MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated,
clinical stage gene therapy company, today announced financial
results for the third quarter of 2018 and provided a corporate
update.
“The third quarter was very productive for MeiraGTx, marked by
clinical progress across our pipeline, several corporate
announcements and important regulatory designations,” said
Alexandria Forbes, Ph.D., president and chief executive officer of
MeiraGTx. “In the past month, we entered into an exclusive
licensing agreement with the NIH for a gene therapy treatment for
Sjögren’s syndrome, announced a collaboration agreement with
Janssen Pharmaceuticals focused on our proprietary riboswitch
technology and acquired a novel Phase 2 Parkinson’s gene therapy
product candidate. The hard work of our employees and partners
continues to have meaningful impact, both for MeiraGTx and for
patients suffering from the devastating, debilitating diseases that
we are seeking to address.”
Corporate Highlights
NIH exclusive license: On September 7, 2018,
MeiraGTx entered into an exclusive licensing agreement with the
National Institute of Dental and Craniofacial Research, a division
of the National Institutes of Health (NIH), for gene therapy
treatment for Sjögren’s syndrome and associated xerostomia (dry
mouth) or xerophthalmia (dry eye). Under the
agreement, MeiraGTx will receive worldwide rights to
adeno-associated virus vector mediated gene delivery of
aquaporin-1, designated AAV-AQP1, for Sjögren’s syndrome patients
with associated xerostomia (dry mouth) or xerophthalmia (dry
eye).
Phase 2 Parkinson’s Disease program: On October
5, 2018, MeiraGTx acquired Vector Neurosciences Inc. in an
all-stock transaction. As a result of the acquisition,
MeiraGTx expanded its portfolio of clinical stage product
candidates to include adeno-associated virus encoding glutamic acid
decarboxylase (AAV-GAD). A prior Phase 2 clinical trial of AAV-GAD
was completed and was the first successful randomized,
double-blind, sham-controlled trial of its kind for a gene therapy
product candidate targeting a brain disorder.
Janssen Pharmaceuticals collaboration
agreement: On October 9, 2018, MeiraGTx entered into a
research collaboration and evaluation agreement with Janssen
Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies
of Johnson & Johnson. As part of the
agreement, MeiraGTx will use its proprietary riboswitch
technology to engineer regulatable gene therapy constructs encoding
proprietary gene sequences from Janssen. Evaluation of the
performance of these constructs will determine the utility of this
approach in future product development.
Clinical Development Highlights
AAV-CNGB3: Treated two additional pediatric
patients in the extension phase of the Phase 1/2 study, bringing
the total number of patients treated to 16 (11 adults and five
pediatrics). The Company anticipates completing dosing the
pediatric extension phase in 2018.
AAV-RPGR: Completed dose escalation phase of
the Phase 1/2 study, bringing the total number treated to 10
patients. The Company expects to initiate dosing in the pediatric
extension phase of the study in 2018.
AAV-RPE65: Dosing in the Phase 1/2 clinical
study was completed in the second quarter of 2018. A total of nine
adults were treated in three escalating dose cohorts. Six pediatric
patients were treated in the pediatric extension arm of the
study.
AAV-CNGA3: cGMP manufacturing of clinical
material is ongoing in our manufacturing facility. We anticipate
release in the next few months with the initiation of the treatment
study in early 2019.
Regulatory Highlights
FDA Rare Pediatric Disease Designation for Achromatopsia
Treatment (AAV-CNGA3): On August 21, 2018, the Offices
of Orphan Products Development and Pediatric Therapeutics
of the U.S. Food and Drug Administration (“FDA”) granted
rare pediatric disease designation for the Company’s gene therapy
product candidate AAV-CNGA3 for the treatment of patients with
achromatopsia (ACHM) caused by mutations in
the CNGA3 gene.
FDA Fast Track Designation for Achromatopsia Treatment
(AAV-CNGB3): On August 16, 2018, the FDA granted Fast
Track designation for the Company’s AAV-CNGB3 gene therapy product
candidate for the treatment of achromatopsia (ACHM) caused by
mutations in the CNGB3 gene.
FDA Orphan Drug Designation for Achromatopsia Treatment
(AAV-CNGA3): On August 7, 2018, the FDA granted
orphan drug designation (ODD) for the Company’s AAV-CNGA3 gene
therapy product candidate for the treatment of achromatopsia (ACHM)
caused by mutations in the CNGA3 gene.
