MeiraGTx Reports First Quarter 2019 Financial Results and Provides
Corporate Update
MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated,
clinical stage gene therapy company, today announced financial
results for the quarter ended March 31, 2019 and provided a
corporate update.
MeiraGTx today reported positive topline data from the Company’s
Phase 1/2 trial of AAV-RPE65 for the treatment of patients with
RPE65-deficiency. Additionally, MeiraGTx has completed dosing
patients in its Phase 1/2 trial of AAV-CNGB3, an investigational
gene therapy for the treatment of achromatopsia.
During the first quarter, MeiraGTx entered into a strategic
collaboration with Janssen Pharmaceuticals, Inc. (Janssen), one of
the Janssen Pharmaceutical Companies of Johnson & Johnson, to
develop and commercialize gene therapies for the treatment of
inherited retinal diseases (IRDs). This partnership has
strengthened the Company’s balance sheet and provided collaborative
expertise from Janssen as MeiraGTx advances its broad portfolio of
gene therapy candidates.
Manufacturing to support all of MeiraGTx’s clinical programs is
currently ongoing in the Company’s wholly owned cGMP manufacturing
facility in London.
“Thanks to the commitment of the MeiraGTx team, our global
clinical partners and the patient community, we have made
considerable progress advancing our pipeline of novel gene
therapies through clinical development,” said Alexandria
Forbes, Ph.D., president and CEO. “We reached an important
milestone with results from our first clinical trial, which showed
RPE65-deficient patients gained significant improvements in vision,
and we have also completed treating patients in our CNGB3
achromatopsia study.”
Recent Clinical Development Highlights
Phase 1/2 trial of AAV-RPE65 for
RPE65-Deficiency: Today, MeiraGTx announced positive data
from the Phase 1/2 dose finding trial of AAV-RPE65, the Company’s
investigational gene therapy for the treatment of RPE65-deficiency.
A total of 15 patients were treated: nine adults in three dose
escalation cohorts and six pediatric patients in an expansion
cohort.
The trial achieved the primary endpoint of safety and
tolerability of AAV-RPE65. Additionally, AAV-RPE65 demonstrated
statistically significant improvement across several secondary
endpoints designed to assess clinical activity.
MeiraGTx expects to meet with global regulatory authorities in
the second half of 2019 to define the development pathway for
regulatory approval. The company expects to present full data from
the trial in a scientific forum later this year.
Phase 1/2 trial of AAV-CNGB3 for Achromatopsia:
Enrollment in the study is now complete. A total of 23 patients
were treated: 11 adults in dose escalation cohorts and 12 children
in a pediatric expansion cohort.
Phase 1/2 trial of AAV-RPGR for X-Linked Retinitis
Pigmentosa (XLRP): MeiraGTx is currently enrolling
patients in the U.S. and UK in the randomized extension portion of
the study.
AAV-GAD for Parkinson’s Disease: MeiraGTx
expects to meet with the FDA in mid-2019 to define the clinical
pathway to support regulatory approval of AAV-GAD in Parkinson’s
disease. The Company anticipates providing a regulatory and
clinical development update in the second half of 2019 following
interactions with regulators.
AAV-AQP1 for Grade 2/3 Radiation-Induced
Xerostomia: The Company’s single center, Phase 1 dose
finding study of AAV-AQP1 in patients with radiation-induced
xerostomia following treatment for head and neck cancer continues
to enroll with seven patients now treated in the first three
cohorts of this trial at the National Institutes of Health (NIH).
MeiraGTx expects to initiate an additional multi-center Phase 1/2
trial of AAV-AQP1 in 2019.
First Quarter 2019 Corporate Highlights
Entered into strategic collaboration with Janssen:
In January 2019, MeiraGTx entered into a strategic collaboration
and licensing agreement with Janssen to develop and commercialize
gene therapies for the treatment of IRDs.
Strengthened balance sheet: In March 2019,
MeiraGTx raised approximately $80 million of gross proceeds in a
private placement of approximately 5.8 million of its ordinary
shares. Johnson & Johnson Innovation — JJDC, Inc., the
investment arm of Johnson & Johnson, and additional
institutional investors participated in the offering.
Added General Counsel to executive management
team: In April 2019, the Company strengthened its
executive management team with the addition of Bruce Gottlieb as
General Counsel and Corporate Secretary. Mr. Gottlieb brings
significant regulatory and healthcare legal expertise to
MeiraGTx.
Appointment of new Directors: In February and
May 2019, MeiraGTx appointed Martin Indyk, Ph.D., and Nicole
Seligman, respectively, to the Company’s Board of
Directors.
First Quarter 2019 Financial ResultsAs of March
31, 2019, MeiraGTx had cash and cash equivalents of approximately
$227 million. In the first quarter of 2019, the company received
approximately $80 million of gross proceeds from a private
placement of ordinary shares to institutional investors and an
additional $100 million from a collaboration, option and license
agreement with Janssen. MeiraGTx believes this capital will be
sufficient to fund its operating expenses and capital expenditure
requirements into 2022.
Comparison of Three Months Ended March 31, 2019 and
2018
General and administrative expenses were $8.5 million for the
three months ended March 31, 2019, compared to $11.1 million for
the three months ended March 31, 2018. The decrease of $2.6 million
was primarily due to decreases in payroll and share-based
compensation, which was partially offset by increases in legal,
insurance, travel expenses, investor relations and other general
and administrative expenses.
Research and development expenses for the three months ended
March 31, 2019 were $13.0 million, compared to $7.0 million for the
three months ended March 31, 2018. The increase of $6.0 million was
primarily due to an increase in costs related to the amendment of
our license agreement with UCL Business Plc (UCLB), our
manufacturing facility, our clinical trials, consultants and legal
fees, which was partially offset by $1.3 million in research
funding provided by our collaboration and license agreements with
Janssen.
Foreign currency gain was $2.7 million for the three months
ended March 31, 2019 compared to a gain of $1.0 million for the
three months ended March 31, 2018. The increase of $1.7 million was
primarily due to a weakening of the U.S. dollar against the pound
sterling during the three months ended March 31, 2019.
Net loss for the three months ended March 31, 2019 was $18.0
million, or $(0.62) basic and diluted net loss per ordinary share,
compared to a net loss of $16.4 million, or $(1.91) basic and
diluted net loss per ordinary share for the three months ended
March 31, 2018.
MeiraGTx ended the first quarter of 2019 with $227.3 million in
cash and cash equivalents, compared to $32.4 million as of March
31, 2018.
About MeiraGTx MeiraGTx (NASDAQ:MGTX)
is a vertically integrated, clinical stage gene therapy company
with five 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 and xerophthalmia. 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 StatementThis 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 2019 milestones regarding its
pre-clinical and clinical data and reporting of such data, meetings
with regulatory authorities regarding pathways for regulatory
approval of our product candidates, timing and results of data from
the Phase 1/2 trial of AAV-RPE65 and timing of the initiation of
trials in respect to its product candidates, 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, continue
operating as a going concern, successfully execute strategic
priorities, bring product candidates to market, build-out the
