BUFFALO, N.Y., Aug. 13, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today reported financial results and development progress for the second quarter and six-month periods ended June 30, 2013.
Cleveland BioLabs reported a net loss attributable to its common stockholders for the second quarter of 2013 of $3.0 million, or $0.07 per share of common stock, as compared to a net loss attributable to its common stockholders of $5.1 million, or $0.14 per share of common stock, for the second quarter of 2012. Cleveland BioLabs reported a net loss attributable to its common stockholders for the first six months of 2013 of $12.8 million, or $0.29 per share of common stock, as compared to a net loss attributable to its common stockholders of $10.5 million, or $0.29 per share of common stock, for the same period in 2012.
At June 30, 2013, the Company had $13.6 million in cash, cash equivalents and short-term investments, $8.8 million of which was available for general use and $4.8 million of which was restricted for the use of majority-owned subsidiaries.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "We remain focused on advancing our pipeline. We continue to execute studies under our ongoing Department of Defense contracts for the Entolimod radiation countermeasure program, while we await definitive feedback on our development proposal to the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services. We are actively engaged with the U.S. Food and Drug Administration and are making steady progress towards finalizing remaining requirements for a Biologics License Application and pre-Emergency Use Authorization submission for this indication."
"Our development team is also moving forward with oncology studies," added Dr. Kogan. "We recently announced treatment of the first patient in a multi-center, Phase 1 trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas in the U.S. We are very excited to have this study underway and to further explore our findings related to Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137."
The "in-life" portion of the only required non-irradiated non-human primate study with Entolimod for the radiation countermeasure indication was completed during the quarter. This study is supported by the Company's contract with the Chemical Biological Medical Systems division of the Department of Defense.
The Entolimod advanced cancer trial at Roswell Park Cancer Institute is being amended to further optimize the dosing regimen based on initial observations.
During the quarter, Incuron, LLC, one of CBLI's majority-owned subsidiaries, announced the publication of studies describing FACT, the molecular target of CBL0137, as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports. The published work concluded that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation. Further studies are underway to determine if this biomarker can serve as a companion diagnostic to screen patients for CBL0137 treatment.
In parallel to the U.S. trial with CBL0137, Incuron continues to enroll patients in the fourth cohort of an ongoing Phase 1 study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment in the Russian Federation. To date, no drug-related serious adverse events have been reported in this trial.
The Review Board for Incuron's Phase 1 trial of CBL0102 in advanced cancer patients with liver metastases in the Russian Federation decided that this trial has achieved its goals with regard to safety and that the database may be prepared for analysis. This trial is expected to report in the fourth quarter of 2013.
An Investigational New Drug application for CBLB612, a drug in development for the induction and mobilization of hematopoietic stem cells, was recently filed with the regulatory authorities in the Russian Federation. Development of CBLB612 is currently funded by a contract from the Ministry of Industry and Trade of the Russian Federation, awarded in July 2012.
Further Financial Highlights
Revenue for the second quarter of 2013 increased to $1.6 million compared to $0.3 million for the prior year's second quarter. Revenue for the first six months of 2013 increased to $3.0 million compared to $1.2 million for the same period in 2012. For both periods, the increased revenue was primarily due to increases in contract and grant funding from the Russian Federation's Ministry of Industry and Trade, Skolkovo Foundation and the U.S. Department of Defense.
Research and development costs for the second quarter of 2013 decreased to $5.4 million compared to $6.1 million for the same period in 2012. Research and development costs for the first six months of 2013 decreased to $10.7 million in 2013 compared to $12.1 million for the same 2012 period. These decreases were primarily due to the efforts to complete a pivotal non-human primate study during 2012 and a decrease in the pace of development of preclinical assets at Panacela Labs.
General and administrative costs for the second quarter of 2013 decreased 9% to $3.0 million compared to $3.3 million for the three months ended June 30, 2012. General and administrative costs for the first six months of 2013 increased 13% to $6.5 million from $5.8 million for the six months ended June 30, 2012. This increase was primarily attributable to increases of $0.4 million for our Russian-based subsidiaries including BioLabs 612 which was not operational in 2012 and $0.3 million in corporate legal and intellectual property fees.
As of June 30, 2013, Cleveland BioLabs had approximately 45 million shares of common stock outstanding.
Conference Call Information
Management will host a conference call at 10:00 a.m. ET today to provide updates and address investor questions regarding general business developments. Interested parties may participate by dialing 877-407-8031 (US) or 201-689-8031 (International), approximately five to ten minutes before the call start time. A live webcast of the conference call will be available on the investor page of the Cleveland BioLabs web site at www.cbiolabs.com. A replay of the call will be available starting on August 13, 2013, at 1:00 p.m. ET through August 28, 2013, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering conference ID number 418722. An archived webcast of the conference call will be available on the investor page of the Cleveland BioLabs web site at www.cbiolabs.com.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging a deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our regulatory submissions and discussions with regulators, our ability to successfully develop and commercialize our therapeutic products; the conduct and results of our various clinical trials; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These factors include, among others, the Company's failure to successfully and timely develop new products; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.
Rachel Levine, Vice President, Investor Relations
Cleveland BioLabs, Inc.
T: (646) 284-9439
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED BALANCE SEEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$ 13,245,397||$ 25,652,083|
|Other current assets||730,074||1,078,040|
|Total current assets||15,453,641||29,405,963|
|Other long-term assets||54,033||39,597|
|Total assets||$ 17,853,214||$ 32,010,033|
|LIABILITIES & STOCKHOLDERS' EQUITY|
|Accounts payable||$ 1,194,219||$ 1,523,875|
|Accrued warrant liability||4,757,770||4,105,659|
|Current portion of capital lease obligation||77,886||71,679|
|Noncurrent portion of capital lease obligation||50,827||97,602|
|Commitments and contingencies||--||--|
|Total Cleveland BioLabs, Inc. stockholders' equity (deficit)||(5,802,824)||6,333,167|
|Noncontrolling interest in stockholders' equity||12,103,343||14,152,541|
|Total stockholders' equity||6,300,519||20,485,708|
|Total liabilities and stockholders' equity||$ 17,853,214||$ 32,010,033|
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Quarter Ended June 30,||Year to Date June 30,|
|Grants and contracts||$ 1,613,262||$ 258,237||$ 2,980,734||$ 1,189,634|
|Research and development||5,373,029||6,093,275||10,704,644||12,079,076|
|General and administrative||3,016,851||3,326,686||6,500,223||5,754,157|
|Total operating expenses||8,389,880||9,419,961||17,204,867||17,833,233|
|Loss from operations||(6,776,618)||(9,161,724)||(14,224,133)||(16,643,599)|
|Other income (expense):|
|Interest and other income||47,809||70,252||127,765||125,893|
|Foreign exchange gain (loss)||46,776||641,332||74,910||(51,084)|
|Change in value of warrant liability||2,795,612||2,543,270||(652,111)||4,263,026|
|Total other income (expense)||2,890,197||3,254,854||(449,436)||4,337,835|
|Net loss attributable to noncontrolling interests||844,310||828,186||1,867,135||1,839,934|
|Net loss attributable to Cleveland BioLabs, Inc.||$ (3,042,111)||$ (5,078,684)||$ (12,806,434)||$ (10,465,830)|
|Net loss available to common stockholders per share of common stock, basic and diluted||$ (0.07)||$ (0.14)||$ (0.29)||$ (0.29)|
|Weighted average number of shares used in calculating net loss per share, basic and diluted||44,948,591||35,745,675||44,887,920||35,701,619|
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
|For the Six Months Ended June 30,|
|Cash flows used in operating activities||$ (14,123,795)||$ (12,169,517)|
|Cash flows provided by (used in) investing activities||2,171,034||(3,742,698)|
|Cash flows provided by (used in) financing activities||(28,176)||5,874,761|
|Effect of exchange rate change on cash and equivalents||(425,749)||394,545|
|Increase in cash and cash equivalents||(12,406,686)||(9,642,909)|
|Cash and cash equivalents at beginning of period||25,652,083||22,872,589|
|Cash and cash equivalents at end of period||$ 13,245,397||$ 13,229,680|