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Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results
https://finance.yahoo.com/news/protalix-biotherapeutics-reports-fiscal-2023-105000190.html
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, March 14, 2024 /PRNewswire/ -- 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 reported financial results for the fiscal year ended December 31, 2023, and provided a business update.
"2023 was a significant year for Protalix, as we received regulatory approvals of Elfabrio for the treatment of adult patients with Fabry disease and advanced our growing pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "As the second drug produced through our proven protein expression platform, Elfabrio's approval is a welcome milestone for Fabry disease patients and their families. Our commercial partner Chiesi Global Rare Diseases is continuing to position Elfabrio for global success, with launches underway in the United States, the European Union, the UK and additional markets where approvals were granted. As we continue to provide Chiesi with operational support for its activities, we have turned our attention to developing our innovative pipeline. For example, PRX-115, our proprietary recombinant PEGylated uricase for the treatment of severe gout, is currently being studied in a first-in-human phase I clinical trial. We anticipate that results from the trial will be published in the second quarter of 2024. As a company powered by a professional team and solid financials, and with the potential for revenue growth, we are poised for an exciting future and look forward to making a positive impact on patients' lives and delivering long-term value to our stockholders."
Fiscal Year 2023 and Recent Business Highlights
Regulatory and Commercial Advancements
The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, gained marketing authorizations in the United States, the European Union, the UK, Switzerland and Israel for Elfabrio® (pegunigalsidase alfa), a PEGylated recombinant human a-Galactosidase-A enzyme, for the treatment of adult patients with confirmed Fabry disease. Elfabrio is administered via intravenous infusion at a dose of 1 mg/kg every two weeks.
On May 5, 2023, the Company announced that the European Commission (EC) granted marketing authorization to Elfabrio in the European Union for the treatment of adult patients with Fabry disease.
On May 10, 2023, the Company announced that the U.S. Food and Drug Administration (FDA) approved Elfabrio in the United States for the treatment of adult patients with Fabry disease.
On August 15, 2023, Chiesi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Elfabrio in Great Britain for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
On September 11, 2023, Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, announced the approval of Elfabrio in Switzerland for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
In January 2024, the Israeli Ministry of Health granted principle approval of Elfabrio for adult patients with a confirmed diagnosis of Fabry disease.
The FDA approval triggered a $20.0 million milestone payment from Chiesi. In addition, the Company generated $17.5 million from sales of Elfabrio to Chiesi during 2023 post-regulatory approval, as Chiesi is building its inventory and recruiting commercial patients in the United States and Europe.
Clinical Developments
In March 2023, the first patient was dosed in the Company's First in Human (FIH) Phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study, which is fully-enrolled, is being conducted at the New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. The Company anticipates that preliminary results from the study will be published in the second quarter of 2024.
Corporate Developments
On September 14, 2023, Eliot Richard Forster, Ph.D. began his tenure as Chairman of the Board of Directors, replacing former Chairman Zeev Bronfeld, who retired for personal reasons.
Fiscal Year 2023 Financial Highlights
The Company recorded revenues from selling goods of $40.4 million for the year ended December 31, 2023, an increase of $15.1 million, or 60%, compared to revenues of $25.3 million for the year ended December 31, 2022. The increase resulted primarily from an increase of $14.1 million in sales of Elfabrio drug product to Chiesi, following the approvals by the FDA and the European Medicines Agency (EMA) of Elfabrio, an increase of $0.1 million in sales to Pfizer Inc., or Pfizer, and of $0.9 million in sales to Brazil, resulting from timing differences.
The Company recorded revenues from license and R&D services of $25.1 million for the year ended December 31, 2023, an increase of $2.8 million, or 13%, compared to revenues of $22.3 million for the year ended December 31, 2022. The increase resulted from the $20.0 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio which was partially offset by a decrease of $17.2 million in revenues recognized in connection with the R&D performance obligation under the Chiesi Agreements as the Company has completed the phase III clinical program thereunder. Revenues from license and R&D services represent primarily the revenues the Company recognized for services provided under the Chiesi Agreements.
Cost of goods sold was $23.0 million for the year ended December 31, 2023, an increase of $3.4 million, or 17%, compared to cost of goods sold of $19.6 million for the year ended December 31, 2022. The increase in cost of goods sold was primarily the result of the increase in sales of goods to Chiesi, Brazil and to Pfizer. Sales to Chiesi included certain drug substance costs which had already been recognized as research and development expenses as it was produced as part of research and development activities. Accordingly, the related cost of goods sold does not include the costs of such drug substance.
For the year ended December 31, 2023, the Company's total research and development expenses were approximately $17.1 million, comprised of approximately $6.3 million in subcontractor-related expenses, approximately $7.8 million of salary and related expenses, approximately $0.6 million of materials-related expenses and approximately $2.4 million of other expenses. For the year ended December 31, 2022, the Company's total research and development expenses were approximately $29.3 million, comprised of approximately $17.8 million in subcontractor-related expenses, approximately $7.3 million of salary and related expenses, approximately $1.4 million of materials-related expenses and approximately $2.8 million of other expenses. Total decrease in research and developments expenses was $12.2 million, or 42%, for the year ended December 31, 2023 compared to the year ended December 31, 2022. The decrease in research and development expenses resulted primarily from a $11.5 million decrease in subcontractor-related expenses in connection with the PRX-102 clinical trials, and a $0.8 million decrease in materials-related expenses.
Selling, general and administrative expenses were $15.0 million for the year ended December 31, 2023, an increase of $3.3 million, or 28%, from $11.7 million for the year ended December 31, 2022. The increase resulted primarily from an increase of approximately $2.3 million in one-time cash bonuses, share-based compensation and salary and salary-related expenses, as well as an increase of $0.3 million in travel, conferences and employee training expenses.
Financial expense, net was $1.9 million for the year ended December 31, 2023, an increase of $0.5 million, or 36%, compared to financial expenses of $1.4 million for the year ended December 31, 2022. The increase was primarily due to a decrease of $0.9 million in income related to exchange rates as well as an increase in interest expenses of $0.7 million which was partially offset by a gain recognized due to conversions of a portion of the 2024 Notes of $0.4 million and a $0.6 million increase in interest income.
For the year ended December 31, 2023, the Company recorded income taxes of approximately $0.3 million, a decrease of $0.2 million, or 40%, compared to tax expenses of $0.5 million for the year ended December 31, 2022. The income taxes resulted primarily from the provision for current taxes on income mainly derived from U.S. taxable global intangible low-taxed income (GILTI) mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act (the "TCJA"). Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year. The net income taxes gives effect to a valuation allowance release equal to approximately $3.1 million.
Cash, cash equivalents and short-term bank deposits were approximately $44.6 million at December 31, 2023.
Net income for the year ended December 31, 2023 was approximately $8.3 million, or $0.12 per share, basic, and $0.09 per share, diluted, compared to a net loss of $14.9 million, or $0.31 per share, basic and diluted, for the same period in 2022.
Conference Call and Webcast Information
The Company will host a conference call today, March 14, 2024 at 8:30 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Thursday, March 14, 2024
Time: 8:30 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13744193
Call me™: https://tinyurl.com/4pkhcxcj
The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/mumnf9da
Conference ID: 13744193
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
Protalix BioTherapeutics FY Earnings Preview
Mar. 13, 2024 12:32 PM ETProtalix BioTherapeutics, Inc. (PLX) Stock
By: Pranav Ghumatkar, SA News Editor
Protalix BioTherapeutics (NYSE:PLX) is scheduled to announce
FY earnings results on Thursday, March 14th, before market open.
The consensus EPS Estimate is $0.10 (+145.5% Y/Y) and the consensus Revenue Estimate is $63.95M (+1.7% Y/Y).
Over the last 1 year, PLX has beaten EPS estimates 25% of the time and has beaten revenue estimates 100% of the time.
Truth is i have not expected RDHL to move
up on these patent news although the recent
patent is worth more than the previous one.
(At least Talicia is a selling product!)
What i do expect is Barda to land a stockpile
contract of several or more $ millions,
eg:
https://www.outsourcing-pharma.com/Article/2018/09/21/Siga-signs-629m-multiyear-contract-with-BARDA-for-smallpox-drug-stockpiling
or:
https://ir.mediwound.com/news-releases/news-release-details/mediwound-announces-additional-10-million-award-barda-0
This is my expectation. I truely believe it will happen someday!
For this reason i am still holding and hanging on.
RedHill Announces New USPTO Patent Covering Talicia® Through 2034
https://finance.yahoo.com/news/redhill-announces-uspto-patent-covering-110000659.html
U.S. Patent and Trademark Office (USPTO) issues new patent covering Talicia1 as an all-in-one treatment of Helicobacter pylori (H. pylori), supporting Talicia protection until February 12, 2034
This new patent adds to the existing strong intellectual property portfolio protecting Talicia, including composition of matter and other patents and FDA-granted data exclusivities granted under the GAIN QIDP designation and section 505(b)(2)
Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori, providing an optimized antibiotic resistance profile and the leading branded first-line therapy prescribed by U.S. gastroenterologists2 for H. pylori infection, which affects approximately 35% of the U.S. adult population3
TEL AVIV, Israel and RALEIGH, N.C., March 11, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent covering Talicia1 as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori (H. pylori) infection (Patent No. 11,931,463 to be issued March 19, 20244). Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population and this patent is expected to provide protection for Talicia until February 12, 2034.
"Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori. Its components and formulation are optimized to provide patients with the right medications for successful H. pylori eradication with an optimized resistance profile, which is significant in the face of growing microbial resistance to clarithromycin-based regimens," said Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs. "The granting of this new U.S. patent further adds to the strong intellectual property protecting Talicia, including the recently announced patent for treatment regardless of patient Body Mass Index (BMI), several other composition of matter and other patents, and additional FDA-granted data exclusivities granted under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation and the approval of Talicia under section 505(b)(2)."
About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35% of the U.S. population, with an estimated two million patients treated annually5. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. 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.
About Talicia
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), approved by the U.S. Food and Drug Administration (FDA) for the treatment of H. pylori infection in adults.
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to 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 American College of Gastroenterology, the FDA and the WHO in recent years.
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 adherent10 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm11. 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.
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: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.
You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:
Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.
Call your healthcare provider immediately if while taking Talicia you develop:
New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.
Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
You may experience a brown-orange discoloration of your urine or tears while taking Talicia.
The information here is not comprehensive. Talk to your healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is indicated for the treatment of Helicobacter pylori infection in adults.
Click here for the full Prescribing Information for TALICIA.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 adults1, 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, including, but not limited to, statements regarding the intended use of net proceeds from the offering, 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 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 addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. 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 addition of new revenue generating products or out-licensing transactions will not occur; the 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; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 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 28, 2023. 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 & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Commercial
1 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.
2 IQVIA XPO Data on file
3 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
4 Patent issued by The United States Patent and Trademark Office (USPTO), the federal agency for granting U.S. patents and registering trademarks.
5 IQVIA Custom Study for RedHill Biopharma, 2019
6 Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
7 NIH – Helicobacter pylori and Cancer, September 2013.
8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
10 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
11 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
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.
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Business Wire
Namodenoson Treatment for Pancreatic and Liver Cancer: Data will be Discussed in Out-licensing and Distribution Partnering Meetings at Bio Europe Conference
Mon, March 11, 2024 at 1:00 PM GMT+2
In this article:
Namodenoson Treatment for Pancreatic and Liver Cancer: Data will be Discussed in Out-licensing and Distribution Partnering Meetings at Bio Europe Conference
https://finance.yahoo.com/news/namodenoson-treatment-pancreatic-liver-cancer-110000148.html
PETACH TIKVA, Israel, March 11, 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 oncology and inflammatory diseases, today announced its VP of Business Development, Dr. Sari Fishman, will present data from the pancreatic and liver cancer programs during numerous partnering meetings at the BIO-Europe Spring 2024 in Barcelona, Spain, on Mar 18-27, 2024 (https://informaconnect.com/bioeurope-spring/).
Can-Fite’s pipeline of indications includes Namodenoson for the treatment of advanced liver cancer and pancreatic cancer; both indications have been licensed to the Swiss company Ewopharma for Eastern Europe. The liver cancer indication has been licensed as well to CMS in China and CKD in South Korea. Piclidenoson has been out-licensed to Cipher in Canada; Gebro Pharma for Swiss, Spain, Austria; CMS for China; and Kyongboo for South Korea. Each of the deals include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.
"Advanced liver cancer and pancreatic cancer are Can-Fite’s clinical-stage indications for Namodenoson and am delighted with the interest that Namodenoson is raising with companies that will participate in the Bio Europe Conference and are experts in drug development and distribution in the oncology arena. The conference provides us with the opportunity to present our other developments to lead pharmaceutical companies," stated Dr. Sari Fishman, VP Business Development at Can-Fite.
Retail investors who hold 38% of MediWound Ltd. (NASDAQ:MDWD) gained 15%, institutions profited as well
editorial-team@simplywallst.com (Simply Wall St)
https://finance.yahoo.com/news/retail-investors-hold-38-mediwound-113038913.html
Thu, March 7, 2024 at 1:30 PM GMT+2
Key Insights
MediWound's significant retail investors ownership suggests that the key decisions are influenced by shareholders from the larger public
A total of 10 investors have a majority stake in the company with 51% ownership
16% of MediWound is held by Institutions
To get a sense of who is truly in control of MediWound Ltd. (NASDAQ:MDWD), it is important to understand the ownership structure of the business. The group holding the most number of shares in the company, around 38% to be precise, is retail investors. In other words, the group stands to gain the most (or lose the most) from their investment into the company.
While retail investors were the group that reaped the most benefits after last week’s 15% price gain, institutions also received a 16% cut.
Protalix BioTherapeutics to Announce Fiscal Year 2023 Financial and Business Results on March 14, 2024
https://finance.yahoo.com/news/protalix-biotherapeutics-announce-fiscal-2023-115000023.html
Company to host conference call and webcast at 8:30 a.m. EDT
CARMIEL, Israel, March 7, 2024 /PRNewswire/ -- 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 will release its financial results for the fiscal year ended December 31, 2023 and provide a business update on Thursday, March 14, 2024.
Management will host a conference call with investors to discuss the financial results and provide a business update.
Conference Call Details:
Date: Thursday, March 14, 2024
Time: 8:30 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13744193
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Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/mumnf9da
Conference ID: 13744193
Participants are requested to access the call at least 15 minutes ahead of the conference to register, download and install any necessary audio software. A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023.
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others.
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-announce-fiscal-year-2023-financial-and-business-results-on-march-14-2024-302082682.html
SOURCE Protalix BioTherapeutics, Inc.
16.58+1.16 (+7.52%)
At close: March 6 04:00PM EST
16.80 +0.22 (+1.33%)
After hours: 08:00PM EST
Volume 259,831
Avg. Volume 38,857
MediWound (MDWD) Moves 7.1% Higher: Will This Strength Last?
https://finance.yahoo.com/news/mediwound-mdwd-moves-7-1-134600263.html
The sheer volume with daily 52w/h indicates
positive developments in the works.
At $16 a new w/h high is set.
15.42+1.02 (+7.08%)
At close: March 5 04:00PM EST
Volume 133,218
Avg. Volume 37,013
Robust Volume, a Bullish sign!
15.48+1.08 (+7.50%)
As of 09:55AM EST. Market open.
Volume 47,122
Avg. Volume 36,598
Just broke 52W/H
RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs
https://finance.yahoo.com/news/redhills-opaganib-selected-evaluation-barda-120000143.html
The U.S. government's Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP), managed respectively by ASPR/BARDA and NIH/NIAID, in collaboration with Battelle[1], have selected opaganib for evaluation as a potential medical countermeasure (MCM) against Sulfur Mustard exposure
Opaganib, a novel oral small molecule, is the first sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure
Selection for the therapeutic testing/screening program, following opaganib's previous acceptance into the Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome (ARS), provides the potential to see broad activity across both radiation and Sulfur Mustard injuries
Opaganib has five-year shelf-life and is easy to administer and distribute for use against potential chemical weapon attack, if approved by the U.S. Food and Drug Administration (FDA)
Opaganib is being developed for multiple additional indications, including COVID-19, acute respiratory distress syndrome (ARDS) and oncology
TEL AVIV, Israel and RALEIGH, N.C., March 5, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, together with its partner Apogee Biotechnology Corporation, today announced that opaganib[2] has been selected by the U.S. government's Chemical Medical Countermeasures (Chem MCM) Program and Chemical Countermeasures Research Program (CCRP) for evaluation as a potential medical countermeasure (MCM) against inhalation Sulfur Mustard exposure. The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.
The Chem MCM Program is administered by the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), and the CCRP is managed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the HHS National Institutes of Health (NIH).
Sulfur Mustard is a powerful alkylating chemical warfare agent. Exposure to Sulfur Mustard causes extensive skin blistering and severe injury to the eyes, lungs, and multiple organs, causing potentially fatal damage. Primarily affecting the lungs, Sulfur Mustard poisoning can result in symptoms such as acute lung injury, acute respiratory distress syndrome, bronchiolitis obliterans, fibrosis, and subsequent associated infections.
"With the alarming increase in global geo-political instability, the opportunity to evaluate opaganib as a potential vital protective agent against chemical attack is inspiring. We, and our development partner, Apogee Biotechnology Corporation, are delighted to partner with the NIH/NIAID, ASPR/BARDA, and Battelle in our efforts to make a significant difference in this area of huge medical and societal need," said Dror Ben-Asher, RedHill's Chief Executive Officer. "Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure. Its selection for the U.S. government's Chemical Countermeasures Research Program, following opaganib's previous acceptance into the U.S government's Radiation and Nuclear Countermeasures Program for Acute Radiation Syndrome (ARS), provides the potential to see broad activity across both radiation and Sulfur Mustard injuries."
Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute for use against potential chemical weapon attack, if approved by the FDA.
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 gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).
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 was selected by the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases, part of the HHS National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS).
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc., Nasdaq: GILD), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.
Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
About Battelle
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.
14.40+0.20 (+1.41%)
At close: March 4 04:00PM EST
Volume 189,777
Avg. Volume 34,001
Nice Finish.
BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production
https://finance.yahoo.com/news/biolinerx-strengthens-intellectual-property-estate-120000297.html
- New patent, when issued, will be valid until December 2041 -
- Additional IP complements U.S. market exclusivity awarded to BioLineRx upon FDA approval of APHEXDA® (motixafortide) in September 2023 as a result of its Orphan Drug and New Chemical Entity designations -
TEL AVIV, Israel, March 4, 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 received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production.
In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA® (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.
"This is a very meaningful addition to our IP portfolio as we look to scale up the production of motixafortide to support both the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients as well as the numerous ongoing clinical trials underway in other indications, including metastatic pancreatic cancer and for gene therapies in sickle cell disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "When combined with the seven years of Orphan Drug Designation market exclusivity that we were granted upon FDA approval of APHEXDA beginning last September, and five years of exclusivity across all indications as a New Chemical Entity, we have a broad set of IP protections that we believe will allow us to maximize the value of this important molecule for our company and shareholders for years to come."
Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx 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; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
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Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-strengthens-intellectual-property-estate-with-notice-of-allowance-for-us-patent-covering-method-of-manufacturing-motixafortide-bl-8040-suitable-for-large-scale-production-302078254.html
SOURCE BioLineRx Ltd.
1.3999+0.0699 (+5.2556%)
As of 01:04PM EST. Market open.
Methinks the word has been brought
to His ears and attention!
BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024
https://finance.yahoo.com/news/biovie-ne3107-demonstrates-potential-improvements-130000143.html
0.6200+0.0781 (+14.4123%)
As of 10:40AM EST. Market open.
Sparks of optimism?
Perhaps:
Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada
https://finance.yahoo.com/news/fite-broadens-strong-intellectual-property-120000915.html
Patent has already been issued in other major markets including the U.S., EU, Japan and China
PETACH TIKVA, Israel, February 28, 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 Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company’s two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary endpoint.
Can-Fite’s Namodenoson, is currently out-licensed for the treatment of NASH to the Swiss company Ewopharma for territories in Eastern Europe, to CMS China for the territories of China, HK and Macau, and to the South Korean company CKD for the territory of South Korea. The Company also has a distribution agreement in Canada for its anti-inflammatory drug, Piclidenoson, for the treatment of psoriasis.
"This additional patent in Canada for fatty liver disease adds to our growing IP estate for this high-value indication of the Namodenoson drug candidate. Our strong and broad IP, together with the positive data from the Phase IIa and the drug safety, position it as a promising candidate for the treatment of this liver disease," stated Dr. Ilan Cohn, Can-Fite founder, a recognized business development expert in the medical arena, and also a leading Israeli patent attorney and Partner & co-Founder of Cohn, de Vries, Stadler & Co, Patent and Trademark Attorneys.
The NASH market is expected to reach $24 billion by 2028. According to the American Liver Foundation, between 30-40% of adults in the U.S. have non-alcoholic fatty liver disease, one of the most common causes of liver disease in the U.S. Non-alcoholic steatohepatitis affects up to 5% of Americans, or up to 16 million people and is expected to be most frequent reason for liver transplants in the U.S. by 2030.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
BioLineRx Announces First Patient Dosed in Randomized Phase 2 Combination Clinical Trial Evaluating Motixafortide in First-Line Pancreatic Cancer (PDAC)
https://finance.yahoo.com/news/biolinerx-announces-first-patient-dosed-120000825.html
- Conducted in Collaboration with Columbia University, the CheMo4METPANC Phase 2 trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies compared to chemo alone -
- Gulam Manji, MD, PhD, of Columbia University to present encore pilot phase data at the Immuno-Oncology (IO) 360° Summit on February 29 -
TEL AVIV, Israel, Feb. 28, 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 the first patient has been dosed in the randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC). The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
"Pancreatic ductal adenocarcinoma (PDAC) has had limited responses to traditional immunotherapy, resulting in a poor prognosis for patients and an urgent need for new treatment approaches," said Philip Serlin, Chief Executive Officer of BioLineRx. "We are encouraged by our early pilot data and look forward to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial for patients living with this cancer."
Findings from the single-arm pilot phase of the CheMo4METPANC trial will be shared by Dr. Manji at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New York on Thursday, February 29, 2024. The findings were previously presented during an oral presentation at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts, September 28, 2023. As of July 2023, 7 of the 11 patients (64%) in the pilot phase experienced a partial response (PR) of which 5 (45%) were confirmed PRs at the time of the data cut; one patient experienced resolution of the hepatic (liver) metastatic lesion; and three patients (27%) experienced stable disease, resulting in a disease control rate of 91%.
Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®. Motixafortide is also being evaluated in a Phase 1 clinical trial evaluating motixafortide as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).
About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial's primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.
About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.
About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.
The one problem MDWD has is limited production capacity:
The objective of this agreement is to establish, commission, and validate a cutting-edge, sterile, and GMP-compliant manufacturing facility. The venture aims to increase production capacity significantly, projected to expand to six times the current capacity, aligning with strategic plan to meet the escalating global demand for NexoBrid.
The new facility, equipped with fully operational clean rooms, will be exclusively designed for NexoBrid production. It will comply with stringent regulations from the GMP, FDA, EMA, Israeli Ministry of Health, and relevant Israeli regulatory bodies. An estimated $12 million will be invested in the project, set for completion by mid-2024, with full-scale manufacturing expected to commence in 2025.
From:
https://uk.marketscreener.com/quote/stock/MEDIWOUND-LTD-16056541/news/Mediwound-Ltd-Signs-A-Turnkey-Scale-Up-Agreement-with-Biopharmax-Group-Ltd-44356728/
14.53+0.53 (+3.79%)
As of 11:31AM EST. Market open.
Just broke 52 w/h
BLRX: Poster Presentations
https://finance.yahoo.com/news/blrx-poster-presentations-132700179.html
Mon, February 26, 2024 at 3:27 PM GMT+2
By John Vandermosten, CFA
NASDAQ:BLRX
Subgroup Analyses of Genesis Trial Data at ASTCT & CIBMTR
Washington University School of Medicine’s Zachary Crees, MD and BioLineRx’ (NASDAQ:BLRX) Ella Sorani, PhD descended on San Antonio, Texas last week to participate in poster presentations for the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The tandem meetings took place February 21-24, 2024. Dr. Crees presented a poster entitled Motixafortide Enables Consistent, Robust Hematopoietic Stem Cell Collection (HSC) across Populations with Increased Impaired HSC Mobilization: A Sub-Group Analysis of the Genesis Study. Dr. Sorani shared findings from another poster labeled Prolonged CXCR4 Receptor Occupancy By Motixafortide Following a Single Subcutaneous Injection Is Associated with Extended Mobilization of CD34+ Cells in Peripheral Blood for > 24 Hours. Continue reading for a summary of findings presented at the transplant conferences.
ASCT Stem Cell Collection
Successful autologous hematopoietic stem cell transplant (ASCT) requires a sufficient number of stem cells from peripheral blood to be collected. In many cases, stem cell collection may be difficult due to a number of patient characteristics including age, presence of cytopenias and radiation exposure among other factors. To address problematic collection, the Genesis trial was launched. The Phase III study sought to determine the efficacy of motixafortide and G-CSF combination therapy with G-CSF alone for the mobilization of hematopoietic stem cells.
The primary endpoint of mobilizing more than 6 x 106 CD34+ cells per kg in two apheresis sessions was achieved by 92.5% of subjects in the motixafortide arm compared with 26.2% in the G-CSF arm. The results for patients that presented complicating factors was even more stark between the two arms. Below we provide a comparison of patients with risk factors for poor mobilization who reached collection targets in one apheresis session:
Extended Mobilization of CD34+ Cells
BioLineRx conducted a study to measure in-vitro receptor occupancy, clinical pharmacokinetics and pharmacodynamics of peripheral blood CD34+ cells after motixafortide administration. The assessment was conducted in healthy volunteers and in patients with multiple myeloma. Further aims of the study were to assess associations between apheresis timing and apheresis yield.
The study observed that complete CXCR4 receptor occupancy by motixafortide was observed starting at concentrations as low as 3 nanomolar (nM), with increasing concentrations generating longer receptor occupancy of over 72 hours. Further findings from an examination demonstrated that there was no correlation between the timing of the apheresis procedure and the yield of CD34+ cells within the recommended collection window.
Poster conclusions identified high CXCR4 receptor affinity and slow dissociation rate of motixafortide which result in long receptor occupancy leading to an extended pharmacodynamic effect. CD34+ cells are rapidly mobilized after motixafortide injection, and peak from 12 – 16 hours post administration. 86.3% of patients were able to collect over 6 x 106 CD34+ cells per kilogram in one leukapheresis session. Despite the peak at 12 – 16 hours, there was no correlation between timing of apheresis and cell yield in the 10-hour to 16-hour timepoint following motixafortide injection. The extended pharmacodynamic effect of motixafortide may enable a flexible administration window that allows for leukapheresis to be performed more than 24 hours post administration.
Milestones
? Motixafortide, Phase II (Columbia) PDAC study data release – 2023
? Presentation of GENESIS data at medical meetings & conferences – 2023
? Data published for Phase II PDAC trial – 2H:23
? Motixafortide, Phase I launch in Sickle Cell Disease – 2H:23
? Motixafortide in SCM target action (PDUFA) date – September 2023
? US launch of motixafortide in SCM – 3Q:23
? Gloria Biosciences strategic equity investment – October 2023
? Approval of Asia Licensing Agreement (Gloria) by Israeli Innovation Authority – 4Q:23
? ASH poster presentation: Aphexda in Transplant Centers – December 10, 2023
? Start of Gloria Biosciences’ stem cell mobilization bridge study – 2024
? Start of Gloria Biosciences’ 1st line pancreatic cancer study (motixafortide & zimberelimab) - 2024
? Launch motixafortide and anti-PD-1 combination study - 2024
? Potential initiation of randomized Phase 2 study of AGI-134 – 2024
? Sickle Cell Disease Phase I readout – 2H:24
Summary
BioLineRx presented two posters in San Antonio, Texas at the tandem transplant conferences ASTCT and CIBMTR. The posters provided additional analysis of the Genesis trial and other data which evaluated the use of motixafortide in multiple myeloma patients and healthy volunteers that required an autologous stem cell transplant. The research found that motixafortide was able to produce a high proportion of stem cells especially in patients with risk factors that may otherwise limit collection. A second study was able to show that motixafortide produces durable receptor occupancy at relatively low concentrations of drug which allow for collection over a multi-hour period post motixafortide administration.
While the data provide additional supportive data for motixafortide, the drug’s ability to safely and effectively collect sufficient cells for stem cell transplantation in multiple myeloma patients has been recognized by the FDA, resulting in the product’s approval. BioLineRx is now commercializing motixafortide branded as Aphexda in the United States.
We maintain our valuation of $7.60 per share which recognizes BioLineRx’ commercialization success around the globe for motixafortide in stem cell collection and in various cancer indications.
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3 Top Penny Stocks for 5,000% Upside in 2024 and Beyond
Only extreme speculators need apply
https://investorplace.com/2024/02/3-top-penny-stocks-for-5000-upside-in-2024-and-beyond/
15h ago · By Josh Enomoto, InvestorPlace Contributor
If you want the ultimate in extreme penny stocks, this list should do it.
BioLine (BLRX): BioLine drug discovery specialty aligns with a wide addressable market.
BioLine (BLRX)
A drug development company, BioLine (NASDAQ:BLRX) utilizes its acumen to power novel drug ideas past the bench. From the clinical development process to approval and commercialization, BioLine helps deliver meaningful therapeutics that address critical needs. Per its website, the company seeks to accelerate innovative ideas into the hands of the people who need them most: desperate patients seeking answers to their conditions.
Fundamentally, BioLine benefits from a massive total addressable market. According to Acumen Research and Consulting, the global drug discovery sector reached a valuation of $81.5 billion in 2022. Further, experts believe that the space could be worth $181.4 billion by 2032. If so, that would translate to a compound annual growth rate (CAGR) of 8.5%.
Given that the market capitalization of BLRX stock is only $96 million, it technically enjoys a robust upside pathway. However, the company will need to print something on the top line eventually to satisfy investors.
Still, H.C. Wainwright’s willing to bet on BioLine, rating shares a “buy” with a $21 target. That comes out to almost 1,594% upside. Therefore, BLRX ranks among the penny stocks to consider.
$BLRX Bipolar disorder!
***Correction***
Completely disappointed!
The market is clearly unimpressed!
The increase with robust volume is
indeed a positive sign.
Hope the momentum continues today!
Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®
https://finance.yahoo.com/news/gamida-cell-data-presented-2024-130000249.html
Expanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv)
Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor activity
BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.
“The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “The EAP study provided the opportunity to treat patients after completion of enrollment of the Phase 3 trial and prior to the approval of Omisirge. It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment. Data were consistent with previous studies, showing that patients transplanted with omidubicel had rapid hematopoietic recovery and a low rate of serious infections post-transplant.”
“The Phase 1 data on our natural killer (NK) cell candidate GDA-201 further support the anti-tumor activity of our NAM-enhanced cellular therapy, and today marked the first presentation of study results using our cryopreserved, readily available formulation,” Simantov added.
Reporting on omidubicel’s EAP data, principal investigator Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute, said, “I am highly encouraged by the results in the omidubicel expanded access program. The potential for rapid hematopoietic recovery post-transplant observed with omidubicel could make a meaningful impact on patient health. I am pleased to see that the EAP results are consistent with data from the Phase 3 study.”
Additional details on the presentations are as follows:
Title: Omidubicel-onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP)
Abstract Number: 313
Lead Author: Mitchell E. Horwitz, MD, Stem Cell Transplant Specialist and Professor of Medicine at Duke Cancer Institute
Time: February 22, 6:45-7:45 p.m. CT
Presentation highlights: In this expanded access program (EAP) evaluating outcomes in 29 patients with hematologic malignancies following allogeneic hematopoietic stem cell transplant with omidubicel, outcomes were overall consistent with those from omidubicel’s Phase 3 study. Eligible patients =12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards. Median time to neutrophil and platelet engraftment were 12 and 34 days, respectively. Results were also similar to the Phase 3 study for infection (first grade 2-3 bacterial / invasive fungal infections at 100 days posttransplant: 18%), graft-versus-host-disease (grades 3-4: 19%), disease-free survival (79%) and overall survival (87%). Demographics of transplanted patients were 55% White, 21% Asian, 17% Black, and 7% other, consistent with the Phase 3 trial, in which >40% of the study participants were racially or ethnically diverse. Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.
Title: A Phase I/II Study of GDA-201, Cryopreserved Nicotinamide-Enhanced Allogeneic Natural Killer Cells, in Patients with Relapsed/Refractory B-cell Lymphoma
Abstract Number: 255
Lead Author: Brian C. Shaffer, Associate Professor of Medicine and Head of the Adult Mismatched Donor Sub-Program at Memorial Sloan Kettering Cancer Center in New York
Date and Time: February 22, 6:45-7:45 p.m. CT
Presentation highlights: In this ongoing multicenter Phase 1 study of allogeneic cryopreserved NK cell therapy candidate GDA-201 in patients with relapsed/refractory B-cell CD20 positive non-Hodgkin lymphoma, preliminary data for the first 12 patients were presented. Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant. Patients were treated with doses up to 2x108 cells/kg GDA-201 in combination with rituximab. There were no infusion reactions, dose-limiting toxicities or related serious adverse events. Seven patients exhibited a decrease in tumor burden. Efficacy evaluation using Lugano criteria showed three patients with complete response, two with partial response and two with stable disease. Cytokine release syndrome was reported in two patients (grade 1 and grade 2, respectively). There were no cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease reported. Treatment and evaluation of patients in the fourth cohort of the study at the highest dose level of 2x108 cells/kg is ongoing. Full results are expected in Q1 2024.
Posters are available at: https://www.gamida-cell.com/our-rd/
Protalix BioTherapeutics to Participate in the 2024 BIO CEO & Investor Conference
https://finance.yahoo.com/news/protalix-biotherapeutics-participate-2024-bio-115000410.html
Corporate presentation scheduled for Monday, February 26, 2024 at 1:00 PM ET
CARMIEL, Israel, Feb. 23, 2024 /PRNewswire/ -- 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 will attend and present at the 2024 BIO CEO & Investor Conference taking place February 26-27, 2024 at the New York Marriott Marquis in New York City.
Management is scheduled to give a corporate overview at the BIO CEO & Investor Conference on Monday, February 26, 2024 at 1:00 PM ET at the Plymouth Room and will be available to participate in one-on-one partnering meetings with registered investors and other conference attendees. Following the presentation, a copy will be available under the Event Calendar tab in the Investors section of the Company's website.
Conference attendees that would like to schedule a meeting with the Company's management are encouraged to register through the BIO CEO attendee portal.
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