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Abeona Therapeutics Inc. (NASDAQ: ABEO) is a prominent clinical-stage biopharmaceutical company dedicated to the development of innovative gene therapies for life-threatening rare genetic disorders. By leveraging cutting-edge biotechnology, Abeona is making significant strides in transforming treatment paradigms for diseases with high unmet medical needs.
Core Business
Abeona's primary focus is on gene therapies and plasma-based products aimed at rare genetic diseases. The company's leading programs include pz-cel (prademagene zamikeracel, formerly known as EB-101), an investigational autologous gene-corrected epidermal graft for treating recessive dystrophic epidermolysis bullosa (RDEB), and several adeno-associated virus (AAV)-based gene therapies. These include therapies for Sanfilippo syndrome types A and B, juvenile Batten disease, infantile Batten disease, and Fanconi anemia.
Recent Achievements and Current Projects
In recent developments, Abeona completed its first U.S. Biologics License Application (BLA) submission for pz-cel in September 2023. The FDA's Priority Review of this application has a target action date of May 25, 2024. Moreover, the company has initiated commercial readiness activities, including discussions with treatment sites and payer engagements, anticipating a potential U.S. launch. Abeona's financial condition has been significantly bolstered by a $75 million underwritten offering in May 2024 and a $50 million credit facility obtained in January 2024.
Strategic Partnerships and Financial Highlights
Abeona's collaborations with institutional investors and organizations like Taysha Gene Therapies have been instrumental in advancing its clinical programs. With a robust balance sheet, the company raised an additional $25 million in July 2023 to support commercial preparations, and as of the latest financial reports, holds sufficient resources to fund operations into 2026.
Product Pipeline
Abeona's development portfolio includes:
- pz-cel for RDEB
- abo-102 for Sanfilippo syndrome type A
- abo-101 for Sanfilippo syndrome type B
- abo-201 and abo-202 for juvenile and infantile Batten disease
- abo-301 for Fanconi anemia
- abo-302 utilizing CRISPR/Cas9-based gene editing
- EB-201 for epidermolysis bullosa
Through its fully integrated cell and gene therapy cGMP manufacturing facility, Abeona is equipped to support both clinical and potential commercial production needs.
Looking Forward
With its strong pipeline and strategic financial maneuvers, Abeona Therapeutics is well-positioned to achieve critical milestones in the near future. The company remains committed to bringing transformative therapies to patients with unmet needs, driving forward its mission to change the landscape of gene therapy.
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.
Abeona Therapeutics Inc. (Nasdaq: ABEO) granted equity awards to new non-executive employees under Nasdaq Listing Rule 5635(c)(4). The Compensation Committee approved restricted stock equity awards totaling up to 37,200 shares of common stock for ten new hires. One-third of the shares will vest yearly over three years, contingent on continued employment.
Abeona Therapeutics Inc. announced the pricing of an underwritten offering of common stock and pre-funded warrants, expected to generate approximately $75 million in gross proceeds. The offering includes both new and existing investors, with the funds intended for the resubmission of its BLA, commercialization of its product candidate pz-cel, and general corporate purposes.
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