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

August 5, 2021

 

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    Form 40-F 

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): 

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): 


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 six-month periods ended June 30, 2021, and furnished as Exhibit 99.2 to this Report on Form 6-K is a press release of ProQR Therapeutics N.V. dated August 5, 2021, announcing the Company’s results for the three- and six-month periods ended June 30, 2021. 


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: August 5, 2021

By:

/s/ Smital Shah

Smital Shah

Chief Financial Officer


INDEX TO EXHIBITS


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Table of Contents

Exhibit 99.1

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

 

PAGE

Unaudited Condensed Consolidated Statement of Financial Position at June 30, 2021 and December 31, 2021

1

Unaudited Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income for the Three and Six Month Periods ended June 30, 2021 and 2020

2

Unaudited Condensed Consolidated Statement of Changes in Equity for the Three and Six Month Periods Ended June 30, 2021 and 2020

3

Unaudited Condensed Consolidated Statement of Cash Flows for the Three and Six Month Periods ended June 30, 2021 and 2020

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Table of Contents

PAGE 1

Unaudited Condensed Consolidated Financial Statements

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

June 30, 

December 31, 

2021

2020

€ 1,000

€ 1,000

Assets

  

  

Current assets

  

  

Cash and cash equivalents

139,442

75,838

Prepayments and other receivables

3,761

3,762

Social securities and other taxes

381

421

Total current assets

143,584

80,021

Property, plant and equipment

17,928

18,601

Investments in associates

224

107

Investments in financial assets

621

Total assets

162,357

98,729

Equity and liabilities

  

  

Equity

  

Equity attributable to owners of the Company

118,106

57,091

Non-controlling interests

(563)

(545)

Total equity

117,543

56,546

Current liabilities

  

  

Borrowings

1,562

1,135

Lease liabilities

1,383

1,260

Derivative financial instruments

1,617

839

Trade payables

276

221

Current income tax liability

Social securities and other taxes

127

22

Pension premiums

6

Deferred income

1,659

700

Other current liabilities

5,750

6,118

Total current liabilities

12,374

10,301

Borrowings

16,972

16,189

Lease liabilities

15,468

15,693

Total liabilities

44,814

42,183

Total equity and liabilities

162,357

98,729

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

Table of Contents

PAGE 2

Unaudited Condensed Consolidated Financial Statements

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

Six month period

ended June 30, 

 

ended June 30, 

    

2021

2020

 

2021

2020

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Revenue

243

243

Other income

411

8,674

552

8,937

Research and development costs

(9,735)

(8,587)

(18,640)

(21,412)

General and administrative costs

(4,122)

(3,446)

(7,461)

(7,364)

Total operating costs

(13,857)

(12,033)

(26,101)

(28,776)

  

  

  

  

Operating result

(13,203)

(3,359)

(25,306)

(19,839)

Finance income and expense

(2,464)

(697)

(2,757)

(161)

Results related to associates

(52)

(107)

(186)

Gain on recognition of financial asset

621

Results related to financial liabilities measured at fair value through profit or loss

(33)

(762)

  

  

  

  

Result before corporate income taxes

(15,700)

(4,108)

(28,311)

(20,186)

Income taxes

(53)

(11)

(60)

(11)

  

  

  

  

Result for the period

(15,753)

(4,119)

(28,371)

(20,197)

Other comprehensive income (foreign exchange differences on foreign operation)

(141)

(135)

255

121

  

  

  

  

Total comprehensive income

(15,894)

(4,254)

(28,116)

(20,076)

Result attributable to

  

  

  

  

Owners of the Company

(15,746)

(4,112)

(28,353)

(20,167)

Non-controlling interests

(7)

(7)

(18)

(30)

(15,753)

(4,119)

(28,371)

(20,197)

Total comprehensive income attributable to

Owners of the Company

(15,887)

(4,247)

(28,098)

(20,046)

Non-controlling interests

(7)

(7)

(18)

(30)

(15,894)

(4,254)

(28,116)

(20,076)

  

  

  

  

Share information

  

  

  

  

Weighted average number of shares outstanding1

66,147,153

50,021,194

58,521,508

49,963,614

Earnings per share attributable to owners of the Company (Euro per share)

Basic loss per share1

(0.24)

(0.08)

(0.48)

(0.40)

Diluted loss per share1

(0.24)

(0.08)

(0.48)

(0.40)

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

1. For these periods the potential exercise of share options is not included in the diluted earnings per share as the Company was loss-making. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal.

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PAGE 3

Unaudited Condensed Consolidated Financial Statements

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

Attributable to owners of the Company

  

Number
of shares

  

Share
Capital

  

Share
Premium

  

Equity settled
Employee
Benefit
Reserve

  

Option
premium on
convertible
loan

  

Translation
Reserve

  

Accumulated
Deficit

  

Total

  

Non-
controlling
interests

  

Total
Equity

 

  

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Balance at January 1, 2020

 

53,975,838

2,159

287,214

16,551

151

(211,746)

94,329

(496)

93,833

Result for the period

 

(20,167)

(20,167)

(30)

(20,197)

Other comprehensive income

 

121

121

121

Recognition of share-based payments

 

2

283

4,542

4,827

4,827

Issuance of ordinary shares

100,902

2

270

272

272

Treasury shares transferred

(296,122)

Share options lapsed

(60)

60

Share options exercised

296,122

712

(458)

458

712

712

Balance at June 30, 2020

 

54,076,740

2,163

288,479

20,575

272

(231,395)

80,094

(526)

79,568

Balance at January 1, 2021

 

54,131,553

2,165

288,757

23,825

280

(189)

(257,747)

57,091

(545)

56,546

Result for the period

 

(28,353)

(28,353)

(18)

(28,371)

Other comprehensive income

 

255

255

255

Recognition of share-based payments

 

112,657

5

382

2,719

3,106

3,106

Issuance of ordinary shares

16,508,475

660

84,594

85,254

85,254

Treasury shares transferred

(127,303)

Recognition of equity component of convertible loan

Share options lapsed

(160)

160

Share options exercised

243,189

753

(541)

541

753

753

 

  

  

  

  

  

  

  

  

  

  

Balance at June 30, 2021

 

70,868,571

2,830

374,486

25,843

280

66

(285,399)

118,106

(563)

117,543

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

Table of Contents

PAGE 4

Unaudited Condensed Consolidated Financial Statements

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

Three month period 

Six month period 

ended June 30, 

 

ended June 30, 

    

2021

2020

2021

2020

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Cash flows from operating activities

  

  

  

  

Net result

(15,753)

(4,119)

(28,371)

(20,197)

Adjustments for:

— Depreciation

602

530

1,233

1,052

— Share-based compensation

1,471

1,802

2,719

4,672

— Other income

(8,423)

(8,423)

— Financial income and expenses

2,464

696

2,757

161

— Results related to associates

52

107

186

— Gain on recognition of financial asset

(621)

— Results related to financial liabilities measured at fair value through profit or loss

33

762

— Net foreign exchange gain / (loss)

(141)

(135)

255

121

— Income tax expenses

53

11

60

11

Changes in working capital

1,915

(918)

567

(3,119)

Cash used in operations

(9,356)

(10,504)

(20,532)

(25,536)

  

  

  

  

Corporate income tax paid

(53)

(11)

(60)

(11)

Interest received

5

62

5

91

Interest paid

(575)

(34)

(1,153)

(38)

  

  

  

  

Net cash used in operating activities

(9,979)

(10,487)

(21,740)

(25,494)

  

  

  

  

Cash flow from investing activities

Purchases of property, plant and equipment

(52)

(344)

(84)

(542)

  

  

  

  

Net cash used in investing activities

(52)

(344)

(84)

(542)

  

  

  

  

Cash flow from financing activities

  

  

  

  

Proceeds from issuance of shares, net of transaction costs

82,601

85,254

Proceeds from exercise of share options

185

243

753

712

Proceeds from borrowings

569

289

569

579

Proceeds from convertible loans

65

65

Repayment of lease liability

(14)

(105)

(250)

(307)

  

  

  

  

Net cash generated by financing activities

83,341

492

86,326

1,049

  

  

  

  

Net increase (decrease) in cash and cash equivalents

73,310

(10,339)

64,502

(24,987)

  

  

  

  

Currency effect cash and cash equivalents

(1,746)

(583)

(898)

178

Cash and cash equivalents, at beginning of the period

67,878

98,063

75,838

111,950

  

  

  

  

Cash and cash equivalents at the end of the period

139,442

87,141

139,442

87,141

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

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PAGE 5

Unaudited Condensed Consolidated Financial Statements

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 V 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. The Company holds an 8% minority shareholding in Yarrow Biotechnology, 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 the recognition and measurement criteria of IFRS. Certain disclosures required by IAS 34 Interim Financial Statements 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, 2020. In the opinion of management, all events and transactions that are significant to an understanding of the changes in financial position and performance of the Company since the end of the last annual reporting period are disclosed in these condensed consolidated financial statements.

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PAGE 6

Unaudited Condensed Consolidated Financial Statements

Revenue is recognized in accordance with the recognition and measurement criteria of IFRS 15 Revenue from contracts with customers.

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, 2020.

New Standards and Interpretations, which became effective as of January 1, 2021, 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.

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.

