UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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 November 5, 2020, MeiraGTx Holdings plc (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2020. 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.
Exhibit No. |
| Description |
99.1 | Press release of MeiraGTx Holdings plc, dated November 5, 2020. |
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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.
Date: November 5, 2020 | ||
MEIRAGTX HOLDINGS PLC | ||
By: | /s/ Richard Giroux | |
Name: | Richard Giroux | |
Title: | Chief Financial Officer and Chief Operating Officer | |
3
Exhibit 99.1
MeiraGTx Reports Third Quarter 2020 Financial Results
- MeiraGTx preparing to initiate Phase 3 trial of AAV-RPGR
- Plasmid production facility expected to be completed year-end 2020
LONDON and NEW YORK, November 5, 2020 -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the third quarter ended September 30, 2020 and provided an update on recent clinical development and business progress.
“As we prepare to initiate our first pivotal trial, we continue to be encouraged by data emerging from our Phase 1/2 clinical trial of AAV-RPGR for the treatment of X-linked retinitis pigmentosa,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We continued to make significant progress this quarter advancing our programs, and we look forward to providing additional clinical updates through the end of the year.”
MeiraGTx and Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.
As of September 30, 2020, MeiraGTx had cash, cash equivalents and restricted cash of $179.3 million. In addition, the Company expects approximately $26.6 million in receivables from development partner Janssen in the next 90 days. MeiraGTx believes this capital will be sufficient to fund operating expenses and capital expenditure requirements into 2022.
Recent Clinical Development and Corporate Updates
AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa (XLRP)
| ● | Nine-month data from MeiraGTx’s ongoing Phase 1/2 clinical study (MGT009) of AAV-RPGR were presented at the EURETINA 2020 Virtual Meeting in October. Data at the nine-month time point continued to demonstrate significant, sustained vision improvement following treatment with AAV-RPGR in both the low (n=3) and intermediate (n=4) dose cohorts. |
| ● | Twelve-month data from the study will be presented at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting on November 13, 2020. |
| ● | MeiraGTx and development partner Janssen are preparing to initiate the pivotal Phase 3 Lumeos clinical trial of AAV-RPGR in patients with XLRP. |
AAV-AQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia
| ● | In response to the COVID-19 pandemic, MeiraGTx is working with clinical sites to enable continuity of the AQUAx clinical trial in accordance with local regulations and site policies. Monitoring of enrolled subjects continues and start up activities for new sites have resumed. |
| ● | MeiraGTx expects to report preliminary data from the first treatment cohort of the AQUAx trial by the end of 2020. |
AAV-GAD for the Treatment of Parkinson’s Disease:
| ● | MeiraGTx continues to expect to file an Investigational New Drug (IND) application in the first half of 2021 following the release of the clinical material manufactured at the Company’s London cGMP facility. |
Manufacturing and Supply Chain
| ● | Construction of MeiraGTx’s Shannon, Ireland manufacturing campus is progressing. The campus will house the Company’s first cGMP plasmid production facility and MeiraGTx’s second cGMP viral vector manufacturing facility. The Shannon campus will provide additional flexibility and large-scale capacity for clinical and commercial supply of MeiraGTx’s gene therapy product candidates. |
| ● | Construction and commissioning activity remain on track, with the plasmid facility expected to be completed at the end of 2020, and the viral vector facility expected to be completed by year-end 2021. Hiring of highly skilled bio-process engineering, manufacturing and quality professionals in Ireland has commenced with several new employees expected by the end of 2020. |
| ● | MeiraGTx’s cGMP viral vector manufacturing facility in London was re-certified in the second quarter of 2020 by the Medicines & Healthcare Products Regulatory Agency (MHRA). |
For more information related to our clinical trials, please visit www.clinicaltrials.gov
Financial Results
License revenue was $5.1 million for the quarter ended September 30, 2020, compared to $3.6 million for the quarter ended September 30, 2019. 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.
Research and development expenses were $4.6 million for the quarter ended September 30, 2020, compared to $4.6 million for the quarter ended September 30, 2019. Expenses primarily consisted of costs related to pre-clinical research and clinical trials, costs related to the manufacture of material for clinical trials, payroll and payroll related costs and share-based compensation, which were partially offset by research funding provided under our collaboration agreement with Janssen.
General and administrative expenses were $8.9 million for the quarter ended September 30, 2020, compared to $9.9 million for the quarter ended September 30, 2019. The decrease was primarily due to decreases in payroll and payroll related costs and travel costs, which were partially offset by increases in rent and facilities costs, insurance costs, legal and accounting fees and other office-related costs.
Foreign currency gain was $1.9 million for the quarter ended September 30, 2020, compared to a gain of $0.1 million for the quarter ended September 30, 2019. The increase was primarily due to a weakening of the U.S. dollar against the pound sterling.
Net loss attributable to ordinary shareholders for the quarter ended September 30, 2020 was $6.4 million, or $ (0.17) basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $10.5 million, or $(0.30) basic and diluted net loss per ordinary share for the quarter ended September 30, 2019.
Cash, cash equivalents and restricted cash were $179.3 million for the quarter ended September 30, 2020, compared to $253.3 million as of September 30, 2019.
