Cleveland BioLabs CEO Discusses Q2 2012 Results - Earnings Call Transcript

Cleveland BioLabs, Inc. (CBLI)

Q2 2012 Earnings Call

August 6, 2012, 10:30 a.m. ET


Rachel Levine – Director of IR & Communications

Yakov Kogan – CEO

C. Neil Lyons – CFO

Andrei Gudkov – CSO

Michael Fonstein – President

Michael Kurman – CMO

Ann Hards – EVP of Regulatory Affairs & QA


Walter Schenker - MAZ Partners

Chris Marai – Wedbush Securities

Robert Brous - Wunderlich Securities

Marty Meyerson - MH Meyerson & Company

Prashant Mehta - Netgain Financial

Bernie Brown – Private Investor



Greetings, and welcome to the Cleveland BioLabs Second Quarter 2012 Earnings

conference call. At this time, all participants are in a listen-only mode. A brief

question-and-answer session will follow the formal presentation. (Operator Instructions).

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ms. Rachel Levine, Director of Investor Relations and Communications for Cleveland BioLabs.

Thank you, Ms. Levine. You may begin.

Rachel Levine

Thank you, and good morning, everyone. Welcome to Cleveland BioLabs’ Second

Quarter 2012 Investor conference call. Joining us today are Dr. Yakov Kogan, Chief Executive Officer; Dr. Andrei Gudkov, Chief Scientific Officer; Dr. Michael Fonstein, President; Neil Lyons, Chief Financial Officer; Dr. Michael Kurman, Chief Medical Officer; Dr. Ann Hards, Executive Vice President of Regulatory Affairs and Quality Assurance

Before we begin, I would like to remind all listeners that throughout this call, we may

make statements that constitute forward-looking statements within the meaning of the

Private Securities Litigation Reform Act of 1995. Investors are cautioned that any

such forward-looking statements are not guarantees of future performance or the

successful execution of the company’s strategic plan and involve risks and


Actual results may differ materially from those forward-looking statements as a result

of various factors. Important factors that could cause actual results to differ materially

from those in the forward-looking statements are described in the company’s filings

with the Securities and Exchange Commission. I’d also like to note that any financials

discussed are based on unaudited results.

Dr. Kogan will open this morning’s call with a few operational highlights and hand the

call to Mr. Lyons to review the quarterly results. Dr. Hards will then provide an overview of progress with our development program, and hand the call back to Dr. Kogan for closing remarks and questions.

At this time, I’d like to turn the call over to Dr. Yakov Kogan, Chief Executive Officer. Please go ahead.

Yakov Kogan

Thank you, Rachel, and thank you to everyone for joining us for our Second Quarter 2012

Investor conference call. Before we get in to the details of the quarterly financials and the duration, I would like to update everyone on our progress with the FDA and federal funded agency.

As we discussed in our last call and at our June Investor Day, we had several meetings and communications with the federal funded agencies during the past few months. Including our two active constructive partners, that’s the Department of Defense and BARDA.

The purpose of this meeting was to ensure that the agency were up to speed on our most-recent FDA communications, especially conducting operations for our final [inaudible] animal and human safety study.

We also wanted the agency to have every opportunity to make their own inquest about our progress to date. All the meetings were already well attended by their appropriate ranking officials and achieved their respective goals.

We believe what we have done and continue to do everything we can to move forward with FDA and funded agencies, to complete 542 development as our [inaudible] counter measure in the most expedited manner.

I’m extremely proud of our large GUB efficacy study on CBLB502 and non-human primates, and the results of the recently-published biomarker study.

Andrei will review the details of this achievement later in the call, but I cannot think of two better examples over depth of our scientific understanding of 542. We will continue to keep all of the funding agencies informed of our progress with the FDA.

Our next step is to conduct a face-to-face meeting with the FDA in the coming weeks, and completion of additional requested data and protocols. We believe what – as we keep demonstrating forward movements with the FDA, funding agents will continue to support us.

I will leave it to our team to go for specific developments for our programs. However, I would like to highlight two key items. First, enrollment for Phase 1 CBLB502 trial, in advanced cancer patients, continues to progress in line with our expectations. I am pleased to say that those patients in the first two cohorts have been completed. And there have been no serious adverse events reported to date.

And second, we recently secured funding in non-dilutive funding for our 612 program for a contract with Russian industry and trade. This funding enable us to support completion of the clinical studies, finding over IND, and performance of Phase 1 and II clinical studies.

Now I will turn the call over to Neil, to go through the quarterly results.

C. Neil Lyons

Thank you, Yakov. Before I start reviewing details for the quarter, please note that all figures quoted in my talk this morning are approximate in value, and are based on unaudited results. Our unaudited financial statements for the quarter will be filed on Form 10-Q with the SEC shortly.

We ended the quarter with consulted cash, cash equivalence and short-term investment of 22 million. This amount includes a milestone payment of 6 million from Bioprocess Capital, our partner in Incuron.

In addition, Incuron’s research activities continue to qualify it under the scope of the grant, which has about 4 million still available. A recently announced CBLB612 contract is also valued at approximately 4 million on a pro forma basis, assuming the receipt of the full amount of each grant.

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