UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

Current Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 11, 2020

 

MeiraGTx Holdings plc

(Exact name of registrant as specified in its charter)

 

 

450 East 29th Street, 14th Floor

New York, NY 10016

(Address of principal executive offices) (Zip code)

 

(646) 860‑7985

 (Registrant’s telephone number, including area code)

 

Not applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b‑2 of the Securities Exchange Act of 1934 (§240.12b‑2 of this chapter). 

 

Emerging growth company ☒ 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 

 

Item 2.02.           Results of Operations and Financial Condition.

On March 11, 2020 MeiraGTx Holdings plc (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2019. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8‑K and is incorporated herein by reference.

The information in this Current Report on Form 8‑K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01.          Financial Statements and Exhibits.

(d)        Exhibits.

 

SIGNATURE

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 hereunto duly authorized.

 

MeiraGTx Reports Full Year 2019 Financial Results

LONDON and NEW YORK, March 11,  2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the full year ended December 31, 2019 and provided an update on recent progress.

“During 2019,  the MeiraGTx team reached meaningful milestones,  including the initiation of two new clinical trials and our entry into a collaboration with Janssen to develop and commercialize our pipeline of inherited retinal disease treatments,”  said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.  “We have treated patients across five gene therapy clinical trials in the last year and remain committed to developing cutting-edge science that we can translate into treatments for patients affected by severe diseases. Over the next year,  we expect to move inherited retinal disease programs into late-stage studies, share preliminary data from our xerostomia program and file an IND to initiate the next clinical study of AAV-GAD for Parkinson’s disease.”

As of December 31, 2019,  MeiraGTx had cash and cash equivalents of approximately $227.4 million. The Company believes this capital will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

Recent Clinical Development Highlights and Anticipated 2020 Milestones

AAV-AQP1 for the treatment of Grade 2/3 Radiation-Induced Xerostomia:

Janssen-partnered investigational gene therapies for the treatment of inherited retinal diseases:

AAV-GAD for the treatment of Parkinson’s Disease:

AAV-RPE65 for the treatment of RPE65-Associated Retinal Dystrophy:

For more information related to our clinical trials, please visit www.clinicaltrials.gov

Recent Corporate Development Highlights and Anticipated 2020 Milestones

Second Viral Vector Manufacturing Facility and Plasmid Production Facility

Expanding Clinical, Regulatory, Manufacturing, MSAT and Preclinical Development Teams

Financial Results

Cash and cash equivalents were $227.4 million as of December 31, 2019, compared to  $68.1 million as of December 31, 2018.

Research and development expenses were $24.9  million for the year ended December 31, 2019, compared to $33.6 million for the year ended December 31, 2018. The decrease of $8.7 million was primarily due to research funding provided to us under the Janssen collaboration agreements in the amount of $27.9 million and an increase in the research and development credit in the United Kingdom of $8.6 million. These were partially offset by increases in costs related to our ocular and xerostomia clinical trials, clinical trial material manufacturing, restructuring of certain licenses, payroll, share-based compensation and rent.

General and administrative expenses were $46.7 million for the year ended December 31, 2019, compared to $44.5 million for the year ended December 31, 2018. The increase of $2.2 million was primarily due to increases in legal fees, rent, insurance, consulting fees, travel expenses, director fees and other general and administrative expenses, which was partially offset by decreases in share-based compensation and payroll.

Foreign currency gain was $3.2 million for the year ended December 31, 2019 compared to a loss of $3.8 million for the year ended December 31, 2018. The change of $7.6 million was primarily due to a strengthening of the pound sterling against the U.S. dollar in 2019.

Net loss attributable to ordinary shareholders for the year ended December 31, 2019 was $54.8  million, or $1.65 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $84.7 million, or $4.47 basic and diluted net loss per ordinary share for the year ended December 31, 2018.

About MeiraGTx

MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring

and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit www.meiragtx.com.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated 2020 milestones regarding our pre-clinical and clinical data and reporting of such data and the timing of results of data, as well as statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “should,” “anticipate” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, acquire additional capital, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards;  litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10‑K for the year ended December 31, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:

MeiraGTx

Elizabeth Broder

(646) 860‑7983

Investors@meiragtx.com 

 

or

 

Media:

W2O pure

Christiana Pascale

(212) 267‑6722

cpascale@purecommunications.com

 

MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

 

MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS