UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

 

For the month of November 2019

 

Commission File Number: 001-36622

 

PROQR THERAPEUTICS N.V.

 

Zernikedreef 9

2333 CK Leiden

The Netherlands

Tel: +31 88 166 7000

(Address, Including ZIP Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  o

 

 

 


 

Furnished as Exhibit 99.1 to this Report on Form 6-K are the unaudited financial statements of ProQR Therapeutics N.V. (the “Company”) for the three and nine month periods ended September 30, 2019, and furnished as Exhibit 99.2 to this Report on Form 6-K is a press release of the Company, dated November 6, 2019, announcing the Company’s results for the three and nine month periods ended September 30, 2019.

 

The Company hereby incorporates by reference the information contained herein into the Company’s registration statement on Form F-3 (File No. 333-228251).

 

2


 

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, thereunto duly authorized.

 

 

PROQR THERAPEUTICS N.V.

 

 

 

 

 

 

Date: November 12, 2019

By:

/s/ Smital Shah

 

 

Smital Shah

 

 

Chief Financial Officer

 

3


 

INDEX TO EXHIBITS

 

Number

 

Description

 

 

 

99.1

 

Unaudited financial statements of ProQR Therapeutics N.V. for the three and nine month periods ended September 30, 2019.

 

 

 

99.2

 

Press Release of ProQR Therapeutics N.V. dated November 6, 2019, announcing the Company’s results for the three and nine month periods ended September 30, 2019.

 

4


Exhibit 99.1

 

PROQR THERAPEUTICS N.V.
Index to Unaudited Condensed
Consolidated Financial Statements

 

 

PAGE

 

 

Unaudited Condensed Consolidated Statement of Financial Position at September 30, 2019 and December 31, 2018

1

 

 

Unaudited Condensed Consolidated Statement of Comprehensive Loss for the Three Month and Nine Month Periods ended September 30, 2019 and 2018

2

 

 

Unaudited Condensed Consolidated Statement of Changes in Equity for the Nine Month Periods ended September 30, 2019 and 2018

3

 

 

Unaudited Condensed Consolidated Statement of Cash Flows for the Three Month and Nine Month Periods ended September 30, 2019 and 2018

4

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

5

 


 

Unaudited Condensed Consolidated Financial Statements

 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position

 

 

 

September 30, 

 

December 31, 

 

 

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

74,792

 

105,580

 

Prepayments and other receivables

 

2,450

 

1,544

 

Social securities and other taxes

 

830

 

1,243

 

 

 

 

 

 

 

Total current assets

 

78,072

 

108,367

 

 

 

 

 

 

 

Property, plant and equipment

 

2.413

 

1,864

 

Investments in associates

 

579

 

 

 

 

 

 

 

 

Total assets

 

81,064

 

110,231

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

 

Equity

 

 

 

 

 

Equity attributable to owners of the Company

 

59,871

 

92,915

 

Non-controlling interests

 

(452

)

(230

)

Total equity

 

59,419

 

92,685

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Borrowings

 

260

 

 

Lease liabilities

 

890

 

 

Trade payables

 

668

 

135

 

Social securities and other taxes

 

15

 

 

Pension premiums

 

13

 

7

 

Deferred income

 

984

 

545

 

Other current liabilities

 

8,305

 

7,473

 

 

 

 

 

 

 

Total current liabilities

 

11,135

 

8,160

 

 

 

 

 

 

 

Borrowings

 

10,510

 

9,386

 

Lease liabilities

 

 

 

 

 

 

 

 

 

Total liabilities

 

21,645

 

17,546

 

 

 

 

 

 

 

Total equity and liabilities

 

81,064

 

110,231

 

 

The notes are an integral part of these condensed consolidated financial statements.

 

PROQR THERAPEUTICS  |  ZERNIKEDREEF 9  |  2333 CK LEIDEN  |  THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM

 

1


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Profit or Loss and OCI

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

 

 

 

Three month period

 

Nine month period

 

 

 

ended September 30, 

 

ended September 30, 

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Other income

 

530

 

2,958

 

1,509

 

4,428

 

 

 

 

 

 

 

 

 

 

 

Research and development costs

 

(11,074

)

(6,297

)

(32,560

)

(19,972

)

General and administrative costs

 

(2,903

)

(2,579

)

(8,970

)

(7,900

)

 

 

 

 

 

 

 

 

 

 

Total operating costs

 

(13,977

)

(8,876

)

(41,530

)

(27,872

)

 

 

 

 

 

 

 

 

 

 

Operating result

 

(13,447

)

(5,918

)

(40,021

)

(23,444

)

Finance income and expense

 

1,375

 

(74

)

1,339

 

(664

)

Results related to associates

 

(119

)

 

579

 

 

 

 

 

 

 

 

 

 

 

 

Result before corporate income taxes

 

(12,191

)

(5,992

)

(38,103

)

(24,108

)

Income taxes

 

 

 

(64

)

(1

)

 

 

 

 

 

 

 

 

 

 

Result for the period

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

Other comprehensive income

 

147

 

(4

)

121

 

(15

)

 

 

 

 

 

 

 

 

 

 

Total comprehensive income (attributable to owners of the Company)

 

(12,044

)

(5,996

)

(38,046

)

(24,124

)

 

 

 

 

 

 

 

 

 

 

Result attributable to

 

 

 

 

 

 

 

 

 

Owners of the Company

 

(12,139

)

(5,959

)

(37,945

)

(23,974

)

Non-controlling interests

 

(52

)

(33

)

(222

)

(135

)

 

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

 

 

 

 

 

 

 

 

 

 

Share information

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding(1)

 

38,912,701

 

33,355,327

 

38,902,203

 

32,440,220

 

 

 

 

 

 

 

 

 

 

 

Earnings per share attributable to the equity holders of the Company (expressed in Euro per share)

 

 

 

 

 

 

 

 

 

Basic loss per share(1)

 

(0.31

)

(0.18

)

(0.98

)

(0.74

)

Diluted loss per share(1)

 

(0.31

)

(0.18

)

(0.98

)

(0.74

)

 

The notes are an integral part of these condensed consolidated financial statements.

 


(1)         For this period presented in these financial statements, the potential exercise of share options is not included in the diluted earnings per share calculation as the Company was loss-making in all periods. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal in this period.

 

2


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity

 

 

 

Attributable to owners of the Company

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Settled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

 

 

 

 

 

 

Non-

 

 

 

 

 

Number of

 

Share

 

Share

 

Benefit

 

Translation

 

Accumulated

 

 

 

controlling

 

Total

 

 

 

shares

 

Capital

 

Premium

 

Reserve

 

Reserve

 

Deficit

 

Total

 

interests

 

Equity

 

 

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Balance at January 1, 2018

 

36,425,014

 

1,457

 

148,763

 

8,377

 

136

 

(119,370

)

39,363

 

(38

)

39,325

 

Result for the period

 

 

 

 

 

 

(23,974

)

(23,974

)

(135

)

(24,109

)

Other comprehensive income

 

 

 

 

 

(15

)

 

(15

)

 

(15

)

Recognition of share-based payments

 

 

 

 

2,245

 

 

 

2,245

 

 

2,245

 

Issuance of ordinary shares

 

6,612,500

 

265

 

84,032

 

 

 

 

84,297

 

 

84,297

 

Share options exercised

 

 

 

659

 

 

 

 

659

 

 

659

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

43,037,514

 

1,722

 

233,454

 

10,622

 

121

 

(143,344

)

102,575

 

(173

)

102,402

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2019

 

43,149,987

 

1,726

 

235,744

 

10,780

 

108

 

(155,443

)

92,915

 

(230

)

92,685

 

Result for the period

 

 

 

 

 

 

(37,945

)

(37,945

)

(222

)

(38,167

)

Other comprehensive income

 

 

 

 

 

121

 

 

121

 

 

121

 

Recognition of share-based payments

 

 

 

 

4,614

 

 

 

4,614

 

 

4,614

 

Share options lapsed

 

 

 

 

(33

)

 

 

33

 

 

 

 

Share options exercised

 

 

 

166

 

(115

)

 

115

 

166

 

 

166

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2019

 

43,149,987

 

1,726

 

235,910

 

15,246

 

229

 

(193,240

)

59,871

 

(452

)

59,419

 

 

The notes are an integral part of these condensed consolidated financial statements

 

3


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed
Consolidated Statement of Cash Flows

 

 

 

Three month period 

 

Nine month period

 

 

 

ended September 30, 

 

ended September 30, 

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

 

Net result

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

Adjustments for:

 

 

 

 

 

 

 

 

 

— Depreciation

 

506

 

242

 

1,543

 

725

 

— Share-based compensation

 

1,226

 

734

 

4,614

 

2,245

 

— Financial income and expenses

 

(1,375

)

74

 

(1,339

)

664

 

— Results related to associates

 

119

 

 

(579

)

 

— Net foreign exchange gain / (loss)

 

148

 

(4

)

122

 

(15

)

 

 

 

 

 

 

 

 

 

 

Changes in working capital

 

2,718

 

656

 

1,744

 

1,074

 

Cash used in operations

 

(8,849

)

(4,290

)

(32,062

)

(19,416

)

 

 

 

 

 

 

 

 

 

 

Corporate income tax paid

 

 

1

 

(64

)

 

Interest received

 

90

 

32

 

176

 

25

 

Interest paid

 

(13

)

 

(64

)

 

 

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

(8,772

)

(4,257

)

(32,014

)

(19,391

)

 

 

 

 

 

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

 

 

 

 

 

Purchases of intangible assets

 

 

 

 

 

Purchases of property, plant and equipment

 

(32

)

(99

)

(341

)

(285

)

 

 

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

(32

)

(99

)

(341

)

(285

)

 

 

 

 

 

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

 

 

 

 

 

Proceeds from issuance of shares, net of transaction costs

 

 

84,295

 

 

84,295

 

Proceeds from exercise of share options

 

2

 

637

 

166

 

660

 

Proceeds from borrowings

 

 

 

 

101

 

Proceeds from convertible loans

 

 

115

 

690

 

430

 

Repayment of lease liability

 

(290

)

 

(861

)

 

 

 

 

 

 

 

 

 

 

 

Net cash (used in)/generated by financing activities

 

(288

)

85,047

 

(5

)

85,486

 

 

 

 

 

 

 

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

(9,092

)

80,691

 

(32,360

)

65,810

 

 

 

 

 

 

 

 

 

 

 

Currency effect cash and cash equivalents

 

1,420

 

57

 

1,572

 

(193

)

Cash and cash equivalents, at beginning of the period

 

82,464

 

32,968

 

105,580

 

48,099

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

74,792

 

113,716

 

74,792

 

113,716

 

 

The notes are an integral part of these condensed consolidated financial statements.

 

4


 

PROQR THERAPEUTICS N.V.
Notes to Unaudited Condensed
Consolidated Financial Statements

 

1. General information

 

ProQR Therapeutics N.V., or “ProQR” or the “Company”, is a development stage company domiciled in the Netherlands that primarily focuses on the development and commercialization of novel therapeutic medicines.

 

Since September 18, 2014, the Company’s ordinary shares are listed on the NASDAQ Global Market under ticker symbol PRQR.

 

The Company was incorporated in the Netherlands, on February 21, 2012 and was reorganized from a private company with limited liability to a public company with limited liability on September 23, 2014. The Company has its statutory seat in Leiden, the Netherlands. The address of its headquarters and registered office is Zernikedreef 9, 2333 CK Leiden, the Netherlands.

 

ProQR Therapeutics N.V. is the ultimate parent company of the following entities:

 

·                  ProQR Therapeutics Holding B.V. (100%);

·                  ProQR Therapeutics I B.V. (100%);

·                  ProQR Therapeutics II B.V. (100%);

·                  ProQR Therapeutics III B.V. (100%);

·                  ProQR Therapeutics IV B.V. (100%);

·                  ProQR Therapeutics VI B.V. (100%);

·                  ProQR Therapeutics VII B.V. (100%);

·                  ProQR Therapeutics VIII B.V. (100%);

·                  ProQR Therapeutics IX B.V. (100%);

·                  ProQR Therapeutics I Inc. (100%);

·                  Amylon Therapeutics B.V. (80%);

·                  Amylon Therapeutics Inc. (80%).

 

ProQR Therapeutics N.V. is also statutory director of Stichting Bewaarneming Aandelen ProQR (“ESOP Foundation”) and has full control over this entity. ProQR Therapeutics N.V. holds a minority shareholding in Wings Therapeutics Inc.

 

As used in these condensed consolidated financial statements, unless the context indicates otherwise, all references to “ProQR” or the “Company” refer to ProQR Therapeutics N.V. including its subsidiaries and the ESOP Foundation.

 

2. Significant Accounting Policies

 

These condensed consolidated financial statements have been prepared in accordance with IAS 34 - Interim Financial Reporting. Certain information and disclosures normally included in financial statements prepared in accordance with IFRS have been condensed or omitted. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s annual financial statements for the year ended December 31, 2018. In the opinion of management, all adjustments, consisting of normal recurring nature, considered necessary for a fair presentation have been included in the condensed consolidated financial statements.

 

5


 

The Company’s financial results have varied substantially, and are expected to continue to vary, from period to period. The Company believes that its ordinary activities are not linked to any particular seasonal factors.

 

The Company operates in one reportable segment, which comprises the discovery and development of innovative, RNA based therapeutics.

 

3. Adoption of new and revised International Financial Reporting Standards

 

The accounting policies adopted in the preparation of the condensed consolidated financial statements are consistent with those applied in the preparation of the Company’s annual financial statements for the year ended December 31, 2018, except for the change in accounting policies resulting from the implementation of IFRS 16 Leases.

 

IFRS 16 specifies how an entity recognizes, measures, presents and discloses leases. The standard provides a single lessee accounting model, requiring lessees to recognize assets and liabilities for all leases unless the lease term is 12 months or less or the underlying asset has a low value. Upon implementation of the standard on January 1, 2019, the Company recognized a lease liability and a corresponding right-of-use asset. As at September 30, 2019, the carrying amount of the lease liability is € 0.9 million and the carrying amount of the right-of-use asset is € 0.9 million.

 

The impact on the income statement is that operating expenses are replaced by depreciation expenses on the right-of-use asset and interest expenses on the lease liability. The main impact on the statement of cash flows is higher cash flows from operating activities, since cash payments for the principal part of the lease liability are classified as cash flows used in financing activities, whereas such payments were previously classified as cash flows used in operating activities. (effect on nine month period ended September 2019: € 0.9 million).

