This Quarterly Report on Form
10-Q,
or this Quarterly Report, contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this Quarterly Report include, among other things, statements about:
| • | the initiation, timing, progress and results of our research and development programs and preclinical studies and clinical trials, including the timing of our planned Phase 3 clinical trial of sutacimig in patients with Glanzmann thrombasthenia; |
| • | our estimates regarding expenses, future revenue, capital requirements, need for additional financing and the period over which we believe our cash, cash equivalents, and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements; |
| • | the timing of and our ability to complete clinical development of, submit applications for and obtain and maintain regulatory approvals for our current and future product candidates; |
| • | the potential advantages of our current and future product candidates; |
| • | our plans to develop and, if approved, subsequently commercialize any product candidates we may develop; |
| • | the rate and degree of market acceptance and clinical utility of our products, if approved; |
| • | our estimates regarding the addressable patient population and potential market opportunity for our current and future product candidates; |
| • | our expectations regarding our ability to obtain and maintain intellectual property protection and to remain in compliance with our existing license agreements; |
| • | our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; |
| • | our expectations regarding milestone and/or royalty payments under any of our current or future license agreements; |
| • | the impact of government laws and regulations, including any new regulatory requirements in the countries in which we operate; |
| • | our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available; |
| • | our reliance on and the performance of third parties that conduct clinical trials of our product candidates and manufacture our product candidates; |
| • | our ability to identify, establish and maintain collaborations or obtain additional funding; |
| • | general economic, industry and market conditions, including rising interest rates, inflation and tariffs; and |
| • | our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a smaller reporting company. |
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in this Quarterly Report, particularly in Item 1A. “Risk Factors” in this Quarterly Report, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a competitive and rapidly changing environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties that could have an impact on us, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments we may make or enter into.
You should read this Quarterly Report and the documents that we have filed or incorporated by reference as exhibits to this Quarterly Report with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
