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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): March 30, 2023

 

 

 

APTINYX INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38535   47-4626057

(State or other jurisdiction

of incorporation)

 

 

(Commission

File Number)

 

 

(I.R.S. Employer

Identification No.)

 

909 Davis Street, Suite 600

EvanstonIL 60201

(Address of principal executive offices, including zip code)

 

(847) 871-0377

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

 

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 240.13e-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 Capital 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 March 30, 2023, Aptinyx Inc. issued a press release announcing its financial results for the year ended December 31, 2022. 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.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press release issued by Aptinyx Inc. on March 30, 2023, furnished herewith
104  Cover Page Interactive Data (embedded within the Inline XBRL document)

 

 

 

SIGNATURES

 

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.

 

  Aptinyx Inc.
     
Date: March 30, 2023 By:

/s/ Ashish Khanna

   

Ashish Khanna

Chief Financial Officer and Chief Business Officer

 

 

 

 

 

 

 

Exhibit 99.1

 

 

 

Aptinyx Reports on Fourth Quarter and Full Year 2022 Results and Highlights and Review of Strategic Alternatives

 

EVANSTON, Ill., March 30, 2023 -- Aptinyx Inc. (Nasdaq: APTX) today reported recent business updates and financial results for the fourth quarter and full year 2022.

 

Recent Business Updates

 

·In March, Aptinyx completed an analysis of the data from the first 100 patients enrolled in its Phase 2b clinical study of NYX-783 50 mg in patients with post-traumatic stress disorder (PTSD). The study was halted in February prior to its completion in support of the company’s preservation of capital. In the analysis, NYX-783 did not demonstrate sufficient improvement on the study’s primary endpoint to support continued advancement of the development program by Aptinyx.

 

·In March, Aptinyx engaged Ladenburg Thalmann as its exclusive financial advisor to assist in the company’s exploration and evaluation of strategic alternatives.

 

·In March, Aptinyx announced a reduction in its workforce by approximately 60% to reduce the company’s operating costs and better align its workforce with the needs of its business as the company assesses strategic alternatives.

 

·In February, Aptinyx announced results from its Phase 2 clinical study of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. Across the overall study population, NYX-458 did not demonstrate clinically meaningful improvements over placebo on the study’s efficacy endpoints. The results do not support further advancement of the development program by the company.

 

·Aptinyx’s NMDA receptor positive allosteric modulator, NYX-783, is under development as a treatment for opioid use disorder (OUD), supported by a $5.6 million grant issued to researchers at Yale University School of Medicine. The grant was awarded under the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative, administered by the National Institute on Drug Abuse (NIDA), and funds the research and development of NYX-783 for the treatment of OUD. A Phase 1 drug-drug interaction study is ongoing and is being administered by the Yale Interdisciplinary Stress Center through a research collaboration with Aptinyx.

 

Fourth Quarter and Full Year 2022 Financial Results

 

Cash Position: Cash and cash equivalents were $56.2 million at December 31, 2022, compared to $106.1 million at December 31, 2021. The company had $25.0 million of debt principal under a capital credit facility with K2 HealthVentures, which remains currently outstanding. 

 

 

 

Collaboration Revenue: Revenue was $0.0 million for the fourth quarter and full year 2022, as compared to $0.0 million and $1.0 million for same periods in 2021.

 

Research and Development (R&D) Expenses: R&D expenses were $7.2 million and $42.7 million for the fourth quarter and full year 2022, respectively, as compared to $14.1 million and $55.4 million for same periods in 2021. The decrease in R&D expenses during 2022 was primarily driven by decreased costs associated with the close out of clinical development activities across three Phase 2 clinical studies.

 

General and Administrative (G&A) Expenses: G&A expenses were $4.2 million and $19.8 million for the fourth quarter and full year 2022, respectively, as compared to $5.1 million and $20.1 million for the same periods in 2021.

 

Net Loss: Net loss was $12.1 million for the fourth quarter of 2022 compared to a net loss of $19.6 million for the same period in 2021. For the year ended December 31, 2022, net loss was $64.8 million, or basic and diluted net loss per share attributable to common stockholders of $0.96, compared to a net loss of $74.9 million, or basic and diluted net loss per share attributable to common stockholders of $1.11, for the year ended December 31, 2021.

 

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, the company’s ongoing evaluation of strategic alternatives, including future plans or expectations for NYX-783 and NYX-458, the safety, therapeutic effects, and stage of development 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 and expenses, 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 clinical studies; the company’s ability to execute on its strategy; including its ongoing strategic evaluation; the company’s estimates regarding expenses, future revenue, and capital requirements; 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, 2022. Potential strategic alternatives that may be explored or evaluated as part of the company’s ongoing evaluation include the potential for a merger, business combination, investment into the company, asset sale or other strategic transaction. No timetable has been established for the completion of this process, and the we do not expect to disclose developments unless and until the Board of Directors has concluded that disclosure is appropriate or required. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aptinyx disclaims any intention 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)

 

   December 31, 2022   December 31, 2021 
Assets          
Current Assets:          
Cash and cash equivalents  $56,205   $106,124 
Restricted cash   179    197 
Prepaid expenses and other current assets   7,646    8,422 
Total current assets   64,030    114,743 
Property and equipment and other long-term assets   2,654    185 
Total assets  $66,684   $114,928 
           
           
Liabilities and stockholders’ equity          
Current Liabilities:          
Accounts payable  $724   $622 
Accrued expenses and other current liabilities   2,772    5,064 
Term loan, current   2,795    ---- 
Total current liabilities   6,291    5,686 
Other long-term liabilities   22,108    14,486 
Total liabilities   28,399    20,172 
           
Stockholders’ equity   38,285    94,756 
Total liabilities and stockholders’ equity  $66,684   $114,928 

 

 

 

APTINYX INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)

 

   Three Months Ended
December 31,
  

Year Ended

December 31,

 
   2022   2021   2022   2021 
Collaboration revenue  $   $   $   $1,000 
                     
Operating expenses                    
Research and development   7,230    14,056    42,748    55,444 
General and administrative   4,196    5,116    19,819    20,090 
Total operating expenses   11,426    19,172    62,567    75,534 
                     
Loss from operations   (11,426)   (19,172)   (62,567)   (74,534)
Other income (expense)   (627)   (438)   (2,282)   (352)
Net loss and comprehensive loss  $(12,053)  $(19,610)  $(64,849)  $(74,886)
Net loss per share - basic and diluted  $(0.18)  $(0.29)  $(0.96)  $(1.11)
Weighted average shares outstanding - basic and diluted   67,716    67,716    67,716    67,220 

 

Investor & Media Contact:

Patrick Flavin

Aptinyx Inc.

ir@aptinyx.com or corporate@aptinyx.com

847-871-0377

 

 

Source: Aptinyx Inc.