What changed in this filing

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Item 1. Business

2026-03-27 compared with 2025-03-20 · 115 added, 141 removed, 688 unchanged (27% of the section changed)

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Our lead product candidates utilize off-the-shelf healthy adult donor derived natural killer (“NK”) cells to create CAR-NK cells outfitted with gene circuit technologies in several oncology indications with high unmet need.

In 2024, we initiated a clinical trial of SENTI-202 for blood cancers and our partner, Celest Therapeutics, initiated a clinical trial for SN301A for solid tumors.

Our lead product candidate, SENTI-202, is a potentially first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for the treatment of blood cancers currently being studied in an open-label, multi-center Phase 1 clinical trial in the United States and Australia for the treatment of relapsed/refractory hematological malignancies, including Acute Myeloid Leukemia (“AML”).

The second product candidate SN301A, is a multi-armed, off-the-shelf CAR-NK cell therapy for the treatment of solid tumors currently being studied in an investigator-initiated open-label single-center study for the treatment of hepatocellular carcinoma (“HCC”) in mainland China, in collaboration with Celest Therapeutics.

SN301A utilizes the SENTI-301A gene circuit developed by Senti and refers to the CAR-NK product candidate manufactured by Celest Therapeutics in China.

Our pipeline also includes additional preclinical programs:

(i) a solid tumor cell therapy program, (ii) our partnered programs related to gene therapies for tissue-directed targets with Spark Therapeutics, Inc.

(“Spark Therapeutics”) and (iii) our partnered programs related to cell

therapies for regenerative medicines with BlueRock Therapeutics, Inc.

(i) a solid tumor cell therapy program, (ii) our partnered programs related to cell therapies for regenerative medicines with BlueRock Therapeutics, Inc.

(“BlueRock Therapeutics”).

Our most advanced programs, SENTI-202 and SENTI-301A, originate from our internal pipeline of programs.

Our most advanced program, SENTI-202, originates from our internal pipeline of programs.

Our goal is to maintain and build upon our leadership position in the cell and gene therapy landscape utilizing our proprietary gene circuit technology and synthetic biology expertise.

We are pursuing this goal by leveraging our unique approach to programming gene circuits, which we believe may be broadly applicable toward engineering optimal efficacy, precision and control into cell or gene-based medicines, rapidly advancing our pipeline of cell therapies for oncology indications and establishing strategic collaborations/partnerships to support our non-oncology programs and manufacturing.

therapies for oncology indications and establishing strategic collaborations/partnerships to support our non-oncology programs and manufacturing.

We plan to develop and, if approved, commercialize cell therapy products for the treatment of cancer.

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• Advance internal pipeline of CAR-NK cell therapies for blood cancer indications through the clinical development of our lead product candidate, SENTI-202;

▪ Advance the clinical development of the SN301A program for solid tumor indications through our strategic partnership with Celest Therapeutics;

• Advance the development of additional solid tumor cell therapy programs utilizing the gene circuit technologies and strategies similar to those in our clinical stage programs SENTI-202 and/or SN301A;

• Leverage partnering to support indications beyond oncology, including our ongoing partnerships with Spark Therapeutics to develop gene therapies for tissue-directed targets, and with BlueRock Therapeutics to develop cell therapies for regenerative medicines;

• Advance the development of additional solid tumor cell therapy programs utilizing the gene circuit technologies and strategies similar to those in our clinical stage program SENTI-202;

• Leverage partnering to support indications beyond oncology, including our ongoing partnership with BlueRock Therapeutics to develop cell therapies for regenerative medicines;

• Establish additional value-creating collaborations to access the full potential of our technology in additional modalities including T cells, tumor infiltrating lymphocytes (“TILs”), stem cells including induced Pluripotent Stem Cells (“iPSCs”) and Hematopoietic Stem Cells (“HSCs”), in vivo gene therapy such as adeno associated virus (“AAV”), and messenger ribonucleic acid (“mRNA”).

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SENTI-202 is currently being studied in an open-label Phase 1 clinical trial in the United States and Australia for the treatment of relapsed/refractory hematologic malignancies, including AML.

We reported initial clinical data for this trial on December 2, 2024, which included three AML patients treated at the lowest dose level approved in our Phase 1 clinical trial protocol (the “Initial 3 AML Patients”).

The initial clinical data showed that two of the first three AML patients treated achieved complete remission, and both patients in complete remission were also assessed as measurable residual disease (“MRD”) negative after treatment.

Both of the responding Initial 3 AML Patients continue in remission as of the date of the filing of this Annual Report on Form 10-K.

In addition to the Initial AML Patients, we have enrolled and dosed other AML patients in our SENTI-202 clinical trial and have seen similar efficacy and safety results in the additional patients.

We anticipate releasing additional data on the SENTI-202 clinical trial at the 2025 AACR Annual Meeting to be held in April 2025.

We reported clinical data for this trial in 2024 and 2025, which included twenty AML patients treated in our Phase 1 clinical trial protocol (the “Phase 1 Patients”).

The initial clinical data showed that of the Phase 1 Patients, there was a 50% overall response rate during our Phase 1 clinical trial, 42% of the Phase 1 Patients achieved a CR/CRh (with 100% of the CRs and 83% of all responses being assessed as measurable residual disease (“MRD”) negative at the recommended phase 2 dose (“RP2D”), with a 7.6 months median duration of composite Complete Remission across all patients.

All patients treated with SENTI-202 showed a favorable safety profile.

On June 18, 2025, we announced that the FDA has granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia.

Also, on December 9, 2025, we announced that the FDA has granted SENTI-202 Regenerative Medicine Advanced Therapy (“RMAT”) designation.

The FDA granted the RMAT designation based on data from the Company’s ongoing Phase 1 clinical trial of SENTI-202 in adult patients with relapsed or refractory (R/R) CD33 and/or FLT3 expressing hematologic malignancies, including AML.

SENTI-202 has been designed to incorporate three chimeric proteins using a Logic Gated gene circuit and delivered through a single retrovirus.

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CD33 is typically found on bulk AML blasts and FLT3 is typically found on leukemic stem cells (“LSCs”).

LSCs are a rare sub-population of AML cells that possess stem cell like properties of self-renewal and drug resistance, contributing to relapse and poor prognosis after treatment.

LSCs are a rare sub-population of AML cells that possess stem cell like properties of self-renewal

and drug resistance, contributing to relapse and poor prognosis after treatment.

We believe that targeting FLT3 in addition to CD33 could result in deeper and more prolonged remissions.

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AML is a type of acute leukemia characterized by an accumulation of malignant immature white blood cells.

It is the most common type of acute leukemia in adults, constituting 80% to 85% of cases, and is the second most common—as well as the deadliest—in children.

It is the most common type of acute leukemia in adults, constituting 80% to 85% of

cases, and is the second most common—as well as the deadliest—in children.

Due to the absence of highly efficacious therapies, AML has poor prognosis with a low five-year survival rate at just 31.9%.

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SENTI-202 Clinical Data

We reported initial data from our Phase 1 clinical trial of SENTI-202 on December 2, 2024.

Initial data we reported included data related to the Initial 3 AML patients who were treated at the lowest dose level (1.0 billion CAR+ NK cells per dose, administered three times, on days 0, 7, and 14 of a 28-day cycle following lymphodepletion with fludarabine/cytarabine);

two of these patients achieved a CR, confirmed by bone marrow biopsy, which includes blast reduction and recovery of blood cells to normal ranges.

In addition, both patients were assessed as MRD negative after treatment, which is defined as no detectable cancer cells present in a bone marrow sample by the most sensitive locally available method.

As of December 2, 2024, both patients continued to maintain their remission (4+ months and 3+ months, respectively).

In all three patients, SENTI-202 was generally well-tolerated with an adverse event profile consistent with the use of lymphodepleting chemotherapy in patients with AML or low grade systemic symptoms such as fever that resolve with symptomatic care consistent with delayed infusion reactions reported for NK based cell therapies, often labeled as cytokine release syndrome by investigators with familiarity with commercial CAR T cell therapy side effects.

Both of the responding Initial 3 AML Patients continue in remission as of the date of the filing of this Annual Report on Form 10-K.

In addition to the Initial 3 AML Patients, we have enrolled and dosed other AML patients in our SENTI-202 clinical trial and have seen similar efficacy and safety results in the additional patients.

We anticipate releasing additional data on the SENTI-202 clinical trial at the 2025 AACR Annual Meeting to be held in April 2025.

We reported data from our Phase 1 clinical trial of SENTI-202 in 2024 and 2025.

Initial data we reported included data related to the Phase 1 patients who were treated at various dose levels following lymphodepletion with fludarabine/cytarabine).

Of the Phase 1 patients, there was a 50% overall response rate during our Phase 1 clinical trial, 42% of the Phase 1 patients achieved CR/CRh (with 100% of the CRs and 83% of all responses being assessed as measurable residual disease (“MRD”) negative at the recommended phase 2 dose (“RP2D”), with a 7.6 months median duration of composite Complete Remission across all patients.

All patients treated with SENTI-202 showed a favorable safety profile.

Development Plan and Key Next Steps for SENTI-202

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The study is designed to seamlessly expand and rapidly transition to a pivotal study assuming the data supports the expansion.

SENTI-301A for the Potential Treatment of HCC and Other Solid Tumors

SENTI-301A is a multi-armed gene circuit designed for the treatment of advanced GPC3 positive tumors and can be engineered into off-the-shelf healthy donor derived CAR-NK cell therapies.

SENTI-301 includes a CAR to target GPC3, which is highly expressed in 70% to 90% of HCCs and has low or no expression on normal adult tissues.

The SENTI-301A gene circuit is armed with our proprietary crIL-15 gene circuit, intended to simultaneously stimulate surrounding immune cells and promote NK cell expansion, persistence, and tumor killing.

In partnership with Celest Therapeutics, the SENTI 301A gene circuit is currently being studied in a pilot investigator sponsored single institution trial for the treatment of HCC in mainland China by being incorporated into Celest Therapeutics’ product candidate SN301A.

SN301A utilizes the SENTI-301A Gene Circuit technology developed by us and refers to the CAR-NK product candidate manufactured by Celest Therapeutics using Celest Therapeutics’ CAR NK manufacturing platform in China, which uses peripheral blood NK cells.

We are currently evaluating early clinical data with Celest Therapeutics, including certain dose limiting toxicities observed early in the clinical trial, to determine how best to continue development of our technology in SN301A.

The following figure illustrates the design of SENTI-301A/SN301A.

Hepatocellular Carcinoma:

an Unmet Medical Need

HCC accounts for approximately 90% of primary liver cancers and represents a large unmet medical need due to the lack of effective treatment options.

In the United States, the rate of death from liver cancer increased by 43% from 7.2 to 10.3 deaths per 100,000 people between 2000 and 2016.

In China, where we have partnered with Celest Therapeutics, there were approximately 370,000 new cases of HCC in 2022, accounting for over 40% of worldwide liver cancer diagnoses.

Available therapies are only modestly efficacious and the mortality rate in advanced HCC remains high despite recent improvements in treatment options.

The most effective therapy currently available for advanced HCC is atezolizumab plus bevacizumab combination therapy for first line treatment with a 28% objective response rate and a 7% complete response rate.

SENTI-301A Approach to Advanced HCC

The SENTI-301A gene circuit incorporates multiple anti-tumor activities to achieve a multi-armed attack on solid tumors.

Specifically, SENTI-301A includes:

An aCAR that targets GPC3, a highly expressed antigen in HCC and that has low or no expression on normal adult tissues.

crIL-15 to simultaneously stimulate surrounding immune cells and promote NK cell expansion, and persistence, and tumor killing.

GPC3 is a TAA expressed in approximately 70% to 90% of human HCCs and in 29-54% of other solid tumors (including lung, ovarian, and thyroid), but not expressed in healthy liver tissue or other human organs after birth.

GPC3 has previously been clinically evaluated as a therapeutic target for immunotherapy in HCC.

We engineered GPC3 CAR constructs to redirect NK-mediated cytotoxicity against advanced HCC using a GPC3 binder that associates to the membrane proximal region of the GPC3 protein.

IL-15 has been shown to improve NK cell persistence in vivo and maintain cytotoxicity.

Our proprietary crIL-15 gene circuit is designed to promote NK cell expansion, persistence, and tumor killing.

We believe that the ability of crIL-15 to secrete active IL-15 into the TME in a calibrated fashion should also enable stimulation of endogenous immune cells within the tumor microenvironment in solid tumor settings.

Development Plan and Key Next Steps for SN301A

In November 2023, we announced our strategic collaboration with Celest Therapeutics for the clinical development of SN301A, a product candidate that includes the SENTI-301A gene circuit, to treat solid tumors in China.

Celest Therapeutics will lead clinical development, operations, and manufacturing for the advancement of SN301A with technical, strategic, and clinical input from us.

Celest Therapeutics began dosing patients in the SN301A pilot study in the fourth quarter of 2024 and we observed dose limiting toxicities in early 2025.

We are evaluating the continuation of the SN301A pilot study with Celest Therapeutics and will continue to pursue development as appropriate.

Celest Therapeutics and we have the option to expand clinical development of SN301A to Hong Kong, Macau and Taiwan.

We retain all commercialization rights outside of mainland China, Hong Kong, Macau, and Taiwan for SENTI-301A.

The SN301A pilot study aims to evaluate the product candidate in patients with GPC3 positive advanced HCC in China.

Key features of the single institution investigator sponsored study design include:

• Lymphodepletion (LD) before product administration :

Celest Therapeutics plans to administer SN301A following fludarabine/cyclophosphamide lymphodepletion which has been widely used to support the expansion of NK cells in prior clinical trials.

• Multi-dose and multi-cycle administration :

The pilot study will evaluate various dose levels and schedules administered after LD.

After treatment, at the end of the fourth week, tumor response assessment will be performed utilizing imaging and biomarkers (and these 4 weeks make up one cycle).

At the end of a cycle, Celest Therapeutics will evaluate both efficacy and safety.

Patients may be eligible to receive additional cycles based on both tumor response and tolerability of treatment.

The study will evaluate efficacy and pharmacodynamic markers in addition to standard Phase 1 objectives of safety, pharmacokinetics and dose finding.

Our CAR-NK Cell Source

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NK cells sample potential target cells on a cell-by-cell basis to recognize transformed cells based on the balance of activating and inhibitory signals received by the NK cell from the individual target cell.

Other key differences of NK cells compared to T cells, which we believe make NK cells attractive candidates as cellular backbones for novel anti-cancer therapies, include:

Other key differences of NK

cells compared to T cells, which we believe make NK cells attractive candidates as cellular backbones for novel anti-cancer therapies, include:

• Lack of explosive proliferation and outpouring of cytokines when exposed to target cells, have shown to result in an improved safety profile and to allow repeat dosing due to a general lack of chimeric antigen receptor (“CAR”) T cell-like adverse events such as cytokine release syndrome (“CRS”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”),

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Our additional discovery efforts are focused on a diverse set of cell and gene therapy applications outside of oncology.

We have entered into collaborations with Spark Therapeutics (subsidiary of Roche Holding AG) for the design of Smart Sensors for disease- and tissue-specific gene therapy, and with BlueRock Therapeutics (subsidiary of Bayer AG) for the use of Smart Sensors and Regulator Dials for regenerative medicines.

We previously entered into collaborations with Spark Therapeutics (subsidiary of Roche Holding AG) for the design of Smart Sensors for disease- and tissue-specific gene therapy.

That collaboration has terminated.

We also previously entered into a collaboration with BlueRock Therapeutics (subsidiary of Bayer AG) for the use of Smart Sensors and Regulator Dials for regenerative medicines.

Tumor-Associated Antigen and Protective Antigen Paired Discovery Platform

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(“Valere Bio” or “Valere”) a wholly-owned subsidiary of Celadon Partners LLC (“Celadon Partners” or “Celadon”), a private equity group, who created a new independent contract manufacturing organization for cell and gene therapy, and synthetic biology biofoundry called GeneFab, LLC (“GeneFab”).

In connection with the transaction, we were entitled to receive total consideration of $37.8 million before the end of 2025, of which $18.9 million was due at closing and was netted against a prepayment owed by us for manufacturing and research activities to GeneFab.

In connection with the transaction, we were entitled to receive total consideration of $37.8 million, of which $18.9 million was due at closing and was netted against a prepayment owed by us for manufacturing and research activities to GeneFab.

We also received $8 million in manufacturing services credit and subleased our 92,000 square foot good manufacturing practice (“cGMP”) facility in Alameda, CA to GeneFab.

That facility lease has subsequently been amended to include approximately half of the original space for GeneFab to perform its manufacturing.

Refer to Item 8.

“Financial Statements and Supplementary Data —Notes to Consolidated Financial Statements — Note 15 — Subsequent Events” in this Annual Report on Form 10-K for details on the lease and sublease amendments.

The remaining consideration of $18.9 million was waived by us and GeneFab in connection with an investment by Celadon Partners, the sole investor in GeneFab, into our 2024 PIPE transaction described herein.

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In July 2020, we entered into an Exclusive/Co-Exclusive Patent License Agreement, as amended, (“NCI FLT3 Agreement”) with the U.S.

Department of Health and Human Services, as represented by the National Cancer Institute, or the NCI, under which the NCI granted us a worldwide, royalty-bearing, sublicensable license under the NCI’s patent rights related to FLT3-targeting chimeric antigen receptor, or CAR, technology (i) exclusively for the development of a universal or split CAR-based immunotherapy using T-cells or NK cells transduced with lentiviral vectors or other retroviral vectors, depending on the cell type, for the prophylaxis or treatment of cancers expressing FMS-like tyrosine kinase 3, or FLT3, where the CAR construct binds to specific domains and (ii) co-exclusively, with a third party, for the development of a multi-specific FLT3 CAR-based immunotherapy or FLT3-specific regulated or switch or Logic Gated CAR-based immunotherapy using T-cells or NK cells transduced with lentiviral

vectors or other retroviral vectors, depending on the cell type, for the prophylaxis or treatment of FLT3-expressing cancers, where the CAR construct contains specific domains, in each case of (i) and (ii), to make and have made, use and have used, sell and have sold, offer to sell and import products covered by the licensed patent rights and to practice and have practiced processes covered by the licensed patent rights.

Department of Health and Human Services, as represented by the National Cancer Institute, or the NCI, under which the NCI granted us a worldwide, royalty-bearing, sublicensable license under the

NCI’s patent rights related to FLT3-targeting chimeric antigen receptor, or CAR, technology (i) exclusively for the development of a universal or split CAR-based immunotherapy using T-cells or NK cells transduced with lentiviral vectors or other retroviral vectors, depending on the cell type, for the prophylaxis or treatment of cancers expressing FMS-like tyrosine kinase 3, or FLT3, where the CAR construct binds to specific domains and (ii) co-exclusively, with a third party, for the development of a multi-specific FLT3 CAR-based immunotherapy or FLT3-specific regulated or switch or Logic Gated CAR-based immunotherapy using T-cells or NK cells transduced with lentiviral vectors or other retroviral vectors, depending on the cell type, for the prophylaxis or treatment of FLT3-expressing cancers, where the CAR construct contains specific domains, in each case of (i) and (ii), to make and have made, use and have used, sell and have sold, offer to sell and import products covered by the licensed patent rights and to practice and have practiced processes covered by the licensed patent rights.

In addition to the co-exclusive rights held by a third party, the foregoing license is subject to (a) certain rights of the United States government, including an irrevocable, non-exclusive, non-transferable, royalty-free license for the government to practice all licensed patent rights throughout the world and (b) the NCI’s reserved rights to grant a non-exclusive license to practice the licensed patent rights for purposes of internal research (and not for purposes of commercial manufacture or distribution) at an academic or corporate facility.

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In May 2021, we entered into an Exclusive Patent License Agreement (“NCI CD33 Agreement), with the U.S.

Department of Health and Human Services, as represented by the NCI, under which the NCI granted us an exclusive, royalty-bearing, sublicensable, worldwide license under the NCI’s patent rights related to CD33 targeting CAR technology to make and have made, use and have used, sell and have sold, offer to sell and import products covered by the licensed patent rights and to practice and have practiced processes covered by the licensed patent rights, for the development of a CD33-specific logic-gated CAR-based immunotherapy using autologous human T cells transduced with lentiviral vectors or off-the-shelf human NK cells transduced with retroviral vectors for the

prophylaxis or treatment of CD33-expressing cancers.

The foregoing license is subject to (i) certain rights of the United States government, including an irrevocable, non-exclusive, nontransferable, royalty-free license for the government to practice all licensed patent rights throughout the world and (ii) the NCI’s reserved rights to grant a non-exclusive license to practice the licensed patent rights for purposes of internal research (and not for purposes of commercial manufacture or distribution) at an academic or corporate facility.

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In April 2021, we entered into a Research Collaboration and License Agreement (“Spark Agreement”), with Spark Therapeutics.

Under the Spark Agreement, we engaged in a collaborative research program with Spark Therapeutics to design, build and test synthetic promoters that are intended to have each one of five sets of desired characteristics, or promoter profiles.

Under the Spark Agreement, we engaged in a collaborative research program with Spark

Therapeutics to design, build and test synthetic promoters that are intended to have each one of five sets of desired characteristics, or promoter profiles.

Spark Therapeutics is obligated to reimburse us for our costs and expenses incurred in connection with the conduct of the research program.

Upon completion of work under the research program for a particular promoter profile, Spark Therapeutics may select and designate, subject to a specified maximum, a certain number of synthetic promoters that are designed, built and tested or identified by us under the research program with respect to such promoter profiles as optioned promoters.

commercialize and otherwise exploit, for the cure, treatment, palliation, prevention or diagnosis of specified indications, or a licensed field, in vivo gene therapy products incorporating such applicable optioned promoter with respect to such promoter profile and is directed towards specific cell types in the central nervous system, eye, or liver.

On a promoter profile-by-promoter-profile basis, for each optioned promoters, Spark Therapeutics will have the right to obtain an exclusive, royalty-bearing, sublicensable, worldwide license under our intellectual property rights to develop, manufacture, commercialize and otherwise exploit, for the cure, treatment, palliation, prevention or diagnosis of specified indications, or a licensed field, in vivo gene therapy products incorporating such applicable optioned promoter with respect to such promoter profile and is directed towards specific cell types in the central nervous system, eye, or liver.

Spark Therapeutics may exercise its option for any optioned promoter prior to the expiration of the applicable evaluation period.

After exercise of an option, Spark Therapeutics will be responsible for all development, manufacture, commercialization and exploitation in the licensed field, at its own cost and expense, of all in vivo gene therapy products containing an applicable licensed promoter, and we will retain the right to develop, manufacture, commercialize and exploit other products that incorporate the licensed promoters as well as in vivo gene therapy products that incorporate the licensed promoters for uses outside the licensed field.

If Spark Therapeutics does not exercise an option for a particular promoter profile prior to the expiration of the evaluation period for such promoter profile, we will retain all rights to the synthetic promoters developed under the Spark Agreement without any further obligations to Spark Therapeutics for such promoter profile.

Spark Therapeutics opted to not exercise its option following completion of the research under this collaboration.

Pursuant to the Spark Agreement, we received an upfront payment from Spark Therapeutics of $3 million.

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Bayer Healthcare LLC’s parent company is Bayer AG, which served as the lead investor in our Series B financing through its Leaps by Bayer unit.

We amended the BlueRock Agreement effective September 4, 2025, to, among other things, extend BlueRock’s research term in order to further facilitate its research thereunder.

Under the BlueRock Agreement, we have engaged in three collaboration programs with BlueRock to research and develop gene circuits that have specified functions.

We are responsible for up to $10 million in costs and expenses incurred in connection with our conduct of research activities under an agreed-upon research plan.

If the parties mutually agree to add new research activities to the research plan, then BlueRock will be obligated to reimburse us for the costs and expenses that we incur in connection with the agreed-upon additional research activities that, together with costs and expenses incurred under the initial research plan, exceed $10 million.

incurred under the initial research plan, exceed $10 million.

We have not yet received any payment from BlueRock under the BlueRock Agreement and we do not have any obligations to make any payments to BlueRock under the BlueRock Agreement.

We are obligated to use

commercially reasonable efforts to conduct the research activities assigned to us under the research plan.

We are obligated to use commercially reasonable efforts to conduct the research activities assigned to us under the research plan.

If we materially breach that obligation and do not cure it within a specified period, BlueRock will have the right to receive a transfer of technology and perform the remainder of the research plan at its own expense.

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This right of first negotiation does not overlap with the option described above because it pertains to different combinations of fields, cell types and gene circuits.

Starting from the effective date of the BlueRock Agreement and, on a collaboration program-by-collaboration program basis, continuing for twelve months or, if later, until the completion of a certain portion of the research plan for such collaboration program, we are obligated to work exclusively with BlueRock on the development, manufacture and commercialization, in the negotiation field, of cell therapy products containing negotiation cells that incorporate the specific type of gene circuit for such collaboration program.

commercial license, the expiration of the applicable negotiation or baseball arbitration period for the commercial license, or the date the parties mutually agree to cease negotiations for the commercial license.

Starting from the effective date of the BlueRock Agreement and, on a collaboration program-by-collaboration program basis, continuing for 12 months or, if later, until the completion of a certain portion of the research plan for such collaboration program, we are obligated to work exclusively with BlueRock on the

development, manufacture and commercialization, in the negotiation field, of cell therapy products containing negotiation cells that incorporate the specific type of gene circuit for such collaboration program.

The BlueRock Agreement will expire, on a collaboration program-by-collaboration program basis, upon the earliest of the expiration of the option exercise period for such collaboration program, the effective date of the commercial license, the expiration of the applicable negotiation or baseball arbitration period for the commercial license, or the date the parties mutually agree to cease negotiations for the commercial license.

Such expiration shall occur no later than January 2026 unless the parties mutually agree to extend the research term.

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We may terminate the NCI GPC3 Agreement in its entirety or with respect to a country for any reason by providing 60 days’ prior written notice to the NCI.

The NCI may terminate the NCI GPC3 Agreement if (i) we breach any material obligations under the NCI GPC3 Agreement and fail to cure such breach within 90 days after receiving written notice thereof, or (ii) if the NCI reasonably determines that (a) we are not executing the commercial development plan, including the milestones specified therein, (b) we have willfully made a false statement or omitted a material fact in our license application or any report to the NCI, (c) we have committed a material breach of a covenant or agreement to the NCI, (d) we are not keeping the licensed products or licensed services reasonably available to the public after commercial use commences, (e) we cannot reasonably satisfy unmet health and safety needs, (f) we cannot reasonably justify a failure to comply with the domestic production requirement or (g) we have been found by a court to have violated antitrust laws in connection with our performance under the NCI GPC3 Agreement, in each case of (a) through (f), where we fail to alleviate the NCI’s concerns in 90 days.

Additionally, the NCI reserves the right to terminate or modify the NCI GPC3 Agreement if the NCI determines that such action is

necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by us.

available to the public after commercial use commences, (e) we cannot reasonably satisfy unmet health and safety needs, (f) we cannot reasonably justify a failure to comply with the domestic production requirement or (g) we have been found by a court to have violated antitrust laws in connection with our performance under the NCI GPC3 Agreement, in each case of (a) through (f), where we fail to alleviate the NCI’s concerns in 90 days.

Additionally, the NCI reserves the right to terminate or modify the NCI GPC3 Agreement if the NCI determines that such action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by us.

Framework Agreement with GeneFab, LLC

On August 7, 2023, we entered into a framework agreement, (the “Framework Agreement”), with GeneFab, LLC, a Delaware limited liability company, or GeneFab, and Valere Bio, Inc., a Delaware corporation and the parent company of GeneFab, (“Valere”), which is wholly owned by a company managed by Celadon Partners, pursuant to which we, subject to the terms and conditions therein, (i) sold, assigned and transferred its rights, title and interest in certain of the assets and contractual rights to GeneFab, including all of our equipment and leasehold improvements at our facilities in Alameda, California (the “Alameda Facility”) and certain of our intellectual property related to the schematics for and design of the Alameda Facility, and (ii) subleased to GeneFab its premises under the lease for the Alameda Facility (a portion of which is subject to the satisfaction of certain conditions), or collectively, the Purchased Assets.

On August 7, 2023, we entered into a framework agreement, (the “Framework Agreement”), with GeneFab, LLC, a Delaware limited liability company, or GeneFab, and Valere Bio, Inc., a Delaware corporation and the parent company of GeneFab, (“Valere”), which is wholly owned by a company managed by Celadon Partners, pursuant to which we, subject to the terms and conditions therein, (i) sold, assigned and transferred its rights, title and interest in certain of the assets and contractual rights to GeneFab, including all of our equipment and leasehold improvements at our facilities in Alameda, California (the “Alameda Facility”) and certain of our intellectual property related to the schematics for and design of the Alameda Facility, and (ii) subleased to GeneFab its premises under the lease, which has subsequently been amended in March 2026, for the Alameda Facility (a portion of which is subject to the satisfaction of certain conditions), or collectively, the Purchased Assets.

Refer to Item 8.

In addition, we agreed to grant a license to GeneFab under certain of its intellectual property rights to conduct manufacturing services and to research, develop, manufacture and commercialize products outside of oncology, pursuant to a license agreement under negotiation (“the License Agreement”).

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The GeneFab Option may be exercised in installments of common stock equal to no more than 19.9% of our outstanding shares of common stock as of the closing date of the transaction.

As additional consideration for the transaction, we entered into a seller economic share agreement with GeneFab, pursuant to which we will be entitled to receive ten percent of the realized gains of GeneFab’s parent company arising and resulting from any cash or in-kind distributions from GeneFab in connection with a dividend or sale event, subject to the terms and conditions of the GeneFab Economic Share.

On December 10, 2024, in connection with the private placement described in further detail in Note 7.

Stockholders’ Equity in Part II - Item 8, Financial and Supplementary Data - Notes to Consolidated Financial Statements of this Annual Report on Form 10-K, the Company entered into an amendment of the GeneFab Framework Agreement with GeneFab and Valere Bio, Inc.

As additional consideration for the transaction, we entered into a seller economic share agreement with GeneFab (“GeneFab Economic Share”), pursuant to which we will be entitled to receive ten percent of the realized gains of GeneFab’s parent company arising and resulting from any cash or in-kind distributions from GeneFab in connection with a dividend or sale event, subject to the terms and conditions of the GeneFab Economic Share.

On December 10, 2024, in connection with the private placement described in further detail in Part II, Item 8.

“Financial Statements and Supplementary Data —Notes to Consolidated Financial Statements — Note 6 — Stockholders’ Equity” in this Annual Report on Form 10-K, we entered into an amendment of the GeneFab Framework Agreement with GeneFab and Valere Bio, Inc.

As part of the agreement, the GeneFab Note Receivable was waived by the parties.

Additionally, the Company entered into an amended and restated development and manufacturing services agreement.

Additionally, we entered into an amended and restated development and manufacturing services agreement with GeneFab.

Collaboration and Option Agreement with Celest Therapeutics, (Shanghai) Co.

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Under the Celest Agreement, we agreed to collaborate with Celest Therapeutics for Celest Therapeutics to carry out an investigator-initiated trial (“IIT”) of the SENTI-301A gene circuit in Celest Therapeutics’ SN301A product candidate (manufactured by Celest) in mainland China with certain technical support from us.

Celest Therapeutics will have an exclusive option to obtain an exclusive, royalty-bearing, license in mainland China, Hong Kong, Macau, and Taiwan under our intellectual property rights to research, develop, manufacture, commercialize and otherwise exploit an off-the-shelf CAR-NK cell therapy product candidate that consists of NK cells that have been engineered to express our CAR having an antigen binding portion that is directed to GPC3 and our crIL15, such product candidate the SN301A Product.

Celest initiated a Phase 1 clinical trial for SN301A in China in 2024.

Based on the observation of certain dose limiting toxicities in the SN301A Investigator Sponsored Trial (the “SN301A Trial”), Celest decided to cease enrollment of the clinical trial in April 2025.

Under our agreement with Celest, Celest Therapeutics has an exclusive option to obtain an exclusive, royalty-bearing, license in mainland China, Hong Kong, Macau, and Taiwan under our intellectual property rights to research, develop, manufacture, commercialize and otherwise exploit SN301A, an off-the-shelf CAR-NK cell therapy product candidate that consists of NK cells that have been engineered to express our CAR having an antigen binding portion that is directed to GPC3 and our crIL15.

Celest Therapeutics may exercise its option prior to the expiration of a certain time period (the “option exercise period”).

If Celest Therapeutics exercises its option during the option exercise period, the parties shall negotiate the terms of the license agreement, which will

include and be consistent with pre-agreed financial terms, and Celest Therapeutics will be required to pay us an option exercise fee in the mid-single digit millions upon the execution of the license agreement.

If Celest Therapeutics exercises its option during the option exercise period, the parties shall negotiate the terms of the license agreement, which will include and be consistent with pre-agreed financial terms, and Celest Therapeutics will be required to pay us an option exercise fee in the mid-single digit millions upon the execution of the license agreement.

If the parties enter into a license agreement having terms consistent with the pre-agreed financial terms, we will be eligible to receive certain option exercise fee and milestone payments, in an aggregate amount of $156.0 million, as well as certain tiered royalty payment.

During a certain time period (the “exclusivity period”), we are prohibited from directly or indirectly, exploiting or enabling any third party to research, develop manufacture, commercialize or otherwise exploit in mainland China any off-the-shelf CAR-NK cell therapy having an antigen binding portion of the CAR directed to GPC.

If Celest Therapeutics does not exercise its option, then the exclusivity period will end on the expiration of the option period.

