VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical
company committed to developing and commercializing a new
generation of medicines with the potential to go beyond the current
standard of care for anxiety, depression and other central nervous
system (CNS) disorders, today provided a corporate update and
reported financial results for its fiscal year ended March 31,
2021.
“Our fiscal year 2021 was transformative, involving several drug
development, financial and regulatory milestones that fortified the
foundation for our very strong start this fiscal year. Notably, we
achieved an important consensus with the U.S. Food and Drug
Administration regarding our PALISADE Phase 3 program for PH94B in
social anxiety disorder. Building on that positive meeting, we
completed a PH94B collaboration in ex-U.S. markets, strengthened
our balance sheet with substantial investment from numerous
long-biased, healthcare-focused institutional investors, and
advanced several development programs across our CNS pipeline, most
notably preparations for PALISADE-1, our U.S. multi-center Phase 3
clinical study of PH94B as a potential rapid-onset, acute treatment
of anxiety in adults with social anxiety disorder. If successful,
PALISADE-1 is designed to be among the studies necessary to support
a potential PH94B New Drug Application to the U.S. Food and Drug
Administration in 2023. We recently initiated PALISADE-1, moving us
closer to our goal of going beyond the current treatment paradigm
for social anxiety disorder, not only displacing antidepressants,
benzodiazepines and beta blockers, but also reaching those in need
of support who find those therapies to be undesirable or
inadequate. We anticipate topline data from PALISADE-1 in mid-2022.
Later this year, we expect to launch PALISADE-2, a second U.S.
multi-center Phase 3 clinical study of PH94B designed to be
substantially similar to PALISADE-1 and equally supportive of our
U.S. New Drug Application goal.”
Singh added, “During the current fiscal year, we also expect to
prepare for and initiate several exploratory Phase 2A clinical
trials of PH94B in additional anxiety disorders, advance
preparations necessary to initiate a U.S. multi-center Phase 2B
clinical trial of PH10 as a potential rapid-onset, stand-alone
treatment for major depressive disorder, and initiate a Phase 1B
clinical trial of AV-101 with probenecid, which, if successful, has
the potential to support exploratory Phase 2A development of the
combination in several CNS disorders.”
“To develop and commercialize game-changing treatments, you need
great people. During the past year, we have strengthened our team
by adding several key personnel with deep CNS drug development and
commercial experience to drive our programs through important
late-stage development milestones and appropriately-timed
pre-commercial and commercial launch operations. We look forward to
initiating several more clinical trials this fiscal year and remain
focused on pursuing our mission to improve mental health and
well-being for individuals in the U.S. and abroad,” concluded
Singh.
Corporate Highlights
- Reached consensus with U.S. Food and Drug Administration (FDA)
on key aspects of the design of Phase 3 clinical trials of PH94B
for acute treatment of anxiety in adults with SAD after a positive
meeting. The Phase 3 clinical studies of PH94B in the Company’s
PALISADE Phase 3 program will substantially mirror the public
speaking challenge in the statistically significant Phase 2 study
of PH94B, providing significant time and cost-efficiency for the
program.
- Entered into a strategic licensing and collaboration agreement
with EverInsight Therapeutics, Inc. (now AffaMed Therapeutics,
Inc.) for clinical development and commercialization of PH94B in
Greater China, South Korea and Southeast Asia (Territory), pursuant
to which VistaGen received a non-dilutive upfront payment of $5
million. VistaGen is eligible to receive additional development and
commercial milestone payments of up to $172 million and tiered
royalties on sales of PH94B in the Territory, if Phase 3
development efforts there are successful.
- Reported positive preclinical data differentiating the
mechanism of action (MOA) of PH94B and PH10 from risk-ridden
benzodiazepines, demonstrating that the MOA of PH94B and PH10 does
not involve direct activation of GABA-A receptors, in distinct
contrast to the MOA of benzodiazepines, which act as direct
positive modulators of GABA-A receptors.
- Reported positive preclinical data demonstrating the potential
of the combination of AV-101 and probenecid to substantially
increase the brain concentration of AV-101's active metabolite,
7-Cl-KYN, a potent and selective full antagonist of the NMDA
receptor glycine co-agonist site, thereby reducing, rather than
blocking, NMDA receptor signaling.
- Raised $127.5 million gross proceeds from partnering and
corporate finance transactions, including a $100
million underwritten public offering led by Jefferies Group
LLC and William Blair & Company involving significant
participation from key healthcare-focused institutional investors,
such as Acuta Capital, New Enterprise Associates, OrbiMed and
Venrock Healthcare Capital Partners.
- Appointed key senior leadership to execute corporate
initiatives through commercialization.
CNS Pipeline Updates
PH94B
PH94B is a synthetic investigational neurosteroid developed from
proprietary compounds called pherines. With its novel MOA, PH94B is
an odorless nasal spray administered at microgram-level doses to
achieve rapid-onset anti-anxiety, or anxiolytic, effects. The novel
pharmacological MOA of PH94B is fundamentally differentiated from
that of all FDA-approved anti-anxiety drugs, including all
antidepressants approved by the FDA for treatment of SAD, as well
as all benzodiazepines and beta blockers prescribed on an off-label
basis. PH94B engages peripheral chemosensory receptors in nasal
passages that trigger a subset of neurons in the main olfactory
bulbs (OB) at the base of the brain. The OB neurons then
stimulate inhibitory GABAergic neurons in the limbic amygdala,
decreasing the activity of the sympathetic nervous system, and
facilitating fear extinction activity of the limbic-hypothalamic
system, the main fear and anxiety center in the brain, as well as
in other parts of the brain. Importantly, PH94B does not require
systemic uptake and distribution to produce its rapid-onset
anti-anxiety effects.
VistaGen recently initiated its PALISADE Phase 3 program with
PALISADE-1, a U.S., multi-center, randomized, double-blind,
placebo-controlled Phase 3 clinical study to evaluate the efficacy
and safety of PH94B for the acute treatment of anxiety in adults
with SAD. The Company expects to initiate PALISADE-2, the second
U.S. Phase 3 study in its PALISADE Phase 3 program, in the second
half of 2021. If successful, these clinical studies are designed to
be among the studies necessary to support a potential U.S. New Drug
Application (NDA) to the FDA. PH94B has been granted Fast Track
designation status by the FDA for development as an acute treatment
of anxiety in adults with SAD.
In addition to SAD, the Company is also preparing for
exploratory Phase 2A clinical studies of PH94B in adults
experiencing other anxiety disorders, including adjustment disorder
with anxiety, postpartum anxiety, post-traumatic stress disorder,
and pre-procedural anxiety.
PH10
PH10 is a synthetic investigational neurosteroid, which also was
developed from proprietary compounds called pherines. Its novel,
rapid-onset MOA is fundamentally differentiated from the MOA of all
current treatments for major depressive disorder (MDD) and other
depression disorders. PH10 is self-administered at microgram-level
doses as an odorless nasal spray. PH10 activates nasal chemosensory
cells in the nasal passages, connected to neural circuits in the
brain that produce antidepressant effects. Specifically, PH10
engages peripheral chemosensory receptors in the nasal passages
that trigger a subset of neurons in the main OB that stimulate
neurons in the limbic amygdala. This is turn increases activity of
the limbic-hypothalamic sympathetic nervous system and increases
the release of catecholamines. Importantly, unlike all currently
approved oral antidepressants, PH10 does not require systemic
uptake and distribution to produce rapid-onset of antidepressant
effects. In all clinical studies to date, PH10 has not caused
psychological side effects (such as dissociation and
hallucinations) or safety concerns that may be associated with
rapid-onset ketamine-based therapy, including intravenous ketamine
or intranasal ketamine.
Exploratory Phase 2A clinical development of PH10 for MDD has
been completed. VistaGen is now preparing for Phase 2B clinical
development of PH10. The Company expects to initiate a U.S.
multi-center, randomized, double-blind, placebo-controlled study to
evaluate the efficacy and safety of PH10 as a potential stand-alone
treatment for MDD in mid-2022. PH10 also has potential as a novel
treatment for treatment-resistant depression, postpartum depression
and suicidal ideation. AV-101
AV-101 is an oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA)
and targets the N-methyl-D-aspartate receptor (NMDAR), an
ionotropic glutamate receptor in the brain. Abnormal NMDAR function
is associated with numerous CNS diseases and disorders. AV-101 is a
potent and selective full antagonist of the glycine co-agonist site
of the NMDAR that inhibits the function of the NMDAR. However,
unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not
an ion channel blocker. At doses administered in all studies to
date, AV-101 has been observed to be orally bioavailable, well
tolerated and has not exhibited dissociative or hallucinogenic
psychological side effects or safety concerns. In light of these
findings and data from preclinical studies, the Company believes
that AV-101, in combination with FDA-approved probenecid, has
potential to become a new oral treatment alternative for MDD and
certain neurological indications involving the NMDAR.
VistaGen is currently preparing for a Phase 1B clinical study to
evaluate AV-101 in combination with probenecid. The Company expects
to initiate the study in the second half of 2021. 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, suicidal
ideation, and epilepsy.
Key senior leadership additions
VistaGen strengthened its leadership by adding key personnel
with extensive CNS drug development and commercial experience to
drive its clinical and commercial programs through important
late-stage clinical development milestones and potential commercial
launch and beyond. The Company recently added key team members in
multiple areas such as clinical operations, research and
development, CMC, regulatory affairs and commercial operations.
Notably, the addition of Ann Cunningham as the Company’s Chief
Commercial Officer has advanced pre-commercial planning for PH94B
in SAD, as well as for a broad range of other anxiety and
depression markets. The Company also added pharmaceutical industry
veteran Dr. Joanne Curley to its Board of Directors. Dr. Curley has
deep experience in pharmaceutical product development, operations,
and commercialization.
Fiscal Year 2021 Financial Results
Revenue: The Company recognized $1.1 million in
sublicense revenue from its $5 million non-dilutive upfront payment
pursuant to its PH94B development and commercialization agreement
with EverInsight Therapeutics (now AffaMed Therapeutics) during the
year ended March 31, 2021, compared to none in the year ended March
31, 2020.
Research and development (R&D) expense:
Research and development expense decreased from $13.4 million to
$12.5 million for the years ended March 31, 2020 and 2021,
respectively. The decrease is primarily due to the completion of a
Phase 2 clinical study of AV-101 in MDD in Fiscal 2020, offset by
increased development expenses for PH94B and PH10 in Fiscal
2021.
General and administrative (G&A) expense:
General and administrative expense decreased to approximately $6.5
million from approximately $7.4 million for the years ended March
31, 2021 and 2020, respectively. Cash compensation expense for the
year ended March 31, 2021 increased by approximately $0.7 million,
including the impact of new employees, and was offset by a decrease
of approximately $1.0 million in noncash stock-based compensation
for the year ended March 31, 2021 compared to those expenses in the
year ended March 31, 2020. Further, in the year ended March 31,
2020, the Company modified certain outstanding warrants and
recognized non-cash warrant modification expense of approximately
$0.8 million.
Net loss: Net loss for the fiscal years ended
March 31, 2021 and 2020 was approximately $17.9 million and $20.8
million, respectively.
Cash Position: At March 31, 2021, the Company
had cash and cash equivalents of approximately $103.1 million.
As of June 29, 2021, the Company had 191,382,350 shares of
common stock outstanding.
Conference Call
VistaGen will host a conference call and live audio webcast this
afternoon at 2:00 p.m. Pacific Time to provide a corporate update
and discuss its financial results for its fiscal year ended March
31, 2021.U.S. Dial-in (Toll Free): 1-877-407-9716International
Dial-in Number (Toll): 1-201-493-6779Conference ID: 13720908Webcast
Link:
http://public.viavid.com/index.php?id=145419
A telephone playback of the conference call will be available
after approximately 5:00 p.m. Pacific Time on June
29, 2020. 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
13720908.
About VistaGenVistaGen Therapeutics is a
biopharmaceutical company committed to developing and
commercializing innovative medicines with the potential to go
beyond the current standard of care for anxiety, depression, and
other CNS disorders. Each of VistaGen's drug candidates has a
differentiated potential mechanism of action, has been
well-tolerated in all clinical studies to date and has therapeutic
potential in multiple CNS indications. For more information, please
visit www.VistaGen.com and connect with VistaGen on Twitter,
LinkedIn, and Facebook.
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 us and our management, are
inherently uncertain. Our 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 our planned clinical trials, including
delays due to the impact of the COVID-19 pandemic; fluctuating
costs of materials and other resources required to conduct our
planned clinical and non-clinical trials; market conditions; the
impact of general economic, industry or political conditions in the
United States or internationally; adverse healthcare reforms and
changes of laws and regulations; manufacturing and marketing risks,
which may include, but are not limited to, unavailability of or
delays in delivery of raw materials for manufacture of our CNS drug
candidates and difficulty in initiating or conducting clinical
trials; inadequate and/or untimely supply of one or more of our CNS
drug candidates to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of our CNS drug candidates; and
the risks more fully discussed in the section entitled "Risk
Factors" in our most recent Annual Report on Form 10-K for the
fiscal year ended March 31, 2021, filed earlier today, as well as
discussions of potential risks, uncertainties, and other important
factors in our other filings with the U.S. Securities and Exchange
Commission (SEC). Our SEC filings are available on the SEC’s
website at www.sec.gov. You should not place undue reliance on
these forward-looking statements, which apply only as of the date
of this press release and should not be relied upon as representing
our views as of any subsequent date. We explicitly disclaim any
obligation to update any forward-looking statements, other than as
may be required by law. If we do update one or more forward-looking
statements, no inference should be made that we will make
additional updates with respect to those or other forward-looking
statements.
VistaGen Company ContactsMark McPartland and
Mark FlatherVistaGen Therapeutics Phone: (650) 577-3606; (650)
577-3617Email: IR@vistagen.com
|
|
VISTAGEN THERAPEUTICS, INC. |
CONSOLIDATED BALANCE SHEETS |
(Amounts in dollars, except share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
103,108,300 |
|
|
$ |
1,355,100 |
|
Receivable from collaboration partner |
|
|
|
40,600 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
|
835,100 |
|
|
|
225,100 |
|
Deferred contract acquisition costs - current portion |
|
|
|
133,500 |
|
|
|
- |
|
Total current assets |
|
|
|
104,117,500 |
|
|
|
1,580,200 |
|
Property and equipment, net |
|
|
|
367,400 |
|
|
|
209,600 |
|
Right of use asset - operating lease |
|
|
|
3,219,600 |
|
|
|
3,579,600 |
|
Deferred offering costs |
|
|
|
294,900 |
|
|
|
355,100 |
|
Deferred contract acquisition costs - non-current portion |
|
|
|
234,100 |
|
|
|
- |
|
Security deposits and other assets |
|
|
|
47,800 |
|
|
|
47,800 |
|
Total assets |
|
|
$ |
108,281,300 |
|
|
$ |
5,772,300 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
|
$ |
838,300 |
|
|
$ |
1,836,600 |
|
Accrued expenses |
|
|
|
1,562,700 |
|
|
|
561,500 |
|
Current notes payable |
|
|
|
- |
|
|
|
56,500 |
|
Deferred revenue - current portion |
|
|
|
1,420,200 |
|
|
|
- |
|
Operating lease obligation - current portion |
|
|
|
364,800 |
|
|
|
313,400 |
|
Financing lease obligation - current portion |
|
|
|
3,000 |
|
|
|
3,300 |
|
Total current liabilities |
|
|
|
4,189,000 |
|
|
|
2,771,300 |
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
Accrued dividends on Series B Preferred Stock |
|
|
|
6,272,700 |
|
|
|
5,011,800 |
|
Deferred revenue - non-current portion |
|
|
|
2,490,300 |
|
|
|
- |
|
Operating lease obligation - non-current portion |
|
|
|
3,350,800 |
|
|
|
3,715,600 |
|
Financing lease obligation - non-current portion |
|
|
|
- |
|
|
|
3,000 |
|
Total non-current liabilities |
|
|
|
12,113,800 |
|
|
|
8,730,400 |
|
Total liabilities |
|
|
|
16,302,800 |
|
|
|
11,501,700 |
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
March 31, 2021 and 2020: |
|
|
|
|
|
Series A Preferred, 500,000 shares authorized, issued and
outstanding at March 31, 2021 and 2020 |
|
|
|
500 |
|
|
|
500 |
|
Series B Preferred; 4,000,000 shares authorized at March 31, 2021
and 2020; 1,131,669 shares |
|
|
|
|
|
and 1,160,240 shares issued and outstanding at March 31, 2021 and
2020, respectively |
|
|
|
1,100 |
|
|
|
1,200 |
|
Series C Preferred; 3,000,000 shares authorized at March 31, 2021
and 2020; 2,318,012 shares |
|
|
|
|
|
issued and outstanding at March 31, 2021 and 2020 |
|
|
|
2,300 |
|
|
|
2,300 |
|
Series D Preferred; 2,000,000 shares and no shares authorized at
March 31, 2021 and 2020, respectively; |
|
|
|
|
|
402,149 shares and no shares issued and outstanding at March 31,
2021 and March 31, 2020, respectively |
|
|
|
400 |
|
|
|
- |
|
Common stock, $0.001 par
value; 325,000,000 shares and 175,000,000 shares authorized at
March 31, 2021 and 2020, |
|
|
|
|
|
respectively; 180,751,234 and 49,348,707 shares issued at March 31,
2021 and 2020, respectively |
|
|
|
180,800 |
|
|
|
49,300 |
|
Additional paid-in capital |
|
|
|
315,603,100 |
|
|
|
200,092,800 |
|
Treasury stock, at cost, 135,665 shares of common stock held at
March 31, 2021 and 2020 |
|
|
|
(3,968,100 |
) |
|
|
(3,968,100 |
) |
Accumulated deficit |
|
|
|
(219,841,600 |
) |
|
|
(201,907,400 |
) |
Total stockholders’ equity (deficit) |
|
|
|
91,978,500 |
|
|
|
(5,729,400 |
) |
Total liabilities and stockholders’ equity (deficit) |
|
|
$ |
108,281,300 |
|
|
$ |
5,772,300 |
|
|
|
|
|
|
|
VISTAGEN THERAPEUTICS |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Amounts in Dollars, except share amounts) |
|
|
|
|
|
|
|
|
Fiscal Years Ended March 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Sublicense revenue |
|
$ |
1,089,500 |
|
|
$ |
- |
|
Total revenues |
|
|
1,089,500 |
|
|
|
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
12,476,400 |
|
|
|
13,374,200 |
|
General and administrative |
|
|
6,546,900 |
|
|
|
7,427,300 |
|
Total operating expenses |
|
|
19,023,300 |
|
|
|
20,801,500 |
|
Loss from operations |
|
|
(17,933,800 |
) |
|
|
(20,801,500 |
) |
Other income and expenses, net: |
|
|
|
|
Interest income, net |
|
|
1,600 |
|
|
|
30,100 |
|
Other income |
|
|
600 |
|
|
|
- |
|
Loss before income taxes |
|
|
(17,931,600 |
) |
|
|
(20,771,400 |
) |
Income taxes |
|
|
(2,600 |
) |
|
|
(2,600 |
) |
Net loss and comprehensive loss |
|
$ |
(17,934,200 |
) |
|
$ |
(20,774,000 |
) |
|
|
|
|
|
Accrued dividends on Series B Preferred stock |
|
|
(1,385,600 |
) |
|
|
(1,263,600 |
) |
Beneficial conversion feature on Series D |
|
|
|
|
Preferred stock |
|
|
(23,000,000 |
) |
|
|
- |
|
|
|
|
|
|
Net loss attributable to common stockholders |
|
$ |
(42,319,800 |
) |
|
$ |
(22,037,600 |
) |
|
|
|
|
|
Basic and diluted net loss attributable to common |
|
|
|
|
stockholders per common share |
|
$ |
(0.49 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
|
Weighted average shares used in computing |
|
|
|
|
basic and diluted net loss attributable to common |
|
|
|
|
stockholders per common share |
|
|
86,133,644 |
|
|
|
43,869,523 |
|
|
|
|
|
|
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