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0.4269+0.1051 (+32.6600%)
As of 02:00PM EST. Market open.
Looks serious!
0.3700+0.0482 (+14.9783%)
As of 10:07AM EST. Market open.
Getting better with robust volume.
Will it stick, i wonder?
0.3562+0.0344 (+10.6899%)
As of 10:00AM EST. Market open.
Misleading signs of life again?
MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army
https://finance.yahoo.com/news/mediwound-secures-additional-u-department-120000363.html
Awarded additional $6.7 million to advance NexoBrid as a non-surgical field care solution; R&D project budget increased to $14.4 million
YAVNE, Israel, Dec. 28, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound an additional $6.7 million in non-dilutive funding to develop NexoBrid® as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $14.4 million project budget will advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. Vericel Corporation holds an exclusive license encompassing the commercial and development rights to NexoBrid in North America as set forth in the license agreement between the Company and Vericel.
"We are delighted to further solidify our partnership with the U.S. Department of Defense. The additional funding will enhance our CMC activities, expedite preclinical development, and facilitate the establishment of a GMP compliant aseptic production line for the temperature-stable formulation of NexoBrid," announced Ofer Gonen, Chief Executive Officer of MediWound. "This new award underscores our shared commitment to ensuring NexoBrid's availability for military use and its potential to significantly change the early treatment approach for severe burns."
The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.
About U.S. Army Medical Research and Development Command (USAMRDC)
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical, and biological defense https://mrdc.health.mil/.
Please note, the views expressed in this press release are those of MediWound and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Medical Technology Enterprise Consortium (MTEC)
The Medical Technology Enterprise Consortium is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel. To find out more about MTEC, visit mtec-sc.org.
About MediWound
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 NexoBrid. 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 U.S. food and Drug Administration or 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 product candidates; 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 need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.
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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, 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
1.5600 +0.07 (+4.70%)
Pre-Market: 08:42AM EST
Hopefully sp will hold and increase today!
1.5900+0.1200 (+8.1633%)
As of 10:24AM EST. Market open.
Protalix BioTherapeutics Issues 2024 Letter to Stockholders
https://finance.yahoo.com/news/protalix-biotherapeutics-issues-2024-letter-115000898.html
CARMIEL, Israel, Dec. 26, 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 the following letter from its President and Chief Executive Officer, Dror Bashan, to its stockholders.
Dear Protalix Stockholders,
As we approach the close of a transitional year for our company, I want to take a moment to reflect on our recent accomplishments…accomplishments that are shaping our path going forward. Elfabrio®, our second development candidate produced through our proprietary ProCellEx® plant cell-based protein expression system, was approved for the treatment of adult patients with Fabry disease by both the U.S. Food and Drug Administration and the European Medicines Agency. Approval of Elfabrio marks a significant milestone for our company and, more importantly, brings a new therapeutic option to patients with unmet needs. This achievement is a testament to the tireless efforts of our talented and professional team, and we take great pride in sharing this success with you, our dedicated stockholders.
As Elfabrio has moved from the development stage to being a commercial product, we are taking steps we believe will strengthen our internal operations and improve our production capabilities for two commercial products. We are confident that as the commercialization of Elfabrio continues to develop, it will enable us to improve our capital structure.
Our commercial partner, Chiesi Global Rare Diseases, played a pivotal role in our journey, and I extend my gratitude to Giacomo Chiesi and the entire Chiesi team. Their support has been instrumental in our combined success, and we look forward to further strengthening our relationship in the years to come. Since the approval, Chiesi has launched Elfabrio in the United States, the European Union and the United Kingdom, strategically positioning Elfabrio for success in those markets. Protalix is dedicated to being a valuable resource to Chiesi and facilitating Chiesi's commercial efforts.
We are continuing to make progress on our pipeline programs. We have finished the seventh cohort in the phase I clinical trial of PRX-115, our recombinant PEGylated uricase (urate oxidase) under development for the potential treatment of severe gout. At this time, 56 patients have been dosed in this trial and we anticipate completing the trial in the second quarter of 2024. Progress is also being made in the preclinical development of PRX-119, our plant cell-expressed PEGylated recombinant human DNase I product candidate which we are designing to elongate half-life in the circulation for NETs-related diseases. We look forward to updating you as we advance in the development of these and other product candidates, and as we begin to turn our focus to building a sustainable portfolio of treatments for rare diseases.
I also want to take a moment to acknowledge the challenges our community continues to face given the current situation in Israel. Our hearts are with all those who have been affected so profoundly, including our colleagues, partners and the broader community. We deeply appreciate the impact of these events on both a personal and professional level, and we continue to extend our support to everyone navigating these difficult times.
Looking ahead, the future of Protalix is filled with promise and potential. As we continue to innovate and strengthen our operations, I am confident that our company can deliver impactful solutions for the benefit of patients in need. Our commitment to excellence, coupled with the passion of our team, positions us well for continued growth and success.
In closing, I want to express my sincere appreciation for our employees and our Board of Directors for their ongoing dedication to our mission. I also want to thank you, our stockholders, for your continued confidence and trust in our vision. As we navigate the exciting journey ahead, I am optimistic about Protalix's future and the positive impact we can collectively make in the lives of patients and the broader healthcare community.
Thank you for your continued support. I hope you enjoy the holidays and have a happy new year.
Sincerely,
Dror Bashan, President & Chief Executive Officer
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.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio, our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to our commercialization partner's ability to obtain and maintain reimbursement for Elfabrio, and the extent to which patient assistance programs and co-pay programs are utilized; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers; the likelihood that the FDA, EMA or other applicable health regulatory authorities will approve an alternative dosing regimen for Elfabrio; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with the novel coronavirus disease, or COVID-19, outbreak and variants, which may adversely impact our business, preclinical studies and clinical trials; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; risks relating to changes to interim, topline or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fiocruz with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
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Cision
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SOURCE Protalix BioTherapeutics, Inc.
Thank You. Happy Holidays
and GLTU.
You've probably read my #msg-173475660
My guess is that RDHL obtained Sec permission
to report twice annually, hence my opinion that
the anual report will be issued by Jan/Feb 2024.
Notwithstanding perhaps some partnership is in
the works, if so it would probably be for Talicia.
1.4800+0.2000 (+15.6250%)
As of 01:19PM EST. Market open.
HOD
Any idea how long we will have to wait before we get the results from this phase 1?
A reply today to my request of yesterday:
A very early stage, therefore i do not forsee
a robust impact on sp, however hopefully
it will offset some of the tax selling.
BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease
https://finance.yahoo.com/news/biolinerx-announces-first-patient-dosed-120000575.html
- Proof-of-concept study is initial step toward goal of identifying more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease choosing gene therapy -
TEL AVIV, Israel, Dec. 21, 2023 /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 Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). The proof-of-concept trial, which plans to enroll five patients diagnosed with SCD, is being conducted in collaboration with Washington University School of Medicine in St. Louis and will assess the safety and tolerability of the two regimens.
"Stem-cell based gene therapy has delivered significant progress in the treatment of sickle cell disease; however, identifying novel mobilization approaches that safely and reliably secure the necessary stem cell collection numbers is clinically relevant for patients," said Zachary Crees, MD, principal investigator for the trial, Division of Oncology, Washington University School of Medicine. "This is an exciting area of clinical research with the potential to meaningfully increase patients' access to stem-cell based gene therapies."
Approved gene therapies rely on the collection of significant quantities of CD34+ hematopoietic stem cells to enable therapeutic manufacturing and backup storage. However, available mobilization regimens may not reliably yield desired numbers of HSCs for gene therapy, and the common mobilization agent G-CSF is contraindicated in patients with SCD. Difficulties in obtaining target quantities of HSCs may extend patient treatment journeys and increase patient and caregiver burdens.
"The recent FDA approvals of two gene therapies for sickle cell disease in the U.S. is an exciting development for the sickle cell community, and we are eager to advance clinical research of motixafortide that may potentially lead to additional CD34+ hematopoietic stem cell mobilization options in the future for patients with this condition," said Ella Sorani, PhD, Chief Development Officer at BioLineRx. "We'd like to thank the patients participating in this important collaboration with Washington University who are helping to advance the field's understanding in this area where there is unmet need."
Initial data from this study is expected in the second half of 2024. 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®.
About the Clinical Trial of Motixafortide in Sickle Cell Disease (SCD)
The trial (ClinicalTrials.gov Identifier: NCT05618301) is a safety and feasibility study to evaluate motixafortide (CXCR4 inhibitor) as monotherapy and in combination with natalizumab (VLA-4 inhibitor) as novel regimens to mobilize CD34+ hematopoietic stem cells for gene therapies in SCD. The study plans to enroll five adults with a diagnosis of SCD who are receiving automated red blood cell exchanges via apheresis. The trial's primary objective is to assess the safety and tolerability of motixafortide alone and the combination of motixafortide + natalizumab in SCD patients, defined by dose-limiting toxicities. Secondary objectives include determining the number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis; and determining the kinetics of CD34+ HSPC mobilization to peripheral blood in response to motixafortide alone and motixafortide + natalizumab in SCD patients.
About Sickle Cell Disease
Sickle cell disease (SCD) is one of the most common genetic diseases globally, affecting millions of people throughout the world and disproportionately impacting persons of color. Sickle cell disease arises from mutations in the hemoglobin gene, ultimately leading to the production of abnormally shaped (sickle) red blood cells that tend to stick within blood vessels causing their occlusion. The clinical manifestations of SCD include anemia and blood vessel occlusion which can lead to both acute and chronic pain, as well as tissue ischemia across multiple organ systems (e.g., stroke, heart attack, respiratory failure), ultimately compromising end organ function. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with SCD.
About BioLineRx
BioLineRx Ltd. (NASDAQ: BLRX) (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.
A day of honey, a day of onion.
Today is onion day.
(Translation: Life alternates, one day of honey,
one day of onion. Meaning: Just as you take the
good times, you have to accept the bad ones.)
RDHL has reported H1/23 Financial Results at August 17, 2023.
No Q2 were released, so perhaps RDHL intends to release
full 2023 results? (sometime in Feb 2024?)
I wonder.
In the meantime nice positive news today.
RedHill shares rally 20% on positive data for two antiviral drugs
Dec. 20, 2023 11:06 AM ETRedHill Biopharma Ltd. (RDHL) Stock
By: Val Brickates Kennedy, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) shares rallied 20% in morning trading Wednesday after the company reported encouraging results from a laboratory study of its drug candidates opaganib and RHB-107, also known as upamostat, in the treatment of ebola.
The Israeli biotech company said the study, which was funded by the US Army, showed the drugs demonstrated “robust synergistic effect” when individually combined with the antiviral drug remdesivir, also known as Veklury. The company said the combinations showed “significantly improved viral inhibition” without increasing toxicity.
The combination of opaganib and remdesivir exhibited the greatest synergistic effect, according to the statement.
“The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as remdesivir, to improve treatment outcome, increasing efficacy while maintaining safety,” said Jefferey Kugelman of the US Army Medical Research institute of Infectious Diseases, in the statement.
RedHill added that a US government-backed Phase 2 study of RHB-107 in the treatment of early COVID-19 is set to enroll its first patient in the coming weeks. The study is expected to be completed by the end of 2024.
Dear Shareholders,
We remain steadfast in our commitment to advancing NurOwn as a promising treatment for ALS patients. Recognizing the challenges faced in our recent BLA submission, we are ambitiously pursuing a Phase 3b trial, aligning with our dedication to the ALS community and our goal of making NurOwn commercially available. Despite the setbacks with the ADCOM's unfavorable vote, our focus remains to align with the FDA on a phase 3b trial design, as we acknowledge that this represents the most expedient pathway to approval.
We are exploring various strategies to secure the necessary funding. We intend to seek a Special Protocol Assessment (SPA), which, when agreed with the FDA, could significantly de-risk the regulatory aspects of the NurOwn program. We are very encouraged by the FDA's ongoing engagement, including the opportunity provided by the expedited in-person Type A meeting on December 6, a rare occurrence in today's regulatory environment. We appreciate the Agency's feedback, comments and other regulatory accommodations, signaling its recognition for the unmet need in ALS and its willingness to reach alignment with Brainstorm on our new clinical strategy.
Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.
We believe that agreement on an SPA would open a broad spectrum of financing options for the trial. Concurrently, we are committed to maintaining our NASDAQ listing status. Our strategy focuses on enhancing the value of our assets, thereby garnering market support that is crucial for our stock price to reach its requisite level by April. We prefer this approach over a reverse stock split, as it aligns more closely with our long-term goals and shareholder interests.
We thank you for your continued support. Your faith in our mission fuels our determination to overcome the recent challenges and ultimately deliver groundbreaking treatments that will help patients in need and create value for our stakeholders.
Sincerely,
Chaim Lebovits
President and CEO
BrainStorm Cell Therapeutics Inc
RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola
https://finance.yahoo.com/news/redhill-u-army-announce-opaganib-134500031.html
Investigational drugs opaganib and RHB-107 (upamostat) demonstrate distinct synergistic effect when combined individually with remdesivir, significantly improving potency while maintaining cell viability, in a new U.S. Army-funded and conducted in vitro Ebola virus study
Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs that are easy to administer and distribute, with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants
Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having recently delivered a statistically significant increase in survival time in a separate U.S. Army-funded in vivo Ebola virus study. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment
TEL-AVIV, Israel and RALEIGH, N.C., Dec. 20, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its two novel, oral host-directed investigational drugs, opaganib[1] and RHB-107 (upamostat)[2], demonstrated robust synergistic effect when combined individually with remdesivir (Veklury®)[3], significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.
"These encouraging in vitro results for opaganib and RHB-107 show a distinct synergy in terms of viral inhibition while maintaining cell viability (i.e., not increasing toxicity), when either is added to remdesivir, with opaganib showing the greatest synergistic effect in combination with remdesivir," said Jeffrey Kugelman, Ph.D., Major(P), US Army MSC, Branch Chief Synthetic Biology & Surveillance, Molecular Biology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), who led the bioinformatics analysis of the study. "The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as remdesivir, to improve treatment outcome, increasing efficacy while maintaining safety."
"Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, and these results add to a recent U.S. Army Ebola virus study in which opaganib delivered a statistically significant increase in mice survival time in vivo," said Reza Fathi, Ph.D., RedHill's SVP R&D. "Opaganib and RHB-107 are both novel, oral, host-directed, small molecule investigational drugs with demonstrated activity against multiple viral targets, including COVID-19, and are expected to be effective against emerging viral variants. This, together with their growing safety and tolerability databases, presents a compelling hypothesis for further study of their potential in treating Ebola virus."
Utilizing a checkerboard design to test the study compounds in combination, the study cell lines were pretreated and then infected with Ebola virus. The cells were fixed, washed and subjected to immunofluorescence staining using a virus-specific antibody. The raw data for the combination was analyzed to determine synergistic, additivity or antagonistic effects on viral inhibition while taking into account cell viability.
Twice daily administered opaganib has previously demonstrated 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.
RHB-107 successfully met its U.S. Phase 2 study primary endpoint of safety and tolerability and delivered promising efficacy results, including marked reduction in hospitalization due to COVID-19. RHB-107 was recently accepted for inclusion in the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The 300-patient PROTECT Phase 2 RHB-107 arm, fully funded by non-dilutive external funding sources including the U.S. government[4], has received FDA clearance to start, with the first patient expected to be enrolled in the coming weeks. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024.
About Ebola virus disease:
According to the Centers for Disease Control and Prevention, 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 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).
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 RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash).
In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[5].
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
About USAMRIID
Since 1969, USAMRIID has served as the U.S. Department of Defense's 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.
The Anti-Obesity Effect of Can-Fite’s Namodenoson: Molecular Mechanism of Action in Pre-clinical and Human Studies
https://finance.yahoo.com/news/anti-obesity-effect-fite-namodenoson-120000346.html
Robust support for Namodenoson’s potential development as an anti-obesity drug, a projected $100 billion market by 2030
PETACH TIKVA, Israel, December 20, 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 reported new data on Namodenoson’s anti-obesity mechanism of action.
New data demonstrate that treatment of fat cells (3T3-L1 adipocytes) with Namodenoson leads to modulation of proteins that increase adiponectin level. Adiponectin is a regulator of fat production in the cells, resulting in the inhibition of fat levels. Furthermore, Namodenoson reduced body weight in an experimental animal model of obesity induced by a high fat diet. In a Phase IIa NASH study, in patients treated with Namodenoson, a 2.1% weight loss was observed after 3 months of treatment (Safadi at Al) and a significant decrease in serum adiponectin levels was found.
"These new preclinical data, together with the excellent safety profile of Namodenoson in humans demonstrated to date, serve as robust support for its potential development as an anti-obesity drug," said Pnina Fishman, Ph.D., CSO & Executive Chairman of Can-Fite BioPharma.
The global obesity treatment market is lucrative due to the awareness of a link between chronic diseases and obesity. The World Health Organization reports that obesity has nearly tripled since 1975 and at least 2.8 million people are dying as a results of obesity each year. According to Goldman Sachs Research, the anti-obesity medications market is estimated reached $6 billion on an annualized basis in 2023 and is expected to grow to $100 billion by 2030.
I have NOT asked to be informed privately,
rather that RDHL announces publicly the Q3
results.
Upon my 3rd request over the last 2 weeks, this was the reply:
CGEN - Compugen will be Eligible to Receive $10 Million Milestone Payment upon Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer
https://finance.yahoo.com/news/compugen-eligible-receive-10-million-121000149.html
Compugen to Host Conference Call to Discuss Exclusive License Agreement with Gilead for COM503, Novel Immuno-Oncology Pre-Clinical Program Harnessing IL-18 Biology
https://finance.yahoo.com/news/compugen-host-conference-call-discuss-120500402.html
Conference call today, December 19, 2023, 8:30 AM ET to discuss the license agreement
HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that it will host a conference call at 8:30 AM ET today, to discuss the exclusive license agreement with Gilead announced today, for the development and commercialization of its anti-IL-18 binding protein program including COM503, a pre-clinical potential first-in-class high affinity antibody targeting IL-18 binding protein with potential to treat multiple tumor types.
Conference Call Details
To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen's website, located at the following link.
Following the live webcast, a replay will be available on the Company's website.
Compugen will be Eligible to Receive $10 Million Milestone Payment upon Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer
Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca
HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from AstraZeneca (LSE/STO/Nasdaq: AZN), when the first patient is dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.
"I am delighted to see the advancement of rilvegostomig into Phase 3 by AstraZeneca, a global leader in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "I believe that the progress of the rilvegostomig clinical program in this Phase 3 trial along with the Phase 1 and 2 trials in additional indications, demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902."
About the Compugen-AstraZeneca license agreement
In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described here which Compugen will be eligible to receive on dosing of the first patient in the Phase 3 ARTEMIDE-Bil01 trial, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific products are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.
Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.
Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program
https://finance.yahoo.com/news/gilead-compugen-announce-exclusive-license-120000324.html
– Gilead Will Have Exclusive Rights to Later Stage Development and Commercialization of Anti-IL18 Binding Protein Antibodies with Potential to Treat Various Tumor Types –
– Gilead to Make $60 Million Upfront Payment and $30 Million in a Near Term Milestone Payment with a Total Deal Value of up to $848 Million –
FOSTER CITY, Calif. & HOLON, Israel, December 19, 2023--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, headquartered in Holon, Israel, to exclusively license its potential first-in-class, pre-clinical antibody program against IL-18 binding protein, including the COM503 drug candidate.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231218814564/en/
Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth.
