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NEWS -- Plus Therapeutics Presents Positive Data from Ongoing ReSPECT™ Clinical Trials at the Annual Conference on CNS Clinical Trials and Brain Metastases
AUSTIN, Texas, Aug. 13, 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, yesterday presented positive data from two ongoing clinical trials of its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), in the treatment of recurrent glioblastoma (GBM) and leptomeningeal metastases (LM) at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases. The conference is co-sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) and is being held August 12-13, 2022 in Toronto, Canada.
The oral presentation, titled Safety and Feasibility of Rhenium-186 Nanoliposome (186RNL) in Leptomeningeal Metastases Phase 1/2a Dose Escalation Trial [LOCL-04], demonstrated that the 186RNL dose administered through an intraventricular catheter at 6.6 mCi in 5.0 mL achieved absorbed doses of 18.7 to 29.0 Gy to the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events of greater than grade 1. Furthermore, all three patients in the cohort were observed to have prompt and complete 186RNL distribution throughout the cerebrospinal fluid (CSF) subarachnoid space that was durable past one week and very well tolerated. Importantly, all patients showed a decreased CSF cell count by microfluidic chamber assay after treatment, ranging from 65% to 92% which was also durable.
“While we can draw only limited conclusions from the first patient cohort, these findings suggest that the application of locally delivered and highly targeted 186RNL for the treatment of LM has the potential to be an effective and safe treatment for patients,” stated Norman LaFrance, M.D., Chief Medical Officer and SVP at Plus Therapeutics.
“Leptomeningeal metastases are a devastating complication of cancer that often force patients to choose between toxic therapies or a limited life expectancy that builds on top of the already complex burden of their underlying cancer. However, our approach to deliver 186RNL is precisely targeted to the CNS and minimizes radiation exposure to other parts of the body and importantly has the potential to extend patient survival,” 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-LM clinical trial. “We look forward to continuing the clinical evaluation with additional dose escalations to further assess 186RNL’s versatility and on behalf of patients in need.”
Dr. Brenner also presented a poster titled, Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1 Trial [LOCL-08], which demonstrated that in 23 subjects with recurrent GBM receiving a single administration of 186RNL, significant overall survival benefits were observed in those achieving an average absorbed radiation dose greater than 100 Gy to the tumor compared to those with less absorption. These findings suggest a correlation in increasing convected drug volume and radiation dose with improvement in overall survival of patients and to date, 80% of patients in cohorts 5-7 met the threshold of high levels of absorption greater than 100 Gy.
Data show 186RNL treatment is safe and well-tolerated, with no adverse events (AEs) with outcome of death or discontinuations. At the time of the presentation, four patients remain alive. Cohort 7 of the trial, with an increased dose of 186RNL (31.2 mCi and infusate volume 12.3 mL), is currently enrolling.
“Taken together, these data from both ReSPECT-LM and ReSPECT-GBM represent Plus’ ongoing dedication to evaluating 186RNL in clinical settings and the encouraging results showing our product is safe and effective in treating these difficult-to-treat cancers,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “As we look ahead to the rest of 2022, we remain focused on completing key manufacturing, clinical and regulatory milestones that will support the further development and validation of 186RNL so we can quickly bring our therapy to patients.”
A copy of the poster and presentation will also be available under the Presentations tab of the Investors section of the Company’s website at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Lineage to Present at H.C. Wainwright & Co. 2nd Annual Virtual Ophthalmology Conference
CARLSBAD, Calif., August 15, 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 Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC. The fireside chat will be available to investors on demand, starting on August 17th, 2022 at 7am ET.
Interested parties can register to view on-demand replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220815005164/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Plus Therapeutics Announces Share Repurchase Program
Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that its Board of Directors has approved a share repurchase program with authorization to repurchase up to $2.0 million of the Company’s outstanding common stock. The Company intends to fund any share repurchases with available cash.
“This share repurchase program reflects our continued confidence in our long-term strategy and the strength of the balance sheet and reinforces our commitment to deliver value to shareholders,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.
The timing and amount of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors, including consent of the Company’s lender. Repurchases may be made from time to time on the open market over the next 12 months, in privately negotiated transactions or by other means, including through the use of trading plans intended to qualify under Rule 10b5-1. Repurchases will be made in accordance with the rules and regulations promulgated by the Securities and Exchange Commission. The Company is not obligated to acquire any shares and the program may be discontinued or suspended at any time.
About Plus Therapeutics, Inc.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the Company’s intended share repurchases, long-term strategy and expected shareholder benefits.
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: difficulties in assessing expected operating expenses and available cash on hand; consent of the Company’s lender to the share repurchase program; the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Lineage Cell Therapeutics, Inc. (LCTX) Q2 2022 Earnings Call Transcript
By Motley Fool Transcribing - Aug 12, 2022 at 2:31AM
Q2 2022 Earnings Call
Aug 11, 2022, 4:30 p.m. ET
Contents:
Prepared Remarks
Questions and Answers
Call Participants
Prepared Remarks:
Operator
Welcome to the Lineage Cell Therapeutics second quarter 2022 conference call. [Operator instructions] An audio webcast of this call is available on the investors section of Lineage website at www.lineagecell.com. This call is subject to copyright and is the property of Lineage. And recordings, reproductions or transmission of this call without the expressed written consent of Lineage are strictly prohibited.
As a reminder, today's call is being recorded. I would now like to introduce your host for today's conference, Ioana Hone, head of investor relations at Lineage. Ms. Hone, Please go ahead.
Ioana Hone -- Head of Investor Relations
Thank you, Brianna. Good afternoon and thank you for joining us. A press release reporting our second quarter 2022 financial results was issued earlier today, August 11, 2022, and can be found on the Investors section of our website. Please note that today's remarks and responses to your questions reflect management's views as of today only and will contain forward-looking statements within the meaning of federal securities laws.
Statements made during this discussion that are not statements of historical fact should be considered forward-looking statements, which are subject to significant risks and uncertainties. The company's actual results or performance may differ materially from the expectations indicated by such forward-looking statements. For a discussion of certain factors that could cause the company's results or performance to differ, we refer you to the forward-looking statements section in today's press release and in the company's SEC filings, including its most recent annual report on Form 10-K and its subsequent quarterly reports on Form 10-Q. We caution you not to place undue reliance on any forward-looking statements, which speak only as of today and are qualified by the cautionary statements and risk factors described in our SEC filings.
With us today are Brian Culley, our chief executive officer and interim chief financial officer, and Gary Hogge, our senior vice president of clinical and medical affairs. Brian will provide some prepared remarks, and then he and Gary will be available for questions from analysts. With that, I'd like to turn the call over to Brian.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Thanks, Hone, and good afternoon, everyone. We appreciate you joining us on the call today. As you know, I currently am serving on an interim basis as the company's CFO. Several weeks ago, we initiated a nationwide CFO search with an accomplished recruiting firm, and we already are connected to some great candidates.
So I'm hopeful we'll have that position fill soon, and we will update you accordingly. Before I provide the business update today and identify a few events you can look forward to. I typically like to start off with a few general comments about the biotech environment and in particular, where I see Lineage within the field of cell therapy. Along those lines, one notable and recent event was yet another non-cancer cell therapy company, catching the attention of a much larger acquirer.
In this case, I'm, of course, referring to the acquisition of ViaCyte by Vertex. Although many investors focus on the oncology side of cell therapy and indeed, that is where cell therapy has established its strongest foothold. Additional success continues to occur among non-cancer cell therapy companies, such as through the acquisitions of Sema, BlueRock, most recently ViaCyte. And I would also include the partnership which we struck with Roche and Genentech as another significant event for the field of cell transplant medicine.
Reflecting positively on both IPS and ES companies and especially compared to some of the setbacks we've seen with certain mesenchymal or undifferentiated cell therapy companies. And as this field matures and more and more clinical data are generated, it increasingly appears that cell transplants when deployed in the right setting with the right delivery tools have the potential to become an important new branch of medicine. For this reason and others, Lineage will continue to try and position ourselves as a leader in this space through the combination of internal and partnered product development efforts. Thinking next about where Lineage sits within this emerging and promising field as a business and as an investment, I believe we continue to be in an environment where companies with three key characteristics may be in a better position than others to create value in the coming months and years.
Those three characteristics are, one, having multiple years of cash. Two, having deals with big pharma companies. And three, having diversification through a portfolio of assets, preferably clinical-stage assets because those typically offer shorter timelines to approval than do preclinical ones. In those three features, cash, validation and a pipeline are attributes of Lineage, which I believe put us in a strong position to attract shareholder interest in the months and years ahead, and I'd like to touch on each of them briefly today.
Starting with cash, it is clear that the biotech industry continues to be in a period of uncertainty and volatility. And for this reason, we have persisted with our disciplined use of capital. As of the end of the second quarter, we had a projected cash runway of at least two years. I will add that those two years do not include any cash milestones from the Roche agreement, which we may receive during that period.
This runway also does not include any revenues from business development deals, although we are putting greater efforts behind that area as well. As noted in today's press release, we expanded one of our existing agreements last quarter and have initiated multiple discussions for additional corporate alliances, which might help fund or otherwise enhance our assets. And as you know, we continue to be in close contact with SERM and intend to see grant support for the OPC1 program. We may consider SERM support for other programs as well.
So as I have said before and can reiterate again today, we believe Lineage continues to be in a period of good financial health, which allows us to focus on creating value across the spectrum of short, medium and most importantly, long-term time frames. With respect to the second attribute, validation from big pharma, everyone by now is aware of the alliance we entered into with Roche and Genentech last year for the development of OpRegen for dry-AMD with GA or as it is now called by Roche, RG6501. Although we're not able to share specifics, we're extremely pleased with the progress of OpRegen development since entering our collaboration with Roche and Genentech and the resources, which have been allocated to its furtherance. Most of the details are internal to the two companies, but I am able to say that during the second quarter, we made progress across all of the primary functional areas, including clinical, regulatory and manufacturing technology transfer activities, which are reflected in the additional $4.1 million of revenue recognized in the second quarter.
Lineage successfully completed additional manufacturing runs of OpRegen, along with their associated CMC activities. We continued with the planned technology transfer activities and held a series of joint advisory and separately joint manufacturing committee meetings, which are collaborative forums for discussion and planning for the next steps for OpRegen and its related activities. Long-term follow-up of patients from the phase 1-2A clinical study, which Lineage conducted is also ongoing. And most notably, those enrolled patients are still doing well, which supports the multiyear durability of a treatment effect with operegen.
Bolstered by the compelling body of data, which we generated from OpRegen in an early clinical trial, we will continue to work closely with the teams at Roche and Genentech to offer our support and experience and advance OpRegen ever closer to later-stage trials. We believe the results we have observed to date with OpRegen compare favorably against the various efforts focused on complement inhibition, which require a lifetime of frequent dosing, offer only a modest effect on GA progression and to our knowledge, have no or a minimal effect or benefit on visual acuity. For these reasons and many others, we're excited about generating further clinical data from this program as soon as possible. And thirdly, with respect to the diversification, which our promising and recently expanded pipeline offers to investors, the team made excellent progress in multiple areas with a particular focus on advancing certain clinical and regulatory steps, which are not only necessary to support any future trials, but also reduce risk across our portfolio.
