Keros Therapeutics Inc

Previous wording

Our lead product candidate, elritercept (KER-050), is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß superfamily receptor known as activin receptor type IIA, or ActRIIA, that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes, or MDS, and in patients with myelofibrosis. In June 2024, we announced additional data from our ongoing Phase 2 clinical trial evaluating elritercept for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk MDS, which we refer to as lower-risk MDS. We expect to report additional data from Part 2 of this trial in the fourth quarter of 2024. Additionally, we received positive feedback from the U.S. Food and Drug Administration regarding the elritercept MDS program, which resulted in general alignment on the design and endpoints for the proposed pivotal, placebo-controlled Phase 3 clinical trial in patients with lower-risk MDS. We expect to provide additional details on the planned trial design in the second half of 2024. Additionally, in June 2024, we announced additional data from our ongoing Phase 2 clinical trial evaluating elritercept for the treatment of patients with myelofibrosis-associated cytopenias, which we refer to as the RESTORE trial. We expect to announce additional data from this trial in the fourth quarter of 2024.

Current wording

Our lead product candidate, elritercept (KER-050), is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß superfamily receptor known as activin receptor type IIA, or ActRIIA, that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes, or MDS, and in patients with myelofibrosis. In June 2024, we announced additional data from our ongoing Phase 2 clinical trial evaluating elritercept for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk MDS, which we refer to as lower-risk MDS. We expect to report additional data from Part 2 of this trial in the fourth quarter of 2024. Additionally, we received positive feedback from the U.S. Food and Drug Administration regarding the elritercept MDS program, which resulted in general alignment on the design and endpoints for the proposed pivotal, placebo-controlled Phase 3 clinical trial in patients with lower-risk MDS. We expect to provide additional details on the planned trial design in the fourth quarter of 2024. Additionally, in June 2024, we announced additional data from our ongoing Phase 2 clinical trial evaluating elritercept for the treatment of patients with myelofibrosis-associated cytopenias, which we refer to as the RESTORE trial. We expect to announce additional data from the RESTORE trial in the fourth quarter of 2024.

Previous wording

Our second product candidate, cibotercept (KER-012), is designed to bind to and inhibit the signaling of TGF-ß ligands that stimulate the proliferation of vascular endothelial and smooth muscle cells and fibroblasts, including activin A, activin B and myostatin (GDF8). We believe that cibotercept has the potential to increase the signaling of bone morphogenic protein, or BMP, pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as pulmonary arterial hypertension, or PAH, that are associated with reduced BMP signaling, including inactivating mutations in the BMP receptors. We are developing cibotercept for the treatment of PAH and for the treatment of cardiovascular disorders. We expect to complete enrollment of our ongoing Phase 2 clinical trial evaluating cibotercept in patients with PAH, which we refer to as the TROPOS trial, in the fourth quarter of 2024.

Current wording

Our second product candidate, cibotercept (KER-012), is designed to bind to and inhibit the signaling of TGF-ß ligands that stimulate the proliferation of vascular endothelial and smooth muscle cells and fibroblasts, including activin A, activin B and myostatin (GDF8). We believe that cibotercept has the potential to increase the signaling of bone morphogenic protein, or BMP, pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as pulmonary arterial hypertension, or PAH, that are associated with reduced BMP signaling, including inactivating mutations in the BMP receptors. We are developing cibotercept for the treatment of PAH and for the treatment of cardiovascular disorders. In September 2024, we announced completion of enrollment of our ongoing Phase 2 clinical trial evaluating cibotercept in patients with PAH, which we refer to as the TROPOS trial. We expect to present topline data from the TROPOS trial in the second quarter of 2025.

Previous wording

In May 2021, we entered into a Sales Agreement with Leerink Partners LLC, or Leerink, as sales agent, which we refer to as the ATM Sales Agreement, under which we may offer and sell, from time to time, shares of our common stock, or the ATM Shares, through Leerink, which we refer to as the ATM Offering. In May 2021, we filed a registration statement on Form S-3, which we refer to as the Prior Shelf Registration Statement, including a base prospectus and sales agreement prospectus, with the SEC, which became effective immediately upon filing, for the issuance and sale of up to$150.0 million of shares of our common stock under the ATM Sales Agreement. In December 2022, we filed a prospectus supplement to the Prior Shelf Registration Statement for the issuance and sale, if any, of up to an additional $250.0 million of shares of our common stock under the ATM Sales Agreement. In May 2024, we filed a new registration statement on Form S-3, which we refer to as the

Current wording

In May 2021, we entered into a Sales Agreement with Leerink Partners LLC, or Leerink, as sales agent, which we refer to as the ATM Sales Agreement, under which we may offer and sell, from time to time, shares of our common stock, or the ATM Shares, through Leerink, which we refer to as the ATM Offering. In May 2021, we filed a registration statement on Form S-3, which we refer to as the Prior Shelf Registration Statement, including a base prospectus and sales agreement prospectus, with the SEC, which became effective immediately upon filing, for the issuance and sale of up to$150.0 million of shares of our common stock under the ATM Sales Agreement. In December 2022, we filed a prospectus supplement to the Prior Shelf Registration Statement for the issuance and sale, if any, of up to an additional $250.0 million of shares of our common stock under the ATM Sales Agreement. In May 2024, we filed a new registration statement on Form S-3, which we refer to as the New Shelf Registration Statement, to replace the Prior Shelf Registration Statement that was set to expire, including a base prospectus, which became effective immediately upon filing, under which we could issue an unspecified amount of shares of our common stock, preferred stock, debt securities and warrants. In June 2024, we filed a prospectus supplement to the New Shelf Registration Statement for the issuance and sale, if any, of up to an additional $350.0 million of shares of our common stock under the ATM Sales Agreement.

Previous wording

Under the ATM Sales Agreement, Leerink may sell the ATM Shares by methods deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) promulgated under the Securities Exchange Act of 1934, as amended. We may sell the ATM Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the ATM Sales Agreement, but we have no obligation to sell any of the ATM Shares in the ATM Offering. As of June 30, 2024, we have sold a total of 14,068 shares of our common stock pursuant to the ATM Offering for aggregate net proceeds of approximately$0.5 million after deducting sales agent commissions and estimated offering expenses. As of June 30, 2024, we may offer and sell ATM shares at an aggregate offering price of up to the remaining$349.4 million (less any sales agent commissions) available under the ATM Offering.

Current wording

Under the ATM Sales Agreement, Leerink may sell the ATM Shares by methods deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) promulgated under the Securities Exchange Act of 1934, as amended. We may sell the ATM Shares in amounts and at times to be determined by us from time to time subject to the terms and conditions of the ATM Sales Agreement, but we have no obligation to sell any of the ATM Shares in the ATM Offering. As of September 30, 2024, we have sold a total of 3,059,830 shares of our common stock pursuant to the ATM Offering for aggregate net proceeds of approximately$155.5 million after deducting sales agent commissions and estimated offering expenses. As of September 30, 2024, we may offer and sell ATM shares at an aggregate offering price of up to the remaining$191.9 million (less any sales agent commissions) available under the ATM Offering.

Previous wording

We have incurred recurring operating losses since inception in 2015. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Our net loss was $45.3 million and$88.4 million for thethree and six months ended June 30, 2024, respectively. As of June 30, 2024, we had an accumulated deficit of $469.8 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future in connection with our ongoing activities. As of June 30, 2024, we had cash and cash equivalents of $405.9 million.

Current wording

We have incurred recurring operating losses since inception in 2015. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of one or more of our product candidates. Our net loss was $53.0 million and$141.3 million for thethree and nine months ended September 30, 2024, respectively. As of September 30, 2024, we had an accumulated deficit of $522.8 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future in connection with our ongoing activities. As of September 30, 2024, we had cash and cash equivalents of $530.7 million.

Previous wording

Under the terms of the MGH Agreement, we made an initial license payment of $0.1 million in 2016 and reimbursed MGH approximately $0.3 million of prior patent prosecution expenses related to the licensed patents in 2017. We also issued MGH an aggregate of 358,674 shares of our common stock. Additionally, we are required to pay a nominal annual maintenance fee prior to the first commercial sale of our first product or process, a mid-five digit annual maintenance fee after the first commercial sale of our first product or process that is creditable against royalties, certain clinical and regulatory milestone payments for the first three products or indications to achieve such milestones, which milestone payments are $8.6 million in the aggregate, and certain commercial milestone payments for the first three products or indications to achieve such milestones, which milestone payments are $18.0 million in the aggregate. We made payments of $50,000 and $300,000 in 2020 and 2021, respectively, for the achievement of the clinical and regulatory milestones of (i) filing of an IND in the first country and (ii) the completion of a Phase 1 clinical trial, respectively. We are also obligated to pay tiered royalties on net sales of licensed products ranging in the low-single digits to mid-single digits. The royalty rates are subject to up to a maximum 50% reduction for lack of a valid claim, in the event that it is necessary for us to obtain a license to any third-party intellectual property related to the licensed products, and generic competition. The obligation to pay royalties under the MGH Agreement expires on a licensed product-by-licensed product and country-by-country basis upon the later of expiry of the last valid claim of the licensed patents that cover such licensed product in such country and ten years from the first commercial sale of such product in such country. We are also obligated to pay a percentage of non-royalty-related payments received by us from sublicensees ranging in the sub-teen double digits and a change of control fee equal to a low-single digit percentage of the payments received as part of any completed transaction up to a low-seven digit amount.

Current wording

2020 and 2021, respectively, for the achievement of the clinical and regulatory milestones of (i) filing of an IND in the first country and (ii) the completion of a Phase 1 clinical trial, respectively. We are also obligated to pay tiered royalties on net sales of licensed products ranging in the low-single digits to mid-single digits. The royalty rates are subject to up to a maximum 50% reduction for lack of a valid claim, in the event that it is necessary for us to obtain a license to any third-party intellectual property related to the licensed products, and generic competition. The obligation to pay royalties under the MGH Agreement expires on a licensed product-by-licensed product and country-by-country basis upon the later of expiry of the last valid claim of the licensed patents that cover such licensed product in such country and ten years from the first commercial sale of such product in such country. We are also obligated to pay a percentage of non-royalty-related payments received by us from sublicensees ranging in the sub-teen double digits and a change of control fee equal to a low-single digit percentage of the payments received as part of any completed transaction up to a low-seven digit amount.

Previous wording

Research and development expenses were $40.5 million for the three months ended June 30, 2024, compared to $32.5 million for the three months ended June 30, 2023. The increase of $8.0 million was primarily due to (i) an increase of $1.7 million of elritercept-related expenses, primarily driven by an increase of $2.5 million in clinical spend associated with our ongoing Phase 2 clinical trials offset by a decrease of $0.8 million in manufacturing and preclinical activities; (ii) an increase of $0.2 million of cibotercept-related expenses, primarily driven by a net increase of $1.8 million in clinical spend associated with our ongoing Phase 2 clinical trial offset by a decrease of $1.6 million in manufacturing and preclinical activities; (iii) an increase of $1.8 million of KER-065-related expenses, primarily driven by a net increase of $1.3 million in clinical spend associated with our ongoing Phase 1 clinical trial and an increase of $0.5 million in manufacturing and preclinical activities; (iv) an increase of $0.5 million in preclinical pipeline and development activities; (v) an increase of $3.4 million related to personnel expenses, which includes an increase of $1.3 million of additional stock-based compensation costs, primarily driven by increased headcount to support the advancement of our pipeline; and (vi) a net increase of $0.4 million in facilities, supplies, professional fees and other expenses due to the growth of our organization.

Current wording

Research and development expenses were $49.2 million for the three months ended September 30, 2024, compared to $34.1 million for the three months ended September 30, 2023. The increase of $15.1 million was primarily due to (i) an increase of $4.1 million of elritercept-related expenses, primarily driven by an increase of $3.1 million in clinical spend associated with our ongoing Phase 2 clinical trials and planned Phase 3 clinical trial, and an increase of $1.0 million in manufacturing and preclinical activities; (ii) an increase of $3.3 million of cibotercept-related expenses, primarily driven by a net increase of $2.5 million in clinical spend associated with our ongoing Phase 2 clinical trial and an increase of $0.8 million in manufacturing and preclinical activities; (iii) an increase of $3.8 million of KER-065-related expenses, primarily driven by a net increase of $2.2 million in manufacturing and preclinical activities and an increase of $1.6 million in clinical spend associated with our ongoing Phase 1 clinical trial; (iv) an increase of $1.2 million in preclinical pipeline and development activities; (v) an increase of $1.5 million related to personnel expenses, primarily driven by increased headcount to support the advancement of our pipeline; and (vi) a net increase of $1.3 million in facilities, supplies, professional fees and other expenses due to the growth of our organization.

Previous wording

General and administrative expenses were $10.0 million for the three months ended June 30, 2024, compared to $8.8 million for the three months ended June 30, 2023. The increase of approximately $1.2 million was primarily due to (i) an increase of $0.9 million in personnel expenses, which includes an increase of$0.5 million of additional stock-based compensation costs to support our organizational growth and achievement of our corporate goals; and (ii) a net increase of $0.5 million in professional fees, facilities, supplies and other expenses to support the growth of our business, partially offset by a decrease of $0.2 million in directors and officers insurance premiums.

Current wording

General and administrative expenses were $9.8 million for the three months ended September 30, 2024, compared to $9.1 million for the three months ended September 30, 2023. The increase of approximately $0.7 million was primarily due to (i) an increase of $0.6 million in personnel expenses, which includes an increase of$0.2 million of additional stock-based compensation costs to support our organizational growth and achievement of our corporate goals; and (ii) a net increase of $0.1 million in professional fees, facilities, supplies and other expenses to support the growth of our business.

Previous wording

Total other income, net was $5.2 million for the three months ended June 30, 2024, comparedto $3.8 million for the three months ended June 30, 2023. The increase of $1.4 million was driven by an increase in dividend income.

Current wording

Total other income, net was $5.7 million for the three months ended September 30, 2024, comparedto $3.8 million for the three months ended September 30, 2023. The increase of $1.9 million was driven by an increase in dividend income.

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

Research and development expenses were $78.8 million for the six months ended June 30, 2024, compared to $63.6 million for the six months ended June 30, 2023. The increase of $15.1 million was primarily due to (i) an increase of $0.8 million of cibotercept-related expenses, driven by an increase of $3.8 million in clinical spend associated with our ongoing Phase 2 clinical trial offset by a decrease of $3.0 million in manufacturing and preclinical activities; (ii) an increase of $5.1 million of KER-065-related expenses, primarily driven by a net increase of $3.3 million in manufacturing and preclinical activities and an increase of $1.8 million in clinical spend associated with our ongoing Phase 1 clinical trial; (iii) an increase of $0.7 million in preclinical and development fees related to general pipeline development; (iv) an increase of $7.2 million related to personnel expenses, which includes an increase of $2.5 million of additional stock-based compensation costs, primarily driven by increased headcount to support the advancement of our pipeline; and (v) a net increase of $1.3 million in facilities, supplies, professional fees and other expenses due to the growth of our organization, partially offset by a decrease of $0.1 million in elritercept-related expenses, primarily driven by a net $4.2 million decrease in manufacturing and preclinical activities offset by a $4.1 million increase in clinical spend associated with our ongoing Phase 2 clinical trials.

Current wording

Research and development expenses were $128.0 million for the nine months ended September 30, 2024, compared to $97.8 million for the nine months ended September 30, 2023. The increase of $30.2 million was primarily due to (i) an increase of $4.1 million in elritercept-related expenses, primarily driven by an increase of $7.3 million in clinical spend associated with our ongoing Phase 2 clinical trials and planned Phase 3 clinical trial, partially offset by a decrease of $3.2 million in manufacturing and preclinical activities; (ii) an increase of $4.1 million of cibotercept-related expenses, driven by an increase of $6.3 million in clinical spend associated with our ongoing Phase 2 clinical trial, partially offset by a decrease of $2.2 million in manufacturing and preclinical activities; (iii) an increase of $8.9 million of KER-065-related expenses, primarily driven by a net increase of $5.4 million in manufacturing and preclinical activities and an increase of $3.5 million in clinical spend associated with our ongoing Phase 1 clinical trial; (iv) an increase of $1.9 million in preclinical and development fees related to general pipeline development; (v) an increase of $8.7 million related to personnel expenses, which includes an increase of $2.5 million of additional stock-based compensation costs, primarily driven by increased headcount to support the advancement of our pipeline; and (vi) a net increase of $2.6 million in facilities, supplies, professional fees and other expenses due to the growth of our organization.

Previous wording

General and administrative expenses were $20.3 million for the six months ended June 30, 2024, compared to $16.6 million for the six months ended June 30, 2023. The increase of approximately $3.7 million was primarily due to (i) an increase of $2.5 million in personnel expenses, which includes an increase of $1.6 million additional stock-based compensation costs, to support our organizational growth and achievement of our corporate goals; and (ii) a net increase of $1.7 million in professional fees, facilities, supplies and other expenses to support the growth of our business, partially offset by a decrease of $0.5 million in directors and officers insurance premiums.

Current wording

General and administrative expenses were $30.1 million for the nine months ended September 30, 2024, compared to $25.7 million for the nine months ended September 30, 2023. The increase of approximately $4.4 million was primarily due to (i) an increase of $3.1 million in personnel expenses, which includes an increase of $1.8 million additional stock-based compensation costs, to support our organizational growth and achievement of our corporate goals; and (ii) a net increase of $1.9 million in professional fees, facilities, supplies and other expenses to support the growth of our business, partially offset by a decrease of $0.6 million in directors and officers insurance premiums.

Previous wording

Total other income, net was$10.6 million for thesix months ended June 30, 2024, comparedto $6.9 million for the six months ended June 30, 2023. The increase of approximately $3.7 million was driven by an increase of $4.1 million in dividend income, partially offset by an increase of $0.4 million in other expense, net.

Current wording

Total other income, net was$16.3 million for thenine months ended September 30, 2024, comparedto $10.7 million for the nine months ended September 30, 2023. The increase of approximately $5.5 million was driven by an increase of $6.0 million in dividend income, partially offset by an increase of $0.5 million in other expense, net.

Previous wording

Since our inception, we have incurred significant operating losses. Our net losses were $88.4 million and $73.3 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024 and December 31, 2023, we had an accumulated deficit of $469.8 million and $381.4 million, respectively. To date, we have devoted the majority of our efforts into business planning, research and development of our product candidates, including by conducting clinical trials and preclinical studies, raising capital and recruiting management and technical staff to support these operations. Our primary uses of cash are to fund operating expenses, which are primarily research and development expenditures. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical studies and clinical trials of our product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, director and officer insurance premiums and other expenses. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to establishing sales, marketing, distribution and other commercial infrastructure to commercialize such products.

Current wording

Since our inception, we have incurred significant operating losses. Our net losses were $141.3 million and $112.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $522.8 million and $381.4 million, respectively. To date, we have devoted the majority of our efforts into business planning, research and development of our product candidates, including by conducting clinical trials and preclinical studies, raising capital and recruiting management and technical staff to support these operations. Our primary uses of cash are to fund operating expenses, which are primarily research and development expenditures. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical studies and clinical trials of our product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, director and officer insurance premiums and other expenses. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to establishing sales, marketing, distribution and other commercial infrastructure to commercialize such products.

Previous wording

On May 3, 2021, we filed the Prior Shelf Registration Statement, which permitted us to offer, from time to time, an unspecified amount of common stock, preferred stock, debt securities and warrants. We simultaneously entered into the ATM Sales Agreement with Leerink, as agent, to provide for the issuance and sale by us of the ATM Shares from time to time in “at-the-market” offerings under the Prior Shelf Registration Statement, which we refer to as the ATM Program. On May 3, 2024, we filed the New Shelf Registration Statement to replace the Prior Shelf Registration Statement, which permits us to offer, from time to time, an unspecified amount of common stock, preferred stock, debt securities and warrants. During the six months ended June 30, 2024, we sold 14,068 shares of our common stock pursuant to the ATM Offering. As of June 30, 2024, we were eligible to offer and sell, from time to time, shares of our common stock for an aggregate offering amount of up to the remaining $349.4 million available under the ATM Program.

Current wording

On May 3, 2021, we filed the Prior Shelf Registration Statement, which permitted us to offer, from time to time, an unspecified amount of common stock, preferred stock, debt securities and warrants. We simultaneously entered into the ATM Sales Agreement with Leerink, as agent, to provide for the issuance and sale by us of the ATM Shares from time to time in “at-the-market” offerings under the Prior Shelf Registration Statement, which we refer to as the ATM Program. On May 3, 2024, we filed the New Shelf Registration Statement to replace the Prior Shelf Registration Statement, which permits us to offer, from time to time, an unspecified amount of common stock, preferred stock, debt securities and warrants. During the nine months ended September 30, 2024, we sold 3,059,830 shares of our common stock pursuant to the ATM Offering. As of September 30, 2024, we were eligible to offer and sell, from time to time, shares of our common stock for an aggregate offering amount of up to the remaining $191.9 million available under the ATM Program.

Previous wording

As of June 30, 2024, we had cash and cash equivalents of $405.9 million. We believe that our existing cash and cash equivalents will be sufficient to fund our projected liquidity requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Due to the numerous risks and uncertainties associated with the development of our product candidates and programs, and because the extent to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our future funding requirements, both near and long-term, will depend on many factors, including:

Current wording

As of September 30, 2024, we had cash and cash equivalents of $530.7 million. We believe that our existing cash and cash equivalents will be sufficient to fund our projected liquidity requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Due to the numerous risks and uncertainties associated with the development of our product candidates and programs, and because the extent to which we may enter into collaborations with third parties for development of our product candidates is unknown, we are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our future funding requirements, both near and long-term, will depend on many factors, including:

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

Net cash used in operating activities was $84.4 million for the six months ended June 30, 2024, which was driven by a net loss of $88.4 million and $14.1 million in net cash used by operating assets and liabilities, partially offset by non-cash charges including $16.9 million of stock-based compensation expense, $0.7 million in lease expenses and $0.6 million in depreciation. The $14.1 million of net cash used in operating assets and liabilities was comprised of (i) $10.8 million used in prepaid expenses and other assets due to timing of expense recognition for our research and development costs; (ii) $2.8 million used in accounts payable and accrued expenses to support the advancement of our programs; (iii) $0.6 million used in our operating lease liabilities; and (iv) offset by a $0.1 million decrease in accounts receivable.

Current wording

Net cash used in operating activities was $114.9 million for the nine months ended September 30, 2024, which was driven by a net loss of $141.3 million and $1.4 million in net cash used by operating assets and liabilities, partially offset by non-cash charges including $25.7 million of stock-based compensation expense, $1.2 million in lease expenses and $0.9 million in depreciation. The $1.4 million of net cash used in operating assets and liabilities was comprised of (i) $5.0 million used in prepaid expenses and other current assets due to timing of expense recognition for our research and development costs; (ii) a $0.9 million change in our operating lease liabilities; (iii) $0.2 million increase in accounts receivable; offset by (a) $4.3 million increase in accounts payable and accrued expenses to support the advancement of our programs; and (b) $0.5 million decrease in other long-term assets.

Previous wording

Net cash used in operating activities was $65.1 million for the six months ended June 30, 2023, which was driven by (i) a net loss of $73.3 million; and (ii) an increase of $5.7 million in net cash used in operating assets and liabilities, partially offset by non-cash charges of (a) $12.7 million of stock-based compensation expense; (b) $0.9 million in lease expenses; and (c) $0.4 million in depreciation. The $5.7 million of net cash used by operating assets and liabilities was primarily comprised of (i) $5.6 million used in prepaid expenses and other assets due to timing of expense recognition for our research and development costs; and (ii) $0.1 million used in our operating lease liabilities.

Current wording

Net cash used in operating activities was $99.0 million for the nine months ended September 30, 2023, which was driven by (i) a net loss of $112.7 million; and (ii) an increase of $9.5 million in net cash used in operating assets and liabilities, partially offset by non-cash charges of (a) $21.4 million of stock-based compensation expense; (b) $1.2 million in lease expenses; and (c) $0.6 million in depreciation. The $9.5 million of net cash used by operating assets and liabilities was primarily comprised of (i) $9.8 million used in prepaid expenses and other assets due to timing of expense recognition for our research and development costs; and (ii) $0.3 million used in our operating lease liabilities.

Previous wording

Net cash used in investing activities was $1.3 million for the six months ended June 30, 2024 and $1.4 million for the six months ended June 30, 2023. The cash used in investing activities in both periods was due to purchases of property and equipment.

Current wording

Net cash used in investing activities was $1.6 million for the nine months ended September 30, 2024 and $1.9 million for the nine months ended September 30, 2023. The cash used in investing activities in both periods was due to purchases of property and equipment.

Previous wording

Net cash provided by financing activities was $160.3 million for the six months ended June 30, 2024, which was primarily related to (i) net proceeds of $151.1 million received from our public offering of common stock in January 2024, after deducting underwriting discounts, commissions and offering expenses; (ii) net proceeds of $0.6 million received from sale of our common stock under the ATM Program, after deducting sales agent commissions and offering expense; and (iii) proceeds of $8.7 million related to exercises of options to purchase common stock.

Current wording

Net cash provided by financing activities was $316.3 million for the nine months ended September 30, 2024, which was primarily related to (i) net proceeds of $151.1 million received from our public offering of common stock in January 2024, after deducting underwriting discounts, commissions and offering expenses; (ii) net proceeds of $155.5 million received from sale of our common stock under the ATM Program, after deducting sales agent commissions and offering expense; and (iii) proceeds of $9.7 million related to exercises of options to purchase common stock.

Previous wording

Net cash provided by financing activities was $109.4 million for the six months ended June 30, 2023, which was primarily related to (i) net proceeds of $107.3 million received from sales of our common stock under the ATM Program, after deducting sales agent commissions and offering expenses; and (ii) proceeds of $2.1 million related to exercises of options to purchase common stock.

Current wording

Net cash provided by financing activities was $109.7 million for the nine months ended September 30, 2023, which was primarily related to (i) net proceeds of $107.3 million received from sales of our common stock under the ATM Program, after deducting sales agent commissions and offering expenses; and (ii) proceeds of $2.4 million related to exercises of options to purchase common stock.

Previous wording

Refer to Note 2 in the accompanying notes to our unaudited interim condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements. In the six months ended June 30, 2024, there were no newly applicable recently issued accounting pronouncements.

Current wording

Refer to Note 2 in the accompanying notes to our unaudited interim condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements. In the nine months ended September 30, 2024, there were no newly applicable recently issued accounting pronouncements.