RedHill Biopharma : Corporate Presentation
RDHL
Published on 05/17/2026 at 07:21 am EDT
RedHill Biopharma Ltd.
Corporate Presentation May 2026
Emerging U.S. specialty biopharmaceutical company (Nasdaq: RDHL), primarily focused on U.S. commercialization and development of drugs for gastrointestinal (GI) diseases, infectious diseases and oncology
Strong U.S. Commercial Footprint and Robust Development Pipeline
Net Revenues FY 2025
$7.8M*
Late-Clinical-Stage Pipeline
Multiple de-risked programs and successfully completed Phase 3 studies
Strengthened
U.S. Commercial
Organization
Partnered with Cumberland Pharma for the co-commercialization of Talicia®
* Includes continuing and discontinued operations.
#1 branded H. pylori Rx among U.S. Gastroenterologists
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Commercial Productii
Talicia® (H. pylori infection in adults) | U.S. Co-Commercialization Partnership with Cumberland Pharma.|
Development Pipeline
Preclinical Phase 1/2
Phase 3 NDA
Opaganib
(ABC294640)
Anticancer
Antiviral
Anti-inflammatory
Metabolic
disorders
Oncology
Virus-induced ARDS* Ebola virus
Diabetes and obesity
Phase 2 oncology programs
Phase 2/3 COVID-19 (ARDS)
Preclinical stage Preclinical stage
Includes the DARO LIPID Trial | ongoing Phase 2 combination study with Bayer's darolutamide in prostate cancer
GI-ARS† (Radioprotection)
Preclinical stage
Pursuing FDA Animal Rule pathway
RHB-102
(Bekinda®)iii
GLP-1/GIP-associated GI Intolerance
Gastroenteritis IBS-D
Oncology support
Planned Phase 2 proof-of-concept
Positive results from a first U.S. Phase 3 study Positive results from U.S. Phase 2 study
UK MAA‡ planned
In partnership with Hyloris Pharma. (ex-North America)
RHB-204
RHB-107
(upamostat)
Antiviral
Crohn's disease
Pulmonary NTM§ disease
COVID-19, Oncology/GI
Phase 2-stage Phase 3-stage
Phase 2 COVID-19, GI & oncology indications
* ARDS: Acute respiratory distress syndrome;
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† GI-ARS: Gastrointestinal acute radiation syndrome; ‡ MAA: Marketing Authorisation Application; § NTM: Nontuberculous mycobacteria. i Estimated timeline/indication in the pipeline is subject to changes in development plans and regulatory requirements/clarifications, including complementary /additional studies; ii For full Talicia® prescribing information, see: www.talicia.com; iii Bekinda® (RHB-102) is the proposed tradename which is subject to FDA review and approval at the time of NDA filing.
RedHill Biopharma Ltd.
Nasdaq: RDHL
Market Cap (approx.)i $5.2 million American Depositary Shares (ADSs) (approx.) 5.2 million FY 2025 (Fiscal Year Ended Dec 31, 2025):
Cash Balanceii $4.1 million
Net Revenuesiii $7.8 million
Gross Marginiii 74.6%
Equity Financing Capacityiv $31.7 million
i Financial information as of May 8, 2026, unless otherwise noted. ii Including cash, cash equivalents, short-term bank deposits and restricted cash. iii Includes continuing and discontinued operations. iv "Any Market Purchase Agreement", announced in June 2025; SEPA (Standby Equity Purchase Agreement), announced
in December 2025. 5
Dror Ben-Asher, Chief Executive Officer
P.C.M.I. Ltd.
Razi Ingber, Chief Financial Officer
PwC
Adi Frish, Chief Corporate & Business Development Officer
Y. Ben-Dror, MediGus
Gilead Raday, MSc, Mphil, Chief Operating Officer
Sepal Pharma, Charles Street Securities LLP
Rick D. Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer
Salix, Watson, Oclassen
Guy Goldberg, Chief Business Officer
Eagle Pharma, ProQuest, McKinsey
Mark L. Levitt, MD, PhD, Chief Scientific Officer
NCI, Teva, Inotek, Immune Pharma
Reza Fathi, PhD, Senior VP R&D
XTL, PharmaGenics, Harvard Inst. of Chem. & Cell Biology
Patricia Anderson, Senior VP Regulatory Affairs
MAPI Group, OptumInsight, Bayer, Novopharm
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Dror Ben-Asher, CEO
P.C.M.I. Ltd.
