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Fortress Biotech (FBIO) has initiated dosing in a Phase 2 clinical trial evaluating Triplex, a cytomegalovirus (CMV) vaccine, in stem cell donors. The trial aims to reduce CMV events in patients undergoing hematopoietic stem cell transplantation (HSCT).
The multicenter, placebo-controlled study is funded by the National Cancer Institute and builds upon encouraging pilot study results. Triplex works by inducing CMV-specific immune responses in donors, which is then transferred to transplant recipients through adoptive immunity.
CMV reactivation affects 60-70% of CMV-seropositive HSCT recipients, with primary infection occurring in 20-30% of CMV-seronegative recipients. The trial is being conducted across three major transplant centers in the United States. A second NCI-funded trial is planned for higher-risk transplant recipients with partial HLA matches.
Fortress Biotech and its subsidiary Cyprium Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, a rare pediatric condition. The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2025.
In December 2023, Sentynl Therapeutics assumed responsibility for the development and commercialization of CUTX-101. Cyprium will receive royalties and up to $129 million in aggregate development and sales milestones, and retains ownership of any Priority Review Voucher issued upon NDA approval.
The NDA submission is supported by positive clinical efficacy results, showing a nearly 80% reduction in the risk of death for early-treated Menkes disease patients compared to untreated controls. Median overall survival was 177.1 months for the treated cohort versus 16.1 months for the control group. CUTX-101 has previously received multiple FDA designations, including Breakthrough Therapy and Orphan Drug.
If approved, CUTX-101 could become the first FDA-approved treatment for Menkes disease.
Fortress Biotech reported Q3 2024 financial results and highlights, including FDA approval of Emrosi for adult rosacea treatment. The company has an upcoming PDUFA date of December 28, 2024, for cosibelimab in treating advanced skin cancer. Q3 net revenue was $14.6 million from dermatology products, compared to $34.8 million in Q3 2023. Cash position stood at $58.9 million as of September 30, 2024. The company reported a net loss of $(15.0) million or $(0.76) per share. The board paused preferred stock dividends to maintain financial flexibility.
Fortress Biotech, a biopharmaceutical company focused on acquiring and advancing assets, announced its participation in two upcoming investor conferences in October 2024. Lindsay A. Rosenwald, M.D., the company's Chairman, President, and CEO, will represent Fortress at these events:
1. Lytham Partners Fall 2024 Investor Conference on October 1, 2024, at 4:15 p.m. ET. This virtual event will feature a fireside chat and 1x1 meetings.
2. 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York, consisting of 1x1 meetings.
A replay of the Lytham Partners fireside chat will be available on Fortress Biotech's website for approximately 30 days after the event.
Fortress Biotech (Nasdaq: FBIO) has announced a registered direct offering and concurrent private placements totaling approximately $8 million in gross proceeds. The company will issue 3,939,394 shares of common stock (or pre-funded warrants) at $1.65 per share to healthcare-focused institutional investors, along with warrants to purchase an additional 3,939,394 shares at $1.84 per share. In a separate private placement, the company's Chairman, CEO, and President purchased 763,359 shares at $1.84 per share and warrants for the same number of shares.
The offerings are expected to close around September 23, 2024. Fortress Biotech plans to use the net proceeds for operations, including research and development, clinical trials, and working capital. A.G.P./Alliance Global Partners is acting as the sole placement agent for the offerings.
Fortress Biotech (Nasdaq: FBIO), an innovative biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Lindsay A. Rosenwald, M.D., the company's Chairman, President, and CEO, will present a corporate overview at the event. The presentation will be available for on-demand viewing by conference attendees starting on September 9, 2024, at 7:00 a.m. ET.
Fortress Biotech focuses on acquiring and advancing assets to enhance long-term shareholder value through various revenue streams, including product revenue, equity holdings, and dividend and royalty revenue. The company will also participate in one-on-one meetings during the conference, providing an opportunity for more in-depth discussions with investors and industry professionals.
Fortress Biotech (Nasdaq: FBIO) reported Q2 2024 financial results and corporate highlights. Key points include:
1. FDA acceptance of NDA for DFD-29 (rosacea treatment) with PDUFA date of November 4, 2024.
2. FDA acceptance of BLA resubmission for cosibelimab (cSCC treatment) with PDUFA date of December 28, 2024.
3. Q2 2024 product revenue of $14.9 million, up 15% from Q1 2024.
4. Cash position of $76.2 million as of June 30, 2024.
5. Net loss of $(13.3) million, or $(0.73) per share for Q2 2024.
6. R&D expenses decreased to $12.7 million in Q2 2024 from $32.1 million in Q2 2023.
7. New loan agreement with Oaktree Capital Management, resulting in a net $15 million debt reduction.
Fortress Biotech (Nasdaq: FBIO) has entered into a new loan agreement with Oaktree Capital Management for up to $50 million, receiving an initial $35 million tranche. This arrangement allows Fortress to repay its prior $50 million loan due in August 2025 and extends the maturity to July 2027. The new loan has a 30-month interest-only period with an interest rate of 3-month SOFR plus 7.625%.
The company expects this agreement to provide financial flexibility for long-term expansion, asset acquisition, and execution of its commercial business and late-stage pipeline. Fortress anticipates up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing by 2025. This strategic partnership with Oaktree supports Fortress' ability to develop innovative assets addressing areas of high unmet medical need.
Fortress Biotech (Nasdaq: FBIO; FBIOP) announced a pause in dividend payments on its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, effective July 1, 2024. This decision affects the dividend payment scheduled for July 31, 2024, and will defer around $0.7 million in monthly cash payments. The dividends will continue to accrue until further notice. The Board will regularly review this decision, considering the company’s profitability and cash flow. This move aims to maintain financial flexibility ahead of significant regulatory milestones, including potential approvals for DFD-29, cosibelimab, and CUTX-101 within the next 12 months.
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