Convertible debt

The terms of our convertible debt agreements are evaluated to determine whether the convertible debt instruments contain both liability and equity components, in which case the instrument is a compound financial instrument. Convertible debt agreements are also evaluated to determine whether they contain embedded derivatives, in which case the instrument is a hybrid financial instrument. Judgement is required to determine the classification of such financial instruments based on the terms and conditions of the convertible debt agreements, the currencies in which the debt instruments are denominated and the Company’s functional currency.

Estimation methods are used to determine the fair values of the liability and equity components of compound financial instruments and to determine the fair value of embedded derivatives included in hybrid financial instruments. The determination of the effective interest used for the host contracts of hybrid financial instruments and the liability

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PAGE 7

Unaudited Condensed Consolidated Financial Statements

components of compound financial instruments is dependent on the outcome of such estimations. Evaluating the reasonableness of these estimations and the assumptions and inputs used in the valuation methods requires a significant amount of judgement and is therefore subject to an inherent risk of error.

5. Cash and Cash Equivalents

At June 30, 2021, the Company’s cash and cash equivalents were € 139,442,000 as compared to € 75,838,000 at December 31, 2020. The cash balances are held at banks with investment grade credit ratings. The cash at banks is at full disposal of the Company.

6. Property, plant and equipment

At June 30, 2021 and December 31, 2020, property plant and equipment consisted of buildings and leasehold improvements, laboratory equipment and other assets. Buildings and leasehold improvements include a right-of-use asset relating to the lease of our Leiden office and laboratory space, with a carrying amount of € 16,388,000 at June 30, 2021 (December 31, 2020: € 16,775,000).

7. Current liabilities

At June 30, 2021 and December 31, 2020, the other current liabilities consisted principally of accruals for services provided by vendors not yet billed, payroll related accruals and other miscellaneous liabilities.

8. Borrowings

June 30, 

December 31,

    

2021

2020

€ 1,000

€ 1,000

Innovation credit

3,339

2,770

Accrued interest on innovation credit

458

307

Convertible notes

14,229

13,812

Accrued interest on convertible notes

508

435

  

  

Total borrowings

18,534

17,324

Current portion

(1,562)

(1,135)

16,972

16,189

On December 10, 2018 ProQR was awarded an Innovation credit for the sepofarsen program for LCA 10. Amounts will be drawn under this facility from 2018 through 2022. The total credit of € 4.7 million will be used to conduct the Phase 2/3 clinical study for sepofarsen and to finance efforts to obtain regulatory and ethical market approval (NDA/MAA). The credit, including accrued interest of 10% per annum, is repayable depending on ProQR obtaining market approval for sepofarsen. An amount of € 3.3 million had been received as at June 30, 2021. Accumulated interest amounted to € 0.5 million as at June, 2021. The assets that are co-financed with the granted innovation credit are subject to a right of pledge for the benefit of RVO.

Convertible loans

On July 14, 2020, the Company entered into a convertible debt financing agreement with Pontifax Medison Debt Financing. Under the agreement, up to $ 30 million in convertible debt financing has been made available to the Company

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Unaudited Condensed Consolidated Financial Statements

in three tranches of $ 10 million each that will mature over a 54 month period and have an interest-only period of 24 months. One tranche of $ 10 million had been drawn down as of June 30, 2021.

A second close of the convertible debt financing agreement was completed on August 6, 2020 with Kreos Capital. Under the second agreement, up to € 15 million in convertible debt financing has been made available to the Company in three tranches of € 5 million each that will mature over a 54 month period and have an interest-only period of 24 months. One tranche of € 5 million had been drawn down as of June 30, 2021.

Pontifax and/or Kreos may elect to convert the outstanding loans into ProQR ordinary shares at any time prior to repayment at a fixed conversion price. ProQR also has the ability to convert the loans into its ordinary shares, at the same conversion price, if the Company’s stock price reaches a pre-determined threshold. In connection with the loan agreement, the Company issued to Pontifax and Kreos warrants to purchase up to an aggregate of 302,676 shares of its common stock at a fixed exercise price.

Pontifax’ conversion option and warrants are accounted for as embedded derivatives and are recognized separately from the host contract as financial liabilities at fair value through profit or loss. The host contract is recognized at amortized cost.

The Kreos loan is accounted for as a compound financial instrument. The liability component is recognized at amortized cost. The equity component is initially recognized at fair value as option premium on convertible loan and will not be subsequently remeasured. Kreos’ warrants are accounted for as embedded derivatives and are recognized as financial liabilities at fair value through profit or loss.

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.

9. Lease liabilities

At June 30, 2021 and December 31, 2020, lease liabilities primarily consisted of the Company’s lease of office and laboratory facilities at Zernikedreef in Leiden, the Netherlands.

The lease agreement for our Leiden headquarters, where our main offices and laboratories are located, was put in place on July 1, 2020 and the current lease term is 11 years. The lease agreement may be further extended for subsequent 5 year terms. The carrying amount of the right-of-use asset is disclosed in note 6 Property, plant & equipment.

10. Shareholders’ equity

The authorized share capital of the Company amounting to € 13,600,000 consists of 170,000,000 ordinary shares and 170,000,000 preference shares with a par value of € 0.04 per share. At June 30, 2021, 70,868,571 ordinary shares were issued and fully paid in cash, of which 3,799,440 were held by the Company as treasury shares (December 31, 2020: 3,926,743).

On November 7, 2018, the Company filed a shelf registration statement, which permitted 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.

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Unaudited Condensed Consolidated Financial Statements

On March 31, 2020, the Company entered into a sales agreement, which permitted the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 75,000,000 of its ordinary shares that may be issued and sold in one or more at-the-market offerings with Citigroup Global Markets, Inc. and Cantor Fitzgerald & Co. In 2020, no shares were issued pursuant to this ATM facility.

In January 2021, the Company issued 585,398 ordinary shares under our sales agreement for at-the-market offerings with Citigroup Global Markets Inc. and Cantor Fitzgerald & Co. The gross proceeds from this sale amounted to € 2,767,000, with transaction costs amounting to € 114,000, resulting in net proceeds of € 2,653,000.

In April 2021, the Company consummated an underwritten public offering of 15,923,077 ordinary shares at an issue price of $ 6.50 per share. The gross proceeds from this offering amounted to € 88,115,000 while the transaction costs amounted to € 5,499,000, resulting in net proceeds of € 82,616,000.

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 six month period ended June 30, 2021 were € 2,719,000 (six month period ended June 30, 2020: € 1,673,000), of which € 1,673,000 (six month period ended June 30, 2020: € 1,103,000) was recorded in general and administrative costs and € 1,046,000 (six month period ended June 30, 2020: € 570,000) was recorded in research and development costs.

11. Revenue

In May 2021, the Company entered into an exclusive worldwide license and discovery collaboration for an undisclosed target with Yarrow Biotechnology, Inc. (“Yarrow”). Under the terms of the agreement, ProQR is eligible to receive upfront and milestone payments, and royalties on the net sales of any resulting products. ProQR also received 8% of the shares of Yarrow’s common stock.

In the six month period ended June 30, 2021, revenue amounting to € 243,000 was recognized over time as ProQR progressed towards satisfying its performance obligation under the agreement with Yarrow.

12. Other income

Six month period

ended June 30, 

    

2021

2020

€ 1,000

€ 1,000

Grant income

501

8,869

Other income

51

68

552

8,937

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Unaudited Condensed Consolidated Financial Statements

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.

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

13. Research and development costs

Research and development costs amount to € 18,640,000 for the six month period ended June 30, 2021 (six month period ended June 30, 2020: € 21,412,000) 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.

14. General and administrative costs

General and administrative costs amount to € 7,461,000 for the six month period ended June 30, 2021 (six month period ended June 30, 2020: € 7,364,000).

15. Results related to associates

In January 2021, ProQR’s associate company Wings Therapeutics Inc. merged into Phoenicis Therapeutics Inc. Consequently, Wings Therapeutics Inc. ceased to exist and the related investment was derecognized. ProQR does not have significant influence in Phoenicis Therapeutics Inc. Our interest in Phoenicis is recognized as a financial asset, as disclosed in note 16.

As disclosed in note 11, in May 2021, the Company obtained an 8% share in the common stock of Yarrow Biotechnology, Inc. Although ProQR only owns 8% of Yarrow’s shares, the Company has significant influence over Yarrow by virtue of its right to appoint one of Yarrow’s three board members, as well as its participation in Yarrow’s policy-making process, amongst other factors. As such, our interest in Yarrow amounting to € 224,000 at June 30, 2021 is recognized as an investment in associate.

The results related to associates for the six month period ended June 30, 2021 amount to a loss on derecognition of Wings Therapeutics Inc. of € 107,000. The results related to associates for the six month period ended June 30, 2020 amount to a loss of € 186,000 and consist of our share of the net losses of Wings Therapeutics Inc.

16. Gain on recognition of financial asset

In January 2021, Wings Therapeutics Inc. merged into Phoenicis Therapeutics Inc. by means of a non-cash transaction. ProQR holds a 3.9% interest in Phoenicis Therapeutics Inc.

The gain on recognition of financial asset for the six month period ended June 30, 2021 of € 621,000 relates to the gain realized on our investment in the equity instruments of Phoenicis Therapeutics Inc. The Company elected to recognize subsequent changes in the fair value of our investment in Phoenicis in Other Comprehensive Income. There have been no changes in the fair value of our investment in Phoenicis since the initial recognition.

17. Income taxes

The current income tax liability amounts to € nil at June 30, 2021 (December 31, 2020: € nil). 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.

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Unaudited Condensed Consolidated Financial Statements

On October 5, 2020, the Dutch State Secretary for Finance submitted an amendment to the Tax Plan 2021 to the House of Representatives, which provides for changes in the loss offset rules. On May 28, 2021, the amendment was substantively enacted. Effective from January 1, 2022, losses may be carried forward indefinitely. However, the offset of losses will be limited in a given year against the first € 1 million of taxable profit. For taxable profit in excess of this amount, losses may only be offset up to 50% of this excess.

18. Events after balance sheet date

No significant events occurred after the balance sheet date.

Exhibit 99.2

ProQR Announces second Quarter 2021 Operating and Financial Results

Top-line data from Phase 2/3 pivotal Illuminate trial of sepofarsen for CEP290-mediated LCA10 on track for H1 2022
QR-421a pivotal Sirius and Celeste Phase 2/3 trials in Usher syndrome and retinitis pigmentosa expected to start by year end 2021
Initial clinical data from Phase 1/2 Aurora trial of QR-1123 for autosomal dominant retinitis pigmentosa expected in Q4 2021

LEIDEN, Netherlands & CAMBRIDGE, Mass., August 5, 2021 -- ProQR Therapeutics N.V. (Nasdaq: PRQR) (the “Company”), a company dedicated to changing lives through the creation of transformative RNA therapies for genetic eye diseases, today reported its financial and operating results for the second quarter ended June 30, 2021, and provided a business update.

“Across our pipeline, on the partnering front, and with our balance sheet, we have generated significant momentum in the first half of the year as we work to advance our therapies for patients with genetic eye disease,” said Daniel A. de Boer, Founder and CEO of ProQR. “We completed enrollment in the pivotal trial of sepofarsen, reported positive clinical data for QR-421a, formed a partnership with Yarrow Biotechnology, and strengthened our financial position with a public offering. During the second half of the year, we expect to share the first clinical data for QR-1123 for adRP focusing on safety and tolerability, start our pivotal trials of QR-421a in Usher syndrome and nsRP, and progress enrollment of our fourth pipeline program for a genetic eye disease, QR-504a for Fuchs endothelial corneal dystrophy.”

Business Operations and Program Updates

Sepofarsen for Leber congenital amaurosis 10 (LCA10):

The Company expects to report top-line results from the pivotal Phase 2/3 Illuminate trial in H1 2022. The Illuminate trial completed enrollment in January following randomization of 36 patients aged 8 years or older to receive either sepofarsen at the target registration dose, a low dose, or sham treatment. The primary endpoint for Illuminate is mean change from baseline in best-corrected visual acuity (BCVA) at Month 12.
Enrollment is ongoing in the Phase 2/3 Brighten trial of sepofarsen in LCA10. The primary objective of this study is to evaluate safety and tolerability of sepofarsen in patients under 8 years of age.

QR-421a for Usher syndrome and non-syndromic retinitis pigmentosa (nsRP):

Based on the findings from the Phase 1/2 Stellar trial, the Company plans to advance QR-421a into two pivotal Phase 2/3 trials – Sirius in advanced patients, and Celeste in early-moderate patient – by year end, pending finalization of the study designs with Regulatory authorities. Each trial could potentially serve as the sole registration trial.
In Q3, the Company expects to begin enrolling eligible patients from the Phase 1/2 Stellar trial in the open-label extension study Helia, which will include multiple dose treatments for both eyes.

QR-1123 for autosomal dominant retinitis pigmentosa (adRP):

The Company has completed enrollment of the fifth single-dose cohort of patients in the Phase 1/2 Aurora trial for adRP with initial clinical data (n=11) expected in Q4. Aurora is a first-in-human clinical study, designed to evaluate safety and tolerability. The Company will also be looking for evidence of target engagement and/or disease modification to inform the next steps in development.

QR-504a for Fuchs Endothelial Corneal Dystrophy (FECD):

The Fuchs Focus study is currently open for enrollment. This study is evaluating safety, tolerability, and molecular biomarker(s), i.e., target engagement, in the corneal endothelium following a single intravitreal injection of QR-504a in approximately 10 patients with FECD who are scheduled for corneal transplant with concurrent lens replacement.
ProQR anticipates reporting initial data from this trial in 2022.

