- Presented early clinical data from a first-in-human Phase 1 investigator-initiated trial (IIT) of allogeneic TruUCAR candidate GC502 for relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) at AACR 2022; updated data to be presented at EHA 2022
- Oral presentation to highlight longer-term follow-up data from an IIT evaluating GC012F for relapsed/refractory multiple myeloma (RRMM) at ASCO 2022 and EHA 2022
- Plan to present initial data from an ongoing IIT evaluating GC012F for relapsed/refractory B-cell Non-Hodgkin’s lymphomas (r/r B-NHL) at EHA 2022
- Plan to file IND for GC012F for RRMM with
US FDA and China CDE during the second half 2022 - Well-funded with cash runway into 2024
- Management to host conference call at
8:00 a.m. ET today
“We were very encouraged about our early results from a first-in-human IIT study of our allogeneic TruUCAR candidate GC502 in patients with relapsed/refractory B-ALL, which we presented at AACR in early April. After a single infusion of the CD19/CD7 dual-directed off-the-shelf allogeneic CAR-T therapy GC502, three out of four patients achieved MRD- CR/CRi, and patients continue to be followed for ongoing response assessment,” said Dr.
Pipeline Highlights
FasTCAR Platform: Next-day manufacturing for autologous CAR-T cell therapy
GC012F: autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, currently being evaluated for the treatment of RRMM and B-NHL.
- Updated clinical data from an IIT evaluating GC012F for the treatment of RRMM selected for oral abstract presentation on
June 5 at 2022 American Society of Clinical Oncology Annual Meeting (ASCO 2022) and onJune 12 atEuropean Hematology Association 2022Congress (EHA 2022). - Plan to present Initial data from an ongoing IIT evaluating GC012F for the treatment of r/r B-NHL as a poster presentation on
June 10 at EHA 2022. - Plan to submit the
U.S. and China IND filings for RRMM in the second half of 2022.
TruUCAR Platform: Novel designs enabling “off-the-shelf” allogeneic CAR-T therapy
GC502: TruUCAR-enabled CD19/CD7 dual-directed allogeneic CAR-T cell therapy being studied in an ongoing Phase 1 IIT in
- First-in-human data from China IIT study in B-ALL patients were presented at AACR on
April 12, 2022 . As of the January 28, 2022 data cutoff date, four patients enrolled had received a single dose of GC502, including one patient at dose level 1 (DL1) 1.0x107 cells/kg and three patients at dose level 2 (DL2) 1.5x107 cells/kg. Three out of four patients achieved minimal residual disease negative complete response or complete response with incomplete count recovery (MRD- CR/CRi), and one patient achieved a partial response at month one and subsequently received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) on day 39. In two different formulation groups, safety profile appeared to be manageable and feasible. - Plan to present updated data with longer follow-up of GC502 in B-ALL on
June 10 at EHA 2022.
GC027: TruUCAR-enabled CD7-targeted allogenic CAR-T cell therapy for the treatment of T cell acute lymphoblastic leukemia (T-ALL).
- Target to have regulatory interactions globally and in
China in the next 12 months.
SMART CARTTM Technology: With unique construct to take advantage of the suppressive tumor microenvironment (TME) and effectively combat solid tumors, SMART CARTTM is designed to enhance CAR-T cell proliferation and duration of killing, and to resist exhaustion with improved persistence of CAR-T cells.
- On track to commence patient enrollment in a China IIT for GC503 in mesothelin-positive solid tumors in 2022.
- Plan to commence a China IIT for GC506 in CLDN18.2-positive solid tumors.
GC007g for the treatment of B-ALL: GC007g is an allogeneic CD19-targeted CAR-T cell therapy, derived from HLA-matched donor, for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy.
- Registrational Phase 1/2 clinical trial under a China IND is ongoing for the treatment of r/r B-ALL. Enrolling patients in the second dosing cohort prior to entering the Phase 2 part of the seamless-design study.
Corporate Highlights
- Opened the Company’s R&D Center in
San Diego, Calif. , during the first quarter of 2022.
Financial Results for the First Quarter Ended
As of
Net loss attributable to ordinary shareholders for the three months ended
Research and Development Expenses
Research and development expenses for the three months ended
Administrative Expenses
Administrative expenses for the three months ended
As of
Interest income for the three months ended
Conference Call and Webcast Details:
Investor domestic dial-in: 833-693-0545
Investor international dial-in: +1 661-407-1586
Conference ID: 2093503
Live webcast link: https://ir.gracellbio.com/news-events/events-and-presentations
A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.
About FasTCAR
CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted, and show enhanced proliferation, persistence, bone marrow migration, and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency, which may result in meaningful cost savings, and, together with fast turnaround time, it enables enhanced accessibility of cell therapies for cancer patients.
About TruUCAR
TruUCAR is Gracell’s proprietary technology platform and is designed to generate CAR-T cell therapies from high quality allogeneic T cells that can be administered “off-the-shelf” at lower cost and with improved accessibility of cell therapies for cancer patients. With differentiated design enabled by gene editing of unique genes, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft vs host disease (GvHD) without the need of being co-administered with additional strong immunosuppressant after conventional lymphodepletion. The novel dual-CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress rejection of allogeneic CAR-T cells by host T and NK cells (HvG).
About SMART CARTTM
SMART CARTTM is Gracell’s proprietary technology module designed to strengthen the functionality of CAR-T cells further, and aims to overcome tumor microenvironment (TME). SMART CARTTM includes altered expression of the receptor and signaling mechanism of an inhibitory TME molecule to enhance expansion and persistence and to reduce the exhaustion of CAR T cells. This design reverses and turns immunosuppressive signals of TME into stimulatory reactions of CAR-T cells. SMART CARTTM technology can be applied to many targets for the treatment of solid tumors.
About Gracell
Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CARTTM technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com
Follow @GracellBio on LinkedIn
Exchange Rate Information
This announcement contains translations of certain RMB amounts into
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the offering’s expected trading commencement and closing date. The words “anticipate,” “look forward to,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled “Risk Factors” in Gracell’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in Gracell’s subsequent filings with the
Media contact
marvin.tang@gracellbio.com
Investor contact
gracie.tong@gracellbio.com
Unaudited Condensed Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data)
As of | As of | ||||||||||
2021 | 2022 | ||||||||||
RMB | RMB | US$ | |||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | 1,829,006 | 1,621,119 | 255,725 | ||||||||
Short-term investments | 3,615 | 73,580 | 11,607 | ||||||||
Prepayments and other current assets | 52,459 | 66,603 | 10,506 | ||||||||
Total current assets | 1,885,080 | 1,761,302 | 277,838 | ||||||||
Property, equipment and software | 123,818 | 118,536 | 18,699 | ||||||||
Operating lease right-of-use assets | 29,652 | 25,548 | 4,030 | ||||||||
Other non-current assets | 21,587 | 27,855 | 4,394 | ||||||||
TOTAL ASSETS | 2,060,137 | 1,933,241 | 304,961 | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||||||
Current liabilities: | |||||||||||
Short-term borrowings | 66,100 | 86,000 | 13,566 | ||||||||
Operating lease liabilities, current | 17,527 | 16,596 | 2,618 | ||||||||
Current portion of long-term borrowings | 2,376 | 2,376 | 376 | ||||||||
Amounts due to related parties | — | 4,579 | 722 | ||||||||
Accruals and other current liabilities | 69,120 | 77,571 | 12,236 | ||||||||
Total current liabilities | 155,123 | 187,122 | 29,518 | ||||||||
Long-term borrowings | 54,349 | 54,349 | 8,573 | ||||||||
Operating lease liabilities, non-current | 14,830 | 11,568 | 1,825 | ||||||||
Other non-current liabilities | 8,464 | 7,677 | 1,211 | ||||||||
TOTAL LIABILITIES | 232,766 | 260,716 | 41,127 | ||||||||
Commitments and contingencies | |||||||||||
Shareholders’ equity: | |||||||||||
Ordinary shares | 223 | 223 | 35 | ||||||||
Additional paid-in capital | 2,902,856 | 2,913,030 | 459,519 | ||||||||
Accumulated other comprehensive loss | (57,936 | ) | (64,373 | ) | (10,155 | ) | |||||
Accumulated deficit | (1,017,772 | ) | (1,176,355 | ) | (185,565 | ) | |||||
Total shareholders’ equity | 1,827,371 | 1,672,525 | 263,834 | ||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 2,060,137 | 1,933,241 | 304,961 | ||||||||
Unaudited Condensed Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data)
For the three months ended | |||||||||||
2021 | 2022 | ||||||||||
RMB | RMB | US$ | |||||||||
Expenses | |||||||||||
Research and development expenses | (65,433 | ) | (121,837 | ) | (19,219 | ) | |||||
Administrative expenses | (31,759 | ) | (37,890 | ) | (5,977 | ) | |||||
Loss from operations | (97,192 | ) | (159,727 | ) | (25,196 | ) | |||||
Interest income | 932 | 2,496 | 394 | ||||||||
Interest expense | (1,235 | ) | (1,425 | ) | (225 | ) | |||||
Other income | 128 | 143 | 23 | ||||||||
Foreign exchange loss, net | (298 | ) | (71 | ) | (11 | ) | |||||
Others, net | — | 1 | — | ||||||||
Loss before income tax | (97,665 | ) | (158,583 | ) | (25,015 | ) | |||||
Income tax expense | — | — | — | ||||||||
Net loss | (97,665 | ) | (158,583 | ) | (25,015 | ) | |||||
Accretion of convertible redeemable preferred shares to redemption value | (1,989 | ) | — | — | |||||||
Net loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (99,654 | ) | (158,583 | ) | (25,015 | ) | |||||
Other comprehensive income | |||||||||||
Foreign currency translation adjustments, net of nil tax | 23,629 | (6,437 | ) | (1,015 | ) | ||||||
Total comprehensive loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (76,025 | ) | (165,020 | ) | (26,030 | ) | |||||
Weighted average number of ordinary shares used in per share calculation: | |||||||||||
—Basic | 304,488,419 | 338,131,447 | 338,131,447 | ||||||||
—Diluted | 304,488,419 | 338,131,447 | 338,131,447 | ||||||||
Net loss per share attributable to Inc.’s ordinary shareholders | |||||||||||
—Basic | (0.33 | ) | (0.47 | ) | (0.07 | ) | |||||
—Diluted | (0.33 | ) | (0.47 | ) | (0.07 | ) |
Source:
2022 GlobeNewswire, Inc., source