Secretome

KALA BIO Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024
Retina, Chair, Three Months, Biologics license application, Secretome, Disease, Infection, Incidence, Paratriathlon, Inflammation, Patient, Sale, Limbal stem cell, Research, CIRM, Acquisition, Commercial, Eye, Safety, Retinitis pigmentosa, Food, FDA, BLA, Stargardt disease, Physician, Contingency, Protease, Cryptocurrency

ARLINGTON, Mass., March 29, 2024 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • “In 2023, we focused on clinical execution, advancing our Phase 2b CHASE trial of KPI-012 for the treatment of PCED.
  • In December 2023 and March 2024, KALA announced private placement financings with an institutional investor, priced at-the-market under Nasdaq rules.
  • Cash Position: As of December 31, 2023, KALA had cash and cash equivalents of $50.9 million, compared to $56.1 million as of September 30, 2023.
  • Operating Loss: For the quarter ended December 31, 2023, loss from operations was $9.6 million, compared to $10.3 million for the same period in 2022.

Carmell to Host Investor Webinar, “Unveiling the Secretome: On the Eve of Product Launch” Featuring Key Opinion Leaders in the Medical Aesthetics Field

Retrieved on: 
Monday, March 18, 2024
Harvard Medical School, Worldwide, Research, Doctor of Philosophy, Protein, Regius Professor, Skin, Secretome, Safety, FACS, FRCS, BLA, Peptide, Vaccine

Carmell's Secretome technology delivers 1000+ growth factors, proteins and peptides extracted from allogeneic human platelets in a twelve-month shelf-stable and biologically active formulation.

Key Points: 
  • Carmell's Secretome technology delivers 1000+ growth factors, proteins and peptides extracted from allogeneic human platelets in a twelve-month shelf-stable and biologically active formulation.
  • Carmell’s technology was previously being developed as a BLA and has Phase 2 human clinical data supporting safety and efficacy.
  • In comparison, other aesthetic products feature 1-2 synthetic proteins with sparse evidence of clinical efficacy.
  • Carmell aims to launch a limited-edition product this month followed by 9 other skincare products over the summer 2024.

KALA BIO Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Sale, Eye, Stargardt, Three Months, Protease, Acquisition, Research, Safety, Retinitis pigmentosa, Food, BLA, D, Commercial, Chair, CIRM, Stem cell, Patient, Secretome, FDA, CHASE, MSC, Infection, Stargardt disease, R, Nine Months, Paratriathlon, Biologics license application, Contingency, Pharmaceutical industry, Cryptocurrency, Vaccine, Clothing, Video game, Fine chemical, Life insurance, Security (finance), Drug, Alcon

ARLINGTON, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research and development of innovative therapies for rare and severe diseases of the eye, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Cash Position: As of September 30, 2023, KALA had cash and cash equivalents of $56.1 million, compared to $70.5 million as of December 31, 2022.
  • R&D Expenses: For the quarter ended September 30, 2023, research and development (R&D) expenses were $5.6 million, compared to $5.4 million for the same period in 2022.
  • Operating Loss: For the quarter ended September 30, 2023, loss from operations was $8.8 million, compared to $14.6 million for the same period in 2022.
  • The weighted average number of shares used to calculate net loss/income per share was 2.6 million for the quarter ended September 30, 2023 and 1.5 million for the quarter ended September 30, 2022.

KALA BIO Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, August 4, 2023
Infection, Biologics license application, California Institute for Regenerative Medicine, Loss, Cornea, SG, Stargardt disease, Contingency, Eye, Stargardt, Research, CHASE, Retinitis pigmentosa, Secretome, Sale, Regenerative medicine, Acquisition, MSC, Patient, Investment, Protease, CIRM, R, Paratriathlon, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Three Months, KALA, Food, Chair, D, Pharmaceutical industry, Cryptocurrency, Clothing, Video game, Fine chemical, Life insurance, Reinsurance, Alcon

ARLINGTON, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (Nasdaq:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • In August 2023, KALA BIO changed its name from Kala Pharmaceuticals, Inc. to better reflect the company’s focus on advancing novel biologics for the treatment of ophthalmic conditions.
  • Financial Results for the Three Months Ended June 30, 2023:
    Net Product Revenues: KALA did not recognize product revenues in the second quarter of 2023 as a result of the sale of its commercial portfolio to Alcon Inc. (Alcon) on July 8, 2022.
  • Cost of Product Revenues: KALA did not record cost of product revenues in the second quarter of 2023 as a result of the sale of its commercial portfolio to Alcon.
  • The weighted average number of shares used to calculate net loss per share was 2.2 million for the quarter ended June 30, 2023 and 1.5 million for the quarter ended June 30, 2022.

Kala Pharmaceuticals Announces Name Change to KALA BIO

Retrieved on: 
Wednesday, August 2, 2023
BIO, Stargardt disease, Eye, Stargardt, Stem cell, Research, Cornea, CHASE, Retinitis pigmentosa, Secretome, Patient, CUSIP, KALA, Safety, Chair, Pharmaceutical industry

“KALA BIO is committed to developing innovative therapies for rare and severe diseases of the eye,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO.

Key Points: 
  • “KALA BIO is committed to developing innovative therapies for rare and severe diseases of the eye,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO.
  • KALA BIO’s most advanced MSC-S is KPI-012, which is currently in Phase 2b clinical development for the treatment of PCED.
  • KALA BIO has also initiated preclinical studies for its KPI-014 program, evaluating the utility of its MSC-S platform for inherited retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease.
  • In connection with the name change, KALA BIO’s corporate website address remains unchanged at www.kalarx.com.

Secretome Therapeutics Appoints Deepa Prasad as Chief Financial Officer

Retrieved on: 
Monday, June 26, 2023
Science, Cardiology, Stem Cells, Other Science, Biotechnology, Research, Health, Clinical Trials, University of California, Berkeley, Therapy, VTV, Business, General partnership, Kellogg School, Business administration, Blue Shield, UC, Design, Optum, Knowledge, Northwestern University, Secretome, Pharmaceutical industry, Management

Secretome Therapeutics, a biotechnology company developing first-in-class therapeutics derived from neonatal mesenchymal stem cells (nMSC) for the treatment of underserved diseases, today announced the appointment of Deepa Prasad as Chief Financial Officer.

Key Points: 
  • Secretome Therapeutics, a biotechnology company developing first-in-class therapeutics derived from neonatal mesenchymal stem cells (nMSC) for the treatment of underserved diseases, today announced the appointment of Deepa Prasad as Chief Financial Officer.
  • "Deepa brings a wealth of knowledge through her combination of investment banking, operations, and venture capital experience in the life science industry," said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics.
  • I believe that secretomes represent a true breakthrough in the field of cell-based therapy, and I look forward to helping Secretome transform the way we treat diseases," said Ms. Prasad.
  • Previous to vTv, she was General Partner at WestRiver Group where she led healthcare investments in numerous companies, including Design Therapeutics.

Kala Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 9, 2023
Infection, Biologics license application, California Institute for Regenerative Medicine, SG, Stargardt disease, Contingency, Eye, Clinical trial, Stargardt, Fast Track, Stem cell, Research, CHASE, Retinitis pigmentosa, Secretome, QID, Sale, Regenerative medicine, Acquisition, Patient, Protease, CIRM, Paratriathlon, FDA, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, KALA, Food, D, Pharmaceutical industry, Cryptocurrency, Video game, Alcon

ARLINGTON, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • In April 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for KPI-012 for the treatment of PCED.
  • Cash and cash equivalents as of March 31, 2023 exclude anticipated funding from the $15 million grant awarded by CIRM in April 2023.
  • First Quarter 2023 Financial Results:
    Net Product Revenues: Kala did not recognize product revenues in the first quarter of 2023, as a result of the sale of its commercial portfolio to Alcon Inc. (Alcon) on July 8, 2022.
  • Operating Loss: For the quarter ended March 31, 2023, loss from operations was $11.7 million, compared to $30.9 million for the same period in 2022.

Combangio, Inc., a Wholly Owned Subsidiary of Kala Pharmaceuticals, Awarded $15 Million by California Institute for Regenerative Medicine to Support Ongoing KPI-012 Program for the Treatment of PCED

Retrieved on: 
Friday, April 28, 2023
Biologics license application, California Institute for Regenerative Medicine, Eye, Research, Cornea, CHASE, Secretome, QID, Regenerative medicine, Patient, CIRM, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, KALA, Food, Safety, Wound healing, Pharmaceutical industry

The grant includes funding for the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial as well as product and process characterization and analytical development for the program.

Key Points: 
  • The grant includes funding for the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial as well as product and process characterization and analytical development for the program.
  • “KPI-012’s differentiated product profile has the potential to deliver rapid and sustained wound healing with broad-based application across all underlying PCED etiologies.
  • The primary endpoint of the trial is the complete healing of the PCED as measured by corneal fluorescein staining.
  • “We are honored that CIRM has recognized KPI-012’s potential to correct impaired corneal healing,” said Mark Iwicki, Chief Executive Officer and Chairman of Kala Pharmaceuticals.

Kala Pharmaceuticals Receives FDA Fast Track Designation for KPI-012, a Human MSC-S Therapy for Persistent Corneal Epithelial Defect

Retrieved on: 
Wednesday, April 12, 2023
Infection, Biologics license application, Eye, Paratriathlon, Fast Track, Research, Cornea, Secretome, QID, Pain, Patient, Corneal perforation, FDA, Kala, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, KALA, Food, Safety, Pharmaceutical industry, Agency

The purpose of this designation is to help speed development of new drugs, making them available to the patient more quickly.

Key Points: 
  • The purpose of this designation is to help speed development of new drugs, making them available to the patient more quickly.
  • A company with a therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the product development plan.
  • Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.
  • In February 2023, Kala dosed the first patient in its CHASE (Corneal Healing After SEcretome therapy) Phase 2b trial evaluating KPI-012 for the treatment of PCED.

Kala Pharmaceuticals Appoints Dr. Francis Mah as Chief Medical Advisor

Retrieved on: 
Wednesday, March 29, 2023
Francis, University, Refractive surgery, Medical college, Cataract, Eye, American Academy, Research, CHASE, Secretome, Dartmouth College, American Society of Cataract and Refractive Surgery, Patient, Executive Committee, S-1 Executive Committee, Rare, Society, Basic, KALA, Safety, Wound healing, Pharmaceutical industry, Ophthalmology

ARLINGTON, Mass., March 29, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the appointment of Francis Mah, M.D., as Chief Medical Advisor.

Key Points: 
  • ARLINGTON, Mass., March 29, 2023 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the appointment of Francis Mah, M.D., as Chief Medical Advisor.
  • In this newly established role, Dr. Mah will provide support for Kala’s clinical development and medical activities and will play a key role in interactions with eye care professionals.
  • “We are thrilled to welcome Francis to Kala as our Chief Medical Advisor.
  • “I am particularly excited to partner with the Kala team to advance KPI-012 for the treatment of PCED.