RDHL Redhill Biopharma Ltd.

7.31
+0.6  (+9%)
Previous Close 6.71
Open 6.67
52 Week Low 5.3403
52 Week High 11.52
Market Cap $3,391,467,556
Shares 463,949,050
Float 463,949,050
Enterprise Value $380,114,859
Volume 318,258
Av. Daily Volume 622,213
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Opaganib
COVID-19
Phase 2/3
Phase 2/3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
RHB-107 (upamostat)
COVID-19 (outpatients)
Phase 2/3
Phase 2/3
Phase 2/3 initiation of dosing announced February 17, 2021.
Opaganib
COVID-19
Phase 2a
Phase 2a
Phase 2 initial data released December 31, 2020.
RHB-204
Nontuberculous mycobacteria (NTM) infections
Phase 3
Phase 3
Phase 3 trial initiation announced November 20, 2020.
Yeliva (Opaganib)
Cholangiocarcinoma
Phase 2a
Phase 2a
Phase 2a enrolment of second arm has been initiated - March 11, 2020.
RHB-104 MAP
Crohn’s disease
Phase 3
Phase 3
Phase 3 data released July 30, 2018. Primary endpoint met but further trial required.
BEKINDA
Gastroenteritis
Phase 3
Phase 3
Phase 3 additional trial planned.
Talicia RHB-105
H. pylori
Approved
Approved
FDA Approval announced November 4, 2019.
BEKINDA
IBS-D
Phase 2
Phase 2
Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05. Follow up analysis identfied p value = 0.036. Phase 3 trial planned.

Latest News

  1. TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to approximately 380 patients.

    RedHill Biopharma Logo

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With approximately…

    TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to approximately 380 patients.

    RedHill Biopharma Logo

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib." Dr. Levitt continued: "Moreover, adding together the positive Phase 2 data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase 2/3 study, which will provide the clearest indication to date of opaganib's promise in treating COVID-19."

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is over 75% enrolled in approximately 40 recruiting sites.

    RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.

    To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib 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. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication 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, and mitigate pulmonary fibrotic damage, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing 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.   

    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[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. 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 (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a 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 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements 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 the risk of a delay in top-line data from the Phase 2/3 COVID-19 study, that such a study may not be successful, that opaganib 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

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] 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.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharmas-phase-23-covid-19-study-of-opaganib-passes-fourth-dsmb-review-with-unanimous-recommendation-to-continue-301265728.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  2. TEL AVIV, Israel and RALEIGH, N.C., March 25, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

    RedHill Biopharma Logo

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe

    TEL AVIV, Israel and RALEIGH, N.C., March 25, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

    RedHill Biopharma Logo

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

    Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.

    The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to MSN. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with MSN does not end RedHill's ongoing litigation against the other two ANDA filers.

    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[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. 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 (Yeliva®), a first-in-class 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), a serine protease inhibitor in a U.S. Phase 2/3 study 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 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

     

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements 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, 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 risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) 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; (ix) 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; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) 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; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) 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 4, 2020. 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

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     



    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-announces-settlement-of-movantik-patent-litigation-with-msn-pharmaceuticals-301256045.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  3. TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has acted on a request to provide opaganib[1] treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from COVID-19 pneumonia.

    RedHill Biopharma Logo

    Acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered opaganib within the past week. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be…

    TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has acted on a request to provide opaganib[1] treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from COVID-19 pneumonia.

    RedHill Biopharma Logo

    Acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered opaganib within the past week. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be effective against emerging viral variants with mutations in the spike protein.

    Gilead Raday, RedHill's Chief Operating Officer, said: "We continue to do all we can to support patients, and their treating physician, who are in need of treatment options for COVID-19. Having recently reported positive Phase 2 data with opaganib in the U.S., our ongoing global 464-patient Phase 2/3 study with opaganib for severe COVID-19 is now more than two thirds enrolled."

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is advancing in a total of eight countries and approximately 40 recruiting sites.

    RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.

    To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib 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. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Preclinical data have demonstrated anti-inflammatory, antiviral and anti-thrombotic activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome.

    Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing 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.   

    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[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. 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 (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a 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 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements 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 the risk that opaganib 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

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] 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.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-announces-compassionate-use-treatment-with-opaganib-of-first-covid-19-patients-in-switzerland-301252751.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  4. New York, March 18, 2021 (GLOBE NEWSWIRE) -- - Altiplano Metals closes C$3.1 million non-brokered private placement click here

    - Victory Square Technologies Inc (CSE:VST) (OTC:VSQTF) (FRA:6F6) says GameOn Entertainment Technologies has added veteran digital and media expert Liz Schimel to board click here

    - RedHill Biopharma Ltd (NASDAQ:RDHL) delivers revenue growth, commercial expansion and pipeline progress in FY2020 results as focused efforts pay off click here 

    - Goldcore Resources Ltd (CVE:GEM) (FRA:BK2P) to start trading as Green Battery Minerals on Monday, March 22 click here

    - ME2C Environmental  (OTCQB:MEEC) announces its participation in the creation of a new technologies firm, Eleclear Technologies click here 

    New York, March 18, 2021 (GLOBE NEWSWIRE) -- - Altiplano Metals closes C$3.1 million non-brokered private placement click here

    - Victory Square Technologies Inc (CSE:VST) (OTC:VSQTF) (FRA:6F6) says GameOn Entertainment Technologies has added veteran digital and media expert Liz Schimel to board click here

    - RedHill Biopharma Ltd (NASDAQ:RDHL) delivers revenue growth, commercial expansion and pipeline progress in FY2020 results as focused efforts pay off click here 

    - Goldcore Resources Ltd (CVE:GEM) (FRA:BK2P) to start trading as Green Battery Minerals on Monday, March 22 click here

    - ME2C Environmental  (OTCQB:MEEC) announces its participation in the creation of a new technologies firm, Eleclear Technologies click here 

    - Recruiter.com Group Inc (OTCQB:RCRT) boosts board with two new independent directors - an M&A and a human resources specialist click here 

    - Victory Resources  Corporation (CSE:VR) (OTC:VRCFF) (FRA:VR62) acquires the Smokey Lithium Project in Nevada click here 

    - Alpine 4 Holdings Inc (OTCQB:ALPP) taps former US Air Force Technical Sargent Nathan Grier for its Vayu unmanned aerial systems subsidiary click here 

    - Orgenesis Inc (NASDAQ:ORGS) collaborates with MIDA Biotech to establish point-of-care centers at hospitals and other medical institutions across western Europe click here 

    - Trillion Energy International Inc (CSE:TCF) (OTC:TCFF) (FRA:3P2N), the Turkey and Bulgaria-focused oiler, reveals latest year-end reserves report click here 

    -  American Resources Corporation (NASDAQ:AREC) says sponsored $100 million American Acquisition Opportunity SPAC begins trading on NASDAQ click here 

    - Blackrock Silver Corp (CVE:BRC) hits high-grade silver and gold at its Tonopah West project in Nevada click here 

    -  HempFusion Wellness Inc (TSE:CBD.U) (OTC:CBDHF) (FRA:8OO) to enter massive China market via subsidiary Probulin Probiotics on Alibaba Group Holding's Tmall Global click here 

     - Safe-T Group Ltd (NASDAQ:SFET) (TASE:SFET) subsidiary launches new IP Proxy platform click here 

     - NEXE Innovations Inc (CVE:NEXE) (OTC:NEXNF) (FRA:NX5) set to fully launch its XOMA Superfoods product line after a stellar pilot debut click here 

     - Marble Financial Inc (CSE:MRBL) (OTC:MRBLF) (FRA:2V0) launches its AI-driven financial wellness platform MyMarble with Canada Finances click here 

     - Silver Range Resources Ltd (CVE:SNG) (OTC:SLRRF) (FRA:8SR) updates on work progress at Stinson and Lucky Boy properties in Nevada click here 

     - First Mining Gold Corp (TSE:FF) (OTCQX:FFMGF) (FRA:FMG) says Auteco set to earn 51% of Pickle Crow gold project after fulfilling first stage requirements click here 

     - Aurania Resources Ltd (CVE:ARU) (FRA:20Q)  says undertaking overnight marketed public offering of units for gross proceeds of up to C$6.75M click here 

     - Vuzix Corp (NASDAQ:VUZI) (FRA:V7XN) M400 Smart Glasses deployed at New York distribution center click here 

     - Endeavour Mining Corp (TSE:EDV) (OTCQX:EDVMF) (FRA:E5Y1) reports record 4Q and FY2020 production from its West African gold operations click here 

     - PyroGenesis Canada Inc (TSX:PYR) (NASDAQ:PYR) (FRA:8PY) receives grant to develop pot lining waste recovery process click here 

     - NetCents Technology Inc (CSE:NC) (FRA:26N) (OTCQB:NTTCF) reports cryptocurrency transaction volume exceeds $10.8M in first half of March click here 

     - The Valens Company (TSE:VLNS) (OTCQX:VLNCF) (FRA:7LV) set to launch Verse Cannabis products on the Medical Cannabis by Shoppers platform click here 

     - XPhyto Therapeutics Corp (CSE:XPHY) (OTC:XPHYF) (FRA:4XT) announces EU approval for coronavirus test click here 

    - Heritage Cannabis Holdings Corp (CSE:CANN) (OTCQX:HERTF) says Health Canada has granted it the first-ever license to export cannabis products from Canada to Brazil click here 

    - Loop Insights Inc (CVE:MTRX) (OTCQB:RACMF) enters into five-store pilot with Canadian grocer Sobeys to deliver digital receipts via its Wallet Pass technology click here 

    - Delta 9 Cannabis Inc (TSX:DN) (OTCQX:DLTNF) announces grand opening of its eleventh cannabis retail store, and eighth in the Province of Manitoba click here 

    - Soma Gold Corp (CVE:SOMA) (OTC:PRSRF) (FRA:8PR1) encouraged by exploration drill results at its Colombia assets click here 

       

    About Proactive

    With six offices on three continents and a team of experienced business journalists and broadcasters, Proactive works with innovative growth companies quoted on the world's major stock exchanges, helping executives engage intelligently with investors.

    Proactive' s platform delivers the right message to the right audience, digitally and in real time, leveraging a range of media, investment research, digital investor targeting and website development services to support over 1,000 fast-growing companies globally.

    Proactive's network reaches over 12 million engaged private, professional and institutional investors looking for opportunities.

    •           Our written and video content is published on Proactive sites that collectively attract up to 10 million views per month.

    •           We syndicate our content to hundreds of mainstream and specialist news sites that expand our reach into networks that can be difficult for press releases to penetrate.

    •           We custom build corporate websites from the ground up, empowering clients and their brands with a modern online presence and the latest insight on effective SEO strategy.

    •           Our news coverage ranks high on the world's most popular search platforms, and we can further amplify online presence and outreach with sophisticated digital investor targeting.

    •           We help the world understand what makes companies stand out from the crowd with in-depth investment research from a team of experienced analysts.

    For more information on how Proactive can help you make a difference, email us at



    Primary Logo

    View Full Article Hide Full Article
  5. TEL AVIV, Israel and RALEIGH, N.C., March 18, 2021 /PRNewswire/ --

    Financials:

    Full year 2020 net revenues of approximately $64 million, with gross profit of approximately $27.5 million

    Solid cash balance of approximately $100 million as of March 4, 2021

    Planned commercial operational breakeven by the end of 2021

    Commercial Highlights:

    Talicia: Consistent month-over-month prescription growth despite pandemic conditions, with 52% new prescription growth in Q4/2020 compared to Q3/2020

    Movantik: Market leadership position holding strong and well-positioned for further growth in 2021

    R&D Highlights:

    Two advanced programs at the forefront of global COVID-19 novel therapeutics development:

      • Opaganib: Ongoing global Phase 2/3 study in hospitalized

    TEL AVIV, Israel and RALEIGH, N.C., March 18, 2021 /PRNewswire/ --

    Financials:

    Full year 2020 net revenues of approximately $64 million, with gross profit of approximately $27.5 million

    Solid cash balance of approximately $100 million as of March 4, 2021

    Planned commercial operational breakeven by the end of 2021

    Commercial Highlights:

    Talicia: Consistent month-over-month prescription growth despite pandemic conditions, with 52% new prescription growth in Q4/2020 compared to Q3/2020

    Movantik: Market leadership position holding strong and well-positioned for further growth in 2021

    R&D Highlights:

    Two advanced programs at the forefront of global COVID-19 novel therapeutics development:

      • Opaganib: Ongoing global Phase 2/3 study in hospitalized patients approximately two thirds enrolled, data expected Q2/2021; Positive U.S. Phase 2 data reported



      • RHB-107: Ongoing U.S. Phase 2/3 study in symptomatic non-hospitalized patients

    RHB-204: Ongoing Phase 3 study for pulmonary NTM disease as oral first-line treatment

    Management to host webcast today, at 8:30 a.m. EDT

    RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the year ended December 31, 2020.

    RedHill Biopharma Logo (PRNewsfoto/RedHill Biopharma)

    Dror Ben-Asher, RedHill's Chief Executive Officer, said: "2020 was a year that our team looks back on with a sense of immense achievement. While navigating the challenging conditions caused by the pandemic, we have delivered broad commercial growth culminating in a very strong end to 2020 for both Movantik and Talicia". Mr. Ben-Asher continued: "At the same time, we have rapidly progressed two novel oral COVID-19 therapies to Phase 3 stage development, covering both hospitalized and non-hospitalized patients and have reported positive clinical and preclinical data, positioning RedHill at the forefront of novel COVID-19 therapeutics development worldwide. With strong momentum across both commercial and R&D operations, we expect 2021 to be a breakout year."

    Micha Ben Chorin, Chief Financial Officer at RedHill, added: "RedHill is delivering on a clear strategy designed to enable us to achieve fast growth and increased profit margin. We have been diligent in maintaining a solid balance sheet and we expect to achieve commercial operational breakeven by the end of this year." 

    Financial highlights for the year ended December 31, 2020

    Net Revenues were approximately $64 million for the year ended December 31, 2020, an increase of $58 million compared to the year ended December 31, 2019, attributed to revenues generated from the commercialization of Movantik and Talicia initiated in 2020. Net revenues for the fourth quarter of 2020 were approximately $21.5 million, an increase of $0.5 million compared to the third quarter of 2020, with a 12% increase in product delivery.

    Gross Profit was approximately $27.5 million for the year ended December 31, 2020, an increase of $23.5 million compared to the year ended December 31, 2019, primarily due to the increase in net revenues.

    Research and Development Expenses were approximately $16.5 million for the year ended December 31, 2020, mainly attributable to the development of our COVID-19 therapeutics and the Phase 3 study of RHB-204 for pulmonary NTM disease, and were, in total, lower than the research and development expenses for the year ended December 31, 2019.

    Selling, Marketing and Business Development Expenses were approximately $49 million for the year ended December 31, 2020, compared to approximately $18 million for the year ended December 31, 2019. The increase was attributable to the expansion of our U.S. sales force and marketing activities, in support of the launch of Talicia and post-acquisition commercialization of Movantik.

    General and Administrative Expenses were approximately $25 million for the year ended December 31, 2020, compared to approximately $11 million for the year ended December 31, 2019. The increase was mainly attributable to the expansion of commercialization activities related to the Talicia launch and the Movantik acquisition from AstraZeneca.

    Operating Loss was approximately $64 million for the year ended December 31, 2020, compared to approximately $43 million for the year ended December 31, 2019. The increase was attributable to the expansion of our commercial operations.

    Net Loss was approximately $76 million for the year ended December 31, 2020, compared to approximately $42 million for the year ended December 31, 2019. The increase was attributable to factors mentioned above, as well as interest expenses mainly related to the royalty and debt financing in the first quarter of 2020. 

    Net Cash Used in Operating Activities was approximately $49 million for the year ended December 31, 2020, compared to approximately $41 million for the year ended December 31, 2019. The increase was attributable to the increase in operating loss, as described above.

    Net Cash Used in Investing Activities was approximately $36 million for the year ended December 31, 2020, primarily related to the $52.5 million upfront payment to AstraZeneca for the acquisition of Movantik, partially offset by inflow from current bank deposits and financial assets at fair value through profit or loss. 

    Net Cash Provided by Financing Activities was approximately $84 million for the year ended December 31, 2020, comprised primarily from financing inflow of approximately $102 million, mainly in debt and equity, partially offset by $16 million classified as restricted cash.

    Liquidity and Capital Resources

    Cash Balance[1] as of December 31, 2020, was approximately $46 million. Cash balance as of March 4, 2021 was approximately $100 million.

