עומר רגב
07/05/2015
Tel Aviv, Israel – May 6, 2015 – Alcobra Ltd. (NasdaqGM: 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, today 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 fourt 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
About Alcobra Ltd:
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX, to treat cognitive disorders including ADHD and Fragile X Syndrome. MDX has completed multiple Phase II studies in adults and adolescents with ADHD and has completed a Phase III study in adults with ADHD.
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the timing, design, completion and reporting results of clinical studies, Alcobra’s ability to better design future studies and reduce high placebo response, reaching the milestones required for FDA approval, timing of submitting a Pediatric Study Plan to the FDA and statements regarding future use of cash and the sufficiency of the company's financial resources to meet certain milestones and whether such milestones may be achieved at all. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would not be interpreted differently in light of additional research or otherwise. Also, while the FDA has indicated to Alcobra that positive efficacy
הנתונים, המידע, הדעות והתחזיות המתפרסמות באתר זה מסופקים כשרות לגולשים. אין לראות בהם המלצה או תחליף לשיקול דעתו העצמאי של הקורא, או הצעה או שיווק השקעות או ייעוץ השקעות ב: קרנות נאמנות, תעודות סל, קופות גמל, קרנות פנסיה, קרנות השתלמות או כל נייר ערך אחר או נדל"ן– בין באופן כללי ובין בהתחשב בנתונים ובצרכים המיוחדים של כל קורא – לרכישה ו/או ביצוע השקעות ו/או פעולות או עסקאות כלשהן. במידע עלולות ליפול טעויות ועשויים לחול בו שינויי שוק ושינויים אחרים. כמו כן עלולות להתגלות סטיות בין התחזיות המובאות בסקירה זו לתוצאות בפועל. לכותב עשוי להיות עניין אישי במאמר זה, לרבות החזקה ו/או ביצוע עסקה עבור עצמו ו/או עבור אחרים בניירות ערך ו/או במוצרים פיננסיים אחרים הנזכרים במסמך זה. הכותב עשוי להימצא בניגוד עניינים. פאנדר אינה מתחייבת להודיע לקוראים בדרך כלשהי על שינויים כאמור, מראש או בדיעבד. פאנדר לא תהיה אחראית בכל צורה שהיא לנזק או הפסד שיגרמו משימוש במאמר/ראיון זה, אם יגרמו, ואינה מתחייבת כי שימוש במידע זה עשוי ליצור רווחים בידי המשתמש.
