Oxford Nanopore Announces Landmark UK Government Partnership to Advance Genomics-Driven Healthcare Innovation in the UK




Oxford Nanopore Announces Landmark UK Government Partnership to Advance Genomics-Driven Healthcare Innovation in the UK

• New strategic partnership between UK Biobank, Genomics England, NHS England and Oxford Nanopore designed to:
  • Advance biomedical research and translate discoveries for improved patient care
  • Improve health outcomes by targeting novel genomic and epigenomic discoveries in cancer, human genetic disease and infectious disease
• Initial programme: creation of an ‘early warning system’ for future pandemics across as many as 30 NHS sites to support improved biosecurity nationwide
• Oxford Nanopore’s high-performance genomics technology to provide richer genomic data, faster, more accessibly and more affordably

OXFORD, England–(BUSINESS WIRE)–Oxford Nanopore, the company delivering a new generation of nanopore-based molecular sensing technology, today announced a landmark strategic partnership with the UK Government. This partnership brings together the UK’s world-class scientific organisations Genomics England, UK Biobank and NHS England, alongside Oxford Nanopore, to support the government’s vision to build an NHS “fit for the future” by enabling genomics-based translational research and accelerating the development and adoption of Oxford Nanopore’s ground-breaking genomics technology in the NHS.

By utilising Oxford Nanopore’s richer genomic insights, rapid, scalable and affordable sequencing technology, the initiative aims to deliver transformative improvements in patient care and foster economic growth in the UK’s thriving life sciences sector.

Oxford Nanopore CEO Gordon Sanghera, commented:

“The UK has a remarkable genomics ecosystem, and we are delighted to be innovating more collaboratively through this partnership. Genomics England and UK Biobank have led the way in scaling genomics discovery and translating these advances into patient impact. NHS England, through its Networks of Excellence and advancements developed by the Genomic Laboratory Hubs (GLHs), has been instrumental in adopting these innovations into national healthcare strategies. By working alongside our partners on shared goals of improved patient outcomes – whether in cancer, human genetic disease or infectious disease – we believe we can deploy our unique DNA/RNA sequencing technology in ways that are most impactful for the people of the UK.”

Health and Social Care Secretary Wes Streeting, commented:

“If we fail to prepare, we should prepare to fail. Our NHS was already on its knees when the pandemic struck, and it was hit harder than any other comparable healthcare system.

“We cannot let history repeat itself. That’s why this historic partnership with Oxford Nanopore will ensure our world-leading scientists have the latest information on emerging threats at their fingertips.

“As we embrace the technological revolution, our 10 Year Health Plan will shift the NHS away from analogue to digital, saving countless more lives.”

Science and Technology Secretary Peter Kyle, commented:

“During the Covid pandemic we saw the power of the UK life sciences sector very clearly – from the Oxford-Astra Zeneca vaccine that saved so many lives, through to operating one of the world’s most effective Covid surveillance systems, which spotted several emerging variants of the disease.

“This partnership will build on that expertise to monitor emerging diseases as they arise, putting our scientists and decision-makers one-step ahead and providing the information they need to make informed decisions.

“Together with the ability to better diagnose cancers and rare diseases, we are leveraging UK life sciences to protect the public and ultimately save lives.”

Professor Susan Hopkins, Chief Medical Advisor at UK Health Security Agency, commented:

“Early detection is absolutely crucial in enabling us to respond effectively to any emerging pathogen. The UK already has a wealth of expertise in genomic surveillance, and this programme will build on that expertise and enable us to bring our resources and capability to tackle developing threats at greater speed. Enhancing the capacity for the NHS to determine new and emerging pathogens causing severe acute respiratory infections will improve the detection and emergence of infections.

“As part of the 100 days mission, this will enable the development of effective diagnostics for novel pathogens and enhance our pandemic preparedness.”

Professor Ian Abbs, Chief Executive of Guy’s and St Thomas’ NHS Foundation Trust, commented:

“We’ve been working on the respiratory metagenomics programme for over four years and have clearly seen the benefit to our patients. It’s a momentous day now that we can ensure other hospitals, and more patients, can also benefit from faster and more accurate treatment for severe respiratory conditions thanks to new genomic technology.”

Advancing the understanding of genomics, for future disease prevention and personalised medicine

Oxford Nanopore’s partnership with Genomics England and UK Biobank is aimed at translating research-based discoveries from the lab into clinical settings, benefiting UK healthcare. Priority areas include cancer, where genomic insights (the analysis of DNA) can help identify personalised treatment options and enhance early detection, and rare disease characterisation, where information-rich genomic and epigenetic analysis – changes to DNA that contribute to disease – can improve diagnosis and inform targeted therapies. This partnership presents a further opportunity to collaborate on broader emerging applications, which in the future could include newborn screening, where genomics can enable early identification of genetic disorders for prompt intervention, and pharmacogenomics, where genetic insights guide safer and more effective medication choices tailored to an individual’s genetic profile.

Creating a world-first pathogen surveillance system in the NHS

As a key part of the partnership, the UK will establish the first real-time, pathogen-agnostic biosurveillance system across as many as 30 hospitals in NHS England—a crucial early warning framework to detect and respond to emerging pandemics and biological threats. Building on successful NHS England Network of Excellence pilots led by Guy’s and St Thomas’ NHS Foundation Trust (GSTT), this system will expand the NHS Respiratory Metagenomics programme to enable rapid pathogen identification across the UK. This data will be provided by the NHS to the UK Health and Security Agency, allowing potentially quicker decisions on emerging diseases to be taken and bolstering national biosecurity as set forth in the UK Biological Security Strategy. This project is expected to start in 2025 and will continue over multiple years.

In addition to providing biosecurity capabilities, the expanded respiratory metagenomics programme will deploy Oxford Nanopore’s sequencing technology to support infectious disease management in the critical care setting. This rollout is designed to provide a groundbreaking, six-hour timeline for fully characterising respiratory diseases including drug (antimicrobial) resistance, an essential leap forward in patient care. By rapidly transitioning NHS diagnostics from analogue to digital, the programme’s goal is to enable quicker, targeted care for patients and reduce hospital strain, advancing the ambitions set out in the Government’s 10-Year Health Plan.

Translating genomics into enhanced NHS patient care

The integration of Oxford Nanopore’s innovative sequencing technology will enable the NHS to explore further this technology to characterise diseases including cancer and rare genetic conditions with greater speed and precision. With potential for collaborative development of rapid and improved diagnostic tools, Oxford Nanopore’s technology has the potential to enable patients across the NHS to benefit from earlier, more accurate disease detection and treatment pathways.

Driving economic growth and workforce development in life sciences

This work will not only enhance patient outcomes but also position the UK as a global leader in genomic research and innovation, further strengthening the nation’s biosecurity and healthcare resilience. By accelerating pathways for life sciences innovation into the NHS through globally recognised research programmes, this collaboration enhances the UK’s position as a global biotechnology hub, supporting economic growth and creating high-value jobs in the life sciences ecosystem. As part of this initiative, NHS staff and researchers will gain access to relevant training and support to advance a skilled workforce ready to harness the potential of genomics and personalised medicine.

About Oxford Nanopore Technologies

Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 125 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes.

For more, visit: https://nanoporetech.com/
For images, visit: https://nanoporetech.com/about/for-the-media

Forward-looking statements

This announcement contains certain forward-looking statements. For example, statements regarding expected revenue growth and profit margins are forward-looking statements. Phrases such as “aim”, “plan”, “expect”, “intend”, “anticipate”, “believe”, “estimate”, “target”, and similar expressions of a future or forward-looking nature should also be considered forward-looking statements. Forward-looking statements address our expected future business and financial performance and financial condition, and by definition address matters that are, to different degrees, uncertain. Our results could be affected by macroeconomic conditions, delays or challenges in manufacturing or delivering of products to our customers, suspensions of large projects and/or acceleration of large products or accelerated adoption of pathogen surveillance or applied uses of our products. These or other uncertainties may cause our actual future results to be materially different than those expressed in our forward-looking statements.

Contacts

media@nanoporetech.com

LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision




LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision

SEATTLE–(BUSINESS WIRE)–#DryAMD–LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the U.S. Food & Drug Administration (FDA) has authorized marketing of Valeda^® Light Delivery System for treatment of patients with dry age-related macular degeneration (AMD), a leading cause of central vision loss in people over 55 in developed countries.

The Valeda therapy is the first ever authorized treatment by the FDA for vision loss in dry AMD patients. Valeda provides an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent to a line on the eye chart. In the pivotal U.S. LIGHTSITE III trial, the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity.

LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a De Novo request with special controls.

“The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System,” stated Lori Holder, Vice President, Regulatory Affairs, LumiThera, Inc.

“The RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile,” stated David Boyer, MD, Retina Vitreous Associates Medical Group, Beverly Hills, CA. “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process. This is an exciting option for patients and something doctors and patients have been waiting for.”

“The primary endpoint for the study was visual acuity gain,” indicated Glenn Jaffe, MD, Duke Reading Center. However, we also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether PBM helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers. For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease.

“We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our U.S. patients for several years. We now have a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss,” stated Clark Tedford, Ph.D., President and CEO. “The FDA authorization of the Valeda treatment to improve vision in dry AMD now provides a significant option for our US patients.”

About AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About LumiThera

LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light^™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, particularly dry AMD.

LumiThera is the leader in ophthalmic photobiomodulation (PBM) innovation with its flagship product, the Valeda^® Light Delivery System. Multiwavelength Valeda treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of Valeda Treatment for dry AMD Patients to Improve Vision. Valeda is CE Marked in the EU and is available in select countries in Latin America.

AdaptDx Pro^® is a portable dark adaptometer that utilizes AI to deliver a uniform patient experience. Impaired dark adaptation is the earliest biomarker of dry AMD and can be detected three years before clinical presentation. AdaptDx Pro is available in the U.S. and Canada.

NOVA Vision Testing System is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. VEP is available in the U.S. and select countries outside of the U.S. ERG is only available outside of the U.S.

For more information on Valeda, visit www.lumithera.com. AdaptDx Pro and NOVA are available through LumiThera Diagnostics, Inc. and Diopsys, Inc., respectively.

Contacts

Allison Dabney

adabney@lumithera.com
Senior Director, Marketing

GeneDx to Highlight Key Research Findings at American Society of Human Genetics (ASHG) Annual Meeting




GeneDx to Highlight Key Research Findings at American Society of Human Genetics (ASHG) Annual Meeting

Data to be presented showcasing GeneDx’s ongoing commitment to spearheading industry-leading research to drive transformational clinical utility

STAMFORD, Conn.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced its scientific contributions at the 2024 American Society of Human Genetics (ASHG) annual meeting. GeneDx data will be presented across six platform presentations and five posters and will unveil findings from key research initiatives constructed on the backbones of its industry leading diverse dataset of more than 700,000 clinical exome and genomes.

GeneDx leverages its database as a critical tool in a number of studies to drive transformational clinical care for pediatric patients as the industry continues to look for strong evidence to expand the utilization and clinical utility of genome sequencing. Through these strategic collaborations with SeqFirst, The University of Washington, PacBio the Autism Sequencing Consortium and GUARDIAN, GeneDx showcases the accessibility, affordability and actionability of exome and whole genome sequencing (WGS) in pediatric patients.

Research to be presented this week at ASHG will include:

Rapid whole genome sequencing (rWGS) in the NICU leads to changes in clinical care:

• In collaboration with SeqFirst, patient cases were analyzed when a diagnosis was found with rWGS to understand how decisions were made with genomic sequencing and what is missed in its absence when only using conventional care protocols.

Racial disparities in an accurate genetic diagnosis:

• In one of the largest studies to look at ancestral backgrounds and genetic diagnosis, GeneDx, the University of Washington, and Geisinger explore the value of a diverse dataset to understand diagnostic yield and if it varies significantly based on ancestral background or if other factors are limiting access to a genetic diagnosis.

Data validation for long read sequencing:

• With growing interest in the field to explore the clinical utility of long read sequencing, validation data will be presented assessing the sensitivity of PacBio’s HiFi long read sequencing to detect cases with a confirmed answer on short read whole genome sequencing (WGS) Additional cases where long read sequencing uncovered pathogenic variants that were difficult to detect on short read WGS will be presented.

Genetic variants linked to Autism Spectrum Disorder (ASD):

• Working alongside the Autism Sequencing Consortium, research identifies 230 new genes associated with ASD. This molecular evidence underscores the effectiveness and accuracy of genetic diagnostics compared to current methods, which rely on parents’ or caregivers’ accounts of their child’s development or professional observations of behavior.

“The opportunity to present these findings at ASHG underscores GeneDx’s commitment to advancing genomic research to move forward its application in clinical settings,” said Dr. Paul Kruszka, MD, FACMG, Chief Medical Officer at GeneDx. “Our collaborations with leading research initiatives allow us to leverage our industry-leading dataset to drive innovation and improve patient outcomes. Across the board this work not only highlights the proven clinical utility of genomic testing but emphasizes the importance of equitable access.”

GeneDx collaborated on the following:

Presentations:

• Wednesday, November 6, 9:15 am MT: Unveiling the crucial neuronal role of the proteasomal ATPase subunit gene PSMC5 in neurodevelopmental proteasomopathies. Janelle Stanton, PhD (University of Limerick, Ireland) – Room 505 Session 12
• Thursday, November 7 at 1:30 pm MT: Use of exclusion criteria to select critically ill newborns for rapid genome sequencing captures precise genetic diagnoses missed by use of conventional inclusion criteria. Tara Wenger, MD, PhD (University of Washington) – Room 505 Session 54
• Friday, November 8 at 10:45 am MT: Genome-wide profiling of highly similar paralogous genes using HiFi sequencing. Xiao Chen, PhD (PacBio) – Four Seasons Ballroom 4 Session 71
• Friday, November 8 at 11:15 am MT: Benchmarking detection of technically challenging pathogenic variants with long-read sequencing and a head-to-head comparison with short-read sequencing in a clinical diagnostic laboratory. Joseph M. Devaney, PhD (GeneDx) – Four Seasons Ballroom 4 Session 71
• Friday, November 8 at 1:45 pm MT: The largest to-date exome study of autism spectrum disorder triples the number of autism-associated genes. Frederick Satterstrom, PhD (Broad Institute) – Room 401 Session 78
• Friday, November 8 at 6:00 pm MT: Expanded newborn screening using genome sequencing for early actionable conditions: results of the first 10,000 participants enrolled in the GUARDIAN study. Wendy Chung, MD, PhD (Boston Children’s Hospital) – Mile High Ballroom Session 86

Posters:

• Thursday, November 7 at 2:30 pm MT: Racial disparities in access to a precise genetic diagnosis are not due to differences in diagnostic yields. Jessica X. Chong, PhD (University of Washington)
• Thursday, November 7 at 2:30 pm MT: Partial methylation of a pathogenic XYLT1 repeat expansion associated with intrafamilial variation in severity of Desbuquois dysplasia 2. Michael J. Bamshad, MD (University of Washington)
• Friday, November 8 at 2:30 pm MT: Genetic etiologies and diagnostic yield of exome sequencing in pediatric motor speech disorders. Marissa Mitchel, MS (Geisinger Autism & Developmental Medicine Institute)
• Friday, November 8 at 2:30 pm MT: Evaluating dosage sensitivity predictions for multigenic copy number variants to facilitate clinical interpretation. Erin Riggs, MS (Geisinger)
• Friday, November 8 at 2:30 pm MT: De novo variants in GTF2H1 underlie variable syndromic developmental delay. Karynne Patterson, BS/BA (University of Washington)

About GeneDx:

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com and connect with us on LinkedIn, Facebook, and Instagram.

Contacts

Press@genedx.com

Investors@genedx.com

Mirum Pharmaceuticals to Announce Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024




Mirum Pharmaceuticals to Announce Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will report third quarter 2024 financial results on November 12, 2024. Mirum will also host a conference call to discuss the third quarter 2024 financial results and recent corporate progress.

Conference call details:

Tuesday, November 12, 2024

8:30 a.m. ET / 5:30 a.m. PT

Dial-in:

U.S./Toll-Free: + 1 833 470 1428

International: + 1 404 975 4839

Passcode: 749358

You may also access the call via webcast by visiting the Events & Presentations section on Mirum’s website. A replay of this webcast will be available for 30 days.

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat) oral solution, CHOLBAM® (cholic acid) capsules, and CHENODAL® (chenodiol) tablets.

LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms or liver disease. CHENODAL has received medical necessity recognition by the FDA to treat patients with cerebrotendinous xanthomatosis (CTX).

Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis. Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Lastly, chenodiol, has been evaluated in a Phase 3 clinical study, RESTORE, to treat patients with CTX, with positive topline results reported in 2023. Mirum has submitted a new drug application with the FDA for the approval of chenodiol to treat CTX in the U.S.

To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and Twitter (X).

Contacts

Investors:

Andrew McKibben

ir@mirumpharma.com

Media:

Erin Murphy

media@mirumpharma.com

Sangamo Therapeutics Announces Third Quarter 2024 Conference Call and Webcast




Sangamo Therapeutics Announces Third Quarter 2024 Conference Call and Webcast

RICHMOND, Calif.–(BUSINESS WIRE)–Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, announced today that the company has scheduled the release of its third quarter 2024 financial results after the market close on Tuesday, November 12, 2024.

The company will hold a conference call at 4:30 p.m. Eastern on Tuesday, November 12, which will remain open to the public. During the conference call, the company will review its financial results and provide business updates.

Participants should register for, and access, the call using this link. While not required, it is recommended to join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided, or to use the dial-out option to connect their phone instantly. The link to access the live webcast can also be found on the Sangamo Therapeutics website in the Investors and Media section under Events.

A replay will be available following the conference call, accessible under Events.

About Sangamo Therapeutics

Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including in the central nervous system. Sangamo’s pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit www.sangamo.com and connect with us on LinkedIn and X.

Contacts

Investor Relations & Media Inquiries
Louise Wilkie

ir@sangamo.com
media@sangamo.com

Nuclera’s eProtein Discovery System Installed at Domainex to Streamline Protein Production Services




Nuclera’s eProtein Discovery System Installed at Domainex to Streamline Protein Production Services

• Domainex is the first CRO to have installed the eProtein Discovery system
• Installation of Nuclera’s technology expands Domainex’s protein production services

CAMBRIDGE, England–(BUSINESS WIRE)–Nuclera, the biotechnology company accelerating protein expression and optimization through its benchtop eProtein Discovery™ system, and Domainex, a multi-award winning provider of integrated, pre-clinical drug discovery services, today announced that Domainex is the first contract research organization (CRO) to have installed the eProtein Discovery system and offer protein production services using the technology.

Domainex provides a complete range of pre-clinical drug discovery services from protein production to medicinal chemistry for lead optimization. Installing eProtein Discovery expands Domainex’s service offering and enhances the company’s protein production workflows. Working with Domainex, more researchers will benefit from eProtein Discovery, supporting Nuclera’s mission to better human health by enabling scientists to easily access the proteins they need for their drug discovery research. For companies that are not yet ready or able to invest in the instrument, this provides another route to access the technology.

Nuclera’s eProtein Discovery system is designed to speed up protein expression and purification optimization in research labs, particularly those using AI including ML for protein design. Applying digital microfluidics alongside in situ protein detection assays and cell-free protein synthesis, eProtein Discovery enables rapid, scalable access to high-quality proteins, supporting both cell-free and cell-based expression methods. The system significantly reduces time and cost of these processes by automating construct screening, protein scale-up, and producing purified proteins for downstream functional testing in under 48 hours. The system accelerates workflows, achieving results in days rather than the months required by traditional cell-based methods.

Joseph Bertelsen, Chief Commercial Officer, Nuclera, commented: “We are excited to have trusted protein experts like Domainex as our first CRO Partner assisting us in making eProtein Discovery accessible to scientists worldwide. The eProtein Discovery™ system is poised to transform the landscape of protein research, making it an essential tool for anyone involved in the science of proteins. This installation reaffirms Nuclera’s commitment to accelerating discovery through easy and fast protein production, ensuring every protein project begins on eProtein Discovery™.”

Natalie Winfield, Executive Vice President, Commercial Operations, Domainex, added: “We are delighted to be the first CRO to offer a protein production service via the eProtein Discovery™ system. At Domainex, we are constantly evolving our service offering, ensuring that we have the latest and most innovative technologies, so we can apply optimal approaches to our clients’ drug discovery programs.”

For more information about Nuclera’s eProtein Discovery system, please visit: https://www.nuclera.com/system/

To learn more about our partnership with Domainex, please visit: https://www.nuclera.com/company/partners/

Contacts

Media:
Dr Ben Rutter

Zyme Communications

Tel: +44(0)7920 770 935

Email: ben.rutter@zymecommunications.com

Celebrating 25 Years of Sculptra®: New Data and Recent Approval in China Cements Galderma’s Leadership in Regenerative Biostimulation




Celebrating 25 Years of Sculptra®: New Data and Recent Approval in China Cements Galderma’s Leadership in Regenerative Biostimulation

• Galderma celebrates the 25^th anniversary of the approval of Sculptra^®, the first proven regenerative biostimulator, with new data, another approval, and expanding treatment applications^1-5
• New data presented at this year’s American Society for Dermatologic Surgery Annual Meeting and published in the prestigious Journal of Drugs in Dermatology showcase Sculptra’s unique regenerative properties^5-8
• Sculptra was also recently approved in China, one of the fastest growing aesthetics markets, further expanding its global reach and accessibility to patients⁹
• Galderma remains committed to collaborating with the aesthetics community and exploring the possibilities of Sculptra in regenerative aesthetics to continue to meet evolving needs, such as the emerging need to address facial alterations associated with rapid weight loss

ZUG, Switzerland–(BUSINESS WIRE)–This month marks the 25^th anniversary of the approval of Sculptra^®, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation.^1-5,10-16 Sculptra works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance, and has been a cornerstone of Galderma’s broad portfolio of proven aesthetic treatments.^17,18 During its 25 years on the market, healthcare professionals have treated millions of patients with Sculptra, with distribution in over 40 countries and regions worldwide.^10,12,19,20

Pioneer in regenerative aesthetics: Working with the natural processes of the skin

Regenerative aesthetics is an emerging and fast-growing trend in the field.^21,22 It focuses on revitalizing the skin by engaging the body’s own healing mechanisms, working across three layers of the skin to restore and rejuvenate from within and address patient concerns such as volume loss, skin laxity, and structural support loss.^{1,13,18,23-26}

Recent gene expression data from a head-to-head study presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting showed that Sculptra stimulated more components of the extracellular matrix, including collagen and elastin, while inducing less inflammation, when compared with another biostimulator.⁶ Sculptra stimulated 16 pathways related to tissue remodeling and four related to collagen formation, compared to 10 and three, respectively, for the comparator biostimulator.⁶

Additional data presented at the ASDS 2024 Annual Meeting demonstrate Sculptra’s potential positive effect on adipocyte modulation, which might explain its clinical benefits in skin quality such as increased skin glow, improved facial fat function and structure, and reduced signs of facial aging.⁷ The data showed that treatment with Sculptra resulted in upregulation of 13 genes associated with anti-inflammatory effects and adipocyte modulation.⁷

This was reinforced by two new studies published this year in the Journal of Drugs in Dermatology, which provided supportive as well as deeper insights into the regenerative effects of Sculptra.^5,8 This includes results showing that Sculptra significantly reduced the severity of moderate or severe cheek wrinkles while improving skin quality, with results lasting across the 12-month study period.⁸ The responder rate was significantly higher for Sculptra versus the no-treatment control at seven months (66.2% and 38.6%), nine months (70.6% and 31.1%) and 12 months (71.6% and 26.1%).⁸ Sculptra maintained high patient satisfaction, with over 84% of patients reporting natural-looking results and expressing interest in repeat treatments to correct cheek wrinkles.⁸

Sculptra’s PLLA-SCA™ formulation ensures comprehensive results that improve the skin’s underlying structure, as well as surface appearance.^1,13,23-25 By remodeling components of the extracellular matrix, such as elastin and collagen, Sculptra can restore youthful volume through its regenerative properties.^2,6,7,27-28

Celebrating 25 years of scientific progress with Sculptra

Sculptra was first launched and approved in the European Union as a volume replenishment treatment in 1999 to correct the facial wasting experienced by AIDS patients.²⁸ A transformative treatment, Sculptra helped reverse the gaunt appearance associated with this disease by stimulating the skin’s natural collagen and elastin production, restoring facial vitality and youthful volume.^6,7,28,29

Over the years, through Galderma’s continued research into Sculptra’s unique scientific dermatological potential with PLLA-SCA™, it has evolved into a versatile treatment with a range of applications beyond volumization, which can include skin firmness, structural support, radiance, and overall skin quality, with results lasting for over two years.^2,17,29,30

Recent research shows that, in addition to collagen, Sculptra’s PLLA-SCA™ formulation also has a stimulatory effect on key components of the extracellular matrix, such as elastin, proteoglycans and multi-adhesive glycoproteins, and agents which activate the remodeling of adipose (fat) tissue, making it the first proven regenerative biostimulator.^1-7,24,28 These properties open exciting new possibilities to meet emerging patient needs, such as addressing facial alterations associated with significant or rapid weight loss.²⁹

Sculptra is approved by multiple regulatory authorities, most recently in China – one of the fastest-growing markets in aesthetics and a key growth driver for Galderma.^9,31,32 This approval further expands Sculptra’s global reach and accessibility and underscores its ability to meet diverse patient needs and beauty standards across different regions.

About Sculptra^®

Sculptra is the first proven regenerative biostimulator, with a unique PLLA-SCA™ formulation that helps restore the deep, underlying structure of the skin.^{1-5,10-16,23-25} Sculptra works to address the underlying causes of facial aging, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.^1,13,23-25 Sculptra encourages the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore facial volume and the look of fullness to wrinkles and folds over time.^6,7,27,28 The results from Sculptra are long-lasting, with optimal correction seen in approximately three months and results lasting up to two years.^2,17,24,33

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Sculptra^®. EU Instructions for Use. 2021. Available online. Accessed October 2024
2. Widgerow A, et al. A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress, February 1-3, 2024, Paris, France
3. Galderma. Data on File (MA-60875)
4. Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042
5. Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression. J Drugs Dermatol. 2024;23(4):285-288. doi: 10.36849/JDD.7791
6. Waibel J, et al. Gene Analysis of Biostimulators: PLLA-SCA Triggers Regenerative Morphogenesis while CaHA-R Induces Inflammation upon Facial Injection. Poster presented at ASDS 2024, October 17-20, 2024, Orlando, Florida, United States
7. Waibel J, et al. Bulk RNA-seq Analysis of Poly-L-Lactic Acid (PLLA-SCA) vs Calcium Hydroxyapetite (CaHA-R) Reveals a Novel, Adipocyte Mediated Regenerative Mechanism of Action Unique to PLLA. Poster presented at ASDS 2024 Annual Meeting, October 17-20, 2024, Orlando, Floria, United States
8. Fabi S, et al. Effectiveness and Safety of Sculptra PLLA Inj. Implant in the correction of Cheek Wrinkles. J Drugs Dermatol. 2024;23(1):1297-1305. doi: 10.36849/JDD.7729
9. Galderma. Galderma Q3 earnings media release. Available online. Accessed October 2024
10. U.S. Food and Drug Administration. Summary of safety and effectiveness data. Available online. Accessed October 2024
11. Galderma. Data on File (MA-46589)
12. Duracinsky M, et al. Safety of poly-L-lactic acid (New-Fill^®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients. BMC Infect Dis 2014;14(474). doi:10.1186/1471233414474
13. Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018;27(5):729-738. doi: 10.1177/0963689717725755
14. Asius J, et al. Inventors. US patent US 7,731,758 B2.2010. Available online. Accessed October 2024
15. Morgan P, et al. Product Manufacturing Process for Poly-L-lactic acid (PLLA-SCA). Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France
16. Galderma. Data on File (MA-53568)
17. Hexsel D, et al. Introducing the L-Lift-A Novel Approach to Treat Age-Related Facial Skin Ptosis Using A Collagen Stimulator. Dermatol Surg. 2020;46(8):1122–1124. doi:10.1097/DSS.0000000000002015
18. Fabi S, et al. A multi-center, retrospective, chart review to evaluate the safety of poly-L-lactic acid injectable implant when used in non-facial areas. Poster presented at IMCAS World Congress, January 26–28, 2023, Paris, France
19. Galderma. Galderma Continues Global Growth Ambition With Sculptra^® (injectable poly-L-lactic acid) Re-launch in Europe. Available online. Accessed October 2024
20. Galderma. Data on File (MA-54105)
21. Trovato F, et al. Advancements in Regenerative Medicine for Aesthetic Dermatology: A Comprehensive Review and Future Trends. Cosmetics. 2024;11(2):49. doi:10.3390/cosmetics11020049
22. Hamilton Fraser. Emerging aesthetic trends and technologies in 2024. Available online. Accessed October 2024
23. Shuster S, et al. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93(6):639-43. doi: 10.1111/j.1365-2133.1975.tb05113.x
24. Goldberg D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39:915–22
25. Zarbafian M, et al. The emerging field of regenerative aesthetics—where we are now. Dermatol Surg. 2022;48: 101–108. doi: 10.1097/DSS.0000000000003239
26. Galderma. Data on file
27. Haddad S, et al. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022;61:1284–1288. doi: 10.1111/ijd.16229
28. Vleggaar D, et al. Consensus recommendations on the use of injectable poly-L-lactic-acid for facial and nonfacial volumization. J Drugs Dermatol 2014;13(4 Suppl):s44–s51
29. Avelar LE and Haddad A. Facial assessment for poly-l-lactic acid application—One product, different outcomes. J of Derm & Cos. 2023;7,3. doi: 10.15406/jdc.2023.07.00239
30. Snyder A, et al. Sculptra^®—History and how it is best used today. Derm Reviews. 2023;4(3). doi: 10.1002/der2.186
31. Kwon SH, et al. Experiences and attitudes toward aesthetic procedures in East Asia: a cross-sectional survey of five geographical regions. Arch Plast Surg. 2021;48(6):660-669. doi: 10.5999/aps.2020.02565
32. Asia Pacific Medical Aesthetics Market Size, Share & Industry Trends Analysis Report By End User (Clinics, Hospitals, & Medicals Spas, Beauty Centres, & Home Care Settings), By Procedure, By Product, By Country and Growth Forecast, 2023 – 2030. Available online. Last accessed October 2024
33. Fabi S, et al. 24-month clinical trial data on effectiveness and safety after correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant. Poster presented at AMWC, March 30 – April 1, 2023, Monaco