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 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,” “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, 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 September 30, 2020, 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) Anderson
(646) 860-7983
elizabeth@meiragtx.com
or
Media:
W2O pure
Christiana Pascale
(212) 257-6722
cpascale@purecommunications.com
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| | For the Three-Month | | For the Nine-Month | ||||||||
| | Period Ended September 30, | | Period Ended September 30, | ||||||||
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| 2020 |
| 2019 |
| 2020 |
| 2019 | ||||
| | | | | | | | | | | | |
License revenue - related party | | $ | 5,091,832 | | $ | 3,582,586 | | $ | 11,775,113 | | $ | 6,349,222 |
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Operating expenses: | |
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| |
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|
General and administrative | |
| 8,896,111 | |
| 9,874,810 | |
| 32,199,515 | |
| 31,811,456 |
Research and development | |
| 4,626,085 | |
| 4,614,446 | |
| 28,911,490 | |
| 27,362,432 |
Total operating expenses | |
| 13,522,196 | |
| 14,489,256 | |
| 61,111,005 | |
| 59,173,888 |
Loss from operations | |
| (8,430,364) | |
| (10,906,670) | |
| (49,335,892) | |
| (52,824,666) |
Other non-operating income (expense): | |
|
| |
|
| |
|
| |
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|
Foreign currency gain | |
| 1,875,427 | |
| 115,470 | |
| 766,860 | |
| 3,117,047 |
Interest income | |
| 158,346 | |
| 959 | |
| 1,141,321 | |
| 40,686 |
Interest expense | |
| (35,136) | |
| (9,283) | |
| (103,147) | |
| (28,311) |
Loss before income taxes | |
| (6,431,727) | |
| (10,799,524) | |
| (47,530,858) | |
| (49,695,244) |
Benefit for income taxes | |
| — | |
| 338,670 | |
| — | |
| 430,060 |
Net loss | |
| (6,431,727) | |
| (10,460,854) | |
| (47,530,858) | |
| (49,265,184) |
Other comprehensive (loss) income: | |
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| |
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| |
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Foreign currency translation (loss) gain | |
| (4,121,227) | |
| 1,653,507 | |
| 342,289 | |
| 2,099,706 |
Total comprehensive loss | | $ | (10,552,954) | | $ | (8,807,347) | | $ | (47,188,569) | | $ | (47,165,478) |
Net loss | | $ | (6,431,727) | | $ | (10,460,854) | | $ | (47,530,858) | | $ | (49,265,184) |
Basic and diluted adjusted net loss per ordinary share | | $ | (0.17) | | $ | (0.30) | | $ | (1.29) | | $ | (1.53) |
Weighted-average number of ordinary shares outstanding | |
| 37,223,375 | |
| 34,663,623 | |
| 36,940,372 | |
| 32,111,733 |
See Notes to Condensed Consolidated Financial Statements
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
|
| September 30, |
| December 31, | ||
| | 2020 | | 2019 | ||
ASSETS |
| |
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| |
|
| | | | | | |
CURRENT ASSETS: |
| |
|
| |
|
Cash and cash equivalents | | $ | 179,084,386 | | $ | 227,233,384 |
Restricted cash | |
| 250,526 | |
| — |
Accounts receivable - related party | |
| 26,639,805 | |
| 23,337,377 |
Prepaid expenses | |
| 4,001,502 | |
| 4,464,085 |
Tax incentive receivable | |
| 7,087,253 | |
| 11,974,437 |
Other current assets | |
| 818,671 | |
| 1,970,585 |
| | | | | | |
Total Current Assets | |
| 217,882,143 | |
| 268,979,868 |
| | | | | | |
Property and equipment, net | |
| 34,820,814 | |
| 23,858,108 |
Security deposits | |
| 737,720 | |
| 951,138 |
In-process research and development | |
| 810,357 | |
| 777,655 |
Restricted cash | |
| — | |
| 123,376 |
Other assets | |
| 203,255 | |
| 195,053 |
Right-of-use assets | |
| 38,591,434 | |
| 29,002,448 |
| | | | | | |
| | | | | | |
TOTAL ASSETS | | $ | 293,045,723 | | $ | 323,887,646 |
| | | | | | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |
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CURRENT LIABILITIES: | |
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| |
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|
Accounts payable | | $ | 5,195,937 | | $ | 3,759,339 |
Accrued expenses | |
| 15,563,482 | |
| 18,083,757 |
Lease obligations, current | |
| 2,116,018 | |
| 1,674,210 |
Deferred revenue - related party, current | |
| 23,715,116 | |
| 25,678,515 |
Other current liabilities | |
| 17,639 | |
| — |
Total Current Liabilities | |
| 46,608,192 | |
| 49,195,821 |
| | | | | | |
Deferred revenue - related party | |
| 48,279,463 | |
| 60,535,576 |
Lease obligations | |
| 17,127,159 | |
| 21,504,340 |
Asset retirement obligations | |
| 1,741,407 | |
| 1,654,755 |
Deferred income tax liability | |
| 203,255 | |
| 195,053 |
TOTAL LIABILITIES | |
| 113,959,476 | |
| 133,085,545 |
| | | | | | |
COMMITMENTS | |
|
| |
|
|
| | | | | | |
SHAREHOLDERS' EQUITY: | |
|
| |
|
|
Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 38,412,163 and 36,791,906 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | |
| 1,491 | |
| 1,429 |
Capital in excess of par value | |
| 431,103,319 | |
| 395,630,666 |
Accumulated other comprehensive loss | |
| (1,451,753) | |
| (1,794,042) |
Accumulated deficit | |
| (250,566,810) | |
| (203,035,952) |
Total Shareholders' Equity | |
| 179,086,247 | |
| 190,802,101 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | | $ | 293,045,723 | | $ | 323,887,646 |
See Notes to Condensed Consolidated Financial Statements