“We remain on track to file an IND for our second program, CF-370, which is our engineered lysin targeting Gram-negative pathogens, in the third quarter. If we are ultimately able to provide doctors and patients with a totally new treatment modality for infections from Pseudomonas, Acinetobacter and Klebsiella, including the extreme antibiotic-resistant strains, we have the potential to significantly improve clinical outcomes and save lives,” said
Second Quarter 2023 Highlights and Recent Developments
- In
June 2023 , at ASM Microbe 2023 held inHouston, Texas , the Company presented multiple posters with new data on programs across its portfolio:
CF-370, a first-in-class engineered lysin with broad spectrum activity against Gram-negative pathogens
Data from multiple in vivo studies of the efficacy of CF-370 were presented. The administration of IV CF-370, in addition to either IV amikacin or meropenem, achieved significant reductions in bacterial densities compared to the administration of either antibiotic alone in neutropenic rabbit models of respiratory infection due to Klebsiella pneumoniae (K. pneumoniae). The results of these studies are consistent with the levels of efficacy seen in previously presented models of infection with other Gram-negative pathogens, including multi-drug (MDR) and extensively-resistant (XDR) strains Pseudomonas aeruginosa of (P. aeruginosa).
Data were also presented from a study of the relationship between CF-370 exposure and efficacy in a rabbit pneumonia model caused by a carbapenem-resistant P. aeruginosa. Consistent with the results seen in previous animal studies, CF-370 administered in addition to meropenem achieved a significant reduction in bacterial density compared to meropenem administered alone. Importantly, this study provided the Company with key data for determination of the appropriate PK target to drive clinical efficacy of CF-370 when administered in addition to standard of care antibiotics.
CF-296, a first-in-class engineered lysin with broad spectrum activity against Staphylococci
New data were presented from an in vivo study of CF-296 for the treatment of osteomyelitis resulting from methicillin-resistant Staphylococcus aureus (MRSA). CF-296, in addition to daptomycin, demonstrated the greatest reduction in the concentration of bacteria colonies in the bone. The study provides further support for the clinical study of DLAs as potential therapies for invasive, biofilm driven infections.
Engineered lysins with potent in vitro activity against Burkholderia spp. and Yersinia pestis
The Company presented data from multiple in vitro studies, including the determination of minimal inhibitory concentration (MIC) values, time-kill assays, fluorometric uptake assays for N-Phenyl-1-naphthylamine (NPN) to demonstrate the disruption of the outer membrane of Gram-negative bacteria and, to demonstrate safety and specificity, the data showed no impact of these lysins with regards to hemolysis of human red blood cells. The Company has selected lead lysins with highly potent and extremely rapid bactericidal activity for further preclinical development and progression into animal efficacy studies.
- In
June 2023 , the Company received$9.6 million from the exercise of common stock purchase warrants pursuant to an inducement agreement with an institutional investor. The proceeds are expected to be used to support the upcoming regulatory filing of an investigational new drug (IND) application for CF-370 and the subsequent initiation of Phase 1 single ascending and multiple ascending dose studies of CF-370 in healthy volunteers and to continue the enrollment of patients in the Phase 1b/2 clinical study of intra-articular exebacase for the treatment of chronic prosthetic joint infections (PJI). - In
April 2023 , the Company began dosing patients in the Phase 1b/2 study of exebacase in patients with chronic PJI due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS). The study is a randomized, double-blind, placebo-controlled clinical study conducted inFrance to assess the safety, pharmacokinetics (PK), and efficacy of intra-articularly administered exebacase in patients with chronic PJI of the knee due to S. aureus or CoNS. The study will be conducted in two parts. Part I will assess efficacy at an early, six-week timepoint in addition to safety and PK. Part II will be a long-term clinical safety and efficacy follow-up for a period of up to two years. Patients entering the study will be randomized 3:1 to either exebacase or placebo, with patients receiving study drug in the setting of a minimally-invasive arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) Procedure.
Second Quarter 2023 Financial Results
- Research and development (R&D) expenses were
$4.9 million for the second quarter of 2023 compared to$16.8 million in the comparable period in 2022. This decrease was primarily attributable to significantly reduced expenditures on chemistry, manufacturing and controls (CMC) activities for exebacase, contract research organizations (CROs) to support the completion of the Phase 3 DISRUPT study of exebacase, and external clinical consultants and headcount and related personnel costs as compared to the second quarter of 2022 when late-stage development activities were being progressed. - General and administrative (G&A) expenses were
$3.1 million for the second quarter of 2023 compared to$3.3 million in the comparable period in 2022. This decrease was primarily attributable to a decrease in personnel costs and related expenses. - Net loss was
$7.6 million , or a loss of$1.94 per share, for the second quarter of 2023 compared to net loss of$18.1 million , or a loss of$36.79 per share, for the comparable period in 2022. The net loss in the current period includes a$0.4 million , or$0.10 per share, non-cash charge related to the change in fair value of the Company’s warrant liabilities. In the prior year period, the net loss included a$1.9 million , or$3.90 per share, non-cash charge from the change in the fair value of the Company’s warrant liabilities. - As of
June 30, 2023 ,ContraFect had cash and cash equivalents of$14.4 million .
About
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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
Condensed Balance Sheets
(in thousands) | ||||||
2023 | 2022 | |||||
(unaudited) | (audited) | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 14,422 | $ | 8,907 | ||
Marketable securities | ― | 4,775 | ||||
Prepaid expenses | 1,521 | 1,382 | ||||
Other current assets | 571 | 2,642 | ||||
Total current assets | 16,514 | 17,706 | ||||
Property and equipment, net | 556 | 627 | ||||
Operating lease right-of-use assets | 2,077 | 2,241 | ||||
Other assets | 105 | 105 | ||||
Total assets | $ | 19,252 | $ | 20,679 | ||
Liabilities and stockholders’ deficit | ||||||
Current liabilities | $ | 16,473 | $ | 20,840 | ||
Warrant liabilities | 1,861 | 9,299 | ||||
Long-term portion of lease liabilities | 1,988 | 2,210 | ||||
Other liabilities | 38 | 182 | ||||
Total liabilities | 20,360 | 32,531 | ||||
Total stockholders’ deficit | (1,108 | ) | (11,852 | ) | ||
Total liabilities and stockholders’ deficit | $ | 19,252 | $ | 20,679 | ||
Unaudited Statements of Operations
(in thousands, except share and per-share data) | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
Operating expenses: | |||||||||||||
Research and development | $ | 4,870 | $ | 16,760 | $ | 10,165 | $ | 29,485 | |||||
General and administrative | 3,105 | 3,266 | 6,668 | 6,520 | |||||||||
Total operating expenses | 7,975 | 20,026 | 16,833 | 36,005 | |||||||||
Loss from operations | (7,975 | ) | (20,026 | ) | (16,833 | ) | (36,005 | ) | |||||
Other income (expense): | |||||||||||||
Interest income | 114 | 21 | 201 | 55 | |||||||||
Other expense | (96 | ) | ― | (96 | ) | ― | |||||||
Change in fair value of warrant liabilities | 389 | 1,916 | 7,789 | (2,296 | ) | ||||||||
Total other income (expense), net | 407 | 1,937 | 7,894 | (2,241 | ) | ||||||||
Net loss | $ | (7,568 | ) | $ | (18,089 | ) | $ | (8,939 | ) | $ | (38,246 | ) | |
Per share information: | |||||||||||||
Basic and diluted net loss per share | $ | (1.94 | ) | $ | (36.79 | ) | $ | (3.04 | ) | $ | (77.79 | ) | |
Shares used in computing net loss per share | 3,901,839 | 491,626 | 2,943,979 | 491,626 | |||||||||
In this release, management has presented its financial position as of
Investor Relations Contacts:
Email: mmessinger@contrafect.com
Source:
2023 GlobeNewswire, Inc., source