On August 16, 2016 Abeona Therapeutics Inc. (NASDAQ: ABEO) a clinical-stage biopharmaceutical company focused on delivering gene and plasma-based therapies for life-threatening rare diseases, reported financial results for the second quarter (Press release, Abeona Therapeutics, AUG 16, 2016, View Source;p=RssLanding&cat=news&id=2195628 [SID:1234514594]). The Company will provide investors an update on recent and ongoing business activities and an overview of its 2Q16 financials on, Wednesday, August 17th, at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international).
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"The second fiscal quarter of 2016 brought significant advancements in our goal of building a strong leadership position in the development of innovative therapies for rare diseases," stated Steven H. Rouhandeh, Executive Chairman. "We are excited about the initial biopotency signals seen in our Sanfilippo Type A clinical trial, and are looking forward to advancing multiple important new therapeutic candidates for the treatment of epidermolysis bullosa (EB), as announced last week. We thank our collaborators, shareholders and staff for their ongoing commitment and support as we move these therapies further into clinical development."
Timothy J. Miller, Ph.D, stated, "Abeona achieved many important regulatory and clinical milestones in the second quarter of 2016. The milestones include the dosing of the first patient in our Phase 1/2 clinical trial with ABO-102 for patients with Sanfilippo syndrome type A, the FDA allowance of our Phase 1/2 clinical study in Sanfilippo syndrome type B (MPS IIIB), and, most recently, the European regulatory approval for our MPS IIIA Phase 1/2 clinical study to be conducted at Cruces University Hospital in Bilbao, Spain. Additionally, we are excited about our new collaboration with the EB Research Partnership, EB Medical Research Foundation and Stanford University to accelerate up to three new promising EB product candidates toward commercialization."
Recent Abeona Operating Highlights
On May 17, 2016, Abeona announced that the first patient in its Phase 1/2 trial for ABO-102 (AAV-SGSH), a single treatment gene therapy strategy for patients with Sanfilippo syndrome type A (MPS IIIA), has been enrolled at Nationwide Children’s Hospital in Columbus, Ohio.
On May 24, 2016, Abeona announced the FDA Allowance of its Investigational New Drug (IND) for a Phase 1/2 clinical study with ABO-101 (AAV-NAGLU) for patients with Sanfilippo syndrome type B (MPS IIIB).
On August 2, 2016, Abeona provided an update on the initial subjects enrolled in this trial, stating that ABO-102 had been well tolerated with no safety or tolerability concerns identified through 30-days post-injection, and that encouraging signs of early biopotency had been observed in urinary and CSF GAG (heparan sulfate) measurements as well as potential disease-modifying effects in the liver and spleen.
On August 4, 2016, the Company announced it had received European regulatory approval by the Agencia Espanola de Medicamentos y Productos Sanitarios for its Phase 1/2 trial for ABO-102 (AAV-SGSH) to be conducted at Cruces University Hospital (Bilbao, Spain).
On August 9, 2016, Abeona announced a collaboration with the EB Research Partnership, EB Medical Research Foundation and Stanford University for the development of treatments for recessive dystrophic epidermolysis bullosa (RDEB). Clinical results for the lead EB program (EB-101) were recently presented at the opening Plenary Session of the Society for Investigative Dermatology in May 2016, and Investigators at Stanford are recruiting patients for a Phase 2 clinical trial of EB-101 in adolescents age 13 and older to determine the effect of type VII collagen gene corrective grafts on wound healing efficacy.
Second Quarter Summary Financial Results
Cash Position : Cash, cash equivalents and marketable securities as of June 30, 2016 were $34.3 million, compared to $37.4 million as of March 31, 2016. Net cash used in operating activities in the Six Months Ended June 30, 2016 was $5.6 million as compared to $5.0 million in the same period in 2015, an increase of $0.6 million.
Revenues : Revenues were $214 thousand for the second quarter of 2016, compared to $282 thousand in in the second quarter of 2015. Revenues consisted of a combination of royalties from marketed products, primarily MuGard, and recognition of deferred revenues related to upfront payments from early license agreements.
Loss per share : Loss per share was $0.20 for the second quarter of 2016, compared to a loss per share of $0.16 in comparable period in 2015.