UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): May 7, 2013
Cleveland BioLabs, Inc.
(Exact Name of Issuer as Specified in Charter)
DELAWARE |
001-32954 |
20-0077155 |
| (State or Other Jurisdiction of Incorporation or Organization) |
(Commission File Number) | (I.R.S. Employer Identification Number) |
73 High Street Buffalo, NY |
14203 |
| (Address of Principal Executive Offices) | (Zip Code) |
(716) 849-6810
(Registrant's Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: |
|
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On May 9, 2013, Cleveland BioLabs, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended March 31, 2013. The information in this Item 2.02 of Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On May 7, 2013, the Board of Directors (the "Board") of the Company expanded the size of the Board from nine to ten members and elected Randy S. Saluck as a director of the Company to hold such office until the Company's 2013 Annual Meeting of Stockholders.
Mr. Saluck has been the Managing Member of Mortar Rock Capital Management, LLC and the Portfolio Manager of Mortar Rock Capital LP, a value-oriented investment fund, since 2005. From 2002 to 2005, Mr. Saluck was a portfolio manager at the investment fund of Meisenbach Capital, LP and, from 2000 to 2002, Mr. Saluck was a senior analyst at Tyndall Partners, LLC, which invested in value-oriented equities and distressed debt. From 1999 to 2000, Mr. Saluck was an analyst at Highfields Capital Management, LLC, where he was responsible for special situations and risk arbitrage. Prior thereto, Mr. Saluck was an investment banker focused on mergers and acquisitions involving a variety of industries at Salomon Brothers Inc. Before becoming an investment banker, Mr. Saluck was a corporate and securities attorney, working at Cahill Gordon & Reindel LLP and then Tenzer Greenblatt LLP. As an attorney, Mr. Saluck worked with numerous small capitalization companies assisting them in the execution of their financing and strategic plans. He received a Bachelor's degree from the University of Pennsylvania, a Juris Doctor degree from the University of Virginia and an MBA from the Wharton School of the University of Pennsylvania with a concentration in finance and accounting. Mr. Saluck currently serves on the Board of Directors of the Connecticut Region of the Anti-Defamation League.
In connection with his appointment to the Board, Mr. Saluck was granted an option to purchase 15,000 shares of the Company's common stock. The options will vest in three equal installments on the first, second and third anniversaries of Mr. Saluck's appointment to the Board and will accelerate in full upon a change in control of the Company or upon his death, disability or retirement.
There are no transactions between Mr. Saluck and the Company required to be reported pursuant to Item 404(a) of Regulation S-K.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibit No.
Description
99.1
Press Release dated May 9, 2013
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Cleveland BioLabs, Inc. |
||
| Date: May 9, 2013 | By: /s/ YAKOV KOGAN Name: Yakov Kogan, Ph.D., M.B.A. Title: Chief Executive Officer |
EXHIBIT 99.1
BUFFALO, N.Y., May 9, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today reported financial results and development progress for the first quarter ended March 31, 2013.
Cleveland BioLabs reported a net loss attributable to its common stockholders for the first quarter of 2013 of $9.8 million, or $0.22 per share of common stock, as compared to a net loss attributable to its common stockholders of $5.4 million, or $0.15 per share of common stock, for the first quarter of 2012.
At March 31, 2013, the Company had $21.1 million in cash, cash equivalents and short-term investments, $13.4 million of which was available for general use and $7.7 million of which was restricted for the use of majority-owned subsidiaries.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "We recently took some significant steps forward in aligning our organization to support our evolution into a more clinically-oriented company. We announced the addition of three new directors to our board. Julia Brown and Anthony Principi, J.D. both have long histories of leadership roles in the pharmaceutical industry, and in Anthony's case, the Federal government, as well. We believe their first-hand experience and understanding of the challenges we face as a young drug development company and a government contractor will help us better navigate the road ahead. Randy Saluck, J.D., MBA has been a shareholder of CBLI since 2009 and adds the perspective of more than 20 years of fund management and investment banking on Wall Street.
"In addition, we have intensified our focus on regulatory affairs and clinical development, which was reflected by our addition of Jean Viallet, M.D. as Chief Development Officer, along with Gillian Miller, Ph.D., as Senior Director of Regulatory Affairs and Judith Schnyder, MBA as Director of Clinical Operations. We believe these enhancements to our operational leadership will be invaluable as we advance our oncology clinical trials and pursue approval of Entolimod as a radiation countermeasure."
Operational Highlights
Enrollment of the Entolimod advanced cancer trial at Roswell Park Cancer Institute continues. To date, no serious adverse events have been reported.
The Company recently announced publication of studies identifying the liver as a key mediator of Entolimod's tissue-protective and anticancer activities in Proceedings of the National Academy of Sciences of the United States of America (PNAS), the official journal of the United States National Academy of Sciences. These studies provide new mechanistic insight into the radioprotection, radiomitigation and anticancer activities of Entolimod, strengthening the understanding of the drug's ability to mitigate radiation damage to the hematopoietic system and the hypothesis behind the ongoing clinical study in advanced cancer patients at Roswell Park Cancer Institute. The previously unanticipated effects of Entolimod on hepatocytes and the liver microenvironment defined in this work suggest that prevention or treatment of liver metastases and protection of the liver from various types of cell stress are additional areas of prospective clinical application for Entolimod.
Incuron, LLC, one of Cleveland BioLabs' majority-owned subsidiaries, is dosing the third cohort in a Phase 1, single agent, dose escalation study of the oral formulation of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment in the Russian Federation. An Investigational New Drug application for a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers has been allowed by the U.S. Food and Drug Administration and the protocol is being finalized.
The final cohort of the dose escalation arm in Incuron's ongoing Phase 1 single-dose ascending trial of CBL0102 in advanced cancer patients with liver metastases has been completed, reaching at least the equivalent efficacious dose reached in preclinical studies. Pending a decision from the review board, it may be decided that this trial has achieved its goals with regard to safety and may be concluded. An investigator-initiated trial with CBL0102 in combination with Erlotinib in patients with advanced non-small-cell lung cancer is being prepared with plans to open it for patient accrual at the Case Comprehensive Cancer Center and the Cleveland Clinic.
Further Financial Highlights
Revenue for the first quarter ended March 31, 2013 increased to $1.4 million compared to $0.9 million for the prior year's period, primarily due to increases in funding from the Russian Federation's Ministry of Industry and Trade and Skolkovo Foundation.
Research and development expense for the first quarter was $5.3 million compared to $6.0 million for the same period in 2012. This decrease was primarily due to the efforts to complete a pivotal non-human primate study during the first quarter of 2012.
General and Administrative expense for the first quarter was $3.5 million compared to $2.4 million for the first quarter of 2012. This increase was primarily attributable to increases in general and administrative functions at our subsidiaries and business development expenditures, among other items.
As of December 31, 2012, Cleveland BioLabs had approximately 44.9 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 May 9, 2013, at 1:00 p.m. ET through May 23, 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 413582. 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 ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; financial projections and estimates and their underlying assumptions; 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.
Contact:
Rachel Levine, Vice President, Investor Relations
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com
TABLES FOLLOW
| CLEVELAND BIOLABS, INC. AND SUBSIDIARIES | ||
| CONSOLIDATED BALANCE SEEETS | ||
| March 31, | December 31, | |
| 2012 | 2011 | |
| (unaudited) | ||
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 19,769,013 | $ 25,652,083 |
| Short-term investments | 1,286,861 | 2,633,944 |
| Accounts receivable | 477,180 | 41,896 |
| Other current assets | 1,136,042 | 1,078,040 |
| Total current assets | 22,669,096 | 29,405,963 |
| Equipment, net | 910,897 | 986,553 |
| Restricted cash | 1,541,842 | 1,577,920 |
| Other long-term assets | 61,592 | 39,597 |
| Total assets | $ 25,183,427 | $ 32,010,033 |
| LIABILITIES & STOCKHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 1,234,575 | $ 1,523,875 |
| Accrued expenses | 3,285,022 | 2,410,592 |
| Deferred revenue | 3,024,565 | 3,314,918 |
| Accrued warrant liability | 7,553,382 | 4,105,659 |
| Current portion of capital lease obligation | 74,276 | 71,679 |
| Total current liabilities | 15,171,820 | 11,426,723 |
| Noncurrent portion of capital lease obligation | 78,030 | 97,602 |
| Commitments and contingencies | -- | -- |
| Total liabilities | 15,249,850 | 11,524,325 |
| Stockholders' equity: | ||
| Total Cleveland BioLabs, Inc. stockholders' equity (deficit) | (3,130,884) | 6,333,167 |
| Noncontrolling interest in stockholders' equity | 13,064,461 | 14,152,541 |
| Total stockholders' equity | 9,933,577 | 20,485,708 |
| Total liabilities and stockholders' equity | $ 25,183,427 | $ 32,010,033 |
| CLEVELAND BIOLABS, INC. AND SUBSIDIARIES | ||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||
| (UNAUDITED) | ||
| Quarter Ended March 31, | ||
| 2013 | 2012 | |
| Revenues: | ||
| Grants and contracts | $ 1,367,472 | $ 931,397 |
| Operating expenses: | ||
| Research and development | 5,331,615 | 5,985,801 |
| General and administrative | 3,483,372 | 2,427,471 |
| Total operating expenses | 8,814,987 | 8,413,272 |
| Loss from operations | (7,447,515) | (7,481,875) |
| Other income (expense): | ||
| Interest and other income | 79,956 | 55,641 |
| Foreign exchange gain (loss) | 28,134 | (692,416) |
| Change in value of warrant liability | (3,447,723) | 1,719,756 |
| Total other income (expense) | (3,339,633) | 1,082,981 |
| Net loss | (10,787,148) | (6,398,894) |
| Net loss attributable to noncontrolling interests | 1,022,825 | 1,011,748 |
| Net loss attributable to Cleveland BioLabs, Inc. | $ (9,764,323) | $ (5,387,146) |
| Net loss available to common stockholders per share of common stock, basic and diluted | $ (0.22) | $ (0.15) |
| Weighted average number of shares used in calculating net loss per share, basic and diluted | 44,826,576 | 35,657,563 |
| CLEVELAND BIOLABS, INC. AND SUBSIDIARIES | ||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
| (UNAUDITED) | ||
| Quarter Ended March 31, | ||
| 2013 | 2012 | |
| Cash flows used in operating activities | $ (7,003,302) | $ (4,794,372) |
| Cash flows provided by (used in) investing activities | 1,295,121 | (81,560) |
| Cash flows provided by financing activities | (16,974) | (3,541) |
| Effect of exchange rate change on cash and equivalents | (157,915) | 118,371 |
| Increase in cash and cash equivalents | (5,883,070) | (4,761,102) |
| Cash and cash equivalents at beginning of period | 25,652,083 | 22,872,589 |
| Cash and cash equivalents at end of period | $ 19,769,013 | $ 18,111,487 |