Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
-- Alignment reached with U.S. Food and Drug Administration on key elements of the approval pathway for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer --
-- Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer --
-- Matt Pulisic joined the company as its new Chief Financial Officer --
-- Closing of $10.5 Million Underwritten Offering of Common Stock --
-- $30.9 million in cash, cash equivalents and short-term investments --
WESTLAKE VILLAGE, Calif., March 28, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2024 financial results and business updates.
"Our progress in the fourth quarter of 2024 and into 2025 marks a pivotal period for patients, our company, and our investors," said Thomas Zindrick, President, CEO and Chairman of Genelux. "We are pleased with the continued progress and promise of our clinical development program. The strengthening of our management team, with the addition of Matt, and of our balance sheet, with our recent financing, further positions the Company to execute on our mission to transform the lives of patients who need it most."
Pipeline Highlights
OnPrime/GOG-3076 Phase 3 Registrational Trial Update
The Company continues to enroll patients in the ongoing pivotal Phase 3 OnPrime/GOG-3076 registration trial (Phase 3 trial) in platinum resistant/refractory ovarian cancer (PRROC), with the primary endpoint of progression free survival $(PFS)$ (Clinicaltrials.gov identifier NCT05281471), and continues to have productive discussions with the U.S. Food and Drug Administration (FDA).
The Company recently concluded a productive Type D meeting with the FDA for Olvi-Vec in the treatment of PRROC. In response to a question seeking the FDA's guidance on their expectations regarding a confirmatory trial using the ongoing Phase 3 trial results, the FDA responded that "As stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval." The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps. This could potentially avoid the need for conducting a separate confirmatory study.
The trial will enroll a sufficient number of patients to achieve 127 events, with the primary endpoint of PFS and with secondary endpoints including OS. The Company anticipates reporting topline data in the first half of 2026.
Recurrent Lung Cancer Trials: Systemic Administration of Olvi-Vec Update
Phase 1b/2 Olvi-Vec-SCLC-202 has generated preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the ongoing Phase 1b/2 clinical trial of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. The trial is co-sponsored by the Company and its licensing partner, Newsoara BioPharma Co., Ltd. (Newsoara).
-- Systemic administration of Olvi-Vec in the initial dose escalation
cohorts achieved a 71% disease control rate (5/7), with two partial
responders. All participants with disease control experienced a reduction
in all target lesions, with one participant achieving a tumor reduction
of approximately 79%.
-- Additionally, three participants, including one individual with three
prior lines of treatment, achieved stable disease at lower dose cohorts,
with tumor size reductions ranging between 24% to 29.2%.
-- Olvi-Vec was generally well-tolerated with a favorable safety profile.
Participant enrollment into dose escalation cohorts continues to
investigate safety and the recommended intravenous dose of Olvi-Vec for
Phase 2 portion of the trial, with updated interim results anticipated in
the second half of 2025.
Phase 2 VIRO-25 is actively enrolling recurrent non-small cell lung cancer (NSCLC) patients (NCT06463665), with interim data anticipated in second half of 2025.
Business Updates
Chief Financial Officer
Matt Pulisic has joined the Company as its new Chief Financial Officer, effective January 30, 2025. Mr. Pulisic is an accomplished, senior executive with over 19 years of finance and commercial experience in the biopharmaceutical industry, having worked across the United States, Europe, and Asia. He is recognized for his expertise in financial leadership, corporate strategy and operational execution.
Underwritten Offering of Common Stock
On March 26, 2025, the Company closed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share. The gross proceeds from the offering are expected to be $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The net proceeds from the offering are to be used for working capital and for general corporate purposes, including the continued clinical development of Olvi-Vec.
Fourth Quarter and 2024 Financial Results
Cash, cash equivalents and short-term investments were $30.9 million as of December 31, 2024. The Company expects its cash, cash equivalents and short-term investments as of December 31, 2024 will provide runway into the first quarter of 2026.
