Over 90% of target enrollment achieved to date in Phase 2 exploratory study of NYX-783 in PTSD; data readout expected in late 2020
Cash balance of
Conference call today at
“In the midst of the COVID-19 global pandemic, the safety of our employees, colleagues, and patients participating in our clinical studies remains our top priority,” said
First Quarter 2020 and Recent Highlights
- Achieved over 90% of target patient enrollment to date in Phase 2 exploratory study of NYX-783 in post-traumatic stress disorder (PTSD). In March,
Aptinyxannounced that enrollment of new patients in its exploratory Phase 2 study of NYX-783 in PTSD was continuing despite some disruptions introduced by the COVID-19 pandemic. In the weeks since, enrollment has continued to progress and, to date, over 90% of the target enrollment has been achieved. Following study completion, Aptinyxanticipates reporting data from this study late in 2020.
- Temporarily paused enrollment of new patients in three ongoing Phase 2 studies due to COVID-19. In March,
Aptinyxannounced the temporary suspension of new patient enrollment in its Phase 2 studies in painful diabetic peripheral neuropathy (DPN), fibromyalgia, and Parkinson’s disease cognitive impairment. Aptinyxanticipates providing updated guidance on the expected timing of study completion and data reporting for these studies in the future following the recommencement of enrollment.
- Strengthened financial position through the completion of a
$35 millioncommon stock offering. In January 2020, Aptinyxannounced 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 is expected to provide financial support into 2022.
- Published preclinical data in Movement Disorders journal demonstrating reversal of cognitive deficits with NYX-458 in primate model of Parkinson’s disease. In
January 2020, Aptinyxannounced a publication in Movement Disorders, the official journal of the International Parkinson and Movement Disorder Society, 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 in primates.
- Reporting data from Phase 2 exploratory, first-in-patient study of NYX-783 in patients with PTSD – late 2020.
- Phase 2 study of NYX-2925 in painful DPN.
- Phase 2 study of NYX-2925 in fibromyalgia.
- Phase 2 exploratory study of NYX-458 in Parkinson’s disease cognitive impairment.
First Quarter 2020 Financial Results
Cash Position: Cash and cash equivalents were
Collaboration Revenue: Revenue was
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: For the first quarter of 2020, net loss was
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 the effects of the COVID-19 pandemic on patient enrollment and the expected timing of study completion, data reporting, and 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 into 2022; 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, 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.
|CONDENSED BALANCE SHEETS|
|Cash and cash equivalents||$||121,020||$||98,849|
|Prepaid expenses and other current assets||4,114||5,637|
|Total current assets||126,131||105,109|
|Property and equipment, net and other long-term assets||1,267||1,370|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||2,796||3,341|
|Total current liabilities||4,646||4,896|
|Other long-term liabilities||234||272|
|Total liabilities and stockholders’ equity||$||127,398||$||106,479|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended
|Research and development||11,055||12,490|
|General and administrative||4,899||5,725|
|Total operating expenses||15,954||18,215|
|Loss from operations||(15,136||)||(17,325||)|
|Net loss and comprehensive loss||$||(14,710||)||$||(16,711||)|
|Net loss per share - basic and diluted||$||(0.34||)||$||(0.50||)|
|Weighted average shares outstanding - basic and diluted||43,835||33,390|
Source: Aptinyx Inc.