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daily sma 200@$9.00 lots of run room,no more debt,no wonder its going up!!!!!
Ok I was not sure what the short interest was. But I got a long ways to go just to break even my cost basis was like .95 cents before the split. Heck I thought was a good price at the time.
in past year,every time buy vol. like this it ran well,why would this time be different
relative buying vol. up 29Xs ave. somebody knows something,only 17k short(nothing to cover)
not optionable,eps q/q up 225%,target $40.00
demand rising 16k,no supply,wont be long now,few min maybe
headed to ZERO BORROW,shares to short dropped 400% today,only 10k remain,they letting it go>go>go>up
Honestly incredible, that they have the best anit-H.Pylori product in the world with FDA QIDP designation and they are on a Market Cap of 3 million.
I mean, holy moly, I would never have expected that!
RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights
Q1/23 Talicia net revenues of $3.4 million; Cash balance of $28.8 million as of March 31, 2023[1]; Extinguishment of all debt obligations in exchange for the transfer of rights in Movantik®[2] resulting in net income of $50.2 million for the first quarter of 2023
Opaganib selected by National Institutes of Health for Acute Radiation Syndrome development support contract; RHB-107 outpatient COVID-19 development prioritized, including potential non-dilutive funding, following termination of RHB-204 Phase 3 study due to low accrual rate
TEL AVIV, Israel and RALEIGH, N.C., June 12, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its first quarter 2023 financial results and operational highlights.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "2023 has commenced with purpose and clarity, with a streamlined cost-base and without the restrictive burden of debt. Commercial focus, once the Movantik transition period is complete, will see all efforts aligning to maximize Talicia and potentially secure additional revenue-generating products to further augment our commercial portfolio. There is equal clarity on the R&D front with full focus being applied to opaganib, RHB-107 and RHB-102. Opaganib's current development for Acute Radiation Syndrome is under the guidance and full financial support of the NIH Radiation and Nuclear Countermeasures Program product development contract, while RHB-107's late-stage development for non-hospitalized COVID-19 will benefit from the resources we are able to redirect from the terminated RHB-204 Phase 3 study. Additional antiviral research with NIH and the US Army also continues for both product candidates for pandemic preparedness purposes."
Financial results for the three months ended March 31, 2023 (Unaudited)[3]
Net Revenues for the first quarter of 2023 were $3.6 million, as compared to $12.8 million for the fourth quarter of 2022. The decrease is primarily related to the divestiture of Movantik, resulting in the discontinuation of revenue recognition from this product starting from February 2, 2023. Talicia net revenues for the first quarter of 2023 were $3.4 million, as compared to $2.2 million for the fourth quarter of 2022, primarily due to an increase of 20% in units sold.
Cost of Revenues for the first quarter of 2023 were $1.6 million, as compared to $8.6 million for the fourth quarter of 2022. This decrease can be primarily attributed to the divestiture of Movantik. As a result of this divestiture, both the recognition of revenue and the associated cost of revenues for this product were discontinued starting from February 2, 2023. Additionally, the amortization of the intangible asset related to Movantik was also discontinued as of that date.
Gross Profit for the first quarter of 2023 was $2.0 million, as compared to $4.2 million for the fourth quarter of 2022, in line with the decrease in Net Revenues and Cost of Revenues as explained above and primarily attributed to the divestiture of Movantik.
Research and Development Expenses for the first quarter of 2023 were $1.1 million, consistent with the fourth quarter of 2022.
Selling, Marketing and General and Administrative Expenses for the first quarter of 2023 were $10.9 million, as compared to $13.0 million for the fourth quarter of 2022. The difference was primarily attributable to the successful ongoing cost-reduction measures.
Other Income for the first quarter of 2023 was $39.1 million, as compared to no other income recognized for the fourth quarter of 2022. The other income was comprised of (i) $35.5 million from the sale of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset; and (ii) from transitional services fees provided to the buyer of Movantik.
Operating Income for the first quarter of 2023 was $29.1 million, as compared to an operating loss of $9.9 million for the fourth quarter of 2022, primarily attributed to the changes resulting from the sale of Movantik, as detailed above.
Financial Income, net for the first quarter of 2023 was $21.2 million, as compared to Financial Income, net of $6.2 million for the fourth quarter of 2022. The income recognized in the first quarter of 2023 was primarily related to gain resulting from the extinguishment of the HCR Collateral Management LLC ("HCR") debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred.
Net Income for the first quarter of 2023 was $50.2 million, as compared to Net Loss of $3.7 million for the fourth quarter of 2022, primarily attributed to the changes resulting from the sale of Movantik, as detailed above.
Total Assets as of March 31, 2023, were $58.8 million, as compared to $158.9 million as of December 31, 2022. The decrease was primarily attributable to the sale of Movantik, resulting in the transfer of the rights to Movantik, as well as to a significant decrease in the Trade Receivables balance following the sale of Movantik.
Total Liabilities as of March 31, 2023, were $56.8 million, as compared to $207.3 million as of December 31, 2022. This decrease was primarily due to the extinguishment of HCR debt in exchange for the transfer of Movantik rights, assumption of certain liabilities by HCR, and payments made towards pre-closing liabilities related to Movantik.
Net Cash Used in Operating Activities for the first quarter of 2023 was $7.2 million, as compared to $2.4 million for the fourth quarter of 2022. The difference was primarily attributed to the payments made towards the pre-closing liabilities related to Movantik.
Net Cash Provided by Financing Activities for the first quarter of 2023 was $4.8 million comprised primarily of prepayment from the registered direct offering that closed on April 3, 2023, and the decrease in restricted cash offset by payment in respect of intangible assets purchases.
Cash Balance as of March 31, 2023, was $28.8 million[4].
