Aptinyx Reports on Fourth Quarter and Full Year 2022 Results and Highlights and Review of Strategic Alternatives
March 30 2023 - 4:05PM
Business Wire
Aptinyx Inc. (Nasdaq: APTX) today reported recent business
updates and financial results for the fourth quarter and full year
2022.
Recent Business Updates
- In March, Aptinyx completed an analysis of the data from the
first 100 patients enrolled in its Phase 2b clinical study of
NYX-783 50 mg in patients with post-traumatic stress disorder
(PTSD). The study was halted in February prior to its completion in
support of the company’s preservation of capital. In the analysis,
NYX-783 did not demonstrate sufficient improvement on the study’s
primary endpoint to support continued advancement of the
development program by Aptinyx.
- In March, Aptinyx engaged Ladenburg Thalmann as its exclusive
financial advisor to assist in the company’s exploration and
evaluation of strategic alternatives.
- In March, Aptinyx announced a reduction in its workforce by
approximately 60% to reduce the company’s operating costs and
better align its workforce with the needs of its business as the
company assesses strategic alternatives.
- In February, Aptinyx announced results from its Phase 2
clinical study of NYX-458 in patients with cognitive impairment
associated with Parkinson’s disease and dementia with Lewy bodies.
Across the overall study population, NYX-458 did not demonstrate
clinically meaningful improvements over placebo on the study’s
efficacy endpoints. The results do not support further advancement
of the development program by the company.
- Aptinyx’s NMDA receptor positive allosteric modulator, NYX-783,
is under development as a treatment for opioid use disorder (OUD),
supported by a $5.6 million grant issued to researchers at Yale
University School of Medicine. The 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), and funds the research and development of
NYX-783 for the treatment of OUD. A Phase 1 drug-drug interaction
study is ongoing and is being administered by the Yale
Interdisciplinary Stress Center through a research collaboration
with Aptinyx.
Fourth Quarter and Full Year 2022 Financial Results
Cash Position: Cash and cash equivalents were $56.2
million at December 31, 2022, compared to $106.1 million at
December 31, 2021. The company had $25.0 million of debt principal
under a capital credit facility with K2 HealthVentures, which
remains currently outstanding.
Collaboration Revenue: Revenue was $0.0 million for the
fourth quarter and full year 2022, as compared to $0.0 million and
$1.0 million for same periods in 2021.
Research and Development (R&D) Expenses: R&D
expenses were $7.2 million and $42.7 million for the fourth quarter
and full year 2022, respectively, as compared to $14.1 million and
$55.4 million for same periods in 2021. The decrease in R&D
expenses during 2022 was primarily driven by decreased costs
associated with the close out of clinical development activities
across three Phase 2 clinical studies.
General and Administrative (G&A) Expenses: G&A
expenses were $4.2 million and $19.8 million for the fourth quarter
and full year 2022, respectively, as compared to $5.1 million and
$20.1 million for the same periods in 2021.
Net Loss: Net loss was $12.1 million for the fourth
quarter of 2022 compared to a net loss of $19.6 million for the
same period in 2021. For the year ended December 31, 2022, net loss
was $64.8 million, or basic and diluted net loss per share
attributable to common stockholders of $0.96, compared to a net
loss of $74.9 million, or basic and diluted net loss per share
attributable to common stockholders of $1.11, for the year ended
December 31, 2021.
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, the company’s ongoing
evaluation of strategic alternatives, including future plans or
expectations for NYX-783 and NYX-458, the safety, therapeutic
effects, and stage of development 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 providing updated guidance with
respect thereto, the timing for the company’s receipt and
announcement of data from its clinical studies, the timing and
outcome of discussions with FDA and other regulatory agencies,
expectations regarding its preclinical development activities,
expectations regarding its uses and sufficiency of capital, the
company’s growth and the anticipated contribution of its executive
officers and management to its operations and progress, and its
expectations regarding its uses of capital and expenses, 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 trials, business operations, and
ability to raise additional capital; the success, cost, and timing
of the company’s product candidate development activities and
clinical studies; the company’s ability to execute on its strategy;
including its ongoing strategic evaluation; the company’s estimates
regarding expenses, future revenue, and capital requirements; as
well as those risks and uncertainties set forth in the company’s
most recent quarterly report on Form 10-Q and subsequent filings
with the Securities and Exchange Commission, including our upcoming
Annual Report on Form 10-K for the year ended December 31, 2022.
Potential strategic alternatives that may be explored or evaluated
as part of the company’s ongoing evaluation include the potential
for a merger, business combination, investment into the company,
asset sale or other strategic transaction. No timetable has been
established for the completion of this process, and the we do not
expect to disclose developments unless and until the Board of
Directors has concluded that disclosure is appropriate or required.
All forward-looking statements contained in this press release
speak only as of the date on which they were made. Aptinyx
disclaims any intention 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
December 31, 2022
December 31, 2021
Current Assets:
Cash and cash equivalents
$
56,205
$
106,124
Restricted cash
179
197
Prepaid expenses and other current
assets
7,646
8,422
Total current assets
64,030
114,743
Property and equipment and other long-term
assets
2,654
185
Total assets
$
66,684
$
114,928
Liabilities and stockholders’
equity
Current Liabilities:
Accounts payable
$
724
$
622
Accrued expenses and other current
liabilities
2,772
5,064
Term loan, current
2,795
----
Total current liabilities
6,291
5,686
Other long-term liabilities
22,108
14,486
Total liabilities
28,399
20,172
Stockholders’ equity
38,285
94,756
Total liabilities and stockholders’
equity
$
66,684
$
114,928
APTINYX INC. CONDENSED
STATEMENTS OF OPERATIONS (in thousands, except per share data)
(Unaudited)
Three Months Ended December
31,
Year Ended December
31,
2022
2021
2022
2021
Collaboration revenue
$
—
$
—
$
—
$
1,000
Operating expenses
Research and development
7,230
14,056
42,748
55,444
General and administrative
4,196
5,116
19,819
20,090
Total operating expenses
11,426
19,172
62,567
75,534
Loss from operations
(11,426
)
(19,172
)
(62,567
)
(74,534
)
Other income (expense)
(627
)
(438
)
(2,282
)
(352
)
Net loss and comprehensive loss
$
(12,053
)
$
(19,610
)
$
(64,849
)
$
(74,886
)
Net loss per share - basic and diluted
$
(0.18
)
$
(0.29
)
$
(0.96
)
$
(1.11
)
Weighted average shares outstanding -
basic and diluted
67,716
67,716
67,716
67,220
Source: Aptinyx Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20230330005712/en/
Investor & Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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