Core Viewpoint - Salarius Pharmaceuticals, Inc. will implement a 1-for-15 reverse stock split to regain compliance with Nasdaq's minimum closing bid price requirement of $1.00 [2][4]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 5:00 p.m. Eastern Time on August 15, 2025, with trading on a split-adjusted basis starting August 18, 2025 [1]. - The number of shares outstanding will decrease from approximately 7.6 million to about 509,000 shares [4]. - All outstanding options and warrants will be adjusted accordingly, and stockholders will receive cash for any fractional shares based on the closing price on August 15, 2025 [4][5]. Group 2: Approval Process - Stockholders approved the reverse stock split proposal at a special meeting on July 8, 2025, allowing the Board of Directors to determine the split ratio [3]. - The specific 1-for-15 ratio was subsequently approved by the Board of Directors [3]. Group 3: Company Overview - Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing cancer therapies, with two drug candidates: seclidemstat and SP-3164 [7]. - Seclidemstat is being studied in a Phase 1/2 clinical trial for hematologic cancers, while SP-3164 is an oral small molecule protein degrader [7].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) Delaware 46-5087339 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-36812 SALARIUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCH ...

Core Insights - Salarius Pharmaceuticals is advancing its Phase 1/2 clinical study of seclidemstat for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) with updates expected later this year [1][2] - The company is progressing with its planned merger with Decoy Therapeutics, which is anticipated to create value through Decoy's innovative peptide conjugate therapeutics platform [2][3] Company Developments - Salarius' seclidemstat is a first-in-class, orally bioavailable LSD1 inhibitor being evaluated at MD Anderson Cancer Center [1][9] - The merger with Decoy Therapeutics is set to create a new entity named Decoy Therapeutics, with Decoy investors expected to own approximately 92.4% of the merged company [2][10] - The combined company will focus on developing peptide conjugate therapeutics for unmet medical needs in respiratory infectious diseases and gastroenterology oncology [3][8] Research Insights - Recent animal studies published highlight the importance of inhibiting LSD1 expression, supporting the potential of SP-2577 in cancer treatment [2][5] - The studies provide insights into the role of KDM1A in regulating neural stem cell fate and its implications in oral squamous cell carcinoma progression [5][6] Future Plans - Decoy Therapeutics plans to advance its lead asset, a pan-coronavirus antiviral, towards an Investigational New Drug (IND) application with the FDA within the next 12 months [6][7] - The ongoing clinical trial at MDACC is expected to report data on patients with MDS and CMML who have previously failed or relapsed after hypomethylating agent therapy [7][9]

Core Insights - Salarius Pharmaceuticals is advancing its Phase 1/2 clinical study of seclidemstat for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) with updates expected later this year [1][2] - The company is progressing with its planned merger with Decoy Therapeutics, which is anticipated to create value through Decoy's innovative peptide conjugate therapeutics [2][3] Company Developments - Salarius' seclidemstat is a first-in-class, orally bioavailable LSD1 inhibitor being evaluated at MD Anderson Cancer Center [1][9] - The merger with Decoy Therapeutics is set to combine Salarius' drug candidates with Decoy's IMPACT™ platform, which focuses on developing therapeutics for respiratory viruses and cancer [3][10] - The combined company will be led by Decoy's executive team, including CEO Frederick "Rick" Pierce and CSO Barbara Hibner [4] Research Insights - Two recent animal studies highlight the importance of inhibiting LSD1 expression, supporting the potential of SP-2577 in cancer treatment [2][5] - The studies published in peer-reviewed journals provide insights into the role of KDM1A in regulating neural stem cells and oral squamous cell carcinoma progression [5] Future Plans - Decoy plans to advance its lead asset, a pan-coronavirus antiviral, towards an Investigational New Drug (IND) application with the FDA within the next 12 months [6] - The ongoing clinical trial at MDACC may yield data on MDS and CMML patients who have previously failed or relapsed after hypomethylating agent therapy [7]

[PART I. Financial Information](index=5&type=section&id=PART%20I.%20Financial%20Information) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a $1.7 million net loss and a severe decline in stockholders' equity, raising substantial doubt about its going concern status [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's balance sheet reflects a sharp deterioration in financial health, with total assets decreasing and liabilities increasing significantly Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,798,380 | $2,434,528 | | Total current assets | $2,305,086 | $2,987,562 | | Total assets | $2,339,392 | $3,022,974 | | Total liabilities | $2,277,526 | $1,511,279 | | Total stockholders' equity | $61,866 | $1,511,695 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss remained stable at $1.7 million as decreased R&D expenses were offset by higher G&A costs Three Months Ended March 31 (Unaudited) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $75,532 | $243,002 | | General and administrative | $1,643,163 | $1,528,613 | | Total operating expenses | $1,718,695 | $1,771,615 | | Net loss | $(1,709,533) | $(1,715,290) | | Loss per common share | $(1.03) | $(3.27) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased, and financing activities provided cash, resulting in a smaller net decrease in cash reserves Cash Flow Summary for Three Months Ended March 31 (Unaudited) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,181,714) | $(1,353,955) | | Net cash (used in) provided by financing activities | $545,566 | $(172,750) | | Net decrease in cash and cash equivalents | $(636,148) | $(1,526,705) | | Cash, cash equivalents at end of period | $1,798,380 | $4,373,205 | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity collapsed to just $61,866 due to a significant net loss that outpaced funds raised from equity issuance - The company's **total stockholders' equity decreased to $61,866** as of March 31, 2025, down from $1,511,695 at December 31, 2024[25](index=25&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight substantial going concern doubt, a pending merger with Decoy Therapeutics, and recent Nasdaq delisting notices - The company has entered into a merger agreement with Decoy Therapeutics, which is contingent upon certain conditions, including a **Qualified Financing of at least $6.0 million**[32](index=32&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern**, as existing cash is insufficient to fund operations for one year[33](index=33&type=chunk)[34](index=34&type=chunk) - In March and April 2025, the company received **delisting notices from Nasdaq** for failing to meet the minimum stockholders' equity requirement of $2.5 million and the minimum bid price of $1.00 per share[83](index=83&type=chunk)[84](index=84&type=chunk)[86](index=86&type=chunk) - During Q1 2025, the company sold common stock through an "at the market offering" (ATM) for gross proceeds of $0.4 million and under an Equity Line of Credit (ELOC) agreement for proceeds of $0.7 million[63](index=63&type=chunk)[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's critical financial condition, dependency on the Decoy merger, and operational results - The company's cash and cash equivalents of **$1.8 million** as of March 31, 2025, are only sufficient to fund operations into the later part of Q2 2025, raising **substantial doubt about its ability to continue as a going concern**[92](index=92&type=chunk)[117](index=117&type=chunk) - On January 10, 2025, Salarius entered into a merger agreement with Decoy Therapeutics, where legacy stockholders would own approximately **14.1%** and Decoy's stockholders would own **85.9%** of the combined company[95](index=95&type=chunk)[96](index=96&type=chunk) - If the merger with Decoy does not close, the company will likely need to **wind-down its operations** and possibly seek bankruptcy protection[94](index=94&type=chunk)[102](index=102&type=chunk)[117](index=117&type=chunk) - The decrease in R&D expenses is due to a cost-savings plan, while the increase in G&A expenses is primarily due to higher professional fees associated with the proposed merger[113](index=113&type=chunk)[115](index=115&type=chunk) Operating Expense Comparison (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $75,532 | $243,002 | $(167,470) | | General and administrative | $1,643,163 | $1,528,613 | $114,550 | [Quantitative and Qualitative Disclosures about Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Salarius Pharmaceuticals is exempt from providing market risk disclosures - The company is a **smaller reporting company** and is not required to provide quantitative and qualitative disclosures about market risk[123](index=123&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no significant changes in internal controls - Based on an evaluation as of March 31, 2025, the principal executive and financial officers concluded that the company's **disclosure controls and procedures were effective**[125](index=125&type=chunk) - There were **no significant changes** in the company's internal control over financial reporting during the first quarter of 2025[126](index=126&type=chunk) [PART II. Other Information](index=26&type=section&id=PART%20II.