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 Act of 1934

 

Date of Report (Date of earliest event reported): November 12, 2019

 

APTINYX INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-38535

 

45-4626057

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
Number)

 

909 Davis Street, Suite 600
Evanston, IL

 

60201

(Address of principal executive offices)

 

(Zip Code)

 

(847) 871-0377

(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:

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o 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. o

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On November 12, 2019, Aptinyx Inc. issued a press release announcing its financial results for the quarter ended September 30, 2019. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release, dated November 12, 2019

 

2


 

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: November 12, 2019

By:

/s/ Ashish Khanna

 

 

Ashish Khanna

 

 

Chief Financial Officer and Chief Business Officer

 

3


Exhibit 99.1

 

 

Aptinyx Reports Third Quarter 2019 Financial Results and Highlights

 

Initiated two Phase 2 studies of NYX-2925 in chronic pain conditions

 

On track to have four Phase 2 studies ongoing by year end across pipeline of CNS product candidates

 

Conference call today at 5:00 p.m. EST

 

EVANSTON, Ill., November 12, 2019 — 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 third quarter of 2019 and highlighted recent progress across the company’s pipeline of novel NMDA receptor modulators.

 

“We made significant progress in the third quarter and subsequent period, including the initiation of two Phase 2 studies of NYX-2925 in patients with painful DPN and fibromyalgia,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “By the end of the year, we will have four Phase 2 studies ongoing, including the pain studies, our study of NYX-783 in PTSD, and a study of NYX-458 in Parkinson’s cognitive impairment that we will initiate very soon.  We set out to build a transformative neuroscience company, and these pipeline advances are key steps in achieving our goal of bringing novel medicines to patients in need of better therapeutic options.”

 

Third Quarter 2019 and Recent Highlights

 

·                  Initiated a Phase 2 study of NYX-2925 in patients with painful diabetic peripheral neuropathy. Earlier today, Aptinyx announced the initiation of a Phase 2 study evaluating the effects of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN). The study is evaluating daily oral dosing of NYX-2925 50 mg compared to placebo. The primary endpoint is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). The company expects to report top-line results from this study in late 2020 or early 2021.

 

·                  Initiated a Phase 2 study of NYX-2925 in patients with fibromyalgia. Earlier today, Aptinyx announced the initiation of a Phase 2 study evaluating the effects of NYX-2925 in patients with fibromyalgia. The study is evaluating daily oral dosing of two dose levels of NYX-2925—50 mg and 100 mg—compared to placebo. The primary endpoint is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). The company expects to report top-line results from this study in the first half of 2021.

 

·                  Results of a Phase 2 fibromyalgia study of NYX-2925 were selected for a late-breaking presentation at the American College of Rheumatology Annual Meeting (ACR/ARP). In October 2019, Aptinyx announced that data from its Phase 2 neuroimaging study of NYX-2925 in patients with fibromyalgia were selected to be presented in a late-breaking poster presentation at the ACR Annual Meeting. The results of the study show that NYX-2925 had statistically significant effects on neuroimaging biomarkers associated with

 


 

central pain processing and that it significantly improved patient-reported symptoms of fibromyalgia. The ePoster was presented today, November 12, 2019 in Atlanta, Georgia.

 

·                  Presented preclinical data on all three clinical-stage product candidates at the 49th Annual Meeting of the Society for Neuroscience. In October 2019, Aptinyx announced six presentations at the 49th Annual Meeting of the Society for Neuroscience. The presentations exhibited preclinical data supporting the development of each of the company’s three novel NMDA receptor modulators, NYX-2925, NYX-783, and NYX-458, in chronic pain, PTSD, and cognitive impairment, respectively.

 

·                  Three preclinical publications highlighted NMDA receptor activation facilitated by NYX-2925. In September 2019, Aptinyx announced the publication of three papers in peer-reviewed scientific journals. The publications describe the novel mechanism of action of NYX-2925 and demonstrate that its activation of NMDA receptors leads to enhanced synaptic plasticity, or neuronal communication.

 

·                  Former principal deputy commissioner of the FDA, Rachel Sherman, M.D., joined the company’s Board of Directors. In September 2019, Aptinyx announced that Dr. Sherman joined the company’s Board of Directors. She served at the FDA for nearly 30 years, holding roles of increasing responsibility and influence. Dr. Sherman led numerous key initiatives credited with enhancing product development and facilitating patient access to innovative medicines, including expedited drug development and breakthrough therapy designation programs and the Opioid Policy Steering Committee.

 

Upcoming Milestones

 

·                  Initiation of Phase 2 study of NYX-458 in patients with mild cognitive impairment in Parkinson’s disease in 4Q 2019.

 

·                  Completion of, and reporting data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 2H 2020.

 

·                  Completion of, and reporting top-line data from, Phase 2 study of NYX-2925 in painful DPN in late 2020 or early 2021.

 

·                  Completion of, and reporting top-line data from, Phase 2 study of NYX-2925 in fibromyalgia in 1H 2021.

 

Third Quarter 2019 Financial Results

 

Cash Position: Cash and cash equivalents were $114.2 million at September 30, 2019, compared to $150.6 million at December 31, 2018. The company expects this cash balance to be sufficient to fund anticipated operations into 2021.

 

Collaboration and Grant Revenue: Revenue was $0.9 million for the third quarter of 2019 compared to $0.9 million for same period in 2018. Aptinyx’s revenue was primarily 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 $11.8 million for the third quarter of 2019 compared to $12.0 million for the same period in 2018. The decrease in R&D expenses was primarily driven by a decrease of $2.2 million related to the completion of two Phase 2 studies of NYX-2925, partially offset by a $2.0 million increase in spending related to NYX-783 and NYX-458.

 


 

General and Administrative (G&A) Expenses: G&A expenses were $4.5 million for the third quarter of 2019 compared to $3.8 million for the same period in 2018. The increase in G&A expenses was primarily driven by $0.7 million in increased expenses related to employee compensation, as well as professional fees and insurance costs to support ongoing business operations.

 

Net Loss: Net loss was $14.8 million for the third quarter of 2019 compared to a net loss of $14.2 million for the same period in 2018.

 

Conference Call

 

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 third quarter of 2019 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 4280058. 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.

 

About Aptinyx

 

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.

 

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, 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 into 2021; 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 September 30, 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.

 


 

APTINYX INC.
CONDENSED BALANCE SHEETS
(in thousands)

(Unaudited)

 

 

 

September 30, 2019

 

December 31, 2018

 

Assets

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

 

$

114,214

 

$

150,637

 

Restricted cash

 

179

 

252

 

Accounts receivable

 

461

 

578

 

Prepaid expenses and other current assets

 

3,980

 

1,784

 

Total current assets

 

118,834

 

153,251

 

Property and equipment, net and other long-term assets

 

1,496

 

2,363

 

Total assets

 

$

120,330

 

$

155,614

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable

 

$

1,750

 

$

1,889

 

Accrued expenses and other current liabilities

 

5,344

 

3,996

 

Total current liabilities

 

7,094

 

5,885

 

Other long-term liabilities

 

309

 

418

 

Total liabilities

 

7,403

 

6,303

 

Stockholders’ equity

 

112,927

 

149,311

 

Total liabilities and stockholders’ equity

 

$

120,330

 

$

155,614

 

 


 

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

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2019

 

2018

 

2019

 

2018

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

936

 

$

943

 

$

2,751

 

$

3,893

 

Grant revenue

 

 

 

 

1,642

 

Total revenues

 

936

 

$

943

 

2,751

 

5,535

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

Research and development

 

11,761

 

11,950

 

33,732

 

37,860

 

General and administrative

 

4,523

 

3,782

 

14,419

 

7,853

 

Total operating expenses

 

16,284

 

15,732

 

48,151

 

45,713

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(15,348

)

(14,789

)

(45,400

)

(40,178

)

Other income

 

558

 

608

 

1,768

 

990

 

Net loss and comprehensive loss

 

$

(14,790

)

$

(14,181

)

$

(43,632

)

$

(39,188

)

Net loss per share - basic and diluted

 

$

(0.44

)

$

(0.43

)

$

(1.30

)

$

(2.48

)

Weighted average shares outstanding - basic and diluted

 

33,646

 

33,191

 

33,510

 

15,789

 

 

Investor & Media Contact:

Nick Smith

Aptinyx Inc.

ir@aptinyx.com or corporate@aptinyx.com

847-871-0377

 

 

Source: Aptinyx Inc.