On track to enroll first patient in Phase 1/2
clinical trial of GPH101 for sickle cell disease in the second half
of 2021
Expanded leadership team with hiring of CSO and
three new appointments to board of directors
Completed upsized initial public offering of
common stock, raising $273.7 million in gross proceeds
Graphite Bio, Inc. (Nasdaq: GRPH), a clinical-stage,
next-generation gene editing company harnessing high-efficiency
precision gene correction to treat or cure serious diseases, today
reported recent business progress and second quarter 2021 financial
results.
“This has been a transformational period for Graphite Bio as we
advance our next-generation gene editing platform to precisely find
and replace any gene in the genome. We have built an outstanding
team of experienced industry leaders and, with our recent initial
public offering, are well-resourced to advance our pipeline into
clinical development, led by GPH101, a highly differentiated gene
correction approach for sickle cell disease,” said Josh Lehrer,
M.Phil., M.D., chief executive officer of Graphite Bio. “We are
focused on executing on our mission to develop potential one-time
cures for patients who have a wide range of serious and
life-threatening diseases, starting with sickle cell. We remain on
track to enroll the first patient in our Phase 1/2 clinical trial
of GPH101 in the second half of 2021, with initial proof-of-concept
data expected by the end of 2022.”
Recent Highlights
- Completed an upsized initial public offering (IPO) of
16,100,000 shares of common stock, including full exercise of the
underwriters’ option to purchase additional shares, resulting in
aggregate gross proceeds of $273.7 million, before deducting
underwriting discounts and commissions and other offering
expenses.
- Expanded the company’s executive team with the hiring of Jane
Grogan, Ph.D., a renowned scientific leader and drug developer in
the fields of immunology, oncology and cell therapy, as chief
scientific officer. Dr. Grogan leads the company’s research and
early development efforts, including the company’s strategy to
combine its gene editing technology with novel non-genotoxic
hematopoietic stem cell-targeted conditioning regimens.
- Appointed to the company’s board of directors Dr. Kristen Hege,
Smital Shah and Dr. Jo Viney, all experienced biopharma executives
with decades of scientific and business leadership expertise.
- Exclusively licensed patent rights to high fidelity Cas9, an
engineered version of Cas9 with significantly reduced off-target
activity, including a 30-fold reduction in off-target cleavage for
the GPH101 program.
Second Quarter Financial Highlights
- Cash, Cash Equivalents and Restricted Cash: As of June
30, 2021, cash, cash equivalents and restricted cash totaled $382.1
million, which includes approximately $219.5 million in net
proceeds from the company’s June 2021 upsized IPO. An additional
amount of approximately $31.9 million in net proceeds from the full
exercise of the underwriters’ option to purchase additional shares,
which closed on July 2, will be reflected in the company’s third
quarter financial results.
- R&D Expenses: Research and development expenses were
$12.7 million for the second quarter of 2021, which includes $0.6
million in stock-based compensation expense.
- G&A Expenses: General and administrative expenses
were $4.9 million for the second quarter of 2021, which includes
$1.4 million in stock-based compensation expense.
- Net Loss: Net loss was $17.5 million, or $3.45 per basic
and diluted share, for the quarter ended June 30, 2021.
About Graphite Bio
Graphite Bio is a clinical-stage, next-generation gene editing
company harnessing high efficiency precision gene correction to
develop a new class of therapies to potentially cure a wide range
of serious and life-threatening diseases. Graphite Bio is
pioneering a precision gene editing platform that could enable a
variety of applications to transform human health and achieve one
of medicine’s most elusive goals: to precisely “find & replace”
any gene in the genome. Graphite Bio’s platform allows it to
precisely correct mutations, replace entire disease-causing genes
with normal genes, or insert new genes into predetermined, safe
locations. The company was co-founded by academic pioneers in the
fields of gene editing and gene therapy, including Maria Grazia
Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.
Forward-Looking Statements
Statements we make in this press release may include statements
which are not historical facts and are considered forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”).
These statements may be identified by words such as “aims,”
“anticipates,” “believes,” “could,” “estimates,” “expects,”
“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,”
“potential,” “seeks,” “will,” and variations of these words or
similar expressions that are intended to identify forward-looking
statements. Any such statements in this press release that are not
statements of historical fact, including statements regarding the
clinical and therapeutic potential of our gene editing platform and
our product candidates, and the timing for enrollment of the first
patient in our Phase 1/2 clinical trial of GPH101 and the
availability of initial proof-of-concept data, may be deemed to be
forward-looking statements. We intend these forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the
Securities Act and Section 21E of the Exchange Act and are making
this statement for purposes of complying with those safe harbor
provisions.
Any forward-looking statements in this press release are based
on Graphite Bio’s current expectations, estimates and projections
only as of the date of this release and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements, including the risk that we may
encounter delays in patient enrollment and in the initiation,
conduct and completion of our planned clinical trials. These risks
concerning Graphite Bio’s programs and operations are described in
additional detail in its final prospectus for the initial public
offering, which was filed with the SEC on June 28, 2021. Graphite
Bio explicitly disclaims any obligation to update any
forward-looking statements except to the extent required by
law.
GRAPHITE BIO, INC.
Condensed Statements of
Operations
(Unaudited)
(In thousands, except share
and per share data)
Three Months Ended
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Operating expenses*:
Research and development
$
12,667
$
423
$
18,044
$
423
General and administrative
4,866
869
8,857
990
Total operating expenses
17,533
1,292
26,901
1,413
Loss from operations
(17,533
)
(1,292
)
(26,901
)
(1,413
)
Other income (expense), net:
Other income (expense), net:
4
-
4
-
Related party convertible note interest
expense
-
(20
)
-
(40
)
Change in fair value of the Series A
redeemable convertible preferred stock tranche liability
-
-
(10,341
)
-
Total other income (expense), net
4
(20
)
(10,337
)
(40
)
Net loss and comprehensive loss
$
(17,529
)
$
(1,312
)
$
(37,238
)
$
(1,453
)
Net loss per share attributable to common
stockholders - basic and diluted
$
(3.45
)
$
(0.56
)
$
(8.45
)
$
(1.25
)
Weighted-average shares used in computing
net loss per share attributable to common stockholders - basic and
diluted
5,087,008
2,329,402
4,405,357
1,164,700
* Includes stock-based compensation as
follows
Research and development
$
614
$
-
$
811
$
-
General and administrative
1,404
1
2,240
1
Total stock-based compensation
expense
$
2,018
$
1
$
3,051
$
1
GRAPHITE BIO, INC.
Condensed Balance
Sheets
(Unaudited)
(In thousands)
June 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
381,965
$
19,782
Restricted cash
149
35
Prepaid expenses and other current
assets
2,638
1,286
Total current assets
384,752
21,103
Property plant and equipment, net
2,343
1,461
Other assets
11
-
Total assets
$
387,106
$
22,564
Liabilities, redeemable convertible
preferred stock, and stockholders’ equity (deficit)
Current liabilities:
Accounts payable
$
4,046
$
630
Accrued compensation
723
466
Accrued expenses and other current
liabilities
3,089
1,890
Series A redeemable convertible preferred
stock tranche liability
-
29,062
Total current liabilities
7,858
32,048
Other liabilities
64
316
Total liabilities
7,922
32,364
Series A redeemable convertible preferred
stock
-
55,608
Stockholders’ equity (deficit):
Common stock
1
-
Additional paid-in capital
487,012
5,183
Accumulated deficit
(107,829
)
(70,591
)
Total stockholders’ equity (deficit)
379,184
(65,408
)
Total liabilities, redeemable convertible
preferred stock, and stockholders’ equity (deficit)
$
387,106
$
22,564
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005591/en/
Company Contact: Stephanie Yao VP, Communications and
Investor Relations 443-739-1423 syao@graphitebio.com
Investors: Stephanie Ascher Stern IR, Inc. 212-362-1200
ir@graphitebio.com Media: Christy Curran Sam Brown, Inc.
615-414-8668 media@graphitebio.com
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