%20Other%20Information) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not currently involved in any material legal proceedings**[128](index=128&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Key risks include the potential failure of the Decoy merger, insufficient cash reserves, and the threat of Nasdaq delisting - If the merger and associated financing are not completed, the company will likely pursue **dissolution and liquidation**, with no assurance of any cash distribution to stockholders[130](index=130&type=chunk)[135](index=135&type=chunk) - Cash resources of **$1.8 million** are only sufficient to meet needs into the later part of Q2 2025, creating **substantial doubt about the company's ability to continue as a going concern**[132](index=132&type=chunk)[138](index=138&type=chunk) - The company's common stock is **subject to delisting from Nasdaq** due to failure to meet minimum bid price and stockholders' equity requirements[139](index=139&type=chunk)[143](index=143&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company sold $740,500 of common stock through a private placement under its ELOC agreement - Under its ELOC Agreement, the company sold 283,933 shares of common stock for an aggregate purchase price of **$740,500** between January 13, 2025, and March 7, 2025[149](index=149&type=chunk) - The securities were issued in a **private placement** to an accredited investor, relying on exemptions from registration under the Securities Act[148](index=148&type=chunk) [Defaults Upon Senior Securities](index=29&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) None [Mine Safety Disclosures](index=29&type=section&id=Item%204%20Mine%20Safety%20Disclosures) Not Applicable [Other Information](index=30&type=section&id=Item%205%20Other%20Information) None [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Merger Agreement and related officer certifications

Core Insights - Decoy Therapeutics, Inc. is set to merge with Salarius Pharmaceuticals, Inc., with the new entity retaining the name Decoy Therapeutics, following the completion of the merger [1][10] - Renowned MIT Professor Robert S. Langer will join Decoy's Scientific Advisory Board, bringing extensive expertise in drug delivery systems and tissue engineering [1][2][3] Company Overview - Decoy Therapeutics is a preclinical-stage biotechnology company focused on developing peptide-conjugate therapeutics targeting unmet medical needs, particularly in respiratory viruses and gastrointestinal cancers [8] - The company utilizes a proprietary IMP3ACT platform that integrates machine learning and AI for rapid design and synthesis of novel antiviral and cancer therapies [5][7] Scientific Advisory Board - Dr. Robert S. Langer's appointment to the Scientific Advisory Board is expected to enhance Decoy's capabilities in drug design and development, particularly in dosage forms and administration routes [3][4] - Dr. Langer's contributions to the field include pioneering work that has led to transformative medicines, such as Roche's Avastin and Moderna's Spikevax [2][4] Technology and Innovation - Decoy's IMP3ACT platform allows for the rapid computational design of peptide-conjugate drugs, which have shown effectiveness against various human coronaviruses and other viral pathogens [5][7] - The technology leverages peptide chemistry to create multimeric conjugates that improve drug-like properties and pharmacokinetics [7] Financial and Strategic Position - Decoy has secured financing from institutional investors and non-dilutive capital sources, including the Massachusetts Life Sciences Seed Fund and the Google AI startup program [8] - The merger with Salarius is structured such that Decoy investors will own approximately 86% of the merged company, while Salarius stockholders will own about 14% [10]

Core Viewpoint - Decoy Therapeutics Inc. is advancing its IMP3ACT™ platform to develop antiviral drug candidates effective against paramyxoviridae family viruses, including measles and Nipah viruses, and is merging with Salarius Pharmaceuticals to enhance its capabilities in infectious disease and oncology drug development [1][2][4]. Company Overview - Decoy Therapeutics is a preclinical-stage biotechnology company focused on designing peptide-conjugate drug candidates using machine learning (ML) and artificial intelligence (AI) [9]. - The company aims to address serious unmet medical needs, particularly in respiratory viruses and gastrointestinal cancers, and has received funding from various institutional investors and programs [9]. Technology and Platform - The IMP3ACT platform utilizes AI and ML to create peptide-conjugate therapeutics that directly target viral machinery, potentially changing the economics of antiviral drug development [2][4]. - Decoy's technology allows for rapid design and synthesis of antiviral candidates, optimizing them for various properties such as binding specificity and manufacturability [4][8]. Merger Details - Decoy and Salarius Pharmaceuticals have signed a definitive merger agreement, with Decoy investors expected to own approximately 86% of the combined company post-merger [11][12]. - The merger aims to integrate Decoy's expertise with Salarius' resources to advance a diversified pipeline of antiviral and cancer drugs [4][11]. Current Health Context - There is a rising need for new antiviral drugs due to vaccine skepticism and ongoing measles outbreaks, with over 320 cases reported in Texas and additional cases in at least 12 other states [6]. - Measles is highly contagious and can lead to severe health complications, highlighting the urgency for effective treatments [5][6].

Core Viewpoint - Salarius Pharmaceuticals is progressing with its merger with Decoy Therapeutics, which is expected to enhance the clinical development of innovative peptide conjugate therapeutics targeting respiratory viruses and cancer [1][3][5] Financial Highlights - For the year ended December 31, 2024, Salarius reported a net loss of $5.6 million, or $5.79 per share, a significant reduction from a net loss of $12.5 million, or $30.74 per share in 2023 [8][17] - Cash and cash equivalents decreased to $2.4 million as of December 31, 2024, down from $5.9 million a year earlier [8][15] - Total operating expenses for 2024 were $5.7 million, compared to $12.9 million in 2023, reflecting a substantial decrease in research and development spending [17] Merger Details - The merger with Decoy Therapeutics is structured such that Decoy investors will own approximately 86% of the combined company, while Salarius stockholders will own about 14%, subject to adjustments [10] - The merger aims to leverage Decoy's IMPACT™ platform for rapid design and manufacturing of peptide conjugate therapeutics, addressing unmet needs in respiratory infectious diseases and gastrointestinal oncology [3][4] Product Development - Salarius' lead candidate, seclidemstat, is currently in a Phase 1/2 clinical trial at MD Anderson Cancer Center for treating hematologic cancers, with updates expected later this year [1][4][5] - The combined company plans to integrate Salarius' SP-3164 into a targeted peptide-based PROTACS drug candidate [4]

Merger and Acquisition - The Merger Agreement allows for adjustments in the Exchange Ratio based on the Parent Cash Amount and Company Cash Amount, which could lead to Salarius stockholders owning approximately 14.1% of the combined company if the Parent Cash Amount is $0 and the Company Cash Amount is $2.0 million[113]. - Salarius anticipates a Parent Cash Amount of approximately $0, which may lead to additional dilution for stockholders, with a floor of 10% ownership in the combined company[115]. - The Merger may not be completed if there is a Material Adverse Effect on either Salarius or Decoy, which could negatively impact Salarius' stock price and future business[123]. - The combined company may need to raise additional capital sooner than planned, which could lead to significant dilution for stockholders and restrictive covenants on operations[130]. - If the Merger is not completed, Salarius may face liquidity issues and could consider dissolution and liquidation, impacting stockholder returns[132]. - Stockholders of both Salarius and Decoy will have reduced ownership and voting interest in the combined company following the Merger[128]. - The Merger Agreement includes provisions that may discourage third parties from submitting alternative takeover proposals, potentially limiting strategic options for Salarius[118]. - Salarius is required to recommend the conversion of all outstanding shares of its Series A Preferred Stock into Common Stock, which may not be approved by stockholders[119]. - The combined company may become involved in securities class action litigation following the Merger, which could divert management's attention and resources[122]. - The merger is expected to result in Decoy stockholders owning approximately 85.9% of the combined entity[343]. - The company has agreed to call a special stockholder meeting to approve the conversion of preferred stock into common stock and a new equity incentive plan[344]. Financial Performance - As of December 31, 2024, Salarius had cash and cash equivalents totaling $2.4 million and an accumulated deficit of $81.9 million[134]. - For the twelve months ended December 31, 2024, Salarius reported net losses of $5.5 million[134]. - Salarius' stockholders' equity was approximately $2.3 million as of June 30, 2024, and after selling 564,730 shares, it regained compliance with the Stockholders' Equity Requirement[140]. - As of December 31, 2024, Salarius had total stockholders' equity of approximately $1.5 million and did not have net income in any period during the last two fiscal years[141]. - Salarius' common stock is currently trading below the $1.00 minimum bid price requirement, risking delisting from Nasdaq[143]. - The net loss for 2024 was $5,575,777, compared to a net loss of $12,542,693 in 2023, representing a decrease in loss of approximately 55.5%[274]. - Total current assets decreased from $6,519,673 in 2023 to $2,987,562 in 2024, a decline of approximately 54.2%[272]. - Total liabilities increased from $1,299,241 in 2023 to $1,511,279 in 2024, an increase of approximately 16.3%[272]. - The total stockholders' equity decreased from $5,287,282 in 2023 to $1,511,695 in 2024, a decline of approximately 71.5%[272]. - Interest income decreased from $352,251 in 2023 to $158,539 in 2024, a decline of approximately 55.0%[274]. - The company issued equity securities netting $1,526,460 in 2024, compared to $6,920,529 in 2023, a decrease of about 78.0%[278]. - The company has suffered recurring losses from operations since its inception, with substantial doubt existing regarding its ability to fund operations through one year from the issuance date of the financial statements[291]. Operational Challenges - Salarius has never generated any revenue from product sales and does not anticipate doing so in the foreseeable future[150]. - The company may face significant costs associated with commercializing any approved product candidates, including royalty and milestone payments to third parties[151]. - Salarius' ability to maintain liquidity is uncertain, raising substantial doubt about its ability to continue as a going concern[138]. - The failure to secure necessary financing or complete the Merger could lead to delays or abandonment of future clinical development plans[135]. - Salarius currently does not have the funds to advance its planned clinical trials, which are costly and time-consuming[154]. - The successful development of Salarius' product candidates is uncertain, as clinical trials may fail