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I am very close to losing
hope altogether.
Any chance if this coming back to life?
RedHill Biopharma COVID treatment reduces severe symptoms in mid-stage trial
Mar. 01, 2022 11:27 AM ETRedHill Biopharma Ltd. (RDHL)
By: Jonathan Block, SA News Editor
RedHill Biopharma's (NASDAQ:RDHL) oral COVID-19 treatment RHB-107 (upamostat) demonstrated a significant reduction in new severe symptoms in non-hospitalized, symptomatic COVID patients in a phase 2 study.
In the study, no patients on RHB-107 were hospitalized, compared to 15% on placebo.
Just 2.4% of patients on upamostat developed new severe symptoms, compared to 20% in the placebo arm.
RHB-107 also demonstrated a favorable safety and tolerability profile.
Last month, RedHill (RDHL) reported that another oral COVID-19 therapy, opaganib, "significantly reduced" death among hospitalized patients.
RedHill Announces Positive Phase 2 Study Results with Oral RHB-107 in Non-Hospitalized COVID-19
https://finance.yahoo.com/news/redhill-announces-positive-phase-2-140000003.html
Phase 2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic COVID-19 successfully met the study's primary endpoint showing good safety and tolerability and highly promising efficacy results
100% reduction in hospitalization due to COVID-19 with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm
87.8% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-controlled arm)
The most common variant among patients in the study was Delta; RHB-107, a novel, investigational oral antiviral serine protease inhibitor, targeting host rather than viral factors, is expected to maintain effect against emerging viral variants
TEL AVIV, Israel and RALEIGH, N.C., March 1, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive top-line results from the Phase 2 part of the Phase 2/3 study of once-daily oral RHB-107 (upamostat)[1] in non-hospitalized symptomatic COVID-19 patients, predominantly conducted in the U.S. (60/61 patients) as well as South Africa.
Although not powered for efficacy assessment, the study showed highly promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107 hospitalized with COVID-19 (0/41) compared to 15% on the placebo-controlled arm requiring hospitalization (3/20) (nominal p-value=0.0317). Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms (nominal p-value=0.036).
The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107. Study arms were well balanced with respect to baseline disease severity, risk factors and vaccination status. Patients were also tested for the specific viral strain (last patient randomized November 12, 2021), with the most common variant being Delta, found in 62.5% of the patients that had next generation sequencing (NGS).
"These very promising efficacy results, achieved despite a small overall sample size, are impressive. Coupling the efficacy results with successfully meeting the primary endpoint of good safety and tolerability and convenient once-daily dosing, positions oral RHB-107 as a potential highly beneficial treatment for COVID-19 outpatients early in the course of disease in order to reduce symptom severity and prevent disease progression and hospitalization. Given the limitations of current options for early treatment of COVID-19, we are excited to progress the development of RHB-107, subject to additional discussions with regulatory authorities," said Terry F. Plasse MD, Medical Director at RedHill. "Equally important is our expectation that RHB-107, with its human cell factor targeting, would maintain its action irrespective of spike protein mutations, thus likely making it a highly desirable variant-agnostic potential treatment option."
The Phase 2/3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The Phase 2 part of the study was designed to evaluate safety for dose selection and to provide preliminary assessment of parameters to be used for efficacy evaluation in Part B. A total of 61 patients were enrolled in Part A and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.
Next steps for the study will follow data submission and discussion with regulators.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets host cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma (FSE: HPHA) (formerly WILEX AG) for all indications.
RedHill Biopharma preliminary Q4 net revenue falls short of estimates
Feb. 17, 2022 10:55 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor
RedHill Biopharma (RDHL -1.7%) expects Q4 total net revenues to be in the range of $22M to-24M, below the consensus revenue estimate of $24.09M, according to preliminary data.
The company had recorded $21.5M in revenue in Q4 2020.
RedHill expects to have achieved commercial operations breakeven in Q4 and expect profitable commercial operations in 2022 (both non-GAAP EBITDA).
As of Dec. 31, 2021 cash balance was $54.2M, compared to $45.9M as of Dec. 31, 2020.
Record Talicia quarterly new prescriptions, increase of 26.5% vs. Q3 2021, and 78.4% vs. Q4 2020.
Movantik new prescriptions grew by 2.4% vs. Q3 2021 and 4.5% vs. Q4 2020
Substantial decrease in operational and development expenses following implementation of a cost-efficiency plan.
"Strong sales growth momentum in the face of the persistent pandemic environment, coupled with strengthening our salesforce through internal realignment to include 120 customer-facing sales professionals, disciplined cost-control measures and the potential addition of products synergistic to our existing commercial basket, are planned to bring us closer to commercial operations profitability in 2022," said RedHill's CEO Dror Ben-Asher.
The company intends to announce its Q4 and full year 2021 results in the coming weeks.
It seems that only a D-9 can
do something to move s/p up.
So why aren’t we much higher?
Where should the price be?
RedHill Biopharma Announces Record Quarterly Revenues and First Commercial Operations Breakeven
https://finance.yahoo.com/news/redhill-biopharma-announces-record-quarterly-143000661.html
TEL AVIV, Israel and RALEIGH, N.C., Feb. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today provided a business update for the fourth quarter of 2021, including certain estimated unaudited preliminary financial data.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Strong sales growth momentum in the face of the persistent pandemic environment, coupled with strengthening our salesforce through internal realignment to include 120 customer-facing sales professionals, disciplined cost-control measures and the potential addition of products synergistic to our existing commercial basket, are planned to bring us closer to commercial operations profitability in 2022. In parallel, our compact R&D team continues to display tremendous creativity and drive in progressing RedHill's robust late clinical-stage pipeline. In particular, extensive discussions are ongoing with regulators in multiple countries regarding potential pathways to approval of orally-administered opaganib, likely the first novel oral drug candidate to have shown an improvement in viral clearance in severe hospitalized COVID-19 patients."
The Company intends to announce its audited fourth quarter and full year 2021 results in the coming weeks. The preliminary financial data ranges described herein have not been audited and are subject to adjustment based on the Company's completion of year-end financial close processes.
Added Positions: BMY, OLLI, NEM, RDS.B, CM, PYPL, SU, TKC, CP, RDHL, GOOG, MA, V, EWZ, DIS, FTS, CRM, AGRO,
https://finance.yahoo.com/news/claret-asset-management-corp-buys-183813521.html
RedHill Biopharma says oral COVID-19 therapy lowered mortality in hospitalized patients
Feb. 07, 2022 10:59 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
Announcing data from a Phase 2/3 trial for its COVID-19 therapy opaganib, RedHill Biopharma (RDHL -2.4%) said Monday that the oral treatment “significantly reduced” death among hospitalized patients who had previously received standard-of-care (SOC).
According to the prespecified mortality analysis, among those who were receiving SOC of remdesivir and corticosteroids, opaganib treated patients were found to have a 70.2% mortality benefit. The second prespecified analysis indicated that the experimental therapy led to a significant 34% benefit in time to recovery.
The company is planning to seek potential regulatory authorizations for the treatment in certain countries in H1 2022, and the regulatory submissions have already begun in the U.S., Europe, the U.K., and additional countries.
In September, RedHill (NASDAQ:RDHL) said that the global Phase 2/3 study for opaganib did not meet the primary endpoint in hospitalized patients with severe COVID-19 pneumonia.
RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19
RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19
Updates on Regulatory Discussions and Plans in Multiple Countries
Prespecified analysis of Phase 2/3 opaganib data in severe COVID-19 patients showed a significant, 70.2% mortality benefit with opaganib by Day 42 when given on top of the best available standard-of-care (SoC), remdesivir and corticosteroids (6.98% mortality in the opaganib arm versus 23.4% for placebo, p-value=0.034)
--
A second prespecified analysis showed that opaganib also delivered a significant 34% benefit in 'time to recovery by Day 14', with 37.4% of opaganib-treated patients reaching this event versus 27.9% of patients treated with placebo + SoC (p-value=0.013)--
These additional prespecified mortality and recovery analyses, along with previously announced data showing opaganib's improved median time to SARS-CoV-2 viral RNA clearance, further strengthen the positive outcomes in the Phase 2/3 study post-hoc analysis. All data is being shared with regulators
--
Opaganib data submissions initiated in Q4/21, initial guidance on potential path to approval received from the EU's EMA, the U.S. FDA, UK's MHRA and others, discussions ongoing
--
Based on regulatory feedback and external advice received from other territories, potential emergency and marketing authorization applications planned in H1/2022
https://finance.yahoo.com/news/redhill-biopharmas-oral-opaganib-reduces-151500444.html
TEL AVIV, Israel and RALEIGH, NC, February 7, 2022 -- InvestorsHub NewsWire -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results from two recently completed prespecified analyses from the oral opaganib (ABC294640)[1] Phase 2/3 study in hospitalized severe COVID-19. The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients. A second analysis further showed that opaganib delivered a significant benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14. The Company is advancing regulatory discussions in multiple countries, with potential emergency and marketing authorization applications being planned for certain countries in the first half of 2022.
The prespecified mortality analysis, undertaken for all patients from the Phase 2/3 study who were receiving remdesivir and corticosteroids at baseline, demonstrated a significant 70.2% mortality benefit for opaganib-treated patients, with a mortality rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4% (n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
The second prespecified analysis showed opaganib delivered a significant 34% benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4% of opaganib-treated patients (n=86/230) reaching this event versus 27.9% of patients (n=65/233) treated with placebo + SoC (p-value=0.013, Hazard Ratio 1.49)
"These prespecified analyses, along with the recent data showing opaganib's improved median time to viral RNA clearance, provide strong support for the promising results observed in the Phase 2/3 study post-hoc analysis. Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo. Strikingly, opaganib has delivered these benefits over and above the very best level of current standard-of-care, with patients receiving both remdesivir and corticosteroids," said Dr. Mark Levitt, RedHill's Chief Scientific Officer. "The hospitalized moderate to severe COVID-19 patient group is estimated to represent more than 50% of all hospitalized COVID-19 cases and growing. The prevalence of Omicron, new emerging variants, loss of efficacy of existing drugs against such variants and the difficulty in stopping COVID-19 early enough in its course, despite the availability of new drugs, all point very clearly to the urgent need for new, preferably orally-administered, therapeutic options, unaffected by spike protein mutations, for this underserved and substantial patient population."
Regulatory progress continues to be made, with opaganib data submissions initiated in the fourth quarter of 2021 in the U.S., Europe, UK and additional countries. Discussions remain ongoing and initial guidance on a confirmatory study and potential path to approval has been received from the EU's EMA, the U.S. FDA, UK's MHRA and others. Based on regulatory feedback from other territories and external advice received, the Company is also planning potential emergency and marketing authorization applications in certain such countries in the first half of 2022.
Oral opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). In a prespecified analysis of all Phase 2/3 study patients with a positive PCR at screening[2] opaganib improved the median time to viral RNA clearance by at least 4 days, achieving viral RNA clearance in a median of 10 days, while the median for clearance was not reached by the end of 14-days treatment in the placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). Additionally, results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
With EUA approval in Colombia, i would
expect an immediate 50% spike in price.
Should other regions follow suit, i
expect sp to exceed $10.
Huge sp bonanza should the US or UK
approval/s is/are achieved, and naturally
some mega partnership would obvious occur.
In short, my hopes for my breaking even
are high!
Big if tho.......
Fingers crossed
Interesting…if approved how high do you see the stock price going?
Kukbo Co., Ltd., a KOSPI-listed company, announced on the 28th that the US/Israel biotechnology company RedHill Biopharma's oral treatment for moderate/severe corona virus Opaganib will be approved for emergency use in the first half of the year.
Currently, the EUA (Emergency Use Authorization) procedure is the fastest in Colombia and there is very positive feedback, so emergency use approval is scheduled for mid-February. said. Additional data have been submitted to the US and EU, and it is known that the emergency approval process will soon begin through feedback from regulators.
Kukbo acquired a stake in Red Hill in November of last year and distributes oral COVID-19 treatments (Opaganib, RHB-107 (Upamostat)) and Talica® developed by Red Hill in Korea as well as major Asian regions. In the first quarter of this year, it has been given the right to preferential negotiation of the copyright contract, and signed a business performance service contract for Opaganib with LSK Global Pharma Service, a leading domestic clinical contract company (CRO) in December. Following the NDA Submission, the domestic emergency use approval procedure is in progress, and attention is focused on the result.
Red Hill's Opaganib is the only oral corona treatment that can treat severe and moderate COVID-19 patients. Compared to patients receiving standard treatment (remdesivir or dexamethasone), Red Hill's Opaganib reduced mortality in severe patients by 62%, It has published improved clinical results over time, and it is less burdensome and less burdensome to take compared to Pfizer's 'Paxrovid', which requires taking 30 tablets for 5 days by taking 2 tablets (1 tablet at a time) for 7 to 14 days. It is also known to have price competitiveness and is expected to attract attention.
