Nkarta Reports Third Quarter 2024 Financial Results and Corporate Highlights
Nkarta (NKTX) reported Q3 2024 financial results and corporate updates. The company has initiated patient dosing in both Ntrust-1 and investigator-sponsored trials of NKX019 for autoimmune diseases. Cash position stands at $405.3 million, expected to fund operations into late 2027. The company reported a net loss of $28.3 million ($0.39 per share) for Q3. Notably, Nkarta has decided to discontinue NKX019 development in lymphoma to focus on autoimmune diseases. Preliminary clinical data from Ntrust-1 and Ntrust-2 trials is planned for 2025.
Nkarta (NKTX) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha avviato la somministrazione ai pazienti sia nello studio Ntrust-1 che negli studi sponsorizzati dagli investigatori del NKX019 per le malattie autoimmuni. La posizione di liquidità è di 405,3 milioni di dollari, si prevede che finanzierà le operazioni fino alla fine del 2027. L'azienda ha segnalato una perdita netta di 28,3 milioni di dollari (0,39 dollari per azione) per il terzo trimestre. È importante notare che Nkarta ha deciso di interrompere lo sviluppo di NKX019 per il linfoma per concentrarsi sulle malattie autoimmuni. I dati clinici preliminari dagli studi Ntrust-1 e Ntrust-2 sono previsti per il 2025.
Nkarta (NKTX) informó los resultados financieros del tercer trimestre de 2024 y actualizaciones corporativas. La compañía ha iniciado la dosificación de pacientes en ensayos Ntrust-1 y ensayos patrocinados por investigadores de NKX019 para enfermedades autoinmunes. La posición de efectivo se situa en 405,3 millones de dólares, y se espera que financie las operaciones hasta finales de 2027. La empresa reportó una pérdida neta de 28,3 millones de dólares (0,39 dólares por acción) para el tercer trimestre. Cabe destacar que Nkarta ha decidido interrumpir el desarrollo de NKX019 en linfoma para enfocarse en enfermedades autoinmunes. Se prevé que los datos clínicos preliminares de los ensayos Ntrust-1 y Ntrust-2 estén disponibles para 2025.
Nkarta (NKTX)가 2024년 3분기 재무 결과와 기업 업데이트를 발표했습니다. 이 회사는 자가면역 질환을 위한 NKX019의 Ntrust-1 및 연구자 주관 시험에서 환자 투약을 시작했습니다. 현금 보유액은 4억 530만 달러입니다, 2027년 말까지 운영 자금으로 예상됩니다. 이 회사는 3분기에 대해 2830만 달러의 순손실(주당 0.39 달러)을 보고했습니다. 특히, Nkarta는 자가면역 질환에 집중하기 위해 림프종에서 NKX019 개발을 중단하기로 결정했습니다. Ntrust-1 및 Ntrust-2 시험의 초기 임상 데이터는 2025년을 목표로 하고 있습니다.
Nkarta (NKTX) a publié les résultats financiers du troisième trimestre 2024 et des mises à jour sur l'entreprise. La société a commencé à administrer des traitements aux patients dans les essais Ntrust-1 et dans des essais sponsorisés par des investigateurs pour NKX019 dans le cadre de maladies auto-immunes. La position de trésorerie s'élève à 405,3 millions de dollars, et devrait financer les opérations jusqu'à la fin de 2027. La société a annoncé une perte nette de 28,3 millions de dollars (0,39 dollar par action) pour le troisième trimestre. Il est à noter que Nkarta a décidé d'arrêter le développement de NKX019 pour le lymphome afin de se concentrer sur les maladies auto-immunes. Des données cliniques préliminaires des essais Ntrust-1 et Ntrust-2 sont prévues pour 2025.
Nkarta (NKTX) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Unternehmensaktualisierungen veröffentlicht. Das Unternehmen hat mit der Patientendosierung in sowohl Ntrust-1 als auch in von Prüfern unterstützten Studien von NKX019 für autoimmune Erkrankungen begonnen. Die Liquiditätsposition beträgt 405,3 Millionen Dollar und wird voraussichtlich die Geschäfte bis Ende 2027 finanzieren. Das Unternehmen berichtete von einem netto Verlust von 28,3 Millionen Dollar (0,39 Dollar pro Aktie) für das dritte Quartal. Bemerkenswert ist, dass Nkarta beschlossen hat, die Entwicklung von NKX019 bei Lymphomen einzustellen, um sich auf autoimmune Erkrankungen zu konzentrieren. Vorläufige klinische Daten aus den Ntrust-1 und Ntrust-2 Studien sind für 2025 geplant.
- Strong cash position of $405.3 million, providing runway into late 2027
- Successful initiation of patient dosing in two clinical trials for autoimmune diseases
- Positive safety profile in LBCL cohort with no severe CRS or ICANS cases
- Net loss of $28.3 million in Q3 2024
- Discontinuation of NKX019 development in non-Hodgkin lymphoma
- durability in LBCL results with only one complete response
Insights
The Q3 financial results reveal a solid cash position of
The company's decision to discontinue NHL development despite showing some efficacy (5 out of 7 patients achieving partial response) suggests a realistic assessment of market opportunities and competition in the oncology space. The focus on autoimmune diseases could potentially offer better differentiation and market positioning, though it represents a longer development timeline.
The strategic realignment towards autoimmune diseases marks a significant shift in Nkarta's therapeutic focus. The advancement of NKX019 through multiple trials (Ntrust-1 for lupus nephritis and Ntrust-2 for systemic sclerosis, myositis and vasculitis) demonstrates a comprehensive approach to autoimmune conditions. The safety profile in NHL patients, showing no severe CRS or ICANS, supports the potential application in autoimmune diseases where safety margins are crucial.
The preliminary efficacy in NHL patients (
- First patient dosed in each of Ntrust-1 and investigator-sponsored clinical trial (IST) of NKX019; enrollment ongoing in both studies
- Enrollment in Ntrust-2 expected to initiate by year-end 2024
- Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical trials planned for 2025
- No further NKX019 development in lymphoma planned
- Platform prioritized to focus on advancement of NKX019 for multiple autoimmune diseases
- Cash balance of
$405.3 million on September 30, 2024, including cash, cash equivalents and investments, expected to fund operations into late 2027
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the third quarter ended September 30, 2024.
"We’re encouraged by the early progress that we’ve made in the clinical investigation of NKX019 for autoimmune disease,” said Paul J. Hastings, CEO of Nkarta. “Having dosed a first patient in both Ntrust-1 and the Columbia University Irving Medical Center IST, our learnings can help us optimize the execution of our current and future clinical trials. This includes our Ntrust-2 trial, which is on track to initiate enrollment later this year. Safety and accessibility are paramount in autoimmune disease, and we believe that an off-the-shelf, engineered NK cell therapy has the greatest potential to help patients.”
Hastings continued, “We have decided to forgo future development of NKX019 in non-Hodgkin lymphoma. In reviewing the clinical data from the latest cohort of patients with large B-cell lymphoma and the evolving treatment landscape, Nkarta will focus its efforts on autoimmune diseases, where we believe NKX019 has potential to transform patient care.”
Clinical development of NKX019 for autoimmune diseases advances
- Dosing of the first patient in Ntrust-1, a clinical trial of NKX019 for the treatment of lupus nephritis. As previously announced, the first Ntrust-1 patient entered screening in June 2024.
- Dosing of the first patient in the IST of NKX019 in systemic lupus erythematosus at Columbia University Irving Medical Center (CUIMC). As previously announced, the CUIMC IST was initiated in July 2024.
- Both studies continue to enroll participants.
Anticipated autoimmune milestones 2024-2025
- Initiation of patient enrollment expected by year-end 2024 in Ntrust-2, a clinical trial of NKX019 for the treatment of systemic sclerosis, myositis and vasculitis. As previously announced, the Investigational New Drug (IND) Application for Ntrust-2 cleared in June 2024.
- Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical trials planned for 2025.
Update for NKX019 in non-Hodgkin lymphoma (NHL)
- A cohort of seven patients with heavily pretreated large B-cell lymphoma (LBCL) whose disease progressed following treatment with a CD19 CAR T-cell therapy received NKX019 on Days 0, 3, and 7 following lymphodepletion.
- There were no cases of Grade >2 cytokine release syndrome (CRS) and no cases of immune effector cell-associated neurotoxicity (ICANS).
- Five patients achieved a partial response after a first cycle of treatment. One of these five patients achieved a complete response with >6 months durability after receiving a second cycle of treatment.
- Nkarta aims to report final data from the LBCL cohort at a future medical conference.
- Nkarta will forgo further development in NHL and prioritize development efforts on autoimmune diseases.
Third Quarter 2024 and Recent Financial Highlights
- Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of
$405.3 million as of September 30, 2024. - Research and development (R&D) expenses were
$25.3 million for the third quarter of 2024. Non-cash stock-based compensation expense included in R&D expense was$1.8 million for the third quarter of 2024. - General and administrative (G&A) expenses were
$8.5 million for the third quarter of 2024. Non-cash stock-based compensation expense included in G&A expense was$2.3 million for the third quarter of 2024. - Net loss was
$28.3 million , or$0.39 per basic and diluted share, for the third quarter of 2024. This net loss includes non-cash charges of$5.8 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into late 2027.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.
About Ntrust™ Clinical Trials in Autoimmune Disease
Ntrust-1 and Ntrust-2 are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a “reset” of the immune system through the elimination of pathogenic B cells. Per the trial protocols, patients receive three-dose cycles of NKX019 at 1 billion or 1.5 billion cells per dose following single-agent lymphodepletion with cyclophosphamide, an agent with an established safety profile across autoimmune diseases. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval.
In the Ntrust-1 study (NCT06557265), patients with refractory lupus nephritis receive three-dose cycles of NKX019 following lymphodepletion. Patients in Ntrust-1 may also receive additional cycles to restore response.
Once initiated, Ntrust-2 will enroll patients with systemic sclerosis (scleroderma), idiopathic inflammatory myopathy (myositis), and ANCA-associated vasculitis into parallel cohorts, and NKX019 will be dosed on Days 0, 3, and 7, a regimen that may be advantageous across all Nkarta clinical trials. Each trial is designed to initially enroll up to 12 patients.
About the Investigator-Sponsored Clinical Trial of NKX019 for Systemic Lupus Nephritis
The single-center, single-arm, open-label Phase 1 investigator-sponsored clinical trial is designed to enroll up to 6 patients with systemic lupus erythematosus, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are also planned. Patients receive NKX019 following single-agent lymphodepletion with cyclophosphamide. The clinical trial is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at Columbia University Irving Medical Center and the Director of Rheumatology Clinical Trials.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. 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 therapeutic 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, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of NKX019 (including initiation of further clinical trials such as Ntrust-2 and the future availability and disclosure of clinical data and other updates from Nkarta’s clinical trials); the therapeutic potential, accessibility, tolerability, advantages, and safety profile of NK cell therapies, including NKX019 for the treatment of autoimmune diseases, lupus, systemic sclerosis, myositis, and vasculitis, and NHL; and Nkarta’s expected cash runway. Interim clinical data for NKX019 included in this press release are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available.
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; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling or completing its 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; and the complexity of the manufacturing process for CAR NK cell therapies.
These and other risks and uncertainties 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, 2024, filed with the SEC on August 13, 2024, and Nkarta’s 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 September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 25,250 | $ | 22,194 | $ | 73,617 | $ | 73,451 | |||||||
| General and administrative | 8,544 | 7,100 | 23,654 | 27,014 | |||||||||||
| Total operating expenses | 33,794 | 29,294 | 97,271 | 100,465 | |||||||||||
| Loss from operations | (33,794 | ) | (29,294 | ) | (97,271 | ) | (100,465 | ) | |||||||
| Other income, net: | |||||||||||||||
| Interest income | 5,453 | 3,616 | 14,423 | 10,651 | |||||||||||
| Other (expense) income, net | (3 | ) | 33 | (7 | ) | 67 | |||||||||
| Total other income, net | 5,450 | 3,649 | 14,416 | 10,718 | |||||||||||
| Net loss | $ | (28,344 | ) | $ | (25,645 | ) | $ | (82,855 | ) | $ | (89,747 | ) | |||
| Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (0.52 | ) | $ | (1.26 | ) | $ | (1.83 | ) | |||
| Weighted average shares used to compute net loss per share, basic and diluted | 73,563,316 | 49,062,799 | 65,941,355 | 48,985,373 | |||||||||||
| Nkarta, Inc. Condensed Balance Sheets (in thousands) (Unaudited) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Cash, cash equivalents, restricted cash and investments | $ | 405,265 | $ | 250,932 | |||
| Property and equipment, net | 76,231 | 79,326 | |||||
| Operating lease right-of-use assets | 38,804 | 39,949 | |||||
| Other assets | 11,734 | 8,678 | |||||
| Total assets | $ | 532,034 | $ | 378,885 | |||
| Liabilities and stockholders' equity | |||||||
| Accounts payable, accrued and other liabilities | $ | 15,712 | $ | 17,261 | |||
| Operating lease liabilities | 85,449 | 88,339 | |||||
| Total liabilities | 101,161 | 105,600 | |||||
| Stockholders’ equity | 430,873 | 273,285 | |||||
| Total liabilities and stockholders’ equity | $ | 532,034 | $ | 378,885 | |||
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
FAQ
What was Nkarta's (NKTX) cash position in Q3 2024?
What was Nkarta's (NKTX) net loss in Q3 2024?
Why did Nkarta (NKTX) discontinue NKX019 development in lymphoma?
When will Nkarta (NKTX) release preliminary data from Ntrust-1 and Ntrust-2 trials?
