First Wave BioPharma Inc (FWBI)

[TheFinalCD]

.43 priced WARRANTS

$FWBI First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $4.0 Million Gross Proceeds Priced At-the-Market

https://www.globenewswire.com/news-release/2023/09/14/2743459/0/en/First-Wave-BioPharma-Announces-Exercise-of-Warrants-and-Issuance-of-New-Warrants-in-a-Private-Placement-for-4-0-Million-Gross-Proceeds-Priced-At-the-Market.html

[TheFinalCD]

On September 13, 2023, ZyVersa Therapeutics, Inc. (the “Company”) entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with a holder (the “Holder”) of warrants to purchase shares of the Company’s common stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase up to 12,121,213 shares of the Company’s common stock, at a Reduced Exercise Price (as defined below) during the period from September 13, 2023 until 5:30 p.m., Eastern Time, on September 18, 2023 (the “Reduced Price Exercise Period”), in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 12,121,213 shares of the Company’s common stock (the “Inducement Warrant Shares”). Pursuant to the Inducement Letter, upon the exercise of any Existing Warrants, the reduced exercise price for such Existing Warrants during the Reduced Price Exercise Period shall be the lower of (i) the Nasdaq Official Closing Price (as reflected on Nasdaq.com) immediately preceding the day of an exercise of Existing Warrants; or (ii) the average Nasdaq Official Closing Price of the Common Stock (as reflected on Nasdaq.com) for the five (5) Trading Days immediately preceding the day of an exercise of Existing Warrants (the “Reduced Exercise Price”).

[INFINITI]

Out thk you for the 1.07 on to the next GL everyone

[TheFinalCD]

mine was sitting

[subslover]

I had a standing sell order @ $1.01 think I'll go back to bed. :)

[TheFinalCD]

https://dilutiontracker.com/app/search/FWBI

[SILVERSURFER4263]

.88...dilution sux

[TheFinalCD]

1.11 now consolidating under

[INFINITI]

Looks like we breaking paper

[INV4]

Nice news!
$FWBI

[INFINITI]

Let’s break $1

[subslover]

I would love to see this over $1.00 today buddy! :)

[INFINITI]

Load up $$$$

[TheFinalCD]

NOW I LIKE THIS NEWS WITH SANOFI $SNY ($54) https://ih.advfn.com/stock-market/NASDAQ/first-wave-biopharma-FWBI/stock-news/92040537/form-8-k-current-report

https://dilutiontracker.com/app/search/FWBI

[INFINITI]

$1+

[subslover]

First Wave BioPharma Announces Exclusive Global License Agreement for Capeserod from Sanofi
First Wave to develop and repurpose Capeserod for gastrointestinal (GI) indications based on AI-empowered analyses, expanding the company’s GI-focused pipeline
BOCA RATON, Fla., Sept. 14, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced an agreement with Sanofi (NASDAQ: SNY) to license Capeserod, a selective 5-HT4 receptor partial agonist, which First Wave will repurpose and develop for gastrointestinal (GI) indications.

Under the terms of the agreement, First Wave will receive from Sanofi an exclusive, global license for Capeserod and will assume responsibility for all future clinical development. The licensing agreement, which includes a modest upfront payment, backend milestone payments and single digit royalties on net sales, provides a right of first refusal for Sanofi to reacquire Capeserod following certain stages of clinical development and to commercialize the product.

Sanofi’s research on Capeserod and the subsequent artificial intelligence (AI)-empowered analyses suggest that the drug’s mechanism of action has potential applications for several gastrointestinal disorders in multibillion-dollar markets where there are significant unmet clinical needs. Sanofi previously conducted seven Phase 1 and two Phase 2 trials investigating the potential of Capeserod for neurological disorders. In these trials, involving over 600 patients, Capeserod appeared safe and well-tolerated. First Wave will immediately request a meeting with the U.S. Food and Drug Administration (FDA) to establish a development and regulatory pathway for Capeserod in GI diseases with the intent to initiate clinical trials in 2024.

“Securing an exclusive, worldwide license from Sanofi for Capeserod is potentially a transformative event for First Wave that adds a drug with a well-documented safety profile to our GI-focused development pipeline,” stated James Sapirstein, President and CEO of First Wave. “Capeserod has been investigated in multiple clinical trials involving over 600 patients and through this research and AI-based analyses evidence emerged suggesting the drug possesses a unique mechanism of action that is applicable to several GI indications underserved by currently available therapeutics. We intend to immediately initiate discussions with the FDA focused on a development and regulatory plan that would enable us to begin Phase 2 clinical trials of Capeserod in 2024.”

Mr. Sapirstein continued: “First Wave is excited by the opportunity to advance the development of Capeserod in this new indication, and we are supportive of Sanofi’s outlook on AI and its potential to expand the druggable universe, expedite the drug screening process to find disease drivers and potential drug candidates, and lower R&D expenses.”

About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple Phase 2 clinical stage programs built around three proprietary technologies – Capeserod, a selective 5-HT4 receptor partial agonist which First Wave will pursue for gastrointestinal (GI) indications; the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; and niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. First Wave BioPharma

[Awl416]

First Wave BioPharma Announces Exclusive Global License Agreement for Capeserod from Sanofi


Probably see an offering shortly after

[Law of Averages]

Second run starting.$$$$

[SILVERSURFER4263]

.27-.88 wtffffffffffffffffff......damn wall street gets dirtier and dirtier under genslers watch

[SILVERSURFER4263]

why the huge jump today?

[TrendTrade2016]

HERE WE GO...89C NEXT

[TrendTrade2016]

HERE WE GO

[TrendTrade2016]

FWBI...MONSTA...89C

[hondaboost]

FWBI, did many R/S and huge dilutions. LOL! here:

irst 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 diseases, today announced the pricing of a public offering of 3,285,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 6,570,000 shares of its common stock at a combined public offering price $0.64 per share (or pre-funded warrant in lieu thereof) and associated warrants. Each share of common stock (or prefunded warrant in lieu thereof) is being sold together with two warrants, each to purchase one share of common stock.

[SILVERSURFER4263]

after what? 1 or 2 reverse splits--wtf is really going on here? CEO A CROOK

[Monksdream]

FWBI new 52 week low

[Monksdream]

FWBI new 52 week low

[subslover]

NEWS
First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $2.4 Million Gross Proceeds Priced At-the-Market
BOCA RATON, Fla., June 13, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced it has entered into agreements with certain holders of its existing warrants exercisable for 1,681,667 shares of its common stock, in the aggregate, to exercise their warrants at a reduced exercise price of $1.15 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $2.4 million, before deducting financial advisory fees. The reduction in the exercise price of the existing warrants and the issuance of the new warrants was structured as an at-market transaction under Nasdaq rules.

Roth Capital Partners is acting as the Company’s financial advisor for this transaction.

The shares of common stock issuable upon exercise of the warrants are registered pursuant to a registration statement on Form S-1 (File No. 333-267423) which was declared by the Securities and Exchange Commission (SEC) on October 6, 2022 and a registration statement on Form S-3 (File No. 333-268660) which was declared effective by the SEC on December 8, 2022.

In consideration for the immediate exercise of the warrants for cash and the payment of $0.125 per share underlying the new warrants, the exercising holders will receive new warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable into an aggregate of up to 3,363,354 shares of common stock, at an exercise price of $1.15 per share and have a term of exercise equal to five years. The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended, or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-3 with the Securities and Exchange Commission within 10 days of the closing to register the resale of the shares of common stock underlying the new warrants issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

[Invest-in-America]

FWBI: Like I warned earlier, pure FLUFF, baloney-sandwiches, "news". (But, CONGRATS to all here who got it in the PRE-Market --- and then DUMPED it all on any SUCKERS who were dumb enough to buy it AFTER the Open today. GOD-BLESS-AMERICA!!! The Land of Smart People, & Stupid People --- and NOBODY in-between.)

[surf1944]

https://stockcharts.com/h-sc/ui?s=fwbi&p=D&yr=0&mn=6&dy=0&id=p38090673899

https://www.barchart.com/stocks/quotes/fwbi/technical-chart?plot=CANDLE&volume=total&data=DO&density=M&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);ADX(14);SMA(50);SMACD(12,26,9);RSI(14,100);ACCUM;STOSL(14,3)&sym=CNNA&grid=1&height=500&studyheight=100

https://www.barchart.com/stocks/quotes/fwbi/technical-chart?plot=CANDLE&volume=total&data=DO&density=ML&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;SMA(20);SMA(50);SMA(100);SMA(200);CHKMF(20)&sym=SYSX&grid=1&height=210&studyheight=100

https://www.barchart.com/stocks/quotes/fwbi/opinion

https://finance.yahoo.com/quote/fwbi/

[Invest-in-America]

FWBI: I can NOT do that, over here on the WEST coast, Boss! Humans DO have to SLEEP, once in awhile! (I know, "The Early Bird Gets The Worm"!!)



PS: Anyway, I'm about to SCORE HUGELY, over on my @OLB --- which, by the way, was YOUR pick!!! (THANKS!!!)

[subslover]

Not if you got in at 1.66 pre market :)

[Invest-in-America]

FWBI: Pure FLUFF "news", if there ever was any!!

[Invest-in-America]

FWBI: Sucker's Bait morning gapper!!!

[TheFinalCD]

its a mover...

i got some 2.30 after the 2.64 top

[TheFinalCD]

YEP WILD, ENROLLMENT FILLED AND +111%

https://finance.yahoo.com/news/first-wave-biopharma-reaches-enrollment-110000252.html

there was a time when this might see 11% if lucky more like 1.1% on news like this

welcome to stock runs 2023

where anything and everything goes

[Awl416]

Wild

[subslover]

Starting to run fast! Check it out = There were 1,813,663 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of May 10, 2023.

[subslover]

First Wave BioPharma Reaches Enrollment Target for Phase 2 SPAN Adrulipase Clinical Trial in Cystic Fibrosis
Two-thirds of patients have completed study, final patients being dosed
Top line data read-out on track for July 2023
BOCA RATON, Fla., June 13, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has achieved the enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

The Phase 2 multi-center clinical trial (NCT05719311) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Topline results from the study are anticipated by mid-2023.

James Sapirstein, Chief Executive Officer of First Wave BioPharma commented, “We are very pleased to have reached the enrollment target in our Phase 2b SPAN study of adrulipase. The majority of patients in the study have completed dosing and the remaining patients are currently being dosed. We remain on track to report topline data in July 2023”.

Phase 2 SPAN Trial Design
The Phase 2b SPAN trial is designed to investigate the safety, tolerability, and efficacy of a new enteric microgranulation formulation of adrulipase. The SPAN trial is an open-label study that will be conducted at three sites in the U.S. A total of 13 cystic fibrosis patients, all 18 years or older have been enrolled. The trial design employs a dose titration strategy. Patients will be screened at baseline to ensure that they have a coefficient of fat absorption (CFA) of at least 80%. Eligible patients will then be switched from their commercial enzyme product to adrulipase. Each patient will be started on a low dose of adrulipase. If the patient is not clinically controlled, the patient will be switched to a medium dose, and if not controlled on this dose, the patient will be advanced to a high dose. The titrations will be carried out over a three-week period, after which a CFA will be obtained. End-of-study CFAs will be compared to the baseline CFAs in a descriptive fashion. A post-treatment safety visit will be conducted one week after completing the treatment period.

About Adrulipase
Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge, and weight loss. There are approximately 40,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 95,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.

About First Wave BioPharma, Inc.
First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple clinical stage programs built around its two proprietary technologies – the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients, and niclosamide, an oral small molecule with anti-inflammatory properties. First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). In developing adrulipase, First Wave is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived and offers the potential to dramatically reduce their daily pill burden. The company is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
First Wave BioPharma, Inc.
777 Yamato Road, Suite 502
Boca Raton, FL 33431
Phone: [phone]
[e-mail]
[e-mail]

https://www.globenewswire.com/newsroom/ti?nf=ODg1Njk4MyM1NjQzMTEzIzIwODIyMDc=
https://ml.globenewswire.com/media/NGI1ZTg1OTktNDAwZS00ZGE2LTlkOTMtZjE2NDM1YTlkYmQwLTEwOTM3Nzg=/tiny/First-Wave-BioPharma-Inc-.png

Source: First Wave BioPharma, Inc.
© 2023 GlobeNewswire, Inc.

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[Awl416]

First Wave BioPharma Reaches Enrollment Target for Phase 2 SPAN Adrulipase Clinical Trial in Cystic Fibrosis

[starkd748]

Closed out today

[starkd748]

Look now

[starkd748]

Yeeeehaw

[starkd748]

Yup I thought it will double bottom at 2.97... stochastic was near 0 all last week

[stock1ace1]

$4.26

[starkd748]

2.97 might be a buy or further collaspe

[starkd748]

Weekly chart shows no demand bearish divergence....I'll buy will 5he weekly psar crosses over

[stock1ace1]

News Out *** -> First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

[stock1ace1]

995k o/s — 869k float listed on webull

[stock1ace1]

Double bottom intraday 6 red days bounce watch