Risks, Liquidity, and Going Concern (Q1) |
3 Months Ended | 12 Months Ended |
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Mar. 31, 2026 |
Dec. 31, 2025 |
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| Risks, Liquidity, and Going Concern [Abstract] | ||
| Risks, Liquidity, and Going Concern |
2. Risks, Liquidity, and Going Concern
The Company has incurred recurring losses and negative cash flows from
operations since inception and had an accumulated deficit of $712.3 million as of March 31, 2026. The Company anticipates incurring
additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional capital will be needed by the Company to fund its operations and to develop its
product candidates.
The Company’s operations have consisted primarily of conducting preclinical
studies, developing licensed technology, conducting clinical trials, and the development and manufacturing of clinical supply to support clinical trials. The Company faces risks associated with early-stage biotechnology companies whose product
candidates are in development. Product candidates currently under development will require significant additional research and development efforts and establishing manufacturing capacity and regulatory approval prior to commercialization. These
efforts require significant amounts of additional capital for the Company to complete its research and development, achieve its regulatory objectives, defend its intellectual property rights, and recruit and retain skilled personnel, and key
members of management. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
On March 5, 2021, the Company entered into a Sales Agreement, or the Sales
Agreement, with Cowen and Company, LLC, or Cowen, relating to the applicable terms of at-the-market equity offerings, or the ATM Facility, pursuant to which the Company may, but is not obligated to, offer and sell, from time to time, shares of
its common stock with an aggregate offering price up to $125.0 million through Cowen, as sales agent in the ATM Facility. The Company
is currently limited in its capacity to offer and sell shares of its common stock under the Sales Agreement pursuant to the prospectus supplement to its shelf registration statement on Form S-3, filed on March 4, 2024. As of March 31, 2026, $15.8 million of capacity remains available to be sold under the ATM Facility.
These financial statements have been prepared in accordance with U.S.
generally accepted accounting principles, or GAAP, assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. In
accordance with the Financial Accounting Standards Board’s, or FASB, Accounting Standards Codification, or ASC, Subtopic 205-40, Presentation of Financial Statements - Going Concern, the Company has
evaluated whether there are certain 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 the financial statements are
issued. The Company incurred net losses of approximately $7.6 million and $15.4 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, the Company had cash and cash equivalents totaling $33.3 million, which the Company does not expect to be sufficient to meet the Company’s capital requirements over the next 12 months.
As a result, there is substantial doubt about the Company’s ability to
continue as a going concern within one year after the date that these financial statements are issued. The financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported
expenses that may be necessary if the Company were unable to continue as a going concern.
On April 20, 2026, the Company announced that it has initiated a review of
strategic alternatives to maximize shareholder value (see Note 13). These strategic alternatives may include, but are not limited to, merger or acquisition transactions, a reverse merger, a sale of assets of the Company, strategic partnerships,
licensing opportunities, or other potential paths. The Company does not intend to provide updates on the strategic review until the board of directors approves a specific action or otherwise determines that disclosure is appropriate or
required. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances
or other arrangements on favorable terms, or at all. The terms of any
financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, or prospects of funding are unfavorable, the Company could be required to further delay, reduce or eliminate
research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects.
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2. Risks and Liquidity
The Company has incurred recurring losses and negative cash flows from
operations since inception and had an accumulated deficit of $704.8 million as of December 31, 2025. The Company anticipates
incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development. Substantial additional capital will be needed by the Company to fund its operations and to develop
its product candidates.
The Company’s operations have consisted primarily of conducting preclinical
studies, developing licensed technology, conducting clinical trials, and the development and manufacturing of clinical supply to support clinical trials. The Company faces risks associated with early-stage biotechnology companies whose product
candidates are in development. Product candidates currently under development will require significant additional research and development efforts and establishing manufacturing capacity and regulatory approval prior to commercialization. These
efforts require significant amounts of additional capital for the Company to complete its research and development, achieve its regulatory objectives, defend its intellectual property rights, and recruit and retain skilled personnel, and key
members of management. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
On March 5, 2021, the Company entered into a Sales Agreement, or the Sales
Agreement, with Cowen and Company, LLC, or Cowen, relating to the applicable terms of at-the-market equity offerings, or the ATM Facility, pursuant to which the Company may, but is not obligated to, offer and sell, from time to time, shares of
its common stock with an aggregate offering price up to $125.0 million through Cowen, as sales agent in the ATM Facility. The Company
issued 300,000 shares of its common stock under the ATM Facility, resulting in net proceeds of $8.7 million, after deducting offering costs of $0.3
million in March 2024. The Company is currently limited in its capacity to offer and sell shares of its common stock under the Sales Agreement pursuant to the prospectus supplement to its shelf registration statement on Form S-3, filed on
March 5, 2025.
The Company plans to seek additional funding through public or private equity
offerings, debt financings, other collaborations, strategic alliances and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances
or other arrangements on favorable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding or prospects of funding are unfavorable,
the Company could be required to further delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect its business prospects.
In accordance with the Financial Accounting Standards Board’s, or FASB,
Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements – Going Concern, the Company has evaluated whether there are certain 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 the financial statements are issued. As of the issuance date of these financial statements, the Company
expects that its cash and cash equivalents will be sufficient to fund its forecasted operating expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these financial statements.
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