Nkarta Inc

Previous wording

We are a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf engineered NK-cell therapies for the treatment of patients with autoimmune diseases or hematologic malignancies. We are currently developing NKX019, a CAR NK product candidate targeting the CD19 antigen, as our lead product candidate. We have also been developing NKX101, a CAR NK-cell product candidate targeting cells that display NKG2D ligands. Both product candidates enable an on-demand, off-the-shelf approach involving scaled manufacturing to broaden patient access. NKX019 and NKX101 incorporate proprietary technologies that enable us to generate an abundant supply of NK cells, increase NK-cell recognition of target antigens, enhance NK-cell fitness and freeze, store, and thaw our engineered NK cells for off-the-shelf administration. Our product candidates are allogeneic, which means they are produced using cells from a different person than the patient(s) being treated, and they are produced in quantity, then frozen and therefore available for treating patients without delay, unlike autologous cell therapies, which are derived from a patient’s own cells and must be manufactured as needed for each patient. We believe that engineered NK cells have the potential to be effective and accessible therapies for autoimmune diseases and cancer, be well tolerated, and avoid some of the toxicities observed with other cell therapies.

Current wording

We are a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf engineered NK-cell therapies. We are currently developing NKX019, a CAR NK product candidate targeting the CD19 antigen, as our lead product candidate for the treatment of patients with autoimmune disease. NKX019 and our other CAR NK product candidates incorporate proprietary technologies that enable us to generate an abundant supply of NK cells, increase NK-cell recognition of target antigens, enhance NK-cell fitness and freeze, store, and thaw our engineered NK cells for off-the-shelf administration. Our product candidates are allogeneic, which means they are produced using cells from a different person than the patient(s) being treated, and they are produced in quantity, then frozen and therefore available for treating patients without delay, unlike autologous cell therapies, which are derived from a patient’s own cells and must be manufactured as needed for each patient. We believe that engineered NK cells have the potential to be effective and accessible therapies for autoimmune diseases and other diseases, be well tolerated, and avoid some of the toxicities observed with other cell therapies.

Previous wording

In June 2024, we announced the initiation of Ntrust-1, a multi-center, open-label, dose-escalation Phase 1 clinical trial of NKX019 for lupus nephritis (“LN”). At that time, we also announced that we had received clearance of an Investigational New Drug ("IND") application by the United States Food and Drug Administration ("FDA") to evaluate NKX019 for the treatment of additional autoimmune diseases. Ntrust-2 is a planned multi-center, open-label, dose-escalation Phase 1 clinical trial that will evaluate the safety and clinical activity of NKX019 in humans with systemic sclerosis ("scleroderma"), idiopathic inflammatory myopathy ("myositis") and antineutrophil cytoplasmic antibody ("ANCA")-associated vasculitis ("AAV"). In July 2024, we announced that researchers at Columbia University Irving Medical Center (“CUIMC”) initiated an investigator-sponsored trial (“IST”) of NKX019 in patients with systemic lupus erythematosus (“SLE”). NKX019 is also being studied in a multi-center Phase 1 clinical trial for the treatment of a variety of B-cell malignancies, which evaluates the safety, pharmacology, and preliminary anti-tumor activity of NKX019.

Current wording

In June 2024, we announced the initiation of Ntrust-1, a multi-center, open-label, dose-escalation Phase 1 clinical trial of NKX019 for lupus nephritis (“LN”). At that time, we also announced that we had received clearance of an Investigational New Drug ("IND") application by the United States Food and Drug Administration ("FDA") to evaluate NKX019 for the treatment of additional autoimmune diseases. Ntrust-2 is a planned multi-center, open-label, dose-escalation Phase 1 clinical trial that will evaluate the safety and clinical activity of NKX019 in humans with systemic sclerosis ("scleroderma"), idiopathic inflammatory myopathy ("myositis") and antineutrophil cytoplasmic antibody ("ANCA")-associated vasculitis ("AAV"). In July 2024, we announced that researchers at Columbia University Irving Medical Center (“CUIMC”) initiated an investigator-sponsored trial (“IST”) of NKX019 in patients with systemic lupus erythematosus (“SLE”). In November 2024, we announced that the first patient was dosed in both Ntrust-1 and the IST at CUIMC.

