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
May 18, 2016
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 Registrants 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 month period ended March 31, 2016 and furnished as Exhibit 99.2 to this Report on Form 6-K is a press release of ProQR Therapeutics N.V. dated May 18, 2016, announcing the Companys results for the three month period ended March 31, 2016.
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: May 18, 2016 | 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 month period ended March 31, 2016. | |
99.2 | Press Release of ProQR Therapeutics N.V. dated May 18, 2016, announcing the Companys results for the three month period ended March 31, 2016. |
Exhibit 99.1
PROQR THERAPEUTICS N.V.
Index to Unaudited Condensed Consolidated Financial Statements
PAGE | ||||
Unaudited Condensed Consolidated Statement of Financial Position as of March 31, 2016 and December 31, 2015 |
1 | |||
Unaudited Condensed Consolidated Statement of Comprehensive Loss for the Three Month Periods ended March 31, 2016 and 2015 |
2 | |||
Unaudited Condensed Consolidated Statement of Changes in Equity for the Three Month Periods ended March 31, 2016 and 2015 |
3 | |||
Unaudited Condensed Consolidated Statement of Cash Flows for the Three Month Periods ended March 31, 2016 and 2015 |
4 | |||
Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Unaudited Condensed Consolidated Financial Statements
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position
March 31, 2016 |
December 31, 2015 |
|||||||
1,000 | 1,000 | |||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
85,467 | 94,865 | ||||||
Prepayments and other receivables |
2,478 | 1,948 | ||||||
Social securities and other taxes |
533 | 956 | ||||||
|
|
|
|
|||||
Total current assets |
88,478 | 97,769 | ||||||
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|
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Property, plant and equipment |
2,790 | 2,199 | ||||||
Intangible assets |
128 | 141 | ||||||
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|
|||||
Total assets |
91,396 | 100,109 | ||||||
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|
|
|||||
Liabilities and shareholders equity |
||||||||
Current liabilities |
||||||||
Finance lease liabilities |
7 | 15 | ||||||
Trade payables |
1,026 | 885 | ||||||
Social securities and other taxes |
153 | 235 | ||||||
Pension premiums |
31 | 16 | ||||||
Deferred income |
| 144 | ||||||
Other current liabilities |
4,841 | 4,191 | ||||||
|
|
|
|
|||||
Total current liabilities |
6,058 | 5,486 | ||||||
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Finance lease liabilities |
| | ||||||
Borrowings |
5,142 | 4,824 | ||||||
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|
|
|
|||||
Total liabilities |
11,200 | 10,310 | ||||||
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|
|
|
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Shareholders equity |
||||||||
Shareholders equity |
80,196 | 89,799 | ||||||
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|
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|
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Total liabilities and shareholders equity |
91,396 | 100,109 | ||||||
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|
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 1
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 March 31, |
||||||||
2016 | 2015 | |||||||
1,000 | 1,000 | |||||||
Other income |
689 | 338 | ||||||
Research and development costs |
(6,898 | ) | (5,480 | ) | ||||
General and administrative costs |
(2,602 | ) | (1,603 | ) | ||||
|
|
|
|
|||||
Total operating costs |
(9,500 | ) | (7,083 | ) | ||||
|
|
|
|
|||||
Operating result |
(8,811 | ) | (6,745 | ) | ||||
Finance income and expense |
(1,387 | ) | 6,980 | |||||
Result before corporate income taxes |
(10,198 | ) | 235 | |||||
Income taxes |
| | ||||||
|
|
|
|
|||||
Net result attributable to equity holders of the Company |
(10,198 | ) | 235 | |||||
Other comprehensive income |
5 | | ||||||
Total comprehensive income (attributable to equity holders of the Company) |
(10,193 | ) | 235 | |||||
|
|
|
|
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Share information |
||||||||
Weighted average number of shares outstanding1 basic |
23,345,965 | 23,338,663 | ||||||
Weighted average number of shares outstanding1 diluted |
23,345,965 | 24,378,072 | ||||||
Earnings per share attributable to the equity holders of the Company (expressed in Euro per share) |
||||||||
Basic loss per share |
(0.44 | )1 | 0.01 | |||||
Diluted loss per share |
(0.44 | )1 | 0.01 |
The notes are an integral part of these condensed consolidated financial statements.
