Aptinyx Reports Third Quarter 2019 Financial Results and Highlights
13 November 2019 - 8:01AM
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 third quarter of 2019 and highlighted recent
progress across the company’s pipeline of novel NMDA receptor
modulators.
“We made significant progress in the third quarter and
subsequent period, including the initiation of two Phase 2 studies
of NYX-2925 in patients with painful DPN and fibromyalgia,” said
Norbert Riedel, Ph.D., president and chief executive officer of
Aptinyx. “By the end of the year, we will have four Phase 2 studies
ongoing, including the pain studies, our study of NYX-783 in PTSD,
and a study of NYX-458 in Parkinson’s cognitive impairment that we
will initiate very soon. We set out to build a transformative
neuroscience company, and these pipeline advances are key steps in
achieving our goal of bringing novel medicines to patients in need
of better therapeutic options.”
Third Quarter 2019 and Recent Highlights
- Initiated a Phase 2 study of NYX-2925 in patients with
painful diabetic peripheral neuropathy. Earlier today,
Aptinyx announced the initiation of a Phase 2 study evaluating the
effects of NYX-2925 in patients with painful diabetic peripheral
neuropathy (DPN). The study is evaluating daily oral dosing of
NYX-2925 50 mg compared to placebo. The primary endpoint is the
change from baseline in average daily pain score over a 12-week
period as reported on the 10-point numeric rating scale (NRS). The
company expects to report top-line results from this study in late
2020 or early 2021.
- Initiated a Phase 2 study of NYX-2925 in patients with
fibromyalgia. Earlier today, Aptinyx announced the
initiation of a Phase 2 study evaluating the effects of NYX-2925 in
patients with fibromyalgia. The study is evaluating daily oral
dosing of two dose levels of NYX-2925—50 mg and 100 mg—compared to
placebo. The primary endpoint is the change from baseline in
average daily pain score over a 12-week period as reported on the
10-point numeric rating scale (NRS). The company expects to report
top-line results from this study in the first half of 2021.
- Results of a Phase 2 fibromyalgia study of NYX-2925
were selected for a late-breaking presentation at the American
College of Rheumatology Annual Meeting (ACR/ARP). In
October 2019, Aptinyx announced that data from its Phase 2
neuroimaging study of NYX-2925 in patients with fibromyalgia were
selected to be presented in a late-breaking poster presentation at
the ACR Annual Meeting. The results of the study show that NYX-2925
had statistically significant effects on neuroimaging biomarkers
associated with central pain processing and that it significantly
improved patient-reported symptoms of fibromyalgia. The ePoster was
presented today, November 12, 2019 in Atlanta, Georgia.
- Presented preclinical data on all three clinical-stage
product candidates at the 49th Annual Meeting of the Society for
Neuroscience. In October 2019, Aptinyx announced six
presentations at the 49th Annual Meeting of the Society for
Neuroscience. The presentations exhibited preclinical data
supporting the development of each of the company’s three novel
NMDA receptor modulators, NYX-2925, NYX-783, and NYX-458, in
chronic pain, PTSD, and cognitive impairment, respectively.
- Three preclinical publications highlighted NMDA
receptor activation facilitated by NYX-2925. In September
2019, Aptinyx announced the publication of three papers in
peer-reviewed scientific journals. The publications describe the
novel mechanism of action of NYX-2925 and demonstrate that its
activation of NMDA receptors leads to enhanced synaptic plasticity,
or neuronal communication.
- Former principal deputy commissioner of the FDA, Rachel
Sherman, M.D., joined the company’s Board of Directors. In
September 2019, Aptinyx announced that Dr. Sherman joined the
company’s Board of Directors. She served at the FDA for nearly 30
years, holding roles of increasing responsibility and influence.
Dr. Sherman led numerous key initiatives credited with enhancing
product development and facilitating patient access to innovative
medicines, including expedited drug development and breakthrough
therapy designation programs and the Opioid Policy Steering
Committee.
Upcoming Milestones
- Initiation of Phase 2 study of NYX-458 in patients with mild
cognitive impairment in Parkinson’s disease in 4Q 2019.
- Completion of, and reporting data from, Phase 2
first-in-patient study of NYX-783 in PTSD in 2H 2020.
- Completion of, and reporting top-line data from, Phase 2 study
of NYX-2925 in painful DPN in late 2020 or early 2021.
- Completion of, and reporting top-line data from, Phase 2 study
of NYX-2925 in fibromyalgia in 1H 2021.
Third Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were
$114.2 million at September 30, 2019, compared to $150.6 million at
December 31, 2018. The company expects this cash balance to be
sufficient to fund anticipated operations into 2021.
Collaboration and Grant Revenue: Revenue was
$0.9 million for the third quarter of 2019 compared to $0.9 million
for same period in 2018. Aptinyx’s revenue was primarily derived
from its research collaboration agreement with Allergan. The
company does not rely on these revenues to fund its operations.
Research and Development (R&D)
Expenses: R&D expenses were $11.8 million for the
third quarter of 2019 compared to $12.0 million for the same period
in 2018. The decrease in R&D expenses was primarily driven by a
decrease of $2.2 million related to the completion of two Phase 2
studies of NYX-2925, partially offset by a $2.0 million increase in
spending related to NYX-783 and NYX-458.
General and Administrative (G&A)
Expenses: G&A expenses were $4.5 million for the
third quarter of 2019 compared to $3.8 million for the same period
in 2018. The increase in G&A expenses was primarily driven by
$0.7 million in increased expenses related to employee
compensation, as well as professional fees and insurance costs to
support ongoing business operations.
Net Loss: Net loss was $14.8 million for the
third quarter of 2019 compared to a net loss of $14.2 million for
the same period in 2018.
Conference CallThe Aptinyx management team will
host a conference call and webcast today at 5:00 p.m. EST to review
its financial results and highlights for the third quarter of 2019
and subsequent period. To access the call, please dial
1-866-930-5579 (domestic) or 1-409-216-0606 (international) and
refer to conference ID 4280058. 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 AptinyxAptinyx 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 into 2021; 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 September 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 |
September 30, 2019 |
|
December 31, 2018 |
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
114,214 |
|
$ |
150,637 |
Restricted cash |
179 |
|
252 |
Accounts receivable |
461 |
|
578 |
Prepaid expenses and other
current assets |
3,980 |
|
1,784 |
Total current assets |
118,834 |
|
153,251 |
Property and equipment, net
and other long-term assets |
1,496 |
|
2,363 |
Total assets |
$ |
120,330 |
|
$ |
155,614 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current Liabilities:Accounts
payable |
$ |
1,750 |
|
$ |
1,889 |
Accrued expenses and other
current liabilities |
5,344 |
|
3,996 |
Total current liabilities |
7,094 |
|
5,885 |
Other long-term
liabilities |
309 |
|
418 |
Total liabilities |
7,403 |
|
6,303 |
Stockholders’ equity |
112,927 |
|
149,311 |
Total liabilities and
stockholders’ equity |
$ |
120,330 |
|
$ |
155,614 |
|
|
|
|
|
|
|
APTINYX INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(in thousands, except per share data) |
(Unaudited) |
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
936 |
|
|
$ |
943 |
|
|
$ |
2,751 |
|
|
$ |
3,893 |
|
Grant revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,642 |
|
Total revenues |
|
936 |
|
|
$ |
943 |
|
|
|
2,751 |
|
|
|
5,535 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
11,761 |
|
|
11,950 |
|
|
33,732 |
|
|
37,860 |
|
General and
administrative |
4,523 |
|
|
3,782 |
|
|
14,419 |
|
|
7,853 |
|
Total operating expenses |
16,284 |
|
|
15,732 |
|
|
48,151 |
|
|
45,713 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(15,348 |
) |
|
(14,789 |
) |
|
(45,400 |
) |
|
(40,178 |
) |
Other income |
558 |
|
|
608 |
|
|
1,768 |
|
|
990 |
|
Net loss and comprehensive
loss |
$ |
(14,790 |
) |
|
$ |
(14,181 |
) |
|
$ |
(43,632 |
) |
|
$ |
(39,188 |
) |
Net loss per share - basic and
diluted |
$ |
(0.44 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.30 |
) |
|
$ |
(2.48 |
) |
Weighted average shares
outstanding - basic and diluted |
33,646 |
|
|
33,191 |
|
|
33,510 |
|
|
15,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor & Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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