Kenneth Reed, MD
Dermatologist; Director Minerva Biotechnologies
Dr. Roni Mamluk, PhD
Ayala Pharmaceuticals, Chiasma
Shmuel Cabilly, PhD
Scientist, Director in several life-science companies
Rick D. Scruggs
Salix, Watson, Oclassen
Ofer Tsimchi
Danbar, Polysack, Director in several companies
* Includes select past positions
7
U.S. Co-Commercialization Partnership Designed to:
Accelerate Talicia sales growth
Leverage Cumberland's expanded national GI sales promotion and marketing support
Deliver significant efficiencies through shared operational responsibility
"A strong growth opportunity for both companies"
A.J. Kazimi, CEO
Combined U.S. commercial operations focused on commercialization to thousands of gastroenterologists (GIs), advanced practice providers (APPs), and primary care providers (PCPs)
Indicated for the treatment of Helicobacter
pylori (H. pylori) infection in adults
U.S. launch in Q1/20
Leading Branded H. pylori Therapy among U.S.
Gastroenterologistsi
*RedHill announced on Oct 20, 2025, a strategic partnership with Cumberland Pharmaceuticals Inc., incl. $4 million strategic investment for a 30% ownership stake in RedHill's global Talicia business and co-commercialization agreement for Talicia (See PR here); Restructuring of the commercial operations is currently ongoing. † On April 23, 2026, Cumberland and Apotex, a Canadian-based global health company, announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex.
i IQVIA XPonent Plantrak 12 months ending September 2025 8
Indicated for the treatment of Helicobacter pylori infection in adults
Approved for Marketing by U.S. FDA Following Two Phase 3 Studies Launched in the U.S. and the United Arab Emirates (UAE)
Listed as First-Line Option for Treatment of H. pylori Infection in the 2024 American
College of Gastroenterology (ACG) Guideline*
*Chey WD, et al. ACG Clinical Guideline: Treatment of Helicobacter Pylori Infection. American Journal of Gastroenterology. 2024; 119(9): 1730-1753. 9
Approved Indication
Drug
Regulatory Status
Key Attributes
Market Exclusivity
Market Size
Treatment of H. pylori infection in adults
Omeprazole magnesium, amoxicillin and rifabutin 10.3 mg/ 250 mg/ 12.5 mg delayed-release capsulesi
− U.S. FDA approved (2019); United Arab Emirates (UAE) approved (2024); UK MAA* planned
High rates of H. pylori eradication (>90%) achieved in confirmed adherent populationi
Zero to minimal H. pylori resistance to rifabutin and amoxicillin reportedii
Simple regimen (all-in-one oral capsule) with a single prescription
Flexible dosing schedule (4 capsules TID at least 4 hours apart for 14 days)
Generic rifabutin is commercially available only as 150 mg capsules in the U.S. and is not therapeutically equivalent to the low-dose formulation of rifabutin found in Talicia (50 mg, TID)iii
− U.S. patent protection until 2042
− FDA QIDP designation granted, providing 8 years of market exclusivity (initially 3 years, extended by 5 under QIDP) through 2027
− Affects over 50% of the world populationiv, with ~1.6 million U.S. patients treated annuallyv
− High levels of government (7/10 lives) and commercial (6/10 lives) coverage
.i Each delayed-release capsule contains omeprazole 10 mg (equivalent to 10.3 mg omeprazole magnesium), amoxicillin 250 mg, and rifabutin 12.5 mg. ii Confirmed adherent population included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at Visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. ii Resistance rates as determined by in vitro testing of 345 H. pylori isolates collected at baseline from patients enrolled in the Talicia pivotal trial. iii Talicia 50 mg, three times daily (TID), had higher intragastric exposure times than 150 mg once daily or twice daily, or 300 mg once daily generic rifabutin; Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology & Therapeutics. 2023;58(2):159-167. iv Hooi JKY et
al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. v IQVIA Custom Study for RedHill Biopharma, 2021. 10
H. pylori Overview and
FDA recognizes
IARC*/(WHO)
H. pylori is listed as a
WHO identifies antimicrobial
H. pylori as a potential
classifies H. pylori as
human carcinogen in the
resistance (AMR) as one of the
serious public health
a Group 1
HHS NTP 2021 HHS
top global public health and
threati
carcinogen
Report on Carcinogens
development threatsii
H. pylori is a gram-negative bacterium that colonizes gastric mucosa
Infection with H. pylori is the most common chronic bacterial infection in humansiii:
It affects over 50% of the global population; In the U.S., approx. 35% of the population are affectediv, with around 1.6 million patients treated annuallyv
Chronic H. pylori infection is the strongest known risk factor for gastric cancer, the 5th leading cause of cancer related deaths worldwide, accounting for almost 1 million new cases and over 1.3 million deaths in 2022vi
Confirmed eradication of H. pylori leads to a ~75% decreased risk of gastric cancervii
Infection is also associated with other conditions, including dyspepsia, peptic ulcer disease, primary gastric B-cell lymphoma, vitamin B12 deficiency, iron deficiency anemia and mucosa-associated lymphoid tissue (MALT) lymphomaviii
Commonly used therapies fail in approx. 25% to 40% of patients due to growing antimicrobial resistance of
H. pylori to regimens containing antibiotics such as clarithromycin and metronidazoleix
IARS: International Agency for Research on Cancer, the specialized cancer research agency of the World Health Organization (WHO). i FDA, Department of Health and Human Services. 21 CFR Part 317: Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health. eCFR. Available at: https://www.ecfr.gov/current/title-21/part-317. Accessed March 2025. ii World Health Organization. Antimicrobial Resistance. Fact Sheet, 21 Nov. 2023. World Health Organization, WHO, 2023. iii Chey WD, et al. ACG Clinical Guideline: Treatment of Helicobacter Pylori Infection. American Journal of Gastroenterology. 2024; 119(9): 1730-1753. iv Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420-429. v IQVIA Custom Study for RedHill Biopharma, 2021. vi World Cancer Research Fund. Stomach Cancer Statistics. WCRF, accessed 3 Dec. 2025. vii Kumar S, et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology. 2020;158(3).viiiVakil N, et al. Physiologically Based Pharmacokinetic Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025; Malfertheiner et al. Nat Rev Dis Primers. 2024; National Toxicology Program. Report on Carcinogens, 15th ed. U.S. Dep. of Health and Human Services. 2021. Helicobacter pylori (Chronic Infection). ix Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report. Gut. 2012;61(5):646-664; O'Connor A, et al. Treatment of Helicobacter Pylori Infection 2015. Helicobacter. 2015;20(S1):54-61; Venerito M, et al. Meta-Analysis of Bismuth
Quadruple Therapy versus Clarithromycin Triple Therapy for Empiric Primary Treatment of Helicobacter Pylori Infection. Digestion. 2013;88(1):33-45. 11
Talicia® - A Rational and Effective Choice for H. pylori Therapy
Recommended as
first-line treatment of
H. pylori in American College of
Gastroenterology
(ACG) Guideline
Only
all-in-one formulation with simplified dosing
Generically substituted rifabutin-triple therapy is not bioequivalent to Talicia®i
>90% H. pylori eradication in confirmed adherent population regardless of obesity/BMI or type 2 diabetes statusii
Safe and well-tolerated
in two U.S.
Phase 3 Trials
Addressing diminishing efficacy of SoC therapies due to growing
H. pylori
resistance
i Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology & Therapeutics. 2023;58(2):159-167. ii Kao, JY et al. Helicobacter Pylori Eradication by Low-dose Rifabutin Triple Therapy (RHB-105) Is Unaffected by High
Body Mass Index. GastroHep, 2021, 3(7), 426-434. 12
Talicia®: Listed as empiric first-line option by >15 peer-reviewed publications including the 2024 American College of Gastroenterology (ACG)
H. pylori Treatment Guideline
Furthermore, the 2024 ACG Guideline recommends against the use of clarithromycin as part of any treatment regimen without prior susceptibility testingi
Since Talicia® does not contain clarithromycin, there is no risk of possible clarithromycin resistance, eliminating the need for antimicrobial sensitivity testing prior to treatment
i Chey WO, Howden CW, Moss SF, et al. ACG Clinical Guideline: treatment of Helicobacter pylori infection. Am) Gastroenterol. 2024;1 12(9): 1730 -1753. 13
Talicia Access: More than 200 Million American Lives have Formulary Coveragei
Talicia Lives Covered • Talicia is Preferred on Aetna,
OptumRx, and Express Scripts
Commercial Formularies
7 out of
10 lives 6 out of
10 lives
Government Commercial
Talicia is covered on Medi-Cal, California's Medicaid Program, with no PA/ST or restrictions and a $0 copay
Talicia is now covered on Humana's Medicare Part D Formulary, the VA National Formulary, and Preferred on TennCare
i Estimated coverage based on Clarivate® Fingertip Formulary as of April 1, 2026.
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The ERADICATE Hp2 study met its primary endpoint with a high degree of statistical significance (p<0.0001)
Primary endpoint: ¹³C UBT at 43-71 days post treatment ITT analysis
Number of subjects: 455 in the U.S.
Eradication rate of 83.8% in the ITT population receiving Talicia vs. 57.5% with active comparator (∆26.1%); p-value<0.0001
90% eradication based on adherence analysis (confirmed adherent population*) using protocol-defined population with evidence of drug ); p-value<0.0001
No safety signals reported
No AEs related to myelotoxicity
Well tolerated
n=228 n=227
ITT Population
n=207 n=184
Confirmed Adherent Population
IIT population included all randomized patients who received at least one dose of study drug; Confirmed adherent population included those subjects in the ITT population who had demonstrated
presence of any component of investigational drug at Visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
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across 20 U.S. states and tested for antibiotic resistance
Results confirmed high resistance of H. pylori to antibiotics com other therapies vs. zero to negligible resistance for the compon Talicia®:
monly used in ent antibiotics in
Antibiotics Commonly Used in Other Therapies
Antibiotics Contai
ned in Talicia®
Antibiotic
H. Pylori Resistance Rate
Antibiotic
H.
Pylori Resistance Rate
Clarithromycin
(n=345)
60 (17.4%)
Rifabutin (n=345)
0 (0%)
Metronidazole (n=344)
150 (43.6%)
Amoxicillin (n=345)
22 (6.4%)
345 H. pylori isolates were collected at baseline from treatment naïve patients
i Hulten, K. G., et al. National and regional US antibiotic resistance to Helicobacter pylori: Lessons from a clinical trial. Gastroenterology.
2021.161(1), 342-344.e1. 16
A Randomized Placebo-Controlled Phase 3 Study (ERADICATE Hp) to Assess the Safety and Efficacy of Talicia® in the Treatment of Confirmed H. pylori Infection in Dyspepsia Patients, Regardless of Ulcer Status
Number of Subjects Treatment Duration
118 in the U.S. 14 days
Primary Endpoints
The occurrence of H. pylori eradication as confirmed via 13C UBT testing 28-35 days after completion of treatment
Greater eradication of H. pylori infection over historical standard of care efficacy levels of 70% effectiveness
Positive Phase 3 Results
Study met protocol-defined primary endpoint - demonstrating 89.4% efficacy in eradicating H. pylori infection (p< 0.001) in the mITT populationi
63% eradication rate demonstrated in open-label treatment of treatment naïve placebo-arm patients with physician choice therapy (mostly clarithromycin triple therapy) for persistent H. pylori infection
No serious adverse events related to the drug were noted in the study
i mITT Population included those subjects who completed the study and returned for a follow-up test of cure. 17
Talicia® is covered by a portfolio of U.S. patents, including those for its unique 'all-in-one' capsule formulation and distinct PK profile, among others, with the latest patent set to expire in 2042; Additional patents have been granted and more applications are pending in various territories worldwide
FDA QIDP designation granted, providing 8 years of market exclusivity
(initially 3 years, extended by 5 under QIDP) through 2027
Generically substituted rifabutin-triple therapy is not bioequivalent to Talicia®i
- Unique low-dose (50 mg TID) rifabutin formulation is not commercially
available and cannot be replicated by prescribers
Indication allowing unique labeling, marketing and promotional opportunity
'All-in-one' easy to use regimen with single co-pay preferred over more cumbersome regimens
i Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology &
Therapeutics. 2023;58(2):159-167. 18
Talicia® (omeprazole magnesium, amoxicillin and rifabutin) -
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 rifamycins.
Talicia® is contraindicated in patients receiving delavirdine, voriconazole or rilpivirine-containing products.
Serious and occasionally fatal hypersensitivity reactions have been reported with the components of Talicia®: omeprazole, amoxicillin and rifabutin.
Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN) have been reported with the components of Talicia®: rifabutin, amoxicillin, and omeprazole. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile - associated diarrhea has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia® may cause fetal harm and is not recommended for use in pregnancy. It may also 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 and systemic lupus erythematosus 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.
Please also see complete Prescribing Information 19
RHB-102 (Bekinda®) - In partnership with Hyloris Pharma (ex-North America)
GLP-1/GIP-associated GI Intolerance
Planned Phase 2 proof-of-concept (PoC) study
Gastroenteritis & gastritis
First U.S. Phase 3 study successfully completedii
Irritable bowel syndrome with diarrhea (IBS-D)
U.S. Phase 2 study successfully
completed; Phase 3 ready
Oncology support
UK MAA* planned
Opaganib (ABC294640)
Prostate cancer
Ongoing Phase 2 study evaluating opaganib
in combination with Bayer's darolutamide
Cholangiocarcinoma
Phase 2a study completed
Neuroblastoma and chronic lymphocytic leukemia
Preclinical data support potential as an add on therapy; neuroblastoma: Phase 2 ready
Virus-induced ARDS† (incl. COVID-19 & influenza)
Phase 2/3 readyiii; Phase 2/3 study in hospitalized COVID-19 patients completed
Ebola virus disease and other viral infections
Preclinical stage
Additional preclinical evaluation ongoing with NIAID for various antiviral indications
Metabolic disorders (diabetes and obesity)
Preclinical stage
GI-ARS‡
Preclinical stage, with development under FDA Animal Rule
Inflammatory bowel disease
Phase 2 ready
RHB-107 (upamostat)
COVID-19 (symptomatic outpatients)
Phase 2a study successfully completed
Included in a separate U.S. Gov.-supported Phase 2 platform trial for early COVID-19 outpatient treatment (PROTECT study) - study terminated
Influenza
Preclinical stage
Pancreatic & breast cancer
Phase 2 PoC study completed
RHB-204
Crohn's disease
Phase 2 study planned
Pulmonary nontuberculous mycobacterial (NTM) disease
Phase 3-stage
*MAA: Marketing Authorisation Application. † ARDS: Acute respiratory distress syndrome; ‡ GI-ARS: Gastrointestinal acute radiation syndrome.
i Additional elaborated information can be found in this presentation and RedHill's ongoing public filings. ii Confirmatory Phase 3 study is required and planned to support a potential NDA for RHB-102 (24 mg) for acute gastroenteritis
and gastritis. iiiData obtained from the Phase 2/3 COVID-19 study to support the potential Phase 2/3 study ARDS. 20
Disclaimer
Redhill Biopharma Ltd. published this content on May 17, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 17, 2026 at 11:20 UTC.