Market Performance - The Dow traded up 0.64% to 42,206.46 while the NASDAQ dipped 0.79% to 19,010.47 The S&P 500 fell 0.11% to 5,820.34 [1] - Energy shares rose by 1.6% while utilities shares tumbled by 1.8% [1] - European shares closed lower with the eurozone's STOXX 600 declining 0.55%, Germany's DAX 40 falling 0.41%, and France's CAC 40 dipping 0.30% [7] - Asian markets closed lower with China's Shanghai Composite Index falling 0.25%, Hong Kong's Hang Seng Index declining 1%, and India's BSE Sensex falling 1.36% [8] Commodities - Oil traded up 2.7% to $78.66 while gold traded down 1.4% at $2,677.60 Silver traded down 3.1% to $30.345 and copper rose 0.4% to $4.3195 [6] Equities Movement - Phio Pharmaceuticals Corp PHIO shares surged 426% to $6.43 after reporting promising results from its clinical study [10] - Salarius Pharmaceuticals Inc SLRX shares surged 159% to $4.04 following a merger agreement with Decoy Therapeutics [10] - Intra-Cellular Therapies Inc ITCI shares gained 34% to $127.42 after Johnson & Johnson agreed to acquire the company for $132.00 per share [10] - Moderna Inc MRNA shares dropped 20% to $33.67 after updating its 2025 revenue range to $1.5 billion to $2.5 billion, below analyst estimates [10] - Abercrombie & Fitch Co ANF shares fell 18% to $132.09 after issuing mixed guidance [10] - Comtech Telecommunications Corp CMTL shares fell 48% to $2.15 after announcing downbeat quarterly results [10] Economic Indicators - U S consumer inflation expectations for the year ahead remained unchanged at 3% in December [3][9]

Core Viewpoint - Salarius Pharmaceuticals and Decoy Therapeutics are merging to create a new company focused on developing peptide conjugate therapeutics for respiratory viruses and cancer, leveraging Decoy's IMPACT™ platform and non-dilutive funding of approximately $7 million [1][2][10]. Company Overview - Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with a focus on cancer therapies, including seclidemstat and SP-3164 [13]. - Decoy Therapeutics is a preclinical-stage biotechnology company utilizing machine learning and AI to design peptide conjugate drug candidates targeting unmet medical needs in respiratory viruses and GI cancers [12]. Merger Details - The merger will result in Decoy investors owning approximately 86% and Salarius stockholders owning about 14% of the combined company, subject to adjustments [10]. - The newly formed company will be named Decoy Therapeutics and will be led by Decoy's executive team [4][10]. Product Pipeline - Decoy's pipeline includes a pan-coronavirus antiviral and other broad-acting antivirals targeting flu, COVID-19, and respiratory syncytial virus (RSV), as well as peptide drug conjugates for GI cancers [8]. - The merger is expected to facilitate the rapid development of Decoy's peptide conjugate therapeutics, addressing significant unmet needs in respiratory infectious diseases and oncology [2][8]. Leadership and Management - The combined company will be led by Decoy's co-founders and key executives, with a Board of Directors comprising members from both companies [4][10]. - Rick Pierce, with over 25 years of experience in life sciences and investment banking, will serve as CEO [5][6]. Upcoming Milestones - Decoy plans to file an Investigational New Drug (IND) application with the FDA for its lead asset within the next 12 months [8]. - Data from ongoing clinical trials at MD Anderson Cancer Center for seclidemstat will also be reported during this period [9].

Financial Performance - The company reported a net loss of $1.4 million for the three months ended June 30, 2024, a decrease of 63.2% compared to a net loss of $3.9 million for the same period in 2023[78]. - The company has not generated any revenue from product sales and has incurred operating losses since inception[70]. - The company anticipates continuing to incur operating losses for the foreseeable future and is exploring strategic alternatives to enhance shareholder value[88]. - The company has incurred operating losses since inception and expects significant fluctuations in operating losses from quarter to quarter[92]. Research and Development - Research and development expenses decreased to $214,447 for the three months ended June 30, 2024, down from $2.4 million in the same period of 2023, reflecting a reduction of $2.1 million[79]. - Total research and development costs for the six months ended June 30, 2024, were $244,589, a decrease of approximately 89.9% from $2,418,955 in the same period of 2023[86]. - The ongoing Phase 1/2 clinical trial for seclidemstat in Ewing sarcoma was closed to conserve cash while exploring strategic alternatives[66]. - A clinical trial for seclidemstat in combination with azacitidine is on partial clinical hold due to a serious adverse event, with no new patients being enrolled[65]. - The company plans to continue supporting the clinical trial at MDACC while evaluating options for the future development of its drug candidates[66]. Cash Position and Financing - The company had an accumulated deficit of $79.5 million as of June 30, 2024, with cash and cash equivalents of $3.3 million[70]. - As of June 30, 2024, cash and cash equivalents totaled $3.3 million, with working capital at $2.3 million, indicating a decrease primarily due to cash used in operating activities[90]. - Net cash used in operating activities was $2.4 million for the six months ended June 30, 2024, a decrease of approximately $5.2 million from the same period in 2023[97]. - Net cash used by financing activities was $0.2 million for the six months ended June 30, 2024, compared to $7.0 million provided in the same period of 2023[98]. - The company believes its current cash position, along with additional proceeds from stock sales, is sufficient to fund operations into the first half of 2025[90]. - If the company fails to raise capital or engage a strategic partner in the coming months, it may be forced to cease operations and liquidate assets[94]. Strategic Alternatives - The company is exploring strategic alternatives, including potential acquisitions or partnerships, to maximize shareholder value[69]. - The company may consider various strategic transactions, including mergers or collaborations, to fund future operations and modulate liquidity needs[91]. - General and administrative expenses decreased to $1.3 million for the three months ended June 30, 2024, compared to $1.6 million for the same period in 2023[82]. - General and administrative expenses decreased to $2.8 million for the six months ended June 30, 2024, down from $3.3 million in the same period of 2023, reflecting cost-saving measures[87]. - The company sold 564,730 shares of common stock in July 2024, generating gross proceeds of $1.5 million[67].

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 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].

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].

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 ...