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Exhibit 99.1

 

LOGO

 

 

FOR IMMEDIATE RELEASE

CLEVELAND BIOLABS REPORTS THIRD QUARTER 2014 FINANCIAL

RESULTS AND DEVELOPMENT PROGRESS

Buffalo, NY — November 5, 2014 – Cleveland BioLabs, Inc. (NASDAQ:CBLI) today reported financial results and development progress for the third quarter ended September 30, 2014.

Cleveland BioLabs reported a net loss for the third quarter of 2014 of $4.1 million, or $0.07 per share, compared to a net loss of $4.1 million, or $0.09 per share, for the same period in 2013. Net loss for the first nine months of 2014 was $9.6 million, or $0.18 per share, compared to a net loss of $16.9 million, or $0.38 per share, for the same period in 2013, a reduction of $7.3 million. This net loss reduction was due to a reduction in operating losses of $9.1 million, and $1.2 million of non-cash income related to a change in value of accrued warrant liability, offset by $1.2 million for additional interest expense, $0.4 million in foreign exchange losses and $1.4 million in losses attributed to minority interests. The reduced operating losses were due to a narrowed focus of development activities, lower development costs for entolimod’s biodefense indication and other cost saving measures.

At September 30, 2014, the Company had cash, cash equivalents and short-term investments of $9.1 million, $4.9 million of which was available for general use and $4.2 million of which was restricted for the use of subsidiaries.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, “We achieved several milestones during the third quarter. Agreement was reached with the U.S. Food and Drug Administration that our existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-Emergency Use Authorization (pre-EUA) submission for entolimod’s biodefense indication. Our team has been focused on compiling an application that has the highest chances for success as quickly as possible. On the oncology side of our business, the Phase 1 study of entolimod in patients with advanced cancer at Roswell Park Cancer Institute has been concluded. Analysis of trial data, including immune cell response, is expected to be complete in the first half of 2015. We are preparing a small expansion study in the Russian Federation to gather additional immune cell response data at the highest dose levels reached in the Roswell Park study. This expansion study will be financially supported by a matching-funds grant from the Russian Ministry of Industry and Trade. We are also finalizing interim data for the oral administration study of Curaxin CBL0137. Lastly, dosing was started in a Phase 1 healthy subject study of CBLB612, a drug candidate in development for the induction and mobilization of hematopoietic stem cells (HSCs). 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.”

Recruitment of the sixth cohort is underway in a multi-center, Phase 1 trial assessing the intravenous administration of Curaxin CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas. In parallel, dosing of the eighth cohort is ongoing in a multicenter, Phase 1 study assessing the oral administration of Curaxin CBL0137 in patients with advanced solid tumors that are resistant or refractory to current standard treatment. To date, no drug-related serious adverse events


have been reported in either trial.

Further Financial Highlights

Revenue for the third quarter of 2014 decreased to $0.4 million compared to $1.6 million for the third quarter of 2013. Revenue for the first nine months of 2014 decreased to $2.3 million compared to $4.6 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 the Ministry of Industry and Trade of the Russian Federation, or MPT.

Research and development costs for the third quarter of 2014 decreased to $2.1 million compared to $4.2 million for the same period in 2013. Nine-month research and development costs for the 2014 period decreased to $6.8 million compared to $14.9 million for the same period in 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 primarily attributable to our transfer of personnel to Buffalo BioLabs, LLC in the fourth quarter of 2013.

General and administrative costs for the third quarter of 2014 decreased to $1.8 million compared to $3.3 million for the same period in 2013. General and administrative costs for the first nine months of 2014 decreased to $6.5 million compared to $9.8 million for the same period in 2013. For the nine-month period, $2.0 million of these decreases were due to reduction in costs related to our personnel and consultants and $1.3 million were due to other cost-saving actions.

Conference Call Information

Cleveland BioLabs 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 877-407-9205 (US) or 201-689-8054 (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 November 5, 2014, at 1:00 p.m. ET through November 19, 2014, 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 13593933. An archived webcast of the conference call will be available for 90 days on the Investors page of the Cleveland BioLabs web site at www.cbiolabs.com.

About Cleveland BioLabs

Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company’s lead product candidates are entolimod, which is being developed for a biodefense indication and as a potential cancer treatment, and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children’s Cancer Institute Australia. 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

 

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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,” “preparing,” “finalizing,” and “underway” 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 successfully submit and receive approval of our pre-EUA application for entolimod, the conduct and results of our various clinical trials; our ability to obtain approval from the U.S. Food and Drug Administration of our product candidates; our ability to successfully submit and receive approval of our pre-EUA application for entolimod; 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 risks and uncertainties include, among others, the Company’s failure to successfully and timely develop existing and new products; the Company’s collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials; 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; subsequent changes in the agreement with the Russian Ministry of Industry and Trade, 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. 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: (917) 375-2935

E: rlevine@cbiolabs.com

 

TABLES FOLLOW

 

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CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

     September 30,
2014
    December 31,
2013
 
     (unaudited)        
ASSETS   

Current assets:

    

Cash and cash equivalents

   $ 7,877,432      $ 10,048,466   

Short-term investments

     1,269,467        305,538   

Accounts receivable

     175,191        458,391   

Other current assets

     365,461        344,386   
  

 

 

   

 

 

 

Total current assets

     9,687,551        11,156,781   

Equipment, net

     287,827        457,912   

Restricted cash

     2,427,874        2,921,724   

Other long-term assets

     65,192        159,224   
  

 

 

   

 

 

 

Total assets

   $ 12,468,444      $ 14,695,641   
  

 

 

   

 

 

 
LIABILITIES & STOCKHOLDERS' EQUITY   

Current liabilities:

    

Accounts payable

   $ 889,402      $ 794,397   

Accrued expenses

     1,796,382        2,445,446   

Deferred revenue

     356,580        1,069,438   

Accrued warrant liability

     1,861,013        1,241,311   

Current portion of note payable

     735,654        351,527   

Current portion of capital lease obligation

     29,560        83,634   
  

 

 

   

 

 

 
     5,668,591        5,985,753   

Noncurrent portion of capital lease obligation

     —          7,522   

Long-term debt

     3,479,396        7,121,388   

Commitments and contingencies

     —          —     
  

 

 

   

 

 

 

Total liabilities

     9,147,987        13,114,663   

Stockholders' equity:

    

Total Cleveland BioLabs, Inc. stockholders' deficit

     (10,349,558     (9,522,945

Noncontrolling interest in stockholders' equity

     13,670,015        11,103,923   
  

 

 

   

 

 

 

Total stockholders' equity

     3,320,457        1,580,978   
  

 

 

   

 

 

 

Total liabilities and stockholders' equity

   $ 12,468,444      $ 14,695,641   
  

 

 

   

 

 

 

 

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CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

     Quarter Ended September 30,     Nine months ended September 30,  
     2014     2013     2014     2013  

Revenues:

        

Grants and contracts

   $ 415,126      $ 1,635,600      $ 2,311,467      $ 4,616,334   

Operating expenses:

        

Research and development

     2,068,245        4,205,238        6,832,241        14,909,882   

General and administrative

     1,785,620        3,286,830        6,449,531        9,787,053   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     3,853,865        7,492,068        13,281,772        24,696,935   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (3,438,739     (5,856,468     (10,970,305     (20,080,601
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Interest and other income (expense)

     (68,932     97,534        (1,010,640     225,299   

Foreign exchange gain (loss)

     (271,699     (15,057     (330,876     59,853   

Change in value of warrant liability

     (836,293     1,163,030        1,663,390        510,919   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     (1,176,924     1,245,507        321,874        796,071   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (4,615,663     (4,610,961     (10,648,431     (19,284,530
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to noncontrolling interests

     519,529        519,765        1,005,764        2,386,900   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to Cleveland BioLabs, Inc.

   $ (4,096,134   $ (4,091,196   $ (9,642,667   $ (16,897,630
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss available to common stockholders per share of common stock, basic and diluted

   $ (0.07   $ (0.09   $ (0.18   $ (0.38
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of shares used in calculating net loss per share, basic and diluted

     57,110,198        45,061,274        53,016,147        44,946,340   

 

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CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

     Nine Months Ended
September 30,
 
     2014     2013  

Cash flows used in operating activities

   $ (11,316,565   $ (18,923,142

Cash flows provided by (used in) investing activities

     (1,142,661     666,920   

Cash flows provided by financing activities

     10,788,298        7,251,055   

Effect of exchange rate change on cash and equivalents

     (500,106     (333,995
  

 

 

   

 

 

 

Increase (decrease) in cash and cash equivalents

     (2,171,034     (11,339,162

Cash and cash equivalents at beginning of period

     10,048,466        25,652,083   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 7,877,432      $ 14,312,921   
  

 

 

   

 

 

 

 

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CLEVELAND BIOLABS, INC. AND SUBSIDIARIES

NON-GAAP FINANCIAL MEASURES

(UNAUDITED)

We define net cash burn as the net increase (or decrease) in cash, cash equivalents and short-term investments excluding the effect of capital markets financing activities, and the net increase (or decrease) in restricted cash, as determined in accordance with generally accepted accounting principles or GAAP. And we separately track net cash burn for Cleveland BioLabs, Inc. and its wholly-owned subsidiary BioLab 612, LLC, which we refer to as CBLI Stand-alone, as well as for the consolidated entity which includes the accounts of Incuron, LLC, Panacela Labs, Inc. and Panacela Labs, LLC. This non-GAAP measure may be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. We believe that net cash burn is relevant and useful information for the Company and our investors as it provides a simple method of determining net cash used by the Company. A calculation of net cash burn is provided below:

 

     Quarter Ended September 30,     Nine months ended September 30,  
     2014     2013     2014     2013  

CBLI Stand-alone:

        

Cash, cash equivalents, and short-term investments, beginning of period

   $ 7,654,233      $ 8,789,689      $ 7,957,302      $ 17,945,147   

Cash, cash equivalents and short-term investments, end of period

     4,881,603        10,831,221        4,881,603        10,831,221   
  

 

 

   

 

 

   

 

 

   

 

 

 

Period increase/(decrease)

     (2,772,630     2,041,532        (3,075,699     (7,113,926

Less net proceeds from the sale of common stock

     —          —          (9,697,501     —     

Plus/(minus) loan prepayments/(proceeds)

     —          (5,797,675     4,000,000        (5,797,675
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash burn for the period

     (2,772,630     (3,756,143     (8,773,200     (12,911,601

Number of months in period

     3        3        9        9   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net monthly cash burn

   $ (924,210   $ (1,252,048   $ (974,800   $ (1,434,622
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated:

        

Cash, cash equivalents, and short-term investments, beginning of period

   $ 11,103,596      $ 13,551,123      $ 10,354,004      $ 28,286,027   

Cash, cash equivalents and short-term investments, end of period

     9,146,899        14,622,087        9,146,899        14,622,087   
  

 

 

   

 

 

   

 

 

   

 

 

 

Period increase/(decrease)

     (1,956,697     1,070,964        (1,207,105     (13,663,940

Less net proceeds from the sale of common stock

     —          —          (9,697,501     —     

Plus/(minus) loan prepayments/(proceeds)

     —          (5,797,675     4,000,000        (7,297,675

Less noncontrolling interest capital contribution to Incuron, LLC

     (2,237,154     —          (5,152,393     —     

Investments in restricted cash

           1,421,861   

Net cash burn for the period

     (4,193,851     (4,726,711     (12,056,999     (19,539,754

Number of months in period

     3        3        9        9   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net monthly cash burn

   $ (1,397,950   $ (1,575,570   $ (1,339,667   $ (2,171,084
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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