Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company
focused on developing gene therapies to radically transform the
lives of patients with neurodegenerative diseases, today provided
financial results for its third fiscal quarter ended December 31,
2020.
“In recent months, Sio Gene Therapies has made important
progress in advancing its patient-focused mission: harnessing the
power of gene therapy to improve the lives of patients living with
debilitating CNS diseases,” said Pavan Cheruvu, M.D., Chief
Executive Officer of Sio Gene Therapies. “Our AAV-based gene
therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff diseases
are the first gene therapy programs to enter clinical trials for
each indication, and we have just begun to see evidence of their
therapeutic potential. For the AXO-AAV-GM1 program, we presented
6-month follow up data in GM1 gangliosidosis highlighting the
potential to preserve functional outcomes, increase enzyme
activity, and reduce disease burden for patients and their
families. We expect to report 12-month clinical safety and efficacy
from the low-dose cohort, as well as biomarker data, in the second
half of 2021 while we continue to enroll patients in the high-dose
cohort. We have also made significant progress with AXO-AAV-GM2,
the first potentially disease-modifying gene therapy for GM2
gangliosidosis, which entered the clinic with dosing of the first
infantile (Type 1) patient and will continue enrollment throughout
this year.”
Dr. Cheruvu continued, “AXO-Lenti-PD represents the most
advanced gene therapy in active clinical development for
Parkinson’s disease, with a highly differentiated profile that aims
to improve motor function across a broad spectrum of disease
progression. We are working collaboratively with our partner,
Oxford Biomedica, on the development of a reliable suspension-based
manufacturing process to enable scale-up of production and
advancement of the clinical program. Oxford Biomedica has initiated
the manufacture of GMP batches using this process and we will
continue to provide periodic updates on our progress.”
“Our recent rebranding as Sio Gene Therapies, establishment of a
Board composed of a majority of independent directors, addition of
a leading AAV scientist to our advisory board, expansion of our
preclinical research and development capabilities with a new
laboratory facility in North Carolina, and extended cash runway,
leave us well-positioned to execute across our pipeline. Over the
coming year, we intend to continue advancing treatments that have
the potential to radically alter the lives of patients while we
explore opportunities to augment our existing portfolio of gene
therapies.”
Fiscal Third Quarter Financial Summary
For the third fiscal quarter ended December 31, 2020, research
and development expenses were $6.4 million, a decrease of $1.9
million compared to the prior year quarter due to a $1.0 million
nonrecurring development and regulatory milestone to UMMS achieved
in the prior year period for the AXO-AAV-GM2 program. In addition,
there were reduced AXO-Lenti-PD program costs of $1.0 million due
to lower clinical expenses as the enrollment of Cohort 2 was
completed in February 2020, as well as lower manufacturing expenses
due to delays in the development of a suspension-based
manufacturing process by our partner, Oxford Biomedica.
General and administrative expenses for the third fiscal quarter
ended December 31, 2020 were $4.2 million, a decrease of $1.2
million compared to the prior year quarter, primarily due to a
reduction in stock-based compensation expense attributable to
reduced headcount and lower grant date fair values per share for
equity awards, as well as reduced outside legal costs.
The net loss for the third fiscal quarter ended December 31,
2020 was $10.5 million, or $0.20 per share, compared to a net loss
of $14.0 million, or $0.62 per share, in the prior year
quarter.
Nine-Months Financial Summary
For the nine months ended December 31, 2020, research and
development expenses were $16.7 million, a decrease of $19.5
million compared to the nine months ended December 31, 2019. The
current period decrease was primarily related to $14.0 million in
certain nonrecurring development and regulatory milestones achieved
in the prior year period for the AXO-Lenti-PD and AXO-AAV-GM2
programs. As well, there were reduced program-specific research and
development costs of $3.7 million due to (i) lower AXO-Lenti-PD
clinical expenses as the enrollment of Cohort 2 was completed in
February 2020, as well as lower manufacturing expenses due to the
delays at Oxford and (ii) reduced clinical and manufacturing
expenses while awaiting FDA clearance of the IND for the
AXO-AAV-GM2 program.
General and administrative expenses for the nine months ended
December 31, 2020 were $13.3 million, a decrease of $3.6 million
compared to the nine months ended December 31, 2019, primarily
related to reductions in (i) personnel costs (including severance)
of $1.2 million and stock-based compensation expense of $1.0
million attributable to reduced headcount and lower grant date fair
values per share for equity awards, (ii) outside legal costs of
$0.7 million, and (iii) pharmaceutical market research expenses of
$0.6 million.
The net loss for the nine months ended December 31, 2020 was
$29.1 million, or $0.61 per share, compared to a net loss of $56.0
million, or $2.46 per share, in the nine months ended December 31,
2019. Net cash used in operating activities was $36.3 million for
the nine months ended December 31, 2020.
As of December 31, 2020, we had $81.0 million of cash and cash
equivalents. We hold no short-term or long-term debt on the balance
sheet. We expect the cash and cash equivalents to sustain our
operations into the second calendar quarter of 2022.
About Sio Gene Therapies
Sio Gene Therapies combines cutting-edge science with bold
imagination to develop genetic medicines that aim to radically
improve the lives of patients. Our current pipeline of
clinical-stage candidates includes the first potentially curative
AAV-based gene therapies for GM1 gangliosidosis and
Tay-Sachs/Sandhoff diseases, which are rare and uniformly fatal
pediatric conditions caused by single gene deficiencies. We are
also expanding the reach of gene therapy to highly prevalent
conditions such as Parkinson’s disease, which affects millions of
patients globally. Led by an experienced team of gene therapy
development experts, and supported by collaborations with premier
academic, industry and patient advocacy organizations, Sio is
focused on accelerating its candidates through clinical trials to
liberate patients with debilitating diseases through the
transformational power of gene therapies. For more information,
visit www.siogtx.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 “expect,” "estimate" and other similar
expressions are intended to identify forward-looking statements.
