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| 8-K - 8-K - CONTRAFECT Corp | d166131d8k.htm |
Exhibit 99.1
ContraFect Announces First Quarter 2016 Results
YONKERS, New York — May 10, 2016 — ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announces results for the first quarter ended March 31, 2016.
In the last quarter, ContraFect made significant progress in advancing its first-in-class lysin product candidate CF-301 intended for the treatment of Staphylococcus aureus (Staph aureus) bloodstream infections including endocarditis. Details of the recently completed Phase 1 study were presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) and demonstrate that CF-301 was generally well-tolerated and there were no clinical adverse safety signals observed in the study. In this study, CF-301 had a predictable, dose-related, pharmacokinetic (PK) profile. Importantly, based on modeling of these human PK data and animal efficacy and exposure data, a 0.25 mg/kg dose is anticipated to be effective in treating patients with Staph aureus and has been selected for use in the upcoming Phase 2 study. “We are pleased to have completed our key analyses of the Phase 1 study of CF-301, which together with data from extensive animal studies, support a solid rationale for the advancement of CF-301 into Phase 2. We look forward to the Phase 2 study which we expect to initiate in the fourth quarter of 2016,” said Steven C. Gilman, PhD, Chairman and CEO of ContraFect.
The company presently anticipates the IND submission for the CF-404 program, a combination monoclonal antibody treatment for serious influenza, to occur in mid-2017 rather than 4Q16 due to a formulation adjustment.
First Quarter 2016 Financial Results:
| • | Research and development expenses were $4.4 million for the first quarter of 2016 compared to $2.4 million in the comparable period in 2015. The increase in research and development expenses was primarily due to the costs incurred in preparation for a Phase 2 clinical trial of CF-301, IND-enabling activities for CF-404, and the overall increase in our research and development headcount and related laboratory costs. |
| • | General and administrative expenses were $4.7 million for the first quarter of 2016 compared to $2.3 million in the comparable period in 2015. The increase in general and administrative expenses was primarily attributable to one time severance costs of $2.0 million, including $0.5 million of non-cash share-based compensation expense, the overall increase in our administrative headcount, and related personnel costs and increased legal and accounting costs related to SEC filings. |
| • | Net loss was $8.9 million, or $0.32 per share, for the first quarter of 2016 compared to a net loss of $4.9 million, or $0.24 per share, for the comparable periods in 2015. The increase in net loss per share was due to the year-over-year increase in operating expenses discussed above. |
| • | As of March 31, 2016, ContraFect had cash, cash equivalents and marketable securities of $26.3 million compared to $32.9 million at the end of 2015. |
About CF-301:
CF-301 is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staph aureus bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body’s natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect.
About CF-404:
CF-404 is a therapeutic cocktail composed of three fully human monoclonal antibodies targeted against the influenza virus. The cocktail consists of two antibodies targeting influenza A strains, and one antibody targeting influenza B strains, providing coverage for all human seasonal strains and most pandemic strains of influenza. These antibodies target a highly conserved region of the influenza hemagglutinin stem reducing the potential for resistance formation. This design of CF-404 allows for treatment without strain-specific diagnosis, redesign or annual reformulation.
About ContraFect:
ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (Methicillin-resistant Staphylococcus aureus) and influenza.
FORWARD-LOOKING STATEMENTS
This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding our ability to discover and develop protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, including whether CF-301 has the potential to be a first-in-class treatment for Staph aureus bloodstream infections including endocarditis, the analyses of the results of our Phase 1 study and animal studies, whether the 0.25 mg/kg dose will be effective in treating patients in our Phase 2 study, our ability to initiate a Phase 2 study of CF-301 in 4Q16 and our ability to file an IND for CF-404 in mid-2017. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations
and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Relations Contact
Paul Boni
ContraFect Corporation
Tel: 914-207-2300
Email: pboni@contrafect.com
CONTRAFECT CORPORATION
Balance Sheets
| March 31, 2016 |
December 31, 2015 |
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| (unaudited) | (audited) | |||||||
| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 7,638,646 | $ | 9,972,781 | ||||
| Marketable securities |
18,627,367 | 22,948,872 | ||||||
| Prepaid expenses and other current assets |
1,109,706 | 1,176,895 | ||||||
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| Total current assets |
27,375,719 | 34,098,548 | ||||||
| Property and equipment, net |
1,516,198 | 1,618,968 | ||||||
| Other assets |
143,621 | 143,621 | ||||||
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| Total assets |
$ | 29,035,538 | $ | 35,861,137 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities: |
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| Accounts payable |
$ | 1,821,341 | $ | 1,517,417 | ||||
| Accrued liabilities |
3,109,737 | 2,251,767 | ||||||
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| Total current liabilities |
4,931,078 | 3,769,184 | ||||||
| Deferred rent |
987,260 | 972,119 | ||||||
| Warrant liabilities |
256,054 | 444,324 | ||||||
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| Total liabilities |
6,174,392 | 5,185,627 | ||||||
| Commitments and contingencies |
— | — | ||||||
| Stockholders’ equity: |
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| Preferred stock, $0.0001 par value, 25,000,000 shares authorized and none outstanding at March 31, 2016 and December 31, 2015 |
— | — | ||||||
| Common stock, $0.0001 par value, 100,000,000 shares authorized; 27,485,542 and 27,482,692 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively |
2,748 | 2,748 | ||||||
| Additional paid-in capital |
149,363,352 | 148,282,546 | ||||||
| Accumulated other comprehensive loss |
(2,381 | ) | (30,373 | ) | ||||
| Accumulated deficit |
(126,502,573 | ) | (117,579,411 | ) | ||||
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| Total stockholders’ equity |
22,861,146 | 30,675,510 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 29,035,538 | $ | 35,861,137 | ||||
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CONTRAFECT CORPORATION
Unaudited Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Operating expenses: |
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| Research and development |
$ | 4,430,670 | $ | 2,422,106 | ||||
| General and administrative |
4,724,133 | 2,272,970 | ||||||
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| Total operating expenses |
9,154,803 | 4,695,076 | ||||||
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| Loss from operations |
(9,154,803 | ) | (4,695,076 | ) | ||||
| Other income (expense): |
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| Interest income |
43,371 | 55,368 | ||||||
| Change in fair value of warrant liabilities |
188,270 | (212,055 | ) | |||||
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| Total other income (expense) |
231,641 | (156,687 | ) | |||||
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| Net loss |
(8,923,162 | ) | (4,851,763 | ) | ||||
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| Per share information: |
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| Net loss per share of common stock, basic and diluted |
$ | (0.32 | ) | $ | (0.24 | ) | ||
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| Basic and diluted weighted average shares outstanding |
27,483,909 | 20,221,463 | ||||||
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The comparability of basic and diluted net loss per share and weighted average shares outstanding was impacted by the Company’s private placement of securities on June 12, 2015 and the issuance of shares upon the exercise of Class B warrants in October and November 2015.
The Company’s financial position as of March 31, 2016 and results of operations for the three months ended March 31, 2016 and 2015 have been extracted from the Company’s Quarterly Report on Form 10-Q. The Company’s financial position as of December 31, 2015 has been extracted from the Company’s audited financial statements included in its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2016. Certain prior period amounts have been reclassified to conform to current year presentation. You should refer to both the Company’s Quarterly Report on Form 10-Q and its Annual Report on Form 10-K for a complete discussion of financial information.