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Can-Fite Issues Business Update: All Clinical Programs and Business Development Activities Remain Solidly on Track
https://finance.yahoo.com/news/fite-issues-business-clinical-programs-110000836.html
Company management updates about ongoing activities and progress
PETACH TIKVA, Israel, November 01, 2023--(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 confirmed that all of the Company’s clinical and business development activities are ongoing and proceeding by both its Israeli and US based staff.
"Can-Fite remains focused and stronger than ever in our purpose to bring medications to market that improve and save lives. We are working closely with our US based executives, Dr. Bill Kerns and Dr. Michael Silverman, with all our consultants and our collaboration partners in Canada, Europe, the US, China and South Korea. All the investigators participating in the conductance of the clinical studies are working full force and continue patient enrolment for the ongoing advanced clinical studies," stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "Our business development activities are robust and we are receiving a high level of interest, in both Namodenoson and Piclidenoson, which we believe may lead to new pharma partnerships in the near-term."
The Company’s advanced-stage clinical pipeline includes two pivotal Phase III studies: an ongoing trial in advanced liver cancer and a psoriasis study that has been cleared by the U.S. Food and Drug Administration as well as the European Medicines Agency and is expected to commence enrollment shortly. Phase II trials include an ongoing study for steatotic liver disease (SLD), formerly known as NASH, and preparatory work is underway for a Phase IIa trial in pancreatic cancer.
Can-Fite’s latest value-driving developments include its entry into the rare genetic diseases market with Piclidenoson which was found to be effective in pre-clinical studies for the treatment of Lowe Syndrome, an estimated $100 million treatment market in the U.S. alone in which there is no therapeutic treatment option available. Through a partnership with Collaborations Pharmaceuticals, Can-Fite will now utilize artificial intelligence (AI) and machine learning (ML) techniques to identify next-generation A3 adenosine receptor drug agonists and significantly reduce development time and costs of bringing such drugs to market.
Upcoming Earnings Release Paired With Price Target Raise Sends Stock Soaring
https://www.allpennystocks.com/specialreportsus/3404/upcoming-earnings-release-paired-with-price-target-raise-sends-stock-soaring?utm_source=advfn
A New Jersey-based healthcare company turned heads on Tuesday following HC Wainwright & Co. maintaining a buy rating while raising its price target from $7 to $10/share. This report came one day following the company’s announcement that it will be releasing q3 financial results on November 6th.
1.6450+0.1550 (+10.4027%)
As of 01:57PM EDT. Market open.
Volume 393,144
Avg. Volume 565,692
Nice!
0.4501-0.0299 (-6.2292%)
As of 11:37AM EDT. Market open.
Volume 2,155
Avg. Volume 50,882
Complete lack of interest!
BioLineRx entered Exclusive License Agreement to Motixafortide in Asia, advisored by M.S.Q. Ventures
https://finance.yahoo.com/news/biolinerx-entered-exclusive-license-agreement-130000593.html
NEW YORK, Oct. 31, 2023 /CNW/ -- M.S.Q. Ventures ("MSQ") is pleased to announce that its client, BioLineRx Ltd. ("BioLineRx") (NASDAQ/TASE: BLRX), has entered into an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia.
MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)
MSQ Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights into the China market. From understanding key segments of the China healthcare market to identifying and vetting the high potential counterparties to negotiating deals aimed at maximizing value creation, our team focuses on results, prioritizes efficiency to guide our clients through the entire process. (PRNewsfoto/MSQ Ventures)More
The license agreement provides for a $15 million upfront payment and an equity investment of $14.6 million, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones and tiered double-digit royalties on sales.
"Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. GloriaBio has demonstrated a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and this transaction provides us with additional capital to continue our launch plans in the U.S.," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "We are very excited about the swift and successful conclusion of this monumental Asian market licensing agreement. The MSQ team showed remarkable agility and a deep understanding of mutual benefits to both parties right from our initial discussions. MSQ's disciplined deal management ensured a seamless process. Echo, with her visionary leadership, expertise, and impressive execution skills, played a key role in making this collaboration happen."
"We are pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "The MSQ team's great efforts made a huge impact on the closing of this successful transaction in such a short time. The MSQ team provided valuable advice for both sides. We are impressed with the MSQ team's extensive knowledge of financial structures and drug development".
Echo Hindle-Yang, CEO of MSQ, reflecting on the transaction, "We're thrilled about the cross-border collaboration between BioLineRx, the pioneering company behind FDA-approved APHEXDA™ (motixafortide), and GloriaBio, the team behind the PD-1 inhibitor YuTuo® (zimberelimab). This partnership showcases their commitment to advancing global drug development and benefiting patients on a global scale. BioLineRx brings an innovative pipeline, successful FDA approval of APHEXDA™ for stem cell mobilization, strategic collaboration abilities, and a seasoned team to the table. On the other hand, GloriaBio, with their expertise in cancer immunotherapies, clinical development capabilities, and strong commercialization capabilities in Asia, is a formidable partner. The dedication of leaders like Mr. Serlin, Dr. Zhu, and their stellar teams played a pivotal role in swiftly achieving the success of this transformative deal. As part of this momentous partnership, we eagerly anticipate the positive developments ahead, promising an even brighter future for global patients."
About MSQ
M.S.Q. Ventures is a New York-based cross-border advisory firm that bridges the healthcare industries globally by offering our deep knowledge, strong network, and local insights.
info@msqventures.com
Cision
Cision
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SOURCE MSQ Ventures
Cision
Cision
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BioLine RX (BLRX)
https://investorplace.com/2023/10/3-top-penny-stocks-to-make-you-a-millionaire-in-5-years/
BioLine RX (NASDAQ:BLRX) is an Israeli biotech firm with U.S. operations. The company has multiple FDA-approved treatments in its pipeline and more on the way potentially.
