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NEWS -- Plus Therapeutics to Present at the 5th Targeted Radiopharmaceuticals Summit Europe
AUSTIN, Texas, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that Marc H. Hedrick, M.D., President and Chief Executive Officer, will deliver a presentation at the 5th Targeted Radiopharmaceuticals Summit Europe, being held December 5-7, 2023 in Berlin, Germany.
5th Annual Radiopharmaceuticals Summit Europe
Presentation Title: Re-186 Radiolabelled NanoLiposomes for Rare Brain and Spinal Cord Tumors
Date/Time: Wednesday, December 6, 2023 at 1:00 – 1:30pm CET
Session: Taking a Deep Dive into Novel Targets & Their Basics to Understand How They Affect TRP Development
Location: Berlin Marriott Hotel
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
Selling shares to raise 4 million dollars, someone is willing to pay 8 cents a share, sounds very good to me.
NEWS -- Theriva Biologics, Inc. (NYSE:TOVX) Q3 2023 Earnings Call Transcript
Operator: Greetings, and welcome to the Theriva Biologics, Inc. 2023 Third Quarter Operational Highlights and Financial Results. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Steve Shallcross. Thank you. You may begin.
Steve Shallcross: Thank you, Irene, and good morning, everyone, and thank you for joining our call today. Welcome to Theriva Biologics Third Quarter 2023 Investor Conference Call. Joining me on today's call will be Dr. Manel Cascallo, Director General of Theriva Biologics' European Subsidiary; and Dr. Vince Wacher, Head of Corporate and Product Development of Theriva Biologics. Theriva Biologics issued a press release this morning, which provided operational highlights and included the financial results for the third quarter ended September 30, 2023. The press release can be found in the Investors section of the company website at www.therivabio.com together with the quarterly report on Form 10-Q for the quarter ended September 30, 2023, which we plan to file today with the Securities and Exchange Commission.
A doctor consulting with a patient, discussing treatment options for breast cancer.
In addition to the phone line, this call is being streamed live via webcast, which will be archived on the company's website, https://www.therivabio.com for 90 days. During this call, certain forward-looking statements regarding Theriva Biologics and VCN Biosciences' current expectations and projections about future events will be made. Generally, the forward-looking statements can be identified by terminologies such as may, should, expects, anticipates, intends, plans, believes, estimates and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in Theriva Biologics filings with the SEC, many of which are difficult to predict.
No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information on this call is provided only as of the date of this call, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. With that, I'd like to start by discussing our progress during the quarter. In the third quarter of 2023, we continue to make steady progress to drive forward our oncology-focused portfolio designed to address unmet needs for difficult-to-treat cancers. With our extended cash runway into the first quarter of 2025, we believe we're well positioned to execute on our corporate objectives and remain on track to achieving multiple value-enhancing milestones.
Our primary efforts and resources are focused on pursuing multiple therapeutic opportunities for our lead clinical candidate, VCN-01. As a reminder, VCN-01 is a systemically administered oncolytic adenovirus designed to selectively replicate within the tumor, degreed to tumor matrix and increase tumor immunogenicity. We believe these multiple modes of action position VCN-01 for optimized tumor killing across several indications and in combination with different types of therapies. The potential use of VCN-01 to enable and enhance the use of chemotherapy and immuno-oncology products and otherwise refractory solid tumors is a strategic focus for Theriva that may provide multiple opportunities in areas of high therapeutic need. Today, I'm pleased to report recent highlights from our ongoing programs, evaluating VCN-01 in different indications in combination with chemotherapy, immune checkpoint inhibitors and CAR-T cells.
Building on our exploration of the potentially broad synergistic clinical benefit of VCN-01, we are pursuing new oncolytic virus candidates to leverage our novel Albumin Shield Technology, which is designed to protect systemically administered oncolytic viruses from the host immune system and may facilitate repeated administration of oncolytic virus therapies. This may enable our pipeline programs to be used in standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy. Additionally, as part of our oncology focused portfolio, we continue to screen and enroll patients in the second cohort of the Phase Ib/IIa clinical trial of SYN-004 designed to prevent potentially fatal adverse outcomes in patients who undergo allogeneic hematopoietic cell transplant, or HCT, to treat hematologic cancers.
With this brief introduction, I will now provide further details on how these programs continue to position Theriva the forefront of oncolytic virus development, starting with our lead program, VCN-01. Our confidence in VCN-01 is built on a strong clinical foundation as VCN-01 has been administered to more than 100 patients across diverse indications, including pancreatic ductal adenocarcinoma or PDAC, head and neck squamous cell carcinoma, colorectal cancer, ovarian cancer and retinoblastoma. VCN-01 has been granted orphan drug designation in the U.S. and Europe for the treatment of pancreatic cancer and in the U.S. for retinoblastoma, providing additional opportunities for regulatory engagement and if approved, market exclusivity. Our most advanced program for VCN-01 is in PDAC, which has one of the lowest survival rates among all cancers and is an indication that is ripe for innovation.
It is well established that the PDAC tumor matrix is one of the key reasons for the overall poor therapeutic outcomes for these patients. We believe VCN-01 has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access by co-administered cancer therapies. VIRAGE, our Phase IIb trial of VCN-01 in combination with standard of care chemotherapy, gemcitabine and nab-paclitaxel as a first-line therapy for patients with PDAC, continues to advance with dosing well underway across sites in the U.S. and Spain. VCN-01 has been well-tolerated with a safety profile consistent with prior clinical trials. We remain on track to complete enrollment with 92 available patients in the first half of 2024.
As a reminder, the primary endpoint for the trial include overall survival and VCN-01 safety and tolerability. Additional endpoints include progression-free survival, objective response rate and measures of VCN-01 biodistribution replication and immune response. Since this is an open-label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented and supported by emerging data. More broadly, the VIRAGE trial will enable us to determine the feasibility of repeated dosing of VCN-01, which could shift the paradigm to standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy and may lead to improved clinical outcomes for patients with PDAC and other solid tumors.
In addition to advancing the VIRAGE PDAC trial, we continue to work closely with key opinion leaders in the U.S., Europe, Central and South America to refine our clinical strategy in retinal blastoma. Since current clinical practice varies and there's no regulatory guidance specific to retinoblastoma drug development, we have submitted our meeting request with regulatory agencies and look forward to discussing the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. We believe intravitreal VCN-01 has the potential to treat Vitreous seeding in children with retinoblastoma, and we look forward to leveraging our orphan drug designation in this indication to facilitate protocol discussions with the FDA and other regulatory agencies to enable the development of new potential treatment options for this difficult-to-treat cancer.
In parallel with company-sponsored studies, the potential utility of VCN-01 is being explored in a number of investigator-sponsored studies that are underway at leading oncology research institutions around the world. Today, I'll focus on recent updates from our collaboration with the Catalan Institute of Oncology, or ICO, for patients with head and neck cancer and the University of Pennsylvania for patients with pancreatic and ovarian cancer. Data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent metastatic head and neck cancer were recently presented at the European Society for Medical Oncology Annual Congress, or ESMO. Results showed enhanced patient survival up to almost 4 years in one patient, which correlated with VCN-01 mediated increases in CPS score, a key determinant of outcomes with anti-PD-L1 checkpoint inhibitor therapies.
These data are remarkable, given these patients had all failed prior lines of anti-PD-L1 treatment. In addition to the presentation at ESMO, we hosted a virtual KOL event featuring Dr. Ricard Mesia of the ICO. In addition to reviewing key takeaways from the ESMO poster presentation, Dr. Mesia discussed the unmet medical needs in head and neck cancer, current treatment limitations and the therapeutic potential of VCN-01. Dr. Mesia also highlighted data from the ICO Phase I study showing that VCN-01-treated patients had improved responses to later lines of therapy. This is consistent with VCN-01's matrix degrading effect, which enables better access by the co-administered cancer therapies and the potential to elicit an extended antitumor immune response.
Consistent with these clinical data, a significant increase in the infiltration of tumors with anti-PD-L1 positive immune cells was observed, which statistically correlated with patient survival. Additionally, the University of Pennsylvania continues to enroll and treat patients in their Phase I investigator-sponsored study, administering VCN-01 with huCART-meso cells to patients with ovarian and pancreatic cancers. VCN-01 is designed to increase tumor immunogenicity and improve access by additional therapies such as huCART-meso cells. While cell-based immunotherapies have had limited efficacy against solid tumors to date, we are encouraged by the initial results, highlighting the feasibility of administering VCN-01 with huCART-meso cells. These preliminary results were recently presented at the Society for Immunotherapy of Cancer Annual Meeting or SITC.
With no dose-limiting toxicities observed to date, the study will continue to explore higher doses of VCN-01 co-administered with huCART-meso cells. We look forward to further data from the study to determine if VCN-01 can improve patient outcomes with these powerful immunotherapies to treat solid tumors. Turning to our ongoing Phase Ib/IIa clinical trial, Washington University evaluating SYN-004 ribaxamase to reduce potentially fatal adverse events related to IV beta-lactam antibiotic use in allogeneic HCT recipients, including acute graft versus host disease, or aGVHD, and overgrowth in infection by pathological organisms such as C. difficile and vancomycin-resistant enterococci. The Phase Ib/IIa study is designed to assess the feasibility of using VCN-04 and consists of 3 sequential cohorts comparing different IV beta-lactam antibiotics following conditioning therapy.
In each cohort, patients will receive SYN-004 and 4 will receive placebo. While the data remain blinded, interim analysis suggests that SYN-004 is well tolerated and was not observed in the blood samples of a majority of the available patients. Our second cohort is underway and is designed to evaluate SYN-004 in combination with piperacillin and tazobactam. This cohort will provide important additional safety information, in particular, whether oral SYN-004 has the potential to alter IV antibiotic levels in this patient population. Overall, we're encouraged by the progress across our pipeline and the growing clinical data that underscore the promise of our systemically administered oncolytic adenovirus in key indications and combinations. We remain focused on driving our clinical programs forward and exploring opportunities to leverage our novel Albumin Shield Technology and exciting additional technologies from our OV discovery platform.
I'm confident that the company's strong cash position and upcoming catalysts provide a solid foundation for execution and value creation. We remain on track to complete enrollment for VIRAGE in the first half of 2024, meet with the FDA to discuss the clinical program and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma before the end of the year and complete enrollment in the second cohort of our Phase Ib/IIa clinical study of SYN-004 for the prevention of aGVHD and bone marrow transplant patients in the first half of 2024. Now I'd like to briefly turn to our financial results for the third quarter ended September 30, 2023. General and administrative expenses decreased to $212,000 for the 3 months ended September 30, 2023, from $2.4 million for the 3 months ended September 30, 2022.
This decrease of 91% is primarily comprised of the decrease in the fair value of contingent consideration of $1.6 million, along with lower salary and bonus costs investor relation fees, audit fees, travel and VCN administrative expenses not included in the prior year, offset by an increase in consulting fees. The charge related to stock-based compensation expense was $95,000 for the 3 months ended September 30, 2023, compared to $93,000 for the 3 months ended September 30, 2022. Research and development expenses increased to $4 million for the 3 months ended September 30, 2023, from approximately $2.6 million for the 3 months ended September 30, 2022. This increase of 56% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase II clinical trial of VCN-01 in PDAC offset by decreased expenses related to our Phase Ib/IIa clinical trial of SYN-004 in allogeneic HCT recipients, Phase Ia clinical trial of SYN-020 and decreased manufacturing expenses related to our Phase Ia clinical trial of SYN-020.
We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase II clinical trial of VCN-01 in PDAC and our ongoing Phase I clinical trial in retinal blastoma, expand GMP manufacturing activities for VCN-01 and continue supporting our VCN-11 and other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $40,000 for the 3 months ended September 30, 2023, compared to $28,000 related to stock-based compensation expense for the 3 months ended September 30, 2022. Other income was $388,000 for the 3 months ended September 30, 2023, compared to other income of $161,000 for the 3 months ended September 30, 2022. Other income for the 3 months ended September 30, 2023, is primarily comprised of interest income of $382,000 and an exchange gain of $6,000.
Other income for the 3 months ended September 30, 2022, is primarily comprised of interest income of $170,000, offset by an exchange loss of $9,000. And a further strengthening of our balance sheet during the quarter ended September 30, 2023, we recognized a $1.4 million tax credit receivable and offsetting deferred R&D tax credit is a result of our participation in a research and development program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts that we incurred in Spain. As a condition for participation in the program, we will be required to maintain certain workforce levels in research and develop expenditures over the next 24-month period. Beginning in Q1 2024, the deferred R&D credit will be amortized monthly as a contra expense during 2024 and 2025.
We expect to receive the full cash payment under this program by the end of 2024. Cash and cash equivalents totaled $31.2 million as of September 30, 2023, compared to $41 million -- $41.8 million as of December 30, 2022. We remain deeply committed to improving patient outcomes through these very hard to treat cancers. And before we conclude today's call, I want to extend my sincere appreciation and gratitude for the foundational work that has brought us closer to developing and delivering on our mission. I'd like to thank the entire Theriva team, our investors and the many people who have been supportable along the way, including our patients and their families. With that, we're happy to take a few questions.
To continue reading the Q&A session, please click here.
NEWS -- NightHawk Biosciences Provides Q3 2023 Business Update
NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative therapies, today provided strategic, financial, and operational updates for the quarter ended September 30, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are very pleased with the progress of our Scorpius San Antonio facility where operations are advancing well and the feedback from our customers has been extremely positive. As a result, we are currently evaluating a variety of strategic options to maximize the potential of the business. We look forward to providing further updates on our efforts in the near future.”
Third Quarter 2023 Financial Results
NEWS -- Plus Therapeutics Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar
AUSTIN, Texas, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced positive data from the ongoing ReSPECT-GBM Phase 2 trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) at the Society for NeuroOncology (SNO) 28th Annual Meeting held November 15-19, 2023 in Vancouver, Canada. The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET. To register for the event, please click here.
“GBM needs better treatment options, and we are highly encouraged by the initial data from the NIH-supported ReSPECT-GBM Phase 2 trial of rhenium (186Re) obisbemeda in rGBM,” said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. “We believe the data presented at SNO suggests that rhenium (186Re) obisbemeda confers a survival benefit over published standard of care data and our own real world data assessments of propensity matched controls. Our 2024 focus will be onboarding additional clinical sites, completing Phase 2 enrollment, continuing the Phase 1 trial to maximum tolerated dose, and planning next steps for the program.”
“The interim ReSPECT-GBM Phase 2 data coupled with the novel imaging analyses reported at SNO further strengthens the compelling therapeutic rationale for the use of rhenium (186Re) obisbemeda on malignant gliomas,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. “The Phase 2 clinical outcomes thus far show effects consistent with the group of patients in the Phase 1 dose escalation trial that received both a therapeutic dose of radiation of greater than 100 Gy and tumor coverage of greater than 70%."
Key Highlights from the ReSPECT-GBM Phase 2 Trial
ReSPECT-GBM is an ongoing, first-in-human, open-label, Phase 1/2 study investigating dose escalation and other delivery parameters (i.e., number of catheters (1-5), infusion rates, drug volumes, and drug concentrations) to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and efficacy of rhenium (186Re) obisbemeda in recurrent adult glioma (IND 116117).
The primary objective of the Phase 2 study is to assess overall survival (OS) following rhenium (186Re) obisbemeda administration. As of November 14, 2023, 15 patients with rGBM have been treated with rhenium (186Re) obisbemeda at a dose of 22.3 mCi delivered directly to the tumor by Convection Enhanced Delivery (CED).
NEWS -- Cipher Neutron and FuelPositive Forge Strategic Partnership for Multiple AEM Electrolyser Technology Orders
WATERLOO, Ontario, Nov. 16, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) has placed its first purchase order with Canadian company Cipher Neutron Inc. (“Cipher Neutron” or “CN”) for its unique Anion Exchange Membrane (AEM) Electrolyser Technology.
Cipher Neutron’s Green Hydrogen AEM Electrolysers and Reversible Fuel Cell technology can produce hydrogen without using any Platinum Group Metals (PGMs), including Platinum, Iridium and Ruthenium. This makes CN AEM Electrolysers one of the most affordable and sustainable solutions available commercially to produce high-volume and high-pressure Green Hydrogen. Cipher Neutron Reversible Fuel Cells technology can be operated bi-directionally to generate electricity from hydrogen and hydrogen from water. Cipher Neutron Reversible Fuel Cells offer a compelling alternative to conventional storage options like batteries, eliminating the need for frequent recharging and reducing long-term maintenance expenses.
Cipher Neutron’s commercial technology, now available worldwide, is attracting interest from both strategic investors and end-users of the most efficient electrolysers in multi-Megawatt and Gigawatt projects across the globe.
FuelPositive is manufacturing modular, containerized Green Ammonia production systems, with its first commercial system, the FP-300, capable of producing 100 tonnes of Green Ammonia on-site, per year.
FuelPositive has selected CN AEM Green Hydrogen Electrolyser Technology as one of the most innovative and sustainable Green Hydrogen solutions in the world today. Upon successful testing and benchmarking by FuelPositive, the Cipher Neutron AEM Technology will be used to make Green Hydrogen to produce Green Ammonia in their commercial systems.
A FuelPositive FP300 system can produce up to 300 Kilograms of Green Ammonia per day, which requires 30 Normal Cubic Meters (Nm3) of hydrogen produced by the AEM electrolyser stacks. FuelPositive plans to manufacture thirty (30) FP300 systems over the next 12 to 18 months. FuelPositive’s integration of Cipher Neutron’s electrolysers for thirty (30) FP300 systems, would equate to 4.5 Megawatts of commercial deployment of AEM Electrolyser stacks.
Ian Clifford, FuelPositive’s Chief Executive Officer and Chair, stated, “We are very excited to work with Canadian Green Hydrogen innovator and manufacturer Cipher Neutron. FuelPositive is testing and benchmarking Green Hydrogen technologies worldwide for our systems. We were happily surprised to find out that one of the most promising and impressive Green Hydrogen technologies was here, right in our neighbourhood! Teaming up with Canadian technology companies and supporting the Canadian economy as we build our Green Ammonia solutions aligns with our mission as a Company. If everything works out as expected, we hope this is the first of many transactions with Cipher Neutron.”
Nelson Leite, Chief Operating Officer and Director of FuelPositive stated, “Cipher Neutrons AEM Green Hydrogen Electrolyser Technology has the potential to be an essential component in operating our FP300 systems and beyond. FuelPositive has built a world-class technology and manufacturing team, and this alliance positions the Company for accelerated growth. FuelPositive has successfully operated our core technology within our first pilot system.”
Gurjant Randhawa, M.Eng., P.Eng., President and CEO of Cipher Neutron, concluded, “Cipher Neutron supports FuelPositive in their commercialization of Green Ammonia. We are eager to work with FuelPositive toward successfully integrating our AEM Technology into their systems. Cipher Neutron and FuelPositive share an understanding of the imperatives around global food security and sustainability and a desire to make conscious choices toward a sustainable future in agriculture and other critical sectors. FuelPositive’s Green Ammonia system and business model stand alone, reframing the status quo of a multi-billion-dollar commodity industry. Cipher Neutron is excited to be part of this journey.”
About FuelPositive Corporation
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, FuelPositive aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
FuelPositive Corporation is based in Waterloo (Canada) and trades on the TSX Venture Exchange under the symbol NHHH and in the USA on the OTCQB under the symbol NHHHF.
About Cipher Neutron Inc.
Cipher Neutron is a rapidly growing disruptive technology company focused on AEM Electrolysers for Green Hydrogen production and Reversible Fuel Cells for power generation and Energy Storage Solutions. Cipher Neutron is a global group of scientists, engineers, technology developers, experts in hydrogen technology, investment bankers and people that have worked in hydrogen for decades. Cipher Neutron’s innovative products, such as AEM Electrolysers and Reversible Fuel Cells have unique advantages over other Green Hydrogen production, power generation and energy storage solutions currently available in the global market. Please see: https://cipherneutron.com
For further information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
Tel: 416.535.8395
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including with respect to further testing and implementation of the FP300 system, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
NEWS -- Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Advanced Cutaneous Melanoma
KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma (NCT02557321).
Initial results from CB-naïve patients in the main study cohort illustrated potential clinical benefit across all stages of metastasis. Longer-term follow-up of an expanded patient population has been assessed.
Participants must have had at least 1 injectable lesion and at least 1 measurable target lesion and been a candidate for pembrolizumab. The combination of PV-10 and pembrolizumab was administered every 3 weeks for up to 5 cycles, followed by pembrolizumab alone every 3 weeks for a total duration of up to 24 months. Patients may have received PV-10 as needed (PRN) beyond the initial treatment course per investigator discretion. The primary endpoint of the Phase 1b portion was safety and tolerability. Objective response rate (ORR) and progression-free survival (PFS) were key secondary endpoints (assessed via RECIST 1.1 after 15 weeks, and then every 12 weeks).
The addition of an expansion cohort balanced overall enrollment at 25 patients:
NEWS -- Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023
AUSTIN, Texas, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it will host a virtual KOL event on Monday, November 20, 2023 at 10:00 AM ET to discuss new Phase 2 ReSPECT-GBM data in recurrent glioblastoma presented at the Society for NeuroOncology (SNO) Conference. To register, click here.
The event will feature presentations from neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D. (UT Southwestern Medical Center, Peter O’Donnell Jr. Brain Institute) and John Floyd, M.D. (UT Health San Antonio, UT Health Medical Arts & Research Center), who will discuss the unmet need and current treatment landscape for patients with rGBM, the potential of rhenium (186Re) obisbemeda in rGBM, and key highlights from the new Phase 2 data presented at SNO.
A live question and answer session will follow the formal presentations.
About Andrew Brenner, M.D., Ph.D.
Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center Center at UT Health San Antonio, is a specialist in both breast cancer and malignancies of the brain and spinal cord. He not only focuses on clinical management, but also on the development of novel therapies to treat breast cancers and central nervous system tumors.
A graduate of Texas A&M University, he earned his bachelor’s degree in biochemistry and went on to earn his doctorate in biological science and tumor biology at The University of Texas M.D. Anderson Cancer Center – Science Park. His doctoral thesis focused on the role of the cyclin dependent kinase inhibitor p16INK4a in mammary tumorigenesis and immortilization. Dr. Brenner’s current interests have transitioned from cell cycle to the effect of hypoxia on chemokines and escape from antiangiogenics and the role of obesity in promoting breast tumorigenesis.
Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency in internal medicine at Scott and White Hospital in Lubbock. He completed his fellowship in hematology and medical oncology at the UT Health San Antonio.
About Toral Patel, M.D.
Toral Patel, M.D., is an Assistant Professor in UT Southwestern Medical Center’s nationally ranked Department of Neurological Surgery, where she specializes in brain tumor surgery.
Dr. Patel received her undergraduate degree in biomedical engineering from Johns Hopkins University and earned her medical degree at UT Southwestern Medical School. She completed an internship in general surgery at Yale-New Haven Hospital, followed by a residency in neurological surgery, serving as Chief Resident. She then received advanced training in neurosurgical oncology through a fellowship at Memorial Sloan Kettering Cancer Center before returning to UT Southwestern as a faculty member in 2014.
Dr. Patel’s research has garnered numerous awards, including the William F. Collins Resident Research Award, a Seed Grant from the American Medical Association, the UT Southwestern Medical Student Summer Research Award, the Louis E. Goodman Award, and the Johns Hopkins University Department of Biomedical Engineering Undergraduate Research Award. She currently holds a patent titled “Highly penetrative nanocarriers for treatment of CNS disease” for her research into how nanoparticles can be used to carry drugs directly to the site of brain tumors.
Dr. Patel is a member of the Society for Neuro-Oncology, the American Medical Association, the American College of Surgeons, the Congress of Neurological Surgeons, and the American Association of Neurological Surgeons.
She was included in D Magazine‘s Best Doctors list for 2018.
About John Floyd, M.D.
John Floyd, M.D., Professor of Neurosurgery and Otolaryngology, serves as the Chair of the Department of Neurosurgery and the Carl Raba Family Chair in Neuro-Oncology at the Long School of Medicine at UT Health San Antonio. He began his medical career in high school after obtaining early acceptance to the University of Alabama School of Medicine at the age of 18. Prior to matriculating, Dr. Floyd finished his undergraduate degree, graduating summa cum laude. He studied public health policy and clinical trial design at the University of Adelaide, South Australia on a rotary international scholarship.
Dr. Floyd’s surgical training began at the prestigious Vanderbilt University Medical Center in Nashville, Tennessee, where he completed an internship in general surgery. Subsequently, he finished his neurosurgical training from the department of neurological surgery at Vanderbilt University Medical Center. Dr. Floyd has also completed a fellowship in neurosurgical oncology and skull base surgery at the University of Texas M.D. Anderson Cancer Center.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.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 Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; 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; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, 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
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Theriva™ Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results
ROCKVILLE, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) — Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
“We are encouraged by the growing clinical data that underscores the promise of our systemically administered oncolytic adenovirus and lead program, VCN-01, in key indications and combinations,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) were recently presented at the annual ESMO Congress. Results showed enhanced patient survival, which correlated with VCN-01 mediated increases in the CPS (combined positive score for PD-L1 staining), a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies. Together with data presented at this year’s SITC meeting, these data further validate the feasibility of combining VCN-01 with immunotherapies.”
Mr. Shallcross continued, “We continue to advance VIRAGE, our Phase 2b trial of VCN-01 in newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), with patients dosed across sites in the U.S. and Spain. We have observed a consistent safety and tolerability profile and remain on track to complete enrollment for VIRAGE in the first half of 2024. As part of our commitment to transforming therapeutic approaches for devastating cancers, we will meet with the FDA before year-end to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. While our key area of focus is on advancing and maximizing the therapeutic potential of VCN-01, we continue to explore opportunities to bolster our pipeline with new oncolytic virus candidates from utilizing our Albumin Shield technology.”
Recent Program Highlights and Anticipated Milestones:
VCN-01:
NEWS -- Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Metastatic Uveal Melanoma
KNOXVILLE, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of uveal melanoma (UM) metastatic to the liver (mUM) (NCT00986661).
mUM patients enrolled in this study received 1 or more cycles of PV-10 injection into 1 or more hepatic metastases. Where indicated, standard of care immune checkpoint blockade (CB), as either monotherapy pembrolizumab or the combination of ipilimumab and nivolumab (IN), was also administered.
To date, 25 mUM patients have received monotherapy PV-10 or PV-10 in combination with CB:
NEWS -- Q3 2023 Lineage Cell Therapeutics Inc Earnings Call
Link to website: https://finance.yahoo.com/news/q3-2023-lineage-cell-therapeutics-141736405.html
NEWS -- Government of Canada Invites FuelPositive to Join Rebuild Ukraine Delegation
Paving the Way for Sustainable Agricultural and Energy Solutions
WATERLOO, Ontario, Nov. 09, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) is paving the way for sustainable agricultural and energy solutions as part of the select Canadian Delegation, at the Rebuild Ukraine Conference in Warsaw, Poland, from November 13th to 16th 2023.
This conference signifies an essential worldwide effort to support the people of Ukraine in rebuilding their nation.
Ukrainians have long played a vital role in feeding the world's growing population.
FuelPositive’s vision and commitment to global food security uniquely positions the Company to assist Ukrainian farmers in rebuilding their agricultural infrastructure.
FuelPositive's ground-breaking technology offers a game-changing solution. By decarbonizing and decentralizing ammonia production, FuelPositive can accelerate the creation of a more resilient and independent agricultural infrastructure. FuelPositive’s model of decentralized Green Ammonia production can offer more reliable cost and supply and provide Ukrainian farmers with the unique advantage of de-risking their operations.
Our innovative system enables farmers to produce Green Ammonia (NH3) onsite, eliminating the need for traditional, centralized, carbon-intensive sources of ammonia. By significantly reducing greenhouse gas emissions, our technology not only benefits the environment but also ensures a sustainable source of nitrogen fertilizer for the future.
Additionally, future FuelPositive advancements will allow farmers to use Green Ammonia as fuel for their equipment, further reducing their carbon footprint.
FuelPositive's Green Ammonia system comprises a nitrogen generator, a Green Hydrogen electrolyzer, and a patent-pending Green Ammonia synthesis converter. This advanced technology can operate using sustainable sources of electricity such as wind, solar, geothermal, or hydro, ensuring an environmentally friendly production process.
Ian Clifford, Board Chair and CEO of FuelPositive Corporation stated: "This Saturday, November 11th, is Remembrance Day in Canada, and the FuelPositive team would like to acknowledge everyone around the world affected by the devastation of war and offer solidarity toward peace and rebuilding efforts. FuelPositive would also like to extend its gratitude to the Government of Canada for including us in its ongoing support and investment in clean technology research, development, and adoption. Our Company is committed to supporting sustainable and independent agricultural practices worldwide. We look forward to collaborating with stakeholders and exploring partnerships in a peaceful Ukraine, driving positive change and helping Ukrainian farmers reassert their full potential as agricultural leaders."
For further information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
Tel: 416.535.8395
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including with respect to further testing and implementation of the FP300 system, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
NEWS -- Oncolytics Provides Update on Pancreatic Cancer Program for Pelareorep
Updated plan follows PanCAN's strategic re-evaluation of the Precision PromiseSM Program
PanCAN US$5 million grant provides support for new GOBLET mFOLFIRINOX arm to proceed as planned
New Phase 3 strategy provides significant value-creation opportunities
SAN DIEGO, CA and CALGARY, AB, Nov. 9, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, provided an update on the planned program for pelareorep in pancreatic ductal adenocarcinoma (PDAC).
Oncolytics' collaborator, The Pancreatic Cancer Action Network (PanCAN), a pancreatic cancer patient advocacy organization, advised the company that it is implementing a strategic re-evaluation of the Precision PromiseSM program and will not be adding any new investigational therapies to the platform until the re-evaluation is complete. Oncolytics and PanCAN had previously planned to initiate a Phase 3 trial using the Precision PromiseSM platform in H1 2024. Oncolytics now plans to conduct an adaptive Phase 3 program of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab, similar to the Precision Promise study and manage it directly within our Clinical Group and a contract research organization (CRO) with the goal of enrolling the first patient in mid-2024.
Additionally, Oncolytics and PanCAN confirmed that PanCAN will continue with its plans to grant US$5 million to Oncolytics as part of the Therapeutic Accelerator Award for the new Phase 2 GOBLET study arm evaluating the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) in pancreatic cancer patients.
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics, said, "Oncolytics remains steadfast in its commitment to initiate the Phase 3 program for pelareorep, starting in PDAC, in 2024. Having a compelling Phase 2 dataset in hand and strong connections with the pancreatic cancer community, Oncolytics is well positioned to effectively conduct the Phase 3 pancreatic cancer program. Trial preparations are actively underway, and we expect to initiate the enrollment of the first patient in mid-2024. The company plans to provide a further update on the design of the Phase 3 trial in H1 2024."
Dr. Coffey continued, "The opportunity to work with the strong scientific, regulatory and clinical leadership teams at PanCAN continues to be valuable for Oncolytics. We are grateful for our ongoing collaboration through the US$5 million Therapeutic Accelerator Award grant program in support of the new arm of the GOBLET study of pelareorep and mFOLFIRINOX, slated to begin in H1 2024."
"While we are undertaking a strategic re-evaluation of the program and are not adding any new therapies until the evaluation is complete, we remain committed to Oncolytics' efforts to accelerate therapies for pancreatic cancer patients through the US$5 million Therapeutic Accelerator Award Grant," said Julie Fleshman, President and CEO of PanCAN."
Dr. Coffey concluded by saying, "Looking ahead, we believe our updated plan to conduct the pelareorep Phase 3 pancreatic cancer program will enable us to be much closer to the conduct of the trial and the data. We believe this will be strategically valuable as we advance our partnering discussions and explore regulatory strategies to accelerate the development of pelareorep in order to bring this potentially important immunotherapeutic agent to people with cancer."
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our planned program for pelareorep in PDAC, including our plan to conduct an adaptive Phase 3 program managed directly within our clinical group and the anticipated benefits and timing thereof; our goals regarding the timing of enrollment in the study; our expectations regarding the US$5 million Therapeutic Accelerator Award from PanCAN and our planned usage thereof; our belief that we are well-positioned to effectively conduct the Phase 3 pancreatic cancer program; our plans for providing a further update on the design of the Phase 3 trial; our plans to advance partnering discussions and explore regulatory strategies to accelerate the development of pelareorep; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-provides-update-on-pancreatic-cancer-program-for-pelareorep-301983006.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- FuelPositive Ready to Accept 30% Deposits on 30 Initial Commercial Systems
WATERLOO, Ontario, Nov. 08, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) announces the completion of 3rd party verification of the FP300 Green Ammonia output rate. With this data in hand, the Company is now positioned to accept 30% deposits on the previously announced initial 30 commercial systems and ramp up its production. The base price of the FP300 Green Ammonia system is C$950,000.
Nelson Leite, COO and Board Member, commented, “With the 3rd party validated output rate completed, we can confirm our operating cost assumptions. This validation triggers the critical step of accepting 30% deposits from our lead customers for the initial 30 commercial systems.”
Ian Clifford, CEO and Board Chair, added, “This marks a transitional point in our evolution as a Company: shifting from a pre-revenue start-up to a revenue-producing commercial entity. 30% deposits on the initial 30 FP300 systems represents nearly C$9,000,000, with the completed sale of these systems representing approximately C$30,000,000. Additionally, we have hundreds of systems in our sales pipeline. It’s a very exciting time for all of us at FuelPositive and our stakeholders worldwide.”
Reza Esmailpour, P. Eng., at third-party process validation service M2AR Consulting of Cambridge, Ontario, stated: “We were impressed by the exceptional precision and meticulousness displayed by the FuelPositive team in their testing and data collection methods. Their system is truly notable, demonstrating a ground-breaking modular process of creating Green Ammonia. The validation period was highly successful. We look forward to further collaboration with FuelPositive in evaluating their subsequent processes and systems for the market.”
For additional information, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://ian@fuelpositive.com
Tel: 416.535.8395
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including with respect to further testing and implementation of the FP300 system, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.
NEWS -- Tokens.com Provides Corporate Update
TORONTO, November 08, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that builds immersive experiences and games in 3D internet environments and owns an inventory of cryptocurrencies, is pleased to provide a corporate update.
To better withstand current market conditions, the Company has streamlined its operations, including a reduction in staff of approximately 40% and the cancellation of certain outsourced services. Management estimates it has eliminated approximately CAD$1.6 million thus far from its operating overhead.
In addition, the Company and the board of directors (the "Board") have agreed to commence a strategic review of the business with a view to enhance shareholder and stakeholder value in the long term. Consideration is being given to a full or a partial sale of business segments or IP within those segments, a sale of the domain name portfolio, including Tokens.com, and/or a sale of the crypto inventory or other digital assets. An independent committee of the Board has been formed to review potential transactions.
Neither the Board nor the Committee have set a timetable to complete the strategic review process nor have any decisions been made relating to strategic alternatives at this time. There can be no assurance that the review process will result in a transaction. The Company does not intend to provide any updates or make any announcements unless or until it determines that further disclosure is appropriate or necessary.
Corporate Update and Strategic Direction Going Forward
Tokens.com has focused on building web3 projects and holding an inventory of crypto assets for staking. In 2021, our assets and share price appreciated significantly. However, since then, our asset values and share price have declined significantly as a result of several factors largely related to macroeconomic conditions and crypto prices. Management has attempted to offset these conditions through building new web3 businesses intended to bring in new revenue streams and new sources of growth.
While these initiatives have shown success, they will require additional capital commitment for further R&D and marketing. Given weak market conditions, there are no assurances that the Company will be able to access new capital in the future to scale these businesses.
At this time, the Company will scale back on further investments into its business segments in favour of preserving cash, while evaluating its next steps. The Company will maintain operation of its key businesses and crypto inventory, which largely remains staked and earning revenue.
"The last two years have been difficult for micro-cap stocks in the crypto sector. We have been successful in building innovative products and services for web3 for ourselves and third parties. However, these projects require continued capital for R&D and marketing to scale them successfully and cover their associated overhead," said Andrew Kiguel, CEO. "As a result, we have made the decision to reduce our operating overhead to preserve shareholder capital as the Company contemplates its next steps."
Part of management’s evaluation is exploring the sale of its domain name portfolio, including Tokens.com. Management believes that the Tokens.com domain name has tremendous value. CitiGPS predicts the tokenization of all physical and digital assets by the end of the decade is inevitable. As such, management believes that the opportunity to sell the domain name could provide substantial financial compensation to the Company. As a point of reference for its value, it is widely reported online that the domain name crypto.com was sold in 2018 between USD$10-12 million by Monaco, which subsequently rebranded as Crypto.com. NFTs.com is widely reported online to have sold for US$15 million in 2022.
Based on our last reported quarter, Tokens.com has approximately USD$12.2 million in cash and crypto tokens. Tokens.com expects to release its audited year-end result in mid-December 2023. Further information on our year-end audited results will be forthcoming in November 2023. The Company does not anticipate any issues completing its audit on time.
Tokens.com currently focuses on several operating segments, which are described fulsomely below. Through sharing resources and infrastructure across these business segments, Tokens.com is able to incubate these businesses from inception to revenue.
While the review process is ongoing, the Company’s management remains committed to executing on the Company’s strategy and business plan, including in the manner set out below.
Crypto Staking
The Company’s crypto staking segment involves the validation of blockchain transactions via a process called staking. In order to perform this task, a staker needs to own tokens of the asset it wishes to stake. In return, the staker is compensated with additional tokens of the underlying digital asset. We note, this is not a lending process and there is no counterparty risk. It is a process of validation using existing inventory similar to an electronic voting mechanism.
Since the end of 2021, this segment has been negatively impacted by declining crypto prices. To address this, the Company has narrowed the scope of its ownership of tokens to focus on larger names, primarily Ethereum.
Below is a table showing our current crypto ownership and corresponding value as of November 06, 2023.
Strategically, such assets underpin our valuation. We may strategically sell or buy more tokens in the future depending on our capital needs and market conditions. We note that a portion of our assets (denoted in the table above) are held with Genesis Global Trading that is undergoing a restructuring. As a result, some or all of those holdings may not be recovered.
Metaverse Group
Metaverse Group started as a business that purchased and rented out digital land in various metaverses. This business has evolved. As the hype cycle around the metaverse disappeared in 2022 and in 2023, the focus has shifted away from buying digital land and to providing third party clients with an ability to connect to consumers through 3D experiences. This includes the creation of customized games for clients. Today, Metaverse Group does not focus on web3, but instead on creating immersive experiences within web2 games like Roblox and Fortnite. This segment has been successful in attracting several high profile clients.
Since the June 2023 acquisition by the Company of the remaining interest in Metaverse Group which the Company did not own, management has been disappointed in its ability to generate revenue and scale. Revenues in this segment have also been affected by cuts in marketing budgets of potential clients. As a result, we have determined to downsize this business to a level that corresponds with its revenues.
Metaverse Group also owns US$1.56M in digital real estate in various metaverse platforms including Sandbox and Decentraland. While this digital land may have appreciation opportunities in the future, management is exploring the disposition of these digital assets.
Helix Worlds
Helix World is a proprietary ecommerce tool within Metaverse Group that will allow for product placement and advertising within virtual gaming worlds. The product has been in development for over a year and has recently launched.
The consumer ecommerce experience has not changed substantially in the last 20 years. However, with the advent and popularity of new 3D platforms such as Roblox and Fortnite, brands are seeking innovative ways to evolve their ecommerce solutions. Through Helix World, brands have the unprecedented opportunity to place their products into games and 3D environments without breaking the immersive experience. Helix World was innovated for brands to market their products to a new audience and for consumers to enjoy an improved shopping experience. Helix World is platform agnostic and will be available across multiple platforms and popular games such as Roblox and Fortnite.
Hulk Labs
Tokens.com’s video gaming initiatives reside within Hulk Labs. During the last 5 months, Hulk has pivoted from operating a player network in Africa, to developing a data platform called Yeti, that provides data services to the web3 gaming industry and the development of a web3 game called Astraeus Defense. While this may seem like a significant pivot, in reality, Hulk Labs utilized the IP it had already developed and repurposed to areas management feels have more upside.
In a recent report from Deloitte, 96% of Millenials, Gen Alpha and Gen Z located in the United States, play video games, regularly averaging 11-13 hours per week. Web3 gaming is growing rapidly in both the quality and number of games following $4.5 billion dollars invested in web3 games in 2022. Citi GPS estimates web3 gaming will surge up to 100 million players by 2025.
The average age of gamers is around 31 to 35 years old, with the most common age group being between 18 and 34, accounting for 38% of the gaming demographic. This points to the maturity and purchasing power of the average player?.
Going forward, Hulk will focus on the continued development and scaling of Yeti, a web3 gaming dashboard.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms. The Company also earns revenues through staking an inventory of owned cryptocurrencies.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centres, and 3D branded content, ii) web2 and web3 game development and game analytics, and iii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to the strategic review process and the work of the Committee; whether a strategic change, transaction or any outcome will result from or be consummated or implemented as a result of the strategic review process; and whether any transaction resulting from the strategic review process, if any, will ultimately enhance shareholder or stakeholder value in the long term.
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/20231108753201/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
NEWS -- Tokens.com Provides Corporate Update
TORONTO, November 08, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that builds immersive experiences and games in 3D internet environments and owns an inventory of cryptocurrencies, is pleased to provide a corporate update.
To better withstand current market conditions, the Company has streamlined its operations, including a reduction in staff of approximately 40% and the cancellation of certain outsourced services. Management estimates it has eliminated approximately CAD$1.6 million thus far from its operating overhead.
In addition, the Company and the board of directors (the "Board") have agreed to commence a strategic review of the business with a view to enhance shareholder and stakeholder value in the long term. Consideration is being given to a full or a partial sale of business segments or IP within those segments, a sale of the domain name portfolio, including Tokens.com, and/or a sale of the crypto inventory or other digital assets. An independent committee of the Board has been formed to review potential transactions.
Neither the Board nor the Committee have set a timetable to complete the strategic review process nor have any decisions been made relating to strategic alternatives at this time. There can be no assurance that the review process will result in a transaction. The Company does not intend to provide any updates or make any announcements unless or until it determines that further disclosure is appropriate or necessary.
Corporate Update and Strategic Direction Going Forward
Tokens.com has focused on building web3 projects and holding an inventory of crypto assets for staking. In 2021, our assets and share price appreciated significantly. However, since then, our asset values and share price have declined significantly as a result of several factors largely related to macroeconomic conditions and crypto prices. Management has attempted to offset these conditions through building new web3 businesses intended to bring in new revenue streams and new sources of growth.
While these initiatives have shown success, they will require additional capital commitment for further R&D and marketing. Given weak market conditions, there are no assurances that the Company will be able to access new capital in the future to scale these businesses.
At this time, the Company will scale back on further investments into its business segments in favour of preserving cash, while evaluating its next steps. The Company will maintain operation of its key businesses and crypto inventory, which largely remains staked and earning revenue.
"The last two years have been difficult for micro-cap stocks in the crypto sector. We have been successful in building innovative products and services for web3 for ourselves and third parties. However, these projects require continued capital for R&D and marketing to scale them successfully and cover their associated overhead," said Andrew Kiguel, CEO. "As a result, we have made the decision to reduce our operating overhead to preserve shareholder capital as the Company contemplates its next steps."
Part of management’s evaluation is exploring the sale of its domain name portfolio, including Tokens.com. Management believes that the Tokens.com domain name has tremendous value. CitiGPS predicts the tokenization of all physical and digital assets by the end of the decade is inevitable. As such, management believes that the opportunity to sell the domain name could provide substantial financial compensation to the Company. As a point of reference for its value, it is widely reported online that the domain name crypto.com was sold in 2018 between USD$10-12 million by Monaco, which subsequently rebranded as Crypto.com. NFTs.com is widely reported online to have sold for US$15 million in 2022.
Based on our last reported quarter, Tokens.com has approximately USD$12.2 million in cash and crypto tokens. Tokens.com expects to release its audited year-end result in mid-December 2023. Further information on our year-end audited results will be forthcoming in November 2023. The Company does not anticipate any issues completing its audit on time.
Tokens.com currently focuses on several operating segments, which are described fulsomely below. Through sharing resources and infrastructure across these business segments, Tokens.com is able to incubate these businesses from inception to revenue.
While the review process is ongoing, the Company’s management remains committed to executing on the Company’s strategy and business plan, including in the manner set out below.
Crypto Staking
The Company’s crypto staking segment involves the validation of blockchain transactions via a process called staking. In order to perform this task, a staker needs to own tokens of the asset it wishes to stake. In return, the staker is compensated with additional tokens of the underlying digital asset. We note, this is not a lending process and there is no counterparty risk. It is a process of validation using existing inventory similar to an electronic voting mechanism.
Since the end of 2021, this segment has been negatively impacted by declining crypto prices. To address this, the Company has narrowed the scope of its ownership of tokens to focus on larger names, primarily Ethereum.
Below is a table showing our current crypto ownership and corresponding value as of November 06, 2023.
Strategically, such assets underpin our valuation. We may strategically sell or buy more tokens in the future depending on our capital needs and market conditions. We note that a portion of our assets (denoted in the table above) are held with Genesis Global Trading that is undergoing a restructuring. As a result, some or all of those holdings may not be recovered.
Metaverse Group
Metaverse Group started as a business that purchased and rented out digital land in various metaverses. This business has evolved. As the hype cycle around the metaverse disappeared in 2022 and in 2023, the focus has shifted away from buying digital land and to providing third party clients with an ability to connect to consumers through 3D experiences. This includes the creation of customized games for clients. Today, Metaverse Group does not focus on web3, but instead on creating immersive experiences within web2 games like Roblox and Fortnite. This segment has been successful in attracting several high profile clients.
Since the June 2023 acquisition by the Company of the remaining interest in Metaverse Group which the Company did not own, management has been disappointed in its ability to generate revenue and scale. Revenues in this segment have also been affected by cuts in marketing budgets of potential clients. As a result, we have determined to downsize this business to a level that corresponds with its revenues.
Metaverse Group also owns US$1.56M in digital real estate in various metaverse platforms including Sandbox and Decentraland. While this digital land may have appreciation opportunities in the future, management is exploring the disposition of these digital assets.
Helix Worlds
Helix World is a proprietary ecommerce tool within Metaverse Group that will allow for product placement and advertising within virtual gaming worlds. The product has been in development for over a year and has recently launched.
The consumer ecommerce experience has not changed substantially in the last 20 years. However, with the advent and popularity of new 3D platforms such as Roblox and Fortnite, brands are seeking innovative ways to evolve their ecommerce solutions. Through Helix World, brands have the unprecedented opportunity to place their products into games and 3D environments without breaking the immersive experience. Helix World was innovated for brands to market their products to a new audience and for consumers to enjoy an improved shopping experience. Helix World is platform agnostic and will be available across multiple platforms and popular games such as Roblox and Fortnite.
Hulk Labs
Tokens.com’s video gaming initiatives reside within Hulk Labs. During the last 5 months, Hulk has pivoted from operating a player network in Africa, to developing a data platform called Yeti, that provides data services to the web3 gaming industry and the development of a web3 game called Astraeus Defense. While this may seem like a significant pivot, in reality, Hulk Labs utilized the IP it had already developed and repurposed to areas management feels have more upside.
In a recent report from Deloitte, 96% of Millenials, Gen Alpha and Gen Z located in the United States, play video games, regularly averaging 11-13 hours per week. Web3 gaming is growing rapidly in both the quality and number of games following $4.5 billion dollars invested in web3 games in 2022. Citi GPS estimates web3 gaming will surge up to 100 million players by 2025.
The average age of gamers is around 31 to 35 years old, with the most common age group being between 18 and 34, accounting for 38% of the gaming demographic. This points to the maturity and purchasing power of the average player?.
Going forward, Hulk will focus on the continued development and scaling of Yeti, a web3 gaming dashboard.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms. The Company also earns revenues through staking an inventory of owned cryptocurrencies.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centres, and 3D branded content, ii) web2 and web3 game development and game analytics, and iii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to the strategic review process and the work of the Committee; whether a strategic change, transaction or any outcome will result from or be consummated or implemented as a result of the strategic review process; and whether any transaction resulting from the strategic review process, if any, will ultimately enhance shareholder or stakeholder value in the long term.
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/20231108753201/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
NEWS -- Theriva Biologics to Host Conference Call and Webcast to Discuss Third Quarter 2023 Operational Highlights and Financial Results
ROCKVILLE, Md., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that it plans to host a conference call on Monday, November 13, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2023 and provide a corporate update.
Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13741546. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the “News & Media” section of the company’s website, https://www.therivabio.com, under “Events” or by clicking here, up to 90 days after the call.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics' website at https://www.therivabio.com.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
Source: Theriva Biologics, Inc.
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Preclinical PV-10 Vaccine Adjuvant Data at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting
KNOXVILLE, TN, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preclinical data from ongoing research on the potential use of investigational cancer immunotherapy PV-10 (rose bengal sodium) as an adjuvant in vaccines to help them work better was the subject of a poster presentation at the Society for Immunotherapy of Cancer (SITC) 2023 annual meeting, which was held in San Diego, CA from November 1-5. This research has been led by Aru Narendran, MD, PhD and his lab team from the Cumming School of Medicine at the University of Calgary in Alberta, Canada.
A copy of the SITC poster, titled “The iodinated fluorescein derivative PV-10 enhances the antiviral activity of CD8+ T-Cells by inducing STING dimerization: Implications for enhanced vaccine applications,” is available on Provectus’s website at https://www.provectusbio.com/media/docs/2023-SITC-poster.pdf.
Dr. Narendran and his colleagues previously discovered that PV-10 activated stimulator of interferon (IFN) genes (STING), demonstrating its potential as a vaccine adjuvant in PV-10-mediated systemic anti-tumor immune responses. See Thakur et al., American Association for Cancer Research 2020 Virtual Annual Meeting II.
In its SITC work, the Narendran lab showed that PV-10 treatment induced STING activation, upregulated cytokines and chemokines, and increased IFN-? secretion by CD8+ T-cells. Dr. Narendran and his colleagues demonstrated PV-10’s ability to function as an effective adjuvant to enhance T-cell responses and concluded that PV-10’s unique modulation of the STING pathway was a potential mechanism of this activity.
Dominic Rodrigues, Vice Chair of Provectus’s Board of Directors, said “This novel work introduces the potential of PV-10 to be an effective, multi-purpose, vaccine adjuvant for the first time, and conveys the opportunity to potentially use PV-10 in anti-viral, anti-cancer, and possibly other vaccines for greater protection against disease by improving a person’s immune response to vaccination.”
Mr. Rodrigues added, “We remain grateful to Dr. Narendran and his lab team members for their many-sided research to elucidate PV-10’s various potential mechanisms and applications. Provectus’s preclinical and clinical data to date, which may indicate that the response to PV-10 treatment is tantamount to in situ vaccination, may also suggest that PV-10-adjuvanted vaccines could potentially contribute to more effective and durable immune responses, better responses from patient populations with unique characteristics, higher efficacy using less antigen, and making vaccines more accessible, sustainable, and affordable.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, wound healing, and animal health; and in vitro drug discovery programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://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 -- Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to Rhenium (186Re) Obisbemeda for the Treatment of Breast Cancer with Leptomeningeal Metastases
AUSTIN, Texas, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to rhenium (186Re) obisbemeda for the treatment of breast cancer with leptomeningeal metastases (LM).
ODD status is granted by the FDA to an investigational drug or biological product intended to prevent, diagnose or treat a rare diseases or condition affecting fewer than 200,000 people in the United States. Companies granted ODD are eligible for certain benefits, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and 7 years of post-approval marketing exclusivity.
“Receiving Orphan Drug Designation from the FDA is important validation of our radiotherapeutic candidate for breast cancer patients with LM who currently have no FDA-approved treatment options,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “LM is a rapidly progressing and fatal complication of several cancers, including breast cancer, and incidence continues to rise. ODD status, together with the previously granted Fast Track designation, underscores the significant and urgent need for new treatment options for LM. We believe rhenium (186Re) obisbemeda has the potential to address this unmet need, and we look forward to continued progress of our ReSPECT-LM program.”
Rhenium (186Re) obisbemeda is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. Cohort 4 of the ReSPECT-LM trial recently completed enrollment, and the Company anticipates moving into Cohort 5 following standard safety review. Updates on the ReSPECT-LM trial will be presented at the Society for Neuro-Oncology Annual Meeting November 15-19, 2023. In addition to ODD, the FDA previously granted rhenium (186Re) obisbemeda Fast Track designation for the treatment of LM.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.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 Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; 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; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, 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
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Theriva™ Biologics and Sant Joan de Déu-Barcelona Children’s Hospital Advance Strategic Collaboration to Explore the Combination of VCN-01 with Topoisomerase Inhibitors to Treat Cancer
- Theriva signs exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors -
- Strengthens long-term research collaboration with SJD and builds on ongoing trial evaluating VCN-01 in pediatric cancers -
- Emphasizes VCN-01’s potential for use in diverse chemotherapy combinations and cancer indications -
ROCKVILLE, Md. and BARCELONA, Spain, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, and Sant Joan de Déu-Barcelona Children’s Hospital (“SJD”), a university hospital specializing in maternal, child and adolescent health care, today announced that Theriva has executed an exclusive worldwide option to negotiate an exclusive license certain SJD intellectual property rights related to the use of VCN-01 in combination with topoisomerase I inhibitor chemotherapies for the treatment of cancer. VCN-01 is Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus.
The collaboration builds on growing data that suggests coadministration of VCN-01 with topoisomerase I inhibitors such as topotecan can enhance VCN-01 replication and antitumor activity in preclinical cancer models. Combination of VCN-01 with a topoisomerase I inhibitor is expected to provide a synergistic antitumor effect wherein a chemotherapy-mediated increase in tumor VCN-01 levels may enable greater degradation of the tumor stroma, significantly increasing chemotherapy access and tumor destruction.
“This option with SJD reinforces our strategy of employing VCN-01’s unique modes-of-action to improve patient outcomes by enabling effective use of VCN-01 with different classes of chemotherapies and immunotherapies in otherwise refractory cancers,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Topoisomerase I inhibitors are used to treat a range of challenging tumors, including lung, cervical, colorectal, and pancreatic cancers as well as retinoblastoma. Recent findings suggest that the combination of VCN-01 and topoisomerase I inhibitors may provide a synergistic antitumor effect to improve therapeutic outcomes in these indications. SJD has been a valuable, long-term, research partner with Theriva, and we are very pleased to advance our collaboration with SJD to refine the technology and potentially advance a VCN-01 and topoisomerase I inhibitor combination into advanced clinical trials.”
