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
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 ofNovember 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 inJanuary 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 . InDecember 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.
Clinical Updates
- The Phase 2 clinical trial of Triplex, a CMV vaccine, for adults co-infected with HIV and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity.
- In
May 2024 , we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation. The trial is funded by a grant from the NIH’sNational Institute of Allergy and Infectious Diseases of the (NIH /NIAID) that could provide over$20 million in non-dilutive funding. Triplex is currently in development at our subsidiary company,Helocyte, Inc. - A Phase 1b clinical trial in patients with gout and hyperuricemia is ongoing in the
U.S. to confirm the comparability ofU.S. patients’ response to dotinurad (urate transporter (URAT1) inhibitor) with data generated inJapan , and to assess drug-drug interactions, if any, with allopurinol. We expect to announce data from this trial in mid-2024. Dotinurad is currently in development at our subsidiary company,Urica Therapeutics, Inc. (“Urica”).
Commercial Product Updates
- Journey Medical’s total revenues for the first quarter ended
March 31, 2024 were$13.0 million , an increase of$0.8 million , or 7%, compared to total net revenues of$12.2 million for the first quarter endedMarch 31, 2023 .
General Corporate:
- In
January 2024 , Fortress raised gross proceeds of approximately$11.0 million in a registered direct offering priced at-the-market under Nasdaq rules. - In
January 2024 , Checkpoint raised gross proceeds of approximately$14.0 million in a registered direct offering, and Avenue raised approximately$5.0 million gross proceeds from warrant exercise transactions.
Financial Results:
- As of
March 31, 2024 , Fortress’ consolidated cash, cash equivalents and restricted cash totaled$85.8 million , compared to$83.4 million as ofDecember 31, 2023 , an increase of$2.5 million during the quarter. - Fortress’ consolidated cash, cash equivalents and restricted cash, totaling
$85.8 million as ofMarch 31, 2024 , includes$45.6 million attributable to Fortress and the private subsidiaries,$3.2 million attributable to Avenue,$11.2 million attributable to Checkpoint,$1.7 million attributable toMustang Bio and$24.1 million attributable to Journey Medical.- Fortress’ consolidated cash, cash equivalents and restricted cash, totaled
$83.4 million as ofDecember 31, 2023 , which included$42.2 million attributable to Fortress and private subsidiaries,$1.8 million attributable to Avenue,$4.9 million attributable to Checkpoint,$7.0 million attributable toMustang Bio and$27.4 million attributable to Journey Medical.
- Fortress’ consolidated cash, cash equivalents and restricted cash, totaled
- Subsequent to the end of the first quarter, in
May 2024 , Avenue raised approximately$4.4 million in gross proceeds from warrant exercise transactions and Mustang raised approximately$4.0 million in gross proceeds from a public offering of common stock and warrants. - Fortress’ consolidated net revenue totaled
$13.0 million for the first quarter endedMarch 31, 2024 , all of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling$12.4 million for the first quarter of 2023, which included$12.2 million in revenue generated from our marketed dermatology products. - Consolidated research and development expenses including license acquisitions totaled
$24.8 million for the first quarter endedMarch 31, 2024 , compared to$39.5 million for the first quarter endedMarch 31, 2023 . - Consolidated selling, general and administrative costs were
$17.9 million for the first quarter endedMarch 31, 2024 , compared to$25.3 million for the first quarter endedMarch 31, 2023 . - Consolidated net loss attributable to common stockholders was
$(17.7) million , or$(1.03) per share, for the first quarter endedMarch 31, 2024 , compared to net loss attributable to common stockholders of$(23.5) million , or$(3.47) per share for the first quarter endedMarch 31, 2023 . - All share and per share information has been retroactively adjusted to give effect to the Company’s
October 2023 1-for-15 reverse stock split for all periods presented, unless otherwise indicated.
About
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
Company Contact:
(781) 652-4500
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
Unaudited Condensed Consolidated Balance Sheets
($ in thousands except for share and per share amounts)
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, | 3 | 3 | ||||||
Common stock, | 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 of Operations
($ in thousands except for share and per share amounts)
Three Months Ended | ||||||||
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 |
1 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.
Source:
2024 GlobeNewswire, Inc., source