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Can-Fite: FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study
https://finance.yahoo.com/news/fite-fda-grants-ind-clearance-110000893.html
RAMAT GAN, Israel, May 09, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study.
Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH. Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment of patients in the US.
The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.
"The IND activation for the treatment of MASH patients with Namodenoson, opens the gate for the enrolment of US based patients and will contribute to the heterogeneity of the population of this study," said Motti Farbstein, Can-Fite CEO. " As we are already enrolling patients for this study, we hope that in the next few months, we will complete recruitment. We are committed to improve the lives of MASH patients and based on the efficacy of the drug in the Phase IIa study, we are proud to develop a new potential treatment to address this disease."
Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market.
Will this news move the needle north?
I doubt it, patents are only $ worth if
commercial use is made, eg some
BP buys it.
Can-Fite Received Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602
https://finance.yahoo.com/news/fite-received-notice-allowance-european-110000150.html
Patent has already been issued in other major markets including the U.S.
PETACH TIKVA, Israel, May 06, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the European Patent Office for its patent application titled "An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction". This invention addresses the use of the CF602 drug candidate as an oral or topical drug for patients such as diabetics, who suffer from erectile dysfunction, and cannot use the current drugs on the market.
While oral phosphodiesterase type 5 (PDE5) inhibitors are the current standard of care for erectile dysfunction (ED), with brands including Viagra, Cialis, Levitra, and Stendra, an estimated 30% to 35% of ED patients are non-responders, and these drugs can be contraindicated for people living with diabetes.
Can-Fite recently published an article in Andrologia, suggesting that CF602 could potentially offer an alternative to the current drugs on market. A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle/collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase. treatment to PDE5 inhibitors, particularly to PDE5 non-responders and diabetics.
"This additional European patent for erectile dysfunction adds to our growing IP estate for this high-value indication of the CF602 drug candidate. We believe our strong and broad IP, together with the pre-clinical positive data position it as a promising candidate for further development for the treatment of sexual dysfunction," stated Motti Farbstein, Can-Fite CEO.
The Erectile Dysfunction market is expected to reach approximately $6.6 billion by 2030, according to Market Research Future.
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.
BioLineRx Announces Poster Presentation on Economic Model Data for APHEXDA® (motixafortide) as part of CD34+ Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma at ISPOR 2024
https://finance.yahoo.com/news/biolinerx-announces-poster-presentation-economic-110000857.html
- Presentation Today, Monday, May 6, 2024 in Atlanta, Georgia -
TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia.
Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3 Uncertainty in stem cell mobilization and the possible need for multiple apheresis sessions may result in psychological and logistical burden on patients, in addition to financial and operational inefficiencies for apheresis centers.
The new economic model assessed the cost and healthcare resource utilization impacts of multiple apheresis attempts via a comparison between daily filgrastim (G-CSF) alone and in combination with APHEXDA, and an indirect comparison between daily filgrastim used with either plerixafor or APHEXDA, using drug costs from Micromedex, procedure costs from CMS.gov and data for apheresis days obtained from clinical trials and product labels. The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024.)
Poster Presentation at ISPOR 2024
Georgia World Congress Center, Atlanta, Georgia
Poster Session Details
Poster: Number EE148
Title: The Institutional Level Impact of Additional Apheresis Days for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation on Costs and Healthcare Resource Utilization
Presenter: Jeffrey R Skaar, PhD, Trinity Life Sciences, New York, NY and Jennifer L Lessor, MPH, BioLineRx USA, Inc., Waltham, MA
Poster Session: Economic Evaluation
Date: Monday, May 6, 2024
Time: 3:30 PM - 6:30 PM
The new economic model data to be presented at ISPOR 2024 builds on the evaluation of APHEXDA for CD34+ HSC mobilization in patients with multiple myeloma in apheresis center operations.
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize = 6 million CD34+ cells in one apheresis session.
Yep, you wrapped it up nicely.
Still, i am somehow hopeful, but
for sure will not add to what i already own.
Something similar i would hope for:
MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care Conferences
https://finance.yahoo.com/news/mediwound-present-data-escharex-phase-120000249.html
Oral presentations include additional comparative data between EscharEx® and SANTYL®, and new analyses show strong correlation between wound bed preparation and wound healing
Analyses validate the planned design and endpoints of the upcoming Phase III study
YAVNE, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today that recent clinical data from EscharEx® Phase II studies will be presented throughout May 2024 at the largest, most prestigious annual meetings in the field of chronic wound care: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC).
The oral presentations on EscharEx will include:
Comparative data of EscharEx vs. SANTYL® that demonstrate EscharEx’s superiority over the current leading enzymatic debridement agent
New analyses from the ChronEx phase II study, showing high correlation between wound bed preparation and wound healing
These data indicate that EscharEx could substantially improve wound care for patients with debilitating chronic wounds, providing significant benefits over the current standard of care. Additionally, the findings support the design and endpoints of the upcoming Phase III study, which is expected to begin in the second half of 2024.
"We are delighted to present the results of additional analyses from EscharEx Phase II studies in chronic hard-to-heal wounds, including the positive comparative data with SANTYL®, the current dominant standard of care for enzymatic debridement," said Dr. Robert J. Snyder, Chief Medical Officer of MediWound. "With its robust efficacy, favorable safety profile, and multimodal mechanistic effects demonstrated in these Phase II studies, we believe that EscharEx can significantly advance wound care and has the potential to become a major player in the global wound care market."
2024 European Wound Management Association (EWMA), London, United Kingdom
Time:
May 1, at 11:45am
Title:
Comparison of bromelain-based enzymatic debridement to collagenase ointment
Presenter:
Cyaandi R. Dove, DPM
Time:
May 3, at 8:30am
Title:
VLU wound bed preparation is highly correlated with wound closure
Presenter:
Robert J. Snyder, DPM, MSc, MBA
2024 Wound Healing Society Conference (WHS), Orlando, Florida
Time:
May 16, at 10:30am
Title:
Comparison of bromelain-based enzymatic debridement to collagenase SANTYL® ointment
Presenter:
Cyaandi R. Dove, DPM
Time:
May 16, at 10:30am
Title:
VLU wound bed preparation is highly correlated with wound closure
Presenter:
Marissa Carter, MA, PhD
2024 Symposium on Advanced Wound Care (SAWC), Orlando, Florida
Time:
May 17, at 7:30am
Location:
SAWC Innovation Theater
Title:
EscharEx, an innovative multimodal enzymatic debridement agent for the treatment of chronic wounds
Presenters:
Vickie R. Driver, DPM, MS, FACFAS, John C. Lantis, MD, Cyaandi R. Dove, DPM, and Robert J. Snyder, DPM, will discuss the importance of wound bed preparation in wound healing, EscharEx’s mechanism of action, results from the ChronEx Phase II study including case studies showcasing the treatment experience, and the design of the upcoming Phase III study in venous leg ulcers (VLU)
Long-term Complete Response to Can-Fite's Namodenoson in Patient with Advanced Liver Cancer: Article Published in a Leading Scientific Journal
https://finance.yahoo.com/news/long-term-complete-response-fites-110000020.html
PETACH TIKVA, Israel, April 25, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it published an article in the Experimental and Therapeutic Medicine Journal, titled "Long-term complete response to namodenoson in liver cancer with Child-Pugh B cirrhosis: A case report" (Link). The patient participated in the Phase II Liver Cancer Study and has been treated with namodenoson for >7 years under compassionate use program.
The article describes a patient with advanced liver cancer that was enrolled in the former Can-Fite Phase II study, continues to receive treatment with namodenoson, and has now an overall survival of >7 years, with disappearance of ascites, normal liver function, good quality of life and defined as a long term complete response.
Liver Cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.
Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US in which = Namodenoson is being evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective. The study design includes a pre-planned interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients.
Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.
"There is a market need for a safe and effective treatment of patients with advanced liver disease, defined as CPB7 where we believe Namodenoson has an advantage with its anti-cancer and liver protective effect. The complete response of this patient is a testimony for the potential efficacy of Namodenoson and we are optimistic that more patients in the current Phase III study will respond in a similar way," stated Can-Fite CEO Motti Farbstein.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.
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.
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.
Too bad the entire market does
not appreciate PLURI's potential.
I thought i was the only one who
does not!
4.8420-0.2080 (-4.1188%)
As of 10:29AM EDT. Market open.
One day we shall be pleasantly surprised
and handsomely rewarded.
IMO.
BioLineRx Announces Poster Presentation on Apheresis Center Efficiency and CXCR4 Antagonists including APHEXDA® (motixafortide) in Patients with Multiple Myeloma at the ASFA 2024 Annual Meeting
https://finance.yahoo.com/news/biolinerx-announces-poster-presentation-apheresis-110000617.html
TEL AVIV, Israel, April 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma. The poster will be presented at the American Society for Apheresis (ASFA) 2024 Annual Meeting, taking place April 17-19, 2024, in Las Vegas, Nevada.
Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3
The model in the poster at ASFA analyzed the number of apheresis days needed to collect ≥6 million CD34+ cells/kg using different mobilization regimens based on product-specific Phase 3 studies. A direct comparison was used between daily filgrastim alone and in combination with APHEXDA based on the Phase 3 GENESIS trial that supported the U.S. Food and Drug Administration (FDA) approval of APHEXDA. In the absence of head-to-head Phase 3 studies, an indirect comparison was made between daily filgrastim, plerixafor in combination with filgrastim, and APHEXDA in combination with filgrastim. The calculations were based on data from the MOZOBIL® (plerixafor) US Prescribing Information and local laboratory assessments in the GENESIS trial.4
"Variability in the time to mobilize sufficient stem cells for ASCT is a significant operational challenge for apheresis centers that can cause suboptimal experiences for patients, as well as delays in care and cost impact," said Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University. "Research of this type supports clinical and institutional decision making and we look forward to presenting the model at the poster session at ASFA."
Poster Presentation at the ASFA 2024 Annual Meeting
The Resorts World, Las Vegas, NV
Poster Session Details
Poster: Number P-28. See abstract in Journal of Clinical Apheresis.
Title: Enhancing Apheresis Center Efficiency with CXCR4 Antagonists: Evidence from the Phase 3 Trials
Authors: Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA
Date: April 17-19, 2024
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session. The study showed that APHEXDA combined with filgrastim (G-CSF) significantly enhanced the rate of mobilizing ≥6 × 106 CD34+ cells/kg in up to 2 apheresis days compared to placebo + filgrastim. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions.
About APHEXDA®
APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.6
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
WARNINGS AND PRECAUTIONS
Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.
Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.
Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.
Please see the accompanying full Prescribing Information.
18.28 +2.28 (+14.25%)
At close: April 16 at 4:00 PM EDT
18.83 +0.55 (+3.01%)
After hours: 7:53 PM EDT
Volume 223,344
Avg. Volume 70,275
WoW!
Sad, very sad.
Can-Fite: Scientific Article Published by KOL Presents Namodenoson as a Promising Drug Candidate to Treat Advanced Liver Cancer and MASH
https://finance.yahoo.com/news/fite-scientific-article-published-kol-110000491.html
A pivotal Phase III trial for advanced liver cancer, approved by FDA & EMA and a MASH Phase IIb are enrolling patients
PETACH TIKVA, Israel, April 15, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that Biomedicines published an article titled "Namodenoson at the Crossroad of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Hepatocellular Carcinoma (HCC)". Biomedicines is a highly reputable journal that publishes articles on clinical and basic science topics in medicine. https://www.mdpi.com/2227-9059/12/4/848.
The article’s first author, Dr. Ohad Etzion, is a renowned key opinion leader (KOL) in the Hepatology field and is the engine for some of the novel drugs under development for the treatment of MASH and additional liver diseases. Dr. Etzion is the Head, Department of Gastroenterology and Liver Diseases, at Soroka University Medical Center, Beer Sheva, Israel.
The Biomedicines article presents the pre-clinical and clinical activity of Namodenoson and the mechanism of action through which the drug induces the anti-cancer activity and at the same time the liver protective effects. This dual activity enables the drug to have positive effects in both liver cancer and MASH.
Currently, Namodenoson is being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.
"We are very much encouraged by the clinical data from the Phase II study in HCC and the Phase IIa study in MASH. The drug mechanism of action which is presented in the manuscript and entails inflammatory cytokine inhibition together with the stimulation of positive cytokines, position Namodenoson as a promising safe drug," stated Dr. Etzion.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Markets down - BLRX down
Markets up - BLRX down.
No drip drip, free fall.
Biomica to Present at Digestive Disease Week (DDW) Conference 2024 Annual Meeting
https://finance.yahoo.com/news/biomica-present-digestive-disease-week-110000094.html
REHOVOT, Israel, April 11, 2024 /PRNewswire/ -- Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), today announced that it will present results from pre-clinical studies in its irritable bowel syndrome (IBS) program at the Digestive Disease Week (DDW) 2024 Annual Meeting. The conference is being held in Washington, D.C., May 18-21, 2024.
The pre-clinical work was led by Prof. Yehuda Ringel, Biomica's Co-Founder and CSO, in collaboration with the lab of Prof. Kara Gross Margolis, at the NYU Grossman School of Medicine. In the studies, Biomica tested two candidate therapeutic consortia of live bacterial strains, BMC426 and BMC427. Treatment with these drug candidates effectively reduced visceral pain, a major symptom of IBS.
Presentation Details:
Session Type: Research Forum
Session Title: Gut Instincts: Exploring the Interplay of the Microbiome and Gut-Brain Axis
Session Date & Time: May 18, 2024, from 8:00 AM to 9:30 AM EDT
Presentation Title: Pain-reduction effect of a rationally-designed live bacterial consortium for treatment of IBS based on microbiome functional genomics analysis
Prof. Ringel, Biomica's Co-Founder and CSO, stated: "These pre-clinical studies validate the findings of meticulous discovery research based on high-quality human data collected prospectively from patients with functional bowel disorders at the University of North Carolina (UNC) at Chapel Hill. These exciting proof of concept results pave the way for further development of our LBPs as an effective treatment for abdominal pain in patients with IBS and other painful gastrointestinal conditions".
Prof. Ringel will attend the DDW conference and will be available for in-person meetings, and those interested should be in touch with Professor Ringel and / or with the investor or public relations team.
About Biomica's IBS therapeutic candidates: BMC426 and BMC427
BMC426 and BMC427, which are Live Bacterial Products (LBPs), are rationally designed consortia designed to restore specific functionality to a microbial community with individually selected, cultured bacteria. BMC426 and BMC427 are comprised of bacterial strains selected for their multiple desired functions to achieve maximal functional activity with only 4 or 5 bacterial strains, respectively. These LBP's are aimed to result in robust metabolic, physiologic, and immune modulation, and affect IBS through several underlying and complementary modes of action.
About Biomica Ltd.:
Biomica is a clinical stage biopharmaceutical company developing innovative microbiome-based therapeutics utilizing PRISM system, a proprietary computational platform powered by Evogene's MicroBoost AI tech-engine. licensed from Evogene. Biomica aims to identify and characterize disease-related microbiome entities and to develop novel therapeutics based on these understandings. The company is focused on the development of therapies for antibiotic resistant bacteria, immuno-oncology, and microbiome-related gastrointestinal (GI) disorders. Biomica is a subsidiary of Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN).
For more information, please visit www.biomicamed.com
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and virtual meeting from May 18-2, 2024. The meeting showcases more than 4,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
About Evogene Ltd.:
Evogene (Nasdaq: EVGN, TASE: EVGN) is a computational biology company aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost. Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI, and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI).
Evogene uses its tech-engines to develop products through subsidiaries and strategic partnerships. Evogene's subsidiaries currently utilize the tech-engines to develop human microbiome-based therapeutics by Biomica, ag-biologicals by Lavie Bio, ag-chemicals by AgPlenus, medical cannabis products by Canonic and castor varieties, for the biofuel and other industries, by Casterra.
For more information, please visit www.evogene.com.
Forward-Looking Statements:
This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "will", "may", "could", "expects", "intends", "anticipates", "plans", "believes", "scheduled", "estimates", "demonstrates", or words of similar meaning. For example, Evogene and Biomica are using forward-looking statements in this press release when they discuss Biomica's product candidates potentially resulting in robust metabolic, physiologic and immune modulation, and affecting IBS through several underlying and complementary modes of action, as well as an effective treatment for abdominal pain in patients with IBS and other painful gastrointestinal conditions. Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, and involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, the current war between Israel and Hamas and any worsening of the situation in Israel such as further mobilizations or escalation in the northern border of Israel and those risk factors contained in Evogene's reports filed with applicable securities authorities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections, and assumptions.
Contacts
Rachel Pomerantz Gerber
Head of Investor Relations at Evogene
rachel.pomerantz@evogene.com
Tel: +972-8-9311901
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View original content:https://www.prnewswire.com/news-releases/biomica-to-present-at-digestive-disease-week-ddw-conference-2024-annual-meeting-302114274.html
SOURCE Biomica Ltd.
A pleasant & surprising closing:
0.7357+0.0282 (+3.9859%)
At close: 04:00PM EDT
Volume 1,388,097
Avg. Volume 388,562
With robust volume. Nice.
0.6600-0.0475 (-6.6230%)
As of 10:25AM EDT. Market open.
Small wonder market reaction to the PR
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.
I would be a whole lot happier if BLRX
had announced:
BioLineRx Accesses Second Tranche of $20 Million Under Previously Announced $40 Million Non-Dilutive Debt Financing Agreement
https://finance.yahoo.com/news/biolinerx-accesses-second-tranche-20-110000620.html
- Proceeds to be used to further accelerate uptake of APHEXDA® in stem cell mobilization, life-cycle expansion activities in sickle cell disease, and motixafortide metastatic pancreatic cancer program -
TEL AVIV, Israel, April 10, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has drawn-down the second tranche of $20 million under its previously announced $40 million non-dilutive debt financing agreement with funds and accounts managed by BlackRock.
The agreement with BlackRock EMEA Venture and Growth Lending (previously Kreos Capital) was originally announced in September 2022.
"We are very pleased to be able to access this second tranche of non-dilutive funding at terms that we believe are very favorable to our company," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These funds should allow us to meaningfully advance the commercialization of APHEXDA® in stem cell mobilization for multiple myeloma, accelerate APHEXDA life-cycle programs in sickle cell disease and other areas, and support development of motixafortide in metastatic pancreatic cancer."
Per the terms of the original agreement, the first tranche of $10 million was made available to BioLineRx upon execution of the definitive agreement. The remaining $30 million was made available in two additional tranches of $20 million and $10 million, respectively, subject to the achievement of pre-specified milestones. The remaining tranche of $10 million may be available for drawdown through October 1, 2024.
Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. Borrowings under the financing bear interest at a fixed rate of 9.5% per annum (~11.0%, including associated cash fees). In addition, funds and accounts managed by BlackRock are entitled to mid-to-high single-digit royalties on APHEXDA (motixafortide) sales, up to a pre-defined cap. No warrants were issued by BioLineRx in connection with this financing.
As of December 31, 2023, BioLineRx reported cash, cash equivalents, and short-term bank deposits of $43.0 million. In addition to the $20 million drawdown of the loan tranche reported herein, the company recently completed a registered direct equity offering which raised an additional $6 million.
Upcoming milestones:
Concurrent with this announcement, BioLineRx today also reiterated its expected upcoming milestones:
Continued commercial ramp-up of APHEXDA in the US
Commercial expansion in Asia with collaboration partner Gloria BioSciences
Initiation of bridging study by Gloria Biosciences in the second half of this year to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China
Completion of recruitment in the Phase 1 pilot study of motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine, with initial data expected in the second half of this year
Continued recruitment in the Chemo4MetPanc Phase 2b randomized clinical trial in first-line metastatic pancreatic cancer sponsored by Columbia University
Preparation activities with Gloria Biosciences on a randomized Phase 2b clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care chemotherapy in first-line pancreatic cancer
I should do so.
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.
It seems that indeed BLRX is walking
on the footsteps of GMDA.
Very warm market reaction towards the news!
0.8345+0.0906 (+12.1791%)
As of 01:19PM EDT. Market open.
Volume 180,055
Avg. Volume 174,631
What's up?
And with it you also have no business!
5.29-0.13 (-2.40%)
As of 01:25PM EDT. Market open.
Volume 571,492
Avg. Volume 17,671
When will you learn, a patent is only worthwhile
if and when someone pays you to make use of it.
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.
After 3 consecutive r/s i wonder how much
wisdom i can achieve from a dry prune that
you are!
A patent is only a patent.
I wager besides the immediate frenzy,
stock will end at no more than +5% from
closing day Friday!
COLLPLANT BIOTECHNOLOGIES REPORTS 2023 FULL YEAR FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
https://finance.yahoo.com/news/collplant-biotechnologies-reports-2023-full-110000475.html
Regenerative breast implant program large-animal study underway to evaluate commercial-size implants with topline data expected in Q4
Ends 2023 with $26.7 million in cash and cash equivalents
Conference call to be held on Thursday, April 4, 2024 at 10:00 a.m. U.S. EDT
REHOVOT, Israel, April 4, 2024 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and organ manufacturing, today announced financial results for the full year ended December 31, 2023 and provided a corporate update.
"During 2023, the end of which became a challenging year for our nation, we excelled in the advancement of our key programs," said CollPlant's Chief Executive Officer, Yehiel Tal. "We leveraged our pioneering collagen technology platform and dynamic workforce to strengthen existing business collaborations, and advanced our programs - notably with partner, AbbVie. We progressed the dermal filler candidate, which is now in clinical development, and formed a collaboration with industrial 3D printing leader, Stratasys, to refine the manufacturing scale for our breast implants program. Related to our dermal filler partnership with AbbVie, we achieved an important milestone triggering a $10 million milestone payment that we realized in June 2023."
Mr. Tal continued, "As we begin 2024, we believe we are poised to take advantage of the aesthetic and regenerative market this year with a strong balance sheet, lean operating structure, and support from our partners."
2023 and Recent Corporate Highlights
Collaboration Updates
During 2023, CollPlant made significant progress with its development partner, AbbVie, to advance the dermal and soft tissue filler program toward commercialization.
In June 2023, CollPlant announced the achievement of an important milestone under the AbbVie collaboration which triggered a $10 million payment from AbbVie to CollPlant. Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option product payments, as well as meaningful royalties on product sales.
In April 2023, CollPlant announced a joint development and commercialization agreement with Stratasys Ltd. to collaborate on the development of a solution to bio-fabricate human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rhCollagen-based bioinks. The first project under the agreement focuses on the development of a bioprinter specific to the creation of CollPlant's regenerative breast implants. It is meant to be an industrial-scale production solution for CollPlant's regenerative breast implants program. CollPlant's state-of-the-art breast implants are being developed to regenerate an individual's natural breast tissue without eliciting immune response, providing a potentially revolutionary alternative for both aesthetic and reconstructive procedures. Under the agreement, both companies have agreed to cross-promote each other's bioprinting products.
CollPlant remains engaged in partnering discussions with several industry leaders in order to leverage its rhCollagen technology and expertise in 3D bioprinting with the mission to develop novel regenerative medical and aesthetics solutions and related applications.
Regenerative Breast Implants
Our regenerative breast implants are targeting the $2.9 billion global breast implant market. The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.
Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
In addition, CollPlant's regenerative breast implants can be a novel solution for women in the breast reconstruction and augmentation market, which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today.
In January 2023, CollPlant announced the successful completion of a large-animal study for its regenerative breast implants. This preclinical study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported. This study was followed by additional large-animal studies that were intended to further optimize the implant design and composition. New tissue formation and neovascularization with no adverse tissue reactions were demonstrated confirming previous results.
In December of 2023, CollPlant initiated a large-animal study to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data that will be used to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study in the fourth quarter of this year.
Intellectual Property
In November 2023, CollPlant announced that the U.S. Patent and Trademark Office granted the Company a patent that relates to its photocuring technology and serves as the basis of its photocurable dermal filler product candidate, being developed for the aesthetics market.
In addition, in March 2024, the same patent application received allowance in Brazil. Patents were also granted in Israel and Australia allowing for protection until 2039 in these regions.
This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets.
Gut-on-a-Chip Tissue Model
Given CollPlant's focus on the medical aesthetics area and its collaboration with AbbVie, it has decided to place its resources on hold directed toward its gut-on-a-chip program for the treatment of ulcerative colitis. The Company highly values this program, and the rationale for this relates to the extensive projected timing to progress the tissue model as it relates to cell collection, as well as other processes that must first be conducted before even beginning testing. Therefore, in line with prioritizing its resources, CollPlant expects to reinitiate this program once its resources are commensurate with the projected timing of this program.
Corporate Governance
In the second quarter of 2023, CollPlant announced that it hired a dedicated expert to lead its Environment, Social and Governance (ESG) effort. CollPlant plans to file its first ESG report in the second quarter which will outline its ESG objectives.
In September 2023, CollPlant announced that it joined the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. As a new participant of this voluntary leadership platform, CollPlant strengthens its commitment to operate sustainably.
Year-Ended December 31, 2023 Financial Results
GAAP revenues for the year ended December 31, 2023, were $11.0 million and included mainly revenues from AbbVie, CollPlant's business partner. Revenues increased by $10.7 million, compared to $299,000 for the year ended December 31, 2022. The increase is mainly related to the achievement of a milestone under the AbbVie Agreement, which triggered a $10.0 million payment and a $600,000 increase in sales of rhCollagen products.
GAAP cost of revenues for the year ended December 31, 2023, was $2.0 million, compared to $400,000 for the year ended December 31, 2022. The increase in cost of revenues by approximately $1.6 million is mainly due to: (i) approximately $320,000 in royalty expenses to the IIA, mainly relating to the milestone achievement under the AbbVie Agreement, (ii) approximately $711,000 related to bioinks, VergenixFG, and rhCollagen sales, and (iii) approximately $570,000 related to inventory write offs.
GAAP gross profit for the year ended December 31, 2023, was $9.0 million, compared to gross loss of $101,000 for the year ended December 31, 2022.
GAAP operating expenses for the year ended December 31, 2023, were $16.5 million, compared to $17.0 million, for the year ended December 31, 2022. The decrease of $500,000 is mainly attributed to a decrease of $745,000 in general and administrative expenses, mainly comprised of: (i) a decrease of $224,000 in employees' salaries expense, (ii) a decrease of $364,000 in share-based compensation expenses and (iii) income of $140,000 for insurance indemnification, offset by an increase of $229,000 in research and development expenses. On a non-GAAP basis, the operating expenses for the year ended December 31, 2023 were $14.5 million, compared to $15.2 million in the year ended December 31, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the year ended December 31, 2023, totaled $493,000, compared to $172,000 in the year ended December 31, 2022. The increase in financial income, net, is due to the increase in interest rates and interest received from the Company's short-term cash deposits.
GAAP net loss for the year ended December 31, 2023 was $7.0 million, or $0.62 basic loss per share, compared to a net loss of $16.9 million, or $1.53 basic loss per share, for the year ended December 31, 2022. Non-GAAP net loss for the year ended December 31, 2023, was $5.2 million, or $0.46 basic loss per share, compared to $15.2 million loss, or $1.37 basic loss per share, for the year ended December 31, 2022.
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of December 31, 2023, was $26.7 million.
Cash used in operating activities was $2.8 million during the year ended December 31, 2023, compared to $13.7 million for the year ended December 31, 2022. Cash used during the year ended December 31, 2023 includes the $10 million milestone payment from AbbVie.
Net cash used in investing activities was $1.2 million during the year ended December 31, 2023 compared to $28.9 million in net cash that was provided by investing activities during the year ended December 31, 2022. The decrease is mainly attributed to repayment and investment in short-term cash deposits during the year ended December 31, 2022.
Cash provided by financing activities was $1.1 million for the year ended December 31, 2023 compared to $1.9 million in the year ended December 31, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of warrants and options into shares.
Conference call information
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13744114
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Webcast information
A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time.
Submit questions to management in advance of the call and webcast
To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at daniel@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
26,674
$
29,653
Restricted deposit
241
23
Trade receivables, net
-
9
Other accounts receivable and prepaid expenses
393
543
Inventories
714
1,430
Total current assets
28,022
31,658
Non-current assets:
Restricted deposit
57
188
Operating lease right-of-use assets
3,070
2,711
Property and equipment, net
2,789
2,966
Intangible assets, net
188
245
Total non-current assets
6,104
6,110
Total assets
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
December 31,
2023
2022
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$
980
$
1,133
Operating lease liabilities
624
529
Accrued liabilities and other payables
1,647
1,443
Total current liabilities
3,251
3,105
Non-current liabilities:
Operating lease liabilities
2,535
2,382
Total non-current liabilities
2,535
2,382
Total liabilities
5,786
5,487
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares
as of December 31, 2023 and , 2022; issued and outstanding: 11,452,672
and 11,186,481 ordinary shares as of December 31, 2023 and 2022,
respectively
4,982
4,873
Additional paid in capital
121,068
118,099
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(96,741)
(89,722)
Total shareholders' equity
28,340
32,281
Total liabilities and shareholders' equity
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended December 31,
2023
2022
2021
Revenues
$
10,959
$
299
$
15,641
Cost of revenues
1,991
400
2,005
Gross profit (loss)
8,968
(101)
13,636
Operating expenses:
Research and development
10,484
10,255
7,631
General, administrative and marketing
5,996
6,741
5,940
Total operating income (loss)
(7,512)
(17,097)
65
Financial income, net
493
172
172
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Basic net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Diluted net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Weighted average number of ordinary shares used in
computation of basic net income (loss) per share
11,389,168
11,033,310
9,968,972
Weighted average number of ordinary shares used in
computation of diluted net income (loss) per share
11,389,168
11,033,310
11,966,788
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Loss on sale of property and equipment
18
-
-
Depreciation and amortization
1,102
1,076
773
Accrued interest
(28)
(87)
(151)
Share-based compensation to employees and consultants
1,937
2,174
1,597
Exchange differences on cash and cash equivalents
379
608
(143)
Remeasurement of Derivatives liability
-
-
(28)
Changes in assets and liabilities:
Decrease in trade receivables
9
261
560
Decrease (increase) in inventories
749
(312)
181
Decrease (increase) in other receivables and prepaid expenses
150
(119)
(185)
Decrease in operating lease right-of-use assets
527
461
400
Increase (decrease) in trade payables
(153)
99
236
Decrease in operating lease liabilities
(638)
(916)
(337)
Increase (decrease) in accrued liabilities and other payables
204
14
(464)
Decrease in deferred revenues
-
(32)
(175)
Net cash provided by (used in) operating activities
(2,763)
(13,698)
2,501
Cash flows from investing activities:
Capitalization of intangible assets
-
(42)
(161)
Purchase of property and equipment
(954)
(1,274)
(1,428)
Proceed from short term deposit
-
50,238
-
Investment in restricted deposits
(270)
-
-
Investment in deposits
-
(20,000)
(30,000)
Proceeds from sale of property and equipment
68
-
33
Net cash provided by (used in) investing activities
(1,156)
28,922
(31,556)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
-
-
32,743
Exercise of options and warrants into shares
1,108
1,874
6,017
Net cash provided by financing activities
1,108
1,874
38,760
Effect of exchange rate changes on cash and cash equivalents and restricted deposits
(379)
(608)
143
Net increase (decrease) in cash and cash equivalents and restricted deposits
(3,190)
16,490
9,848
Cash and cash equivalents and restricted cash at the beginning of the year
29,864
13,374
3,526
Cash and cash equivalents and restricted deposits at the end of the year
$
26,674
$
29,864
$
13,374
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Supplemental discloser of non-cash activities:
Right of use assets recognized with corresponding lease liabilities
$
886
$
219
$
557
Classification of issuance costs liability to equity
$
-
$
-
$
50
Capitalization of Share-based compensation to inventory
$
33
$
37
$
-
Supplemental discloser of cash activities:
Cash paid during the year for taxes
$
8
$
31
$
-
Reconciliation of cash, cash equivalents and restricted cash at the end of the year
Cash and cash equivalents
$
26,674
$
29,653
$
13,148
Restricted deposits short term
-
23
13
Restricted deposits long term
-
188
213
Total cash and cash equivalents and restricted deposits
$
26,674
$
29,864
$
13,374
CollPlant Biotechnologies Ltd.
Reconciliation of GAAP to Non-GAAP Financial Measures
(U.S. dollars in thousands, except per share data)
Year ended December 31,
2023
2022
GAAP operating expenses:
$
16,480
$
16,996
Change of operating lease accounts
-
455
Share-based compensation to employees, directors and consultants
(1,937)
(2,211)
Non-GAAP operating expenses:
14,543
15,240
GAAP operating loss
(7,512)
(17,097)
Change of operating lease accounts
-
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP operating loss
(5,575)
(15,341)
GAAP Net loss
(7,019)
(16,925)
Change of operating lease accounts
(111)
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP Net loss
$
(5,193)
$
(15,169)
GAAP basic and diluted loss per ordinary share
$
(0.62)
$
(1.53)
NON- GAAP basic and diluted loss per ordinary share
$
(0.46)
$
(1.37)
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com.
Use of Non-US GAAP ("non-GAAP")
Financial results for 2023 and 2022 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results.
The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" later in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
The Company's consolidated financial statements for the year ended December 31, 2023, are presented in accordance with generally accepted accounting principles in the U.S.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at www.sec.gov and posted on the Company's investor relations website at http://ir.collplant.com/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone at +972-73-232 5600.