NKTX 8-K
Nkarta, Inc. (NKTX)
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 20, 2020
Nkarta, Inc.
(Exact name of Registrant as Specified in Its Charter)
|
Delaware |
001-39370 |
47-4515206 |
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
|
6000 Shoreline Court, Suite 102 South San Francisco, CA |
|
94080 |
|
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (415) 582-4923
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, $0.0001 par value per share |
|
NKTX
|
|
The Nasdaq Stock Market LLC (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 ☒
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 August 20, 2020, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the second quarter ended June 30, 2020. A copy of the Company’s press release is attached hereto as Exhibit 99.1.
The information in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be, or be deemed, incorporated by reference in any filings under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit Number |
|
Description |
|
|
|
|
|
99.1 |
|
1
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.
|
|
|
Nkarta, Inc. |
|
|
|
|
|
|
|
Date: August 20, 2020 |
|
By: |
/s/ Matthew Plunkett |
|
|
|
|
Matthew Plunkett |
|
|
|
|
Chief Financial Officer |
2
Exhibit 99.1
Nkarta Reports Second Quarter 2020 Financial Results
|
• |
Co-Lead programs on track: NKX101 expected to begin Phase 1 dosing in 4Q 2020 and IND for NKX019 expected to be filed in 1Q 2021 |
|
• |
Completed construction of cGMP clinical manufacturing facility |
|
• |
Completed initial public offering of common stock on July 14, 2020, raising $289.8 million in gross proceeds |
|
• |
Cash and cash equivalents of $341.8 million (pro forma) as of June 30, 2020, believed to be sufficient to fund operations into at least the second half of 2023 |
SOUTH SAN FRANCISCO, Calif., August 20, 2020 -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the second quarter ended June 30, 2020, and highlighted recent corporate accomplishments.
“Nkarta made outstanding progress in the second quarter of 2020 as we pursue our goal of advancing engineered natural killer cells as the next foundation in anti-cancer cell therapy,” said Paul J. Hastings, President and Chief Executive Officer of Nkarta. “With the success of our recently completed initial public offering and the resultant strengthening of our balance sheet, acceptance of our first IND by the FDA for NKX101, construction of our clinical manufacturing facility, and meaningful strides in our pipeline of allogeneic NK cell therapy candidates, we are off to a momentous start as a public company. We are grateful to our employees and collaborators who have supported this high level of execution in the midst of the difficult challenges posed by the COVID-19 pandemic.”
Recent Developments
|
• |
In March and April 2020, Nkarta appointed two new independent directors to its Board of Directors, Laura K. Shawver, Ph.D., President, Chief Executive Officer and Director of Silverback Therapeutics, and Leone Patterson, President of Adverum Biotechnologies. |
|
• |
Nkarta recently completed the construction of its cGMP manufacturing facility in South San Francisco, California, that is designed to enable Nkarta to supply clinical product for its |
|
early-stage clinical trials. Qualification of the facility is in process and Nkarta expects to manufacture NKX019 at this cGMP facility. In a second, final phase of this buildout, Nkarta expects to expand the capabilities of the facility to include the production of retroviral vector, stimulatory cell line and clinical manufacturing of NKX101. |
|
• |
In July 2020, the U.S. Food and Drug Administration cleared Nkarta’s Investigational New Drug Application (IND) for NKX101, an investigational NK cell therapy engineered to target NKG2D ligands. |
|
• |
In July 2020, Nkarta closed the second tranche of its Series B preferred stock financing, with gross proceeds of $64.4 million. |
|
• |
In July 2020, Nkarta completed an initial public offering (IPO) in which it issued and sold 16,100,000 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $289.8 million, before deducting underwriting discounts and commissions and other offering expenses. |
Anticipated Near-term Clinical Milestones
|
• |
In 4Q 2020, Nkarta plans to begin dosing in a Phase 1 clinical trial of NKX101 for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML) and r/r higher risk myelodysplastic syndrome (MDS). |
|
• |
In 1Q 2021, Nkarta expects to file an Investigational New Drug Application (IND) for NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B cell malignancies. |
Second Quarter 2020 Financial Highlights
|
• |
Cash and Cash Equivalents: As of June 30, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $22.1 million, which excludes $54.2 million of the proceeds from the Company’s Series B Second Tranche Financing of $64.4 million which closed on July 1, 2020, as well as the net proceeds from the Company’s July 2020 IPO of $265.5 million. |
|
• |
R&D Expenses: Research & development expenses were $7.9 million for the second quarter of 2020, which includes $0.2 of non-cash stock-based compensation expense. |
|
• |
G&A Expenses: General and administrative expenses were $2.5 million for the second quarter of 2020, which includes $0.3 million of non-cash stock-based compensation expense. |
2
Financial Guidance
|
• |
Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023. The company expects cash and cash equivalents at December 31, 2020 to be in the range of $300 million to $310 million. |
Upcoming Events
|
• |
Executive management plans to participate in a fireside chat at the Cantor Virtual Healthcare Conference on Tuesday, September 15, 2020 at 2:00 PM ET. A webcast of the event will be available on the Investors section of the Nkarta website. http://bit.ly/Nkarta_Events |
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, and engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company’s website at www.nkartatx.com.
Cautionary Note on 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, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Nkarta’s expectations regarding its growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101 and NKX019, including its regulatory plans; [the potential impact of COVID-19 on Nkarta’s ongoing and planned preclinical studies, clinical trials, business and operations;] Nkarta’s plans to participate at upcoming conferences; and Nkarta’s expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its
3
intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.
These and other risks are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Nkarta, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
||||
|
Collaboration revenue |
|
$ |
— |
|
|
$ |
2 |
|
|
$ |
— |
|
|
$ |
115 |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
7,862 |
|
|
|
3,621 |
|
|
|
15,122 |
|
|
|
5,915 |
|
|
General and administrative |
|
|
2,494 |
|
|
|
1,052 |
|
|
|
4,642 |
|
|
|
1,992 |
|
|
Total operating expenses |
|
|
10,356 |
|
|
|
4,673 |
|
|
|
19,764 |
|
|
|
7,907 |
|
|
Loss from operations |
|
|
(10,356 |
) |
|
|
(4,671 |
) |
|
|
(19,764 |
) |
|
|
(7,792 |
) |
|
Other expense, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of preferred stock purchase right liability |
|
|
(40,741 |
) |
|
|
— |
|
|
|
(40,163 |
) |
|
|
— |
|
|
Interest and income (expense), net |
|
|
31 |
|
|
|
(167 |
) |
|
|
156 |
|
|
|
(129 |
) |
|
Total other expense, net |
|
|
(40,710 |
) |
|
|
(167 |
) |
|
|
(40,007 |
) |
|
|
(129 |
) |
|
Net loss |
|
$ |
(51,066 |
) |
|
$ |
(4,838 |
) |
|
$ |
(59,771 |
) |
|
$ |
(7,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(30.06 |
) |
|
$ |
(3.39 |
) |
|
$ |
(36.13 |
) |
|
$ |
(5.79 |
) |
|
Weighted average shares used to compute net loss per share, basic and diluted |
|
|
1,698,560 |
|
|
|
1,426,984 |
|
|
|
1,654,304 |
|
|
|
1,367,686 |
|
4
Condensed Balance Sheets
(in thousands)
(Unaudited)
|
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
21,646 |
|
|
$ |
36,991 |
|
|
Property and equipment, net |
|
|
7,751 |
|
|
|
3,080 |
|
|
Operating lease right-of-use assets |
|
|
9,017 |
|
|
|
7,144 |
|
|
Other assets |
|
|
5,202 |
|
|
|
1,197 |
|
|
Total assets |
|
$ |
43,616 |
|
|
$ |
48,412 |
|
|
Liabilities and stockholders' deficit |
|
|
|
|
|
|
|
|
|
Preferred stock purchase right liability |
|
$ |
41,641 |
|
|
$ |
1,478 |
|
|
Liability to related parties |
|
|
10,245 |
|
|
|
— |
|
|
Operating lease liabilities |
|
|
9,348 |
|
|
|
7,296 |
|
|
Other liabilities |
|
|
6,456 |
|
|
|
5,306 |
|
|
Total liabilities |
|
|
67,690 |
|
|
|
14,080 |
|
|
Convertible preferred stock |
|
|
59,815 |
|
|
|
59,815 |
|
|
Stockholders’ deficit |
|
|
(83,889 |
) |
|
|
(25,483 |
) |
|
Total liabilities and stockholders’ deficit |
|
$ |
43,616 |
|
|
$ |
48,412 |
|
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.