IN8bio Reports First Quarter 2024 Financial Results and Recent Corporate Highlights
10 May 2024 - 6:00AM
IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical
company developing innovative gamma-delta T cell therapies, today
reported financial results for the first quarter ended March 31,
2024 and recent corporate highlights.
“We continued to make significant progress
advancing our gamma-delta T cell programs in the first quarter of
2024,” said William Ho, CEO and co-founder of IN8bio. “We presented
new preclinical data on our nsCAR platform at the American
Association for Cancer Research (AACR) 2024 Annual Meeting
demonstrating its potential to target and kill various acute
myeloid leukemia (AML) cells by targeting CD33 and/or CD123, while
preserving healthy bone marrow cells. These findings reinforce our
technology’s ability to precisely target “undruggable” cancer
targets that have historically been challenging due to on-target,
off-tumor toxicity. We will provide an update from our Phase 1
study of INB-100 at the 2024 European Hematology Association (EHA)
Annual Meeting in June, including patient status and survival rate
data. We anticipate enrolling ten additional patients in an
expansion cohort at the recommended Phase 2 dose, and could
potentially submit an investigational new drug (IND) application
for a Phase 2 randomized control trial this year. In addition, at
the American Society of Clinical Oncology (ASCO) Annual Meeting, we
will provide an update on our Phase 1 INB-200 study in GBM which
generated an initial efficacy signal supporting the INB-400
trial.”
Corporate Highlights and Recent
Developments
- Presented data at AACR 2024,
supporting the potential of proprietary constructs targeting CD33
and/or CD123 for in vitro evaluation against various types of
leukemia, including AML and chronic myeloid leukemia (CML).
- Demonstrated
significant differences between cells expressing traditional
signaling chimeric antigen receptors (CARs) and those expressing
nsCAR constructs, which include a reduction in activation-induced
cell death with nsCAR constructs.
- Peer-reviewed
publication of “Adoptive Cell Therapy for High Grade Gliomas using
Simultaneous Temozolomide and Intracranial MGMT-Modified γδ T cells
Following Standard Post-Resection Chemotherapy and Radiotherapy:
Current Strategy and Future Directions” in Frontiers in
Immunology detailing IN8bio’s DeltEx Drug Resistant
Immunotherapy (DRI) as a rational therapeutic approach for newly
diagnosed GBM.
- Announced first
patient dosed in the Phase 2 autologous arm of INB-400 in patients
with newly diagnosed GBM.
Upcoming Anticipated Pipeline Milestones
and Events
- American
Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting (May
10, 2024): Upcoming oral presentation: “Healthy Donor vs
Patient Manufactured Autologous DeltEx DRI Product;
Immunophenotyping Gene Expression,” will unveil new data
highlighting the characterization of our clinical manufactured
DeltEx DRI product. The presentation will explore the impact of
manufacturing on the final cell product from healthy donors and
those manufactured from cancer patients, showcasing IN8bio’s robust
capabilities and know-how in complex cell therapy process
development and manufacturing.
-
INB-100: Report updated interim results from the
ongoing Phase 1 investigator-sponsored trial at the 2024 EHA Annual
Meeting, held June 13-16 in Madrid, Spain. In addition, we will
potentially submit an IND application for a Phase 2 registrational
trial in 2024 in the AML and myelodysplastic syndrome (MDS) patient
setting.
-
INB-200: Report interim Phase 1 long-term follow
up results in GBM at multiple medical meetings in 2024 including at
the 2024 ASCO Annual Meeting.
-
INB-400: Initiated patient dosing in the Phase 2
autologous arm of INB-400 in newly diagnosed GBM. IN8bio expects to
treat up to a total of 40 patients in arm A at multiple sites
across the United States.
First Quarter 2024 Financial
Highlights
- Research
and Development (R&D) expenses: R&D expenses were
$4.9 million, compared to $4.4 million for the comparable prior
year period. The increase was primarily due to (i) increased
personnel-related costs, including salaries and stock-based
compensation due to increased headcount and (ii) direct clinical
costs for INB-100, INB-200 and INB-400.
- General
and administrative expenses: General and administrative
expenses were $3.7 million, compared to $3.5 million for the
comparable prior year period. The increase was primarily due to
increased personnel-related costs, including stock-based
compensation and rent, offset by cost savings related to directors’
and officers’ insurance premiums and a reduction in professional
services.
- Net
loss: Net loss was $8.6 million, or $0.20 per basic and
diluted common share, compared to a net loss of $7.5 million, or
$0.30 per basic and diluted common share, for the comparable prior
year period.
- Cash position: As
of March 31, 2024, the Company had cash of $13.0 million, compared
to $21.3 million, as of December 31, 2023.
About IN8bio IN8bio is a
clinical-stage biopharmaceutical company developing gamma-delta T
cell-based immunotherapies for cancer patients. 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. The company’s lead program INB-400 is in a
Phase 2 trial in glioblastoma multiforme (GBM). Additional programs
include Phase 1 trials in solid and hematologic tumors, including
INB-200 for GBM and INB-100 for patients with hematologic
malignancies undergoing transplantation. For more information about
IN8bio, 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: IN8bio’s ability to continue advancing our gamma-delta
T-cell programs; the potential of IN8bio’s proprietary nsCAR
platform to selectively eliminate cancer cells while preserving
healthy tissue; and IN8bio’s ability to achieve anticipated
milestones, including expected presentations and data readouts from
its trials, enrollment of additional patients in its clinical
trials, advancement of clinical development plans and submission of
INDs. 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, presented by public
health crises as well as rising inflation and regulatory
developments; 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, are described in greater detail in
the section entitled “Risk Factors” in our Annual Report on Form
10-K filed with the Securities and Exchange Commission (SEC) on
March 14, 2024, 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) |
|
|
|
March 31, |
|
|
|
|
|
|
2024 |
|
|
December 31, |
|
|
|
(unaudited) |
|
|
2023 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash |
|
$ |
13,015 |
|
|
$ |
21,282 |
|
Prepaid expenses and other current assets |
|
|
2,740 |
|
|
|
3,343 |
|
Total Current Assets |
|
|
15,755 |
|
|
|
24,625 |
|
Non-current assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
3,325 |
|
|
|
3,514 |
|
Construction in progress |
|
|
203 |
|
|
|
182 |
|
Restricted cash |
|
|
256 |
|
|
|
256 |
|
Right-of-use assets - finance leases |
|
|
1,160 |
|
|
|
1,364 |
|
Right-of-use assets - operating leases |
|
|
4,530 |
|
|
|
3,513 |
|
Other non-current assets |
|
|
320 |
|
|
|
255 |
|
Total Non-Current Assets |
|
|
9,794 |
|
|
|
9,084 |
|
Total Assets |
|
$ |
25,549 |
|
|
$ |
33,709 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,413 |
|
|
$ |
924 |
|
Accrued expenses and other current liabilities |
|
|
895 |
|
|
|
2,955 |
|
Short-term finance lease liability |
|
|
680 |
|
|
|
694 |
|
Short-term operating lease liability |
|
|
856 |
|
|
|
820 |
|
Total Current Liabilities |
|
|
3,844 |
|
|
|
5,393 |
|
Long-term finance lease liability |
|
|
351 |
|
|
|
525 |
|
Long-term operating lease liability |
|
|
3,828 |
|
|
|
2,854 |
|
Total Non-Current Liabilities |
|
|
4,179 |
|
|
|
3,379 |
|
Total Liabilities |
|
|
8,023 |
|
|
|
8,772 |
|
Stockholders' Equity |
|
|
|
|
|
|
Preferred stock, par value $0.0001 per share; 10,000,000 shares
authorized at March 31, 2024 and December 31, 2023, respectively.
No shares issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, par value $0.0001 per share; 490,000,000 shares
authorized at March 31, 2024 and December 31, 2023; 43,287,325
shares issued and outstanding at March 31, 2024 and December 31,
2023 |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
117,303 |
|
|
|
116,152 |
|
Accumulated deficit |
|
|
(99,781 |
) |
|
|
(91,219 |
) |
Total Stockholders' Equity |
|
|
17,526 |
|
|
|
24,937 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
25,549 |
|
|
$ |
33,709 |
|
IN8BIO, INC. CONDENSED STATEMENTS OF
OPERATIONS (In thousands, except share and per
share data) (Unaudited) |
|
|
Three Months
EndedMarch 31, |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
4,903 |
|
|
$ |
4,385 |
|
General and administrative |
|
3,742 |
|
|
|
3,470 |
|
Total
operating expenses |
|
8,645 |
|
|
|
7,855 |
|
Interest
income |
|
83 |
|
|
|
— |
|
Other
income |
|
— |
|
|
|
330 |
|
Loss
from operations |
|
(8,562 |
) |
|
|
(7,525 |
) |
Net
loss |
$ |
(8,562 |
) |
|
$ |
(7,525 |
) |
Net loss
per share – basic and diluted |
$ |
(0.20 |
) |
|
$ |
(0.30 |
) |
Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
|
43,287,325 |
|
|
|
24,732,580 |
|
|
Corporate Contact:
IN8bio, Inc.Glenn Schulman, PharmD,
MPH203.494.7411gdschulman@IN8bio.com
Investors
Meru AdvisorsLee M. Sternlstern@meruadvisors.com
Media Contact
Kimberly HaKKH
Advisors917.291.5744kimberly.ha@kkhadvisors.com
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