Business updates
On May 15, 2023, the Company announced that it had received a written notification from the Nasdaq Stock Market LLC ("Nasdaq") dated May 9, 2023, indicating that the Company is not in compliance with the minimum Market Value of Publicly Held Shares ("MVPHS") set forth in the Nasdaq Rules for continued Nasdaq listing. Nasdaq Listing Rule 5450(b)(3)(C) requires companies to maintain a minimum MVPHS of US$15 million, and Listing Rule 5810(c)(3)(D) provides that a failure to meet the MVPHS requirement exists if the deficiency continues for a period of 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the Company has a compliance period of 180 calendar days (or until November 6, 2023) to regain compliance. If at any time during this compliance period the Company's MVPHS closes at US$15 million or more for a minimum of ten consecutive business days, Nasdaq will notify the Company that it has achieved compliance with the MVPHS requirement, and the MVPHS matter will be closed. In the event the Company does not regain compliance with Rule 5450(b)(3)(C) prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. Alternatively, the Company may consider applying to transfer its securities to the Nasdaq Capital Market. This notification does not impact the listing and trading of the Company's securities at this time.
On April 11, 2023, the Company announced that it had received confirmation from Nasdaq that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5450(a)(1), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on April 5, 2023. Listing compliance follows the Company's implementation of a ratio change of the Company's American Depositary Shares ("ADSs") to its non-traded ordinary shares from the previous ratio of one (1) ADS representing ten (10) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares, which the Company announced on March 16, 2023. The ratio change came into effect on March 23, 2023, and the Company's ADSs continue to be traded on Nasdaq under the symbol "RDHL" with a new CUSIP Number 757468202.
On April 3, 2023, the Company announced the closing of a $6 million registered direct offering for the purchase and sale of 1,500,000 of the Company's ADSs (or ADS equivalents), Series A warrants to purchase up to an aggregate of 1,500,000 ADSs and Series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The Series A warrants have an exercise price of $4.75 per ADS, are exercisable immediately and have a term of five years following issuance, and the Series B warrants have an exercise price of $4.00 per ADS, are exercisable immediately and have a term of nine months following issuance. 811,000 ADSs underlying pre-funded warrants purchased at the registered direct offering were exercised following the closing of the offering, announced April 3, 2023. The Company expects to recognize $1.1 million as a financial expense in the second quarter of 2023 due to the difference between the fair value of the warrants arising from the registered direct offering to the transaction price.
On February 6, 2023, the Company announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary, RedHill Biopharma Inc., and HCR, announced February 25, 2020, as amended, in exchange for the transfer of its rights in Movantik® (naloxegol) to Movantik Acquisition Co., an affiliate of HCR. HCR assumed substantially all post-closing liabilities, and RedHill retained substantially all pre-closing liabilities relating to Movantik. As part of the parties' arrangement, and to ensure continuous patient care, RedHill provides HCR with transition services for up to 12 months, paid for by HCR. HCR will retain security interests in certain RedHill assets until substantially all pre-closing liabilities relating to Movantik have been paid or other specific conditions are met.
In the first quarter of 2023, the Company sold 2,625 ADSs through its at-the-market facility at an average price of $7.34 per ADS, for aggregate net proceeds of approximately $20,000.
RedHill continues its litigation against Kukbo Co. Ltd. ("Kukbo") which was filed on September 2022 as a result of Kukbo's default in delivering to RedHill a total of $6.5 million under the Subscription Agreement, dated October 25, 2021 and the Exclusive License Agreement, dated March 14, 2022. Following a recent court decision on RedHill's motion to dismiss Kukbo's counterclaims, which accepted certain claims of RedHill and rejected others, RedHill filed a motion to reargue (a motion to clarify and correct some of the court's rulings). RedHill further plans to continue to rigorously pursue the Kukbo litigation.
RedHill is actively pursuing strategic business development transactions, including potential in-licensing revenue-generating assets in the U.S. and out-licensing certain RedHill development pipeline assets.
Commercial Highlights
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[5]
Q1/23 saw Talicia recording a 9.6% increase in new prescriptions compared to the same period last year, maintaining its place as the leading prescribed branded H. pylori therapy by U.S. gastroenterologists[6].
On May 9, 2023, the Company announced new Talicia PBPK modeling data, published in AP&T Journal[7], showing that generically substituted regimens are non-bioequivalent to Talicia. Separately, new Talicia PBPK modeling data, presented at Digestive Diseases Week (DDW) 2023, supports bioequivalence between TID and Q8H dosing regimens for Helicobacter pylori (H. pylori) eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy.
On March 21, 2023, the Company announced the establishment of a warranty program for Talicia, in which RedHill committed to reimburse patient out of pocket costs should Talicia not work. 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[8]. It is believed that this is the first time a warranty program has been offered for a widespread community (non-hospital) treated condition, lowering the bar for patient access.
Total Talicia coverage stood at more than 202 million American lives as of March 31, 2023.
Aemcolo® (rifamycin)[9]
On December 5, 2022, the Company announced that the FDA Exclusivity Board has granted Aemcolo five years' exclusivity under the FDA's Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data exclusivity, extending regulatory exclusivity through to 2028.
Movantik® (naloxegol)[10]
On February 6, 2023, the ownership of Movantik was transitioned to Movantik Acquisition Co., an affiliate of HCR, in exchange for extinguishment of all RedHill's debt obligations with HCR. Movantik is no longer a RedHill product. Revenues for Movantik were recorded up to and including February 1, 2023.
As part of the agreement, and to ensure continuous patient care, RedHill is providing HCR with transition services for up to 12 months, paid for by HCR.
R&D Highlights
Opaganib (ABC294640)[11] – A novel broad-acting, host-directed oral antiviral targeting radioprotection, COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory indications and oncology.
