Evoke Pharma Inc Stock Price, News & Analysis

Evoke Pharma, focused on treatments for gastrointestinal diseases, reported its Q3 2020 financial results, highlighting the commercial launch of GIMOTI, a nasal treatment for diabetic gastroparesis, in partnership with EVERSANA.

The net loss was approximately $2.1 million, or $0.08 per share, compared to a loss of $1.6 million, or $0.07 per share, in Q3 2019. Operating expenses rose to $2.1 million driven by commercialization efforts. As of September 30, 2020, cash and equivalents stood at $6.3 million, expected to fund operations into Q2 2021, excluding potential GIMOTI revenue.

Evoke Pharma has announced the commercial launch of Gimoti (metoclopramide) nasal spray, designed specifically for adults suffering from acute and recurrent diabetic gastroparesis. This treatment allows for medication absorption via the nasal mucosa, bypassing gastrointestinal issues common in these patients. Approved by the FDA in June 2020, Gimoti offers a novel alternative to traditional oral medications, which can be ineffective due to unpredictable stomach emptying. With support from EVERSANA, the launch aims to address a significant market need and improve patient outcomes.

Evoke Pharma (EVOK) announced the appointment of Christopher Quesenberry as Chief Commercial Officer for Gimoti, approved by the FDA for treating diabetic gastroparesis. With over 30 years in pharma strategy, Quesenberry will lead the commercialization efforts alongside partner EVERSANA. The collaboration aims to ensure successful market entry and sales for Gimoti, expected to launch in Q4 2020. Evoke's President emphasized the importance of Quesenberry's expertise in executing their commercialization strategy for this critical GI disorder treatment.

Evoke Pharma, Inc. (NASDAQ: EVOK) announced its Q2 2020 financial results, showing a net loss of approximately $7.0 million or $0.28 per share, significantly higher than the $2.1 million net loss in Q2 2019. Research and development expenses surged to $5.8 million due to a $5 million technology acquisition milestone linked to the FDA approval of Gimoti, the first outpatient treatment for diabetic gastroparesis. The company expects to launch Gimoti in Q4 2020 with commercial partner EVERSANA, and reported cash reserves of $8.0 million, sufficient to fund operations into Q2 2021.

Evoke Pharma, Inc. (NASDAQ: EVOK) has commenced the commercial manufacturing of Gimoti™ (metoclopramide) nasal spray with manufacturing partner Patheon. Approved by the FDA on June 19, 2020, Gimoti is intended for adults suffering from diabetic gastroparesis. The company plans to launch sales in Q4 2020 in collaboration with EVERSANA. CEO David Gonyer emphasized the acceleration of pre-commercialization activities, ensuring the timely completion of manufacturing ahead of the launch.

Evoke Pharma (NASDAQ: EVOK) reported approximately $8.0 million in cash as of June 30, 2020, sufficient to fund operations into Q2 2021. The company anticipates launching GIMOTI, the first nasal treatment for diabetic gastroparesis, in Q4 2020 through its partner EVERSANA. This partnership will help mitigate capital investment needs by leveraging EVERSANA's resources for commercialization. GIMOTI addresses a significant unmet need in the treatment of diabetic gastroparesis, which affects millions of patients. Forward-looking statements caution potential risks in achieving growth.

Evoke Pharma, Inc. has received FDA approval for GIMOTI (metoclopramide) nasal spray, the first treatment for acute and recurrent diabetic gastroparesis. This novel therapy promises to address significant patient needs by offering a non-oral option that improves symptom relief. Evoke plans to begin commercial sales in Q4 2020, aided by a $5 million line of credit from EVERSANA. With approximately $4.7 million in cash, the company expects to sustain operations into 2021, potentially enhancing its market position in the gastrointestinal treatment landscape.

Evoke Pharma (NASDAQ: EVOK) has received conditional FDA approval for its proprietary brand name, Gimoti, for a nasal spray targeting symptoms of acute and recurrent diabetic gastroparesis in adult women. The name was developed following FDA guidelines and aims to prevent medication errors. The nasal spray is designed to enhance drug absorption by bypassing the dysfunctional GI tract, which is crucial for patients suffering from this condition. If approved, Gimoti could provide significant treatment options in a market where metoclopramide is currently available only in oral and injectable forms.

Evoke Pharma reported its first quarter 2020 financial results, revealing a net loss of approximately $1.8 million, or $0.07 per share, an improvement from a loss of $2.0 million, or $0.11 per share, in Q1 2019. R&D expenses decreased to $0.5 million, while general and administrative expenses rose slightly to $1.3 million. Cash and cash equivalents stood at around $4.1 million, expected to last until Q3 2020. The FDA's PDUFA date for Gimoti is June 19, 2020, which is crucial for advancing their commercialization strategy with Eversana Life Sciences.