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NEWS -- Tokens.com Announces Key New Hires and Acquires New Crypto Gaming Assets
TORONTO, May 30, 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, is pleased to share that its subsidiary, Hulk Labs, has made several strategic hires and also acquired new gaming assets.
Hulk Labs has added James Hewitt, a P2E gaming expert and Alice Huang, Head of Operations, to the team.
Hulk Labs brought onboard a P2E gaming expert, James Hewitt, who has been conducting deep analysis and building in-depth calculators for the most interesting play-to-earn games for the past year. These tools will be used to advise game developers to improve their own economic models, and by investors (including Hulk Labs itself) to assess which games and strategies can provide the highest earnings potential. Hulk is in the process of integrating these calculators onto its own site at https://hulklabs.com - and will be available to the public in June 2022.
Alice Huang also joined Hulk Labs and Tokens.com as the Head of Operations. Alice is responsible for several initiatives at Hulk including scaling up the base of assets and managing relationships with new and existing games in the Hulk network. Alice has over 15 years of experience in operations, marketing and strategic partnership. Alice is also a published author in Web3.
Hulk Labs has also acquired play-to-earn crypto gaming assets in Crabada.
Crabada is an engaging play-to-earn (P2E) game where players can mine, loot, breed and battle. According to CoinGecko on April 26, 2022, "Crabada had more than 12,000 active wallets, making it the 24th most popular crypto game."
Crabada continues to gain traction with investors and players, with the game’s social media following on a steady uptrend - and a growing reputation as a fun game to play. Being able to make real money feels like a bonus to many players.
Crabada is also the most popular game built on the Avalanche blockchain, generating 64% of transactions on Avalanche at its peak.
Hulk Labs identifies and invests in games at pre-launch. We also provide guidance in tokenomics, marketing and gameplay for early stage P2E games to ensure the success of these projects.
"The Hulk Labs division was created to find exciting, new, and emerging projects with potential for outsized growth in the play-to-earn space. Despite the outback in the crypto market, we believe play-to-earn gaming is the future of online gaming and we want to be positioned to capitalize by attracting the best talent in the industry to our business," commented Andrew Kiguel, CEO of Tokens.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. 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.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
Crabada
Crabada is a fun and exciting P2E NFT game where hermit crabs battle, mine, loot, breed and more. With a strong user base and demand for the game, Crabada has launched its own subnet in April - the Swimmer Network.
For further information please visit https://www.crabada.com/.
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/20220530005052/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Announces Key New Hires and Acquires New Crypto Gaming Assets
TORONTO, May 30, 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, is pleased to share that its subsidiary, Hulk Labs, has made several strategic hires and also acquired new gaming assets.
Hulk Labs has added James Hewitt, a P2E gaming expert and Alice Huang, Head of Operations, to the team.
Hulk Labs brought onboard a P2E gaming expert, James Hewitt, who has been conducting deep analysis and building in-depth calculators for the most interesting play-to-earn games for the past year. These tools will be used to advise game developers to improve their own economic models, and by investors (including Hulk Labs itself) to assess which games and strategies can provide the highest earnings potential. Hulk is in the process of integrating these calculators onto its own site at https://hulklabs.com - and will be available to the public in June 2022.
Alice Huang also joined Hulk Labs and Tokens.com as the Head of Operations. Alice is responsible for several initiatives at Hulk including scaling up the base of assets and managing relationships with new and existing games in the Hulk network. Alice has over 15 years of experience in operations, marketing and strategic partnership. Alice is also a published author in Web3.
Hulk Labs has also acquired play-to-earn crypto gaming assets in Crabada.
Crabada is an engaging play-to-earn (P2E) game where players can mine, loot, breed and battle. According to CoinGecko on April 26, 2022, "Crabada had more than 12,000 active wallets, making it the 24th most popular crypto game."
Crabada continues to gain traction with investors and players, with the game’s social media following on a steady uptrend - and a growing reputation as a fun game to play. Being able to make real money feels like a bonus to many players.
Crabada is also the most popular game built on the Avalanche blockchain, generating 64% of transactions on Avalanche at its peak.
Hulk Labs identifies and invests in games at pre-launch. We also provide guidance in tokenomics, marketing and gameplay for early stage P2E games to ensure the success of these projects.
"The Hulk Labs division was created to find exciting, new, and emerging projects with potential for outsized growth in the play-to-earn space. Despite the outback in the crypto market, we believe play-to-earn gaming is the future of online gaming and we want to be positioned to capitalize by attracting the best talent in the industry to our business," commented Andrew Kiguel, CEO of Tokens.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. 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.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
Crabada
Crabada is a fun and exciting P2E NFT game where hermit crabs battle, mine, loot, breed and more. With a strong user base and demand for the game, Crabada has launched its own subnet in April - the Swimmer Network.
For further information please visit https://www.crabada.com/.
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/20220530005052/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
Frank lowered the outstanding shares just like he said he was going to do , also VNTH is pink current, ready to explode. 95% buys today
NEWS -- FuelPositive Attendance at H.C. Wainwright Global Investment Conference
TORONTO, May 26, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”) addressed the attendees of the H.C. Wainwright Global Investment Conference held in Miami on May 25, 2022. Chief Operating Officer Nelson Leite provided a corporate update to conference attendees, and met with a series of registered investors. FuelPositive’s containerized green ammonia production system was the main focus of the presentation.
“We like these conferences because they give us an opportunity to showcase our technology and learn from investors about what matters to them. Our timing to market is the critical factor right now. We continue to be on track to have our first demonstration system fully validated and ready to go by late summer, 2022. By ‘fully validated’, we mean will have validated the purity of the green ammonia produced by the system, as well as the energy consumption, and the rate of production,” said Leite.
The Company has a specific program for validating its technology. Every validation is performed following a standard gage repeatability and reproducibility (gage R&R) process, involving three different tests performed by three different sources. The sources are FuelPositive, an institution such as a university, and a private professional accredited lab. “This process is what our investors and customers expect, so they know they can trust any claims we make,” added Leite.
FuelPositive will also be validating the operating costs it first projected in November 2021, and setting its price for its first customers, who will be farmers. They will use the FuelPositive systems to produce the green ammonia on their farms, using it as fertilizer for their crops and ultimately as fuel to power farm equipment. “It’s safe to say that our price will save farmers dollars and our systems will give them control over supply. We’ve known all along that our green ammonia must be priced lower than grey ammonia, which has become unaffordable for many farmers,” said Leite. To view the November 18, 2021 news release on the initial costing model, follow this link: https://fuelpositive.com/november-2021-corporate-update/
The FuelPositive address to the full conference was recorded on video and will be available soon.
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable “cradle to cradle” clean technology solutions, including a 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 green ammonia production system takes air, water and sustainable electricity and synthesizes it into 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 being considered as 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-user energy and supply security.
Already proven in the lab, FuelPositive is building three full-sized systems to be rolled out in demonstration pilot projects in 2022.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://mailbox1@fuelpositive.com
https://www.fuelpositive.com
Jennifer Spencer
Director, Communications
mailto://jennifer@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 -- Nanomix Granted CE Mark for eLab S1 Assay Panel for Whole Blood Samples
EMERYVILLE, Calif., May 26, 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 received European CE mark designation for its eLab S1 assay panel for use with a lithium heparinized whole blood sample. The eLab S1 is currently marketed and CE marked for use with a plasma sample. The new authorization for a whole blood sample provides even faster results than the Company’s earlier plasma-based panel by eliminating the step of first centrifuging blood to produce a plasma sample.
Key Advantages:
A moderator must have made my post visible again after you hit the wrong button. Thanks for the heads up!
NEWS -- US FDA IDE Process Updates
May 24, 2022 | US FDA Meeting 05.20.22 Summary
The Vivos team felt that our meeting with the US FDA on 5/20/22 was a significant positive turning point in the FDA review process. We proposed an additional short-term animal test to prove beyond any doubt that RadioGel™ can deliver a precise dose of therapeutic radiation and does not migrate from the tumor site. We now have a clear path forward with the review team toward obtaining the IDE needed for the first in human clinical trials.
Eight of the eleven FDA staff that reviewed our original IDE submission were new and not familiar with RadioGel™. They resurfaced legacy questions on dosimetry and the potential for migration which we have repeatedly addressed, but we’ve realized that another animal test is the most efficient means to answer those questions once and for all. We agreed to provide the detailed test plan in another submission and the agency agreed to expedite the schedule for their review. This costs time but helps ensure that they will accept the results.
Since we anticipated this outcome, we have been in detailed discussions with Johns-Hopkins University to perform the animal testing. During the meeting we presented a detailed outline of the proposed testing to obtain interim feedback. The FDA agreed with our outline and provided initial feedback on what they expect to see in the detailed test plan.
The test is straight forward. We will induce VX-2 tumors in rabbits and then measure the activity over time using PET/CT to show, once again, that the Y-90 stays at the injection site. We will then euthanize the rabbits and quantitatively measure the remaining activity in the tumor using very sensitive counters and compare it to the starting activity corrected for decay.
I closed the meeting with a summary as follows:
RadioGel™ will be a leader in Precision Radionuclide Therapy (PRnT). We have the highest Therapeutic Index of any device that the FDA has reviewed. This allows us to administer very high therapeutic doses with insignificant collateral damage to healthy tissue. We can treat lymph nodes with small amounts of Y-90 and achieve doses of 300 Gy or more.
RadioGel™ is intrinsically safe. Even if a significant amount of it activity migrated, which we know does not happen, the risk to the patient would be very low. We pointed out that the FDA has approved other brachytherapy products with much higher activity that is not fully contained. One of the side effects listed on the product label is occasional death.
Finally, we believe that RadioGel™ should have a broad indication for use as a device that allows administering precision radionuclides to any tumor. It is our intent to demonstrate the safety and effectiveness of RadioGel ™ in thyroid cancer therapy and then follow up with additional data to expand the indications for use to other tumor types and anatomic locations.
Michael K. Korenko, Sc.D. – President & CEO
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
NEWS -- Navidea Biopharmaceuticals Announces Acceptance of Abstract for Presentation at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting
DUBLIN, Ohio, May 24, 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 acceptance of its abstract titled, “TAM Targeted Imaging Agents Binding CD206 and Selective Blocking of Off Target Liver Localization” for presentation at this year’s Society of Nuclear Medicine and Molecular Imaging (“SNMMI”) Annual Meeting. This work was performed as part of an ongoing research collaboration with the University of Alabama at Birmingham (“UAB”), in the laboratory of Dr. Suzanne Lapi, Professor and Vice Chair of Research in the UAB Department of Radiology. The poster will be presented by Dr. Jennifer Bartels of UAB.
This year’s annual SNMMI meeting will be held June 11-14 in Vancouver, British Columbia, Canada. The presentation will take place Saturday, June 11, from 6 pm – 8 pm PDT (abstract ID 197; program ID 2862). The abstract will be accessible on the SNMMI’s Annual Meeting website prior to the meeting (https://am.snmmi.org/iMIS/SNMMI-AM).
The objectives of this preclinical study were to evaluate tumor localization of two new CD206 targeted mannosylated dextran (Navidea’s Manocept platform) imaging agents as well as an approach to reduce uptake of these imaging agents by the liver. The new imaging agents were labeled with gallium-68 (“68Ga”) to enable positron emission tomography (“PET”) imaging. The ultimate goals are to develop next generation Manocept imaging agents that offer improved on-target localization and reduced off-target localization. CD206 is a receptor expressed primarily on activated macrophages, including tumor associated macrophages (“TAMs”), as well as the Kupffer cells of the liver. TAM-targeted Manocept imaging enables imaging of tumors. The information gained from these experiments also suggests strategies to improve targeted delivery of therapeutic payloads to TAMs and other clinically significant targets, while simultaneously reducing off-target liver toxicity.
The experiments described in the poster evaluated the biodistribution in mice with and without tumors of the new 68Ga-labeled Manocept imaging agents that differed in their molecular weights. Also evaluated were the effects on their biodistributions of prior administration of unlabeled constructs or a construct designed to specifically block off-target liver localization. Results showed that the amount of the two imaging agents that localized to tumors differed significantly. Also, pretreatment with the construct designed to selectively block liver localization did significantly reduced liver localization of the 68Ga-labeled imaging agents without reducing their localizations to tumors.
Dr. Suzanne Lapi said, “My research group and I are pleased to present this collaborative work with Navidea at SNMMI and to continue to further advance this project with possible far reaching medical imaging and commercial potentials.”
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted by the opportunity to present these results at this internationally recognized meeting.” Dr. Rosol continued, “This is another example in a line of research collaborations we have had with the highest level of researchers at top tier institutions that is resulting in work advancing our platform technology. These new technologies suggest exciting new applications in medical imaging and possibly also new therapeutic strategies.”
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.
About UAB
Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with over $600 million in research awards annually, as well as Alabama’s largest single employer, with some 26,000 employees, and has an annual economic impact exceeding $7.15 billion on the state. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at https://www.uab.edu.
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 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. 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/20220524005401/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Nanomix Announces Upgrade to OTCQB® Venture Market
EMERYVILLE, Calif., May 23, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, is pleased to announce that it has upgraded to the OTCQB® Venture Market (“OTCQB“), and will continue to trade under the symbol NNMX. Investors can find current financial disclosure and Real-Time Level 2 quotes for the Company on https://www.otcmarkets.com.
“Upgrading to the OTCQB is a timely and important milestone for Nanomix, as we continue to commercialize our Nanomix eLab® system, a mobile point-of-care diagnostic testing platform. Joining the OTCQB elevates Nanomix's profile within the investment community, which we expect will help improve liquidity and broaden our shareholder base.”
The OTCQB, operated by OTC Markets Group Inc., offers investors transparent trading in entrepreneurial and development stage United States’ and international companies. The OTCQB is recognized by the United States Securities and Exchange Commission as an established public market providing public information for analysis and value of securities. Companies must be current in their financial reporting and must undergo an annual verification and management certification process, including meeting a minimum bid price and other financial conditions.
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 as well as the rapid identification of current and prior SARS-CoV-2 infection. 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, 2020, 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 -- Navidea Biopharmaceuticals Announces Acceptance of Abstract for Presentation at the Tumor Myeloid-Directed Therapies Summit Annual Meeting
DUBLIN, Ohio, May 23, 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 acceptance of its abstract titled, "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" for presentation of a poster at this year’s Tumor Myeloid-Directed Therapies Summit.
The 2nd annual Tumor Myeloid-Directed Therapies Summit meeting will be held June 14-16, 2022 in Boston, MA. The presentation will take place Tuesday, June 14. Meeting information can be found on the conference website (https://tumor-myeloid-therapeutics.com).
The poster will present information related to the synthesis of two novel bisphosphonate drugs that have been attached to Navidea’s CD206-targeted drug delivery platform molecule, Manocept. These constructs use a novel degradable linker to release the therapy only once they have been internalized into a CD206-expressing cell, such as a tumor associated macrophage. The new therapeutic constructs were evaluated in human macrophage cell culture assays to compare the ability of the new constructs with unbound free therapy to shift the phenotype of macrophages toward a proinflammatory gene expression pattern. The new drug delivery constructs successfully shifted the phenotypes of human macrophages towards a proinflammatory state and compared favorably to the unbound free therapy. The new drug constructs also induced a highly significant reduction in macrophage expression of signal regulatory protein alpha ("SIRPa"), the receptor for the "don’t eat me" signal that, when activated, suppresses the ability of macrophages to attack and phagocytize disease associated cells such as cancer cells. The ability to induce this type of phenotypic change in macrophages could have far-reaching applications in cancer immunotherapy.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "These new therapeutic constructs demonstrate the power of our adaptable platform technology to deliver a wide array of small molecule payloads in a targeted fashion to macrophages involved in the propagation of a variety of severe illnesses including cancer."
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 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. 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/20220523005345/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Nanomix Receives CE Mark for its eLab COVID-19 Rapid Point-of-Care Antigen Panel
EMERYVILLE, Calif, May 20, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCBB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has received the CE mark for its eLab COVID-19 rapid antigen test. The COVID-19 antigen test cartridge is used with the Nanomix eLab® Analyzer to provide qualitative results in 15 minutes from an anterior nasal swab.
“Receiving the CE mark for our COVID-19 rapid antigen test is a key milestone which further validates our rapid and accurate point-of-care (POC) testing technology,” stated John Hardesky, Chief Commercial Officer of Nanomix. “This assay complements our S1 Critical Infection Panel which provides valuable insight to clinicians as they diagnose and monitor severe, co-infections including those of COVID-19 patients.”
“Development of our COVID-19 rapid antigen test is a testament to the hard work of our R&D team and the quality of our technology,” stated David Ludvigson, President and Chief Executive Officer of Nanomix. “The Nanomix eLab® is a comprehensive diagnostic platform that has enormous potential in time-sensitive diagnostic applications.”
The Nanomix COVID-19 rapid antigen test provides qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal (anterior nares) swabs. Nasal swab samples are collected using a provided swab and sample collection tube, and then transferred to the single-use, microfluidic cartridge. The cartridge is run on the Nanomix eLab® Analyzer with results displayed in 15 minutes and the ability to print or send results electronically via Bluetooth. Additionally, the eLab system can publish Nanomix eLab® COVID-19 rapid antigen test results output as a QR code for privacy.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00060.
About Nanomix Corporation
Nanomix 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 as well as the rapid identification of current and prior SARS-CoV-2 infection. 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, 2020, 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 -- CytoSorbents to Present at Two Upcoming Investor Conferences
MONMOUTH JUNCTION, N.J., May 19, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces management will present at two upcoming in–person investor conferences.
On Monday, May 23, 2022, Dr. Phillip Chan, CytoSorbents' Chief Executive Officer, will present at the UBS Global Healthcare Conference 2022 at 9:15 a.m. Eastern time. A live audio webcast will be accessible via the following Link. Company management will also meet with investors during the conference.
Kathleen Bloch, Chief Financial Officer of CytoSorbents, will also present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 4:00 p.m. Eastern time, with a live video webcast accessible via the following Link. Management will also hold investor meetings that day.
An archived recording of CytoSorbents' presentations at both investor conferences will be available under the Investor Relations portion of the Company's website at Events & Presentations - Cytosorbents, and will be available for 90 days.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Please Click to Follow Us on Facebook and Twitter
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- Plus Therapeutics to Present Virtually at the 2022 HC Wainwright Global Investment Conference
AUSTIN, Texas, May 18, 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 virtually at the 2022 H.C. Wainwright Global Investment Conference being held May 23-26, 2022.
The Company’s presentation will be available on-demand May 23-26, 2022, and available under the For Investors tab of the Plus website at https://www.plustherapeutics.com. Investors interested in arranging a virtual 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 on the Plus website 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-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; 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; 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 -- International Stem Cell Corporation Announces Strong Financial Results for the Quarter Ended March 31, 2022
https://www.accesswire.com/701689/International-Stem-Cell-Corporation-Announces-Strong-Financial-Results-for-the-Quarter-Ended-March-31-2022
NEWS -- NightHawk Biosciences Provides First Quarter 2022 Business Update
DURHAM, N.C., May 16, 2022 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the first quarter ended March 31, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are extremely proud of the progress we have made this quarter to transition NightHawk into a fully-integrated biopharmaceutical company. On the business front, this month we announced the name change to NightHawk Biosciences to better reflect our evolution towards a fully integrated ecosystem that enables more rapid delivery of medical innovations with increased quality and efficiency. The NightHawk ecosystem includes an expanded development pipeline and enhanced manufacturing capabilities around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services.”
“Moreover, we recently closed the strategic acquisition of Elusys Therapeutics (Elusys), which significantly expands our foothold in the biodefense space. The addition of Elusys’ ANTHIM®, a treatment for inhalation anthrax, complements our infectious disease product portfolio, which includes our RapidVax® platform, which is designed to target emerging biological threats. Shortly after the completion of the Elusys acquisition, we finalized our first international contract with the Canadian government to deliver ANTHIM® to their national stockpile. We are now pursuing additional opportunities to expand ANTHIM® distribution abroad.”
“At the same time, we continue to expand our biomanufacturing and bioanalytic capabilities. We recently unveiled plans for a new 500,000 square foot commercial/biodefense biomanufacturing facility in Manhattan, Kansas. In addition to servicing our own product pipeline, we plan to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to support other biopharma companies. Moreover, we remain on track for the grand opening of our San Antonio facility in Q2/22.”
Mr. Wolf added, “The NightHawk ecosystem is truly unique among small biopharmaceutical companies. We look forward to providing further updates on our progress later this year.”
First Quarter 2022 Financial Results
NEWS -- NightHawk Biosciences Provides First Quarter 2022 Business Update
DURHAM, N.C., May 16, 2022 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the first quarter ended March 31, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are extremely proud of the progress we have made this quarter to transition NightHawk into a fully-integrated biopharmaceutical company. On the business front, this month we announced the name change to NightHawk Biosciences to better reflect our evolution towards a fully integrated ecosystem that enables more rapid delivery of medical innovations with increased quality and efficiency. The NightHawk ecosystem includes an expanded development pipeline and enhanced manufacturing capabilities around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services.”
“Moreover, we recently closed the strategic acquisition of Elusys Therapeutics (Elusys), which significantly expands our foothold in the biodefense space. The addition of Elusys’ ANTHIM®, a treatment for inhalation anthrax, complements our infectious disease product portfolio, which includes our RapidVax® platform, which is designed to target emerging biological threats. Shortly after the completion of the Elusys acquisition, we finalized our first international contract with the Canadian government to deliver ANTHIM® to their national stockpile. We are now pursuing additional opportunities to expand ANTHIM® distribution abroad.”
“At the same time, we continue to expand our biomanufacturing and bioanalytic capabilities. We recently unveiled plans for a new 500,000 square foot commercial/biodefense biomanufacturing facility in Manhattan, Kansas. In addition to servicing our own product pipeline, we plan to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to support other biopharma companies. Moreover, we remain on track for the grand opening of our San Antonio facility in Q2/22.”
Mr. Wolf added, “The NightHawk ecosystem is truly unique among small biopharmaceutical companies. We look forward to providing further updates on our progress later this year.”
First Quarter 2022 Financial Results
NEWS -- Tokens.com Announces Q1 2022 Financial Results
TORONTO, May 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 businesses linked to the Metaverse and NFT’s, is pleased to announce its financial results for the three months ending March 31, 2022 ("Q1 2022"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q1 2022 HIGHLIGHTS:
NEWS -- Tokens.com Announces Q1 2022 Financial Results
TORONTO, May 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 businesses linked to the Metaverse and NFT’s, is pleased to announce its financial results for the three months ending March 31, 2022 ("Q1 2022"). All dollar figures are in United States dollars ("USD"), unless otherwise stated.
