What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-03 compared with 2023-08-02 · 111 added, 106 removed, 228 unchanged (49% of the section changed)

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In the second quarter of 2022, we dosed the first patient in our Phase 1/2 clinical trial of EDIT-301, which we refer to as our RUBY trial, for the treatment of severe SCD, and in December 2022, announced initial clinical data from the first two patients treated in the RUBY trial.

This clinical data supports human proof of concept by showing that EDIT-301

could safely increase expression of fetal hemoglobin to clinically meaningful levels and correct anemia in SCD patients.

After completing sequential dosing of the first two patients, we commenced parallel patient dosing in the first quarter of 2023 and remain on track to dose 20 total patients by the end of 2023.

We provided an update on the initial clinical data from the RUBY trial in June 2023 and expect to provide an additional clinical update by the end of 2023.

In April 2023, the U.S.

Food and Drug Administration (“FDA”) granted Orphan Drug Designation to EDIT-301 for the treatment of SCD.

This clinical data supports human proof of concept by showing that EDIT-301 could safely increase expression of fetal hemoglobin to clinically meaningful levels and correct anemia in SCD patients.

After completing sequential dosing of the first two patients, we commenced parallel patient dosing in the first quarter of 2023.

Through November 3, 2023, we have enrolled 27 patients in the RUBY trial.

We expect to dose the 20th patient in the trial in the January 2024 timeframe.

We provided an update on the initial clinical data from the RUBY trial in June 2023 and expect to provide additional clinical updates in December 2023 and in the middle of 2024.

In October 2023, the U.S.

Food and Drug Administration (“FDA”) granted Regenerative Medicine Advanced Therapy designation to EDIT-301 for the treatment of SCD.

A product is eligible for this designation if it is a regenerative medicine therapy that is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product candidate has the potential to address unmet medical needs for such disease or condition.

The benefits of the designation include early interactions with the FDA to expedite development and review, benefits available to breakthrough therapies, potential eligibility for priority review and accelerated approval based on surrogate or intermediate endpoints.

In December 2021, the FDA cleared our Investigational New Drug (“IND”) application for a Phase 1/2 clinical trial of EDIT-301 for the treatment of TDT.

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We dosed the first patient in this trial in the first quarter of 2023 and commenced parallel patient dosing in the second quarter of 2023.

We provided an initial clinical data update on the first patient in the EDITHAL trial in June 2023 and remain on track to provide an additional update by the end of 2023.

Through November 3, 2023, we have enrolled eight patients in the EdiTHAL trial.

We provided an initial clinical data update on the first patient in the EdiTHAL trial in June 2023 and expect to provide an additional clinical update in December 2023.

In June 2023, we announced initial safety and efficacy data from the first four patients with SCD treated with EDIT-301 in the RUBY trial and from the first TDT patient treated in the EdiTHAL trial.

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Patient 1’s total hemoglobin returned to a normal physiological level of 16.4g/dL (male normal range:

13.6–18.0 g/dL) at five months after infusion of EDIT-301 and has been maintained at this level at the 10-month follow-up.

13.6–18.0 g/dL) at five months after infusion of EDIT-301 and was maintained at this level at the 10-month follow-up.

In addition, Patient 1’s fetal hemoglobin fraction increased from 5% at baseline to 45.4% five months after treatment with EDIT-301 and 43.4% at the 10-month follow-up.

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After EDIT-301 infusion, no serious adverse events occurred, and no adverse events reported were related to treatment with EDIT-301.

We are also pursuing the development of next generation in vivo administered gene editing medicines, in which the medicine is injected or infused into the patient to edit the cells inside their body.

We are also pursuing the development of next generation in vivo administered gene editing medicines, in which the medicine is injected or infused into the patient to edit the cells inside the body.

We are initially focused on editing HSCs through targeted delivery of our AsCas12a enzyme to our clinically validated HBG1 and HBG2 promotor site.

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to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer.

gene editing, seeking to identify potential product candidates, and undertaking preclinical studies.

In August 2023, we entered into a license agreement with Vor Biopharma Inc.

(“Vor Bio”), providing Vor Bio a non-exclusive license for the development of ex vivo Cas9 gene edited HSC therapies for the treatment and/or prevention of hematological malignancies.

Under this agreement, we received an upfront payment and will be eligible for future development, regulatory and commercial milestone payments, as well as royalties on medicines utilizing the related intellectual property.

Since our inception in September 2013, our operations have focused on organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio, assembling our core capabilities in gene editing, seeking to identify potential product candidates, and undertaking preclinical studies.

Except for EDIT-301, all of our ongoing research programs are still in the preclinical or research stage of development and the risk of failure of all of our research programs is high.

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Since inception, we have incurred significant operating losses.

Our net losses were $89.3 million and $104.0 million for the six months ended June 30, 2023 and 2022, respectively.

As of June 30, 2023, we had an accumulated deficit of $1.2 billion.

Our net losses were $134.3 million and $159.7 million for the nine months ended September 30, 2023 and 2022, respectively.

As of September 30, 2023, we had an accumulated deficit of $1.2 billion.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

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We no longer receive research funding support from BMS.

As of June 30, 2023, we recorded $56.7 million of deferred revenue in relation to our collaboration with BMS, all of which is classified as long-term on our condensed consolidated balance sheet.

As of September 30, 2023, we recorded $56.7 million of deferred revenue in relation to our collaboration with BMS, all of which is classified as long-term on our condensed consolidated balance sheet.

Under this collaboration, we will recognize revenue upon delivery of option packages to BMS or upon receipt of development milestone payments.

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Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates—Revenue Recognition” included in the Annual Report.

For the foreseeable future we expect substantially all of our revenue will be generated from our collaboration with BMS, and other collaborations or agreements we enter into.

For the foreseeable future we expect substantially all of our revenue will be generated from our collaboration with BMS, and other collaborations or license agreements we enter into.

Research and Development Expenses

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Other Income, Net

For the six months ended June 30, 2023 and 2022, other income, net consisted primarily of interest income, partially offset by accretion of discounts associated with other marketable securities.

For the nine months ended September 30, 2023 and 2022, other income, net consisted primarily of interest income, partially offset by accretion of discounts associated with other marketable securities.

Critical Accounting Policies and Estimates

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Results of Operations

Comparison of the Three Months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Comparison of the Three Months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

Dollar Change

Percentage Change

Collaboration and other research and development revenues

September 30, Dollar Change Percentage Change

Collaboration and other research and development revenues $ 5,336 $ 42 $ 5,294 n/m

Operating expenses:

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Other income, net

Other (expense) income, net

Interest income, net

Total other income, net

Other income, net — 1 (1) (100) %

Interest income, net 5,144 1,793 3,351 n/m

Total other income, net 5,144 1,794 3,350 n/m

Net loss $ (45,019) $ (55,726) $ 10,707 (19) %

For our results of operations, we have included the respective percentage of changes, unless greater than 100% or less than (100)%, in which case we have denoted such changes as not meaningful (n/m).

Collaboration and other research and development revenues

Collaboration and other research and development revenues decreased by $3.5 million, to $2.9 million for the three months ended June 30, 2023, compared to $6.4 million for three months ended June 30, 2022.

The decrease is primarily attributable to the exercise of a program opt-in under our collaboration with BMS in the second quarter of 2022 for which there was no similar activity in the second quarter of 2023.

Collaboration and other research and development revenues were $5.3 million for the three months ended September 30, 2023 compared to $42.0 thousand for the same period in 2022.

The increase from the three months ended September 30, 2022 is primarily attributable to an upfront payment for the non-exclusive license to Vor Bio in the third quarter of 2023.

Research and development expenses

Research and development expenses decreased by $13.9 million, to $29.8 million for the three months ended June 30, 2023 compared to $43.7 million for the same period in 2022.

The following table summarizes our research and development expenses for the three months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Research and development expenses decreased by $0.8 million to $40.5 million for the three months ended September 30, 2023 compared to $41.3 million for the same period in 2022.

The following table summarizes our research and development expenses for the three months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

Dollar Change

Percentage Change

September 30, Dollar Change Percentage Change

Employee related expenses $ 11,198 $ 11,768 $ (570) (5) %

External research and development expenses

External research and development 17,593 17,449 144 1 %

Facility expenses 5,073 5,414 (341) (6) %

Stock-based compensation expense 2,571 3,045 (474) (16) %

Sublicense and license fees 2,388 1,038 1,350 n/m

Other expenses 1,689 2,612 (923) (35) %

Stock-based compensation expenses

Sublicense and license fees

Total research and development expenses $ 40,512 $ 41,326 $ (814) (2) %

The decrease in research and development expenses for the three months ended June 30, 2023 compared to the three months ended June 30, 2022 was primarily attributable to:

● approximately $12.8 million in decreased external research and development expenses related to our reprioritization and targeted focus on our EDIT-301 program;

● approximately $1.5 million in decreased sublicense and license fees due to clinical milestone and sublicense fee payments under certain of our license agreements that occurred in the three months ended June 30, 2022 that did not occur for the same period in 2023;

● approximately $1.4 million in decreased employee-related expenses due to decreased headcount costs resulting from our reprioritization and related reduction in workforce in the first quarter of 2023;

The decrease in research and development expenses for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was primarily attributable to:

• approximately $0.9 million in decreased other expenses related to cost savings with external manufacturing support services;

• approximately $0.6 million in decreased employee-related expenses related to reduced headcount as a result of our strategic reprioritization;

• approximately $0.5 million in decreased stock-based compensation expenses;

• approximately $0.3 million in decreased facility expenses.

These decreases were partially offset by:

● approximately $1.7 million in increased other expenses related to increased consulting expenses;

● approximately $0.7 million in increased facility expenses primarily related to increased rent expense incurred in connection with a lease extension for office, manufacturing and lab space.

• approximately $1.4 million in increased sublicense and license fees paid in connection with licensing activity;

• approximately $0.1 million increase in external research and development expenses.

General and administrative expenses

General and administrative expenses increased by $0.3 million to $17.2 million for the three months ended June 30, 2023 compared to $16.9 million for the three months ended June 30, 2022.

The following table summarizes our general and administrative expenses for the three months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

General and administrative expenses decreased by $1.2 million to $15.0 million for the three months ended September 30, 2023 compared to $16.2 million for the three months ended September 30, 2022.

The following table

summarizes our general and administrative expenses for the three months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

Dollar Change

Percentage Change

September 30, Dollar Change Percentage Change

Employee related expenses $ 3,910 $ 4,709 $ (799) (17) %

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Total general and administrative expenses $ 14,987 $ 16,236 $ (1,249) (8) %

The increase in general and administrative expenses for the three months ended June 30, 2023 compared to the three months ended June 30, 2022 was primarily attributable to:

● approximately $1.9 million in increased professional service expenses to support strategic business development activities;

● approximately $0.4 million in increased employee related expenses for executive recruitment fees.

These increases were partially offset by:

● approximately $0.9 million in decreased stock-based compensation expenses;

The decrease in general and administrative expenses for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was primarily attributable to:

• approximately $0.9 million in decreased intellectual property and patent related fees due to reduced legal activity;

• approximately $0.8 million in decreased employee related expenses related to reduced headcount as a result of our strategic reprioritization;

• approximately $0.7 million in decreased stock-based compensation expenses due to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted;

• approximately $0.1 million in decreased facility and other expenses.

● approximately $0.6 million in decreased intellectual property and patent related fees.

These decreases were partially offset by approximately $1.2 million in increased professional service expenses to support strategic initiatives and business development activities.

Other income, net

For the three months ended June 30, 2023, other income, net was $3.8 million, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

For the three months ended June 30, 2022, other income, net was $0.8 million, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

Comparison of the Six Months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

For the three months ended September 30, 2023 and September 30, 2022 other income, net was $5.1 million and $1.8 million, respectively, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

The increase for three months ended September 30, 2023 was attributable to increased invested balances as well as favorable market rates.

Comparison of the Nine Months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Nine Months Ended

September 30, Dollar Change Percentage Change

Collaboration and other research and development revenues $ 18,074 $ 13,176 $ 4,898 37 %

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Other income, net

Other (expense) income, net

Interest income, net

Total other income, net

Other (expense) income, net (1,590) 4 (1,594) n/m

Interest income, net 12,464 2,806 9,658 n/m

Total other income, net 10,874 2,810 8,064 n/m

Net loss $ (134,345) $ (159,694) $ 25,349 (16) %

Collaboration and other research and development revenues

Collaboration and other research and development revenues slightly decreased by $0.4 million, to $12.7 million, for the six months ended June 30, 2023 from $13.1 million for six months ended June 30, 2022.

Collaboration and other research and development revenues increased by $4.9 million to $18.1 million for the nine months ended September 30, 2023 compared to $13.2 million for nine months ended September 30, 2022.

The increase was primarily related to the sale of our wholly owned oncology assets and licenses in January 2023, as well as an upfront payment for a non-exclusive license to Vor Bio in the third quarter of 2023, partially offset by the exercises of a program opt-in under our collaboration with BMS in 2022 for which there was no similar activity in 2023.

Research and development expenses

Research and development expenses decreased by $14.0 million, to $67.6 million, for the six months ended June 30, 2023 from $81.6 million for the six months ended June 30, 2022.

The following table summarizes our research and development expenses for the six months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

Research and development expenses decreased by $14.9 million to $108.1 million for the nine months ended September 30, 2023 compared to $123.0 million for the nine months ended September 30, 2022.

The following table summarizes our research and development expenses for the nine months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Nine Months Ended

September 30, Dollar Change Percentage Change

Employee related expenses $ 34,970 $ 35,502 $ (532) (1) %

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Facility expenses 16,053 14,476 1,577 11 %

Other expenses

Stock-based compensation expenses 7,182 9,803 (2,621) (27) %

Sublicense and license fees 4,700 4,526 174 4 %

Other expenses 8,080 6,580 1,500 23 %

Total research and development expenses $ 108,095 $ 122,960 $ (14,865) (12) %

The decrease in research and development expenses for the six months ended June 30, 2023 compared to the six months ended June 30, 2022 was primarily attributable to:

The decrease in research and development expenses for the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022 was primarily attributable to:

• approximately $15.0 million in decreased external research and development expenses related to our reprioritization and targeted focus on our EDIT-301 program;

● approximately $2.1 million in decreased stock-based compensation expense due primarily to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted in the six months ended June 30, 2023 ;

● approximately $1.2 million in decreased sublicense and license fees due to clinical milestone and sublicense fee payments under certain of our license agreements that occurred in the six months ended June 30, 2022 that did not occur for the same period in 2023.

• approximately $2.6 million in decreased stock-based compensation expense due primarily to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted ;

• approximately $0.5 million in decreased employee related expenses.

These decreases were partially offset by:

● approxi mately $ 2.4 million in increased other expenses attributable to consulting and external fees ;

• approximately $1.6 million in increased facility expenses primarily related to increased rent expense incurred in connection with a lease extension for office, manufacturing and lab space;

• approximately $1.5 million in increased other expenses attributable to consulting and external fees to support patient advocacy and medical affairs initiatives;

• approximately $0.2 million in increased sublicense and license fees.

General and administrative expenses

General and administrative expenses increased by $3.7 million, to $40.2 million, for the six months ended June 30, 2023 from $36.5 million for the six months ended June 30, 2022.

The following table summarizes our general and administrative expenses for the six months ended June 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

Professional service expenses

General and administrative expenses increased by $2.5 million to $55.2 million for the nine months ended September 30, 2023 compared to $52.7 million for the nine months ended September 30, 2022.

The following table summarizes our general and administrative expenses for the nine months ended September 30, 2023 and 2022, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Nine Months Ended

September 30, Dollar Change Percentage Change

Employee related expenses $ 12,663 $ 13,067 $ (404) (3) %

Professional service expenses 17,190 7,075 10,115 n/m

Intellectual property and patent related fees 10,687 10,535 152 1 %

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Total general and administrative expenses $ 55,198 $ 52,720 $ 2,478 5 %

The increase in general and administrative expenses for the six months ended June 30, 2023 compared to the six months ended June 30, 2022 was primarily attributable to:

● approxi mately $8.9 million in increased professional service expenses to support strategic business development activities ;

● approximately $ 1.0 million in in creased intellectual property and patent related fees primarily resulting from in creased legal fees related to the prosecution and maintenance of our patents;

● approximately $0.

4 million in in creased employee related expenses for executive recruitment fees .

The increase in general and administrative expenses for the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022 was primarily attributable to:

• approximately $10.1 million in increased professional service expenses to support strategic initiatives and business development activities;

• approximately $0.2 million in increased intellectual property and patent related fees.

These increases were partially offset by:

● approximately $ 6.2 million in decreased stock-based compensation expenses due primarily to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted in the six months ended June 30, 2023 ;

• approximately $6.9 million in decreased stock-based compensation expenses due primarily to a reduction in the market price of our common stock, resulting in a lower valuation of equity awards granted ;

• approximately $0.5 million in decreased facility and other expenses;

• approximately $0.4 million in decreased employee related expenses.

Other income, net

For the six months ended June 30, 2023, other income, net was $5.7 million, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

For the six months ended June 30, 2022, other income, net was $1.0 million, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

For the nine months ended September 30, 2023 and September 30, 2022, other income, net was $10.9 million and $2.8 million, respectively, which was primarily attributable to interest income, partially offset by accretion of discounts associated with other marketable securities.

The increase for the nine months ended September 30, 2023 is attributable to increased invested balances and favorable market rates.

Liquidity and Capital Resources

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In June 2023, we completed a public offering in which we sold 12,500,000 shares of our common stock and received net proceeds of approximately $117.1 million after deducting underwriting discounts and commissions and other offering costs.

As of June 30, 2023, we have raised an aggregate of $1.0 billion in net proceeds through the sale of shares of our common stock in public offerings and at-the-market offerings.

As of September 30, 2023, we have raised an aggregate of $1.0 billion in net proceeds through the sale of shares of our common stock in public offerings and at-the-market offerings.

We also have funded our business from payments received under our research collaboration with BMS and our strategic alliance with Allergan, which was terminated in August 2020.

As of June 30, 2023, we had cash, cash equivalents and marketable securities of $480.0 million.

As of September 30, 2023, we had cash, cash equivalents and marketable securities of $446.4 million.

In May 2021, we entered into a common stock sales agreement with Cowen and Company, LLC (“Cowen”), under which we from time to time can issue and sell shares of our common stock through Cowen in at-the-market offerings for aggregate gross sale proceeds of up to $300.0 million (the “ATM Facility”).

As of June 30, 2023, we have not sold any shares of our common stock under the ATM Facility.

In addition to our existing cash, cash equivalents and marketable securities, we are eligible to earn milestone and other payments under our collaboration agreement with BMS.

Our ability to earn the milestone payments and the timing of earning these amounts are dependent upon the timing and outcome of our development, regulatory and commercial activities and, as such, are uncertain at this time.

As of June 30, 2023, our right to contingent payments under our collaboration agreement with BMS is our only significant committed potential external source of funds.

The following table provides information regarding our cash flows for the six months ended June 30, 2023 and 2022 (in thousands):

Six Months Ended

As of September 30, 2023, we have not sold any shares of our common stock under the ATM Facility.

In addition to our existing cash, cash equivalents and marketable securities, we are eligible to earn milestone and other payments under our collaboration agreement with BMS and our other collaboration and license agreements.

Our ability to earn applicable milestone and other payments and the timing of earning these amounts are dependent upon the timing and outcome of development, regulatory and commercial activities and, as such, are uncertain at this time.

As of September 30, 2023, our right to contingent payments under our collaboration agreement with BMS is our only significant committed potential external source of funds.

The following table provides information regarding our cash flows for the nine months ended September 30, 2023 and 2022 (in thousands):

Nine Months Ended

September 30,

Net cash (used in) provided by:

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Financing activities 117,525 665

Net increase (decrease) in cash, cash equivalents, and restricted cash

Net (decrease) increase in cash, cash equivalents, and restricted cash $ (58,984) $ 7,185

Net Cash Used in Operating Activities

The use of cash in all periods resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital.

Net cash used in operating activities was approximately $74.5 million for the six months ended June 30, 2023, which primarily consisted of operating expenses that related to increasing our research efforts, progressing our EDIT-301 program, and supporting business operations.

Net cash used in operating activities was approximately $87.1 million for the six months ended June 30, 2022, which primarily consisted of operating expenses that related to our preclinical and clinical activities, sublicense and license fees, and increased costs as a result of staffing needs due to our expanding operations.

Net Cash Provided by Investing Activities

Net cash provided by investing activities was approximately $36.2 million for the six months ended June 30, 2023, primarily related to proceeds from maturities of marketable securities of $107.6 million, partially offset by costs used to acquire marketable securities of $68.2 million and purchases of property and equipment of $3.2 million.

Net cash provided by investing activities was approximately $52.4 million for the six months ended June 30, 2022, primarily related to proceeds from maturities of marketable securities of $238.8 million, partially offset by costs used to acquire marketable securities of $183.5 million.

Net cash used in operating activities was approximately $109.9 million for the nine months ended September 30, 2023, which primarily consisted of operating expenses that related to increasing our research efforts, the focused progression of clinical and manufacturing activities in support of the EDIT-301 program, and supporting business operations.

Net cash used in operating activities was approximately $135.1 million for the nine months ended September 30, 2022, which primarily consisted of operating expenses that related to our preclinical and clinical activities, sublicense and license fees, and increased staffing costs to support various business operations.

Net Cash Used in Investing Activities

Net cash used in investing activities was approximately $66.6 million for the nine months ended September 30, 2023, primarily related to purchases of marketable securities of $219.8 million, partially offset by the proceeds from the maturities of marketable securities of $156.6 million.

Net cash provided by investing activities was approximately $141.6 million for the nine months ended September 30, 2022, primarily related to proceeds from maturities of marketable securities of $354.8 million, partially offset by costs used to acquire marketable securities of $209.8 million and purchases of property and equipment of $3.5 million.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was approximately $117.5 million for the six months ended June 30, 2023, primarily related to proceeds from offering of common stock of $117.1 million after deducting underwriting discounts and commissions and other offering costs , and proceeds received from issuance of common stock under the employee stock purchase plan of $0.4 million.

Net cash provided by financing activities was approximately $0.6 million for the six months ended June 30, 2022 primarily related to proceeds received from issuance of common stock under our benefit program and exercises of options for our common stock.

Net cash provided by financing activities was approximately $117.5 million for the nine months ended September 30, 2023, primarily related to proceeds from our June 2023 offering of common stock of $117.1 million after deducting underwriting discounts and commissions and other offering costs , and proceeds received from issuance of common stock under the employee stock purchase plan of $0.4 million.

Net cash provided by financing activities was approximately $0.7 million for the nine months ended September 30, 2022 primarily related to proceeds received from issuance of common stock under our employee stock purchase plan and exercises of options for our common stock.

Funding Requirements

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If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts.

We expect that our existing cash, cash equivalents and marketable securities at June 30, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2025.

We expect that our existing cash, cash equivalents and marketable securities at September 30, 2023, will enable us to fund our operating expenses and capital expenditure requirements into third quarter of 2025 .

Our forecast of the period of time through which our existing cash, cash equivalents and investments will be adequate to support our operations is a forward-looking statement and involves significant risks and uncertainties.

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Contractual Obligations

As of June 30, 2023, we had non-cancelable operating leases with future minimum lease payments for a total of $45.3 million, of which $7.0 million will be payable in 2023.

As of September 30, 2023, we had non-cancelable operating leases with future minimum lease payments for a total of $41.9 million, of which $3.7 million will be payable in 2023.

These minimum lease payments exclude our share of the facility operating expenses, real-estate taxes and other costs that are reimbursable to the landlord under the leases.

In the second quarter of 2023, we entered into a license and service agreement pursuant to which we will lease manufacturing space for our continued research and development activities.

As of June 30, 2023, the lease has not

commenced for accounting purposes and it is not expected to commence until the second quarter of 2024.

The lease agreement provides for total remaining lease payments of $87.8 million over a 10-year lease term.

As of September 30, 2023, the lease has not commenced for accounting purposes and it is not expected to commence until the second quarter of 2024.

The license and service agreement provides for total remaining lease payments of up to $87.8 million over a 10-year lease term.

We may terminate the license and service agreement in our discretion upon twelve months' prior written notice.

Our agreements with certain institutions to license intellectual property include potential milestone payments and success fees, sublicense fees, royalty fees, licensing maintenance fees, and reimbursement of patent maintenance costs that we may be required to pay.

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Business—Our Collaborations and Licensing Strategy” in the Annual Report.

We also enter into contracts in the normal course of business with contract research organizations, contract manufacturing organizations and other vendors to assist in the performance of our research and development activities and other services and products for operating purposes.

other services and products for operating purposes.

These contracts generally provide for termination at any time upon prior notice.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis