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): May 14, 2019

 

APTINYX INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-38535

 

47-4626057

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

909 Davis Street, Suite 600

Evanston, IL 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:

 

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 240.13e-4(c))

 

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

 

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

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On May 14, 2019, Aptinyx Inc. issued a press release announcing its financial results for the quarter ended March 31, 2019. 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 May 14, 2019, furnished herewith

 

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: May 14, 2019

By:

/s/ Ashish Khanna

 

 

Ashish Khanna

 

 

Chief Financial Officer and Chief Business Officer

 

3


Exhibit 99.1

 

 

 

Aptinyx Reports First Quarter 2019 Financial Results and Provides Corporate Update

 

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 — 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

 

·                  Reported positive results from Phase 1 study of NYX-458, in development for Parkinson’s disease cognitive impairment: In April 2019, Aptinyx reported positive results from a Phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics, and CNS penetration of NYX-458 in healthy volunteers. In the study, NYX-458 was safe and well tolerated with no serious adverse events reported. NYX-458 exhibited a dose-proportional and predictable pharmacokinetic profile across a very wide dose range. As evaluated through measurement of concentration in cerebral spinal fluid, NYX-458 readily crosses the blood brain barrier and achieves ample CNS exposure in line with that observed at preclinically efficacious doses. The company expects to initiate a Phase 2 study in the second half of 2019.

 

·                  Reported robust analgesic activity of NYX-2925 in advanced DPN patients: In April 2019, Aptinyx presented detailed results from a 300-subject Phase 2 study in patients with painful DPN at the annual meeting of the American Pain Society. While statistically significant separation from placebo was not achieved for the primary endpoint in the total study population, post hoc analysis demonstrated increasing therapeutic benefit of NYX-2925 in patients suffering from DPN for a longer period of time. In particular, the company highlighted results showing that patients in the study who had been diagnosed with DPN for four years or longer (N=127) experienced a clinically meaningful and significant alleviation of their pain with NYX-2925 (p=0.004 vs. placebo). In advanced DPN patients, the 50 mg dose group showed the greatest separation from placebo on the primary efficacy endpoint, and these effects were even more pronounced for patients in this sub-group not taking a concomitant analgesic. These results, which were consistent across the various endpoints in the study, inform the future development of NYX-2925 in chronic pain and the company expects to initiate a Phase 2 study in patients with advanced DPN in the second half of 2019.

 

·                  Presented data showing NYX-458 reversed cognitive deficits in a non-human primate model of Parkinson’s disease: In March 2019, Aptinyx presented findings from two non-human primate studies at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD™) in Lisbon, Portugal. The results from the first study demonstrated that, in a highly translatable model of Parkinson’s disease

 


 

cognitive impairment, NYX-458 reversed cognitive deficits in a rapid, robust, and enduring manner. This study employed chronic low doses of MPTP, a neurotoxin, to deplete dopaminergic neurons and induce cognitive deficits similar to those experienced by patients with Parkinson’s disease. In the second study, using higher doses of MPTP to induce parkinsonian-like motor symptoms, NYX-458 did not worsen motor symptoms or interfere with the anti-parkinsonian effects of levodopa therapy, the standard of care to treat the motor symptoms of Parkinson’s disease.

 

·                  Initiated Phase 2 study of NYX-783 for treatment of PTSD: In February 2019, Aptinyx initiated a Phase 2 clinical study of NYX-783 to characterize its safety, pharmacokinetics, and effects on symptoms in patients with PTSD. Approximately 144 patients will be enrolled and randomly assigned to receive either placebo or NYX-783 over the course of the eight-week study. Multiple efficacy endpoints will be evaluated in the study to assess the impact of NYX-783 across the spectrum of PTSD symptoms. The company expects to report data from this study in the first half of 2020.

 

Recent Operational Highlight:

 

·                  Announced election of Henry Gosebruch to the Board of Directors: In early May, Aptinyx announced the election of industry veteran Henry O. Gosebruch to its board of directors. Mr. Gosebruch is currently executive vice president and chief strategy officer at AbbVie and was formerly co-head of J.P. Morgan’s North American M&A Group. His industry expertise and insights will be valuable as the company expands and moves forward with its pipeline of innovative NMDA receptor-modulating therapy candidates.

 

Expected Near-Term Milestones

 

·                  Completion of, and reporting data from, NYX-2925 exploratory Phase 2 study in fibromyalgia in 1H 2019.

 

·                  Completion of, and reporting top-line data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 1H 2020.

 


 

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.

 

Conference Call

 

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.

 

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 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.

 


 

APTINYX INC.
CONDENSED BALANCE SHEETS
(in thousands)

(Unaudited)

 

 

 

March 31, 2019

 

December 31, 2018

 

Assets

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

 

$

136,580

 

$

150,637

 

Restricted cash

 

252

 

252

 

Accounts receivable

 

415

 

578

 

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

 

Total assets

 

$

140,993

 

$

155,614

 

 

 

 

 

 

 

Liabilities and stockholders’ equity (deficit)

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable

 

$

1,337

 

$

1,889

 

Accrued expenses and other current liabilities

 

4,586

 

3,996

 

Total current liabilities

 

5,923

 

5,885

 

Other long-term liabilities

 

384

 

418

 

Total liabilities

 

6,307

 

6,303

 

Stockholders’ equity (deficit)

 

134,686

 

149,311

 

Total liabilities and stockholders’ equity (deficit)

 

$

140,993

 

$

155,614

 

 


 

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

 

 

 

Three Months Ended
March 31,

 

 

 

2019

 

2018

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

Collaboration revenue

 

$

890

 

$

934

 

Grant revenue

 

 

1,530

 

Total Revenues

 

890

 

2,464

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

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

)

Other income

 

614

 

137

 

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

 

 

Investor & Media Contact:

Nick Smith

Aptinyx Inc.

ir@aptinyx.com or corporate@aptinyx.com

847-871-0377

 

 

Source: Aptinyx Inc.