Evoke Pharma Reports Third Quarter 2020 Financial Results
Gimoti™ commercial launch underway
“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
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
Chris Quesenberryas 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
Research and development expenses totaled approximately
For the third quarter of 2020, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2020 were approximately
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
About Gimoti™ (metoclopramide) nasal spray
GIMOTI 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
TABLES TO FOLLOW
|Cash and cash equivalents||$||6,280,656||$||5,663,833|
|Other current assets||11,551||—|
|Total current assets||6,714,784||6,245,539|
|Operating lease right-of-use asset||36,115||138,538|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||765,603||$||1,033,383|
|Operating lease liability||36,115||138,538|
|Paycheck protection program loan||104,168||—|
|Total current liabilities||6,621,309||2,015,083|
|Accrued interest payable||53,005||—|
|Total long-term liabilities||2,053,005||—|
|Additional paid-in capital||94,691,151||90,108,492|
|Total stockholders' (deficit) equity||(1,923,415||)||4,380,545|
|Total liabilities and stockholders' (deficit) equity||$||6,750,899||$||6,395,628|
Statement of Operations
|Three Months Ended
||Nine Months Ended
|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):|
|Total other income (expense), net||(49,495||)||8,597||(48,546||)||22,868|
|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|
Source: Evoke Pharma, Inc.