RedHill Biopharma

RedHill Biopharma Ltd. develops medicines for gastrointestinal and infectious diseases. It operates through Commercial Operations, and the Research and Development segments. The Commercial Operations segment covers all areas relating to the commercial sales and is being performed by the subsidiary in the U.S. The Research and Development segment includes the study and licensing of therapeutic candidates. Its products include Talicia, Movantik, and Aemcolo. The company was founded by Dror Ben-Asher and Ori Shilo on August 3, 2009 and is headquartered in Tel Aviv, Israel.

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Non-binding agreement in principle reached with HCR on sale of Movantik to extinguish all debt obligations, to facilitate growth Q3/22 Net revenues of $17.6 million; Operating loss of $7.1 million; Q3/22 positive cash flow from U.S. commercial operations, before interest payments [1] ; Cash balance [2] of $31.4 million as of September 30, 2022 Talicia® and Movantik® have delivered year-to-date prescription growth of 65% and 6.7%, respectively; Q4/22 data to date indicate continued growth for both products Discussions underway regarding opaganib for nuclear radiation injury with various government agencies with expedited Animal Rule pathway expected, and potential eligibility for a medical countermeasures Priority Review Voucher; Development activities ongoing with opaganib for COVID-19 and other viral diseases for government pandemic preparedness purposes Advanced discussions ongoing regarding inclusion of once-daily oral RHB-107 in a U.S. platform trial for COVID-19 outpatients RHB-204 granted EU orphan drug designation providing 10 years of post-approval EU market exclusivity TEL AVIV, Israel and RALEIGH, N.C. , Nov. 29, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Announces Q3/22 Results and Operational Highlights

Positive in vivo results from a new study of opaganib in radiation-induced hematologic and renal toxicity reaffirms opaganib's potential protective impact on hematological and kidney function following total body irradiation (TBI) These new preclinical results are consistent with recently published, U.S. government funded, in vivo efficacy data suggestive of opaganib's potential as a nuclear radiation injury therapeutic for homeland security medical countermeasures (MCM) Opaganib is an oral, highly stable, novel small molecule pill potentially suitable, if approved, for central stockpiling by governments against mass casualty nuclear radiation incidents Following prior FDA guidance specific to opaganib, and subject to further FDA guidance, development of opaganib as a homeland security nuclear medical countermeasure is expected to follow the Animal Rule under which human efficacy studies may not be required Opaganib, if approved, may be eligible for a medical countermeasure Priority Review Voucher Discussions regarding further support and pathway to potential approval have been initiated with U.S. and other governments Development continues for COVID-19, other pandemic preparedness antiviral indications and oncology, strongly positioning opaganib as a pipeline-in-a-product TEL AVIV, Israel and RALEIGH, NC , Nov. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive in vivo results from a new pre-clinical study evaluating the effects of opaganib[1] on radiation-induced hematologic and renal toxicity, undertaken by RedHill and its partner Apogee Biotechnology Corporation ("Apogee").

RedHill Biopharma Announces Positive New Data with Opaganib for Nuclear Radiation Injury

Strong preclinical data, recently published in the International Journal of Molecular Sciences, from eight U.S government-funded in-vivo opaganib studies, supports opaganib's potential as a nuclear radiation injury therapeutic for homeland security material threat medical countermeasures (MCM) and for antitumor radiotherapy As an oral, small molecule pill that is highly stable with a more than five-year shelf-life, opaganib is easy to administer and distribute, supporting, if approved, potential central stockpiling by governments for possible use in mass casualty nuclear radiation incidents Unlike current approved options such as iodine pills, opaganib's suggested protective effect in radiation injury is not thought to be limited to specific radioactive materials or individual parts of the body. Rather, opaganib's mechanism of action is believed to suppress ionizing radiation toxicity and inflammatory damage to normal tissue, and promote the robustness of hematopoietic stem cells from radiation damage, potentially supporting increased survival and decreased morbidity Observations from multiple GI-focused in-vivo models indicate that opaganib may protect normal tissue from damage due to ionizing radiation exposure or cancer radiotherapy , improve antitumor activity and response to chemoradiation and enhance tolerability and survival Independent external in-vivo studies of the radioprotective capacity of opaganib in bone marrow also show enhanced survival against both lethal and half-lethal whole-body irradiation Another study has been initiated recently, by RedHill and its partner Apogee Biotechnology Corporation, to assess protective effects of opaganib against radiation-induced hematologic and renal toxicity Based on FDA guidance specific to opaganib, and subject to a recently scheduled follow-on meeting with FDA, RedHill expects development of opaganib as a homeland security nuclear medical countermeasure to follow the Animal Rule, under which pivotal animal model efficacy studies are applicable when human clinical trials are not ethical or feasible ; Discussions regarding further support, funding and development pathway to approval have been initiated with US and other governments Sponsors of approved medical countermeasures product applications are eligible for a medical countermeasure Priority Review Voucher Opaganib's development continues for COVID-19, other pandemic preparedness antiviral indications and oncology, strongly positioning opaganib as a major pipeline-in-a-product intended for multiple indications TEL AVIV, Israel and RALEIGH, NC , Nov. 14, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Accelerates Opaganib's Nuclear Radiation Protection Program - Positive Data Published

TEL AVIV, Israel and RALEIGH, N.C. , Nov. 14, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma Reaches Agreement in Principle with HCR to Extinguish All Debt Obligations in Exchange for Movantik®

Financial update : Q2/22: Net revenues of $18.3 million; Operating loss of $9.2 million; Cash balance [1] of $43.2 million as of June 30, 2022; Restated Q1/22: Net revenues of $13.1 million; Q3/22: Net revenues estimated [2] to be between $16.5million to $18.5 million; Operating loss estimated to be in the range of $5.5 million to $7.5 million; Q3/22 cash flow from operating activities is estimated positive for U.S operations, before interest payments [3] Commercial update : Upward trajectory continues with Talicia® and Movantik® new prescriptions up 11.2% and 4.0% over Q1/22, respectively; Commercial PBM win for Talicia improves coverage for 58 million more lives – Talicia on track to become the most prescribed branded H. pylori therapy in 2023; Market leader, Movantik, also anticipated to benefit from PAMORA class growth trends; With strong increases in gross sales, primary focus on improving gross-to-net yields Corporate update : Substantial impact from cost-reduction program expected in 2H/22, supporting planned improvement in cash from operations; Discussions advancing with HCR regarding default status and repayment of loan; Movantik sale process advancing rapidly aimed at satisfying outstanding obligations under the HCR credit agreement; Multiple RHB-204 out-licensing discussions progressing; Addition of significant revenue-generating GI products ongoing; Litigation against Kukbo initiated without counter-arguments from Kukbo and a favorable judgement is expected within weeks, strengthening the balance sheet significantly if collected R&D update : Opaganib and RHB-107 COVID-19 programs advancing; RHB-107 development funding and potential inclusion in a key platform trial, as well as other external non-dilutive financing, well advanced.

RedHill Biopharma Provides H1/22 Highlights and Q3/22 Estimates

Talicia's efficacy, in this analysis of pooled data from two Phase 3 studies, was unaffected by presence of diabetes or elevated body mass index (BMI); additionally, pharmacokinetic modeling results indicate that intragastric rifabutin exposure was unaffected by elevated patient BMI Published data suggest that elevated BMI and presence of diabetes may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations Talicia, the leading prescribed branded H.

RedHill Presents New Talicia® Data Analyses at Obesity Week 2022

Physiologically-Based Pharmacokinetic (PBPK) modeling study of Talicia evaluated intragastric antibiotic exposure, critical for successful H. pylori eradication, comparing low-dose rifabutin 50 mg every 8 hours to generic rifabutin triple therapy 150mg twice a day or 300 mg once a day.

RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022

RedHill Biopharma (RDHL) receives a new patent from the United States Patent and Trademark Office for its investigational COVID-19 candidate, opaganib, in COVID-19 patients with pneumonia. Stock up.

RedHill Biopharma (RDHL) Up on New Patent for COVID-19 Candidate

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Redhill Biopharma (NASDAQ: RDHL ) stock is rocketing higher on Wednesday after the company received a patent for one of its oral antiviral treatments. That patent covers the administration of opaganib.

What Is Going on With Redhill Biopharma (RDHL) Stock Today?

USPTO grants new method of use patent for the inhibition of a disease caused by a coronavirus in patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60% Previous variant-agnostic efficacy data for opaganib, an investigational new drug for COVID-19 disease and several other viral diseases, highlights its promising profile as a broad acting, host-directed candidate therapy for pandemic preparedness Development of opaganib for moderately severe COVID-19 patients is ongoing, including ongoing and planned pandemic preparedness research collaborations with US governmental agencies, pivotal Phase 3 trial design and regulatory clearances, and securing of external non-dilutive funding TEL AVIV, Israel and RALEIGH, N.C. , Oct. 19, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill's Oral Broad-Acting Antiviral, Opaganib, Granted New COVID-19 Treatment Patent

Novel, oral, host-targeted, broad-acting antivirals, once-daily RHB-107 (upamostat) and twice-daily opaganib, demonstrated in vitro inhibition of the COVID-19-causing SARS-Cov-2 Omicron BA.5 sub-variant in testing conducted by University of Tennessee Health Sciences Center Results add to previous variant-agnostic efficacy data for both investigational drugs against COVID-19 disease and several other viral diseases, highlighting their promising profile as broad acting, host-directed candidate therapies for pandemic preparedness Development of both opaganib for hospitalized patients and RHB-107 for non-hospitalized patients is ongoing, including ongoing and planned pandemic preparedness research collaborations with US governmental agencies, pivotal Phase 3 trial design and regulatory clearances, and securing of external non-dilutive funding TEL AVIV, Israel and RALEIGH, N.C. , Oct. 3, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill's Oral Broad-Acting Antivirals, Opaganib and RHB-107, Inhibit Dominant Omicron Sub-Variant BA.5

RedHill's (RDHL) RHB-204 gets Orphan Drug designation from the European Commission for the treatment of nontuberculous mycobacteria (NTM) disease

RedHill (RDHL) Up on Orphan Drug Tag for NTM Disease Drug

Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S. EMA Orphan Drug Designation provides eligibility for 10 years post-approval EU market exclusivity. U.S. FDA Fast Track, Orphan and QIDP priority designations, previously granted to RHB-204, extend U.S. post-approval market exclusivity to a total of 12 years The Company is advancing discussions with prospective partners for RHB-204 across multiple territories TEL AVIV, Israel and RALEIGH, N.C.

RedHill Biopharma Announces EU Orphan Drug Designation for RHB-204 for NTM Infections

Talicia® - World Gastro 2022 congress (August 17-18) : RedHill invited to give prestigious oral presentation of important data detailing high eradication rates across body mass index (BMI) groups with Talicia, the U.S.'s leading brand for Helicobacter pylori (H. pylori) eradication treatment - invitation sent to researchers with significant recently published clinical findings -- Opaganib for COVID-19 – Suggested host-directed mechanism of action described in Drug Design, Development and Therapy journal: Multi-faceted potential to: Inhibit spike protein-ACE2 binding, Akt signaling and endocytosis, induce autophagy and apoptosis, and disrupt the viral replication-transcription complex (RTC) through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS) - supports hypothesis of broad antiviral effect and attenuation of multi-organ dysfunction in COVID-19 patients   -- Opaganib for COVID-19 - 2nd ARDS Drug Development Summit (July 13-15) : Presenting new COVID-19 biomarker methodology utilizing baseline Fraction of Inspired Oxygen (FiO2) as a new disease severity classification paradigm - Phase 2/3 data demonstrating a 62% reduction in mortality in opaganib-treated patients requiring FiO2 up to 60% to be presented -- Opaganib and RHB-107 (upamostat) for COVID-19 - International Conference on Emerging Infectious Diseases (ICEID, August 7-10) : Presenting promising efficacy and safety data for RedHill's novel, oral, variant-agnostic investigational COVID-19 therapies, at ICEID, the premier infectious disease conference hosted by the CDC and the Global Task Force for Health   RALEIGH, N.C.

RedHill Announces New H. pylori and COVID-19 Data Publication and Presentations at Leading Upcoming Scientific Conferences

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RedHill Biopharma Ltd. (NASDAQ:RDHL ) Q1 2022 Results Conference Call June 23, 2022 8:30 AM ET Company Participants Debbie Bechor - Business Development & Communications Manager Dror Ben-Asher - Chief Executive Officer Rick Scruggs - President and Chief Commercial Officer Guy Goldberg - Chief Business Officer Gilead Raday - Chief Operating Officer Micha Ben-Chorin - Chief Financial Officer Adi Frish - Chief Corporate and Business Development Officer Rob Jackson - Senior Vice President of Marketing Conference Call Participants Brandon Folkes - Cantor Fitzgerald Boobalan Pachaiyappan - H.C.

RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q1 2022 Results - Earnings Call Transcript

RedHill Biopharma Ltd (NASDAQ: RDHL) plans announced a cost reduction plan expected to generate operational cost savings of approximately $50 million over the next 18 months. Most of these savings result from an approximately one-third reduction of the U.S. commercial team workforce,.

RedHill Biopharma Shares Trading Higher On Improved Q1 Profitability

Targeting positive cash from operations to start during H2/22 [1] Focus on earlier achievement of operational profitability thanks to a recently implemented comprehensive cost reduction plan, with expected operational cost savings of approximately $50 million over the next 18 months Continuous implementation of disciplined cost controls reduced Q1/22 cash used in operating activities by more than 70% to approximately $4 million, compared to approximately $15 million in Q4/21 Net revenues of $18.2 million in Q1/22; Cash balance [2] of $45 million as of March 31, 2022 Talicia® TRx up 12.8% over Q4/21 and Movantik® continues strong Q4/21 prescription performance Amendment improves key covenants in the HCR Credit Agreement Given encouraging data to date, opaganib and RHB-107 COVID-19 Phase 3-stage programs expected to be funded via external sources; Global and U.S. regulatory interactions ongoing Management to host webcast today, at 08:30 a.m. EDT TEL AVIV, Israel and RALEIGH, N.C.

RedHill Biopharma Announces Q1/22 Highlights: On Track for Positive Cash from Operations in H2/22

TEL AVIV, Israel and RALEIGH, N.C. , June 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill Biopharma to Host First Quarter 2022 Financial Results and Operational Highlights Webcast on June 23, 2022

Talicia's efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H.

RedHill Presents New Talicia® Data Analyses at DDW 2022

TEL AVIV, Israel and RALEIGH, N.C , May 9, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement with a single leading healthcare investor for the purchase and sale of 10,563,380 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing ten (10) ordinary shares, at a purchase price of $1.42 per ADS (or ADS equivalent), in a registered direct offering.

RedHill Biopharma Announces $15 Million Registered Direct Offering with a Leading Healthcare Investor

Redhill Biopharma Ltd. (RDHL) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart.

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