If Celest Therapeutics exercises its option, then the exclusivity period will end upon the expiration of the applicable negotiation period for the license agreement or the mutual execution of the license agreement, whichever is earlier.

If Celest Therapeutics exercises its option and the parties are unable to execute a mutually agreed license agreement during the negotiation period, then the option will automatically be deemed expired and we will have no further obligation to Celest Therapeutics under the Celest Agreement, except that for a certain time period following the expiration of the negotiation period, Celest Therapeutics will have certain rights if we receive a bona fide offer from a third party for such third party to obtain an exclusive license or similar exclusive rights under our technology to research, develop, manufacture, commercialize or otherwise exploit the SN301A Product in certain territories on certain terms and Celest Therapeutics will have certain rights if we enter into any arrangement with any third party pursuant to which we grant an exclusive license or similar exclusive right under technology to research ,develop, manufacture, commercialize or otherwise exploit the SN301A Product in certain territories on certain terms.

Based on the initial results of the SN301A Trial, we do not anticipate that Celest will exercise its option.

The Celest Agreement will expire upon the earliest of the expiration of the option exercise period, the expiration of the negotiation period of the license agreement, or on the date of execution of the license agreement.

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and alternative technologies, and our patents and patent application include claims directed to compositions, methods (including preparation, use, or treatment), processes, dosing and formulations.

As of March 12, 2025, our in-licensed and owned patent portfolio consists of over 13 issued patents and 214 pending patent applications, of which we own or co-own 5 patents and 194 pending patent applications, and have licensed 8 patents and 20 pending patent applications.

As of March 19, 2026, our in-licensed and owned patent portfolio consists of over 15 issued patents and 237 pending patent applications, of which we own or co-own 215 pending patent applications, and have licensed 3 patents and 22 pending patent applications.

The term of a patent in our patent portfolio varies depending upon a number of factors such as the date of filing of the patent application, the date of patent issuance and the legal term of patents in the countries in which they are obtained.

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We also utilize trademark rights to protect our brand and have filed trademark applications for the marks “SENTI,” “SENTI BIOSCIENCES,” “SENTI BIO,” and Senti’s “S” logo in the United States and in certain marks in foreign countries.

As of March 12, 2025, we own five United States trademark registrations, one pending and/or allowed United States trademark applications, and five foreign trademark registrations.

As of March 19, 2026, we own six United States trademark registrations, one pending and/or allowed United States trademark applications, and five foreign trademark registrations.

We have also registered multiple internet domain names to further supplement the protection of our brand.

Government Regulation

Food and Drug Administration, or FDA, and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record

keeping, approval, advertising, promotion, marketing, sampling post-approval monitoring and post-approval reporting of biologics such as those we are developing.

manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, sampling post-approval monitoring and post-approval reporting of biologics such as those we are developing.

Any product candidates that we develop must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in those foreign countries.

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These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

In the case of some products for severe or life-

threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

• Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, dose tolerance and dosing schedule and to identify possible adverse side effects and safety risks.

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The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional information.

event, the BLA must be resubmitted with the additional information.

The resubmitted application also is subject to review before the FDA accepts it for filing.

Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing.

In both standard and priority reviews, the review process may also be extended by FDA

requests for additional information or clarification.

In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or clarification.

The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency.

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For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks, or otherwise limit the scope of any approval.

A REMS is a safety strategy implemented to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications.

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Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a biologic or indication approved under accelerated approval if, for example, the sponsor fails to conduct the required post-marketing studies or if such studies fail to verify the predicted clinical benefit.

In addition, for products being considered for accelerated approval, the FDA generally requires, unless otherwise informed by FDA, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to FDA for review during the pre-approval period.

In addition, for products being considered for

accelerated approval, the FDA generally requires, unless otherwise informed by FDA, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to FDA for review during the pre-approval period.

The FDA established a new regenerative medicine advanced therapy, or RMAT, designation, which is intended to facilitate an efficient development program for, and expedite review of, any biologic that meets the following criteria:

(i) the biologic qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited

(ii) the biologic is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition;

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Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

On June 18, 2025, we announced that the FDA has granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia.

In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

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Competitors may receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity.

Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same biological product as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.

Orphan product exclusivity also could block the approval of one of our products for seven years if a

competitor obtains approval of the same biological product as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.

In addition, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or, as noted above, if a second applicant demonstrates that its product is clinically superior to the approved product with orphan exclusivity or the manufacturer of the approved product is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Regenerative Medicine Advanced Therapy (RMAT) Designation

As part of the 21st Century Cures Act, Congress created the Regenerative Medicine Advanced Therapy (“RMAT”) designation to facilitate an efficient development program for, and expedite review of, a product candidate that meets the following criteria:

(1) it qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions;

(2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition;

and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.

A sponsor may request that the FDA designate a drug as a RMAT concurrently with or at any time after submission of an IND.

The FDA has 60 calendar days to determine whether the drug meets the criteria.

A BLA for a regenerative medicine therapy that has received RMAT designation may be eligible for priority review or accelerated approval through use of surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites.

Benefits of RMAT designation also include early interactions with FDA to discuss any potential surrogate or intermediate endpoint to be used to support accelerated approval.

A regenerative medicine therapy with RMAT designation that is granted accelerated approval and is subject to post-approval requirements may, as appropriate, fulfill such requirements through the submission of clinical evidence from clinical trials, patient registries, or other sources of real world evidence, such as electronic health records;

the collection of larger confirmatory data sets;

or post-approval monitoring of all patients treated with such therapy prior to its approval.

Like some of FDA’s other expedited development programs, RMAT designation does not change the standards for approval but may help expedite the development or approval process.

The FDA granted SENTI-202 an RMAT designation in December 2025.

Post-Approval Requirements

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Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others.

Newly discovered or developed safety or effectiveness data

may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures.

Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics.

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Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances.

The FDA does not regulate the behavior of physicians in their choice of treatments.

The FDA does not regulate the

behavior of physicians in their choice of treatments.

The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

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Pediatric exclusivity, if granted, adds six months to existing regulatory exclusivity periods for all formulations, dosage forms, and indications of the active moiety.

This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study, provided that at the time pediatric exclusivity is granted there is not less

than nine months of term remaining.

The BPCIA is complex and continues to be interpreted and implemented by the FDA.

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Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels.

There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities.

comparable foreign regulatory authorities.

In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S.

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The requirements governing drug pricing vary widely from country to country.

For example, the

European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

For example, the European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies.

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In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs.

For example, in 2010, the Patient Protection and Affordable Care Act (the “ACA”) was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S.

impacted the U.S.

pharmaceutical industry.

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Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs.

The Inflation Reduction Act of 2022, or IRA, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap;

The Inflation Reduction Act of 2022, or IRA, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for

Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap;

impose new manufacturer financial liability on certain drugs under Medicare Part D;

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Healthcare providers, physicians and third-party payors, among others, will play a primary role in the prescription and recommendation of any product candidates for which we obtain marketing approval.

Our arrangements with third-party payors, providers and customers, among others, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations in the future that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our product candidates for which we obtain marketing approval.

obtain marketing approval.

Restrictions under applicable federal and state healthcare laws and regulations in the United States and other countries, include the following:

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HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

In addition, there may be additional federal, state, and non-

In addition, there may be additional federal, state, and non-U.S.

laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

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In April 2014, the European Union adopted a Clinical Trials Regulation (EU) No 536/2014, which replaced the Clinical Trials Directive 2001/20/EC on January 31, 2022.

The Clinical Trials Regulation is directly applicable in all Member States (and so does not require national implementing legislation in each Member State), and aims at simplifying and streamlining the approval of clinical studies in the

European Union.

For example, a single application is now made through the Clinical Trials Information System, for clinical trial authorization in up to 30 European Economic Area (“EEA”) (comprised of the EU Member States plus Norway, Iceland and Liechtenstein) countries at the same time and with a single set of documentation.

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• The centralized marketing authorization is issued by the European Commission through the centralized procedure, based on the opinion of the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”), and is valid throughout the entire territory of the EU.

The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases.

The centralized

procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases.

The centralized procedure is optional for products containing a new active substance not yet authorized in the European Union, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the European Union.

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During the additional two-year period of market exclusivity, a biosimilar or generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no biosimilar or generic product can be marketed in the EU until the expiration of the market exclusivity.

The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or

more new therapeutic indications which, during the scientific evaluation prior to their authorization, are determined to bring a significant clinical benefit in comparison with currently approved therapies.

The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are determined to bring a significant clinical benefit in comparison with currently approved therapies.

However, there is no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity.

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Under Article 3 of Regulation (EC) 141/2000, the European Commission grants an orphan designation in respect of a product if its sponsor can establish that (1) the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

(2) either (a) such condition affects no more than five in 10,000 persons in the European Union when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify the necessary investment in its development;

(2) either (a) such

condition affects no more than five in 10,000 persons in the European Union when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify the necessary investment in its development;

and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000.

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Once the European Commission’s legislative proposals are approved (with or without amendment), they will be adopted into European Union law.

For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical studies, product licensing, pricing and reimbursement vary from

country to country.

In all cases, again, the clinical studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

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We consider our relationship with our employees to be good.

Of our executive officers, sixty-seven percent (67%) are people of color and sixty-seven percent (67%) are women.

With respect to our employees overall, approximately seventy-five percent (75%) are people of color and approximately forty percent (40%) are women.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees.

The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based

compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

We currently occupy approximately 40,000 square feet of office and research and development space in South San Francisco, CA under a lease that expires in April 2027, with an option to extend for an additional eight years.

We entered into a sublease agreement with GeneFab LLC to sublease approximately 7,400 square feet of our office space in South San Francisco expiring April 2027.

We entered into a sublease agreement with GeneFab to sublease approximately 7,400 square feet of our office space in South San Francisco expiring April 2027.

On March 9, 2026, we and GeneFab agreed to terminate the sublease, effective March 31, 2026.

We also entered into a sublease agreement with BKPBIOTECH, Inc.

and JLSA Therapeutics, Inc., to sublease approximately 7,600 square feet of our office space in South San Francisco commencing October 2024 and also expiring April 2027.

Therapeutics, Inc.

to sublease approximately 11,001 square feet of our office space in South San Francisco commencing October 2024 and also expiring April 2027.

In June 2023, we completed the build-out of a cell therapy manufacturing facility designed to meet cGMP.

We subsequently subleased this 92,000 square feet of manufacturing space under an agreement with GeneFab that was executed in August 2023, with such sublease expiring in September 2032.

On March 17, 2026 we entered into a First Amendment to Lease (the “Lease Amendment”), a First Amendment to Sublease (the “Sublease Amendment”), a First Amendment to Landlord’s Consent to Sublease (the “Consent Amendment”) and a Letter Agreement (the “GeneFab Letter Agreement”) all related to the Alameda Facility with GeneFab and 1430 South Loop Owner, LLC (the “Landlord”), pursuant to which we reduced the leased premises from approximately 92,000 rentable square feet to approximately 46,000 rentable square feet.

The Lease Amendment also reduces our future base rent obligations for the remaining term of the lease and modifies certain cost-sharing arrangements with respect to operating expenses, taxes, and utilities.

We believe that this space, collectively, is sufficient to meet our existing needs.

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

What changed 10-K

Item 1. Business