Innovation Pharmaceuticals CEO Letter to Shareholders—End-of-Year Highlights, Partnering Momentum Heading into 2018
Dear Shareholders:
As 2017 comes to a close, I wanted to take a moment to highlight some of our recent accomplishments and comment on potential developments heading into 2018. For a more detailed view of the complete year, we encourage interested parties to visit our web site investor’s page and view our latest corporate presentation at:
www.ipharminc.com
Clinical Programs
The Brilacidin Franchise (first-in-class immunomodulatory drug candidate)
Brilacidin-Oral Mucositis: Completed Phase 2 clinical trial; primary endpoint met showing a clear reduction in incidence of severe Oral Mucositis (SOM) in Head and Neck Cancer patients receiving chemoradiation compared to placebo; global patent protections; patient-friendly drug delivery improvements.
Meeting the primary endpoint of reduced incidence of SOM in this Phase 2 study was far more challenging than approaches taken for other drugs in development for this notoriously difficult indication. This feature of Brilacidin-OM greatly differentiates it from other experimental drugs that only address time to onset and duration of SOM. The Company believes our clinical results provide a clear path for expedient development and eventual marketing, which would represent the first drug of its kind to garner FDA approval. These study results position the Company as a global leader in developing a drug to prevent the onset of SOM. Management believes that the Company’s market capitalization has not yet reflected the value created by this accomplishment given the fact that there are no competing treatments in an untapped and enormous market. One need only speak with a radiation oncologist to realize the great need to protect against SOM of any origin and the potential sales for such a drug. Recent analyst reports estimate the global OM market at $1-2 billion per year.
Intellectual property protection was further reinforced this year with the granting of additional Brilacidin patents in the US, EU, and India.
Planning for patient-friendly drug product dosage forms better optimized for intended uses has led to consideration of Brilacidin sachets for use in OM.
Brilacidin-Inflammatory Bowel Disease (IBD): Completed Phase 2 proof-of-concept clinical trial in distal Colitis; a majority of patients treated with Brilacidin achieved clinical remission, supported by endoscopic improvement; transition to an oral formulation is planned to enable treatment of more extensive forms of IBD (i.e., Crohn’s Disease, Ulcerative Colitis).
Prurisol (first-in-class oral psoriasis drug candidate)
Completed Phase 2b clinical trial, enrolling 199 patients, of oral Prurisol in moderate-to-severe plaque Psoriasis; study increased the total daily oral dosing of Prurisol from an earlier Phase 2a trial in mild-to-moderate plaque Psoriasis; topline data anticipated to be released in Q1 2018.
Kevetrin (first-in-class p53-modulating oncology drug candidate)
Provided clinical update on first patients treated in Phase 2a clinical trial of Kevetrin for late-stage Ovarian Cancer; direct modulation of p53 observed in response to administration of Kevetrin, as well as concomitant cell cycle modulation at the level of gene expression; additional pre-clinical research supporting Kevetrin’s therapeutic potential presented at annual scientific meetings of the American Association for Cancer Research (AACR) and the European Hematological Association (EHA).
Business Development
To advance our pipeline in an expeditious manner, this year we placed an emphasis on partnering—actively engaging global and regional pharmaceutical companies interested in licensing our novel drug candidates. These efforts have led to highly productive, mature (late-phase, ongoing) discussions, with multiple pharmaceutical companies, which we hope will bear fruit in the coming year.
Partnerships would transform the Company overnight, providing: added validation for the pipeline; access both to upfront cash and potential future revenue streams; and expedited development of our clinical assets—all toward delivering needed treatments to patients, and tangibly rewarding our loyal shareholders.
In closing, we are extremely excited about the Company—both as to the progress made in 2017 and emerging developments as we enter 2018. We will be presenting at Biotech Showcase and attending the J.P. Morgan Healthcare Conference, this January in San Francisco, and look forward to updating shareholders via a corporate overview.
With gratitude, wishing all a happy and prosperous New Year.
Sincerely,
Leo Ehrlich, CEO
Forward-Looking Statements: This letter contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, 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 to Aspire Capital; 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.
Copyright © 2017 Innovation Pharmaceuticals, All rights reserved.
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