Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: 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, 2025 (“Form 10-Q”) and with the audited consolidated financial statements and the related notes for the fiscal year ended December 31, 2024 included in our Annual Report on Form 10-K (“Form 10-K”) filed with the U.S.
+Added: 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 June 30, 2025 (“Form 10-Q”) and with the audited consolidated financial statements and the related notes for the fiscal year ended December 31, 2024, included in our Annual Report on Form 10-K (“Form 10-K”) filed with the U.S.
Securities and Exchange Commission (“SEC”) on March 10, 2025.
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A retrospective analysis of all patient data demonstrated that patients who received a dose of CB-010 manufactured from a donor with at least four matching human leukocyte antigen (“HLA”) alleles (of 12 total alleles) with the patient (referred to as “partial HLA matching”) resulted in improved progression-free survival (“PFS”) compared to patients who received a single dose of CB-010 from a donor with fewer than four matching HLA alleles.
−Removed: To confirm the partial HLA matching strategy, we are enrolling approximately 20 additional 2L LBCL patients in the ongoing ANTLER phase 1 clinical trial.
+Added: To confirm the partial HLA matching strategy, we have completed enrollment of approximately 20 additional 2L LBCL patients in the ongoing ANTLER phase 1 clinical trial.
In addition, we are enrolling a proof-of-concept cohort of up to 10 patients in our ANTLER phase 1 clinical trial who have relapsed following any prior CD19-targeted therapy in this population of unmet need.
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This reduces the number of potential mismatched HLA alleles to six from 12, resulting in a reduced risk of rapid immunologic clearing of the CAR-T cells by the patient.
−Removed: In the dose escalation portion of our CaMMouflage phase 1 clinical trial, dose level 1 (50x10 6 viable CAR-T cells), dose level 2 (150x10 6 viable CAR-T cells), dose level 3 (450x10 6 viable CAR-T cells), and dose level 4 (800x10 6 viable CAR-T cells) of CB-011 have cleared without any observed dose-limiting toxicities (“DLTs”).
−Removed: We have implemented a deeper lymphodepletion regimen that includes an increased dose of cyclophosphamide (up from the original 300 mg/m 2/ day to 500 mg/m 2 /day together with the same fludarabine dose of 30 mg/m 2 /day for three days).
−Removed: Dose level 2 (150x10 6 viable CAR-T cells), dose level 3 (450x10 6 viable CAR-T cells), and dose level 4 (800x10 6 viable CAR-T cells) with the deeper lymphodepletion have cleared with no DLTs observed.
−Removed: We are enrolling additional patients with the deeper lymphodepletion regimen in order to further define safety and efficacy and to determine the recommended doses for expansion.
−Removed: On April 24, 2025, we announced a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on our CB-010 and CB-011 oncology programs.
+Added: In the dose escalation portion of our CaMMouflage phase 1 clinical trial, we implemented a deeper lymphodepletion regimen that includes an increased dose of cyclophosphamide (up from the original 300 mg/m 2 /day to 500 mg/m 2 /day together with the same fludarabine dose of 30 mg/m 2 /day for three days).
+Added: We have completed planned enrollment of additional patients with this lymphodepletion regimen across multiple dose levels (150x10 6 viable CAR-T cells, 300x10 6 viable CAR-T cells, 450x10 6 viable CAR-T cells, and 800x10 6 viable CAR-T cells) in order to further define safety and efficacy and to determine the recommended dose(s) for expansion.
+Added: No dose-limiting toxicities have been observed at any dose level.
+Added: On April 24, 2025, we announced a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on our CB-010 and CB-011 product candidates.
At that time, we disclosed that we had discontinued our GALLOP phase 1 trial of CB-010 for the treatment of lupus prior to dosing the first patient;
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Patients treated in the AMpLify phase 1 clinical trial will continue to be followed as part of our long-term follow up study.
−Removed: Additionally, we announced that our workforce was reduced by 47 employees, or approximately 32% of our company.
−Removed: In connection with the strategic pipeline prioritization and the workforce reduction, we currently estimate that expenses of approximately $2.5 million to $3.5 million in total will be incurred, consisting primarily of cash severance costs, benefits, and transition support services for impacted employees and costs to wind down our GALLOP phase 1 clinical trial and our AMpLify phase 1 clinical trial.
