Reported updated long-term follow-up data for TruUCAR-enabled CD7-targeted CAR-T product candidate GC027 for the treatment of T-ALL at AACR 2021 Annual Meeting
Signed agreement with Lonza to manufacture FasTCAR-enabled product candidates in the
Completed initial public offering of ADSs for net proceeds of
“We are thrilled to have ushered in the new year as a public company following a successful initial public offering that was supported by top-tier institutional investors,” commented Dr.
“We plan to build on the momentum achieved during the first quarter with several near-term catalysts expected during 2021. As we continue to ramp up clinical development efforts, we continue to expand our team in the
First Quarter 2021 and Subsequent Highlights
GC027 for the treatment of adult relapsed/refractory T cell acute lymphoblastic leukemia (r/r T-ALL):
GC027 is a TruUCAR-enabled CD7-targeted allogeneic CAR-T cell therapy being studied in an ongoing Phase 1 IIT in
- Updated long-term follow-up data (data cut-off as of
February 4, 2021 ) for GC027 was presented at the 2021American Association for Cancer Research (AACR) Annual Meeting (Press ReleaseApril 2021 )- Patients had received a median of six prior lines of therapy and received a single infusion of TruUCAR GC027 in one of three dose levels with the highest dose level at 1.5x107 cells/kg. Six patients (100%) treated achieved a complete remission with or without complete blood count recovery (CR/CRi) and five of the six patients (83%) achieved MRD- CR. At 6 months post treatment, three out of five patients (60%) had maintained MRD- CR. After 18.5 months of follow up for the initial patients treated, one patient continued to be MRD- CR at 16.8 months. One patient maintained MRD- CR until 9 months and one patient with primary refractory disease (no response to VDP) maintained his MRD- CR status until month 7. One additional patient treated presented initially with a high tumor burden and extensive extramedullary (EM) disease. After treatment with GC027 and as confirmed by PET CT scan, all EM lesions resolved. The patient achieved MRD- CR at day 28. All six patients tolerated a single infusion of TruUCAR GC027. No events of neurotoxicity (ICANS) or acute graft-versus-host disease (aGvHD) were observed. Cytokine release syndrome (CRS) occurred in all patients and was managed with standard of care including Tocilizumab.
GC007g for the treatment of B-cell acute lymphoblastic leukemia (B-ALL):
GC007g is a donor-derived CD19-targeted allogeneic CAR-T cell therapy for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy. The allogeneic approach, utilizing T-cells from an HLA-matched healthy donor, has the potential to provide a novel treatment approach to patients not eligible for standard of care.
- Enrolled first patient in the pivotal seamless Phase 1/2 clinical trial to evaluate the safety and efficacy of GC007g in r/r B-ALL patients. (Press Release
March 2021 ) We received IND approval for the pivotal seamless Phase 1/2 trial of GC007g from China’s NMPA inDecember 2020 . (Press ReleaseJan 2021 ) The study is ongoing and accruing patients.
GC019F for the treatment of B-ALL:
GC019F is a FasTCAR-enabled CD19-targeted autologous CAR-T cell therapy for the treatment of r/r B-ALL.
- China’s
National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for the Phase I study of GC019F (Press ReleaseJan 2021 )
Corporate Highlights:
- Completed a successful initial public offering of American Depositary Shares (ADSs), raising net proceeds of approximately
US$220 million , and commenced trading on the NASDAQ Global Select Market under the ticker symbol “GRCL” (Press ReleaseJan 2021 ) - Gracell’s manufacturing site in
Suzhou has been granted the Medical Products Manufacturing Certificate from theJiangsu Medical Products Administration (Jiangsu is a province/state inChina ) for the production of CAR-T cell therapy products (Press ReleaseJan 2021 ) - Entered into a Manufacturing Service Agreement with Lonza (SIX:LONN) for clinical manufacturing of Gracell’s FasTCAR-enabled CAR-T cell product candidates in the
U.S. (Press ReleaseMarch 2021 ) - Expanded executive leadership team with appointment of Jenny (Yajin) Ni, Ph.D., M.D., as Chief Technology Officer.
Dr. Ni will strategically lead CAR-T process development, CMC and supply chain management activities at Gracell (Press ReleaseMay 2021 )
Financial Results for the First Quarter Ended
Research and development expenses for the three months ended
Administrative expenses for the three months ended
Interest income for the first quarter of 2021 was
Foreign exchange loss for the three months ended
Net loss attributable to ordinary shareholders for the three months ended
Balance Sheet Highlights
As of
We early adopted ASU 2016-02, Lease (Topic 842), in the first quarter of 2021. As of
In the first quarter of 2021, we received a payment from the depositary bank of
In addition, as of
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, increasing the accessibility of cell therapies for cancer patients.
About TruUCAR
TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered “off-the-shelf” at lower cost and with greater convenience. With differentiated design enabled by gene editing, 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 immunosuppressive drugs.
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, 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 production 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 expected trading commencement and closing date of the offering. 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 Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data)
As of | As of | |||||
2020 | 2021 | |||||
RMB | RMB | US$ | ||||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | 754,308 | 2,157,833 | 329,350 | |||
Short-term investments | 18,743 | 11,614 | 1,773 | |||
Prepayments and other current assets | 42,418 | 54,899 | 8,379 | |||
Total current assets | 815,469 | 2,224,346 | 339,502 | |||
Property, equipment and software | 119,083 | 117,732 | 17,969 | |||
Operating lease right-of-use assets | — | 26,077 | 3,980 | |||
Other non-current assets | 30,398 | 19,902 | 3,037 | |||
TOTAL ASSETS | 964,950 | 2,388,057 | 364,488 | |||
LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT | ||||||
Current liabilities: | ||||||
Short-term borrowings | 49,990 | 59,990 | 9,156 | |||
Operating lease liabilities, current | — | 16,244 | 2,479 | |||
Current portion of long-term borrowings | 970 | 874 | 133 | |||
Accruals and other current liabilities | 42,401 | 43,912 | 6,702 | |||
Total current liabilities | 93,361 | 121,020 | 18,470 | |||
Long-term borrowings | 51,926 | 51,926 | 7,925 | |||
Operating lease liabilities, non-current | — | 9,597 | 1,465 | |||
Other non-current liabilities | — | 11,078 | 1,691 | |||
TOTAL LIABILITIES | 145,287 | 193,621 | 29,551 | |||
Commitments and contingencies | ||||||
Mezzanine equity: | ||||||
Series A convertible redeemable preferred shares | 110,468 | — | — | |||
Series B-1 convertible redeemable preferred shares | 142,481 | — | — | |||
Series B-2 convertible redeemable preferred shares | 495,799 | — | — | |||
Series C convertible redeemable preferred shares | 658,788 | — | — | |||
Total mezzanine equity | 1,407,536 | — | — | |||
Shareholders’ equity (deficit): | ||||||
Ordinary shares | 68 | 222 | 34 | |||
Additional paid-in capital | — | 2,858,181 | 436,244 | |||
Accumulated other comprehensive loss | (23,912 | ) | (284 | ) | (43 | ) |
Accumulated deficit | (564,029 | ) | (663,683 | ) | (101,298 | ) |
Total shareholders’ equity (deficit) | (587,873 | ) | 2,194,436 | 334,937 | ||
TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY (DEFICIT) | 964,950 | 2,388,057 | 364,488 | |||
Unaudited Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data)
For the three months ended | ||||||
2020 | 2021 | |||||
RMB | RMB | US$ | ||||
Expenses | ||||||
Research and development expenses | (27,355 | ) | (65,433 | ) | (9,987 | ) |
Administrative expenses | (5,625 | ) | (31,759 | ) | (4,847 | ) |
Loss from operations | (32,980 | ) | (97,192 | ) | (14,834 | ) |
Interest income | 1,163 | 932 | 142 | |||
Interest expense | (206 | ) | (1,235 | ) | (188 | ) |
Other income | 5 | 128 | 20 | |||
Foreign exchange gain (loss), net | 79 | (298 | ) | (45 | ) | |
Others, net | (15 | ) | — | — | ||
Loss before income tax | (31,954 | ) | (97,665 | ) | (14,905 | ) |
Income tax expense | — | — | — | |||
Net loss | (31,954 | ) | (97,665 | ) | (14,905 | ) |
Accretion of convertible redeemable preferred shares to redemption value | (10,739 | ) | (1,989 | ) | (304 | ) |
Net loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (42,693 | ) | (99,654 | ) | (15,209 | ) |
Other comprehensive income | ||||||
Foreign currency translation adjustments, net of nil tax | 3,524 | 23,629 | 3,607 | |||
Total comprehensive loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (39,169 | ) | (76,025 | ) | (11,602 | ) |
Weighted average number of ordinary shares used in per share calculation: | ||||||
—Basic | 99,044,776 | 304,488,419 | 304,488,419 | |||
—Diluted | 99,044,776 | 304,488,419 | 304,488,419 | |||
Net loss per share attributable to | ||||||
—Basic | (0.43 | ) | (0.33 | ) | (0.05 | ) |
—Diluted | (0.43 | ) | (0.33 | ) | (0.05 | ) |
Source:
2021 GlobeNewswire, Inc., source