Vistagen Reports Fiscal Year 2024 Financial Results and Provides Corporate Update
Vistagen (Nasdaq: VTGN) reported its fiscal year 2024 financial results, showcasing significant progress in its clinical programs. The company highlighted positive results from the PALISADE-2 Phase 3 trial of fasedienol for social anxiety disorder (SAD), with PALISADE-3 initiated and PALISADE-4 set to start in 2H 2024. Additionally, itruvone for major depressive disorder (MDD) and PH80 for menopausal hot flashes showed positive Phase 1 and Phase 2A data, respectively. Financially, Vistagen's R&D expenses decreased to $20.0 million from $44.4 million, and G&A expenses slightly fell to $14.1 million from $14.7 million. The net loss was significantly reduced to $29.4 million compared to $59.2 million in the previous year. Cash and cash equivalents stood at $119.2 million as of March 31, 2024.
- Positive results from PALISADE-2 Phase 3 trial for fasedienol in social anxiety disorder.
- Initiation of PALISADE-3 Phase 3 trial and preparation for PALISADE-4 Phase 3 trial.
- Positive Phase 1 data for itruvone and Phase 2A data for PH80.
- R&D expenses decreased to $20.0 million from $44.4 million.
- Net loss significantly reduced to $29.4 million from $59.2 million.
- Cash and cash equivalents stood at $119.2 million as of March 31, 2024.
- G&A expenses only slightly decreased to $14.1 million from $14.7 million.
- The net loss still stands at $29.4 million, indicating ongoing financial challenges.
- Future clinical trials (PALISADE-4) imply continued high R&D expenditure.
Insights
It's noteworthy that Vistagen's R&D expenses decreased significantly from
The positive outcomes from the PALISADE-2 Phase 3 trial for SAD mark a significant milestone. A key point here is that Vistagen is the first to report positive Phase 3 results for an acute treatment of SAD—a condition with high unmet medical need as there are no FDA-approved acute treatments currently available. The initiation of PALISADE-3 and PLANNED PALISADE-4 trials indicates a robust clinical development pipeline and if these trials replicate the success of PALISADE-2, it could support a strong case for an NDA submission. The unique mechanism of action (MOA) of fasedienol, which is non-systemic and acts via nasal administration, could offer a safer alternative to current systemic treatments. This differentiation might make it appealing to both doctors and patients seeking innovative treatment options with potentially lower side effects.
Vistagen's exclusive negotiation agreement with Fuji Pharma, focusing on the commercialization of PH80 in Japan for menopausal hot flashes, opens new market opportunities. Japan's pharmaceutical market is one of the largest globally and successful commercialization could significantly boost Vistagen's revenue streams. The underwritten public offering that closed in the third quarter of fiscal 2024 has provided the company with the necessary capital to execute its key milestones. This financial buffer is essential for the high-risk, high-reward nature of biopharmaceutical R&D. Investors should keep an eye on the progression of these international collaborations as they may lead to strategic partnerships or licensing agreements, reducing the financial burden on Vistagen while expanding their market footprint.
Registration-directed fasedienol PALISADE Phase 3 program for the acute treatment of social anxiety disorder progressing on track
PALISADE-3 Phase 3 trial recently initiated; PALISADE-4 Phase 3 trial initiation anticipated in 2H 2024
“Vistagen’s fiscal 2024 proved to be a year full of remarkable accomplishments. Most notably, with our PALISADE-2 trial of fasedienol, we became the first company to report positive results of a Phase 3 trial for the acute treatment of social anxiety disorder, a mental health disorder affecting the lives of over 30 million adults in the
Fasedienol for the Acute Treatment of Social Anxiety Disorder (SAD)
-
Reported Positive PALISADE-2 Phase 3 Trial Results. In the second quarter of fiscal 2024, Vistagen announced positive top-line results from PALISADE-2, a
U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy, safety, and tolerability of fasedienol for the acute treatment of SAD after a single dose of fasedienol during a simulated, anxiety-provoking public speaking challenge in a clinical setting, as measured using the patient-reported Subjective Units of Distress Scale (SUDS) as the primary efficacy endpoint. Fasedienol is Vistagen’s lead investigational neuroactive pherine formulated as a rapid-onset nasal spray to activate olfactory and brain neural circuits without requiring systemic uptake or binding to neurons in the brain. Fasedienol’s proposed MOA is fundamentally differentiated from the MOA of all currently approved treatments for anxiety disorders. Currently, there is no FDA-approved drug therapy for the acute treatment of SAD. With PALISADE-2, Vistagen became the first company to report a positive Phase 3 trial of a drug candidate for the acute treatment of SAD. - Initiated PALISADE-3 Phase 3 Trial; Preparation for PALISADE-4 Phase 3 Trial Underway. In the fourth quarter of fiscal 2024, Vistagen launched its PALISADE-3 Phase 3 trial of fasedienol for the acute treatment of SAD. With PALISADE-3 initiated, the Company is now preparing to launch its PALISADE-4 Phase 3 trial in the second half of calendar 2024. PALISADE-3 and PALISADE-4 are designed similarly to PALISADE-2, including an open-label extension for a period of up to 12 months with subjects able to use fasedienol up to 6 times per day in their everyday lives prior to anxiety-provoking social and performance stressors.
Itruvone for Major Depressive Disorder (MDD)
-
Completed Successful
U.S. Phase 1 Trial to EnableU.S. Phase 2B Development. In the first quarter of fiscal 2024, Vistagen announced favorable safety and tolerability data from itsU.S. Phase 1 clinical trial of itruvone to build on successful Phase 1 and Phase 2A clinical studies of itruvone previously conducted outside theU.S. Leveraging positive results from an exploratory Phase 2A trial in MDD, preparations and planning are underway forU.S. Phase 2B development of itruvone as a novel, non-systemic stand-alone treatment for MDD. - Reported Key Pherine Mechanism of Action (MOA) Data. In the second quarter of fiscal 2024, the Company reported preclinical data demonstrating that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma. Similar to previously reported preclinical MOA data of fasedienol, these new preclinical data for itruvone further support its unique proposed MOA as involving binding to receptors of peripheral chemosensory neurons in the nasal cavity, but not to neuronal receptors in the central nervous system, and thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure. Itruvone’s proposed MOA is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders.
PH80 for Women’s Health Indications
-
Announced Positive Exploratory Phase 2A Data Study for the Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause. In the first quarter of fiscal 2024, Vistagen announced positive data from a previously unreported exploratory Phase 2A clinical trial conducted outside the
U.S. in which PH80, Vistagen’s rapid-onset, hormone-free neuroactive pherine nasal spray, demonstrated statistically significant efficacy versus placebo for the treatment of vasomotor symptoms (hot flashes) due to menopause. PotentialU.S. IND-enabling studies are underway to facilitate further Phase 2 development of PH80 in theU.S. for the treatment of menopausal hot flashes. PH80’s proposed MOA is fundamentally differentiated from the MOA of all currently approved treatments for menopausal hot flashes. -
Announced Positive Exploratory Phase 2A Data Study for Treatment of Premenstrual Dysphoric Disorder (PMDD). In the second quarter of fiscal 2024, the Company announced positive data from a previously unreported exploratory Phase 2A clinical trial conducted outside the
U.S. in which PH80 demonstrated statistically significant efficacy versus placebo for the treatment of PMDD.
Corporate Updates
- In the first quarter of fiscal 2024, Vistagen was awarded Mental Health America’s Platinum Bell Seal for workplace mental health, an award the Company received again in the first quarter of fiscal 2025. Receipt of this prestigious award demonstrates Vistagen’s ongoing commitment to bringing mental health awareness and action to the forefront of its workplace and corporate objectives.
- In the second quarter of fiscal 2024, Vistagen announced the appointment of Cindy Anderson as Chief Financial Officer. Ms. Anderson brings almost two decades of financial and operating strength from her experiences in the biopharmaceutical sector.
-
In the second quarter of fiscal 2024, Vistagen entered into an Exclusive Negotiation Agreement with Fuji Pharma Co., Ltd. (Fuji Pharma), a leading company in
Japan focused on women’s health, to negotiate exclusively with Fuji Pharma for a potential agreement to develop and commercialize Vistagen’s hormone-free pherine nasal spray, PH80, inJapan for the treatment of vasomotor symptoms (hot flashes) due to menopause. - In the third quarter of fiscal 2024, Vistagen closed an underwritten public offering, providing the Company with cash runway to execute critical milestones in its registration-directed PALISADE Phase 3 program for fasedienol in SAD and across other programs in its neuroscience pipeline.
Financial Results for Fiscal Year 2024
Research and development (R&D) expenses
-
R&D expenses were
$20.0 million $44.4 million
General and administrative (G&A) expenses
-
G&A expenses were
$14.1 million $14.7 million
Net loss
-
Net loss was
$29.4 million $59.2 million
Other financial highlights
-
Cash and cash equivalents were
$119.2 million - As of June 10, 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: 13746589
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1670447&tp_key=0236806001
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, June 11, 2024. To listen to the replay, call toll-free 1-844-512-2921 within
About Vistagen
Headquartered in
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 delays in launching, conducting and/or completing ongoing and planned nonclinical studies and clinical trials, including PALISADE-3 and PALISADE-4 or additional Phase 2 clinical trials of itruvone or PH80; the period over which the Company anticipates its available financial resources will fund its operating expense; the timing of completion of preclinical studies and clinical trials and related preparatory work required to apply for an maintain regulatory approval for any of our product candidates; the scope and enforceability of the Company’s patents, including patents related to the Company’s pherine drug candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in
| VISTAGEN THERAPEUTICS, INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and par value amounts) | ||||||||
| March 31, | ||||||||
|
2024 |
|
|
2023 |
|
|||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
119,166 |
|
$ |
16,638 |
|
||
| Prepaid expenses and other current assets |
|
1,432 |
|
|
802 |
|
||
| Deferred contract acquisition costs - current portion |
|
74 |
|
|
67 |
|
||
| Total current assets |
|
120,672 |
|
|
17,507 |
|
||
| Property and equipment, net |
|
435 |
|
|
507 |
|
||
| Right-of-use asset - operating lease |
|
1,820 |
|
|
2,260 |
|
||
| Deferred offering costs |
|
495 |
|
|
496 |
|
||
| Deferred contract acquisition costs - non-current portion |
|
130 |
|
|
218 |
|
||
| Security deposits |
|
101 |
|
|
101 |
|
||
| Total assets | $ |
123,653 |
|
$ |
21,089 |
|
||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
1,547 |
|
$ |
2,473 |
|
||
| Accrued expenses |
|
2,235 |
|
|
796 |
|
||
| Note payable |
|
- |
|
|
105 |
|
||
| Deferred revenue - current portion |
|
791 |
|
|
714 |
|
||
| Operating lease obligation - current portion |
|
550 |
|
|
486 |
|
||
| Total current liabilities |
|
5,123 |
|
|
4,574 |
|
||
| Deferred revenue - non-current portion |
|
2,674 |
|
|
2,315 |
|
||
| Operating lease obligation - non-current portion |
|
1,570 |
|
|
2,120 |
|
||
| Total liabilities |
|
9,367 |
|
|
9,009 |
|
||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, |
|
- |
|
|
- |
|
||
| Common stock, |
|
27 |
|
|
7 |
|
||
| Additional paid-in capital |
|
474,441 |
|
|
342,893 |
|
||
| Treasury stock, at cost, 4,522 shares of common stock held at March 31, 2024 and March 31, 2023 |
|
(3,968 |
) |
|
(3,968 |
) |
||
| Accumulated deficit |
|
(356,214 |
) |
|
(326,852 |
) |
||
| Total stockholders’ equity |
|
114,286 |
|
|
12,080 |
|
||
| Total liabilities and stockholders’ equity | $ |
123,653 |
|
$ |
21,089 |
|
||
| VISTAGEN THERAPEUTICS | |||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
| (in thousands, except share and per share amounts) | |||||||||
| Year Ended March 31, | |||||||||
|
2024 |
|
|
2023 |
|
||||
| Revenues: | |||||||||
| Sublicense and other revenue | $ |
1,064 |
|
$ |
(227 |
) |
|||
| Total revenues |
|
1,064 |
|
|
(227 |
) |
|||
| Operating expenses: | |||||||||
| Research and development |
|
20,022 |
|
|
44,377 |
|
|||
| General and administrative |
|
14,063 |
|
|
14,664 |
|
|||
| Total operating expenses |
|
34,085 |
|
|
59,041 |
|
|||
| Loss from operations |
|
(33,021 |
) |
|
(59,268 |
) |
|||
| Other income, net: | |||||||||
| Interest income, net |
|
3,351 |
|
|
26 |
|
|||
| Other income |
|
312 |
|
|
- |
|
|||
| Loss before income taxes |
|
(29,358 |
) |
|
(59,242 |
) |
|||
| Income taxes |
|
(4 |
) |
|
(6 |
) |
|||
| Net loss and comprehensive loss | $ |
(29,362 |
) |
$ |
(59,248 |
) |
|||
| Basic and diluted net loss per common share | $ |
(1.52 |
) |
$ |
(8.51 |
) |
|||
| Weighted average common shares outstanding, basic and diluted |
|
19,354,500 |
|
|
6,958,749 |
|
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240611760116/en/
Investors:
Mark A. McPartland
Vistagen Therapeutics
markmcp@vistagen.com
Media:
Caren Scannell
Vistagen Therapeutics
cscannell@vistagen.com
Source: Vistagen
FAQ
What were the results of Vistagen's PALISADE-2 Phase 3 trial for fasedienol?
When is Vistagen planning to initiate the PALISADE-4 Phase 3 trial?
What are Vistagen's financial results for fiscal year 2024?
How much cash and cash equivalents did Vistagen have as of March 31, 2024?
What are the ongoing clinical developments at Vistagen?