−Removed: The charges that we expect to incur in connection with the foregoing are subject to a number of assumptions, and actual results may differ materially.
−Removed: We may also incur costs not currently contemplated due to events that may occur as a result of, or that are associated with, our strategic pipeline prioritization with workforce and cost reduction initiatives.
+Added: Additionally, we announced that our workforce was reduced by 47 employees, or approximately 32% of our workforce.
+Added: As a result, we recorded cash severance costs, benefits, and transition support services expenses of $1.8 million for each of the three- and six-month periods ended June 30, 2025, which we recorded as research and development expenses or general and administrative expenses in our unaudited condensed consolidated statements of operations and comprehensive loss.
+Added: For each of the three- and six-month periods ended June 30, 2025, we recorded wind down costs of $0.3 million as research and development expenses in our unaudited condensed consolidated statements of operations and comprehensive loss related to the discontinuation of our GALLOP phase 1 clinical trial and AMpLify phase 1 clinical trial.
+Added: In connection with the discontinuation of the AMpLify phase 1 clinical trial for our CB-012 product candidate, we provided notice of termination on May 13, 2025, to Memorial Sloan Kettering Cancer Center (“MSKCC”) of our Exclusive License Agreement, dated November 13, 2020, with MSKCC (as amended, “MSKCC Agreement”), which termination was effective on August 11, 2025.
+Added: Under the MSKCC Agreement, we had exclusively licensed from MSKCC know-how, biological materials, and related patent families to the single-chain variable fragment (“scFv”) used in our CB-012 product candidate.
+Added: In conjunction with the previously announced strategic pipeline prioritization, we have reduced the usage of our leased office and lab space, and we may sublease the unused space.
+Added: Accordingly, in connection with the preparation of the financial statements for the three and six months ended June 30, 2025, we evaluated the related leasehold improvements, right of use assets, and lab equipment and concluded that this asset group is impaired.
+Added: As a result, we recognized impairment charges totaling $10.0 million for each of the three- and six-month periods ended June 30, 2025, of which $7.4 million and $2.6 million, respectively, were related to the tenant improvements and right of use asset associated with the underlying leased property.
+Added: We also identified certain laboratory equipment that we no longer intend to use.
+Added: As a result, this equipment was deemed impaired, resulting in a $2.2 million impairment charge for each of the three- and six-month periods ended June 30, 2025.
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.
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(“Intellia”) common stock.
−Removed: Our net losses for the three months ended March 31, 2025, and March 31, 2024, were $40.0 million and $41.2 million, respectively.
−Removed: We had an accumulated deficit of $488.4 million as of March 31, 2025.
+Added: Our net losses for the three months ended June 30, 2025, and June 30, 2024, were $54.1 million and $37.7 million, respectively.
+Added: Our net losses for the six months ended June 30, 2025, and June 30, 2024, were $94.1 million and $78.9 million, respectively.
+Added: We had an accumulated deficit of $542.5 million as of June 30, 2025.
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.
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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.
+Added: Our common stock is currently listed for trading on the Nasdaq Global Select Market under the symbol “CRBU.” The continued listing of our common stock on Nasdaq is subject to our compliance with a number of listing standards.
+Added: On May 7, 2025, we received a letter from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC notifying us that, for the prior 30 consecutive business days, the bid price for our shares of common stock had closed below $1.00 per share, which is the minimum bid price required to maintain continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1) (“Minimum Bid Price Rule”).
+Added: On June 18, 2025, we received a written notice (“Compliance Notice”) from the Staff notifying us that, from June 3, 2025, to June 17, 2025, the closing bid price of our common stock had been $1.00 per share or greater and, accordingly, we had regained compliance with the Minimum Bid Price Rule.
Components of Results of Operations
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Each of these payments results in licensing and collaboration revenue.
−Removed: Revenue under such licensing and collaboration agreements was $2.4 million for each of the three-month periods ended March 31, 2025, and March 31, 2024.
+Added: Revenue under such licensing and collaboration agreements was $2.7 million and $3.5 million for the three months ended June 30, 2025, and June 30, 2024, respectively, and $5.0 million and $5.9 million for the six months ended June 30, 2025, and June 30, 2024, respectively.
See Notes 5 and 7 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
−Removed: 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.
For the foreseeable future, we expect substantially all our revenue will be generated from licensing and collaboration agreements.
+Added: See Note 2 to the consolidated financial statements included in our Form 10-K for additional information about our revenue recognition policy related to our licensing and collaboration agreements.
Operating Expenses
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• costs incurred in connection with the clinical development and manufacturing of our product candidates, including under agreements with CMOs, suppliers, clinical research organizations (“CROs”), and clinical sites;
−Removed: • other research and development costs and consulting services.
+Added: • other research and development costs, including lab supplies, and consulting services.
Internal costs include:
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Costs of certain activities are recognized based on an evaluation of the progress to completion of specific tasks.
−Removed: 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 unaudited condensed consolidated balance sheets.
+Added: 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 in our unaudited condensed consolidated balance sheets.
The capitalized amounts are recognized as expenses as the goods are delivered or as related services are performed.
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The following table summarizes our research and development expenses for the periods indicated:
−Removed: Three Months Ended March 31,
−Removed: (in thousands)
+Added: Three Months Ended June 30, Six Months Ended June 30,
+Added: 2025 2024 2025 2024
+Added: (in thousands) (in thousands)
External costs:
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We expect that our general and administrative expenses will increase in the future if our clinical trials are successful and if we prepare for potential commercialization of our product candidates, as expenses would increase to support the growth and operations of a public company with late-stage clinical programs and potential commercial products.
−Removed: Other income 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 (as amended, “MSKCC Agreement”).
+Added: Impairment Charges
+Added: Impairment charges consist of charges related to the strategic pipeline prioritization with workforce and cost reduction initiatives announced on April 24, 2025, and include impairment of our leasehold improvements, right of use assets, and lab equipment.
+Added: See Note 13 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
+Added: Other Income (Expense)
+Added: Other income (expense) consists primarily of impairment of an equity investment, interest income earned on cash and marketable securities and the change in fair value of the MSKCC success payments liability under our MSKCC Agreement.
Results of Operations
−Removed: Comparison of the Three Months Ended March 31, 2025, and March 31, 2024
+Added: Comparison of the Three Months Ended June 30, 2025, and June 30, 2024
The following table summarizes our results of operations for the periods indicated:
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
2025 2024 Change
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General and administrative 10,403 11,485 (1,082)
+Added: Impairment charges 12,150 — 12,150
Total operating expenses 50,245 46,965 3,280
Loss from operations (47,578) (43,501) (4,077)
−Removed: Other income:
+Added: Other income (expense):
+Added: Impairment of equity investment (9,158) — (9,158)
Change in fair value of the MSKCC success payments liability 451 1,795 (1,344)
Other income, net 2,187 4,009 (1,822)
−Removed: Total other income 2,922 4,768 (1,846)
+Added: Total other income (expense) (6,520) 5,804 (12,324)
Net loss $ (54,098) $ (37,697) $ (16,401)
Licensing and Collaboration Revenue
−Removed: Licensing and collaboration revenue decreased by less than $0.1 million to $2.4 million for the three months ended March 31, 2025, from $2.4 million for the three months ended March 31, 2024.
+Added: Licensing and collaboration revenue decreased by $0.8 million to $2.7 million for the three months ended June 30, 2025, from $3.5 million for the three months ended June 30, 2024.
+Added: This decrease primarily relates to a $1.6 million decrease related to the Exclusive License Agreement for Veterinary Therapeutics (as amended, the “Edge chRDNA License Agreement”) with Edge Animal Health (“Edge”) reflecting the issuance of additional shares of convertible preferred stock by Edge to us in the three months ended June 30, 2024, which was partially offset by a $0.8 million increase related to other licensees.
The following table summarizes our revenue by licensee for the periods indicated:
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
2025 2024 Change
(in thousands)
+Added: Edge Animal Health, related party $ — $ 1,623 $ (1,623)
Pfizer, related party
+Added: Other licensees 2,045 1,219 826
+Added: Total licensing and collaboration revenue $ 2,667 $ 3,464 $ (797)
+Added: Research and Development Expenses
+Added: Research and development expenses decreased by $7.8 million to $27.7 million for the three months ended June 30, 2025, from $35.5 million for the three months ended June 30, 2024.
+Added: This decrease was primarily related to decreases of (i) $4.6 million in other research and development e xpenses primarily related to the reduction in workforce and strategic pipeline prioritization, (ii) $2.0 million in external CM O and CRO activities for our clinical CAR-T cell therapy product candidates, driven by decreases of (a) $1.4 million due to timing of CMO activities and (b) $0.6 million in CRO activities for clinical trials, (iii) $1.0 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, and (iv) $0.3 million in other facilities and allocated expenses.
+Added: General and Administrative Expenses
+Added: General and administrative expenses decreased by $1.1 million to $10.4 million for the three months ended June 30, 2025, from $11.5 million for the three months ended June 30, 2024.
+Added: This decrease was primarily related to (i) a decrease of $0.9 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, (ii) a decrease of $0.3 million in patent prosecution and maintenance costs, (iii) a decrease of $0.3 million in legal, and other service related expenses;
+Added: partially offset by an increase of $0.4 million in other facilities and allocated expenses.
+Added: Impairment Charges
+Added: In conjunction with the previously announced strategic pipeline prioritization, impairment charges were $12.2 million for the three months ended June 30, 2025, compared to zero for the three months ended June 30, 2024.
+Added: These charges include $7.4 million related to tenant improvements, $2.6 million for the right-of-use asset, and $2.2 million for lab equipment.
+Added: Total Other Income (Expense)
+Added: Total other income (expense) decreased by $12.3 million for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.
+Added: Impairment of equity investment was $9.2 million related to our equity investment in Edge for the three months ended June 30, 2025, compared to zero for the three months ended June 30, 2024.
+Added: See Note 3 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
+Added: In connection with our termination of the MSKCC Agreement, we recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $0.5 million for the three months ended June 30, 2025.
+Added: We recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $1.8 million for the three months ended June 30, 2024.
+Added: Other income, net decreased by $1.8 million for the three months ended June 30, 2025, compared to June 30, 2024.
+Added: This decrease was primarily related to a $1.9 million decrease in interest income earned from marketable securities.
+Added: Comparison of the Six Months Ended June 30, 2025, and June 30, 2024
+Added: The following table summarizes our results of operations for the periods indicated:
+Added: Six Months Ended June 30,
+Added: 2025 2024 Change
+Added: (in thousands)
+Added: Licensing and collaboration revenue $ 5,020 $ 5,893 $ (873)
+Added: Operating expenses:
+Added: Research and development 63,223 69,268 (6,045)
+Added: General and administrative 20,138 26,128 (5,990)
+Added: Impairment charges 12,150 — 12,150
+Added: Total operating expenses 95,511 95,396 (12,035)
+Added: Loss from operations (90,491) (89,503) 11,162
+Added: Other income (expense):
+Added: Impairment of equity investment (9,158) — (9,158)
+Added: Change in fair value of the MSKCC success payments liability 785 2,098 (1,313)
+Added: Other income, net 4,775 8,474 (3,699)
+Added: Total other income (expense) (3,598) 10,572 (5,012)
+Added: Net loss $ (94,089) $ (78,931) $ 6,150
+Added: Licensing and Collaboration Revenue
+Added: Licensing and collaboration revenue decreased by $0.9 million to $5.0 million for the six months ended June 30, 2025, from $5.9 million for the six months ended June 30, 2024.
+Added: This decrease primarily relates to a $1.6 million decrease related to the Edge chRDNA License Agreement reflecting the issuance of additional shares of convertible preferred stock by Edge to us in the six months ended June 30, 2024, which was partially offset by a $0.8 million increase related to other licensees.
+Added: The following table summarizes our revenue by licensee for the periods indicated:
+Added: Six Months Ended June 30,
+Added: 2025 2024 Change
+Added: (in thousands)
+Added: Edge Animal Health, related party
$ — $ 1,623 $ (1,623)
+Added: Pfizer, related party
+Added: 1,243 1,243 —
Other licensees 3,777 3,027 750
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Research and Development Expenses
−Removed: Research and development expenses increased by $1.7 million to $35.5 million for the three months ended March 31, 2025, from $33.8 million for the three months ended March 31, 2024.
