Full Press Release Details
Fortress Biotech Reports First Quarter 2024
Financial Results and Recent Corporate Highlights
Fortress late-stage pipeline
continues to advance and may generate up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a
fourth BLA filing as early as 2025
FDA accepted New Drug Application filing for
DFD-29 to treat inflammatory lesions and erythema of rosacea in adults; PDUFA goal date of November 4, 2024
Miami, FL - May 15, 2024 -
Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing
assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced
financial results and recent corporate highlights for the first quarter ended March 31, 2024.
Lindsay A. Rosenwald, M.D., Fortress' Chairman,
President and Chief Executive Officer, said, "We achieved first quarter year-over-year product revenue growth of 7%, which was
driven by greater than 20% year-over-year growth in our flagship products, Qbrexza and Accutane . In the
first quarter of 2024, the U.S. Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA")
filing for DFD-29 and set a Prescription Drug User Fee Act ("PDUFA") goal date of November 4, 2024. If approved, DFD-29 has
the potential to be the only oral, systemic therapy to address inflammatory lesions and erythema (redness) from rosacea, differentiating
it as a potential best-in-class solution for the millions of patients suffering from rosacea. We also dosed the first patient in a multi-center
Phase 2 study for Triplex for control of cytomegalovirus ("CMV") in patients undergoing liver transplantation and received
grant funding from the National Institutes of Health ("NIH") to further advance cell and gene therapy candidates for the
potential treatment of adults living with HIV and children with Menkes disease. Looking ahead, our expansive portfolio of development-stage
programs across multiple areas, including oncology, dermatology, and rare diseases, holds the potential for up to three NDA and Biologics
License Application ("BLA") regulatory approvals within the next 12 months and potentially a fourth BLA filing as early as
2025. Additionally, we anticipate multiple data readouts this year, including topline data from the Phase 1b/2a clinical trial of AJ201
to treat spinal and bulbar muscular atrophy ("SBMA"), data from the Phase 1b clinical trial of dotinurad for the treatment
of gout and hyperuricemia and topline Phase 2 clinical data of Triplex, a CMV vaccine for adults co-infected with HIV and CMV. This sustained
progress underscores the strength of Fortress' business model, centered on acquiring and advancing assets that address unmet medical
needs and enhance long-term value for shareholders through product revenues, equity holdings and royalties."
Recent Corporate Highlights1:
Regulatory Milestones and Updates
| In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024. We submitted the NDA to the FDA seeking approval for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults in January 2024. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator's Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical"). | ||
| The CUTX-101 rolling NDA submission is ongoing and is expected to be completed by our partner, Sentynl Therapeutics, Inc. in 2024. Cyprium, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101. | ||
| We submitted a BLA to the FDA for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation, in January 2023. In December 2023, the FDA issued a complete response letter ("CRL") for the cosibelimab BLA. The CRL solely cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturing organization as approvability issues to address in a resubmission. The CRL did not state any concerns about the clinical data package, safety or labeling for the approvability of cosibelimab. We intend to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) ("Checkpoint"). | ||
| Based on its public statements, AstraZeneca plc has estimated that it expects the FDA to accept its BLA submission of CAEL-101 (anselamimab) to treat AL amyloidosis for review as early as 2025. |
Commercial Product Updates
The development programs depicted in this press release include product candidates in development at Fortress, at Fortress' private
subsidiaries (referred to herein as "subsidiaries"), at Fortress' public subsidiaries (referred to herein as "partner
companies") and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive
license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we",
"us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies,
or to all such entities as a group, as dictated by context.
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress")
is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through
product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products
and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners
and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress' portfolio is being commercialized
and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress' model is focused on leveraging
its significant biopharmaceutical industry expertise and network to further expand and advance the company's portfolio of product
opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical
companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide
Children's Hospital and Sentynl. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
Statements in this press release that are not
descriptions of historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words "anticipates," "believes,"
"can," "continue," "could," "estimates," "expects," "intends,"
"may," "might," "plans," "potential," "predicts," "should," or
"will" or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements.
These forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that
could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results
to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements
and relationships; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire,
close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel;
the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical
and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize
products for which we receive regulatory approval; our ability to secure and maintain third-party manufacturing, marketing and distribution
of our and our partner companies' products and product candidates; government regulation; patent and intellectual property matters;
competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly
any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in
events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection
of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained
herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information
in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing
Fortress Biotech, Inc.
Media Relations Contact:
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Balance Sheets
($ in thousands except for share and per share
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 83,774 | $ | 80,927 | ||||
| Accounts receivable, net | 9,799 | 15,222 | ||||||
| Inventory | 10,580 | 10,206 | ||||||
| Other receivables - related party | 324 | 167 | ||||||
| Prepaid expenses and other current assets | 12,071 | 10,500 | ||||||
| Total current assets | 116,548 | 117,022 | ||||||
| Property, plant and equipment, net | 6,128 | 6,505 | ||||||
| Operating lease right-of-use asset, net | 16,462 | 16,990 | ||||||
| Restricted cash | 2,063 | 2,438 | ||||||
| Intangible assets, net | 19,473 | 20,287 | ||||||
| Other assets | 3,971 | 4,284 | ||||||
| Total assets | $ | 164,645 | $ | 167,526 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 76,379 | $ | 73,562 | ||||
| Income taxes payable | 843 | 843 | ||||||
| Common stock warrant liabilities | 689 | 886 | ||||||
| Operating lease liabilities, short-term | 2,601 | 2,523 | ||||||
| Partner company convertible preferred shares, short-term, net | 4,021 | 3,931 | ||||||
| Partner company installment payments - licenses, short-term, net | 3,000 | 3,000 | ||||||
| Other short-term liabilities | 163 | 163 | ||||||
| Total current liabilities | 87,696 | 84,908 | ||||||
| Notes payable, long-term, net | 61,420 | 60,856 | ||||||
| Operating lease liabilities, long-term | 17,619 | 18,282 | ||||||
| Other long-term liabilities | 1,847 | 1,893 | ||||||
| Total liabilities | 168,582 | 165,939 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity (deficit) | ||||||||
| Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share | 3 | 3 | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 19,375,343 and 15,093,053 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 19 | 15 | ||||||
| Additional paid-in-capital | 733,290 | 717,396 | ||||||
| Accumulated deficit | (710,287 | ) | (694,870 | ) | ||||
| Total stockholders' equity attributed to the Company | 23,025 | 22,544 | ||||||
| Non-controlling interests | (26,962 | ) | (20,957 | ) | ||||
| Total stockholders' equity (deficit) | (3,937 | ) | 1,587 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 164,645 | $ | 167,526 |
FORTRESS BIOTECH, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements
($ in thousands except for share and per share
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | ||||||||
| Product revenue, net | $ | 13,030 | $ | 12,165 | ||||
| Collaboration revenue | - | 181 | ||||||
| Revenue - related party | - | 35 | ||||||
| Other revenue | - | 48 | ||||||
| Net revenue | 13,030 | 12,429 | ||||||
| Operating expenses | ||||||||
| Cost of goods sold - product revenue | 6,816 | 6,449 | ||||||
| Research and development | 24,839 | 35,276 | ||||||
| Research and development - licenses acquired | - | 4,230 | ||||||
| Selling, general and administrative | 17,941 | 25,341 | ||||||
| Total operating expenses | 49,596 | 71,296 | ||||||
| Loss from operations | (36,566 | ) | (58,867 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 833 | 1,036 | ||||||
| Interest expense and financing fee | (2,602 | ) | (4,296 | ) | ||||
| Gain (loss) on common stock warrant liabilities | (667 | ) | 6,678 | |||||
| Other income (expense) | (21 | ) | 304 | |||||
| Total other income (expense) | (2,457 | ) | 3,722 | |||||
| Net loss | (39,023 | ) | (55,145 | ) | ||||
| Net loss attributable to non-controlling interests | 23,606 | 33,608 | ||||||
| Net loss attributable to Fortress | $ | (15,417 | ) | $ | (21,537 | ) | ||
| Net loss attributable to common stockholders | $ | (17,731 | ) | $ | (23,545 | ) | ||
| Net loss per common share attributable to common stockholders - basic and diluted | $ | (1.03 | ) | $ | (3.47 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 17,151,945 | 6,792,376 |