“We continue to make important progress across our extensive portfolio, as we generate and publish new and compelling data highlighting the potential meaningful improvements for patients that we have observed in a variety of difficult to treat infections. Our primary focus remains on the enrollment of patients in the Phase 3 DISRUPT superiority study of our Breakthrough Therapy, new modality drug, exebacase, in patients with Staph aureus bloodstream infections. We now have nearly 60 active clinical sites and we continue to accumulate patients every month, despite the ongoing COVID-19 pandemic. In addition, we remain vigilant in our financial management and will continue to provide our shareholders with relevant updates as they emerge,” said
As previously communicated, the pandemic has caused some delays in patient enrollment during certain months of this year, as hospitals struggle to recover from the surges in COVID-19 infections and hospitalizations.
Recent Corporate Highlights
- In October, the Company presented important new data at IDWeek 2021, in a late breaker, oral presentation, from the Phase 2 study of exebacase. These data demonstrated that exebacase, used in addition to SOCA, more rapidly resolved clinical symptoms of Staph aureus bacteremia versus SOCA alone. The median time to resolution was 3 days for exebacase-treated patients, as compared to 6 days for SOCA-alone patients. Notably, among the exebacase-treated patients with MRSA bacteremia, the median time to symptom resolution was 3 days, as compared to 7 days in patients who received SOCA alone. Additionally, 94.1% of exebacase-treated patients with MRSA bacteremia showed symptom resolution, compared with only 81.8% MRSA bacteremia patients treated with SOCA alone.
- In October, new surveillance data was presented at IDWeek 2021 on the in vitro activity of exebacase against Staph aureus causing bacteremia in
the United States , including multidrug-resistant (MDR) strains. The data showed that Staph aureus accounted for approximately 25% of all pathogens recovered from blood specimens and nearly 40% of Staph aureus infected samples were of a methicillin-resistant phenotype. These data demonstrated the potent activity of exebacase and that its activity was consistent, regardless of resistance phenotype (MSSA , MRSA, including MDR isolates). - In October,
ContraFect announced the poster presentation on the activity of DLAs against the most prevalent MDR pathogenic strains responsible for pulmonary infections in Cystic Fibrosis patients at theNorth American Cystic Fibrosis Conference . The data further support the in vitro activity profile of CF-370 and amurin AM1 against specific Gram-negative pathogens, including Pseudomonas aeruginosa (P. aeruginosa), Stenotrophomonas maltophilia, and Achromobacter spp. - In July, new data was presented at the 31st
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) demonstrating the in vitro synergy for anti-biofilm activity of exebacase with either rifampin, vancomycin, or daptomycin against Staph epidermidis strains responsible for bone and joint infections of the knee, hip and shoulder. These data add to the evidence supporting the potential for exebacase to treat Staph epidermidis infections of prosthetic joints. - In July, new data were presented at the 31st
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) demonstrating the potent in vitro activity of CF-370 against clinical MDR and extreme drug-resistant (XDR) P. aeruginosa isolates, including carbapenem and colistin resistant forms. Isolates included those from theCenters for Disease Control Antibiotic Resistance Bank .
Third Quarter 2021 Financial Results
- Research and development (R&D) expenses were
$8.7 million for the third quarter of 2021 compared to$4.7 million in the comparable period in 2020. This increase was primarily attributable to an increase in CRO and investigator site expenses related to the execution of the Phase 3 clinical study, an increase in expenditures for non-clinical studies of exebacase, CF-370, CF-296 and the amurin peptides, as all programs continued to progress forward, and an increase in clinical development and manufacturing headcount and related personnel costs to support the ongoing development of exebacase. - General and administrative (G&A) expenses were
$3.0 million for the third quarter of 2021 compared to$2.6 million in the comparable period in 2020. This increase was primarily attributable to an increase in administrative personnel and insurance costs, which was partially offset by a decrease in legal expenses. - Net loss was
$5.3 million , or a loss of$(0.13) per share, for the third quarter of 2021 compared to net income of$3.4 million , or income of$0.12 per share, for the comparable period in 2020. The net loss per share in the current period includes a$6.4 million , or$0.16 per share, non-cash gain from the change in the fair value of the Company’s warrant liabilities. In the prior year period, the net income per share included a$10.7 million , or$0.38 per share, non-cash gain from the change in the fair value of the Company’s warrant liabilities. - As of
September 30, 2021 ,ContraFect had cash, cash equivalents and marketable securities of$63.3 million .
About Exebacase (CF-301):
Exebacase is a recombinantly-produced lysin (cell wall hydrolase enzyme) with potent bactericidal activity against Staph aureus, a major cause of bloodstream infections (BSIs) also known as bacteremia. In the Company’s Phase 2 study of exebacase, a pre-specified analysis of MRSA-infected patients showed that the clinical responder rate at Day 14 in patients treated with exebacase was nearly 43-percentage points higher than in patients treated with SOC antibiotics alone (74.1% for patients treated with exebacase compared to 31.3% for patients treated with SOC antibiotics alone (p=0.010)). In addition to the higher rate of clinical response, MRSA-infected patients treated with exebacase showed a 21-percentage point reduction in 30-day all-cause mortality (p=0.056), a four-day lower median length of hospital stay and meaningful reductions in hospital readmission rates. Exebacase is currently being studied in the Phase 3 DISRUPT superiority design study of exebacase in patients with Staph aureus bacteremia, including right-sided endocarditis.
Exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia. Exebacase was licensed from
About CF-370:
CF-370 is an investigational first-in-class therapeutic candidate targeting P. aeruginosa, a Gram-negative pathogen. CF-370 has been engineered to bypass the outer membrane of the bacteria and to enable potent activity in human serum. The Company believes this is a significant milestone for direct lytic agents as native lysins are typically unable to penetrate the outer membrane of Gram-negative bacteria. However, based on the proprietary methods the Company has identified and utilizes to engineer lysins, CF-370 has exhibited the microbiologic attributes of the lysin class, including rapid and potent bactericidal activity, synergy with a broad range of standard of care antibiotics and the eradication of biofilms in preclinical studies. The promising data from animal models support the potential therapeutic utility of CF-370 for the treatment of serious infections caused by P. aeruginosa.
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) | |||||
2021 | 2020 | ||||
(unaudited) | (audited) | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 20,225 | $ | 15,485 | |
Marketable securities | 43,092 | 27,005 | |||
Prepaid expenses and other current assets | 11,022 | 4,165 | |||
Total current assets | 74,339 | 46,655 | |||
Property and equipment, net | 784 | 910 | |||
Operating lease right-of-use assets | 2,614 | 2,811 | |||
Other assets | 105 | 740 | |||
Total assets | $ | 77,842 | $ | 51,116 | |
Liabilities and stockholders’ equity | |||||
Current liabilities | $ | 9,869 | $ | 6,060 | |
Warrant liabilities | 12,194 | 29,404 | |||
Long-term portion of lease liabilities | 2,700 | 2,959 | |||
Other liabilities | 73 | 73 | |||
Total liabilities | 24,836 | 38,496 | |||
Total stockholders’ equity | 53,006 | 12,620 | |||
Total liabilities and stockholders’ equity | $ | 77,842 | $ | 51,116 | |
Unaudited Statements of Operations
(in thousands, except share and per-share data) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 8,664 | $ | 4,706 | $ | 24,462 | $ | 15,354 | |||||||
General and administrative | 3,022 | 2,607 | 8,722 | 8,186 | |||||||||||
Total operating expenses | 11,686 | 7,313 | 33,184 | 23,540 | |||||||||||
Loss from operations | (11,686 | ) | (7,313 | ) | (33,184 | ) | (23,540 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 36 | 58 | 91 | 154 | |||||||||||
Other income (expense) | — | 10 | — | (2,165 | ) | ||||||||||
Change in fair value of warrant liabilities | 6,358 | 10,689 | 17,210 | 3,800 | |||||||||||
Total other income | 6,394 | 10,757 | 17,301 | 1,789 | |||||||||||
Net income (loss) | $ | (5,292 | ) | $ | 3,444 | $ | (15,883 | ) | $ | (21,751 | ) | ||||
Per share information: | |||||||||||||||
Basic net income (loss) per share | $ | (0.13 | ) | $ | 0.12 | $ | (0.44 | ) | $ | (1.03 | ) | ||||
(in thousands, except share and per-share data)
Three Months Ended | Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Shares used in computing basic net income (loss) per share | 39,332,721 | 27,809,169 | 35,914,327 | 21,069,057 | |||||||||||
Diluted net loss per share | $ | (0.13 | ) | $ | (0.19 | ) | $ | (0.44 | ) | $ | (1.03 | ) | |||
Shares used in computing diluted net loss per share | 39,332,721 | 29,079,107 | 35,914,327 | 21,069,057 | |||||||||||
In this release, management has presented its financial position as of
Investor Relations Contacts:
Tel: 914-207-2300
Email: mmessinger@contrafect.com
CORE IR
Tel: 917-885-7378
Julesa@coreir.com
Source:
2021 GlobeNewswire, Inc., source