Biodel Inc (NASDAQ:BIOD) reported financial results for the third fiscal quarter ended June 30, 2015.
Portfolio update since last fiscal quarter:
- Successful End-of-Phase 2 meeting with the FDA for the Glucagon Emergency Management (GEM) product candidate with an agreement reached on the design of the summative human factors study, the design and objectives of the pivotal clinical trial and the product stability and analytical similarity plan for the proposed 505(b)2 NDA application.
- Learned that registration batches for the GEM product candidate would be received no sooner than the third calendar quarter of 2016, resulting in delayed timelines for NDA submission; engaged in discussions with device supplier relating to contract requirements, in order to provide updated program timelines.
- Announced in May 2015 the initiation of a Phase 2b Study 3-250 multi-dose clinical trial of BIOD-531 ultra-rapid-acting prandial/basal insulin candidate. The study is not currently recruiting new subjects due to a request from the FDA to provide additional data concerning the investigational U-400 syringe used to deliver BIOD-531; additional syringe testing has been performed and will shortly be submitted to the FDA.
- Presented five abstracts at the 2015 American Diabetes Association Scientific sessions in Boston, MA from June 5-9, 2015. One oral presentation is scheduled for the European Association for the Study of Diabetes 51st Annual Meeting in Stockholm from September 14-18, 2015 and two abstract acceptances confirmed to date for poster presentation at the Diabetes Technology Meeting in Bethesda, MD from October 22-24, 2015.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: “This has been a strong quarter for Biodel financially, with the completion of a$34.5 million public offering and an ending cash balance of approximately $44 million. We are pleased with the guidance received from the FDA on requirements for NDA filing for the GEM product and are working diligently to move to resolve recent developments impacting the timelines for the GEM device and to reopen BIOD-531 enrollment as soon as possible. We look forward to updating our shareholders on these programs and to continue building shareholder value.”
Third Quarter Financial Results
Biodel reported a net loss of $6.5 million and $15.5 million, or $0.12 and $0.46 per share for the quarter and nine month period ended June 30, 2015, respectively. These results compare to a net loss of $3.2 million and $11.8 million, or $0.15 and $0.56 per share for the quarter and nine month period ended June 30, 2014, respectively.
Biodel did not recognize any revenue during the quarter and nine month period ended June 30, 2015 or 2014.
At June 30, 2015, Biodel had cash and cash equivalents of $44.4 million and 62.2 million shares of common stock outstanding. (Original Source)
Shares of Biodel today at $0.99 and are currently trading down at $0.9453. BIOD has a 1-year high of $2.05 and a 1-year low of $0.94. The stock’s 50-day moving average is $1.03 and its 200-day moving average is $1.19.
On the ratings front, Roth Capital analyst Elemer Piros maintained a Buy rating on BIOD, with a price target of $5, in a report issued on June 7. The current price target represents a potential upside of 426.3% from where the stock is currently trading. According to TipRanks.com, Piros has a total average return of -12.8%, a 23.5% success rate, and is ranked #3527 out of 3734 analysts.
Biodel Inc is a specialty biopharmaceutical company. The Company is focused on the development and commercialization of treatments for diabetes patients..