Bioline RX received FDA approval for APHEXDA for use in the collection of stem cells in the treatment of multiple myeloma. It is injected and allows most patients to reach a collection goal of more than 6 million hematopoietic stem cells. That improves stem cell transplantation, a standard treatment for multiple myeloma.
So, it is arguably the exact time to consider BLRX stock as it moves into the revenue production stages. The company is developing other drugs for commercialization in areas as diverse as sickle cell anemia and pancreatic cancer. Pancreatic cancer is a particularly lethal form of cancer that is often intractable because it is detected late in many cases. In short, BioLine RX offers immediate upside potential and longer-term upside due to the suite of drugs it continues to develop that address unmet needs.
Can Fite: Namodenoson Inhibits Pancreatic Carcinoma Published in Leading Scientific Journal; Robust anti-Cancer Effect & Molecular Mechanism of Action
https://finance.yahoo.com/news/fite-namodenoson-inhibits-pancreatic-carcinoma-110000122.html
These data support namodenoson as a leading drug candidate to treat patients in an exploratory Phase II clinical study
PETACH TIKVA, Israel, October 30, 2023--(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, inflammatory and liver diseases, today announced that Biomolecules, a peer-reviewed scientific journal focused on function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways", authored by Can-Fite’s CSO Dr. Pnina Fishman and others.
The article includes a summary on the robust inhibition of pancreatic carcinoma growth, both in vitro and in vivo and a definitive description of the molecular mechanism of action. The latter includes de-regulation of three signal transduction pathways known to play a pivotal role in the etiology and pathology of the disease, including the Wnt, NF-kB and the RAS signalling pathway. As a result, death of pancreatic carcinoma cells takes place via apoptosis. This mechanism is highly important since pancreatic carcinoma cells are resistant to the chemotherapy.
The Company is developing an exploratory Phase II study protocol that is designed to allow treatment of patients with pancreatic carcinoma who failed first line therapy. The study objectives will include safety and efficacy of the Namodenoson drug.
Currently, Namodenoson is being evaluated in a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
"We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of Namodenoson against pancreatic carcinoma," stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "We plan to start treating patients very shortly and hope that Namodenoson, with its positive safety and efficacy profile, will prolong life for pancreatic cancer patients."
Protalix BioTherapeutics to Announce Third Quarter 2023 Financial and Business Results on November 6, 2023
Company to host conference call and webcast at 8:30 a.m. EST
https://finance.yahoo.com/news/protalix-biotherapeutics-announce-third-quarter-105000582.html
CARMIEL, Israel, Oct. 30, 2023 /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 third quarter ended September 30, 2023 and provide a business update on Monday, November 6, 2023.
Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments.
Conference Call Details:
Date: Monday, November 6, 2023
Time: 8:30 a.m. Eastern Standard Time (EST)
Toll Free: 1-877-423-9813
Israeli Toll Free: 1-809-406 247
International: 1-201-689-8573
Conference ID: 13741587
Call me™: https://tinyurl.com/2tsadwma
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/362f74wx
Conference ID: 13741587
Corporate Presentation I October 2023
https://www.marketscreener.com/quote/stock/PROTALIX-BIOTHERAPEUTICS--45401/news/Protalix-BioTherapeutics-PLX-Corporate-Presentation-October-2023-45126311/
Investment Highlights
A Strong Foundation To Further Expand Into The Rare Disease Space
Two Approved Drugs in LSDs
Elelyso® (alfataliglicerase in Brazil): FDA approved, commercially marketed drug for Gaucher disease.
Elfabrio® (pegunigalsidase alfa) has been approved for marketing by the European Commission for Fabry disease and by the FDA.
Clinically-Validated Platforms
Proprietary ProCellEx® platform for recombinant protein expression cGMP manufacturing facility successfully inspected and audited by multiple regulatory agencies, including the FDA & EMA.
Strong Partnerships
Chiesi Farmaceutici S.p.A.
Pfizer Inc.
Fundação Oswaldo Cruz (Fiocruz)
Clinical and Regulatory Expertise in Rare Genetic Space
Strong clinical and regulatory expertise for biologics and world-class network of Lysosomal Storage Disorder disease experts.
Development Pipeline
Uricase (PRX-115) for the treatment of severe gout.
Long Acting DNase I (PRX-119) for the treatment of NETs-related diseases, as well as other product candidates, in discovery and preclinical phases.
Revenue-Generating
Multiple revenue streams, including sales to Pfizer, Fiocruz (Brazil) and Chiesi.
Note: cGMP = Current Good Manufacturing Practice.; LSD: Lysosomal Storage Disorders
Corporate Presentation I October 2023
4
Product Pipeline
Recombinant proteins designed to have potentially improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets
Discovery and Preclinical
Phase I
Phase II
Phase III
Marketing Application
Elelyso®
Gaucher Disease
Approved in 23 markets
(taliglucerase alfa)
Elfabrio®
Fabry Disease
Approved (US and EU)
(pegunigalsidase alfa)
Uricase (PRX-115)Severe GoutFinal results PhI (expected 2Q'24)
Long Acting (LA) DNase I
NETs-Related Diseases
(PRX-119)
Research programs
Rare
Disease
Note: Current pipeline candidates are recombinant proteins expressed via our proprietary ProCellEx® system
Corporate Presentation I October 2023
5
Elelyso® for Gaucher Disease
First plant cell derived recombinant protein approved by the FDA
Gaucher Disease
Rare autosomal recessive disorder: affects 1 in 40,000 people
Glucocerebrosidase (GCD) enzyme deficiency resulting in accumulation of glucosylceramide, a lipid, in bone marrow, lungs, spleen, liver, and sometimes brain
Product
• Elelyso (alfataliglicerase in Brazil) is a proprietary, recombinant form of GCD for long-term treatment of patients with a confirmed diagnosis of type 1 Gaucher disease
Based on ProCellEx® platform
Symptoms and Treatment
Possible symptoms include enlarged liver and spleen, various bone disorders, easy bruising and bleeding and anemia
Left untreated, it can cause permanent body damage and decreased life expectancy
Standard of Care: Enzyme Replacement Therapy
Commercial Potential
Approved in 23 markets
Worldwide exclusive license agreement with Pfizer in 2009, amended in 2015 (excluding Brazil)
Sales ~$9.5M in Brazil (FY2022) via Fundação Oswaldo Cruz
Market Share in Brazil: ~25%
1. Approved in 23 markets including the US, Australia, Canada, Israel, Brazil, Russia and Turkey. In 2010, the European Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion but also concluded that the medicine cannot be granted marketing authorization in the EU because of the market exclusivity that had been granted to Vpriv® (Shire), which was authorized in August 2010, for the same condition. The orphan market exclusivity expired in August 2022.
