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NEWS -- Tokens.com Announces Commencement of Trading on TSX Venture Exchange
TORONTO, March 28, 2024--(BUSINESS WIRE)--Tokens.com Corp. ("Tokens.com" or the "Company") (TSX-V: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF), a technology investment company, is pleased to announce that its common shares (the "Common Shares") and warrants (the "Warrants") will commence trading at the opening of markets today on the TSX Venture Exchange (the "TSXV").
Shareholders are not required to exchange their securities certificates or to take any other action in connection with such listing, as there will be no change to the trading symbol or CUSIP for the Common Shares and the Warrants. The Common Shares will continue to trade under the symbol "COIN" and the Warrants will continue to trade under the symbol "COIN.WT". The Common Shares will also continue to trade under the symbol "SMURF" on the OTCQB Markets in the United States and under the symbol "76M" on the Frankfurt Exchange.
About Tokens.com
Tokens.com is a technology investment company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240328975403/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
NEWS -- Tokens.com Announces Commencement of Trading on TSX Venture Exchange
TORONTO, March 28, 2024--(BUSINESS WIRE)--Tokens.com Corp. ("Tokens.com" or the "Company") (TSX-V: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF), a technology investment company, is pleased to announce that its common shares (the "Common Shares") and warrants (the "Warrants") will commence trading at the opening of markets today on the TSX Venture Exchange (the "TSXV").
Shareholders are not required to exchange their securities certificates or to take any other action in connection with such listing, as there will be no change to the trading symbol or CUSIP for the Common Shares and the Warrants. The Common Shares will continue to trade under the symbol "COIN" and the Warrants will continue to trade under the symbol "COIN.WT". The Common Shares will also continue to trade under the symbol "SMURF" on the OTCQB Markets in the United States and under the symbol "76M" on the Frankfurt Exchange.
About Tokens.com
Tokens.com is a technology investment company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240328975403/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
NEWS -- Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual Conference
AUSTIN, Texas, March 27, 2024 (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 (CNS) cancers, today announced that it will present a poster at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference, which will be held April 5-7, 2024, in Orlando, Florida.
NCCN 2024 Annual Conference – Orlando World Center Marriott
Poster: Friday, April 5, 2024 at 7:30am-8:30 am and 11:55am – 1:10 pm ET in the Exhibition Hall
Title: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases Phase 1 Dose Escalation Trial: Update of Initial Safety and Feasibility
Presenter: Norman LaFrance, MD, ME, FACP, FACNP, FACNM (Chief Medical Officer of Plus Therapeutics)
A copy of the poster presentation 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 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, including statements regarding clinical trials, expected operations and upcoming developments. 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 “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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 -- Provectus Biopharmaceuticals Announces Exclusive Worldwide License Agreement with University of Miami for Photodynamic Antimicrobial Treatment of Different Eye Infections with Rose Bengal Sodium
NEWS -- Q4 2023 Theriva Biologics Inc Earnings Call
Participants
Steven A. Shallcross; CEO, CFO, Treasurer, Corporate Secretary & Director; Theriva Biologics, Inc.
Presentation
Operator
And greetings, and welcome to the Theriva Biologics full year 2023 investor conference call.
At this time, all participants are in a listen only mode. As a reminder, this conference is being recorded. I would now like to turn the call over to your host Chris Calabrese with LifeSci Advisors. Thank you. You may begin.
Thank you, operator, and good morning, everyone. Welcome to the Theriva Biologics full year 2023 investor conference call. Leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of Theriva Biologics; Dr. Medel, Qwest guy of General Director of the RevA biologics, European subsidiary, and Dr. Vince wager, Head of Corporate and Product Development of Spiriva biologics are also on the call and will be available to answer questions during the Q&A session.
The review Biologics issued a press release this morning, which provided operational highlights and included the financial results for the full year ending December 31, 2023. The press release can be found in the Investors section of the Company's website at w. w. w. dot Areva bio.com, together with the annual report on Form 10-K for full year ended December 31, 2023, which we plan to file today with the Securities and Exchange Commission. In addition to the phone line, this call is being streamed live via webcast, which will be archived on the Company website, w. w. w. dot Areva bio.com for 90 days.
During this call, certain forward-looking statements regarding Theriva Biologics and DCM 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 three-V 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 to review. 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 turn the call over to Steve.
Steven A. Shallcross
Thank you, Chris, and good morning. I appreciate everyone for taking the time to join us today. In 2023, we continued to make steady progress to drive forward our oncology forward focused portfolio designed to address unmet needs for difficult to treat cancers. 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 adeno virus designed to selectively replicate within the tumor, the grade the tumor matrix increase tumor immunogenicity. We believe these multiple modes of action position, VCN-01 for optimized tumor killing in combination with chemotherapy and immuno-oncology products and otherwise refractory solid tumors.
We have shown that repeated systemic dosing of VCN-01 is feasible from a safety perspective, and we can now focus on whether the repeated dose VCN, Reg VCN-01 regimen may lead to improved clinical outcomes for patients beyond VCN-01, we are pursuing new oncolytic virus candidates to leverage our novel human shield technology, which is designed to protect systemically administered oncolytic viruses from the host immune system and may facilitate more frequent repeated administration of oncolytic virus therapies. This movement may enable our pipeline of products to be used in standardized treatment cycles that are well established in cancer, chemotherapy and immunotherapy.
Additionally, as part of our oncology focus portfolio. We continue to screen and enroll patients in the second cohort of the Phase Ib IIa clinical trial of sin for design to prevent potentially fatal adverse outcomes in patients who undergo alginate committed periodic cell transplant ACT. to treat hematologic cancers. With our 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.
With this brief introduction, I'd like to expand on key pipeline updates. Starting with our lead program. VCN-01 BCL. one has been administered to more than 100 patients across diverse indications, which speaks to the broad therapeutic potential, including pancreatic ductal adenocarcinoma or PDX retinol BLISS, stoma, head and neck squamous cell carcinoma, colorectal cancer and ovarian cancer.
VCN-01 has been granted orphan drug designation in the US and Europe for the treatment of pancreatic cancer and in the US for retinol, but Soma, providing additional opportunities for regulatory engagement and if approved market exclusivity, our most advanced program for VCN-01 is in PDX for which incidence continues to rise in an indication that has one of the lowest survival rates among all cancers.
It is well established that the pediatric tumor matrix is one of the key reasons for the overall poor therapeutic outcomes for these patients. We believe the CNO one's differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PTAC. by degrading the twofer matrix and increasing tumor access by co administering cancer therapies. We are pleased to report that dosing is well underway for Viraj, our Phase 2b trial of VCN-01 in combination with standard of care chemotherapy, gemcitabine and nab-paclitaxel, which is being evaluated as a first-line therapy for patients with PDX with six sites open in the US and nine sites opened in Spain. Faraj remains on track to complete enrollment in the first half of 2024.
In the first quarter of 2024, we completed the first safety review with the Independent Data Monitoring Committee or IDMC with a positive recommendation from the IDMC. Faraj will continue to enroll patients without any changes to the protocol. Notably, intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials.
Importantly, no additional toxicities were observed in patients receiving a second dose of VCN-01, providing the first clinical evidence of the feasibility of repeated systemic dosing. As a reminder, primary endpoints for the Virage trial include overall survival and BCNO. one safety and tolerability. Additional endpoints include progression-free survival objective response rate measures of VCN-01 biodistribution replication, immune response and measures of the quality of life of treated patients. Since this is an open-label trial, progress will be monitored very closely in steps to accelerate the clinical program may be implemented if supported by emerging data.
More broadly, the Virage trial will enable us to determine the feasibility of repeated dosing of VCN-01 This could shift the approach to standardize treatment cycles that are well established in cancer chemotherapy and immunotherapy and may lead to improved clinical outcomes for patients with PDX and other difficult to treat solid tumors.
In addition to advancing the Virage PDN trial, we continue to work closely with key opinion leaders in the US, Europe and Central and South America, as well as with regulatory agencies to refine our clinical strategy in Renovo stoma. We believe intravitreal VCN-01 has the potential to treat vitreous seeds in children with retinol Bluestone.
Since current clinical practice varies in, there's no regulatory guidance specific to retinol plus stoma drug development. We held a pre IND meeting with the FDA in the fourth quarter of 2023 to discuss the development pathway for VCN-01 is an adjunct to chemotherapy in pediatric patients with advanced renal milestones. During our meeting with the FDA, we were provided some guidance on the potential endpoints in patient population for an advanced clinical trial and encouraged to submit a formal protocol under a US IND.
In order to provide a more detailed commentary for this program, we are encouraged by interactions with the FDA and look forward to driving this program forward.
In parallel with company-sponsored studies, the potential utility of VCN-01 is being explored and a number of investigator-sponsored studies that are underway at leading oncology research institutions around the world, notably collaborators at St. Johns and Dale have completed patient treatment in the Phase one investigator sponsored trial evaluating the safety and activity of intravitreal BC and one in pediatric patients with refractory retinol Bluestone.
The trial evaluated escalating doses of VCN-01 administered by two intravitreal injections separated by 14 days and remains on track to complete patient follow-up in the first half of 2024, which will help to inform the planned Phase 2 trial and design and the protocol. As a reminder, preclinical data has shown that topotecan treatment enhanced BCNO. one oncolytic activity against rentable stoma and more broadly reinforced VCN-01 possibility as an adjunct to intravitreal chemotherapy in patients who fail currently available treatments. We remain encouraged by the potential of this novel combination approach to provide superior clinical benefits for children with this devastating cancer.
Additionally, the University of Pennsylvania continues to enroll and treat patients in their Phase one investigator sponsored trial, administering VCN-01 with your CAR T muscle cells to patients with ovarian or pancreatic cancers. VCN-01 designed to increase tumor immunogenicity and improve access by additional therapies such as UCargo muscle cells while cell-based immunotherapies have had limited efficacy against solid tumors to date, we are encouraged by initial results highlighting the feasibility of administering VCN-01 with this type of CAR T therapy. These preliminary results were presented last year at the Society for Immunotherapy of Cancer Annual Meeting or cities. European investigators are continuing to explore the optimal dosing regimen for VCN-01 co-administered with your card muscle cells, and we look forward to further data from the study in 2024.
Turning to our ongoing Phase 2b 2a clinical trial of Washington University evaluating same for or write-backs. The trials designed to evaluate the therapeutic potential of sin for two fatal to reduce fatal adverse events related to IV beta-lactam antibiotic use and allogeneic HCT recipients, including acute graft versus host disease or AGVHD. in overgrowth and infection by pathological organisms such as C. difficile and Vanco myosin resistant and tear Koksay. The Phase 1b 2a study is designed to assess the feasibility of using sense for and consist of three sequential cohorts comparing different IV beta-lactam antibiotics following conditioning therapy in each cohort eight patients will receive and four and four receive placebo. While the data remain blinded, interim analysis suggests it's in four is well tolerated and was not observed in the blood samples of a majority of development patients.
