On May 14, 2024 Icosagen, a CRDMO with expertise in innovative antibody research and production, reported a strategic partnership on selected projects with Lead Discovery Center GmbH (LDC), a translational drug discovery organization tapping on a broad network in academia and industry (Press release, Icosagen Cell Factory, MAY 14, 2024, View Source [SID1234643223]). This alliance is focused on the discovery of monoclonal antibody portfolios targeting therapeutically relevant proteins, including a pivotal G-protein coupled receptor (GPCR), which are often challenging to address.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Scope of Collaboration
Antibody-based inhibitors have gained relevance in the field of drug discovery due to their exceptional affinity, selectivity and physicochemical properties. Within this collaboration, Icosagen will generate, identify, and discover potent antibodies against innovative and therapeutically relevant targets, supplying them to LDC for further development.

Utilizing its proprietary technology, Icosagen will produce the proteins of interest and enhance their display on the surface of virus-like particles, which serve as vehicles for the production of antibodies with affinity for the targets. Subsequently, an extensive library will be established to facilitate the selection of high-affinity monoclonal antibodies, which will undergo further analysis at LDC through a streamlined process of high-throughput screening. This partnership highlights Icosagen’s capability to scale its proprietary platforms and synergize effectively with LDC’s workflow.

"Partnering with LDC will further help expand the opportunities for antibody therapeutics, especially in the challenging field of GPCR-targeted treatments" said professor Mart Ustav, CEO of Icosagen. "This will not only highlight our technological expertise but also perfectly aligns with our mission to transform scientific discoveries into life-changing treatments."

"We are excited to partner up with Icosagen, a competent and highly experienced player in the field of antibody research" remarked Bert Klebl, CEO and CSO of LDC. "This project will greatly benefit from Icosagen´s expertise and state-of-the-art capabilities as we pursue our shared goal: the development of novel therapeutics that can make a meaningful difference in healthcare."

Future Prospects
LDC takes on promising early-stage projects from academia and transforms them into innovative pharmaceutical leads and antibodies that reach initial proof-of-concept in animals as well as candidate nomination. In close collaboration with high-profile partners from research and industry, LDC is building a strong and growing portfolio of small molecule and antibody leads with exceptional medical and commercial potential.

The partnership between Icosagen and LDC holds promise in advancing targeted therapeutics, with the potential to revolutionize treatment approaches and improve outcomes for patients worldwide. The successful development of these monoclonal antibodies is anticipated to significantly advance the understanding and treatment of diseases.

On May 14, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the first patient has been enrolled and dosed in the Company’s Phase 1 dose escalation portion of the Acclaim-3 clinical study of Reqorsa (quaratusugene ozeplasmid) Immunogene Therapy in combination with Genentech’s Tecentriq to treat patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Genprex, MAY 14, 2024, View Source [SID1234643222]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to take this next step in our fight against lung cancers as we work to advance an innovative therapy that we believe provides hope to patients suffering with ES-SCLC, an especially aggressive form of lung cancer that has extremely limited treatment options," said Ryan Confer, President and Chief Executive Officer at Genprex. "With a median progression free survival (PFS) of 5.2 months, ES-SCLC has a particularly poor prognosis. Additionally, patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. With such limited benefit from current treatments, we believe the combination of REQORSA and Tecentriq can provide a promising new therapeutic option for the treatment of small cell lung cancer."

"The Phase 1 dose escalation portion of the Acclaim-3 study is expected to determine the maximum tolerated dose for the Phase 2 expansion study," stated Mark Berger, M.D., Chief Medical Officer of Genprex. "The favorable results from our Phase 1 Acclaim-1 study in non-small cell lung cancer (NSCLC) enabled us to shorten the Phase 1 portion of Acclaim-3. This should allow us to complete the Phase 1 portion of the study during the second half of 2024 and to advance more quickly into the Phase 2 expansion portion of Acclaim-3 in the second half of 2024. We look forward to providing study updates as we advance this potentially life-saving therapy to benefit patients battling ES-SCLC."

Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein may lead to improved clinical efficacy in combination with Tecentriq.

About the Acclaim-3 Clinical Trial

The Acclaim-3 clinical trial is a Phase 1/2 open-label, dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq in patients with ES-SCLC. The Acclaim-3 clinical trial will enroll patients who did not develop tumor progression after receiving Tecentriq and chemotherapy as standard initial treatment, and who are therefore eligible for maintenance therapy.

The Phase 1 dose escalation portion of the Acclaim-3 clinical study is expected to enroll up to 12 patients at approximately ten U.S. clinical sites to determine the Maximum Tolerated Dose (MTD). If no dose limiting toxicities occur during the Phase 1 study, the highest dose evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion of the study is expected to enroll approximately 50 patients at ten to fifteen U.S. sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex expects to initiate the Phase 2 expansion study in the second half of 2024.

The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq treatment in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.

Genprex has received U.S. Food and Drug Administration (FDA) Ophran Drug and Fast Track designations for Reqorsa Immunogene Therapy, in combination with Genentech, Inc’s Tecentriq in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Additional information about the Acclaim-3 clinical trial can be found by visiting ClinicalTrials.gov.

About Reqorsa Immunogene Therapy
Reqorsa (quaratusugene ozeplasmid) Immunogene Therapy for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid-based molecules in a lipoplex form (Genprex’s Oncoprex Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. In addition, REQORSA disrupts the metabolism of cancer cells by decreasing glycolysis and ATP production in cancer cells with decreased TUSC2.

Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Tecentriq is a registered trademark of Genentech, Inc.

On May 14, 2024 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held in Madrid, Spain and virtually, June 13-16, 2024 (Press release, Genmab, MAY 14, 2024, View Source [SID1234643221]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentations will include data from clinical trials evaluating the safety and efficacy of epcoritamab as a monotherapy and in combination with standard-of-care or other novel therapies across multiple patient populations. Three oral presentations will highlight data from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory follicular lymphoma (FL), from EPCORE NHL-5 evaluating epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as a potential first-line treatment regimen for patients with diffuse large B-cell lymphoma (and DLBCL), and from EPCORE CLL-1 evaluating epcoritamab in patients with Richter’s transformation (RT). All abstracts accepted for presentation have been published and may be accessed online via the EHA (Free EHA Whitepaper) Open Access Library.

"Building on the recent global regulatory approvals and pending regulatory decisions for epcoritamab, we look forward to presenting new data at EHA (Free EHA Whitepaper) 2024 that highlight the key progress that has been made developing epcoritamab as a potential core therapy across a variety of B-cell malignances," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we are committed to advancing and evolving the robust development program evaluating epcoritamab, as a monotherapy and in combination, across B-cell malignancies and settings."

The safety and efficacy of these investigational uses have not been established.

Abstracts accepted for presentation at EHA (Free EHA Whitepaper):

Clinical Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S163 Single-Agent Epcoritamab Leads to Deep Responses in Patients (pts) with Richter’s Transformation (RT): Primary Results from the EPCORE CLL-1 Trial Oral Friday, June 14, 14:45-16:00 CEST
S239 First Data from Subcutaneous Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for First-line Diffuse Large B-Cell Lymphoma (DLBCL): EPCORE NHL-5 Oral Friday, June 14, 14:45-16:00 CEST
S234 Epcoritamab Induces Deep Responses in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Safety and Pooled Efficacy Data from EPCORE NHL 1 Pivotal and Cycle (C) 1 Optimization (Opt) FL Cohorts Oral Saturday, June 15, 16:30-17:45 CEST
P1146 Epcoritamab with Rituximab + Lenalidomide (R2) in Previously Untreated (1L) Follicular Lymphoma (FL) and Epcoritamab Maintenance Therapy in FL: EPCORE NHL 2 Arms 6 and 7 Poster Friday, June 14, 18:00-19:00 CEST
P1151 Extended Follow-Up Beyond 2.5 Years Shows Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P1152 Epcoritamab + GemOx Induces Deep, Durable Responses in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma: Updated Results From the EPCORE NHL-2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P1161 Epcoritamab + R-DHAX/C Elicits Deep, Durable Responses in Transplant-Eligible Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Including High-Risk Disease Poster Friday, June 14, 18:00-19:00 CEST
PB2955 EPCORE FL-2: Phase 3 Trial of Epcoritamab with Rituximab and Lenalidomide (R2) vs Chemoimmunotherapy or R2 in Previously Untreated Follicular Lymphoma Electronic Publication Friday, June 14, 9:00 CEST
Outcomes Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1114 Patient-Reported Outcomes in Patients with Relapsed or Refractory Follicular Lymphoma Treated With Epcoritamab Poster Friday, June 14, 18:00-19:00 CEST
P1121 Matching-Adjusted Indirect Comparisons of Epcoritamab vs Mosunetuzumab or Odronextamab in Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies Poster Friday, June 14, 18:00-19:00 CEST
P1140 The Efficacy of Subcutaneous Epcoritamab vs Standard-of-Care (SCHOLAR-5) in Patients With Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies: An Indirect Treatment Comparison Poster Friday, June 14, 18:00-19:00 CEST
P1133 Comparative Effectiveness of Epcoritamab versus Real-World Usual Care in Relapsed/Refractory Follicular Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P2081 Logistical Challenges Associated with Chimeric Antigen Receptor T-Cell Therapy (CAR T) in Non-Hodgkin Lymphoma (NHL): A Survey of Healthcare Professionals Electronic Poster Friday, June 14, 9:00 CEST
Pharmacokinetic/Translational Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1244 Immune Correlates of Response to Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Dose Expansion in a Phase 1/2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P2059 Minimal Residual Disease (MRD), Pharmacokinetic (PK), and Pharmacodynamic (PD) Assessment of Epcoritamab 2-vs 3-step Step-up Dosing in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) Electronic Poster Friday, June 14, 9:00 CEST
P2060 Model-Based Cycle (C) 1 Optimization of Step-Up Dose Regimen For Epcoritamab in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Electronic Poster Friday, June 14, 9:00 CEST
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

On May 14, 2024 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of March 31, 2024 and revenues for the first three months of 2024 (Press release, Genfit, MAY 14, 2024, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2024-financial-information [SID1234643220]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cash position

As of March 31, 2024, the Company’s cash and cash equivalents amounted to €74.0 million compared with €128.6 million as of March 31, 2023, and €77.8 million as of December 31, 2023.

The stability in cash and cash equivalents between December 31, 2023, and March 31, 2024 takes into account changes in accounts receivables (notably the receipt of the €13.3 million milestone invoiced to Ipsen in December 2023) offset by our continued research and development efforts, notably for:

UNVEIL-IT, our Phase 2 clinical trial evaluating VS-01 in Acute-on-Chronic Liver Failure (ACLF);
our cholangiocarcinoma program evaluating GNS561;
our ACLF program evaluating NTZ; and
our non-clinical trial of SRT-015 in ACLF.
We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2025. This is based on current assumptions and programs and does not include exceptional events. This estimation includes our expectations to receive future milestone revenue in 2024, subject to approval by applicable regulatory authorities and US and European commercial launches of elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen, representing a total of approximately €75.2 million.

Revenues

Revenues for the first three months of 2024 amounted to €1.1 million compared to €5.0 million for the same period in 2023.

This revenue for the first three months of 2024 was generated under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE clinical trial until the complete transfer of the responsibility of the trial to Ipsen.

Of the €5.0 million in revenues for the first three months of 2023, €4.1 million in revenue was attributable to the partial recognition of the €40.0 million deferred income per IFRS 15 in accordance with the Collaboration and Licensing Agreement signed with Ipsen in 2021. €0.8 million was attributable to re-billings made in accordance with this agreement. €0.1 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022.

On May 14, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Sellas Life Sciences, MAY 14, 2024, View Source [SID1234643219]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"SELLAS had a very productive and successful first quarter of 2024," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We reported strong preliminary data from the Phase 2a study of SLS009 in r/r AML showing high anti-leukemic activity in the selected optimal dose regimen of 30 mg BIW, including a 100% response rate in patients with ASXL1 mutation. Based on these results we are expanding the cohort to participants bearing the ASXL1 mutation. This mutation is prevalent in AML, as well as solid tumors including colon cancer, and is associated with poor prognosis. We strongly believe in SLS009’s potential and hope to deliver its promise to this heavily pretreated, underserved patient population. The data thus far are indeed extremely encouraging both in terms of safety and efficacy."

Dr. Stergiou continued: "We are also excited with the ongoing progress in the Phase 3 REGAL study of GPS. Based on its recent efficacy and safety assessment, the IDMC recommended the trial continue without modification. We look forward to the next IDMC meeting, scheduled for June, during which the Committee will review data from all enrolled 127 patients and the most recent information regarding the number of events required for triggering the interim analysis. Furthermore, with the recent financing, we were able to strengthen our balance sheet as we expect further significant catalysts throughout 2024."

Pipeline Highlights

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: Reached planned enrollment of patients in the United States, Europe, and Asia, following the predetermined statistical analysis plan. The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC scheduled its next meeting in June 2024 to review the safety and efficacy data from all enrolled 127 patients.

SLS009: highly selective and specific CDK9 inhibitor

Announced Positive Phase 2 Data of SLS009 in r/r AML: The preliminary data showed 62% and 67% anti-leukemic activity at all dose levels and in the 30 mg BIW cohort, respectively, with a favorable safety profile. A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutation in the 30 mg BIW cohort to date. Enrollment is ongoing at the 30 mg BIW cohort with ASXL1 mutation.
IP Protection: Based on the SLS009 efficacy data in r/r AML patients with ASXL1 mutation, SELLAS filed a provisional patent application. The ASLX1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.

Phase 1b/2 clinical trial in combination with BTK inhibitor, Brukinsa (zanubrutinib), in r/r DLBCL: GenFleet Therapeutics (Shanghai), Inc. entered into a clinical trial collaboration and supply agreement with BeiGene Switzerland GmbH and dosed the first patient in March 2024. The trial is an open-label single-arm multicenter Phase 1b/2 study to be conducted in two parts. In the Phase 1b portion, 6-18 patients will be enrolled and in the Phase 2 portion, approximately 45 patients will be enrolled. This study is being conducted in China and is funded by GenFleet which intends to focus on DLBCL as its lymphoma target with SLS009.

National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
Financial Results for the First Quarter 2024:
R&D Expenses: Research and development expenses for the quarter ended March 31, 2024 were $5.1 million, compared to $7.2 million for the same period in 2023. The decrease was primarily due to the timing of a clinical drug supply purchase in the prior period and decreases in consultants, personnel related expenses due to changes in headcount, and licensing fees.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $4.5 million, as compared to $4.1 million for the same period in 2023. The slight increase was primarily attributed to the initial recognition of a one-time severance charge in the first quarter of 2024, partially offset by decreases in outside services and public company costs and other personnel related expenses.
Net Loss: The net loss was $9.6 million for the first quarter of 2024, or a basic and diluted loss per share of $0.21, as compared to a net loss of $11.1 million for the first quarter of 2023, or a basic and diluted loss per share of $0.47.
Cash Position: As of March 31, 2024, cash and cash equivalents totaled approximately $18.4 million.