We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aptinyx Inc | NASDAQ:APTX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.061 | 0.0811 | 0.0849 | 0 | 01:00:00 |
Phase 2 studies in fibromyalgia and painful DPN enrolling as planned – data readouts expected in 1H 2022
Phase 2 study in cognitive impairment expected to recommence imminently – data readout expected in 2H 2022
Reported data from Phase 2 exploratory study of NYX-783 in PTSD, supporting further clinical development – meeting with FDA to discuss future development path April 29, 2021
Strong cash position expected to support operations through multiple clinical data readouts and into 2023
Conference call today at 5:00 p.m. EST
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 2020 and provided updates across the company’s pipeline of novel NMDA receptor modulators.
“Despite the COVID-19 pandemic, we are excited to be advancing clinical development across all four of our pipeline programs,” said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. “The recent and upcoming recommencements of key clinical studies are a testament to the dedication of our team at Aptinyx, and I am grateful to all of my colleagues who have been instrumental in these efforts.”
Dr. Riedel continued, “2020 was a very important year in further validating the novel mechanism through which our NMDA receptor modulators act. The results from our completed PTSD study enhance our understanding of the neurobiology of PTSD and the potential for NYX-783 to be a significant advancement in the field. We have observed the therapeutically relevant activity of our compounds across numerous studies, both in patients and in healthy volunteers. We believe the foundational data we have collected across our pipeline thus far have informed and de-risked the multiple Phase 2 studies that we expect to readout in the next 12-24 months. All of this progress sets us up nicely to bring much needed therapeutic innovation to multiple challenging CNS disorders in the years to come. And, with these important clinical milestones ahead, we are pleased to be in a strong financial position, with a cash balance that we anticipate will support our planned operations into 2023.”
Pipeline Updates
Chronic Pain Pipeline – 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 in three Phase 1 studies in healthy volunteers and two completed Phase 2 studies in patients with chronic pain. Across all studies, NYX-2925 has been well tolerated with no drug-related serious adverse events reported.
Psychiatry Pipeline – NYX-783
Aptinyx is developing NYX-783 for the treatment of PTSD. Across the completed Phase 1 and Phase 2 studies, including more than 200 human subjects combined, NYX-783 was well tolerated with no drug-related serious adverse events reported.
Neurology Pipeline – NYX-458
Aptinyx is developing NYX-458 for the treatment of cognitive impairment. In a Phase 1 study conducted in 62 healthy volunteers, NYX-458 exhibited a favorable pharmacokinetic profile and was well tolerated with no drug-related serious adverse events reported.
Corporate Updates
Upcoming Milestones
Fourth Quarter and Full Year 2020 Financial Results
Cash Position: Cash and cash equivalents were $141.0 million at December 31, 2020, compared to $98.8 million at December 31, 2019.
Collaboration Revenue: Revenue was $0.0 million and $1.6 million for the fourth quarter and full year 2020, respectively, as compared to $1.0 million and $3.7 million for same periods in 2019. Aptinyx’s revenue was derived from its research collaboration agreement with Allergan, now a wholly owned subsidiary of AbbVie, which came to its contractual conclusion during the third quarter of 2020.
Research and Development (R&D) Expenses: R&D expenses were $6.8 million and $32.8 million for the fourth quarter and full year 2020, respectively, as compared to $10.6 million and $44.3 million for same periods in 2019. The decrease in R&D expenses during 2020 was primarily driven by reduced costs associated with the temporary suspension of enrollment across three Phase 2 clinical studies.
General and Administrative (G&A) Expenses: G&A expenses were $4.8 million and $19.5 million for the fourth quarter and full year 2020, respectively, as compared to $4.5 million and $19.0 million for the same periods in 2019.
Net Loss: Net loss was $11.5 million for the fourth quarter of 2020 compared to a net loss of $13.8 million for the same period in 2019. For the year ended December 31, 2020, net loss was $50.1 million, or basic and diluted net loss per share attributable to common stockholders of $1.02, compared to a net loss of $57.4 million, or basic and diluted net loss per share attributable to common stockholders of $1.71, for the year ended December 31, 2019.
Conference Call
The 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 2020 and to provide other business updates. To access the live conference call, please dial (833) 772-0394 (domestic) or (236) 738-2205 (international) and refer to conference ID 4846816. A live audio webcast of the event will be available on the Investors & Media section of Aptinyx’s website at https://ir.aptinyx.com. A replay of the webcast will be archived on Aptinyx’s website for 30 days following the event.
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 are believed to 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.
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 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, expenses, future accumulated deficit and other fourth quarter and year end 2020 financial results, 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 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 approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time‑consuming, and inherently unpredictable; 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 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, 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
December 31, 2020
December 31, 2019
Current Assets:
Cash and cash equivalents
$
141,028
$
98,849
Restricted cash
179
179
Accounts receivable
257
444
Prepaid expenses and other current assets
8,140
5,637
Total current assets
149,604
105,109
Property and equipment and other long-term assets
1,002
1,370
Total assets
$
150,606
$
106,479
Liabilities and stockholders’ equity
Current Liabilities:
Accounts payable
$
1,209
$
1,555
Accrued expenses and other current liabilities
3,374
3,341
Total current liabilities
4,583
4,896
Other long-term liabilities
114
272
Total liabilities
4,697
5,168
Stockholders’ equity
145,909
101,311
Total liabilities and stockholders’ equity
$
150,606
$
106,479
APTINYX INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
Three Months Ended December 31,
Year Ended December 31,
2020
2019
2020
2019
Revenues
Collaboration revenue
$
—
$
918
$
1,564
$
3,669
Operating expenses
Research and development
6,786
10,598
32,835
44,330
General and administrative
4,775
4,533
19,494
18,952
Total operating expenses
11,561
15,131
52,329
63,282
Loss from operations
(11,561
)
(14,213
)
(50,765
)
(59,613
)
Other income
73
435
712
2,203
Net loss and comprehensive loss
$
(11,488
)
$
(13,778
)
$
(50,053
)
$
(57,410
)
Net loss per share - basic and diluted
$
(0.20
)
$
(0.41
)
$
(1.02
)
$
(1.71
)
Weighted average shares outstanding - basic and diluted
58,882
33,692
48,866
33,556
Source: Aptinyx Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005911/en/
Investor and Media Contact: Nick Smith Aptinyx Inc. ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
1 Year Aptinyx Chart |
1 Month Aptinyx Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions