"We continue to be encouraged by the market response to Quell® Fibromyalgia during its strategic launch. We now have field sales capabilities in the key markets of
Recent Business Highlights:
- The Quell Fibromyalgia business provided evidence of growth with 125 unique prescribers during Q3. The cumulative number of prescriptions written increased by 53% to 752 in Q3 from 490 in Q2. Over 60% of prescriptions were filled by patients. The cumulative number of month-refills increased by 91% to 663 in Q3 from 348 in Q2.
- The Company announced a partnership with the
National Fibromyalgia Associationto expand awareness of Quell Fibromyalgia and other treatment options for individuals with the disease.
- A recent clinical trial conducted by the University of
Rochester School of Medicine and Dentistryindicated that Quell improves the symptoms and quality of life for patients with chemotherapy induced peripheral neuropathy (CIPN). The Company plans a 510(k) filing with the FDA in late 2023 or early 2024. The use of Quell for moderate to severe CIPN received a FDA breakthrough designation in January 2022.
- The Quell development pipeline includes several active clinical trials, including for fibromyalgia-like long COVID, chronic overlapping pain conditions (COPC) and peripheral edema. These indications represent potential new or expanded labels for the Quell prescription neurotherapeutics platform.
August 3, 2023the Company received a NASDAQ delisting notice for failure of its common stock to maintain a minimum bid price of $1.00per share. NASDAQ provided a 180 day period until February 5, 2024to regain compliance. A Special Meeting of Stockholders on October 19, 2023authorized the Board of Directors to implement a reverse split of the Company’s common stock, in its discretion, at a ratio of between 1:2 to 1:8, as a potential means of increasing the share price. Dr. Gozaniupdated investors on business strategy at the Emerging Growth Conferences in September and October.
Financial results in Q3 2023 were consistent with Company expectations and reflect the substantial changes to Medicare Advantage risk-adjustment reimbursement implemented by CMS in Q1 2023. Revenue in Q3 2023 of
Revenues in the nine months ended
The Company ended the period with
Company to Host Live Conference Call and Webcast
Safe Harbor Statement
The statements contained in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the company’s or management’s expectations regarding the business, as well as events that could have a meaningful impact on the company’s revenues and cash resources. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements, including, without limitation, estimates of future performance, and the ability to successfully develop, receive regulatory clearance, commercialize and achieve market acceptance for any products. There can be no assurance that future developments will be those that the company has anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, as well as other documents that may be filed from time to time with the
SVP and Chief Financial Officer
Statements of Operations
||Nine Months Ended
|Cost of revenues||421,382||693,571||1,484,240||1,888,566|
|Research and development||592,654||1,074,954||2,045,588||2,701,330|
|Sales and marketing||943,795||810,209||2,504,630||2,235,646|
|General and administrative||1,206,231||1,102,260||3,843,643||3,468,452|
|Total operating expenses||2,742,680||2,987,423||8,393,861||8,405,428|
|Loss from operations||(1,960,898||)||(1,712,991||)||(5,294,422||)||(3,885,299||)|
Condensed Balance Sheets
|Cash, cash equivalents and securities||$||17,637,675||$||21,199,727|
|Other current assets||3,067,968||2,907,260|
|Lease Obligation, net of current portion||122,870||207,516|
|Total liabilities and stockholders’ equity||$||21,286,772||$||24,669,615|
Source: NeuroMetrix, Inc.