Sana Biotechnology Inc

Previous wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice. The key to making this vision a reality will be finding consistent and scalable means of manufacturing cell-based medicines, and we have invested significantly in our hypoimmune platform (HIP) technology with the twin goals of using allogeneic cells that evade immune detection in patients and that we can manufacture at scale. We are developing cell engineering programs to revolutionize treatment across a broad array of therapeutic areas with unmet treatment needs, including oncology, diabetes, B-cell-mediated autoimmune diseases, and central nervous system disorders, among others.

Current wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice. The key to making this vision a reality will be finding consistent and scalable means of manufacturing cell-based medicines, and we have invested significantly in our hypoimmune platform (HIP) technology with the twin goals of using allogeneic cells that evade immune detection in patients and that we can manufacture at scale. We are developing cell engineering programs to revolutionize treatment across therapeutic areas with unmet treatment needs, including type 1 diabetes, B-cell mediated autoimmune diseases, and oncology.

Previous wording

We currently have four ongoing clinical trials evaluating our product candidates, or product candidates developed using our technologies, across seven diseases in multiple therapeutic areas, including B-cell malignancies, B-cell-mediated autoimmune diseases, and type 1 diabetes, as described below:

Current wording

We are advancing three clinical programs evaluating our product candidates, or product candidates developed using our technologies, across five indications, including type 1 diabetes, B-cell mediated autoimmune diseases, and refractory B-cell malignancies, as described below:

Previous wording

The investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic primary islet cell therapy engineered with our HIP technology, in patients with type 1 diabetes mellitus.

Current wording

Type 1 Diabetes: The investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic primary islet cell therapy engineered with our HIP technology, in patients with type 1 diabetes mellitus;

Previous wording

GLEAM, our Phase 1 clinical trial evaluating SC291 in patients with lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis;

Current wording

B-cell Mediated Autoimmune Diseases: GLEAM, our Phase 1 clinical trial evaluating SC291, our HIP-modified CD19 allogeneic chimeric antigen receptor (CAR) T therapy, in patients with lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis; and

Previous wording

VIVID, our Phase 1 clinical trial evaluating SC262, our HIP-modified CD22 CAR T program, in patients with relapsed or refractory B-cell malignancies who have received prior CD19 CAR T therapy; and

Current wording

Oncology: VIVID, our Phase 1 clinical trial evaluating SC262, our HIP-modified CD22 allogeneic CAR T therapy, in patients with relapsed or refractory B-cell malignancies who have received prior CD19 CAR T therapy.

Previous wording

ARDENT, our Phase 1 clinical trial evaluating SC291, our HIP-modified CD19 targeted allogeneic chimeric antigen receptor (CAR) T program, in B-cell malignancies, including non-Hodgkin’s lymphoma and chronic lymphoblastic leukemia;

Current wording

In November 2024, we announced a strategic repositioning to prioritize clinical and preclinical development in type 1 diabetes, B-cell mediated autoimmune diseases, refractory B-cell malignancies, and the fusogen platform for generating in vivo CAR T cells. We will suspend development of SC291, our HIP-modified CD19 allogeneic CAR T therapy, in oncology and SC379, our glial progenitor cell program, as we seek partnerships for these programs. As part of these efforts, we will wind down the ARDENT Phase 1 clinical trial evaluating SC291 in B-cell malignancies, including non-Hodgkin’s lymphoma and chronic lymphoblastic leukemia.

Previous wording

We seek to overcome several existing limitations of gene and cell therapy through our ex vivo andin vivo cell engineering platforms, both of which may facilitate the development of therapies that can transform the lives of patients by repairing cells in the body when possible and replacing them when needed. Forex vivo therapies, when diseased cells are damaged or missing entirely and an effective therapy needs to replace the entire cell, a successful therapeutic requires large-scale manufacturing of cells that engraft, function, and persist in the body. Of these, we view cell persistence as the greatest current limitation to dramatically expanding the impact of this class of therapeutics, and in particular, overcoming the barrier of immune rejection of transplanted allogeneic cells. We believe that product candidates developed with ourex vivo cell engineering platform, which uses HIP-modified allogeneic cells that can “hide” from the patient’s immune system, can address this fundamental limitation and unlock a wave of disruptive therapeutics. We refer to this technology as our hypoimmune platform. Forin vivo therapies that aim to repair and control genes in the body, a successful product candidate requires both gene modification andin vivo delivery of the therapeutic payload. Of these, we view effectivein vivo delivery as the greatest current limitation to dramatically expanding the impact of this class of therapeutics. To this end, our initial focus is on cell-specific delivery of genetic payloads. Based upon early clinical as well as extensive preclinical data from our HIP platform, we decided in October 2023 to focus a meaningful portion of our research and development resources for at least the next several years on HIP-modifiedex vivo manufactured cells as therapeutics.