manufacturing facility 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; 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; litigation risks; and the other
important factors discussed under the caption “Risk Factors” in our
Annual Report on Form 10-K for the fiscal year ended December 31,
2018 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:
MeiraGTxElizabeth Broder(646) 860-7983 Investors@meiragtx.com
or
Media: W2O pure Christiana Pascale (212)
267-6722cpascale@purecommunications.com
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash
equivalents |
$227,275,139 |
|
|
$68,080,175 |
|
|
Prepaid expenses |
1,765,209 |
|
|
1,937,785 |
|
|
Other current
assets |
2,117,334 |
|
|
4,634,105 |
|
|
|
|
|
|
|
Total Current Assets |
231,157,682 |
|
|
74,652,065 |
|
|
|
|
|
|
|
Property and
equipment, net |
15,858,667 |
|
|
22,014,237 |
|
|
Security
deposits |
107,593 |
|
|
105,085 |
|
|
Restricted cash |
123,376 |
|
|
123,376 |
|
|
Right-of-use
assets |
10,606,985 |
|
|
- |
|
|
|
|
|
|
|
|
$ |
|
$ |
|
TOTAL ASSETS |
257,854,303 |
|
|
96,894,763 |
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
CURRENT
LIABILITIES: |
|
|
|
|
Accounts payable |
$3,382,373 |
|
|
$3,042,861 |
|
|
Accrued expenses |
7,996,329 |
|
|
11,991,697 |
|
|
Lease obligations,
current |
679,025 |
|
|
27,199 |
|
|
Deferred revenue,
related party, current |
20,951,000 |
|
|
— |
|
|
Other current
liabilities |
195,618 |
|
|
437,053 |
|
|
Total Current Liabilities |
33,204,345 |
|
|
15,498,810 |
|
|
|
|
|
|
|
Deferred revenue -
related party |
77,186,561 |
|
|
— |
|
|
Lease
obligations |
2,911,331 |
|
|
7,097 |
|
|
Deferred rent |
- |
|
|
201,264 |
|
|
Asset retirement
obligations |
133,816 |
|
|
128,119 |
|
|
TOTAL LIABILITIES |
113,436,053 |
|
|
15,835,290 |
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY: |
|
|
|
|
Ordinary Shares,
$0.00003881 nominal value, 1,288,327,750 authorized
33,342,566 issued and outstanding at March 31, 2019
27,386,632 issued and outstanding at December 31, 2018 |
1,295 |
|
|
1,064 |
|
|
Capital in excess of
nominal value |
311,528,607 |
|
|
229,054,460 |
|
|
Accumulated other
comprehensive (loss) income |
(840,017 |
) |
|
293,666 |
|
|
Accumulated
deficit |
(166,271,635 |
) |
|
(148,289,717 |
) |
|
Total Shareholders' Equity |
144,418,250 |
|
|
81,059,473 |
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$257,854,303 |
|
|
$96,894,763 |
|
|
|
|
|
|
|
MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(unaudited) |
|
|
|
|
|
|
|
|
|
For the Three Month Period Ended March 31, |
|
2019 |
|
|
|
2018 |
|
|
$ |
|
|
License revenue - related
party |
$
784,960 |
|
|
$ |
- |
|
|
|
|
|
Operating expenses: |
|
|
|
General and administrative |
8,499,475 |
|
|
|
11,122,016 |
|
Research and development |
12,976,229 |
|
|
|
6,927,322 |
|
Total operating expenses |
21,475,704 |
|
|
|
18,049,338 |
|
Loss from operations |
(20,690,744 |
) |
|
|
(18,049,338 |
) |
Other non-operating income
(expense): |
|
|
|
Foreign currency gain |
2,718,400 |
|
|
|
978,624 |
|
Change in fair value of warrant liability |
- |
|
|
|
669,408 |
|
Interest income |
- |
|
|
|
25,308 |
|
Interest expense |
(9,574 |
) |
|
|
(27,355 |
) |
Net loss |
(17,981,918 |
) |
|
|
(16,403,353 |
) |
Other comprehensive (loss): |
|
|
|
Foreign currency translation |
(1,133,683 |
) |
|
|
(757,765 |
) |
Total comprehensive loss |
$(19,115,601 |
) |
|
$(17,161,118 |
) |
Net loss |
$(17,981,918 |
) |
|
$(16,403,353 |
) |
Accretion on convertible
preferred C shares and warrants |
- |
|
|
|
(664,718 |
) |
Adjusted net loss |
$(17,981,918 |
) |
|
$(17,068,071 |
) |
Basic and diluted adjusted net
loss per ordinary share |
$(0.62 |
) |
|
$(1.91 |
) |
Weighted-average number of
ordinary shares outstanding |
28,776,915 |
|
|
|
8,927,433 |
|
|
|
|
|
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