Financial Performance and Cash Position - The company reported cash, cash equivalents, short-term investments, and restricted cash totaling $123.0 million as of June 30, 2024, up from $62.7 million as of March 31, 2024[5] - Net cash used in operating activities was $12.7 million for the three months ended June 30, 2024[5] - Net income for Q2 2024 was $7.4 million, including a $24.9 million gain from the remeasurement of warrant liabilities, compared to a net loss of $16.7 million in Q2 2023[6] - Cash and cash equivalents increased to $34.426 million from $14.473 million, a 138% increase[14] - Short-term investments rose to $88.282 million from $37.753 million, a 134% increase[14] - Total current assets grew to $125.904 million from $55.737 million, a 126% increase[14] - Total assets increased to $134.003 million from $64.002 million, a 109% increase[14] - Total stockholders' equity rose to $73.241 million from $14.826 million, a 394% increase[14] - Additional paid-in capital grew to $846.654 million from $764.151 million, an 11% increase[14] - Accumulated deficit increased to $(773.696) million from $(749.524) million, a 3% increase[14] Expenses and Investments - Research and development expenses increased to $9.2 million in Q2 2024, compared to $8.5 million in the same period of 2023[6] - General and administrative expenses rose to $8.6 million in Q2 2024, primarily due to commercial and launch preparation costs, up from $5.0 million in Q2 2023[6] - Abeona closed a $75 million underwritten securities offering in May 2024, with participation from new and existing investors[4] - The company estimates its current cash resources, including a $50 million credit facility, are sufficient to fund operations into 2026[5] Product Development and Regulatory Updates - Abeona Therapeutics expects to resubmit the Biologics License Application (BLA) for pz-cel in the second half of 2024, with FDA alignment on CMC items[1][2] - Long-term safety data for pz-cel with up to 11 years of follow-up were presented at the Society for Investigative Dermatology Annual Meeting in May 2024[3] - Abeona entered a non-exclusive agreement with Beacon Therapeutics in July 2024 to evaluate its AAV204 capsid for ophthalmology gene therapies[4] Debt and Liabilities - Long-term debt was reported at $16.133 million, up from $0 in the previous period[14] - Warrant liabilities decreased to $24.100 million from $31.352 million, a 23% decrease[14] Shareholder Equity and Stock Issuance - Common stock shares issued and outstanding increased to 41,661,993 from 26,523,878, a 57% increase[14]

Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2024 and recent corporate progress. “Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License A ...

CLEVELAND, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On July 31, 2024, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to two individuals hired by Abeona, which equity awards relate to, in the aggregate, up to ...

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential gene therapies for select ophthalmology indications. "This agreement with Beacon under ...

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential gene therapies for select ophthalmology indications. “This agreement with Beacon unde ...

CLEVELAND, July 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time. A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at https://investors.abe ...

CLEVELAND, July 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Abeona’s Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time. A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at https://investors.ab ...

CLEVELAND, May 28, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that members of its senior management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m. Eastern Time. The Company will also participate in one-on-one investor meetings at the conference. A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at https://investors.abeonatherap ...

NEW YORK, May 16, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ: ABEO). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Abeona and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.[Click here for information about joining the class action]On April 22, 2024, Abe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-15771 ABEONA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 83-0221517 (State or other jurisdic ...