Contemplated merger with Decoy Therapeutics progressing as planned; upon closing, combined company expected to accelerate clinical development of novel peptide conjugate therapeutics for treating respiratory viruses and cancer
Updates expected later this year from the MD Anderson Cancer Center (MDACC) investigator-initiated Phase 1/2 clinical trial of seclidemstat in combination with azacitidine to treat hematologic cancers
HOUSTON, March 24, 2025 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the 12 months ended December 31, 2024, and provided a business update.
Financial Highlights
Net loss for 2024 was $5.6 million, or $5.79 per share, compared with a net loss for 2023 of $12.5 million, or $30.74 per share. The 2024 net loss reflects significantly reduced research and development spending compared with the prior year.
Cash and cash equivalents were $2.4 million as of December 31, 2024, compared with $5.9 million as of December 31, 2023. The Company believes its existing cash resources are sufficient to meet its anticipated needs through the later part of the second quarter of 2025.
Additional information is available in the Form 10-K filed with the Securities and Exchange Commission (SEC) on March 21, 2025.
As announced on January 13, 2025, Salarius signed a definitive agreement under which Decoy Therapeutics Inc. (Decoy) will merge with a wholly owned subsidiary of Salarius, subject to the closing conditions set forth in the agreement. The newly formed company will be named Decoy Therapeutics. The proposed transaction, if consummated, is expected to facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT™ platform, which allows for the rapid computational design and manufacturing of innovative peptide conjugate therapeutics including rapid response to novel viral pathogens such as avian H5N1 flu. Decoy’s product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.
In addition, the combined company is expected to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate. The ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC is expected to be supported while the company evaluates strategic alternatives for seclidemstat.
“We are pleased with the progress we are making with Decoy on the business combination transaction. We believe Decoy’s IMP3ACT platform with its ability to develop novel peptide conjugate therapeutics for the treatment of respiratory viruses and cancer offers both near- and long-term value for our shareholders,” said David Arthur, President, CEO and Director of Salarius Pharmaceuticals. “As previously announced, the MDACC investigator-initiated hematologic cancer trial is active and enrolling patients, and we look forward to their clinical trial updates later this year.”
About Decoy Therapeutics, Inc.
Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and gastrointestinal cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program. The company has also received QuickFire Challenge award funding provided by the Biomedical Advanced Research and Development Authority (BARDA) through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation (JLABS) and BARDA within the Administration for Strategic Preparedness and Response. For more information, please visit www.DecoyTx.com.
About Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MDACC as a potential treatment for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas. For more information, please visit www.salariuspharma.com.
About the Proposed Transaction
Definitive agreements were executed with unanimous approvals by the Boards of Directors of Salarius and Decoy. The closing consideration will consist primarily of nonvoting preferred stock of Salarius, and it is expected that following closing and a post-closing stockholder vote to approve the conversion of the preferred shares into common stock, Decoy investors would own approximately 86% of the outstanding shares of the merged company and Salarius stockholders would own approximately 14% of the outstanding shares, subject to adjustment, in each case exclusive of any shares issued in any financing, including the qualifying financing(s) necessary to consummate the merger transaction. For further details on the transaction and conditions for closing of the merger, please refer to the Form 8-K Salarius filed with the SEC in conjunction with this press release at www.sec.gov.
Non-Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No public offer of securities in connection with the merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Salarius, Decoy, the proposed merger and other matters, including without limitation, statements relating to the expected ownership percentages of the combined company and plans and expectations relating to the business, products, including expected achievement of milestones for its lead asset and future prospects of Decoy and the combined company. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Salarius, as well as assumptions made by, and information currently available to, management. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” and similar terms or expressions or the negative thereof. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the closing conditions are not satisfied, including uncertainties as to the timing of the consummation of the proposed merger; the ability of each of Salarius and Decoy to consummate the merger; risks related to Salarius’ ability to estimate and manage its operating expenses and its expenses associated with the proposed merger pending the closing; risks that the combined company will not achieve the synergies expected from the proposed merger; risks that Salarius and the combined company will not obtain sufficient financing to execute on their business plans and risks related to Decoy’s products and development plans including unanticipated issues with any investigational new drug application process. Readers are urged to carefully review and consider the various disclosures made by Salarius in its reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, Salarius’ actual results may vary materially from those expected or projected. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
Business Development: Peter Marschel, CBO Peter@Decoytx.com 617-943-6305
SALARIUS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
2,434,528
$
5,899,910
Prepaid expenses and other current assets
553,034
619,763
Total current assets
2,987,562
6,519,673
Other assets
35,412
66,850
Total assets
$
3,022,974
$
6,586,523
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable
$
936,994
$
602,853
Accrued expenses and other current liabilities
352,419
406,745
Notes payable
221,866
289,643
Total liabilities
$
1,511,279
$
1,299,241
Commitments and contingencies
Stockholders' equity (deficit):
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued or outstanding
—
—
Common stock, $0.0001 par value; 100,000,000 shares authorized; 1,441,157 and 492,304 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively
144
49
Additional paid-in capital
83,435,169
81,635,074
Accumulated deficit
(81,923,618
)
(76,347,841
)
Total stockholders' equity
1,511,695
5,287,282
Total liabilities and stockholders' equity
$
3,022,974
$
6,586,523
SALARIUS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
12 Months Ended December 31,
2024
2023
Operating expenses:
Research and development
770,027
7,173,747
General and administrative
4,964,289
5,721,197
Total operating expenses
5,734,316
12,894,944
Loss before other income (expense)
(5,734,316
)
(12,894,944
)
Interest income
158,539
352,251
Net loss
$
(5,575,777
)
$
(12,542,693
)
Loss attributable to common stockholders
$
(5,575,777
)
$
(12,542,693
)
Loss per common share — basic and diluted
$
(5.79
)
$
(30.74
)
Total net loss per share
$
(5.79
)
$
(30.74
)
Weighted-average number of common shares outstanding — basic and diluted
