LAVA Therapeutics Provides Business Update and Reports First Quarter Financial Results
17 May 2022 - 9:00PM
LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical stage
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 first quarter ended March
31, 2022.
“We are pleased with the clinical development progress of our
lead product candidates. We continue to enroll patients in our
LAVA-051 trial focused on hematologic malignancies, and we look
forward to presenting updated interim data from the dose escalation
phase of this trial at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting in June,” said Stephen Hurly,
president and chief executive officer of LAVA Therapeutics. “We are
also excited about the continued progress of our lead solid tumor
program, LAVA-1207, as we recently dosed the first metastatic
castration-resistant prostate cancer patients in our Phase 1/2a
clinical trial. We will continue to enroll patients in this dose
escalation trial and announce initial data later this year.”
Recent Pipeline and Business Highlights
LAVA-051Gammabody that targets CD1d-expressing
tumors, including multiple myeloma, chronic lymphocytic leukemia
and acute myeloid leukemia (AML)
- Announced the presentation of data at the 2022 ASCO Annual
Meeting, being held June 3-7 in Chicago and virtually. Benjamin
Winograd, M.D., Ph.D., chief medical officer of LAVA Therapeutics,
will present abstract # 2577, “Phase I dose escalation of LAVA-051,
a novel bispecific gamma delta T-cell engager (Gammabody™), in
relapsed/refractory hematological malignancies,” and a short video
in the session, “Developmental Therapeutics — Immunotherapy,” on
Sunday, June 5, 2022, at 8–11 a.m. CDT/9 a.m.–12 p.m. EDT. The
Company will also present at the European Hematology Association
(EHA) 2022 Congress, being held in Vienna, Austria and
virtually.
- Presented initial data from the Company’s first clinical study
with LAVA-051 at the European Society for Medical Oncology Targeted
Anticancer Therapies (ESMO-TAT) Congress 2022 demonstrating that
the first three dose-escalation cohorts showed LAVA-051 to be safe
and well tolerated with no dose limiting toxicities or cytokine
release syndrome observed. The Company also presented preclinical
data illustrating the potential of its
Gammabody platform.
- Received clearance from the U.S. Food and Drug Administration
(FDA) to enroll patients in the U.S in the Phase 1/2a clinical
trial.
- Additional clinical data are expected in the second half of
2022, and initial Phase 2a expansion cohort data are expected in
the first half of 2023.
LAVA-1207Gammabody that targets the
prostate-specific membrane antigen (PSMA) to trigger the potent and
preferential killing of PSMA-positive tumor cells, including
metastatic castration-resistant prostate cancer (mCRPC)
- Dosed the first patient and continues enrollment in the
open-label, multi-center Phase 1/2a clinical trial evaluating the
tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
and preliminary antitumor activity of LAVA-1207 in patients with
mCRPC. The Phase 1 dose-escalation portion will determine the
optimal Phase 2 dose to be used in the subsequent Phase 2a
expansion cohort. The Phase 1/2a clinical trial for LAVA-1207 was
initiated in Europe.
- Presented preclinical data showing LAVA-1207 can
activate Vγ9Vδ2 (Vgamma9 Vdelta2) T cells to exert
cytotoxicity toward PSMA-expressing tumor cells at picomolar
concentrations, demonstrating potent and precise killing of
PSMA-expressing tumor cells, including those obtained from
patients.
- A Phase 1 data readout is expected in the second half of 2022,
and initial Phase 2a expansion cohort data are expected in the
first half of 2023.
Early-Stage Gammabody
Pipeline Development
LAVA-1223, a Gammabody directed at the epidermal growth
factor receptor (EGFR) for the treatment of solid tumors
- A clinical trial application (CTA) and/or IND is planned for
late 2022.
LAVA-1266, a CD123 Gammabody for the treatment of hematologic
malignancies
- Announced the addition of this drug candidate to LAVA’s
early-stage development program. CD123 is overexpressed in a wide
range of hematologic 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.
- A CTA and/or IND is planned for late 2023.
Business Update
- Ed Smith, chief financial officer of LAVA Therapeutics, has
resigned to pursue other interests, effective as of May 17,
2022. He may serve in a consulting capacity to support the
Company's transition. The Company has commenced a search for Mr.
Smith's permanent replacement.
First Quarter Financial Results
- As of March 31, 2022, LAVA had cash, cash equivalents and
investments totaling $124.2 million compared to cash and cash
equivalents of $133.2 million as of December 31, 2021.
- 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 $7.6 million for the
quarter ended March 31, 2022, compared to $18.7 million for the
quarter ended March 31, 2021. The decrease was primarily due to the
VUmc license fees incurred in 2021 at the time of our IPO of $14.3,
offset by 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.
- General and administrative expenses were $4.3 million for the
quarter ended March 31, 2022, compared to $1.7 million for the
quarter ended March 31, 2021. The increase for the quarter was
primarily due to increases in non-cash share-based compensation
expense of $0.9 million and other personnel-related costs as well
as costs associated with being a publicly-traded company in the
United States, including additional insurance costs, professional
fees and consulting fees.
- Net losses were $10.6 and $19.7 million, or $0.41 and $12.14
loss per share for the quarters ended March 31, 2022 and 2021,
respectively.
|
LAVA Therapeutics N.V. |
Condensed Consolidated Statements of Loss
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
Revenue: |
|
|
|
|
|
|
Research and license revenue |
|
$ |
1,000 |
|
|
$ |
1,000 |
|
Total
revenue |
|
|
1,000 |
|
|
|
1,000 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
(7,601 |
) |
|
|
(18,712 |
) |
General and administrative |
|
|
(4,298 |
) |
|
|
(1,727 |
) |
Total operating
expenses |
|
|
(11,899 |
) |
|
|
(20,439 |
) |
|
|
|
|
|
|
|
Operating
loss |
|
|
(10,899 |
) |
|
|
(19,439 |
) |
Total non-operating
expenses |
|
|
403 |
|
|
|
(279 |
) |
Loss before income
tax |
|
|
(10,496 |
) |
|
|
(19,718 |
) |
Income tax expense |
|
|
(59 |
) |
|
|
(24 |
) |
Loss for the
year |
|
$ |
(10,555 |
) |
|
$ |
(19,742 |
) |
Foreign currency translation
adjustment |
|
|
(2,216 |
) |
|
|
(1,076 |
) |
Total comprehensive
loss |
|
$ |
(12,771 |
) |
|
$ |
(20,818 |
) |
Loss per
share: |
|
|
|
|
|
|
Loss per share, basic and
diluted |
|
$ |
(0.41 |
) |
|
$ |
(12.14 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
25,775,538 |
|
|
|
1,626,598 |
|
Condensed Consolidated Statements of Financial Position
(unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Non-current assets |
|
$ |
2,818 |
|
|
$ |
2,742 |
Other current assets |
|
|
2,534 |
|
|
|
3,302 |
Cash, cash equivalents and
investments |
|
|
124,156 |
|
|
|
133,203 |
Total
assets |
|
$ |
129,508 |
|
|
$ |
139,247 |
|
|
|
|
|
|
|
Equity and
Liabilities: |
|
|
|
|
|
|
Total
Equity |
|
$ |
108,409 |
|
|
$ |
118,367 |
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
485 |
|
|
|
1,527 |
Lease liabilities |
|
|
587 |
|
|
|
581 |
License liabilities |
|
|
9,870 |
|
|
|
10,056 |
Borrowings |
|
|
4,509 |
|
|
|
4,284 |
Trade payables and other |
|
|
2,656 |
|
|
|
2,553 |
Accrued expenses and other
current liabilities |
|
|
2,992 |
|
|
|
1,879 |
Total
liabilities |
|
|
21,099 |
|
|
|
21,880 |
|
|
|
|
|
|
|
|
Total equity and
liabilities |
|
$ |
129,508 |
|
|
$ |
139,247 |
|
|
|
|
|
|
|
|
About LAVA TherapeuticsLAVA Therapeutics N.V.
is a clinical stage 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 and hematological malignancies. The Company utilizes
bispecific antibodies engineered to selectively kill cancer cells
by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector
functions upon cross-linking to tumor-associated antigens.
LAVA-051, the Company’s lead candidate for the treatment of
multiple myeloma, chronic lymphocytic leukemia and acute myeloid
leukemia, is enrolling patients in a Phase 1/2a clinical study
(NCT04887259). A Phase 1/2a clinical study to evaluate LAVA-1207 in
patients with metastatic castration-resistant prostate cancer
(mCRPC) is also enrolling (NCT05369000). For more information,
please visit www.lavatherapeutics.com, and follow us on LinkedIn,
Twitter and YouTube.
LAVA’s Cautionary
Note on
Forward-Looking StatementsThis
press release contains forward-looking statements, including with
respect to the company’s anticipated growth and clinical
development 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. 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.
In addition, there may be adverse effects on our business condition
and results from general economic and market conditions and overall
fluctuations in the United States and international equity markets,
including deteriorating market conditions due to investor concerns
regarding inflation and hostilities between Russia and Ukraine.
LAVA assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
CONTACTSInvestor
Relationsir@lavatherapeutics.com
Argot Partners (IR/Media)212-600-1902lava@argotpartners.com
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