67 WALL STREET, New York - August 29, 2012 - The Wall Street Transcript has just published its Medical Research, Diagnostic Substances and Life Science Tools offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Health Care Consolidation Activity - Cost Reduction and Improving Efficiencies - Chinese CRO Growth - NIH Budget Uncertainty
Companies include: Cleveland BioLabs, Inc. (CBLI) and many others.
In the following excerpt from the Medical Research, Diagnostic Substances and Life Science Tools Report, the CEO of Cleveland BioLabs discusses the outlook for his company for investors.
TWST: Would you begin with a brief historical sketch of the company and a picture of its current operations at the present time?
Dr. Kogan: Cleveland BioLabs is a clinical-stage biotechnology company focused on oncology and orphan drug development. We were founded in 2003 and have collaborative relationships with the Cleveland Clinic, Roswell Park Cancer Institute and Children's Cancer Institute Australia, among others.
We have nine compounds in different stages of clinical or preclinical development, and that's very important to an investing audience, because this is quite a large number of drugs for a small biotech company. We have created specialized joint-venture subsidiaries to manage development, complexity of development and address funding concerns.
Our lead drug candidate, CBLB502, is in the advanced stages of clinical development for an initial indication as a medical radiation countermeasure. It's also in an earlier stage of clinical development as a cancer treatment. But there are eight other candidates, too. We're trying to push forward a diverse and innovative portfolio, which we believe would be very attractive for goal-oriented investors.
We have two major goals in mind. Our short-term goal is to reach FDA licensure of CBLB502 as a medical radiation countermeasure to fulfill this unmet medical need, and generate potential sales from U.S. and foreign governments. Our long-term goal is to realize a diverse oncology pipeline to get into the multi-billion-dollar global oncology market, to provide patients with powerful, novel treatments and generate significant return for our investors.
TWST: You became interim CEO in January 2012 and CEO in June. What are some of your key initiatives over the short term as you take over that role?
Dr. Kogan: My major drive is to maintain a laser focus on our short-term goal - licensure of CBLB502 as a medical radiation countermeasure. We have a very knowledgeable and well-trained group of senior managers who are responsible for the technical aspects of the drug-development process for all nine compounds. And we have people working on business development and corporate development to generate revenues and push us toward our long-term goal, which is to enter the oncology market.
TWST: What's the latest on the movement of the CBLB502 through the FDA approval process? Do you have a sense of what the timeline may look like?
Dr. Kogan: I'm pleased to say that in June we reported very strong survival results from our first clinical GLP trial in 179 nonhuman primates. The study not only met the primary end point, which is survival - nearly threefold in comparison to the control group - but it also defined the minimal efficacious dose and other pharmacodynamic parameters that are essential for animal-to-human dose conversion. The study was fully randomized, blinded and placebo controlled. It also included an unheard of number of nonhuman primates - we believe, the biggest study ever done in this setting. I believe it moves us forward to the next stage of development, a few additional pivotal animal studies.
We also held multiple meetings with the FDA in the first half of 2012, which helped us to come up with a proposed protocol for the remaining human safety study. We agree on major points related to our efficacy program. We are moving forward. We are on track and believe we will be able to complete all the remaining animal efficacy and human safety studies in 2012 and 2013, and file for approval in 2014.
TWST: You've said the company has received the clarity it has sought on that particular product from the FDA. What does that mean to the company?
For more from this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.