On May 13, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported financial results for the first quarter of 2022 (Press release, Abeona Therapeutics, MAY 13, 2022, View Source [SID1234614486]). The Company will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update.
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"During the quarter, we took significant steps to preserve our capital with the goal to fund operations over the next 12 months with existing cash resources," said Vish Seshadri, Chief Executive Officer of Abeona. "First, we began off-loading our MPS assets to reduce cash burn. Second, having completed accrual for the EB-101 pivotal Phase 3 VIITAL study, we are now focusing R&D resources on generating topline results in the third quarter of 2022, while aggressively exploring partnerships for commercialization of EB-101. Furthermore, we have initiated steps toward regaining compliance with Nasdaq listing requirements."
First Quarter and Recent Highlights
Completed patient enrollment in pivotal Phase 3 VIITAL study evaluating EB-101 for recessive dystrophic epidermolysis bullosa (RDEB), and anticipate topline data readout in the third quarter of 2022.
Additional long-term follow up data up to eight years and quality of life data from a completed Phase 1/2 study evaluating EB-101 for RDEB will be presented at the Society of Investigative Dermatology (SID) Annual Meeting, which will be held on May 18-21, 2022 in Portland, OR. The data will be featured in an oral presentation entitled "Long-term efficacy and safety of investigational autologous gene-corrected skin sheets (EB-101) for recessive dystrophic epidermolysis bullosa (RDEB)."
Reported non-human primate data for AAV204, a novel adeno-associated virus (AAV) capsid from Abeona’s AIM capsid library, highlighting its ability to produce more robust transduction in the macula area of the eye following para-retinal administration, which unlike subretinal administration does not create a retinal detachment. The data was featured at the Association for Research and Vision in Ophthalmology (ARVO) 2022 Annual Meeting.
Appointed Joseph Vazzano as Chief Financial Officer, who brings valuable experience while serving as the Chief Financial Officer at Avenue Therapeutics, Inc. where he secured multiple equity financings.
Nasdaq Compliance Plan
Requested a 180-calendar day extension to regain compliance with the Nasdaq Capital Market’s minimum closing bid price requirement of $1.00 per share.
As part of the Company’s strategy to regain compliance, Abeona intends to seek approval of a reverse stock split of the outstanding shares of common stock at a Special Meeting of stockholders at 10:00 am ET on June 14, 2022. Stockholders as of May 3, 2022, the record date, are entitled to attend the online Special Meeting, view the proxy statement and vote at: www.virtualshareholdermeeting.com/ABEO2022SM.
On May 2, 2022, Abeona completed a $25 million private placement offering of convertible redeemable preferred stock. Holders of the preferred stock will vote together with the Company’s common stockholders on a proposal to effect a reverse stock split of the Company’s common stock at the Special Meeting.
First Quarter Financial Results
The unaudited interim condensed consolidated financial statements for the quarter ended March 31, 2022, which were filed on Form 10-Q on May 13, 2022, have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report is issued.
Cash, cash equivalents, restricted cash and short-term investments totaled $37.2 million as of March 31, 2022. Net cash used in operating activities was $13.7 million for the three months ended March 31, 2022.
License and other revenues in the first quarter of 2022 were $0.3 million, compared to nil in the first quarter of 2021. The revenue in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the ABO-102 and ABO-101 development programs.
Research and development (R&D) expenses for the three months ended March 31, 2022 were $10.5 million, compared to $8.3 million for the same period of 2021. General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2022, compared to $6.3 million for the same period of 2021.
Net loss was $20.8 million for the first quarter of 2022, or $0.14 loss per common share as compared to a net loss of $16.0 million, or $0.17 loss per common share, in the first quarter of 2021. The net loss in the first quarter of 2022 includes $6.2 million in non-cash impairment charges resulting from the disposition of the ABO-102 and ABO-101 development programs as the Company focuses resources on its EB-101 pivotal program and preclinical eye gene therapy programs. The impairment charges have no impact on the Company’s cash position or cash flow from operating activities and do not have an impact on future operations.
Conference Call Details
Abeona Therapeutics will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 221025 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.