BUFFALO, NY--(Marketwired - May 16, 2016) - Cleveland BioLabs, Inc. (
Cleveland BioLabs reported a net loss, excluding minority interests, of $(0.7) million for the first quarter of 2016, or $(0.06) per share, compared to a net loss of $(3.7) million, or $(1.14) per share, for the first quarter of 2015.
As of March 31, 2016, the Company had $18.0 million in cash, cash equivalents and short-term investments, which, based on the Company's current operational plan, is expected to fund the Company's operating requirements beyond one year.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of commercialization for entolimod as a medical radiation countermeasure is our top priority. We are working with the U.S. Food and Drug Administration (FDA) to confirm the design of a bio-comparability study requested by the Agency during the review of our pre-EUA dossier. Our goals are to satisfy the FDA's request and facilitate continued regulatory review of the pre-EUA dossier for entolimod as soon as possible. In the meantime, we are moving forward with a regulatory process with the European Medicines Agency, which has granted entolimod orphan drug designation for the treatment of acute radiation syndrome."
"Clinical oncology studies with entolimod, CBLB612 and Mobilan are progressing in the Russian Federation," added Dr. Kogan. "The Phase 2 study of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer has recruited over 30 patients to date. Recruitment was completed in a Phase 2 study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy. The database for this study is being prepared for analysis. And finally, Panacela Labs continues dosing in a Phase 1 study with Mobilan evaluating single injections administered directly into the prostate of patients with prostate cancer. All of these studies are supported by development contracts with the Russian Federation Ministry of Industry and Trade."
Further Financial Results
Revenue for the first quarter of 2016 increased to $0.8 million compared to $0.6 million for the first quarter of 2015. This increase was primarily attributable to work performed under contracts from the Department of Defense for the continued development of the entolimod biodefense indication.
Research and development costs for the first quarter of 2016 increased to $1.9 million compared to $1.6 million for the first quarter of 2015. This increase was primarily attributable to Phase 2 oncology studies for entolimod and CBLB612 that were not active in 2015.
General and administrative costs for the first quarter of 2016 decreased to $1.2 million compared to $2.3 million for the first quarter of 2015. This decrease was primarily attributable to reductions in personnel and outside professional costs.
As of March 31, 2016 the Company had approximately 11 million shares of common stock outstanding. In addition, the Company has 336,942 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $46.05 and 2.2 million shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $13.98.
About Cleveland BioLabs
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, oncology immunotherapy, and vaccines. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 do not relate strictly to historical or current facts. Words and phrases such as "potential," "may," "future," "will," "plan," "anticipate," "believe," "intend" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the company's future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals or the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations. 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 risks inherent in the early stages of drug development and in conducting clinical trials; the company's plans and expectations with respect to future clinical trials and commercial scale-up activities; the company's ability to attract collaborators with development, regulatory and commercialization expertise and the financial risks related to those relationships; the company's ability to comply with its obligations under license agreements; the company's inability to obtain regulatory approval in a timely manner or at all; the commercialization of the company's product candidates, if approved; the company's plans to research, develop and commercialize its product candidates; future agreements with third parties in connection with the commercialization of any approved product; the size and growth potential of the markets for the company's product candidates, and its ability to serve those markets; the rate and degree of market acceptance of the company's product candidates; 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; regulatory developments in the United States and foreign countries; the performance of the company's third-party suppliers and manufacturers; and the success of competing therapies that are or may become available. 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.
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||10,594,828||$||5,918,424|
|Other current assets||500,108||442,642|
|Other long-term assets||26,581||26,560|
|LIABILITIES & STOCKHOLDERS' EQUITY|
|Accrued warrant liability||2,636,187||4,048,900|
|Commitments and contingencies||-||-|
|Total Cleveland BioLabs, Inc. stockholders' equity/(deficit)||9,771,855||9,888,182|
|Noncontrolling interest in stockholders' equity||5,176,752||5,149,670|
|Total stockholders' equity||14,948,607||15,037,852|
|Total liabilities and stockholders' equity||$||19,803,232||$||20,880,604|
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Quarter ended March 31,|
|Grants and contracts||$||812,500||$||607,329|
|Research and development||1,941,240||1,610,970|
|General and administrative||1,183,566||2,307,871|
|Total operating expenses||3,124,806||3,918,841|
|Loss from operations||(2,312,306||)||(3,311,512||)|
|Other income (expense):|
|Interest and other income (expense)||181,765||(46,394||)|
|Foreign exchange gain (loss)||47,086||(43,735||)|
|Change in value of warrant liability||1,412,713||(49,358||)|
|Equity in loss of Incuron, LLC||-||(247,566||)|
|Total other income (expense)||1,641,564||(387,053||)|
|Net loss attributable to Cleveland BioLabs, Inc.||(670,742||)||(3,698,565||)|
|Net loss attributable to noncontrolling interests||2,806||48,243|
|Net loss attributable to Cleveland BioLabs, Inc.||$||(667,936||)||$||(3,650,322||)|
|Net loss per share, basic and diluted||$||(0.06||)||$||(1.14||)|
|Weighted average number of shares, basic and diluted||10,987,166||3,206,249|
|CLEVELAND BIOLABS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
|For the Three Months Ended March 31,|
|Cash flows used in operating activities||$||(2,256,743||)||$||(2,227,550||)|
|Cash flows provided by investing activities||6,350,389||43,192|
|Cash flows provided by financing activities||539,998||3,311,877|
|Effect of exchange rate change on cash and equivalents||42,760||24,528|
|Increase in cash and cash equivalents||4,676,404||1,152,047|
|Cash and cash equivalents at beginning of period||5,918,424||3,103,969|
|Cash and cash equivalents at end of period||$||10,594,828||$||4,256,016|