Gracell Biotechnologies Reports Fourth Quarter and Fiscal Year 2020 Unaudited Financial Results and Provides Corporate Update
Gracell Biotechnologies reported significant milestones, including a successful IPO that raised approximately $220 million. Their lead CAR-T candidate, GC012F, has shown promising results in treating multiple myeloma, with an overall response rate of 93.8% among high-risk patients. Additionally, the company received IND approval for GC019F for B-ALL treatments and plans to expand R&D operations in the U.S. and China. Despite increased expenses, including a net loss of $42.1 million for 2020, Gracell is well-positioned to advance its clinical programs and expand its manufacturing capabilities.
- Successful IPO raised $220 million.
- GC012F demonstrated a 93.8% overall response rate in high-risk multiple myeloma patients.
- Received IND approval for GC019F, advancing treatment options for B-ALL.
- Plans to expand R&D and GMP manufacturing in the U.S. and China.
- Net loss increased to $42.1 million in 2020 from $200.9 million in 2019.
- Research and development expenses rose to $25.9 million, up from $19.0 million in 2019.
Reported interim readouts for lead CAR-T product candidates: FasTCAR-enabled dual-targeting BCMA/CD19 autologous CAR-T product candidate GC012F for the treatment of multiple myeloma and TruUCAR-enabled CD7-directed CAR-T product candidate GC027 for the treatment of T-ALL
Completed initial public offering of ADSs for net proceeds of
Conference call tomorrow, March 10, 2021 at 8:00 am ET
SUZHOU and SHANGHAI, China, March 09, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies, today reported its unaudited financial results for the fourth quarter and fiscal year ended December 31, 2020 and recent business highlights. Gracell will host a conference call tomorrow, Wednesday, March 10, at 8:00 am Eastern Time.
“We are very pleased with the substantial progress made thus far in 2021 and over the course of 2020. We recently closed a successful initial public offering that was supported by top-tier institutional investors. We believe their support reflects confidence in our proprietary FasTCAR and TruUCAR platforms that enable highly differentiated autologous and allogeneic CAR-T therapies,” commented Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “Our lead asset GC012F, a FasTCAR-enabled dual-targeting BCMA/CD19 CAR-T cell therapy, currently being studied in multiple myeloma, has shown promising results including high risk patients. We were thrilled to present results from an interim analysis at last year’s American Society of Hematology (ASH) Annual Meeting. We look forward to providing further updates at upcoming scientific meetings.”
“Following the success of our recent business developments, the Gracell team continues to feel energized as we work towards accomplishing our operational goals for 2021. Looking ahead, we are well-positioned to continue to fund our R&D programs and expansion of operations in China and the U.S. We have just recently received IND approval in China for GC019F, a FasTCAR-enabled CD19-targeted CAR-T therapy for the treatment of B-ALL, and we believe this is a validation of our next-day manufacturing FasTCAR platform. We look forward to sharing updates of our lead programs at major medical conferences. To support our clinical operations, we plan to establish R&D capabilities in the U.S. and to significantly expand our GMP manufacturing facility in China during 2021 and beyond. With tremendous energy and dedication, we will continue to strive towards advancing our innovative CAR-T pipeline for difficult to treat cancers while driving further value for our shareholders,” concluded Dr. Cao.
* Translation from Renminbi to U.S. dollars of cash balance on January 31, 2021 is for the convenience of the reader and made at a rate of RMB6.4709 to US
2020 and Subsequent Highlights
GC012F for the treatment of multiple myeloma (MM):
GC012F is a FasTCAR-enabled dual-targeting BCMA/CD19 autologous chimeric antigen receptor (CAR)-T cell therapy that is currently being studied in an ongoing Phase 1 investigator-initiated trial (IIT) in China for the treatment of MM patients who are relapsed from or refractory to (R/R) prior therapies.
- An interim data readout was presented as an oral presentation at the ASH’s 2020 Annual Meeting (Press Release Dec 2020)
• As of July 17, 2020, the study had enrolled and treated 16 patients at three dose levels with the highest dose level at 3x105 cells/kg. Notably, the vast majority of this study population (93.8% ) belong to a subgroup of MM patients with high-risk features, a difficult to treat patient population. Overall Response Rate (ORR) at time of data cut off was93.8% with responses being VGPR or better.100% of the patients treated at the highest dose level (n=6) achieved minimal residual disease negative stringent complete response (MRD- sCR) that was maintained through a landmark analysis at six months (n=4). GC012F showed a favorable safety profile with primarily low grade cytokine release syndrome (CRS) (14 out of 16 patients (87.5% ) Grade 1/2, 2 (12.5% ) patients Grade 3, no Grade 4 or 5) and no patients experienced any immune effector cell-associated neurotoxicity syndrome (ICANS)
GC019F for the treatment of with B-cell acute lymphoblastic leukemia (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 Release Jan 2021)
GC027 for the treatment of adult T cell acute lymphoblastic leukemia (T-ALL):
GC027 is a TruUCAR-enabled allogeneic CD7-targeted CAR-T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult R/R T-ALL. GC027 is manufactured from T cells of non-HLA (human leukocyte antigen)-matched healthy donors.
- Preliminary efficacy and safety data were presented as oral presentations at AACR (the American Association for Cancer Research) Virtual Annual Meeting 2020 (Press Release April 2020) and EHA (European Hematology Association) 25th Annual Congress 2020.
• As of February 2020, the study had enrolled and treated five patients who had failed a median of five prior-lines of therapy. All five evaluable patients achieved a response, CR or CRi, including four patients, or80% , achieving MRD- CR on Day 28 after treatment. Four out of five patients experienced CRS of Grade 3 and one out of five patients experienced CRS of Grade 4. No patients developed ICANS or graft-versus-host-disease (GvHD)
GC007g for the treatment of B-ALL:
GC007g is a donor-derived allogeneic CD19-targeted 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.
- China’s NMPA approved a pivotal seamless Phase 1/2 clinical trial for GC007g. (Press Release Jan 2021) The study is ongoing and accruing patients
Corporate Highlights:
- Expanded executive leadership team with appointments of Chief Medical Officer Dr. Martina Sersch, M.D., and Chief Financial Officer Dr. Kevin Xie, both bringing extensive knowledge and leadership experience to Gracell (Press Release July 2020)
- Secured
$100 million in Series C funding in a round led by Wellington Management Company, OrbiMed and Morningside Ventures, and joined by Vivo Capital. Existing investors Temasek Holdings, Lilly Asia Ventures, and King Star Med LP also participated (Press Release Oct 2020) - Completed a successful initial public offering of American Depositary Shares (ADSs), raising net proceeds of approximately
$220 million , and commenced trading on the NASDAQ Global Select Market under the ticker symbol “GRCL” (Press Release Jan 2021) - Gracell’s manufacturing site in Suzhou has been granted the Medical Products Manufacturing Certificate from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for the production of CAR-T cell therapy products (Press Release Jan 2021)
Financial Results for the Fourth Quarter Ended December 31, 2020
Research and development expenses for the three months ended December 31, 2020 were RMB60.7 million (US
Administrative expenses for the three months ended December 31, 2020 were RMB24.8 million (US
Interest income for the fourth quarter of 2020 was RMB0.5 million (US
Foreign exchange loss for the three months ended December 31, 2020 was RMB0.7 million (US
Net loss attributable to ordinary shareholders for the three months ended December 31, 2020 was RMB99.9 million (US
Financial Results for the Fiscal Year Ended December 31, 2020
Research and development expenses for the year ended December 31, 2020 were RMB168.8 million (US
Administrative expenses for the year ended December 31, 2020 were RMB45.6 million (US
Interest income for the year ended December 31, 2020 was RMB2.9 million (US
Foreign exchange loss for the year ended December 31, 2020 was RMB2.9 million (US
Net loss attributable to ordinary shareholders for the year ended December 31, 2020 was RMB274.6 million (US
Balance Sheet Highlights
As of December 31, 2020, we had RMB773.1 million (US
In addition, as of December 31, 2020, the Company had short-term borrowings and current portion of long-term borrowings of RMB50.0 million (US
Conference Call Details
Wednesday, March 10, 2021 at 8:00 am ET
Investor domestic dial-in: 877-407-0784
Investor international dial-in: 201-689-8560
Conference ID: 13716516
Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations
The webcast replay will be available on the Gracell website at ir.gracellbio.com for 90 days following the completion of the call.
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 (22 to 36 hours), 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 as well as graft vs host disease (GvHD) without the need of being co-ministered with immunosuppressive antibody 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.
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 RMB6.5250 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," "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: the clinical results of our product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of our clinical trials and marketing approval, our ability to achieve commercial success if any of our product candidates is approved, our ability to obtain and maintain protection of intellectual property for our product candidates and technology platforms, the future developments of the COVID-19 outbreaks, and other factors more fully discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission (the “SEC”) and in any subsequent filings made by the Company with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.
Media Contact
Marvin Tang
marvin.tang@gracellbio.com
Investor Contact
Gracie Tong
Gracie.tong@gracellbio.com
GRACELL BIOTECHNOLOGIES INC.
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2019 AND 2020
(All amounts in thousands, except for share and per share data, unless otherwise noted)
| As of December 31, | ||||||||||
| 2019 | 2020 | 2020 | ||||||||
| RMB | RMB | US$ | RMB | US$ | ||||||
| (Pro forma) (Note 1) | ||||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | 312,058 | 754,308 | 115,603 | 754,308 | 115,603 | |||||
| Short-term investments | 4,200 | 18,743 | 2,872 | 18,743 | 2,872 | |||||
| Prepayments and other current assets | 24,095 | 42,418 | 6,501 | 42,418 | 6,501 | |||||
| Total current assets | 340,353 | 815,469 | 124,976 | 815,469 | 124,976 | |||||
| Property, equipment and software | 48,323 | 119,083 | 18,250 | 119,083 | 18,250 | |||||
| Other non-current assets | 23,541 | 30,398 | 4,658 | 30,398 | 4,658 | |||||
| TOTAL ASSETS | 412,217 | 964,950 | 147,884 | 964,950 | 147,884 | |||||
| LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT | ||||||||||
| Current liabilities: | ||||||||||
| Short-term borrowings | — | 49,990 | 7,661 | 49,990 | 7,661 | |||||
| Current portion of long-term borrowings | — | 970 | 149 | 970 | 149 | |||||
| Accruals and other current liabilities | 18,166 | 42,401 | 6,498 | 42,401 | 6,498 | |||||
| Total current liabilities | 18,166 | 93,361 | 14,308 | 93,361 | 14,308 | |||||
| Long-term borrowings | — | 51,926 | 7,958 | 51,926 | 7,958 | |||||
| Convertible loans | 138,695 | — | — | — | — | |||||
| TOTAL LIABILITIES | 156,861 | 145,287 | 22,266 | 145,287 | 22,266 | |||||
| Commitments and contingencies | ||||||||||
| Mezzanine equity: | ||||||||||
| Series A convertible redeemable preferred shares (US | 82,334 | 110,468 | 16,930 | — | — | |||||
| Series B-1 convertible redeemable preferred shares (US | — | 142,481 | 21,836 | — | — | |||||
| Series B-2 convertible redeemable preferred shares (US | 465,509 | 495,799 | 75,985 | — | — | |||||
| Series C convertible redeemable preferred shares (US | — | 658,788 | 100,963 | — | — | |||||
| Total mezzanine equity | 547,843 | 1,407,536 | 215,714 | — | — | |||||
| Shareholders’ deficit: | ||||||||||
| Ordinary shares(par value of US | 68 | 68 | 10 | 181 | 28 | |||||
| Additional paid-in capital | — | — | — | 1,407,423 | 215,696 | |||||
| Accumulated other comprehensive loss | (3,159 | ) | (23,912 | ) | (3,665 | ) | (23,912 | ) | (3,665 | ) |
| Accumulated deficit | (289,396 | ) | (564,029 | ) | (86,441 | ) | (564,029 | ) | (86,441 | ) |
| Total shareholders’ deficit | (292,487 | ) | (587,873 | ) | (90,096 | ) | 819,663 | 125,618 | ||
| TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ DEFICIT | 412,217 | 964,950 | 147,884 | 964,950 | 147,884 | |||||
Note 1: The unaudited pro forma balance sheet information as of December 31, 2020 assumes the automatic conversion of all of the outstanding convertible preferred shares into ordinary shares at a conversion ratio of 1:1, as if the conversion had occurred as of December 31, 2020.
GRACELL BIOTECHNOLOGIES INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
FOR THE YEARS ENDED DECEMBER 31, 2018, 2019 AND 2020
(All amounts in thousands, except for share and per share data, unless otherwise noted)
| For the years ended December 31, | ||||||||
| 2018 | 2019 | 2020 | ||||||
| RMB | RMB | RMB | US$ | |||||
| Expenses | ||||||||
| Research and development expenses | (52,243 | ) | (119,218 | ) | (168,830 | ) | (25,874 | ) |
| Administrative expenses | (10,261 | ) | (27,362 | ) | (45,566 | ) | (6,983 | ) |
| Loss from operations | (62,504 | ) | (146,580 | ) | (214,396 | ) | (32,857 | ) |
| Interest income | 1,435 | 3,932 | 2,870 | 440 | ||||
| Interest expense | — | — | (2,155 | ) | (330 | ) | ||
| Other income | 256 | 1,449 | 4,707 | 721 | ||||
| Foreign exchange gain, net | — | 2,556 | (2,914 | ) | (447 | ) | ||
| Others, net | 20 | (21 | ) | (12 | ) | (2 | ) | |
| Loss before income tax | (60,793 | ) | (138,664 | ) | (211,900 | ) | (32,475 | ) |
| Income tax expense | — | — | — | — | ||||
| Net loss | (60,793 | ) | (138,664 | ) | (211,900 | ) | (32,475 | ) |
| Deemed dividend to convertible redeemable preferred shareholders | — | (25,390 | ) | — | — | |||
| Accretion of convertible redeemable preferred shares to redemption value | (12,199 | ) | (36,802 | ) | (62,733 | ) | (9,614 | ) |
| Net loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (72,992 | ) | (200,856 | ) | (274,633 | ) | (42,089 | ) |
| Other comprehensive loss | ||||||||
| Foreign currency translation adjustments, net of nil tax | — | (3,159 | ) | (20,754 | ) | (3,181 | ) | |
| Total comprehensive loss attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | (72,992 | ) | (204,015 | ) | (295,387 | ) | (45,270 | ) |
| Weighted average number of ordinary shares used in per share calculation: | ||||||||
| —Basic | 100,089,552 | 99,053,363 | 99,044,776 | 99,044,776 | ||||
| —Diluted | 100,089,552 | 99,053,363 | 99,044,776 | 99,044,776 | ||||
| Net loss per share attributable to Gracell Biotechnologies Inc.’s ordinary shareholders | ||||||||
| —Basic | (0.73 | ) | (2.03 | ) | (2.77 | ) | (0.42 | ) |
| —Diluted | (0.73 | ) | (2.03 | ) | (2.77 | ) | (0.42 | ) |
FAQ
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