Gracell Biotechnologies Reports Third Quarter 2022 Unaudited Financial Results and Provides Corporate Update
Gracell Biotechnologies (NASDAQ: GRCL) reported its Q3 2022 financial results, highlighting significant advancements in its cancer treatment pipeline. The company plans to submit IND filings for its lead candidate, GC012F, targeting relapsed/refractory multiple myeloma, by year-end. Notable results from an ongoing trial show a 100% overall response rate (ORR) in newly diagnosed multiple myeloma patients. As of September 30, 2022, Gracell has $229.1 million in cash and equivalents, with a net loss of $24.2 million for the quarter due to increased R&D spending.
- Submission of IND filings for GC012F in the U.S. and China expected by year-end 2022.
- 100% overall response rate (ORR) in 13 newly diagnosed multiple myeloma patients treated with GC012F.
- Well-funded with $229.1 million cash runway for the next 24 months.
- Net loss increased to $24.2 million, up from $17.3 million in Q3 2021.
- Research and development expenses rose to $18.7 million from $12.5 million in Q3 2021.
- Increased foreign exchange loss of $0.9 million due to unfavorable currency fluctuations.
- On track to submit IND filings in U.S. and China for GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) in the fourth quarter 2022
- First clinical data from ongoing investigator-initiated trial (IIT) evaluating GC012F in newly-diagnosed multiple myeloma (NDMM) patients to be presented as oral session at 64th American Society of Hematology Annual Meeting and Exposition (ASH 2022)
- Continued patient enrollment and follow-up in the ongoing IIT evaluating GC012F in relapsed/refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL)
- Dosed first patient in registrational Phase 2 clinical trial evaluating GC007g for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
- Dosed first patients in IIT evaluating GC503 for the treatment of mesothelin-positive solid tumors
- Well-funded with cash runway for next 24 months
- Management to host conference call at 8:00 a.m. ET today
SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or “Company”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported third quarter unaudited financial results for the period ended September 30, 2022, and provided corporate updates.
“We continued to make important strides to advance our pipeline and remain on track to achieve key 2022 milestones. For our lead candidate GC012F, the BCMA/CD19 dual-targeting FasTCAR-T therapy, we look forward to submitting the IND filings for the treatment of RRMM in both the U.S. and China by the end of the year,” said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “We very much look forward to presenting the positive clinical data from the ongoing IIT evaluating GC012F in NDMM patients, as an oral session at the ASH annual meeting in December 2022. We have also started Gracell’s first Phase 2 trial with the first patient dosed with GC007g, an HLA-matched donor-derived allogeneic CAR-T therapy. Gracell remains well positioned and well capitalized to bring game-changing cell therapy to the patients in need.”
Pipeline Updates
FasTCAR Platform: Next-day manufacturing for autologous CAR-T cell therapy with enhanced cell fitness
GC012F: Autologous CAR-T therapy candidate dual-targeting B cell maturation antigen (BCMA) and CD19, currently being evaluated for the treatment of RRMM, NDMM and B-NHL.
- First clinical data from ongoing IIT evaluating GC012F in NDMM patients to be presented as oral session at ASH 2022.
- Presentation details: Session 704: Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT on Saturday, December 10, 2022 at 5:15 pm CT.
- As of the July 25, 2022 abstract data cutoff date, clinical data from this trial indicated
100% ORR and100% MRD negativity in the 13 NDMM patients treated.
- On track to submit the IND applications in the U.S. and China in the fourth quarter 2022 to evaluate GC012F for the treatment of RRMM.
- Enrollment and follow-up progressing in the IIT in China evaluating GC012F in r/r B-NHL.
TruUCAR Platform: Novel designs enabling “off-the-shelf” allogeneic CAR-T therapy
GC502: CD19/CD7 dual-directed allogeneic CAR-T cell therapy candidate being studied in an ongoing Phase 1 IIT in China for the treatment of B-cell malignancies. GC502 is manufactured from T cells of non-human leukocyte antigen (HLA) matched healthy donors.
- Updated data from single-arm, open-label IIT with longer follow-up of GC502 in B-ALL presented at EHA 2022.
SMART CART™ Module: With unique construct to take advantage of the suppressive tumor microenvironment (TME) and effectively combat solid tumors, SMART CART™ is designed to enhance CAR-T cell proliferation and duration of killing, and to resist exhaustion with improved persistence of CAR-T cells.
- Dosed first patients in a China IIT to evaluate GC503 for the treatment of mesothelin-positive solid tumors.
- Plan to commence a China IIT for GC506 in CLDN18.2-positive solid tumors.
GC007g for the treatment of B-ALL: 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.
- Dosed first patient in the Phase 2 portion of the registration Phase 1/2 clinical trial in China evaluating GC007g for the treatment of r/r B-ALL.
Financial Results for Third Quarter Ended September 30, 2022
As of September 30, 2022, the Company had RMB1,629.6 million (US
Net loss attributable to ordinary shareholders for the three months ended September 30, 2022 was RMB171.9 million (US
Research and development expenses for the three months ended September 30, 2022 were RMB133.4 million (US
Administrative expenses for the three months ended September 30, 2022 were RMB36.4 million (US
Interest income for the three months ended September 30, 2022 was RMB3.6 million (US
Foreign exchange loss for the three months ended September 30, 2022 was RMB6.1 million (US
As of September 30, 2022, 338,425,069 ordinary shares, par value of US
Conference Call and Webcast Details:
Monday, November 14, 2022 @ 8:00 a.m. ET
Investor domestic dial-in: (800) 715-9871
Investor international dial-in: +1(646) 307-1963
Conference ID: 4840587
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, 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 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 immunosuppressive drugs.
About SMART CART™
SMART CART™ is Gracell’s proprietary technology module designed to strengthen the functionality of CAR-T cells further, and aims to overcome tumor microenvironment (TME). SMART CART™ 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 CART™ 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 CART™ 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 and follow @GracellBio on LinkedIn.
Exchange Rate Information
This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB 7.1135 to US
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. 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 Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof. Gracell specifically disclaims any obligation to update any forward-looking statement, whether due to new information, future events, or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.
Unaudited Condensed Consolidated Balance Sheets
(All amounts in thousands, except for share and per share data)
| As of December 31, | As of September 30, | ||||||||
| 2021 | 2022 | ||||||||
| RMB | RMB | US$ | |||||||
| ASSETS | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | 1,829,006 | 1,431,460 | 201,232 | ||||||
| Short-term investments | 3,615 | 198,160 | 27,857 | ||||||
| Prepayments and other current assets | 52,459 | 40,337 | 5,670 | ||||||
| Total current assets | 1,885,080 | 1,669,957 | 234,759 | ||||||
| Property, equipment and software, net | 123,818 | 123,780 | 17,401 | ||||||
| Operating lease right-of-use assets | 29,652 | 26,133 | 3,674 | ||||||
| Other non-current assets | 21,587 | 18,510 | 2,602 | ||||||
| TOTAL ASSETS | 2,060,137 | 1,838,380 | 258,436 | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||||
| Current liabilities: | |||||||||
| Accruals and other current liabilities | 69,120 | 96,069 | 13,505 | ||||||
| Short-term borrowings | 66,100 | 117,600 | 16,532 | ||||||
| Operating lease liabilities, current | 17,527 | 21,699 | 3,050 | ||||||
| Amounts due to related parties | — | 3,674 | 517 | ||||||