Research and development expenses were $19.0 million and $12.8 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $6.2 million. Significant variations between periods are primarily a result of a $4.5 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with the Company's Phase 3 On Prime Registration trial in 2024 and Phase 2 clinical trial for NSCLC, which the Company's partner, Newsoara, is obligated to fully reimburse per the terms of their agreement; and a $1.2 million increase in employee compensation in 2024, primarily related to new employee hires in 2024.
General and administrative expenses were $12.7 million and $11.6 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $1.1 million. Significant variations between periods are primarily a result of a $0.2 million increase in employee compensation in 2024, a $0.8 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024, and a $0.4 million increase in consulting and contract labor expenses in 2024, primarily resulting from increased accounting and finance costs in 2024, partially offset by a $0.5 million decrease in professional services, primarily resulting from the decrease in legal expenses in 2024.
Net loss was $29.9 million or $0.95 per share for the year ending December 31, 2024, as compared to $28.3 million or $1.16 for the year ending December 31, 2023.
About Genelux Corporation
Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and, VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. Additionally, Olvi-Vec currently is being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open label Ph1b evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet in recurrent small-cell lung cancer. The core of Genelux's discovery and development efforts revolves around its' proprietary CHOICE$(TM)$ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn.
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, the planned timing of Genelux's data results in its ongoing clinical trials and continued development of Olvi-Vec, the potential capabilities advantages, safety and efficacy of Olvi-Vec and the potential regulatory approval pathway 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 Securities and Exchange Commission. All forward-looking statements contained in this press release
speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
Investor and Media Contacts
Ankit Bhargava, MD
Allele Communications, LLC
genelux@allelecomms.com
Source: Genelux Corporation
Genelux Corporation
Balance Sheets
(In thousands, except for share amounts and par value
data)
December 31,
------------------------
2024 2023
ASSETS
Current Assets
Cash and cash equivalents $ 8,565 $ 9,418
Short-term investments 22,330 13,773
Prepaid expenses and other current assets 653 1,012
-------- --------
Total Current Assets 31,548 24,203
-------- --------
Property and equipment, net 1,316 1,170
Right of use assets 1,760 2,428
Other assets 92 92
Total Other Assets 3,168 3,690
-------- --------
TOTAL ASSETS $ 34,716 $ 27,893
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities
Accounts payable and accrued expenses $ 5,570 $ 3,784
Accrued payroll and payroll taxes 1,004 2,117
Lease liabilities, current portion 329 653
Total Current Liabilities 6,903 6,554
-------- --------
Lease liabilities, long-term portion 1,539 1,866
-------- --------
Total Liabilities 8,442 8,420
-------- --------
Commitments and Contingencies
Shareholders' Equity
Preferred stock, par value $0.001, 10,000,000
shares authorized;
no shares issued and outstanding,
respectively; - -
Common stock, par value $0.001, 200,000,000
shares authorized;
34,728,140 and 26,788,986 shares issued and
outstanding 35 27
Treasury stock, 433,333 shares, at cost (433) (433)
Additional paid-in capital 278,001 241,389
Accumulated other comprehensive income 64 14
Accumulated deficit (251,393) (221,524)
-------- --------
Total Shareholders' Equity 26,274 19,473
-------- --------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 34,716 $ 27,893
======== ========
The accompanying notes are an integral part of these
financial statements.
Genelux Corporation
Statements of Operations
(in thousands, except for share amounts and per share
data)
Years Ended
December 31,
----------------------------
2024 2023
Revenues $ 8 $ 170
---------- ----------
Operating expenses:
Research and development 18,998 12,767
General and administrative 12,706 11,568
---------- ----------
Total operating expenses 31,704 24,335
---------- ----------
Loss from operations (31,696) (24,165)
---------- ----------
Other income (expenses):
Interest income 1,457 244
Gain on extinguishment of accounts
payable 370 -
Interest expense - (173)
Debt discount amortization - (649)
Financing costs - (3,152)
Debt extinguishment costs (402)
Total other income (expenses), net 1,827 (4,132)
---------- ----------
NET LOSS $ (29,869) $ (28,297)
========== ==========
LOSS PER COMMON SHARE - BASIC AND DILUTED $ (0.95) $ (1.16)
========== ==========
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING -
BASIC AND DILUTED 31,450,727 24,429,278
========== ==========
The accompanying notes are an integral part of these
financial statements.
