IN8bio Reports Third Quarter 2021 Financial Results and Provides Corporate Update
November 10 2021 - 4:15PM
IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical
company focused on the discovery and development of innovative
gamma-delta T cell therapies utilizing its DeltEx platform, today
announced financial results and operational highlights for the
third quarter ended September 30, 2021. In addition, the Company
provided an overview of recent corporate developments.
“Our IPO has provided the capital to enable us to advance our
clinical programs for INB-100 in leukemia and INB-200 in newly
diagnosed glioblastoma (GBM) and other solid tumors as well as
progress our preclinical-stage assets,” said William Ho, Chief
Executive Officer and co-founder of IN8bio. “Both of our clinical
programs continue to progress and we took the opportunity during
the required safety observation period for the allogeneic INB-100
trial to improve our manufacturing processes and overall
gamma-delta T cell yield. We look forward to the continued
advancement of our clinical and preclinical programs and to
providing updates on them in the future.”
Third Quarter Business Highlights & Corporate
Updates
- In July 2021, IN8bio appointed Emily Fairbairn and Luba
Greenwood as two independent members of the Company’s Board of
Directors. Ms. Fairbairn is currently a principal of Transcend
Partners and was co-founder and CEO of Ascend Capital. Ms.
Greenwood serves as Managing Partner of Binney Street Capital LLC,
a venture capital fund established by the Dana Farber Cancer
Institute, and as CEO of LUCA Biologics.
- In August 2021, IN8bio closed its initial public offering, in
which it issued and sold 4,000,000 shares of common stock at a
public offering price of $10.00 per share. The net proceeds to the
Company were approximately $32.3 million, after deducting
underwriting discounts, commissions and offering expenses.
- In August 2021, IN8bio completed dosing of the first cohort of
INB-100, a Phase 1 clinical trial of donor-derived allogeneic
gamma-delta T cells in leukemia patients undergoing haploidentical
hematopoietic stem cell transplant (HSCT). No severe adverse
infusion reactions, cytokine release syndrome, neurotoxicity (or
ICANS) or dose-limiting toxicities were observed. Episodes of
mild-to-moderate acute skin graft-versus-host-disease (GvHD)
responsive to standard therapy have been observed. Additional
patients will be enrolled at the first dose-level to further assess
these events and any potential relationship to the ongoing positive
clinical responses observed in the INB-100 treated patients. Skin
biopsies were consistent with the expected pathology in post-HSCT
GvHD and the vast majority of immune cell infiltration were
alpha-beta T cells. All three patients treated with INB-100
continue in remission with the first two patients beyond 18- and
16-months post-transplant, respectively. The Company continues to
expect to report initial results from the first cohort in this
Phase 1 trial in 2022, with topline results for all cohorts in
2023.
- In September 2021, IN8bio announced the peer-reviewed
publication of preclinical results that it believes provides
foundational support for the use of its DeltEx Drug Resistant
Immunotherapy (DRI) in newly diagnosed GBM. This work, published in
Scientific Reports, a Nature Portfolio journal, focused on the use
of gamma-delta T cells genetically engineered to be chemotherapy
resistant through the addition of an O6-Methylguanine-DNA
Methyltransferase (MGMT). Concurrent dosing of DRI cells with
temozolomide (TMZ) resulted in a significant improvement in
survival outcomes in mice over either monotherapy alone in both
classical and mesenchymal primary high-grade gliomas.
- In October and November 2021, the Company presented updates on
its programs at the 2021 Advanced Therapies Congress and at the
13th Annual Protein and Antibody Engineering Summit (PEGS)
Europe.
Upcoming Scientific Presentations
- 36th Annual Meeting of the Society for Immunotherapy of Cancer
(SITC), November 10 - 14, 2021.
- 26th Annual Meeting of the Society of Neuro-Oncology (SNO),
November 18 - 21, 2021.
Third Quarter 2021 Financial Highlights
- Cash position: As of September 30, 2021, the
Company had cash of $40.7 million, compared to $18.0 million as of
December 31, 2020. The increase in cash was primarily due to the
IPO proceeds, net of cash used by the Company in operations to
advance its programs and research and development.
- Research & Development (R&D) expense:
R&D expense was $1.4 million for the three months ended
September 30, 2021, compared to $1.1 million for the comparable
prior year period. The increase in R&D expense was primarily
due to increased third-party clinical trial related activities and
contract manufacturing costs for the ongoing clinical trials and
increased personnel-related costs, including salaries, benefits and
stock-based compensation.
- General and administrative expense: General
and administrative expense was $2.0 million for the three months
ended September 30, 2021, compared to $0.6 million for the
comparable prior year period. The increase was primarily due to
increased personnel costs, including salaries, benefits and
stock-based compensation and increased legal expenses in
anticipation of operating as a public company.
- Net loss: The Company reported a net loss of
$3.4 million, or $0.25 per basic and diluted common share, for the
three months ended September 30, 2021, compared to a net loss of
$1.7 million and a net loss attributable to common stockholders of
$2.2 million, or $0.60 per basic and diluted common share, for the
comparable prior year period.
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 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. IN8bio
also has a broad portfolio of preclinical programs focused on
addressing other solid tumor types. 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 timing of
initiation, progress and scope of clinical and preclinical trials
for IN8bio’s product candidates; the potential of IN8nio’s DeltEx
platform to discover and develop innovative product candidates; and
IN8bio’s ability to achieve planned milestones, including data
readouts from its trials. 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 the ongoing COVID-19 pandemic; 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 September 10, 2021, 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, |
|
|
|
|
2021 |
|
December 31, |
|
|
(unaudited) |
|
|
2020 |
|
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash |
|
$ |
40,675 |
|
|
$ |
17,994 |
|
Prepaid expenses and other current assets |
|
|
3,202 |
|
|
|
150 |
|
Total Current Assets |
|
|
43,877 |
|
|
|
18,144 |
|
Non-current assets |
|
|
|
|
Property and equipment, net |
|
|
302 |
|
|
|
186 |
|
Deferred offering costs |
|
|
— |
|
|
|
2,439 |
|
Right of use assets - financing leases |
|
|
849 |
|
|
|
— |
|
Right of use assets - operating leases |
|
|
1,697 |
|
|
|
— |
|
Other non-current assets |
|
|
409 |
|
|
|
141 |
|
Total Non-Current Assets |
|
|
3,257 |
|
|
|
2,766 |
|
Total Assets |
|
$ |
47,134 |
|
|
$ |
20,910 |
|
Liabilities, Convertible
Preferred Stock and Stockholders' Equity (Deficit) |
|
|
|
|
Liabilities |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
692 |
|
|
$ |
620 |
|
Accrued expenses and other current liabilities |
|
|
840 |
|
|
|
1,778 |
|
Short-term financing lease liability |
|
|
464 |
|
|
|
— |
|
Short-term operating lease liability |
|
|
164 |
|
|
|
— |
|
Loan payable, current |
|
|
— |
|
|
|
174 |
|
Total Current Liabilities |
|
|
2,160 |
|
|
|
2,572 |
|
Deferred rent |
|
|
— |
|
|
|
17 |
|
Long-term financing lease liability |
|
|
343 |
|
|
|
— |
|
Long-term operating lease liability |
|
|
1,593 |
|
|
|
— |
|
Total Liabilities |
|
|
4,096 |
|
|
|
2,589 |
|
Commitments and
Contingencies |
|
|
|
|
Convertible preferred stock,
Series A |
|
|
— |
|
|
|
34,900 |
|
Stockholders' Equity
(Deficit) |
|
|
|
|
Common stock, par value $0.0001
per share; 490,000,000 and 50,700,000 shares authorized at
September 30, 2021 and December 31, 2020; 18,754,553 and 3,764,488
shares issued and outstanding at September 30, 2021 and December
31, 2020, respectively |
|
|
3 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
69,877 |
|
|
|
1,458 |
|
Accumulated deficit |
|
|
(26,842 |
) |
|
|
(18,038 |
) |
Total Stockholders' Equity (Deficit) |
|
|
43,038 |
|
|
|
(16,579 |
) |
Total Liabilities, Convertible Preferred Stock and
Stockholders' Equity (Deficit) |
|
$ |
47,134 |
|
|
$ |
20,910 |
|
IN8BIO, INC. CONDENSED
STATEMENTS OF OPERATIONS (In thousands, except
share and per share data) (Unaudited)
|
|
Three Months
EndedSeptember 30, |
|
Nine Months
EndedSeptember 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,350 |
|
|
$ |
1,057 |
|
|
$ |
4,660 |
|
|
$ |
3,893 |
|
General and administrative |
|
|
2,041 |
|
|
|
624 |
|
|
|
4,144 |
|
|
|
2,353 |
|
Total operating expenses |
|
|
3,391 |
|
|
|
1,681 |
|
|
|
8,804 |
|
|
|
6,246 |
|
Loss from operations |
|
|
(3,391 |
) |
|
|
(1,681 |
) |
|
|
(8,804 |
) |
|
|
(6,246 |
) |
Net loss |
|
$ |
(3,391 |
) |
|
$ |
(1,681 |
) |
|
$ |
(8,804 |
) |
|
$ |
(6,246 |
) |
Net loss attributable to common
stockholders |
|
$ |
(3,391 |
) |
|
$ |
(2,182 |
) |
|
$ |
(8,804 |
) |
|
$ |
(7,311 |
) |
Net loss per share attributable
to common stockholders – basic and diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.26 |
) |
|
$ |
(2.14 |
) |
Weighted-average number of shares
used in computing net loss per common share, basic and diluted |
|
|
13,377,682 |
|
|
|
3,614,329 |
|
|
|
7,004,099 |
|
|
|
3,410,101 |
|
Company Contact:IN8bio, Inc.Charles Butler+1
646.600.6GDT (6438) cbutler@in8bio.com
Investors:Solebury TroutDavid Buck+ 1
646.378.2927dbuck@soleburytrout.com
Media:Burns McClellan, Inc.Robert Flamm, Ph.D.
/ Harrison Wong+1 212.213.0006 - ext. 364 /
316rflamm@burnsmc.com / hwong@burnsmc.com
IN8bio (NASDAQ:INAB)
Historical Stock Chart
From Sep 2024 to Oct 2024
IN8bio (NASDAQ:INAB)
Historical Stock Chart
From Oct 2023 to Oct 2024