Previous wording

NKX101 has been evaluated in a multi-center Phase 1 clinical trial in the U.S. for the treatment of relapsed or refractory acute myeloid leukemia ("r/r AML") and higher risk myelodysplastic syndromes ("MDS"). This first-in-human study evaluated the safety, pharmacology, and preliminary anti-tumor activity of NKX101. We have deprioritized the development of NKX101 as part of a realignment of our pipeline to direct primary resources to development of our lead product candidate, NKX019, for the treatment of autoimmune diseases.

Current wording

NKX101, our CAR NK-cell product candidate targeting cells that display NKG2D ligands, has been evaluated in a multi-center Phase 1 clinical trial in the U.S. for the treatment of relapsed or refractory acute myeloid leukemia ("r/r AML") and higher risk myelodysplastic syndromes ("MDS"). This first-in-human study evaluated the safety, pharmacology, and preliminary anti-tumor activity of NKX101. We have deprioritized further development of NKX101 to direct primary resources to development of our lead product candidate, NKX019, for the treatment of autoimmune diseases.

Previous wording

Company stock and intend to raise additional capital to fund operations until such time that we are able to generate sufficient revenues to cover our operating expenses. We may seek additional funding through the issuance of common stock, including through our ATM Offering Program, other equity or debt financing or collaborations or partnerships with other companies. The amount and timing of our future funding requirements will depend on many factors, including, among other things, the pace and results of our clinical development efforts for our product candidates. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital as and when needed would compromise our ability to execute our business plan and may cause us to undertake further cost containment measures and/or significantly delay, scale back or discontinue the development of some of our programs. We have also incurred increased operating expenses since becoming a public company, which we expect will further increase when we are no longer able to rely on certain “emerging growth company” exemptions we are afforded under the Jumpstart Our Business Startups Act (the "JOBS Act") as further described under “—JOBS Act” below. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.

Current wording

Since the commencement of our operations in 2015, we have devoted substantially all our resources in support of our product development efforts, hiring personnel, raising capital to support and expand such activities and providing general and administrative support for these operations. We have incurred net operating losses since inception and have not generated any revenue from product sales. In the future, we expect that our operating expenses will significantly increase as we continue to develop and seek regulatory approvals for our product candidates, continue to engage in other research and development activities to expand our pipeline of product candidates, maintain and expand our intellectual property portfolio, maintain and expand our product manufacturing capabilities, and ultimately establish a commercial organization. We have funded our operations primarily through the issuance of Company stock and intend to raise additional capital to fund operations until such time that we are able to generate sufficient revenues to cover our operating expenses. We may seek additional funding through the issuance of common stock, including through equity or debt financing or collaborations or partnerships with other companies. The amount and timing of our future funding requirements will depend on many factors, including, among other things, the pace and results of our clinical development efforts for our product candidates. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital as and when needed would compromise our ability to execute our business plan and may cause us to undertake cost containment measures and/or significantly delay, scale back or discontinue the development of some of our programs. We have also incurred increased operating expenses since becoming a public company, which we expect will further increase when we are no longer able to rely on certain “emerging growth company” exemptions we are afforded under the Jumpstart Our Business Startups Act (the "JOBS Act") as further described under “—JOBS Act” below. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2024 and 2023. The direct external development program expenses reflect external costs attributable to our clinical development candidates and preclinical candidates selected for further development. Such expenses include third-party contract costs relating to manufacturing, clinical trial activities, translational medicine and toxicology activities. The unallocated internal research and development costs include personnel, facility costs, laboratory consumables and discovery and research related activities associated with our pipeline. The partner cost sharing represents reimbursable research and development expenses from the CRISPR Agreement.

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2024 and 2023. The direct external development program expenses reflect external costs attributable to our clinical development candidates and preclinical candidates selected for further development. Such expenses include third-party contract costs relating to manufacturing, clinical trial activities, translational medicine and toxicology activities. The unallocated internal research and development costs include personnel, facility costs, laboratory consumables and discovery and research related activities associated with our pipeline. The partner cost sharing represents reimbursable research and development expenses from the CRISPR Agreement.

Previous wording

While we continue to pursue cost containment measures, we still expect our general and administrative expenses will increase in the future in support of increased research and development activities and to reflect increased costs associated with operating as a public company. These anticipated increased costs will include increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, insurance premiums and investor relations costs.

Current wording

While we continue to closely manage our expenditures, we still expect our general and administrative expenses will increase in the future in support of increased research and development activities and to reflect increased costs associated with operating as a public company. These anticipated increased costs will include increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, insurance premiums and investor relations costs.

Previous wording

Research and development expenses. Research and development expenses were $23.1 million and $25.1 million for the three months ended June 30, 2024 and 2023, respectively. Research and development expenses were $48.4 million and $51.3 million for the six months ended June 30, 2024 and 2023, respectively.

Current wording

Research and development expenses. Research and development expenses were $25.3 million and $22.2 million for the three months ended September 30, 2024 and 2023, respectively. Research and development expenses were $73.6 million and $73.5 million for the nine months ended September 30, 2024 and 2023, respectively.

Previous wording

a $1.2 million increase in depreciation expense due to the timing of when assets were placed in-service in 2023; and

Current wording

a $0.3 million increase in depreciation expense due to the timing of when assets were placed in-service during the year in 2023; and

Previous wording

a $0.7 million net decrease in other research costs, primarily consisting of payroll, facility allocation expenses, offset by partner cost sharing reimbursable expenses.

Current wording

a $1.5 million net increase in other research costs, primarily consisting of facility allocation expenses, which was partially offset by partner cost sharing reimbursable expenses and a decrease in payroll expenses.

Previous wording

a $2.5 million increase in depreciation expense due to the timing of when assets were placed in-service in 2023;

Current wording

a $2.8 million increase in depreciation expense due to the timing of when assets were placed in-service during the year in 2023;

Previous wording

a $1.1 million decrease in partner cost sharing reimbursable expenses related to a decrease in activities performed under our collaboration with CRISPR; and

Current wording

a $1.3 million decrease in partner cost sharing reimbursable expenses related to a decrease in activities performed under our collaboration with CRISPR;

Previous wording

a $1.0 million net increase in other research costs, primarily consisting of an increase in supplies purchased, and offset by a decrease in payroll and facility allocation expenses.

Current wording

a $1.3 million net increase in other research costs, primarily consisting of consulting expenses, which was partially offset by a decrease in payroll and facility expenses due to the reallocation of the Sublease Asset Group to general and administrative expenses; and

Previous wording

General and administrative expenses. General and administrative expenses were $7.6 million and $15.1 million for the three and six months ended June 30, 2024, respectively, and $11.7 million and $19.9 million for the three and six months ended June 30, 2023, respectively.

Current wording

General and administrative expenses. General and administrative expenses were $8.5 million and $23.7 million for the three and nine months ended September 30, 2024, respectively, and $7.1 million and $27.0 million for the three and nine months ended September 30, 2023, respectively.

Previous wording

The decrease of $4.2 million and $4.8 million the three and six months ended June 30, 2024, respectively, were primarily due to the $4.1 million impairment of the right-of-use assets during the three months ended June 30, 2023 and a decrease in personnel-related expenses resulting from reduced headcount following the reduction in force completed in October 2023, partially offset by an increase in depreciation.

Current wording

The increase of $1.4 million for the three months ended September 30, 2024 was primarily due to an increase in depreciation, personnel-related expenses, and consulting expenses. The decrease of $3.4 million for the nine months ended September 30, 2024 was primarily due to the $4.1 million impairment of the right-of-use assets during the nine months ended September 30, 2023 and a decrease in personnel-related expenses for the nine months ended September 30, 2024 resulting from the reduction in force completed in October 2023, partially offset by an increase in depreciation.

Previous wording

Interest income. Interest income was $5.7 million and $9.0 million for the three and six months ended June 30, 2024, respectively, and $3.6 million and $7.0 million for the three and six months ended June 30, 2023, respectively. The increase of $2.2 million and $1.9 million for the three and six months ended June 30, 2024, respectively, were primarily due to higher average investment balances in the current period. Interest income includes interest earned from investments, partially offset by amortization of purchase premiums and accretion of discounts of investments.

Current wording

Interest income. Interest income was $5.5 million and $14.4 million for the three and nine months ended September 30, 2024, respectively, and $3.6 million and $10.7 million for the three and nine months ended September 30, 2023, respectively. The increase of $1.8 million and $3.8 million for the three and nine months ended September 30, 2024, respectively, were primarily due to higher average investment balances and higher yields in the current period. Interest income includes interest earned from investments, partially offset by amortization of purchase premiums and accretion of discounts of investments.

Previous wording

As of June 30, 2024, we had cash, cash equivalents, restricted cash and investments of $426.7 million. We estimate that all $265.1 million in net proceeds from our July 2020 initial public offering have been spent. On April 28, 2022, we received $215.3 million in net proceeds, after deducting underwriting discounts, commissions and other offering expenses, in connection with our secondary offering of our common stock. On March 27, 2024, we received $225.1 million in net proceeds from an underwritten public offering, after deducting underwriting discounts, commissions and expenses, described further below.

Current wording

As of September 30, 2024, we had cash, cash equivalents, restricted cash and investments of $405.3 million. We estimate that all $265.1 million in net proceeds from our July 2020 initial public offering have been spent. On April 28, 2022, we received $215.3 million in net proceeds, after deducting underwriting discounts, commissions and other offering expenses, in connection with our secondary offering of our common stock. On March 27, 2024, we received $225.1 million in net proceeds from an underwritten public offering, after deducting underwriting discounts, commissions and expenses, described further below.

Previous wording

On August 12, 2021, the Company entered into a sales agreement with Cowen and Company, LLC, as sales agent, to provide for the offering, issuance and sale of up to an aggregate of $150.0 million of the Company’s common stock through an “at-the-market” equity offering program (the "ATM Offering Program") pursuant to the Prior Registration Statement and subject to the limitations thereof. For the six months ended June 30, 2024, no sales of the Company’s common stock were made pursuant to the ATM Offering Program.

Current wording

Effective August 27, 2024, the Company and Cowen and Company, LLC mutually terminated the sales agreement entered into on August 12, 2021 related to the Company’s $150.0 million “at-the-market” equity offering program, pursuant to the terms of the sales agreement. Prior to the termination of the sales agreement, $1.8 million of shares of common stock had been sold.

Previous wording

We have incurred net losses and negative cash flows from operations since our inception. As of June 30, 2024, we had an accumulated deficit of $489.9 million and anticipate that we will continue to incur net losses for the foreseeable future. We expect to incur substantial expenditures as we develop our product pipeline and advance our drug candidates through clinical development, undergo the regulatory approval process and, if approved, launch commercial activities. Specifically, in the near term we expect to incur substantial expenses relating to initiating and completing our clinical trials, the development and validation of our manufacturing processes, and other development activities.

Current wording

We have incurred net losses and negative cash flows from operations since our inception. As of September 30, 2024, we had an accumulated deficit of $518.3 million and anticipate that we will continue to incur net losses for the foreseeable future. We expect to incur substantial expenditures as we develop our product pipeline and advance our drug candidates through clinical development, undergo the regulatory approval process and, if approved, launch commercial activities. Specifically, in the near term we expect to incur substantial expenses relating to initiating and completing our clinical trials, the development and validation of our manufacturing processes, and other development activities.

Previous wording

We will need substantial additional funding to support our continuing operations and pursue our long-term development strategy, including the potential initiation of a pivotal stage clinical trial for any or all of our current development programs. Until such time as we can generate significant revenue from sales of our drug candidates, if ever, we may seek additional funding through the issuance of our common stock, including through our ATM Offering Program, other equity or debt financing or collaborations or partnerships with other companies. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts for our product candidates and other research, development and manufacturing activities, market conditions, and the success of our planned cost-containment measures. We may not be able to raise additional capital on terms acceptable to us, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of our drug candidates or delay our efforts to expand our product pipeline. We may also be required to sell or license to other parties’ rights to develop or commercialize our drug candidates that we would prefer to retain.

Current wording

We will need substantial additional funding to support our continuing operations and pursue our long-term development strategy, including the potential initiation of a pivotal stage clinical trial for any or all of our current development programs. Until such time as we can generate significant revenue from sales of our drug candidates, if ever, we may seek additional funding through the issuance of our common stock, including through equity or debt financing or collaborations or partnerships with other companies. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts for our product candidates and other research, development and manufacturing activities, market conditions, and the success of our planned cost-containment measures. We may not be able to raise additional capital on terms acceptable to us, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of our drug candidates or delay our efforts to expand our product pipeline. We may also be required to sell or license to other parties’ rights to develop or commercialize our drug candidates that we would prefer to retain.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $50.4 million primarily due to a net loss of $54.5 million adjusted for a decrease in net change in operating assets and liabilities of $7.3 million, which was offset by an increase in net of non-cash charges of $11.4 million. The change in net operating assets and liabilities was primarily due to an increase in interest receivable and prepaid expenses for the maintenance of labratory equipment, and a decrease in accruals and operating lease liability. The non-cash charges primarily consisted of stock-based compensation of $8.8 million, depreciation and amortization of $4.5 million, which was offset by investment accretion and amortization of $3.0 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $74.9 million primarily due to a net loss of $82.9 million adjusted for a decrease in net change in operating assets and liabilities of $8.5 million, which was offset by an increase in net of non-cash charges of $16.4 million. The change in net operating assets and liabilities was primarily due to an increase in prepaid expenses for the maintenance of laboratory equipment, interest receivable, and accruals, and a decrease in accounts payable and operating lease liability. The non-cash charges primarily consisted of stock-based compensation of $12.8 million, depreciation and amortization of $6.9 million, which was offset by investment accretion and amortization of $5.0 million.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2023 was $42.5 million, primarily due to a net loss of $64.1 million adjusted for net change in operating assets and liabilities of $9.9 million, and net of non-cash charges of $11.7 million. The change in net operating assets and liabilities was primarily due operating lease liabilities of $7.1 million from tenant improvement allowance reimbursements and an increase in accounts payable of $1.2 million.. The non-cash charges primarily consistent of stock-based compensation of $9.4 million, right-of-use asset impairment of $4.1 million, and depreciation and amortization of $1.6 million, which was offset by investment accretion and amortization of $4.5 million.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2023 was $62.8 million, primarily due to a net loss of $89.7 million, adjusted for $26.9 million of net non-cash charges consisting primarily of share-based compensation of $13.7 million, depreciation and amortization of $3.6 million, investment accretion and amortization of $6.9 million, non-cash lease expense of $1.7 million, impairment of right-of-use assets of $4.1 million, and a $10.8 million net change in operating assets and liabilities.

Previous wording

Net cash used by investing activities for the six months ended June 30, 2024 was $86.1 million, which consisted primarily of the purchase of marketable securities of $214.3 million and the purchase of property and equipment of $2.5 million, partially offset by proceeds from the maturities of marketable securities of $130.7 million.

Current wording

Net cash used by investing activities for the nine months ended September 30, 2024 was $125.0 million, which consisted primarily of the purchase of marketable securities of $320.7 million and the purchase of property and equipment of $3.3 million, partially offset by proceeds from the maturities of marketable securities of $198.9 million.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2023, was $33.8 million, which consisted primarily of proceeds from the maturities of marketable securities of $206.4 million, partially offset by the purchase of marketable securities of $157.5 million and the purchase of property and equipment of $15.2 million related to the construction of our manufacturing facility.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2023, was $63.2 million, which consisted primarily of proceeds from the sales and maturities of marketable securities of $281.4 million, partially offset by the purchase of marketable securities of $196.9 million and the purchase of property and equipment of $21.3 million related to the construction of our manufacturing facility.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024, was $225.9 million, which primarily consisted of net proceeds from our underwritten public offering of $225.1 million that closed in March 2024.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024, was $225.9 million, which primarily consisted of net proceeds from our underwritten public offering of $225.1 million that closed in March 2024.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2023, was $0.4 consisted of proceeds from stock options and the employee stock plan purchase.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2023, was $0.4 million, which consisted of proceeds from stock options and the employee stock plan purchase.

Previous wording

the type, number, scope, progress, expansions, results, costs and timing of our clinical trials and preclinical studies for our product candidates or other potential product candidates or indications which we are pursuing or may choose to pursue in the future;

Current wording

the type, number, scope, progress, enrollment rate, expansions, results, costs and timing of our clinical trials and preclinical studies for our product candidates or other potential product candidates or indications which we are pursuing or may choose to pursue in the future;

Previous wording

our ability to implement cost containment measures, including subleasing portions of our leased corporate office space in South San Francisco.

Current wording

our ability to closely monitor our expenditures, including subleasing portions of our leased corporate office space in South San Francisco.

Previous wording

Until such time as we can generate significant revenue from sales of our therapeutic product candidates, if ever, we expect to finance our cash needs through public or private equity, including pursuant to the ATM Offering Program, or debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. There may also be instances where our ability to access a portion of our existing cash, cash equivalents and investments may be threatened due to financial conditions affecting the banking system and financial markets. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us and may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to undertake additional cost-containment measures and/or delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Current wording

Until such time as we can generate significant revenue from sales of our therapeutic product candidates, if ever, we expect to finance our cash needs through public or private equity, including debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. There may also be instances where our ability to access a portion of our existing cash, cash equivalents and investments may be threatened due to financial conditions affecting the banking system and financial markets. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us and may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to undertake additional cost-containment measures and/or delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Previous wording

There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2024, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.

Current wording

There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2024, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K.