Significant development progress across
clinical-stage pipeline programs, with multiple clinical and
regulatory milestones expected over the next 18 months
Recommenced patient recruitment in Phase 2b
clinical study of NYX-2925 in patients with fibromyalgia
Near-term recommencements planned for Phase 2b
clinical study in painful DPN and exploratory Phase 2 study in
cognitive impairment
Reported positive results from exploratory
Phase 2 clinical study of NYX-783 in patients with PTSD
Strengthened cash position through common stock
offering, expected to provide operational runway into 2023 through
multiple clinical data readouts
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 2020 and highlighted recent
progress across the company’s clinical-stage pipeline of novel NMDA
receptor modulators.
“I am very pleased with the remarkable progress we have made
over the past several months despite the negative impact of
COVID-19, including our decisive response to the emergence of the
pandemic, the positive progress and results across our clinical
studies, and the completion of a financing that funds all of our
pipeline programs,” said Norbert Riedel, Ph.D., president and chief
executive officer of Aptinyx. “While it has been a trying year with
unexpected hurdles, I am very proud of the persistence shown by our
team to work through such challenges and stay focused on advancing
these important novel therapies in development. We resumed our
fibromyalgia study and are poised to restart our studies in painful
DPN and cognitive impairment in the coming months. In addition, we
recently reported positive results from our Phase 2 clinical study
of NYX-783 in patients with post-traumatic stress disorder. The
PTSD study represents the third Phase 2 study demonstrating the
therapeutic potential of compounds from our platform and further
validates our mechanism of NMDA receptor modulation in the
treatment of disorders of the central nervous system. We continue
to be well served by our strong cash balance, which was bolstered
by our recent financing and which we expect will provide
operational runway into 2023, enabling the achievement of multiple
clinical and regulatory milestones across our pipeline.”
Third Quarter 2020 and Recent Highlights
- Recommenced patient recruitment in Phase 2b study of
NYX-2925 in patients with fibromyalgia – In September, Aptinyx
announced the re-activation of study sites and recommencement of
patient recruitment in its Phase 2b clinical study of NYX-2925 in
patients with fibromyalgia. Enrollment in the study had been
suspended in March 2020 due to the escalation of the COVID-19
pandemic in the United States.
- Reported positive results from Phase 2 exploratory study of
NYX-783 in patients with post-traumatic stress disorder (PTSD)
– In October, Aptinyx announced
positive results from the initial exploratory Phase 2 clinical
study of its novel NMDA receptor modulator, NYX-783, in 153
patients with PTSD. In the Phase 2 clinical study, NYX-783
demonstrated clinically meaningful and stasticically significant
effects across multiple endpoints with a favorable adverse event
and tolerability profile. Based on these results, the company
expects to initiate a registration-supportive study in the second
half of 2021. Summary of study results:
- Clinically meaningful improvement from baseline on CAPS-5 Total
score observed in 50 mg dose arm
- Statistically significant separation of 50 mg from placebo
achieved on multiple measures of responder rate on CAPS-5 Total
score
- Clinically meaningful and statistically significant improvement
on CAPS-5 Arousal and Reactivity symptom cluster score observed
with NYX-783
- Clear dose response observed with 50 mg dose group performing
better overall compared to 10 mg dose group
- Favorable tolerability and adverse event profile observed in
the study
- Strengthened the company’s financial position through the
completion of a $48.3 million common stock offering. In
October, Aptinyx announced the closing of a public offering of
common stock with gross proceeds totaling $48.3 million, inclusive
of the full exercise of the underwriters’ option to purchase
additional shares and before deducting underwriting discounts and
commissions and offering expenses. The company’s current cash
balance, inclusive of the net proceeds from the offering, is
expected to provide financial support into 2023 and enable
completion of multiple ongoing Phase 2 clinical studies.
Expected Upcoming Milestones
- Recommencement of Phase 2b clinical study of NYX-2925 in
patients with painful diabetic peripheral neuropathy – 4Q 2020
- Recommencement of Phase 2 exploratory clinical study of NYX-458
in patients with cognitive impairment associated with Parkinson’s
disease – 1Q 2021
- Meeting with FDA to discuss future development and registration
pathway for NYX-783 in PTSD – 1H 2021
- Initiation of registration-supportive clinical study of NYX-783
in patients with PTSD – 2H 2021
- Reporting of data from Phase 2b clinical study of NYX-2925 in
patients with fibromyalgia – 1H 2022
- Reporting of data from Phase 2b clinical study of NYX-2925 in
patients with painful DPN – 1H 2022
Third Quarter 2020 Financial Results
Cash Position: Cash and cash equivalents were $103.8
million at September 30, 2020, compared to $98.8 million at
December 31, 2019. Together with the net proceeds from the common
stock offering in October 2020, pro forma cash and cash equivalents
amount to approximately $148 million. Aptinyx expects its current
cash balance to support anticipated operations into 2023 and fund
completion of multiple clinical studies.
Collaboration Revenue: Revenue was $0.3 million for the
third 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 the associated payments by Allergan/AbbVie
to Aptinyx—came 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: Research and
development expenses were $6.6 million for the three months ended
September 30, 2020, compared to $11.8 million for the three months
ended September 30, 2019. The decrease in R&D expenses was
primarily due to a decrease in personnel costs as well as a
decrease in clinical operations expenditures.
General and Administrative (G&A) Expenses: General
and administrative expenses were $5.0 million for the three months
ended September 30, 2020, compared to $4.5 million for the same
period in 2019. The $0.5 million increase in G&A expenses was
due to non-cash stock-based compensation expense.
Net Loss: Net loss was $11.3 million for the third
quarter of 2020, compared to a net loss of $14.8 million for the
third 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 third 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 9186375. 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, including the
timing and pivotal nature of a study of NYX-783, 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,
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 September 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
September 30, 2020
December 31, 2019
Current Assets:
Cash and cash equivalents
$
103,810
$
98,849
Restricted cash
179
179
Accounts receivable
257
444
Prepaid expenses and other current
assets
8,836
5,637
Total current assets
113,082
105,109
Property and equipment, net and other
long-term assets
1,125
1,370
Total assets
$
114,207
$
106,479
Liabilities and stockholders’
equity
Current Liabilities:
Accounts payable
$
986
$
1,555
Accrued expenses and other current
liabilities
3,281
3,341
Total current liabilities
4,267
4,896
Other long-term liabilities
154
272
Total liabilities
4,421
5,168
Stockholders’ equity
109,786
101,311
Total liabilities and stockholders’
equity
$
114,207
$
106,479
APTINYX INC.
CONDENSED STATEMENTS OF
OPERATIONS
(in thousands, except per
share data)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Revenues
Collaboration revenue
$
257
$
936
$
1,564
$
2,751
Operating expenses
Research and development
6,630
11,761
26,049
33,732
General and administrative
5,050
4,523
14,719
14,419
Total operating expenses
11,680
16,284
40,768
48,151
Loss from operations
(11,423
)
(15,348
)
(39,204
)
(45,400
)
Other income
85
558
639
1,768
Net loss and comprehensive loss
$
(11,338
)
$
(14,790
)
$
(38,565
)
$
(43,632
)
Net loss per share - basic and diluted
$
(0.24
)
$
(0.44
)
$
(0.85
)
$
(1.30
)
Weighted average shares outstanding -
basic and diluted
46,978
33,646
45,503
33,510
Source: Aptinyx Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201112005997/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
Aptinyx (NASDAQ:APTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aptinyx (NASDAQ:APTX)
Historical Stock Chart
From Sep 2023 to Sep 2024