Core Insights - Marker Therapeutics, Inc. has made significant advancements in its lead therapy MT-601, showing a 78% objective response rate in patients with refractory lymphomas, including durable complete responses [1][2] - The company secured over $13 million in non-dilutive funding from CPRIT and NIH to support its clinical programs for pancreatic and lymphoma treatments [1][2] - The USAN and INN committees approved "neldaleucel" as the nonproprietary name for MT-601, indicating progress in regulatory recognition [1][12] Program Updates - MT-601 is currently being evaluated in the Phase 1 APOLLO study for patients with anti-CD19 CAR-T relapsed lymphoma, with no reported dose-limiting toxicities and a favorable safety profile [5][12] - The APOLLO study reported that 7 out of 9 patients achieved objective responses, with 4 patients demonstrating complete responses [5] - The company plans to launch a clinical program for MT-601 in metastatic pancreatic cancer in the second half of 2025, supported by $2 million from NIH and $9.5 million from CPRIT [5][12] Financial Highlights - As of December 31, 2024, Marker Therapeutics had cash and cash equivalents of $19.2 million, which is expected to fund operations into Q1 2026 [7] - Research and development expenses increased to $13.5 million in 2024 from $10.4 million in 2023, while general and administrative expenses decreased to $4.2 million from $7.5 million [8] - The company reported a net loss of $10.7 million for the year ended December 31, 2024, compared to a net loss of $8.2 million in 2023 [8][17] Corporate Highlights - The company completed a $16.1 million private placement to support the clinical advancements of the Phase 1 APOLLO study, involving participation from notable investors [12] - Marker Therapeutics is focused on cash preservation and disciplined execution to maximize the impact of its clinical programs as it moves into 2025 [2][12] - The company aims to introduce novel T cell therapies to the market, prioritizing operational excellence and financial resource preservation [10]

Product Development - The company is advancing two product candidates for three clinical indications as part of its MAR-T cell program, including MT-601 for lymphoma and pancreatic cancer, and MT-401-OTS for various indications[20]. - The ongoing Phase 1/2 TACTOPS trial for MT-601 in pancreatic cancer showed a clinical benefit with 31% of patients (4 out of 13) demonstrating objective responses[29]. - The MT-401-OTS program aims to provide treatment to patients in as little as 72 hours, with the first patient expected to be dosed in the second half of 2025[35]. - The company aims to lead in the development and commercialization of transformative immunotherapies for hematological malignancies and solid tumors, significantly improving patient survival and quality of life[40]. - The company plans to prioritize the advancement of MT-601 in patients with lymphoma and advance the MT-401-OTS program in patients with AML and MDS based on positive Phase 1 clinical trial results[41]. - The company intends to initiate additional clinical trials in other tumor types based on emerging data from ongoing studies[42]. - The company has observed no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity in its trials to date, indicating a favorable safety profile for its therapies[36]. - The company has experienced setbacks in clinical trials due to safety and efficacy concerns, which could lead to increased costs or abandonment of product candidates[210]. Clinical Trial Results - In the Phase 1 APOLLO study for MT-601, 78% of patients (7 out of 9) achieved objective responses at the first assessment, with a complete response rate of 44.4%[25]. - In a Phase 1 clinical trial for lymphoma, complete responses were observed in 6 out of 15 evaluable patients, with no relapses reported among those who achieved complete responses[60]. - The company reported an estimated two-year overall survival rate of 77% for patients treated with MAR-T cell therapy in a Phase 1 AML/MDS trial, compared to a two-year survival probability of 42% for risk-matched patients post-HSCT[67]. - In a Phase 1 clinical trial for lymphoma, 32 patients received MAR-T cell therapy, with 4 achieving objective responses and 1 achieving a complete response at month nine[74]. - Among 13 evaluable patients in the active lymphoma group, 6 experienced stable disease, and 9 exceeded historical overall survival rates[76]. - In the adjuvant lymphoma group, all 17 patients entered complete remission, with 14 maintaining remission without relapse, and response duration ranged from approximately 9 months to over 5 years[78]. Manufacturing and Production - The new T cell manufacturing process for MT-401 reduces production time to 9 days, allowing a 90% decrease in the number of interventions during production[36]. - The manufacturing process for MAR-T cell therapies has been optimized, reducing total manufacturing time from 36 days to 9 days, resulting in a four-fold increase in potency in vitro[43]. - The manufacturing process for MAR-T cell therapies involves isolating PBMCs and expanding T cells, resulting in an average of approximately 4,000 different T cell clonotypes per patient product[85]. - The standard dose for lymphoma patients ranges from 100 to 400 million cells per adult patient[86]. - The company has opened an in-house cGMP manufacturing facility in Houston, Texas, but has since sold its manufacturing assets to Cell Ready, LLC, and now relies on third-party vendors for clinical and commercial manufacturing[219]. - The company plans to evaluate