Q1 2022 HIGHLIGHTS:
Lineage Cell Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
NEWS -- PVCT Quarterly Report (10-Q)
May 12, 2022 - 01:49PM
https://ih.advfn.com/stock-market/USOTC/provectus-biopharmaceuti-qb-PVCT/stock-news/88095039/quarterly-report-10-q
NEWS -- Vivos Inc. Provides Intellectual Property Protection Update
Richland WA, May 12, 2022 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to report that it expanded its intellectual property protection on several fronts.
Our patent team filed our particle patent in more than ten patent offices that collectively cover 63 countries throughout the world. This year we also filed a provisional patent number 63-299,930 giving us broader protection on recent and projected developments on both our hydrogel and our particle components. This week we filed a continuation-in-part applications number 1774054 in the USA to expand the claims on our particle patent.
We are near completion on additional development work and intend to file expanded particle claims internationally using the Patent Cooperation Treaty, PCT, process. Additionally, building on the substantial refinements to our hydrogel during the past two years, we also plan to file a new utility patent to protect these proprietary developments. We anticipate the filings will be completed during the third quarter.
In closing Dr. Korenko stated, “We are continually striving to enhance and grow our Intellectual property portfolio to build value to our stakeholders and to strengthen our position as an emerging leader in precision radionuclide therapy.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The IsoPet® Solutions division 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 -- Navidea Biopharmaceuticals Reports First Quarter 2022 Financial Results
Conference Call to be held Thursday, May 12, 2022 at 5:00 pm (EDT)
DUBLIN, Ohio, May 12, 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 its financial results for the first quarter for the period ended March 31, 2022.
First Quarter 2022 Highlights and Subsequent Events
NEWS -- Tokens.com to Announce Its Audited Financial Statements for Q1, 2022 on May 16th, 2022
TORONTO, May 11, 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, is pleased to share that it will announce its financial results for the three months ended March 31, 2022 ("Q1 2022") on May 16th.
An investor call hosted by CEO Andrew Kiguel has been scheduled to discuss the Company’s Q1 2022 financial results starting at 4:00 pm ET on Monday, May 16th, 2022.
Date: May 16th, 2022
Time: 4:00 p.m. ET
Dial-In: 866-455-3403
PIN: 16246076#
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/20220511005171/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 to Announce Its Audited Financial Statements for Q1, 2022 on May 16th, 2022
TORONTO, May 11, 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, is pleased to share that it will announce its financial results for the three months ended March 31, 2022 ("Q1 2022") on May 16th.
An investor call hosted by CEO Andrew Kiguel has been scheduled to discuss the Company’s Q1 2022 financial results starting at 4:00 pm ET on Monday, May 16th, 2022.
Date: May 16th, 2022
Time: 4:00 p.m. ET
Dial-In: 866-455-3403
PIN: 16246076#
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/20220511005171/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 -- Oncolytics Biotech® to Participate in a Fireside Chat at the 2022 RBC Capital Markets Global Healthcare Conference
SAN DIEGO, Calif. and CALGARY, AB, May 10, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, President and Chief Executive Officer, will participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference, which is taking place May 17-18, 2022 at the InterContinental New York Barclay in New York, NY. Additional details on the fireside chat can be found below.
Date: Wednesday, May 18, 2022
Time: 11:00 a.m. ET
Location: InterContinental New York Barclay Morgan Suite, Mezzanine Level
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, contact your RBC representative or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived until August 15, 2022.
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; 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-to-participate-in-a-fireside-chat-at-the-2022-rbc-capital-markets-global-healthcare-conference-301543480.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/May2022/10/c6727.html
NEWS -- NightHawk Biosciences to Present at the 4th Annual Treg Directed Therapies Summit on PTX-35
NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Matthew Seavey, Ph.D., MBA, NightHawk’s Vice President of Research will be presenting data on PTX-35, and serving on an expert panel discussing modes of Treg activation, at the 4th Annual Treg Directed Therapies Summit (https://treg-directed-therapies.com/) being held on May 17-19th in Boston.
PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be utilized to expand regulatory T-cell subsets for auto/inflammatory indications. PTX-35 is the Company's first antibody-based product and is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.
Presentation Date/Time: Day-1, Wednesday, May 18th at 4:30 PM ET
Presentation Title: Agonizing Over Treg Expansion to Treat Human Disease: An Update on Our TNFRSF25-Agonist, PTX-35
Expert Panel Date/Time: Day-2, Thursday, May 19th at 11:30 AM ET
Expert Panel Title: Optimizing Routes of Administration & Delivery Mechanisms to Induce Timely Treg Specific Activation
Discussion Highlights:
NEWS -- NightHawk Biosciences to Present at the 4th Annual Treg Directed Therapies Summit on PTX-35
NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Matthew Seavey, Ph.D., MBA, NightHawk’s Vice President of Research will be presenting data on PTX-35, and serving on an expert panel discussing modes of Treg activation, at the 4th Annual Treg Directed Therapies Summit (https://treg-directed-therapies.com/) being held on May 17-19th in Boston.
PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be utilized to expand regulatory T-cell subsets for auto/inflammatory indications. PTX-35 is the Company's first antibody-based product and is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.
Presentation Date/Time: Day-1, Wednesday, May 18th at 4:30 PM ET
Presentation Title: Agonizing Over Treg Expansion to Treat Human Disease: An Update on Our TNFRSF25-Agonist, PTX-35
Expert Panel Date/Time: Day-2, Thursday, May 19th at 11:30 AM ET
Expert Panel Title: Optimizing Routes of Administration & Delivery Mechanisms to Induce Timely Treg Specific Activation
Discussion Highlights:
Nighthawk Biosystems on Ihub is still using the old board as Heat Biologics
https://investorshub.advfn.com/Heat-Biologics-Inc-HTBX-29469
NEWS -- Lineage Cell Therapeutics to Report First Quarter 2022 Financial Results and Provide Business Update on May 12, 2022
CARLSBAD, Calif., May 05, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its first quarter 2022 financial and operating results on Thursday, May 12, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, May 12, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 20, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1875641.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220505005147/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Justin Frantz
(mailto://jfrantz@soleburytrout.com )
(617) 221-9100
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Navidea Biopharmaceuticals to Host First Quarter 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Thursday, May 12, 2022 at 5:00 p.m. (EDT)
DUBLIN, Ohio, May 05, 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 it will host a conference call and webcast on Thursday, May 12, 2022 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the first quarter ended March 31, 2022.
Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, 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: First Quarter 2022 Earnings Conference Call and Business Update
Date: Thursday, May 12, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 800-285-6670
International Dial-In: +1 713-481-1320
Conference ID: 512400
Webcast Link: https://www.webcast-eqs.com/navidbioph20220512/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at https://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/.
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/20220505005249/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Oncolytics Biotech® and SOLTI Present New Clinical Biomarker Data Demonstrating Pelareorep's Potential to Improve the Prognosis of Breast Cancer Patients at the ESMO Breast Cancer Meeting
Pelareorep treatment resulted in a favorable Risk of Recurrence Score (ROR-S) in 100% of evaluable patients compared to 55% at baseline in a window-of-opportunity study
Statistically significant increases in markers of tumor cell death and T cell activation observed following treatment with pelareorep-based combinations
SAN DIEGO and CALGARY, AB, May 4, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research today announced new clinical biomarker data demonstrating pelareorep's immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer. The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.
Patients in AWARE-1's first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.
"The latest data from AWARE-1 further demonstrate pelareorep's potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep's ability to attack tumors through multiple mechanisms."
Key data and conclusions from the ESMO Breast Cancer poster include:
NEWS -- Provectus Biopharmaceuticals Announces Notice of Allowance of First U.S. Patent of PH-10 Immuno-Dermatology Agent for Treatment of Inflammatory Dermatoses and Epithelial Diseases
KNOXVILLE, TN, May 03, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 16/204,832, “Combination of local and systemic therapies for enhanced treatment of dermatologic conditions,” covering the use of topical PH-10, a formulation of Provectus’ immunogenic-small molecule and pharmaceutical-grade rose bengal sodium (RBS), in combination with one or more systemic therapies for the treatment of various inflammatory dermatoses, such as psoriasis and atopic dermatitis, and various epithelial diseases. PH-10 is a clinical-stage, multi-indication viable, immuno-dermatology-capable pharmaceutical asset.
This allowed patent application will be the first Provectus patent award in dermatology from the USPTO. The Rockefeller University (TRU) is a co-assignee and James Krueger, MD, PhD of TRU’s Laboratory for Investigative Dermatology is a co-inventor.
Dominic Rodrigues, Vice Chair of Provectus’ Board of Directors, said, “We are grateful to Dr. Krueger and his research team for their key contributions to the innovation of the underlying halogenated xanthene medical science of this allowed patent application, and for their continued assistance in the Company’s prosecution efforts for this and other related Provectus intellectual property.”
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 RBS. 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, virology, microbiology, ophthalmology (clinical-stage), and animal health, 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.
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 Securities and Exchange Commission (SEC), including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
###
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Tokens.com Acquires Crypto Gaming Assets in Arcade Land and BitBrawl
TORONTO, May 03, 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, is pleased to share that its subsidiary, Hulk Labs, has acquired play-to-earn crypto gaming assets in Arcade Land and BitBrawl.
The Hulk Labs team has identified Arcade Land and BitBrawl as being part of the next wave of play-to-earn games and platforms. The team has analyzed hundreds of play-to-earn projects and has identified indicators that determine these games to have the largest potential to attract wide audiences and provide outsized returns.
By identifying and investing in games at pre-launch, Hulk Labs secures an attractive entry point prior to the games’ popularization. Hulk Labs has acquired the marquee gaming assets via a variety of NFT marketplaces.
"The Hulk Labs division was created to find exciting, new, and emerging projects with potential for outsized growth in the play-to-earn space. We believe play-to-earn gaming is the future of online gaming and want to be positioned to capitalize by owning key assets in emerging games," commented Andrew Kiguel, CEO of Tokens.com. "By identifying these games as top tier projects we believe they will provide outsized appreciation and yield potential."
Hulk Labs has acquired a variety of Metaverse land parcels in multiple sizes in Arcade Land, a play-to-earn platform where players can build unique experiences on their parcel and allow other players to visit, hangout and play games. Landowners can build stores, place advertising and sell items on their parcel. In addition, the game’s land parcels hold yield earning potential, which will be determined by parcel size.
Hulk Labs has also acquired avatar NFTs in BitBrawl. BitBrawl has a limited number of NFT avatars, creating scarcity. Players earn BRWL tokens, the game's native token through player vs. player online combat, similar to Super Smash Brothers. Players can use the native coin for purchases in the game’s marketplace or cash out their tokens.
Hulk Labs plans to play BitBrawl via gaming guilds to earn token returns. Similar to staking, Tokens.com primarily invests in assets that will generate a yield.
"Significant NFT Project IP has been created over the last 18 months and we are positioning Hulk Labs to actively participate in this growing segment of the NFT market through projects providing experiences, potential revenue models and utility to the owners of Blue Chip NFT assets," said Joshua Doner, Chief NFT Officer of Tokens.com and Hulk Labs. "These game developers are building experiences for existing large communities of NFT owners, therefore, on the launch of the game, there is a larger total player base. This offers a big opportunity as each NFT community has thousands of NFT owners, each with their own audiences reaching millions through their respective social media followings."
Arcade Land is a Metaverse focused on gaming and the play-to-earn ecosystem. It is a land-based Metaverse with 10,000 unique plots where NFT holders can play games with friends. It is focused on interoperability and has signed dozens of partnerships and integrations with top NFT projects. Holders of Arcade Land NFTs get rewarded via tokens, NFTs, and drops of in-game assets. Investors in the ecosystem include Anti Fund, Infinity Ventures Crypto, and Mechanism Capital.
BitBrawl is an online competitive combat game built on the Solana blockchain. It is a player-vs-player game that enables users to compete against one another to earn BRWL tokens, the game's native currency. BitBrawl sold out of its 10,000 unique Brawler NFTs in 9 minutes and has raised investment capital from top funds including Alameda Research, Shima Capital and GSR.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. 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.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
Arcade Inc.
Arcade Land is an interoperable Multiverse with fast action games for the entire NFT community. The Arcade Metaverse allows Blue Chip NFT owners to have a place to hangout, play games, earn tokens, participate in exclusive drops, earn revenue through advertisements, rent out land, create a store and more.
For further information please visit https://arcade.inc/.
BitBrawl
BitBrawl is a skill based, competitive online PVP game based on the Solana blockchain that lets users play against other NFT projects. BitBrawl generates additional utility and cross-pollinates across over 30+ partnered NFT projects in the BitBrawl game.
BitBrawl has 3 game modes, Casual, Ranked and Tournament; that features 1v1, 2v2 and 3v3 game modes where you can use your other NFT's as "Skins" to earn BRWL Tokens. BitBrawl with Solana Ecosystem partners have a combined audience of over 1.5M people.
For further information please visit https://bitbrawl.io/
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 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/20220503005314/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Acquires Crypto Gaming Assets in Arcade Land and BitBrawl
TORONTO, May 03, 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, is pleased to share that its subsidiary, Hulk Labs, has acquired play-to-earn crypto gaming assets in Arcade Land and BitBrawl.
The Hulk Labs team has identified Arcade Land and BitBrawl as being part of the next wave of play-to-earn games and platforms. The team has analyzed hundreds of play-to-earn projects and has identified indicators that determine these games to have the largest potential to attract wide audiences and provide outsized returns.
By identifying and investing in games at pre-launch, Hulk Labs secures an attractive entry point prior to the games’ popularization. Hulk Labs has acquired the marquee gaming assets via a variety of NFT marketplaces.
"The Hulk Labs division was created to find exciting, new, and emerging projects with potential for outsized growth in the play-to-earn space. We believe play-to-earn gaming is the future of online gaming and want to be positioned to capitalize by owning key assets in emerging games," commented Andrew Kiguel, CEO of Tokens.com. "By identifying these games as top tier projects we believe they will provide outsized appreciation and yield potential."
Hulk Labs has acquired a variety of Metaverse land parcels in multiple sizes in Arcade Land, a play-to-earn platform where players can build unique experiences on their parcel and allow other players to visit, hangout and play games. Landowners can build stores, place advertising and sell items on their parcel. In addition, the game’s land parcels hold yield earning potential, which will be determined by parcel size.
Hulk Labs has also acquired avatar NFTs in BitBrawl. BitBrawl has a limited number of NFT avatars, creating scarcity. Players earn BRWL tokens, the game's native token through player vs. player online combat, similar to Super Smash Brothers. Players can use the native coin for purchases in the game’s marketplace or cash out their tokens.
Hulk Labs plans to play BitBrawl via gaming guilds to earn token returns. Similar to staking, Tokens.com primarily invests in assets that will generate a yield.
"Significant NFT Project IP has been created over the last 18 months and we are positioning Hulk Labs to actively participate in this growing segment of the NFT market through projects providing experiences, potential revenue models and utility to the owners of Blue Chip NFT assets," said Joshua Doner, Chief NFT Officer of Tokens.com and Hulk Labs. "These game developers are building experiences for existing large communities of NFT owners, therefore, on the launch of the game, there is a larger total player base. This offers a big opportunity as each NFT community has thousands of NFT owners, each with their own audiences reaching millions through their respective social media followings."
Arcade Land is a Metaverse focused on gaming and the play-to-earn ecosystem. It is a land-based Metaverse with 10,000 unique plots where NFT holders can play games with friends. It is focused on interoperability and has signed dozens of partnerships and integrations with top NFT projects. Holders of Arcade Land NFTs get rewarded via tokens, NFTs, and drops of in-game assets. Investors in the ecosystem include Anti Fund, Infinity Ventures Crypto, and Mechanism Capital.
BitBrawl is an online competitive combat game built on the Solana blockchain. It is a player-vs-player game that enables users to compete against one another to earn BRWL tokens, the game's native currency. BitBrawl sold out of its 10,000 unique Brawler NFTs in 9 minutes and has raised investment capital from top funds including Alameda Research, Shima Capital and GSR.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. 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.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
Arcade Inc.
Arcade Land is an interoperable Multiverse with fast action games for the entire NFT community. The Arcade Metaverse allows Blue Chip NFT owners to have a place to hangout, play games, earn tokens, participate in exclusive drops, earn revenue through advertisements, rent out land, create a store and more.
For further information please visit https://arcade.inc/.
BitBrawl
BitBrawl is a skill based, competitive online PVP game based on the Solana blockchain that lets users play against other NFT projects. BitBrawl generates additional utility and cross-pollinates across over 30+ partnered NFT projects in the BitBrawl game.
BitBrawl has 3 game modes, Casual, Ranked and Tournament; that features 1v1, 2v2 and 3v3 game modes where you can use your other NFT's as "Skins" to earn BRWL Tokens. BitBrawl with Solana Ecosystem partners have a combined audience of over 1.5M people.
For further information please visit https://bitbrawl.io/
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 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/20220503005314/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration
NEWS -- Heat Biologics Completes Name Change to NightHawk Biosciences; Trading to Commence Under “NHWK” Effective at the Market Open Today
DURHAM, N.C., May 03, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. / NightHawk Biosciences (NYSE American: HTBX; NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that it has completed its name change from Heat Biologics, Inc. to NightHawk Biosciences, Inc. to better reflect the Company’s evolution, including expansion of the therapeutic pipeline, vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities. In connection with the name change, the Company’s ticker will change to “NHWK,” effective today, May 3, 2022. The name and symbol changes do not affect the Company's share structure or the rights of the Company's shareholders, and no further action is required by existing shareholders.
Jeff Wolf, CEO of Nighthawk, commented, “The NightHawk brand better reflects our evolution towards a fully integrated ecosystem, designed to efficiently move drugs from discovery through commercialization. The NightHawk ecosystem includes an expanded development pipeline, new biodefense capabilities and enhanced manufacturing capabilities. As a result, we have organized the Company around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services. NightHawk is laser focused on addressing key industry challenges, including the slow pace and high cost of new drug development through a fully integrated ecosystem of drug discovery, preclinical testing and manufacturing. We look forward to progressing these efforts under the NightHawk banner.”
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 creation and manufacture 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 is 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 progressing the company’s efforts under the NightHawk banner. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to progress the company’s efforts under the NightHawk banner, the ability to complete to successfully integrate the changes being made, whether the combined business of NightHawk and Elusys will be successful, 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 , 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 -- CytoSorbents Awarded Preferred Supplier Agreement with Asklepios, One of the Largest Private Hospital Operators in Germany
MONMOUTH JUNCTION, N.J., May 2, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced that the Company has been awarded a new preferred supplier agreement for CytoSorb® with the Asklepios Group (Asklepios), one of the largest private hospital operators in Germany, following the majority acquisition of RHÖN-KLINIKUM AG in 2020.
CytoSorbents has entered into a 3-year preferred supplier agreement with Asklepios, making CytoSorb available without restrictions to all of the approximate 170 healthcare facilities across 14 states throughout Germany that Asklepios operates. This includes Asklepios Klinik St. Georg in Hamburg, Germany, which pioneered the use of CytoSorb to remove antithrombotic drugs during cardiothoracic surgery, and is well-known for their seminal publication on CytoSorb use for this application during emergency cardiac surgery in patients at high risk of bleeding.
Dr. Christian Steiner, Executive Vice President, Sales and Marketing of CytoSorbents stated, "We are excited to announce this agreement with Asklepios, as we are now their preferred supplier of hemoadsorption technology. With this new agreement, CytoSorbents now has preferred supplier agreements with the three largest hospital chains in Germany, providing an opportunity to further grow our business. These privately owned hospital chains are always seeking value-added therapies that provide both clinical and economic benefit to ensure the highest quality medical care for their patients while supporting profitable operations. I am convinced CytoSorb is helping these hospital chains achieve both objectives."
About Asklepios Group
Asklepios was established in 1985 and is now a leading private operator of hospitals in Germany. Asklepios' business activities have always been aimed at providing future-oriented medicine for patients based on the highest quality standards. Asklepios aspires to shape the future of medicine. One key to this lies also in digitalization. The Asklepios vision of a completely integrated digital healthcare group is summed up with the term "Digital HealthyNear". The Group currently has around 170 healthcare facilities throughout Germany represented in 14 German federal states functioning as a nationwide network for holistic healthcare provision. These include acute care hospitals of all different care levels, university hospitals, specialist hospitals, prevention and aftercare, rehabilitation clinics and medical centers. In the 2021 financial year over 3.5 million patients were treated at the Asklepios Group's facilities. The company has more than 67,000 employees. For more information consult https://www.asklepios.com.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 162,000 cumulative CytoSorb devices have been utilized as of December 31, 2021. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- Oncolytics Biotech® and SOLTI Announce Upcoming Poster Presentation at the European Society for Medical Oncology Breast Cancer Meeting
SAN DIEGO, Calif. and CALGARY, AB, May 2, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research today announced the acceptance of an abstract for a poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting, which is taking place both online and in-person at hub27 – Messe Berlin in Berlin, Germany from May 3-5, 2022.
The accepted abstract (#364) is available on the ESMO Breast Cancer Meeting website. Included in the abstract are new results from cohort 1 and cohort 2 of the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, each of which enrolled ten HR+/HER2- early-stage breast cancer patients. These patients were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Evaluation of these cohorts was the primary focus of AWARE-1 as HR+/HER2- is the breast cancer subtype Oncolytics intends to investigate in a future registrational study.
Results of this exploratory study described in the abstract show pelareorep's potential to induce an inflamed tumor phenotype and its synergy with atezolizumab. They also support pelareorep's immune-based mechanism of action and suggest that the combination of pelareorep and atezolizumab may improve outcomes in breast cancer. Additional details on analyses and results described in the abstract will be provided following the publication of its corresponding poster, in accordance with the ESMO Breast Cancer Meeting's embargo policies.
Details on the abstract and upcoming poster presentation are shown below.
Title: The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients - results from AWARE-1 study
Category: Biomarkers and translational research and precision medicine
Abstract Number: 364
Presentation Date: May 4, 2022
Presentation Time: 12:15 p.m. CET
About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.
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; the timing and anticipated content of poster presentation at the upcoming European Society for Medical Oncology Breast Cancer Meeting; 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
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SOURCE Oncolytics Biotech® Inc.
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss First Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Thursday, May 5, 2022, at 5:00 p.m. ET
SAN DIEGO and CALGARY, AB, April 28, 2022 /PRNewswire/ --Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Thursday, May 5, 2022, at 5:00 p.m. ET to discuss a corporate update and financial results for the first quarter of 2022.
Conference Call & Webcast