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Philips presents study results at Heart Rhythm Annual Meeting demonstrating benefits of its AI-powered cardiac monitoring solutions

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Philips presents study results at Heart Rhythm Annual Meeting demonstrating benefits of its AI-powered cardiac monitoring solutions




Philips presents study results at Heart Rhythm Annual Meeting demonstrating benefits of its AI-powered cardiac monitoring solutions

May 17, 2024

Three studies demonstrate how Philips MCOT wearable ambulatory monitoring ECG and proprietary AI models applied to ECG digital biomarkers can help to improve diagnosis, reduce readmissions, and lower costs

Amsterdam, the Netherlands and Boston, USA – Royal Philips (NYSE: PHG, AEX: PHIA) a global leader in health technology, is presenting new retrospective study results demonstrating the clinical and economic benefits of Philips’ AI-powered cardiac care solutions at the Heart Rhythm Annual Meeting in Boston (May 16-19).

With cardiovascular disease on the rise, clinicians and health systems continue to look for ways to deliver high-quality care that is both timely and cost-effective. Findings from the three studies highlight the central role mobile cardiac monitoring technology plays in supporting early detection of adverse cardiac events and enabling potentially life-saving interventions for patients, while helping to reduce readmissions and lower costs.

Recently published in The Journal of Comparative Effectiveness Research, a Philips study compares the clinical and economic outcomes of using the Philips mobile cardiac outpatient telemetry (MCOT) wearable ECG sensor with implantable loop recorders (ILRs) in stroke patients to determine how cardiac remote monitoring technology impacts current standards of care. This study analyzed the eighteen months following a stroke event and found that when MCOT was used instead of ILR for post-discharge monitoring:

  • Patients experienced significantly lower readmissions (30.2% in the MCOT-monitored group compared to 35.4% in the ILR group);
  • Average cost over an 18-month period following the stroke event was reduced by USD 27,429;
  • Emergency department utilization was significantly lower;
  • Patients with complications and comorbidities from the index stroke experienced a higher rate of survival.

Manish Wadhwa, Chief Medical Officer for Philips Ambulatory Monitoring & Diagnostics, said: “As we explore how specific ambulatory monitoring devices, like MCOT, impact clinical outcomes, data demonstrates that choice of monitoring modality does affect the cost-effectiveness of care and patient outcomes. Effective cardiac monitoring starts with quality data, and with the AI-powered data platform behind MCOT, Philips is uniquely positioned to help care teams make quick, impactful, and cost-conscious decisions for their cardiac patients.”

On Saturday, May 18 at 3 p.m., Philips will host a moderated discussion about the comparative outcomes and cost of ILR and MCOT following stroke with electrophysiologist Dr. Mohammad-Ali Jazayeri in booth #1135.

Two poster presentations will highlight additional recent research showcasing Philips’ impact on improved health outcomes and AI-driven diagnosis:   

  • Back to the Future: Artificial intelligence applied to ECG can help identify life-threatening arrhythmia events at the roots
    The cause of syncope, a loss of consciousness or fainting, is difficult to diagnose and the condition leads to approximately 3% of all visits to the emergency room. Syncope may be caused by a serious heart condition and cardiac monitoring solutions are often used to detect adverse heart rate and/or rhythm events to improve how syncope patients are diagnosed and managed.

    AI and deep neural network (DNN) algorithms have demonstrated the ability to provide accurate medical diagnoses equivalent to human physicians or conventional algorithms. Philips’ study reveals that AI-powered ECG biomarker technology may help to identify patients with significant intermittent bradyarrhythmia, potentially improving timely diagnosis and management. Using an AI-based learning model, the study focused on successfully triaging syncope patients by identifying those who had previously experienced bradyarrhythmia.

    Dr. Laurent Fiorina, Cardiovascular Institute Paris-Sud (ICPS) and medical advisor for Philips, said: “Our main focus is developing new AI models to detect cardiovascular conditions or predict future cardiac events like atrial fibrillation, ventricular tachycardia, and now, severe bradyarrhythmia.”

    Join Dr. Fiorina and Philips between 3:30 and 5:30 p.m. ET on Friday, May 17 in the HRS Abstract area to learn more about this study and its impact on the future of cardiac care.

  • The EP-COT Trial: Impact of Emergent Physician Notifications from MCOT on Patient Outcomes
    While ambulatory cardiac monitors are frequently used to diagnose arrhythmias, their impact on clinical decision-making has not been extensively studied. When examining how MCOT impacts acute clinical management decisions, Dr. David Lin at the University of Pennsylvania and Dr. Mathew Hutchinson at the University of Arizona found that patients who had Emergent Notifications while wearing a Philips MCOT had a high degree of symptom-arrhythmia correlation and that these notifications were delivered to the care provider. The notifications initiated unscheduled follow-up care in over 85% of patients and a procedural intervention in over 25%, indicating MCOT’s effectiveness in detecting actionable arrhythmias and enabling care teams to intervene and provide necessary care.

    Dr. David Lin, Cardiologist at the University of Pennsylvania Hospital, will present these trial findings in further detail in the HRS Abstract Area between 3:30 and 5:30 p.m. ET.