In particular, efforts were made to prepare for regulatory interactions for both our OPC1 and VAC2 programs, which are necessary to support their next phases of clinical testing and spinal cord injury and oncology, respectively. And we also continue to engage in manufacturing and preclinical activities for our newly launched cell transplant programs for hearing loss and vision disorders. I'll add that activities which will support our regulatory interactions for OPC1 are nearing completion, which I believe is a positive reflection of our efforts to reduce cell therapy development timelines. Our new thaw and inject formulation of OPC1, which we manufactured via an improved and larger scale process has been undergoing preclinical testing, and I'm pleased to share today for the first time that our OPC1 cells from the improved formulation and process have successfully demonstrated functional recovery in a clinically relevant animal model for spinal cord injury, including improvement in gate coordination and motor performance, along with cell engraftment, which manifests as a reduction of the area of cavitation in the spinal cord.
These findings are consistent with prior data generated from a less efficient and lower scale manufacturing process, so we are delighted that our new and improved process has performed as intended in these studies. We expect that these results will be submitted and available for publication and review. In conjunction with our efforts on the cell side, the other cell side, we have been working on an improved delivery system for OPC1. We believe the novel delivery system, which we licensed from near gain will offer a safer and easier-to-use method for delivering OPC1, and I'm able to share today that most of the verification and validation activities for this delivery system, including its preclinical testing in support of a regulatory submission have been completed, which moves us closer to our goal of filing an IND amendment and testing the DFD clinically.
With both the cell and delivery activities making excellent progress this past quarter, we have reengaged with the California Institute of Regenerative Medicine, or CIRM, to open discussions about providing some financial support for this trial. We also have been reengaging with various industry and caregiver groups such as Spinal Cord Outcomes Partnership Endeavor, and American Spinal Injury Association, as well as with the contemporary thought leadership in spinal cord injuries and with prior study participants. Everything seems to be coming together nicely for the OPC1 program, which I will remind you, will include for the first time administering OPC1 to patients with chronic spinal cord injuries, not just sub-acute injuries in our planned clinical trial to evaluate the safety and performance of the novel delivery device. As OPC1 gets increasingly closer to returning to clinical testing, it's worth remembering why we are so excited to continue this program.
Now, I won't repeat my usual comments about the enormous unmet medical need or the absence of any approved treatments but refer you instead to prior clinical data. The full study results from the 25 patients enrolled in the Phase 1-2A clinical study in sub-acute cervical spinal cord injury were recently published in the Journal of Neurosurgery Spine. In that publication, it was reported that OPC1 demonstrated an excellent safety profile and at one year post treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body compared to an expected control rate of approximately 68% according to CSL. In addition, 32% of patients in that study recovered two or more levels of neurological function on at least one side of their body, which again is higher than what Steeves and Llull would have anticipated.
For these reasons and because there were many lessons learned from the initial trial of OPC1, which we aim to incorporate into the next study, we are very excited to put OPC1 back into clinical testing and evaluate the potential for our replace and restore technology to provide outsized clinical outcomes in spinal cord injury, not unlike our experience to date with the restoration of retinal tissue observed with OpRegen in the setting of dry-AMD. Moving next to our VAC2 program. We have similarly continued to make progress toward an IND submission in preparation for potential U.S. clinical testing next year.
I'd like to remind everyone first that Cancer Research U.K. continues to follow patients in the phase one clinical study of VAC2 in non-small cell lung cancer, and the public release of clinical study results is entirely subject to their discretion and control. However, our team has received all the necessary clinical information, which is required to support the regulatory interactions which we are working toward in the U.S. Depending on the outcome from those FDA interactions, we would be permitted to conduct clinical testing of VAC2 at U.S.
Centers for the first time. As we work toward those FDA interactions, I can update you today to share the following technology transfer of the VAC2 program from Cancer Research U.K. to Lineage, the Lineage team engaged in efforts to optimize the manufacturing process. The manufacturing team was able to successfully increase the production scale to a level compatible with early stage testing while also significantly reducing our cost of goods.
I will add that part of the reduction in the cost of goods was due to scale, but a large amount of that reduction was attributable to new methods of production, which we deploy. The team also made marked improvements in the purity and functionality of the product candidate reflected in surface marker expression and in vitro functionality tests. I want to diverge for just a moment to highlight something, which I think has gone under the radar for some time. These manufacturing achievements, which I'm describing today reflect the third time for which Lineage's manufacturing team was able to meet ambitious production goals, goals which were unattainable by multiple prior sponsors and contract manufacturers.
Manufacturing specific cell populations in a reproducible and consistent manner is extremely difficult. And doing so using a process that can not only support initial clinical testing, but also have a line of sight on to a commercial platform is something we've done twice. First with OpRegen, then again with OPC1, and now we've nearly accomplished the third time with our dendritic cell program. I don't think we get full credit for our manufacturing capabilities today, but I do think awareness is rising about how the manufacturing portion of cell therapy product development is so critical and how doing it well can greatly reduce development cycles and avoid regulatory delays, the likes of which we have seen at some other companies.
But I also believe that with additional time and success, the capabilities and know-how of the Lineage's manufacturing team will be more fully appreciated. Returning back to our pipeline programs. I'll conclude by adding that we also have continued to advance our auditory neuron and photoreceptor programs. They both are proceeding through the required preclinical development manufacturing activities, which are necessary to support initial clinical testing.
And as we generate data or have other interesting events, which we can share with you, you can expect updates from time to time on those two programs. Overall, our efforts at this time remain focused on conducting our share of the OpRegen development activities, as well as successfully completing a diverse set of regulatory preclinical and clinical events for our pipeline. Events, which will provide not only clarity on our development time lines, but also help de-risk and increase the value of our various assets. And because we're doing this work among the tailwinds of multiple years of cash, a big pharma partnership and a diverse set of unique yet related cell therapy assets, I'm encouraged by what the future may hold for Lineage.
A handful of specific goals and objectives, which I'd like to invite you to be aware of include a planned interaction with the FDA in Q4, where we intend to discuss our OPC1 IND amendment submission to enable the clinical performance and safety testing of the novel delivery system in acute and chronic spinal cord injury patients. Second, a pre-IND regulatory interaction with the FDA also in Q4 to seek feedback on a VAC2 CMC nonclinical and clinical package to support U.S. clinical development. Third, evaluation of new partnership opportunities and/or expansion of existing collaborations, you saw recently that we are successful in expanding an existing collaboration with ABM for our HyStem technology and that we continue to work with our partner, Immunomic Therapeutics.
But we also would like to enter into additional alliances with larger economic benefits to Lineage and are aggressively seeking to identify opportunities to enter into such corporate alliances and help advance our assets. Fourth, we intend to submit a grant application to SERM for the continued support of the clinical development of OPC1. And fifth, we intend to generate preclinical data to support a pre-IND meeting with the FDA for our new auditory neuron program. We, of course, have other goals, but the ones that I've highlighted today, in particular, will provide additional regulatory and spending clarity and potential de-risking of our programs.
We believe that execution of these goals will continue to demonstrate our ability to successfully advance novel cell therapy product candidates. OK. With that, let me put on my interim CFO hat and turn next to our financial results. With respect to our balance sheet, we continue to be in a comfortable position as we expect to have more than two years of liquidity, not accounting for any of the Roche and Genentech milestones, which we may receive in the next two years nor for any business development or grant revenues, which we may receive.
Our reported cash, cash equivalents and marketable securities as of Q2 totaled approximately $72 million. In comparison, our normalized net operational spending for the past two years was between $20 million and $25 million. So even though we likely will see that amount be closer to $30 million this year, we have more than doubled that amount in the bank and can continue to just focus on running the business. Total revenues for the second quarter were approximately $4.6 million, an increase of $4 million, representing an increase of over 700% compared to the same period in 2021.
The increase was due primarily to licensing fees in connection with the Roche collaboration agreement and reflecting our share of collaboration responsibilities. The largest portion of the activity attributed to this revenue was OpRegen manufacturing costs, but also include personnel, materials and clinical consulting expenses. As you may recall, we received a $50 million upfront payment from Roche in January on a cash basis, but on a GAAP basis, we are recognizing that $50 million over time as opposed to a point in time and utilizing an input method of costs incurred over total estimated costs to complete our performance obligations. The accounting recognition for the Roche upfront payment generally resembles a percent complete methodology but is a reflection of our proportional contribution and may vary from quarter to quarter.
Overall, our revenue recognition for the second quarter was largely in line with our expectations. Total operating expenses for the second quarter were approximately $8.6 million, an increase of approximately $1.1 million compared to the same period in 2021. The increase was a result of increased R&D spending of approximately $400,000, primarily related to development activities in our new auditory neuron and photoreceptor cell therapy programs, as well as an increase in OpRegen related expenses to support the Roche collaboration. Furthermore, G&A expenses were up by approximately $700,000, mostly related to higher stock-based compensation and payroll and related benefits expense.
Our loss from operations for the second quarter was approximately $4.2 million, a decrease of $2 million compared to the same period in 2021, resulting from the aforementioned $4 million increase in revenues and offset with a $1.1 million increase in operating expenses. The net loss attributable to Lineage for the second quarter was $6.8 million or $0.04 per share. And as we always say at this point in the call, it's important to remember that the variance between our loss from operations and our overall net loss is impacted by changes in the value of our investments, as well as by foreign currency exchange rate fluctuations related to our international subsidiaries. While these nonoperational fluctuations are important, we tend to utilize loss from operations as a more relevant measurement with regard to our clinical programs.
Turning to the balance sheet. We reported cash and cash equivalents and marketable securities of approximately $72 million as of quarter end. And additionally, as disclosed as a subsequent event in our recently filed 10-Q, during July, we also received approximately $0.9 million in net proceeds from a warrant exercise at our subsidiary in Israel. As I mentioned earlier, we anticipate a modest increase in our normalized net spending this year compared to the prior year because our programs increased in number and continue to advance toward their next clinical trials.
And we have certain performance obligations under the Roche agreement such as supplying OpRegen cells for the next clinical trial. But as I also noted earlier, we estimate our net operational spend for 2022 on a normalized basis will be less than $30 million. Overall, we intend to maintain the same spending discipline that we have adhered to so far and which has served us well in the past. We believe that this spending discipline, alongside our cash balance puts us in a good position to create value for shareholders from our investments.
Our guiding principle at Lineage is to advance the emerging technology of cell transplant medicine and to show the potential for those transplants to outperform traditional approaches by providing the product attributes and rigorous clinical testing necessary to achieve commercially successful medicines in areas of high unmet need. To that end, we believe we have not only generated evocative data from our current clinical programs, but also have the opportunity to do so with our earlier stage initiatives. We've made significant investments in and improvements to areas such as production, scale, purity and delivery of our differentiated cells, which, overall, we believe, is a proven path to creating best-in-class products for end users and strong competitive advantages to protect lineages and our current and potential partner sales over the long term. We also are working hard to identify and execute on measures which can reduce cell therapy development timelines, which we believe is a new area of opportunity in this young field.
Wrapping up, as I speak with you today, we are confident in our cash position, our corporate alliances and our diverse portfolio of assets from which we can seek to optimize an attractive mix of development partnerships and internally developed programs. There is a lot to like about where we are today and much to anticipate from us in the coming weeks, months and years. We sincerely appreciate your support as we continue to position Lineage to become a leader in cell therapy and cell transplant medicine. And with that, operator, we are ready to respond to any questions from research analysts, which may be incoming.
Questions & Answers:
Operator
[Operator instructions] Your first question comes from Mayank Mamtani with B. Riley Securities. Your line is now open.
William Wood -- B. Riley Securities -- Analyst
Thank you so much. This is William Wood on for Mamtani. Brian, congratulations to you and the Lineage team for another very productive quarter. Just a couple of questions from us here.
So just thinking about OPC1, maybe even in terms of OpRegen, where it sometimes takes a little bit longer for the sales to get in and really do what they're supposed to do and to really get the results you're looking for, obviously, already shown very nice results with OPC1 at one year. Just curious about some of the longer-term data for efficacy, potentially maintenance or even improvements or alternatively degradation of the recovery for our OPC1 treated from the side star or potentially even from earlier trials. Is that the recovery is maintained? And extra color, that would be great.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. So I'll invite Gary Hogge to comment. I think I'll just preface by saying it's a question we all have. I mean, how durable are these cells.
They continue to persist in patients. And so, potentially, they will essentially outlive the people that they are transplanted into. But Gary could be a little more specific about how long we monitor patients and how long we've seen these kinds of benefits.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Yes, sure. Thanks, Brian. So William, what we've observed to date is that the cells appear to persist at the site of administration so they don't migrate anywhere, they stay where they were put. And all systems on the MRI findings to date would say that they're durable up to the length of follow-up, which is greater than 10 years in some patients at this point.
So as we complete some of the additional animal models and look for the durability response in the animals, we didn't think that that will follow through with our individual patients. And one thing they were doing shortly is there'll be a management looking at the MRI finding, specifically to show that those improvements from the site of administration are maintained for a period of time. As Brian said, sometimes the patients with rehab also continued to improve, even if they don't necessarily gain multiple levels on the different assessments, but individual ability to move fingers or digits or risks can definitely improve quality of life. So we're also looking at being able to publish some of those data.
William Wood -- B. Riley Securities -- Analyst
Also curious, you've discussed a lot with potential partnerships or collaborations. I'm just curious where you've seen the most interest as far as from external programs looking at your specific internal programs, even considering also there's the most interesting manufacturing side of things? And then maybe kind of in addition to that, if there is a scenario where you potentially see sort of your manufacturing side spin out from the clinical development side or something to that degree? Just any extra information there.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. So as you know, I can't comment specifically on any discussions or any specific companies. What I'm able to say is that we are aware in particular, in an environment like we're in right now in biotech that there's trends benefit if you have a platform technology of working with multiple corporate partnerships because you're able to just conduct so much more, many more shots on goal, so much more productivity when you've got multiple parties working. The challenge for any company is if you have choices deciding how to sort of divide up a large either intellectual property estate or different parts of technology and sometimes parts of the technology overlap.
For example, there may be certain applications of intellectual property with respect to a manufacturing process, which we could deploy across related indications. And so, sometimes, you have to make decisions about how you're going to kind of divide up the pie if you have the opportunity to make those choices. So we're really keen to accelerate our product development because we obviously cannot manage 5 simultaneous pivotal trials. So we're really supportive and interested in business development.
Generally, with respect to more strategic considerations like manufacturing, I can't imagine scenarios where utilizing our manufacturing expertise could be valuable to our company. But I want to caution everyone that that does not mean turning into a lower-margin manufacturing CRO business. We'll always want to have a meaningful piece of the upside for any program. So I want to be clear that our jobs here involve creating value and sometimes that might mean you go in an unexpected direction in order to create that value, and that's OK.
But I do think that we recognize that our contribution and getting the best economics from any future deal is going to be driven by having a lot of value behind our contribution and not I would say, diminishing it or allowing us to get into relationships where we're not going to be paid a fair value for our contribution. So I recognize that that is very sort of a generic sort of response for reasons that you're already aware of. But nonetheless, these are the realities of how we view our business and what we have to offer.
William Wood -- B. Riley Securities -- Analyst
Yeah. No, that's. It's very helpful. I think I'll leave it there.
I appreciate it, Brian. Congratulations again to you and the team and, yes, congratulations.
Operator
Your next question comes from Kristen Kluska with Cantor Fitzgerald. Your line is now open.
Rick Miller -- Cantor Fitzgerald -- Analyst
Good afternoon. This is Rick for Kristen. We have two for you here. In the photoreceptor program, with the caveat that, of course, is in preclinical development still ongoing.
Are you thinking about -- how are you thinking about potential learning that might be carried over from the OpRegen program in terms of delivery and the importance of covering affected areas of tissue in the ophthalmology space?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Yes. I mean, I think one of the nice things about introducing another ophthalmology program is that there is much that we can learn, and we already have very established relationships in that space. So it was an easier area for us to get into. But let me again invite Gary to address some more specifics to your question.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Sure. So Rick, one thing is we've certainly got the experts in retinal physiology and disease cause disease at the back and call at this point is they're very engaged with the OpRegen data. So one thing we learned from OpRegen is delivery, delivery, delivery is critical. If you make the cells in the and they are the most functional, they will do their job as intended.
So the key alarms that would be early intervention, appropriate delivery in an area that is targeted to make a difference. So there are a number of diseases that impact the photoreceptors as you can imagine, and we're certainly open to considering all of those.
Rick Miller -- Cantor Fitzgerald -- Analyst
OK. And maybe just one more. Looking ahead to regulatory interactions around OPC1, how are you thinking about how the preclinical activities that you mentioned could fit into the meeting? What do you believe regulators are looking for here?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
Well, it's a tough question because it's sort of a moving answer. I think the FDA has been evolving in its own state of maturation in the field of cell and gene therapy. For example, I think that FDA has been increasingly interested in functional assay data from cell therapy manufacturers just to provide one example. We do know that they wanted to see specific to the OPC1 program, information about the device before they reviewed the information about the new process that we are utilizing.
So we're going to follow a sequential path there that they've outlined for us. But this is, I won't say, new territory, but there are not a large number of precedents for delivering cells like this to the spinal cord. So it's difficult for us to know and that, in fact, is part of the reason why we're trying to be comprehensive with our submission and get the agency as much information as we think they're looking for so that we can have some positive outcomes in an area which is breaking some new ground.
Rick Miller -- Cantor Fitzgerald -- Analyst
That's great. Thank you very much.
Operator
Your next question comes from Joe Pantginis with H.C. Wainwright. Your line is now open.
Joe Pantginis -- H.C. Wainwright -- Analyst
Hey, everybody, good afternoon. Thanks for taking the question. If you don't mind, I'd like to ask CFO, Brian, a question first. I appreciate that you give the guidance about a little under $30 million or so for net spent this year.
But I was curious more specifically about the G&A line. That line tends to be a little choppy. Obviously, there are some noncash items that are included there. But I guess I would ask the question this way.
Either does this quarter -- or I'm sorry, the second quarter number represent a baseline. Or how should we sort of view that with regard to the current rightsizing of the company's FTEs?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
As you know, this is my second tour of duty as an interim CFO. So of course, I'm not prepared to answer that question. So G&A was up only about $700,000, a lot of that is in fact, related to personnel. I am aware that many companies have been laying people off and that we are a bit of a salmon going in the opposite direction.
That's wonderful. I mean, that reflects that we're confident that we have the capital to be able to expand sensibly in this environment. And I also believe that we have a wonderful choices out there attributable to the fact that some very high-caliber companies are laying people off. And those people are going to be increasingly interested in a company like Lineage that has capital and some validation from big pharma, etc.
So I think that you could consider it to be more of a new baseline rather than a stand-alone one-off increase in the quarter because a lot of it is connected to personnel and we want to keep those personnel, but I think that's great. Change through growth and adding people is also going to turn into greater productivity and the breadth of what we're able to accomplish. So I'm really happy with where we've come in and our continued disciplined use of capital, and I'm particularly excited about some of the new hires that we've made and some of the candidates that we're continue looking at.
Joe Pantginis -- H.C. Wainwright -- Analyst
And then, I guess, my next question, I mean, it's surrounding Roche, and I know a lot of the details around my question are in the weeds of the confidential documents, but I guess I'll ask it this way. How far will you be taking? Or what do you feel you could share with us with regard to what your remaining responsibilities are with regard to manufacturing and CMC?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
So you're correct. The weeds are, in some places, so I think that they're redacting that information. So I'm not able to say really anything beyond what I shared today. Primarily, our contributions are around manufacturing for the next clinical study, completing the phase 1-2A study, which we already completed enrollment for, but we have to follow up patients.
And we have sorted additional contributions largely in the form of sort of advisory I'd characterize them as advisory contributions. So it's really difficult for me to say anything more than that. However, as we do get closer and as some of the public information does get released, it will be easier for us to be able to either connect some dots or be able to make some explicit statements about the program, it's timeline, revenue recognition and everything in between those two.
Joe Pantginis -- H.C. Wainwright -- Analyst
And then my last question is more of a pie in the sky question because, look, you're very fortunate to have a strong cash balance, especially in this environment. And I'll preface my question by saying, obviously, you have a lot going on. So but with that said, would you be considering at any point? Or are you even bothering to look at any potential technologies or assets to bring in that might be complementary because of the depressed valuations that are out there?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
I think the right answer is always yes. I think that in some environments, you're in a stronger position to be able to consider that. If you got a high equity price and a lot of capital, but I think the reality is that we are always looking at ways that we can accelerate the development of our programs. Are we spending more time thinking about those opportunities than we were one year ago? Yes.
We hired some additional personnel in business development and licensing, and that's one of their areas effort, but I would not say that we have an explicit campaign with narrow search criteria and an engaged investment bank to work on a project that would be beyond the scope of what we're doing. But when the phone rings and people want to talk about alliances, we always pick up and sometimes we're the ones that are dialing. So the answer is yes, but I also don't want to make more of it than our normal course of business, looking for ways that we can add or enhance to our business.
Joe Pantginis -- H.C. Wainwright -- Analyst
Got it. Thank you, Brian.
Operator
Your next question comes from Jason McCarthy with Maxim Group. Your line is now open.
Jason McCarthy -- Maxim Group -- Analyst
Hey, Brian, thanks for taking the questions. Two questions, and specific around VAC2 and one more broadly. But for VAC2, can you give us a sense of when we could see the Cancer Research U.K. phase one data in lung? Is that going to be this year? And how is that data going to be used to present to regulators for development in the U.S.? And my second question is more broadly, you had mentioned the Vertex ViaCyte acquisition.
But can you talk just a little bit about what we see is essentially most big pharmas and big biotech are now aligned or aligning themselves with cell therapy non-oncology initiatives?
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
So question one is like itself a two-parter when VAC2 and then how would we use it. So I'll do Part 1. So it's up to Cancer Research U.K. and I'll just be very direct that one of the factors that led us to exercising our option to bring that program back was that we felt that it would move quicker in lineages hands than where it was.
So we don't know when that data will be available or published or presented. It's not our decision and it's not under our control. But when it does become available, we certainly will want to share it with everyone. And then, I'll hand off to Gary for how the information that we have collected can be useful to a U.S. filing.
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Yes. So one thing to keep in mind is that the endpoints, as he's shown on clintrials.gov are primarily safety at 5 years and signs of immune effector efficacy at two years. The last patient came on in February of this year. So that patient will take two years until February of 2024.
So we've got a ways to go for that patient, hopefully, because they continue to do well. We have the complete annual safety update. There are no untoward unexpected adverse events or serious adverse events, it's behaved as expected. Everything has been mild and well tolerated.
And so, those safety data will contribute to our regulatory submissions and discussions with the agency. And again, we're focused on the FDA, but there are other regulatory bodies that we'd like to essentially consider as well.
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
And then returning back to your second question. This is a really exciting time in cell therapy because I think what we're seeing, and it would be a debated point. But my view of what we're seeing is that as data continues to be generated, the most promising data in my mind is emerging in the area of differentiated cell types going after areas like Type 1 diabetes and Parkinson's. It's not with the undifferentiated "Adult cells", the mesenchymal cells from adipose or umbilical cell.
I think what's exciting in the seat that I sit in at Lineage and is shared with some of the companies that you have in mind when you're asking this question, are these non-oncology, so i.e., non-T cell non NK cell. Specific differentiated cell types that are used much like a bone marrow transplant. You are just manufacturing the cell type. The cell has a specific function.
You deliver it, you have to have a solution for how it can remain durable and not be rejected. But if the cells are there and they're functional, they may be able to provide that normal natural biological function that is somehow lost under certain conditions like dry-AMD with GA or Parkinson's disease or diabetes. And I agree with you entirely that it seems that more and more interest is being reflected by the international big pharma community, and they are sometimes making baby steps, sometimes making massive bites, but there does seem to be a trend in this direction, which I think is incredibly exciting because it is still a relatively early technology and early technologies get better with time. And so, I think you're going to see explosive growth in this field.
I've been saying that for a couple of years. And I think there's increasingly evidence to support that. And it will just be a question of how high is the ceiling on this. And I believe it's very high indeed.
Jason McCarthy -- Maxim Group -- Analyst
Great. Thank you for taking my questions.
Operator
[Operator signoff]
Duration: 0 minutes
Call participants:
Ioana Hone -- Head of Investor Relations
Brian Culley -- Chief Executive Officer and Interim Chief Financial Officer
William Wood -- B. Riley Securities -- Analyst
Gary Hogge -- Senior Vice President of Clinical and Medical Affairs
Rick Miller -- Cantor Fitzgerald -- Analyst
Joe Pantginis -- H.C. Wainwright -- Analyst
Jason McCarthy -- Maxim Group -- Analyst
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NEWS -- Oncolytics Biotech® Reports Second Quarter 2022 Financial Results and Recent Operational Highlights
NEWS -- NightHawk Biosciences Provides Second Quarter 2022 Business Update
DURHAM, N.C., Aug. 10, 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 second quarter ended June 30, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We continue to advance our evolution towards becoming a fully-integrated biopharmaceutical company via our subsidiary ecosystem. Specifically, we are on track to open the Scorpion San Antonio biologics manufacturing facility in Q3 and are actively progressing development efforts for our newly-announced commercial scale biomanufacturing facility in Manhattan, Kansas. We intend to provide a full suite of CDMO manufacturing and bioanalytic services to biopharmaceutical clients. I’m pleased to report that feedback from prospective customers has been positive, and we look forward to commercial announcements in the near-term.”
“On the clinical front, we continue to evaluate a variety of strategic options for our HS-110 and PTX-35 programs moving forward. Our Elusys subsidiary recently executed a contract to deliver ANTHIM® to Canada’s National Emergency Strategic Stockpile, our first sale of ANTHIM® outside the United States. Finally, we continue to advance our research efforts and expand our pipeline through ongoing development at our Skunkworx subsidiary. Overall, we are extremely encouraged by the outlook for the business and look forward to providing further updates on our growing pipeline and commercial activities.”
Second Quarter 2022 Financial Results
NEWS -- FuelPositive Announces Launch of Pre-Sales
TORONTO, Aug. 10, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce it is accepting pre-sale orders for its onsite, containerized green ammonia production systems, starting today. A new web page has been launched (https://www.fuelpositive.com/pre-sales/), providing an explanation of what to expect and a dedicated email address to start the sales process. Initial customers are expected to be farmers, who will use the Company’s production systems to manufacture green ammonia on their farms. The green ammonia will be used as fertilizer and ultimately to power farm machinery, such as tractors and other farm vehicles, generators and grain drying systems.
“We consider opening for pre-sale orders to be an important step in our commercialization strategy. Pre-sales order volume is an accurate indicator of demand. Demand will drive a lot of our decisions, including our sales and operational planning, our near-term material and labour plans, and our long-term manufacturing capacity planning. Our production schedule and detailed order fulfillment plans will also be influenced by the volume of pre-sales,” said Ian Clifford, FuelPositive CEO and Board Chair.
The Company’s sales approach will be consultative. Interested farmers will use the dedicated email address on the pre-sales webpage to express interest in FuelPositive’s onsite, containerized green ammonia production system. An introductory call will be scheduled to discuss their application, objectives and conditions on their farm. FuelPositive will tailor a proposal to individual farm requirements. This will provide the customer with an appreciation of what is required of them to produce their own green ammonia with the FuelPositive system. The customer will then have an opportunity to enter into a pre-sales agreement, and provide a nominal deposit, to secure a position in the production line-up. A series of subsequent calls will focus on developing a detailed plan to coordinate production of the system and prepare the farm for installation. At that point, a sales agreement will be considered to formalize the order.
Support for Farmers
“FuelPositive is investing in the development of an infrastructure to accelerate the adoption of our technology. Adopting our technology, sooner rather than later, will provide the benefits of supply chain independence for farmers at a time when they really need it. And the bonus is that more systems in the field will mean fewer carbon emissions associated with the production of ammonia,” said Derek Boudreau, Strategic Advisor of Agricultural Implementation, FuelPositive.
Some of the initiatives FuelPositive is working on include speaking with various levels of government to capitalize on clean tech adoption programs including accelerating depreciation and other tax incentives. These programs dramatically improve farmers’ return on investment timeframes. The Company is also forming strategic partnerships with financial institutions to help them understand the nature of the new technology to get them ready to help farmers finance their system purchases.
In addition, FuelPositive is working on the development of an international standard of accreditation and guidelines for using green ammonia. These standards will have significant impact on the value of carbon credits around the world and will also help farmers to influence local governments to reward the use of green ammonia in their operations.
“What matters here is that we consider our customers as our partners,” said Boudreau. “We understand that our systems can bring transformational change to farmers. We are committed to working together to make it happen as easily and as soon as possible.”
First Pre-Sales Customer
Tracy and Curtis Hiebert, FuelPositive’s partners in its first demonstration system pilot project are being considered as the first pre-sales customer. They have committed to purchase a commercial system after the successful completion of the pilot project on their Manitoba crop farm. Being able to produce ammonia on their farm eliminates the need for the Hieberts to rely on the current undependable supply chain. “The FuelPositive system will give us stability. That’s what we like about it. It’s stabilizing the supply and stabilizing the price,” said Curtis Hiebert.
Base System
The base system will include a hydrogen separator, nitrogen extractor, ammonia converter, control system with remote monitoring capability, nominal ammonia storage, and basic installation package. Each customer will consider adding options and potential deductions from this base specification. The customization will include production system features, storage system design, installation and delivery.
Base System Specs
NEWS -- Tokens.com to Release Q2 2022 Results on August 15th, 2022
TORONTO, August 08, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it will announce its financial results for the three and six months ended June 30, 2022 ("Q2 2022") on August 15th.
An investor call hosted by CEO Andrew Kiguel has been scheduled to discuss the Company’s Q2 2022 financial results starting at 10:00 am ET on Tuesday, August 16th, 2022.
Date: August 16th, 2022
Time: 10:00 a.m. ET
Dial-In: 866-455-3403
PIN: 83349366#
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of Metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at 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/20220808005092/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 to Release Q2 2022 Results on August 15th, 2022
TORONTO, August 08, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it will announce its financial results for the three and six months ended June 30, 2022 ("Q2 2022") on August 15th.
An investor call hosted by CEO Andrew Kiguel has been scheduled to discuss the Company’s Q2 2022 financial results starting at 10:00 am ET on Tuesday, August 16th, 2022.
Date: August 16th, 2022
Time: 10:00 a.m. ET
Dial-In: 866-455-3403
PIN: 83349366#
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of Metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at 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/20220808005092/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 -- FuelPositive Announces Advisor of Global Food Security and Partnership with University of Guelph
TORONTO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce it has signed an agreement with Lenore Newman of the University of Fraser Valley, naming her FuelPositive’s Global Food Security Advisor. The Director of the Food and Agriculture Institute at the University of the Fraser Valley, she is a leading researcher, author and past Canada Research Chair in Food Security. Dr. Newman researches agricultural land use policy, agricultural technology and bioengineering in the global food system.
The Company has also formed a partnership with the Controlled Environment Systems Research Facility at the University of Guelph. The research facility’s work is focused on “controlled environment agriculture”, which includes greenhouses and vertical farming where plants are grown indoors. Because of damage caused by climate change and the precariousness of traditional farming, many sustainable farming experts believe controlled environment agriculture will play a key role in feeding the billions of people on the planet in the coming decades.
Both appointments will be discussed in more detail at a live Corporate Update Webinar that FuelPositive is holding on Tuesday, August 9, 2022, at 2 p.m. ET, to provide stakeholders with a corporate update and answer questions.
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 11, 2022
CARLSBAD, Calif., August 04, 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 second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second 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 (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 6448886. 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 August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 1/2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, which is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005025/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- FuelPositive Announces Start of Validation, Pre-Sales and Selling Price in Preparation for Demonstration Project Launch
TORONTO, Aug. 04, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce it has begun validation of its onsite, containerized green ammonia production system, and on August 10, 2022, will begin accepting pre-sales. Additional critical milestones have been met in preparation for the launch of the Company’s first demonstration pilot project – including the hiring of key Operations team members and a move to the Company’s new lab/manufacturing facility.
“We are moving along quickly towards getting our first demonstration system onto the farm, and we’ve been realizing the tremendous benefits of having such an experienced and dedicated team to get us there,” said Ian Clifford, FuelPositive CEO and Board Chair. “Our company is growing rapidly – only a year ago, we set the groundwork for a successful business, and we now have a robust team of experts, advisors, multiple premises, respected partners, a patent-pending technology on the verge of being fully validated, and pre-sales starting up. It’s extremely gratifying to be achieving these milestones, doing what we said we would do to make a huge contribution to food security and positive environmental change around the world.”