Our second cohort is underway and is designed to evaluate SIN for combination with piperacillin tazobactam. The trial is on track to complete enrollment in the second cohort in the second quarter of 2024. This cohort will provide important additional safety information. In particular, whether oral sema four has the potential to alter IV antibiotic levels in this patient population. We look forward to sharing this data in the second half of 2024.
Overall, we are encouraged by the progress across our pipeline in the growing clinical data that underscore the promise of our systemically administered oncolytic virus in key indications and combinations. We remain focused on driving our clinical programs forward in exploring opportunities to leverage our novel albumin shield technology and exciting additional technologies from Rovi discovery platform. I'm confident that the Company's upcoming catalysts will provide a solid foundation for execution and value creation.
Specifically we remain on track to complete enrollment for the Virage study in the first half of 2024, complete follow-up in the Phase 1 investigator sponsored trial evaluating the safety and activity of intravitreal, the VCN-01 in pediatric patients with refractory reasonable stoma and the first half of 2024 and complete enrollment in the second cohort of our Phase 1b 2a clinical study of seven four for the prevention of AGVHD. in bone marrow transplant patients in the second quarter of 2024.
Now I briefly turn to our financial results for the first full year ended at December 31, 2023, general and administrative expenses decreased to $7.1 million for the year ended December 31, 2023 from $9.9 million for the year ended December 31, 2022. This decrease of 28% is primarily comprised of the decrease in the fair value of the contingent consideration of $2.8 million, along with lower salary, investor relations, legal costs, consulting fees related to the VCN. acquisition and director and officer insurance, offset by higher audit fees and other consulting fees.
The charge related to stock-based compensation expense was $0.4 million for the year ended December 31, 2023 compared to $0.4 million for the year ended December 31, 2022. Research and development expenses increased to $14.3 million for the year ended December 31, 2023 from $11.7 million for the year ended December 31, 2022.
This increase of 22% is primarily the result of higher clinical trial expenses related to our Virage Phase 2 clinical trial of VCN-01 and PDx offset by lower expenses related to our Phase 1b 2a clinical trial of sin for an allogeneic HCT recipients. The completed phase one, a clinical trial have seen 20 decreased manufacturing expenses related to our Phase 1a clinical trials in 20 and lower other indirect costs.
We anticipate research and development expense to increase as we continue enrollment in our Virage Phase two clinical trial of VCN-01 and P. deck in our ongoing Phase 1 clinical trial and renewable stoma, expand GMP manufacturing activities for VCN-01 and continue supporting RBC and 11 on other preclinical and discovery initiatives.
Research and development expense also includes a charge related to noncash stock-based compensation expense of $165,000 for the year ended December 31, 2023, compared to $112,000 for the year ended December 31, 2022. Other income was $1,442,000 for the year ended December 31st, 2023, compared to other income of $471,000 for the year ended December 31, 2022. Other income for the year ended December 31, 2024, was primarily comprised of interest income of $1,439,000 and an exchange gain of $3,000. Other income for the year ended December 31, 2022 is primarily comprised of interest income of $512,000, offset by an exchange loss of $41,000.
Cash and cash equivalents totaled $23.2 million as of December 31, 2023, compared to $41.8 million as of December 31, 2022. We remain deeply committed to improving patient outcomes for 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 delivering on our mission.
I'd like to thank the entire Theriva team, our investors and the many people who have been supportive along the way, including our patients and their families.
With that, we're happy to take questions.
Question and Answer Session
Operator
Thank you. And at this time, we'll be conducting a question and answer session. (Operator Instructions)
James Molloy, Alliance Global Partners.
Yes, good morning. Thank you very much for taking my questions. Pillow had a question looking below Stephen, Alex, Christopher, just even your mental on looking across the multiple IST.s, which are very cost efficient way of getting trials done excellent. Excellent use of capital, which you guys see as sort of most promising of like all the volatile and of course, of which seems like it might be maybe growing the task. We look across the thrust of the plethora of IST as you guys have got underway.
Steven A. Shallcross
So let me let me just highlight where what we've got going on once again. And then Manav, you could talk specifically about some of the exciting findings that we found of had disclosed at various scientific conferences. So as you're aware, we put out some incredible head and neck cancer data at asthma last October. This is using BC and one in combination with checkpoint inhibitors in patients that were refractory to previous rounds of checkpoint inhibitor therapy on someone else could talk a little bit about that.
We've got the retinol Bluestone, the program on which we've just concluded, and now we're in the middle of follow-up. And then we've got the ongoing New Penn study, which is down to of their organization, trying to isolate the right dose take forward. So we would expect to see some more of data sometime this year related to the work they're doing there.
So now maybe you could just highlight the important findings on those three studies that are that are ongoing or recently completed?
Yes, sure, sure. So obviously, the muscle complete data, let's say, from the trial in head and neck had a good percentage of asthma in October as you know, this was a trial combining VISION one with the development and efficient refractory to the action of immune checkpoint inhibitors in head and neck carcinoma.
Okay. And we have previously presented safety data that demonstrated that additional one has an acceptable safety profile when administered prior to durvalumab. And in this new presentation that we conducted in October, we presented data on efficacy.
And we have seen that the patients treated with Vision Show with an increase of restaurants, two, a subset of chemotherapy treatments after progressions and style. But specifically, we have also seen that the survival of patients has been large for a number of patients. And in fact, some patients are still alive more than four years after we didn't participate in the trial, which in my view, it's quite remarkable because those patients were entering the trial had some effect on shelf life of between three or four months. And what we are seeing obviously, it's really interesting.
And moreover, it's not just a question of efficacy that does a very good correlation between the restaurants and the biological data we are getting from the tumor biopsies of these patients. And in fact, we have seen down-regulation of the more massive genes. We have been observing increasing levels of immune markers in the tumor biopsies. And interestingly, there was a correlation between the survival and with the CPS score and a day after vision one for investigator scoring, it's a kind of marker about immunological status and what looks in our biological, the that you said that vision one treatment change in this environment and definite correlation between the magnitude of the change that we use and the survival of patients, which is I think exciting.
Obviously, it's use a proportion, but it's exciting in regional customer. We have been treating more patients. We have seen some patients with reductions that we do see it. But specifically, we have been also collecting data of combination with the chemotherapy, the chemotherapy that is using rational estimate, it's topotecan. And in this trial, we have seen not derailing the clinical patients. But in preclinical work that we have done with biopsies and from a human cells, we have been observing that there is synergy between the action of this in one and a couple of Beacon, which is very encouraging and opens the door for a combination approach in our Phase two program that is massively with cash and with FDA in our meeting.
Okay.
So basically, the data we are collecting, it's very exciting. And in my view, it's very exciting to see that in different indications, we can confirm the mechanism of action. And we can see initial evidence of activity in happening in RightNow customer, which is also the same thing that we have observed in our Phase one program in pancreatic cancer so that the data is quite consistently that way.
Thank you very much. Taking my quick follow-up on the on the retina. Last on the ISTI. when you anticipate potentially filing an IND and starting the Phase two three again, presuming the Phase one wraps up as you hope.
And then a follow-up to the Phase IIb Virage, I know the enrollment completed in first half 2024, which we just data final data top line data for us.
So Manoj, why don't you take the first one and then Vince, you could take the second guess our four original restaurant model right now we are just following the a lot of patients.
Okay. As you know, our clinical trial to treat the patient that part, it's already finished that we need to follow the patients for six months after the last dosing. So we are expecting to finish our database with data of the trial in mid-2024, probably. And after that, we need to rise to interest a rep or and start that discussion with FDA. The final design of the and the so I don't expect to go for an IND until 2024, 2025, sorry by shore because obviously we need to finish some activities. We got before submitting any AMD for RightNow customer base. We want to give some color on the pancreatic program.
Thanks, Menno. So I'll as Steve indicated, a Virage study is enrolling and we anticipate completing enrollment in the first half of this year with the with the patients only. And then we will be very closely monitoring the emergence of our data. And this there's two key outcomes one. Obviously, our primary endpoint of survival will be following those patients and the longer the better from our perspective because we want to have a good effect.
So the primary endpoint data. The survival won't read out until next year as I kind of peak when we would like to say that to be potentially in the second half, the longer as long as these patients keep going. We want patients on our drug to do well.
In the interim, we will be looking at our data to see if there's something that we can around which we can build a formal interim analysis to review with the FDA and discuss next steps how we can potentially advance our program quickly into a pivotal trial. And as we know, as you know, we've got the orphan drug designation, so we'll leverage that strategy. But again, we can't necessarily predict the timing other than later in the year for a potential interim analysis if we choose to do one. But the overall endpoints for the primary endpoint of survival will be next year
Thank you very much. And maybe a follow-up questions from me on Cyno forking giving you actually sort of the endgame for CNO for where a so what though which we anticipate sort of coming to a conclusion on that on the data, what sort of timing on that? And then can you talk a little bit about how the partnership and characterize the partnership environment currently for Finjan licensing OTOR. for linear compounds?
Steven A. Shallcross
Sure. So on, as you know, the same for trials, a single single-site study at Wash U and those partners have been outstanding on fortunately or unfortunately, on the time it takes to enroll a trial like that is subject to the number of patients that actually meet the screening criteria so they can be brought into the trial and we're going to complete that trial, as I stated earlier on in relative short order.
And then we'll obviously have some disclosure around that. This cohort is pretty important because a sin for does degrade the combination of pepper so on and take it back to him. And obviously, we're monitoring the data in this trial and we want to make sure that the antibiotic is not and interfered with in this more fragile patient population.
So once we have that data in hand, we'll make a decision about whether or not we advance into the third cohort or whether or not we have enough and to answer our questions that were brought to us by the FDA on then this asset ties in more broadly to the initiatives we have underway to identify potential partners across our entire pipeline. So we've hired some outside advisors on one group specific to help us finding a home for person for and we've had engagement.
And again, a lot of this has to do about when we have the data on. We've also have a group we're working with and outreach to potential partners for the VCNO. one platform. And once again, we've had multiple engagements and interest and we will continue those discussions. And once again, data is key and we've also have some folks that we're working with trying to find a home for the Cine 20 program.
And again, those discussions are ongoing. I think the environment has gotten a bit better recently on, I think over the last couple of years, given sort of the bear market that biotech and small and micro-cap biotech has been and has hindered a lot of discussion on, but I am more and more optimistic things seem to be picking up a little bit. And in keeping with our strategy and how we view these ongoing discussions we're not going to talk about specific interactions and when we have something, obviously we'll make a disclosure about that, of course.
Thank you very much taking questions.
Operator
Thank you. And as a reminder, if you'd like to ask a question, please press star one on your telephone keypad or pause a moment to allow for any other question. Mr. Shah cross.
I'm not showing any other questions at this time. I'll turn the floor back to you for any final.
Steven A. Shallcross
Okay. Thanks, Melissa. Well, thanks again, everyone, for taking the time to join us today. I hope you sense that we're incredibly focused on driving all of our programs forward.
We're doing this in a way which I think we're very good stewards with our cash and making and stretching that dollar the best we can to get as much data and as many clinical outcomes and results as possible.
Will continue is we just ended with Jim here to evaluate our strategic options, and we'll continue to look for ways to drive additional value for our shareholders and for the long-term success of what we're trying to do namely delivering, you know, promising treatments for very, very difficult-to-treat cancers.
Thanks again for joining us, and we look forward to keeping you updated on our progress.
Operator
Thank you. This concludes today's conference. You may disconnect your lines at this. Thank you for your participation.
NEWS -- Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic
Plus’ CSF-01 cancer cell enumeration test is a sensitive and specific diagnostic test for the presence of adenocarcinoma and melanoma cancer cells in the leptomeninges
CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials
Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024
AUSTIN, Texas, March 25, 2024 (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 (CNS) cancers, today announced it has successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials.
“Plus’ CSF-01 tumor cell enumeration assay is a highly specific and sensitive diagnostic test that is promising for both establishing the diagnosis of leptomeningeal metastases (LM) and following the disease course over time,” said Dr. Priya Kumthekar, Associate Professor, Feinberg School of Medicine, Northwestern University. “Current diagnostic methods lack the sensitivity and specificity to reliably inform clinical decision making, and the field is excited about the use of CSF-01 in the ReSPECT-LM trials as an exploratory endpoint and hopefully soon, for use in all patients in which LM is in the differential diagnosis.”
Plus’ CSF-01 cancer cell enumeration test is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in the trial’s early cohorts. In Phase 1/Part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM.
“In mid-2023, the Company licensed CSF-01, as well as a broader CSF diagnostic testing portfolio due to high conviction that routine implementation will substantially improve diagnosis and clinical management of LM,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “Our initial objective was to make the test available for our ReSPECT-LM trial patients, which is now complete. Now, we are evaluating the FORSEE clinical trial data, which we anticipate reporting in the second or third quarter of 2024.”
On December 12, 2023, Plus announced its partnership with K2bio (Houston, Texas) to implement Plus’ CSF-01 diagnostic for LM cancers in the ReSPECT-LM trials. While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025. The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT).
The FORSEE trial was performed by the original developer and licensor of CSF-01 and is a multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed LM. If the FORSEE data is positive, we intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space.
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 a 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 directly 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 off-target 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 real-time 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 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, including statements regarding clinical trials, expected operations and upcoming developments. 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 “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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 -- Tokens.com Announces Conditional Approval to List on the TSX Venture Exchange
TORONTO, March 25, 2024--(BUSINESS WIRE)--Tokens.com Corp. ("Tokens.com" or the "Company") (Cboe Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF), a technology investment company, is pleased to announce that it has received conditional approval to list (the "Listing") its common shares (the "Common Shares") and warrants (the "Warrants") on the TSX Venture Exchange (the "TSXV"), subject to the satisfaction of certain customary listing requirements.
The Company intends to delist its Common Shares and Warrants from trading on Cboe Canada effective as of the close of trading on March 27, 2024. Subject to such delisting, the Common Shares and Warrants will commence trading on the TSXV as of the open of trading on March 28, 2024.
Shareholders are not required to exchange their securities certificates or to take any other action in connection with the Listing, as there will be no change to the trading symbol or CUSIP for the Common Shares and the Warrants. The Common Shares will continue to trade under the symbol "COIN" and the Warrants will continue to trade under the symbol "COIN.WT" upon the completion of the Listing on the TSXV. The Common Shares will also continue to trade under the symbol "SMURF" on the OTCQB Markets in the United States and under the symbol "76M" on the Frankfurt Exchange.
About Tokens.com
Tokens.com is a technology investment company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240325499294/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Tokens.com Announces Conditional Approval to List on the TSX Venture Exchange
TORONTO, March 25, 2024--(BUSINESS WIRE)--Tokens.com Corp. ("Tokens.com" or the "Company") (Cboe Canada: COIN)(Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF), a technology investment company, is pleased to announce that it has received conditional approval to list (the "Listing") its common shares (the "Common Shares") and warrants (the "Warrants") on the TSX Venture Exchange (the "TSXV"), subject to the satisfaction of certain customary listing requirements.
The Company intends to delist its Common Shares and Warrants from trading on Cboe Canada effective as of the close of trading on March 27, 2024. Subject to such delisting, the Common Shares and Warrants will commence trading on the TSXV as of the open of trading on March 28, 2024.
Shareholders are not required to exchange their securities certificates or to take any other action in connection with the Listing, as there will be no change to the trading symbol or CUSIP for the Common Shares and the Warrants. The Common Shares will continue to trade under the symbol "COIN" and the Warrants will continue to trade under the symbol "COIN.WT" upon the completion of the Listing on the TSXV. The Common Shares will also continue to trade under the symbol "SMURF" on the OTCQB Markets in the United States and under the symbol "76M" on the Frankfurt Exchange.
About Tokens.com
Tokens.com is a technology investment company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240325499294/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- FuelPositive Files Patent for Green Aqueous Ammonia Production Module and Provides Update on First Farm-Ready System
Highlights:
NEWS -- FuelPositive names Counsel Public Affairs as Communications and Marketing Agency of Record
WINNIPEG, Manitoba and WATERLOO, Ontario, March 20, 2024 (GLOBE NEWSWIRE) -- FuelPositive Corporation, a leading Green Ammonia Company (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company” or “FuelPositive”) is pleased to announce Counsel Public Affairs (Counsel) as its communications and marketing Agency of Record, following a thorough search announced in a news release dated February 6, 2024.
Luna Clifford, Chief Impact Officer at FuelPositive, commented on this new partnership: "We are thrilled to welcome Counsel Public Affairs as our newly appointed agency of record. Under the dynamic leadership of Logan Ross, Senior Vice President of Communications and Campaigns, Counsel’s team possesses a targeted understanding of our technology and audiences. After an extensive search, we firmly believe Counsel is the ideal strategic choice to meet FuelPositive's expanding communications and marketing needs.”
Clifford continued: "With FuelPositive's strategic focus on sales and manufacturing in Canada and Manitoba; we actively pursued an agency equipped with comprehensive knowledge of these markets and having a long track record of supporting clients in the green energy and the AgTech sector. Counsel is strategically positioned to capitalize on increasing government support and awareness at provincial, federal, and global levels. Their deep understanding of government policies and programs will help us effectively leverage strategic opportunities.”
Logan Ross, Senior Vice President of Communications and Campaigns at Counsel Public Affairs shared her enthusiasm for the partnership, “We are thrilled to be named FuelPositive’s Agency of Record for communications and marketing services. We have a long history of helping clients to succeed in the green energy and agriculture sectors. FuelPositive’s technology has the potential to transform the green economy in this country; we can’t wait to help them tell their story in Manitoba and beyond.”
Ian Clifford, FuelPositive CEO and Board Chair, highlighted the significance of the partnership: "Choosing our strategic communications and marketing agency marks a pivotal moment as we gear up for the imminent on-farm launch of our inaugural system in Manitoba with a worldwide audience eagerly awaiting this milestone for the Company, we set our sights on nothing short of excellence in agency selection to help steer FuelPositive through this transformative phase. We foresee a successful collaboration with Counsel, echoing their excitement for the journey ahead."
Counsel will also provide FuelPositive with investor relations communications support. The engagement will be for an initial twelve-month term ending on March 14, 2025, during which time Counsel will receive a monthly retainer*. In addition, Counsel will also be entitled to receive a one-time grant of 1,200,000 incentive stock options (the “Options”) exercisable at a price of $0.05 for a period of sixty months. The Options will vest in four equal parts over twelve months with the first part vesting after three months.
About Counsel Public Affairs
Counsel is Canada’s most effective public affairs firm, specializing in government relations, strategic communications, and integrated campaigns.
Established in 2004, Counsel is a national firm with over 40 consultants in Victoria, Vancouver, Calgary, Edmonton, Regina, Winnipeg, Toronto, and Ottawa.
Counsel’s team has decades of experience and includes senior individuals who have quarterbacked national political campaigns, run provincial war rooms, written winning platforms, served as Cabinet Ministers, led First Nations, held executive roles in major corporations, and most importantly, helped hundreds of clients succeed.
About FuelPositive Corporation
FuelPositive Corporation is at the forefront of Canadian technology and is committed to delivering sustainable, environmentally responsible Green Ammonia solutions. Our innovative approach includes on-farm/on-site, containerized Green Ammonia production systems, effectively eliminating carbon emissions.
Our commercial Green Ammonia systems are versatile and serve multiple applications, including fertilizer for farming, fuel for grain drying, internal combustion engines, and hydrogen storage for fuel cells and other sectors.
Our main customer base consists of farmers, who currently utilize 80% of the global ammonia production. We address their nitrogen fertilizer needs while advocating for environmental change.
Our Canadian company leverages Canada’s expertise in technology and environmental stewardship to empower communities worldwide against food insecurity. We’re shaping a more resilient future for generations through collaboration and innovation.
FuelPositive: Fuel for a Mindful World.
See Sales details here: https://fuelpositive.com/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.
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
Logan Ross
Senior Vice President, Communications & Campaigns
Counsel Public Affairs, Inc.
mailto://lross@counselpa.com
Tel: 204.720.3662
https://www.counselpa.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.
*Counsel Public Affairs will be compensated a professional fee of $60,000.00 plus applicable taxes and disbursements for the 12-month term, which is payable monthly.
NEWS -- Scorpius Holdings Awarded Contract in Excess of $1 Million with NIH-Funded Researcher at a Major University
DURHAM, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been awarded a contract in excess of $1 million with an NIH-funded researcher at a major university.
The program involves process optimization and development of a therapeutic antibody, which Scorpius will manufacture for preclinical studies. The work will be conducted in the Company’s state-of-the-art process development lab and cGMP cleanrooms in its Mammalian Building, which is ideally suited for early-stage programs using CHO cell lines. Following process optimization and development, the Company expects to expand the scope of the agreement to include Phase 1 clinical manufacturing.
Jeff Wolf, CEO of Scorpius, stated, "Scorpius is excited to begin work with another nationally renowned university. Our selection by this leading researcher highlights our unique process development, bioanalysis, and manufacturing capabilities, which we have the ability to leverage into much larger projects as the programs progress through clinical stages and eventually into commercialization. There is a tremendous amount of innovative research being conducted at academic institutions, and Scorpius is well-suited to provide these clients with the attention and responsiveness they otherwise would not receive from a CDMO. Overall, we could not be more excited about the outlook for the business and the traction we are gaining.”
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as the Company’s expectation to expand the scope of the agreement to include Phase 1 clinical manufacturing, the Company’s ability to leverage its process development, bioanalysis, and manufacturing capabilities into larger projects as the programs progress through clinical stages and into commercialization and future traction that the Company is gaining. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
Theriva™ Biologics to Host Conference Call and Webcast to Discuss Full Year 2023 Operational Highlights and Financial Results
ROCKVILLE, Md., March 19, 2024 (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, March 25, 2024, at 8:30 a.m. ET to discuss its financial results for the full year ended December 31, 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: 13744453. 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’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.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
Source: Theriva Biologics, Inc.
NEWS -- Lineage Cell Therapeutics and the Christopher & Dana Reeve Foundation Proudly Announce the 2nd Annual Spinal Cord Injury Investor Symposium
Event Scheduled for June 26 and 27, 2024
CARLSBAD, Calif., March 18, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, and the Christopher & Dana Reeve Foundation, a non-profit organization dedicated to advancing innovative research and improving quality of life for individuals impacted by paralysis, are proud to again collaborate to present the 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS builds upon a successful inaugural event held on June 29, 2023, and will connect a diverse set of stakeholders in the field of spinal cord injury (SCI). This year’s event aims to accelerate development in SCI research and treatments by bringing together companies working in the development of treatments for SCI, with regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations and the investment community, in order to discuss perspectives on current and future treatment alternatives, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and importantly, broaden awareness of and investment capital into SCI. The 2nd SCIIS will be held on June 26 and 27, 2024 at the Sanford Consortium for Regenerative Medicine in La Jolla, CA.
"We are excited to continue our collaboration with the Reeve Foundation on this event, which provides an excellent opportunity to highlight the important work being done by for-profit and non-profit organizations alike and to broaden awareness and impact for those affected by this debilitating condition," stated Brian M. Culley, Lineage CEO. "Our aim at Lineage is to improve recovery and mobility by replacing the cells which are destroyed following a spinal cord injury. We are encouraged by the initial clinical testing which has been performed with our approach and look forward to continuing our work. In certain rare disease settings, we have seen that raising investor awareness can lead to greater investment, which can help to accelerate new treatments. This year’s symposium aims to build on the success of last year’s event and to continue to foster open and collaborative dialogue among leading experts, companies, researchers, persons with lived experience, caregivers, advocacy organizations, regulators and members of the investment community."
"Real breakthroughs in SCI science require diverse stakeholders to start talking, sharing data and collaborating," said Marco Baptista, Ph.D, Chief Scientific Officer at the Reeve Foundation. "We are focused on propelling the field forward and incentivizing high-risk, high-reward projects that can be translated from the lab into the clinic and make a real impact on quality of life. Success necessitates more collaboration among industry and academia, informed by those with lived experience. We’re excited to again bring together all those who are impacted by SCI and paralysis to explore and learn from promising science in progress."
The 2nd Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 26 and 27, 2024, in the Duane Roth Auditorium at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. This event will bring together both public and private companies developing new treatment options for people with spinal cord injury, alongside leaders in the spinal cord injury medical and advocacy communities. A number of important topics will be discussed, including but not limited to preclinical and clinical SCI treatment approaches and the drug development process; racial, ethnic, socioeconomic, geographic vulnerabilities within SCI care and outcomes; hearing the person's with lived experience voice and ensuring patients' perspectives, needs and priorities are captured in the drug development process; and discussions of SCI clinical endpoints and the need for new and more precise assessment tools.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
About the Sanford Consortium for Regenerative Medicine
The Sanford Consortium is a multi-disciplinary and collaborative community of scientists who share the goal to harness the potential of stem cells for the treatment and cure of human diseases. The Sanford Consortium marshals the intellectual resources of five world leaders in life sciences research: La Jolla Institute for Allergy & Immunology, the Salk Institute for Biological Studies, the Sanford Burnham Prebys Medical Discovery Institute, Scripps Research, and the University of California, San Diego. Each of the Collaborating Organizations has substantive complementary research strengths that combined create a synergistic research enterprise, the whole of which is substantially greater than the sum of its parts. The Collaboratory has served as a focal point for stem cell science and has catalyzed increased collaboration among the stem cell research community. For more information, please visit https://www.sanfordconsortium.com/.
About the Christopher & Dana Reeve Foundation
The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation’s National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community’s voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau’s standards for charity accountability and hold the BBB’s Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/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 effect of the 2nd SCIIS, including accelerating development in SCI, broadening SCI disease awareness, or increasing clinical trial participation; and the ability of cell transplant therapy approaches, including OPC1, to improve recovery or allow a patient to regain more mobility than what could otherwise be expected. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that engagement with patients and the advocacy community may not lead to improvements in patient outcomes; and that raising investor awareness may not lead to greater investment, nor accelerate new treatments; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240318962645/en/
Contacts
Reeve Foundation Media Contact:
Julia Leonard
(mailto://jleonard@reeve.org)
(973) 933-7222
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 -- Scorpius Holdings Accepted as a Member of the US Government’s BioMaP-Consortium
Provides Access to Growth Funding and Enhanced Access to Federal Projects
DURHAM, N.C., March 14, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been accepted into the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), a part of the National Biopharmaceutical Manufacturing Partnership. The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.
The BioMaP-Consortium supports the Biomedical Advanced Research and Development Authority (BARDA) and is comprised of industry partners across the drug and vaccine manufacturing supply chain, including manufacturers of raw materials and consumables, developers of innovative manufacturing technologies, and suppliers of fill finish services. This consortium seeks to expand the industrial and manufacturing base for medical countermeasures to include the requisite capabilities, flexibilities, and strategies to secure needed medical supplies to meet the nation’s public health preparedness and response requirements.
Jeff Wolf, CEO of Scorpius, stated, "We are honored to be accepted as a member of the BioMaP-Consortium, which provides Scorpius opportunities to support biomanufacturing programs focused on the nation’s medical countermeasure programs, while providing biomanufacturing capacity and capabilities to defend against pandemics and other emerging threats. We look forward to building upon our track record of supporting infectious disease and biodefense programs on behalf of BARDA, the U.S. Department of Health & Human Services, and the U.S. Department of Defense.”
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as the Company’s opportunities to support biomanufacturing programs focused on the nation’s medical countermeasure programs, while providing biomanufacturing capacity and capabilities to defend against pandemics and other emerging threats and supporting infectious disease and biodefense programs on behalf of BARDA, HHS and the DoD. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure-play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Study 24 Month Results to Be Featured at 2024 Retinal Cell & Gene Therapy Innovation Summit
CARLSBAD, Calif., March 13, 2024--(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 24 month results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), will be presented at the 2024 Retinal Cell & Gene Therapy Innovation Summit. The meeting will be held May 3, 2024, at the Hyatt Regency Seattle, and is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 24 Results from the Phase 1/2a Trial," will include anatomical and functional data from long-term follow-up in 10 of 12 patients and will be presented by David Telander, MD, PhD, Retinal Consultants Medical Group, on behalf of Roche and Genentech, a member of the Roche Group.
About OpRegen
OpRegen (RG6501) is a suspension of allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in GA by supporting retinal cell health and improving retinal structure and function. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, and 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 the Innovation Summit
The annual Retinal Cell and Gene Therapy Innovation Summit 2024 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. Representatives from the biotech and pharma industries will come together with members of the medical and research communities to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal diseases therapies toward clinical utility. The Summit features presentations by leading retinal disease experts on potential gene and cell-based therapies and how best to deliver them to patients. For more information visit: https://give.fightingblindness.org/event/retinal-cell-and-gene-therapy-innovation-summit-2024/e529485.
About the Foundation Fighting Blindness
The Foundation Fighting Blindness was established in 1971 by a passionate group of families driven to find treatments and cures for inherited retinal diseases that were affecting their loved ones. At that time, little was known about these blinding retinal diseases. Very little research was being done, and there were no clinical trials for potential treatments. Today, the Foundation Fighting Blindness is the world’s leading private funder of retinal disease research. That funding has been a driving force behind the progress toward cures, including the identification of more than 270 genes linked to retinal disease, and the launch of over 40 clinical trials for potential treatments. For more information, visit: https://www.fightingblindness.org/ or follow them on X/Twitter @FightBlindness.
About OHSU Casey Eye Institute
OHSU Casey Eye Institute is a premier academic medical center providing eye care for adults and children in the Pacific Northwest and beyond. Since 1945, OHSU Casey Eye Institute doctors and vision scientists have worked side by side to discover the causes of eye disease and find new treatments. For more information, visit: https://www.ohsu.edu/casey-eye-institute or follow them on X/Twitter: @CaseyEye.
About the OpRegen 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 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 include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of 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 or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; 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/20240313697648/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 -- Scorpius Holdings, Inc. Announces Closing of Public Offering
DURHAM, N.C., March 12, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.15 per share, for gross proceeds of $1,500,000, before deducting underwriting discounts and offering expenses.
The Company intends to use the proceeds from the offering for working capital and general corporate purposes.
ThinkEquity acted as sole book-running manager for the offering.
The offering was made pursuant to an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (the “SEC”), including the base prospectus therein, as supplemented by the final prospectus relating to the offering filed with the SEC on March 11, 2024, all of which are available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004, Attention: Prospectus Department.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 the use of proceed from the offering. Important factors that could cause actual results to differ materially from current expectations include those factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 919 289 4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Provectus Biopharmaceuticals Announces Notices of Allowance and Award for U.S. Patents of Rose Bengal Sodium in Virology, Pediatric Solid Tumor Cancers, and Vaccines
KNOXVILLE, TN, March 12, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (“USPTO”) has allowed patent application 17/212,723, titled “Novel Uses of Halogenated Xanthenes in Oncology and Virology.” The application covers the use of Provectus’s pharmaceutical-grade rose bengal sodium (“RBS”) drug substance for the treatment of infectious diseases, such as coronaviruses.
The USPTO has also allowed patent application 17/344,418, titled “In Vitro and Xenograft Anti-Tumor Activity of a Halogenated-Xanthene Against Refractory Pediatric Solid Tumors.” This prospective award covers the use of RBS in combination with one or more immune checkpoint inhibitors and is a continuation of U.S. patent 11,058,664 (2021), Provectus’s first for pediatric oncology.
The Company’s previously allowed patent application 17/488,430, titled “Halogenated Xanthenes as Vaccine Adjuvants” (December 2023) and covering RBS’s use as an adjuvant in vaccines to potentially make them work better, will be awarded on March 26, 2024 as U.S. patent 11,938,182.
Innovate Calgary, the innovation company of the University of Calgary in Alberta, Canada, is a co-assignee and Aru Narendran, MD, PhD, Professor of Pediatrics, Oncology, Biochemistry and Molecular Biology and Physiology and Pharmacology at the University’s Cumming School of Medicine is a co-inventor on all three patent awards.
About Provectus
Provectus Biopharmaceuticals, Inc. 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. Provectus’s lead HX molecule is named rose bengal sodium.
Provectus’s medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers; and in vitro discovery programs in infectious diseases, tissue regeneration and repair, and proprietary targets.
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:
The Company’s Annual Report on Form 10-K for the period ended December 31, 2022, and
Provectus’s Quarterly Report on Form 10-Q for the period ended September 30, 2023.
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- RG6501 (OpRegen®) Preclinical Engraftment Results to Be Presented at 2024 Association for Research in Vision and Ophthalmology Meeting
CARLSBAD, Calif., March 11, 2024--(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 preclinical results as part of a surgical development study evaluating the survival and distribution of RG6501 (OpRegen) will be presented at the 2024 Association for Research in Vision and Ophthalmology Annual Meeting (2024 ARVO). The meeting will be held May 5-9, 2024, in Seattle, WA. The presentation, "OpRegen engrafts within the retinal pigmented epithelium (RPE) of Gottingen mini-pigs by 4-weeks post-administration via subretinal delivery," will be presented by Rachel N. Andrews, DVM, PhD, DACVP, Principal Scientist-Pathologist, Safety Assessment, Genentech, a member of the Roche Group, on behalf of Roche and Genentech.
About OpRegen[img][/img]
OpRegen (RG6501) is a suspension of allogeneic retinal pigmented epithelial (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 GA by supporting retinal cell health and improving retinal structure and function. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, and 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 the 2024 ARVO Meeting
The ARVO Annual Meeting is the premiere gathering for eye and vision scientists from across the globe, at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions. The theme of the 2024 Annual Meeting addresses how vision research is continually being transformed by new information and technologies. Exponentially expanding computing power is giving rise to improved artificial intelligence and powerful big data. Increasingly sensitive and elegant molecular techniques, including CRISPR and mRNA technologies, as well as more sophisticated imaging modalities, virtual reality, and breakthroughs in gene therapy are catalyzing our research as we aim to treat, cure and ultimately prevent blinding eye diseases. For more information, visit https://www.arvo.org/annual-meeting/meeting-info/meeting-info/ or follow the Association on X/Twitter: @ARVOInfo.
About Geographic Atrophy
GA is an advanced form of 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 or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; 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/20240311914768/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 -- Theriva™ Biologics to Participate in the BIO-Europe Spring Conference
ROCKVILLE, Md., March 11, 2024 (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 Company’s Management will provide a corporate update and participate in one-on-one meetings at the BIO-Europe Spring Conference, to be held in Barcelona, Spain from March 18-20, 2024.
BIO-Europe Spring Conference
Format: Corporate presentation and one-on-one meetings
Presentation Date: Monday, March 18, 2024
Presentation Time: 3:00pm CET
Presentation Location: Room 133/134, Barcelona International Convention Centre (CCIB)
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 -- Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases
A total of 18 patients have been dosed in the trial to date
Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review
AUSTIN, Texas, March 11, 2024 (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 (CNS) cancers, today announced it has completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date. There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1. The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval. In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven. The Company anticipates that this will allow for continued maximal enrollment allowed under the protocol.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for LM and Orphan Drug Designation for the treatment of breast cancer with LM, and the ReSPECT-LM program continues to be funded in part by a 3-year $17.6M 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 direct 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 off target 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 real-time 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 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, including statements regarding clinical trials, expected operations and upcoming developments. 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 “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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 -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., March 08, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $0.15 per share, for aggregate gross proceeds of $1,500,000, before deducting underwriting discounts, commissions and offering expenses. All of the shares of common stock were offered by the Company. The offering is expected to close on March 12, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
The securities were offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-251255), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 10, 2020 and declared effective on December 22, 2020. The offering was made only by means of a written prospectus. A preliminary prospectus supplement and the accompanying base prospectus describing the terms of the offering was filed with the SEC on its website at www.sec.gov. A final prospectus supplement and the accompanying base prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 the timing and completion of the proposed offering. Important factors that could cause actual results to differ materially from current expectations include, among others, the timing of closing of the offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 919 289 4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Scorpius Holdings, Inc. Announces Proposed Public Offering of Common Stock
DURHAM, N.C., March 07, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced that it intends to offer to sell shares of its common stock to the public in an underwritten public offering. All of the shares of common stock are to be sold by the Company.
ThinkEquity is acting as sole book-running manager for the offering.
The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.
The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-251255), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 10, 2020 and declared effective on December 22, 2020. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and the accompanying base prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying base prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference into such preliminary prospectus supplement and the accompanying base prospectus, which provide more information about the Company and such offering
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 the timing and completion of the proposed offering. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 919 289 4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Scorpius Holdings Estimates Greater than 375% Sequential Increase in Revenue for the Fourth Quarter of 2023 Compared to the Third Quarter of 2023
Estimates Sequential Reduction in the Fourth Quarter of 2023 Operating Loss by Over $3.3 Million or Approximately 30% Compared to the Third Quarter of 2023
Achieves Record Backlog of $9.3 Million
DURHAM, N.C., March 07, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc., (“Scorpius”) (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today reported preliminary, unaudited financial results for the fourth quarter of 2023.
Jeff Wolf, CEO of Scorpius, stated, “We are firing on all cylinders and currently estimate our preliminary, unaudited revenue for the fourth quarter of 2023 to be in the range of $3.4 million to $3.6 million, which would represent a greater than 375% sequential increase over the third quarter of 2023. Our contract bookings of over $20 million in 2023 and strong business development efforts in the first quarter of 2024 have produced a record current backlog of $9.3 million. This backlog, along with a strong pipeline of new opportunities, gives us tremendous confidence in our growth trajectory for 2024. In addition, I am pleased to report that we estimate our preliminary, unaudited operating losses for the fourth quarter declined by over $3.3 million, or approximately 30%, compared to the third quarter of 2023, as almost all of our upfront investments in the new facility are now behind us. Most notably, we have built a highly scalable operation, and as revenue continues to grow, we expect to become cash flow positive by early 2025 due to the high incremental margins in our business.”
Mr. Wolf continued, “We are witnessing increasing demand for our state-of-the-art large molecule CDMO services, which has been compounded by the significant shortage of dedicated clinical-scale manufacturing capacity within the industry. Moreover, the large molecule drug substance CDMO market is projected to grow from over $10 billion in 2023 to $21 billion by 20301, highlighting the need for additional industry capacity. Our capabilities, seamless execution, and flexibility to meet the needs of our customers has allowed us to attract premier biopharma and biotech companies, as well as leading research institutions. We typically onboard these customers at the early stages of clinical development, which provides us the opportunity to expand our scope of work as their therapies progress through clinical trials and, ultimately, into full-scale commercial production. Our unique 40,000+ sq. ft. campus, with investments totaling over $65 million to date, provides us sufficient capacity to grow our throughput with minimal additional capex requirements, which we believe is the key to maximizing profits and returns for our shareholders.”
Based upon a preliminary, unaudited review, the Company currently estimates revenue in the range of $3.4 million to $3.6 million for the fourth quarter of 2023. The increase in revenue reflects the completion of contract milestones primarily in the microbial facility and process development work. Additionally, the Company estimates that our operating loss will decline by over $3.3 million, or approximately 30%, as a result of primary completion of qualification and validation processes. The Company expects to report its complete 2023 audited financial results on or before March 28, 2024.
The estimated revenue and operating loss results for 2023 are preliminary and unaudited and are subject to completion of the Company’s financial closing procedures. The Company’s independent registered public accounting firm has not conducted an audit or review of and does not express an opinion or any other form of assurance with respect to, the preliminary unaudited revenue results. It is possible that the Company or its independent registered public accounting firm may identify items that require the Company to make adjustments to the preliminary estimates of revenue and/or operating loss set forth in the press release and those changes could be material. Accordingly, undue reliance should not be placed on the preliminary estimates.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such as preliminary, unaudited revenue for the fourth quarter of 2023 being in the range of $3.4 million to $3.6 million, representing a greater than 375% sequential increase over the third quarter of 2023, operating losses for the fourth quarter declining by over $3.3 million, having tremendous confidence in our growth trajectory for 2024, preliminary, unaudited operating losses for the fourth quarter declined by over $3.3 million, or approximately 30% compared to the third quarter of 2023; our expectation to become cash flow positive by early 2025 due to the high incremental margins in the Company’s business, the large molecule drug substance CDMO market being projected to grow from over $10 billion in 2023 to $21 billion by 2030 highlighting the need for additional industry capacity, expand the Company’s scope of work as our customers’ therapies progress through clinical trials and, ultimately, into full-scale commercial production, the Company’s 40,000+ sq. ft. campus providing it with sufficient capacity to grow its throughput with minimal capex requirements, such capacity being the key to maximizing profits and returns for the Company’s shareholders and reporting the Company’s complete 2023 audited financial results on or before March 28, 2024. There can be no assurance that the Company’s actual full-year 2023 financial and operating results will not differ, perhaps substantially, from the preliminary financial and operating results and expectations contained in this press release. In addition, the Company has not completed its fourth quarter and full-year 2023 closing and review process, and the final results for the full-year 2023 may differ, perhaps substantially, from the statements made in this press release. During the course of preparing the Company’s financial statements and during the review process, management may identify items that would require adjustments that may be material to the amounts described in this press release. In addition, important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed; the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements; regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO; and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this press release is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this press release on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
1 SkyQuest Large Molecule Industry Forecast, February 2024
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript March 5, 2024
Plus Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.7, expectations were $-0.78. PSTV isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2023 Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. 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 and 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 in 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.
Marc Hedrick: Thank you, Victor. Good afternoon, everyone, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2023 full year financial results. And right upfront, apologies for the hoarseness in my voice as I come back from the flu. 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 this afternoon by reviewing our recent clinical and regulatory progress with a focus on the fourth quarter, and then turn the call over to Andrew to review our financials and Dr. LaFrance then will be joining us for Q&A. Let me begin with the updates on our two lead CNS cancer programs.
I think we're in an enviable position in the development of rhenium obisbemeda drug, in that with the recent progress we have made in LM. This effectively means we have two promising lead clinical programs for LM and recurrent GBM. Our ReSPECT-LM Phase 1/2 dose escalation trial of a single administration of rhenium obisbemeda for LM continues to show positive safety and efficacy signals and is making very good progress. In November 2023 at the Society for Neurooncology Meeting, or SNO, we presented results from the [technical difficulty], we showed that 13 patients with LM received a single intraventricular dose of rhenium obisbemeda between 6.6 escalating up to 44 millicuries through an indwelling Ommaya reservoir. No DLTs were observed and the maximum feasible dose was not reached.
The majority of adverse events were mild, 64% Grade 1 or moderate 27% Grade 2. And overall critical organ radiation doses were low. Rhenium obisbemeda circulated throughout the CSF space by one hour following administration and persisted in the CSF for up to seven days, again, with a single administration. CSF [technical difficulty] decreased by up to 91% following rhenium obisbemeda treatment, and the mean reduction was 53%. Seven of 13 treated patients remained alive at the time of reporting, with a median overall survival of 10 months for patients in the first three cohorts. That's cohorts one, two, three. Enrollment is on track to finish the Phase 1 single administration dose escalation trial by year-end 2024 and also along the way to determine a recommended Phase 2 dose for a single administration Phase 2/3 trial.
This assumes complete enrollment through cohort 7 and currently, we anticipate that cohort 7 is likely the max dose. Cohort 4 just completed was the fastest enrollment of all the cohorts to date and cohort 5 is now enrolling. I can tell you that for both the neuro-oncology community at sites, enthusiasm remains very high for this trial, and we have recently onboarded five new clinical trial sites. Later this year, our plan is to meet with the FDA and discuss the potential Phase 2/3 pivotal trial design, assuming the dataset remains positive and continue tolerated development approach focusing on metastatic breast cancer for which we have orphan designation. This would be for a single administration of rhenium obisbemeda. The trial size endpoints and other key trial elements will be discussed later on in the year, but we anticipate substantial financial support for this trial through our award.
In terms of LM data, we anticipate presenting interim safety and feasibility data from the ReSPECT-LM trial at the SNO/ASCO CNS Cancer Conference in August of 2024 and likely updating that for the full Phase 1 at the SNO Annual Meeting in November 2024. We are also currently working to expand the LM trial to accommodate multiple doses to maximize disease impact in the long term. As an aside, patients are requesting additional treatments of rhenium obisbemeda following their first administration in our current trial, so we are increasingly treating more patients with additional doses under compassionate use protocol, which anecdotally seems to be going well from both a safety perspective and the clinical impact, both of which are being closely followed.
We have developed a proposed approach for a multiple dose expansion and anticipate meeting with the FDA in 2024 with the goal of enrollment beginning for dosing expansion in early 2025, if not before. Now let's switch gears a bit, but still within the LM discussion. Please recall that we acquired rights to a highly specific sensitive cerebrospinal fluid tumor cell testing technology in September of 2023. We remain exceptionally encouraged by this test. But as you may recall, the prior company had very significant financial and operating issues. Our rationale for acquiring this was that because it could, A, double the market size for our LM therapeutic because of its significant diagnostic sensitivity improvement over standard-of-care but also it allows for longitudinal disease assessment that is otherwise very difficult or impossible to do with the current standard-of-care in testing.
The update on this test is that we have successfully implemented the test back into our ReSPECT-LM trial, losing only a few patients in cohort 4 as of February 2024. The diagnostic work is being conducted in conjunction with our partner, K2bio in Houston. The assay uses proprietary technology and a broad panel of 18 monoclonal antibodies largely geared towards various adenocarcinomas and melanoma. Working with K2, we can perform the test in a cost-effective manner for our trials and leverage existing grant funding for support. We are in the process of assessing whether broadening the test commercially beyond our trials and our current partnership with K2 is indeed viable. But overall, we continue to think this potential exciting new upside opportunity is great for the company.
Now finally, the ReSPECT-LM Phase 1 program continues to be funded in part through CPRIT, the state of Texas through a three-year $17.6 million product development research award. That continues to go very well. And in September, we received a planned $1.9 million payment followed by a $3.3 million payment this past December as part of the grant contract. To date, we have received approximately $7 million from CPRIT, and we anticipate receiving an additional $6.9 million throughout 2024. And I think Andrew will provide more detail on the CPRIT grant revenue in a moment. Now an update on our ReSPECT-GBM trial of a single dose of rhenium obisbemeda given via convection-enhanced delivery to patients with recurrent glioblastoma or GBM. ReSPECT-GBM continues to enroll patients, and we are actively adding new clinical trial sites.
Until recently, we have been limited in terms of trial sites based on the NCI NIH grant funding award, which has substantially supported this trial through the principal investigator, Dr. Andrew Brenner and the University of Texas. Going forward, in 2024, we will expand trial sites, more efficiently interface with sites and provide broader and more direct corporate support for the trial. We are incredibly grateful for the five-year support from the NCI University of Texas and the trial PI, up to this point, as we take the ball and move the trial from Phase 2 to a pivotal trial. We anticipate adding a total of five to eight new sites this year, which is currently ongoing, and we think that's going to provide a strong starting basis for a pivotal trial commencing in 2025.
The impact of those sites of enrollment will be felt in the latter part of 2024, and we hope to complete Phase 2 enrollment in late 2024 or early 2025. Last November, we presented initial positive safety and feasibility data from the Phase 2 ReSPECT-GBM trial at the SNO meeting last November. As a reminder, the primary endpoint of that Phase 2 is to assess overall survival following a single dose of rhenium obisbemeda in recurrent GBM and compare that to standard-of-care. In summary, that data showed median overall survival in the 15 patients from the Phase 2 study treated at that time was 13 months median overall survival, 13 months versus approximately eight months for the standard of care, and nine of the 15 patients remained alive at the time of the analysis.
Median progression-free survival was 11 months compared to bevacizumab, which is 3.4 months. Rhenium obisbemeda continues to demonstrate a very favorable safety profile despite delivering up to 20x the dose of radiation that is typically delivered by external beam radiation therapy for GBM, and that's typically around 35 gray and we've gone up to 740 gray and the mean dose we're giving now is about 300 to 350 gray. In 13 of 15 patients or 86% of patients have thus far met the empirically derived rhenium obisbemeda dosing target threshold that we've established in Phase 1 and in preclinical studies of greater than 100 gray average absorbed dose to the tumor in greater than 70% tumor coverage. The Phase 2 trial performance in terms of median overall survival will be controlled in the Phase 2 using real-world data generated in conjunction with our partner metadata who has a sizable database in GBM in a history of using that successfully in GBM trials with the FDA.
In the Phase 1, with metadata, we conducted two real-world data trials in our GBM and one versus bevacizumab monotherapy and another versus other convection-enhanced delivery trials that were propensity matched to our Phase 1 data. In those two trials in terms of median overall survival, that was aligned with the recent meta-analysis showing current standard-of-care in recurrent GBM in terms of median overall survival is approximately eight months. And so currently, we view that as an effective clinical hurdle rate, if you will, in a Phase 2 and in a pivotal. So comparing our Phase 2 data as it stands to - as of November of last year versus real-world data, that's the last time we reported data, a median overall survival, as a reminder, was 13 months, which is 63% better than current standard-of-care which is bevacizumab monotherapy, for example, that has - carries an overall survival of approximately eight months.
Also, I'd like to highlight another presentation of our imaging data that was also presented at the same meeting in November by the trial PI. Imaging is an important secondary endpoint in the trial, supporting the overall survival signal. It has until recently been difficult to assess because pseudo progression has been commonly noted in patients that are receiving such a high dose of radiation, namely 10x to 20x over EBRT. It was a very technical presentation and can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI and T1 T2-weighted images, using things such as relative cerebral blood volume, treatment response assessment maps and fit books, we can increasingly, if not reliably delineate pseudoprogression from progression as well as better understand patterns of recurrence, and we think this is going to help ensure that we are able to more rapidly develop and improve upon this novel new therapy for GBM, but also adapted for primary GBM and other brain cancers in children and adults.
And related to that point above, I thought it might be useful for me to take a couple of minutes and do a little bit of a forward-looking reframe of this GBM development program that we've been working on and look at it in sort of a unique way based on what we've learned over the last over three years of development. In my view, what we've developed is not - it's not ideal to think about this as sort of a pure-play GBM drug therapeutic per se. But rather, I think it's more accurate to think about this as a novel targeted radiotherapeutic delivery ecosystem that can overcome not just the limitations of external beam radiation therapy, which is the mainstay of GBM therapy. In other words, we've increased by 10x to 20x the amount of absorbed radiation dose over EBRT.
But when you couple that with the state-of-the-art imaging, the custom treatment planning with specific software that's now available, the neuronavigational technology and convection-enhanced delivery catheters that are optimized, we can also overcome the limitations of blood brain barrier that makes drugging GBM a very challenging matter and also overcome the limitations of the aggressive local invasiveness that is well known with GBM, which makes complete surgical resection almost impossible. So given the safety margins that we have seen thus far, with only a single administration of the radiotherapeutic drug and using the convection-delivery modality, we see tremendous opportunity and potential in both improving upon the standard-of-care in radiation delivery for GBM, which is EBRT in general but also improve upon current standard approaches for recurrent GBM such as surgery and chemotherapeutics and then expanding into other CNS tumor types of the brain parenchyma.
And I'm happy to discuss this more in the Q&A session. Now in terms of data, we anticipate an update at SNO in November 2024. We also intend to meet with the FDA in 2024, both on the GBM pivotal trial design and to obtain FDA IND approval to begin enrollment of the ReSPECT pediatric brain cancer trial for children with high-grade glioma and ependymoma. To meet our clinical goal of being in pivotal trials in 2025 with rhenium obisbemeda drug, we are focused in 2024 to expand our GMP manufacturing relationships, such that we have two fully validated manufacturers that can support primary drug supply, backup drug supply, scale-up activities and all foreseeable commercial demand forecast. So relatedly, we are working to build in redundancy in all supply chain intermediaries, including radioisotope target and radiation services.
We think rhenium is an exciting new clinically relevant radioisotope and interest in that is very high. We are currently on track to meet both of these important drug production supply objectives. In terms of building out the pipeline, we are focusing on two discrete areas. Our new radiotherapeutic, which is rhenium nanoliposome biodegradable alginate microsphere long term, but we call it RNL BAM and building on our organizational expertise and success in obtaining nondilutive grant funding. First, as it relates to RNL BAM, as a reminder, this is a next-generation radioembolic device as it's now designated by the FDA as of last year, which is designed to treat a variety of solid organ tumors. As the FDA path is now resolved, we are analyzing key device design attributes that we think will ensure this is an attractive product for both liver cancer and other cancers, and we'll provide more updates as that develops over the year.
Second, as to the issue of grants. We currently have over $20 million in active awarded funding for our two lead programs in LM and GBM. In 2023, we filed for approximately $7 million in grant funding and plan to increase that to at least $10 million in 2024. As per our practice, we report on specific grant funding only when awarded. Now with that update, I'll turn the call over to our CFO, Andrew Sims, who will review the financials. Andrew?
Andrew Sims: Thank you, Marc, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31, 2023. As of December 31, 2023, cash and cash equivalents were $8.6 million compared to $18.1 million as of December 31, 2022. We are projected to receive an additional $6.9 million in grant funding from CPRIT in 2024, with $3.3 million in the first half of 2024, and a balance of $3.6 million by the end of the year. In addition, as Marc mentioned, the company continues to benefit from grant awards of $3 million from the NIH to support the GBM trial through Phase 2. Based on the cash on hand and committed grant funding, our current balance sheet provides runway into the second half of 2025.
The company recognized $4.9 million of grant revenue during the year ended December 31, 2023, compared to $0.2 million in 2022, reflecting the progress made on the LM indication in 2023. We expect grant revenue will continue to increase during 2024 and the remaining term of the CPRIT grant through August 2025 as we plan to expand the LM clinical trial to add clinical sites and enroll additional patients. Total operating expenses for the year ended December 31, 2023 of $18.2 million compared to $19.7 million in the same period 2022. The decrease due to lower professional and legal expenses. Other income increased from $147,000 in 2022 to $400,000 in 2023 and fully offset interest expense. As a result of these changes, the net loss decreased by $6.9 million from $20.3 million in the year ended December 31, 2022, to $13.3 million in the year ended December 31, 2023.
And now I'll turn it back to you, Marc.
Marc Hedrick: Great. Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on selected key milestones anticipated over the next 12 months. First, we had safety and efficacy data from the Phase 1 ReSPECT-LM trial with the SNO/ASCO CNS meeting in August of 2024 and likely further update at the full-on SNO meeting in October 2024. We anticipate completing the Phase 1 trial in LM by the end of 2024, and we're on track [technical difficulty] conjunction develop a Phase 2/3 pivotal trial design for breast cancer patients with LM in conjunction with the FDA. We will also be working with the FDA in 2024 to develop a multiple dosing approach to potentially further extend tumor impact of the rhenium obisbemeda and leptomeningeal patients.
In our GBM program, we intend to expand trial sites, as mentioned, and complete enrollment in the Phase 2 trial by late 2024 or early 2025 and in parallel finalized pivotal trial design planning with the FDA that's partially done at this point. Pending IND clearance from the FDA, we intend to initiate the Phase 1 pediatric brain cancer trial for pediatric brain cancer patients. And we also plan to bolster our rhenium obisbemeda supply chain for commercial readiness in 2024 as well as complete device development optimization milestones for our next-generation radioembolic device, RNL BAM. Now with those key milestones, I'll turn the call back over to Victor to introduce any questions we might have. Victor?
To continue reading the Q&A session, please click here.
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of Cancer Immunotherapy PV-10 Abstract for HNSCC at AACR 2024 Annual Meeting
KNOXVILLE, TN, March 07, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that data from preclinical research on PV-10 (rose bengal sodium) for the treatments of human papillomavirus (“HPV”)-positive and HPV-negative head and neck squamous cell carcinoma (“HNSCC”) will be presented at the upcoming annual meeting of the American Association for Cancer Research (“AACR”), to be held April 5-10, 2024 in San Diego, California.
The abstract, which was accepted for a poster presentation, is titled “PV 10 induces endoplasmic reticulum stress and autophagy, triggering immunogenic cell death and anti-tumor immunity in head and neck squamous cell carcinoma” (Abstract #6742, Topic Track: Immunology, Session: Vaccines, Antigens, and Antigen Presentation 2).
The work underlying this poster presentation is part of research conducted by Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology and Program Leader of Head and Neck Oncology and members of the Chung laboratory at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida.
According to Moffitt’s abstract, “…in vitro findings reveal that PV-10 induces cytotoxicity in both mEER and MTE-RAS cells. Notably, PV-10 promotes a significant increase in [reactive oxygen species], leading to an elevation in late apoptotic cells. Markers of immunogenic cell death (ICD), including a statistically significant increase in the release of damage-associated molecular pattern molecules HMGB1 and ATP, as well as enhanced surface expression of calreticulin, HSP-70, and HSP-90, were observed. At the molecular level, a remarkable activation of endoplasmic reticulum (ER) stress, pro-apoptotic protein, and autophagy markers were observed. Intratumoral PV-10 injection in vivo has shown significant tumor regression in both mEER and MTE-RAS tumors, and a complete response was noticed in some mice, indicating that PV-10 induces potent ICD in both mEER and MTE-RAS tumors.”
About Provectus
Provectus Biopharmaceuticals, Inc. 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. Provectus’s lead HX molecule is named rose bengal sodium.
Provectus’s medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers; and in vitro discovery programs in infectious diseases, tissue regeneration and repair, and proprietary targets.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, ClinicalTrials.gov. For additional information about Provectus, please visit the Company’s website at https://www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: The information provided in this press release may include forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events 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. Such statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are often, but not always, identified by the use of words such as “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of Provectus’s drug agents and/or their 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 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 the Company undertakes no obligation to update or revise any forward-looking statements, whether because 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, including those described in Item 1A of:
The Company’s Annual Report on Form 10-K for the period ended December 31, 2022, and
Provectus’s Quarterly Report on Form 10-Q for the period ended September 30, 2023.
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Oncolytics Biotech® Files Amendment to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN
US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab
Testing with the most common therapies could facilitate broad use of pelareorep in pancreatic cancer patients
SAN DIEGO and CALGARY, AB, March 5, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany's regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. Evaluation of this novel treatment approach will complement Oncolytics' ongoing development of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in PDAC, which is expected to advance to a registrational study later this year.
"We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy1. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible."
Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the reasons for pancreatic cancer's poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME)2. Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer."
"This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN's strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study."
References
1. Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453.
2. Yoon JH, et al. Immunotherapy for pancreatic cancer. World J Clin Cases. 2021 May 6;9(13):2969-2982. doi: 10.12998/wjcc.v9.i13.2969. PMID: 33969083; PMCID: PMC8080736.
About GOBLET cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm - pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen patients may be randomized to each arm in Stage one of the Simon-two stage design. The co-primary endpoints of the cohort are objective response rate and safety. The success criteria for Stage 1 is defined as six or more responses in one or both of the treatment groups. Successful completion of Stage one will support expansion into Stage two, which can include one or both treatment regimens, and would enroll 17 additional evaluable patients. A total of 13 or more responses from Stage 1 and 2 combined are required to achieve the success criteria. Translational data will also be generated.
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) and/or disease control rate 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 five treatment groups:
1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
5. Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
Any cohort meeting pre-specified efficacy criteria 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, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
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 Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; our belief that pelareorep in combination with mFOLFIRINOX could improve outcomes for pancreatic cancer patients and advance the development of new treatment options for patients with pancreatic cancer; our plans to build on PanCAN's strong relationships with the pancreatic cancer community and further our collaboration with AIO-Studien-gGmbH on our GOBLET study; our plans to advance towards registrational studies 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). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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NEWS -- Tokens.com Completes Sale of Assets to StoryFire
TORONTO, March 04, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to announce that it has successfully closed the sale of Metaverse Group and Hulk Labs to StoryFire as scheduled on March 1, 2024.
The final agreement was closed with consideration to Tokens.com for the disposition consisting of a 15.3% equity interest in StoryFire, valued at US$3.5 million, plus US$500,000 in Blaze tokens, the in-app currency native to StoryFire. In addition, Tokens.com will be represented by Andrew Kiguel on the board of StoryFire.
"We are pleased with the successful completion of this sale, and look forward to the continued disruptive innovation and impact our new partners at StoryFire will bring to the web3 space," said Andrew Kiguel, CEO of Tokens.com.
StoryFire is a private online social entertainment and gaming platform that empowers users to create and engage with immersive narratives. With a rapidly growing user base of 2.5 million, StoryFire offers a vibrant and creative community for storytellers and enthusiasts. StoryFire users create social posts akin to Twitter, gain a following and earn an in-app currency known as Blaze. StoryFire is a privately owned entity.
About Tokens.com
Tokens.com is a technology holding company that also owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240304232814/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Tokens.com Completes Sale of Assets to StoryFire
TORONTO, March 04, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to announce that it has successfully closed the sale of Metaverse Group and Hulk Labs to StoryFire as scheduled on March 1, 2024.
The final agreement was closed with consideration to Tokens.com for the disposition consisting of a 15.3% equity interest in StoryFire, valued at US$3.5 million, plus US$500,000 in Blaze tokens, the in-app currency native to StoryFire. In addition, Tokens.com will be represented by Andrew Kiguel on the board of StoryFire.
"We are pleased with the successful completion of this sale, and look forward to the continued disruptive innovation and impact our new partners at StoryFire will bring to the web3 space," said Andrew Kiguel, CEO of Tokens.com.
StoryFire is a private online social entertainment and gaming platform that empowers users to create and engage with immersive narratives. With a rapidly growing user base of 2.5 million, StoryFire offers a vibrant and creative community for storytellers and enthusiasts. StoryFire users create social posts akin to Twitter, gain a following and earn an in-app currency known as Blaze. StoryFire is a privately owned entity.
About Tokens.com
Tokens.com is a technology holding company that also owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240304232814/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Thursday, March 7, 2024, at 4:30 p.m. ET
SAN DIEGO and CALGARY, AB, March 4, 2024 /CNW/ -- 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 Thursday, March 7, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2023.
Conference Call & Webcast
Date: Thursday, March 7, 2024
Time: 4:30 p.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): 6244-5815
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 445-815#.
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, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-recent-operational-highlights-302078051.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/March2024/04/c8901.html
NEWS -- Lineage Cell Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results and Provide Business Update on March 7, 2024
Business Wire
CARLSBAD, Calif., February 29, 2024--(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 fourth quarter and full year 2023 financial and operating results on Thursday, March 7, 2024, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, March 7, 2024, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on March 7th, 2024, 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 March 14, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 8345585.
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 www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229203493/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of Pharmaceutical-Grade Rose Bengal Sodium Abstract for Poster Presentation at 2024 Society for Investigative Dermatology (SID) Annual Meeting
NEWS -- Tokens.com Provides Crypto Inventory Update
TORONTO, February 29, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN | Frankfurt Stock Exchange: 76M | OTCQB: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to share an update on its cryptocurrency holdings.
Below is a table showing our current crypto ownership and corresponding value as of noon EST on February 28, 2024. All dollar figures are in United States dollars ("USD"), unless otherwise stated.
In addition to its cryptocurrency inventory below, the Company holds approximately $2.5 million (CAD$3.5 million) in cash, a portfolio of valuable crypto domain names, and subsequent to a closing date of March 1, 2024, a 15.3% interest in StoryFire Inc.
*340 Ethereum are held by Genesis Global Trading.
**18,001 Solana are held by Genesis Global Trading.
*** Subject to closing the sale of certain assets to StoryFire Inc. on March 1st, 2024.
**** Based on basic common shares outstanding as at February 28, 2024 of 119,761,592.
The company 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. Management is confident, however, that it will be able to recover the majority of its assets from Genesis based on recent disclosure by Genesis. In addition, claims held by those with deposits at Genesis, such as Tokens.com, are selling in the open market for over 90% of their implied value.
About Tokens.com
Tokens.com is a technology holding company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240229325527/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Tokens.com Provides Crypto Inventory Update
TORONTO, February 29, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN | Frankfurt Stock Exchange: 76M | OTCQB: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to share an update on its cryptocurrency holdings.
Below is a table showing our current crypto ownership and corresponding value as of noon EST on February 28, 2024. All dollar figures are in United States dollars ("USD"), unless otherwise stated.
In addition to its cryptocurrency inventory below, the Company holds approximately $2.5 million (CAD$3.5 million) in cash, a portfolio of valuable crypto domain names, and subsequent to a closing date of March 1, 2024, a 15.3% interest in StoryFire Inc.
*340 Ethereum are held by Genesis Global Trading.
**18,001 Solana are held by Genesis Global Trading.
*** Subject to closing the sale of certain assets to StoryFire Inc. on March 1st, 2024.
**** Based on basic common shares outstanding as at February 28, 2024 of 119,761,592.
The company 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. Management is confident, however, that it will be able to recover the majority of its assets from Genesis based on recent disclosure by Genesis. In addition, claims held by those with deposits at Genesis, such as Tokens.com, are selling in the open market for over 90% of their implied value.
About Tokens.com
Tokens.com is a technology holding company that owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240229325527/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Oncolytics Biotech® Announces Presentation at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference
PR Newswire
SAN DIEGO and CALGARY, AB, Feb. 28, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that Chief Executive Officer Dr. Matt Coffey will present a corporate overview at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference. The conference is taking place from February 29 - March 2, 2024, at the Ritz Carlton Hotel in New Orleans, LA. Additional details on the presentation can be found below.
Date: Friday, March 1, 2024
Time: 11:30 a.m. ET
Location: Ritz Carlton Hotel New Orleans, Acadia Room 2nd Floor
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request to the conference organizers or email mailto://jpatton@oncolytics.ca
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK).
Additional information about the event can be found on the official website by clicking here.
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, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
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 to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-presentation-at-the-cancer-advocacy-group-of-louisianas-3rd-annual-neauxcancer-conference-302074097.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Tokens.com Management Team Acquires Common Shares in Open Market
TORONTO, February 28, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to share that certain members of its senior management team have purchased an aggregate of 500,000 common shares on the open market, between February 22, 2024 and February 27, 2024.
Andrew Kiguel, CEO, acquired 300,000 common shares, bringing his total ownership of common shares to 15,965,000. Martin Bui, CFO, acquired 170,000 common shares, and Jennifer Karkula, Head of Communications, acquired 30,000 common shares.
"Management believes that the intrinsic value of the Tokens.com shares has been overlooked by the market. Management believes in the potential of our Company," said Andrew Kiguel, CEO of Tokens.com. "Our management team shares this conviction, evident in their decision to bolster their stake by purchasing additional common shares. We are excited by the near-term and long-term growth prospects of the Company."
In November 2023, Tokens.com commenced a strategic review, which, among other things, precipitated the recent sale by the Company of the assets comprising the Metaverse Group and Hulk Labs. The board of directors and the senior management team of the Company remain actively engaged in exploring several possible transactions with a view to propeling the business forward and enhancing shareholder value.
About Tokens.com
Tokens.com is a technology holding company that also owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240228353475/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Tokens.com Management Team Acquires Common Shares in Open Market
TORONTO, February 28, 2024--(BUSINESS WIRE)--Tokens.com Corp. (Cboe Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or the "Company"), a technology holding company that owns an inventory of cryptocurrencies, is pleased to share that certain members of its senior management team have purchased an aggregate of 500,000 common shares on the open market, between February 22, 2024 and February 27, 2024.
Andrew Kiguel, CEO, acquired 300,000 common shares, bringing his total ownership of common shares to 15,965,000. Martin Bui, CFO, acquired 170,000 common shares, and Jennifer Karkula, Head of Communications, acquired 30,000 common shares.
"Management believes that the intrinsic value of the Tokens.com shares has been overlooked by the market. Management believes in the potential of our Company," said Andrew Kiguel, CEO of Tokens.com. "Our management team shares this conviction, evident in their decision to bolster their stake by purchasing additional common shares. We are excited by the near-term and long-term growth prospects of the Company."
In November 2023, Tokens.com commenced a strategic review, which, among other things, precipitated the recent sale by the Company of the assets comprising the Metaverse Group and Hulk Labs. The board of directors and the senior management team of the Company remain actively engaged in exploring several possible transactions with a view to propeling the business forward and enhancing shareholder value.
About Tokens.com
Tokens.com is a technology holding company that also owns an inventory of cryptocurrency 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 Twitter, LinkedIn, Facebook, Instagram 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/20240228353475/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
Email: mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on March 5, 2024
AUSTIN, Texas, Feb. 27, 2024 (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 fourth quarter and full year 2023 financial results on Tuesday, March 5, 2024, 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, March 5, 2024 @ 5:00 PM ET
Dial-in Link: https://register.vevent.com/register/BIa3e26b40a05b4e7185cb3d97450dd3c4
Webcast: https://edge.media-server.com/mmc/p/p7t4p29q
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 -- Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q1 2024 Earnings Call Transcript
Provectus Biopharmaceuticals, Inc. (PNK:PVCT) Q1 2024 Earnings Call Transcript February 22, 2024
Provectus Biopharmaceuticals, Inc. isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Thank you for standing by. This is the conference operator. Welcome to the Provectus Biopharmaceuticals First Quarter 2024 Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. I would now like to turn the conference over to Alyssa Barry, irLabs Investor Relations. Please go ahead.
Alyssa Barry: Thank you, operator. Good afternoon. Welcome to the first quarter 2024 conference call of Provectus Biopharmaceuticals, which is developing immunotherapy medicines for cancer and other diseases. My name is Alyssa Barry, Co-Founder and Principal of investor relations firm irLabs. I am hosting today’s call. Ed Pershing, Chairman of Provectus’ Board of Directors, and Dominic Rodrigues, Board Vice Chairman, will provide company updates and their remarks. First, Nathan Kibler, Provectus’ Outside Legal Counsel from the law firm of Baker Donelson, will read the company’s forward-looking statements.
Nathan Kibler: Thank you, Alyssa. The information provided on this conference call may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events 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 aim, likely, outlook, seek, anticipate, budget, plan, continue, estimate, expect, forecast, may, will, would, project, projection, predict, potential, targeting, intend, can, could, might, should, believe, and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of Provectus’ drug product candidates and/or their uses under investigation have not been established. There is no guarantee that these 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 revenue levels. Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, listeners should not place undue reliance on these forward-looking statements. The forward-looking statements discussed on this conference call are made as of the date hereof or as of the date specifically specified herein, and the company undertakes no obligations to update or revise any forward-looking statements, whether because 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 Provectus’ filings with the U.S. Securities and Exchange Commission, including those described in Item 1A of the company’s Annual Report on Form 10-K for the period ended December 31, 2022, and Provectus’ quarterly report on Form 10-Q for the period ended September 30, 2023.
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NEWS -- Provectus Biopharmaceuticals Announces First Quarter 2024 Conference Call
KNOXVILLE, TN, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that it will host a conference call starting at 3 p.m. EST on Thursday, February 22, 2024, to provide Company updates.
The conference call may be accessed by registering in advance or dialing 1-800-319-4610 (in the U.S.) or 1-604-638-5340 (outside the U.S.). Please dial in approximately five minutes prior to the start of the call.
About Provectus
Provectus Biopharmaceuticals, Inc. 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. Provectus’s lead HX molecule is named rose bengal sodium.
Provectus’s medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers; and in vitro discovery programs in infectious diseases, tissue regeneration and repair, and proprietary targets.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, 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 the Private Securities Litigation Reform Act of 1995, relating to the business of Provectus and its affiliates, which are based on currently available information and current assumptions, expectations, and projections about future events 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 “aim,” “likely,” “outlook,” “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “would,” “project,” “projection,” “predict,” “potential,” “targeting,” “intend,” “can,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.
The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.
Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.
Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the Securities and Exchange Commission (SEC), including those described in Item 1A of:
The Company’s Annual Report on Form 10-K for the period ended December 31, 2022, and
Provectus’s Quarterly Report on Form 10-Q for the period ended September 30, 2023.
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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Provectus Biopharmaceuticals Engages irlabs for Investor Relations Services
KNOXVILLE, TN, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that it has engaged IR Labs, Inc. (“irlabs”) to develop a comprehensive investor relations and corporate communications program for the Company.
Ed Pershing, Chairman of Provectus’s Board of Directors said, “We are pleased to have irlabs and Alyssa Barry join our team as we seek to increase Provectus’s investor communication and engagement and expand the Company’s visibility and outreach to the investment community.”
“Provectus is a great fit for irlabs and we are excited to help the Company increase its visibility and engagement with retail and institutional investors," said Alyssa Barry, Co-Founder and Principal at irlabs.
About Provectus
Provectus Biopharmaceuticals, Inc. 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. Provectus’s lead HX molecule is named rose bengal sodium.
Provectus’s medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo development programs in oncology, hematology, full-thickness cutaneous wound healing, and canine cancers; and in vitro discovery programs in infectious diseases, tissue regeneration and repair, and proprietary targets.
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:
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Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999