Keros Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
View on SEC.govAbout 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 7, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-08.
0001664710-24-000039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0001664710-24-000068
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 103 previous paragraphs and 111 current paragraphs.
74 unchanged; 25 reworded; 7 added; 4 removed; 0 previous and 5 current paragraphs rearranged.
Tables are not compared: 3 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 (7)
Current report
Preclinical Update
Current report
In July 2024, we presented one preclinical abstract on a research version of elritercept, RKER-050, one preclinical abstract on a research version of cibotercept, RKER-012, and three preclinical abstracts on KER-065 and a research version of KER-065, or RKER-065, at a Federation of American Societies for Experimental Biology science research conference on TGF-beta Superfamily. One such presentation further elucidated the binding affinity of KER-065 in preclinical head-to-head comparisons with other investigational therapeutic modalities that inhibit activins and/or myostatin. Such investigational therapeutic modalities included taldefgrobep and landogrozumab, which bind myostatin and GDF11, and bimagrumab, which binds and inhibits signaling by activins, myostatin, GDF11 and other members of the TGF-β superfamily via ActRIIA and ActRIIB. In these preclinical studies, KER-065 potently bound and inhibited activin A, activin B, myostatin and GDF11 and exhibited similar or greater potency than taldefgrobep, landogrozumab and bimagrumab, as applicable. Given that activin A and myostatin are key negative regulators of skeletal muscle growth, we believe KER-065 has the potential to offer improved benefit compared to modalities that block only myostatin or the activin receptors in the treatment of muscle wasting disorders or metabolic disorders.
Current report
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 report
Comparison for the six months ended June 30, 2024 and 2023
Current report
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
Current report
Revenue
Current report
Total Other Income, Net
Removed paragraphs (4)
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Reworded paragraphs (25)
Previous wording
Our lead product candidate, KER-050 (elritercept), 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. KER-050 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 December 2023, we announced additional data from our ongoing Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in patients with very low-, low-, or intermediate-risk MDS. We expect to report additional data from Part 2 of this trial in the second and fourth quarters of 2024. Additionally, we have engaged with the U.S. Food and Drug Administration regarding the design of the planned Phase 3 clinical trial of KER-050 in patients with MDS, and expect to provide an update on the planned trial design in mid-2024. Additionally, in December 2023, we announced additional data from our ongoing Phase 2 clinical trial evaluating KER-050 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 each of the second and 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 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.
Previous wording
Our second product candidate, KER-012 (cibotercept), 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 KER-012 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 KER-012 for the treatment of PAH and for the treatment of cardiovascular disorders. We expect to provide an update on enrollment for our ongoing Phase 2 clinical trial evaluating KER-012 in patients with PAH, which we refer to as the TROPOS trial, in the first half of 2024. We also expect to announce initial data from our ongoing open-label Phase 2 biomarker clinical trial of KER-012 in patients with chronic heart failure with preserved ejection fraction and in such patients with reduced ejection fraction in the second half 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. 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.
Previous wording
Our third product candidate, KER-065, is designed to bind to and inhibit TGF-ß ligands, including myostatin (GDF8) and activin A, which are negative regulators of muscle and bone mass and strength. Through inhibition of these TGF-ß ligands, we believe that KER-065 has the potential to increase skeletal muscle, increase energy expenditure, reduce body fat, improve insulin resistance and improve cardiac function. We are developing KER-065 for the treatment of obesity and for the treatment of neuromuscular disorders. Increased body adiposity, loss of skeletal muscle and bone loss are consequences of obesity. Significant loss of lean muscle mass has been associated with weight loss mediated by the class of glucagon-like pepetide-1 receptor agonists. We have commenced a Phase 1 clinical trial of KER-065 in a healthy volunteer adult population, and expect to announce initial data from this trial in the first quarter of 2025. Following the completion of this trial, we plan to initiate a proof-of-concept trial of KER-065 in obese patients.
Current wording
Our third product candidate, KER-065, is designed to bind to and inhibit TGF-ß ligands, including myostatin (GDF8) and activin A, which are negative regulators of muscle and bone mass and strength. Through inhibition of these TGF-ß ligands, we believe that KER-065 has the potential to increase skeletal muscle, increase energy expenditure, reduce body fat, improve insulin resistance and improve cardiac function. We are developing KER-065 for the treatment of obesity and for the treatment of neuromuscular diseases. Increased body adiposity, loss of skeletal muscle and bone loss are consequences of obesity. Significant loss of lean muscle mass has been associated with weight loss mediated by the class of glucagon-like pepetide-1 receptor agonists. We have commenced a Phase 1 clinical trial of KER-065 in a healthy volunteer adult population, and expect to announce initial data from this trial in the first quarter of 2025. Following the completion of this trial, we plan to initiate a proof-of-concept trial of KER-065 in obese patients.
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. 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 March 31, 2024, we have sold a total of 7,991,990 shares of our common stock pursuant to the ATM Offering for aggregate net proceeds of approximately$323.3 million after deducting sales agent commissions and estimated offering expenses. As of March 31, 2024, we may offer and sell ATM shares at an aggregate offering price of up to the remaining$71.5 million (less any sales agent commissions) available under the ATM Offering.
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
Previous wording
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 issuean unspecified amount of shares of our common stock, preferred stock, debt securities and warrants.
Current wording
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
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 $43.1 million for thethree months ended March 31, 2024, respectively. As of March 31, 2024, we had an accumulated deficit of $424.5 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 March 31, 2024, we had cash and cash equivalents of $442.4 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 $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.
Previous wording
On December 12, 2021, we entered into a license agreement with Hansoh (Shanghai) Healthtech Co., Ltd., or Hansoh. Under the terms of the license agreement with Hansoh, or the Hansoh Agreement, we granted to Hansoh the exclusive right to develop, manufacture and commercialize KER-050 and licensed products containing KER-050 within the territories of mainland China, Hong Kong and Macau, which we refer to collectively as the Territory.
Current wording
On December 12, 2021, we entered into a license agreement with Hansoh (Shanghai) Healthtech Co., Ltd., or Hansoh. Under the terms of the license agreement with Hansoh, or the Hansoh Agreement, we granted to Hansoh the exclusive right to develop, manufacture and commercialize elritercept and licensed products containing elritercept within the territories of mainland China, Hong Kong and Macau, which we refer to collectively as the Territory.
Previous wording
In connection with the Hansoh Agreement, Hansoh will purchase clinical trial supply of KER-050 from us, and the parties will also negotiate in good faith to enter into an agreement for commercial supply prior to any anticipated commercialization in the Territory. In addition, Hansoh will use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize licensed products in any region in the Territory.
Current wording
In connection with the Hansoh Agreement, Hansoh will purchase clinical trial supply of elritercept from us, and the parties will also negotiate in good faith to enter into an agreement for commercial supply prior to any anticipated commercialization in the Territory. In addition, Hansoh will use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize licensed products in any region in the Territory.
Previous wording
We recognized$0.1 million of service revenue related to the Hansoh Agreement for thethree months ended March 31, 2024. We did not recognize any revenue for thethree months ended March 31, 2023.
Current wording
We recognized$37.0 thousand of service revenue related to the Hansoh Agreement for thethree months ended June 30, 2024. We did not recognize any revenue for thethree months ended June 30, 2023.
Previous wording
Research and development expenses were $38.3 million for the three months ended March 31, 2024, compared to $31.1 million for the three months ended March 31, 2023. The increase of $7.2 million was primarily due to (i) an increase of $0.6 million of KER-012-related expenses, primarily driven by a net increase of $2.0 million in clinical spend associated with our ongoing Phase 2 clinical trial offset by a decrease of $1.4 million in manufacturing and preclinical activities; (ii) an increase of $3.4 million of KER-065-related expenses, primarily driven by a net increase of $2.8 million in manufacturing and preclinical activities and an increase of $0.6 million in clinical spend associated with our ongoing Phase 1 clinical trial; (iii) an increase of $0.3 million in preclinical pipeline and development activities; (iv) an increase of $3.8 million related to personnel expenses, which includes an increase of $1.2 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 $0.9 million in facilities, supplies, professional fees and other expenses due to the growth of our organization, partially offset by a decrease of $1.7 million of KER-050-related expenses, primarily driven by a decrease of $3.4 million in manufacturing activities and preclinical activities offset by an increase of $1.7 million in clinical spend associated with our ongoing Phase 2 clinical trials.
Current 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.
Previous wording
We began separately disclosing KER-065-related expenses in the second quarter of 2023 due to the planned advancement of KER-065 into the clinic and have updated the first quarter of 2023 research and development expense tables to separately disclose KER-065-related expenses in order to provide a meaningful comparison of the year-over-year expenses. We are no longer separately disclosing KER-047-related expenses in 2024 due to our decision to deprioritize the KER-047 program, and have updated prior period research and development expense tables to include KER-047-related expenses in preclinical expenses in order to provide a meaningful comparison of the year-over-year expenses. We expect research and development expenses to fluctuate from quarter to quarter depending on the timing of clinical trial activities, clinical manufacturing and other development activities.
Current wording
We are no longer separately disclosing KER-047-related expenses in 2024 due to our decision to deprioritize the KER-047 program, and have updated prior period research and development expense tables to include KER-047-related expenses in preclinical expenses in order to provide a meaningful comparison of the year-over-year expenses. We expect research and development expenses to fluctuate from quarter to quarter depending on the timing of clinical trial activities, clinical manufacturing and other development activities.
Previous wording
General and administrative expenses were $10.3 million for the three months ended March 31, 2024, compared to $7.8 million for the three months ended March 31, 2023. The increase of approximately $2.5 million was primarily due to (i) an increase of $1.6 million in personnel expenses, which includes an increase of$1.1 million of additional stock-based compensation costs to support our organizational growth and achievement of our corporate goals; and (ii) a net increase of $1.3 million in professional fees, facilities, supplies and other expenses to support the growth of our business, partially offset by a decrease of $0.3 million in directors and officers insurance premiums.
Current 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.
Previous wording
Total other income, net was $5.4 million for the three months ended March 31, 2024, comparedto $3.1 million for the three months ended March 31, 2023. The increase of $2.3 million was driven by an increase of $2.7 million in dividend income, partially offset by a decrease of $0.4 million in other expense, net.
Current 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.
Previous wording
Since our inception, we have incurred significant operating losses. Our net losses were $43.1 million and $35.8 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of $424.5 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 $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.
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. As of March 31, 2024, we sold a total of 7,991,990 shares of our common stock pursuant to the ATM Offering for aggregate net proceeds of approximately $323.3 million after deducting sales agent commissions and estimated offering expenses. During the three months ended March 31, 2024, we did not sell shares of our common stock pursuant to the ATM Offering. As of March 31, 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 $71.5 million available under 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.
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 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.
Previous wording
As of March 31, 2024, we had cash and cash equivalents of $442.4 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 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:
Previous wording
•the cost of manufacturing KER-050, KER-012, KER-065 and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;
Current wording
•the cost of manufacturing elritercept, cibotercept, KER-065 and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;
Previous wording
The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023 (in thousands):
Current wording
The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023 (in thousands):
Previous wording
Net cash used in operating activities was $44.6 million for the three months ended March 31, 2024, which was driven by a net loss of $43.1 million and $10.1 million in net cash used by operating assets and liabilities, partially offset by non-cash charges including $8.1 million of stock-based compensation expense, $0.3 million in lease expenses and $0.3 million in depreciation. The $10.1 million of net cash used in operating assets and liabilities was comprised of (i) $5.3 million used in accounts payable and accrued expenses to support the advancement of our programs; (ii) $4.5 million used in prepaid expenses and other assets due to timing of expense recognition for our research and development costs; (iii) $0.2 million used in our operating lease liabilities; and (iv) $0.1 million used in accounts receivable.
Current 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.
Previous wording
Net cash used in operating activities was $34.2 million for the three months ended March 31, 2023, which was driven by (i) a net loss of $35.8 million; and (ii) an increase of $4.8 million in net cash used in operating assets and liabilities, partially offset by non-cash charges of (a) $5.7 million of stock-based compensation expense; (b) $0.5 million in lease expenses; and (c) $0.2 million in depreciation. The $4.8 million of net cash used by operating assets and liabilities was primarily comprised of (i) $4.1 million used in prepaid expenses and other assets due to timing of expense recognition for our research and development costs; (ii) $0.7 million used in accounts payable and accrued expenses to support the advancement of our programs; and (iii) $0.1 million used in our operating lease liabilities.
Current 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.
Previous wording
Net cash used in investing activities was $0.9 million for the three months ended March 31, 2024 and $1.1 million for the three months ended March 31, 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 $1.3 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.
Previous wording
Net cash provided by financing activities was $156.8 million for the three months ended March 31, 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; and (ii) proceeds of $5.7 million related to exercises of options to purchase common stock.
Current 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.
Previous wording
Net cash provided by financing activities was $107.7 million for the three months ended March 31, 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 $0.4 million related to exercises of options to purchase common stock.
Current 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.
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.
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.
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 thethree months ended March 31, 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 six months ended June 30, 2024, there were no newly applicable recently issued accounting pronouncements.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
We recognized$0.1 million of service revenue related to the Hansoh Agreement for thesix months ended June 30, 2024. We did not recognize any revenue for thesix months ended June 30, 2023.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.