Enrollment on track in both Phase 2b studies of
NYX-2925 in chronic pain—data readouts expected 1H 2022
Preparing for NYX-783 Phase 2b PTSD study
following recent FDA meeting—study initiation expected in 2H
2021
Recommenced Phase 2 study of NYX-458 in
patients with cognitive impairment—data readout expected 2H
2022
$146.8 million cash position expected to
support operations through multiple Phase 2 readouts and into
2023
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
nervous system disorders, today reported financial results for the
first quarter of 2021 and highlighted recent progress across the
company’s pipeline of novel, clinical-stage, NMDA receptor
modulators.
“We have made excellent progress across our clinical-stage
programs over the past few months,” said Norbert Riedel, Ph.D.,
chief executive officer of Aptinyx. “This progress was exemplified
by our positive meeting with the FDA regarding our development of
NYX-783 in PTSD, and the recommencement of our Phase 2 study of
NYX-458 in patients with Parkinson’s disease and dementia with Lewy
bodies. In conjunction with the continued execution across our two
chronic pain studies, in which patient enrollment remains on track,
these important milestones position us well to continue advancing
our novel therapeutic candidates. We anticipate that our strong
financial position will fund the company through multiple Phase 2
clinical study readouts in 2022 and into 2023.”
First Quarter 2021 and Recent Clinical Program
Highlights
- Conducted Type C meeting with FDA to discuss future
development of NYX-783 in PTSD. In April, Aptinyx met with the
U.S. Food and Drug Administration (FDA) to discuss its development
plans for NYX-783 in PTSD, including the design of a planned Phase
2b study. Based on the meeting, the company intends to finalize the
design of the planned Phase 2b study such that, if the data are
positive, it could be positioned for potential FDA consideration as
one of the two well-controlled studies required for registration.
Any such consideration would be a matter for review at the FDA’s
discretion following the completion of the study. The company
expects to provide more information regarding the Phase 2b study
design at a later date and to initiate the Phase 2b study in the
second half of 2021.
- Presented additional positive data from exploratory Phase 2
study of NYX-783 in PTSD at the SOBP Annual Meeting. In April,
Aptinyx presented additional data from its completed exploratory
Phase 2 study of NYX-783 in patients with PTSD at the Society of
Biological Psychiatry Annual Meeting. These additional data and
analyses from Stage 1 of the study had not been previously
disclosed:
- A significantly greater proportion (p<0.05) of patients
achieved a Clinically Reliable Change (improvement of ≥13 points on
the CAPS-5 Total score) in the 50 mg treatment group compared to
placebo.
- When accounting for baseline imbalances across treatment groups
in patients’ time since trauma, the percentage improvement on the
CAPS-5 Total score for the NYX-783 50 mg group was significantly
greater than that in the placebo group (p<0.05).
- Recommenced exploratory Phase 2 study of NYX-458 in patients
with cognitive impairment. In March, Aptinyx announced the
recommencement of its exploratory Phase 2 study of NYX-458 in
patients with cognitive impairment associated with Parkinson’s
disease and dementia with Lewy bodies. Enrollment in this study had
previously been suspended due to the escalation of the COVID-19
pandemic. This exploratory Phase 2 study is designed to detect
signals of therapeutically relevant activity across various
measures of cognitive performance, as well as assess the safety and
tolerability profile of NYX-458 in patients. The company expects to
enroll approximately 100 patients in the study and anticipates
reporting data from the study in the second half of 2022.
- Announced election of Dr. Joan W. Miller to the Board of
Directors. In May, Aptinyx announced the election of Joan W.
Miller, M.D. to its board of directors. Dr. Miller currently serves
as the David Glendenning Cogan Professor of Ophthalmology and Chair
of the Department of Ophthalmology at Harvard Medical School, as
well as Chief of Ophthalmology at both Massachusetts Eye and Ear
and Massachusetts General Hospital. Dr. Miller brings extensive
experience in academic and medical leadership, clinical
development, and clinical research to Aptinyx’s board.
Upcoming Milestones
- Initiation of Phase 2b study of NYX-783 in patients with PTSD –
2H 2021
- Data readout from Phase 2b study of NYX-2925 in patients with
fibromyalgia – 1H 2022
- Data readout from Phase 2b study of NYX-2925 in patients with
painful DPN – 1H 2022
- Data readout from exploratory Phase 2 study of NYX-458 in
cognitive impairment – 2H 2022
First Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents were $146.8
million at March 31, 2021 compared to $141.0 million at December
31, 2020. Aptinyx expects its current cash balance to support
anticipated operations into 2023.
Collaboration Revenue: Revenue was $1.0 million for the
first quarter of 2021 compared to $0.8 million for same period in
2020. Aptinyx’s revenue was derived from its research collaboration
agreement with Allergan, a subsidiary of AbbVie. The company does
not rely on these revenues to fund its operations.
Research and Development (R&D) Expenses: R&D
expenses were $10.3 million for the first quarter of 2021 as
compared to $11.1 million for the same period in 2020. The decrease
in R&D expenses was primarily driven by the completion of the
exploratory Phase 2 study of NYX-783 in PTSD in October 2020 and
the temporary suspension of enrollment in the exploratory Phase 2
study of NYX-458 in cognitive impairment—the latter of which
recommenced in March. The decrease was partially offset by
increased costs related to the recommencement of the company’s two
Phase 2b studies of NYX-2925 in chronic pain.
General and Administrative (G&A) Expenses: G&A
expenses were $5.0 million for the first quarter of 2021 as
compared to $4.9 million for the same period in 2020.
Net Loss: For the first quarter of 2021, net loss was
$14.2 million compared to a net loss of $14.7 million for the first
quarter 2020.
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 first quarter of 2021 and subsequent period. To
access the call, please dial (833) 772-0394 (domestic) or (236)
738-2205 (international) and refer to conference ID 3628539. 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. 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-2925, NYX-783, or NYX-458, including
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, 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, including the operational runway of its
current cash balance, 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 2023; 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 March 31, 2021. 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
March 31, 2021
December 31, 2020
Current Assets:
Cash and cash equivalents
$
146,810
$
141,028
Restricted cash
179
179
Accounts receivable
0
257
Prepaid expenses and other current
assets
5,421
8,140
Total current assets
152,410
149,604
Property and equipment, net and other
long-term assets
480
1,002
Total assets
$
152,890
$
150,606
Liabilities and stockholders’
equity
Current Liabilities:
Accounts payable
$
1,674
$
1,209
Accrued expenses and other current
liabilities
2,204
3,374
Total current liabilities
3,878
4,583
Other long-term liabilities
71
114
Total liabilities
3,949
4,697
Stockholders’ equity
148,941
145,909
Total liabilities and stockholders’
equity
$
152,890
$
150,606
APTINYX INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except per
share data)
(unaudited)
Three Months Ended March
31,
2021
2020
Revenues
Collaboration revenue
$
1,000
$
818
Operating expenses
Research and development
10,314
11,055
General and administrative
4,976
4,899
Total operating expenses
15,290
15,954
Loss from operations
(14,290
)
(15,136
)
Other income
64
426
Net loss and comprehensive loss
$
(14,226
)
$
(14,710
)
Net loss per share - basic and diluted
$
(0.22
)
$
(0.34
)
Weighted average shares outstanding -
basic and diluted
66,043
43,835
Source: Aptinyx Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210513006003/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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