Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2 - Seite 3
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Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected.
Forward-looking statements include statements regarding the potency and potential neutralizing profile of STI-2020 and the impact on SARS-CoV-2; the preclinical testing of STI-2020; the safety,
pharmacokinetics and efficacy of STI-2020; the potential for STI-2020 to avoid antibody-dependent enhancement side effects; the expectation of the commencement of any pivotal trials for STI-2020;
the potential receipt of an EUA for STI-2020 and expected timing for any receipt thereof; the expected availability of doses of STI-2020 and the timing thereof; the belief that the IND addresses
all questions and recommendations from the FDA; the predictive value of the animal model used in preclinical studies; the proposed dosages in the phase 1 clinical trial; the potential potency of
STI-2020; the expected effective dose in humans; the expected administration method of STI-2020; the potentially faster manufacturing speed, availability and potential lower cost for STI-2020; and
Sorrento's potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking
statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates' and partners' technologies and prospects and collaborations with partners, including, but
not limited to risks related to conducting pre-clinical studies and seeking IND regulatory approval for STI-2020; conducting and receiving results of clinical trials for STI-2020; the clinical and
commercial success of STI-2020 against preventing and treating SARS-CoV-2 virus infections; the viability and success of STI-2020 in anti-viral therapeutic areas, including coronaviruses; clinical
development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals;
risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that
prior test results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries,
affiliates and partners to assist the company in the execution of its COVID-19 therapeutic product candidates strategies; risks related to the global impact of COVID-19; and other risks that are
described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31,
2019, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to
place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press
release except as required by law.