Lead Management and CIED Infection
Philips will also continue to educate on cardiac implantable electronic device (CIED) infections to improve the quality of patient care by ensuring physicians are knowledgeable about CIED infection treatment and guidelines. Philips supports physicians with Lead Management solutions through a broad portfolio of tools designed for safety and predictability, including both laser and mechanical lead extraction devices to help indicated patients get the quick and effective treatment they deserve.

On Friday, May 17th, Philips will host a Rhythm Theater in partnership with Medtronic on the prevention, identification, and management of CIED infections in Rhythm Theater #1 at 11:00 am ET.

Additional details on clinical presentations at the show on behalf of Philips can be viewed here. For more information on Philips’ presence at HRS, join in person at booth #1135 in the Boston Convention and Exhibition Center or visit Heart Rhythm 2024. Follow #HRS2024 for updates throughout the event.

For further information, please contact:

Meredith Amoroso
Philips External Relations
Tel: +1 724-584-8991
E-mail: meredith.amoroso@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency

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QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency




QuTEM Receives GMP Certificates and Manufacturing Permits for Transmission Electron Microscopy Laboratory from the Swedish Medical Products Agency

STOCKHOLM, Sweden, May 17, 2024 (GLOBE NEWSWIRE) — QuTEM AB (formerly Vironova BioAnalytics AB), a leading provider of transmission electron microscopy (TEM) services, proudly announces the receipt of GMP (Good Manufacturing Practice) Certificates and Manufacturing Permits for Independent Quality Control Laboratories issued by the Swedish Medical Products Agency (Läkemedelsverket). QuTEM is thereby authorized to perform critical quality control analysis essential for the release of medicines to the market. The GMP Certificates and Manufacturing Permits cover medicinal and investigational medicinal products for both human and veterinary use.

GMP regulations are formal standards established by regulatory bodies worldwide to ensure the quality, safety, and efficacy of pharmaceutical products. Manufacturing Permits for Independent Quality Control Laboratories are granted by the Swedish regulatory authority since January 2024 to laboratories that conduct tests directly impacting the release of medicines. The GMP certificates and manufacturing permits are a testament to QuTEM’s commitment to biopharma drug development and quality control through cutting-edge electron microscopy technology.  

As quoted on the GMP certificates by the Swedish Medical Products Agency, QuTEM enables: “Quality control of micro- and nanoparticles through transmission electron microscopy (TEM) with the techniques of staining (negative stain) and freezing (cryogenic) and with semi-automatic particle detection and analysis using software”. The endorsement from regulatory authorities underscores QuTEM’s position as a trusted partner in the pharmaceutical industry, equipped to meet stringent regulatory requirements.

Dr. Josefina Nilsson, CEO of QuTEM, expressed enthusiasm about the achievement, stating, “QuTEM’s predecessor, Vironova BioAnalytics, made history as the world’s first and only GMP certified electron microscopy laboratory in 2020. Since then, we have been providing GMP level TEM services. To this moment, we proudly maintain our position as the only provider of electron microscopy services holding a GMP certificate. Our clients are consistently impressed by our advanced laboratory, top-tier experts, and high service standards. They benefit through the preparation of accurate and reproducible image datasets, the generation of reliable quantitative data, and the robust conclusions from the analysis. Acquiring the GMP certificates and manufacturing permits signifies not only a seamless transition in business and quality assurance from Vironova BioAnalytics to QuTEM, but also showcases our adaptability in maintaining quality standards amidst evolving regulatory requirements.”

For more information about QuTEM and its GMP certified electron microscopy services, visit www.qutem.com.

Contact information

Josefina Nilsson, Ph.D.
CEO
josefina.nilsson@qutem.com
+46 76 109 01 91

About QuTEM

QuTEM offers market-leading and unique analysis to researchers, developers and manufacturers of advanced therapeutics. QuTEM has an impressive range of clients across academia, SME biopharma companies, big pharma, CDMOs and CROs. With a commitment to quality and precision, the company supports pharmaceutical companies in their research, development, and quality control efforts.

QuTEM’s unique capabilities include:

– Offering an extensive service portfolio including a wide range of analyses e.g., AAVs, adenoviral vectors, lentivirus, VLPs, LNPs, liposomes, etc., to support biopharma needs.

– Highly accurate determination of capsid size distribution, going far beyond full/empty analysis and providing highly accurate measurements of capsid content down to numbers of kilobase pairs.

– GMP compliance: QuTEM has been granted the GMP certificates by the Swedish Medical Products Agency in April 2024.  All workflows, software and data handling are performed with full GMP compliance.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

Original-Research: Cantourage Group SE (von NuWays AG)

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Original-Research: Cantourage Group SE - from NuWays AG

Classification of NuWays AG to Cantourage Group SE

Company Name: Cantourage Group SE
ISIN: DE000A3DSV01

Reason for the research: Update
Recommendation: Kaufen
from: 17.05.2024
Target price: EUR 10.00
Target price on sight of: 12 months
Last rating change: 
Analyst: Christian Sandherr

Solid FY23 and Q1'24 prelims // accelerating growth in April; chg.
 
Topic: Cantourage issued solid FY23 and Q1 2024 prelims, which were
impacted by slower patient growth amid the looming (at that time)
regulatory changes. Sales figures for April (following legalization light)
show a significant acceleration.
 