Contacts

For further information:


Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

CinFina Pharma Presents Positive Phase 1 Study Results in Poster Session for CIN-109 and in Late-Breaking Poster for CIN-110, Demonstrating the Potential of Next-Generation Mechanisms at ObesityWeek® 2024




CinFina Pharma Presents Positive Phase 1 Study Results in Poster Session for CIN-109 and in Late-Breaking Poster for CIN-110, Demonstrating the Potential of Next-Generation Mechanisms at ObesityWeek® 2024

CIN-110 was well-tolerated and demonstrated noteworthy decreases in caloric intake and weight compared to placebo based on topline interim data from Phase 1 single ascending dose (SAD) study

CIN-109 produced meaningful weight loss and was generally well-tolerated across all dose levels in Phase 1 multiple ascending dose (MAD) study, including at the highest dose tested, where most weight loss was due to a reduction in fat mass while increasing lean mass

CINCINNATI–(BUSINESS WIRE)–CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity, today announced topline interim data from its Phase 1 single ascending dose (SAD) study of CIN-110 and final data from its multiple ascending dose (MAD) study of CIN-109, with both programs demonstrating tolerability and meaningful weight loss. CIN-110 is a novel, long-acting PYY_3-36 analog designed to significantly reduce gastrointestinal (GI) side effects following subcutaneous (SC) administration. CIN-109 is a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) analog with the potential to decrease appetite, maintain energy expenditure, and drive weight loss while preserving lean body mass.

“Despite limitations and side effects, weight loss drugs represent more than $6 billion in annual revenues globally, with projections reaching $150 billion by 2030. The compelling early-stage results from CIN-110 and CIN-109 lead us to believe we can overcome these limitations with next-generation approaches,” said CinRx Founder and Chief Executive Officer Jon Isaacsohn, M.D. “CIN-110’s ability to help safely and tolerably reduce caloric intake while quickly decreasing body weight after just a single dose distinguishes it as a high-potential candidate. Similarly, CIN-109’s significant impact on fat mass reduction and preservation of lean mass, especially at the highest doses, positions it as a powerful long-term solution.”

The interim data from the CIN-110 double-blind Phase 1 SAD study showed it was well-tolerated and demonstrated encouraging caloric intake decreases and resulting weight loss compared to placebo after a single SC dose. Within just one week of dosing, food intake decreased by up to 28%, and body weight dropped by as much as 1.8%. The study was conducted with 24 otherwise healthy obese participants with a mean baseline weight and body mass index (BMI) of ~102 kg and ~34 kg/m², respectively.

CIN-110 is specifically designed to increase and sustain drug exposure gradually, minimizing the gastrointestinal side effects commonly seen with rapid increases in PYY levels following subcutaneous dosing. In total, three cases of mild nausea were reported, typically occurring within 12-48 hours after dosing and resolving within a day, even while CIN-110 levels remained near their peak. Pharmacokinetic results showed that CIN-110 levels in the body rose gradually, with peak concentrations typically reached within two to three days after dosing. These levels were sustained with an approximate 14-day half-life. No participants withdrew from the CIN-110 study due to adverse events, and all side effects were mild or moderate, with the moderate being unrelated to the digestive system.

Results from the CIN-109 Phase 1 MAD study demonstrated it was well-tolerated and produced meaningful weight loss in the obese but otherwise healthy participants who completed the study. In the randomized, double-blind, placebo-controlled study, participants received CIN-109 once a week at doses of 5 mg, 10 mg, 15 mg, 20 mg, or 40 mg, or once every other week at doses of 20 mg, 40 mg, or 60 mg. The weekly group was treated for four weeks, while the group receiving CIN-109 every other week was treated for eight weeks. The mean weight and BMI of participants were ~100 kg and ~35 mg/m², respectively.

Participants experienced reductions in food intake, with dose-dependent decreases of up to 50%, and resulting weight loss of up to 3.7% within one to two months. Dosing every other week was better tolerated and the majority of weight lost represents fat mass. No serious side effects related to the treatment were observed.

About CIN-110:

CIN-110 is a potent, highly selective peptide YY (PYY_3-36) analog with an extended half-life, designed to significantly reduce the nausea and vomiting which has been observed with other PYY molecules while promoting effective, long-term weight loss. It is currently being evaluated in clinical trials to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The trials include single ascending dose (SAD) and multiple ascending dose (MAD) studies, with the MAD study building on the encouraging safety and tolerability data from the SAD study.

About CIN-109:

CIN-109 is a Phase 2 ready, a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) analog for the treatment of obesity. CIN-109 is a Phase 2 ready candidate after successfully completing a randomized, double-blind, placebo-controlled multiple-ascending-dose study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity delivered subcutaneously.

About CinFina Pharma:

CinFina Pharma, a CinRx portfolio company, is expanding the treatment options for obesity and its associated comorbidities with a pipeline of therapeutic candidates designed to be safe, tolerable, and durable to help people lose weight and keep it off to improve their overall health. CinFina’s four therapeutic candidates are naturally occurring peptides engineered for prolonged activity that send signals to the body to control insulin secretion or feelings of satiety. Learn more at www.CinFina.com.

About CinRx Pharma:

CinRx Pharma is a biotech company advancing a diverse portfolio of high-impact medicines through clinical development with a unique hub-and-spoke business model. CinRx’s approach combines financing with the efficient progression of therapeutic candidates within its portfolio, each managed by CinRx’s central infrastructure and operating team. Current CinCos address areas of high unmet medical need, including metabolic, gastrointestinal, and oncology. Differentiated by an asset selection process agnostic to therapeutic area, a strategic CRO partnership, and insights from thousands of development programs, CinRx identifies, funds, and accelerates promising drugs with the potential to have the highest impact on patients’ quality of life. CinRx Pharma is headquartered in Cincinnati, Ohio.

For more information, please visit www.CinRx.com or follow the company on X and LinkedIn.

Contacts

Media Contact:
Katherine Beach Oltsik

Account Director, Communications

katherine.beach@inizioevoke.com

CinRx Pharma Contact:
Jason Westerheide

Executive Director, Business Development

jwesterheide@CinRx.com

Butterfly Network Reports Third Quarter 2024 Financial Results




Butterfly Network Reports Third Quarter 2024 Financial Results

Delivered Quarterly Revenue of $20.6mm, 33% YoY Growth

Raises Full Year Revenue and Adjusted EBITDA Guidance

• Delivered quarterly Revenue of $20.6 million in Q3, representing 33% YoY growth
• Reduced Q3 Net Loss by 38% and Net Cash Used in Operations by 50%
• Launched iQ3 in Europe and opened new markets in Indonesia, the Netherlands, and Belgium
• Announced the formation of Octiv™, a wholly owned subsidiary focused on bringing Butterfly’s chip to new sectors

BURLINGTON, Mass. & NEW YORK–(BUSINESS WIRE)–$BFLY #POCUS—Butterfly Network, Inc. (NYSE: BFLY) (“Butterfly” or the “Company”), a digital health company transforming care with portable, semiconductor-based ultrasound technology and intuitive software, today announced financial results for the third quarter ended September 30, 2024, and provided a business update.

Joseph DeVivo, Butterfly’s President, Chief Executive Officer and Chairman commented, “The Butterfly team is proud to report a fifth consecutive quarter in which we met or exceeded expectations. Our third quarter delivered growth of 33% versus 2023, while reducing cash use to a historic low. This success came from consistent, repeatable execution across all channels, driven by great products and a dedicated team. We’ve caught our stride and continue to gain momentum; with this, we are pleased to be giving improved guidance today on the top and bottom line.

DeVivo continued, “What’s more, while delivering strong results today, the Butterfly team has also kept our eye on the future. We remain fully committed to the strategic growth pillars we introduced at our March 2024 Investor Day. We look forward to sharing details of our operational and strategic highlights during today’s conference call, including announcing new developments in our Butterfly HomeCare services business, and an exciting opportunity to fully capitalize on our Powered by Butterfly™ chip licensing program.”

Recent Operational and Strategic Highlights:

• Butterfly’s Return-on-Investment Validation: Published a case study demonstrating that University of Rochester Medical Center’s system-wide deployment of Butterfly is enhancing patient care and financial performance. Additional research by Dr. Stephen Erickson at Jefferson Healthcare shows Butterfly devices pay for themselves quickly for individual practitioners, as well.
• Medical Education Progress: Announced Kansas City University as the first U.S. medical school to leverage Butterfly ScanLab™ as the foundation of its POCUS curriculum.
• International Market Expansion: Launched Butterfly iQ3 in Europe, and opened new markets in Indonesia, the Netherlands, and Belgium.
• Butterfly Veterinary Advancements: Announced data from Kansas State University with Beef Cattle Institute on chute-side management of bovine respiratory disease, confirming the value of Butterfly in creating a new decision-making process for cattle operations globally.
• Butterfly Garden Growth: Signed two new Butterfly Garden partners, bringing the portfolio to 17 companies. On October 28, 2024, HeartFocus by Deski announced the commercial launch of its AI-powered cardiac training app.
• Butterfly HomeCare Pilot Announcement: In the fourth quarter 2024, Butterfly HomeCare is set to begin a pilot for virtual chronic care management with a leading Medicare Advantage provider to improve heart failure outcomes through AI-powered imaging.
• Octiv™ Subsidiary Formation Announcement: as a next step to monetize the full value of Powered by Butterfly™, the Company plans to form Octiv – a wholly-owned subsidiary dedicated to bringing Butterfly’s proprietary chip to new sectors. With the creation of Octiv, the Company’s goal is to increase access to capital from new investors, while unlocking value for current Butterfly shareholders.
• European Union’s Restriction of Hazardous Substances (RoHS) Update: Butterfly leadership met with the officials responsible for the RoHS exemptions revision on September 11, 2024 in Brussels. During the discussion, Butterfly’s revocation was welcomed with significant support from the European Commission representatives. Subsequently, on October 23, 2024, Butterfly re-submitted its revocation request, providing additional information and details suggested by the European Commission.

Three Months Ended September 30, 2024 Financial Results

Revenue: Total revenue was $20.6 million, up 33% from $15.4 million in the third quarter of 2023. U.S. revenue was $13.1 million, up 27% from prior year, driven by the recently launched next-generation iQ3 probe’s higher selling price and increased enterprise software revenue. International revenue increased 36% year-over-year to $5.2 million, with new geographies contributing revenue. Other revenue contributed $2.3 million.

• Product revenue was $13.5 million, an increase of 55% versus the prior year period, driven by the 37% increase in units fulfilled year-over-year and the iQ3’s higher selling price.
• Software and other services revenue was up 5% year-over-year at $7.0 million. Software and other services mix was 34% of revenue and decreased by 9 percentage points versus the prior year due to the higher product revenue achieved this quarter. Enterprise as a percentage of software revenue increased 5 percentage points year-over-year.

Gross profit: Gross profit was $12.2 million versus $9.4 million in the prior year period, and adjusted gross profit was $12.3 million versus $9.4 million in the prior period. Gross margin decreased to 59.5% from 60.8% in the prior year period, and adjusted gross margin decreased to 60.0% from 60.8% in the prior year period. These decreases are primarily due to the higher cost to manufacture iQ3 including efficiencies in starting a new line and warranty expense; product mix, reflecting a higher proportion of product revenues; and higher amortization which reduced margin by approximately 90 basis points, largely offset by higher average selling prices.

Operating expenses: Operating expenses were $29.5 million, down 30% from $41.9 million in the prior year period, due to previously announced reductions in force, as well as non-payroll spending rationalization across all areas.

Total operating expenses excluding stock-based compensation and Other expense were $23.4 million, compared to $25.9 million in the third quarter of 2023, representing a decrease of 10%.

Net loss: Net loss was $16.9 million, compared to $27.4 million in the prior year period.

Adjusted EBITDA: Adjusted EBITDA loss was $8.4 million, compared to $12.5 million in the prior year period.

Adjusted EPS: Adjusted EPS was ($0.05), compared to ($0.07) in the prior year period.

Cash, cash equivalents, and restricted cash: Cash, cash equivalents, and restricted cash were $97.8 million as of September 30, 2024.

Guidance

Increased Revenue Guidance and improved Adjusted EBITDA guidance for the Fiscal Year 2024 to:

• Revenue guidance of $79 million to $81 million or over 20% growth
• Improved adjusted EBITDA guidance by $5 million to a loss of $42 million – $40 million

Reconciliation of GAAP to Adjusted

Reconciliations of gross margin to adjusted gross margin and of net loss to adjusted EBITDA and adjusted EPS for the three and nine months ended September 30, 2024, and 2023 is provided in the financial schedules that are part of this press release. An explanation of these non-GAAP financial measures is also included below under the heading “Non-GAAP Financial Measures.”

Conference Call

A conference call and webcast to discuss third quarter 2024 financial performance and operational progress is scheduled for 8:00 am ET on November 1, 2024. The conference call will be broadcast live in listen-only mode via a webcast on Butterfly’s Investor Relations website at Events & Presentations. Individuals interested in listening to the conference call on your telephone may do so by dialing approximately ten minutes prior to start time:

US domestic callers: +1 (833) 470-1428

Global Dial-In Numbers: https://www.netroadshow.com/events/global-numbers?confId=71022
Access Code: 668983

After the live webcast, the call will be archived on Butterfly’s Investor Relations page. In addition, a telephone replay of the call will be available until November 15, 2024, by dialing:

U.S. (Toll-Free): +1 866-813-9403

U.S. / International (Tolled): +1 929-458-6194

Access Code: 736364

About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world’s first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second-generation Butterfly iQ+ in 2020, and third generation iQ3 in 2024 – each with increased processing power and performance enhancements. The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world. Butterfly devices are commercially available to trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, the Middle East, North America and South America; to learn more about available countries, visit: https://www.butterflynetwork.com/choose-your-country.

Non-GAAP Financial Measures

In addition to providing financial measures based on generally accepted accounting principles in the United States of America (“GAAP”), we provide additional financial measures that are not prepared in accordance with GAAP (“non-GAAP”). The non-GAAP financial measures included in this press release are adjusted gross profit, adjusted gross margin, adjusted EBITDA, and adjusted EPS. We present non-GAAP financial measures in order to assist readers of our financial statements in understanding the core operating results that our management uses to evaluate the business and for financial planning purposes. Our non-GAAP financial measures provide an additional tool for investors to use in comparing our financial performance over multiple periods.

The non-GAAP financial measures included in this press release are key performance measures that our management uses to assess our operating performance. These non-GAAP measures facilitate internal comparisons of our operating performance on a more consistent basis. We use these performance measures for business planning purposes and forecasting. We believe that these non-GAAP measures enhance an investor’s understanding of our financial performance as they are useful in assessing our operating performance from period-to-period by excluding certain items that we believe are not representative of our core business.

The non-GAAP financial measures included in this press release may not be comparable to similarly titled measures of other companies because they may not calculate these measures in the same manner. These non-GAAP financial measures are not prepared in accordance with GAAP and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. When evaluating the Company’s performance, you should consider adjusted gross profit, adjusted gross margin, adjusted EBITDA, and adjusted EPS alongside other financial performance measures prepared in accordance with GAAP, including gross profit, gross margin, net loss, and EPS.

The non-GAAP financial measures do not replace the presentation of our GAAP financial results and should only be used as a supplement to, not as a substitute for, our financial results presented in accordance with GAAP. In this press release, we have provided reconciliations of adjusted gross profit to gross profit, adjusted gross margin to gross margin, and adjusted EBITDA and adjusted EPS to net loss, the most directly comparable GAAP financial measures. Reconciliations of our non-GAAP financial measures to corresponding GAAP measures are not available on a forward-looking basis because we are unable to predict with reasonable certainty the non-cash component of employee compensation expense, changes in our working capital needs, variances in our supply chain, the impact of earnings or charges resulting from matters we consider not to be reflective, on a recurring basis, of our ongoing operations, and other such items without unreasonable effort. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP. Management strongly encourages investors to review our financial statements and publicly filed reports in their entirety and not to rely on any single financial measure.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Our actual results may differ from our expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, our expectations with respect to financial results, future performance, commercialization and plans to deploy our products and services, development of products and services, and the size and potential growth of current or future markets for our products and services. Forward-looking statements are based on our current beliefs and assumptions and on information currently available to us. These forward-looking statements involve significant known and unknown risks and uncertainties and other factors that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside our control and are difficult to predict. Factors that may cause such differences include, but are not limited to: our ability to grow and manage growth effectively; the success, cost, and timing of our product and service development activities; the potential attributes and benefits of our products and services; the degree to which our products and services are accepted by healthcare practitioners and patients for their approved uses; our ability to obtain and maintain regulatory approval for our products, and any related restrictions and limitations of any approved product; our ability to identify, in-license, or acquire additional technology; our ability to maintain our existing license, manufacturing, supply, and distribution agreements; our ability to compete with other companies currently marketing or engaged in the development of products and services that we are currently marketing or developing; changes in applicable laws or regulations; the size and growth potential of the markets for our products and services, and our ability to serve those markets, either alone or in partnership with others; the pricing of our products and services, and reimbursement for medical procedures conducted using our products and services; our estimates regarding expenses, revenue, capital requirements, and needs for additional financing; our financial performance; our ability to raise financing in the future; and other risks and uncertainties indicated from time to time in our most recent Annual Report on Form 10-K or in subsequent filings that we make with the Securities and Exchange Commission. We caution that the foregoing list of factors is not exclusive. We caution you not to place undue reliance upon any forward-looking statements, which speak only as of the date of this press release. We do not undertake or accept any obligation or undertake to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions, or circumstances on which any such statement is based.

Contacts

Investors

Heather Getz

Chief Financial and Operations Officer, Butterfly

investors@butterflynetwork.com

Read full story here

Exact Sciences to Participate in November Investor Conference




Exact Sciences to Participate in November Investor Conference

MADISON, Wis.–(BUSINESS WIRE)–Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that company management will participate in the following conference and invited investors to participate by webcast.

• Jefferies London Healthcare Conference, London
  
  Fireside chat on Tuesday, November 19, 2024 at 6:00 a.m. ET

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

Contacts

Erik Holznecht

Exact Sciences Corp.

investorrelations@exactsciences.com
608-800-6605