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Item 1. Business

2025-03-20 compared with 2024-03-21 · 183 added, 175 removed, 646 unchanged (36% of the section changed)

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Using gene circuits, our product candidates are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration.

We are applying our gene circuit technologies to develop a pipeline of medicines that use off-the-shelf chimeric antigen receptor natural killer (“CAR-NK”) cells with the goal of addressing major challenges and providing potentially lifesaving treatments for people living with cancer.

Our lead product candidates utilize off-the-shelf healthy adult donor derived NK cells to create CAR-NK cells outfitted with Gene Circuit technologies in several oncology indications with high unmet need.

We expect to initiate clinical trials of two of our product candidates in 2024.

Our lead product candidate SENTI-202, a potentially first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for the treatment of acute myeloid leukemia (“AML”), received clearance of its Investigational New Drug application (“IND”) by the U.S.

Food and Drug Administration (“FDA”) in December 2023, and we anticipate dosing the first patient with SENTI-202 in the second quarter of 2024.

Our second clinical development program SENTI-301A, a multi-armed off-the-shelf healthy donor derived CAR-NK cell therapy, is expected to begin in the second quarter of 2024.

We are primarily focused on off-the-shelf CAR-NK cell therapy programs for oncology indications.

Our lead product candidate, SENTI-202, is on track to begin dosing patients in a Phase 1 clinical trial for the treatment of hematological malignancies including AML in the second quarter of 2024.

We also have three partnered programs:

(i) our SENTI-301A pipeline program for the treatment of HCC is partnered in China with Celest Therapeutics, (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.

We are applying our gene circuit technologies to develop a pipeline of medicines that use chimeric antigen receptor (“CAR”) white blood cells with the goal of addressing major challenges and providing potentially lifesaving treatments for people living with cancer.

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.

(“BlueRock Therapeutics”).

Our most advanced programs, SENTI-202 and SENTI-301A, originate from our internal pipeline of off-the-shelf CAR-NK programs.

Our most advanced programs, SENTI-202 and SENTI-301A, originate 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 off-the-shelf CAR-NK cell 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 allogeneic cell therapy products for the treatment of cancer.

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.

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

We believe achieving this goal will play a critical role in addressing major challenges in oncology and providing potentially lifesaving treatments for people living with cancer.

Key elements of our strategy include:

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

▪ Advance the clinical development of the SENTI-301A program work through a strategic partnership with Celest Therapeutics;

• Leverage partnering to support non-oncology indications, 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 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;

• 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”).

SENTI-202 for the Potential Treatment of Hematologic Malignancies including Acute Myeloid Leukemia

including AML, while sparing healthy bone marrow cells.

We are on track to begin clinical trials in the United States and Australia in 2024 with the first patient anticipated to be dosed in the second quarter of 2024.

Our lead product candidate SENTI-202 is a potentially first-in-class Logic Gated off-the-shelf CAR-NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, including AML, while sparing healthy bone marrow cells, even if they express CD33 and/or FLT3 due to our unique NOT gate design.

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.

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

In order to protect the healthy cells that express FLT3, the second chimeric protein we have engineered SENTI-202 to include is an inhibitory CAR (“iCAR”), which we refer to as a NOT Gate, to protect the healthy cells from potential on-target/off-tumor toxicity.

In addition to attacking cancer cells, in an attempt to protect the healthy cells that express FLT3 during treatment, the second chimeric protein we have engineered SENTI-202 to include is an inhibitory CAR (“iCAR”), which we refer to as a NOT Gate, to protect the healthy cells from potential on-target/off-tumor toxicity.

The iCAR is designed to recognize the healthy cell surface protein endomucin (“EMCN”).

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The following figure illustrates the design of SENTI-202 Logic Gating gene circuits to kill AML LSCs and blasts, while sparing healthy HSCs via (CD33 OR FLT3) NOT EMCN logic.

Acute Myeloid Leukemia (AML):

Acute Myeloid Leukemia:

an Unmet Medical Need

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The treatment at diagnosis for the majority of patients who cannot tolerate the toxicities of intensive chemotherapy includes either hypomethylating agents or low-dose cytosine arabinoside (“Ara-C”, also known as cytarabine), as monotherapy or in combination with venetoclax, or best supportive care.

In patients who can tolerate more intensive treatments, the goal of treatment is to induce a complete remission (“CR”) with intensive chemotherapy and consolidate with allogeneic hematopoietic cell transplantation (“HCT”).

In patients who can tolerate more intensive treatments, the goal of treatment is to induce a complete response (“CR”) with intensive chemotherapy and consolidate with allogeneic hematopoietic cell transplantation (“HCT”).

Treatment is combined with the respective targeted agents in patients who have CD33‑positive disease or a FLT3‑mutated disease (Mylotarg USPI;

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Other therapies for AML include targeted agents for the minority of patients with either isocitrate dehydrogenase (IDH)-1 or IDH-2 mutated disease.

Despite these therapies being recently approved for patients with AML, the prognosis continues to be poor with the majority of patients refractory to or relapsing from front-line therapy and a median overall survival (OS) of 5 months at relapse.

Development of targeted AML treatments is difficult because the disease is highly heterogeneous.

More than 200 types of chromosome translocations and mutations have been identified in AML patients.

Therapies targeting a single TAA are therefore often insufficient to kill all the cancer cell subsets in AML, leading to eventual disease relapse.

As such, therapies targeting a single TAA are often insufficient to kill all the cancer cell subsets in AML, leading to eventual disease relapse.

To drive patients into deeper remissions and prevent relapses, therapies designed to target multiple AML antigens are needed.

Additionally, recent studies suggest relapse is associated with the less targeted AML subpopulation of LSCs;

Thus, the development of therapies targeting AML LSCs is sorely needed, but this has been

challenging because LSC targets are often expressed on healthy cells, such as HSCs, leading to on-target, off-tumor treatment-induced toxicities.

however, while the development of therapies targeting AML LSCs is much needed, this strategy has been particularly challenging because LSC targets are often expressed on healthy cells, such as HSCs, leading to on-target, off-tumor treatment-induced toxicities.

CAR Cell Therapy for AML

The therapeutic administration of CAR cell therapies has considerably advanced the treatment of certain cancers, such as B-cell malignancies.

However, the successes of CAR cell therapies have not yet translated to successful treatment of AML, in part due to the absence of AML-specific target antigens.

The therapeutic administration of CAR cell therapies has considerably advanced the treatment of certain cancers, such as B-cell malignancies, but the successes of CAR cell therapies have not yet translated to successful treatment of AML, in part due to the absence of AML-specific target antigens.

Due to their nonrestrictive expression, most AML antigens are also expressed on healthy HSCs or myeloid cells.

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These described challenges also extend to other potential AML therapeutic modalities, such as antibodies and bispecific T cell engagers.

SENTI-202 Preclinical Data

In preclinical studies, as shown below, in comparison to non-engineered NK cells, SENTI-202 CAR-NK cells exhibited increased and more consistent cell killing across a variety of primary patient AML or MDS blasts, or AML leukemia stem cells in vitro .

Similarly, in a luciferase tagged MV4-11 AML xenogenic tumor model in immunocompromised mice, decreased bioluminescence indicating decrease in AML tumor burden, and increased survival were observed when the mice were treated with a single dose of SENTI-202 compared to non-engineered NK cells or vehicle control.

AML cell line or healthy primary HSCs were co-cultured with either a CAR-NK cell that only expressed the aCAR (i.e.

CD33 and/or FLT3 CAR) or SENTI-202 (i.e., with the aCAR and the EMCN-recognizing iCAR).

Preclinical data also demonstrated identical killing activity of the leukemia cells with both CAR-NKs and significant selective protection of healthy HSC when exposed to SENTI-202 demonstrating in vitro protection of healthy cells from our proprietary EMCN targeting NOT gate.

In preclinical studies, 1:1:1 ratio of effector cells were injected with model leukemia cells that expressed CD33 and FLT3 target antigens, and model “healthy” cells that expressed CD33, FLT3 and the protective EMCN antigen.

The three effector cells used in this experiment were either non-engineered NK cells, CAR-NK cells with just the CD33 and/or FLT3 aCAR, and SENTI-202.

Results demonstrated that in the SENTI-202 group, leukemia cells were selectively killed while the model “healthy” cells were spared after greater than 3 weeks in vivo .

In the other two groups, there was non-selective killing of both the leukemia and the “healthy” cells.

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.

Development Plan and Key Next Steps for SENTI-202

In December 2023, our IND application for evaluation of SENTI-202 in patients with hematologic malignancies was cleared by the FDA, and we expect to start dosing patients in a Phase 1 clinical trial in the second quarter of 2024.

In December 2023, our IND application for evaluation of SENTI-202 in patients with hematologic malignancies was cleared by the FDA, and we began dosing patients in an open-label Phase 1 clinical trial in the United States and Australia in the second quarter of 2024.

Our Phase 1 clinical trial aims to evaluate SENTI-202 in patients with relapsed/refractory CD33 and/or FLT3 positive hematologic malignancies including AML.

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• Disease-specific lymphodepletion (“LD”) :

We plan to administer three doses of SENTI-202 following a disease-specific LD regimen known as fludarabine (flu) and cytarabine (ara-C), or flu/ara-C.

We plan to administer three-to-five doses of SENTI-202 following a disease-specific LD regimen known as fludarabine (flu) and cytarabine (ara-C), or flu/ara-C.

The use of flu/ara-C is an NCCN Category 2a chemotherapy regimen for patients with relapse-refractory AML.

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• Multi-dose and multi-cycle administration :

The starting dose of SENTI-202, as approved by the FDA in our IND, will be 1 billion CAR-NK cells.

The Phase 1 study will evaluate three doses of 1 billion CAR-NK cells, each dose administered a week apart, after LD, followed by bone marrow assessment at the end of the 4 th week (and these 4 weeks make up one cycle).

The SENTI-202 Phase 1 study is evaluating two dose levels (1 billion and 1.5 billion CAR+ NK cells per dose) administered after LD in either a three dose regimen (Schedule 1:

Days 0, 7, 14) or a five dose regimen (Schedule 2:

Days 0, 3, 7, 10, 14), followed by bone marrow assessment at the end of the fourth week (and these four weeks make up one cycle).

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

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

The study will evaluate both 1 billion and 1.5 billion CAR-NK cell doses and evaluate efficacy and pharmacodynamic markers in addition to standard Phase 1 objectives of safety, pharmacokinetics and dose finding.

The study will evaluate efficacy, pharmacodynamics and cytometry by Time-Of-Flight markers in addition to standard Phase 1 objectives of safety, pharmacokinetics and dose finding.

• Adaptive design and seamless transition to pivotal :

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

Our product program SENTI-301A is a multi-armed off-the-shelf healthy donor derived CAR-NK cell therapy designed for the treatment of advanced GPC3 positive tumors.

In partnership with Celest Therapeutics, a product candidate for the SENTI-301A program is in clinical development in China in patients with hepatocellular carcinoma (“HCC”).

We anticipate that Celest Therapeutics will begin dosing patients with product candidate SENTI-301A in the second quarter of 2024.

This program requires engineering NK cells with 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.

SENTI-301A 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.

The cell source for SENTI-301A is peripheral blood NK cells.

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

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:

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

Globally, it is the sixth most diagnosed cancer, and the fourth leading cause of cancer deaths.

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.

Frequently, HCC develops in patients with liver disease such as chronic hepatitis B or C virus, alcoholic liver disease or non-alcoholic steatohepatitis.

In China, where we have partnered with Celest Therapeutics, there were approximately 400,000 new cases of HCC in 2020, accounting for approximately 65% of worldwide liver cancer diagnoses.

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.

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SENTI-301A Approach to Advanced HCC

SENTI-301A off-the-shelf NK cells are engineered to incorporate multiple anti-tumor activities to achieve a multi-armed attack on solid tumors.

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

Specifically, SENTI-301A includes:

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

GPC3 is also a histologic and serum clinical marker for HCC and its expression has been associated with poor prognosis.

Functionally, GPC3 is associated with the control of cell division and growth regulation.

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.

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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 SENTI-301A

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

Through this collaboration, Celest Therapeutics will lead clinical development, operations, and manufacturing for the advancement of product candidate SENTI-301A with technical support from Senti.

Celest Therapeutics plans to enroll patients initially through a pilot trial in mainland China and expects to enroll the first patient in the second quarter of 2024.

Celest Therapeutics and Senti have the option to expand clinical development of SENTI-301A to Hong Kong, Macau and Taiwan.

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 pilot study aims to evaluate the product candidate SENTI-301A in patients with GPC3 positive advanced HCC in China.

Key features of the study design include:

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 3 doses of product candidate SENTI-301A following fludarabine/cyclophosphamide lymphodepletion which has been widely used to support the expansion of NK cells in prior clinical trials.

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 starting dose of product candidate SENTI-301A will be 1 billion CAR NK cells.

The pilot study will evaluate three doses of 1 billion CAR-NK cells each.

Each individual dose will be administered one week after LD.

After treatment, at the end of the fourth week, tumor response assessment will be performed utilizing imaging and biomarkers.

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 2 dose levels of cells and evaluate efficacy and pharmacodynamic markers in addition to standard Phase 1 objectives of safety, pharmacokinetics and dose finding.

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

Our preferred cell source for SENTI-202 and SENTI-301A, our off-the-shelf CAR-NK cell product programs, is peripheral blood NK cells because it allows us to immediately leverage an established supply chain, a mature GMP process, and extensive clinical experience to develop our next generation CAR-NK cell therapies as described below.

Natural killer (“NK”) cells are an integral part of the innate immune system and comprise 5 to 20% of circulating lymphocytes.

Our preferred cell source for SENTI-202, our off-the-shelf CAR-NK cell therapy program, is peripheral blood NK cells because it allows us to immediately leverage an established supply chain, a mature GMP process, and extensive clinical experience to develop our next generation CAR-NK cell therapies as described below.

Natural killer cells are an integral part of the innate immune system and comprise 5 to 20% of circulating lymphocytes.

They play a key immune surveillance role by recognizing and killing malignantly or virally transformed cells by directed release of lytic granules or by inducing death receptor-mediated apoptosis.

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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:

(“CAR”) T cell-like adverse events such as cytokine release syndrome (“CRS”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”),

• 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”),

• Lack of a T cell receptor (“TCR”) in NK cells have shown to result in inability to initiate graft-versus-host disease (GvHD), enabling NK cells to be used in allogeneic therapies without need for additional genetic manipulation, and

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Over 900 patients have safely received NK cell-based therapies since 2005.

This includes over 800 patients across more than 30 single institution academic studies who received non-engineered allogeneic NK cell therapy, the majority from healthy adult donors, and nearly 100 patients who have received CAR NK cells via single and multi-center early phase trials.

NK cell products are generally well tolerated and show clinical efficacy as a stand-alone treatment, with 20-60% CR rate on average across a wide variety of oncological conditions, including in patients with AML.

This includes over 800 patients across more than 30 single institution academic studies who received non-engineered allogeneic NK cell therapy, the majority from healthy adult donors, and 150+ patients who have received CAR NK cells via single and multi-center early phase trials.

NK and CAR NK cell products are generally well tolerated and show clinical efficacy as a stand-alone treatment, with 20-60% CR rate on average across a wide variety of oncological conditions, including in patients with AML.

This clinical activity was enhanced under several different conditions:

1) when the NK cells had been engineered with CARs.

2) cultured with cytokines.

3) after ‘activation’ by co-culturing with K562 cell lines (themselves modified to express cytokines), 4) when NK cell doses increased, and 5) for AML patients when fludarabine/ara-C (flu/ara-C) LD was used as lymphodepleting conditioning.

(1) when the NK cells had been engineered with CARs, (2) cultured with cytokines, (3) after ‘activation’ by co-culturing with K562 cell lines (themselves modified to express cytokines), (4) when NK cell doses increased, and (5) for AML patients when fludarabine/ara-C (flu/ara-C) LD was used as lymphodepleting conditioning.

Key limitations of the clinical experience with NK cells in AML patients include limited persistence of the infused cells, short durability of the observed responses, and immune evasion of LSCs.

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These technologies can be categorized as follows:

Multi-Arming:

Multi-Arming gene circuits are designed to incorporate multiple payloads into a single cell or gene therapy product.

These gene circuits are intended to activate various biological pathways in complementary ways to prevent diseases from evading single-target treatments, and thereby potentially improve treatment efficacy.

Existing combination therapies that target complex diseases require the application of multiple individual drugs, which is difficult due to research, clinical development, regulatory and pharmacology barriers.

Logic Gating:

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Generally, current medicines are unable to address more than one target at a time and are thus susceptible to tumor evasion.

Multi-Arming:

Multi-Arming gene circuits are designed to incorporate multiple payloads into a single cell or gene therapy product.

Regulator Dial:

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Manufacturing

In August 2023, we announced the sale of our manufacturing assets and a sublease of our 92,000 square foot manufacturing facility to a private equity group, Celadon Partners, 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 are 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 prepayment owed by us for manufacturing and research activities to GeneFab.

The remaining consideration of $18.9 million will be received in installments during 2024 and 2025, subject to satisfaction of certain conditions.

In August 2023, we announced the sale of our manufacturing assets and a sublease of our 92,000 square foot manufacturing facility to Valere Bio, Inc.

(“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.

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.

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.

Refer to 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, for additional details regarding the PIPE transaction.

The transaction has allowed us to focus on advancing our oncology programs into the clinic.

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Exclusive/Co-Exclusive Patent License Agreement with the National Cancer Institute for FLT3 Technology

In July 2020, we entered into an Exclusive/Co-Exclusive Patent License Agreement, as amended, or the 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.

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

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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Exclusive Patent License Agreement with the National Cancer Institute for CD33 Technology

In May 2021, we entered into an Exclusive Patent License Agreement, or the 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.

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.

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

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.

Pursuant to the NCI CD33 Agreement, we must use commercially reasonable efforts to adhere to a commercial development plan, including by achieving certain specified development and regulatory milestones by certain dates, provided that we may request to extend the timelines of such milestones, which the NCI shall not unreasonably deny if the request is supported by a reasonable showing of our diligent performance under the commercial development plan.

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Research Collaboration and License Agreement with Spark Therapeutics, Inc.

In April 2021, we entered into a Research Collaboration and License Agreement, or the Spark Agreement, with Spark Therapeutics.

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.

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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.

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

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.

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If Spark Therapeutics exercises an option for a particular promoter profile, it will be required to pay us an option exercise fee in the low to mid-single digit millions.

For each licensed promoter-containing in vivo gene therapy product, or licensed product, developed and commercialized by Spark Therapeutics or its affiliates or sublicensees, we are eligible to receive development, regulatory and commercialization milestone payments from Spark Therapeutics up to an aggregate dollar amount in the mid teens millions, and sales milestone payments from Spark Therapeutics up to an aggregate dollar amount in the low hundred millions.

For each licensed promoter-containing in vivo gene therapy product, or licensed product, developed and commercialized by Spark Therapeutics or its affiliates or sublicensees, we are eligible to receive development, regulatory and commercialization milestone payments from Spark Therapeutics up to an aggregate dollar amount in the tens of millions, and sales milestone payments from Spark Therapeutics up to an aggregate dollar amount in the low hundred millions.

In total, we are potentially eligible to receive upfront, opt-in and milestone payments exceeding $645 million if Spark Therapeutics exercises its options for all five promoter profiles and Spark Therapeutics, its affiliates and its sublicensees successfully develop and commercialize five licensed products;

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Further, Spark Therapeutics will be obligated to pay us royalties in the low-single digits percentage on net sales of each licensed product sold by Spark Therapeutics, its affiliates and its sublicensees, subject to specified reductions and offsets.

Spark Therapeutics’s obligation to pay royalties to us will expire for each licensed product when certain licensed patents and regulatory exclusivities have expired in the country of sale and a minimum number of years has elapsed since the first commercial sale of such licensed product in such country.

Spark Therapeutics’ obligation to pay royalties to us will expire for each licensed product when certain licensed patents and regulatory exclusivities have expired in the country of sale and a minimum number of years has elapsed since the first commercial sale of such licensed product in such country.

The Spark Agreement will expire at the end of the last evaluation period if Spark Therapeutics does not exercise any of its options.

If Spark Therapeutics exercises at least one option, then the Spark Agreement will expire, on a licensed product-by- licensed product and country-by-country basis, upon the expiration of Spark Therapeutics’s royalty obligation for such licensed product in such country.

If Spark Therapeutics exercises at least one option, then the Spark Agreement will expire, on a licensed product-by- licensed product and country-by-country basis, upon the expiration of Spark Therapeutics’ royalty obligation for such licensed product in such country.

Spark Therapeutics may terminate the Spark Agreement in its entirety, or on a promoter profile-by-promoter profile or licensed promoter-by-licensed promoter basis, following a specified notice period.

Either party may terminate the Spark Agreement in its entirety or in part if the other party fails to cure its material breach of the Spark Agreement within a specified cure period, or immediately if the other party becomes bankrupt or insolvent.

We may terminate the Spark Agreement if Spark Therapeutics or any of its affiliates commences any action challenging the validity or enforceability of the licensed patents, other than in certain specified circumstances, or if Spark Therapeutics’s sublicensee challenges our licensed patents, under certain specified circumstances.

We may terminate the Spark Agreement if Spark Therapeutics or any of its affiliates commences any action challenging the validity or enforceability of the licensed patents, other than in certain specified circumstances, or if Spark Therapeutics’ sublicensee challenges our licensed patents, under certain specified circumstances.

Collaboration and Option Agreement with BlueRock Therapeutics LP

In May 2021, we entered into a Collaboration and Option Agreement, or the BlueRock Agreement, with BlueRock Therapeutics LP, or BlueRock.

In May 2021, we entered into a Collaboration and Option Agreement (“BlueRock Agreement”), with BlueRock Therapeutics LP (“BlueRock”).

BlueRock is a wholly-owned subsidiary of Bayer Healthcare LLC.

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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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We have granted to BlueRock an option, on a collaboration program-by-collaboration program basis, to obtain an exclusive or non-exclusive license under our intellectual property rights to develop, manufacture and commercialize, for the prevention, treatment or palliation of specified indications, or a licensed field, cell therapy products that contain cells of specified types that incorporate an option gene circuit from such collaboration program or a closely related derivative gene circuit.

For each collaboration program, BlueRock may conduct evaluation activities on the option gene circuits from such collaboration program to determine whether to exercise its option, and BlueRock may exercise its option to such option gene circuits together with certain closely related derivative gene circuits, or licensed gene circuits, prior to the expiration of a certain time period, or the option exercise period, which includes a minimum amount of time after the expiration of the three-year research term, delivery of a data package to BlueRock, and completion of a transfer of technology to enable BlueRock’s evaluation activities, whichever happens last.

For each collaboration program, BlueRock may conduct evaluation activities on the option gene circuits from such collaboration program to determine whether to exercise its option, and BlueRock may exercise its option to such option gene circuits together with certain closely related derivative gene circuits, or licensed gene circuits, prior to the expiration of a certain time period (the “option exercise period”), which includes a minimum amount of time after the expiration of the three-year research term, delivery of a data package to BlueRock, and completion of a transfer of technology to enable BlueRock’s evaluation activities, whichever happens last.

If BlueRock exercises its option for a collaboration program, the parties shall negotiate the financial terms, which will be within certain pre-agreed parameters and may be determined by baseball arbitration if the parties do not reach agreement within the specified negotiation period, and enter into an otherwise agreed-upon written license agreement, or a commercial license.

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If BlueRock exercises its option and the parties enter into a commercial license, then it will end a certain amount of time after the later of completion of research activities or execution of the commercial license.

In addition to the option described above, we granted a right of first negotiation to BlueRock, on a collaboration program-by-collaboration program basis, to obtain a license under our intellectual property rights to research, develop, manufacture and commercialize, for the prevention, treatment or palliation of a specified disease area, or the negotiation field, cell therapy products containing cells of a specified type, or the negotiation cells, that incorporate an applicable efficacy gene circuit developed under such collaboration program.

In addition to the option described above, we granted a right of first negotiation to BlueRock, on a collaboration program-by-collaboration program basis, to obtain a license under our intellectual property rights to research, develop, manufacture and commercialize, for the prevention, treatment or palliation of a specified disease area (the “negotiation field”), cell therapy products containing cells of a specified type (“negotiation cells”), that incorporate an applicable efficacy gene circuit developed under such collaboration program.

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.

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.

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.

terminate the BlueRock Agreement in its entirety, or on a collaboration program-by-collaboration program basis, following a specified notice period.

BlueRock may terminate the BlueRock Agreement in its entirety, or on a collaboration program-by-collaboration program basis, following a specified notice period.

Either party may terminate the BlueRock Agreement if the other party fails to cure its material breach of the BlueRock Agreement within a specified cure period, or immediately if the other party becomes bankrupt or insolvent.

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Exclusive Patent License Agreement with the National Cancer Institute for GPC3 Technology

In February 2021, we entered into an Exclusive Patent License Agreement, or the NCI GPC3 Agreement, with the U.S.

In February 2021, we entered into an Exclusive Patent License Agreement (“NCI GPC3 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 glypican-3, or GPC3, 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, production and commercialization of a monospecific CAR-based immunotherapy for the prophylaxis and treatment of GPC3 expressing human cancers using unmodified, off-the-shelf natural killer cells transduced with a viral vector that expresses a CAR, and a gene circuit regulating the expression of one or more armoring payloads, specifically excluding the use of autologous T cells or T cells that have been genetically modified to become off-the-shelf.

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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.

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

In August 2023, we completed a transaction with GeneFab, a contract manufacturing and synthetic biology biofoundry focused on next-generation cell and gene therapies.

Under a framework agreement entered into by us and GeneFab, we sold, assigned and transferred rights, title and interest in certain of our assets and contractual rights, including all of our equipment at our facilities in Alameda and certain of our intellectual property related to the schematics for and design of the Alameda facility.

We subleased our recently constructed 92,000 square foot current good manufacturing practice facility in Alameda, California to GeneFab which will support the clinical manufacturing of our CAR-NK programs, including SENTI-202.

The transaction provided us with additional capital in the form of a note receivable and rights to future manufacturing and research activities and reduced longer term operating expenses.

In connection with the transaction, we are entitled to receive total consideration of $37.8 million before the end of 2025, of which $18.9 million was payable at closing and was netted against prepayment owed by us for manufacturing and research activities to GeneFab under a development and manufacturing services agreement that was separately entered into by us and GeneFab as part of the transaction.

The remaining $18.9 million will be paid to us in installments in 2024 and 2025, subject to satisfaction of certain conditions.

The Company determined that the $18.9 million for future manufacturing and research activities, inclusive of the volume discount provided, was executed at market terms and does not result in any impact to the total consideration received from GeneFab for the disposal of the business.

We also agreed to grant a license to GeneFab under certain of our intellectual property rights to conduct manufacturing services and to research, develop, manufacture and commercialize products outside of oncology, pursuant to a license agreement that is still under negotiation as of March 2024.

GeneFab was provided an option to purchase up to 19,633,444 shares (i.e.

up to $20.0 million worth) of our common stock at an exercise price of $1.01867, or the GeneFab Option.

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.

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”).

Donald Tang, a member of our Board of Directors appointed in December 2024, is a manager of Celadon Partners.

Pursuant to the Framework Agreement, we sold the Purchased Assets, and consummated, or will consummate, the other transactions contemplated thereby, for total consideration of $37.8 million in cash.

Fifty percent of the Cash Consideration, or $18.9 million, was paid at closing and the parties waived payment of the remaining $18.9 million in connection with Celadon’s investment in the private placement in December 2024 as described in Part II - Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operation - Recent Developments of this Annual Report on Form 10-K.

GeneFab was also provided an option (which was subsequently assigned to Celadon Partners) to purchase up to 1,963,344 shares (i.e., up to $20.0 million worth) of our common stock at an exercise price of $10.18670, or the GeneFab Option.

The GeneFab Option is exercisable upon the execution of the License Agreement, no later than August 7, 2026.

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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 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.

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

In November 2023, we entered into a Collaboration and Option Agreement, or the Celest Agreement, with Celest Therapeutics.

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 program in mainland China with certain technical support from us.

In November 2023, we entered into a Collaboration and Option Agreement (the “Celest Agreement”), with Celest Therapeutics.

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 Therapeutics may exercise its option prior to the expiration of a certain time period, or 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.

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 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, or 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.

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

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.

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Our general strategy includes protecting our proprietary technology and intellectual property rights domestically and in certain key foreign markets.

We continually grow and supplement our intellectual property portfolio with new filings and

applications not only to strengthen the protection of proprietary technology and intellectual property rights, but also to protect and support the development and commercialization of current and future product candidates.

We continually grow and supplement our intellectual property portfolio with new filings and applications not only to strengthen the protection of proprietary technology and intellectual property rights, but also to protect and support the development and commercialization of current and future product candidates.

In addition, we seek to protect our technological innovations and branding efforts by filing new patent and trademark applications at the appropriate time and in strategically relevant jurisdictions.

Our patent portfolio relates to our ongoing research and development activities and includes a combination of patents and pending patent applications licensed from third parties, pending patent applications jointly owned with third parties, and patent applications solely owned by us.

Our patent portfolio relates to our ongoing research and development activities and includes a combination of patents and pending patent applications licensed from third parties, jointly owned with third parties, and solely owned by us.

The patents and pending patent applications in our portfolio can be categorized as relating to our gene circuit platform technologies, including Logic Gating gene circuits, Multi-Arming gene circuits, Regulator Dial gene circuits and Smart Sensor gene circuits;

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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 February 16, 2024, our in-licensed and owned patent portfolio consists of over 11 issued patents and 234 pending patent applications, of which we own or co-own 5 patents and 212 pending patent applications, and have licensed 6 patents and 22 pending patent applications.

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.

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 February 16, 2024, we own two United States trademark registrations, four pending and/or allowed United States trademark applications, and five foreign trademark registrations.

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.

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.

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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The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial.

In such a case, the IND may be

placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin.

In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin.

Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

In addition to the submission of an IND to the FDA before initiation of a clinical trial in the United States, certain human clinical trials involving recombinant or synthetic nucleic acid molecules are subject to oversight of institutional biosafety committees, or IBCs, as set forth in the National Institutes of Health, or NIH, Guidelines for Research Involving Recombinant DNA Molecules, or the NIH Guidelines.

Specifically, under the NIH Guidelines, supervision of human gene transfer trials includes evaluation and assessment by an IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution.

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• Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to

establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of a BLA.

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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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An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions.

The FDA is not

bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured.

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For example, new biological products are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation applies to the combination of the product and the specific indication for which it is

being studied.

Fast track designation applies to the combination of the product and the specific indication for which it is being studied.

The sponsor of a new biologic may request that the FDA designate the biologic as a fast track product at any time during the clinical development of the product.

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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 exceptions;

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

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RMAT designation provides all the benefits of breakthrough therapy designation, including more frequent meetings with the FDA to discuss the development plan for the product candidate and eligibility for rolling review and priority review.

Product candidates granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to

predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of clinical trial sites, including through expansion of trials to additional sites.

Product candidates granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of clinical trial sites, including through expansion of trials to additional sites.

RMAT-designated products that receive accelerated approval may, as appropriate, fulfill their post-approval requirements through submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence (such as electronic health records);

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There also are continuing, annual program fees for any marketed products.

Biologic manufacturers and other entities involved in the manufacture and distribution of approved biological products, and those supplying products, ingredients, and

components of them, are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.

Biologic manufacturers and other entities involved in the manufacture and distribution of approved biological products, and those supplying products, ingredients, and components of them, are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.

Manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States.

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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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The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies from engaging in off-label promotion.

The FDA and other regulatory agencies have also required that companies enter into consent

decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.

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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.

than nine months of term remaining.

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

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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.

A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

There can be no

assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.

Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.

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• The Budget Control Act of 2011 and subsequent legislation, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of 2% per fiscal year, which remain in effect through 2031.

Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation.

The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

• On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law.

however, legislation has been introduced in the U.S.

Congress that would, if enacted, reverse these payment reductions.

In addition to provider payment cuts under Medicare, the American Rescue Plan Act of 2021 also eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

• On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.

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Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S.

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;

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The effects of the IRA on our business and the healthcare industry in general is not yet known.

In addition, President Biden has issued multiple executive orders that have sought to reduce prescription drug costs.

In addition, in February 2023, HHS issued a proposal in response to an October 2022 executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through FDA’s accelerated approval pathway.

Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

At a federal level, President Trump reversed some of President Biden’s executive orders including rescinding Executive Order 14087 entitled “Lowering Prescription Drug Costs for Americans.” President Trump may issue new executive orders designed to impact drug pricing.

President Trump has also implemented workforce reduction/cost saving measures which may impact our FDA review timelines.

A number of these and other proposed measures may require authorization through additional legislation to become effective.

Congress and the Trump administration have indicated that they will continue to seek new legislative measures to control drug costs.

There has also been heightened governmental scrutiny recently over the manner in which manufacturers set prices for their marketed products.

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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.

arrangements and relationships through which we market, sell and distribute our 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.

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-U.S.

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

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.

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;

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.

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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The collection and processing of personal data (including health data) in the European Economic Area, or EEA and the United Kingdom, or UK is governed by the EU General Data Protection Regulation, or EU GDPR (with regards to the EEA) and the UK General Data Protection Regulation, or UK GDPR (with respect to the UK), as well as applicable data protection laws in effect in the Member States of the EEA and in the UK (including the UK Data Protection Act 2018).

The EU and UK data protection regimes are independent of each other but remain largely

The EU and UK data protection regimes are independent of each other but remain largely aligned.

However, the UK Government has introduced a Data Protection and Digital Information Bill, or Data Reform Bill into the UK legislative process to reform the UK data protection legal framework.

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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-seven percent (77%) are people of color and approximately forty-six percent (46%) 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 also subleased our 92,000 square feet of manufacturing space under a sublease agreement to GeneFab that was executed in August 2023.

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 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.

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.

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

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Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company if (1) the market value

of our common stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter are less than $100 million and the market value of our common stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.

We will remain a smaller reporting company if (1) the market value of our common stock held by non-affiliates is less than $250 million as of the last business day of the second fiscal quarter, or (2) our annual revenues in our most recent fiscal year completed before the last business day of our second fiscal quarter are less than $100 million and the market value of our common stock held by non-affiliates is less than $700 million as of the last business day of the second fiscal quarter.

Corporate Information

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Available Information

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments to these reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, are available free of charge on our website located at www.sentibio.com as soon as reasonably practicable after they are filed with or furnished to the Securities and Exchange Commission, or the SEC.

The SEC maintains an Internet website that contains reports, proxy and information statements, and other information regarding us and other issuers that file electronically with the SEC.

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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