FY23 sales grew by 67% yoy to € 23.6m (preliminary figures), slightly below
our estimate of € 24.7m as Q4 grew 'only' 30% yoy to € 6.4m vs the expected
50% to € 7.5m. To a large degree, this can be explained by a slower patient
growth in anticipation of the at that time looming Cannabis Act. FY23
EBITDA came in at € - 0.5m following a roughly € 400k loss after the first
nine months. The implied € 100k loss in Q4 is despite the slowed growth.
Management guided for high double-digit percentage sales growth and and at
least break-even EBITDA.
 
Legalization light tailwinds kicking in. While Q1 (on preliminary basis)
started out with “only” 26% yoy sales growth to € 6.2m, April (the first
month following the changes from the Cannabis Act) has already shown a
significant acceleration to 160%, which can be traced back to cannabis no
longer being considered a narcotic, notably simplifying dispensing by
pharmacies and prescriptions by doctors. Receiving a prescription for
medical cannabis has become as easy as for ibuprofen 600. While it is
difficult to reliably access the detailed impact on FY growth, we feel
comfortable with our estimated growth acceleration carried by Cantourage's
broad global supplier network with more than 60 grower partners and its own
recently launched telemedicine platform, telecan°.
 
Accordingly, we expect sequential growth during the coming quarters as the
number of medical cannabis patients is seen to surge. Mind you, in Canada,
the number of medial cannabis patients grew from 24k in 2015 to 330k in
2018, the year of the full legalization and Germany had roughly 4m cannabis
users in 2021 with the majority buying from black markets.
 
While management has not issued a FY24 guidance yet, we expect them to do
so once the company is able to better assess the sustainable impact from
the Cannabis Act, likely with H2 figures, in our view.
 
We confirm our BUY rating with a € 10 PT (old: € 11), based on DCF.

You can download the research here:
http://www.more-ir.de/d/29797.pdf
For additional information visit our website
www.nuways-ag.com/research.

Contact for questions
NuWays AG - Equity Research
Web: www.nuways-ag.com
Email: research@nuways-ag.com
LinkedIn: https://www.linkedin.com/company/nuwaysag
Adresse: Mittelweg 16-17, 20148 Hamburg, Germany
++++++++++
Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.
Offenlegung möglicher Interessenskonflikte nach § 85 WpHG beim oben analysierten Unternehmen befinden sich in der vollständigen Analyse.
++++++++++

-------------------transmitted by EQS Group AG.-------------------


The issuer is solely responsible for the content of this research.
The result of this research does not constitute investment advice
or an invitation to conclude certain stock exchange transactions.

Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise

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Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise




Erasca Announces Strategic In-Licensing of RAS-Targeting Franchise

Pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 are potent, oral inhibitors with potential best-in-class profiles in RASm solid tumors

Pipeline prioritization and workforce restructuring sharpens focus on programs targeting the highest unmet needs and with highest probability of success

Priced concurrent $160 million equity offering

Erasca to host conference call and webcast Friday, May 17, 2024 at 8:30 am ET

SAN DIEGO, May 16, 2024 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced it has entered into exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001)—and provided a pipeline update. ERAS-0015 and ERAS-4001 are highly potent, orally bioavailable molecules with complementary RAS inhibitory mechanisms that have the potential to address unmet needs in nearly 2.7 million patients who are diagnosed annually globally with RAS-mutant (RASm) tumors, of which over 2.2 million patients are diagnosed with KRAS-mutant (KRASm) tumors.

As separately announced, Erasca has priced an equity offering of $160 million with a high quality group of new and existing healthcare-focused investors.

“We’re thrilled to add ERAS-0015 and ERAS-4001 to our pipeline. Successful in-licensing of this RAS-targeting franchise with such broad potential to address unmet needs in patients helps advance our mission to erase cancer and is consistent with our focus on eradicating RAS/MAPK pathway-driven tumors,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Based on the compelling preclinical data generated to date, we believe both molecules have the potential to demonstrate best-in-class (BIC) profiles within their respective categories of RAS inhibition. Over the long term, we have a unique opportunity to combine these two BIC molecules with distinct and complementary RAS inhibitory mechanisms to ‘clamp’ RAS and shut down MAPK signaling for the benefit of patients with these common RAS mutations.”

Dr. Lim continued, “With the in-licensing of these RAS-targeting programs, we have made the difficult but necessary decision to deprioritize or externalize resourcing of our pipeline (ERAS-007, ERAS-801, and ERAS-4). This change has unfortunately impacted certain team members. We believe that further focusing our resources will allow us to advance the programs with the highest probability of success and largest potential for patient impact. This is undoubtedly a challenging time for our highly talented employees, particularly those affected by these changes. On behalf of Erasca, I would like to extend our heartfelt gratitude to all of our employees for their tremendous contributions and dedication to Erasca.”

