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YONKERS, N.Y., March 14, 2019 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of novel, differentiated biologic therapeutics for life-threatening, drug-resistant infectious diseases, today announced financial results for the fourth quarter and full year ended December 31, 2018.
“2018 was a milestone year for ContraFect. We completed enrollment of our Phase 2 superiority study for our lead product candidate, exebacase, and subsequently announced positive topline data that firmly established proof of concept for our novel lysin. The data further confirmed our belief that this new class of biologics has the potential to improve treatment outcomes in serious bacterial infections,” said Steven C. Gilman, Ph.D., Chairman and Chief Executive Officer of ContraFect. “We look forward to the full data readout in the first half of 2019 and the subsequent regulatory discussions to advance exebacase to a Phase 3 trial,” continued Dr. Gilman.
Completed Phase 2 Clinical Trial of Exebacase (CF-301)
Presented Clinical and Preclinical Data Supporting Exebacase and Gram-negative Lysins
Strengthened Balance Sheet
Fourth Quarter and Full Year 2018 Financial Results
ContraFect is a biotechnology company focused on discovering and developing differentiated biologic therapeutics 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 platform and through the use of other novel agents. Lysins are a new therapeutic class of bacteriophage-derived, recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. We believe that the properties of our lysins will make them suitable for targeting antibiotic-resistant organisms, such as Staph aureus and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. Our lead lysin candidate, exebacase (CF-301) is completing a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis and is the first lysin to enter clinical studies in the U.S.
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 the Company’s ability to discover and develop novel, differentiated biologic therapeutics for life-threatening, drug-resistant infectious diseases, whether 2018 was a milestone year for the Company, statements made regarding the announcement of Phase 2 study topline data and results, including that the results were positive, whether the topline data firmly established proof of concept, whether this new class of biologics has the potential to improve treatment outcomes in serious bacterial infections, the attainment of the full data readout in the first half of 2019, whether subsequent regulatory discussions will advance exebacase to a Phase 3 trial, statements made regarding the completion of the Phase 2 trial, whether exebacase has the potential to treat Staph aureus bacteremia, including endocarditis, whether exebacase demonstrated a robust safety and tolerability profile, statements made regarding the presentation of data, statements made regarding the Company balance sheet and financial results, the Company’s ability to address life threatening infections using our therapeutic product candidates from its lysin platform and through the use of other novel agents, whether lysins are a new therapeutic class of bacteriophage-derived, recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, and whether the properties of the Company’s lysins will make them suitable for targeting antibiotic-resistant organisms, such as Staph aureus and P. aeruginosa. 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.
Condensed Balance Sheets
|Cash and cash equivalents||$||8,320,317||$||6,995,046|
|Prepaid expenses and other current assets||988,779||1,848,063|
|Total current assets||31,441,052||48,701,973|
|Property and equipment, net||1,079,099||1,093,903|
|Liabilities and stockholders’ equity|
|Total stockholders’ equity||5,541,960||31,193,445|
|Total liabilities and stockholders’ equity||$||32,872,571||$||50,189,479|
Condensed Statements of Operations
|Three Months Ended December 31,||
Year Ended December 31,
|Research and development||$||6,718,522||$||4,420,431||$||22,416,651||$||17,314,086|
|General and administrative||2,125,990||2,984,004||8,707,774||9,249,671|
|Total operating expenses||8,844,512||7,404,435||31,124,425||26,563,757|
|Loss from operations||(8,844,512||)||(7,404,434||)||(31,124,425||)||(26,563,757||)|
|Other income (expense):||14,780,208||2,646,926||(6,559,999||)||11,046,099|
|Net income (loss)||$||5,935,696||$||(4,757,509||)||$||(37,684,424||)||$||(15,517,658||)|
|Net income (loss) per common share:|
|Weighted average shares:|
The comparability of basic and diluted net loss per share and weighted average shares outstanding was impacted by the Company’s follow-on offerings of securities in August 2018 and July 2017.
The Company's financial position as of December 31, 2018 and 2017 and results of operations for the years ended December 31, 2018 and 2017 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.
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