ADDED
As of March 20, 2026, there were 57,891,493 shares of the registrant s common stock, $0.001 par value per share, outstanding.
These forward-looking statements include, but are not limited to, statements about: our estimates regarding expenses, future revenue and capital requirements and our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents; the initiation, timing, design, progress and results of any preclinical studies and clinical trials, and our research and development programs; the regulatory path forward for tebipenem HBr and the potential approval of tebipenem HBr by the U.S.
These risks and uncertainties include, but are not limited to, the following: As of March 2025, we have ceased development of our SPR206 program, and as of November 2025, we have ceased development of our SPR720 oral program, and have shifted our focus and resources to advancing the development of the tebipenem HBr program, as well as other corporate activities.
If we fail to execute successfully on this re-prioritized strategic focus, or our collaboration with GSK fails to advance the development of the tebipenem HBr program, our business and prospects may be materially adversely affected.
Our ability to realize the value of tebipenem HBr depends on obtaining FDA approval.
If we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition.
If we are unable to raise capital when needed, or do not receive payments from our collaboration partnership agreements, it could limit our ability to support our operations.
We may not achieve the milestones triggering payments to us in our existing, or any future, license and collaboration agreements with third parties.
We contracted with third parties for the manufacture of clinical supplies of tebipenem HBr and expect to continue to do so in connection with any future clinical trials and commercialization of any potential product candidates.
Overview We are a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need.
REMOVED
As of March 21, 2025, there were 55,900,641 shares of the registrant s common stock, $0.001 par value per share, outstanding.
These risks and uncertainties include, but are not limited to, the following: Our ability to realize the value of tebipenem HBr depends on our commercial partner, GSK, obtaining FDA approval.
Pursuant to our previously announced restructuring, we have suspended development of our SPR720 oral program and have shifted our focus and resources to advancing the clinical development of our tebipenem HBr program, as well as other corporate activities.
If we fail to execute successfully on this re-prioritized strategic focus, our business and prospects may be materially adversely affected.
The report of our auditor on our consolidated financial statements expresses substantial doubt about our ability to continue as a going concern; if we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition.
If we are unable to raise capital when needed, or do not receive payment under our government awards or from our commercial partnership agreements, we could be forced to delay, reduce or eliminate our product development programs.
2 We may not achieve the milestones triggering payments to us in our license and collaboration agreements with third parties.
We contract with third parties for the manufacture of preclinical and clinical supplies of our product candidates and expect to continue to do so in connection with any future commercialization and for any future clinical trials and commercialization of our other product candidates and potential product candidates.
Our shares of common stock could be delisted from the Nasdaq GS, which could result in, among other things, a decline in the price of our common stock and less liquidity for holders of shares of our common stock.
We received a Wells Notice from the SEC contemplating a civil enforcement action, which could have a material adverse effect on our business, financial condition and results of operations, prospects, and/or our stock price.