CHICAGO and FORT WORTH, Texas - Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company, has reported encouraging preliminary results from its Phase 1/2 trial of elraglusib for patients with relapsed/refractory Ewing Sarcoma (r/r EWS). The ongoing study has so far enrolled eight patients, with two experiencing ongoing complete responses and a disease control rate of approximately 62%.
Ewing sarcoma is a rare and aggressive cancer, primarily affecting children and adolescents, with a high rate of metastasis. Current treatment options for r/r EWS are limited, and the prognosis for these patients is typically poor. Elraglusib, a novel glycogen synthase kinase-3 beta (GSK-3β) inhibitor, is being tested in combination with the chemotherapy agents cyclophosphamide and topotecan.
The trial, which includes patients with EWS and EWS-related pediatric small round cell sarcomas, has shown two complete responses, with one patient achieving an overall survival of over 2.5 years. Additionally, a patient with Desmoplastic Small-Round-Cell Tumor (DSRCT) achieved a partial response with a 52% reduction in tumor size.
The company plans to enroll up to 12 total EWS patients in this trial to provide further data to support the continued development of elraglusib and to discuss the design of a phase 2 study with the FDA. The aim is to accelerate the development path for elraglusib towards commercial registration for EWS treatment.
Actuate Therapeutics emphasizes the need for new therapeutic strategies for r/r EWS, and the results from this trial are seen as a positive step towards addressing this unmet medical need.
The information reported is based on a press release statement from Actuate Therapeutics.
In other recent news, Actuate Therapeutics, a pharmaceutical company based in Fort Worth, Texas, has announced a significant change in its independent registered public accounting firm. The company has confirmed that KMJ Corbin & Company LLP, which has been providing accounting services to Actuate, has resigned and will be replaced by Crowe LLP effective immediately. This change follows the earlier transition of KMJ's partners and professional staff to Crowe LLP.
The decision to appoint Crowe as the new auditor for the fiscal year ending December 31, 2024, was made by Actuate's Audit Committee. It's important to note that KMJ's reports on Actuate's financial statements for the past two fiscal years did not contain any adverse opinion or disclaimer of opinion. However, the audit report included an explanatory paragraph regarding substantial doubt about Actuate Therapeutics' ability to continue as a going concern, a standard warning when a company may not have enough resources to sustain its operations in the long term.
The company also reported a material weakness in its internal control over financial reporting related to clinical trial expense accruals in its most recent Form S-1. Despite these concerns, Actuate Therapeutics has assured that there were no disagreements with KMJ on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure. These are the recent developments in the company's financial operations.
InvestingPro Insights
As Actuate Therapeutics (NASDAQ: ACTU) continues to make strides in the development of elraglusib for treating Ewing Sarcoma, investors and stakeholders closely monitor the company's financial health and market performance. According to InvestingPro data, Actuate Therapeutics currently holds a market capitalization of $155.76 million. Despite the promising clinical results, the company's financial metrics reflect some challenges, with an adjusted P/E ratio over the last twelve months as of Q1 2024 at -5.7, indicating that the company is not currently profitable.
InvestingPro Tips highlight several key points for potential investors to consider. Firstly, the Relative Strength Index (RSI) suggests that Actuate Therapeutics' stock is in overbought territory, which could signal a potential pullback in the stock price. Additionally, the company's gross profit margins are considered weak, and it does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income.
Furthermore, Actuate Therapeutics operates with a moderate level of debt and its short-term obligations exceed its liquid assets, which could pose liquidity risks. These financial insights, alongside the clinical developments, may guide investors in evaluating the company's prospects. For those interested in a more in-depth analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/ACTU, providing a comprehensive look at Actuate Therapeutics' financial and operational performance.
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