Alcobra Ltd (NASDAQ:ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced financial results for the first quarter ended March 31, 2015, and provided a business update.
First Quarter Ended March 31, 2015 Financial Results:
- Total operating expenses were $5.2 million, compared with $6.8 million in the fourth quarter of 2014 and $7.8 million in the first quarter of 2014.
- Net operating expenses, excluding non-cash stock based compensation, were $4.4 million, compared with $6.0 million in the fourth quarter of 2014 and $6.5 million in the first quarter of 2014.
- Research and development (R&D) expenses were $3.6 million, compared with $4.9 million in the fourth quarter of 2014 and $5.5 million in the first quarter of 2014. R&D expenses consist primarily of costs associated with the conduct of 2 clinical studies, namely, the Phase II Fragile X study and the Phase II adolescent ADHD safety and tolerability study.
- Pre-commercialization expenses were $0.3 million, compared with $0.5 million in the fourth quarter of 2014 and $0.5 million in the first quarter of 2014.
- Cash, cash equivalents and bank deposits totaled $45.0 million at March 31, 2015, compared with $21.7 million at December 31, 2014. Net cash used in operating activities was $4.6 million in the first quarter of 2015, compared with $7.8 million in the fourth quarter of 2014 and $5.7 million in the first quarter of 2014.
First Quarter and Recent Corporate Updates:
- On January 14, 2015, the company completed a public equity financing with net proceeds of $27.9 million. The financing was led by healthcare-dedicated institutional investors.
- On March 10, 2015, the company reported that its Phase II safety and tolerability study of a single administration of MDX in adolescent patients with ADHD achieved its primary endpoint.
- The company met with the FDA in the first quarter of 2015 to obtain the FDA’s feedback regarding the previously completed Phase III study in adult subjects with ADHD and discuss the future development path for MDX in adult and pediatric ADHD.
- The FDA concurred that positive efficacy results from a single additional short-term, well-controlled, efficacy study in adult ADHD, and two pediatric studies (a single Phase II and a single Phase III), will be sufficient to demonstrate efficacy for approval of MDX in these populations. Standard ICH E1 guideline will be followed for safety database.
- Alcobra’s second Phase III adult ADHD trial is expected to launch in the second quarter of 2015, and will include elements to control placebo response and reduce response variability.
- The company expects to submit for FDA’s review a Pediatric Study Plan, per FDA published guidance, in the second quarter of 2015.
- The company expects to report data from AL014, its Phase IIb study in adolescents and adults with Fragile X Syndrome, in the second quarter of 2015.
- The company believes that it has sufficient capital to fund the company’s activities through 2016, including the completion of its second Phase III study in adult ADHD.(Original Source)
Shares of Alcobra opened today at $5.93 and are currently trading down at $5.51. ADHD has a 1-year high of $22.19 and a 1-year low of $3.12. The stock’s 50-day moving average is $5.72 and its 200-day moving average is $5.22.
On the ratings front, Roth Capital analyst Debjit Chattopadhyay maintained a Buy rating on ADHD, with a price target of $10, In a report issued on February 23. The current price target represents a potential upside of 68.6% from where the stock is currently trading.
According to TipRanks.com, Chattopadhyay has a total average return of 8.0%, a 37.4% success rate, and is ranked #709 out of 3590 analysts.
Alcobra Ltd is a biopharmaceutical company which engaged in the development and commercialization of its proprietary oral drug candidate, MDX, to treat ADHD and other cognitive dysfunctions including Fragile X Syndrome.