NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing
a novel approach to immunotherapy designed to orchestrate a
targeted immune response by directing the function of
antigen-specific T cells in oncology, autoimmune and infectious
diseases, today reported financial results for the first quarter
2023.
“This is an exciting time for NexImmune, as we
remain focused on progressing the development of novel approaches
in the field of immunotherapy,” said Kristi Jones, NexImmune’s
CEO. “Interest in antigen specific approaches for oncology,
autoimmune disorders and infectious diseases has never been higher.
We believe our AIM INJ direct injectable nanoparticle platform
offers a unique and powerful solution to direct a multi-antigen
specific T cell response in a scalable “off-the-shelf” approach
across these disease areas. We continue to move our INJ
“off-the-shelf” lead program forward in oncology and are encouraged
by our conversations with the FDA.”
“I am also pleased that our NEXI-001 Phase 1
clinical data in cell therapy has been accepted for presentation at
ASCO and I look forward to reviewing this data, as well as the
preclinical data across oncology, autoimmune and infectious disease
areas for our “off-the-shelf” injectable this year.”
“We remain confident in the potential
therapeutic benefit of our AIM platform-based product candidates
and their ability to significantly impact the emerging, rapidly
moving field of antigen specific immuno-oncology therapies, novel
IO/IO combinations, autoimmune disorders and virally-driven
diseases.”
Select First Quarter 2023 Clinical and Business
Highlights
Clinical and Preclinical Updates
AIM INJ, Injectable “Off-the-shelf” Antigen-Specific
Immunotherapy, and Other Preclinical Research
- Initiated multiple
preclinical studies to evaluate as a monotherapy and in combination
with a checkpoint inhibitor to support the Company’s oncology
program
- Continue to
evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes
as well as other autoimmune diseases with Yale University Professor
Kevan Herold in partnership with JDRF
- Poster presented at
2023 Tandem Meetings: Transplantation & Cellular Therapy
Meetings of ASTCT and CIBMTR demonstrated evidence that AIM
multi-antigen specific cells combined with a BCMA bispecific
results in superior potency, enhanced persistence and durability in
multiple myeloma models
- Publication in
Frontiers in Medicine highlighted the potential ability of
NexImmune’s AIM platform to treat viral diseases
- Announced research
collaboration with the National Institute of Neurological Disorders
and Stroke of the National Institutes of Health, with an initial
focus on multiple sclerosis
- Announced
neo-antigen melanoma research collaboration with NYU Langone’s
Perlmutter Cancer Center
- Continued work in
other areas of autoimmune diseases; including vitiligo, multiple
sclerosis, pemphigus, HTLV-1-associated myelopathy and others
NEXI-001 Relapsed Refractory AML Post
Allo-HSCT
- Full enrollment and
dosing of the final safety cohort of NEXI-001 completed
- Plan to announce
data at ASCO 2023
- Continued to
explore opportunities to advance NEXI-001 with potential
collaborators and investigators
NEXI-003 HPV-Related Cancers
- Continued to
explore opportunities to develop this adoptive cell therapy with
external partners and collaborators and develop a corporate HPV
strategy that utilizes the AIM INJ modality
Select First Quarter 2023 Financial
Highlights
Cash and cash equivalents for the Company as of
March 31, 2023 were $22.3 million compared to $34.6 million at
December 31, 2022. Based upon current operating plans,
NexImmune expects that its existing cash and cash equivalents will
enable the Company to fund its operating and capital expenditure
requirements into the fourth quarter of 2023.
Research and development expenses were $6.1
million in the first quarter of 2023, compared to $10.4 million for
the same period in the prior year. The decrease of $4.3 million was
due primarily to the completion of preclinical manufacturing work
and the pausing of the clinical trials.
General and administrative expenses were $3.7
million, compared to $4.6 million for the same period in the prior
year. The decrease was primarily due to decreases in
personnel-related expenses and in legal and other administrative
expenses.
Net loss, according to generally accepted
accounting principles in the U.S. GAAP, was $9.6 million for the
quarter, or a basic and diluted GAAP net loss per share of $0.37.
This compares to a net loss of $15.0 million, or a basic and
diluted GAAP net loss per share of $0.66, for the same period in
the prior year.
About NexImmune
NexImmune is a clinical-stage biotechnology
company developing a novel approach to immunotherapy designed to
employ the body’s own T cells to generate a specific, potent, and
durable immune response. The backbone of NexImmune’s approach is a
proprietary Artificial Immune Modulation (AIM™) nanoparticle
technology platform. The AIM technology enables NexImmune to
construct nanoparticles that function as synthetic dendritic cells
capable of directing a specific T cell-mediated immune response.
AIM constructed nanoparticles employ natural biology to engage,
activate and expand endogenous T cells in ways that combine
anti-tumor attributes of antigen-specific precision, potency and
long-term persistence with reduced potential for off-target
toxicities. NexImmune is focused on developing injectable AIM
nanoparticle constructs and modalities for potential clinical
evaluation in oncology, autoimmune disorders and infectious
diseases.
For more information, visit www.neximmune.com.
Forward Looking Statements
This press release may contain “forward-looking”
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are based on the beliefs and assumptions
and on information currently available to management of NexImmune,
Inc. (the “Company”). All statements other than statements of
historical fact contained in this press release are forward-looking
statements, including statements concerning our results of
operations for the three months ended March 31, 2023; the
sufficiency of the Company’s current cash and cash equivalents to
fund its planned operations into the fourth quarter of 2023; the
enrollment, timing, progress, release of data from and results of
the Company’s paused clinical trials and the expectations with
respect to potential AIM INJ product candidates; the timing,
progress and release of preclinical data from our AIM INJ platform
programs and other preclinical research programs; and the utility
of prior preclinical and clinical data in determining future
clinical results. In some cases, you can identify forward-looking
statements by terminology such as “may,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of these
terms or other comparable terminology. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause the Company’s actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks and uncertainties set forth in
the “Risk Factors” section of our Annual Report on Form 10-K for
the year ended December 31, 2022 filed with the Securities and
Exchange Commission (“SEC”) on March 28, 2023, and subsequent
reports that we file with the SEC. Forward-looking statements
represent the Company’s beliefs and assumptions only as of the date
of this press release. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee future results, levels of activity,
performance or achievements. Except as required by law, the Company
assumes no obligation to publicly update any forward-looking
statements for any reason after the date of this press release to
conform any of the forward-looking statements to actual results or
to changes in its expectations.
ContactsInvestors and
Media:Chad Rubin, SVP Corporate Affairs and Investor
RelationsNexImmune, Inc.crubin@neximmune.com
NEXIMMUNE, INC.
BALANCE SHEETS
|
March 31,2023 |
|
December 31,2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
22,315,215 |
|
|
$ |
34,642,340 |
|
Restricted cash |
|
55,000 |
|
|
|
55,000 |
|
Prepaid expenses and other current assets |
|
3,034,485 |
|
|
|
2,671,411 |
|
Total current assets |
|
25,404,700 |
|
|
|
37,368,751 |
|
Property and equipment,
net |
|
4,232,655 |
|
|
|
4,459,071 |
|
Operating lease right-of-use
assets |
|
836,292 |
|
|
|
967,032 |
|
Other non-current assets |
|
190,583 |
|
|
|
264,970 |
|
Total assets |
$ |
30,664,230 |
|
|
$ |
43,059,824 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
650,568 |
|
|
$ |
2,377,374 |
|
Accrued expenses |
|
5,547,648 |
|
|
|
7,357,153 |
|
Operating lease liabilities, current |
|
587,944 |
|
|
|
599,047 |
|
Total current liabilities |
|
6,786,160 |
|
|
|
10,333,574 |
|
Operating lease liabilities,
net of current portion |
|
300,217 |
|
|
|
425,766 |
|
Total liabilities |
|
7,086,377 |
|
|
|
10,759,340 |
|
Commitments and
contingencies |
|
|
|
Stockholders’
equity |
|
|
|
Common Stock, $0.0001 par value, 250,000,000 shares authorized as
of March 31, 2023 and December 31, 2022; 26,078,451
shares issued and outstanding as of March 31, 2023 and
December 31, 2022 |
|
2,608 |
|
|
|
2,608 |
|
Additional paid-in-capital |
|
223,389,976 |
|
|
|
222,547,530 |
|
Accumulated deficit |
|
(199,814,731 |
) |
|
|
(190,249,654 |
) |
Total stockholders’ equity |
|
23,577,853 |
|
|
|
32,300,484 |
|
Total liabilities and stockholders’ equity |
$ |
30,664,230 |
|
|
$ |
43,059,824 |
|
NEXIMMUNE, INC.
STATEMENTS OF
OPERATIONS(unaudited)
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
Research and development |
|
6,124,044 |
|
|
|
10,448,843 |
|
General and administrative |
|
3,701,365 |
|
|
|
4,604,679 |
|
Total operating expenses |
|
9,825,409 |
|
|
|
15,053,522 |
|
Loss from
operations |
|
(9,825,409 |
) |
|
|
(15,053,522 |
) |
Other income
(expense): |
|
|
|
Interest income |
|
274,738 |
|
|
|
33,093 |
|
Other expense |
|
(14,406 |
) |
|
|
(2,576 |
) |
Other income, net |
|
260,332 |
|
|
|
30,517 |
|
Net Loss |
$ |
(9,565,077 |
) |
|
$ |
(15,023,005 |
) |
Basic and diluted net loss attributable to common stockholders per
common share |
$ |
(0.37 |
) |
|
$ |
(0.66 |
) |
Basic and diluted weighted-average number of common shares
outstanding |
|
26,078,451 |
|
|
|
22,836,781 |
|
STATEMENTS OF COMPREHENSIVE
LOSS(unaudited)
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Net loss |
$ |
(9,565,077 |
) |
|
$ |
(15,023,005 |
) |
Other comprehensive loss: |
|
|
|
Unrealized gain (loss) on available-for-sale marketable securities,
net of tax |
|
— |
|
|
|
(23,590 |
) |
Comprehensive
loss |
$ |
(9,565,077 |
) |
|
$ |
(15,046,595 |
) |
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