Analyst Conference Summary

biotechnology

conference date: May 9, 2024
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: Making progress in early clinical trials.

Basic data (GAAP):

Revenue was $2 million, up sequentially from $1.7 million, and way down from $59 million year-earlier. All revenue was from collaborations.

GAAP net income was negative $48 million, down sequentially from negative $44.1 million, and down from negative $19 million year-earlier.

GAAP EPS, diluted, was negative $0.47, down sequentially from negative $0.45, and down from negative $0.19 year-earlier.

Guidance:

Will end 2024 with over $270 million in cash and equivalents.

Conference Highlights:

Scott Wolchko, President and CEO of Fate Therapeutics, said: "We made great progress across three key areas of clinical focus – we treated the first patient with our off-the-shelf FT819 CAR T-cell therapy for autoimmunity, we initiated patient enrollment without conditioning chemotherapy for our ADR-armed FT522 CAR NK cell therapy, and we treated the first patient with our multiplexed-engineered FT825 CAR T-cell therapy for solid tumors. As we look toward the middle of the year, we plan to expand clinical development in autoimmunity with our off-the-shelf FT819 and FT522 programs, where we believe our iPSC product platform is highly differentiated and has the potential to overcome numerous challenges that hinder treatment of patients with cell therapies, such as the requirement for apheresis and Cy / Flu conditioning, extended hospitalization, risk of secondary malignancies, and limited access. In addition, while we continue with the preclinical assessment of our next-generation, BCMA-targeted cell product candidates, we do not intend to further advance FT576 into Phase 1 dose expansion in relapsed / refractory multiple myeloma."

Believes cell therapy can be used to engineer immunotherapies, starting with FT819.

The cash and equivalents balance ended the quarter $391 million, up sequentially from $316 million. In Q1 raised $80 million in a commmon stock offering and $20 million frompre-funded warrants.

In Q1 2024 FT825, or ONO-8250, in partnership with Ono, began dosing in a Phase 1 study for HER2-positive solid tumors. Had IND submitted in 2H 2023. Plan is to test both as a monotherapy and combined with cetuximab.

In Q3 2023 Fate started Phase 1 for FT522, following a May FDA clearance. FT522 is an off-the-shelf, multiplexed-engineered, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell product candidate that incorporates five synthetic controls of cell function. It is armed with Fate's proprietary alloimmune defense receptor (ADR) technology, which is comprised of a synthetic engineered receptor targeting 4-1BB and is designed to promote anti-tumor activity without requiring administration of intensive conditioning chemotherapy to patients. Will be tried with both chemo conditioning and without. Believes will initially enroll heavily pretreated B-cell lymphoma patients. Currently (Q1 2024) enrolling Regimen A, three doses at 300 million cells per dose. Expects some data in 2H 2024. Also expects to submit an IND for FT522 for autoimmune disease.

FT819 in Q4 2023 completed enrolling Phase 1 patients for B-cell lymphoma and chronic lymphocytic leukemia. Was awarded $8 million by CIRM in Q1 2024. Will share more data in May 2024. FT819 is a T-cell product candidate manufactured from a clonal master iPSC line. FT819 incorporates several novel synthetic controls of cell function, including the integration of a novel CD19-targeted 1XX CAR construct into the T-cell receptor alpha constant (TRAC) locus, which is intended to promote uniform CAR expression, enhance T-cell potency, and prevent graft-versus-host disease. But all future development of FT819 will be in autoimmunity.

FT819 in Q1 2024 enrolled its first systemic lupus erythematosus (SLE) Phase 1 patient, with good results. Also completed Phase 1 dose escalation for autoimmunity in CLL and ALL patients. Plans to amend the protocol to allow for a changed procedure for autoimmune diseases, in Q2 2024.

In Q2 2024 opened the FT522 BCL (B cell lymphoma) conditioning-free treatment arm. The Phase 1 study with conditioning chemotherapy is ongoing. Plans to initiate study of B cell mediated autoimmune diseases. 522 includes ADR (Alloimmune Defense Receptor) technology.

The FT576 program is in Phase 1 for multiple myeloma. Dose escalation was completed in Q1 2024.

Also in partnership with Ono, a second undisclosed potential therapy in preclinical development.

Operating expense of $53 million consisted of $32 million for R&D; $21 million for SG&A. Operating income negative $51 million. Interest income $4 million. Change in fair value of milestones $1 million. Other income $0 million.

Q&A selective summary:

Enrolling autoimmune study, impact of second study? Current study has 2 conditioning alternatives allowed. Looking at FT819 results, could change to Bendamuscine based conditioning. So we think we can add a cytopsin only conditioning option. So three physician choices.

522 without lymphodepletion goals. Study started with cy-flu conditioning. Seeing better persistence. So hope for good results without lymphodepletion. Believes 522 can thrive in an allogeneic disease system.

We have shown activity in primary, secondary, and tertiary tissues using a variety of methods from sampling cells to using proxy markers.

Competitive landscape, bispecific CART? CD19 engagers, we recognize the potential benefits in the autoimmune space. We are going up directly against T-cell engagers. We want to minimize hospitalization and maximize safety. Any new product from us will likely incorporate ADR (Alloimmune Defense Receptor) technology.

We are doing a lot of work, looking at potential expansion strategies in immonotherapies.

819 lupus timeline? update on first three to five patients by end of this year.

We do believe an engager could be multiply dosed.

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