IN8bio Reports First Quarter 2022 Financial Results and Provides Corporate Update
May 12 2022 - 8:00AM
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
quarter ended March 31, 2022. In addition, the Company provided an
overview of recent corporate developments.
“Our team continues to execute and advance our programs on
multiple fronts despite these challenging times in biotech,” said
William Ho, CEO and co-founder of IN8bio. “Our Phase I clinical
trials for both DeltEx gamma-delta product candidates, INB-200 in
GBM and INB-100 in leukemia patients, continue to progress with
encouraging early data. We added key clinical and regulatory
expertise to our senior management team and we will be introducing
our iPSC derived gamma-delta T cell platform at ASGCT next week.
The IN8bio team will be disciplined with our capital and we will
use our resources to continue to accelerate the growth and momentum
in our Company.”
Business Highlights & Updates
- In January 2022, IN8bio provided a clinical update from the
Phase 1 clinical trial of its genetically modified gamma-delta T
cell therapy candidate, INB-200, in newly diagnosed GBM. In the
single ascending dose cohort 1 (n=3), all three patients showed no
dose limiting toxicities (DLTs), no cytokine release syndrome (CRS)
or neurotoxicity and demonstrated a manageable safety profile.
Cohort 2, which will receive three repeat doses of INB-200,
includes one patient who has already received all three doses
without any DLTs or significant cell therapy related adverse
events. All of the patients treated have exceeded their expected
progression-free survival (PFS) interval based on age and MGMT
status and exceeded median expected PFS of up to seven months with
encouraging trends in overall survival.
- IN8bio presented a clinical update from the ongoing Phase 1
clinical trial of INB-100, an allogeneic gamma-delta T cell
therapeutic candidate in leukemia patients undergoing hematopoietic
stem cell transplantation. All three patients treated remain in
morphologic CR with durable remissions ranging from nine to 23
months through March 2022. We observed robust immune reconstitution
in the patients including T cells, B cells and gamma-delta T cells.
INB-100’s safety profile continues to be manageable with no DLTs,
no grade 3 or greater graft vs. host disease (GvHD), no CRS and no
neurotoxicity. The data were presented at the EBMT 48th Annual
Meeting. These are encouraging results given up to 51% are expected
to relapse within a year with standard of care treatment.
- In April 2022, IN8bio announced the continued expansion of its
clinical and regulatory teams with the appointments of Urvashi
Patel, Ph.D., Vice President, Regulatory Affairs, and Stacey
Bilinski, Vice President, Clinical Operations. They bring deep
clinical and regulatory experience to the IN8bio team, from early
to late-stage development across the biotechnology and
pharmaceutical industry with more than 45 years of combined
experience. Dr. Patel has provided regulatory guidance to
biopharmaceutical companies, including WindMIL Therapeutics,
Precision for Medicine, Janssen, Elan Pharmaceuticals and
Genentech. Ms. Bilinski has initiated numerous first in-human and
early-phase clinical development programs at biopharmaceutical
companies, including Taiho Oncology, Onconova, Insmed, Amicus
Therapeutics and Covance.
Upcoming Milestones and Events
- In May 2022, IN8bio unveiled a new preclinical program focused
on developing iPSC derived gamma-delta T cells to be presented at
the ASGCT Annual Meeting, which will be held from May 16-19, 2022.
Scalable iPSC-based cellular manufacturing is designed to create
for a uniform and renewable therapeutic product available
“off-the-shelf” for patients. IN8bio will be holding an investor
event via webcast at the conference to introduce the program to the
investment community on May 17, 2022, at 6:00 p.m. EDT. A link to
the webcast will be available on the Events & Presentations
page of the Company’s website.
- IN8bio plans to submit an investigational new drug (IND)
application for a Phase 1b/2 clinical trial of INB-400 in GBM
during the second half of 2022.
Expected Upcoming Presentations
- ASGCT 25th Annual
Meeting, Washington, D.C., May 2022: introducing a new
program on “The Development of Off-the-Shelf” Manufacturing
Strategies for iPSC-Based Gamma-Delta T Cells” along with an oral
presentation by Dr. Lamb, “Off the Shelf Cell Therapies – Beyond T
Cells (Education Session) and The Next Generation of γδ T
Cell-based Therapies” by Dr. Lamb.
- Advanced Therapies Congress Live, London, May
2022: presenting “New Directions in the Treatment of Solid
Tumors with gdT Cells” by Dr. Lamb.
- Cambridge Healthcare Immuno-Oncology Therapeutic
Development,London, May 2022: presenting
“Genetically Modified gamma delta T cells in combination with
chemotherapy: now in the clinic” by Dr. Lamb
- Cell Engager summit, Boston, May 2022:
presenting “Gamma-Delta T-cells: Novel approaches to genetic
engineering and cell-type specific therapeutic applications” by Dr.
Rochlin.
- H.C. Wainwright Global Investment Conference, May
2022: Mr. Ho will participate in a fireside chat on May
25, 2022, at 2 p.m. EDT.
- American Society for Clinical Oncology (ASCO), June
2022: presenting “Phase 1 study of drug-resistant
immunotherapy (DRI) with gene-modified autologous γδ T cells in
patients with newly diagnosed glioblastoma multiforme (GBM)
receiving maintenance temozolomide (TMZ)” by Louis B. Nabors,
M.D.
- Jefferies Healthcare Conference, June 2022:
Mr. Ho will present at 1:30 p.m. EDT on Wednesday, June 8,
2022.
First Quarter 2022 Financial Highlights
- Cash position: As of March 31, 2022, the
Company had cash of $32.1 million, compared to $37.0 million as of
December 31, 2021. The decrease in cash was primarily due to cash
used by the Company in research and development and continued
operations to advance its programs.
- Research and Development (R&D) expenses:
R&D expenses were $2.4 million for the three months ended March
31, 2022, compared to $1.2 million for the comparable prior year
period. The increase in R&D expenses were primarily due to (i)
increased third-party clinical trial and IND-related activities,
(ii) contract manufacturing costs for the ongoing INB-200 clinical
trial 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 $3.8 million for the three months
ended March 31, 2022, compared to $1.1 million for the comparable
prior year period. The increase was primarily due to increased
legal expenses, insurance costs and expenses associated with
operating as a public company.
- Net loss: The Company reported a net loss
attributable to common stockholders of $6.1 million, or $0.33 per
basic and diluted common share, for the three months ended March
31, 2022, compared to a net loss attributable to common
stockholders of $3.1 million, or $0.82 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, 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. 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 trials for IN8bio’s
product candidates; the potential of IN8bio’s DeltEx platform to
discover and develop innovative product candidates, including
iPSC-derived cell therapies; and IN8bio’s ability to achieve
planned milestones, including data readouts from its trials and
plans to file an IND application. 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-K filed with the Securities and
Exchange Commission (SEC) on March 17, 2022, 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, |
|
|
|
|
|
2022 |
|
|
December 31, |
|
|
(unaudited) |
|
|
2021 |
|
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash |
|
$ |
32,107 |
|
|
$ |
37,021 |
|
Prepaid expenses and other current assets |
|
|
1,167 |
|
|
|
1,959 |
|
Total Current Assets |
|
|
33,274 |
|
|
|
38,980 |
|
Non-current assets |
|
|
|
|
Property and equipment, net |
|
|
240 |
|
|
|
97 |
|
Construction in progress |
|
|
497 |
|
|
|
403 |
|
Restricted cash |
|
|
251 |
|
|
|
251 |
|
Right of use assets - financing leases |
|
|
555 |
|
|
|
704 |
|
Right of use assets - operating leases |
|
|
1,563 |
|
|
|
1,630 |
|
Other non-current assets |
|
|
158 |
|
|
|
158 |
|
Total Non-Current Assets |
|
|
3,264 |
|
|
|
3,243 |
|
Total Assets |
|
$ |
36,538 |
|
|
$ |
42,223 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Liabilities |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
553 |
|
|
$ |
395 |
|
Accrued expenses and other current liabilities |
|
|
884 |
|
|
|
1,235 |
|
Short-term financing lease liability |
|
|
325 |
|
|
|
392 |
|
Short-term operating lease liability |
|
|
306 |
|
|
|
234 |
|
Total Current Liabilities |
|
|
2,068 |
|
|
|
2,256 |
|
Long-term financing lease liability |
|
|
201 |
|
|
|
269 |
|
Long-term operating lease liability |
|
|
1,434 |
|
|
|
1,515 |
|
Total Non-Current Liabilities |
|
|
1,635 |
|
|
|
1,784 |
|
Total Liabilities |
|
|
3,703 |
|
|
|
4,040 |
|
Commitments and
Contingencies |
|
|
|
|
Stockholders'
Equity |
|
|
|
|
Common stock, par value $0.0001 per share; 490,000,000 shares
authorized at March 31, 2022 and December 31, 2021; 18,812,267 and
18,781,242 shares issued and outstanding at March 31, 2022 and
December 31, 2021, respectively |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
71,669 |
|
|
|
70,872 |
|
Accumulated deficit |
|
|
(38,836 |
) |
|
|
(32,691 |
) |
Total Stockholders' Equity |
|
|
32,835 |
|
|
|
38,183 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
36,538 |
|
|
$ |
42,223 |
|
IN8BIO, INC. CONDENSED
STATEMENTS OF OPERATIONS (In thousands, except
share and per share data) (Unaudited)
|
|
Three Months
EndedMarch 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
2,381 |
|
|
$ |
1,245 |
|
General and administrative |
|
|
3,764 |
|
|
|
1,118 |
|
Total operating expenses |
|
|
6,145 |
|
|
|
2,363 |
|
Loss from operations |
|
|
(6,145 |
) |
|
|
(2,363 |
) |
Net loss |
|
$ |
(6,145 |
) |
|
$ |
(2,363 |
) |
Net loss attributable to common
stockholders (Note 10) |
|
$ |
(6,145 |
) |
|
$ |
(3,069 |
) |
Net loss per share attributable
to common stockholders – basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.82 |
) |
Weighted-average number of shares
used in computing net loss per common share, basic and diluted |
|
|
18,800,546 |
|
|
|
3,764,488 |
|
Company Contact:IN8bio, Inc.Kate Rochlin,
Ph.D.+ 1 646.600.6438info@IN8bio.com
Investors:Solebury TroutDavid Buck+ 1
646.378.2927dbuck@soleburytrout.com
Media:Burns McClellan, Inc.Robert Flamm, Ph.D.
/ Katie Larchrflamm@burnsmc.com / klarch@burnsmc.com
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