 

Other new Standards and Interpretations, which became effective as of January 1, 2019, did not have a material impact on our condensed consolidated financial statements.

 

4. Critical Accounting Estimates and Judgments

 

In the application of the Company’s accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

 

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.

 

(a) Share-based payments

 

Share options granted to employees and consultants are measured at the fair value of the equity instruments granted. Fair value is determined through the use of the Black-Scholes option-pricing model, which is considered the most appropriate model for this purpose by management.

 

Initially, the Company’s ordinary shares were not publicly traded and consequently the Company needed to estimate the fair value of its share and the expected volatility of that value. Please refer to the Company’s annual financial statements for the year ended December 31, 2018 for the assumptions used in those estimates. The value of the underlying shares

 

6


 

was determined on the basis of the prior sale of company stock method. As such, the Company has benchmarked the value per share to external transactions of Company shares and external financing rounds.

 

For options granted from the moment of listing, the Company uses the closing price of the ordinary shares on the previous business day as exercise price of the options granted.

 

The result of the share option valuations and the related compensation expense is dependent on the model and input parameters used. Even though Management considers the fair values reasonable and defensible based on the methodologies applied and the information available, others might derive a different fair value for the Company’s share options.

 

(b) Corporate income taxes

 

The Company recognizes deferred tax assets arising from unused tax losses or tax credits only to the extent that the Company has sufficient taxable temporary differences or there is convincing evidence that sufficient taxable profit will be available against which the unused tax losses or unused tax credits can be utilized. Management’s judgment is that such convincing evidence is currently not sufficiently available and a deferred tax asset is therefore only recognized to the extent that the Company has sufficient taxable temporary differences.

 

(c) Grant income

 

Grant income is not recognized until there is reasonable assurance that the Company will comply with the conditions attached to them. Grants are recognized in profit or loss on a systematic basis over the period the Company recognizes as expenses the related costs for which the grants are expected to compensate.

 

(d) Research and development expenditures

 

Research expenditures are currently not capitalized but are reflected in the income statement because the criteria for capitalization are not met. At each balance sheet date, the Company estimates the level of service performed by the vendors and the associated costs incurred for the services performed.

 

Although we do not expect the estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in reporting amounts that are too high or too low in any particular period.

 

5. Cash and Cash Equivalents

 

At September 30, 2019, the Company’s cash and equivalents were € 74,792,000 as compared to € 105,580,000 at December 31, 2018. An amount of € 35,166,000 of the cash balance is denominated in US dollars. The cash balances are held at banks with investment grade credit ratings. The cash at banks is at full disposal of the Company.

 

6. Current liabilities

 

At September 30, 2019 and December 31, 2018, the other current liabilities consisted principally of accruals for services provided by vendors not yet billed, payroll related accruals and other miscellaneous liabilities.

 

7


 

7. Borrowings

 

 

 

September 30, 

 

December 31, 

 

 

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

Innovation credit

 

5,164

 

5,164

 

Accrued interest on innovation credit

 

2,915

 

1,871

 

Convertible notes

 

2,473

 

1,783

 

Accrued interest on convertible notes

 

218

 

568

 

 

 

 

 

 

 

Total borrowings

 

10,770

 

9,386

 

Current portion

 

(260

)

 

 

 

10,510

 

9,386

 

 

On June 1, 2012, ProQR was awarded an Innovation credit by the Dutch government, through its agency RVO of the Ministry of Economic Affairs, for the Company’s cystic fibrosis program. Amounts were drawn under this facility in the course of the years 2013 through 2017. The credit covers 35% of the costs incurred in respect of the program up to € 5.0 million.

 

The credit is interest-bearing at a rate of 10% per annum. Early October 2018 ProQR received a conditional waiver of the €5 million Innovation credit. Consequently, the repayment of the total loan of €7.9 million, including interest, has been waived if conditions are met, which will be reviewed annually for 3 years. The assets which are co-financed with the granted innovation credit are subject to a right of pledge for the benefit of RVO.

 

On December 10, 2018 ProQR was awarded an Innovation credit for the QR-110 program. Amounts will be drawn under this facility from 2018 through 2021. The credit of € 4.7 million through December 31, 2021 will be used to conduct the Phase 2/3 clinical study and efforts to obtain regulatory and ethical market approval (NDA/MAA) of QR-110 for LCA10, of which €0.2 million has been received at September 30, 2019. The credit, including accrued interest of 10% per annum, is repayable depending on obtaining market approval.

 

Convertible loans

 

Convertible loans were issued to Amylon Therapeutics B.V. and are interest-bearing at an average rate of 8% per annum. They are convertible into a variable number of ordinary shares within 36 months at the option of the holder or the Company in case financing criteria are met. Any unconverted loans become payable on demand after 24 — 36 months in equal quarterly terms.

