Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2014 |
Accounting Policies [Abstract] | ' |
Organization and Basis of Presentation | ' |
1. ORGANIZATION AND BASIS OF PRESENTATION |
MELA Sciences, Inc., a Delaware corporation (the “Company”), is a medical device company primarily focused on the commercialization of its flagship product, the MelaFind® system, and the further design and development of MelaFind® and its technology. The MelaFind® system is an optical diagnostic device that assists dermatologists in the diagnosis of melanoma. The MelaFind® system features a hand-held component that uses light of differing wavelengths to capture digital data from clinically atypical pigmented skin lesions. The data are then analyzed utilizing sophisticated classification algorithms that have been ‘trained’ and blind tested on the Company’s proprietary database of melanomas and benign lesions. The MelaFind® system then provides images and objective data on the relative disorganization of a lesion’s structure that provides substantial additional perspective to assist physicians in the clinical management decision for atypical pigmented skin lesions, including information useful in the decision whether to biopsy the lesion. |
The components of the MelaFind® system include: |
|
| • | | a hand-held component, which employs high precision optics and multi-spectral illumination (multiple colors of light including near infra-red); |
|
| • | | a proprietary database of pigmented skin lesions, believed to be the largest positive prospective database to date in the US; and |
|
| • | | lesion classifiers, which are sophisticated mathematical algorithms that extract lesion feature information and classify lesions. |
In November 2011, the Company received written approval from the U.S. Food and Drug Administration (“FDA”) for the MelaFind® Pre-Market Approval (“PMA”) application and in September 2011 received Conformite Europeenne (“CE”) Mark approval. In March 2012, the Company installed the first commercial MelaFind® systems, and proceeded with the commercial launch of MelaFind®. The Company is currently conducting a Post-Approval Study (“PAS”) evaluating the sensitivity and false positive rate of physicians after using the MelaFind® system to their performance if MelaFind® was not available. |
In 2012 the Company evolved from a research and development company to a commercial enterprise. The launch of MelaFind® in 2012 and the subsequent commercialization activities supporting the launch did not meet the Company’s initial goals and objectives. Revenues were lower than forecasted and expenses continued to increase throughout 2012 and into 2013. |
In the third quarter of 2013, a significant cost reduction program was put into place. In November 2013, the Company appointed a new CEO and adopted a refocused “Go-to-Market” strategy concentrating on key institutions, opinion leaders and dermatologists who treat many of the patients at high risk for melanoma. As part of this strategy, in late December 2013, the Company changed its business model for the MelaFind® system from a rental-based to a sales-based model. The Company has reduced its costs, added more experience to its management team, and reorganized its sales and marketing activities to better support the commercialization of the MelaFind® system. The Company is also seeking a coverage determination from the Centers for Medicare & Medicaid Services, the federal agency that administers Medicare, as a prerequisite to obtain reimbursement by Medicare for use of the MelaFind® system. This process could take up to two years. Once a coverage determination has been made, the Company plans to seek reimbursement by Medicaid, Medicare and other third-party payers. |
On August 22, 2013, the Company received a notice from The NASDAQ Stock Market that, for the previous 30 consecutive business days, the Company was not in compliance with the minimum bid price requirement of $1.00 per share for continued listing on the NASDAQ Capital Market. The Company was granted an automatic 180 grace period by NASDAQ in which to regain compliance. On February 19, 2014, the Company was notified by NASDAQ that the Company was eligible for an additional 180 day grace period and has until August 18, 2014 to regain compliance with NASDAQ’s minimum bid price requirement or risk delisting. |
On October 17, 2013, the FDA notified the Company that its report with respect to the PAS was inadequate to allow the agency to complete its review, and as a result revised the PAS status on the FDA website to “Progress Inadequate.” In January 2014, the Company’s revised enrollment plan and schedule was approved by the FDA and the interactive review process was closed. On April 2, 2014, the FDA updated the study status to “Progress Adequate” and approved our new study timeline. The Company currently targets submission of the PAS report the FDA by year-end 2017. |
In February 2014, the Company sold to two investors (the “Purchasers”) (i) an aggregate of 12,300 shares of Series A Convertible Preferred Stock, (the “Series A Preferred Stock”), convertible into 14,642,857 shares of common stock at an initial conversion price of $0.84, and (ii) warrants to purchase up to 13,297,297 shares of the Company’s common stock, for net proceeds of approximately $11.4 million. The warrants have an exercise price of $0.74 per share, are immediately exercisable and have a term of five years. The number of shares issuable upon conversion of the Series A Preferred Stock and exercise of the warrants are adjustable in the event of stock splits, stock dividends, combinations of shares and similar transactions. The Purchasers have been granted rights of participation in future offerings of our securities for one year. In addition, as a condition of the financing, the Company’s directors purchased an aggregate of 202,703 shares of common stock at a price of $0.74 per share, for aggregate gross proceeds of $150,000. |
The warrant obligation fell within the scope of Accounting Standards Codification 815 “Derivatives and Hedging” (“ASC 815”) and therefore the warrant obligation was accounted for as a derivative. |
In connection with this financing, the Company also granted to the Purchasers resale registration rights with respect to the shares of common stock underlying the Series A Preferred Stock and the warrants pursuant to the terms of a Registration Rights Agreement. The Purchasers were entitled to receive liquidated damages upon the occurrence of a number of events relating to filing, effectiveness and maintaining an effective registration statement covering the shares underlying the Series A Preferred Stock and the warrants. The Company was unable to meet certain filing and effectiveness requirements and as a result paid liquidated damages to the Purchasers in the aggregate amount of approximately $3.4 million. Under the terms of the Registration Rights Agreement, the Company filed a registration statement on March 18, 2014, which was declared effective by the SEC on April 3, 2014. Should this registration statement cease to remain effective for more than ten consecutive calendar days or more than an aggregate of 15 calendar days during any 12-month period, the Company would be subject to additional liquidated damages of up to approximately $500,000. |
The unaudited condensed financial statements included herein have been prepared from the books and records of the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for reporting on Form 10-Q. The information and note disclosures normally included in complete financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. |
The Company’s management is responsible for the financial statements included in this document. The Company’s interim financial statements are unaudited. Interim results may not be indicative of the results that may be expected for the year. However, the Company believes all adjustments considered necessary for a fair presentation of these interim financial statements have been included and are of a normal and recurring nature. |
Liquidity |
The Company has experienced recurring losses and negative cash flow from operations and management expects these conditions to continue for the foreseeable future. As a result of these factors, the Company has been and continues to be dependent on raising capital from the sale of securities in order to continue to operate and to meet its obligations in the ordinary course of business. In February 2014, as noted above, the Company raised net proceeds of approximately $11.5 million from the sale of Series A Preferred Stock, common stock and warrants to strengthen the Company’s financial position. |
The Company’s net losses have had a significant negative impact on working capital and its financial position and may impact the Company’s future ability to meet its obligations in the ordinary course of business. As a result, management believes that there is significant doubt about the Company’s ability to continue as a going concern. The Company continues to assess the effects of its previously announced cost reduction plan and is prepared to reduce various operational costs as necessary. Although the Company has no specific arrangements or plans, additional capital will be needed during the upcoming months, which may take the form of equity, equity-linked or debt financing. In addition, the Company anticipates that long-term it will need to raise funds to support further advances in the technology and clinical trials. The timing and amount of any additional funding the Company may require will be affected by numerous factors, many of which are not in the control of the Company including the market acceptance of the MelaFind® system. |
There can be no assurances that the Company will be able to raise additional financing in the future. Additional funds may not become available on acceptable terms or at all and there can be no assurance that any additional funding the Company obtains will be sufficient to meet the Company’s financing needs. Any additional funding that the Company may obtain in the future could be dilutive to common stockholders, provide new investors with rights and preferences senior to common stockholders and provide for restrictive covenants that could limit the Company’s ability to take certain actions. Unless the Company is able to generate sufficient revenues or to raise additional capital near-term, the Company’s operations will be scaled back to maintain only vital activities, or discontinued. |