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Correction, not a job, it's my source of income , that I so happen to "LOVE" . You see, I have a passion for this. I can study for 18 hours . I get up 3am . I can spend hours on hours back testing my scanners ( that I build and create) and none of it gets me down. It's not so much about the money not ( yes I love the gains) However I enjoy the feeling of getting it right on my 100% plus profits trades. SO DO YOU FEEL THE SAME ABOUT YOUR HOBBY??
The difference between you and I when it comes to this is, "I LOVE THIS"
LOL, WOW. Not a hobby , it's my job I can't get all of them right 100% on GMBL, BIAF yesterday
I read that also, has not been confirmed
You have no clue, RS coming
Good move. I just read up on the DISRUPT Study, there may be a chance with CF-370?
DUMPED THIS IN AHs.....ready to get decimated into r/s
Vanguard Group Inc., Goldman Sachs Group Inc grew its stake ????
https://www.americanbankingnews.com/2023/01/17/contrafect-nasdaqcfrx-coverage-initiated-at-stocknews-com.html
Exebacase, a lysin, which is in "Phase III clinical trials" for the treatment of staphylococcus aureus bacteremia.
.13 AH .092 entry looking good. They are really trying to suppress CFRX run
https://finviz.com/quote.ashx?t=CFRX&ty=c&ta=1&p=d
maybe now 25% move on 3.9 mil vol.
Its ready now .09
I would have thought that there would have been more positive sentiment at this announcement.
ContraFect Announces ANSM Approval of Clinical Trial Application for Exebacase in Prosthetic Joint Infections
by
Globe Newswire
November 28, 2022 8:00 AM | 6 min read
https://www.benzinga.com/pressreleases/22/11/g29868511/contrafect-announces-ansm-approval-of-clinical-trial-application-for-exebacase-in-prosthetic-joint
YONKERS, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- ContraFect Corporation - CFRX
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, announces today that ANSM, the French National Agency for the Safety of Medicines and Health Products, has authorized its Clinical Trial Application (CTA) for the study of intra-articularly administered exebacase, in the setting of a minimally-invasive arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infection (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS).
"This is a significant milestone for our company as it represents the next opportunity for exebacase to recapitulate the positive and durable results we have observed clinically in the compassionate use setting, after dosing 16 patients. Exebacase presents the potential for a truly revolutionary change to the current treatment paradigm for patients with prosthetic joint infections, which consists of the chronic use of ineffective antibiotic agents leading to expensive and debilitating surgery, whereby the joint is removed and reimplanted 6 to 8 weeks after the patient's confinement to a hospital bed," said Roger J. Pomerantz, MD, President, Chief Executive Officer, and Chairman of ContraFect. "PJIs are a completely underserved area of medicine, where no randomized clinical trials have been completed. As the population of the developed world ages, we must find a safe, effective and minimally-invasive way to treat these infections or millions of patients will continue to suffer. Based on promising activity we have seen with exebacase in vitro, in vivo, and in compassionate uses to date, we look forward to completing what could be the first successful blinded and randomized trial in the field of PJIs."
The Phase 1b/2 study of exebacase is a randomized, double-blind, placebo-controlled two-part clinical study to be conducted in France to assess the efficacy and safety of exebacase in the setting of an arthroscopic DAIR procedure in patients with chronic PJI of the knee due to S. aureus and/or CoNS. Part 1 will evaluate the safety, PK, clinical outcomes, and microbiologic response in patients through Day 42. Up to 2 dose levels of intra-articularly administered exebacase in addition to systemic antibiotics will be studied in up to 2 patient cohorts. Part 2 will consist of a long-term follow-up study of safety and efficacy parameters in patients who complete Part 1 of the study. Follow-up assessments will be performed on Days 90, 180, 360 and 720.
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.
Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.
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 ANSM approval, the CTA and the clinical trial, statements made by Dr. Pomerantz, the conduct of the Phase 1b/2 study, ContraFect's ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, 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.
Investor Relations Contacts:
Michael Messinger
ContraFect Corporation
Tel: 914-207-2300
Email: mmessinger@contrafect.com
This has plenty of running room if it could just find the momentum.
I'm in @.1885 think she's finally gonna bounce.
Looks pretty ripe to me!!!
I'm ready. .25's and .24's. Looks like shorty is calling BS on the fundamentals. I was thinking the exact opposite.
https://finance.yahoo.com/news/cfrx-exebacase-shows-potent-antimicrobial-111500819.html?guccounter=1
This is now officially on my pincher list.
CFRX
Major up gap to fill. Delisting awarded time to comply to February and even the potential to be extended again.
Now CFRX just needs something to go their way.
https://finviz.com/quote.ashx?t=CFRX
Oversold..
CFRX daily
.314 she's pinching. So much room to run
Couldn't pass up adding more. Pinch this puppy!!
CFRX daily
looking for a bounce back to 50 cents
https://stockcharts.com/h-sc/ui?s=CFRX
another one I am in...
https://stockcharts.com/h-sc/ui?s=HGEN
Looks like the selling is close to being oversold.
Took a starter position here. 37M float
Pincher play as well.
https://schrts.co/WJbBgYGn
dead cat bounce coming
Wow isnt that low ? or .35 pps ? im confused ...
yes i agree.... can happen any moment
ADX & PPO coming together slowly.
It'll get there!
got in at 0.0358, 4k shares for dead cat bounce...
Interesting. Reduced to a 2.4% stake. Guess that'll be the last we see of them unless CFRX science can turn things around. It can happen.
https://ih.advfn.com/stock-market/NASDAQ/contrafect-CFRX/stock-news/88626941/amended-statement-of-ownership-sc-13g-a
They have a few other potential anti-bacterial products in their pipelines, but none were beyond preclinical testing other than Exebacase. And Exebacase just got stopped in Phase III testing - which is why stock prices just dropped like a stone.
Here's their described pipeline page
https://www.contrafect.com/pipeline/overview
Realistically - each of those other potential anti-bacterial products are years from being revenue generators.
If there is not some underlying positive angle that the company can redirect Exebacase toward, it's going to be a while before this company takes off and generates any revenue stream.
Is there anything positive about this company that may make me want to buy a bit?
Yeah - I am not necessarily giving up completely on this company, but I will probably see how things stabilize, and don't really have to get rid of the stock for tax purposes until December.
I might buy in again depending on how things look in 2023.
Not a total loss yet. The company still has another product under development.
CFRX: Results from Interim Futility Analysis in July 2022… - May 26, 2022
Business Update
Update on Phase 3 DISRUPT Trial
ContraFect, Corp. (NASDAQ:CFRX) is currently conducting the Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) trial of exebacase in patients with Staphylococcus aureus bacteremia, including right-sided endocarditis. The DISRUPT trial is a randomized, double blind, placebo controlled study being conducted at over 40 centers in the U.S. and will enroll approximately 350 patients randomized 2:1 to receive either exebacase or placebo, with all patients receiving standard of care antibiotics.
The company recently announced that the DISRUPT trial has passed the enrollment threshold necessary for the interim futility analysis. The trial has currently approximately two-thirds of the entire study population enrolled. The interim futility analysis will be conducted by the Data Safety Monitoring Board (DSMB) and will include an assessment of the probability for exebacase to achieve superiority on the primary efficacy endpoint. We anticipate the results of the interim futility analysis in July 2022.
The primary endpoint of the trial is clinical response at Day 14 in patients with methicillin-resistant S. aureus (MRSA) bacteremia, including right-sided endocarditis. Clinical response is defined using objective clinical criteria including: 1) resolution of S. aureus bacteremia/right-sided endocarditis signs and symptoms that were present at baseline; 2) no new signs or symptoms of bacteremia/right-sided endocarditis; 3) no complications of bacteremia/right-sided endocarditis; 4) no changes in anti-staphylococcal antibiotics after treatment with study drug due to persistence, worsening, or recurrence of signs or symptoms of bacteremia/right-sided endocarditis; 5) blood cultures negative for S. aureus by Day 14; and 6) the patient is alive. Clinical response is being determined by an independent, blinded clinical adjudication committee.
Key secondary endpoints include clinical response rate at Day 14 for all S. aureus bacteremia patients (including both MRSA and methicillin-sensitive S. aureus [MSSA]), 30-day all-cause mortality in MRSA patients, and clinical response at Day 60. The company will also evaluate the impact of treatment with exebacase on length of hospital stay, length of stay in the intensive care unit, and 30-day readmission rates for both all-cause and S. aureus infection readmissions.
In March 2021, ContraFect announced an $86.8 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the DISRUPT trial. The company received an initial tranche of $9.8 million with up to $77.0 million in future support being dependent on progress and clinical success in the DISRUPT trial. Following completion of the trial, and assuming a positive outcome, the BARDA funding can be used to support additional development work that may be necessary for FDA approval, including manufacturing and regulatory activities. It could also cover any post-approval commitments, such as the completion of the pediatric study.
Multiple Presentations on CF-370 at ECCMID
In April 2022, ContraFect announced multiple presentations on CF-370 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) Annual Meeting, which included its activity in an in vivo model and in vitro analysis of its susceptibility to resistance.
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
This study utilized a rabbit model of pulmonary infection induced by Pseudomonas aeruginosa and examined two doses of CF-370 (3 and 10 mg/kg, iv, single dose), two doses of CF-370 (3 and 10 mg/kg, iv, single dose) in combination with amikacin (4 mg/kg, iv, 3 doses every 8 hours), amikacin alone, vehicle control, and an untreated cohort. Results showed that CF-370, when administered alone and in combination with amikacin, significantly reduced bacterial counts by approximately 3.0 log10 cfu/g tissue when compared to amikacin alone (P≤0.0004) and by approximately 4.5 log10 cfu/g tissue when compared to vehicle control . In addition, significantly reduced bacterial counts were seen in secondary organs of interest (spleen and kidney) when CF-370 was administered in combination with amikacin compared to amikacin alone.
Lysin CF-370 exhibits a low propensity for decreased susceptibility in Gram-negative (GN) ESKAPE pathogens
This study utilized the standard 28-day serial passage method to induce in vitro resistance against CF-370, ciprofloxacin, and levofloxacin. CF-370 had 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. Minimum inhibitory concentrations (MICs) for CF-370 did not change against any of the pathogens, except for a 2-fold increase with E. cloacae. In contrast, MIC increases ranged from 32-fold to 512-fold for levofloxacin and ciprofloxacin.
Lysin CF-370 suppresses in vitro resistance in Pseudomonas aeruginosa to meropenem, tobramycin and levofloxacin
This study utilized the 28-day serial passage method to test whether CF-370 could suppress in vitro resistance in P. aeruginosa to current standard of care antibiotics (meropenem, tobramycin, and levofloxacin). The addition of CF-370 at only 1/8x MIC completely repressed resistance of P. aeruginosa 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, respectively.
Financial Update
On May 16, 2022, ContraFect announced financial results for the first quarter of 2022. As expected, the company did not report any revenues for the three months ending March 31, 2022. Net loss for the first quarter of 2022 was $20.2 million, or $0.51 per share, compared to a net loss of $5.2 million, or $0.18 per share, for the first quarter of 2021. R&D expenses for the first quarter of 2022 were $12.7 million, compared to $8.0 million for the first quarter of 2021. The increase was primarily due to an increase in spending on manufacturing costs that will support a potential BLA submission and clinical activities associated with the Phase 3 DISRUPT trial. G&A expenses for the first quarter of 2022 were $3.3 million, compared to $2.8 million for the first quarter of 2021. The increase was primarily due to increased personnel and related expenses.
As of March 31, 2022, ContraFect had approximately $42.3 million in cash, cash equivalents, and marketable securities. As of May 10, 2022, the company had approximately 39.3 million shares outstanding and, when factoring stock options and warrants, a fully diluted share count of approximately 54.4 million.
Conclusion
We are anxiously awaiting the results of the planned interim futility analysis for the Phase 3 DISRUPT trial, which we now expect in July 2022. The data presented at ECCMID for CF-370 is very encouraging and we will be following its development very closely, with IND-enabling activities currently ongoing. As we await the results of the interim futility analysis we have made no changes to our model and our valuation remains at $23 per share.
Mine was in my IRA. Watching LII's and the chart for the dead cat bounce. Figure if the rest of their pipeline even has a chance it'll stll be a long time before this sees over the $ again. The data suggests that they still may be able to tweak a bit here and there and make another go of it. We'll see that possibility in a month or so.
The company plans to provide further details regarding the development of exebacase following completion of its own analysis of the accrued study data.
While I may not stick around to find out I may keep an eye on it for the future. IMO, they have a good team put together that has pretty good potential for the future.
Edit: This also on a day that the market gets the crap kicked out of it. The bounce may not be till tomorrow. Took some .54's.
So it goes with clinical-stage biotechs,... I guess I will be using the tax write off this year on this one.
Yes it was. Very disappointing.
Right at close. Of course.
s-
Yeap ...
Best,
G
HDG,
Bummer on futility. It is a NO-GO.
Regards,
Spiky
s-
I expect - as best case - a back to +/- 0 for close, every day till announcement due to AH news fears.
Best,
G
Well - share prices to seem to have gone somewhat green for the day.
HDG,
Volume is starting to pick up. Let’s see where this heads into the afternoon.
At least so far there is support for the stock price.
Regards,
Spiky
s-
DSMB seems late based on the original estimate of 1st week of July.
It seems like CFRX is still expecting results anytime soon. If not soon they had a chance to release an updated guidance.
HDG,
DSMB seems late based on the original estimate of 1st week of July.
It seems like CFRX is still expecting results anytime soon. If not soon they had a chance to release an updated guidance.
Regards,
Spiky
s-
No idea what is going on ...
- app. 80k (20% of regular) in AH on Friday with additional - $0.45
- down - $0.46 in PM (9k volume)
Meanwhile no Friday AH news ... no news yet. (usual PM release time: 07:30 ET)
Best,
G
s-
I felt that volume was not that high to suggest a leak, so I held onto my position
CFRX diluted a day after announcing the BARDA grant.
I plan to sell all of my position when market opens, assuming CFRX release info pre market.
HDG,
I was watching the volume Friday afternoon to see if news was somehow leaked and that CFRX was going to give bad news after market close. I felt that volume was not that high to suggest a leak, so I held onto my position.
I agree with you, of expecting a GO for futility and a dilution afterwards. Back in March 2021, CFRX diluted a day after announcing the BARDA grant. I plan to sell all of my position when market opens, assuming CFRX release info pre market.
Regards,
Spiky
s-
I know Instead of Super Tuesday it was a Black Friday ("SALE" on Friday only back to "standard" price next week?).
Meanwhile the movement during the day - especially until app 3 PM ... maybe till close - was "understandable: potential AH news on Friday (usually a bad news) I have no idea why the AH looks like as it is additional -15% with the volume (20% of the regular volume, 50+% of average volume.
I could think only one thing: I still assume "Go" a good news but dilution is coming also.
Best,
G
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