SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Act of 1934
Date of Report (Date of earliest event reported): May 14, 2020
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
|(Commission File Number)||(I.R.S. Employer Identification|
|909 Davis Street, Suite 600
|(Address of principal executive offices)||(Zip Code)|
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.01 per share||APTX||The Nasdaq Global Select Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
|Item 2.02.||Results of Operations and Financial Condition.|
On May 14, 2020, Aptinyx Inc. issued a press release announcing its financial results for the quarter ended March 31, 2020. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press release issued by Aptinyx Inc. on May 14, 2020, furnished herewith|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: May 14, 2020||By:||/s/ Ashish Khanna|
|Chief Financial Officer and Chief Business Officer|
Aptinyx Reports First Quarter 2020 Financial Results and Highlights
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 $121 million expected to support planned operations into 2022
Conference call today at 5:00 p.m. EDT
EVANSTON, Ill., May 14, 2020 -- 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 2020 and highlighted recent progress across the company’s clinical programs and pipeline of novel NMDA receptor modulators.
“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 Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “Despite challenges introduced by the pandemic across our operations, we made great progress in the first quarter and subsequent period and I am very proud of the dedication and adaptability of our team. Thanks to those efforts, enrollment in our PTSD study has progressed exceedingly well and we expect to report data from that study late this year. With our strong balance sheet, we expect to be able to achieve additional important clinical data readouts across our pipeline of novel NMDA receptor modulators as well.”
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, Aptinyx announced 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, Aptinyx anticipates 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, Aptinyx announced 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. Aptinyx anticipates 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 million common stock offering. In 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 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, Aptinyx announced 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.|
Aptinyx anticipates providing updated guidance on the timing of data reporting for the following clinical studies at a future date:
|·||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 $121.0 million at March 31, 2020 compared to $98.8 million at December 31, 2019. Aptinyx expects its current cash balance to support anticipated operations into 2022.
Collaboration Revenue: Revenue was $0.8 million for the first quarter of 2020 compared to $0.9 million for same period in 2019. Aptinyx’s revenue was derived from its research collaboration agreement with Allergan. The company does not rely on these revenues to fund its operations.
Research and Development (R&D) Expenses: R&D expenses were $11.1 million for the first quarter of 2020 as compared to $12.5 million for the same period in 2019. The decrease in R&D expenses was primarily driven by a reduction in employee compensation, partially offset by increased costs related to the initiation of the company’s two Phase 2b studies of NYX-2925 in chronic pain.
General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the first quarter of 2020 as compared to $5.7 million for the same period in 2019. The decrease of $0.8 million was primarily driven by a decrease in legal costs associated with patent-related matters.
Net Loss: For the first quarter of 2020, net loss was $14.7 million compared to a net loss of $16.7 million for the first quarter 2019.
The Aptinyx management team will host a conference call and webcast today at 5:00 p.m. EST to review its financial results and highlights for the first quarter of 2020 and subsequent period. To access the call, please dial 1-866-930-5579 (domestic) or 1-409-216-0606 (international) and refer to conference ID 2094044. 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, 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
|March 31, 2020||December 31, 2019|
|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|
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Source: Aptinyx Inc.