IN8bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update
10 Agosto 2023 - 5:15PM
IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage
biopharmaceutical company developing innovative gamma-delta T cell
therapies, today announced financial results and operational
highlights for the second quarter ended June 30, 2023. In addition,
the Company provided an overview of recent corporate developments
through August 2023.
“We made significant clinical advancements in
our gamma-delta T cell programs in the second quarter of 2023,
sharing encouraging positive data from our INB-100 and INB-200
programs at major medical meetings as well as increasing enrollment
across our clinical pipeline,” said William Ho, CEO and co-founder
of IN8bio. “We were honored to be selected as one of only four oral
presentations and the only Phase 1 program for central nervous
system tumors at the ASCO 2023 Annual Meeting. The positive
clinical data from both of our Phase 1 trials continues to
demonstrate the potential of gamma-delta T cell therapy in
preventing relapse and ultimately prolonging survival in patients
with these devastating diseases. Our clinical programs investigate
the safety, durability and potential utility of gamma-delta T cells
as a much-needed treatment option for cancer patients. We look
forward to providing additional updates at medical meetings this
fall.”
Business Highlights and Recent Developments
- Presented positive INB-200
Phase 1 data update in GBM showing 100% of treated patients (n=8)
to date have exceeded median progression-free survival at the ASCO
2023 Annual Meeting. Results support the potential of
DeltEx drug resistant immunotherapy (DRI) to improve
progression-free survival and overall survival in patients with
newly diagnosed GBM, demonstrating that multiple doses in later
cohorts did not lead to any changes in toxicity profile. The
Company is on track to complete INB-200 Phase 1 study enrollment in
2023 with updated data expected to be presented later this
year.
- Presented new promising
preclinical data underscoring the potential of DeltEx gamma-delta T
cells to target and kill ovarian cancer cells at the ASGCT 26th
Annual Meeting. The results showcased the powerful
synergistic potential of combining gamma-delta T cells and
chemotherapy to enhance their ability to recognize and eradicate
cancer cells across a broad range of challenging cancer indications
beyond the brain and has the potential to be developed as a novel
therapy for ovarian cancer.
- Announced upcoming R&D
Day in October. The Company will be hosting an R&D Day
on Thursday, October 12, 2023 in New York City, with details to
follow.
-
Announced opening of advanced R&D facility in
Birmingham. The Company recently announced that it has
opened a new R&D facility in Birmingham, AL. Complementing the
Company’s current GMP manufacturing spaces, this facility will play
a vital role in enhancing the Company's preclinical R&D and
process development capabilities. These facilities will be
instrumental in advancing our groundbreaking pipeline of
gamma-delta T cell therapies, setting the stage for future clinical
and pipeline developments.
Second Quarter 2023 Financial Highlights
- Research and Development
expenses: R&D expenses were $4.1 million for the three
months ended June 30, 2023, compared to $3.5 million for the
comparable prior year period. The increase in R&D expenses was
primarily due to (i) contract research organization expenses
related to the initiation of INB-400, (ii) completion of additional
lentiviral vector manufacturing to support the INB-400 program and
(iii) increased personnel-related costs, including salaries,
benefits, and stock-based compensation due to increased
headcount.
- General and administrative
expenses: General and administrative expenses were $3.6
million for the three months ended June 30, 2023, compared to $3.7
million for the comparable prior year period. The decrease was
primarily due to cost savings related to D&O insurance premiums
and reductions in professional services.
- Net loss: The
Company reported a net loss of $7.7 million, or $0.27 per basic and
diluted common share, for the three months ended June 30, 2023,
compared to a net loss of $7.2 million, or $0.38 per basic and
diluted common share, for the comparable prior year period.
- Cash: As of June 30, 2023, the Company had
cash of $17.0 million, compared to $10.9 million as of March 31,
2023.
About IN8bio
IN8bio 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 is currently conducting two
investigator-initiated Phase 1 clinical trials for its lead
gamma-delta T cell product candidates: INB-200 for the treatment of
newly diagnosed glioblastoma and INB-100 for the treatment of
patients with leukemia undergoing hematopoietic stem cell
transplantation. Pursuant to a company-sponsored IND cleared by the
FDA in late 2022, the Company plans to initiate a Phase 2 clinical
trial of INB-400 for the treatment of newly diagnosed GBM in the
second half of 2023. IN8bio also has a broad portfolio of
preclinical programs focused on addressing other hematological and
solid tumor types. For more information about IN8bio and its
programs, please visit www.IN8bio.com.
Forward Looking Statements
This 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 and clinical trials and programs; the
timing of initiation, progress and scope of clinical trials; the
synergistic potential of DeltEx gamma-delta T cells and
chemotherapy to target solid tumors beyond the brain; future
results in clinical data relating to the INB-100, INB-200 and
INB-400 studies; the synergistic potential of combining gamma-delta
T cells and chemotherapy to recognize and eradicate cancer cells
across a broad range of challenging cancer indications beyond the
brain and its use as novel therapy for ovarian cancer; the timing,
initiation, and readout of clinical data from IN8bio’s clinical
trials, including expectations regarding enrollment and the timing
of data therefrom; the ability of IN8bio’s new R&D facility in
Birmingham, AL to play a vital role in enhancing the Company’s
preclinical R&D and process development capabilities; 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 May 12, 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) |
|
|
|
June 30,2023(unaudited) |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash |
|
$ |
16,993 |
|
|
$ |
18,182 |
|
Prepaid expenses and other current assets |
|
|
2,472 |
|
|
|
4,052 |
|
Total Current Assets |
|
|
19,465 |
|
|
|
22,234 |
|
Non-current assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
3,977 |
|
|
|
4,397 |
|
Construction in progress |
|
|
93 |
|
|
|
29 |
|
Restricted cash |
|
|
253 |
|
|
|
252 |
|
Right-of-use assets - finance leases |
|
|
1,817 |
|
|
|
1,691 |
|
Right-of-use assets - operating leases |
|
|
3,858 |
|
|
|
4,181 |
|
Other non-current assets |
|
|
255 |
|
|
|
255 |
|
Total Non-Current Assets |
|
|
10,253 |
|
|
|
10,805 |
|
Total Assets |
|
$ |
29,718 |
|
|
$ |
33,039 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
585 |
|
|
$ |
2,091 |
|
Accrued expenses and other current liabilities |
|
|
1,674 |
|
|
|
2,342 |
|
Short-term finance lease liability |
|
|
765 |
|
|
|
682 |
|
Short-term operating lease liability |
|
|
757 |
|
|
|
707 |
|
Total Current Liabilities |
|
|
3,781 |
|
|
|
5,822 |
|
Long-term finance lease liability |
|
|
861 |
|
|
|
811 |
|
Long-term operating lease liability |
|
|
3,277 |
|
|
|
3,674 |
|
Total Non-Current Liabilities |
|
|
4,138 |
|
|
|
4,485 |
|
Total Liabilities |
|
|
7,919 |
|
|
|
10,307 |
|
Stockholders'
Equity |
|
|
|
|
|
|
Preferred stock, par value $0.0001 per share; 10,000,000 shares
authorized at June 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 June 30, 2023 and December 31, 2022; 30,606,119 and
24,545,157 shares issued and outstanding at June 30, 2023 and
December 31, 2022, respectively |
|
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
98,247 |
|
|
|
83,941 |
|
Accumulated deficit |
|
|
(76,452 |
) |
|
|
(61,212 |
) |
Total Stockholders' Equity |
|
|
21,799 |
|
|
|
22,732 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
29,718 |
|
|
$ |
33,039 |
|
|
IN8BIO, INC. CONDENSED STATEMENTS OF
OPERATIONS (In thousands, except share and per
share data) (Unaudited) |
|
|
Three Months
EndedJune 30, |
|
|
Six Months
EndedJune 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,134 |
|
|
$ |
3,504 |
|
|
$ |
8,519 |
|
|
$ |
5,885 |
|
General and administrative |
|
3,581 |
|
|
|
3,675 |
|
|
|
7,051 |
|
|
|
7,439 |
|
Total operating expenses |
|
7,715 |
|
|
|
7,179 |
|
|
|
15,570 |
|
|
|
13,324 |
|
Other income |
|
— |
|
|
|
— |
|
|
|
330 |
|
|
|
— |
|
Loss from operations |
|
(7,715 |
) |
|
|
(7,179 |
) |
|
|
(15,240 |
) |
|
|
(13,324 |
) |
Net loss |
$ |
(7,715 |
) |
|
$ |
(7,179 |
) |
|
$ |
(15,240 |
) |
|
$ |
(13,324 |
) |
Net loss per share – basic and
diluted |
$ |
(0.27 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.71 |
) |
Weighted-average number of
shares used in computing net loss per common share, basic and
diluted |
|
28,472,346 |
|
|
|
18,828,680 |
|
|
|
26,612,794 |
|
|
|
18,814,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company Contact:IN8bio, Inc.Patrick McCall+ 1
646.600.6GDT (6438)info@IN8bio.com
Investors & Media:Argot
PartnersIN8bio@argotpartners.com
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