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Vera Therapeutics Inc

For the period ended Jun 30, 2024. Filed Aug 8, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 8, 2024

VERA$29.79-1.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-10.

0000950170-24-057292

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0000950170-24-094108

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 75 previous paragraphs and 78 current paragraphs.

50 unchanged; 24 reworded; 3 added; 0 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (3)

Current report

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 report

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 report

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.
Reworded paragraphs (24)

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 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. 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 HDA. 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 commitment of resources to the MAU868 program. We believe that our current pipeline programs leverage the deep expertise of our team and have strong potential commercial synergies. We hold global developmental and commercial rights to all of our pipeline molecule.

Current 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.

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 March 31, 2024, we had $403.7 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 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.

Previous wording

We have incurred significant operating losses since the commencement of our operations. Our net losses were $28.4 million and $30.1 million for the three months ended March 31, 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 March 31, 2024, we had an accumulated deficit of $337.5 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 $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.

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 months ended March 31, 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 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.

Previous wording

We believe that our existing cash, cash equivalents and marketable securities held as of March 31, 2024, will be sufficient to fund our operations 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 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.

Previous wording

Comparison of the Three Months Ended March 31, 2024 and 2023

Current wording

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

Previous wording

Research and development expenses decreased by $1.9 million, or 8%, to $23.2 million in the three months ended March 31, 2024, from $25.1 million in the three months ended March 31, 2023. Contract drug manufacturing expenses decreased by $7.7 million primarily due to the timing of the production of clinical drug supply in the first quarter of 2023 for our Phase 3 clinical trial of atacicept in IgAN, called ORIGIN 3, which initiated in the second quarter of 2023. Clinical trial expenses increased by $2.0 million due to increasing numbers of sites initiated and participants enrolled in ORIGIN 3 during the first quarter of 2024. Consulting and professional services increased by $1.6 million primarily due to increases in expenses for consultants, recruiting and placement fees for the hire of research and development personnel, and market research and other expenses incurred to prepare atacicept for approval application and commercial launch. Compensation and related benefits for research and development employees, including stock-based compensation, increased by $2.0 million due to growth in research and development headcount.

Current 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.

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 resume 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 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.

Previous wording

General and administrative expenses consist primarily of compensation and personnel-related expenses, including stock-based compensation, for our personnel in executive management, legal, finance, human resources, and other administrative functions. General and administrative expenses also include professional fees paid for accounting, auditing, legal, tax and consulting services, and other general overhead costs to support our operations. General and administrative expenses are recorded as expense in the period in which they are incurred, and payments we make prior to the receipt of goods or services to be used for general and administrative purposes efforts are deferred as prepaid expenses until the goods or services are received and used.

Current wording

General and administrative expenses consist primarily of compensation and personnel-related expenses, including stock-based compensation, for our personnel in executive management, legal, finance, human resources, and other administrative functions. General and administrative expenses also include professional fees paid for accounting, auditing, legal, tax and consulting services, and other general overhead costs to support our operations. General and administrative expenses are recorded as expense in the period in which they are incurred, and payments we make prior to the receipt of goods or services to be used for general and administrative purposes are deferred as prepaid expenses until the goods or services are received and used.

Previous wording

General and administrative expenses increased by $1.8 million, or 29%, to $7.9 million in the three months ended March 31, 2024, from $6.2 million in the three months ended March 31, 2023, due primarily to a $1.2 million increase in payroll and related expenses, including stock-based compensation, as a result of increased general and administrative employee headcount in the current period. Professional services, including legal expenses, recruiting and placement fees, audit and tax services, increased by $0.9 million, in aggregate. These increases were partially offset by a decrease of $0.3 million in insurance premium expenses.

Current 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.

Previous wording

Other income, net, increased by $1.5 million, to $2.7 million in the three months ended March 31, 2024, from $1.2 million in the three months ended March 31, 2023, due to an increase of $2.6 million in interest income from higher yields on marketable securities held in the current period, partially offset by an increase of $1.0 million in interest expense due to higher outstanding loan balances in the current period.

Current 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.

Previous wording

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of atacicept and MAU868, hire additional staff, including clinical, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials and clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Current wording

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of atacicept and MAU868, hire additional staff, including clinical, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $403.7 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 March 31, 2024 will be sufficient to fund our operations and capital expenditure requirements for at least 12 months subsequent to the issuance date of the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Current 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.

Previous wording

In the three months ended March 31, 2024, we used $33.8 million of cash in operating activities, attributable to a net loss of $28.4 million and a net change in our net operating assets and liabilities of $8.6 million, partially offset by non-cash charges of $3.2 million. Non-cash charges primarily consisted of $4.1 million of stock-based compensation, $1.5 million of depreciation, amortization and accretion and a $0.5 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to a decrease of $0.6 million in operating lease liabilities, a decrease of $1.7 million in accrued and other current liabilities, a decrease of $5.9 million in accounts payable and an increase of $0.4 million in prepaid expense and other current assets.

Current 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.

Previous wording

In the three months ended March 31, 2023, we used $26.3 million of cash in operating activities, attributable to a net loss of $30.1 million and a $6.7 million decrease in accounts payable, partially offset by a $4.6 million increase in accrued and other current liabilities, a $3.7 million decrease in prepaid expenses and other current assets and $2.7 million of non-cash stock-based compensation expense.

Current 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.

Previous wording

In the three months ended March 31, 2024, our investing activities used $219.3 million of cash, primarily resulting from $255.0 million for purchase of marketable securities, offset by $35.7 million provided by sales and maturities of marketable securities

Current 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.

Previous wording

In the three months ended March 31, 2023, our investing activities provided $12.2 million of cash, primarily resulting from $46.4 million of sales and maturities of marketable securities, partially offset by $34.2 million for purchases of marketable securities.

Current 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.

Previous wording

In the three months ended March 31, 2024, our financing activities provided $276.5 million of cash, resulting from $287.5 million gross proceeds from our February 2024 follow-on offering, $6.9 million proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan, partially offset by payment of $17.9 million in offering costs related to our February 2024 follow-on offering.

Current 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.

Previous wording

In the three months ended March 31, 2023, our financing activities provided $108.0 million of cash, resulting from $115.0 million gross proceeds from our February 2023 follow-on offering, partially offset by the payment of $7.3 million of related offering costs during the period.

Current 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.

Previous wording

During the three months ended March 31, 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 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.

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 $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 on December 22, 2023.

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

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 will 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 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.

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 current public float, we anticipate that when we reevaluate our filer status on December 31, 2024, we will determine that we qualify as a “large accelerated filer.”

Current 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.

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

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 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.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

$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 on December 22, 2023.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

10-Q. During the three months ended March 31, 2024, there were no material changes to our critical accounting policies and estimates from those discussed in our Annual Report.