In addition, Opaganib has demonstrated dual anti-inflammatory and antiviral activity targeting palliative cellular components, and as a sphingosine kinase-2 (SK2) selective inhibitor, it has been demonstrated to potentially minimize the possibility of viral resistance, thereby demonstrating superiority in the basal aspect. It has been proven, and it has been proven that the individual combination of Opaganib and RHB-107 (Upamostat) has a potential antitumor effect and antitumor effect on patients with cholangiocarcinoma, and has received a patent application from the US Patent and Trademark Office (USPTO).
Source: Global Economic Daily (http://www.getnews.co.kr)
Good News a-coming?
Kukbo announced that RedHill Biopharma, an Israeli biotechnology
company in the United States and Israel, will receive emergency
use approval for Opaganib, a moderate-to-severe oral treatment for
COVID-19, in Colombia and Russia in the first half of the year.
Source:Stocktwits
Sold Out: BWMX, CLLS, DBVT, RDHL
https://finance.yahoo.com/news/henry-james-international-management-inc-183826636.html
I was pleasantly surprised RDHL was
up yesterday when the XBI index was
3.5% down.
To your question: I am still in,
reflecting my hopes RDHL will recover.
Any hope for this thing to come back?
Re RDHL
Fully agreed.
Re ORMP
Liquidated 100%. At least covered some
of my RDHL losses. Not enough tho.
Re BLRX
Some hopes there. Not too long a wait
to find out.
This co really fxxxed up royally.
Hope ORMP does not go the same way
RedHill says oral COVID-19 therapy improved viral clearance in severely ill patients
Jan. 13, 2022 11:18 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announced that its oral COVID-19 therapy opaganib “significantly” improved viral clearance in a Phase 2/3 trial involving severely ill hospitalized patients with the disease.
In patients with positive PCR at screening, the median time to viral RNA clearance with opaganib improved by at least four days. In the opaganib arm, the median for viral clearance was ten days, while the placebo arm did not reach the clearance median by the end of the 14-day treatment.
(Hazard Ratio 1.34; nominal p-value=0.043, N=437/463).
With a median of 11-days from the onset of symptoms, the patient group was much further advanced than the mild-to-moderate outpatients for whom the currently FDA authorized COVID-19 therapies are indicated.
In July, RedHill (RDHL) announced the completion of treatment and follow-up in the 475-patient Phase 2/3 study for opaganib.
RedHill Biopharma's Oral Opaganib Significantly Improves Viral Clearance in Phase 2/3 Study in Severely Ill Hospitalized COVID-19 Patients
https://finance.yahoo.com/news/redhill-biopharmas-oral-opaganib-significantly-153500501.html
- In a prespecified analysis of all Phase 2/3 study patients with positive PCR at screening, opaganib improved the median time to viral RNA clearance by at least 4 days; Median of 10 days for viral clearance in the opaganib arm vs. clearance median not reached by end of 14-day treatment in placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463)
- Opaganib is the first oral novel drug candidate to show improved viral RNA clearance in patients with severe COVID-19 pneumonia; Provides clinical evidence supporting opaganib's potential antiviral activity
- Results achieved in a severely ill hospitalized patient population with a median of 11-days from onset of symptoms - a patient population much further advanced than mild-moderate outpatients with less than 5 days from symptom onset, for which oral anti-viral medications have recently been approved
- Results add to opaganib's 62% reduction in mortality seen in a post-hoc analysis of the Phase 2/3 study and are being provided to regulators as part of ongoing discussions on potential pathways to approval in multiple countries
TEL AVIV, Israel and RALEIGH, N.C., Jan. 13, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new data from a prespecified analysis of all oral opaganib's[1] Phase 2/3 study patients with positive PCR at screening, demonstrating that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463).
"Opaganib is the first oral novel drug candidate to demonstrate SARS-CoV-2 viral RNA clearance in hospitalized patients with severe COVID-19 pneumonia. It also provides the first clinical demonstration of opaganib's potential antiviral activity, supporting the 62% reduction in mortality seen in the post-hoc analysis of a large subset of patients from the Phase 2/3 study and confirming the viral inhibition observed in preclinical testing against Delta and other variants," said Dr. Mark Levitt, RedHill's Chief Scientific Officer. "It is important to note that these results were achieved in a severely ill hospitalized patient population and following an 11-day median time from onset of symptoms - an entirely different patient population from the mild-moderate outpatients with less than 5 days from symptom onset, for whom oral antivirals have been recently approved. It is also important to keep in mind that as opaganib's proposed mechanism of action targets a host factor, its activity is not expected to be affected by mutations in the spike protein emerging with new viral variants, including Omicron."
Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840) with positive PCRs at screening obtained for 437 out of 463 patients (the remaining patients could not be included in this prespecified analysis due to lack of PCR results at screening). Results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.
RedHill is vigorously pursuing the development program for opaganib and is in ongoing discussions with multiple regulatory agencies regarding potential pathways to approval.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
RedHill Biopharma and Gaelan Medical Enter Into License Agreement for Talicia® for the United Arab Emirates
https://finance.yahoo.com/news/redhill-biopharma-gaelan-medical-enter-141500473.html
Gaelan Medical to pay RedHill $2 million upfront plus potential regulatory and sales milestones and tiered royalties on net sales, for the exclusive rights in the United Arab Emirates to Talicia®
Talicia is a U.S. FDA-approved treatment for H. pylori, a bacterial infection that affects more than 50% of the world's adult population representing significant unmet need
RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1], an H. pylori therapy, in the United Arab Emirates (UAE).
Under the terms of the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.
"We are delighted to partner with Gaelen Medical to help bring Talicia to H. pylori patients in the UAE and potentially other territories in the region," said Dror Ben-Asher, RedHill's CEO. "This partnership is particularly important given that H. pylori, a major public health concern, impacts up to 84% of the population in the region[2] and is one of the strongest risk factors for gastric cancer, leading to a recent regional clinical consensus meeting calling for eradication therapy to be offered to all individuals infected with H. pylori[3]. We are seeing rapid growth of Talicia in the U.S. in light of the alarming failure rates of clarithromycin-based therapies and growing physician awareness of the need for highly effective first-line H. pylori therapy. We continue to explore with potential partners the expansion of Talicia's reach into additional ex-U.S. territories."
"H. pylori can cause extensive damage if not properly eradicated first-time and there is considerable need for a therapy like Talicia in the UAE, where 41% of the population[4] is affected and have limited options for treatment," said Ghassan Aboud, Chairman of GAG. "Talicia would become the first approved combination product in the UAE specifically designed to treat H. pylori, and we are excited to be partnering with RedHill and at the prospect of realizing Talicia's potential to help patients with H. pylori infection in the UAE and potentially other territories in the region."
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[5] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[6].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
RedHill Biopharma: Looking At An Unexciting Dead-End
Dec. 30, 2021 3:32 PM ETRedHill Biopharma Ltd. (RDHL)
Summary
RDHL has had many avatars, and the latest one has taken the stock down considerably.
There does not seem to be a defining nature in RDHL's business.
I will avoid this for now.
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Panoramic aerial view of a upscale suburbs in Atlanta
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About RedHill Biopharma (RDHL), I said the following exactly a year ago - "a somewhat boring, long-term, relatively risk-free, low-headache investment for investors." What happened to RedHill to take it down 70% since I wrote that?
RedHill was once a supplier of legacy products no one wanted. These products didn't sell too well, and the business was discontinued. In 2017, it acquired a pair of products from AstraZeneca (AZN) and privately held Cosmo, and started generating a good amount of revenue. Then, during the pandemic, RedHill rediscovered itself. It began developing reformulated old products, or old products with new delivery methods. Talicia was the first product of this kind that got approved. A combination of omeprazole magnesium, amoxicillin and rifabutin, Talicia treats Helicobacter pylori infection in adults. It is supposed to have a pretty large target market. Their next product in the pipeline was RHB-104 in Crohn's Disease, with positive phase 3 data in hand.
This was the state of RDHL in December last year when I covered it. They were a little low on cash, with about $50mn in hand at that time. So I was expecting a dilution, but I was not expecting a 70% depreciation in shareholder value in one year for what I had said was a staid, boring, low-risk stock.
Going through the news for the previous year, there are mainly two things that took the stock down. One of these is dilution. The other was euphoria surrounding covid-19, which was pushing the stock up until bad news came, and it collapsed. The company's covid candidate is opaganib, which began by showing promising results in animal studies, where it demonstrated a reduction of thrombosis in acute respiratory distress syndrome or ARDS in animal models. In December 2020, the company announced positive top-line safety and efficacy data from a Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia. This was followed by a number of Data Safety Monitoring Board (DSMB) recommendations to continue the Phase 2/3 study with orally-administered opaganib in patients hospitalized with severe COVID-19 trial, as planned. I note four of these DSMB reviews and recommendations.
Then in August the stock jumped hugely after preliminary results of a new preclinical study showed "strong inhibition by opaganib (ABC294640) of Delta variant replication while maintaining cell viability at relevant concentrations." However, that rally didn't last. This was just a preclinical study, however, in the real world phase 2/3 study, opaganib disappointed. In late August, early data from this study showed that ??opaganib treatment led to patients requiring less oxygen and earlier hospital discharge compared to those on placebo. However, by mid-September, topline data showed that the trial failed to reach statistical significance despite showing an efficacy trend. Key highlights:
Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.
Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced results from the U.S. Phase 2 study and the previously observed antiviral activity of opaganib.
The stock had started falling ever since the release of data on the medRxiv journal in late August. On this topline data failure, the stock price nearly halved. The company did try to find benefits "earlier in the course of the disease," however, the market seemed not to be buying that.
Going back to dilution, RDHL stock fell badly in November after the Israeli company announced an offering of American Depositary Shares. The stock fell 25% after announcing 4.7 million ADS valued at $15.5mn. There's no doubt they needed funds, but they announced a dilution from a position of weakness - after poor performance in the phase 2 trial. The market did not appreciate that. While RDHL has a solid business in its Moventik and legacy franchise, most of the euphoria surrounding the stock was from the covid-19 study. The failure of that trial took the stock down, and then there was the dilution - the stock hasn't recovered since, and I do not expect a quick recovery anytime soon.
Financials
RDHL has a market cap of $138mn and a cash balance of $51mn as of the September quarter. They also have a $80mn debt balance. Since then, they have raised an additional $15.5mn, but Research and Development expenses were $5.8 million for the third quarter of 2021, and SG&E was $24mn, so if that trend has continued, their current cash position would be somewhere in the range of $45mn.
The company, being an ADR, does not have insider transaction data available in the US. However, they did make two separate announcements about insider purchases. First was in September and mid-Oct, when the company's board and management together purchased 180,000 ADS. Then, just this month, insiders purchased another 66,000 ADS in the open market.
Besides, the company also raised more funds through a collaboration:
In November 2021, the Company announced that it had entered into a strategic agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of RedHill's American Depositary Shares (ADSs) in a private placement of up to $10 million, of which the first tranche of $5 million has been paid. As part of the agreement, the Company granted Kukbo a six month right of first offer for a license with respect to one or more of opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories.
Bottomline
RDHL is a complicated company with too many things going on at the same time, making it difficult for investors to figure out where to focus. They have their legacy products, they have the covid-19 program, and they have the rest of their pipeline. Taking all of these together, I think it is kind of dull that the market values it so low. RDHL looks like an aimless business with no defining characteristic, and what little it had in stability last year has been lost to the effort with covid-19 therapy. Right now, RDHL looks like a cul-de sac.
This article was written by
Avisol Capital Partners profile picture
Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Ascendiant Capital Adjusts Price Target on Redhill Biopharma
to $19 From $26, Maintains Buy Rating
LOL i wish. I'll take 50% happily!
https://www.marketscreener.com/quote/stock/REDHILL-BIOPHARMA-LTD-12243230/news/Ascendiant-Capital-Adjusts-Price-Target-on-Redhill-Biopharma-to-19-From-26-Maintains-Buy-Rating-37425993/
Life Sciences Companies Investor Presentations Now Available for On-Demand Viewing
https://finance.yahoo.com/news/life-sciences-companies-investor-presentations-133500214.html
Mon, December 20, 2021, 3:35 PM
Individual and institutional investors as well as advisors are invited to log-on to VirtualInvestorConferences.com to view presentations
NEW YORK, Dec. 20, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced that the presentations from the December 16th Life Sciences Virtual Investor Conference are now available for on-demand viewing.
This virtual event showcased live company presentations and interactive discussions focused on the life sciences industry. The company presentations will be available 24/7 for 90 days. Investors, advisors, and analysts may download shareholder materials from the company's "virtual trade booth".
REGISTER OR LOGIN NOW AT: https://bit.ly/3yxak8A
Participating Companies:
Presenting Company
Ticker(s)
RedHill Biopharma Ltd.
There cannot be anything new - they will come with same 70 page deck
Anyone listen? Anything new? Is a replay available?
RedHill Biopharma Announces Additional Insider Buying
Wed, December 15, 2021, 4:15 PM
https://investorshub.advfn.com/secure/post_new.aspx?board_id=26290
RALEIGH, N.C. and TEL-AVIV, Israel, Dec. 15, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, Mr. Dror Ben-Asher, collectively purchased approximately an additional 66,000 American Depositary Shares (ADSs) of RedHill since mid-October, in open-market transactions.
Well, it was good while it
lasted, about 30 seconds.
Virtual Conference for Life Sciences Companies Broadcast Live December 16th
Tue, December 14, 2021,
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 14, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(Nasdaq: RDHL)
10:00 AM
RespireRx Pharmaceuticals Inc.
(OTCQB: RSPI)
10:30 AM
Relief Therapeutics Holdings SA
(OTCQB: RLFTF | SIX: RLF)
11:00 AM
VolitionRx Limited
(NYSE AMERICAN: VNRX)
11:30 AM
Mind Cure Health Inc.
(OTCQX: MCURF | CSE: MCUR)
12:00 PM
Alpha Cognition, Inc.
(OTCQB: ACOGF | TSX-V: ACOG)
12:30 PM
Emmaus Life Sciences, Inc
(OTCQX: EMMA)
1:00 PM
Hemostemix Inc.
(OTCQB: HMTXF | TSX-V: HEM)
1:30 PM
Jack Nathan Medical Corp.
(OTCQB: JNHMF | TSX-V: JNH)
2:00 PM
ReShape Lifesciences Inc.
(NASDAQ: RSLS)
2:30 PM
Else Nutrition Holdings Inc.
(OTCQX: BABYF | TSX-V: JNH)
3:00 PM
Salarius Pharmaceuticals, Inc.
(Nasdaq: SLRX)
To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.
3.4900 +0.63 (+22.03%)
Pre-Market: 04:44AM EST
RDHL struck Gold?
You are most welcome Scrapiron,
hopefully we will get one day
properly rewarded!
Thanks for keeping us up to date!
RedHill Biopharma's Talicia Recommended For H. Pylori Infection
Vandana Singh
https://finance.yahoo.com/news/redhill-biopharmas-talicia-recommended-h-180528715.html
Thu, December 9, 2021, 8:05 PM
RedHill Biopharma Ltd (NASDAQ: RDHL) has announced the publication of a new study revealing concerning rates of widespread, physician-directed prescribing of clarithromycin-based regimens for H. pylori infection despite rising rates of antibiotic resistance and prior patient macrolide use.
The data were published in the journal Digestive Diseases and Sciences.
The publication notes that over 80% of all prescriptions for H. pylori infection are clarithromycin-based therapies, despite ACG recommendations to avoid clarithromycin triple therapy in patients with any prior macrolide use or in regions where the resistance rate is known to be 15% or above.
"Such failure rates and resistance have not been seen with Talicia," said Dr. Colin W. Howden, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center.
Since it does not contain clarithromycin, Talicia can be prescribed first-line without having to be concerned about local clarithromycin resistance, prior macrolide use, or patient CYP2C19 status," Dr. Colin added.
Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole).
In November 2019, Talicia was approved by the FDA to treat H. pylori infection in adults.
Life Sciences Virtual Investor Conference: Company Executives Present Live December 16th
Thu, December 9, 2021, 7:19 PM
RDHL
https://finance.yahoo.com/news/life-sciences-virtual-investor-conference-171900475.html
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 9, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(NASDAQ: RDHL)
10:00 AM
Life Sciences Virtual Investor Conference: Company Executives Present Live December 16th
Thu, December 9, 2021, 7:19 PM
RDHL
https://finance.yahoo.com/news/life-sciences-virtual-investor-conference-171900475.html
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 9, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(NASDAQ: RDHL)
10:00 AM
RedHill Biopharma: Concerning Rates of Clarithromycin Prescribing for H. pylori, Despite Increasing Antibiotic Resistance, Uncovered in New Digestive Diseases & Sciences Publication
https://finance.yahoo.com/news/redhill-biopharma-concerning-rates-clarithromycin-120000119.html
Despite increasing resistance to, and suboptimal H. pylori eradication rates with, clarithromycin, a new study, published in Digestive Diseases and Sciences, indicates that over 80% of all prescriptions for H. pylori infection contain clarithromycin
In addition, this analysis highlighted a nearly 40% failure rate for clarithromycin-based triple therapies in treatment-naïve patients; Study also showed a more than 80% failure rate in CYP2C19 rapid metabolizers, accounting for approximately 30% of Americans
Talicia, an FDA-approved therapy, is intended for first-line H. pylori eradication therapy
RALEIGH, N.C. and TEL-AVIV, Israel, Dec. 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication in the journal Digestive Diseases and Sciences of a new study entitled "Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data", revealing concerning rates of widespread, physician-directed prescribing of clarithromycin-based regimens for patients with persistent H. pylori infection despite rising rates of antibiotic resistance and prior patient macrolide use.
"The failure rate of clarithromycin-based therapy is alarming enough on its own. More alarming still is that more than 80% of all prescriptions for H. pylori infection are clarithromycin-based therapies – despite clear ACG recommendations to avoid clarithromycin triple therapy in patients with any prior macrolide use or in regions where the resistance rate is known to be 15% or above (or where resistance levels are not known)," said Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Such failure rates and resistance have not been seen with Talicia. Since it does not contain clarithromycin, Talicia can be prescribed first-line without having to be concerned about local clarithromycin resistance, prior macrolide use, or patient CYP2C19 status."
This study assessed prescribing patterns and associated cure rates of physician-directed therapy for subjects with persistent H. pylori infection after participation in either of two Phase 3 clinical trials (ERADICATE Hp and ERADICATE Hp2). The study also conducted CYP2C19 genotype analysis of subjects who were prescribed clarithromycin-based triple therapy. The most frequently selected treatments for physician-directed therapy from ERADICATE Hp and Hp2 were clarithromycin-based triple regimens (71.7%). Clarithromycin-based triple therapies across these studies showed eradication rates of approximately 60%, while rapid CYP2C19 metabolizers had eradication rates of less than 20%. This is clinically relevant because roughly one third of Americans have either rapid or ultra-rapid CYP2C19 metabolizer status[1]. Additionally, the study analyzed real world H. pylori retail prescription data, which revealed that the most frequently selected treatments for physician-directed therapy were clarithromycin-based triple regimens, accounting for more than 80% of prescriptions.
"This study highlights the need for a change in prescribing habits for H. pylori given rising resistance and the suboptimal eradication rates seen with clarithromycin-based regimens. This study demonstrated an approximately 60% eradication rate for clarithromycin-based therapies in treatment naïve patients[2], which is consistent with recently published eradication rates[3]," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. "Conversely, efficacy data from the two Phase 3 studies demonstrated eradication rates of approximately 89% in the ERADICATE Hp mITT population and 90% in the ERADICATE Hp2 adherent population for Talicia in treatment-naïve subjects, identified no primary or acquired resistance to rifabutin and found that cure rates were largely unaffected by CYP2C19 metabolic status."
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[4] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[5].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[6] of the U.S. population, with an estimated two million patients treated annually[7]. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[12].
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[13], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[14], and Aemcolo® for the treatment of travelers' diarrhea in adults[15]. 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 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.
About Talicia® (omeprazole magnesium, amoxicillin and rifabutin)
INDICATION AND USAGE
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Severe cutaneous adverse reactions (SCAR) (e.g. Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com
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 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 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 & 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
Category: R&D
[1] Ionova Y, Ashenhurst J, Zhan J et al. CYP2C19 allele frequencies in over 2.2 million direct-to-consumer genetics research participants and the potential implication for prescriptions in a large health system. Clin Transl Sci. 2020;13:1298–1306 https://doi.org/10.1111/cts.12830
[2] mITT population who failed placebo as primary treatment, who entered into physician directed care phase
[3] Argueta, E. A., Alsamman, M. A., Moss, S. F., & D'Agata, E. M. C. (2021). Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology, 160(6), 2181-2183 e2181. https://doi.org/10.1053/j.gastro.2021.02.014
Malfertheiner, P., Megraud, F., O'Morain, C. A., Atherton, J., Axon, A. T., Bazzoli, F., Gensini, G. F., Gisbert, J. P., Graham, D. Y., Rokkas, T., El-Omar, E. M., Kuipers, E. J., & European Helicobacter Study, G. (2012). Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut, 61(5), 646-664. https://doi.org/10.1136/gutjnl-2012-302084
O'Connor, A., Gisbert, J. P., O'Morain, C., & Ladas, S. (2015). Treatment of Helicobacter pylori Infection 2015. Helicobacter, 20 Suppl 1, 54-61. https://doi.org/10.1111/hel.12258
Venerito, M., Krieger, T., Ecker, T., Leandro, G., & Malfertheiner, P. (2013). Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion, 88(1), 33-45. https://doi.org/10.1159/000350719
[4] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[5] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
[6] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[7] IQVIA Custom Study for RedHill Biopharma, 2019
[8] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[9] NIH – Helicobacter pylori and Cancer, September 2013.
[10] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[11] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[12] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
[13] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[14] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[15] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-concerning-rates-of-clarithromycin-prescribing-for-h-pylori-despite-increasing-antibiotic-resistance-uncovered-in-new-digestive-diseases--sciences-publication-301441040.html
SOURCE RedHill Biopharma Ltd.
shouldn’t we sell more shares at 6 and raise twice as much or at 12 and raise 4 times as much
In hindsight, sure. The decision when is always a
tough one. On one hand RDHL has some cash, on the
other the company has a hefty cash burn amount due
to various trials and activities.
In short your question is good, but more like in the
category of: Could have, should have, would have .
Thanks midas but if we have cash to last a while, shouldn’t we sell more shares at 6 and raise twice as much or at 12 and raise 4 times as much or sell less shares and dilute less? Makes no sense to me but I’m holding anyway - only 4,000 shares
1) why aren’t we much higher?
Disappointment from company lack of performance
coupled with general bio underperformance:
Big-name biotech hedge funds have_been_hammered_ this_ year:
https://www.wsj.com/articles/hedge-funds-suffer-big-losses-on-biotech-rout-11638727155
Quote:
Perceptive Advisors, a prominent biotech hedge fund that manages about $9 billion, lost about 30% this year through November in its main fund, investors say. A hedge fund managed by OrbiMed Partners, which invests more than $18 billion in healthcare in public and private markets, has lost more than 40% this year through November…
…The SPDR S&P Biotech ETF (XBI), an equal-weighted index of biotech stocks, has fallen about 22% so far this year through Friday, and is down 37% from its Feb. 8 peak.
Unquote
2) why did we issue more shares to raise money and cause unecessary dilution?
Companies raise whenever they can, not necessarily when they need.
Am i happy? No, but i still hold my shares!
Listening to the conference call now
As of 9/30/21, we had over $51 million and had $21 million in revenues.
2 questions
1) why aren’t we much higher?
2) why did we issue more shares to raise money and cause unnecessary dilution?
RedHill Biopharma says its experimental oral COVID-19 drugs not affected by Omicron
Dec. 06, 2021 9:00 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor2 Comments
RedHill Biopharma (NASDAQ:RDHL) announced that the newly detected Omicron variant of the coronavirus is unlikely to impact its experimental COVID-19 therapies, Opaganib and RHB-107.
Opaganib developed for hospitalized patients with the advanced form of the disease, targets the human host cell rather than the virus, and, therefore, it is “not expected to be impacted by spike protein mutations,” the company said.
While COVID-19 pills developed by Pfizer (NYSE:PFE) and Merck (NYSE:MRK) require a 3-5-day period to begin their treatments following the onset of symptoms, Opaganib is started at a median of 11 days following the beginning of symptoms.
In a regulatory update, RedHill (RDHL) said that Phase 2/3 data for Opaganib have been submitted to the European Medicines Agency (EMA) and the FDA with initial feedback from two regulatory agencies expected by the end of the year and January 2022, respectively.
The data submissions have already been made to the UK (MHRA), and the regulatory submissions to several other countries, including South Africa, Russia, and Israel, are also lined up.
Topline data from Part A of its Phase 2/3 study for RHB-107 in non-hospitalized patients is expected in Q1 2022.
Read more on upcoming milestones for RedHill (RDHL) as announced by its management last month.
RedHill Biopharma Reports that Opaganib Mechanism Not Impacted by Viral Spike-Protein Mutations, Including Omicron Mutations
https://finance.yahoo.com/news/redhill-biopharma-reports-opaganib-mechanism-120000685.html
Unique Mode of Action
Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron SARS-CoV-2 variant, as well as other variants of concern
Regulatory update
Opaganib global Phase 2/3 data packages submitted to European EMA, with initial feedback expected by end of year, to the U.S. FDA with initial feedback expected in January, and to the UK MHRA, with other countries lined up
A number of pending grant applications in the U.S. and abroad with both government bodies and non-government entities
Opaganib designed for underserved hospitalized patient population with advanced disease; Opaganib treatment initiated a median of 11 days from symptom onset in the Phase 2/3 global study, compared to the limited 3-5-day from symptom onset scope of the Pfizer & Merck pills
RHB-107, RedHill's other oral COVID-19 drug candidate, expected to deliver top-line data in Q1/2022 from Part A of its Phase 2/3 study in non-hospitalized patients in the U.S. and South Africa; RHB-107 also not expected to be impacted by spike protein mutations
TEL AVIV, Israel and RALEIGH, N.C., Dec. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that because opaganib's[1] proposed mechanism of action is not impacted by spike protein mutations, opaganib is expected to be unaffected by mutations associated with Omicron and other known variants of concern. The Company also provided an update on the status of its regulatory submissions for opaganib.