Business updates:

In May, Yarrow Biotechnology, Inc., an RTW Investments, LP incubated company, licensed exclusive rights to ProQR’s antisense oligonucleotide technology to develop and commercialize potential therapies for an undisclosed non-ophthalmic target. Under the terms of the agreement, ProQR is eligible to receive up to $115 million of upfront and milestone payments, plus single digit percentage royalties on the net sales of any resulting products during the royalty term. ProQR will also have the right to receive an undisclosed percentage of equity in the form of shares of common stock of Yarrow.
In April, the Company closed an underwritten public offering with gross proceeds totaling approximately $103.5 million.

Financial Highlights

On June 30, 2021, ProQR held cash and cash equivalents of €139.4 million, compared to €75.8 million on December 31, 2020. Net cash used in operating activities during the three-month period ended June 30, 2021 was €10.0 million, compared to €10.5 million for the same period last year.

Research and development costs were €9.7 million for the quarter ended June 30, 2021 compared to €8.6 million for the same period last year.

General and administrative costs were €4.1 million for the quarter ended June 30, 2021 compared to €3.4 million for the quarter ended June 30, 2020.

Net loss for the three-month period ended June 30, 2021 was €15.8 million, or €0.24 per diluted share, compared to €4.1 million, or €0.08 per diluted share, for the same period last year. For further financial information for the period ending June 30, 2021, please refer to the financial statements appearing at the end of this release.

About Leber Congenital Amaurosis 10 (LCA10)

Leber congenital amaurosis (LCA) is the most common cause of blindness due to genetic disease in children. It consists of a group of diseases of which LCA10 is the most frequent and one of the most severe forms. LCA10 is caused by mutations in the CEP290 gene, of which the p.Cys998X mutation has the highest prevalence. LCA10 leads to early loss of vision causing most people to lose their sight in the first few years of life. To date, there are no treatments approved that treat the underlying cause of the disease. Approximately 2,000 people in the Western world have LCA10 because of this mutation.

About Sepofarsen

Sepofarsen (QR-110) is being evaluated in the pivotal Phase 2/3 Illuminate trial and is a first-in-class investigational RNA therapy designed to address the underlying cause of Leber 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 Usher Syndrome Type 2 and Non-Syndromic Retinitis Pigmentosa

Usher syndrome is the leading cause of combined deafness and blindness. People with Usher syndrome type 2a are usually born with hearing loss and start to have progressive vision loss during adulthood. The vision loss can also occur without hearing loss in a disease called non-syndromic retinitis pigmentosa. Usher syndrome type 2a and non-syndromic retinitis pigmentosa can be caused by mutations in the USH2A gene. To date, there are no pharmaceutical treatments approved or in clinical development that treat the vision loss associated with mutations in USH2A.

About QR-421a

QR-421a is a first-in-class investigational RNA therapy designed to address the underlying cause of vision loss in Usher syndrome type 2a and non-syndromic retinitis pigmentosa 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 US and the European Union and received fast-track and rare pediatric disease designations from the FDA.

About Autosomal Dominant Retinitis Pigmentosa (adRP)

Autosomal dominant retinitis pigmentosa, or adRP, is a severe and rare genetic disease that causes progressive problems in night vision during childhood, leading to visual field loss and frequently resulting in blindness in mid adulthood. In the United States, the most prevalent mutation associated with adRP is the P23H point mutation (also known as the c.68C>A mutation) in the rhodopsin (RHO) gene and affects approximately 2,500 people. This mutation causes misfolding of the rhodopsin protein that becomes toxic to the photoreceptor cells and at the same time diminishes the function of the wild type allele. Over time this results in cell death and progressive vision loss. There are currently no therapies approved or in clinical development for P23H adRP. A natural history study in patients with P23H adRP has been conducted.

About QR-1123

QR-1123 is being evaluated in the Phase 1/2 Aurora trial and is a first-in-class investigational RNA therapy designed to treat adRP due to the P23H mutation in the RHO gene. QR-1123 was discovered and developed by Ionis Pharmaceuticals using Ionis’ proprietary antisense technology. 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. QR-1123 has been granted Orphan Drug designation in the United States and received Fast Track designation from the FDA.

About Fuchs Endothelial Corneal Dystrophy (FECD)

Fuchs endothelial corneal dystrophy (FECD) type 3 is a common genetic disease that leads to progressive degeneration of the corneal endothelium resulting in corneal edema, scarring and vision loss. Blisters on the cornea are a major cause of pain in patients with advanced FECD. Currently there are no treatment options available to stop or slow down FECD and disease management is aimed to reduce symptoms. The only effective therapy for late-stage FECD is corneal transplantation. The availability of donors, risk of rejection, and the inherent risk of such surgeries are some of the limitations of this option. FECD is a common disorder affecting more than 4% of people over the age of 40 in the United States, with similar numbers reported for other parts of the World. Trinucleotide repeat (TNR) expansion mutations in the TCF4 gene are a common cause of FECD. In people of European descent, around 75% of FECD patients have TNR expansions in TCF4.

About QR-504a

QR-504a is a first-in-class investigational RNA therapy designed to address the underlying cause of Fuchs endothelial corneal dystrophy (FECD) due to trinucleotide repeat (TNR) expansion mutations in the TCF4 gene. The TNR expansions cause the TCF4 RNA to aggregate in the corneal endothelial cells forming the characteristic nuclear RNA foci and eventually resulting in FECD. QR-504a is designed to target the TNRs in the TCF4 RNA. The aim is to reduce aggregation and the formation of RNA foci to prevent or stop corneal degeneration in patients with FECD. QR-504a is intended to be administered through intravitreal injections in the eye.

About ProQR

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

Learn more about ProQR at www.proqr.com.


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 QR-421a and the clinical development and the therapeutic potential thereof, statements regarding QR-1123 and the clinical development and therapeutic potential thereof, statements regarding the QR-504a and the clinical development and therapeutic potential thereof, statements regarding our pipeline of programs targeting inherited retinal dystrophies, including timing of commencing clinical trials and enrollment of patients therein, our other programs and business operations, the expected impact of the COVID-19 on our business operations, including our research and development plans and timelines and the supply chain for our clinical and development programs, statements regarding the collaboration with RTW and Yarrow and the intended benefits thereof, including milestone and royalty payments from commercial product sales, if any, from the products covered by the collaboration and the issuance of equity in Yarrow to ProQR 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. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners whose operations and activities may be slowed or halted by the COVID-19 pandemic; the likelihood of our clinical programs being executed on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize the intended benefits of collaborations with partners; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; our ability to maintain and service our loan facility with Pontifax and Kreos; general business, operational, financial and


accounting risks; and risks related to litigation and disputes with third parties. 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.

Cautionary Note on Future Updates

The statements contained in this press release reflect our current views with respect to future events, which may change significantly as the global consequences of the COVID-19 pandemic rapidly develop. Accordingly, we do not undertake and specifically disclaim any obligation to update any forward-looking statements.

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:
Cherilyn Cecchini, MD
LifeSci Communications
T: +1 646 876 5196
ccecchini@lifescicomms.com


Financial Tables

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

June 30, 

December 31, 

2021

2020

€ 1,000

€ 1,000

Assets

  

  

Current assets

  

  

Cash and cash equivalents

139,442

75,838

Prepayments and other receivables

3,761

3,762

Social securities and other taxes

381

421

Total current assets

143,584

80,021

Property, plant and equipment

17,928

18,601

Investments in associates

224

107

Investments in financial assets

621

Total assets

162,357

98,729

Equity and liabilities

  

  

Equity

  

Equity attributable to owners of the Company

118,106

57,091

Non-controlling interests

(563)

(545)

Total equity

117,543

56,546

Current liabilities

  

  

Borrowings

1,562

1,135

Lease liabilities

1,383

1,260

Derivative financial instruments

1,617

839

Trade payables

276

221

Current income tax liability

Social securities and other taxes

127

22

Pension premiums

6

Deferred income

1,659

700

Other current liabilities

5,750

6,118

Total current liabilities

12,374

10,301

Borrowings

16,972

16,189

Lease liabilities

15,468

15,693

Total liabilities

44,814

42,183

Total equity and liabilities

162,357

98,729


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

Six month period

ended June 30, 

 

ended June 30, 

    

2021

2020

 

2021

2020

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Revenue

243

243

Other income

411

8,674

552

8,937

Research and development costs

(9,735)

(8,587)

(18,640)

(21,412)

General and administrative costs

(4,122)

(3,446)

(7,461)

(7,364)

Total operating costs

(13,857)

(12,033)

(26,101)

(28,776)

  

  

  

  

Operating result

(13,203)

(3,359)

(25,306)

(19,839)

Finance income and expense

(2,464)

(697)

(2,757)

(161)

Results related to associates

(52)

(107)

(186)

Gain on recognition of financial asset

621

Results related to financial liabilities measured at fair value through profit or loss

(33)

(762)

  

  

  

  

Result before corporate income taxes

(15,700)

(4,108)

(28,311)

(20,186)

Income taxes

(53)

(11)

(60)

(11)

  

  

  

  

Result for the period

(15,753)

(4,119)

(28,371)

(20,197)

Other comprehensive income (foreign exchange differences on foreign operation)

(141)

(135)

255

121

  

  

  

  

Total comprehensive income

(15,894)

(4,254)

(28,116)

(20,076)

Result attributable to

  

  

  

  

Owners of the Company

(15,746)

(4,112)

(28,353)

(20,167)

Non-controlling interests

(7)

(7)

(18)

(30)

(15,753)

(4,119)

(28,371)

(20,197)

Total comprehensive income attributable to

Owners of the Company

(15,887)

(4,247)

(28,098)

(20,046)

Non-controlling interests

(7)

(7)

(18)

(30)

(15,894)

(4,254)

(28,116)

(20,076)

  

  

  

  

Share information

  

  

  

  

Weighted average number of shares outstanding1

66,147,153

50,021,194

58,521,508

49,963,614

Earnings per share attributable to owners of the Company (Euro per share)

Basic loss per share1

(0.24)

(0.08)

(0.48)

(0.40)

Diluted loss per share1

(0.24)

(0.08)

(0.48)

(0.40)

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

  

Number of
shares

  

Share
Capital

  

Share
Premium

  

Equity settled
Employee
Benefit
Reserve

  

Option
premium on
convertible
loan

  

Translation
Reserve

  

Accumulated
Deficit

  

Total

  

Non-
controlling
interests

  

Total
Equity

 

  

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Balance at January 1, 2020

 

53,975,838

2,159

287,214

16,551

151

(211,746)

94,329

(496)

93,833

Result for the period

 

(20,167)

(20,167)

(30)

(20,197)

Other comprehensive income

 

121

121

121

Recognition of share-based payments

 

2

283

4,542

4,827

4,827

Issuance of ordinary shares

100,902

2

270

272

272

Treasury shares transferred

(296,122)

Share options lapsed

(60)

60

Share options exercised

 

296,122

712

(458)

458

712

712

Balance at June 30, 2020

 

54,076,740

2,163

288,479

20,575

272

(231,395)

80,094

(526)

79,568

Balance at January 1, 2021

 

54,131,553

2,165

288,757

23,825

280

(189)

(257,747)

57,091

(545)

56,546

Result for the period

 

(28,353)

(28,353)

(18)

(28,371)

Other comprehensive income

 

255

255

255

Recognition of share-based payments

 

112,657

5

382

2,719

3,106

3,106

Issuance of ordinary shares

16,508,475

660

84,594

85,254

85,254

Treasury shares transferred

(127,303)

Recognition of equity component of convertible loan

Share options lapsed

(160)

160

Share options exercised

243,189

753

(541)

541

753

753

 

  

  

  

  

  

  

  

  

  

  

Balance at June 30, 2021

 

70,868,571

2,830

374,486

25,843

280

66

(285,399)

118,106

(563)

117,543


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

Three month period 

Six month period 

ended June 30, 

 

ended June 30, 

    

2021

2020

2021

2020

€ 1,000

€ 1,000

€ 1,000

€ 1,000

Cash flows from operating activities

  

  

  

  

Net result

(15,753)

(4,119)

(28,371)

(20,197)

Adjustments for:

— Depreciation

602

530

1,233

1,052

— Share-based compensation

1,471

1,802

2,719

4,672

— Other income

(8,423)

(8,423)

— Financial income and expenses

2,464

696

2,757

161

— Results related to associates

52

107

186

— Gain on recognition of financial asset

(621)

— Results related to financial liabilities measured at fair value through profit or loss

33

762

— Net foreign exchange gain / (loss)

(141)

(135)

255

121

— Income tax expenses

53

11

60

11

Changes in working capital

1,915

(918)

567

(3,119)

Cash used in operations

(9,356)

(10,504)

(20,532)

(25,536)

  

  

  

  

Corporate income tax paid

(53)

(11)

(60)

(11)

Interest received

5

62

5

91

Interest paid

(575)

(34)

(1,153)

(38)

  

  

  

  

Net cash used in operating activities

(9,979)

(10,487)

(21,740)

(25,494)

  

  

  

  

Cash flow from investing activities

Purchases of property, plant and equipment

(52)

(344)

(84)

(542)

  

  

  

  

Net cash used in investing activities

(52)

(344)

(84)

(542)

  

  

  

  

Cash flow from financing activities

  

  

  

  

Proceeds from issuance of shares, net of transaction costs

82,601

85,254

Proceeds from exercise of share options

185

243

753

712

Proceeds from borrowings

569

289

569

579

Proceeds from convertible loans

65

65

Repayment of lease liability

(14)

(105)

(250)

(307)

  

  

  

  

Net cash generated by financing activities

83,341

492

86,326

1,049

  

  

  

  

Net increase (decrease) in cash and cash equivalents

73,310

(10,339)

64,502

(24,987)

  

  

  

  

Currency effect cash and cash equivalents

(1,746)

(583)

(898)

178

Cash and cash equivalents, at beginning of the period

67,878

98,063

75,838

111,950

  

  

  

  

Cash and cash equivalents at the end of the period

139,442

87,141

139,442

87,141