midastouch017
2 months ago
RedHill-Supported Medscape H. Pylori Educational Program to Launch at Major Gastroenterology Congress
https://finance.yahoo.com/news/redhill-supported-medscape-h-pylori-110000775.html
RedHill supports an independent medical education grant that includes a new two-part H. Pylori Continuing Medical Education (CME) program, developed by Medscape aimed at advancing clinical knowledge and improving patient outcomes
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The first part of the program, led by a faculty of William Chey, MD, Vivian Asamoah, MD and Shailja Shah, MD, MPH, will take place May 6 during a major U.S. gastroenterology meeting
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H. pylori is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer[1] and a major risk factor for peptic ulcer disease[2]. With almost half the global population infected by H. pylori[3], its treatment represents a billion-dollar market opportunity[4]
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Listed by the American College of Gastroenterology (ACG) Clinical Guideline[5] as a first-line option, Talicia® is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists, and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics
RALEIGH, N.C., May 2, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its support of an independent medical education grant that includes a new two-part H. Pylori CME program, developed by Medscape and designed to advance clinical knowledge and improve patient outcomes. The first part of the program, a livestreamed event entitled "Let's Get Social About H. pylori Management" led by William Chey, MD, Vivian Asamoah, MD and Shailja Shah, MD, MPH, will take place on May 6 during a major gastroenterology meeting.
RedHill also announces that it will be attending Digestive Diseases Week (DDW) in San Diego and will be available at booth 5312.
Kel Sheldon, PhD, BCMAS, RedHill's Director, Medical Affairs, said: "We are proud to announce that RedHill is supporting a Medscape CME educational program to help meet the need for healthcare professional education on H. pylori infection and treatment options. RedHill believes in the critical need to effectively treat H. pylori at the first attempt amid increasing global concern of rising antibiotic resistance, particularly within the macrolide class of anti-infectives. H. pylori is estimated to be carried by around 50% of the global population and it is the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease. This CME program is targeted to help thousands of specialists, primary care providers, nurses, and advanced practice providers, by providing education on guideline-driven H. pylori management, designed to advance clinical knowledge and improve patient outcomes in H. pylori diagnosis and treatment."
The 2-part Medscape CME program consists of:
Part 1: Let's Get Social About H. pylori Management
Faculty: William Chey, MD; Vivian Asamoah, MD; Shailja Shah, MD, MPH
Date/Time: May 6, 2025, at 12 PM ET / 9 AM PT
Link to Event: Youtube -
LinkedIn - https://www.linkedin.com/events/7320172841423761409/
Facebook - https://www.facebook.com/events/1396855524656365
Overview: A 30-minute expert panel livestream (0.5 CME Credits) on Medscape's social media channels (YouTube, LinkedIn, Facebook, X), focusing on antibiotic resistance, guideline-directed therapies, and patient adherence in H. pylori management. The event will remain available on-demand post-livestream to support those gastroenterology professionals unable to attend the live event.
Part 2: Expert Roundtable: Overcoming Challenges in H. pylori Diagnosis and Treatment
Faculty: Colin Howden, MD; William Chey, MD; Shailja Shah, MD, MPH
Date/Time: June 2025 (TBD)
Overview: A 30-minute interactive, case-based online discussion (0.5 CME Credits), with Q&A, focusing on antibiotic resistance, adherence to new guidelines, and optimizing patient care pathways, in order to help clinicians translate key guideline updates into clinical practice.
H. pylori infection affects around 50% of the global adult population and is classified, by the World Health Organization (WHO), as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases)[6] and a major risk factor for peptic ulcer disease (causing 90% of cases)[7].
Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics, is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and is listed by ACG Clinical Guideline as an empiric first-line option. Talicia is also launched in the United Arab Emirates (UAE) and the Company recently announced its plan to submit a Marketing Authorisation Application (MAA) for Talicia in the UK, which if approved may be accepted by some additional countries as a reference for their own approval processes, which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35% of the U.S. population[8], with an estimated two million patients treated annually. Worldwide, around 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease 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 therapies[11].
About Talicia
Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia has received 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 is also approved by the United Arab Emirates (UAE) Ministry of Health and was launched there by Ghassan Aboud Group (GAG) in August 2024.
TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
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.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com.
midastouch017
2 months ago
RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107
https://finance.yahoo.com/news/redhill-biopharma-secures-allowance-key-110300040.html
Strong Use of Composition-of-Matter Coverage: Patent protects the molecular structure of RHB-107, providing market exclusivity beyond method-of-use claims
COVID-19 Therapeutic Use: Includes coverage for treatment of SARS-CoV-2, including wild-type and emerging variants
This patent grant enhances RedHill's strategic positioning in the global COVID-19 therapeutic space, a market still expected to be worth more than $3 billion in 2025[1], and expands its patent footprint in Asia, a key pharmaceutical market
RHB-107 successfully met the primary endpoint of safety and tolerability, delivering promising reduction in hospitalization efficacy results in a U.S. Phase 2 COVID-19 study[2]. Additional clinical data expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense
RHB-107 is a novel, patient-friendly oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations[3]
RALEIGH, N.C. and TEL-AVIV, Israel, April 28, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6).
"This newly allowed Chinese patent application is a significant success, enhancing RedHill's strategic positioning in the global COVID-19 therapeutic space – a market still expected to be worth more than three billion dollars in 2025. It provides broad and robust protection of the use of RHB-107, including its structure in oral formulations targeting SARS-CoV-2 infections, including both wild-type and naturally occurring variants and expanding its patent footprint in Asia, a key pharmaceutical market," said Guy Goldberg, RedHill's Chief Business Officer. "It underscores the uniqueness of our antiviral candidate and further strengthens our global intellectual property portfolio as we advance development of a much-needed oral candidate for early, community-based (non-hospitalized) treatment of COVID-19, which still represents a considerable threat to vulnerable patients. As a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations, RHB-107, if approved, could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Pfizer's Paxlovid."
Data from RHB-107's U.S. Phase 2 study, published in the International Journal of Infectious Diseases, 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 new severe COVID-19 symptoms reported by only 2.4% of the RHB-107 treated group (1/41) compared to 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036). Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with RHB-107 compared to 8 days with placebo. Additional clinical data is expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense.
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.
midastouch017
2 months ago
RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption
https://finance.yahoo.com/news/redhill-biopharmas-positive-opaganib-weight-110000215.html
GLP-1 comparable efficacy: Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models
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Novel mechanism of action, formulation and administration: Opaganib is a differentiated oral, non-peptide therapeutic that targets sphingosine kinase-2 (SPHK2), potentially avoiding common Glucagon-like peptide-1 (GLP-1) inhibitor side effects and administration burdens
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Market disruptor potential: The rapidly growing global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034[1] – largely driven by GLP-1 inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity®, Zepbound® and Mounjaro®
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Potential high value and de-risked development pathway: Existing human safety and tolerability data from over 470 subjects, from several clinical programs, may help expedite the FDA pathway to approval; new obesity and diabetes indications add strategic expansion and value to existing development programs in oncology, inflammatory and viral indications
TEL AVIV, Israel and RALEIGH, N.C., April 16, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the new publication[2] of positive in vivo data, in the journal Diabetes, Metabolic Syndrome and Obesity, in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet (HFD)-Induced Obesity and Glucose Intolerance". The data indicates that opaganib[3] effectively suppresses the loss of metabolic control in mice on a HFD, suggesting that opaganib, alone and in combination with semaglutide, is associated with improved glucose tolerance, decreased deposition of fat, weight loss and the prevention of weight gain rebound after removal of semaglutide.
Dr. Mark Levitt, Chief Scientific Officer at RedHill, said: "Sphingolipid metabolism is implicated in insulin resistance, ß-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications. The studies showed that treatment with opaganib markedly suppressed weight gain in mice fed the HFD but not in mice given the control diet (CD). Compared with mice given CD, mice on the HFD demonstrated poor glucose tolerance at 8, 12 and 16 weeks, consistent with the progression of obesity. Importantly, opaganib treatment of the HFD-fed mice abolished this developing glucose intolerance at all times of measurement. Opaganib treatment also reduced the elevation of hemoglobin A1c and the deposition of inguinal fat in HFD-fed mice. Opaganib and semaglutide were equally effective in promoting body weight loss and improving glucose tolerance in obese mice. Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells – the first known clinical drug to do so - provides a strong rationale for evaluation of opaganib in obesity-related disorders – and, as a first-in-class, orally administered, non-peptide option, opaganib could potentially represent a game-changing opportunity in the multi-billion-dollar obesity and diabetes market."
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 – largely driven by GLP-1 inhibitors like Novo Nordisk's Ozempic and Wegovy (semaglutide) and Eli Lilly's Trulicity (dulaglutide) and Mounjaro / Zepbound (tirzepatide).
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 indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), chemical exposure indications, 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).
Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA).
A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study has also been initiated to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis.
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 Microorganisms.
Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in solid tumors (Phase 1), 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, gastrointestinal and diabetes/obesity-related indications.
midastouch017
2 months ago
RedHill Biopharma Announces Full-Year 2024 Financial Results and Operational Highlights
Revenue-generating with an exciting, diversified, largely externally funded, advanced development pipeline and multiple upcoming catalysts. Recent highlights:
Global licensing deal (excluding North America) with Hyloris Pharmaceuticals with RHB-102 for up to $60 million in potential milestone payments
Approximately $8 million plus legal costs NY Supreme Court summary judgment win against Kukbo
Bayer-supported Phase 2 combination study of opaganib and Bayer's darolutamide in prostate cancer initiated
Talicia® advancement and geographic expansion:
Planned UK MAA with potential for approval in 2025
Commercially launched in the United Arab Emirates (UAE)
Formulary wins securing 25 million covered lives
First-line therapy listing in the recently updated ACG Guideline
Advancing next-generation development, RHB-204, into the first ever Phase 2 clinical study in Crohn's Disease (CD) patients who are all MAP-positive, supported by RHB-104's positive Phase 3 data showing a statistically significant 64% improvement in efficacy; FDA path to approval guidance expected in coming weeks
Positive results from new U.S. Government funded program for gastrointestinal Acute Radiation Syndrome (GI-ARS) further confirm opaganib's nuclear radiation protective activity. Discussions ongoing regarding advanced development
Cash balance of $4.8 million as of December 31, 2024
23% increase in net revenues in 2024 to $8.0 million, up from $6.5 million in 2023
Supported by extensive cost-cutting measures, the Movantik® divestiture transaction and reduced R&D spend, cash burn slashed by 74% year-over-year; Net cash used in operations dropped to $9.4M from $35.8M in 2023
TEL AVIV, Israel and RALEIGH, N.C., April 10, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full-year 2024 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2024.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have undergone an extensive overhaul reshaping ourselves financially, operationally and strategically. Major corporate and R&D moves, undertaken over the last 12 months, have resulted in new and clearer opportunities to deliver maximum value from both our commercial and R&D assets. The potential $60 million ex-North America global license of RHB-102 to Hyloris lays the groundwork for the ongoing development and commercialization in the large gastroenteritis, oncology support and IBS-D markets while enabling RedHill to maintain control of the key North American markets. The approximately $8 million plus legal costs New York Supreme Court summary judgment was a resounding win for RedHill and we are fully committed to pursuing the collection of this award. Last year's recommendation by the latest ACG Clinical Guideline for Talicia as a first-line therapeutic option for H. pylori eradication, has, we expect further enhanced Talicia's product profile as the leading branded U.S. gastroenterologist prescribed H. pylori therapy, winning additional formulary successes securing 25 million covered lives. After its successful launch in UAE, Talicia is also poised for a potential UK Marketing Authorisation Application (MAA) mid-year, presenting a promising pathway for Talicia's entry into additional markets globally."
Mr. Ben-Asher continued: "Having successfully completed the Hyloris RHB-102 out-license deal, we are now advancing our next-generation candidate, RHB-204, in the $12 billion Crohn's disease space, employing a novel, groundbreaking approach, supported by RHB-104's positive Phase 3 clinical data. In parallel, opaganib continues to show its broad-acting potential and we are very excited to have initiated the innovative Bayer-supported Phase 2 study in combination with darolutamide, which may bring vital new hope to men with metastatic castrate resistant prostate cancer. Progress was also made with opaganib as a treatment for GI-ARS following positive results from new in vivo studies, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirming opaganib's radioprotective activity in models of GI-ARS. Discussions are ongoing regarding advanced development. Additionally, the ongoing U.S. Government-supported work in Ebola continues following our previously announced BARDA grant. We have started 2025 as we mean to go on – aggressively pursuing our business goals and aiming to deliver on our catalysts in a meaningful way."