to demonstrate safety and efficacy[156]. - Salarius has not received approval from regulatory authorities to market any product candidate in any jurisdiction, which could impair its ability to generate revenue[167]. - Difficulty in enrolling patients for clinical trials is a common hurdle that could delay or prevent the trials[157]. - Salarius' product candidates may cause undesirable side effects, which could delay or prevent regulatory approval[155]. - Reliance on government funding for Salarius' programs may add uncertainty to its research and commercialization efforts[168]. - Salarius currently relies on third parties for clinical trials and manufacturing, which poses risks if these parties fail to comply with regulatory requirements or provide sufficient product quality[194][196]. - The company does not have the infrastructure to manufacture its clinical supplies internally and plans to continue relying on external vendors for production[197]. - Salarius' current manufacturing costs are not commercially feasible, which could adversely affect the viability of its product candidates[198]. Intellectual Property and Regulatory Risks - Salarius relies on a combination of patents, trade secret protection, and confidentiality agreements to protect its intellectual property, which is critical for its business[174]. - The patent position of Salarius is highly uncertain, and there is no assurance that its patent applications will result in issued patents[177]. - Salarius' commercial success is dependent on its ability to develop and market product candidates without infringing third-party patents, which may delay or prevent commercialization efforts[186]. - The company is aware of numerous third-party patents in the area of epigenetic enzyme inhibitors, which could affect its ability to manufacture or market its product candidates without obtaining licenses[187]. - Salarius may not have sufficient patent term protections for its product candidates, which could expose the company to competition from generic medications after patent expiration[180]. - The company relies on patent term extensions under the Hatch-Waxman Act, but there are no assurances that such extensions will be granted or for how long[181]. - Changes in U.S. patent law and recent Supreme Court rulings have created uncertainties regarding the value and enforceability of patents, potentially impacting Salarius' ability to protect its products[183]. Capital and Funding - The company is evaluating additional capital options, including the sale of equity securities and new collaborations, but cannot assure success in these endeavors[285]. - Salarius announced a merger agreement with Decoy Therapeutics, which involves a two-step merger process, with Decoy becoming a wholly owned subsidiary of Salarius[284]. - The company implemented multiple cost-savings plans to extend its expected cash runway into the later part of the second quarter of 2025[283]. - Grants receivable balances were $0 as of December 31, 2024 and December 31, 2023, with the Company receiving $1.5 million from the Cancer Prevention and Research Institute of Texas on February 15, 2023[314]. - The Company was awarded a grant of up to $16.1 million from CPRIT for the development of LSD 1 inhibitor, which expired during 2023[316]. - The Company entered into a Securities Purchase Agreement in May 2023, raising approximately $6 million from the sale of common stock and warrants[325]. - The company has a federal net operating loss carryforward of $39.8 million with an indefinite life, while R&D credits of $3.5 million will begin to expire in 2039[336]. Stock and Shareholder Information - The weighted-average number of common shares outstanding increased from 408,078 in 2023 to 962,210 in 2024, an increase of about 135.5%[274]. - Future sales of a significant number of shares could depress the market price of Salarius' common stock, impacting its ability to raise capital[199]. - The company does not intend to pay dividends in the foreseeable future, with returns to investors expected only from potential increases in stock price[200]. - As of December 31, 2024, approximately 560,839 warrants remained outstanding, a decrease from 1,355,598 in 2023[331]. - The Company has 9,844 shares remaining available for the grant of stock options under the 2015 Equity Incentive Plan as of December 31, 2024[333]. - The company granted 21,125 stock options in 2024, with an average exercise price of $3.02, compared to 0 options in 2023[334]. - The total unrecognized compensation cost related to unvested stock options was approximately $0.1 million as of December 31, 2024, down from $0.3 million in 2023[334].

Core Insights - Salarius Pharmaceuticals has resumed patient enrollment in a Phase 1/2 clinical trial for seclidemstat combined with azacitidine, targeting myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) [1][4] - Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme, showing promising results in preclinical models by reprogramming cancer cell differentiation and reducing tumor burden [2] - Interim results from the trial indicated a 43% overall response rate among 14 higher-risk MDS and CMML patients, with a median overall survival of 18.5 months [3] Clinical Trial Updates - The trial is being conducted at the University of Texas MD Anderson Cancer Center and is listed on clinicaltrials.gov [1] - The FDA had previously placed the trial under a partial clinical hold due to a serious adverse event, which has now been lifted [4][5] Merger and Strategic Developments - Salarius has signed a definitive agreement to merge with Decoy Therapeutics, which will create a new company focused on peptide conjugate therapeutics [6] - The merger is expected to enhance value through Decoy's innovative pipeline, which addresses unmet needs in respiratory infectious diseases and gastroenterology oncology [6][9] - The combined company plans to integrate Salarius' SP-3164 into a targeted peptide-based drug candidate while continuing the development of seclidemstat [7]