Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") is pleased to announce further positive interim results from its study with The Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the "Study"). The Company was provided with data from the Study that indicates the response in a pre-clinical triple negative breast cancer model treated with the combination of Sona's targeted hyperthermia therapy ("THT") and interleukin-2 ("IL-2"), a standard immunotherapy, is statistically significantly superior to results observed from treatment with either agent individually or the control group. This second phase of the Study has documented that, in a cohort of six animals, 66 of treated triple negative breast cancer, the most aggressive and therapy resistant form, mouse tumors bearing gold nanorods and IL-2 responded to the combination therapy, resulting in a flattening of the tumor growth curves, as shown in the below graph. The generation of hyperthermia involved exposing tumors previously injected intratumorally with Sona's gold nanorods and IL-2 to a single dose of near infrared light.
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Sona Nanotech: Leveraging Nanotechnology in Colorectal Cancer Therapy
Sona Nanotech (CSE:SONA, OTCQB:SNANF) advances nanotechnology medicine through its proprietary gold nanorods that promise to change the face of cancer therapy. Sona Nanotech's platform technology leverages uniquely biocompatible gold nanorods (GNRs). Biocompatibility is key to the application of nanotechnology in medicine.
For the past several years, Sona has been working hard to develop and operationalize its biocompatible nanoparticle technology for use in targeted cancer therapy. The company is also developing a targeted cancer therapy, leveraging its proprietary Targeted Hyperthermia Therapy (THT) to directly treat cancer cells.
Sona's GNRs are rod-shaped nanoparticles made of gold and measuring from 10 to 100 nanometers in length. Produced by chemical synthesis, they directly address many of the current limitations of medical nanoparticle technologies. In addition to making them well-suited for cancer treatment, this also unlocks their potential for use in in-vivo medical applications.
Company Highlights
- Canadian nanotechnology company, Sona Nanotech has developed an incredibly promising new technology that leverages uniquely biocompatible gold nanorods.
- The company also plays a key role in the advancement of photothermal medical therapies, particularly enabled by the company's acquisition of Siva Therapeutics.
- This acquisition has allowed Sona to advance the development of Targeted Hypothermia Therapy, addressing many of the risks with current cancer treatments — particularly the damage they can cause to other tissues.
- THT has already proven effective in reducing tumors in small animal studies. Sona's initial target for the technology will be colorectal cancer.
- Rapid diagnostic tests represent the company's other strategic area of focus, including bovine tuberculosis detection and concussion screening.
- Future applications for Sona's technology could include:
- Targeted drug delivery
- Photothermal cosmetic therapy
- Cell imaging
- Additional proprietary testing solutions supported by third-party test development services.
- The company's leadership and board of directors comprise experienced professionals from across the healthcare and biotechnology sectors.
- Sona has a clear roadmap to commercialization of its treatment methodology, starting with a near-term catalyst in large animal studies before moving to a human pilot. It also expects a De Novo pathway for medical devices.
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Sona Nanotech
Overview
Halifax, Nova Scotia-based Sona Nanotech (CSE:SONA, OTCQB:SNANF) is advancing nanotechnology medicine through its proprietary gold nanorods that promise to change the face of cancer therapy
Modern nanotechnology has some very real — and very promising — applications in medicine. It can help make novel diagnostic instruments, imagery and methodologies significantly more effective. It can help physicians deliver treatments and medications with improved safety. And, when combined with other technologies such as predictive analytics and artificial intelligence, nanotechnology can offer a better prognosis, diagnosis and treatment for a multitude of complex conditions.
Most of these use cases are made possible through a material known as a nanoparticle, a near-atomic-scale piece of matter that can be manipulated in a variety of different ways.
Sona Nanotech has, for the past several years, been hard at work developing and operationalizing its biocompatible nanoparticle technology for use in targeted cancer therapy. Biocompatibility is key to the application of nanotechnology in medicine. Because nanomedical devices and materials are still relatively new, both medical and regulatory agencies are still working to understand their impact on the human body.
Sona Nanotech's platform technology leverages uniquely biocompatible gold nanorods (GNRs). Measuring between 10 and 100 nanometres in length, these rod-shaped nanoparticles are produced by chemical synthesis and can be conjugated to a multitude of different molecules. This gives them an impressive range of applications, including antibacterial activity, drug delivery, diagnostic imagery, immunoassay and biosensing.
Currently, Sona Nanotech is developing a targeted cancer therapy, leveraging its proprietary Targeted Hyperthermia Therapy (THT) to directly treat cancer cells. A form of photothermal therapy, THT uses harmless near-infrared light for heat generation. When the non-thermal energy generated by the IR light interacts with Sona's GNRs, it is converted to gentle heat, killing cancer cells and thereby destroying tumors from the inside out. The gentle ~44-degree Celsius heat generated also increases tumor perfusion while also stimulating the immune system. It does no damage to healthy cells, which can tolerate heat of up to ~52 degrees Celsius, eliminating the collateral damage to surrounding healthy tissues that typically result from radiation or chemotherapy treatments.
The first targeted application of this technology will be for colorectal cancer treatment, expected to be enabled through Sona's US$8.65-million acquisition of Siva Therapeutics. Said acquisition will allow Sona to secure a cancer treatment model along with a functional infrared light device. It's a complete game changer, enabling Sona to progress both Siva's technology and its own.
Colorectal cancer is currently the fourth most-diagnosed type of cancer in Canada. Although treatment and diagnosis of the condition have both come a long way in recent years, there is still a long way to go. There are still many barriers to screening and colorectal cancer remains the second leading cause of cancer death worldwide.
Sona is incredibly well-positioned to address these challenges and roadblocks. Its GNR technology has already undergone a multi-stage independent assessment by the U.S. National Cancer Institute’s Nanotechnology Characterization Laboratory. Results, thus far, have been incredibly promising, detecting no microbial contamination or endotoxins.
Sona also recently announced plans to embark on an innovative research partnership with the Giacomantonio Immuno-Oncology Research Group to assess the efficacy of its THT technology for both cancer treatment and the facilitation of systemic immune responses.
It's not just Sona's proprietary technology that makes it so promising, either. The company's management team is incredibly impressive, led by experts from across the healthcare industry. Arguably one of the most notable is chief scientific officer Dr. Len Pagliaro, a professor of bioengineering and medicine with over 24 years of experience in biotech products and licensing.
Its board of directors also include: Mark Lievonen, co-chair of Canada's COVID-19 Vaccine Taskforce; Walter Strapps, CSO of Liberate Bio; and Neil Fraser, who serves on the Canadian Chamber of Commerce's Life Sciences Strategy Council and Health Canada's Advisory Panel on Health Innovation.
Company Highlights
- Canadian nanotechnology company, Sona Nanotech has developed an incredibly promising new technology that leverages uniquely biocompatible gold nanorods.
- The company also plays a key role in the advancement of photothermal medical therapies, particularly enabled by the company's acquisition of Siva Therapeutics.
- This acquisition has allowed Sona to advance the development of Targeted Hypothermia Therapy, addressing many of the risks with current cancer treatments — particularly the damage they can cause to other tissues.
- THT has already proven effective in reducing tumors in small animal studies. Sona's initial target for the technology will be colorectal cancer.
- Rapid diagnostic tests represent the company's other strategic area of focus, including bovine tuberculosis detection and concussion screening.
- Future applications for Sona's technology could include:
- Targeted drug delivery
- Photothermal cosmetic therapy
- Cell imaging
- Additional proprietary testing solutions supported by third-party test development services.
- The company's leadership and board of directors comprise experienced professionals from across the healthcare and biotechnology sectors.
- Sona has a clear roadmap to commercialization of its treatment methodology, starting with a near-term catalyst in large animal studies before moving to a human pilot. It also expects a De Novo pathway for medical devices.
Key Technologies
Gold Nanorods (GNR)
Sona's GNRs are rod-shaped nanoparticles made of gold and measuring from 10 to 100 nanometers in length. Produced by chemical synthesis, they directly address many of the current limitations of medical nanoparticle technologies. In addition to making them well-suited for cancer treatment, this also unlocks their potential for use in in-vivo medical applications.
Highlights:
- Uniquely Biocompatible: Gold nanorod production is typically facilitated through CTAB — a known toxin with the potential to cause cell necrosis. Sona's surfactant uses no CTAB, yet can produce heat in the same way as traditionally manufactured GNRs. This makes the technology potentially more suitable for use within the body.
- Shaped and Stable: Traditional nanoparticles are shaped like spheroids, stars or shells. All three of these shapes have limited surface area, stability and penetration depth. Gold nanorods not only have a larger surface area but also a stabler surface and longer shelf life. They are also available in a variety of lengths and widths.
- High Color Intensity: Sona's GNRs display complex light polarization and novel optical properties, leading to enhanced sensitivity in lateral flow tests. This makes them well-suited for use in diagnostic imaging.
- Potential Use Cases: Other possible applications of Sona's GNRs include:
- Photothermal therapy
- Tumor targeting
- Antibacterial activity
- Drug delivery
- Diagnostic markers for imaging
- Immunoassay and biosensing
- Esophageal cancer
- Bladder cancer
- Prostate cancer
- Pancreatic cancer
- Uterine cancer
Targeted Hyperthermia Therapy
Current cancer treatments are risky, expensive and potentially harmful. Chemotherapy and radiotherapy, for instance, are completely non-selective in cell destruction. Advanced therapies are frequently beyond the price point of most patients, while manual surgery is incredibly risky. Enabled by Sona's transformative acquisition of Siva Therapeutics, the company's Targeted Hyperthermia Therapy represents a potential solution to all three of these problems.
The treatment uses intravenous injection of GNRs to target heat directly to tumors, heating and destroying them from the inside out. Because it's so highly targeted and achieves hyperthermia instead of higher temperature ‘ablation’, it's able to selectively destroy cancer cells with minimal damage to surrounding flesh. As mentioned above, the treatment also uses uniquely biocompatible GNRs.
Colorectal cancer represents the first target application of this new treatment methodology. There is a significant addressable market of patients for which alternatives greatly diminish quality of life.
Highlights:
- Overview: THT consists of two components — gold nanorods and an infrared light source. By heating tumors, it stimulates the immune system, kills cancer cells and shrinks tumors while increasing perfusion.
- Effectiveness: THT is highly effective for several reasons:
- Nanorod concentration in solid tissues such as colorectal tumors is up to seven times higher than in non-tumorous tissue.
- Healthy cells can withstand temperatures of up to 52 degrees Celsius, while cancer cells are destroyed at 44 degrees
- The technology works from the inside of the tumor outwards through heat shock protein synthesis.
- Validation: Siva has had major success in reducing tumors in small animal studies, shrinking cancerous growths in mice in just four weeks. Their materials have also been assessed by the Nanotechnology Characterization Laboratory. Finally, both third-party and in-house testing have confirmed that the company's GNRs are biocompatible.
- Treatment Process: THT is planned to work as follows:
- Step One: Billions of specialized gold nanorods are injected into the patient's bloodstream.
- Step Two: The GNRs concentrate in tissues throughout the body, with their concentration being particularly high in tumors.
- Step Three: Tumors are treated for ten minutes with an infrared light set to the same wavelength as the nanorods.
- Step Four: The IR light energy causes the nanorods to vibrate, producing sufficient heat to kill the cancer cells while leaving healthy cells undamaged.
Diagnostics
In addition to cancer treatment, Sona is also developing a range of GNR-based diagnostics through the use of Lateral Flow Assays. These simple, fast and low-cost diagnostic tools rely on nanoparticles that can be administered directly at the point of care.
Combining them with Sona's GNRs allows for multiple test lines per unit, easier to read results from small samples and potentially greater sensitivity in detecting trace amounts of biomarkers. Currently, it is exploring two primary test prototypes: concussion screening and bovine tuberculosis. The next step for both prototypes involves validation with clinical samples and clinical trials.
Management Team
David Regan - CEO
As the chief executive Officer of Sona Nanotech, David Regan is responsible for business and commercial operations oversight. A strategy consultant and corporate director, Reagan has over 15 years of public company experience in strategy, IR and corporate development. He holds an MBA from INSEAD and a BBA with Hons from St. Francis Xavier University.
Len Pagliaro - CSO
A professor of bioengineering and laboratory medicine at the University of Washington, Dr. Len Pagliaro is the chief science officer of Sona Nanotech, with over two decades of experience with biotechnology products, services and licensing. During his four years at Biolmage, he worked on a commercialization strategy that took the company from concept to a $26-million P&L in just four years.
Darren Rowles - Head of Diagnostics
Darren Rowles has seventeen years' experience with nanoparticle diagnostics with a company that grew nanoparticle sales from $200,000 to $5.5 million with a ~$ 4 million profit. In addition to his role at Sona, he is an advisory board member to Gold Conference and multiple university collaboration projects. Rowles has an MBA from Bath University and a BsC in biomedical science and toxicology from Cardiff Metropolitan University.
Kulbir Singh - Co-founder/Head of GNR R&D
A named author on 35 research papers and two patents, Dr. Kulbir Singh is responsible for GNR development. He holds a PhD. in chemistry from Guru Nanak Dev University. Singh is also co-founder of a science-based consumer products company.
Robert Randall - CFO
A registered CPA, Robert Randall has extensive public company experience as a CFO with organizations including Torrent Capital (CVE:TORR), Antler Gold (CVE:ANTL) and ExeBlock Technology (CSE:XBLK). He holds a bachelor's degree in commerce from St. Mary's University with a chartered accountant designation with Coopers and Lybrand Chartered Accountants dating back to 1987.
Mark Lievonen — Chair
Formerly the president of Sanofi Pasteur, Mark Lievenon serves as co-chair of the Government of Canada's COVID-19 Vaccine Task Force. He is also a director of OncoQuest Pharmaceuticals (KRX: 078590), Biome Grow (CNSX:BIO) and the Gairdner Foundation. Lievenon holds both an MBA and an FCPA.
Walter Strapps — Director
Walter Strapps is the CSO of Liberate Bio, a biotechnology company using machine learning, advanced chemistry and molecular biology techniques to identify novel delivery vehicles for oligonucleotides. He has also served as CEO of Carver Biosciences, chief scientific officer at Gemini Therapeutics (NASDAQ:GMTX) and head of discovery at Intellia Therapeutics (NASDAQ: NTLA), in addition to working with RNA Therapeutics. Strapps holds an MA, M. Phil. and Ph.D.
Neil Fraser — Director
A member of the Canadian Chamber of Commerce's Life Sciences Strategy Council, Neil Fraser is also the former president of Medtronic Canada. He is part of Health Canada's Advisory Panel on Health Innovation, which is chaired by Dr. David Naylor. Finally, Fraser is also a director at CloudMD (CVE: DOC).
Dr. Michael Gross — Director
Dr. Michael Gross is a professor of orthopedic surgery and medical director of the Regional Tissue Bank. He also serves as current director of Fortune Bay (CVE:FOR) and a chair at Boomersplus.
James Megann — Director
James Megann has 25 years of experience in venture capital, capital markets and marketing. As managing director of Numus Financial, he has overseen over $1.5 billion in transactions. He also serves on the board of Torrent Capital.
Sona Nanotech Provides Interim Results of Dalhousie Efficacy Study
Study Principal Investigator and Sona Advisory Board member, Dr. Carman Giacomantonio, comments, "To date, this study demonstrates that Sona's THT therapy shrinks tumors, but early data also suggests that it may increase the efficacy of established therapies based on the synergistic effect it had when combined with IL-2, with results that went well beyond our expectations. Also, as with our first phase of study, in all cases in this second phase we observed tumor shrinkage in distant, untreated tumors consistent with an abscopal response, supporting the hypothesis that THT promotes a systemic immunogenic response which we will continue to study.
In these encouraging initial results, Sona's THT therapy appears to cause cancer cell death in this pre-clinical mouse model, changing the tumor microenvironment and initiating novel, and more effective, tumor-specific immunity."
Sona CEO, David Regan, commented, "We are very encouraged by the evidence indicating that Sona's THT therapy significantly enhances the efficacy of a standard immuno-oncology agent in this mouse model. We look forward to continuing the pre-clinical work necessary to move this into human trials. While current standards of care involving immune therapy can achieve extraordinary results in treating cancer, they work in fewer than half of patients. Sona aims to help these immuno-oncology drugs to work better, enabling them to improve response rates with a view to ultimately increasing survivability for those suffering from cancer."
The Study's next step is to assess the therapy's ability to generate similar results in melanoma and colorectal cancer mouse models and determine the extent to which it serves as an immune modulator for distant, untreated tumors in these cancers. Next, regulatory permission to conduct human trials requires certain satisfactory pre-clinical safety and biocompatibility studies, amongst other potential work. The Company has received guidance on its pre-clinical study plan from both the Food and Drug Administration and its EXCITE International (see press release dated September 5, 2023) panel of senior physicians and payor organization representatives in the United States.
The results discussed in this release are preliminary and have not been subject to peer review. Upon completion, the Company expects that the full Study will be submitted for peer review and scientific journal publication.
Dalhousie Study Interim Results - Tumor Growth in Triple Negative Breast Cancer Mouse Model (N = 6)
To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/5500/205242_b303a8e754ed0853_001full.jpg
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, the Dalhousie study, future publication of study results, Sona's preclinical study plans, the potential impact of the planned studies and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Not for distribution to United States newswire services or for dissemination in the United States
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/205242
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Sona Nanotech Secures Grant Funding to Support Intellectual Property Strategy and Development
Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") announces that it has been approved for funding totaling approximately $40,000 to support the development of its intellectual property portfolio.
The Company is receiving advisory services and up to $24,894 in funding from the National Research Council of Canada Industrial Research Assistance Program ("NRC IRAP") IP Assist program to support the development of an intellectual property strategy for Sona's proprietary gold nanorods for novel targeted drug delivery concepts with a view to securing new patents.
The Company was also approved for funding of approximately $15,000 by Springboard Atlantic under its Atlantic IP Advantage program to implement its IP strategy. Springboard Atlantic is designed to grow Atlantic Canada's innovation economy through collaboration among post-secondary institutions and industry. This funding will support the final drafting and filing of a provisional patent for a novel targeted drug delivery concept being developed by the Company.
Sona CEO David Regan commented, "We appreciate the support of both NRC IRAP and Springboard Atlantic under its Atlantic IP Advantage program. This funding will support the Company in its work developing intellectual property around the significant investments it is making locally in the research and development of cancer applications for our proprietary, uniquely biocompatible gold nanorod manufacturing technology."
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, Sona's preclinical study plans, the potential impact of the planned studies, Sona's product development plans and the potential for future regulatory approvals. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Not for distribution to United States newswire services or for dissemination in the United States
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/204686
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Sona Nanotech Updates on Dalhousie Efficacy Study and New NCL Results
Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company" or "Sona") announces positive interim results from its study with The Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the "Study"). An update received by the Company indicates that all tumors treated within the Study to date with a single Targeted Hyperthermia Therapy ("THT") treatment shrunk within the first 24 hours, with an average reduction in size of 80% compared to matched controls.
Study Principal Investigator, Dr. Carman Giacomantonio, comments, "Our initial assessment documented that in cohorts of seven animals, 7/7 of treated triple negative breast cancer mouse tumors bearing gold nanorods responded with an average reduction in tumor volume of 80% following a single treatment with near infrared light in comparison with untreated 'control' tumors. Interestingly, in all cases we observed responses (tumor shrinkage) in distant, untreated tumors supporting the hypothesis that our observations are consistent with systemic immunogenic responses. This observation will be a significant focus of our research going forward. While we are encouraged by these initial results, there is still significant work to be completed. The studies are designed to enable and identify statistical significance which will be achieved with the completion of the full Study."
The current study assesses the THT efficacy of using Sona's gold nanorods for their combined effect both in generating Targeted Hyperthermia in tumors exposed to near infrared light and as an immune modulator locally and in distant, untreated tumors. This portion of the study will continue to look for elevated immune activation and anti-tumor responses within the mouse models of breast cancer, melanoma and colorectal cancer, using THT alone and in combination with selected immunological agents commonly used in current cancer treatment protocols.
Also, the Company recently received its final report from the U.S. National Cancer Institute's ("NCI") Nanotechnology Characterization Laboratory ("NCL") of its polymer-coated gold nanorods, which included a third assessment of material from Sona, bringing the number of batches of Sona material validated by the NCL to a total of seven. The most recent assessment found improved physical uniformity (with all three batches measuring within 2.1 nanometers in length of each other) and greater purity when compared to past batches. These improvements have been achieved via certain manufacturing process improvements developed with the support of the NCL, and which, in addition to improving purity, may result in reduced costs of scaled manufacturing. This final report also confirmed that the data between all lots of the material that have been assessed are in general agreement.
The studies conducted by NCL included endotoxin testing, hydrodynamic size by DLS, size and shape distribution by TEM, zeta potential, total gold concentration by inductively coupled plasma mass spectrometry (ICP-MS), total and free PEG and total surfactant concentration using RP-HPLC-CAD, and total gold concentration using ICP-MS.
The NCL was established by the National Cancer Institute ("NCI") to accelerate the progress of nanomedicine by providing preclinical characterization and safety testing of nanoparticles. The NCL is a collaborative effort between NCI, the U.S. Food and Drug Administration ("FDA"), and the National Institute of Standards and Technology ("NIST"). It is anticipated that the NCL report could be used in a future potential regulatory application for an investigational device exemption ("IDE") to support the biocompatibility of Sona's gold nanorods.
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, the Dalhousie study, Sona's preclinical study plans, the potential impact of the planned studies and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Sona Nanotech Announces Filing of Provisional Patent Application
Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the "Company" or "Sona") announces that it has submitted a provisional patent application with the United States Patent and Trademark Office (USPTO), for its proprietary photothermal light device, entitled, "ENDOSCOPE WITH EMR OPTICAL FIBER AND THERMAL SENSOR FOR PHOTOTHERMAL THERAPY".
A prototype of Sona's medical laser was engineered in conjunction with Minnetronix Medical to apply non-thermal, 860 nanometer wavelength high intensity infrared laser light. The device has been designed for use with Sona's patented/patent pending biocompatible gold nanorods which efficiently convert the non-thermal light energy into heat. The device has controls to regulate the intensity and duration of the light exposure and to permit a user to monitor and control the temperature generated in tissue. The device is currently being used for the Company's ongoing pre-clinical efficacy study of its Targeted Hyperthermia Therapy cancer treatment at Dalhousie University.
The Company also recently met with a group of leading surgeons and payer representatives in the U.S as part of its second EXCITE International panel discussion. That roundtable evaluation and discussion, together with its recent pre-submission meeting with the U.S. Food and Drug Administration ("FDA"), provided important feedback and guidance to the Company on the development and validation path for its Targeted Hyperthermia Therapy cancer therapy. Sona Nanotech CEO David Regan commented, "Sona's recent roundtable session with its panel of surgeons from leading U.S. academic medical centres and medical payment organizations provided us with invaluable counsel on considerations for both the 'indications for use' for Sona's Targeted Hyperthermia Therapy and the research data that may be required to secure payment codes from payers. This guidance, together with recent feedback received from the FDA,gives us confidence in the appropriateness of our research study pathway and the likelihood of acceptance by physicians and healthcare institutions of our cancer treatment. The Company continues to develop the data on the safety and efficacy of its therapy to support an eventual regulatory submission with its current study at Dalhousie University Medical School."
Finally, the Company recently named Dr. Carman Giacomantonio, MD, MSc., FRCSC, to its Advisory Board. Dr. Giacomantonio is a surgical oncologist and professor of surgery whose research focuses on the mechanism of action of interleukin-2 therapy in the treatment of melanoma and breast and colorectal cancer. Dr. Giacomantonio is the principal investigator for the Company's current pre-clinical efficacy study at Dalhousie University.
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, Sona's preclinical study plans, the potential impact of the planned studies and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Sona Nanotech Grants Options
Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the "Company" or "Sona") announces that that it has granted 1,195,000 incentive stock options under the Company's Stock Option Plan ("Option Plan"), of which 810,000 have been granted to a Directors and Officers. Each option is exercisable into one common share at a price of $0.31 per share and will vest at the rate of 25% every six months. The options will expire five years from the date of grant. All other terms and conditions of the options are in accordance with the terms of the Company's Stock Option Plan.
Contact:
David Regan, CEO
+1-902-536-1932
david@sonanano.com
About Sona Nanotech Inc.
Sona Nanotech, a nanotechnology life sciences company, is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (41-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.
Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications of Targeted Hyperthermia Therapy, Sona's preclinical study plans, the potential impact of the planned studies and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Not for distribution to United States newswire services or for dissemination in the United States
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Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing
Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC) platform
Strong balance sheet with cash, cash equivalents and marketable securities of $611.2 million as of December 31, 2023
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
"We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers."
Recent Business Updates
NUV-868, BD2-selective BETi : Advanced solid tumors
- Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
- Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.
NUV-1511, Drug-Drug Conjugate Platform: Advanced solid tumors
- IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.
Corporate Update:
- Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal's experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights .
Fourth Quarter and Full Year 2023 Financial Results
As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.
For the three months ended December 31, 2023, research and development expenses were $15.4 million, compared to $16.9 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.7 million decrease in third-party costs related to research services and manufacturing driven by the termination of the NUV-422 program offset by a $0.2 million increase in personnel-related costs. Research and development expenses for the year ended December 31, 2023 were $71.3 million compared to $87.8 million for the year ended December 31, 2022.
