"Dear Shareholder" letter from IPIX CEO.
Dear Innovation Pharmaceuticals Shareholder,
We trust that everyone is aware of the recent warning from the World Health Organization (WHO) regarding the Delta variant of COVID-19 that is spreading quickly throughout the world. We encourage everyone to review a MarketWatch article from Thursday, July 15 (link below) that provides insight on the new variant and statistics on rising rates of COVID-19 diagnoses and deaths worldwide. In the words of the WHO, “The pandemic continues to evolve with four variants of concern dominating global epidemiology,” “the pandemic is nowhere near finished,” and there is a “strong likelihood for the emergence and global spread of new and possibly more dangerous variants of concern that may be even more challenging to control.”
Variants have been a concern of ours from the outset, which keeps us driving forward as quickly as possible to develop Brilacidin as a new antiviral drug to destroy the resilient coronavirus.
As we announced last month, enrollment was completed to our 120-patient Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients. As such, we are now quickly approaching the last of the 60th day post treatment telephone follow-up visits with trial participants, which are scheduled to take place by the first week of August. As this important trial event nears, monitoring/ review/ data cleaning continues with close coordination between the data management and statistics groups to the goal of closure of the study database and output of study results.
The trial was a double-blind format, so no one at this point has any knowledge of the efficacy results for the groups – as to which patients received Brilacidin plus standard of care and which received standard of care alone. Per industry best practices, the complete data set from the trial will be verified to ensure integrity and then the unblinding process will begin. We greatly look forward to that day and, in the interim, remain hopeful that the trial will have met its efficacy and safety endpoints. There is clearly a desperate need for a new COVID-19 treatment and to have a potent drug ready for when the next viral outbreak inevitably occurs.
Upcoming Conferences: As previously released, independent research on Brilacidin’s in vitro broad-spectrum antiviral properties will be presented next week, at the American Society of Virology’s 40th Annual Meeting (ASV 2021), as well as in later August, at the U.S. Department of Defense-sponsored 2021 Military Health System Research Symposium. The Company will make available copies of the oral presentations the day after they are given. The Brilacidin findings discussed at these conferences are planned to be submitted for peer-review publication.
Link to MarketWatch article: https://www.marketwatch.com/story/u-s-covid-1...1626360879
Thank you for your continued support. Stay well.
Leo Ehrlich
Chief Executive Officer, Innovation Pharmaceuticals, Inc.
Forward-Looking Statements: This alert contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other viruses, as well as obtaining government regulatory approvals to commence clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Dear Innovation Pharmaceuticals Shareholder,
We trust that everyone is aware of the recent warning from the World Health Organization (WHO) regarding the Delta variant of COVID-19 that is spreading quickly throughout the world. We encourage everyone to review a MarketWatch article from Thursday, July 15 (link below) that provides insight on the new variant and statistics on rising rates of COVID-19 diagnoses and deaths worldwide. In the words of the WHO, “The pandemic continues to evolve with four variants of concern dominating global epidemiology,” “the pandemic is nowhere near finished,” and there is a “strong likelihood for the emergence and global spread of new and possibly more dangerous variants of concern that may be even more challenging to control.”
Variants have been a concern of ours from the outset, which keeps us driving forward as quickly as possible to develop Brilacidin as a new antiviral drug to destroy the resilient coronavirus.
As we announced last month, enrollment was completed to our 120-patient Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients. As such, we are now quickly approaching the last of the 60th day post treatment telephone follow-up visits with trial participants, which are scheduled to take place by the first week of August. As this important trial event nears, monitoring/ review/ data cleaning continues with close coordination between the data management and statistics groups to the goal of closure of the study database and output of study results.
The trial was a double-blind format, so no one at this point has any knowledge of the efficacy results for the groups – as to which patients received Brilacidin plus standard of care and which received standard of care alone. Per industry best practices, the complete data set from the trial will be verified to ensure integrity and then the unblinding process will begin. We greatly look forward to that day and, in the interim, remain hopeful that the trial will have met its efficacy and safety endpoints. There is clearly a desperate need for a new COVID-19 treatment and to have a potent drug ready for when the next viral outbreak inevitably occurs.
Upcoming Conferences: As previously released, independent research on Brilacidin’s in vitro broad-spectrum antiviral properties will be presented next week, at the American Society of Virology’s 40th Annual Meeting (ASV 2021), as well as in later August, at the U.S. Department of Defense-sponsored 2021 Military Health System Research Symposium. The Company will make available copies of the oral presentations the day after they are given. The Brilacidin findings discussed at these conferences are planned to be submitted for peer-review publication.
Link to MarketWatch article: https://www.marketwatch.com/story/u-s-covid-1...1626360879
Thank you for your continued support. Stay well.
Leo Ehrlich
Chief Executive Officer, Innovation Pharmaceuticals, Inc.
Forward-Looking Statements: This alert contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other viruses, as well as obtaining government regulatory approvals to commence clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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