- LAVA-051 Phase 1/2a trial actively enrolling in hematological malignancies on track to report initial data in H1 2022
- LAVA-1207 Phase 1/2a trial in metastatic castrate resistant prostate cancer on track to begin enrolling later this quarter
- LAVA-051 granted orphan drug designation by the
U.S. FDA for the treatment of CLL - Cash and investments of
$142 million as ofSept. 30, 2021
“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
LAVA-051 Granted
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
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 atImmunocore 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 endedSept. 30, 2020 . Research and license revenue is solely attributable to the company’s collaboration with Janssen Biotech, Inc., which was entered into inMay 2020 . During the three months endedSept. 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 endedSept. 30, 2020 . The increase for the three months endedSept. 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 endedSept. 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 endedSept. 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 inthe 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 endedSept. 30, 2020 .
About
LAVA’s Cautionary Note on Forward-Looking Statements
This 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.
Unaudited Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
EUR (000’s)
Three Months Ended | Nine Months Ended | ||||||||||||||||
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 |
Condensed Consolidated Interim Statements of Financial Position
EUR (000’s)
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
CONTACTS
Chief Financial Officer
ir@lavatherapeutics.com
+1-917-763-2709
catherine@newdaybioconsulting.com
Source:
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