Increased hospitalizations in South Africa due to Omicron highlight the urgent need for drugs aimed at moderately severe COVID-19 patients with pneumonia requiring hospital treatment. By focusing on this large group of patients, opaganib, if approved, would target an entirely different and sicker patient population than the Pfizer and Merck oral drug candidates, which showed benefit only in non-hospitalized patients at the earliest stages of symptomatic infection.
Opaganib acts independently of mutations to the viral spike protein. We believe that its unique proposed mechanism of action - targeting a protein in the human cell required by the virus for replication rather than the virus itself - holds significant potential versus Omicron and other existing and emerging variants with mutations to the spike protein. Extensive clinical and non-clinical data support the rationale for accelerating this program, including clinical data from Phase 2 and Phase 2/3 studies, compassionate use experience and strong inhibition against variants of concern, including Delta.
"Omicron is just another reminder that COVID-19 is an endemic virus at this point, and it is not going away. The evolution of this virus will continue as long as it circulates, and we will need to continue to tweak our vaccines and monoclonal antibodies in order to respond to new variants as they arise. Most importantly, this underscores the need for safe and effective anti-viral therapies that will continue to work no matter which variants present themselves. It is vital that focus, time and resources are given to the development of anti-viral therapies that can effectively treat those COVID-19 high risk patients, preferably without concern for variants and mutations," said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University. "The post-hoc data from the opaganib Phase 2/3 study in moderate and severe COVID-19 patients is intriguing and suggests the possibility that opaganib might prove itself as an effective anti-viral in this setting. In a subpopulation of patients defined as moderately severe based on their level of baseline oxygen supplementation, mortality was 62% lower in those using opaganib (16% placebo Vs. 6% opaganib). The results suggest a sub-group of patients who would likely benefit from this therapy, and they highlight the need for additional studies in the development of this therapy."
Regulatory & Development Update:
Given the promising clinical results to-date in the moderately severe hospitalized patient population in a large subpopulation analysis of the global Phase 2/3 study, RedHill is vigorously pursuing the development program for opaganib:
Submitted data packages to the U.S. FDA, the European Medicines Agency (EMA) and the UK (MHRA) actively seeking scientific advice on the potential path towards approval of opaganib. The EMA has indicated a rapid procedure timeline, and we expect their advice by end of the year, with preliminary feedback from the FDA expected in January 2022.
Pursuing submission in other countries including South Africa, Russia, Israel, Switzerland, India, Brazil and Colombia.
Discussions and preparation ongoing for a confirmatory study with opaganib in the targeted moderately severe hospitalized patient group, engaging with the FDA, other regulatory bodies as well as other government agencies on the need to further accelerate development of much needed therapeutics, such as opaganib and RHB-107, against Omicron and emerging variants.
A number of pending grant applications in the U.S. and abroad with both government bodies and non-government entities.
"Both opaganib and RHB-107 have unique human cell-targeted mechanisms of action that act independently of mutations at the spike protein. Given the gravity of the threat presented by Omicron, and the likely emergence of other variants, RedHill is pursuing development of these two promising COVID-19 pills as quickly and diligently as possible. We have extensive safety data and, in the case of opaganib, an apparent clinical benefit in reducing mortality, getting patients back onto room air and getting them out of hospital faster," said Gilead Raday, RedHill's Head of R&D "Importantly, opaganib benefited a population of hospitalized patients in moderately severe condition with treatment being initiated a median of 11 days from the onset of symptoms in our Phase 2/3 global study. This distinguishes opaganib as a potential game-changer for advanced COVID-19 patients who are at a significant risk of dying from their condition and already well beyond the 3-5-day from symptom onset scope offered by the Pfizer and Merck anti-viral pills."
Unique Opaganib Proposed Mechanism of Action:
Opaganib is a sphingosine kinase-2 (SK2) inhibitor, a promising and differentiated approach that targets the SK2 human host cell factor rather than the virus itself, working independently of spike protein mutations, such as those associated with Omicron and emerging variants of concern. SARS-CoV-2, the virus which causes COVID-19 disease, is a positive-sense single-stranded RNA (+ssRNA) virus, which account for more than one-third of all known virus genera. These viruses use host factors in various steps of viral infection, such as cell entry and replication - SK2 is one such factor, potentially making it a broad-spectrum antiviral target. SK2 is also active in the modulation of certain pro-inflammatory cytokines, with in vivo studies demonstrating opaganib's potential to ameliorate inflammatory lung disorders and decrease renal fibrosis by reduction of IL-6 and TNF-alpha levels in bronchoalveolar lavage fluids. Thus, inhibition of SK2 may deliver a 2-pronged antiviral and anti-inflammatory effect – a highly desirable mechanism in the case of COVID-19. Moreover, opaganib's targeting of SK2 and not the virus itself, means it is expected to uphold antiviral activity irrespective of the worrisome mutations in the SARS-CoV-2 spike protein and the emergence of new strains, such as Omicron, which may be evasive of direct antiviral antibodies and vaccines.
RHB-107 Mode of Action and Development Status
RHB-107[2], RedHill's other oral COVID-19 drug candidate, is a once-daily oral capsule, given early in the course of the disease, to outpatients. It targets Serine Proteases, which are human enzymes that are involved in facilitating the entry of SARS-CoV-2 into target cells. The cleaving of the spike protein by these host human serine proteases, is a necessary step in viral attachment and entry into the cells, which is independent of the mutations observed in the Omicron variant that are altering the spike-protein antigenic properties.
RHB-107 is currently being evaluated in a Phase 2/3 study in non-hospitalized COVID-19 patients in the U.S. and in South Africa. Recruitment for part A of the study has been completed and top-line results are expected in the first quarter of 2022.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of all SARS-CoV-2 variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib's potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature. The Company intends to further examine the data from this study in greater detail, along with all the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings which are new or inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the analyses reported in this release as the final definitive results of the study.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study, in the U.S. and South Africa, for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
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[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. 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 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/ 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 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 regulatory feedback regarding the Phase 2/3 data packages submitted to the regulatory authorities, the risk of a delay in top-line data from Part A of the Phase 2/3 study of once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19, the risk that further analysis of the top-line results of the Phase 2/3 COVID-19 study for opaganib results in findings inconsistent with the data disclosed in this release; that no further COVID-19 studies for opaganib will be commenced, and if commenced, may not be successful, including with respect to moderately severe COVID-19 and patients in earlier stages of COVID-19 on low flow oxygen support; that any additional studies for opaganib in COVID-19 patients, even if successful, will not be sufficient for regulatory applications, including emergency use or marketing applications, that 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 will be required by regulatory authorities to support such potential applications and the use or marketing of opaganib or RHB-107 for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical 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 preclinical studies or clinical trials (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 Movantik®, Talicia® and Aemcolo®; (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 and sustain 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, preclinical 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 commercial products 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 events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. 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 & 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
Category: R&D
[1] Opaganib is an investigational new drug, not available for commercial distribution.
[2] RHB-107 is an investigational new drug, not available for commercial distribution.
[3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
[4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
SOURCE RedHill Biopharma Ltd.
RedHill Bio gains 6% after Talicia shows efficacy in eradicating H. pylori infection
Dec. 02, 2021 7:41 AM ETRedHill Biopharma Ltd. (RDHL)
By: Mamta Mayani, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announces the publication of a new study in the journal GastroHep, showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical trials.
RDHL shares up 6.3% premarket at $2.89.
This new publication, describing a post-hoc analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials showed that Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001).
Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m treated with Talicia achieved eradication rates of ~90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively – the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.
No cases of rifabutin resistance were identified in this study.
Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.
H. pylori is a bacterial infection that affects ~35% of the U.S. population
RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI
https://finance.yahoo.com/news/redhill-biopharma-data-published-gastrohep-120000559.html
High Body Mass Index and obesity are known risk factors for H. Pylori eradication treatment failure; Newly published data in GastroHep shows high eradication rates for Talicia® across BMI groups
Data from a post-hoc analysis showed H. pylori eradication rates with Talicia of 88.1% and 90.9% in patients with BMI> 30/<40kg/m2 and in patients with BMI>40 kg/m2, respectively, versus active comparator rates of 62.9% and 31.8% respectively - an almost 50% difference in efficacy from the active comparator in the severely obese group
Talicia, an FDA approved therapy, may be used as first-line H. pylori eradication therapy
TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces the publication of a new study entitled "Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep, showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical trials.
This new publication, describing a post-hoc analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials who had BMI >30 kg/m2, showed that Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively – the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.
"High BMI and obesity are known risk factors for H. Pylori eradication treatment failure[1]. Data from previous studies[2] have shown that the failure rate of clarithromycin triple therapy can increase by nearly 300% in patients with high BMI, from nearly 15% in patients with BMIs<25 kg/m2 to 45% in subjects with BMIs≥25 kg/m2," said Prof. John Yung-Chong Kao, MD, Professor of Internal Medicine, Division of Gastroenterology, University of Michigan, and lead author of the paper. "With more than 70% of American adults being overweight or obese, it is important to understand the influence of patient BMI on H. pylori eradication treatment success. These data support that low-dose rifabutin-containing therapy such as Talicia can be considered as a first line therapy to treat H. pylori infection particularly in patients with high BMI."
No cases of rifabutin resistance were identified in this study, compared to a pooled clarithromycin resistance rate of more than 17% seen across all BMI groups, which highlights the potential risk of empirically prescribing clarithromycin-containing regimens for the treatment of H. pylori. Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.
"The obese population experiences more infections and thus has more antibiotic exposure than the general population, potentially leading to higher rates of antibiotic-resistant organisms," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer." Given the medical risks associated with obesity, it is especially important to use highly effective treatments such as Talicia, to provide patients with a high probability of cure with first-line treatment."
RedHill Biopharma's Movantik® Added as Preferred and Unrestricted Brand To Major National Medicare Formulary Serving Millions of Americans
https://finance.yahoo.com/news/redhill-biopharmas-movantik-added-preferred-122200874.html
Movantik® approved for inclusion as preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans as of January 1, 2022
Movantik's total commercial coverage extends to 152 million American patients' lives and will grow to 46 million Medicare lives and will increase to over 94% coverage of Medicare Part D lives
Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain
TEL AVIV, Israel and RALEIGH, N.C., Dec. 1, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving more than 10 million Americans through multiple Medicare plans, has approved the inclusion of Movantik® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation, as a preferred and unrestricted brand on its National Medicare Part D formulary starting January 1, 2022.
"It is important for optimal chronic pain treatment that patients are able to manage the debilitating constipation that often accompanies opioid therapy and have access to treatments such as Movantik," said Rick Scruggs, RedHill's Chief Commercial Officer. "This important new listing for Movantik, the market-leading PAMORA for opioid-induced constipation, as a preferred and unrestricted brand on a major National Medicare Part D formulary provides that access to more than 10 million more Americans covered by this formulary. Movantik now has coverage of 90% of U.S. commercial lives and will increase to over 94% coverage of Medicare Part D lives, as we continue our efforts to increase patient access to Movantik."
About Movantik® (naloxegol)
Movantik® is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Important Safety Information About Movantik
Movantik® (naloxegol) is contraindicated in:
Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.
Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.
Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).
Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Click here for the Medication Guide and full Prescribing Information for Movantik.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
RedHill Biopharma's (RDHL) CEO Dror Ben-Asher on Q3 2021 Earnings Call Transcript
Nov. 30, 2021 4:09 PM ETRedHill Biopharma Ltd. (RDHL), REDIF1 Comment
Q3: 2021-11-30 Earnings Summary
EPS of -$0.05 beats by $0.23 | Revenue of $21.61M (3.18% Y/Y) misses by $1.79M
RedHill Biopharma Ltd. (NASDAQ:RDHL) Q3 2021 Earnings Conference Call November 30, 2021 8:30 AM ET
Company Participants
Alexandra Okmian - Senior Business Development and IR Manager
Dror Ben-Asher - CEO
Guy Goldberg - Chief Business Officer
Gilead Raday - COO
Rob Jackson - SVP, Sales and Marketing
Micha Ben-Chorin - CFO
Bob Gilkin - SVP, Market Access and Trade Relations
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
Boobalan Pachaiyappan - H.C. Wainwright
David Hoang - SMBC
Robert Hazlett - BTIG
Scott Henry - ROTH Capital
Operator
Good day and thank you for standing by. Welcome to the RedHill Biopharma's Third Quarter 2021 Results Financial 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; 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; Bob Gilkin, Senior VP, Market Access and Trade Relations; and Dr. June Almenoff, Chief Medical Officer.
Before we begin, we will read from the RedHill's Safe Harbor statement. Please go ahead.
Alexandra Okmian
Thank you, Brian. 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 18th, 2021 and in its other filings with the Securities and Exchange Commission.
Dror Ben-Asher
Thank you, Alexandra. Good day everyone and thank you for joining our third quarter earnings call. Today, we'll be presenting detailed R&D, commercial, and financial highlights.
