What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-02 compared with 2023-05-03 · 125 added, 72 removed, 205 unchanged (49% of the section changed)

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We have a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.

Pursuant to our Exclusive Collaboration and License Agreement with Servier (Servier Agreement), we have exclusive rights to ALLO-501 and ALLO-501A, CAR T cell product candidates targeting CD19, in the United States.

Pursuant to our Exclusive Collaboration and License Agreement with Servier (Servier Agreement), we have exclusive rights to ALLO-501 and ALLO-501A, CAR T cell

product candidates targeting CD19, in the United States.

ALLO-501 and ALLO-501A use Cellectis S.A.

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Since inception, we have had significant operating losses.

Our net losses were $98.7 million for the three months ended March 31, 2023.

As of March 31, 2023, we had an accumulated deficit of $1,334.7 million.

As of March 31, 2023, we had $514.0 million in cash and cash equivalents and investments.

Our net losses were $78.0 million and $176.7 million for the three and six months ended June 30, 2023, respectively.

As of June 30, 2023, we had an accumulated deficit of $1.4 billion.

As of June 30, 2023, we had $544.5 million in cash and cash equivalents and investments and we expect our cash runway to fund operations into 2H 2025.

We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses and general and administrative expenses will continue to increase.

Recent Developments

In April 2023, we announced interim data from the TRAVERSE trial.

As of the March 23, 2023 data cutoff, 19 patients were enrolled in the Phase 1 trial, 10 of whom had RCC confirmed to express CD70.

The median time from enrollment to the start of therapy was five days.

In the ongoing dose escalation phase of the TRAVERSE trial, patients will receive lymphodepletion followed by ALLO-316 at one of four cell dose levels (DL1= 40M cells, DL2= 80M cells, DL3=120M cells, DL4= 240M cells).

The data reported to date is primarily from the DL1 and DL2 cohorts.

Anti-tumor activity was primarily observed in patients with tumors confirmed to express CD70.

Among 18 patients evaluable for efficacy, the disease control rate (DCR) was 89%.

In the 10 patients whose tumors were known to express CD70, the disease control rate was 100%, which included three patients who achieved partial remission (two confirmed, one unconfirmed).

The longest response lasted until month eight.

There was a trend toward greater tumor shrinkage in patients with higher levels of CD70 expression.

(n=18) CD70+ Patients

On June 15, 2023, we presented updated data at the International Conference on Malignant Lymphoma (ICML) from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in 33 CAR T naïve patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) treated with the Alloy manufacturing process material across different CAR T dosing and lymphodepletion regimens.

Earlier in June, data from the 12 patients, a subset of these 33 CAR T naïve patients, who received regimen being utilized in ongoing Phase 2 trials was presented at American Society of Clinical Oncology (ASCO) Annual Meeting.

The updated analysis (data cutoff April 20, 2023) of ALPHA/ALPHA2 examined data from all 33 CAR T-naïve patients with r/r LBCL who were treated with a single infusion or consolidation therapy (two planned infusions) of ALLO-501/501A manufactured using the Alloy manufacturing process.

Patients received lymphodepletion with fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) and varying doses of ALLO-647 (from 13 mg/day to 30 mg/day x 3 days).

The median time from enrollment to the start of therapy was three days and 100% of patients received product per specifications.

No patients received bridging therapy.

The dosing breakdown for the 33 patients included in this data set is as follows:

• 12 patients treated with a single dose of ALLO-501/501A and FCA90 lymphodepletion (Phase 2 regimen;

recap of the ASCO 2023 data presentation)

• 6 patients treated with a single dose of ALLO-501/501A and FCA<90 lymphodepletion

• 15 patients treated with consolidation dosing of ALLO-501/501A and split lymphodepletion

CAR T- Naïve Patients with r/r LBCL

Alloy Manufacturing Process

(N=33) Phase 2

Regimen (N=12) FCA<90

(N=6) Consolidation

Dosing (N=15)

Overall Response Rate (ORR), n (%) 19 (58) 8 (67) 3 (50) 8 (53)

Disease Control Rate (DCR), n (%) 16 (89) 10 (100)

There were 19 patients evaluable for safety.

To date, ALLO-316 has demonstrated an adverse event profile generally consistent with autologous CAR T therapies.

One dose-limiting toxicity of Grade 3 autoimmune hepatitis occurred in the second dose level.

Cytokine release syndrome (CRS) was all low-grade with the exception of one Grade 3.

Neurotoxicity, which is now defined more broadly, was generally low grade and reversible with most events being fatigue or headache.

There were no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).

Infections occurred in eight patients of which four were Grade 3+ including one Grade 5 respiratory failure due to Covid-19 infection deemed unrelated to study treatment.

Grade 3+ prolonged cytopenia was observed in three patients (16%).

There were no cases of graft-versus-host disease (GvHD).

Complete Response Rate (CR), n (%) 14 (42) 7 (58) 1 (17) 6 (40)

6 Month Complete Response, n (%) 10 (30) 5 (42) 0 5 (33)

Seven of 12 (58%) patients receiving the Phase 2 regimen achieved a CR and five (42%) maintained a CR through Month 6.

Of the five patients who were in CR at 6 months, four (80%) remained in CR.

The fifth patient had disease progression at 24 months.

The median duration of response was 23.1 months with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months.

Across all 33 patients the CR rate was 42% with 30% maintaining a CR at Month 6.

These results indicating complete responses are more common with lymphodepletion regimens containing 90 mg of ALLO-647 (FCA90).

Median duration of response for both the overall population (n=33) and the patients treated with the Phase 2 regimen (n=12) was 23.1 months.

CAR T- Naïve Patients with r/r LBCL

(N=33) Phase 2

Regimen (N=12) FCA<90

(N=6) Consolidation

CRS 8 (24) 0 4 (33) 0 1 (17) 0 3 (20) 0

Infusion-Related Reaction 1 (5) 0

Neurotoxicity 13 (39) 2 (6) 4 (33) 0 2 (33) 0 7 (47) 2 (13)

ICANS 0 0 0 0 0 0 0 0

GvHD 0 0 0 0 0 0 0 0

IRR 16 (49) 3 (9) 8 (67) 0 3 (50) 1 (17) 5 (33) 2 (13)

Infection 19 (58) 5 (15) 8 (67) 1 (8) 3 (50) 1 (17) 8 (53) 3 (20)

Prolonged Gr3+ Cytopenia — 4 (12) — 2 (17) — 0 — 2 (13)

The Dagger technology, which is a feature of ALLO-316, is designed to resist rejection of AlloCAR T cells by the host immune cells, thereby supporting expansion and enabling a prolonged window of persistence during which AlloCAR T cells can target and destroy cancer cells.

Initial translational data from the TRAVERSE trial demonstrates the suppression of host T cells and marked peak expansion of ALLO-316 despite the relatively low cell doses tested.

In addition to ALLO-316, we plan to deploy Dagger technology to potentially enhance the persistence and activity of next generation AlloCAR T products.

Across the 33 patients, treatment was generally well tolerated with no incidences of Grade 3 or greater cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome or graft versus host disease.

Cytopenia and infections were manageable and comparable to the experience with autologous CAR T cell therapies in patients with r/r LBCL.

The ALPHA/ALPHA2 Phase 1 trials were designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19.

In addition to exploring multiple cell doses, these studies evaluated various doses of ALLO-647, our proprietary lymphodepleting antibody is designed to prevent premature rejection of AlloCAR T cells.

We are currently enrolling the potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in LBCL and expect to complete enrollment in the first half of 2024 with the first data readout planned by the end of 2024.

We are currently enrolling in Canada and expect enrollment in Europe to begin in the third quarter of 2023 and in Australia by year-end.

In addition, we are conducting EXPAND, a trial in which patients with LBCL are randomized to receive a lymphodepletion regimen comprised of fludarabine and cyclophosphamide with or without ALLO-647.

EXPAND is currently open to enrollment in the US and is expected to be open in additional regions in 2023.

Our Research and Development and License Agreements

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Moreover, in December 2022, Servier sent us a notice for material breach due to our purported refusal to allow an audit of certain manufacturing costs under our cost share arrangement.

While we do not believe Servier has such an audit right, we are currently progressing such audit with Servier to recover outstanding manufacturing costs owed by Servier to us.

While we do not believe Servier has such an audit right, we submitted to a review of our manufacturing costs of CD19 Products to recover outstanding manufacturing costs owed by Servier to us.

In July 2023, Servier sent us a second notice for material breach alleging that we overcharged Servier based on Servier and its accounting firm’s review of costs eligible for cost-sharing under the Servier Agreement.

We disagree with the material breach allegations and we are disputing such allegations.

For more information, see “Risk Factors—Servier’s Discontinuation of its involvement in the development of CD19 Products and our disputes with Servier may have adverse consequences."

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On November 1, 2019, we entered into a Collaboration and License Agreement (the Notch Agreement) with Notch Therapeutics Inc.

(Notch), pursuant to which Notch granted us an exclusive, worldwide, royalty-bearing, sublicensable license under certain of Notch’s intellectual property to develop, make, use, sell, import, and otherwise commercialize therapeutic gene-edited T cell and/or natural killer cell products from induced pluripotent stem cells directed at certain CAR targets for initial application in NHL, ALL and multiple myeloma.

In addition, Notch has granted us an option to add certain specified targets to our exclusive license in exchange for an agreed upon per-target option fee.

The Notch Agreement includes a research collaboration to conduct research and pre-clinical development activities to generate engineered cells directed to our exclusive targets, which will be conducted in accordance with an agreed research plan and budget under the oversight of a joint development committee.

In connection with the execution of the Notch Agreement, we made an upfront payment to Notch of $10.0 million.

In connection with the execution of the Notch Agreement,

we made an upfront payment to Notch of $10.0 million.

In addition, we made a $5.0 million investment in Notch’s series seed convertible preferred stock, resulting in us having a 25% ownership interest in Notch’s outstanding capital stock on a fully diluted basis immediately following the investment.

In February 2021, we made an additional $15.9 million investment in

Notch's Series A preferred stock.

In February 2021, we made an additional $15.9 million investment in Notch's Series A preferred stock.

In October 2021, we made an additional $1.8 million investment in Notch's common stock.

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Collaboration and License Agreement with Antion

On January 5, 2022, we entered into an exclusive collaboration and global license agreement (Antion Agreement) with Antion Biosciences SA (Antion) for Antion’s miRNA technology (miCAR), to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products.

Pursuant to the agreement, Antion will exclusively collaborate with us on oncology products for a defined period.

We will also have exclusive worldwide rights to commercialize products incorporating Antion technology developed during the collaboration.

See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Antion Agreement.

On January 5, 2022, we entered into an exclusive collaboration and global license agreement (Antion Collaboration and License Agreement) with Antion Biosciences SA (Antion) for Antion’s miRNA technology (miCAR), to advance multiplex gene silencing as an additional tool to develop next generation allogeneic CAR T products.

On July 11, 2023, we entered into an amendment to the Antion Collaboration and License Agreement, which included a $2 million investment in Antion’s preferred shares and the acquisition of warrants to purchase an additional $3 million of Antion’s preferred shares.

See Note 6 to our condensed consolidated financial statements included elsewhere in this report for further description of the Antion Agreement and the July 2023 amendment.

Components of Results of Operations

As of March 31, 2023, our revenue has been exclusively generated from our collaboration and license agreement with Allogene Overland Biopharm (PRC) Co., Limited.

As of June 30, 2023, our revenue has been exclusively generated from our collaboration and license agreement with Allogene Overland Biopharm (PRC) Co., Limited.

See Note 6 to our financial statements appearing elsewhere in this Quarterly Report for more information related to our recognition of revenue and the Allogene Overland Biopharm (PRC) Co., Limited agreement.

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To date, our research and development expenses have related primarily to discovery efforts, preclinical and clinical development, and manufacturing of our product candidates.

Research and development expenses for the three months ended March 31, 2023 included costs associated with our clinical and preclinical stage pipeline candidates and research into newer technologies.

Research and development expenses for the three and six months ended June 30, 2023 included costs associated with our clinical and preclinical stage pipeline candidates and research into

newer technologies.

The most significant research and development expenses for the year to date relate to costs incurred for the development of our most advanced product candidates and include:

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In addition, the probability of success for each product candidate will depend on numerous factors, including safety, efficacy, competition, manufacturing capability and commercial viability.

We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

We will determine which programs to pursue and

how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

Because our product candidates are still in clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, we may achieve profitability.

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Interest and other income, net consists of interest earned on our cash and cash equivalents and investments, as well as investment gains and losses recognized during the period.

Other Expenses

Other expense consists of non-operating expenses, including our share of equity investments' net losses for the period.

Other Income (Expenses)

Other income (expenses) consists of non-operating income and expenses, including primarily our share of equity investments' net losses for the period.

Results of Operations

Comparison of the Three Months Ended March 31, 2023 and 2022

The following sets forth our results of operations for the three months ended March 31, 2023 and 2022 (dollars in thousands):

Three Months Ended March 31, Change

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

The following sets forth our results of operations for the three months ended June 30, 2023 and 2022 (dollars in thousands):

Three Months Ended June 30, Change

2023 2022 $ %

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Interest and other income, net 3,778 315 3,463 *

Other expenses (1,693) (350) (1,343) 384 %

Total other income (expense), net 366 142 224 158 %

Other (expenses) income (1,249) 1,492 (2,741) *

Total other income, net 2,529 1,807 722 40 %

Net Loss $ (77,989) $ (74,787) $ (3,202) 4 %

* Change in excess of 100%

Collaboration revenue - related party

Collaboration revenue was less than $0.1 million for the three months ended March 31, 2023 and 2022.

Revenue recognized in the three months ended March 31, 2023 and 2022 was due to the delivery of the know-how performance obligations related to the License Agreement entered into with Allogene Overland on December 14, 2020.

Collaboration revenue was less than $0.1 million for the three months ended June 30, 2023 and 2022.

Revenue recognized in the three months ended June 30, 2023 and 2022 was due to the delivery of the know-how performance obligations related to the License Agreement entered into with Allogene Overland on December 14, 2020.

Research and Development Expenses

Research and development expenses were $80.2 million and $60.2 million for the three months ended March 31, 2023 and 2022, respectively.

The increase of $20.1 million was driven primarily by an increase in external costs relating to the advancement of our product candidates due to the timing of development activities and manufacturing runs of $16.9 million and an increase in facilities costs and depreciation expense of $1.6 million.

Research and development expenses were $62.0 million and $57.2 million for the three months ended June 30, 2023 and 2022, respectively.

The increase of $4.9 million was driven primarily by a decrease in Servier cost recoveries of $11.0 million, offset by a decrease in personnel related costs of $5.2 million and a decrease in external costs relating to the advancement of our product candidates due to the timing of development activities and manufacturing runs of $0.9 million.

General and Administrative Expenses

General and administrative expenses were $18.9 million and $19.9 million for the three months ended March 31, 2023 and 2022, respectively.

The decrease of $1.0 million was primarily due to an decrease in personnel related costs of $0.7 million and a decrease in expenses related to corporate communications of $0.3 million.

General and administrative expenses were $18.5 million and $19.5 million for the three months ended June 30, 2023 and 2022, respectively.

The decrease of $1.0 million was primarily due to a decrease in personnel related costs of $0.6 million and a decrease in expenses related to outside services of $0.3 million.

Interest and Other Income, Net

Interest and other income, net was $2.1 million and $0.5 million for the three months ended March 31, 2023 and 2022, respectively.

Interest and other income, net was $3.8 million and $0.3 million for the three months ended June 30, 2023 and 2022, respectively.

The increase of $3.5 million was due to higher yields and a corresponding increase in the interest earned on our cash, cash equivalents and investments.

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

The following sets forth our results of operations for the six months ended June 30, 2023 and 2022 (dollars in thousands):

Six Months Ended June 30, Change

2023 2022 $ %

Collaboration revenue - related party $ 96 $ 147 $ (51) (35) %

Operating expenses:

Research and development 142,276 117,327 24,949 21 %

General and administrative 37,408 39,406 (1,998) (5) %

Total operating expenses 179,684 156,733 22,951 15 %

Loss from operations (179,588) (156,586) (23,002) 15 %

Other income (expense), net:

Interest and other income, net 5,837 807 5,030 *

Other (expenses) income (2,942) 1,142 (4,084) *

Total other income, net 2,895 1,949 946 49 %

Net Loss $ (176,693) $ (154,637) $ (22,056) 14 %

* Change in excess of 100%

Collaboration revenue - related party

Collaboration revenue was $0.1 million for the six months ended June 30, 2023 and 2022.

Revenue recognized in the six months ended June 30, 2023 and 2022 was due to the delivery of the know-how performance obligations related to the License Agreement entered into with Allogene Overland on December 14, 2020.

Research and Development Expenses

Research and development expenses were $142.3 million and $117.3 million for the six months ended June 30, 2023 and 2022, respectively.

The increase of $24.9 million was driven primarily by a decrease in Servier cost recoveries of $16.1 million and an increase in external costs relating to the advancement of our product candidates due to the timing of development activities and manufacturing runs of $11.0 million, offset by a decrease in personnel related costs of $4.4 million.

General and Administrative Expenses

General and administrative expenses were $37.4 million and $39.4 million for the six months ended June 30, 2023 and 2022, respectively.

The decrease of $2.0 million was primarily due to a decrease in personnel related costs of $1.3 million and a decrease in expenses related to outside services of $0.7 million.

Interest and Other Income, Net

Interest and other income, net was $5.8 million and $0.8 million for the six months ended June 30, 2023 and 2022, respectively.

The increase of $5.0 million was due to higher yields and a corresponding increase in the interest earned on our cash, cash equivalents and investments.

Liquidity and Capital Resources

To date, we have incurred significant net losses and negative cash flows from operations.

As of March 31, 2023, we had $514.0 million in cash and cash equivalents and investments.

As of June 30, 2023, we had $544.5 million in cash and cash equivalents and investments.

We anticipate that the aggregate of our current cash and cash equivalents and investments available for operations will be sufficient to fund our operations for at least the next 12 months from the date this Quarterly Report on Form 10-Q is filed with the SEC.

Our operations have been financed primarily by net proceeds from the sale and issuance of our convertible preferred stock, the issuance of convertible promissory notes, net proceeds from our IPO, our at-the-market (ATM) offerings, our June 2020 underwritten public offering, and upfront cash payment of $40.0 million received in December 2020 pursuant to our License Agreement with Allogene Overland.

In connection with our IPO in 2018, we sold an aggregate of 20,700,000 shares of our common stock (inclusive of 2,700,000 shares of common stock pursuant to the over-allotment option granted to the underwriters) at a price of $18.00 per share and received approximately $343.3 million in net proceeds.

In connection with our IPO in 2018, we sold an aggregate of 20,700,000 shares of our common stock (inclusive of 2,700,000 shares of common stock pursuant to the over-allotment option granted to the

underwriters) at a price of $18.00 per share and received approximately $343.3 million in net proceeds.

In November 2019, we entered into a sales agreement with Cowen and Company, LLC (Cowen), as amended on November 2, 2022, under which we may from time to time issue and sell shares of our common stock through Cowen in ATM offerings for an aggregate offering price of up to $250.0 million.

During the year ended December 31, 2019, we sold an aggregate of 1,965,082 shares of common stock in ATM offerings resulting in net proceeds of $54.2 million.

As of March 31, 2023, $167.3 million remains available for sale under the sales agreement with Cowen.

During the year ended December 31, 2020, we sold an aggregate of 848,663 shares of common stock in ATM offerings resulting in net proceeds of $26.2 million.

In June 2023, we sold an aggregate of 20,288,330 shares of common stock in ATM offerings resulting in net proceeds of $87.9 million.

As of June 30, 2023, $77.9 million remains available for sale under the sales agreement with Cowen.

In June 2020, we sold 13,457,447 shares of our common stock, which included 1,755,319 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, in an underwritten public offering at a price of $47.00 per share, which resulted in net proceeds of approximately $595.7 million after deducting the underwriting discounts and commissions and other expenses.

The following table summarizes our cash flows for the periods indicated:

Three Months Ended March 31,

Six Months Ended June 30,

(In thousands)

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Financing activities 91,255 1,838

Net increase (decrease) in cash and cash equivalents and restricted cash $ 48,027 $ (88,800)

Net increase (decrease) in cash, cash equivalents and restricted cash $ 92,854 $ (77,273)

Operating Activities

During the three months ended March 31, 2023, cash used in operating activities of $66.6 million was attributable to a net loss of $98.7 million, partially offset by non-cash charges of $24.7 million and a decrease of $7.4 million in our net operating assets and liabilities.

During the six months ended June 30, 2023, cash used in operating activities of $128.5 million was attributable to a net loss of $176.7 million, partially offset by non-cash charges of $45.2 million and an increase of $3.0 million in our net operating assets and liabilities.

The non-cash charges consisted primarily of stock-based compensation expense of $35.4 million, depreciation of $7.2 million, our share of equity investments' net losses for the period of $2.9 million, net amortization and accretion on investment securities of $0.6 million, and non-cash rent expense of $0.4 million.

The change in operating assets and liabilities was primarily due to a $5.7 million increase in accrued and other current liabilities, a $1.3 million decrease in prepaid expenses and other current assets, and a $1.1 million increase in accounts payable, offset by a $0.6 million decrease in deferred revenue.

During the three months ended March 31, 2022, cash used in operating activities of $68.2 million was attributable to a net loss of $79.9 million, partially offset by non-cash charges of $31.6 million and an increase of $20.0 million in our net operating assets and liabilities.

The non-cash charges consisted primarily of stock-based compensation expense of $22.3 million, our share of equity investments' net losses for the period of $3.8 million, depreciation of $3.7 million, net amortization and accretion on investment securities of $1.3 million, and non-cash rent expense of $0.5 million.

The change in operating assets and liabilities was primarily due to a $9.0 million decrease in accrued and other current liabilities, a $6.7 million increase in prepaid expenses and other current assets, and a $3.1 million increase in other long-term assets, offset by a $0.6 million decrease in other long-term liabilities, and a $0.5 million decrease in accounts payable.

The change in operating assets and liabilities was primarily due to a $5.6 million increase in accrued and other current liabilities and a $1.4 million decrease in prepaid expenses and other current assets, offset by a $3.2 million decrease in accounts payable and a $0.7 million decrease in deferred revenue.

During the six months ended June 30, 2022, cash used in operating activities of $110.8 million was attributable to a net loss of $154.6 million, partially offset by non-cash charges of $58.8 million and an increase of $14.9 million in our net operating assets and liabilities.

The non-cash charges consisted primarily of stock-based compensation expense of $45.2 million, depreciation of $7.4 million, our share of equity investments' net losses for the period of $2.3 million, net amortization and accretion on investment securities of $2.2 million, and non-cash rent expense of $1.6 million.

The change in operating assets and liabilities was primarily due to a $8.5 million increase in prepaid expenses and other current assets, a $3.3 million decrease in accrued and other current liabilities, a $2.8 million increase in other long-term assets, and a $1.6 million decrease in other long-term liabilities, offset by a $0.9 million increase in accounts payable and a $0.4 million increase in deferred revenue.

Investing Activities

During the three months ended March 31, 2023, net cash provided by investing activities of $112.9 million was related to cash provided by investment maturities of $143.4 million and cash provided by proceeds from sales of investments of $5.6 million, offset by cash used in the purchase of investments of $35.1 million and cash used in the purchase of property and equipment of $1.0 million.

During the three months ended March 31, 2022, net cash used in investing activities of $22.4 million was related to cash used in purchases of investments of $89.2 million and cash used in the purchase of property and equipment of $1.9 million, offset by cash provided by investment maturities of $68.7 million.

During the six months ended June 30, 2023, net cash provided by investing activities of $130.1 million was related to cash provided by investment maturities of $296.3 million and cash provided by investment sales of $5.6 million, offset by cash used in purchases of investments of $170.5 million and cash used in the purchase of property and equipment of $1.3 million.

During the six months ended June 30, 2022, net cash provided by investing activities of $31.7 million was related to cash provided by investment maturities of $185.8 million, offset by cash used in purchases of investments of $150.9 million and cash used in the purchase of property and equipment of $3.3 million.

Financing Activities

During the three months ended March 31, 2023, cash provided by financing activities of $1.7 million was related to cash provided by the sale of common stock through our employee stock purchase plan.

During the three months ended March 31, 2022, cash provided by financing activities of $1.8 million was related to $1.5 million of cash provided by the sale of common stock through our employee stock purchase plan and $0.3 million of cash provided by the issuance of common stock upon exercise of stock options.

During the six months ended June 30, 2023, cash provided by financing activities of $91.3 million was related to $87.9 million in net proceeds from the issuance of common stock through ATM transactions, $1.7 million of cash provided by the sale of common stock through our employee stock purchase plan, and $1.6 million of cash provided by the issuance of common stock upon exercise of stock options.

During the six months ended June 30, 2022, cash provided by financing activities of $1.8 million was related to $1.5 million of cash provided by the sale of common stock through our employee stock purchase plan and $0.3 million of cash provided by the issuance of common stock upon exercise of stock options.

Material Cash Commitments and Requirements

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The payment obligations under the license agreements are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones and we will be required to make development milestone payments and royalty payments in connection with the sale of products developed under these agreements.

As of March 31, 2023, we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

As of June 30, 2023, we were unable to estimate the timing or likelihood of achieving the milestones or making future product sales.

For additional information regarding our agreements, see Note 6 to our condensed consolidated financial statements included elsewhere in this report.

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These agreements generally provide for termination or cancellation, other than for costs already incurred.

As of March 31, 2023, the Company had non-cancellable purchase commitments of $0.3 million.

As of June 30, 2023, we had non-cancellable purchase commitments of $0.4 million.

On October 6, 2020, we announced we entered into a strategic five-year collaboration agreement with MD Anderson for the preclinical and clinical investigation of allogeneic CAR T cell product candidates.

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The agreement may be terminated by either party for material breach by the other party.

Individual studies may be terminated for, among other things, material breach, health and safety concerns or where the institutional review board, the review board at the clinical site with oversight of the clinical study, requests termination of any study.

Individual studies may be terminated for, among other things, material breach, health and safety concerns or where the institutional review board, the

review board at the clinical site with oversight of the clinical study, requests termination of any study.

Where any legal or regulatory authorization is finally withdrawn or terminated, the relevant study will also terminate automatically.

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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