In-Licensed Programs: ERAS-0015 and ERAS-4001
In controlled preclinical studies using another pan-RAS molecular glue currently in clinical development, ERAS-0015 demonstrated 5- to 10-fold greater in vitro and in vivo potency and favorable absorption, distribution, metabolism, and excretion (ADME) properties and pharmacokinetic (PK) properties in multiple animal species. Under the terms of the ERAS-0015 license agreement, in exchange for an exclusive license to develop and commercialize ERAS-0015 in the Erasca territory (worldwide, excluding mainland China, Hong Kong, and Macau), Erasca will pay the licensor, Joyo Pharmatech Co., Ltd. (Joyo), a one-time upfront cash payment of $12.5 million, up to $176.5 million in cash upon the achievement of certain development, regulatory, and commercialization milestones, and a low- to mid-single digit percentage royalty. At Erasca’s election, prior to the dosing of the first patient in a Phase 2 clinical trial by either Erasca or Joyo or the filing of a New Drug Application (NDA) (or foreign equivalent) by either Erasca or Joyo, Erasca can convert its territory to worldwide by making a one-time payment.

ERAS-4001 is a potent and selective inhibitor of KRAS that has the potential to provide an improved therapeutic window relative to RAS inhibitors and prevent KRAS wildtype-mediated resistance relative to mutant-selective approaches. Under the terms of the ERAS-4001 license agreement, in exchange for an exclusive worldwide license to develop and commercialize ERAS-4001, Erasca will pay the licensor, Medshine Discovery, Inc. (Medshine), a one-time upfront cash payment of $10.0 million, up to $160.0 million in cash upon the achievement of certain development, regulatory, and commercialization milestones, and a low-single digit percentage royalty.

Concurrent Pipeline Prioritization and Workforce Restructuring
In consideration of these in-licensing transactions, Erasca will implement the following pipeline and personnel changes to focus Erasca’s resources on opportunities targeting the highest unmet needs and having the highest probability of success for patients:

  • HERKULES-3: ERAS-007 + EC in EC-naïve patients with BRAFm CRC: Deprioritized as clinical efficacy data (data to be presented at ASCO 2024) do not support continued evaluation
  • THUNDERBBOLT-1: ERAS-801 in recurrent glioblastoma: Due to the desire to focus internal resources on developing naporafenib and the RAS-targeting franchise, Erasca is exploring further advancement of ERAS-801 via select investigator-sponsored trial(s)
  • ERAS-4 pan-KRAS program: In conjunction with the in-licensing of ERAS-0015 and ERAS-4001, Erasca will discontinue its internal pan-KRAS program; provided that certain of the existing ERAS-4 molecules are included in the Medshine agreement as potential backup compounds for ERAS-4001
  • Workforce restructuring: Erasca will reduce its workforce by approximately 18%, primarily affecting employees working in drug discovery functions and on deprioritized programs. Erasca is deeply committed to easing this transition for its impacted colleagues and will offer comprehensive severance packages and career transition services

Key Upcoming Milestones
Erasca is providing the following guidance with respect to anticipated key milestones and clinical trial readouts:

  • Naporafenib (pan-RAF inhibitor)
    • SEACRAFT-1: Phase 1b trial for naporafenib plus trametinib in patients with RAS Q61X solid tumors
      • Initial Phase 1b combination signal-seeking efficacy data in relevant tumor types expected in Q4 2024
    • SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma
      • Phase 3 pivotal trial initiation expected in Q2 2024
      • Phase 3 Stage 1 randomized dose optimization data expected in 2025
  • ERAS-0015 (pan-RAS molecular glue)
    • AURORAS-1: Phase 1 trial for ERAS-0015 in patients with RASm solid tumors
      • IND filing expected in H1 2025
      • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026
  • ERAS-4001 (pan-KRAS inhibitor)
    • BOREALIS-1: Phase 1 trial for ERAS-4001 in patients with KRASm solid tumors
      • IND filing expected in Q1 2025
      • Initial Phase 1 monotherapy data in relevant tumor types expected in 2026

Conference Call and Webcast Information
Erasca will hold a conference call and webcast Friday, May 17, 2024 at 8:30 am ET. The webcast link for the conference call is https://viavid.webcasts.com/starthere. The dial-in number is 1-877-451-6152 (U.S./Canada) or 1-201-389-0879 (international). The conference ID for all callers is 13746639. The live webcast and replay may be accessed by visiting Erasca’s website at Erasca.com/events.

About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates, including naporafenib, ERAS-0015, ERAS-4001, and ERAS-801; the potential benefits from our current or future arrangements with third parties, including the anticipated benefits of the license agreements with Medshine Discovery Inc. and Joyo Pharmatech Co., Ltd.; the planned advancement of our development pipeline, including the anticipated timing of data readouts for the SEACRAFT-1, SEACRAFT-2, AURORAS-1, and BOREALIS-1 trials, the initiation of the SEACRAFT-2 trial, and the IND filings for the AURORAS-1 and BOREALIS-1 trials; our ability to successfully prioritize our pipeline portfolio to focus on existing programs that we believe have the highest probability of success; and our ability to realize the benefits of the license agreements described in this press release. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; our assumptions about ERAS-0015 or ERAS-4001 development potential are based in large part on the preclinical data generated by the licensors and we may observe materially and adversely different results as we conduct our planned studies; we only have one product candidate in clinical development and all of our other development efforts are in the preclinical or development stage; our planned SEACRAFT trials may not support the registration of naporafenib; our assumptions around which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; potential delays in the commencement, enrollment, data readout, and completion of clinical trials and preclinical studies; our dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; the inability to realize any benefits from our current licenses, acquisitions, or collaborations, and any future licenses, acquisitions, or collaborations, and our ability to fulfill our obligations under such arrangements; regulatory developments in the United States and foreign countries; later developments with the FDA or EU health authorities may be inconsistent with the feedback received to date regarding our development plans and trial designs; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Source: Erasca, Inc.

Erasca Announces Pricing of Underwritten Offering of Common Stock

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Erasca Announces Pricing of Underwritten Offering of Common Stock




Erasca Announces Pricing of Underwritten Offering of Common Stock

SAN DIEGO, May 16, 2024 (GLOBE NEWSWIRE) — Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the pricing of an underwritten offering of 86,486,486 shares of its common stock at a price of $1.85 per share. All of the shares to be sold in the offering are to be sold by Erasca. The gross proceeds to Erasca from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $160 million. In addition, Erasca has granted the underwriters a 30-day option to purchase up to an additional 12,972,972 shares of common stock at the offering price. The offering is expected to close on May 21, 2024, subject to the satisfaction of customary closing conditions.

Erasca intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities, to fund the research and development of its product candidates and other development programs and for working capital and other general corporate purposes.

J.P. Morgan and BofA Securities are acting as joint book-running managers for the offering.

The securities described above are being offered by Erasca pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with the Securities and Exchange Commission (SEC) and was declared effective on August 18, 2022. A prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; or BofA Securities, NC1-022-02-25 Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC, 28255-0001, or by email at dg.prospectus_requests@bofa.com. Electronic copies of the prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of patients with cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipeline in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.

Forward Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the expected closing of the offering and the anticipated use of proceeds therefrom. Actual results may differ from those set forth in this press release due to the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the offering, as well as risks and uncertainties inherent in our business described in our prior filings with the SEC, including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Source: Erasca, Inc.

HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress

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HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress




HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress

HONG KONG, SHANGHAI and FLORHAM PARK, N.J., May 17, 2024 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (“EHA”) Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online.

ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in adult patients with primary Immune Thrombocytopenia (“ITP”) who have received at least one prior line of standard therapy (NCT05029635). In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p<0.0001). The median time to response was 1.1 weeks with sovleplenib. It demonstrated a tolerable safety profile with grade 3 or above treatment-emergent adverse events (TEAEs) in 25.4% of patients with sovleplenib and 24.2% with placebo. Sovleplenib also significantly improved quality of life in physical functioning and energy/fatigue (p<0.05).

Most patients were heavily pretreated with a median of four prior lines of ITP therapy and a majority (71.3%) of the patients had received prior TPO/TPO-RA1 treatment. Further post-hoc subgroup analysis of the study demonstrated consistent clinical benefits across ITP patients regardless of prior lines of ITP therapies or prior TPO/TPO-RA exposure, regardless of TPO/TPO-RA treatment types and number of prior regimens.

In addition to the promising data in ITP, results from Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) will also be presented at the congress demonstrating encouraging hemoglobin (Hb) benefit compared with placebo, with overall response rate of 43.8% vs. 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo). A favorable safety profile was also demonstrated.

Details of the presentations are as follows:

Abstract title Presenter / Lead author Presentation details
Efficacy and Safety of The Syk Inhibitor Sovleplenib (HMPL-523) in Adult Patients with Primary Immune Thrombocytopenia in China (ESLIM-01): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Renchi Yang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China		 #S316
Oral Presentation (Platelet disorders in the spotlight: Clinical and translational)
Friday, June 14, 2024
15:00 – 15:15 CEST, Hall Mallo
Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Results from the Randomized, Double-Blind, Placebo-Controlled, Phase 2 Part of the Study Fengkui Zhang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China		 #S297
Oral Presentation (Thalassemias and rare anemias)
Sunday, June 16, 2024
12:00 – 12:15 CEST, Hall Mallo
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Patients by Prior Lines of Therapy: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) Xiaofan Liu
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China

 #P1629
Poster Session
Friday, June 14, 2024
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with Prior TPO/TPO-RA Treatment: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) Heng Mei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

 #P1631
Poster Session
Friday, June 14, 2024
Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Hodgkin Lymphoma Patients Paolo Strati
The University of Texas MD Anderson Cancer Center, Houston, U.S.

 #P1102
Poster Session
Friday, June 14, 2024
HMPL-306 in Patients with Relapsed or Refractory Myeloid Hematological Malignancies Harboring IDH1 and/or IDH2 Mutations: Final Result of Dose Expansion in Phase 1 Study Xiaojun Huang
Peking University People’s Hospital, Beijing, China		 #P532
Poster Session
Friday, June 14, 2024
Phase 1 Study of HMPL-306 in Patients with Advanced Acute Myeloid Leukemia with Isocitrate Dehydrogenase (IDH) Mutations: Preliminary Results of the Dose Escalation Cohorts Pau Montesinos
Hospital Universitario La Fe, Valencia, Spain		 #P549
Poster Session
Friday, June 14, 2024
Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Inhibitor, in Patients with Relapsed/Refractory Lymphomas Mingci Cai
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

 #P2080
e-Poster Presentation
Friday, June 14, 2024
Results from a Phase 1 Dose Escalation Study of HMPL-760, a Third Generation, Highly Selective, Reversible BTK Inhibitor in Chinese Patients with Relapsed/Refractory (R/R) Lymphomas Ying Qian
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

 #P2054
e-Poster Presentation
Friday, June 14, 2024
A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia

 Waleed Ghanima
University of Oslo, Oslo, Norway		 #PB3341
Publication Only
     

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of sovleplenib, HMPL-306, HMPL-760 and tazemetostat, the further clinical development for sovleplenib, HMPL-306, HMPL-760, tazemetostat and amdizalisib, its expectations as to whether any studies on sovleplenib, HMPL-306, HMPL-760, tazemetostat and amdizalisib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of sovleplenib, HMPL-306, HMPL-760, tazemetostat and amdizalisib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of sovleplenib, HMPL-306, HMPL-760 and tazemetostat for a targeted indication, and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Nominated Advisor  
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500

________________________________

REFERENCES

1 TPO = Thrombopoietin; TPO-RAs = Thrombopoietin receptor agonists.

AVITA Medical to Host Investor Webinar Briefing

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AVITA Medical to Host Investor Webinar Briefing




AVITA Medical to Host Investor Webinar Briefing

VALENCIA, Calif., May 16, 2024 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O’Toole, Chief Financial Officer, on May 21, 2024, at 4:00 p.m. Pacific Daylight Time / May 22, 2024, at 9:00 a.m. Australian Eastern Standard Time.

The webinar presentation will cover financial and business results from our recent first quarter 2024 earnings webcast and conclude with a Q&A session.

To register for the presentation, please follow this Zoom link:
https://us02web.zoom.us/webinar/register/5817086771005/WN_yN29KwqiQiWKgx9HPMzaSg

Participants are invited to submit questions via the registration page or during the webinar via the chat function. A replay will be available on the AVITA Medical website, ir.avitamedical.com, following the presentation.

About AVITA Medical, Inc.
AVITA Medical® is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States.

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, has received CE-mark approval in Europe, and has PMDA approval in Japan.

To learn more, visit www.avitamedical.com.

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

CONTACT: Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com

BioSyent Releases Financial Results for Q1 2024

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BioSyent Releases Financial Results for Q1 2024




BioSyent Releases Financial Results for Q1 2024

MISSISSAUGA, Ontario, May 16, 2024 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q1) ended March 31, 2024. Key highlights include: 

(CAD) Q1 2024 % Change vs.
Q1 2023		 Trailing Twelve Months
(TTM)
March 31, 2024		 % Change vs.
TTM
March 31, 2023
Canadian Pharma Sales 7,546,144 18 % 30,689,349 16 %
International Pharma Sales – 0 % 1,047,747 789 %
Total Company Sales 7,733,636 19 % 32,841,244 20 %
EBITDA1 2,204,193 45 % 8,614,037 28 %
Net Income After Taxes (NIAT) 1,768,727 50 % 7,053,608 40 %
Fully Diluted EPS 0.15 50 % 0.59 44 %
             
  • Return on Equity for TTM March 31, 2024 was 21% as compared to 15% for TTM March 31, 2023
  • During Q1 2024, repurchased for cancellation a total of 156,200 common shares under a Normal Course Issuer Bid (NCIB)
  • Paid quarterly cash dividends of $0.045 per common share on March 15, 2024, an increase of 12.5% from the previous quarterly dividend

“Our Canadian pharmaceutical business got off to a fast start in Q1 2024 with 18% revenue growth over the comparative period,” said René Goehrum, President and CEO of BioSyent. “All of our Canadian pharmaceutical brands contributed to this growth during the quarter. Our three launch brands, FeraMAX® Pd Maintenance 45, Inofolic®, and Gelclair® also contributed modest incremental growth during Q1 2024. We remain focused on continuing to grow our Canadian pharmaceutical business during the remainder of the year with continued selling and promotional investment in our launch brands. I look forward to reporting on our progress in 2024.”

The CEO’s presentation on the Q1 2024 Results is available at the following link: www.biosyent.com/investors/

The Company’s Interim Unaudited Condensed Consolidated Financial Statements and Management’s Discussion and Analysis for the three months ended March 31, 2024 and 2023 will be posted on www.sedarplus.ca on May 16, 2024.

For a direct market quote for the TSX Venture Exchange and other Company financial information, please visit www.tmxmoney.com.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its community, specialty and international business units.

As of the date of this press release, the Company has 11,585,169 common shares outstanding.

BioSyent Inc.
Interim Unaudited Condensed Consolidated Statements of Comprehensive Income
       
In Canadian Dollars Q1 2024   Q1 2023   % Change  
Net Revenues 7,733,636   6,482,694   19%  
Cost of Goods Sold 1,589,762   1,147,962   38%  
Gross Profit 6,143,874   5,334,732   15%  
Operating Expenses and Finance Income/Costs 3,737,443   3,735,758   0%  
Net Income Before Tax 2,406,431   1,598,974   50%  
Tax (including Deferred Tax) 637,704   423,728   50%  
Net Income After Taxes 1,768,727   1,175,246   50%  
Net Income After Taxes % to Net Revenues 23%   18%    
EBITDA 2,204,193   1,516,634   45%  
EBITDA % to Net Revenues 29%   23%    
           
  1. EBITDA is a Non-IFRS Financial Measure. The term EBITDA does not have any standardized meaning under International Financial Reporting Standards (IFRS) and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest income or expense, income taxes, depreciation and amortization.

BioSyent Inc.
Interim Unaudited Condensed Consolidated Statements of Financial Position
 
       
AS AT       March 31, 2024 December 31, 2023 % Change
ASSETS      
       
Cash, cash equivalents and short-term investments $ 23,687,796 $ 26,187,011 -10 %
Trade and other receivables   2,791,794   3,477,096 -20 %
Inventory   5,718,882   5,894,495 -3 %
Derivative asset   11,550   – 100 %
Prepaid expenses and deposits   569,144   243,460 134 %
Loans receivable – current   73,452   69,419 6 %
CURRENT ASSETS   32,852,618   35,871,481 -8 %
       
Long term investments   4,106,547   2,500,000 64 %
Loans receivable – non current   205,182   205,182 0 %
Deferred tax asset   343,607   359,470 -4 %
Property and equipment   1,373,868   1,439,930 -5 %
Intangible assets   1,114,612   1,152,876 -3 %
TOTAL NON CURRENT ASSETS   7,143,816   5,657,458 26 %
TOTAL ASSETS $ 39,996,434 $ 41,528,939 -4 %
       
LIABILITIES AND SHAREHOLDERS’ EQUITY      
       
CURRENT LIABILITIES $ 4,256,689 $ 5,533,850 -23 %
NON CURRENT LIABILITIES   1,187,820   1,235,333 -4 %
Long term debt   –   – 0 %
Total Equity   34,551,925   34,759,756 -1 %
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 39,996,434 $ 41,528,939 -4 %
 

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals. Neither 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 press release.

Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause

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Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause




Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause

Late-breaking data from pivotal Phase III studies OASIS 1 and 2 to be presented at 2024 ACOG Annual Meeting:


  • Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms (VMS; also known as hot flashes) over 12 weeks compared to placebo
  • Consistent benefits were also seen across both studies in all three key secondary endpoints, with significant reduction in frequency of VMS at week 1, improvement in sleep disturbances and menopause-related quality of life
  • The safety profile in both studies was favorable
  • These late-breaking data will be presented for the first time during a scientific symposium at the 2024 American College of Obstetricians and Gynecologists (ACOG) annual meeting

BERLIN–(BUSINESS WIRE)–Bayer will present detailed results from the pivotal Phase III studies OASIS 1 and 2, showing that the investigational compound elinzanetant significantly reduced frequency and severity of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause compared to placebo. In addition, elinzanetant met its key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improved sleep disturbances and menopause related quality of life compared to placebo. These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting taking place from May 17 – 19 in San Francisco, CA, USA.

Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to week 4 and 12 compared to placebo. Elinzanetant showed in OASIS 1 significant mean reductions versus placebo for frequency at week 4 with -3.29 (p<0.0001) and week 12 with -3.22 (p<0.0001) and for severity at week 4 with -0.33 (p<0.0001) and week 12 with -0.40 (p<0.0001). In OASIS 2, elinzanetant demonstrated significant mean reductions versus placebo for frequency at week 4 with -3.04 (p<0.0001) and at week 12 with -3.24 (p<0.0001) and for severity at week 4 with -0.22 (p=0.0003) and at week 12 with -0.29 (p<0.0001). The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups.

“There are limited approved non-hormonal treatments for bothersome menopausal symptoms, such as hot flashes and sleep disturbances. Consequently, many women experience discomfort for months or even years, with the majority of symptoms left untreated,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health. “These results are exciting news for women who suffer from moderate to severe hot flashes and build on our confidence that elinzanetant may be a potential non-hormonal solution for them.”

Both studies also achieved for all three key secondary endpoints a statistically significant reduction in the frequency of VMS from baseline to week 1 (p<0.0001 and p=0.0013, respectively), as well as statistically significant improvements in sleep disturbances (p<0.0001 in both studies) and menopause-related quality of life (p<0.0001 and p=0.0059, respectively) compared to placebo.

“The robust efficacy and favorable safety profile of elinzanetant reinforces its potential as a non-hormonal treatment for women experiencing menopause,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We look forward to submitting applications to health authorities for marketing authorizations of elinzanetant to treat moderate to severe VMS associated with menopause, building upon our extensive legacy and commitment to women’s healthcare.”

Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

Earlier in March 2024, Bayer announced positive topline results for the third Phase III study OASIS 3 in the OASIS clinical development program evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo. In this study, elinzanetant successfully met the primary endpoint demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo. The long-term safety profile observed over 52 weeks in the OASIS 3 study is overall consistent with previously conducted studies and published data1,2 on elinzanetant. These results will be presented at upcoming scientific congresses.

Bayer will submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause.

About the OASIS 1, 2 and 3 studies

OASIS 1 and 2 (NCT05042362 and NCT05099159) are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 (NCT05030584) is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. OASIS 3 randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

About the Elinzanetant clinical development program

The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.

In addition to the OASIS program, Bayer started NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant

Elinzanetant is the first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

kw (2024-0066E)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1 Simon, JA; Anderson, RA; Ballantyne, E, et al. (2023). Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause; 30 (3): 239–246. 26 2 Trower, M; Anderson, RA; Ballantyne, E, et al. (2020). Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause; 27 (5): 498–505.

Contacts

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Lifecore Biomedical Completes Incremental Liquidity Initiatives

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Lifecore Biomedical Completes Incremental Liquidity Initiatives




Lifecore Biomedical Completes Incremental Liquidity Initiatives

Recent Initiatives Provide Approximately $8 Million of Non-Dilutive, Incremental Liquidity through Various Amendments with Lenders

CHASKA, Minn., May 16, 2024 (GLOBE NEWSWIRE) — Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore” or the “Company”), a fully integrated contract development and manufacturing organization (“CDMO”), announced certain incremental liquidity measures and housekeeping matters related to divested businesses through a series of 8-K filings over the past week.

James G. Hall, President and Chief Executive Officer of Lifecore, commented, “We believe these incremental liquidity improvements will provide Lifecore with additional financial resources to continue to achieve its business objectives. During fiscal year 2024, and with the approximately $8 million of incremental liquidity improvements recently announced, we have now added up to approximately $18.5 million in non-dilutive incremental liquidity. We are excited about working with our new independent auditor, BDO, as we seek to get current on our public filings as promptly as possible, and successfully closing out our fiscal year at the end of May.”

Lender Updates
On May 2, 2024, the Company entered into an amendment related to its contract manufacturing agreement with its term lender and customer, in which the lender made a prepayment in the amount of $5.5 million in cash as an advance on future purchases. Under the terms, the lender is entitled to apply the prepayment towards invoices issued by the Company within the scope of the agreement during calendar year 2026.

On May 10, 2024, the Company also entered into the Seventh Amendment to the ABL Loan Agreement with its ABL lender to execute a “first-in, last-out” tranche of revolving loans under the ABL Loan Agreement (the “FILO Amendment”). While not increasing the overall revolver commitment of $40 million, the FILO Amendment provides for up to approximately $2.5 million of incremental revolving loan capacity to the Company, subject to a variable cap, without changing the collateral. In connection with the FILO Amendment, the margin rate applicable to the borrowings pursuant to the FILO Amendment was increased to SOFR plus 4.25%, which is expected to increase annual cash interest expense by approximately $44,000 assuming $2.5 million in FILO tranche borrowings thereunder. The maximum capacity of permitted borrowings pursuant to the FILO Amendment will be reduced on a monthly basis commencing October 1, 2025.

Subsidiary Assignment for the Benefit of Creditors
On May 15, 2024, the Company entered into an assignment for the benefits of creditors related to the remaining assets and liabilities of its wholly owned subsidiary, Curation Foods, Inc, to facilitate the finalization of the winding down of that entity. Pursuant to the terms of the assignment, the assignee will seek to monetize any remaining assets of Curation Foods, Inc., and settle any remaining liabilities of that entity.

Liquidity Update
As of April 21, 2024, the end of the Company’s period 11 fiscal month, the Company’s total term and ABL revolver debt (excluding debt discount and issuance costs) and cash was $178.9 million and $3.0 million, respectively, compared to the previously reported $180.7 million and $3.2 million, respectively, for the fiscal 2024 third quarter ended February 25, 2024. Giving effect to the incremental liquidity increases announced today, on a pro forma basis, total debt and cash as of April 21, 2024 would have been $178.9 million and $11.0 million, respectively.

Incentive Plan Amendment
On May 1, 2024, the Compensation Committee and the Board approved an amendment to the Company’s 2024 Annual Incentive Plan as it relates to James G. Hall and John D. Morberg, the Company’s executive officers. Under the terms of the amendment, any cash incentive amount that would have been earned by Mr. Hall and Mr. Morberg under the 2024 Annual Incentive Plan will be paid in fully vested, unrestricted shares of common stock of the Company.

About Lifecore Biomedical
Lifecore Biomedical, Inc. is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of complex sterile injectable pharmaceutical products in syringes and vials. As a leading manufacturer of premium, injectable grade Hyaluronic Acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the Company, visit Lifecore’s website at www.lifecore.com.

Important Cautions Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our preliminary estimates of historical financial data for the Historical Periods, current operating and financial expectations in light of historical results, anticipated capacity and utilization, anticipated liquidity, and anticipated future customer relationships usage are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the Company’s results from operations and ability to maintain its borrowing capacity, the competition of the Company’s financial closing procedures, the Company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, the Company’s ability to become current with its reports with the Securities and Exchange Commission (the “SEC”), and the timing thereof, the Company’s ability to regain compliance with applicable listing standards under Nasdaq, and its ability expand its relationship with its existing customers or attract new customers, the impact of inflation on the Company’s business and financial condition, indications of a change in the market cycles in the CDMO market; changes in business conditions and general economic conditions both domestically and globally including rising interest rates and fluctuation in foreign currency exchange rates, access to capital; and other risk factors set forth from time to time in the Company’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 28, 2023 (the “2023 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2023 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

Lifecore Biomedical, Inc. Contact Information:
Jeff Sonnek
(646) 277-1263
jeff.sonnek@icrinc.com