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RedHill Initiates First Community-Setting Warranty Program to Refund Talicia Non-Responders
https://finance.yahoo.com/news/redhill-initiates-first-community-setting-110000513.html
RedHill commits to reimburse out-of-pocket costs for Talicia patients that complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing - warranty commitment extends to all commercially insured or non-insured Talicia patients[1]
Talicia warranty program believed to be the first of its kind offered for a widespread community (non-hospital) treated condition, lowering the bar for patient access to an H. pylori therapy with a demonstrated more than 90% cure rate in the confirmed adherent population
Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists[2], is an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population[3]
RALEIGH, N.C. and TEL AVIV, Israel, March 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the availability of a warranty program for its Helicobacter pylori (H. pylori) eradication therapy, Talicia®[4], in which RedHill commits to reimburse patient out of pocket costs should Talicia not work. Talicia is the most prescribed branded agent by gastroenterologists[2] and this warranty commitment extends to all commercially insured and non-insured Talicia patients who complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing.
Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer said: "H. pylori is the number one risk factor for gastric cancer and a major risk factor for development of peptic ulcers, including bleeding ulcers which could require hospitalization[5], [6]. In a pivotal clinical trial, Talicia demonstrated a more than 90% cure rate in patients in the confirmed adherent population and 84% in the intent-to-treat population, with a less than 1% discontinuation rate. Our clinical trial data support a high degree of confidence in both the efficacy and tolerability of Talicia[4], [7]. We are committed to working towards all appropriate patients having access to this important medication and, to our knowledge, this is the first time a warranty program has been offered for a widespread community (non-hospital) treated condition and should serve to lower the bar for patient access."
Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[8]. Other studies have also shown that for clarithromycin-resistant strains of H. pylori the risk of eradication failure increases 3-7–fold when treated with clarithromycin-containing regimens[9],[10]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient BMI or diabetic status, neither of which impact Talicia's eradication rates[11],[12].
In 2017 the American College of Gastroenterology guidelines were changed to recommend against using clarithromycin in the majority of situations[5], in particular where there is known resistance or increased risk for resistance, including any previous H. pylori treatment or treatment for any reason with a macrolide antibiotic (e.g. erythromycin, clarithromycin, azithromycin), which accounts for approximately 100 million Americans every four years[13].
About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[2] of the U.S. population, with an estimated two million patients treated annually[14]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[15] and a major risk factor for peptic ulcer disease[16] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[17]. More than 27,000 Americans are diagnosed with gastric cancer annually[18]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[2].
About Talicia
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[19] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[20]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
TALICIA: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.
You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:
Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.
Call your healthcare provider immediately if while taking Talicia you develop:
New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.
Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
You may experience a brown-orange discoloration of your urine or tears while taking Talicia.
The information here is not comprehensive. Talk to your healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is a prescription medicine for the treatment of a bacteria, Helicobacter pylori (H. pylori), in the stomach of adults.
Click here for the full Prescribing Information for TALICIA.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Understandable!
I am about ready to give up on this stock at this point. It is nothign but bad news after bad news.
From bad to worse, from
worse to worst!
Man this is just brutal. It just keeps getting worse.
RedHill Biopharma Announces Plan to Implement ADS Ratio Change
https://finance.yahoo.com/news/redhill-biopharma-announces-plan-implement-221500180.html
TEL AVIV, Israel and RALEIGH, NC, March 16, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it plans to implement a ratio change of the Company's American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing ten (10) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares. The anticipated first date of the ratio change is on or about March 23, 2023, and the Company's ADSs will continue to be traded on the Nasdaq Global Market ("Nasdaq") under the symbol "RDHL" with a new CUSIP Number 757468202.
For ADS holders, the ratio change will have the same effect as a one-for-forty reverse ADS split. No new ADSs will be issued in connection with the change in the ADS ratio. ADS holders will not be required to take any action and, on the effective date, the Bank of New York Mellon, the depositary bank for RedHill's ADS program, will arrange for the exchange of every forty (40) existing ADSs held for one (1) new ADS.
No fractional new ADSs will be issued in connection with the change in the ADS ratio. Instead, fractional entitlements to new ADSs will be aggregated, and the depositary bank will attempt to sell them with the net cash proceeds from the sale of the fractional ADS entitlements to be distributed to the applicable ADS holders by the depositary bank.
