UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2024
(Commission File No. 001-40241)
LAVA Therapeutics N.V.
(Translation of registrant’s name into English)
Yalelaan 62
3584 CM Utrecht, The Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
LAVA Therapeutics, N.V.
On March 20, 2024, LAVA Therapeutics, N.V. (Company) issued a press release announcing the Company’s financial results for the three months and year ended December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Exhibit 99.1 to this Report on Form 6-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
EXHIBIT LIST
Exhibit |
| Description |
99.1 | | |
| | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| LAVA Therapeutics, N.V. | |
| (Registrant) | |
| | |
Date: March 21, 2024 | By: | /s/ Fred Powell |
| Fred Powell | |
| Chief Financial Officer | |
Exhibit 99.1
LAVA Provides Business Updates and
Reports Fourth Quarter and Year-End Financial Results
| ● | LAVA-1207 progressing in Phase 1/2a study, with pembrolizumab combination expected to begin in Q2 2024 |
| ● | In March 2024, Pfizer paid LAVA $7 million for achieving a clinical milestone for EGFRd2 (PF-08046052/formerly LAVA-1223) |
| ● | LAVA 1266 tracking to Q2 2024 IND submission |
| ● | Strong balance sheet with cash of $95.6 million supports runway into 2026 |
Utrecht, The Netherlands and Philadelphia, PA., USA March 20, 2024 – LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA”, “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma-delta (δ2) T cell engagers, today announced recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2023.
“In 2023, we advanced our portfolio of proprietary Gammabody® programs. LAVA-1207 has enrolled dose level 9 in our Phase 1/2a trial of patients with metastatic castration-resistant prostate cancer (mCRPC). We will soon be enrolling the patients in our pembrolizumab combination arm. We continue to be encouraged by the favorable safety profile and preliminary signs of anti-tumor activity. We plan to provide new data for LAVA-1207 at an upcoming medical conference in the second half of 2024.” said Stephen Hurly, President and Chief Executive Officer of LAVA. “We are also very excited by Pfizer’s clinical progress. They have been a great partner and we look forward to continuing to support them. We plan to submit an IND for LAVA-1266, our investigational asset designed to target CD123 for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), in Q2 2024” continued Mr. Hurly. “These advances represent important steps for our proprietary Gammabody® T-cell engagers as we evaluate their potential to treat cancer. We believe that 2024 will be a significant year and we look forward to sharing our ongoing progress with investors and stakeholders.”
LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conference
Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive prostate cancer cells
| ● | The first-in-human Phase 1/2a clinical trial is enrolling patients in monotherapy and combination arms |
| ● | Completed enrollment in dose level 9 monotherapy arm. |
| ● | Expect to begin enrolling in the dose escalation and dose expansion arm, in combination with KEYTRUDA® (pembrolizumab) in the coming months |
| ● | Evaluating low dose Interleukin-2 (“IL-2”) in the Phase 1/2a study in order to increase the number of Vγ9Vδ2 T cells for engagement by LAVA-1207 |
| ● | With the goal of maintaining low rates of cytokine release syndrome (CRS) and to minimize the risk of CRS events >grade 2, we have introduced premedication and step-dosing to the protocol. |
| ● | Three dose limiting toxicities (DLTs) were observed in patients receiving IL-2 in addition to LAVA-1207, in a cohort with multiple doses of IL-2 per cycle. Since we amended the DLT criteria and initiated step dosing, we have not observed any CRS or DLTs in patients dosed with IL-2 to date. |
| ● | Additional biomarker studies are underway to understand the relationship between δ2 T cells and tumor response, and to investigate other factors that may impact patient selection and show early evidence of anti-tumor activity. |
EGFRd2 (PF-08046052/formerly LAVA-1223) – In Phase 1
Designed to trigger the potent and preferential killing of EGFR-positive tumor cells in solid tumors such as colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC)
| ● | Potential first-in-class agent |
• | Dose escalation trial is underway to evaluate the safety and tolerability of EGFRd2 (PF-08046052) as a monotherapy in advanced EGFR-expressing solid tumors |
• | In March 2024, Pfizer paid LAVA $7 million for achieving a clinical milestone |
LAVA-1266 – IND Submission Expected in Q2 2024
Designed to target CD123 for the treatment of hematological malignancies, including AML and MDS
• | Currently engaged in IND enabling activities |
• | Planning for IND submission in Q2 2024 |
Fourth Quarter and Year-End 2023 Financial Results
