Avadomide

Patient Enrollment Resumed in the Investigator-initiated Phase 1/2 Clinical Trial of Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Company Implemented Significant Expense-reduction Measures to Extend Cash Runway HOUSTON, March 22, 2024 (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 three and 12 months ended December 31, 2023 and provided a business update. Financial Highlights Net loss for the fourth quarter of 2023 was $0.9 million, or $0.22 per share, compared with a net loss for the fourth quarter of 2022 of $6.4 million, or $2.83 per share, reflecting lower operating expenses resulting from the cost-savings plan implemented in the third quarter of 2023.Net loss for 2023 was $12.5 million, or $3.84 per share, compared with a net loss for 2022 of $31.6 million, or $14.88 per share. The 2022 net loss included a one-time non-cash expense of $8.9 million, or $4.17 per share, due to a loss on impairment of goodwill.Cash and cash equivalents were $5.9 million as of December 31, 2023, compared with $12.1 million as of December 31, 2022. The company collected all its remaining CPRIT payments during 2023. In August 2023 Salarius announced a comprehensive review of strategic alternatives focused on maximizing shareholder value. While these efforts are ongoing, the Company continues to support its clinical programs, as appropriate, and the cost-savings measures approved by the Board of Directors are designed to enable the Company to continue supporting such activities. These measures included a reduction in certain executive, clinical and research and development staff, and the opportunistic engagement of consultants, among other activities. “During the second half of 2023 and the first months of 2024, Salarius reduced operating expenses, allowing us to extend our cash runway to generate additional clinical data in the seclidemstat hematologic and Ewing sarcoma clinical trials. We believe these data, if positive, will further enhance our opportunities to maximize shareholder value,” said William McVicar, Ph.D., Chairman of the Salarius Pharmaceuticals Board of Directors. “As previously announced, the MD Anderson Cancer Center (MDACC) investigator-initiated hematologic cancer trial is active and enrolling patients, and we look forward to clinical trial updates later this year. The Company’s Ewing sarcoma Phase 1/2 study is not currently enrolling patients, but previously enrolled patients continue to be followed.” Fourth Quarter Financial ResultsNet loss for the fourth quarter of 2023 was $0.9 million, or $0.22 per share, compared with a net loss for the fourth quarter of 2022 of $6.4 million, or $2.83 per share. The decrease was due to the cost-savings plan implemented in the third quarter of 2023. Research and development expenses were $0.06 million for the fourth quarter of 2023, compared with $4.7 million for the fourth quarter of 2022, reflecting the above-mentioned cost-savings plan. Net cash used for operating activities during the fourth quarter of 2023 was $1.5 million, compared with $4.7 million during the same quarter in 2022, reflecting the above-mentioned cost-savings plan. Full Year Financial ResultsNet loss for 2023 was $12.5 million, or $3.84 per share, compared with a net loss for 2022 of $31.6 million, or $14.88 per share. This reduction of approximately $19.1 million resulted from an $8.9 million one-time non-cash expense for impairment of goodwill in 2022, significantly lower research and development expenses and lower general and administrative expenses in 2023 resulting from the Company’s idled clinical trial in late 2022, and cost-cutting measures that began in the third quarter of 2023. Costs resulting from the acquisition and development of SP-3164 in 2022 did not repeat in 2023. Research and development expenses were $7.2 million for 2023, compared with $15.8 million for 2022. The decrease was principally due to the company’s lower spending on SP-2577, which went on clinical hold during the fourth quarter of 2022 and remained idle through 2023, cost cutting measures undertaken beginning in the third quarter of 2023 and SP-3164 acquisition costs in 2022 that did not repeat in 2023. Net cash used in operating activities for 2023 was $12.8 million, compared with $17.6 million for 2022. The decrease was primarily due to lower overall operating loss in the current year. As of December 31, 2023, Salarius had cash, cash equivalents and restricted cash of $5.9 million, compared with $12.1 million as of December 31, 2022. Current cash and cash equivalents are expected to fund the company’s planned operations into the first half of 2025. Targeted Protein Inhibitor (Seclidemstat) HighlightsSeclidemstat (SP-2577) is a novel oral reversible inhibitor of the LSD1 enzyme that is being studied as a treatment for hematologic cancers in an investigator-initiated clinical trial at MDACC and in a Company-sponsored trial as a treatment for Ewing sarcoma. In December 2022, researchers at MDACC reported interim clinical trial results evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome and chronic myelomonocytic leukemia patients who relapsed or progressed after hypomethylating agent therapy. Of eight evaluable patients, four (50%) had an objective response. These researchers reported a 90% probability of survival for 11 months in patients receiving seclidemstat plus azacitidine. Typically, overall survival is four to six months after failing therapy with hypomethylating agents. The hematologic cancer Phase 1/2 clinical trial being conducted at MDACC is now listed as active and recruiting on clinical trials.gov – trial NCT04734990. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) for Ewing sarcoma and has been studied in a Company-sponsored Phase 1/2 trial evaluating its use in combination with topotecan and cyclophosphamide (TC) for the treatment of relapsed/refractory Ewing sarcoma. To date, 13 relapsed Ewing sarcoma patients, including five patients with first relapse and eight patients with second relapse, have been enrolled at 600 mg or 900 mg of seclidemstat dosed twice daily in combination with TC. The five first-relapse patients demonstrated a 60% objective response rate (ORR) and a 60% disease control rate (DCR), including one complete response and two partial responses. Among the three patients achieving objective responses, the median progression-free survival (mPFS) has not been reached with these patients still alive with disease control and objective responses at 17.4, 25.7 and 27.2 months, and increasing, after starting seclidemstat + TC combination therapy.The eight second-relapse patients demonstrated a 13% ORR, a 25% DCR and a mPFS of 1.6 months (range: 0.0 months to 10.7 months).Together, the 13 first- and second-relapse patients demonstrated a mPFS of 8.1 months (range: 2.0 months to 27.2 months). Five patients, or 38%, achieved confirmed disease control and progression has not been observed in any of these patients while on study. Salarius has completed the FDA Type B End of Phase 2 (EOP2) meeting process for the seclidemstat Ewing sarcoma development program and has amended the current clinical trial protocol to reflect guidance agreed to with FDA. There is currently one patient enrolled in the Ewing sarcoma clinical trial who recently achieved a partial response, defined as a 30% or greater reduction in their target lesions, and this patient is continuing treatment with seclidemstat plus TC therapy. The Ewing sarcoma trial is currently active but is not enrolling additional patients. Targeted Protein Degrader (Molecular Glue) HighlightsSP-3164 is an oral, next-generation molecular glue that uses Salarius’ deuterium-enabled chiral switching platform to stabilize the preferred (S)-enantiomer of avadomide, an extensively studied clinical compound that has demonstrated encouraging single-agent and combination-therapy clinical efficacy in non-Hodgkin lymphoma (NHL) and other hematologic malignancies. The addition of deuterium at the chiral center of the molecule prevents conversion to the unwanted (R)-enantiomer, allowing for isolation and development of the preferred (S)-enantiomer into a potential new cancer treatment. In July 2023 the FDA cleared the Company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory NHL. That trial has not commenced. About Salarius PharmaceuticalsSalarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, its lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader being developed for the treatment of non-Hodgkin’s lymphoma. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ ability to continue as a going concern, Salarius’ expectations regarding the exploration of strategic alternatives, opportunities to extend Salarius’ resources, the Company’s expected cash runway, the Company’s expectations that the cost-savings measures will support the generation of additional data from the ongoing Phase 1/2 clinical trials in hematologic cancers and Ewing sarcoma; the future of the Company’s operations and product candidates; the future of the Company’s preclinical studies and clinical trials and development activities; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the value of seclidemstat as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients, and Salarius’ ability to remain listed on Nasdaq. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in these forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; the likelihood that the Company will need to seek a dissolution and orderly wind-down of operations if the Company is unable to raise capital or complete a strategic transaction in the next several months; expectations regarding future costs and expenses; our product candidates being in early stages of development; the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with limited financial, personnel and other operating resources (including with respect to the allocation of our limited capital and the sufficiency of our capital in the near term for any path we do select); Salarius’ ability to continue as a going concern; the sufficiency of Salarius’ capital resources; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce; the risk of not having a full-time chief executive officer; future clinical trial results and the impact of such results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the competitive landscape and other industry-related risks; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. 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. Contact: LHA Investor RelationsKim Sutton Golodetzkgolodetz@lhai.com212-838-3777 SALARIUS PHARMACEUTICALS, INC.CONSOLIDATED BALANCE SHEETS December 31, 2023 2022 Assets Current assets: Cash and cash equivalents$5,899,910 $12,106,435 Grants receivable from CPRIT — 1,610,490 Prepaid expenses and other current assets 619,763 803,373 Total current assets 6,519,673 14,520,298 Other assets 66,850 130,501 Total assets$6,586,523 $14,650,799 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable$602,853 $2,858,330 Accrued expenses and other current liabilities 406,745 1,407,861 Notes payable 289,643 $— Total liabilities$1,299,241 $4,266,191 Commitments and contingencies (NOTE 5) 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; 3,938,433 and 2,255,899 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 393 225 Additional paid-in capital 81,634,730 74,189,531 Accumulated deficit (76,347,841) (63,805,148)Total stockholders' equity 5,287,282 10,384,608 Total liabilities and stockholders' equity$6,586,523 $14,650,799 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Twelve Months EndedDecember 31 2023 2022 Operating expenses: Research and development 7,173,747 15,836,828 General and administrative 5,721,197 7,138,403 Loss on impairment of goodwill — 8,865,909 Total operating expenses 12,894,944 31,841,140 Loss before other income (expense) (12,894,944) (31,841,140)Change in fair value of warrant liability — 14,454 Interest income 352,251 218,730 Net loss$(12,542,693) $(31,607,956) Loss attributable to common stockholders$(12,542,693) $(31,607,956) Loss per common share — basic and diluted$(3.84) $(14.88)Total net loss per share$(3.84) $(14.88)Weighted-average number of common shares outstanding — basic and diluted 3,264,620 2,124,511