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NEWS -- Plus Therapeutics to Host Key Opinion Leader Roundtable on ReSPECT™-GBM Trial
Company Management and Principal Investigators to Discuss Trial Data
Webinar Scheduled for Thursday, November 18, 2021 at 4:00 - 5:00 p.m. ET
AUSTIN, Texas, Nov. 03, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that it will host a key opinion leader roundtable discussion on the ReSPECT-GBM trial on Thursday, November 18, 2021, 4:00 to 5:00 p.m. ET.
The webinar will feature a comprehensive discussion about the ongoing ReSPECT-GBM trial including key safety, tolerability, dosing, feasibility and efficacy data. Speakers will include:
FuelPositive Corp. (TSX.V: NHHH) (OTCQB: NHHHF) Defining the Ongoing Disruption Within the Energy, Transportation and Food Sectors
November 2, 2021 at 12:42pm
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Meta-Analysis Results of Single-Agent PV-10® in Stage III Cutaneous Melanoma at Society for Melanoma Research (SMR) 2021
KNOXVILLE, TN, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that results from a meta-analysis of response, survival, and safety data from the Company’s Phase 2 and 3 clinical trials (NCT00521053 and NCT02288897, respectively) and expanded access program (EAP) (NCT01260779) of single-agent cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of Stage III cutaneous melanoma was presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), which was held online from October 28th to 31st.
A copy of the poster presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/SMR-2021-PV-10-in-Stage-III-Melanoma.21Oct2021.pdf.
Highlights of the SMR 2021 presentation:
InvestorNewsBreaks – FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) Inching Closer to a World with Sustainable, Clean Fossil Fuel Replacement
FuelPositive (TSX.V: NHHH) (OTCQB: NHHHF) has achieved several milestones and made strategic investments that bring it even closer to its ultimate goal of providing sustainable, clean energy to reduce carbon emissions. The company, which is pushing for the change from fossil fuels, has appointed André Mech, who will lend his years of experience to the strategic carbon credit and emissions reduction specialist position, helping FuelPositive sell its carbon credits in the same way Tesla does. With the hydrogen economy being at the core of the company’s agenda, FuelPositive is spearheading the modular and scalable carbon-free ammonia industry. “To date, FuelPositive has managed to achieve three main milestones for the 2021 fiscal year: process determination, primary component vendor selection and procurement, and engineering design,” reads a recent article. “Going forward into 2022, the company plans to put systems in place for demonstration projects with partners and ramp up production capability in the early half of the year and start shipping commercial systems in the last quarter of 2022.”
To view the full article, visit https://ibn.fm/B2PRr
About FuelPositive Corporation
FuelPositive is a Canadian growth-stage technology company committed to providing commercially viable and sustainable “cradle to cradle” clean energy solutions, including carbon-free ammonia (“NH3”), for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, economically advantageous/realizable and that leverage existing infrastructure, the company aims to change the course of climate change through practical solutions that can be implemented now. The company’s core technology, carbon-free NH3, takes air, water and sustainable electricity and converts it to a non-polluting chemical for multiple applications, fertilizer for farming, fuel for internal combustion engines and a solution for grid storage. It is being considered as a replacement for fossil fuels and as a key enabler of the hydrogen economy. For more information, visit www.FuelPositive.com.
NOTE TO INVESTORS: The latest news and updates relating to NHHHF are available in the company’s newsroom at https://ibn.fm/NHHHF
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Whales are back!
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Updated Data from Combination Therapy Trial of PV-10® and Keytruda® for Treatment of Checkpoint-Refractory Advanced Cutaneous Melanoma at Society for Melanoma Research (SMR) 2021
Canadian Jenn twitter Account has been suspended!
NEWS -- Plus Therapeutics Announces Presentation of ReSPECT-GBM Trial Dosimetery Data at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting
Data demonstrated Rhenium-186 NanoLiposome (186RNL) provides sustained, localized radiation treatment for over eight days to the tumor with minimal whole brain and body radiation exposure
The analysis of 3D drug distribution and tumor response shows image monitoring is a predictive tool to evaluate delivery and treatment effectiveness
Compared to sealed source brachytherapy, 186RNL offers minimally invasive, convenient delivery
AUSTIN, Texas, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today presented data at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting indicating Rhenium-186 NanoLiposome (186RNL) delivered to patients with recurrent glioblastoma (GBM) through convection enhanced delivery results in predictable distribution and stable retention to the targeted tissues, providing days of sustained, localized radiation treatment to the tumor.
Data from the ePoster titled “Image-guided Rhenium-186 NanoLiposome (186RNL) brachytherapy in the treatment of recurrent glioblastoma: technique, image analysis, dosimetry, and monitoring” demonstrated the following:
NEWS -- FuelPositive Announces Closing of CAD$7 Million Private Placement with U.S. Institutional Investors
/NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES/
TORONTO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTCQB: NHHHF) is pleased to announce it has closed its subscription agreement with certain U.S. institutional investors for gross proceeds of approximately CAD$7 million in a private placement in the United States, comprised of 30,434,784 common shares and warrants to purchase an aggregate of up to 30,434,784 common shares at a purchase price of CAD$0.23 per common share and associated warrant. The warrants have an exercise price of CAD$0.255 per common share and are exercisable until October 28, 2024. The net proceeds of the private placement will be used by the Company to increase the number of available FuelPositive carbon-free ammonia systems to deploy into high profile demonstration projects throughout 2022 and for general corporate purposes.
H.C. Wainwright & Co. acted as the exclusive placement agent for the private placement in the United States. In consideration for coordinating the placement, the Company has paid a cash commission of CAD$560,000 and issued 2,434,783 warrants, each of which have an exercise price of CAD$0.23 per common share and are exercisable until October 28, 2024.
No securities were offered or sold to Canadian residents in connection with the private placement.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release shall not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.
About FuelPositive
FuelPositive is a Canadian growth-stage technology company committed to providing commercially viable and sustainable “cradle to cradle” clean energy solutions, including carbon-free ammonia (NH3), for use across a broad spectrum of industries and applications.
By focusing on technologies that are clean, economically advantageous/realizable and that leverage existing infrastructure, the Company aims to change the course of climate change through practical solutions that can be implemented now.
The Company’s core technology, a modular and scalable carbon-free NH3 system, takes air, water and sustainable electricity and synthesizes it into a non-polluting chemical for multiple applications, including fertilizer for farming, fuel for internal combustion engines and a solution for grid storage. It is being considered as a replacement for fossil fuels and as a key enabler of the hydrogen economy.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://mailbox1@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- Navidea Biopharmaceuticals Announces Resignation of Jed A. Latkin
DUBLIN, Ohio, October 26, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the resignation of Jed A. Latkin as Chief Executive Officer, Chief Financial Officer and Chief Operating Officer of the Company, and as a member of the Board of Directors of the Company, effective October 24, 2021. Mr. Latkin and the Company are discussing the terms of a severance agreement pursuant to his employment contract.
An Office of the CEO including three members of the Company’s Board of Directors has been established to lead the Company on an interim basis while the next Chief Executive Officer of the Company is identified with the assistance of an executive search firm. The Office of the CEO consists of three Board members, including the Chairman, Vice Chairman and Thomas Farb, and the Company’s Senior Vice President and Chief Medical Officer, Michael Rosol, Ph.D., and the Company’s Vice President of Finance and Administration, Erika Eves.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211026006301/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeff Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
Tytan Cybernetics
@NIHKEV
·
2h
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Isopet update!https://twitter.com/radiogel
new Twitter message !
NEWS -- OpRegen® Data Update to Be Featured at 2021 American Academy of Ophthalmology Annual Meeting in Presentation by Michael S. Ip, M.D.
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a clinical study of its lead product candidate, OpRegen®, an investigational retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be featured in a presentation at the 2021 American Academy of Ophthalmology (AAO) 125th Annual Meeting, to be held at the Ernest N. Morial Convention Center, New Orleans, LA (November 12 – 15, 2021). The presentation, “OpRegen Trial: Phase 1/2a Dose Escalation Study of Human Embryonic Stem-Cell Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced AMD,” will be presented on November 13, 2021 at 2:38 pm EDT as part of the Gene and Cell-Based Therapies Session, by Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California - Los Angeles.
In addition to Dr. Ip’s presentation, Lineage also intends to announce updated interim results from the Phase 1/2a study next month, which will include a minimum of 12 months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in Cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts. OpRegen is well-positioned among product candidates in development for dry AMD as the only experimental therapy that has demonstrated an ability to halt or reverse the expansion of geographic atrophy as well as restore layers of retinal tissue in three patients to date. Specifically, outer retinal layer restoration was observed via optical coherence tomography (OCT) and was evidenced by the presence of new areas of retinal pigment epithelium (RPE) monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, all of which were not present at the time of baseline assessment. These findings are suggestive of integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells.
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. The mission of the American Academy of Ophthalmology is to protect sight and empower lives by serving as an advocate for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology. For more information, please visit https://www.aao.org/ or follow the association on Twitter @aao_ophth.
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with geographic atrophy (GA). The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Age-Related Macular Degeneration
AMD is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch's membrane and the retinal pigmented epithelium, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no U.S. Food and Drug Administration, or European Medicines Agency, approved treatment options available for patients with atrophic AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https:?/www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” ‘suggest,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the projected timing of future announcements or presentations of updated or additional data from the Phase 1/2a clinical study of OpRegen, the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211026005496/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
Well, looks like we got a little over 30 days to find out , I have been waiting over three years, and I can wait , holding a lot of shares and I will see this threw . Radio gel is a Great quick and easy cancer-fighting tool .
NEWS -- Innovation Pharmaceuticals' COVID-19 Clinical Trial Topline Results Anticipated to Be Reported the Week of November 8th
WAKEFIELD, MA / ACCESSWIRE / October 25, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today announced the Company anticipates reporting topline results the week of November 8th from its Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). The study data is presently blinded at the data management vendor, with final checks and approvals in progress.
The Company is also pleased to report Brilacidin has been shipped to two academic laboratories for planned in vitro testing of Brilacidin in over 20 acutely infectious viruses, including Ebola, Marburg, Nipah, West Nile and Zika, through a collaboration with U.S. government scientists. The goal of this testing is to further inform the spectrum of Brilacidin's antiviral properties.
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Innovation Pharmaceuticals is developing Brilacidin for the treatment of COVID-19 under U.S. FDA Fast Track designation. A dual-acting inhibitor able to target viral proteins and host factors, while also exhibiting robust anti-inflammatory and antibacterial properties, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with lab testing against other viruses also underway), supporting Brilacidin's development as a broad-spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
A peer-reviewed article in Viruses supporting Brilacidin's COVID-19 treatment potential can be accessed at the link below.
Tytan Cybernetics
@NIHKEV
22m
Join us Saturday, October 23rd at 2:30pm PST for a Special Shareholder Meeting -- I'm going to introduce our new Director of Strategic Partnerships! She's a great asset to our team as we build our #EV #Crypto Empire!! Party popper High voltage sign $NIHK $DRNG $GMPW
We all think he should be done it differently, think of it this way , Ian likes to have money he can use in the future, hence the warrants , and he can get the funding now eventually Fuel positive will have profits and carbon credits also , so with the prototypes starting early 2022 we should see a very big interest in NHHHF. I am long also this sector is in the billions if not trillion sector.
NEWS -- FuelPositive Announces CAD$7 Million Private Placement with U.S. Institutional Investors
TORONTO, Oct. 22, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTCQB: NHHHF) is pleased to announce it has entered into a subscription agreement with certain U.S. institutional investors for gross proceeds of approximately CAD$7 million in a private placement in the United States, comprised of 30,434,784 common shares and warrants to purchase an aggregate of up to 30,434,784 common shares at a purchase price of CAD$0.23 per common share and associated warrant. The warrants have an exercise price of CAD$0.255 per common share and exercise period of three years. The net proceeds of the private placement will be used by the Company to increase the number of available FuelPositive carbon-free ammonia systems to deploy into high profile demonstration projects throughout 2022 and for general corporate purposes.
The private placement is expected to close on or about October 26, 2021, subject to satisfaction of customary closing conditions and approval of the TSX Venture Exchange.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement in the United States.
No securities were offered or sold to Canadian residents in connection with the private placement.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This news release shall not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.
About FuelPositive
FuelPositive is a Canadian growth-stage technology company committed to providing commercially viable and sustainable “cradle to cradle” clean energy solutions, including carbon-free ammonia (NH3), for use across a broad spectrum of industries and applications.
By focusing on technologies that are clean, economically advantageous/realizable and that leverage existing infrastructure, the Company aims to change the course of climate change through practical solutions that can be implemented now.
The Company’s core technology, a modular and scalable carbon-free NH3 system, takes air, water and sustainable electricity and synthesizes it into a non-polluting chemical for multiple applications, including fertilizer for farming, fuel for internal combustion engines and a solution for grid storage. It is being considered as a replacement for fossil fuels and as a key enabler of the hydrogen economy.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the intention to complete the private placement and the expected expenditures of the proceeds of the private placement, are forward-looking statements.
This forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://mailbox1@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- InvestorNewsBreaks – FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) Targeting Early 2022 Rollout of Carbon-Free NH3 Demonstration Programs
October 20, 2021
FuelPositive (TSX.V: NHHH) (OTCQB: NHHHF) is looking to change the energy landscape through its flagship project, which entails using its proprietary, first-of-its-kind technology to produce carbon-free ammonia (“NH3”). The company aims to change the narrative around the current carbon-intense and energy-intense Haber-Bosch process of industrially synthesizing NH3. A recent article quotes NHHHF CEO Ian Clifford as saying, “Our system is entirely carbon-free… We take sustainable electricity, water and air, and we produce carbon-free NH3, which can be utilized across multiple industries as an extremely versatile material… We are now just in the process of commercializing the technology, and we plan to have demonstration units ready and out there in the real world early in 2022.” The units, currently in the manufacturing stage, will enable FuelPositive to showcase real-world applications for the technology. “To this end, the company is focused on determining and putting in place the best, highest-profile demonstration programs possible early in 2022… FuelPositive will initially focus these demonstration programs on agriculture, as the sector already understands the importance of NH3 as a fertilizer.”
To view the full article, visit https://ibn.fm/32RA3
About FuelPositive Corporation
FuelPositive is a Canadian growth-stage technology company committed to providing commercially viable and sustainable “cradle to cradle” clean energy solutions, including carbon-free ammonia (“NH3”), for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, economically advantageous/realizable and that leverage existing infrastructure, the company aims to change the course of climate change through practical solutions that can be implemented now. The company’s core technology, carbon-free NH3, takes air, water and sustainable electricity and converts it to a non-polluting chemical for multiple applications, fertilizer for farming, fuel for internal combustion engines and a solution for grid storage. It is being considered as a replacement for fossil fuels and as a key enabler of the hydrogen economy. For more information, visit www.FuelPositive.com.
NOTE TO INVESTORS: The latest news and updates relating to NHHHF are available in the company’s newsroom at https://ibn.fm/NHHHF
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NEWS -- CytoSorbents Comments on REMOVE Study Presentation
MONMOUTH JUNCTION, N.J., Oct. 20, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using CytoSorb®1 blood purification, makes additional comments on the investigator-initiated REMOVE study following the formal presentation of trial results on Saturday, October 16th at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain.
This presentation adds to the information made publicly available by the preliminary data abstract at EACTS for the REMOVE ("Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis") investigator-initiated, randomized, controlled trial, and commented upon in a press release dated October 7, 2021. The presentation by REMOVE Study Director, Dr. med. Mahmoud Diab, from University Hospital Jena, Germany included additional patient demographic and adverse event data from the study. No study population subgroup analyses were reported. Dr. Diab commented on safety and concluded that there was "no signal for harm due to the use of CytoSorb® in patients undergoing surgery for infective endocarditis."
Professor Dr. med. Torsten Doenst, Head of the Cardiothoracic Surgery Department, University Hospital Jena, Germany, and coordinating center of the REMOVE study stated, "The REMOVE topline results presented at the EACTS meeting contribute significant and valuable information on the intraoperative use of CytoSorb in patients undergoing valve replacement surgery for infective endocarditis. Although the pre-specified primary outcome of the study was neutral, we demonstrated CytoSorb's ability to reduce cytokines. In addition, REMOVE also suggests that the use of CytoSorb in this setting is safe, with a similar adverse event profile to standard of care therapy. Even though our data suggest that the intraoperative use of CytoSorb in a general endocarditis patient population may not be helpful, it is also not harmful, and it is conceivable that specific patient types may benefit from the therapy's ability to lower cytokine levels. We plan to work collaboratively with CytoSorbents to perform additional exploratory analyses of the REMOVE data to better characterize and identify the best populations to be included in future studies. We are pleased with CytoSorbents' continued commitment to high quality evidence generation in cardiac surgery."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We want to congratulate the REMOVE investigators who executed this important trial. We are encouraged that the intraoperative use of CytoSorb during cardiothoracic surgery had a favorable adverse event profile in this large randomized, controlled trial and that it reduced cytokines, validating CytoSorb's mechanism of action. Taking all evidence into account, we continue to believe that CytoSorb treatment of select endocarditis patients with high acuity of illness may provide clinical benefits, such as improved hemodynamic stabilization, especially when use of the therapy is extended postoperatively. We look forward to our continued collaboration with Professor Doenst and his investigative team to better understand and analyze the results from the REMOVE trial to inform the design of future potential studies using CytoSorb in more specific infective endocarditis populations. Importantly, the accumulating evidence of promising safety with intraoperative CytoSorb use during cardiothoracic surgery, including both studies presented at the recent EACTS conference, bodes very well for our U.S. FDA-approved clinical programs in cardiac surgery investigating intraoperative use of CytoSorbents' technology in additional indications, specifically the REFRESH 2-AKI, STAR-T, and STAR-D pivotal studies."
1 CytoSorb is approved in the European Union. CAUTION: In the United States, CytoSorb is classified as an investigational device limited by United States law to investigational use.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 152,000 CytoSorb devices have been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, anticipated future results and performance, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-comments-on-remove-study-presentation-301404369.html
SOURCE CytoSorbents Corporation
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights
Conference call and webcast to take place on Friday, November 5, 2021, at 8:00 a.m. ET
SAN DIEGO and CALGARY, AB, Oct. 19, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Friday, November 5, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the third quarter of 2021.
Conference Call & Webcast
Date: Friday, November 5, 2021
Time: 8:00 a.m. Eastern Daylight Time
Dial In – North American Toll-Free: (888) 664-6383
Dial In – International: (416) 764-8650
Conference ID (if needed): 7285-9440
Webcast: https://produceredition.webcasts.com/starthere.jsp?ei=1503123&tp_key=d752d0402b
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 859-440#.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes, and benefits of its current or pending clinical trials involving pelareorep; our goals, objectives and strategies; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto:?/tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights-301403482.html
SOURCE Oncolytics Biotech Inc.
View original content: http://www.newswire.ca/en/releases/archive/October2021/19/c1903.html
NEWS -- Plus Therapeutics Announces FDA Clearance of Investigational New Drug Application for 186RNL for the Treatment of Leptomeningeal Metastases
Patient accrual for the Phase 1 dose escalation clinical trial of 186RNL (ReSPECT-LM) is expected in the fourth quarter of 2021
AUSTIN, Texas, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.
“LM is an increasingly common secondary cancer complication, occurring as a result of increasing observed survival rates for a variety of primary solid and hematologic tumors,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas and ReSPECT-LM Principal Investigator. “Given the excellent safety data thus far using 186RNL in recurrent glioblastoma, and the preclinical efficacy data when used in animal models of LM, we are optimistic about the potential safety and efficacy of 186RNL as a novel treatment option for LM.”
The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.
“Leptomeningeal metastasis is a neurologically devastating and fatal complication of cancer,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “Our latest approved IND application is part of a multifaceted plan to expand our radiotherapeutic pipeline with promising, innovative drugs to treat a variety of rare and difficult to treat cancers.”
The ReSPECT-LM Phase 1 clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.
