RDHL Redhill Biopharma Ltd.

3
+0.15  (+5%)
Previous Close 2.85
Open 2.98
52 Week Low 2.57
52 Week High 11.52
Market Cap $140,175,414
Shares 46,725,138
Float 46,725,138
Enterprise Value $165,656,644
Volume 525,752
Av. Daily Volume 956,161
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Upcoming Catalysts

Drug Stage Catalyst Date
RHB-107 (upamostat)
COVID-19 (outpatients)
Phase 2/3
Phase 2/3
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Opaganib - (MUSC Trial)
Prostate Cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
YELIVA (Opaganib)
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 preliminary top-line data results did not meet its primary endpoint September 14, 2021. Phase 2/3 data showed 62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients, noted October 4, 2021.
RHB-204
Nontuberculous mycobacteria (NTM) infections
Phase 3
Phase 3
Phase 3 trial initiation announced November 20, 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 top-line data released June 14, 2017 - primary endpoint met.
YELIVA (Opaganib)
Cholangiocarcinoma
Phase 2a
Phase 2a
Phase 2a enrolment is ongoing - August 26 2021.
YELIVA (Opaganib)
COVID-19
Phase 2a
Phase 2a
Phase 2 initial data released December 31, 2020.
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., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on 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

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on 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
    .

    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 ( 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.

    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

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

     

    [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:https://www.prnewswire.com/news-releases/redhill-biopharma-to-host-third-quarter-2021-financial-results-and-operational-highlights-webcast-on-november-30-2021-301431479.html

    SOURCE RedHill Biopharma Ltd.

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  2. TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of the previously announced underwritten public offering of approximately 4.7 million American Depositary Shares ("ADSs") for gross proceeds of approximately $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs were offered by RedHill. In addition, RedHill has granted the underwriter a 30-day option to purchase up to approximately an additional 0.7 million ADSs.

    RedHill_Biopharma_Logo

    Cantor…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of the previously announced underwritten public offering of approximately 4.7 million American Depositary Shares ("ADSs") for gross proceeds of approximately $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs were offered by RedHill. In addition, RedHill has granted the underwriter a 30-day option to purchase up to approximately an additional 0.7 million ADSs.

    RedHill_Biopharma_Logo

    Cantor Fitzgerald & Co. acted as sole bookrunner for the offering. SMBC Nikko Securities America, Inc. acted as a financial advisor to the Company.

    RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

    The securities described above were offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

    The final prospectus supplement and the accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC's website at http://www.sec.gov. Alternatively, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

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

    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 (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.

    Forward-Looking Statements

    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, delays in obtaining required stock exchange or other regulatory approvals, share price volatility and the impact of general business and economic conditions; the risk that the follow up for Part A and the commencement of Part B of the Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, 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 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.

    LOGO: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    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 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:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-closing-of-15-5-million-public-offering-of-american-depositary-shares-301430984.html

    SOURCE RedHill Biopharma Ltd.

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  3. TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the underwriter a 30-day option to purchase up to an additional 0.7 million ADSs.

    RedHill Biopharma Logo

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

    The underwriter may offer the ADSs from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On November 18, 2021, the last sale price of the ADSs as reported on the Nasdaq Global Market was $3.88 per ADS.

    RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

    The securities described above are being offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

    A preliminary prospectus supplement relating to the offering was filed with the SEC on November 18, 2021 and is available on the SEC's website at http://www.sec.gov. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC's website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that RedHill has filed (or will file) with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about RedHill and the offering. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

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

    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 adults1Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. 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.

    Forward-Looking Statements

    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, risks and uncertainties associated with the Company's satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, share price volatility and the impact of general business and economic conditions; the risk that the follow up for Part A and the commencement of Part B of the Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, 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 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 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.

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

     

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-pricing-of-15-5-million-public-offering-of-american-depositary-shares-301429090.html

    SOURCE RedHill Biopharma Ltd.

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  4. TEL AVIV, Israel and RALEIGH, N.C., Nov. 18, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced an underwritten public offering of American Depositary Shares ("ADSs"). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an additional 15 percent of the number of ADSs offered in the public offering.

    RedHill Biopharma Logo

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

    RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 18, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced an underwritten public offering of American Depositary Shares ("ADSs"). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an additional 15 percent of the number of ADSs offered in the public offering.

    RedHill Biopharma Logo

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

    RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

    The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form S-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

    The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

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

    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 adults1Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. 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.

    Forward-Looking Statements

    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, risks and uncertainties associated with the Company's satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, share price volatility and the impact of general business and economic conditions; the risk that the follow up for Part A and the commencement of Part B of the Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, 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 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.

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  5. RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients

    Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22

    RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants

    In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted

    RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients

    Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22

    RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants

    In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other territories, ahead of planned regulatory advice

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 15, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.

    The Phase 2/3 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 study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is 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 randomized on a 1:1:1 basis to receive one of two doses of upamostat or placebo. Based on safety and tolerability results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs. placebo. Patients are also tested for specific viral strain. 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.

    "Once again, we see a rise in COVID-19 infections in many countries across the world - and the need for effective, simple and safe oral therapies that can be used outside the hospital setting, and that can work across COVID-19 variants, is significant," said Terry F. Plasse MD, Medical Director at RedHill. "Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step forward for this elegant, once-daily novel oral pill as a potential treatment of COVID-19 in the community."

    RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. 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 and Phase 2 studies in different indications, in approximately 200 patients.

    In parallel, data packages for opaganib[2], RedHill's other advanced novel oral COVID-19 drug candidate - have been submitted to regulators in various territories including the U.S., EU, UK and others, ahead of planned regulatory advice. Opaganib's global Phase 2/3 study in patients hospitalized with severe COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge in a sub-group of 251 moderately severe patients, comprising 54% of the study participants.

    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 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[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 ( 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.

    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 that the follow up for Part A and the commencement of Part B of the Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, 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

    Category: R&D


    [1] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.

    [2] Opaganib is an investigational new drug, not available for commercial distribution in the United States.

    [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.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd



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