Enrollment continues in Phase 1/2a trial evaluating LAVA-051 in hematological malignancies
CTA accepted and IND cleared for Phase 1/2a trial evaluating LAVA-1207 in metastatic castrate resistant prostate cancer; on track to begin later this year
Collaboration with
Cash balance of
“We continue our strong execution, meeting key milestones and progressing our two lead, first-in-class bispecific gamma-delta T cell engager clinical programs,” said Stephen Hurly, chief executive officer of
Recent Business and Pipeline Highlights
Dosing of the First Patient in Phase 1/2a Trial of LAVA-051: In July, LAVA announced it had initiated dosing in the Company’s Phase 1/2a clinical trial evaluating LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). LAVA-051 is a humanized bsTCE engineered to selectively target CD1d-expressing hematological cancers through activation of both gamma-delta T cells and type 1 natural killer T (NKT) cells. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of LAVA-051. Initially conducted in
Acceptance of CTA and IND for LAVA-1207: The Company’s CTA was accepted and the IND was cleared to initiate a Phase 1/2a clinical study to assess tolerability and efficacy of LAVA-1207 in patients with metastatic castration-resistant prostate cancer. LAVA-1207 is a gamma-delta bsTCE targeting the prostate-specific membrane antigen (PSMA) that demonstrated preclinical proof-of-concept. The Company anticipates that patient enrollment will begin in
Research and License Agreement with Janssen. Under the terms of the agreement, the Company is performing discovery and product development activities with novel bispecific antibodies to gamma-delta T cells for the treatment of cancer. The collaboration is on track and, in addition to an upfront payment, the Company is eligible to receive potential development and commercial milestones and future tiered royalties based on the development of the collaboration.
Executive Leadership Team Strengthened by Appointment of
Second Quarter Financial Results
- Cash and cash equivalents were €128.4 million as of June 30, 2021, compared to €12.9 million as of
December 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 €0.9 million and €1.8 million for the three and six months ended
June 30, 2021 , respectively, compared to €0.6 million for the three and six months endedJune 30, 2020 . Research and license revenue is solely attributable to the company’s collaboration withJanssen Biotech, Inc. , which was entered into inMay 2020 . - Research and development expenses were €4.5 million and €20.2 million for the three and six months ended
June 30, 2021 , respectively, compared to €3.1 million and €6.0 million for the three and six months endedJune 30, 2020 . The increase for the three months endedJune 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 six months endedJune 30, 2021 was additionally due to license fees of €12.1 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 €1.9 million and €3.3 million for the three and six months ended
June 30, 2021 , respectively, compared to general administrative expenses of €0.7 million and €1.4 million for the three and six months endedJune 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 €5.8 million and €22.4 million, or €0.23 and €1.64 loss per share, for of the three and six months ended
June 30, 2021 , respectively, compared to €3.5 million and €7.1 million, or €7.75 and €15.97 loss per share, for the three and six months endedJune 30, 2020 .
About LAVA
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,” “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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA’s product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. 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.
Condensed Consolidated Interim Statements of Loss
EUR (000’s) (unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||
Research and license revenue | € | 897 | € | 592 | € | 1,818 | € | 592 | |||||||||
Operating expenses: | |||||||||||||||||
Research and development | (4,506 | ) | (3,074 | ) | (20,245 | ) | (6,010 | ) | |||||||||
General and administrative | (1,858 | ) | (672 | ) | (3,273 | ) | (1,353 | ) | |||||||||
Total operating expenses | (6,364 | ) | (3,746 | ) | (23,518 | ) | (7,363 | ) | |||||||||
Operating loss | (5,467 | ) | (3,154 | ) | (21,700 | ) | (6,771 | ) | |||||||||
Total non-operating expenses | (292 | ) | (318 | ) | (6,110 | ) | (376 | ) | |||||||||
Loss before income tax | (5,759 | ) | (3,472 | ) | (22,311 | ) | (7,147 | ) | |||||||||
Income tax (expense) benefit | (25 | ) | 3 | (47 | ) | — | |||||||||||
Net loss | € | (5,784 | ) | € | (3,469 | ) | € | (22,358 | ) | € | (7,147 | ) | |||||
Net loss per share, in Euros | |||||||||||||||||
Net loss per share, basic and diluted | € | (0.23 | ) | € | (7.75 | ) | € | (1.64 | ) | € | (15.97 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 25,523,501 | 447,525 | 13,641,062 | 447,525 |
Condensed Consolidated Interim Statements of Financial Position
EUR (000’s)
2021 | 2020 | ||||||||
(unaudited) | |||||||||
Assets | |||||||||
Non-current assets | € | 1,786 | € | 1,843 | |||||
Other current assets | 4,788 | 1,959 | |||||||
Cash and cash equivalents | 128,354 | 12,881 | |||||||
Total assets | € | 134,928 | € | 16,683 | |||||
Equity and Liabilities | |||||||||
Total Equity | € | 115,586 | € | 6,207 | |||||
Deferred revenue | 3,212 | 5,030 | |||||||
Lease liabilities | 366 | 389 | |||||||
License liabilities | 9,074 | — | |||||||
Borrowings | 3,262 | 2,935 | |||||||
Trade payables and other | 1,820 | 760 | |||||||
Accrued expenses and other current liabilities | 1,608 | 1,362 | |||||||
Total liabilities | 19,342 | 10,476 | |||||||
Total equity and liabilities | € | 134,928 | € | 16,683 |
Investor Contact:
cdavis@lifesciadvisors.com
212-915-2577
Source:
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