on track to initiate a Phase 1B clinical study to evaluate AV-101 in combination with probenecid during the current quarter. The FDA has granted Fast Track designation for development of AV-101 as a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain. AV-101 also has the potential to be developed as a treatment for levodopa-induced dyskinesia associated with Parkinson’s disease therapy, suicidal ideation, epilepsy, and other neurological disorders involving the NMDA (N-methyl-D-aspartate) receptor.
Fiscal Year 2022 Second Quarter Financial Results
Revenue: During the quarter ended
Research and development (R&D) expense: Research and development expense increased by
General and administrative (G&A) expense: General and administrative expense increased to approximately
Net loss: Net loss for the quarters ended
Cash position: At
At
Conference Call
VistaGen will host a conference call and live audio webcast this afternoon,
International Dial-in Number (Toll): 1-201-493-6779
Conference ID: 13724394
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1505931&tp_key=4eabb07e30
A telephone playback of the conference call will be available after approximately 8:00 p.m. Eastern Time on November 10, 2021. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13724394.
About VistaGen
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by VistaGen and its management, are inherently uncertain. The Company’s actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties relating to delays in launching and/or conducting planned clinical trials, including delays due to the impact of the ongoing COVID-19 pandemic; fluctuating costs of materials and other resources required to conduct the Company’s planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in
VistaGen Company Contacts
Media:
Vice President, Corporate Development
Phone: (650) 577-3606
Email: markmcp@vistagen.com
Phone: (615) 414-8668
Email: ChristyCurran@sambrown.com
Investors:
Vice President, Investor Relations
Phone: (650) 577-3617
Email: mflather@vistagen.com
CONSOLIDATED BALANCE SHEETS | |||||||||
(Amounts in dollars, except share amounts) | |||||||||
2021 | 2021 | ||||||||
(unaudited) | |||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 93,627,100 | $ | 103,108,300 | |||||
Receivable from collaboration partner | - | 40,600 | |||||||
Prepaid expenses and other current assets | 2,676,800 | 835,100 | |||||||
Deferred contract acquisition costs - current portion | 133,500 | 133,500 | |||||||
Total current assets | 96,437,400 | 104,117,500 | |||||||
Property and equipment, net | 496,600 | 367,400 | |||||||
Right of use asset - operating lease | 3,029,100 | 3,219,600 | |||||||
Deferred offering costs | 321,600 | 294,900 | |||||||
Deferred contract acquisition costs - non-current portion | 167,200 | 234,100 | |||||||
Security deposits | 47,800 | 47,800 | |||||||
Total assets | $ | 100,499,700 | $ | 108,281,300 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 2,659,600 | $ | 838,300 | |||||
Accrued expenses | 3,430,100 | 1,562,700 | |||||||
Deferred revenue - current portion | 1,420,200 | 1,420,200 | |||||||
Operating lease obligation - current portion | 401,000 | 364,800 | |||||||
Financing lease obligation - current portion | 1,300 | 3,000 | |||||||
Total current liabilities | 7,912,200 | 4,189,000 | |||||||
Non-current liabilities: | |||||||||
Accrued dividends on Series B Preferred Stock | 7,009,700 | 6,272,700 | |||||||
Deferred revenue - non-current portion | 1,778,200 | 2,490,300 | |||||||
Operating lease obligation - non-current portion | 3,139,900 | 3,350,800 | |||||||
Total non-current liabilities | 11,927,800 | 12,113,800 | |||||||
Total liabilities | 19,840,000 | 16,302,800 | |||||||
Commitments and contingencies | |||||||||
Stockholders’ equity: | |||||||||
Preferred stock, |
|||||||||
Series A Preferred, 500,000 shares authorized, issued and outstanding at |
500 | 500 | |||||||
Series B Preferred; 4,000,000 shares authorized at |
|||||||||
issued and outstanding at |
1,100 | 1,100 | |||||||
Series C Preferred; 3,000,000 shares authorized at |
|||||||||
issued and outstanding at |
2,300 | 2,300 | |||||||
Series D Preferred; 2,000,000 shares authorized at |
|||||||||
shares issued and outstanding at |
- | 400 | |||||||
Common stock, |
|||||||||
and 180,751,234 shares issued at |
196,500 | 180,800 | |||||||
Additional paid-in capital | 324,808,000 | 315,603,100 | |||||||
(3,968,100 | ) | (3,968,100 | ) | ||||||
Accumulated deficit | (240,380,600 | ) | (219,841,600 | ) | |||||
Total stockholders’ equity | 80,659,700 | 91,978,500 | |||||||
Total liabilities and stockholders’ equity | $ | 100,499,700 | $ | 108,281,300 | |||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS | |||||||||||||||
(Amounts in Dollars, except share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Sublicense revenue | $ | 358,000 | $ | 334,000 | $ | 712,100 | $ | 334,000 | |||||||
Total revenues | 358,000 | 334,000 | 712,100 | 334,000 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 10,066,700 | 2,358,200 | 15,670,300 | 4,089,400 | |||||||||||
General and administrative | 3,090,800 | 1,269,500 | 5,587,500 | 2,660,100 | |||||||||||
Total operating expenses | 13,157,500 | 3,627,700 | 21,257,800 | 6,749,500 | |||||||||||
Loss from operations | (12,799,500 | ) | (3,293,700 | ) | (20,545,700 | ) | (6,415,500 | ) | |||||||
Other income (expenses), net: | |||||||||||||||
Interest income (expense), net | 5,100 | (3,900 | ) | 10,200 | (7,100 | ) | |||||||||
Other income | - | - | - | 600 | |||||||||||
Loss before income taxes | (12,794,400 | ) | (3,297,600 | ) | (20,535,500 | ) | (6,422,000 | ) | |||||||
Income taxes | - | (200 | ) | (3,400 | ) | (2,600 | ) | ||||||||
Net loss and comprehensive loss | $ | (12,794,400 | ) | $ | (3,297,800 | ) | (20,538,900 | ) | (6,424,600 | ) | |||||
Accrued dividends on Series B Preferred stock | (375,200 | ) | (347,200 | ) | (737,000 | ) | (683,000 | ) | |||||||
Net loss attributable to common stockholders | $ | (13,169,600 | ) | $ | (3,645,000 | ) | $ | (21,275,900 | ) | $ | (7,107,600 | ) | |||
Basic and diluted net loss attributable to common | |||||||||||||||
stockholders per common share | $ | (0.07 | ) | $ | (0.05 | ) | $ | (0.11 | ) | $ | (0.12 | ) | |||
Weighted average shares used in computing | |||||||||||||||
basic and diluted net loss attributable to common | |||||||||||||||
stockholders per common share | 193,227,841 | 67,082,935 | 191,585,026 | 59,245,209 | |||||||||||
Source: VistaGen Therapeutics, Inc.