Validation of Key Systems
Validation has begun, ahead of schedule. The original plan was to perform the validation when the entire system was completed. This plan still holds, but FuelPositive has implemented a process in which each component is individually tested as it is ready, which will drastically reduce the time required for final validation.
“This approach to validation is one way we are managing the global supply chain delays that we’ve experienced,” said FuelPositive Chief Operating Officer Nelson Leite. “Some of the parts and materials we have ordered are taking longer to get to us than estimated. With each delay, we assess the circumstances and determine how we can mitigate it, not only for the current demonstration system but to ensure we are prepared when we roll out more of our systems in the future. Mitigation strategies have included switching to new suppliers, validating at the supplier’s facility before shipping, buying off-the-shelf products that we modify, and increasing our staff sooner than planned so we can take on more of the work ourselves.”
“As a result, we are planning for validation to be fully completed by us in November 2022, rather than by late summer as we previously estimated. We are now saying “fall” 2022. After that, the two independent, third-party validations will follow quickly and at that point, we can move the system to the farm,” said Leite.
“I want to stress that our technology has progressed as planned, without any setbacks. These delays are associated with supply chain issues only. For instance, getting stainless steel for housings and flanges has changed from delivery in two days last November to 14 weeks today. This is just the way of the world right now, but we are experts at mitigating these kinds of circumstances and that’s why our timing is not being significantly affected,” added Leite.
Pre-Sales and Selling Price
“We have set our initial base price at CA$950,000 and expect the actual customer price to vary, as we customize the system to meet the particular requirements of each farm,” said Derek Boudreau, FuelPositive’s Strategic Advisor on Agricultural Implementation. “We arrived at that initial selling price after a great deal of research. The initial pricing will allow us to gain some momentum on deliveries to farmers, and once we realize scale efficiencies and move to serial manufacturing, our profitability will grow accordingly, while offering farmers savings compared to buying grey ammonia. The return on investment and payback period will vary according to the situation for each farmer. We will help them optimize that.”
To enter into a pre-sale arrangement, interested farmers will use a dedicated email address that will be published, beginning August 10, 2022, on a new “Pre-Sales” page of the Company’s website. The Company will reach out to each farmer to understand their specific situation and requirements. Each farmer will receive an individualized proposal from FuelPositive. A deposit will secure the farmer’s place in line.
New Hires and Premises
The Company has made several key hires to build the team it needs to move into production mode as quickly as possible, in order to meet the high demand it expects.?
The move to the new lab and manufacturing premises at 99 Northland in Waterloo, Ontario has begun, giving the expanded team the necessary space to do its work for the next year. Batch manufacturing will begin there.
In addition, a real estate partner and a site have been identified for the building of the Company’s first commercial manufacturing facility, which will be purpose-built for FuelPositive by the partner. It will initially provide up to 140,000 square feet and is expected to be ready for use in late 2023. Ordering of equipment for that site and designing of the robotics will begin when the new building breaks ground.
Webinar Registration
FuelPositive will hold a live webinar on Tuesday, August 9, 2022, at 2 p.m. ET, to provide stakeholders with a corporate update and answer questions.
NEWS -- CytoSorb® Becomes a Featured Blood Purification Therapy on Fresenius Medical Care Critical Care Platforms
BAD HOMBURG V.D. HÖHE, GERMANY and PRINCETON, N.J., Aug. 2, 2022 /PRNewswire/ -- Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME) and CytoSorbents Corporation (NASDAQ: CTSO) have expanded their partnership by establishing a multi-stage global collaboration to combat life-threatening diseases in critical care for an initial term of three years. The new agreement provides for the combined marketing and promotion of CytoSorb® with Fresenius Medical Care's critical care products by Fresenius Medical Care's marketing organization worldwide, excluding the United States. Compared to the prior co-marketing agreement, this agreement increases the commitments from both parties and ensures an ongoing and consistent level of marketing and promotional activity specifically focused around CytoSorb, where Fresenius Medical Care will actively market and promote CytoSorb as the featured blood purification therapy for removal of cytokines, bilirubin, and myoglobin on its critical care platforms. Over the next three years, various Fresenius Medical Care-led in-person, virtual, social media, and web-based marketing programs and events will feature CytoSorb therapy and highlight the cooperation between the two companies in the field of critical care.
Fresenius Medical Care and CytoSorbents expand global marketing collaboration featuring CytoSorb
"As part of Fresenius Medical Care's commitment to providing our customers with leading solutions for their critical care patients, we are pleased to announce this new global collaboration with CytoSorbents," said Dr. Olaf Schermeier, CEO of Critical Care at Fresenius Medical Care. "With the ability to seamlessly integrate CytoSorb with our multiFiltratePRO acute dialysis platform that is routinely used throughout the world today, we have the opportunity to positively impact patient care for various life-threatening conditions such as sepsis, liver failure, trauma, lung injury, and many others."
Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents commented, "CytoSorb adds a powerful new dimension of blood purification to Fresenius Medical Care's critical care portfolio. It is specifically designed to reduce toxic levels of cytokines, bilirubin, and myoglobin that can lead to organ failure. The process is similar to hemodialysis, mastered by Fresenius Medical Care to treat kidney failure, which removes accumulated small to medium-sized, water-soluble molecules and toxins from the bloodstream. However, CytoSorb adds the ability to remove large molecules and toxins that are poorly removed by hemodialysis. Combined, the two therapies work together in a complementary manner to provide treatment for a broad range of conditions in the intensive care unit."
Dr. Steiner went on to highlight the importance of this collaboration stating, "Together with Fresenius Medical Care, we now have the ability to broadly and consistently communicate the benefits of CytoSorb therapy to customers throughout the world. In addition, it enables us to execute targeted marketing campaigns in collaboration with Fresenius Medical Care which will help to accelerate the introduction and adoption of CytoSorb. Overall, I believe this will be the starting point for further exciting developments on both the medical and business fronts."
Mr. Chris Cramer, Vice President of Business Development at CytoSorbents commented, "We are excited to expand our relationship with our long-standing partner, Fresenius Medical Care. This agreement promotes a stronger collaboration with Fresenius Medical Care's global commercial organization to more effectively bring our CytoSorb therapy to more customers around the world as a featured blood purification solution on Fresenius Medical Care's critical care platforms. We believe the synergy has the potential to create sustained and broader growth for both companies over time and is just the first of multiple opportunities to offer our combined critical care solutions."
In addition to strengthening and expanding the global marketing of CytoSorb, CytoSorbents and Fresenius Medical Care also plan to work together to bring new innovative solutions to the market. The agreement also includes the certification of compatibility between CytoSorb and Fresenius Medical Care's current critical care platforms. To help support the increased marketing and promotional efforts of the expanded collaboration, CytoSorbents has agreed to subsidize a portion of the marketing costs through a royalty payment to Fresenius Medical Care based on CytoSorb sales in the intensive care unit on Fresenius Medical Care platforms, excluding the United States.
About Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME)
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.8 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,163 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 346,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the Company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
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 more than 70 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 body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $39.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the 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 and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, 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 contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management's current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
Contacts Fresenius Medical Care AG & Co. KGaA
Investor Relations:
Else-Kröner-Straße 1
61346 Bad Homburg
Germany
+49 (0) 6172 609-0
mailto://ir@fmc-ag.com
Contacts CytoSorbents Corp.
Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@cytosorbents.com
Public Relations Europe:
Marcus Schult
kommponisten
+49 69 13823 ext. 960
+49 172 4238938
mailto://marcus.schult@die-kommponisten.com
CytoSorbents Europe GmbH:
Josephine Kraus
PA by Dr. Christian Steiner
+49 30 765 84 66 23
mailto://josephine.kraus@cytosorbents.com
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SOURCE CytoSorbents Corporation; Fresenius Medical Care
NEWS -- Navidea Biopharmaceuticals Announces Publication of Study Examining Use of Tc99m Tilmanocept for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Melanoma and Oral Cancer in Australia
DUBLIN, Ohio, August 01, 2022--(BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia. The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.
Sentinel lymph node biopsy ("SLNB") is widely accepted as an important clinical step in staging cutaneous melanoma ("CM") and is also a validated procedure to stage the neck in oral cavity squamous cell carcinoma ("OCSCC"). Despite this widespread acceptance, several different radiocolloids and dyes have been used, resulting in a non-standardized method of localizing and retrieving sentinel lymph nodes. Tc99m tilmanocept (approved as "Lymphoseek" in the US, EU, and the United Kingdom; "Lymphoaim" in India) was developed to overcome limitations of radiocolloids (lack of specific binding sites in the lymph nodes, for example, resulting in higher than desired false negative rates in some studies) and acts by selectively targeting and binding CD206 receptors on the surface of macrophages and dendritic cells. The use of Tc99m tilmanocept as a radiopharmaceutical for SLNB in CM and OCSCC has not been studied in Australia to date. This prospective study had as its aim the investigation of Tc99m tilmanocept use to evaluate its application, suitability, and reliability in an Australian setting.
A total of thirty-five patients were included in this study (N=26 with CM; N=9 with OCSCC). Lymphoscintigraphy with Tc99m tilmanocept identified at least 1 SLN (sensitivity of 100%) in all patients. There was a 100% intraoperative retrieval rate of SLNs in all patients, with positive nodes found in 20% of patients. Tc99m tilmanocept also demonstrated high tissue specificity (100%), with lymph nodal tissue confirmed histologically, with no false positives.
This is the first study to evaluate the use of Tc99m tilmanocept in the Australian setting, adding to a growing list of studies worldwide, and further supports that Tc99m tilmanocept is a reliable radiotracer for assessing the nodal status in patients with CM and OCSCC.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted to see the continued exploration of the utility of Lymphoseek for sentinel node biopsy in solid tumors. This study provides further support that Lymphoseek can provide high sensitivity and specificity for detection of sentinel nodes and supports our continued expansion of Lymphoseek outside of North America."
Dr. Abdul-Razak said, "This first-of-its-kind study in the Australian setting provides additional evidence that Tc99m tilmanocept based lymphoscintigraphy is both a feasible and an accurate method for assessing nodal status in patients with CM and OCSCC. Furthermore, our study adds to the growing body of literature supporting its use for these indications."
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/20220801005761/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Reminds Investors of Today’s Deadline to be a Shareholder of Record for the Previously Announced Rights Offering
To be a shareholder of record, investors are advised to own Navidea Biopharmaceuticals stock by 4:00 PM ET, Monday, August 1, 2022 to account for T+2 settlement timing
Record date established as Wednesday, August 3, 2022
DUBLIN, Ohio, August 01, 2022--(BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today issued a reminder to shareholders that the record date of its proposed rights offering is Wednesday, August 3, 2022 ("Record Date"). To be a shareholder of record on the Record Date, ownership of Navidea stock must occur by market close on Monday, August 1, 2022 to account for settlement. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.
The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.
