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GALERA THERAPEUTICS INC - GRTX STOCK NEWS

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Galera Therapeutics, Inc. (Nasdaq: GRTX), headquartered in Malvern, Pennsylvania, is a clinical-stage biopharmaceutical company dedicated to transforming radiotherapy in cancer through innovative therapeutics. The company is currently focused on the development and commercialization of two primary product candidates: avasopasem manganese (avasopasem) and rucosopasem manganese (rucosopasem).

Avasopasem, a selective dismutase mimetic, has been developed to reduce radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer. Despite receiving Fast Track and Breakthrough Therapy designations from the FDA, the company's New Drug Application (NDA) for avasopasem was met with a Complete Response Letter, requiring additional clinical trials for resubmission.

Rucosopasem aims to enhance the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Though rucosopasem has been granted orphan drug designation by the FDA, the company recently made the difficult decision to halt the Phase 2b GRECO-2 trial and the Phase 1/2 GRECO-1 trial due to a futility analysis of the GRECO-2 trial.

Following these setbacks, Galera has taken decisive steps to extend its cash runway, including workforce reductions and shifting focus towards strategic alternatives such as partnerships, mergers, and asset sales. As of the latest financial updates, the company estimates its balance of cash, cash equivalents, and marketable securities to support operations into the second quarter of 2024. Galera is actively evaluating these strategic options to maximize shareholder value while continuing its mission to improve cancer treatment outcomes.

For more information, visit the Investors page of Galera’s website.

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Galera Therapeutics (Nasdaq: GRTX) announced its Board's approval of a Plan of Liquidation and Dissolution, seeking stockholder approval on October 17, 2024. If approved, the company will file for dissolution with Delaware and distribute remaining cash to stockholders after settling liabilities. This decision follows a year-long review of strategic alternatives to maximize stockholder value. Galera will reduce its workforce to three employees by August 31, 2024, with the CEO continuing through the transition.

In Q2 2024, Galera reported:

  • Research and development expenses: $1.4 million (down from $7.6 million in Q2 2023)
  • General and administrative expenses: $2.8 million (down from $9.2 million in Q2 2023)
  • Net loss: $(4.1) million, or $(0.07) per share
  • Cash and cash equivalents: $10.7 million as of June 30, 2024
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Galera Therapeutics, Inc. (Nasdaq: GRTX) reported financial results for Q1 2024, highlighting a net loss decrease compared to 2023. The company is exploring strategic alternatives to maximize shareholder value, potentially leading to dissolution. The Board adopted a Rights Agreement to protect stockholder interests. Galera had $13.5 million in cash as of March 31, 2024, expected to fund operations into Q3 2025.

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Galera Therapeutics, Inc. adopts a duration stockholder rights agreement to protect stockholder interests in response to recent accumulations of the company's common stock. The agreement aims to enable all stockholders to realize the full potential value of their investment, reduce the likelihood of a person or group gaining control without paying an appropriate premium, and provide the Board with time to make informed decisions. The Rights Agreement will issue preferred share purchase rights to stockholders, with an expiration date of May 2, 2025. The agreement becomes exercisable if an acquiring person obtains ten percent or more of the company's common stock in an unapproved transaction.

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Galera Therapeutics, Inc. (Nasdaq: GRTX) announced financial results for Q4 and year 2023, focusing on avasopasem and rucosopasem development. The company is evaluating strategic options to maximize shareholder value, including potential dissolution. Recent updates include workforce reduction, engagement of financial advisor, and FDA interactions. Financially, R&D expenses decreased, net loss improved, and cash reserves support operations into Q2 2025.
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Galera Therapeutics, Inc. (Nasdaq: GRTX) announced the need for a new trial for avasopasem, leading to the discontinuation of GRECO trials with rucosopasem. They are exploring strategic options to maximize shareholder value.
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Galera Therapeutics, Inc. will need to conduct a new Phase 3 trial for avasopasem for radiotherapy-induced severe oral mucositis (SOM) as the previous trials did not meet FDA requirements. The company has decided to discontinue both the Phase 2b GRECO-2 trial for rucosopasem in pancreatic cancer and the Phase 1/2 GRECO-1 trial for rucosopasem in lung cancer. Galera is exploring strategic alternatives to maximize shareholder value. The company's cash balance as of September 30, 2023, was $28.4 million.
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Galera Therapeutics schedules Type A Meeting with FDA regarding Complete Response Letter for avasopasem manganese
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Galera Therapeutics CEO to participate in fireside chat at H.C. Wainwright Conference
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Galera Therapeutics, Inc. received a Complete Response Letter from the FDA for avasopasem, but intends to request a Type A meeting to discuss potential next steps. The company's cash runway has been extended into Q2 2024. Enrollment in GRECO trials with rucosopasem is ongoing. FDA granted orphan drug designation to rucosopasem for pancreatic cancer.
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Galera Therapeutics receives Complete Response Letter from FDA regarding avasopasem NDA
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FAQ

What is the current stock price of GALERA THERAPEUTICS (GRTX)?

The current stock price of GALERA THERAPEUTICS (GRTX) is $0.031 as of December 23, 2024.

What is the market cap of GALERA THERAPEUTICS (GRTX)?

The market cap of GALERA THERAPEUTICS (GRTX) is approximately 6.5M.

What is Galera Therapeutics' primary focus?

Galera Therapeutics is focused on developing and commercializing novel therapeutics to improve the efficacy and reduce the side effects of radiotherapy in cancer patients.

What are the main product candidates of Galera Therapeutics?

The main product candidates are avasopasem manganese (avasopasem) and rucosopasem manganese (rucosopasem).

What is avasopasem developed for?

Avasopasem is developed to reduce radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer.

Why did the FDA issue a Complete Response Letter for avasopasem?

The FDA issued a Complete Response Letter indicating that additional clinical trials are required to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis.

What designation has the FDA granted to avasopasem?

Avasopasem has received Fast Track and Breakthrough Therapy designations from the FDA.

What is rucosopasem developed to do?

Rucosopasem is developed to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer and locally advanced pancreatic cancer.

Why were the GRECO trials for rucosopasem halted?

The GRECO trials were halted following a futility analysis that indicated the trial was unlikely to succeed as designed.

What strategic steps is Galera Therapeutics taking following recent setbacks?

Galera is exploring strategic alternatives including partnerships, mergers, and asset sales to maximize shareholder value.

What is the current financial outlook for Galera Therapeutics?

As of the most recent update, Galera estimates its cash and equivalents will support operations into the second quarter of 2024.

Where is Galera Therapeutics headquartered?

Galera Therapeutics is headquartered in Malvern, Pennsylvania, USA.

GALERA THERAPEUTICS INC

Nasdaq:GRTX

GRTX Rankings

GRTX Stock Data

6.52M
37.19M
31.63%
0.98%
3.9%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
MALVERN