−Removed: This increase was primarily related to (i) an increase of $3.9 million in external CMO and CRO activities for our clinical CAR-T cell therapy product candidates, driven by (a) an increase of $2.0 million in CRO activities for clinical trials and (b) an increase of $1.9 million due to timing of CMO activities;
−Removed: (ii) an increase of $0.5 million in other facilities and allocated expenses;
−Removed: (iii) an increase of $0.3 million in personnel-related expenses, including an increase in salary and benefit expense of $0.2 million and an increase in stock-based compensation of $0.1 million;
−Removed: partially offset by decreases of $2.5 million in expenses related to licenses, sublicensing revenue, and milestones and $0.5 million in other research and development expenses to advance preclinical and clinical research for our programs, as well as other consulting services related.
+Added: Research and development expenses decreased by $6.0 million to $63.2 million for the six months ended June 30, 2025, from $69.3 million for the six months ended June 30, 2024.
+Added: This decrease was primarily related to (i) a decrease of $5.1 million in other research and development expenses primarily related to the reduction in workforce and strategic pipeline prioritization , (ii) a decrease of $2.5 million in expenses related to licenses, sublicensing revenue, and milestones, (iii) a decrease of $0.6 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization;
+Added: partially offset by an increase of $1.9 million in external CMO and CRO activities, driven by increases of (a) $1.4 million in CRO activities for clinical trials, and (b) $0.5 million due to timing of CMO activities, and an increase of $0.3 million in other facilities and allocated expenses.
General and Administrative Expenses
−Removed: General and administrative expenses decreased by $4.9 million to $9.7 million for the three months ended March 31, 2025, from $14.6 million for the three months ended March 31, 2024.
−Removed: This decrease was primarily related to decreases of $4.5 million in legal expenses, including $3.9 million related to the accrual of a securities class action litigation settlement expense in 2024, other service-related expenses, and $0.3 million in personnel-related expenses, including a decrease in stock-based compensation of $0.2 million and a decrease of $0.1 million in salary and benefit expenses.
−Removed: Total Other Income
−Removed: Total other income decreased by $1.8 million for the three months ended March 31, 2025, as compared to the three months ended March 31, 2024.
−Removed: 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, 2025, and March 31, 2024.
−Removed: Other income, net decreased by $1.9 million during the three months ended March 31, 2025, compared to March 31, 2024.
+Added: General and administrative expenses decreased by $6.0 million to $20.1 million for the six months ended June 30, 2025, from $26.1 million for the six months ended June 30, 2024.
+Added: This decrease was primarily related to (i) a decrease of $4.7 million in legal expenses, including $3.9 million related to the accrual of a securities class action litigation settlement expense in 2024, (ii) a decrease of $1.3 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, (iii) a decrease of $0.3 million in patent prosecution and maintenance costs;
+Added: partially offset by an increase of $0.3 million in facilities and allocated expenses.
+Added: Impairment Charges
+Added: In conjunction with the previously announced strategic pipeline prioritization, impairment charges were $12.2 million for the six months ended June 30, 2025, compared to zero for the six months ended June 30, 2024.
+Added: These charges include $7.4 million related to tenant improvements, $2.6 million for the right-of-use asset, and $2.2 million for lab equipment.
+Added: Total Other Income (Expense)
+Added: Total other income decreased by $5.0 million for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.
+Added: Impairment of equity investment was $9.2 million related to our equity investment in Edge for the six months ended June 30, 2025, compared to zero for the six months ended June 30, 2024.
+Added: See Note 3 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
+Added: In connection with our termination of the MSKCC Agreement, we recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $0.8 million for the six months ended June 30, 2025.
+Added: We recognized a gain related to the change in the fair value of the MSKCC success payments liability in the amount of $2.1 million for the six months ended June 30, 2024.
+Added: Other income, net decreased by $3.7 million for the six months ended June 30, 2025, compared to June 30, 2024.
This decrease was primarily related to a $3.8 million decrease in interest income earned from marketable securities.
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Sources of Liquidity
−Removed: Since our inception through March 31, 2025, we have raised an aggregate net proceeds of $838.1 million to fund our operations through our initial public offering (“IPO”);
+Added: Since our inception through June 30, 2025, we have raised an aggregate net proceeds of $840.0 million to fund our operations through our initial public offering (“IPO”);
sales of convertible preferred stock;
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and government grants.
−Removed: As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $212.5 million.
−Removed: Shelf Registration Statement
−Removed: 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 described below).
−Removed: The Shelf Registration Statement was declared effective by the SEC on August 16, 2022, and will expire after three years on August 16, 2025.
−Removed: As of March 31, 2025, $239.4 million remained available and unallocated under the Shelf Registration Statement, including $83.1 million for our at-the-market equity offering program.
−Removed: We plan to file a replacement shelf registration statement prior to expiration of the Shelf Registration Statement.
+Added: As of June 30, 2025, we had cash, cash equivalents, and marketable securities of $183.9 million.
+Added: Shelf Registration Statements
+Added: On August 9, 2022, we filed a universal shelf registration statement on Form S-3 (“2022 Shelf Registration Statement”) with the SEC, which allowed us to sell, from time to time, 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 under the 2022 Shelf Registration Statement for our at-the-market equity offering program described below).
+Added: The 2022 Shelf Registration Statement was declared effective by the SEC on August 16, 2022, and was scheduled to expire after three years from the date of effectiveness.
+Added: On May 8, 2025, in anticipation of the expiration of the 2022 Shelf Registration Statement, we filed a new shelf registration statement on Form S-3 (“2025 Shelf Registration Statement”).
+Added: Pursuant to the 2025 Shelf Registration Statement, we may, from time to time, sell up to $300.0 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 under the 2025 Shelf Registration Statement for our at-the-market equity offering program described below).
+Added: The 2025 Shelf Registration Statement was declared effective by the SEC on May 14, 2025, and will expire after three years from the date of effectiveness.
+Added: Upon effectiveness of the 2025 Shelf Registration Statement, the offering of securities under the 2022 Shelf Registration Statement was deemed terminated.
At-the-Market Equity Offering Program
−Removed: On August 9, 2022, we entered into an 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 under the Shelf Registration Statement, 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.
−Removed: 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).
−Removed: We plan to include a new “at the market” facility in the replacement shelf registration statement, with Jefferies acting as sales agent pursuant to the ATM Sales Agreement, prior to expiration of the Shelf Registration Statement.
−Removed: Through March 31, 2025, we sold an aggregate of 3,588,696 shares of our common stock under the ATM Sales Agreement at an average price per share of $4.71 for aggregate gross proceeds of $16.9 million ($16.2 million net of offering expenses).
−Removed: During the three months ended March 31, 2025, we did not sell any shares of our common stock under the ATM Sales Agreement.
+Added: On August 9, 2022, we entered into an 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, from time to time, we could have issued and sold, through Jefferies, acting as sales agent, up to $100.0 million of our shares of common stock under the 2022 Shelf Registration Statement.
+Added: Through May 14, 2025, we issued and sold an aggregate of 3,588,696 shares of our common stock under the ATM Sales Agreement and the 2022 Shelf Registration Statement at an average price per share of $4.71 for aggregate gross proceeds of $16.9 million ($16.2 million net of offering expenses).
+Added: During each of the three- and six-month periods ended June 30, 2025, we did not sell any shares of our common stock under the 2022 ATM Sales Agreement.
+Added: With the effectiveness of the 2025 Shelf Registration Statement, we refreshed our at-the-market program under the ATM Sales Agreement.
+Added: We may, from time to time, sell and issue shares of our common stock, through Jefferies as sales agent under the ATM Sales Agreement, having an aggregate offering price of up to $100.0 million in gross proceeds under the 2025 Shelf Registration Statement, 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.
+Added: Jefferies has agreed to use 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).
+Added: During each of the three- and six-month periods ended June 30, 2025, we did not sell any shares of our common stock pursuant to the ATM Sales Agreement under either the 2022 Shelf Registration Statement or the 2025 Shelf Registration Statement.
Funding Requirements
29 unchanged sentences
If we are unable to raise capital as and when needed or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.
−Removed: Strategic Investment
−Removed: On June 29, 2023, we entered into a Securities Purchase Agreement (“Securities Purchase Agreement”) with Pfizer, Inc.
−Removed: (“Pfizer”) pursuant to which we, in a private placement transaction, agreed to issue and sell to Pfizer 4,690,431 shares of our common stock at a purchase price of $5.33 per share, for aggregate gross proceeds of approximately $25.0 million (“Pfizer Investment”).
−Removed: The issuance and sale of the shares to Pfizer closed on June 30, 2023.
−Removed: We granted certain registration rights to Pfizer under the Securities Purchase Agreement covering the resale of the shares.
−Removed: 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 product candidate (CB-011) that is being evaluated in our CaMMouflage phase 1 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.
