Form 6-K

 

 

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 19, 2015

 

 

PROQR THERAPEUTICS N.V.

 

 

Darwinweg 24

2333 CR 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  ¨

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 period ended June 30, 2015 and furnished as Exhibit 99.2 to this Report on Form 6-K is a press release of ProQR Therapeutics N.V. dated August 19, 2015, announcing the Company’s results for the three and six month period ended June 30, 2015.


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 19, 2015     By:  

/s/ Smital Shah

      Smital Shah
      Chief Financial Officer


INDEX TO EXHIBITS

 

Number

  

Description

99.1    Unaudited financial statements of ProQR Therapeutics N.V. for the three and six month period ended June 30, 2015.
99.2    Press Release of ProQR Therapeutics N.V. dated August 19, 2015, announcing the Company’s results for the three and six month period ended June 30, 2015.
EX-99.1

Exhibit 99.1

PROQR THERAPEUTICS N.V.

Index to Unaudited Condensed Consolidated Interim Financial Statements

 

     PAGE  

Unaudited Condensed Consolidated Statement of Financial Position as of June 30, 2015 and December 31, 2014

     1   

Unaudited Condensed Consolidated Statement of Comprehensive Loss for the Three Month and Six Month Periods ended June 30, 2015 and 2014

     2   

Unaudited Condensed Consolidated Statement of Changes in Equity for the Six Month Periods ended June 30, 2015 and 2014

     3   

Unaudited Condensed Consolidated Statement of Cash Flows for the Three Month and Six Month Periods ended June 30, 2015 and 2014

     4   

Notes to Unaudited Condensed Consolidated Financial Statements

     5   


PAGE 1

Unaudited Condensed Consolidated Financial Statements

 

PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Financial Position

 

 

    

June 30,

2015

    

December 31,

2014

 
     € 1,000      € 1,000  

Assets

     

Current assets

     

Cash and cash equivalents

     106,382         112,736   

Prepayments and other receivables

     1,704         735   

Social securities and other taxes

     744         426   

Total current assets

     108,830         113,897   

Property, plant and equipment

     2,037         1,187   

Intangible assets

     166         163   

Total assets

     111,033         115,247   

Liabilities and shareholders’ equity

     

Current liabilities

     

Finance lease liabilities

     29         34   

Trade payables

     893         1,247   

Social securities and other taxes

     4         341   

Pension premiums

     135         127   

Deferred income

     1,570         —     

Other current liabilities

     2,530         1,265   

Total current liabilities

     5,161         3,014   

Finance lease liabilities

     —           15   

Borrowings

     4,232         2,814   

Total liabilities

     9,393         5,843   

Shareholders’ equity

     

Shareholders’ equity

     101,640         109,404   

Total liabilities and shareholders’ equity

     111,033         115,247   
  

 

 

    

 

 

 

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

 

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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

ended June 30,

   

Six month period

ended June 30,

 
     2015     2014     2015     2014  

Other income

     748                  1,086        4   

Research and development costs

     (5,427     (3,272     (10,907     (4,537

General and administrative costs

     (1,777     (1,535     (3,380     (2,130
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs

     (7,204     (4,807     (14,287     (6,667
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating result

     (6,456     (4,807     (13,201     (6,663

Finance income and expense

     (2,168     11        4,812        (52

Result before corporate income taxes

     (8,624     (4,796     (8,389     (6,715

Income taxes

     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to equity holders of the Company

     (8,624     (4,796     (8,389     (6,715

Other comprehensive income

     —          —          —          —     

Total comprehensive loss (attributable to equity holders of the Company)

     (8,624     (4,796     (8,389     (6,715
  

 

 

   

 

 

   

 

 

   

 

 

 

Share information

        

Weighted average number of shares outstanding1

     23,343,253        6,458,345        23,340,971        6,462,838   

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

        

Basic loss per share1

     (0.37     (0.74     (0.36     (1.04

Diluted loss per share1

     (0.37     (0.74     (0.36     (1.04

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

 

1. For the periods presented in these financial statements, the potential exercise of share options and the conversion of preferred shares into ordinary shares in 2014 are 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.

