Continued execution to advance exebacase and CF-370 into new clinical studies
YONKERS, N.Y., Nov. 14, 2022 (GLOBE NEWSWIRE) — ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced financial results and business updates for the third quarter ended September 30, 2022.
“I am quite proud of our team at ContraFect, as we worked through significant, unexpected adversity while continuing to successfully execute on our near-term objectives. We submitted a CTA to ANSM, the French regulatory agency, to begin a Phase 1b/2 clinical study of intra-articular exebacase in patients with chronic prosthetic joint infections of the knee. In addition, we completed the GLP toxicology studies of CF-370, our lysin for the potential treatment of important Gram-negative infections, including resistant Pseudomonas, Acinetobacter and Klebsiella, and expect to submit an IND for CF-370 by the end of the first quarter of 2023. We also completed the patient monitoring and follow-up of the final patients of the DISRUPT study and look to achieve database lock in December. We expect to communicate the results from the full study population in the first half of 2023 and from our own analysis of the futility analysis dataset shortly after database lock, or earlier if possible,” said Roger J. Pomerantz, M.D., President, Chief Executive Officer, and Chairman of ContraFect. “We are excited about 2023 and the prospect of having two different programs in the clinic, with the potential to demonstrate that we can significantly improve clinical outcomes for patients suffering from deadly and debilitating resistant bacterial infections,” added Dr. Pomerantz.
Third Quarter 2022 Highlights and Recent Developments
Third Quarter 2022 Financial Results
About ContraFect:
ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. 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 platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are 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. Amurin peptides are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase, which is the first lysin to enter clinical studies in the U.S. Exebacase was granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.
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Activities related to exebacase during the period of performance under the contract will be funded in part with federal funds from HHS; ASPR; BARDA, under contract number 75A501212C00021.
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 the continued advancement of exebacase and CF-370, whether the company will execute near-term objectives, the ongoing analysis of the data sets from the Phase 3 clinical study of exebacase, timing and expectations surrounding: the ANSM CTA submission, initiation of patient dosing in the Phase 1b/2 clinical study, CF-370 tox studies, the CF-370 IND submission, and DISRUPT study activities including: database lock, patient monitoring and follow-up, analysis of results and communication of those results, statements made by Dr. Pomerantz, whether the company can significantly improve clinical outcomes for patients suffering from deadly and debilitating resistant bacterial infections ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, the Company’s financial results, financial position, balance sheets and statements of operations, exebacase and CF-370 attributes, the potential therapeutic utility of CF-370, whether ContraFect will address life-threatening infections using therapeutic candidates from its DLA platform, whether lysins are a new class of DLAs which are 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, whether amurins are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA 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, without limitation, that ContraFect has and expects to continue to incur significant losses, ContraFect’s need for additional funding, which may not be available, the occurrence of any adverse events related to the discovery, development and commercialization of ContraFect’s product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection, changes in management may negatively affect ContraFect’s business and other important risks detailed under the caption “Risk Factors” in ContraFect’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and its other filings with the Securities and Exchange Commission. 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.
CONTRAFECT CORPORATION
Condensed Balance Sheets
(in thousands)
September 30, 2022 |
December 31, 2021 |
||||
(unaudited) | (audited) | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 4,664 | $ | 16,654 | |
Marketable securities | 12,984 | 37,631 | |||
Prepaid expenses | 1,815 | 4,439 | |||
Other current assets | 586 | 4,140 | |||
Total current assets | 20,049 | 62,864 | |||
Property and equipment, net | 628 | 741 | |||
Operating lease right-of-use assets | 2,249 | 2,544 | |||
Other assets | 108 | 613 | |||
Total assets | $ | 23,034 | $ | 66,762 | |
Liabilities and stockholders’ (deficit) equity | |||||
Current liabilities | $ | 23,783 | $ | 12,174 | |
Warrant liabilities | 3 | 2,530 | |||
Long-term portion of lease liabilities | 2,313 | 2,609 | |||
Other liabilities | 38 | 73 | |||
Total liabilities | 26,137 | 17,386 | |||
Total stockholders’ (deficit) equity | (3,013 | ) | 49,376 | ||
Total liabilities and stockholders’ (deficit) equity | $ | 23,034 | $ | 66,762 |
CONTRAFECT CORPORATION
Unaudited Statements of Operations
(in thousands, except share and per-share data) | ||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 10,814 | $ | 8,664 | $ | 40,299 | $ | 24,462 | ||||
General and administrative | 3,366 | 3,022 | 9,886 | 8,722 | ||||||||
Restructuring | 7,719 | ― | 7,719 | ― | ||||||||
Total operating expenses | 21,899 | 11,686 | 57,904 | 33,184 | ||||||||
Loss from operations | (21,899 | ) | (11,686 | ) | (57,904 | ) | (33,184 | ) | ||||
Other income: | ||||||||||||
Interest income, net | 9 | 36 | 64 | 91 | ||||||||
Change in fair value of warrant liabilities | 4,823 | 6,358 | 2,527 | 17,210 | ||||||||
Total other income, net | 4,832 | 6,394 | 2,591 | 17,301 | ||||||||
Net loss | $ | (17,067 | ) | $ | (5,292 | ) | $ | (55,313 | ) | $ | (15,883 | ) |
Per share information: | ||||||||||||
Basic and diluted net loss per share | $ | (0.43 | ) | $ | (0.13 | ) | $ | (1.41 | ) | $ | (0.44 | ) |
Shares used in computing net loss per share | 39,332,721 | 39,332,721 | 39,332,721 | 35,914,327 | ||||||||
In this release, management has presented its financial position as of September 30, 2022 and its operating results for the three and nine months ended September 30, 2022 and 2021 in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The Company’s financial position as of December 31, 2021 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 25, 2021. 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.
Investor Relations Contacts:
Michael Messinger
ContraFect Corporation
Tel: 914-207-2300
Email: mmessinger@contrafect.com
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