GRECO

Galera Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, March 28, 2024
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We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.

Key Points: 
  • We are continuing to explore strategic options to maximize value to our shareholders, including a potential development path for avasopasem.
  • The Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA was August 9, 2023.
  • Research and development expenses were $3.2 million in the fourth quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $2.0 million in the fourth quarter of 2023, compared to $5.0 million for the same period in 2022.

Galera Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, November 14, 2023
NDA, Cisplatin, Disclosure, Galera, Chronic kidney disease, Annual general meeting, Superoxide dismutase, ASN, ASTRO, Food, Type, SBRT, Head, Incidence, Investment, New Drug Application, Clinical trial, American Society of Nephrology, Insurance, Patient, Workforce, Research, Radiation therapy, Death, FDA, CKD, Neoplasm, LAPC, Therapy, Manganese, Enterocyte, GRECO, Cancer, CRL, Symantec Endpoint Protection, Combination, Superoxide dismutase mimetics, Layoff, Society, HNC, Poster, Pharmaceutical industry

MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates.

Key Points: 
  • The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources.
  • Research and development expenses were $6.1 million in the third quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022.
  • As of September 30, 2023, Galera had cash, cash equivalents and short-term investments of $28.4 million.

Galera Announces Receipt of Type A Meeting Minutes and Strategic Update

Retrieved on: 
Tuesday, October 31, 2023
Type, FDA, Sale, SOM, LAPC, Therapy, Manganese, Death, GRECO, Galera, Lung cancer, NDA, Cancer, Investment, Patient, SBRT, Pharmaceutical industry, Stifel

MALVERN, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM. The Company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer (LAPC) and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer (NCSLC), following a futility analysis of the GRECO-2 trial. The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.

Key Points: 
  • The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.
  • In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the Company’s New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM.
  • If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether.
  • Galera estimates that its balance of cash, cash equivalents and short-term investments as of September 30, 2023 was $28.4 million.

Galera Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Monday, August 14, 2023
Workforce, Pancreatic cancer, SBRT, HNC, Therapy, Symantec Endpoint Protection, LAPC, Head, Glomerular filtration rate, Clinical trial, Survival, NDA, Cancer, New Drug Application, NSCLC, Cisplatin, ASCO, SOM, Radiation, GRECO, Patient, Investment, Annual general meeting, CRL, Research, FDA, Galera, CKD, Society, Food, Safety, Pharmaceutical industry

MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.

Key Points: 
  • MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.
  • Research and development expenses were $7.6 million in the second quarter of 2023, compared to $6.6 million for the same period in 2022.
  • General and administrative expenses were $9.2 million in the second quarter of 2023, compared to $5.3 million for the same period in 2022.
  • As of June 30, 2023, Galera had cash, cash equivalents and short-term investments of $38.8 million.

Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese

Retrieved on: 
Wednesday, August 9, 2023
Workforce, Pancreatic cancer, SBRT, Therapy, Symantec Endpoint Protection, Survival, Clinical trial, NDA, Cancer, Head, Mucositis, Lung cancer, SOM, Radiation, GRECO, Patient, Diagnosis, CRL, FDA, Galera, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.

Key Points: 
  • The Company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem.
  • “This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” said Mel Sorensen, M.D., Galera’s President and CEO.
  • The Company will focus resources to define the path forward for avasopasem and to progress the ongoing clinical trials for rucosopasem.
  • The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.

Galera Reports Third Quarter 2021 Financial Results and Recent Corporate Updates

Retrieved on: 
Wednesday, November 10, 2021
Safety, Cancer, Lung cancer, Progression-free survival, SBRT, Esophagitis, Private Securities Litigation Reform Act, Therapy, Privacy, Neoplasm, SOM, U.S. Securities and Exchange Commission, Radiation, Health, Ownership, CEO, Technology, Failure, GRECO, Insurance, Investment, GC4419, COVID-19, Annual report, Incidence, HNC, Company, Research, GLOBE, Large-cell lung carcinoma, AESOP, NSCLC, SEC, Fast track (FDA), LAPC, Lung, Pancreatic cancer, Survival, Nasdaq, Patient, Head, Pharmaceutical industry, Medical imaging, Air cargo

MALVERN, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2021 and provided recent corporate updates.

Key Points: 
  • Dr. Sorensen continued: Following the recent announcement of topline results of the Phase 3 ROMAN trial, we are continuing to analyze the data and evaluating next steps for avasopasem.
  • Research and development expenses were $14.8 million in the third quarter of 2021, compared to $12.1 million for the same period in 2020.
  • General and administrative expenses were $5.5 million in the third quarter of 2021, compared to $3.9 million for the same period in 2020.
  • As of September 30, 2021, Galera had cash, cash equivalents and short-term investments of $88.7 million.

Taiwan Plastics Industry Association's new chairman Benker Liao works with industry players to transform the plastics industry

Retrieved on: 
Tuesday, November 2, 2021
Statistics, PU, Elasticity, HIPS, EPS, Research, OPS, Recycling, Technology, Trade, EPP, Industry, Association, Pollution, Carbon, GRECO, Plastics Industry Association (PLASTICS), PET, PSP, Liao, Electronics, DIN, PP, Leadership, First Nations in Ontario, Color, BPI, EPDM, FAP, Rubber industry in Malaysia, TPU, CEO, Infrared, SCI, Traction, D, Paper, PUR, Plastic, IBI

TAIPEI, Nov. 2, 2021 /PRNewswire/ -- The Taiwan Plastics Industry Association elected Benker Liao, CEO of Benison & Co., as its new chairman onOctober 16.

Key Points: 
  • TAIPEI, Nov. 2, 2021 /PRNewswire/ -- The Taiwan Plastics Industry Association elected Benker Liao, CEO of Benison & Co., as its new chairman onOctober 16.
  • However, in order to address issues including environmental sustainability globally and talent shortages that challenge the future development of the island's plastics industry, the industry is actively undertaking a sector-wide transformation.
  • Taiwan's plastics industry, under the leadership of the Taiwan Plastics Industry Association, is entering higher-end niche markets, in line with the trend of providing high-value and environmentally responsible manufacturing.
  • The Taiwan Plastics Industry Association stressed that the plastics industry must move toward high-value and value-added materials.