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Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH), a micro-cap pharmaceutical company with a market capitalization of $3.12 million, has amended its agreement with contract research organization Theradex Systems, Inc. to expand a clinical trial for a potential cancer treatment.
The modification, effective February 1, 2025, was disclosed in a recent 8-K filing with the Securities and Exchange Commission. According to InvestingPro analysis, the company faces significant financial challenges, with a current ratio of 0.22 indicating potential liquidity concerns.
The change order, dated January 23, 2025, pertains to a Phase 2 clinical study of Ropidoxuridine, a drug intended to enhance the effectiveness of radiation therapy in patients with a specific type of brain cancer—newly diagnosed IDH-wildtype glioblastoma with an unmethylated MGMT promoter. The update includes an increase in the patient count from 15 to 16, to account for the addition of a replacement patient.
Additionally, the number of sites involved in the "Phase 2 - Start up" phase will grow from four to six, with the inclusion of one more investigator site and additional safety teleconferences to allow for medical monitor review prior to each meeting. The expansion comes as the company reports an EBITDA of -$7.2 million in the last twelve months.
The budget adjustments in the change order reflect the increased number of sites and higher travel costs associated with additional site monitoring and regulatory visits. These changes are expected to enhance the study’s operational scope and data monitoring capabilities.
This expansion of the trial signifies Shuttle Pharmaceuticals’ commitment to advancing its research in the field of oncology. The company’s shares are publicly traded on The Nasdaq Stock Market under the ticker symbol SHPH. InvestingPro analysis suggests the stock is currently undervalued, though investors should note that the company is quickly burning through cash. InvestingPro subscribers have access to 11 additional key insights about SHPH’s financial health and market position.
The detailed terms of the change order have been partially redacted in the publicly filed document, as they are not deemed material and are typically kept confidential by the company. This filing is based on the press release statement and provides a factual summary of the company’s recent actions to advance its clinical research efforts.
In other recent news, Shuttle Pharmaceuticals has reached a pivotal point in its Phase 2 clinical trial for glioblastoma treatment, enrolling 25% of the participants. The trial is testing Ropidoxuridine, the company’s lead radiation sensitizer. This milestone comes amid financial challenges, with Shuttle Pharmaceuticals reporting an EBITDA of -$7.2 million over the last twelve months and a current ratio of 0.22, indicating potential liquidity issues.
The company has successfully completed a funding round, raising $790,000, anticipated to support ongoing research and development activities. In addition, Shuttle Pharmaceuticals secured a patent for selective histone deacetylase (HDAC) inhibitors, contributing to its mission to enhance cancer treatments.
Moreover, the company faces a potential Nasdaq delisting due to an equity shortfall and is exploring options to regain compliance. This comes as the company’s shareholders approved a one-for-eight reverse stock split and plans to restate its 2022 and first quarter 2024 financial statements due to identified accounting errors.
In other developments, Shuttle Pharmaceuticals has published research on a new compound, SP-1-303, showing potential in inhibiting the growth of estrogen receptor-positive breast cancer cells. The company also announced executive team changes, welcoming Timothy Lorber as the new Chief Financial Officer.
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