About Plus Therapeutics, Inc.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “plan,” “can,” “design,” “intend,” “potential,” “expect,” “target,” “focus,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; the Company’s ability to expand clinical testing of 186RNL to additional sites and additional indications, such as leptomeningeal metastases and pediatric brain cancer; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; the Company’s IP strategy; competition; future development and/or expansion of its product candidates and therapies in its markets; its ability to obtain and maintain regulatory approvals including statements regarding the Company’s intent to submit any new IND application; expectations as to the Company’s future performance; the Company’s need for additional financing and the availability thereof; its ability to fully access its equity line with Lincoln Park; any changes to its interest expenses; the Company’s ability to continue as a going concern; operating results; and the potential enhancement of the Company’s cash position through development, marketing, and licensing arrangements.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Nano Mobile Announces “NFTsByGamers.com”
TORRANCE, CA, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Nano Mobile “the Company” (OTC: VNTH TWTR: @NanoTechCrypto), a gaming, crypto and NFT engagement company, is pleased to announce the start of “NFTsByGamers.com”: an exchange platform of NFTs by gamers for gamers.
“We’re proud to announce the start of the development of our NFTsByGamers.com platform. We’re planning to rapidly create a marketplace for the creation and exchange of NFTs amongst the gaming community. “NFTsByGamers.com” will be the NFT forum by gamers for gamers.” CEO David Kittle
For more information, please view the company Twitter @NanoTechCrypto
About Nano Mobile
Founded by Gamers for Gamers, Nano Mobile develops innovative ideas, and seeks to develop technologies and products in the Gaming, Crypto and NFT industries. Actively searching Dynamic Partnerships and Mergers to enhance rapid growth of the Company.
About CEO David Kittle
Passionate about implementing and advancing technology in society, David Kittle grew up immersed in the gaming and crypto playgrounds of the 21st century. “I've always been fascinated in the ways in which Gaming bonds people from all over the globe. Crypto and NFTs are a natural extension of these vivacious communities and I'm excited to be in the midst of expanding the further development of these economies.”
Notice Regarding Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words “believes,” “expects,” “anticipate” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
Contact
David Kittle
9663 Santa Monica Blvd #366
Beverly Hills, CA 90212
(877) NANOMT1
mailto://Contact@NanoMobileTech.com
NEWS -- Vivos Inc Signs a MOU for a New Regional Clinic in NY for IsoPet Therapy
Richland WA, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that it signed a Memorandum of Understanding with the Animal Hospital Surgical Center in East Meadow New York on Long Island to become an IsoPet regional therapy center. Vivos Inc is currently working on obtaining the radioactive material handling license and on completing their certification training. They will be specializing in treating the margin of cancerous tumors after they have been surgically removed. This is expected to provide additional life extension. This application was recommended by our Veterinary Medicine Advisory Board.
Dr. Mike Korenko stated, “After licensing and certification, this will be our first east coast regional center and it is near a major population center. Initially it will be specializing in treating the margins of resected tumors, but they will have the capability to treat other solid tumors. As thought leaders and experienced surgeons Dr. Tomas Infernuso and Dr. Joe Impellizeri are also interested in applying their non-intrusive surgical techniques to treat a range of internal tumors within the pets, such a brain and bladder cancers. We expect to learn from their experience and transfer that knowledge to other clinics.”
Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (Isopet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
Radiogel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
Radiogel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The Isopet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that Isopet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval was required for treating skin cancer, which is the largest market sector. Following the demonstration phase, Vivos is able to generate revenue through the sale of Isopet® to University animal hospitals and private veterinary clinics.
Isopet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
NEWS -- Lineage to Be Featured in B. Riley Securities Fall 2021 “Growth Biotech Best Ideas” Virtual Series on October 18, 2021
Fireside Chat with B. Riley Research Scheduled for 12:30pm Eastern
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Lineage will be featured in the B. Riley Securities Fall 2021 “Growth Biotech Best Idea” Virtual Series, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities. The fireside chat will feature Lineage management, including, Brian M. Culley, Chief Executive Officer, Kevin Cook, Chief Financial Officer, and Gary Hogge, Senior Vice President of Clinical and Medical Affairs. The Lineage team will be joined by Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision. Interested investors can register to join the live event today at 9:30am Pacific / 12:30pm Eastern here.
Therapeutic Area Expert
Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.
Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the Massachusetts Eye and Ear Infirmary at Harvard University, and at Hospital San José, Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.
Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211018005115/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
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NEWS -- Nano Mobile Moves into Gaming/Crypto with New CEO David Noah Kittle
TORRANCE, CA, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Nano Mobile Healthcare Inc. “the Company” (OTC: VNTH TWTR: @NanoTechCrypto), a gaming, crypto and NFT engagement company, presents David Noah Kittle as Chief Executive Officer of Nano Mobile Tech.
“I’m honored and excited to come on board with Nano Mobile to help steer the company towards technological innovation. I’ve numerous ideas I’m seeking to develop for both Mergers and Acquisitions with products in the gaming and Crypto universe. I’m planning to use our 7 figure capital investment to aggressively grow the Company.” CEO David Kittle
For more information, please view the company Twitter @NanoTechCrypto
About Nano Mobile
Founded by Gamers for Gamers, Nano Mobile develops innovative ideas, technologies and products in the Gaming, Crypto and NFT industries. Actively searching Dynamic Partnerships and Mergers to enhance rapid growth of the Company.
About CEO David Kittle
Passionate about implementing and advancing technology in society, David Kittle grew up immersed in the cybernetic playgrounds of the 21st century. “I've always been fascinated in the ways in which Gaming bonds people from all over the globe. Crypto and NFTs are a natural extension of these vivacious communities and I'm excited to be in the midst of expanding the further development of these economies.”
Notice Regarding Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words “believes,” “expects,” “anticipate” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
Contact
David Kittle
9663 Santa Monica Blvd #366
Beverly Hills, CA 90212
(877) NANOMT1
mailto://Contact@NanoMobileTech.com
I like EVCOIN !
NEWS -- Navidea Biopharmaceuticals Appoints Thomas Forest Farb-Horch and Agnieszka Winkler to the Board of Directors
DUBLIN, Ohio, October 14, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Thomas Forest Farb-Horch and Agnieszka Winkler to its Board of Directors, effective October 7, 2021, each with a three-year term ending concurrently with the Company’s 2024 annual stockholders’ meeting.
Thomas Forest Farb-Horch has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally. Mr. Farb has served as the Chief Executive Officer, President, co-founder and director of Thrive Bioscience, Inc. since May 2014. He has also served as President, Chief Operating Officer and in other C-level positions at several other companies, including Interneuron Pharmaceuticals (NASDAQ), Indevus Pharmaceuticals (NASDAQ), and Cytyc (NASDAQ). Mr. Farb currently serves on the boards of directors of North Shore InnoVentures and AutoImmunity Biologic Solutions, and is a member of the scientific advisory board of Emervax. Mr. Farb previously served on the boards of directors of Fair Isaac (NYSE:FICO), Redwood Trust (NYSE:RWT), HNC Software (NASDAQ), Retek Systems (NASDAQ) and Symon Communications (NASDAQ). Mr. Farb earned a B.A. in sociology from Harvard University.
Agnieszka Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies. Ms. Winkler currently serves on the board of directors of Virco (NASDAQ:VIRC) and the board of trustees of each of Santa Clara University and the African Diaspora Network. She also serves as Chair of the board of directors of the Jesuit School of Theology and as President of the board of Catholic Charities of Santa Clara County. Ms. Winkler has previously served on numerous public company boards such as SuperCuts (NASDAQ), Reno Air (NASDAQ), The Cheesecake Factory (NASDAQ:CAKE), and Inter-Tel (NASDAQ), as well as private company boards including Ascension, a $22B healthcare system, Ascension Network and IPLocks. She was the founder and former Chair and Chief Executive Officer of TeamToolz, a software company, and Winkler Advertising, both of which were acquired. Ms. Winkler earned a B.A. in history from Holy Names University, an M.A. in history from San Jose State University, and an M.B.A. from Santa Clara University.
Navidea Chief Executive Officer Jed Latkin said, "Navidea is pleased to add two highly respected and exceptionally talented individuals to its Board of Directors. Their combined experience will help guide the Company through its next phases of growth and development."
Navidea Chair of the Board Alexander L. Cappello said, "I am proud to join Jed Latkin in welcoming seasoned directors of such high caliber as Thomas Farb and Agnieszka Winkler to the Navidea Board of Directors. Their combined management experience as CEOs, operators, public company managers, all aspects of leadership and every possible committee brings a wealth of maturity, relationships and experience to Navidea."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211014005277/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Oncolytics Biotech®Partner Adlai Nortye Doses First Patient in Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer
NEWS -- Plus Therapeutics to Announce Third Quarter 2021 Financial Results and Host Conference Call on October 21, 2021
AUSTIN, Texas, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, announced that the Company will report third quarter 2021 financial results on Thursday, October 21, 2021, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events
Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.
Conference dial-in: 877-876-9173
International dial-in: 785-424-1667
Conference ID: PSTVQ321
Conference Call Name: Plus Therapeutics Third Quarter 2021 Results Conference Call
Following the live call, a replay will be available on the Company’s website under the 'Investor Relations' section (https://ir.plustherapeutics.com/overview/default.aspx). The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to formulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb-ATR™ Antithrombotic Removal System for intraoperative removal of ticagrelor during cardiothoracic surgery. The STAR-T trial received full FDA IDE Approval in July 2021, and is being performed under the auspices of FDA Breakthrough Designation granted in April 2020. The STAR-T trial is expected to enroll up to 120 patients across 20 sites and be completed by 2022. The first patient was enrolled by Dr. Bradley S. Taylor, Chief of the Division of Cardiac Surgery and Director of Coronary Revascularization and site Principal Investigator at the University of Maryland Medical Center.