Corporate Presentation I October 2023
6
Elfabrio® for Fabry Disease
Second plant cell derived recombinant protein approved by the FDA
Fabry Disease
Rare X-linked disease: affecting about one in every 40,000 to 60,000 men worldwide
a-galactosidase-Aenzyme deficiency leads to accumulation of the fatty substance globotriaosylceramide (Gb3) in blood and blood vessel walls throughout the body
Product
• Elfabrio (pegunigalsidase alfa): Chemically Modified, Plant Cell Derived, PEGylated, Covalently Linked Homodimer
Approved for marketing by the European
Commission and by the FDA
Symptoms and Treatment
Progressive disease that can lead to renal failure, cardiomyopathy with potentially malignant cardiac arrhythmias, and strokes
Symptoms such as abdominal and neuropathic pain can appear in patients as young as two years old
Standard of Care: Enzyme Replacement Therapy (Replagal® or Fabrazyme®1,2)
Commercial Potential
Fabry: ~$2B (2022) expected to reach ~$3B (2030)
Poised to capture significant global market share (20-25%)
Will potentially be entitled to $150M-$200Mroyalties per year from Chiesi 3
Does not include Galafold®, a small molecule drug indicated for adult Fabry patients with an amenable GLA variant.
Replagal is not approved in the US.
Based on projected 20-25% share of projected market size increase to ~$2.9 billion by 2028.
Corporate Presentation I October 2023
7
Committed Commercial Partner
Global Partnership with
Chiesi Farmaceutici S.p.A.
International research-focused pharmaceuticals and healthcare group with
~$3B in revenue
Operating in 30 countries with over 6,000 employees
Strong sales and marketing partner poised to maximize the market potential of pegunigalsidase alfa as the centerpiece of their new strategic U.S.-based Orphan Drug division
• Committed global partner with experienced sales team
Strategic focus on Rare Disease
Specific expertise in Fabry Disease
Ideally suited to bring Elfabrio® to
patients in Fabry Disease*
*Tiered royalties of 15-35%(ex-US);15-40% (US)
Corporate Presentation I October 2023
8
Growing Focus on High Unmet Needs in Rare Disease Space
Focus on Rare Disease Space
Goal: Within 2 years, 4-6discovery to PhII programs in the pipeline
Rare Genetic
and Non-
Genetic
Rare Genetic
Lysosomal
Storage
Disorders
Our Strategy: Focus on rare diseases space
Both genetic and non-genetic opportunities
Prioritize opportunities with LCM potential
Diseases with high unmet needs
Surrogate endpoints/biomarkers
Systematic Approach to BD&L Screen
Significant in-licensing to build a sustainable portfolio
Open to modalities outside protein (exc. CGT)
Protalix has initiated a large BD&L process to bring in novel opportunities in the rare disease space
Protalix is also reviewing emerging innovative platforms
In-House Discovery Pipeline based on Protein Capabilities
Leveraging ProCellEx platform and PEGylation capabilities for highly innovative opportunities
Reinforce protein capabilities
CGT = Cell and Gene Therapies; LCM = Life cycle management
Corporate Presentation I October 2023
9
Evolving Protalix: Addressing High Unmet Needs in the Rare Disease Space
Leveraging track record of success into other rare diseases
Strategy
Striving for Continued Success in Rare Diseases (genetic and non-genetic)
Track Record of Success in Rare Genetic Space
Initial Success
Protalix Now
Vision
Next Steps
May 2012:
May 2023:
Protalix's 1st approved product
Protalix's 2nd approved product
Within 2 years, 4-6 discovery to PhII programs
Reinforce Protein Discovery
Capabilities
BD&L: Preclinical/Clinical Pipeline
Develop highly innovative rare disease treatments addressing real unmet needs
Building a significant pipeline with innovative rare disease clinical programs
Fully Integrated with End-to-Endcapabilities
Commercial infrastructure to support novel products
Leveraging novel technology platforms with broad potential in rare diseases
Corporate Presentation I October 2023
10
Attachments
Original Link
Original Document
Permalink
Can-Fite to Harness Artificial Intelligence to Develop Novel Anti-Cancer Drugs
Can-Fite signed an agreement with Collaborations Pharmaceuticals, a leading expert in Artificial Intelligence and Machine Learning
PETACH TIKVA, Israel, October 26, 2023--(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 that it entered into an agreement with Collaborations Pharmaceuticals, Inc. (CPI) to develop anti-cancer drugs utilizing artificial intelligence (AI) and machine learning (ML) techniques. This project will aim to develop a next-generation A3 adenosine receptor drug agonists that significantly reduce the development time and cost of bringing such drugs to market.
CPI will utilize, apply and use AI and ML tools, including their MegaSyn generative AI method, to design new molecules with high affinity and selectivity to the A3AR Can-Fite target. CPI will also perform the chemical synthesis of the newly designed molecules with the ultimate goal of developing novel and robust anti-cancer drug candidates. Can-Fite will perform the testing of the biological anti-cancer effects and validate the molecular mechanism of the novel, chemically synthesized drug candidates.
"Our vision is to deliver in silico small molecule drug candidates in a better and faster way to patients via a collaboration with Collaborations Pharmaceuticals. Our accumulated experience of bringing anti-cancer drugs which target the A3AR from lab to patients will be implemented into this AI drug development project," stated Prof. Pnina Fishman, Executive Chairman and CSO at Can-Fite.
"We are delighted that Can-Fite chose our team of experts for this AI-led drug discovery collaboration and look forward to demonstrating what our technology can do," said Sean Ekins, PhD, DSc., CEO and Founder of Collaborations Pharmaceuticals, Inc. We also look forward to complementing their outstanding scientific approach with our integrated technology platform and ability to generate novel and selective molecules."
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.
About Collaborations Pharmaceuticals:
Collaborations Pharmaceuticals, Inc. developed MegaSyn for generative drug design. In addition they have developed Assay Central® software for data curation and machine learning as well as curated model collections such as MegaTox®, MegaTrans® and MegaPredict®. Collaborations Pharmaceuticals, Inc. performs research and development on innovative therapeutics for multiple rare and neglected diseases and consults for pharmaceutical and consumer product companies. For more information, http://www.collaborationspharma.com/
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 30, 2023 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231026204622/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Collaborations Pharmaceuticals, Inc.
Sean Ekins, PhD., D.Sc.
CEO and President
sean@collaborationsPharmaceuticals.com
Business Wire
Free Fall.
Very Sad!
Insiders buying!
Splendid!
Gamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201
https://finance.yahoo.com/news/gamida-cell-reports-preliminary-data-203900267.html
Gamida Cell Reports Preliminary Data From Phase 1 Study Of Natural Killer Cell Therapy Candidate Gda-201
Data show promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma
Full data readout of Phase 1 study expected in Q1 2024
BOSTON, October 16, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231016887701/en/
(Graphic: Gamida Cell Ltd.)
Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab.
Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling.
"We have demonstrated that our nicotinamide (NAM)-modified NK cells have enhanced metabolic fitness, resistance to oxidative stress and potent cytotoxicity, meaning that GDA-201 has the potential for powerful anti-tumor activity," said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. "We are encouraged by the safety and activity observed thus far in our Phase 1 study of cryopreserved GDA-201, which is consistent with results from the Phase 1 study of a fresh formulation of GDA-201 conducted at the University of Minnesota. We look forward to continuing to follow these patients and completing enrollment in our next cohort, and anticipate sharing the full Phase I data in early 2024."
The 10 enrolled patients were diagnosed with diffuse large / high grade B cell lymphoma (6), marginal zone lymphoma (2), follicular lymphoma (1) and mantle cell lymphoma (1). Successive cohorts of patients received dose levels of 2.5x107 cells/kg, 5x107 cells/kg and 1x108 cells/kg of GDA-201 with rituximab after fludarabine/cyclophosphamide lymphodepletion. Two patients treated had cytokine release syndrome (grade 1 and grade 2, respectively). The most common grade 3-4 adverse event was transient neutropenia. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. There was one death from progressive disease.
The NK cells which comprise GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to enhance functionality and phenotype, increase metabolic fitness and reduce oxidative stress. These functional qualities were studied in detail in a recent study published in July 2023 in Science Translational Medicine, which showed that NK cells cultured with NAM had increased energy levels, enhanced ability to arrive at and invade tumors, and an ability to efficiently eradicate malignant cells in the harsh conditions of the tumor microenvironment.
Additionally, the publication includes clinical data from 19 non-Hodgkin lymphoma patients who received the fresh formulation of GDA-201 in a Phase 1 study conducted at the University of Minnesota. GDA-201 exhibited a promising efficacy profile, with an overall response rate of 74% and a complete response rate of 68%. While GDA-201 cells were detected up to 14 days in patients’ blood, the median duration of response was 16 months (range: 5-36 months), suggesting that GDA-201 treatment may prime an endogenous anti-tumor immune response.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
OMISIRGE™ is a trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231016887701/en/
Contacts
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Investor Contact:
Chuck Padala
LifeSci Advisors
Chuck@lifesciadvisors.com
1-646-627-8390
Excellent timing!
Have you checked the NBI index lately?
The XBI?
Look what happened in the past few months.
There is the answer to your question!
The geat positive point in this PR is that
there was no backing from the agreement
as some thought due to the situation in
Israel.
A great sign of confidence.
BioLineRx Announces Closing of Exclusive License Agreement to Motixafortide in Asia and Concurrent Strategic Equity Investment
https://finance.yahoo.com/news/biolinerx-announces-closing-exclusive-license-110000024.html
- License agreement includes $15 million upfront, up to $50 million in potential development and regulatory milestones; up to ~$200 million in potential commercial milestones, and tiered double-digit royalties on sales -
- Gloria Biosciences expected to begin bridging study to support potential approval and commercialization of motixafortide in the territory in stem cell mobilization -
- Gloria Biosciences expected to initiate randomized Phase 2/3 first-line pancreatic cancer clinical trial, evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy -
TEL AVIV, Israel, Oct. 12, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the closing of an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia. Motixafortide is a novel, high-affinity CXCR4 inhibitor that received approval for its first indication in September 2023 by the U.S. Food and Drug Administration (FDA) for stem cell mobilization (SCM) in autologous stem cell transplantation (ASCT) in patients with multiple myeloma. Motixafortide is also being studied for other potential uses in oncologic and hematologic diseases.
The license agreement provides for a $15 million upfront payment (which was received at closing), up to $50 million in potential development and regulatory milestones in China and Japan, and up to $200 million in potential commercial milestones based on defined sales targets. BioLineRx is also eligible to receive tiered double-digit royalties on net sales.
In addition, the transaction included an equity investment of $14.6 million in BioLineRx through the purchase of newly issued American Depositary Shares (ADSs) at a price of $2.136 per ADS in a private placement. No warrants were issued in the transaction. Along with the investment, the purchaser received the right to appoint one representative to the BioLineRx Board of Directors.
Collaboration Details
Under the terms of the license agreement, GloriaBio will be responsible for development and commercialization of motixafortide in Asia initially in SCM. With the recent FDA approval of APHEXDA for this indication, GloriaBio plans to initiate a bridging study to support potential approval and commercialization of motixafortide in the licensed territories in SCM for ASCT in patients with multiple myeloma.
In addition, GloriaBio plans to initiate a Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy. BioLineRx has been developing motixafortide in combination with PD-1 inhibitors and standard of care combination chemotherapies in pancreatic cancer, and recently announced the initiation of a randomized Phase 2 clinical trial sponsored by Columbia University in first-line metastatic pancreatic cancer based on promising preliminary data from a single-arm pilot phase reported on September 29 at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer.
"We are tremendously pleased by the swift closing of this significant licensing agreement for the Asian market, which brings substantial benefits to BioLineRx, and ultimately, to patients, including the advancement of our two leading development programs," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Given GloriaBio's expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. The combined initial investment of nearly $30 million through the upfront payment and equity investment demonstrates a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and provides us with additional capital to continue our aggressive launch plans in the U.S."
"We are very pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio's portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "There are very significant unmet patient needs in pancreatic cancer in Asia, especially in China. We are excited to see the encouraging clinical data of motixafortide in combination with PD-1 inhibitors and chemotherapy in pancreatic cancer and look forward to initiating a Phase 2/3 randomized trial in a first-line pancreatic cancer, as well as investigating additional indications for motixafortide in Asia."
MSQ Ventures served as advisor to BioLineRx on this transaction.
About Pancreatic Cancer in Asia
At nearly 240,000 reported cases in 2022, it is estimated that Asia had the largest number of pancreatic cancer cases globally (496,000 estimated cases worldwide). In China alone, the number of pancreatic cancer cases in 2020 reached approximately 125,000, with a 5-year survival rate of just 7.2%.
About Multiple Myeloma and Autologous Stem Cell Transplantation in Asia
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma (MM), the largest number of MM cases globally. New cases of MM reached over 20,000 in Greater China in 2018, and MM incidence is predicted to increase at an annual growth rate of 2.9%.
Autologous stem cell transplantation (ASCT) can be an important treatment paradigm for a number of blood cancers, including multiple myeloma. In China, ASCTs are included in medical insurance reimbursement, and in 2019, the total number of ASCTs in China reached more than 10,000 for the first time (for comparative purposes, as many as 14,000 ASCTs are performed each year in the U.S.).
*About Zimberelimab (YuTuo®)
Zimberelimab is a fully human anti-PD-1 monoclonal antibody. GloriaBio is developing and commercializing zimberelimab in Greater China, including mainland China, Hong Kong, Macao and Taiwan, where zimberelimab is approved for relapsed or refractory classical Hodgkin's lymphoma and recurrent or metastatic cervical cancer. Arcus Biosciences, and development partner Gilead Sciences, have the exclusive rights to develop and commercialize zimberelimab throughout the world except in Greater China and certain territories.
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.
About Gloria Biosciences
Gloria Biosciences is a commercial stage biopharma company focused on the development and commercialization of novel or highly differentiated immunotherapies and biologics for oncology. Toward the company's ultimate goal of improving accessibility, affordability, and availability for patients with innovation, Gloria Biosciences is striving to build a pipeline of more efficacious and patient-centered treatments to address unmet medical needs, driven by the company's efficient execution of clinical development, proven fast-to-market commercialization ability, world-class GMP-compliant manufacturing capability and global partnerships.
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, the potential benefits of APHEXDA, the timing and execution of the launch of APHEXDA and the plans and objectives of management for future operations and 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 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, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; 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 and the Russian invasion of Ukraine, 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
China
Ying Huang
Gloria Biosciences
IR@gloriabio.com
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-closing-of-exclusive-license-agreement-to-motixafortide-in-asia-and-concurrent-strategic-equity-investment-301954789.html
SOURCE BioLineRx Ltd
MediWound Announces Collaboration with 3M on EscharEx® Phase III Study
https://finance.yahoo.com/news/mediwound-announces-collaboration-3m-escharex-100000502.html
MediWound to join forces with 3M Health Care, world’s largest wound care company in pivotal study for patients with venous leg ulcers
YAVNE, Israel, Oct. 11, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced collaboration with 3M Health Care. 3M Health Care will provide its market leading two-layer compression systems Coban™ 2 and Coban™ 2 Lite to be used during the debridement and wound healing phases of the EscharEx Phase III study.
"In our pursuit of excellence, one primary aim is to ensure consistency across subjects while delivering optimal care throughout the study. 3M Health Care's Coban™ compression systems stand out as global market leaders, and we're pleased to designate them as the standard for our Phase 3 study," commented Ofer Gonen, Chief Executive Officer of MediWound. "Given that compression therapy is pivotal in managing venous leg ulcers (VLUs), it's imperative that we employ top-tier products. With 3M Health Care’s two-layer compression systems, we're confident we're doing just that."
EscharEx is being evaluated for efficacy and safety in the debridement of chronic wounds, with the first indication being VLUs. During the debridement phase, as well as in the wound healing phase of the study, 3M’s two-layer compression systems will be used as standard of care in all study arms, until the wounds reach complete healing.
"We are excited to partner with MediWound on this pivotal Phase III study. Establishing Coban™ 2 and Coban™ 2 Lite as the benchmark in compression therapy underscores the brand's leadership and reinforces its position as the top choice for VLU patients," said Rob Steel, Global Portfolio Director at 3M Health Care. "We anticipate leveraging the comprehensive data from the study to convey to clinicians and payors the clinical and economic advantages of our compression systems."
About EscharEx
EscharEx® (concentrate of proteolytic enzymes enriched in bromelain) is a topical biologic drug applied daily that enzymatically removes nonviable wound tissue, or eschar, in patients with chronic wounds without harming viable tissue. EscharEx has been the subject of 3 successful Phase 2 studies, and is entering into a global Phase III study in early 2024. Co-primary endpoints in the study are incidence of complete debridement and time to complete wound closure. Secondary endpoints include time to complete debridement, incidence of complete granulation tissue, incidence of complete wound closure and wound area reduction.
About 3M
3M (NYSE: MMM) believes science helps create a brighter world for everyone. By unlocking the power of people, ideas and science to reimagine what's possible, our global team uniquely addresses the opportunities and challenges of our customers, communities, and planet. Learn how we're working to improve lives and make what's next at 3M.com/news or on Twitter at @3M or @3MNews.
About MediWound Ltd.
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; the impact of the COVID-19 pandemic, our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director
MediWound Ltd.
LifeSci Advisors, LLC
ir@mediwound.com
daniel@lifesciadvisors.com
Gamida Cell Issues Update on Israel Operations
https://finance.yahoo.com/news/gamida-cell-issues-israel-operations-180000086.html
BOSTON, October 09, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today issued an update on its operations in Israel.
"We remain profoundly saddened by the attacks in Israel this weekend and express our deepest condolences to the people of Israel as they mourn the loss of loved ones and defend themselves," said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. "We have been in touch with our employees in Israel and all are reported safe. We are committed to serving our customers and patients and our manufacturing facility is operational. We thank all our partners and investors who have reached out to express their support. We are continuing to monitor the situation closely and will provide updates as needed."
Gamida Cell issued a statement on Oct. 7 condemning the attacks on Israel and declaring its solidarity with its employees in Israel and the State of Israel, which can be found here.
Yes, on TASE, alas, no data, no PR, but it
certainly had an (delayed) effect in the Naz.
From minus 10% to plus 5% or so is quite
strange. Perhaps we will hear news tomorrow!
Very strange indeed
BioLineRx Ltd. (BLRX.TA)
Tel Aviv - Tel Aviv Delayed Price. Currency in ILA (0.01 ILS)
Follow
Quote Lookup
44.00+7.30 (+19.89%)
At close: 05:30PM IDT
https://finance.yahoo.com/quote/BLRX.TA?p=BLRX.TA&.tsrc=fin-srch
Very strange indeed. BLRX/Naz should follow suit imo
Thank - you, still alive and kicking!
A very sad situation. Just terrible!
MediWound Deploys NexoBrid® for Emergency Supply
https://finance.yahoo.com/news/mediwound-deploys-nexobrid-emergency-supply-113400584.html
YAVNE, Israel, Oct. 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, addresses emergency demand for NexoBrid to treat the mass of burn casualties, inflicted by the war in Israel.
Hospitals and military forces have urgently requested NexoBrid supplies. To address this critical need, MediWound has deployed all its available NexoBrid inventory to aid the substantial number of burn victims.
MediWound remains committed to fulfilling its obligations to our global markets and is implementing measures to ensure supply continuity.
About NexoBrid
NexoBrid® (anacaulase-bcdb) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including in the United States, European Union and Japan, where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
Thank you murocman, i am
still very much alive and kicking!
https://www.facebook.com/photo/?fbid=10159394603229265&set=pob.716974264
(That is me, albeit many many years ago)
Protalix BioTherapeutics Issues Statement Regarding Security Situation in Israel
https://finance.yahoo.com/news/protalix-biotherapeutics-issues-statement-regarding-105000458.html
CARMIEL, Israel, Oct. 9, 2023 /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 issued the following statement by Dror Bashan, Protalix's President and Chief Executive Officer, regarding the current security situation in Israel.
"The Protalix family is horrified by the unconscionable events in Israel over the past weekend which are currently ongoing and the scope of which is yet to be determined. On a personal level, we are heartbroken and pray for the victims as well as their families, friends and other loved ones. At Protalix, we are dedicated to helping our own families, friends and colleagues cope with this devastating situation and to provide them with any support they need.
At the same time, we wish to reaffirm our employees, partners and stockholders that Protalix's operations have not been adversely affected by this situation despite our personal grieving. Hostilities have not taken place where Protalix's facilities are located and we do not anticipate any disruption to the supply of Elfabrio® or Elelyso®. We thank all of our partners and stockholders that have reached out to express their support and best wishes, and are grateful for their continued confidence in Protalix."
Can-Fite to Share its Rare Genetic Disease Lowe Syndrome Novel Treatment with Orphan Drug Japanese Companies
https://finance.yahoo.com/news/fite-share-rare-genetic-disease-110000359.html
PETACH TIKVA, Israel, October 09, 2023--(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, inflammatory and liver diseases, today announced that the Company’s Director of Business Development Dr. Sari Fishman will conduct virtually one-on-one meetings with Japanese companies specializing in the development of Orphan Drugs, at the BioJapan Conference held from October 11-13, 2023, in Yokohama, Japan https://jcd-expo.jp/en/.
Can-Fite signed recently an agreement with Fondazione Telethon for the co-development of Piclidenoson for the treatment of Lowe syndrome based on breakthrough findings of Dr. Antonella De Matteis that the Can-Fite drug Piclidenoson is efficacious in pre-clincial studies in treating Lowe Syndrome. FDA & EMA approvals for rare genetic diseases are faster and require clinical studies with smaller number of patients.
Additional meetings with Japanese companies who are interested in the Oncology and Dermatology Can-Fite’s indications will take place as well.
"The Lowe Syndrome is Can-Fite’s first rare genetic disease indication and I am happy that it raises high interest of Japanese companies who are experts in the orphan drug arena. The conference provides us with the opportunity to present our other developments to lead Japanese pharmaceutical companies," stated Dr. Sari Fishman, Director of Business Development at Can-Fite.
3 Biotech Stocks Offering Great Potential for Gains in October
https://stocknews.com/news/bntx-pbyi-plx-3-biotech-stocks-offering-great-potential-for-gains-in-october/
Stock #1: Protalix BioTherapeutics, Inc. (PLX - Get Rating)
PLX is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx.
On May 18, PLX revealed its eligibility to receive a $20 million milestone payment from Chiesi Global Rare Diseases, a division of the Chiesi Group, following the U.S. FDA approval of ELFABRIO for treating adult patients suffering from Fabry disease. This development represents a pivotal progression for PLX, bolstering its fiscal stability.
PLX’s trailing-12-month asset turnover ratio of 0.91x is 139.6% higher than the industry average of 0.38x. Its trailing-12-month EBIT margin of 18.29% is significantly higher than the industry average of 0.53%.
PLX’s revenue grew at CAGRs 1.5% and 23.6% over the past three and five years, respectively. Its total assets grew at CAGRs of 7.2% and 11.3% over the same periods.
For the fiscal second quarter that ended June 30, 2023, PLX’s total revenue stood at $35.08 million, up 300.7% year-over-year. Its operating income came in at $20.42 million, compared to an operating loss of $5.52 million in the year-ago quarter.
The company’s net income for the period and earnings per share of common stock came in at $19.34 million and $0.21, compared to a net loss for the period and loss per share of common stock of $5.33 million and $0.11 in the year-ago quarter, respectively.
Street expects PLX’s revenue in the fiscal year ending December 2023 to increase 27.3% year-over-year to $60.66 million. Its EPS is expected to come at $0.10. The company surpassed consensus revenue and EPS estimates in each of the trailing four quarters.
The stock has gained 3.9% intraday to close the last trading session at $1.62. Over the past year, it gained 54.3%.
PLX’s robust prospects are reflected in its POWR Ratings. The stock has an overall B rating, equating to Buy in our proprietary rating system.
PLX has an A grade for Value and a B for Growth and Quality. It is ranked #17 within the same industry.
Click here for the additional POWR Ratings for PLX (Momentum, Stability, and Sentiment).
$BLRX is in 'good' company, eg $GMDA, $EVGN,
$PLX, $CGEN to name a few. It seems that the
bio sector in general is not doing too well to say
the least.
I have no educated explanation or reasoning.
What? No hostile takeover by BP?
When did they abandon their plan?
$GMDA We are a proud sponsor of the
@BeTheMatch
Minneapolis Gala.
@BeTheMatch
works every day to save lives through transplant and it was an honor to participate in this evening of inspiration and hope.
#BeTheMatch #Gala #CellTherapy
(Great improvement in PR activities and communications!)
RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study
https://finance.yahoo.com/news/redhill-u-army-announce-opaganibs-110000709.html
- Novel, oral opaganib, delivered a statistically significant increase in survival time (at 150 mg/kg BID) in a U.S. Army-funded in vivo Ebola virus study
- Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having previously shown in vitro benefit in several strains of Ebola virus disease models
- Twice daily administered opaganib has previously demonstrated antiviral benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19; opaganib was also selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development
TEL AVIV, Israel and RALEIGH, NC, Oct. 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that novel, twice daily, oral opaganib[1], 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.
Rekha Panchal, Ph. D of USAMRIID, who led the study, said: "These results represent an alternative strategy of using a host-directed therapeutic with activity in Ebola virus disease in-vivo. Given the unmet medical need and the untapped potential of host-directed antivirals, these results with opaganib, an easy to distribute and administer oral small molecule drug, support its further investigation for use in treating Ebola."
The U.S. Army study tested three doses of opaganib (50, 100 and 150 mg/kg BID), against an inactive vehicle control arm. The in vivo study results showed a statistically significant survival increase in mean (SE) survival time of 11.2 (2.6) days in the 150 mg/kg opaganib group (p=0.0279) compared to a mean (SE) survival time of 5.5 (0.4) days in the inactive vehicle control group. A 30% mice survival was observed in the 150 mg/kg treated group compared to the vehicle control.
"We believe opaganib is the most advanced sphingosine kinase-2 (SPHK2) selective inhibitor in clinical development, and the more we learn about this molecule, its novel host-directed mechanism of action, and its growing safety and tolerability database, the more promising it appears," said Reza Fathi, PhD, RedHill's SVP R&D. "Opaganib has shown its host-directed antiviral potential in clinical and non-clinical studies, warranting further investigation in Ebola and other infectious viral diseases. Working through the inhibition of multiple pathways, anti-inflammatory properties, the induction of autophagy and apoptosis, and disruption of viral replication and potential inhibition of cell entry via simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), we believe opaganib offers a potential breakthrough for fighting a virus capable of causing devastating outbreaks of disease in the countries least equipped to cope with them."
Twice daily administered opaganib has previously demonstrated antiviral benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19 and was selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development.
About Ebola virus disease:
According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses, that are found primarily in sub-Saharan Africa and are known as: Zaire, Sudan, Taï Forest (formerly Côte d'Ivoire) and Bundibugyo. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue), and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. There are currently only two FDA-approved therapies to treat EVD caused by the Ebola virus, species Zaire ebolavirus, in adults and children; Inmazeb™, a combination of three monoclonal antibodies and Ebanga™, a single monoclonal antibody. Both are intravenously infused direct acting monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.
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 recently 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 National Institutes of Health, for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. In an ARS setting, opaganib is thought to exert its protective effects via an anti-inflammatory mechanism of action involving ceramide elevation and reduction of sphingosine 1-phosphate (S1P) in human cells - suppressing inflammatory damage to normal tissue and thus suppressing toxicity from unintended ionizing radiation exposure. It has also been reported in the literature that inhibition of sphingosine kinase 2 promotes the viability and robustness of hematopoietic stem cells, even in the face of radiation damage, supporting increased survival.
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 demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A. 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. Data from the opaganib global Phase 2/3 study has been submitted for peer review and recently published in medRxiv.
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 USAMRIID
Since 1969, USAMRIID has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. The core mission is to protect the warfighter from biological threats, while also investigating disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command.
Gamida Cell to Present Corporate Highlights at 2023 Cell & Gene Meeting on the Mesa
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-120000260.html
Abbey Jenkins, President and Chief Executive Officer, to also participate in the panel "A record setting year for cell and gene therapies – how do we keep the momentum going?"
BOSTON, October 02, 2023--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that Abbey Jenkins, President and Chief Executive Officer, will present its corporate highlights at the annual Cell & Gene Meeting on the Mesa to be held October 10-12 in Carlsbad, California, and livestreamed globally. Ms. Jenkins will also participate in a panel titled "A record setting year for cell and gene therapies – how do we keep the momentum going?" at the event.
During Gamida Cell’s corporate presentation, Ms. Jenkins will share commercial launch updates for Omisirge™ (omidubicel-onlv), the company's allogeneic stem cell therapy, and an overview of the market opportunity.
Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is an annual three-day conference featuring more than 100 presentations by companies highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.
Virtual attendance is available and includes a livestream of Gamida Cell’s presentation and the ability to view all conference sessions on-demand. Please visit https://meetingonthemesa.com for more information.
The following are details regarding Gamida Cell’s presentation at the conference:
Date: Wednesday, October 11
Time: 4:45 – 5:00 p.m. PT
Location: Aseptic Technologies Ballroom, Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011
The following are details regarding Ms. Jenkins’ panel participation at the conference:
Panel: A record setting year for cell and gene therapies – how do we keep the momentum going?
Date: Wednesday, October 11
Time: 3:15 – 4:15 p.m. PT
Location: Aseptic Technologies Ballroom, Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011
Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Savannah Bryant at sbryant@alliancerm.org and interested media should contact Stephen Majors at smajors@alliancerm.org.
Omisirge Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III-IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material
On September 29, 2023, Gamida Cell Ltd. (the “Company”) mailed to its shareholders of record as of the close of business on September 11, 2023 the following materials relating to the Company’s 2023 annual general meeting of shareholders (the “Annual Meeting”):
September 29, 2023
Important Shareholder Meeting
Dear Fellow Shareholders,
As you probably already know, Gamida Cell’s annual general meeting of shareholders is scheduled to be held on Thursday, October 19, 2023, at 10:00am ET. We encourage you to read the proxy statement, vote your shares and attend the meeting as described therein. We’ve included another form of proxy with this letter which will make it easier for you to vote your shares at this very important annual general meeting.
Included among the six ballot items, under Proposal 6 we are seeking approval of an increase in the number of our ordinary shares authorized for issuance in our share reserve, which we believe will provide us with certain flexibility to continue financing the business prudently in order to achieve our two-pronged corporate strategy. Your Board of Directors recommends that you vote in favor of all six of the proposed resolutions and believes we have the right combination of skills and experience to capitalize on the significant opportunity that Omisirge’s recent FDA marketing approval presents.
We would like this opportunity to update you on the progress of our two-pronged approach, which was announced at the end of March 2023 relating to (i) the targeted launch of Omisirge (omidubicel-onlv) in the United States, and (ii) pursuing a strategic partnership or transaction with a bio-pharmaceutical company to expand transplant center onboarding and accelerate patient access to Omisirge.
Targeted Launch of Omisirge
This week we announced that the first patient has received a stem cell transplant with Omisirge. This is a significant milestone for Gamida Cell, marking the advancement of our mission of delivering potentially curative therapies to patients with cancer. We believe this patient is just the first of many who have new hope for a cure, thanks to the availability of Omisirge as a new stem cell transplant donor source.
As we also shared this week, we are pleased with the progress we are making with the launch of Omisirge to date, especially in light of our need to launch with a limited investment and field footprint in order to appropriately manage our cash. Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. We are actively engaged with more than 90% of the top 70 transplant centers, which perform approximately 80% of transplants. Transplanters are identifying patients for whom they intend to use Omisirge as their donor source, with an increasing number of patients being enrolled in Gamida Cell Assist, which indicates the transplanter’s intention to use Omisirge as the donor source.
We have conducted multiple market research studies that confirm the unmet need in the market and associated market share potential of Omisirge with a fully resourced launch. These studies showed that Omisirge has the potential to capture approximately 20% market share at peak, which we estimate could drive over $600 million in net sales within 5 years.
Pursuing a Strategic Partnership or Transaction
We continue to actively engage with potential strategic partners to identify the best strategic and commercial fit to support the early launch of Omisirge and its long-term potential to address critical unmet needs in stem cell transplantation. To ensure that we maintain early launch momentum while pursuing strategic alternatives, we were pleased to share at our second quarter earnings call that we have strengthened our balance sheet significantly, extending our cash runway into Q2 of 2024.
In the spirit of creating value, we continue to be laser focused on successfully executing both prongs of our corporate strategy, and believe it is critical to maintain financial strength and liquidity in order to effectively position the company in a potential transaction. While we are sensitive to shareholder dilution, raising capital through the issuance of shares may be necessary from time to time. As we strive to successfully complete a strategic transaction, we must continue to invest in the launch of Omisirge and our ongoing operations.
We continue to work on your behalf to create shareholder value and appreciate your support.
Sincerely,
Shawn Tomasello
Thank you rwwine!
I am pretty sure sp will increase, although some bumps
will still occur down the road.
It seems to me that $GMDA management are adopting the
AVIS slogan=We (now) try harder!
Enjoy your weekend!
No big difference. Dead money.
A great pity!