Completed enrollment in Phase 2 exploratory
study of NYX-783 in PTSD; data readout expected in 4Q 2020
Recommencement of Phase 2 studies of NYX-2925
in chronic pain expected soon
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 second quarter of 2020 and highlighted recent
progress across the company’s clinical-stage pipeline of novel NMDA
receptor modulators.
“Despite the continuing COVID-19 health emergency, we have made
important progress in advancing our pipeline of clinical-stage
product candidates over the past few months,” said Norbert Riedel,
Ph.D., president and chief executive officer of Aptinyx. “The
recent completion of enrollment in our Phase 2 exploratory study of
NYX-783 in patients with PTSD underscores this progress, as well as
the ability of our team to operate in this new, highly complex
environment. We are also pleased to announce that we will resume
our studies of NYX-2925 in chronic pain in the very near future.
With the resumption of these studies imminent, we expect that our
current cash balance will support multiple potentially catalytic
Phase 2 data readouts across our pipeline of innovative CNS product
candidates.”
Second Quarter 2020 and Recent Highlights
- Completed enrollment in Phase 2 exploratory study of NYX-783
in post-traumatic stress disorder (PTSD). In June, Aptinyx
announced the completion of enrollment in its Phase 2 exploratory
study of NYX-783 in patients with PTSD. In total, 160 patients were
enrolled in the study. The company anticipates reporting data from
this first-in-patient Phase 2 exploratory study in the fourth
quarter of 2020.
- Hosted virtual R&D Day highlighting the company’s
development efforts in PTSD. In August, Aptinyx hosted a PTSD-focused
R&D Day. The program featured presentations by the Aptinyx
management team as well as Murray Stein, MD, MPH, Distinguished
Professor of Psychiatry at UCSD and psychiatrist at the VA San
Diego Healthcare System.
- Aptinyx added to the Russell 2000® Index. Effective June
29, 2020, Aptinyx was added as a member of the US small-cap Russell
2000® Index. Russell US Indexes are widely used by investment
managers and institutional investors as the basis for index funds
and as benchmarks for active investment strategies.
Expected Upcoming Milestones
- Recommencement of Phase 2 study of NYX-2925 in patients with
fibromyalgia – September 2020.
- Reporting data from first-in-patient Phase 2 exploratory study
of NYX-783 in patients with PTSD – 4Q 2020.
- Recommencement of Phase 2 study of NYX-2925 in patients with
painful diabetic peripheral neuropathy – late 2020/early 2021.
Second Quarter 2020 Financial Results
Cash Position: Cash and cash equivalents were $115.9
million at June 30, 2020, compared to $98.8 million at December 31,
2019. Aptinyx expects its current cash balance to support
anticipated operations into 2022 and fund multiple Phase 2 data
readouts.
Collaboration Revenue: Revenue was $0.5 million for the
second quarter of 2020, compared to $0.9 million for same period in
2019. Aptinyx’s revenue was derived from its research collaboration
agreement (RCA) with Allergan, now a wholly owned subsidiary of
AbbVie. In accordance with the terms of the RCA, jointly funded
research activities, and associated payments by Allergan/AbbVie to
Aptinyx, are expected to come to their contractual conclusion at
the end of August 2020. The company does not rely on these revenues
to fund its continuing and expected future operations.
Research and Development (R&D) Expenses: R&D
expenses were $8.4 million for the second quarter of 2020, compared
to $9.5 million for the same period in 2019. The decrease in
R&D expenses was primarily driven by a decrease in personnel
and related support costs.
General and Administrative (G&A) Expenses: G&A
expenses were $4.8 million for the second quarter of 2020, compared
to $4.2 million for the same period in 2019. The increase of $0.6
million was primarily due to non-cash stock-based employee
compensation expenses.
Net Loss: Net loss was $12.5 million for the second
quarter of 2020, compared to a net loss of $12.1 million for the
second quarter of 2019.
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 second quarter of 2020 and subsequent period. To
access the call, please dial (833) 772-0394 (domestic) or (236)
738-2205 (international) and refer to conference ID 5118404. 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 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-2925, NYX-783, and NYX-458, 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, including the
timing of recommencement of clinical studies, effects of the
COVID-19 pandemic on patient enrollment and the expected timing of
study completion, and data reporting, the timing for the company’s
receipt and announcement of data from its clinical studies,
expectations regarding its preclinical development activities,
expectations regarding its uses and sufficiency of capital and the
effect of the COVID-19 pandemic on the foregoing. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the effect of the COVID-19 pandemic on our
business and financial results, including with respect to
disruptions to our 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 2022; 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, 2020. 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, 2020
December 31, 2019
Current Assets:
Cash and cash equivalents
$
115,878
$
98,849
Restricted cash
179
179
Accounts receivable
490
444
Prepaid expenses and other current
assets
3,688
5,637
Total current assets
120,235
105,109
Property and equipment, net and other
long-term assets
1,182
1,370
Total assets
$
121,417
$
106,479
Liabilities and stockholders’
equity
Current Liabilities:
Accounts payable
$
1,532
$
1,555
Accrued expenses and other current
liabilities
2,384
3,341
Total current liabilities
3,916
4,896
Other long-term liabilities
193
272
Total liabilities
4,109
5,168
Stockholders’ equity
117,308
101,311
Total liabilities and stockholders’
equity
$
121,417
$
106,479
APTINYX INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except per
share data)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2020
2019
2020
2019
Revenues
Total revenue
$
490
$
925
$
1,308
$
1,815
Operating expenses
Research and development
8,365
9,481
19,420
21,971
General and administrative
4,770
4,171
9,669
9,896
Total operating expenses
13,135
13,652
29,089
31,867
Loss from operations
(12,645
)
(12,727
)
(27,781
)
(30,052
)
Other income
128
596
554
1,210
Net loss and comprehensive loss
$
(12,517
)
$
(12,131
)
$
(27,227
)
$
(28,842
)
Net loss per share - basic and diluted
$
(0.27
)
$
(0.36
)
$
(0.61
)
$
(0.86
)
Weighted average shares outstanding -
basic and diluted
45,680
33,493
44,757
33,442
Source: Aptinyx Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200813005681/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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