IN8bio Reports Third Quarter 2023 Financial Results and Provides Corporate Update
10 11월 2023 - 6:00AM
IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage
biopharmaceutical company developing innovative gamma-delta T cell
therapies, today announced financial results, operational
highlights and recent corporate developments for the third quarter
ended September 30, 2023.
“We have continued to execute and to make
impressive clinical progress across the breadth of our pipeline,
which we shared at our recent Research & Development Day,” said
William Ho, CEO and co-founder of IN8bio. “Having completed
enrollment in the dose escalation portion of the Phase 1 trial of
INB-100 in hematologic malignancies and initiated enrollment for
the Phase 2 trial of INB-400 in newly diagnosed glioblastoma, we
are making strides towards our mission of exploring the full
potential of gamma-delta T cells as a much-needed treatment option
for cancer patients. We are encouraged by the positive data we have
seen thus far and are excited to share additional clinical updates
on our INB-100 and INB-200 programs at the upcoming SNO and ASH
meetings.”
Business Highlights and Recent
Developments
- Presented two posters
reporting biologic correlative data
from the ongoing Phase 1 clinical trial of INB-200 in GBM
and preclinical data on IN8bio’s iPSC
gamma-delta T cell platform at SITC. The
data presented from the INB-200 trial demonstrate the potential of
single and repeat doses of DeltEx drug-resistant immunotherapy
(DRI) to induce T cell persistence and sustained immune responses.
Updated patient, enrollment and survival data from the ongoing
INB-200 study will be presented at the SNO Annual Meeting on
November 17, 2023. Data from IN8bio’s iPSC platform demonstrate the
ability to kill multiple cancer types including ovarian cancer,
GBM, CML and AML cell lines along with the potential to generate
billions of iPSC-derived Vδ1+ T cells.
- Completed dose escalation
in the Phase 1 Trial of INB-100 in leukemia patients and will
present clinical data at the
upcoming ASH Annual Meeting on December 11, 2023.
Enrollment in the dose escalation phase of the Phase 1 clinical
trial (NCT03533816) of INB-100 is now closed. The presentation at
ASH will highlight clinical data updating the efficacy results of
INB-100 including complete responses (CRs) and durability.
- Initiated enrollment for
the company-sponsored Phase 2 trial of INB-400 in GBM. The
Phase 2 clinical trial of INB-400 (NCT05664243), a genetically
engineered gamma-delta T cell therapy, is open for enrollment and
plans to enroll approximately 40 patients in “Arm A” of the study,
in which autologous gamma delta cells will be used to treat
patients with newly diagnosed GBM. The primary endpoint of the
study is 12-month overall survival (OS) rate, and key secondary
endpoints include tolerability, progression-free survival (PFS),
overall response rate (ORR) and time to progression (TTP). The
University of Louisville and The Cleveland Clinic are the first
clinical sites activated to enroll patients. The company will
present a poster at the SNO Annual Meeting.
- Hosted R&D Day on
October 12, 2023, highlighting IN8bio’s unique Gamma-Delta T cell
platform. The event offered the opportunity to gain Key
Opinion Leader (KOL) insights into IN8bio’s clinical programs.
Featured presentations included those from IN8bio’s management team
on gamma-delta T cells, IN8bio’s manufacturing capabilities, an
overview of the INB-100, INB-200, and INB-400 clinical programs, as
well as presentations from key oncology thought leaders Leo Luznik,
M.D., Professor of Oncology at Johns Hopkins Medicine and Michael
Bishop, M.D., Director of the David and Etta Jones Center for
Cellular Therapy at the University of Chicago, featuring the topics
of allogeneic transplantation and the challenges of leukemic
relapse. A replay of the webcast event can be found here.
Upcoming Pipeline Milestones and
Events
- INB-100:
Presenting updated Phase 1 trial clinical data from patients with
hematological malignancies undergoing HSCT at the ASH Annual
Meeting on December 11, 2023.
- INB-200: Complete
enrollment of Cohort 3 in the Phase 1 trial; will present updated
data at SNO on November 17, 2023 with longer-term follow-up at
medical meetings throughout 2024.
- INB-300: Present
additional preclinical data demonstrating proof-of-concept for the
nsCAR platform targeting CD33 and CD123 at a medical meeting in
first half of 2024.
- INB-400: Present a
poster at the SNO Annual Meeting on November 17, 2023; file
investigational new drug (IND) application for allogeneic arms
(Arms B and C) of the Phase 2 trial in newly diagnosed and relapsed
GBM in 2024.
Third Quarter 2023 Financial
Highlights
- Research and Development
expenses: Research and development expenses were $3.8
million for the three months ended September 30, 2023, compared to
$4.3 million for the comparable prior year period. The decrease was
primarily due to a reduction in contract research organization
expenses for INB-400 related to the IND filing in the prior year
period, partially offset by increased personnel-related costs,
including salaries, benefits, and non-cash stock-based compensation
due to increased headcount.
- General and administrative
expenses: General and administrative expenses were $3.4
million for the three months ended September 30, 2023, compared to
$3.1 million for the comparable prior year period. The increase was
primarily due to an increase in professional services.
- Net Loss: The
Company reported a net loss of $7.2 million, or $0.23 per basic and
diluted common share, for the three months ended September 30,
2023, compared to $7.4 million, or $0.34 per basic and diluted
common share, for the comparable prior year period.
- Cash: As of
September 30, 2023, the Company had cash of $12.9 million, compared
to $17.0 million as of June 30, 2023.
About IN8bioIN8bio is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of gamma-delta T cell product
candidates for solid and liquid tumors. Gamma-delta T cells are a
specialized population of T cells that possess unique properties,
including the ability to differentiate between healthy and diseased
tissue. IN8bio’s DeltEx platform employs allogeneic, autologous,
iPSC and genetically modified approaches to develop cell therapies,
designed to effectively identify and eradicate tumor cells.
IN8bio has initiated a company-sponsored Phase 2
trial of INB-400 in glioblastoma (GBM) at multiple centers across
the United States and has two ongoing Phase 1 trials in solid and
hematological tumors, including INB-200 for newly diagnosed GBM and
INB-100 for leukemia patients undergoing
transplantation. IN8bio also has a broad portfolio of
preclinical programs focused on addressing other hematological and
solid tumor cancers. For more information about IN8bio and its
programs, please visit www.IN8bio.com.
Forward Looking StatementsThis
press release may contain forward-looking statements made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. 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, although not all forward-looking
statements contain these words. Forward-looking statements in this
press release include, but are not limited to, statements regarding
the development and continued progress and success of our
preclinical studies and clinical trials and programs and product
candidates; the timing of initiation, progress (including as to
enrollment) and scope of clinical trials, including for INB-100,
INB-200 and INB-400; the success of gamma delta T cells as a
treatment option for patients with both solid and hematological
cancers; the timing of filing of an IND application for INB-400;
and IN8bio’s ability to achieve anticipated milestones, including
expected data readouts from its trials, enrollment of additional
patients in its clinical trials, advancement of clinical
development plans and to develop new preclinical programs. IN8bio
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: risks to site
initiation, clinical trial commencement, patient enrollment and
follow-up, as well as IN8bio’s ability to meet anticipated
deadlines and milestones; uncertainties inherent in the initiation
and completion of preclinical studies and clinical trials and
clinical development of IN8bio’s product candidates; the risk that
IN8bio may not realize the intended benefits of its DeltEx
platform; availability and timing of results from preclinical
studies and clinical trials; whether the outcomes of preclinical
studies will be predictive of clinical trial results; whether
initial or interim results from a clinical trial will be predictive
of the final results of the trial or the results of future trials;
the risk that trials and studies may be delayed and may not have
satisfactory outcomes; potential adverse effects arising from the
testing or use of IN8bio’s product candidates; expectations for
regulatory approvals to conduct trials or to market products;
IN8bio’s reliance on third parties, including licensors and
clinical research organizations; and other important factors, any
of which could cause our actual results to differ from those
contained in the forward-looking statements. These and other
factors are described in greater detail in the section entitled
“Risk Factors” in our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on August 10, 2023, as
well as in other filings IN8bio may make with the SEC in the
future. Any forward-looking statements contained in this press
release speak only as of the date hereof, and IN8bio expressly
disclaims any obligation to update any forward-looking statements
contained herein, whether because of any new information, future
events, changed circumstances or otherwise, except as otherwise
required by law.
