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Also, if I click the last trade price for one of those AMEX stocks to view the transactions, I see the Ask and Bid prices listed there. What?
On the Ihub Streamer, all the stocks show values for Ask and Bid -- except for those on the AMEX exchange. Why is that? Thanks.
NEWS -- Nano Mobile Healthcare, Inc Announces Closing of Change of Control Transaction and Provided Shareholders’ Update
LOS ANGELES, CA, Sept. 23, 2022 (GLOBE NEWSWIRE) -- Nano Mobile Healthcare, Inc. “the Company” (OTC: VNTH) is pleased to announce that the closing of the change of control deal announced on September 16, 2022, closed yesterday September 22, 2022.
Dear Fellow Shareholders,
I would like to take this opportunity to introduce myself and the future of Nano Mobile Healthcare, Inc. (VNTH) in the Electric Charging space. I have been a private investor for a decade in every sector and exchange. After living in California for six years and witnessing the hasty transition into Electric Vehicles, I wanted to be a part of it. The efficient cost of installing and owning charging stations will make our business plan move swiftly with such high demand..
Our business plan was primed before taking over VNTH for Electric Charging stations. We intend on targeting properties to build out charge stations for fast-charge while running errands or shopping. We plan to work with property managers, business owners, California Government, for their charging needs. Level-1 chargers will be implemented across unusual properties; level-2 chargers will be cited at points of convenience for EV consumers; level-3 chargers for the quick full charge when the driver can be stretching and grabbing a snack at a rest stop. The company will reveal the particular property groups and specific partner names, website, and our first acquisition in the coming weeks.
NO REVERSE SPLIT:
The Company has a no-reverse-split clause for two years.
Even after the expiry of the two years clause, I would also like to assure shareholders that the company does NOT see a reverse split in its future.
NO TOXIC NOTES:
The Company has a no-toxic-notes clause for two years.
Like the RS clause, the Company has resolved to NOT entertain any toxic notes in the future, even after the two years clause has expired.
EV RELATED BUSINESS / EV CHARGE STATIONS:
The EV space is growing at a rapid rate. We are already discussing with fully operating charging stations and businesses to acquire them entirely. Acquiring, installing, renting, and many more possibilities are being evaluated. We will also be dissecting the information from California's blueprint budget for electric vehicle initiatives.
Being an investor in the markets myself, I believe in regular updates, as shareholder communication will be a priority.
I am very excited to be sharing this journey with everyone. Electric Charging is becoming a part of everyday life and soon Nano Mobile will help normalize it nationwide.
Thank you for your continued support!
CEO Adam Matruski.
@OfficialVNTH
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
CEO Adam Matruski.
9663 Santa Monica Blvd #366
Beverly Hills, CA 90212
(877) NANOMT1
@OfficialVNTH
mailto://Contact@NanoMobileTech.com
NEWS -- Plus Therapeutics Executes $17.6 Million Award Contract with Cancer Prevention & Research Institute of Texas
NEWS -- Provectus Biopharmaceuticals Announces Exclusive License Option Agreement with Ophthalmic Biophysics Center of Bascom Palmer Eye Institute at University of Miami for Treatment of Eye Infections
KNOXVILLE, TN, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has entered into an option agreement with the University of Miami (UM) for an exclusive worldwide license of intellectual property developed by the Ophthalmic Biophysics Center (OBC) of Bascom Palmer Eye Institute (BPEI), which is part of the UM Health System, for the use of OBC’s photodynamic antimicrobial therapy (PDAT) medical device in combination with Provectus’ proprietary pharmaceutical-grade rose bengal for the treatment of bacterial, fungal, and viral infections of the eye. The Company also initiated a sponsored research program with OBC to investigate Provectus’ rose bengal for the treatment of infectious keratitis.
Established in 1970 by BPEI founding director Edward W.D. Norton, MD and Jean-Marie Parel, IngETS-G, PhD, FARVO, OBC performs translational eye care research in all areas of ophthalmology, from the retina and vitreous to the cornea, glaucoma, cataracts, neuro-ophthalmology, and ocular oncology. OBC has developed more than 350 surgical instruments and clinical devices to date.
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors said, “Provectus is pleased to advance its collaboration with OBC director Dr. Parel, Dr. Guillermo Amescua, MD, a board-certified ophthalmologist and director of Bascom Palmer’s Ocular Surface Center, and the entire OBC team to now include this important option-to-license step. OBC’s innovative and comprehensive work on rose bengal PDAT has, among other things, shown in vitro activity against multiple etiologies of microbial keratitis1,2,3,4,5, including drug-resistant strains3,6, established in vivo safety7, demonstrated in vitro superiority over riboflavin PDAT8,9, and achieved clinical proof-of-concept for the treatment of infectious keratitis10,11.”
Mr. Rodrigues added, “OBC’s clinical work in ophthalmology, Provectus’ clinical trials in oncology and dermatology, and the Company’s wide-ranging preclinical work in hematology, infectious diseases, animal health, tissue regeneration and repair, and other disease areas support a key component of Provectus’ business strategy, which is to demonstrate the broad spectrum therapeutic platform potential of the Company’s proprietary pharmaceutical-grade halogenated xanthene small molecule rose bengal.”
About Bascom Palmer Eye Institute
BPEI serves as the Department of Ophthalmology for the UM Miller School of Medicine in Miami, Florida. Its mission is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2022-2023, U.S. News & World Report (U.S. News) ranked BPEI as the nation’s best in ophthalmology, marking the 21st time and 19th consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual “Best Hospitals” rankings 33 years ago.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is rose bengal sodium. A second HX molecule has been synthesized.
Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, infectious diseases, ophthalmology (clinical-stage), animal health, and tissue regeneration and repair, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at https://www.provectusbio.com.
References
1. Arboleda A, Miller D, Cabot F, et al. Assessment of rose bengal versus riboflavin photodynamic therapy for inhibition of fungal keratitis isolates. Am J Ophthalmol. 2014;158:64–70.
2. Durkee H, Arboleda A, Aguilar MC, et al. Rose bengal photodynamic antimicrobial therapy to inhibit Pseudomonas aeruginosa keratitis isolates. Lasers Med Sci. 2019;35:861–866.
3. Halili F, Arboleda A, Durkee H, et al. Rose bengaland riboflavin-mediated photodynamic therapy to inhibit methicillin-resistant Staphylococcus aureus keratitis isolates. Am J Ophthalmol. 2016;166:194–202.
4. Schrier A, Greebel G, Attia H, Trokel S, Smith EF. In vitro antimicrobial efficacy of riboflavin and ultraviolet light on Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, and Pseudomonas aeruginosa. J Refract Surg. 2009;25:S799–S802.
5. Naranjo A, Pelaez D, Arrieta E, et al. Cellular and molecular assessment of rose bengal photodynamic antimicrobial therapy on keratocytes, corneal endothelium and limbal stem cell niche. Exp Eye Res. 2019;188:107808.
6. Amescua G, Arboleda A, Nikpoor N, et al. Rose rengal photodynamic antimicrobial therapy: a novel treatment for resistant Fusarium keratitis. Cornea. 2017;36:1141–1144.
7. Martinez JD, Arrieta E, Naranjo A, Monsalve P, Mintz KJ, Peterson J, Arboleda A, Durkee H, Aguilar MC, Pelaez D, Dubovy SR, Miller D, Leblanc R, Amescua G, Parel JM. Rose Bengal Photodynamic Antimicrobial Therapy: A Pilot Safety Study. Cornea. 2021 Aug 1;40(8):1036-1043.
8. Arboleda A, Miller D, Cabot F, Taneja M, Aguilar MC, Alawa K, Amescua G, Yoo SH, Parel JM. Assessment of rose bengal versus riboflavin photodynamic therapy for inhibition of fungal keratitis isolates. Am J Ophthalmol. 2014 Jul;158(1):64-70.e2.
9. Adre E, Durkee H, Arboleda A, Alawa K, Maestre J, Mintz KJ, Leblanc RM, Amescua G, Parel JM, Miller D. Rose Bengal and Riboflavin Mediated Photodynamic Antimicrobial Therapy Against Selected South Florida Nocardia Keratitis Isolates. Transl Vis Sci Technol. 2022 Jan 3;11(1):29.
10. Naranjo A, Arboleda A, Martinez JD, Durkee H, Aguilar MC, Relhan N, Nikpoor N, Galor A, Dubovy SR, Leblanc R, Flynn HW Jr, Miller D, Parel JM, Amescua G. Rose Bengal Photodynamic Antimicrobial Therapy for Patients With Progressive Infectious Keratitis: A Pilot Clinical Study. Am J Ophthalmol. 2019 Dec;208:387-396.
11. Sepulveda-Beltran PA, Levine H, Altamirano DS, Martinez JD, Durkee H, Mintz K, Leblanc R, Tóthová JD, Miller D, Parel JM, Amescua G. Rose Bengal Photodynamic Antimicrobial Therapy: A Review of the Intermediate-Term Clinical and Surgical Outcomes. Am J Ophthalmol. 2022 Aug 8;243:125-134.
FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in Item 1A of:
the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and
Provectus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.
###
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Navidea Biopharmaceuticals Announces Presentation of Results from its Two Phase 2B Clinical Trials in Rheumatoid Arthritis at Upcoming American College of Rheumatology Annual Meeting
DUBLIN, Ohio, September 15, 2022--(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 that the results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the preliminary results of its ongoing NAV3-32 Phase 2B study have been accepted for presentation as posters at the Annual Meeting of the American College of Rheumatology ("ACR"), to be held November 10-14, 2022 in Philadelphia, PA (virtual and in person) ("ACR Convergence 2022").
In the completed NAV3-31 Phase 2B study (NCT03938636) titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" (Abstract #1977), 30 rheumatoid arthritis ("RA") patients with active RA set to start anti-tumor necrosis factor alpha ("TNFa") therapy were enrolled and followed for 24 weeks. Tc99m tilmanocept ("TIL") imaging performed at baseline and week 5 following therapy initiation had high overall accuracy at predicting American College of Rheumatology 50 ("ACR50") clinical response at 12 and 24 weeks (27/30 and 24/28 subjects, respectively) after therapy start. TIL imaging demonstrated high specificity (0.96 at weeks 12 and 24), positive predictive value (0.75 and 0.67, respectively), and negative predictive value (0.92 and 0.88, respectively), and the combination of TIL imaging data with serological and clinical markers in a multivariate model gave an area under the curve of 0.95 for prediction of response at week 24. These results indicate that marked changes in TIL uptake by week 5 presage clinical efficacy evaluations at week 12 and week 24 of treatment and demonstrate that TIL imaging can provide quantifiable imaging assessment of RA-involved joints that enables an objective, early prediction of clinical response.
In the ongoing NAV3-32 Phase 2B study (NCT04078191) titled, "A Comparison of Tc99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)" (Abstract #1979), the primary objective is to assess the relationship between joint-specific TIL uptake and the pathobiology of RA-involved joint tissue. Preliminary results on the first eleven patients indicates that quantitative TIL uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in an individual RA patient’s joint inflammation. The cellular composition of RA-inflamed joints is known to vary between patients and is frequently separated into one of three pathotypes: fibroid, diffuse myeloid, and lympho-myeloid. Knowledge of an individual RA patient’s pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. Imaging with TIL, a high affinity ligand to CD206 expressed on activated macrophages, offers the potential to distinguish between pathotypes without need of invasive biopsy. In these preliminary results, TIL uptake in RA-inflamed joints was able to discretely differentiate patients with the fibroid pathotype (i.e., low macrophage involvement) from those having either the diffuse myeloid or lympho-myeloid pathotypes of RA (i.e., higher macrophage involvement). This could have significant implications for decision making onto which therapy a patient is placed.
Overall, data from these two studies supports the hypothesis that TIL imaging has the potential to provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working or likely to work. This could bring significant benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is currently possible.
Abstracts and presentation session information can be found on the ACR Annual Meeting website at:
https://acrabstracts.org/abstract/tc99m-tilmanocept-imaging-predicts-clinical-response-in-rheumatoid-arthritis-patients-beginning-new-anti-tnf%ce%b1-therapy/
and
https://acrabstracts.org/abstract/tc99m-tilmanocept-imaging-can-differentiate-the-fibroid-pathotype-of-rheumatoid-arthritis-from-non-fibroid-pathotypes-in-patients/
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these results with our collaborators at this internationally recognized meeting." Dr. Rosol continued, "As we continue to enroll both in the NAV3-32 TIL imaging-to-biopsy study as well as the NAV3-33 Phase 3 study in RA, this is the type of external validation of our work that reflects the recognized medical need for a robust, objective, noninvasive means of predicting clinical response to anti-TNFa therapies."
RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.
Reference
1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
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 http://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/20220915005677/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Vivos Inc Files a New Patent on the Hydrogel Component of IsoPet®/RadioGel™
Richland WA, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that they filed a patent application on their hydrogel component of IsoPet/RadioGel in the USA (16309: 17/943,311) and internationally (16389: PCT/US22/43274) under The Patent Cooperation Treaty (PCT).
Over the last eighteen months our team has worked with polymer contracting experts to optimize our hydrogel component. Our objectives were to maximize production output, to refine our specifications to yield the optimum gelation and resorption characteristics, to demonstrate reproducibility and to ensure that any residual solvents were minor and well below the FDA specifications limits for human therapy. As part of our improved Quality Management System, we are confident that the new Vivos Inc Standard Operating Procedure for Polymer Production will meet GMP/FDA Specifications.
Dr. Mike Korenko stated, “This was a substantial effort that revealed novel production insights that are not obvious and therefore patentable. As part of this process, we just filed a patent application on the hydrogel component, while keeping the production refinements as important proprietary intellectual property.
“This filing was on the heels of another milestone for Vivos, as the US Patent office recently gave us the Notice of Allowance for our patent to produce our yttrium phosphate microparticles, US Patent Application Serial No: 16-459,466. Our new particle patent and our hydrogel component patent filing are significant achievements consistent with our objective for strong intellectual property protection on both of our key components. We will continue to improve our processes to enhance our intellectual property as a fundamental business strategy as we continue our progress in establishing Radiogel™ and Isopet® as a next generation treatment option using Injectable Precision Radionuclide Therapy.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable Precision Radionuclide Therapy 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 microparticles 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 used 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 -- Tokens.com Shares Positive Outlook on Ethereum Merge
TORONTO, September 14, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, shares its positive outlook on the upcoming Ethereum Merge and the impact to its staking business segment.
Ethereum, the most widely used blockchain for NFTs and Web3 metaverses, will be making a significant processing upgrade on or about September 15th. The upgrade, called the ‘Merge’, marks the transition from a proof-of-work mechanism, performed by crypto miners, to a proof-of-stake mechanism, performed by crypto stakers.
The upgrade will require 99.9% less energy consumption to validate transactions than the previous mining process. As a result, the Ethereum blockchain will no longer require miners, who will be fully replaced by stakers, like Tokens.com. The upgrade will also allow Ethereum to achieve greater scale, with faster transaction speeds and lower transaction fees. Ethereum’s native token, ETH, is the second largest cryptocurrency after Bitcoin with a market capitalization of approximately $200 billion.
Tokens.com has been staking ETH at scale since early 2021 and owns over 3,100 ETH. Tokens.com anticipates no impact to its operations through the completion of the Merge other than increased revenues. Subsequent to the Merge, it is expected that the compensation for staking ETH will increase from current levels.
"We have been early adopters of the shift to staking and are one of the first public companies to own and stake ETH at scale," said Andrew Kiguel, CEO of Tokens.com. "Long-term mass adoption of Web3 and crypto requires a move to environmentally friendly processes. As a result, we have continued staking Ethereum, Solana, Polkadot and other layer one blockchains used in the creation of NFTs, metaverses and play-to-earn video games."
Tokens.com is committed to only investing in tokens compatible with a staking platform due to its increased energy efficiency and environmental friendliness. In addition to its ETH token ownership, Tokens.com owns Polkadot and Solana used for its staking business, amongst other tokens.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and builds Web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within Web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220914005179/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Shares Positive Outlook on Ethereum Merge
TORONTO, September 14, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, shares its positive outlook on the upcoming Ethereum Merge and the impact to its staking business segment.
Ethereum, the most widely used blockchain for NFTs and Web3 metaverses, will be making a significant processing upgrade on or about September 15th. The upgrade, called the ‘Merge’, marks the transition from a proof-of-work mechanism, performed by crypto miners, to a proof-of-stake mechanism, performed by crypto stakers.
The upgrade will require 99.9% less energy consumption to validate transactions than the previous mining process. As a result, the Ethereum blockchain will no longer require miners, who will be fully replaced by stakers, like Tokens.com. The upgrade will also allow Ethereum to achieve greater scale, with faster transaction speeds and lower transaction fees. Ethereum’s native token, ETH, is the second largest cryptocurrency after Bitcoin with a market capitalization of approximately $200 billion.
Tokens.com has been staking ETH at scale since early 2021 and owns over 3,100 ETH. Tokens.com anticipates no impact to its operations through the completion of the Merge other than increased revenues. Subsequent to the Merge, it is expected that the compensation for staking ETH will increase from current levels.
"We have been early adopters of the shift to staking and are one of the first public companies to own and stake ETH at scale," said Andrew Kiguel, CEO of Tokens.com. "Long-term mass adoption of Web3 and crypto requires a move to environmentally friendly processes. As a result, we have continued staking Ethereum, Solana, Polkadot and other layer one blockchains used in the creation of NFTs, metaverses and play-to-earn video games."
Tokens.com is committed to only investing in tokens compatible with a staking platform due to its increased energy efficiency and environmental friendliness. In addition to its ETH token ownership, Tokens.com owns Polkadot and Solana used for its staking business, amongst other tokens.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and builds Web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within Web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220914005179/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Innovation Pharmaceuticals' Investment in BT BeaMedical Helping Advance New Surgical Laser Platform
WAKEFIELD, MA / ACCESSWIRE / September 13, 2022 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today updated shareholders on recent progress by BT BeaMedical Technologies Ltd. ("BeaMed") (formerly known as Squalus Medical Ltd.) to advance its new image guided surgical laser platform for treating previously inoperable cases of epilepsy and for enabling new treatment options for cancer cases in multiple specialties. In June 2022, the Company announced acquiring an interest in BeaMed.
BeaMed has informed the Company that it has initiated important software integration work; engaged regulatory agencies on appropriate development steps via the 510(k) pathway; formalized a distribution relationship with Fortec Medical (https://www.fortecmedical.com), which has access to over 2700 hospitals in the U.S.; and identified key opinion leaders to serve in scientific advisory capacities. BeaMed anticipates additional value-added events to occur as it aims to reshape laser guided surgery with its unique directed laser technology system.
More information on BeaMed can be found on its company website and via a presentation by BeaMed management introducing the company, at the links below.
BeaMed company website:
https://www.beam-med.com
BeaMed management introduction to company:
https://www.youtube.com/channel/UCyoklsj7NfFMpPzC81sXzHg
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including without limitation that compounds and devices may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
mailto://info@ipharminc.com
SOURCE: Innovation Pharmaceuticals Inc.
View source version on accesswire.com:
https://www.accesswire.com/715729/Innovation-Pharmaceuticals-Investment-in-BT-BeaMedical-Helping-Advance-New-Surgical-Laser-Platform
NEWS -- Nanomix Enters into Distribution Agreement for the eLab System and Future New Products with IPS Genomix s.a.l. in the Middle East
SAN LEANDRO, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has entered into a distribution agreement with IPS Genomix s.a.l. (“IPS”), a medical diagnostics distributor with offices in Beirut, Lebanon and Dubai, UAE. IPS will market and distribute the Nanomix eLab® system, including the Nanomix S1 Panel assay and future, new test products for the eLab system, in multiple countries throughout the Middle East.
Ahmed Yacout, Chief Executive Officer of IPS, stated, “Improving sepsis patient diagnosis and outcome improvements is a serious need in the regions we serve. We are actively working with Nanomix to move forward this important solution with an aggressive launch effort planned in four countries in the Middle East as early as this month.”
John Hardesky, Chief Commercial Officer of Nanomix, stated, “Adding IPS, and the Middle East, to our growing distribution portfolio will serve Nanomix to accelerate our commercial roll-out of the eLab system. IPS has a long history of successfully introducing new diagnostic technologies to its strong customer base throughout the region.”
Dr. Thomas Schlumpberger, Chief Executive Officer of Nanomix, said, “We are thrilled to work with IPS in rolling out our S-1 Critical Infection assay panel and future products in the Middle East. I have worked successfully with IPS in the past and it’s a pleasure to work with them again.”
The Nanomix S-1 panel is designed to provide rapid test results for an aid in diagnosing critical infections including Sepsis. Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. The S1 Panel Assay was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About IPS Genomix.
IPS Genomix was founded in 2013 by a group of experts who have been in the healthcare domain for more than 25 years in the Middle East and Africa territory. IPS Genomix partners with US and European molecular diagnostic companies, to provide a diversification of genomic testing services focused on improving patient care utilizing the latest technologies of prognostic, predictive & personalized medicine. The treating physician can then individualize the treatment of his patients to enhance the prevention and/or treatment of certain conditions and cancer diseases. Given the rapid evolution of this particular field, IPS Genomix constantly incorporates new technology platforms and assays to offer physicians and their patients with the most up to date, reliable and cutting-edge personalized medicine tools.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- FuelPositive to Present at H.C. Wainwright 24th Global Investment Conference
September 12 2022 - 08:24AM
FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”) will be addressing the attendees of the H.C. Wainwright 24th Global Investment Conference being held in New York from September 12 to 14, 2022. Ian Clifford, FuelPositive’s Chief Executive Officer & Board Chair, will be providing a corporate update to conference attendees, as well as meeting with a series of registered investors, both in person and virtually. FuelPositive’s onsite, containerized green ammonia production system will be the main focus of the presentation.
The FuelPositive address to the full conference is scheduled for September 12, 2022 at 3 p.m. ET. The presentation will be recorded on video and posted to the conference and FuelPositive websites in the days following the conference.
To register for the conference and book a meeting with FuelPositive, follow this link: https://hcwevents.com/annualconference/.
About FuelPositive
FuelPositive?is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean technology solutions, including an on-site, containerized green ammonia (NH3) production system that eliminates carbon emissions from the production of the green ammonia. By focusing on technologies that are clean, sustainable and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented in the short term.
The FuelPositive onsite, containerized green ammonia production system produces pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green ammonia is also considered a key enabler of the hydrogen economy. The system comprises a nitrogen generator to produce nitrogen from air, a water electrolyser to produce hydrogen from water, and a patent-pending synthesis converter to produce green ammonia from the hydrogen and nitrogen.
FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-users energy and supply security while cutting carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional ammonia produced today as fertilizer.
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) accept 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 of 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 Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://mailbox1@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- Tokens.com CEO to Speak at Elevate Festival
TORONTO, September 12, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the metaverse and NFTs, today announces that its CEO, Andrew Kiguel, will be speaking at Elevate Festival 2022, the largest festival in Canada at the intersection of arts and technology. He will be speaking alongside industry leaders and innovators, including Serena Williams, Michele Romanow, Chris Hadfield and John Ruffalo.
Founded in 2017, Elevate Festival is the largest festival of its kind in Canada with a speaker roster of global innovators including Michelle Obama, Mark Cuban and Whitney Wolf Herd. This year’s festival is taking place in Toronto from September 20th - 22nd, 2022.
As a leader in the global Web3 blockchain ecosystem, Token.com’s CEO, Andrew Kiguel, has been asked to speak at Elevate. He will be sharing a presentation on the evolution of blockchain technology, from bitcoin to Web3. The talk will educate the audience on the basics of blockchain and introduce them to Tokens.com. Andrew will be speaking at the Design Exchange Building on September 21st, 2022 at 12:20pm.
"I’m honoured to have been asked to speak at this year’s Elevate Festival," said Tokens.com CEO, Andrew Kiguel. "The event will introduce Tokens.com to a new audience of potential investors, and help Canadians better understand blockchain and Web3."
For more information on the Elevate Festival please visit https://elevatefestival.ca/.
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005161/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Tokens.com CEO to Speak at Elevate Festival
TORONTO, September 12, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the metaverse and NFTs, today announces that its CEO, Andrew Kiguel, will be speaking at Elevate Festival 2022, the largest festival in Canada at the intersection of arts and technology. He will be speaking alongside industry leaders and innovators, including Serena Williams, Michele Romanow, Chris Hadfield and John Ruffalo.
Founded in 2017, Elevate Festival is the largest festival of its kind in Canada with a speaker roster of global innovators including Michelle Obama, Mark Cuban and Whitney Wolf Herd. This year’s festival is taking place in Toronto from September 20th - 22nd, 2022.
As a leader in the global Web3 blockchain ecosystem, Token.com’s CEO, Andrew Kiguel, has been asked to speak at Elevate. He will be sharing a presentation on the evolution of blockchain technology, from bitcoin to Web3. The talk will educate the audience on the basics of blockchain and introduce them to Tokens.com. Andrew will be speaking at the Design Exchange Building on September 21st, 2022 at 12:20pm.
"I’m honoured to have been asked to speak at this year’s Elevate Festival," said Tokens.com CEO, Andrew Kiguel. "The event will introduce Tokens.com to a new audience of potential investors, and help Canadians better understand blockchain and Web3."
For more information on the Elevate Festival please visit https://elevatefestival.ca/.
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005161/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Plus Therapeutics Presents Positive Phase 1 Data from ReSPECT-GBM Clinical Trial at the European Society for Medical Oncology Congress 2022
Phase 1 data indicates that direct administration of 186RNL targeted radiotherapeutic is safe in patients with recurrent glioblastoma
Statistically significant overall survival benefit observed with 186RNL radiation doses over 100 Gray
NIH-funded trial moving to Phase 2 to explore expanded dosing parameters, treat larger tumor sizes, and gather additional safety and efficacy data, that will support a future registrational trial
AUSTIN, Texas, Sept. 12, 2022 (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 Phase 1 data from the ReSPECT-GBM Phase 1/2a dose escalation clinical trial evaluating the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), in recurrent glioblastoma (GBM) in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022, being held September 9-13, 2022 in Paris, France.
“Radiation is lethal to cancer cells and rhenium-186 is an ideal radioisotope for the treatment of glioblastoma. Furthermore, the unique drug formulation allows the radiation to stay in the brain for days, if not weeks,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. “In the ReSPECT-GBM Phase 1 trial, we achieved up to 20 times the amount of radiation compared to external beam radiation therapy, and we observed a statistically significant improvement in survival in those patients receiving a therapeutic dose of radiation compared to those that did not.”
The oral presentation titled, The ReSPECT-GBM Phase 1/2a Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma via Convection Enhanced Delivery (CED) & Planned Phase 2b Trial [2770], reviews data from the Phase 1 ReSPECT-GBM trial which evaluated 23 adult patients with recurrent GBM across 8 cohorts of increasing dose and treated over a seven-year period.
Key findings include:
NEWS -- Plus Therapeutics to Present In-Person at the H.C. Wainwright 24th Annual Global Investment Conference
AUSTIN, Texas, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, will present in-person at the H.C. Wainwright 24th Annual Global Investment Conference on Wednesday, September 14, 2022, at 2:00 p.m. ET, and host investor meetings. The conference is being held at the Lotte New York Palace Hotel in New York City.
Investors interested in arranging an in-person meeting with the Company’s management during the conference should contact the H.C. Wainwright conference coordinator. An archived replay of the presentation will be available under the Events tab of the Plus Therapeutics website at https://www.plustherapeutics.com for 90 days following the event.
About Plus Therapeutics
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,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
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 cancer diagnostics and therapeutics 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 -- Oncolytics Biotech® Appoints Jonathan Rigby to its Board of Directors
Mr. Rigby is the Group Chief Executive Officer of Revolo Biotherapeutics and has three decades of experience in the pharmaceutical and biotechnology industries
SAN DIEGO and CALGARY, AB, Sept. 7, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the appointment of Jonathan Rigby to its Board of Directors.
"Jonathan has successfully built, financed, listed, and led several life science companies across a range of therapeutic areas, and I am thrilled to welcome him to our Board," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "His extensive executive leadership experience, together with his business development and commercial expertise, will guide us as we advance our breast and pancreatic cancer programs towards late-stage trials and work to deepen our relationships with leading biopharmaceutical companies. His background is highly complementary with those of our other Board members, and I look forward to beginning our work together."
Mr. Rigby added, "The opportunity to join Oncolytics at this crucial stage in the Company's evolution and help forge the Company forward to treat these terrible cancers is compelling. Extensive clinical data have demonstrated pelareorep's ability to provide a statistically significant survival benefit in breast cancer, its potential to synergize with checkpoint inhibition and drive objective responses in pancreatic cancer, as well as how its multifaceted mechanism of action positions it to enhance the efficacy of additional drug classes across various indications. Upcoming data readouts in breast and pancreatic cancer will provide valuable opportunities to accelerate pelareorep's path towards registration in these indications. I am keen to lend my insights to company management and the Board as they work towards these potential catalysts and prepare for anticipated growth."
Mr. Rigby joins Oncolytics' Board with over three decades of experience in the pharmaceutical and biotechnology industries. He is currently the Group Chief Executive Officer (CEO) of Revolo Biotherapeutics, where he leads a team focused on the development of therapies for autoimmune and allergic diseases. Previously, he was the CEO of SteadyMed Ltd., which he led through a NASDAQ listing and sale to United Therapeutics Corporation. Prior to his time at SteadyMed, Mr. Rigby co-founded Zogenix, Inc., a CNS-focused specialty pharmaceutical company that was acquired by UCB earlier this year in a transaction valued at up to approximately U.S. $1.9 billion. Before co-founding Zogenix, Mr. Rigby held roles of increasing responsibility in commercial and business development functions at large pharmaceutical companies such as Merck, Bristol Myers Squibb, and Profile Therapeutics (now Phillips Medical). In addition to his Oncolytics appointment, Mr. Rigby is also a member of the Revolo Biotherapeutics and ImmunoMolecular Therapeutics Boards of Directors and the Chairman of BIOS, a Nasdaq-listed biotech acquisition company. He holds a B.S. with Honors in Biological Sciences from Sheffield University, UK, and an M.B.A. from Portsmouth University, UK.
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 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 plans to advance towards a registration study in metastatic breast cancer; 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-appoints-jonathan-rigby-to-its-board-of-directors-301618920.html
SOURCE Oncolytics Biotech® Inc.
I have got it working now! I just needed to log off Ihub and then log in again. Just stupid me, I guess. If anyone who tried looking into this, thanks.
This may be new or maybe not. I can log into any Ihub board with no problems, but when I try to get into the Streamer it acts like I haven't logged in yet. So I log in and try to do the Streamer again, and it throws me back to the "Please Login" prompt again. Any ideas -- I need my Streamer! Everything was working fine last week. Help.
NEWS -- Plus Therapeutics Announces FDA Meeting Summary for Lead Drug Candidate
NIH-funded ReSPECT-GBM Phase 2 trial to start in 2022
ReSPECT-GBM Phase 2 to focus on 186RNL dose expansion, safety and efficacy data to support future registrational trial
AUSTIN, Texas, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, announced today a summary of its Type C Clinical meeting minutes with the U.S. Food and Drug Administration (FDA) relating to its lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with recurrent glioblastoma (GBM).
The FDA and Plus Therapeutics agreed that the ReSPECT-GBM clinical trial should proceed to the planned Phase 2. The key focus areas of clinical investigation of the Phase 2 trial will be: 1) further dose exploration, including both increased dosing and multiple doses, and 2) collecting additional safety and efficacy data to inform the design of the future registrational trial. Furthermore, there was agreement that in a planned future registrational trial, overall survival should be used as the primary endpoint. The Company and the FDA also agreed to hold future meeting(s) to consider the use of external data to augment the control arm in the registrational trial.
“Our first formal FDA clinical meeting after in-licensing the Rhenium NanoLiposome radiotherapeutic platform was an important milestone for us,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We received clear feedback and, as a result, we intend to begin the ReSPECT-GBM Phase 2 trial utilizing our cGMP 186RNL drug, which should begin later this year. We will provide more details in our moderated oral presentation at the European Society for Medical Oncology (ESMO) Congress later this month.”
In August 2022, the Company reported FDA feedback on its Chemistry, Manufacturing and Controls (CMC) focused Type C meeting. Planned cGMP production of 186RNL targeted radiotherapeutic is expected to begin in the second half of 2022 to support the ReSPECT Phase 2 clinical trial. On September 9, 2022, the ReSPECT-GBM trial principal investigator, Andrew Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio, will provide a full update on the Phase 1 trial and discuss the clinical development overview during the ESMO Congress.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for adults and children with rare and difficult-to-treat cancers. Our proprietary radiotherapeutic platform is centered around the precise delivery of powerful doses of rhenium, a beta-gamma emitting radioisotope that irradiates and kills tumor cells using novel microsphere and nanoliposome technologies. Our radiotherapeutics are designed and intended to potentially offer enhanced safety, efficacy and convenience for patients and healthcare providers. The 186RNL development programs for recurrent glioblastoma and leptomeningeal metastases are supported, in part, by the U.S. National Institutes of Health (NIH) and the Cancer Prevention and Research Institute of Texas (CPRIT), respectively. 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,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
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 cancer diagnostics and therapeutics 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
New video podcast intervi8ewing Ian Clifford of FuelPositive
9/4/22
NEWS -- Nanomix Announces Agreement with Mobility Health to Co-Develop a Lab Development Test for Evaluating Levels of COVID-19 Circulating Antibodies
NEWS -- Navidea Biopharmaceuticals Announces Opening of Nine New Sites in its Pivotal Phase 3 Trial in Rheumatoid Arthritis and Termination of Binding Memorandum of Understanding with Jubilant Radiopharma
DUBLIN, Ohio, September 01, 2022--(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 opening of nine additional sites for recruitment into its pivotal NAV3-33 Phase 3 clinical trial titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)." A total of 12 sites open for the NAV3-33 study will enable faster patient enrollment and data gathering.
This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis ("RA") patients switching to an anti-TNFa therapy. Trial details are posted on clinicaltrials.gov.
RA is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients initiating new RA therapies over a course of three to six months and, in those patients for which the new therapies prove to be ineffective, to change their treatments to an alternative therapy with a different mechanism of action. This trial-and-error process of appropriate treatment selection may take several months to more than a year to arrive at an adequate treatment for any RA patient. Imaging with Tc99m tilmanocept, a synthetic molecule with high affinity to CD206 receptors expressed on activated macrophages, offers the potential to provide an early predictor of clinical response by providing an objective, quantifiable readout of changes in macrophage density in the joints of patients undergoing initiation or change of therapy. These macrophage density changes may be observable weeks before disease modification can be detected with standard clinical assessments and are predictive of treatment response.
Tilmanocept imaging could provide rheumatologists and those suffering from RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working, and this could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is currently possible.
The Company also announced the termination of the Memorandum of Understanding ("MOU") with Jubilant Radiopharma, originally signed on August 9, 2020. The MOU with Jubilant Radiopharma outlined the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s diagnostic imaging agent Tc99m tilmanocept (technetium Tc99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period. Since the original signing of the MOU, Navidea has advanced Tc99m tilmanocept for indications in RA through its Phase 2B proof of concept trial and into the currently enrolling Phase 3 trial as well as the Phase 2B tilmanocept joint localization to joint biopsy study.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We have generated significant data in support of our hypotheses that Tc99m tilmanocept can provide early prediction of treatment response to anti-TNFa therapy in RA, and we look forward to the completion of the RA trials. The additional new sites we have opened will help significantly in this process." Dr. Rosol continued, "Moving forward unencumbered by the exclusivity agreement, we now have the opportunity to discuss partnerships with other companies whose long-term interests align with our global business development strategy as we continue to advance towards U.S. Food and Drug Administration New Drug Application submission and beyond."
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 enabling 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 http://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/20220901005305/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Oral Ruling in Case Involving Attorney’s Fees
September 01 2022 - 08:00AM
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on August 30, 2022, the District Court of Harris County, Texas (the “Court”) made an oral ruling from the bench in open court at the conclusion of the trial in Case No. 2018-24442-151; Capital Royalty Partners II, L.P. et al. v. Navidea Biopharmaceuticals, Inc. and Macrophage Therapeutics, Inc., awarding Capital Royalty Group (“CRG”) $2,572,937.61 in attorney’s fees on their breach of contract claims against Navidea and Macrophage Therapeutics (“MT”).
The Court’s oral ruling did not set out the findings and conclusions made by the Court in support of the ruling; however, on November 21, 2021, the Court entered an Interlocutory Summary Judgment against Navidea and MT, ruling breach of the Global Settlement Agreement in seeking reconsideration and an appeal of the Amended Final Judgment entered by the Court in the prior case among the parties, Case No. 2016-22242-151; Capital Royalty Partners II, L.P. et al. v. Navidea Biopharmaceuticals, Inc. and Macrophage Therapeutics, Inc., and by pursuing a suit against CRG in the State of Ohio. A formal written final judgment will be entered by the Court in the case in the near future.
Navidea is disappointed in the Court’s ruling and does not believe the law and the facts presented at the trial support the ruling against it. Once a final written judgment identifying the basis and reasoning in support of the trial court’s decision is received, Navidea can better assess the Court’s judgment and determine what course of action to pursue in response to the court’s ruling.
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 enabling 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 http://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/20220901005290/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Nanomix Appoints Industry Veteran Tadd S. Lazarus, M.D., to the Board of Directors
SAN LEANDRO, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced the appointment of Tadd S. Lazarus, M.D., to the Board of Directors as an independent director.
“We are extremely pleased to welcome Tadd S. Lazarus, M.D., to the board and leadership of the Company,” said Dr. Thomas Schlumpberger, CEO of Nanomix. “His medical leadership will be of great value for commercializing the current Nanomix critical infection assay panel as well as for developing new products on the Nanomix platform, the eLab.”
“Dr. Lazarus brings an important medical and industry perspective to the Nanomix Board,” said Garrett Gruener, Chairman of the Nanomix Board of Directors. “Tadd’s input and counsel will be very valuable as we accelerate our commercial efforts and broaden our product portfolio.”
“I am thrilled about working with the Nanomix team to fully develop the exciting eLab mobile diagnostics testing platform. The Nanomix goal to improve Point of Care testing for critical conditions will meet an important and growing need in the medical community,” said Tadd S. Lazarus, MD.
Dr. Lazarus has led multiple organizations as Chief Medical Officer encompassing biochemistry, medical diagnostics, and patient services arenas. Companies include Achieve Health Management, Inivata Inc., and Clinical Genomics. He served as Chief Medical Officer and Head of Medical & Scientific Affairs, Reimbursement, and Public Policy at Qiagen from 2013 through 2016. In 2010, Lazarus was at Gen-Probe Inc., (now Hologic), as Chief Medical Officer and VP of Clinical Affairs, where he was responsible for a 42-person team dedicated to clinical trials. Lazarus began his career at Roche Diagnostics, where he held simultaneous roles in private practice and as Director of Medical and Scientific Affairs, and then as the North American Medical Director for the molecular diagnostics, POC, diabetes, clinical chemistry, and immunology lines of business. Dr. Lazarus received a Bachelor of Science in Biology & Physiology from Marlboro College and earned his Medical Degree from Ross University School of Medicine.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- FuelPositive Announces Filing of Quarterly Report and Provides Early Pre-Sales Update
TORONTO, Aug. 30, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce that it has filed its quarterly interim financial statements and accompanying management’s discussion and analysis for the nine-month period ended June 30, 2022. Copies of the materials are available publicly under the profile for the Company on the SEDAR website (https://www.sedar.com). The Company is also pleased to provide the following update regarding its first demonstration project and pre-sales activity.
