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Pharmacist at Work

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Forward Looking Statements

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This website contains forward-looking statements about Stramsen Biotech Inc. (“Stramsen,” the “Company,” “we,” “us,” or “our”). All statements other than statements of historical fact are forward-looking statements, including statements concerning our business strategy, financial condition, capital requirements, financing plans, use of proceeds, product candidates, development activities, 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 not all forward-looking statements contain these words.

 

Our forward-looking statements include expectations regarding:

 

  • The development of SBX-1977, our investigational topical botanical wound-healing gel, and our other plant-derived product candidates;

 

  • The completion, timing, and results of formulation, manufacturing, analytical, nonclinical, and other development activities;

 

  • The preparation and submission of an investigational new drug application (“IND”) for SBX-1977, including the timing and outcome of FDA review and any requests for additional information or studies;

 

  • The proposed timing, location, design, authorization, enrollment, conduct, and results of clinical trials, including our plan to initiate a combined Phase 1/2 trial of SBX-1977 in January 2027 and our evaluation of international trial locations, including Australia;

 

  • Whether data from clinical trials conducted outside the United States may support future FDA submissions;

 

  • The timing and likelihood of obtaining regulatory approvals for any product candidate;

 

  • Our ability to secure sufficient financing, including through a potential public offering or our share subscription facility, subject to applicable terms and conditions, and to use any proceeds as planned;

 

  • Our ability to establish suitable manufacturing processes, obtain necessary materials, and collaborate with research institutions, clinical sites, contract research organizations, manufacturers, and other third parties;

 

  • Our ability to protect our intellectual property, retain qualified personnel, and expand our facilities and operations; and

 

  • The size of potential markets, future demand, competition, and the potential commercialization of our product candidates.

 

These statements reflect our expectations and assumptions as of the date they are made and are subject to risks and uncertainties that could cause actual results to differ materially. These include the risks described under “Risk Factors” and elsewhere on this website, as well as in any applicable Company filings with the Securities and Exchange Commission.

 

Development activities may take longer or cost more than anticipated, and nonclinical or clinical results may be unfavorable or inconclusive. Regulatory authorities may require additional studies, manufacturing information, or changes to proposed development plans. We may be unable to obtain necessary regulatory and ethics approvals, enroll sufficient participants, secure financing, or meet anticipated timelines. Prior human use of a plant or related preparation does not establish the safety or effectiveness of our product candidates or eliminate applicable development and regulatory requirements.

 

FDA 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. The proposed Phase 1/2 trial remains subject to financing, completion of required development and manufacturing activities, and applicable regulatory and ethics approvals. There can be no assurance that we will submit an IND on our anticipated schedule, initiate the proposed trial in January 2027, obtain favorable results, or receive approval to market any product candidate. Acceptance of data from trials conducted outside the United States will depend on applicable FDA requirements and review.

 

Forward-looking statements speak only as of the date they are made. Readers should not place undue reliance on these statements. We undertake no obligation to publicly update or revise any forward-looking statement to reflect subsequent events, circumstances, or changes in expectations, except as required by applicable law.

 

 

 

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