 

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PAGE 3

Unaudited Condensed Consolidated Financial Statements

 

PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Changes in Equity

 

 

    

 

Number of shares

     Total
Share
Capital
    Share
Premium
    Equity
Settled
Employee
Benefit
Reserve
     Accumulated
Deficit
    Total
Equity
 
     Ordinary     Preferred              
                  € 1,000     € 1,000     € 1,000      € 1,000     € 1,000  

Balance at January 1, 2014

     6,108,152                   59        3,482        41         (3,671     (89

Net loss

     —          —           —          —          —           (6,715     (6,715

Recognition of share-based payments

     —          —           —          —          228         —          228   

Shares issued in the period

     865,336        8,265,179         90        42,704        —           —          42,794   

Treasury shares issued

     (525,513     —           (5     (2,191     —           —          (2,196
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2014

     6,447,975        8,265,179         144        43,995        269         (10,386     34,022   

Balance at January 1, 2015

     23,338,154                   934        123,581        687         (15,798     109,404   

Net loss

     —          —           —          —          —           (8,389     (8,389

Recognition of share-based payments

     —          —           —          —          619         —          619   

Share options exercised

     5,217        —           0        6        —           —          6   
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2015

     23,343,371        —           934        123,587        1,306         (24,187     101,640   
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

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

 

PROQR THERAPEUTICS  |  DARWINWEG 24  |  2333 CR LEIDEN  |   THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM


PAGE 4

Unaudited Condensed Consolidated Financial Statements

 

PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Cash Flows

 

     Three month period
ended June 30,
    Six month period
ended June 30,
 
     2015     2014     2015     2014  
     € 1,000     € 1,000     € 1,000     € 1,000  

Cash flows from operating activities

        

Net loss

     (8,624     (4,796     (8,389     (6,715

Adjustments for:

        

— Depreciation

     117        22        212        39   

— Share-based compensation

     331        124        619        228   

— Financial income and expenses

     2,168        (11     (4,812     52   

Changes in working capital

     (16     1,399        999        1,200   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash used in operations

     (6,024     (3,262     (11,371     (5,196
  

 

 

   

 

 

   

 

 

   

 

 

 

Corporate income tax paid

     —          —          —          —     

Interest received/(paid)

     105        21        177        19   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (5,919     (3,241     (11,194     (5,177
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash flow from investing activities

        

Purchases of property, plant and equipment

     (549     (94     (1,037     (250

Purchases of intangible assets

     (28     —          (28     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (577     (94     (1,065     (250
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash flow from financing activities

        

Proceeds from issuance of shares, net of transaction costs

     —          37,842        —          37,842   

Proceeds from exercise of share options

     1        —          6        —     

Proceeds from borrowings

     1,254        1,666        1,254        1,666   

Redemption of financial lease

     (8     (2     (20     (17
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash generated by financing activities

     1,247        39,506        1,240        39,491   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net increase/(decrease) in cash and cash equivalents

     (5,249     36,171        (11,019     34,064   

Currency effect cash and cash equivalents

     (2,184     —          4,665        —     

Cash and cash equivalents, at beginning of the period

     113,815        2,022        112,736        4,129   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     106,382        38,193        106,382        38,193   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

PROQR THERAPEUTICS  |  DARWINWEG 24  |  2333 CR LEIDEN  |   THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM


PAGE 5

Unaudited Condensed Consolidated Financial Statements

 

PROQR THERAPEUTICS N.V.

Notes to Unaudited Condensed Consolidated Interim Financial Statements

1. General information

ProQR Therapeutics N.V., or “ProQR” or the “Company”, is a development stage company 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 has been 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 Darwinweg 24, 2333 CR Leiden, the Netherlands.

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

 

  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%);

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.

2. Significant Accounting Policies

These condensed consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”), in particular 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, 2014. 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.

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, 2014. New Standards and Interpretations, which became effective as of January 1, 2015, did not have a material impact on our condensed consolidated financial statements.

 

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PAGE 6

Unaudited 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, 2014 for the assumptions used in those estimates. The value of the underlying shares 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 on September 17, 2014, the Company used the opening price of the Company’s stock on September 18, 2014, the first day of trading of the Company’s stock on the Nasdag Global Market, which amounted to US$13.00 (€10.03) as the value of its ordinary shares.

For all options granted subsequent to the initial public offering, the Company uses the closing price of the ordinary shares on the previous business day as the 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) 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 vary in any particular period.

 

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PAGE 7

Unaudited Condensed Consolidated Financial Statements

 

The condensed consolidated financial statements do not include all disclosures for critical accounting estimates and judgments that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual financial statements for the year ended December 31, 2014.

5. Cash and Cash Equivalents

At June 30, 2015, the Company’s cash and equivalents were € 106,382,000 as compared to €112,736,000 at December 31, 2014. A significant portion 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. Bank deposits are convertible into cash upon request of the Company.

6. Current liabilities

At June 30, 2015 and December 31, 2014, the other current liabilities consisted principally of accruals for services provided by vendors not yet billed and other miscellaneous liabilities. The accrued liabilities as at June 30, 2015 increased significantly compared to December 31, 2014 as it includes deferred income resulting from receipt of the first installment of the € 6 million grant from the European Committee (EC) under the Horizon 2020 program to finance the clinical development of QR-010.

7. Borrowings

 

    

June 30,

2015

    

December 31,

2014

 
     € 1,000      € 1,000  

Innovation credit

     3,842         2,588   

Accrued interest on innovation credit

     390         226   

Total borrowings

     4,232         2,814   
  

 

 

    

 

 

 

Innovation credit (“Innovatiekrediet”)

On June 1, 2012, ProQR was awarded an Innovation credit by the Dutch government, through its agency RVO (previously: “AgentschapNL”) of the Ministry of Economic Affairs, for the Company’s cystic fibrosis program. The credit was increased in the course of 2013 and 2014. The credit covers 35% of the costs incurred in respect of the program up to an initial maximum of € 5.0 million through March 31, 2016.

The credit is interest-bearing at a rate of 10% per annum. The credit, including accrued interest, is repayable in three instalments on January 31, 2017, January 31, 2018 and January 31, 2019, depending on the technical success of the program.

The assets which are co-financed with the granted innovation credit are subject to a right of pledge for the benefit of RVO.

8. Shareholders’ equity

The authorized share capital of the Company amounting to € 934,000 consists of 23,343,371 ordinary shares with a nominal value of € 0.04 per share. All issued shares have been fully paid in cash.

On September 15, 2014, the general meeting of shareholders of the Company resolved to approve and effect a capital reorganization, including a share split and bonus share issuance. The combined effect of the share split and bonus share issuance was a 101.804232-for-1 share split of the outstanding ordinary and preferred shares held by the Company’s shareholders. This share split became effective on September 15, 2014.

 

PROQR THERAPEUTICS  |  DARWINWEG 24  |  2333 CR LEIDEN  |   THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM


PAGE 8

Unaudited Condensed Consolidated Financial Statements

 

All share, per-share and related information presented in the comparative figures of these condensed consolidated financial statements and accompanying footnotes have been retroactively adjusted, where applicable, to reflect the impact of the share split.

On September 18, 2014, the Company was listed at the NASDAQ Global Market under ticker symbol PRQR. In connection with this listing, the Company issued a total of 8,625,000 ordinary shares against the initial public offering price of $ 13.00, resulting in gross proceeds of $ 112,125,000 (€ 87,202,000). The number of shares issued includes the exercise of the overallotment option granted to the underwriters. The net proceeds raised in the offering amounted to € 80,376,000, net of € 8,589,000 of underwriting discounts and offering expenses, of which € 6,826,000 was processed through share premium and € 1,763,000 was included in the statement of comprehensive loss as general and administrative costs.

All of the issued preferred shares were converted into the Company’s ordinary shares. The conversion rate for the preferred shares was one-to-one, adjusted for the stock splits.

Treasury shares

All treasury shares presented in the statement of changes in equity relate to ordinary shares that have legally been issued, but that are within control of the Company. Therefore, these shares are presented as treasury shares.

Share options

The Company operates an equity-settled share-based compensation plan which was introduced in 2013. The supervisory board may grant options to employees, members of the supervisory board, members of the management board and consultants. The quarterly compensation expenses included in operating costs for this plan were € 331,000 (2014: € 124,000), of which € 227,000 (2014: € 70,000) was recorded in general and administrative costs and € 104,000 (2014: € 54,000) was recorded in research and development costs.

9. Other income

Other income increased to € 748,000 for the quarter ended June 30, 2015 from nil for the same period in 2014 and comprised income related to grants. Other income particularly increased in the second quarter resulting from the € 6 million grant from the European Committee (EC) under the Horizon 2020 program to finance the clinical development of QR-010.

10. Research and development costs

Research and development costs increased to € 5,427,000 for the quarter ended June 30, 2015 from € 3,272,000 for the same period in 2014 and comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, license and intellectual property costs and other allocated costs. The increase in expenses was primarily due to the advancement of QR-010 into clinical development and QR-110 from research into development as well as increased investments in our other research programs.

11. General and administrative costs

General and administrative costs increased to € 1,777,000 for the quarter ended June 30, 2015 from € 1,535,000 for the same period in 2014. The increase is primarily due to the growth of the G&A functions to support the strong overall growth of the Company, as well as costs directly and indirectly associated with our NASDAQ listing.

 

PROQR THERAPEUTICS  |  DARWINWEG 24  |  2333 CR LEIDEN  |   THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM


PAGE 9

Unaudited Condensed Consolidated Financial Statements

 

12. 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.

13. Events after balance sheet date

No significant events have occurred after balance sheet date.

 

PROQR THERAPEUTICS  |  DARWINWEG 24  |  2333 CR LEIDEN  |   THE NETHERLANDS  |  +31 88 166 7000  |  WWW.PROQR.COM

EX-99.2

Exhibit 99.2

 

ProQR Therapeutics N.V.

Press Release August 19, 2015

     LOGO     

ProQR Announces Results for the Second Quarter of 2015

LEIDEN, the Netherlands, August 19, 2015 — ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe diseases such as cystic fibrosis (CF) and Leber’s congenital amaurosis (LCA), today announced results for the second quarter of 2015.

“The second quarter of 2015 was an important quarter for our Company. Since inception of the Company, three years ago, employees and external partners have worked very hard to achieve the start of our first clinical trial, so we were pleased to announce that we have started enrollment of patients in our first clinical trial to test our drug candidate QR-010 in patients with cystic fibrosis,” said Daniel de Boer, Chief Executive Officer of ProQR. “I am happy and grateful that we have accomplished this important milestone and want to thank everyone who was involved.”

Financial Highlights

As of June 30, 2015, ProQR held cash and cash equivalents of €106.4 million, compared to €113.8 million at March 31, 2015. Net cash used in operating activities during the three month period ended June 30, 2015 was €5.9 million, compared to €3.2 million for the same period last year.

Research and development costs increased to €5.4 million for the quarter ended June 30, 2015 from €3.3 million for the same period in 2014 and comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, license and intellectual property costs and other allocated costs. The increase in expenses was primarily due to advancement of QR-010 into clinical development and QR-110 from research into development as well as increased investment into our RNA based therapeutics pipeline.

General and administrative costs increased to €1.8 million for the quarter ended June 30, 2015 from €1.5 million for the same period in 2014. The increase is primarily due to the growth of the G&A functions to support the strong overall growth of the company, as well as costs directly and indirectly associated with our NASDAQ listing.

Net result for the three month period ended June 30, 2015 was a €8.6 million loss or €0.37 per share, compared to a €4.8 million loss or €0.74 per share for the same period in 2014. For further financial information for the period ending June 30, 2015, please refer to the financial statements appearing at the end of this release.

Corporate Highlights

 

   

Enrollment has started in study PQ-010-001, a global Phase 1b clinical study of QR-010, a novel investigational RNA therapeutic designed to repair the genetic mutation in the mRNA of cystic fibrosis (CF) patients due to the DF508 mutation. PQ-010-001 is a Phase 1b randomized, double-blind, placebo-controlled, 28-day study to be conducted in approximately 20 centers worldwide. This first-in-human study will evaluate the safety, tolerability and pharmacokinetics of single and multiple

 

ProQR Therapeutics N.V.  |  Darwinweg 24, 2333 CR Leiden, The Netherlands  |  +31 88 166 7000  |  info@proqr.com  |  www.proqr.com


 

ascending doses of inhaled QR-010 in 64 CF patients homozygous (carrying two copies) of the DF508 mutation. As exploratory efficacy endpoints this study will also assess sweat chloride, weight gain, CFQ-R Respiratory Symptom Score and lung function, measured by FEV1.

