Ibogaine By David Dardashti Begins Design on Algorithm for Quantum Electrodynamics

Ibogaine By David Dardashti Begins Design on Algorithm for Quantum Electrodynamics




Ibogaine By David Dardashti Begins Design on Algorithm for Quantum Electrodynamics

Ibogaine By David Dardashti Develops Algorithm for Quantum Electrodynamics to Optimize Treatment Times

MIAMI, March 19, 2024 (GLOBE NEWSWIRE) — Ibogaine By David Dardashti is proud to announce the development of a unique algorithm designed to predict the flow of quantum electrodynamics in discrete time intervals.

Ibogaine By David Dardashti has implemented the development of an algorithm that will help predict the current flow of quantum electrodynamics. This algorithm will be used to expedite the experiment in order to determine the most effective times to administer Ibogaine treatment. The primary components of the algorithm revolve around angular measurements involving the flow of electric currents in 11-dimensional hyperspace. It serves as a basic framework that will improve the accuracy of the current measurements being taken. One of the many components of the algorithm involves the use of Einstein’s predicament on energy based on photons. This can be interpreted through using trigonometric integrals altercating rotational inertia.

Additionally, higher-level dimensions of electric currents can be understood through applications of vector calculus applied to a power series of differentiating limits of the integral. These techniques are used to optimize angular velocity and flow of electric currents through higher levels involving rotational inertia of the earth, sun, and moon. The algorithm developed by Ibogaine By David Dardashti utilizes angular measurements to predict the flow of electric currents in 11-dimensional hyperspace and is used to expedite the effectiveness of their treatments.

Ibogaine By David Dardashti will be continuing to develop this algorithm with the hopes of providing a much more in-depth understanding of the flow of quantum electrodynamics and how it affects treatment times.

IMG_3075
Modern Quantum Electrodynamics Current trends used to help optimize electric currents and the impact they have on brain development. 

Contact
Gavriel Dardashti
+17869301880
gavriel@ibogaineclinic.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3d04f3df-2d41-4ab1-883c-0dc23c74aa79

Medigene AG to participate in the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference

Medigene AG to participate in the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference




Medigene AG to participate in the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference

Planegg/Martinsried, March 19, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, will be participating in the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference on March 26, 2024.

Members of Medigene’s management team will join a fireside chat and will be available for virtual one-on-one meetings with registered investors.

—  end of press release  —

About Medigene AG
Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptor engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://medigene.com/

 Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
Email: investor@medigene.com

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JenaValve’s Trilogy THV System Highlighted at CRT 2024

JenaValve’s Trilogy THV System Highlighted at CRT 2024




JenaValve’s Trilogy THV System Highlighted at CRT 2024

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024. JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.

The clinical value of the Trilogy valve was illustrated by Dr. Luca Testa, Head of the Coronary Revascularization Unit and Clinical Research Unit at IRCCS San Donato Hospital, Milan, during a session titled Performance of Purpose-Built Versus Off-Label Transcatheter Devices for the Treatment of Aortic Regurgitation: The Purpose Study. This session reviewed an observational study examining outcomes of patients with ssAR treated with off-label THV’s versus a device designed to treat ssAR. Results showed significantly better technical and device success in the Trilogy arm, with significantly less valve embolization, need for a second valve, and post-procedural aortic regurgitation.

Dr. Testa stated, “The results of the PURPOSE study, the first comparison of off-label THVs versus a dedicated device, such as the JenaValve Trilogy THV, showed that the Trilogy represents a better option for inoperable patients with ssAR, in terms of both procedural and device success, according to the VARC-3 definitions.”

“We are encouraged by the sheer number of presentations and conversations surrounding ssAR. We know that there is a significant unmet need for patients with this disease and are pleased to see greater recognition of the importance of dedicated treatment options,” said John Kilcoyne, Chief Executive Officer of JenaValve. “This substantial clinical focus is further validation of the work we are doing and the expansive market opportunity ahead of us.”

About JenaValve
JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.

JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Additional information is available at www.jenavalve.com.

Investor Relations Contact:
Marissa Bych
marissa@gilmartinir.com

Clover Health Launches New Clinical Program in Partnership with Quartet Health to Address Serious Mental Illness

Clover Health Launches New Clinical Program in Partnership with Quartet Health to Address Serious Mental Illness




Clover Health Launches New Clinical Program in Partnership with Quartet Health to Address Serious Mental Illness

Partnership aims to improve outcomes through increased support to underserved and at-risk patient populations through Clover’s home-based care model

FRANKLIN, Tenn., March 19, 2024 (GLOBE NEWSWIRE) — Today, Clover Health (“Clover” or the “Company”) announced a partnership with Quartet Health, a value-based behavioral health care enablement and delivery company, to increase the support and resources provided to Clover members with serious mental illness (SMI) through the Company’s home-based care delivery unit, Clover Home Care.

As part of this partnership, Quartet will use its expert care teams to augment Clover Home Care’s capabilities. Quartet’s clinicians will also begin using the Clover Assistant platform to deliver care to the Clover patients under its care.

Clover Home Care addresses the needs of Clover’s most complex patient cohorts by delivering in-home care access, medication support, mental and physical care coordination, as well as local community resource and transportation support. Its care teams – both in-home and virtual – are led by physicians and nurse practitioners trained in both palliative care and family medicine, along with care coordinators, social workers, medical assistants and dedicated case managers.

To augment Clover Home Care’s robust care delivery model, and address one of Clover’s highest need cohorts, the Company is tapping into the behavioral health expertise of Quartet Health’s Whole Health program to provide additional support to members suffering from SMI. The Whole Health program is a unique, whole-person care delivery solution that delivers a fully-integrated physical and behavioral health model that will take accountability for the total cost of care (TCOC) on Clover Health’s most complex members, while also providing wraparound care services for a traditionally underserved patient population.

“Patients with serious mental illness often have worse outcomes and a lower life expectancy, and they experience a fragmented healthcare system that does not adequately address their behavioral, physical, and social needs,” said Dr. Michael J. Lipp, Quartet Health’s Chief Medical Officer, and former CMO of the CMS Innovation Center. “Patients often struggle to get access to care, and the care they do receive is often uncoordinated. Layered on top of Clover Assistant’s data-driven insights, this program will provide care that is coordinated, comprehensive and convenient, at no additional cost to patients.”

“Through Clover Home Care, we are delivering impactful, proactive support to our members via a high-touch model built on top of the computing power of Clover Assistant. This allows our highly skilled and compassionate care teams to have a holistic view of each patient’s individual needs and address them accordingly,” said Brady Priest, CEO of Clover Home Care. “We’re confident that additional behavioral health support for our SMI cohort will increase the quality of life for these members, while continuing to reduce unnecessary spend.”

In addition to its care management capabilities, Clover’s proprietary technology stack is essential in driving enrollment in disease-specific programs like Whole Health by Quartet. For example, Artificial intelligence (AI) embedded in Clover Assistant will identify members at highest risk of suffering from under-treated SMI, and identify increasing risk of hospitalizations for the SMI population.

As of January 1, Clover Home Care with Whole Health by Quartet Health is available to eligible members in New Jersey for no additional cost. For Clover members interested in learning more about the program, including eligibility, visit https://www.quartethealth.com/whole-health or call 888-528-7618.

About Clover Health
Clover Health (Nasdaq: CLOV) is a physician enablement company committed to bringing access to great healthcare to everyone on Medicare. This includes a health equity-based focus on seniors who have historically lacked access to affordable, high-quality healthcare. Our strategy is powered by our software platform, Clover Assistant, which is designed to aggregate patient data from across the healthcare ecosystem to support clinical decision-making and improve health outcomes through the early identification and management of chronic disease.

About Quartet Health
Quartet is a leading value-based behavioral health care enablement and delivery company. Our goal is to improve lives through quality, whole-person care for those with behavioral healthcare needs. Quartet is a trusted partner of health plans, health systems, and community mental health centers in 40 states across the country. We identify people in need of care and connect them directly to high-quality providers, including Quartet’s own medical group.

Forward-Looking Statements

Please note that this press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements regarding future events and Clover’s future results of operations, financial position, business strategy and future plans. Forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on such statements. In some cases, you can identify forward looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “going to,” “can,” “could,” “should,” “would,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “outlook,” “forecast,” “guidance,” “objective,” “plan,” “seek,” “grow,” “target,” “if,” “continue” or the negative of these words or other similar terms or expressions that concern Clover Health’s expectations, strategy, priorities, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding expectations related to the Company’s Home Care business and the Company’s profitability, liquidity, future performance, future operations and future results. These statements are subject to known and unknown risks, uncertainties and other factors that may cause Clover’s actual results, levels of activity, performance or achievements to differ materially from results expressed or implied in this report. Additional information concerning these and other risk factors is contained in Clover’s most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2024 and as may be updated in the Company’s subsequent filings with the SEC. The forward-looking statements included in this press release are made as of the date hereof. Except as required by law, Clover undertakes no obligation to update any of these forward-looking statements after the date of this press release or to conform these statements to actual results or revised expectations.

Investor Relations Contact:
Ryan Schmidt
investors@cloverhealth.com

LiveCare Inc. (OTCMKTS: LVCE) Experiences Unprecedented Growth and Technological Advancements Post-Revamp

LiveCare Inc. (OTCMKTS: LVCE) Experiences Unprecedented Growth and Technological Advancements Post-Revamp




LiveCare Inc. (OTCMKTS: LVCE) Experiences Unprecedented Growth and Technological Advancements Post-Revamp

Venice, FL, USA, March 19, 2024 (GLOBE NEWSWIRE) — LiveCare Inc. (OTCMKTS: LVCE), a pioneering force in the Telehealth sector, announces remarkable strides in patient acquisition and recurring monthly revenue growth, marking a significant milestone since the company’s strategic overhaul in 2023. This transformation has not only bolstered LiveCare Inc.’s position in the Telehealth industry but also underscored its commitment to helping people and saving lives while enhancing patient care through innovative technology and its 24/7 live monitoring.

Since the revamp, LiveCare Inc. has experienced a surge in patient engagement, with an impressive 2,500 new patients, since starting its own in-house sales initiative. These patients are entrusting their chronic healthcare needs to LiveCare’s cutting-edge program with 24/7 access to live, caring professionals. This increase in patient acquisition reflects the company’s unwavering dedication to accessibility, efficiency, and quality care as evidenced by growing patient membership from around 2,600 in October 2023, to approximately 5,100 patients today.

In addition to patient growth, LiveCare Inc. has reported a substantial increase in recurring monthly revenue, expected at over $500,000 this month versus $313,000 for December 2023’s billing showing 166% increase in three short months. This financial achievement is a testament to the company’s successful business model and its transition to becoming cash flow positive and profitable expected soon. LiveCare Inc. is setting new standards in the Telehealth industry, demonstrating that it is on a clear path to becoming a leading name in healthcare innovation.

“Since our strategic revamp in October 2023, LiveCare Inc. has been on an upward trajectory, helping people, saving the lives of loved ones and continually enhancing our technology to meet the evolving needs of our patients,” stated Max Rockwell, CEO of LiveCare Inc. “Our growth in patient acquisition and recurring revenue not only highlights our drive for financial stability but also our potential to revolutionize Telehealth delivery. We are setting the record straight – LiveCare Inc. is not just a company, but a beacon of hope for the future of Telehealth.”

The success of LiveCare Inc. can be attributed to its relentless pursuit of technological innovation and patient-centric care around its 24/7 live monitoring. The company’s proprietary technology has been instrumental in streamlining Telehealth processes, enabling real-time patient monitoring, and providing immediate access to medical professionals. This has significantly improved patient outcomes and satisfaction, reinforcing LiveCare’s mission to make healthcare accessible and efficient for everyone.

Looking ahead, LiveCare Inc. remains committed to its mission of helping its patients, saving lives and is poised for continued growth. With a solid foundation of technological advancements, a robust business model, and a clear vision for the future, LiveCare Inc. is on its way to achieving unprecedented success in the Telehealth landscape.

About LiveCare Inc.

LiveCare Inc. (OTCMKTS: LVCE) is a leading Telehealth company dedicated to transforming patient care through innovative technology and personalized 24/7 support. With a focus on accessibility, efficiency, and quality care, LiveCare Inc. provides a comprehensive platform for real-time patient monitoring, immediate access to healthcare professionals, and personalized healthcare solutions. Committed to saving lives and improving patient outcomes, LiveCare Inc. is setting new standards in healthcare delivery.

For more information about LiveCare Inc., please visit:
https://www.LiveCarehealth.com/investors

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate”, “Projection”, or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict and many of which are beyond the control of LiveCare Inc. Actual results may differ from those projected in the forward-looking statements due to risks and uncertainties, as well as other risk factors that are included in the Company’s filings with the U.S. Securities and Exchange Commission. Although LiveCare Inc believes that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the results contemplated in forward-looking statements will be realized. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by LiveCare Inc or any other person that their objectives or plans will be achieved. LiveCare Inc does not undertake any obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact Information:
LIVECARE Phone: (800) 345-0491
LiveCare Website: https://www.LiveCarehealth.com/investors

Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant

Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant




Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant

  • OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive topline results of OASIS 1 and 2 studies
  • Bayer will submit data from OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
  • 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

BERLIN–(BUSINESS WIRE)–Bayer today announced positive topline results of the Phase III study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo. In this study, elinzanetant successfully met the primary endpoint demonstrating 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.


“OASIS 3 was designed to address the important question of the long-term profile of elinzanetant. With the positive topline results of OASIS 3 adding to the existing evidence from OASIS 1 and 2, elinzanetant has consistently shown positive data across all Phase III clinical trials in the treatment of moderate to severe VMS associated with menopause,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We are looking forward to sharing the full data at upcoming medical conferences as we move towards submitting to health authorities.”

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.

“It is critical that we continue to broaden therapeutic options that will effectively meet the significant needs of menopausal women,” said Nick Panay, Principal Investigator for OASIS 3, Consultant Gynaecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and President of International Menopause Society. “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms.”

OASIS 3 (NCT05030584) is the third Phase III study in the OASIS clinical development program with positive topline results. In early 2024, Bayer announced topline data of the first two Phase III studies OASIS 1 and 2 (NCT05042362 and NCT05099159) which met all primary and key secondary endpoints. The results of all three studies 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 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. OASIS 3 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 OASIS 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.

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 world population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million new women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function, and which usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, for example 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 and 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

Follow us on Twitter: @BayerPharma

kw (2024-0048e)

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, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.

2 Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 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

Mainz Biomed Organizes HALLO DOC! Event to Highlight Innovations in Colorectal Cancer Treatment

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

19.03.2024 / 13:01 CET/CEST

The issuer is solely responsible for the content of this announcement.

Mainz Biomed Organizes HALLO DOC! Event to Highlight Innovations in Colorectal Cancer Treatment

BERKELEY, US – MAINZ, Germany – March 19th 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, will be organizing the HALLO DOC! event, informing about colorectal cancer, cutting-edge research, new treatment modalities and holistic therapeutic approaches. This event will take place on March 20, 2024, in Berlin, Germany, aligning with the Colorectal Cancer Awareness Month.

HALLO DOC! comes at a critical time as the incidence of colorectal cancer increases alarmingly, particularly among the youth, emphasizing the necessity for effective prevention, early detection, and the avoidance of recurrence. Mainz Biomed has organized this event to shed light on new diagnostic methods, the importance of a comprehensive treatment approach, and the latest advancements in colorectal cancer research.

Event Highlights:

  • Expert Insights: Keynote presentations by renowned experts, including Prof. Dr. Guido Schumacher, Priv. Doz. Dr. med Annika Kurreck, Prof. Dr. Ingo Froböse, and Priv. Doz. Dr. Severin Daum, offering invaluable insights into modern colorectal cancer treatment methods, the critical role of early detection, and personalized medicine.
  • Patient Perspective: A moving account by Jule Blöhmer, a young colorectal cancer survivor, aiming to inspire and inform others about the journey through diagnosis, treatment, and recovery.
  • Interactive Sessions: Engaging Q&A sessions with the audience, both on-site and streaming online, facilitating a deeper understanding and discussion about colorectal cancer.
  • Innovative Research: Presentation of groundbreaking studies on the role of the microbiome and molecular markers in colorectal cancer prevention and treatment, highlighting Mainz Biomed’s contributions to the field.
  • Networking Opportunity: A “Get Together” session to conclude the event, allowing for personal interactions among attendees, speakers, and professionals.

Attendance:

  • Time & Date: March 20, 2024, from 05:00 pm to 08:00 pm (CET)
  • Location: bUM Berlin, Germany

Mainz Biomed is at the forefront of developing market-ready, molecular-genetic diagnostic solutions for life-threatening conditions. Its flagship product, ColoAlert®, offers an accurate, non-invasive, and easy-to-use at-home screening test for colorectal cancer, marking a significant advancement in early detection and prevention strategies.

Guido Baechler, Chief Executive Officer of Mainz Biomed, commented, “As we witness a disturbing trend over the past two decades – a rise in colorectal cancer cases among younger populations – it’s imperative to focus on innovative solutions and holistic approaches to combat this disease. The HALLO DOC! event represents our commitment to advancing the dialogue on prevention, early detection, and treatment, featuring insights from some of the most esteemed professionals in the field.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About ColoAlert®

ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed N.V.  

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.   

For media inquiries

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu  

In the U.S.:
Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


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Rapport Therapeutics Appoints Pioneering Industry Leader John Maraganore to Board of Directors

Rapport Therapeutics Appoints Pioneering Industry Leader John Maraganore to Board of Directors




Rapport Therapeutics Appoints Pioneering Industry Leader John Maraganore to Board of Directors

BOSTON & SAN DIEGO–(BUSINESS WIRE)–Rapport Therapeutics, Inc., a clinical-stage biotechnology company leveraging the science of receptor-associated proteins (RAPs) to advance precision neuromedicines, today announced the appointment of John Maraganore, Ph.D., to its Board of Directors. Dr. Maraganore, former founding Chief Executive Officer of Alnylam Pharmaceuticals, Inc. (Alnylam), currently serves as Venture Partner at both ARCH Venture Partners and Atlas Ventures, as Senior Advisor at Blackstone Life Sciences, and as Principal and Chief Executive Officer at JMM Innovations, LLC.




As Rapport sets out to build a leading precision neuroscience company, we are incredibly fortunate to have Dr. Maraganore join our board,” said Abraham Ceesay, Chief Executive Officer of Rapport. “John is among a few visionary leaders who have guided a new modality from concept to a dynamic platform for drug discovery. He has been a driving force for innovation within our industry, and we believe his leadership will be indispensable as we work to advance our pipeline and potentially deliver much-needed new treatment options to patients with neurological disorders.”

I am thrilled to once again work alongside John to help Rapport realize its vision to become a preeminent precision neuroscience company. John has an impressive track record of building great science-based companies. His wisdom and experience will be invaluable as we advance our pipeline of precision neuroscience product candidates to positively impact the lives of those affected by debilitating neurological conditions,” said Steve Paul M.D., Chairman of the Rapport Board of Directors and Venture Partner at Third Rock Ventures.

Dr. Maraganore served as founding CEO of Alnylam from 2002 to 2021, where he led the development of a novel class of medicines, referred to as RNAi therapeutics. Under his leadership, Alnylam built over $25 billion in market capitalization, established more than 20 major pharmaceutical alliances and saw the approval and commercialization of four of its RNAi medicines, ONPATTRO®, GIVLAARI®, OXLUMO®, and Leqvio®. Prior to founding Alnylam, Dr. Maraganore held leadership positions at Millennium Pharmaceuticals, Inc. and Biogen, Inc. He also previously served as Chair of the Biotechnology Innovation Organization. Dr. Maraganore received his B.A. in biological sciences and M.S. and Ph.D. in biochemistry and molecular biology from the University of Chicago.

There’s a significant need and opportunity for new approaches in the treatment of neurological disorders, and Rapport has the potential to revolutionize care with its transformational science,” said Dr. Maraganore. “I’m honored to work with a team of such talented and accomplished individuals in these exciting times for both the company and the field at large.”

About Rapport (www.rapportrx.com)

Rapport is developing a new class of precision neuromedicines aimed at providing patients with better alternatives to existing treatments for central nervous system disorders. Current options often come with debilitating and intolerable side effects, leading to suboptimal dosing and noncompliance that limit drug efficacy and can result in discontinuation. The company’s platform, built and refined over the past decade by its founding scientific team, is designed to achieve precision through the discovery and targeting of receptor-associated proteins, or RAPs, which display regional or neural circuit-specific expression. By more precisely targeting the diseased brain regions, Rapport believes its platform has the potential to improve tolerability and clinical benefit. Rapport has ongoing clinical trials in epilepsy and discovery-stage programs in neuropathic pain, hearing disorders and bipolar disorder.

Contacts

Media:

Kit Rodophele

Ten Bridge Communications

617-999-9620

krodophele@tenbridgecommunications.com

PicnicHealth Appoints Rachael Thomas Higgins as Chief Commercial Officer

PicnicHealth Appoints Rachael Thomas Higgins as Chief Commercial Officer




PicnicHealth Appoints Rachael Thomas Higgins as Chief Commercial Officer

Higgins brings over 20 years of commercial experience in the life science industry

SAN FRANCISCO–(BUSINESS WIRE)–PicnicHealth, a company dedicated to simplifying observational research, today announced the appointment of Rachael Thomas Higgins as Chief Commercial Officer. Higgins joins the PicnicHealth leadership team to oversee commercial strategy, sales, and marketing.




“Rachael brings invaluable experience in business development and go-to-market strategy at a critical time in our company’s development,” said Noga Leviner, CEO and co-founder of PicnicHealth. “Her solution-driven mindset and proven track record in this space will be fundamental to expand the reach of our offering in 2024 and beyond.”

Higgins brings over 20 years of commercial expertise to PicnicHealth, most recently serving as Vice President of Commercial Sales at CorEvitas through its acquisition by Thermo Fisher Scientific. Prior to that, she has held leadership roles at Circuit Clinical, TriNetX, and Covance. In these roles, she has successfully defined go-to-market strategy and driven growth for life science solutions. Higgins holds a Bachelor of Science degree from Keene State College.

“PicnicHealth sits at the intersection of technology, scientific expertise, and innovation, revolutionizing how research is conducted,” says Rachael Thomas Higgins, Chief Commercial Officer at PicnicHealth. “I am thrilled to be part of a company that is redefining traditional ways of running trials without compromising data quality and completeness.”

About PicnicHealth

PicnicHealth delivers on the future of evidence generation by putting patients at the heart of research. Through direct patient engagement and scientific expertise, PicnicHealth collects and curates comprehensive clinical data and patient-reported outcomes across the patient journey to generate uniquely robust insights. To learn more about why 12 of the top 20 life science companies partner with PicnicHealth or to view our 35+ publications, visit picnichealth.com.

Contacts

media@picnichealth.com

Engrail Therapeutics Closes Oversubscribed $157M Series B Financing Round to Advance the Development of Transformational Therapies

Engrail Therapeutics Closes Oversubscribed $157M Series B Financing Round to Advance the Development of Transformational Therapies




Engrail Therapeutics Closes Oversubscribed $157M Series B Financing Round to Advance the Development of Transformational Therapies

Proceeds to Support Advancement of Engrail’s Pipeline for Neuropsychiatric and Neurodevelopmental Disorders

SAN DIEGO–(BUSINESS WIRE)–Engrail Therapeutics™ (Engrail) (the Company), a precision neuroscience company focused on the development of transformational therapies to improve the lives of patients, today announced the close of an oversubscribed $157 million Series B financing round. The round was co-led by new investors F-Prime Capital, Forbion, and Norwest Venture Partners, with participation from RiverVest Venture Partners, Red Tree Venture Capital, funds managed by abrdn Inc., Ysios Capital, Longwood Fund, Eight Roads Ventures, and existing founding investor Pivotal Life Sciences. Since its inception in 2019, the Company has raised over $220 million.


Funding from the Series B round will propel the advancement of the Company’s pipeline through multiple stages of clinical development. The Company is developing therapies for the treatment of diseases with significant unmet medical need including anxiety disorders, depression, posttraumatic stress disorder, and rare neurodegenerative diseases.

“With strong financial backing from highly sophisticated and dedicated life science investors, we are well positioned to deliver multiple value-creating milestones. Notably, we look forward to completing our ongoing ENX-102 phase 2 study in generalized anxiety disorder and advancing the rest of our pipeline into clinical development,” said Vikram Sudarsan, Ph.D., president and CEO of Engrail Therapeutics. “Engrail was fortunate to have been incubated under a tremendous commitment from Pivotal Life Sciences. We are excited to start the next chapter of our journey with some of the best thought partners in neuroscience and life sciences investing in our success.”

Following this financing, Stacie Weninger, Ph.D. (F-Prime), Jasper Bos, Ph.D. (Forbion), Tiba Aynechi, Ph.D. (Norwest), Niall O’Donnell, Ph.D. (RiverVest), and Heath Lukatch, Ph.D. (Red Tree) have joined the Engrail board of directors.

“We see tremendous potential in Engrail’s pipeline and management team and are excited to participate in their development of transformative therapies for patients,” said Stacie Weninger, Ph.D., board member and president of F-Prime Biomedical Research Initiative.

Peter Bisgaard, chairman of Engrail’s board of directors and managing director at Pivotal Life Sciences added, “We are proud to have started Engrail, which has progressed rapidly from an idea into a clinical-stage neuroscience company within just a few years. We have assembled a strong Series B syndicate that positions the organization well for significant growth and pipeline advancement.”

About Engrail Therapeutics

Engrail is a clinical-stage pharmaceutical company with the aspiration of becoming a leader in neuroscience. Our purpose is to deliver transformational therapies that improve the lives of patients with neuropsychiatric and neurodevelopmental diseases.

For more information, visit engrail.com.

Contacts

Anil Vootkur, PharmD

Engrail Therapeutics

anil@engrail.com