Nkarta Reports First Quarter 2023 Financial Results and Corporate Highlights
Nkarta, Inc. (Nasdaq: NKTX) reported its Q1 2023 financial results and corporate highlights. The company, focused on developing engineered natural killer (NK) cell therapies, announced:
1. Clinical updates for NKX101 expected in Q2 2023 and NKX019 in H2 2023.
2. Cash and cash equivalents of $332.1 million as of March 31, 2023.
3. Cash runway anticipated to fund operations into 2025.
4. Net loss of $30.8 million, or $0.63 per share, for Q1 2023.
5. R&D expenses of $26.1 million and G&A expenses of $8.2 million for Q1 2023.
The company plans to present additional clinical data for both NKX101 and NKX019 in their respective ongoing Phase 1 trials. Nkarta also announced the resignation of its CFO and business officer, Nadir Mahmood, PhD, effective June 30, 2023.
Nkarta, Inc. (Nasdaq: NKTX) ha riportato i risultati finanziari del Q1 2023 e i punti salienti aziendali. L'azienda, focalizzata nello sviluppo di terapie cellulari ingegnerizzate per le cellule natural killer (NK), ha annunciato:
1. Aggiornamenti clinici per NKX101 previsti nel Q2 2023 e NKX019 nel H2 2023.
2. Disponibilità di liquidità e equivalenti pari a 332,1 milioni di dollari al 31 marzo 2023.
3. La disponibilità di liquidità è prevista per finanziare le operazioni fino al 2025.
4. Una perdita netta di 30,8 milioni di dollari, ovvero 0,63 dollari per azione, per il Q1 2023.
5. Spese per ricerca e sviluppo pari a 26,1 milioni di dollari e spese generali e amministrative di 8,2 milioni di dollari per il Q1 2023.
L'azienda prevede di presentare ulteriori dati clinici sia per NKX101 che per NKX019 nei rispettivi studi di Fase 1 in corso. Nkarta ha anche annunciato le dimissioni del suo CFO e responsabile aziendale, Nadir Mahmood, PhD, con effetto dal 30 giugno 2023.
Nkarta, Inc. (Nasdaq: NKTX) informó sobre sus resultados financieros del Q1 2023 y los aspectos destacados de la empresa. La compañía, centrada en el desarrollo de terapias con células asesinas naturales (NK) ingenierizadas, anunció:
1. Actualizaciones clínicas para NKX101 esperadas en el Q2 2023 y NKX019 en el H2 2023.
2. Efectivo y equivalentes de efectivo de 332,1 millones de dólares a fecha del 31 de marzo de 2023.
3. Se anticipa que la disponibilidad de efectivo financie las operaciones hasta 2025.
4. Pérdida neta de 30,8 millones de dólares, o $0,63 por acción, para el Q1 2023.
5. Gastos de I+D de 26,1 millones de dólares y gastos generales y administrativos de 8,2 millones de dólares para el Q1 2023.
La compañía planea presentar datos clínicos adicionales para NKX101 y NKX019 en sus respectivos ensayos de Fase 1 en curso. Nkarta también anunció la renuncia de su CFO y responsable de negocios, Nadir Mahmood, PhD, efectivo el 30 de junio de 2023.
Nkarta, Inc. (Nasdaq: NKTX)는 2023년 1분기 재무 결과 및 기업 하이라이트를 보고했습니다. 엔지니어링된 자연 킬러(NK) 세포 치료제 개발에 집중하는 이 회사는 다음과 같은 내용을 발표했습니다:
1. NKX101에 대한 임상 업데이트가 2023년 2분기에, NKX019는 2023년 하반기에 예정되어 있습니다.
2. 2023년 3월 31일 기준으로 3억 3,210만 달러의 현금 및 현금성 자산 보유.
3. 운영 자금을 지원하기 위한 현금 소진 예상 시점은 2025년까지입니다.
4. 2023년 1분기 총 3,080만 달러의 순손실, 주당 0.63 달러입니다.
5. 2023년 1분기 연구 개발 비용은 2,610만 달러, 일반 관리 비용은 820만 달러입니다.
회사는 각각 진행 중인 1상 임상시험에서 NKX101과 NKX019에 대한 추가 임상 데이터를 발표할 계획입니다. Nkarta는 또한 CFO이자 사업 책임자인 Nadir Mahmood 박사가 2023년 6월 30일부로 사임한다고 발표했습니다.
Nkarta, Inc. (Nasdaq: NKTX) a publié ses résultats financiers pour le 1er trimestre 2023 ainsi que les points saillants de l'entreprise. La société, qui se concentre sur le développement de thérapies par cellules tueuses naturelles (NK) ingénierées, a annoncé :
1. Mises à jour cliniques pour NKX101 attendues au 2ème trimestre 2023 et NKX019 au 2ème semestre 2023.
2. Liquidités et équivalents de liquidités de 332,1 millions de dollars au 31 mars 2023.
3. Une trésorerie suffisante pour financer les opérations jusqu'en 2025.
4. Une perte nette de 30,8 millions de dollars, soit 0,63 dollar par action, pour le 1er trimestre 2023.
5. Des dépenses de R&D de 26,1 millions de dollars et des dépenses générales et administratives de 8,2 millions de dollars pour le 1er trimestre 2023.
La société prévoit de présenter des données cliniques supplémentaires pour NKX101 et NKX019 dans leurs essais de Phase 1 en cours. Nkarta a également annoncé la démission de son CFO et directeur commercial, Nadir Mahmood, PhD, à compter du 30 juin 2023.
Nkarta, Inc. (Nasdaq: NKTX) hat seine finanziellen Ergebnisse und Unternehmenshighlights für das 1. Quartal 2023 veröffentlicht. Das Unternehmen, das sich auf die Entwicklung von gentechnisch veränderten natürlichen Killer(NK)-Zelltherapien konzentriert, gab Folgendes bekannt:
1. Klinische Updates für NKX101 werden im 2. Quartal 2023 und NKX019 im 2. Halbjahr 2023 erwartet.
2. Bargeld und Bargeldäquivalente von 332,1 Millionen Dollar zum 31. März 2023.
3. Der Cash-Bedarf wird voraussichtlich bis 2025 zur Finanzierung des Betriebs ausreichen.
4. Net Loss von 30,8 Millionen Dollar oder 0,63 Dollar pro Aktie für das 1. Quartal 2023.
5. F&E-Ausgaben von 26,1 Millionen Dollar und allgemeine Verwaltungsaufwendungen von 8,2 Millionen Dollar für das 1. Quartal 2023.
Das Unternehmen plant, zusätzliche klinische Daten für NKX101 und NKX019 in den jeweiligen laufenden Phase-1-Studien zu präsentieren. Nkarta gab auch die Rücktrittsankündigung von CFO und Business Officer Nadir Mahmood, PhD, mit Wirkung zum 30. Juni 2023 bekannt.
- Strong cash position of $332.1 million as of March 31, 2023
- Cash runway expected to fund operations into 2025
- Upcoming clinical updates for NKX101 and NKX019 in 2023
- Expansion of NKX019 trial to include combination therapy with rituximab
- Net loss of $30.8 million for Q1 2023
- Resignation of CFO and business officer, Nadir Mahmood
- Clinical updates on track for NKX101 in second quarter of 2023 at a company-hosted event and NKX019 in second half of 2023
- Cash and cash equivalents of
$332.1 million on March 31, 2023 - Cash runway anticipated to fund operations into 2025
SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the first quarter ended March 31, 2023.
“Nkarta remains focused on the potential of donor-derived CAR NK cell products to broaden access to the transformative power of cell therapy for patients,” said Paul J. Hastings, CEO and President of Nkarta. “We look forward to announcing clinical updates for our two lead programs, NKX101 and NKX019, in 2023.”
Hastings continued, “Our update on NKX101 is expected to include responses from multiple new patients with r/r AML at the 1.5 billion cell dose level. This will include patients from an expansion cohort where cytarabine is substituted for cyclophosphamide and combined with fludarabine as a modified lymphodepletion regimen. Based on our early, encouraging safety data, we see the possibility to combine with other standard of care agents as a potential advantage that NK cell therapy may have over other available treatments. For NKX019, we continue to plan for a full update on non-Hodgkin lymphoma in the second half of the year.”
Clinical Program Updates
NKX101
- NKX101 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target NKG2D ligands on cancer cells.
- Nkarta plans to present additional clinical data in the second quarter of 2023 from its ongoing Phase 1 clinical trial of NKX101 in patients with relapsed or refractory acute myeloid leukemia (r/r AML).
- The update for NKX101 is expected to include longer-term follow up from patients who were in response as of the previous April 2022 data cut-off; clinical data from at least 10 new r/r AML patients treated at 1.5 billion cells/dose x 3 dose regimen; clinical data from patients who received one or more additional 3-dose cycles of NKX101; and clinical data from a new cohort of patients who received lymphodepletion with cytarabine and fludarabine.
NKX019
- NKX019 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target the B-cell antigen CD19.
- Nkarta plans to present additional clinical data in the second half of 2023 from its ongoing Phase 1 clinical trial of NKX019 in patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL).
- The update for NKX019 is expected to include longer-term follow up of patient outcomes reported in the December 2022 announcement of dose expansion data, including patients eligible for retreatment with NKX019. The update is also expected to include clinical data from the recently opened dose expansion study, which is enrolling patients into three cohorts: NKX019 in patients who have not previously received autologous CD19 CAR T therapy, NKX019 in patients who previously received autologous CD19 CAR T therapy, and NKX019 as combination therapy with rituximab to evaluate for enhanced anti-tumor activity via ADCC, a tumor killing mechanism driven by antibodies.
- Prior to the clinical update in the second half of 2023, Nkarta plans to present clinical data at two scientific meetings in June 2023: the annual meeting of the European Hematology Association (EHA) and the International Conference on Malignant Lymphoma (17-ICML). These presentations will be based on the prior November 2022 data cut-off.
AACR 2023
- In April 2023, Nkarta presented preclinical data in two posters at the 2023 American Association of Cancer Research (AACR) annual meeting that showed CD16-mediated ADCC activity by combining NKX101 with a monoclonal antibody and enhancements of cytotoxic activity through genome engineering of NK cells.
Other Corporate Highlights
- In March 2023, Nkarta announced that Nadir Mahmood, PhD, resigned his position as chief financial and business officer to become the chief executive officer of a private biotechnology company. Dr. Mahmood will remain with Nkarta until June 30, 2023, to ensure a smooth transition. Nkarta is currently conducting a search for its next chief financial officer.
First Quarter 2023 and Recent Financial Highlights
- Cash and Cash Equivalents: As of March 31, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of
$332.1 million . - R&D Expenses: Research and development (R&D) expenses were
$26.1 million for the first quarter of 2023. Non-cash stock-based compensation expense included in R&D expense was$2.1 million for the first quarter of 2023. - G&A Expenses: General and administrative (G&A) expenses were
$8.2 million for the first quarter of 2023. Non-cash stock-based compensation expense included in G&A expense was$2.7 million for the first quarter of 2023. - Net Loss: Net loss was
$30.8 million , or$0.63 per basic and diluted share, for the first quarter of 2023. This net loss includes non-cash charges of$3.8 million that consisted primarily of share-based compensation of$4.7 million .
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with 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. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer 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 CAR for enhanced tumor 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 and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.
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 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, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s ability to advance its pipeline as planned, including its NKX101 and NKX019 clinical programs; the promise, anti-tumor activity, tolerability, and accessibility of allogeneic NK cell therapy and Nkarta’s product candidates, including NKX101 and NKX019; the timing of release of additional NKX019 and NKX101 clinical trial data and the nature of the data to be released; and Nkarta’s expected cash runway.
Because forward-looking 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 its two 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; the availability of components and supplies necessary for the conduct of our clinical trials; and risks relating to the impact on Nkarta’s 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 Annual Report on Form 10-K for the quarter and year ended December 31, 2022, filed with the SEC on March 16, 2023, 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 March 31, | |||||||
| 2023 | 2022 | ||||||
| Operating expenses | |||||||
| Research and development | $ | 26,135 | $ | 19,568 | |||
| General and administrative | 8,178 | 6,530 | |||||
| Total operating expenses | 34,313 | 26,098 | |||||
| Loss from operations | (34,313 | ) | (26,098 | ) | |||
| Other income (expense), net: | |||||||
| Interest income | 3,465 | 112 | |||||
| Other income (expense), net | 33 | (1 | ) | ||||
| Total other income, net | 3,498 | 111 | |||||
| Net loss | $ | (30,815 | ) | $ | (25,987 | ) | |
| Net loss per share, basic and diluted | $ | (0.63 | ) | $ | (0.79 | ) | |
| Weighted average shares used to compute net loss per share, basic and diluted | 48,921,326 | 32,992,582 | |||||
Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
| March 31, 2023 | December 31, 2022 | |||||
| Assets | ||||||
| Cash, cash equivalents, restricted cash and investments | $ | 332,100 | $ | 354,886 | ||
| Property and equipment, net | 69,777 | 61,908 | ||||
| Operating lease right-of-use assets | 45,575 | 45,749 | ||||
| Other assets | 10,717 | 10,395 | ||||
| Total assets | $ | 458,169 | $ | 472,938 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable, accrued and other liabilities | $ | 20,229 | $ | 17,797 | ||
| Operating lease liabilities | 91,294 | 82,934 | ||||
| Total liabilities | 111,523 | 100,731 | ||||
| Stockholders’ equity | 346,646 | 372,207 | ||||
| Total liabilities and stockholders’ equity | $ | 458,169 | $ | 472,938 | ||
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
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