Demonstration Project
As announced on August 4, 2022, validation has begun on the first demonstration system and is expected to be completed in November 2022. The system, which will be contained in three 20-foot containers, will be placed on an 11,000-acre family-operated crop farm in Manitoba, operated by Tracy and Curtis Hiebert.
The hydrogen separator and nitrogen extractor, which comprise 60 per cent of the entire system, were validated ahead of schedule, prior to being shipped to the Company’s Ontario facility. Rate of production and purity surpassed expectations, giving the Company the confidence to open up to farmers for pre-sales on August 10, 2022. A price for customers of CA$950,000 was also announced on August 4, 2022.
The building of FuelPositive’s patent-pending ammonia synthesis convertor continues to be on track for completion in November 2022.
Pre-Sales
“The level of interest in pre-sales serves as a strong indicator of demand. We are seeing a high level of interest in our onsite model, as we expected, because of the stability it gives farmers over supply, timing and price. Our process is to have an introductory call with interested farmers to talk about their application, objectives and the conditions on their farms. We’ve had daily expressions of interest and have completed many introductory calls already,” said Derek Boudreau, FuelPositive’s Strategic Advisor for Agricultural Implementation. “The qualification process involves many steps, including site visits to the farms. Preliminary qualification steps have been completed with many interested parties and we have begun booking our site visits to perform the evaluation of each interested party. Each inquiry represents the beginning of a potential long-term relationship – we want an extraordinary customer experience, which includes the site visit to get to know our customers’ needs, so we can provide the best solution possible.”
“The demand we are seeing is encouraging. We should be ready to provide an update in November about the size of our long-term manufacturing capacity planning. The volume of demand will guide us as we determine how large our mass manufacturing facility needs to be, as well as what our material and labour plans, production schedule and order fulfillment plans should be,” said FuelPositive Chief Operating Officer Nelson Leite.
FuelPositive has identified and secured land near its Waterloo, Ontario facility, with a land development partner who can build a custom-built factory for it. It is expected to be a large facility, up to 140,000 square feet on a nine-acre site. Building the factory will facilitate the switch from batch manufacturing to serial or assembly line manufacturing. “We’ll use this facility until we’ve reached capacity, and then, assuming the demand is there, we will create new facilities, as needed,” added Nelson Leite.
The Company is aiming to deliver its onsite, containerized Green Ammonia production systems within one growing season for the farmer so that once the farmer has committed to an order, the farmer is able to begin the next growing season with their system on their farm. Delivery will depend on the size of the system, location, and existing infrastructure at the farm site.
The FuelPositive Pre-Sales webpage can be found here: https://fuelpositive.com/pre-sales/.
Additional details about the onsite, containerized Green Ammonia production system can be found here: https://fuelpositive.com/green-ammonia-system/
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean technology solutions, including an on-site, containerized green ammonia (NH3) production system for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, sustainable, and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented in the short term.
The FuelPositive containerized green ammonia production system produces pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells, and a solution for grid storage. Green ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-users energy and supply security while cutting carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional ammonia produced today as fertilizer.
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) accept 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 of 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 Investor inquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://mailbox1@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media inquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
NEWS -- Navidea Biopharmaceuticals Announces Closing of its Rights Offering and Second Quarter 2022 Earnings Conference Call and Business Update
August 30 2022 - 09:30AM
Conference Call to be Held on Thursday, September 8, 2022 at 4:00 p.m. (EDT)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announced today the closing of its rights offering and the final results thereof.
Navidea received aggregate gross cash proceeds of approximately $6.2 million in the rights offering. If exercised, additional gross proceeds of up to $11.6 million may be received through the exercise of warrants issued in the rights offering. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.50 per share. In order to help maximize Navidea’s ability to use its net operating losses and other tax benefits in future years, Navidea’s board exercised its discretion to limit the number of units that John K. Scott, Jr., vice chairman of Navidea’s board, could purchase pursuant to the exchange and cancellation of his shares of Series F and Series G preferred stock. The rights offering resulted in the sale of 4,250 units pursuant to the exchange and cancellation of all outstanding shares of Navidea’s Series D and Series F preferred stock and no shares of Series G preferred stock were permitted to be exchanged by Mr. Scott.
Maxim Group LLC acted as dealer-manager for the rights offering.
The rights offering was made pursuant to the Company's registration statement on Form S-1, which was declared effective by the U.S. Securities and Exchange Commission on August 3, 2022, and the prospectus supplement dated August 18, 2022. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on August 24, 2022, have expired.
The Company also announced it will host a conference call and webcast on Thursday, September 8, 2022 at 4:00 p.m. (EDT) to discuss the rights offering, clinical developments and financial results for the second quarter ended June 30, 2022.
Dr. Michael Rosol, Chief Medical Officer, Erika Eves, Vice President of Finance and Administration, Alexander Cappello, Board Chair, and John K. Scott, Jr., Board Vice Chair, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Second Quarter 2022 Earnings Conference Call and Business Update
Date: Thursday, September 8, 2022
Time: 4:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13732617
Webcast Link: https://www.webcast-eqs.com/navidbioph20220908/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.
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.
Note on 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, whether stated or implied, regarding our planned rights offering, financing plans and other future events. Words such as "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond our control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; 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. We undertake no obligation to update publicly or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220829005246/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Plus Therapeutics Announces Summary of FDA Meeting on Company’s cGMP Manufacturing Process for Lead Drug Candidate
August 29 2022 - 07:00AM
GlobeNewswire Inc.
Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, announced today an update following receipt of formal minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) specific to Chemistry, Manufacturing and Controls (CMC). The meeting focused on the Company’s Current Good Manufacturing Practice (cGMP) clinical and commercial manufacturing process for its lead investigational targeted radiotherapeutic, BMEDA-chelated Rhenium-186 NanoLiposome (186RNL), for recurrent glioblastoma (GBM).
The FDA indicated agreement with the Company’s proposed application of cGMP guidance for radiotherapeutics, small molecule drug products and liposome drug products for Plus Therapeutics’ novel 186RNL in support of ongoing and future glioblastoma clinical trials, manufacturing scale up and commercialization. Alignment with the FDA includes support of the Company’s proposed controls and release strategy for the new drug substance and new drug product. The Company expects that this FDA feedback will apply to 186RNL used in other clinical development programs, including leptomeningeal metastases and pediatric brain cancer.
“We had a constructive and detailed discussion with the FDA and obtained clarity on various key CMC requirements to mitigate the risk of future delays for potential Investigational New Drug and New Drug Applications,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The Company remains on track, on time and on budget to have cGMP 186RNL available in the second half of 2022 for all ongoing and planned ReSPECT™ clinical trials.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for adults and children with rare and difficult-to-treat cancers. Our proprietary radiotherapeutic platform is centered around the precise delivery of powerful doses of rhenium, a beta-gamma emitting radioisotope that irradiates and kills tumor cells using novel microsphere and nanoliposome technologies. Our radiotherapeutics are designed and intended to potentially offer enhanced safety, efficacy and convenience for patients and healthcare providers. The 186RNL development programs for recurrent glioblastoma and leptomeningeal metastases are supported, in part, by the U.S. National Institutes of Health (NIH) and the Cancer Prevention and Research Institute of Texas (CPRIT), respectively. 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,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
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 cancer diagnostics and therapeutics 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 -- Navidea Biopharmaceuticals Announces Subscriptions of Approximately $14.2 Million from its Rights Offering
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announced today the preliminary results of its rights offering which expired at 5:00 P.M. Eastern Time on August 24, 2022. The Company estimates that the rights offering will result in total subscriptions of approximately $14.2 million. Navidea expects to receive from the rights offering aggregate gross cash proceeds of approximately $6.1 million (excluding additional proceeds of up to $15.8 million from the exercise of warrants issued in the rights offering, if any such exercises occur), and the exchange and cancellation of all of its outstanding shares of Series D, Series F and Series G preferred stock having an aggregate fair market value of $8.05 million, plus accrued dividends. The results of the rights offering are preliminary and subject to change pending finalization and verification by Navidea and its subscription agent, Broadridge Corporate Issuer Solutions, Inc.
Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one (1) share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.45 per share) and one (1) warrant to purchase 2,222 shares of Navidea’s common stock with an exercise price of $0.50 per share.
Navidea anticipates that closing of the rights offering will occur on or about August 29, 2022, subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book-entry form or through the facilities of DTC, as applicable, shares of its Series I convertible preferred stock and warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.
Maxim Group LLC acted as dealer-manager for the rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at mailto://syndicate@maximgrp.com or telephone at (212) 895-3745.
The Company's registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on August 3, 2022. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC's web site at http://www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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.
Note on 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, whether stated or implied, regarding our planned rights offering, financing plans and other future events. Words such as "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond our control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; 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. We undertake no obligation to update publicly or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220825005466/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Operational Improvements Drive Tytan Cybernetics to Record Q2 2022 Results and 4th Consecutive Quarterly Profitability. With YTD Revenue Growth of 144% YoY, Tytan Reported YTD Net Income Growth of Over 1,330% YoY to $1.57 million.
TORRANCE, Aug. 23, 2022 (GLOBE NEWSWIRE) -- Tytan Cybernetics/Video River Networks “the Company” (OTC: NIHK), an innovative holding company for electric vehicle technology, fintech, AI, robotics, drones, distressed assets, and business opportunities within the high growth, fintech, AI, health, sports and entertainment industries, reports fourth consecutive quarter of profitability.
The Company also reported record second quarter 2022 results, leading to net income for the quarter of $0.97 million, impressive YTD revenue growth of 144.18% YoY to $9.87 million. YTD net income from operations exploded by 1,330.66% YoY to $1.57 million, driven by financial and operational improvements across all its lines of businesses.
Management Commentary
"We continue to see financial and operational improvements, which allowed us to deliver another quarter of profitability," said Frank I Igwealor, President and CEO of Tytan Cybernetics, Inc. "As we grow our business lines to unlock new growth avenues, our strategy to generate operational efficiencies is also taking hold, as reflected by our notable year-over-year and sequential improvements in Net Income during the quarter. We are pleased to see our financial engineering-based approach to enhancing our shareholders’ value take effect, which will allow us to have greater financial flexibility to conduct mergers and acquisition in the quarters ahead. I look forward to the remainder of 2022, which is shaping up to be a strong year for Tytan Cybernetics as we work diligently to generate long-term value for our stakeholders."
First Quarter 2022 Financial Results
NEWS -- Nanomix Enters into Distribution Agreement for the eLab System and Future New Products with BIOASIA PTE LTD in Singapore
SAN LEANDRO, Calif., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has entered into a distribution agreement with BIOASIA PTE LTD (“Bioasia”), a medical diagnostics distributor located in Singapore. Bioasia will market and distribute the Nanomix eLab® system in Singapore and Brunei, including the Nanomix S1 Panel assay and future new test products for the eLab system.
Henry Lim, Managing Director of Bioasia, commented, “We are pleased to introduce and give access to much needed, new diagnostics to our hospitals and customers. Sepsis and critical infections are a challenge in Singapore in the same way they are around the world. Our partnership with Nanomix will help us bring a unique option to our customers and the healthcare system in Singapore.”
Thomas Schlumpberger, Chief Executive Officer of Nanomix, stated, “Nanomix is at the cusp of commercialization and continues to show early successes in executing upon our commercialization strategy. We are excited to see increased interest in our products especially in Asia, beginning in Singapore, which represents a significant and untapped growth opportunity for Nanomix.”
John Hardesky, Chief Commercial Officer of Nanomix, stated, “Singapore has been ranked as one of the most efficient healthcare systems in the world for many years. The Nanomix eLab® analyzer runs the S1 Panel assay rapidly, diagnosing critical infections including sepsis in 12 minutes which will undoubtedly lead to breakthroughs in earlier sepsis patient diagnosis.”
Sepsis is a recognized global health crisis. Early identification and treatment are a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About BIOASIA PTE LTD.
Bioasia was established in 2005 focusing on medical marketing and distribution of critical care products and monitoring equipment for patients requiring intensive care in intensive care settings. Our staff are professional biomedical engineers with knowledge of ISO13485. We work with medical professionals in hospital settings to ensure in-hospital equipment are at optimal working conditions for effective patient monitoring and results. Bioasia has represented various medical device companies in Singapore and Brunei markets since 2005. Bioasia is GDPMDS certified.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- Plus Therapeutics to Present Data from ReSPECT-GBM™ Clinical Trial at the European Society for Medical Oncology Congress 2022
AUSTIN, Texas, Aug. 23, 2022 (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 it will present data from the Phase 1/2a ReSPECT-GBM™ dose escalation clinical trial evaluating the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), in recurrent glioblastoma in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022, being held September 9-13, 2022 in Paris, France.
Details of the oral presentation:
Proffered Paper abstracts accepted for oral presentation at ESMO 2022 will be published online via the ESMO website at 00:05 CEST on September 5, 2022 (6:05 p.m. EDT on September 4, 2022). For more information visit https://www.esmo.org/meetings/esmo-congress-2022.
A copy of the presentation will also be available under the Presentations tab of the Investors section of the Company’s website at the time of presentation at https://ir.plustherapeutics.com.
About Plus Therapeutics
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,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
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 cancer diagnostics and therapeutics 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 -- NightHawk Biosciences Announces Buildout of Advanced Biosafety Level 2 (BSL-2) Laboratory
NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced the construction of an advanced biosafety level 2 (BSL-2) laboratory, adding biodefense and infectious disease capabilities to the Company’s research facilities in Research Triangle Park, North Carolina.
Jeff Wolf, NightHawk’s CEO, commented, “Given the unprecedented global biological threats facing our nation, both natural and man-made, this new, state-of-the-art BSL-2 laboratory will enable us to work with select attenuated agents such as anthrax and botulinum toxins, tularemia, monkeypox and other priority DOD agents and pathogens of global concern. The buildout of this facility follows our acquisition of biodefense company Elusys Therapeutics and represents the next stage in our efforts to develop medical countermeasures to protect the population against emerging biothreats.”
Matthew M. Seavey, PhD, Vice President of Research of NightHawk commented, “This new BSL-2 facility is being designed to accommodate research on high-priority infectious agents. As such, we are implementing strict safety measures within this facility, including enhanced safety monitoring, independent powered air filtration units (PAPR), HEPA filtered unidirectional HVAC units, and high security restricted access for secure entry, all measures that are critical for the BSL-2 classification. In addition, we have increased our vivarium footprint, allowing us to execute and enhance data generation related to infectious disease preclinical studies, in order to evaluate the efficacy, immunogenicity, and safety of vaccines and therapeutics against bacterial and viral pathogens.”
NightHawk Biosciences, Inc.
NightHawk Biosciences is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through commercialization. The Company leverages its integrated ecosystem of subsidiaries to accelerate the development of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.
For more information on the Company and its subsidiaries, please visit: https://www.nighthawkbio.com, and also follow us on Twitter.
Forward Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as the state-of-the-art BSL-2 laboratory enabling us to work with select attenuated agents such as anthrax and botulinum toxins, tularemia, monkeypox and other priority DOD agents and pathogens of global concern, and increasing the Company’s vivarium footprint, allowing it to execute and enhance data generation related to infectious disease preclinical studies, in order to evaluate the efficacy, immunogenicity, and safety of vaccines and therapeutics against bacterial and viral pathogens. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to work with select attenuated agents such as anthrax and botulinum toxins, tularemia, monkeypox and other priority DOD agents and pathogens of global concern at the state-of-the-art BSL-2 laboratory and the Company’s ability to execute and enhance data generation related to infectious disease preclinical studies, in order to evaluate the efficacy, immunogenicity, and safety of vaccines and therapeutics against bacterial and viral pathogens, NightHawk’s ability to commence operation in San Antonio and Kansas when anticipated and to successfully operate as a CDMO, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, NightHawk’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of NightHawk’s products, developments by competitors that render such products obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
NEWS -- Nanomix Announces ISO 13485:2016 Certification for its New Facility in San Leandro, CA
SAN LEANDRO, Calif., Aug. 18, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in mobile, affordable, point-of-care diagnostics, today announced that it has received ISO 13485:2016 certification for its new facility in San Leandro, California.
Nanomix began the transition to its new manufacturing facility in April 2022. The new facility is 9327ft2 and accommodates the Company’s increasing headcount. Investment in the facility includes additional automation that expands immediate capacity and allows significant flexibility for demand-driven scaling of the Nanomix proprietary, multiplex cartridge technology and tests.
Vidur Sahney, Chief Operating Officer of Nanomix, stated, “The receipt of the ISO certification validates and affirms the strong quality system Nanomix has in place. Additionally, this is a major milestone and the result of a successful transfer of our manufacturing technology to our new facility. Notably, this ISO certification marks the continuation and acceleration of our manufacturing scaling to meet customer demand for the eLab S1 critical infection panel and other future products.”
ISO 13485:2016 an internationally recognized quality standard that is intended to ensure that medical devices and related services have consistent design, development, production, and sale of products that are fit for purpose as per intended use. To be certified, organizations must demonstrate that their Quality Management Systems are able to provide products and related services that consistently meet customer and applicable regulatory requirements.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- Plus Therapeutics Awarded $17.6 Million from State of Texas
Funding from the Cancer Prevention and Research Institute of Texas (CPRIT), the second largest global public funder of cancer research, will support the majority of the development costs of 186RNL for leptomeningeal metastases.
AUSTIN, Texas, Aug. 17, 2022 (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 was awarded a $17.6 million Product Development Research grant by the Cancer Prevention and Research Institute of Texas (CPRIT) to fund the continued development of the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with leptomeningeal metastases (LM).
“The Plus team is honored to receive this significant and esteemed award from CPRIT,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We expect that the non-dilutive funding from CPRIT will come on-line next month once the award agreement is finalized and this will significantly offset our longer-term, three-year capital requirements for the advancement of our LM program.”
In the second quarter of 2022, the Company completed enrollment of Cohort 1 in the ReSPECT-LM Phase 1/2a dose escalation trial (NCT05034497). 186RNL was delivered without dose limiting toxicities in this initial cohort, and the independent Data and Safety Monitoring Board has approved the plan to move ahead with Cohort 2.
“LM is one of the most devastating and aggressive late-stage cancer complications, in which the primary cancer spreads to the central nervous system. The most common solid tumor giving rise to LM is breast cancer and LM affects 3% to 5% of women already suffering with breast cancer,” stated Jamil Rivers, President of METAvivor Research and Support, Inc. “The continued investment in clinical research and development for metastatic breast cancer, including leptomeningeal metastases, is critically important. We lose 115 people every day to metastatic breast cancer, which is unacceptable. Patients and their families experience significant burdens when faced with a metastatic breast cancer diagnosis. Research for treatments offers new hope to extend life for those diagnosed with LM.”
The U.S. Food and Drug Administration has granted Fast Track designation to 186RNL for the treatment of LM.
“Leptomeningeal metastases is a difficult and growing problem for patients with a variety of cancers and 186RNL represents a promising new potential option,” said Dr. Andrew Brenner, ReSPECT-LM Trial Principal Investigator. “Though still relatively early in development, the clinical data is compelling and I am pleased to see that CPRIT has recognized this novel therapy by virtue of this substantial award.”
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 263 distinguished researchers, supported the establishment, expansion or relocation of 44 companies to Texas and generated over $7.4 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.8 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at https://cprit.state.tx.us.
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,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” 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 potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM trial; possible negative effects of 186RNL; the continued evaluation of 186RNL for LM including through evaluations via a second patient cohort; capital requirements, timing and speed of development; and the intended functions of the Company’s platform and expected benefits from such functions.
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; changes in the CPRIT program; 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 -- AmmPower Corp. Response to Inflation Reduction Act (2022) and Proposed Hydrogen Tax Incentives
TORONTO, ON / ACCESSWIRE / August 17, 2022 / CSE:AMMP, OTCQB:AMMPF, FSE:601A / AmmPower Corp. (the "Company" or "AmmPower") announces that the Inflation Reduction Act of 2022 (H.R. 5376) (the "Act"), which was approved by the United States Congress and signed into law on August 16th, 2022, includes provisions that the Company believes will benefit owners of AmmPower's independent ammonia production systems, the IAMM™ units.
The Act includes several provisions to incentivize clean energy and clean hydrogen production through deductible tax credits. These credits will offset the operating costs associated with the production of green hydrogen, and therefore green ammonia. The Company believes its IAMM™ units will meet the qualifications listed in the Act, enabling owners of IAMM™ units to take advantage of the proposed tax credits. Some of these qualifications include:
NEWS -- Provectus Biopharmaceuticals Expands Sponsored Research Collaboration with University of Calgary (Canada) to Investigate Systemic Administration of Pharmaceutical-Grade Rose Bengal for Treatment of Pediatric Leukemia
KNOXVILLE, TN, Aug. 17, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has expanded its sponsored research program with Aru Narendran, MD, PhD, Professor, Departments of Pediatrics, Oncology, Biochemistry & Molecular Biology, and Physiology & Pharmacology at the Cumming School of Medicine of the University of Calgary in Calgary, Alberta, Canada to investigate systemic administration of Provectus’ pharmaceutical-grade rose bengal for the treatment of pediatric leukemia. The Company’s innovatively-assembled and proprietary rose bengal is the lead member of a class of small molecules called halogenated xanthenes.
As part of this new sponsored research, the Narendran team plans to:
NEWS -- Vivos Inc. Announces a New IsoPet® Precision Radionuclide Therapy Regional Clinic for Equine Therapy
Richland WA, Aug. 16, 2022 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to report that it just certified the New England Equine Practice in Patterson, NY to administer Precision Radionuclide IsoPet® therapy for treating solid tumors in horses.
IsoPet® is a next generation treatment option, providing a same day therapy, using relatively low activity to deliver a high therapeutic dose that stays at the injection site with no contamination in the urine or feces.
As we gain experience at our equine sites and gain the confidence of the regulators, we intend to expand their radioactive material handling license to allow the use of a mobile Isopet® therapy vehicle that can treat horses on their home farm. This is an important feature as horses should not be trailered more than eight hours or they can develop serious medical respiratory issues called “trailer fever” the following day.
Dr. Korenko stated, “We are in active discussions related to opening additional equine clinics and are excited about offering Isopet® as a game changing treatment option for treating solid tumors in horses.
We are also pleased to report that our first demonstration of Isopet® equine therapy at the University of Missouri regional clinic (Summer Solstice) remains cancer free after fifteen months.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable Precision Radionuclide Therapy 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 used 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 is required. 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 -- Tokens.com Reports Operating and Financial Results for Q2 2022
TORONTO, August 16, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and incubates businesses linked to the Metaverse and NFTs, is pleased to announce its operating and financial results for the three and six months ended June 30, 2022 ("Q2 2022").
All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q2 2022 Highlights:
NEWS -- Tokens.com Reports Operating and Financial Results for Q2 2022
TORONTO, August 16, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and incubates businesses linked to the Metaverse and NFTs, is pleased to announce its operating and financial results for the three and six months ended June 30, 2022 ("Q2 2022").
All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q2 2022 Highlights: