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 fourth quarter and full year 2019 and provided
updates across the company’s pipeline of novel NMDA receptor
modulators. Aptinyx has three distinct product candidates in Phase
2 clinical development across three primary therapeutic areas:
chronic pain, post-traumatic stress disorder (PTSD), and cognitive
impairment.
“We made great progress in 2019 across our programs in chronic
pain, PTSD, and cognitive impairment, highlighted by the initiation
of four Phase 2 studies and positive clinical read-outs on NYX-2925
and NYX-458,” said Norbert Riedel, Ph.D., president and chief
executive officer of Aptinyx. “Like other life sciences companies,
we have had to assess the impact of the evolving COVID-19 pandemic
on the enrollment and conduct of our ongoing Phase 2 studies. The
health and safety of the patients, clinicians, and colleagues
involved in our studies are of the utmost importance to Aptinyx.
Under these unprecedented circumstances, we are taking actions to
address and react to operational challenges and reduce the risk of
viral infection. We are fortunate to have a strong balance sheet
and we currently expect our cash on hand, including the
approximately $33 million in net proceeds from our January
financing, to support our operations into 2022.”
Actions Taken on Ongoing Clinical Studies Due to
COVID-19 Pandemic
The company has worked closely with the clinicians and study
personnel involved in each of its ongoing studies to evaluate the
impacts of the COVID-19 pandemic and identify the most appropriate
measures to ensure patient safety and data integrity.
- NYX-783 exploratory Phase 2 study in PTSD.
This study is approximately 80% enrolled to date. At present,
Aptinyx has been able to mitigate and manage the impacts of
COVID-19 on the study through measures such as home delivery of
study drug and virtual participant follow-up. While monitoring the
impacts of COVID-19 continuously, the company intends to continue
enrollment of patients as long as it is responsible and practical
to do so. Aptinyx anticipates providing updated guidance on the
expected timing of study completion and reporting of data at a
future date.
- NYX-2925 Phase 2b studies in painful diabetic
peripheral neuropathy (DPN) and fibromyalgia. On March 27,
2020, Aptinyx temporarily suspended enrollment of new patients in
these studies. Aptinyx has instituted certain measures to support
the continuity of patients currently enrolled, but the challenges
posed by the COVID-19 pandemic to patient recruitment, screening,
and randomization limit the feasibility of enrolling new patients
at the present time. Aptinyx anticipates updating guidance around
the expected timing of reporting top-line data from these studies
at a future date following the recommencement of
enrollment.
- NYX-458 exploratory Phase 2 study in Parkinson’s
disease cognitive impairment. On March 27, 2020, Aptinyx
temporarily suspended enrollment of new patients in this study. The
elevated risk of the COVID-19 pandemic to the relatively elderly
patient population in this study, as well as the challenges of
administering cognitive assessments remotely, limit the feasibility
of enrolling new patients in this study at the present time.
Aptinyx anticipates updating guidance around the expected timing of
reporting data from this study at a future date following the
recommencement of enrollment.
Pipeline and Corporate Updates
Chronic Pain Franchise – NYX-2925:Aptinyx is
developing NYX-2925 for the treatment of chronic centralized pain
conditions. To date, NYX-2925 has been studied in more than 400
human subjects, including three Phase 1 studies in healthy
volunteers and two completed Phase 2 studies in patients with
chronic pain. Across all of these studies, NYX-2925 has been well
tolerated with no drug-related serious adverse events reported.
• Development in painful DPN: In January 2019,
Aptinyx reported results from a 300-patient Phase 2 study in
patients with painful DPN.
- Results:• On the primary endpoint, change in average daily
pain score at week four, statistically significant separation from
placebo was not observed for the total study population (N=300);
however, a clinically meaningful reduction in pain scores from
baseline was observed with a numeric separation from
placebo.• In a pre-specified analysis, patients not taking a
concomitant analgesic (N=147) showed even greater separation from
placebo at week 4 compared to the overall population.• A
retrospective analysis demonstrated that, consistent with the
mechanism of NYX-2925 targeting the centralized pain processing
that manifests over time, as duration of DPN increased, a greater
benefit with NYX-2925 was observed. In advanced DPN
patients—patients with DPN for four years or longer
(N=127)—NYX-2925 demonstrated clinically meaningful and
statistically significant separation from placebo on the change in
average daily pain score and other patient-reported
symptoms.• The 50 mg dose demonstrated the largest and most
consistent separation from placebo within the study.• Aptinyx
presented the detailed findings from this study at the American
Pain Society Annual Meeting in April 2019.
- Next steps:• The signal observed in the first Phase 2
study informed Aptinyx’s initiation of a follow-up Phase 2b study
in patients with painful DPN. This study is a randomized,
double-blind, parallel-design, placebo-controlled study to evaluate
daily oral dosing of 50 mg of NYX-2925 compared to placebo in
approximately 200 patients with advanced DPN. The primary endpoint
is the change in average daily pain score over a 12-week period as
reported on the 10-point numeric rating scale (NRS).• Due to
screening and enrollment challenges introduced by the COVID-19
pandemic, on March 27, 2020, Aptinyx temporarily suspended
enrollment of new patients in this Phase 2b study. Patients already
enrolled may continue in the study as per protocol and based on
medical guidance.• Aptinyx anticipates updating guidance
around the expected timing of reporting top-line data from this
Phase 2b study at a future date following the recommencement of
enrollment.
• Development in fibromyalgia: In June
2019, Aptinyx reported results from a 22-patient Phase 2
neuroimaging biomarker study in patients with fibromyalgia.
- Results:• NYX-2925 met the primary endpoint in the study,
exhibiting statistically significant effects on validated
neuroimaging biomarkers in certain pre-specified brain regions
known to be involved in centralized pain processing.• NYX-2925
also demonstrated corresponding statistically significant
improvements on key secondary endpoints—measures of
patient-reported symptoms, including pain scores, overall
fibromyalgia impact, and fatigue.• The results from this study
were presented at the American College of Rheumatology Annual
Meeting in November 2019 as a late-breaking presentation.
- Next steps:• Based on the positive results and activity
observed in the initial Phase 2 biomarker study, Aptinyx initiated
a follow-up Phase 2b study in patients with fibromyalgia. The study
is a randomized, double-blind, parallel-design, placebo-controlled
study to evaluate daily oral dosing of two dose levels of NYX-2925
(50 mg and 100 mg) compared to placebo in approximately 300
patients with fibromyalgia. The primary endpoint is the change in
average daily pain score over a 12-week period as reported on the
10-point NRS.• Due to screening and enrollment challenges
introduced by the COVID-19 pandemic, on March 27, 2020, Aptinyx
temporarily suspended enrollment of new patients in this study.
Patients already enrolled in the Phase 2 study may continue in the
study as per protocol and based on medical guidance.
• Aptinyx anticipates updating guidance around the
expected timing of reporting top-line data from this Phase 2b study
at a future date following the recommencement of enrollment.
Psychiatry Franchise – NYX-783:Aptinyx is
developing NYX-783 for the treatment of post-traumatic stress
disorder. In a Phase 1 study conducted in healthy volunteers,
NYX-783 was well tolerated with no drug-related serious adverse
events reported.
• Development in post-traumatic stress disorder
(PTSD): In February 2019, Aptinyx initiated a
first-in-patient Phase 2 exploratory study of NYX-783 in patients
with PTSD.
- Phase 2 study:• The study is a double-blind,
placebo-controlled, sequential parallel comparison design (SPCD)
study in approximately 150 patients with PTSD. The study consists
of two four-week stages in which patients are randomly assigned to
receive once-daily doses of either placebo, 10 mg of NYX-783, or 50
mg NYX-783.• This first Phase 2 study in PTSD patients
evaluates whether NYX-783 exhibits a signal of efficacy on the
CAPS-5 composite endpoint of PTSD symptoms as well as its
sub-scores.• Multiple other efficacy endpoints are under
evaluation in the study to assess the impact of NYX-783 across a
spectrum of PTSD symptoms.
- Next steps:• Aptinyx is currently enrolling patients in
this Phase 2 exploratory study and approximately 80% of the target
enrollment has been achieved to date.• The COVID-19 pandemic
has resulted in some disruptions at the site level in this Phase 2
study, which Aptinyx has been able to mitigate and manage to date.
Notwithstanding, Aptinyx is actively and continuously monitoring
any further impacts the COVID-19 pandemic may have on this study
and anticipates providing updated guidance on the expected timing
of its completion and reporting of data at a future date.
Neurology Franchise – NYX-458:Aptinyx is
developing NYX-458 for the treatment of cognitive impairment
associated with Parkinson’s disease. In a Phase 1 study conducted
in healthy volunteers, NYX-458 was well tolerated with no
drug-related serious adverse events reported.
• Development in Parkinson’s disease cognitive
impairment: In December 2019, based on
compelling preclinical data including those from a highly
translatable model in non-human primates, Aptinyx initiated a
first-in-patient Phase 2 exploratory study of NYX-458 in patients
with mild cognitive impairment associated with Parkinson’s disease
(Parkinson’s MCI).
- Phase 2 study:• The Phase 2 study is a randomized,
double-blind, parallel-design, placebo-controlled study to evaluate
the safety and potential cognitive benefits of daily oral dosing of
three dose levels of NYX-458 (10 mg, 30 mg, and 100 mg) compared to
placebo in approximately 135 patients with Parkinson’s MCI over a
12-week period.• This exploratory study evaluates the safety
of NYX-458 in patients with Parkinson’s MCI, as well as its effects
on cognitive performance using multiple measures across various
cognitive domains.
- Next steps:• Due to clinical study conduct challenges
introduced by the COVID-19 pandemic, on March 27, 2020, Aptinyx
temporarily suspended enrollment of new patients in this study.
Patients already enrolled in the Phase 2 study may continue in the
study as per protocol and based on medical guidance.• Aptinyx
anticipates updating guidance around the expected timing of
reporting data from this Phase 2 exploratory study at a future date
following the recommencement of enrollment.
• Publication of data in Movement Disorders
demonstrating reversal of cognitive deficits with NYX-458 in
primate model of Parkinson’s disease. In January 2020,
Aptinyx announced a publication in Movement
Disorders highlighting the results of a preclinical study of
NYX-458 in a validated and translatable model of Parkinson’s
disease in non-human primates. In the study, administration of
NYX-458 resulted in a robust and enduring reversal of MPTP-induced
cognitive deficits. The data were published in the January 2020
issue of Movement Disorders, the official journal of
the International Parkinson and Movement Disorder
Society.
Corporate Updates:
• Strengthened the company’s financial position
through the completion of a $35 million common stock
offering. In early January 2020, Aptinyx announced the
closing of a public offering of common stock with gross proceeds
totaling $35.1 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 offering included participation from new and existing
investors. The company’s current cash balance, inclusive of the
proceeds from the offering, is expected to provide financial
support into 2022.
• Key strategic and regulatory expertise added to
Aptinyx’s Board of Directors. In 2019, Aptinyx appointed
two new members to its Board of Directors. Henry Gosebruch, chief
strategy officer at AbbVie and former co-head of J.P. Morgan’s
North American M&A group, joined the company’s Board in May
2019. Additionally, Rachel Sherman, M.D., M.P.H., former principal
deputy commissioner of the U.S. Food and Drug Administration (FDA),
joined the company’s Board in September 2019.
Fourth Quarter and Full Year 2019 Financial
Results
Cash Position: Cash and cash equivalents were
$98.8 million at December 31, 2019, compared to $150.6 million at
December 31, 2018. Subsequently, Aptinyx completed a follow-on
public offering of common stock in January 2020 with net proceeds
of approximately $33.3 million.
Collaboration and Grant Revenue: Revenue was
$0.9 million and $3.7 million for the fourth quarter
and full year 2019, respectively, as compared to $1.0 million and
$6.6 million for same periods in 2018. Aptinyx’s revenue was
primarily derived from its research collaboration agreement with
Allergan. The company does not rely on these revenues to fund its
operations. The decrease in collaboration and grant revenue
compared to 2018 was primarily driven by the receipt of a $1.0
million option exercise fee from Allergan in 2018, as well as the
completion of grant-related activities in 2018.
Research and Development (R&D)
Expenses: R&D expenses were $10.6
million and $44.3 million for the fourth quarter and
full year 2019, respectively, as compared to $10.9 million and
$48.8 million for same periods in 2018. The decrease in R&D
expenses during 2019 was primarily driven by a reduction in product
and clinical development spend related to NYX-2925 and a decrease
in costs associated with our preclinical research efforts with
external research organizations.
General and Administrative (G&A)
Expenses: G&A expenses were $4.5
million and $19.0 million for the fourth quarter and
full year 2019, respectively, as compared to $4.8 million and $12.7
million for the same periods in 2018. The increase in G&A
expenses was primarily driven by increased costs related to
employee compensation, including a $4.1 million increase in
non-cash stock-compensation expense for the full year 2019,
increased professional fees and insurance costs to support ongoing
business operations, and patent-related costs associated with
developing a robust patent estate covering the company’s novel
product candidates.
Net Loss: Net loss was $13.8 million for the
fourth quarter of 2019 compared to a net loss of $14.1 million for
the same period in 2018. For the year ended December 31, 2019,
net loss was $57.4 million, or basic and diluted net loss per
share attributable to common stockholders of $1.71, compared
to a net loss $53.3 million, or basic and diluted net loss per
share attributable to common stockholders of $2.64, for the
year ended December 31, 2018.
Financial Guidance: Aptinyx expects that
current cash, inclusive of the $33.3 million in net proceeds from
the common stock offering in January 2020, will be sufficient to
fund the company’s planned operations into 2022.
Conference CallThe Aptinyx management team will
host a conference call and webcast today at 5:00 p.m. EDT to review
its financial results and highlights for the full year 2019 and to
provide other business updates. To access the call, please dial
1-866-930-5579 (domestic) or 1-409-216-0606 (international) and
refer to conference ID 3837499. 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 AptinyxAptinyx 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 StatementsStatements 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 providing updated guidance with
respect thereto, 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
COVID-19 on the foregoing. Risks that contribute to the uncertain
nature of the forward-looking statements include: the effect of
COVID-19 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 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 through 2021; 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,
2019. 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 |
December 31, 2019 |
|
December 31, 2018 |
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
98,849 |
|
$ |
150,637 |
Restricted cash |
179 |
|
252 |
Accounts receivable |
444 |
|
578 |
Prepaid expenses and other current assets |
5,637 |
|
1,784 |
Total current assets |
105,109 |
|
153,251 |
Property and equipment and
other long-term assets |
1,370 |
|
2,363 |
Total assets |
$ |
106,479 |
|
$ |
155,614 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity (deficit) |
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,555 |
|
$ |
1,889 |
Accrued expenses and other current liabilities |
3,341 |
|
3,996 |
Total current liabilities |
4,896 |
|
5,885 |
Other long-term
liabilities |
272 |
|
418 |
Total liabilities |
5,168 |
|
6,303 |
Convertible preferred
stock |
— |
|
— |
Stockholders’ equity
(deficit) |
101,311 |
|
149,311 |
Total liabilities and stockholders’ equity (deficit) |
$ |
106,479 |
|
$ |
155,614 |
|
|
|
|
|
|
|
APTINYX INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(in thousands, except per share data) |
(Unaudited) |
|
|
Three Months EndedDecember 31, |
|
Year Ended December 31, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and grant revenue |
$ |
918 |
|
|
$ |
1,039 |
|
|
$ |
3,669 |
|
|
$ |
6,574 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
10,598 |
|
|
10,928 |
|
|
44,330 |
|
|
48,788 |
|
General and administrative |
4,533 |
|
|
4,822 |
|
|
18,952 |
|
|
12,674 |
|
Total operating expenses |
15,131 |
|
|
15,750 |
|
|
63,282 |
|
|
61,462 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(14,213 |
) |
|
(14,711 |
) |
|
(59,613 |
) |
|
(54,888 |
) |
Other income |
435 |
|
|
618 |
|
|
2,203 |
|
|
1,607 |
|
Net loss and comprehensive loss |
$ |
(13,778 |
) |
|
$ |
(14,093 |
) |
|
$ |
(57,410 |
) |
|
$ |
(53,281 |
) |
Net loss per share - basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.71 |
) |
|
$ |
(2.64 |
) |
Weighted average shares outstanding - basic and diluted |
33,692 |
|
|
33,286 |
|
|
33,556 |
|
|
20,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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