What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-08-03 compared with 2022-05-04 · 127 added, 61 removed, 208 unchanged (47% of the section changed)

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The BRILLIANCE trial is designed to assess the safety, tolerability, and efficacy of EDIT-101.

We initially planned to enroll up to 18 patients in the United States and Europe in up to five cohorts, and in 2021 completed dosing of the first three cohorts, the adult low-, mid- and high-dose

We are expanding enrollment in one or more of the previously completed adult cohorts to explore dose response and support establishment of registrational trial endpoints.

We anticipate establishing these registrational trial endpoints by the end of 2022.

In April 2022, we announced the treatment of the first patient in the pediatric mid-dose cohort, and we expect to complete dosing of this cohort in the first half of 2022 and to initiate dosing of the pediatric high-dose cohort later in 2022.

We initially planned to enroll up to 18 patients in the United States and Europe in up to five cohorts, and in the first half of 2022 expanded enrollment in the mid- and high-dose adult cohorts to

explore dose response and support establishment of registrational trial endpoints.

We completed dosing of the first of the three initially planned cohorts, the adult low-, mid- and high-dose cohorts in 2021, and in April 2022, announced the treatment of the first patient in the pediatric mid-dose cohort.

We have completed dosing of the second patient in the pediatric mid-dose cohort and continue to screen and enroll new pediatric patients, and we expect to initiate dosing of the pediatric high-dose cohort in 2022.

We also continue to dose new patients in the expanded adult cohorts, and anticipate designing registrational trial criteria by the end of 2022.

In the third quarter of 2021, we released preliminary clinical data from the first six patients with LCA10 treated with EDIT-101 demonstrating a favorable safety profile and encouraging signals of clinical benefit.

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Business—Our Gene Editing Medicine Programs—In Vivo Gene Editing Medicines - Ocular —Leber Congenital Amaurosis 10” in the Annual Report.

We expect to provide a clinical update on the BRILLIANCE trial in the second half of 2022, including safety and efficacy assessments on all patients who have had at least six months of follow-up evaluations.

We remain on track to provide a clinical update on the BRILLIANCE trial in the second half of 2022, including safety and efficacy assessments on all patients who have had at least six months of follow-up evaluations.

For our ex vivo gene-edited cell medicines, our lead program is EDIT-301, an experimental medicine to treat sickle cell disease, a severe inherited blood disease that causes premature death, and transfusion-dependent beta-thalassemia (“TDT”), the most severe form of beta-thalassemia, another inherited blood disorder characterized by severe anemia.

In January 2021, the U.S.

Food and Drug Administration (the “FDA”) cleared the start of enrollment and dosing of patients in the first phase of our Phase 1/2 clinical trial of EDIT-301, which we refer to as our RUBY trial, for the treatment of sickle cell disease.

This study is designed to validate the safety and beneficial effects of the cell editing process.

The RUBY trial is currently enrolling study participants and is on track to begin dosing in the first half of 2022 with initial clinical results expected by the end of 2022.

Prior to initiating a registrational trial, in response to an FDA partial clinical hold, we will be required to develop a potency assay to ensure that the characteristics of the product released are as expected and confirmed by clinical data collected in the first patients treated.

In November 2021, we filed an Investigational New Drug (“IND”) application for a Phase 1/2 clinical trial of EDIT-301 for the treatment of TDT, which was cleared by the FDA in December 2021.

This trial, referred to as our EdiThal trial, is designed to assess the safety, tolerability, and preliminary efficacy of EDIT-301 for TDT.

Preparations to initiate the trial are underway, and we expect to dose the first TDT patient in 2022.

We dosed the first patient in the RUBY trial in the second quarter of 2022 and have confirmed successful neutrophil and platelet engraftment, indicating that the reinfused cells have been accepted by the patient’s body and have begun to function and create new blood cells as intended.

We are enrolling additional study participants, and have successfully edited cells from patients in preparation for reinfusion.

We remain on track to announce top-line clinical data by the end of 2022.

In July 2022, the FDA removed the previously disclosed partial clinical hold on the RUBY trial.

This enables us to include efficacy data from patients in a marketing application for EDIT-301 in the future.

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.

This trial, referred to as our EDITHAL trial, is designed to assess the safety, tolerability, and preliminary efficacy of EDIT-301 for the treatment of TDT.

Preparations to initiate this trial are underway, and we remain on track to dose the first TDT patient in 2022.

In May 2022, the FDA granted Orphan Drug Designation to EDIT-301 for the treatment of TDT.

In cellular therapy medicines, we continue to develop our capabilities to generate cells from induced human pluripotent stem cells to develop engineered cell medicines to treat cancer.

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Since inception, we have incurred significant operating losses.

Our net losses were $50.5 million and $56.7 million for the three months ended March 31, 2022 and 2021, respectively.

As of March 31, 2022, we had an accumulated deficit of $908.2 million.

Our net losses were $104.0 million and $112.0 million for the six months ended June 30, 2022 and 2021, respectively.

As of June 30, 2022, we had an accumulated deficit of $961.7 million.

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

Our net losses may fluctuate significantly from quarter to quarter and from year to year.

anticipate that our expenses will increase substantially as we continue our current research programs and our preclinical development activities;

We anticipate that our expenses will increase substantially as we continue our current research programs and our preclinical development activities;

progress the clinical development of EDIT-101 and EDIT-301;

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We do not expect to be profitable for the year ending December 31, 2022 or the foreseeable future.

Although we did not experience any significant impact on our financial condition, results of operations or liquidity due to the ongoing COVID-19 pandemic during the three months ended March 31, 2022, the pandemic has continuously evolved with new, more contagious, variants emerging from time to time, and near-term risks to our business remain.

Although we did not experience any significant impact on our financial condition, results of operations or liquidity due to the ongoing COVID-19 pandemic during the six months ended June 30, 2022, the pandemic has continuously evolved with new, more contagious, variants emerging from time to time, and near-term risks to our business remain.

In response to COVID-19 and these variants, governments have implemented a variety of responses, including government-imposed quarantines, travel restrictions and other public health safety measures.

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Centers for Disease Control and Prevention and the Commonwealth of Massachusetts and the State of Colorado, the jurisdictions in which we primarily operate our business, to protect the health and safety of our employees and the community.

In March 2020, in light of the COVID-19 pandemic, we implemented a work from home policy, and restricted on-site activities at our facilities in Massachusetts and Colorado to certain manufacturing, laboratory and related support activities.

Under our return to onsite work plans, we gradually resumed manufacturing, laboratory and related support activities at our facilities in Massachusetts and Colorado, and fully reopened our facilities in the third quarter of 2021 using a hybrid work model.

Since fully reopening our facilities, we have when needed temporarily reimposed the work from home policy and on-site activity restrictions in response to local increases in COVID-19 cases, and may do so again in the future as appropriate.

After previously implementing a work from home policy and restricting on-site activities at our facilities in Massachusetts and Colorado, we fully reopened these facilities in the third quarter of 2021 using a hybrid work model.

We have when needed reimposed the work from home policy and on-site activity restrictions in response to local increases in COVID-19 cases, and may do so again in the future as appropriate.

We will continue to monitor and respond to the changing conditions created by the pandemic, with focus on prioritizing the health and safety of our employees and maintaining safe and reliable operations of our facilities.

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We no longer receive research funding support.

As of March 31, 2022, we recorded $62.3 million of deferred revenue in relation to our collaboration with BMS, of which $56.7 million is classified as long-term on our condensed consolidated balance sheet.

As of June 30, 2022, 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 any other collaborations or agreements we may 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 agreements we enter into.

Research and Development Expenses

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Research and development activities are central to our business model.

We expect research and development costs to increase significantly for the foreseeable future as our development programs progress, including as we continue to progress the clinical development of EDIT-101 and EDIT-301 as well as supporting preclinical studies for our other research programs.

We expect research and development costs to increase significantly for the foreseeable future as our development programs progress, including as we continue to progress the clinical development of EDIT-101 and EDIT-301 as well as support preclinical studies for our other research programs.

General and Administrative Expenses

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Other Income, Net

For the three months ended March 31, 2022 and 2021, other income, net consisted primarily of interest income, partially offset by accretion of discounts associated with other marketable securities.

For the six months ended June 30, 2022 and 2021, 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 March 31, 2022 and 2021

The following table summarizes our results of operations for the three months ended March 31, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Comparison of the Three Months ended June 30, 2022 and 2021

The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

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Other income, net:

Other (expense) income, net

Other income (expense), net

Interest income, net

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Collaboration and other research and development revenues

Collaboration and other research and development revenues increased by $0.3 million, to $6.8 million for the three months ended March 31, 2022, compared to $6.5 million for three months ended March 31, 2021.

The revenue recognized during the first quarter of 2022 and 2021 is primarily related to BMS exercising its option to an additional program.

Collaboration and other research and development revenues increased by $6.0 million, to $6.4 million for the three months ended June 30, 2022, compared to $0.4 million for three months ended June 30, 2021.

This increase was primarily attributable to BMS’s exercise in the second quarter of 2022 of its option to an additional program under our collaboration with BMS.

Research and development expenses

Research and development expenses decreased by $3.9 million, to $38.0 million for the three months ended March 31, 2022, compared to $41.9 million for the three months ended March 31, 2021.

The following table summarizes our research and development expenses for the three months ended March 31, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Research and development expenses increased by $9.9 million, to $43.7 million for the three months ended June 30, 2022, compared to $33.8 million for the three months ended June 30, 2021.

The following table summarizes our research and development expenses for the three months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

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Stock-based compensation expenses

Other expenses

Sublicense and license fees

Other expenses

Total research and development expenses

The decrease in research and development expenses for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was primarily attributable to:

● approximately $8.0 million in decreased sublicense and license fees primarily related to the achievement of success payments under one of our license agreements in the first quarter of 2021 for which there was no similar activity in the first quarter of 2022;

● approximately $0.3 million in decreased stock-based compensation expenses.

These decreases were partially offset by:

The increase in research and development expenses for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily attributable to:

● approximately $6.1 million in increased external research and development expenses related primarily to the clinical and manufacturing development of EDIT-101, EDIT-301 and our other programs;

● approximately $2.0 million in increased employee-related expenses primarily due to an increase in the size of our workforce, including the expansion of our research and development organization;

● approximately $1.0 million in increased external research and development expenses related primarily the clinical and manufacturing development of EDIT-101, EDIT-301 and our other programs;

● approximately $0.7 million in increased facility related expenses;

● approximately $1.9 million in increased sublicense and license expenses, primarily due to license obligations related to a clinical milestone achievement, in addition to sublicense fees owed in connection with an out-license arrangement;

● approximately $0.7 million in increased other expenses;

● approximately $0.4 million in increased facility related expenses.

These increases were partially offset by:

● approximately $1.1 million in decreased stock-based compensation expenses primarily due to a one-time equity award granted in 2021, for which there was no similar award in 2022.

General and administrative expenses

General and administrative expenses decreased by $1.9 million, to $19.5 million for the three months ended March 31, 2022, compared to $21.4 million for the three months ended March 31, 2021.

The following table summarizes our general and administrative expenses for the three months ended March 31, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

General and administrative expenses decreased by $5.1 million, to $16.9 million for the three months ended June 30, 2022, compared to $22.0 million for the three months ended June 30, 2021.

The following table summarizes our general and administrative expenses for the three months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Three Months Ended

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Percentage Change

Employee related expenses

Stock-based compensation expenses

Intellectual property and patent related fees

Facility and other expenses

Professional service expenses

Total general and administrative expenses

The decrease in general and administrative expenses for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily attributable to:

● approximately $5.8 million in decreased stock-based compensation expense primarily related to performance awards granted in 2021 to our former Chief Executive Officer that were achieved or deemed probable in the second quarter of 2021, for which there was no similar expense in the second quarter of 2022;

● approximately $1.3 million in decreased intellectual property and patent-related fees primarily resulting from decreased legal fees related to the prosecution and maintenance of our patents;

● approximately $0.1 million in decreased employee related expenses.

These decreases were partially offset by:

● approximately $1.3 million in increased professional service expenses;

● approximately $0.9 million in increased facility and other expenses.

Other income, net

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

For the three months ended June 30, 2021, other income, net was $0.1 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, 2022 and 2021

The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

Collaboration and other research and development revenues

Operating expenses:

Research and development

General and administrative

Total operating expenses

Other income, net

Interest income, net

Total other income, net

Collaboration and other research and development revenues

Collaboration and other research and development revenues increased by $6.2 million, to $13.1 million, for the six months ended June 30, 2022 from $6.9 million for six months ended June 30, 2021.

This increase was primarily attributable to BMS’s exercise in the second quarter of 2022 of its option to an additional program under our collaboration with BMS.

Research and development expenses

Research and development expenses increased by $5.9 million, to $81.6 million, for the six months ended June 30, 2022 from $75.7 million for the six months ended June 30, 2021.

The following table summarizes our research and development expenses for the six months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

External research and development expenses

Employee related expenses

Facility expenses

Stock-based compensation expenses

Other expenses

Sublicense and license fees

Total research and development expenses

The increase in research and development expenses for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 was primarily attributable to:

● approximately $7.1 million in increased external research and development expenses primarily attributable to the clinical and manufacturing development of EDIT-101, EDIT-301 and our other programs;

● approximately $4.0 million in increased employee related expenses primarily due to an increase in the size of our workforce, including the expansion of our research and development organization;

● approximately $1.3 million in increased other expenses;

● approximately $1.1 million in increased facility related expenses primarily related to increased lab and manufacturing space.

These increases were partially offset by:

● approximately $6.1 million in decreased sublicense and license fees primarily related to the triggering of success payments under certain of our license agreements upon the achievement of market capitalization based milestones in the first quarter of 2021 for which there were no similar fees in 2022;

● approximately $1.4 million in decreased stock-based compensation expenses primarily due to a one-time equity award granted in 2021, for which there was no similar award in 2022.

General and administrative expenses

General and administrative expenses decreased by $7.0 million, to $36.5 million, for the six months ended June 30, 2022 from $43.5 million for the six months ended June 30, 2021.

The following table summarizes our general and administrative expenses for the six months ended June 30, 2022 and 2021, together with the changes in those items in dollars (in thousands) and the respective percentages of change:

Six Months Ended

Dollar Change

Percentage Change

Stock-based compensation expenses

Employee related expenses

Intellectual property and patent related fees

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Total general and administrative expenses

The decrease in general and administrative expenses for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was primarily attributable to:

The decrease in general and administrative expenses for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 was primarily attributable to:

● approximately $6.3 million in decreased stock-based compensation expense related to the acceleration of vesting of certain equity awards held by our former Chief Executive Officer in connection with her separation from our company in February 2021, as well as stock-based compensation expense recognized related to the performance-based awards that were granted to our new Chief Executive Officer and other certain employees in 2021, under which a single performance obligation was achieved and fully recognized in 2021, for which there were no similar expenses recognized in 2022;

● approximately $3.0 million in decreased intellectual property and patent related fees primarily resulting from decreased legal fees related to the prosecution and maintenance of our patents;

● approximately $0.7 million in decreased employee related expenses.

● approximately $0.5 million in decreased stock-based compensation expense.

These decreases were partially offset by:

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Other income, net

For the three months ended March 31, 2022 and 2021, other income, net was $0.2 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 six months ended June 30, 2021, other income, net was $0.3 million, which was primarily attributable to interest income partially offset by accretion of discounts associated with other marketable securities.

Liquidity and Capital Resources

Sources of Liquidity

As of March 31, 2022, we have raised an aggregate of $898.0 million in net proceeds through the sale of shares of our common stock in public offerings and at-the-market offerings.

As of June 30, 2022, we have raised an aggregate of $898.0 million 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 March 31, 2022, we had cash, cash equivalents and marketable securities of $566.4 million.

As of June 30, 2022, we had cash, cash equivalents and marketable securities of $527.6 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 March 31, 2022, we have not sold any shares of our common stock under the ATM Facility.

As of June 30, 2022, 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 March 31, 2022, 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 three months ended March 31, 2022 and 2021 (in thousands):

Three Months Ended

As of June 30, 2022, 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, 2022 and 2021 (in thousands):

Six Months Ended

Net cash (used in) provided by:

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Financing activities

Net increase in cash, cash equivalents, and restricted cash

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

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 $49.2 million for the three months ended March 31, 2022, which primarily consisted of operating expenses that relate to our on-going preclinical and clinical activities, patent costs and license fees, and increased costs as a result of staffing needs due to our expanding operations.

Net cash used in operating activities was approximately $49.5 million for the three months ended March 31, 2021, which primarily consisted of operating expenses that relate to our on-going preclinical and clinical activities, patent costs and license fees, and increased costs as a result of staffing needs due to our expanding 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 relate to our on-going preclinical and clinical activities, sublicense and license fees, and increased costs as a result of staffing needs due to our expanding operations.

Net cash used in operating activities was approximately $88.4 million for the six months ended June 30, 2021, which primarily consisted of operating expenses that relate to our on-going preclinical and clinical activities, patent costs and license fees, and increased costs as a result of staffing needs due to our expanding operations.

These expenses were partially offset by cash inflows from license fees received in the period.

Net Cash Provided by Investing Activities

Net cash provided by investing activities was approximately $56.4 million for the three months ended March 31, 2022, primarily related to proceeds from maturities of marketable securities of $119.0 million, partially offset by costs used to acquire marketable securities of $60.4 million.

Net cash provided by investing activities was approximately $3.2 million for the three months ended March 31, 2021, primarily related to proceeds from maturities of marketable securities of $130.8 million partially offset by costs used to acquire marketable securities of $127.4 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 provided by investing activities was approximately $8.0 million for the six months ended June 30, 2021, primarily related to proceeds from maturities of marketable securities of $205.0 million, partially offset by costs used to acquire marketable securities of $194.2 million and purchases of property and equipment of $2.8 million.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was approximately $0.2 million for the three months ended March 31, 2022 primarily related to proceeds received from exercises of options for our common stock.

Net cash provided by financing activities was approximately $261.5 million for the three months ended March 31, 2021 and consisted of $249.5 million in net proceeds received from the offering of our common stock and $12.0 million in proceeds received from exercises of options for our common stock.

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 $278.6 million for the six months ended June 30, 2021 and consisted of $249.5 million in net proceeds received from a public offering of our common stock and $28.6 million in proceeds received from exercises of options for our common stock.

Funding Requirements

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initiate preclinical testing and clinical trials for other product candidates we identify and develop, including preparing for and initiating the clinical development of EDIT-301 for the treatment of TDT;

maintain, expand, and protect our intellectual property portfolio, including reimbursing our licensors for expenses related to the intellectual property that we in-license from such licensors;

maintain, expand, and protect our intellectual property portfolio,

including reimbursing our licensors for expenses related to the intellectual property that we in-license from such licensors;

hire additional clinical, quality control, and scientific personnel;

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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 March 31, 2022 will enable us to fund our operating expenses and capital expenditure requirements into early 2024.

We expect that our existing cash, cash equivalents and marketable securities at June 30, 2022 will enable us to fund our operating expenses and capital expenditure requirements into 2024.

Our forecast of the period of time through which our existing cash and 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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● the scope, progress, results, and costs of drug discovery, preclinical development, laboratory testing, and clinical or natural history study trials for the product candidates we develop;

● the costs of progressing the clinical development of EDIT-101 to treat LCA10, including expanding trial enrollment to explore dose response and support establishment of registrational trial endpoints;

● the costs of progressing the clinical development of EDIT-301 to treat sickle cell disease and preparing for

and initiating the clinical development of EDIT-301 to treat TDT;

● the costs of progressing the clinical development of EDIT-101 to treat LCA10, including the expansion of trial enrollment to explore dose response and support establishment of registrational trial endpoints;

● the costs of progressing the clinical development of EDIT-301 to treat sickle cell disease and preparing for and initiating the clinical development of EDIT-301 to treat TDT;

● the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending intellectual property-related claims;

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● the costs of operating as a public company.

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive, and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales.

necessary data or results required to obtain marketing approval and achieve product sales.

In addition, any product candidate that we identify and develop, if approved, may not achieve commercial success.

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Contractual Obligations

As of March 31, 2022, we had non-cancelable operating leases with future minimum lease payments for a total of $25.4 million, of which $8.3 million will be payable in 2022.

As of June 30, 2022, we had non-cancelable operating leases with future minimum lease payments for a total of $22.0 million, of which $4.9 million will be payable in 2022.

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.

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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