Genelux Corporation Reports Third Quarter 2024 Financial Results and Provides General Business Updates
GNLX 11.14.2024
Drug:UNKNOWN Olvi-Vec
Diseases:recurrent advanced or metastatic non-small cell lung cancer (NSCLC)
Diseases:recurrent small cell lung cancer (SCLC)
About Gravity Analytica
The Company initiated its second lung cancer trial, a US-based, Phase 2 trial (VIRO-25) treating patients with recurrent advanced or metastatic non-small cell lung cancer (NSCLC) with Olvi-Vec, followed by platinum-doublet chemotherapy + immune checkpoint inhibitor. Additionally, a Phase 1b/2 lung cancer trial is ongoing in recurrent small cell lung cancer (SCLC) in
Both trials utilize Olvi-Vec delivered intravenously to treat patients who have previously failed platinum-based chemotherapy. The trials are designed based on earlier clinical results, including Olvi-Vec demonstrating (i) positive outcomes in patients with primary or metastatic lung cancer when delivered intravenously and (ii) clinical reversal of platinum resistance and refractoriness in a Phase 2 trial in platinum-resistant/refractory ovarian cancer (PRROC).
"Over the past quarter, we marked another important step forward in our efforts to advance the systemic delivery of Olvi-Vec and to demonstrate the re-sensitization to platinum-based chemotherapy in multiple tumor types," said
Pipeline Highlights
The Company’s clinical program is designed to position Olvi-Vec as an ideal backbone of combination cancer therapy due to its unique mechanism of action to modify the tumor immune microenvironment. Building on the promising results from our previous clinical trials, we see the potential of Olvi-Vec to induce platinum re-sensitization as a strategy to enhance patient response and extend survival in platinum-resistant populations. In addition, the VIRO-25 trial expands the program to include combination therapies with immune checkpoint inhibitors as we aim to unlock synergistic activity that amplify the immune response against tumors.
- Patient enrollment continues to progress in the Phase 3 OnPrime/GOG-3076 trial for PRROC, now active at over 25 sites (NCT05281471). Topline results are anticipated in the latter half of 2025.
- Phase 2 VIRO-25 is actively enrolling recurrent NSCLC patients (NCT06463665), with interim data expected by mid-2025.
- Interim results from the Phase 1b portion of a Phase 1b/2 SCLC trial projected by end of 2024.
Third Quarter 2024 Financial Results
Cash and cash equivalents, and short and long-terminvestmentswere
Research and development (R&D) expenses
General and administrative (G&A) expenseswere
Net losswas
About
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations, the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the
Investor and Media Contacts
Source:
| Condensed Balance Sheets | |||||||
| (in thousands, except for share amounts and par value data) | |||||||
| 2024 | 2023 | ||||||
| ASSETS | (Unaudited) | ||||||
| Current Assets | |||||||
| Cash and cash equivalents | $ | 6,102 | $ | 9,418 | |||
| Short-term investments | 27,955 | 13,773 | |||||
| Prepaid expenses and other current assets | 1,910 | 1,012 | |||||
| Total Current Assets | 35,967 | 24,203 | |||||
| Property and equipment, net | 1,278 | 1,170 | |||||
| Right of use assets | 1,930 | 2,428 | |||||
| Long-term investments | 1,003 | - | |||||
| Other assets | 92 | 92 | |||||
| Total Other Assets | 4,303 | 3,690 | |||||
| TOTAL ASSETS | $ | 40,270 | $ | 27,893 | |||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
| Current Liabilities | |||||||
| Accounts payable and accrued expenses | $ | 4,454 | $ | 3,784 | |||
| Accrued payroll and payroll taxes | 686 | 2,117 | |||||
| Lease liabilities, current portion | 415 | 653 | |||||
| Total Current Liabilities | 5,555 | 6,554 | |||||
| Lease liabilities, long-term portion | 1,624 | 1,866 | |||||
| Total Liabilities | 7,179 | 8,420 | |||||
| Shareholders' Equity | |||||||
| Preferred stock, par value | |||||||
| no shares issued and outstanding, respectively; | - | - | |||||
| Common stock, par value | |||||||
| 34,538,185 and 26,788,986 shares issued and outstanding | 35 | 27 | |||||
| (433 | ) | (433 | ) | ||||
| Additional paid-in capital | 275,782 | 241,389 | |||||
| Accumulated other comprehensive income | 124 | 14 | |||||
| Accumulated deficit | (242,417 | ) | (221,524 | ) | |||
| Total Shareholders' Equity | 33,091 | 19,473 | |||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 40,270 | $ | 27,893 | |||
| The accompanying notes are an integral part of these condensed financial statements. | |||||||
| Condensed Statements of Operations | |||||||||||||||
| (in thousands, except for share amounts and per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||
| Revenues | $ | - | $ | - | $ | 8 | $ | 170 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 4,051 | 2,819 | 12,478 | 8,607 | |||||||||||
| General and administrative | 2,890 | 2,488 | 9,478 | 8,727 | |||||||||||
| Total operating expenses | 6,941 | 5,307 | 21,956 | 17,334 | |||||||||||
| Loss from operations | (6,941 | ) | (5,307 | ) | (21,948 | ) | (17,164 | ) | |||||||
| Other income (expenses): | |||||||||||||||
| Interest income | 474 | 4 | 1,055 | 4 | |||||||||||
| Interest expense | - | - | - | (167 | ) | ||||||||||
| Debt discount amortization | - | - | - | (649 | ) | ||||||||||
| Financing costs | - | (42 | ) | - | (3,152 | ) | |||||||||
| Debt extinguishment costs | - | (402 | ) | ||||||||||||
| Total other income (expenses), net | 474 | (38 | ) | 1,055 | (4,366 | ) | |||||||||
| NET LOSS | $ | (6,467 | ) | $ | (5,345 | ) | $ | (20,893 | ) | $ | (21,530 | ) | |||
| LOSS PER COMMON SHARE - BASIC AND DILUTED | $ | (0.19 | ) | $ | (0.20 | ) | $ | (0.69 | ) | $ | (0.91 | ) | |||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - | |||||||||||||||
| BASIC AND DILUTED | 34,532,355 | 26,210,068 | 30,405,615 | 23,640,995 | |||||||||||
| The accompanying notes are an integral part of these condensed financial statements. | |||||||||||||||
| Condensed Statements of Comprehensive Loss | |||||||||||||||
| (in thousands) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||||
| Net loss | $ | (6,467 | ) | $ | (5,345 | ) | $ | (20,893 | ) | $ | (21,530 | ) | |||
| Other comprehensive loss: | |||||||||||||||
| Net unrealized gain on short and long-term investments | 135 | - | 110 | - | |||||||||||
| Comprehensive loss | $ | (6,332 | ) | $ | (5,345 | ) | $ | (20,783 | ) | $ | (21,530 | ) | |||
| The accompanying notes are an integral part of these condensed financial statements. | |||||||||||||||
Source: Genelux Corporation