Successful Type B meeting with U.S. FDA; Transpher A study will serve as the pivotal study for ABO-102 in MPS IIIA; Alignment with FDA on primary study endpoint
Focusing resources on completing EB-101 and ABO-102 pivotal, registration-enabling studies
Conference call scheduled for Thursday, July 29, 2021 at 8:30 a.m. ET
NEW YORK and CLEVELAND, July 28, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the second quarter 2021 and recent business progress.
"The second quarter was a highly effective and productive quarter for Abeona, and we remain committed to delivering operational excellence and bringing our gene therapies to patients with no approved treatments," said Michael Amoroso, Chief Executive Officer of Abeona. "As we continue to advance our clinical programs, we are delivering on meaningful milestones. We are focusing our resources on completing registration-enabling studies for patients with RDEB and MPS IIIA, and are preparing for the potential of two BLA filings."
Second Quarter and Recent Highlights
EB-101 (Autologous, Gene-Corrected Cell Therapy)
ABO-102 and ABO-101 (AAV-based Gene Therapies)
Second Quarter Financial Results
Cash, cash equivalents and short-term investments totaled $77.6 million as of June 30, 2021, compared to $86.8 million as of March 31, 2021. Net cash used in operating activities was $11.5 million for the second quarter of 2021.
"While pursuing our key strategic priorities, we have thoughtfully and carefully managed our spending decisions. Across the organization, there is a balanced approach to not only focusing on moving towards our key milestones, but also utilizing our cash resources prudently and on time to deliver results," said Edward Carr, Chief Accounting Officer of Abeona.
Total research and development (R&D) spending was $7.4 million for the second quarter of 2021, which is consistent with the $7.2 million spent in the first quarter of 2021. R&D expenses include the cost of clinical development of the EB-101 and MPS programs, manufacturing of the drug products for EB-101 and ABO-102, and preclinical ophthalmic research activities. Total general and administrative (G&A) spending was $5.5 million in the second quarter of 2021, down from the $6.6 million spent in the first quarter of 2021. The decrease in G&A in the second quarter of 2021 is primarily due to lower professional fees. Net loss was $15.2 million for the second quarter of 2021.
Conference Call Details
Abeona Therapeutics will host a conference call and webcast on Thursday, July 29, 2021 at 8:30 a.m. ET, to discuss its second quarter 2021 financial results and business update. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 7184522 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.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its investigational autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel investigational AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. Abeona's fully integrated gene and cell therapy cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and planned commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as "may," "will," "believe," "estimate," "expect," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks disclosed in the Company's most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q and other periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
|Abeona Therapeutics Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|For the three months ended June 30,||For the six months ended June 30,|
|Research and development||7,434,000||6,109,000||14,646,000||12,927,000|
|General and administrative||5,457,000||5,538,000||12,025,000||11,950,000|
|Depreciation and amortization||824,000||834,000||1,641,000||2,899,000|
|Licensed technology impairment charge||-||-||-||32,916,000|
|Loss from operations||(13,715,000||)||(12,481,000||)||(28,312,000||)||(60,692,000||)|
|Interest and miscellaneous income||8,000||271,000||23,000||923,000|
|Basic and diluted loss per common share||$||(0.16||)||$||(0.14||)||$||(0.33||)||$||(0.66||)|
|Weighted average number of common|
|shares outstanding - basic and diluted||96,509,783||92,704,203||95,378,503||92,533,354|
|Other comprehensive (loss)/income:|
|Change in unrealized (losses)/gains related to available-for-sale debt securities||(4,000||)||(253,000||)||9,000||133,000|
|Abeona Therapeutics Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||27,179,000||$||12,596,000|
|Prepaid expenses and other current assets||1,321,000||2,708,000|
|Total current assets||78,880,000||97,742,000|
|Property and equipment, net||10,240,000||11,322,000|
|Right-of-use lease assets||6,489,000||7,032,000|
|Licensed technology, net||1,442,000||1,500,000|
|Other assets and restricted cash||1,158,000||1,136,000|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current portion of lease liability||1,720,000||1,713,000|
|Current portion of loan payable||1,758,000||330,000|
|Payable to licensor||34,434,000||31,515,000|
|Total current liabilities||41,867,000||41,959,000|
|Long-term lease liabilities||4,722,000||5,260,000|
|Commitments and contingencies||-||-|
|Common stock - $0.01 par value; authorized 200,000,000 shares;|
|issued and outstanding 101,251,023 at June 30, 2021;|
|issued and outstanding 96,131,678 at December 31, 2020||1,013,000||961,000|
|Additional paid-in capital||684,987,000||672,304,000|
|Accumulated other comprehensive loss||(1,000||)||(10,000||)|
|Total stockholders' equity||84,086,000||102,551,000|
|Total liabilities and stockholders' equity||$||130,675,000||$||151,198,000|
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