Cleveland BioLabs Reports Fourth Quarter and Fiscal 2014 Financial Results and Development Progress

Cleveland BioLabs reported a net income for the fourth quarter of 2014 of $11.3 million, or $3.95 per share, compared to a net loss of $0.4 million, or $0.16 per share, for the same period in 2013.Net income for fiscal 2014 was $1.6 million, or $0.60 per share, compared to a net loss of $17.3 million, or $7.67 per share, for the same period in 2013.The increase in net income was primarily attributable to a $14.2 million gain on the deconsolidation of the Company's joint venture, Incuron LLC.Excluding the gain on the deconsolidation of Incuron, net loss per share for the fourth quarter of 2014 was $1.02 and net loss per share for fiscal 2014 was $4.66.

At December 31, 2014, the Company had cash, cash equivalents and short-term investments of $3.1 million, $0.5 million of which was restricted for the use of subsidiaries Panacela Labs, Inc. and BioLab 612, LLC.In addition, on February 6, 2015, the Company closed an equity transaction pursuant to which it received net proceeds of approximately $3.7 million.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "We have made significant progress with all of our development programs over the past few months and believe that 2015 will be an important year for CBLI, as we near potential commercialization for entolimod's biodefense indication and release clinical data bringing validation to our first-in-class oncology assets.The pre-Emergency Use Authorization (pre-EUA) submission for entolimod is on schedule to be filed within the first half of 2015.We are actively engaged with several U.S. government agencies to solicit their input to our pre-EUA dossier, as well as potential funding and procurement support.We recently announced that we received notice that our proposal to support further development of entolimod as a medical radiation countermeasure has been recommended for funding by the Department of Defense office of Congressionally Directed Medical Research Programs.This potential funding is subject to negotiations and availability of funds and relates to our proposal to conduct several pivotal animal efficacy studies required by the U.S. Food and Drug Administration(FDA) for submission of a Biological Licensure Application (BLA)."

"In addition, our oncology drug candidates continue to advance through clinical studies," continued Dr. Kogan."The Phase 1 study of entolimod in advanced cancer patients at Roswell Park Cancer Institute has been completed and the findings have been submitted for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO), which will be held from May 29 - June 2 in Chicago, Illinois.Preliminary evaluations of the study indicate that the tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers and initial assessments of immunological response were consistent with activation of toll-like receptor 5 (TLR5), the drug's target.Early analyses also indicate that stable disease was observed in several patients with heavily pretreated cancers.These observations confirm our preclinical findings and support the hypothesis that entolimod has potential as an immunotherapeutic agent.We have initiated a follow-on study in Moscow, Russia intended to extend the clinical observations from the higher entolimod dose levels evaluated in the Roswell Park trial.This follow-on study is supported by a matching-funds development contract from the Ministry of Industry and Trade of the Russian Federation (MPT)."

"Incuron's two ongoing clinical studies evaluating oral and intravenous administrations of Curaxin CBL0137 in patients with advanced solid tumors are recruiting patients to the ninth and seventh dose-escalation cohorts, respectively.In January, we disclosed that a formal interim analysis of the 19 patients enrolled in the first six cohorts of the ongoing oral administration study indicated that the study medication was well tolerated at all investigated dose levels.The observation of drug exposure in plasma documented high oral bioavailability (typically estimated to be greater than or equal to 50%).To date, no dose-limiting toxicities have been observed with either oral or intravenous administration through the highest CBL0137 dose levels tested.Heavily pretreated patients with advanced cancers of the esophagus, colon, breast, cervix, and prostate have had stable disease for periods ranging from 4 to 6 months.Peripheral blood mononuclear cells (PBMC) from evaluable blood samples have shown pharmacodynamic effects consistent with the expected mechanism of action of CBL0137.These initial results are encouraging, and Incuron plans to initiate a multicenter study of CBL0137 in patients with hematological malignancies in 2015."

"Finally, the Phase 1 healthy subject study of CBLB612, a drug candidate in development for the induction and mobilization of hematopoietic stem cells (HSCs) continues.In addition to evaluating safety, tolerability and pharmacology of a single administration of CBLB612, this study has been designed to characterize the type, quantity and timing of HSC mobilization in these subjects.We look forward to sharing continued progress with our drug candidates as more clinical data becomes available."

Further Financial Highlights

Revenue for the fourth quarter of 2014 decreased to $1.4 million compared to $3.9 million for the fourth quarter of 2013.Revenue for fiscal 2014 decreased to $3.7 million compared to $8.5 million for the same period in 2013.These decreases were primarily the result of the completion of contracts with the Department of Defense for entolimod's biodefense indication and variances in the levels of development activity under other contracts with MPT.

Research and development costs for the fourth quarter of 2014 decreased to $2.8 million compared to $4.6 million for the same period in 2013.Research and development costs for fiscal 2014 decreased to $9.7 million compared to $19.5 million for the same period in fiscal 2013.These decreases were primarily due to completion of third-party service contracts for several compounds in-line with and largely in support of the contracted development work discussed above, as well as reduced compensation costs in-line with our reduced workforce.

General and administrative costs for the fourth quarter of 2014 decreased to $2.0 million compared to $2.3 million for the same period in 2013.General and administrative costs for fiscal 2014 decreased to $8.5 million compared to $12.0 million for the same period in 2013.For the year, $2.2 million of these decreases were due to reduction in personnel and consultants.

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Cleveland BioLabs Reports Fourth Quarter and Fiscal 2014 Financial Results and Development Progress