−Removed: 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.
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: Under the Information Rights Agreement, we also granted Pfizer the right to designate one representative to serve on our scientific advisory board (“SAB”).
−Removed: Through an information sharing committee, we provide calendar quarter updates to Pfizer regarding the development program for a BCMA Product Candidate.
−Removed: 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.
−Removed: Comparison of the Three Months Ended March 31, 2025, and March 31, 2024
+Added: Comparison of the Six Months Ended June 30, 2025, and June 30, 2024
The following table summarizes our cash flows for the periods indicated:
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
2025 2024 Change
5 unchanged sentences
Cash Used in Operating Activities
−Removed: Net cash used in operating activities was $36.7 million for the three months ended March 31, 2025, compared to $37.2 million for the three months ended March 31, 2024.
−Removed: This decrease was primarily driven by decreases in net loss;
−Removed: accretion of discounts on investments in marketable securities, net;
−Removed: and an increase in net changes in prepaid expenses and other current assets;
−Removed: partially offset by decreases in acquired in-process research and development and in net changes of accounts payable.
+Added: Net cash used in operating activities was $65.0 million for the six months ended June 30, 2025, compared to $70.1 million for the six months ended June 30, 2024.
+Added: This decrease was due to (i) changes in the components of net loss primarily related to (a) an increase in non-cash charges primarily for impairment charges and impairment of equity investment incurred for the six months ended June 30, 2025, and (b) decreases in research and development expenses and general and administrative expenses;
+Added: and (ii) a decrease in net changes in our operating assets and liabilities primarily related to a decrease in net changes of accrued expenses and other current liabilities;
+Added: partially offset by an increase in net changes in other assets.
Cash Provided by Investing Activities
−Removed: Net cash provided by investing activities was $49.4 million for the three months ended March 31, 2025, compared to $23.0 million for the three months ended March 31, 2024.
+Added: Net cash provided by investing activities was $73.4 million for the six months ended June 30, 2025, compared to $44.2 million for the six months ended June 30, 2024.
The increase in net cash provided by investing activities was primarily driven by lower cash utilized for purchases of marketable securities;
1 unchanged sentence
Cash Provided by Financing Activities
−Removed: Net cash provided by financing activities was $0.5 million for the three months ended March 31, 2025, compared $12.5 million for the three months ended March 31, 2024.
−Removed: The decrease was primarily driven by proceeds from the issuance of common stock under the ATM Sales Agreement, net of offering expenses, during the three months ended March 31, 2024.
−Removed: We did not sell any common stock under the ATM Sales Agreement during the three months ended March 31, 2025.
+Added: Net cash provided by financing activities was $0.5 million for the six months ended June 30, 2025, compared to $12.6 million for the six months ended June 30, 2024.
+Added: The decrease was primarily driven by proceeds from the issuance of common stock under the ATM Sales Agreement, net of offering expenses, for the six months ended June 30, 2024.
+Added: We did not sell any common stock pursuant to the ATM Sales Agreement during the six months ended June 30, 2025, under either the 2022 Shelf Registration Statement or the 2025 Shelf Registration Statement.
Critical Accounting Policies and Significant Judgments and Estimates
1 unchanged sentence
Since the date of such financial statements, there have been no material changes to our significant accounting policies.
−Removed: There have been no material changes to our critical accounting estimates as compared to those disclosed in our Form 10-K.
+Added: Other than the estimates noted below, there have been no material changes to our critical accounting estimates as compared to those disclosed in our Form 10-K.
+Added: Impairment of Long-Lived Assets
+Added: We review long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable.
+Added: In order to determine if assets have been impaired, assets are grouped and tested at the lowest level for which identifiable independent cash flows are available.
+Added: An impairment loss is recognized when the sum of projected undiscounted cash flows is less than the carrying value of the asset group.
+Added: The measurement of the impairment loss to be recognized is based on the difference between the fair value and the carrying value of the asset group.
+Added: Fair value may be determined using a market approach or income approach.
Recently Issued Accounting Pronouncements
−Removed: 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.
+Added: See Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Quantitative and Qualitative Disclosures about Market Risk.
−Removed: There have been no material changes to our market risk during the three months ended March 31, 2025.
+Added: There have been no material changes to our market risk during the six months ended June 30, 2025.
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.