Vera Therapeutics Inc

Previous wording

We are a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Immunoglobulin A nephropathy (IgAN) is a B cell disorder with a kidney pathology. Our lead product candidate, atacicept, is an at home, self-administered transmembrane activator and CAML interactor (TACI)-Fc fusion protein that blocks both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) with best-in-class potential for the treatment of IgAN. The Phase 2b ORIGIN clinical trial evaluating the safety and efficacy of atacicept in 116 participants with IgAN reported positive results at three timepoints: 24-week topline results in January 2023, 36-week results in June 2023, and 72-week results in January 2024. The trial remained blinded through 36 weeks, after which all participants were eligible for the open label extension portion of the study and received atacicept 150 mg through 96 weeks. At 24 and 36 weeks, respectively, atacicept met its primary endpoint with statistically significant reductions in urine protein creatinine ratio (UPCR) on atacicept 150 mg, and stable estimated glomerular filtration rate (eGFR) was observed for participants on atacicept, with clinically meaningful and statistically significant difference versus placebo. Participants treated with atacicept demonstrated reductions in galactose-deficient IgA1 (Gd-IgA1), the autoantigen produced by B cells in patients with IgAN, and a reduction in hematuria. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 72-week open label extension results showed consistent and sustained reductions in Gd-IgA1, hematuria, UPCR and continued eGFR stabilization. Additionally, atacicept’s safety profile was comparable to placebo. We advanced atacicept 150 mg in a pivotal Phase 3 clinical trial in IgAN in the second quarter of 2023, and we expect to report top line results in the second quarter of 2025. The Phase 2 portion of the ORIGIN clinical trial has been completed, and we expect to report final results from the 96-week trial in the fourth quarter of 2024. We believe that atacicept has pipeline in a molecule potential, with potential application in additional indications including systemic lupus erythematosus (SLE) and lupus nephritis (LN), a severe renal manifestation of SLE. We have designed and are poised to conduct a Phase 3 clinical trial of atacicept in LN, based on feedback from the FDA’s review of clinical results in a Phase 2 clinical trial of atacicept in SLE patients with high disease activity. We also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections, for which we completed a Phase 2 clinical trial in 2022. In January 2023, we delayed enrollment in the pivotal Phase 3 trial for LN and commitmen…

Excerpt shortened here; the source contains the full paragraph.

Current wording

We are a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases. Our lead product candidate, atacicept, a self-administered fusion protein that blocks both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), is currently being evaluated for the treatment of immunoglogulin A nephropath (IgAN). We are enrolling the pivotal Phase 3 ORIGIN 3 trial of atacicept 150 mg in IgAN, and in September 2024 completed enrollment of the initial cohort of 200 participants that will provide data for the 36-week urine protein creatinine ratio (UPCR) primary efficacy endpoint. We expect to announce topline results for this primary endpoint in the second quarter of 2025, supporting the planned submission for regulatory approval later in 2025. The Phase 2b ORIGIN clinical trial evaluated the safety and efficacy of atacicept in 116 participants with IgAN and reported positive results at four timepoints: 24-week topline results in January 2023, 36-week results in June 2023, 72-week results in January 2024 and 96-week results in October 2024. The trial remained blinded through 36 weeks, after which all participants were eligible for the open label extension portion of the study and received atacicept 150 mg through 96 weeks. At 24 and 36 weeks, respectively, atacicept met its primary endpoint with statistically significant reductions in UPCR on atacicept 150 mg, and stable estimated glomerular filtration rate (eGFR) was observed for participants on atacicept, with clinically meaningful and statistically significant difference versus placebo. Participants treated with atacicept demonstrated reductions in galactose-deficient IgA1 (Gd-IgA1), the autoantigen produced by B cells in patients with IgAN, and a reduction in hematuria. The improvements in Gd-IgA1, hematuria, UPCR and eGFR represent the quartet of findings consistent with IgAN disease modification. The 72-week and 96-week open label extension results showed consistent and sustained reductions in Gd-IgA1, hematuria, UPCR and continued eGFR stabilization. Additionally, atacicept’s safety profile was comparable to placebo. We believe that atacicept has pipeline in a molecule potential, with potential application in multiple diseases. We will be testing atacicept in non-IgAN autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD), in the Phase 2 PIONEER clinical trial that will initiate in 2025. It is estimated that there are approximately 35,000 patients with pMN and an additional 35,000 patients with either FSGS or MCD in the United States. Potential future indications include several rheumatologic diseases such as systemic lupus erythematosus and Sjogren’s disease, and hematologic diseases, including idiopathic thrombocytopenic purpura and autoimmune hemolytic anemia. We also hold worldwide, excl…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of June 30, 2024, we had $384.4 million in cash, cash equivalents and marketable securities, compared to $160.7 million as of December 31, 2023.

Current wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of September 30, 2024, we had $353.3 million in cash, cash equivalents and marketable securities, compared to $160.7 million as of December 31, 2023.

Previous wording

We have incurred significant operating losses since the commencement of our operations. Our net losses were $33.7 million and $20.2 million for the three months ended June 30, 2024 and 2023, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates, atacicept and MAU868, to commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of June 30, 2024, we had an accumulated deficit of $371.2 million, compared to $309.1 million as of December 31, 2023. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

Current wording

We have incurred significant operating losses since the commencement of our operations. Our net losses were $46.6 million and $20.1 million for the three months ended September 30, 2024 and 2023, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates, atacicept and MAU868, to commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of September 30, 2024, we had an accumulated deficit of $417.8 million, compared to $309.1 million as of December 31, 2023. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

Previous wording

continue our ongoing and planned development of our product candidates, atacicept for the treatment of IgAN and LN, and MAU868 for the treatment of BK viremia;

Current wording

continue our ongoing and planned development of our product candidates, atacicept and MAU868;

Previous wording

Due to geopolitical and macroeconomic events, bank failures, supply chain challenges, ongoing military conflicts, related sanctions, changes in U.S.-China relations, increasing inflation rates and the responses by central banking authorities to control such inflation, the U.S. and global financial markets experienced volatility, which has led to disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally. As a result of these factors and other geopolitical and macroeconomic developments described in this Quarterly Report, our business and results of operations may be adversely affected.

Current wording

Due to geopolitical and macroeconomic events, bank failures, supply chain challenges, ongoing military conflicts, related sanctions, changes in U.S.-China relations, elevated inflation rates and the responses by central banking authorities to control such inflation, the U.S. and global financial markets experienced volatility, which has led to disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally. As a result of these factors and other geopolitical and macroeconomic developments described in this Quarterly Report, our business and results of operations may be adversely affected.

Previous wording

Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments during the three and six months ended June 30, 2024, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict such as disruptions or restrictions in our supply chain, disruption or restrictions on our employees’ ability to travel, disruptions to or delays in ongoing non-clinical trials, clinical trials, third-party manufacturing supply and other operations, adverse geopolitical and macroeconomic concerns, interruptions or delays in the operations of the FDA or other regulatory authorities, continued increases in inflation and interest rates, or changes in availability and cost of credit and our ability to raise capital and conduct business development activities. The ultimate impact of these geopolitical and macroeconomic developments, as well as any lasting effects on our business, is highly uncertain and subject to continued change, and we recognize that macroeconomic and geopolitical factors may continue to present unique challenges for us.

Current wording

Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments during the three and nine months ended September 30, 2024, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict such as disruptions or restrictions in our supply chain, disruption or restrictions on our employees’ ability to travel, disruptions to or delays in ongoing non-clinical trials, clinical trials, third-party manufacturing supply and other operations, adverse geopolitical and macroeconomic concerns, interruptions or delays in the operations of the FDA or other regulatory authorities, continued increases in inflation and interest rates, or changes in availability and cost of credit and our ability to raise capital and conduct business development activities. The ultimate impact of these geopolitical and macroeconomic developments, as well as any lasting effects on our business, is highly uncertain and subject to continued change, and we recognize that macroeconomic and geopolitical factors may continue to present unique challenges for us.

