Forward Looking Statements
Special Note Regarding Forward-Looking Statements
This prospectus contains forward-looking statements about Stramsen Biotech Inc. (“Stramsen,” the “Company,” “we,” “us,” or “our”). Statements other than statements of historical fact are forward-looking statements, including statements concerning our business strategy, financial condition, capital requirements, use of proceeds, product candidates, development plans, regulatory submissions, clinical trials, potential markets, and future operations. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “should,” “target,” and “will,” and similar expressions, may identify forward-looking statements, although some forward-looking statements do not contain these words.
Our forward-looking statements include expectations regarding:
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the development of SBX-1977, our topical botanical product candidate for wound healing, and our other plant-derived product candidates;
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the completion and results of formulation, manufacturing, analytical, nonclinical, and other development work;
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the preparation, timing, and submission of an investigational new drug application, or IND, for SBX-1977, and any FDA review, questions, or additional requirements;
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the proposed timing, location, design, authorization, enrollment, conduct, and results of clinical trials, including our current plan to initiate a Phase 1 trial of SBX-1977 in Australia in January 2027;
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whether data from a trial conducted outside the United States may support a future FDA submission;
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the timing or likelihood of obtaining regulatory approvals for any product candidate;
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our ability to obtain sufficient financing, including through this offering or our share subscription facility, and to use the proceeds as planned;
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our ability to establish suitable manufacturing processes, obtain necessary materials, and work with research institutions, clinical sites, manufacturers, and other third parties;
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our ability to protect our intellectual property, retain qualified personnel, and develop our facilities and operations; and
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the size of potential markets, future demand, competition, and any eventual commercialization of our product candidates.
These statements reflect our current expectations and assumptions. Actual results may differ materially because of risks and uncertainties, including those described under “Risk Factors” and elsewhere in this prospectus. Development work may take longer or cost more than expected. Nonclinical or clinical results may be unfavorable or inconclusive. Regulatory authorities may require additional studies, manufacturing information, or changes to our proposed development plans. We may be unable to obtain trial authorizations, enroll sufficient participants, secure needed financing, or meet our anticipated timelines. Prior human use of a plant or related preparation does not establish the safety or effectiveness of one of our product candidates or eliminate the need for applicable regulatory review.
The FDA’s feedback during pre-IND interactions does not constitute acceptance of an IND, authorization to begin a clinical trial, or approval of SBX-1977. None of our product candidates has been approved for commercial sale by the FDA or any other regulatory authority. There can be no assurance that we will submit an IND on our anticipated schedule, begin the proposed Phase 1 trial in January 2027, obtain favorable trial results, or receive approval to market any product candidate.
Forward-looking statements speak only as of the date they are made. We undertake no obligation to publicly update them to reflect later events or circumstances, except as required by applicable law. You should read this prospectus, including “Risk Factors,” and the exhibits to the registration statement of which it forms a part with the understanding that our actual results may differ materially from those expressed or implied by these statements.