Current wording

We seek to overcome several existing limitations of gene and cell therapy through our ex vivo andin vivo cell engineering platforms, both of which may facilitate the development of therapies that can transform the lives of patients by repairing cells in the body when possible and replacing them when needed. Forex vivo therapies, when diseased cells are damaged or missing entirely and an effective therapy needs to replace the entire cell, a successful therapeutic requires large-scale manufacturing of cells that engraft, function, and persist in the body. Of these, we view cell persistence as the greatest current limitation to dramatically expanding the impact of this class of therapeutics, and in particular, overcoming the barrier of immune rejection of transplanted allogeneic cells. We believe that product candidates developed with ourex vivo cell engineering platform, which uses HIP-modified allogeneic cells that can “hide” from the patient’s immune system, can address this fundamental limitation and unlock a wave of disruptive therapeutics. We refer to this technology as our hypoimmune platform. Forin vivo therapies that aim to repair and control genes in the body, a successful product candidate requires both gene modification andin vivo delivery of the therapeutic payload. Of these, we view effectivein vivo delivery as the greatest current limitation to dramatically expanding the impact of this class of therapeutics. To this end, our initial focus is on cell-specific delivery of genetic payloads.

Previous wording

Each of our initial programs provides the potential for meaningful standalone value while also supporting our potential ability to further exploit our platforms in a manner that leads to the development of broadly applicable medicines. Based on our current timelines for our lead programs, we believe our cash runway will enable multiple data readouts across our programs.

Current wording

Each of our programs provides the potential for meaningful standalone value while also supporting our potential ability to further exploit our platforms in a manner that leads to the development of broadly applicable medicines. Based on our current timelines for our lead programs, we believe our cash runway will enable multiple data readouts across our programs. We expect to share clinical proof of concept data across multiple studies in 2024 or 2025.

Previous wording

Additionally, we continue to make progress on advancing our research- and preclinical-stage product candidates into and through preclinical development and toward potential IND submissions in 2025 and beyond. As certain of our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicity studies and establishing necessary scale-up for our manufacturing processes.

Current wording

Additionally, we continue to make progress on advancing our research- and preclinical-stage product candidates into and through preclinical development and toward potential IND submissions. As certain of our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicity studies and establishing necessary scale-up for our manufacturing processes.

Previous wording

Ourex vivo andin vivo technologies represent an aggregation of years of innovation and technology from multiple academic institutions and companies, including hypoimmune technology licensed from the President and Fellows of Harvard College (Harvard) and The Regents of the University of California, ourex vivo cell engineering program focused on certain brain disorders acquired from Oscine Corp., fusogen technology acquired from Cobalt Biomedicines Inc. (Cobalt), and gene editing technology licensed from Beam Therapeutics Inc., among others. For details regarding these acquisitions and license and collaboration agreements, see Note 3, Acquisitions and Note 4, License and collaboration agreements to our consolidated financial statements included in our 2023 Annual Report, as well as the section titled “Business— Key Intellectual Property Agreements” in Part I, Item 1 included in our 2023 Annual Report.

Current wording

Ourex vivo andin vivo technologies represent an aggregation of years of innovation and technology from multiple academic institutions and companies, including hypoimmune technology licensed from the President and Fellows of Harvard College (Harvard) and The Regents of the University of California, fusogen technology acquired from Cobalt Biomedicines Inc. (Cobalt), and gene editing technology licensed from Beam Therapeutics Inc., among others. For details regarding these acquisitions and license and collaboration agreements, see Note 3, Acquisitions and Note 4, License and collaboration agreements to our consolidated financial statements included in our 2023 Annual Report, as well as the section titled “Business— Key Intellectual Property Agreements” in Part I, Item 1 included in our 2023 Annual Report.

