Salinicola salarius

Salarius Completes FDA Type B Meeting for Seclidemstat Ewing Sarcoma Development Program

Retrieved on: 
Tuesday, November 7, 2023
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HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.

Key Points: 
  • FDA briefing included new Ewing sarcoma clinical data from ongoing investigation where 60% of first-relapse patients achieved disease control and have not progressed after at least 14.5, 19.7 and 22.8 months
    Future development activities were identified; Salarius intends to submit an amended Ewing sarcoma clinical trial protocol
    HOUSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma.
  • The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting.
  • Salarius is currently evaluating strategic options to advance the clinical development of seclidemstat with a third party.
  • The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma.

Salarius Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides a Business Update

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Thursday, August 10, 2023
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HOUSTON, Aug. 10, 2023 (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 six months ended June 30, 2023 and provided a business update.

Key Points: 
  • Research and development expenses declined to $2.4 million for the second quarter of 2023 from $2.9 million for the second quarter of 2022, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164.
  • Spending associated with seclidemstat and SP-3164 for the second quarter of 2023 was $1.1 million and $1.3 million, respectively, compared with $2.1 million and $0.8 million, respectively, for the second quarter of 2022.
  • General and administrative expenses were $1.6 million for the second quarter of 2023, compared with $1.8 million for the second quarter of 2022, with the decline due to lower annual shareholder meeting expenses and overall compensation and benefit costs.
  • As of June 30, 2023, Salarius had cash, cash equivalents and restricted cash of $11.5 million, compared with $12.1 million as of December 31, 2022.

Salarius Pharmaceuticals Announces Plans to Explore Strategic Alternatives and Implement Measures to Extend its Resources

Retrieved on: 
Tuesday, August 8, 2023
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HOUSTON, Aug. 08, 2023 (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 announced plans to explore strategic alternatives and implement measures to extend its resources.

Key Points: 
  • HOUSTON, Aug. 08, 2023 (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 announced plans to explore strategic alternatives and implement measures to extend its resources.
  • The Company has retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the Company.
  • If the Company is unable to complete a transaction, it may be necessary to seek other alternatives for restructuring and resolving its liabilities, including an orderly wind-down of operations.
  • Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded that disclosure is appropriate or legally required.

Salarius Pharmaceuticals Receives FDA Clearance of SP-3164 Investigational New Drug Application to Begin a Phase 1 Clinical Trial in Relapsed/Refractory Non-Hodgkin Lymphoma Patients

Retrieved on: 
Tuesday, July 11, 2023
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HOUSTON, July 11, 2023 (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, announces U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics.

Key Points: 
  • Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics.
  • RareDiseaseAdvisor estimates that DLBCL is the most common type of NHL, accounting for approximately 31% of NHL cases in Western countries2.
  • During the trial, Salarius will be assessing the applicability of the gene signature in predicting response to SP-3164.
  • Previous research with similar agents indicates that patients with an identifiable gene signature may be more likely to respond to SP-3164 treatment.

Salarius Pharmaceuticals Presents SP-3164 Targeted Protein Degrader Preclinical Data at the European Hematology Association 2023 Hybrid Congress

Retrieved on: 
Monday, June 12, 2023
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SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.

Key Points: 
  • SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.
  • In addition to having direct antitumor effects, SP-3164 also induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment.
  • We plan to begin a Phase 1 study in the second half of the year,” said David Arthur, president and chief executive officer of Salarius.
  • “Our first therapeutic target is blood cancer, and we are excited to embark on a potential new treatment option for these patients.”

Salarius Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, May 11, 2023
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HOUSTON, May 11, 2023 (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 months ended March 31, 2023 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $9.3 million as of March 31, 2023, compared with $12.1 million as of December 31, 2022.
  • The decline reflects lower spending on seclidemstat in the 2023 quarter and one-time expenses of $2.0 million related to the purchase of the targeted protein degrader program in the 2022 quarter.
  • “In addition, Salarius continued to execute on plan during the first quarter of 2023 and recent weeks as we advanced the development of SP-3164, our targeted protein degrader.
  • Salarius will be participating in the 2023 BIO International Convention in Boston June 5-8, and the European Hematology Association 2023 Congress in Frankfurt, Germany June 8-11.

FDA Removes Partial Clinical Hold on Salarius Pharmaceuticals’ Phase 1/2 Clinical Trial with Seclidemstat in Patients with Ewing Sarcoma

Retrieved on: 
Tuesday, May 9, 2023
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HOUSTON, May 09, 2023 (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, announces that the U.S. Food and Drug Administration (FDA) has removed its partial clinical hold on Salarius’ Phase 1/2 Ewing sarcoma clinical trial evaluating seclidemstat, Salarius’ novel oral, reversible, targeted LSD1 inhibitor.

Key Points: 
  • The FDA previously granted seclidemstat Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma.
  • “We are confident in seclidemstat’s ability to improve the lives of patients with Ewing sarcoma and are delighted the FDA has removed the partial clinical hold,” said David Arthur, president and chief executive officer of Salarius.
  • Ewing sarcoma is a devasting bone and soft tissue cancer with limited treatment options that afflicts children, adolescents and young adults.
  • The maximum tolerated dose, which will inform the Phase 2 portion of the trial, had not yet been reached.

Salarius Pharmaceuticals Reports No Adverse Safety Signals from Two Good Laboratory Practice Toxicology Studies with its Targeted Protein Degrader SP-3164

Retrieved on: 
Monday, May 1, 2023
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HOUSTON, May 01, 2023 (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, announces the completion of two Good Laboratory Practice (GLP) toxicology studies with its targeted protein degrader SP-3164, with no unexpected safety findings during the course of either study.

Key Points: 
  • HOUSTON, May 01, 2023 (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, announces the completion of two Good Laboratory Practice (GLP) toxicology studies with its targeted protein degrader SP-3164, with no unexpected safety findings during the course of either study.
  • These GLP toxicology reports will be included in the Investigational New Drug (IND) application the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2023.
  • “We are encouraged by the successful completion of these GLP toxicology studies, which represents another significant milestone in the development of SP-3164.
  • Based on preclinical research completed to date, we believe SP-3164 has potential to address several types of lymphomas and other cancers both as monotherapy and in combination with approved standard of care therapies,” said David Arthur, president and chief executive officer of Salarius.

Salarius Pharmaceuticals Presents Compelling Data in Two SP-3164 Targeted Protein Degrader Posters at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Thursday, April 20, 2023
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HOUSTON, April 20, 2023 (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 announced the presentation of two posters related to the company’s novel molecular glue, SP-3164, at the American Association for Cancer Research (AACR) Annual Meeting. Both abstracts highlight preclinical findings with SP-3164, with one focused on non-Hodgkin lymphoma (NHL) and the other on multiple myeloma (MM).

Key Points: 
  • Both abstracts highlight preclinical findings with SP-3164, with one focused on non-Hodgkin lymphoma (NHL) and the other on multiple myeloma (MM).
  • “These two studies presented at the prestigious AACR Annual Meeting are adding to the growing body of SP-3164 preclinical data demonstrating anticancer activity alone and in combination with standard-of-care treatments,” said David Arthur, president and chief executive officer of Salarius.
  • In addition, the data showed SP-3164 induced apoptosis in multiple myeloma cell lines.
  • In animal models, SP-3164 demonstrated superior single-agent activity compared to both lenalidomide (Revlimid®) and pomalidomide (Pomalyst®).

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 27, 2023
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HOUSTON, March 27, 2023 (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, 2022 and provided a business update.

Key Points: 
  • Cash and cash equivalents were $12.1 million as of December 31, 2022, compared with $29.2 million as of December 31, 2021.
  • Research and development expenses were $4.7 million in the fourth quarter of 2022, compared with $2.7 million in the fourth quarter of 2021.
  • As of December 31, 2022, Salarius had cash, cash equivalents and restricted cash of $12.1 million, compared with $29.2 million as of December 31, 2021.
  • Current cash and cash equivalents are expected to fund the company’s planned operations into the fourth quarter of 2023.