Nuclear Medical Countermeasures (Acute Radiation Syndrome):
On February 28, 2023, the Company 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 opaganib 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. This follows the February 15, 2023, announcement that the FDA provided guidance on the use of the Animal Rule for opaganib's developmental pathway for Acute Radiation Syndrome (ARS), utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher. These announcements followed publication of data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with[17]:
Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
Additional collaboration discussions with U.S. and other governments are ongoing.
Pandemic preparedness and oncology:
Preclinical development of opaganib, in collaboration with the US Army and NIAID, for various antiviral indications is ongoing.
On May 1, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) had granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.
RHB-107 (upamostat)[12] – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
Outpatient treatment of COVID-19:
On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases[13]. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
Discussions are ongoing for external non-dilutive funding for additional late-stage COVID-19 clinical development.
Pandemic preparedness / additional viral indications:
RHB-107 is also the subject of several cooperative research projects with government and non-government bodies, evaluating RHB-107 against multiple viral targets, including influenza and Ebola (amongst others).
RHB-102 (BEKINDA) – Oncology Support
On May 1, 2023, the Company announced that the European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034.
On February 16, 2023, the Company announced that it held a positive pre-Marketing Authorisation Application meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) with regard to seeking marketing approval for RHB-102 (BEKINDA) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV).
Discussions for potential commercialization partners are ongoing.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease[14] (NTM)
On May 22, 2023, the Company announced the termination of RHB-204's U.S. Phase 3 study for non-tuberculosis mycobacteria (NTM) disease due to a very low accrual rate. This decision is intended to enable the Company to better focus its resources on key pipeline catalysts and revenue-generating product acquisition, while searching for out-licensing partners for RHB-204.
2.3013 ^ 0.1313 (6.05%)
Yesterday and today inching up?
RDHL not completely dead yet?
I wonder!
Back to 52 weeks lows this company is basically just on life support at this point. No revenue and two covid drugs that will most likely fail. All could have been avoided if they did not waste so much omney on the covid nonsense three years ago and cut costs long ago. Now it is totally dead money.
This company is dead how much longer cant the 36 million last anyway? They keep talking about finding revenue generating products yet they never do. Whatever happened to the Crohns disease drug?
RedHill Provides R&D Update
https://finance.yahoo.com/news/redhill-provides-r-d-110000003.html
RedHill has elected to terminate RHB-204's U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to low accrual rate and plans to shift resources to more rapidly advance RHB-107 late-stage development for outpatient treatment of COVID-19
RedHill's advanced pipeline also includes: Opaganib – in collaboration with the U.S. Government's Radiation and Nuclear Countermeasures Program for development as a potential treatment for Acute Radiation Syndrome (ARS) and other indications, RHB-102 – with a potential UK marketing approval submission for oncology support, and additional clinical stage programs
TEL AVIV, Israel and RALEIGH, NC, May 22, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the termination of RHB-204's[1] U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to a very low accrual rate, and the shifting of the Company's resources to advance once-daily, oral RHB-107's[2] late-stage development for outpatient treatment of COVID-19. This decision is intended to enable the Company to better focus its resources on key pipeline catalysts and revenue-generating product acquisition, while searching for out-licensing partners for RHB-204.
"RHB-204 is an innovative potential treatment for a difficult to treat disease with strong unmet medical need and no current stand-alone first-line therapies. We are hugely grateful to the RHB-204 development team, including the Clinical Research Organizations and trial sites, who have designed and implemented a very smart Phase 3 clinical trial, in addition to securing Qualified Infectious Disease Product and orphan drug designations in both the U.S. and EU, along with solid intellectual property coverage for RHB-204," said Gilead Raday, RedHill's Chief Operating Officer, and Head of R&D. "However, due to the very slow enrolment in NTM and given the current state of the financial markets and the negative biotech sector sentiment, we must focus our limited resources where we believe most value can be generated for our shareholders in the short to medium term and, as such, we are prioritizing RHB-107 for non-hospitalized COVID-19 patients and opaganib for Acute Radiation Syndrome."
About RHB-204
RHB-204 is a Phase 3-stage proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC. RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill is seeking protection of RHB-204, and its use in treating pulmonary MAC disease, on a global scale, providing protection until 2041.
Does anyone believe this is a real company anymore? I think it is just an office building with a cardboard sign that says Redhill. These are total con artists plain and simple.
This company is a total scam I wish my buddy never got me into it. I am starting to wonder if it is even a real company anymore. Same old copied and pasted nonsense every three months and no news or anything worthwhile ever. Same old promises that never happen. They clearly are just milking it as long as they can before it folds. That is the only conclusion I can come up with.
I will just sell out at the end of the year this company clearly is a scam and will be out of business within two years. What a complete joke.
RedHill Biopharma Receives NASDAQ Notification Regarding Minimum Market Value of Publicly Held Shares Deficiency
https://finance.yahoo.com/news/redhill-biopharma-receives-nasdaq-notification-221700231.html
TEL AVIV, Israel and RALEIGH, N.C., May 15, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") dated May 9, 2023 indicating that the Company is not in compliance with the minimum Market Value of Publicly Held Shares ("MVPHS") set forth in the Nasdaq Rules for continued Nasdaq listing.
Nasdaq Listing Rule 5450(b)(3)(C) requires companies to maintain a minimum MVPHS of US$15 million, and Listing Rule 5810(c)(3)(D) provides that a failure to meet the MVPHS requirement exists if the deficiency continues for a period of 30 consecutive business days. This notification does not impact the listing and trading of the Company's securities at this time.
Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the Company has a compliance period of 180 calendar days (or until November 6, 2023) to regain compliance. If at any time during this compliance period the Company's MVPHS closes at US$15 million or more for a minimum of ten consecutive business days, Nasdaq will notify the Company that it has achieved compliance with the MVPHS requirement, and the MVPHS matter will be closed.
In the event the Company does not regain compliance with Rule 5450(b)(3)(C) prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting. Alternatively, the Company may consider applying to transfer its securities to the Nasdaq Capital Market.
RedHill Publishes New Talicia® Data on Generic Non-Bioequivalence in AP&T and Presents New Dosing Data at Digestive Disease Week
https://finance.yahoo.com/news/redhill-publishes-talicia-data-generic-110000471.html
New Talicia PBPK modeling data, published in AP&T Journal, showed that generically substituted regimens are non-bioequivalent to Talicia
Separately, new Talicia PBPK modeling data, presented at DDW, supports bioequivalence between TID and Q8H dosing regimens for H. pylori eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy
These new data support Talicia's place as the leading prescribed branded H. pylori therapy by U.S. gastroenterologists[1], and as an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population[2]
RALEIGH, N.C. and TEL-AVIV, Israel, May 9, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced two distinct sets of new Talicia[3] data focused on generic non-bioequivalence and on dosing regimens. The first new dataset, published in the Journal Alimentary Pharmacology and Therapeutics (AP&T) showed that generically substituted regimens are non-bioequivalent to Talicia. The second set of data, presented at Digestive Disease Week (DDW), supports bioequivalence between Talicia TID (three times daily) and Q8H (every eight hours) dosing regimens for H. pylori eradication therapy.
In eradicating H. pylori, previous work has shown the importance of antibiotic exposure at the site of the infection[4]. The recently published data in AP&T[5], entitled 'Physiologically based pharmacokinetic (PBPK) modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection', showed that Talicia 50 mg, three times daily, had higher intragastric exposure times than 150 mg once daily or twice daily, or 300 mg once daily generic rifabutin, achieving significantly longer times with intragastric concentration above MIC90 (22.3 ± 1.1 h) than 150 mg once daily (8.3 ± 1.7 h), 150 mg twice daily (16.3 ± 2.3 h), or 300 mg once daily (8.5 ± 1.9 h) - while also providing the lowest mean maximal plasma concentration and mean area under the plasma concentration–time curve of all regimens studied.
Dr. Colin W. Howden, MD, Professor Emeritus, University of Tennessee Health Science Center, said: "This is one of those occasions where it is important to recognize that generic options are not equivalent to the original. In our study we showed that intragastric exposure times with Talicia, when given three times daily, were consistently higher than the generic options, and that Talicia provided the highest potential for H. pylori eradication based on gastric exposure, since the stomach is the site of H. pylori infection. Given the potential for antibiotic resistance and treatment failure, the non-equivalence of generics shown by these data should be kept front of mind when prescribing first-line therapy for H. pylori eradication."
The data presented at DDW confirm, using PBPK modeling, the bioequivalence of Talicia TID and Q8H dosing for the eradication of H. pylori, with a 90% overlap of intragastric AUC312-336h between TID and Q8H for 14 days. Talicia is currently indicated for Q8H administration.
Dr Nimish Vakil, MD, Clinical Adjunct Professor Gastroenterology & Hepatology, University of Wisconsin School of Medicine and Public Health said: "The PBPK modeling data we have presented supports bioequivalence between Talicia TID and Q8H dosing regimens for H. pylori eradication therapy showing that the overall exposures are comparable for all three Talicia-containing drugs, amoxicillin, rifabutin, and omeprazole. Therapy adherence is one of the most important factors for H. pylori eradication, and as treatment complexity is an established contributing factor to adherence, it is to be expected that the more optimal the treatment regimen, the better the adherence will be, and, subsequently, the better the treatment outcome."
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[6]. 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[7] and a major risk factor for peptic ulcer disease[8] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. 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 therapies2.
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 the key components 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[11] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[12]. 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.
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 adults1, and Aemcolo® for the treatment of travelers' diarrhea in adults[13]. 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, including without limitation the risk that the Company will not succeed to expand Talicia's reach to additional ex-U.S. territories; as well as other risk 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; (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; 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 April 28, 2023. 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: Commercial
[1] IQVIA XPO Data on file
[2] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[3] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[4] K. Satoh et al. Treatment of Helicobacter pylori infection by topical administration of antimicrobial agents. Scand J Gastroenterol Suppl 1996 Vol. 214 Pages 56; discussion 57-60. Accession Number: 8722409. https://www.ncbi.nlm.nih.gov/pubmed/8722409
[5] Howden CW et al. Physiologically based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection. Alimentary Pharmacology and Therapeutics, 20 April 2023. https://doi.org/10.1111/apt.17526
[6] IQVIA Custom Study for RedHill Biopharma, 2019
[7] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[8] NIH – Helicobacter pylori and Cancer, September 2013.
[9] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[10] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[11] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[12] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
[13] 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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RedHill Biopharma (NASDAQ:RDHL) Rating Increased to Hold at StockNews.com
https://www.defenseworld.net/2023/05/07/redhill-biopharma-nasdaqrdhl-rating-increased-to-hold-at-stocknews-com.html
Posted by Defense World Staff on May 7th, 2023
RedHill Biopharma logoRedHill Biopharma (NASDAQ:RDHL – Get Rating) was upgraded by stock analysts at StockNews.com from a “sell” rating to a “hold” rating in a research report issued to clients and investors on Friday.
Institutional Trading of RedHill Biopharma
Several large investors have recently added to or reduced their stakes in RDHL. Morgan Stanley grew its holdings in shares of RedHill Biopharma by 15.0% during the 4th quarter. Morgan Stanley now owns 445,309 shares of the biotechnology company’s stock valued at $62,000 after acquiring an additional 58,128 shares in the last quarter. Renaissance Technologies LLC purchased a new position in shares of RedHill Biopharma during the 4th quarter valued at $49,000. CLARET ASSET MANAGEMENT Corp grew its holdings in shares of RedHill Biopharma by 139.4% during the 4th quarter. CLARET ASSET MANAGEMENT Corp now owns 228,430 shares of the biotechnology company’s stock valued at $32,000 after acquiring an additional 133,000 shares in the last quarter. Virtu Financial LLC grew its holdings in shares of RedHill Biopharma by 44.8% during the 3rd quarter. Virtu Financial LLC now owns 62,182 shares of the biotechnology company’s stock valued at $31,000 after acquiring an additional 19,242 shares in the last quarter. Finally, Millennium Management LLC purchased a new position in shares of RedHill Biopharma during the 2nd quarter valued at $324,000. 5.20% of the stock is owned by institutional investors and hedge funds.
RedHill Biopharma Company Profile
RedHill Biopharma Ltd., a specialty biopharmaceutical company, primarily focuses on gastrointestinal and infectious diseases. The company promotes gastrointestinal drugs, including Movantik for opioid-induced constipation in adults with chronic non-cancer pain; Talicia for the treatment of Helicobacter pylori infection in adults; and Aemcolo for the treatment of travelers' diarrhea in adults.
I thnk RDHL is going to set the record for the company with the most patents and not one single thing to show for it.
RedHill Biopharma Ltd. (the “Company”) announces the appointment of Mr. Ofer Tsimchi, an independent director of the Company, as the interim Chairman of the Board of Directors, effective May 5, 2023, until the next annual or extraordinary general meeting of shareholders of the Company. Mr. Ofer Tsimchi will replace Mr. Dror Ben-Asher, whose appointment as Chairman of the Board of Directors was approved by the Company’s shareholders on May 4, 2020, for a period of three years. The Israeli Companies Law provides that the engagement of a Chief Executive Officer of an Israeli public company also as its Chairman of the Board of Directors requires shareholder approval, and such approval is effective for a period of up to three years.
RedHill's RHB-102 (BEKINDA®) and Opaganib Granted New Patents in Oncology Setting
https://finance.yahoo.com/news/redhills-rhb-102-bekinda-opaganib-110000092.html
European Patent Office grants RHB-102 patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV), providing protection of RHB-102 to March 2034
Discussions with potential commercialization partners for RHB-102 in the UK and other territories are ongoing
US PTO grants new opaganib combination compositions patent for treatment of cancer
TEL AVIV, Israel and RALEIGH, N.C., May 1, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of two new EU and U.S. patents for RHB-102 (BEKINDA)1 and opaganib2, respectively, in the oncology setting.
The European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034.
"Between 70-80% of patients undergoing chemotherapy or radiotherapy will experience nausea and/or vomiting. The global CINV/RINV market is growing at approximately 6% CAGR and is estimated to be worth over $10 billion by 20313," said Guy Goldberg, RedHill's Chief Business Officer. "Following a positive recent UK MHRA scientific advice meeting RHB-102 (BEKINDA) data was deemed supportive of potential submission for marketing approval in the UK for chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV). The Company is also considering the potential for RHB-102 in additional territories and discussions with potential commercialization partners in the UK and other territories are ongoing."
Additionally, the U.S. Patent and Trademark Office (USPTO) has granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.
About RHB-102 (BEKINDA):
RHB-102 is a proprietary, bimodal release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. RHB-102 24 mg is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the MHRA, RHB-102 24 mg could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of CINV/RINV.
Positive results from two successful late-stage RHB-102 studies at different doses, the U.S. Phase III GUARD gastroenteritis study (RHB-102 24 mg) and the U.S. Phase II IBS-D study (RHB-102 12 mg) were published in JAMA Network Open3 and The American Journal of Gastroenterology4, respectively.
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).
Opaganib was recently selected by the U.S. Government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, 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. 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 has received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. 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.
JOHANNESBURG, April 28, 2023 /PRNewswire/ --(NASDAQ: RDHL) ("RedHill" or the "Company"),
Huh? JOHANNESBURG? Whatever happened to TEL AVIV, Israel and RALEIGH, N.C.?
[Look at the header of today's news]
Whatever happened to the crohns disease drug? They do not even mention it anymore. Honestly all I wanted to do was get back to my 1.00 cost basis so I could sell and we are sitting at .05 cents basically. All they do is put on nonsense PR releases they never have any good news at all.
RedHill Biopharma Announces Q4/22 & Full-Year 2022 Results and Operational Highlights
https://finance.yahoo.com/news/redhill-biopharma-announces-q4-22-110000202.html
Having extinguished all debt and significantly reduced cost-base, RedHill is now focused on late-stage pipeline advancement, in collaboration with U.S. and other governments, commercial growth and revenue-generating product acquisition opportunities
Opaganib selected by NIH's Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS) testing; FDA guidance provided on opaganib Animal Rule regulatory pathway, with Priority Review Voucher potential
Positive UK MHRA scientific advisory meeting for RHB-102 (BEKINDA®) - UK Marketing Authorisation Application (MAA) for oncology support planned; Discussions with potential commercialization partners ongoing
Talicia® delivers year-over-year prescription growth of 57% and first ever warranty program for a widespread community-treated condition1 established
Cash balance of $36.1 million as of December 31, 20222; Reduced operating loss of $9.9 million in Q4/22, compared to $20.7 million in Q4/21; Following the sale of Movantik in exchange for all debt, the consolidated commercial organization will be transitioning to growing Talicia® and Aemcolo® sales and addressing the impact of gross-to-net allowances on revenues
JOHANNESBURG, April 28, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its fourth quarter and full year 2022 financial results and operational highlights.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Having executed on our previously announced agreement with HCR, RedHill is now a debt-free company, with a significantly reduced cost-base, agreed HCR transition services revenues adding to existing revenue streams, and an exciting, U.S. Government supported, late-stage pipeline. We believe that RedHill has emerged from a challenging 2022 as a leaner company, well positioned to focus on potential growth. Our aim is now to maximize the sales of Talicia and Aemcolo, bring in new revenue-generating products and deliver on key late-stage pipeline catalysts. For a second quarter running, RedHill's U.S. commercial operations, including Movantik sales, concluded with balanced cash flows in Q4/22 and continued Talicia's growth curve, delivering year-over-year prescription growth of 57%. Indicative of our confidence in Talicia, and further supporting patient access, we are immensely proud to be the first pharmaceutical company to establish a warranty program for a widespread community-treated (non-hospital) condition, with RedHill committing to reimburse eligible patient out-of-pocket costs should Talicia not work1."
Mr. Ben-Asher continued: "The validation and acceleration of opaganib's potential as a treatment for Acute Radiation Syndrome, following its selection for development by the NIH's RNCP, along with applicability of the FDA Animal Rule regulatory pathway, is exciting. Opaganib has delivered promising efficacy signals, reported in several recently published preclinical studies, has a clinical trial safety database approaching 500 people and has a beneficial product profile, being an easy to administer and distribute oral pill with a five-year shelf-life. This positions opaganib to potentially address an important, high-focus market with an acute unmet medical need. The development of opaganib and RHB-107 for COVID-19 and other indications is also continuing under collaboration with U.S. Government agencies. The inherent value in our late-stage pipeline is further demonstrated by RHB-102's positive UK MHRA pre-MAA scientific advice meeting, opening the door for a potential UK marketing approval submission and the identification of potential commercialization partners."
Financial results for the three months ended December 31, 2022 (Unaudited)3
Net Revenues for the fourth quarter of 2022 were $12.8 million, as compared to $22.1 million for the fourth quarter of 2021. Despite Talicia and Movantik prescription growth, increased gross-to-net allowances reduced net revenues.
Cost of Revenues for the fourth quarter of 2022 was $8.6 million, as compared to $19.3 million for the fourth quarter of 2021. The difference is primarily attributable to a $9 million impairment related to Aemcolo recognized in the fourth quarter of 2021 and in line with the decrease in net revenues.
Gross Profit for the fourth quarter of 2022 was $4.2 million, as compared to $2.7 million for the fourth quarter of 2021. The increase is primarily attributable to the recognized impairment of the Aemcolo intangible asset in the fourth quarter of 2021 as detailed above and partially offset by the decrease in net revenues in the fourth quarter of 2022.
Research and Development Expenses for the fourth quarter of 2022 were $1.1 million, as compared to $5.9 million for the fourth quarter of 2021. The difference is attributable to the ongoing optimization of R&D costs and completion of clinical trials related to COVID.
Selling, Marketing and General and Administrative Expenses for the fourth quarter of 2022 were $13.0 million, as compared to $17.6 million for the fourth quarter of 2021. The difference is mainly attributable to the successful ongoing cost-reduction measures.
Operating Loss for the fourth quarter of 2022 was $9.9 million, as compared to $20.7 million for the fourth quarter of 2021, as detailed above.
Net Cash Used in Operating Activities for the fourth quarter of 2022 was $2.4 million, as compared to $14.9 million for the fourth quarter of 2021. The difference is attributable to the reduction in operating expenses which are due to the ongoing cost-reduction measures.
Net Cash Provided by Financing Activities for the fourth quarter of 2022 was $7.2 million comprised primarily of the public offering in the fourth quarter of 2022.
Cash Balance as of December 31, 2022, was $36.1 million2.
Financial results for the 12 months ended December 31, 20223
Net Revenues for the 12 months ended December 31, 2022, were $61.8 million, as compared to $85.8 million for the 12 months ended December 31, 2021. The reduction is attributable to increased gross-to-net allowances, mainly related to Movantik.
Cost of Revenues for the 12 months ended December 31, 2022, was $33.3 million, as compared to $49.4 million for the 12 months ended December 31, 2021. The decrease is mainly attributable to the implementation of cost reduction measures and goes hand-in-hand with the reduction in revenues and also from the $9 million impairment related to Aemcolo recognized in the fourth quarter of 2021.
Gross Profit for the 12 months ended December 31, 2022, was $28.5 million, as compared to $36.4 million for the 12 months ended December 31, 2021. The decrease mainly resulted from the decrease in revenues, enhanced due to the existence of the $9 million impairment related to Aemcolo recognized as cost of revenues in 2021.
Research and Development Expenses for the 12 months ended December 31, 2022, were $7.3 million, as compared to $29.5 million for the 12 months ended December 31, 2021. The difference is attributable to the ongoing optimization of R&D costs and completion of clinical trials related to COVID.
Selling, Marketing and General and Administrative Expenses for the 12 months ended December 31, 2022, were $64 million, as compared to $88 million for the 12 months ended December 31, 2021. The decrease is mainly attributable to various cost-control measures implemented during the second half of 2022, in particular the reduced salesforce.
Operating Loss for the 12 months ended December 31, 2022, was $42.8 million, as compared to $81.1 million for the 12 months ended December 31, 2021. The difference is primarily attributable to a reduction in operating expenses as detailed above.
Net Cash Used in Operating Activities for the 12 months ended December 31, 2022, was $29.2 million, as compared to $65.0 million for the 12 months ended December 31, 2021. The decrease is in line with the change in Operating Loss and is attributable to the completion of clinical trials related to COVID, as well as to the decrease in Selling, Marketing and General and Administrative Expenses that resulted from our cost reduction measures.
Net Cash Provided by Financing Activities was $11.5 million for the year ended December 31, 2022, comprised primarily of proceeds from equity offerings offset by payments in respect of intangible assets.
Business updates
On April 11, 2023, the Company announced that it received confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5450(a)(1), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on April 5, 2023. Listing compliance follows the Company's implementation of a ratio change of the Company's American Depositary Shares ("ADSs") to its non-traded ordinary shares from the previous ratio of one (1) ADS representing ten (10) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares, which the Company announced on March 16, 2023. The ratio change came into effect on March 23, 2023, and the Company's ADSs continue to be traded on the Nasdaq Global Market ("Nasdaq") under the symbol "RDHL" with a new CUSIP Number 757468202.
On March 30, 2023, the Company announced that it had entered into a definitive agreement for a $6 million registered direct offering, and subsequently announced, on April 3, 2023, the closing of the offering for the purchase and sale of 1,500,000 of the Company's ADSs (or ADS equivalents), series A warrants to purchase up to an aggregate of 1,500,000 ADSs and series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The series A warrants have an exercise price of $4.75 per ADS, are exercisable immediately and have a term of five years following issuance, and the series B warrants have an exercise price of $4.00 per ADS, are exercisable immediately and have a term of nine months following issuance.
On February 6, 2023, the Company announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's U.S. subsidiary RedHill Biopharma Inc. and HealthCare Royalty ("HCR") announced February 25, 2020, as amended, in exchange for the transfer of its rights in Movantik® (naloxegol) to Movantik Acquisition Co., an affiliate of HCR. HCR assumed substantially all post-closing liabilities, and RedHill retained substantially all pre-closing liabilities relating to Movantik. As part of the parties' arrangement, and to ensure continuous patient care, RedHill will provide HCR with transition services for up to 12 months, paid for by HCR. HCR will retain security interests in certain RedHill assets until substantially all pre-closing liabilities relating to Movantik have been paid or other specific conditions are met.
On December 6, 2022, the Company announced the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. Adjusted following the March 23, 2023, ADS ratio change, the offering consisted of 800,000 units/pre-funded units consisting of (a) one ADS (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS at a price to the public of $10.0 per unit (or $9.96 per pre-funded unit after reducing $0.04 attributable to the exercise price of the pre-funded warrants).
Discussions are ongoing for external non-dilutive funding for additional RHB-107 Phase 3 COVID-19 development, the out-licensing of RHB-204 in multiple territories, and the in-licensing of new revenue-generating products.
Commercial Highlights
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)4
26% increase in Talicia prescriptions in Q4/22, compared to Q4/21, 57% year-over-year growth in Talicia prescriptions.
Talicia is the most prescribed branded agent by U.S. gastroenterologists and is on track to become the most prescribed branded H. pylori therapy in the U.S. in 2023.
On March 21, 2023, the Company announced the establishment of a warranty program for its Helicobacter pylori (H. pylori) eradication therapy, Talicia, in which RedHill commits to reimburse patient out of pocket costs should Talicia not work. 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 testing1. It is believed that this is the first time a warranty program has been offered for a widespread community (non-hospital) treated condition, lowering the bar for patient access.
New Talicia data analyses were presented at Obesity Week (November 2022) and the World Gastro 2022 congress (August 2022) supporting the efficacy and safety of Talicia as empiric first-line treatment for H. pylori infection in patients regardless of obesity, body mass index (BMI) or diabetic status.
Total Talicia coverage stood at more than 202 million American lives as of December 31, 2022.
Aemcolo® (rifamycin)5
On December 5, 2022, the Company announced that the FDA Exclusivity Board has granted Aemcolo five years' exclusivity under the FDA's Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data exclusivity, extending regulatory exclusivity through to 2028.
Movantik® (naloxegol)6
Movantik stopped being a RedHill product on February 6, 2023, with ownership transitioned to Movantik Acquisition Co., an affiliate of HCR, in exchange for extinguishment of all RedHill's debt obligations with HCR. Revenues for Movantik were recorded up to and including February 1, 2023.
As part of the agreement, and to ensure continuous patient care, RedHill will provide HCR with transition services for up to 12 months, paid for by HCR.
R&D Highlights
Opaganib (ABC294640)7 - A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory indications, oncology and radioprotection.
Nuclear Medical Countermeasures (Acute Radiation Syndrome):
On November 14, 2022, the Company announced acceleration of opaganib's nuclear radiation protection development program, with newly published data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
On February 15, 2023, the Company 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, utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher.
On February 28, 2023, the Company further 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 opaganib 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.
Additional collaboration discussions with U.S. and other governments are ongoing.
COVID-19, pandemic preparedness and other:
Demonstrated preliminary evidence of in vitro inhibition of Omicron BA.5 sub-variant (October 2022).
Opaganib granted a new United States Patent and Trademark Office (USPTO) patent for the treatment of COVID-19 (October 2022).
New in vivo data demonstrating opaganib's potential to protect against renal damage in acute kidney injury (AKI) published in the International Journal of Nephrology and Renovascular Disease (November 2022).
Ongoing preclinical development of opaganib in collaboration with the US Army and NIAID for various anti-viral indications.
RHB-107 (upamostat)8 – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
Demonstrated preliminary in vitro inhibition of Omicron BA.5 sub-variant in testing conducted by the University of Tennessee in October 2022.
Discussions ongoing for external non-dilutive funding for additional Phase 3 COVID-19 development.
RHB-107 is also the subject of several cooperative projects, being arranged with government and non-government bodies, on a range of preclinical studies against multiple viral targets, including influenza and Ebola (amongst others).
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease9 (NTM)
On January 26, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) had issued a Notice of Allowance for the granting of a patent covering RHB-204's oral fixed-dose combination, methods for treating pulmonary Mycobacterium avium Complex (MAC) disease, and kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease. Once issued, the patent is expected to protect RHB-204 through 2041.
In August 2022, the European Commission granted Orphan Drug Designation to RHB-204, which is in an ongoing U.S. Phase 3 study, for the treatment of nontuberculous mycobacteria (NTM) disease, providing 10 years of post-approval EU market exclusivity.
RHB-102 (BEKINDA) – Oncology Support
On February 16, 2023, the Company announced that following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) in adults and children over the age of 12.
Discussions for potential commercialization partners are ongoing.
RedHill Biopharma Granted US Patent for Cancer Treatment Combination
https://beststocks.com/redhill-biopharma-granted-us-patent-for-cance/
Yasmim Mendonça
On April 25, 2023, RedHill Biopharma announced that they have been granted a US patent for their combination compositions for the treatment of cancer. The patent, numbered #11633385, covers using Yeliva, a sphingosine kinase-2 (SK2) inhibitor, and doxorubicin, a chemotherapy drug, for treating cancer. Preclinical studies have shown promising results combining these two drugs, demonstrating synergistic anti-tumor activity.
RedHill Biopharma is a specialty biopharmaceutical company focusing on gastrointestinal and infectious diseases. The company has been at the forefront of global efforts to combat COVID-19, developing two novel Phase 2/3-stage oral therapies that cover the spectrum of disease severity with the expected effect against emerging variants.
In addition to the newly granted patent for cancer treatment, RedHill has also received a Notice of Allowance for a patent covering the use of RHB-204, specific fixed-dose combination therapy for the treatment of NTM disease. The company is currently in discussions with several prospective partners for RHB-204 across multiple territories.
RedHill Biopharma (RDHL):
Last closing price $3.10.
Current price $3.36.
Increase: +8.39%.
See more information on TipRanks RDHL page
---------------------------------------------------
The start of a reversal?
(Finally???)
Sure hope so.
RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement
https://finance.yahoo.com/news/redhill-biopharma-regains-compliance-nasdaq-110000943.html
TEL AVIV, Israel & RALEIGH, N.C., April 11, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from The Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1) for continued Nasdaq listing, and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5450(a)(1), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on April 5, 2023.
As previously announced, on October 12, 2022, the Company reported that it had received notification that, for the previous thirty consecutive business days, the bid price for the American Depositary Shares (the "ADSs") had closed below the minimum $1.00 per share requirement for continued listing. On April 6, 2023, the Company received notification from the Nasdaq Listings Qualifications Department that the ADSs had, for the last 10 consecutive business days, a closing bid price at $1.00 per share or greater, and accordingly had regained compliance with Nasdaq Listing Rule 5450(a)(1).
Apparently there is no
bottom for RDHL.
RedHill Biopharma Announces Closing of $6 Million Registered Direct Offering
https://finance.yahoo.com/news/redhill-biopharma-announces-closing-6-172600473.html
TEL AVIV, Israel and RALEIGH, N.C., April 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has closed its previously announced registered direct offering for the purchase and sale of 1,500,000 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, series A warrants to purchase up to an aggregate of 1,500,000 ADSs and series B warrants to purchase up to an aggregate of 1,500,000 ADSs. The series A warrants have an exercise price of $4.75 per ADS, are exercisable immediately and have a term of five years following issuance, and the series B warrants have an exercise price of $4.00 per ADS, are exercisable immediately and have a term of nine months following issuance.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
The gross proceeds to the Company from this offering were $6 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general working capital, acquisitions, research and development, and general corporate purposes.
..."I still hang on, not expecting a miracle,
rather awaiting some big gains to offset
my (quite substantial) RDHL loss."
My feelings exactly! I just want to exit RDHL with some dignity.
By "dignity" I mean break even, using a profitable stock to offset this loss.
Have a good day my friend!
Of course since i invest in bios
i had my share of losses, eg
BVXV which failed in phase III.
That is unfortunate but it happens.
In RDHLs case the failure is in pure
management incompetence and malfunction.
I still hang on, not expecting a miracle,
rather awaiting some big gains to offset
my (quite substantial) RDHL loss.
In my many years in stock investing, i
have never had a worse performing.
stock in the likes of RDHL.
Two offerings now in 4 months and nobody knows where the money goes. They have 36 million in cash yet they keep doing offerenings. Something is just not adding up at all.
Offering after offering with no idea where the mone goes at all. Worthless press releases and stugg they claim is in phase 3 but we never hear a work about. I am beginning to think the company is just one big giant ponzi scheme
RedHill Biopharma Announces $6 Million Registered Direct Offering
TEL AVIV, ISRAEL & RALEIGH, N.C., March 30, 2023 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement for the purchase and sale of 1,500,000 of the Company’s American Depositary Shares (“ADSs”) (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, series A warrants to purchase up to an aggregate of 1,500,000 ADSs and series B warrants to purchase up to an aggregate of 1,500,000 ADSs at a purchase price of $4.00 per ADS (or ADS equivalent) and associated warrants, in a registered direct offering. The series A warrants have an exercise price of $4.75 per ADS, are exercisable immediately and have a term of five years following issuance, and the series B warrants have an exercise price of $4.00 per ADS, are exercisable immediately and have a term of nine months following issuance. The closing of the offering is expected to occur on or about April 3, 2023, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The gross proceeds to the Company from this offering are expected to be $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general working capital, acquisitions, research and development, and general corporate purposes.
Unless RDHL announces some source
of revenue, the stock will tank to the
previous 13cents level soon enough.
Very sad!
Tomorrow's , 1 for 40 reverse split is keeping this in check ,imo.
But should open close to $6 ..in the morning. THEN ??????
$RDHL...
.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,
0.1449+0.0048 (+3.43%)
As of 03:12PM EDT. Market open.
This is more like it, but todays news
deserves a bigger sp appreciation.
I was expecting a much more enthusiatic
reaction towards todays news.
Oh well.
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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)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
972 3 541 3131
http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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02-07-2021
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