First Patient Enrolled in U.S. STAR-T Trial Evaluating DrugSorb-ATR™ to Remove Ticagrelor During Cardiothoracic Surgery
Dr. Bradley S. Taylor stated, "Ticagrelor is an antiplatelet agent routinely used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction, and stroke. However, when urgent surgery is required, patients on ticagrelor are at very high risk of serious and potentially fatal bleeding. We are very pleased to enroll the first patient in the landmark STAR-T study that is investigating the ability of DrugSorb-ATR™ to remove ticagrelor during surgery and reduce the risk of bleeding in these patients. If positive, STAR-T could establish DrugSorb-ATR as an easily implemented solution that addresses a long-standing, frequent, and critical unmet medical need faced by cardiac surgery centers around the world."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "Removing antithrombotic agents intraoperatively with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and provide substantial cost savings to heart centers around the world. The FDA approved STAR-T trial has now left the station and we will work diligently to deliver on our stated goal to finish the trial in 2022. Following the granting of a second Breakthrough Designation for the removal of apixaban and rivaroxaban, we recently received full FDA approval of our IDE application to conduct the Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) trial, a second, very similar study that will leverage the existing infrastructure of STAR-T. We anticipate fast study start-up and estimate that the first patient will be enrolled early in 2022. The goal of both studies is to gain FDA marketing approval for the most widely prescribed next generation antiplatelet and anticoagulant agents and unlock an estimated $1 billion U.S. market opportunity."
In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need. Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent heart attack, stroke, or cardiovascular death. Ticagrelor is frequently preferred as first-line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement. However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery. As several clinical studies, such as the PLATO trial, have shown, these patients face a very high risk of severe or life-threatening perioperative bleeding. CytoSorbents' CytoSorb® therapy is the only treatment approved to remove ticagrelor during cardiopulmonary bypass in the E.U. The DrugSorb-ATR™ Antithrombotic Removal system is based on the same polymer technology as CytoSorb®. If FDA marketing approval is obtained by the FDA, DrugSorb-ATR™ would be marketed in the United States for ticagrelor removal during urgent cardiothoracic surgery, with the intention of reducing the risk of bleeding.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 152,000 CytoSorb devices have been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, anticipated future results and performance, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
Tytan Cybernetics
@NIHKEV·
40m
Building value is one of my biggest commitments as CEO; it's exciting researching ways to expand new technologies for electric vehicles that both enhance the driver experience and bring value.
NEWS -- NanoViricides, Inc. Has Filed its Annual Report: Coronavirus Drug Program Rapidly Moving Towards Clinical Stage
SHELTON, CT / ACCESSWIRE / October 13, 2021 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2021 with the Securities and Exchange Commission (SEC) on Tuesday, October 12, 2021. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/0001379006/000110465921125343/tm2124471d1_10k.htm).
We reported that, as of June 30, 2021, we had cash and cash equivalent current assets balance of approximately $20.8 Million. In addition, we reported $9.08 Million in Property and Equipment (P&E) assets. The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were less than $0.4 Million. In comparison, as of June 30, 2020, we had cash and cash equivalent balance of approximately $14 Million, P&E assets of approximately $9.54 Million, and total current liabilities of approximately $2.15 Million.
During the fiscal year ended June 30, 2021. we raised approximately $10.4 Million in net proceeds from an underwritten equity offering with Kingswood Capital Markets, a Division of Benchmark Investments, Inc. ("Kingswood", now known as EF Hutton) on July 10, 2020. No warrants were issued in this Offering. Additionally, on March 2, 2021 we raised approximately $6.1 million in net proceeds from the sale of common stock under an At Market Issuance Sales Agreement with B. Riley Securities, Inc. that was entered into on July 31, 2020. These additional funds have significantly bolstered the Company's finances, enabling it to advance its COVID-19 drug candidates towards human clinical trials.
We estimate that we have sufficient funds to complete initial human clinical trials for at least one of our drug candidates.
We have made significant progress in responding to the global COVID-19 pandemic. As early as May/June 2020, we had already developed potential drug candidates. Our COVID-19 drug candidates successfully entered core safety pharmacology studies required prior to commissioning human clinical trials around October/November, 2020. These studies have now been completed and we have received the GLP Safety/Toxicology reports from the external CRO in August 2021. We are now engaged in the preparation of clinical trial protocols and other activities that would be necessary for filing of an IND with the US FDA or equivalent regulatory filings for entering into human clinical trials in other countries.
In the reported year and subsequently to date, we have already completed pre-clinical IND-enabling studies on our novel SARS-CoV-2 drug candidate NV-CoV-2. In addition to NV-CoV-2 itself as a drug to combat COVID-19, we are also developing another SARS-CoV-2 drug candidate, NV-CoV-2-R, which encapsulates remdesivir inside NV-CoV-2. While remdesivir substantially blocks the replication of the virus inside cells, NV-CoV-2 is designed to block the virus outside cells by entrapping it and thereby not allowing it to infect the cells in the first place. Thus, NV-CoV-2-R is designed to block both the intra-cellular life cycle of the virus and the extra-cellular life cycle of the virus. Blocking both lifecycles should enable complete control of the viral disease, promising a potential cure. Remdesivir, sponsored by Gilead, is a known antiviral drug that has received full US FDA approved for treatment of COVID-19 and has received EUA in many countries. We are developing NV-CoV-2-R on our own, independently of Gilead.
We intend to develop NV-CoV-2 through Phase1/2a clinical trials first, and anticipate clinical development of NV-CoV-2-R thereafter.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective against a totally lethal coronavirus lung infection in an animal model study in rats based on multiple indicators. Treatment with the standard remdesivir formulation extended lifespan by only 2 days, while treatment with NV-CoV-2 and NV-CoV-2-R extended the lifespan by 8.5 and 10.5 days respectively; an extremely significant improvement attesting to a very strong effectiveness of our drug candidates.
NV-CoV-2 was found to be effective in cell cultures against infection by several unrelated coronaviruses, including SARS-CoV-2 pseudovirions (see the Company's press release dated October 11, 2021 for details). These studies have established that both NV-CoV-2 and NV-CoV-2-R are broad-spectrum, pan-coronavirus drugs and therefore would remain effective even as variants emerge.
We have successfully developed oral syrup formulations that can be administered easily to anyone including children. Orally administered NV-CoV-2 and NV-CoV-2-R were found to be highly effective in the animal model of coronavirus lethal lung infection caused by h-CoV-NL63 that emulates the lung pathology of SARS-CoV-2 infection.
Oral administration is being presented as the success story of molnupiravir (Merck/Ridgeback). However, an earlier clinical trial of oral molnupitavir in moderate to severe disease was terminated due to lack of efficacy by Merck. It is currently being promoted as a "game-changer" treatment for mild infection despite its marginal effectiveness. This simply attests to the pressing need for oral drugs to combat mild, moderate, and severe COVID-19.
Our drugs NV-CoV-2 and NV-CoV-2-R have both exceeded, in animal studies, the effectiveness of remdesivir, which is approved for treatment of severe hospitalized cases of COVID-19, and has shown substantial clinical benefit in clinical trials in moderate to severe COVID-19 patients. If the strong effectiveness of NV-CoV-2 and NV-CoV-2-R observed in animal studies is borne out in human clinical trials, then our drugs would be substantially more effective than existing therapies. We are developing NV-CoV-2 and NV-CoV-2-R for administration by (a) Injection or Infusion in hospitalized patients, (b) direct lung Inhalation for patients with severe lung disease, as well as (c) oral route for the benefit of pediatric patients as well as non-hospitalized patients.
Previously, the Company has completed pre-clinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-101. The Company intends to re-engage this program with filing an IND and performing clinical trials for NV-HHV-101 regulatory approvals after our COVID-19 program.
The nanoviricide platform technology is a leading nanomedicine technology that uniquely enables attack on both (a) the virus particles outside cells and (b) the replication of virus inside cells. If both of these factors can be controlled effectively, then the resulting drug could be a cure for the viral disease. In contrast, antibodies only bind to the virus particles outside cells, and tag them for the immune system for further processing, whereas antiviral small chemical drugs affect only the replication cycle of the virus inside cells.
Research and development expenses for the year ended June 30, 2021 were approximately $6.11 Million, compared to about $4.69 Million in the prior year ending June 30, 2020. The increase was primarily due to increased costs of pre-clinical R&D on the COVID-19 drug candidates. General and administrative expenses (G&A) were at about $2.6 Million, compared to $3.3 Million in the prior year. The reduction in G&A is primarily due to decrease in legal, professional, and consulting costs.
For the year ended June 30, 2021, the Company had a net loss of about $8.82 million, or a basic loss per share of $0.81 compared to a net loss of $13.45 Million, or a basic loss per share of $2.39 for the year ended June 30, 2020.
During the fiscal year, we further strengthened our Audit Committee and our Board of Directors with the addition of Mr. Brian Zucker, CPA, effective November, 2020. Mr. Zucker has over thirty years of experience as a CPA specializing in the securities industry. He brings valuable multi-faceted experience with public companies, as well as financings and banking institutions to our Board.
The Company's drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. The Company has a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of a number of human viral diseases including VZV (shingles), HSV-1 and HSV-2. Additionally, the Company and TheraCour have signed a Memorandum of Understanding for the field of human coronavirus infections, which has provided a limited development license to the Company at no additional cost. A definitive agreement is currently being negotiated between the parties.
The Company intends to perform the regulatory filings and own all the regulatory licenses for the drug candidates it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. We believe that our drug candidates would be difficult for a virus to escape because these binding sites for a given virus do not change despite mutations and other changes in the virus. Further, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
The nanoviricide platform is designed to additionally hold small molecule active pharmaceutical ingredients (API's) of different types in its "belly". This allows targeted delivery of the encapsulated API to infected cells, and is also expected to improve the pharmacokinetic and pharmacodynamic properties of the API, such as rapid metabolism. Rapid metabolism is known to be an effectiveness-limiting factor for many drugs, including remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been approved under emergency use regulations in the USA as well as in many other countries.
About NanoViricides
NanoViricides, Inc. (the "Company") (http://www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: human Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.
Contact:
NanoViricides, Inc.
mailto://info@nanoviricides.com
https://www.nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
mailto://clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View source version on accesswire.com:
https://www.accesswire.com/667865/NanoViricides-Inc-Has-Filed-its-Annual-Report-Coronavirus-Drug-Program-Rapidly-Moving-Towards-Clinical-Stage
Tytan Cybernetics
@NIHKEV
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