|
IN8BIO, INC. |
CONDENSED BALANCE SHEETS |
(In thousands, except share and per share
data) |
|
|
September 30, |
|
|
|
|
|
2023 |
|
|
December 31, |
|
|
(unaudited) |
|
|
2022 |
|
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash |
$ |
12,854 |
|
|
$ |
18,182 |
|
Prepaid expenses and other current assets |
|
3,695 |
|
|
|
4,052 |
|
Total Current Assets |
|
16,549 |
|
|
|
22,234 |
|
Non-current assets |
|
|
|
|
|
Property and equipment, net |
|
3,738 |
|
|
|
4,397 |
|
Construction in progress |
|
145 |
|
|
|
29 |
|
Restricted cash |
|
254 |
|
|
|
252 |
|
Right-of-use assets - finance leases |
|
1,579 |
|
|
|
1,691 |
|
Right-of-use assets - operating leases |
|
3,688 |
|
|
|
4,181 |
|
Other non-current assets |
|
255 |
|
|
|
255 |
|
Total Non-Current Assets |
|
9,659 |
|
|
|
10,805 |
|
Total Assets |
$ |
26,208 |
|
|
$ |
33,039 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
Liabilities |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
748 |
|
|
$ |
2,091 |
|
Accrued expenses and other current liabilities |
|
2,440 |
|
|
|
2,342 |
|
Short-term finance lease liability |
|
715 |
|
|
|
682 |
|
Short-term operating lease liability |
|
783 |
|
|
|
707 |
|
Total Current Liabilities |
|
4,686 |
|
|
|
5,822 |
|
Long-term finance lease liability |
|
695 |
|
|
|
811 |
|
Long-term operating lease liability |
|
3,069 |
|
|
|
3,674 |
|
Total Non-Current Liabilities |
|
3,764 |
|
|
|
4,485 |
|
Total Liabilities |
|
8,450 |
|
|
|
10,307 |
|
Stockholders'
Equity |
|
|
|
|
|
Preferred stock, par value $0.0001 per share; 10,000,000 shares
authorized at September 30, 2023 and December 31, 2022,
respectively. No shares issued and outstanding |
|
— |
|
|
|
— |
|
Common stock, par value $0.0001 per share; 490,000,000 shares
authorized at September 30, 2023 and December 31, 2022; 31,975,929
and 24,545,157 shares issued and outstanding at September 30, 2023
and December 31, 2022, respectively |
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
101,375 |
|
|
|
83,941 |
|
Accumulated deficit |
|
(83,621 |
) |
|
|
(61,212 |
) |
Total Stockholders' Equity |
|
17,758 |
|
|
|
22,732 |
|
Total Liabilities and Stockholders' Equity |
$ |
26,208 |
|
|
$ |
33,039 |
|
|
IN8BIO, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,786 |
|
|
$ |
4,255 |
|
|
$ |
12,305 |
|
|
$ |
10,140 |
|
General and administrative |
|
3,383 |
|
|
|
3,144 |
|
|
|
10,434 |
|
|
|
10,583 |
|
Total operating expenses |
|
7,169 |
|
|
|
7,399 |
|
|
|
22,739 |
|
|
|
20,723 |
|
Other income |
|
— |
|
|
|
— |
|
|
|
330 |
|
|
|
— |
|
Loss from operations |
|
(7,169 |
) |
|
|
(7,399 |
) |
|
|
(22,409 |
) |
|
|
(20,723 |
) |
Net loss |
$ |
(7,169 |
) |
|
$ |
(7,399 |
) |
|
$ |
(22,409 |
) |
|
$ |
(20,723 |
) |
Net loss per share – basic and
diluted |
$ |
(0.23 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.05 |
) |
Weighted-average number of
shares used in computing net loss per common share, basic and
diluted |
|
31,545,783 |
|
|
|
21,661,544 |
|
|
|
28,275,193 |
|
|
|
19,774,070 |
|
Company Contact:IN8bio,
Inc.Patrick McCall+ 1 646.600.6GDT (6438)info@IN8bio.com
Investors & MediaArgot
PartnersIN8bio@argotpartners.com
IN8bio (NASDAQ:INAB)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
IN8bio (NASDAQ:INAB)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024