On December 13, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative pharmacology, biomarker, and data platforms, reported its financial results for its second quarter of fiscal 2022, ended October 31, 2021 (Press release, Champions Oncology, DEC 13, 2021, View Source [SID1234597042]).

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Second Quarter and Recent Highlights:

•Record quarterly revenue of $11.8 million, an increase of 17% year over year
•Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $743,000
•Gross margin improved to 52%

Ronnie Morris, CEO of Champions, commented, "We had another quarter of milestone achievements for the Company as we saw strong operating results in our research service business and continued to expand the customer base of our SaaS Lumin platform." Morris added, "We’re advancing our therapeutic targets along the drug discovery pipeline and we’re excited about their progress and transformative potential for Champions."

David Miller, CFO of Champions, said, "We achieved another quarterly revenue record reaching $11.8 million. Additionally, by improving efficiencies and reducing certain costs, we improved our gross and operating margins all while continuing to increase R&D investment to support longer term strategic initiatives."

Second Fiscal Quarter Financial Results

Exhibit 99.1
For the second quarter of fiscal 2022, revenue increased 17% to $11.8 million compared to $10.1 million for the second quarter of fiscal 2021. The increase in revenue was due to continued demand for our pharmacology studies and the expansion of both our platform and product lines, driving an increase in sales, both in number and size of studies. Total costs and operating expenses for the second quarter of fiscal 2022 were $11.5 million compared to $10.1 million for the second quarter of fiscal 2021, an increase of $1.4 million or 14.0%.

For the second quarter of fiscal 2022, Champions reported net income from operations of $263,000, including $134,000 in stock-based compensation and $346,000 in depreciation and amortization expenses, compared to income from operations of $7,000, inclusive of $85,000 in stock-based compensation and $307,000 in depreciation and amortization expenses, in the second quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $743,000 for the second quarter of fiscal 2022 compared to non-GAAP income from operations of $399,000 in the second quarter of fiscal 2021.
Cost of oncology solutions was $5.6 million for the three-months ended October 31, 2021, a decrease of $35,000, or (0.6)% compared to $5.6 million for the three-months ended October 31, 2020. For the three-months ended October 31, 2021, gross margin was 52.4% compared to 44.2% for the three-months ended October 31, 2020. Total cost of sales remained flat as we reduced the level of outsourcing required. The cost reduction more than offset the increase in compensation and lab supply expenses resulting from the increase in study volume.

Research and development expense for the three-months ended October 31, 2021 was $2.3 million, an increase of $649,000 or 39.3%, compared to $1.7 million for the three-months ended October 31, 2020. The increase was primarily from compensation and sequencing costs as we increased investment in our therapeutic target discovery platform. Sales and marketing expense for the three-months ended October 31, 2021 was $1.6 million, an increase of $292,000, or 21.7%, compared to $1.3 million for the three-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment to expand our salesforce, including the addition of a dedicated SaaS business development team for our Lumin Bioinformatics platform. General and administrative expense for the three-months ended October 31, 2021 was $2.0 million, an increase of $507,000, or 34.5%, compared to $1.5 million for the three-months ended October 31, 2020. The increase was primarily due to an increase in compensation and IT related expenses.

Net cash generated from operating activities for the quarter was $1.2 million resulting from increased operating income excluding stock compensation and other non-cash related expenses. Net cash used in investing activities was $495,000 primarily from investment in additional lab equipment and software development. The Company ended the quarter with a strong cash position of $4.8 million. The Company has no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2022, revenue increased 17% to $23.0 million compared to $19.7 million for the first six months of fiscal 2021. The increase in revenue was due to the expansion of our platforms and business lines. Total costs and operating expenses for the first six months of fiscal 2022 were $23.0 million compared to $19.6 million for the first six months of fiscal 2021, an increase of $3.3 million or 17%.

Exhibit 99.1
For the first six months of fiscal 2022, Champions reported net income from operations of $88,000, including $414,000 in stock-based compensation and 663,000 in depreciation and amortization expenses, compared to income from operations of $31,000, inclusive of $205,000 in stock-based compensation and $584,000 in depreciation and amortization expenses, in the first six months of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $1.2 million for the first six months of fiscal 2022 compared to non-GAAP income from operations of $822,000 in the first six months of fiscal 2021.
Cost of oncology solutions was $11.0 million for the six-months ended October 31, 2021, a slight increase of $25,000, or 0.2% compared to $11.0 million for the six-months ended October 31, 2020. For the six-months ended October 31, 2021, gross margin was 52.2% compared to 44.2% for the six-months ended October 31, 2020. The improvement in gross margin was primarily attributable to decreasing the Company’s reliance on outsourcing while continuing to grow revenue.

Research and development expense for the six-months ended October 31, 2021 was $4.6 million, an increase of $1.4 million or 41.8%, compared to $3.2 million for the six-months ended October 31, 2020. The increase was primarily from compensation, sequencing costs, and lab supplies as we increased investment in our therapeutic target discovery platforms. Sales and marketing expense for the six-months ended October 31, 2021 was $3.2 million, an increase of $658,000, or 25.7%, compared to $2.6 million for the six-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development teams. General and administrative expense for the six-months ended October 31, 2021 was $4.1 million, an increase of $1.3 million, or 44.9%, compared to $2.9 million for the six-months ended October 31, 2020. The increase was primarily due to an increase in compensation as well as an increase in IT related expenses to support the overall infrastructure growth of the organization.

Net cash provided by operating activities was $1.4 million for the six-months ended October 31, 2021.The cash generated from operating activities was primarily due to operating income excluding stock compensation, depreciation and amortization expenses. Net cash used in investing activities was $1.5 million and was primarily from investment in additional lab equipment and software development.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 877-545-0320 (Domestic) or 973-528-0002 (International) and enter the access code 694190 ten minutes ahead of the call.
Full details of the Company’s financial results will be available by Tuesday, December 14, 2021 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information
See the attached Reconciliation of GAAP net income to Non-GAAP net income for an explanation of the amounts excluded to arrive at Non-GAAP net income and related Non-GAAP earnings per share amounts for the three and six months ended October 31, 2021 and 2020. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income and Non-GAAP earnings per share are not, and should not, be viewed as

Exhibit 99.1
a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings per share amounts as Non-GAAP net earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings and Non-GAAP diluted earnings per share may differ from similarly named measures used by other companies.

On December 13, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Bristol Myers Squibb (NYSE: BMY), reported that they have entered into a license, development and commercialization agreement (the "agreement") for Immatics’ TCR Bispecific candidate, IMA401 (Press release, FierceBiotech, DEC 13, 2021, View Source [SID1234597041]).

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Under the terms of the agreement, Immatics will receive an upfront payment of $150 million as well as up to $770 million in development, regulatory and commercial milestone payments, in addition to tiered double-digit royalty payments on net sales of IMA401. Immatics retains the options to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the US.

IMA401 is the most advanced product candidate in Immatics’ TCR Bispecifics pipeline, called TCER (T Cell Engaging Receptors), in which one binding region targets MAGEA4/8, a highly prevalent antigen in multiple solid tumors, and the other region engages and activates T cells. In preclinical proof-of-concept studies, IMA401 has shown anti-tumor activity with complete remissions in various in vivo tumor models including patient-derived xenograft models. The agreement outlines a development plan under which both companies will collaborate to advance the program through clinical development.

In November 2021, Immatics filed a Clinical Trial Application (CTA)1 with Paul-Ehrlich-Institute (PEI), the German federal regulatory authority, for the development of IMA401. The clinical trial, which is planned to commence in the first half of 2022, will enroll patients across various solid tumor types.

"At Immatics, we are committed to our goal of delivering meaningful clinical benefits to cancer patients, and based on the promising preclinical data, we see remarkable potential for our TCER platform" said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We are delighted to extend our existing collaboration with Bristol Myers Squibb to the IMA401 program and view this as an important validation of the therapeutic potential of our TCER approach. Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology make them the ideal partner for the further development of IMA401."

"We are pleased to expand our collaboration with Immatics to now include IMA401," said Teri Foy, Senior Vice President, Research and Early Development, Immuno-Oncology and Cell Therapy at Bristol Myers Squibb. "TCERs are an important, emerging modality for solid tumors with the potential for cell therapy-like efficacy in an off-the-shelf platform offering potentially broader patient access. We look forward to advancing IMA401 into the clinic to further assess its potential as an innovative medicine to help patients prevail over serious diseases."

Immatics entered a strategic collaboration in 2019 with Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company, to develop novel adoptive cell therapies. This new collaboration to develop Immatics’ Bispecific candidate TCER IMA401 complements ongoing cell therapy activities – both therapeutic modalities built on Immatics’ capabilities to identify novel targets and develop high-affinity, target-specific TCRs. The terms of the current agreement regarding Immatics’ TCER IMA401 program exclude any MAGEA4/8 targets for cell therapy. The agreement is subject to customary clearance by antitrust regulators.

1 Clinical Trial Application – the European equivalent of an Investigational New Drug (IND) application

About IMA401
IMA401 is Immatics’ half-life extended TCER molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). MAGEA4/8 is highly prevalent in several solid tumor types including squamous non-small-cell lung carcinoma, head and neck squamous cell carcinoma, bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by an HLA molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.

On December 13, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance reported that preclinical data with ORIC’s small molecule inhibitor of CD73 in multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper), in collaboration with Dr. Kenneth Anderson’s research laboratory at Dana-Farber Cancer Institute (Press release, ORIC Pharmaceuticals, DEC 13, 2021, View Source [SID1234597018]). The abstract and presentation are available for online viewing via the ASH (Free ASH Whitepaper) Annual Meeting website.

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"ORIC-533 has a differentiated profile, demonstrating stronger potency in a high AMP environment compared to benchmark CD73 inhibitors and adenosine receptor antagonists in preclinical studies," said Lori Friedman, chief scientific officer. "Based on a strong mechanistic rationale and compelling single agent activity in patient-derived autologous ex vivo assays, we are excited to pursue clinical development in multiple myeloma."

Multiple myeloma patient samples have demonstrated that the tumor environment is adenosine rich, and studies have shown that high CD73 and adenosine levels are associated with poor prognosis and therapeutic resistance.

The ASH (Free ASH Whitepaper) presentation focused on the role of adenosine signaling in immunosuppression in patients with relapsed or refractory multiple myeloma and the ability of ORIC’s small molecule inhibitor of CD73 to restore antitumor immune activity.

Key highlights from a series of experiments utilizing bone marrow aspirates from patients with multiple myeloma include:

CD73 inhibition addressed adenosine mediated immunosuppression, which stimulated T-cell proliferation, T-cell activation, and activation of plasmacytoid dendritic cells in ex vivo assays derived from patients with multiple myeloma.
ORIC’s small molecule inhibitor of CD73 overcame immunosuppression and triggered significant lysis and cell death of multiple myeloma cells by autologous T-cells from the bone marrow microenvironment.
ORIC’s CD73 inhibitor demonstrated single agent activity, comparing favorably to standard of care therapies, in bone marrow-derived mononuclear cell assays from relapsed or refractory myeloma patients.
The company plans to pursue a single agent clinical development plan for ORIC-533 in multiple myeloma and initiate a Phase 1 trial in the fourth quarter of 2021.

Additional Pipeline Updates:

ORIC-114 EGFR/HER2 Inhibitor

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. The company recently disclosed that ORIC-114 induced tumor regressions in a subcutaneous HER2 positive breast cancer xenograft model. In a new study, ORIC-114 demonstrated significant tumor growth inhibition in an intracranial HER2 positive breast cancer model, with superior antitumor activity versus tucatinib. The CTA has been filed in South Korea, and initiation of a Phase 1 trial is expected in early 2022.

ORIC-944 PRC2 Inhibitor

ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. The IND was cleared by the FDA in December, and initiation of a Phase 1 trial is expected in early 2022.

Webcast and Conference Call Details

ORIC will host a conference call and webcast, today at 5:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 7989199. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

About ORIC-533

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, as well as other small molecule inhibitors of CD73 and adenosine receptor antagonists. Preclinical data demonstrated that ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment, reflective of AMP levels observed in tumors. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, as well as in ex vivo bone marrow aspirates from relapsed or refractory multiple myeloma patients.

On December 13, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported a trial in progress poster on NKX019 for the treatment of relapsed and refractory B-cell malignancies at the 63RD Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Nkarta, DEC 13, 2021, View Source [SID1234597017]).

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NKX019 is an allogeneic and off-the-shelf investigational NK cell therapy candidate that builds on the innate anti-cancer biology of NK cells and their positive safety profile. Using NK cells selected from healthy donors, NKX019 is engineered to express a chimeric antigen receptor (CAR) targeting the B-cell antigen CD19 and membrane-bound IL-15 to augment the activity of the NK cells.

"Nkarta is pleased to share the details of the ongoing NKX019 Phase 1 clinical trial and its innovative multi-dose and multi-cycle treatment regimen with the clinical community," said Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. "Our vision is to establish new standards in cell therapy, integrating the power of innate immunology and the unique benefits of an engineered, off-the-shelf product to transform cancer treatment. The NKX019 clinical trial continues to advance at sites in Australia and the US, and we look forward to reporting initial data in 2022."

The poster outlines the design of a Phase 1 clinical trial (NCT05020678) evaluating the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy in patients with B-cell malignancies that express CD19, a well-validated B-cell cancer target. The presentation also includes preclinical data that demonstrate NKX019 retains its anti-tumor activity against cancer cell lines that express very low levels of CD19.

Poster Title: A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects with B-Cell Malignancies
Presenter: Michael Dickinson, MBBS, DMed Sci, FRACP, FRCPA, Peter MacCallum Cancer Centre and Royal Melbourne Hospital
Session: 704. Cellular Immunotherapies: Clinical: Poster III
Date and Time: December 13, 2021, 6:00pm – 8:00pm ET
Publication Number: 3868

The poster is available on the ASH (Free ASH Whitepaper) website and on the Nkarta website here. Additional information about the clinical trial is available on ClinicalTrials.gov.

About B-Cell Cancers
B-cell lineage cancers are a worldwide healthcare burden. Over 500,000 new cases of non-Hodgkin lymphoma (NHL) and 50,000 new cases of acute lymphoblastic leukemia (ALL) are diagnosed worldwide each year (seer.cancer.gov, Smith 2015, Solomon 2017). Despite progress in treatment, many patients diagnosed with this heterogeneous group of cancers still succumb to their diseases. Autologous chimeric antigen receptor (CAR) T cells specific for CD19 have altered the treatment landscape for some patients with relapsed or refractory (r/r) B-cell malignancies, though significant toxicities associated with T-cell expansion and the necessity for bespoke manufacturing have limited their use.

About the NKX019-101 Clinical Trial
The NKX019-101 clinical trial is a Phase 1, multi-center, open-label, dose-finding and dose-expansion study to evaluate the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy. Patients with CAR T naïve relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B-cell acute lymphoblastic leukemia (B-ALL) will be enrolled in the dose-finding portion of the study. Following the selection of a recommended Phase 2 dose, patients with r/r aggressive or indolent NHL, B-ALL, or CLL, including patients whose disease progressed despite treatment with a CD19 CAR-T cell therapy, will be enrolled in the dose-expansion portion of the trial. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies.

On December 13, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported that positive interim Phase 1 data from the Company’s FT596 program for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Fate Therapeutics, DEC 13, 2021, View Source [SID1234597016]). FT596 is the Company’s off-the-shelf, multi-antigen targeted, iPSC-derived natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor that has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity.

