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BioLineRx Launches 'Mobilization Matters': A Digital Resource for People with Multiple Myeloma Preparing for Stem Cell Collection
https://finance.yahoo.com/news/biolinerx-launches-mobilization-matters-digital-170100432.html
Patient survey currently underway in partnership with the HealthTree Foundation; data expected in Q1 2025
TEL AVIV, Israel and WALTHAM, Mass., Sept. 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 the launch of Mobilization Matters, a digital resource for people with multiple myeloma who are preparing for stem cell collection for an autologous stem cell transplant. Launched on Apheresis Awareness Day, this platform offers patient stories, educational resources, and more to support those undergoing this critical phase of treatment.
In conjunction with this launch, BioLineRx is partnering with the HealthTree Foundation to conduct the Mobilization Matters Stem Cell Collection Survey. This initiative aims to gather insights from patients about their experiences with stem cell collection and apheresis as part of their multiple myeloma journey. The findings will help illuminate patient experiences, enhance understanding, and improve care and support strategies. Survey results are expected in Q1 2025.
"We are deeply committed to supporting multiple myeloma patients and their care partner through their stem cell collection process," said Holly May, MBA, President of BioLineRx USA. "Our goal is to enrich education and foster dialogue, empowering patients with knowledge. Mobilization Matters is designed to achieve this by amplifying patient voices and providing comprehensive resources."
In addition to patient stories and survey information, Mobilization Matters features a discussion guide to facilitate conversations between patients and their healthcare teams before apheresis. For more information, visit www.mobilizationmatters.com.
AbouAt the Mobilization Matters Survey
The Mobilization Matters Stem Cell Collection Survey is being conducted by the HealthTree Foundation on behalf of BioLineRx among adults with multiple myeloma (ages 18+) who have attempted stem cell collection for a planned transplant. Developed in collaboration with experts from leading institutions and patient advisors, the survey aims to provide valuable insights into the emotional, physical, and daily life challenges patients face during the stem cell collection process. Results will be shared on mobilizationmatters.com, once available.
"This survey will provide important insights into the patient experience with stem cell collection, offering a deeper understanding of the potential challenges involved," said Beth B. Giblin, PharmD, Head of US Medical Affairs, BioLineRx. "Our aim is to use the findings to build on the existing literature and inform data-driven approaches to patient care and support."
"We need to better understand the patient's journey during the stem cell collection process," said Jenny Ahlstrom, Founder & CEO of the HealthTree Foundation. "We are excited to use these data to advance education and drive patient-centered care. This collaboration supports our mission to empower multiple myeloma patients with knowledge, enhance their care experiences, and contribute meaningfully to research."
This survey marks the first patient experience study by the HealthTree Foundation on this critical topic. The research is being conducted through the HealthTree Cure Hub, a patient-data platform and community with over 14,000 registered myeloma patients, where participants can opt into surveys and studies to accelerate research and shape the future of healthcare.
About Stem Cell Mobilization for Multiple Myeloma
Autologous stem cell transplantation (ASCT) is the preferred first-line treatment for multiple myeloma – the second most common blood cancer – and is integral to the prospect of improving survival and helping to restore the immune system.i,ii
Prior to ASCT, patients undergo apheresis, a procedure to collect stem cells for transplant. Stem cells are made deep in the bone marrow and need to be mobilized from the bone marrow to the bloodstream for collection during apheresis.iii,iv
ASCT success depends on adequate mobilization and collection of stem cells.iii While more multiple myeloma patients are candidates for ASCT than ever before, stem cell mobilization and collection is a growing challenge. This is due to factors such as increasing proportion of older patients receiving ASCTvi and the use of standard 3- and 4-drug induction therapy, which can further impair mobilization with fewer cells mobilized and additional days of apheresis required.vii, viii
About the HealthTree Foundation
HealthTree is a global nonprofit using innovation to save lives. They provide lifetime personalized support and education, meaningful patient-to-patient connections and a powerful patient data portal. HealthTree's cutting-edge technology empowers patients to better manage their health and engages them as critical contributors to lifesaving research. The trust of their patient community allows HealthTree to provide continually updated, real-world patient data to researchers who seek to advance clinical care and find cures for blood cancers. Visit healthtree.org today.
Study Published in the British Journal of Radiology Demonstrates IceCure's ProSense® is a Safe Procedure with 97.7% Technical Success Rate in Treating Tumors of the Lung, Bone, and Soft Tissues
https://finance.yahoo.com/news/study-published-british-journal-radiology-120000504.html
Liquid nitrogen- (LN2) based ProSense® found to have favorable safety compared to argon-based cryoablation systems, as well as being more cost effective and easier to manage
Independent study conducted at the European Institute of Oncology (IEO) demonstrates interventional radiology use cases for ProSense® for indications that are approved in various markets across the world
CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an independent study led by Dr. Franco Orsi, Director of Interventional Radiology at the European Institute of Oncology (IEO) in Milan, Italy and an expert ProSense® user. The study titled "Liquid Nitrogen-Based Cryoablation: Complication Rates for Lung, Bone, and Soft Tissue Tumors" was published by Oxford University Press on behalf of the British Institute of Radiology.
"Cryoablation with liquid nitrogen has a growing role in early oncology treatments across a wide variety of cancer types and particularly for patients who may have multiple comorbidities and/or who want to avoid surgery. As interventional radiologists are increasingly and effectively using cryoablation, it's important to note Dr. Orsi and his colleagues underscore in the paper that interventional radiology is now the fourth pillar of the oncology field, alongside clinical oncology, surgical oncology and radiation therapy," stated IceCure's Chief Executive Officer, Eyal Shamir. "We are very pleased that ProSense® is providing a minimally invasive option to treat cancer patients early, safely and effectively."
The study assessed the complication rate both during and 24 hours after treatment with IceCure's cryoablation system in 85 patients who were treated for 96 lesions (tumors), 36.4% of which were lesions in bones, 18.8% in lungs, and 44.8% in soft tissue. The primary technical success rate, defined as complete tumor coverage, was 97.7% (83 of 85 patients). Patients with benign and malignant tumors were treated for either curative or palliative intent. Minor complications resolved themselves without intervention or merely required simple interventions such as drainage. The study concluded that cryoablation using an LN2-based system, such as ProSense®, is safe across various tumor sizes and locations, with only minor complications observed.
LN2-based cryoablation was compared to argon-based systems in the study who point to the benefits of LN2 procedures including its suitability for office-based procedures performed under local anesthesia, compared to argon systems which typically require general anesthesia and are therefore less suitable for office procedures. The study also addresses the challenges of argon systems requiring large argon gas cylinders, which necessitate dedicated storage space and trained personnel for transport, as well as the higher cost of the procedure due to the use of multiple cryoprobes as well as the use of noble gases, argon and helium. The study demonstrates that LN2-based systems, such as ProSense®, are more cost effective and easier to manage.
Two previously published independent lung cancer studies of ProSense® in the treatment of lung cancer, which evaluated the procedure's local control and recurrence free rate, reported 96% and 100% three-year recurrence free rates. Independent and IceCure-sponsored studies of other interventional radiology indications are ongoing.
Can-Fite: Pancreatic Carcinoma Phase IIa Clinical Study with Namodenoson Received Regulatory Authorization from the Israeli Ministry of Health
https://finance.yahoo.com/news/fite-pancreatic-carcinoma-phase-iia-110000138.html
Study will aim to establish safety and clinical efficacy
PETACH TIKVA, Israel, Sept. 16, 2024 (GLOBE NEWSWIRE) -- 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 it received approval from the Israeli Ministry of Health (MoH) to conduct Phase IIa clinical trial with orally-administered Namodenoson in the treatment of pancreatic carcinoma.
“We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of namodenoson and definitive molecular mechanism of action against pancreatic carcinoma,” stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. “We are very keen to initiate the study in this devastating disease and are pleased with the regulatory approval of the Israeli MOH. We do hope that as we have shown efficacy in patients with advanced liver cancer studies, we will be able to demonstrate safety and efficacy in the pancreatic cancer patient population.”
The Phase IIa is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients will receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).
The study will be conducted by Dr. Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US.
IceCure Announces FDA Advisory Panel Meeting Date for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer Scheduled for November 7, 2024
https://finance.yahoo.com/news/icecure-announces-fda-advisory-panel-120000234.html
Public forum to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for an estimated 70,000 women diagnosed in U.S. annually with early-stage low risk breast cancer
FDA decision regarding marketing authorization of ProSense® expected by early 2025
CAESAREA, Israel, Sept. 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.
"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense® as an alternative to surgery," stated IceCure's CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense® by early 2025."
The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense® as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company's ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.
The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
12.49 +2.19 (+21.32%)
As of 2:26 PM EDT. Market Open.
Going Places!
Hopefully Talicia sales will increase as a
result of todays PR.
RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines
https://finance.yahoo.com/news/redhills-talicia-listed-first-line-110000435.html
First new American College of Gastroenterology (ACG) Clinical Guideline[1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option
Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing
Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for H. pylori infection, which affects approximately 35% of the U.S. adult population[3]
Worldwide, around 66% of the population has H. pylori infection[4], which is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer[5] and a major risk factor for peptic ulcer disease[6]
RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the placement of low-dose rifabutin-triple therapy, Talicia, as an empirically-prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection in the newly published American College of Gastroenterology (ACG) Clinical Guideline: Treatment of H. pylori Infection, previously updated in 2017.
"The ACG Clinical Guideline is clear that clarithromycin-based triple therapy is no longer a reliable first-line option for the treatment of H. pylori infection, unless prior resistance testing has shown clarithromycin susceptibility. Resistance rates to both of the antibiotics contained in Talicia, amoxicillin and rifabutin, are minimal - <3.0% and <1.0%, respectively[7] - supporting Talicia as a rational empirically-prescribed first-line option," Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Talicia's all-in-one formulation and flexible dosing schedule – three times daily (TID), at least four hours apart with food, for 14 days – offers a simplified patient experience, supporting high rates of eradication without the requirement of prior resistance testing."
It has been almost eight years since the ACG Clinical Guideline's last update, which was prior to the launch of Talicia. "The newly updated ACG Clinical Guideline confirms the use of Talicia as a first-line option," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "Healthcare providers can be confident in their choice of Talicia without the requirement of prior resistance testing, and we trust that this newly updated ACG Clinical Guideline will continue to change the status quo of H. pylori treatment to further improve patient outcomes."
RedHill Biopharma Regains Compliance with Nasdaq Minimum Bid Price Requirement
https://finance.yahoo.com/news/redhill-biopharma-regains-compliance-nasdaq-110000778.html
TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received confirmation from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the "Listings Qualifications Department") that the Company had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market ("Nasdaq"), and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with Nasdaq Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price for its American Depositary Shares (the "ADSs") of $1.00 per share or more for at least 10 consecutive business days, which was achieved on September 3, 2024.
Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it has repaid in full all of the outstanding principal and interest payable under its 7.50% Senior Secured Convertible Promissory Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.
"Repayment of our convertible notes is a significant milestone for our company as we are now debt-free and have eliminated the potential equity overhang presented by the notes," said Dror Bashan, Protalix's President and Chief Executive Officer. "Over the last decade, our company has been financed in part through the issuance of convertible notes, the total outstanding principal amount of which reached $78.0 million at its highest. Given this repayment, our financial discipline has resulted in a strong balance sheet that is sufficient to support our planned ongoing operations."
https://www.streetinsider.com/Corporate+News/Protalix+BioTherapeutics+%28PLX%29+Repays+Outstanding+Senior+Secured+Convertible+Promissory+Notes/23677145.html
New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality
https://finance.yahoo.com/news/peer-reviewed-publication-opaganib-phase-110000409.html
Data, from a post hoc analysis of the randomized, placebo-controlled, double-blind phase 2/3 study of oral opaganib in COVID-19 pneumonia, showing a 62% reduction in mortality and a 21% improvement in time to room air (no longer needing supplemental oxygen), has been newly published in the peer-reviewed journal, Microorganisms
The analysis, from a large sub-group of 251 hospitalized, moderately severe COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60%, also indicates that FiO2 of greater than 60% may represent a threshold level for disease severity, and may potentially be a patient selection biomarker, an important finding for future therapeutic strategies and studies
With 30,000 Americans dead due to COVID-19 so far this year according to the World health Organization[1], new, effective and safe therapies are still very much needed
With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles in oncology indications, viral infection, nuclear/radioprotection and other inflammatory diseases
TEL AVIV, Israel and RALEIGH, N.C., Sept. 3, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication of data, in the journal Microorganisms[2], from the 57-site, randomized, placebo-controlled, double-blind phase 2/3 study of opaganib[3] in COVID-19 pneumonia (NCT04467840).
The post hoc analysis of data from 251 study participants showed that hospitalized COVID-19 patients requiring a fraction of inspired oxygen (FiO2) up to and including 60% (FiO2≤60%) had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134). There was a clinically meaningful 62% reduction in mortality (5.98% vs. 16.7%; p-value=0.019 (post-hoc)) by day 42. Additionally, the proportion of patients with FiO2≤60% at baseline that no longer required supplemental oxygen (≥24 hours) by day 14 of opaganib treatment increased by 21% (76.9% opaganib vs. 63.4% placebo: p-value =0.033 (post hoc)). The safety profile for opaganib was similar to placebo.
The data also indicated that FiO2 of greater than 60% may represent a threshold level for disease severity which could be utilized as a biomarker, an important finding for future therapeutic strategies.
"The all-consuming COVID-19 state-of emergency may have subsided, but the SARS-CoV-2 virus has not – patients are still contracting COVID-19. 30,000 Americans have died due to COVID-19 so far this year, and many patients are still hospitalized because of it. This remains a patient population for whom there are still very limited treatment options and there remains a substantial need for effective and safe new therapies," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "These published post-hoc study data suggest a distinct treatment benefit in hospitalized COVID-19 patients requiring an FiO2 of ≤60%. This, supported by additional data such as lower inflammatory markers and higher lymphocyte counts, and added to a favorable safety profile, point to the potential of opaganib to be an effective new oral therapy for hospitalized COVID-19 patients, warranting further investigation. Of significant additional interest is the insight that baseline FiO2 requirement may be a new clinical biomarker for patient selection and potentially have a major impact on how hospitalized COVID-19 patients are managed in the future."
I some regained confidence we shall be able
to recoup some of our losses now that RDHL
seems to be on the right tracks.
Time will tell.
RedHill Biopharma Ltd. (NASDAQ:RDHL) Short Interest Down 94.8% in August
https://www.modernreaders.com/news/2024/08/28/redhill-biopharma-ltd-nasdaqrdhl-short-interest-down-94-8-in-august.html
RedHill Biopharma Ltd. (NASDAQ:RDHL – Get Free Report) saw a significant drop in short interest during the month of August. As of August 15th, there was short interest totalling 21,700 shares, a drop of 94.8% from the July 31st total of 417,400 shares. Approximately 1.7% of the shares of the company are short sold. Based on an average daily trading volume, of 304,200 shares, the days-to-cover ratio is presently 0.1 days.
Hedge Funds Weigh In On RedHill Biopharma
A hedge fund recently raised its stake in RedHill Biopharma stock. Gagnon Securities LLC boosted its holdings in shares of RedHill Biopharma Ltd. (NASDAQ:RDHL – Free Report) by 32.1% in the 1st quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission (SEC). The fund owned 118,360 shares of the biotechnology company’s stock after purchasing an additional 28,771 shares during the period. Gagnon Securities LLC owned approximately 0.40% of RedHill Biopharma worth $63,000 at the end of the most recent quarter. Hedge funds and other institutional investors own 7.20% of the company’s stock.
Can-Fite Reports First Half 2024 Financial Results & Progress in Two Pivotal Phase III Clinical Studies
https://finance.yahoo.com/news/fite-reports-first-half-2024-121500188.html
RAMAT GAN, Israel, Aug. 29, 2024 (GLOBE NEWSWIRE) -- 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 financial results and clinical updates for H1 2024.
H1 2024 Highlights
Exercise of Warrants for Approximately $5.0 Million in Gross Proceeds – in August, the Company announced the exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023. In consideration for the immediate exercise of the warrants for cash, the Company issued new unregistered warrants to purchase up to 5,714,286 ADSs.
Piclidenoson Drug Candidate -
Positive Results from an Osteoarthritis clinical study in dogs were reported by Can-Fite’s partner Vetbiolix, who is developing Piclidenoson for veterinary indications. Vetbiolix concluded successfully the study interim analysis and can now exercise an option to enter into a full in license agreement with Can-Fite. Based on the agreement between the two companies, if it exercises the option, Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.
Namodenoson Drug Candidate -
Liver Cancer – the Company’s Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania. In addition, two scientific articles, one describing long-term complete response to Namodenoson in a patient with advanced liver cancer and the other presents Namodenoson as a promising drug candidate to treat advanced liver cancer and MASH, were published.
Pancreatic Cancer – the Company received approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel, for a Phase IIa study for the treatment of pancreatic cancer. The Company awaits now the approval of the Ministry of Health (MOH). In addition, the Company submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for Namodenoson in the treatment of pancreatic carcinoma.
MASH (metabolic dysfunction-associated steatohepatitis) – the FDA granted IND clearance for Namodenoson to treat MASH patients in a Phase IIb study. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA allows for the recruitment of patients in the US.
“With two drugs in advanced clinical studies we continue to enroll patients and push forward towards a positive conclusion of each program. We continue to position our drugs for multi-billion markets with unmet needs,” stated Can-Fite CEO & CFO Motti Farbstein.
Financial Results
Revenues for the six months ended June 30, 2024 were $0.32 million compared to revenues of $0.39 million for the same period in 2023. Revenues for the six months ended June 30, 2024 and June 30, 2023 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.
Research and development expenses for the six months ended June 30, 2024 were $2.89 million compared with $3.42 million for the same period in 2023. Research and development expenses for the first half of 2024 comprised primarily of expenses associated with the two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenoson.
General and administrative expenses were $1.53 million for the six months ended June 30, 2024 compared to $1.47 million for the same period in 2023. The decrease is primarily due to the decrease in our D&O insurance policy and decrease in bonus expenses to employees and executives. We expect that general and administrative expenses will remain at the same level through 2024.
Financial income, net for the six months ended June 30, 2024 was $0.14 million compared to $0.28 million for the same period in 2023. The decrease in financial income, net was mainly due to lower income on short term deposits.
Net loss for the six months ended June 30, 2024 was $3.95 million compared with a net loss of $4.22 million for the same period in 2023. The decrease in net loss for the six months ended June 30, 2024 was primarily attributable to the decrease in our operating expenses.
As of June 30, 2024, Can-Fite had cash and cash equivalents and short term deposits of $4.72 million as compared to $8.90 million at December 31, 2023. The decrease in cash during the six months ended June 30, 2024 is due to the ongoing operations of the Company. On August 8, 2024, the Company and a certain warrant holder entered into an inducement offer letter agreement, according to which the warrant holder agreed to exercise for cash warrants to purchase 2,857,143 ADSs at an exercise price of $1.75 per ADS. Total gross consideration received was $5 million. In addition, as part of the inducement letter and the exercise of warrants, the Company has issued the investor new warrants exercisable into 5,714,286 ADSs at an exercise price of $2.25 per ADS. Moreover, the Company also issued to its placement agent new warrants exercisable into 200,000 ADSs at an exercise price of $2.1875 per ADS.
The Company’s condensed consolidated financial results for the six months ended June 30, 2024 are presented in accordance with US GAAP Reporting Standards.
We shall see if today's optimistically positive
PR of today will finally drive the shorts away!
Sure hope so!
RedHill Biopharma Announces First Half 2024 Business Highlights
Numerous potential catalysts
Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base
U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborations
Addressing substantial and underserved indications: In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetes
Building value: In the lab and in the clinic through new studies, generating new intellectual property and publications and forging the right partnerships for our assets
Streamlined U.S. commercial organization: Cost reduction measures resulted in a much smaller, more efficient and cost-effective organization while still maintaining a leadership position with Talicia®
R&D and Commercial Highlights:
Opaganib:
- U.S. Army program for Ebola (believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease)
- Orphan drug designation granted by FDA for neuroblastoma
- Discussions ongoing for a potential externally-funded, mid-stage clinical study in an additional underserved oncology indication
- U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure
- Positive in vivo study results support potential of opaganib therapy in diabetes / obesity
RHB-107:
- COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment; enrollment estimated to be completed in the first half of 2025
- U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir
RHB-104: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease
Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team:
- Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use
- Potential manufacturing developments aiming to open additional new markets underway
- Commercially launched in the UAE, triggering RedHill's eligibility for potential milestone and royalty payments; Additional ex-US partnerships under discussions
Financial highlights:
Cash balance of $8.2 million as of June 30, 2024[1]; Net revenues for the first half of 2024 totaled $2.6 million. Talicia contributed $3.5 million, down from the first half of 2023 due to a 12% reduction in U.S. prescriptions, driven by employee terminations and other cost-cutting measures. Movantik recorded negative revenues of $0.9 million, primarily due to product returns. Excluding one-time items in the first half of 2023 related to the Movantik® divestiture, the operating loss and net loss improved by $9.9 million and $9.5 million, respectively, as these cost-cutting measures significantly reduced overall expenses
Post-balance sheet date, RedHill signed a Global Termination Agreement with Movantik Acquisition Co. and others (the "Agreement"). The Agreement resulted in RedHill receiving $9.9 million in cash and gaining full control over $0.74 million in a restricted account, while assuming $12.2 million in liabilities, leading to a net balance sheet reduction of approximately $2.3 million. The Agreement ended all existing credit ties and removed the lien against Talicia
TEL AVIV, Israel and RALEIGH, N.C., Aug. 29, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its first half 2024 financial results and operational highlights, for the six months ended June 30, 2024.
"The first six months of this year have realized significant accomplishments, laying the groundwork for numerous potential upcoming catalysts. RedHill is now in possession of a promising, advancing and largely financially de-risked development pipeline designed to address substantial and underserved indications in oncology, viral pandemic preparedness, nuclear/radioprotection and diabetes and obesity-related disorders," said Dror Ben-Asher, RedHill's Chief Executive Officer. "There is no doubt that the last four years have been a challenge, primarily as a result of the pandemic's negative impact on our commercial launches in the United States in the first half of 2020. However, we have been turning the ship around and I am immensely proud of our team that works tirelessly to create opportunities, deliver on plans and create value in the lab and in the clinic through new studies, generating additional patents and publications, identifying important new indications and forging the right partnerships for our assets, while maintaining a market leadership position with Talicia. We are executing on our plans to ensure a clear value-driven focus, operational efficiency and financial streamlining with a low cost-base, as well as a strengthened cash balance and solid control over all elements of our business."
Financial results for the six months ended June 30, 2024 (Unaudited)[2]
Net Revenues for the first half of 2024 were $2.6 million, compared to $5.4 million for the first half of 2023. Talicia net revenues were $3.5 million for the six months ended June 30, 2024, compared to $5.1 million for the six months ended June 30, 2023, mainly due to a 26% decrease in gross revenues and a 9% increase in Gross-to-Net deductions, mainly from increased Medicaid rebates. In the first half of 2024, $0.5 million of net revenues came from sales in the UAE. Talicia scripts in the U.S. in the first half of 2024 were down by approximately 12%, compared to the same period in 2023, mainly due to reduced promotion and marketing following employee terminations and other cost-cutting measures in the United States. These measures had a significant positive impact on reducing expenses, as detailed below.
Movantik had negative net revenues of $0.9 million in the first half of 2024, compared to negative net revenues of $0.1 million in the first half of 2023, mainly due to returns related to sales in the second and third quarters of 2020.
Gross Profit for the first half of 2024 was $1.2 million, compared to $3 million for the first half of 2023, in line with the decrease in Net Revenues as explained above and primarily attributable to the reduction in Talicia prescriptions following employee terminations and other cost-cutting measures.
Research and Development Expenses for the first half of 2024 were $0.7 million, as compared to $2.3 million for the first half of 2023. The decrease is mainly attributable to the costs from closing the RHB-204 clinical trial, which were recognized in the first half of 2023, and to ongoing cost-reduction measures.
Selling, Marketing, and General and Administrative Expenses for the first half of 2024 were $9 million, compared to $19 million for the first half of 2023. This decrease was primarily due to downsizing the U.S. workforce following the Movantik divestiture, leading to lower payroll and related expenses, and reduced sales force expenses.
Other Income – There was no other income for the first half of 2024, as compared to $43 million of other income for the first half of 2023. The other income recognized in the first half of 2023 was comprised of (i) $35.5 million from the divestiture of Movantik and (ii) $7.5 million from transitional services fees provided to the buyer of Movantik.
Operating Loss for the first half of 2024 was $8.4 million, compared to operating income of $24.7 million for the first half of 2023. The difference is primarily attributable to the changes resulting from the divestiture of Movantik the previous year, as detailed above. Excluding the other income from the Movantik transaction in 2023, the operating loss decreased by approximately $9.9 million, from an operating loss of $18.3 million for the first half of 2023, reflecting the positive operating impact of the cost-cutting measures.
Financial Income, net for the first half of 2024 was $5.4 million, compared to $26.3 million for the first half of 2023. In the first half of 2024, the income recognized was mainly attributable to warrants' revaluation, offset by offerings' expenses. In the first half of 2023, the income recognized was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC debt in exchange for the transfer of rights to Movantik.
Net Loss was $3.1 million for the first half of 2024, compared to net income of $51 million for the first half of 2023. This change was primarily attributable to the effects resulting from the sale of Movantik and ongoing cost-reduction measures, as detailed above. Excluding the other income and financial income from the Movantik transaction in 2023, the net loss decreased by approximately $9.5 million, from a net loss of $12.6 million for the first half of 2023, reflecting the positive net impact of the cost-cutting measures.
Total Assets as of June 30, 2024 were $22 million, as compared to $23 million as of December 31, 2023. The decrease was primarily attributable to a reduction in the inventory balance due to sales, as well as a reduction in right-of-use assets, due to termination of car leases in the six months ended June 30, 2024.
Total Liabilities as of June 30, 2024 were $22 million, as compared to $21 million as of December 31, 2023. The increase is mainly due to higher allowance from deductions from revenues and increased warrant-related derivative liabilities, partially offset by lower accounts payable, accrued expenses and lease liabilities (due to the car leases' termination).
Net Cash Used in Operating Activities for the six months ended June 30, 2024 was $6.2 million, compared to $17.8 million for the same period in 2023. The decrease in cash used was primarily due to settling pre-closing liabilities associated with Movantik and other operational activities in the six months ended June 30, 2023. Furthermore, this reduction is attributable to the cost-cutting measures mentioned above.
Net Cash Provided by Financing Activities for the six months ended June 30, 2024 was $7.9 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2024. For the six months ended June 30, 2023, Net Cash Provided by Financing Activities was $4.8 million, comprised primarily of the net proceeds from securities offerings in the six months ended June 30, 2023, and the decrease in restricted cash, partially offset by the repayment of payables related to the purchase of intangible assets.
Cash Balance as of June 30, 2024 was $8.2 million1.
R&D and Commercial Highlights:
R&D:
RedHill's pipeline is centered around opaganib[3] & RHB-107[4], two promising, potentially broad utility, novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles. Both candidates are advancing in predominantly U.S. government-supported, externally-funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval.
Between them, they are in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection (Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure).
Being (i) easy to administer and distribute and (ii) viral mutation-resistant, they are ideally suited for stockpiling strategies in the event of nuclear/chemical incidents and viral pandemic scenarios.
Opaganib:
U.S. Army program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology)
Discussions ongoing for a potential externally-funded, late-stage study in an additional underserved oncology indication
Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders – a market projected to be worth approximately $100 billion within the next decade
U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for ARS and Sulfur Mustard exposure
Late-stage COVID-19 program continues to address a multi-hundreds of millions of dollars market
New opaganib publications:
- The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. Publication showed that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation[5]
- Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based Upon FiO2 Requirements. Publication showed that oral opaganib reduced mortality by 62% and delivered improved time to room air, and faster time to hospital discharge in a large group of 251 hospitalized, moderately severe COVID-19 patients requiring a Fraction of inspired Oxygen up to and including 60% (FiO2=60%). The paper also indicates that due to the lack of treatment effect in patients requiring FiO2>60%, this may represent a threshold level for disease irreversibility (likely due to more severe COVID-19 lung disease) and be an important patient selection clinical biomarker, a key finding for future therapeutic strategies and studies[6]
New Chinese patents granted for opaganib:
- In combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response. Provides protection for opaganib's potential use in combination with a range of approved and in-development ICIs across a growing range of indications through 2040
- As a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus); valid through 2035
RHB-107 (upamostat):
COVID-19: Enrollment ongoing in the U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment. Enrollment is estimated to be completed in the first half of 2025
U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies
RHB-104[7]: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease
Commercial:
Talicia: The leading prescribed branded H. pylori therapy in the U.S., maintaining leadership position with a streamlined commercial team:
Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use
Potential manufacturing developments aiming to open additional new markets underway
Now commercially launched in the UAE, triggering RedHill's eligibility for potential milestone and royalty payments
Two new U.S. patent grants covering Talicia as:
- A method for eradicating H. pylori regardless of BMI, valid until May 2042
- Use as an all-in-one treatment of H. pylori infection, valid until 2034
That too.
USPTO Grants Notice of Allowance for Additional Patent on IceCure's Novel Cryogenic Pump Technology: Reinforces IceCure's Global IP Leadership in Cryoablation Technologies
https://finance.yahoo.com/news/uspto-grants-notice-allowance-additional-123000903.html
Further broadens the uses and applications of IceCure's cryoablation platform into a wide range of technology fields
Over 50 patents issued and allowed worldwide for IceCure's platform cryoablation technology
CAESAREA, Israel, Aug. 28, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for a continuation application based on the Company's issued patent titled "Cryogen Pump". The original patent, which was also issued by the European Patent Office and the Japan Patent Office, as well as the continuation, will be in effect until 2041.
"This new patent will support IceCure's potential for increasing the number of indications, procedures and applications that can be performed with our next-generation industry-leading platform cryoablation systems," stated IceCure Chief Executive Officer Eyal Shamir. "We believe that further fortifying our cryoablation intellectual property ("IP") estate in the U.S. is well timed both with respect to the indications for which we already have U.S. Food and Drug Administration ("FDA") approval as well as the FDA's decision on clearance for early-stage breast cancer, the decision which we expect in the first quarter of next year."
IceCure's novel cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer duration procedures without the need to refill liquid nitrogen. Moreover, this pump enables the use of a wider range of cryoprobes and catheters. The pump has been integrated into IceCure's next-generation XSense™ cryoablation system.
The long and winding road
That leads to ....approval.
7.90 -0.53 (-6.29%)
As of 10:12 AM EDT. Market Open.
Titanic!
What an FDA approval could do.
This is a positive passage:
RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma
https://finance.yahoo.com/news/redhills-opaganib-granted-orphan-drug-110000986.html
Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths[1],[2]
Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits
The neuroblastoma market is expected to reach almost $1.5 billion before mid-2030s[3]
This is the second orphan drug designation by the FDA for opaganib in oncology, after cholangiocarcinoma (bile duct cancer, CCA)
With multiple U.S. government collaborations ongoing, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles
TEL AVIV, Israel and RALEIGH, N.C., Aug. 26, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.
Orphan Drug designation provides for a seven-year marketing exclusivity period should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits.
"RedHill is proud to have received a second orphan-drug designation for opaganib in oncology, following its previous designation for cholangiocarcinoma (CCA, also known as bile duct cancer). This designation for neuroblastoma – the most common infancy malignancy and for which new options are urgently needed – adds to opaganib's potential as a novel oncological agent," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "Opaganib has broad oncology potential with promising preliminary clinical data in solid tumor cancers such as prostate cancer and CCA, and data from a range of U.S. government supported and Apogee conducted preclinical studies in various indications, including radioprotection, and also in combination with RedHill's RHB-107. We also see such utility extending to the potential for opaganib to have a sensitizing effect in hormone receptor pathway inhibition therapy, which the Company expects to test in a planned externally funded Phase 2 study."
Neuroblastoma usually affects children aged five or younger but does also occur in older children. In the United States, approximately 650 new cases are diagnosed each year, accounting for around 10% of all childhood cancer cases. Treatment typically involves a combination of surgery, chemotherapy, radiation therapy, and sometimes targeted therapy or immunotherapy. New options are urgently needed.
The neuroblastoma market is expected to reach almost $1.5 billion before the middle of the next decade.
Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection.
About Neuroblastoma
Neuroblastoma is a type of cancer most commonly affecting babies and young children. It is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S. it accounts for up to around 10% of all childhood cancer cases. It affects around 11 to 13 kids per million children aged younger than 15 years old – with incidence rising to 65 per million in babies under one year old, equating to approximately 650 new cases each year.
Neuroblastoma originates from nerve cells called neuroblasts, which are found in the adrenal glands (located above the kidneys) and in nerve tissue along the spine, chest, abdomen, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern.
The outlook for children with neuroblastoma can vary widely. Factors affecting prognosis include the stage of the disease at diagnosis, the age of the child, and specific biological characteristics of the tumor. Neuroblastoma is known for its ability to sometimes regress spontaneously in very young children, but it can also be aggressive and challenging to treat, accounting for 15% of pediatric cancer-related deaths.
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including obesity-related syndromes, prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH: The Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health, for the nuclear medical countermeasures (MCM) product development pipeline selected opaganib for development as a potential treatment for Acute Radiation Syndrome (ARS); and the Chemical Medical Countermeasures (Chem MCM) Program and the Chemical Countermeasures Research Program (CCRP), managed respectively by the Administration for Strategic Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) and NIH/NIAID selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure.
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.
Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
I won't be too surprised if ICCM
eod in the green.
Well, that's a good start anyway, and the market
sure is positively noticing the company as the
rising sp indicates.
Time will tell if RDHL sp momentum continues!
I for one am cautiously optimistic!
$RDHL RedHill Biopharma
https://finance.yahoo.com/news/three-undiscovered-gems-united-states-150814759.html
Overview: RedHill Biopharma Ltd. is a specialty biopharmaceutical company that primarily focuses on gastrointestinal and infectious diseases, with a market cap of $256.99 million.
Operations: RedHill Biopharma Ltd. derives its revenue from the sale of specialty biopharmaceutical products targeting gastrointestinal and infectious diseases. The company has a market cap of $256.99 million.
RedHill Biopharma, a small cap stock, recently reported a significant one-off gain of US$54.6M for the year ending December 31, 2023. The company is debt-free and has maintained this status for over five years. Despite becoming profitable last year, its share price has been highly volatile over the past three months. Recent developments include the launch of Talicia in the UAE and positive results from studies on opaganib for Type 2 diabetes treatment.
9.26 +0.73 (+8.66%)
As of 10:13 AM EDT. Market Open
Cool.
Talicia® Launched in the United Arab Emirates
https://finance.yahoo.com/news/talicia-launched-united-arab-emirates-110000964.html
In this article:
RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE)
The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales
Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[1] for the treatment of H. pylori, a bacterial infection that affects 41% of the UAE population[2] and over 50% of the world's adult population[3]
RALEIGH, N.C., Aug. 21, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the launch of Talicia (omeprazole magnesium, amoxicillin and rifabutin)[4] in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori (H. pylori) infection. The commercial launch of Talicia in the UAE triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori.
"We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern. With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies[5],[6], there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners."
Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[7]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient obesity or diabetic status, neither of which impact Talicia's safety or efficacy, according to data from post-approval post-hoc analysis[8],[9].
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated two million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16].
About Talicia
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[17] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[18].
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com
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[19], and Aemcolo®, for the treatment of travelers' diarrhea in adults[20]. 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.
8.21 +0.18 (+2.22%)
As of 1:46 PM EDT. Market Open.
This i did not expect!!!
Indeed we do. Hopefully it is a Marathon run.
7.98 -0.05 (-0.59%)
As of 11:36 AM EDT. Market Open.
Now, that is a very pleasant surprise.
If/when FDA aaproval achieved, it is possible.
Until then, hopefuly sales will continue growing,
othewise some sort of partnership from BP will
serve a good enough sp catalyst.
Unless some good news, RDHL
is doomed!
0.7266 +0.0866 (+13.6722%)
As of 10:39 AM EDT. Market Open.
Volume 920,551
Avg. Volume 423,164
https://ih.advfn.com/stock-market/NASDAQ/biolinerx-BLRX/stock-news/94408736/form-6-k-report-of-foreign-issuer-rules-13a-16
Item 3
3.To approve an increase in the Company’s authorized share capital, and to amend the Company’s Articles of Association accordingly
For an eventual offering?!
IceCure Medical Reports 20% Growth in ProSense® System and Probe Sales for the First Half of 2024; Reflects Continued Adoption in the U.S. and Other Global Markets
https://finance.yahoo.com/news/icecure-medical-reports-20-growth-123000882.html
Near-term regulatory and operating catalysts have potential to accelerate adoption of ProSense® for treatment of early-stage, low risk breast cancer
Conference call to be held today at 10:00 am Eastern Time
CAESAREA, Israel, Aug. 20, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today reported financial results as of and for the six months ended June 30, 2024.
Significant Near and Short Term Value Enhancing Catalysts
U.S. Food and Drug Administration ("FDA") Medical Device Advisory Committee expected Q4 2024. The purpose of the meeting is to obtain independent expert advice on scientific, technical, and policy matters related to the Company's De Novo Marketing Clearance Request for a minimally invasive alternative treatment for women diagnosed with early-stage, low risk breast cancer.
The FDA will review and evaluate the recommendation of the Medical Device Advisory Committee and is expected to have a final decision regarding marketing clearance of ProSense® in early-stage, low risk breast cancer by early 2025.
Data from interim results of the Company's ICESECRET, a prospective, multicenter, single-arm clinical trial of ProSense® in the treatment of kidney cancer, is expected to be presented by December 2024.
The Company's partner in Japan, Terumo Corporation, is expected to file for regulatory approval of ProSense® for early-stage low risk breast cancer with endocrine therapy in Japan in the first quarter of 2025, with the aim of receiving clearance and making the Company's cryoablation system more commercially available to physicians and patients alike in Japan.
With 15 ongoing independent studies being performed globally, the Company expects additional third-party data on ProSense® will be published in medical journals and presented at prestigious medical conferences.
"We have achieved all of our primary objectives for the first half of 2024, and we are now in the process of preparing for the FDA Medical Device Advisory Committee, which we expect to be scheduled for Q4," stated IceCure Medical's CEO, Eyal Shamir. "The data from the ICE3 study has been overwhelmingly positive, and with a reported 100% patient and physician satisfaction rate, our goal is to highlight these results and leverage the expert testimony to secure a favorable recommendation from the committee to treat women diagnosed with early-stage, low risk breast cancer, and to ensure we maintain the forward momentum through year-end and into 2025 upon potential clearance from the FDA.
"The U.S. is the largest healthcare market in the world, and as a patient-centric company, we believe it's critically important to offer patients a safe and proven non-surgical procedure with a system that is cleared in 15 countries, including in the U.S. Moreover, we strongly believe that our first half 2024 system and probe sales growth of 20%, notwithstanding the revenue recognition from Terumo, is primarily due to women and their physicians making a conscious choice to use ProSense® and avoid a surgical procedure because it's a win-win scenario for patient, physician, health provider, and payor."
Second Quarter and Recent ProSense® Efficacy & Safety Data Reported by Independent Researchers
ProSense® Destroyed 100% of Breast Cancer Tumors in Independent Study of Patients Who Chose Cryoablation Instead of Surgery: The aim of the study titled "Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients" published in the British Journal of Radiology was to evaluate the acceptance of percutaneous cryoablation treatment by patients with early-stage breast cancer who choose not to have surgery. Of the 45 patients offered cryoablation with ProSense®, 43 patients, or 95.6% accepted. 36 of these, representing 39 malignant tumors (median size 24mm), proceeded to undergo cryoablation. The median age of patients treated with cryoablation was 87, with a range of 60-96. After a median follow-up of 16 months, the complete ablation rate in luminal A and B breast cancer with tumors = 25mm was 100%. No major complications were seen.
Zero (0%) Breast Cancer Local Recurrence 5 Years Following Treatment in Japan with ProSense®: Data from a study performed in Japan was published in an article titled "Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan," in the journal Breast Cancer. Eighteen early-stage breast cancer patients, with a mean age of 59.0 [±9.0 years], with a mean tumor size of 9.8 ±2.3 millimeters, who underwent treatment with ProSense® were followed for a mean of 44.3 months. No patients had local recurrence or distant metastasis in the 5-year follow-up. No serious adverse events were reported. Cosmetic outcomes were excellent and the overall patient satisfaction level and patient quality of life improved post-cryoablation.
European Study Provided More Evidence Supporting ProSense® Treatment for Metastatic and Recurrent Breast Cancer: Data published in the highly influential peer-reviewed journal, Cancers, concluded cryoablation with ProSense® is a safe, local treatment for breast cancer with a low complication rate, high complete ablation rate and satisfactory overall survival (OS), progression free survival (PFS) and local tumor control. The recurrence rate was 8.9% in a population of 45 patients who had previously received various therapies before cryoablation including surgery, radiation therapy, or chemotherapy with tumor sizes of up to 4 centimeters in diameter. Of those patients, 11 had recurrent tumors and 21 had metastatic disease. This higher-risk population contrasts with the early-stage breast cancer patient subjects in IceCure's U.S. ICE3 trial. The European study titled "CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience" was conducted at Goethe University in Germany.
99.74% Recurrence Free Rate for Women with Breast Cancer Treated with ProSense® in Japan: From April 2014 through August 2020, 389 breast cancer patients with tumor lesions of less than 15 millimeters in diameter were treated with ProSense®. The ipsilateral breast tumor recurrence rate (IBTR) was 0.26%, resulting in a 99.74% recurrence free rate. These data were presented at 32nd Annual Meeting of the Japanese Breast Cancer Society, where the demand for minimally invasive breast cancer treatment was an overarching theme.
Financial Results for the Six Months Ended June 30, 2024
Sales of ProSense® systems and disposable probes for the six months ended June 30, 2024 grew by 20% to $1,654,000 compared to $1,373,000 for the six months ended June 30, 2023. The growth was primarily attributable to sales in Europe, the U.S., Japan and other territories in Asia which were partially offset by a decrease in sales in China. Total Revenue for the six months ended June 30, 2024, grew to $1,754,000 from $1,647,000 for the six months ended June 30, 2023 due to an increase in the sale of ProSense® systems and disposables, which was partially offset by a decrease in revenue recognition and other services in Japan of $100,000 and $274,000 in the first six months of 2024 and 2023, respectively.
Gross profit for the six months ended June 30, 2024 grew to $799,000 from $754,000 for the six months ended June 30, 2023. Gross margin for the six months ended June 30, 2024 and for the six months ended June 30, 2023 was 46%. Non-GAAP gross profit for the six months ended June 30, 2024 increased to $699,000 from $480,000 for the six months ended June 30, 2023, an increase of $219,000 or 46%. Non-GAAP gross margin for the six months ended June 30, 2024 grew to 42% from 35% for the six months ended June 30, 2023. The increase in non-GAAP gross profit and non-GAAP gross margin, which exclude revenue from the exclusive distribution agreements and other services in Japan, was attributable to the increase of 20% in revenue from sales of ProSense® systems. Non-GAAP gross profit and non-GAAP gross margin are financial measures that may be defined as "non-GAAP financial measures" by the U.S. Securities and Exchange Commission ("SEC"). For a reconciliation of these non-GAAP financial measures to the nearest comparable GAAP measure, see Appendix A to this press release.
Research and development expenses for the six months ended June 30, 2024 were $3,536,000 compared to $4,190,000 for the six months ended June 30, 2023. The decrease was primarily due to a reduction in development expenses for the XSense™ System, which received FDA clearance in June 2024, and a decrease in clinical and regulatory costs as the Company concluded the ICE3 study in March 2024 and submitted the application to the FDA in April 2024. Sales and marketing expenses for the six months ended June 30, 2024 were $2,296,000 compared to $2,253,000 million for the six months ended June 30, 2023. General and administrative expenses for the six months ended June 30, 2024, narrowed to $1,845,000 from $2,349,000 for the six months ended June 30, 2023.
Total operating expenses for the six months ended June 30, 2024 decreased to $7,677,000 from $8,792,000 for the six months ended June 30, 2023. The decrease in operating expenses was attributable to reductions in research and development, and general and administrative expenses, due to the Company's initiative to reduce non-critical operating expenses which were partially offset by an increase in sales and marketing expenses.
Net loss for the six months ended June 30, 2024 narrowed to $6,690,000 million, or $0.14 per share compared to a net loss of $7,657,000 million, or $0.17 per share, for the same period last year.
As of June 30, 2024, the Company had cash and cash equivalents, including short-term deposits, of approximately $10.5 million, compared to $11 million as of December 31, 2023. As of July 31, 2024, the Company had cash and cash equivalents of approximately $10.3 million. During the first half of 2024, the Company raised $4.7 million in net proceeds from the sale of 3,787,976 ordinary shares under its at-the-market ("ATM") offering facility.
Use of Non-U.S. GAAP Measures
In addition to disclosing financial results prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP), this press release contains certain financial measures which may be defined as "non-GAAP financial measures" by the SEC. The Company defines non-GAAP gross profit as gross profit less revenue from exclusive distribution agreements and other services. The Company has provided non-GAAP gross profit in this press release because it is a key measure used by management and the board of directors as an indication of our gross profit from sales of our systems and disposables and management believes that it is useful to investors' understanding and assessment of the Company's gross profit without the impact of revenue recorded from the Company's exclusive distribution agreements and other services. The Company has provided a reconciliation below of non-GAAP gross profit and non-GAAP gross margin to the most directly comparable financial measure calculated and presented in accordance with U.S. GAAP. The non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP and the financial results calculated in accordance with U.S. GAAP and reconciliations to those financial results should be carefully evaluated.
Conference call & webcast info:
Tuesday, August 20, 2024, at 10:00 am EDT
US: 1-888-407-2553
Israel/International: +972-3-918-0696
A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ2-2024
A recording of the webcast will be available at: ir.icecure-medical.com
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.