Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology
company pioneering a differentiated approach to treating
neurodegenerative disease and cancer through the inhibition of
SEMA4D, today announced financial results for the third quarter
ended September 30, 2023 and provided a corporate update on
progress in key programs.
Vaccinex achieved several important clinical
milestones for pepinemab in both Alzheimer’s disease and Head and
Neck Cancer.
Alzheimer’s Disease (AD):
- Completed enrollment in the randomized, double-blind,
Phase 1b/2a SIGNAL-AD trial of pepinemab in
patients with mild Alzheimer’s disease (NCT04381468), funded in
part by the Alzheimer’s Drug Discovery Foundation and by a grant
from the Alzheimer’s Association.
- Anticipate completing 12-months treatment in June 2024 at which
time we will evaluate the impact of treatment on brain metabolic
activity, a key biomarker of clinical progression in AD, as well as
treatment effects on cognition employing several validated,
clinically meaningful Alzheimer’s cognitive scales.
- An improving AD-drug development environment, based on FDA’s
recent full approval of LEQEMBI®, enables the pathway to
reimbursement and supports further investment in Alzheimer’s
Disease drug development.
- As previously reported, pepinemab has a differentiated
mechanism of action, blocking SEMA4D, which is upregulated in
neurons during stress of Alzheimer’s and Huntington’s disease and
triggers the transformation of astrocytes and microglia from normal
homeostatic functions to neuroinflammatory activity. Blockade of
SEMA4D restores healthy astrocyte and neuronal functions while
reducing neuroinflammation (Nature Medicine 2022).
- We believe that the prevalence of AD (6 million people
diagnosed with AD in the US alone) and current concerns about the
limitations of anti-Aβ amyloid antibodies would make pepinemab
attractive as a potential alternative to anti-Aβ antibodies or
possibly for use in combination with an anti-Aβ for greater
efficacy.
- The potential
impact of the AD program on Vaccinex valuation and financial
resources make this Vaccinex’s most important near-term
catalyst.
Head and Neck Cancer:
- As previously reported, analysis of interim data from the first
36 patients in the single-arm, Phase 2 KEYNOTE B-84
study (NCT04815720) evaluating pepinemab in combination
with KEYTRUDA™ in patients with recurrent or metastatic head and
neck squamous cell carcinoma (HNSCC) suggests that the combination
of pepinemab and KEYTRUDA™ resulted in an approximately 2X increase
in objective responses (ORR) and progression free survival (PFS) in
the subset of patients with hard-to-treat PD-L1-low tumors compared
to historical response rates for checkpoint monotherapy in this
population.
- Biomarker data indicate that treatment induced the formation of
highly organized lymphoid aggregates in tumor that correlate with
disease control and have previously been shown to be important for
positive response to checkpoint inhibitors.
- Vaccinex and
Merck are currently in the design stages for an expansion of the
KEYNOTE-B84 study that may extend benefits to more patients.
Recent Milestones and News
Clinical Trials in Alzheimer’s Disease
(CTAD) Conference Presentation:
In a highlighted
podium presentation at the CTAD Conference on September 28, 2023.
Vaccinex’s Senior Vice President for Clinical Development, Terrence
Fisher, PhD, described the many physiological parallels between
neurodegenerative processes in Alzheimer’s and Huntington’s disease
(HD). A key common feature is the contribution of astrocyte
activation (astrogliosis) to brain inflammation and damage.
Vaccinex scientists have demonstrated that the stress of disease in
both AD and HD leads to upregulation of SEMA4D in neurons and that
this can trigger astrocytes to switch from their normal supportive
physiological functions to inflammatory activity. This transition
is marked by release of glial fibrillary acidic protein (GFAP), a
characteristic astrocyte protein, into blood. Importantly,
treatment with pepinemab was shown to result in a significant
reduction in plasma GFAP levels in HD patients. Elevated plasma
GFAP levels have also been reported to correlate with Aβ amyloid
deposits in brain and to be associated with higher risk of dementia
and faster rates of cognitive decline in AD.
ActivMAb® Platform Technology:
The first clinical
candidate selected through use of this technology (SRF114, a fully
human monoclonal antibody targeting CCR8 for the potential
treatment of solid tumors), is in a Phase 1/2 study sponsored by
our licensee, Surface Oncology, recently acquired by Coherus
Biosciences, Inc. (transaction closed September 8, 2023). The
technology and its potential applications for drug discovery
against complex membrane protein targets including the “hard to
drug” class of membrane-associated G protein-coupled receptors
(GPCRs) and ion channels is also being utilized in multiple
Vaccinex antibody discovery collaborations with leading
biopharmaceutical companies.
Financial Results for the Three Months
Ended September 30, 2023:
Cash and Cash Equivalents and Marketable
Securities. Cash and cash equivalents and marketable
securities on September 30, 2023 were $0.1 million, as compared to
$6.4 million as of December 31, 2022.
During Q3 2023, the Company raised finances of
$1.3 million. On August 22, 2023, Vaccinex completed a Private
Placement and issued approximately 0.20 million shares1 of common
stock for aggregate proceeds of $0.7 million. Similarly, on
September 22, 2023, Vaccinex completed a Private Placement and
issued approximately 0.25 million shares of common stock for
aggregate proceeds of $0.6 million. Vaccinex (Rochester) L.L.C.,
which is majority owned and controlled by Dr. Maurice Zauderer, the
Company’s President, Chief Executive Officer, and a member of its
board of directors purchased approximately 0.14 million shares of
common stock for gross proceeds of $0.3 million.
In addition, on October 3, 2023, the Company
issued and sold to certain investors (i) 7,600,000 shares of the
Company’s common stock together with common warrants to purchase up
to 7,600,000 shares of common stock and (ii) 2,000,000 pre-funded
warrants to purchase up to 2,000,000 shares of common stock
together with common warrants to purchase up to 2,000,000 shares of
common stock, at a purchase price of $1.00 and $0.999,
respectively, for aggregate gross proceeds of $9.60
million. FCMI, which is controlled by Albert D. Frieberg,
the chairman of the Company’s board of directors, and Vaccinex
(Rochester) L.L.C. purchased 3,000,000 and 500,000 shares of our
common stock and accompanying common warrants, respectively, for an
aggregate purchase price of $3.50 million.
Finally, in Q3 2023, the Company recorded a
receivable of $0.9 million for the Employee Retention Credit. The
Company expects to receive the cash proceeds by the end of 2023 or
early Q1 2024.
Research and Development
Expenses. Research and development expenses for the
quarter ended September 30, 2023 were $4.4 million as compared to
$3.4 million for the comparable period in 2022.
The increase in research and development
expenses is primarily attributable to increased patient enrollment
in the SIGNAL-AD study and the Phase 1b/2 KEYNOTE B84 study in
HNSCC.
General and Administrative
Expenses. General and administrative expenses for the
quarter ended September 30, 2023 were $1.5 million as compared to
$1.4 million for the comparable period in 2022.
The increase was attributable to increased legal
and patent related services.
Comprehensive loss/Net loss per
share. The Comprehensive Loss and Net loss per share for
the quarter ended September 30, 2023 was $4.9 million and $(1.09)
compared to $4.8 million and $(1.67) for the comparable period in
2022.
Full financial tables are included below. For
further details on Vaccinex’s financials, refer to its Form 10-Q
filed November 13, 2023 with the S.E.C.
About PepinemabPepinemab is a
humanized IgG4 monoclonal antibody designed to block SEMA4D, which
can trigger collapse of the actin cytoskeleton and loss of
homeostatic functions of astrocytes and glial cells in the brain
and dendritic cells in immune tissue. Pepinemab has been
administered to more than 400 patients and appears to be
well-tolerated and to have a favorable safety profile.
About Vaccinex
Inc. Vaccinex, Inc. is pioneering a differentiated
approach to treating slowly progressive neurodegenerative diseases
and cancer through the inhibition of semaphorin 4D (SEMA4D). The
Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent
biological effector that it believes triggers damaging inflammation
in chronic diseases of the brain and prevents immune infiltration
into tumors. In neurodegenerative diseases, pepinemab is being
studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in
Alzheimer’s Disease, with ongoing exploration of potential Phase 3
development in Huntington’s disease. In oncology, pepinemab is
being evaluated in combination with KEYTRUDA® in the Phase
1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck
cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2
study in patients with metastatic pancreatic adenocarcinoma (PDAC).
The oncology clinical program also includes several
investigator-sponsored studies in solid tumors including breast
cancer and melanoma.
Vaccinex has global commercial and
development rights to pepinemab and is the sponsor of the
KEYNOTE-B84 study which is being performed in collaboration
with Merck Sharp & Dohme Corp, a subsidiary of Merck and
Co, Inc. Kenilworth, NJ, USA. Additional information about the
study is available at: clinicaltrials.gov.
KEYTRUDA is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co.
Inc., Kenilworth, NJ, USA.
BAVENCIO®/avelumab is co-developed and
co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer
Inc.
Forward Looking StatementsTo
the extent that statements contained in this presentation are not
descriptions of historical facts regarding Vaccinex,
Inc. (“Vaccinex,” “we,” “us,” or “our”), they are
forward-looking statements reflecting management’s current beliefs
and expectations. Such statements include, but are not limited to,
statements about our plans, expectations and objectives with
respect to the results and timing of the SIGNAL-AD clinical trial,
the pathway to reimbursement for Alzheimer treatments, the
attractiveness of pepinemab for the treatment of Alzheimer’s, the
potential to initiate a Phase 3 trial in HD, expectations and
objectives with respect to the results and timing of the
KEYNOTE-B84 clinical trial, planned interim analysis, the use and
potential benefits of pepinemab in R/M HNSCC, lung cancer,
metastatic pancreatic adenocarcinoma (PDAC) and other indications,
the expected timeline for disclosure of trial results at scientific
conferences or through publications, and other statements
identified by words such as “believes,” “being,” “may,” “will,”
“appears,” “expect,” “ongoing,” “potential,” “prevents,” “suggest”,
and similar expressions or their negatives (as well as other words
and expressions referencing future events, conditions, or
circumstances). Forward-looking statements involve substantial
risks and uncertainties that could cause the outcome of our
research and pre-clinical development programs, clinical
development programs, future results, performance, or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, uncertainties inherent in the execution, cost and
completion of preclinical studies and clinical trials, that interim
and preliminary data may not be predictive of final results and
does not ensure success in later clinical trials, uncertainties
related to regulatory approval, risks related to our dependence on
our lead product candidate pepinemab, the impact of the COVID-19
pandemic, the possible delisting of our common stock from NASDAQ if
we are unable to regain compliance with the NASDAQ listing
standards, and other matters that could affect our development
plans or the commercial potential of our product candidates. Except
as required by law, we assume no obligation to update these
forward-looking statements. For a further discussion of these and
other factors that could cause future results to differ materially
from any forward-looking statement, see the section titled “Risk
Factors” in our periodic reports filed with the Securities and
Exchange Commission (“SEC”) and the other risks and
uncertainties described in the Company’s annual year-end Form 10-K
and subsequent filings with the SEC.
Investor ContactElizabeth Evans, PhDChief
Operating Officer, Vaccinex, Inc.(585)
766-2033eevans@vaccinex.com
VACCINEX, INC. |
|
Condensed Balance Sheets (Unaudited) (in thousands,
except share and per share data) |
|
|
|
As of September 30,
2023 |
|
|
As of December 31, 2022 |
|
ASSETS |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
127 |
|
|
$ |
6,391 |
|
Accounts receivable |
|
|
933 |
|
|
|
175 |
|
Prepaid expenses and other current assets |
|
|
1,146 |
|
|
|
912 |
|
Total current assets |
|
|
2,206 |
|
|
|
7,478 |
|
Property
and equipment, net |
|
|
164 |
|
|
|
189 |
|
Operating lease right-of-use asset |
|
|
188 |
|
|
|
310 |
|
TOTAL
ASSETS |
|
$ |
2,558 |
|
|
$ |
7,977 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,225 |
|
|
$ |
1,518 |
|
Accrued expenses |
|
|
1,895 |
|
|
|
781 |
|
Current portion of long-term debt |
|
|
75 |
|
|
|
74 |
|
Operating lease liability |
|
|
167 |
|
|
|
164 |
|
Total current liabilities |
|
|
6,362 |
|
|
|
2,537 |
|
Long-term debt |
|
|
44 |
|
|
|
101 |
|
Operating lease liability, net of current portion |
|
|
21 |
|
|
|
146 |
|
TOTAL
LIABILITIES |
|
|
6,427 |
|
|
|
2,784 |
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
Common stock, par value of $0.0001 per share; 100,000,000 shares
authorized as of September 30, 2023, and December 31, 2022;
4,858,530 and 3,325,441 shares issued as of September 30, 2023 and
December 31, 2022, respectively; 4,858,473 and 3,325,384 shares
outstanding as of September 30, 2023 and December 31, 2022,
respectively |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
332,752 |
|
|
|
324,880 |
|
Treasury stock, at cost; 57 shares of common stock as of September
30, 2023 and December 31, 2022, respectively |
|
|
(11 |
) |
|
|
(11 |
) |
Accumulated deficit |
|
|
(336,610 |
) |
|
|
(319,676 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
(3,869 |
) |
|
|
5,193 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
2,558 |
|
|
$ |
7,977 |
|
The accompanying notes are an integral part of
these condensed financial statements.
VACCINEX, INC. |
|
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)(in thousands, except share and per share
data) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
20 |
|
|
$ |
50 |
|
|
$ |
570 |
|
|
$ |
50 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,355 |
|
|
|
3,429 |
|
|
|
13,217 |
|
|
|
10,238 |
|
General and administrative |
|
|
1,499 |
|
|
|
1,413 |
|
|
|
5,250 |
|
|
|
4,599 |
|
Total costs and expenses |
|
|
5,854 |
|
|
|
4,842 |
|
|
|
18,467 |
|
|
|
14,837 |
|
Loss from operations |
|
|
(5,834 |
) |
|
|
(4,792 |
) |
|
|
(17,897 |
) |
|
|
(14,787 |
) |
Interest expense |
|
|
- |
|
|
|
(1 |
) |
|
|
(1 |
) |
|
|
(2 |
) |
Other income (expense),
net |
|
|
922 |
|
|
|
34 |
|
|
|
964 |
|
|
|
52 |
|
Loss before provision for
income taxes |
|
|
(4,912 |
) |
|
|
(4,759 |
) |
|
|
(16,934 |
) |
|
|
(14,737 |
) |
Provision for income
taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss attributable to
Vaccinex, Inc. common stockholders |
|
$ |
(4,912 |
) |
|
$ |
(4,759 |
) |
|
$ |
(16,934 |
) |
|
$ |
(14,737 |
) |
Comprehensive loss |
|
$ |
(4,912 |
) |
|
$ |
(4,759 |
) |
|
$ |
(16,934 |
) |
|
$ |
(14,737 |
) |
Net loss per share
attributable to Vaccinex, Inc. common stockholders, basic and
diluted |
|
$ |
(1.09 |
) |
|
$ |
(1.67 |
) |
|
$ |
(4.28 |
) |
|
$ |
(5.34 |
) |
Weighted-average shares used
in computing net loss per share attributable to Vaccinex, Inc.
common stockholders, basic and diluted |
|
|
4,506,834 |
|
|
|
2,844,270 |
|
|
|
3,953,431 |
|
|
|
2,757,475 |
|
The accompanying notes are an integral part of
these condensed financial statements.
1 All share amounts in this release reflect the Company’s
1-for-15 reverse stock split effected September 25, 2023.
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