 

8. Shareholders’ equity

 

The authorized share capital of the Company amounting to € 7,200,000 consists of 90,000,000 ordinary shares and 90,000,000 preference shares with a par value of € 0.04 per share. At September 30, 2019, 43,149,987 ordinary shares were issued and fully paid in cash, of which 4,236,792 were held by the Company as treasury shares (December 31, 2018: 4,277,051).

 

In November 2018, the Company issued 112,473 shares in the aggregate amount of $2.5 million, at $22.23 (€19.46) per share to Ionis Pharmaceuticals, Inc. Under the terms of the agreement, an upfront payment in ordinary shares to its common stock, was made to Ionis upon signing the worldwide license agreement. The Company was granted an exclusive worldwide license to QR-1123 and relevant patents. The Company will also make future milestone payments, certain of which will be made in equity and others in cash or equity at the company’s discretion, and royalties on net sales of 20% through the royalty term.

 

On November 7, 2018, the Company filed a shelf registration statement, which permitted: (a) the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 300,000,000 of its ordinary shares, warrants and/or units; and (b) as part of the $ 300,000,000, the offering, issuance and sale by us of up to a maximum aggregate

 

8


 

offering price of $ 75,000,000 of its ordinary shares that may be issued and sold under a sales agreement with H.C. Wainwright & Co in one or more at-the-market offerings. In 2018, no shares were issued pursuant to our ATM facility.

 

In September 2018, the Company consummated an underwritten public offering and concurrent registered direct offering of 6,612,500 ordinary shares at an issue price of $ 15.75 per share. The gross proceeds from this offering amounted to € 89,983,000 while the transaction costs amounted to € 5,792,000, resulting in net proceeds of € 84,191,000.

 

Translation reserve

 

The translation reserve comprises all foreign currency differences arising from the translation of the financial statements of foreign operations.

 

Share options

 

The Company operates an equity-settled share-based compensation plan which was introduced in 2013. Options may be granted to employees, members of the Supervisory Board, members of the Management Board and consultants. The compensation expenses included in operating costs for this plan in the three month period ended September 30, 2019 were € 1,226,000 (three month period ended September 30, 2018: € 735,000), of which € 835,000 (2018: € 550,000) was recorded in general and administrative costs and € 391,000 (2018: € 185,000) was recorded in research and development costs.

 

9. Other income

 

 

 

Three month period ended
September 30,

 

 

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

Grant income

 

518

 

2,835

 

Other income

 

12

 

123

 

 

 

530

 

2,958

 

 

On February 9, 2018, the Company entered into a partnership agreement with Foundation Fighting Blindness (FFB), under which FFB has agreed to provide funding of $7.5 million for the pre-clinical and clinical development of QR-421a for Usher syndrome type 2A targeting mutations in exon 13.

 

In addition, funding was received for our Huntington’s disease program.

 

Grants are recognized in other income in the same period in which the related R&D costs are recognized.

 

10. Research and development costs

 

Research and development costs amount to € 11,074,000 for the three month period ended September 30, 2019 compared to € 6,297,000 for same period in 2018 and are comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, outsourced activities, license and intellectual property costs and other allocated costs.

 

11. General and administrative costs

 

General and administrative costs amount to € 2,903,000 for the three month period ended September 30, 2019 compared to € 2,579,000 for the same period in 2018.

 

9


 

12. Results related to associates

 

Results related to associates for the three month period ended September 30, 2019 consist of our share of the net loss of Wings Therapeutics Inc. amounting to € 119,000.

 

13. Income taxes

 

Due to the operating losses incurred since inception the Company has no tax provisions as of the balance sheet date. Furthermore, no significant temporary differences exist between accounting and tax results. Realization of deferred tax assets is dependent on future earnings, if any, the timing and amount of which are uncertain. Accordingly, the Company has not yet recognized any deferred tax asset related to operating losses.

 

14. Events after balance sheet date

 

In October 2019, the Company consummated an underwritten public offering of 10,454,545 ordinary shares at an issue price of $ 5.50 per share. The gross proceeds from this offering amounted to $ 57,500,000 while the transaction costs amounted to $ 3,575,000, resulting in net proceeds of $ 53,925,000.

 

10


Exhibit 99.2

 

FINAL — FOR RELEASE

 

ProQR Announces Recent Progress and Financial Results for the Third Quarter of 2019

 

·                  Encouraging clinical data reported from Phase 1/2 trial of sepofarsen for LCA10

·                  Initial clinical data from Phase 1/2 trial of QR-421a for Usher syndrome type 2 on track for Q1 2020

·                  QR-1123 Investigational New Drug application active for autosomal dominant retinitis pigmentosa

·                  €49.3 million net proceeds from public offering extends cash runway into 2022

 

LEIDEN, Netherlands & CAMBRIDGE, Mass., Nov 06, 2019 — ProQR Therapeutics N.V. (Nasdaq: PRQR) (the “Company”), a company dedicated to changing lives through the creation of transformative RNA medicines for severe genetic rare diseases, today announced results for the third quarter of 2019.

