Axovant Sciences (NASDAQ:AXON) today announced corporate updates
and financial results for its first fiscal quarter ended June 30,
2018.
“Axovant is methodically rebuilding its clinical
pipeline with the goal of becoming a leader in neurological gene
therapies. We are focused on transformative approaches that can
have a significant impact on the lives of patients suffering from
debilitating or potentially life-threatening conditions. With the
promotion of Ilise Lombardo, MD, to Chief Medical Officer, and the
addition of several key members to our leadership team, we are
well-positioned to initiate two potentially pivotal clinical
studies with AXO-Lenti-PD and AXO-AAV-OPMD,” said Pavan Cheruvu,
MD, Chief Executive Officer of Axovant.
“We also continue to identify opportunities to
further strengthen our pipeline, focusing on programs that will be
in the clinic in the next 12 to 18 months and that have
genetically-identifiable targets in indications with
well-characterized biology. I look forward to providing additional
updates as these efforts progress.”
Key Highlights since March 31,
2018
- Announced global licensing agreement for AXO-Lenti-PD, an
investigational gene therapy for Parkinson’s disease, from Oxford
BioMedica. Axovant expects to initiate a Phase 1/2 dose escalation
study of AXO-Lenti-PD in patients with advanced Parkinson’s disease
by the end of 2018, with initial clinical data from the study
available in 2019.
- Announced global licensing agreement with Benitec Biopharma for
AXO-AAV-OPMD, a potential one-time treatment for oculopharyngeal
muscular dystrophy, and a broader platform collaboration for
development of five additional gene therapy products in
neurological disorders. Axovant plans to initiate a
placebo-controlled clinical study of AXO-AAV-OPMD in 2019.
- Received $25.0 million net proceeds from private placement of
common stock to Roivant Sciences Ltd.
- Additional leadership hires included Dr. Gavin Corcoran as
Executive Vice President of Research & Development and Dr.
Fraser Wright as Chief Technology Officer overseeing the Company’s
gene therapy initiatives.
- Announced the formation of Scientific Advisory Board to be led
by Dr. Michael Hayden, who was also named as a senior scientific
advisor to the Company.
Promotion of Ilise Lombardo, MD to Chief
Medical Officer
Today, Axovant announced the promotion of Ilise
Lombardo, MD, to Chief Medical Officer. Dr. Lombardo joined Axovant
in April 2015 and most recently served as Senior Vice President,
Clinical Research. She has over 16 years of experience in the
pharmaceutical industry, leading clinical development and medical
affairs programs across multiple therapeutic areas, including CNS
disorders and rare diseases. Previously, she was Vice
President, Clinical Development and Medical Affairs, at FORUM
Pharmaceuticals. Prior to that, she held multiple roles of
increasing responsibility at Pfizer, including Medicines
Development Lead for VYNDAQEL™ (tafamidis) and Specialty Care Group
Leader for US Medical Affairs where she oversaw five therapeutic
areas. Dr. Lombardo is a trained psychiatrist who previously served
on the faculty of Columbia University College of Physicians and
Surgeons and the New York State Psychiatric Institute. She
completed her internship and residency in psychiatry and a
post-doctoral fellowship in molecular neuroimaging at Columbia
University College of Physicians and Surgeons as well as a research
fellowship in molecular biology at Yale University and the
University of Cambridge. She received her M.D. from Yale
University, an M.Phil. from the University of Cambridge, and an
A.B. from Brown University.
“I am excited about our new gene therapy
pipeline that will leverage our expertise in the clinical
development of treatments for debilitating neurological diseases,”
commented Dr. Lombardo. “We have the opportunity to drive the
growth of the Company based on transformative science, and I am
honored to take on the role of CMO at this time.”
Development Update
Top-line data from the Phase 2 study evaluating
nelotanserin for treatment of REM Sleep Behavior Disorder in
subjects with Lewy body dementia are expected in the second half of
2018. We plan to determine the overall development strategy for
nelotanserin once we have reviewed the final data from this study
and have completed our ongoing comprehensive clinical, regulatory
and commercial review.
Financial Summary
For the first fiscal quarter ended June 30,
2018, research and development expenses were $37.4 million, of
which $25.0 million was attributable to the upfront licensing fee
paid to Oxford BioMedica and $2.5 million was attributable to
non-cash, share-based compensation expense. General and
administrative expenses for the first fiscal quarter ended June 30,
2018 were $11.8 million, of which $3.3 million was attributable to
non-cash, share-based compensation expense. Net loss for the
quarter ended June 30, 2018 was $51.9 million, or $0.48 per
share.
As of June 30, 2018, the Company had $92.9
million of cash, working capital of $58.5 million and long-term
debt of $38.2 million. Adjusting for the net proceeds of $25.0
million from the private placement of common shares to Roivant
Sciences Ltd. and the $10.0 million upfront licensing fee paid to
Benitec Biopharma, both of which occurred in early July 2018, the
Company would have had as adjusted cash of $107.9 million and
working capital of $73.5 million as of June 30, 2018.
Net cash used in operating activities was $61.4
million for the three months ended June 30, 2018, which includes
the $30.0 million upfront payment to Oxford BioMedica, $5.0 million
of which will be applied as a credit against the process
development work and clinical supply that Oxford BioMedica will
provide to us.
About Axovant Sciences
Axovant is a clinical-stage biopharmaceutical
company focused on the acquisition, development and
commercialization of novel therapeutics in the fields of neurology
and psychiatry. We are developing a pipeline of clinical and
nonclinical product candidates that focuses on the various aspects
of debilitating neurodegenerative diseases such as Parkinson's
disease, oculopharyngeal muscular dystrophy, Lewy body dementia and
other indications in the fields of neurology and psychiatry. Our
goal is to be the leading biopharmaceutical company focused on the
fields of neurology and psychiatry.
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,” “goal,” “anticipate,”
“believe,” “estimate,” “undoubtedly,” “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 and clinical trials and its research and
development programs, its ability to advance its small molecule and
gene therapies into, and successfully initiate, enroll and
complete, clinical trials, the potential clinical utility of its
product candidates, its ability to continue to develop its small
molecule and 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 and Benitec, 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 including its
Scientific Advisory Board, and the timing or likelihood of its
regulatory filings and approvals, 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, conduct and success 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 small molecule and gene therapy
products 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission, 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, except as required by
law.
|
AXOVANT SCIENCES LTD.Condensed
Consolidated Statements of Operations(Unaudited, in
thousands, except share and per share amounts) |
|
|
|
|
|
Three Months Ended June 30, 2018 |
|
Three Months Ended June 30, 2017 |
Operating
expenses: |
|
|
|
Research and
development expenses(1) |
|
|
|
(includes
share-based compensation expense of $2,517 and $6,256 for the three
months ended June 30, 2018 and 2017, respectively) |
$ |
37,418 |
|
|
$ |
43,712 |
|
General and
administrative expenses(2) |
|
|
|
(includes
share-based compensation expense of $3,342 and $9,344 for the three
months ended June 30, 2018 and 2017, respectively) |
11,754 |
|
|
21,518 |
|
Total
operating expenses |
49,172 |
|
|
65,230 |
|
|
|
|
|
Interest
expense |
1,970 |
|
|
1,874 |
|
Other
expense (income) |
668 |
|
|
(357 |
) |
|
|
|
|
Loss before income tax
expense |
(51,810 |
) |
|
(66,747 |
) |
|
|
|
|
Income tax expense |
78 |
|
|
2,519 |
|
|
|
|
|
Net loss |
$ |
(51,888 |
) |
|
$ |
(69,266 |
) |
|
|
|
|
Net loss per common
share — basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
Weighted average common
shares outstanding — basic and diluted |
107,789,920 |
|
|
106,400,912 |
|
|
|
|
|
|
|
(1) Includes $2,619 and $3,001 of total costs allocated from
Roivant Sciences Ltd. (“RSL”), Roivant Sciences, Inc. (“RSI”) and
Roivant Sciences GmbH (“RSG”) for the three months ended June 30,
2018 and June 30, 2017, respectively.
(2) Includes $1,302 and $1,873 of total costs allocated from
RSL, RSI and RSG for the three months ended June 30, 2018 and June
30, 2017, respectively.
AXOVANT SCIENCES LTD.Condensed
Consolidated Balance Sheets(Unaudited, in thousands) |
|
|
June 30, 2018 |
|
March 31, 2018 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
92,934 |
|
|
$ |
154,337 |
|
Prepaid
expenses and other current assets |
7,448 |
|
|
2,174 |
|
Income
tax receivable |
1,616 |
|
|
1,751 |
|
Total
current assets |
101,998 |
|
|
158,262 |
|
Other non-current
assets |
3,784 |
|
|
— |
|
Property and equipment,
net |
1,802 |
|
|
2,524 |
|
Total
assets |
$ |
107,584 |
|
|
$ |
160,786 |
|
|
|
|
|
Liabilities and
Shareholders’ Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1,431 |
|
|
$ |
3,949 |
|
Due to
RSL, RSI and RSG |
2,156 |
|
|
1,011 |
|
Accrued
expenses |
25,133 |
|
|
31,862 |
|
Current
portion of long term debt |
14,791 |
|
|
9,753 |
|
Total
current liabilities |
43,511 |
|
|
46,575 |
|
|
|
|
|
Long term debt |
38,247 |
|
|
42,925 |
|
|
|
|
|
Total
liabilities |
81,758 |
|
|
89,500 |
|
Total
shareholders’ equity |
25,826 |
|
|
71,286 |
|
Total liabilities and
shareholders’ equity |
$ |
107,584 |
|
|
$ |
160,786 |
|
|
|
|
|
|
|
|
|
Contact:
InvestorsTricia Truehart(631)
892-7014investors@axovant.com
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