SECURITIES AND EXCHANGE COMMISSION
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Results of Operations and Financial Condition.
On August 11, 2021, MeiraGTx Holdings plc (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. 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.
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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.
Date: August 11, 2021
MEIRAGTX HOLDINGS PLC
/s/ Richard Giroux
Chief Financial Officer and Chief Operating Officer
MeiraGTx Reports Second Quarter 2021 Financial and Operational Results
LONDON and NEW YORK, August 11, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the second quarter ended June 30, 2021 and provided an update on recent progress.
“As we move into the second half of 2021, we are enthusiastic about the progress of our clinical programs and our gene regulation technology,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “Our leading position in XLRP has been strengthened as we head into our phase 3 pivotal trial for this large unmet need. We also remain on track to complete enrollment in our Phase 1 AQUAx study in grade 2/3 radiation-induced xerostomia this year and file our IND for AAV-GAD for Parkinson’s Disease.”
Dr. Forbes continued, “In a testament to the quality and expertise of our manufacturing team at MeiraGTx, we anticipate having at least six different clinical programs using material made and released from our cGMP facilities in the next 12 months. Our proprietary process and end-to-end capabilities have allowed us to successfully manufacture products using multiple capsids and genes across ocular, neurodegenerative, and salivary gland programs.”
As of June 30, 2021, MeiraGTx had cash and cash equivalents of approximately $172.6 million, as well as approximately $18.0 million due in receivables from development partner Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.
The Company believes it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2023.
Anticipated Upcoming Milestones and Corporate Activities
Initiate, with Janssen, the Phase 3 Lumeos clinical trial evaluating AAV-RGPR as a treatment for patients with X-Linked retinitis pigmentosa (XLRP) in the second half of 2021.
Initiate a Phase 3 pivotal trial of AAV-RPE65 for patients with RPE65-associated retinal dystrophy in the second half of 2021.
Complete enrollment of the Phase 1 AQUAx trial of AAV-AQP1 for the treatment for Grade 2/3 radiation-induced xerostomia in the second half of 2021.
File Investigational New Drug (IND) application for AAV-GAD for the treatment of Parkinson’s Disease in the third quarter of 2021.
Present in-vivo data from the Company’s riboswitch gene regulation platform at R&D day demonstrating regulation of multiple therapeutic targets in multiple tissues in the fourth quarter of 2021. Data from the Company’s proprietary promoter engineering platforms will also be presented.
Advance, with Janssen, development of AAV-CNGB3 and AAV-CNGA3 for the treatment of achromatopsia (ACHM) associated with mutations in the CNGB3 and CNGA3 genes to late-stage clinical trials.
Continue to progress several pre-clinical programs towards INDs in 2022.
For more information related to our clinical trials, please visit www.clinicaltrials.gov
License revenue was $5.1 million for the quarter ended June 30, 2021, compared to $2.5 million for the quarter ended June 30, 2020. The increase represents increased amortization of the $100.0 million upfront payment that the Company received in March 2019 from its collaboration agreement with Janssen.
General and administrative expenses were $10.4 million for the quarter ended June 30, 2021, compared to $11.5 million for the quarter ended June 30, 2020. The decrease of $1.1 million was primarily due to a decrease in payroll and payroll related costs and share-based compensation due to certain restricted ordinary shares issued to certain members of senior management in June 2018 becoming fully vested in June 2020, legal and accounting fees and other office related costs. These decreases were partially offset by increases in rent and facilities costs and insurance costs.
Research and development expenses were $15.2 million for the quarter ended June 30, 2021, compared to $16.2 million for the quarter ended June 30, 2020. The decrease of $1.0 million was primarily due to a decrease for the non-cash acquisition costs in connection with the acquisition of Emrys Bio Inc. during the second quarter of 2020, and an increase in research funding provided under our collaboration agreement with Janssen. The decrease was partially offset by increases in costs related to our pre-clinical research and clinical trials, costs related to the manufacture of material for our clinical trials, payroll and payroll related costs due to the expansion of our clinical trials and manufacturing capabilities, share-based compensation, depreciation and other research and development costs.
Foreign currency gain was $0.4 million for the quarter ended June 30, 2021, compared to a loss of $0.4 million for the quarter ended June 30, 2020. The change in the amount of $0.8 million was primarily due to a weakening of the U.S. dollar against the pound sterling and euro during the three months ended June 30, 2021.
Net loss attributable to ordinary shareholders for the quarter ended June 30, 2021 was $20.1 million, or $0.46 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $25.4 million, or $0.69 basic and diluted net loss per ordinary share for the quarter ended June 30, 2020.
Cash and cash equivalents were $172.6 million as of June 30, 2021, compared to $194.8 million as of June 30, 2020.
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: ocular, including inherited retinal diseases and large degenerative 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 2021 milestones regarding our pre-clinical and clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “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, raise 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; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, 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.
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
For the Three- Month Periods Ended June 30,
For the Six- Month Periods Ended June 30,
License revenue - related party
General and administrative
Research and development
Total operating expenses
Loss from operations
Other non-operating income (expense):
Foreign currency gain (loss)
Other comprehensive (loss) income:
Foreign currency translation (loss) gain
Total comprehensive loss
Basic and diluted net loss per ordinary share
Weighted-average number of ordinary shares outstanding
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
Cash and cash equivalents
Accounts receivable - related party
Tax incentive receivable
Other current assets
Total Current Assets
Property and equipment, net
Intangible assets, net
In-process research and development
Equity method and other investments
LIABILITIES AND SHAREHOLDERS' EQUITY
Lease obligations, current
Deferred revenue - related party, current
Other current liabilities
Total Current Liabilities
Deferred revenue - related party
Asset retirement obligations
Deferred income tax liability
COMMITMENTS (Note 10)
Ordinary Shares, $0.00003881 par value, 1,288,327,750
Capital in excess of par value
Accumulated other comprehensive loss
Total Shareholders' Equity
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY