IN8bio Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Business Highlights
15 March 2024 - 7:00AM
IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical
company developing innovative gamma-delta T cell therapies, today
reported financial results and business highlights for the fourth
quarter and full-year ended December 31, 2023.
“IN8bio entered 2024 with significant momentum
behind the company,” said William Ho, CEO and co-founder of IN8bio.
“Despite the difficult environment in 2023, the IN8bio team
executed operationally and successfully advanced our programs. We
presented positive data across our major clinical programs in
leukemia and GBM, broadened our clinical portfolio, and
strengthened our financial position by securing funding into 1Q
2025. We presented updated data from our INB-100 study at the 65th
American Society of Hematology Annual Meeting, which was the first
time any allogeneic cellular therapy has reported sustained
efficacy and long-term cell persistence through 365 days. This
showcases the potential of gamma-delta T cells to provide long-term
durable remissions for patients with leukemia. We believe that
IN8bio is well-positioned for significant near- and long-term
catalysts as we advance our pipeline of gamma-delta T cell
therapies to potentially extend survival in some of the most
aggressive forms of cancer.”
Business Highlights and Recent
Developments
- Announced positive INB-100 data at
the 65th American Society of Hematology (ASH) Annual Meeting &
Exposition demonstrating that 100% of evaluable leukemia patients
(n=10) treated remained alive, progression-free, and in durable
complete remission (CR) as of November 3, 2023. The data showed
long-term in-vivo expansion and persistence of allogeneic
gamma-delta T cells 365 days following a single administration of
INB-100. The study demonstrated the first-ever durable persistence
of an allogeneic cellular therapy.
- Reported positive data on INB-200
at the 28th SNO Annual Meeting. All patients who completed mandated
doses surpassed a median PFS of seven months, exceeded the
standard-of-care median PFS of four to seven months, with one
patient in Cohort 2 remaining alive and progression free past 28.5
months as of October 20, 2023. In addition, most patients exceeded
the expected PFS based on their age and methylguanine-DNA
methyltransferase (MGMT) status of their tumors.
- Announced a private placement
totaling up to $46.9 million in potential gross proceeds. The
initial closing of $14.4 million is expected to support operational
execution and extended the Company’s cash runway into 1Q 2025 with
the potential for up to $32.5 million in additional capital at
increasing valuations, subject to certain conditions.
- Initiated enrollment for the Phase
2 study of INB-400 in newly diagnosed GBM.
- Announced publication in Frontiers
in Immunology on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI)
as a rational therapeutic approach to newly diagnosed glioblastoma
titled, “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.”
- Appointed Dr. Corinne Epperly,
M.D., M.P.H., an internationally recognized immuno-oncology and
cell therapy executive with 20 years of experience, to the Board of
Directors.
Upcoming Anticipated Pipeline Milestones
and Events
- INB-100: Enroll an
additional 10 patients in an expansion cohort at the recommended
Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results
at multiple medical meetings throughout 2024; potentially submit
investigational new drug (IND) application for Phase 3 randomized
control trial in 2024.
- INB-200: Report
Phase 1 long-term follow up results at multiple medical meetings in
2024.
- INB-300: Present
additional preclinical data demonstrating proof-of-concept for the
nsCAR platform targeting CD33 and CD123 at the American Association
for Cancer Research (AACR) Annual Meeting in April 2024.
- INB-400: Dose
first patient and treat up to 15 patients at multiple sites across
the United States in the Phase 2 trial in newly diagnosed GBM;
potentially submit IND for Phase 1b allogeneic gamma-delta T cell
study in relapsed GBM in 2024.
Fourth Quarter and Full Year 2023
Financial Highlights
- Research and Development
(R&D) expenses: R&D expenses were $4.5 million for
the three months ended December 31, 2023, compared to $4.0 million
for the comparable prior year period. R&D expenses were $16.8
million for the year ended December 31, 2023, compared to $14.1
million in the prior year. The increase in R&D expenses was
primarily due to increased personnel-related costs, including
salaries, benefits, and non-cash stock-based compensation due to
increased headcount, as well as increased third-party clinical
trial-related activities for the INB-100 and INB-200 programs. The
increase was partially offset by a reduction in contract research
organization expenses for INB-400 related to the IND filing in the
prior year.
- General and administrative
(G&A) expenses: G&A expenses were $3.1 million for
the three months ended December 31, 2023, compared to $3.9 million
for the comparable prior year period. G&A expenses were $13.5
million for the year ended December 31, 2023, compared to $14.5
million in the prior year. The decrease in G&A expenses 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 $7.6 million, or $0.22 per basic and
diluted common share, for the three months ended December 31, 2023,
compared to a net loss of $7.8 million, or $0.32 per basic and
diluted common share, for the comparable prior year period. For the
year ended December 31, 2023, net loss was $30.0 million, or $1.00
per basic and diluted common share, compared to a net loss of $28.5
million, or $1.36 per basic and diluted common share, for the prior
year.
- Cash position: As
of December 31, 2023, the Company had cash of $21.3 million,
compared to $18.2 million as of December 31, 2022.
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
extending IN8bio’s cash runway into January 2025; IN8bio’s ability
to receive additional capital from the December 2023 private
placement and the corresponding impact on the company’s cash
runway; IN8bio’s ability to achieve significant near- and long-term
growth; IN8bio’s ability to advance its pipeline of gamma-delta T
cell therapies to potentially extend survival in some of the most
aggressive forms of cancer; the timing of initiation, progress and
scope of clinical trials for IN8bio’s product candidates, including
INB-100, INB-200, INB-300 and 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 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 Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission (SEC) on
November 9, 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.
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IN8BIO, INC.Balance Sheets
(In thousands, except share and per share
data) |
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December 31, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets |
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Cash |
$ |
21,282 |
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$ |
18,182 |
|
Prepaid expenses and other current assets |
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3,343 |
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4,052 |
|
Total Current Assets |
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24,625 |
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22,234 |
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Non-current assets |
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Property and equipment, net |
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3,514 |
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4,397 |
|
Construction in progress |
|
182 |
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29 |
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Restricted cash |
|
256 |
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|
252 |
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Right-of-use assets - finance leases |
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1,364 |
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1,691 |
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Right-of-use assets - operating leases |
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3,513 |
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4,181 |
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Other non-current assets |
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255 |
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|
255 |
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Total Non-Current Assets |
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9,084 |
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10,805 |
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Total Assets |
$ |
33,709 |
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$ |
33,039 |
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Liabilities and
Stockholders' Equity |
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Liabilities |
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Current liabilities |
|
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Accounts payable |
$ |
924 |
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$ |
2,091 |
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Accrued expenses and other current liabilities |
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2,955 |
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2,342 |
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Short-term finance lease liability |
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694 |
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682 |
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Short-term operating lease liability |
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820 |
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|
707 |
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Total Current Liabilities |
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5,393 |
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5,822 |
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Long-term finance lease liability |
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525 |
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|
811 |
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Long-term operating lease liability |
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2,854 |
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|
3,674 |
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Total Non-Current Liabilities |
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3,379 |
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|
4,485 |
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Total Liabilities |
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8,772 |
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10,307 |
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Commitments and
Contingencies |
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Stockholders'
Equity |
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Preferred stock, par value $0.0001 per share; 10,000,000 shares
authorized at December 31, 2023 and 2022. No shares issued and
outstanding |
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— |
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— |
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Common stock, par value $0.0001 per share; 490,000,000 shares
authorized at December 31, 2023 and 2022; 43,287,325 and 24,545,157
shares issued and outstanding at December 31, 2023 and 2022,
respectively |
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4 |
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3 |
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Additional paid-in capital |
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116,152 |
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83,941 |
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Accumulated deficit |
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(91,219 |
) |
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(61,212 |
) |
Total Stockholders' Equity |
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24,937 |
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22,732 |
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Total Liabilities and Stockholders' Equity |
$ |
33,709 |
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$ |
33,039 |
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IN8BIO, INC.Statements of
Operations(In thousands, except share and per
share data) |
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Year EndedDecember 31, |
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2023 |
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2022 |
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Operating expenses: |
|
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Research and development |
$ |
16,827 |
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$ |
14,062 |
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General and administrative |
|
13,510 |
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|
14,459 |
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Total operating expenses |
|
30,337 |
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|
28,521 |
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Loss from operations |
|
(30,337 |
) |
|
|
(28,521 |
) |
Other income |
|
330 |
|
|
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— |
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Net loss |
$ |
(30,007 |
) |
|
$ |
(28,521 |
) |
Net loss per share – basic and
diluted |
$ |
(1.00 |
) |
|
$ |
(1.36 |
) |
Weighted-average number of shares
used in computing net loss per common share – basic and
diluted |
|
29,864,932 |
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20,967,955 |
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Company Contact
IN8bio, Inc.Patrick McCall+1 646.600.6GDT
(6438)info@IN8bio.com
Investors
Meru AdvisorsLee M.
Sternlstern@meruadvisors.com
Media Contact
Kimberly HaKKH
Advisors917.291.5744kimberly.ha@kkhadvisors.com
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