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"The interim dose-escalation clinical data from our FT596 program in relapsed / refractory B-cell lymphoma demonstrate that off-the-shelf, iPSC-derived CAR NK cells can bring substantial therapeutic benefit to heavily pre-treated patients in urgent need of therapy, with high response rates and meaningful duration of responses," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are particularly pleased with the therapeutic profile that has emerged with FT596 in combination with rituximab, where over half of the patients treated with a single dose of FT596 at higher dose levels achieved a complete response with a favorable safety profile that is clearly differentiated from CAR T-cell therapy. We look forward to assessing a two-dose treatment schedule for FT596 to further define its potential best-in-class therapeutic profile and ability to reach more patients, including those earlier in care."

The ongoing Phase 1 study in relapsed / refractory BCL is assessing a single dose of FT596 as monotherapy (Monotherapy Arm) and in combination with a single dose of rituximab (375 mg/m2) (Combination Arm) following three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine). Certain patients are eligible for re-treatment with a second, single-dose cycle.

The ASH (Free ASH Whitepaper) presentation (Session 704—Cellular Immunotherapies: Expanding Targets and Cellular Sources for Immunotherapies, Abstract 823) includes clinical data from 25 evaluable patients for safety (n=12 in Monotherapy Arm; n=13 in Combination Arm) in the first, second, and third single-dose cohorts of 30 million, 90 million, and 300 million cells, respectively, of which 24 patients were also evaluable for efficacy (n=12 in Monotherapy Arm; n=12 in Combination Arm), as of the data cutoff date of October 11, 2021. These 25 patients had received a median of four prior lines of therapy and a median of two prior lines containing CD20-targeted therapy. Of the 25 patients, 15 patients (60%) had aggressive B-cell lymphoma, 15 patients (60%) were refractory to most recent prior therapy, and 8 patients (32%) were previously treated with autologous CD19-targeted CAR T-cell therapy. Subsequent to the data cutoff date for the ASH (Free ASH Whitepaper) presentation, an additional patient in the third single-dose cohort of the Combination Arm was evaluable for initial anti-tumor response, and seven patients in the fourth single-dose cohort of 900 million cells (n=1 in Monotherapy Arm; n=6 in Combination Arm) were evaluable for safety and initial anti-tumor response.

Single-dose, Single-cycle Response Data

In the second, third, and fourth dose cohorts of the Monotherapy and Combination Arms comprising a total of 26 patients, 18 patients (69%) achieved an objective response, including 12 patients (46%) that achieved a complete response, on Day 29 following a single dose of FT596 (see Table 1). Nine of these 26 patients were previously treated with autologous CD19-targeted CAR T-cell therapy and, of these nine patients, six achieved an objective response (67%) on Day 29 following a single dose of FT596. Notably, in the third and fourth dose cohorts of the Combination Arm comprising a total of 12 patients, nine patients (75%) achieved an objective response, including seven patients (58%) that achieved a complete response, on Day 29 following a single dose of FT596.

Durability of Response Data

The ASH (Free ASH Whitepaper) presentation includes durability of response data from 13 responding patients in the second and third single-dose cohorts of 90 million cells and 300 million cells (n=9 in Monotherapy Arm; n=10 in Combination Arm). As of the data cutoff date of October 11, 2021, 10 patients continued in ongoing response, including three patients in ongoing complete response at least six months from initiation of treatment; two patients reached six months in complete response and subsequently had disease progression; and one patient had disease progression prior to six months. Of these 13 responding patients:

Monotherapy Arm (n=7 responding patients). Five patients, all of whom were treated with a second FT596 single-dose cycle with the consent of the U.S. Food and Drug Administration (FDA), continued in ongoing response at a median follow-up of 4.1 months, including one patient in ongoing complete response at 8.1 months; one patient, who was treated with only one FT596 single-dose cycle, reached six months in complete response and subsequently had disease progression at 6.5 months; and one patient, who was treated with only one FT596 single-dose cycle, had disease progression at 1.7 months.
Combination Arm (n=6 responding patients). Five patients, all of whom were treated with a second FT596 single-dose cycle with the consent of the FDA, continued in ongoing response at a median follow-up of 4.6 months, including two patients in ongoing complete response at 6.0 and 10.8 months; and one patient, who was treated with a second FT596 single-dose cycle with the consent of the FDA, reached six months in complete response and subsequently had disease progression at 6.7 months.
Table 1. FT596 Interim Phase 1 Data – Day 29 Response Assessment 1
1 Dose x 1 Cycle Monotherapy
(n=13) Combination
(n=19)
Single-dose Level Cohorts (Cells) OR CR OR CR
30M 1/3 (33%) 0 0/3 (0%) 0
90M 3/4 (75%) 2 2/4 (50%) 2
300M 2 4/5 (80%) 1 4/6 (67%) 3
900M 2 0/1 (0%) 0 5/6 (83%) 4
aCD19 History (≥90M Cells) n=10 n=16
Naïve 7/9 (78%) 3 5/8 (63%) 4
Prior 0/1 (0%) 0 6/8 (75%) 5
Disease Histology (≥90M Cells) n=10 n=16
Aggressive 1/3 (33%) 0 6/11 (55%) 4
Mantle cell 0/1 (0%) 0 2/2 (100%) 2
Indolent 6/6 (100%) 3 3/3 (100%) 3
aCD19 = autologous CD19-targeted CAR T-cell therapy; Aggressive = diffuse large B-cell lymphoma, Grade 3b follicular lymphoma, Richter’s transformation, and high-grade B-cell lymphoma; CR = complete response; Indolent = splenic diffuse red pulp small B-cell lymphoma, non-Grade 3b follicular lymphoma, Waldenstrom’s macroglobulinemia, and small lymphocytic lymphoma; M = million; OR = objective response
1 As of data cutoff date of October 11, 2021, unless otherwise noted. Objective response and complete response are based on Cycle 1 Day 29 protocol-defined response assessment per Lugano 2014 criteria. Data subject to source document verification.
2 Cycle 1 Day 29 protocol-defined response assessment completed subsequent to data cutoff date for one patient in the third single-dose cohort of 300 million cells in the Combination Arm and seven patients in the fourth single-dose cohort of 900 million cells (n=1 in Monotherapy Arm; n=6 in Combination Arm).

Safety Data

The FT596 treatment regimens were well tolerated, including in those patients treated with a second, single-dose cycle. No dose-limiting toxicities, and no treatment-emergent adverse events (TEAEs) of any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD) were observed. Three low-grade adverse events (two Grade 1, one Grade 2) of cytokine release syndrome (CRS) were reported, which were of limited duration and resolved without intensive care treatment (see Table 2).

The Company has initiated enrollment of a two-dose treatment schedule in the Combination Arm, with FT596 administered on Day 1 and Day 15 at 900 million cells per dose. Patients with clinical benefit following administration of the first two-dose cycle are eligible for re-treatment with a second two-dose cycle. Additionally, patients with clinical response are eligible for re-treatment following disease progression.

Table 2. FT596 Interim Phase 1 Data – TEAEs of Interest
n (%)
Monotherapy
(n=13) Combination
(n=19)
All Grade Grade 3+ All Grade Grade 3+
CRS 1 (8%) — 2 (11%) —
ICANS — — — —
GvHD — — — —
Infections 6 (46%) 3 (23%) 6 (32%) 3 (16%)
FT596-related SAEs — — 1 (5%) a —
CRS = Cytokine Release Syndrome; GvHD = Graft vs. Host Disease; ICANS = Immune Cell-Associated Neurotoxicity Syndrome; TEAE = Treatment-Emergent Adverse Event; SAE = Severe Adverse Events
a Grade 2 CRS

Investor Event Webcast

The Company will host a live audio webcast on Tuesday, December 14, 2021 at 8:00 a.m. ET to highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphoma. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).