For example, all statements Sio makes regarding costs associated
with its operating activities are forward-looking. All
forward-looking statements are based on estimates and assumptions
by Sio’s management that, although Sio 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 Sio expected. Such risks and
uncertainties include, among others, the impact of the Covid-19
pandemic on our operations, the initiation and conduct of
preclinical studies and clinical trials; the availability of data
from clinical trials; the development of a suspension-based
manufacturing process for Axo-Lenti-PD; the scaling up of
manufacturing, the expectations for regulatory submissions and
approvals; the continued development of our gene therapy product
candidates and platforms; Sio’s scientific approach and general
development progress; and the availability or commercial potential
of Sio’s product candidates. These statements are also subject to a
number of material risks and uncertainties that are described in
Sio’s most recent Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on February 9, 2021, 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. Sio 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
Josephine Belluardo, Ph.D. LifeSci Communications(646)
751-4361jo@lifescicomms.cominfo@siogtx.com
Investors and Analysts
David NassifSio Gene Therapies, Inc.Chief Financial Officer and
General Counsel(646) 677-6770investors@siogtx.com
SIO GENE THERAPIES
INC.Condensed Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share amounts)
|
Three Months Ended December 31, |
|
Nine Months Ended December 31 |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development
expenses |
|
|
|
|
|
|
|
(includes stock-based compensation expense of $259 and $876 for the
three months ended December 31, 2020 and 2019 and $1,280 and $2,006
for the nine months ended December 31, 2020 and 2019,
respectively) |
$ |
6,407 |
|
|
|
$ |
8,267 |
|
|
|
$ |
16,659 |
|
|
|
$ |
36,190 |
|
|
General and administrative
expenses |
|
|
|
|
|
|
|
(includes stock-based compensation expense of $617 and $1,436 for
the three months ended December 31, 2020 and 2019 and $2,294 and
$3,332 for the nine months ended December 31, 2020 and 2019,
respectively) |
4,198 |
|
|
|
5,409 |
|
|
|
13,329 |
|
|
|
16,928 |
|
|
Total operating expenses |
10,605 |
|
|
|
13,676 |
|
|
|
29,988 |
|
|
|
53,118 |
|
|
Other (income) expenses: |
|
|
|
|
|
|
|
Interest expense |
1 |
|
|
|
1,066 |
|
|
|
798 |
|
|
|
3,937 |
|
|
Other (income) expense |
98 |
|
|
|
(694 |
) |
|
|
(1,388 |
) |
|
|
(1,231 |
) |
|
Loss before income tax (benefit)
expense |
(10,704 |
) |
|
|
(14,048 |
) |
|
|
(29,398 |
) |
|
|
(55,824 |
) |
|
Income tax (benefit) expense |
(188 |
) |
|
|
(9 |
) |
|
|
(304 |
) |
|
|
156 |
|
|
Net loss |
$ |
(10,516 |
) |
|
|
$ |
(14,039 |
) |
|
|
$ |
(29,094 |
) |
|
|
$ |
(55,980 |
) |
|
Net loss per common share — basic
and diluted |
$ |
(0.20 |
) |
|
|
$ |
(0.62 |
) |
|
|
$ |
(0.61 |
) |
|
|
$ |
(2.46 |
) |
|
Weighted-average common shares outstanding — basic and diluted |
52,679,816 |
|
|
|
22,791,669 |
|
|
|
47,581,795 |
|
|
|
22,785,006 |
|
|
SIO GENE THERAPIES
INC.Condensed Consolidated Balance
Sheets(Unaudited, in thousands, except share and per share
amounts)
|
December 31, 2020 |
|
March 31, 2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
81,019 |
|
|
|
$ |
80,752 |
|
|
Short-term investment |
8,055 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
6,272 |
|
|
|
2,971 |
|
|
Income tax receivable |
1,686 |
|
|
|
1,707 |
|
|
Total current assets |
97,032 |
|
|
|
85,430 |
|
|
Long-term investment |
— |
|
|
|
5,871 |
|
|
Other non-current assets |
122 |
|
|
|
46 |
|
|
Operating lease right-of-use
assets |
1,347 |
|
|
|
1,532 |
|
|
Property and equipment, net |
463 |
|
|
|
801 |
|
|
Total assets |
$ |
98,964 |
|
|
|
$ |
93,680 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
987 |
|
|
|
$ |
4,412 |
|
|
Accrued expenses |
7,722 |
|
|
|
11,319 |
|
|
Current portion of operating lease liabilities |
240 |
|
|
|
889 |
|
|
Current portion of long-term debt |
— |
|
|
|
15,423 |
|
|
Total current liabilities |
8,949 |
|
|
|
32,043 |
|
|
Operating lease liabilities, net
of current portion |
986 |
|
|
|
79 |
|
|
Total liabilities |
9,935 |
|
|
|
32,122 |
|
|
Stockholders’ equity: |
|
|
|
Common stock, par value $0.00001 per share, 1,000,000,000 shares
authorized, 56,602,626 and 39,526,299 issued and outstanding at
December 31, 2020 and March 31, 2020, respectively |
1 |
|
|
|
— |
|
|
Additional paid-in capital |
876,423 |
|
|
|
820,257 |
|
|
Accumulated deficit |
(787,738 |
) |
|
|
(758,644 |
) |
|
Accumulated other comprehensive income (loss) |
343 |
|
|
|
(55 |
) |
|
Total stockholders’ equity |
89,029 |
|
|
|
61,558 |
|
|
Total liabilities and
stockholders’ equity |
$ |
98,964 |
|
|
|
$ |
93,680 |
|
|
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