 

“During the third quarter we made great progress towards our mission to bring novel RNA therapies to patients and we recently strengthened our capital position,” said Daniel A. de Boer, chief executive officer of ProQR. “In October we announced that LCA10 patients experienced a significant improvement in vision after treatment with sepofarsen in a Phase 1/2 trial. These results strengthen our confidence in the design of the ongoing pivotal Illuminate Phase 2/3 trial and our broader inherited retinal diseases pipeline. The Phase 1/2 trial of QR-421a in Usher syndrome is on track to deliver first clinical data in Q1 2020 and we are about to dose a first patient in a Phase 1/2 trial of QR-1123 for adRP. We strengthened our financial position with a public offering in October that will allow us to fund operations into 2022, well beyond the expected top-line readout of Illuminate.”

 

Corporate Highlights and Business Update

 

Sepofarsen (QR-110) for Leber’s congenital amaurosis 10 (LCA10)

 

·                  Presented positive top-line results from the Phase 1/2 clinical trial. In the trial, sepofarsen was observed to be well tolerated with rapid, significant and durable improvements in vision observed at month twelve. The target registration dose for the ongoing Phase 2/3 Illuminate trial showed a favorable benefit/risk profile in the Phase 1/2 trial.

·                  The top-line results from the Phase 1/2 trial support confidence in the design of the ongoing Phase 2/3 Illuminate trial that could be the sole registration trial for the program. Top-line data from Illuminate are expected during the first half of 2021.

·                  Received Rare Pediatric Disease designation from the Food and Drug Administration (FDA) for the treatment of LCA10.

 

QR-421a for Usher syndrome type 2

 

·                  The Phase 1/2 Stellar trial of QR-421a in patients with Usher syndrome type 2 is ongoing and on track to deliver interim data during the first quarter of 2020.

 

QR-1123 for autosomal dominant retinitis pigmentosa (adRP)

 

·                  The FDA cleared the Investigational New Drug (IND) application to start a first-in-human clinical trial in patients with adRP. ProQR plans to start enrolling patients in the Phase 1/2 Aurora trial in 2019.

·                  Received Fast Track designation from the FDA.

 


 

Business Updates

 

·                  Closed an underwritten public offering of 9,090,909 ordinary shares on October 18, 2019 at a price of $5.50 per share with full exercise of underwriters’ option to purchase 1,363,636 additional ordinary shares. Net proceeds totaled approximately €49.3 million. With the addition of this capital ProQR’s operations are funded into 2022.

 

Financial Highlights

 

At September 30, 2019, prior to the offering on October 18th, ProQR held cash and cash equivalents of €74.8 million, compared to €105.6 million at December 31, 2018. The cash balance at September 30, 2019 excludes the net proceeds of €49.3 million from the underwritten offering of ordinary shares in October 2019. Net cash used in operating activities during the three-month period ended September 30, 2019 was €8.8 million, compared to €4.3 million for the same period last year.

 

Research and development costs increased to €11.1 million for the quarter ended September 30, 2019 compared to €6.3 million for the same period last year due to increased clinical trial activity.

 

General and administrative costs increased to €2.9 million for the quarter ended September 30, 2019 compared to €2.6 million for the same period last year.

 

Net loss for the three-month period ended September 30, 2019 was €12.2 million or €0.31 per share, compared to a €6.0 million loss or €0.18 per share for the same period last year.

 

In October 2019 the Company sold an aggregate of 10.5 million ordinary shares, with net proceeds to the Company of €49.3 million.

 

For further financial information for the period ended September 30, 2019, please refer to the financial statements appearing at the end of this release.

 

About Sepofarsen

 

Sepofarsen (QR-110) is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of Leber’s congenital amaurosis 10 due to the p.Cys998X mutation (also known as the c.2991+1655A>G mutation) in the CEP290 gene. The p.Cys998X mutation leads to aberrant splicing of the mRNA and non-functional CEP290 protein. Sepofarsen is designed to enable normal splicing, resulting in restoration of normal (wild type) CEP290 mRNA and subsequent production of functional CEP290 protein. Sepofarsen is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union and received fast-track designation and rare pediatric disease designation from the FDA as well as access to the PRIME scheme by the EMA.

 

About QR-421a

 

QR-421a is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of vision loss in Usher syndrome type 2 and non-syndromic retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A gene. QR-421a is designed to restore functional Usherin protein by using an exon skipping approach with the aim to stop or reverse vision loss in patients. QR-421a is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union and received fast-track designation from the FDA.

 


 

About QR-1123

 

QR-1123 is a first-in-class investigational RNA-based oligonucleotide that was discovered and developed by Ionis Pharmaceuticals using Ionis’ proprietary antisense technology for the treatment of adRP due to the P23H mutation in the RHO gene. The therapy aims to inhibit the formation of the mutated toxic version of the rhodopsin protein by specifically binding the mutated RHO mRNA. Binding of QR-1123 causes allele specific knockdown of the mutant mRNA by a mechanism called RNase H mediated cleavage without affecting the normal RHO mRNA. QR-1123 is intended to be administered through intravitreal injections in the eye and received IND clearance in August 2019.

 

About ProQR

 

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases such as Leber’s congenital amaurosis 10, Usher syndrome and autosomal dominant retinitis pigmentosa. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.

 

*Since 2012*

 

FORWARD-LOOKING STATEMENTS

 

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding sepofarsen (QR-110) and the clinical development and the therapeutic potential thereof, statements regarding our pipeline of programs targeting inherited retinal dystrophies, statements regarding QR-421a, and the clinical development and the therapeutic potential thereof,  statements regarding QR-1123 and the clinical development and therapeutic potential thereof, and our financial position and cash runway. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

 

ProQR Therapeutics N.V.

 

Investor Contact:

Sarah Kiely

ProQR Therapeutics N.V.

T: +1 617 599 6228

skiely@proqr.com

or

Hans Vitzthum

LifeSci Advisors

T: +1 617 535 7743

hans@lifesciadvisors.com

 

Media Contact:

Sara Zelkovic

LifeSci Public Relations

T: +1 646 876 4933

sara@lifescipublicrelations.com

 


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position

 

 

 

September 30,

 

December 31,

 

 

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

74,792

 

105,580

 

Prepayments and other receivables

 

2,450

 

1,544

 

Social securities and other taxes

 

830

 

1,243

 

 

 

 

 

 

 

Total current assets

 

78,072

 

108,367

 

 

 

 

 

 

 

Property, plant and equipment

 

2,413

 

1,864

 

Investments in associates

 

579

 

 

 

 

 

 

 

 

Total assets

 

81, 064

 

110,231

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

 

Equity

 

 

 

 

 

Equity attributable to owners of the Company

 

59,871

 

92,915

 

Non-controlling interests

 

(452

)

(230

)

Total equity

 

59,419

 

92,685

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Borrowings

 

260

 

 

Lease liabilities

 

890

 

 

Trade payables

 

668

 

135

 

Social securities and other taxes

 

15

 

 

Pension premiums

 

13

 

7

 

Deferred income

 

984

 

545

 

Other current liabilities

 

8,305

 

7,473

 

 

 

 

 

 

 

Total current liabilities

 

11,135

 

8,160

 

 

 

 

 

 

 

Borrowings

 

10,510

 

9,386

 

Lease liabilities

 

 

 

 

 

 

 

 

 

Total liabilities

 

21,645

 

17,546

 

 

 

 

 

 

 

Total equity and liabilities

 

81,064

 

110,231

 

 


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Profit or Loss and OCI

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

 

 

 

 

Three month period

 

Nine month period

 

 

 

ended September 30, 

 

ended September 30, 

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Other income

 

530

 

2,958

 

1,509

 

4,428

 

 

 

 

 

 

 

 

 

 

 

Research and development costs

 

(11,074

)

(6,297

)

(32,560

)

(19,972

)

General and administrative costs

 

(2,903

)

(2,579

)

(8,970

)

(7,900

)

 

 

 

 

 

 

 

 

 

 

Total operating costs

 

(13,977

)

(8,876

)

(41,530

)

(27,872

)

 

 

 

 

 

 

 

 

 

 

Operating result

 

(13,447

)

(5,918

)

(40,021

)

(23,444

)

Finance income and expense

 

1,375

 

(74

)

1,339

 

(664

)

Results related to associates

 

(119

)

 

579

 

 

 

 

 

 

 

 

 

 

 

 

Result before corporate income taxes

 

(12,191

)

(5,992

)

(38,103

)

(24,108

)

Income taxes

 

 

 

(64

)

(1

)

 

 

 

 

 

 

 

 

 

 

Result for the period

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

Other comprehensive income

 

147

 

(4

)

121

 

(15

)

 

 

 

 

 

 

 

 

 

 

Total comprehensive income (attributable to owners of the Company)

 

(12,044

)

(5,996

)

(38,046

)

(24,124

)

 

 

 

 

 

 

 

 

 

 

Result attributable to

 

 

 

 

 

 

 

 

 

Owners of the Company

 

(12,139

)

(5,959

)

(37,945

)

(23,974

)

Non-controlling interests

 

(52

)

(33

)

(222

)

(135

)

 

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

 

 

 

 

 

 

 

 

 

 

Share information

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding(1)

 

38,912,701

 

33,355,327

 

38,902,203

 

32,440,220

 

 

 

 

 

 

 

 

 

 

 

Earnings per share attributable to the equity holders of the Company (expressed in Euro per share)

 

 

 

 

 

 

 

 

 

Basic loss per share(1)

 

(0.31

)

(0.18

)

(0.98

)

(0.74

)

Diluted loss per share(1)

 

(0.31

)

(0.18

)

(0.98

)

(0.74

)

 


(1)         For this period presented in these financial statements, the potential exercise of share options is not included in the diluted earnings per share calculation as the Company was loss-making in all periods. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal in this period.

 


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Changes in Equity

 

 

 

Attributable to owners of the Company

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Settled

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Employee

 

 

 

 

 

 

 

Non-

 

 

 

 

 

Number of

 

Share

 

Share

 

Benefit

 

Translation

 

Accumulated

 

 

 

controlling

 

Total

 

 

 

shares

 

Capital

 

Premium

 

Reserve

 

Reserve

 

Deficit

 

Total

 

interests

 

Equity

 

 

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Balance at January 1, 2018

 

36,425,014

 

1,457

 

148,763

 

8,377

 

136

 

(119,370

)

39,363

 

(38

)

39,325

 

Result for the period

 

 

 

 

 

 

(23,974

)

(23,974

)

(135

)

(24,109

)

Other comprehensive income

 

 

 

 

 

(15

)

 

(15

)

 

(15

)

Recognition of share-based payments

 

 

 

 

2,245

 

 

 

2,245

 

 

2,245

 

Issuance of ordinary shares

 

6,612,500

 

265

 

84,032

 

 

 

 

84,297

 

 

84,297

 

Share options exercised

 

 

 

659

 

 

 

 

659

 

 

659

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

43,037,514

 

1,722

 

233,454

 

10,622

 

121

 

(143,344

)

102,575

 

(173

)

102,402

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2019

 

43,149,987

 

1,726

 

235,744

 

10,780

 

108

 

(155,443

)

92,915

 

(230

)

92,685

 

Result for the period

 

 

 

 

 

 

(37,945

)

(37,945

)

(222

)

(38,167

)

Other comprehensive income

 

 

 

 

 

121

 

 

121

 

 

121

 

Recognition of share-based payments

 

 

 

 

4,614

 

 

 

4,614

 

 

4,614

 

Share options lapsed

 

 

 

 

(33

)

 

 

33

 

 

 

 

Share options exercised

 

 

 

166

 

(115

)

 

115

 

166

 

 

166

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2019

 

43,149,987

 

1,726

 

235,910

 

15,246

 

229

 

(193,240

)

59,871

 

(452

)

59,419

 

 


 

PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Cash Flows

 

 

 

Three month period 

 

Nine month period

 

 

 

ended September 30, 

 

ended September 30, 

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

€ 1,000

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

 

Net result

 

(12,191

)

(5,992

)

(38,167

)

(24,109

)

Adjustments for:

 

 

 

 

 

 

 

 

 

— Depreciation

 

506

 

242

 

1,543

 

725

 

— Share-based compensation

 

1,226

 

734

 

4,614

 

2,245

 

— Financial income and expenses

 

(1,375

)

74

 

(1,339

)

664

 

— Results related to associates

 

119

 

 

(579

)

 

— Net foreign exchange gain / (loss)

 

148

 

(4

)

122

 

(15

)

 

 

 

 

 

 

 

 

 

 

Changes in working capital

 

2,718

 

656

 

1,744

 

1,074

 

Cash used in operations

 

(8,849

)

(4,290

)

(32,062

)

(19,416

)

 

 

 

 

 

 

 

 

 

 

Corporate income tax paid

 

 

1

 

(64

)

 

Interest received

 

90

 

32

 

176

 

25

 

Interest paid

 

(13

)

 

(64

)

 

 

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

(8,772

)

(4,257

)

(32,014

)

(19,391

)

 

 

 

 

 

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

 

 

 

 

 

Purchases of intangible assets

 

 

 

 

 

Purchases of property, plant and equipment

 

(32

)

(99

)

(341

)

(285

)

 

 

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

(32

)

(99

)

(341

)

(285

)

 

 

 

 

 

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

 

 

 

 

 

Proceeds from issuance of shares, net of transaction costs

 

 

84,295

 

 

84,295

 

Proceeds from exercise of share options

 

2

 

637

 

166

 

660

 

Proceeds from borrowings

 

 

 

 

101

 

Proceeds from convertible loans

 

 

115

 

690

 

430

 

Repayment of lease liability

 

(290

)

 

(861

)

 

 

 

 

 

 

 

 

 

 

 

Net cash (used in)/generated by financing activities

 

(288

)

85,047

 

(5

)

85,486

 

 

 

 

 

 

 

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

(9,092

)

80,691

 

(32,360

)

65,810

 

 

 

 

 

 

 

 

 

 

 

Currency effect cash and cash equivalents

 

1,420

 

57

 

1,572

 

(193

)

Cash and cash equivalents, at beginning of the period

 

82,464

 

32,968

 

105,580

 

48,099

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

74,792

 

113,716

 

74,792

 

113,716

 

 

ProQR Therapeutics N.V. | Zernikedreef 9, 2333 CK Leiden, The Netherlands | +31 88 166 7000 | info@proqr.com | www.proqr.com