Abeona Therapeut Stock Price, News & Analysis

Abeona Therapeutics (Nasdaq: ABEO) has appointed two new independent members to its Board of Directors: Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD. Dr. Zeiher brings over 20 years of drug development experience, having overseen the approval of 15 new treatments for serious diseases. Dr. Crombez, currently Chief Medical Officer at Ultragenyx Pharmaceutical, offers extensive expertise in clinical development programs for rare genetic disorders.

The appointments come at a important time for Abeona as it focuses on bringing pz-cel to patients with recessive dystrophic epidermolysis bullosa and seeks to advance its pipeline. Both new board members bring diverse drug development expertise that could prove valuable for Abeona's future strategies and growth.

Abeona Therapeutics (Nasdaq: ABEO) announced favorable Medicare reimbursement decisions for its investigational gene therapy, pz-cel, for recessive dystrophic epidermolysis bullosa (RDEB). The Centers for Medicare and Medicaid Services (CMS) granted a product-specific procedure code ICD-10-PCS and assigned Medicare reimbursement to Pre-MDC MS-DRG 018, one of the highest inpatient hospital reimbursement levels for cell and gene therapies. Both codes will be effective from October 1, 2024.

These decisions are expected to simplify inpatient hospital billing across all payers and increase speed to access of pz-cel after potential FDA approval. Abeona's Chief Commercial Officer, Madhav Vasanthavada, expressed confidence in securing strong access and reimbursement for all RDEB patients, citing positive feedback from commercial payers as well.

Abeona Therapeutics (NASDAQ: ABEO) reported Q2 2024 financial results and progress on its pz-cel BLA resubmission for RDEB treatment. Key points:

1. Completed Type A meeting with FDA, addressing most CRL deficiencies.
2. BLA resubmission on track for 2H 2024.
3. Q2 financials: $123M cash position, $7.4M net income.
4. Cash runway into 2026, excluding potential pz-cel revenue.
5. R&D expenses: $9.2M, G&A expenses: $8.6M.
6. New long-term safety data presented at SID and SPD meetings.
7. Non-exclusive agreement with Beacon Therapeutics for AAV204 capsid evaluation.

Abeona continues commercial preparations for potential pz-cel launch.

Abeona Therapeutics (Nasdaq: ABEO) has announced new employee inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4). On July 31, 2024, the company's Compensation Committee approved restricted stock equity awards for two new non-executive employees. These awards total up to 4,500 restricted shares of Abeona common stock. The vesting schedule for these awards is as follows:

- One-third of the shares will vest yearly on each anniversary of the Grant Date
- Full vesting will occur on the third anniversary of the Grant Date
- Vesting is subject to continued employment with Abeona on the applicable dates

These equity awards are designed to serve as a material inducement for employment at Abeona Therapeutics.

Abeona Therapeutics (Nasdaq: ABEO) and Beacon Therapeutics have signed a non-exclusive agreement for Beacon to evaluate Abeona's AAV204 capsid for ophthalmology gene therapies. AAV204, part of Abeona's AIM™ capsid library, shows promising transduction levels in macular and optic nerve tissues. Beacon has a 12-month evaluation period with options for a worldwide license covering up to five gene targets. Abeona stands to receive upfront payments, milestone payments, and royalties on net sales of licensed products. Beacon will handle development and commercialization of the therapies, which address distinct targets from Abeona's current projects.

Abeona Therapeutics (Nasdaq: ABEO) will participate in the Stifel Virtual Cell Therapy Forum on July 9, 2024. The company's CEO, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will engage in a virtual fireside chat at 9:45 a.m. Eastern Time.

A live webcast of the discussion will be accessible on the Investors section of Abeona's website under the 'Events' tab. The webcast will also be archived for 30 days for later viewing.

Abeona Therapeutics (Nasdaq: ABEO) announced the issuance of new equity awards to recently hired non-executive employees.

The grants, sanctioned under Nasdaq Listing Rule 5635(c)(4), were approved by Abeona's Compensation Committee on May 31, 2024.

A total of 5,500 restricted shares of Abeona common stock were allocated across three new hires as an employment inducement.

The vesting schedule for these shares is set over three years, with one-third vesting on each anniversary of the grant date, contingent upon continuous employment with Abeona.

Abeona Therapeutics announced its senior management will be participating in the Jefferies Global Healthcare Conference on June 6, 2024. The event will feature a fireside chat at 11:30 a.m. Eastern Time and one-on-one investor meetings. A live webcast of the chat will be available on the company's investor section, remaining accessible for 30 days.

Abeona Therapeutics (Nasdaq: ABEO) reported financial results for Q1 2024 and recent corporate progress. A significant highlight is the recent $75 million underwritten securities offering, extending the cash runway into 2026.

In April 2024, the FDA issued a Complete Response Letter (CRL) for their BLA for prademagene zamikeracel (pz-cel) for RDEB, citing the need for additional CMC information. However, no deficiencies were noted in clinical efficacy or safety data. The resubmission of the BLA is expected in the second half of 2024.

Financially, Abeona reported a net loss of $31.6 million for Q1 2024, an increase from $9.1 million in Q1 2023. R&D expenses decreased slightly while G&A expenses increased compared to the same period last year. Cash and equivalents totaled $62.7 million as of March 31, 2024.