What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-05-07 compared with 2023-11-07 · 123 added, 187 removed, 211 unchanged (60% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included in Part I, Item 1, of this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2023 (“Form 10-Q”) and with the audited consolidated financial statements and the related notes for the fiscal year ended December 31, 2022 included in our Annual Report on Form 10-K (“Form 10-K”) filed with the U.S.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included in Part I, Item 1, of this Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 (“Form 10-Q”) and with the audited consolidated financial statements and the related notes for the fiscal year ended December 31, 2023 included in our Annual Report on Form 10-K (“Form 10-K”) filed with the U.S.

Securities and Exchange Commission (“SEC”) on March 11, 2024.

Special Note Regarding Forward-Looking Statements

This Form 10-Q contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

This Form 10-Q contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”).

All statements other than statements of historical facts contained in this Form 10-Q are forward-looking statements, including statements regarding our business strategy, plans, and objectives;

18 unchanged sentences

risks related to our reliance on third parties to conduct our clinical trials and manufacture our product candidates;

risks caused by public health crises such as the COVID-19 pandemic or geopolitical events on our business and operations;

risks caused by public health crises or geopolitical events on our business and operations;

and other risks described in greater detail in the section of our Form 10-K titled “Risk Factors,” and in other filings we make with the SEC.

3 unchanged sentences

We are a clinical-stage C lustered R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”) genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.

Our genome-editing platform, including our novel chRDNA ( C RISPR h ybrid R NA- DNA , or “chRDNA,” pronounced “chardonnay”) technology, enables superior editing precision to develop cell therapies that are armored to improve antitumor activity.

Our genome-editing platform, including our novel chRDNA ( C RISPR h ybrid R NA- DNA , or “chRDNA,” pronounced “chardonnay”) technology, enables more precise genome editing to develop cell therapies that are armored to improve activity against diseases.

We are advancing a pipeline of allogeneic, or off-the-shelf, cell therapies from our chimeric antigen receptor (“CAR”) T (“CAR-T”) cell and CAR-natural killer (“CAR-NK”) cell platforms as readily available therapeutic treatments for patients.

We are initially focused on advancing multiple allogeneic cell therapies for the treatment of hematologic malignancies and solid tumors.

Our therapies are directed at established tumor cell surface targets for which autologous CAR-T cell therapeutics have already demonstrated clinical proof of concept, including CD19 and B cell maturation antigen (“BCMA”), as well as targets such as C-type lectin-like molecule-1 (“CLL-1,” also known as CD371).

chRDNA technologies to armor our cell therapies by using multiple genome-editing strategies, such as checkpoint disruption, immune cloaking, or a combination of these two strategies to enhance their antitumor activity.

Our lead product candidate, CB-010, to our knowledge, is the first clinical-stage allogeneic anti-CD19 CAR-T cell therapy with programmed cell death protein 1 (“PD-1”) removed from the CAR-T cell surface by a genome-edited knockout of the PDCD1 gene.

We have demonstrated in preclinical models that the PD-1 knockout improved the durability of antitumor activity by disrupting a pathway that leads to rapid T cell exhaustion.

CB-010 is being evaluated in our ongoing ANTLER phase 1 clinical trial in patients with relapsed or refractory B cell non-Hodgkin lymphoma (“r/r B-NHL”).

We completed the dose escalation portion of the ANTLER trial and advanced into the dose expansion portion, and we are enrolling second-line large B cell lymphoma (“LBCL”) patients to determine the recommended phase 2 dose.

CB-010 has received Regenerative Medicine Advanced Therapy (“RMAT”) designation for r/r LBCL and Fast Track designation for r/r B-NHL from the U.S.

We are currently focused on advancing our allogeneic cell therapies for the treatment of hematologic malignancies and autoimmune diseases.

Our therapies are directed at established cell surface targets for which autologous CAR-T cell therapeutics have already demonstrated clinical proof of concept, including CD19 and B cell maturation antigen (“BCMA”), as well as targets such as C-type lectin-like molecule-1 (“CLL-1,” also known as CD371).

chRDNA technologies to armor our cell therapies through multiple genome-editing strategies, such as checkpoint disruption, immune cloaking, or a combination of these two strategies to enhance activity against devastating diseases.

Our lead product candidate, CB-010, is an allogeneic CAR-T cell therapy that is, to our knowledge, the first anti-CD19 allogeneic, or off-the-shelf, CAR-T cell therapy to be evaluated in patients with second-line relapsed or refractory large B cell lymphoma (“r/r LBCL”) .

To our knowledge, CB-010 is also the first clinical-stage allogeneic anti-CD19 CAR-T cell therapy with programmed cell death protein 1 (“PD-1”) removed from the CAR-T cell surface by a genome-edited knockout of the PDCD1 gene.

CB-010 is being evaluated in our ongoing ANTLER phase 1 clinical trial.

In the dose escalation portion of our ANTLER clinical trial, three dose levels of CB-010 were evaluated:

dose level 1 (40x10 6 viable CAR-T cells, n=8), dose level 2 (80x10 6 viable CAR-T cells, n=5), and dose level 3 (120x10 6 viable CAR-T cells, n=3).

CB-010 was generally well-tolerated with adverse events as expected for anti-CD19 CAR-T cell therapies.

Based on these encouraging dose escalation data, we are evaluating CB-010 in adult second-line LBCL patients in the dose expansion portion of the ongoing ANTLER trial.

Additionally, based on a retrospective analysis of the ANTLER data, we intend to investigate partial human leukocyte antigen matching and donor-specific antibody screening for CB-010 and our other CAR-T programs.

An abstract on the ANTLER phase 1 clinical trial has been accepted for a poster presentation on June 3, 2024, at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, and we plan to present initial dose expansion data, the recommended phase 2 dose (“RP2D”) in second-line LBCL patients, and emerging translational data.

CB-010 has received regenerative medicine advanced therapy (“RMAT”) designation for r/r LBCL, fast track designation for relapsed or refractory B cell non-Hodgkin lymphoma (“r/r B-NHL”), and orphan drug designation for follicular lymphoma (“FL”) from the U.S.

Food and Drug Administration (“FDA”).

Additionally, CB-010 has received orphan drug designation from the FDA for follicular lymphoma.

On July 13, 2023, we announced results of the long-term follow-up from the dose escalation portion of the ongoing ANTLER phase 1 trial evaluating our CB-010 product candidate.

We plan to meet with the FDA by year end 2023 to discuss a potential pivotal clinical trial for CB-010 in second-line LBCL patients, and we plan to share FDA feedback by year-end 2023.

CB-010 is, to our knowledge, the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in second-line LBCL patients.

We also plan to report initial dose expansion data in second-line LBCL patients from the ongoing ANTLER trial in the first half of 2024.

Our second product candidate, CB-011, is an allogeneic CAR-T cell therapy that targets BCMA.

CB-011 is, to our knowledge, the first anti-BCMA CAR-T cell therapy incorporating an immune cloaking approach that includes both the removal of the endogenous beta-2 microglobulin (“B2M”) protein by a genome-edited knockout of the B2M gene and insertion of a B2M–human-leukocyte-antigen-E–peptide transgene (“B2M–HLA-E”), enabling expression of HLA-E on the CAR-T cell surface.

We are expanding our clinical development of CB-010 to include autoimmune diseases, and we recently received clearance of our investigational new drug (“IND”) application from the FDA for CB-010 to be evaluated in adult patients with lupus nephritis (“LN”) and extrarenal lupus (“ERL”) in our multicenter, open label, GALLOP phase 1 clinical trial, which we expect to initiate by year-end 2024.

Our second product candidate, CB-011, is an allogeneic CAR-T cell therapy that is, to our knowledge, the first anti-BCMA CAR-T cell therapy incorporating an immune cloaking approach that includes both the removal of the endogenous beta-2 microglobulin (“B2M”) protein and insertion of a beta-2-microglobulin–human-leukocyte-antigen-E–peptide transgene (“B2M–HLA-E”).

This strategy is designed to reduce CAR-T cell rejection by both patient T cells and natural killer (“NK”) cells to potentially enable more durable antitumor activity.

CB-011 is being evaluated in our ongoing CaMMouflage phase 1 clinical trial in patients with relapsed or refractory multiple myeloma (“r/r MM”).

CB-011 has received Fast Track designation for r/r MM from the FDA.

We plan to provide updates on dose escalation as the CaMMouflage phase 1 trial advances.

Our third product candidate, CB-012, is an allogeneic CAR-T cell therapy targeting CLL-1.

CB-011 is being evaluated in our CaMMouflage phase 1 clinical trial in adult patients with relapsed or refractory multiple myeloma (“r/r MM”), and we are currently enrolling patients in the dose escalation portion of the CaMMouflage trial.

CB-011 was granted fast track and orphan drug designations for r/r MM from the FDA.

The third product candidate from our CAR-T cell platform is CB-012, an allogeneic CAR-T cell therapy targeting CLL-1 (also known as CD371).

CB-012 is, to our knowledge, the first allogeneic CAR-T cell therapy with both checkpoint disruption and immune cloaking strategies.

We believe that CLL-1 is an attractive target for acute myeloid leukemia (“AML”) due to its expression on myeloid cancer cells, its enrichment in leukemic stem cells, and its absence on hematopoietic stem cells (“HSCs”).

We have received clearance of our CB-012 investigational new drug application (“IND”) from the FDA.

CB-012 will be evaluated in the AMpLify phase 1 clinical trial for patients with relapsed or refractory AML (“ r/r AML”).

We are developing allogeneic CAR-NK cell therapies derived from genome-edited induced pluripotent stem cells (“iPSCs”) for the treatment of solid tumors.

CB-020 is our first CAR-NK product candidate from our CAR-NK platform and we have selected receptor tyrosine kinase like orphan receptor 1 (“ROR1”) as the tumor cell-surface target for CB-020.

CB-020 and potential future CAR-NK cell therapy product candidates will contain genome edits designed to overcome some of the challenges of targeting solid tumors, such as trafficking, tumor infiltration, tumor heterogeneity, and the immunosuppressive tumor microenvironment.

We believe that CLL-1 is an attractive target for acute myeloid leukemia (“AML”) due to its expression on myeloid cancer cells, its enrichment on leukemic stem cells, and its absence on hematopoietic stem cells (“HSCs”).

CB-012 is being evaluated in our AMpLify phase 1 clinical trial in adult patients with relapsed or refractory AML (“r/r AML”), and we are currently enrolling patients in the dose escalation portion of the AMpLify trial.

Since our founding in 2011, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, expanding our genome-editing platform technologies, developing our product candidates and building our pipeline, creating and maintaining our intellectual property portfolio, and establishing arrangements with third parties for the manufacture, testing, and clinical trial evaluations of our product candidates.

We do not have any products approved for commercial sale and have not generated any revenue from product sales.

We have incurred net losses since commencement of our operations.

We have incurred operating losses since commencement of our operations.

To date, we have primarily funded our operations through proceeds from the sales of our capital stock, revenue from our license and collaboration agreements, and proceeds from the sale of shares of Intellia Therapeutics, Inc.

(“Intellia”) common stock.

Our net losses for the three months ended September 30, 2023, and 2022 were $10.0 million and $26.6 million, respectively.

Our net losses for the nine months ended September 30, 2023, and 2022 were $67.6 million and $72.4 million, respectively.

We had an accumulated deficit of $264.8 million as of September 30, 2023.

Our net losses for the three months ended March 31, 2024, and 2023 were $41.2 million and $28.0 million, respectively.

We had an accumulated deficit of $340.5 million as of March 31, 2024.

Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of expenses associated with our clinical trials and nonclinical studies and our other research and development expenses.

We anticipate that our expenses will increase substantially if and as we:

• advance the ANTLER phase 1 clinical trial for our CB-010 product candidate, the CaMMouflage phase 1 clinical trial for our CB-011 product candidate, and the AMpLify phase 1 clinical trial for our CB-012 product candidate;

• continue our current research programs and our preclinical and clinical development of our other current product candidates, including CB-020 and any other product candidates we identify and choose to develop;

• hire additional clinical, quality control, regulatory, technical operations, and scientific personnel;

We anticipate that our expenses will increase substantially as we:

• advance clinical trials for our CAR-T cell therapy product candidates;

• continue our current research programs and our preclinical and clinical development of our other current product candidates and any other product candidates we identify and choose to develop;

• hire additional clinical, quality control, regulatory, and scientific personnel;

• seek to identify additional research programs and additional product candidates;

5 unchanged sentences

• add operational, legal, financial, and management information systems and personnel;

• experience any delays, challenges, or other issues associated with any of the above, including the failure of clinical trials meeting endpoints, unanticipated preclinical results or clinical trial data subject to differing interpretations, or the occurrence of potential safety issues or other development or regulatory challenges;

• experience any delays, challenges, or other issues associated with any of the above, including the failure of clinical trials meeting endpoints, the generation of unanticipated preclinical results or clinical trial data subject to differing interpretations, or the occurrence of potential safety issues or other development or regulatory challenges;

• make royalty, milestone, or other payments under current, and any future, in-license or assignment agreements;

• establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval;

• establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we obtain regulatory approval;

• continue to operate as a public company.

We do not own or operate any manufacturing facilities.

We use multiple contract manufacturing organizations (“CMOs”) to individually manufacture, under current good manufacturing processes, chRDNA guides, Cas9 and Cas12a proteins, plasmids, and adeno-associated virus serotype 6 vectors used in the manufacture of our cell therapy product candidates as well as the CAR-T and CAR-NK cell therapy product candidates themselves.

We use multiple contract manufacturing organizations (“CMOs”) to individually manufacture, under current good manufacturing processes, our chRDNA guides, Cas9 and Cas12a proteins, plasmids, and adeno-associated virus serotype 6 (“AAV6”) vectors used in the manufacture of our cell therapy product candidates as well as the CAR-T and CAR-NK cell therapy product candidates themselves.

We expect to continue to rely on our CMOs for the manufacturing of our preclinical study and clinical trial materials, and most of these CMOs have capabilities for commercial manufacturing.

Additionally, we may decide to build our own manufacturing facility in the future to provide greater flexibility and control over our clinical or commercial manufacturing needs.

Additionally, we may decide to bring certain manufacturing functions in house and/or build our own manufacturing facility in the future to provide greater flexibility and control over our clinical and commercial manufacturing needs.

Because of the numerous risks and uncertainties associated with therapeutic product development, we may never achieve profitability and, unless and until we are able to develop and commercialize our product candidates, we will need to continue to raise additional capital.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings (including our at-the-market facility), debt financings, collaborations and strategic alliances, licensing arrangements, or other sources.

Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings (including our at-the-market equity offering program), debt financings, collaborations and strategic alliances, licensing arrangements, or other sources.

There are no assurances that we will be successful in obtaining an adequate level of financing to support our business plans as needed on acceptable terms, or at all.

15 unchanged sentences

Each of these payments results in licensing and collaboration revenue.

Revenue under such licensing and collaboration agreements was $23.7 million and $3.3 million for the three months ended September 30, 2023, and 2022, respectively, and $30.9 million and $10.2 million for the nine months ended September 30, 2023, and 2022, respectively.

See Notes 4, 5, and 7 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q.

Revenue under such licensing and collaboration agreements was $2.4 million and $3.5 million for the three months ended March 31, 2024, and 2023, respectively.

See Notes 4, 5, and 7 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.

For additional information about our revenue recognition policy related to our licensing and collaboration agreements, see Note 2 to the consolidated financial statements included in our Form 10-K.

2 unchanged sentences

Research and Development Expenses

Our research and development expenses consist of internal and external expenses incurred in connection with the development of our product candidates and our platform technologies, and our in-licensing and assignment agreements.

External costs include:

• costs associated with acquiring technology and intellectual property licenses that have no alternative future uses, sublicensing revenue, and milestones under our licensing agreements;

• costs incurred in connection with the preclinical and clinical development and manufacturing of our product candidates, including under agreements with contract research organizations (“CROs”), CMOs, and clinical sites;

• costs associated with acquiring technology and intellectual property licenses that have no alternative future uses, sublicensing revenues, and milestones;

• costs incurred in connection with the preclinical and clinical development and manufacturing of our product candidates, including under agreements with CMOs, suppliers, clinical research organizations (“CROs”), and clinical sites;

• other research and development costs, including laboratory materials and supplies, and consulting services.

4 unchanged sentences

Costs of certain activities are recognized based on an evaluation of the progress to completion of specific tasks.

However, payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets on our condensed consolidated balance sheets.

The capitalized amounts are recognized as expenses as the goods are delivered or as related services are performed.

4 unchanged sentences

We expect that our research and development expenses will increase substantially for the foreseeable future as we continue to implement our business strategy;

advance our CB-010 and CB-011 product candidates through clinical trials and later stages of development;

advance our product candidates through clinical trials and later stages of development;

conduct preclinical studies and clinical trials for our other product candidates;

2 unchanged sentences

and seek to identify, in-license, acquire, and/or develop additional product candidates.

The successful development of our CB-010, CB-011, CB-012, and CB-020 product candidates, as well as other potential future product candidates, is highly uncertain.

Accordingly, at this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the development of our product candidates.

We are also unable to predict when, if ever, we will generate revenue and material net cash inflows from the

commercialization and sale of any of our product candidates for which we may obtain marketing approval.

The successful development of our CAR-T and CAR-NK product candidates, as well as other potential future product candidates, is highly uncertain.

Accordingly, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the development of our product candidates.

We are also unable to predict

when, if ever, we will generate revenue and material net cash inflows from the commercialization and sale of any of our product candidates for which we may obtain regulatory approval.

We may never succeed in achieving regulatory approval for any of our product candidates.

6 unchanged sentences

• our ability to not infringe, misappropriate, or otherwise violate third-party intellectual property rights;

• clearance of IND applications to initiate clinical trials on product candidates;

• clearance of IND applications to initiate clinical trials on new product candidates;

• successful enrollment in, and completion of, our clinical trials on our product candidates;

2 unchanged sentences

• successful development of our internal process development and transfer to larger-scale facilities;

• establishment of agreements with CMOs for clinical and commercial supplies and scaling up manufacturing processes and capabilities to support our clinical trials;

• establishment of agreements with CMOs and suppliers for clinical and commercial supplies and scaling up manufacturing processes and capabilities to support our clinical trials;

• receipt of marketing approvals from applicable regulatory authorities;

• grant of regulatory exclusivity for our product candidates;

• establishment of sales, marketing, and distribution capabilities necessary for commercialization of our product candidates if and when approved, whether by us or in collaboration with third parties;

• establishment of sales, marketing, and distribution capabilities necessary for commercialization of our product candidates if and when approved by the applicable regulatory authorities, whether by us or in collaboration with third parties;

• maintenance of a continued acceptable safety profile of our products post-approval;

4 unchanged sentences

The following table summarizes our research and development expenses for the periods indicated:

Three Months Ended September 30, Nine Months Ended September 30,

2023 2022 2023 2022

(in thousands) (in thousands)

Three Months Ended March 31,

(in thousands)

External costs:

Expenses related to licensing, sublicensing revenue, and milestones $ 968 $ 439 $ 2,141 $ 1,301

Services provided by CROs, CMOs, clinical sites, and other third parties that conduct preclinical studies and clinical trials on our behalf 11,928 6,557 32,345 20,190

Expenses related to licenses, sublicensing revenue, and milestones

$ 3,659 $ 430

Services provided by CROs, CMOs, and other third parties that conduct preclinical studies and clinical trials on our behalf

12,096 10,279

Other research and development expenses 5,208 4,719

11 unchanged sentences

We accrue for these reimbursements as the respective expenses are incurred and classify such reimbursements as a reduction of general and administrative expenses.

During the three months ended September 30, 2023, and 2022, we recorded $0.2 million and $1.0 million, respectively, of patent cost reimbursements as a reduction to general and administrative expense.

During the nine months ended September 30, 2023, and 2022, we recorded $1.3 million and $3.1 million, respectively, of patent cost reimbursements as a reduction to general and administrative expense.

We expect that our general and administrative expenses may increase in the future as a result of expanding our operations, including hiring personnel, preparing for potential commercialization of our product candidates, and additional facility occupancy costs, as well as other expenses necessary to support the growth and operations of a clinical-stage public company.

During the three months ended March 31, 2024, and 2023, we recorded $0.1 million and $0.4 million, respectively, of patent cost reimbursements as a reduction to general and administrative expense.

We expect that our general and administrative expenses will increase in the future as a result of expanding our operations, including hiring personnel, preparing for potential commercialization of our product candidates, and additional facility occupancy costs, as well as other expenses necessary to support the growth and operations of a clinical-stage public company.

Other Income (Expense)

Other income (expense) consists primarily of interest income earned on cash and marketable securities, change in the fair value of our equity investments, and change in the fair value of the Memorial Sloan Kettering Cancer Center (“MSKCC”) success payments liability under the Exclusive License Agreement, dated November 13, 2020, with MSKCC (the “MSKCC Agreement”).

Other income (expense) consists primarily of interest income earned on cash and marketable securities and the change in fair value of the Memorial Sloan Kettering Cancer Center (“MSKCC”) success payments liability under our Exclusive License Agreement, dated November 13, 2020, with MSKCC (“MSKCC Agreement”).

Results of Operations

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

The following table summarizes our results of operations for the periods indicated:

Three Months Ended September 30,

2023 2022 Change

(in thousands)

Licensing and collaboration revenue $ 23,662 $ 3,303 $ 20,359

Operating expenses:

Research and development 28,584 19,991 8,593

General and administrative 9,711 9,849 (138)

Total operating expenses 38,295 29,840 8,455

Loss from operations (14,633) (26,537) 11,904

Other income (expense):

Change in fair value of equity securities (4) 31 (35)

Change in fair value of the MSKCC success payments liability (139) (1,607) 1,468

Other income, net 4,774 1,466 3,308

Total other income (expense) 4,631 (110) 4,741

Net loss $ (10,002) $ (26,647) $ 16,645

Licensing and Collaboration Revenue

Licensing and collaboration revenue increased by $20.4 million to $23.7 million for the three months ended September 30, 2023, from $3.3 million for the three months ended September 30, 2022.

This increase was primarily related to an increase of $19.8 million recognized under the Collaboration and License Agreement (as amended, the “AbbVie Agreement”) with AbbVie Manufacturing Management Unlimited Company (“AbbVie”), which includes the recognition of the previously deferred revenue that was recognized in full upon termination of the AbbVie Agreement.

The following table summarizes our revenue by licensee for the periods indicated:

Three Months Ended September 30,

2023 2022 Change

(in thousands)

AbbVie $ 21,476 $ 1,709 $ 19,767

Pfizer, related party

Other licensees 1,564 1,594 (30)

Total licensing and collaboration revenue

$ 23,662 $ 3,303 $ 20,359

Research and Development Expenses

Research and development expenses increased by $8.6 million to $28.6 million for the three months ended September 30, 2023, from $20.0 million for the three months ended September 30, 2022.

This increase was primarily related to increases of $5.4 million of net increase in external CMO and CRO activities for our clinical CAR-T cell therapy product candidates, driven by an increases of $3.2 million due to timing of CMO activities, and $2.2 million in CRO activities for clinical trials;

$2.5 million in personnel-related expenses, including stock-based compensation, due to headcount increases;

$1.5 million in other facilities and allocated expenses;

and $0.5 million in expenses related to licenses, sublicensing revenue, and milestones;

partially offset by a decrease of $1.3 million in other research and development expenses.

General and Administrative Expenses

General and administrative expenses decreased by $0.1 million to $9.7 million for the three months ended September 30, 2023, from $9.8 million for the three months ended September 30, 2022.

This decrease was primarily related to decreases of $1 million in patent prosecution and maintenance costs;

and $0.4 million in director and officer insurance, accounting, and other service related expenses;

partially offset by an increase of $1.1 million in personnel-related expenses, including stock-based compensation, due to headcount increases.

Total Other Income (Expense)

Total other income (expense) increased by $4.7 million for three months ended September 30, 2023, as compared to the three months ended September 30, 2022.

We recognized a loss related to the change in the fair value of the MSKCC success payments liability in the amount of $0.1 million and $1.6 million, for the three months ended September 30, 2023, and 2022, respectively.

Other income, net increased by $3.3 million during the three months ended September 30, 2023, compared to September 30, 2022.

The increase primarily relates to a $3.3 million increase in interest income earned from marketable securities.

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

Comparison of the Three Months Ended March 31, 2024, and 2023

The following table summarizes our results of operations for the periods indicated:

Nine Months Ended September 30,

Three Months Ended March 31,

2024 2023 Change

13 unchanged sentences

Licensing and Collaboration Revenue

Licensing and collaboration revenue increased by $20.8 million to $30.9 million for the nine months ended September 30, 2023, from $10.2 million for the nine months ended September 30, 2022.

This increase was primarily related to increases of $19.0 million recognized under the AbbVie Agreement with AbbVie, which includes the recognition of the previously deferred revenue that was recognized in full upon termination of the AbbVie Agreement, and $1.2 million related to the Edge Cas9 License Agreement.

Licensing and collaboration revenue decreased by $1.1 million to $2.4 million for the three months ended March 31, 2024, from $3.5 million for the three months ended March 31, 2023.

This decrease primarily relates to a decrease of $1.6 million recognized under the now-terminated Collaboration and License Agreement, dated February 9, 2021 (as amended, “AbbVie Agreement”) with AbbVie Manufacturing Management Unlimited Company (“AbbVie”), partially offset by an increase of $0.6 million in revenues recognized under our Information Rights Agreement with Pfizer, Inc.

(“Pfizer”), dated June 29, 2023.

The following table summarizes our revenue by licensee for the periods indicated:

Nine Months Ended September 30,

Three Months Ended March 31,

2024 2023 Change

1 unchanged sentence

AbbVie $ — $ 1,608 $ (1,608)

Edge Animal Health, related party 1,150 — 1,150

Pfizer, related party

3 unchanged sentences

Research and Development Expenses

Research and development expenses increased by $24.3 million to $80.8 million for the nine months ended September 30, 2023, from $56.5 million for the nine months ended September 30, 2022.

This increase was primarily related to increases of $12.2 million of net increase in external CMO and CRO activities for our clinical CAR-T cell therapy product candidates, driven by an increases of $5.3 million due to timing of CMO activities, and $6.8 million in CRO activities for clinical trials;

Research and development expenses increased by $8.1 million to $33.8 million for the three months ended March 31, 2024, from $25.7 million for the three months ended March 31, 2023.

This increase was primarily related to increases of $3.2 million in expenses related to licenses and milestones;

$2.0 million in personnel-related expenses, including stock-based compensation, due to headcount increases;

$2.6 million in other facilities and allocated expenses;

and $0.8 million in expenses related to licenses, sublicensing revenue, and milestones.

and $1.8 million of net increase in external CMO and CRO activities for our clinical CAR-T cell therapy product candidates, driven by an increase of $5.1 million in CRO activities for clinical trials, and partially offset by a decrease of $3.6 million due to timing of CMO activities.

General and Administrative Expenses

General and administrative expenses decreased by $0.7 million to $28.7 million for the nine months ended September 30, 2023, from $29.5 million for the nine months ended September 30, 2022.

This decrease was primarily related to decreases of $2.5 million in director and officer insurance, legal, accounting, and other service-related expenses;

and $0.9 million in expenses related to licenses, sublicensing revenue, and milestones partially;

offset by increases of $2 million in personnel-related expenses, including stock-based compensation, due to headcount increases;

and $0.6 million in other facilities and allocated expenses.

General and administrative expenses increased by $5.7 million to $14.6 million for the three months ended March 31, 2024, from $8.9 million for the three months ended March 31, 2023.

This increase was primarily related to increases of $4.6 million in legal, and other service-related expenses, including $3.9 million of accrued litigation settlement

and $1.3 million in personnel-related expenses, including stock-based compensation, due to headcount increases;

partially offset by a decrease of $0.4 million in patent prosecution and maintenance fees.

Total Other Income

Total other income increased by $7.7 million for nine months ended September 30, 2023, as compared to the nine months ended September 30, 2022.

We recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $0.4 million and $1.0 million, respectively, for the nine months ended September 30, 2023, and 2022, respectively.

Other income, net increased by $8.2 million during the nine months ended September 30, 2023, compared to September 30, 2022.

Total other income increased by $1.7 million for three months ended March 31, 2024, as compared to the three months ended March 31, 2023.

We recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $0.3 million, for each of the three-month periods ended March 31, 2024, and 2023.

Other income, net increased by $1.6 million during the three months ended March 31, 2024, compared to March 31, 2023.

The increase primarily relates to a $1.7 million increase in interest income earned from marketable securities.

2 unchanged sentences

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations.

We have funded our operations through sales of our capital stock, including sales of our convertible preferred stock, which generated approximately $150.1 million in aggregate net proceeds;

from our initial public offering (“IPO”) in 2021, which generated approximately $321.0 million in net proceeds;

and from an underwritten follow-on public offering in 2023, which generated approximately $134.4 million in net proceeds.

We have also received approximately $88.4 million in net proceeds from the sale of Intellia common stock.

Additionally, we received a $25.0 million equity investment from Pfizer Inc.

(“Pfizer”) through a private placement transaction in June 2023.

Further, through September 30, 2023, we received approximately $90.9 million from licensing agreements, licensing and collaboration agreements, a service agreement, patent assignments, and government grants, including $34.6 million that was received from AbbVie under the AbbVie Agreement.

On August 9, 2022, we filed a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the SEC, which allows us to, from time to time, sell up to $400.0 million of common stock, preferred stock, debt securities, warrants, rights, or units comprised of any combination thereof (including the $100.0 million of common stock reserved for our at-the-market equity offering program described below).

We have funded our operations through sales of our capital stock, including sales of our convertible preferred stock, which generated approximately $150.1 million in aggregate net proceeds through 2021, from our initial public offering (“IPO”) in 2021, which generated approximately $321.0 million in net proceeds and from an underwritten follow-on public offering in 2023, which generated approximately $134.4 million in net proceeds.

We have also received approximately $88.4 million in net proceeds from the sale of Intellia common stock through 2020.

Additionally, we received a $25.0 million equity investment from Pfizer through a private placement transaction in June 2023.

Through March 31, 2024, we received approximately $96.5 million from licensing agreements, licensing and collaboration agreements, a service agreement, patent assignments, and government grants, including $36.7 million that was received from AbbVie under the now-terminated AbbVie Agreement.

On August 9, 2022, we filed a universal shelf registration statement on Form S-3 (“Shelf Registration Statement”) with the SEC, which allows us to, from time to time, sell up to $400.0 million of common stock, preferred stock, debt securities, warrants, rights, or units comprised of any combination thereof (including the $100.0 million of common stock reserved for our at-the-market equity offering program).

The Shelf Registration Statement was declared effective by the SEC on August 16, 2022.

As of September 30, 2023, we had sold securities in an aggregate amount of $144.9 million under the Shelf Registration Statement.

On August 9, 2022, we entered into an Open Market Sale Agreement SM (the “ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which, upon the terms and subject to the conditions and limitations set forth in the ATM Sales Agreement, we may, from time to time, in our sole discretion, issue and sell, through Jefferies, acting as sales agent, up to $100.0 million of our shares of common stock, by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the “Securities Act”).

On August 9, 2022, we entered into an at-the-market Open Market Sale Agreement SM (“ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which, upon the terms and subject to the conditions and limitations set forth in the ATM Sales Agreement, we may, from time to time, in our sole discretion, issue and sell, through Jefferies, acting as sales agent, up to $100.0 million of our shares of common stock, by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act.

Jefferies uses commercially reasonable efforts consistent with its normal sales and trading practices to sell shares from time to time, based upon our instructions (including any price or size limits or other customary parameters or conditions we may impose).

We pay Jefferies a commission equal to 3.0% of the aggregate gross proceeds of any shares sold through Jefferies pursuant to the ATM Sales Agreement.

During the nine months ended September 30, 2023, we sold 168,635 shares of our common stock under the ATM Sales Agreement at an average price per share of $7.32 for aggregate gross proceeds of $1.2 million ($1.0 million net of offering expenses).

As of March 31, 2024, we have sold 1,762,806 shares of our common stock under the ATM Sales Agreement, at an average price per share of $7.32 for aggregate gross proceeds of $12.9 million ($12.3 million net of offering expenses).

In July and August 2023, we issued and sold a total of 22,115,384 shares of our common stock in an underwritten follow-on public offering at a price to the public of $6.50 per share, which included the full exercise of the underwriters’ right to purchase 2,884,615 additional shares of our common stock.

1 unchanged sentence

The shares were sold under the Shelf Registration Statement.

As of September 30, 2023, we had cash, cash equivalents, and marketable securities of $396.7 million.

As of March 31, 2024, we had cash, cash equivalents, and marketable securities of $345.9 million.

We will continue to be dependent upon equity financing, debt financing, collaboration and licensing arrangements, and/or other forms of capital raises at least until we are able to generate significant positive cash flows from our operations.

We have no current ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, except for our lease commitments as described in Note 8 to our condensed consolidated financial statements included elsewhere in this Form 10-Q, and payments under certain of our license agreements as described in Note 4 to our condensed consolidated financial statements included elsewhere in this Form 10-Q.

Based on our current operating plan, we expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months from the date of this Form 10-Q.

as described in Note 8 and in Notes 4 and 9, respectively, to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q.

Based on our current operating plan, we expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least the next 12 months from the date of this Form 10-Q.

We have based these estimates on our current assumptions, which may require future adjustments based on our ongoing business decisions.

Strategic Investment

On June 29, 2023, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with Pfizer, pursuant to which we, in a private placement transaction (the “Pfizer Investment”), agreed to issue and sell to Pfizer 4,690,431 shares of our common stock, par value $0.0001 per share, at a purchase price of $5.33 per share, for aggregate gross proceeds of approximately $25.0 million.

On June 29, 2023, we entered into a Securities Purchase Agreement with Pfizer pursuant to which we issued and sold to Pfizer 4,690,431 shares of our common stock, par value $0.0001 per share, at a purchase price of $5.33 per share, for aggregate gross proceeds of approximately $25.0 million in a private placement transaction (“Pfizer Investment”).

The issuance and sale of the shares to Pfizer closed on June 30, 2023.

We granted certain registration rights to Pfizer under the Securities Purchase Agreement covering the resale of the shares.

Unless otherwise agreed by Pfizer, we have agreed to use the proceeds from the Pfizer Investment solely in connection with (i) the development program for our allogeneic anti-BCMA CAR-T cell therapy known as CB-011 product candidate that is being evaluated in the CaMMouflage clinical trial and/or (ii) any other single-targeted anti-BCMA CAR-T cell therapy using an anti-BCMA single-chain variable fragment owned or controlled by us (collectively, cell therapies described in clauses (i) and (ii) are referred to as a “BCMA Product Candidate”), for 36 months beginning on June 29, 2023.

On June 29, 2023, in connection with the Pfizer Investment, we and Pfizer also entered into an Information Rights Agreement (the “Information Rights Agreement”), having a thirty-six (36)-month term.

Under the Information Rights Agreement, we granted Pfizer a thirty (30)-calendar day right of first negotiation (“ROFN”) if we commence or engage with any third party with respect to a potential grant of rights to develop and/or commercialize a BCMA Product Candidate, including, without limitation, a license agreement, a co-promotion/co-commercialization agreement, a profit share agreement, a joint venture agreement, or an asset sale agreement (a “Grant of Program Rights”).

If we and Pfizer do not reach an agreement with respect to a Grant of Program Rights within the 30-day period, then we may pursue

negotiations and enter into an agreement with any third party.

If we and such third party do not reach agreement on the Grant of Program Rights within a specified time period, Pfizer’s right of first negotiation would be reinstated.

Under the Information Rights Agreement, we also agreed to grant Pfizer the right to designate one representative to serve on our scientific advisory board.

Through an information sharing committee, we will provide calendar quarter updates to Pfizer regarding the development program for a BCMA Product Candidate.

Additionally, we agreed to provide Pfizer access to any preclinical or interim or final clinical data (including raw data) and results generated as part of the development program for a BCMA Product Candidate at the same time that we provide such data to a third party (other than to our service providers or the FDA or other regulatory authorities), subject to certain confidentiality exceptions.

On June 29, 2023, we and Pfizer also entered into a Voting Agreement, pursuant to which, for a period of 12 months, Pfizer agreed to cause our voting securities that Pfizer beneficially owns (within the meaning of Rules 13d-3 or 13d-5 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) in excess of 4.99% of our then issued and outstanding voting securities to be voted (i) with respect to any matter directly relating to remuneration of directors, directors’ insurance, or indemnification or release from liability of directors, in a manner proportionally consistent with the votes properly cast for and against by holders of voting securities not beneficially owned by Pfizer, and (ii) with respect to any other matter in which Pfizer shall have the right to vote such voting securities, in accordance with the recommendation of our board of directors or any applicable committee thereof.

Unless otherwise agreed by Pfizer, we have agreed to use the proceeds from the Pfizer Investment solely in connection with (i) the development program for our allogeneic anti-BCMA CAR-T cell therapy known as CB-011 product candidate that is being evaluated in our CaMMouflage clinical trial and/or (ii) any other single-targeted anti-BCMA CAR-T cell therapy using an anti-BCMA single-chain variable fragment owned or controlled by us (collectively, cell therapies described in clauses (i) and (ii) are referred to as a “BCMA Product Candidate”), for 36 months beginning on June 29, 2023.

On June 29, 2023, in connection with the Pfizer Investment, we and Pfizer also entered into an Information Rights Agreement, having a 36-month term.

Under the Information Rights Agreement, we granted Pfizer a 30 calendar day right of first negotiation (“ROFN”) if we commence or engage with any third party with respect to a potential grant of rights to develop and/or commercialize a BCMA Product Candidate, including, without limitation, a license agreement, a co-promotion/co-commercialization agreement, a profit share agreement, a joint venture agreement, or an asset sale agreement (a “Grant of Program Rights”).

If we and Pfizer do not reach an agreement with respect to a Grant of Program Rights within the 30-day period, then we may pursue negotiations and enter into an agreement with any third party.

If we and such third party do not reach agreement on the Grant of Program Rights within a specified time period, Pfizer’s right of first negotiation will be reinstated.

Under the Information Rights Agreement, we also granted Pfizer the right to designate one representative to serve on our scientific advisory board.

Through an information sharing committee, we provide calendar quarter updates to Pfizer regarding the development program for a BCMA Product Candidate.

Additionally, we provide Pfizer access to any preclinical or interim or final clinical data (including raw data) and results generated as part of the development program for a BCMA Product Candidate at the same time that we provide such data to a third party (other than to our service providers or the FDA or other regulatory authorities), subject to certain confidentiality exceptions.

On June 29, 2023, we and Pfizer also entered into a Voting Agreement, pursuant to which, for a period of 12 months, Pfizer agreed to cause our voting securities that Pfizer beneficially owns (within the meaning of Rules 13d-3 or 13d-5 under the Exchange Act) in excess of 4.99% of our then issued and outstanding voting securities to be voted (i) with respect to any matter directly relating to remuneration of directors, directors’ insurance, or indemnification or release from liability of directors, in a manner proportionally consistent with the votes properly cast for and against by holders of voting securities not beneficially owned by Pfizer, and (ii) with respect to any other matter in which Pfizer shall have the right to vote such voting securities, in accordance with the recommendation of our board of directors or any applicable committee thereof.

Funding Requirements

5 unchanged sentences

• the number and characteristics of the product candidates that we develop;

• the increase in the number of our employees and expansion of our physical facilities to support growth initiatives;

• increases in the number of our employees and expansion of our physical facilities to support growth initiatives;

• the outcome, timing, and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;

• whether we enter into any additional collaboration agreements and the terms of any such agreements;

• whether we enter into any collaboration agreements and the terms of any such agreements;

• the cost of filing and prosecuting our patent applications, and maintaining and enforcing our patents and other intellectual property rights;

4 unchanged sentences

• the cost of establishing sales, marketing, and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products without a partner;

• the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;

• the achievement of milestones or occurrence of other developments that trigger payments by or to third parties under any collaboration or licensing agreements;

• the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval;

• the achievement of milestones or occurrence of other developments that trigger payments by or to third parties;

• our implementation of various computerized informational systems and efforts to enhance operational systems;

• the impact of the COVID-19 pandemic or other public health crises or geopolitical events on our clinical development or operations;

• the impact of public health crises or geopolitical events on our clinical development or operations;

• the impact of inflationary pressures on the cost of our operations;

8 unchanged sentences

If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties or other sources, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams, or research programs or grant licenses on terms that may not be favorable to us.

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

Comparison of the Three Months Ended March 31, 2024, and 2023

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

Nine Months Ended September 30,

Three Months Ended March 31,

2024 2023 Change

1 unchanged sentence

Cash used in operating activities $ (37,203) $ (27,939) $ (9,264)

Cash used in investing activities (36,709) (94,419) 57,710

Cash provided by investing activities 22,956 20,703 2,253

Cash provided by financing activities 12,485 1,642 10,843

Net increase (decrease) in cash, cash equivalents, and restricted cash $ 45,720 $ (158,335) $ 204,055

Net decrease in cash, and cash equivalents $ (1,762) $ (5,594) $ 3,832

Cash Used in Operating Activities

Net cash used in operating activities was $71.9 million and $65.9 million for the nine months ended September 30, 2023, and 2022, respectively.

Cash used in operating activities for the nine months ended September 30, 2023, was primarily due to our net loss of $67.6 million, adjusted by non-cash charges of $8.0 million and net changes in our operating assets and liabilities of $12.3 million.

Our non-cash charges were primarily comprised of $10.2 million of stock-based compensation, $2.8 million of depreciation and amortization expense, and non-cash lease expense of $1.6 million, which were partially offset by accretion of discounts on investments of $6.0 million, and change in the fair value of the MSKCC success payments liability of $0.4 million.

The changes in our operating assets and liabilities were primarily due to an increase in accounts receivable of $0.9 million and decreases of $16.3 million in deferred revenue, current and long-term, and $0.3 million in operating lease liabilities, partially offset by decreases in prepaid expenses and other current assets of $0.9 million, contract assets of $0.6 million, and increases of $2.8 million in accrued expenses and other current liabilities, and $1.1 million in accounts payable.

Cash used in operating activities for the nine months ended September 30, 2022, was primarily due to our net loss of $72.4 million, adjusted by non-cash charges of $10.6 million and net changes in our operating assets and liabilities of

$4.1 million.

Our non-cash charges were primarily comprised of $8.6 million of stock-based compensation, non-cash lease expense of $1.6 million, $1.1 million of depreciation and amortization expense, and acquired in-process research and development of $0.3 million, which were partially offset by the change in the fair value of the MSKCC success payments liability of $1.0 million.

The changes in our operating assets and liabilities were due to increases of $1.6 million in prepaid expenses and other current assets, $0.4 million in contract assets, $0.4 million in other assets, and decreases of $2.6 million in accounts payable, $3.3 million in deferred revenue, and $0.3 million in operating lease liabilities, partially offset by decreases of $0.8 million in accounts receivable and $2.8 million in other receivables, an increase of $0.9 million in accrued expenses and other current liabilities.

Cash Used in Investing Activities

During the nine months ended September 30, 2023, cash used in investing activities was $36.7 million, and during the nine months ended September 30, 2022, cash used in investing activities was $94.4 million.

Cash used in investing activities for the nine months ended September 30, 2023, was primarily due purchases of marketable securities of $310.6 million and property and equipment of $9.3 million, partially offset by proceeds from the sales and maturities of marketable securities of $283.2 million.

Cash used in investing activities for the nine months ended September 30, 2022, was primarily due to purchases of marketable securities of $252.6 million, property and equipment of $4.7 million, and in-process research and development of $0.3 million, partially offset by the proceeds from maturities of marketable securities of $163.1 million.

Net cash used in operating activities was $37.2 million and $27.9 million for the three months ended March 31, 2024, and 2023, respectively.

Cash used in operating activities for the three months ended March 31, 2024, was primarily due to our net loss of $41.2 million, adjusted by non-cash charges of $4.9 million and net changes in our operating assets and liabilities of $0.8 million.

Our non-cash charges were primarily comprised of $4.0 million of stock-based compensation, $0.7 million of depreciation and amortization expense, and non-cash lease expense of $0.5 million, which were partially offset by change in the fair value of the MSKCC success payments liability of $0.3 million, and accretion of discounts on our marketable securities investments of $1.5 million.

The changes in our operating assets and liabilities were primarily due to an increase in accounts receivable of $0.8 million, and prepaid expenses and other current assets of $0.8 million and decreases of $2.2 million in accrued expenses and other current liabilities, and $0.7 million in deferred revenue, current and long-term, partially offset by decreases in other receivables of $0.6 million, and $0.5 million in contract assets, and an increase of $2.7 million in accounts payable.

Cash used in operating activities for the three months ended March 31, 2023, was primarily due to our net loss of $28.0 million, adjusted by non-cash charges of $2.5 million and net changes in our operating assets and liabilities of $2.4 million.

Our non-cash charges were primarily comprised of $3.1 million of stock-based compensation, $0.6 million of depreciation and amortization expense, and non-cash lease expense of $0.5 million, which were partially offset by amortization of investment premiums of $1.5 million, and change in the fair value of the MSKCC success payments liability of $0.3 million.

The changes in our operating assets and liabilities were due to increases of $1.3 million in accounts receivable, and decreases of $4.1 million in accrued expenses and other current liabilities, $1.1 million in deferred revenue, and $0.3 million in operating lease liabilities, partially offset by decreases in prepaid expenses and other current assets of $1.8 million, contract assets of $0.6 million, and other receivables of $0.5 million, and an increase of $1.5 million in accounts payable.

Cash Provided by Investing Activities

During the three months ended March 31, 2024, and 2023, cash provided by investing activities was $23.0 million, and $20.7 million, respectively.

Cash provided by investing activities for the three months ended March 31, 2024, was primarily due to proceeds from the sales and maturities of marketable securities of $97.1 million, partially offset by purchases of marketable securities of $71.2 million, in-process research and development of $1.5 million, and property and equipment of $1.4 million.

Cash provided by investing activities for the three months ended March 31, 2023, was primarily due to proceeds from the sales and maturities of marketable securities of $98.7 million, partially offset by sales of marketable securities of $75.9 million and property and equipment of $2.0 million.

Cash Provided by Financing Activities

During the nine months ended September 30, 2023, and 2022, cash provided by financing activities was $154.3 million and $2.0 million, respectively.

Cash provided by financing activities for the nine months ended September 30, 2023, was primarily due to $134.5 million of net proceeds from our follow-on public offering, $17.3 million of net proceeds allocated to the issuance of common stock in a private placement transaction with Pfizer, net proceeds from our at-the-market equity offering program of $1.0 million, and the exercise of stock options and purchases of common stock under the 2021 Employee Stock Purchase Plan (“2021 ESPP”) of $1.5 million.

Cash provided by financing activities for the nine months ended September 30, 2022, was due to the exercise of stock options and purchases of common stock under the 2021 ESPP of $2.0 million.

During the three months ended March 31, 2024, and 2023, cash provided by financing activities was $12.5 million and $1.6 million, respectively.

Cash provided by financing activities for the three months ended March 31, 2024, was primarily due to net proceeds from our at-the-market equity offering program of $11.3 million, the purchases of common stock under the 2021 Employee Stock Purchase Plan (“2021 ESPP”) of $0.7 million, and the exercise of stock options of $0.5 million.

Cash provided by financing activities for the three months ended March 31, 2023, was due to net proceeds from our at-the-market equity offering program of $1.1 million and the exercise of stock options and purchases of common stock under the 2021 ESPP of $0.5 million.

Critical Accounting Policies and Significant Judgments and Estimates

4 unchanged sentences

See Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for more information regarding recently issued accounting pronouncements.

Indemnification Agreements

As permitted under Delaware General Corporation Law and in accordance with our amended and restated bylaws, we indemnify our executive officers and directors for certain events or occurrences while such officer or director is or was serving in such capacity.

We are also party to indemnification agreements with our executive officers, directors, and controller.

We believe the fair value of the indemnification rights and agreements is minimal.

Accordingly, we have not recorded any liabilities for these indemnification rights and agreements as of September 30, 2023.

Emerging Growth Company and Smaller Reporting Company Status

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”).

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”).

Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.

elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

As a result, our condensed consolidated financial statements may not be comparable to those of companies that comply with the new or revised accounting pronouncements as of public company effective dates.

We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (a) are no longer an emerging growth company or (b) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

As a result, our unaudited condensed consolidated financial statements may not be comparable to those of companies that comply with the new or revised accounting pronouncements as of public company effective dates.

We expect to use the extended transition period for any other new or revised accounting standards during the period in which we remain an emerging growth company.

2 unchanged sentences

Quantitative and Qualitative Disclosures about Market Risk.

There have been no material changes to our market risk during the nine months ended September 30, 2023.

There have been no material changes to our market risk during the three months ended March 31, 2024.

For a discussion of our exposure to market risk, refer to the section titled “Quantitative and Qualitative Disclosures About Market Risk” in our Form 10-K.

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