Ongo

Applied Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics, presented the data in an oral Symposium entitled Diabetic Cardiomyopathy (DbCM): a severe complication of diabetes.
  • Cash and cash equivalents and short-term investments totaled $37.5 million as of September 30, 2023, compared with $30.6 million at December 31, 2022.
  • Net loss for the third quarter of 2023 was $42.4 million, or $0.47 per basic and diluted common share, compared to a net loss of $19.1 million, or $0.40 per basic and diluted common share, for the third quarter 2022.

Design Therapeutics Provides Pipeline Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 14, 2023

CARLSBAD, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today provided business updates and anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC™ small molecules and reported second quarter 2023 financial results.

Key Points: 
  • CARLSBAD, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today provided business updates and anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC™ small molecules and reported second quarter 2023 financial results.
  • With an expert team and strong financial position afforded by efficient cost and program management, I am confident in our ability to execute our goals.
  • The company plans to submit an IND for DT-168 in the second half of 2023.
  • Cash Position and Operating Runway: Cash, cash equivalents and marketable securities were $303.1 million as of June 30, 2023.

Applied Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • “In the second quarter we continued to advance our programs across Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board.
  • In June 2023, the Company presented baseline data at the 2023 Annual Meeting of the ADA from the ongoing Phase 3 ARISE-HF study of AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM).
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Net loss for the second quarter of 2023 was $29.6 million, or $0.37 per basic and diluted common share, compared to a net loss of $25.9 million, or $0.96 per basic and diluted common share, for the second quarter 2022.

NewAmsterdam Pharma Announces Positive Topline Results from Phase 2b Dose-Finding Trial Evaluating Obicetrapib in Japanese Patients

Retrieved on: 
Monday, June 5, 2023

-- Management to Host Conference Call Today at 8:00 a.m. E.T. --

Key Points: 
  • Based on the results observed, NewAmsterdam plans to leverage data from the ongoing Phase 3 BROOKLYN, BROADWAY and PREVAIL clinical trials, if supportive, to pursue regulatory approval in Japan.
  • The Phase 2b trial was a placebo-controlled, double-blind, randomized, dose-finding trial to evaluate the efficacy, safety and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients.
  • NewAmsterdam anticipates sharing full data from this Phase 2b clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.
  • ET to review these data, as well as the full data from the Phase 2 ROSE2 clinical trial, which were presented on Saturday.

Design Therapeutics Provides Pipeline Updates and Reports First Quarter 2023 Financial Results

Retrieved on: 
Tuesday, May 9, 2023

CARLSBAD, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today provided updates and anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTAC™ small molecules and reported first quarter 2023 financial results.

Key Points: 
  • “2023 is poised to be an important year for Design as we work to bring our novel GeneTAC™ small molecules closer to patients suffering from devastating genetic diseases,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics.
  • Design now anticipates presenting initial results from the MAD trial in the third quarter of 2023.
  • R&D Expenses: Research and development (R&D) expenses were $15.7 million for the quarter ended March 31, 2023.
  • Net Loss: Net loss was $19.3 million for the quarter ended March 31, 2023.

C4 Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, May 4, 2023

WATERTOWN, Mass., May 04, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the first quarter ended March 31, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the first quarter of 2023 was $3.8 million, compared to $7.7 million for the first quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the first quarter of 2023 was $29.0 million, compared to $26.2 million for the first quarter of 2022.
  • General and Administrative (G&A) Expense: G&A expense for the first quarter of 2023 was $10.9 million, compared to $12.8 million for the first quarter of 2022.
  • Net loss per share for the first quarter of 2023 was $0.71 compared to $0.65 for the first quarter of 2022.

Applied Therapeutics Reports Fourth Quarter and Year-end 2022 Financial Results

Retrieved on: 
Thursday, March 23, 2023

NEW YORK, March 23, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • “We are pleased with the clinical progress in 2022 across all three of our registrational Phase 3 programs, and we look forward to the data readouts in the year ahead,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • In February 2023, the Company announced positive sorbitol reduction data from the ongoing global Phase 3 INSPIRE trial.
  • Cash and cash equivalents and short-term investments totaled $30.6 million as of December 31, 2022, compared with $80.8 million at December 31, 2021.
  • General and administrative expenses were $27.3 million for the year ended December 31, 2022, compared to $43.0 million for the year ended December 31, 2021.

Atossa Therapeutics Announces Year-End 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 22, 2023

Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for ER+ patients, which account for approximately 78% of breast cancers.

Key Points: 
  • Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for ER+ patients, which account for approximately 78% of breast cancers.
  • We expect to enroll approximately 175 patients at up to 25 sites across the United States.
  • Continued Enrollment in Phase 2 Karisma-Endoxifen Study – The Karisma-Endoxifen study is our randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density.
  • Our investment totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT.

Adicet Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, March 15, 2023

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2022.
  • Enrollment in the trial is currently ongoing to provide additional durability data and further support the recommended Phase 2 dose.
  • In November 2022, Adicet announced the appointment of Dr. Nancy Boman, M.D., Ph.D., as Senior Vice President and Chief Regulatory Officer.
  • In the fourth quarter of 2022, Adicet’s new in-house manufacturing capabilities in its Redwood City facility became operational.

C4 Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, February 23, 2023

WATERTOWN, Mass., Feb. 23, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported business highlights and financial results for the year ended December 31, 2022.

Key Points: 
  • CFT8634: CFT8634 is an oral degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.
  • Dosed First Patient in Phase 1/2 Clinical Trial: In January 2023, dosed the first patient in the CFT1946 Phase 1/2 clinical trial.
  • The increase in G&A expense was primarily attributable to the full-year 2022 impact of the build-out of our general and administrative team to support business growth.
  • Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2022 was $337.1 million, compared to $451.5 million as of December 31, 2021.