Financial results for the 12 months ended December 31, 20242
Net Revenues for the year ended December 31, 2024 were $8.0 million, compared to $6.5 million for the year ended December 31, 2023. Talicia net revenues for the year ended December 31, 2024, increased to $9.0 million from $8.8 million for the year ended December 31, 2023, driven by approximately $1.0 million of revenues generated from the UAE partnership with Gaelan Medical. Net revenues for the years ended December 31, 2024 and December 31, 2023 included Movantik contra-revenues of $0.9 million and $2.6 million for Movantik, respectively, mainly due to product returns.
Cost of Revenues for the year ended December 31, 2024 was $3.2 million, compared to $3.5 million for the year ended December 31, 2023. The decrease was primarily due to lower inventory write-downs, which totaled $0.2 million in 2024 compared to $1.3 million in 2023.
Gross Profit for the year ended December 31, 2024 was $4.9 million, compared to $3.1 million for the year ended December 31, 2023, reflecting the increase in net revenues and the lower level of inventory write-downs in 2024.
Research and Development Expenses for the year ended December 31, 2024 were $1.6 million, as compared to $3.5 million for the year ended December 31, 2023. The decrease was attributable to the costs from closing the RHB-204 clinical trial, which were recognized in 2023, as well as ongoing cost-reduction measures.
Selling, Marketing, and General and Administrative Expenses for the year ended December 31, 2024 were $15.5 million, as compared to $31.0 million for the year ended December 31, 2023. The reduction was primarily attributable to ongoing cost-reduction measures and the divestment of Movantik in 2023, which led to workforce downsizing and other related expense reductions.
Other Expenses for the year ended December 31, 2024 were $2.3 million, recognized as part of the Global Termination Agreement3, as compared to Other Income of $44.1 million for the year ended December 31, 2023. The Other Income in 2023 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 provided to the buyer of Movantik.
Operating Loss for the year ended December 31, 2024 was $14.6 million, compared to Operating Income of $12.6 million for the year ended December 31, 2023. Both periods include items related to the Movantik divestiture, as described under Other Expenses - a $2.3 million loss in 2024 and $44.1 million income in 2023. Excluding these, the year-over-year change reflects improved operating performance driven by cost-cutting measures.
Financial Income, net for the year ended December 31, 2024 was $6.3 million, compared to Financial Income, net of $11.3 million for the year ended December 31, 2023. The income recognized for the year ended December 31, 2024, was primarily driven by the revaluation of financial instruments, partially offset by other financing expenses. 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 HCRM 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 financial instruments and other financial expenses.
Net Loss for the year ended December 31, 2024 was $8.3 million, as compared to Net Income of $23.9 million for the year ended December 31, 2023. Both periods include impacts from the Movantik divestiture, as detailed under Other Expenses and Financial Income - a $2.3 million loss in 2024 and $64.7 million in income in 2023. Excluding these, the year-over-year change reflects improved performance driven by cost cutting measures.
Total Assets as of December 31, 2024 were $18.0 million, as compared to $23.0 million as of December 31, 2023. The decrease was primarily attributable to the decrease in cash balance, reduced inventory and a decline in prepaid expenses and other receivables, consistent with the Company's scaled-down operations, as well as impact of balances settled as part of the Global Terminations Agreement, and a reduction in right-of-use assets following the termination of vehicle leases during 2024.
Total Liabilities as of December 31, 2024 were $22.7 million, as compared to $21.0 million as of December 31, 2023. The increase primarily reflects the impact of the Global Termination Agreement, under which the Company incurred liabilities related to Movantik that were allocatable to HCRM and its affiliates under their agreements with the Company, offset by payments made toward these liabilities during the period. Additionally, there was an increase in derivative financial instruments associated with warrant liabilities from offerings made during 2024. This was partially offset by a decrease in accounts payable and allowance from deductions from revenues, consistent with the Company's scaled-down operations, as well as a reduction in lease liabilities due to the termination of car leases.
Net Cash Used in Operating Activities for the year ended December 31, 2024 was $9.4 million, compared to $35.8 million for the year ended December 31, 2023. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities. This was partially offset by proceeds received from the Global Termination Agreement, net of payments made to settle obligations arising from this agreement.
Net Cash Provided by Financing Activities for the year ended December 31, 2024 was $8.4 million, primarily generated through equity offerings. Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023, July 2023, September 2023 and November 2023, and from decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchases.
Cash Balance as of December 31, 2024, was $4.8 million1.
Commercial and R&D Highlights:
Commercial - streamlined and revenue-generating:
With a significantly streamlined commercial operation, Talicia has generated net revenues of $9.0 million, supported by approximately $1.0 million of new revenues from the UAE partnership with Gaelan Medical, and remains the leading U.S. gastroenterologist-prescribed branded H. pylori therapy.
Significant effort has resulted in important accomplishments with Talicia, such as the inclusion as first-line option for treatment of H. pylori infection in the recently updated 2024 American College of Gastroenterology (ACG) Clinical Guideline, the securing of 25 million covered lives following the Medi-Cal renewal and Humana formulary win, a successful launch in the UAE and the potential for opening up new markets with the recently announced plan for a Talicia UK MAA. Talicia has now surpassed the 100,000 prescriptions milestone and our innovative warranty program, with minimal refunds claimed, reflects a positive patient experience.
R&D - focused on new opportunities:
Largely externally funded, with multiple U.S. Government and non-governmental collaborations, RedHill's pipeline provides new and exciting opportunities in major indications: Crohn's disease, prostate cancer, diabetes and obesity-related disorders, Ebola and other viral and pandemic preparedness indications as well as for gastrointestinal-acute radiation syndrome (GI-ARS) and other medical/chemical countermeasure uses:
Opaganib4:
A potentially broad acting, novel, oral, host-directed small molecule drug, with a demonstrated safety and efficacy profile, advancing in predominantly U.S. Government-supported, externally funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval.
Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including prostate cancer, COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection, including GI-ARS:
A new approach in the $12 billion prostate cancer market:
Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths5. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them.
In February 2025, the Company announced the initiation of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis.
The study will utilize a companion lipid biomarker test (PCPro) to select mCRPC patients who have a poor prognosis due to standard of care (SoC) treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The primary endpoint will be improved 12-month radiographic progression-free survival (rPFS).
Other opaganib programs/updates include:
U.S. Army and BARDA-grant funded program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
U.S. Government- and non-government funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for GI-ARS and Phosgene inhalation injury. On December 10, 2024, the Company announced positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. Government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract. These results further confirm opaganib's protective activity in models of GI-ARS and discussions are ongoing regarding advanced development.
Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade. 'Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance' was recently published6 in the journal Diabetes, Metabolic Syndrome and Obesity
Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology)
ARDS, COVID-19 and Influenza programs continue to seek to address multi-hundreds of millions of dollars markets
RHB-204:
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease (CD). Unlike existing therapies that focus on symptom relief, RHB-204 is intended to target the possible root cause of Crohn's disease, which is hypothesized to be caused by Mycobacterium avium subspecies paratuberculosis (MAP).
Patent protected until at least 2041, RHB-204 is a next-generation formulation of RHB-104, which successfully completed a Phase 3 study in Crohn's disease, with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD.
Paradigm shift in MAP-positive CD treatment approach
In March 2025, the Company announced its plans to advance its potentially groundbreaking late-stage RHB-204 Crohn's disease program, building on statistically significant positive RHB-104 Phase 3 results. FDA guidance on pathway to approval is anticipated in the coming weeks. RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment.
The planned innovative Phase 2 study of RHB-204 is planned to be the first ever clinical study in CD patients who are all MAP-positive and will evaluate mucosal healing, a new gold standard in assessing efficacy in Crohn's disease, and MAP eradication utilizing novel and decisive endpoints and imaging, allowing for a study design with a relatively small sample size.
RHB-204 builds upon RHB-104's successful Phase 3 study, which successfully met its Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus standard of care. It also showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes.
RHB-107 (upamostat) update:
On January 30, 2025, we were notified that funding from the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination, requiring the study to cease enrollment on Feb 28, 2025. 93 patients have been enrolled out of a fully enrolled target patient population of 300. Due to the reduced number of patients enrolled in this study, the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial.
The U.S. Army-funded Ebola development program remains ongoing, with RHB-107 having demonstrated a 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.
Annual Report:
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at:
https://www.redhillbio.com/investors/financial-filings/quarterly-reports/default.aspx.
The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at:
investors@redhillbio.com.
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