Developing the Clinic of the Future, Cloud DX work to be supported by Sheridan College through federal grant
News in Summary
Cloud DX (TSXV:CDX) (OTC:CDXFF), a leading Virtual Care platform, announces the issuance of a new patent for its upcoming Pulsewave 2.0 Vital Sign Monitor. The wrist-worn device stands to be the first at home clinical-grade vital signs monitor to capture diagnostic-quality blood pressure, heart rate, heartbeat irregularities, and respiration status simultaneously. This is the second patent for the Pulsewave 2.0 platform and this award arrives during the company's record-breaking quarter.
US patent 11,272,859 entitled ‘System and Method of Determining Respiratory Status From Oscillometric Data', strengthens the protection of Cloud DX's innovative and novel methods used to determine respiratory status. Building upon the device's initial US patent 11,006,843,which depicts the concept of using oscillometric data to determine respiration rate. This patent protects the methods developed to analyze data in determining respiratory status, beyond just respiratory rate. The company congratulates inventors Vesal Badee, Sara Ross-Howe, Josh Haid, Lamiaa Amzil, Cezar Morun, and Bonghun Shin, all members of the Research and Development team at Cloud DX.
Lead inventor and Cloud DX Biomedical Data Scientist, Vesal Badaee, states "There are plenty of digital health wearables in the market. Most, however, are limited in the quality of data they provide. This can frustrate doctors and healthcare professionals when users want to rely on them. In medicine, clinical-grade vitals are required for diagnostics or medical direction; Cloud DX is driving the transition in bringing clinical-grade wearables into the consumer space, from hospitals and clinics to our homes. This second patent on our next-generation Pulsewave underlines the innovation we're producing at Cloud DX. The team and I are proud to be a part of this Virtual Care transition."
"With the Medical Metaverse and the Virtual Care movements growing the need for home-based diagnostics grows ever more prominent," added Robert Kaul, CEO and Founder of Cloud DX. He continued, "Together these technologies create an all-encompassing model of care improves access to healthcare and can expedite accurate clinician decision making. The ability to accurately capture patient vitals anywhere in the world, even in most remote locations, and transfer that data directly to their doctor or care team means primary care teams can make better clinical decisions, potentially remove the need for an in-person doctor visit, or even circumvent an emergent care visit. To put it simply, the connected ecosystem means better patient outcomes, closer circles of care, and more economical for providers and payers."
How Pulsewave 2.0 breathing rate technology works
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Click here to connect with Cloud DX (TSXV:CDX) (OTC:CDXFF) to receive an Investor Presentation
Developing the Clinic of the Future, Cloud DX work to be supported by Sheridan College through federal grant
News in Summary
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), leading Virtual Care platform provider, will partner with Sheridan College (the grant recipient) on a project with Cloud XR, the company's eXtended Reality division, to further develop the Clinic of the Future, an augmented reality (AR) platform. This is made possible through the support of a Natural Sciences and Engineering Research Council (NSERC) Applied Research and Technology Partnership (ARTP) non-dilutive funding grant. As a key industry partner, Cloud DX will work with Sheridan College who will conduct a portfolio of applied research projects in Mobile Health and Health and Machine Learning
Cloud XR's Clinic of the Future demonstrates how its patented Vitaliti™ continuous monitoring device displays real-time patient information in the form of 3-D holographic images. The Clinic of the Future is the Medical Metaverse in action, a fully remote, touchless, seamless method enabling healthcare professionals to interact with patients.
Dr. Sonny Kohli, Chief Medical Officer and Co-Founder at Cloud DX states: "Improving healthcare is important to everyone, we all use it throughout our lives, and advancement in healthcare and medicine is only possible through innovation. Working with partners such as Sheridan's Center for Mobile Innovation is essential to push the industry into the future. At Cloud DX working with leaders such Dr. Edward Sykes helps bring our inventions to life and supports our commercialization of new healthcare devices, such as our patented Vitaliti™. This NSERC funding not only recognizes Canadian technology leadership like our partnership, more importantly it advances the MedTech industry - one where virtual and remote care, AI, and Augmented Reality are embedded throughout; the Medical Metaverse. Think about it, a leading specialist can now examine a patient on the other side of the world, its limitless. The Medical Metaverse will improve access to healthcare, create more efficiencies, lead to better patient outcomes, and much more."
About the Sheridan Centre for Mobile Innovation
The Sheridan Centre for Mobile Innovation (CMI) creates innovative solutions to industry-relevant challenges, in close collaboration with industry, community, and academic partners. CMI uses leading technologies in its research including: mobile, Artificial Intelligent/Machine Learning/Deep Learning, wearable computing, augmented/virtual reality/mixed reality and Internet of Things. Please visit: cmi.sheridancollege.ca. For more information on research and innovation at Sheridan, please visit research.sheridancollege.ca.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX chosen as Virtual Care Platform for the Ontario Paramedical Service provider, replacing existing hardware and services
Cloud DX (TSXV:CDX)(OTCQX:CDXFF) is pleased to announce a new 24-month contract with an Ontario Paramedic Service Provider enabling the client to provide Remote Patient Monitoring (RPM) across its serviceable area. Cloud DX will provide its award-winning Connected Health™ platform and support the client as it transitions from its previous remote care tools to Cloud DX's Virtual Care Platform. The client showcases how beneficial ‘Remote Care Monitoring' is for Paramedical Service providers, enabling providers to establish deeper community roots and maintain funding levels, while community members benefit from greater access to much-needed care. The client has purchased 223 Connected Health™ kits totalling ~$145,000 CAD with additional recurring fees for subscription software services. Funding for the program comes from the $82.5M Community Paramedicine for Long-Term Care program announced by the Ontario government on October 22, 2021
The Paramedical client will provide Cloud DX's biometric monitoring equipment to clients in their homes to monitor vital signs including weight, blood pressure, heart rate, oxygen level, temperature, and blood glucose. Daily monitoring allows the client and health care providers to make informed decisions and enables the Paramedic to connect with the client if a metric is out of range. The paramedical care provider seeks to keep individuals on the long-term care bed waitlist and individuals who are medically complex or isolated comfortable and safe in their homes. In turn, Remote Care Monitoring is expected to reduce 911 calls, emergency room visits, and hospital admissions.
Cloud DX COO and co-founder, Anthony Kaul, states "At-home remote monitoring is critical to improving the health of vulnerable populations, such as community members with chronic conditions or seniors who wish to live independently for as long as possible. By bringing Remote Care Monitoring directly to the community our client is forging a new path in paramedicine. This modern approach improves community health and enables significantly earlier intervention for those with deteriorating health, in turn reducing hospitalizations. Cloud DX is well known for our high user satisfaction ratings, so we are confident this initiative will be well received by the community. Of course, with our Headquarters in Ontario, we're always extremely happy to support our neighbouring communities."
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Continued growth in US RPM as partner Maxwell Telecare signs two additional clinics in Illinois
News in Summary
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), Cloud DX, a leading Virtual Care platform in North America, and partner Maxwell Telecare announce two additional new contracts with US based Primary Care practices in Illinois. Under the company's Patient First™ program, the clinics will deploy Connected Health™ to control exacerbations, improve quality of life, and avoid hospital admissions, and ER visits. The participating Maxwell clinics will prescribe the kits under US codes for reimbursed Remote Patient Monitoring and Chronic Care Management, paid for by public and private health insurance. This announcement contributes to a record-setting quarter for Cloud DX bringing the total signed contracts this quarter to 12
Rajani Nair, Deployment Manager at Cloud DX, states "Maxwell Telecare understands the value of RPM and how it improves not only a clinic's return on investment but more importantly improves patient care and patient outcomes. As deployments across their network scale, the Maxwell team seamlessly integrates our Connected Health™ kit as part of their patient offerings, reimbursable in the US for RPM or Chronic Care Management. Given their ease of integration, this partnership has transitioned from establishment to scaling. We look forward to continuing to work with them"
Footnotes:
1. Hajat, C., & Stein, E. (2018). The global burden of multiple chronic conditions: A narrative review. Preventive medicine reports, 12, 284-293. https://doi.org/10.1016/j.pmedr.2018.10.008
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner of Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
News Provided by ACCESSWIRE via QuoteMedia
Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
Healthcare team to use Connected Health™ kits to provide dignity in care for up to 85 patients
News in Summary
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading Virtual Care platform, signs a contract with a healthcare team in Niagara, Ontario, Canada. The team will use Cloud DX's Connected Health™ kits and software services for up to 85 palliative patients. The 12-month contract will commence deployment this month, adding to Cloud DX's successful quarter and recently announced, industry first patent in vital-sign analysis. Connected Health™ has been deployed for palliative patients by other provinces and territories, including Yukon Health and Social Services, since 2019
"While we're known for our post-surgical and chronic care programs, it is refreshing to work with clinics who are passionate about the extended benefits and applications of RPM. This healthcare team understands RPM and recognizes its many use cases," says Head of Operations, Cara MacDonald. "Making healthcare better means encompassing all stages of life, all stages of illness or conditions. We look forward to paving the palliative healthcare delivery pathway with a clinical leader in Ontario."
Palliative Care Management is the third focus area for Cloud DX, building upon its growing Post-Surgical and Chronic Care Management programs. As the digital healthcare sector grows globally, the company continues to work with care providers to pursue new use cases for virtual care and remote patient monitoring while innovating new care pathways alongside industry-leading partners such as Medtronic Canada and Equitable Life.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
News Provided by ACCESSWIRE via QuoteMedia
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading North American provider of virtual care and Remote Patient Monitoring (RPM) solutions, is pleased to announce that it has closed a non-brokered private placement (the "Private Placement") of 260 units (the "Units") of the Corporation at a price of $1,000 per Unit, for gross proceeds of $260,000 (the "Offering"). Each Unit is comprised of (i) a C$1,000 principal amount unsecured convertible debenture (each, a "Debenture") and (ii) 1,430 common share purchase warrants of the Corporation (each, a "Warrant"). The Debentures will mature on January 27, 2025 (the "Maturity Date") and shall bear interest at a simple rate of 10% per annum. The principal amount of the Debentures may be converted at the election of the holder thereof into common shares in the capital of the Company ("Common Shares") at a conversion price of C$0.35 per Common Share (the "Conversion Price") at any time prior to the Maturity Date. Each Warrant entitles the holder thereof to acquire one common share of the Corporation (each, a "Common Share") at a price of C$0.50 per Common Share at any time prior to 4:30 p.m. (Toronto Time) on January 27, 2024
As consideration for services rendered in connection with the Offering, the Corporation paid to certain registered brokers a cash commission in the amount equal to $13,000 (5% of the gross proceeds of the Offering); and (ii) issued to certain registered brokers 37,142 non-transferable common share purchase warrants (the "Broker Warrants"). Each Broker Warrant entitles the holder thereof to acquire one Common Share at an exercise price of $0.35 per Common Share for a period of 24 months from the date of closing of the Private Placement.
The Corporation intends to use the net proceeds from the Offering for sales, marketing, research and development and working capital requirements.
In accordance with applicable Canadian securities laws, all securities issued pursuant to the Offering will be subject to a four (4) month hold period ending July 19, 2022. The Offering remains subject to final approval from the TSX Venture Exchange.
The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. 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 the securities in any State in which such offer, solicitation or sale would be unlawful.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
Forward-Looking Information
This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Corporation to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. In particular, this news release includes certain forward-looking statements concerning the Offering, including the use of the net proceeds, as well as management's objectives, strategies, beliefs and intentions.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. In making the forward-looking statements in this news release, the Corporation has applied several material assumptions, including without limitation, information concerning the receipt of approval from the TSX Venture Exchange, the use of proceeds and the Corporation's marketing and research and development strategies and the expected benefits thereof.
Although management of the Corporation has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information.
The securities of the Corporation have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an available exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there by any sale of the securities referenced in this press release, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE:Cloud DX Inc.
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Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), an Australian leader in cell therapy, is pleased to announce that the first participant has been enrolled in the Phase 1/2 multi-centre clinical trial for CHM CDH17 cell therapy.
The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.
“This is great progress for this first-in-human study for bowel cancer patients with significant unmet need; congratulations to the CHM team and our investigational sites on this milestone.” said Dr Rebecca McQualter, Chief Operating Officer of Chimeric Therapeutics.
“It is exciting to see the advancement from the development of the CDH17 CAR T technology in our laboratory to the enrollment of the first patient in this Phase 1/2 study,” said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator.
Additional clinical trial sites are anticipated to open in the second half of 2024.
ABOUT CHIMERIC THERAPEUTICS
Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression.
To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.
Chimeric currently has a diversified portfolio that includes first in class autologous CAR T cell therapies and best in class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 3 current clinical programs and plans to open additional clinical programs in 2024.
Click here for the full ASX Release
This article includes content from Chimeric Therapeutics Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Tryptamine Therapeutics Limited (‘Tryp’ or the ‘Company’) (ASX: TYP), a clinical-stage biotechnology company focused on the development of an innovative and scalable intravenous-infused psilocin formulation which may be used in conjunction with psychotherapy to address significant unmet medical needs, is pleased to advise that it has successfully and safely completed the world’s first participant dosing using TRP-8803 (IV-infused psilocin) in a patient in Adelaide, South Australia.
Tryp advises that the participant was provided with TRP-8803, the Company’s innovative IV-infused psilocin solution on Friday, 28 June for approximately 140 minutes and progressed through the treatment safely. The participant was discharged after dosing follow-up was completed.
TRP-8803, Tryp’s lead program alleviates a number of significant shortcomings of oral psilocybin therapy. Potential advantages of the Company’s IV-infused psilocin solution include a significant reduction in the time to onset of the psychedelic state, more precise control of the depth and duration of the psychedelic experience and a reduction in the overall duration of the intervention to a commercially feasible timeframe.
The Company will continue to work alongside CMAX Clinical Research to deliver the solution to the additional participants over the coming weeks. Tryp anticipates to receive interim results from the trial during Q3 2024, which will provide a greater understanding of the solution’s potential in humans.
Management commentary:
Tryp Chief Executive Officer, Mr. Jason Carroll said: “We are very pleased to have completed the world’s first TRP- 8803 treatment in a patient in Adelaide. Pleasingly, the maiden participant was delivered the infusion safely and was discharged on treatment conclusion, which provides management with confidence of TRP-8803 and the completion of this Healthy Human Volunteer Study.
“The trial, which being undertaken alongside CMAX is an incredibly important initiative for Tryp, as it will provide us with data highlighting TRP-8803’s safety in humans at escalating doses. This will form the basis of the Company’s clinical trial pipeline into other indications and ultimately our regulatory engagement.
“The Company expects that up to 12 participants to undertake infusion over the coming weeks and we look forward to provide further updates as the trial advances.”
Click here for the full ASX Release
This article includes content from Tryptamine Therapeutics Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive interim results from its ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin (LP352) in participants ages 12-65 years old with Developmental and Epileptic Encephalopathies.
"We are thrilled to see a sustained, durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients. Additionally, we saw compelling seizure reduction in the PACIFIC placebo patients who transitioned to bexicaserin in the OLE. These data provide further support to bexicaserin's potential to offer a highly differentiated and best-in-class profile," stated Dr. Randall Kaye, Longboard's Chief Medical Officer.
"Given the tremendous unmet need in patients living with DEEs, we are committed to rapidly advancing the development of bexicaserin. We expect to provide additional analyses of these participants as they progress in the OLE Study and transition to our Expanded Access Program," Dr. Kaye continued. "With an End of Phase 2 meeting scheduled this summer, we remain on track to initiate our global Phase 3 program for bexicaserin later this year."
PACIFIC OLE Study Interim Analysis Results:
The PACIFIC OLE Study is a 52-week Phase 2, open-label, long-term safety study of bexicaserin in participants with a range of DEEs, including Dravet syndrome (n=3), Lennox-Gastaut syndrome (n=20) and DEE Other (n=18), who completed the PACIFIC Study (n=41). The study objectives are to investigate the safety and tolerability of multiple doses of bexicaserin in participants with DEEs, and to analyze the effect of bexicaserin on the frequency of observed countable motor seizures and other seizure types. The interim analysis was conducted when participants reached the approximate 6-month point in the OLE Study.
Summary of Efficacy Results:
The median change in countable motor seizure frequency for participants in the OLE Study over an approximate 6-month treatment period was a decrease of 56.1% (n=40) from their baseline entering the PACIFIC Study.
The median change in countable motor seizure frequency from baseline for:
Summary of Safety and Tolerability Results:
Favorable safety and tolerability results were observed in this study. 100% of PACIFIC Study completers elected to enroll in the OLE with 95.1% (39 out of 41) remaining in the ongoing open-label study. One participant discontinued due to the adverse event (AE) of lethargy and one participant discontinued by withdrawal of consent. The most common treatment emergent AEs in the overall group (n=41) occurring in >5% of patients were upper respiratory tract infections, COVID-19, pneumonia, sinusitis, seizures, and decreased appetite.
ABOUT THE PACIFIC STUDY AND THE OLE STUDY
The PACIFIC Study is a Phase 1b/2a double-blind, placebo-controlled clinical trial to assess the safety, tolerability, efficacy and pharmacokinetics of bexicaserin (LP352) in 52 participants between the ages of 12 and 65 years old with DEEs at 34 sites across the United States and Australia. Following a 5-week screening period and baseline evaluations, study participants initiated a dose titration over a 15-day period and subsequently continued on the highest tolerated dose throughout the maintenance period of 60 days. Following the maintenance period, participants were then titrated down, and eligible participants were given the opportunity to enroll in a 52-week open-label extension study.
ABOUT LONGBOARD PHARMACEUTICALS
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard's small molecule product candidates are based on more than 20 years of GPCR research. Longboard plans to advance bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, into a global Phase 3 program. Longboard recently reported positive topline data from a Phase 1b/2a clinical trial (the PACIFIC Study) evaluating bexicaserin in participants ages 12 to 65 years old with Developmental and Epileptic Encephalopathies (DEEs), including Lennox-Gastaut syndrome, Dravet syndrome and other DEEs. Longboard is also evaluating LP659, an oral, centrally acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions. Longboard is conducting a Phase 1 single-ascending dose (SAD) clinical trial for LP659 in healthy volunteers, with topline data expected in the second quarter of 2024.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. In some cases, you can identify forward-looking statements by words such as "focus", "potential", "expect", "committed to", "scheduled", "remain on track", "working to", "designed to", "plans", "will", or the negative, plural or other tenses of these words, references to future dates or time periods, or other comparable language, and they may include, without limitation, statements about the following: Longboard's clinical and preclinical product candidates and programs, including their potential (including for bexicaserin to be differentiated and to have a best-in-class profile), advancement, timing of initiating clinical trials (including a global Phase 3 program for bexicaserin), timing of topline data from clinical trials (including the Phase 1 SAD data for LP659), , the end of Phase 2 meeting, the ability of patients to progress in the OLE Study and transition to an expanded access program, and their design and characteristics; Longboard's ability to develop product candidates and deliver medicines; and Longboard's focus and work. For such statements, Longboard claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Longboard's expectations. Factors that could cause actual results to differ materially from those stated or implied by Longboard's forward-looking statements include, but are not limited to, the following: risk that topline or interim data may not accurately reflect the complete results of a particular study or trial, and that final data may differ materially from topline or interim data; PACIFIC Study participants' diagnoses are as of time of screening and are subject to change; risks related to Longboard's limited operating history, financial position and need for additional capital; Longboard's need for additional managerial and financial resources to advance all of its programs, and you and others may not agree with the manner Longboard allocates its resources; risks related to the development and commercialization of Longboard's product candidates; Longboard's product candidates are in the early to middle phases of a lengthy research and development process, the timing, manner and outcome of research, development and regulatory review is uncertain, and Longboard's product candidates may not advance in research or development or be approved for marketing; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; enrolling participants in Longboard's ongoing and intended clinical trials is competitive and challenging; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Longboard or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; macroeconomic events and their impact on Longboard's clinical trials and operations, the operations of Longboard's suppliers, partners, collaborators, and licensees, and capital markets; risks related to relying on licenses or collaborative arrangements; other risks related to Longboard's dependence on third parties; competition; product liability or other litigation or disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to regulatory compliance; and risks related to Longboard's and third parties' intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Longboard's forward-looking statements are disclosed in Longboard's filings with the Securities and Exchange Commission (SEC). These forward-looking statements represent Longboard's judgment as of the time of this release. Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240610482365/en/
CORPORATE CONTACT:
Megan E. Knight
VP, Head of Investor Relations
IR@longboardpharma.com
858.789.9283
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SZN-043 is a novel biotherapeutic shown to potentiate Wnt signaling and induce proliferation of hepatocytes in preclinical models
Treatment with SZN-043 in the Phase 1a trial was safe and well tolerated in healthy volunteers and patients with a history of liver cirrhosis
Phase 1a trial of SZN-043 demonstrated evidence of target engagement and Wnt-pathway mediated pharmacodynamic effects in the liver
Enrollment is ongoing in Phase 1b study in severe alcohol-associated hepatitis
Surrozen Inc. ("Surrozen" or the "Company") (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, presented a poster on the preliminary results of a Phase 1a study of SZN-043, a novel R-Spondin mimetic, in healthy volunteers and subjects with liver cirrhosis on June 8, 2024 at the 2024 European Association for the Study of the Liver (EASL) in Milan (LINK: HERE ).
Study Overview
Pharmacodynamic Biomarkers
The study provided evidence of Wnt-mediated pharmacodynamic activity in the liver after treatment with SZN-043.
"We were pleased to present the first clinical data from this innovative bispecific antibody-based approach to modulating the Wnt pathway. The Phase 1a study demonstrated activation of Wnt signaling, target engagement in the liver, the initial effects observed on liver function and that the drug was safe and well tolerated," said Craig Parker, President and Chief Executive Office of Surrozen. "We are making significant progress with our platform technologies as we focus on optimizing our abilities to modulate the Wnt pathway and provide important new therapeutic options through targeted cell and tissue regeneration. Wnt modulation in hepatocytes is a promising new mechanism for supporting regeneration in injured livers."
About SZN-043 for Severe Alcohol-Associated Hepatitis
SZN-043 is the first development candidate using Surrozen's SWEETS™ technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on severe alcohol-associated hepatitis. The Company has completed a Phase 1a clinical trial in patients with a history of liver cirrhosis and healthy volunteers. SZN-043 was safe and well tolerated in single or multiple IV doses and demonstrated evidence of target engagement, Wnt signal activation and effects on liver function.
