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 second quarter
of 2023.
“Our previously announced strategic
prioritization of our injectable modality (AIM INJ) underscores our
commitment to delivering on the significant potential of our
artificial antigen-presenting cell (aAPC) nanoparticles to drive
antigen-specific T cell function beyond cell therapy approaches and
oncology. In our clinical trials with our adoptive cell therapy, we
have demonstrated the ability to expand AML tumor-specific T cells
with combined memory and effector functions and have observed
clinical responses. Furthermore, our collaborations have generated
preclinical data that highlights the potential to drive response in
solid tumor indications, as well as non-malignant immunology
diseases such as MS and SLE,” said Kristi Jones, NexImmune’s
CEO.
“Our cells exhibit potential superior potency
and durability in preclinical models, combining a low dose of AIM
multi-tumor expanded T cells with low doses of T-cell engaging
bispecific agents, and showing synergistic tumor killing. We
believe that these data support the importance of combining a “fit”
multi-tumor specific T cell approach with other T cell
immuno-oncology mechanisms and represent a unique opportunity to
transform treatment paradigms, especially in solid tumors.”
“We remain excited about advancing the
injectable programs to the clinic and we are encouraged by initial
dialogue with the FDA. We believe that the ability to bypass the
host dendritic cell and directly engage T cells in the body
provides the potential for greater specific T cell
responses. Preclinical data to date has been consistent
across modalities in the ability to selectively activate and expand
important tumor specific T cells with cancer cell killing capacity.
In autoimmune disease models, our injectable nanoparticles have
been shown to selectively reduce and suppress the disease-causing T
cells that reside in the lymph node and target organs in diseases
such as T1D. Several manufacturing components have already been
produced and process transfer plans are underway. We also continue
to advance our Class II approach designed to address diseases like
rheumatoid arthritis (RA) and celiac disease.”
“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 immunotherapies and novel
combinations and look forward to providing updates in the
future.”
Select Second Quarter 2023 Clinical and Business
Highlights
Clinical and Preclinical Updates
AIM INJ, an injectable “Off-the-shelf”
Antigen-Specific Immunotherapy, and Other Preclinical Research
- Initiated multiple
preclinical studies to evaluate NEXI-100 as a monotherapy and in
combination with other cancer immunotherapies to support the
Company’s oncology program.
- 2023 FOCIS Annual
Meeting poster presentation reported AIM nanoparticle expansion of
EBV-specific T-cell from healthy donors and patients with MS
revealed a functional defect in the EBV response of MS patients to
select antigen peptide targets, which may be a contributing factor
in the pathogenesis of MS as well as other EBV related
non-malignant diseases such as SLE.
- In partnership with
Yale University Professor Kevan Herold and the Juvenile Diabetes
Research Fund (JDRF), evaluation of AIM injectable nanoparticles in
type 1 diabetes (T1D) confirmed their ability to drive T cell
function in vivo as evidenced by a significant delay in the onset
of spontaneous T1D that is associated with a reduction in T1D
inducing memory T cells in pancreatic lymph nodes and the pancreas.
Future experiments will be conducted to test the addition of
suppressive and apoptotic 2nd signals to the AIM nanoparticles in
addition to therapeutic combination approaches with anti-CD3
agents.
- Continued to
advance neo-antigen our melanoma research collaboration with NYU
Langone’s Perlmutter Cancer Center.
- Continued to work
in other areas of autoimmune diseases, including vitiligo, MS,
HTLV-1-associated myelopathy and others.
NEXI-001 Relapsed Refractory AML Post
Allo-HSCT
- A marked increase
in antigen-specific cells was observed with increasing dose levels,
consistent with a dose response observation. The persistence of
antigen-specific T-cells with phenotypes associated with anti-tumor
effect and immunologic memory was consistently observed in blood
and bone marrow.
- Phase 1 data
reported at ASCO 2023 shows NEXI-001 is well tolerated with a
favorable safety profile. An immunologic and clinical dose
responses were observed. Since ASCO, the clinical response observed
in the Cohort 3 patient with poor prognosis extramedullary disease
who received the highest cell dose tested (200M x 3, Cycle 1 only)
has now been maintained up to nine months. As of the most recent
follow-up, the patient remains asymptomatic with no evidence of
disease and continues to be monitored.
Manufacturing and Regulatory:
- Transitioning the
IND engine capability: Established ACT cell therapy and
nanoparticle platform manufacturing to enable IND engine in blood
and solid tumor indications. The Company is proactively
transitioning this approach to the injectable program.
- Preparing to
manufacture clinical material for the planned injectable IND:
Completed clinical protein production, selected polymer vendor and
the transfer activities to our CDMO are underway to support the
planned submission of an IND for NEXI-101 (injectable) in
2H2024.
Select Second Quarter 2023 Financial
Highlights
Cash and cash equivalents for the Company as of
June 30, 2023 were $16.3 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 $4.9
million in the second quarter of 2023, compared to $11.8 million
for the same period in the prior year. The decrease of $6.9 million
was due primarily to the completion of preclinical manufacturing
work, pausing of clinical trials, and reduction in
personnel-related expenses resulting from terminations.