For the three months ended December 31, 2023, general and administrative expenses were $5.5 million, compared to $7.4 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs, $0.6 million decrease in insurance, a $0.2 million decrease in professional fees, a $0.1 million decrease in taxes and a $0.1 million decrease in miscellaneous expenses offset by $0.2 million increase in legal fees, and a $0.2 million increase in occupancy. General and administrative expenses for the year ended December 31, 2023 were $28.5 million compared to $31.9 million for the year ended December 31, 2022.
For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share. This compares to a net loss of $20.8 million, or $(0.10) per share, for the comparable period in 2022. Net loss for the year ended December 31, 2023 was $75.8 million compared to $104.2 million for the year ended December 31, 2022.
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio's proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com .
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio's product candidates and the expected initiation of a Phase 1/2 study for NUV-1511 in the first half of 2024. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K to be filed with the SEC on February 29, 2024, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
Nuvation Bio Inc. and Subsidiaries | |||||||
Consolidated Balance Sheets | |||||||
December 31, | |||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 42,649 | $ | 101,099 | |||
Prepaid expenses | 1,519 | 3,819 | |||||
Marketable securities available-for-sale, at fair value | 568,564 | 559,915 | |||||
Interest receivable on marketable securities | 3,702 | 2,485 | |||||
Total current assets | 616,434 | 667,318 | |||||
Property and equipment, net | 717 | 894 | |||||
Lease security deposit | 141 | 138 | |||||
Operating lease right-of-use assets | 3,605 | 3,791 | |||||
Other non-current assets | 587 | — | |||||
Total assets | $ | 621,484 | $ | 672,141 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,209 | $ | 2,139 | |||
Current operating lease liabilities | 1,972 | 1,206 | |||||
Accrued expenses | 9,793 | 9,816 | |||||
Total current liabilities | 13,974 | 13,161 | |||||
Warrant liability | 353 | 850 | |||||
Non-current operating lease liabilities | 2,035 | 3,054 | |||||
Total liabilities | 16,362 | 17,065 | |||||
Stockholders' equity | |||||||
Class A and Class B common stock and additional paid in capital, $0.0001 par value per share; | |||||||
1,060,000,000 (Class A 1,000,000,000, Class B 60,000,000) shares authorized as of December 31, 2023 | |||||||
and December 31, 2022, respectively; 219,046,219 (Class A 218,046,219, Class B 1,000,000) and | |||||||
218,632,699 (Class A 217,632,699, Class B 1,000,000) issued and outstanding as of December 31, 2023 | |||||||
and 2022, respectively | 947,745 | 927,604 | |||||
Accumulated deficit | (342,804 | ) | (267,002 | ) | |||
Accumulated other comprehensive income (loss) | 181 | (5,526 | ) | ||||
Total stockholders' equity | 605,122 | 655,076 | |||||
Total liabilities and stockholders' equity | $ | 621,484 | $ | 672,141 |
Nuvation Bio Inc. and Subsidiaries | |||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 15,351 | $ | 16,871 | $ | 71,289 | $ | 87,815 | |||||||
General and administrative | 5,480 | 7,464 | 28,533 | 31,919 | |||||||||||
Total operating expenses | 20,831 | 24,335 | 99,822 | 119,734 | |||||||||||
Loss from operations | (20,831 | ) | (24,335 | ) | (99,822 | ) | (119,734 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 7,023 | 3,523 | 24,611 | 7,448 | |||||||||||
Investment advisory fees | (260 | ) | (225 | ) | (949 | ) | (872 | ) | |||||||
Change in fair value of warrant liability | 237 | 321 | 497 | 10,187 | |||||||||||
Realized gain (loss) on marketable securities | 44 | (129 | ) | (139 | ) | (1,228 | ) | ||||||||
Total other income (expense), net | 7,044 | 3,490 | 24,020 | 15,535 | |||||||||||
Loss before income taxes | (13,787 | ) | (20,845 | ) | (75,802 | ) | (104,199 | ) | |||||||
Provision for income taxes | — | — | — | — | |||||||||||
Net loss | $ | (13,787 | ) | $ | (20,845 | ) | $ | (75,802 | ) | $ | (104,199 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.06 | ) | $ | (0.10 | ) | $ | (0.35 | ) | $ | (0.48 | ) | |||
Weighted average common shares outstanding, basic and diluted | 218,993 | 218,497 | 218,880 | 216,721 | |||||||||||
Comprehensive loss: | |||||||||||||||
Net loss | $ | (13,787 | ) | $ | (20,845 | ) | $ | (75,802 | ) | $ | (104,199 | ) | |||
Other comprehensive loss, net of taxes: | |||||||||||||||
Change in unrealized gain (loss) on available-for-sale securities, net | 3,479 | 2,591 | 5,707 | (4,341 | ) | ||||||||||
Comprehensive loss | $ | (10,308 | ) | $ | (18,254 | ) | $ | (70,095 | ) | $ | (108,540 | ) |
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Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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Nuvation Bio Announces Appointment of Dr. Robert Mashal to its Board of Directors
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced the appointment of Robert Mashal, M.D. to its Board of Directors.
"We are delighted to have Dr. Mashal join our Board of Directors," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Robert is a seasoned biotech industry veteran and his experience as an investor, operator, and medical oncologist will provide us with valuable insights. We look forward to working with Robert to advance Nuvation's pipeline."
"Nuvation Bio is at the forefront of developing therapeutic candidates to treat the unmet need in oncology, highlighted by the company's novel drug-drug conjugate platform," said Robert Mashal, M.D. "I am excited to leverage my past experiences to help the Board and management bring innovative oncology therapeutics to patients."
Robert currently serves as a consultant to the life sciences industry. Previously, he was the Global Head of Strategy for the Immunology and Oncology franchises at Sanofi. Robert has worked as CEO of NKT Therapeutics and Alinea Pharmaceuticals, two venture capital backed life sciences firms. He was a partner at Boston Millennia Partners, a private equity firm, where he was on the Board of Directors of Glycofi, Cardiomems, and Sapphire Therapeutics. He served as a Program Executive at Vertex Pharmaceuticals, where he was on the Joint Steering Committee for the Vertex-Novartis kinase collaboration. He was also a consultant at McKinsey and Company. Prior to McKinsey, Dr. Mashal was a board-certified medical oncologist and received his training in internal medicine at the University of California, San Francisco, and in oncology at the Dana-Farber Cancer Institute. Dr. Mashal received his B.A. and M.D. degrees from Johns Hopkins University.
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio's proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240108092018/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors
NUV-1511 is the first clinical candidate from the company's novel drug-drug conjugate platform
Company anticipates initiating a Phase 1/2 clinical study of NUV-1511 in 1H 2024
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company's novel drug-drug conjugate (DDC) platform.
"This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study."
The dose escalation portion of the Phase 1/2 study will initially evaluate safety and tolerability, and explore the potential for clinical efficacy, in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu ® and/or Trodelvy ® per approved FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC).
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio's proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com .
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio's product candidates, the ability of Nuvation Bio's proprietary DDC platform to design potent oncology candidates, and Nuvation Bio's plans to initiate a Phase 1/2 study for NUV-1511 in 1H 2024. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on November 2, 2023, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240108286005/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
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NanoXplore Receives TSX Approval for Normal Course Issuer Bid
NanoXplore Inc. (TSX: GRA) ("NanoXplore" or the "Corporation") is pleased to announce that the Toronto Stock Exchange (TSX) has approved the Corporation's request to adopt a normal course issuer bid (NCIB) program, through which NanoXplore may purchase, for cancellation, up to 5,936,205 common shares or approximately 5% of the public float (consisting of 118,724,119 common shares as of November 22, 2023, out of the 169,378,431 common shares issued and outstanding). The Corporation may purchase shares under the NCIB over a period of twelve months commencing on December 1, 2023 and ending November 30, 2024, when the bid expires. NCIB purchases are through the facilities of the TSX and certain Canadian Alternative Trading Systems and the price for any repurchased shares will be the prevailing market price at the time of the acquisition.
All common shares purchased by the Corporation will be cancelled. The number of shares repurchased on any given day may not exceed 14,011 common shares, which is equal to 25% of the average daily trading volume on the TSX for the six-month period ending October 31, 2023 except where purchases are made in accordance with the "block purchase exception" of the TSX rules. The average daily volume for this period was calculated in accordance with the rules of the TSX and is equal to 56,045 common shares.
The Corporation's Board of Directors believes that the purchase by the Corporation of its own common shares may, in appropriate circumstances, be a responsible investment of funds on hand.
The extent to which NanoXplore repurchases its shares and the timing of such repurchases will depend upon market conditions and other corporate considerations, as determined by NanoXplore's management team. The Corporation will use funds from its existing cash balances to purchase the shares.
ABOUT NanoXplore
NanoXplore is a graphene company, a manufacturer and supplier of high-volume graphene powder for use in transportation and industrial markets. Also, the Corporation provides standard and custom graphene-enhanced plastic and composite products to various customers in transportation, packaging, electronics, and other industrial sectors. The Corporation is also a silicon‑graphene-enhanced Li-ion battery manufacturer for the Electric Vehicle and grid storage markets. NanoXplore is headquartered in Montreal, Quebec with manufacturing facilities in Canada, the United States and Europe.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements and forward-looking information (together, "forward-looking statements") within the meaning of applicable securities laws. All statements, other than statements of historical facts, are forward-looking statements, and subject to risks and uncertainties. All forward-looking statements are based on our beliefs as well as assumptions based on information available at the time the assumption was made and on management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors deemed appropriate in the circumstances. No assurance can be given that these assumptions and expectations will prove to be correct. Forward-looking statements are not facts, but only predications and can generally be identified by the use of statements that include phrases such as "anticipate", "believe", "continue", "could", "estimate", "foresee", "grow", "expect", "plan", "intend", "forecast", "future", "guidance", "may", "predict", "project", "should", "strategy", "target", "will" or similar expressions suggesting future outcomes.
Forward-looking information is not a guarantee of future performance and involves a number of risks and uncertainties. Such forward-looking information necessarily involves known and unknown risks and uncertainties, including the relevant assumptions and risks factors set out in NanoXplore's most recent annual management discussion and analysis filed on SEDAR+ at www.sedarplus.ca , which may cause NanoXplore's actual results to differ materially from any projections of future results expressed or implied by such forward-looking information. These risks, uncertainties and other factors include, among others, the uncertain and unpredictable condition of global economy. Any forward-looking information is made as of the date hereof and, except as required by law, NanoXplore does not undertake any obligation to update or revise any forward–looking statement as a result of new information, subsequent events or otherwise.
Forward-looking statements reflect management's current beliefs, expectations and assumptions and are based on information currently available to management. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve known and unknown risks and uncertainties and other factors that could cause actual results to differ materially from those contemplated by such statements.
No securities regulatory authority has either approved or disapproved the contents of this press release.
For further information, please contact:
Pedro Azevedo
Chief Financial Officer
pedro.azevedo@nanoxplore.ca
Tel: 1 438 476-1973
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NanoXplore Unveils a Large-Scale Dry Process for Manufacturing of Graphene: An Improvement for Cost Competitiveness and Scalability
NanoXplore Inc. ("NanoXplore" or "the Corporation") (TSX: GRA and OTCQX:Â NNXPF), a world-leading graphene company, proudly announces an interesting achievement in graphite exfoliation with the successful development of a novel dry graphene manufacturing process.
The dry process centers on an advanced exfoliation technology with innovative media that enables high yield exfoliation without the introduction of impurities.
The fusion of NanoXplore's strong intellectual property portfolio and the strategic patents acquisition of XG Sciences has yielded in this significant advancement in graphene production. The amalgamation of eight different patents registered and/or granted in Australia, Canada, United States, Taiwan, China, and South Korea together with NanoXplore's knowledge and experience deliver a graphene with a mix of performance and cost-effectiveness. The research and development related to this process started a decade ago with an investment of nearly $40M to date by NanoXplore and XG Sciences.
NanoXplore's novel dry graphene manufacturing process has several benefits compared to the traditional liquid exfoliation methods. In terms of capital expenditures, dry manufacturing process delivers nearly 50% reduction versus liquid exfoliation process. According to the Corporation's current estimation, a net 8 000 metric tons capacity requires only $20M in capital expenditures, with a quarter of the current square footage required as opposed to liquid exfoliation process.  NanoXplore has secured key suppliers, ensuring a robust supply chain for the main equipment. Equipment procurement is streamlined with off-the-shelf solutions, with an estimated lead time of 8-12 months. The Corporation is planning to start purchasing the equipment during 2024 calendar year.
NanoXplore's novel dry graphene manufacturing process could bring the Corporation within cost parity with traditional carbon additives such as carbon black. The cost reduction results primarily from using low grade waste graphite (which is derived from graphite anode production process) as feedstock. Furthermore, it is highly scalable and operates on a continuous basis, streamlining production efficiency. Superior processability and long-term performance of dry-processed graphene offers investors a more attractive proposition and will expand the Corporation's total addressable market and accelerates commercial adoption of graphene.
With granted patents already secured, this proprietary technology boosts some key physical properties in polymers by 20% compared to existing products for applications with over 20-yr longevity requirements. The technology finds potential applications in batteries and lightweight composites, enhancing its appeal in cutting-edge industries. This new manufacturing process also opens doors to a myriad of applications, including plastic pipes, geosynthetics, recycled plastics, concrete, drilling fluids, and insulation foams, among others.
The new dry manufacturing process marks a paradigm shift, substantially reducing the environmental footprint associated with traditional graphite exfoliation methods. This new process addresses environmental concerns associated with water usage, eliminating washing and drying steps that contribute to increased costs and environmental impact.
NanoXplore's CEO, Soroush Nazarpour, expressed enthusiasm about this breakthrough, stating, "Our team's dedication to innovation and sustainability has led to this remarkable achievement. The dry manufacturing process not only underscores our commitment to environmental stewardship but also reinforces NanoXplore's position as the leader in cost-effective, high-performance graphene solutions. This technological advancement reinforces NanoXplore's commitment to pushing the boundaries of what is possible in field of carbon technology and reaffirms its role as an industry pioneer."
About NanoXplore
NanoXplore is a graphene company, a manufacturer and supplier of high-volume graphene powder for use in transportation and industrial markets. Also, the Corporation provides standard and custom graphene-enhanced plastic and composite products to various customers in transportation, packaging, electronics, and other industrial sectors. The Corporation is also a silicon-graphene-enhanced Li-ion battery manufacturer for the Electric Vehicle and grid storage markets. NanoXplore is headquartered in Montreal, Quebec with manufacturing facilities in Canada, the United States and Europe.
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information (together, "forward-looking statements") within the meaning of applicable securities laws. All statements, other than statements of historical facts, are forward-looking statements, and subject to risks and uncertainties. All forward-looking statements are based on our beliefs as well as assumptions based on information available at the time the assumption was made and on management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors deemed appropriate in the circumstances. No assurance can be given that these assumptions and expectations will prove to be correct. Forward-looking statements are not facts, but only predications and can generally be identified by the use of statements that include phrases such as "anticipate", "believe", "continue", "could", "estimate", "foresee", "grow", "expect", "plan", "intend", "forecast", "future", "guidance", "may", "predict", "project", "should", "strategy", "target", "will" or similar expressions suggesting future outcomes.
Forward-looking information is not a guarantee of future performance and involves a number of risks and uncertainties. Such forward-looking information necessarily involves known and unknown risks and uncertainties, including the relevant assumptions and risks factors set out in NanoXplore's most recent annual management discussion and analysis filed on SEDAR+ at www.sedarplus.ca, which may cause NanoXplore's actual results to differ materially from any projections of future results expressed or implied by such forward-looking information. These risks, uncertainties and other factors include, among others, the uncertain and unpredictable condition of global economy, notably as a consequence of the Covid-19 pandemic. Any forward-looking information is made as of the date hereof and, except as required by law, NanoXplore does not undertake any obligation to update or revise any forward–looking statement as a result of new information, subsequent events or otherwise.
Forward-looking statements reflect management's current beliefs, expectations and assumptions and are based on information currently available to management. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve known and unknown risks and uncertainties and other factors that could cause actual results to differ materially from those contemplated by such statements.
No securities regulatory authority has either approved or disapproved the contents of this press release.
For further information, please contact:
Pedro Azevedo
Chief Financial Officer
pedro.azevedo@nanoxplore.ca
Tel: 1 438Â 476-1973
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NanoXplore Reports Results for its Q1-2024
NanoXplore Inc. ("NanoXplore" or "the Corporation") (TSX: GRA and OTCQX:Â NNXPF), a world-leading graphene company, reported today financial results for the three-month period ended September 30, 2023.
All amounts in this press release are in Canadian dollars, unless otherwise stated.
Highlights
- Total revenues of $28,936,031 in Q1-2024 compared to $27,232,525 in Q1-2023, representing a 6% increase;
- Gross margin on revenues from customers of 19.7% in Q1-2024 compared to 11.6% in Q1-2023;
- Adjusted EBITDA* of $170,654 for the advanced materials, plastics and composite products segment offset by -$618,986 for the battery cells segment (VoltaXplore initiative) for a net adjusted EBITDA in Q1-2024 of -$448,332 compared to -$1,977,032 in Q1-2023;
- Total liquidity of $39,581,390 as at September 30, 2023, including cash and cash equivalents of $28,933,670;
- Total long-term debt of $7,498,468 as at September 30, 2023, down by $377,420 compared to June 30, 2023;
- NanoXplore expects total revenues of $130 million for the year ending June 30, 2024.
Overview
Pedro Azevedo, Chief Financial Officer, stated: "The quarter produced some strong results even though our Q1 is traditionally our slowest quarter. We have won some important new business that will start to benefit us in the 2 nd half of calendar 2024 and maintained the margin improvements we have fought to achieve over the last year. While we acknowledge that growth is slowing down as a result of central banks interest rates hikes, our Graphene initiatives are steadily growing and we are well positioned to deliver the returns our shareholders are expecting from us."
Soroush Nazarpour, President & Chief Financial Officer, said: "I am very pleased with the performance of NanoXplore's team as we have been able to significantly improve our gross margin to almost 20% compared to the first quarter of last year. In addition, we announced new contract wins totaling $24M in annual revenues that will contribute positively to our future financial performance. Our graphene enhanced composite light weighting solutions are gaining momentum, and more OEMs are interested in our products. Graphene brings several technical improvements to these products which translates into higher gross margins, well over traditional composite part suppliers. Our focus on margin expansion, including reducing the manufacturing cost of graphene, focusing on high margin applications such as battery materials will further contribute to our financial performance in the years to come. Furthermore, our continued focus on accelerating the market adoption of graphene and graphene enabled products has led us to achieve a major innovation in manufacturing graphene - developing a dry processing method to produce graphene at significantly lower cost. We believe the expected cost reductions achieved via this process will allow us to make NanoXplore competitive to carbon black selling price thus eliminating one of the major obstacles in adoption of graphene.
A. Reporting Segments results
NanoXplore reports its financials in two distinct segments: Advanced materials, plastics and composite products and Battery cells.
Q1-2024 | Q1-2023 | Variation | ||||||
$ | $ | $ | % | |||||
From Advanced materials, plastics and composite products | ||||||||
Revenues | 28,914,101 | 27,232,525 | 1,681,576 | 6 | % | |||
Non-IFRS Measures: | ||||||||
Adjusted EBITDA * | 170,654 | (1,977,032 | ) | 2,147,686 | 109 | % | ||
From Battery cells | ||||||||
Revenues | 21,930 | — | 21,930 | 100 | % | |||
Non-IFRS Measures: | ||||||||
Adjusted EBITDA * | (618,986 | ) | — | (618,986 | ) | (100 | %) |
B. Results of operations variance analysis - Three-month periods
Revenues
Q1-2024 | Q1-2023 | Variation | |||
$ | $ | $ | % | ||
Revenues from customers | 28,706,752 | 27,147,167 | 1,559,585 | 6 | % |
Other income | 229,279 | 85,358 | 143,921 | 169 | % |
Total revenues | 28,936,031 | 27,232,525 | 1,703,506 | 6 | % |
All revenues are coming from the segment of advanced materials, plastics and composite products, except for $21,930 of other revenues [Q1-2023 – Nil] from the segment battery cells.
Revenues from customers increased from $27,147,167 in Q1-2023 to $28,706,752 in Q1-2024. This increase is mainly due to a positive product mix including graphene enhanced products, higher volume, a positive FX impact and price increases partially offset by lower tooling revenues.
Other income increased from $85,358 in Q1-2023 to $229,279 in Q1-2024. The variation is due to grants received for R&D programs.
Adjusted EBITDA
1) From Advanced materials, plastics and composite products
The adjusted EBITDA improved from -$1,977,032 in Q1-2023 to $170,654 in Q1-2024. The variation is explained as follows:
- Gross margin on revenues from customers increased by $2,499,095 compared to Q1-2023 due to higher sales as described above, favourable product mix, improved productivity and cost control; and
- Partially offset by higher administrative expenses (SG&A and R&D) of $513,400 mainly due to additional headcounts and higher wages, including higher accrued variable compensation.
2)Â From Battery cells
The adjusted EBITDA passed from nil in Q1-2023 to -$618,986 in Q1-2024. The variation is explained by the administrative expenses (G&A and R&D) of $640,916 from this new segment.
C. Other
Additional information about the Corporation, including the Corporation's Interim Management Discussion and Analysis for the three-month periods ended September 30, 2023 and 2022 ("MD&A") and the Corporation's unaudited condensed interim consolidated financial statements for the three-month periods ended September 30, 2023 and 2022 (the "financial statements") can be found at www.nanoxplore.ca .
* Non-IFRS Measures
Results of operations may include certain unusual and other items which have been separately disclosed, where appropriate, in order to provide a clear assessment of the underlying Corporation results.
The financial statements and MD&A were prepared using results and financial information determined under IFRS. However, the Corporation considers certain non-IFRS financial measures as useful additional information in measuring the financial performance and condition of the Corporation. These measures, which the Corporation believes are widely used by investors, securities analysts and other interested parties in evaluating the Corporation's performance, do not have a standardized meaning prescribed by IFRS and therefore may not be comparable to similarly titled measures presented by other publicly traded companies, nor should they be construed as an alternative to financial measures determined in accordance with IFRS. Non-IFRS measures include "Adjusted EBITDA".
Webcast
NanoXplore will hold a webcast tomorrow, November 8, 2023, at 8:30 am EDT to review its Q1-2024. Soroush Nazarpour, CEO and President of NanoXplore, and Pedro Azevedo, Chief Financial Officer, will host the event. To access the webcast please click on the link https://edge.media-server.com/mmc/p/w8ckjavr or you can access through our website in the Investors section under Events and Presentations. A replay of this event can be accessed via the above link or on our website.
About NanoXplore
NanoXplore is a graphene company, a manufacturer and supplier of high-volume graphene powder for use in transportation and industrial markets. Also, the Corporation provides standard and custom graphene-enhanced plastic and composite products to various customers in transportation, packaging, electronics, and other industrial sectors. The Corporation is also a silicon-graphene-enhanced Li-ion battery manufacturer for the Electric Vehicle and grid storage markets. NanoXplore is headquartered in Montreal, Quebec with manufacturing facilities in Canada, the United States and Europe.
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information (together, "forward-looking statements") within the meaning of applicable securities laws. All statements, other than statements of historical facts, are forward-looking statements, and subject to risks and uncertainties. All forward-looking statements are based on our beliefs as well as assumptions based on information available at the time the assumption was made and on management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors deemed appropriate in the circumstances. No assurance can be given that these assumptions and expectations will prove to be correct. Forward-looking statements are not facts, but only predications and can generally be identified by the use of statements that include phrases such as "anticipate", "believe", "continue", "could", "estimate", "foresee", "grow", "expect", "plan", "intend", "forecast", "future", "guidance", "may", "predict", "project", "should", "strategy", "target", "will" or similar expressions suggesting future outcomes.
Forward-looking information is not a guarantee of future performance and involves a number of risks and uncertainties. Such forward-looking information necessarily involves known and unknown risks and uncertainties, including the relevant assumptions and risks factors set out in NanoXplore's most recent annual management discussion and analysis filed on SEDAR+ at www.sedarplus.ca, which may cause NanoXplore's actual results to differ materially from any projections of future results expressed or implied by such forward-looking information. These risks, uncertainties and other factors include, among others, the uncertain and unpredictable condition of global economy, notably as a consequence of the Covid-19 pandemic. Any forward-looking information is made as of the date hereof and, except as required by law, NanoXplore does not undertake any obligation to update or revise any forward–looking statement as a result of new information, subsequent events or otherwise.
Forward-looking statements reflect management's current beliefs, expectations and assumptions and are based on information currently available to management. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve known and unknown risks and uncertainties and other factors that could cause actual results to differ materially from those contemplated by such statements.
No securities regulatory authority has either approved or disapproved the contents of this press release.
For further information, please contact:
Pedro Azevedo
Chief Financial Officer
pedro.azevedo@nanoxplore.ca
Tel: 1 438Â 476-1973
News Provided by GlobeNewswire via QuoteMedia
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