LAVA Therapeutics Provides Business Update and Reports Second Quarter Financial Results
September 13 2022 - 4:05PM
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 second quarter ended June
30, 2022.
“In the second quarter, we continued to enroll
patients in our two clinical programs, LAVA-051 and LAVA-1207,”
said Stephen Hurly, president and chief executive officer of LAVA
Therapeutics. “Notably, at ASCO and EHA, we presented encouraging
initial dose escalation data from the Phase 1/2a clinical trial of
LAVA-051. While still early, we are pleased with LAVA-051’s
attractive safety profile and signs of potential anti-tumor
activity and are excited about its potential as a therapy that can
overcome challenges with current T cell approaches.”
Recent Pipeline and Business
Highlights
LAVA-051Gammabody targeting
CD1d-expressing tumors, including multiple myeloma (MM), chronic
lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)
- Presented initial dose escalation data from the Phase 1/2a
clinical trial of LAVA-051 in patients with CLL and MM at the 2022
ASCO Annual Meeting, held June 3-7, 2022, and at the EHA 2022
Congress, held June 9-12, 2022. In addition to demonstrating a
favorable safety profile and signs of potential clinical anti-tumor
activity, LAVA-051 showed predictable and linear
pharmacokinetics and on-mechanism pharmacodynamic parameters
consistent with Vγ9Vδ2-T cell engagement, including increasing
occupancy of LAVA-051 on patient Vγ9Vδ2-T cells and consistent
increases in the expression of T cell activation
markers.
- Received clearance from the U.S. Food and Drug Administration
to enroll patients in the U.S. in the Phase 1/2a clinical trial for
the treatment of relapsed or refractory CLL, MM and AML.
- Hosted a clinical update call featuring Arnon Kater, M.D.,
Ph.D., chairman of the Dutch/Belgium HOVON CLL working group and
professor of translational hematology at the Amsterdam University
Medical Center, and LAVA-051 clinical trial investigator. The call
summarized initial Phase 1/2a clinical trial data presented at the
2022 ASCO and EHA meetings and can be accessed on demand at this
link.
- Additional clinical data are expected in the fourth quarter of
2022.
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)
- Enrollment continues in Europe and the U.S. 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.
- Initial Phase 1 data readout is expected in the fourth quarter
of 2022.
Early-Stage
Gammabody Pipeline
DevelopmentLAVA-1223, a Gammabody directed at the
epidermal growth factor receptor (EGFR) for the treatment of solid
tumors which induces tumor cell lysis independent of EGFR
downstream signaling mutations (e.g. KRAS/BRAF)
- A clinical trial application (CTA)
and/or IND is planned for late 2022.
Remarked Benjamin Winograd, M.D., Ph.D., chief
medical officer of LAVA Therapeutics, “We are optimistic about
LAVA-1223, a Gammabody directed at the epidermal growth factor
receptor (EGFR), our second program in solid tumors. EGFR is a
well-validated target in a broad range of malignancies. LAVA-1223
has demonstrated the potential to overcome certain limitations of
other anti-EGFR drugs, and specifically, our LAVA-1223 Gammabody
‘uses’ the EGFR receptor predominantly for homing purposes. As with
other Gammabodies, we have observed a tumor preferential effect
which may avoid some of the on-target, off tumor adverse effects
seen with other anti-EGFR drugs.”
LAVA-1266, a CD123 Gammabody for the treatment
of hematologic malignancies
- A CTA and/or IND is planned for
late 2023.
Second Quarter Financial
Results
The financial information provided below
reflects changes made to previously issued condensed consolidated
interim financial statements to revise immaterial prior period
misstatements. Further information regarding the revision is
included in our condensed consolidated interim financial
statements, "Note 11 — Revision of Immaterial Misstatements,"
included as Exhibit 99.1 to this current report on Form 6-K.
- As of June 30, 2022, LAVA had cash, cash equivalents, and
investments totaling $110.7 million compared to cash and cash
equivalents of $133.2 million as of December 31, 2021, which
we expect to be sufficient to fund the Company for approximately
two years.
- 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 $8.3 million and $15.9
million for the three and six months ended June 30, 2022,
respectively, compared to $4.9 million and $23.6 million for the
three and six months ended June 30, 2021. The increase for the
three months ended June 30, 2022 was primarily driven by increases
in clinical trial costs, headcount and other costs incurred in
connection with advancing our lead Gammabody clinical candidates,
LAVA-051 and LAVA-1207, into human clinical trials. For the six
months ended June 30, 2022, the decrease was driven by the $14.3
million VUmc license fees incurred in the first quarter of 2021,
partially offset by increases in clinical trial costs, 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 $3.0 million and $7.3
million for the three and six months ended June 30, 2022,
respectively, compared to $2.8 million and $4.5 million for the
three and six months ended June 30, 2021. The increase for both
periods was primarily due to costs associated with being a
publicly-traded company in the United States, including increases
in personnel-related costs and additional insurance, severance and
professional and consultant fees. For the three months that ended
June 30, 2022, the increases were partially offset by the reversal
of stock-based compensation expense for unvested forfeited stock
options.
