Vistagen Announces Positive Results from Phase 2A Pilot Study of PH15 for Improvement of Psychomotor Impairment Caused by Mental Fatigue




Vistagen Announces Positive Results from Phase 2A Pilot Study of PH15 for Improvement of Psychomotor Impairment Caused by Mental Fatigue

PH15 nasal spray demonstrates statistically significant efficacy versus placebo and caffeine in a placebo-controlled Phase 2A pilot study in sleep-deprived participants

PH15 was safe and well-tolerated with an adverse event profile similar to placebo

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$VTGN #mentalhealth—Vistagen (Nasdaq: VTGN), a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced positive results from a Phase 2A pilot study of PH15, an investigational pherine nasal spray, for improvement of psychomotor impairment caused by mental fatigue. PH15 demonstrated a statistically significant improvement in reaction time compared to placebo and caffeine in sleep-deprived study participants.

The previously unreported randomized, double-blind, placebo-controlled, crossover Phase 2A pilot study of PH15 was designed to explore the efficacy, safety, and tolerability of intranasal administration of PH15 on psychomotor performance as measured by reaction time in sleep-deprived participants. Ten participants were randomly administered PH15 (multiple 1.6 µg doses, total dose of 9.6 µg), placebo (nasal spray and oral), or caffeine (single 400 mg oral dose administered 1 hour before the session) in sequential sleep deprivation study sessions spaced one week apart. During each sleep deprivation session, participants received blinded treatments before the start of each of four testing periods, at 6:00 p.m., 9:00 p.m., midnight, and 3:00 a.m. The participants’ reaction times to both isochronous (regular interval) and stochastic (random interval) “flash” light stimuli were computer-measured during each testing period as participants responded to the luminous stimuli.

Statistically Significant Efficacy

During both isochronous and stochastic reaction time tests, administration of 1.6 µg PH15 nasal spray induced a significantly faster mean reaction time compared to placebo nasal spray across all time points (p<0.001). PH15 also demonstrated a statistically significant improvement in reaction time compared to oral caffeine (p<0.001) for both reaction time tests during the testing periods at midnight and 3:00 a.m. when subjects were most fatigued.

Well-tolerated Therapy

PH15 was well-tolerated with no serious adverse events reported. The adverse event profiles of PH15 and placebo were comparable, with brief nasal itching in one PH15-dosed participant and three placebo-dosed subjects. Participants on oral caffeine, however, experienced palpitations, euphoria, dry mouth, stomachache, and polyuria.

“In this Phase 2A pilot study, PH15 nasal spray demonstrated significant improvement in reaction time when compared to both oral caffeine and placebo in sleep-deprived participants. These pilot findings contribute to our confidence in PH15’s potential as an innovative treatment for enhancing psychomotor performance and potentially cognitive impairment, particularly in addressing the challenges of mental fatigue,” said Shawn Singh, Chief Executive Officer of Vistagen. “Numerous disorders, such as shift work disorder, sleep apnea, and narcolepsy, can lead to debilitating sleep deprivation and mental fatigue. Individuals affected by these disorders require improved treatment options with a differentiated safety profile, one without the potential for abuse liability or negative and treatment-limiting side effects and safety concerns. We anticipate exploring PH15’s potential to emerge as a new and transformative solution for these underserved individuals.”

This previously unreported Phase 2A pilot study of PH15 was sponsored by Pherin Pharmaceuticals (Pherin), now a wholly owned subsidiary of Vistagen, and conducted at the National Institute of Psychiatry, Sleep Disorders Clinic in Mexico City, Mexico in 2011. Vistagen gained access to the results of this study in connection with its acquisition of Pherin in February 2023. The late Jose Maria Calvo, MD, formerly Associate Professor, National Institute of Psychiatry in Mexico City, served as the Principal Investigator of the study.

About Pherines

Pherines are novel neurocircuitry-focused drug candidates delivered intranasally for treatment of psychiatric and neurological disorders. The proposed mechanisms of action (MOAs) of pherines are fundamentally differentiated from the MOAs of all approved drugs, offering a new standard of care for multiple central nervous system (CNS) disorders. Their effect on the CNS is through the activation of nasal chemosensory receptors, which send signals through neural circuitry to specific brain regions. The novel nose-to-brain MOAs of pherines offer the potential to deliver meaningful, rapid-onset efficacy and a differentiated safety profile, without systemic absorption or CNS uptake. All of the five pherines in Vistagen’s clinical-stage neuroscience pipeline have demonstrated a favorable safety profile in clinical trials completed to date.

About PH15

PH15 is an odorless, tasteless synthetic investigational pherine with a novel, rapid-onset proposed mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments to improve psychomotor or cognitive impairment caused by mental fatigue. PH15’s proposed MOA targets nasal receptors that activate olfactory-amygdala and olfactory hippocampus neural circuits in the limbic system that are known to be associated with psychomotor activity and cognition, without requiring systemic absorption or direct action on neurons in the brain. PH15 has demonstrated an excellent safety profile in all clinical trials completed to date. Vistagen is currently evaluating the potential Phase 2 development path forward for PH15 and a nonclinical program required to support a U.S. Investigational New Drug application to facilitate further Phase 2 development of PH15 in the U.S.

About Vistagen

Vistagen (Nasdaq: VTGN) is a biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders. Five of Vistagen’s clinical-stage neuroscience pipeline candidates belong to a new class of drugs known as pherines, which are investigational neuroactive nasal sprays with innovative proposed mechanisms of action that activate chemosensory neurons in the nasal passages to impact fundamental neural circuitry in the brain without the need for systemic absorption or binding to receptors in the brain. Vistagen’s sixth investigational candidate is an oral prodrug with potential to modulate NMDA receptor activity. At Vistagen, we are passionate about delivering differentiated treatments that set new standards of care for people living with anxiety, depression, and other neurological disorders. Connect at www.Vistagen.com.

Forward-looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or development may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that any of the Company’s drug candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful, or that the Company will be able to successfully replicate the result of past studies of any of its product candidates, including PH15. Other factors that may cause such a difference include, without limitation, risks and uncertainties related to delays in launching, conducting and/or completing nonclinical programs for any of the Company’s drug candidates, including PH15; launching, conducting and/or completing ongoing and future clinical trials for any of the Company’s drug candidates; the scope and enforceability of the Company’s patents; the Company’s ability to secure adequate financing for clinical development of certain of its drug candidates; fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or future clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s drug candidates. These risks are more fully discussed in the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2023, and in the Company’s most recent Quarterly Report on Form 10-Q for the quarter ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). The Company’s SEC filings are available on the SEC’s website at www.sec.gov. Additionally, you should not place undue reliance on these forward-looking statements in the future, because they apply only as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Contacts

Investors:

Mark McPartland

(650) 577-3606

markmcp@vistagen.com

Media:

Caren Scannell

(650) 577-3601

cscannell@vistagen.com

Immunome Appoints Sandra M. Swain to Board of Directors




Immunome Appoints Sandra M. Swain to Board of Directors

BOTHELL, Wash.–(BUSINESS WIRE)–Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced the appointment of Sandra M. Swain, M.D., to its Board of Directors. Dr. Swain has over 30 years of oncology clinical research experience and has served on both public company and non-profit boards.

“Immunome is pleased to welcome Sandra to the Board of Directors, especially given her extensive experience as a successful clinical researcher,” stated Clay Siegall, PhD, President and Chief Executive Officer of Immunome. “Her deep understanding of oncology and patient care will add a valuable perspective as we advance AL102 through Phase 3 and prepare Investigational New Drug (IND) filings for IM-1021 and IM-3050.”

“I am drawn to Immunome’s commitment to developing transformative therapies that meaningfully improve patients’ lives,” remarked Dr. Swain. “Immunome’s promising pipeline, talented team, and focus on patients offers a tremendous opportunity to address unmet medical need. I look forward to serving as a Board member and supporting Immunome’s important mission.”

Dr. Swain has served as Associate Dean for Research Development at Georgetown University Medical Center since 2016, and as Professor of Medicine at Georgetown University Medical Center since 2007. She has also served as Vice President of Genetic Medicine at MedStar Health, a not-for-profit healthcare system, since 2018. Dr. Swain served on the board of directors of the American Society of Clinical Oncology (ASCO) from 2008-2013 and was ASCO President 2012-13. Since 2007, Dr. Swain has served on the board of directors for Conquer Cancer, the ASCO Foundation, including as treasurer of the Executive Committee from 2016 to 2019 and on the Joint Investment Committee from 2016 to 2018. Dr. Swain previously served on the board of directors of Seagen Inc. from November 2022 until its acquisition by Pfizer Inc. in December 2023. Dr. Swain holds an M.D. from the University of Florida and a B.A. in Chemistry from the University of North Carolina at Chapel Hill. Dr. Swain completed a residency in Internal Medicine at Vanderbilt University and a fellowship in Medical Oncology at the National Cancer Institute, National Institutes of Health.

About Immunome, Inc.

Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, RLTs and immunotherapies. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

For more information, visit www.immunome.com or follow us on X/Twitter and LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “advance,” “promising,” “opportunity,” “look forward,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, statements regarding Immunome’s expectations regarding its ongoing clinical trial for AL102 and preparation of IND filings for IM-1021 and IM-3050; the advancement of Immunome’s pipeline; the ability to execute on Immunome’s mission; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors. These factors include, but are not limited to, the risk that Immunome will not be able to realize the benefits of its strategic transactions, Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, market, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that our product and development candidates fail to achieve their intended endpoints; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in exhibit 99.2 filed with Immunome’s Current Report on Form 8-K with Securities and Exchange Commission (“SEC”) on February 13, 2024, and in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 28, 2024, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.

Contacts

Max Rosett

Interim Chief Financial Officer

investors@immunome.com

Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis




Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

• Namilumab is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a pro-inflammatory cytokine believed to play a key role in the pathogenesis of sarcoidosis
• RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to be supportive of registration that enrolled 107 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatments
• Topline results are expected by the end of calendar year 2024

BASEL, Switzerland & LONDON & NEW YORK–(BUSINESS WIRE)–Roivant (Nasdaq: ROIV) and Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung). Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, an immune-mediated inflammatory disease that can affect any organ in the body, with about 90% of cases involving the lung. Namilumab is a potent anti-GM-CSF monoclonal antibody formulated to be conveniently administered once-monthly as a subcutaneous injection that has the potential to be the first disease-modifying therapy for sarcoidosis. Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options.

“People living with pulmonary sarcoidosis clearly need new therapeutic options that can more safely and effectively control or resolve their disease,” said Bill Gerhart, CEO of Kinevant. “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis. I am grateful for the patients who volunteered to participate in the study, as well as for the extraordinary efforts of the Kinevant team, our industry partners, clinical trial site staff, and patient advocacy groups, all of whom came together to overcome the unique challenges of this disease to successfully enroll this study. We are very hopeful about the outcome, and we look forward to reporting topline results by the end of the year.”

Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas (clumps of immune cells) of unknown etiology that can cause breathlessness, fatigue, and pain. The resulting inflammation, if not effectively treated, can result in lung tissue scarring (fibrosis), lung dysfunction, and eventually lung failure. Approximately 50% of diagnosed patients require chronic therapy to treat symptoms and prevent progression. Oral steroids (e.g., prednisone) and off-label immunosuppressive therapies (e.g., methotrexate) are first- and second-line therapies respectively for sarcoidosis; however, these therapeutic options are often not effective or can be accompanied by serious side effects.

Evidence from non-clinical studies indicate that GM-CSF is a key cytokine driving granuloma formation and inflammation in sarcoidosis, and that inhibiting GM-CSF can reduce granuloma activity and the resulting inflammation, leading potentially to a reduction in symptoms and resolution of the underlying disease. Namilumab is a potent inhibitor of GM-CSF that has been observed to be generally safe and well-tolerated in more than 350 participants across multiple clinical trials. Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis.

“Pulmonary sarcoidosis is a complex and challenging condition, with limited treatment options, and many unacceptable side effects. There is a need for new and better therapies to be developed,” said Mary McGowan, CEO of the Foundation for Sarcoidosis Research. “We are proud to have worked with Kinevant on the successful enrollment of this clinical trial. We are grateful to the sarcoidosis patient community who embraced this opportunity to lead us toward a potential new therapy as well as a deeper understanding of sarcoidosis.”

About RESOLVE-Lung

The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis being conducted at multiple sites in the U.S. and Europe. The study has enrolled 107 pulmonary sarcoidosis patients considered not well-controlled despite available therapeutic options. Patients in the study receive a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. The goal of the study is to assess the efficacy and safety of namilumab in patients with pulmonary sarcoidosis during the 6-month blinded treatment period. The primary endpoint is the difference in the proportion of patients with a rescue event due to worsening of their pulmonary sarcoidosis. Secondary endpoints include changes in pulmonary function, patient reported outcomes, steroid use, safety, and tolerability. All patients who complete the 26-week double-blind treatment period are eligible to participate in a 28-week open-label extension treatment period on namilumab. More information can be found at www.sarcoidosistrial.com.

About Namilumab

Namilumab is an investigational, fully human monoclonal antibody formulated to be conveniently administered once a month as a subcutaneous injection. Namilumab is a potent GM-CSF inhibitor that has been well-tolerated so far in more than 350 participants across multiple clinical trials. Evidence from non-clinical studies indicate that GM-CSF promotes macrophage and dendritic cell activity which contributes to granuloma formation. Inhibiting GM-CSF can reduce the presence of granulomas and the resulting inflammation, potentially leading to a reduction in symptoms and resolution of the underlying disease.

About Kinevant Sciences

Kinevant Sciences, a subsidiary of Roivant, is a clinical-stage biopharmaceutical company developing new medicines for rare autoimmune and inflammatory diseases. The company takes a patient-first approach to drug development, advancing candidates with the potential to resolve the underlying disease and create life-changing benefit for patients. Kinevant is initially focused on the development of namilumab for the treatment of sarcoidosis, a multi-organ systemic disease with a high unmet medical need. For more information, visit www.kinevant.com or follow us on LinkedIn.

About Roivant

Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis, non-infectious uveitis, and other autoimmune conditions, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com.

Contacts

Jennifer Arcure

Senior Vice President

Inizio Evoke Comms

Jennifer.Arcure@inizioevoke.com

mRNA-1345 for Respiratory Syncytial Virus (RSV) in 7MM: Market Size, Forecasts, and Emerging Insights 2019-2032 – ResearchAndMarkets.com




mRNA-1345 for Respiratory Syncytial Virus (RSV) in 7MM: Market Size, Forecasts, and Emerging Insights 2019-2032 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “mRNA-1345 Market Size, Forecast, and Emerging Insight – 2032” report has been added to ResearchAndMarkets.com’s offering.

“mRNA-1345 Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about mRNA-1345 for Respiratory syncytial virus (RSV) in the seven major markets. A detailed picture of the mRNA-1345 for RSV in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the mRNA-1345 for RSV.

The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the mRNA-1345 market forecast analysis for RSV in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in RSV.

Drug Summary

The mRNA-1345 vaccine is a messenger RNA (mRNA) vaccine. This mRNA is entirely made in a laboratory and instructs the body to build small pieces of proteins. Moderna’s mRNA-1345 RSV vaccine candidate encodes for a prefusion F glycoprotein, eliciting a superior neutralizing antibody response.

In this case, the vaccine candidate contains the mRNA code for the RSV glycoprotein F, which does not cause RSV infection but helps the body’s immune system recognize and protect itself if it encounters the virus. Therefore, one cannot become infected with RSV by receiving the investigational vaccine. The mRNA-1345 RSV vaccine candidate prevents illness from RSV, a leading cause of respiratory illness in young and older adults (65+). Currently, the drug is in Phase III for older adults. mRNA-1345 is also ongoing in a Phase I trial in pediatric populations; RSV is also a large burden in the pediatric population.

RSV program has endorsed the start of the Phase III portion of the pivotal clinical study of mRNA-1345, the Company’s Respiratory Syncytial Virus (RSV) vaccine candidate, in adults 60 years and older. The DSMB’s endorsement comes after independent review of preliminary Phase II data, which suggest that the vaccine has an acceptable safety profile in older adults at the selected dose. This study is known as ConquerRSV.

mRNA-1345 Analytical Perspective

In-depth mRNA-1345 Market Assessment

This report provides a detailed market assessment of mRNA-1345 for Respiratory syncytial virus (RSV) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

mRNA-1345 Clinical Assessment

The report provides the clinical trials information of mRNA-1345 for RSV covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Respiratory syncytial virus (RSV) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence mRNA-1345 dominance.
• Other emerging products for RSV are expected to give tough market competition to mRNA-1345 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of mRNA-1345 in RSV.
• Our in-depth analysis of the forecasted sales data of mRNA-1345 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the mRNA-1345 in RSV.

Key Topics Covered:

1. Report Introduction

2. mRNA-1345 Overview in RSV

2.1. Product Detail

2.2. Clinical Development

2.2.1. Clinical studies

2.2.2. Clinical trials information

2.2.3. Safety and efficacy

2.3. Other Developmental Activities

2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. mRNA-1345 Market Assessment

5.1. Market Outlook of mRNA-1345 in RSV

5.2. 7MM Analysis

5.2.1. Market Size of mRNA-1345 in the 7MM for RSV

5.3. Country-wise Market Analysis

5.3.1. Market Size of mRNA-1345 in the United States for RSV

5.3.2. Market Size of mRNA-1345 in Germany for RSV

5.3.3. Market Size of mRNA-1345 in France for RSV

5.3.4. Market Size of mRNA-1345 in Italy for RSV

5.3.5. Market Size of mRNA-1345 in Spain for RSV

5.3.6. Market Size of mRNA-1345 in the United Kingdom for RSV

5.3.7. Market Size of mRNA-1345 in Japan for RSV

6. SWOT Analysis

7. Analysts’ Views

8. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/bccnqi

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Baseline Enrollment Completed for AMRA Medical and Linköping University’s Landmark Liver Disease Study




Baseline Enrollment Completed for AMRA Medical and Linköping University’s Landmark Liver Disease Study

The comprehensive ACCESS-ESLD study aims to validate novel biomarkers and imaging techniques for screening of hepatocellular carcinoma and sarcopenia in liver cirrhosis patients using a rapid, non-invasive clinical surveillance methodology, powered by AMRA’s MRI-based body composition technology

LINKÖPING, Sweden–(BUSINESS WIRE)–#AMRAMedical—AMRA Medical, a health informatics and precision medicine company that is pioneering body composition research through gold-standard MRI-based analysis platforms, in collaboration with Linköping University, is pleased to announce the completion of baseline enrollment for the innovative ACCESS-ESLD (A Rapid, Non-invasive, Clinical Surveillance for CachExia, Sarcopenia, Portal HypertenSion, and Hepatocellular Carcinoma in End-Stage Liver Disease) study. The nationally-comprised study population includes 150 liver cirrhosis patients aged 18 and up, with no liver transplant history or contraindications to performing an MRI examination, enrolled from one of three Swedish liver care clinics located in Linköping, Eksjö, or Jönköping. Over a duration of 2 years, patients will be assessed every 6 months with a comprehensive clinical examination and a whole-body MRI examination.

ACCESS-ESLD will characterize body composition using AMRA’s proprietary MRI-based health informatics platform to assess muscle volume (MV) and muscle fat infiltration (MFI), as well as measures of portal blood flow, liver stiffness, and spleen volume. These measures will be used to identify and validate risk factors and biomarkers that indicate current disease severity and predict future liver-related clinical events in patients with liver cirrhosis. AMRA’s muscle volume (MV) and muscle fat infiltration (MFI) measures have previously been shown to independently predict all-cause mortality¹ and comorbid vulnerability² in patients with fatty liver disease.

The primary objective of the study will be to determine whether or not changes in patient MV and MFI, either individually or in combination, can predict onset of events related to end-stage liver disease. Additionally, the investigators hope to identify predictors of mortality, assess non-invasive markers for portal hypertension, and evaluate how muscle composition and combined body profile assessments impact diagnosis, physical function and quality of life in patients with liver disease. The full manuscript detailing the ACCESS-ESLD study design and objectives was recently published in the journal BMC Gastroenterology in late 2023.

An indication that poses a significant clinical burden and unmet need for patients and providers, liver cirrhosis was historically centered around treatment of complications after they present in patients. The study investigators hope that the findings of ACCESS-ESLD will continue the shift in management of liver disease towards employing more of a preemptive approach, by developing ways to monitor disease progression and severity while also identifying novel biomarkers to help predict comorbid diseases/complications in patients.

“In Sweden, there’s a noticeable rise in liver disease, a condition often shadowed by social stigma and left neglected.” says Mattias Ekstedt at the department of health, medicine and caring sciences (HMV) at Linköping University. “The ACCESS-ESLD study promises to enhance our capabilities in detecting and tracking the progress of individuals living with liver disease, offering hope for better understanding and management of this health challenge.”

AMRA’s significant involvement in a hallmark study in the liver disease space such as this one embodies the company’s commitment to advancing both research and clinical care. Learn more about AMRA Medical and how the use of MRI-based body composition analysis is advancing disease research in liver disease and beyond.

References

1. Linge J, Nasr P, Sanyal A.J, Leinhard O.D, Ekstedt M, Adverse muscle composition is a significant risk factor for all-cause mortality in NAFLD, JHEP Reports, 2022: 5(3); 100663. https://doi.org/10.1016/j.jhepr.2022.100663

2. Linge J, Ekstedt M, Leinhard O.D, Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD. JHEP Reports, 2021: 3(1);100197. https://doi.org/10.1016/j.jhepr.2020.100197

About AMRA Medical

AMRA Medical is a health informatics and precision medicine company that is pioneering body composition analysis, providing cutting-edge solutions to advance both clinical research and patient care initiatives. AMRA’s gold-standard technology delivers multiple fat and muscle biomarkers – derived simply from rapid whole-body MRI scans. AMRA is committed to driving transformative care and simplifying vital decision-making in both research and clinical care settings by offering support services via their innovative platform.

Learn more about AMRA Medical’s MRI-based solutions at https://amramedical.com/solutions, or connect with our team of experts for a detailed discussion at info@amramedical.com.

Follow AMRA on LinkedIn for the latest updates in body composition and precision medicine.

Contacts

AMRA Medical

Marie Börjesson, VP Brand & Marketing

0046 70 628 1977

marie.borjesson@amramedical.com

Cybin to Participate at the 27th Annual Milken Institute Global Conference




Cybin to Participate at the 27th Annual Milken Institute Global Conference

– Doug Drysdale, CEO, to appear on panel entitled “Collaborating for Improved Mental Health,” on May 8, 2024 –

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that Doug Drysdale, Cybin’s Chief Executive Officer, will be speaking at the 27th Annual Milken Institute Global Conference on a panel entitled “Collaborating for Improved Mental Health.” The Conference will take place May 5-8, 2024, at the Beverly Hilton in Los Angeles, and the panel will be held on Wednesday, May 8, 2024, at 10:00 a.m. PDT.

“The Milken Institute Global Conference focuses on numerous global challenges across multiple domains, and we are thrilled to be part of the important conversation addressing today’s mental health crisis,” stated Doug Drysdale, Cybin’s Chief Executive Officer. “The Conference provides a meaningful platform to exchange ideas with global thought leaders and share our vision for transforming the treatment paradigm for mental health. With the recent receipt of FDA Breakthrough Therapy Designation for CYB003, our deuterated psilocybin analog for the adjunctive treatment of major depressive disorder entering a Phase 3 trial around mid-year; and CYB004, our deuterated DMT program in Phase 2 development for the treatment of generalized anxiety disorder, we are excited to share the groundbreaking work that Cybin is carrying out with the goal of bringing improved therapeutic options for treating mental health conditions.”

The live panel discussion and archived webcast will be available on the Company’s investor relations website on the Events & Presentations page. For more information on the Milken Institute and the upcoming conference visit www.milkeninstitute.org.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the spread of COVID-19 on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and nine month periods ended December 31, 2023, and the Company’s annual information form for the year ended March 31, 2023, which are available under the Company’s profile on www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Cboe Canada nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Contacts

Investor & Media:
Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com

Owlstone Medical Secures $6.5 Million to Support Development of Breath-based Diagnostics for Infectious Disease




Owlstone Medical Secures $6.5 Million to Support Development of Breath-based Diagnostics for Infectious Disease

• $5 million equity investment and initial $1.5 million grant funding committed by the Bill & Melinda Gates Foundation for development of breath-based diagnostic solutions to improve outcomes in the developing world
• Funding represents the first time the foundation has taken an equity position in a breath diagnostics company
• Funding will also support enhancement of the Breath Biopsy platform, including the VOC Atlas

CAMBRIDGE, England–(BUSINESS WIRE)–Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy^® for applications in early disease detection and precision medicine, today announced it has secured funding from the Bill & Melinda Gates Foundation (“the Gates Foundation” or “the foundation”). The funding is comprised of a $5 million equity investment to advance Owlstone’s Breath Biopsy platform and $1.5 million in grant funding to develop breath-based diagnostics and identify breath biomarkers for tuberculosis (TB) and HIV.

Owlstone, with support from the foundation, is interested in developing new cost-effective detection technologies for volatile organic compounds (VOCs) that could serve as markers of diseases that disproportionately affect the developing world. With the new funding, Owlstone seeks to understand whether this approach is suitable for TB and HIV detection and to explore a path by which breath-based testing could be deployed for rapid screening and earlier diagnosis.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Early diagnosis is a critical determinant of health outcomes. By enabling swift and non-invasive detection of disease, breath analysis has the potential to save lives and dramatically reduce the burden of illness in resource-constrained settings. This investment by the Gates Foundation is testament to how Owlstone is uniquely positioned to transform infectious disease diagnosis through our Breath Biopsy platform. The funds will accelerate both the discovery and validation of VOC biomarkers, and the development of a fieldable, low cost, simple to use device.”

The $5 million equity investment will support advancements of the Breath Biopsy platform, including expansion of the Breath Biopsy VOC Atlas¹ database and for development of a remote-use real-time breath analyzer. This component of the funding will be the first time that the foundation has taken an equity position in a breath diagnostics company.

The $1.5 million in grant funding to support the identification of breath biomarkers will be used across two projects:

• TB: In partnership with the University of Cape Town, South Africa, Owlstone aims to identify a panel of on-breath candidate VOC biomarkers that differentiate TB subjects from healthy controls and to develop breath diagnostic approaches based on exploiting the metabolic features of TB using in vitro approaches.
• HIV: Working with investigators from Imperial College, UK, and Oxford University, UK, Owlstone will analyze VOCs from blood samples from subjects with HIV and will work to identify a panel of on-breath candidate VOC biomarkers that correlate with HIV viral load.

In both areas, the data collected will also be used to further populate Owlstone’s Breath Biopsy VOC Atlas.

Activities complementary to this project are underway with the US Department of Defense² (the ‘EXHALE’ project) where Owlstone is developing a handheld device capable of non-invasive detection of pre-symptomatic respiratory infectious disease, providing further support for Owlstone’s ability to advance the foundation’s mission.

References:

1. https://www.owlstonemedical.com/science-technology/breath-biopsy-voc-atlas/
2. https://www.owlstonemedical.com/about/news/2023/may/17/OML-wins-DIU-contract/

Contacts

Dr Ben Rutter

Zyme Communications

ben.rutter@zymecommications.com
+44 (0) 7920-770935

MindMed to Present at Upcoming May Medical Conferences




MindMed to Present at Upcoming May Medical Conferences

NEW YORK–(BUSINESS WIRE)–$MNMD—Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it will present detailed results from its phase 2b study of MM120 in Generalized Anxiety Disorder (GAD), as well as multiple presentations describing the epidemiology and growing burden of GAD at two upcoming medical conferences:

American Psychiatric Association (APA) 2024 Congress, New York, NY

Title: Rapid and Durable Response to a Single Dose of MM120 (Lysergide) in Generalized Anxiety Disorder: A Dose-Optimization Study

Format: Poster

Presenter: Dan Karlin, MD

Date: Saturday, May 4, 2024

Title: Screening Adults in the US General Population to Detect Cases of Undiagnosed Generalized Anxiety Disorder

Format: Poster

Presenter: Phong Duong, PharmD

Date: Saturday, May 4, 2024

Title: Quantifying the Burden of Undiagnosed Generalized Anxiety Disorder in the US General Adult Population

Format: Poster

Presenter: Phong Duong, PharmD

Date: Saturday, May 4, 2024

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2024, Atlanta, GA

Title: Health-related Quality of Life Among Adults Diagnosed with Generalized Anxiety Disorder in the United States

Format: Poster

Presenter: Phong Duong, PharmD

Date: Monday, May 6, 2024

Title: Health Care Resource Use Associated with Undiagnosed and Diagnosed Generalized Anxiety Disorder Among Adults in the United States

Format: Poster

Presenter: Phong Duong, PharmD

Date: Monday, May 6, 2024

Title: Work Productivity Loss and Activity Impairment among Adults Diagnosed with Generalized Anxiety Disorder in the United States

Format: Poster

Presenter: Phong Duong, PharmD

Date: Wednesday, May 8, 2024

Posters will be available on MindMed’s Company website following the conferences.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed’s common shares trade on Nasdaq under the symbol MNMD.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated upcoming presentations; and the potential benefits of the Company’s product candidates. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, under headings such as “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.

Contacts

For Media: media@mindmed.co
For Investors: ir@mindmed.co

Vividion Therapeutics and Roche Jointly Publish Landmark Nature Paper on Clinical-Stage Covalent Allosteric Inhibitor of Werner Helicase (WRN)




Vividion Therapeutics and Roche Jointly Publish Landmark Nature Paper on Clinical-Stage Covalent Allosteric Inhibitor of Werner Helicase (WRN)

• VVD-133214 (also known as RO7589831), a promising drug candidate for patients with MSI-high cancers, is currently being evaluated in a Roche-sponsored Phase 1 first-in-human trial

SAN DIEGO–(BUSINESS WIRE)–Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high-value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, today announced a landmark publication in Nature. The publication, “Chemoproteomic Discovery of a Covalent Allosteric Inhibitor of WRN Helicase,” by Kristen Baltgalvis et al, published jointly with our partner Roche, speaks to the chemical proteomic-enabled discovery of a clinical-stage, covalent allosteric inhibitor of Werner helicase (WRN), VVD-133214 (RO7589831), and further confirms Vividion’s approach to discovering and developing novel therapeutics.

“Vividion discovered covalent ligands targeting a novel allosteric pocket on WRN, a well- known but challenging therapeutic target in drug development. The discovery of this allosteric pocket, early ligands and the lead series were directly enabled by Vividion’s innovative approach to drug discovery, including our chemoproteomics platform and unique covalent fragment library,” said Matt Patricelli, Ph.D., Chief Scientific Officer of Vividion.

WRN is a highly sought after synthetic lethal target for cancers with microsatellite instability (MSI), a genetic state resulting from mutations in DNA damage response pathway genes. MSI is most common in colorectal, endometrial and stomach cancers. The WRN molecule was identified under the collaboration agreement entered between Vividion and Roche in 2020. Roche is currently investigating VVD-133214, also known as RO7589831, in a Phase 1 clinical trial (NCT06004245).

“It has been a privilege partnering with Vividion on this significant oncology target, harnessing their leading platform capabilities, and successfully progressing an exceptional molecule into clinical trials within three years from its inception,” said Chris Claiborne, Ph.D., Head, Small Molecule Research and Head of Cancer Cell Targeted Therapy, Roche pharma Research and Early Development (pRED).

“The publication of Vividion’s allosteric WRN inhibitor in Nature and being one of the first to the clinic on such a challenging target, highlights the ability of Vividion’s covalent chemoproteomic platform to identify and advance druggable vulnerabilities on historically challenging targets,” said Ben Cravatt, Ph.D., Scientific Founder of Vividion.

About Vividion

Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG acquired in August 2021, is a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The company’s platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high value, traditionally undruggable targets in oncology and immunology. For more information, please visit www.vividion.com.

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

Contacts

Vividion Therapeutics

Laurie Sherman

+1 (858) 630-8246

media@vividion.com