UTRECHT, The Netherlands and PHILADELPHIA, Nov. 16, 2022 (GLOBE NEWSWIRE) -- 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, today announced recent corporate highlights and financial results for the third quarter ended September 30, 2022.
“The third quarter was productive for LAVA, underscored by the recent and upcoming presentations of additional interim clinical data from the Phase 1/2a trial of our lead clinical program, LAVA-051, at SITC and ASH, respectively,” said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. “We were also pleased to announce our worldwide license agreement with Seagen for the development of LAVA-1223, our advanced preclinical asset targeting EGFR-expressing solid tumors. This partnership represents a major step toward our goal of creating effective Gammabody medicines for patients with cancer and enables LAVA to progress additional candidates from our early-stage pipeline of bispecific gamma delta T cell engagers.”
Recent Pipeline and Business Highlights
LAVA-051
Gammabody targeting CD1d-expressing tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)
LAVA-1207
Gammabody targeting 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)
Early-Stage Gammabody Pipeline Development
LAVA-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)
Business Update
Third Quarter Financial Results
LAVA Therapeutics N.V.
Condensed Consolidated Interim Statements of Profit and Loss
and Comprehensive Profit and Loss
(in thousands, except share and per share amounts) (unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||||
September 30, | September 30, | |||||||||||||||||
Notes | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
Revenue: | ||||||||||||||||||
Research and license revenue | 6 | $ | 15,261 | $ | 2,095 | $ | 16,751 | $ | 4,284 | |||||||||
Total revenue | 15,261 | 2,095 | 16,751 | 4,284 | ||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | 7 | (13,675 | ) | (6,703 | ) | (29,619 | ) | (30,311 | ) | |||||||||
General and administrative | 8 | (3,096 | ) | (3,760 | ) | (10,410 | ) | (8,250 | ) | |||||||||
Total operating expenses | (16,771 | ) | (10,463 | ) | (40,029 | ) | (38,561 | ) | ||||||||||
Operating profit (loss) | (1,510 | ) | (8,368 | ) | (23,278 | ) | (34,277 | ) | ||||||||||
Interest income (expense), net | 39 | (158 | ) | (214 | ) | (474 | ) | |||||||||||
Foreign currency exchange gain, net | 2,515 | 1,637 | 6,763 | 715 | ||||||||||||||
Total non-operating income | 2,554 | 1,479 | 6,549 | 241 | ||||||||||||||
Profit (loss) before income tax | 1,044 | (6,889 | ) | (16,729 | ) | (34,036 | ) | |||||||||||
Income tax expense | (47 | ) | (44 | ) | (182 | ) | (100 | ) | ||||||||||
Profit (loss) for the year | $ | 997 | $ | (6,933 | ) | $ | (16,911 | ) | $ | (34,136 | ) | |||||||
Foreign currency translation adjustment | (5,359 | ) | (3,317 | ) | (14,220 | ) | (2,748 | ) | ||||||||||
Total comprehensive profit (loss) | $ | (4,362 | ) | $ | (10,250 | ) | $ | (31,131 | ) | $ | (36,884 | ) | ||||||
Profit (Loss) per share: | ||||||||||||||||||
Profit (loss) per share, basic | $ | 0.04 | $ | (0.27 | ) | $ | (0.66 | ) | $ | (1.93 | ) | |||||||
Weighted-average common shares outstanding, basic | 25,845,802 | 25,775,538 | 25,800,973 | 17,730,337 | ||||||||||||||
Profit (loss) per share, diluted | $ | 0.04 | (0.27 | ) | (0.66 | ) | (1.93 | ) | ||||||||||
Weighted-average common shares outstanding, diluted | 26,446,259 | 25,775,538 | 25,800,973 | 17,730,337 | ||||||||||||||
LAVA Therapeutics N.V.
Condensed Consolidated Interim Statements of Financial Position
(in thousands) (unaudited)
September 30, | December 31, | |||||||||||
2022 | 2021 | |||||||||||
Assets: | ||||||||||||
Non-current assets | $ | 2,289 | $ | 2,742 | ||||||||
Other current assets | 54,876 | 3,302 | ||||||||||
Cash, cash equivalents, and investments | 92,724 | 133,203 | ||||||||||
Total assets | $ | 149,889 | $ | 139,247 | ||||||||
Equity and Liabilities: | ||||||||||||
Total Equity | $ | 92,658 | $ | 118,367 | ||||||||
Deferred revenue | 35,000 | 1,527 | ||||||||||
Lease liabilities | 459 | 581 | ||||||||||
License liabilities | 4,355 | 10,056 | ||||||||||
Borrowings | 4,173 | 4,284 | ||||||||||
Trade payables and other | 7,799 | 2,553 | ||||||||||
Accrued expenses and other current liabilities | 5,445 | 1,879 | ||||||||||
Total liabilities | 57,231 | 20,880 | ||||||||||
Total equity and liabilities | $ | 149,889 | $ | 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 Statements
This press release contains forward-looking statements, including with respect to the Company’s anticipated growth and clinical development plans including 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.
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Market Cap: | US$44.130M |
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