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Completed Phase 2 study of NYX-2925 in painful DPN -- did not meet primary endpoint, but NYX-2925 demonstrated robust analgesic activity in a large and mechanistically relevant patient sub-group
Reported positive data from interim analysis of Phase 2 exploratory neuroimaging study of NYX-2925 in patients with fibromyalgia -- study completion and data expected in 1H 2019
Confirmed novel NMDAr modulatory mechanism in humans through EEG studies in healthy volunteers
Initiated first-in-patient Phase 2a study of NYX-783 in patients with PTSD -- data expected in 1H 2020
Nearing completion of Phase 1 study of NYX-458 in healthy volunteers -- data expected in 1H 2019
Conference call today at 8:00 a.m. ET
EVANSTON, Ill., March 21, 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 fourth quarter and full year 2018 and announced recent business highlights.
“This past year was marked by a number of important clinical and preclinical study results showing activity and safety of the product candidates in our pipeline, informing our ongoing development of innovative therapies for CNS disorders that are vastly underserved by the treatments available today,” said Norbert Riedel, Ph.D., president and chief executive officer at Aptinyx. “We learned that NYX-2925 is active in the human brain in a manner that is highly relevant in pain processing, that it has excellent safety in both healthy volunteers and chronic pain patients, and that the rich dataset from our study in DPN informs future development. While that DPN study missed the primary endpoint, we saw that patients with advanced DPN experienced a significant reduction in their pain with NYX-2925. NYX-783 also exhibited a very favorable safety and tolerability profile in healthy volunteers, allowing for our recent initiation of a Phase 2a study in patients with PTSD. And NYX-458 demonstrated highly compelling effects on cognitive impairment in a non-human primate model of Parkinson’s disease. Our strong balance sheet and the extensive learnings garnered over the past year enable us to continue advancing all of our innovative product candidates, which have the potential to positively impact the lives of patients suffering from difficult CNS disorders.”
Fourth Quarter 2018 and Recent Highlights
Fourth Quarter and Full Year 2018 Financial Results
Cash Position: Cash and cash equivalents were $150.6 million at December 31, 2018 compared to $92.1 million at December 31, 2017.
Collaboration and Grant Revenue: Revenue was $1.0 million and $6.6 million for the fourth quarter and full year 2018, respectively, as compared to $1.2 million and $5.0 million for the same periods in 2017. Aptinyx’s revenue was primarily derived from its research collaboration agreement with Allergan and government grants. The increase was primarily driven by Allergan’s payment of a $1.0 million fee in conjunction with its May 2018 exercise of its option to acquire exclusive rights to develop and commercialize AGN-241751, a product candidate from Aptinyx’s novel chemistry platform, pursuant to the research collaboration agreement.
Research and Development (R&D) Expenses: R&D expenses were $10.9 million and $48.8 million for the fourth quarter and full year 2018, respectively, as compared to $6.7 million and $31.6 million for the same periods in 2017. The increase in R&D expenses was primarily driven by support of the company’s Phase 2 clinical studies of NYX-2925 in painful DPN and fibromyalgia, Phase 1 clinical study costs related to ongoing development of NYX-458 for the treatment of Parkinson’s disease cognitive impairment, ongoing development of NYX-783 for the treatment of PTSD and costs related to employee compensation due to increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $4.8 million and $12.7 million for the fourth quarter and full year 2018, respectively, as compared to $1.7 million and $5.6 million for the same periods in 2017. The increase in G&A expenses was primarily driven by increased costs related to employee compensation and professional fees to support ongoing business operations and compliance with obligations associated with being a publicly traded company.
Net Loss: For the fourth quarter of 2018, net loss was $14.1 million, or basic and diluted net loss per share attributable to common stockholders of $0.42, compared to a net loss of $7.2 million, or basic and diluted net loss per share attributable to common stockholders of $1.36, for the fourth quarter 2017. For the year ended December 31, 2018, net loss was $53.3 million, or basic and diluted net loss per share attributable to common stockholders of $2.64, compared to a net loss $32.1 million, or basic and diluted net loss per share attributable to common stockholders of $6.17, for the year ended December 31, 2017.
The Aptinyx management team will host a conference call and webcast today at 8:00am ET to provide a corporate update and financial results for the fourth quarter and full year 2018, followed by a Q&A session. To access the call please dial 1-866-930-5579 (domestic) or 1-409-216-0606 (international) and refer to conference ID 5973525. 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 NYX-2925, 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 2018 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 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, 2018. 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||December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||150,637||$||92,136|
|Prepaid expenses and other current assets||1,784||1,960|
|Total current assets||153,251||95,033|
|Property and equipment and other long-term assets||2,363||2,289|
|Liabilities and stockholders’ equity (deficit)|
|Accrued expenses and other current liabilities||3,996||2,835|
|Total current liabilities||5,885||4,372|
|Other long-term liabilities||418||282|
|Convertible preferred stock||—||132,386|
|Stockholders’ equity (deficit)||149,311||(39,718||)|
|Total liabilities and stockholders’ equity (deficit)||$||155,614||$||97,322|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended
|Collaboration and grant revenue||$||1,039||$||1,185||$||6,574||$||4,962|
|Research and development||10,928||6,714||48,788||31,644|
|General and administrative||4,822||1,733||12,674||5,551|
|Total operating expenses||15,750||8,447||61,462||37,195|
|Loss from operations||(14,711||)||(7,262||)||(54,888||)||(32,233||)|
|Net loss and comprehensive loss||$||(14,093||)||$||(7,227||)||$||(53,281||)||$||(32,068||)|
|Net loss per share - basic and diluted||$||(0.42||)||$||(1.36||)||$||(2.64||)||$||(6.17||)|
|Weighted average shares outstanding - basic and diluted||33,286||5,305||20,199||5,196|
Stern Investor Relations, Inc.
Source: Aptinyx Inc.