    Commercial Highlights

    Movantik® (naloxegol)[2]

    The Company has completed three full quarters of Movantik promotion following its acquisition from AstraZeneca, achieving: A reversal of the trend of declining new prescriptions prior to the acquisition, maintaining Movantik's position as a segment-leading brand and ending 2020 strongly recording the second highest monthly new prescription volume of 2020 in December.

    RedHill acquired the global rights to Movantik from AstraZeneca, excluding Europe and Canada, subsequently adding Israel rights, and replaced a co-commercialization agreement with Daiichi Sankyo (assigned under the agreement with AstraZeneca), with a new royalty-bearing agreement that resulted in RedHill assuming full control over brand strategy and commercialization activities for Movantik in the U.S. and increasing gross margin.

    Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[3]

    Despite the challenging pandemic environment, the Company has persisted in its efforts to support the launch and rapid growth of Talicia, in particular in expanding the prescriber base. This has resulted in the strong accumulation of new Talicia prescribers in the second half of 2020 and consistent month-over-month prescription growth despite pandemic conditions. Talicia ended 2020 strongly, with 52% new prescription growth in the fourth quarter of 2020, as compared to the previous quarter, and achieving its highest weekly new prescription volume in December.  

    This growth is supported by the addition of Talicia as a preferred brand on leading national formularies, approaching 70% U.S. commercial coverage in the fourth quarter, with further formulary additions expected to add to the previously announced listings of Talicia on the national formularies of Prime Therapeutics, EnvisionRx, and Express Scripts.

    Aemcolo® (rifamycin)[4]

    The Company has implemented plans to support, and build on, the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. The Company expects that these plans will drive a resurgence of interest in Aemcolo once travel restrictions are lifted and international travel from the U.S. returns to significant levels.

    R&D Highlights

    COVID-19 Program: Opaganib (ABC294640, Yeliva®)[5] 

    The late-stage development program for novel, orally-administered, opaganib in patients with severe COVID-19 pneumonia is progressing rapidly. Opaganib has demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be effective against emerging viral strains with mutations in the spike protein.

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is rapidly advancing in a total of 8 countries and approximately 40 recruiting sites, with additional expansion ongoing. The study has passed three Data Safety Monitoring Board reviews, including a futility review, which is suggestive that the study is progressing as expected. The 464-patient study has already enrolled approximately two thirds of the patients and is expected to deliver top-line data in the second quarter of 2021.

    In December 2020, the Company reported positive top-line safety and efficacy data from the U.S. Phase 2 study with opaganib in patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing opaganib safety database.

    In September 2020, RedHill announced that opaganib demonstrated potent inhibition of SARS-CoV-2, achieving complete blockage of viral replication, as measured after three days incubation, in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study. Furthermore, treatment of cells infected with SARS-CoV-2 with opaganib did not compromise cell membrane integrity, a measure of cell viability and drug safety, further demonstrating opaganib's promising potential for treating patients with COVID-19. On top of its anti-inflammatory mechanism, opaganib is also one of very few orally available broad-spectrum antivirals in advanced clinical evaluation for treating COVID-19.

    The Company also signed collaborations with several U.S., European and Canadian suppliers, including with Cosmo Pharmaceuticals NV (SIX: COPN) for large-scale ramp-up of opaganib manufacturing, further strengthening manufacturing capabilities and capacity for opaganib.

    The Company continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up.

    COVID-19 Program: RHB-107 (upamostat)[6]

    In February 2021, RedHill announced dosing of the first patient in the U.S. Phase 2/3 COVID-19 outpatient study with novel, orally-administered, RHB-107 (upamostat). The study with once-daily RHB-107 is evaluating treatment of patients with symptomatic COVID-19 who do not require hospitalization - the vast majority of COVID-19 patients. The study allows patients to remain in the comfort of their home yet be monitored at a level previously possible only in a hospital setting, enabling increased compliance and retention rates.

    RHB-107 is a novel, orally-administered, serine protease inhibitor targeting human cell factors involved in viral entry and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. In previously announced in vitro results, RHB-107 strongly inhibited SARS-CoV-2 viral replication.

    RHB-204[7] - Pulmonary Nontuberculous Mycobacteria (NTM) Disease      

    In November 2020, RedHill commenced its U.S. Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection.

    The FDA also granted Fast Track designation for RHB-204 in January 2021, providing early and frequent communications and a rolling review of any New Drug Application (NDA). Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

    In October 2020, the Company announced that RHB-204 had been granted FDA Orphan Drug Designation. This, along with the previously granted QIDP designation, extends U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.

    Opaganib - Cholangiocarcinoma and Prostate Cancer

    The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing. 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.

    In light of preclinical findings demonstrating tumor regression following combination treatment with opaganib and RHB-107 (upamostat), RedHill plans to add an additional cohort to the ongoing Phase 2a study, evaluating opaganib in combination with RHB-107, subject to discussions with the FDA. Opaganib has been granted FDA Orphan Drug Designation for the treatment of cholangiocarcinoma.

    An additional Phase 2 study with opaganib in prostate cancer is ongoing at the Medical University of South Carolina (MUSC). The study is supported by a National Cancer Institute grant awarded to MUSC with additional support from RedHill.

    COVID-19 Impact Update

    RedHill's primary concern during the COVID-19 pandemic continues to be the safety and health of its employees, patients, colleagues, and the communities to which we belong.

    Operationally, the actions the Company took to mitigate the impact of the COVID-19 pandemic continue to serve us well, with minimal effect on our ongoing operational and supply chain activities. Promotional activity has now been largely re-instated, where safe to do so, and in adherence to social distancing and other public health guidelines. RedHill will continue to assess the potential impact of COVID-19 on its business and operations.

    Conference Call and Webcast Information:

    The Company will host a conference call and live webcast today, Thursday, March 18, 2021, at 8:30 a.m. EDT to present the fourth quarter and full year 2020 financial results and operational highlights.

    The webcast and 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: 1830718.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class 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), a 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 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding planned commercial operational breakeven by the end of 2021 and regarding achieving fast growth and increased profit margin. 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate and Business Development

    Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  



     

    REDHILL BIOPHARMA LTD.

    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS































    Year Ended December 31, 











    2020



    2019



    2018











    U.S. dollars in thousands

    NET REVENUES









    64,359



    6,291



    8,360

    COST OF REVENUES









    36,892



    2,259



    2,837

    GROSS PROFIT









    27,467



    4,032



    5,523

    RESEARCH AND DEVELOPMENT EXPENSES









    16,491



    17,419



    24,862

    SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES









    49,285



    18,333



    12,486

    GENERAL AND ADMINISTRATIVE EXPENSES









    25,375



    11,481



    7,506

    OPERATING LOSS









    63,684



    43,201



    39,331

    FINANCIAL INCOME









    270



    1,335



    678

    FINANCIAL EXPENSES









    12,759



    438



    167

    FINANCIAL EXPENSES (INCOME), net









    12,489



    (897)



    (511)

    LOSS AND COMPREHENSIVE LOSS FOR THE YEAR









    76,173



    42,304



    38,820





















     

    REDHILL BIOPHARMA LTD.

    CONSOLIDATED STATEMENTS OF FINANCIAL POSITION













    December 31,



    2020



    2019



     U.S. dollars in thousands

    CURRENT ASSETS:







    Cash and cash equivalents

    29,295



    29,023

    Bank deposits

    17



    10,349

    Financial assets at fair value through profit or loss

    481



    8,500

    Trade receivables

    28,655



    1,216

    Prepaid expenses and other receivables

    5,521



    2,244

    Inventory

    6,526



    1,882



    70,495



    53,214

    NON-CURRENT ASSETS:







    Restricted cash

    16,164



    152

    Fixed assets

    511



    228

    Right-of-use assets

    5,192



    3,578

    Intangible assets

    87,879



    16,927



    109,746



    20,885

    TOTAL ASSETS

    180,241



    74,099

















    CURRENT LIABILITIES: 







    Accounts payable

    11,553



    4,184

    Lease liabilities

    1,710



    834

     Allowance for deductions from revenue

    18,343



    1,267

    Accrued expenses and other current liabilities

    24,082



    4,331

    Payable in respect of intangible assets purchase

    17,547





    73,235



    10,616









    NON-CURRENT LIABILITIES:







    Borrowing

    81,386



    Payable in respect of intangible assets purchase

    7,199



    Lease liabilities

    3,807



    2,981

    Royalty obligation

    750



    500



    93,142



    3,481

    TOTAL LIABILITIES

    166,377



    14,097









    EQUITY:







    Ordinary shares

    1,054



    962

    Additional paid-in capital

    293,144



    267,403

    Accumulated deficit

    (280,334)



    (208,363)

    TOTAL EQUITY

    13,864



    60,002

    TOTAL LIABILITIES AND EQUITY

    180,241



    74,099

     

    REDHILL BIOPHARMA LTD.

    CONSOLIDATED STATEMENTS OF CASH FLOWS





















    Year Ended December 31,





    2020



    2019



    2018





    U.S. dollars in thousands

    OPERATING ACTIVITIES:













    Comprehensive loss



    (76,173)



    (42,304)



    (38,820)

    Adjustments in respect of income and expenses not involving cash flow:













    Share-based compensation to employees and service providers



    4,202



    3,027



    2,678

    Depreciation



    1,710



    997



    90

    Amortization and impairment of intangible assets



    7,035



    216



    Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase and royalty obligation



    6,032





    Fair value adjustments on derivative financial instruments





    (344)



    (104)

    Fair value losses (gains) on financial assets at fair value through profit or loss



    94



    (27)



    137

    Exchange differences and revaluation of bank deposits



    101



    24



    138





    19,174



    3,893



    2,939

    Changes in assets and liability items:













    Decrease (increase) in trade receivables



    (27,439)



    (258)



    570

    Decrease (increase) in prepaid expenses and other receivables



    (3,277)



    (368)



    1,414

    Increase in inventories



    (4,644)



    (1,113)



    (116)

    Increase (decrease) in accounts payable



    7,369



    860



    (1,481)

    Increase (decrease) in accrued expenses and other liabilities



    19,335



    (2,726)



    722

    Increase in allowance for deductions from revenue



    17,076



    1,267



    310





    8,420



    (2,338)



    1,419

    Net cash used in operating activities



    (48,579)



    (40,749)



    (34,462)

    INVESTING ACTIVITIES:













    Purchase of fixed assets



    (406)



    (168)



    (23)

    Purchase of intangible assets



    (53,368)



    (35)



    (35)

    Change in investment in current bank deposits



    10,200



    (2,069)



    4,869

    Purchase of financial assets at fair value through profit or loss





    (4,325)



    (6,976)

    Proceeds from sale of financial assets at fair value through profit or loss



    7,925



    11,761



    7,517

    Net cash provided by (used in) investing activities



    (35,649)



    5,164



    5,352

    FINANCING ACTIVITIES:













    Proceeds from issuance of ordinary shares, net of issuance costs



    23,867



    36,300



    41,902

    Exercise of options into ordinary shares



    52



    5



    361

    Proceeds from long-term borrowings, net of transaction costs



    78,061





    Increase in restricted cash



    (20,000)





    Decrease in restricted cash



    4,000





    Payment of principal with respect to lease liabilities



    (1,610)



    (796)



    Repayment of payable in respect of intangible asset purchase







    (500)

    Net cash provided by financing activities



    84,370



    35,509



    41,763

     INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS



    142



    (76)



    12,653

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS



    130



    94



    (103)

    BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD



    29,023



    29,005



    16,455

    BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD



    29,295



    29,023



    29,005

    SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH



    414



    753



    728

    SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH



    6,654



    251



    SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:













    Acquisition of right-of-use assets by means of lease liabilities



    2,930



    2,805



    Purchase of intangible assets posted as payable



    24,619





    Purchase of an intangible asset in consideration for issuance of shares



    1,914



    11,788



     

    ____________________________

    [1] Including cash, cash equivalents, short-term investments (bank deposits and financial assets at fair value) and restricted cash.

    [2] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.

    [3] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

    [4] Aemcolo (rifamycin) indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com

    [5] Opaganib (ABC294640, Yeliva®) is an investigational new drug, not available for commercial distribution.

    [6] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

    [7] RHB-204 is an investigational new drug, not available for commercial distribution.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-provides-fourth-quarter-and-full-year-2020-financial-results-and-operational-highlights-301250022.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
View All Redhill Biopharma Ltd. News