Recurrent Ewing Sarcoma

Elraglusib Demonstrated Anti-Tumor Activity with Two Ongoing Durable Complete Responses and ~62% Disease Control Rate in First 8 Patients with Relapsed/Refractory Ewing and Ewing-related SarcomasEnrollment Ongoing with Topline Data Anticipated in 1H 2025 CHICAGO and FORT WORTH, Texas, Sept. 09, 2024 (GLOBE NEWSWIRE) -- – Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma (r/r EWS). “Ewing sarcoma is a highly metastatic form of sarcoma and the second most prevalent primary malignant tumor in children and adolescents. There are currently no standardized second-line treatments for r/r EWS and the prognosis for these patients remains poor. There is an urgent need for new therapeutic strategies that combine novel targeted therapies with new mechanisms of action and existing chemotherapy regimens of established but limited efficacy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Elraglusib is one of the few novel targeted agents being pursued for the refractory EWS population and continues to show promise as a viable therapeutic option. Early clinical data suggest that the enhanced antitumor activity of chemotherapy observed in multiple preclinical refractory cancer models is translating well into clinical responses.” The ongoing Phase 1/2 Trial (NCT 04239092) is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS and EWS-related pediatric small round cell sarcomas. To date, the study has enrolled 6 patients with relapsed/refractory EWS (>1 remission); one patient with a desmoplastic small round cell tumor (DSRCT), an ultra-rare, highly aggressive pediatric sarcoma; and one patient with a CIC rearrangement. All patients were treated with elraglusib in combination with cyclophosphamide/topotecan. Two patients with recurrent /refractory EWS are experiencing ongoing complete responses (CR), two patients achieved stable disease (SD), and two patients withdrew from the study before their tumor response could be assessed (Table 1). The patient with Desmoplastic Small-Round-Cell Tumor (DSRCT) achieved a partial response (PR) with a 52% reduction in tumor size but withdrew from the study and is now being followed for survival. Table 1. Summary of EWS and other small round cell sarcomas treated in Clinical Study 1902. PatientTumor TypeBest Overall ResponseOS (days)11EWSCR (CT and CMR by PET)Alive OS = 933 days2EWSCR (CMR by PET)Alive OS = 284 days3DSRCTPRAlive OS = 329 days4EWSSDOS = 177 days5EWSSDOS = 272 days6EWSNot Determined.Patient withdrew from the StudyAlive OS = 318 (LTFU)7EWSNot Determined.Patient withdrew from the StudyOS = 89 days8CIC-rearrangementNot Determined.Patient withdrew from the StudyN/A 1 As of most recent follow-up visits May – August 2024 “We are pleased to share our continued, promising progress with elraglusib in r/r EWS,” said Dr. Andrew Mazar, Actuate’s Scientific Co-Founder and Chief Operating Officer. “Although the sample size is small, we are encouraged by the disease stabilization and two ongoing complete responses observed, including one patient with an overall survival of over 2.5 years. These results are considered promising by clinical experts in pediatric oncology, particularly given the significant unmet medical need and lack of therapeutic alternatives in recurrent EWS, and support the continued development of elraglusib in this rare cancer patient population.” The 1902 study remains open only to patients with recurrent EWS, who will be treated with the combination of elraglusib with cyclophosphamide/topotecan. The study will enroll up to 12 total EWS patients to provide additional rationale for moving the elraglusib/cyclophosphamide/topotecan combination into a phase 2 study in patients with recurrent EWS. Actuate plans to meet with the FDA to discuss the design of a phase 2 study and options for accelerating the development path for elraglusib to commercial registration for the treatment of EWS. About Ewing Sarcoma Ewing sarcoma (EWS) is a highly metastatic form of sarcoma that ranks as the second most prevalent primary malignant tumor of childhood and adolescence originating in bone with a peak incidence at the age of 15 years. Approximately 25% of new EWS patients have metastatic disease when first diagnosed, which is the most significant predictor of poor survival. Treatment options for relapsed/refractory metastatic EWS are limited. Despite intensive therapy, recurrent EWS, whether local or with distant metastases, is almost always fatal. While the use of chemotherapy regimens in conjunction with surgery has resulted in the 5-year survival rate increasing from 59 to 78% in children and young adolescents, and from 20 to 60% in adults, to date, no standard treatment has been defined in the relapsed/refractory setting. About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug product, elraglusib (a novel GSK-3 inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DDR pathways. For more information on the 1902 Study, please visit ClinicalTrial.gov and reference Identifier NCT04239092. Forward-Looking Statements This press release contains forward-looking statements about us, including our clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve favorable results in clinical trials or preclinical studies or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for phase 2 or other development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; and our ability to fund development activities. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Risk Factors” in our final prospectus filed with the SEC on August 13, 2024 pursuant to Rule 424(b)(4) under the Securities Act with respect to our Registration Statement on Form S-1 (File No. 333-279734) and other filings with the SEC. You should assume that the information appearing in this press release is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. Investor Contact Mike MoyerManaging DirectorLifeSci Advisors, LLCmmoyer@lifesciadvisors.com

Company’s therapeutic dendritic cell-based vaccine technology aims to offer new treatment options for children with recurring metastatic Ewing sarcoma and osteosarcoma LOS ANGELES--(BUSINESS WIRE)-- CellxLife today announced that Eric von Hofe, Ph.D., will serve as the company’s first Chief Executive Officer. The company was formed in late 2023 to advance a dendritic cell-based therapeutic vaccine candidate that aims to expand treatment options for children with recurring metastatic Ewing sarcoma and osteosarcoma. There are currently very few treatment options for children suffering from metastatic Ewing sarcoma or osteosarcoma. The most common treatment is surgical removal of the tumors in combination with radiation and chemotherapy. For children with recurring metastatic Ewing sarcoma or osteosarcoma, the 5-year survival rate is usually 20-30% and in the U.S., approximately $750,000 is spent on treatment over the course of a patient’s life. i,ii “Ewing sarcoma and osteosarcoma are devastating diseases that have far-reaching impact, particularly in pediatric patients and their caregivers,” said Dr. von Hofe. “I am honored to join the CellxLife team to help advance efforts in bringing this promising new biotherapeutic to the thousands of children and families fighting these cancers globally.” Through CellxLife’s proprietary platform, dendritic cells are taken from the body and presented with the patient’s own tumor cell antigens, then re-administered back into the body as an immunotherapeutic vaccine to educate the immune system. Study data generated to date has indicated that this both activates immune cells to attack remaining cancer cells in the body and shapes the immunological memory to greatly reduce the chances of cancer recurrence. In a prior Phase 1 study, 75% of pediatric participants diagnosed with metastatic Ewing’s or osteosarcoma, who responded well to surgery, overcame their cancer, and are still alive today. Out of all the participants in the trial, 62.5% of children with metastatic osteosarcoma who were treated with the dendritic cell-based therapy lived for more than 15 years. The CellxLife clinical team believes the therapy can cross over to other solid tumors, such as ovarian, breast, colorectal, pancreatic, glioblastoma, lung, and other solid tumors. The principle is the same; once a tumor is removed, the vaccine will shape the immunological memory of the cancer cells in the lymph nodes and greatly reduce the chances of cancer recurrence. “This could be a breakthrough for anyone who is faced with the horrible realization that cancer could reoccur after their tumor is removed,” said Ruvin Orbach, founder of CellxLife. “It’s an honor to have Eric on board as CEO at this important time of growth for CellxLife. We are committed to building the team and raising the capital required to further advance this de-risked therapeutic candidate. We are currently planning the Phase II trials with an orphan designation and significantly reducing the regulatory pathway for this promising immunotherapy.” Dr. von Hofe has over 30 years of experience in managing and overseeing biotechnology programs, with a focus on cancer immunotherapy and technology development. Most recently he led development efforts at AffyImmune Therapeutics where he oversaw the clinical development and orphan designation for a novel CAR-T cell therapeutic targeting refractory thyroid cancer. Previously, he was at Antigen Express where he led the development of an immunotherapeutic vaccine for breast and prostate cancer, resulting in a collaboration with Merck. Prior to that, he worked at Millennium Pharmaceuticals first as Program Director for Target Validation and later as Director of Programs & Operations, Discovery Research. Previously, Dr. von Hofe was Director, New Targets at Hybridon, Inc., where he coordinated in-house and collaborative research that validated gene targets for novel antisense medicines. Dr. von Hofe also held the position of Assistant Professor of Pharmacology at the University of Massachusetts Medical School, where he received a National Cancer Institute Career Development Award for defining mechanisms by which alkylating carcinogens create cancers. He received his Ph.D. in Experimental Pathology from the University of Southern California and was a postdoctoral fellow at both the University of Zurich and Harvard University School of Public Health. For more information, please visit . About CellxLife CellxLife is a Phase I/II-stage biotechnology company founded in 2023 to acquire promising biotherapies and accelerate their regulatory approval. The company’s initial program is focused on advancing a dendritic cell-derived vaccine therapy targeting metastatic Ewing sarcoma and osteosarcoma. The company is also currently planning a basket trial for five other solid tumor indications. Based in Los Angeles, California, CellxLife can be found online at . ____________________ i ii

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