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Galera Therapeutics
10-Q 2020-06-30 Filed 2020-08-10
10-Q 2020-03-31 Filed 2020-05-12
10-K 2019-12-31 Filed 2020-03-10
S-1 2019-10-11 Public Filing
10-Q 2019-09-30 Filed 2019-12-10
8-K 2020-09-09 Regulation FD, Exhibits
8-K 2020-08-10 Earnings, Exhibits
8-K 2020-07-14 Regulation FD, Exhibits
8-K 2020-06-09
8-K 2020-05-12
8-K 2020-05-11
8-K 2020-03-31
8-K 2020-03-10
8-K 2019-12-10
8-K 2019-11-12

GRTX 10Q Quarterly Report

Part I - Financial Information
Item 1. Financial Statements.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Item 4. Controls and Procedures.
Part II - Other Information
Item 1. Legal Proceedings.
Item 1A. Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Item 3. Defaults Upon Senior Securities.
Item 4. Mine Safety Disclosures.
Item 5. Other Information.
Item 6. Exhibits.
EX-31.1 grtx-ex311_9.htm
EX-31.2 grtx-ex312_8.htm
EX-32.1 grtx-ex321_6.htm
EX-32.2 grtx-ex322_7.htm

Galera Therapeutics Earnings 2019-09-30

Balance SheetIncome StatementCash Flow

10-Q 1 grtx-10q_20190930.htm 10-Q grtx-10q_20190930.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2019

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to _______

Commission File Number: 001-39114

 

Galera Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

46-1454898

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

2 W Liberty Blvd #100

Malvern, Pennsylvania 

19355

(Address of principal executive offices)

(Zip Code)

 

(610) 725-1500

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

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 Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

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. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

As of December 9, 2019, the registrant had 24,807,789 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

3

 

Consolidated Balance Sheets

3

 

Consolidated Statements of Operations

4

 

Consolidated Statements of Comprehensive Loss

5

 

Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Deficit

6

 

Consolidated Statements of Cash Flows

7

 

Notes to Unaudited Interim Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

18

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

26

Item 4.

Controls and Procedures

26

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

28

Item 1A.

Risk Factors

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

73

Item 3.

Defaults Upon Senior Securities

73

Item 4.

Mine Safety Disclosures

73

Item 5.

Other Information

74

Item 6.

Exhibits

75

Signatures

76

 

 

 

i


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Quarterly Report, including without limitation statements regarding our plans to develop and commercialize our product candidates, the timing of our ongoing or planned clinical trials, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the willingness of healthcare professionals to use our product candidates, the sufficiency of our cash, cash equivalents and short-term investments, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements.

The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We intend the forward-looking statements contained in this Quarterly Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

 

ii


 

 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

GALERA THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS EXCEPT SHARE AND PER-SHARE AMOUNTS)

(unaudited)

 

 

 

September 30,

2019

 

 

December 31,

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

15,719

 

 

$

14,811

 

Short-term investments

 

 

52,226

 

 

 

66,706

 

Tax incentive receivable

 

 

 

 

 

870

 

Prepaid expenses and other current assets

 

 

4,197

 

 

 

1,465

 

Total current assets

 

 

72,142

 

 

 

83,852

 

Property and equipment, net

 

 

970

 

 

 

568

 

Acquired intangible asset

 

 

2,258

 

 

 

2,258

 

Goodwill

 

 

881

 

 

 

881

 

Deferred offering costs

 

 

2,103

 

 

 

 

Right-of-use lease asset

 

 

876

 

 

 

 

Other assets

 

 

528

 

 

 

497

 

Total assets

 

$

79,758

 

 

$

88,056

 

Liabilities, redeemable convertible preferred stock and stockholders’ deficit

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,218

 

 

$

3,867

 

Accrued expenses

 

 

3,574

 

 

 

2,577

 

Lease liability

 

 

291

 

 

 

 

Total current liabilities

 

 

9,083

 

 

 

6,444

 

Royalty purchase liability

 

 

42,313

 

 

 

20,220

 

Deferred rent

 

 

 

 

 

12

 

Lease liability, net of current portion

 

 

604

 

 

 

 

Deferred tax liability

 

 

298

 

 

 

298

 

Total liabilities

 

 

52,298

 

 

 

26,974

 

Redeemable convertible preferred stock, $0.001 par value: 96,385,795 shares authorized,

   issued and outstanding at September 30, 2019 and December 31, 2018, respectively

   (liquidation value of $174,746 at September 30, 2019)

 

 

172,080

 

 

 

165,902

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value: 10,000,000 shares authorized; no shares issued and

   outstanding.