General and administrative expenses were $2.9
million, compared to $4.1 million for the same period in the prior
year. The decrease was primarily due to decreases in legal and
other administrative fees expenses and in personnel-related
expenses.
Net loss, according to U.S. generally accepted
accounting principles in the, or GAAP, was $7.6 million for the
quarter, or a basic and diluted GAAP net loss per share of $0.29.
This compares to a net loss of $15.9 million, or a basic and
diluted GAAP net loss per share of $0.69, 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 and six months ended June 30, 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; the expectation
of submitting an IND for NEXI-101 (injectable) in 2024; 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
|
June 30,2023 |
|
December 31,2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
16,281,020 |
|
|
$ |
34,642,340 |
|
Restricted cash |
|
55,000 |
|
|
|
55,000 |
|
Prepaid expenses and other current assets |
|
2,163,990 |
|
|
|
2,671,411 |
|
Total current assets |
|
18,500,010 |
|
|
|
37,368,751 |
|
Property and equipment,
net |
|
3,970,516 |
|
|
|
4,459,071 |
|
Operating lease right-of-use
assets |
|
703,217 |
|
|
|
967,032 |
|
Other non-current assets |
|
300,205 |
|
|
|
264,970 |
|
Total assets |
$ |
23,473,948 |
|
|
$ |
43,059,824 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
582,510 |
|
|
$ |
2,377,374 |
|
Accrued expenses |
|
5,139,784 |
|
|
|
7,357,153 |
|
Operating lease liabilities, current |
|
545,285 |
|
|
|
599,047 |
|
Total current liabilities |
|
6,267,579 |
|
|
|
10,333,574 |
|
Operating lease liabilities,
net of current portion |
|
203,887 |
|
|
|
425,766 |
|
Total liabilities |
|
6,471,466 |
|
|
|
10,759,340 |
|
Commitments and
contingencies |
|
|
|
Stockholders’
equity |
|
|
|
Common Stock, $0.0001 par value, 250,000,000 shares authorized as
of June 30, 2023 and December 31, 2022; 26,078,451 shares
issued and outstanding as of June 30, 2023 and
December 31, 2022 |
|
2,608 |
|
|
|
2,608 |
|
Additional paid-in-capital |
|
224,381,109 |
|
|
|
222,547,530 |
|
Accumulated deficit |
|
(207,381,235 |
) |
|
|
(190,249,654 |
) |
Total stockholders’ equity |
|
17,002,482 |
|
|
|
32,300,484 |
|
Total liabilities and stockholders’
equity |
$ |
23,473,948 |
|
|
$ |
43,059,824 |
|
|
|
|
|
|
|
|
|
NEXIMMUNE, INC.
STATEMENTS OF
OPERATIONS(unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
4,880,338 |
|
|
|
11,837,519 |
|
|
|
11,004,382 |
|
|
|
22,286,362 |
|
General and administrative |
|
2,904,321 |
|
|
|
4,088,445 |
|
|
|
6,605,686 |
|
|
|
8,693,124 |
|
Total operating expenses |
|
7,784,659 |
|
|
|
15,925,964 |
|
|
|
17,610,068 |
|
|
|
30,979,486 |
|
Loss from
operations |
|
(7,784,659 |
) |
|
|
(15,925,964 |
) |
|
|
(17,610,068 |
) |
|
|
(30,979,486 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest income |
|
223,321 |
|
|
|
84,221 |
|
|
|
498,059 |
|
|
|
117,314 |
|
Other expense |
|
(5,166 |
) |
|
|
(19,046 |
) |
|
|
(19,572 |
) |
|
|
(21,622 |
) |
Other income, net |
|
218,155 |
|
|
|
65,175 |
|
|
|
478,487 |
|
|
|
95,692 |
|
Net Loss |
$ |
(7,566,504 |
) |
|
$ |
(15,860,789 |
) |
|
$ |
(17,131,581 |
) |
|
$ |
(30,883,794 |
) |
Basic and diluted net loss attributable to common stockholders per
common share |
$ |
(0.29 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.35 |
) |
Basic and diluted weighted-average number of common shares
outstanding |
|
26,078,451 |
|
|
|
22,871,369 |
|
|
|
26,078,451 |
|
|
|
22,854,311 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STATEMENTS OF COMPREHENSIVE
LOSS(unaudited)
|
Three Months Ended March 31, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
$ |
(7,566,504 |
) |
|
$ |
(15,860,789 |
) |
|
$ |
(17,131,581 |
) |
|
$ |
(30,883,794 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale marketable securities,
net of tax |
|
— |
|
|
|
11,243 |
|
|
|
— |
|
|
|
(12,347 |
) |
Comprehensive
loss |
$ |
(7,566,504 |
) |
|
$ |
(15,849,546 |
) |
|
$ |
(17,131,581 |
) |
|
$ |
(30,896,141 |
) |
NexImmune (NASDAQ:NEXI)
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NexImmune (NASDAQ:NEXI)
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