The Phase 1b clinical trial in patients with severe alcohol-associated hepatitis began enrollment in the second quarter of 2024 and the Company expects that proof-of-concept data from this trial may be available in the first half of 2025. The study will enroll up to 30 patients with severe alcohol-associated hepatitis in an open-label trial. The study will evaluate safety, pharmacokinetics, immunogenicity and a number of efficacy endpoints including MELD score, Lille score and survival. The MELD and Lille scores have been shown to correlate with clinical improvement and 90-day survival.
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen's SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient's disease.
In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases. Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of $12.5 million. Surrozen will also be eligible to receive up to $587.0 million in success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. After an initial period of joint research, Boehringer Ingelheim will assume all development and commercial responsibilities.
About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, retina, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. Surrozen's platform and proprietary technologies have the potential to overcome the limitations in pursuing the Wnt pathway as a therapeutic strategy.
About Surrozen
Surrozen is a clinical stage biotechnology company discovering and developing drug candidates to selectively modulate the Wnt pathway. Surrozen is developing tissue-specific antibodies designed to engage the body's existing biological repair mechanisms with a current focus on severe liver and eye diseases. For more information, please visit www.surrozen.com .
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as "will," "plan," "intend," "potential," "expect," "could," or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen's discovery, research and development activities, in particular its development plans for its product candidates SZN-043 and SZN-413 (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease, as well as the potential benefits of such product candidates), and the Company's partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to SZN-043, SZN-413 and potential future drug candidates; the Company's ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen's ability to identify, develop and commercialize drug candidates; Surrozen's ability to successfully complete preclinical and clinical studies for SZN-043, SZN-413, or other future product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen's Annual Report on Form 10-K for the year ended December 31, 2023 and Surrozen's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 under the heading "Risk Factors," and other documents Surrozen has filed, or will file, with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen's expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen's assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor and Media Contact:
Investorinfo@surrozen.com
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Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced the pricing of its previously announced underwritten public offering of 13,001,120 shares of its common stock at a price to the public of $6.25 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 7,000,000 shares of common stock at a purchase price of $6.249 per share, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant.
The total gross proceeds to Annexon are expected to be $125.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Annexon. The offering is expected to close on June 7, 2024, subject to the satisfaction of customary closing conditions. In addition, Annexon has granted the underwriters a 30-day option to purchase up to an additional 3,000,168 shares of common stock.
J.P. Morgan, Jefferies, TD Cowen, BofA Securities and Wells Fargo Securities are acting as joint book-running managers for the offering.
The shares are being offered by Annexon pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 1, 2024. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. These documents can be accessed for free through the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 547-6340, or by email at Prospectus_Department@Jefferies.com; or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com; or BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, by telephone at 800-645-3751 (option #5), or by email at WFScustomerservice@wellsfargo.com.
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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon's novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "suggest," "target," "on track," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the expected gross proceeds from the offering and the closing date of the offering. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to, among other things, market conditions and the satisfaction of customary closing conditions related to the public offering. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the preliminary prospectus supplement and the accompanying prospectus, the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
Media Contact:
Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com
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MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (INKT) cell therapies to treat cancer and other immune-mediated diseases, today announced that its Annual Shareholders Meeting will begin at 9:30 a.m. ET. on June 12, 2024, and will be conducted in a virtual format only. Registration for attendees will start at 9:15 a.m. ET.
To participate in the Annual Shareholders Meeting, shareholders should visit www.virtualshareholdermeeting.com/INKT2024 and enter the 16-digit control number found in their proxy materials. Guests may also access the meeting in listen-only mode. No control number is required for guests.
Webcast Information:
Date: Wednesday, June 12, 2024
Time: 9:30 a.m. ET
A live webcast and replay will be accessible from the Company's website at https://investor.minktherapeutics.com/events-and-presentations and at www.virtualshareholdermeeting.com/INKT2024 .
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.
Investor Contact
917-362-1370
Media Contact
781-674-4428
communications@minktherapeutics.com
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