LAVA Therapeutics Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results
March 24 2022 - 6:30AM
LAVA Therapeutics N.V. (Nasdaq: LVTX), an immuno-oncology company
focused on developing its proprietary Gammabody™ platform of
bispecific gamma delta T cell engagers to transform the treatment
of cancer, today announced recent corporate highlights and
financial results for the fourth quarter and year ended December
31, 2021.
“I am incredibly proud of our LAVA team and the
steady advancements we’ve made in the continued development of our
Gammabody™ pipeline, despite the challenging times of the last
year,” said Stephen Hurly, president and chief executive officer.
“With the encouraging LAVA-051 initial safety and pharmacodynamic
observations and the LAVA-1207 study now actively recruiting
patients, we are focused on execution and delivering potential
product and platform-validating milestones this year and preparing
our early-stage Gammabody™ pipeline for the clinic. We remain
focused on our mission to efficiently develop transformative
treatments for those suffering from cancer.”
Recent Business and Pipeline
Highlights
LAVA-051 Shows Encouraging Initial
Safety and Pharmacodynamic Observations: In March 2022,
LAVA announced interim data from the first three single patient
cohorts of the Phase 1 dose escalation portion of its Phase 1/2a
clinical trial, which we believe demonstrated that the doses of
LAVA-051 used in these initial cohorts were safe and well-tolerated
with no dose limiting toxicities or cytokine release syndrome
observed. Per the study protocol, the cohort three dose was
33-times that of the cohort one dose. Vγ9Vδ2 (Vgamma9 Vdelta2) T
cell receptor occupancy of LAVA-051 increased with LAVA-051 dose
increases and peripheral blood Vγ9Vδ2 T cells also expressed higher
levels of activation markers after LAVA-051 dosing. One patient
with chronic lymphocytic leukemia (CLL) experienced multiple
enlarged tender diseased lymph nodes one week after first dosing
that subsequently regressed, reminiscent of tumor flare. Dosing in
the study is continuing, with subsequent cohorts planned to enroll
at least three patients per cohort. Additional data from the Phase
1 dose escalation phase of the trial is expected in the second
quarter of 2022 and data from the Phase 2a expansion cohorts are
expected in the second half of 2022.
The Phase 1/2a clinical trial (NCT04887259) is
currently evaluating LAVA-051 in patients with relapsed or
refractory chronic lymphocytic leukemia (CLL) and multiple myeloma
(MM). Later in the trial, LAVA will also include patients with
acute myeloid leukemia (AML). The trial is designed to evaluate the
safety, tolerability, pharmacokinetics, pharmacodynamics,
immunogenicity and preliminary antitumor activity of LAVA-051. In
October 2021, the company announced that the U.S. Food and Drug
Administration (FDA) granted orphan drug designation to LAVA-051
for the treatment of CLL.
Enrollment in LAVA-1207 Phase 1/2a Trial
Underway: In February 2022, LAVA announced it had
initiated dosing in the Company’s open-label, multi-center, Phase
1/2a clinical trial evaluating LAVA-1207 in patients with
metastatic castration-resistant prostate cancer (mCRPC) and
enrollment is ongoing. LAVA-1207 is a Gammabody™ that conditionally
activates Vγ9Vδ2 T cells upon crosslinking to prostate-specific
membrane antigen (PSMA) to trigger the potent and preferential
killing of PSMA-positive tumor cells. The trial is designed to
evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, immunogenicity and preliminary antitumor activity
of LAVA-1207 in patients with mCRPC. The Phase 1 dose-escalation
phase of the study will determine the recommended Phase 2
dose/schedule to be used in the subsequent Phase 2a expansion
cohort to confirm safety and tolerability of LAVA-1207 in mCRPC
patients. Data from the Phase 1 dose escalation phase of the trial
are expected in the second half of 2022 and data from the Phase 2a
expansion cohort are expected in the first half of 2023.
Early-Stage Pipeline
Development: In addition to LAVA’s two lead programs, the
Company is developing a portfolio of earlier stage
Gammabody™ programs including LAVA-1223, a
Gammabody™ directed at the epidermal growth factor receptor
(EGFR) for the treatment of solid tumors, for which a clinical
trial application (CTA) is planned for late 2022. There is
potential for targeting several EGFR-expressing tumors with
LAVA-1223, including: colorectal cancer, head and neck squamous
cell carcinoma, non-small cell lung cancer and pancreatic
cancer.
LAVA today announces the addition of LAVA-1266,
a CD123 Gammabody™, to its pipeline for the treatment of
hematological malignancies. A CTA is planned for late 2023. CD123
is overexpressed in a wide range of hematological malignancies,
including AML, B-cell acute lymphoblastic leukemia, hairy cell
leukemia, Hodgkin lymphoma, blastic plasmacytoid dendritic cell
neoplasm, B-cell chronic lymphoproliferative disorders and
myelodysplastic syndrome.
Fourth Quarter and Annual Financial
Results
- As of December
31, 2021, LAVA had cash, cash equivalents and investments totaling
$133.2 million compared to cash and cash equivalents of $15.8
million as of December 31, 2020. The increase was primarily
attributable to proceeds from the Series C financing and
subsequent IPO during the first quarter of 2021, partially offset
by operating expenses.
- Research and license revenue was
solely attributable to the company’s collaboration with Janssen
Biotech, Inc. which was entered into in May 2020.
- Research and development expenses
were $6.9 million and $37.2 million for the quarter and year ended
December 31, 2021, respectively, compared to $5.2 million and $15.7
million for the quarter and year ended December 31, 2020. The
increase for the quarter was primarily due to increases in clinical
trial, headcount and other costs incurred in connection with
advancing our lead Gammabody™ clinical candidates, LAVA-051
and LAVA-1207, into human clinical trials. The increase for the
year also includes $14.4 million in license fees triggered by the
IPO, most of which will be paid on the first and second
anniversaries of our IPO and may be paid in either cash or common
stock of the Company.
- General and
administrative expenses were $3.9 million and $12.2 million for the
quarter and year ended December 31, 2021, compared to general
administrative expenses of $0.4 million and $2.7 million for the
quarter and year ended December 31, 2020. The increases for the
quarter and year were primarily due to increases in
personnel-related costs, non-cash share-based compensation expense
and additional insurance, professional and consultant fees incurred
in connection with being a publicly traded company in the United
States.
- Net losses were
$9.9 million and $3.7 million, or $0.38 and $12.97 loss per share
for the quarters ended December 31, 2021 and 2020, respectively and
were $45.3 million and $15.5 million, or $2.30 and $38.85 loss per
share for the years ended December 31, 2021 and 2020,
respectively.
LAVA Therapeutics
N.V.Condensed Consolidated Statements of Loss
(unaudited)(in thousands, except share and per
share amounts)
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Research and license revenue |
$ |
1,000 |
|
|
$ |
2,000 |
|
|
$ |
5,000 |
|
|
$ |
3,500 |
|
Total revenue |
|
1,000 |
|
|
|
2,000 |
|
|
|
5,000 |
|
|
|
3,500 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
(6,882 |
) |
|
|
(5,190 |
) |
|
|
(37,193 |
) |
|
|
(15,701 |
) |
General and administrative |
|
(3,910 |
) |
|
|
(429 |
) |
|
|
(12,160 |
) |
|
|
(2,719 |
) |
Total operating
expenses |
|
(10,792 |
) |
|
|
(5,619 |
) |
|
|
(49,353 |
) |
|
|
(18,420 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(9,792 |
) |
|
|
(3,619 |
) |
|
|
(44,353 |
) |
|
|
(14,920 |
) |
Non-operating expenses |
|
(1 |
) |
|
|
7 |
|
|
|
(837 |
) |
|
|
(543 |
) |
Loss before income
tax |
|
(9,793 |
) |
|
|
(3,612 |
) |
|
|
(45,190 |
) |
|
|
(15,463 |
) |
Income tax expense |
|
(58 |
) |
|
|
(43 |
) |
|
|
(157 |
) |
|
|
(43 |
) |
Net loss |
$ |
(9,851 |
) |
|
$ |
(3,655 |
) |
|
$ |
(45,347 |
) |
|
$ |
(15,506 |
) |
Net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.38 |
) |
|
$ |
(12.97 |
) |
|
$ |
(2.30 |
) |
|
$ |
(38.85 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
25,775,538 |
|
|
|
281,775 |
|
|
|
19,758,169 |
|
|
|
399,126 |
|
LAVA Therapeutics
N.V.Condensed Consolidated Statements of Financial
Position (unaudited)(in thousands)
|
|
|
As of December 31, |
|
2021 |
|
2020 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Non-current assets |
$ |
2,742 |
|
|
$ |
2,264 |
|
Other current assets |
|
3,302 |
|
|
|
2,404 |
|
Cash, cash equivalents and
investments |
|
133,203 |
|
|
|
15,818 |
|
Total
assets |
$ |
139,247 |
|
|
$ |
20,486 |
|
|
|
|
|
|
|
|
|
Equity and
Liabilities: |
|
|
|
|
|
|
|
Total
Equity |
$ |
118,367 |
|
|
$ |
7,621 |
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
1,527 |
|
|
|
6,176 |
|
Lease liabilities |
|
581 |
|
|
|
478 |
|
License liabilities |
|
10,056 |
|
|
|
— |
|
Borrowings |
|
4,284 |
|
|
|
3,604 |
|
Trade payables and other |
|
2,553 |
|
|
|
934 |
|
Accrued expenses and other
current liabilities |
|
1,879 |
|
|
|
1,673 |
|
Total
liabilities |
|
20,880 |
|
|
|
12,865 |
|
Total equity and
liabilities |
$ |
139,247 |
|
|
$ |
20,486 |
|
|
|
|
|
|
|
|
About LAVA Therapeutics
LAVA Therapeutics N.V. is an
immuno-oncology company utilizing its proprietary Gammabody™
platform to develop a portfolio of bispecific gamma delta T
cell engagers for the potential treatment of solid tumors and
hematological malignancies. The Company’s innovative approach
utilizes bispecific antibodies engineered to selectively kill
cancer cells via the triggering of Vγ9Vδ2 (Vgamma9 Vdelta2) T cell
antitumor effector functions upon cross-linking to tumor associated
antigens. A Phase 1/2a clinical study evaluating LAVA-051 in
patients with certain hematological malignancies is currently
enrolling (NCT04887259). The Company currently anticipates
additional data from the Phase 1 dose escalation phase of the
LAVA-051 study in the second quarter of 2022 and data from the
Phase 2a expansion cohorts in the second half of 2022. A Phase 1/2a
clinical study to evaluate LAVA-1207 in patients with metastatic
castration-resistant prostate cancer (mCRPC) is enrolling with data
from the Phase 1 dose escalation phase of the trial expected in the
second half of 2022 and data from the Phase 2a expansion cohort in
the first half of 2023. For more information, please visit
www.lavatherapeutics.com and follow us on
LinkedIn, Twitter and YouTube.
LAVA’s Cautionary
Note on
Forward-Looking Statements
This press release contains forward-looking
statements, including in respect to the company’s anticipated
growth and clinical developments plans, including the timing of
clinical trials. Words such as “anticipate,” “believe,” “could,”
“will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,”
“potential” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are based on LAVA’s expectations and
assumptions as of the date of this press release and are subject to
various risks and uncertainties that may cause actual results to
differ materially from these forward-looking statements.
Forward-looking statements contained in this press release include,
but are not limited to, statements about the preclinical data,
clinical development and scope of clinical trials, and the
potential use of our product candidates to treat various tumor
targets. Many factors, risks and uncertainties may cause
differences between current expectations and actual results
including, among other things, the timing and results of our
research and development programs and preclinical and clinical
trials, our ability to obtain regulatory approval for and
commercialize our product candidates, our ability to leverage our
initial programs to develop additional product candidates using our
Gammabody™ platform, and the failure of LAVA’s collaborators
to support or advance collaborations or our product candidates. In
addition, the COVID-19 pandemic may disrupt our business and that
of the third parties on which we depend, including delaying or
otherwise disrupting our clinical trials and preclinical studies,
manufacturing and supply chain, or impairing employee productivity.
LAVA assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
CONTACTS |
|
Edward Smith |
Catherine Day |
Chief Financial Officer |
+1-917-763-2709 |
ir@lavatherapeutics.com |
catherine@newdaybioconsulting.com |
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