Angel Carcaboso, Ph.D., senior group leader at SJD, commented, “The new treatment combination shows a powerful synergy in preclinical human cancer models, including intraocular and leptomeningeal retinoblastoma, Ewing sarcoma and neuroblastoma. Synergy happens through the effect of topotecan increasing the susceptibility of cancer cells to VCN-01 infection. The main goal of our work is to bring new treatments to children with catastrophic diseases, and our smooth partnership with Theriva facilitates the translation of our laboratory results to phase 1 trials.”
Theriva will pay SJD an option fee of twenty-five thousand Euros (€25,000). Final license terms will be negotiated during a 12-month option period.
About VCN-01
VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells, and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 90 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s wholly-owned Spanish subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. In addition to VCN-01, the Company’s clinical-stage candidates include: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
About Sant Joan de Déu – Barcelona Children’s Hospital
Sant Joan de Déu-Barcelona Children’s Hospital (SJD) is a university hospital specializing in maternal, child and adolescent health care. Founded in 1867, SJD belongs to the Hospitaller Order of Saint John of God and is a private, non-profit institution that has been integrated in the public network of the Spanish national health system since 1973. SJD is the largest children’s hospital in Spain and is one of the most recognized of its category across Europe. The hospital is accredited by the Spanish Ministry of Health as a reference centre for all Spain in a wide range of specialties such as Onco-haematology, Cardiology and Cardiac Surgery, Orthopedics, Neurosciences, Genetics, Rare Diseases, Ophthalmology and Reconstructive Surgery to name a few. The hospital is also accredited by the European Commission in 14 European Reference Networks for specialized care in rare diseases.
Associated with the University of Barcelona since 1994 and with the Hospital Clínic of Barcelona, a university adult hospital, SJD has a specialized pediatric research program managed by the Sant Joan de Déu Research Foundation. SJD together with the Hospital Clínic is one of the most well-known hospital alliances in Spain and an international reference for highly specialized hospital care, teaching and research. Thanks to numerous donors, on October 18, 2018 the hospital had the stone laying ceremony for the future SJD Pediatric Cancer Center Barcelona, which will be one of the largest pediatric oncology centers in Europe.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding data suggesting coadministration of VCN-01 with topoisomerase I inhibitors such as topotecan can enhance VCN-01 replication and antitumor activity in preclinical cancer models; the combination of VCN-01 with a topoisomerase I inhibitor providing a synergistic antitumor effect to improve therapeutic outcomes in these indications; a chemotherapy-mediated increase in tumor VCN-01 levels enabling greater degradation of the tumor stroma, significantly increasing chemotherapy access and tumor destruction; the Company’s work bringing new treatments to children with catastrophic diseases and SJD’s smooth partnership with the Company facilitating the translation of laboratory results to phase 1 trials. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, results of the research collaboration enhancing VCN-01 replication and antitumor activity in preclinical cancer models; the Company’s ability to complete enrollment in on-going and planned clinical trials when anticipated and anticipated results, the Company’s ability to address the unmet medical needs for treatment of PDAC and other refractory cancers, the Company’s ability to take advantage of the potential benefits of orphan drug designation, the Company’s ability to reach clinical milestones when anticipated, the Company’s ability to successfully operate the combined US and Spanish business entities, the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s ability to maintain license agreements, the continued maintenance and growth of the Company’s patent estate, the ability to continue to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript October 31, 2023
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors and considering such statements Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
A medical scientist holding up a test tube, illustrating biopharmaceutical research.
Marc Hedrick: Thank you, Tawanda. Good afternoon, everyone. Thank you once again for taking time to join us today as we provide an overview of recent business highlights and discuss our 2023 third quarter financial results. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer; and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call by reviewing our recent clinical and regulatory progress with a focus on the third quarter and then turn the call over to Andrew to review our financials. Dr. LaFrance will then be joining us for Q&A. I'll begin with updates on our two lead radiotherapeutic CNS cancer programs, starting with recurrent glioblastoma rGBM. Our ReSPECT-GBM trial of Rhenium-186 Obisbemeda in patients with GBM funded substantially by the [Technical Difficulty] it is to enroll as we work to add new sites in order to complete enrollment of the Phase II by the end of 2024.
In parallel to the active Phase II trial, the Phase I dose escalation trial continues to enroll. Assessing the effects of very high administered radiation doses in large volumes to bigger size tumors on radiation distribution, tumor coverage and safety. We presented an update on the ReSPECT-GBM trial at the Society for Neuro-Oncology ASCO meeting in August. To summarize the safety data, a single administration of Rhenium-186 Obisbemeda is generally well tolerated with no dose-limiting toxicities and minimal systemic radiation exposure across 34 GBM patients. In addition, no patients experienced treatment-related adverse events with the outcome of death and no patients withdrew due to AEs. Most AEs were mild or moderate in intensity and nonserious.
The maximum tolerated dose was not reached. With regard to efficacy, as we briefly discussed last quarter, we found that overall survival is highly correlated with absorbed dose and treated tumor volume. In the data set presented at SNO/ASCO, the median absorbed radiation dose to the tumor was 308 gray. When we look at the median overall survival in the Phase I trial through Cohort 6, for patients with absorbed doses less than 100 grey, median overall survival was 22 weeks or about five months. And in contrast for patients with absorbed doses greater than 100 gray, median overall survival was 70 weeks or almost 18 months. Applying the Cox proportional hazard statistical model, we have found that for each 100 gray increase in total absorbed dose, the risk of death decreased by 45.6% and for each 10% increase in the ratio of treated to total tumor volume, the risk of death decreased by 66.9%.
This data can be found in much greater detail on our website. In addition, we continue to assess data from the ongoing Phase II trial. New safety and efficacy data from the Phase II will be presented at SNO in November. Following the SNO meeting, we will be hosting a key opinion leader webinar of investigators to discuss the data in detail. This webinar will feature Neuro-Oncology expert, Dr. Andrew Brenner, who is a principal investigator on the trial and is presenting the data at SNO as well as others. We'll be sharing the details of this event soon and invite you to join us as we delve into the data with these experts more deeply. Now let me update you on our ReSPECT-LM Phase I/IIa dose escalation trial of Rhenium Obisbemeda for patients with leptomeningeal metastases or LM.
This is a trial that is substantially funded by the State of Texas through CPRIT. Following a successful FDA Type C meeting in Q3, we rapidly completed Cohort 4 in the LM trial. Cohort 4 is the first of four planned cohorts in Part B of the Phase I trial. Completing the dosing in Cohort 4 was the fastest enrollment of all the cohorts to-date and enthusiasm from sites to participate enroll patients remains high. Prior to our FDA meeting, we completed Part A of the Phase I trial, specifically cohorts one through three. This past August, we presented the results of these cohorts at the SNO/ASCO meeting and provided further explanation and context at the KOL roundtable event following the August meeting. In summary, for the first three cohorts, the data shows a favorable safety profile and no dose-limiting toxicities have been reached.
Pharmacokinetic analysis showed that the drug circulated rapidly throughout the CSF space and remained there for at least seven days following single administration. Using the CNSide tumor cell enumeration assay, we found that an average reduction of tumor cell counts at 28 days post-treatment of 53%. And finally, median overall survival was 10 months with five of 10 patients still alive. We also presented LM data at the CPRIT innovations in cancer [Technical Difficulty] in September. As mentioned, the ReSPECT-LM Phase I program continues to be funded in part by CPRIT through a three-year $17.6 million product development research funding award. In September, we received a planned $1.9 million advanced payment as part of the grant contract.
Andrew will discuss the forecasted grant revenue going forward for the next couple of years in a moment. Now I'll provide some further color on the CNSide assay used in our LM trial and the license agreement we negotiated for the assay in August. Taking a look at the big picture first. The diagnosis of LM and the monitoring of treatment response are notoriously difficult in LM even with our state-of-the-art imaging clinical evaluation and traditional cerebrospinal fluid evaluation. In contrast, the CNSide assay is highly specific and sensitive as a measure of CSF tumor cell enumeration that quantitates a number of tumor cells per mL of CSF. This technology represents a substantial improvement in assessing CSF tumor cells compared to the standard of care.
At Plus, although we are initially pretty skeptical of the value of the technology and use it as a potential secondary endpoint, our team has seen the value of the assay first-hand in our LM trial and to paraphrase one of our LM trial investigators, the CNSide assay is a "game changer" for LM disease diagnosis and monitoring. And therefore, it's obviously quite synergistic with our therapeutic approach. The company that developed the test Biocept, those has been in financial distress throughout 2023 and declared their insolvency earlier this month. I want to make it clear that the company's financial distress was not in any way based on the quality of the utility of the assay, but upon a variety of unrelated factors. However, prior to Biocept's announcement and because of this very concern, Plus successfully completed the transfer of all proprietary materials [Technical Difficulty] and equipment from Biocept to use the CNSide assay.
And now as per our plan, we're the test to no longer be commercially available to us, as it is not now, Plus can now begin CSF tumor cell enumeration testing limited to the ReSPECT-LM trial patients. Separately, we will consider whether to exercise the exclusivity option that we have which is exercisable through the end of 2024 under the current license. In the meantime, we'll monitor the insolvency proceedings closely. Now back to our LM trial. We plan to initiate dosing in Cohort 5 this quarter pending DSMB approval. In terms of next step for ReSPECT-LM, we will continue to focus on enrollment, site on-boarding, data assessment and planning for next steps, including Phase II. In terms of our pediatric trial, we continue to make steady progress in initiating our first in child pediatric brain cancer trial.
Travel initiation is behind our original schedule as the FDA has required substantially more supporting data from us, particularly from our ongoing trials. We had a positive follow-up meeting in Q3, and all FDA requests are both reasonable and satisfactorily addressable within the next quarter. Thereafter, pending IND clearance from the FDA anticipated to be in early 2024, we plan to initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with the ependymoma and high-grade glioma at Lurie Children's Hospital in Chicago. Our other novel radiotherapeutic Rhenium-188 nanoliposome biodegradable alginate microsphere or BAM for short continues to make regulatory development progress. As a reminder, BAM is a radioembolization compound designed to treat a variety of solid organ tumors.
We recently received feedback from the FDA regarding its regulatory designation and the BAM radioembolic product will be regulated as a device, primarily by CDRH. We view this as very good news as the clinical requirements and timeline for approval will be reduced in existing reimbursement paths are already in place. Our 2024 corporate goals for BAM will include specific guidance for development based on FDA -- the FDA regulatory decision. Now in terms of drug production, behind the scenes, we continue to expand and shore up existing supply agreements and work to build in across-the-board supply chain redundancy, including as it relates to isotope availability. As we complete new agreements or relationships, we will communicate those. And with that, I'll turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials.
Andrew?
Andrew Sims: Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the third quarter ended September 30, 2023. As of September 30, 2023, cash and cash equivalents were $11 million, which is in line with the balance at June 30, 2023. In addition, as of today, Plus has met the requirements to receive the next cash advance from CPRIT of $3.3 million, which we expect to receive prior to reporting our 2023 full year results. Plus also remains on track to receive additional advances in 2024, amounting to a further [Technical Difficulty] to a total of $10.2 million incremental non-dilutive cash grant funding is expected between today and December 31, 2024 from CPRIT.
In addition, the company continues to benefit from the 3 million grant from the NIH to support the GBM trial through Phase II, which is expected to be fully utilized by the end of 2024 to coincide with the completion of the ongoing Phase II trial. Based on the cash on hand and committed grant funding, our current balance sheet provides runway well into 2025. In addition, the company continues to be aggressive in the pursuit of additional NIH and separate grants to support both our current and planned future programs. Our practice will be to continue to announce those upon award. The company recognized $1.2 million of grant revenue in the third quarter of 2023 and $3.6 million year-to-date 2023. The company forecasts grant revenue of between $1 million to $1.5 million in Q4 2023 and between $6 million to $7 million for calendar year 2024.
Total operating expenses for the third quarter of 2023 decreased by $0.7 million to $4.5 million in 2023. Compared to total operating expenses of $5.2 million for the same period the prior year. The decrease is due primarily to the completion of the CGMP drug development in 2022. Other income totalling 32,000 for the quarter includes 119,000 of interest income, which fully offsets the interest expense on the remaining principal on the Oxford debt. So with the grant support our existing go-forward burn is close to 500,000 over the next 18 months. Net loss for the third quarter of 2023 was $3.2 million or $1 per share compared to a net loss of $5.2 million or $2.85 per share for the same period of the prior year. Now I'll turn it back to you Marc.
Marc Hedrick: Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on anticipated milestones over the next 14 months. First of all, in Q4, we have multiple presentations accepted at the SNO Annual Meeting, November 15 to 19 in Vancouver. We're particularly excited to present the first data cut from the ongoing Phase II GBM trial to be accompanied [Technical Difficlty] at our thought leader panel and we'll put out the specifics about that panel when finalized. Also the SNO annual meeting in November, we will also have an update on our LM trial as well. Looking beyond the SNO meeting and looking forward into 2024, we intend to complete enrollment in the Phase II ReSPECT-GBM trial and finalize a pivotal trial design with the FDA.
We also intend to complete enrollment in the Phase I ReSPECT-LM trial and begin the Phase II trial. We also intend to complete internal implementation of the CNSide cerebrospinal fluid tumor cell enumeration assay that has been currently utilized in the ReSPECT-LM clinical trial. We intend to obtain FDA IND approval and initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with ependymoma and high-grade glioma at the Lurie Children's Hospital in Chicago. We also will complete key development milestones for the company's next-generation radioembolic device, 188RNL-BAM. At a key second source, GMP supply chain partner to support late stage clinical trials of commercial supply and publish the ReSPECT-GBM Phase I data in a peer-reviewed publication.
Now with that I'll turn it back to Tawanda, the operator for our Q&A session.
Operator: Thank you. [Operator Instructions] Our first question comes from the line of Justin Walsh with Jones Trading. Your line is open.
Justin Walsh: Hi. Thanks for taking the questions and congrats on the progress. I’m wondering if you can provide any color on what we can expect from the presentations at SNO? I know you mentioned survival data for 15 patients, but if there’s any other info you can close ahead of the release and maybe remind us of how many patients’ worth of data we saw last time you guys presented?
Marc Hedrick: Hey, Justin, last time we presented data, there were 34 patients at a high level, 34 total patients treated in the trial. We have five abstracts accepted. Besides presenting the Phase II data set from a safety and efficacy perspective, one novel thing we’ll show is some pretty substantial updated imaging data, and that will be part of the presentation. So this will be across multiple presentations. I can’t really say any more than that as we continue to review the data. But one reason we’re having a thought leader panel is we’ll be able to bring a lot of that data that will be novel and put it into context with some of the investigators that are actually involved in patient care.
Justin Walsh: Great. Really looking forward to all that. So one more question for me. Obviously, there’s been some building momentum in the radiopharma field with M&A activity and some key data releases. Wondering if you’ve seen an increase in interest in your ongoing trials from perspective of patients, physicians and investors.
Marc Hedrick: Yes. So we’ve seen a lot of interest in our CNS radiotherapeutic assets. And I think there are several reasons for that. You mentioned one, which is there’s a renewed interest generally speaking, in the radiotherapeutic space. And Dr. LaFrance, who’s sitting with me today has been in the space for a while. And I think would tell you that it’s been a remarkable increase in interest over the last few years that he’s seen. The second thing is in the radiotherapeutic space, there’s a lot of work at preclinical. There are a number of very successful products and deals that have been announced. But there is a relative dearth of mid-stage assets. And I think that’s one reason we’ve seen a lot of interest in our technology and that we have an ongoing Phase II in GBM.
A very big indication and also LM, which is rapidly getting through the Phase I to Phase II. So that’s I think that’s created a lot of interest. And then finally, just the data itself. These are unmet medical needs that carry very high levels of mortality. There’s nothing approved for LM and there’s only been one approved drug for GBM in the last 10 years, which doesn’t improve survival. It just improves the symptomatology. So I think the combination of those three things has really created a lot of renewed interest in this space.
Justin Walsh: Great. Thanks for taking the questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Sean Lee with H.C. Wainwright. Your line is open.
Sean Lee: Good afternoon, guys, and thanks for taking my questions. First one, during the prepared remarks, you mentioned that the FDA requested additional info from both your existing studies and also for the upcoming pediatric study. Could you provide a bit more information on what was requested.
Marc Hedrick: Norman, would you like to take that?
Norman LaFrance: Hi, Sean. Thanks for the question. The FDA has always liked our approach for the dose escalation in pediatric tumors, which, as everyone knows, are not the same as adult tumors. And our plan is to do a dose escalation, not only an administered dose, but in volume. But as part of that, and as folks know FDA is very conservative, particularly around pediatric dosimetry and radiation treatment. As Marc has mentioned, we have a very well-established pulmonary database in the GBM adult trial. And what we did with FDA is review the adult dosimetry trial, review the adult safety data, which is very well tolerated and quite benign and pointing out to FDA that the — it will be an identical product administered in an identical way with the CED catheters has been quite a success story in adults.
When they got that information, they were very satisfied. We have an agreement to move forward in the protocol design and are just finishing up some minor clarifications with them, which we’ll do this quarter and to that point, we expect to start the pediatric trial early next year.
Sean Lee: Great. Thank you. That makes it much clearer. My second question is on the funding side. You mentioned that approximately $10 million additional for CPRIT next year as well, $3 million for NIH. Would that cover the majority of the expected Phase II study expenses for next year?
Andrew Sims: Thanks, Sean. So the short answer is yes. So separate funds, so let me just kind of give you a background of CPRIT then the timing. So CPRIT funds, two-thirds of all costs relating to the study. So which makes the grant extremely attractive, obviously. Currently, they cover effectively the majority of the third-party development costs, patient costs, drug costs, site initiation fees, et cetera, regulatory costs. And then they also cover significant internal costs, salaries and other overhead rent, IT, et cetera. And as we look forward and I kind of mentioned we would — we should receive over $10.2 million over the next 15 months that will cover just under 70% of the total costs.
Sean Lee: Great. My last question is just on the dose escalation study. I know previously you guys weren’t sure whether the current cohort will be the highest cohort. So I was wondering, would you go even higher in that study? And also what’s, remember, you guys also mentioned that you had a protocol for retreating patients. Is that also planned for a different cohort?
Marc Hedrick: Hi, Sean, it’s Marc. On the first question where we’ve got another couple of patients to complete 6 in cohort 8. We’re at very high radiation doses and volumes. And we’ll have to look at the data. But my guess is we won’t get to a maximum tolerated dose, but we very likely will get to a maximum feasible dose. And so data will be analyzed primarily for safety and distribution. So anyway that’s ongoing. As it relates to retreatment, so we’re in the process of putting a retreatment arm in all of our GBM sites with the idea that — and I don’t want to say too much and pre-empt some of the data at SNO. But we’re going to show imaging data that I think will be very interesting and we’ll can help provide a road map for achieving what is our primary corporate goal and that’s to turn CNS cancers into a chronic disease.
I will say that as it relates to the Phase II, if I can just editorialize a minute that I think we’re on track to complete the single administration Phase II by the end of 2024. If that data continues to look positive, we’ll present that data in the first pass of that at SNO. We may actually seek a pre-end of Phase II meeting with the FDA to discuss options for.
Sean Lee: Great. That’s all I have and thanks again for taking my questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Edward Woo with Ascendiant Capital. Your line is open.
Edward Woo: Yeah, congratulations on the progress. To clarify you said that Cohort 4 the LM trial was the fastest that you were able to get it filled. Is that something that you should expect going forward and does that speed up your time line at all with LM trial?
Norman LaFrance: Hi, Ed. This is Norman. Great question. And the — as I think we’ve discussed previously, there are protocol defined up [Technical Difficulty] that we agreed to with FDA because this is first-in-man intrathecal administration of, obviously, the radio activity. Given the interest that Marc alluded to earlier and a question on an earlier Q&A question, we’re getting a lot of interest on folks for the exact reason Marc mentioned that, first of all, there are really no treatments for this devastating complication. And there really are no significant active investigative trials other than ours. And we’ve gotten a very promising provocative efficacy signal in addition to being a very well-tolerated outpatient treatment.
So the short of it for the Cohorts now five through seven to be continued. We’d expect to enroll at the same rate. With that, we’d expect if there are no DLTs or other safety observations that may call the decision to end in an earlier Cohort, say, Cohort 6 will complete the full dose escalation probably by June of next year. With that, we’ll go to FDA and have an end of Phase I dose escalation and Pre-Phase II meeting and I don’t want to get too forward-looking. But given the current trend of both the safety, tolerability and preliminary efficacy will be in a position to talk to FDA about a Phase II trial that will include it being [Technical Difficulty] leading to an accelerated approval all because LM has no treatment options, is a devastating complication and not a lot of investigative.
At this point, I’ll stop there, and see if you have any other questions.
Edward Woo: Thank you very much. That was very helpful. I wish you guys good luck. Thank you.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.
Unidentified Analyst: Hi, guys. It’s Chad on for Jason. Sorry if it was already covered, but I was just wondering what the plans are for implementing CNSide in the LM study given that Biocept has declared bankruptcy, will you still be able to use the platform?
Marc Hedrick: Hi, Chad. Yes. So you’re right. They declared bankruptcy. We’ve been using the test for over a year and I did mention a bit in my prepared remarks, but I’ll expand on those. We didn’t really know what to expect. We started using the trial, the test, but over a year or so of experienced both with our technology and our trial and talking to the investigators, we think there’s a real opportunity with this test. We were concerned about them their solvency over the past year. And that’s why we, frankly, licensed and transferred the technology to ourselves in the weeks before they declared insolvency. So we essentially have a nonexclusive right to use the test for — in our trials with our technology and then we have an option that’s exercisable through the end of next year to gain exclusivity in the area of radiotherapeutics for this test.
So now that they’re gone, and they are gone, they’re no longer operating. We’ll be taking the protocols, the information and the testing kits that we have already acquired and are now in Texas and we’ll begin using the test, not in a CLIA fashion, but just as a research tool, so we can use in the context of our trial. Now with our option based on kind of our ongoing experience, we will actually consider whether we want to exercise that and maybe expand that. But right now, I think, the plan is just to implement it and use it in our trial and frankly CPRIT ought to pay for that as well.
Unidentified Analyst: Okay. Great. Thanks for taking the question and congrats on the progress.
Marc Hedrick: Okay. Thank you.
Operator: Thank you. I’m showing no further questions in the queue. I would now like to turn the call back over to Marc for closing remarks.
Marc Hedrick: Thank you, Tawanda. Thanks, everyone for joining us. Thanks for the good questions. Thanks for your interest in the company and we will be talking to you soon. Have a nice evening. Goodbye.
Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.
NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2023 Financial Results and Provide Business Update on November 9, 2023
CARLSBAD, Calif., November 01, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2023 financial and operating results on Thursday, November 9, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 9, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on November 9th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 17, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2323932.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231101272644/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- NHHHF: Green Ammonia Expected to Play Key Role in Many Sectors, Including Agriculture
Green Ammonia: use expected to rise as demand for sustainable solutions grows…
FuelPositive (OTCQB:NHHHF) (TSX.V:NHHH) is a Canadian-based production stage company preparing to commercialize Green Ammonia solutions and introduce a containerized production system that enables customers to produce Green Ammonia on their premises. On-site installation has the benefit of eliminating the negative environmental impact of distribution and also enables customers to produce Green Ammonia as needed. The company expects its system will also help customers smooth out ammonia pricing, which is critical for end customer markets, particularly given the company’s initial focus on small farmers.
Currently, the ammonia industry, which almost exclusively produces grey ammonia, is highly carbon-intensive. Traditional grey ammonia production leverages fossil fuels in the production process. By comparison, the company’s system utilizes water, air, and sustainable electricity to manufacture Green Ammonia in a way that mitigates or eliminates carbon emissions and is therefore sustainable. Specifically, the system leverages a nitrogen generator that produces nitrogen from air and a water electrolyzer that produces hydrogen from water and a patent-pending synthesis convertor that combines the nitrogen and hydrogen to produce ammonia. FuelPositive believes that its technology could position “green” ammonia as a fossil fuel replacement in multiple applications.
Moreover, by installing its system on a customer’s property near to where the Green Ammonia is to be used, the company also expects to eliminate the need to ship and store the ammonia. This has the dual benefit of eliminating the negative environmental impact of distribution and, as noted, also enables FuelPositive customers to produce ammonia as needed.
Certification on initial production …
FuelPositive has developed a Green Ammonia solution, engineering advanced electrolyzer and ammonia synthesis technologies that enable cost-effective production. Unlike conventional production methods, FuelPositive's process uses renewable energy sources such as solar and wind power that are consistent with carbon-neutral production.
In September 2023, the company announced that it had received third-party certification of its initial ammonia output. The company collected five samples of produced ammonia at random times during the evaluation period. The samples were then sent to Ortech Consulting Inc., a third-party testing laboratory in Toronto, Canada. Ortech Consulting confirmed FuelPositive’s internal mass spectrometer readings and indicated that each random sample of anhydrous ammonia was on target, consistent throughout the samples.
…Government support for sustainable solutions includes funding & incentives…
Growing recognition by governments, corporations and individuals of the need for environmental and sustainable solutions is expected to drive demand for green technologies and solutions. With governments around the world increasingly recognizing the importance of green technologies in achieving climate goals, FuelPositive believes it is well-positioned to benefit from various government incentives, grants, and subsidies aimed at promoting clean energy technologies.
For instance, on October 10, 2023, the company announced that it will receive funding of up to $1.9 million through Canada’s Research and Innovation Stream of the Agriculture Clean Technology (ACT) Program. This funding is expected to help the company continue to adapt its technology for the commercial needs of farmers and other end users and to move closer to large-scale production and commercialization.
Addressing global food security issues…
Among its many applications, ammonia is essential for global food security. Roughly 80% of traditional ammonia (which is produced under more carbon intense methods, as noted) is earmarked for use in the agriculture sector, primarily as fertilizer, although Green Ammonia can be used for a variety of applications, in addition to fertilizer. The company's initial target market will be individual farmers. Longer-term, FuelPositive expects its technology can be used for a variety of applications.
As FuelPositive prepares to commercialize Green Ammonia solutions to enable customers to produce Green Ammonia on their premises as needed, the company’s initial target market is independent farmers, as noted. Smaller farmers are likely to require solutions that are practical for them in terms of price, convenience and ease of use. It seems that many of the other companies focused on developing Green Ammonia solutions are less focused on this niche than on the expected demand from larger reseller players, according to the company.
The company launched pre-sales last year and is optimistic about the level of interest it has received. FuelPositive has indicated that at this point, the company has prequalified interest on the first 30 systems, with more than 600 systems in the pipeline. The company expects to begin shipments by the end of 2024.
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I have a stock, NAVB (Navidea Biopharmaceuticals, Inc.) that was taken off the AMEX exchange about a week ago and put on OTC PINK. Ihub's Streamer still thinks it is on AMEX so no new trading data is coming through. Thanks for any help on your part to fix this.
NEWS -- Plus Therapeutics to Present at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar
Update on the ReSPECT-GBM Trial, including Phase 2, with Rhenium-186 Obisbemeda in Recurrent Glioblastoma will be Presented at SNO Annual Meeting
AUSTIN, Texas, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that it will present four posters and one oral presentation at the Society for NeuroOncology (SNO) 28th Annual Meeting being held November 15-19, 2023 in Vancouver, Canada. In addition, the Company plans to host a virtual key opinion leader (KOL) webinar after the conference, featuring Andrew Brenner, MD, PhD (Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio), to discuss new data from the Phase 2 trial of Rhenium-186 Obisbemeda in recurrent glioblastoma (rGBM) that will be presented at SNO.
SNO 28th Annual Meeting – Vancouver Convention Centre
Oral Presentation
Title: Multi-parametric MRI and SPECT Assessment of Treatment Dose and Efficacy in Respect-GBM for recurrent glioblastoma (rGBM)
Presenter: Andrew Brenner, MD, PhD
Date/Time: Saturday, November 18, 2023 at 5:05 pm – 5:10 pm PT
Location: Room 118-120
Posters – Friday, November 17, 2023 at 7:30 pm – 9:30 pm PT in Exhibit Hall A/B
Title: Update Report of the ReSPECT-GBM Phase I/IIa Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma [rGBM] via Convection Enhanced Delivery (CED)
Presenter: Andrew Brenner, MD, PhD
Title: Rhenium-(Re-186)-obisbemeda [Re-186-nanoliposome] (186RNL) Phase 2 for recurrent glioblastoma (rGBM) via Convection Enhance Delivery [CED]
Presenter: Andrew Brenner, MD, PhD
Title: Rhenium (Re-186) obisbemeda{Re-186-Nanoliposome (186RNL)} in Leptomeningeal Metastases [LM] Phase 1/2a Dose Escalation Trial: Initial Safety and Feasibility
Presenter: Andrew Brenner, MD, PhD
Title: Efficacy among therapeutically effective absorbed dose patients in ReSPECT-GBM phase I of rhenium-186 nanoliposome (186RNL) in recurrent glioblastoma (rGBM) compared to an external control arm (ECA)
Presenter: Lisa Ensign, PhD
A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- RG6501 (OpRegen®) Phase 1/2a Results to Be Featured at Eyecelerator at 2023 American Academy of Ophthalmology (AAO) Annual Meeting
Company Also Will Present at "Mapping the Future of Geographic Atrophy" Session at Eyecelerator@AAO 2023
CARLSBAD, Calif., October 24, 2023--(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 Brian M. Culley, Lineage’s Chief Executive Officer, has been invited to present as part of the "Mapping the Future of Geographic Atrophy" session at Eyecelerator 2023, on Thursday, November 2nd, 2023, at 10am PT. The session will also feature executive presenters from Apellis Pharmaceuticals, Iveric Bio, Annexon Biosciences, Aviceda Therapeutics, and ONL Therapeutics, alongside panelists, including Wiley Chambers, M.D., Director, Division of Ophthalmology, U.S. Food and Drug Administration, David Lyons, Ph.D., CFA, Janus Henderson Investors, and Namrata Saroj, OD, Principal, All Eyes Consulting.
In addition, the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure and continued clinical benefit in subjects from a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier: NCT02286089), have been accepted for presentation at Eyecelerator 2023. The presentation, "Subretinal Delivery of OpRegen, A Suspension of Allogeneic Retinal Pigment Epithelial (RPE) Cells in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)," will be presented as part of the Presenting Company Breakout Session, between 1 – 2:45pm PDT, by Gary S. Hogge, D.V.M., M.S. Ph.D., Lineage’s Senior Vice President, Clinical and Medical Affairs. Eyecelerator will occur prior to the American Academy of Ophthalmology (AAO) 2023 Annual Meeting and will be held at the San Francisco Marriott Marquis on Thursday, November 2nd, 2023.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD). OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About Eyecelerator
Eyecelerator brings the future of ophthalmology into focus. A partnership between the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS), Eyecelerator advances eye care innovation by connecting mission-driven entrepreneurs, investors, physicians, and business leaders through next-generation business conferences. Eyecelerator 2023 will provide a day of insightful, KOL-driven programs, including the latest industry advancements, investment trends, and innovative products disrupting eye care. For more information visit https://www.eyecelerator.com/ or follow the organization on Twitter: @Eyecelerator.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology (AAO) is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the organization protects sight and empowers lives by setting the standards for ophthalmic education and advocating for our patients and the public. AAO innovates to advance the ophthalmology profession and to ensure the delivery of the highest-quality eye care. The mission of the AAO is to protect sight and empower lives by serving as an advocate for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology. For more information visit https://www.aao.org/ or follow the organization on Twitter: @AAO_ophth or @AcademyEyeSmart.
About the Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to dry-form AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives are to evaluate the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231024732155/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics to Announce Third Quarter 2023 Financial Results and Host Conference Call on October 31, 2023
AUSTIN, Texas, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report third quarter 2023 financial results on Tuesday, October 31, 2023, 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.
Conference Call & Webcast
Tuesday, October 31, 2023 @ 5:00 PM ET
Dial in #: https://register.vevent.com/register/BI484eba10ce0d4bc292c51db6fc396f0c
Webcast: https://edge.media-server.com/mmc/p/vt5rg89x
Participants may also pre-register any time before the call through the dial in # link. 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 Investors’ 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 developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Oncolytics Presents Positive Updated Pancreatic Cancer Data from GOBLET Phase 1/2 Study at ESMO
7.2 months mPFS and 10.6 months interim median OS surpass historical outcomes by = 25%
T-cell expansion data correlate with tumor response, providing important proof-of-concept
SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY),( Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of positive, updated results from the Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.
"We are very pleased to share such positive and consistent data on pelareorep from the PDAC arm of the GOBLET study, including an impressive overall response rate, 7.2 months of median progression-free survival, interim median overall survival of 10.6 months, and expansion of both pre-existing and new T-cell clones. These data build upon results from previous studies showing the clinical benefit of pelareorep combination therapy in PDAC and support the decision to move to a licensure-enabling study in pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Everything we do at Oncolytics is focused on advancing the development of our immunotherapy candidate, pelareorep, with a goal of providing improved care and longer survival for patients with pancreatic cancer and other tumor types. The data we are presenting at ESMO provide a solid foundation as we advance our pancreatic cancer program through the Precision PromiseSM Phase 3 trial in this indication."
Summary of Data and Findings from the PDAC Arm of the Phase 1/2 GOBLET Study:
Tumor Responses: Consistent with the abstract, data from the study outlined patient responses, including:
NEWS -- Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study
Results met efficacy criteria for enrollment expansion and provide support for pelareorep's mechanism of action
SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.
"The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "In a patient population that had failed multiple rounds of treatment, we continue to see pelareorep's ability to synergize with atezolizumab by generating an immune response, including the expansion of T cell clones. The translational data from this cohort are consistent with the observed clinical response, providing further support for pelareorep's mechanism of action as a potential backbone immunotherapy for patients with gastrointestinal and other forms of cancer."
"We designed the GOBLET study to evaluate pelareorep's ability to improve clinical outcomes in different gastrointestinal cancers, including at different disease stages, and to better understand pelareorep's mechanism of action by generating strong translational data. The data from this arm of the study demonstrate that pelareorep is taken up by tumor cells and stimulates T cell expansion even in heavily pre-treated colorectal cancer patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "These patients demonstrated a 40% disease control rate, a progression-free survival of 2.8 months, a median overall survival of 8.0 months, and a 12-month survival rate of 33%, exceeding historical results1-3. These findings are encouraging given that exhaustion of tumor-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab. These data also support pelareorep's immunologic mechanism of action and will inform our plans for further development."
GOBLET Study 3L Metastatic CRC Patient Overview:
Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil. The 15 evaluable patients enrolled in the first stage of the study have been evaluated based on a September 18, 2023 data cut-off date. The enrolled patient population included patients with an ECOG score of =1 and confirmed colorectal cancer, regardless of microsatellite instability status.
References
1. Mayer et al. N Engl J Med 2015; 372:1909-1919. DOI: 10.1056/NEJMoa1414325
2. Moriwaki et al. The Oncologist 2018; 23(1):7-15. DOI: 10.1634/theoncologist.2017-0275
3. Bachet et al. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698
Poster Information
Poster Title: Pelareorep + atezolizumab and chemotherapy in third-line (3L) metastatic colorectal cancer (mCRC) patients – Interim results from the GOBLET study
Final Publication Number (FPN): 619P
Poster Date: October 22, 2023
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);
2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action, and benefits of pelareorep as a cancer therapeutic; our stated goals and objectives; and our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-achieves-success-criteria-for-efficacy-in-the-third-line-colorectal-cancer-cohort-of-the-goblet-study-301964255.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Theriva™ Biologics Presents Survival Outcomes Data from Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck at ESMO Congress 2023
-Results show enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies-
-Key Opinion Leader (KOL) webinar featuring expert oncologist Ricard Mesia M.D., Ph.D., to be held today, Monday, October 23, 2023 at 8:00 a.m. ET-
ROCKVILLE, Md., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced new clinical data from the Phase 1 investigator-sponsored study with the Institut Catala d’Oncologia (ICO) evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). These data were presented at the European Society for Medical Oncology (ESMO) Congress, held both virtually and in Madrid, Spain from October 20-24, 2023.
“Results presented at ESMO further validate VCN-01’s unique mechanism of action for devastating cancers with high unmet need,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We are encouraged by the data generated to date, highlighted by the enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies. These results build on the previously reported acceptable safety profile seen with sequential dosing of VCN-01 and durvalumab. Taken together, we believe VCN-01 based combinations may address the need for improved treatments with the potential to overcome previous resistance to anti-PD-(L)1 therapies in patients with R/M HNSCC.”
The poster (#937P) titled “Survival Outcomes in Phase I Trial Combining VCN-01 and Durvalumab (MEDI4736) in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Refractory to Previous Immunotherapy Treatment,” was presented by Maria Jové (Hospitalet de Llobregat, Spain).
Presentation Highlights:
Key Takeaway: VCN-01 combined with durvalumab showed encouraging overall survival (OS) in patients who previously progressed on anti-PD(L)-1 therapy.
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Friday, November 3, 2023, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Oct. 20, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that it will host a conference call and webcast on Friday, November 3, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter of 2023.
Conference Call & Webcast
Date: Friday, November 3, 2023
Time: 8:30 a.m. ET
Dial-In – North American Toll-Free: (888) 664-6383
Dial-In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 6026-0546
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 archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 260-546#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
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
Logo: https://mma.prnewswire.com/media/1808285/4295352/Oncolytics_Biotech_Grey.jpg
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-recent-operational-highlights-301962804.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Theriva™ Biologics Announces Presentation at ESMO Congress 2023 Featuring Survival Outcomes in Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
ROCKVILLE, Md., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced a presentation of Phase 1 data from the investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). Encouraging survival was observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 in combination with durvalumab. Data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023.
“We are encouraged by the biological activity observed in R/M HNSCC patients previously treated with anti-PD(L)-1 agents, where new options are urgently needed to offer patients the best chance of long-term survival,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Results show enhanced patient survival, which correlated with VCN-01 induced upregulation of PD(L)-1 and underscores the promise of VCN-01-based combination approaches that may transform treatment for devastating cancers with high unmet needs. We look forward to leveraging our findings as we advance VCN-01 through clinical development.”
Key data and conclusions featured in the ESMO presentation include:
NEWS -- Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023
Abstracts Overview
Preliminary updated PDAC data show 6-month overall survival rate of 82%
Results from pelareorep combination in mCRC met the Stage 1 success criteria
SAN DIEGO and CALGARY, AB, Oct. 16, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain.
Abstracts Overview
Abstracts Summaries
Abstract 1623P
NEWS -- Lineage Announces Issuance of U.S. Patent Covering Proprietary Manufacturing and Differentiation Process for Retinal Pigmented Epithelial Cells
CARLSBAD, Calif., October 11, 2023--(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 the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,746,324, entitled "Large Scale Production of Retinal Pigment Epithelial Cells". The patent, which has been exclusively licensed to Lineage, has an expected expiration date of July 28, 2036. RG6501 (OpRegen®) is a suspension of human allogeneic RPE cells currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. The program is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group.
"This U.S. patent further enhances the value of our lead program, OpRegen, which is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114)," stated Brian M. Culley, CEO. "Importantly, Lineage is continuing to demonstrate its ability to benefit from decades of experience in the growth and differentiation of pluripotent cells, while simultaneously inventing and patenting new process development methods, to support long periods of exclusivity to our pipeline of cell transplant programs."
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD; and the potential value and benefits of this patent and our development capabilities, and any potential competitive advantages thereof. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that potential benefits of the Company’s intellectual property may not be realized; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231011379671/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- FuelPositive Announces $1.9-million Government of Canada Funding Commitment
WATERLOO, Ontario, Oct. 10, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) announces that it will receive a funding grant of up to $1.9 million through the Research and Innovation Stream of the Agriculture Clean Technology (ACT) Program, delivered by Agriculture and Agri-Food Canada (AAFC).
AAFC has made this significant commitment to FuelPositive’s “Green NH3 Demonstration Phase Project” in support of the commercialization of the FP300 Green Ammonia system.
The funding provided through the ACT Program will help the Company gather the information needed to continue to adapt its technology to the commercial needs of farmers. The Green Ammonia Demonstration Phase consists of building and testing three Green Ammonia demonstration systems. Each system represents an improvement to the intellectual property and technological advancement over the previous system, bringing the Company closer to achieving its efficient and sustainable, large-scale production objectives.
Ammonia is essential for global food security. Today, approximately 80% of the ammonia produced goes towards the world's fertilizer needs.1 While ammonia is vital to feeding the world’s growing population, the current ammonia industry, which primarily produces grey ammonia, is highly carbon-intensive. As the world strives to achieve global food security utilizing grey ammonia fertilizers, it simultaneously pollutes the environment needed to grow food. This dilemma, in addition to unpredictable pricing and supply uncertainty, has frustrated and confounded farmers and governments alike.
Until now, grey ammonia production was exclusively produced with fossil fuels. As a result, for every tonne of grey ammonia produced, 1.8 to 2.7 tonnes of harmful greenhouse gas (GHG) emissions are released into the atmosphere.2 Grey ammonia is then transported, often across continents, oceans, countries and cities, and finally to a distributor, before finding its way to each customer’s location. This current distribution process adds additional cost and substantial GHG emissions to an already carbon-intensive grey ammonia production process.
FuelPositive’s decentralized Green Ammonia production takes fossil fuels out of the equation. FuelPositive’s Green Ammonia system consists of a nitrogen generator to produce nitrogen from the air, an electrolyzer to produce hydrogen and oxygen from water and a patent-pending Green Ammonia synthesis converter that operates with sustainable sources of electricity, eliminating the need for fossil fuels.
Quotes:
NEWS -- Tokens.com Launches Game for Polysleep in Fortnite
TORONTO, October 10, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that provides products and services that connect brands to consumers in 3D internet environments, is pleased to announce that it has successfully launched a customized game in the widely popular Fortnite game platform for Polysleep, a leading Canadian mattress company and sleep technology pioneer.
Tokens.com subsidiaries, Metaverse Group and Hulk Labs, collaborated to build and launch a branded game for Polysleep in Fortnite called Woolen Warfare. Woolen Warfare is a Polysleep branded, competitive multiplayer king of the hill game developed by the Hulk Labs team using Fortnite Creative 2.0 in Unreal Editor For Fortnite (UEFN).
"We're not just launching another game; we're revolutionizing the way brands interact with audiences," said Andrew Kiguel, CEO of Tokens.com. " ‘Woolen Warfare' represents a new frontier for marketing, blending the thrill of competitive gaming with the essence of brand identity. We are setting a new standard for what's possible for brands in existing popular 3D games."
Hulk Labs and Metaverse Group have the ability to program on Unity and Unreal Engine to develop activations in Fortnite, Roblox, and many other online platforms. Additionally, the Company is developing expertise to launch games and apps for the new Apple Vision Pro scheduled for release in 2024.
Tokens.com works with forward-thinking brands looking to reach Gen Z, Alpha, and Millennial consumers. A report from Deloitte states, 96% of Millenials, Gen Alpha, and Gen Z located in the United States play video games regularly averaging 11-13 hours per week. Our mission is to craft distinctive branded gaming experiences within these ecosystems, by aligning with client objectives, driving distribution through influencers, streamers and paid media.
"Our objective is to seamlessly blend cutting-edge technology with the gaming experience, allowing gamers to enjoy their favorite pastime while encouraging healthy sleep habits," said Jeremiah Curvers, CEO of Polysleep.
Fortnite boasts an impressive average of 239 million monthly players, where traditional online advertising delivery channels have not yet saturated the attention of gamers in the same ways as social, display and video have. Thus by introducing engaging and innovative branded games, Tokens.com offers brands unparalleled access to a vast, untapped audience. This approach transcends the limitations of conventional marketing strategies, capturing the attention of a new generation of consumers. Tokens.com is committed to delivering a tailor-made service, ensuring that each branded experience is meticulously curated to resonate with its clients' unique vision and brand identity.
Explore Woolen Warfare by Polysleep using island code 3511-4821-9572. Players can drop in for a king of the hill gamemode where players will be able to see their standings on the leaderboard and compete for the top score. For more information on Woolen Warfare by Polysleep visit www.woolenwarfare.com.
Join members from the Tokens.com and Polysleep team on X Tuesday October, 10 at 4:30 EST to learn more. Follow the link to join X Spaces https://x.com/i/spaces/1PlJQDRABNvGE.
Brands and businesses interested in a fresh approach to accessing clients can contact us at mailto://info@metaversegroup.com and mailto://Contact@tokens.com.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centers, and 3D branded content, ii) web2 and web3 game development and game analytics, and ii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
About Polysleep
Polysleep is a pioneering sleep technology company dedicated to improving the sleep quality of individuals across the globe. With innovative products and a commitment to promoting healthy sleep habits, Polysleep continues to lead the way in sleep innovation.
For more information visit https://polysleep.com/.
Media Contact: Victoria Bakos – Polysleep
Email: mailto://victoria@polysleep.com
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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/20231010495476/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 Launches Game for Polysleep in Fortnite
TORONTO, October 10, 2023--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology company that provides products and services that connect brands to consumers in 3D internet environments, is pleased to announce that it has successfully launched a customized game in the widely popular Fortnite game platform for Polysleep, a leading Canadian mattress company and sleep technology pioneer.
Tokens.com subsidiaries, Metaverse Group and Hulk Labs, collaborated to build and launch a branded game for Polysleep in Fortnite called Woolen Warfare. Woolen Warfare is a Polysleep branded, competitive multiplayer king of the hill game developed by the Hulk Labs team using Fortnite Creative 2.0 in Unreal Editor For Fortnite (UEFN).
"We're not just launching another game; we're revolutionizing the way brands interact with audiences," said Andrew Kiguel, CEO of Tokens.com. " ‘Woolen Warfare' represents a new frontier for marketing, blending the thrill of competitive gaming with the essence of brand identity. We are setting a new standard for what's possible for brands in existing popular 3D games."
Hulk Labs and Metaverse Group have the ability to program on Unity and Unreal Engine to develop activations in Fortnite, Roblox, and many other online platforms. Additionally, the Company is developing expertise to launch games and apps for the new Apple Vision Pro scheduled for release in 2024.
Tokens.com works with forward-thinking brands looking to reach Gen Z, Alpha, and Millennial consumers. A report from Deloitte states, 96% of Millenials, Gen Alpha, and Gen Z located in the United States play video games regularly averaging 11-13 hours per week. Our mission is to craft distinctive branded gaming experiences within these ecosystems, by aligning with client objectives, driving distribution through influencers, streamers and paid media.
"Our objective is to seamlessly blend cutting-edge technology with the gaming experience, allowing gamers to enjoy their favorite pastime while encouraging healthy sleep habits," said Jeremiah Curvers, CEO of Polysleep.
Fortnite boasts an impressive average of 239 million monthly players, where traditional online advertising delivery channels have not yet saturated the attention of gamers in the same ways as social, display and video have. Thus by introducing engaging and innovative branded games, Tokens.com offers brands unparalleled access to a vast, untapped audience. This approach transcends the limitations of conventional marketing strategies, capturing the attention of a new generation of consumers. Tokens.com is committed to delivering a tailor-made service, ensuring that each branded experience is meticulously curated to resonate with its clients' unique vision and brand identity.
Explore Woolen Warfare by Polysleep using island code 3511-4821-9572. Players can drop in for a king of the hill gamemode where players will be able to see their standings on the leaderboard and compete for the top score. For more information on Woolen Warfare by Polysleep visit www.woolenwarfare.com.
Join members from the Tokens.com and Polysleep team on X Tuesday October, 10 at 4:30 EST to learn more. Follow the link to join X Spaces https://x.com/i/spaces/1PlJQDRABNvGE.
Brands and businesses interested in a fresh approach to accessing clients can contact us at mailto://info@metaversegroup.com and mailto://Contact@tokens.com.
About Tokens.com
Tokens.com is a technology company that builds products and services that connects brands to consumers in 3D internet environments, including popular gaming and metaverse platforms.
Our solutions give our clients a more engaging way to connect with their existing clients, and access to a new generation of consumers who spend time on platforms such as Roblox and Fortnite.
Our key areas of focus are: i) branded virtual stores, sales centers, and 3D branded content, ii) web2 and web3 game development and game analytics, and ii) innovative e-commerce solutions that integrate shopping into existing popular gaming platforms.
Tokens.com also manages an inventory of valuable cryptocurrency, digital real estate, and a collection of top ranked crypto related domain names.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on X, LinkedIn, and YouTube.
About Polysleep
Polysleep is a pioneering sleep technology company dedicated to improving the sleep quality of individuals across the globe. With innovative products and a commitment to promoting healthy sleep habits, Polysleep continues to lead the way in sleep innovation.
For more information visit https://polysleep.com/.
Media Contact: Victoria Bakos – Polysleep
Email: mailto://victoria@polysleep.com
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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/20231010495476/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 Completes Dosing in Cohort 4 of ReSPECT-LM Phase 1 Clinical Trial of Rhenium (¹86Re) Obisbemeda in Leptomeningeal Metastases
AUSTIN, Texas, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it has completed dosing in Cohort 4 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. In addition, the Company has completed the transfer of proprietary materials, protocols, and equipment from Biocept under the terms of the recently announced expanded agreement for CNSide, a cerebrospinal fluid (CSF)-based tumor cell capture and enumeration assay being utilized in the ReSPECT-LM clinical trial.
“The speed at which we are enrolling in the ReSPECT-LM trial reflects multiple factors, including the increasing number of patients diagnosed with LM, the lack of good therapeutic options and growing enthusiasm for the trial,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “Furthermore, significant updates on both the ReSPECT-LM and ReSPECT-GBM studies are planned for November 15-19, 2023 at the Society for Neuro-Oncology (SNO) Annual Meeting.”
Phase 1, Part A of the ReSPECT-LM trial (Cohorts 1-3) is complete and demonstrated an average 53% reduction in CNSide tumor cell counts at Day 28 post-treatment in 10 patients receiving a single administration of rhenium (186Re) obisbemeda. The FDA has approved continued dose escalation and expansion into Part B (Cohorts 4-7). Completion of dosing in Cohort 4 was the fastest enrollment of all the Cohorts to date. There have been no observed dose limiting toxicities with radiation doses of up to 44.10 millicuries. The Company plans to initiate dosing in Cohort 5 this quarter, pending Data Safety Monitoring Board (DSMB) approval. After the update at the SNO meeting in November, the Company anticipates additional data releases in 2024.
The CNSide assay has potential as: an LM diagnostic assay, a surrogate endpoint in clinical trials for CNS cancers such as LM, and as a disease monitoring biomarker assay in the management of patients undergoing radiotherapy for LM. The acquired materials and protocols from Biocept help ensure Plus’ access to the CNSide assay in the ongoing ReSPECT-LM Phase 1 clinical trial with rhenium (186Re) obisbemeda. Plus Therapeutics retains its option, solely at the Company’s discretion, to acquire an exclusive field of use license on the CNSide assay in return for a $1.0 million payment, if exercised prior to January 1, 2025.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM, and the ReSPECT-LM Phase 1 program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About CNSide
CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize, and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer which are leading causes of LM. CNSide provides a robust quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or radiologic monitoring.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
1 The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics to Participate in the Jones Trading Healthcare Summit and ThinkEquity Conference in October
AUSTIN, Texas, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that company management will attend and hold one-on-one investor meetings at the upcoming Jones Trading 2023 Healthcare Summit being held October 9-11, 2023 in Miami, FL. Marc H. Hedrick, M.D., President and Chief Executive Officer, will also present and hold one-on-one investor meetings at the upcoming ThinkEquity Conference being held on October 19, 2023 in New York, NY.
Jones Trading 2023 Healthcare Summit – October 9-11, 2023
Format: One-on-one investor meetings
Location: Eden Roc Miami Beach, Miami Beach, FL
Link: Register here
ThinkEquity Conference – October 19, 2023
Format: Corporate Presentation
Date/Time: Thursday, October 19, 2023 at 12:30-1:00pm ET
Participant: Marc H. Hedrick, M.D., President & CEO, Plus Therapeutics
Location: Mandarin Oriental, New York
Webcast: Register here
Please contact your Jones or ThinkEquity representative to schedule one-on-one meetings with the management team during the conferences.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Navidea Biopharmaceuticals, Inc. Announces NYSE American’s Decision to Suspend Trading In Its Common Stock
The Company announced today that the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the NYSE American LLC upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. The company maintains strategic focus on its Fix, Fund, Propel approach.
DUBLIN, Ohio, October 06, 2023--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the Listings Qualifications Panel (the "Panel") of the Committee for Review of the Board of Directors of the NYSE American LLC (the "Committee") upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. Accordingly, the staff of NYSE Regulation has suspended trading in the common stock of Navidea from the NYSE American. The Company anticipates that its common stock will begin trading on the over-the-counter (OTC) markets.
The Company has a right to request a review of the Panel’s decision to delist the common stock by the Committee by making a written request within 15 calendar days of the date of the Panel’s decision. The filing of an application with the Securities and Exchange Commission to delist the common stock is pending completion of all applicable procedures, including any appeal by the Company of the Panel’s decision. The Company is in the process of determining whether to request a review of the Panel’s decision.
In the event the Company’s common stock is delisted, the Company will continue to be a Securities and Exchange Commission ("SEC") reporting company. The Company may then also consider relisting its common stock on a national securities exchange in the future if the Company determines that doing so is in the best interest of the Company and its stockholders. The Panel’s decision does not affect Navidea’s business operations.
"We are respectful of the process and the perspective of the Exchange’s staff and Listings Qualifications Panel," said Craig A. Dais, Navidea’s Chief Financial Officer. "We also believe in the progress the Company continues to make, and the impact of the changes being made to move the Company forward. We will maintain our focus on exploring all strategic options which advance us toward the Company’s objectives, including continuing active discussions focused on licensing partnerships and other non-dilutive capital raise options, in order to meet the Company’s business goals and deliver value to our stockholders."
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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 the Company’s progress, strategic options, business goals, 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 common stock is subject to delisting from the NYSE American under a currently pending delisting proceeding; 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/20231005935545/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures