adjustment 2,155 7,471 2,073 (6,749)
---------- ---------- ---------- ----------
Total comprehensive
loss $ (4,343) $ (7,444) $ (39,901) $ (38,656)
========== ========== ========== ==========
Loss per share:
Loss per share,
basic and diluted $ (0.24) $ (0.57) $ (1.57) $ (1.23)
Weighted-average
common shares
outstanding, basic
and diluted 26,769,937 26,289,087 26,732,556 25,924,005
LAVA Therapeutics N.V.
Consolidated Statements of Financial Position
(in thousands) (unaudited)
As of December 31,
2023 2022
--------- ---------
Assets
Non-current assets:
Property and equipment, net $ 1,602 $ 1,432
Right-of-use assets 892 651
Other non-current assets and security
deposits 319 809
-------- --------
Total non-current assets 2,813 2,892
Current assets:
Receivables and other 1,459 3,254
Prepaid expenses and other current
assets 1,627 4,411
VAT receivable 240 --
Investments 51,340 32,535
Cash and cash equivalents 44,231 100,333
-------- --------
Total current assets 98,897 140,533
-------- --------
Total assets $ 101,710 $ 143,425
======== ========
Equity and Liabilities
Equity:
Share capital $ 3,715 $ 3,715
Equity-settled employee benefits
reserve 12,005 8,942
Foreign currency translation reserve (10,899) (12,972)
Additional paid-in capital 194,424 194,424
Accumulated deficit (148,067) (108,069)
-------- --------
Total equity 51,178 86,040
Non-current liabilities:
Deferred revenue 35,000 35,000
Lease liabilities 591 431
-------- --------
Total non-current liabilities 35,591 35,431
Current liabilities:
Trade payables and other 4,446 3,965
VAT payable -- 45
Borrowings 5,282 4,640
Lease liabilities 440 379
License liabilities -- 4,732
Accrued expenses and other current
liabilities 4,773 8,193
-------- --------
Total current liabilities 14,941 21,954
-------- --------
Total liabilities 50,532 57,385
-------- --------
Total equity and liabilities $ 101,710 $ 143,425
======== ========
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody$(R)$ platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering V<GAMMA>9V 2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens.
A Phase 1/2a dose escalation study (NCT05369000) to evaluate the lead program, LAVA-1207, in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States in a study evaluating monotherapy and combination treatment with interleukin-2 (IL-2). The Company is also planning to expand the Phase 1/2a study to include a combination arm with KEYTRUDA(R)(pembrolizumab), through a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA. The Company licensed PF-08046052 (formerly SGN-EGFRd2/LAVA-1223) to Pfizer Inc. for clinical development and commercialization. The pipeline also includes several pre-clinical programs. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, and YouTube.
KEYTRUDA(R) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA
Gammabody(R) is a registered trademark of LAVA Therapeutics N.V.
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," "suggests" 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 relating to the therapeutic potential, development and potential uses of LAVA's product candidates, the timing of initiation of clinical trials, including the expansion phase of the Phase 1/2a trial to evaluate LAVA-1207 in combination with KEYTRUDA(R), the potential of premedication and step-dosing to minimize the risk of CRS in our Phase 1/2a clinical trial for LAVA-1207, use of biomarkers and assays for patient selection, the relationship between <GAMMA> 2 T cells and antitumor activity, the timing of regulatory submissions, availability of information regarding clinical development plans, progress and data from clinical trials, the potential uses of LAVA's product candidates to treat various tumor targets, including AML, MDS, mCRPC, CRC, NSCLC, and HNSCC, and improve patient outcomes, LAVA's cash runway and the sufficiency of resources to pursue development activities. Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the Company's ability to leverage its initial programs to develop additional product candidates using our Gammabody(R) platform, and the failure of LAVA's collaborators to support or advance collaborations or LAVA's product candidates, the timing and results of LAVA's research and development programs and preclinical and clinical trials, the possibility that clinical trials may fail to establish sufficient efficacy, the risk that adverse events or safety signals may occur, in clinical trials, the risk that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials, the risk that adverse regulatory actions or other setbacks could occur in clinical trials even after promising results in earlier clinical trials or preclinical studies, the Company's ability to obtain regulatory approval for an commercialize its product candidates, the risk that setbacks in development could occur in clinical trials even after promising results in earlier trials or preclinical studies, and the risk that setbacks in development could occur as a result of the difficulty and uncertainty of pharmaceutical product development and other factors. There may be adverse effects on the Company's business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including as a result of inflation, heightened interest rates, recent and potential future pandemics and other health crises, the Russian invasion of Ukraine and the Israel- Hamas war, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures. These and other risks are described in greater detail under the caption "Risk Factors" and included in LAVA's filings with the Securities and Exchange Commission. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
CONTACTS
Investor Relations
ir@lavatherapeutics.com
LifeSci Advisors (IR/Media)
Joyce Allaire
Jallaire@lifesciadvisors.com
(END) Dow Jones Newswires
March 20, 2024 07:00 ET (11:00 GMT)
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