LAVA Therapeutics Provides Business Update and Reports Third Quarter Financial Results
15 November 2021 - 11:00PM
LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage
biotechnology company focused on developing its proprietary
Gammabody™ platform of bispecific gamma delta T cell engagers
(bsTCEs) to transform the treatment of cancer, today announced
financial results for the third quarter ended Sept. 30, 2021 and
recent corporate highlights.
“This was a transformational quarter for LAVA,”
said Stephen Hurly, president and chief executive officer. “With
our lead GammabodyTM program in the clinic and actively enrolling
patients in hematological malignancies and our second program on
track to enroll its first prostate cancer patient later this
quarter, LAVA is poised for potential product and platform
validating data milestones in 2022. Our progress in the clinic,
along with our recent senior leadership hires and strong balance
sheet, position us well to execute on our mission to unlock the
value of our GammabodyTM platform to deliver transformative
treatments to those suffering from cancer.”
Recent Business and Pipeline
Highlights
LAVA-051 Phase 1/2a Trial on
Track: Enrollment is ongoing in the Phase 1/2a
clinical trial (NCT04887259) evaluating LAVA-051 in hematological
malignancies. The trial is designed to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
and preliminary antitumor activity of LAVA-051. Data from the Phase
1 dose escalation phase of the trial are expected in the first half
of 2022 and top line data from the Phase 2a expansion cohorts in
the second half of 2022. The trial was initiated in July 2021 in
patients with relapsed or refractory chronic lymphocytic leukemia
(CLL) and multiple myeloma (MM) and will, later in the trial, also
include patients with acute myeloid leukemia (AML).
LAVA-051 Granted U.S. FDA Orphan Drug
Designation: On October 15, the company announced
that the U.S. Food and Drug Administration (FDA) granted orphan
drug designation to LAVA-051 for the treatment of CLL, a rare form
of leukemia characterized by progressive accumulation of abnormal
lymphocytes in the peripheral blood, bone marrow and lymphoid
tissues. This orphan drug designation from the FDA qualifies LAVA
for various incentives related to the development of LAVA-051,
including tax credits for qualified clinical trials, exemption from
user fees and the potential for seven years of U.S. market
exclusivity for the treatment of CLL.
LAVA-1207 Phase 1/2a Trial Plans on
Track: LAVA is on track to initiate the company’s
Phase 1/2a clinical trial of LAVA-1207 in patients with metastatic
castration-resistant prostate cancer (mCRPC) later in the fourth
quarter. LAVA-1207 is a Gammabody™ that targets the prostate
specific membrane antigen (PSMA) and has demonstrated preclinical
proof-of-concept in a variety of preclinical models to support
acceptance of a CTA/IND to study in humans. The open-label,
multi-center, Phase 1/2a clinical trial will evaluate safety,
tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
and preliminary antitumor activity of LAVA-1207 in patients with
mCRPC. The Phase 1 dose-escalation portion 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.
Strategic Management Team Expansion with
Three Key Appointments: On November 9, the company
announced three strategic appointments to the management team.
- Jessica Truscello, vice president
of clinical operations, brings more than 22 years of clinical trial
and clinical operations experience to LAVA and most recently served
six years at Immunocore where she supported first-in-human programs
through pivotal and late-stage programs and the
successful development of their clinical compliance
program.
- Sumeet Ambarkhane, M.D., executive
medical director, a clinical development physician with more than
17 years of experience with expertise in oncology, hemato-oncology
and immunology. Dr. Ambarkhane was previously at MorphoSys, where
he led medical and clinical strategy for its hemato-oncology
clinical development program.
- Wouter van Hunnik, vice president
of human resources, joins the company from Philips with more than
15 years of experience in building excellence and taking innovative
approaches to human resources (HR) recruitment, culture shaping and
capability building.
Third Quarter Financial Results
- Cash, cash
equivalents and investments were €122.7 million as
of Sept. 30, 2021, compared to €12.9 million as of
Dec. 31, 2020. The increase in cash and cash equivalents was
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 increased to €1.8 million and €3.6 million for the
three and nine months ended Sept. 30, 2021, respectively,
compared to €0.8 million and €1.4 million for the three and
nine months ended Sept. 30, 2020. Research and license
revenue is solely attributable to the company’s collaboration with
Janssen Biotech, Inc., which was entered into in
May 2020. During the three months ended Sept. 30,
2021, the company earned a €0.9 million research milestone under
the agreement.
- Research and
development expenses were €5.7 million and €25.5 million for the
three and nine months ended Sept. 30, 2021, respectively,
compared to €3.3 million and €9.3 million for the three and
nine months ended Sept. 30, 2020. The increase for the
three months ended Sept. 30, 2021, was primarily due to
increases in headcount and costs associated with the commencement
of our LAVA-051 clinical trial. The increase for the
nine months ended Sept. 30, 2021 was additionally due to
license fees of €12.0 million triggered by the IPO, most of which
will be paid on the first and second anniversaries of the IPO and
may be paid in either cash or common stock of the Company.
- General and
administrative expenses were €3.2 million and €7.0 million for the
three and nine months ended Sept. 30, 2021, respectively,
compared to general administrative expenses of €0.7 million and
€2.0 million for the three and nine months ended
Sept. 30, 2020. The increase in both periods is primarily due
to the increase in personnel-related costs, non-cash share-based
compensation expense and additional costs associated with being a
publicly traded company in the United States.
- Net loss was
€7.5 million and €29.8 million, or €0.23 and €1.62 loss per share
for the three and nine months ended Sept. 30, 2021,
respectively, compared to €3.4 million and €10.5 million, or €8.43
and €24.38 loss per share, for the three and nine months ended
Sept. 30, 2020.
About LAVA TherapeuticsLAVA
Therapeutics N.V. is a clinical-stage biotechnology company
utilizing its proprietary Gammabody™ platform to develop a
portfolio of bispecific gamma delta T cell engagers (gamma delta
bsTCEs) 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 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 data from the Phase 1 dose
escalation phase of the study in the first half of 2022 with top
line clinical data from the Phase 2a expansion cohorts expected in
the second half of 2022. The company plans to initiate a Phase 1/2a
clinical study to evaluate LAVA-1207 in patients with prostate
cancer in the fourth quarter of 2021. For more information, please
visit www.lavatherapeutics.com and follow us on LinkedIn and
Twitter.
LAVA’s Cautionary Note on
Forward-Looking StatementsThis press release contains
forward-looking statements, including in respect of 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
GammabodyTM 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.
LAVA Therapeutics
N.V.Unaudited Condensed Consolidated Interim
Statements of Loss and Comprehensive LossEUR
(000’s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and license revenue |
|
|
€ |
1,781 |
|
|
€ |
827 |
|
|
€ |
3,599 |
|
|
€ |
1,419 |
|
Total revenue |
|
|
|
1,781 |
|
|
|
827 |
|
|
|
3,599 |
|
|
|
1,419 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
(5,714 |
) |
|
|
(3,292 |
) |
|
|
(25,476 |
) |
|
|
(9,302 |
) |
General and administrative |
|
|
|
(3,213 |
) |
|
|
(660 |
) |
|
|
(6,969 |
) |
|
|
(2,013 |
) |
Total operating
expenses |
|
|
|
(8,927 |
) |
|
|
(3,952 |
) |
|
|
(32,445 |
) |
|
|
(11,315 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
|
|
(7,146 |
) |
|
|
(3,125 |
) |
|
|
(28,846 |
) |
|
|
(9,896 |
) |
Total non-operating
expenses |
|
|
|
(278 |
) |
|
|
(235 |
) |
|
|
(890 |
) |
|
|
(611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax |
|
|
|
(7,424 |
) |
|
|
(3,360 |
) |
|
|
(29,736 |
) |
|
|
(10,507 |
) |
Income tax expense |
|
|
|
(38 |
) |
|
|
— |
|
|
|
(85 |
) |
|
|
— |
|
Net loss |
|
|
€ |
(7,462 |
) |
|
€ |
(3,360 |
) |
|
€ |
(29,821 |
) |
|
€ |
(10,507 |
) |
Foreign currency translation
adjustment |
|
|
|
1,582 |
|
|
|
(184 |
) |
|
|
1,178 |
|
|
|
(184 |
) |
Total comprehensive
loss |
|
|
€ |
(5,880 |
) |
|
€ |
(3,544 |
) |
|
€ |
(28,643 |
) |
|
€ |
(10,691 |
) |
Net loss per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
|
€ |
(0.23 |
) |
|
€ |
(8.43 |
) |
|
€ |
(1.62 |
) |
|
€ |
(24.38 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
|
25,775,538 |
|
|
|
420,563 |
|
|
|
17,730,337 |
|
|
|
438,464 |
|
LAVA Therapeutics
N.V.Condensed Consolidated Interim Statements of
Financial PositionEUR (000’s)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
(unaudited) |
|
(1) |
Assets |
|
|
|
|
|
|
Non-current assets |
|
€ |
2,274 |
|
€ |
1,843 |
|
Other current assets |
|
|
5,258 |
|
|
1,959 |
|
Cash, cash equivalents and
investments |
|
|
122,683 |
|
|
12,881 |
|
Total
assets |
|
€ |
130,215 |
|
€ |
16,683 |
|
|
|
|
|
|
|
|
Equity and
Liabilities |
|
|
|
|
|
|
Total
Equity |
|
€ |
110,781 |
|
€ |
6,207 |
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
2,280 |
|
|
5,030 |
|
Lease liabilities |
|
|
569 |
|
|
389 |
|
License liabilities |
|
|
8,873 |
|
|
— |
|
Borrowings |
|
|
3,519 |
|
|
2,935 |
|
Trade payables and other |
|
|
1,646 |
|
|
760 |
|
Accrued expenses and other
current liabilities |
|
|
2,547 |
|
|
1,362 |
|
Total
liabilities |
|
|
19,434 |
|
|
10,476 |
|
|
|
|
|
|
|
|
Total equity and
liabilities |
|
€ |
130,215 |
|
€ |
16,683 |
|
(1) Derived
from the audited consolidated financial statements of LAVA
Therapeutics N.V. for the year ended December 31, 2020, included on
the Form F-1 filed with the Securities and Exchange Commission on
March 29, 2021.CONTACTSEdward SmithChief Financial
Officerir@lavatherapeutics.com Catherine
Day+1-917-763-2709catherine@newdaybioconsulting.com
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