"We are very pleased to add COM503 to our pipeline of investigational immuno-oncology therapies that have the potential to transform care for patients with cancer," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "We believe that this collaboration complements our strategy of developing modalities which promote immune-mediated tumor killing and may enable new combination therapies with programs in our growing oncology portfolio."
"We are delighted to enter into this collaboration with Gilead and believe that Gilead’s confidence in our differentiated approach to harness cytokine biology for cancer therapeutics speaks to the quality of our computational discovery capabilities as well as our ability to translate our novel discoveries into investigational drugs in the clinic and we look forward to working together to bring new treatment options to patients," said Anat Cohen-Dayag, Ph.D., President, and CEO at Compugen. "IL-18 is one of the rare cytokines which is naturally inhibited by an endogenous binding protein, presenting a unique opportunity to use a blocking antibody to increase the local concentrations of IL-18 within the tumor where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines."
Terms of the Partnership
Under the terms of the agreement, Compugen will be responsible for the ongoing pre-clinical development and the future Phase 1 study of COM503. Thereafter, Gilead will have the sole right to develop and commercialize COM503.
Gilead will make Compugen an upfront payment of $60 million and $30 million in a near term milestone payment subject to IND clearance of COM503 expected in 2024. Compugen will also be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million. Compugen will also be eligible to receive single-digit to low double-digit tiered royalties on worldwide net sales.
Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Compugen is expected to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.03 - $0.05.
Buyers in sub $1 selling for tax reasons
IMO.
No bad news i am aware of.
I did not request non public information.
This was my 3rd request for RDHL to
announce Q3 results.
Mind you, RDHL according to sec rules
results should be published one or two weeks
after the last month of each quarter.
Q4 is over in less than 2 weeks time, hence i
guess results for fiscal 2023 will be published
somewhere around 2025?
Ha!
False alarm.
1.3068+0.1668 (+14.6316%)
As of 01:04PM EST. Market open.
Getting better ....
1.2750+0.1350 (+11.8421%)
As of 12:29PM EST. Market open.
Nice uptick on relative robust volume.
Still no Q3 results!
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On December 14, 2023, Gamida Cell Ltd. (the “Company”) entered into a Second Amended and Restated Consulting Agreement, effective December 31, 2023 (the “Amended Consulting Agreement”), with Terry Coelho, the Chief Financial Officer of the Company, pursuant to which Ms. Coelho’s existing Amended and Restated Consulting Agreement, dated May 22, 2023, with the Company was extended through March 31, 2024. The Amended Consulting Agreement provides for Ms. Coelho to be compensated at an hourly rate of $500 for a minimum of 40 hours per week of services specified in the Amended Consulting Agreement. Ms. Coelho is also eligible to earn a retention bonus of $100,000 (the “Retention Bonus”) if she remains continuously engaged with the Company through March 31, 2024. If, prior to March 31, 2024, either Ms. Coelho provides notice of termination without cause, or the Company provides notice of termination for breach and Ms. Coelho fails to cure the breach, then the Retention Bonus will not be paid.
Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan
https://finance.yahoo.com/news/fite-received-fda-positive-response-120000414.html
FDA encouraged the Company to accelerate enrollment of adolescent patients due to Piclidenoson’s good safety profile
There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in children
PETACH TIKVA, Israel, December 18, 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 announced that it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson.
The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite’s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis.
There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease.
Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease.
"We believe Piclidenoson’s oral formulation with its excellent safety profile, combined with its progressive effectiveness over time make it ideally suited for the chronic treatment of psoriasis in adults and children alike," stated Can-Fite VP Drug Development, Dr. William Kerns.
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.canfite.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/20231218865060/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Looks like the volume has all
but dried up.