 

    The Phase 1b trial will be conducted in parallel with a proof-of-concept Nasal Potential Difference (NPD) study of QR-010 that will enroll 16 CF patients that are either DF508 homozygous or compound heterozygous (one copy of the DF508 plus one other CF disease causing mutation) for the mutation and is expected to begin in 3Q2015.

 

    The Company selected the product candidate in our second program, QR-110 for the treatment of Leber’s congenital amaurosis (LCA), the most common genetic blindness in childhood. QR-110 is an RNA oligonucleotide designed to repair the pCys998X mutation that results in abnormal CEP290 protein in LCA patients. QR-110 is the first program to be added to the pipeline behind the CF program from ProQR’s internal innovation (discovery) unit and the Company intends to start the first clinical trial of QR-110 in patients in 2016.

 

    The European Committee (EC) through its Horizon 2020 program awarded ProQR and its academic partners a grant of €6 million to support the clinical development of QR-010. Horizon 2020 is one of the largest research and innovation programs in the European Union with nearly €80 billion in available funding for qualified projects from 2014 to 2020. Under the Horizon 2020, the EC works closely with the European Research Council, the European Institute of Innovation and Technology and EURATOM and evaluates projects on three key pillars of Excellent Science, Industrial Leadership and Societal Challenges.

 

    ProQR received an additional tranche of €1.2 million under the Innovation credit program or “Innovatiekrediet” by the Dutch government, through its agency RVO (previously: “AgentschapNL”) of the Ministry of Economic Affairs, for the cystic fibrosis development program. The credit covers 35% of the costs incurred for the program up to an initial maximum of € 5.0 million through November 30, 2015. The credit is interest-bearing at a rate of 10% per annum. The credit, including accrued interest, is repayable in three instalments on January 31, 2017, January 31, 2018 and January 31, 2019, depending on the technical success of the program.

About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe diseases such as cystic fibrosis and Leber’s congenital amaurosis. 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. 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. These forward-looking statements include, but are not limited to, statements regarding the initiation of clinical trials of QR-010 and QR-110, statements regarding our ongoing and planned discovery and development of product candidates, statements regarding the timing and availability of funding under the Horizon 2020 program and statements regarding the terms and conditions of funding under the Innovation credit program. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, manufacturing processes and facilities, regulatory oversight, product commercialization, intellectual property claims, and 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.

ProQR Therapeutics N.V.:

Smital Shah

Chief Financial Officer

T: +1 415 231 6431

ir@proqr.com

Media inquiries:

Gretchen Schweitzer

MacDougall Biomedical Communications

Direct: +49 172 861 8540

Main: +49 89 2424 3494

gschweitzer@macbiocom.com


PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Financial Position

 

 

    

June 30,

2015

    

December 31,

2014

 
     € 1,000      € 1,000  

Assets

     

Current assets

     

Cash and cash equivalents

     106,382         112,736   

Prepayments and other receivables

     1,704         735   

Social securities and other taxes

     744         426   

Total current assets

     108,830         113,897   

Property, plant and equipment

     2,037         1,187   

Intangible assets

     166         163   

Total assets

     111,033         115,247   

Liabilities and shareholders’ equity

     

Current liabilities

     

Finance lease liabilities

     29         34   

Trade payables

     893         1,247   

Social securities and other taxes

     4         341   

Pension premiums

     135         127   

Deferred income

     1,570         —     

Other current liabilities

     2,530         1,265   

Total current liabilities

     5,161         3,014   

Finance lease liabilities

     —           15   

Borrowings

     4,232         2,814   

Total liabilities

     9,393         5,843   

Shareholders’ equity

     

Shareholders’ equity

     101,640         109,404   

Total liabilities and shareholders’ equity

     111,033         115,247   
  

 

 

    

 

 

 


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

ended June 30,

   

Six month period

ended June 30,

 
     2015     2014     2015     2014  

Other income

     748        —          1,086        4   

Research and development costs

     (5,427     (3,272     (10,907     (4,537

General and administrative costs

     (1,777     (1,535     (3,380     (2,130
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs

     (7,204     (4,807     (14,287     (6,667
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating result

     (6,456     (4,807     (13,201     (6,663

Finance income and expense

     (2,168     11        4,812        (52

Result before corporate income taxes

     (8,624     (4,796     (8,389     (6,715

Income taxes

     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to equity holders of the Company

     (8,624     (4,796     (8,389     (6,715

Other comprehensive income

     —          —          —          —     

Total comprehensive loss (attributable to equity holders of the Company)

     (8,624     (4,796     (8,389     (6,715
  

 

 

   

 

 

   

 

 

   

 

 

 

Share information

        

Weighted average number of shares outstanding1

     23,343,253        6,458,345        23,340,971        6,462,838   

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

        

Basic loss per share1

     (0.37     (0.74     (0.36     (1.04

Diluted loss per share1

     (0.37     (0.74     (0.36     (1.04

 

1. For the periods presented in these financial statements, the potential exercise of share options and the conversion of preferred shares into ordinary shares in 2014 are 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.


PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Changes in Equity

 

 

    

 

Number of shares

     Total
Share
Capital
    Share
Premium
    Equity
Settled
Employee
Benefit
Reserve
     Accumulated
Deficit
    Total
Equity
 
     Ordinary     Preferred              
                  € 1,000     € 1,000     € 1,000      € 1,000     € 1,000  

Balance at January 1, 2014

     6,108,152        —           59        3,482        41         (3,671     (89

Net loss

     —          —           —          —          —           (6,715     (6,715

Recognition of share-based payments

     —          —           —          —          228         —          228   

Shares issued in the period

     865,336        8,265,179         90        42,704        —           —          42,794   

Treasury shares issued

     (525,513     —           (5     (2,191     —           —          (2,196
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2014

     6,447,975        8,265,179         144        43,995        269         (10,386     34,022   

Balance at January 1, 2015

     23,338,154        —           934        123,581        687         (15,798     109,404   

Net loss

     —          —           —          —          —           (8,389     (8,389

Recognition of share-based payments

     —          —           —          —          619         —          619   

Share options exercised

     5,217        —           0        6        —           —          6   
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 

Balance at June 30, 2015

     23,343,371        —           934        123,587        1,306         (24,187     101,640   
  

 

 

   

 

 

    

 

 

   

 

 

   

 

 

    

 

 

   

 

 

 


PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Cash Flows

 

     Three month period
ended June 30,
    Six month period
ended June 30,
 
     2015     2014     2015     2014  
     € 1,000     € 1,000     € 1,000     € 1,000  

Cash flows from operating activities

        

Net loss

     (8,624     (4,796     (8,389     (6,715

Adjustments for:

        

— Depreciation

     117        22        212        39   

— Share-based compensation

     331        124        619        228   

— Financial income and expenses

     2,168        (11     (4,812     52   

Changes in working capital

     (16     1,399        999        1,200   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash used in operations

     (6,024     (3,262     (11,371     (5,196
  

 

 

   

 

 

   

 

 

   

 

 

 

Corporate income tax paid

     —          —          —          —     

Interest received/(paid)

     105        21        177        19   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (5,919     (3,241     (11,194     (5,177
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash flow from investing activities

        

Purchases of property, plant and equipment

     (549     (94     (1,037     (250

Purchases of intangible assets

     (28     —          (28     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (577     (94     (1,065     (250
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash flow from financing activities

        

Proceeds from issuance of shares, net of transaction costs

     —          37,842        —          37,842   

Proceeds from exercise of share options

     1        —          6        —     

Proceeds from borrowings

     1,254        1,666        1,254        1,666   

Redemption of financial lease

     (8     (2     (20     (17
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash generated by financing activities

     1,247        39,506        1,240        39,491   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net increase/(decrease) in cash and cash equivalents

     (5,249     36,171        (11,019     34,064   

Currency effect cash and cash equivalents

     (2,184     —          4,665        —     

Cash and cash equivalents, at beginning of the period

     113,815        2,022        112,736        4,129   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     106,382        38,193        106,382        38,193