and qualify additional third-party manufacturing partners in anticipation of a larger pivotal trial for lymphoma in 2026[90]. - The company has entered into a Master Services Agreement with Cell Ready for product supply, but this agreement was mutually terminated in March 2025[221]. - The manufacturing process is dependent on specialized equipment and materials, which may not be available on acceptable terms, impacting production capabilities[226]. Financials and Funding - The company incurred $5.8 million and $1.3 million in expenses related to services and manufacturing costs for the years ended December 31, 2024 and 2023, respectively[92]. - The company has a history of operating losses and expects these losses to continue indefinitely, raising substantial doubt about its ability to continue as a going concern[181]. - The company anticipates that its operational costs will increase significantly, leading to a growing deficit as it continues its clinical development program[181]. - The company plans to raise additional capital through the issuance of common shares and grant funds to fund operations beyond the first quarter of 2026[184]. - The company has sustained losses from operations in each fiscal year since inception, with expectations of continued losses due to substantial investments in research and development[183]. - The company currently carries product and clinical trial liability insurance, but there is no assurance that claims will not exceed coverage limits[171]. Regulatory and Compliance - The FDA granted orphan drug designation to MT-601 for pancreatic cancer treatment in January 2022, and the company received a $9.5 million grant from CPRIT and a $2 million grant from NIH to support clinical investigations[30]. - The FDA's review process for biologic product candidates typically involves a ten-month review for standard applications and six months for priority reviews after submission of a Biologics License Application (BLA)[139]. - The company must complete preclinical and clinical trials, including three phases of human clinical trials, before submitting a BLA for FDA approval[135]. - The FDA may require additional Phase 4 studies after product approval to monitor safety and efficacy, which could limit further marketing based on study results[141]. - The FDA offers expedited development programs, such as fast-track and breakthrough therapy designations, to facilitate the review process for products addressing serious conditions[142][143]. - The company must navigate various regulatory requirements for research, development, and marketing of its product candidates in multiple jurisdictions[132]. - The FDA closely regulates marketing and promotion of biologics, limiting claims to those approved in the product's labeling[154]. - Compliance with FDA regulations is mandatory post-approval, including record-keeping and reporting of adverse experiences[152]. Intellectual Property - The company’s intellectual property strategy focuses on obtaining and maintaining patent protection for its technologies, which is vital for its commercial success[120]. - The company’s patent portfolio includes claims directed to methods of generating multi-antigen specific T cell products and their therapeutic uses[117]. - The company is responsible for reimbursing BCM for patent-related expenses and maintaining all patent applications included in the licensed rights[102]. - The company has pending patent applications covering various medical technologies, but the outcome of these applications is uncertain, and they may face significant costs in opposition proceedings[126]. - The company relies on trade secrets and regulatory protections, such as orphan drug designations and data exclusivity, to maintain its proprietary position in immuno-oncology[128]. - The company retains ownership over any intellectual property developed under the CPRIT grant agreements, with a nonexclusive license granted to CPRIT for non-commercial use[112]. Market Competition - The company faces competition from multiple pharmaceutical and biotechnology companies, with a significant unmet medical need for effective treatments for relapsed lymphoma patients[95]. - The company’s MAR-T cell drug candidates may compete with various immunotherapies, including non-CD19 targeting CAR-T cells and bispecific antibodies[96]. - The company may face difficulties in patient enrollment for future clinical trials due to competition with other trials in the same therapeutic areas, which could delay trial completion and commercialization[209]. Operational Risks - The company is dependent on third-party vendors for manufacturing and cell processing, and disruptions could adversely affect operations[180]. - The reliance on third-party manufacturers poses risks, including potential delays in clinical trials and regulatory submissions if agreements are breached or terminated[224]. - The company may need to conduct additional studies if adverse side effects are identified during clinical trials, which could further delay regulatory approval[213]. - The company may not achieve projected development goals, potentially delaying product commercialization[208]. - Regulatory inspections may lead to temporary or permanent discontinuation of clinical trials if compliance issues are identified[204]. - Previous clinical trial results may not predict future outcomes, with potential setbacks occurring at any stage of the clinical trial process[205]. - The company may face challenges in recruiting suitable patients for clinical trials, which could delay the overall development timeline[202].

