Galera

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
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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
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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
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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
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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 First Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Thursday, May 11, 2023
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MALVERN, Pa., May 11, 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 first quarter ended March 31, 2023, and provided recent corporate updates.

Key Points: 
  • With Priority Review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA is August 9, 2023.
  • Research and development expenses were $7.3 million in the first quarter of 2023, compared to $8.1 million for the same period in 2022.
  • As of March 31, 2023, Galera had cash, cash equivalents and short-term investments of $47.8 million.
  • Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.

Galera Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, May 4, 2023
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These stock options are subject to the terms of the Galera Therapeutics, Inc. 2023 Employment Inducement Award Plan (the “Inducement Plan”).

Key Points: 
  • These stock options are subject to the terms of the Galera Therapeutics, Inc. 2023 Employment Inducement Award Plan (the “Inducement Plan”).
  • The Inducement Plan is used exclusively for the grant of equity awards to individuals as an inducement material to their entering into employment with Galera pursuant to Nasdaq Listing Rule 5635(c)(4).
  • The Inducement Plan was adopted by Galera’s board of directors in April 2023.
  • The stock options have an exercise price of $2.955 per share.

Galera Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and Warrants

Retrieved on: 
Wednesday, February 15, 2023
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The warrants have an exercise price of $1.97 per share of common stock.

Key Points: 
  • The warrants have an exercise price of $1.97 per share of common stock.
  • The gross proceeds of the offering are expected to be approximately $30 million, before placement agent fees and offering expenses.
  • All shares of common stock and warrants to purchase common stock to be sold in the offering will be sold by Galera.
  • The warrants will be exercisable immediately following their issuance and will expire five years from the date of issuance.

Galera to Present at Piper Sandler Annual Healthcare Conference

Retrieved on: 
Tuesday, November 22, 2022
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MALVERN, Pa., Nov. 22, 2022 (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 Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.

Key Points: 
  • MALVERN, Pa., Nov. 22, 2022 (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 Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.
  • A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com .

Galera to Participate in the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Tuesday, September 6, 2022
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A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .

Key Points: 
  • A live webcast of the presentation will be accessible from the Investors page of Galeras website, investors.galeratx.com .
  • An archived version of the webcast will be available in the Events & Presentations section of the Investors page of Galeras website for 30 days following the event.
  • Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
  • Galeras selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities.