Cabaletta Bio Inc

Previous wording

We are a clinical-stage biotechnology company focused on the discovery and development of innovative engineered T cell therapies that have the potential to provide deep and durable, perhaps curative, responses with one-time administration for patients with autoimmune diseases. Our proprietary CABA®, or Cabaletta Approach to B cell Ablation, platform encompasses two strategies. Our CARTA, or Chimeric Antigen Receptor T cells for Autoimmunity, approach is designed to potentially reset the immune system. Our legacy CAART, or Chimeric AutoAntibody Receptor T cells, approach is designed to engineer T cells to selectively engage and eliminate only disease-causing B cells. We believe our CABA® platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases.

Current wording

We are a clinical-stage biotechnology company focused on the discovery and development of innovative engineered T cell therapies that have the potential to provide deep and durable, perhaps curative, responses with one-time administration for patients with autoimmune diseases. Our proprietary CABA®, or Cabaletta Approach to B cell Ablation, platform encompasses two strategies. Our CARTA, or Chimeric Antigen Receptor T cells for Autoimmunity, approach is designed to potentially reset the immune system. Our legacy CAART, or Chimeric AutoAntibody Receptor T cells, approach is designed to engineer T cells to selectively engage and eliminate only disease-causing B cells. We believe our CABA® platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases and that it has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.

Previous wording

The CARTA strategy is designed to achieve transient and complete depletion of all B cells following a single treatment by using T cells engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells. The construct is designed to allow for the complete elimination of all B cells, including all B cells that contribute to disease, with subsequent repopulation by healthy naïve B cells. This approach has the potential to reset the immune system, providing meaningful durable and complete clinical responses to patients off immunosuppressive therapies. The legacy CAART strategy is designed to selectively engage and eliminate only the pathogenic B cells responsible for driving disease by using T cells engineered to express disease specific targeting domains which are designed to mimic the antigen that is the subject of attack in an autoimmune disease. Our CAARs differ from chimeric antigen receptors, or CARs, in the use of the autoantigen rather than an antibody fragment, which may enable the CAAR T cells to serve as a “decoy” for specific autoreactive B cell receptors expressed on the surface of B cells, engaging them and resulting in their elimination. We believe our CABA® platform has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.

Current wording

The CARTA strategy is designed to achieve transient and complete depletion of all B cells following a single treatment by using T cells engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells. The construct is designed to allow for the complete elimination of all B cells, including all B cells that contribute to disease, with subsequent repopulation by healthy naïve B cells. This approach has the potential to reset the immune system, providing meaningful durable and complete clinical responses to patients off immunosuppressive therapies.

Previous wording

15 and 40 with higher frequency and more severity in people of color, where the immune system attacks healthy tissue throughout the body. SLE affects an estimated 160,000-320,000 patients in the U.S, with LN as the most common end-organ manifestation, affecting approximately 40% of SLE patients. In May 2023, we announced the FDA granted Fast Track Designation for CABA-201, designed to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN. The RESET-SLETM Phase 1/2 clinical trial of CABA-201 is designed to treat six SLE patients with active LN, and in a separate parallel cohort, six patients with active SLE without renal involvement, with an initial dose, 1.0 x 106 cells/kg, that is equivalent to the dose used in the academic reports of a 4-1BB containing CD19-CAR T construct evaluated in patients with SLE. The trial is open for enrollment across multiple sites in the United States. In March 2024, Health Canada issued a No Objection Letter in response to a Clinical Trial Application for the RESET-SLETM trial submitted by Cabaletta, enabling the Company to begin the process to activate clinical trial sites and pursue patient enrollment for the RESET-SLETM trial in Canada.

Current wording

In March 2023, the United States Food and Drug Administration, or the FDA, granted clearance of our CABA-201 Investigational New Drug, or IND, application for treatment of SLE in patients with active lupus nephritis, or LN, or active SLE without renal involvement. SLE is a chronic, potentially severe, autoimmune disease, most commonly impacting young women between the ages of 15 and 40 with higher frequency and more severity in people of color, where the immune system attacks healthy tissue throughout the body. SLE affects an estimated 160,000-320,000 patients in the U.S, with LN as the most common end-organ manifestation, affecting approximately 40% of SLE patients. In May 2023, we announced the FDA granted Fast Track Designation for CABA-201, designed to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN. The RESET-SLETM Phase 1/2 clinical trial of CABA-201 is designed to treat six SLE patients with active LN, and in a separate parallel cohort, six patients with active SLE without renal involvement, with an initial dose, 1.0 x 106 cells/kg, that is equivalent to the dose used in the academic reports of a 4-1BB containing CD19-CAR T construct evaluated in patients with SLE. The trial is open for enrollment across multiple sites in the United States. In March 2024, Health Canada issued a No Objection Letter in response to a Clinical Trial Application, or CTA, for the RESET-SLETM trial submitted by Cabaletta, enabling us to begin the process to activate clinical trial sites and pursue patient enrollment for the RESET-SLETM trial in Canada. In October 2024, the European Medicines Agency allowed a CTA submitted by Cabaletta for the RESET-SLE trial to proceed, enabling us to begin the process of activating clinical trial sites and pursuing patient enrollment for the RESET-SLE trial.

Previous wording

In May 2024, we announced that we are working with active clinical sites to incorporate the RESET-PVTMsub-study within the Phase 1 DesCAARTes TM trial following the submission of a protocol amendment. The RESET-PVTM sub-study will evaluate CABA-201 as a monotherapy without preconditioning in patients with mucosal pemphigus vulgaris, or mPV, and mucocutaneous pemphigus vulgaris, or mcPV.

Current wording

In May 2024, we announced that we are working with active clinical sites to incorporate the RESET-PVTM trial as a sub-study within the Phase 1 DesCAARTes TM trial following the submission of a protocol amendment. The RESET-PVTM trial will evaluate CABA-201 as a monotherapy without preconditioning in patients with mucosal pemphigus vulgaris, or mPV, and mucocutaneous pemphigus vulgaris, or mcPV. The trial is open for enrollment across multiple sites in the United States.

Previous wording

Independent Data Monitoring Committee reviewed data from the patient, and recommended that the study proceed as designed, without delay, at the current dose. We have proposed and are implementing protocol modifications designed to improve patient safety, including enhanced monitoring for fever and neurologic symptoms along with seizure prophylaxis for all patients, in line with the practice at many academic sites including at Erlangen University, the site of the CD19-CAR T studies led by Dr. Georg Schett. Last month, we provided standard notice to the FDA and communicated details of the event and proposed protocol changes to all active clinical sites within the RESETTM clinical trial program.

Current wording

In late June 2024, a lupus nephritis patient with very active, refractory disease was dosed and experienced Grade 1 CRS and a protocol-defined dose-limiting toxicity of Grade 4 ICANS. The ICANS resolved rapidly following standard management. The study’s Independent Data Monitoring Committee reviewed data from the patient, and recommended that the study proceed as designed, without delay, at the current dose. We recommended protocol modifications designed to improve patient safety, including enhanced monitoring for fever and neurologic symptoms along with seizure prophylaxis for all patients, in line with the practice at many academic sites including at Erlangen University, the site of the CD19-CAR T studies led by Dr. Georg Schett. In July 2024, we provided standard notice to the FDA and communicated details of the event and proposed protocol changes to all active clinical sites within the RESETTM clinical trial program.

Previous wording

Our MuSK-CAART product candidate is designed to treat a subset of patients with MG, targeting autoreactive B cells that differentiate into antibody secreting cells that produce autoantibodies against a transmembrane protein, muscle-specific kinase, or MuSK, or MuSK-associated myasthenia gravis, or MuSK MG. Based on review of the initial clinical data and the data from the DSG3-CAART trial, the MusCAARTes TM trial is currently dosing patients in the A2 cohort, where patients are treated with MuSK-CAART without preconditioning.

Current wording

Our MuSK-CAART product candidate is designed to treat a subset of patients with MG, targeting autoreactive B cells that differentiate into antibody secreting cells that produce autoantibodies against a transmembrane protein, muscle-specific kinase, or MuSK, or MuSK-associated myasthenia gravis, or MuSK MG. The MusCAARTes TM trial is not currently dosing patients as we evaluate clinical and translational data from the A1 and A2 cohorts, where patients were treated with MuSK-CAART without preconditioning. In October 2024, we presented data in a poster presentation at ESGCT that indicated MuSK-CAART cells demonstrated evidence of biologic and clinical activity in treated patients, suggesting it may be possible to achieve clinical activity with CAR T cells in patients with autoimmune disease without preconditioning. The MusCAARTes™ trial is not currently dosing patients as we evaluate clinical and translational data from the first two cohorts.

Previous wording

We plan to secure commercial, scalable manufacturing capabilities through multiple potential strategies, including expanding existing or establishing new CDMO relationships, leasing, building, qualifying and operating our own manufacturing facility, and/or establishing a strategic partnership to rapidly and reliably scale manufacturing by leveraging the partner’s manufacturing expertise. We believe this later stage will enable control of product development and commercial supply for products arising from our CABA™ platform, enabling us to achieve continuous improvement of our product candidates. Multiple members of our team have previously built and led organizations that have constructed and commissioned cell therapy facilities, which we believe will enable us to build our own manufacturing organizations and facilities, if desirable. In June 2024, we hired Sarah Yuan, PhD, as Chief Technology Officer, fully dedicated to manufacturing technology and supply strategy at the Company.

Current wording

We plan to secure commercial, scalable manufacturing capabilities through multiple potential strategies, including expanding existing or establishing new CDMO relationships, leasing, building, qualifying and operating our own manufacturing facility, and/or establishing a strategic partnership to rapidly and reliably scale manufacturing by leveraging the partner’s manufacturing expertise. We believe this later stage will enable control of product development and commercial supply for products arising from our CABA™ platform, enabling us to achieve continuous improvement of our product candidates. Multiple members of our team have previously built and led organizations that have constructed and commissioned cell therapy facilities, which we believe will enable us to build our own manufacturing organizations and facilities, if desirable.

Previous wording

We were incorporated in April 2017 and started principal operations in August 2018. Our operations to date have been financed primarily by proceeds from the sale of convertible notes and convertible preferred stock prior to our initial public offering, or IPO, and proceeds from the sale of our common stock in public equity offerings, including our IPO, “at-the-market” offerings and follow-on offerings of shares of our common stock and pre-funded warrants As of June 30, 2024, we had $203.2 million in cash, cash equivalents and investments.

Current wording

We were incorporated in April 2017 and started principal operations in August 2018. Our operations to date have been financed primarily by proceeds from the sale of convertible notes and convertible preferred stock prior to our initial public offering, or IPO, and proceeds from the sale of our common stock in public equity offerings, including our IPO, “at-the-market” offerings and follow-on offerings of shares of our common stock and pre-funded warrants As of September 30, 2024, we had $183.0 million in cash, cash equivalents and investments.

Previous wording

In January 2021, we entered into a Development and Manufacturing Services Agreement, or the WuXi Agreement, with WuXi to serve as an additional cell processing manufacturing partner for the MuSK-CAART Phase 1 clinical trial, or MusCAARTes TM trial. The WuXi Agreement is scheduled to expire upon completion of WuXi’s services related to MuSK-CAART and CABA-201. In August 2023, we entered into new work orders under the WuXi Agreement for WuXi to serve as one of our cell processing manufacturing partners for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201. Under the August 2023 work orders, WuXi converted our non-dedicated suite to a dedicated suite for GMP manufacturing for our CABA-201 and MuSK-CAART programs, or the Dedicated Suite, for an initial term of 18 months with two 18 month extensions at our sole option on six months' notice prior to the end of the term. In addition, we agreed to certain monthly minimum runs. In lieu of the original $1.5 million termination fee under the terms of the WuXi Agreement, we would incur a $1.08 million termination fee if we terminate both the CABA-201 and MuSK-CAART work orders for any reason. We may terminate for convenience the WuXi Agreement or any work order with six months' prior written notice, however, we may not terminate the Dedicated Suite without terminating both the MuSK-CAART and CABA-201 GMP run work orders. WuXi may terminate the WuXi Agreement or any work order for convenience on 18 months' prior written notice, but such notice may not be effective prior to February

Current wording

In January 2021, we entered into a Development and Manufacturing Services Agreement, or the WuXi Agreement, with WuXi to serve as an additional cell processing manufacturing partner for the MuSK-CAART Phase 1 clinical trial, or MusCAARTes TM trial. The WuXi Agreement is scheduled to expire upon completion of WuXi’s services related to MuSK-CAART and CABA-201. In August 2023, as amended in August 2024, we entered into an agreement with WuXi to serve as one of our manufacturing partners for the global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201. Under the August 2023 work orders, WuXi converted our non-dedicated suite to a dedicated suite for GMP manufacturing for our CABA-201 and MuSK-CAART programs, or the Dedicated Suite, for an initial term of 18 months with two 18 month extensions at our sole option on six months' notice prior to the end of the term. In August 2024, we notified WuXi that we would extend the initial term by 18 months through August 2026. In addition, we agreed to certain monthly minimum runs. In August 2024, the 2023 work order related to GMP manufacturing was amended to reduce the minimum monthly runs through the end of 2024. In lieu of the original $1.5 million termination fee under the terms of the WuXi Agreement, we would incur a $1.08 million termination fee if we terminate both the CABA-201 and MuSK-CAART work orders for any reason. We may terminate for convenience the WuXi Agreement or any work order with six months' prior written notice, however, we may not terminate the Dedicated Suite without terminating both the MuSK-CAART and CABA-201 GMP run work orders. WuXi may terminate the WuXi Agreement or any work order for convenience on 18 months' prior written notice, but such notice may not be effective prior to February 2028.

Previous wording

successful completion of preclinical studies and IND-enabling studies;

Current wording

successful completion of preclinical studies and IND and/or CTA-enabling studies;

Previous wording

development of chemistry, manufacturing and controls, or CMC, processes and procedures for purposes of IND applications;

Current wording

development of chemistry, manufacturing and controls, or CMC, processes and procedures for purposes of IND and/or CTA applications;

Previous wording

Research and development expenses were $23.4 million for the three months ended June 30, 2024 compared to $11.8 million for the three months ended June 30, 2023. The table below summarizes our research and development expenses:

Current wording

Research and development expenses were $26.3 million for the three months ended September 30, 2024 compared to $13.8 million for the three months ended September 30, 2023. The table below summarizes our research and development expenses:

Previous wording

$4.2 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our CARTA strategy, including an increase of $1.2 million in stock-based compensation expense;

Current wording

$4.6 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our CARTA strategy, including an increase of $1.4 million in stock-based compensation expense;

Previous wording

$3.6 million increase in clinical trial costs primarily due to CABA-201 clinical trial costs;

Current wording

$4.0 million increase in clinical trial costs primarily due to CABA-201 clinical trial costs;

Previous wording

$2.2 million increase in manufacturing costs primarily due to cell processing capabilities and related activities; and a

Current wording

$2.9 million increase in manufacturing costs primarily due to cell processing capabilities and related activities; and a

Previous wording

$1.2 million increase in development services due to expanded lab space and related costs to support increased headcount performing research and translational activities.

Current wording

$0.9 million increase in development services due to expanded lab space and related costs to support increased headcount performing research and translational activities.

Previous wording

General and administrative expenses were $6.9 million for the three months ended June 30, 2024 compared to $4.1 million for the three months ended June 30, 2023. The increase of $2.8 million in our general and administrative expenses includes:

Current wording

General and administrative expenses were $6.8 million for the three months ended September 30, 2024 compared to $4.9 million for the three months ended September 30, 2023. The increase of $1.9 million in our general and administrative expenses includes:

Previous wording

$2.9 million of additional personnel costs, primarily driven by an increase in headcount to support overall company growth, including an increase of $1.6 million in stock-based compensation expense; and

Current wording

$1.6 million of additional personnel costs, primarily driven by an increase in headcount to support overall company growth, including an increase of $0.9 million in stock-based compensation expense; and

Previous wording

$1.0 million higher administrative costs, including legal, information technology and travel as well as other administrative costs.

Current wording

$0.3 million higher administrative costs, including legal, information technology and travel as well as other administrative costs.

Previous wording

Interest income increased by $1.2 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, primarily as a result earning interest on a higher cash, cash equivalents and investments balance due to the May 2023 financing and proceeds from sales of common stock pursuant to the 2023 ATM Program in the fourth quarter of 2023 and first quarter of 2024.

Current wording

Interest income increased by $0.2 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, primarily as a result earning interest on a higher cash, cash equivalents and investments balance due to the May 2023 financing and proceeds from sales of common stock pursuant to the 2023 ATM Program in the fourth quarter of 2023 and first quarter of 2024.

Previous wording

The following sets forth our results of operations for the six months ended June 30, 2024 and 2023:

Current wording

The following sets forth our results of operations for the nine months ended September 30, 2024 and 2023:

Previous wording

Research and development expenses were $45.4 million for the six months ended June 30, 2024 compared to $24.2 million for the six months ended June 30, 2023. The table below summarizes our research and development expenses:

Current wording

Research and development expenses were $71.7 million for the nine months ended September 30, 2024 compared to $38.0 million for the nine months ended September 30, 2023. The table below summarizes our research and development expenses:

Previous wording

$7.5 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our CARTA strategy, including an increase of $1.9 million in stock-based compensation expense;

Current wording

$12.1 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our CARTA strategy, including an increase of $3.3 million in stock-based compensation expense;

Previous wording

$7.0 million increase in clinical trial costs primarily due to CABA-201 clinical trial costs;

Current wording

$11.0 million increase in clinical trial costs primarily due to CABA-201 clinical trial costs;

Previous wording

$4.2 million increase in manufacturing costs primarily due to cell processing capabilities and related activities;

Current wording

$7.1 million increase in manufacturing costs primarily due to cell processing capabilities and related activities;

Previous wording

$2.7 million increase in development services due to expanded lab space and related costs to support increased headcount performing research and translational activities; partially offset by a

Current wording

$3.6 million increase in development services due to expanded lab space and related costs to support increased headcount performing research and translational activities; partially offset by a

Previous wording

$0.8 million decrease in license of intellectual property costs due to a $1.2 million upfront fee to Autolus pursuant to the Autolus Option and License Agreement and a $1.0 million milestone payment to IASO for IND clearance of CABA-201 in the first quarter of 2023 compared to a $1.5 million milestone payment to IASO in the first quarter of 2024 for the first patient dosed in the CABA-201 trial.

Current wording

$0.9 million decrease in license of intellectual property costs due to a $1.2 million upfront fee to Autolus pursuant to the Autolus Option and License Agreement and a $1.0 million milestone payment to IASO for IND clearance of CABA-201 in the first quarter of 2023 compared to a $1.5 million milestone payment to IASO in the first quarter of 2024 for the first patient dosed in the CABA-201 trial.

Previous wording

General and administrative expenses were $12.9 million for the six months ended June 30, 2024 compared to $8.6 million for the six months ended June 30, 2023. The increase of $4.3 million in our general and administrative expenses includes:

Current wording

General and administrative expenses were $19.7 million for the nine months ended September 30, 2024 compared to $13.5 million for the nine months ended September 30, 2023. The increase of $6.2 million in our general and administrative expenses includes:

Previous wording

$1.8 million of additional personnel costs, primarily driven by an increase in headcount to support overall company growth, including an increase of $1.0 million in stock-based compensation expense; and

Current wording

$4.5 million of additional personnel costs, primarily driven by an increase in headcount to support overall company growth, including an increase of $2.5 million in stock-based compensation expense; and

Previous wording

$1.4 million higher administrative costs, including legal, information technology and travel as well as other administrative costs.

Current wording

$1.7 million higher administrative costs, including legal, information technology and travel as well as other administrative costs.

Previous wording

Interest income increased by $3.2 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, primarily as a result of increasing interest rates on a higher cash, cash equivalents and investments balance due to financings in December 2022 and May 2023 and proceeds from sales of common stock pursuant to the 2023 ATM Program in the fourth quarter of 2023 and first quarter of 2024.

Current wording

Interest income increased by $3.4 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023, primarily as a result of increasing interest rates on a higher cash, cash equivalents and investments balance due to financings in December 2022 and May 2023 and proceeds from sales of common stock pursuant to the 2023 ATM Program in the fourth quarter of 2023 and first quarter of 2024.

Previous wording

From our inception in April 2017 to the time of our initial public offering, or IPO, our operations were financed by proceeds of $86.4 million from the sale of convertible notes and our convertible preferred stock and proceeds of $71.0 million from the sale of common stock in our IPO. Since our IPO, we have generated cash from public offerings of our common stock and pre-funded warrants to purchase our common stock resulting in aggregate net proceeds of approximately $280 million. As of June 30, 2024, we had $203.2 million in cash, cash equivalents and investments. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

Current wording

From our inception in April 2017 to the time of our initial public offering, or IPO, our operations were financed by proceeds of $86.4 million from the sale of convertible notes and our convertible preferred stock and proceeds of $71.0 million from the sale of common stock in our IPO. Since our IPO, we have generated cash from public offerings of our common stock and pre-funded warrants to purchase our common stock resulting in aggregate net proceeds of approximately $280 million. As of September 30, 2024, we had $183.0 million in cash, cash equivalents and investments. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

Previous wording

We have incurred losses since our inception and, as of June 30, 2024, we had an accumulated deficit of $285.9 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding prepaid expenses and other current assets, accounts payable and accrued expenses.

Current wording

We have incurred losses since our inception and, as of September 30, 2024, we had an accumulated deficit of $316.5 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding prepaid expenses and other current assets, accounts payable and accrued expenses.

Previous wording

In December 2022, we issued 126,815 shares of our common stock at a price of $5.52 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase 6,213,776 shares of our common stock at a price of $5.51999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.00001 per share exercise price of such pre-funded warrant. Aggregate net proceeds were $32.6 million after deducting underwriting discounts and commissions and offering expenses of $2.4 million. As of June 30, 2024, 5,045,722 pre-funded warrants had been exercised and 1,168,054 remain outstanding. An additional 543,380 pre-funded warrants were exercised subsequent to June 30, 2024.

Current wording

In December 2022, we issued 126,815 shares of our common stock at a price of $5.52 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase 6,213,776 shares of our common stock at a price of $5.51999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.00001 per share exercise price of such pre-funded warrant. Aggregate net proceeds were $32.6 million after deducting underwriting discounts and commissions and offering expenses of $2.4 million. As of September 30, 2024, 5,589,202 pre-funded warrants had been exercised and 624,574 remain outstanding. The remaining outstanding warrants were exercised subsequent to September 30, 2024. No warrants remain outstanding.

Previous wording

During the six months ended June 30, 2024, cash used in operating activities of $44.8 million was attributable to a net loss of $52.7 million and a net change of $4.2 million in our net operating assets and liabilities, partially offset by non-cash charges of $12.0 million primarily from stock-based compensation, non-cash lease expense and accretion of lease liabilities and depreciation.

Current wording

During the nine months ended September 30, 2024, cash used in operating activities of $65.1 million was attributable to a net loss of $83.3 million and a net change of $1.3 million in our net operating assets and liabilities, partially offset by non-cash charges of $19.5 million primarily from stock-based compensation, non-cash lease expense and accretion of lease liabilities and depreciation.

Previous wording

During the six months ended June 30, 2023, cash used in operating activities of $24.5 million was attributable to a net loss of $30.3 million and a decrease of $1.1 million in our net operating assets and liabilities, partially offset by a net change in non-cash charges of $6.9 million primarily from stock-based compensation, non-cash lease expense and accretion of lease liabilities and depreciation.

Current wording

During the nine months ended September 30, 2023, cash used in operating activities of $37.1 million was attributable to a net loss of $46.8 million and a decrease of $0.5 million in our net operating assets and liabilities, partially offset by a net change in non-cash charges of $10.2 million primarily from stock-based compensation, non-cash lease expense, accretion of lease liabilities and depreciation.

Previous wording

During the six months ended June 30, 2024, cash provided by investing activities of $22.9 million was attributable to $24.5 million from the maturity of short-term investments, partially offset by purchases of $1.6 million of property and equipment.

Current wording

During the nine months ended September 30, 2024, cash provided by investing activities of $35.2 million was attributable to $37.0 million from the maturity of short-term investments, partially offset by purchases of $1.8 million of property and equipment.

Previous wording

During the six months ended June 30, 2023, cash used in investing activities of $23.5 million was attributable to the purchases of $48.1 million of short-term investments and $0.4 million of property and equipment, partially offset by proceeds of $25.0 million from the maturity of short-term investments.

Current wording

During the nine months ended September 30, 2023, cash used in investing activities of $23.6 million was attributable to the purchases of $48.1 million of short-term investments and $0.5 million of property and equipment, partially offset by proceeds of $25.0 million from the maturity of short-term investments.

Previous wording

During the six months ended June 30, 2024, cash provided by financing activities of $7.2 million was from $5.7 million in sales of common stock, net of issuance costs paid, and $1.5 million from the exercise of employee stock options and purchases of shares under our 2019 Employee Stock Purchase Plan, or 2019 ESPP.

Current wording

During the nine months ended September 30, 2024, cash provided by financing activities of $7.3 million was from $5.7 million in sales of common stock, net of issuance costs paid, and $1.6 million from the exercise of employee stock options and purchases of shares under our 2019 Employee Stock Purchase Plan, or 2019 ESPP.

Previous wording

During the six months ended June 30, 2023, cash provided by financing activities of $94.5 million was primarily from net proceeds of $93.6 million from our underwritten public offerings and $0.9 million from the exercise of employee stock options and purchases of shares under our 2019 ESPP.

Current wording

During the nine months ended September 30, 2023, cash provided by financing activities of $94.6 million was primarily from net proceeds of $93.5 million from our underwritten public offerings and $1.1 million from the exercise of employee stock options and purchases of shares under our 2019 ESPP.