Full Press Release Details
MeiraGTx Reports First Quarter 2023 Financial and Operational Results
LONDON and NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the first quarter ended March 31, 2023, and provided a corporate update.
"We are off to a strong start this year with progress across multiple clinical-stage programs and a growing body of data supporting our proprietary gene regulation technology," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "Enrollment of the pivotal Lumeos Phase 3 study is going well and we remain on track for a BLA filing in 2024. We are also excited to be progressing towards later stage studies in our wholly-owned programs, including a randomized, double-blind, placebo-controlled, Phase 2 study for the treatment of Grade 2/3 radiation-induced xerostomia, and our randomized, sham-controlled bridging study for our Parkinson's disease program."
Dr. Forbes continued, "At this year's ARVO Annual Meeting, we presented data from our AI-driven promoter discovery platform illustrating our ability to precisely target specific cells and expression levels with synthetic promoters. In addition we presented immune-response data from the Phase 1/2 trial for the investigational gene therapy bota-vec in patients with XLRP associated with mutations in the RPGR gene. We are also pleased that nine poster presentations showcasing our novel gene and cell therapy platforms will be presented at the upcoming ASGCT Annual Meeting, including the application of our riboswitch technology to precisely regulate CAR-Ts. We are also presenting data demonstrating efficacy in animal models of vector delivered human growth hormone and anti-HER2 antibody in tight dose response to an orally dosed small molecule inducer. This provides support for the broad applicability of our riboswitch gene regulation platform for therapeutic delivery of a range of biologic drugs and cell therapies with enhanced safety and efficacy."
Recent Development Highlights and Anticipated Milestones
Bota-vec for the Treatment of XLRP:
AAV-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia:
AAV-GAD for the Treatment of Parkinson's Disease:
Riboswitch Gene Regulation Platform & Vector Engineering:
and toxicology studies, with the first GMP material for IND currently being manufactured. Two of these small molecules show good brain penetrance to enable activation of genes within the blood brain barrier.
Recent Corporate Developments
In May 2023, MeiraGTx closed the previously announced private investment in public equity (PIPE) financing, raising approximately $60 million in aggregate gross proceeds. The financing was entirely led by several of the Company's top holders Perceptive Advisors, Adage Capital, Prosight Management, and 683 Capital Management.
For more information related to our clinical trials, please visit www.clinicaltrials.gov
In addition to the proceeds from the PIPE financing, MeiraGTx had cash and cash equivalents of approximately $68.8 million, as well as approximately $36.3 million in receivables due from Janssen. The Company believes that with such funds, as well as anticipated milestones from Janssen, it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second quarter of 2025.
Cash and cash equivalents were $68.8 million as of March 31, 2023, compared to $115.5 million as of December 31, 2022.
License revenue was $3.3 million for the quarter ended March 31, 2023, compared to $5.6 million for the quarter ended March 31, 2022. This decrease represents decreased amortization of the $100.0 million upfront payment as well as decreased amortization of the $30.0 million milestone payment received in connection with the Janssen collaboration.
General and administrative expenses were $12.8 million for the three months ended March 31, 2023, compared to $11.3 million for the three months ended March 31, 2022. The increase of $1.5 million was primarily due to an increase in legal and accounting fees, consulting fees and other office related costs. These increases were partially offset by decreases in share-based compensation, insurance costs and payroll and payroll-related costs.
Research and development expenses for the three months ended March 31, 2023 were $22.3 million, compared to $23.1 million for the three months ended March 31, 2022. The decrease of $0.8 million was primarily due to a decrease in expenses related to our preclinical programs primarily due to the timing of expenses in our gene regulation program and a decrease in other research and development expenses primarily due to a decrease in share-based compensation, as well as an increase in research funding provided under our Janssen collaboration primarily due to the increase in expenses incurred related to our program for bota-vec for the treatment of XLRP. These decreases were partially offset by an increase in clinical trial expenses primarily due to an increase in expenses related to our Phase 3 Lumeos clinical trial of bota-vec and our expanded Phase 1 clinical trial and Phase 2 clinical trial for AAV-hAQP1, as well as an increase in
manufacturing expenses primarily due to the commencement of operations at our Shannon, Ireland manufacturing facility in 2022.
Foreign currency gain was $3.9 million for the three months ended March 31, 2023, compared to a loss of $2.6 million for the three months ended March 31, 2022. The change of $6.5 million was primarily due to an unrealized gain on the quarterly valuation of intercompany payables and receivables due to the weakening of the U.S. dollar against the pound sterling and euro during the three months ended March 31, 2023.
Net loss attributable to ordinary shareholders for the quarter ended March 31, 2023 was $30.4 million, or $0.62 basic and diluted net loss per ordinary share, compared to a net loss attributable to ordinary shareholders of $31.0 million, or $0.70 basic and diluted net loss per ordinary share for the quarter ended March 31, 2022.
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, and a transformative gene regulation platform technology that allows precise, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. 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 diseases, including both inherited retinal diseases as well as large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus 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, reporting of such data and the timing of results of data and regulatory matters, 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, repay our debt obligations, 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 March 31, 2023, 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.
LifeSci Communications
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 Period Ended March 31, | ||||||
| 2023 | 2022 | |||||
| License revenue - related party | $ | 3,334 | $ | 5,633 | ||
| Operating expenses: | ||||||
| General and administrative | 12,772 | 11,268 | ||||
| Research and development | 22,322 | 23,099 | ||||
| Total operating expenses | 35,094 | 34,367 | ||||
| Loss from operations | (31,760) | (28,734) | ||||
| Other non-operating income (expense): | ||||||
| Foreign currency gain (loss) | 3,857 | (2,647) | ||||
| Interest income | 545 | 16 | ||||
| Interest expense | (3,060) | (77) | ||||
| Fair value adjustment | 54 | 397 | ||||
| Net loss | (30,364) | (31,045) | ||||
| Other comprehensive (loss) income: | ||||||
| Foreign currency translation (loss) gain | (2,353) | 1,932 | ||||
| Comprehensive loss | $ | (32,717) | $ | (29,113) | ||
| Net loss | $ | (30,364) | $ | (31,045) | ||
| Basic and diluted net loss per ordinary share | $ | (0.62) | $ | (0.70) | ||
| Weighted-average number of ordinary shares outstanding | 48,638,151 | 44,501,314 |
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
| March 31, | December 31, | |||||
| 2023 | 2022 | |||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 68,784 | $ | 115,516 | ||
| Accounts receivable - related party | 36,298 | 21,334 | ||||
| Prepaid expenses | 6,981 | 8,133 | ||||
| Tax incentive receivable | 7,857 | 7,689 | ||||
| Other current assets | 1,561 | 1,667 | ||||
| Total Current Assets | 121,481 | 154,339 | ||||
| Property, plant and equipment, net | 112,580 | 109,266 | ||||
| Intangible assets, net | 1,295 | 1,335 | ||||
| In-process research and development | 752 | 742 | ||||
| Other assets | 1,428 | 1,402 | ||||
| Equity method and other investments | 6,326 | 6,326 | ||||
| Right-of-use assets - operating leases, net | 19,427 | 20,109 | ||||
| Right-of-use assets - finance leases, net | 24,851 | 24,718 | ||||
| TOTAL ASSETS | $ | 288,140 | $ | 318,237 | ||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
| CURRENT LIABILITIES: | ||||||
| Accounts payable | $ | 29,755 | $ | 16,616 | ||
| Accrued expenses | 31,067 | 39,818 | ||||
| Lease obligations, current | 4,018 | 3,884 | ||||
| Deferred revenue - related party, current | 13,693 | 15,123 | ||||
| Other current liabilities | 2,571 | 6,631 | ||||
| Total Current Liabilities | 81,104 | 82,072 | ||||
| Deferred revenue - related party | 26,425 | 27,436 | ||||
| Lease obligations | 16,453 | 17,331 | ||||
| Asset retirement obligations | 2,238 | 2,179 | ||||
| Deferred income tax liability | 189 | 186 | ||||
| Note payable, net | 71,301 | 71,033 | ||||
| Other long-term liabilities | 208 | 262 | ||||
| TOTAL LIABILITIES | 197,918 | 200,499 | ||||
| COMMITMENTS AND CONTINGENCIES (Note 10) | ||||||
| SHAREHOLDERS' EQUITY: | ||||||
| Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 48,686,263 and 48,477,209 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 2 | 2 | ||||
| Capital in excess of par value | 587,094 | 581,893 | ||||
| Accumulated other comprehensive income | 3,694 | 6,047 | ||||
| Accumulated deficit | (500,568) | (470,204) | ||||
| Total Shareholders' Equity | 90,222 | 117,738 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 288,140 | $ | 318,237 |