Genelux Corporation
Statements of Comprehensive Loss
(in thousands)
Years Ended
December 31,
----------------------
2024 2023
Net loss $(29,869) $(28,297)
Other comprehensive loss:
Net unrealized gain on short and long-term
investments 50 12
Comprehensive loss $(29,819) $(28,285)
======= =======
The accompanying notes are an integral part of these
financial statements.
Genelux Corporation
Statements of Shareholders' Equity (Deficit)
(in thousands, except share amounts)
Accumulated
Other
Treasury
Preferred Stock Common Stock Stock Additional Comprehensive Accumulated
---------------------- -------------------- --------- ------
Paid-in
Shares Amount Shares Amount Shares Amount Capital Income (Loss) Deficit Total
------------ -------- ---------- -------- --------- ------ ------------ --------------- ------------- -----------
Balance, December 31,
2022 22,094,889 $ 22 9,126,726 $ 9 (433,333) $(433) $ 154,401 $ 2 $ (189,784) $(35,783)
Stock compensation - - - - - - 2,515 - - 2,515
Unrealized gain on
short-term
investments - - - - - - - 12 - 12
Issuance of common
shares upon the
closing of the
initial public
offering, net of
offering costs - - 2,653,000 3 - - 12,629 - - 12,632
Issuance of common
shares upon the
closing of private
financings, net of
offering costs - - 1,292,079 2 - - 25,140 - - 25,142
Issuance of common
shares upon
conversion of
preferred stock (22,094,889) (22) 8,359,143 8 - - 14 - - -
Issuance of common
shares upon
conversion of
convertible
notes payable,
accrued interest
and loan fees - - 4,137,760 4 - - 29,970 - - 29,974
Issuance of common
shares upon
conversion of
preferred
stock dividends
payable - - 272,101 - - - 3,443 - (3,443) -
Fair value of vested
restricted stock
units - - 113,500 - - - 940 - - 940
Cost of stock option
repricing - - - - - - 2,689 - - 2,689
Reclassification of
warrant liabilities
upon the closing of
the initial public
offering - - - - - - 169 - - 169
Fair value of
warrants issued in
connection with the
the conversion of
convertible notes
payable - - - - - - 3,152 - - 3,152
Conversion of notes
payable-shareholders
and accrued
interest - - 73,134 - - - 1,865 - - 1,865
Issuance of common
shares upon exercise
of stock options - - 232,787 - - - 1,474 - - 1,474
Issuance of common
shares upon exercise
of stock warrants - - 528,756 1 - - 2,988 - - 2,989
Net loss during the
year ended December
31, 2023 - - - - - - - - (28,297) (28,297)
----------- --- ---------- ---- -------- ---- -------- ---- --------- -------- -------
Balance, December 31,
2023 - - 26,788,986 27 (433,333) (433) 241,389 14 (221,524) 19,473
Stock compensation - - - - - - 5,738 - - 5,738
Unrealized gain on
short and long-term
investments - - - - - - - 50 - 50
Fair value of vested
restricted stock
units - - 303,389 - - - 2,044 - - 2,044
Cost of stock option
modifications and
repricing - - - - - - 332 - - 332
Issuance of common
shares for cash and
warrants, net of
costs - - 7,505,460 8 - - 27,685 - - 27,693
Issuance of common
shares in connection
with the Company's
equity award
programs - - 53,818 - - - 125 - - 125
Issuance of common
shares upon exercise
of stock warrants - - 76,487 - - - 688 - - 688
Net loss during the
year ended December
31, 2024 - - - - - - - - (29,869) (29,869)
----------- --- ---------- ---- -------- ---- -------- ---- --------- -------- -------
Balance, December 31,
2024 - $ - 34,728,140 $ 35 (433,333) $(433) $ 278,001 $ 64 $ (251,393) $ 26,274
=========== === ========== ==== ======== ==== ======== ==== ========= ======== =======
The accompanying notes are an integral part of these
financial statements.
Genelux Corporation
Statements of Cash Flows
(In thousands)
Years Ended
December 31,
----------------------
2024 2023
Cash Flows from Operating Activities
------------------------------------------------
Net loss $(29,869) $(28,297)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation expense 235 499
Net amortization of premiums and discounts on
short-term investments (757) (62)
Right-of-use asset 668 519
Amortization of debt discount - 649
Stock compensation 5,738 2,515
Fair value of restricted stock units 2,044 940
Cost of stock option modifications and
repricing 332 2,689
Gain on extinguishment of accounts payable (370) -
Debt extinguishment costs - 402
Fair value of warrants issued in connection
with the conversion of convertible notes
payable - 3,152
Changes in Assets and Liabilities
(Increase) Decrease in:
Prepaid expenses and other assets 359 483
(Decrease) Increase in:
Accounts payable and accrued expenses 2,156 (2,358)
Accrued payroll and payroll taxes (1,113) (735)
Accrued interest payable - 22
Deferred revenue - (170)
Lease liability (651) (523)
Net cash used in operating activities (21,228) (20,275)
------- -------
Cash Flows from Investing Activities
------------------------------------------------
Purchases of property and equipment (381) (1,025)
Purchase of short and long-term investments (29,000) (13,699)
Proceeds from sales and maturities of short and
long-term investments 21,250 -
Net cash used in investing activities (8,131) (14,724)
------- -------
Cash Flows from Financing Activities
------------------------------------------------
Proceeds from notes payable - shareholders - 900
Repayment of notes payable - shareholders - (685)
Payment of deferred offering costs - (303)
Proceeds from common stock issued in connection
with the Company's equity award programs 125 -
Proceeds from the exercise of stock options - 1,474
Proceeds from the exercise of stock warrants 688 2,989
Proceeds from common stock issued for cash in
connection with the closing of the IPO - 14,503
Proceeds from common stock issued for cash in
connection with the closing of private
financings - 25,142
Proceeds from common stock issued for cash in
connection with the closing of a second public
offering 27,693 -
Net cash provided by financing activities 28,506 44,020
------- -------
Net increase (decrease) in cash and cash
equivalents (853) 9,021
Cash and cash equivalents at the beginning of
year 9,418 397
Cash and cash equivalents at the end of year $ 8,565 $ 9,418
======= =======
Supplemental cash flows disclosures:
------------------------------------------------
Interest paid $ - $ 72
======= =======
Taxes paid $ - $ -
======= =======
Supplemental non-cash financing disclosures:
------------------------------------------------
Effect of the extension of right-of-use asset
and operating lease $ - $ 1,612
======= =======
Reclassification of deferred offering costs to
shareholders' equity $ - $ 1,871
======= =======
Reclassification of warrant liabilities to
shareholders' equity $ - $ 169
======= =======
Conversion of convertible notes payable, accrued
interest and loan fees to shareholders' equity $ - $ 29,974
======= =======
Conversion of preferred stock to common stock $ - $ 22
======= =======
Conversion of dividends payable to shareholders'
equity $ - $ 3,443
======= =======
Conversion of notes payable-shareholders and
accrued interest to shareholders' equity $ - $ 1,463
======= =======
Unrealized gain on investments $ 50 $ 12
======= =======
The accompanying notes are an integral part of these
financial statements.
(END) Dow Jones Newswires
March 28, 2025 16:10 ET (20:10 GMT)
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.