Aptinyx Reports Second Quarter 2019 Financial Results and Highlights
August 12 2019 - 6:33AM
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today reported financial
results for the second quarter of 2019 and recent highlights.
“We made substantial business and clinical progress in the
second quarter,” said Norbert Riedel, Ph.D., president and chief
executive officer at Aptinyx. “The positive results on both primary
and secondary endpoints in our Phase 2 study of NYX-2925 in
fibromyalgia have afforded us remarkable understanding of the
activity of this compound. Those results demonstrate conclusively
that NYX-2925 is not only present in the brain, but also that it
has positive activity on brain biomarkers known to be associated
with the processing of centralized pain. Moreover, both the
fibromyalgia study and the results in patients with advanced
diabetic peripheral neuropathy provide evidence that this activity
of NYX-2925 can result in improvement of pain and other
patient-reported symptoms in these disorders. We will seek to
further validate these effects on symptom alleviation in our
follow-up Phase 2 studies in both fibromyalgia and DPN, to begin in
the coming months. Along with our first-in-patient studies of
NYX-783 in PTSD, currently enrolling, and of NYX-458 in cognitive
impairment in Parkinson’s disease, to kick off later this year, we
will have four Phase 2 studies ongoing by the end of 2019 that will
offer key development insights across our pipeline over the next 12
to 24 months.”
Second Quarter 2019 and Recent Highlights
- Reported that NYX-2925 met primary and secondary
endpoints in a Phase 2 study in patients with
fibromyalgia. In June 2019, Aptinyx reported positive
results from a Phase 2 neuroimaging study of NYX-2925 in patients
with fibromyalgia. In the study, administration of NYX-2925
resulted in statistically significant effects on the primary
endpoint, neuroimaging biomarkers associated with pain processing.
NYX-2925 demonstrated statistically significant reductions in
connectivity and glutamate levels in brain regions that are known
to be involved in the processing of centralized chronic pain.
Statistically significant effects were also observed on secondary
endpoints, including improvements in patient-reported pain and
other symptoms of fibromyalgia. The company expects to initiate a
Phase 2 fibromyalgia study focused on patient-reported symptoms in
the second half of 2019.
- Reported data demonstrating robust activity of NYX-783
on alcohol-seeking behavior and relapse-like behavior in multiple
preclinical models of alcohol use disorder. In June 2019,
Aptinyx reported findings from preclinical studies that support the
potential of NYX-783 in treating alcohol use disorder. In an
alcohol-dependence model and a stress-induced alcohol-seeking
model, rodents dosed with NYX-783 showed significantly more rapid
elimination of alcohol-seeking behavior compared to vehicle-treated
rodents. NYX-783 also led to significantly less relapse-like
behavior across both models. These data support the continued
evaluation of NYX-783 and indicate that NYX-783 may be an effective
approach to addressing alcohol abuse in patients with or without
comorbid PTSD.
Upcoming Milestones
- Initiation of Phase 2 study of NYX-2925 in patients with
painful diabetic neuropathy in 2H 2019.
- Initiation of Phase 2 study of NYX-2925 in patients with
fibromyalgia in 2H 2019.
- Initiation of Phase 2 study of NYX-458 in patients with mild
cognitive impairment in Parkinson’s disease in 2H 2019.
- Completion of, and reporting top-line data from, Phase 2
first-in-patient study of NYX-783 in PTSD in 2H 2020.
Second Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were
$124.9 million at June 30, 2019 compared to $150.6 million at
December 31, 2018.
Collaboration and Grant Revenue: Revenue was
$0.9 million for the second quarter of 2019 compared to $2.1
million for same period in 2018. Aptinyx’s revenue was primarily
derived from its research collaboration agreement with Allergan and
government grants. The decrease was primarily driven by the option
fee received in 2018 in connection with Allergan’s exercise of its
option to acquire AGN-241751. The company does not rely on these
revenues to fund its operations.
Research and Development (R&D)
Expenses: R&D expenses were $9.5 million for the
second quarter of 2019 compared to $13.7 million for the same
period in 2018. The decrease in R&D expenses was primarily due
to the completion of studies that were ongoing in the first half of
2018.
General and Administrative (G&A)
Expenses: G&A expenses were $4.2 million for the
second quarter of 2019 compared to $2.0 million for the same period
in 2018. The increase in G&A expenses was primarily driven by
$1.2 million in increased costs related to employee compensation,
including $0.9 million of additional non-cash stock-based
compensation expenses, as well as $0.9 million of increased
professional fees and insurance costs to support ongoing business
operations and compliance associated with being a publicly traded
company.
Net Loss: Net loss was $12.1 million for the
second quarter of 2019 compared to a net loss of $13.3 million for
the same period in 2018.
Conference Call
The Aptinyx management team will host a conference call and
webcast today at 8:00 a.m. ET to review its financial results and
highlights for the second quarter of 2019. To access the call,
please dial 1-866-930-5579 (domestic) or 1-409-216-0606
(international) and refer to conference ID 9072524. A live webcast
of the call will be available on the Investors & Media section
of Aptinyx’s website at https://ir.aptinyx.com. The archived
webcast will be available approximately two hours after the
conference call and for 30 days thereafter.
About Aptinyx
Aptinyx Inc. is a clinical-stage biopharmaceutical company
focused on the discovery, development, and commercialization of
proprietary synthetic small molecules for the treatment of brain
and nervous system disorders. Aptinyx has a platform for discovery
of novel compounds that work through a unique mechanism to
modulate—rather than block or over-activate—NMDA receptors and
enhance synaptic plasticity, the foundation of neural cell
communication. The company has three product candidates in clinical
development in central nervous system indications, including
chronic pain, post-traumatic stress disorder, and cognitive
impairment associated with Parkinson’s disease. Aptinyx is also
advancing additional compounds from its proprietary discovery
platform, which continues to generate a rich and diverse pipeline
of small-molecule NMDA receptor modulators with the potential to
treat an array of neurologic disorders. For more information, visit
www.aptinyx.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not
limited to, statements regarding the company’s business plans and
objectives, including future plans or expectations for the
company’s product candidates, therapeutic effects of the company’s
product candidates, expectations regarding the design,
implementation, timing, and success of its current and planned
clinical studies, the timing for the company’s receipt of data from
its clinical studies, expectations regarding its preclinical
development activities, and expectations regarding its uses and
sufficiency of capital. Risks that contribute to the uncertain
nature of the forward-looking statements include: the success,
cost, and timing of the company’s product candidate development
activities and planned clinical studies; the company’s ability to
execute on its strategy; positive results from a clinical study may
not necessarily be predictive of the results of future or ongoing
clinical studies; regulatory developments in the United States and
foreign countries; the company’s estimates regarding expenses,
future revenue, and capital requirements, and other financial
results; the company’s ability to fund operations through 2020; as
well as those risks and uncertainties set forth in the company’s
most recent Annual Report on Form 10-K and subsequent filings with
the Securities and Exchange Commission, including our upcoming
quarterly report on Form 10-Q for the period ended June 30, 2019.
All forward-looking statements contained in this press
release speak only as of the date on which they were made. Aptinyx
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
APTINYX INC. CONDENSED BALANCE SHEETS (in
thousands) (Unaudited)
Assets |
|
June 30, 2019 |
|
December 31, 2018 |
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
124,891 |
|
$ |
150,637 |
Restricted cash |
|
252 |
|
252 |
Accounts receivable |
|
450 |
|
578 |
Prepaid expenses and other
current assets |
|
2,878 |
|
1,784 |
Total current assets |
|
128,471 |
|
153,251 |
Property and equipment, net and
other long-term assets |
|
1,700 |
|
2,363 |
Total assets |
|
$ |
130,171 |
|
$ |
155,614 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current Liabilities:Accounts
payable |
|
$ |
834 |
|
$ |
1,889 |
Accrued expenses and other
current liabilities |
|
3,944 |
|
3,996 |
Total current liabilities |
|
4,778 |
|
5,885 |
Other long-term liabilities |
|
347 |
|
418 |
Total liabilities |
|
5,125 |
|
6,303 |
Stockholders’ equity |
|
125,046 |
|
149,311 |
Total liabilities and
stockholders’ equity |
|
$ |
130,171 |
|
$ |
155,614 |
APTINYX INC. CONDENSED STATEMENTS OF
OPERATIONS (in thousands, except per share data)
(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
925 |
|
|
$ |
2,017 |
|
|
$ |
1,815 |
|
|
$ |
2,951 |
|
Grant revenue |
|
|
— |
|
|
|
111 |
|
|
|
— |
|
|
|
1,642 |
|
Total revenues |
|
|
925 |
|
|
$ |
2,128 |
|
|
|
1,815 |
|
|
|
4,593 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
9,481 |
|
|
13,686 |
|
|
21,971 |
|
|
25,911 |
|
General and administrative |
|
4,171 |
|
|
2,022 |
|
|
9,896 |
|
|
4,071 |
|
Total operating expenses |
|
13,652 |
|
|
15,708 |
|
|
31,867 |
|
|
29,982 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(12,727 |
) |
|
(13,580 |
) |
|
(30,052 |
) |
|
(25,389 |
) |
Other income |
|
596 |
|
|
245 |
|
|
1,210 |
|
|
382 |
|
Net loss and comprehensive
loss |
|
$ |
(12,131 |
) |
|
$ |
(13,335 |
) |
|
$ |
(28,842 |
) |
|
$ |
(25,007 |
) |
Net loss per share - basic and
diluted |
|
$ |
(0.36 |
) |
|
$ |
(1.83 |
) |
|
$ |
(0.86 |
) |
|
$ |
(3.95 |
) |
Weighted average shares
outstanding - basic and diluted |
|
33,493 |
|
|
7,275 |
|
|
33,442 |
|
|
6,332 |
|
Investor & Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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