On October 18, 2022, the Company announced that it had received notification from the Nasdaq Stock Market, LLC that it did not comply with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Global Market. The Company anticipates that after the ratio change, the price of its ADS will increase proportionally and meet the Nasdaq minimum bid price requirement, however there can be no assurance that such an increase will occur.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today informs its investors that it does not have exposure to Silicon Valley Bank. The Company or its subsidiaries do not hold cash, cash equivalents, restricted cash, securities or investments at Silicon Valley Bank, and do not otherwise have a business relationship with Silicon Valley Bank.
Your calc seems just about correct,
otoh, beggars can't be choosers.
VERY roughly: 6 million plus 8%, divided by .195 conversion price (93% of .21), it’s about 33 million shares, whereas iHub shows an OS of approx. 91 million. 33/91
dilution around 36%
So, dilution around 36% not counting warrants?
RedHill Biopharma Announces Definitive Agreement for Up To $6 Million Private Placement with a Single Investor
https://finance.yahoo.com/news/redhill-biopharma-announces-definitive-agreement-000500436.html
TEL AVIV, Israel and RALEIGH, NC, March 8, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced agreement, with a single investor, for the issuance of convertible promissory note in the principal amount of up to $6 million, convertible into American Depositary Shares ("ADS") and warrants to purchase ADSs of the Company, pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended.
Gross proceeds to the Company under the promissory note will be up to $6 million, subject to certain conditions, before costs and fees, including prepaid interest of eight (8%) percent. Advances under the promissory note are to be made in three tranches of $2 million, $1 million, and $3 million, respectively. The first tranche will be paid upon closing, and the second and third tranches will be advanced following effectiveness of a registration statement that the Company will file with the Securities and Exchange Commission covering the resale of ADSs to be acquired by the investor under the convertible promissory note and the warrants. The promissory note has a one-year term and must be converted by the end of the term. The conversion price of the promissory note is 93% of the closing price of the Company's ADSs on the trading day immediately preceding the date of any conversion by the investor.
The number of warrants to be issued will be one-fourth of the value of each tranche divided by $0.21, today's ADS closing price. Each warrant will have a term of three years commencing six months following closing and have an exercise price equal to $0.21.
RedHill intends to use the net proceeds from this placement for general working capital, acquisitions, research and development and general corporate purposes.
The convertible promissory note and warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the promissory note and the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other 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 Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1], and Aemcolo®, for the treatment of travelers' diarrhea in adults[2]. 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 broad-acting, host-directed, SPHK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a nuclear radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102, with expected UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the expected tranches of the convertible note and the proposed use of proceeds. 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 growth in prescriptions will not continue and the addition of new generating products will not occur, that we will not be successful in obtaining non-dilutive development funding for RHB-107, that we will not be successful in increasing sales of our commercial products, including due to market conditions, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (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 17, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
[1] 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.
[2] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-definitive-agreement-for-up-to-6-million-private-placement-with-a-single-investor-301766390.html
SOURCE RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that, based on unaudited and preliminary estimates, its total net revenues for the quarter ended December 31, 2022 were in the range of $13.5 million to $15.5 million, compared to $22.1 million in the quarter ended December 31, 2021.
The Company further estimates that its operating loss for the quarter ended December 31, 2022, was in the range of $9.5 million to $11.5 million, compared to $20.7 million in the quarter ended December 31, 2021.
The Company’s current estimate of net cash used in operating activities for the fourth quarter ended December 31, 2022 is in the range of $2 million to $4 million, compared to $14.9 million in the quarter ended December 31, 2021.
The above-estimated revenue, operating loss and cash flow figures for the quarter ended December 31, 2022 reflect RedHill’s current preliminary review, which is still ongoing and could result in changes to the estimated revenues and operating loss figures.
As of December 31, 2022, RedHill’s cash, short-term investments and restricted cash were approximately $36.1 million, compared to $31.4 million as of September 30, 2022.
The foregoing estimates are unaudited and preliminary, have not been reviewed by the Company’s auditors and do not present all information necessary for a full understanding of the Company’s financial condition as of December 31, 2022. The audit of the Company’s consolidated financial statements as of December 31, 2022 is ongoing and could result in changes to these amounts due to the completion of financial closing procedures, final adjustments and other developments that may arise between now and the time the consolidated financial statements as of December 31, 2022, are finalized and publicly released. The Company’s auditor, Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited, an independent registered public accounting firm, has not audited, reviewed, or compiled these estimates.
I have a feeling that a stockpiling
contract worth a few $$$ million
will be announced in the coming
weeks by BARDA/RDHL, thus
adding a new stream of a much
needed revenue for RDHL.
IMHO.
RedHill's Opaganib Selected by the NIH Radiation and Nuclear Countermeasures Program
https://finance.yahoo.com/news/redhills-opaganib-selected-nih-radiation-120000583.html
The National Institutes of Health's (NIH) Radiation and Nuclear Countermeasures Program (RNCP) has selected opaganib for testing via their radiation medical countermeasures Product Development Support contract as a potential treatment for Acute Radiation Syndrome (ARS)
The RNCP is tasked with accelerating development of medical countermeasures for radiation injuries resulting from exposure during a radiological or nuclear public health emergency. As part of this collaboration with RedHill, studies will be undertaken to validate opaganib's efficacy in established pre-clinical animal models of ARS
The Company expects research support provided by the RNCP collaboration to significantly accelerate and enhance the development program for opaganib, allowing access to key research models and resources
Selection by the RNCP follows recent U.S Food and Drug Administration (FDA) guidance to RedHill about the applicability of the Animal Rule regulatory pathway for opaganib for ARS, utilizing pivotal animal model efficacy studies and human safety instead of human efficacy trials
RedHill will work closely with the RNCP on development of opaganib as a potential radiation medical countermeasure. Additional collaboration discussions with other U.S. agencies and other governments are ongoing
Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use in mass casualty radiological or nuclear incidents, if approved by the FDA
TEL AVIV, Israel and RALEIGH, N.C., Feb. 28, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Radiation and Nuclear Countermeasures Program (RNCP), of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has selected opaganib1 for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models.
Dror Ben-Asher, CEO of RedHill Biopharma, said: "The selection of opaganib by the RNCP for studies in its product development pipeline for ARS provides an important validation of opaganib's potential for that indication. The RNCP collaboration is expected to significantly accelerate and enhance the opaganib development program, allowing access to key research models and the resources required to undertake such testing. This exciting development follows last week's news regarding the applicability of the Animal Rule development pathway to opaganib for ARS, emanating from our recent FDA Type-B meeting. RedHill is looking forward to working with both the RNCP and FDA on the development and approval of opaganib as a potential radiation medical countermeasure. In addition, we are continuing our collaboration discussions with other U.S. Government agencies and other governments regarding opaganib for ARS, COVID-19 and other indications."
In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells. The molecule is believed to reduce inflammatory damage to normal tissue and thus suppress toxicity from unintended ionizing radiation exposure and promote viability and robustness of hematopoietic stem cells. A recent publication in the International Journal of Molecular Sciences, entitled "Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy" describes the collective results of eight U.S. Government-funded in vivo studies by RedHill and Apogee Biotechnology Corporation ("Apogee"), as well as additional experiments, establishing opaganib's potential radiation protection capabilities2. In the relevant study models, opaganib was associated with protection of normal tissue, including the gastrointestinal (GI) tract, from damage due to ionizing radiation exposure from total-body exposure or targeted cancer radiotherapy. Additional independent studies demonstrate the role of inhibition of sphingosine kinase-2 (SPHK2), the target of opaganib, in radioprotection in bone marrow, with knockout of SPHK2 showing enhanced survival in mice irradiated with lethal models of whole-body radiation3.
Opaganib, a novel, oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use in mass casualty nuclear radiation incidents, if approved.
About Acute Radiation Syndrome (ARS)
ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, public health emergencies, such as a nuclear power plant accident or detonation of a nuclear device, could affect large numbers of people. ARS is an acute illness caused by irradiation of the body by a high dose of penetrating radiation in a short period of time. Much of the damage caused by ARS is caused by inflammation secondary to the direct effects of ionizing radiation itself.
Current treatments for ARS are supportive care, including blood transfusions, antibiotics, etc., as well as the availability of four approved products (three growth factors to address neutropenia and one to mitigate thrombocytopenia). However, other radiation-induced clinical manifestations that have been observed in natural history studies and remain unaddressed with the current treatments include GI-ARS, cutaneous injury, and late effects in the lung, heart, and kidneys. Opaganib, an SPHK2 inhibitor, may offer a new therapeutic approach to mitigate both hematopoietic-ARS and GI-ARS. It has also been reported in the literature that inhibition of SPHK2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of SPHK2 with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity. The SPHK2 inhibitor is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Opaganib is also being developed as a host-directed antiviral against SARS-CoV-2 and other viruses and has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma. A Phase 2a study in advanced cholangiocarcinoma and a prostate cancer study is ongoing. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use.
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, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4, and Aemcolo® for the treatment of travelers' diarrhea in adults5. 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 broad-acting, host-directed, SPHK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a nuclear radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102, with expected UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that the development of opaganib as part of the RNCP Product Development Pipeline may not be completed or successful; the risk that opaganib will not be shown to elevate ceramide and reduce sphingosine 1-phosphate (S1P) in cells, increasing the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation in an oncology & radiological setting; the risk that the FDA may not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that opaganib will not be shown to be broad acting, host-directed candidate therapies for pandemic preparedness; the risk that a pivotal Phase 3 trial for opaganib will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications; the risk that additional COVID-19 studies for opaganib are required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients; 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 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 17, 2022, and the Company's Report on Form 6-K filed with the SEC on November 10, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
1 Opaganib is an investigational new drug, not available for commercial distribution.
2 Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. https://doi.org/10.3390/ijms232113191.
3 Li C. et al., Loss of Sphingosine Kinase 2 Promotes the Expansion of Hematopoietic Stem Cells by Improving Their Metabolic Fitness. Blood. October 2022;140(15):1686-1701.
4 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.
5 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhills-opaganib-selected-by-the-nih-radiation-and-nuclear-countermeasures-program-301757732.html
SOURCE RedHill Biopharma Ltd.
A lot better than RDHL, but it does
not mean too much, i have been
wrong numereous times
So, how do you feel about PLX?
The Company believes that delisting its common stock from the TASE will allow management to focus better on the Company's primary capital market and reduce its cost of operations as the Company will be subject to only one set of listing rules and regulations. Accordingly, the Company has requested that the TASE immediately initiate the delisting process.
What reason was that?
good morning how ya do'ins my friend
RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome
https://finance.yahoo.com/news/redhill-biopharma-announces-positive-fda-120000236.html
FDA provided guidance on opaganib's regulatory pathway under the Animal Rule for Acute Radiation Syndrome (ARS)
The FDA's Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible
Opaganib is an oral, novel, highly stable, small molecule pill with a five-year shelf life that is potentially suitable, if approved, for central stockpiling by governments against mass casualty nuclear radiation incidents
RedHill plans to work closely with the FDA on development of opaganib as a nuclear medical countermeasure and is set to continue to collaborate with a range of U.S. agencies and other governments on this and other indications
Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher
TEL AVIV, Israel and RALEIGH, N.C., Feb. 15, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the positive outcome of a scheduled Type B meeting with the U.S. Food and Drug Administration (FDA) for the development of opaganib for Acute Radiation Syndrome (ARS) in which the FDA provided guidance on opaganib's developmental pathway to potential approval under the Animal Rule.
"We are pleased to align with the FDA on the Animal Rule development pathway for opaganib for ARS. The FDA has provided very helpful guidance regarding the applicability in the case of opaganib of pivotal animal model efficacy studies in place of human clinical trials, and we plan to work closely with them to advance the development program in support of opaganib as a nuclear medical countermeasure," said Dr Mark Levitt, MD, PhD, Chief Scientific Officer at RedHill. "Given the promising data already generated with opaganib for ARS, we are set to continue collaborating with a range of U.S. agencies in addition to discussions with other governments."
A recent publication in the International Journal of Molecular Sciences, entitled "Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy", describes the collective results of eight U.S. government-funded preclinical in vivo studies by RedHill and Apogee Biotechnology Corporation ("Apogee"), as well as additional experiments, indicating opaganib's1 potential nuclear radiation protection capabilities2. In the relevant study models, opaganib was associated with protection of normal tissue, including gastrointestinal tissue, from radiation damage due to ionizing radiation exposure or cancer radiotherapy. Additional independent studies demonstrate the potential role of inhibition of sphingosine kinase-2 in radioprotection in bone marrow, with knockout of sphingosine kinase-2 correlated with enhanced survival following both lethal and half-lethal whole-body radiation3. Sphingosine kinase-2 is the target of opaganib. Opaganib's protection is not expected to be limited to specific radioactive materials or individual parts of the body.
Opaganib, an oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting, if approved, potential central government stockpiling for use in mass casualty nuclear radiation incidents. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher.
About Acute Radiation Syndrome (ARS)
ARS, sometimes known as radiation toxicity or radiation sickness, is generally rare; however, one event, such as a nuclear power plant disaster, can affect very large numbers of people. ARS is an acute illness caused by irradiation of the body by a high dose of penetrating radiation in a short period of time (usually a matter of minutes). Much of the damage caused by ARS is caused by inflammation secondary to the effects of ionizing radiation itself.
There are four stages of ARS:
Prodromal stage – characterized by nausea, vomiting, anorexia and diarrhea (depending on dose), occurring within minutes to days post-exposure
Latent stage – where the patient may look and feel generally healthy for a period lasting from a few hours up to a few weeks
Manifest illness stage – symptoms for which can vary according to the focus of the radiation damage (i.e. bone marrow, gastrointestinal, cardiovascular, etc.) and can last from hours up to several months
Recovery or death - most patients who do not recover are expected to die within several months, or less, of exposure
Current treatment of ARS is generally limited to supportive care, including blood transfusions, antibiotics, colony-stimulating factors, or stem cell transplantation – with very few options available to treat or prevent the damage caused by radiation exposure. Opaganib, which may offer a new therapeutic approach, is a sphingosine kinase-2 (SK2) inhibitor thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting the possibility of increased survival.
About the FDA Animal Rule
The use of the Animal Rule is intended for drugs developed to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances.
The Animal Rule allows for the use of pivotal animal model efficacy studies when human clinical trials are not ethical or feasible. In such cases efficacy is established using well-controlled studies in animal models of the human disease, with safety being evaluated under the preexisting requirements for drugs.
Products approved under the Animal Rule are critical for the protection of public health and national security, and to date 13 drugs have previously been approved under the Animal Rule.
About Opaganib (ABC294640)
Opaganib a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.
Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SK2, DES1 and GCS).
In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.
Opaganib is also being developed as a host-directed antiviral against SARS-CoV-2 and other viruses, has received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and has undergone a Phase 2a study in advanced cholangiocarcinoma and a prostate cancer study is ongoing. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for IND submission.
Opaganib has demonstrated broad-acting, host-directed, antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal 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, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4, and Aemcolo® for the treatment of travelers' diarrhea in adults5. 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 broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-102, with expected UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that opaganib will not be shown to elevate ceramide and reduce sphingosine 1-phosphate (S1P) in cells, increasing the antitumor efficacy of radiation while concomitantly suppressing inflammatory damage to normal tissue, leading to the potential to suppress toxicity from unintended ionizing radiation (IR) exposure and improve patient response to chemoradiation in an oncology & radiological setting, the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials, the risk that opaganib will not be shown to be broad acting, host-directed candidate therapies for pandemic preparedness, the risk that the Company will not be successful in collaborating with U.S. agencies and other governments, the risk that a pivotal Phase 3 trial for opaganib will not be initiated or that such trial be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, 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 17, 2022, and the Company's Report on Form 6-K filed with the SEC on November 10, 2022. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
1 Opaganib is an investigational new drug, not available for commercial distribution.
2 Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. https://doi.org/10.3390/ijms232113191.
3 Li C. et al., Loss of Sphingosine Kinase 2 Promotes the Expansion of Hematopoietic Stem Cells by Improving Their Metabolic Fitness. Blood. October 2022;140(15):1686-1701.
4 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.
5 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-positive-fda-meeting-regarding-opaganib-for-acute-nuclear-radiation-syndrome-301747424.html
SOURCE RedHill Biopharma Ltd.
I have just reminded that RDHL too was
dual traded just a couple years ago.
RDHL voluntarily delisted from TASE
for the same reasons PLX have.
Raleigh pharma sheds debt in exchange for top-selling drug. Now what?
https://www.bizjournals.com/triangle/news/2023/02/10/redhill-exchanges-movantik-to-healthcare-royalty.html?utm_source=sy&utm_medium=nsyp&utm_campaign=yh
By Zac Ezzone – Staff writer, Triangle Business Journal
Feb 10, 2023
A Raleigh pharmaceutical company is moving forward after exchanging the rights to its top commercial asset for the cancelation of more than $100 million in debt obligations.
RedHill Biopharma (Nasdaq: RDHL) announced Monday it has reached an agreement to transfer its drug Movantik to Connecticut-based HealthCare Royalty Partners. The deal extinguishes all of RedHill's debt obligations from a credit agreement the two parties signed three years ago.
That agreement was worth up to $115 million, of which RedHill received $30 million to support its commercial operations and another $50 million to fund the acquisition of Movantik in early 2020 from the global biotech AstraZeneca (NYSE: AZN).
But the emergence of the Covid-19 pandemic hindered RedHill's launch of the drug – a treatment for constipation caused by prescription pain medicines. As a result, the company struggled to meet its pre-Covid sales projections and its debt became burdensome, said CEO Dror Ben-Asher.
RedHill's stock has dropped more than 90 percent from a year ago and closed Thursday at $0.22 a share.
RedHill and HealthCare Royalty in November initially reached a non-binding agreement that would extinguish RedHill's debt obligations — which included $80 million the company borrowed and other items, such as exit and royalty fees — in exchange for the rights to Movantik. With the deal finalized, RedHill transferred its rights in the drug to Movantik Acquisition Co., an affiliate of HealthCare Royalty. HealthCare Royalty will also pay RedHill for up to a year for services that support the transition of Movantik to ensure patient access to the drug isn't interrupted.
Sales from Movantik made up the bulk of RedHill's revenue during the first nine months of last year. From January through September, revenue from sales of the drug totaled about $41.5 million, ahead of licensing revenue at $2 million and sales of other products at about $5.5 million, according to RedHill's third quarter earnings report. The company ended the quarter with a cash balance of $31.4 million.
Despite losing its top revenue source, Ben-Asher says the deal puts the company in a good position. RedHill emerges from the deal debt free, with two commercial products and a pipeline of drug candidates.
RedHill plans to replace the revenue lost from Movantik by ramping up commercial efforts of its two approved products.
The U.S. Food and Drug Administration approved the company's product Talicia — a treatment for Helicobacter pylori infection — in November 2019. But the drug never received the launch it deserved, Ben-Asher says. During the Covid-19 pandemic, the number of colonoscopies performed decreased significantly, which is how the infection is diagnosed.
The company's other product, Aemcolo — a treatment for traveler's diarrhea — was similarly affected by the pandemic. RedHill initiated its U.S. promotion of the drug in December 2019, shortly before the the travel industry began experiencing sharp declines related to the pandemic.
But both of these issues seem to be lessening, with the travel industry gradually recovering and patients again seeking health care services they may have put off during the pandemic, Ben-Asher said.
"We are confident that we can grow (the products) much faster," Ben-Asher said.
RedHill, which bases its corporate headquarters in Israel and its commercial headquarters in Raleigh, is also looking to bring in revenue-generating products through acquisitions. Ben-Asher said the company is engaged in discussions for several drugs that are synergistic with RedHill's existing products.
RedHill in December closed an $8 million public offering, the proceeds of which will cover services related to the HealthCare Royalty agreement, while also providing the company with working capital and funds to support potential drug acquisitions.
The company isn't making any changes to the size of its commercial team after moving on from Movantik. RedHill cut about 50 jobs last summer as part of a cost reduction plan, leaving the company with just under 100 people based out of its Raleigh office. This team is critical in RedHill promoting its existing products and the new ones the company hopes to add, Ben-Asher said.
As it moves forward with its commercial plans, RedHill is also in discussions with various governments as it searches for partners to support late stage studies of drug candidates in the company's pipeline, Ben-Asher says. This includes opaganib, an oral small molecule drug that RedHill aims to develop in multiple indications.
The company is seeking to include the drug in a government-funded platform study as a potential treatment for hospitalized Covid-19 patients. RedHill is also discussing with government agencies potential development pathways of the drug as a treatment for nuclear radiation injury.
In addition to opaganib, RedHill is focusing its clinical development efforts on two other drug candidates, RHB-107 and RHB-204. But further advancement of these programs would also likely rely on partnerships or additional resources. The company is looking to partner with a government agency to evaluate the former as a treatment for nonhospitalized Covid-19 patients in a late-stage study, while the latter is being evaluated in a phase 3 trial as a treatment for pulmonary nontuberculous mycobacteria, or NTM, disease. RedHill is funding this study on its own, but is in discussions with other companies about a potential partnership.
Despite a difficult period, Ben-Asher is optimistic about the company's prospects.
"We had a setback ... launching three drugs during Covid," Ben-Asher said. "But being a debt free company now, and with these products, and the additional products we're bringing in, with this kind of pipeline, we're emerging out of this crisis in a very interesting way."
Sure is depressing unless he get some sort of massive news this stock seems stuck under .30 cents.
Not nearly as hated as some others...
This day will come some day.
(I am trying real hard to convince
myself it will happen)
Boy what in the world will it take for this stock to come back. I just want to get back to a buck so I can get my money out but man is this stock hated.
RDHL, 1 step forward,
2 steps backward.
Sigh.
Finally! This was somewhat overdue and glad it has come to fruition. I was getting a little concerned.
https://finance.yahoo.com/news/redhill-biopharma-healthcare-royalty-agree-120000005.html
At least we don't have to worry about the potential for that debt anymore and things can move on.
Hoping for better pastures coming in the not too distant future.
Still highly frustrated with management for letting this happen, and with HCR for being a less than friendly partner in all this and taking advantage of the situation.
To the future!
Correction:
Good News out this morning 2/6/2023. See News tab...
Good News out this morning 2/5/2023. See News tab...
Some do not want to let the baby walk up the RED HILL. $RDHL
Rally continues:
0.2400 +0.0299 (+14.2313%)
Pre-Market: 4:24AM EST
low of day at the end of day....hmmm...
Well, as previously said, perhaps
today is the beginning of a reversal,
After all miracles have happened in
my region.
Stock not stick, obviously.
When a stick has been suppressed/dormant as long as this has, it seems people are often not watching the news closely, and there may be a delayed reaction when a catalyst does occur. I also think “smart money” often analyzes a stock carefully for 2-3 days before moving in.
You’re welcome.
And, only very indirectly.
Thank you carusso.
I was surprised as the pr was published
yesterday, whereas the huge impact took
place today?
Very strange.
Anyway it is not yet an approved treatment,
just a patent, i only can imagine what will happen
to the company once (if) Phase 3 study proves
positive outcomes.
Fingers crossed.
BTW, any relation to Enrico Caruso the great tenor?
Read about “paratuberculosis”, aka Avian tuberculosis, aka Mycobacterium avium.
Big impacts in poultry and cattle industries, agriculture.
https://www.msdvetmanual.com › generalized-conditions › tuberculosis-and-other-mycobacterial-infections › overview-of-tuberculosis-and-other-mycobacterial-infections
Overview of Tuberculosis and other Mycobacterial Infections
M avium avium is the species of most importance in birds, but it has a wide host range and is also pathogenic for pigs, cattle, sheep, deer, mink, dogs, cats, certain exotic hoofed animals, and some cold-blooded animals. M avium hominissuis is the cause of tuberculosis in people, swine, and other animals.
https://www.mdpi.com › 2076-2615 › 10 › 10 › 1773 › htm
Animals | Free Full-Text | Mycobacterium Avium Paratuberculosis: A ...
Mycobacterium avium paratuberculosis is responsible for paratuberculosis or Johne's disease in cows, having economic impacts on the dairy industry and a prevalence rate exceeding 50% in dairy herds. The economic burden of Johne's disease relates to decreased milk production and costs of disease prevention, treatment, and management, while having an economic impact on dairy producers ...
https://www.semanticscholar.org › paper › Economic-impact-of-paratuberculosis-in-dairy-cattle-Hasonová-Pavlik › 5cdf1d112cabbd750fa691a8de087a9d8f74b5a2
[PDF] Economic impact of paratuberculosis in dairy cattle herds: a ...
Economic losses, which may be caused by Mycobac- terium avium subsp. Paratuberculosis (PTB) is a disease which causes considerable economic losses to producers of livestock, particularly dairy cows. Nowadays PTB is one of the most prevailing and costly infectious diseases of dairy cattle. The purpose of the present study was to review economic losses, which may be caused by Mycobac- terium ...
That is a very strange comment.
Care to clarify?
Tia.
That’s big deal for both people and animals in some areas of the world, including some regions in USA
Is today the start of some reversal?
0.2532 +0.0691 (+37.5339%)
Pre-Market: 5:11AM EST
Sure hope so.
"Even a blind squirel can find a nut once in a while."
That brought a smile to my face!
I'm in for the long haul. There's not much I can do now but wait it out.
Even a blind squirel can find a nut once in a while.
Let's hope RDHL finds one, a big one, someday.
I am still in, not much more i can lose.
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
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[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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02-07-2021
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