Company expects to report results from Phase 2
study of NYX-458 in cognitive impairment in 1Q 2023
$5.6 million NIH grant finalized for research
and development of NYX-783 in opioid use disorder
$67 million cash balance provides operational
runway into 2024 and enables readouts from multiple Phase 2
studies
Management to host conference call today at
5:00 p.m. ET
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 2022 and provided key business
updates across the company’s clinical-stage pipeline of novel NMDA
receptor modulators.
“During the quarter, we took decisive steps to focus our
resources on enabling data readouts from our ongoing clinical
studies and maintaining cash runway into 2024,” said Andy Kidd,
M.D., president and chief executive officer of Aptinyx. “Our
pipeline continues to progress towards meaningful data catalysts
next year, beginning with our Phase 2 study of NYX-458 in cognitive
impairment associated with Parkinson’s disease. The study is
robustly designed to characterize the therapeutic effects of
NYX-458 and will measure improvements in cognitive deficits that
impact nearly half of all patients with Parkinson’s disease. We
look forward to reporting data from this study in the first quarter
of next year, as well as to data from our Phase 2b study of NYX-783
in PTSD expected later in the year. We are also pleased to be
expanding our pipeline through the clinical evaluation of NYX-783
in opioid use disorder, to be conducted by skilled researchers at
Yale University School of Medicine and funded by an NIH grant.”
Recent Business
Highlights
- Readout of Phase 2 study of NYX-458 in cognitive impairment
expected in 1Q 2023.
- In August 2022, Aptinyx announced the completion of enrollment
of 99 patients in its ongoing Phase 2 study of NYX-458 in cognitive
impairment associated with Parkinson’s disease (PD) and dementia
with Lewy bodies (DLB).
- The majority of patients enrolled in the study have a diagnosis
of mild cognitive impairment or dementia associated with PD, with
fewer patients diagnosed with DLB.
- The Phase 2 study is a randomized, double-blind,
parallel-design, placebo-controlled study to evaluate the efficacy
and safety of 12 weeks of daily dosing of NYX-458.
- The primary endpoint in the study is overall safety and
tolerability of NYX-458.
- Secondary endpoints are evaluated using a battery of six
computerized neurocognitive tests (offered by Cogstate, a leading
provider of brain health assessments) selected for their relevance
to the specific cognitive domains affected by PD. Improvements
relative to baseline and placebo will be measured on:
- A composite score of the Cogstate PD cognitive battery of
tests
- Four sub-scores for each of the cognitive domains assessed
(Attention, Learning & Memory, Working Memory, and Executive
Function), each comprising a subset of the Cogstate PD cognitive
battery of tests
- Each of the six individual tests in the Cogstate PD cognitive
battery, which include:
- Continuous Paired Associate Learning Test
- Groton Maze Learning Test
- Identification Test
- International Shopping List Test
- One Back Test
- Two Back Test
- Two additional exploratory endpoints evaluate patients’
everyday cognitive function:
- Everyday Cognition-12 (Ecog-12) scale, assessing cognitively
relevant functional abilities
- Penn Parkinson’s Daily Activities Questionnaire (PDAQ-15),
assessing daily function dependent on cognition
- Enrollment in Phase 2b study of NYX-783 in post-traumatic
stress disorder (PTSD) is progressing.
- The company’s ongoing Phase 2b study will enroll approximately
300 patients with PTSD, randomized to receive oral doses of NYX-783
50 mg or placebo once daily over a 10-week treatment period.
- The primary endpoint in the study is the change from baseline
in the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)
total score.
- Key secondary endpoints include measures of clinicians’ and
patients’ global impressions of severity and improvement (CGI-S,
CGI-I, PGI-S, PGI-I).
- The company expects to report data from the Phase 2b study in
the second half of 2023.
- $5.6 million NIH grant finalized for research and
development of NYX-783 for the treatment of opioid use disorder
(OUD).
- In November, the company announced the finalization of a grant,
issued to researchers at Yale University School of Medicine,
funding the research and development of NYX-783 for the treatment
of OUD.
- The $5.6 million grant was awarded under the National
Institutes of Health (NIH) Helping to End Addiction Long-term
(HEAL) Initiative, administered by the National Institute on Drug
Abuse (NIDA).
- The first clinical study funded by the grant will be a
randomized, double-blind, placebo-controlled, Phase 1 drug-drug
interaction study to assess the safety, tolerability, and
pharmacokinetics of NYX-783 in combination with oxycodone in
individuals who use opioids.
- The primary outcomes of the study will evaluate a variety of
safety-related measures.
- Secondary outcome measures will evaluate opiate withdrawal and
symptom scales.
- The study will be administered by the Yale Interdisciplinary
Stress Center through a research collaboration with Aptinyx.
- The researchers at Yale University School of Medicine expect to
complete the Phase 1 study in the second half of 2023.
Pipeline Updates
- NYX-2925 Phase 2b fibromyalgia study results reported.
- In August 2022, Aptinyx announced that the primary endpoint was
not achieved in its Phase 2b study of NYX-2925 in patients with
fibromyalgia.
- NYX-2925 was well tolerated in the study, with no concerning
safety issues observed.
- The company does not intend to dedicate additional resources to
the development of NYX-2925 for chronic pain.
Third Quarter 2022 Financial Results
Cash Position: Cash and cash equivalents were $66.5
million as of September 30, 2022, compared to $106.1 million as of
December 31, 2021. Aptinyx expects its current cash balance to fund
readouts from each of the company’s Phase 2 clinical development
programs and support anticipated operations into 2024.
Research and Development (R&D) Expenses: Research and
development expenses were $10.0 million for the three months ended
September 30, 2022, compared to $16.2 million for the three months
ended September 30, 2021. The decrease in R&D expenses was
primarily driven by the completion of the company’s Phase 2b
studies of NYX-2925 in patients with painful diabetic peripheral
neuropathy in April 2022 and in patients with fibromyalgia in
August 2022.
General and Administrative (G&A) Expenses: General
and administrative expenses were $4.6 million for the three months
ended September 30, 2022, compared to $4.9 million for the same
period in 2021.
Net Loss: Net loss was $15.3 million for the third
quarter of 2022, compared to a net loss of $21.2 million for the
third quarter of 2021.
Conference Call
The Aptinyx management team will host a conference call and
webcast today at 5:00 p.m. ET to review its financial results and
highlights for the third quarter of 2022 and subsequent period. To
access the live conference call, please dial 844-200-6205
(domestic) or 929-526-1599 (international) and refer to conference
ID 141144. A live audio webcast of the event will be available on
the Investors & Media section of Aptinyx’s website at
https://ir.aptinyx.com. A replay of the webcast will be archived on
Aptinyx’s website for 30 days following the event.
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 multiple product candidates in
clinical development in central nervous system indications,
including cognitive impairment, post-traumatic stress disorder, and
opioid use disorder. 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
or follow Aptinyx on Twitter @Aptinyx.
Forward-Looking Statements
Statements 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 NYX-783 or NYX-458, the potential therapeutic
effects of the company’s product candidates and discovery platform,
expectations regarding the design, implementation, timing, and
success of its current and planned clinical studies, the timing for
the company’s receipt and announcement of data from its clinical
studies, and the company’s expectations regarding its uses and
sufficiency of capital, including the operational runway of its
current cash balance. Risks that contribute to the uncertain nature
of the forward-looking statements include: the effect of the
COVID-19 pandemic on the company’s business and financial results,
including with respect to disruptions to the company’s clinical
studies, business operations, and ability to raise additional
capital; 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; the
company’s ability to fund operations into 2024 and the company’s
ability to raise additional capital; 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 the company’s upcoming Quarterly
Report on Form 10-Q for the period ended September 30, 2022. 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, 2022
December 31, 2021
Current Assets:
Cash and cash equivalents
$
66,584
$
106,124
Restricted cash
179
197
Prepaid expenses and other current
assets
7,187
8,422
Total current assets
73,950
114,743
Property and equipment, net and other
long-term assets
2,255
185
Total assets
$
76,205
$
114,928
Liabilities and stockholders’
equity
Current Liabilities:
Accounts payable
$
474
$
622
Accrued expenses and other current
liabilities
2,220
5,064
Total current liabilities
2,694
5,686
Term loan, non-current
24,709
14,155
Other long-term liabilities
10
331
Total liabilities
27,413
20,172
Stockholders’ equity
48,792
94,756
Total liabilities and stockholders’
equity
$
76,205
$
114,928
APTINYX INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except per
share data)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenues
Collaboration revenue
$
—
$
—
$
—
$
1,000
Operating expenses
Research and development
10,008
16,278
35,519
41,388
General and administrative
4,649
4,928
15,622
14,974
Total operating expenses
14,657
21,206
51,141
56,362
Loss from operations
(14,657
)
(21,206
)
(51,141
)
(55,362
)
Other (income) expense, net
(208
)
(47
)
(432
)
(158
)
Interest Expense
854
72
2,088
72
Net loss and comprehensive loss
$
(15,303
)
$
(21,231
)
$
(52,797
)
$
(55,276
)
Net loss per share - basic and diluted
$
(0.23
)
$
(0.31
)
$
(0.78
)
$
(0.82
)
Weighted average shares outstanding -
basic and diluted
67,716
67,716
67,716
67,053
Source: Aptinyx Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221108006188/en/
Investor & Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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