Form 8-K Aptinyx Inc. For: Aug 12
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): August 12, 2019
APTINYX INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-38535 |
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47-4626057 |
(State or other jurisdiction |
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(Commission |
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(I.R.S. Employer |
909 Davis Street, Suite 600
Evanston, IL 60201
(Address of principal executive offices, including zip code)
(847) 871-0377
(Registrants telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: |
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Trading Symbol(s) |
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Name of each exchange on which registered: |
Common Stock, par value $0.01 per share |
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APTX |
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The Nasdaq Global Select Market |
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
Item 2.02. Results of Operations and Financial Condition.
On August 12, 2019, Aptinyx Inc., issued a press release announcing its financial results for the quarter ended June 30, 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. |
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Description |
99.1 |
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Press Release issued by Aptinyx Inc. on August 12, 2019, furnished herewith |
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.
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Aptinyx Inc. | |
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Date: August 12, 2019 |
By: |
/s/ Ashish Khanna |
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Ashish Khanna |
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Chief Financial Officer and Chief Business Officer |
Aptinyx Reports Second Quarter 2019 Financial Results and Highlights
Reported that NYX-2925 met primary and secondary endpoints in Phase 2 fibromyalgia study
On track to initiate three additional Phase 2 studies in 2H 2019 across pipeline of CNS product candidates
Conference call today at 8:00 a.m. ET
EVANSTON, Ill., August 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 second quarter of 2019 and recent highlights.
We made substantial business and clinical progress in the second quarter, said Norbert Riedel, Ph.D., president and chief executive officer at Aptinyx. The positive results on both primary and secondary endpoints in our Phase 2 study of NYX-2925 in fibromyalgia have afforded us remarkable understanding of the activity of this compound. Those results demonstrate conclusively that NYX-2925 is not only present in the brain, but also that it has positive activity on brain biomarkers known to be associated with the processing of centralized pain. Moreover, both the fibromyalgia study and the results in patients with advanced diabetic peripheral neuropathy provide evidence that this activity of NYX-2925 can result in improvement of pain and other patient-reported symptoms in these disorders. We will seek to further validate these effects on symptom alleviation in our follow-up Phase 2 studies in both fibromyalgia and DPN, to begin in the coming months. Along with our first-in-patient studies of NYX-783 in PTSD, currently enrolling, and of NYX-458 in cognitive impairment in Parkinsons disease, to kick off later this year, we will have four Phase 2 studies ongoing by the end of 2019 that will offer key development insights across our pipeline over the next 12 to 24 months.
Second Quarter 2019 and Recent Highlights
· Reported that NYX-2925 met primary and secondary endpoints in a Phase 2 study in patients with fibromyalgia. In June 2019, Aptinyx reported positive results from a Phase 2 neuroimaging study of NYX-2925 in patients with fibromyalgia. In the study, administration of NYX-2925 resulted in statistically significant effects on the primary endpoint, neuroimaging biomarkers associated with pain processing. NYX-2925 demonstrated statistically significant reductions in connectivity and glutamate levels in brain regions that are known to be involved in the processing of centralized chronic pain. Statistically significant effects were also observed on secondary endpoints, including improvements in patient-reported pain and other symptoms of fibromyalgia. The company expects to initiate a Phase 2 fibromyalgia study focused on patient-reported symptoms in the second half of 2019.
· Reported data demonstrating robust activity of NYX-783 on alcohol-seeking behavior and relapse-like behavior in multiple preclinical models of alcohol use disorder. In June 2019, Aptinyx reported findings from preclinical studies that support the potential of NYX-783 in treating alcohol use disorder. In an alcohol-dependence model and a stress-induced alcohol-seeking model, rodents dosed with NYX-783
showed significantly more rapid elimination of alcohol-seeking behavior compared to vehicle-treated rodents. NYX-783 also led to significantly less relapse-like behavior across both models. These data support the continued evaluation of NYX-783 and indicate that NYX-783 may be an effective approach to addressing alcohol abuse in patients with or without comorbid PTSD.
Upcoming Milestones
· Initiation of Phase 2 study of NYX-2925 in patients with painful diabetic neuropathy in 2H 2019.
· Initiation of Phase 2 study of NYX-2925 in patients with fibromyalgia in 2H 2019.
· Initiation of Phase 2 study of NYX-458 in patients with mild cognitive impairment in Parkinsons disease in 2H 2019.
· Completion of, and reporting top-line data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 2H 2020.
Second Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were $124.9 million at June 30, 2019 compared to $150.6 million at December 31, 2018.
Collaboration and Grant Revenue: Revenue was $0.9 million for the second quarter of 2019 compared to $2.1 million for same period in 2018. Aptinyxs revenue was primarily derived from its research collaboration agreement with Allergan and government grants. The decrease was primarily driven by the option fee received in 2018 in connection with Allergans exercise of its option to acquire AGN-241751. The company does not rely on these revenues to fund its operations.
Research and Development (R&D) Expenses: R&D expenses were $9.5 million for the second quarter of 2019 compared to $13.7 million for the same period in 2018. The decrease in R&D expenses was primarily due to the completion of studies that were ongoing in the first half of 2018.
General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the second quarter of 2019 compared to $2.0 million for the same period in 2018. The increase in G&A expenses was primarily driven by $1.2 million in increased costs related to employee compensation, including $0.9 million of additional non-cash stock-based compensation expenses, as well as $0.9 million of increased professional fees and insurance costs to support ongoing business operations and compliance associated with being a publicly traded company.
Net Loss: Net loss was $12.1 million for the second quarter of 2019 compared to a net loss of $13.3 million for the same period in 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 and highlights for the second quarter of 2019. To access the call, please dial 1-866-930-5579 (domestic) or 1-409-216-0606 (international) and refer to conference ID 9072524. A live webcast of the call will be
available on the Investors & Media section of Aptinyxs 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 modulaterather than block or over-activateNMDA 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 Parkinsons 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 companys business plans and objectives, including future plans or expectations for the companys product candidates, therapeutic effects of the companys product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, the timing for the companys 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 companys product candidate development activities and planned clinical studies; the companys 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 companys estimates regarding expenses, future revenue, and capital requirements, and other financial results; the companys ability to fund operations through 2020; as well as those risks and uncertainties set forth in the companys 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 June 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)
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June 30, 2019 |
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December 31, 2018 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
124,891 |
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$ |
150,637 |
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Restricted cash |
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252 |
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252 |
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Accounts receivable |
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450 |
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578 |
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Prepaid expenses and other current assets |
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2,878 |
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1,784 |
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Total current assets |
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128,471 |
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153,251 |
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Property and equipment, net and other long-term assets |
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1,700 |
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2,363 |
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Total assets |
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$ |
130,171 |
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$ |
155,614 |
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Liabilities and stockholders equity |
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Current Liabilities: |
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Accounts payable |
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$ |
834 |
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$ |
1,889 |
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Accrued expenses and other current liabilities |
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3,944 |
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3,996 |
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Total current liabilities |
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4,778 |
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5,885 |
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Other long-term liabilities |
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347 |
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418 |
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Total liabilities |
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5,125 |
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6,303 |
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Stockholders equity |
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125,046 |
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149,311 |
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Total liabilities and stockholders equity |
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$ |
130,171 |
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$ |
155,614 |
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APTINYX INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenues |
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Collaboration revenue |
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$ |
925 |
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$ |
2,017 |
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$ |
1,815 |
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$ |
2,951 |
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Grant revenue |
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111 |
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1,642 |
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Total revenues |
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925 |
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$ |
2,128 |
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1,815 |
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4,593 |
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Operating expenses |
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Research and development |
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9,481 |
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13,686 |
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21,971 |
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25,911 |
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General and administrative |
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4,171 |
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2,022 |
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9,896 |
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4,071 |
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Total operating expenses |
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13,652 |
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15,708 |
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31,867 |
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29,982 |
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Loss from operations |
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(12,727 |
) |
(13,580 |
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(30,052 |
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(25,389 |
) | ||||
Other income |
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596 |
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245 |
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1,210 |
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382 |
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Net loss and comprehensive loss |
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$ |
(12,131 |
) |
$ |
(13,335 |
) |
$ |
(28,842 |
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$ |
(25,007 |
) |
Net loss per share - basic and diluted |
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$ |
(0.36 |
) |
$ |
(1.83 |
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$ |
(0.86 |
) |
$ |
(3.95 |
) |
Weighted average shares outstanding - basic and diluted |
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33,493 |
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7,275 |
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33,442 |
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6,332 |
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Investor & Media Contact:
Nick Smith
Aptinyx Inc.
[email protected] or [email protected]
847-871-0377
Source: Aptinyx Inc.
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