LVEF

Appendix 4C Quarterly Activity Report

Retrieved on: 
Friday, April 28, 2023
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NEW YORK, April 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2023.

Key Points: 
  • NEW YORK, April 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2023.
  • Successful completion of a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs.
  • Revenue from royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our licensee for the quarter were US$1.8 million.
  • The data from both studies formed key components of Mesoblast’s recent resubmission of its remestemcel-L BLA to FDA for children with SR-aGVHD.

Affluent Medical : 2022 full year results and update on clinical activities under development.

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Friday, March 31, 2023
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Affluent Medical : 2022 full year results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2022 full year results and update on clinical activities under development.
  • Excellent interim results from the Optimise II pivotal study for the KaliosTM mitral ring and increase in the number of clinical centers.
  • New sources of financing to support the advancement of the three clinical studies and the next development steps.
  • On March 9, 2023, Affluent Medical announced the first successful clinical implantation of its Epygon transcatheter mitral heart valve in a patient in Italy.

Monopar Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Developments

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Thursday, March 23, 2023
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WILMETTE, Ill., March 23, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2022 financial results and summarized recent developments.

Key Points: 
  • WILMETTE, Ill., March 23, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2022 financial results and summarized recent developments.
  • Results for the Fourth Quarter and Year Ended December 31, 2022, Compared to the Fourth Quarter and Year Ended December 31, 2021
    Cash, cash equivalents and short-term investments as of December 31, 2022, were $13.1 million.
  • R&D expenses for the fourth quarter of 2022 were $2.1 million compared to $2.0 million for the fourth quarter of 2021.
  • G&A expenses for the fourth quarter of 2022 were $0.8 million, compared to $0.7 million for the fourth quarter of 2021.

Two-Year Study Data for EVBA Procedure with Unique MobiusHD Device Presented at Technology and Heart Failure Therapeutics Meeting

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Wednesday, March 22, 2023
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Vascular Dynamics, Inc. (VDI) , a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic heart failure were presented today at the Technology and Heart Failure Therapeutics ( THT ) 2023 meeting in Boston.

Key Points: 
  • Vascular Dynamics, Inc. (VDI) , a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic heart failure were presented today at the Technology and Heart Failure Therapeutics ( THT ) 2023 meeting in Boston.
  • The data , presented by JoAnn Lindenfeld, MD, a heart failure specialist at Vanderbilt University Medical Center and Past President of the Heart Failure Society of America, focused on the efficacy of the MobiusHD device implantation in progressive heart failure patients who were previously highly symptomatic despite guideline-directed medical therapy.
  • These results provide evidence suggesting a clinically meaningful and durable benefit of endovascular baroreflex amplification (EVBA) in specific heart failure patients.
  • In this way, the MobiusHD offers a potential device-based solution for symptomatic heart failure patients who are not responding to drug treatment.

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

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Wednesday, March 22, 2023
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Ancora Heart, Inc ., a company developing a completely transcatheter device-based therapy to address heart failure (HF), today announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.

Key Points: 
  • Ancora Heart, Inc ., a company developing a completely transcatheter device-based therapy to address heart failure (HF), today announced that patients treated with the investigational AccuCinch® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.
  • The 12-month data were presented as part of a late-breaking clinical science session at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously published in the Journal of Cardiac Failure .
  • “This analysis shows patients treated with the AccuCinch System experienced meaningful improvement in efficacy measures important to both clinicians and patients,” said Dr. Hamid.
  • “We witnessed significant and progressive reverse remodeling of the left ventricle, as well as significant and sustained improvement in quality of life and functional capacity measures.

Positive Echocardiography Data from BioCardia Phase III CardiAMP Cell Therapy Heart Failure Trial Presented at American College of Cardiology Annual Meeting

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Monday, March 6, 2023
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SUNNYVALE, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces that detailed echocardiography data from the roll-in cohort of the Phase III CardiAMP® Cell Therapy Heart Failure Trial is being presented today at the American College of Cardiology annual meeting by Peter Johnston, M.D., Assistant Professor of Medicine and Site Principal Investigator at Johns Hopkins University. The echocardiography results from baseline through one and two years showed a more than doubling in the number of heart segments functioning normally and restoration of function to 30 percent of previously non-functioning segments. This data expands upon data previously presented at the Heart Failure Society of America annual meeting last fall.

Key Points: 
  • This data expands upon data previously presented at the Heart Failure Society of America annual meeting last fall.
  • In completely non-functioning heart segments, 17 of 56, or 30 percent, of those heart segments resumed wall motion by two years.
  • In the previously presented data, patient demographics at study start demonstrated characteristics typical of the target population of NYHA class II and III ischemic heart failure patients with reduced ejection fraction.
  • “These early results lend further support to the potential efficacy of the autologous CardiAMP cell therapy and to our mission of restoring heart health,” said BioCardia CEO Peter Altman, PhD.

TAGRISSO® (osimertinib) demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

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Thursday, March 9, 2023
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In May 2020 , AstraZeneca announced TAGRISSO demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in this setting.

Key Points: 
  • In May 2020 , AstraZeneca announced TAGRISSO demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in this setting.
  • Per the ADAURA trial protocol, patients on placebo that recurred with metastatic disease had the opportunity to receive open-label TAGRISSO.
  • AstraZeneca has a comprehensive portfolio of approved and potential new medicines in development for patients with lung cancer.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% of cases were fatal.

Cytokinetics Presents Positive Results From Cohort 4 of REDWOOD-HCM and Long-Term Results From FOREST-HCM at the American College of Cardiology 72nd Annual Scientific Session

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Saturday, March 4, 2023
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SOUTH SAN FRANCISCO, Calif., March 04, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that positive results from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), were presented at the American College of Cardiology 72nd Annual Scientific Session (ACC.23). Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.

Key Points: 
  • Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.
  • At 10 weeks, patients in Cohort 4 experienced significant improvements in NT-proBNP, with an average decrease of 66% (p
  • The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics ACC.23 Conference Call .
  • An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology (JACC)

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Monday, February 27, 2023
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NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC).

Key Points: 
  • NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC).
  • Locally, in the heart, the MPCs can protect cardiac muscle cells from dying and can improve blood flow and energetics.
  • In large blood vessels throughout the body, the reduced inflammation resulting from the activation of MPCs may decrease plaque instability, which is what leads to heart attacks and strokes.
  • “The results of DREAM-HF suggest those patients with heart failure with preserved ejection fraction (HFpEF) and other cardiomyopathies could potentially benefit from MPC therapy as well.

Edgewise Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights

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Thursday, February 23, 2023
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Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today reported financial results for the fourth quarter and full year of 2022 and recent business highlights.

Key Points: 
  • Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today reported financial results for the fourth quarter and full year of 2022 and recent business highlights.
  • Research and development (R&D) expenses were $16.6 million for the fourth quarter 2022, compared to $13.9 million for the immediately preceding quarter.
  • General and Administrative (G&A) expenses were $5.5 million for the fourth quarter 2022, compared to $4.4 million for the immediately preceding quarter.
  • Net loss and net loss per share for the fourth quarter of 2022 was $19.4 million or $0.31 per share, compared to $17.5 million or $0.34 per share for the immediately preceding quarter.