ContraFect Corporation (Nasdaq: CFRX), a late 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 announces presentation data showing DLA CF-370 is highly efficacious in a rabbit pneumonia model of a particularly hard-to-treat, extensively-drug-resistant (XDR) strain of Pseudomonas aeruginosa (P. aeruginosa), and also has the ability to both avoid antimicrobial resistance and suppress antibiotic resistance to commonly-used antibiotics in vitro. These data were recently presented at the 32^nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) Annual Meeting held from April 23-26, 2022 in Lisbon, Portugal.

“The wealth of data presented at ECCMID provide compelling evidence of the prospective potent efficacy and potentially promising utility of our direct lytic agents against life-threatening pathogens and combatting antimicrobial resistance,” stated Cara Cassino, M.D., Executive Vice President of Research & Development and Chief Medical Officer of ContraFect. “Importantly, we believe these data highlight the potential of CF-370 to demonstrate superior clinical outcomes in patients with hospital-acquired and ventilator-associated pneumonia, infectious diseases with high morbidity and mortality despite current standard of care with traditional antibiotics, which face the ongoing threat of increasing antimicrobial resistance.”

All meeting presentations and posters referenced below are available on the ContraFect website.

CF-370 ECCMID 2022 Presentations:

The studies discussed below further strengthen the potential for a new treatment paradigm of CF-370 used in addition to antibiotics, to achieve optimal efficacy outcomes for patients. In addition to the efficacy data, multiple serial passage studies highlight the favorable resistance profile of CF-370, including the potential ability to suppress resistance to current standard of care antibiotics. These attributes underpin the potential ability of direct lytic agents to mitigate antimicrobial resistance.

Oral Presentation Title: In vivo efficacy of CF-370 alone and in addition to amikacin in the rabbit acute pneumonia model caused by an extensively drug-resistant (XDR) Pseudomonas aeruginosa, AR-769

In this challenging rabbit model of pulmonary infection, multiple dose regimens of CF-370 administered alone and in addition to amikacin, significantly reduced bacteria counts by ~3.0 log₁₀ cfu/g tissue (p≤0.0004) compared to amikacin alone and by ~4.5 log₁₀ cfu/g tissue (p≤0.0003) compared to vehicle controls. Statistically significant reductions of bacteria counts in secondary organs of interest, the spleen and the kidney, were seen when CF-370 was administered in addition to amikacin compared to the administration of amikacin alone.

Poster Presentations:

Title:   Lysin CF-370 exhibits a low propensity for decreased susceptibility in Gram-negative (GN) ESKAPE pathogens

Utilizing the standard, rigorous 28-day serial passage method to induce in vitro resistance, CF-370 demonstrated an extremely low propensity for developing decreased susceptibility to the Gram-negative ESKAPE pathogens (P. aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae and Enterobacter cloacae) and Escherichia Coli. CF-370’s minimum inhibitory concentration (MIC) values did not change, except for a 2-fold increase with Enterobacter cloacae compared to MIC increases ranging from 32-fold to 512-fold for levofloxacin and ciprofloxacin.

Title:   Lysin CF-370 suppresses in vitro resistance in Pseudomonas aeruginosa to meropenem, tobramycin and levofloxacin

Using the 28-day serial passage method discussed above, CF-370 further demonstrated the ability to suppress in vitro resistance in P. aeruginosa to current standard of care antibiotics - meropenem, tobramycin and levofloxacin. With the addition of only 1/8x MIC of CF-370, resistance of P. aeruginosa was completely suppressed to both tobramycin and levofloxacin and increased only 2-fold to meropenem, compared to 4-fold, 16-fold and 32-fold MIC changes without CF-370.

CF-370 and Amurins ECCMID 2022 Poster Presentation:

Title:   Direct lytic agents, a novel family of antimicrobial agents, have a low propensity for decreased susceptibility in Gram-negative pathogens associated with airway infection in Cystic Fibrosis

Using the 28-day serial passage method discussed above, the Company’s DLAs, including CF-370 and the lead molecules from its amurin peptide program, all demonstrated an extremely low propensity for developing decreased susceptibility to Gram-negative pathogens associated with respiratory infections in Cystic Fibrosis patients - P. aeruginosa, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans. All DLAs tested had no change to MIC values compared to MIC increases ranging from 32-fold to 256-fold for levofloxacin and ciprofloxacin.

Exebacase ECCMID 2022 Poster Presentations:

Title: In vitro activity of exebacase against contemporary beta-haemolytic streptococci recovered from US patients with bloodstream infections

Exebacase demonstrated activity against a total of 149 BHS recovered from blood cultures collected as part of the SENTRY antimicrobial surveillance program, representing 5.2% of US BSI in the program. Exebacase MIC values ranged from 0.5-4.0 mg/L against Streptococcus agalactiae, Streptococcus pyogenes, and Streptococcus dysgalactiae, warranting further study of the potential for exebacase to treat BSI caused by BHS.

The studies below describe the optimization and expanded use of the exebacase MIC method in order to test additional target pathogens, such as beta-hemolytic streptococci (BHS), that have not been studied in clinical trials, but are relevant to bloodstream infections (BSI), including right-sided endocarditis. These studies are being performed in late-stage development to evaluate in vitro activity of exebacase against contemporary target pathogens relevant to the patient population under investigation in Phase 3 and for consideration of potential inclusion in product labeling.

Title: Evaluation of the broth microdilution MIC method for exebacase against 100 beta-haemolytic streptococci

Title:   Assessment of exebacase MIC reproducibility: Thirty S. aureus isolates tested at three sites using three different commercial media lots

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 and consequently unable to work in vitro in human blood or in animal models. However, based on the proprietary methods the Company has identified and utilizes to engineer lysins, CF-370 has exhibited the hallmark in vitro microbiologic attributes of the lysin class, including rapid and potent bactericidal activity, synergy with a broad range of standard of care agents 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, including hospital-acquired and ventilator-associated pneumonias and pulmonary exacerbations of cystic fibrosis.

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 was well-tolerated and treatment emergent adverse events, including serious treatment-emergent serious adverse events (SAEs) were balanced between the treatment groups. There were no SAEs determined to be related to exebacase, there were no reports of hypersensitivity related to exebacase and no patients discontinued treatment with study drug in either treatment group.

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. The lysin was licensed from The Rockefeller University and is being developed at ContraFect.

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 highly resistant strains of  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, currently being studied in a pivotal Phase 3 clinical study, was granted Breakthrough Therapy designation by the FDA for development as a treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics.

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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 ECCMID presentations, data presented and statements made regarding the same, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, CF-370 and exebacase attributes, 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 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 and other important risks detailed under the caption “Risk Factors” 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.

Investor Relations Contacts:

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ContraFect Corporation
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Media:

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