On August 8, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported financial results for the three and six months ended June 30, 2022, and provided a business update (Press release, Salarius Pharmaceuticals, AUG 8, 2022, View Source [SID1234618307]). Highlights of the quarter and recent weeks included:
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Financial Highlights
Cash and equivalents were $22.6 million as of June 30, 2022, compared with $29.2 million as of December 31, 2021
Tightly managed expenses while progressing toward multiple near-term milestones
Net loss of $4.7 million, or $0.09 per share, compared with net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021
Seclidemstat (Targeted Protein Inhibitor) Highlights
Added the Seattle Cancer Care Alliance – which is comprised of the Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital and University of Washington Medical Center – and Oregon Health & Sciences University as clinical trial sites, bringing the total number of sites supporting the Phase 1/2 sarcoma clinical trial to 15 with 23 locations across the U.S.
Entered into a development collaboration with Volition Rx to advance rapid epigenetic profiling using Volition’s Nu.Q technology to support further development of seclidemstat
Continued patient enrollment in both the Salarius-sponsored seclidemstat sarcoma clinical trial and the M.D. Anderson Cancer Center investigator-initiated hematologic clinical trial
SP-3164 (Targeted Protein Degrader) Highlights
Advanced plans for filing an Investigational New Drug (IND) application in 1H23 after completing the pre-Investigational New Drug meeting process with the U.S. Food and Drug Administration (FDA)
Introduced SP-3164 to potential strategic partners at BIO International Conference
"The second quarter and recent weeks were extremely productive for Salarius as we advanced both our programs toward multiple near-term milestones. Our Phase 1/2 study with seclidemstat in Ewing’s and other FET-rearranged sarcomas is progressing and the investigator-initiated clinical trial with seclidemstat in hematologic or blood cancers at M.D. Anderson Cancer Center is also progressing. We continue to expect clinical updates from both these programs in the second half of the year," stated David Arthur, CEO of Salarius Pharmaceuticals. "In addition, our development collaboration with Volition Rx should support further development of seclidemstat by studying potential biomarkers to allow for a noninvasive method of determining target engagement and assessing potential drug activity in patients."
Mr. Arthur continued, "And, we were thrilled to add SP-3164 – a type of targeted protein degrader called a molecular glue – to our development pipeline earlier this year. We completed the pre-IND meeting process with the FDA and are proceeding with plans to file an IND in the first half of 2023 and begin clinical studies shortly thereafter. Protein degraders have recently received enormous attention based on their exceptional promise to selectively eliminate cancer-promoting proteins and provide the ability to pursue historically undruggable cancer-promoting targets. We believe protein degradation is an exciting area, in part driven by the commercial success of the first-generation molecular glues, Revlimid and Pomalyst, which together generated more than $16 billion in 2021 global sales. We look forward to providing pre-clinical data updates later this year."
Second Quarter Financial Results
Net loss for the second quarter of 2022 was $4.7 million, or $0.09 per share, compared with a net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021. The increase in net loss was due to higher operating expenses, including development spending on SP-3164, our targeted protein degradation technologies purchased in January 2022. There was no grant revenue in the current quarter.
Net cash used for operating activities during the second quarter of 2022 was $3.6 million, compared with $3.2 million during the same quarter last year.
Six Month Financial Results
Net loss for the first half of 2022 was $10.8 million, or $0.22 per share, compared with a net loss of $4.9 million, or $0.13 per share, for the first half of 2021. The increase in net loss was primarily due to higher research and development expense, primarily resulting from the $2.0 million acquisition and development costs for the SP-3164 technology, seclidemstat development costs, and higher general and administrative expenses, when compared to the prior year. Additionally, there was no grant revenue in the current year, compared with grant revenue of $1.8 million in the first half of 2021.
Net cash used in operating activities for the first half of 2022 was $7.1 million, an increase of $1.2 million from the prior-year period. The increase is primarily due to higher research and development expense.
As of June 30, 2022, Salarius had cash, cash equivalents and restricted cash of $22.6 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 2023.
Conference Call
Salarius will host a conference call and webcast today, beginning at 11:00 a.m. ET to discuss financial results for the second quarter of 2022 and provide a business update.
Participants are encouraged to pre-register for the conference call here to receive a dedicated dial-in number and personal PIN.
Alternatively, participants may access the conference call by dialing:
Following the conclusion of the conference call, a replay will be available until August 15, 2022, and can be accessed by dialing 877-344-7529 (U.S. toll-free), 855-669-9658 (Canada toll-free) or 412-317-0088 (International) with replay access code 2762786. An archive of the webcast will remain available for a period of time.