YONKERS, NY--(Marketwired - April 06, 2015) -
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ContraFect |
"ContraFect made significant achievements in 2014, most notably, in late December, the FDA approved CF-301, our most advanced lysin therapeutic to enter into human clinical trials. CF-301 is the first lysin ever approved by FDA to enter clinical trials, marking the beginning of the process to advance a new medicine to patients with serious Staph blood stream infections, including MRSA," said Julia P. Gregory, ContraFect's chief executive officer. "Additionally, we completed a successful IPO, which provided us with important funding."
Key Highlights:
- On December 22, 2014, we announced that the U.S. Food and Drug Administration (FDA) concluded the review of our complete response submission and it removed the full clinical hold on our investigational new drug (IND) application for CF-301, which allows us to initiate Phase I clinical trials. CF-301 represents a first-in-class anti-bacterial therapeutic agent. We intend to pursue an initial indication for CF-301 to be used in combination with standard of care antibiotics for the treatment of Staph aureus bacteremia, including endocarditis, caused by MSSA or MRSA. If we are able to obtain approval of CF-301 for this initial indication, we believe CF-301 can be further developed for the treatment of Staph aureus pneumonia, osteomyelitis, and biofilm-related indications for infected prosthetic joints, indwelling devices and catheters.
- On October 9, 2014, ContraFect entered into a collaborative research agreement with the National Institute for Viral Disease Control and Prevention, China CDC, to advance the research and development of CF-404, in the company's universal influenza treatment.
- In May, ContraFect's science was recognized by both the major peer-reviewed journal in our field, The Journal of Infectious Diseases,* and a leading industry conference, the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) where our Chief Scientific Officer was invited to give an oral presentation in August on our impressive endocarditis data.
- On April 24th, the Board of Directors appointed Mr. David N. Low Jr., Michael J. Otto, Ph.D. and Dr. Roger J. Pomerantz M.D., F.A.C.P. to the Board of Directors bringing substantial financial and infectious disease expertise to the Board.
Fourth Quarter and Full Year 2014 Financial Results:
For the quarter ended December 31, 2014, ContraFect reported a net loss attributable to common shareholders of $4.7 million, or $0.23 per share, as compared to a net loss attributable to common shareholders of $10.9 million, or $10.80 per share in the prior year period.
Operating expenses for the quarter ended December 31, 2014 were $4.8 million, with $2.3 million attributable to research and development. This compares to operating expenses of $7.4 million and research and development expenses of $2.5 million in the prior year period. The decrease is primarily due to lower headcount and personnel related costs. General and administrative expenses were $2.5 million for the quarter ended December 31, 2014, compared with $4.9 million in the prior year period.
For the twelve months ended December 31, 2014, ContraFect reported a net loss attributable to common shareholders of $34.6 million, or $3.86 per share, as compared to a net loss attributable to common shareholders of $23.6 million, or $23.35 per share for the year ended December 31, 2013. The net loss per share calculation for the year ended December 31, 2014, includes a preferred stock dividend in-kind of $4.5 million, or $0.50 per share, versus no such expense in 2013. The full year loss also included $11.1 million non-cash expenses recorded in other interest expense for the conversion of all of the Company's privately held securities into common stock on the closing of the IPO. These non-recurring, non-cash charges are one-time, and not indicative of future costs.
Operating expenses for the year ended December 31, 2014 were $16.9 million, with $8.9 million attributable to research and development. This compares to operating expenses of $19.3 million and research and development expenses of $9.1 million for the year ended December 31, 2013. The decrease is primarily due to lower headcount and personnel related costs, which was partially offset by the costs associated with our license from Trellis BioScience, LLC. General and administrative expenses were $8.1 million for the year ended December 31, 2014, compared with $10.2 million for the year ended December 31, 2013.
As of December 31, 2014, ContraFect had cash, and cash equivalents and marketable securities of $27.4 million versus $4.1 million at the close of 2013.
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. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant 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 (drug-resistant staphylococcus bacteria) and influenza.
FORWARD-LOOKING STATEMENTS
This press release contains "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" or similar references to future periods. 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. Specific forward-looking statements in this release include statements regarding the results of our Phase 1 clinical trial for CF-301. Actual results may differ from those set forth in the forward-looking statements. 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.
(Tables to Follow)
CONTRAFECT CORPORATION
Condensed Balance Sheets
December 31,
-------------------------
2014 2013
------------ ------------
Assets
Current assets:
Cash, cash equivalents and marketable
securities $ 27,393,059 $ 4,145,270
Prepaid expenses and other current assets 368,787 198,410
------------ ------------
Total current assets 27,761,846 4,343,680
Long-term assets 2,291,776 5,340,155
------------ ------------
Total assets $ 30,053,622 $ 9,683,835
============ ============
Liabilities and stockholders' deficit
Current liabilities $ 4,159,111 $ 7,116,846
Convertible notes payable and other long-term
liabilities 313,004 15,585,162
------------ ------------
Total liabilities 4,472,115 22,702,008
Total stockholders' equity (deficit) 25,581,507 (52,910,500)
------------ ------------
Total liabilities, convertible preferred stock,
and stockholders' equity (deficit) $ 30,053,622 $ 9,683,835
============ ============
CONTRAFECT CORPORATION
Statements of Operations
Three Months Ended
December 31, Year Ended December 31,
-------------------------- --------------------------
2014 2013 2014 2013
------------ ------------ ------------ ------------
(unaudited) (unaudited)
Operating expenses:
Research and
development $ 2,322,557 $ 2,532,070 $ 8,868,053 $ 9,133,175
General and
administrative 2,506,426 4,913,774 8,067,858 10,163,259
------------ ------------ ------------ ------------
Total operating
expenses 4,828,983 7,445,844 16,935,911 19,296,434
------------ ------------ ------------ ------------
Loss from operations (4,828,983) (7,445,844) (16,935,911) (19,296,434)
Other income
(expense)
Interest expense,
net 1,620 (873,402) (12,412,620) (1,712,178)
Refundable state
tax credits -- -- 424,649 --
Change in fair
value of warrant
and embedded
derivative
liabilities 90,692 (2,612,090) (1,225,202) (2,612,090)
------------ ------------ ------------ ------------
Total other income
(expense) 92,312 (3,485,492) (13,213,173) (4,324,268)
------------ ------------ ------------ ------------
Net loss (4,736,671) (10,931,336) (30,149,084) (23,620,702)
Preferred stock
dividend in-kind -- -- (4,468,452) --
------------ ------------ ------------ ------------
Net loss
attributable to
common
stockholders $ (4,736,671) $(10,931,336) $(34,617,536) $(23,620,702)
============ ============ ============ ============
Per share
information:
Net loss per share
of common stock,
basic and
diluted* $ (0.23) $ (10.80) $ (3.86) $ (23.35)
============ ============ ============ ============
Basic and diluted
weighted average
shares
outstanding* 20,207,191 1,011,997 8,973,599 1,011,789
============ ============ ============ ============
*Basic and diluted net loss per share attributable to common stockholders and weighted average shares outstanding were impacted by the conversion of all the Company's outstanding convertible preferred stock and convertible notes payable on the closing of the Company's initial public offering on August 1, 2014.
The Company's financial position as of December 31, 2014 and 2013 and results of operations for the years ended December 31, 2014 and 2013 have 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. You should refer to the Company's Annual Report on Form 10-K for a complete discussion of financial information.
Investor Relations Contact
Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact
Avonelle McLean
ContraFect Corporation
Email: Email Contact
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