| ● | As of December 31, 2023, LAVA had cash, cash equivalents and investments totaling $95.6 million compared to cash, cash equivalents and investments of $132.9 million as of December 31, 2022. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2026. |
| ● | Revenue from contracts with customers was $0.4 million and $2.6 million for the quarters ended December 31, 2023 and 2022, respectively, and $6.8 million and $19.4 million for the years ended December 31, 2023 and 2022, respectively. In connection with the license agreement with Pfizer (formerly Seagen), we recognized $0.3 million in revenue for the three months ended December 31, 2023, related to reimbursement for research activities and initial supply-related stability studies, and $2.6 million for the three months ended December 31, 2022. The decrease of revenue from contracts with customers for the year ended December 31, 2023 compared to 2022 was primarily due to a $15.2 million nonrefundable upfront payment received in 2022 in connection with the Pfizer agreement. |
| ● | Cost of sales of goods and providing services was $0.2 million and zero for the quarters ended December 31, 2023 and 2022, respectively, and $3.5 million and zero for the years ended December 31, 2023 and 2022, respectively. The cost in 2023 was due to the initial drug supply delivery to Pfizer and related stability studies. |
| ● | Research and development expenses were $3.4 million and $10.5 million for the quarters ended December 31, 2023 and 2022, respectively, and $33.8 million and $40.1 million for the years ended December 31, 2023 and 2022, respectively. The decrease for both periods was primarily due to reduced manufacturing scale-up costs, negotiated reduction in contract manufacturing invoices, and reduced clinical trial activities due to the discontinuation of the activities for LAVA-051, announced in June 2023. |
| ● | General and administrative expenses were $2.3 million and $3.6 million for the quarters ended December 31, 2023 and 2022, respectively, and $12.7 million and $14.1 million for the years ended December 31, 2023 and 2022, respectively. The decrease for both periods was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount in 2023. |
| ● | Net loss was $6.5 million and $14.9 million for the quarters ended December 31, 2023 and 2022, respectively, or $0.24 and $0.57 net loss per share for the quarters ended December 31, 2023 and 2022, respectively. Net losses were $42.0 million and $31.9 million for the years ended December 31, 2023 and 2022, respectively, or $1.57 and $1.23 net loss per share for the years ended December 31, 2023 and 2022, respectively. |
LAVA Therapeutics N.V.
Consolidated Interim Statements of Loss
and Comprehensive Loss
(in thousands, except share and per share amounts) (unaudited)
|
|
| Three Months Ended |
| Year Ended | | ||||||||
| | | December 31, | | December 31, | | ||||||||
|
|
| 2023 |
| 2022 |
| 2023 |
| 2022 | | ||||
Revenue: |
|
| |
|
| |
|
| |
|
| |
| |
Revenue from contracts with customers |
| | $ | 353 | | $ | 2,640 | | $ | 6,769 | | $ | 19,391 | |
Cost of sales of goods | | | | — | | | — | | | (2,546) | | | — | |
Cost of providing services | | | | (154) | | | — | | | (936) | | | — | |
Gross profit |
| |
| 199 | |
| 2,640 | |
| 3,287 | |
| 19,391 | |
| | | | | | | | | | | | | | |
Operating expenses: |
| |
|
| |
|
| |
|
| |
|
| |
Research and development |
| |
| (3,360) | |
| (10,540) | |
| (33,814) | |
| (40,105) | |
General and administrative |
| |
| (2,281) | |
| (3,579) | |
| (12,726) | |
| (14,124) | |
Total operating expenses |
| |
| (5,641) | |
| (14,119) | |
| (46,540) | |
| (54,229) | |
| | | | | | | | | | | | | | |
Operating loss |
| |
| (5,442) | |
| (11,479) | |
| (43,253) | |
| (34,838) | |
Interest income (expense), net |
| |
| 846 | |
| 471 | |
| 2,970 | |
| 257 | |
Foreign currency exchange (loss) gain, net |
| |
| (1,841) | |
| (3,840) | |
| (1,412) | |
| 2,923 | |
Total non-operating income |
| |
| (995) | |
| (3,369) | |
| 1,558 | |
| 3,180 | |
| | | | | | | | | | | | | | |
Loss before income tax |
| |
| (6,437) | |
| (14,848) | |
| (41,695) | |
| (31,658) | |
Income tax expense |
| |
| (61) | |
| (67) | |
| (279) | |
| (249) | |
Loss for the year |
| | $ | (6,498) | | $ | (14,915) | | $ | (41,974) | | $ | (31,907) | |
Items that may be reclassified to profit or loss | | | | | | | | | | | | | | |
Foreign currency translation 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® 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 Vγ9Vδ2 (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®(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® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA
Gammabody® 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®, 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 γδ2 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® 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