 

 

 

 

 

 

Common stock, $0.001 par value: 200,000,000 shares authorized; 300,597 shares

   issued and outstanding at September 30, 2019 and December 31, 2018

 

 

 

 

 

 

Accumulated other comprehensive income

 

 

55

 

 

 

3

 

Accumulated deficit

 

 

(144,675

)

 

 

(104,823

)

Total stockholders’ deficit

 

 

(144,620

)

 

 

(104,820

)

Total liabilities, redeemable convertible preferred stock and stockholders’ deficit

 

$

79,758

 

 

$

88,056

 

 

See accompanying notes to unaudited interim consolidated financial statements.

3


 

GALERA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS EXCEPT SHARE AND PER SHARE AMOUNTS)

(unaudited)

 

 

 

Three months ended

September 30,

 

 

Nine months ended

September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

11,040

 

 

$

4,162

 

 

$

29,057

 

 

$

11,551

 

General and administrative

 

 

1,816

 

 

 

1,245

 

 

 

5,466

 

 

 

3,846

 

Loss from operations

 

 

(12,856

)

 

 

(5,407

)

 

 

(34,523

)

 

 

(15,397

)

Other income (expenses):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

426

 

 

 

117

 

 

 

1,397

 

 

 

170

 

Interest expense

 

 

(918

)

 

 

 

 

 

(2,094

)

 

 

 

Foreign currency loss

 

 

(3

)

 

 

(11

)

 

 

(38

)

 

 

(27

)

Loss before income tax benefit

 

 

(13,351

)

 

 

(5,301

)

 

 

(35,258

)

 

 

(15,254

)

Income tax benefit

 

 

 

 

 

52

 

 

 

 

 

 

141

 

Net loss

 

 

(13,351

)

 

 

(5,249

)

 

 

(35,258

)

 

 

(15,113

)

Accretion of redeemable convertible preferred stock to redemption

   value

 

 

(2,108

)

 

 

(1,468

)

 

 

(6,178

)

 

 

(3,879

)

Net loss attributable to common stockholders

 

$

(15,459

)

 

$

(6,717

)

 

$

(41,436

)

 

$

(18,992

)

Net loss per share of common stock, basic and diluted

 

$

(51.43

)

 

$

(22.35

)

 

$

(137.85

)

 

$

(63.18

)

Weighted-average shares of common stock outstanding, basic and

   diluted

 

 

300,597

 

 

 

300,597

 

 

 

300,597

 

 

 

300,597

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to unaudited interim consolidated financial statements.

4


 

GALERA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(IN THOUSANDS)

(unaudited)

 

 

 

Three months ended

September 30,

 

 

Nine months ended

September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net loss

 

$

(13,351

)

 

$

(5,249

)

 

$

(35,258

)

 

$

(15,113

)

Unrealized gain on short-term investments

 

 

(26

)

 

 

 

 

 

52

 

 

 

3

 

Comprehensive loss

 

$

(13,377

)

 

$

(5,249

)

 

$

(35,206

)

 

$

(15,110

)

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to unaudited interim consolidated financial statements.

5


 

GALERA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND

STOCKHOLDERS’ DEFICIT

(IN THOUSANDS EXCEPT SHARE AMOUNTS)

(unaudited)

 

 

 

Redeemable convertible

preferred stock

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

(loss) income

 

 

Deficit

 

 

Deficit

 

Balance at January 1, 2018

 

 

64,689,359

 

 

$

90,148

 

 

 

 

300,597

 

 

$

 

 

$

 

 

$

(3

)

 

$

(76,102

)

 

$

(76,105

)

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

208

 

 

 

 

 

 

 

 

 

208

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

1,205

 

 

 

 

 

 

 

 

 

 

(208

)

 

 

 

 

 

(997

)

 

 

(1,205

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,533

)

 

 

(5,533

)

Balance at March 31, 2018

 

 

64,689,359

 

 

 

91,353

 

 

 

 

300,597

 

 

 

 

 

 

 

 

 

 

 

 

(82,632

)

 

 

(82,632

)

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

226

 

 

 

 

 

 

 

 

 

226

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

1,206

 

 

 

 

 

 

 

 

 

 

(226

)

 

 

 

 

 

(980

)

 

 

