Beam Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 5, 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.
Sep 30, 2024 · Filed Nov 5, 2024
BEAM$26.41+2.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0000950170-24-091242
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-05.
0000950170-24-121104
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 185 previous paragraphs and 196 current paragraphs.
128 unchanged; 46 reworded; 21 added; 10 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
On November 5, 2024, we announced the publication of an abstract for an upcoming oral presentation at the American Society of Hematology Annual Meeting and Exposition taking place December 7-10, 2024 in San Diego, CA, or ASH. The abstract contained initial, preliminary data as of July 2, 2024 from the BEACON trial, including adverse event, or AE, data from six patients, as well as engraftment and efficacy data from four patients with at least one month of follow-up post-dosing. The abstract data included the following:
Current report
The initial safety profile of BEAM-101 was consistent with busulfan conditioning and autologous HSCT.
Current report
There were no ≥Grade 3 AEs or serious AEs determined to be related to treatment with BEAM-101.
Current report
One patient died four months after BEAM-101 infusion due to respiratory failure that was determined by the investigator to be likely related to busulfan conditioning and deemed unrelated to BEAM-101.
Current report
Patients achieved neutrophil and platelet engraftment at a median of 17 (15–19) and 20 (11–34) days, respectively.
Current report
All four patients with at least one month of follow-up experienced rapid and robust HbF induction by month one (>60%) and corresponding HbS reduction (≤36%) in non-transfused blood, which was sustained over time.
Current report
No vaso-occlusive crises (VOCs) were reported by investigators post-treatment.
Current report
We expect to present additional data on a total of seven patients from the BEACON trial at ASH.
Current report
We have nominated a development candidate for our ESCAPE technology comprised of two investigational drug products: BEAM-103, an anti-CD117 monoclonal antibody, and BEAM-104, a cell therapy that includes the same therapeutic edit as BEAM-101 (editing the HBG1/2 genes to elevate fetal hemoglobin), plus an additional edit to CD117 designed to block binding of BEAM-103, allowing the edited cells to evade suppression by the antibody. We intend to advance BEAM-103 and BEAM-104 for development in sickle cell disease and beta-thalassemia, potentially building on the same regulatory, manufacturing, clinical and commercial foundations being established with BEAM-101. We anticipate initiating Phase 1-enabling preclinical studies for ESCAPE by the end of 2024.
Current report
On November 5, 2024, we announced the publication of an abstract for an upcoming oral presentation at ASH containing data from a preclinical study of our ESCAPE approach in non-human primates, or NHPs. Initial data from two NHPs undergoing autologous HSCT after conditioning with a CD117 antibody showed robust long-term engraftment and high levels of HbF expression forex vivo edited CD34 cells, establishing preclinical proof of principle for the ESCAPE approach. We expect to provide additional data from the study at ASH.
Current report
On November 5, 2024, we announced the publication of an abstract for an upcoming poster presentation at ASH containing initial, preliminary data from three patients in the BEAM-201 clinical trial. The data showed a safety profile consistent with underlying disease, lymphodepletion and AEs associated with CAR-T therapy. A complete response (CRi/CR) was demonstrated in two of three patients at CAR-T cell doses greater than 200 million. Both patients achieving a CRi/CR were deemed suitable for stem cell transplant following therapy. We expect to present additional data from the BEAM-201 clinical trial at ASH.
Current report
The decrease of $5.8 million was primarily due to the following:
Current report
A decrease in other expenses of $1.3 million driven by lower sublicense expenses related to our collaborations during the three months ended September 30, 2024.
Current report
An increase of $0.6 million in stock-based compensation from additional equity awards granted to employees;
Current report
A decrease of $0.9 million in facility and IT allocated costs, including depreciation, due to the expense allocated to general and administrative expenses related to our leased facilities; and
Current report
A decrease of $0.3 million in other expenses.
Current report
Comparison of the nine months ended September 30, 2024 and 2023
Current report
The decrease of $31.2 million was primarily due to the following:
Current report
An increase of $9.8 million in stock-based compensation from additional equity awards granted to employees; and
Current report
An increase of $4.6 million in stock-based compensation from additional equity awards granted to employees;
Current report
A decrease of $0.1 million in other expenses during the nine months ended September 30, 2024 compared to September 30, 2023.
Removed paragraphs (10)
Previous report
In May 2024, we announced that the three patients in the sentinel cohort of the BEACON trial have each been dosed and successfully achieved engraftment. Following engraftment of the third patient, we have dosed three patients in the expansion phase of the trial. To date more than twenty patients have cleared screening and enrolled in the trial. We expect to report data on all patients from the sentinel cohort as well as multiple patients from the expansion cohort in the fourth quarter of 2024.