1. | For this period presented in these financial statements, the potential exercise of share options is not included in the diluted earnings per share calculation as the Company was loss-making in the period. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal in this period. |
PROQR THERAPEUTICS | DARWINWEG 24 | 2333 CR LEIDEN | THE NETHERLANDS | +31 88 166 7000 | WWW.PROQR.COM
PAGE 2
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 |
Translation Reserve |
Accumulated Deficit |
Total Equity |
||||||||||||||||||||||
1,000 | 1,000 | 1,000 | 1,000 | 1,000 | 1,000 | |||||||||||||||||||||||
Balance at January 1, 2015 |
23,338,154 | 934 | 123,581 | 687 | | (15,798 | ) | 109,404 | ||||||||||||||||||||
Net loss |
| | | | | 235 | 235 | |||||||||||||||||||||
Recognition of share-based payments |
| | | 288 | | | 288 | |||||||||||||||||||||
Share options exercised |
5,090 | 0 | 5 | | | | 5 | |||||||||||||||||||||
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Balance at March 31, 2015 |
23,343,244 | 934 | 123,586 | 975 | | (15,563 | ) | 109,932 | ||||||||||||||||||||
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Balance at January 1, 2016 |
23,345,965 | 934 | 123,595 | 1,899 | 1 | (36,630 | ) | 89,799 | ||||||||||||||||||||
Net loss |
| | | | | (10,198 | ) | (10,198 | ) | |||||||||||||||||||
Other comprehensive income |
| | | | 5 | | 5 | |||||||||||||||||||||
Recognition of share-based payments |
| | | 590 | | | 590 | |||||||||||||||||||||
Share options exercised |
| | | | | | | |||||||||||||||||||||
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Balance at March 31, 2016 |
23,345,965 | 934 | 123,595 | 2,489 | 6 | (46,828 | ) | 80,196 | ||||||||||||||||||||
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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 3
Unaudited Condensed Consolidated Financial Statements
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Cash Flows
Three month period ended March 31, |
||||||||
2016 | 2015 | |||||||
1,000 | 1,000 | |||||||
Cash flows from operating activities |
||||||||
Net result |
(10,193 | ) | 235 | |||||
Adjustments for: |
||||||||
Depreciation |
334 | 95 | ||||||
Share-based compensation |
590 | 288 | ||||||
Financial income and expenses |
1,387 | (6,980 | ) | |||||
Changes in working capital |
50 | 1,015 | ||||||
|
|
|
|
|||||
Cash used in operations |
(7,832 | ) | (5,347 | ) | ||||
|
|
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|
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Corporate income tax paid |
| | ||||||
Interest received/(paid) |
65 | 72 | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
(7,767 | ) | (5,275 | ) | ||||
|
|
|
|
|||||
Cash flow from investing activities |
||||||||
Purchases of intangible assets |
| | ||||||
Purchases of property, plant and equipment |
(502 | ) | (488 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(502 | ) | (488 | ) | ||||
|
|
|
|
|||||
Cash flow from financing activities |
||||||||
Proceeds from exercise of share options |
| 5 | ||||||
Proceeds from borrowings |
193 | | ||||||
Redemption of financial lease |
(8 | ) | (12 | ) | ||||
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|
|
|
|||||
Net cash generated by financing activities |
185 | (7 | ) | |||||
|
|
|
|
|||||
Net increase/(decrease) in cash and cash equivalents |
(8,084 | ) | (5,770 | ) | ||||
Currency effect cash and cash equivalents |
(1,314 | ) | 6,849 | |||||
Cash and cash equivalents, at beginning of the period |
94,865 | 112,736 | ||||||
|
|
|
|
|||||
Cash and cash equivalents at the end of the period |
85,467 | 113,815 | ||||||
|
|
|
|
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.
