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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
- Cloud DX's Pulsewave vital signs monitor is worn on a patient's wrist, and oscillometric pulse waveforms are obtained as the cuff deflates, obtaining pulse wave signals and artifact signals over multiple patient breaths.
- Pulsewave software analyzes these signals producing an envelope of pulse waveforms as well as a frequency modulated sequence of pulses at various time intervals containing breathing rate data.
- Pulsewave 2.0 operates autonomously but can also be connected to the internet. When connected, clinicians receiving the data can derive additional biological metrics via the Cloud Diagnostics® online platform.
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
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Cloud DX partners with Sheridan College on Medical Metaverse Research and Development
- Funding awarded for mobile and machine learning healthcare innovation projects
- Supports commercialization of patented Cloud DX technology for the Medical Metaverse
- Research partnership between Sheridan's CMI and Cloud DX's eXtended Reality division, Cloud XR
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 Signs Contract with Paramedical Service Provider for Remote Patient Monitoring
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
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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 Signs Two Contracts with US Primary Care Clinics
Continued growth in US RPM as partner Maxwell Telecare signs two additional clinics in Illinois
News in Summary
- These RPM contracts bring the total Maxwell Telecare clinics in 2022 to five
- Addition of these two contracts brings this quarter's total number of contracts to twelve
- Reimbursed RPM programs have the potential to impact 33% of American adults1
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.
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Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
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 to provide Connected Heath™ kits and supporting software services
- Program will support up to 85 patients in palliative care
- This is the 10th contract this quarter for the Virtual Care platform
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
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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 Announces Closing of Private Placement
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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U.S. FDA Approves EMRELIS for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer With High c-Met Protein Overexpression
EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options Lung cancer remains the leading cause of cancer-related deaths throughout the worl d 1
NORTH CHICAGO, Ill. , May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EMRELIS ™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. 2,3
This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population. ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent 'payload' directly to the biomarker-expressing cell.
Approximately 85% of lung cancers are classified as NSCLC 4,5 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. 1 The c-Met protein is found to be overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients and is associated with poor prognosis. 2,6-12 Approximately half of these patients have high c-Met overexpression, defined as ≥ 50% of tumor cells with strong (3+) staining by immunohistochemistry (IHC) test. 2
"We have observed a paradigm shift in oncology in recent decades toward personalized, biomarker-driven therapeutics, allowing for better selection and optimized treatment outcomes," said Jonathan Goldman , MD, professor of medicine, director of thoracic oncology clinical trials, UCLA . "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and EMRELIS is a first-in-class ADC that can address a critical unmet need for this patient population."
"EMRELIS, AbbVie's first internally developed solid tumor medicine and our first solid tumor FDA approval in lung cancer, is a testament to our commitment to develop cancer therapies that aim to improve the course of treatment for patients facing this challenging disease," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie. "Leveraging advanced technology and data science, we are growing our ADC portfolio designed to deliver the right medicines to the right patients in need across a range of difficult-to-treat tumors."
"Despite the progress we have seen in the treatment of lung cancer, we need more options for people whose treatments stop working," said Upal Basu Roy , PhD, MPH, executive director of research, LUNGevity Foundation, a leading lung cancer nonprofit organization. "This approval is a welcomed targeted therapy for those with high c-Met protein overexpressing late-stage, non-small cell lung cancer who have seen very limited treatment innovation in the last decade."
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study ( NCT03539536 ), a study designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations. Findings from the study showed patients with high c-Met protein overexpression (n=84) who received EMRELIS demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12). The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. 2
In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.
EMRELIS is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01 . Enrollment in the study is underway and continues across global clinical trial sites. Additional information on clinical trials for EMRELIS is available at www.clinicaltrials.gov .
The FDA has also approved the Roche VENTANA ® MET (SP44) RxDx Assay, the only IHC companion diagnostic that identifies patients eligible for treatment with EMRELIS. To determine c-Met protein biomarker status, patients can be tested on recent or archived tissue.
About the LUMINOSITY Trial
The LUMINOSITY trial (NCT03539536) is an ongoing Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for telisotuzumab vedotin-tllv monotherapy in the second-line or third-line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS). 2
Patient Access and Support
AbbVie is committed to helping people access EMRELIS and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. Financial support might also include reimbursement for out-of-pocket costs related to IV administration. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides EMRELIS at no charge to those who qualify. More information can be found at www.AbbVie.com/PatientAccessSupport .
About EMRELIS
EMRELIS (telisotuzumab vedotin-tllv) is a first-in-class c-Met-directed antibody-drug conjugate (ADC) comprising of a c-Met-binding antibody, cleavable linker and the monomethyl auristatin E (MMAE) payload designed to target c-Met expressing cells. 3 The c-Met protein is a receptor tyrosine kinase that can be overexpressed in NSCLC and is associated with poor prognosis. 2, 6-12
EMRELIS (telisotuzumab vedotin-tllv) U.S. Uses and Important Safety Information 3
What is EMRELIS?
EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC):
- that has spread to areas near the lungs (locally advanced) or to other parts of the body (metastatic), and
- whose tumors have high c-Met protein overexpression, and
- who have received a prior treatment.
Your healthcare provider will perform a test to make sure EMRELIS is right for you.
It is not known if EMRELIS is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about EMRELIS?
EMRELIS can cause serious side effects, including:
- Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with EMRELIS and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including:
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- Lung problems. EMRELIS can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including:
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- Eye problems. Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including:
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- Infusion-related reactions. EMRELIS can cause infusion reactions that can be severe or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including:
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Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects.
Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of nerve problems
- have lung or breathing problems other than your lung cancer
- have eye problems
- have liver problems
- are pregnant or plan to become pregnant. EMRELIS can harm your unborn baby.
- Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS.
- You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS.
- Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS.
- Males with female partners who are able to become pregnant:
- You should use an effective birth control during treatment and for 4 months after taking the last dose of EMRELIS
- Females who are able to become pregnant:
- are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk. Do not breastfeed during treatment with EMRELIS and for 1 month after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with EMRELIS may increase your risk of side effects.
How will I receive EMRELIS?
- Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes.
- EMRELIS is given 1 time every 2 weeks.
- Your healthcare provider will decide how many infusions of EMRELIS you will receive.
What are the possible side effects of EMRELIS?
EMRELIS can cause serious side effects. See 'What is the most important information I should know about EMRELIS?"
The most common side effects of EMRELIS include:
- feeling tired
- decreased appetite
- swelling in the feet, ankles, legs, or hands
The most common severe abnormal laboratory tests results of EMRELIS include:
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EMRELIS may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of EMRELIS.
Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
Please see the Full Prescribing Information and Medication Guide .
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), Immuno-Oncology-based therapeutics, multi-specific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube.
AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Disclosure: Johnathan Goldman, MD has financial interests related to AbbVie.
References
- American Cancer Society. Key statistics for lung cancer. 2025. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed May 2, 2025 .
- Camidge DR, et al. Telisotuzumab Vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the Phase II LUMINOSITY trial. J Clin Oncol . 2024 Sep 1 ;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6 . PMID: 38843488; PMCID: PMC11361350.
- EMRELIS [package insert]. North Chicago, IL : AbbVie Inc: 2025.
- National Cancer Institute. Non-small cell lung cancer treatment – health professional version. https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc. Accessed May 2, 2025 .
- American Cancer Society. Cancer facts & figures 2025. American Cancer Society; 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf . Accessed May 2, 2025 .
- Bar, J. et al. 1397P Prevalence, molecular characterization, and prognosis of MET–overexpressing non-small cell lung cancer (NSCLC) in a real-world patient cohort. Ann Oncol , Volume 34, S799 - S800.
- Le X, Aggarwal C, Simmons A, et al. METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. Ann Oncol . 2024;35(S2):S829.
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians . 2024;74(3):229-63.
- Ansell PJ, Baijal S, Liede A, et al. Prevalence and characterization of c-Met–overexpressing non-small cell lung cancer (NSCLC) across clinical trial samples and real-world patient cohorts from the City of Hope National Medical Center. Cancer Research UK (CRUK) - Lung Cancer Conference; Manchester , UK2022.
- Liang H, Wang M. MET Oncogene in non-small cell lung cancer: Mechanism of MET dysregulation and agents targeting the HGF/c-Met Axis. Onco Targets Ther . 2020;13:2491-510.
- Park S, Choi YL, Sung CO, et al. High MET copy number and MET overexpression: poor outcome in non-small cell lung cancer patients. Histol Histopathol . 2012;27(2):197-207.
- Guo B, Cen H, Tan X, et al. Prognostic value of MET gene copy number and protein expression in patients with surgically resected non-small cell lung cancer: a meta-analysis of published literatures. PLoS One . 2014;9(6):e99399.
U.S. Media: Stephanie Tennessen +1 (224) 214-8638 | Investors: Liz Shea +1 (847) 935-2211 |
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SOURCE AbbVie
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AbbVie and ADARx Pharmaceuticals Announce Collaboration and License Option Agreement to Develop Next-Generation siRNA Therapies Across Multiple Therapeutic Areas
- Collaboration to leverage AbbVie's expertise in biotherapeutic drug development and commercialization together with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology
- AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, today announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology.
siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates the expression of genes. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.
The strategic collaboration will leverage ADARx's RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, antibody drug conjugates (ADCs) and tissue delivery approaches as appropriate, to augment ADARx's discovery efforts.
"siRNA is a promising genetic medicine approach for silencing disease-causing genes, but challenges still remain in targeting and delivering siRNA effectively," said Jonathon Sedgwick , Ph.D., senior vice president and global head, discovery research, AbbVie. "We are very pleased to collaborate with ADARx, leveraging their proprietary RNA technology alongside our antibody, ADC, and therapeutic area research and development expertise to bring siRNA forward as a potential novel therapeutic modality alongside our other established approaches. Together, we're committed to developing innovative solutions for difficult-to-treat diseases across neuroscience, immunology and oncology."
"This collaboration with AbbVie further validates the differentiated RNA technology that we have developed at ADARx and has the potential to unlock tremendous clinical and commercial potential across multiple disease areas. AbbVie's research and development expertise combined with its global commercial reach make them the ideal strategic collaborator to accelerate these programs for the potential benefit of patients worldwide," said Zhen Li , Ph.D., co-founder, president and chief executive officer of ADARx. "In addition to this strategic collaboration with AbbVie, ADARx continues to advance a deep pipeline of wholly-owned clinical-stage programs that span complement-mediated, cardiovascular and thrombotic diseases and various preclinical discovery programs including in obesity and neurodegeneration."
Under the terms of the agreement, ADARx will receive a $335 million upfront payment and will be eligible to receive several billion dollars in additional contingent payments including option-related fees and milestone payments, as well as tiered royalties.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) and YouTube.
About ADARx Pharmaceuticals
ADARx Pharmaceuticals, Inc. is a late clinical-stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. We are focused on advancing and expanding a deep pipeline of highly potent, durable and selective RNA-targeted therapeutic candidates, initially developing our product candidates for the treatment of complement-mediated, genetic, cardiovascular, central nervous system and metabolic (obesity) diseases. Follow ADARx on LinkedIn .
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
AbbVie Media Liz Tang, Ph.D. liz.tang@abbvie.com Investors Liz Shea liz.shea@abbvie.com | ADARx Media Teri Dahlman, Red House Communications teri@redhousecomms.com Investors Ajim Tamboli, CFA ir@adarx.com |
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SOURCE AbbVie
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Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
Two programs with clinical data readouts in 2H/2025
Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing with preliminary clinical data expected in 2H/2025; Trial now open for enrollment to patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE)
Preliminary data for ongoing ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) expected in 2H/2025
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2025.
"We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In the second half of 2025, we expect to report preliminary Phase 1 data from our two lead programs - ADI-001 in autoimmune diseases and ADI-270 in ccRCC, with more than 6 patients with at least 3-month follow up in both programs. As we progress toward these readouts, we also look to harness the full potential of our allogeneic gamma delta 1 CAR T cell therapy platform, which we believe has key advantages over other cell types. We have identified two promising highly differentiated programs, one targeting PSMA and one follow-on program targeting autoimmune diseases with potential to become best-in-class therapies for patients fighting autoimmune diseases and cancer."
First Quarter 2025 and Recent Operational Highlights:
Autoimmune diseases
- Enrollment open for LN and SLE patients in Phase 1 clinical trial of ADI-001 in autoimmune diseases. In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment.
- ADI-001 granted two new Fast Track Designations . In February 2025, the Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001 for the treatment of refractory SLE with extrarenal involvement and for SSc.
Hematologic malignancies and solid tumor indications
- Patient enrollment ongoing in Phase 1 trial of ADI-270 in metastatic/advanced ccRCC. Patient enrollment is underway in the Phase 1 clinical trial evaluating ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Adicet expects to share preliminary clinical data from the trial in 2H/2025.
