Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or the
“Company”), a global clinical-stage biopharmaceutical company
dedicated to developing innovative and highly efficacious cell
therapies for the treatment of cancer and autoimmune diseases,
today reported second quarter unaudited financial results for the
period ended June 30, 2023, and provided corporate updates.
“We are delighted with the significant
milestones achieved in the past few months across our reprioritized
pipeline. Encouraged by the latest impressive clinical data for
GC012F across hematological indications presented at ASCO and EHA,
we continue to focus on the development and expansion of this
highly-competitive, next-generation CAR-T product candidate. The
Phase 1b part of the RRMM US IND trial has commenced as patient
screening is underway. We also continue to explore the potential of
GC012F in early line, and look forward to presenting longer
follow-up data from the ongoing clinical IIT evaluating GC012F in
newly diagnosed multiple myeloma (NDMM) at an upcoming
international medical conference in September,” said Dr. William
(Wei) Cao, founder, Chairman and CEO of Gracell. “The expansion
into the autoimmune diseases is also a priority and we are on track
to file the US IND in 2023 to conduct a Phase 1 trial for GC012F in
rSLE. We have dosed multiple patients in the rSLE IIT and
anticipate that topline data from this ongoing study will be
available during the first half of 2024.”
Dr. Cao continued, “With the completion of a
private placement financing of $100 million upfront and up to $50
million upon warrant exercise led by well-regarded healthcare
investors, we strengthened our balance sheet and extended our
runway into the second half of 2026.”
Pipeline Summary
FasTCAR-T GC012F: Autologous
BCMA/CD19 dual targeting CAR-T therapy candidate utilizing FasTCAR
next-day manufacturing to significantly shorten patient wait times
and enhance cell fitness
FasTCAR-T GC012F in relapsed refractory
multiple myeloma (RRMM):
- Initiated the Company-sponsored
Phase 1b/2 clinical trial in U.S. (NCT05850234) evaluating GC012F
in RRMM
- Patient recruitment has commenced
in the Phase 1b part of the trial
- On track to initiate the
Company-sponsored Phase 1/2 clinical trial in China evaluating
GC012F in RRMM expected in the third quarter of 2023
- Presented long-term follow-up data
from a multicenter IIT at ASCO 2023 Annual Meeting and EHA2023
Congress demonstrating deep and durable responses
- Among 29 treated RRMM patients,
GC012F showed 93.1% overall response rate (ORR), 82.8% stringent
complete response (sCR) rate, 100% minimal residual disease
negativity (MRD-), and a median progression free survival (mPFS) of
38.0 months (95% CI: 11.8-NR) as of the data cutoff date April 12,
2023
FasTCAR-T GC012F in newly diagnosed
multiple myeloma (NDMM):
- Clinical data update with
additional patients and longer follow-up from ongoing IIT to be
presented in the third quarter of 2023
FasTCAR-T GC012F in B-cell non-Hodgkin’s
lymphoma (B-NHL):
- Presented updated clinical data
from an IIT at ASCO 2023 Annual Meeting and EHA2023 Congress
- Among nine treated patients and as
of the data cutoff date April 12, 2023, GC012F showed 100% ORR and
77.8% complete response (CR) rate at 3 months, and 66.7% CR rate at
6 months. All nine patients are classified as relapsed/refractory
diffuse large B-cell lymphoma (DLBCL), the most challenging subtype
of B-NHL.
FasTCAR-T
GC012F in refractory systemic lupus erythematosus
(rSLE)
- BCMA/CD19 dual-targeting design
aims to achieve more effective elimination of antibody-secreting
cells, in comparison to CD19 single-targeting CAR-T
- IIT evaluating GC012F in rSLE
underway in China
- Patient enrollment and dosing
underway
- Anticipate to share initial data in
the first half of 2024
- On track to submit US IND filing
for planned Phase 1 trial in 2023
GC007g for the
treatment of B-ALL: Allogeneic CD19-targeted CAR-T cell
therapy, derived from human leukocyte antigen (HLA) matched donor,
for the treatment of relapsed/refractory b-cell acute lymphoblastic
leukemia (r/r B-ALL) patients who failed transplant and may not be
eligible for autologous CAR-T therapy.
- Phase 1 data presented at EHA2023
Congress highlighted 100% MRD- complete response or complete
response with/without complete hematologic recovery (CR/CRi)
- Registrational Phase 2 trial
ongoing in China
SMART
CART™ GC506: 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.
- Commenced an IIT in China for GC506
in Claudin18.2 positive solid tumors
Reprioritization of Pipeline: The Company
completed a strategic review of its clinical pipeline and will
prioritize its resources on the clinical development of its most
innovative product candidates that have the best-in-class
potential, such as dual-targeting FasTCAR-T GC012F. The Company
expects to incur minimal expenses related to program
discontinuations.
PIPE Financing
On August 10, 2023,
the Company closed a private placement of 138,900,000 ordinary
shares (equivalent to 27,780,000 of the Company’s American
depositary shares (“ADSs”)) and warrants to purchase up to
44,802,870 ordinary shares (equivalent to 8,960,574 ADSs),
exercisable at the election of the investors within 24 months after
closing. The Company has received $100 million in proceeds from the
private placement of ordinary shares, and will receive up to an
additional $50 million if the warrants are fully exercised. The
financing included participation from the high-quality healthcare
investors and was led by Vivo Capital, with participation from new
and existing shareholders including Adage Capital Partners LP,
Exome Asset Management, Janus Henderson Investors, Logos Capital,
OrbiMed, Pivotal Life Sciences, RA Capital Management and TCGX,
among others. The aggregate proceeds from this financing, combined
with current cash, cash equivalents, is expected to be sufficient
to fund the current operating plan into the second half of
2026.
Financial
Results for Second Quarter Ended June 30, 2023
As of June 30, 2023,
the Company had RMB1,188.0 million (US$163.8 million) in cash and
cash equivalents and short-term investments. In addition, the
Company had short-term borrowings and current portion of long-term
borrowings of RMB103.0 million (US$14.2 million) and long-term
borrowings of RMB40.0 million (US$5.5 million).
Net loss attributable
to ordinary shareholders for the three months ended June 30, 2023
was RMB146.9 million (US$20.3 million), compared to RMB146.3
million for the corresponding prior year period.
Research and Development Expenses
Research and
development expenses for the three months ended June 30, 2023 were
RMB103.8 million (US$14.3 million), compared to RMB117.1 million in
the corresponding prior year period. The decrease was primarily due
to the decreased spending on research, development, clinical trials
and payroll.
Administrative Expenses
Administrative
expenses for the three months ended June 30, 2023 were RMB37.4
million (US$5.2 million), compared to RMB28.8 million for the
corresponding prior year period. The increase was primarily driven
by an increase in professional service fees as well as an increase
in share-based compensation expenses.
As of June 30, 2023, 340,655,139 ordinary shares
(excluding 22,735,527 ordinary shares issued to depositary bank as
of June 30, 2023, for bulk issuance of ADSs reserved for future
issuances upon the exercise or vesting of awards granted under our
share incentive plans), par value of US$0.0001 per share, were
issued and outstanding. As of June 30, 2023, 19,529,166 options
were granted and 14,852,668 options were outstanding, and 5,038,056
restricted share units (“RSUs”) were granted under our employee
stock option plan.
Immediately following the close of private
placement transaction, 479,555,139 ordinary shares, par value of
US$0.0001 per share, were issued and outstanding. Each of our ADS
represents five ordinary shares.
Conference Call and Webcast
Details:Monday, August 14, 2023 @ 8:00 am ETInvestor
domestic dial-in: (800) 715-9871 Investor international dial-in:
(646) 307-1963Conference ID: 2527305
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
GC012FGC012F is Gracell's FasTCAR-enabled BCMA/CD19
dual-targeting autologous CAR-T cell therapy, which aims to
transform cancer and autoimmune disease treatment by driving fast,
deep and durable responses with improved safety profile. GC102F is
currently being evaluated in clinical studies in multiple
hematological cancers as well as autoimmune diseases, and has
demonstrated a consistently strong efficacy and safety profile.
Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the
treatment of relapsed/refractory multiple myeloma in the US and
expects to initiate a Phase 1/2 clinical trial in China. Gracell
has also commenced an investigator-initiated trial evaluating
GC012F for the treatment of refractory systemic lupus erythematosus
(rSLE).
About
FasTCARIntroduced in 2017, FasTCAR is Gracell's
revolutionary next-day autologous CAR-T cell manufacturing
platform. FasTCAR is designed to lead the next generation of cell
therapy for cancer and autoimmune diseases, and improve outcomes
for patients by enhancing CAR-T cell fitness, reducing costs, and
enabling more patients to access critical CAR-T treatment. FasTCAR
drastically shortens cell production from weeks to overnight,
potentially reducing patient wait times and probability for their
disease to progress. Furthermore, FasTCAR T-cells appear younger
than traditional CAR-T cells, making them more proliferative and
effective at killing cancer cells. In November 2022, FasTCAR was
named the winner of the Biotech Innovation category of the 2022
Fierce Life Sciences Innovation Awards for its ability to address
major industry obstacles.
About Gracell Gracell
Biotechnologies Inc. (“Gracell”) is a global clinical-stage
biopharmaceutical company dedicated to discovering and developing
breakthrough cell therapies for the treatment of cancers and
autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR
technology platforms and SMART CAR™ 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 and autoimmune diseases. The lead candidate
BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being
evaluated in the clinical studies for the treatment of multiple
myeloma, B-NHL and systemic lupus erythematosus (SLE). For more
information on Gracell, please visit www.gracellbio.com and follow
@GracellBio on LinkedIn.
Exchange Rate
InformationThis 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 7.2513 to US$1.00, the rate in effect as of June 30, 2023
published by the Federal Reserve Board.
Cautionary
Note Regarding Forward-Looking StatementsStatements in
this press release about future expectations, plans, and prospects,
as well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements”
within the meaning of The Private Securities Litigation Reform Act
of 1995. The words “anticipate,” “look forward to,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
factors discussed in the section entitled “Risk Factors” in
Gracell’s most recent annual report on Form 20-F, as well as
discussions of potential risks, uncertainties, and other important
factors in Gracell’s subsequent filings with the U.S. Securities
and Exchange Commission. Any forward-looking statements contained
in this press release speak only as of the date hereof. Gracell
specifically disclaims any obligation to update any forward-looking
statement, whether due to new information, future events, or
otherwise. Readers should not rely upon the information on this
page as current or accurate after its publication date.
Unaudited Condensed Consolidated Balance
Sheets(All amounts in thousands, except for share
and per share data)
|
|
As of December 31, |
|
As of June 30, |
|
|
2022 |
|
2023 |
|
|
RMB |
|
RMB |
|
US$ |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
1,454,645 |
|
|
1,184,430 |
|
|
163,340 |
|
Short-term investments |
|
3,559 |
|
|
3,574 |
|
|
493 |
|
Prepayments and other current assets |
|
37,551 |
|
|
59,402 |
|
|
8,192 |
|
Total current assets |
|
1,495,755 |
|
|
1,247,406 |
|
|
172,025 |
|
Property, equipment and software, net |
|
123,126 |
|
|
106,698 |
|
|
14,714 |
|
Operating lease right-of-use assets |
|
21,546 |
|
|
12,896 |
|
|
1,778 |
|
Other non-current assets |
|
15,849 |
|
|
10,886 |
|
|
1,501 |
|
TOTAL ASSETS |
|
1,656,276 |
|
|
1,377,886 |
|
|
190,018 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accruals and other current liabilities |
|
85,991 |
|
|
75,580 |
|
|
10,422 |
|
Short-term borrowings |
|
104,600 |
|
|
90,000 |
|
|
12,412 |
|
Operating lease liabilities, current |
|
17,545 |
|
|
12,472 |
|
|
1,720 |
|
Amounts due to a related party |
|
4,662 |
|
|
2,760 |
|
|
381 |
|
Current portion of long-term borrowings |
|
7,844 |
|
|
13,004 |
|
|
1,793 |
|
Total current liabilities |
|
220,642 |
|
|
193,816 |
|
|
26,728 |
|
Operating lease liabilities, non-current |
|
6,485 |
|
|
2,542 |
|
|
351 |
|
Long-term borrowings |
|
46,505 |
|
|
39,958 |
|
|
5,510 |
|
Other non-current liabilities |
|
6,879 |
|
|
4,851 |
|
|
669 |
|
TOTAL LIABILITIES |
|
280,511 |
|
|
241,167 |
|
|
33,258 |
|
Shareholders’ equity: |
|
|
|
|
|
|
Ordinary shares |
|
223 |
|
|
225 |
|
|
31 |
|
Additional paid-in capital |
|
2,927,295 |
|
|
2,942,348 |
|
|
405,768 |
|
Accumulated other comprehensive income |
|
73,528 |
|
|
118,089 |
|
|
16,285 |
|
Accumulated deficit |
|
(1,625,281 |
) |
|
(1,923,943 |
) |
|
(265,324 |
) |
Total shareholders’ equity |
|
1,375,765 |
|
|
1,136,719 |
|
|
156,760 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
1,656,276 |
|
|
1,377,886 |
|
|
190,018 |
|
Unaudited Condensed Consolidated
Statements of Comprehensive Loss(All amounts in
thousands, except for share and per share data)
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
2022 |
|
2023 |
|
2022 |
|
2023 |
|
|
RMB |
|
RMB |
|
US$ |
|
RMB |
|
RMB |
|
US$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
(117,058 |
) |
|
(103,803 |
) |
|
(14,315 |
) |
|
(238,895 |
) |
|
(241,309 |
) |
|
(33,278 |
) |
Administrative expenses |
|
(28,766 |
) |
|
(37,350 |
) |
|
(5,151 |
) |
|
(66,656 |
) |
|
(66,438 |
) |
|
(9,162 |
) |
Loss from
operations |
|
(145,824 |
) |
|
(141,153 |
) |
|
(19,466 |
) |
|
(305,551 |
) |
|
(307,747 |
) |
|
(42,440 |
) |
Interest income |
|
2,702 |
|
|
5,268 |
|
|
726 |
|
|
5,198 |
|
|
19,895 |
|
|
2,744 |
|
Interest expense |
|
(1,657 |
) |
|
(1,704 |
) |
|
(235 |
) |
|
(3,082 |
) |
|
(3,360 |
) |
|
(463 |
) |
Other income |
|
1,797 |
|
|
5,907 |
|
|
815 |
|
|
1,940 |
|
|
6,538 |
|
|
902 |
|
Foreign exchange loss, net |
|
(3,324 |
) |
|
(11,017 |
) |
|
(1,519 |
) |
|
(3,395 |
) |
|
(9,736 |
) |
|
(1,343 |
) |
Others, net |
|
1 |
|
|
(4,225 |
) |
|
(583 |
) |
|
2 |
|
|
(4,226 |
) |
|
(583 |
) |
Loss before income
tax |
|
(146,305 |
) |
|
(146,924 |
) |
|
(20,262 |
) |
|
(304,888 |
) |
|
(298,636 |
) |
|
(41,183 |
) |
Income tax expense |
|
— |
|
|
(10 |
) |
|
(1 |
) |
|
— |
|
|
(26 |
) |
|
(4 |
) |
Net loss attributable
to Gracell Biotechnologies Inc.’s ordinary
shareholders |
|
(146,305 |
) |
|
(146,934 |
) |
|
(20,263 |
) |
|
(304,888 |
) |
|
(298,662 |
) |
|
(41,187 |
) |
Other comprehensive
income |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments, net of nil tax |
|
82,028 |
|
|
62,443 |
|
|
8,611 |
|
|
75,591 |
|
|
44,561 |
|
|
6,145 |
|
Total comprehensive
loss attributable to Gracell Biotechnologies
Inc.’s ordinary shareholders |
|
(64,277 |
) |
|
(84,491 |
) |
|
(11,652 |
) |
|
(229,297 |
) |
|
(254,101 |
) |
|
(35,042 |
) |
Weighted average
number of ordinary shares used in per share
calculation: |
|
|
|
|
|
|
|
|
|
|
|
|
—Basic |
|
338,355,742 |
|
|
341,336,375 |
|
|
341,336,375 |
|
|
338,244,214 |
|
|
339,951,916 |
|
|
339,951,916 |
|
—Diluted |
|
338,355,742 |
|
|
341,336,375 |
|
|
341,336,375 |
|
|
338,244,214 |
|
|
339,951,916 |
|
|
339,951,916 |
|
Net loss per share
attributable to Gracell
Biotechnologies Inc.’s ordinary
shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
—Basic |
|
(0.43 |
) |
|
(0.43 |
) |
|
(0.06 |
) |
|
(0.90 |
) |
|
(0.88 |
) |
|
(0.12 |
) |
—Diluted |
|
(0.43 |
) |
|
(0.43 |
) |
|
(0.06 |
) |
|
(0.90 |
) |
|
(0.88 |
) |
|
(0.12 |
) |
Media contact:
Marvin Tang
marvin.tang@gracellbio.com
Investor contact:
Gracie Tong
gracie.tong@gracellbio.com
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