On behalf of Batu Biologics, I am pleased to provide you with a year-end update recapping our progress in 2015 and overviewing our plans for 2016.
Main accomplishments in the past year include:
- Publication of a peer-reviewed scientific manuscript together with key opinion leaders in the area of tumor immunotherapy demonstrating proof of concept efficacy in three animal models of cancer using our ValloVax product1.
- Publication of a second manuscript providing scientific rationale and data supporting translation of the company’s ValloVax product into clinical trials2.
- Filing of 17 patents in the areas of anti-angiogenesis, cell therapy, and innate system immunotherapy. To-date Batu has filed a total of 21 patent applications.
- Granting of United States patent # 8,999,349 covering composition of matter claims for ImmXcyte™ immune-oncology peptide technology licensed exclusively from University of California San Diego (UCSD).
- Raised $1,275,000 in equity capital for a total of $1,850,000 raised to date.
- Completed key steps in preparation for initiation of clinical trials for the ValloVax program, including completion of cGMP manufacturing, completion of GLP toxicology studies, and recruitment of an internationally-renowned principal investigator.
- Filed responses to FDA questions regarding proposed Phase I clinical trial for ValloVax in patients with non-small cell lung cancer (NSCLC).
With the help and support of our board, scientific advisors, investors, and collaborators, we are excited to pursue the following objectives for 2016.
- Q1: FDA clearance for initiation of Phase I clinical trial for ValloVax in patients with NSCLC.
- Q1: Publication of pilot clinical data from Ex-US collaborative studies on ValloVax in cancer patients.
- Q2 Initiation of Phase I clinical trial for ValloVax.
I would like to thank you, our shareholders, for your unwavering support, which has allowed for the accelerated development of our novel cancer vaccine. I look forward to working closely with you in 2016 to bring our therapeutic candidates into the clinic and to substantially increase shareholder value.
Samuel C. Wagner
President and CEO
Safe Harbor Statement:
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Private Placement Memorandum. To the extent that statements in this press release are not strictly historical, including statements as to product launch timing, revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future collaboration agreements, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.