Previous wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. Since our inception, we have incurred net losses each year. Our net losses for the six months ended June 30, 2024 and 2023 were $157.8 million and $196.1 million, respectively. As of June 30, 2024, we had an accumulated deficit of $1.5 billion, which includes cumulative non-cash charges of $18.5 million and $60.4 million related to the revaluation of the success payment liabilities and contingent consideration, respectively. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Current wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. Since our inception, we have incurred net losses each year. Our net losses for the nine months ended September 30, 2024 and 2023 were $217.7 million and $195.1 million, respectively. As of September 30, 2024, we had an accumulated deficit of $1.6 billion, which includes cumulative non-cash charges of $12.7 million and $60.6 million related to the revaluation of the success payment liabilities and contingent consideration, respectively. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Previous wording

As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $251.6 million. Based on our current operating plan, we expect 2024 operating cash burn of less than $200.0 million and believe that our existing cash, cash equivalents, and marketable securities will be sufficient to meet our working capital and capital expenditure needs for at least 12 months from the filing of this Quarterly Report.

Current wording

As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $199.0 million. Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs for at least 12 months from the filing of this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors.

Previous wording

We expect our operating losses and expenses to decrease in 2024, excluding potential one-time items, as a result of our strategic repositioning in October 2023, and likely increase over the longer term from the 2024 level if our clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by advancing our current and future product candidates through clinical trials; identifying additional product candidates; establishing our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs) and building our internal manufacturing capabilities; advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with our ambition of translating engineered cells to medicines; seeking regulatory approval of our current and future product candidates; increasing our workforce to support our research, clinical and preclinical development, manufacturing, and commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

Current wording

We expect our operating losses and expenses to decrease in 2025 compared to 2024 as a result of our strategic repositioning in November 2024. Operating expenses may increase over the longer term if our clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates through clinical trials; identifying additional product candidates; establishing our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs) and building our internal manufacturing capabilities; advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with our ambition of translating engineered cells to medicines; seeking regulatory approval of our current and future product candidates; increasing our workforce to support our research, clinical and preclinical development, manufacturing, and commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

Previous wording

We anticipate that we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and upfront, milestone, and royalty payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Current wording

We will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and upfront, milestone, and royalty payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Previous wording

Our business and operations may be negatively affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as the timing of changes to inflation and interest rates, declines in consumer confidence, declines in economic growth, uncertainty in the markets, geo-political and economic stability resulting from the ongoing Russia-Ukraine war, conflict in the Middle East, tensions in U.S.-China relations, and the aftermath of the COVID-19 pandemic. The severity and duration of the impact of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events and conditions on our business, financial condition, and operating results, see the section titled “Risk Factors” included in this Quarterly Report.

Current wording

Our business and operations may be negatively affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as the timing of changes to inflation and interest rates, declines in consumer confidence, declines in economic growth, uncertainty in the markets, geo-political and economic stability resulting from the ongoing Russia-Ukraine war, escalation of conflict in the Middle East, tensions in U.S.-China relations, and the aftermath of the COVID-19 pandemic. The severity and duration of the impact of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events and conditions on our business, financial condition, and operating results, see the section titled “Risk Factors” included in this Quarterly Report.

Previous wording

Research and development activities account for a significant portion of our operating expenses. As a result of our strategic repositioning and associated workforce reduction in October 2023, we anticipate that our research and development expenses will decrease in 2024, excluding potential one-time items, and likely increase over the longer term from the 2024 level if our clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; establishing internal and external manufacturing capabilities; advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with our ambition of translating engineered cells to medicines; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research and development operations. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates.

Current wording

Research and development activities account for a significant portion of our operating expenses. As a result of our strategic repositioning and associated workforce reduction in November 2024, we expect our research and development expenses to decrease in 2025 compared to 2024. Research and development expenses may increase over the longer term if our clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; establishing internal and external manufacturing capabilities; advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with our ambition of translating engineered cells to medicines; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research and development operations. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates.

Previous wording

General and administrative expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation for our employees in finance, legal, executive, human resources, and information technology functions, legal and consulting fees, insurance fees, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate and patent matters.

Current wording

General and administrative expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation for our employees in finance, legal, executive, human resources, and information technology functions, legal and consulting fees, insurance fees, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate and patent matters. General and administrative expenses for the three and nine months ended September 30, 2023 include costs incurred for the early termination of our lease in Fremont, California (Fremont lease).

Previous wording

As a result of our strategic repositioning and associated workforce reduction in October 2023, we anticipate that our general and administrative expenses will decrease in 2024, excluding potential one-time items, and likely increase over the longer term from the 2024 level to support potential expanded research and development activities.

Current wording

As a result of our strategic repositioning and associated workforce reduction in November 2024, we expect our general and administrative expenses to decrease in 2025 compared to 2024. General and administrative expenses may increase over the longer term to support potential expanded research and development activities.

Previous wording

Comparison of the three and six months ended June 30, 2024 and 2023

Current wording

Comparison of the three and nine months ended September 30, 2024 and 2023

Previous wording

Research and development expense was $60.9 million and $73.0 million for the three months ended June 30, 2024 and 2023, respectively. The decrease of $12.1 million was primarily due to:

Current wording

Research and development expense was $53.2 million and $65.6 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of $12.4 million was primarily due to:

Previous wording

a decrease of $10.4 million in research expenses primarily due to lower research and development headcount;

Current wording

a decrease of $6.1 million in research and laboratory expenses primarily due to lower research and development headcount;

Previous wording

a net decrease of $6.4 million in personnel-related expenses due to lower research and development headcount related to the strategic repositioning in October 2023, partially offset by an increase in personnel-related costs for the acceleration of our internal manufacturing capabilities;

Current wording

a net decrease of $4.7 million in personnel-related expenses due to lower research and development headcount related to the strategic repositioning in October 2023, partially offset by an increase in personnel-related costs for the acceleration of our internal manufacturing capabilities;

Previous wording

a decrease of $2.7 million in third-party manufacturing costs for CDMOs; and

Current wording

a decrease of $3.6 million in third-party manufacturing costs for CDMOs; and

Previous wording

a net decrease of $0.5 million in facility and other allocated costs, partially offset by an increase in costs for the acceleration of our internal manufacturing capabilities.

Current wording

a net decrease of $1.4 million in facility and other allocated costs, partially offset by an increase in costs for the acceleration of our internal manufacturing capabilities.

Previous wording

These decreases were partially offset by an increase of $3.3 million in clinical development costs.

Current wording

These decreases were partially offset by an increase of $3.5 million in clinical development costs.

Previous wording

Research and development expense was $117.3 million and $140.2 million for the six months ended June 30, 2024 and 2023, respectively. The decrease of $22.9 million was primarily due to:

Current wording

Research and development expense was $170.5 million and $205.8 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $35.3 million was primarily due to:

Previous wording

a decrease of $6.5 million in research expenses primarily due to lower research and development headcount;

Current wording

a decrease of $16.4 million in research expenses primarily due to lower research and development headcount;

Previous wording

a net decrease of $10.8 million in personnel-related expenses due to lower research and development headcount related to the strategic repositioning in October 2023, partially offset by an increase in personnel-related costs for the acceleration of our internal manufacturing capabilities;

Current wording

a net decrease of $15.2 million in personnel-related expenses due to lower research and development headcount related to the strategic repositioning in October 2023, partially offset by an increase in personnel-related costs for the acceleration of our internal manufacturing capabilities;

Previous wording

a decrease of $4.7 million in third-party manufacturing costs for CDMOs; and

Current wording

decrease of $8.3 million in third-party manufacturing costs for CDMOs; and

Previous wording

a net decrease of $2.3 million in facility and other allocated costs, partially offset by an increase in costs for the acceleration of our internal manufacturing capabilities.

Current wording

a net decrease of $3.6 million in facility and other allocated costs, partially offset by an increase in costs for the acceleration of our internal manufacturing capabilities.

Previous wording

These decreases were partially offset by an increase of $5.5 million in clinical development costs.

Current wording

These decreases were partially offset by an increase of $8.9 million in clinical development costs.

Previous wording

The gain related to the change in the estimated fair value of our Cobalt Success Payment was $20.7 million for the three months ended June 30, 2024, compared to an expense of $18.5 million for the same period in 2023. The changes in value were due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was $3.9 million for the three months ended June 30, 2024, compared to an expense of $2.3 million for the same period in 2023. The changes in value were primarily due to changes in our common stock price during the relevant periods. The gain related to the change in the estimated fair value of our Cobalt Contingent Consideration was $3.4 million compared to an expense of $5.9 million for the three months ended June 30, 2024 and 2023, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Current wording

The gains related to the change in the estimated fair value of our Cobalt Success Payment was $4.9 million for the three months ended September 30, 2024, compared to $22.0 million for the same period in 2023. The changes in value were due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was $0.8 million for the three months ended September 30, 2024, compared to $2.0 million for the same period in 2023. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $0.2 million compared to a gain of $58.6 million for the three months ended September 30, 2024 and 2023, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods and the discount rates used in the calculations.

Previous wording

The following table summarizes the expenses associated with research and development related success payments and contingent consideration for the periods presented:

Current wording

The following table summarizes the expenses (gains) associated with research and development related success payments and contingent consideration for the periods presented:

Previous wording

The expenses related to the change in the estimated fair value of our Cobalt Success Payment was $7.2 million for the six months ended June 30, 2024, compared to $13.7 million for the same period in 2023. The changes in value were due to changes in our market capitalization during the relevant periods. The expenses related to the change in the estimated fair value of our Harvard Success Payments was $0.8 million for the six months ended June 30, 2024, compared to $1.7 million for the same period in 2023. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expenses related to the change in the estimated fair value of our Cobalt Contingent Consideration was $2.0 million and $11.4 million for the six months ended June 30, 2024 and 2023, respectively. The changes in value were due to changes in the timing and probability of the achievement of milestones during the relevant periods.

Current wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $2.3 million for the nine months ended September 30, 2024, compared to a gain of $8.3 million for the same period in 2023. The changes in value were due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was immaterial for the nine months ended September 30, 2024, compared to a gain of $0.3 million for the same period in 2023. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $2.3 million and a gain of $47.2 million for the nine months ended September 30, 2024 and 2023, respectively. The changes in value were due to changes in the timing and probability of the achievement of milestones during the relevant periods and the discount rates used in the calculations.

Previous wording

General and administrative expenses were $16.4 million and $32.7 million for the three and six months ended June 30, 2024, respectively, compared to $16.6 million and $33.3 million for the same periods in 2023.

Current wording

General and administrative expenses were $14.1 million and $46.8 million for the three and nine months ended September 30, 2024, respectively, compared to $19.2 million and $52.5 million for the same periods in 2023.

Previous wording

The decrease of $0.2 million for the three months ended June 30, 2024 was primarily due to a decrease in costs related our previously planned manufacturing facility in Fremont, California, lower personnel-related costs due to a decrease in headcount related to the strategic repositioning in October 2023, and a decrease in legal fees. These decreases were partially offset by an increase in non-cash stock-based compensation and consulting fees.

Current wording

The decrease of $5.1 million for the three months ended September 30, 2024 was primarily due to a decrease in costs related our previously planned manufacturing facility in Fremont, California, a decrease in legal and consulting fees, and lower personnel-related costs due to a decrease in headcount. These decreases were partially offset by an increase in non-cash stock-based compensation.

Previous wording

The decrease of $0.6 million for the six months ended June 30, 2024 was primarily due to a decrease in costs related to our previously planned manufacturing facility in Fremont, California and lower personnel-related costs due to a decrease in headcount related to the strategic repositioning in the fourth quarter of 2023. These decreases were partially offset by an increase in non-cash stock-based compensation, legal fees, and consulting costs.

Current wording

The decrease of $5.8 million for the nine months ended September 30, 2024 was primarily due to a decrease in costs related to our previously planned manufacturing facility in Fremont, California, lower personnel-related costs due to a decrease in headcount, and lower legal fees. These decreases were partially offset by an increase in non-cash stock-based compensation.

Previous wording

Interest income, net, was $3.2 million and $6.2 million for the three and six months ended June 30, 2024, respectively, compared to $2.4 million and $4.4 million for the same periods in 2023, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Current wording

Interest income, net, was $2.6 million and $8.8 million for the three and nine months ended September 30, 2024, respectively, compared to $2.9 million and $7.2 million for the same periods in 2023, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Previous wording

As of June 30, 2024, we had $251.6 million in cash, cash equivalents, and marketable securities. To date we have raised an aggregate of approximately $1.5 billion in net proceeds from sales of common stock and private placements of our convertible preferred stock.

Current wording

As of September 30, 2024, we had $199.0 million in cash, cash equivalents, and marketable securities. To date we have raised an aggregate of approximately $1.5 billion in net proceeds from sales of common stock and private placements of our convertible preferred stock.

Previous wording

We expect to incur additional losses for the foreseeable future as we conduct and expand our research and development efforts, including conducting clinical trials and preclinical studies, developing new product candidates, establishing internal and external manufacturing capabilities, and funding our operations generally.

Current wording

We expect to incur additional losses for the foreseeable future as we conduct our research and development efforts, including conducting clinical trials and preclinical studies, developing new product candidates, establishing internal and external manufacturing capabilities, and funding our operations generally. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.