Full Press Release Details
Nkarta Reports Third Quarter 2021 Financial Results and Business Update
SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the third quarter ended September 30, 2021.
"We are on track to achieve key data milestones for our two co-lead programs in 2022 with the recently announced dosing of patients in our clinical trial of NKX019 and further progress in our first-in-human clinical trial of NKX101," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "We continue to be excited about the early advancements we are making in our collaboration with CRISPR Therapeutics on CD70 engineered CAR NK cell and NK plus T cell candidates, and we look forward to sharing updates on potential clinical applications of multiple platform enhancements during the SITC annual meeting."
Pipeline and Platform
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-
bound IL-15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound interleukin-15 (IL-15), a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.
NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of IL-15 for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting. 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 any or all of the following: Nkarta's ability to build and advance its pipeline of clinical and preclinical product candidates; the timing of NKX019 and NKX101 clinical trial data; Nkarta's future manufacturing facility and headquarters and production at the facility; Nkarta's ability to capitalize on the inherent diversity of the innate immune system; the ability of Nkarta's technology to enhance the proliferation, persistence and anti-tumor activity of NK cells and enable off-the-shelf, point-of-care administration; the efficiency and cost of Nkarta's manufacturing processes; the number of doses generated from a manufacturing run; Nkarta's production of clinical supply of NKX019; 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 lack of any products approved for sale and its ability to achieve profitability; 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 intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; 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 Nkarta's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 12, 2021, 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.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 16,616 | $ | 9,828 | $ | 46,111 | $ | 24,950 | ||||||||
| General and administrative | 5,812 | 3,918 | 17,431 | 8,560 | ||||||||||||
| Total operating expenses | 22,428 | 13,746 | 63,542 | 33,510 | ||||||||||||
| Loss from operations | (22,428 | ) | (13,746 | ) | (63,542 | ) | (33,510 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Change in fair value of preferred stock purchase right liability | - | - | - | (40,163 | ) | |||||||||||
| Interest income | 81 | 206 | 295 | 358 | ||||||||||||
| Other expense, net | (6 | ) | (153 | ) | (14 | ) | (149 | ) | ||||||||
| Total other income (expense), net | 75 | 53 | 281 | (39,954 | ) | |||||||||||
| Net loss | $ | (22,353 | ) | $ | (13,693 | ) | $ | (63,261 | ) | $ | (73,464 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.68 | ) | $ | (0.44 | ) | $ | (1.93 | ) | $ | (6.39 | ) | ||||
| Weighted average shares used to compute net loss per share, basic and diluted | 32,902,723 | 30,981,441 | 32,823,829 | 11,499,327 |
Condensed Balance Sheets
| September 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Cash, cash equivalents, restricted cash and short-term investments | $ | 259,796 | $ | 315,326 | ||||
| Property and equipment, net | 12,151 | 9,350 | ||||||
| Operating lease right-of-use assets | 12,073 | 8,505 | ||||||
| Other assets | 8,445 | 4,469 | ||||||
| Total assets | $ | 292,465 | $ | 337,650 | ||||
| Liabilities and stockholders' equity | ||||||||
| Accounts payable, accrued and other liabilities | $ | 9,643 | $ | 7,511 | ||||
| Operating lease liabilities | 12,811 | 8,919 | ||||||
| Total liabilities | 22,454 | 16,430 | ||||||
| Stockholders' equity | 270,011 | 321,220 | ||||||
| Total liabilities and stockholders' equity | $ | 292,465 | $ | 337,650 |
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