Core Insights - Salarius Pharmaceuticals announced promising clinical data for seclidemstat in treating higher-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who previously failed or relapsed after hypomethylating agent therapy, with a reported 43% overall response rate [1][6][8] Clinical Study Details - The Phase 1/2 dose-escalation study aims to evaluate the safety, tolerability, maximum tolerated dose, and overall response of seclidemstat in combination with azacitidine in adult patients with higher-risk MDS or CMML [2] - As of May 2024, 16 patients were enrolled in the study, with 14 patients evaluable for efficacy [2] - The study reported a median overall survival of 18.5 months and a median event-free survival of 7.2 months [5][6] Efficacy and Safety Results - Among the 14 evaluable patients, 6 (43%) had an objective response, including 1 complete response and 3 marrow complete responses [6] - Adverse events observed were deemed manageable, with dose-limiting toxicity noted in 1 patient in the 750mg BID cohort [3][6] Future Directions - The study will evaluate up to six dose levels of seclidemstat, with the maximum tolerated dose yet to be reached [7] - Salarius is encouraged by the early results and continues to support its clinical programs while exploring strategic alternatives to maximize shareholder value [8][9]

Core Viewpoint - Salarius Pharmaceuticals, Inc. will implement a 1-for-8 reverse stock split to comply with Nasdaq's minimum bid price requirement of $1.00, effective June 14, 2024 [1][7]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 4.7 million to about 0.6 million [8]. - The reverse split was approved by stockholders on May 9, 2024, and the specific ratio was determined by the Board of Directors [1][8]. - All outstanding options and warrants will be adjusted accordingly, and stockholders will receive cash for any fractional shares based on the closing price on June 14, 2024 [8]. Group 2: Company Background - Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing cancer therapies, including seclidemstat for pediatric cancers and SP-3164 for non-Hodgkin's lymphoma [10]. - The company has received financial support from the National Pediatric Cancer Foundation and a Product Development Award from the Cancer Prevention and Research Institute of Texas [10].

Core Viewpoint - Salarius Pharmaceuticals, Inc. will implement a 1-for-8 reverse stock split to comply with Nasdaq's minimum closing bid price requirement of $1.00, effective June 14, 2024 [1][7]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 4.7 million to about 0.6 million [2]. - All outstanding options and warrants will be adjusted accordingly, and the number of shares reserved for future issuance under the 2015 Equity Incentive Plan and Employee Stock Purchase Plan will also be adjusted [2]. - Stockholders will receive cash for any fractional shares based on the closing price on June 14, 2024, and the par value of common and preferred stock will remain at $0.0001 per share [2][8]. Group 2: Company Overview - Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing cancer therapies, including seclidemstat for pediatric cancers and SP-3164 for non-Hodgkin's lymphoma [9]. - The company has received financial support from the National Pediatric Cancer Foundation and a Product Development Award from the Cancer Prevention and Research Institute of Texas [9].

Financial Performance - The company reported a net loss of $1.7 million for the three months ended March 31, 2024, a decrease of $3.6 million compared to a net loss of $5.3 million for the same period in 2023[94]. - The company has an accumulated deficit of $78.1 million as of March 31, 2024, and has not generated any revenue from product sales since inception[80]. - The company anticipates continued operating losses and requires substantial additional capital within the next several months to sustain operations beyond the first half of 2025[84]. - Net cash used in operating activities was $1.4 million for the three months ended March 31, 2024, a decrease of approximately $1.8 million from the same period in 2023[106]. - The net decrease in cash and cash equivalents was $1.5 million for the three months ended March 31, 2024, compared to a decrease of $2.8 million in the same period last year[105]. Research and Development - Research and development expenses decreased to $243,002 in Q1 2024 from $3.7 million in Q1 2023, reflecting cost-saving measures implemented since Q3 2023[94][95]. - The objective response rate (ORR) for Ewing sarcoma first-relapse patients treated with seclidemstat reached 60%, with a disease control rate (DCR) also at 60%[74]. - The company plans to evaluate data from ongoing clinical trials to inform the development of SP-2577 in hematologic cancers, including acute myeloid leukemia (AML)[92]. - The company has issued 17 patents across six families for its protein degrader technology, with a new patent covering SP-3204 expected to enhance its intellectual property portfolio[75]. Strategic Alternatives and Funding - The company is exploring strategic alternatives, including potential mergers or licensing arrangements, to enhance shareholder value and secure additional funding[99][101]. - The company intends to obtain additional capital through equity securities or debt instruments if necessary, but there is no assurance of success[103]. - If the company does not raise capital or engage a strategic partner in the next several months, it may be forced to cease operations and liquidate assets[104]. - The company may consider new collaborations or selectively partnering its technology to secure additional capital[103]. Cost-Saving Measures - Cost-saving measures include the transition of the CEO to a part-time consultant role and a reduction in cash compensation for non-employee directors starting Q2 2024[77]. - Operating expenses were significantly reduced during the current quarter compared to the same period last year, contributing to the decrease in cash used in operating activities[106]. Accounting and Reporting - There have been no material changes to critical accounting policies from those described in the Annual Report on Form 10-K filed with the SEC[109]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[110].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ———————–––––————————— FORM 10-K ———————————— (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ 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 a ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ 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) (State or oth ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ 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) (State or other ju ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ 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) (State or other j ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ———————–––––————————— FORM 10-K ———————————— (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ 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 a ...

Table of Contents (I.R.S. Employer Identification Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ 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 ...