On August 9, 2018 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported financial results for the second quarter of 2018 (Press release, Abeona Therapeutics, AUG 9, 2018, View Source [SID1234528779]). The Company will host a call to update investors on recent clinical developments and quarter financial results on Friday, August 10th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll-free domestic) or 201-689-8049 (International) or via webcast View Source

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"The second quarter was marked by continued progress in our clinical, pre-clinical and corporate initiatives," stated Carsten Thiel, Ph.D., Abeona’s CEO. "The strength of our lead programs, which continue to demonstrate robust and durable clinical effects, is underscored by the achievement of additional regulatory designations and the recent appointment of key executives and Board members. Notably, the opening of our in-house GMP manufacturing facility in Cleveland reinforces Abeona’s ongoing commitment to transforming patients’ lives and bolsters our position for commercial readiness."

2nd Quarter Summary Financial Results:

·Cash position: Cash, cash equivalents and marketable securities as of June 30, 2018 were $120 million, compared to $132 million as of March 31, 2018.
·Revenues: Revenues were $819 thousand for the second quarter of 2018, compared to $217 thousand in the second quarter of 2017. A portion of the increased quarterly revenues consisted of the recognition of Foundation grants that were announced during the fourth quarter of 2017. A portion of the grants were received in the second quarter of 2018, and the amount recognized is matched against corresponding expenditures for drug manufacture and clinical readiness. Additional revenues consisted of royalties from marketed products, primarily MuGard.
Loss per share: Loss per share was $0.25 for the second quarter of 2018, compared to a loss per share of $0.21 in the comparable period in 2017.

Abeona Recent Highlights:

July 26, 2018: Announced Leadership Appointments with Max Colao as Chief Commercial Officer
May 31, 2018: Announced Opening of Commercial Gene & Cell Therapy Manufacturing Facility in Ohio
May 18, 2018: Reported Update on MPS IIIA Gene Therapy Trial at the 21st Annual ASGCT (Free ASGCT Whitepaper) Meeting
ABO-102 18-month efficacy and safety data continue to demonstrate time- and dose-dependent reductions in underlying disease pathology, including decreased CSF and urine GAGs and improved liver volumes
11 subjects enrolled through > 4,200 days cumulative follow up
May 17, 2018: Reported Update from EB-101 Gene Therapy in Epidermolysis Bullosa at 21st Annual ASGCT (Free ASGCT Whitepaper) Meeting
Phase 1/2 study update results confirm EB-101 is safe and well-tolerated, with durable efficacy throughout various timepoints post-administration

Collagen VII (C7) expression: C7 and morphologically normal NC2 reactive anchoring fibrils were observed as early as one month in EB-101 treated wounds and have remained up to three years post-administration.
Wound healing, defined as >50% closure after EB-101 administration, was observed in:
100% (42/42 treated wounds, n=7 subjects) at 3 months;
90% (38/42 treated wounds, n=7 subjects) at 6 months;
67% (24/36 treated wounds, n=6 subjects) at 12 months;
88% (21/24 treated wounds, n=4 subjects) at 24 months; and
100% (6/6 treated wounds, n=1 subject) at 36 months post-administration.
May 14, 2018: Announced Appointment of Stefano Buono and Richard Van Duyne to its Board of Directors
April 23, 2018: Announced FDA Grants RMAT Designation to ABO-102 Gene Therapy in MPS IIIA
April 20, 2018: Announced EMA Grants Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease
April 2, 2018: Announced Appointment of Carsten Thiel, Ph.D., as Chief Executive Officer

"As we advance towards becoming a key player in the development of novel breakthrough gene and cell therapies for rare genetic diseases, 2018 continues to be a year of execution for Abeona," stated Steven H. Rouhandeh, Abeona’s Executive Chairman