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 announced results for the third quarter ended September 30, 2016. The Company ended the third quarter with cash, cash equivalents, and marketable securities of $43.2 million.
“We have made significant progress in the 3rd quarter as we continue to advance the development of our lead candidate, CF-301, a lysin therapeutic candidate for the treatment of Staphylococcus aureus bloodstream infections and endocarditis,” said Steven C. Gilman, Ph.D., ContraFect’s Chairman and CEO.
The Company has met with both the FDA and the Medical and Healthcare products Regulatory Agency (MHRA) to discuss the global clinical trial design. “Feedback from both agencies was positive, and the Company continues to move forward with identifying and selecting U.S. and international sites for the Phase 2 study in patients with Staphylococcus aureus bacteremia who need new therapeutic options,” said Cara Cassino, M.D., ContraFect’s Chief Medical Officer and Executive Vice President of Research and Development.
In addition, in August, ContraFect was granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA). The SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies.
The Company expects to initiate the Phase 2 study of CF-301 by year end, with the announcement of topline results in 2Q 2018.
Third Quarter 2016 Financial Results:
| • | Research and development expenses were $5.9 million for the third quarter of 2016 compared to $3.4 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 and IND-enabling activities for CF-404, including cGMP manufacturing. Our expenditures on CF-404 are expected to decrease significantly through the remainder of 2016 and into 2017 as cGMP manufacturing has been substantially completed. |
| • | General and administrative expenses were $1.9 million for the third quarter of 2016 compared to $2.4 million in the comparable period in 2015. The decrease in general and administrative expenses was primarily attributable to lower professional fees and share-based compensation expense. |
| • | Net loss was $10.5 million, or $0.28 per share, for the third quarter of 2016 compared to a net loss of $5.6 million, or $0.22 per share, for the comparable period in 2015. The increase in net loss per share was due to a $1.1 million of non-cash charges for the change in fair value of warrant liabilities, $1.6 million of non-recurring allocated offering costs and the year-over-year increase in operating expenses discussed above. | ||||
| • | As of September 30, 2016, ContraFect had cash, cash equivalents and marketable securities of $43.2 million compared to $32.9 million at the end of 2015. | ||||
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.
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 Staphylococcus aureus (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 and is the first lysin to enter clinical studies in the U.S.
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.
