HLHS

Longeveron Announces Pricing of $5.25 Million Public Offering

Retrieved on: 
Monday, April 8, 2024
3rd Floor, Form, Hypoplastic left heart syndrome, Sale, Public expenditure, Security (finance), HLHS, Prospectus

The closing of the offering is expected to occur on or about April 10, 2024, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to occur on or about April 10, 2024, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to the Company from the offering are expected to be approximately $5.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • The offering is being made only by means of a prospectus, which forms a part of the effective registration statement.
  • A preliminary prospectus relating to the public offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov .

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024
DREAM, RPD, Growth, PLI, SIX, BMT, FIRST, Diagnosis, Mortality, Bangladesh Technical Education Board, Blood, HLHS, MSB, Degenerative disc disease, NIH, Marketing, Pain, MACE, BLA, Survival, Heart failure, Hypoplastic left heart syndrome, LVAD, Randomized controlled trial, FINANCIAL, Inflammation, Biopharmaceutical, ODD, Heart, Mesoblast, Regenerative Medicine Advanced Therapy, FDA, Priority review, MESO, Risk, Administration, Death, Patient, PRV, DDD, Pharmaceutical industry

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Retrieved on: 
Thursday, February 15, 2024
Mesoblast, HLHS, MSB, Randomized controlled trial, FDA, Growth, Inflammation, MESO, Risk, Heart failure, ODD, Death, Hypoplastic left heart syndrome, Pharmaceutical industry

This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.

Key Points: 
  • This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.
  • Mesoblast Chief Executive Silviu Itescu said: “We are very pleased to have now been granted both Orphan-Drug Designation and Rare Pediatric Disease Designation by FDA for REVASCOR in the treatment of children with this often-fatal congenital heart condition.
  • The designations were granted on the back of the results from children in a randomized controlled trial indicating that REVASCOR may increase the ability to successfully accomplish life-saving surgery.
  • Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure and death.

Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023

Retrieved on: 
Wednesday, January 31, 2024
Congenital heart defect, FDA, Appendix, MSB, Journal, Bangladesh Technical Education Board, PRV, Survival, Randomized controlled trial, Biopharmaceutical, GVHD, Phases of clinical research, BLA, Hypoplastic left heart syndrome, RPD, HLHS, Growth, Patient, Blood, Inflammation, Priority review, Heart, NIH, Pain, Mesoblast, Ageing, BMT, Executive, MESO, Pharmaceutical industry

NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.

Key Points: 
  • NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.
  • Mesoblast will provide the Phase 3 trial protocol to FDA ahead of the upcoming meeting this quarter.
  • Mesoblast will meet with FDA this quarter to address potential pathways to approval for REVASCOR under our Regenerative Medicine Advanced Therapies (RMAT) designation.
  • Revenue from royalties on sales of TEMCELL® HS Inj.5 sold in Japan by our licensee for the quarter were US$1.5 million.

Longeveron Receives Notice of United States Patent Allowance for the Technology Behind its Lead Investigation Product Lomecel-B™

Retrieved on: 
Monday, January 29, 2024
Entrepreneurship, Patient, European, Stem cell, FAHA, COVID-19, Safety, Medicine, FACC, Regenerative medicine, HLHS, PMDA, Patent, Hypoplastic left heart syndrome, ASRM, Vaccine, Microsoft Exchange Server, Immune system

The allowance impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu.

Key Points: 
  • The allowance impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu.
  • The new U.S. patent adds to the intellectual property from previous patents issued to Longeveron in the European Union and Japan.
  • Longeveron currently is conducting a trial of Aging-related Frailty in Japan aligned with the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
  • Longeveron’s Patent Application 16/075,276 was titled Mesenchymal Stem Cells as Vaccine Adjuvants and Methods for Using the Same.

United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Retrieved on: 
Thursday, January 18, 2024
PRV, Death, Mesoblast, Heart, RPD, Hypoplastic left heart syndrome, Heart failure, Risk, Priority review, Inflammation, MESO, FDA, BLA, HLHS, MSB, Biopharmaceutical, Randomized controlled trial, Growth, Pharmaceutical industry

NEW YORK, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) a Rare Pediatric Disease (RPD) Designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition.

Key Points: 
  • RPD Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children.
  • On FDA approval of a Biologics Licensing Application (BLA) for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.
  • In the HLHS trial conducted in 19 children, a single intramyocardial administration of REVASCOR at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular (LV) end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography, (p=0.009 & p=0.020 respectively).
  • Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure and death.

Longeveron Announces Closing of $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Friday, December 22, 2023
Regulation D, Sale, Hypoplastic left heart syndrome, Form, 3rd Floor, Prospectus, HLHS, Security (finance)

In a concurrent private placement, Longeveron issued unregistered warrants to purchase up to an aggregate of 1,355,301 shares of its common stock.

Key Points: 
  • In a concurrent private placement, Longeveron issued unregistered warrants to purchase up to an aggregate of 1,355,301 shares of its common stock.
  • The gross proceeds to Longeveron from the offering are approximately $2.36 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • Longeveron currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
  • A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering was filed with the SEC on December 22, 2023.

UPDATE -- Longeveron Announces $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Thursday, December 21, 2023
Regulation D, Sale, Hypoplastic left heart syndrome, Form, 3rd Floor, HLHS, Security (finance)

The offering is expected to close on or about December 22, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The offering is expected to close on or about December 22, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to Longeveron from the offering are expected to be approximately $2.36 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • Longeveron currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
  • The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement.

Longeveron Announces $2.36 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Thursday, December 21, 2023
Regulation D, Sale, Hypoplastic left heart syndrome, Form, 3rd Floor, HLHS, Security (finance)

The offering is expected to close on or about December 26, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The offering is expected to close on or about December 26, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to Longeveron from the offering are expected to be approximately $2.36 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • Longeveron currently intends to use the net proceeds from the offering for working capital and general corporate purposes.
  • The offering of the shares of common stock to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement.

Longeveron Announces Additional Positive Clinical Data and Imaging Biomarker Results from the CLEAR MIND Phase 2a Trial of Lomecel-B™ in the Treatment of Mild Alzheimer’s Disease

Retrieved on: 
Wednesday, December 20, 2023
Quality of life, MRI, Hippocampus, Hypoplastic left heart syndrome, Diffusion MRI, Neuron, Disease, Brain, Incidence, Hypersensitivity, Magnetic resonance imaging, CLEAR, Week, Mini–Mental State Examination, Dementia, Degree, Atrophy, TBV, EKG, DTI, Patient, Thalamus, Magnetic resonance, Safety, Siderosis, HLHS, Alzheimer's disease, Medical imaging

The expanded data set reinforced the earlier top-line findings showing that the primary safety endpoint was met and provided further support for Lomecel-B’s positive benefit/risk profile.

Key Points: 
  • The expanded data set reinforced the earlier top-line findings showing that the primary safety endpoint was met and provided further support for Lomecel-B’s positive benefit/risk profile.
  • Wa’el Hashad, CEO of Longeveron, commented: “These new data support our initial results for CLEAR MIND that we announced in October and provide further validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease.
  • In addition to these clinical findings, brain imaging showed improvement in brain architecture measured by volumetric MRI and DTI, respectively.
  • Taken together, the Company believes the results of the CLEAR MIND study build a strong foundation for further development in mild Alzheimer's disease patients.