Previous report
The decrease of $10.6 million was primarily due to the following:
Previous report
An increase in other expenses of $1.5 million, due primarily to fees for milestones achieved during the three months ended June 30, 2024.
Previous report
An increase of $2.0 million in stock-based compensation from additional equity awards granted to employees;
Previous report
Comparison of the six months ended June 30, 2024 and 2023
Previous report
The decrease of $25.4 million was primarily due to the following:
Previous report
An increase of $6.7 million in stock-based compensation from additional equity awards granted to employees;
Previous report
An increase in other expenses of $1.2 million, driven primarily by fees associated with milestones achieved during the six months ended June 30, 2024.
Previous report
An increase of $4.0 million in stock-based compensation from additional equity awards granted to employees;
Previous report
the actual savings or benefits we realize from our recent portfolio prioritization and strategic restructuring;
Reworded paragraphs (46)
Previous wording
We are using base editing to pursue the development of BEAM-101 for the treatment of sickle cell disease and beta-thalassemia. BEAM-101 is a patient-specific, autologous HSC investigational therapy designed to offer a potentially best-in-class profile, incorporating base edits that are intended to mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin, or HbF. BEAM-101 aims to alleviate the effects of sickle cell disease or beta-thalassemia by increasing HbF, which is expected to increase functional hemoglobin production and, in the case of sickle cell disease, inhibit hemoglobin S, or HbS, polymerization.
Current wording
We are using base editing to pursue the development of BEAM-101 for the treatment of sickle cell disease. BEAM-101 is a patient-specific, autologous HSC investigational therapy designed to offer a potentially best-in-class profile, incorporating base edits that are intended to mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin, or HbF. BEAM-101 aims to alleviate the effects of sickle cell disease by increasing HbF, which is expected to increase functional hemoglobin production and, in the case of sickle cell disease, inhibit hemoglobin S, or HbS, polymerization.
Previous wording
We are conducting a Phase 1/2 clinical trial designed to assess the safety and efficacy of BEAM-101 for the treatment of sickle cell disease, which we refer to as our BEACON trial. The BEACON trial includes an initial “sentinel” cohort of three patients, treated one at a time to confirm successful engraftment, followed by dosing in up to a total of 45 patients. The clinical trial initially includes patients ages 18 to 35 with severe sickle cell disease who have received prior treatment with at least one disease-modifying agent with inadequate response or intolerance. Following mobilization, conditioning and treatment with BEAM-101, patients are assessed for safety and tolerability, with safety endpoints including neutrophil and platelet engraftment. Patients are also assessed for efficacy, with efficacy endpoints including the change from baseline in severe vaso-occlusive events, transfusion requirements, HbF levels, and quality of life assessments.
Current wording
We are conducting a Phase 1/2 clinical trial designed to assess the safety and efficacy of BEAM-101 for the treatment of sickle cell disease, which we refer to as our BEACON trial. The BEACON trial initially includes up to 45 patients ages 18 to 35 with severe sickle cell disease who have received prior treatment with at least one disease-modifying agent with inadequate response or intolerance. Following mobilization, conditioning and treatment with BEAM-101, patients are assessed for safety and tolerability, with safety endpoints including neutrophil and platelet engraftment. Patients are also assessed for efficacy, with efficacy endpoints including the change from baseline in severe vaso-occlusive events, transfusion requirements, HbF levels, and quality of life assessments. Thirty-five patients have cleared screening and enrolled in the BEACON trial. Of these patients, eight have been dosed with BEAM-101, with the other enrolled patients in pre-transplant stages, including cell collection and drug product manufacturing.
Previous wording
In parallel with Wave 1 development, we also aim to improve the transplant conditioning regimen for patients undergoing HSCT, thereby reducing toxicity challenges associated with HSCT. Conditioning is a critical component necessary to prepare a patient’s body to receive theex vivo edited cells that must engraft in the patient’s bone marrow in order to be effective. However, today’s conditioning regimens rely on nonspecific chemotherapy or radiation, which are associated with significant toxicities. As a potential alternative to genotoxic conditioning regimens in HSCT, we are advancing our ESCAPE program. ESCAPE aims to avoid toxicity challenges associated with currently available conditioning regimens for patients with sickle cell disease and beta-thalassemia ahead of autologous HSCT, by combining antibody-based conditioning with multiplex gene edited HSCs. ESCAPE may also have applications in other diseases of the blood and immune system where HSCT could deliver potential benefits but has been limited by toxicities associated with current standard of care conditioning regimens. We anticipate initiating Phase 1-enabling preclinical studies for the ESCAPE sickle cell disease program in 2024.
Current wording
In parallel with Wave 1 development, we also aim to improve the transplant conditioning regimen for patients undergoing HSCT, thereby reducing toxicity challenges associated with HSCT. Conditioning is a critical component necessary to prepare a patient’s body to receive theex vivo edited cells that must engraft in the patient’s bone marrow in order to be effective. However, today’s conditioning regimens rely on nonspecific chemotherapy or radiation, which are associated with significant toxicities. As a potential alternative to genotoxic conditioning regimens in HSCT, we are advancing our ESCAPE program. ESCAPE aims to avoid toxicity challenges associated with currently available conditioning regimens for patients with sickle cell disease and beta-thalassemia ahead of autologous HSCT, by combining antibody-based conditioning with multiplex gene edited HSCs. ESCAPE may also have applications in other diseases of the blood and immune system where HSCT could deliver potential benefits but has been limited by toxicities associated with current standard of care conditioning regimens.
Previous wording
We are conducting a Phase 1/2 open label, dose escalation study of BEAM-302 at trial sites located in the United Kingdom. The trial will evaluate the safety, pharmacodynamics, pharmacokinetics and efficacy of BEAM-302 initially in patients with AATD-associated lung disease. The study design includes a dose exploration portion followed by a dose expansion portion to identify the optimal dose to take forward in a pivotal study. In June 2024, we announced that the first patient had been dosed in the dose exploration portion of the trial. We anticipate continuing to enroll the Phase 1/2 clinical trial and expect to report initial clinical data in 2025.
Current wording
We are conducting a Phase 1/2 open label, dose escalation study of BEAM-302 at trial sites located in the United Kingdom. The trial will evaluate the safety, pharmacodynamics, pharmacokinetics and efficacy of BEAM-302 initially in patients with AATD-associated lung disease. The study design includes a dose exploration portion followed by a dose expansion portion to identify the optimal dose to take forward in a pivotal study. We have completed dosing of the first cohort of patients in the dose exploration portion of the trial. We continue to progress enrollment and global site activation and expect to report initial clinical data from multiple cohorts in the trial in 2025.
Previous wording
In October 2023, we presented new preclinical data demonstrating the ability of BEAM-301 to directly correct the R83C mutation. These data showed that a single dose of BEAM-301 restored clinically meaningful endpoints inin vivo rodent disease models out to at least one year. In July 2024, we received clearance from the U.S. Food and Drug Administration, or the FDA, for our IND for BEAM-301. We are initiating site activation activities for a Phase 1/2 clinical trial for BEAM-301 in patients with GSD1a with patient dosing expected to commence in early 2025.
Current wording
In October 2023, we presented new preclinical data demonstrating the ability of BEAM-301 to directly correct the R83C mutation. These data showed that a single dose of BEAM-301 restored clinically meaningful endpoints inin vivo rodent disease models out to at least one year. In July 2024, we received clearance from the U.S. Food and Drug Administration, or the FDA, for our IND for BEAM-301. We are continuing site activation activities for a Phase 1/2 clinical trial for BEAM-301 in patients with GSD1a with patient dosing expected to commence in early 2025.
Previous wording
BEAM-201 is a development candidate comprised of T cells derived from healthy donors that are simultaneously edited at TRAC, CD7, CD52 and PDCD1 and then transduced with a lentivirus encoding for an anti-CD7 chimeric antigen receptor, or CAR, that is designed to create allogeneic CD7 targeting CAR-T cells, resistant to both fratricide and immunosuppression. We have dosed multiple patients in a first-in-human Phase 1/2 clinical trial designed to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. Key safety endpoints for the trial include treatment-emergent and treatment-related adverse events, and key efficacy endpoints include proportion of patients with complete or partial responses, proportion eligible for HSC transplant and proportion achieving minimal residual disease negative status. We expect to report an initial clinical dataset for BEAM-201 in the fourth quarter of 2024.
Current wording
BEAM-201 is a development candidate comprised of T cells derived from healthy donors that are simultaneously edited at TRAC, CD7, CD52 and PDCD1 and then transduced with a lentivirus encoding for an anti-CD7 chimeric antigen receptor, or CAR, that is designed to create allogeneic CD7 targeting CAR-T cells, resistant to both fratricide and immunosuppression. We have dosed multiple patients in a first-in-human Phase 1/2 clinical trial designed to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. Key safety endpoints for the trial include treatment-emergent and treatment-related adverse events, and key efficacy endpoints include proportion of patients with complete or partial responses, proportion eligible for HSC transplant and proportion achieving minimal residual disease negative status.
Previous wording
In April 2019, we entered into a collaboration and license agreement, or the Verve Agreement, with Verve Therapeutics, Inc., or Verve, a company focused on gene editing for cardiovascular disease treatments, and in July 2022, we and Verve amended the Verve Agreement. Under the terms of the Verve Agreement, as amended, we granted Verve exclusive worldwide licenses under certain of our editing technologies for human therapeutic applications against a total of three liver-mediated, cardiovascular disease targets, including use of our base editing technology for each of these targets and use of certain of our gene editing technology for two of such targets. In exchange, we received shares of Verve common stock. In October 2023, we entered into a transfer and delegation agreement, or the Lilly Agreement, with Eli Lilly and Company, or Lilly, pursuant to which Lilly acquired certain assets and other rights under the Verve Agreement, including our opt-in rights to co-develop and co-commercialize each of Verve’s base editing programs for cardiovascular disease, which consist of programs targeting PCSK9, ANGPTL3 and an undisclosed liver-mediated, cardiovascular target. In addition, Lilly acquired the right to receive any future milestone or royalty payments payable to us under the Verve Agreement. Under the terms of the Lilly Agreement, we received a $200.0 million payment and are eligible to receive up to $350.0 million in potential future development-stage payments upon the completion of certain clinical, regulatory and alliance events. In October 2023, we also entered into a Stock Purchase Agreement, or the Purchase Agreement, with Lilly providing for the sale and issuance of 2,004,811 shares, of our common stock to Lilly at a price of $24.94 per share, which was equal to a 15% premium to the volume-weighted average share price of our common stock over the 30 trading days prior to the date of the Purchase Agreement, for an aggregate purchase price of approximately $50 million. The Purchase Agreement contains customary representations, warranties and covenants of each party.
Current wording
In April 2019, we entered into a collaboration and license agreement, or the Verve Agreement, with Verve Therapeutics, Inc., or Verve, a company focused on gene editing for cardiovascular disease treatments, and in July 2022, we and Verve amended the Verve Agreement. Under the terms of the Verve Agreement, as amended, we granted Verve exclusive worldwide licenses under certain of our editing technologies for human therapeutic applications against a total of three liver-mediated, cardiovascular disease targets, including use of our base editing technology for each of these targets and use of certain of our gene editing technology for two of such targets. In exchange, we received shares of Verve common stock. In October 2023, we entered into a transfer and delegation agreement, or the Lilly Agreement, with Eli Lilly and Company, or Lilly, pursuant to which Lilly acquired certain assets and other rights under the Verve Agreement, including our opt-in rights to co-develop and co-commercialize each of Verve’s base editing programs for cardiovascular disease, which consist of programs targeting PCSK9, ANGPTL3 and an undisclosed liver-mediated, cardiovascular target. In addition, Lilly acquired the right to receive any future milestone or royalty payments payable to us under the Verve Agreement. Under the terms of the Lilly Agreement, we received a $200.0 million payment and are eligible to receive up to $350.0 million in potential future development-stage payments upon the completion of certain clinical, regulatory and alliance events.
Previous wording
We are an early-stage company, and the majority of our programs are at a preclinical or early clinical stage of development. To date, we have not generated any revenue from product sales and do not expect to generate revenue from the sale of products for the foreseeable future. Our revenue to date has been primarily derived from license and collaboration agreements with partners. Since inception we have incurred significant operating losses. Our net losses for the six months ended June 30, 2024 and 2023 were $189.7 million and $179.2 million, respectively. As of June 30, 2024, we had an accumulated deficit of $1.4 billion. We expect to continue to incur significant expenses and increasing operating losses in connection with ongoing development activities related to our internal programs and collaborations as we continue our preclinical and clinical development of product candidates; advance additional product candidates toward clinical development; operate our cGMP facility in North Carolina; further develop our base editing platform; continue to make investments in delivery technology for our base editors; conduct research activities as we seek to discover and develop additional product candidates; maintain, expand, enforce, defend and protect our intellectual property portfolio; and continue to hire research and development, clinical, technical operations and commercial personnel. In addition, we expect to continue to incur the costs associated with operating as a public company.
Current wording
We are an early-stage company, and the majority of our programs are at a preclinical or clinical stage of development. To date, we have not generated any revenue from product sales and do not expect to generate revenue from the sale of products for the foreseeable future. Our revenue to date has been primarily derived from license and collaboration agreements with partners. Since inception we have incurred significant operating losses. Our net losses for the nine months ended September 30, 2024 and 2023 were $286.4 million and $275.3 million, respectively. As of September 30, 2024, we had an accumulated deficit of $1.5 billion. We expect to continue to incur significant expenses and increasing operating losses in connection with ongoing development activities related to our internal programs and collaborations as we continue our preclinical and clinical development of product candidates; advance additional product candidates toward clinical development; operate our cGMP facility in North Carolina; further develop our base editing platform; continue to make investments in delivery technology for our base editors; conduct research activities as we seek to discover and develop additional product candidates; maintain, expand, enforce, defend and protect our intellectual property portfolio; and continue to hire research and development, clinical, technical operations and commercial personnel. In addition, we expect to continue to incur the costs associated with operating as a public company.
Previous wording
We have not generated any revenue to date from product sales and do not expect to do so in the near future. During the six months ended June 30, 2024 and 2023, we recognized $19.2 million and $44.3 million of license and collaboration revenue, respectively.
Current wording
We have not generated any revenue to date from product sales and do not expect to do so in the near future. During the nine months ended September 30, 2024 and 2023, we recognized $33.5 million and $61.5 million of license and collaboration revenue, respectively.
Previous wording
License and collaboration revenue was $11.8 million and $20.1 million for the three months ended June 30, 2024 and 2023, respectively. The decline in revenue of $8.3 million is due to the lower level of research activities on our license and collaboration programs. License and collaboration revenue represents revenue recorded under each of the Pfizer, Apellis, Verve, and Orbital Agreements.
Current wording
License and collaboration revenue was $14.3 million and $17.2 million for the three months ended September 30, 2024 and 2023, respectively. The decrease in revenue of $2.9 million is due to the lower level of research activities on our license and collaboration programs. License and collaboration revenue represents revenue recorded under each of the Pfizer, Apellis, Verve, and Orbital Agreements.
Previous wording
Research and development expenses were $87.0 million and $97.6 million for the three months ended June 30, 2024 and 2023, respectively. The following table summarizes our research and development expenses for the three months ended June 30, 2024 and 2023 (in thousands):
Current wording
Research and development expenses were $94.3 million and $100.1 million for the three months ended September 30, 2024 and 2023, respectively. The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands):
Previous wording
A decrease of $12.7 million in external research and development expenses driven by a $8.6 million decrease in outsourced services, driven primarily by the strategic reprioritization of pipeline programs, timing of manufacturing spend and fewer IND-enabling activities, partially offset by increased clinical activities for BEAM-101 and BEAM-302. Also contributing to the decrease in external research and development expenses is a decrease of $4.1 million in lab supply expenses primarily driven by a decrease in research and development activities as well as a shift of programs from research into development;
Current wording
A decrease of $7.0 million in external research and development expenses driven by a $6.2 million decrease in outsourced services, primarily due to the strategic reprioritization of pipeline programs, timing of manufacturing spend and fewer IND-enabling activities, partially offset by increased clinical activities for BEAM-101, BEAM-302 and BEAM-301. A decline in lab supply expenses of $0.8 million due to less research and development activities when compared to the prior year also contributed to the decline in external research and development expenses;
Previous wording
A decrease of $4.5 million of employee related costs due to the decline in research and development employees from 444 as of June 30, 2023, to 364 as of June 30, 2024;
Current wording
A decrease of $2.3 million of employee related costs due to the decline in research and development employees from 439 as of September 30, 2023, to 374 as of September 30, 2024;
Previous wording
An increase of $3.3 million in stock-based compensation from additional equity awards granted to existing employees;
Current wording
An increase of $3.1 million in stock-based compensation from additional equity awards granted to existing employees;
Previous wording
An increase of $1.9 million of facility and IT allocated costs, including depreciation, due to the expense allocated to research and development related to our leased facilities; and
Current wording
An increase of $1.6 million of facility and IT allocated costs, including depreciation, due to the expense allocated to research and development related to our leased facilities; and
Previous wording
General and administrative expenses were $29.6 million and $24.7 million for the three months ended June 30, 2024 and 2023, respectively. The increase of $5.0 million was primarily due to the following:
Current wording
General and administrative expenses were $26.5 million and $25.4 million for the three months ended September 30, 2024 and 2023, respectively. The increase of $1.1 million was primarily due to the following:
Previous wording
An increase of $1.6 million in employee related costs due to the increase in general and administrative employees from 88 as of June 30, 2023 to 97 as of June 30, 2024; and
Current wording
An increase of $1.7 million in employee related costs due to the growth in general and administrative employees from 86 as of September 30, 2023 to 98 as of September 30, 2024;
Previous wording
During the three months ended June 30, 2024 and 2023, we recorded $5.5 million of other income and $0.9 million of other expense, respectively, related to the change in fair value of success payment liabilities due to changes in the price of our common stock over the related periods. A portion of the success payment obligations were paid in June 2021; the remaining success payment obligations are still outstanding as of June 30, 2024 and will continue to be revalued at each reporting period.
Current wording
During the three months ended September 30, 2024 and 2023, we recorded $0.2 million of other expense and $4.7 million of other income, respectively, related to the change in fair value of success payment liabilities due to changes in the price of our common stock over the related periods. A portion of the success payment obligations were paid in June 2021; the remaining success payment obligations are still outstanding as of September 30, 2024 and will continue to be revalued at each reporting period.
Previous wording
During the six months ended June 30, 2024 and 2023, we recorded $10.9 million and $6.6 million of other expense, respectively, as a result of changes in the fair value of our investment in Verve and Prime common stock.
Current wording
During the three months ended September 30, 2024 and 2023, we recorded $2.1 million and $11.2 million of other expense, respectively, as a result of changes in the fair value of our investment in Verve and Prime common stock.
Previous wording
During the three months ended June 30, 2024 and 2023, we recorded $1.8 million and $2.2 million of other income, respectively, related to the change in fair value of the Guide technology and product contingent consideration liabilities.
Current wording
During the three months ended September 30, 2024 and 2023, we recorded less than $0.1 million of other expense and $6.0 million of other income, respectively, related to the change in fair value of the Guide technology and product contingent consideration liabilities.
Previous wording
Interest and other income (expense), net was $14.2 million and $12.0 million of net income for the three months ended June 30, 2024 and 2023, respectively. The change was primarily due to increases in interest income driven by increased market rates.
Current wording
Interest and other income (expense), net was $12.1 million and $12.7 million of net income for the three months ended September 30, 2024 and 2023, respectively. The change was primarily due to increases in interest income driven by increased market rates.
Previous wording
License and collaboration revenue was $19.2 million and $44.3 million for the six months ended June 30, 2024 and 2023, respectively. License and collaboration revenue represents revenue recorded under each of the Pfizer, Apellis, Verve, and Orbital Agreements and the change reflects the lower level of research activities performed in the six months ended June 30, 2024 as compared to June 30, 2023.
Current wording
License and collaboration revenue was $33.5 million and $61.5 million for the nine months ended September 30, 2024 and 2023, respectively. License and collaboration revenue represents revenue recorded under each of the Pfizer, Apellis, Verve, and Orbital Agreements and the change reflects the lower level of research activities performed in the nine months ended September 30, 2024 as compared to September 30, 2023.
Previous wording
Research and development expenses were $171.9 million and $197.3 million for the six months ended June 30, 2024 and 2023, respectively. The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
Research and development expenses were $266.1 million and $297.3 million for the nine months ended September 30, 2024 and 2023, respectively. The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
A decrease of $28.9 million in external research and development expenses driven by a $19.3 million decrease in outsourced services driven primarily by the strategic reprioritization of pipeline programs, timing of manufacturing spend and fewer IND-enabling activities, partially offset by increased clinical activities for BEAM-101 and BEAM-302. Also contributing to the decrease in expenses is a decline of $9.6 million in lab supply expenses, primarily due to a decrease in research and development activities as well as a shift of programs from research into development;
Current wording
A decrease of $35.8 million in external research and development expenses driven by a $25.5 million decrease in outsourced services driven primarily by the strategic reprioritization of pipeline programs, timing of manufacturing spend and fewer IND-enabling activities, partially offset by increased clinical activities for BEAM-101, BEAM-302 and BEAM-301. Also contributing to the decrease in expenses is a decline of $10.3 million in lab supply expenses, primarily due to a decrease in research and development activities as well as a shift of programs from research into development;
Previous wording
A decrease of $7.3 million of employee related expenses due to a reduction in the number of research and development employees from 444 as of June 30, 2023 to 364 as of June 30, 2024;
Current wording
A decrease of $9.7 million of employee related expenses due to a reduction in the number of research and development employees from 439 as of September 30, 2023 to 374 as of September 30, 2024;
Previous wording
An increase of $2.9 million of facility and IT allocated costs, including depreciation, due to the expense allocated to research and development related to our leased facilities; and
Current wording
An increase of $4.5 million of facility and IT allocated costs, including depreciation, due to the expense allocated to research and development related to our leased facilities.
Previous wording
General and administrative expenses were $56.4 million and $48.1 million for the six months ended June 30, 2024 and 2023, respectively. The increase of $8.2 million was primarily due to the following:
Current wording
General and administrative expenses were $82.9 million and $73.6 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $9.3 million was primarily due to the following:
Previous wording
An increase of $1.8 million in personnel related expenses and $0.9 million of facility and IT related costs, including depreciation. These increases were due to fees associated with outside consultants and an increase in the number of general and administrative employees from 88 as of June 30, 2023 to 97 as of June 30, 2024, and their related activities, as well as the expense allocated to general and administrative expenses related to our leased facilities; and
Current wording
An increase of $3.5 million in personnel related expenses due to an increase in fees associated with outside consultants and an increase in the number of general and administrative employees from 86 as of September 30, 2023 to 98 as of September 30, 2024, and their related activities;
Previous wording
An increase of $1.2 million in legal costs.
Current wording
An increase of $1.5 million in legal costs; and
Previous wording
During the six months ended June 30, 2024 and 2023, we recorded $2.6 million and $4.7 million of other income, respectively, related to the change in fair value of success payment liabilities due to a decrease in the price of our common stock over the related periods. A portion of the success payment obligations were paid in June 2021; the remaining success payment obligations are still outstanding as of June 30, 2024 and will continue to be revalued at each reporting period.
Current wording
During the nine months ended September 30, 2024 and 2023, we recorded $2.4 million and $9.4 million of other income, respectively, related to the change in fair value of success payment liabilities due to a decrease in the price of our common stock over the related periods. A portion of the success payment obligations were paid in June 2021; the remaining success payment obligations are still outstanding as of September 30, 2024 and will continue to be revalued at each reporting period.
Previous wording
During the three months ended June 30, 2024 and 2023, we recorded $7.6 million of other expense and $6.1 million of other income, respectively, as a result of changes in the fair value of our investment in Verve and Prime common stock.
Current wording
During the nine months ended September 30, 2024 and 2023, we recorded $13.0 million and $17.9 million of other expense, respectively, as a result of changes in the fair value of our investment in Verve and Prime common stock.
Previous wording
During the six months ended June 30, 2024 and 2023, we recorded $1.6 million and $1.9 million of other income, respectively, related to the change in fair value of the Guide technology and product contingent consideration liabilities.
Current wording
During the nine months ended September 30, 2024 and 2023, we recorded $1.6 million and $7.9 million of other income, respectively, related to the change in fair value of the Guide technology and product contingent consideration liabilities.
Previous wording
Interest and other income (expense), net was $26.0 million and $21.9 million of net income for the six months ended June 30, 2024 and 2023, respectively. The change was primarily due to increases in interest income driven by increased market rates.
Current wording
Interest and other income (expense), net was $38.2 million and $34.6 million of net income for the nine months ended September 30, 2024 and 2023, respectively. The change was primarily due to increases in interest income driven by increased market rates.
Previous wording
In October 2023, we entered into the Lilly Agreement, pursuant to which Lilly acquired certain assets and other rights under the Verve Agreement, including our opt-in rights to co-develop and co-commercialize Verve’s base editing programs for cardiovascular disease. We received a $200.0 million upfront payment and are eligible to receive up to $350.0 million in potential future development-stage payments upon the completion of certain clinical, regulatory and alliance events. In connection with the Lilly Agreement, we and Lilly entered into a Stock Purchase Agreement providing for the sale and issuance of 2,004,811 shares of our common stock to Lilly for an aggregate purchase price of $50.0 million. We received the consideration under the Stock Purchase Agreement in October 2023 and the upfront payment in November 2023. We have accrued approximately $21.6 million of contingent obligations that may be due associated with payments received under the Lilly Agreement for which discussions are continuing related to the potential applicability to such payments of the terms of license agreements.
Current wording
In October 2023, we entered into the Lilly Agreement, pursuant to which Lilly acquired certain assets and other rights under the Verve Agreement, including our opt-in rights to co-develop and co-commercialize Verve’s base editing programs for cardiovascular disease. We received a $200.0 million upfront payment and are eligible to receive up to $350.0 million in potential future development-stage payments upon the completion of certain clinical, regulatory and alliance events. In connection with the Lilly Agreement, we and Lilly entered into a Stock Purchase Agreement providing for the sale and issuance of 2,004,811 shares of our common stock to Lilly for an aggregate purchase price of $50.0 million. We received the consideration under the Stock Purchase Agreement in October 2023 and the upfront payment in November 2023. We have accrued approximately $20.7 million of contingent obligations that may be due associated with payments received under the Lilly Agreement for which discussions are continuing related to the potential applicability to such payments of the terms of license agreements.
Previous wording
As of June 30, 2024, we had $1.0 billion in cash, cash equivalents, and marketable securities.
Current wording
As of September 30, 2024, we had $925.8 million in cash, cash equivalents, and marketable securities.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was $182.8 million, including our net loss of $189.7 million, decreases in accrued expenses and other liabilities of $43.8 million, deferred revenue of $18.2 million, and operating lease liabilities totaling $6.2 million and an increase of prepaid expenses and other current assets of $0.7 million. In addition, noncash items, including the amortization of investment premiums of $12.5 million, a decrease in the fair value of derivative liabilities of $2.6 million and a decrease of $1.6 million in the fair value of our contingent consideration liabilities also contributed to net cash used in operating activities.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $270.9 million, including our net loss of $286.4 million, decreases in accrued expenses and other liabilities of $53.6 million, deferred revenue of $31.5 million, and operating lease liabilities totaling $9.7 million and an increase of prepaid expenses and other current assets of $2.5 million. In addition, noncash items, including the amortization of investment premiums of $18.1 million, a decrease in the fair value of derivative liabilities of $2.4 million and a decrease of $1.6 million in the fair value of our contingent consideration liabilities also contributed to net cash used in operating activities.
Previous wording
These uses of cash were partially offset by an increase in accounts payable of $3.1 million and other long-term liabilities of $0.5 million, respectively. In addition, we recorded noncash items consisting of stock-based compensation expense of $60.9 million, depreciation and amortization expense of $11.0 million, a decrease in the fair value of non-controlling equity investments of $10.9 million and a decrease in operating lease right-of-use, or ROU, assets of $4.8 million.
Current wording
These uses of cash were partially offset by an increase in accounts payable of $2.4 million and other long-term liabilities of $0.5 million, respectively. In addition, we recorded noncash items consisting of stock-based compensation expense of $90.4 million, depreciation and amortization expense of $16.5 million, a decrease in the fair value of non-controlling equity investments of $13.0 million and a decrease in operating lease right-of-use, or ROU, assets of $7.2 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2023 was $194.5 million, consisting of our net loss of $179.2 million, a decrease in deferred revenue of $42.8 million, decreases in accrued expenses and other liabilities of $10.2 million, increases in prepaid expenses and other current assets of $6.5 million and a decrease in operating lease liabilities totaling $4.1 million. In addition, we recorded noncash items consisting of amortization of investment premiums of $14.5 million and decreases in the fair value of derivative liabilities and contingent consideration liabilities of $4.7 million and $1.9 million, respectively.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2023 was $284.3 million, consisting of our net loss of $275.3 million, a decrease in deferred revenue of $60.0 million, decreases in accounts payable of $5.8 million, accrued expenses and other liabilities of $2.7 million, increases in prepaid expenses and other current assets of $10.0 million, and a decrease in operating lease liabilities totaling $7.2 million. In addition, we recorded noncash items consisting of amortization of investment premiums of $22.4 million, and decreases in the fair value of derivative liabilities of $9.4 million and the fair value of contingent consideration liabilities of $7.9 million, respectively.
Previous wording
These uses of cash were partially offset by an increase in other long-term liabilities of $1.0 million and noncash items consisting of stock-based compensation expense of $50.2 million, decreases in the fair value of non-controlling equity investments of $6.6 million, depreciation and amortization expense of $9.5 million and changes in operating lease ROU assets of $4.8 million.
Current wording
These uses of cash were partially offset by noncash items consisting of stock-based compensation expense of $76.0 million, decreases in the fair value of non-controlling equity investments of $17.9 million, depreciation and amortization expense of $14.7 million and changes in operating lease right-of-use (ROU) assets of $7.1 million.
Previous wording
For the six months ended June 30, 2024, cash provided by investing activities consisted of net maturities of marketable securities of $38.4 million, partially offset by purchases of property and equipment of $4.4 million.
Current wording
For the nine months ended September 30, 2024, cash provided by investing activities consisted of net maturities of marketable securities of $64.7 million, partially offset by purchases of property and equipment of $6.0 million.
Showing the first 40 of 46 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In October 2023, we also entered into a Stock Purchase Agreement, or the Purchase Agreement, with Lilly providing for the sale and issuance of 2,004,811 shares, of our common stock to Lilly at a price of $24.94 per share, which was equal to a 15% premium to the volume-weighted average share price of our common stock over the 30 trading days prior to the date of the Purchase Agreement, for an aggregate purchase price of approximately $50 million. The Purchase Agreement contains customary representations, warranties and covenants of each party.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
An increase of $1.6 million in legal costs.