Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced its financial results for the third quarter ended
September 30, 2020 and recent corporate developments.
“The third quarter was marked by preparation for
the commercial launch of GIMOTI, which we successfully implemented
in early fourth quarter. The launch of GIMOTI to treat symptoms of
acute and recurrent diabetic gastroparesis with our commercial
partner EVERSANA marked a pivotal event for the Company,” said
David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “As a
nasally delivered product, GIMOTI has distinct differences over
oral formulations of metoclopramide. It is the only outpatient
non-oral treatment option to help improve the quality of life for
patients suffering with diabetic gastroparesis. Initial
prescriptions of GIMOTI have already been filled at the EVERSANA
specialty pharmacy through our patient support team at
EvokeAssist™. We believe this vital support program will aid both
physicians and patients through enrollment, reimbursement, and
delivery of GIMOTI directly to the patient. Given the milestones
achieved for commercial preparedness, we believe we are in a strong
position as we launch GIMOTI and address a significant unmet
medical need for millions of patients suffering from diabetic
gastroparesis.”
Third Quarter 2020
Developments and Recent
Progress:
- Launched GIMOTI with commercial
partner, EVERSANA, in line with prior guidance
- Implemented EvokeAssist, an
integrated patient support program
- Appointed Chris Quesenberry as
Chief Commercial Officer for GIMOTI through our Commercial partner,
EVERSANA
- Built an entire commercial team,
including field sales and call center
- Completed manufacturing of the
first commercial lot of GIMOTI
Third Quarter 2020
Financial Review
For the third quarter of 2020, net loss was
approximately $2.1 million, or $0.08 per share, compared to a net
loss of approximately $1.6 million, or $0.07 per share, for the
third quarter of 2019.
Research and development expenses totaled
approximately $0.2 million for the third quarter of 2020, compared
to approximately $0.8 million for the third quarter of 2019. The
decrease during the three months ended September 30, 2020 was
primarily due to the decrease in research and development activity
following the GIMOTI NDA approval in June 2020.
For the third quarter of 2020, general and
administrative expenses were approximately $1.9 million compared to
approximately $0.8 million for the third quarter of 2019. The
increase during the three months ended September 30, 2020 was
primarily due to increased costs associated with our
commercialization and selling activities. Of the costs incurred
during the third quarter of 2020, approximately $745,000 were
related to commercialization activities.
Total operating expenses for the third quarter
of 2020 were approximately $2.1 million, compared to total
operating expenses of approximately $1.6 million for the third
quarter of 2019.
As of September 30, 2020, the Company’s cash and
cash equivalents were approximately $6.3 million. The Company
expects that its current cash balance will be sufficient to support
operations into the second quarter of 2021, without consideration
of potential future GIMOTI revenue.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company
focused primarily on the commercialization and development of drugs
to treat GI disorders and diseases. The Company developed GIMOTI, a
nasal spray formulation of metoclopramide, for the relief of
symptoms associated with acute and recurrent diabetic gastroparesis
in adults. GIMOTI is available by prescription through the
EvokeAssist™ patient support center. Visit www.GimotiRx.com for
more information.
Diabetic gastroparesis is a GI disorder
affecting millions of patients worldwide, in which the stomach
takes too long to empty its contents resulting in serious GI
symptoms as well as other systemic complications. The gastric delay
caused by gastroparesis can compromise absorption of orally
administered medications. GIMOTI is absorbed in the nasal cavity
and bypasses the erratic gastric absorption often seen in
gastroparesis patients. Prior to FDA approval to commercially
market GIMOTI, metoclopramide was only available in oral and
injectable formulations. It remains the only drug currently
approved in the United States to treat gastroparesis. Visit
www.EvokePharma.com for more information.
About
Gimoti™ (metoclopramide) nasal
sprayGIMOTI is indicated for the relief of symptoms in
adults with acute and recurrent diabetic gastroparesis.
Important Safety Information
WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive
dyskinesia (TD), a serious movement disorder that is often
irreversible. The risk of developing TD increases with duration of
treatment and total cumulative dosage.
- Discontinue GIMOTI in patients who
develop signs or symptoms of TD. In some patients, symptoms may
lessen or resolve after metoclopramide is stopped.
- Avoid treatment with metoclopramide
(all dosage forms and routes of administration) for longer than 12
weeks because of the increased risk of developing TD with
longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk
of developing tardive dyskinesia (TD) and other extrapyramidal
symptoms as well as the risk of methemoglobinemia in neonates.
- Moderate or severe hepatic
impairment (ChildPugh B or C), moderate or severe renal impairment
(creatinine clearance less than 60 mL/minute), and patients
concurrently using strong CYP2D6 inhibitors due to the risk of
increased drug exposure and adverse reactions.
GIMOTI is contraindicated:
- In patients with a history of
tardive dyskinesia (TD) or a dystonic reaction to
metoclopramide.
- When stimulation of
gastrointestinal motility might be dangerous (e.g., in the presence
of gastrointestinal hemorrhage, mechanical obstruction, or
perforation).
- In patients with pheochromocytoma
or other catecholamine-releasing paragangliomas. Metoclopramide may
cause a hypertensive/pheochromocytoma crisis, probably due to
release of catecholamines from the tumor.
- In patients with epilepsy.
Metoclopramide may increase the frequency and severity of
seizures.
- In patients with hypersensitivity
to metoclopramide. Reactions have included laryngeal and glossal
angioedema and bronchospasm.
Potential adverse reactions associated with
metoclopramide include: Tardive dyskinesia (TD), other
extrapyramidal effects (EPS), parkinsonism symptoms, motor
restlessness, neuroleptic malignant syndrome (NMS), depression,
suicidal ideation and suicide, hypertension, fluid retention,
hyperprolactinemia, effects on the ability to drive and operate
machinery.
Most common adverse reactions (≥5%) for GIMOTI
are: dysgeusia, headache, and fatigue.
These are not all of the possible side effects
of GIMOTI. Call your doctor for medical advice about whether you
should take GIMOTI and the possible risk factors and side effects.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Safe Harbor Statement
Evoke cautions you that statements included in
this press release that are not a description of historical facts
are forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negatives of these
terms or other similar expressions. These statements are based on
the company’s current beliefs and expectations. These
forward-looking statements include statements regarding: the size
of the gastroparesis market and the potential of GIMOTI to provide
an important new alternative to current treatment options. The
inclusion of forward-looking statements should not be regarded as a
representation by Evoke that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Evoke’s
business, including, without limitation: Evoke’s and EVERSANA’s
ability to successfully drive market demand for GIMOTI; Evoke’s
ability to obtain additional financing as needed to support its
operations, including through the EVERSANA line of credit which is
subject to certain customary conditions; the COVID-19 pandemic may
disrupt Evoke’s and EVERSANA’s business operations impairing the
ability to commercialize GIMOTI and Evoke’s ability to generate any
product revenue; Evoke’s dependence on third parties for the
manufacture of GIMOTI; Evoke is entirely dependent on the success
of GIMOTI; inadequate efficacy or unexpected adverse side effects
relating to GIMOTI that could result in recalls or product
liability claims; Evoke’s ability to obtain and maintain
intellectual property protection for GIMOTI; and other risks
detailed in Evoke’s prior press releases and in the periodic
reports it files with the Securities and Exchange Commission. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and Evoke
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
TABLES TO FOLLOW
Evoke Pharm, Inc.
Balance Sheets
|
September
30, 2020 |
|
December 31,
2019 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
6,280,656 |
|
|
$ |
5,663,833 |
|
Prepaid expenses |
|
336,432 |
|
|
|
581,706 |
|
Inventory |
|
86,145 |
|
|
|
— |
|
Other current assets |
|
11,551 |
|
|
|
— |
|
Total
current assets |
|
6,714,784 |
|
|
|
6,245,539 |
|
Operating
lease right-of-use asset |
|
36,115 |
|
|
|
138,538 |
|
Other
assets |
|
— |
|
|
|
11,551 |
|
Total
assets |
$ |
6,750,899 |
|
|
$ |
6,395,628 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
765,603 |
|
|
$ |
1,033,383 |
|
Accrued compensation |
|
715,423 |
|
|
|
843,162 |
|
Operating lease liability |
|
36,115 |
|
|
|
138,538 |
|
Paycheck protection program loan |
|
104,168 |
|
|
|
— |
|
Milestone payable |
|
5,000,000 |
|
|
|
— |
|
Total
current liabilities |
|
6,621,309 |
|
|
|
2,015,083 |
|
|
|
|
|
Long-term
Liabilities: |
|
|
|
Note payable |
|
2,000,000 |
|
|
|
— |
|
Accrued interest payable |
|
53,005 |
|
|
|
— |
|
Total
long-term liabilities |
|
2,053,005 |
|
|
|
— |
|
|
|
|
|
Total
liabilities |
|
8,674,314 |
|
|
|
2,015,083 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Common stock |
|
2,633 |
|
|
|
2,443 |
|
Additional paid-in capital |
|
94,691,151 |
|
|
|
90,108,492 |
|
Accumulated deficit |
|
(96,617,199 |
) |
|
|
(85,730,390 |
) |
Total
stockholders' (deficit) equity |
|
(1,923,415 |
) |
|
|
4,380,545 |
|
Total
liabilities and stockholders' (deficit) equity |
$ |
6,750,899 |
|
|
$ |
6,395,628 |
|
|
|
|
|
Evoke Pharma, Inc.
Statement of
Operations(Unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
205,032 |
|
|
$ |
822,444 |
|
|
$ |
6,450,979 |
|
|
$ |
2,774,924 |
|
General and administrative |
|
1,874,578 |
|
|
|
814,218 |
|
|
|
4,387,284 |
|
|
|
2,955,371 |
|
Total
operating expenses |
|
2,079,610 |
|
|
|
1,636,662 |
|
|
|
10,838,263 |
|
|
|
5,730,295 |
|
Loss from
operations |
|
(2,079,610 |
) |
|
|
(1,636,662 |
) |
|
|
(10,838,263 |
) |
|
|
(5,730,295 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest income |
|
1,033 |
|
|
|
8,597 |
|
|
|
4,896 |
|
|
|
22,868 |
|
Interest expense |
|
(50,528 |
) |
|
|
— |
|
|
|
(53,442 |
) |
|
|
— |
|
Total other
income (expense), net |
|
(49,495 |
) |
|
|
8,597 |
|
|
|
(48,546 |
) |
|
|
22,868 |
|
Net
loss |
$ |
(2,129,105 |
) |
|
$ |
(1,628,065 |
) |
|
$ |
(10,886,809 |
) |
|
$ |
(5,707,427 |
) |
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
26,146,220 |
|
|
|
24,128,060 |
|
|
|
25,191,359 |
|
|
|
21,623,648 |
|
|
|
|
|
|
|
|
|
Investor Contact:The Ruth GroupJan Medina, CFATel:
646-536-7035jmedina@theruthgroup.com
Media Contact:The Ruth GroupKirsten ThomasTel:
508-280-6592kthomas@theruthgroup.com
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