Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
biotechnology company conducting human clinical trials of
adeno-associated virus (AAV)-based gene therapies for the treatment
of rare diseases, today announced financial results for the quarter
ended December 31, 2020.
“We believe that the data generated to date in
our XLRP trials continue to give us a leading position in this
indication and we are eager to move our Phase 1/2 expansion
(Skyline) and Phase 2/3 (Vista) trials forward,” said Sue Washer,
President and CEO of AGTC. “The latest data from our ongoing Phase
1/2 trials in patients with achromatopsia provide the first
reported quantitative evidence of improvements in visual
sensitivity and provide a path forward to collect additional data
and to fully realize the potential of this treatment.
Continued progress in our clinical and earlier-stage development
efforts is expected to create multiple data milestones, including
four important data releases for XLRP and two for achromatopsia
over the next two years, while bringing us closer to our goal of
developing best-in-class therapies that provide meaningful benefit
to patients.”
X-linked Retinitis Pigmentosa
(XLRP)In November 2020, the Company reported additional
positive data from its Phase 1/2 clinical trial in patients with
XLRP that indicated durable improvements observed in visual
sensitivity and supportive trends in visual acuity over a wide dose
range with a favorable safety profile out to month 12 in two of the
dose groups. The Company believes it has a best-in-class product
candidate that may provide significant benefit to patients with
XLRP. The Company expects to:
- Provide 12-month data for Phase 1/2
dose groups 5 and 6 in 2Q 2021;
- Provide Skyline trial results from
the 3-month masked interim analysis in 4Q 2021;
- Provide Skyline trial results from
the 12-month data in 3Q 2022; and
- Provide Vista trial results from
the 6-month masked interim analysis in 3Q 2022.
Achromatopsia (ACHM)In January
2021, the Company announced the first reported quantitative
evidence of improvement in visual sensitivity, as measured by full
field static perimetry, supported in some patients by other
endpoints. Seven of the 16 patients in the three highest dose
groups in the ACHMB3 trial showed these improvements in visual
sensitivity in the treated area. No consistent results were seen in
the other dose groups. In a subset of these patients with evaluable
multi-focal electroretinograms (mfERG), improvements in electrical
signaling were measurable in the same treated area.
For ACHMA3, of the 16 patients in the four
highest dose groups, three patients showed improvements in visual
sensitivity in the treated area, as measured by static perimetry.
No consistent results were seen in other dose groups. None of these
three patients with improvements in visual sensitivity had
evaluable mfERGs.
AGTC currently plans to focus on completing
enrollment of pediatric patients in the two highest dose groups in
its ACHMB3 and ACHMA3 trials and to follow all patients through 12
months. The Company expects to:
- Provide 12-month data from the
adult patients in both trials in 2Q 2021; and
- Provide preliminary 3-month data
from the pediatric patients in both trials in 4Q 2021, AGTC
currently plans to focus on completing enrollment depending on any
effects of the COVID pandemic.
Financial Results for the Three and Six Months Ended
December 31, 2020
Revenue: There was no
revenue for the three and six months ended December 31, 2020, as
compared to $2.5 million in each of the comparable 2019
periods. Revenue during the three and six months ended December 31,
2019 was primarily due to $2.2 million
of non-cash collaboration revenue in connection
with in-kind contributions made to Bionic Sight, LLC
pursuant to a collaborative agreement.
R&D Expenses: Research and
development expenses for the three and six months ended December
31, 2020 were $11.8 million and $23.4 million, respectively,
compared to $8.4 million and $17.0 million, respectively,
during the comparable 2019 periods. The increase of
$6.4 million during the 2020 six-month period was primarily
due to increased external XLRP spending for planned manufacturing,
clinical site preparation and other activities related to the
Skyline and Vista trials, partially offset by decreased external
ACHM spending.
G&A Expenses:
General and administrative expenses for the three and six months
ended December 31, 2020 were $3.3 million and $6.7 million,
respectively, compared to $3.0 million and $6.4 million,
respectively, during the comparable 2019 periods. The increase of
$0.3 million during the 2020 six-month period was primarily due to
higher fees from outside legal counsel, partially offset by lower
employee-related expenses and share-based compensation expense.
Investment Income, net:
Investment income, net for the three and six months ended December
31, 2020 declined by $0.3 million and $0.7 million, respectively,
when compared to the comparable 2019 periods, which was primarily
due to lower interest rates in the marketplace.
Interest Expense: Interest
expense for the three and six months ended December 31, 2020
increased by $0.3 million and $0.7 million, respectively, when
compared to the comparable 2019 periods due to the loan agreement
that the Company entered into on June 30, 2020.
Net Loss: The Company’s net
loss for the three and six months ended December 31, 2020 was $15.5
million and $30.8 million, respectively, compared to
$8.6 million and $20.2 million, respectively, during the
comparable 2019 periods.
Financial Guidance: As of
December 31, 2020, the Company’s cash, cash equivalents and
investments totaled $53.1 million. The Company believes that
these funds, along with net proceeds of approximately $69.2 million
from an underwritten public offering that closed in February 2021,
will be sufficient to allow the Company to generate data from its
ongoing and planned clinical programs and fund currently planned
research and discovery programs into calendar year 2023.
Conference Call and WebcastAGTC
will host a conference call and webcast to discuss financial
results for the fiscal quarter ended December 31,
2020 today at 8:00 a.m. ET. To access the call, dial
877-407-6184 (US) or 201-389-0877 (outside of the US). A live
webcast will be available in the Events and Presentations section
of AGTC’s Investor Relations site
at http://ir.agtc.com/events-and-presentations. Please log in
approximately 10 minutes prior to the scheduled start time.
The archived webcast will be available in the
Events and Presentations section of the Company's website.
About AGTCAGTC is a
clinical-stage biotechnology company developing genetic therapies
for people with rare and debilitating ophthalmic, otologic and
central nervous system (CNS) diseases. AGTC is a leader in
designing and constructing all critical gene therapy elements and
bringing them together to develop customized therapies that address
real patient needs. AGTC’s most advanced clinical programs leverage
its best-in-class technology platform to potentially improve vision
for patients with an inherited retinal disease. AGTC has active
clinical trials in X-linked retinitis pigmentosa (XLRP) and
achromatopsia (ACHM CNGB3 and ACHM CNGA3). Its preclinical programs
build on the Company’s industry-leading AAV manufacturing
technology and scientific expertise. AGTC is advancing multiple
important pipeline candidates to address substantial unmet clinical
need in optogenetics, otology and CNS disorders.
About XLRPXLRP is an inherited
condition that causes progressive vision loss in boys and young
men. Characteristics of the disease include night blindness in
early childhood and progressive constriction of the visual field.
In general, XLRP patients experience a gradual decline in visual
acuity over the disease course, which results in legal blindness
around the 4th or 5th decade of life. AGTC was granted U.S. Food
and Drug Administration (FDA) orphan drug designation in 2017, as
well as European Commission orphan medicinal product designation in
2016, for its gene therapy product candidate to treat XLRP caused
by mutations in the RPGR gene.
About ACHMACHM is an inherited
retinal disease, which is present from birth and is characterized
by the lack of cone photoreceptor function. The condition results
in markedly reduced visual acuity, extreme light sensitivity
causing day blindness, and complete loss of color discrimination.
Best-corrected visual acuity in persons affected by ACHM, even
under subdued light conditions, is usually about 20/200, a level at
which people are considered legally blind.
Forward-Looking StatementsThis
press release contains forward-looking statements that reflect
AGTC's plans, estimates, assumptions and beliefs, including
statements regarding the projected timing for its planned Vista
(Phase 2/3 XLRP) and Skyline (Expanded Phase 1/2 XLRP) clinical
trials, the timing for reporting data in both its Skyline and Vista
trials and the potential of its ACHM clinical programs.
Forward-looking statements include information concerning possible
or assumed future results of operations, financial guidance,
business strategies and operations, preclinical and clinical
product development and regulatory progress, potential growth
opportunities, potential market opportunities, the effects of
competition and the impact of the COVID-19 pandemic, including the
impact on AGTC’s ability to enroll patients. Forward-looking
statements include all statements that are not historical facts and
can be identified by terms such as "anticipates," "believes,"
"could," "seeks," "estimates," "expects," "intends," "may,"
"plans," "potential," "predicts," "projects," "should," "will,"
"would" or similar expressions and the negatives of those terms.
Actual results could differ materially from those discussed in the
forward-looking statements, due to a number of important factors.
Risks and uncertainties that may cause actual results to differ
materially include, among others: gene therapy is still novel with
only a few approved treatments so far; AGTC cannot predict when or
if it will obtain regulatory approval to commercialize a product
candidate or receive reasonable reimbursement; uncertainty inherent
in clinical trials and the regulatory review process; risks and
uncertainties associated with drug development and
commercialization; the direct and indirect impacts of the ongoing
COVID-19 pandemic on the Company’s business, results of operations,
and financial condition; factors that could cause actual results to
differ materially from those described in the forward-looking
statements are set forth under the heading "Risk Factors" in AGTC’s
most recent annual and subsequently filed quarterly reports filed
with the SEC. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Also, forward-looking
statements represent management's plans, estimates, assumptions and
beliefs only as of the date of this release. Except as required by
law, we assume no obligation to update these forward-looking
statements publicly or to update the reasons actual results could
differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future.
APPLIED GENETIC TECHNOLOGIES
CORPORATIONCONDENSED BALANCE
SHEETS(Unaudited)
In thousands, except per share data |
|
December 31, 2020 |
|
|
June 30, 2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,108 |
|
|
$ |
38,463 |
|
Investments |
|
|
33,989 |
|
|
|
41,995 |
|
Prepaid and other current assets |
|
|
2,080 |
|
|
|
2,506 |
|
Total current assets |
|
|
55,177 |
|
|
|
82,964 |
|
Property and equipment,
net |
|
|
4,095 |
|
|
|
4,311 |
|
Intangible assets, net |
|
|
1,194 |
|
|
|
1,098 |
|
Investment in Bionic Sight,
LLC |
|
|
8,046 |
|
|
|
8,096 |
|
Right-of-use assets –
operating leases |
|
|
3,249 |
|
|
|
3,422 |
|
Right-of-use asset – finance
lease |
|
|
57 |
|
|
|
80 |
|
Other assets |
|
|
151 |
|
|
|
348 |
|
Total assets |
|
$ |
71,969 |
|
|
$ |
100,319 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,775 |
|
|
$ |
1,355 |
|
Accrued and other liabilities |
|
|
11,352 |
|
|
|
10,502 |
|
Lease liabilities – operating |
|
|
1,067 |
|
|
|
1,058 |
|
Lease liability – finance |
|
|
50 |
|
|
|
48 |
|
Total current liabilities |
|
|
14,244 |
|
|
|
12,963 |
|
Lease liabilities – operating,
net of current portion |
|
|
3,723 |
|
|
|
4,070 |
|
Lease liability – finance, net
of current portion |
|
|
13 |
|
|
|
38 |
|
Long-term debt, net of debt
discounts and deferred financing fees |
|
|
9,844 |
|
|
|
9,677 |
|
Other liabilities |
|
|
2,623 |
|
|
|
2,555 |
|
Total liabilities |
|
|
30,447 |
|
|
|
29,303 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
25 |
|
|
|
25 |
|
Additional paid-in capital |
|
|
253,990 |
|
|
|
252,519 |
|
Treasury stock at cost |
|
|
(211 |
) |
|
|
(88 |
) |
Accumulated deficit |
|
|
(212,282 |
) |
|
|
(181,440 |
) |
Total stockholders’ equity |
|
|
41,522 |
|
|
|
71,016 |
|
Total liabilities and
stockholders’ equity |
|
$ |
71,969 |
|
|
$ |
100,319 |
|
APPLIED GENETIC TECHNOLOGIES
CORPORATIONCONDENSED STATEMENTS OF
OPERATIONS(Unaudited)
|
|
Three MonthsEnded December
31, |
|
|
Six MonthsEnded December 31, |
|
In thousands, except per share data |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and milestone revenue |
|
$ |
— |
|
|
$ |
2,297 |
|
|
$ |
— |
|
|
$ |
2,297 |
|
Grant revenue |
|
|
— |
|
|
|
156 |
|
|
|
— |
|
|
|
156 |
|
Total revenue |
|
|
— |
|
|
|
2,453 |
|
|
|
— |
|
|
|
2,453 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
11,811 |
|
|
|
8,375 |
|
|
|
23,437 |
|
|
|
17,017 |
|
General and administrative and other |
|
|
3,304 |
|
|
|
3,008 |
|
|
|
6,740 |
|
|
|
6,356 |
|
Total operating expenses |
|
|
15,115 |
|
|
|
11,383 |
|
|
|
30,177 |
|
|
|
23,373 |
|
Loss from operations |
|
|
(15,115 |
) |
|
|
(8,930 |
) |
|
|
(30,177 |
) |
|
|
(20,920 |
) |
Other income
(expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net |
|
|
29 |
|
|
|
336 |
|
|
|
93 |
|
|
|
782 |
|
Interest expense |
|
|
(335 |
) |
|
|
(2 |
) |
|
|
(667 |
) |
|
|
(4 |
) |
Total other income (expense), net |
|
|
(306 |
) |
|
|
334 |
|
|
|
(574 |
) |
|
|
778 |
|
Loss before provision for
income taxes |
|
|
(15,421 |
) |
|
|
(8,596 |
) |
|
|
(30,751 |
) |
|
|
(20,142 |
) |
Provision for income
taxes |
|
|
20 |
|
|
|
21 |
|
|
|
41 |
|
|
|
42 |
|
Loss before equity in net
losses of an affiliate |
|
|
(15,441 |
) |
|
|
(8,617 |
) |
|
|
(30,792 |
) |
|
|
(20,184 |
) |
Equity in net losses of an
affiliate |
|
|
(21 |
) |
|
|
(6 |
) |
|
|
(50 |
) |
|
|
(16 |
) |
Net loss |
|
$ |
(15,462 |
) |
|
$ |
(8,623 |
) |
|
$ |
(30,842 |
) |
|
$ |
(20,200 |
) |
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
25,883 |
|
|
|
18,219 |
|
|
|
25,850 |
|
|
|
18,215 |
|
Diluted |
|
|
25,883 |
|
|
|
18,219 |
|
|
|
25,850 |
|
|
|
18,215 |
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.60 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.11 |
) |
Diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.11 |
) |
IR/PR CONTACTS: David Carey (IR) or Glenn
Silver (PR)Lazar FINN PartnersT: (212) 867-1768 or (646)
871-8485david.carey@finnpartners.com or
glenn.silver@finnpartners.com
Corporate Contacts:Bill SullivanChief Financial OfficerApplied
Genetic Technologies CorporationT: (617)
843-5728bsullivan@agtc.com
Stephen PotterChief Business OfficerApplied Genetic Technologies
CorporationT: (617) 413-2754spotter@agtc.com
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