Core Viewpoint - Marker Therapeutics, Inc. is actively participating in the H.C. Wainwright 3 Annual Cell Therapy Virtual Conference to present its advancements in T cell-based immunotherapies for treating hematological malignancies and solid tumors [1][2]. Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focusing on next-generation T cell-based immunotherapies [4]. - The company was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating that its autologous and allogeneic MAR-T cell products are well tolerated and show durable clinical responses [4]. - The company aims to introduce novel T cell therapies to the market while prioritizing financial resource preservation and operational excellence [4]. - Marker Therapeutics benefits from non-dilutive funding from U.S. state and federal agencies that support cancer research [4]. Event Details - Dr. Juan Vera, President and CEO of Marker Therapeutics, will present at the H.C. Wainwright 3 Annual Cell Therapy Virtual Conference on February 25, 2025, at 3:30 PM ET [2][3]. - The event will be held virtually, and registered participants can access the presentation through the event portal [3].

Core Viewpoint - Marker Therapeutics, Inc. has announced a private placement resulting in gross proceeds of $16.1 million to support the clinical advancement of its Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or are ineligible for it [1][2]. Financing Details - The financing will support the collection of additional clinical data for Marker’s lead clinical asset in lymphoma, MT-601 [3]. - The company is selling 5,031,250 shares of common stock at a purchase price of $3.20 per share, along with accompanying warrants [4]. - The pre-funded warrants will be exercisable at a price of $0.001 per share, while the accompanying warrants will have an exercise price of $4.03 per share [5]. Clinical Study Information - MT-601 is a multi-antigen recognizing (MAR) T cell product targeting six different tumor antigens upregulated in lymphoma cells [8]. - The APOLLO trial is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma [9]. - The trial aims to enroll approximately 30 participants across nine clinical sites in the United States during the dose escalation phase [9]. Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, focusing on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [12]. - The company’s unique T cell platform is supported by non-dilutive funding from U.S. state and federal agencies [12].

Core Insights - The APOLLO study demonstrates promising efficacy and safety for MT-601 in patients with relapsed lymphoma, with 78% of patients achieving objective response rates and 44.4% showing complete response [1][4][10] Safety - MT-601 infusion was well tolerated among all participants, with no cases of immune-effector cell associated neurotoxicity syndrome (ICANS) reported and only one instance of Grade 1 cytokine release syndrome (CRS) [3][11] - No dose limiting toxicities (DLTs) have been reported to date [3] Efficacy - In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at the first response assessment, with 4 patients demonstrating complete response (CR; 44.4%) [4][7] - Immunomonitoring data indicated that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo [2] Follow-Up - Long-term follow-up data is available for three patients, with ongoing visits to assess the durability of responses [5][8] - The longest follow-up period recorded is 12 months for one patient, with two patients showing complete response (CR) and partial response (PR) at 6 months [8] Company Overview - Marker Therapeutics, Inc. is focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, with MT-601 being a multi-antigen recognizing (MAR) T cell product targeting six tumor antigens [13][16] - The APOLLO trial is a Phase 1, multicenter, open-label study evaluating the safety and efficacy of MT-601 in patients with relapsed or refractory lymphoma who have failed or are ineligible for anti-CD19 CAR-T cell therapy [14]

Core Viewpoint - Marker Therapeutics, Inc. has received a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of its lead product MT-601 in patients with metastatic pancreatic cancer [1][5]. Group 1: Grant and Study Details - The CPRIT grant will support the Phase 1 PANACEA study, which evaluates the safety and tolerability of MT-601, a multi-tumor associated antigen-specific T cell product, in patients with metastatic pancreatic cancer [2]. - The company has received over $30 million in non-dilutive funding from various governmental institutions, including a recent $2 million grant from the NIH Small Business Innovation Research (SBIR) program [5][6]. Group 2: Product and Clinical Background - MT-601 is currently being studied for CD19-CAR relapsed lymphoma and has shown preliminary safety and efficacy with sustained objective responses in three participants [3]. - Previous studies have indicated that MT-601 can target multiple tumor-specific antigens, which may allow its application in solid tumors beyond lymphoma [4][9]. - A prior study at Baylor College of Medicine demonstrated favorable safety and durable cancer control in patients with pancreatic cancer treated with multiTAA-specific T cells [4]. Group 3: Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [11]. - The company aims to introduce novel T cell therapies to the market while preserving financial resources and ensuring operational excellence [11].

Core Viewpoint - Marker Therapeutics, Inc. has received a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of its lead asset MT-601 in patients with metastatic pancreatic cancer [1][5]. Funding and Grants - The CPRIT grant will support the Phase 1 PANACEA study evaluating the safety and tolerability of MT-601 in patients with metastatic pancreatic cancer [2]. - Including the CPRIT grant, the company has secured over $30 million in non-dilutive funding from various governmental institutions, including a recent $2 million grant from the NIH Small Business Innovation Research (SBIR) program [5][6]. Clinical Trials and Research - MT-601 is currently being studied in patients with CD19-CAR relapsed lymphoma, with preliminary safety and efficacy data showing sustained objective responses in three participants [3]. - Previous studies at Baylor College of Medicine indicated that multiTAA-specific T cells, similar to MT-601, demonstrated a favorable safety profile and durable cancer control in pancreatic cancer patients [4]. Product Overview - MT-601 is a multi-tumor associated antigen (multiTAA)-specific T cell product that targets six different tumor antigens upregulated in cancer cells [7]. - The product utilizes a non-genetically modified approach, which may offer easier and less expensive manufacturing with an improved safety profile compared to current engineered T cell therapies [8]. Company Background - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [9]. - The company aims to introduce novel T cell therapies to the market while prioritizing financial resource preservation and operational excellence [9].

Corporate Updates - Marker Therapeutics, Inc. is making significant progress in its Phase 1 APOLLO study of MT-601 for lymphoma patients who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T is not an option, with preliminary safety and efficacy data expected by the end of 2024 [2][3] - The company received two $2 million Small Business Innovation Research (SBIR) grants from the NIH to support the development of MT-601 in non-Hodgkin's lymphoma and pancreatic cancer [2][4] Program Updates - The Phase 1 APOLLO study is ongoing, with sustained objective responses observed in three participants, and no severe adverse effects reported [3] - The clinical investigation of MT-601 in metastatic pancreatic cancer is expected to start in 2025 [4] - Marker anticipates initiating the clinical program for MT-401-OTS in Acute Myeloid Leukemia or Myelodysplastic Syndrome in the first half of 2025 [5] Financial Highlights - As of September 30, 2024, Marker had cash and cash equivalents of $9 million, which is expected to fund operations into October 2025 [6] - Research and development expenses for Q3 2024 were $3.5 million, up from $2.0 million in Q3 2023, reflecting increased clinical trial activity [7] - General and administrative expenses decreased to $0.9 million in Q3 2024 from $1.4 million in Q3 2023 due to cost savings from a reorganization [7] - The net loss from continuing operations for Q3 2024 was $2.3 million, compared to $3.0 million in Q3 2023 [8] Revenue and Operating Expenses - Total revenues for Q3 2024 were $1.93 million, significantly higher than $0.26 million in Q3 2023, primarily due to increased grant income [15] - Total operating expenses for Q3 2024 were $4.33 million, compared to $3.46 million in Q3 2023 [15] T Cell Therapy Platform - Marker Therapeutics' multiTAA-specific T cell platform is a novel, non-genetically modified cell therapy that expands tumor-specific T cells capable of recognizing a broad range of tumor antigens, potentially offering improved safety and clinical benefits [9][10]

Revenue Generation - The company did not generate any revenue during the three months ended September 30, 2024 and 2023 from the sales or licensing of its product candidates [110]. - The company recognized $0.9 million and $0.2 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a $13.1 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) [111]. - The company recognized $0.02 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a $2.0 million grant from the FDA's Orphan Products Grant program [112]. - The company recognized $0.3 million of revenue during the three months ended September 30, 2024, associated with a $2.0 million grant from the National Institutes of Health SBIR program, while no revenue was recognized in the same period of 2023 [113]. - Grant income for the three months ended September 30, 2024, was $1,926,000, a 647% increase from $258,000 in the same period of 2023 [114]. - Total revenues for the three months ended September 30, 2024, were $1,926,000, reflecting a 647% increase compared to $258,000 in the prior year [114]. - Grant income for the nine months ended September 30, 2024, was $4,339,000, a 92% increase from $2,255,000 in the same period of 2023 [130]. - The company recorded $0.9 million and $2.4 million of grant income related to the CPRIT grant as revenue during the three and nine months ended September 30, 2024, respectively [146]. Expenses and Losses - The company incurred $1.2 million and $3.1 million in expenses related to services and manufacturing costs for the three and nine months ended September 30, 2024, respectively [101]. - Research and development expenses increased by 70% to $3,471,000 for the three months ended September 30, 2024, up from $2,045,000 in the same period of 2023 [117]. - General and administrative expenses decreased by 39% to $855,000 for the three months ended September 30, 2024, compared to $1,413,000 in the same period of 2023 [119]. - Total operating expenses for the three months ended September 30, 2024, were $4,326,000, a 25% increase from $3,458,000 in the same period of 2023 [114]. - Loss from operations for the three months ended September 30, 2024, was $(2,400,000), a 25% improvement from $(3,200,000) in the same period of 2023 [114]. - Total operating expenses for the nine months ended September 30, 2024, were $11,597,000, a 17% decrease from $13,898,000 in the same period of 2023 [130]. - Net loss from continuing operations for the nine months ended September 30, 2024, was $(6,895,000), a 39% improvement from $(11,305,000) in the same period of 2023 [130]. - Operating expenses for the three and nine months ended September 30, 2024, were $4.3 million and $11.6 million, respectively, compared to $3.5 million and $13.9 million in the prior year periods [152]. Grants and Funding - The company received a $2.0 million grant from the National Institutes of Health SBIR Program in August 2024 to support the advancement of MT-601 in patients with pancreatic cancer [107]. - The company received notice of a $2.0 million grant from the National Institutes of Health SBIR Program to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma who have relapsed following anti-CD19 CAR T cell therapy [108]. - The company received a $2.0 million grant from the FDA's Orphan Products Grant program for the clinical investigation of MT-401, with $1.0 million received to date [147]. - The company has received a total of approximately $13.1 million from the CPRIT grant, with $9.7 million received to date [146]. Financial Position - Cash and cash equivalents as of September 30, 2024, were $9,000,000, down from $15,111,000 as of December 31, 2023 [137]. - As of September 30, 2024, the company had working capital of $7.4 million, down from $14.1 million as of December 31, 2023 [152]. - The company anticipates needing substantial additional funding for ongoing operations and may need to raise capital sooner than planned [152]. - The company has entered into an ATM Agreement allowing for the sale of up to $75.0 million in common stock, with net proceeds of approximately $37,000 from sales during the nine months ended September 30, 2024 [156]. Organizational Changes - The company implemented organizational changes in 2023, including a reduction in headcount and the appointment of Dr. Juan Vera as President and CEO [103]. - The company executed a one-for-ten reverse stock split on January 26, 2023, reducing the total number of authorized shares from 300 million to 30 million [106]. Market Conditions - High inflation and economic recession concerns have resulted in capital market volatility, potentially affecting the company's liquidity [155]. - The company plans to continue funding operations through equity and/or debt financing, which may dilute existing stockholders' interests [154].

Financial Performance - Total revenues for the three months ended June 30, 2024, were $1,169,000, representing a 53% increase from $763,000 in the same period of 2023[86]. - Total revenues for the six months ended June 30, 2024, were $2.4 million, a 21% increase from $2.0 million in the same period in 2023[93]. - Loss from operations improved by 44%, decreasing to $(2,308,000) in Q2 2024 from $(4,134,000) in Q2 2023[86]. - The net loss from continuing operations decreased by 45% to $4.6 million for the six months ended June 30, 2024, from $8.3 million in the same period in 2023[93]. Operating Expenses - Operating expenses decreased by 29% to $3,477,000 in Q2 2024 from $4,897,000 in Q2 2023, with general and administrative expenses dropping by 55%[86]. - Operating expenses for the three months ended June 30, 2024, were $3.5 million, a decrease from $4.9 million in the same period in 2023[89]. - Total operating expenses for the six months ended June 30, 2024, were $7.3 million, down 30% from $10.4 million in the same period in 2023[96]. - Operating expenses for the three and six months ended June 30, 2024 were $3.4 million and $7.2 million, respectively, compared to $4.9 million and $10.4 million in the prior year periods, indicating a decrease of approximately 30.6% and 30.6%[111]. Interest Income - Interest income increased significantly by 229% to $115,000 in Q2 2024 compared to $35,000 in Q2 2023[86]. - Interest income increased by 127% to $272,000 for the six months ended June 30, 2024, compared to $120,000 in the same period in 2023[93]. Grants and Revenue Recognition - The company recognized $0.7 million in revenue from the CPRIT grant for both Q2 2024 and Q2 2023, with additional revenue from FDA and NIH grants totaling $0.2 million and $0.2 million respectively in Q2 2024[87][88]. - The company has received a total of $13.1 million in grants from CPRIT to support the clinical investigation of MT-401, with $9.7 million received to date[107]. - The company recognizes revenue from grant income when qualifying costs are incurred, reflecting its critical accounting estimates[117]. Cash and Liquidity - Cash and cash equivalents as of June 30, 2024, were $7.8 million, down from $15.1 million as of December 31, 2023[101]. - As of June 30, 2024, the company had working capital of $9.7 million, down from $14.1 million as of December 31, 2023[111]. - The company expects its cash and cash equivalents will fund operations into the fourth quarter of 2025[100]. - The company expects its cash and cash equivalents as of June 30, 2024 to fund operating expenses and capital expenditures into Q4 2025, although this estimate is subject to change[111]. Organizational Changes - Organizational changes in 2023 included a reduction in headcount and the appointment of Dr. Juan Vera as President and CEO[82]. Product Development - The company is advancing two product candidates for clinical indications: MT-601 for lymphoma and pancreatic cancer, and MT-401-OTS for various indications[72]. Financing and Market Conditions - The company plans to fund operations and capital needs through equity and/or debt financing, which may dilute existing stockholders' ownership[113]. - High inflation and economic recession concerns have led to capital market volatility, potentially affecting the company's liquidity[114]. - The company may need additional funds sooner than planned to meet operational needs and capital requirements for product development and commercialization[111]. - The company is unable to estimate the actual amounts necessary for the development and commercialization of product candidates due to the early stages of clinical development[112]. Stock and Shareholder Matters - A reverse stock split of 1-for-10 was executed on January 26, 2023, reducing the total number of authorized shares from 300 million to 30 million[84]. - The company sold 8,178 shares under the ATM Agreement during the six months ended June 30, 2024, resulting in net proceeds of approximately $37,000 after agent commissions[115]. - The company has the right to sell up to $25 million of shares to Lincoln Park Capital Fund, LLC, but terminated this Purchase Agreement effective March 1, 2024[116].