Axovant Sciences (NASDAQ:
AXON), a
clinical-stage company developing innovative gene therapies, today
provided financial results and corporate updates for its third
fiscal quarter and nine months ended December 31, 2018.
“With the addition of new investigational gene therapies for the
treatment of GM1 gangliosidosis, Tay-Sachs, and Sandhoff diseases,
we are excited about having built a deep pipeline of potentially
transformative gene therapies addressing serious conditions. Over
the last year, Axovant has become leaner and more cutting-edge in
its scientific approach, but we are no less ambitious in our drive
to make a difference for patients,” said Pavan Cheruvu, M.D., Chief
Executive Officer of Axovant. “We look forward to continuing this
momentum with a rich set of clinical development milestones this
quarter, including the first data readouts in our AXO-Lenti-PD and
AXO-AAV-GM2 programs next month, and additional milestones across
our pipeline throughout 2019.”
Key Highlights and Development
Updates
- In-licensed two programs, AXO-AAV-GM1 and AXO-AAV-GM2, for GM1
gangliosidosis, Tay-Sachs and Sandhoff diseases from the University
of Massachusetts (UMass) Medical School in December 2018. The
programs aim to restore enzymes that are deficient in these
diseases by introducing a functional copy of the defective
genes.
- First patient dosed with AXO-AAV-GM2 in an
investigator-initiated study with initial data expected in March
2019. Plan to dose first patient with AXO-AAV-GM1 in the first half
of calendar year 2019.
- Two patients were dosed with AXO-Lenti-PD in the SUNRISE-PD
trial for patients with Parkinson’s disease. Initial data is
expected in March 2019.
- FDA confirmed that studies previously conducted using first
generation ProSavin® may be considered part of a single development
program with AXO-Lenti-PD, including the preclinical data and over
10 years of clinical data of ProSavin. The FDA also provided
feedback on the design of the SUNRISE-PD phase 2 study of
AXO-Lenti-PD and agreed that current manufacturing and quality
control plans were adequate for the clinical program.
- Hired five new senior leaders with decades of collective gene
therapy expertise in key areas such as clinical development, vector
optimization and delivery, regulatory affairs, manufacturing and
commercialization. Assembled a Scientific Advisory Board of
pre-eminent leaders in gene therapy to provide strategic guidance
across all development programs.
- Shankar Ramaswamy, MD, was named Chief Business Officer and is
responsible for the identification, evaluation, and negotiation of
transactions for new gene therapy pipeline assets and other
business development opportunities. He was most recently Senior
Vice President of Business Development and Operations.
- Axovant Sciences plans to change its name to Axovant Gene
Therapies and its stock symbol to “AXGT” to reflect its exclusive
focus on the development and commercialization of innovative gene
therapies. The company’s name change is expected to take effect in
March 2019. Common stock will begin trading under a new ticker
symbol “AXGT” at the opening of trading on February 14, 2019. The
former ticker symbol “AXON” will remain effective through market
close on February 13, 2019.
- Completed $30 million equity financing in December 2018 led by
Deerfield Management Company, Sphera Funds Management and Roivant
Sciences.
Third-Quarter Financial
Summary
For the third fiscal quarter ended December 31, 2018,
research and development expenses were $21.5 million, of which
$10.0 million was attributable to the upfront licensing fee paid to
UMass Medical School and $1.9 million was attributable to non-cash,
share-based compensation expense, net of forfeitures. General and
administrative expenses for the third fiscal quarter ended December
31, 2018 were $10.9 million, of which $2.6 million was non-cash,
share-based compensation expense. Net loss for the quarter ended
December 31, 2018 was $34.3 million, or $0.27 per share.
Nine-Months Financial
Summary
For the nine months ended December 31, 2018, research and
development expenses were $80.4 million, of which $25.0 million was
attributable to the upfront licensing fee paid to Oxford BioMedica,
$10.0 million was attributable to the upfront licensing fee paid to
Benitec Biopharma, $10.0 million was attributable to the upfront
licensing fee paid to UMass Medical School and $3.3 million was
attributable to non-cash, share-based compensation expense, net of
forfeitures. General and administrative expenses for the nine
months ended December 31, 2018 were $33.3 million, of which
$9.6 million was attributable to non-cash, share-based compensation
expense. Net loss for the nine months ended December 31, 2018
was $120.0 million, or $1.01 per share.
As of December 31, 2018, the Company had $84.9 million of
cash and cash equivalents, working capital of $46.2 million, and
long-term debt of $28.3 million. Net cash used in operating
activities was $121.5 million for the nine months ended December
31, 2018, which includes the $30.0 million upfront payment to
Oxford BioMedica, $5.0 million of which was applied as a credit
against the process development work and clinical supply that
Oxford BioMedica will provide to us, the $10.0 million upfront
payment to Benitec BioPharma and the $10.0 million upfront payment
to UMass Medical School.
About Axovant Sciences
Axovant Sciences is a clinical-stage gene therapy company
focused on developing a pipeline of innovative product candidates
for debilitating neurological and neuromuscular diseases. The
company’s current pipeline of gene therapy candidates targets GM1
gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and
Sandhoff disease), Parkinson’s disease, oculopharyngeal muscular
dystrophy (OPMD), amyotrophic lateral sclerosis (ALS) and
frontotemporal dementia. Axovant is focused on accelerating product
candidates into and through clinical trials with a team of experts
in gene therapy development and through external partnerships with
leading gene therapy organizations. For more information, visit
www.axovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
The use of words such as “may,” “might,” “will,” “would,” “should,”
“expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,”
“intend,” “future,” “potential,” “continue,” or “well-positioned”
and other similar expressions are intended to identify
forward-looking statements. For example, all statements Axovant
makes regarding the initiation, timing, progress, and reporting of
results of its preclinical programs, clinical trials, and research
and development programs; its ability to advance its gene therapy
product candidates into and successfully initiate, enroll, and
complete clinical trials; the potential clinical utility of its
product candidates; its ability to continue to develop its gene
therapy platforms; its ability to develop and manufacture its
products and successfully transition manufacturing processes; its
ability to perform under existing collaborations with, among
others, Oxford BioMedica, Benitec and UMass Medical School, and to
add new programs to its pipeline; its ability to enter into new
partnerships or collaborations; its ability to retain and
successfully integrate its leadership and personnel; the timing or
likelihood of its regulatory filings and approvals, and the timing
of its expected name change and ticker symbol change are
forward-looking. All forward-looking statements are based on
estimates and assumptions by Axovant’s management that, although
Axovant believes to be reasonable, are inherently uncertain. All
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those that
Axovant expected. Such risks and uncertainties include, among
others, the initiation and conduct of preclinical studies and
clinical trials; the availability of data from clinical trials; the
expectations for regulatory submissions and approvals; the
continued development of its gene therapy product candidates and
platforms; Axovant’s scientific approach and general development
progress; and the availability or commercial potential of Axovant’s
product candidates. These statements are also subject to a number
of material risks and uncertainties that are described in Axovant’s
most recent Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on February 7, 2019, as updated by its
subsequent filings with the Securities and Exchange Commission. Any
forward-looking statement speaks only as of the date on which it
was made. Axovant undertakes no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Contacts:
Media and Investors
Tricia Truehart(631)
892-7014media@axovant.cominvestors@axovant.com
SOURCE Axovant Sciences
AXOVANT SCIENCES
LTD.Condensed Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedDecember 31, |
|
Nine Months EndedDecember 31, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development expenses(1) |
|
|
|
|
|
|
|
|
(includes total
share-based compensation expense of $1,910 and $2,453 for the three
months ended December 31, 2018 and 2017 and $3,299 and $14,625 for
the nine months ended December 31, 2018 and 2017,
respectively) |
|
$ |
21,483 |
|
|
$ |
37,346 |
|
|
$ |
80,403 |
|
|
$ |
119,613 |
|
General and
administrative expenses(2) |
|
|
|
|
|
|
|
|
(includes
share-based compensation expense of $2,648 and $8,186 for the three
months ended December 31, 2018 and 2017 and $9,575 and $26,954 for
the nine months ended December 31, 2018 and 2017,
respectively) |
|
10,933 |
|
|
18,032 |
|
|
33,309 |
|
|
69,662 |
|
Total
operating expenses |
|
32,416 |
|
|
55,378 |
|
|
113,712 |
|
|
189,275 |
|
Other expenses: |
|
|
|
|
|
|
|
|
Interest
expense |
|
1,906 |
|
|
1,950 |
|
|
5,808 |
|
|
5,702 |
|
Other
expense (income) |
|
(78 |
) |
|
550 |
|
|
275 |
|
|
324 |
|
Loss before income tax
expense |
|
(34,244 |
) |
|
(57,878 |
) |
|
(119,795 |
) |
|
(195,301 |
) |
Income tax expense |
|
52 |
|
|
24 |
|
|
224 |
|
|
953 |
|
Net loss |
|
$ |
(34,296 |
) |
|
$ |
(57,902 |
) |
|
$ |
(120,019 |
) |
|
$ |
(196,254 |
) |
Net loss per common
share — basic and diluted |
|
$ |
(0.27 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.83 |
) |
Weighted average common
shares outstanding — basic and diluted |
|
128,771,900 |
|
|
107,719,476 |
|
|
119,183,117 |
|
|
107,241,043 |
|
(1) Includes total costs allocated from Roivant Sciences Ltd.
(“RSL”), Roivant Sciences, Inc. (“RSI”) and Roivant Sciences GmbH
(“RSG”) of $0 and $409 for the three months ended December 31, 2018
and 2017, respectively, and $(450) and $5,667 for the nine months
ended December 31, 2018 and 2017, respectively.
(2) Includes total costs allocated from RSL, RSI and RSG of $698
and $1,440 for the three months ended December 31, 2018 and 2017,
respectively, and $2,772 and $4,936 for the nine months ended
December 31, 2018 and 2017, respectively.
AXOVANT SCIENCES
LTD.Condensed Consolidated Balance
Sheets(in thousands)
|
|
December 31, 2018 |
|
March 31, 2018 |
Assets |
|
(unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
84,939 |
|
|
$ |
154,337 |
|
Prepaid
expenses and other current assets |
|
4,883 |
|
|
2,174 |
|
Income
tax receivable |
|
1,580 |
|
|
1,751 |
|
Total
current assets |
|
91,402 |
|
|
158,262 |
|
Other non-current
assets |
|
3,449 |
|
|
— |
|
Property and equipment,
net |
|
1,365 |
|
|
2,524 |
|
Total
assets |
|
$ |
96,216 |
|
|
$ |
160,786 |
|
|
|
|
|
|
Liabilities and
Shareholders’ Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
1,018 |
|
|
$ |
3,949 |
|
Due to
RSL, RSI and RSG |
|
693 |
|
|
1,011 |
|
Accrued
expenses |
|
22,911 |
|
|
31,862 |
|
Current
portion of long-term debt |
|
20,583 |
|
|
9,753 |
|
Total
current liabilities |
|
45,205 |
|
|
46,575 |
|
Long-term debt |
|
28,251 |
|
|
42,925 |
|
Total
liabilities |
|
73,456 |
|
|
89,500 |
|
|
|
|
|
|
Shareholders’
equity: |
|
|
|
|
Common
shares, par value $0.00001 per share, 1,000,000,000 shares
authorized, 155,527,771 and 107,788,074 issued and outstanding at
December 31, 2018 and March 31, 2018, respectively |
|
2 |
|
|
1 |
|
Additional paid-in capital |
|
699,064 |
|
|
628,110 |
|
Accumulated deficit |
|
(676,970 |
) |
|
(556,951 |
) |
Accumulated other comprehensive income |
|
664 |
|
|
126 |
|
Total
shareholders’ equity |
|
22,760 |
|
|
71,286 |
|
Total liabilities and
shareholders’ equity |
|
$ |
96,216 |
|
|
$ |
160,786 |
|
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