- Oral presentation of ADI-270 data at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting. Adicet will present an oral abstract highlighting strong preclinical data demonstrating ADI-270's anti-tumor activity in hematologic and solid tumor models at the ASGCT Annual Meeting taking place May 13-17, 2025 in New Orleans, LA.
- Presented ADI-270 preclinical data at the Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting. In March 2025, Adicet presented posters covering preclinical data of ADI-270 at the SITC 2025 Spring Scientific Meeting.
Corporate Update
- Appointed Michael Grissinger to Board of Directors. In April 2025, Adicet appointed Michael Grissinger to its Board of Directors. Mr. Grissinger brings over four decades of leadership experience in biopharmaceutical business development, strategy, and M&A to Adicet. Mr. Grissinger has an extensive track record of driving commercial success for global pharmaceutical companies, with a strong focus on immunology. He also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc.
Financial Results for First Quarter 2025:
- Research and Development (R&D) Expenses: R&D expenses were $22.8 million for the three months ended March 31, 2025, compared to $23.9 million during the same period in 2024. The decrease in R&D expenses was primarily due to a net $1.4 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development.
- General and Administrative (G&A) Expenses: G&A expenses were $7.1 and 7.0 million for the three months ended March 31, 2025 and 2024, respectively.
- Net Loss: Net loss for the three months ended March 31, 2025 was $28.2 million, or a net loss of $0.31 per basic and diluted share, including non-cash stock-based compensation expense of $3.1 million, as compared to a net loss of $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million during the same period in 2024.
- Cash Position : Cash and cash equivalents were $150.4 million as of March 31, 2025, compared to $176.3 million as of December 31, 2024. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund its operating expenses into the second half of 2026.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com .
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet's product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; expectations regarding the presentation of preclinical data at future scientific conferences; and expectations regarding Adicet's uses of capital, expenses and financial results, including the expected cash runway.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet's business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Adicet's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
ADICET BIO, INC. Consolidated Statements of Operations and Comprehensive Income (in thousands, except share and per share amounts) (Unaudited) | ||||||||
Three Months Ended March 31, | ||||||||
2025 | 2024 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 22,814 | $ | 23,897 | ||||
General and administrative | 7,071 | 6,974 | ||||||
Total operating expenses | 29,885 | 30,871 | ||||||
Loss from operations | (29,885 | ) | (30,871 | ) | ||||
Interest income | 1,683 | 2,918 | ||||||
Interest expense | — | (2 | ) | |||||
Other expense, net | (12 | ) | (61 | ) | ||||
Loss before income tax provision | (28,214 | ) | (28,016 | ) | ||||
Income tax provision | — | — | ||||||
Net loss | $ | (28,214 | ) | $ | (28,016 | ) | ||
Net loss per share, basic and diluted | $ | (0.31 | ) | $ | (0.35 | ) | ||
Weighted-average common shares used in computing net loss per share, basic and diluted | 91,071,436 | 79,071,652 | ||||||
Other comprehensive income | ||||||||
Unrealized loss on treasury securities, net of tax | (25 | ) | — | |||||
Total other comprehensive income | (25 | ) | — | |||||
Comprehensive loss | $ | (28,239 | ) | $ | (28,016 | ) | ||
ADICET BIO, INC. Consolidated Balance Sheets Information (in thousands) (Unaudited) | |||||||||
March 31, | December 31, | ||||||||
2025 | 2024 | ||||||||
Cash, cash equivalents, and short term investments in treasury securities | $ | 150,439 | $ | 176,303 | |||||
Working capital | 137,116 | 160,744 | |||||||
Total assets | 191,271 | 220,219 | |||||||
Accumulated deficit | (526,108 | ) | (497,894 | ) | |||||
Total stockholders' equity | 161,446 | 186,609 | |||||||
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Adicet Bio, Inc.
Investor and Media Contacts
I nvestors:
Anne Bowdidge
abowdidge@adicetbio.com
Penelope Belnap
Precision AQ
212-362-1200
Penelope.belnap@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
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BOTOX® Cosmetic Continues its Mission of Empowering Entrepreneurs Through "The Confidence Project"
- BOTOX ® Cosmetic Will Provide 250 Entrepreneurs with Access to New Resources and Opportunities and Will Award 20 Grants Worth $20,000 Each to Support Business Goals.
- By 2030, BOTOX ® Cosmetic Pledges to Empower 50,000 Entrepreneurs, Helping to Close the Confidence Gap.
- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced BOTOX ® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs . The one & only BOTOX ® Cosmetic invites business owners to apply for this year's program starting today through May 9, 2025 at 11:59pm PT .
Women entrepreneurs continue to break barriers in the business world, with increasing efforts to close the Confidence Gap. When women founders are supported by mentors and have access to capital, they become agents of change. Seventy-one percent of businesswomen said their mentor was influential in their career advancement, with many using their income to uplift their families and community. 1
Since 2023, BOTOX ® Cosmetic has provided a total of $1 million dollars in grant funding across more than 40 founders, along with coaching and networking opportunities. This year, BOTOX ® Cosmetic is expanding to reach more founders by providing 250 entrepreneurs with access to The Confidence Project. Through a partnership with Hello Alice, an online platform that helps businesses launch and grow, each of the 250 entrepreneurs will participate in an intensive "Boostcamp" program, which will provide participants with skill-building, mentorship resources, and exclusive networking opportunities. After completing the course, they will leverage their newfound skills to pitch their business to a panel of aesthetic entrepreneurs, as well as key business leaders from Allergan Aesthetics and Hello Alice, for a chance to receive one of 20 $20,000 grants from BOTOX ® Cosmetic.
"BOTOX ® Cosmetic is committed to being a catalyst for confidence, whether that be by pursuing education, aesthetic treatment, or your entrepreneurial goals. Through The Confidence Project, we pledge to continue to uplift founders who've invested so much in their businesses," said Nicole Katz , Vice President, Customer Engagement and Corporate Affairs at Allergan Aesthetics. "We know when women have access to resources and capital, there's no limit to what they can achieve. We look forward to getting to know this year's cohort of founders and how they found the confidence to pursue their dreams."
"Our mission at Hello Alice is to help entrepreneurs access the funding, mentorship, and resources they need to succeed. BOTOX ® Cosmetic's The Confidence Project provides a powerful opportunity for women entrepreneurs to scale their businesses and create lasting change," said Elizabeth Gore , Co-Founder and President of Hello Alice. "Our partnership with BOTOX ® Cosmetic aims to foster long-term growth, confidence, and leadership for future generations of women in business, by investing in their success today."
Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact . Applicants must agree to the official rules of the grant program and submissions must be received by May 9, 2025 , at 11:59pm PT . The 250 women entrepreneurs selected to participate in the Hello Alice Boostcamp will be announced in July, and the 20 grant recipients will be announced in October 2025 .
For more information on The Confidence Project, visit www.botoxcosmetic.com/realimpact and follow @botoxcosmetic on Instagram and YouTube .
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn , Facebook , Instagram , X (formerly Twitter) , and YouTube .
Approved Uses
BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.
IMPORTANT SAFETY INFORMATION
BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.
BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX ® Cosmetic if you are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX ® Cosmetic.
Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.
Other side effects of BOTOX ® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.
For more information, refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.
Please see BOTOX ® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide .
References:
- Barbara Kurshan. Forbes.com. Purpose-Driven Women: Unleash Your Potential Through Mentorship. 2023 https://www.forbes.com/sites/barbarakurshan/2023/06/13/purpose-driven-women-unleash-your-potential-through-mentorship/
© 2025 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.
Contacts:
Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211
Media:
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525
View original content to download multimedia: https://www.prnewswire.com/news-releases/botox-cosmetic-onabotulinumtoxina-continues-its-mission-of-empowering-entrepreneurs-through-the-confidence-project-302444121.html
SOURCE AbbVie
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Adicet Bio to Participate in a Fireside Chat at the Citizens JMP Life Sciences Conference
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the 2025 Citizens JMP Life Sciences Conference being held from May 7-8, 2025 in New York.
Details of the event are as follows:
Date: Wednesday, May 7, 2025
Time: 1:30 p.m. ET
The live audio webcast can be accessed on the Investors section of Adicet Bio's website at http://www.adicetbio.com . An archived replay will be available for 30 days following the presentation.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20250430982018/en/
Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Penelope Belnap
Precision AQ
penelope.belnap@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
News Provided by Business Wire via QuoteMedia