Third Quarter 2018 Financial Results
Comparison of Three Months Ended September 30, 2018 and 2017
General and administrative expenses were $6.6 million for
the three months ended September 30, 2018, compared to
$2.4 million for the three months ended September 30,
2017. The increase of $4.2 million was primarily due to
increases of $1.7 million in payroll, $1.8 million in
share-based compensation, $0.7 million in legal and accounting
fees, $0.2 million in investor relations costs and
$0.3 million in insurance costs, which was partially offset by
decreases of $0.4 million in rent and $0.1 million in
depreciation expenses.
Research and development expenses for the three months ended
September 30, 2018 were $8.1 million, compared to
$6.4 million for the three months ended September 30,
2017. The increase of $1.7 million was primarily due to an
increase in costs of $2.1 million related to preparation of
our manufacturing facility for production, $0.6 million in
share-based compensation expense and $0.2 million in legal
fees, which was partially offset by a decrease of $1.2 million
in clinical trial material costs.
Foreign currency loss was $0.7 million for the three months
ended September 30, 2018 compared to a gain of
$0.4 million for the three months ended September 30,
2017. The increase of $1.1 million was primarily due to a
strengthening U.S. dollar against the pound sterling during the
three-months ended September 30, 2018.
Net loss for the three months ended September 30, 2018 was $15.4
million, or $(0.59) basic and diluted net loss per ordinary share,
compared to a net loss of $8.4 million, or $(1.00) basic and
diluted net loss per ordinary share for the three months ended
September 30, 2017.
MeiraGTx ended the third quarter of 2018 with $88.6 million in
cash and cash equivalents, compared to $8.5 million as of December
31, 2017.
About MeiraGTx MeiraGTx (NASDAQ:MGTX)
is a vertically integrated, clinical stage gene therapy company
with four ongoing clinical programs 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, severe forms of xerostomia and neurodegenerative
diseases. Though initially focusing on the eye, salivary gland and
central nervous system, 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 StatementsThis 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 product
pipeline, anticipated product benefits, goals and strategic
priorities, product candidate development, growth expectations or
targets and pre-clinical and clinical 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, 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
final prospectus under Rule 424(b) filed with the U.S. Securities
and Exchange Commission (“SEC”) in connection with our initial
public offering 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
Investors@meiragtx.com
Media: W2O GroupChristiana Pascale (212) 267-6722
cpascale@w2ogroup.com
MEIRAGTX HOLDINGS PLC AND
SUBSIDIARIES |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
Cash |
|
$ |
88,560,634 |
|
|
$ |
8,548,638 |
|
|
Prepaid
expenses |
|
|
2,029,327 |
|
|
|
1,961,243 |
|
|
Other
current assets |
|
|
716,737 |
|
|
|
965,233 |
|
|
Total
Current Assets |
|
|
91,306,698 |
|
|
|
11,475,114 |
|
|
Property
and equipment, net |
|
|
13,624,968 |
|
|
|
14,255,729 |
|
|
Security
deposits |
|
|
180,870 |
|
|
|
- |
|
|
Restricted cash |
|
|
123,376 |
|
|
|
123,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
105,235,912 |
|
|
$ |
25,854,219 |
|
|
|
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND
SHAREHOLDERS' EQUITY (DEFICIT) |
|
CURRENT
LIABILITIES: |
|
|
|
|
|
Accounts
payable |
|
$ |
2,415,667 |
|
|
$ |
7,055,380 |
|
|
Accrued
expenses |
|
|
6,042,290 |
|
|
|
9,332,944 |
|
|
Note
payable |
|
|
— |
|
|
|
1,442,009 |
|
|
Warrant
liability |
|
|
— |
|
|
|
2,679,633 |
|
|
Capitalized lease obligation - current portion |
|
|
29,284 |
|
|
|
30,850 |
|
|
Due to
Kadmon |
|
|
— |
|
|
|
861,030 |
|
|
Total
Current Liabilities |
|
|
8,487,241 |
|
|
|
21,401,846 |
|
|
Capitalized lease obligation |
|
|
12,092 |
|
|
|
34,298 |
|
|
Deferred
rent |
|
|
210,993 |
|
|
|
266,290 |
|
|
Asset
retirement obligation |
|
|
181,515 |
|
|
|
178,419 |
|
|
TOTAL
LIABILITIES |
|
|
8,891,841 |
|
|
|
21,880,853 |
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
|
|
CONVERTIBLE PREFERRED C SHARES |
|
|
|
|
|
|
|
|
|
|
|
Convertible Preferred C Shares 0 and 5,005,935 outstanding
at September 30, 2018 and December 31, 2017, respectively
(liquidation preference of $52,455,700 at December 31, 2017) |
|
|
— |
|
|
|
51,338,631 |
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY (DEFICIT): |
|
|
|
|
|
Ordinary
Shares, $0.00003881 nominal value, 1,288,327,750 authorized
27,184,132 issued and outstanding at September 30, 2018
8,826,190 issued and 8,714,563 issued and outstanding at December
31, 2017 |
|
|
1,055 |
|
|
|
342 |
|
|
Capital
in excess of nominal value |
|
|
223,868,465 |
|
|
|
20,080,713 |
|
|
Accumulated other comprehensive loss |
|
|
(292,477 |
) |
|
|
(2,022,477 |
) |
|
Accumulated deficit |
|
|
(127,232,972 |
) |
|
|
(65,423,843 |
) |
|
Total
Shareholders' Equity (Deficit) |
|
|
96,344,071 |
|
|
|
(47,365,265 |
) |
|
TOTAL
LIABILITIES, CONVERTIBLE PREFERRED C SHARES AND SHAREHOLDERS'
EQUITY (DEFICIT) |
|
$ |
105,235,912 |
|
|
$ |
25,854,219 |
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial
Statements |
|
|
|
|
|
|
|
MEIRAGTX HOLDINGS PLC AND
SUBSIDIARIES |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three-Month Period Ended
September 30, |
|
For the Nine-Month Period Ended September 30, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
General
and administrative |
|
$ |
6,629,052 |
|
|
$ |
2,374,527 |
|
|
$ |
35,129,120 |
|
|
$ |
6,744,963 |
|
|
Research
and development |
|
|
8,109,160 |
|
|
|
6,388,227 |
|
|
|
22,827,176 |
|
|
|
16,575,129 |
|
|
Total
operating expenses |
|
|
14,738,212 |
|
|
|
8,762,754 |
|
|
|
57,956,296 |
|
|
|
23,320,092 |
|
|
Loss
from operations |
|
|
(14,738,212 |
) |
|
|
(8,762,754 |
) |
|
|
(57,956,296 |
) |
|
|
(23,320,092 |
) |
|
Other
non-operating income (expense): |
|
|
|
|
|
|
|
|
|
Other
income |
|
|
- |
|
|
|
— |
|
|
|
83,075 |
|
|
|
— |
|
|
Foreign
currency (loss) gain |
|
|
(677,488 |
) |
|
|
391,521 |
|
|
|
(2,425,488 |
) |
|
|
990,395 |
|
|
Change in
fair value of warrant liability |
|
|
- |
|
|
|
— |
|
|
|
(1,514,775 |
) |
|
|
— |
|
|
Interest
income |
|
|
264 |
|
|
|
2,915 |
|
|
|
50,926 |
|
|
|
21,295 |
|
|
Interest
expense |
|
|
(9,508 |
) |
|
|
(72,736 |
) |
|
|
(46,571 |
) |
|
|
(131,756 |
) |
|
Net
loss |
|
|
(15,424,944 |
) |
|
|
(8,441,054 |
) |
|
|
(61,809,129 |
) |
|
|
(22,440,158 |
) |
|
Comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
Foreign
currency translation |
|
|
508,758 |
|
|
|
(348,338 |
) |
|
|
1,730,000 |
|
|
|
(824,252 |
) |
|
Total
comprehensive loss |
|
$ |
(14,916,186 |
) |
|
$ |
(8,789,392 |
) |
|
$ |
(60,079,129 |
) |
|
$ |
(23,264,410 |
) |
|
Net
loss |
|
$ |
(15,424,944 |
) |
|
$ |
(8,441,054 |
) |
|
$ |
(61,809,129 |
) |
|
$ |
(22,440,158 |
) |
|
Accretion on convertible preferred C shares and warrants |
|
|
- |
|
|
|
(191,758 |
) |
|
|
(1,806,512 |
) |
|
|
(244,920 |
) |
|
Adjusted
net loss |
|
$ |
(15,424,944 |
) |
|
$ |
(8,632,812 |
) |
|
$ |
(63,615,641 |
) |
|
$ |
(22,685,078 |
) |
|
Basic
and diluted net loss per ordinary share |
|
$ |
(0.59 |
) |
|
$ |
(1.00 |
) |
|
$ |
(3.89 |
) |
|
$ |
(2.66 |
) |
|
Weighted-average number of ordinary shares outstanding |
|
|
26,340,450 |
|
|
|
8,607,832 |
|
|
|
16,355,849 |
|
|
|
8,536,447 |
|
|
|
|
|
|
|
|
|
|
|
|
See Notes to Condensed Consolidated Financial
Statements |
|
|
|
|
|
|
|
|
|
|
|
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