Previous wording

We believe that our existing cash, cash equivalents and marketable securities held as of June 30, 2024, will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. However, should adverse geopolitical and macroeconomic events, bank failures, supply chain challenges, ongoing military conflicts, related sanctions, changes in U.S.-China relations, increasing inflation rates and the responses by central banking authorities to control such inflation, any recession or depression associated with those events or other events described herein, continue for a prolonged period, our results of operations, financial condition, liquidity and cash flows could be materially impacted as a result of a lower likelihood of effectively and efficiently developing and successfully commercializing our product candidates.

Current wording

We believe that our existing cash, cash equivalents and marketable securities held as of September 30, 2024, will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. However, should adverse geopolitical and macroeconomic events, bank failures, supply chain challenges, ongoing military conflicts, related sanctions, changes in U.S.-China relations, elevated inflation rates and the responses by central banking authorities to control such inflation, any recession or depression associated with those events or other events described herein, continue for a prolonged period, our results of operations, financial condition, liquidity and cash flows could be materially impacted as a result of a lower likelihood of effectively and efficiently developing and successfully commercializing our product candidates.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

Research and development expenses increased by $13.1 million, or 81%, to $29.3 million in the three months ended June 30, 2024, from $16.2 million in the three months ended June 30, 2023, due primarily to an increase of $8.3 million in contract drug manufacturing and related activities for atacicept resulting from the commencement of atacicept drug substance manufacturing to be used for process performance qualification, an increase of $1.0 million in clinical trial expenses due to a greater number of sites initiated and participants enrolled in our Phase 3 clinical trial of atacicept in IgAN, called ORIGIN 3, an increase of $1.9 million in consulting and professional services, including a $1.3 million increase in commercial planning and medical affairs expenses, and an increase of $1.7 million for compensation and related benefit expenses, including stock-based compensation expense due to growth in research and development headcount.

Current wording

Research and development expenses increased by $24.2 million, or 150%, to $40.3 million in the three months ended September 30, 2024, from $16.1 million in the three months ended September 30, 2023, due primarily to an increase of $15.6 million in contract drug manufacturing and related activities for atacicept resulting from manufacturing of drug substance process performance qualification batches for both commercial and clinical use, an increase of $3.8 million in clinical trial expenses due to greater numbers of active sites and participants enrolling in ORIGIN 3, an increase of $1.3 million in consulting and professional services, including a $1.0 million increase in commercial planning and medical affairs expenses, and an increase of $3.2 million for compensation and related benefit expenses, including a $1.1 million increase in stock-based compensation expense, due to growth in research and development headcount.

Previous wording

Research and development expenses increased by $11.2 million, or 27%, to $52.5 million in the six months ended June 30, 2024, from $41.3 million in the six months ended June 30, 2023, due primarily to an increase of $4.0 million in clinical trial expenses due to a greater number of sites initiated and participants enrolled in ORIGIN 3, an increase of $3.4 million in consulting and professional services, including a $2.0 million increase in commercial planning and medical affairs expenses and a $0.6 million increase in recruiting and placement fees, and an increase of $3.7 million for compensation and related benefit expenses, including stock-based compensation due to growth in research and development headcount.

Current wording

Research and development expenses increased by $35.4 million, or 62%, to $92.8 million in the nine months ended September 30, 2024, from $57.4 million in the nine months ended September 30, 2023, due primarily to an increase of $16.1 million in contract drug manufacturing and related activities for atacicept resulting from manufacturing of drug substance process performance qualification batches for both commercial and clinical use, $6.8 million in clinical trial expenses due to greater numbers of active sites and participants enrolling in ORIGIN 3, an increase of $4.7 million in consulting and professional services, including a $3.0 million increase in commercial planning and medical affairs expenses, and an increase of $6.9 million for compensation and related benefit expenses, including a $2.4 million increase stock-based compensation, due to growth in research and development headcount.

Previous wording

We expect our research and development expenses to increase in future periods as we continue to initiate additional sites and enroll participants in ORIGIN 3 and prepare for applications for regulatory approval of atacicept in IgAN, and if we expand development of other indications or product candidates.

Current wording

We expect our research and development expenses to increase in future periods as we continue to initiate sites and enroll participants in ORIGIN 3, prepare for applications for regulatory approval of atacicept in IgAN, initiate and conduct additional clinical trials of atacicept, including the PIONEER trial, and if we expand development of atacicept in other indications or product configurations, or other product candidates.

Previous wording

General and administrative expenses increased by $2.3 million, or 40%, to $8.0 million in the three months ended June 30, 2024, from $5.7 million in the three months ended June 30, 2023, due primarily to an increase of $1.5 million in payroll and related expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $0.2 million in audit and tax-related fees, and an increase of $0.5 million in expenses for consultants and compensation to non-employee directors.

Current wording

General and administrative expenses increased by $3.8 million, or 68%, to $9.5 million in the three months ended September 30, 2024, from $5.7 million in the three months ended September 30, 2023, due primarily to an increase of $1.9 million in payroll and related expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $0.5 million in stock-based compensation expense for consultants and non-employee directors, an increase of $0.4 million in outside legal expenses and an increase of $0.2 million in recruiting and placement fees for general and administrative hires.

Previous wording

General and administrative expenses increased by $4.1 million, or 34%, to $15.9 million in the six months ended June 30, 2024, from $11.9 million in the six months ended June 30, 2023, due primarily to an increase of $2.7 million in payroll and related expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $0.5 million in outside legal expenses, an increase of $0.4 million in audit and tax-related fees and an increase of $0.4 million in expenses for consultants and compensation to non-employee directors, partially offset by a $0.4 million decrease in insurance premium expenses.

Current wording

General and administrative expenses increased by $7.9 million, or 45%, to $25.4 million in the nine months ended September 30, 2024, from $17.5 million in the nine months ended September 30, 2023, due primarily to an increase of $4.6 million in payroll and related expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $1.0 million in stock-based compensation expense for consultants and non-employee directors, an increase of $0.9 million in outside legal expenses, and an increase of $0.4 million in recruiting and placement fees for general and administrative hires.

Previous wording

Other income, net, increased by $1.8 million, to $3.6 million in the three months ended June 30, 2024, from $1.8 million in the three months ended June 30, 2023, due to an increase of $2.9 million in interest income from greater balances of marketable securities held, partially offset by an increase of $1.0 million in interest expense due to higher outstanding loan principal balances in the current period.

Current wording

Other income and expenses, net, increased by $1.5 million, to $3.2 million in the three months ended September 30, 2024, from $1.7 million in the three months ended September 30, 2023, due to an increase of $2.6 million in interest income from greater balances of marketable securities held, partially offset by an increase of $1.0 million in interest expense due to higher outstanding loan principal balances in the current period.

Previous wording

Other income, net, increased by $3.4 million, to $6.4 million in the six months ended June 30, 2024, from $3.0 million in the six months ended June 30, 2023, due to an increase of $5.4 million in interest income from greater balances of marketable securities held, partially offset by an increase of $2.0 million in interest expense due to higher outstanding loan principal balances in the current period.

Current wording

Other income and expenses, net, increased by $4.9 million, to $9.5 million in the nine months ended September 30, 2024, from $4.6 million in the nine months ended September 30, 2023, due to an increase of $8.0 million in interest income from greater balances of marketable securities held, partially offset by an increase of $3.0 million in interest expense due to higher outstanding loan principal balances in the current period.

Previous wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible notes. From our inception through June 30, 2024, we have raised aggregate net cash proceeds of approximately $697.0 million from the issuance and sale of redeemable convertible preferred stock, convertible notes and common stock, and proceeds from our Loan Agreement with Oxford Finance LLC (Oxford). Since the date of our incorporation, we have not generated any revenue from product sales and have incurred substantial operating losses and negative cash flows from operations.

Current wording

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible notes. From our inception through November 5, 2024, we have raised aggregate net cash proceeds of approximately $1.0 billion from the issuance and sale of redeemable convertible preferred stock, convertible notes and common stock, and proceeds from our Loan Agreement with Oxford Finance LLC (Oxford). Since the date of our incorporation, we have not generated any revenue from product sales and have incurred substantial operating losses and negative cash flows from operations.

Previous wording

In February 2024, we completed a follow-on public offering and issued 9,274,194 shares of common stock for net proceeds of approximately $269.6 million, after deducting underwriting discounts and commissions and offering related expenses.

Current wording

In February 2024, we completed a follow-on public offering and issued 9,274,194 shares of common stock for net proceeds of approximately $269.6 million, after deducting underwriting discounts and commissions and offering-related expenses. In October 2024, we completed a follow-on public offering and issued 7,142,858 shares of common stock, and in November 2024 we issued an additional 1,071,428 shares of common stock pursuant to the underwriters’ full exercise of the 30-day option to purchase additional shares. We received aggregate net proceeds of approximately $323.6 million, after deducting underwriting discounts and commissions and offering-related expenses.

Previous wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $384.4 million, as compared to $160.7 million as of December 31, 2023. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of June 30, 2024 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

Current wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $353.3 million, as compared to $160.7 million as of December 31, 2023. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

Previous wording

In the six months ended June 30, 2024, we used $58.6 million of cash in operating activities, attributable to a net loss of $62.1 million, $4.5 million of non-cash interest income and a net change in operating assets and liabilities of $2.5 million, partially offset by non-cash operating expenses of $9.9 million. Non-cash operating expenses primarily consisted of $9.0 million of stock-based compensation and a $1.0 million reduction in the carrying amount of operating lease right-of-use assets. The net change in operating assets and liabilities was primarily due to a decrease of $6.5 million in accounts payable and a decrease of $1.3 million in operating lease liabilities, partially offset by an increase of $2.9 million in accrued and other current liabilities and an increase of $2.3 million in prepaid expense and other current assets.

Current wording

In the nine months ended September 30, 2024, we used $95.5 million of cash in operating activities, attributable to a net loss of $108.7 million and $6.9 million of non-cash interest income, partially offset by non-cash operating expenses of $16.1 million and a net change in operating assets and liabilities of $3.4 million. Non-cash operating expenses primarily consisted of $14.6 million of stock-based compensation and a $1.5 million reduction in the carrying amount of operating lease right-of-use assets. The net change in operating assets and liabilities was primarily due to an increase of $11.0 million in accrued and other current liabilities, partially offset by a decrease of $6.5 million in accounts payable and a decrease of $1.9 million in operating lease liabilities.

Previous wording

In the six months ended June 30, 2023, we used $44.1 million of cash in operating activities, primarily attributable to a net loss of $50.2 million, partially offset by $5.3 million of non-cash stock-based compensation expense.

Current wording

In the nine months ended September 30, 2023, we used $67.0 million of cash in operating activities, primarily attributable to a net loss of $70.3 million, non-cash interest income of $3.2 million related to amortization of discount on purchases of marketable securities and $3.7 million of changes in working capital, partially offset by $8.3 million of non-cash stock-based compensation expense.

Previous wording

In the six months ended June 30, 2024, our investing activities used $242.0 million of cash, primarily resulting from $336.1 million for purchase of marketable securities, offset by $94.2 million provided by sales and maturities of marketable securities.

Current wording

In the nine months ended September 30, 2024, our investing activities used $203.6 million of cash, primarily resulting from $409.0 million for purchases of marketable securities, offset by $205.7 million provided by sales and maturities of marketable securities.

Previous wording

In the six months ended June 30, 2023, our investing activities used $74.2 million of cash, primarily resulting from $143.1 million for purchase of marketable securities, partially offset by $68.8 million provided by sales and maturities of marketable securities.

Current wording

In the nine months ended September 30, 2023, our investing activities used $58.0 million of cash, primarily resulting from $171.7 million for purchases of marketable securities, partially offset by $113.7 million provided by sales and maturities of marketable securities.

Previous wording

In the six months ended June 30, 2024, our financing activities provided $280.0 million of cash, resulting from $287.5 million gross proceeds from our February 2024 follow-on offering, $10.4 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by $17.9 million of costs and underwriting discounts and commissions related to our February 2024 follow-on offering.

Current wording

In the nine months ended September 30, 2024, our financing activities provided $280.7 million of cash, resulting from $287.5 million gross proceeds from our February 2024 follow-on offering, $11.1 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by $17.9 million of costs and underwriting discounts and commissions related to our February 2024 follow-on offering.

Previous wording

In the six months ended June 30, 2023, our financing activities provided $108.4 million of cash, resulting from $115.0 million gross proceeds from our February 2023 follow-on offering, $0.7 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by $7.3 million of costs and underwriting discounts and commissions related to our February 2023 follow-on offering.

Current wording

In the nine months ended September 30, 2023, our financing activities provided $108.7 million of cash, resulting from $115.0 million gross proceeds from our February 2023 follow-on offering, $1.0 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by $7.3 million of costs and underwriting discounts and commissions related to our February 2023 follow-on offering.

Previous wording

During the six months ended June 30, 2024, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K.

Current wording

During the nine months ended September 30, 2024, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K.

Previous wording

On December 17, 2021, we entered into the Loan Agreement with Oxford, a Delaware limited liability company, as lender (Lender) and collateral agent. The Loan Agreement provides for a term loan (the Loan) in an aggregate maximum principal amount of

Current wording

On December 17, 2021, we entered into the Loan Agreement with Oxford, a Delaware limited liability company, as lender (Lender) and collateral agent. The Loan Agreement provides for a term loan (the Loan) in an aggregate maximum principal amount of $50.0 million, of which $5.0 million was funded on December 17, 2021, $20.0 million was funded on November 4, 2022, and the remaining $25.0 million was funded in December 2023.

Previous wording

In June 2022, we entered into a sales agreement with Cowen and Company LLC (Cowen) as sales agent, pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering price of $150.0 million under an at-the-market offering program (ATM). We would pay Cowen up to 3.0% of gross proceeds of the common stock sold through the ATM. Effective January 29, 2024, we suspended and terminated the prospectus related to the sale of common stock under the ATM. As a result, we will not make any sales of common stock pursuant to the ATM unless and until a new prospectus, prospectus supplement or registration statement is filed.

Current wording

In June 2022, we entered into a sales agreement with Cowen and Company LLC (Cowen) as sales agent, pursuant to which we had the option to issue and sell shares of our common stock for an aggregate maximum offering price of $150.0 million under an at-the-market offering program (ATM). We would pay Cowen up to 3.0% of gross proceeds of the common stock sold through the ATM. Effective January 29, 2024, we suspended and terminated the prospectus related to the sale of common stock under the ATM. As a result, we will not make any sales of common stock pursuant to the ATM unless and until a new prospectus, prospectus supplement or registration statement is filed.

Previous wording

We will remain an emerging growth company under the JOBS Act until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenue of $1.235 billion or more, (ii) the date on which we have issued more than $1.0 billion of non-convertible debt instruments during the previous three fiscal years, (iii) the date on which we are deemed a “large accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates, or (iv) December 31, 2026. Based on our public float as of June 28, 2024, the last business day of our second quarter, when we reevaluate our filer status on December 31, 2024, we will qualify as a “large accelerated filer” and will no longer be an emerging growth company.

Current wording

We are an emerging growth company, as defined in the JOBS Act. We will remain an emerging growth company under the JOBS Act until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenue of $1.235 billion or more, (ii) the date on which we have issued more than $1.0 billion of non-convertible debt instruments during the previous three fiscal years, (iii) the date on which we are deemed a “large accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates, or (iv) December 31, 2026. Based on our public float as of June 28, 2024, the last business day of our second quarter, when we reevaluate our filer status on December 31, 2024, we will qualify as a “large accelerated filer” and will no longer be an emerging growth company.

Previous wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in our Annual Report.

Current wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in our Annual Report.