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NEWS -- Lineage Announces Launch of Phase 2a Study by Genentech of RG6501 (OpRegen®) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
CARLSBAD, Calif., November 28, 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, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration. The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.
"In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA. These results can be maintained beyond one year following a one-time, approximately 30-minute outpatient procedure," stated Brian M. Culley, Lineage CEO. "We are excited that Roche and Genentech are advancing the OpRegen program in a larger clinical study and will seek not only to optimize and potentially improve its delivery, but also confirm safety and activity of OpRegen in this patient population. We expect the findings from this Phase 2a study will be highly informative and may increase the probability of success in any future larger, comparative trials."
"We are excited for the launch of this Phase 2a study, where one of the key objectives is to optimize the delivery of OpRegen to achieve the best outcomes," stated Seppi Lin, Vice President of OMNI Early Clinical Development at Genentech. "This study will provide key insights for the future development of the OpRegen program. Geographic Atrophy (GA) secondary to AMD is a disease area of high unmet need with no approved therapies, and we are committed to developing effective and innovative medicines for patients with serious eye diseases."
About the Phase 2a Study
The planned Phase 2a clinical study is a multicenter, open-label, single arm study to optimize subretinal surgical delivery and to evaluate the safety and activity of OpRegen in patients with GA secondary to AMD. Approximately 30 and up to 60 patients may be enrolled across multiple sites and will receive OpRegen administered as a single subretinal injection to one eye with impaired vision. Study treatment will consist of a single subretinal injection of OpRegen at a dose of up to approximately 200,000 cells delivered to target areas of GA in the study eye.
The primary objectives of the study are to evaluate (i) the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. A key secondary objective is to evaluate the proportion of patients with qualitative improvement in retinal structure, as determined by SD-OCT imaging within 3 months following surgery.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with GA.
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 and preclinical 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 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, 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 potential 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.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our collaboration and license agreement with Roche and Genentech and the timing of anticipated FDA interactions; the potential of RG6501 (OpRegen) to be a safe, effective and durable, one-time treatment for geographic atrophy secondary to age related macular degeneration; the significance of this Phase 2a study, including the potential that it will be informative or increase the potential of success in future larger, comparative trials; and preclinical activities, clinical trials, and clinical data updates related to our programs. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005217/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- AIR MILES Partners with Tokens.com and Metaverse Group to Become First Brand-agnostic Loyalty Program of the Metaverse
New strategic partnership model provides unique opportunity for Canada's original coalition loyalty program to expand its reach and create innovative new solutions for brands and consumers alike in a Web3 universe
TORONTO, November 22, 2022--(BUSINESS WIRE)--The AIR MILES® Reward Program is thrilled to announce that it has partnered with Tokens.com and Metaverse Group to become the first brand-agnostic loyalty program of the Metaverse. This new partnership model will open the doors for AIR MILES to create innovative new channels for partner brands to connect with consumers while extending the scale of the program in the digital world.
The AIR MILES currency is currently issued at more than 300 leading Canadian, global, and online brands and at thousands of retail and service locations across the country. This breadth and scale of its existing partnership models, coupled with the engagement of the millions of Canadians who carry the AIR MILES card in their wallet or have the app on their phone, puts the program in a unique position to leverage this new partnership to extend its reach and impact into the Metaverse.
"As an organization, we are exploring every opportunity to create meaningful connections between the brands we partner with and the customers who engage with AIR MILES every day, including expanding our partnership models in a more open and flexible world. This first-of-its-kind partnership model represents a unique opportunity for us to create exciting new channels for brands to connect with consumers, showcase new reward opportunities for collectors, and grow new communities in a Web3 universe," said Shawn Stewart, President, AIR MILES Reward Program. "Together with Tokens.com and Metaverse Group, we are excited and motivated to tap into the tremendous potential of the Metaverse and bring innovative new solutions to brands and customers everywhere."
"Tokens.com is one of the leaders in the Web3 ecosystem and we are proud to add Canada's leading loyalty rewards company, AIR MILES, to our client roster," said Andrew Kiguel, Co-Founder and CEO of Tokens.com. "Our ability to deliver disruptive Web3 strategies allows us to continue to work with North America's most impactful brands and to move the needle in Web3 adoption across sectors."
"Metaverse Group is excited to partner with such an innovative loyalty program as AIR MILES. There are so many unique opportunities to create value for both Metaverse Group clients and AIR MILES clients. Web3 has endless possibilities for brands to create new and interesting offerings using rewards such as AIR MILES," commented Lorne Sugarman, CEO, Metaverse Group.
Through this new partnership with Tokens.com and Metaverse Group, AIR MILES is now capable of enabling partners to issue Miles within the metaverse, providing an entirely new way for AIR MILES collectors to earn when engaging with brands. AIR MILES will be sharing more details on these new opportunities soon. In the interim, brands looking to be part of this exciting chapter in the AIR MILES story can contact us here.
To learn more about AIR MILES, visit https://airmiles.ca or download the AIR MILES app today.
Brands and businesses interested in developing a Web3 presence can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
About the AIR MILES Reward Program
The AIR MILES Reward Program is Canada's most recognized loyalty program, with millions of active collector accounts. AIR MILES collectors earn Reward Miles at more than 300 leading Canadian, global, and online brands and at thousands of retail and service locations across the country. This activity powers an unmatched data asset that, along with world-class analytics and marketing capabilities, enables clients to accelerate their marketing activities and ROI. The AIR MILES Reward Program gives collectors the flexibility and choice to use Reward Miles on aspirational rewards such as merchandise, travel, events, and attractions, or instantly on everyday essentials, in-store or online, through AIR MILES Cash at participating partner locations. For more information, visit https://www.airmiles.ca.
Forward-looking Statements
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/20221122005638/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 -- AIR MILES Partners with Tokens.com and Metaverse Group to Become First Brand-agnostic Loyalty Program of the Metaverse
New strategic partnership model provides unique opportunity for Canada's original coalition loyalty program to expand its reach and create innovative new solutions for brands and consumers alike in a Web3 universe
TORONTO, November 22, 2022--(BUSINESS WIRE)--The AIR MILES® Reward Program is thrilled to announce that it has partnered with Tokens.com and Metaverse Group to become the first brand-agnostic loyalty program of the Metaverse. This new partnership model will open the doors for AIR MILES to create innovative new channels for partner brands to connect with consumers while extending the scale of the program in the digital world.
The AIR MILES currency is currently issued at more than 300 leading Canadian, global, and online brands and at thousands of retail and service locations across the country. This breadth and scale of its existing partnership models, coupled with the engagement of the millions of Canadians who carry the AIR MILES card in their wallet or have the app on their phone, puts the program in a unique position to leverage this new partnership to extend its reach and impact into the Metaverse.
"As an organization, we are exploring every opportunity to create meaningful connections between the brands we partner with and the customers who engage with AIR MILES every day, including expanding our partnership models in a more open and flexible world. This first-of-its-kind partnership model represents a unique opportunity for us to create exciting new channels for brands to connect with consumers, showcase new reward opportunities for collectors, and grow new communities in a Web3 universe," said Shawn Stewart, President, AIR MILES Reward Program. "Together with Tokens.com and Metaverse Group, we are excited and motivated to tap into the tremendous potential of the Metaverse and bring innovative new solutions to brands and customers everywhere."
"Tokens.com is one of the leaders in the Web3 ecosystem and we are proud to add Canada's leading loyalty rewards company, AIR MILES, to our client roster," said Andrew Kiguel, Co-Founder and CEO of Tokens.com. "Our ability to deliver disruptive Web3 strategies allows us to continue to work with North America's most impactful brands and to move the needle in Web3 adoption across sectors."
"Metaverse Group is excited to partner with such an innovative loyalty program as AIR MILES. There are so many unique opportunities to create value for both Metaverse Group clients and AIR MILES clients. Web3 has endless possibilities for brands to create new and interesting offerings using rewards such as AIR MILES," commented Lorne Sugarman, CEO, Metaverse Group.
Through this new partnership with Tokens.com and Metaverse Group, AIR MILES is now capable of enabling partners to issue Miles within the metaverse, providing an entirely new way for AIR MILES collectors to earn when engaging with brands. AIR MILES will be sharing more details on these new opportunities soon. In the interim, brands looking to be part of this exciting chapter in the AIR MILES story can contact us here.
To learn more about AIR MILES, visit https://airmiles.ca or download the AIR MILES app today.
Brands and businesses interested in developing a Web3 presence can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
About the AIR MILES Reward Program
The AIR MILES Reward Program is Canada's most recognized loyalty program, with millions of active collector accounts. AIR MILES collectors earn Reward Miles at more than 300 leading Canadian, global, and online brands and at thousands of retail and service locations across the country. This activity powers an unmatched data asset that, along with world-class analytics and marketing capabilities, enables clients to accelerate their marketing activities and ROI. The AIR MILES Reward Program gives collectors the flexibility and choice to use Reward Miles on aspirational rewards such as merchandise, travel, events, and attractions, or instantly on everyday essentials, in-store or online, through AIR MILES Cash at participating partner locations. For more information, visit https://www.airmiles.ca.
Forward-looking Statements
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/20221122005638/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® Announces Presentations at the Upcoming San Antonio Breast Cancer Symposium
SAN DIEGO and CALGARY, AB, Nov. 21, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. González Convention Center in San Antonio, Texas from December 6 – 10, 2022.
One poster will feature interim results from a bridging clinical trial being conducted by Oncolytics' partner, Adlai Nortye, to evaluate pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. The second poster, in collaboration with SOLTI-Innovative Cancer Research, will include data from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.
Additional details on the upcoming posters and corresponding abstracts are shown below. Full texts of the abstracts are available on the SABCS website here.
Title: A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced / Metastatic Breast Cancer (REO 026-1)
Program Number: P3-07-04
Session Title: Poster Session 3
Session Date: December 7, 2022
Session Time: 5 p.m. CT
Results published in the SABCS abstract indicate that pelareorep in combination with paclitaxel was safe, well tolerated, and showed anti-tumor activity in Adlai Nortye's single-arm bridging clinical trial in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. As of the abstract's data cut-off date (June 2, 2022), ten patients had been treated in the trial, with four achieving a partial response (two confirmed, two unconfirmed) and five showing stable disease (SD). Eight of the nine patients achieving a partial response (PR) or SD remained on study and continued to receive treatment as of the cut-off date. Updated and additional data from the trial will be presented in the poster corresponding to the abstract in accordance with the SABCS embargo policies.
The bridging trial is designed to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. Results from IND-213 showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel monotherapy. BRACELET-1 remains ongoing, with a readout on overall response rate, progression-free survival, and evolving overall survival data from the randomized phase 2 trial expected in the first half of 2023.