The expected calendar for the rights offering is as follows:
NEWS -- Plus Therapeutics to Present Data from Ongoing ReSPECT™ Clinical Trials at the Annual Conference on CNS Clinical Trials and Brain Metastases
AUSTIN, Texas, July 28, 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 for recurrent glioblastoma and leptomeningeal metastases at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases, co-sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO), being held August 12-13, 2022 in Toronto, Canada.
Details of oral presentation:
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Thursday, August 11, 2022, at 8:30 a.m. ET
SAN DIEGO, CA and CALGARY, AB, July 27, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Thursday, August 11, 2022, at 8:30 a.m. ET to discuss a corporate update and financial results for the second quarter of 2022.
Conference Call & Webcast
Date: Thursday, August 11, 2022
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 220-8474
Dial In – International: (647) 484-0475
Conference ID (if needed): 8806-576
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) 203-1112 (North America) or (647) 436-0148 (International) and using replay code: 8806-576#.
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
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SOURCE Oncolytics Biotech® Inc.
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NEWS -- Plus Therapeutics to Present at Inaugural Targeted Radiopharmaceuticals Summit
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 Norman LaFrance, M.D., Chief Medical Officer and SVP will give a presentation on the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), and share updates on the U.S. ReSPECT clinical trials at the inaugural Targeted Radiopharmaceuticals Summit, organized by Hanson Wade, being held July 26-28, 2022 at the Boston Park Plaza in Boston, Massachusetts.
Details of presentation:
Title: Radiolabeled NanoLiposomes: A Novel Targeted Treatment for Rare and Central Nervous System Cancers
Date: July 27, 2022 at 4:30 p.m. ET
Presenter: Norman LaFrance, M.D., Chief Medical Officer and SVP at 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 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Nanomix Announces Appoints Life Sciences Executive Thomas Schlumpberger as Chief Executive Officer and Member of the Board of Directors
SAN LEANDRO, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in mobile, affordable, point-of-care diagnostics, today announced the appointment of Dr. Thomas Schlumpberger as Chief Executive Officer and as a member of the Board of Directors, effective immediately. David Ludvigson, the Company’s previous Chief Executive Officer, will provide support through the transition and will serve as interim Chief Financial Officer. Mr. Ludvigson will continue to serve as a member of the Company’s Board of Directors and will serve as a senior business advisor to Nanomix.
Garrett Gruener, Chairman of the Board of Directors, stated, “We are excited to welcome Dr. Schlumpberger to the management team. His strong leadership will be invaluable as we work to establish our technology as a standard of care in point-of-care (POC) diagnostics. His breadth of experience in POC diagnostics will be instrumental as we accelerate the commercialization of the eLab system worldwide. The Company and Board of Directors would like to express our sincere gratitude to David Ludvigson for his contributions and leadership he provided Nanomix over the years. We have been preparing this transition for some time and look forward to Thomas’ leadership as we prepare for the next phase of our growth.”
Dr. Schlumpberger, commented, “I am thrilled and excited to join Nanomix. I truly believe the Nanomix eLab® system is the best POC diagnostic technology on the market today, which is why I chose to join the Nanomix management team. Nanomix’s quantitative and highly sensitive detection platform that performs a range of in vitro diagnostic assays, including but not limited to sepsis diagnosis and monitoring, has the potential to transform POC diagnostics. 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. We will be laser focused on sales and marketing activities, including building our global distribution network.”
Dr. Schlumpberger is a recognized expert in POC diagnostics and a seasoned senior executive with more than 20 years in the life sciences industry. His broad base of experience is directly applicable to the next phase of growth at Nanomix as the Company’s POC platform gains customer adoption. At Epocal, a POC company, he was responsible for international business and business development. He successfully launched a point-of-care product in India, Japan and Europe and, notably, he led the sale of Epocal to Alere. At Singulex, he concluded an investment from Grifols and successfully launched an ultra-high sensitivity assay in Europe. Most recently, as CEO of Pictor Limited, he successfully revamped the product portfolio and launched a COVID-19 antibody product successfully into several CLIA-certified laboratories. Dr. Schlumpberger has held senior executive roles with several other diagnostic companies, including Anixa, InVitae, Inivata, and Affymetrix. He received his Ph.D. in molecular and cell biology with distinction from the University of California, Berkeley.
“Over the past year and a half, we transformed our business from the development stage to a commercial operation,” said Mr. Ludvigson. “Dr. Schlumpberger has extensive experience in the POC industry and a proven track record of driving sales and global market adoption of diagnostic devices. Thomas’ skill sets will be invaluable as the Company moves forward, focused on the commercial rollout of the eLab system. I look forward to supporting Thomas in his leadership role.”
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanomix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections including sepsis. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
NEWS -- CytoSorbents to Report Second Quarter 2022 Operating and Financial Results
PRINCETON, N.J., July 25, 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, will report second quarter 2022 operating and financial results after the market close on August 2nd, 2022. CytoSorbents' management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.
Conference call details:
Date: Tuesday, August 2, 2022
Time: 4:30 p.m. Eastern
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
The live audio webcast and presentation can be accessed via the following link: https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations portion of the company's website at https://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
U.S. Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@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 -- Navidea Biopharmaceuticals Announces Publication of Study Examining Tc99m Tilmanocept Imaging of Arterial Inflammation in People with HIV
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the publication of a manuscript titled “Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach,” based on work performed at the Massachusetts General Hospital (“MGH”) and Harvard Medical School, Boston MA, and sponsored by the Company. The research, appearing in The Journal of Infectious Diseases (PMID: 35856671), was led by Principal Investigator Steven Grinspoon, MD, Chief of the Metabolism Unit at Mass General Hospital and Professor of Medicine at Harvard Medical School.
Persistent immune activation and downstream macrophage-specific arterial infiltration are thought to contribute to increased atherosclerotic (plaque) cardiovascular disease risk among people with HIV on anti-retroviral therapy (“ART”). In this study, Tc99m tilmanocept imaging was applied to investigate macrophage-specific arterial inflammation among participants with versus matched participants without HIV. The hypothesis was that people with HIV would demonstrate higher levels of aortic arterial inflammation in relation to atherosclerotic plaque and immune activation.
Results showed that patients with HIV on antiretroviral therapy (N=20) had significantly higher macrophage-specific arterial inflammation demonstrated by Tc99m tilmanocept than risk-matched people without HIV (N=10). Total, non-calcified, and calcified aortic plaque volume calculated from CT scans did not differ significantly between groups. Macrophage-specific arterial inflammation related to non-calcified plaque among HIV patients (and not among participants without HIV) and additionally related to levels of specific inflammatory markers. Aortic Tc99m-tilmanocept uptake was significantly higher across different uptake thresholds among participants with HIV (P=0.03) and demonstrated a steeper relationship between arterial inflammation and non-calcified plaque volume (P=0.0001 for interaction between HIV-status and plaque volume) but not calcified plaque volume (P=0.83 for interaction). Among people with HIV (and not among participants without HIV), non-calcified aortic plaque volume related directly with aortic Tc99m-tilmanocept uptake at different uptake thresholds.
Macrophage-specific arterial inflammation, quantified using a novel molecular imaging approach, was higher among patients with HIV on ART compared to matched participants of similar atherosclerotic cardiovascular risk without HIV. Arterial inflammation related to non-calcified plaque volume only among patients with HIV. Cellular biomarkers of inflammation also related to macrophage-specific arterial inflammation. These key immune pathways may contribute to heightened cardiovascular disease risk among people with HIV and are thus of relevance to identifying novel therapies.
These data suggest increased macrophage-specific arterial inflammation of noncalcified plaque may be a mechanism of increased cardiovascular risk in people with HIV. Use of Tc99m tilmanocept imaging may help to identify future targets for novel immunomodulatory therapies to reduce atherosclerotic cardiovascular disease risk among people with HIV on ART.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are pleased to have helped sponsor this important work with Dr. Grinspoon at MGH. This is another in a line of research collaborations we have had with the highest level of researchers at top tier institutions.” Dr. Rosol continued, “Today’s announcement exemplifies the broad reach of our tilmanocept platform. The development of applications of Tc99m tilmanocept as a biomarker in people with HIV could have far-reaching implications for monitoring patient treatment and making decisions about therapeutic benefit.”
Dr. Grinspoon said, “This study provides another key piece of evidence of increased arterial inflammation in relationship to monocyte and activation and key innate immune activation pathways in people living with HIV. Tilmanocept may be useful to assess novel immunomodulatory strategies to reduce inflammation and improve risk of cardiovascular disease in PWH.”
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/20220725005209/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Plus Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
To view entire financials follow link here: https://finance.yahoo.com/news/plus-therapeutics-reports-second-quarter-200500920.html
NEWS -- Nanomix Announces Distribution Agreement for the eLab System with Biotron Ltd. in Israel
SAN LEANDRO, Calif., July 21, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has entered into a distribution agreement with Biotron Ltd. (“Biotron”), an Israeli medical diagnostics distributor. Biotron will market and distribute the Nanomix eLab® system in Israel including the Nanomix S1 Panel cartridge and future new product cartridges for the eLab system.
John Hardesky, Chief Commercial Officer, stated, “Israel is widely known for healthcare innovation and we are proud to partner with Biotron to jointly bring our solution into this important market. Improving sepsis patient outcomes is a global initiative and the Nanomix eLab® system provides timely, mobile and accurate diagnostic results to support the critical need of earlier patient diagnosis.”
Aviram Aziel, Managing Director of Biotron, commented, “Biotron is very excited to launch the eLab system in Israel. This is major step forward to help doctors and their patients have the fastest, accurate results to help in the fight against critical infections and sepsis.”
Sepsis is a recognized global health crisis. Early identification and treatment is a need and a challenge for healthcare professionals around the globe. For many reasons, sepsis can be difficult to identify and is frequently under-diagnosed in the earliest stages. It affects as many as 50 million people every year, leading to approximately 11 million deaths annually.
The Nanomix eLab® system is a mobile, hand-held immunoassay and chemistry diagnostic system designed for the needs of rapid point-of-care testing. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. 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 as well as the rapid identification of current and prior SARS-CoV-2 infection. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit https://www.nano.com.
About Biotron Ltd.
Biotron Ltd. provides laboratory diagnostics and services in Israel with a strategic focus on unique and innovative diagnostic products that improve outcomes for hospitals and patients. Biotron is active in the Israeli market in various medical diagnostic fields and supports customers within the national public healthcare laboratories in government hospitals and private labs, as well as universities and research institutes.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Natalya Rudman
Crescendo Communications, LLC
Email: mailto://NNMX@crescendo-ir.com
Tel: (212) 671-1020 Ext.304
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NEWS -- Navidea Biopharmaceuticals Informs Stockholders of Key Dates and Terms Related to Announced Rights Offering
DUBLIN, Ohio, July 20, 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 provided an informational update to stockholders regarding its proposed rights offering and the expected key dates and terms relative to the offering. Stockholders of record on August 3, 2022 (the "Record Date") will be entitled to participate in the rights offering. Prospective stockholders who wish to participate in the rights offering are advised to ensure that they complete their open market purchases of Navidea’s common stock by August 1, 2022 to be considered a stockholder of record on the Record Date. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.
Stockholders, warrant holders, preferred holders or interested parties are advised to direct all questions and informational requests to the contacts listed below.
Under the rights offering, Navidea will distribute one non-transferable subscription right for each one (1) share of common stock, each one (1) warrant and each one (1) share of preferred stock (on an as-if-converted-to-common-stock basis) held on the Record Date. Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.75 per share) and one (1) warrant to purchase 1,333 shares of Navidea’s common stock with an exercise price of $0.80 per share. The warrants will be exercisable for 5 years after the date of issuance.
The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.
The expected calendar for the rights offering is as follows:
NEWS -- Tokens.com Announces Completion of Strategic Investment Round at Hulk Labs
TORONTO, Ontario, July 19, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that its subsidiary, Hulk Labs, has completed a strategic financing round led by DV Investment Management.
Hulk Labs is a Tokens.com subsidiary focused on developing the emerging play-to earn Web3 gaming sector. This funding is the first time Hulk Labs has raised capital outside of Tokens.com. Tokens.com is participating in the financing round as the largest investor and will continue to own over 90% of Hulk Labs. The financing capital will be used to invest in yield-generating play-to-earn assets and to build out its existing gaming teams.
"Tokens.com is consciously working on building its businesses, and investing in the newest and most exciting areas of web3," commented Andrew Kiguel, CEO of Tokens.com. "Despite short term market turmoil, we are committed to using our capital to build high-growth Web3 businesses linked to long term macro opportunities such as play-to-earn gaming."
"We are excited to partner with DV Investment Management as we continue to grow Hulk Labs' play to earn business," said Deven Soni, President of Hulk Labs. "Despite the current market volatility, we continue to be incredibly bullish on the play-to-earn sector and continue to invest and build actively."
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About DV Group
DV Investment Management is an affiliate of the DV Group of financial services companies. Founded more than 15 years ago and headquartered in Chicago, the DV Group of financial services companies has grown to more than 350 people operating throughout North America and in Europe. Since spinning out of a large brokerage firm in 2016, DV Trading has rapidly scaled as an independent proprietary trading firm utilizing its own capital, trading strategies, and risk management methodologies to provide liquidity to worldwide financial markets and hedging opportunities to commodity producers and users. Now, DV Group affiliates include two broker-dealers, a cryptocurrency market making firm, and a bourgeoning investment adviser.
For further information, please visit: https://www.dvtrading.co/.
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/20220719005296/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Announces Completion of Strategic Investment Round at Hulk Labs
TORONTO, Ontario, July 19, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that its subsidiary, Hulk Labs, has completed a strategic financing round led by DV Investment Management.
Hulk Labs is a Tokens.com subsidiary focused on developing the emerging play-to earn Web3 gaming sector. This funding is the first time Hulk Labs has raised capital outside of Tokens.com. Tokens.com is participating in the financing round as the largest investor and will continue to own over 90% of Hulk Labs. The financing capital will be used to invest in yield-generating play-to-earn assets and to build out its existing gaming teams.
"Tokens.com is consciously working on building its businesses, and investing in the newest and most exciting areas of web3," commented Andrew Kiguel, CEO of Tokens.com. "Despite short term market turmoil, we are committed to using our capital to build high-growth Web3 businesses linked to long term macro opportunities such as play-to-earn gaming."
"We are excited to partner with DV Investment Management as we continue to grow Hulk Labs' play to earn business," said Deven Soni, President of Hulk Labs. "Despite the current market volatility, we continue to be incredibly bullish on the play-to-earn sector and continue to invest and build actively."
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About DV Group
DV Investment Management is an affiliate of the DV Group of financial services companies. Founded more than 15 years ago and headquartered in Chicago, the DV Group of financial services companies has grown to more than 350 people operating throughout North America and in Europe. Since spinning out of a large brokerage firm in 2016, DV Trading has rapidly scaled as an independent proprietary trading firm utilizing its own capital, trading strategies, and risk management methodologies to provide liquidity to worldwide financial markets and hedging opportunities to commodity producers and users. Now, DV Group affiliates include two broker-dealers, a cryptocurrency market making firm, and a bourgeoning investment adviser.
For further information, please visit: https://www.dvtrading.co/.
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/20220719005296/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 -- Provectus Biopharmaceuticals Establishes Research Collaboration with University of Nevada, Las Vegas to Investigate Small Molecule Immunotherapy Rose Bengal for Tissue Regeneration and Repair
KNOXVILLE, TN, July 19, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has initiated a new sponsored research program with Kelly Tseng, PhD, Associate Professor of Pathology and Lab Medicine, School of Life Sciences at the University of Nevada, Las Vegas (UNLV) to characterize the effects of Provectus’ pharmaceutical-grade rose bengal sodium (RBS) on vertebrate tissue regeneration and repair. RBS is the lead member of a class of small molecules called halogenated xanthenes that is entirely owned by Provectus.
The Tseng Lab at UNLV will assess the effects of RBS on animal development and tissue repair using the African clawed frog (Xenopus laevis), an established vertebrate model organism, and in vivo assays to evaluate key biological processes: embryo development, wound healing, and tissue regeneration.
Dr. Tseng is an expert in tissue regeneration and a leader in the regenerative biology and bioelectrical signaling fields. Her research group at UNLV seeks to elucidate the mechanisms of complex tissue regeneration in vertebrates using the highly regenerative clawed frog, with the goal of applying this knowledge to therapeutic strategies. Dr. Tseng has identified key factors that control limb and eye regeneration, and has also established a new model for studying embryonic eye stem cells.
She graduated from the Massachusetts Institute of Technology with a Bachelor of Science in Biology and Harvard University with a PhD, and was a Howard Hughes Medical Institute research fellow at Boston Children's Hospital. Dr. Tseng's work has been highlighted in books and media outlets including The New York Times.
Recent medical journal publications of hers include “From Cell Death to Regeneration: Rebuilding After Injury” (Front Cell Dev Biol 18;9:655048. 2021), “Studying in vivo Retinal Progenitor Cell Proliferation in Xenopus laevis” (Retinal Development. Methods in Molecular Biology, 2092:19-33. 2020), and “Using the Xenopus Developmental Eye Regrowth System to Distinguish the Role of Developmental Versus Regenerative Mechanisms” (Front Physiol 10:502. 2019).
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is RBS. A second HX molecule has been synthesized.
Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), animal health, and tissue regeneration and repair, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.
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 -- Tokens.com Announces Acquisition of Playte Group
TORONTO, July 14, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it has acquired Playte Group, a company that builds tools to power the play-to-earn (P2E) economy.
Playte will be integrated into Tokens.com subsidiary, Hulk Labs, where Playte’s platform will be used to manage its player network in Africa. In consideration of the acquisition, Tokens.com will issue 1 million shares. The Playte team is eligible for additional shares based on meeting various performance-based milestones.
"Hulk Labs is tying together the key pieces to create an integrated play-to-earn gaming platform," commented Andrew Kiguel, CEO of Tokens.com. "The massive video game market is shifting to play-to-earn games. Hulk is establishing itself as a technology leader in player management and in analyzing gaming profitability. Hulk labs currently provides the top gaming calculators for free on its website for players to view. The Playte acquisition is a perfect fit with our exclusive access to video game players in the DRC recently announced."
Playte is a pre-revenue entity domiciled in Ontario with 5 employees. Playte’s mission is to build a platform to automate the management of P2E assets and players in the blockchain play-to-earn ecosystem. In addition, Playte is building tools to manage players and assets for games on networks including Ethereum, Solana, and Avalanche. Playte is actively focused on building tools for games including Axie Infinity, Crabada, and Thetan Arena. In addition, the Playte team is in the process of building an on-the-ground network of 1,000+ players in Africa.
"We expect an explosion of interest in the play-to-earn economy from investors and gamers," said Deven Soni, COO of Tokens.com. "We are excited to work with the team from Playte to help build tools and infrastructure to grow this ecosystem."
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About Playte
Playte Group is a Ontario-based play-to-earn blockchain technology business that is building a set of software and tools to onboard, manage, and track players and assets in the play-to-earn economy.
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/20220714005321/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 Acquisition of Playte Group
TORONTO, July 14, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it has acquired Playte Group, a company that builds tools to power the play-to-earn (P2E) economy.
Playte will be integrated into Tokens.com subsidiary, Hulk Labs, where Playte’s platform will be used to manage its player network in Africa. In consideration of the acquisition, Tokens.com will issue 1 million shares. The Playte team is eligible for additional shares based on meeting various performance-based milestones.
"Hulk Labs is tying together the key pieces to create an integrated play-to-earn gaming platform," commented Andrew Kiguel, CEO of Tokens.com. "The massive video game market is shifting to play-to-earn games. Hulk is establishing itself as a technology leader in player management and in analyzing gaming profitability. Hulk labs currently provides the top gaming calculators for free on its website for players to view. The Playte acquisition is a perfect fit with our exclusive access to video game players in the DRC recently announced."
Playte is a pre-revenue entity domiciled in Ontario with 5 employees. Playte’s mission is to build a platform to automate the management of P2E assets and players in the blockchain play-to-earn ecosystem. In addition, Playte is building tools to manage players and assets for games on networks including Ethereum, Solana, and Avalanche. Playte is actively focused on building tools for games including Axie Infinity, Crabada, and Thetan Arena. In addition, the Playte team is in the process of building an on-the-ground network of 1,000+ players in Africa.
"We expect an explosion of interest in the play-to-earn economy from investors and gamers," said Deven Soni, COO of Tokens.com. "We are excited to work with the team from Playte to help build tools and infrastructure to grow this ecosystem."
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About Playte
Playte Group is a Ontario-based play-to-earn blockchain technology business that is building a set of software and tools to onboard, manage, and track players and assets in the play-to-earn economy.
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/20220714005321/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 Appointment of New Chief Financial Officer
TORONTO, July 13, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, announces the appointment of Martin Bui as Chief Financial Officer effective August 1st, 2022.
Martin joins Tokens following his role at Hut 8 Mining Corp since 2019, where he led the financial reporting function, combined with both corporate and operational finance efforts. Martin brings experience in the tech and cryptocurrency space and the underlying Canadian and U.S. capital markets and compliance regimes.
"We are excited to welcome Martin to the Tokens.com team," said Andrew Kiguel, CEO. "Martin’s experience in the digital space is a valuable addition to our finance team."
"I am very excited to join the management team at Tokens.com, one of the leaders in the Metaverse and Web3 space," said Martin Bui. "I look forward to bringing my industry experience to the Company to build further value for our shareholders."
Ian Fodie will remain as a financial consultant and Corporate Secretary to the Company to ensure a smooth transition to Martin and to provide ongoing support.
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of Metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220713005800/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 Appointment of New Chief Financial Officer
TORONTO, July 13, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, announces the appointment of Martin Bui as Chief Financial Officer effective August 1st, 2022.
Martin joins Tokens following his role at Hut 8 Mining Corp since 2019, where he led the financial reporting function, combined with both corporate and operational finance efforts. Martin brings experience in the tech and cryptocurrency space and the underlying Canadian and U.S. capital markets and compliance regimes.
"We are excited to welcome Martin to the Tokens.com team," said Andrew Kiguel, CEO. "Martin’s experience in the digital space is a valuable addition to our finance team."
"I am very excited to join the management team at Tokens.com, one of the leaders in the Metaverse and Web3 space," said Martin Bui. "I look forward to bringing my industry experience to the Company to build further value for our shareholders."
Ian Fodie will remain as a financial consultant and Corporate Secretary to the Company to ensure a smooth transition to Martin and to provide ongoing support.
About Tokens.com
Tokens.com Corp is a publicly traded Web3 company that owns and invests in an inventory of Metaverse, NFT, DeFi, and gaming based digital assets. Tokens.com’s focus is to invest in and build Web3 businesses through its primary entity and subsidiaries. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at https://www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220713005800/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 to Announce Second Quarter 2022 Financial Results and Host Conference Call on July 21, 2022
AUSTIN, Texas, July 13, 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, announced that the Company will report second quarter 2022 financial results on Thursday, July, 21, 2022, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the 'For Investor' section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Successfully Completes Key Milestone for cGMP Manufacture of Lead Investigational Radiotherapeutic
Completes technology transfer and initiates cGMP manufacturing for critical Rhenium-186 NanoLiposome (186RNL) drug product intermediate
On track to manufacture cGMP materials to support ongoing and planned clinical trials for rare cancers in 2022 and beyond
AUSTIN, Texas, July 12, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it has reached a key milestone on the path to commercialization of Rhenium-186 NanoLiposome (186RNL) as the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions (PPS). Additionally, the intermediate drug product is in stability testing and compliant with U.S. Food and Drug Administration (FDA) guidance for manufacture of liposomal products for use in late-stage clinical trials and commercialization.
In early 2021, Plus Therapeutics entered into a master services agreement with PPS for the development, manufacture and supply of the Company’s 186RNL drug intermediate product and has now completed the associated technology transfer of analytical test methods and development activities with PPS.
“The Company has met another significant CMC milestone by having fully compliant 186RNL intermediate, and is on time and on budget to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and future disease targets,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “Furthermore, in the third quarter of 2022, we plan to issue specific guidance on feedback obtained from two FDA meetings, one based on potential acceptability of Plus Therapeutics’ CMC package and one for feedback on our future plans for clinical development of 186RNL for recurrent glioblastoma.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM or the ReSPECT-LM trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- The 2022 CytoSorb World Users' Meeting Highlights the Broad Market Potential of CytoSorb as an Interdisciplinary Therapeutic Approach
PRINCETON, N.J. and BERLIN, July 8, 2022 /PRNewswire/ -- During the recent 2022 CytoSorb Users' Meeting in Berlin, Germany hosted by CytoSorbents Corporation (NASDAQ: CTSO), leading critical care specialists, cardiac surgeons, and research scientists from around the world highlighted the use of CytoSorb® blood purification across a broad range of applications driven by major current trends in healthcare. Examples include diseases of the rapidly aging population such as sepsis and trauma, the high incidence and prevalence of chronic liver disease and acute liver failure, the growing global demand for solid organ transplants, the risk of bleeding caused by the widespread use of antithrombotic "blood thinning" medications, severe illness due to the COVID-19 pandemic, and many others.
CytoSorbents World Users' Meeting highlights expanding value of CytoSorb blood purification in critically ill patients
Nearly 300 specialists from 40 countries attended the conference in-person with leading KOLs presenting updates on the latest scientific findings, clinical study results, and data from new case series in an expansive agenda (seen here). These presentations underscore CytoSorb® as a pioneering, interdisciplinary therapeutic approach for organ support that both builds upon, and extends beyond, its first approved indication of cytokine reduction when launched in Europe ten years ago. Among the many notable speakers:
NEWS -- Navidea Biopharmaceuticals Announces Additional Bridge Loan Funding
DUBLIN, Ohio, July 05, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on July 1, 2022, its largest shareholder and Vice Chair of the Board of Directors, John K. Scott, Jr., funded an additional $1.0 million under the secured bridge loan that was executed on April 10, 2022.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted to have the continued funding in place from Mr. Scott to keep our Phase 3 and R&D efforts moving forward."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220705005312/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Leading Critical Care and Cardiac Surgery Specialists from 40 Countries Meet to Discuss CytoSorb and the New Dimension in Blood Purification
The 2022 CytoSorb World Users' Meeting focuses on groundbreaking new applications of the adsorption technology to celebrate the 10th anniversary of commercialization
PRINCETON, N.J. and BERLIN, July 1, 2022 /PRNewswire/ -- Under the theme "We Are Changing Medicine: CytoSorb Therapy - From the Past to the Future," CytoSorbents Corporation (NASDAQ: CTSO) is bringing together nearly 300 of the world's leading critical care physicians and renowned scientists, as well as some of the most experienced cardiovascular and liver specialists to the 2022 CytoSorb World Users' Meeting (WUM) on July 2, 2022 in Berlin, Germany. Together, they will discuss updates on the latest scientific findings, study results, and case series using CytoSorb blood purification in different clinical applications.
The kick-off and one of many highlights will be the keynote speech by Prof. Dr. Bruno Reichart, the cardiothoracic surgeon who performed the first successful human heart-lung transplant in Germany in 1983. He will discuss lessons learned from the renaissance of xenotransplantation – the transplantation of non-human organs into human patients – which could someday help to end the global shortage and waiting lists for donated organs. Solid organ transplant (e.g. hearts, lungs, kidneys, and livers) is an exciting new field for CytoSorbents. This includes multiple cardiothoracic surgery applications of CytoSorb during and after heart-lung transplants, and includes the burgeoning field of ex vivo organ perfusion with our E.U. approved ECOS-300CY®/PerSorb® cartridge, with the goal of rehabilitating solid organs to improve clinical outcomes.
In recent years, the WUM has established itself as an inclusive and highly-anticipated interdisciplinary event with pioneers and power users from all over the world exchanging first-hand insights into clinical results and experiences with CytoSorb in various fields of application. A major focus of this year's discussion by top-level participants will be the combination of CytoSorb and ECMO to treat lung failure, the use of CytoSorb to reverse septic shock, and how CytoSorb is helping to advance the treatment of acute liver failure.
"The dialogue and partnership with CytoSorb users over the past 10 years has proven immensely informative and personally rewarding," said Christian Steiner, EVP Marketing & Sales of CytoSorbents and Managing Director of CytoSorbents Europe. "The combined energy and ideas from this working group has led to some of the most exciting advances in the treatment of life-threatening illnesses using our CytoSorb therapy. Users have embraced the new dimension of blood purification that CytoSorb has enabled. One powerful example is the treatment of cytokine storm that is at the core of so many deadly conditions. On this important anniversary event, we can all be proud that we are 'Working to Save Lives'."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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U.S. Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@cytosorbents.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
mailto://josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
kommponisten
+49 69 13823 ext. 960
+49 172 4238938
mailto://marcus.schult@die-kommponisten.com
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SOURCE CytoSorbents Corporation
NEWS -- Provectus Biopharmaceuticals Presents Data from PV-10® Treatment of Metastatic Uveal Melanoma Patients in Two Oral Presentations at 2022 International Society of Ocular Oncology (ISOO) Congress
KNOXVILLE, TN, June 30, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver (mUM) in its cancers-of-the-liver Phase 1 trial of investigational immunocatalyst PV-10 (NCT00986661) were part of two oral presentations at the 20th Congress of the International Society of Ocular Oncology (ISOO), held June 17-21, 2022 in Leiden, The Netherlands.
The first presentation, given by Krysta McVay, Research Nurse, Department of Melanoma Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center (MDACC), was entitled “A phase 1 study of percutaneous autolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases.” A copy of her presentation is available on Provectus’ website at: https://www.provectusbio.com/media/docs/publications/ISOO_PV-10_McVay-2022.pdf.
Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine and Director of the Uveal Melanoma Program at MDACC and Chair, Melanoma Committee, SWOG Cancer Research Network, made the second presentation entitled “Metabolic complete responses (mCR) in metastatic uveal melanoma (mUM) patients treated with image-guided injection of PV-10.” A copy of her presentation is available on the Company’s website at: https://www.provectusbio.com/media/docs/publications/ISOO_PV-10_mCR_Patel.ew16Jun22_v4.pdf.
This ongoing single-center mUM study at MDACC has been led since inception by Dr. Patel. Up to three hepatic mUM tumors can be injected per PV-10 treatment cycle. Response assessments are performed at Day 28, and then every three months. Patients with additional, injectable, visceral hepatic mUM disease may receive additional cycles of PV-10 after Day 28. Eligible patients may also receive standard of care immune checkpoint blockade during and after PV-10 treatment.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is RBS. A second HX molecule has been synthesized.
Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), and animal health, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of:
The Company’s Annual Report on Form 10-K for the period ended December 31, 2021, and
Provectus’ Quarterly Report on Form 10-Q for the period ended March 31, 2022.
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Tokens.com Announces Fireblocks as New Custodial Partner
TORONTO, June 30, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it has migrated the majority of its liquid staking assets to Fireblocks. The decision was made to take advantage of the strong internal administrative and reporting protocols available at Fireblocks, in addition to enhanced security features.
Fireblocks is a technology and security provider for institutional blockchain clients. Fireblocks has raised over $1 billion dollars from investors including Sequoia Capital and BNY Mellon and has 1,300 institutional clients. Alongside its security evaluations and improvements, Fireblocks also complies with rigorous international standards and completed a Service Organization Control (SOC) 2 Type II examination.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About Fireblocks
Fireblocks streamlines operations by bringing all your exchanges, OTCs, counterparties, hot wallets, and custodians into one platform. Wallets, deposit addresses, and API credentials are secured using patent-pending chip isolation technology and the newest breakthrough in cryptography (MPC).
For further information please visit https://www.fireblocks.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 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/20220630005100/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 Fireblocks as New Custodial Partner
TORONTO, June 30, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that it has migrated the majority of its liquid staking assets to Fireblocks. The decision was made to take advantage of the strong internal administrative and reporting protocols available at Fireblocks, in addition to enhanced security features.
Fireblocks is a technology and security provider for institutional blockchain clients. Fireblocks has raised over $1 billion dollars from investors including Sequoia Capital and BNY Mellon and has 1,300 institutional clients. Alongside its security evaluations and improvements, Fireblocks also complies with rigorous international standards and completed a Service Organization Control (SOC) 2 Type II examination.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.
About Hulk Labs
Hulk Labs is a Tokens.com subsidiary company that invests in the NFT ecosystem with a focus on play-to-earn games. The company acquires gaming tokens and NFTs and monetizes them through staking and gaming guilds.
For further information please visit https://www.hulklabs.com/.
About Fireblocks
Fireblocks streamlines operations by bringing all your exchanges, OTCs, counterparties, hot wallets, and custodians into one platform. Wallets, deposit addresses, and API credentials are secured using patent-pending chip isolation technology and the newest breakthrough in cryptography (MPC).
For further information please visit https://www.fireblocks.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 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/20220630005100/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