8-K
false 0001563577 0001563577 2022-08-09 2022-08-09

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): August 9, 2022

 

 

GALERA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39114   46-1454898

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

2 W Liberty Blvd #100

Malvern, PA 19355

(Address of principal executive offices) (Zip Code)

(610) 725-1500

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value per share   GRTX  

The Nasdaq Stock Market LLC

(Nasdaq Global Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On August 9, 2022, Galera Therapeutics, Inc. announced its financial results for the quarter ended June 30, 2022. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

Exhibit 99.1 relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

Exhibit
No.

  

Description

99.1    Press Release of Galera Therapeutics, Inc. issued August 9, 2022
104    Cover Page Interactive Data File (embedded within the inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    GALERA THERAPEUTICS, INC.
Date: August 9, 2022     By:  

/s/ J. Mel Sorensen, M.D.

      J. Mel Sorensen, M.D.
      President and Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

Galera Reports Second Quarter 2022 Financial Results and Recent Corporate Updates

Company on track to submit NDA to U.S. FDA for avasopasem by end of 2022

Phase 3 ROMAN trial data highlighted in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Phase 1 stage of GRECO-1 trial demonstrated rucosopasem in combination with SBRT was well tolerated with early indications of anti-cancer activity

Completion of enrollment in both GRECO-1 and GRECO-2 trials of rucosopasem in combination with SBRT expected in 2H 2023

MALVERN, Pa. – August 9, 2022 – 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, 2022 and provided recent corporate updates.

“During this past quarter, we made substantial progress in advancing our product candidates, avasopasem and rucosopasem, across all programs,” said Mel Sorensen, M.D., Galera’s President and CEO. “We continue to prepare for submission of an NDA for avasopasem for the treatment of radiotherapy-induced SOM and are on track to submit it by the end of the year. Further, data from our Phase 3 ROMAN trial were presented at multiple prestigious medical conferences, including ASCO, underscoring the significant unmet need for an FDA-approved treatment option for radiotherapy-induced SOM in patients with head and neck cancer. In addition, we recently announced data from the open-label Phase 1 stage of GRECO-1 investigating rucosopasem in combination with SBRT in patients with NSCLC and are pleased to report that rucosopasem seems to exhibit a favorable benefit-risk profile, with in-field partial responses or stable disease seen in six of the seven patients at six months follow-up.”


Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

 

   

The Company remains on track to submit a New Drug Application (NDA) for avasopasem for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.

 

   

An oral presentation on Phase 3 ROMAN data of avasopasem for SOM was given at the 2022 ASCO Annual Meeting. Avasopasem produced a clinically meaningful reduction in patients’ SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Avasopasem also appeared to be well tolerated compared to placebo.

 

   

Data from the Phase 3 ROMAN trial of avasopasem for SOM was presented at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) Annual Meeting in June 2022.

Esophagitis

 

   

The Company reported positive topline data from the open-label, single-arm Phase 2a AESOP trial of avasopasem for the treatment of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to expectations based on review of historical data in the literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.

Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

 

   

A Trials in Progress poster on the Phase 2b GRECO-2 trial was presented at the 2022 ASCO Annual Meeting.

 

   

Enrollment is ongoing in the Phase 2b GRECO-2 trial of rucosopasem in combination with SBRT in patients with LAPC. The primary endpoint of the trial is overall survival. Completion of enrollment is expected in the second half of 2023.

Non-Small Cell Lung Cancer (NSCLC)

 

   

The Company recently reported results from the open-label, seven-patient Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Through six months follow-up, in-field partial responses were observed in three patients and stable disease was observed in three others based on RECIST criteria. These include target tumor reductions in five patients of 61%, 58%, 33%, 29% and 27% and one patient with an 8% increase. Preservation of pulmonary lung function was also observed in comparison to expectations based on review of historical data in the literature. Completion of enrollment in the randomized, placebo-controlled Phase 2 stage of this trial is expected in the second half of 2023.


Second Quarter 2022 Financial Highlights

 

   

Research and development expenses were $6.7 million in the second quarter of 2022, compared to $16.0 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.

 

   

General and administrative expenses were $5.3 million in the second quarter of 2022, broadly consistent with the second quarter of 2021.

 

   

Galera reported a net loss of $(14.6) million, or $(0.54) per share, for the second quarter of 2022, compared to a net loss of $(22.4) million, or $(0.88) per share, for the same period in 2021.

 

   

As of June 30, 2022, Galera had cash, cash equivalents and short-term investments of $52.0 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 for at least the next twelve months.

About Galera Therapeutics

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’s selective dismutase mimetic product candidate avasopasem manganese (GC4419, also referred to as avasopasem) is being evaluated for radiotherapy-induced toxicities. The Company’s second product candidate, rucosopasem manganese (GC4711, also referred to as rucosopasem), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: the expectations surrounding the continued advancement of Galera’s product pipeline; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; the timing of the submission of an NDA for avasopasem for the treatment of radiotherapy-induced SOM in patients with locally advanced head and neck cancer with the FDA; the expectations surrounding the progress of the Phase 2b trial of rucosopasem in patients with LAPC and the timing of completion of enrollment of the trial; the expectations surrounding the progress of the Phase 1/2 trial of rucosopasem in patients with NSCLC and the timing of completion of enrollment of the trial; the Company’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics; the potential of GC4711 to augment the anti-cancer efficacy of SBRT in patients with NSCLC and LAPC; and the Company’s ability to fund its operating expenses and capital expenditure requirements for at least the next twelve months. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or


delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside the United States; undesirable side effects from Galera’s product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera’s reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera’s business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera’s common stock; the possibility of Galera’s common stock being delisted from The Nasdaq Global Market; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in Galera’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and Galera’s other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Galera Therapeutics Inc.

Consolidated Statements of Operations

(unaudited, in thousands except share and per share data)

 

     Three Months Ended June 30,      Six Months Ended June 30,  
     2022      2021      2022      2021  

Operating expenses:

           

Research and development

   $ 6,662      $ 15,966      $ 14,769      $ 28,389  

General and administrative

     5,293        5,122        10,340        10,180  
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss from operations

     (11,955      (21,088      (25,109      (38,569

Other income (expense), net

     (2,603      (1,298      (4,892      (2,532
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (14,558    $ (22,386    $ (30,001    $ (41,101
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss per share of common stock, basic and diluted

   $ (0.54    $ (0.88    $ (1.12    $ (1.63
  

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average common shares outstanding, basic and diluted

     26,821,303        25,401,046        26,785,540        25,195,763  
  

 

 

    

 

 

    

 

 

    

 

 

 

Galera Therapeutics, Inc.

Selected Consolidated Balance Sheet Data

(unaudited, in thousands)

 

     June 30,
2022
     December 31,
2021
 

Cash, cash equivalents, and short-term investments

   $ 52,007      $ 71,217  

Total assets

     61,078        83,311  

Total current liabilities

     10,986        12,935  

Total liabilities

     144,324        141,315  

Total stockholders’ deficit

     (83,246      (58,004

###


Investor Contacts:

Christopher Degnan

Galera Therapeutics, Inc.

610-725-1500

cdegnan@galeratx.com

William Windham

Solebury Trout

646-378-2946

wwindham@soleburytrout.com

Media Contact:

Zara Lockshin

Solebury Trout

330-417-6250

zlockshin@soleburytrout.com