Vor Bio Reports First Quarter 2023 Financial Results and Provides Company Update
11 Maggio 2023 - 10:05PM
Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering
company, today reported financial results for the three-month
period ended March 31, 2023, and provided a business update.
“We are pleased with the progress we made during the quarter.
Our focus continues to be on actively enrolling and treating
additional patients in our VBP101 study and submission of the
VCAR33ALLO IND, which is on-track for the first half of 2023,” said
Dr. Robert Ang, Vor Bio’s President and Chief Executive Officer.
“We look forward to sharing additional data from VBP101 at EHA in
June, initiating enrollment in VBP301, and treating our first
patient with VCAR33ALLO once the IND clears.”
Corporate Updates
Trem-cel clinical trial (VBP101) continues to actively
enroll patients; next data update expected at EHA 2023
- The company plans to provide further clinical updates on
patients treated in the VBP101 study at the EHA2023 Congress, June
9-11, 2023, in Frankfurt, Germany, presented by Dr. Guenther
Koehne, MD, PhD, Deputy Director and Chief of Blood & Marrow
Transplant and Hematologic Oncology at Miami Cancer Institute of
Baptist Health South Florida.
- The study continues to see strong investigator enthusiasm with
robust enrollment.
- Additional trem-cel engraftment and hematologic protection data
updates are expected by year-end 2023.
Trem-cel is a genome-edited allogeneic hematopoietic stem cell
transplant (HSCT) that is lacking the CD33 protein. It is designed
to replace standard of care transplants for patients suffering from
acute myeloid leukemia (AML) and potentially other blood cancers.
Trem-cel has the potential to enable powerful targeted therapies in
the post-transplant setting including Mylotarg and CD33-targeted
CAR-Ts.
VCAR33ALLO IND
on-track for 1H 2023 submission to U.S. Food & Drug
Administration (FDA)
- VCAR33ALLO is planned to be studied in the VBP301 clinical
trial, which will focus on patients who have relapsed following
allogeneic stem cell transplant where T cells harvested from the
original donor are used as starting material for the drug
product.
- The majority of the planned clinical trial sites for VBP301
overlap with VBP101, which should optimize clinical trial site
initiation and enrollment.
VCAR33ALLO is a T-cell therapy derived from allogeneic healthy
donors using a chimeric antigen receptor (CAR) specifically binding
to CD33.
cGMP qualification of in-house clinical manufacturing
facility nearly complete
Current Good Manufacturing Practices (cGMP) qualification
activities at the Company’s new in-house manufacturing facility
have nearly completed, and the Company is ready to initiate
clinical manufacturing of VCAR33ALLO upon IND clearance. The
Company plans to commence trem-cel production at the in-house
facility in 2023.
Upcoming Milestones
- VBP101 data update at EHA in June 2023
- VCAR33ALLO IND submission expected in 1H 2023
- Additional trem-cel engraftment and hematologic protection data
updates expected by year-end 2023
- In-house manufacturing of trem-cel operational by year-end 2023
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $210.2 million as of March 31, 2023,
which is projected to fund operations into the first quarter of
2025.
- Research & Development (R&D)
Expenses: R&D expenses for the first quarter of
2023 were $21.9 million, compared to $15.3 million for the first
quarter of 2022. The increase in R&D expenses was primarily due
to an increase in clinical, manufacturing and consulting expenses
as a result of the ongoing trem-cel clinical trial and the
development of the VCAR33 program, an increase in personnel
expenses, and an increase in facility costs from the Company’s
laboratory and cGMP manufacturing facility expansion.
- General & Administrative (G&A)
Expenses: G&A expenses for the first quarter of
2023 were $8.5 million, compared to $7.5 million for the first
quarter of 2022. The increase in G&A expense was primarily due
to increased personnel expenses, including an increase in
stock-based compensation expense, and an increase in professional
fees.
- Net Loss: Net loss for the first quarter
of 2023 was $28.4 million, compared to $22.7 million for the first
quarter of 2022.
|
Condensed
Consolidated Balance Sheet Data (Unaudited) |
(in
thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and marketable securities |
$ |
210,200 |
|
|
$ |
230,245 |
|
Total
assets |
|
|
277,533 |
|
|
|
299,366 |
|
Total
liabilities |
|
|
47,318 |
|
|
|
48,759 |
|
Total
stockholders’ equity |
|
|
230,215 |
|
|
|
250,607 |
|
|
|
|
|
|
Condensed
Consolidated Statement of Operations (Unaudited) |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
Three Months
Ended |
|
|
March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
21,915 |
|
|
$ |
15,280 |
|
General and administrative |
|
|
8,507 |
|
|
|
7,520 |
|
Total operating expenses |
|
$ |
30,422 |
|
|
$ |
22,800 |
|
Loss from
operations |
|
$ |
(30,422 |
) |
|
$ |
(22,800 |
) |
Other
income: |
|
|
|
|
Interest income |
|
|
1,989 |
|
|
|
63 |
|
Total other income |
|
|
1,989 |
|
|
|
63 |
|
Net
loss |
|
$ |
(28,433 |
) |
|
$ |
(22,737 |
) |
|
|
|
|
|
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.61 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
66,265,703 |
|
|
|
37,293,438 |
|
|
|
|
|
|
About Vor BioVor Bio is a clinical-stage cell
and genome engineering company that aims to change the standard of
care for patients with blood cancers by engineering hematopoietic
stem cells to enable targeted therapies post-transplant. For more
information, visit: www.vorbio.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. The words “aim,”
“anticipate,” “can,” “continue,” “could,” “design,” “enable,”
“expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,”
“plan,” “potential,” “should,” “target,” “update,” “will,” “would,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Forward-looking statements in this press
release include Vor Bio’s statements regarding the potential of its
product candidates to positively impact quality of life and alter
the course of disease in the patients it seeks to treat, the timing
and pace of patient enrollment in clinical trials and the
availability of data therefrom, the timing of regulatory filings,
the expected safety profile of its product candidates, the
potential cGMP qualification of its manufacturing facility and the
success and timing of manufacturing clinical supply for its product
candidates, its intentions to use VCAR33ALLO in combination with
trem-cel as a Treatment System, the potential of trem-cel to enable
targeted therapies in the post-transplant setting including
Mylotarg and CD33-targeted CAR-Ts, its potential upcoming
milestones, its intended use of proceeds from capital raising
activities, and its cash runway and expected capital requirements.
Vor Bio may not actually achieve the plans, intentions, or
expectations disclosed in these forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in these
forward-looking statements as a result of various factors,
including: uncertainties inherent in the initiation and completion
of preclinical studies and clinical trials and clinical development
of Vor Bio’s product candidates; availability and timing of results
from preclinical studies and clinical trials; whether interim
results from a clinical trial will be predictive of the final
results of the trial or the results of future trials; expectations
for regulatory approvals to conduct trials or to market products;
the success of Vor Bio’s in-house manufacturing capabilities and
efforts; and availability of funding sufficient for its foreseeable
and unforeseeable operating expenses and capital expenditure
requirements. These and other risks are described in greater detail
under the caption “Risk Factors” included in Vor Bio’s most recent
annual or quarterly report and in other reports it has filed or may
file with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Vor Bio expressly disclaims any
obligation to update any forward-looking statements, whether
because of new information, future events or otherwise, except as
may be required by law.
Contact:Investors & MediaSarah Spencer +1
857-242-6076sspencer@vorbio.com
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