- Net losses were $7.9 million and $17.8 million, or $0.31 and
$0.69 loss per share, for the three and six months ended June 30,
2022, respectively.
LAVA Therapeutics
N.V.Condensed Consolidated Interim Statements of
Lossand Comprehensive Loss(in
thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
|
June, 30 |
|
June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and license revenue |
|
|
$ |
468 |
|
|
$ |
1,080 |
|
|
$ |
1,490 |
|
|
$ |
2,189 |
|
|
Total
revenue |
|
|
|
468 |
|
|
|
1,080 |
|
|
|
1,490 |
|
|
|
2,189 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
(8,342 |
) |
|
|
(4,896 |
) |
|
|
(15,944 |
) |
|
|
(23,607 |
) |
|
General and administrative |
|
|
|
(3,016 |
) |
|
|
(2,764 |
) |
|
|
(7,314 |
) |
|
|
(4,491 |
) |
|
Total operating
expenses |
|
|
|
(11,358 |
) |
|
|
(7,659 |
) |
|
|
(23,258 |
) |
|
|
(28,098 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
|
|
(10,890 |
) |
|
|
(6,579 |
) |
|
|
(21,768 |
) |
|
|
(25,909 |
) |
|
Interest expense, net |
|
|
|
(90 |
) |
|
|
(187 |
) |
|
|
(253 |
) |
|
|
(316 |
) |
|
Foreign currency exchange gain
(loss), net |
|
|
|
3,136 |
|
|
|
(1,239 |
) |
|
|
4,248 |
|
|
|
(922 |
) |
|
Total non-operating
income (expenses) |
|
|
|
3,046 |
|
|
|
(1,426 |
) |
|
|
3,995 |
|
|
|
(1,238 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax |
|
|
|
(7,844 |
) |
|
|
(8,005 |
) |
|
|
(17,773 |
) |
|
|
(27,147 |
) |
|
Income tax expense |
|
|
|
(76 |
) |
|
|
(32 |
) |
|
|
(135 |
) |
|
|
(55 |
) |
|
Loss for the
year |
|
|
$ |
(7,920 |
) |
|
$ |
(8,037 |
) |
|
$ |
(17,908 |
) |
|
$ |
(27,202 |
) |
|
Foreign currency translation
adjustment |
|
|
|
(6,659 |
) |
|
|
1,648 |
|
|
|
(8,862 |
) |
|
|
569 |
|
|
Total comprehensive
loss |
|
|
$ |
(14,579 |
) |
|
$ |
(6,389 |
) |
|
$ |
(26,770 |
) |
|
$ |
(26,633 |
) |
|
Loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic and
diluted |
|
|
$ |
(0.31 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.99 |
) |
|
Weighted-average common shares
outstanding, basic and diluted |
|
|
|
25,780,811 |
|
|
|
25,523,501 |
|
|
|
25,778,190 |
|
|
|
13,641,062 |
|
|
LAVA Therapeutics
N.V.Condensed Consolidated Interim Statements of
Financial Position(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
Non-current assets |
|
$ |
2,515 |
|
$ |
2,742 |
Other current assets |
|
|
2,077 |
|
|
3,302 |
Cash, cash equivalents, and
investments |
|
|
110,714 |
|
|
133,203 |
Total
assets |
|
$ |
115,306 |
|
$ |
139,247 |
|
|
|
|
|
|
|
Equity and
Liabilities: |
|
|
|
|
|
|
Total
Equity |
|
$ |
94,038 |
|
$ |
118,367 |
|
|
|
|
|
|
|
Deferred revenue |
|
|
— |
|
|
1,527 |
Lease liabilities |
|
|
501 |
|
|
581 |
License liabilities |
|
|
9,251 |
|
|
10,056 |
Borrowings |
|
|
4,329 |
|
|
4,284 |
Trade payables and other |
|
|
2,930 |
|
|
2,553 |
Accrued expenses and other
current liabilities |
|
|
4,257 |
|
|
1,879 |
Total
liabilities |
|
|
21,268 |
|
|
20,880 |
|
|
|
|
|
|
|
Total equity and
liabilities |
|
$ |
115,306 |
|
$ |
139,247 |
|
|
|
|
|
|
|
About LAVA Therapeutics
LAVA 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 hematologic 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 the timing and
results 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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