Genelux Corporation Reports Second Quarter 2024 Financial Results and Provides General Business Updates
“The past quarter has continued to be transformative for the company as we completed a key financing expected to provide runway through three trial readouts, including our ongoing Phase 3 trial in platinum resistant/refractory ovarian cancer,” said
The Company anticipates announcing interim results from the Phase 2 trial in recurrent non-small cell lung cancer by mid-2025, with interim data from our Phase 1b trial in recurrent small cell lung cancer expected later this year. Both trials involve the intravenous administration of Olvi-Vec and the re-challenging of patients who have previously failed platinum-based chemotherapy. These designs are based on a prior clinical trial that demonstrated the benefits of intravenously administered Olvi-Vec in patients with lung disease (either primary or metastatic), as well as on our Phase 2 data in platinum-resistant/refractory ovarian cancer (PRROC).
Pipeline Highlights
The ongoing Phase 3 OnPrime/GOG-3076 registrational trial in PRROC continues to enroll patients with over 23 sites activated (NCT05281471). The Company anticipates topline results in the second half of 2025.
Business Updates
In
Second Quarter 2024 Financial Results
Cash, cash equivalents, short and long-term investments were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were flat year-over year at
Net loss was
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
genelux@allelecomms.com
Source:
| Condensed Balance Sheets | ||||||
| (in thousands, except for share amounts and par value data) | ||||||
| 2024 | 2023 | |||||
| ASSETS | (Unaudited) | |||||
| Current Assets | ||||||
| Cash and cash equivalents | $ | 7,858 | $ | 9,418 | ||
| Short-term investments | 25,778 | 13,773 | ||||
| Prepaid expenses and other current assets | 1,234 | 1,012 | ||||
| Total Current Assets | 34,870 | 24,203 | ||||
| Property and equipment, net | 1,306 | 1,170 | ||||
| Right of use assets | 2,098 | 2,428 | ||||
| Long-term investments | 6,813 | - | ||||
| Other assets | 92 | 92 | ||||
| Total Other Assets | 10,309 | 3,690 | ||||
| TOTAL ASSETS | $ | 45,179 | $ | 27,893 | ||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
| Current Liabilities | ||||||
| Accounts payable and accrued expenses | $ | 4,786 | $ | 3,784 | ||
| Accrued payroll and payroll taxes | 517 | 2,117 | ||||
| Lease liabilities, current portion | 500 | 653 | ||||
| Total Current Liabilities | 5,803 | 6,554 | ||||
| Lease liabilities, long-term portion | 1,707 | 1,866 | ||||
| Total Liabilities | 7,510 | 8,420 | ||||
| Shareholders' Equity | ||||||
| Preferred stock, par value |
||||||
| no shares issued and outstanding, respectively; | - | - | ||||
| Common stock, par value |
||||||
| 34,512,642 and 26,788,986 shares issued and outstanding, respectively | 35 | 27 | ||||
| (433 | ) | (433 | ) | |||
| Additional paid-in capital | 274,028 | 241,389 | ||||
| Accumulated other comprehensive income (loss) | (11 | ) | 14 | |||
| Accumulated deficit | (235,950 | ) | (221,524 | ) | ||
| Total Shareholders' Equity | 37,669 | 19,473 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 45,179 | $ | 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 | Six Months Ended | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||
| Revenues | $ | - | $ | - | $ | 8 | $ | 170 | |||||
| Operating expenses: | |||||||||||||
| Research and development | 4,417 | 2,943 | 8,427 | 5,788 | |||||||||
| General and administrative | 2,475 | 2,452 | 6,588 | 6,239 | |||||||||
| Total operating expenses | 6,892 | 5,395 | 15,015 | 12,027 | |||||||||
| Loss from operations | (6,892 | ) | (5,395 | ) | (15,007 | ) | (11,857 | ) | |||||
| Other income (expenses): | |||||||||||||
| Interest income | 316 | - | 581 | - | |||||||||
| Interest expense | - | (24 | ) | - | (167 | ) | |||||||
| Debt discount amortization | - | - | - | (649 | ) | ||||||||
| Financing costs | - | - | - | (3,110 | ) | ||||||||
| Debt extinguishment costs | (402 | ) | (402 | ) | |||||||||
| Total other income (expenses), net | 316 | (426 | ) | 581 | (4,328 | ) | |||||||
| NET LOSS | $ | (6,576 | ) | $ | (5,821 | ) | $ | (14,426 | ) | $ | (16,185 | ) | |
| LOSS PER COMMON SHARE - BASIC AND DILUTED | $ | (0.22 | ) | $ | (0.23 | ) | $ | (0.51 | ) | $ | (0.72 | ) | |
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - | |||||||||||||
| BASIC AND DILUTED | 29,689,344 | 25,068,334 | 28,308,046 | 22,334,311 | |||||||||
| The accompanying notes are an integral part of these condensed financial statements. | |||||||||||||
| Condensed Statements of Comprehensive Loss | |||||||||||||
| (in thousands) | |||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||
| Net loss | $ | (6,576 | ) | $ | (5,821 | ) | $ | (14,426 | ) | $ | (16,185 | ) | |
| Other comprehensive loss: | |||||||||||||
| Net unrealized loss on short and long-term investments | (6 | ) | - | (25 | ) | - | |||||||
| Comprehensive loss | $ | (6,582 | ) | $ | (5,821 | ) | $ | (14,451 | ) | $ | (16,185 | ) | |
| The accompanying notes are an integral part of these condensed financial statements. | |||||||||||||
Source: Genelux Corporation