Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
That should be a good thing. Focus on where it matters most and cut spending
ceo sent out a shareholder letter that they are cutting workforce and closing a france office to conserve cash
I didn’t get what warranted this sell-off
mms trying to steal oversold cheapies
The diseases targeted by our drug candidates remain woefully underserved by current therapeutic options, which we believe provides First Wave BioPharma with the opportunity to address multiple large and growing patient populations. In the U.S., the ulcerative colitis market is currently estimated at $5 billion, while Crohn’s disease is estimated at $7.4 billion and EPI at $2 billion.
As a company, we continue to be driven by the mission of bringing relief to patients living daily with the often painful, dangerous, and discomforting symptoms inherent to GI disease, to protect their health and to restore quality of life.
Sincerely,
James Sapirstein
Chairman, President and CEO
First Wave BioPharma, Inc.
While our FW-UP program is our most advanced, we are also developing formulations of niclosamide for pancolitis, a form of ulcerative colitis (FW-UC) and Crohn’s disease (FW-CD). To that end, earlier this week we announced the creation of an IBD Steering Committee comprised of four globally renowned experts in GI diseases, including UC and CD, to provide scientific and clinical guidance as we advance our programs.
Additionally, we continue to advance adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). We have made significant progress in identifying a microbead formulation delivery technology, which we believe will ensure the consistent delivery of the drug to the small intestine at therapeutically relevant levels. Our R&D team recently completed a white paper detailing the continued development of the microbead formulation and the benefits that it is expected to provide. A copy of that white paper may be accessed via the following link:
Adrulipase White Paper
Overall, we remain confident in our inflammatory bowel disease (IBD) programs given niclosamide’s anti-inflammatory mechanism of action. In short, research indicates that IBDs, including ulcerative colitis (UC) and Crohn’s disease (CD), are driven by pathogenic Th17 cells, which release a cascade of local cytokines that in turn cause inflammation in bowel wall tissues. Niclosamide is known to disrupt the oxidative phosphorylation in the mitochondria of pathogenic Th17 cells in a manner that selectively induces apoptosis of pathogenic Th17 cells, overcoming their inherent resistance to cell death. By killing Th17 cells, niclosamide reduces inflammation and calms the gut, selectively killing pathogenic, inflammatory cells while leaving healthy cells untouched.
While the top-line efficacy measure from the RESERVOIR trial did not show any anti-viral activity, the drug was well-tolerated without any serious adverse events. We believe this will continue to be the case for our ongoing clinical program of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), two forms of ulcerative colitis (UC). We look forward to the upcoming poster presentation at the 2022 Digestive Disease Week (DDW) Conference on data from a Phase 1 open label study of niclosamide as a potential treatment for patients with mild to moderate UP and UPS.
major overeaction...
omg.wtf? r u still in pal?
$FWBI NEWS!!!!! First Wave BioPharma Forms Clinical Steering Committee Focused on Advancing Inflammatory Bowel Disease (IBD) Product Portfolio
April 27 2022 - 07:00AM
First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the formation of a clinical steering committee focused on advancing the Company’s inflammatory bowel disease (IBD) product portfolio, including FW-UP (ulcerative proctitis and ulcerative proctosigmoiditis), FW-UC (ulcerative colitis) and FW-CD (Crohn’s disease). First Wave BioPharma is currently advancing a Phase 2 clinical trial investigating FW-UP, a topical formulation of niclosamide, for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS).
The four-member steering committee will provide management with strategic guidance and support during the execution of the FW-UP Phase 2 trial as well as the advancement of clinical programs for FW-UC and FW-CD. The committee members include Brian Feagan, M.D., Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director, Alimentiv, Inc.; Stephen B. Hanauer, M.D., Medical Director of the Digestive Health Center at Northwestern Medicine and Clifford Joseph Barborka Professor of Medicine in the Northwestern Feinberg School of Medicine; Giovanni Monteleone, M.D., Professor and Head, Department of Gastroenterology at the University of Rome Tor Vergata; and Julian Panes, M.D., Professor of Medicine and the Chief of the Department of Gastroenterology at Hospital Clinic de Barcelona.
“Our inflammatory bowel disease product portfolio, led by FW-UP, is a significant near-term and longer-range growth driver for First Wave BioPharma and was a key factor in our decision to acquire First Wave Bio. Given this importance to the company, we are very excited to announce the formation of a clinical steering committee comprised of world-renowned experts in IBD,” stated James Sapirstein, President and CEO of First Wave BioPharma. “Each committee member brings extensive expertise as researchers and clinicians in the treatment of gastrointestinal and inflammatory bowel diseases, including ulcerative colitis and Crohn’s disease. We expect to benefit immediately from their collective experience as we accelerate our FW-UP program and look to initiate clinical trials of FW-UC and FW-CD.”
About the IBD Steering Committee
Dr. Brian Feagan is a world-renowned gastroenterologist, with expertise in inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn’s disease. He currently serves as Professor of Medicine, Epidemiology and Biostatistics at Western University and Senior Scientific Director at Alimentiv, Inc. Dr. Feagan’s research efforts focus on the design and implementation of randomized controlled trials of therapy for IBD. He has served as principal investigator on more than 140 multi-center clinical trials focused on novel IBD therapeutics.
Dr. Stephen Hanauer currently serves as Medical Director of the Digestive Health Center at Northwestern Medicine and is a Clifford Joseph Barborka Professor of Medicine in the Northwestern Feinberg School of Medicine. Dr. Hanauer is board certified in internal medicine and gastroenterology by the American Board of Internal Medicine and the American Board of Gastroenterology, respectively. He holds membership in several professional societies and is a Fellow of American Gastroenterological Association, the American College of Gastroenterology and the American College of Physicians. In connection with the American Gastroenterological Association (AGA), Dr. Hanauer served as chair for the Inflammation, Immunology, and Inflammatory Bowel Disease Section and the Clinical Practice Section and subsequently served as Councilor for Clinical Research on the AGA Governing Board. He is a prior member of the Specialty Board of the American Board of Internal Medicine. Among his many honors, Dr. Hanauer received the AGA Fiterman Foundation Joseph B. Kirsner Award in Gastroenterology in 2001 and the Janssen Award for Clinical Excellence in 2004. He has served as a Member and Chair of the U.S. Food and Drug Administration Advisory Panel for Gastrointestinal Disorders and is a member and former Chairman of the International Organization for Inflammatory Bowel Disease.
Dr. Giovanni Monteleone is a Professor and Head of the Department of Gastroenterology at the University of Rome Tor Vergata in Rome, Italy and serves as the lead investigator in First Wave BioPharma’s Phase 2 clinical trial investigating a topical formulation of niclosamide (FW-UP) as a potential treatment for patients with ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). Since joining the faculty at the University of Rome Tor Vergata in 2003, Dr. Monteleone has pursued research on the mechanisms involved in the control of mucosal immune homeostasis and inflammatory signals that sustain and amplify pathological processes in the gastrointestinal tract that has contributed to delineating novel pathways of intestinal mucosal damage and the development of anti-inflammatory compounds. Dr. Monteleone has authored 300 peer-reviewed articles, books, and book chapters, and serves as an editorial board member for several medical journals. He received his medical degree from the University Magna Graecia of Catanzaro in Italy, where he also completed an internship, a residency, and a fellowship in gastroenterology.
Dr. Julian Panes is Professor of Medicine and the Chief of the Department of Gastroenterology at Hospital Clinic de Barcelona. His research team works on the identification of new molecular targets for the treatment of inflammatory bowel diseases, the development of cell therapies and the implementation of new diagnostic tools, with a particular focus on cross-sectional imaging. Dr. Panes is an expert on performing early- to late-stage clinical trials for new IBD therapeutics. Dr. Panes was President of the European Crohn’s and Colitis Organization (ECCO) and is currently a member of the American Gastroenterology Association (AGA).
AGREED..BUT WORTH GAMBLE SOMETIMES AS ANY GOOD UPDATE IT DOUBLES
It's difficult when these lose $1 per share
ceo is braindead
Str8 trash
CEO's awol
I took my lumps .96
not a peep from the comatose ceo...delisting coming if he doesnt start talking
F*cking garbage.
Balls are getting deflated
Did we find the bottom here??? I’m not one to average down, but might buy another 5k to get me below $1 and see!
Just needs a CEO that understands how to do damage control when his share price falls below $1
just need ceo to address the nasdaq listing imo
Just needs traders with real balls
What are some things coming up that will help the pps?
I took my lumps on this one today at $0.93. Ten thousand shares. If you want to see my trade execution, just let me know and I'll post it here. It's just a pain in the ass to do from the cell phone. But what if the post files you have to use a web browser on your phone then log into ihob and then upload the image, save the image, copy that image URL then paste it. Not sure why they don't just make it easy so you could do this on the app itself
Well that news has been out there for almost a couple months… maybe peeps are realizing the company has no plan to meet the listing requirements and bailing…
Or they see the last P&D was a failure…
DELISTING IS POSSIBLE IS WHY
Not looking like things are going to go our way here, shorts in total control… no mojo left..
Getting Jiggy Here, hope to break a buck soon and maintain pps above $1 as we begin to move north!!
READ THIS GUYS
Nasdaq Deficiency Notice
On November 26, 2021, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market, under Listing Rule 5550(b)(1), because its stockholders’ equity of $(6,969,988) as reported in its Quarterly Report on Form 10-Q for the period ended September 30, 2021 was below the required minimum of $2.5 million, and because, as of November 24, 2021, it did not meet the alternative compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.
On January 10, 2022, the Company submitted to Nasdaq a plan to regain compliance with Listing Rule 5550(b)(1). On February 15, 2022, Nasdaq notified the Company that they have granted the Company an extension of up to 180 calendar days from November 26, 2021, or through May 25, 2022, to regain compliance. If the Company fails to evidence compliance upon filing its periodic report for the quarter ending June 30, 2022, the Company may be subject to delisting. If Nasdaq determines to delist the Company’s common stock, the Company will have the right to appeal to a Nasdaq hearings panel.
Over 30 million shares traded yesterday above $1.20 and today they bring price down below $1.00 and we trade nearly 4M+ so far today below $1.00
Are they covering their shorts or what?!?
Well that sucks, better get another 6 pack
i think i found why the big drop after pump----looks like its being DELISTED :(
whats nasdaq requirements to stay listed?
… let’s go Jack! Slap the shit out of it!
Picked up my blue moon and beginning the weekend early!! $1.00 close coming!!
in the mood to crank up the tunes...
polish up the dance shoes for next week
swingin
cheers
I feel some afternoon Jiggy going to happen today!!! A bit green on 30k holding for at least 50%
Don’t fall for this MM manipulation. Cheapest shares that were purchased by retail on the open market were very minimal below $1.10 yesterday
Over $45,000,000 traded during the day!
So anyone selling now are the GURU followers cause they told you to set Stop Losses below $1.10
Also, we had a good 10K filed yesterday.
That is my opinion. I am holding!
Retail Shorts will have to cover at some point. And cause some buying pressure.
10K was very nice yesterday. I bet some MMs are covering now with all the 6 digit trades.
It could go bonkers next week!
OH WELL...LOST ANOTHER 8GS FOLLOWING A DAYTRADER :(
hope for rebound as shorts cover after this latest low volume attack
Followers
|
25
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
602
|
Created
|
12/23/16
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |