Vistagen Reports Fiscal 2024 Third Quarter Financial Results and Provides Corporate Update
Fasedienol PALISADE Phase 3 program for the acute treatment of social anxiety disorder remains on track
PALISADE-3 trial initiation anticipated in 1H 2024; PALISADE-4 trial initiation anticipated in 2H 2024
"Momentum from clinical and corporate milestones achieved through the end of last quarter have significantly advanced our efforts to develop and commercialize fasedienol as a potential first-in-class acute treatment for adults with social anxiety disorder. Building on the positive results of our PALISADE-2 Phase 3 trial in SAD, we remain on track to initiate our PALISADE-3 Phase 3 trial in SAD during the first half of this year," said Shawn Singh, Chief Executive Officer of Vistagen. "In parallel, we continue to make significant progress toward Phase 2B development of two additional clinical-stage neuroscience assets in our pipeline, itruvone for major depressive disorder and hormone-free PH80 for women's health indications, including vasomotor symptoms (hot flashes) due to menopause."
Fasedienol Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)
To complement Vistagen’s successful PALISADE-2 Phase 3 trial of fasedienol for the acute treatment of SAD, the Company’s PALISADE-3 trial, anticipated to initiate during the first half of 2024, as well as its PALISADE-4 trial, which is anticipated to be initiated in the second half of 2024, will be
Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol
Itruvone Nasal Spray for Major Depressive Disorder (MDD)
Leveraging a successful exploratory Phase 2A trial of itruvone for the treatment of MDD, preparations and planning are underway for Phase 2B development.
PH80 Nasal Spray for Vasomotor Symptoms (Hot Flashes) due to Menopause and other Women’s Health Indications
Expanding upon successful exploratory Phase 2A trials of PH80 in two women’s health indications, preparations and planning are underway for
Fiscal Year 2024 Third Quarter Financial Results
Research and development (R&D) expense: R&D expense was
General and administrative (G&A) expense: G&A expense was
Net loss: Net loss was
Cash position: At December 31, 2023, the Company had cash and cash equivalents of approximately
As of February 12, 2024, the Company had 27,029,731 shares of common stock issued and 3,577,240 pre-funded warrants outstanding.
Conference Call:
Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update.
International Dial-in Number (Toll): 1-201-493-6779
Conference ID: 13743176
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1648110&tp_key=097d964c22
A live audio conference call webcast will also be available via the above link. 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 8:00 p.m. Eastern Time on Tuesday, February 13, 2024. To listen to the replay, call toll-free 1-844-512-2921 within
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders. Five of Vistagen’s six clinical-stage product candidates belong to a new class of drugs known as pherines, which have the potential to rapidly deliver meaningful efficacy with a differentiated safety profile. Pherines are investigational neuroactive nasal sprays with innovative proposed mechanisms of action that activate chemosensory neurons in the nasal passages to impact fundamental neural circuits in the brain without the need for systemic absorption or binding to receptors in the brain. Vistagen’s sixth clinical-stage product candidate, AV-101, is an investigational oral drug candidate with the potential to inhibit, but not block, NMDA receptor activity. Vistagen is passionate about transforming what is possible in the treatment of anxiety, depression, and other neuroscience disorders. 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 all 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 drug candidates will successfully complete ongoing or, if initiated, future clinical trials, receive regulatory approval or be commercially successful, or that the Company will be able to successfully replicate the result of past studies of its product candidates, including fasedienol, itruvone, PH80 or its other drug candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the Company’s submission of an
VISTAGEN THERAPEUTICS, INC. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
|
|||||||
December 31, | March 31, | ||||||
2023 |
2023 |
||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ |
126,559,200 |
|
$ |
16,637,600 |
|
|
Prepaid expenses and other current assets |
|
1,480,300 |
|
|
802,700 |
|
|
Deferred contract acquisition costs - current portion |
|
74,500 |
|
|
67,100 |
|
|
Total current assets |
|
128,114,000 |
|
|
17,507,400 |
|
|
Property and equipment, net |
|
445,100 |
|
|
507,300 |
|
|
Right-of-use asset - operating lease |
|
1,933,600 |
|
|
2,260,300 |
|
|
Deferred offering costs |
|
325,700 |
|
|
495,700 |
|
|
Deferred contract acquisition costs - non-current portion |
|
148,700 |
|
|
217,600 |
|
|
Security deposits |
|
100,900 |
|
|
100,900 |
|
|
Total assets | $ |
131,068,000 |
|
$ |
21,089,200 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ |
1,737,000 |
|
$ |
2,473,100 |
|
|
Accrued expenses |
|
129,300 |
|
|
787,400 |
|
|
Note payable |
|
- |
|
|
105,300 |
|
|
Deferred revenue - current portion |
|
1,762,800 |
|
|
714,300 |
|
|
Operating lease obligation - current portion |
|
533,500 |
|
|
485,600 |
|
|
Financing lease obligation - current portion |
|
1,900 |
|
|
1,700 |
|
|
Total current liabilities |
|
4,164,500 |
|
|
4,567,400 |
|
|
Deferred revenue - non-current portion |
|
1,899,400 |
|
|
2,314,600 |
|
|
Operating lease obligation - non-current portion |
|
1,713,300 |
|
|
2,119,800 |
|
|
Financing lease obligation - non-current portion |
|
6,000 |
|
|
7,400 |
|
|
Total liabilities |
|
7,783,200 |
|
|
9,009,200 |
|
|
Commitments and contingencies (Note 10) | |||||||
Stockholders’ equity: | |||||||
Preferred stock, no shares outstanding at December 31, 2023 and March 31, 2023 |
|
- |
|
|
- |
|
|
Common stock, 27,029,731 and 7,315,583 shares issued at December 31, 2023 and March 31, 2023, respectively |
|
27,000 |
|
|
7,300 |
|
|
Additional paid-in capital |
|
473,918,200 |
|
|
342,892,500 |
|
|
Treasury stock, at cost, 4,522 shares of common stock held at December 31, 2023 and March 31, 2023 |
|
(3,968,100 |
) |
|
(3,968,100 |
) |
|
Accumulated deficit |
|
(346,692,300 |
) |
|
(326,851,700 |
) |
|
Total stockholders’ equity |
|
123,284,800 |
|
|
12,080,000 |
|
|
Total liabilities and stockholders’ equity | $ |
131,068,000 |
|
$ |
21,089,200 |
|
VISTAGEN THERAPEUTICS | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS | |||||||||||||||
(Unaudited) | |||||||||||||||
|
|||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||
Revenues: | |||||||||||||||
Sublicense and other revenue | $ |
411,400 |
|
$ |
179,600 |
|
$ |
866,700 |
|
$ |
(402,900 |
) |
|||
Total revenues |
|
411,400 |
|
|
179,600 |
|
|
866,700 |
|
|
(402,900 |
) |
|||
Operating expenses: | |||||||||||||||
Research and development |
|
4,537,600 |
|
|
6,854,000 |
|
|
12,585,400 |
|
|
35,039,800 |
|
|||
General and administrative |
|
3,757,800 |
|
|
3,092,100 |
|
|
9,943,300 |
|
|
11,586,200 |
|
|||
Total operating expenses |
|
8,295,400 |
|
|
9,946,100 |
|
|
22,528,700 |
|
|
46,626,000 |
|
|||
Loss from operations |
|
(7,884,000 |
) |
|
(9,766,500 |
) |
|
(21,662,000 |
) |
|
(47,028,900 |
) |
|||
Other income, net: | |||||||||||||||
Interest income, net |
|
1,534,200 |
|
|
5,300 |
|
|
1,823,900 |
|
|
13,700 |
|
|||
Loss before income taxes |
|
(6,349,800 |
) |
|
(9,761,200 |
) |
|
(19,838,100 |
) |
|
(47,015,200 |
) |
|||
Income taxes |
|
- |
|
|
- |
|
|
(2,500 |
) |
|
(5,500 |
) |
|||
Net loss and comprehensive loss | $ |
(6,349,800 |
) |
$ |
(9,761,200 |
) |
$ |
(19,840,600 |
) |
$ |
(47,020,700 |
) |
|||
Basic and diluted net loss per common share | $ |
(0.22 |
) |
$ |
(1.42 |
) |
$ |
(1.27 |
) |
$ |
(6.82 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
29,388,085 |
|
|
6,894,603 |
|
|
15,632,451 |
|
|
6,891,641 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240213784404/en/
Investors Inquiries:
Mark A. McPartland
(650) 577-3606
markmcp@vistagen.com
Media Inquiries:
Caren Scannell
(650) 577-3601
cscannell@vistagen.com
Source: Vistagen