In light of the recent emergence of the Omicron variant and the risk presented by future variants of concern, we will elaborate on RedHill's strategy with opaganib and RHB-107 and our increasingly irrelevant mechanisms of action potential against the emerging variants.
Our U.S. commercial business continues to drive growth, reiterating a second consecutive quarter in net revenue record of $21.6 million despite continuously challenging pandemic environments.
Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform, adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. Rob Jackson, who is heading out Marketing and Sales will further elaborate shortly.
Turning to R&D, given the recent emergence of the heavily mutated Omicron or South African variant, as well as likely emergence of other variants of concern over time, the importance of drug candidates that are independently of the viral spike protein is growing.
This makes both opaganib and RHB-107 host targeted mechanism of action and expected maintenance of effects against new variants, increasingly more relevant in the battle against COVID-19.
The third quarter saw significant focus on completing opaganib's global Phase 2/3 COVID-19 study in hospitalized patients. Specifically in the currently underserved hospitalized moderately severe patient group, which the Pfizer and Merck do not address.
A sub-population comprising more than 50% of our total study population, opaganib demonstrated a 62% reduction in mortality, as well as improved return to room air and area hospital discharge.
This is consistent with what we have seen in our Phase 2 study and compassionate use experience. The consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population.
We have now provided regulators in various countries with robust data packages to facilitate discussions on next steps and we'll continue to provide data to regulators in additional countries.
Expedited review of the opaganib data has already been granted by EMA, the European Union's regulatory body equivalent to the FDA in United States. In parallel lance, we continue to progress our Phase 2/3 program in non-hospitalized patients in the United States and South Africa, with our other novel once-daily oral COVID-19 drug candidate RHB-107. We passed a topline results expected in the first quarter of 2022. Gilead, our Chief Operating Officer will elaborate about the status of our COVID-19 programs shortly.
Our Phase 3 study of RHB-204 in pulmonary NTM disease continues to enroll patients in the United States. Importantly, progress with Phase 3 stage RHB-104 for Crohn's disease is expected to speed up, thanks to a recent much awaited potential progress in Mycobacterium avium subspecies paratuberculosis or in short, MAP detection research. We're very excited about that.
With steep reduction in quarterly operating and net loss, a quarterly record gross profit of $12.4 million with improved gross margin from net revenues and a potential commercial non-GAAP EBITDA breakeven before the end of the year, along with advanced, exciting, and timely R&D pipeline, we are well-positioned for short, medium, and long-term success as an emerging specialty pharma company.
Before turning to our Chief Business Officer, Guy Goldberg and the rest of the team for our presentation, please remember to press the link in order to view our detailed slides to be followed by a Q&A session.
Guy Goldberg
Thank you, Dror. As we near the end of the year, RedHill is at a very important point. I will start with the bottom of the side, focusing on RedHill's pandemic program with Omicron and the potential for future variants dominating the attention of public health officials, what they have been saying loud and clear is that a simple, scalable, effective, and safe therapeutic is desperately needed.
As we all know, the hope that vaccines alone will get us out of this pandemic will most likely not become reality. RedHill is uniquely positioned to make a difference with its two oral COVID vaccine -- sorry two oral COVID therapeutic candidates.
First, opaganib, our novel orally administered first-in-class SK2 inhibitor addressing the moderately severe in-patient hospitalized population. With its method of action targeting the host cell rather than working on the virus directly, which we believe we can cast a wider that of efficacy against emerging variants such as the Omicron variant.
We have conducted two clinical studies, a Phase 2 and a Phase 2b study in hospitalized COVID patients, both demonstrating the potential of opaganib and Gilead will provide more detail of the Phase2/3 study that is the focus of our submissions in several countries around the world.
These submissions open up a potentially milestone-rich upcoming few months as we get feedback from these regulatory agencies as far as next steps. Gilead will also provide important new updates later in the presentation of the timelines for regulatory feedback as well as new biomarker data and support that are post-hoc analysis as identified the correct target population for opaganib.
Second, we have RHB-107 or upamostat, an orally-administered inhibitor, a best one family of trypsin-like serine protease, being developed as a treatment for non-hospitalized COVID patients.
upamostat has demonstrated protein inhibition of SARS-CoV-2 viral replication in preclinical model of human bronchial tissue. And there's -- as a result of prior development in a number of indications in several clinical studies, we also have a critical safety profile from approximately 200 patients. We are conducting a Phase 2/3 study non-hospitalized COVID-19 patients in the U.S. and South Africa and we have completed recruitment for Part A of the study and expect topline results in Q1 2022.
Importantly, RHB-107 is also a once-daily oral pill and is also host mediated, which means that it should also potentially work against various mutations, such as Omicron. Also importantly patients in the study are tested for specific viral strain.
Returning down to the top part of the slide in our financial highlights from Q3. On the commercial side, we generated record quarterly revenues despite industry-wide challenges that we believe we will see growth throughout the end of the year and into next year.
As a small company, we continue to stand the test of the pandemic and prove we are a resilient organization. To this, we generated 50% quarter-over-quarter growth, commercial coverage continues to improve, and we continue to achieve important launch milestones that will be covered later in the presentation.
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 payers and also exhibitions.
With Movantik, we continue to maintain our market leader position. Movantik is well-liked by physicians that it's great reimbursement, great efficacy and safety, and great brand recognition satisfaction. There's still a very large and underserved OIC patient population and RedHill continues to improve of Movantik's status of best unrestricted coverage in the PAMORA class.
Finally, we've maintained a cash position of $51.5 million as of September 30th to support our R&D and commercial efforts.
I would like to provide a brief overview of RedHill to those new to the story who may be on our call today. RedHill is a fully integrated specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, with a robust pipeline of drugs and a world-class commercial operation right out of our headquarters, U.S. headquarters in Raleigh, North Carolina.
At the top of this slide, you see the three FDA approved drugs we promote, Movantik for opioid-induced constipation; Talicia for H. pylori infection; and Aemcolo for travelers' diarrhea caused by non-invasive strains of E. coli. Rob Jackson, our Senior VP for Marketing and Sales will be going into detail of the commercial efforts.
The second part of the slide shows the multiple late-stage programs in development addressing important unmet medical needs. Gilead Raday, our Chief Operating Officer will review our two COVID programs that I just mentioned. I will then provide an update on RHB-204 two for NTM disease and RHB-104 for Crohn's disease.
I will now turn it over to Gilead.
Gilead Raday
Thank you, Guy. In the following slides, I will provide an overview of our advanced COVID-19 programs, specifically with respect to the promise for addressing the Omicron variant and the growing concerns due to potential emergence of resistance to current vaccines and antibodies. I will also provide further data and analyses from the global Phase 2/3 study, some of which has not been shared before, which bolster our previous reporting of an apparent meaningful benefit of opaganib to the survival of moderately severe hospitalized COVID-19 patient.
As a reminder, opaganib is an oral pill, which is a first-in-class proprietary selective sphingosine kinase-2 inhibitor. Through inhibiting this host factor enzyme, opaganib exerts a dual action against COVID-19, inhibiting viral replication on the one hand and reducing the body's excess immune response to the infection on the other hand.
Preclinical efficacy has been demonstrated in numerous anti-inflammatory and anti-viral models, including demonstrating the blocking of SARS CoV-2 viral replication across several variants in human bronchial tissue.
Multiple Phase 2 studies and compassionate use in COVID and non-COVID indications have shown promising signals of activity and safety in hospitalized patients.
The recently completed global Phase 2/3 study in COVID-19 show opaganib's apparent benefit to the survival of hospitalized COVID-19 patients in moderately severe condition. These are patients with COVID-19 pneumonia, who require supplemental oxygen of up to 60% fraction of inspired oxygen, or FIO2 in short.
These patients represent a large underserved COVID-19 patient population, which the Pfizer and Merck pills do not address. The hospitalized patient population that opaganib benefited in the study was far more advanced in disease progression than the early stage outpatients which participated in the Pfizer and Merck studies.
opaganib benefited a population of hospitalized patients in moderately severe condition, with a median of 11 days from the onset of symptoms. While the Pfizer and Merck studies were limited to outpatients with a maximum duration of five days from onset of symptoms.
This distinguishes opaganib as a potential game changer for advanced COVID-19 patients who has a high risk of dying from the condition and are already well beyond the realm that the Pfizer and Merck pills can target.
Importantly, opaganib's mechanism of action is independent of the Omicron variant spike protein mutations, which are raising global concerns regarding its potential to evade vaccines and antibodies.
opaganib's anti-viral effect is on the intracellular process of viral replication. At the replication transcription complex, this takes place downstream from the viral attachment to the cell membrane and viral entry into the cell. As such opaganib's activity which blocks the replication of the virus inside the cells isn't impacted by changes in the viral envelope.
Specifically, changes in the spike protein are of no direct consequence to opaganib's pathway. opaganib's proposed anti-viral activity is hence expected to be fully maintained against the Omicron variant and also against other future foreseeable spike protein variants of concern.
In a similar fashion, opaganib's proposed anti-inflammatory activity is also independent of Omicron variant spike protein mutations. The reduction in inflammation due to opaganib's inhibition of SK-2 is not directly related to the SARS CoV-2 virus, but rather to the body's immune responses. As such opaganib's anti-inflammatory activity is also expected to be fully maintained against the Omicron variant and against other potentially emerging variants of concern.
opaganib's capacity to work against Omicron and other future variants through both its anti-viral and its anti-inflammatory modes of action, position it in a unique and high priority potential COVID-19 therapy potential.
The reason we are excited about opaganib's potential central role in treating COVID-19 is the apparent benefit of opaganib in reducing mortality of advanced hospitalized COVID-19 patients in moderately severe condition, patients requiring a level of oxygen supplementation of up to 60% fraction of inspired oxygen or FIO2.
In our global Phase 2/3 study, this patient population consisting of 251 subjects showed a significant 62% reduction in mortality events when treated with opaganib with a nominal P value of 0.019. The mortality rate in the control arm was 15.7%. indicative of the high risk of such patients dying due to the serious condition they were in.
Treatment of these patients with opaganib reduced the mortality risk to 6%, a very meaningful potential to save lives. The Kaplan Meier curves of time to mortality event in this hospitalized patient population, show a clear separation, beginning from a few days after treatment initiation and carry through to the end of the follow-up period of day 42.
Supporting the critically important benefits of the survival of patients, additional key clinical outcomes showed a consistent benefit of opaganib for this patient population. 76.9% of opaganib-treated patients were weaned from their oxygen support, and were able to breathe room air by day 14 versus 63.4% of placebo, an efficacy benefit, with nominal P value of 0.033.
Consistent with these findings, other key secondary endpoints also showed an apparent benefit of opaganib in this hospitalized patient population with nominally significant P value. A clinical improvement of two or more points on the WHO ordinal scale by day 14 showed a meaningful difference with approximately 80% clinical improvements in the opaganib treated arm versus 66% in the control arm with nominal P value of 0.023.
Similarly, the time to clinical improvement, down to a score of three or lower from a baseline score of five on the WHO ordinal scale was shorter for patients treated with opaganib with a median of eight days versus 10 days and a P value of 0.01.
Patients treated with opaganib were also discharged earlier from hospital with a mean difference of approximately four and a half fewer days in hospital with a nominal P value of 0.022.
The consistency of opaganib's benefits across the various clinical outcomes evaluated strengthens the inference the clinical benefit is not a one-off statistical finding as the result of a specific measurement.
Further supporting the apparent overall benefits of survival, opaganib's benefits in this population of patients was consistent across the territories participating in the study, in Europe, Latin America, Israel, and Russia, demonstrating that the survival benefit was not driven by any territorial outliers.
To ensure that the clinical benefits is not a result of potentially confounding risk factors, a comprehensive analysis of the potential confounders was conducted. As can be seen, an exhaustive list of such potential confounders was analyzed. This analysis demonstrated clearly that the survival benefit remains consistent and high within a range of 59% to 66% survival benefit, irrespective of potentially confounding risk factors, including such major known factors, such as age, sex, diabetes, BMI, or use of dexamethasone as underlying standard of care.
In recent analysis of the inflammatory biomarkers of the opaganib study subjects, which we are sharing publicly today for the first time, further substantiates and supports the utility of FIO2 is a valuable indicator of COVID-19 disease severity, and also as a potential predictor of a treatment benefit with opaganib in this target population of hospitalized patients.
This table shows that known and accepted disease severity indicating markers such as CRP, lymphocyte counts, and D-Dimer are in close correlation in agreement with FIO2. This demonstrates with very significant nominal P values as shown in the rightmost column. That the group of patients characterized as requiring lower FIO2 at baseline that is up to 60% FIO2, are indeed a distinct group of hospitalized patients exhibiting lower levels of severity markers than those patients that required higher than 60% FIO2 oxygen at baseline.
This recent analysis that was not previously publicly announced further supports the overall framework of the FIO2 based analysis of study outcomes. It supports using FIO2 as an indicator of the severity and as a potential identifier of the patient population that stands the best chance of significantly benefiting from being treated with D-Dimer.
The analysis of safety outcomes shows that safety events in the study were similar between treatment arms, with no new safety concerns emerging. The majority of the TEAEs were mild to moderate in severity. Serious TEAEs were experienced by 52 out of 230 patients in the opaganib arm versus 52 out of 233 patients in the placebo arm similar ratios.
TEAEs with an outcome of death occurred in 15.7% versus 17.2% in the opaganib and placebo arms respectively. The excellent safety results supports the overall risk benefit evaluation of opaganib in this patient population, and is expected to be an important component in regulatory considerations going forward.
Acknowledging that the analysis of the study that demonstrates the apparent benefits for the moderately severe patient population was conducted post-hoc, it is important to clarify why we have a high degree of confidence that this outcome is not a statistical artifact, inferring that opaganib may indeed be effective in this population.
The framework of the post-hoc analysis which identified a subpopulation showing a meaningful benefit when treated with opaganib is strongly supported by the following aspects. FIO2, which is a parameter used to identify population is a clinically and medically relevant parameter for capturing oxygen requirements of patients and for indicating disease severity. This conjecture is now strongly supported by the correlation of FIO2 with known and accepted inflammatory biomarkers of disease severity.
Consistency of opaganib's apparent benefits across the different clinical endpoints strengthens the likelihood that the outcome of any one particular endpoint is not a statistical artifact. The consistency of opaganib's apparent benefit across the study territories provides additional support showing the effect seen or not driven by any particular territorial outlier.
Further, while not shown in this presentation, we also tested the consistency of paganism added benefit using different oxygen supplementation cutoff points, for example, FIO2 of 50% instead of 60%. This analysis confirmed that the benefit for the lower oxygen supplementation patients, which reflects lower severity of patients is maintained irrespective of the precise cutoff point selected, again, reducing the likelihood that the analysis is a statistical artifact and supporting the assertion that there's a correlative relationship between lower severity of disease and opaganib's capacity to benefit the patients.
Finally, as presented earlier, opaganib's apparent benefit is not dependent on baseline risk factors or potential confounders showing that opaganib is the likely factor underlying the differences in outcomes for the treated patient.
Given all this, despite the analysis being post-hoc, the thoroughness of this analysis provides a high degree of confidence that the apparent benefit is not a statistical artifact and opaganib may be safe and effective in this underserved hospitalized COVID-19 patient population.
The resurgence of concerns that Omicron variant might show resistance to vaccines and antibodies further highlights the urgency and the potential advantages of opaganib's potential effectiveness against such variants.
To update on the regulatory status, we have filed opaganib data package in key territories worldwide and continue to file in additional countries. We are anticipating regulatory guidance for next steps in the targeted hospitalized COVID-19 patients population where there is no currently effective treatment.
Europe's EMA has indicated rapid procedure timelines with preliminary feedback expected by year end. Preliminary feedback from the U.S. FDA is expected in January 2022. Additional territories pursued are the U.K., Russia, Brazil, Israel, Switzerland, Colombia, India, and South Africa. We're also making plans for a confirmatory study with opaganib in the targeted moderately severe hospitalized patients.
Subject to regulatory feedback, we will consider shifting from the current standards of our declassifications based on the World Health Organization Ordinal Scale, which utilizes the type of oxygen delivery device to define in COVID-19 pneumonia severity using FIO2 as the key parameter.
Moving over to a quick update on RHB-107 or upamostat, our second COVID-19 novel oral program that is currently being evaluated in a Phase 2/3 study in non-hospitalized COVID-19 patients in the U.S. and in South Africa.
RHB-107 is a once-daily oral capsule given early in the course of the disease to outpatients. It targets serine proteases, which are human enzymes that are involved in facilitating the entry of SARS CoV-2 into target cells. The cleaving of the spike protein by the host human serine proteases is a necessary step in viral attachment and entry into the cells, which is independent of the mutations observed in the Omicron variant that are altering the spike protein antigenic properties.
As such RHB-107 is expected to be insensitive to mutations in spike protein, given its host mediated mechanism of action. RHB-107 has demonstrated inhibition of SARS CoV-2 viral replication in preclinical model of human bronchial tissue and is currently being evaluated in outpatients with symptomatic COVID-19 in the U.S. in South Africa.
Recruitment for part A of the study has been completed and topline readout is expected in Q1 2022. We plan to also analyze variants and we'll plan to include the Omicron variants of concern in the study analysis going forward.
I will now turn it back to Guy Goldberg for reviewing additional R&D programs that are not COVID related.
Guy Goldberg
Thanks Gilead. So, we'll start with RHB-204. RHB-204 is a novel combination therapy of three antibiotic drugs that are active against non-tuberculous mycobacteria infection or NTM disease. We're currently in a Phase 3 study as a first-line therapy. This is important and its value-driving study because NTM is a difficult to treat infection with no FDA approved first-line standard-of-cure treatment. In addition, this is an orphan disease with an estimated 110,000 pulmonary NTM patients in the United States.
RHB-204 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.
This slide shows the study design. We are testing RHB-204 as a potential first-line standalone oral therapy. The randomized placebo controlled Phase 3 study is planned to enroll 125 subjects. The key study endpoints of sputum culture conversion and patient reported critical outcomes will be evaluated but six with longer term follow up including the post treatment benefits of conversion.
An important recent change is that we added an interim sample size we estimate at approximately 50% enrollment. In addition to accelerate recruitment, we're planning to expand the study to additional territories outside the United States, including the U.K. and Japan.
I will now provide an updated RHB-104, our innovative treatment for Crohn's disease. As Dror mentioned, based on recent published research, potential progress in Mycobacterium avium paratuberculosis or MAP, diagnostic technology may enable us to advance the program towards a confirmatory study and Mathcad positive, moderate severe Crohn's patients subject, of course, to required regulatory input.
As a reminder about this program, there is growing evidence that intracellular mycobacteria play a crucial role in Crohn's disease. Investigators have specifically identified MAP as the putative cause of the disease. Testing this theory, we conducted a Phase 3 study in Crohn's disease that successfully met our primary and key secondary endpoints, including remission at 26 weeks, response of week 26, early remission at week 16, durability, maintenance and others. Overall, RHB-104 demonstrated meaningful, consistent, and statistically significant clinical activity.
In addition, the apparent benefit in patients with concomitant anti-TNF use indicates that RHB-104 should potentially be used effectively and safely as an adjunct treatment to other standard-of-care medications.
Since we completed the Phase 3 study, there has been a lot of work by us and others on a companion diagnostic to identify MAP infection. It is not an easy thing to do. However, we believe based on recent public research, that there may be progress and we will have an update for investors as soon as we can validate the method.
If there is a successful diagnostic, we envision conducting an additional confirmatory clinical study with entry criteria being mapped positive status at a primary endpoint, including because of healing. We will of course need FDA feedback however, we envision that such a steady could be relatively small, perhaps 100 to 150 patients.
Crohn's disease is a large multi-billion dollar market with a large unmet medical need due to the limited benefit of monoclonal antibody therapy and other immune-suppressive drugs and safety related issues to those treatments.
I will now turn it over to Rob to walk through our commercial progress.
Rob Jackson
Thank you, Guy and good morning. Over the next few minutes, I'm going to summarize the excellent progress we made during the third quarter in our sales, marketing, and market access activities, so that you can understand how we've developed our business and why we feel increasingly confident about the fourth quarter and 2022.
In the third quarter, RedHill achieved record quarterly prescription volume for Talicia despite the continuously challenging pandemic environment. Talicia prescription volume grew by 117% over Q3 2020 and by 15%, a five-point improvement over the second quarter growth rate of 10%
Simultaneously, we added growth of Movantik over second quarter of 2021. RedHill continues to maintain clear market leadership of the PAMORA class and we are confident in our ability to capitalize on an improving selling environment during the fourth quarter.
In the second quarter, RedHill grew Movantik volume by 5.6% over first quarter of 2021 and we added an additional 1% growth in third quarter. We achieve this by taking a disciplined approach to focusing on the pain segment.
In tandem, we're also executing marketing strategies that focus on growing the PAMORA market. This is a key objective of Movantik as the established market leader. We've invested heavily in digital marketing tactics to first raise opioid-induced constipation awareness with patients and prescribers and secondly, to educate these potential customers about how Movantik can help provide relief from the symptoms of OIC.
During the third quarter, we also achieve significant market access successes with key payers that we believe will yield further growth Movantik during the fourth quarter and 2022.
A key predictor of the health of the OIC market is the growth or decline in the rate of opioid prescribing. As you can see here, opioid prescribing continues to stabilize during 2021, a major improvement over the declining trend that began way back in 2012. There is a very strong correlation between opioid prescribing and Movantik volume and a stable opioid prescribing trend provides support for Movantik in the entire PAMORA class.
On this next slide, you can clearly see the two other things are happening. First, prescribing volume in the PAMORA class is stabilizing, similar to what we're seeing in the opioid class and this is a good sign for Movantik.
Second, we can see a shift in PAMORA prescribing trends with the class beginning to return to growth. This is a significant change for the PAMORA class and on a moving annual total basis, PAMORA prescribing volume bottomed out in June and has remained steady or improved slightly since then. Again, this is a very good sign for Movantik business and reflects our efforts and investments as the market leader to return the PAMORA class to growth.
In summary, Movantik continues to achieve new milestones. Over 2.5 million prescriptions have been dispensed since launch. Overall, Movantik has achieved about 90% coverage across all payers and new prescriptions and total writers both increased year-on-year during third quarter of 2021.
Simultaneously, Talicia continue to achieve new milestones as well and in third quarter, Talicia achieved its best ever performance in terms of prescription volume growth.
Talicia achieved a new high in commercial payer coverage and Talicia also achieved further improvements in customer access, which in turn enabled greater trial and usage of the brand. Given what we have seen so far this quarter, we expect that this trend will accelerate in the fourth quarter.
In the third quarter, Talicia achieved 15% growth and we are optimistic this growth will accelerate as recent payer wins take effect, new payer wins come to fruition and field execution continues to improve.
Any microbial 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 treatments. These growing realizations among the prescriber community are enabling Talicia to achieve record performance in third quarter for weekly, monthly, and quarterly volume. And in the fourth quarter, we'll continue to increase our focus on Talicia and inspect to further accelerate our growth heading into 2022.
On the payer front, our market access team has continued to improve our very competitive position with commercial payers. Additionally, Talicia was recently awarded a very significant contract by Medi-Cal, the California State Medicaid program. Effective January 1st, 2022, Talicia will be available to 14 million Medi-Cal beneficiaries as a preferred brand with no restrictions. When all managed Medicaid plans will follow the state contract drug list, we are confident this will accelerate Talicia uptake in what is the second largest individual state in the country for H. pylori infections and treatments. This is another clear sign that prescribers increasingly recognize first, the challenges of clarithromycin resistance that were clearly outlined by the American College of Gastroenterology's 2017 guidelines. And secondly, the pitfalls of continuing to persist with using clarithromycin-based therapy as a first line agent of choice.
I want to reiterate; this brand continues to achieve new milestones. Again, we had record weekly, monthly, and quarterly prescription volume. We expect that that's going to continue into next year and certainly in the fourth quarter, we had our highest levels of commercial and government coverage, and we recently had the unrestricted Medi-Cal when as well. And lastly, we achieved 117% prescription volume growth over third quarter of 2020 with Talicia.
We also continue to promote Aemcolo to consumers, PCPs, and gastroenterologist. The COVID-19 pandemic has obviously had a very negative impact on international travel, especially non-essential travel outside of continental United States, where travelers' diarrhea risk is greatest. Our midterm expectations for Aemcolo are tempered by this reality.
In summary, we finished the third quarter with a consistent in growing trend of Talicia growth. We achieved numerous commercial milestones for Talicia. And as the market leader in the PAMORA class, we demonstrated our ability to continue to grow new Movantik prescriptions, stabilized prescription volume in the PAMORA class, and further improve on our already strong Movantik payer coverage. We're looking forward to further improving our performance in the fourth quarter in 2022.
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. Good afternoon. I will provide a short financial summary of the quarter. Revenue is executing on a consistent growth and value creation strategy, enabling us to be near quarterly commercial non-GAAP EBITDA breakeven by the end of this year.
We have achieved another quarterly record of net revenues and gross profits, accompanied by a reduction in operating and net loss. Our cash balance of $51.5 million as of September 30th, 2021 has been supplemented by more than $20 million in equity financing during this month of November.
Net revenues were $21.6 million for the third quarter of 2021, a second consecutive quarter of record net revenues attributable to an increase in revenues from both Talicia and Movantik, as shown by Rob.
The record net revenues also contributed a quarterly record gross profit of $12.4 million, an increase of 14% from previous quarter, which represents 57% gross margin from net revenues compared with 51% in the previous quarter.
On the expenses side, we had substantially lower expenses in the third quarter during the second quarter, $29.8 million compared with $35.8 million, mainly attributable to the completion of our global COVID-19 Phase 2/3 study with opaganib.
Operating loss was approximately $17.4 million compared with $24.9 million in the previous quarter, a decrease of 30%, which was mainly attributable to increase in revenues, increase in gross profit, completion of our -- great majority of our COVID-19 programs, and reduction in share-based compensation expenses.
Net cash used in operating activities was approximately $19 million for the third quarter of 2021, similar to the second quarter of 2021. We've ended the quarter well-positioned for potential quarterly commercial non-GAAP EBITDA breakeven by the end of this year.
I will now turn it over to Dror for Q&A.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions]
And your first question comes from the line of Brandon Folkes from Cantor Fitzgerald. Your line is now open, you may asked your question.
Brandon Folkes
Hi, thanks for taking my questions and congratulations on all the progress in both the pipeline and the commercial front. Maybe just firstly on opaganib, I appreciate all the additional data there. Should we think about the EMA as being the most receptive here and potentially, I know you said we're going to expect feedback from them first, is that indicative of that opaganib is probably going to be in the lead in the EMA versus the U.S.?
Maybe secondly, just staying on the pipeline on 204, you talked about expanding the territories in the Phase 3, is that just to speed up the pace of enrollments and the program or should we think of something else driving the potential expansion there?
And then lastly, if I may just slip in all three up front, on the Talicia coverage, obviously, congratulations, great coverage there. Just going forward, should we expect additional wins here or improvements in coverage? Or do you believe you're in a very strong steady state now and it's really just executing on those coverage points? Thank you.
Dror Ben-Asher
Thank you. Its Dror here. Starting with the question about EMA and whether this is likely to be the most important response in the short-term. So, you're right about saying that this is likely to be first responder as Gilead said before the end of the year. It's an expedited review, which we're very happy about, but it does not necessarily mean that this is the territory where we expect the fastest progress.
We are applying in many more countries, some of them with a very high degree an increasing need for treatment for this patient population in Latin America, in Europe, Israel, Switzerland, India, South Africa, and others and we do not know at this point which country or countries will be the most promising for an advance towards the market.
Your question about RHB-204 for NTM infections, yes, the speed of enrollment is the main reason that we are expanding the study to additional territories. The other reason is that we see strong need for RHB-204 for NTM infections in other countries, such as Japan, where there's actually more patients than in the U.S.
Your last question about Talicia coverage and whether we should be expecting additional coverage further improvement. Right now coverage is excellent, but it can be improved. I refer this to Bob Gilkin who is heading our Market Access team. Bob, would you like to elaborate on the Talicia coverage and what we can expect moving forward?
Bob Gilkin
Sure. Thank you, Dror. Appreciate that. So, first, Rob and I are committed with pulling through the great coverage that we have for Talicia, eight out of 10 commercially insured patients have access Talicia. Most of those patients have access with no restrictions.
We are committed to expanding that coverage. Our national account executive team is working hard diligently. We have of many things in the works right now. I cannot elaborate at this time, but definitely expect to see more wins as we go into 2022.
We're not done yet. If there's any indication of our ability to get it done, take a look at Movantik and what we were able to do once we acquired it from AstraZeneca. Our team is -- has continued to improve coverage and we expect to do the same thing with Talicia. Like I said that Rob and I are committed with pulling our current coverage through with our gritty at TCs out there in the field. Thank you.
Brandon Folkes
Great. Thank you very much. Appreciate all the detail.
Operator
Thank you. We will now be taking our next question that comes from the line of Ram Selvaraju from H.C. Wainwright. Your line is now open, you may ask your question.
Boobalan Pachaiyappan
This is Boobalan dialing in for Ram Selvaraju. Can you hear me okay?
Dror Ben-Asher
Yes, we can.
Boobalan Pachaiyappan
All right. Awesome, great. Great presentation, congrats on your progress. Just a few questions from our end. So, your Phase 2b post-hoc analysis looks solid and convincing. So, with respect to using FIO2 as a medical irrelevant parameter, so just curious, have you spoken to KOL and received any preliminary thoughts regarding its feasibility in current medical practice? Also, are there any limitations that you're aware of in using FIO2 as a relevant parameter in treating COVID patients?
Dror Ben-Asher
Thank you. Certainly we have interacted with KOLs and we will have further interaction as we indicated with regulators This is a change from what the standard World Health Organization Ordinal Scale characterizes a severity, but certainly FIO2 is a very well-known measure and parameter that is being used by the treating physicians and KOLs and we get feedback that is certainly a feasible parameter to utilize going forward, but we will have more inputs and further information once we have the regulatory feedback as be explained.
Boobalan Pachaiyappan
Okay, thanks for the clarity. So, with respect to the RHB-107 Phase 2/3 study, the data readout is expected in first quarter 2022. So, can you remind us whether you expect to report any preliminary efficacy data in addition to the safety?
Dror Ben-Asher
Sure. So, the RHB-107 study is two stage study. Part A is the part that we're currently completed enrollment for and expect topline readouts in Q1. This was a 60 patients part of the study, evaluating primarily the safety aspects of the two doses that we are evaluating and that will be the main outcome.
We will get, of course, and capture also efficacy endpoints and parameters, but given the relatively small size of the cohort, we don't expect to have clear indications on efficacy, but we may follow signals that we get and certainly, select a dose for optimal productivity going forward into the part B of the study, which will be the main part with efficacy.
Boobalan Pachaiyappan
Okay, thanks for the clarity. So, yes, with respect to RHB-107, are there any benefits limitations from a safety efficacy perspective in targeting serine proteases in COVID treatment? Also, are you aware of any competitors working in this space?
Dror Ben-Asher
So, in terms of the safety aspect, RHB-107 has been studied already even prior to COVID and other indications, extensively clinically, over 200 -- 400 I think patients altogether and the safety aspects are very well-established and adequate for treating the early stage patients -- outpatients of COVID-19. In fact, RHB-107 was provided on longer term basis in other indications. So, we're not concerned about safety aspects.
In terms of the second part of the question, can you remind me what else you asked?
Boobalan Pachaiyappan
Yes, just curious whether there are any -- are you aware of any competitors working in this space?
Dror Ben-Asher
In terms of the protease inhibitors, there are competitors that are targeting protease inhibitors or other compounds in a similar class. The serine proteases that our viral targeted, like the Pfizer drug are different class and different targets.
Boobalan Pachaiyappan
All right. Thanks for taking my questions. Congrats again.
Dror Ben-Asher
Thank you.
Operator
Thank you. We will now be taking our next question that comes from the line of David Hoang from SMBC. Your line is now open, you may ask your question.
David Hoang
Hey. Thank you for taking the questions. So, I had a few here. First one, just on, I guess, the scenario expectations for your discussions with regulators regarding the opaganib post-hoc analysis, you talked about running a confirmatory trial in using FIO2 to select patients. Is that -- I guess, is that definitely occurring? Or is that subject to regulatory feedback? Or any other factors in terms of your decision to pursue another trial?
Gilead Raday
Sure. Thank you, David. Certainly, everything that we have discussed is subject to the regulatory feedback that we will receive with -- according to the timelines that we illustrated of the expected feedback, initial feedback. Certainly, for further full approval processes, it's quite clear that additional study in the target population is likely to be required. The question will be that of timing, in terms of whether it is in parallel or prior to any other potential emergency uses in parallel to the study that we may contemplate.
And of course, the use of FIO2 is a selected parameter of the target population. Again, we think that it's very feasible and makes a lot of sense. But we will get regulatory feedback in that respect also.
David Hoang
Okay, got it. Thanks for that. And then on Talicia, I just had a question maybe you can helped me understand a little bit in terms of squaring the excellent script growth you're seeing in Talicia with the revenues reported for the quarter. So, can you just give a sense of maybe what type of rebating is going on for the product? And is there -- has there been any material change into gross to net for Talicia over recent quarters?
Dror Ben-Asher
Thank you, David. It's Dror here. Specific numbers for rebaiting is not something that any company would disclose. However, we can make general comments and I'll refer this to Bob.
Bob Gilkin
Yes, thank you Dror. Appreciate that. We are well within industry standards, probably doing a little bit better than industry standards as it relates to rebate contracting with our payer customers. We are -- we take a very conservative approach to discounting, we really watch our gross to net, we've been very fortunate with a product like Talicia, where the clinical attributes of the products are really the how it fares and does much better than the clarity base therapies really provides an advantage for us and payers do see the value in the product. So, we've been very fortunate on that front. But we've been able to maintain and hold on to that rebate line.
One of the challenges that we do see is that payers continue to increase rebates and more deductibles that we're seeing across the board. So, obviously, we're trying to kind of manage that and make sure that our products are affordable for our patients. Thank you.
David Hoang
Great, really appreciate you sharing that. And then just last question on RHB-104 and Crohn's disease. I guess do you provide any more color on the maybe expected timelines for further development there and your level of confidence in being able to secure the companion diagnostic tests?
Dror Ben-Asher
Thank you, David. Its Dror. I'm glad you asked because we are as committed as ever to RHB-104 for Crohn's disease. We have been asked by investors and numerous patients on a daily basis from all over the world what is happening with this program? How can we access this product for compassionate use? Numerous questions on a daily basis.
And we do understand that this is a potential breakthrough in the treatment paradigm. And the Phase 3 results that the Guy mentioned briefly, are robust and very, very promising. We're aware of all that. But in the last three or four years, we were reluctant to move forward into a confirmatory Phase 3 study without making sure that we are right on target when it comes to the patient population.
And the right types of patient population directly related to our suggested mechanism of access is Mycobacterium avium paratuberculosis infected Crohn's patients, as opposed to all-comers. Even though we were very successful in all-comers.
And very recently, there was, for the first time a peer-reviewed publication that disclosed a very important progress in detecting MAP which we believe gives us a decent chance of running the study that we always dreamed of.
Now, to the timelines, we expect to have some kind of idea about validating the test within weeks and we are highly committed to this program. So, we intend to go to the regulators quickly with proposed design and take it from there.
I'll remind you that the Holy Grail in Crohn's treatment is mucosal healing imaging and the mucosal healing data, which is completely objective from our Phase 3 study is very, very promising. We've shown significance in mucosal healing, despite a relatively small number of patients. So, again, we are very excited about this program and we are fully committed to moving it forward as quickly as possible because the patients are waiting for it and now, it seems that at last, we have a way forward.
David Hoang
Okay, thanks for the additional color Dror really appreciate it. That's it for me.
Operator
Thank you. We will now be taking our next question that comes from the line of Bert Hazlett from BTIG. Your line is now open. you may ask your question.
Robert Hazlett
Yes, thank you. Congratulations on the progress, especially impressed with Talicia and the efforts you're making there. Do you have any anecdotal -- along those lines, do you have any anecdotal evidence or circumstances you can present with regard to field force engagement? How's the traction growing or not with regard to your sales effort? And is -- could you describe the market a little bit, is it improving the diagnosis of the condition actually improving itself? Thank you.
Dror Ben-Asher
Thank you very much, Bert. Wonderful questions. I'll refer them to Rob.
Rob Jackson
Thank you Dror. Great question. We're definitely seeing a lot of improvement in what's happening in the field. I mean our team is executing better, but we're also seeing a lot of growth week-after-week, not only in volume, but also in consistency. So, I would say the traction is definitely improving in the field for Talicia.
In terms of the diagnostic component, I think the conditions have certainly improved if you go back to the peak of COVID last year or earlier this year, a lot of prescribers were not performing breath testing, for obvious reasons, as well as endoscopic biopsies in the hospital that has changed significantly. So, the -- although COVID is still a bit of an issue for us out there, it's certainly better than it was at the beginning of the year.
Robert Hazlett
Okay, thank you for that. And then maybe you mentioned it, and maybe I missed it, my apologies. Is there any chance you could give us a breakdown of revenue may be in percentage terms of Movantik versus Talicia in the quarter? Thank you for that. And apologies if I've missed it.
Micha Ben-Chorin
Sure. Thank you, Bert, this is Micha. So, about a little over $19 million coming from Movantik and almost $2.25 million coming from Talicia.
Micha Ben-Chorin
Terrific. Looking forward to hearing of the growth of Talicia going forward. Thanks.
Operator
Thank you. We will now be taking our next question that comes from the line of Scott Henry from ROTH Capital. Your line is now open, you may ask your question.
Scott Henry
Thank you and good morning or afternoon, possibly over there. I have a couple questions on the commercial operations and I may be a little more critical, but that's only because I want to understand exactly what's going on there.
Sequentially, from 2Q to 3Q, revenues only went up about $100,000. So, I have to assume Movantik was down sequentially, is that the correct assumption? And is that seasonal or how should we be thinking about that?
Dror Ben-Asher
Thank you. Its Dror here. No, it's not related at all. Doctor referrals and scripts are very different things sometimes.
Scott Henry
Okay. But Dror as you can see revenue is going down--
Micha Ben-Chorin
But I can add there Scott that both revenues from Movantik and Talicia went up and we took a negative impact from Aemcolo. So, both Talicia and Movantik are up.
Scott Henry
Can you give me any idea of how large the negative impact on Aemcolo was?
Micha Ben-Chorin
It's not very big. It's towards the neighborhood of $100,000.
Scott Henry
Okay. And with regards to Aemcolo, what are your thoughts there? Is it burning a lot of cash marketing the product, it means there's virtually no revenues coming from it, but I don't know -- which is understandable given COVID, but what -- is it taking a lot of resources is the question and how long can you keep doing that?
Dror Ben-Asher
Thank you Thank you, Scott about. I'll let Rob answer. Obviously, before I turn to Rob, the pandemic has had a very negative impact on travel to high risk territories. Therefore, what we have said in the beginning right before the pandemic with Aemcolo, which was very nice trend has come to a halt -- complete halt. I'll let Rob explain what we are doing right now in terms of our own investment, we're big believers in the product as the pandemic gradually hopefully eases. Rob?
Rob Jackson
Thank you, Dror. To answer the question relative to Movantik and Talicia, Aemcolo is taking very few resources right now. It's typically in a second or third position detail when the opportunity arises. So, I would not be concerned looking at this from the outside that we're overweighting our effort or our spend on Aemcolo relative to what we're able to deliver right now during the pandemic.
Scott Henry
Okay, I guess Rob and this is a question for you, because I know you sound very enthusiastic about the direction of the commercial division. But when I look at it, I mean, yes, the loss went way down in Q3 from Q2. But that's largely because it went way up from Q1 to Q2. So, I mean, if I compare Q3 to Q1, the story isn't as attractive.
So, my question is, when are we going to see an inflection point and really start to get that loss in a declining mode versus up one quarter, down one quarter? When can we see a sustainable improvement? Thank you.
Dror Ben-Asher
Rob, would you like to take this?
Rob Jackson
Sure. Certainly, in terms of Talicia, we are seeing a sustainable improvement. If you look at the slide in our deck for Talicia, we break out the prescription volume by month, you will see that there has been a sustainable improvement since the end of second quarter.
We have put more focus on Talicia second half of the year and we're definitely seeing an uptake and I know, based on what I'm seeing already, I'm very confident we're going to have a strong fourth quarter as well. So, we're heading in the right direction. And if you take that and combine that with the Medi-Cal win we have, it's going to kick into effect in January of next year.
I think between the sustained performance we're seeing in our core business plus what we'll get for Medicaid plus potentially some spillover there on the commercial side, I expect we'll be able to continue that trend right through 2022 and continue to accelerate.
Scott Henry
Okay. Just looking forward to seeing that commercial breakeven. And when I speak of the trends, obviously, I see the Talicia scripts every week, they look great, but just want to see that loss start to decline, because it is still a significant number. But shifting gears, I did want to ask the gross margin in the quarter looked pretty good. How should we think about that going forward?
Micha Ben-Chorin
So, you're right that we have a substantial increase this quarter and this is compared to previous two quarters in which we had the smaller margin mainly due to the shorter exploration of Talicia which comprise the part of the of the inventory and the channel.
And now after we got the FDA extension of the expiration from two years to three years, this is -- allows us to much better flexibility in the operations and also contribute to the increase margin. So, we will see an increase of margin going forward is compared with Q1 that you mentioned for example.
Scott Henry
So, I guess, what I'm saying is do you think Q3 gross margin, can you maintain that level going forward from Q3 number?
Micha Ben-Chorin
Q4 may be a little lower than Q3, but above Q1 and Q2 gross margins.
Scott Henry
Okay, that's helpful. Thank you. And then your final question -- I think it'll be the final. On opaganib, if you do have to do a confirmatory trial, how long do you think that would take from start to finish?
Gilead Raday
Thanks Scott. Gilead here. We think the last study that enrolled 450 -- over 450 patients actually was completed in a year -- close to a year. We think that given the positive data from the study targeted to the right population of the moderately severe hospitalized patients, we can probably do better than that. And given resources and potential support from external sources also, these public platforms or other sources, we could go even broader in terms of the number of sites and get the study done in under a year. So, that would be our target.
Scott Henry
Okay, great. Thank you for that color. And thank you for taking the questions.
Dror Ben-Asher
Thank you.
Operator
Thank you. So, no further question came through. Sir, please continue.
Dror Ben-Asher
Thank you, Brian. Thank you all for joining the call. Please feel free to reach out to us if you have any additional questions. Keep safe and have a pleasant day.
Operator
Thank you. That does conclude the conference for today. Thank you all for participating. You may all disconnect.
RedHill Biopharma Ltd. 2021 Q3 - Results - Earnings Call Presentation
Nov. 30, 2021 11:38 AM ETRedHill Biopharma Ltd. (RDHL), REDIF
The following slide deck was published by RedHill Biopharma Ltd. in conjunction with their 2021 Q3 earnings call.
https://seekingalpha.com/article/4472541-redhill-biopharma-ltd-2021-q3-results-earnings-call-presentation?utm_campaign=RTA+Articles&utm_medium=email&utm_source=seeking_alpha&utm_term=RTA+Article+Smart
RedHill Biopharma Reports Operational Highlights and Third Quarter 2021 Financial Results
https://finance.yahoo.com/news/redhill-biopharma-reports-operational-highlights-120000667.html
RedHill Accelerates its Two Advanced COVID-19 Pill Clinical Programs in Light of their Potential Against Omicron
Acting independently of spike protein mutation, opaganib and RHB-107's unique host-targeted mechanisms of action hold potential versus Omicron and other variants
-- Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality in moderately severe hospitalized patients; Data packages submitted in the U.S., EU (EMA has provided expedited evaluation process timelines), UK and other territories, ahead of regulatory advice
-- Top-line data from Part A of the COVID-19 Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients in the U.S. and South Africa expected in Q1/2022
-- Second consecutive quarter of record net revenues with $21.6 million for Q3/2021 and an increase in gross margin and steep reduction in operating and net loss; Cash balance[1] of $51.5 million as of September 30, 2021
-- Strategic investment in RedHill by South Korea's Kukbo Co. of up to $10 million as well as a $15.5 million underwritten public offering in November
-- Another record quarter for Talicia® revenues, with new prescription volume up 15%, reflecting 117% growth vs. Q3/2020; Movantik® continues to rise with an increase in quarterly new prescriptions of 1.1%
-- Continued prescription volume growth seen into the fourth quarter to date for both Talicia and Movantik, with coverage increase on both commercial and government formularies
-- Management to host webcast today, at 8:30 a.m. EST
TEL AVIV, Israel and RALEIGH, N.C., Nov. 30, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the third quarter ended September 30, 2021.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million despite the continuously challenging pandemic environment. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. In addition, gross margin increased from 51% in the second quarter to 57% in the third quarter. The Company has successfully attracted a strategic investment from South Korea's Kukbo and continues to demonstrate responsible financial discipline across the entire business as we strive to achieve our long-term growth aims."
Mr. Ben-Asher added: "Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107's host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19. This quarter saw significant focus on our opaganib Phase 2/3 COVID-19 study. The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience. Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries."
"In parallel, we continue to progress our Phase 2/3 study in the U.S. and South Africa with our other novel, once-daily, oral COVID-19 antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with top-line results expected in the first quarter of 2022. Our Phase 3 study of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to enroll patients in the U.S. and progress with Phase 3-stage RHB-104 for Crohn's disease is expected to speed up thanks to recent, much-awaited, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection research[2]."
"With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe RedHill is well positioned for short, medium and long-term success."
Financial highlights for the quarter ended September 30, 2021[3]
Net Revenues were $21.6 million for the third quarter of 2021, as compared with $21.5 million for the second quarter of 2021. The increase is attributable to an increase in sales of Talicia and Movantik, partially offset by an increase in gross-to-net deductions, mainly commercial rebates and Medicare discounts.
Gross Profit was $12.4 million for the third quarter of 2021, compared to $10.9 million for the second quarter of 2021 - an increase of 14%. Gross margin increased from 51% in the second quarter of 2021 to 57% in the third quarter of 2021. The increase in gross profit was mainly attributable to a reversal of inventory write-off recognized in the third quarter of 2021 following the FDA approval of an extension to Talicia stock expiration date.
Research and Development Expenses were $5.8 million for the third quarter of 2021, a decrease of $4.5 million, a 44% reduction compared to the second quarter of 2021, mainly attributable to the completion of our global COVID-19 Phase 2/3 study with opaganib.
Selling, Marketing and General and Administrative Expenses were $24 million for the third quarter of 2021, a decrease of $1.5 million compared to the second quarter of 2021. The decrease was mainly attributable to expenses related to share-based compensation in the previous quarter.
Operating Loss and Net Loss were $17.4 million and $21.4 million, respectively, for the third quarter of 2021 compared to $24.9 million and $29.1 million, respectively, in the second quarter of 2021. The decrease was mainly attributable to the Talicia inventory expiration date extension, completion of our opaganib Phase 2/3 COVID-19 study and a decrease in expenses related to share-based compensation, as detailed above.
Net Cash Used in Operating Activities was $19 million for the third quarter of 2021, similar to the second quarter of 2021.
Net Cash Used in Financing Activities was $1 million for the third quarter of 2021, comprised primarily of payables with respect to the Movantik acquisition, partially offset by proceeds from utilization of ATM and from exercise of options.
Cash Balance1 as of September 30, 2021, was $51.5 million.
Additional Financial Highlights
In November 2021, the Company announced that it had entered into a strategic agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of RedHill's American Depositary Shares (ADSs) in a private placement of up to $10 million, of which the first tranche of $5 million has been paid. As part of the agreement, the Company granted Kukbo a six month right of first offer for a license with respect to one or more of opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories.
In addition, this month, the Company completed an underwritten public offering of approximately 4.7 million ADSs for gross proceeds of approximately $15.5 million, led by Cantor Fitzgerald.
Commercial Highlights
Movantik® (naloxegol)[4]
The Company's focus on driving Movantik performance and strengthening of market share continues unabated, resulting in another quarter of new prescription growth, increasing by 1.1% compared to the previous quarter.
The Company has achieved significant market access successes with U.S. major payors, continuing to increase the levels of payor coverage.
In July, 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 September 2021 RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP and Nektar Therapeutics entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. resolving their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug Application (ANDA) seeking approval by the FDA to market a generic version of Movantik. This follows the previously announced resolution of the Apotex litigation and brings to a close all presently pending Movantik patent litigation brought pursuant to The Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act). The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030.
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[5]
Talicia achieved another record quarter, delivering a 15% increase in new prescriptions, compared to the previous quarter, reflecting 117% growth of Talicia as compared to Q3/2020.
In October, Medi-Cal - California's Medicaid Health Care program covering two million beneficiaries - had added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required. This coverage is expected to expand to 14 million beneficiaries on January 1, 2022. During the same month, a new U.S. Patent covering Talicia was granted. This patent reinforces the protection for Talicia through 2034, and the Company has listed this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
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 expanded access to Talicia to 26 million additional Americans and increased overall patient access to Talicia to greater than 8 out of 10 covered U.S. Commercial lives.
Aemcolo® (rifamycin)[6]
The Company has maintained promotion of Aemcolo in the third quarter of 2021 supporting the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. RedHill and Cosmo Pharmaceuticals N.V are currently in discussions with respect to the amendment of the Aemcolo License Agreement.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)[7]
In September 2021, the Company announced top-line results from the global 475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). Whilst results showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.
A post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (54% of the study participants), was subsequently reported in October 2021, demonstrating that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge, in this large group of hospitalized, moderately severe COVID-19 patients.
The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.
Additional new preclinical results demonstrating opaganib's efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis mode were also reported by the Company in September 2021.
The Company has submitted data packages for opaganib to the regulatory agencies in the U.S., EU, UK and other territories, ahead of planned regulatory advice, with the European Medicines Agency (EMA) having provided expedited evaluation process timelines. As previously stated, 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 previously indicated that 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.
The Company also continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the ongoing development of opaganib. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various territories.
COVID-19 Program: RHB-107 (upamostat)[8]
RedHill continues to advance the Phase 2/3 study of novel, once-daily, orally-administered, antiviral drug candidate, RHB-107, in the treatment of non-hospitalized patients with symptomatic COVID-19 in the early course of the disease who do not require supplemental oxygen - the vast majority of COVID-19 patients. The study plans to test for the Omicron variant.
Further to announcing in September 2021 that South Africa had joined the U.S. in approving the Phase 2/3 study, along with the expansion to additional U.S. sites, the Company announced this month that the last patient had been enrolled in Part A of the Phase 2/3 study. The study is a 2-part trial designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and based on safety and tolerability results of part A, a dose for part B will be selected. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.
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 is also assessing potential expansion of the RHB-204 Phase 3 study to additional territories.
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.
RHB-104 - Crohn's Disease
Based on recent published research, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) diagnostic technology may enable us to advance the program towards a confirmatory study in approximately 150 MAP positive moderate-severe Crohn's patients, subject to required regulatory input.
Opaganib - Prostate Cancer and Cholangiocarcinoma
In August 2021, we announced that, based on a preliminary review of partial and unaudited data, the ongoing Phase 2 study for prostate cancer had met its primary endpoint of at least six subjects demonstrating disease control (defined as stable disease or better after 16 weeks on treatment) among at least 27 evaluable subjects. Upon further review and analysis of the unaudited data, the Company reported that the study did not meet its primary endpoint in the study arm evaluating opaganib in combination with enzalutamide. Patient enrolment continues for the study's other arm, evaluating a combination of opaganib and abiraterone. Accrual and data entry are ongoing and results for the study remain subject to further review and analysis.
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, Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third 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: 9753927.
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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)
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http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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