Organization and Description of Business, Liquidity, and Risk Factors |
3 Months Ended | |||
|---|---|---|---|---|
Mar. 31, 2026 | ||||
| Organization and Description of Business, Liquidity, and Risk Factors [Abstract] | ||||
| ORGANIZATION AND DESCRIPTION OF BUSINESS, LIQUIDITY, AND RISK FACTORS | NOTE 1 — ORGANIZATION AND DESCRIPTION OF BUSINESS, LIQUIDITY, AND RISK FACTORS
OS Therapies Incorporated (“we,” “us,” “our,” the “Company”) is a Delaware corporation incorporated on June 24, 2019. It is based in Rockville, Maryland. The Company is the successor to an LLC formed in 2018.
The Company intends to focus on the identification, development, and commercialization of treatments for Osteosarcoma and other related diseases. As of March 31, 2026, there is one ongoing clinical trial for Osteosarcoma therapy.
OS Animal Health Corp – Subsidiary
On June 25, 2025, the Company formed OS Animal Health Corp, a Delaware corporation and wholly owned subsidiary. The subsidiary had minimal activity during the three months ended March 31, 2026, consisting primarily of investor relations and audit-related expenses. During this period, the Company entered into a license agreement with the subsidiary, pursuant to which it granted the subsidiary rights to use the HER2 Assets (as defined below).
OS Therapies UK LTD – Subsidiary
On August 29, 2025, the Company formed OS Therapies UK LTD, a United Kingdom corporation and wholly owned subsidiary. This subsidiary serves as the Company’s research and development arm and had substantial operating activity during 2025. The Company has transitioned its research and development activities to this subsidiary and intends to enter into an intercompany loan agreement, which is currently pending.
Liquidity
The Company has prepared its consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred significant net losses and negative cash flows from operations. During the three months ended March 31, 2026, the Company incurred a net loss of $10.4 million and used $4.6 million in cash for operating activities.
As of March 31, 2026, the Company had cash and cash equivalents of $917,552. Management has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The Company’s current cash balance is insufficient to fund operations. During the three months ended March 31, 2026, the Company incurred significant expenses, primarily related to activities in preparation for potential regulatory approvals by the U.S. Food and Drug Administration and other countries regulatory authorities. The Company expects vendor and related costs associated with these efforts to total approximately $20.0 million and continue into the remainder of 2026. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the unaudited consolidated financial statements are issued.
The Company’s ability to continue as a going concern is dependent upon its ability to raise additional capital to fund its research and development and future operations. Management’s plans to mitigate these conditions include:
However, there can be no assurance that the Company will be successful in sequestering additional financing on favorable terms, or at all. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |