Note 2. Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements do not include all the information and notes required by Generally Accepted Accounting Principles (“GAAP”) in the U.S. The accompanying year-end balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2026, the results of its operations for the three and six months ended June 30, 2026 and 2025 and its cash flows for the six months ended June 30, 2026 and 2025. The results for the three and six months ended June 30, 2026 are not necessarily indicative of results to be expected for the year ending December 31, 2026, any other interim periods or any future year or period. The accompanying unaudited interim condensed consolidated financial statements of the Company should be read in conjunction with the audited financial statements and notes thereto included in the

Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 27, 2026.

The accompanying condensed consolidated financial statements include the accounts for the Company and all entities where BTI has a controlling financial interest after elimination of all intercompany accounts and transactions and have been prepared in conformity with U.S. GAAP.

As of June 30, 2026, the Company had cash, cash equivalents and restricted cash of $13,801 and an accumulated deficit of $747,498. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $14,713 and $19,187 for the three months ended June 30, 2026 and 2025, respectively, and $27,404 and $26,441 for the six months ended June 30, 2026 and 2025, respectively, and had net cash used in operating activities of $17,907 and $24,618 for the six months ended June 30, 2026 and 2025, respectively.

Under ASC Topic 205-40, Presentation of Financial Statements - Going Concern, management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.

The Company’s history of significant losses, its negative cash flows from operations, its current debt obligations, potential near-term increased covenant-driven amortization payments under its Credit Agreement (as defined in Note 9, Debt and Credit Facilities), its limited liquidity resources currently on hand, and its dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in management’s assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the issuance date of the financial statements included in this Quarterly Report.

This going concern evaluation takes into consideration the potential mitigating effect of management’s Clinical Reprioritization (as defined in Note 4, Restructuring). When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans need to be approved by the Company’s Board of Directors. Although the Company has developed and implemented certain plans, they will not mitigate the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments that may result from the outcome of this uncertainty. The going concern analysis does not consider possible future amendments to or restructuring of the Credit Agreement (as defined in Note 9, Debt and Credit Facilities) or other potential sources of debt or equity capital.

Management and the Company’s board of directors, with the assistance of advisors, have been actively pursuing a sale, merger, or other strategic transaction and additional financing alternatives, but to date these efforts have not resulted in a signed definitive agreement or committed source of additional capital.

To date, the Company has continued research and development activities while managing its cash position. However, the Company requires additional funding to continue as a going concern and has been unsuccessful to date in securing sufficient additional funding, notwithstanding an active process to identify and complete a sale, merger, financing or other strategic transaction. If the Company does not complete a strategic transaction, or does not receive sufficient financing from other sources of equity or debt financings, the Company expects it will likely file for protection under the U.S. Bankruptcy Code. Even if the Company is successful in raising additional capital, it will

require substantial additional financing to service its debt facilities and achieve its goals and a failure to obtain this necessary capital when needed could force the Company to delay, limit, reduce or terminate its product development or commercialization efforts. In connection with its efforts to pursue strategic alternatives, the Company has engaged restructuring and financial advisory professionals and, together with our Lenders, is engaged in contingency planning, including discussions regarding the potential availability of debtor-in-possession financing, in the event a strategic transaction acceptable to the Lenders is not completed on or prior to August 21, 2026, as required pursuant to the Twelfth Amendment to the Credit Agreement described below. The Company has not made any determination to commence a bankruptcy proceeding, and there can be no assurance as to which, if any, of these alternatives will be pursued or completed. Further, certain strategic alternatives will require the consent of our Lenders pursuant to the covenants in the Company’s Credit Agreement.