Notes to Unaudited Condensed Consolidated 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 Companys 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 Holding B.V. (100%); |
| ProQR Therapeutics I B.V. (100%); |
| ProQR Therapeutics II B.V. (100%); |
| ProQR Therapeutics III B.V. (100%); |
| ProQR Therapeutics IV B.V. (100%); |
| ProQR Therapeutics VI B.V. (100%); |
| ProQR Therapeutics I Inc. (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 34Interim 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 Companys annual financial statements for the year ended December 31, 2015. 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 Companys 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 Companys annual financial statements for the year ended December 31, 2015. New Standards and Interpretations, which became effective as of January 1, 2016, did not have a material impact on our 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
4. Critical Accounting Estimates and Judgments
In the application of the Companys 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 Companys 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 Companys annual financial statements for the year ended December 31, 2015 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 from the moment of listing, the Company uses the closing price of the ordinary shares on the previous business day as exercise price of the options granted.
The result of the share option valuations and the related compensation expense is dependent on the model and input parameters used. Even though Management considers the fair values reasonable and defensible based on the methodologies applied and the information available, others might derive a different fair value for the Companys 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. Managements judgment is that such convincing evidence is currently not sufficiently available and a deferred tax asset is therefore only recognized to the extent that the Company has sufficient taxable temporary differences.
(c) Grant income
Grants (to be) received are reflected in the balance sheet as other receivables or deferred income. At each balance sheet date, for grants approved, the Company estimates the associated costs incurred, the level of service performed and the progress of the associated projects. Based on this analysis grant income is recognized.
PROQR THERAPEUTICS | DARWINWEG 24 | 2333 CR LEIDEN | THE NETHERLANDS | +31 88 166 7000 | WWW.PROQR.COM
PAGE 6
Unaudited Condensed Consolidated Financial Statements
(d) Research and development expenditures
Research expenditures are currently not capitalized but are reflected in the income statement because the criteria for capitalization are not met. At each balance sheet date, the Company estimates the level of service performed by the vendors and the associated costs incurred for the services performed.
Although we do not expect the estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in reporting amounts that vary in any particular period.
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 Companys annual financial statements for the year ended December 31, 2015.
5. Cash and Cash Equivalents
At March 31, 2016, the Companys cash and equivalents were 85,467,000 as compared to 94,865,000 at December 31, 2015. 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.
6. Current liabilities
At March 31, 2016 and December 31, 2015, 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 March 31, 2016 increased compared to December 31, 2015 as a result of the increased level of research and development activities.
7. Borrowings
March 31, 2016 |
December 31, 2015 |
|||||||
1,000 | 1,000 | |||||||
Innovation credit |
4,421 | 4,228 | ||||||
Accrued interest on innovation credit |
721 | 596 | ||||||
|
|
|
|
|||||
Total borrowings |
5,142 | 4,824 | ||||||
|
|
|
|
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 Companys cystic fibrosis program. The credit was increased in the course of 2013 through 2016. The credit covers 35% of the costs incurred in respect of the program up to an initial maximum of 5.0 million through December 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 August 31, 2017, August 31, 2018 and August 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.
PROQR THERAPEUTICS | DARWINWEG 24 | 2333 CR LEIDEN | THE NETHERLANDS | +31 88 166 7000 | WWW.PROQR.COM
PAGE 7
Unaudited Condensed Consolidated Financial Statements
8. Shareholders equity
The authorized share capital of the Company amounting to 934,000 consists of 23,345,965 ordinary shares with a nominal value of 0.04 per share. All issued shares have been fully paid in cash.
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. 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 590,000 (2015: 288,000), of which 363,000 (2015: 198,000) was recorded in general and administrative costs and 227,000 (2015: 90,000) was recorded in research and development costs.
