8-K
Neurogene Inc. (NGNE)
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 6, 2020
Neoleukin Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-36327 | 98-0542593 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer<br><br><br>Identification No.) |
360 - 1616 Eastlake Avenue E,
Seattle, Washington 98102
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (206) 732-2133
NA
(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 (see General Instruction A.2. below):
| ☐ | 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 $0.000001 | NLTX | The Nasdaq Stock Market LLC |
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 ☐
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 6, 2020, Neoleukin Therapeutics, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended March 31, 2020. The full text of the press release announcing such results is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this current report on Form 8-K and the press release attached as Exhibit 99.1 hereto is being furnished, but shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and is not incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|
(d) Exhibits
| Number | Description |
|---|---|
| 99.1 | Press Release of Neoleukin Therapeutics, Inc. dated May 6, 2020 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Neoleukin Therapeutics, Inc. | |
|---|---|
| By: | /s/ Robert Ho |
| Name: | Robert Ho |
| Title: | Chief Financial Officer |
Date: May 6, 2020
nltx-ex99_6.htm
Exhibit 99.1
Neoleukin Therapeutics Announces First Quarter 2020 Financial Results and Provides Business Update
- IND submission for NL-201 anticipated by end of 2020 -
- Three abstracts to be presented at AACR-II -
SEATTLE, Washington, May 6, 2020 – Neoleukin Therapeutics, Inc. (“Neoleukin”) (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced financial results for the first quarter ending March 31, 2020 and provided a business update.
“We look forward to presenting significant updates on our preclinical data for NL-201 as well as additional data related to our de novo protein technology next month at the virtual AACR-II meeting,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. “Our committed team continues to advance NL-201 towards IND, which remains on target for submission by the end of 2020. In addition, our efforts to develop NL-201 and our pipeline are supported by financial runway through 2022.”
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $139.4 million as of March 31, 2020 compared to $143.1 million as of December 31, 2019. Expenses were primarily the result of costs related to advancing our lead product candidate, NL-201, and other Neoleukin technologies. The expenses were partially offset by $3.4 million in proceeds from the exercise of options by employees.
Based upon our current operating plan, Neoleukin believes that its cash-on-hand will be sufficient to fund operations through 2022.
R&D Expenses: Research and development expenses for the first quarter of 2020 increased to $5.5 million from $0.1 million for the first quarter of 2019. This increase was primarily due to IND-enabling activities related to our lead product candidate, NL-201, and advancement of other Neoleukin technologies compared to lower expenses during 2019 as a result of the suspension of all research and development activities with rosiptor in June 2018.
G&A Expenses: General and administrative expenses for the first quarter of 2020 increased to $3.6 million from $2.6 million for the first quarter of 2019. This increase was primarily due to growth in employee headcount in the second half of 2019.
Net Loss: Net loss for the first quarter of 2020 was $8.6 million compared to a net loss of $2.2 million in the first quarter of 2019 primarily due to our focus on our lead candidate, NL-201, and other Neoleukin technologies in 2020.
About Neoleukin Therapeutics, Inc.
Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. Neoleukin’s lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to eliminate alpha receptor binding. For more information, please visit the Neoleukin website: www.neoleukin.com.
Safe Harbor / Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, planned development activities and timelines, use and adequacy of cash reserves and the potential benefits of the company’s product candidates and platform. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the company’s cash forecasts, the company’s ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the company’s clinical trials and related data, and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects. Further information on potential risk factors that could affect Neoleukin’s business and its financial results are detailed under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Neoleukin undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts:
Media
Julie Rathbun
206-769-9219
Investors
Solebury Trout
Brian Korb
646-378-2923
NEOLEUKIN THERAPEUTICS INC.
Condensed consolidated balance sheets
(Unaudited)
(In thousands of U.S. dollars)
| MARCH 31,<br><br><br>2020 | DECEMBER 31,<br><br><br>2019 | |||
|---|---|---|---|---|
| Assets | ||||
| Cash and cash equivalents | $ | 139,417 | $ | 143,093 |
| Other current assets | 236 | 503 | ||
| Other long-term assets | 13,398 | 3,427 | ||
| Total assets | $ | 153,051 | $ | 147,023 |
| Liabilities | ||||
| Current liabilities | $ | 5,603 | $ | 4,743 |
| Non-current liabilities | 10,328 | 593 | ||
| Total liabilities | 15,931 | 5,336 | ||
| Stockholders’ equity | 137,120 | 141,687 | ||
| Total liabilities and stockholders' equity | $ | 153,051 | $ | 147,023 |
NEOLEUKIN THERAPEUTICS, INC.
Condensed consolidated statements of operations
(Unaudited)
(In thousands of U.S. dollars, except per share and share amounts)
| THREE MONTHS ENDED<br><br><br>MARCH 31, | ||||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | |||||
| Operating expenses | ||||||
| Research and development | $ | 5,498 | $ | 104 | ||
| General and administrative | 3,573 | 2,555 | ||||
| Total operating expenses | 9,071 | 2,659 | ||||
| Other income, net | 429 | 451 | ||||
| Net loss | $ | (8,642 | ) | $ | (2,208 | ) |
| Net loss per common stock - basic and diluted | $ | (0.18 | ) | $ | (0.09 | ) |
| Basic and diluted weighted average number of common stock outstanding | 49,168,451 | 23,537,368 |