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Volume presently over 2 million!
RedHill Biopharma Releases Data on Opaganib:
https://finance.yahoo.com/news/biotech-stock-roundup-regn-gives-144402274.html
RedHill Biopharma RDHL announced positive preliminary results from a new preclinical study on opaganib. The candidate was studied in a 3D tissue model of human bronchial epithelial cells to evaluate the in vitro efficacy of opaganib in inhibiting the Delta variant. Opaganib demonstrated strong inhibition of COVID-19 Delta variant in a human bronchial epithelial cells model, adding to prior data demonstrating potent inhibition of all COVID-19 variants tested to date. The global 475-patient phase II/III study with opaganib oral pill in hospitalized COVID-19 patients has completed treatment and follow up phase, with top-line results expected shortly.
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10.25+0.15 (+1.49%)
As of 2:31PM EDT. Market open.
Volume 1,746,709
Avg. Volume 507,150
With 1 hour 30 minutes to go, volume
sure has gone up substantially. (and
as of yet with no news)
Covid Oral therapeutic
MRK - started P3 trial
PFE - started 2nd Oral pill P3 started
RDHL - P2 results awaited
MRK will charge approx $700 per course if 10 pills. So it is not cheap.
For RDHL - the competition is tough and is with BP - so they need to get very good results so some BP does collaboration - JnJ, AZN are prime candidates as they have vaccines so they are vaccine players and would like to have a pill in the Arsenal.
————————-
Sept 1 (Reuters) - Merck & Co Inc and partner Ridgeback Biotherapeutics said on Wednesday they had begun enrolling patients in a late-stage trial of their experimental drug molnupiravir for prevention of COVID-19 infection.
Merck said in June the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in a separate, ongoing large trial and authorized by U.S. regulators.
I have, among others, a Google alert
RDHL, and already a few days i receive
numerous same news but in different
languages: French, Italian, German,
Japanese, Chinese and two unrecognisable
languages too.
The meaning is that RDHL enjoyed much
more worldwide exposure, hence the huge
volume surge.
Why RedHill Biopharma Stock Jumped on Tuesday
https://www.fool.com/investing/2021/08/31/why-redhill-biopharma-stock-jumped-on-tuesday/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
An analyst on Wall Street thinks the company's commercial and development pipeline has been underestimated.
Cory Renauer
(TMFang4apples)
Aug 31, 2021 at 4:11PM
RedHill Biopharma has more drugs on the market and in clinical trials than you'd expect for a stock with such a low market valuation.
What happened
Shares of RedHill Biopharma (NASDAQ:RDHL) are on the move after Cantor Fitzgerald initiated coverage of the biopharmaceutical company. Investors excited about the buy rating have pushed the stock 20.3% higher as of 3:15 p.m. EDT on Tuesday.
So what
RedHill Biopharma has three drugs on the market and six in clinical trials right now. With so much under the hood, it's no wonder analysts think it's a bargain at its ultralow valuation. Yesterday this company had a market cap of around $360 million.
Early last year the company began marketing Talicia for the treatment of Helicobacter pylori infections in adults. Roughly one-third of people get an H. pylori infection at some point in their life. While they usually clear up without lingering issues, these infections can cause peptic ulcers and increase the risk of stomach cancer.
The company is also developing opaganib, a novel sphingosine kinase inhibitor, as a potential stomach cancer treatment. Opaganib is in a phase 2 oncology trial at the moment, plus enrollment in a phase 2/3 study has been completed for its use in treatment of COVID-19.
Now what
Sales of RedHill's commercial-stage drugs aren't exactly amazing. Despite it being in the middle of multiple new drug launches, top-line revenue during the second quarter came in at a measly $21.5 million, which was only about $600,000 more than the company reported in the previous-year period.
Multibillion-dollar valuations aren't uncommon for companies that have zero commercial-stage products, so it's not hard to see why Cantor Fitzgerald thinks this stock is undervalued. The important thing for individual investors to understand is that the stock only appears undervalued on a risk-adjusted basis. While eventual approval of its clinical-stage drugs could propel the stock many times higher, there's still a lot that could go wrong and result in irrecoverable losses.
At least it defended an increase of $1.50+
17% - that is big
RedHill Biopharma initiated overweight at Cantor citing COVID-19 prospects
Aug. 31, 2021 1:08 PM ET RedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
Extending the rally into the fourth straight session, RedHill Biopharma (NASDAQ:RDHL) is set to post its second consecutive double-digit gain in percentage terms today after Cantor Fitzgerald initiated its coverage with an overweight rating.
On Monday, RedHill Biopharma (RDHL) reported positive Phase 2 data for the company’s experimental COVID-19 therapy Opaganib indicating that patients who received the oral therapy required less oxygen and were discharged earlier from the hospital compared to the placebo.
Cantor analyst, Brandon Folkes, identifies the company’s portfolio as “broad, deep and robust,” with two potential COVID-19 therapeutics.
In addition, RedHill Biopharma’s (RDHL) commercial portfolio, “provides investors with a compelling investment opportunity given significant potential upside from current levels, even if only one or two projects from its pipeline are successful,” Folkes argued.
Cantor sets a $22 per share price target on the company to imply a premium of ~156.1% to the last close.
In addition to Opaganib, RedHill Biopharma (RDHL) is advancing its oral anti-viral RHB-107 (upamostat) in a Phase 2/3 study targeting symptomatic COVID-19 in non-hospitalized patients who don’t require supplemental oxygen.
Seems to me many day traders are involved
with the buying and selling. hence the
HUGE robust volume.
I may assume that even longs were tempted
to sell some of their 'trading' shares
while keeping their hard core shares with
a lower price or even 'free' shares.
All in all it is a well balanced equilibrium
between Fear vs Greed!
Anyway, with ~20% increase with no news,
only expectations it is an awesome increase!
With 8 million traded why are we only at a little over $10?
With this 20 fold times average volume
it would be hard to make an educated
guestimate. Still i would say $10.50
will be quite close at EOD.
Wow! Wow! Wow!
The volume is 7.2 million...and it's only 11:03 A.M.
As expected started downward movement
Hopefully it keeps at least $1 gain by EOD
This is the reason - the price target is $22
That makes RDHL a Billion dollar company - if it becomes Covid play - it is under-estimate.
2021-08-31 10:59:00 GMT DJ RedHill Biopharma Price Target Announced at $22.00/Share by Cantor Fitzgerald
10.21+1.62 (+18.86%)
As of 9:41AM EDT. Market open.
Volume 1,055,529
Avg. Volume 360,979
WOW!!!
Let’s hope this does not falter like before.
The stock is showing moves as if it a Covid stock. With new variants reducing efficacy of vaccines - a combo of vaccine to reduce hospitalization cases and therapeutic to reduce hospitalization stay and reduce deaths will be long term approach.
The SP increase is showing excitement and hope that OPA will give good results in 475 patients. If the results are good, it is direct challenge to Regereon antibodies. They cost some $1000 per dose and infusion etc - A pill will be very convenient and it will be a big deal.
Even after this increase, the market cap is just $ 400 million - that reflects old valuation - once this is declared a Covid play - it has to go into billion dollar plus market cap - which is 2.5 times from here.
Let’s hope this does not falter like before.
Redhill's opaganib found effective in phase 2 study for COVID-19 pneumonia
Aug. 30, 2021 3:53 PM ETRedHill Biopharma Ltd. (RDHL)By: Jonathan M Block, SA News Editor1 Comment
Opaganib from Redhill Biopharma (RDHL +10.1%) led to patients with COVID-19 pneumonia requiring less oxygen and earlier hospital discharge compared to those on placebo, according to a phase 2 study.
Results, published as a preprint in medRxiv, found that by day 14, 50% of opaganib patients didn't require supplemental oxygen, while 22.2% did not. The relative decrease in total supplemental oxygen requirement from baseline to day 14 was 61.6% in the opaganib vs. 46.7% in the placebo arms.
As a preprint, the data has not yet been subjected to peer review.
The rate of at least grade 3 treatment-emergent adverse events was 17.4% and 33.3% in the opaganib and placebo groups, respectively.
A total of 42 patients were enrolled. Three patients died in each arm.
Last week, Redhill posted quarterly revenue that increased 3% year-over-year.
Read Next: RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q2 2021 Results - Earnings Call Transcript
Absolutely!
8.18+0.42 (+5.37%)
As of 12:06PM EDT. Market open.
Volume 631,825
Avg. Volume 343,282
Nice! Very Nice!!
Yes and then the 2nd pill for non-hospitalized patients
Rather than approval - SP will go up on trial results if good - it will turn into a Covid play
There are some additional irons in
the fire:
Like MDWD - Barda purchses its products
a long time before FDA approval.
(BARDA Upsizes Support for NexoBrid with an Additional $21 Million to Fund Continuous Access Treatment Protocol for Thermal Burn
https://ir.mediwound.com/news-releases/news-release-details/barda-upsizes-support-nexobrid-additional-21-million-fund
Aemcolo® Still has a lot of $$$ potential.
To name just a few, but of course Opaganib is the most
relevant item on the agenda, especially should the news
be good, an a BP partnership on the pill which could
have many nany million $$$ upfront IF..........
That is right but it is a stagnant product and it’s sale will remain in this range most of the life
At this time - it is good product for RDHL to make money to support sales staff but it can never help to get the SP up
Methinks that with eventual good news
in regards Opaganib, it would be a
good opportunity to reduce holdings
or get rid of it all.
Myself, i will probably reduce my
holdings by 30-40% following the
price bump (assuming it increases
by at least 80% at the announcement)
AEMCOLO® Produced by Cosmo:
Home /Products / AEMCOLO®
Aemcolo® is a pharmaceutical drug product containing rifamycin SV formulated with the MMX® technology. Aemcolo® contains a broad spectrum, semi-synthetic, orally non-absorbable antibiotic, and has been approved in the US and in the EU for the treatment of traveler’s diarrhea caused by non-invasive E. coli strains. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo® tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus avoiding its systemic absorption in the small intestine.
Aemcolo® is the first FDA approved antibiotic for the treatment of travelers’ diarrhea in over a decade and is now marketed by RedHill Biopharma in US.
In addition, Dr. Falk Pharma, our licensee, has received approval in EU through the European Decentralized Procedure (DCP) for Relafalk for the treatment of travelers’ diarrhea. In a phase 3 clinical study against ciprofloxacin in traveler’s diarrhea, patients treated with ciprofloxacin had a significant increase in the colonization rate by Extended Spectrum ß-Lactamase-producing (ESBL) Escherichia Coli, whereas patients treated with Aemcolo® were not. Extended-spectrum beta-lactamases (ESBL) are enzymes that confer resistance to most beta-lactam antibiotics, including penicillins, cephalosporins, and the monobactam aztreonam, also including many fourth generation cephalosporins. This provides an important advantage in view of the recent concerns regarding the emergence of multi-drug resistant bacteria, whose infections are challenging to be treated.
COMPANY
Cosmo is a specialty pharmaceutical company with a focus on gastroenterology and endoscopy.
We develop and manufacture products which are distributed globally.
https://www.cosmopharma.com/
RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals
28 January, 2021
New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains
TEL AVIV, Israel and RALEIGH, NC, January 28, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640)1, to address prospective demand subsequent to potential global emergency use authorizations.
“The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics.” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo’s quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. By targeting SK2, a human cell component involved in viral replication irrespective of mutations in the viral Spike protein, opaganib potentially addresses the emergence of new strains.”
“We are delighted to further strengthen our partnership with RedHill on expanded opaganib manufacturing, and to play a part in trying to help alleviate the suffering the coronavirus pandemic is causing across the world, should opaganib be approved for use,” said Davide Malavasi, Cosmo’s Head of Manufacturing.
https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=4457&PID=0&IID=19325
Movantik is not a growth market drug, never made money and the reason it was jettisoned was because of far sighted AZ management wanted to limit any liability with opioid interactions. That market will never grow under the current circumstances.
BEEN trying to find the names of the companies that rdhl is using to make the pills. only found one name. COSMO. not a USA company. will give a call tomorrow to see if they are already making it. would be nice if we could find out the names of the american companies they have.
From yahoo mb- a very negative post but a lot of truth
—-/
Opmints don't work for a virus like Sars-Co-V-2 in VIVO.
Sales plan for buildout and Talicia rollout is kaput.
Too many chiefs and way too many Indians.
Upromissthat and cell phones is lunacy hype in a pandemic.
Aemcolo has a very narrow range of indications which don't compete well against a multitude of other drugs namely against Salix's.
Movantik is not a growth market drug, never made money and the reason it was jettisoned was because of far sighted AZ management wanted to limit any liability with opioid interactions. That market will never grow under the current circumstances.
DBA et.al. have granted themselves very lucrative option packages which they sold to insiders for cash and dilution ($1.8 million last round)
Speaking of dilution have you seen the last 3? The next round of stock has 200,000,000 shares lined up waiting to soak the market for cash and a real decline.
Ownership of ~1/3 of outstanding stock is tied to A: Cosmo B: Frank Vasile Timis. When you get done explaining the Cosmo structure of corporate ownership, get back to me with the pros. vs the cons.
It has nothing to do with pills vs. injections or topical steroids like PreparationH. It's the science no. 1. and the lack of execution in the business plan they set up 5 years ago (gastro) 2.
Take into consideration the shady ownership 3. and the ties to the low level managers in place 4. it's no wonder these continual missteps keep occurring causing them to go back into the market for more cash. 5
And the most revealing answer is the lack of transparency in all of this. Crohn's RHB-104 shelved now revisited. Talicia trumpeted now back burner. Bekinda, jettisoned. etc. They dive in with great PR, fanfare, eye popping announcements of potential and then fade away into oblivion.
An occasional patent file or regurgitation of the old press releases is now all you get.
So what's not to like! eh?
U-19
New video on proactive - not good sign
Most proactive bideos are by companies trying to do promotion and they go down -
WHY-HAVE-THEY-NOT-GIVEN-MONEY-TO-COMPANIES-TRYING TO COME-UP-WITH-THESE MEDS TO CURE THIS.. HE-GIVES-BILLIONS-TO-PEOPLE-NOT-TO-WORK-WHY-NOT-GIVE-BILLIONS-FOR-COMPANIES-TO-USE-TO-USE-TO-COME-UP-WITH-MEDS-TO-CURE-PEOPLE-OF-THIS.
got-to-ask-why-the-biden-assholes-do-not-talk-about-meds-that-can-treat-covid.
ANOTHER DAY OF DILUTION. TOTAL ASSHOLES.
I think I will most likely make profit
on this stock by end of the year
The OPA results is a key milestone
REGN antibody combo was bought by US Govt @ $2000 per dose.
OPA is a pill and no IV etc - so if effective in this study - you can imagine the price jump. The current market cap is just $ 335 Million - on that single drug- this can jump to $1 B plus.
I like today’s call - I am in strong red but I think I will most likely make profit on this stock by end of the year
“Regeneron fulfilled its second agreement with the U.S. government in the second quarter to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the FDA, and recognized $2.59 billion in REGEN-COV sales.”
THIS -IS-INSANE-ANOTHER-TRIAL.-2-PHASE-2-TRIAS-THAT-PROVED-SAFETY.-IF-IT-WORKS-IT WORKS. THIS IS THE BIDEN OBAMA FDA. TAKE 2 YEARS FOR A MED TO SAVE PEOPLE DURING A PANDAMIC TO GET APPROVED. TOTAL FING ASSHOLES. AND JUST TO SAY THESE FING PEOPLE RUNNING THIS COMPANY AND FING DILUTING 4 TIMES DURING THIS PROCEDURE ARE TOTAL SCUMBAGS. ONE OF THE REASONS I BOUGHT THIS STOCK WAS BECAUSE OF THE LOW SHARE COUNT. I GOT FUKED.
That is helpful. And then just a couple of quick clarification questions on the opaganib program in -- Dror, I don't know if you want to answer this or not, but I mean you've used words like shortly and upcoming for the data presentation. I'm not going to pin you down, but would you expect that data by the end of September, by the end of the third quarter? I mean, that would typically be a safe assumption, but I thought I'd give you a chance to confirm that.
Dror Ben-Asher
Yes, absolutely. There's nobody that wants to announce the data more than the team here with us right here. So we will make sure that the upcoming results reach the market as soon as possible. And yes, to answer your question, certainly, before the date that you mentioned.
RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q2 2021 Results - Earnings Call Transcript
Aug. 26, 2021 1:07 PM ETRedHill Biopharma Ltd. (RDHL), REDIF
RedHill Biopharma Ltd. (NASDAQ:RDHL) Q2 2021 Earnings Conference Call August 26, 2021 8:30 AM ET
Company Participants
Alexandra Okmian - Senior Business Development and Investor Relations Manager
Dror Ben-Asher - Chief Executive Officer
Guy Goldberg - Chief Business Officer
Gilead Raday - Chief Operating Officer
Rob Jackson - Senior Vice President, Sales and Marketing
Micha Ben-Chorin - Chief Financial Officer
Rick Scruggs - Chief Commercial Officer
Adi Frish - Chief Corporate and Business Development Officer
Bob Gilkin - Senior Vice President, Market Access and Trade Relations
Conference Call Participants
Boobalan Pachaiyappan - H.C. Wainwright
Robert Hazlett - BTIG
David Hoang - SMBC
Matthew Kaplan - Ladenburg Thalmann
Scott Henry - ROTH Capital Partners
Operator
Good day, and welcome to the RedHill Biopharma Second Quarter 2021 Financial Results Conference Call. [Operator Instructions]
At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Micha Ben-Chorin, Chief Financial Officer; Rick Scruggs, Chief Commercial Officer; Gilead Raday, Chief Operating Officer; Guy Goldberg, Chief Business Officer; Adi Frish, Chief Corporate and Business Development Officer; Rob Jackson, Senior Vice President, Sales and Marketing; and Bob Gilkin, Senior VP, Market Access and Trade Relations.
Before we begin, we will read from the RedHill's safe harbor statement. Please go ahead.
Alexandra Okmian
Thank you, Andrea. This conference call may contain projections or other forward-looking statements regarding future events or the future performance of RedHill, including statements with respect to the business promotion and other efforts related to RedHill's commercialization activities and the initiation, timing, progress and results of RedHill's research, manufacturing, preclinical studies, clinical trials, marketing applications and approvals, if any, including the clinical trials of opaganib and RHB-107 for the treatment of COVID-19.
These statements are only predictions and RedHill cannot guarantee that they will, in fact, occur. RedHill does not assume any obligation to update that information. Actual events, performance, timing, results or commercialization activities may differ materially from what RedHill projects today. Additional information concerning factors that could cause actual events, performance, timing, results or commercialization activities to materially differ from those contained in the forward-looking statements can be found in the company's annual report on Form 20-F filed with the SEC on March 18, 2021, and in its other filings with the Securities and Exchange Commission.
I will now transfer the call to Dror Ben-Asher, RedHill's CEO.
Dror Ben-Asher
Thank you, Alexandra. Good day, everyone, and thank you for joining our second quarter earnings call. We hope that this call finds you and your loved ones safe and well despite the challenging times.
Today, we will be presenting detailed R&D, commercial and financial highlights. Starting with R&D. COVID-19 is a devastating disease. Delta and other variants of concern continue to rapidly spread havoc across the U.S. and the globe. Along with rising COVID-19 new cases hospitalizations and, unfortunately, death, there's a clear and immediate need for an effective COVID-19 therapeutic in an oral pill form, as outlined by many public health experts, including recently by the Director of the NIH.
I'm proud of RedHill's small but agile and resilient team that rose to the challenge and remain relentlessly execution-focused.
This morning, we announced data from the University of Louisville showing strong inhibition of the Delta variant with opaganib. Also this morning, we announced important potential support by Quantum Leap and BARDA, an arm of the U.S. government, for opaganib to be included in the I-SPY COVID-19 clinical trial as a promising drug candidate for severe COVID-19 patients.
In parallel, our team and our partners are doing everything humanly possible to get to the finish line with opaganib's global 475 patient Phase 2/3 study in severe COVID-19. With last patient out announced last month, we are nearly there. Remarkably, this study only commenced about a year ago. It was planned and executed by RedHill and its partners at the speed of light, in pharma terms, and it was driven by the urgent medical need all around. To put things in perspective, opaganib is probably the most advanced novel dual mode of action, oral pill candidate of its kind in development currently for hospitalized COVID-19 patients.
Opaganib demonstrates strong antiviral activity, including key variants of concerns such as Delta, and as well as strong anti-inflammatory activity, including very recently data about Interleukin-6, IL-6 inhibition. This is an important inflammatory cytokine target highly relevant for COVID-19 disease. From an even broader perspective, it is important to note that fighting viruses that lead to devastating epidemics or pandemics, in a globalized and interconnected world, does not stop with COVID-19. Opaganib's potential goes way beyond COVID-19, and it is therefore being explored in additional infectious diseases and models such as Ebola and other.
A lot more is happening here at RedHill on the R&D front. For example, this morning, we reported that the primary endpoint was met in the ongoing Phase 2 study of opaganib in prostate cancer based on our preliminary review. Our second COVID-19 drug candidate, the antiviral and once-daily oral drug RHB-107 or upamostat, continues its Phase 2/3 study in non-hospitalized COVID-19 patients early in the course of the disease.
For RHB-204, the Phase 3 study in the U.S. for NTM infection is also ongoing. Our Chief Operating Officer, Gilead, will add more color about select R&D programs shortly.
Moving on to the commercial front. Earlier today, we announced the achievement of record quarterly revenues despite the challenging pandemic environment, particularly so for new drug launches such as Talicia. Talicia prescription volume continues to grow and new prescription growth from Movantik during the quarter has been strong, even beating pre-pandemic levels.
New formulary wins with several of the nation's largest payors translate into an impressive 8 out of 10 commercially insured Americans now being covered for Talicia and 9 out of 10 commercially insured Americans now being covered for Movantik. Plans are also in place to build on the initial momentum that Aemcolo was generating pre-COVID travel restriction.
Rob, our Head of Sales and Marketing, will provide additional details in a moment.
I will now turn to our Chief Business Officer, Guy and the rest of the team, for a presentation to be followed by a Q&A session.
Guy Goldberg
Thank you, Dror. As we conclude the first half of the year, RedHill is at a very exciting point. Top line results are expected shortly from our opaganib global Phase 2/3 study in hospitalized COVID patients and this could potentially be a transformative event for the company. As we all know, the dream that vaccines alone will get us out of this pandemic will most likely not become reality. This is why public health officials have been saying that a simple, scalable, effective and safe therapeutic is the key to return to normalcy.
RedHill foresaw this need from day 1 of the pandemic and has worked diligently to complete several nonclinical and clinical studies to bring us to the point where we are today. And this is why our announcements this morning are so important and so exciting. First, we announced positive preclinical data of opaganib in the Delta variant. This is important because the Delta variant is currently the predominant strain of the virus in the United States and elsewhere. The Delta variant is highly contagious, more than 2x as contagious as previous variants. Some data suggests that Delta variant might cause more severe illness than previous strains in unvaccinated persons. Having a drug that may work specifically against the Delta variant would be a major breakthrough.
Second, we are in the final stages of selection by Quantum Leap Healthcare Collaborative and BARDA for inclusion in I-SPY COVID-19 platform. The I-SPY COVID trial is designed to rapidly screen and confirm high-impact treatments to reduce mortality and time on ventilators. Opaganib's inclusion is very important for 2 reasons: First, this is a great validation for our science. And second, this is a great platform to test opaganib against other leading candidates out there utilizing existing clinical trial infrastructure. There have been very few, if any, breakthroughs on the treatment front and many failures to date. There have been no novel oral therapeutics developed successfully. And as we are all beginning to accept even with the most optimistic and aggressive vaccination scenarios, COVID is likely to be an endemic global health problem, which will be around for a long time. There is an acute need for effective treatment, especially given the growing concerns around mutations.
Third and finally, we announced, and this is not COVID related, that we met the primary endpoint in an ongoing prostate cancer Phase 2 study of opaganib in combination with androgen inhibitors based on the preliminary review of the data. Opaganib was originally developed as an oncology agent well before COVID, and these results show that it continues to be a promising agent targeting multiple indications, and we will continue to develop opaganib where it holds the most promise.
I would like to briefly provide an overview of RedHill to those new to the story who may be on the call today. RedHill is the fully integrated specialty biopharmaceutical company focused on gastrointestinal and infectious diseases with a robust pipeline of drugs in a world-class commercial operation run out of our U.S. headquarters in Raleigh, North Carolina. At the top of the slide, you see the 3 FDA-approved drugs we promote: Movantik for opioid-induced constipation, Talicia for H. pylori infection, and Aemcolo for travelers' diarrhea caused by noninvasive strains of E. coli. Rob Jackson, our Senior Vice President for Marketing, Sales, will go into detail on our commercial efforts.
The second part of this slide shows the multiple late-stage programs in development, addressing important unmet medical needs. Gilead Raday, our Chief Operating Officer, will review our COVID programs in RHB-204. So I will briefly update where we are with our other programs, notably RHB-104 for Crohn's disease. As a reminder, RHB-104 for Crohn's builds on the growing evidence from the various studies that intracellular microbacteria play a crucial role in Crohn's disease. Testing this theory, we conducted a Phase 3 study in Crohn's disease that successfully met our primary and key secondary endpoints. We continue to advance the program in various ways and hope to have some news later this year.
Right now, given the intense effort we are making as a small company to fight this pandemic, our R&D efforts are focused on running COVID studies in parallel with opaganib and RHB-107, and we are also focused on RHB-204 for NTM disease as there's nothing approved first line, and we could be the first.
This slide highlights our progress since our last earnings call. On the commercial side, we generated record quarterly revenues despite industry-wide challenges, and we believe we will see growth throughout the second half of the year. As a small company with a relatively new commercial operation, we continue to stand the test of the pandemic and prove we are a resilient organization.
Talicia generated over 10% quarter-over-quarter growth, commercial coverage continues to improve and now covers 8 out of 10 lives. We continue to achieve important launch milestones. We believe Talicia has enormous potential both for patients and as a value driver for RedHill as a company. As with almost all launches, especially during these challenging times, we continue to advise that it takes time to build awareness and acceptance, both with payors and also with physicians.
With Movantik, we grew over 5% in the second quarter, which is impressive for an established market leader in a relatively consistent PAMORA market. Movantik is well liked by physicians. It has great reimbursement, great efficacy and safety and great brand recognition and satisfaction. We continue to protect our leadership position in the PAMORA space and we believe we will see a great second half of the year. There's still a very large and underserved OIC patient population, and RedHill continues to improve Movantik's status of best unrestricted coverage in the PAMORA class.
We maintained a comfortable cash position of approximately $71.5 million as of June 30 to support our R&D and commercial efforts. On the R&D side, we are laser-focused on our opaganib Phase 2/3 results. We announced on July 19 last patient out and then follows a process that involves collecting, cleaning, unlocking the database and then analyzing data from the various sites worldwide. When we announced top line results, we plan on announcing efficacy and safety endpoints, including primary endpoint and secondary endpoint covering clinical improvement measures such as reaching air oxygen and time to hospital discharge and incidents of intubation and mortality.
We are also progressing RHB-107, our second COVID program, which addresses the non-hospitalized, symptomatic patient population at early stage of disease and are planning to expand that study outside the U.S. Another central program for us is our ongoing study for RHB-204 for NTM disease, an important indication with no approved first-time standalone treatment. RHB-204 could be the first drug approved to treat this important orphan disease. We have begun enrolling patients, though it is still early going. Clinical activity for pulmonologists has been affected by COVID and continues to be and certainly so for respiratory studies.
This slide shows our vision to become a leading specialty pharmaceutical company. The key to success is to grow both organically and inorganically by developing drugs in-house and also opportunistically bringing in commercial stage products from other companies. We've been successful so far with this approach as we acquired Movantik from AstraZeneca and also when we developed Talicia all the way through 2 clinical studies, approval and launch. We will continue with that strategy into the future.
I will now turn the presentation over to Gilead to discuss our R&D in more detail.
Gilead Raday
Thank you, Guy. I'm pleased to provide an overview of RedHill's R&D progress.
COVID-19 has been a major R&D focus for RedHill in Q2 and continues to be so going into Q3. The latest pandemic waves in countries with a high proportion of their population vaccinated are challenging the sufficiency of vaccines for keeping the pandemic at bay. Health agencies are now looking to oral antiviral therapies as the next step, and the U.S. government is now directing billions of dollars to support development of an effective oral pill therapy, which is our current holy grail. To illustrate where the COVID-19 field is currently, here are 2 quotes from a recent interview with Dr. Anthony Fauci on August 3. The first quote reads, "While vaccines, including boosters, remain vitally important, we increasingly recognize the therapies safe, effective, scalable, affordable are no less essential to any lasting solutions to the pandemic." When asked about the ideal COVID therapeutic drug profile, Dr. Fauci replied, "Already administered single pill given for 7 to 10 days, little drug-drug interaction and low toxicity. Give me that, and I'll be really happy." Remarkably, both of RedHill's therapeutic candidates, opaganib and upamostat, come as close as it gets to this ideal drug profile.
With that, RedHill is currently developing 2 leading candidates that are positioned at the forefront of this high-priority category of potential game-changing COVID-19 therapies. Opaganib, which is our first advanced oral pill therapeutic candidate for COVID-19, is in an exciting phase. Our global Phase 2/3 study of 475 severe COVID-19 patients has completed the enrollment, treatment and follow-up stages and the much anticipated top line results are just around the corner.
Opaganib is a first-in-class inhibitor of SK2, which is an intracellular human enzyme with distinct functions, spanning regulation of transcription, proliferation and inflammation. Opaganib acts against COVID-19 dually. On the one hand, it suppresses the viral replication, and on the other hand, it reduces the tissue damaging excess inflammation, which is caused by the viral infection. Importantly, by targeting a human host cell factor, opaganib upholds its antiviral activity against the emerging variants of concern, independently of the spike protein mutations. In particular, new data reported earlier today demonstrated the potent activity of opaganib against the worrisome and highly infective Delta variant. This is a highly encouraging outcome, which supports the proposition of a potential long-term and enduring benefit of opaganib even as situated against continuously emerging variants of concern.
As an oral pill, opaganib has clear and important advantages in terms of its ease of distribution and administration. Coupled with its good safety profile, opaganib is very closely aligned with the ideal COVID-19 drug profile as was recently defined by Dr. Fauci, and could potentially treat a very broad range of COVID-19 patients from the mild outpatients to the severe hospitalized patients.
Given the broad utilization of opaganib, we have embarked on setting up a robust supply chain for its scaled up manufacturing. As previously mentioned, the global Phase 2/3 study has completed follow-up of all study subjects and top line readout is upcoming.
To recap, this slide shows the encouraging milestones already obtained with opaganib, which underlie its promising potential efficacy, safety and enduring benefit against the variants of concern. Opaganib successfully completed a randomized controlled Phase 2 study in the U.S. in 40 patients, which demonstrated positive safety and efficacy signals. These outcomes serve to align the powering of the global Phase 2/3 study that we are now anticipating the results of.
Opaganib safety database is growing quickly. The ongoing global Phase 2/3 study has passed 4 independent safety monitoring reviews of unblinded data. We also obtained positive compassionate use experience with opaganib from Israel and Switzerland. Recently, opaganib was selected by Quantum Leap Healthcare and BARDA for BARDA-funded inclusion in the I-SPY COVID-19 platform trial. Execution of the opaganib arm is subject to FDA approval.
As announced earlier today, opaganib showed strong inhibition of the Delta variant of concern in a preclinical model of the disease, in human lung bronchial tissue. This excellent outcome further supports the proposition that opaganib's antiviral activity is maintained irrespective of worrisome mutations in the spike protein that may create resistance to deployed vaccines and antibodies.
As previously reported and illustrated in the figures at the bottom of this slide, opaganib compared favorably with remdesivir in inhibiting the replication of SARS CoV-2 Washington strain, while preserving cell viability. At the same time, opaganib also demonstrated a marked reduction in the levels of IL-6 in the infected lung tissue, again, supporting its combined anti-inflammatory and antiviral dual action. These accumulated achievements and others not detailed on this slide illustrate the promising profile of opaganib as a potential ideal COVID-19 therapeutic, underlying the hopes and expectations from the program now advancing toward top line data readout from the global Phase 2/3 study.
To recap highlights of clinical outcomes to date, opaganib showed encouraging results from the successfully completed randomized, double-blind, placebo-controlled Phase 2 study in hospitalized patients with severe COVID-19. The study's patients required supplemental oxygen supported baseline, corresponding to Levels 4 and 5 on the WHO ordinal scale of disease severity. Opaganib showed a benefit in reducing the need for supplemental oxygen on top of standard of care. Specifically, a greater proportion of patients treated with opaganib no longer required supplemental oxygen by day 14, 50% versus 22% in the control arm, respectively.
Opaganib also showed a benefit in time to discharge from hospital. And in terms of safety, opaganib was overall safe and well tolerated.
For a few additional details about the global Phase 2/3 COVID-19 study with opaganib for which we are anticipating top line data. As mentioned, we have completed the enrollment treatment and follow-up of 475 COVID-19 patients who were hospitalized with severe COVID-19 and required high-flow oxygen support at baseline, corresponding to Level 5 on the WHO ordinal scale of disease severity. The primary endpoint of the study evaluates the proportion of patients that improved clinically to breathing room air without oxygen support by day 14. The study will capture additional important clinical outcome measures in the follow-up period of up to 6 weeks, such as the incidence of intubation and mortality.
As mentioned, 4 independent DSMB recommendations to continue the study were already provided following unblinded safety and futility reviews. In addition, the study's blinded blended mortality rates are encouraging as compared to what might be expected in the study's patient population based on reported rates of mortality from large platform studies such as RECOVERY and other studies in similarly severe patient populations. Our expectation, fair discussions with senior expert consultants, is that the strength of clinical safety and efficacy data from the global Phase 2/3 study will be key to determining next steps and regulatory strategy.
RHB-107, also called upamostat, is our second COVID-19 oral pill therapeutic candidate. It is currently in an ongoing Phase 2/3 study in mild to moderate COVID-19 outpatients, which is the largest category of COVID patients. Upamostat is given orally once daily, early in the course of COVID-19. It has demonstrated good clinical safety, which is important for treating patients in this relatively early stage of infection with mild to moderate symptoms. Upamostat targets human serine proteases, which are involved in SARS-CoV-2 attachments and entry into the human cells. It has shown potent anti-SARS-CoV-2 activity in the preclinical disease model of human bronchial tissue.
As a simple to distribute and administer once daily oral pill, which is safe and potentially effective, upamostat fits the profile of a potentially ideal COVID-19 therapeutic as characterized by Dr. Fauci. A Phase 2/3 study of upamostat in COVID-19 outpatients in the U.S. is ongoing and we are in the process of expanding it globally to territories in which the infection is widespread. The study is targeting 310 patients to be enrolled in a 2-part randomized, double-blind, placebo-controlled Phase 2/3 study. The endpoints of the study include time to sustain recovery and the incidence of hospitalization and disease progression. Patients will also be tested for their specific viral strain.
On non-COVID-19 R&D programs, opaganib has been advancing through 2 oncology Phase 2 studies. As reported today, the ongoing investigator-initiated open-label Phase 2 study of opaganib in advanced prostate cancer met its primary endpoint of at least 6 subjects demonstrating disease control, defined as stable disease or better after 16 weeks on treatment among at least 27 evaluable subjects. In this study, opaganib is administered to patients who failed androgen inhibitor therapy on top of their baseline therapy.
Data entry is ongoing and results are based on preliminary review of partial data and remain subject to further review and analysis. Submission of the data for presentation at a major oncology conference is planned for early 2022. The second Phase 2 study, which is evaluating the activity of opaganib in advanced cholangiocarcinoma, is also ongoing. As previously reported, preliminary data from the first cohort of 39 patients indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is currently ongoing for a second cohort, which is evaluating opaganib in combination with hydroxychloroquine and anti-autophagy agent.
Another of our non-COVID programs is RHB-204, which is being evaluated in a Phase 3 study as a novel first-line therapy for nontuberculous mycobacterial infection. Nontuberculous mycobacterial infection is a rare disease with chronic debilitating manifestations and with no FDA-approved first-line therapy. RHB-204 is a promising potential first-line standalone oral therapy. It has been granted Orphan Drug designation, Qualified Infectious Disease Product designation and Fast Track designation. With these designations, it is eligible for priority review of the NDA and 12 years of market exclusivity.
The randomized placebo-controlled Phase 3 study is ongoing and is planned to enroll 125 subjects. We continue to experience low screening and enrollment due to the constraints imposed by the pandemic on site physicians and patients and we are planning to expand the study to additional territories outside the U.S. The key study endpoints of sputum culture conversion and patient-reported clinical outcomes will be evaluated at month 6 with ensuing longer-term follow-up, including the post-treatment maintenance of conversion.
I will now turn it to Rob, our Senior VP of Sales and Marketing, to update on our commercial progress.
Rob Jackson
Thank you, and good morning. Over the next few minutes, I'm going to summarize our second quarter 2021 sales, marketing and market access achievements.
In the second quarter, we achieved record quarterly revenue despite a very challenging pandemic environment. RedHill achieved growth with both Movantik and Talicia, and we're confident in our ability to capitalize on an improving selling environment during the second half of this year. In the second quarter, RedHill grew Movantik volume by 5.6% over the first quarter of this year. We achieved this by taking a disciplined approach to focusing on the pain segment. In tandem, we are also executing marketing strategies that focus on growing the PAMORA market. This is a key objective for Movantik as the established market leader.
We've heavily invested in digital marketing tactics to: first, raise opioid-induced constipation awareness with patients and prescribers; and second, to educate these potential customers about how Movantik can help provide relief from the symptoms of opioid-induced constipation.
During the second quarter, we also achieved significant market access successes with major payors that we hope will yield growth for Movantik during the second half of the year. Opioid-induced constipation represents a large and underserved growth opportunity for RedHill. The overwhelming majority of the 6 million to 12 million opioid users who may suffer from OIC report little to no benefit from non-PAMORA constipation treatments. Movantik is very well positioned to meet the needs of these patients. And as I mentioned earlier, the PAMORA market is stabilizing. This is a significant change for the therapeutic class. On a moving annual total basis, PAMORA prescribing volume bottomed out in February and has remained steady since. This is a very good sign for our Movantik business and reflects our efforts and investments to return the PAMORA class to growth.
Simultaneously, we also see that the rate of decline in U.S. opioid prescribing shows signs that it is also beginning to taper off. The downward trend in opioid prescribing has been occurring for many years. And if the trend continues to stabilize, it will provide an additional layer of support for the PAMORA market and Movantik.
On the payor front, our market access team has continued to improve our very competitive position with both commercial and Part D payors. In April, Movantik was included on the Cigna Medicare Part D formulary with no restrictions. In July, Movantik was also added to the Prime Therapeutics Net Results A Series formularies, which serve more than 30 million members, again, with no restrictions. Nine out of 10 commercial and government lives are covered from Movantik and we are confident that we can continue to improve our coverage.
Prescribers routinely refer to Movantik as the PAMORA drug with the best overall insurance coverage. And this is a key point of differentiation and a major reason why prescribers write Movantik today and will continue to prescribe Movantik in the future. RedHill is committed to ensuring consistent cost-effective insurance coverage for our brand and further strengthening our position as the market leader in this class.
In the second quarter, Talicia achieved more than 10% growth, and we are hopeful that this growth will accelerate in the second half of the year as recent payor wins take effect, new payor wins come to fruition and field execution continues to improve. Antimicrobial stewardship is an important issue. And when the most effective antibiotics are used first line, they provide the best chance for cure while eliminating the need for second, third and even fourth lines of treatment. As the Delta variant took hold in the second quarter, we employed live, digital and traditional print tactics to continue to reach our key prescribers. And in the second half of this year, we will continue to increase our focus on Talicia and plan to further accelerate our growth heading into 2022.
Talicia also continues to achieve new milestones and in the second quarter, Talicia achieved its best ever performance in terms of weekly prescription volume and quarterly prescription volume. Talicia also achieved a new high in commercial payor coverage. As with Movantik, Talicia commercial coverage also continues to improve and now covers 8 out of 10 commercial lives. In July, Talicia was added to the OptumRx commercial formulary with no restrictions, expanding access to another 26 million Americans.
H. pylori infection is the leading risk factor for the development of gastric cancer and the rapidly growing issue of clarithromycin resistance is very real for clinicians, payors and patients. And as more payors realize this important fact and they realize how clarithromycin resistance has a negative impact on prescribers and patients' abilities to eradicate H. pylori infections, they are becoming even more favorable to Talicia and even more reverse to clarithromycin containing therapies to treat H. pylori infections. The American College of Gastroenterology recognizes this in their guidelines for H. pylori therapy. And as we educate payors and prescribers, more of them understand the need to steer clear of the significant and growing challenge with clarithromycin based therapies, and instead, embrace the proven clinical benefits of Talicia.
We expect the trend of improving coverage to continue throughout 2021 and into 2022, providing even stronger support for accelerated growth.
We also continue to promote Aemcolo to consumers, PCPs and gastroenterologists. The COVID-19 pandemic has negatively impacted international travel, especially not essential travel outside the continental United States where travelers' diarrhea risk is greatest. Our midterm expectations are tempered by this reality. However, when travel returns, we are well prepared with excellent commercial coverage. 8 in 10 commercial patients now have access to Aemcolo.
In summary, we finished the second quarter on a strong note in the month of June. We achieved numerous commercial milestones for Talicia, including our highest weekly prescription volume, highest quarterly prescription volume and our highest level of commercial payor coverage. And as the market leader in the PAMORA class, we demonstrated our ability to continue to grow new Movantik prescriptions, stabilize prescription volume in the PAMORA class and further improve on our already strong Movantik payor coverage. We're looking forward to building on our performance in the second half of this year.
Thank you for your time, and I'll turn the call back to our CFO, Micha Ben-Chorin.
Micha Ben-Chorin
Thank you, Rob. Good morning. RedHill is delivering on a clear growth strategy designed to enable us to achieve planned potential commercial, operational breakeven by the end of this year.
We achieved a quarterly record of net revenues and gross profit in this quarter. And we also maintained a cash balance of $71.5 million as of June 30, 2021. Net revenues were $21.5 million for the second quarter of 2021, an increase of $0.9 million compared to the first quarter of this year. The increase was attributable to an increase in revenues from Talicia and Movantik despite the challenging pandemic environment. The record net revenues also enabled quarterly record gross margin of $10.9 million, which represents more than 50% of net revenues.
On the expenses side. We had higher expenses in the second quarter than in the first quarter related mainly to the progress of our COVID-19 development programs, the Phase 3 study of RHB-204 for pulmonary NTM disease, and to share-based compensation, mostly one-off expense relating to option exchange.
Operating loss and net loss were approximately $24.9 million and $29.1 million, respectively, for the second quarter of this year compared to $18.2 million and $22.9 million, respectively, in the first quarter of this year. The increase was mainly attributable to expense related to progression of our COVID-19 development programs, marketing programs and expenses related to share-based compensation, as just discussed.
Net cash used in operating activities increased by $6.6 million compared with the first quarter of 2021. The increase was attributable to anticipation of revenues collection in the first quarter. Cash expenses in the second quarter were actually lower than in the first quarter.
Net cash used in financing activities for the second quarter was approximately $1.8 million, comprised primarily of deferred payments with respect to Movantik acquisition in prior year.
Through financial discipline, we have ended the quarter with a cash position of $71.5 million, which allows us to continue to drive our core business forward.
I will now turn the discussion back to Dror.
Dror Ben-Asher
Thank you, Micha. We are happy to take questions.
Question-and-Answer Session
Operator
[Operator Instructions]. We're now taking our first question from the line of Ram Selvaraju at H.C. Wainwright.
Boobalan Pachaiyappan
This is Boobalan dialing in for Ram Selvaraju. The first one, last quarter, you mentioned about evaluating the clinical data from Cosmo's Phase 2 study involving rifamycin in IBS-D patients. So I'm just curious whether the analysis has been done and what would be the next possible steps.
Dror Ben-Asher
Thank you, Boobalan. We're glad to have you with us. We are still evaluating the data together with our partners and friends at Cosmo.
Boobalan Pachaiyappan
Okay. That's understood. And with respect to your opaganib inclusion in the I-SPY COVID trial, so what are your thoughts and expectations? And assuming your ongoing Phase 2/3 study involving hospitalized COVID patients are positive, and what are the next steps for the upcoming 12 to 24 months?
Dror Ben-Asher
The I-SPY BARDA funded study remains subject obviously to FDA clearance, just like any other study. We hope and expect that it will start soon. It's a parallel study. As we mentioned, we will be announcing the Phase 2/3 data soon. And we'll then evaluate what the next steps are. A lot depends on the data, not to say everything depends on the data. Because in our industry, data is key, and we plan on pursuing discussions with regulators, some of them ongoing, show them the data and hear them out and see what we do next. Everything depends on the data. The I-SPY BARDA funded study will go on. All goes well, regardless.
Boobalan Pachaiyappan
Along the lines, do you plan to study opaganib specifically in Delta variant infected patients in the future?
Dror Ben-Asher
All data from variants tested with opaganib has been consistent and very encouraging including today's news about strong inhibition of the Delta variant. The assumption right now, the work or assumption here at RedHill is that all goes well and subject to regulatory discussions and approval eventually in the U.S. and elsewhere. We will follow the label that is dictated by the regulators. In our study, there were no subsets that we planned on. We treated everybody.
When we started the study, there was no Delta or little Delta. Right now, it's mostly Delta in the U.S., but who knows where it is 6 months from now or 3 months from now. It could be a Lambda. It could be AY.3. It could be a lot of things. But I imagine that it's spreading across the U.S., which we are all following closely. And of course, the medical community is following closely.
So the label will be dictated by the regulators. We have not planned for any narrowing down of the label for a specific variant if and when a label is granted.
Boobalan Pachaiyappan
Great. One final question from me. So if you could comment on the current status of RHB-104, that will be great. And do you plan to do a confirmatory Phase 3 trial in Crohn's disease patients and will it involve a partnership?
Dror Ben-Asher
Yes. Great question. I'm really happy you asked about that. A confirmation Phase 3 study was planned all along and will be done. As far as next steps, we are making up our minds how that study should look like. We have some regulatory input where it should be conducted and how it should look.
What I can tell you is that, right now, it seems that primary endpoint will be based on imaging because mucosal healing is the holy grail. And if we are able to show that RHB-104 is the first drug that shows primary endpoint met in a significant manner, statistically significant manner, we should be able to make a lot of health care providers and, of course, patients and their families happy about the prospect of this investigational drug. Again, everything remains subject to regulatory discussion.
Operator
We are now taking our next question from the line of Bert Hazlett at BTIG.
Robert Hazlett
Yes. I've got just a couple more clarifying on opaganib. Is there a scenario where Phase 2/3 study results that are upcoming here in short order could actually lead to an EUA? And could you comment on the manufacturing status of opaganib just in that context? Then I've got 1 or 2 others.
Dror Ben-Asher
Thank you, Bert. I'll refer this to Gilead.
Gilead Raday
Thank you, Dror. As mentioned, the key is the data from the study. The results of the study, the efficacy and safety across the various endpoints that are being evaluated will determine the next steps in terms of regulatory process, in terms of emergency use authorizations in the U.S. and in other territories. So that will be what we're looking out for.
And in terms of manufacturing, I can say that because opaganib has the potential for broad utilization in the population and in the patients from mild to eventually mild but currently in severe patients, we are already deep in preparation to support scaled-up manufacturing that will support broad use.
Robert Hazlett
And just one other on opaganib. Do you have any sense of timing with regard to data in terms of the I-SPY trial?
Dror Ben-Asher
It's too early to say. We will be looking first for FDA clearance together with our intended partners at Quantum Leap and the I-SPY platform. Assuming this happens soon, we believe the study will commence very quickly and will enroll very quickly, because a study that is supported and conducted in conjunction with such a reputable and strong platform, the I-SPY platform of the Quantum Leap organization, and funded by very important arm of the U.S. government, by BARDA, is a study that health care providers, the prescribers, all the clinics that are being approached are likely to be -- to look at it favorably. It's not only RedHill, as a small company, conducting a study. This is a study that is on a different scale when it comes to who is backing it. So we cannot put time lines on it, but our belief is that the enrollment will be [finalized] once the study starts.
Robert Hazlett
Okay. And just a question or 2 on R&D. The R&D spend picked up materially this quarter. I'm assuming, based on your comments, that was largely due to NTM -- the initiation of the NTM study. If there are additional elements there, could you just describe them and how we should think about R&D spend? And then second...
Micha Ben-Chorin
Bert, so this was a quarter that we had a lot of progress on our COVID-19 program, which obviously took most of the R&D investment. And as we mentioned also in the press release, we also had a significant investment in the RHB-204 for the NTM study.
Robert Hazlett
That's helpful. And just a brief question on the prostate cancer data for opaganib as well. So does that create more enthusiasm with regard to your development in that indication? Should we expect additional investment there for opaganib in prostate cancer setting?
Dror Ben-Asher
I refer this to Gilead.
Gilead Raday
Thank you, Dror. Yes, we are very pleased with where we are now in the study. The data is encouraging, preliminary, of course, and subject to further data gathering. Opaganib has been in development in the oncology indications for quite a while now, given all the supportive information that we have about its activity and signals of activity both in prostate cancer and what we saw previously in cholangiocarcinoma. So taken together, we are continuing to develop opaganib in the oncology arena and continue to follow up on the existing ongoing studies. And once we have full data, we will aim to announce those in scientific presentations and conferences. And based on the final data, we will take decisions on next steps.
Robert Hazlett
We look forward to seeing the detail upcoming.
Gilead Raday
Thank you.
Operator
We are taking our next question from the line of David Hoang at SMBC.
David Hoang
Yes. So my first one is just on Talicia. As we head into the back half of the year, just wondering if you could comment on whether you think the major driver to seeing continued growth, is that more on continuing positive trends with the payor access or is it more with interaction between your sales force and prescribers as the -- as we get out of pandemic here?
Dror Ben-Asher
Thank you, David. Not to forget, before I refer this to Rick, that it depends also, to a large extent, on the state of the pandemic. Pandemic is affecting drug launches. It affects the clinics, affects the patients, the diagnostic labs, everything that has to do with Talicia. Yet we are seeing healthy growth, regardless. I'll refer this to Rick and the team.
Rick Scruggs
Yes. Thanks, Dror. It's a good question. I think if simply put, COVID has had a dampening effect on our ability to sell Talicia. Physician offices are closed. We see the lockdowns in the past. We are now at full sales force capacity. We have great payor coverage. We do anticipate the fourth quarter -- this quarter, third quarter and fourth quarter will be really good quarters for us. And all of this really hinges on COVID. So we have very good payor coverage. And our access right now to physicians is good, but that could change as COVID impact updates or gets worse or whatever. So that's the end of commentary for me, Dror.
Dror Ben-Asher
Thank you, Rick.
David Hoang
Okay. Great. So I also had a question just on the -- I know you have another molecule, 107, that's being investigated for COVID. If I recall correctly there, that's more of a, I think, outpatient focused molecule. So I was just wondering, is the sort of the development plan here that opaganib is strictly going to be on the inpatient hospitalized side and the other molecule will be outpatient? Or is it there's more overlap between the eligible population for both products?
Dror Ben-Asher
Thank you, David. It's a wonderful question. When COVID hit towards the spring or late winter 2020, all of us knew very little. RedHill is a small company, and we have to allocate our resources very carefully. The rational decision to do for opaganib was to go for hospitalized patients and not for non-hospitalized patients. Because non-hospitalized patients require an entirely different type of study. And because non-hospitalized patients mean the endpoints are very -- are different, relatively complicated to define. The costs of a study and monitoring patients outside clinical setting, again, complicates things. And the discussions with the regulators made very clear where the need is, which was severe patients, hospitalized, who are at very serious risk of deteriorating. So this is where we headed with opaganib.
We tested both opaganib and RHB-107 against SARS-CoV-2, and both of them yielded very exciting inhibition results. 107, we went for the outpatient or non-hospitalized population because opaganib was already in non-hospitalized, because it is once daily, which is ideal for symptomatic patients who are not at a hospital or at home and because we managed to figure out how to monitor them properly at home. And this took time. It's very complicated. Very few companies are actually trying to do it. And I believe very few have managed to successfully do so.
We commenced the study, the first patient in of the RHB-107 study was announced in February. So not that long ago. It's a U.S. study, but as Gilead said, we are expanding it to other places. And the beauty of having both opaganib and RHB-107, both of them are novel oral molecules that are expected to be effective against existing and emerging variants, because both act on the host cell as opposed to directly on the virus. The beauty of a small company having 2 shots on goal, so to speak, with novel oral molecules, is that it allows us right now with existing studies, assuming they're successful and subject to discussions with regulators, to cover the whole spectrum of the disease. So the vast majority of patients, of course, are not hospitalized. That's by far the biggest market.
Right now, what we have there is antibodies that require clinical setting, that are expensive. Some of them have been shown to be highly sensitive or showed weakness against the emerging variants, even pulled out of the market. And we have something that's very different. Novel oral small molecule once daily with RHB-107.
If we are successful, time will tell. This is a paradigm changing situation for non-hospitalized patients, which are probably 90% or more of the symptomatic patients. So it's a very exciting situation for us. And the turn of events chronologically was simply the more we learn, the more we were able to direct our programs according to what the status of the disease was, according to what the medical community was looking for, and according to our available resources. It's a long answer. I hope I answered your questions.
David Hoang
Yes, certainly. Thanks so much for taking the questions and the really detailed response and all the color. Super helpful. And looking forward to seeing the data soon.
Operator
We are now taking our next question from the line of Matt Kaplan at Ladenburg Thalmann.
Matthew Kaplan
Just wanted to zero in on the opaganib Phase 2/3 trial. Can you give us a sense in terms of how long it's going to take to crunch the data now that everyone is -- the major parts of the trial are complete and how soon we should get the data?
Dror Ben-Asher
Thank you, Matt. It's an important question. We have stated in our filings and also repeatedly today, that the data is upcoming, and we will keep it at that.
Matthew Kaplan
Okay. Fair enough. And then with respect to the Phase 2/3 trial, can you give us a sense in terms of the primary endpoint and some of the secondary endpoints in these severe patients? Your powering assumptions and in terms of patients -- proportion of the patients reaching room air by day 14. How should we think about that as the data is upcoming?
Dror Ben-Asher
Thank you, Matt. I'll refer this to Gilead.
Gilead Raday
Thanks, Dror. So Matt, we powered the Phase 2/3 global study for the primary endpoint for reaching room air by day 14 based on what we already saw from the Phase 2 study in the U.S. where we saw a difference of 50% versus 22% in the U.S. Phase 2 study. We took a conservative powering approach and looked for a 15% delta in that -- in the Phase 2/3 study globally. And that's how we arrived at the study size that we completed of 475 patients. So that covers the primary endpoint. And we also are looking for additional secondary endpoints, which are clinically meaningful and important, of course, and those include mortality and intubation and other clinical outcomes that are being captured in the global Phase 2/3 study.
Matthew Kaplan
Okay. That's very helpful, Gilead. And then in terms of the next steps for the prostate cancer program, can you give us a sense now that you've -- I guess, the Phase 2 met its primary endpoint. What are you thinking in terms of the continued development there for opaganib?
Dror Ben-Asher
Thank you, Matt. Glad you asked. We are very excited about this study. It's conducted at the American University of South Carolina. Phase 2 data with a novel molecule in prostate cancer is something that a lot of people are looking at. We as a company are very excited about. We know a lot about opaganib in oncology, be it cholangiocarcinoma, prostate cancer and other indications. And the plan is to complete the analysis, the review, everything that needs to be completed. We are looking to present it at a major oncology conference the way Gilead described, and take it from there.
I have to say there is several possibilities here, including pharma partnerships or we continue it alone. Either way, it's fine with us. The more we learn about opaganib's promise in various indications, including oncology, including specifically prostate cancer, the more excited we get about the prospect of helping patients.
I will also remind that we have been supplying opaganib to numerous oncology patients on a compassionate use basis subject to regulatory exemption in the U.S. and elsewhere. So it's not as if we are starting from scratch when it comes to our experience with compassionate use, with actual use both in the studies and outside the study subject to the regulatory exemption.
Matthew Kaplan
Okay. And then 2 more questions, one on pipeline and one on commercial. RHB-204 progress in the Phase 3 for NTM. You mentioned that enrollment has continued to be slow. Can you give us a sense in terms of what your thoughts are for the time line for that program kind of going forward as hopefully some enrollment picks up?
Dror Ben-Asher
Thank you. Yes, COVID has been harsh on enrollment, especially in respiratory indications and studies in respiratory indications. And yes, our enrollment has been slow. However, we have already activated many sites. We are confident that enrollment will continue to pick up especially as the COVID situation clears gradually over time. And even if it stays, both ourselves and the sites learn to live with it and conduct the study to the best of our ability regardless.
Time line, it's too early to say. Initially, we estimated about 1 year for enrollment to last patients out. But right now, given COVID, it changes so fast, so it's better to park it and maybe discuss during the next earnings call.
Matthew Kaplan
Okay. Fair enough. And then last question. Congratulations on the record revenues for the quarter. Can you give us a breakdown of the Movantik and Talicia revenues for the quarter?
Micha Ben-Chorin
Yes, sure. So the great majority of the revenues are with Movantik, obviously. And we have, obviously, Talicia as well with some additional revenues for Aemcolo. But the great majority is with Movantik.
Dror Ben-Asher
And Movantik is about 90%.
Operator
We are now taking our next question from the line of Scott Henry at ROTH Capital.
Scott Henry
Just a couple questions. First, on the R&D spend. I understand why it was high in 2Q, but it looks like it was about $7.5 million in Q1 and $10.3 million in Q2. When we think about the second half of the year, do you think it will look more like Q1 or Q2?
Dror Ben-Asher
We refer this to Micha.
Micha Ben-Chorin
This is a good question. And I believe it will be somewhere between Q1 and Q2. So I would expect lower expenses than Q2, but it could be in the level or a little bit higher than Q1.
Scott Henry
Okay. Fair enough. And then G&A also jumped in 2Q from $7.1 million to $10.2 million. Were there any onetime events there? Or -- just trying to get a sense of why the number was so high in 2Q?
Micha Ben-Chorin
Yes. So as you can see, we have substantial expenses there from a onetime option pricing. We did an option -- stock option exchange, which created onetime significant expenses, which are not expected to repeat in the future. This was the majority of the increase in expenses.
Scott Henry
Okay. So we should expect that to kind of revert back to that Q1 level? Is that fair?
Micha Ben-Chorin
Yes. This is fair to say.
Scott Henry
Okay. Great. And then just -- you made the comment that you expect commercial operations to be breakeven by the end of 2021. Now I mean, that always depends how one defines commercial operations. Typically, I would think of that meaning gross profit greater than selling expenses and G&A and just pulling R&D out of that equation. But it sounds like maybe are you also allocating some of your G&A out of the commercial operations? Or do you think that gross profit can be higher than G&A and selling expenses combined? And maybe you're pulling some selling expenses out as well. I just wanted clarity, if I could.
Micha Ben-Chorin
Yes. We are taking into account all the commercial expenses -- the relevant commercial expenses, which including also some of the G&A, obviously, includes the sales and marketing and not including the R&D. And we are basing it on a non-GAAP basis. So also not taking into account share-based compensation and other elements, which are non-GAAP. So -- and obviously, we are talking about the latest portion of the year. So this is our plan.
Scott Henry
Okay. So your -- basically, you want to exit Q4 with commercial operations positive, as defined by your prior comments? Okay. That is helpful. And then just a couple of quick clarification questions on the opaganib program in -- Dror, I don't know if you want to answer this or not, but I mean you've used words like shortly and upcoming for the data presentation. I'm not going to pin you down, but would you expect that data by the end of September, by the end of the third quarter? I mean, that would typically be a safe assumption, but I thought I'd give you a chance to confirm that.
Dror Ben-Asher
Yes, absolutely. There's nobody that wants to announce the data more than the team here with us right here. So we will make sure that the upcoming results reach the market as soon as possible. And yes, to answer your question, certainly, before the date that you mentioned.
Scott Henry
Okay. And then just the final question, which I know you've kind of been asked this from a couple of different angles. But I just wanted to get your take on if the data is statistically significant and strongly significant. With regards to the U.S. market, you've kind of said on one hand that the ability to file will depend on the data, but then in the press release, it specifically says that the FDA has indicated we will need to complete additional studies.
My question is, is the language in the press release, is that firm? Is it definitely you will need to do additional studies in the U.S.? Or is that always up to interpretation of the final data set?
Dror Ben-Asher
It's a very important point you raised. Everything that is stated is carefully worded up to the letter. This is exactly where we are with FDA. And our consultants who are ex-FDA and other experts are very clear that the data will dictate everything. Now this is correct not only for the U.S. but ex U.S. as well. I remind you that the vast majority of the market is outside the U.S. including Europe and many other countries. The disease is hitting right now pretty much everywhere. And we plan to evaluate the data with the regulators outside the U.S. as well as the FDA once it's available.
Operator
There are no more questions on the line. I will hand it over back to Dror for closing remarks.
Dror Ben-Asher
Thank you, Andrea, and thank you, all, for joining the call. Please feel free to reach out to us if you have any additional questions. Keep safe, and we wish you all a pleasant day.
Operator
That concludes the call for today. Thank you for participating. You may all disconnect.
RedHill shares rise after opaganib preclinical data, Q2 results
Aug. 26, 2021 10:11 AM ETRedHill Biopharma Ltd. (RDHL)
By: Aakash Babu, SA News Editor
RedHill Biopharma shares rise (RDHL +3.0%) after highlighting new preclinical data supporting opaganib's potent inhibition of Delta COVID-19 variant as the company reported Q2 results.
The company posted quarterly revenue that increased 3% to $21.5M, helped by the sales from Talicia and Movantik treatments.
Preliminary results from a preclinical study showed a reduction of IL-6 in the basal supernatants of SARS-CoV-2 infected human airway epithelial cells treated with opaganib.
Following completion of treatment and follow-up in the opaganib global 475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia, top-line results are expected shortly.
The company also said that it is continuing discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the development and manufacturing scale-up of opaganib.
This is GOOD news, albeit not the
news we expect, namely the global
results that is due any day now.
Yes - saying same even now - look at the price - it has come down now
1.2 MILLION TRADES ALREADY-UP-.35.-SCUMBAGGS ARE DILUTING IS MY GUESS
YOU ARE THE ONE THAT CALLED IT GOOD NEWS. NOT GOOD NEWS
RedHill Biopharma Reports Second Quarter 2021 Financial Results and Operational Highlights
https://finance.yahoo.com/news/redhill-biopharma-reports-second-quarter-110000721.html
- Achieved record quarterly revenues of $21.5 million for Q2/2021, 4.5% increase from Q1/2021 despite challenging market conditions; Cash balance1 of approximately $71.5 million as of June 30, 2021
- Record Talicia® quarterly prescription volume up more than 10%; Movantik® quarterly new prescriptions up 5.6%; Talicia and Movantik coverage expanded to 8 and 9 out of 10 commercially insured Americans, respectively
- Opaganib in final stages of selection by Quantum Leap Healthcare Collaborative and BARDA for inclusion in the I-SPY COVID-19 platform trial with funding provided by BARDA
- New preclinical data supports opaganib's potent inhibition of Delta COVID-19 variant
- Top-line results from global Phase 2/3 COVID-19 study upcoming following completion of treatment and follow-up
- Primary endpoint met in the ongoing prostate cancer Phase 2 study of opaganib, based on a preliminary review of partial unaudited data; patient accrual, treatment and analysis ongoing
- Management to host webcast today, at 8:30 a.m. EST
TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2021 /CNW/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the second quarter ended June 30, 2021.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have achieved important progress across the board this quarter. Opaganib is one of the leading drug candidates in the race to develop an effective COVID-19 therapeutic pill. New data further supports opaganib's potent inhibition of SARS-CoV-2 variants of concern, including the rapidly spreading Delta variant. The upcoming Phase 2/3 top-line data could tell us if we have a potential game-changing oral pill treatment for severe COVID-19, one that is aligned with the ideal product profile described by public health experts." Mr. Ben-Asher continued: "Commercially, we are continuing to see the fruits of our labor, with significant growth in both Talicia and Movantik prescriptions. Importantly, record quarterly Talicia prescriptions and improving commercial payor coverage are testament to the growing understanding of the need to treat H. pylori in a way that minimizes treatment failure due to antibiotic resistance. This sets us up for continued strong growth."
Micha Ben Chorin, Chief Financial Officer at RedHill, added: "From a financial perspective, the revenue growth in the second quarter, despite the challenging pandemic conditions, highlights the execution excellence of our U.S. commercial organization. Achieving record revenues of $21.5 million while maintaining gross margin above 50% represents a key accomplishment on RedHill's growth path to become a leading specialty pharma player."
Financial highlights for the quarter ended June 30, 20212
Net Revenues were approximately $21.5 million for the second quarter of 2021, an increase of $0.9 million compared to the first quarter of 2021. The increase was attributable to an increase in revenues from Talicia® and Movantik® despite the challenging pandemic environment.
Gross Profit was approximately $10.9 million for the second quarter of 2021, representing an improved gross margin of approximately 51%.
Research and Development Expenses were approximately $10.3 million for the second quarter of 2021, an increase of $2.8 million compared to the first quarter of 2021, mainly attributable to the progression of our COVID-19 development programs.
Selling, Marketing and General and Administrative Expenses were approximately $25.5 million for the second quarter of 2021, an increase of $4.5 million compared to the first quarter of 2021. The increase was mainly attributable to expenses related to share-based compensation and investment in marketing.
Operating Loss and Net Loss were approximately $24.9 million and $29.1 million, respectively, for the second quarter of 2021, compared to $18.2 million and $22.9 million, respectively, in the first quarter of 2021. The increase was mainly attributable to expenses related to the progression of our COVID-19 development programs, marketing programs and expenses related to share-based compensation, as detailed above.
Net Cash Used in Operating Activities was approximately $18.9 million for the second quarter of 2021, an increase of $6.6 million compared to the first quarter of 2021. The increase was mainly attributable to changes in working capital in the second quarter.
Net Cash Used in Financing Activities was approximately $1.8 million for the second quarter of 2021, comprised primarily of payables with respect to Movantik.
Cash Balance1 as of June 30, 2021, was approximately $71.5 million.
Commercial Highlights
Movantik® (naloxegol)3
The Company's focus on initiatives to drive Movantik market growth and gain market share has resulted in a strong quarterly performance for Movantik, registering a 5.6% increase in new prescriptions.
The Company has also achieved significant market access successes with U.S. major payors, continuing to increase the levels of payor coverage. In July, the Company announced that one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, had added Movantik as a preferred brand with no restrictions to its Commercial NetResults "A" series formularies and as a preferred brand on its other commercial formularies starting July 1, 2021. In April, Movantik was also included on the Part D formulary of another major payor with no restrictions. Almost 9 out of 10 U.S. commercial lives are now covered and we continue to work toward additional formulary coverage for the remaining patients.
In July 2021, the Company announced that RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP and Nektar Therapeutics had entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. (Apotex) resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application (ANDA) seeking approval by the U.S. FDA to market a generic version of Movantik. Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to FDA approval) or earlier under certain circumstances.
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)4
Talicia achieved a record quarter, delivering more than 10% growth in prescription volume, compared to the previous quarter.
In July, the Company significantly expanded commercial coverage for Talicia, announcing that OptumRx, part of the UnitedHealth Group, a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, had added Talicia to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021. This agreement expands access to Talicia to 26 million additional Americans and increases overall patient access to Talicia to greater than 8 out of 10 covered U.S. Commercial lives.
Aemcolo® (rifamycin)5
The Company has increased promotion of Aemcolo in the second quarter of 2021 as travel to Mexico increased. Plans are in place to support and build on the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. The Company expects that these plans will drive a resurgence of interest in Aemcolo once international travel from the U.S. returns to significant levels.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)6
Following completion of treatment and follow-up in the opaganib global 475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840), top-line results are expected shortly – likely positioning opaganib as the first novel investigational dual-action COVID-19 oral pill set to deliver late-stage clinical data from patients with severe COVID-19.
Nearing the end of extensive review, Quantum Leap Healthcare Collaborative and the U.S. government's Biomedical Advanced Research and Development Authority (BARDA) are close to selection of opaganib for inclusion in the I-SPY COVID-19 Trial, with funding for opaganib provided by BARDA. The I-SPY platform is intended for rapidly testing promising therapeutic candidates for severely ill COVID-19 patients.
Opaganib, a novel, oral pill sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targets a human host factor and is expected to exert its activity across the different variants. Supporting this the Company recently announced preliminary results of a new preclinical study with opaganib demonstrating strong inhibition of the COVID-19 Delta variant of concern, while maintaining cell viability at relevant concentrations. Together with the previously announced inhibition of Beta and Gamma variants, this demonstrates that opaganib has the potential to maintain its effect against further emerging spike protein mutations.
Moreover, preliminary results from preclinical work, conducted at the University of Louisville, demonstrated a reduction of IL-6 in the basal supernatants of SARS-CoV-2 infected human airway epithelial cells treated with opaganib, and opaganib has previously demonstrated reduced thrombosis in a preclinical model of ARDS. These findings demonstrate the anti-inflammatory effects that opaganib exerts, in addition to its antiviral activity.
Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, presented in June at the World Microbe Forum (WMF) 2021, as well as encouraging compassionate use experience in Switzerland and Israel and potent inhibition of COVID-19 in preclinical studies. The opaganib Phase 2/3 study has also passed four Data Safety Monitoring Board reviews, including a futility review, and extends the total opaganib safety database to more than 460 patients.
The Company previously announced that it had signed collaborations with several U.S., European and Canadian suppliers, including with Cosmo Pharmaceuticals for large-scale ramp-up of opaganib manufacturing, further strengthening manufacturing capabilities and capacity of opaganib.
The Company maintains ongoing discussions with the FDA, EMA and other regulators, on potential pathways to marketing approval, with next steps to be guided by upcoming study results. The regulatory path for opaganib, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive, as well as the specific requirements in each country. Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has indicated we will need to complete additional studies to support applications in the U.S. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.
The Company continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the development and manufacturing scale-up of opaganib. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries.
COVID-19 Program: RHB-107 (upamostat)7
RedHill continues to advance the U.S. Phase 2/3 COVID-19 study with novel, once-daily, orally-administered, antiviral drug candidate, RHB-107 (upamostat). The study with RHB-107 is evaluating treatment of non-hospitalized patients with symptomatic COVID-19 early in the course of the disease who do not require supplemental oxygen - the vast majority of COVID-19 patients.
RHB-107 targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors and is therefore expected to be effective against emerging viral variants with mutations in the spike protein.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection.
The Company previously announced that the FDA granted Fast Track designation for RHB-204, providing early and frequent communications and a rolling review of any New Drug Application (NDA). RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
RHB-204 was granted FDA Orphan Drug designation and Qualified Infectious Disease Product designation, extending its U.S. market exclusivity to a potential total of 12 years upon potential FDA approval.
Opaganib - Cholangiocarcinoma and Prostate Cancer
According to a preliminary review of partial and unaudited data in the ongoing investigator-initiated open-label Phase 2 study of opaganib in combination with androgen inhibitors in advanced prostate cancer at the Medical University of South Carolina (MUSC) and Emory University, the study has met its primary endpoint of at least 6 subjects demonstrating disease control (defined as stable disease or better after 16 weeks on treatment) among at least 27 evaluable subjects. The study enrolls patients who have already failed androgen inhibitor therapy, with opaganib being added to the failed inhibitor to reverse resistance which has developed. Data entry is ongoing and results remain subject to further review and analysis. Submission for presentation at a major oncology conference is planned for early 2022.
The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing at Mayo Clinics in Arizona and Minnesota, Emory University and the Huntsman Cancer Institute at the University of Utah. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is ongoing for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.
Conference Call and Webcast Information:
The Company will host a webcast today, Thursday, August 26, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the second quarter of 2021.
The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel: +972-3-530-8845; the access code for the call is:5554521.
About RedHill Biopharma
RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding achieving fast growth and increased profit margin, selection of opaganib for inclusion in the I-SPY COVID-19 Trial, with funding for opaganib provided by BARDA, the timing of top-line results from our global Phase 2/3 COVID-19 study and the resurgence of interest in Aemcolo®. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, that opaganib and RHB-107 will not be effective against emerging viral variants, that selection of opaganib for inclusion in the I-SPY COVID-19 Trial, with funding for opaganib provided by BARDA, will be delayed or not occur, that there will be a less than anticipated interest in Aemcolo® as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate and Business Development
Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contacts:
U.S.: Bryan Gibbs, Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
REDHILL BIOPHARMA LTD.
Don’t shoot the messenger - from the PR - read 3 para below
“The regulatory path for opaganib, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive, as well as the specific requirements in each country.
Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required.
For example, the FDA has indicated we will need to complete additional studies to support applications in the U.S. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.”
your-nuts-good-news-another-trial-bs-don't-trial-us-to-death
From the PR
Good part “Nearing the end of extensive review, Quantum Leap Healthcare Collaborative and the U.S. government's Biomedical Advanced Research and Development Authority (BARDA) are close to selection of opaganib for inclusion in the I-SPY COVID-19 Trial, with funding for opaganib provided by BARDA.
The I-SPY platform is intended for rapidly testing promising therapeutic candidates for severely ill COVID-19 patients.”
Not so good - FDA has indicated that additional trials will be needed for full approval.
They have $78 million in cash - not sufficient for 2 new products.
So hope they will wait for the topline results - if the results are good to great - the SP will spike and they can raise more money at higher price and low dilution
Fingers crossed - it is like we have written exam paper and nothing in our hand and waiting for results
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
972 3 541 3131
http://www.redhillbio.com
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