Title: Pelareorep Primes the Tumor for Checkpoint Inhibition Therapy by Activating the Interferon-Gamma Signaling Pathway and Tumor Inflammation Signature in Early Breast Cancer Patients - Results of the AWARE-1 Trial
Program Number: PD4-03
Session Title: Spotlight Poster Discussion 4
Session Date: December 7, 2022
Session Time: 7 a.m. CT
Described in this abstract are the results of gene expression analyses from cohorts 1 and 2 of AWARE-1, a collaborative window-of-opportunity study in patients with early-stage breast cancer that was conducted by Oncolytics Biotech and SOLTI-Innovative Cancer Research. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with the HR+/HER2- breast cancer subtype who were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Results published in the abstract showed that the studied combinations altered tumor microenvironments to induce and enhance anti-tumor immunity. Additional details on the analyses and results described in the abstract will be provided during the SABCS poster presentation in accordance with symposium embargo policies.
About Adlai Nortye
Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with seven drug candidates in development, including (i) Buparlisib (AN2025), which was in a global Phase III clinical trial in combination with paclitaxel for the treatment of patients with recurrent or metastatic HNSCC after anti-PD-1 treatment; (ii) Palupiprant (AN0025), an oral EP4 antagonist which is undergoing Phase Ib trial in combination with Keytruda® in patients with multiple solid tumors; and (iii) AN4005, an oral small molecule PD-L1 inhibitor which was currently in Phase Ia trial. Adlai Nortye is also conducting a Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in the U.S. In addition, Adlai Nortye owns the exclusive rights to Pelareorep (AN1004) in greater China, Singapore, and South Korea, and is conducting a bridging trial in China to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with metastatic HR+/HER2- breast cancer.
Adlai Nortye has assembled an experienced management team, built its proprietary immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: https://www.adlainortye.com.
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 registration studies in metastatic breast cancer and pancreatic 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 the timing and anticipated content of upcoming poster presentations involving pelareorep; Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance towards a registration study in metastatic breast cancer and pancreatic 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-announces-presentations-at-the-upcoming-san-antonio-breast-cancer-symposium-301683418.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Plus Therapeutics Provides Updates on ReSPECT™ Clinical Trials at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology
ReSPECT-GBM clinical trial of rhenium (186Re) obisbemeda in recurrent glioblastoma continues to demonstrate safety and overall survival correlates with radiation dose to tumor
ReSPECT-GBM Phase 2 trial enrollment has begun
Update on ReSPECT-LM clinical trial and first-in-child Phase 1/2a pediatric brain cancer trial for ependymoma and high-grade glioma
AUSTIN, Texas, Nov. 19, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, presented data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM), leptomeningeal metastases (LM), as well as clinical trial plans for pediatric brain cancer at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO).
“Targeted radiotherapy using rhenium (186Re) obisbemeda in patients with GBM and LM has, thus far, been shown to be both feasible and safe across a range of dosages and a variety of delivery parameters. Furthermore, it is unusual to see such a tight correlation between overall survival and absorbed dose at this point of clinical development,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM and ReSPECT-LM clinical trials. “This data strongly supports continued clinical development for several very difficult to treat CNS indications.”
The oral presentation titled, Report of the ReSPECT-GBM Phase 1/2a Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma via Convection Enhanced Delivery (CED) & Planned Phase 2b Trial [RADT-20], included the following key findings:
NEWS -- FuelPositive Announces New Agricultural Greenhouse Gas Mitigation Advisor and On-Farm Nitrate Emissions Mitigation Research Project
Dr. Mario Tenuta of University of Manitoba teams up with the Company’s first demonstration pilot project partners
TORONTO, Nov. 17, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is today announcing the appointment of a new agricultural advisor, Dr. Mario Tenuta as its Agricultural Greenhouse Gas Mitigation Advisor, and sharing the news about a new joint research project aimed at reducing nitrous oxide (N2O) emissions associated with the use of all nitrogen fertilizers, whether organic or synthetic. The project, which is being conducted on the farm of Tracy and Curtis Hiebert, near Sperling, Manitoba, Canada, was initiated during the last week of October 2022. The Hieberts run an 11,000-acre family crop farm on which the first demonstration pilot project of FuelPositive’s onsite, containerized green ammonia (NH3) production system will be carried out. On November 12, 2022, Dr. Tenuta, the Hieberts, and Staff Agronomist Mathieu Proulx, met with FuelPositive for a cold and snowy site visit.
Dr. Mario Tenuta is the Senior Industrial Research Chair in 4R Nutrient Stewardship, and Professor of Applied Soil Ecology at the University of Manitoba. The 4Rs are comprised of right fertilizer, right rate, right time, right place. The 4R Industrial Research Chair Program is advancing research in 4R nitrogen management practices on the Canadian Prairies, to identify solutions to achieving reductions in N2O emissions, as well as improved soil health and crop productivity. The program is a joint project of the Natural Sciences and Engineering Research Council of Canada (NSERC), the Western Grains Research Foundation (WGRF) and Fertilizer Canada.
“We are committed to doing everything we can to reduce greenhouse gas emissions associated with agriculture. Our patent-pending technology eliminates the carbon emissions previously associated with the production of traditional grey ammonia. That’s a gigantic step forward. But we aren’t stopping at that. We are also determined to minimize the nitrous oxide emissions associated with all nitrogen fertilizers. There is no one in Canada better qualified than Dr. Tenuta to lead this research program for us,” said Luna Clifford, Director of Strategic Partnerships and Alliances of FuelPositive. “We suggested the project be conducted on the Hieberts farm since it is near the University of Manitoba. Mario and the Hieberts could not be more in sync with us regarding their shared desire to fight climate change while maximizing soil health and crop yields.”
“We are excited to have the opportunity to partner with FuelPositive and the Hiebert farm in their mission to improve upon a number of key agricultural nitrogen emission reduction methods by researching, developing and promoting responsible and thoughtful farming practices. I'm grateful to the Hieberts and their agronomist Mathieu Proulx for their time and generous offer of a quarter-section of their land for this important research. We aim to showcase how much control, with the right skills and tools, farmers can have over reducing their greenhouse gas emissions, improving their fertilizer usage, and optimizing yields. Obtaining net zero emissions requires forward thinking, along with the right precision application technologies and best practice techniques. When you put them altogether, you can make a real difference in making agricultural production more sustainable,” said Mario Tenuta.
“We are happy to welcome Mario and his team on our farm, and to provide the land, equipment and personnel for this positive research to take place. It’s our first time using NH3 nitrification inhibitors on the farm, and we look forward to participating and benefiting from the research project results throughout 2023 and into the future. This is a great opportunity for us to help the environment while potentially reducing our costs and optimizing our yields,” added Mathieu Proulx, Staff Agronomist at the Hiebert farm.
“It was a pleasure to visit the research project site despite the snow already upon us! We are fascinated with this project, and we couldn't be in better hands thanks to Mario and his team,” added Derek Boudreau, FuelPositive’s Agricultural Implementation Strategic Advisor.
“One of our main goals as a Company committed to a more sustainable food industry is to support farmers in drastically reducing greenhouse gas emissions by using our onsite, containerized green ammonia production system. Mario's close and practical relationships with farmers provide an invaluable asset, assisting us in gaining insight and access. His expertise targeting agricultural greenhouse gas emission reductions will help us care for the environment by helping farmers optimize their use of green ammonia, while mitigating environmental impact,” added Ian Clifford, CEO and Board Chair of FuelPositive.
Eighty per cent of the ammonia produced today globally is used as nitrogen fertilizer. There is a worldwide shortage of ammonia and fertilizer, which is threatening global food security. The FuelPositive onsite, containerized green ammonia production system will allow farmers to make their own ammonia on their farms, where they use it.
About the Project
The goal of the research project is to showcase that by using 4R best practices, used in combination with a nitrification inhibitor, it is possible for farmers to reduce nitrate emissions well beyond 30%, and to better match fertilizer rate to crop needs, while achieving the same or higher yields.
The treatments were anhydrous ammonia at the current recommended and slightly lower rate (85% of recommended), in combination with and without a nitrification inhibitor (also called stabilizer). Dr. Tenuta’s team has found inclusion of a nitrification inhibitor to greatly reduce N2O emissions from soil treated with urea and nitrogen solution fertilizers, but haven’t examined anhydrous ammonia. In this project they will test if reduced nitrogen losses to the environment means farmers can also adjust anhydrous ammonia rates to reduce emissions. Dr. Tenuta’s team will monitor and measure the nitrogen-related emissions (N2O and ammonia) this fall and throughout the next year.
This project is FuelPositive's first on-site emissions reduction research project on the Hiebert farm.
Cost-Offsetting Grants
Over the next four years, farmers in Manitoba can apply for cost-offsetting grants with the Manitoba Association of Watersheds or with the Canola Council of Canada to help cover some of the costs associated with utilizing inhibitors.
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean technology solutions, including an on-site, containerized green ammonia (NH3) production system that eliminates carbon emissions from the production of the green ammonia. By focusing on technologies that are clean, sustainable and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented in the short term.
The FuelPositive onsite, containerized green ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-users energy and supply security while cutting carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional ammonia produced today as fertilizer.
The Company began accepting pre-sale inquiries in August 2022. See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media enquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
NEWS -- Tokens.com Subsidiary Hosts Music Festival in its Music Hub District
TORONTO, November 15, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that its subsidiary, Metaverse Group, hosted a metaverse music festival in Decentraland on its Music Hub property.
This past weekend, Metaverse Group launched its new Music Hub District by hosting its first music festival in conjunction with Decentraland’s Metaverse Music Festival. The Music Hub District streamed performances from 17 different artists across 3 different stages. The artists included an international group of performers including; Emidoina, Wave, Alondra Noctvrna, Two Phase U, Juli Obregron, Kasbeel, Xcelencia, Mateo Dufour, Kion, Hugo Noguchi, Laura Gonzalez, Chindogu, Natt Saves, Iris Saladino, The Perris, Loopthecurator, and Refrakt. This event was put together with Metaverse Group’s partners Beatblox and WaanaMusic.
"Metaverse Group continues to expand its web3 capabilities and to shape metaverse communities," said Andrew Kiguel CEO of Tokens.com and Executive Chair of Metaverse Group. "Entertainment is a key aspect of the metaverse, we were pleased to complete a successful event."
The event attracted over 5000 visitors over the course of the festival. The Music Hub District is home to multiple event spaces that are now available for a variety of entertainment uses including: a main event stage designed for musical performances, a podcast studio, Beatblox Nightclub and a VIP lounge which also features a stage. The property is strategically positioned bordering Decentraland’s Festival Land, driving traffic to the Company’s parcels. This event was designed and created in-house by the Metaverse Group team and is one of many events Metaverse Group intends to hold on this property.
Decentraland’s Metaverse Music Festival featured 15 uniquely designed stages that saw performances from over 180 musical artists from across a wide variety of genres, and new interactive experiences. The global lineup included performances from Björk, Ozzy Osbourne, Dillon Francis, and Soulja Boy to name a few. The events were all free to attend and did not require tickets or special headsets, anyone with a computer and internet access was welcome to join.
Artists, brands, and businesses interested in renting out or creating events in Music Hub District with Metaverse Group should contact mailto://info@metaversegroup.com for more information.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.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/20221115005394/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 Subsidiary Hosts Music Festival in its Music Hub District
TORONTO, November 15, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce that its subsidiary, Metaverse Group, hosted a metaverse music festival in Decentraland on its Music Hub property.
This past weekend, Metaverse Group launched its new Music Hub District by hosting its first music festival in conjunction with Decentraland’s Metaverse Music Festival. The Music Hub District streamed performances from 17 different artists across 3 different stages. The artists included an international group of performers including; Emidoina, Wave, Alondra Noctvrna, Two Phase U, Juli Obregron, Kasbeel, Xcelencia, Mateo Dufour, Kion, Hugo Noguchi, Laura Gonzalez, Chindogu, Natt Saves, Iris Saladino, The Perris, Loopthecurator, and Refrakt. This event was put together with Metaverse Group’s partners Beatblox and WaanaMusic.
"Metaverse Group continues to expand its web3 capabilities and to shape metaverse communities," said Andrew Kiguel CEO of Tokens.com and Executive Chair of Metaverse Group. "Entertainment is a key aspect of the metaverse, we were pleased to complete a successful event."
The event attracted over 5000 visitors over the course of the festival. The Music Hub District is home to multiple event spaces that are now available for a variety of entertainment uses including: a main event stage designed for musical performances, a podcast studio, Beatblox Nightclub and a VIP lounge which also features a stage. The property is strategically positioned bordering Decentraland’s Festival Land, driving traffic to the Company’s parcels. This event was designed and created in-house by the Metaverse Group team and is one of many events Metaverse Group intends to hold on this property.
Decentraland’s Metaverse Music Festival featured 15 uniquely designed stages that saw performances from over 180 musical artists from across a wide variety of genres, and new interactive experiences. The global lineup included performances from Björk, Ozzy Osbourne, Dillon Francis, and Soulja Boy to name a few. The events were all free to attend and did not require tickets or special headsets, anyone with a computer and internet access was welcome to join.
Artists, brands, and businesses interested in renting out or creating events in Music Hub District with Metaverse Group should contact mailto://info@metaversegroup.com for more information.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.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/20221115005394/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 -- Scientific Poster on Innovation Pharmaceuticals Brilacidin to be Presented at 2022 Chemical and Biological Defense Science & Technology Conference
BARDA prioritizing the development of host-targeting and pathogen-agnostic therapeutics for treatment of hospitalized COVID-19 and other serious diseases of the lung
Wakefield, MA - (NewMediaWire) - November 15, 2022 - Innovation Pharmaceuticals (OTCQB: IPIX) ("the Company"), a clinical stage biopharmaceutical company, today announced Brilacidin antiviral and anti-inflammatory data has been accepted for a scientific poster presentation at the 2022 Chemical and Biological Defense Science & Technology Conference (CBD S&T), December 6-9, 2022, based on research conducted at George Mason University's Center for Infectious Disease Research.
The CBD S&T is sponsored by the U.S. government's Defense Threat Reduction Agency's (DTRA) and provides an interactive forum for chemical and biological defense community members from around the world to discuss pressing chem-bio threats. The Brilacidin research has been included as part of the "Broad-Spectrum Therapeutics For Viral Diseases: A Medical Countermeasure Platform For Emerging Threats" session. Data generated in alphaviruses and bunyaviruses showed that Brilacidin possesses both antiviral and anti-inflammatory properties, reinforcing its potential as a broad-spectrum antiviral. The conference abstract can be accessed here.
In related news, results from the Company's Phase 2 study of Brilacidin in hospitalized cases of moderate-to-severe COVID-19 (NCT04784897) are being prepared for publication and will initially be made available as a preprint. Among the study's findings, beneficial treatment effects were observed in subgroups of patients with the highest baseline values for key COVID-19 biomarkers, e.g., SARS-CoV-2 viral load, C-Reactive Protein (CRP), and IL-6. Under compassionate use of Brilacidin in critical cases of COVID-19, investigators observed more stable disease with improvements evident on chest x-rays and in disease biomarkers, such as CRP and ferritin.
Biomedical Advanced Research and Development Authority (BARDA) scientists recently published a paper on lessons learned from COVID-19 trials assessing immunomodulatory drugs in patients with severe forms of the disease, Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). With emerging SARS-CoV-2 variants (and sub-variants) increasingly able to evade monoclonal antibody treatments, as well as COVID-19 vaccines, BARDA has identified an unmet clinical need for developing host-targeting and pathogen-agnostic -- traits Brilacidin is exhibiting -- therapeutics for treatment of hospitalized cases of COVID-19 and other serious diseases of the lungs. Biomarker-based trial design (enrollment restricted to specific subgroups) was highlighted by BARDA as a critical step to increase the likelihood of achieving clinical efficacy of investigational drugs:
"Identifying distinct patient subgroups based on immune profiles across the disease trajectory, regardless of the causative pathogen, may accelerate evaluating host-directed therapeutics in trials of ALI/ARDS and related conditions (e.g., sepsis)."
The Company believes the promising results achieved in Phase 2 testing and based on compassionate use of Brilacidin in COVID-19 are supportive of additional testing in lung diseases, to further characterize Brilacidin's clinical benefit. A future update is planned providing new data and insights on Brilacidin's potential as a novel antifungal agent.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals in the United States and other jurisdictions, including without limitation that compounds and devices may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
mailto://info@ipharminc.com
NEWS -- NightHawk Biosciences Provides Third Quarter 2022 Business Update
DURHAM, N.C., Nov. 14, 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 third quarter ended September 30, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are continuing to progress our biodefense and biomanufacturing efforts within our Elusys and Scorpion subsidiaries. Towards this end, we are making substantial investments in our biomanufacturing capabilities, including our Scorpion San Antonio biologics manufacturing facility, as well as our planned biomanufacturing facility in Manhattan, Kansas.”
Mr. Wolf continued, “Given our evolving focus, we are deprioritizing our oncology programs and discontinuing further development of our clinical-stage oncology assets, including HS-110 and PTX-35, to focus on our biomanufacturing efforts and the discovery, development, and commercialization of innovative medical countermeasures to address unmet and emerging biothreats.”
Mr. Wolf added, “During the quarter, we also recognized $6 million of one-time revenue, related to the sale of ANTHIM® to Canada’s National Emergency Strategic Stockpile, with 80% of these proceeds to be paid out to the former shareholders of Elusys as part of the original purchase consideration. Nevertheless, we believe this is validation of our strategic decision to acquire Elusys earlier this year.”
Third Quarter 2022 Financial Results
NEWS -- Navidea Biopharmaceuticals Reports Third Quarter 2022 Financial Results
Conference Call to be held Tuesday, November 15, 2022 at 5:00 pm (EST)
DUBLIN, Ohio, November 14, 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 three-month and nine-month periods ended September 30, 2022.
View full version Oress Release on businesswire.com: https://www.businesswire.com/news/home/20221114005449/en/
NEWS -- CytoSorbents Announces Pivotal STAR-T Trial Reaches First Milestone With 40 Patients Enrolled
PRINCETON, N.J., Nov. 14, 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 via its proprietary polymer adsorption technology, announced that 40 of the targeted 120 patients have been enrolled in the Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial, achieving the first enrollment milestone and triggering a pre-specified Data and Safety Monitoring Board (DSMB) review. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, to remove the anti-thrombotic agent, ticagrelor (Brilinta®, AstraZeneca), during cardiothoracic surgery.
CytoSorbents' pivotal STAR-T trial using DrugSorb-ATR to remove ticagrelor during cardiac surgery now a third complete
Dr. Michael J. Mack, Director of the Cardiovascular Service line at Baylor Scott & White Health System, Chairman of the Baylor Plano Research Center in Texas and co-Principal Investigator of the STAR-T trial commented: "Reaching our first trial enrollment milestone of 40 patients is a critical first step in the execution of the landmark STAR-T trial. Currently, cardiac surgeons are either forced to delay life-saving heart surgery in patients who are on antithrombotic drugs or proceed to operation when they are at very high risk for bleeding. The DrugSorb-ATR device is a novel approach that could potentially allow these high-risk surgeries to proceed in a safe and timely manner. We have designed two rigorous, pivotal trials to test the efficacy and safety of this novel device that if successful could make it available to all U.S. cardiac surgeons, so they can join their international colleagues who have it available and use it routinely in their everyday practice. We are currently focused on bringing the STAR-T trial across the finish line, so we can then turn our attention to STAR-D. I'd like to thank all of the participating centers and investigators for helping us reach this first crucial enrollment milestone and we remain very excited to welcome our Canadian colleagues who should begin contributing to enrollment very soon."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "We are pleased to have enrolled a third of our STAR-T pivotal study, which now triggers the first safety review by the independent DSMB of the study. We are now working diligently to complete the necessary operational steps including data collection and validation to support the upcoming DSMB safety review which is estimated in approximately 2 months. With our full attention and resources now dedicated to STAR-T and the upcoming addition of Canadian sites, we anticipate the momentum to continue and project that we can achieve the next study milestone of 80 patients enrolled in Spring 2023 that will trigger the next DSMB safety review and the pre-specified interim analysis.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, for this application. The STAR-T trial will be followed by the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) pivotal trial evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking 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 approximately $48 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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CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
mailto://josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
mailto://marcus.schult@die-kommponisten.com
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SOURCE CytoSorbents Corporation
NEWS -- Tokens.com Announces No Exposure to FTX, Alameda Research or FTT Token
TORONTO, November 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 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, today provides an update in light of recent market developments relating to FTX, a digital asset exchange that does not provide any services, or hold any cash or digital assets, for Tokens.com. The Company wishes to confirm that neither Tokens.com nor any of its subsidiaries have any exposure to FTX, its affiliate Alameda Research or its corresponding FTT token.
Tokens.com’s cash balances are held in both US dollars and Canadian Dollars with a nationally chartered banking institution in Canada. All of Tokens.com’s cryptocurrency are listed in a recent press release dated November 1st, 2022. There have been no significant changes to holdings since that date.
As a public company, Tokens.com operates with transparency, providing regular quarterly financial statements and disclosures, which can be found under the Company’s issuer profile on https://www.sedar.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing of resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-looking Statements
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/20221111005546/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Announces No Exposure to FTX, Alameda Research or FTT Token
TORONTO, November 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 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, today provides an update in light of recent market developments relating to FTX, a digital asset exchange that does not provide any services, or hold any cash or digital assets, for Tokens.com. The Company wishes to confirm that neither Tokens.com nor any of its subsidiaries have any exposure to FTX, its affiliate Alameda Research or its corresponding FTT token.
Tokens.com’s cash balances are held in both US dollars and Canadian Dollars with a nationally chartered banking institution in Canada. All of Tokens.com’s cryptocurrency are listed in a recent press release dated November 1st, 2022. There have been no significant changes to holdings since that date.
As a public company, Tokens.com operates with transparency, providing regular quarterly financial statements and disclosures, which can be found under the Company’s issuer profile on https://www.sedar.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing of resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-looking Statements
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/20221111005546/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
Follow link for full Press Release:
https://finance.yahoo.com/news/lineage-cell-therapeutics-reports-third-210500032.html
NEWS -- Oncolytics Biotech® Presents Updated Clinical Data at SITC Annual Meeting Showing a 69% Objective Response Rate and Confirmed Complete Response in GOBLET Study's Pancreatic Cancer Cohort
One complete response (CR) and eight partial responses (PR) achieved in thirteen evaluable patients
69% objective response rate (ORR) is nearly three times greater than the average ORR of ~25% reported in historical control trials
Data support Oncolytics' plan to advance its pancreatic cancer program into a pivotal study
Data to be discussed during a key opinion leader webinar on November 14th at 10 a.m. ET
SAN DIEGO, Calif and CALGARY, AB, Nov. 10, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced updated results from the phase 1/2 GOBLET study's first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort. Patients in this cohort are treated with the combination of pelareorep, Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel. The updated data are featured in a poster presentation at the ongoing Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA.
Objective response rate (ORR) and clinical benefit rate (CBR) in GOBLET's PDAC cohort (n=13) were 69% and 85%, respectively, as of the SITC poster's data cutoff date (October 12, 2022). Additional data and conclusions presented in the poster are summarized below.
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of Small Molecule Cancer Immunotherapy PV-10® Stage III Melanoma Abstract at Melanoma Bridge 2022
KNOXVILLE, TN, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from the Company’s ongoing, multi-cohort, Phase 1b/2 study of the combination therapy of cancer immunotherapy PV-10, an intratumoral formulation of Provectus’ small molecule rose bengal sodium (RBS), and immune checkpoint inhibitor KEYTRUDA® (pembrolizumab) for the treatment of Stage III cutaneous melanoma will be presented at Melanoma Bridge 2022, to be held in Naples, Italy and online from December 1-3, 2022.
The abstract accepted for video oral communication and poster presentation is entitled “Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in stage III cutaneous melanoma.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-modulators called halogenated xanthenes (HXs). Provectus’ lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’ clinical development programs and the preclinical formulations of the Company’s drug discovery programs. Importantly, Provectus’ pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. First, direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’ RBS utilized in the treatment. Secondly, multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such as those trials reported on the clinical trials registry ClinicalTrials.gov. Provectus also believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%.
Provectus’ small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo drug discovery programs in oncology, hematology, wound healing, and animal health; and preclinical in vitro drug discovery programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at https://www.provectusbio.com.
Trademarks
PV-10® is a registered trademark of Provectus, Knoxville, Tennessee, U.S.A.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, New Jersey, U.S.A.
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:
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- FuelPositive Reports on Critical Milestones Update: Team Building, Manufacturing Space, R&D Lab, New Corporate Headquarters and Grant of Options
TORONTO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is issuing a series of updates, news releases and images to share its progress as it enters the final assembly and validation phase of its on-farm, containerized green ammonia production system. Building its team and completing its initial manufacturing facility, R&D lab and new corporate headquarters, are critical milestones, allowing the Company to expedite the commercialization of its products.
“At the same time that we’ve been working on our first demonstration system, we’ve been preparing our Company to handle rapid growth. We knew early on that we needed to assemble a powerful team of people that could scale up quickly, applying their experience and expertise. We’ve done it right. We knew exactly the kind of talent we needed, and we immediately put into place the necessary systems to attract and secure the best people. We’ve been helped because as soon as they hear about it, job candidates recognize the incredible contribution our Company is going to make to sustainability in agriculture and global food security. They want to be a part of it,” said Nelson Leite, FuelPositive Chief Operating Officer and Board Director. “We believe the team we’ve built is the best in the business!”
“We also knew our team would need top quality manufacturing facilities, a highly sophisticated R&D lab, and more office space to get it all done. We said we’d do it all, and we are proud to be able to demonstrate that we have – in what feels like record-breaking time!” added Leite.
Team Hires
A number of significant hires have been completed, strengthening the Waterloo team as it works toward completing the system build and starting first batch manufacturing. Specifically, a Chemical Engineer, Electrical Engineer, Design and Execution Manager, Master Electrician and an Office Manager have joined the team. In addition, a Purchasing Manager, another Chemical Engineer, a High-Pressure Process Piping expert and Sales Representatives have also been hired.
“Nelson and our human resources team have done an outstanding job in attracting and securing the best people to fulfil critical roles across the organization,” commented Ian Clifford, CEO and Board Chair. “On behalf of all of our shareholders, we are deeply grateful for all of this challenging work!”
New Corporate & Sales Headquarters
FuelPositive has opened corporate offices at 420 Weber Street in Waterloo, Ontario which will serve as the corporate and sales headquarters. “Staff are excited to expand into this modern space, situated just blocks from our manufacturing facility and steps away from Laurier University and University of Waterloo with whom we work closely,” said Nelson Leite. “This will provide us with more room to grow as we build our sales and engineering teams.”
Manufacturing and R&D Lab Open & Completed
The initial manufacturing facility and R&D lab at 99 Northland in Waterloo, Ontario have been completed and staff is fully operational. The final validation of the containerized system is being conducted there, and batch manufacturing will be carried out at that site until the Company is ready to move to mass manufacturing.
Announced in August, FuelPositive has identified a site near its Waterloo facilities where it will be custom-building a factory with its land development partner. It will be a large, state-of-the-art facility, up to 140,000 square feet, and will meet the Company’s needs when it switches from batch manufacturing to serial or assembly line manufacturing in late 2023.
Option Grant
The Company also announces that it has granted a total of 34,250,000 incentive stock options (the “Options”) to certain directors, officers, employees and consultants. The Options vest and become exercisable over a 24-month period, with one quarter of the Options vesting after six months and a further one quarter vesting every six months thereafter. The Options are exercisable to acquire an equivalent number of common shares of the Company at a price of CDN $0.13 for a period of 60 months.
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean technology solutions, including an on-site, containerized green ammonia (NH3) production system that eliminates carbon emissions from the production of the green ammonia. By focusing on technologies that are clean, sustainable and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented in the short term.
The FuelPositive onsite, containerized green ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-users energy and supply security while cutting carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional ammonia produced today as fertilizer.
The Company began accepting pre-sale inquiries in August 2022. See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
For Investor enquiries, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://info@fuelpositive.com
https://www.fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
For Media enquiries, please contact:
Oliveah Numan
Sussex Strategy Group
519-770-2991
mailto://onuman@sussex-strategy.com
NEWS -- Nanomix Enters into an Exclusive Veterinary Distribution Agreement for the eLab System with Woodley Equipment Company, Ltd.
SAN LEANDRO, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced that it has entered into an exclusive distribution agreement with Woodley Equipment Company, Ltd. (“Woodley”), a global veterinary distributor. Under the agreement, Woodley will work with Nanomix to develop species specific ranges for the S1 critical infection panel and distribute the eLab system in the veterinary market for regions outside of the United States.
Thomas Schlumpberger, Chief Executive Officer of Nanomix, stated, “I am honored, to not only be working with Mike Wickham and Woodley again, but also for Mike’s equity investment which shows confidence in Nanomix and our technology. Woodley brings a significant product development expertise and structure that allows us to expand our efforts into the veterinary market earlier than planned. Woodley also has a clinical research division where the Nanomix POC solution will broaden their Clinical Research Organization offering. We are thrilled to add Mike’s proven experiences and history of success to our launch and development efforts of the Nanomix eLab® system for the veterinary market and beyond.”
Mike Wickham, Managing Director of Woodley, commented, “Woodley supplies equipment for all aspects of laboratory diagnostics in the veterinary market with a specialization in emergency and critical care devices. We are excited by the possibility to help develop the eLab to be suitable for animals and the impact that this can have worldwide in the healthcare provision for animals. Currently, sepsis in animals has no reliable markers which have a predictive indicator and certainly not at the POC. We are excited that a POC device can be developed to treat animals and Woodley is proud to be involved with Nanomix.”
Sepsis is one of the most important causes of morbidity and mortality in humans and it is also associated with high mortality rates in dogs and cats. Sepsis can develop if an animal is affected by an infection that is left untreated or undertreated. The infection may originate in many different areas contributing to the difficulty in diagnosis, for example, in the ears or even in the skin.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nanomixdx.com.
For the latest insights, follow Nanomix on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- FuelPositive Enters Final Phase of Assembling and Validating First Farm-Ready Demonstration System – Milestone Update: Hydrogen Purity Exceeds Expectations
FuelPositive” or the “Company”) is issuing the first in a series of updates, news releases and images to share its progress as it enters the final phase of assembling and validating its on-farm, containerized green ammonia production system. Its first full-scale demonstration system will be installed and commissioned on an 11,000-acre crop farm in Manitoba, to run as a pilot project through all types of operating conditions. The system will be used to produce green ammonia to be applied as fertilizer, and eventually as fuel for grain drying and internal combustion engines on the farm.
“As we move closer to the full system delivery of our first full-scale, farm-ready demonstration system, we are excited to share some of the key milestones, as we achieve them,” said Ian Clifford, FuelPositive CEO and Board Chair.
For the full release, please visit this link.
NEWS -- Navidea Biopharmaceuticals Announces Details of Presentation at Upcoming Society for Immunotherapy of Cancer Annual Meeting
DUBLIN, Ohio, November 07, 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 details of the results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform. The results will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") to be held at the Boston Convention & Exhibition Center in person and virtually November 8-12, 2022 in Boston, MA. These details were embargoed by SITC until the week of the meeting.
The abstract, "Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes; The Paclitaxel Construct Improves the Efficacy of anti-CTLA4 in CT26 Tumors" (Abstract #1161), will be presented as a poster on November 10, 9 am to 9 pm in the conference center’s poster hall.
In this study, results demonstrate that Navidea’s macrophage-targeting Manocept platform technology, consisting of mannosylated amine dextrans ("MAD") and carrying the therapeutic payloads paclitaxel or a novel bisphosponate, could drive the phenotype of macrophages in vitro towards a proinflammatory type (more CD80 and CD86 expression, less CD206 and CD163 expression). This is important because in tumors there exist tumor-associated macrophages ("TAMs") that are typically of the wound healing, anti-inflammatory type, and these play a key role in paradoxically shielding the tumors from the body’s immune response. Driving the TAM phenotype more towards a proinflammatory state should enable both an immune response against the tumors as well as increase the efficacy of other therapies that can work alongside the body’s immune system against the tumors.
In addition to the in vitro work using both the paclitaxel and bisphosphonate carrying constructs, in vivo studies using the MAD-paclitaxel construct in a mouse tumor model demonstrated that this construct increased the efficacy of an approved checkpoint inhibitor therapy, anti-CTLA4, reducing tumor growth by 76% compared to a saline control. Delivery of paclitaxel and bisphosphonates by this method also reduces off-target exposure and should limit toxicity.
Future studies will examine the effect of the MAD-bisphosphonate therapy with and without anti-CTLA4 therapy in the mouse tumor model. Preclinical toxicity studies will also be conducted en route to an Investigational New Drug ("IND") application.
Abstract title and session information can be found on the SITC Annual Meeting website at: https://www.sitcancer.org/2022/home.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these important preclinical results at this internationally recognized meeting. These results provide support for the hypothesis that our macrophage-targeted constructs can increase the efficacy of already approved therapies to significant effect, helping to rally the body’s immune response against tumors." Dr. Rosol continued, "We continue to develop the Manocept platform, using its potent ability to target macrophages, for the development of new immunotherapies for diseases 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 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/20221107005987/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Oncolytics Biotech® Reports Third Quarter 2022 Financial Results and Recent Operational Highlights
SAN DIEGO and CALGARY, AB, Nov. 7, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the third quarter ended September 30, 2022. All dollar amounts are expressed in Canadian currency unless otherwise noted.
Follow link to view entire Press Release: https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-third-quarter-2022-financial-results-and-recent-operational-highlights-301669590.html
NEWS -- Oncolytics Biotech® Reports Interim Results from Phase 1/2 GOBLET Study Showing a 70% Objective Response Rate in Pancreatic Cancer at the SITC Annual Meeting
70% objective response rate (ORR; n=10) is nearly triple the average ORR of ~25% reported in historical control trials1-4
Data suggest pelareorep synergizes with PD-(L)1 inhibitors and standard-of-care chemotherapy in advanced/metastatic pancreatic ductal adenocarcinoma
Oncolytics plans to present pancreatic cancer data to regulators to determine the most expeditious path to approval
Company management to discuss these results and ongoing efforts to advance pelareorep into registration studies in breast and pancreatic cancer during Q3 earnings call today at 8:30 a.m. ET
Updated data from GOBLET's pancreatic cancer cohort to be presented in a poster at the SITC meeting and discussed during a key opinion leader webinar on November 14th at 10 a.m. ET
SAN DIEGO and CALGARY, AB, Nov. 7, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today reported interim results from the phase 1/2 GOBLET study's first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort in an abstract published as part of the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. The SITC meeting is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022.
As of the abstract's data cutoff date (July 28, 2022), seven of ten evaluable patients in GOBLET's PDAC cohort, which evaluates pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination.
"The ORR reported in the SITC abstract is remarkably nearly triple the average ORR seen in historical control trials of gemcitabine plus nab-paclitaxel, which is only about 25%," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "Further, PD-(L)1 inhibitors only benefit fewer than one percent of pancreatic cancer patients classified as MSI-high. GOBLET's interim results, therefore, strongly suggest that pelareorep's ability to reverse immunosuppressive tumor microenvironments produces synergies when combined with checkpoint inhibition and chemotherapy, leading to vastly improved responses. Given the urgent need for novel therapies in pancreatic cancer, I believe this exciting finding highlights an opportunity for pelareorep to transform the standard of care."
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "GOBLET's interim results represent a crucial clinical milestone, providing robust proof-of-concept in a difficult-to-treat indication. Our next step is to discuss these data with regulatory authorities and potential partners, with the goal of advancing our pancreatic cancer program into a pivotal study. By adding a second near-term registration opportunity alongside our breast cancer program, we have enhanced pelareorep's value proposition and further de-risked our clinical pipeline. I look forward to discussing the strategic implications of our new data during our earnings call today and to hearing expert perspectives on GOBLET's results at our key opinion leader webinar next week."
Updated results from GOBLET's PDAC cohort, which is designed to enroll twelve evaluable patients, will be presented in a poster at the upcoming SITC meeting. The trial's metastatic colorectal and advanced anal cancer cohorts are proceeding as planned, with the cohort in third-line metastatic colorectal cancer now fully enrolled.
Alongside this potential PDAC opportunity, Oncolytics continues to advance pelareorep towards a registration study in metastatic breast cancer. The company's randomized phase 2 trial in HR+/HER2- metastatic breast cancer, BRACELET-1, remains on track for a readout on overall response rate, progression-free survival, and evolving overall survival data in the first half of 2023.
Additional details related to the SITC abstract and upcoming poster, entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study, are shown below.
Abstract Number: 650
Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET
Poster Session Location: Boston Convention and Exhibition Center, Hall C
A copy of the abstract is currently available for viewing in the Journal for ImmunoTherapy of Cancer (JITC) supplement. A copy of the poster will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the meeting.
Earnings Webcast and Conference Call
The Oncolytics management team will discuss the data published in the SITC abstract and the Company's clinical development strategy in pancreatic cancer during its third quarter earnings call taking place today, November 7, 2022 at 8:30 a.m. ET. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.
Key Opinion Leader Webinar
Oncolytics will host a key opinion leader (KOL) webinar on November 14, 2022 at 10 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management team will discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the updated interim GOBLET study results that will be presented at the SITC meeting. A live question and answer session will follow the formal presentations.
To register for the webinar, please click here.
References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);
2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
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 registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action, potential and benefits of pelareorep as a cancer therapeutic; our plan to discuss our GOBLET data with regulatory authorities and potential partners; our goal of advancing its pancreatic cancer program into a pivotal study; Oncolytics' belief that pelareorep's value proposition has been enhanced and that the Company's clinical program has been further de-risked by virtue of the GOBLET data; the timing of release of updated GOBLET and BRACELET-1 results; our plans to advance towards a registration study in metastatic breast cancer and pancreatic 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 -- Nanomix Enters into Multi-Country Distribution Agreement for the eLab System with Mast Group Limited
SAN LEANDRO, Calif., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care (POC) diagnostics, today announced that it has entered into a multi-region distribution agreement with Mast Group Limited (“Mast”), an independent world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing. Mast is headquartered in the United Kingdom and has subsidiary companies in Reinfeld, Germany (Mast Diagnostica GmbH) and Amiens, France (Mast Diagnostic). Mast will market and distribute the Nanomix eLab® system in the United Kingdom, Germany, France, Ireland and South Africa.
Thomas Schlumpberger, Chief Executive Officer of Nanomix, stated, “This new agreement with Mast Group becomes our largest expansion to date within Europe for the Nanomix eLab® system. The Nanomix solution is a unique, breakthrough technology that offers mobile, timely diagnostic capability from a whole blood sample. The eLab system will help expedite sepsis and pneumonia diagnosis leading to more informed treatment decisions, thus improving patient outcomes and hospital clinical collaboration.”
John Hardesky, Chief Commercial Officer of Nanomix, stated, “It has been a pleasure working with The Mast Group to bring this agreement to fruition. Mast has significant experience and presence in this increasingly complex and important area of critical infections, sepsis, and antibiotic stewardship. Their team is experienced and is actively participating in clinical conversations and solutions to improve patient outcomes and impact hospital performance. We are excited to actively align with Mast on an aggressive execution plan to bring our technology to multiple markets throughout Europe.”
Sandy Daun, Sales and Marketing Director of Mast Group, commented, “The Mast Group has always been proud of its commitment and ability to offer innovative diagnostic products that help our customers. We are pleased to begin this long-term, strategic relationship with Nanomix which reinforces that commitment. The platform technology provides the right foundation for assay expansions which will complement the growth areas important to Mast and our customers.”
Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. Furthermore, the S1 Panel Cartridge was developed as an aid in rapidly diagnosing critical infections including sepsis. The panel provides quantitative test results for procalcitonin (PCT), C-reactive protein (CRP) and lactate (LAC) from a single venous whole blood or plasma sample type. The assay runs on the eLab® Analyzer with results available in approximately 12 minutes from sample to answer, versus the current diagnostic solutions which can take hours to provide a test result. The S1 Panel assay has received the CE marking in Europe and has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration.
About Mast Group Ltd.
Mast Group Ltd, is an independent world class manufacturer and supplier of diagnostic products for clinical, industrial, and veterinary testing. Mast manufacturing includes microbiology, molecular biology, as well as infectious disease and autoimmune diagnostics. The Mast product portfolio has been greatly expanded and supplies worldwide to customers including hospital, private clinical, and public health. Mast Group Ltd. offers its specialized product range through its own companies plus a global network of distributors.
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit www.nanomixdx.com.
For the latest insights, follow Nanomix on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- Navidea Biopharmaceuticals to Host Third Quarter 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Tuesday, November 15, 2022 at 5:00 p.m. (EST)
DUBLIN, Ohio, November 04, 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 Tuesday, November 15, 2022 at 5:00 p.m. (EST) to discuss corporate developments and financial results for the third quarter ended September 30, 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: Third Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, November 15, 2022
Time: 5:00 p.m. (EST)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13733801
Webcast Link: https://www.webcast-eqs.com/navidbioph20221115/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/20221104005152/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2022 Financial Results and Provide Business Update on November 10, 2022
CARLSBAD, Calif., November 03, 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 third quarter 2022 financial and operating results on Thursday, November 10, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 10, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 5262180. 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 November 17, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5262180.
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 and preclinical 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 development for the treatment of geographic atrophy secondary to age-related macular degeneration, 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 potential 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/20221103005165/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Provectus Biopharmaceuticals Announces World Health Organization Selection of “Rose Bengal Sodium” as International Nonproprietary Name for Active Pharmaceutical Ingredient
KNOXVILLE, TN, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected “rose bengal sodium” (RBS) for the nonproprietary name of the Company’s active pharmaceutical ingredient (API). Pharmaceutical-grade RBS is the API in Provectus’ current clinical-stage drug product candidates and preclinical formulations.
The RBS name was selected by the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, reached the status of recommended INN after a period of public consultation, and was included in INN Recommended List 88 published with the No. 3 issue of the WHO Drug Information, Volume 36 in October 2022.
The aim of the INN system since inception has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance or API, according to the WHO. The existence of an international nomenclature in the form of INN is important for the accurate identification, prescribing, and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.
Provectus is the first and only entity to have made pharmaceutical-grade RBS at a purity of nearly 100%. This success resulted from:
NEWS -- Plus Therapeutics to Provide Update on ReSPECT™ Clinical Trials at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology
Recurrent glioblastoma and leptomeningeal metastases data have been selected for oral presentations
Pediatric brain cancer plans will be shared via poster session
AUSTIN, Texas, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma, leptomeningeal metastases, as well as clinical trial plans for pediatric brain cancer at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) being held November 16-20, 2022 at the Tampa Convention Center in Tampa Bay, Florida.
Accepted abstracts will be published and made available on November 11, 2022 at https://academic.oup.com/neuro-oncology/supplements.
Copies of the presentations will also be available under the Presentations tab of the Investors section of the Company’s website at the time of the presentations at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Tokens.com Provides Operational and Capital Update
TORONTO, November 01, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to share an update on its operational business segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing of resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
"Since the inception of Tokens.com in 2020, we have built three successful and growing business segments that are all revenue positive and self-sustaining," said Andrew Kiguel, CEO of Tokens.com. "The Company is well capitalized and provides investors with diversified exposure to web3 assets and businesses."
Staking Highlights
Tokens.com currently owns the following tokens used in its staking operations: Ethereum, Solana, Oasis, Polkadot, NFTX, Mana, Ankr and Shiba Inu. Staking is the environmentally friendly equivalent of crypto mining. Stakers use token ownership to validate blocks on the blockchain andare compensated in the form of additional tokens. The tokens owned by the Company are in liquid markets. and from time to time may be liquidated for corporate overhead or rebalancing purposes.
"Staking represents our original business line. The staking process enables our shareholders to earn revenue through the ownership of some of the largest and most liquid crypto assets in the world, which are linked to web3 applications," added Andrew Kiguel, CEO, Tokens.com.
Staking operations are wholly owned and operate within the parent company, Tokens.com. The Company’s token balance grows organically daily via the staking process which compensates the Company with payment in additional tokens. This occurs on a daily basis, all year round. A list of the key tokens owned by the Company is below. Tokens.com owns more aggregate tokens by volume than it ever has before in its history. However, Management notes, the values of these tokens have been and expect to remain volatile. The tokens are selected based on their utility in building web3 infrastructure and potential for appreciation over time.
Tokens.com marks-to-market the value of its tokens at the end of each reporting period. As a result, its quarterly and annual financial statements are subject to these non-cash impacts depending on if the value of the tokens has increased or decreased.
The current market value of the tokens held by the Company is approximately CAD$11.3 million, at current exchange rates and the listed market value of the tokens.
Metaverse Group Highlights
Tokens.com is the majority owner of Metaverse Group, with approximately 58% ownership. Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. It integrates web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that its clients can own ecomm3, engage new audiences, and be first movers.
Currently, Metaverse Group operates 850+ virtual land parcels across 12 metaverses. Of these parcels, it has the most occupancy in the Decentraland metaverse, which is one of the most active web3 metaverses that are currently live. Within Decentraland, Metaverse Group has 179 parcels occupied by tenants. The subsidiary is also in numerous discussions with other potential clients for additional services, such as the creation of NFT loyalty programs, virtual stores, NFT membership programs, and the planning of metaverse-based events.
Currently, Metaverse Group has approximately 85 clients and 8 employees. Metaverse Group continues to see growing demand for its services and has a pipeline of potential clients. Metaverse Group is also building its service offerings with new Augmented Reality and Virtual Reality capabilities. The team and scale of the business are growing at a fast pace.
"We have seen incredible traction with tier one clients at Metaverse Group who choose our team due to our ability to deliver category-leading experiences that leverage our land portfolio and technology," said Lorne Sugarman, CEO of Metaverse Group. "As we scale, we are developing new proprietary technology and leveraging the world’s best immersive digital solutions so that we can continue to be world leaders."
Tokens.com’s management believes that Metaverse Group’s valuation extends beyond its digital land assets, which were last valued in Tokens.com’s quarterly financial statements ending June 30, 2022, at approximately CAD$9.4 million, at current exchange rates. Metaverse Group has successfully leveraged its digital assets through a strong team dedicated to digital land developments, leasing capabilities, and revenue generation.
Hulk Labs Highlights
Tokens.com is the majority owner of Hulk Labs with approximately 94% ownership. Hulk Labs ("Hulk") is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs.
Hulk has a team of 6 people overseeing its operations. Since its launch in early 2022, the Hulk team has grown to manage over 1,000 player wallets and has a waitlist of over 2,000 players, primarily in African markets including South Africa, Tanzania, and the Democratic Republic of Congo (DRC). The team has a target of surpassing 10,000 players in its network by the end of 2023. This growing player network is a key strategic advantage for Hulk Labs in generating revenue and is in high demand by P2E game developers seeking additional users and liquidity for their titles.
In addition, in 2023, Hulk Labs plans to begin beta testing proprietary software that will connect its player network to interested investors, similar to how companies such as Uber Technologies Inc. connect passengers to drivers. Hulk’s player network will significantly benefit from the proprietary software under development within Playte, Hulk’s acquisition completed July 2022.
Hulk’s players have spent the majority of their time on two P2E titles, Crabada and Thetan Arena. These titles have enabled our team to generate double digit (10%+) gross monthly returns on our asset base.
Hulk has currently deployed approximately CAD$540k across several P2E and NFT projects. Many of these investments are in projects such as CryptoPunks and NFTX which provide utility to the broader NFT ecosystem.
"The rapid development of the P2E industry and the revenue and traction Hulk Labs has been able to gain since our launch less than a year ago has us on track to win significant market share in the P2E space," commented Deven Soni, President of Hulk Labs.
In August 2022, Hulk Labs raised approximately CAD$680k of strategic capital at current exchange rates. That transaction was completed at a CAD$10.9 million pre-money valuation which equates to a post-money valuation for Hulk Labs of approximately CAD$11.6 million, at current exchange rates. Since August, the subsidiary has achieved many new milestones and is now revenue positive.
Domain Names
Tokens.com also owns several domain names it believes to have market value. This not only includes the Tokens.com domain, but also tokenstrading.com and tokensart.com. Metaverse Group owns metaversegroup.com. While the value of domain names is not easy to pinpoint and can vary in different sectors and markets, management feels these domains do have a market value, particularly in the crypto and metaverse sectors. Management has received inquiries regarding our desire to sell the Tokens.com domain name, with soft offers in the mid-seven figure range. At this time, Management feels retaining the domain name is its best use, however, reserves the option to reevaluate that decision under different circumstances.
Capitalization
As at the end of the last quarter, Tokens.com and its subsidiaries held CAD$7.8 million in cash, at current exchange rates. In addition, the Company is able to liquidate its digital assets used in the staking operations within a short period of time for additional capital if required. Management at Tokens.com does not believe the current market price for its common shares reflects the inherent value in the Company or the aggregate value of its businesses, digital assets, and cash. As such, on October 27th, Tokens.com announced the launch of a normal course issuer bid program to buy back its shares in the market for cancellation. Tokens.com has 96,926,757 shares issued and outstanding and a public float of 72,377,444.
Tokens.com does not foresee a requirement to raise capital in the near term given its three business segments are revenue positive, its low operating overhead, and its existing cash and token balances.
Our most recent quarterly financial statements, ending June 30th, 2022 and reviewed by the Company’s auditors, had total assets of approximately CAD$31.0 million including a cash balance of approximately CAD$7.8 million, at current exchange rates. This equates to CAD$0.32 per common share in asset values.
Tokens.com’s cash at the last reported quarter ending June 30th, 2022, and its current value of tokens is equal to approximately CAD$19.1 million, or CAD$0.20 per common share at current exchange rates. This value does not include the additional value of the businesses and digital assets contained within Hulk Labs and Metaverse Group described above.
Tokens.com expects to release its audited year-end financial statements for the nine months ended September 30th, in mid-December.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that invests in web3 assets and businesses.
For further information please visit https://hulklabs.com.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds an eight-figure metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-looking Statements
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/20221101005831/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 Provides Operational and Capital Update
TORONTO, November 01, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to share an update on its operational business segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing of resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
"Since the inception of Tokens.com in 2020, we have built three successful and growing business segments that are all revenue positive and self-sustaining," said Andrew Kiguel, CEO of Tokens.com. "The Company is well capitalized and provides investors with diversified exposure to web3 assets and businesses."
Staking Highlights
Tokens.com currently owns the following tokens used in its staking operations: Ethereum, Solana, Oasis, Polkadot, NFTX, Mana, Ankr and Shiba Inu. Staking is the environmentally friendly equivalent of crypto mining. Stakers use token ownership to validate blocks on the blockchain andare compensated in the form of additional tokens. The tokens owned by the Company are in liquid markets. and from time to time may be liquidated for corporate overhead or rebalancing purposes.
"Staking represents our original business line. The staking process enables our shareholders to earn revenue through the ownership of some of the largest and most liquid crypto assets in the world, which are linked to web3 applications," added Andrew Kiguel, CEO, Tokens.com.
Staking operations are wholly owned and operate within the parent company, Tokens.com. The Company’s token balance grows organically daily via the staking process which compensates the Company with payment in additional tokens. This occurs on a daily basis, all year round. A list of the key tokens owned by the Company is below. Tokens.com owns more aggregate tokens by volume than it ever has before in its history. However, Management notes, the values of these tokens have been and expect to remain volatile. The tokens are selected based on their utility in building web3 infrastructure and potential for appreciation over time.
Tokens.com marks-to-market the value of its tokens at the end of each reporting period. As a result, its quarterly and annual financial statements are subject to these non-cash impacts depending on if the value of the tokens has increased or decreased.
The current market value of the tokens held by the Company is approximately CAD$11.3 million, at current exchange rates and the listed market value of the tokens.
Metaverse Group Highlights
Tokens.com is the majority owner of Metaverse Group, with approximately 58% ownership. Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. It integrates web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that its clients can own ecomm3, engage new audiences, and be first movers.
Currently, Metaverse Group operates 850+ virtual land parcels across 12 metaverses. Of these parcels, it has the most occupancy in the Decentraland metaverse, which is one of the most active web3 metaverses that are currently live. Within Decentraland, Metaverse Group has 179 parcels occupied by tenants. The subsidiary is also in numerous discussions with other potential clients for additional services, such as the creation of NFT loyalty programs, virtual stores, NFT membership programs, and the planning of metaverse-based events.
Currently, Metaverse Group has approximately 85 clients and 8 employees. Metaverse Group continues to see growing demand for its services and has a pipeline of potential clients. Metaverse Group is also building its service offerings with new Augmented Reality and Virtual Reality capabilities. The team and scale of the business are growing at a fast pace.
"We have seen incredible traction with tier one clients at Metaverse Group who choose our team due to our ability to deliver category-leading experiences that leverage our land portfolio and technology," said Lorne Sugarman, CEO of Metaverse Group. "As we scale, we are developing new proprietary technology and leveraging the world’s best immersive digital solutions so that we can continue to be world leaders."
Tokens.com’s management believes that Metaverse Group’s valuation extends beyond its digital land assets, which were last valued in Tokens.com’s quarterly financial statements ending June 30, 2022, at approximately CAD$9.4 million, at current exchange rates. Metaverse Group has successfully leveraged its digital assets through a strong team dedicated to digital land developments, leasing capabilities, and revenue generation.
Hulk Labs Highlights
Tokens.com is the majority owner of Hulk Labs with approximately 94% ownership. Hulk Labs ("Hulk") is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs.
Hulk has a team of 6 people overseeing its operations. Since its launch in early 2022, the Hulk team has grown to manage over 1,000 player wallets and has a waitlist of over 2,000 players, primarily in African markets including South Africa, Tanzania, and the Democratic Republic of Congo (DRC). The team has a target of surpassing 10,000 players in its network by the end of 2023. This growing player network is a key strategic advantage for Hulk Labs in generating revenue and is in high demand by P2E game developers seeking additional users and liquidity for their titles.
In addition, in 2023, Hulk Labs plans to begin beta testing proprietary software that will connect its player network to interested investors, similar to how companies such as Uber Technologies Inc. connect passengers to drivers. Hulk’s player network will significantly benefit from the proprietary software under development within Playte, Hulk’s acquisition completed July 2022.
Hulk’s players have spent the majority of their time on two P2E titles, Crabada and Thetan Arena. These titles have enabled our team to generate double digit (10%+) gross monthly returns on our asset base.
Hulk has currently deployed approximately CAD$540k across several P2E and NFT projects. Many of these investments are in projects such as CryptoPunks and NFTX which provide utility to the broader NFT ecosystem.
"The rapid development of the P2E industry and the revenue and traction Hulk Labs has been able to gain since our launch less than a year ago has us on track to win significant market share in the P2E space," commented Deven Soni, President of Hulk Labs.
In August 2022, Hulk Labs raised approximately CAD$680k of strategic capital at current exchange rates. That transaction was completed at a CAD$10.9 million pre-money valuation which equates to a post-money valuation for Hulk Labs of approximately CAD$11.6 million, at current exchange rates. Since August, the subsidiary has achieved many new milestones and is now revenue positive.
Domain Names
Tokens.com also owns several domain names it believes to have market value. This not only includes the Tokens.com domain, but also tokenstrading.com and tokensart.com. Metaverse Group owns metaversegroup.com. While the value of domain names is not easy to pinpoint and can vary in different sectors and markets, management feels these domains do have a market value, particularly in the crypto and metaverse sectors. Management has received inquiries regarding our desire to sell the Tokens.com domain name, with soft offers in the mid-seven figure range. At this time, Management feels retaining the domain name is its best use, however, reserves the option to reevaluate that decision under different circumstances.
Capitalization
As at the end of the last quarter, Tokens.com and its subsidiaries held CAD$7.8 million in cash, at current exchange rates. In addition, the Company is able to liquidate its digital assets used in the staking operations within a short period of time for additional capital if required. Management at Tokens.com does not believe the current market price for its common shares reflects the inherent value in the Company or the aggregate value of its businesses, digital assets, and cash. As such, on October 27th, Tokens.com announced the launch of a normal course issuer bid program to buy back its shares in the market for cancellation. Tokens.com has 96,926,757 shares issued and outstanding and a public float of 72,377,444.
Tokens.com does not foresee a requirement to raise capital in the near term given its three business segments are revenue positive, its low operating overhead, and its existing cash and token balances.
Our most recent quarterly financial statements, ending June 30th, 2022 and reviewed by the Company’s auditors, had total assets of approximately CAD$31.0 million including a cash balance of approximately CAD$7.8 million, at current exchange rates. This equates to CAD$0.32 per common share in asset values.
Tokens.com’s cash at the last reported quarter ending June 30th, 2022, and its current value of tokens is equal to approximately CAD$19.1 million, or CAD$0.20 per common share at current exchange rates. This value does not include the additional value of the businesses and digital assets contained within Hulk Labs and Metaverse Group described above.
Tokens.com expects to release its audited year-end financial statements for the nine months ended September 30th, in mid-December.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through the sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that invests in web3 assets and businesses.
For further information please visit https://hulklabs.com.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services, so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds an eight-figure metaverse real estate portfolio spanning over 10+ metaverses.
Our ownership over 750 parcels of virtual land and relationships with different metaverses and industry players allow us to deliver category leading solutions that have been recognized by CNBC, Forbes, the Economist and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-looking Statements
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/20221101005831/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
I see no tons of selling maybe a new eyeglass prescription is due.
NEWS -- National Institutes of Health Grants Phase I SBIR Award to CytoSorbents to Test Novel Polymers for Cytokine and Endotoxin Removal from Septic Porcine Plasma
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer
PRINCETON, N.J., Oct. 31, 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 via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death.
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis - a deadly global killer
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Gram-negative infections play an important and feared role in sepsis, accounting for approximately 40% of cases of septic shock, and more than 30% of hospital-acquired infections. These patients tend to be very sick and have a high risk of death. We are the pioneer in the treatment of sepsis and septic shock by targeting cytokine storm and deadly inflammation with our European Union approved extracorporeal cytokine adsorber, CytoSorb®. But we believe the combination of extracorporeal cytokine and endotoxin removal from blood, in conjunction with antibiotics, may be an even more effective therapy for Gram-negative infections, and will help us to save more lives. We are grateful for the support from NIGMS to conduct the preliminary in vitro work needed before we evaluate our new polymers in a pig model of Gram-negative sepsis in the future."
Sepsis is the overzealous immune response to an infection and is responsible for approximately one in every five deaths worldwide each year. This has led the World Health Organization (WHO) to declare it a "global health priority." Sepsis accounts for approximately 10-20% of all intensive care unit (ICU) admissions, where patients either have sepsis when admitted to the ICU, or develop sepsis as a result of a nosocomial or hospital-acquired infection while in the ICU. Gram-negative infections commonly trigger septic shock, a serious complication of sepsis where the blood pressure drops to dangerously low levels and organ failure and death can ensue. Despite antibiotics and the best standard of care, septic shock still has a mortality of 35-50%.
The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking 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 $48 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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Company Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@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 -- Lineage Cell Therapeutics Appoints Jill Howe as Chief Financial Officer
CARLSBAD, Calif., October 31, 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, announced today that Jill Howe will join as the Company’s Chief Financial Officer, effective November 14, 2022. Ms. Howe brings more than 20 years of significant strategic, financial, and operational experience to Lineage, with an emphasis on capital strategy, corporate finance, treasury management, global infrastructure, and operational excellence. Ms. Howe has successfully built biotechnology organizations and implemented operational infrastructures alongside the execution of over $1.66 billion of capital raising transactions and will bring extensive strategic experience to the role. Most recently, Ms. Howe was Chief Financial Officer of DTx Pharma, and prior to that, was Vice President of Finance and Treasurer at Gossamer Bio, Inc., serving an integral role in the company’s initial public offering (IPO) and concurrent listing on the Nasdaq Global Select Market, various follow-on and debt deals, and overseeing all aspects of finance and accounting operations globally.
"Jill is a wonderful addition to our executive team as we work to establish Lineage as a leader in cell therapy and cell transplant medicine," stated Brian M. Culley, Lineage CEO. "She is a successful executive with an extensive track record of execution in capital raising, strategic financial management, global expansion, and support, as well as mergers & acquisitions, and reflects the newest expansion of our team. Our continued growth will allow Lineage to exhibit greater productivity and increase the breadth of what we are able to accomplish in the months and years ahead."
Ms. Howe most recently served as Chief Financial Officer of DTx Pharma, a biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease. From 2018 to 2021, she served as Vice President of Finance and Treasurer for Gossamer Bio, Inc. (NASDAQ: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, where she managed all aspects of finance operations, accounting, and global IT and real estate efforts, including the building-out of world-class labs and office space. She also served as a Board member of all Irish and Luxembourg subsidiaries of Gossamer Bio. From 2016 through 2017 she served as Controller & Director of Finance at Amplyx Pharmaceuticals, Inc., a company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems, which was subsequently acquired by Pfizer, Inc. From 2013 to 2016 she served as Controller & Director of Finance at Receptos, Inc. (NASDAQ: RCPT), which was subsequently acquired by Celgene, Inc. for more than $7 billion. Prior to that, from 2006 to 2013 she worked in various accounting roles, leading up to Director of Finance, at Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), which was acquired by Pernix in 2012. Ms. Howe earned her Bachelor of Arts in Accounting from San Diego State University and serves on the Board of Directors of various nonprofit, private and public biotechnology companies. In 2022, Ms. Howe won the 2022 CFO of the Year Award in the small business category from the San Diego Business Journal and was specifically recognized for her leadership in building and managing successful financial teams, laying the groundwork for success, and as a San Diegan, for contributions to the community through her local charity work.
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 development for the treatment of geographic atrophy secondary to age-related macular degeneration, 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.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: Ms. Howe’s employment with Lineage and the anticipated or implied benefits thereof to Lineage and Lineage’s continued growth and ability to exhibit greater productivity in the future. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221031005220/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Tokens.com Announces Normal Course Issuer Bid Program
TORONTO, October 27, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce the NEO Exchange ("NEO") has accepted its notice to implement a normal course issuer bid ("NCIB") to purchase, for cancellation, up to 3,000,000 of its common shares ("Shares"), or approximately 4.1 percent of the Company's public float, as at October 26, 2022.
Tokens.com’s Board of Directors believes that the market price of the Company's Shares, from time to time, may not reflect the inherent value of the Company and purchases of Shares pursuant to the NCIB may represent an appropriate and desirable use of funds.
"Our shares have been impacted by depressed crypto prices, and macro economic events and headlines, that are not linked to the performance of our businesses. Although our three business segments have positive revenue growth, this has not materialized into market recognition of the value within the Company," said Andrew Kiguel, CEO of Tokens.com. "Tokens.com remains viable, well capitalized, and committed to growing its web3 businesses. Management does not believe that our shares currently reflect the value of the Company."
Purchase of the Shares may commence on November 01, 2022 and will expire on the earlier of October 31, 2023 or the date on which the Company has either acquired the maximum number of Shares allowable or otherwise decides not to make any further repurchases. Purchases of Tokens.com’s Shares under the NCIB may be made through the facilities of the NEO and alternative trading systems by means of open market transactions or by such other means as may be permitted by the Canadian Securities Administrators (the "CSA") and under applicable securities laws, including by private agreement pursuant to issuer bid exemption orders issued by applicable securities regulatory authorities.
The price the Company will pay for any Shares will be the market price at the time of purchase or such other price as may be permitted by the CSA. Any private purchase made under an exemption order issued by a securities regulatory authority will generally be at a discount to the prevailing market price. In connection with the NCIB, Tokens.com will enter into an automatic purchase plan ("Plan") with its designated broker to allow for purchases of its Shares during internal blackout periods. Such purchases would be at the discretion of the broker based on parameters established by the Company prior to any blackout period or any period when it is in possession of material undisclosed information.
Outside of these periods, the Shares will be repurchased in accordance with management's discretion, subject to applicable law. The Plan may be terminated by Tokens.com or its broker in accordance with its terms or will terminate on the expiry of the NCIB. As of October 26, 2022, the Company has 96,926,757 Shares issued and outstanding and a public float of 72,377,444. Tokens.com will not acquire, through the facilities of the NEO and alternative trading systems, more than 56,146 Shares during a trading day (which is equal to 25% of 224,586 Shares, being the average daily trading volume on all exchanges for six calendar months prior to the date hereof), subject to certain exceptions for block purchases. The actual number of Shares that will be repurchased under the NCIB, and the timing of any such purchases, will be determined by Tokens.com on management's discretion, subject to applicable securities laws. There cannot be any assurances as to how many Shares, if any, will ultimately be acquired by the Company.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-looking Statements
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/20221027005618/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 Normal Course Issuer Bid Program
TORONTO, October 27, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce the NEO Exchange ("NEO") has accepted its notice to implement a normal course issuer bid ("NCIB") to purchase, for cancellation, up to 3,000,000 of its common shares ("Shares"), or approximately 4.1 percent of the Company's public float, as at October 26, 2022.
Tokens.com’s Board of Directors believes that the market price of the Company's Shares, from time to time, may not reflect the inherent value of the Company and purchases of Shares pursuant to the NCIB may represent an appropriate and desirable use of funds.
"Our shares have been impacted by depressed crypto prices, and macro economic events and headlines, that are not linked to the performance of our businesses. Although our three business segments have positive revenue growth, this has not materialized into market recognition of the value within the Company," said Andrew Kiguel, CEO of Tokens.com. "Tokens.com remains viable, well capitalized, and committed to growing its web3 businesses. Management does not believe that our shares currently reflect the value of the Company."
Purchase of the Shares may commence on November 01, 2022 and will expire on the earlier of October 31, 2023 or the date on which the Company has either acquired the maximum number of Shares allowable or otherwise decides not to make any further repurchases. Purchases of Tokens.com’s Shares under the NCIB may be made through the facilities of the NEO and alternative trading systems by means of open market transactions or by such other means as may be permitted by the Canadian Securities Administrators (the "CSA") and under applicable securities laws, including by private agreement pursuant to issuer bid exemption orders issued by applicable securities regulatory authorities.
The price the Company will pay for any Shares will be the market price at the time of purchase or such other price as may be permitted by the CSA. Any private purchase made under an exemption order issued by a securities regulatory authority will generally be at a discount to the prevailing market price. In connection with the NCIB, Tokens.com will enter into an automatic purchase plan ("Plan") with its designated broker to allow for purchases of its Shares during internal blackout periods. Such purchases would be at the discretion of the broker based on parameters established by the Company prior to any blackout period or any period when it is in possession of material undisclosed information.
Outside of these periods, the Shares will be repurchased in accordance with management's discretion, subject to applicable law. The Plan may be terminated by Tokens.com or its broker in accordance with its terms or will terminate on the expiry of the NCIB. As of October 26, 2022, the Company has 96,926,757 Shares issued and outstanding and a public float of 72,377,444. Tokens.com will not acquire, through the facilities of the NEO and alternative trading systems, more than 56,146 Shares during a trading day (which is equal to 25% of 224,586 Shares, being the average daily trading volume on all exchanges for six calendar months prior to the date hereof), subject to certain exceptions for block purchases. The actual number of Shares that will be repurchased under the NCIB, and the timing of any such purchases, will be determined by Tokens.com on management's discretion, subject to applicable securities laws. There cannot be any assurances as to how many Shares, if any, will ultimately be acquired by the Company.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
Forward-looking Statements
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/20221027005618/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 -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Monday, November 7, 2022, at 8:30 a.m. ET
SAN DIEGO, Calif. and CALGARY, AB, Oct. 27, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Monday, November 7, 2022, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter of 2022.
Conference Call & Webcast
Date: Monday, November 7, 2022
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 664-6383
Dial In – International: (416) 764-8650
Conference ID (if needed): 4240-6541
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the mode of action and potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' 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
NEWS -- Tokens.com subsidiary, Hulk Labs, Integrates over 1000 Players into its Player Network
TORONTO, October 26, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce its subsidiary, Hulk Labs, has successfully integrated over a thousand player wallets into its network, with a primary focus on Africa.
Hulk Labs has initially allocated over US$100,000 into gaming assets that have been deployed to players in Africa, in markets including Tanzania, South Africa, and via its exclusive contract with the Democratic Republic of Congo ("the DRC"). To date, gaming assets in its top titles (Crabada and Thetan Arena) are returning between 18% and 24% per month in revenue. Hulk Labs has over 3,000 players on the waitlist to join its network across Africa. It is expected that Hulk Labs will continue to add hundreds of players each month and deploy further capital, with a target of getting to 10,000 players by the end of 2023.
Hulk continues to leverage its in-house software tools to scale its ability to manage a growing number of assets and players. In addition, in 2023, Hulk Labs will begin beta testing proprietary software that will connect its player network to interested investors, similar to how Uber connects passengers to drivers.
"Hulk Labs which has grown exponentially since its launch earlier this year and has sights on becoming one of the largest gaming guilds in the world," said Andrew Kiguel, CEO of Tokens.com. "Our partnerships in Africa successfully created new income opportunities leveraging the blockchain. We will continue to forge the business ahead and will be well equipped for when the crypto markets turn."
Hulk Labs is focused on three primary objectives. The first is identifying the best income-generation opportunities across the P2E economy by evaluating hundreds of the top P2E games and creating calculators to evaluate the profit potential and expected longevity of the games. Hulk Labs publishes many of these calculators at hulklabs.com for no cost.
Second, Hulk Labs buys P2E gaming assets (NFTs) that identify with the most profit potential and delegates them to a network of players in its network, located primarily in Africa.
Finally, the Company continues to build tools to streamline the delegation (sharing) and tracking of its P2E assets to various players. Hulk Labs has built tools to securely create and monitor thousands of cryptocurrency wallets, administer assets to these wallets while still maintaining custody of its assets, track player performance during gameplay, and streamline the transfer of tokens required for gameplay. The team is focused on scaling its products to support a wide variety of blockchains and games.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that invests in web3 assets and businesses.
For further information please visit https://hulklabs.com.
Forward-looking Statements
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/20221026005148/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 subsidiary, Hulk Labs, Integrates over 1000 Players into its Player Network
TORONTO, October 26, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in web3 assets and builds businesses linked to crypto staking, the metaverse and play-to-earn gaming, is pleased to announce its subsidiary, Hulk Labs, has successfully integrated over a thousand player wallets into its network, with a primary focus on Africa.
Hulk Labs has initially allocated over US$100,000 into gaming assets that have been deployed to players in Africa, in markets including Tanzania, South Africa, and via its exclusive contract with the Democratic Republic of Congo ("the DRC"). To date, gaming assets in its top titles (Crabada and Thetan Arena) are returning between 18% and 24% per month in revenue. Hulk Labs has over 3,000 players on the waitlist to join its network across Africa. It is expected that Hulk Labs will continue to add hundreds of players each month and deploy further capital, with a target of getting to 10,000 players by the end of 2023.
Hulk continues to leverage its in-house software tools to scale its ability to manage a growing number of assets and players. In addition, in 2023, Hulk Labs will begin beta testing proprietary software that will connect its player network to interested investors, similar to how Uber connects passengers to drivers.
"Hulk Labs which has grown exponentially since its launch earlier this year and has sights on becoming one of the largest gaming guilds in the world," said Andrew Kiguel, CEO of Tokens.com. "Our partnerships in Africa successfully created new income opportunities leveraging the blockchain. We will continue to forge the business ahead and will be well equipped for when the crypto markets turn."
Hulk Labs is focused on three primary objectives. The first is identifying the best income-generation opportunities across the P2E economy by evaluating hundreds of the top P2E games and creating calculators to evaluate the profit potential and expected longevity of the games. Hulk Labs publishes many of these calculators at hulklabs.com for no cost.
Second, Hulk Labs buys P2E gaming assets (NFTs) that identify with the most profit potential and delegates them to a network of players in its network, located primarily in Africa.
Finally, the Company continues to build tools to streamline the delegation (sharing) and tracking of its P2E assets to various players. Hulk Labs has built tools to securely create and monitor thousands of cryptocurrency wallets, administer assets to these wallets while still maintaining custody of its assets, track player performance during gameplay, and streamline the transfer of tokens required for gameplay. The team is focused on scaling its products to support a wide variety of blockchains and games.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these three segments.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Crypto gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a web3 technology company focused on building tools and systems to generate income from Play-to-Earn (P2E) blockchain games. Hulk Labs builds calculators to evaluate the profit potential and longevity of P2E games. In addition, the company is building a global player network to play games on behalf of asset-holders and is building tools to securely delegate and track in-game NFTs. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that invests in web3 assets and businesses.
For further information please visit https://hulklabs.com.
Forward-looking Statements
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/20221026005148/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 -- Plus Therapeutics Announces Selection of “Rhenium (186Re) Obisbemeda” as International Non-Proprietary Name for 186RNL
AUSTIN, Texas, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that the World Health Organization’s (WHO) International Non-proprietary Name (INN) Expert Committee has selected the non-proprietary name “Rhenium (186Re) obisbemeda” for the Company’s lead investigational targeted radiotherapeutic, formerly known as 186RNL. Going forward, Plus Therapeutics will use Rhenium (186Re) obisbemeda in place of 186RNL.
“The assignment of Rhenium (186Re) obisbemeda as the recommended INN for 186RNL is another important milestone in the ongoing development of our lead targeted radiotherapeutic as we plan to move it towards mid- and late-stage clinical development, including a planned Phase 2 trial in patients with recurrent glioblastoma by the end of 2022,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.
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 Rhenium (186Re) obisbemeda including the ability of Rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of Rhenium (186Re) obisbemeda; the continued evaluation of Rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Provectus Biopharmaceuticals Expands Research Collaboration with The Rockefeller University to Investigate Clinical-Stage Immuno-Dermatology Agent PH-10 for Skin Inflammation
KNOXVILLE, TN, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has expanded its sponsored research program with James G. Krueger, MD, PhD, Co-director, Center for Clinical and Translational Science, D. Martin Carter Professor in Clinical Investigation, Senior Attending Physician, and head of the Laboratory of Investigative Dermatology at The Rockefeller University to investigate the potential for PH-10, a topical formulation of Provectus’ pharmaceutical-grade small molecule rose bengal sodium (RBS) drug substance, to directly alter the growth and differentiation of human keratinocytes, and to block cytokine-mediated signaling that creates different inflammatory skin diseases and may also be important in skin neoplasms.
PH-10 is an immuno-dermatology, multi-indication viable, clinical-stage pharmaceutical asset that the Company has used to treat more than 200 patients in multiple early- and mid-stage clinical trials for psoriasis and atopic dermatitis.
Dr. Krueger and the Laboratory of Investigative Dermatology plan to examine the effects of a wider range of PH-10 concentrations on human keratinocytes in vitro at the level of gene transcription. They also hope to determine PH-10’s interaction with and uptake by blood leukocytes, because these cells mediate inflammatory skin diseases and control or protect against some types of skin cancers.
The Kruger team previously elucidated several PH-10 mechanisms of action from work that it did as part of a Provectus clinical study of psoriasis, showing that: