Nkarta(NKTX)

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Nkarta(NKTX) - 2024 Q1 - Quarterly Results
2024-05-09 20:04
[Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) Nkarta is advancing NKX019 into autoimmune diseases, with first lupus nephritis patient dosing in H1 2024, bolstered by a **$240.1 million** offering extending cash runway to late 2027 - The company is prioritizing the development of its off-the-shelf NK cell product, NKX019, for autoimmune diseases, starting with lupus nephritis, to address patient access and safety concerns associated with existing cell therapies[3](index=3&type=chunk) - In March 2024, Nkarta completed an underwritten offering of common stock and pre-funded warrants, raising gross proceeds of **$240.1 million**[9](index=9&type=chunk) - The company's strong balance sheet, with a cash balance of **$450.0 million** as of March 31, 2024, is expected to fund operations into late 2027[5](index=5&type=chunk)[11](index=11&type=chunk) [Clinical Pipeline Update](index=1&type=section&id=Clinical%20Pipeline%20Update) Nkarta provided updates on NKX019, with first lupus nephritis patient dosing in H1 2024 and promising re-treatment efficacy in NHL, with new data expected mid-2024 [NKX019 in Autoimmune Disease](index=1&type=section&id=NKX019%20in%20Autoimmune%20Disease) Nkarta is advancing its Phase 1 trial of NKX019 for refractory lupus nephritis, with first patient dosing expected in H1 2024 using a cyclophosphamide-only lymphodepletion regimen - The first patient with lupus nephritis is expected to be dosed with NKX019 in the first half of 2024[5](index=5&type=chunk)[7](index=7&type=chunk) - The Phase 1 trial will use a single-agent lymphodepletion regimen with cyclophosphamide, an agent with an established safety profile in lupus nephritis[6](index=6&type=chunk) - Translational data suggest NKX019 has the potential to drive an immunologic reset by efficiently killing B cells and allowing for the recovery of predominantly naïve B cells[6](index=6&type=chunk) [NKX019 in Non-Hodgkin Lymphoma (NHL)](index=2&type=section&id=NKX019%20in%20Non-Hodgkin%20Lymphoma%20%28NHL%29) In r/r NHL, NKX019 demonstrated re-treatment efficacy with complete responses, and a compressed dosing cohort is being evaluated, with preliminary data expected mid-2024 - All **4** r/r NHL patients who had previously achieved a complete response (CR) with NKX019 and subsequently relapsed were able to achieve CR again after re-treatment[12](index=12&type=chunk) - A compressed dosing regimen (Days 0, 3, and 7) is being evaluated to potentially intensify NKX019 exposure[12](index=12&type=chunk) - Preliminary data from the compressed dosing cohort in the r/r NHL trial is expected to be announced in mid-2024[12](index=12&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Nkarta reported a **$29.5 million** net loss for Q1 2024, ending with **$450.0 million** cash, significantly increased by financing, expected to fund operations into late 2027 [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Nkarta ended Q1 2024 with **$450.0 million** in cash, a net loss of **$29.5 million** (**$0.58** per share), and R&D and G&A expenses of **$25.2 million** and **$7.5 million** respectively Q1 2024 Key Financial Metrics | Metric | Q1 2024 | | :--- | :--- | | Cash, Cash Equivalents, and Investments | $450.0 million | | R&D Expenses | $25.2 million | | G&A Expenses | $7.5 million | | Net Loss | $29.5 million | | Net Loss per Share | $0.58 | [Financial Guidance](index=2&type=section&id=Financial%20Guidance) Nkarta projects its current cash and cash equivalents will fund operations into late 2027 - The company projects its current cash and cash equivalents will be sufficient to fund its operating plan into late 2027[11](index=11&type=chunk) [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) For Q1 2024, total operating expenses were **$32.8 million**, down from **$34.3 million** in Q1 2023, with net loss narrowing to **$29.5 million** from **$30.8 million** Condensed Statements of Operations (in thousands) | Line Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $25,237 | $26,135 | | General and administrative | $7,525 | $8,178 | | **Total operating expenses** | **$32,762** | **$34,313** | | Loss from operations | ($32,762) | ($34,313) | | Interest income | $3,246 | $3,465 | | **Net loss** | **($29,518)** | **($30,815)** | | Net loss per share, basic and diluted | ($0.58) | ($0.63) | [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, Nkarta reported total assets of **$576.9 million** and total liabilities of **$103.3 million**, with cash increasing to **$450.0 million** from **$250.9 million** Condensed Balance Sheet Highlights (in thousands) | Line Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and investments | $449,951 | $250,932 | | **Total assets** | **$576,936** | **$378,885** | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $103,285 | $105,600 | | Total stockholders' equity | $473,651 | $273,285 | | **Total liabilities and stockholders' equity** | **$576,936** | **$378,885** | [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) This section details Nkarta's lead candidate, NKX019, an allogeneic, off-the-shelf NK cell therapy, and provides an overview of the clinical-stage company [About NKX019](index=2&type=section&id=About%20NKX019) NKX019 is an allogeneic, cryopreserved, off-the-shelf NK cell immunotherapy engineered with a CD19-directed CAR and membrane-bound IL-15 for enhanced persistence - NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate using natural killer (NK) cells from healthy donors[12](index=12&type=chunk) - The therapy is engineered with a humanized CD19-directed CAR for targeting and a membrane-bound form of IL-15 for greater persistence and activity[13](index=13&type=chunk) [About Nkarta](index=3&type=section&id=About%20Nkarta) Nkarta is a clinical-stage biotechnology company developing allogeneic, off-the-shelf NK cell therapies, leveraging its platforms for broad outpatient access - Nkarta is a clinical-stage biotechnology company focused on advancing allogeneic, off-the-shelf NK cell therapies[14](index=14&type=chunk) - The company's goal is to create therapies with deep activity that are suitable for broad access in an outpatient treatment setting[14](index=14&type=chunk)
Nkarta: Down 50% Since March With A Clinical Catalyst Ahead
Seeking Alpha· 2024-04-27 14:27
Gilnature/iStock via Getty Images Nkarta Inc's (NASDAQ:NKTX) stock has pulled back over 50% from the highs of early March 2024. The name might find support in the $6 range looking at the chart, but to see if there might be some news flow to help that out, it's important to look at the company's pipeline of modified NK cells and upcoming catalysts. Data by YCharts NKTX's pipeline At the top of NKTX's pipeline is NKX019, an allogeneic (off the shelf) chimeric antigen receptor-NK cell, or CAR-NK, targeting ...
Nkarta(NKTX) - 2023 Q4 - Annual Report
2024-03-21 20:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (Exact name of registrant as specified in its charter) Delaware 47-4515206 (State or other jurisdiction of incorporation or organization) 1150 Veterans Boulevard South San Francisco, CA 94080 (Address of principal executive offices) (Zip Code) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 1 ...
Nkarta(NKTX) - 2023 Q4 - Annual Results
2024-03-21 20:15
[Nkarta Q4 and Full Year 2023 Financial Results and Corporate Highlights](index=1&type=section&id=Nkarta%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Corporate%20Highlights) [Corporate Highlights and Strategic Update](index=1&type=section&id=Corporate%20Highlights%20and%20Strategic%20Update) Nkarta prioritizes NKX019 for autoimmune diseases, initiating a H1 2024 trial, deprioritizing NKX101, and has cash into 2026 - Pipeline realignment to focus resources on the rapid advancement of NKX019 in autoimmune diseases, while deprioritizing the development of NKX101[3](index=3&type=chunk)[4](index=4&type=chunk) - The first patient dosing in the clinical trial of NKX019 for lupus nephritis is on track for the first half of 2024[3](index=3&type=chunk)[4](index=4&type=chunk) Financial Position and Runway | Metric | Value | | :--- | :--- | | 2023 Year-End Cash, Cash Equivalents & Investments | $250.9 million | | Anticipated Cash Runway | Into 2026 | [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) Nkarta's clinical programs shift focus, advancing NKX019 for autoimmune diseases and NHL, while deprioritizing NKX101 for AML due to efficacy [NKX019 in Autoimmune Disease (Lupus Nephritis)](index=2&type=section&id=NKX019%20in%20autoimmune%20disease) Nkarta launches a Phase 1 trial for NKX019 in refractory lupus nephritis, with first patient dosing expected in H1 2024 - The FDA has cleared the IND application for NKX019 in lupus nephritis (LN), with the first patient dosing planned for the first half of 2024[7](index=7&type=chunk) - The trial is a multi-center, open-label, dose escalation study for up to 12 patients with refractory LN, using a three-dose cycle at **1 billion** or **1.5 billion** cells per dose[7](index=7&type=chunk) - The lymphodepletion (LD) regimen will use single-agent cyclophosphamide (cy), which has an established safety profile in SLE and LN[7](index=7&type=chunk) [NKX019 in Non-Hodgkin Lymphoma (NHL)](index=2&type=section&id=NKX019%20in%20non-Hodgkin%20lymphoma%20%28NHL%29) Nkarta evaluates a new compressed dosing schedule for NKX019 in r/r NHL, with preliminary data expected mid-2024 - A new cohort (**n=6**) in the Phase 1 study is testing a compressed dosing schedule (Days 0, 3, 7) to intensify NKX019 exposure, with preliminary data expected in mid-2024[7](index=7&type=chunk) - Previous data showed a **70%** complete response (CR) rate (7 of 10 patients) with NKX019 monotherapy at the highest dose levels[7](index=7&type=chunk) - **4 of 4** patients who relapsed after achieving CR were able to achieve CR again after re-treatment, suggesting a lack of resistance to NKX019[7](index=7&type=chunk) [NKX101 in Acute Myeloid Leukemia (AML)](index=3&type=section&id=NKX101%20in%20acute%20myeloid%20leukemia%20%28AML%29) Nkarta deprioritized the NKX101 program and closed enrollment due to lower efficacy data in an expanded AML patient cohort - The company has closed patient enrollment and deprioritized the NKX101 program to focus resources on NKX019 for autoimmune disease[10](index=10&type=chunk) - The decision was based on a review of data from **20 patients** showing a lower aggregate CR/CRi rate (**5 of 20**) than what was observed in the **first 6 patients** in the cohort[10](index=10&type=chunk) - The safety profile of NKX101 was consistent with previously reported data[10](index=10&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) Nkarta reported a net loss of $117.5 million for 2023, ending with $250.9 million in cash, expected to fund operations into 2026 [Financial Highlights & Guidance](index=3&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Highlights) For 2023, Nkarta incurred $96.8 million in R&D and $34.9 million in G&A, resulting in a $117.5 million net loss Full Year 2023 Financial Summary | Metric | Full Year 2023 (USD) | Q4 2023 (USD) | | :--- | :--- | :--- | | R&D Expenses | $96.8 million | $23.3 million | | G&A Expenses | $34.9 million | $7.9 million | | Net Loss | $117.5 million | $27.8 million | | Net Loss per Share | $2.40 | $0.57 | - As of December 31, 2023, Nkarta had cash, cash equivalents, and investments of **$250.9 million**[10](index=10&type=chunk) - The company expects its current cash and cash equivalents will be sufficient to fund its current operating plan **into 2026**[10](index=10&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) The company's net loss for full year 2023 was $117.5 million, increasing from 2022 due to higher operating expenses Statement of Operations (in thousands) | Metric | Year Ended 2023 | Year Ended 2022 | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $96,773 | $90,897 | $23,322 | $26,845 | | General and administrative | $34,877 | $28,058 | $7,863 | $8,138 | | Total operating expenses | $131,650 | $118,955 | $31,185 | $34,983 | | Loss from operations | $(131,650) | $(118,955) | $(31,185) | $(34,983) | | Interest income | $14,107 | $5,588 | $3,456 | $2,890 | | Net loss | $(117,501) | $(113,837) | $(27,754) | $(32,582) | | Net loss per share | $(2.40) | $(2.61) | $(0.57) | $(0.67) | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of December 31, 2023, Nkarta's total assets decreased to $378.9 million, driven by reduced cash and investments Balance Sheet Highlights (in thousands) | Metric | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, restricted cash and short-term investments | $250,932 | $354,886 | | Total assets | $378,885 | $472,938 | | Total liabilities | $105,600 | $100,731 | | Stockholders' equity | $273,285 | $372,207 | [Company and Product Overview](index=4&type=section&id=Company%20and%20Product%20Overview) This section outlines Nkarta's core technology and product candidates, focusing on allogeneic, off-the-shelf NK cell therapies [About NKX019](index=4&type=section&id=About%20NKX019) NKX019 is an allogeneic, off-the-shelf immunotherapy candidate engineered with a CD19-directed CAR and membrane-bound IL-15 - NKX019 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy adult donors[11](index=11&type=chunk) - It is engineered with a humanized CD19-directed CAR for targeting B cells and a membrane-bound IL-15 for enhanced persistence and activity[11](index=11&type=chunk) [About NKX101](index=4&type=section&id=About%20NKX101) NKX101 is an allogeneic, off-the-shelf cancer immunotherapy candidate engineered with a CAR targeting NKG2D ligands - NKX101 is an allogeneic, off-the-shelf NK cell therapy candidate for cancer[12](index=12&type=chunk) - It is engineered with a CAR targeting NKG2D ligands on tumor cells and includes a membrane-bound form of IL-15[12](index=12&type=chunk) [About Nkarta](index=4&type=section&id=About%20Nkarta) Nkarta is a clinical-stage biotech company developing allogeneic, off-the-shelf NK cell therapies using proprietary engineering platforms - Nkarta is a clinical-stage biotech company developing allogeneic, off-the-shelf NK cell therapies[13](index=13&type=chunk) - The company's approach combines cell expansion, cryopreservation, and proprietary engineering technologies for broad access in an outpatient setting[13](index=13&type=chunk) [Forward-Looking Statements and Risk Factors](index=4&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) This section cautions investors that statements regarding future plans and product potential are forward-looking and subject to significant risks - The press release contains forward-looking statements concerning plans, strategies, and timelines for clinical development, therapeutic potential, and financial runway[14](index=14&type=chunk) - Key risks include limited operating history, lack of approved products, unpredictability of clinical trial results, potential for delays, competition, and dependence on third parties for manufacturing and trials[15](index=15&type=chunk)[16](index=16&type=chunk)
Nkarta(NKTX) - 2023 Q3 - Quarterly Report
2023-11-09 21:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39370 Nkarta, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or or ...
Nkarta(NKTX) - 2023 Q2 - Quarterly Report
2023-08-10 11:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39370 Nkarta, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organiz ...
Nkarta(NKTX) - 2023 Q1 - Quarterly Report
2023-05-11 20:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39370 Nkarta, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organi ...
Nkarta(NKTX) - 2022 Q4 - Annual Report
2023-03-16 21:02
Part I [Business](index=6&type=section&id=Item%201.%20Business) Nkarta, Inc. develops allogeneic, off-the-shelf engineered NK cell therapies for cancer, with lead candidates NKX101 and NKX019 in Phase 1 trials, leveraging a proprietary platform and in-house manufacturing - Nkarta is a biopharmaceutical company focused on allogeneic, off-the-shelf engineered natural killer (NK) cell therapies to treat cancer[19](index=19&type=chunk) - The company has two lead product candidates in Phase 1 clinical trials: NKX101 for relapsed or refractory acute myeloid leukemia (r/r AML) or myelodysplastic syndromes (MDS), and NKX019 for B-cell malignancies[19](index=19&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - Nkarta's strategy involves developing its lead candidates, building a broader pipeline using its modular NK cell engineering platform, establishing proprietary cGMP manufacturing capabilities, and opportunistically evaluating new technologies through licenses and collaborations[27](index=27&type=chunk) - The company is collaborating with CRISPR Therapeutics to develop gene-edited NK cell therapies, including NKX070 (targeting CD70) and a novel NK+T cell therapy[25](index=25&type=chunk)[81](index=81&type=chunk) - Nkarta is constructing an **88,000 square foot facility** in South San Francisco to support pivotal clinical trials and potential commercial supply, which will also serve as its future headquarters[33](index=33&type=chunk) [Our Pipeline and Technology](index=6&type=section&id=Our%20Pipeline%20and%20Technology) Nkarta's pipeline leverages a modular NK cell engineering platform, advancing lead candidates NKX101 and NKX019, and includes a collaboration with CRISPR Therapeutics for gene-edited NK cell therapies Nkarta's Product Pipeline (as of Dec 31, 2022) | Product Candidate | Target | Indication | Development Stage | | :--- | :--- | :--- | :--- | | **NKX101** | NKG2D-CAR | r/r AML / MDS | Phase 1 | | **NKX019** | CD19-CAR | B-Cell Malignancies | Phase 1 | | **NKX070** | CD70-CAR | Solid & Liquid Tumors | Preclinical (with CRISPR) | | **NK+T** | Undisclosed | Cancer | Discovery (with CRISPR) | - The NK cell engineering platform is designed to enhance expansion, persistence (using membrane-bound IL-15), targeting, and cytotoxicity of NK cells, and enables cryopreservation for off-the-shelf use[50](index=50&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - In a Phase 1 trial for NKX101, **3 of 5 r/r AML patients (60%)** at higher dose levels achieved a complete response (CR) with hematologic recovery as of April 2022[70](index=70&type=chunk) - In a Phase 1 trial for NKX019, **7 of 10 patients (70%)** with B-cell malignancies at higher dose levels achieved a complete response (CR) as of December 2022[78](index=78&type=chunk) [Manufacturing](index=22&type=section&id=Manufacturing) Nkarta emphasizes internal cGMP manufacturing, operating a clinical facility and constructing a larger commercial-scale facility for high-yield, off-the-shelf NK cell therapy production - The company operates a **2,700-square foot clinical cGMP facility** in South San Francisco, currently manufacturing NKX019 and planned for NKX101 in 2023[26](index=26&type=chunk)[32](index=32&type=chunk)[88](index=88&type=chunk) - A new **88,000 square foot facility** is under construction to support pivotal trials and potential commercial supply[33](index=33&type=chunk)[89](index=89&type=chunk) - The manufacturing process involves isolating NK cells from healthy donors, expansion using proprietary NKSTIM cells, genetic engineering via gamma-retrovirus, and cryopreservation for an off-the-shelf product[83](index=83&type=chunk)[87](index=87&type=chunk) - The company believes its optimized process could allow the production of **several thousand doses** from a single manufacturing run[52](index=52&type=chunk)[90](index=90&type=chunk) [Intellectual Property](index=24&type=section&id=Intellectual%20Property) Nkarta's IP strategy combines owned and in-licensed patents, trademarks, and trade secrets, with a portfolio of **at least 20 issued patents and 130 pending applications** as of 2022, including a key exclusive license from NUS and St. Jude - As of December 31, 2022, Nkarta's patent portfolio includes **at least 20 issued utility patents** and **at least 130 pending utility patent applications**, which are solely owned, jointly owned, or licensed[93](index=93&type=chunk) - The company has an exclusive, worldwide license agreement with National University of Singapore (NUS) and St. Jude Children's Research Hospital for key NK cell technology, with the last patent rights expected to expire around **2039**[98](index=98&type=chunk)[317](index=317&type=chunk) - Patents related to NKX101, NKX019, and NKX070 cover composition of matter, manufacturing processes, and methods of use, with estimated expirations for the portfolio extending to **2043**[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk) [Government Regulation and Competition](index=26&type=section&id=Government%20Regulation%20and%20Competition) Nkarta operates in a highly regulated environment under FDA oversight, navigating complex approval processes and intense competition from large biopharmaceutical companies and specialized cell therapy firms - The company's products are regulated as biologics by the FDA, requiring an extensive process of preclinical studies and clinical trials under an IND before a Biologics License Application (BLA) can be submitted for marketing approval[103](index=103&type=chunk)[105](index=105&type=chunk) - The FDA granted orphan drug designation to NKX101 for the treatment of AML in December 2021, which may provide **seven years of market exclusivity** upon approval[134](index=134&type=chunk)[248](index=248&type=chunk) - Key competitors in allogeneic cell therapy include 2seventy Bio, Allogene, Bristol-Myers Squibb, CRISPR Therapeutics, Fate Therapeutics, and Gilead; approved autologous CAR-T therapies are direct competitors to NKX019[177](index=177&type=chunk) - The company is subject to healthcare laws such as the Anti-Kickback Statute and the False Claims Act, and must comply with pricing, reimbursement, and healthcare reform measures like the Inflation Reduction Act of 2022[157](index=157&type=chunk)[158](index=158&type=chunk)[169](index=169&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, clinical, manufacturing, IP, and commercialization risks due to its limited operating history, novel CAR NK cell technology, and intense competition - Financial Risks: The company has a history of significant losses (**$113.8 million** in 2022) and expects them to continue, requiring additional capital which may not be available or could cause dilution[190](index=190&type=chunk)[197](index=197&type=chunk) - Clinical & Development Risks: The business is highly dependent on the success of its CAR NK platform and lead candidates NKX101 and NKX019; clinical development is lengthy, expensive, and uncertain, with early-stage results not necessarily predictive of future success[207](index=207&type=chunk)[216](index=216&type=chunk)[222](index=222&type=chunk) - Manufacturing Risks: The manufacturing process for cell therapies is novel and complex, potentially leading to difficulties in production, scaling up, and consistency, with reliance on a sole supplier for certain critical components[289](index=289&type=chunk)[304](index=304&type=chunk) - Intellectual Property Risks: The company relies on a key license agreement with NUS and St. Jude, whose termination could cause loss of rights to core technology, and patent protection may not be sufficiently robust to prevent competition[317](index=317&type=chunk)[332](index=332&type=chunk) - Commercialization & Competition Risks: The company faces intense competition, and the commercial success of its products, if approved, will depend on uncertain market acceptance, pricing, and reimbursement[272](index=272&type=chunk)[377](index=377&type=chunk)[380](index=380&type=chunk) [Unresolved Staff Comments](index=94&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[443](index=443&type=chunk) [Properties](index=94&type=section&id=Item%202.%20Properties) Nkarta leases **42,145 square feet** of office, lab, and clinical manufacturing space in South San Francisco, and is constructing an **88,000 square foot facility** for future headquarters and commercial manufacturing - The company leases approximately **42,145 sq. ft.** of office, lab, and manufacturing space in South San Francisco, CA[444](index=444&type=chunk) - An **88,000 sq. ft. facility** is being built out in South San Francisco to serve as the future headquarters and for commercial-scale manufacturing, with a lease expiring in **2034**[444](index=444&type=chunk) [Legal Proceedings](index=94&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in material legal proceedings, though past ex parte reexaminations against licensed patents concluded with claims maintained in an amended form unrelated to current product candidates - There are no pending claims or actions likely to have a material adverse effect on the business[446](index=446&type=chunk) - Ex parte reexaminations against three licensed patents were concluded, with claims maintained in an amended form not related to current product candidates[447](index=447&type=chunk) [Mine Safety Disclosures](index=94&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[448](index=448&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=95&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Nkarta's common stock trades on The Nasdaq Global Select Market under the symbol "NKTX", with no history or future plans for cash dividends, and no material change in IPO proceeds use - The company's common stock trades on The Nasdaq Global Select Market under the symbol **"NKTX"**[450](index=450&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[452](index=452&type=chunk) - There has been no material change in the planned use of proceeds from the July 2020 IPO[454](index=454&type=chunk) [Reserved]](index=96&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=97&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2022, Nkarta reported a net loss of **$113.8 million**, an increase from 2021, driven by higher R&D and G&A expenses, ending the year with **$354.9 million** in cash and investments, deemed sufficient for the next 12 months Results of Operations (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $90,897 | $63,412 | $27,485 | | General and administrative | $28,058 | $23,017 | $5,041 | | **Total operating expenses** | **$118,955** | **$86,429** | **$32,526** | | Loss from operations | ($118,955) | ($86,429) | ($32,526) | | Interest income | $5,588 | $370 | $5,218 | | **Net loss** | **($113,837)** | **($86,075)** | **($27,762)** | - R&D expenses increased by **$27.5 million** in 2022, driven by a **$13.4 million** increase in external program costs for NKX101 and NKX019, a **$4.7 million** increase in personnel costs, and an **$11.2 million** increase in other internal research costs[495](index=495&type=chunk) - G&A expenses increased by **$5.1 million** in 2022, primarily due to a **$3.4 million** increase in personnel costs and a **$1.0 million** increase in professional services fees[496](index=496&type=chunk) - As of December 31, 2022, the company had **$354.9 million** in cash, cash equivalents, restricted cash, and short-term investments; management believes this is sufficient to fund operations for at least the next 12 months[467](index=467&type=chunk)[504](index=504&type=chunk) Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($57,000) | ($67,927) | | Net cash provided by (used in) investing activities | ($184,689) | $32,534 | | Net cash provided by financing activities | $219,012 | $1,202 | [Quantitative and Qualitative Disclosures About Market Risk](index=108&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuation on investments, with a **10% change** not expected to be material, alongside foreign currency exposure and inflation impacts on costs - The primary market risk is interest rate fluctuation on cash, cash equivalents, and short-term investments; a **10% change** in interest rates is not expected to have a material impact[534](index=534&type=chunk) - The company is exposed to foreign currency exchange risk through contracts with vendors outside the U.S. but does not currently hedge this risk[535](index=535&type=chunk) - Inflation affects labor and R&D costs but is not believed to have had a material effect on results of operations during the reported periods[535](index=535&type=chunk) [Financial Statements and Supplementary Data](index=109&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for 2022 and 2021 show a net loss of **$113.8 million** in 2022, with total assets increasing to **$472.9 million** and total liabilities to **$100.7 million**, primarily due to a stock offering and new facility lease liabilities [Balance Sheets](index=111&type=section&id=Balance%20Sheets) As of December 31, 2022, Nkarta's total assets increased to **$472.9 million**, driven by cash and investments, while total liabilities rose to **$100.7 million** due to operating lease liabilities, and stockholders' equity grew to **$372.2 million** Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents & short-term investments | $352,143 | $238,088 | | Total current assets | $360,688 | $245,780 | | Property and equipment, net | $61,908 | $12,856 | | **Total assets** | **$472,938** | **$273,903** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $22,046 | $12,943 | | Operating lease liabilities, non-current | $78,685 | $9,975 | | **Total liabilities** | **$100,731** | **$22,936** | | **Total stockholders' equity** | **$372,207** | **$250,967** | [Statements of Operations and Comprehensive Loss](index=112&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) For 2022, Nkarta reported a net loss of **$113.8 million** or **($2.61) per share**, an increase from 2021, primarily due to higher operating expenses driven by increased R&D activities, partially offset by higher interest income Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Research and development | $90,897 | $63,412 | | General and administrative | $28,058 | $23,017 | | **Total operating expenses** | **$118,955** | **$86,429** | | **Loss from operations** | **($118,955)** | **($86,429)** | | Interest income | $5,588 | $370 | | **Net loss** | **($113,837)** | **($86,075)** | | Net loss per share, basic and diluted | ($2.61) | ($2.62) | [Statements of Cash Flows](index=114&type=section&id=Statements%20of%20Cash%20Flows) For 2022, net cash used in operating activities was **$57.0 million**, net cash used in investing activities was **$184.7 million**, and net cash provided by financing activities was **$219.0 million** from a stock offering, resulting in a net decrease in cash of **$22.7 million** Cash Flow Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($57,000) | ($67,927) | | Net cash provided by (used in) investing activities | ($184,689) | $32,534 | | Net cash provided by financing activities | $219,012 | $1,202 | | **Net decrease in cash and cash equivalents** | **($22,677)** | **($34,191)** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=133&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting principles, practices, or financial statement disclosure - None[654](index=654&type=chunk) [Controls and Procedures](index=133&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022, with no material changes during the fourth quarter - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[656](index=656&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[658](index=658&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[659](index=659&type=chunk) [Other Information](index=134&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[663](index=663&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=134&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - None[664](index=664&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=135&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders - The required information is incorporated by reference from the registrant's Definitive Proxy Statement for the 2023 Annual Meeting of Stockholders[7](index=7&type=chunk)[668](index=668&type=chunk) [Executive Compensation](index=135&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders - The required information is incorporated by reference from the registrant's Definitive Proxy Statement for the 2023 Annual Meeting of Stockholders[7](index=7&type=chunk)[669](index=669&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=135&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders - The required information is incorporated by reference from the registrant's Definitive Proxy Statement for the 2023 Annual Meeting of Stockholders[7](index=7&type=chunk)[670](index=670&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=135&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders - The required information is incorporated by reference from the registrant's Definitive Proxy Statement for the 2023 Annual Meeting of Stockholders[7](index=7&type=chunk)[671](index=671&type=chunk) [Principal Accountant Fees and Services](index=135&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting of Stockholders - The required information is incorporated by reference from the registrant's Definitive Proxy Statement for the 2023 Annual Meeting of Stockholders[7](index=7&type=chunk)[672](index=672&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=136&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Form 10-K, including financial statements and a detailed list of exhibits, with all financial statement schedules omitted as not applicable or included elsewhere - The financial statements are filed as part of the report; all financial statement schedules are omitted because they are not applicable or the information is included in the financial statements[676](index=676&type=chunk) - A list of exhibits, including governance documents, material contracts, and certifications, is provided, indicating which are filed herewith and which are incorporated by reference[678](index=678&type=chunk) [Form 10-K Summary](index=139&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no summary for this item - None[682](index=682&type=chunk)
Nkarta(NKTX) - 2022 Q3 - Quarterly Report
2022-11-09 21:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39370 Nkarta, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 47-4515206 (State or other jurisdiction of ...
Nkarta(NKTX) - 2022 Q2 - Quarterly Report
2022-08-11 20:20
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited statements show increased assets from a stock offering but a growing net loss due to higher R&D expenses [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) Total assets grew to $503.6 million, driven by a stock offering, while liabilities and stockholders' equity also increased Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $131,646 | $60,816 | | Short-term investments | $281,305 | $177,272 | | Total current assets | $417,379 | $245,780 | | Total assets | $503,641 | $273,903 | | **Liabilities & Stockholders' Equity** | | | | Total liabilities | $82,600 | $22,936 | | Total stockholders' equity | $421,041 | $250,967 | | Accumulated deficit | $(257,006) | $(204,096) | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a higher net loss of $52.9 million for the first half of 2022, driven by increased R&D and G&A expenses Statement of Operations Summary (in thousands) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Research and development | $40,617 | $29,496 | | General and administrative | $13,093 | $11,618 | | Total operating expenses | $53,710 | $41,114 | | Loss from operations | $(53,710) | $(41,114) | | Net loss | $(52,910) | $(40,908) | | Net loss per share, basic and diluted | $(1.38) | $(1.25) | [Condensed Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity rose to $421.0 million, primarily due to $215.3 million in net proceeds from a secondary stock offering - In Q2 2022, the company completed a secondary offering, issuing 15,333,334 shares of common stock, which resulted in **net proceeds of approximately $215.3 million**[22](index=22&type=chunk) - **Share-based compensation expense** for the six months ended June 30, 2022, was **$8.0 million**[22](index=22&type=chunk)[71](index=71&type=chunk) [Condensed Statement of Cash Flows](index=11&type=section&id=Condensed%20Statement%20of%20Cash%20Flows) Financing activities provided $216.0 million in cash, offsetting cash used in operations and investments for a net cash increase Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,872) | $(32,099) | | Net cash used in investing activities | $(110,322) | $(41,145) | | Net cash provided by financing activities | $216,024 | $1,012 | | Net increase (decrease) in cash | $70,830 | $(72,232) | - The company received **$215.6 million in net proceeds** from its secondary offering during the six months ended June 30, 2022[27](index=27&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's biopharmaceutical business, liquidity position, accounting policies, and key collaborations - The company is a biopharmaceutical company focused on developing **engineered natural killer (NK) cells** to treat cancer[30](index=30&type=chunk) - As of June 30, 2022, the company had an **accumulated deficit of $257.0 million** and cash, cash equivalents, restricted cash and short-term investments of **$415.0 million**[31](index=31&type=chunk) - On April 28, 2022, the company raised approximately **$215.3 million in net proceeds** from a secondary offering of common stock[33](index=33&type=chunk) - In May 2021, the company entered into a research collaboration with CRISPR Therapeutics to **co-develop and co-commercialize engineered CAR-NK product candidates**, sharing R&D costs and potential profits[61](index=61&type=chunk)[62](index=62&type=chunk) - In August 2022, the company amended lease agreements, securing an **additional $15.0 million in tenant improvement allowances** and extending lease terms[73](index=73&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its clinical-stage NK cell therapy development, rising expenses, recent financing, and operational risks - The company's co-lead product candidates, **NKX101 and NKX019**, are in ongoing Phase 1 clinical trials for treating various cancers[75](index=75&type=chunk) - The company has incurred a **net loss of $52.9 million** for the six months ended June 30, 2022, and expects to continue incurring significant losses[80](index=80&type=chunk) - In April 2022, a secondary offering provided **net proceeds of approximately $215.3 million**[83](index=83&type=chunk) - Management believes that current cash, cash equivalents, and investments of **$415.0 million** (as of June 30, 2022) are sufficient to fund operations for at least the next 12 months[113](index=113&type=chunk) - The company is monitoring impacts from COVID-19 and macroeconomic conditions, noting disruptions in clinical trial enrollment, supply chain shortages, and **inflation affecting construction costs** for its new facility[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating expenses increased to $53.7 million due to higher personnel and program costs for clinical candidates NKX101 and NKX019 Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $40,617 | $29,496 | $11,121 | | General and administrative | $13,093 | $11,618 | $1,475 | | Total operating expenses | $53,710 | $41,114 | $12,596 | | Net loss | $(52,910) | $(40,908) | $(12,002) | - The increase in R&D expenses was primarily due to a **$2.7 million increase in personnel costs**, a **$5.9 million increase in program costs** for NKX101 and NKX019, and a **$4.4 million increase in other internal research costs**[100](index=100&type=chunk) - The increase in G&A expenses was mainly due to a **$1.5 million increase in personnel costs** and a **$0.7 million increase in other administrative expenses** like insurance and rent[104](index=104&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity was significantly boosted by a $215.3 million secondary offering, ensuring sufficient capital for over 12 months - The company had **$415.0 million in cash, cash equivalents, restricted cash, and short-term investments** as of June 30, 2022[108](index=108&type=chunk) - A secondary offering in April 2022 provided **net proceeds of approximately $215.3 million**[110](index=110&type=chunk) - The company believes its existing cash and investments are **sufficient to fund operations for at least the next 12 months** from the filing date of the report[118](index=118&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | | :--- | :--- | | Net cash used in operating activities | $(34,872) | | Net cash used in investing activities | $(110,322) | | Net cash provided by financing activities | $216,024 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to interest rate risk on its investment portfolio and foreign currency risk from vendor contracts - The company's primary market risk is **interest rate risk** on its portfolio of cash, cash equivalents, and short-term investments[136](index=136&type=chunk) - The company is exposed to **foreign currency exchange risk** through contracts with non-U.S. vendors but does not currently use hedging instruments[137](index=137&type=chunk) - **Inflation affects labor and R&D costs**, but management does not believe it has had a material effect on results of operations during the periods presented[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period - Management concluded that as of June 30, 2022, the company's **disclosure controls and procedures were effective** at a reasonable assurance level[139](index=139&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the quarter ended June 30, 2022[140](index=140&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in material legal proceedings but faces reexaminations of licensed patents related to its NKX101 candidate - The company states there are **no pending claims or actions** likely to have a material adverse effect on its business[143](index=143&type=chunk) - Third parties have filed for ***ex parte* reexaminations** against certain licensed patents related to the NKX101 product candidate (U.S. Patent Nos. 10,774,309 and 10,829,737), which are currently pending[144](index=144&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from its history of losses, dependence on novel cell therapies, and need for future capital - The company has a limited operating history, has incurred significant losses since inception (**accumulated deficit of $257.0 million** as of June 30, 2022), and expects to continue incurring losses[147](index=147&type=chunk)[148](index=148&type=chunk) - The business is **highly dependent on the success of its CAR-NK cell technology platform** and its lead product candidates, NKX101 and NKX019, which are in early-stage clinical trials[169](index=169&type=chunk)[183](index=183&type=chunk) - The manufacturing process for the company's cell therapies is **novel, complex, and susceptible to production difficulties**, which could delay clinical trials and commercialization[236](index=236&type=chunk) - The company faces risks related to its intellectual property, including potential termination of a key license agreement and **ongoing patent challenges**[261](index=261&type=chunk)[280](index=280&type=chunk) - Macroeconomic conditions, including **rising inflation and supply chain constraints**, are affecting business operations, particularly the cost and timeline for constructing its manufacturing facility[361](index=361&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity and details the use of $72.8 million from its 2020 IPO proceeds - **No unregistered sales of equity securities** occurred during the quarter[376](index=376&type=chunk) - As of June 30, 2022, the company has used **$72.8 million of its IPO proceeds** for R&D, manufacturing facility construction, and working capital[378](index=378&type=chunk) [Item 3. Defaults Upon Senior Securities](index=74&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[380](index=380&type=chunk) [Item 4. Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[381](index=381&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company amended lease agreements to increase tenant improvement allowances and announced the resignation of a director - On August 11, 2022, the company amended its lease agreements, increasing the **tenant improvement allowance by $15 million** in exchange for higher rent and an extended lease term for some facilities[383](index=383&type=chunk) - Director Tiba Aynechi **resigned from the Board of Directors**, effective August 15, 2022, for reasons not related to any disagreement with the company[385](index=385&type=chunk) [Item 6. Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including lease amendments and officer certifications