VistaGen Therapeutics Reports First Quarter Financial Results and Provides Corporate Update
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) reported its Q1 fiscal 2023 results, pausing enrollment in PALISADE-2 and conducting an interim analysis following PALISADE-1's failure to meet primary efficacy endpoints for PH94B in treating social anxiety disorder (SAD). However, preliminary data from nearly 200 subjects indicate potential cumulative functional improvement with PH94B. R&D expenses rose to $15.3 million, while G&A expenses increased to $4.8 million, leading to a net loss of $19.8 million. The company has $52 million in cash, anticipating a reduction in external spending to extend its cash runway.
- Preliminary data suggest PH94B may provide cumulative improvement in SAD symptoms.
- PH94B's safety profile remains favorable with no severe adverse events reported.
- Cash reserves of approximately $52 million expected to cover the next 12 months.
- PALISADE-1 Phase 3 study did not meet primary efficacy endpoint.
- Significant increase in R&D expenses by $9.8 million compared to last year.
- Net loss increased to approximately $19.8 million for this quarter.
Evaluation of PALISADE-1 continues and interim analysis of PALISADE-2 begins
Preliminary data from nearly 200 subjects in the PALISADE open label safety study suggest that continued as-needed use of PH94B has potential to achieve cumulative functional improvement in the severity of social anxiety disorder (SAD)
“We remain steadfast in our commitment to change the trajectory of mental health care for millions of people affected by anxiety and depression disorders,” said
“We continue to believe in PH94B’s potential to help individuals suffering from social anxiety disorder. We are further encouraged by preliminary data from a cohort of nearly 200 patients in our PALISADE open label safety study who have completed three months of acute, as-needed use of PH94B. These preliminary data suggest that repeated acute, as-needed use of PH94B over an extended period of time has potential to increasingly relieve symptoms of social anxiety disorder, as measured by the Liebowitz Social Anxiety Scale, or LSAS, which historically has been the diagnostic gold standard for clinical assessment of social anxiety disorder. Taken together with encouraging published results from a prior Phase 2 study in social anxiety disorder which involved multiple administration assessment of PH94B over a two-week period measured by the LSAS, these preliminary data support the published findings and give us confidence in PH94B’s potential to reduce the severity of social anxiety on an acute, as-needed basis, while also achieving cumulative improvement in everyday social functioning, with continued use in a real-world environment.”
“Having deferred a large portion of our NDA-enabling activities, we have reduced our expected cash requirements for our operations over the next year. Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal,” added Singh.
First Quarter Fiscal Year 2023 & Recent Business Highlights
Below is an update on the Company’s pipeline of CNS product candidates— the nasal spray, pherine-based platform consisting of PH94B and PH10, and our NMDA (N-methyl-D-aspartate) receptor program, involving orally available AV-101.
Although PALISADE-1 did not meet its primary efficacy endpoint, the tolerability of PH94B in PALISADE-1 was favorable and consistent with reported results from previous clinical trials. No severe or serious adverse events were reported for PH94B in PALISADE-1 or in other clinical trials.
In addition, the Company is encouraged by preliminary data from a cohort of nearly 200 subject in its PALISADE open label safety study which suggest an excellent safety profile for PH94B consistent with all previous studies, as well as cumulative functional improvement as measured by the Liebowitz Social Anxiety Scale (LSAS). In this study, which mirrors real world use, this cohort of study participants has used PH94B acutely, as-needed, multiple times for three months. Given these data, along with positive indications from the prior Phase 2 studies, the Company believes that continued Phase 3 clinical development of PH94B as a potential treatment for SAD is appropriate, particularly with repeated and longer-term use of PH94B evaluated by multiple administration assessments using the LSAS as the primary endpoint and SUDS as the secondary endpoint.
The Company is evaluating potential study design modifications in its PALISADE Phase 3 program, including an extended exposure period, and is preparing to meet with the FDA to discuss potential next steps for the late-stage clinical development of PH94B.
Phase 2 Trial of PH94B in Adjustment Disorder with Anxiety and Future Opportunities – The Company has an ongoing exploratory Phase 2A clinical trial designed to evaluate the efficacy, safety and tolerability of PH94B as a potential treatment of adults with adjustment disorder with anxiety (AjDA). The study protocol involves multiple administration assessments of PH94B, which is administered four times per day for 28 days. We anticipate topline data from this AjDA trial in late 2022.
PH10 Nasal Spray Development Continues for Multiple Depression Disorders – Following positive results from an exploratory Phase 2A study of PH10 in major depressive disorder (MDD) conducted in
AV-101 + Probenecid Phase 1B Trial Progressing – Following positive preclinical data, VistaGen initiated a Phase 1B drug-drug interaction study of AV-101 in combination with probenecid in late 2021. The Company is considering the evaluation of AV-101 in combination with probenecid as a potential oral treatment for several distinct neurological disorders.
Fiscal Year 2023 First Quarter Financial Results
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 attributable to common stockholders for the fiscal quarters ended
Cash position: At
As a result of the deferral of several research and development and pre-commercial activities involving PH94B, the Company anticipates a considerable reduction in external spending to conserve cash and extend the Company’s cash runway covering at least the next 12 months.
As of
Conference Call
VistaGen will host a conference call and live audio webcast this afternoon at
International Dial-in Number (Toll): 1-848-280-6460
Conference ID: 4956626
Webcast Link: https://viavid.webcasts.com/starthere.jsp?ei=1558823&tp_key=7de8cd8f64
A live audio webcast of the conference call will also be available via the link provided above. Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately
About VistaGen
VistaGen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused biopharmaceutical company striving to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The Company is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available. VistaGen’s clinical-stage candidates are targeting multiple forms of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are odorless and tasteless investigational neuroactive steroids designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. Connect at www.VistaGen.com.
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. As with any pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that any of the Company’s other drug candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the results of the Company’s interim analysis of data currently available from the PALISADE-2 Phase 3 clinical trial; the completion and results of the Company’s ongoing clinical studies of PH94B, including the Company’s Phase 2A clinical trial of PH94B in adults experiencing adjustment disorder with anxiety, and ongoing studies of the Company’s other product candidates, PH10 and AV-101; delays in launching, conducting and/or completing other ongoing and planned clinical trials, including delays or other adverse effects due to the impact of the ongoing COVID-19 pandemic; fluctuating costs of materials and other resources required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (Amounts in dollars, except share amounts) | ||||||||
|
2022 |
|
|
2022 |
|
|||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
51,986,400 |
|
$ |
68,135,300 |
|
||
| Prepaid expenses and other current assets |
|
2,890,300 |
|
|
2,745,800 |
|
||
| Deferred contract acquisition costs - current portion |
|
116,900 |
|
|
116,900 |
|
||
| Total current assets |
|
54,993,600 |
|
|
70,998,000 |
|
||
| Property and equipment, net |
|
567,600 |
|
|
414,300 |
|
||
| Right-of-use asset - operating lease |
|
2,565,000 |
|
|
2,662,000 |
|
||
| Deferred offering costs |
|
381,200 |
|
|
321,800 |
|
||
| Deferred contract acquisition costs - non-current portion |
|
117,300 |
|
|
146,400 |
|
||
| Security deposits |
|
100,900 |
|
|
100,900 |
|
||
| Total assets | $ |
58,725,600 |
|
$ |
74,643,400 |
|
||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
5,473,000 |
|
$ |
2,758,600 |
|
||
| Accrued expenses |
|
727,300 |
|
|
1,329,200 |
|
||
| Notes payable |
|
1,037,800 |
|
|
- |
|
||
| Deferred revenue - current portion |
|
1,244,000 |
|
|
1,244,000 |
|
||
| Operating lease obligation - current portion |
|
442,600 |
|
|
433,300 |
|
||
| Financing lease obligation - current portion |
|
1,500 |
|
|
- |
|
||
| Total current liabilities |
|
8,926,200 |
|
|
5,765,100 |
|
||
| Non-current liabilities: | ||||||||
| Deferred revenue - non-current portion |
|
1,247,500 |
|
|
1,557,600 |
|
||
| Operating lease obligation - non-current portion |
|
2,491,200 |
|
|
2,605,400 |
|
||
|
8,700 |
|
|
- |
|
|||
| Total non-current liabilities |
|
3,747,400 |
|
|
4,163,000 |
|
||
| Total liabilities |
|
12,673,600 |
|
|
9,928,100 |
|
||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, |
||||||||
| Common stock, |
206,900 |
206,700 |
||||||
| Additional paid-in capital |
|
337,193,500 |
|
|
336,080,700 |
|
||
|
(3,968,100 |
) |
|
(3,968,100 |
) |
|||
| Accumulated deficit |
|
(287,380,300 |
) |
|
(267,604,000 |
) |
||
| Total stockholders’ equity |
|
46,052,000 |
|
|
64,715,300 |
|
||
| Total liabilities and stockholders’ equity | $ |
58,725,600 |
|
$ |
74,643,400 |
|
||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS | ||||||||
| (Unaudited) | ||||||||
| (Amounts in Dollars, except share amounts) | ||||||||
| Three Months Ended |
||||||||
|
2022 |
|
|
2021 |
|
|||
| Revenues: | ||||||||
| Sublicense revenue | $ |
310,100 |
|
$ |
354,100 |
|
||
| Total revenues |
|
310,100 |
|
|
354,100 |
|
||
| Operating expenses: | ||||||||
| Research and development | $ |
15,291,400 |
|
$ |
5,457,200 |
|
||
| General and administrative |
|
4,791,800 |
|
|
2,643,100 |
|
||
| Total operating expenses |
|
20,083,200 |
|
|
8,100,300 |
|
||
| Loss from operations |
|
(19,773,100 |
) |
|
(7,746,200 |
) |
||
| Other income, net: | ||||||||
| Interest income, net |
|
2,300 |
|
|
5,100 |
|
||
| Loss before income taxes |
|
(19,770,800 |
) |
|
(7,741,100 |
) |
||
| Income taxes |
|
(5,500 |
) |
|
(3,400 |
) |
||
| Net loss and comprehensive loss | $ |
(19,776,300 |
) |
$ |
(7,744,500 |
) |
||
| Accrued dividend on Series B Preferred stock |
|
- |
|
|
(361,800 |
) |
||
| Net loss attributable to common stockholders | $ |
(19,776,300 |
) |
$ |
(8,106,300 |
) |
||
| Basic and diluted net loss attributable to common stockholders per common share | $ |
(0.10 |
) |
$ |
(0.04 |
) |
||
| Weighted average shares used in computing basic and diluted net loss attributable to common stockholders per common share |
|
206,596,724 |
|
|
189,924,158 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005677/en/
Investors:
Vice President, Investor Relations
(650) 577-3617
mflather@vistagen.com
Media:
SKDK
nhitchings@skdknick.com
Source:
FAQ
What were the financial results for VistaGen (VTGN) in Q1 fiscal 2023?
What is the status of the PALISADE clinical studies for PH94B?
What does the preliminary data from the PALISADE safety study indicate?
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What changes are anticipated for VistaGen’s research and development activities?
