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Four Phase 2 studies expected to be ongoing by year end; multiple data read-outs anticipated in 2019 and 2020
Management to host conference call today at 8:00 a.m. ET
EVANSTON, Ill., May 14, 2019 (GLOBE NEWSWIRE) -- 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 first quarter of 2019 and announced recent business highlights.
“So far, 2019 has been marked by the achievement of key milestones and important clinical study results that form the basis for several of our upcoming Phase 2 studies,” said Norbert Riedel, Ph.D., president and chief executive officer at Aptinyx. “In the Phase 2 DPN study of NYX-2925, while the primary endpoint was not met in the total study population, importantly, a post-hoc analysis showed significant analgesic effects in subjects with advanced DPN and identified a most appropriate dose level to take forward. This information will be used for a second Phase 2 study in DPN, which we intend to initiate during the second half of the year alongside a Phase 2 study of NYX-2925 we plan to initiate in fibromyalgia. Additionally, we initiated a Phase 2 study of NYX-783 in post-traumatic stress disorder (PTSD) and expect top-line data to be available in the first half of 2020. Further, we reported highly encouraging data from a non-human primate study of NYX-458, in development as a treatment for cognitive impairment associated with Parkinson’s disease, showing its ability to reverse cognitive deficits. We also observed a favorable safety, tolerability, and pharmacokinetic profile with NYX-458 in our healthy volunteer Phase 1 study. These accomplishments, combined with our healthy balance sheet, support the four Phase 2 studies across our three clinical programs expected to be ongoing by the end of 2019, setting the stage for a series of potentially catalytic data read-outs within the next 24 months.”
First Quarter 2019 and Recent Clinical Program Highlights
Recent Operational Highlight:
Expected Near-Term Milestones
First Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were $136.6 million at March 31, 2019 compared to $150.6 million at December 31, 2018.
Collaboration and Grant Revenue: Revenue was $0.9 million for the first quarter of 2019 compared to $2.5 million for same period in 2018. Aptinyx’s revenue was primarily derived from its research collaboration agreement with Allergan and government grants. The decrease was primarily driven by the completion of work related to all outstanding grants in the first half of 2018. The company does not rely on these revenues to fund its operations.
Research and Development (R&D) Expenses: R&D expenses were $12.5 million for the first quarter of 2019 as compared to $12.2 million for the same period in 2018. The increase in R&D expenses was primarily driven by support of the company’s ongoing development of NYX-2925, NYX-783, and NYX-458.
General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the first quarter of 2019 as compared to $2.0 million for the same period in 2018. The increase in G&A expenses was primarily driven by increased costs related to employee compensation, patent-related matters, and professional fees to support ongoing business operations and compliance with obligations associated with being a publicly traded company.
Net Loss: For the first quarter of 2019, net loss was $16.7 million compared to a net loss of $11.7 million for the first quarter 2018.
The Aptinyx management team will host a conference call and webcast today at 8:00 a.m. ET to review its financial results for the first quarter of 2019 and provide a corporate update. To access the call please dial 1-866-930-5579 (domestic) or 1-409-216-0606 (international) and refer to conference ID 8758664. 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.
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.
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 the company’s product candidates, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, the timing for the company’s receipt of data from its clinical studies, expectations regarding its preclinical development activities, and expectations regarding its uses and sufficiency of capital. Risks that contribute to the uncertain nature of the forward-looking statements include: 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, and other financial results; the company’s ability to fund operations through 2020; 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, 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.
CONDENSED BALANCE SHEETS
|Assets||March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||136,580||$||150,637|
|Prepaid expenses and other current assets||1,518||1,784|
|Total current assets||138,765||153,251|
|Property and equipment and other long-term assets||2,228||2,363|
|Liabilities and stockholders’ equity (deficit)|
|Accrued expenses and other current liabilities||4,586||3,996|
|Total current liabilities||5,923||5,885|
|Other long-term liabilities||384||418|
|Stockholders’ equity (deficit)||134,686||149,311|
|Total liabilities and stockholders’ equity (deficit)||$||140,993||$||155,614|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|Three Months Ended |
|Research and development||12,490||12,224|
|General and administrative||5,725||2,049|
|Total operating expenses||18,215||14,273|
|Loss from operations||(17,325||)||(11,809||)|
|Net loss and comprehensive loss||$||(16,711||)||$||(11,672||)|
|Net loss per share - basic and diluted||$||(0.50||)||$||(2.17||)|
|Weighted average shares outstanding - basic and diluted||33,390||5,378|
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