HOLLISTON, Mass., Aug. 11, 2016 /PRNewswire/ -- Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, today announced financial results for the three months ended June 30, 2016. The Company also reviewed recent corporate highlights and provided an update on expected near-term milestones. As previously announced, Biostage management will host a business update conference call and live webcast, with accompanying presentation slides, for investors, analysts and other interested parties today at 9 AM ET (details below).
Jim McGorry, CEO of Biostage, commented, "The second quarter of 2016 has proven to be the Company's best execution and operational quarter to date, and I am thrilled with our progress. We advanced our clinical and regulatory strategy by executing on all fronts in earnest and have prepared Biostage for upcoming catalytic events which we expect will drive value in the near-term."
Recent Corporate, Development and Regulatory Highlights
- Bolstered executive management team and board adding scientific, regulatory and business development expertise: Harout DerSimonian, Ph.D., Chief Scientific Officer, Laura Mondano, Vice President of Regulatory Affairs and Blaine McKee, Ph.D., independent Board Member;
- Submitted request for orphan drug designation (ODD) with the U.S. Food and Drug Administration (FDA) for esophageal implant;
- Announced positive, confirmatory proof-of-concept pre-clinical results demonstrating successful esophagus regeneration in study conducted with Mayo Clinic;
- Commenced pre-clinical studies required by the FDA for IND submission for the Company's lead product candidate, the Cellspan Esophageal Implant; and
- Commenced additional pre-clinical large-animal studies in collaboration with Mayo Clinic, focused on the Company's bronchial implant technology.
Mr. McGorry added, "Also throughout the quarter, we made key appointments to our management team and board attracting industry veterans with proven track records of success. This is undoubtedly a testament to our groundbreaking technology platform and validation of our growing body of compelling, positive data. I firmly believe their collective contributions will be integral to Biostage's transition to human clinical trials in 2017 our next phase of growth and development."
Expected Near-Term Milestones
- Emerge as clinical-stage Company with the start of first human clinical studies for esophageal implant program in the first half of 2017;
- Finalize manuscript and publication with Mayo Clinic on esophageal regeneration and host KOL events by year-end with data updates;
- File IND application with the FDA for our esophageal implant product candidate by end of 2016;
- Advance the development and submit IND for pediatric esophageal atresia, a congenital disorder in children where a baby is born with an incomplete esophagus;
- Extend Cellframe technology as a platform for broader and additional indications to include the bronchus in collaboration with Mayo Clinic in 2017; and
- Receive ODD for esophageal implant by early 2017.
"Fundamentally, Biostage has never been stronger, and we are poised to make a significant leap from a preclinical company to a clinical stage company with the potential to unlock significant shareholder value. Importantly, as we further execute on all fronts, we will continue to best position our company to bring valuable organ regeneration products to underserved patient populations in the coming years," concluded Mr. McGorry.
Second Quarter Ended June 30, 2016 Financial Highlights
- Q2 2016 net loss was $2.7 million, or $0.17 per basic share, compared to $4.5 million, or $0.44 per basic share, for Q2 2015.
- Research and development expense increased $0.6 million to $1.7 million in Q2 2016 compared with $1.1 million in Q2 2015, due primarily to increased spending on preclinical studies of $0.3 million, outsourced lab services of $0.1M, payroll related and other expenses totaling $0.2 million.
- Selling, general and administrative expense decreased $2.3 million to $1.2 million in Q2 2016 compared with $3.5 million in Q2 2015 due to a $2.2 million decrease in non-cash stock-based compensation costs related primarily to the departure of the Company's former CEO in April 2015, and decreases of $0.2 million and $0.1 million in recruiting cost and other costs, respectively. Those decreases were partially offset by a $0.2 million cost increase related to the Company's name change to Biostage and greater investor communications efforts.
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