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Another example:
GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html
The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax's vaccine.
Complete garbage. Other than hoping for a miracle there is nothing here at all. This company is a complete joke.
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RedHill Biopharma Ltd. (RDHL)
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0.3953
-0.0149
(-3.63%)
the ship has been sinking for over two years so i doubt it. Just probably got tired of the company going nowhere.
no suprise just computers and day traders let it run up 5 or 6 cents than short it down. When there is never any real news not hard to do. Nobody cares about the stupid patents.
RedHill Biopharma Ltd. (RDHL)
0.4220 -0.0380 (-8.26%)
As of 9:45 AM EDT. Market Open.
Timberrrrrrrrrrrrrrrrr!
Real news:
6K
Redhill Biopharma Ltd. (the “Company”) announced that on June 4, 2024 Ms. Alla Felder submitted to the board of directors (the “Board”) a notice of resignation from her position as a member of the Board, effective June 6, 2024. Ms. Felder’s resignation from the Board is due to personal reasons and not as a result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Mr. Dror Ben-Asher, Chairman of the Board, commented, “On behalf of the entire Board, I thank Alla for the valuable contributions she has provided to the Company as a Board member.”
----------------------------------------------------------------------------------------------------------------
Rats leaving the sinking ship, i wonder?
down today though. Need real news.
Momentum continues,
i wonder why?
0.4700 +0.0225 (+5.0279%)
As of 2:08 PM EDT. Market Open.
Rise and Shine.
What a complete waste of time and money . They must have more patents than even company I have ever seen but with no approved drug they are totally worthless.
RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040
https://finance.yahoo.com/news/redhill-announces-patent-covering-opaganib-110000734.html
New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response[1]. Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications[2] through 2040
ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)[3]
Opaganib, a host-directed and potentially broad acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, is in development for multiple oncology, viral and inflammatory indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure
TEL-AVIV, Israel and RALEIGH, N.C., June 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent notice of allowance for opaganib[4] in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response, providing protection for opaganib's potential use with a range of approved and in-development immune checkpoint inhibitors (ICIs) across a growing range of indications through 2040. The patent will be issued by the Chinese National Intellectual Property Administration (CNIPA) (Chinese Patent Application No.: 202080013805.3 issued May 24, 2024).
"ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab)," said Guy Goldberg, RedHill's Chief Business Officer. "This exciting new patent is based on compelling data from a range of in vivo experiments showing significant improvements in outcomes in combination with selected ICIs. China has been a world leader in embracing ICI-based therapy[5] and this is an important addition to the strong patent portfolio protecting opaganib."
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib's host-directed action 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 has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation Syndrome (ARS); and the Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by the Administration for Strategic Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) and NIH/NIAID selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure.
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
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. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.
Opaganib has received Orphan Drug designation from the 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 FDA-IND submission.
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 adults[6], and Aemcolo®, for the treatment of travelers' diarrhea in adults[7]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with U.S. government collaborations for development for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential 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; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.
They are the kings of patents for drugs that are not approved. It will not move it they must have hundreds of patents now but they dont mean a thing without an approved drug.
Will this news move the needle north?
I doubt it, patents are only $ worth if
commercial use is made, eg some
BP buys it.
RedHill Announces New Opaganib Chinese Patent Against Ebola Virus Valid Through 2035
https://finance.yahoo.com/news/redhill-announces-opaganib-chinese-patent-110000975.html
The new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) is valid through 2035 and adds to opaganib's strong global intellectual property portfolio across multiple indications
--
U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
--
A host-directed and potentially broad acting twice-daily oral, small molecule, opaganib is in development for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure. It has a demonstrated safety and efficacy profile, and is well-suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute
TEL-AVIV, Israel and RALEIGH, N.C., May 6, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent Notice of Allowance covering opaganib[1] as a therapyg for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus) from the Chinese National Intellectual Property Administration (CNIPA), valid through 2035 (Chinese Patent Application No.: 202110229970.9 issued April 29, 2024).
"This new patent adds to the existing intellectual property portfolio protecting opaganib across multiple indications and represents the first China patent in the Ebola patent family," said Guy Goldberg, RedHill's Chief Business Officer. "U.S. Army studies suggest that opaganib may be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival. Targeting multiple indications, including selection by two U.S. government countermeasures programs for Acute Radiation Syndrome and Sulfur Mustard exposure, oral opaganib, has a demonstrated safety and efficacy profile and is well-suited to viral pandemic scenarios, being viral mutation-resistant, and easy to administer and distribute."
About Ebola virus disease:
According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™ (atoltivimab/maftivimab/odesivimab, Regeneron Pharmaceuticals, Inc), a combination of three monoclonal antibodies and Ebanga™ (ansuvimab-zykl, Ridgeback Biotherapeutics, LP), a single monoclonal antibody. Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.
Yep, you wrapped it up nicely.
Still, i am somehow hopeful, but
for sure will not add to what i already own.
And that is where the problem lies with the paragraph you copied. They have copied and pasted now for well over a year with nothing happening. At this point it is kind of hard to believe them honestly. In theory something could happen and the stock go be a 15 bagger overnight. However, they so far have proven not to be able to deliver on anything except cutting costs. All the people they got the money from in offerings were also told something and it has not happened. The amount of people will to give them money anymore is going to dry up fast.
Tempting to buy more at this price but what are they going to do for money is my biggest concern. The sales from talicia cannot fund operations they are far too small and they cannot continut doing offerings anymore I doubt anyone will give them money.
Something similar i would hope for:
Not the news i would have expected,
but at least the study is
RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study
https://finance.yahoo.com/news/redhill-announces-first-patient-enrolled-110000993.html
First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat)1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense
The study is expected to be completed by the end of 2024
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19 in a U.S. Phase 2 study2
RHB-107 is a novel, oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations3
RALEIGH, N.C. and TEL-AVIV, Israel, April 24, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient has been enrolled in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 (upamostat) is the first drug being tested in this platform study. Funded through non-dilutive external sources, including the U.S. Department of Defense, the PROTECT study is expected to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by the end of 2024.
"Enrollment of the first patient in the study marks an important milestone for RHB-107 in the 300-patient U.S. government-supported PROTECT platform study, which could add significant validating data to the previous marked reduction in hospitalizations due to COVID-19 seen in the RHB-107 arm of our earlier U.S. Phase 2 study," said Gilead Raday, RedHill's Chief Operating Officer and Head of R&D. "RHB-107 is a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations. If approved, RHB-107 could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Paxlovid. Additionally, with both RHB-107 and opaganib recently demonstrating distinct synergistic effect when combined individually with remdesivir in an in vitro Ebola study, we are making encouraging progress with our pipeline assets for pandemic preparedness."
Data from RHB-107's previous U.S. Phase 2 study showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat compared to 8 days with the placebo.
The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The study will compare investigational products (IPs) to control, in standard-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the initial drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms. Participants will be followed for a period of up to 12 weeks.
Selection of IPs for inclusion in the ACESO PROTECT study is based on review of the preclinical and early clinical data, evaluating safety, tolerability, and efficacy. Selection is also based on route of administration and product availability.
RHB-107's development for COVID-19 runs parallel to the development of opaganib, RedHill's other novel oral drug, for Acute Radiation Syndrome, being done in collaboration with, and funded by, the U.S. government's National Institutes of Health Radiation and Nuclear Countermeasures Program. Both RHB-107 and opaganib also recently demonstrated distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash).
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[4].
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma AG (FSE: HPHA) (formerly WILEX AG) for all indications.
About HJF
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), now celebrating its 40th anniversary, is a global nonprofit organization with the mission to advance military medicine. HJF's scientific, administrative and program operations services empower investigators, clinicians, and medical researchers around the world to make discoveries in all areas of medicine. HJF serves as a trusted and responsive link between the military medical community, federal and private partners, and the millions of warfighters, veterans, and civilians who benefit from military medicine. For more information, visit www.hjf.org.
About ACESO
The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) aims to improve survival for patients with sepsis in resource-limited settings through development of host-based technology solutions and evidence-based clinical management strategies. Founded in 2010, ACESO brings together a consortium comprised of academic, non-profit, governmental, and industry partners that is administered by HJF. ACESO has established a global clinical research network to develop and deliver cutting-edge tools and strategies to save lives in austere settings.
For more information, visit www.aceso-sepsis.org.
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[5], and Aemcolo®, for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential 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; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.
I certainly hope so they just need to go 1/3 to get one. They need something the current revenue from talicia is not enough to avoid future offerings.
One day RDHL will land a substantial
$ amount by BARDA, NIH and/or US
military for a stockpiling contract(s).
This will mark a turning point for RDHL.
My very humble opinion.
Why you think we will one day be rewarded?
"That's the spirit!" Keep your chin up! Look what's going on around you; you don't need to worry about RDHL. It's only money!
One day we shall be pleasantly surprised
and handsomely rewarded.
IMO.
I wonder how they plan to do the next offering at these low levels. They would drive the stock down to .10 cnets if they do. They have themselves in a real pickle. THey only have one good option and that is to sell but I doubt they are smart enough to do that.
Just when you think it cannot get any worse it does. Hedge funds totally control the price. The company would be best served to be aquired they are not going to be able to survive on their own. It willl just continue to be dilution after dilution and reverse splits to stay in compliance. It is not sustainable.
worse and worse each day. 52 week lows incoming.
worse and worse each day. 52 week lows incoming.
No drip drip, free fall.
Drip drip drip drip. Boy those earnings did wonders for the stock.
Sadly the market does now care we just drip lower and lower.
RedHill Biopharma Full Year 2023 Earnings: EPS: US$4.00 (vs US$46.29 loss in FY 2022)
https://finance.yahoo.com/news/redhill-biopharma-full-2023-earnings-102334385.html
editorial-team@simplywallst.com (Simply Wall St)
Wed, April 10, 2024 at 1:23 PM GMT+3
RedHill Biopharma (NASDAQ:RDHL) Full Year 2023 Results
Key Financial Results
Net income: US$23.9m (up from US$71.7m loss in FY 2022).
EPS: US$4.00 (up from US$46.29 loss in FY 2022).
earnings-and-revenue-history
earnings-and-revenue-history
All figures shown in the chart above are for the trailing 12 month (TTM) period
RedHill Biopharma shares are down 6.0% from a week ago.
Risk Analysis
We should say that we've discovered 3 warning signs for RedHill Biopharma (1 doesn't sit too well with us!) that you should be aware of before investing here.
The market does not care only massive big news is going to move this thing. If they continue to do more offerings the stock is doomed for good. He always blabs arout partners when he speaks but thy never get any partners. I feel like they are happy to do offerings til the end of time as they clearly do not care about the stock price. We also may be getting to a point where nobody will give them money anymore so the offerings might not happen due to that.
Truth is i had expected a much warmer
enthusiastic market reception to the news!
IMO the only way in the future to raise
cash is by receiving a stockpiling contract
by BARDA/US military etc.
They were certainly not bad but that talicia revenue is still nowhere where it needs to be to keep them from doing more offerings. They cannot continue these nonsense offerings they have to find another way to get money.
A lot better results than i had anticipated.
RedHill Biopharma Announces Full-Year 2023 Results and Operational Highlights
https://finance.yahoo.com/news/redhill-biopharma-announces-full-2023-130000273.html
RedHill continues corporate transformation to focus on U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base
Focused externally funded R&D:
Opaganib for nuclear and chemical medical countermeasure (NIH funding): Selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. Nuclear and chemical incident response strategies are characterized by significant government stockpiling of approved agents
Opaganib for Ebola (U.S. Army funding): U.S. Army studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
RHB-107 for COVID-19 (U.S. DoD funding): Selected for inclusion in the 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment; COVID-19 treatment continues to be a multi-hundreds of million-dollar market
RHB-107 for Ebola (U.S. Army funding): RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies
With multiple target indications, opaganib and RHB-107 are novel, oral, host-directed small molecule drugs in advanced clinical development, with demonstrated safety & efficacy profiles, well suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute
Discussions ongoing with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or commercial operations
Cash balance of $6.5 million as of December 31, 20231; Gross profit of $3.1 million on revenues of $6.5 million and an operating income of $12.6 million during the year ended December 31, 2023, versus operating loss of $42.8 million during the year ended December 31, 2022
TEL AVIV, Israel and RALEIGH, N.C., April 8, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full year 2023 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2023.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The RedHill of today is transformed - focused on predominantly U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base and unburdened by debt - we have a very clear direction and value proposition. We are actively pursuing and in discussions with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or our commercial operations, while we focus on the progression of our two lead R&D candidates, opaganib and RHB-107. Both are advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both an aggregated multi-billion global market opportunities and potentially advantageous pathways to approval under the FDA Animal Rule2 for certain indications."
Mr. Ben-Asher continued: "We believe that growing geo-political instability and current regional conflicts are causes for concern regarding increased potential for both nuclear and chemical threats. Governments across the world and global health organizations have been stepping up their efforts to find new options in the face of these devastating possibilities – especially those that can be delivered in challenging circumstances. Opaganib has now been selected by separate U.S. government-funded programs for evaluation as a nuclear and chemical medical countermeasure for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. RHB-107 has been selected for inclusion in the predominantly U.S. Department of Defense (DoD)-funded 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, for which screening has commenced and first patients are expected to be enrolled imminently. In addition, in U.S. Army studies, both opaganib and RHB-107 have delivered positive results in pre-clinical testing against Ebola – a disease with a more than 50% mortality rate for which innovation in therapy is desperately needed. Opaganib, we believe, became the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival, while both opaganib and RHB-107 showed an in vitro synergistic effect with remdesivir in viral inhibition. Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs, with demonstrated safety and efficacy profiles, that are well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, being mutation-resistant and easy to administer and distribute."
Financial results for the 12 months ended December 31, 20233
Net Revenues for the year ended December 31, 2023, were $6.5 million, compared to $61.8 million for the year ended December 31, 2022. The decrease was primarily attributable to the divestiture of Movantik. Talicia net revenues for the year ended December 31, 2023, increased to $8.8 million from $7.7 million for the year ended December 31, 2022, driven mainly by a 15% increase in gross revenues, with stable Gross-to-Net. Net revenues for the year ended December 31, 2023, were reduced by ($2.6) million in contra-revenues for Movantik, largely from returns.
Cost of Revenues for the year ended December 31, 2023, was $3.5 million, compared to $33.3 million for the year ended December 31, 2022. This decrease was primarily attributable to the divestiture of Movantik. As a result of this divestiture, both the recognition of revenues 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 year ended December 31, 2023, was $3.1 million, compared to $28.5 million for the year ended December 31, 2022, in line with the decrease in Net Revenues and Cost of Revenues as explained above and primarily attributable to the divestiture of Movantik.
Research and Development Expenses for the year ended December 31, 2023, were $3.5 million, as compared to $7.3 million for the year ended December 31, 2022. The difference is attributable to the completion of clinical trials related to COVID-19 and RHB-107, and to ongoing cost-reduction measures.
Selling, Marketing and General and Administrative Expenses for the year ended December 31, 2023, were $31.0 million, as compared to $64.0 million for the year ended December 31, 2022. The difference was primarily attributable to the ongoing cost-reduction measures and to the divesture of Movantik as described above.
Other Income for the year ended December 31, 2023, was $44.1 million, as compared to no other income recognized for the year ended December 31, 2022. The other income was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services fees provided to the buyer of Movantik.
Operating Income for the year ended December 31, 2023, was $12.6 million, compared to operating loss of $42.8 million for the year ended December 31, 2022. The difference is primarily attributable to the changes resulting from the divestiture of Movantik, as detailed above.
Financial Income, net for the year ended December 31, 2023, was $11.3 million, compared to Financial Expenses, net of $28.8 million for the year ended December 31, 2022. The income recognized in the year ended December 31, 2023, was primarily attributable to a $20.6 million 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, partially offset by financial expenses related to the derivative financial instruments and other financial expenses.
Net Income of $23.9 million for the year ended December 31, 2023, as compared to Net Loss of $71.7 million for the year ended December 31, 2022, primarily attributed to the changes resulting from the sale of Movantik and to the ongoing cost-reduction measures, as detailed above.
Total Assets as of December 31, 2023, were $23 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 (attributed to the fact that the receivables as of December 31, 2022, were primarily associated with Movantik).
Total Liabilities as of December 31, 2023, were $21 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. Remaining pre-closing liabilities related to Movantik as of December 2023, are estimated at $4.8 million.
Net Cash Used in Operating Activities for the year ended December 31, 2023, was $35.8 million, compared to $29.2 million for the year ended December 31, 2022. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities.
Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of the net proceeds from offerings and exercise of warrants in the year ended December 31, 2023, and the decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchase.
Cash Balance as of December 31, 2023, was $6.5 million1.
R&D Overview
RedHill's R&D efforts are concentrated on its two lead investigational candidates, opaganib and RHB-107 – with both advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both sizeable market opportunities, estimated aggregate to be well in excess of $1 billion globally, and potentially advantageous pathways to approval.
Opaganib's development is focused on a potential role as a nuclear and chemical medical countermeasure in the event of radiation and chemical incidents, while RHB-107 remains focused on the outpatient treatment of COVID-19. Both molecules have also shown promise for potential use in the treatment of the Ebola virus disease, along with other viral pandemic scenarios, and various inflammatory and oncologic conditions.
Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles that are ideally suited to nuclear/chemical incidents and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute.
Opaganib (ABC294640)4
Opaganib is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with potential for broad activity across radioprotection, cancer, inflammatory and viral conditions. Opaganib's host-directed action 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). Current focuses of opaganib's development are:
Nuclear and chemical medical countermeasures: Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH.
Ebola virus disease: U.S. Army-funded and conducted studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, significantly increasing survival time, and separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability.
Nuclear and Chemical Medical Countermeasures updates
In November 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:
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.
Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
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.
Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
In addition, in November 2022, the Company announced additional positive in vivo results from a new pre-clinical study evaluating the effects of opaganib on radiation-induced hematologic and renal toxicity, which suggests that opaganib exerts a protective impact on key hematological and kidney function parameters following total body irradiation (TBI). Development of opaganib as a homeland security nuclear medical countermeasure is currently expected to follow the Animal Rule under which human efficacy studies may not be required, and if approved, may be eligible for a Medical Countermeasure Priority Review Voucher.
In February 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, had selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for ARS. As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with us, to test opaganib in established ARS models.
In July 2023, the Company announced that Apogee had been awarded a further $1.7 million in U.S. government funding, via a Small Business Innovation Research (SBIR) grant, which will support research to further the development of opaganib as an MCM for GI-ARS. This grant is in addition and complementary to the multimillion dollar-valued U.S. government RNCP product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development.
In February 2024, the Company announced that the International Journal of Molecular Sciences published data showing that opaganib protects against radiation-induced lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation.
In March 2024, the Company announced that opaganib had been selected by the U.S. government's Chemical Medical Countermeasure Program and chemical countermeasures research program for evaluation as a potential MCM against inhalation Sulfur Mustard exposure. This selection follows opaganib's previous acceptance into the RNCP for ARS development, providing the potential to see broad activity across both radiation and Sulfur Mustard injuries.
Ebola updates
In October 2023, the Company announced that opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) with a 30% mice survival benefit compared to control in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.
In December 2023, the Company announced that opaganib demonstrated a robust synergistic effect when combined with remdesivir (Veklury® by Gilead Sciences, Inc.), significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.
RHB-107 (upamostat)5
A novel investigational broad-acting, host-directed once-daily oral antiviral targeting multiple potential indications with a focus on COVID-19 and other viruses as part of a pandemic preparedness approach. RHB-107 targets human serine proteases involved in preparing the spike protein for viral entry into target cells and inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated demonstrating its clinical safety profile in approximately 200 patients6. Current focus for RHB-107 development is:
COVID-19 outpatient treatment: Accepted for inclusion in the U.S. DoD-supported 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, with first patient expected to be enrolled imminently
Ebola virus disease: In U.S. Army-funded and conducted studies RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir
COVID-19 updates:
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.
In July 2023, the Company announced that RHB-107 had been accepted for inclusion in the U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment. The 300-patient Phase 2 study has received FDA clearance. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024. The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).
In December 2023, the Company announced the receipt of non-dilutive external funding, additional to the previously announced U.S. Government funding, which now covers the entirety of the RHB-107 (upamostat) arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment.
Ebola Virus Disease updates:
As part of a collaboration with the Therapeutic Discovery Branch of the USAMRIID (US Army Medical Research Institute of Infectious Diseases) in-vitro studies against different strains of Ebola virus and additional viral infectious diseases were undertaken. Initial data from high-content imaging assays provided further support for activities of RedHill candidates against these viral diseases.
In December 2023, the Company announced results from a U.S. Army-funded and conducted Ebola virus in vitro study. RHB-107 demonstrated robust synergistic effect when combined with remdesivir (Veklury® by Gilead Sciences, Inc.), significantly improving viral inhibition while maintaining cell viability.
Other R&D updates:
RHB-204: On January 26, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for the granting of a patent covering orphan drug designated 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, expected to protect RHB-2047 through 2041.
RHB-102: 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.
RHB-204 and RHB-102 are subject to ongoing commercialization / out-licensing / divestment discussions.
Talicia 2023 Updates
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)8
Talicia continues to be the most prescribed branded agent for H. pylori eradication by U.S. gastroenterologists9.
Total Talicia coverage stood at nearly 200 million American lives as of December 31, 202310.
On August 1, 2023, the Company announced that Gaelan Medical had received marketing approval for Talicia in the UAE and that Gaelan Medical has subsequently placed the first commercial order for Talicia, which was dispatched from the CMO in December 2023.
In September 2023, the Company announced that the FDA approved our Supplemental new drug application (sNDA) for Talicia®, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, enabling patients to follow a convenient "breakfast, lunch and dinner" dosing routine, which may support increased patient adherence and optimize he potential for successful H. pylori eradication.
In November 2023, Talicia® was granted another five years' market exclusivity under the QIDP designation by the FDA under the GAIN Act. This grant is on top of the three years' exclusivity granted for the approval of Talicia® under section 505(b)(2). Talicia® is protected by its broad intellectual property suite to 2034.
In January 2024, the Company announced that the USPTO issued a new patent covering Talicia® as a method for eradicating H. pylori regardless of BMI. The new patent is expected to provide protection for Talicia® until May 2042.
In March 2024, the Company announced that Talicia had received a new U.S. patent covering its use as an all-in-one treatment of H. pylori infection, providing protection until 2034.
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 adults11, and Aemcolo®, for the treatment of travelers' diarrhea in adults12. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential 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; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. 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 potential divestment of certain of our assets and/or commercial operations, progress of the R&D activities for opaganib and RHB-107, including timing of opaganib's development for Acute Radiation Syndrome and the potential market opportunity for opaganib and RHB-107. 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, market and other conditions, the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the risk that the potential divestment of certain of our assets and/or commercial operations will not occur or will be delayed, the risk of delay in the R&D activities for opaganib or RHB-107, including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment, the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; 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; that the RHB-107 Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment 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 April 8, 2024. 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 Including cash, cash equivalents, short-term bank deposits and restricted cash.
2 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.
3 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
4 Opaganib is an investigational new drug, not available for commercial distribution.
5 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
6 https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
7 RHB-204 is an investigational new drug, not available for commercial distribution.
8 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.
9 IQVIA XPO Data on file.
10 © 1998 - 2024 Managed Markets Insight & Technology, LLC. All rights reserved.
11 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.
12 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.
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Year Ended December 31,
2023
2022
2021
U.S. dollars in thousands
NET REVENUES
6,530
61,800
85,757
COST OF REVENUES
3,459
33,337
49,406
GROSS PROFIT
3,071
28,463
36,351
RESEARCH AND DEVELOPMENT EXPENSES
3,528
7,279
29,498
SELLING AND MARKETING EXPENSES
14,756
35,442
55,623
GENERAL AND ADMINISTRATIVE EXPENSES
16,219
28,586
32,365
OTHER INCOME
44,064
—
—
OPERATING INCOME (LOSS)
12,632
(42,844)
(81,135)
FINANCIAL INCOME
20,889
13,562
51
FINANCIAL EXPENSES
9,605
42,387
16,660
FINANCIAL INCOME (EXPENSES), net
11,284
(28,825)
(16,609)
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE
PERIOD
23,916
(71,669)
(97,744)
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars)
0.01
(0.12)
(0.21)
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
December 31,
December 31,
2023
2022
U.S. dollars in thousands
CURRENT ASSETS:
Cash and cash equivalents
5,569
19,968
Bank deposits
—
15
Restricted cash
790
16,000
Trade receivables
2,591
34,521
Prepaid expenses and other receivables
2,801
4,387
Inventory
4,389
11,009
16,140
85,900
NON-CURRENT ASSETS:
Restricted cash
147
150
Fixed assets
193
502
Right-of-use assets
989
6,692
Intangible assets
5,578
65,626
6,907
72,970
TOTAL ASSETS
23,047
158,870
CURRENT LIABILITIES:
Account payable
3,278
4,230
Lease liabilities
718
1,032
Allowance for deductions from revenue
10,654
47,870
Accrued expenses and other current liabilities
4,592
17,949
Borrowing
—
115,216
Payable in respect of intangible assets purchase
—
11,157
19,242
197,454
NON-CURRENT LIABILITIES:
Lease liabilities
455
6,443
Derivative financial instruments
741
2,623
Royalty obligation
540
750
1,736
9,816
TOTAL LIABILITIES
20,978
207,270
EQUITY (CAPITAL DEFICIENCY):
Ordinary shares
21,441
2,835
Additional paid-in capital
388,363
382,625
Accumulated deficit
(407,735)
(433,860)
TOTAL EQUITY (CAPITAL DEFICIENCY)
2,069
(48,400)
TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY)
23,047
158,870
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
2023
2022
2021
U.S. dollars in thousands
OPERATING ACTIVITIES:
Comprehensive income (loss)
23,916
(71,669)
(97,744)
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers
1,647
5,675
10,212
Depreciation
1,445
2,136
1,914
Amortization of intangible assets
545
6,018
16,235
Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, (see
below)
(56,082)
—
—
Gains from early termination of leases and impairment of fixed assets, net
(543)
—
—
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase
—
33,151
5,366
Fair value (gains) losses on derivative financial instruments and changes in royalty obligation
5,359
(13,422)
5
Loss from modification of warrants terms as part of a new issuance
1,459
—
—
Issuance costs in respect of warrants
2,034
958
—
Exchange differences and revaluation of bank deposits
19
(40)
118
(44,117)
34,476
33,850
Changes in assets and liability items:
Decrease (increase) in trade receivables
31,930
(2,845)
(3,021)
Decrease in prepaid expenses and other receivables
1,586
274
860
Decrease (increase) in inventories
2,387
3,801
(8,285)
Increase (decrease) in accounts payable
(952)
(7,434)
111
(Decrease) in accrued expenses and other liabilities
(13,354)
(2,947)
(3,186)
Increase (decrease) in allowance for deductions from revenue
(37,216)
17,159
12,368
(15,619)
8,008
(1,153)
Net cash used in operating activities
(35,820)
(29,185)
(65,047)
INVESTING ACTIVITIES:
Purchase of fixed assets
(11)
(198)
(115)
Change in investment in current bank deposits
15
8,500
(8,500)
Proceeds from sale of financial assets at fair value through profit or loss
—
—
475
Net cash provided by (used in) investing activities
4
8,302
(8,140)
FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares and warrants, net of issuance costs
13,959
23,806
78,536
Exercise of options into ordinary shares
—
—
4,006
Repayment of payable in respect of intangible asset purchase
(6,555)
(10,878)
(7,397)
Decrease in restricted cash
15,210
—
—
Payment of principal with respect to lease liabilities
(1,175)
(1,475)
(1,683)
Net cash provided by financing activities
21,439
11,453
73,462
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
(14,377)
(9,430)
275
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
(22)
(76)
(96)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
19,968
29,474
29,295
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
5,569
19,968
29,474
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
138
84
47
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
367
8,182
11,280
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING
ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities
270
5,590
303
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $4,697
in 2023 and $534 in 2022) resulting from early termination of lease.
5,413
587
—
Transfer of rights in Movantik® and extinguishment of debt obligations:
Decrease in Intangible asset
(59,503)
Decrease in Inventories
(4,233)
Decrease in Payable in respect of Intangible asset
4,602
Decrease in Borrowing
115,216
Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations
56,082
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SOURCE RedHill Biopharma Ltd.
I hole out almost zero hope they will be good. About the only thing we can expect in the future is more offerings.
RedHill Biopharma Announces $1.25 Million Registered Direct Offering at a Premium to Market Price
https://finance.yahoo.com/news/redhill-biopharma-announces-1-25-110000118.html
TEL AVIV, Israel and RALEIGH, N.C., April 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into definitive agreements with private investors for the purchase and sale, at a premium, of 2,144,487 of the Company's American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares, par value NIS 0.01 per share, of the Company, and warrants to purchase up to an aggregate of 2,144,487ADSs, at a purchase price of $0.58289 per ADS and accompanying warrant, in a registered direct offering. The price per ADS and accompanying warrant represents a premium of 10% over $0.5299, the closing price of the ADSs as reported by the Nasdaq Capital Market on March 28, 2024. The warrants will have an exercise price of $0.75 per ADS, will be immediately exercisable upon issuance and have a term of five years following the issuance date. The closing of the offering is expected to occur on or about April 3, 2024, subject to the satisfaction of customary closing conditions.
No placement agent was used in connection with the offering.
The gross proceeds to the Company from the offering are expected to be $1.25 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes and working capital. The Company also announces that it plans to file its 2023 20-F on or about April 8, 2024.
Certainly is not coming from Talicia because if sales numbers were good they would be releasing them. Instead radio silence.
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(Posted 12/22/2020)
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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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