9. Other income
Other income increased to 689,000 for the quarter ended March 31, 2016 from 338,000 for the same period in 2015 and comprised income related to grants. Other income particularly increased in 2016 resulting from the 6 million grant from the European Commission (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 6,898,000 for the quarter ended March 31, 2016 from 5,480,000 for the same period in 2015 and 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. 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 amount to 2,602,000 for the quarter ended March 31, 2016 compared to 1,603,000 for the same period in 2015 primarily due to increased investments into our support organization.
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
PAGE 8
Exhibit 99.2
ProQR Therapeutics N.V. Press Release May 18, 2016 |
FINAL - FOR RELEASE
ProQR Announces Results for the First Quarter of 2016
LEIDEN, the Netherlands, May 18, 2016 ProQR Therapeutics N.V. (Nasdaq: PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis (CF) and Lebers congenital amaurosis Type 10 (LCA10), today announced results for the first quarter of 2016.
We continue to make great progress with our clinical development programs. Our first molecule, QR-010 for cystic fibrosis is in two active clinical trials and our second molecule, QR-110 for LCA10 is moving towards a first study in affected patients. We have also made a lot of progress in advancing our innovation pipeline, said Daniel de Boer, Chief Executive Officer of ProQR. This quarter we organized an inaugural R&D Day where we, along with key opinion leaders presented our deep pipeline of RNA based molecules which hold the promise of restoring normal protein function for a range of genetic diseases with high unmet medical needs.
Financial Highlights
At March 31, 2016, ProQR held cash and cash equivalents of 85.5 million, compared to 94.9 million at December 31, 2015. Net cash used in operating activities during the three month period ended March 31, 2016 was 7.8 million, compared to 5.3 million for the same period last year.
Research and development costs increased to 6.9 million for the quarter ended March 31, 2016 from 5.5 million for the same period last year and 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. The increase in expenses was primarily due to the clinical trial costs for QR-010 and clinic enabling studies for QR-110. The remainder represents increased investments in our other pipeline programs.
General and administrative costs increased to 2.6 million for the quarter ended March 31, 2016 from 1.6 million for the same period last year, primarily due to increased investments into our support organization. These costs include spend on the expansion of our lab and office facilities for the growing pipeline and headcount as well as increased spend on several compliance related activities, including internal controls for Sarbanes-Oxley (SOX).
Net result for the three month period ended March 31, 2016 was a 10.2 million loss or 0.44 per share, compared to a 0.2 million profit or 0.01 per share for the same period last year, which was driven primarily due to currency fluctuations. For further financial information for the period ending March 31, 2016, please refer to the financial statements appearing at the end of this release.
Corporate Highlights
| On March 14th the company organized an R&D Day in New York where ProQR executives as well as external key opinion leaders presented more information on ProQRs pipeline products including programs for cystic fibrosis, Lebers congenital amaurosis Type 10, Usher syndrome, Fuchs endothelial corneal dystrophy, dystrophic epidermolysis bullosa and Alzheimers disease. |
Subsequent events
| At the 2016 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) the company presented pre-clinical data for QR-110 for Lebers congenital amaurosis Type 10 (LCA10). QR-110 is a single-stranded, chemically modified RNA oligonucleotide designed to skip the cryptic splice site caused by the p.Cys998X mutation resulting in mRNA that codes for a wild-type CEP290 protein. Following intravitreal injection in vivo, QR-110 was demonstrated to reach the outer nuclear layer of the retina, the target tissue. QR-110 was also demonstrated to increase wild-type mRNA in cells with the p.Cys998X mutation. |
About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis and Lebers 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.
About QR-010
QR-010 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of the disease by repairing the mRNA defect encoded by the DF508 mutation in the CFTR gene of CF patients. The DF508 mutation is a deletion of three of the coding base pairs, or nucleotides, in the CFTR gene, which results in the production of a misfolded CFTR protein that does not function normally. QR-010 is designed to bind to the defective CFTR mRNA and guide the insertion of the three missing nucleotides, thus repairing the mRNA and subsequently producing wild-type, or normal CFTR protein. QR-010 is designed to be self-administered through a small, handheld aerosol delivery device, or nebulizer, in the form of a mist inhaled into the lungs. We believe this method could allow maximum exposure of QR-010 to the primary target organ, the lung, as well as significant exposure to other affected organs through systemic absorption into the blood. QR-010 has been granted orphan drug designation in the United States and the European Union. The QR-010 project has received funding from the European Unions Horizon 2020 research and innovation programme under grant agreement No. 633545.
About QR-110
QR-110 is a first-in-class oligonucleotide, designed to address the underlying cause of Lebers congenital amaurosis Type 10 due to the p.Cys998X mutation in the CEP290 gene. The p.Cys998X mutation is a substitution of one nucleotide in the pre-mRNA that leads to aberrant splicing of the mRNA and non-functional Cep290 protein. QR-110 is designed to restore wild-type CEP290 mRNA leading to the production of wild-type CEP290 protein by binding to the mutated location in the pre-mRNA causing normal splicing of the pre-mRNA. QR-110 is intended to be administered through intravitreal injections in the eye.
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 managements 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 QR-010 and QR-110, statements regarding our ongoing and planned discovery and development of product candidates, including those in our innovation pipeline, and statements regarding the Horizon 2020 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, except as required by law.
ProQR Therapeutics N.V.:
Sariette Witte
Investor Relations
T: +1 213 261 8891
ir@proqr.com
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Financial Position
March 31, 2016 |
December 31, 2015 |
|||||||
1,000 | 1,000 | |||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
85,467 | 94,865 | ||||||
Prepayments and other receivables |
2,478 | 1,948 | ||||||
Social securities and other taxes |
533 | 956 | ||||||
|
|
|
|
|||||
Total current assets |
88,478 | 97,769 | ||||||
|
|
|
|
|||||
Property, plant and equipment |
2,790 | 2,199 | ||||||
Intangible assets |
128 | 141 | ||||||
|
|
|
|
|||||
Total assets |
91,396 | 100,109 | ||||||
|
|
|
|
|||||
Liabilities and shareholders equity |
||||||||
Current liabilities |
||||||||
Finance lease liabilities |
7 | 15 | ||||||
Trade payables |
1,026 | 885 | ||||||
Social securities and other taxes |
153 | 235 | ||||||
Pension premiums |
31 | 16 | ||||||
Deferred income |
| 144 | ||||||
Other current liabilities |
4,841 | 4,191 | ||||||
|
|
|
|
|||||
Total current liabilities |
6,058 | 5,486 | ||||||
|
|
|
|
|||||
Finance lease liabilities |
| | ||||||
Borrowings |
5,142 | 4,824 | ||||||
|
|
|
|
|||||
Total liabilities |
11,200 | 10,310 | ||||||
|
|
|
|
|||||
Shareholders equity |
||||||||
Shareholders equity |
80,196 | 89,799 | ||||||
|
|
|
|
|||||
Total liabilities and shareholders equity |
91,396 | 100,109 | ||||||
|
|
|
|
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 March 31, |
||||||||
2016 | 2015 | |||||||
1,000 | 1,000 | |||||||
Other income |
689 | 338 | ||||||
Research and development costs |
(6,898 | ) | (5,480 | ) | ||||
General and administrative costs |
(2,602 | ) | (1,603 | ) | ||||
|
|
|
|
|||||
Total operating costs |
(9,500 | ) | (7,083 | ) | ||||
|
|
|
|
|||||
Operating result |
(8,811 | ) | (6,745 | ) | ||||
Finance income and expense |
(1,387 | ) | 6,980 | |||||
Result before corporate income taxes |
(10,198 | ) | 235 | |||||
Income taxes |
| | ||||||
|
|
|
|
|||||
Net result attributable to equity holders of the Company |
(10,198 | ) | 235 | |||||
Other comprehensive income |
5 | | ||||||
Total comprehensive income (attributable to equity holders of the Company) |
(10,193 | ) | 235 | |||||
|
|
|
|
|||||
Share information |
||||||||
Weighted average number of shares outstanding1 basic |
23,345,965 | 23,338,663 | ||||||
Weighted average number of shares outstanding1 diluted |
23,345,965 | 24,378,072 | ||||||
Earnings per share attributable to the equity holders of the Company (expressed in Euro per share) |
||||||||
Basic loss per share |
(0.44 | )1 | 0.01 | |||||
Diluted loss per share |
(0.44 | )1 | 0.01 |
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 the period. 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
Number of shares |
Total Share Capital |
Share Premium |
Equity Settled Employee Benefit Reserve |
Translation Reserve |
Accumulated Deficit |
Total Equity |
||||||||||||||||||||||
1,000 | 1,000 | 1,000 | 1,000 | 1,000 | 1,000 | |||||||||||||||||||||||
Balance at January 1, 2015 |
23,338,154 | 934 | 123,581 | 687 | | (15,798 | ) | 109,404 | ||||||||||||||||||||
Net loss |
| | | | | 235 | 235 | |||||||||||||||||||||
Recognition of share-based payments |
| | | 288 | | | 288 | |||||||||||||||||||||
Share options exercised |
5,090 | 0 | 5 | | | | 5 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at March 31, 2015 |
23,343,244 | 934 | 123,586 | 975 | | (15,563 | ) | 109,932 | ||||||||||||||||||||
Balance at January 1, 2016 |
23,345,965 | 934 | 123,595 | 1,899 | 1 | (36,630 | ) | 89,799 | ||||||||||||||||||||
Net loss |
| | | | | (10,198 | ) | (10,198 | ) | |||||||||||||||||||
Other comprehensive income |
| | | | 5 | | 5 | |||||||||||||||||||||
Recognition of share-based payments |
| | | 590 | | | 590 | |||||||||||||||||||||
Share options exercised |
| | | | | | | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at March 31, 2016 |
23,345,965 | 934 | 123,595 | 2,489 | 6 | (46,828 | ) | 80,196 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROQR THERAPEUTICS N.V.
Unaudited Condensed Consolidated Statement of Cash Flows
Three month period ended March 31, |
||||||||
2016 | 2015 | |||||||
1,000 | 1,000 | |||||||
Cash flows from operating activities |
||||||||
Net result |
(10,193 | ) | 235 | |||||
Adjustments for: |
||||||||
Depreciation |
334 | 95 | ||||||
Share-based compensation |
590 | 288 | ||||||
Financial income and expenses |
1,387 | (6,980 | ) | |||||
Changes in working capital |
50 | 1,015 | ||||||
|
|
|
|
|||||
Cash used in operations |
(7,832 | ) | (5,347 | ) | ||||
|
|
|
|
|||||
Corporate income tax paid |
| | ||||||
Interest received/(paid) |
65 | 72 | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
(7,767 | ) | (5,275 | ) | ||||
|
|
|
|
|||||
Cash flow from investing activities |
||||||||
Purchases of intangible assets |
| | ||||||
Purchases of property, plant and equipment |
(502 | ) | (488 | ) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
(502 | ) | (488 | ) | ||||
|
|
|
|
|||||
Cash flow from financing activities |
||||||||
Proceeds from exercise of share options |
| 5 | ||||||
Proceeds from borrowings |
193 | | ||||||
Redemption of financial lease |
(8 | ) | (12 | ) | ||||
|
|
|
|
|||||
Net cash generated by financing activities |
185 | (7 | ) | |||||
|
|
|
|
|||||
Net increase/(decrease) in cash and cash equivalents |
(8,084 | ) | (5,770 | ) | ||||
Currency effect cash and cash equivalents |
(1,314 | ) | 6,849 | |||||
Cash and cash equivalents, at beginning of the period |
94,865 | 112,736 | ||||||
|
|
|
|
|||||
Cash and cash equivalents at the end of the period |
85,467 | 113,815 | ||||||
|
|
|
|