(1,206

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,331

)

 

 

(4,331

)

Balance at June 30, 2018

 

 

64,689,359

 

 

 

92,559

 

 

 

 

300,597

 

 

 

 

 

 

 

 

 

 

 

 

(87,943

)

 

 

(87,943

)

Sale of Series C redeemable

   convertible preferred stock,

   net of issuance costs

 

 

31,696,436

 

 

 

69,850

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

220

 

 

 

 

 

 

 

 

 

220

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

1,468

 

 

 

 

 

 

 

 

 

 

(220

)

 

 

 

 

 

(1,248

)

 

 

(1,468

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,249

)

 

 

(5,249

)

Balance at September 30, 2018

 

 

96,385,795

 

 

$

163,877

 

 

 

 

300,597

 

 

$

 

 

$

 

 

$

 

 

$

(94,440

)

 

$

(94,440

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable convertible

preferred stock

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income

 

 

Deficit

 

 

Deficit

 

Balance at January 1, 2019

 

 

96,385,795

 

 

$

165,902

 

 

 

 

300,597

 

 

$

 

 

$

 

 

$

3

 

 

$

(104,823

)

 

$

(104,820

)

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

499

 

 

 

 

 

 

 

 

 

499

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

2,011

 

 

 

 

 

 

 

 

 

 

(499

)

 

 

 

 

 

(1,512

)

 

 

(2,011

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

10

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,901

)

 

 

(9,901

)

Balance at March 31, 2019

 

 

96,385,795

 

 

 

167,913

 

 

 

 

300,597

 

 

 

 

 

 

 

 

 

13

 

 

 

(116,236

)

 

 

(116,223

)

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

565

 

 

 

 

 

 

 

 

 

565

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

2,060

 

 

 

 

 

 

 

 

 

 

(565

)

 

 

 

 

 

(1,495

)

 

 

(2,060

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

68

 

 

 

 

 

 

68

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,006

)

 

 

(12,006

)

Balance at June 30, 2019

 

 

96,385,795

 

 

 

169,973

 

 

 

 

300,597

 

 

 

 

 

 

 

 

 

81

 

 

 

(129,737

)

 

 

(129,656

)

Share-based compensation

   expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

520

 

 

 

 

 

 

 

 

 

520

 

Accretion of redeemable

   convertible preferred stock

   to redemption value

 

 

 

 

 

2,107

 

 

 

 

 

 

 

 

 

 

(520

)

 

 

 

 

 

(1,587

)

 

 

(2,107

)

Unrealized gain on short-term

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26

)

 

 

 

 

 

(26

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,351

)

 

 

(13,351

)

Balance at September 30, 2019

 

 

96,385,795

 

 

$

172,080

 

 

 

 

300,597

 

 

$

 

 

$

 

 

$

55

 

 

$

(144,675

)

 

$

(144,620

)

 

See accompanying notes to unaudited interim consolidated financial statements.

6


 

GALERA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(unaudited)

 

 

 

Nine months ended

September 30,

 

 

 

2019

 

 

2018

 

Operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(35,258

)

 

$

(15,113

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation

 

 

188

 

 

 

86

 

Noncash interest expense

 

 

2,094

 

 

 

 

Share-based compensation expense

 

 

1,584

 

 

 

654

 

Reserve for tax incentive receivable

 

 

241

 

 

 

 

Deferred tax liability

 

 

 

 

 

(141

)

Deferred rent

 

 

7

 

 

 

(1

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Tax incentive receivable

 

 

629

 

 

 

(149

)

Prepaid expenses and other current assets

 

 

(2,732

)

 

 

(168

)

Other assets

 

 

(31

)

 

 

(255

)

Accounts payable

 

 

1,131

 

 

 

(308

)

Accrued expense

 

 

762

 

 

 

(153

)

Cash used in operating activities

 

 

(31,385

)

 

 

(15,548

)

Investing activities:

 

 

 

 

 

 

 

 

Purchases of short-term investments

 

 

(63,468

)

 

 

(16,406

)

Proceeds from sales of short-term investments

 

 

78,000

 

 

 

9,000

 

Purchase of property and equipment

 

 

(567

)

 

 

(48

)

Cash provided by (used in) investing activities

 

 

13,965

 

 

 

(7,454

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from royalty purchase agreement

 

 

20,000

 

 

 

 

Proceeds from the sale of Series C redeemable convertible preferred stock, net of

     issuance costs

 

 

 

 

 

69,850

 

Payment of deferred offering costs

 

 

(1,672

)

 

 

 

Cash provided by financing activities

 

 

18,328

 

 

 

69,850

 

Net increase in cash and cash equivalents

 

 

908

 

 

 

46,848

 

Cash and cash equivalents at beginning of period

 

 

14,811

 

 

 

6,169

 

Cash and cash equivalents at end of period

 

$

15,719

 

 

$

53,017

 

Supplemental schedule of non-cash financing activities:

 

 

 

 

 

 

 

 

Accretion of redeemable convertible preferred stock to redemption value

 

$

6,178

 

 

$

3,879

 

Deferred offering costs included in accounts payable and accrued expenses

 

$

431

 

 

$

 

Purchase of property and equipment included in accounts payable and accrued expenses

 

$

24

 

 

$

268

 

Initial recognition of operating lease right-of-use asset and operating lease liability

 

$

1,084

 

 

$

 

 

 

 

 

 

 

 

 

See accompanying notes to unaudited interim consolidated financial statements.

 

7


 

GALERA THERAPEUTICS, INC.

NOTES TO UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

1.

Organization and description of business

Galera Therapeutics, Inc. was incorporated as a Delaware corporation on November 19, 2012 (inception) and together with its subsidiaries, (the Company, or Galera) is 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. The Company’s lead product candidate, GC4419, is a potent and highly selective small molecule dismutase mimetic being developed for the reduction of severe oral mucositis (SOM). In February 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiotherapy with or without systemic therapy. The Company is currently evaluating GC4419 in a Phase 3 registrational trial. In addition to developing GC4419 for the reduction of normal tissue toxicity from radiotherapy, the Company is developing its dismutase mimetics to increase the anti-cancer efficacy of higher daily doses of radiotherapy, including stereotactic body radiation therapy (SBRT). The Company’s second dismutase mimetic product candidate, GC4711, is being developed to increase the anti-cancer efficacy of SBRT and has successfully completed a Phase 1 trial of intravenous GC4711 in healthy volunteers. The Company plans to leverage its observations from the GC4419 SBRT pilot Phase 1b/2a trial in locally advanced pancreatic cancer (LAPC) to prepare a GC4711 SBRT combination Phase 1b/2a trial in non-small cell lung cancer (NSCLC).

Reverse Stock Split

The Company effected a one-for-5.056564 reverse stock split of its common stock on October 25, 2019. The reverse stock split combined each approximately five shares of the Company’s issued and outstanding common stock into one share of common stock and correspondingly adjusted the conversion price of its redeemable convertible preferred stock. No fractional shares were issued in connection with the reverse stock split. Any fractional share resulting from the reverse stock split was rounded down to the nearest whole share, and in lieu of any fractional shares, the Company will pay in cash to the holders of such fractional shares an amount equal to the fair value, as determined by the board of directors, of such fractional shares. All common stock, per share and related information presented in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse stock split.

Liquidity

The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $144.7 million as of September 30, 2019. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its product candidates currently in development.

On November 12, 2019, the Company completed an initial public offering (IPO) of its common stock, which resulted in the issuance and sale of 5,000,000 shares of its common stock at a public offering price of $12.00 per share, generating net proceeds of $53.1 million after deducting underwriting discounts and other offering costs. On December 9, 2019, in connection with the partial exercise of the over-allotment option granted to the underwriters of the Company's IPO, 445,690 additional shares of common stock were sold at the IPO price of $12.00 per share, generating net proceeds of approximately $5.0 million after deducting underwriting discounts and other offering costs. Upon the closing of the IPO, all outstanding shares of the Company’s Series A, Series B and Series C redeemable convertible preferred stock were automatically converted into 19,061,502 shares of the Company’s common stock. In addition, upon the closing of the IPO, the Company’s amended and restated certificate of incorporation authorized the Company to issue up to 200,000,000 shares of common stock, $0.001 par value per share, and 10,000,000 shares of preferred stock, $0.001 par value per share, all of which shares of preferred stock will be undesignated.

2.

Basis of presentation and significant accounting policies

The summary of significant accounting policies disclosed in the Company’s annual consolidated financial statements for the years ended December 31, 2018 and 2017 included in the Company’s final prospectus dated November 6, 2019 and filed with the Securities and Exchange Commission (SEC) on November 8, 2019 pursuant to Rule 424(b)(4) have not materially changed, except as set forth below.

Basis o