| Current portion of long-term borrowings | 2,376 | 7,498 | 1,054 | ||||||
| Total current liabilities | 155,123 | 246,540 | 34,658 | ||||||
| Operating lease liabilities, non-current | 14,830 | 8,833 | 1,242 | ||||||
| Long-term borrowings | 54,349 | 48,149 | 6,769 | ||||||
| Other non-current liabilities | 8,464 | 7,908 | 1,112 | ||||||
| TOTAL LIABILITIES | 232,766 | 311,430 | 43,781 | ||||||
| Shareholders’ equity: | |||||||||
| Ordinary shares | 223 | 223 | 31 | ||||||
| Additional paid-in capital | 2,902,856 | 2,922,604 | 410,853 | ||||||
| Accumulated other comprehensive income/(loss) | (57,936 | ) | 98,710 | 13,877 | |||||
| Accumulated deficit | (1,017,772 | ) | (1,494,587 | ) | (210,106 | ) | |||
| Total shareholders’ equity | 1,827,371 | 1,526,950 | 214,655 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 2,060,137 | 1,838,380 | 258,436 | ||||||
Unaudited Condensed Consolidated Statements of Comprehensive Loss
(All amounts in thousands, except for share and per share data)
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||||
| 2021 | 2022 | 2021 | 2022 | |||||||||||||||
| RMB | RMB | US$ | RMB | RMB | US$ | |||||||||||||
| Revenue | ||||||||||||||||||
| Licensing and collaboration revenue | 366 | — | — | 366 | — | — | ||||||||||||
| Expenses | ||||||||||||||||||
| Research and development expenses | (88,617 | ) | (133,350 | ) | (18,746 | ) | (219,317 | ) | (372,245 | ) | (52,329 | ) | ||||||
| Administrative expenses | (42,861 | ) | (36,434 | ) | (5,122 | ) | (105,043 | ) | (103,090 | ) | (14,492 | ) | ||||||
| Loss from operations | (131,112 | ) | (169,784 | ) | (23,868 | ) | (323,994 | ) | (475,335 | ) | (66,821 | ) | ||||||
| Interest income | 2,985 | 3,583 | 504 | 5,651 | 8,781 | 1,234 | ||||||||||||
| Interest expense | (1,089 | ) | (1,864 | ) | (262 | ) | (3,736 | ) | (4,946 | ) | (695 | ) | ||||||
| Other income | 733 | 2,097 | 295 | 866 | 4,037 | 568 | ||||||||||||
| Foreign exchange loss, net | (802 | ) | (6,089 | ) | (856 | ) | (1,903 | ) | (9,484 | ) | (1,333 | ) | ||||||
| Others, net | — | 130 | 18 | (53 | ) | 132 | 19 | |||||||||||
| Loss before income tax | (129,285 | ) | (171,927 | ) | (24,169 | ) | (323,169 | ) | (476,815 | ) | (67,028 | ) | ||||||
| Income tax expense | — | — | — | — | — | — | ||||||||||||
| Net loss | (129,285 | ) | (171,927 | ) | (24,169 | ) | (323,169 | ) | (476,815 | ) | (67,028 | ) | ||||||
| Accretion of convertible redeemable preferred shares to redemption value | — | — | — | (1,989 | ) | — | — | |||||||||||
| Net loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (129,285 | ) | (171,927 | ) | (24,169 | ) | (325,158 | ) | (476,815 | ) | (67,028 | ) | ||||||
| Other comprehensive income/(loss) | ||||||||||||||||||
| Foreign currency translation adjustments, net of nil tax | 7,340 | 81,056 | 11,395 | (3,798 | ) | 156,647 | 22,021 | |||||||||||
| Total comprehensive loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (121,945 | ) | (90,871 | ) | (12,774 | ) | (328,956 | ) | (320,168 | ) | (45,007 | ) | ||||||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||||||||||||
| —Basic | 336,494,609 | 338,414,757 | 338,414,757 | 325,838,207 | 338,301,687 | 338,301,687 | ||||||||||||
| —Diluted | 336,494,609 | 338,414,757 | 338,414,757 | 325,838,207 | 338,301,687 | 338,301,687 | ||||||||||||
| Net loss per share attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | ||||||||||||||||||
| —Basic | (0.38 | ) | (0.51 | ) | (0.07 | ) | (1.00 | ) | (1.41 | ) | (0.20 | ) | ||||||
| —Diluted | (0.38 | ) | (0.51 | ) | (0.07 | ) | (1.00 | ) | (1.41 | ) | (0.20 | ) | ||||||
FAQ
What is the status of Gracell Biotechnologies' IND filings for GC012F?
What were Gracell's financial results for the third quarter of 2022?
What is the overall response rate for GC012F in clinical trials?
