Genelux Corporation (NASDAQ: GNLX), a late clinical-stage
immuno-oncology company, today announced financial results for the
second quarter of 2023 and provided general business updates.
“We’ve made significant progress in the second
quarter across our business, but most importantly in securing
additional capital to fund operations through our projected key
clinical milestones, including the initial readout of our
OnPrime/GOG-3076 Phase 3 registrational trial,” said Thomas
Zindrick, President, Chairman and CEO of Genelux. “Looking ahead,
we remain focused on Olvi-Vec, which is on track for clinical
trials across multiple indications and building the commercial
infrastructure in preparation for the potential success of our
Phase 3 trial and beyond.”
Pipeline Highlights
The Journal of the American Medical Association
(JAMA) Oncology published positive topline data from Phase 2
VIRO-15 trial evaluating Olvi-Vec in Platinum-Resistant or
Refractory Ovarian Cancer. The Article was featured on JAMA
Oncology’s podcast with lead investigator, Robert W. Holloway,
MD.
Genelux is advancing Olvi-Vec for the treatment
of various cancer indications led by its ongoing OnPrime/GOG-3076
trial, evaluating the efficacy and safety of Olvi-Vec in patients
with platinum-resistant/refractory ovarian cancer.
Genelux and its licensing partner, Newsoara
BioPharma Co., Ltd., also commenced a Phase 1b/2 study of Olvi-Vec
in NSCLC, with the first patient having been dosed. Newsoara is
conducting the trial in Greater China and Genelux will have
worldwide developmental and commercial rights (excluding Greater
China) to all data generated from clinical trials of Olvi-Vec in
China.
Genelux and TVAX Biomedical, Inc. announced the
issuance of a United States patent covering the combination of an
adoptive T cell therapy/oncolytic viral cancer treatment that is
exclusively licensed to V2ACT Therapeutics™, LLC, a joint venture
between Genelux and TVAX. The patent expiry, prior to any patent
term extension, will be in 2036 and will add substantial
intellectual property protection for V2ACT Immunotherapy.
Business Updates
Genelux was added to the broad-market Russell
3000® Index and small-cap Russell 2000® Index on June 26, 2023 at
the conclusion of the 2023 Russell indexes annual
reconstitution.
Genelux announced key leadership appointments to
further position the company for a potential future filing of a
biologics license application. These appointments included two key
management promotions, as well as the addition of two new members
to its leadership team. Joseph Cappello, Ph.D., who previously
served as the Company’s Vice President of Pharmaceutical
Development, was promoted to Chief Technical Officer. Tony Yu,
Ph.D., formerly the Company’s Vice President of Clinical Trial
Operations, was promoted to Senior Vice President of Clinical
Development. Ralph Smalling, MS joined the Company as Head of
Regulatory Affairs and Caroline Jewett joined the Company as Head
of Quality.
Second Quarter 2023 Financial
Results
Cash, Cash Equivalents and Investments: At June
30, 2023, the Company had cash on hand in the amount of $27.1
million. During the six months ended June 30, 2023, the Company
closed its initial public offering (IPO) and two private placements
and received $36.1 million of gross proceeds from the offerings.
The Company also received commitments through the private
placements in which the Company will receive an additional $27.5
million subsequent to June 2023, on or before November 15,
2023, at the same price as the initial closing investments in the
private placements. Due to the funds received through these
offerings, and the conversion of preferred stock and convertible
notes payable upon the closing of the IPO, the Company had a
shareholders’ equity of $22.3 million at June 30, 2023. The Company
expects its cash on hand at June 30, 2023, together with the $27.5
million of future commitments from the private placements, will
last until the first quarter of 2026.
R&D Expenses: Research and development
expenses were $2.9 million for the second quarter of 2023, as
compared to $1.8 million for the second quarter of 2022. The
increase was primarily due to additional clinical trial expenses of
the Phase 3 trial.
G&A Expenses: General and administrative
expenses were $2.5 million for the second quarter of 2023, as
compared to $1.0 million for the second quarter of 2022. The
increase was primarily due to additional employee-related costs,
including new employee hires, stock compensation expenses and an
increase in professional service expenses related to being a newly
publicly traded company.
Net Loss: Net loss was $5.8 million for the
second quarter of 2023, as compared to a net loss of $2.8 million
for the second quarter of 2022.
About Genelux
CorporationGenelux 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. The
Company's most advanced product candidate, Olvi-Vec (olvimulogene
nanivacirepvec), is a proprietary, modified strain of the vaccinia
virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a
multi-center, randomized, open-label Phase 3 registrational trial
evaluating the efficacy and safety of Olvi-Vec in combination with
platinum-doublet + bevacizumab compared to platinum-doublet +
bevacizumab in patients with platinum-resistant/refractory ovarian
cancer. The core of Genelux' discovery and development efforts
revolves around the company's proprietary CHOICE™ 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 StatementsThis
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, the execution
of its corporate strategy, the extension of Genelux’s cash runway
and how long our current cash and cash commitments will fund our
operations, whether the additional capital secured will be
sufficient to support our key clinical milestones, clinical trials
for Olvi-Vec and their potential success, the extent of
intellectual property protection provided by the new patent
licensed to V2ACT Therapeutics, LLC, the potential future filing of
a biologics license application, and the commitment of additional
funds. 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’ 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, MDAllele Communications,
LLCgenelux@allelecomms.com
Source: Genelux Corporation
|
|
|
Genelux Corporation |
Condensed Balance Sheets |
(In thousands, except for share amounts and par value data) |
|
|
|
|
June 30, |
December 31, |
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
ASSETS |
|
|
Current Assets |
|
|
Cash |
$ |
27,140 |
|
$ |
397 |
|
Prepaid expenses and other current assets |
|
1,543 |
|
|
1,495 |
|
Total Current Assets |
|
28,683 |
|
|
1,892 |
|
|
|
|
Property and equipment, net |
|
878 |
|
|
644 |
|
Right of use asset |
|
1,710 |
|
|
1,335 |
|
Deferred offering costs |
|
- |
|
|
1,568 |
|
Other assets |
|
92 |
|
|
92 |
|
Total Other Assets |
|
2,680 |
|
|
3,639 |
|
|
|
|
TOTAL ASSETS |
$ |
31,363 |
|
$ |
5,531 |
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) |
|
|
Current Liabilities |
|
|
Accounts payable and accrued expenses |
$ |
4,484 |
|
$ |
6,775 |
|
Accrued compensation |
|
2,684 |
|
|
2,852 |
|
Accrued interest payable |
|
- |
|
|
1,178 |
|
Accrued interest payable - director and shareholders |
|
60 |
|
|
3,817 |
|
Deferred revenue |
|
- |
|
|
170 |
|
Warrant liabilities |
|
- |
|
|
169 |
|
Lease liability, current portion |
|
585 |
|
|
266 |
|
Notes payable - shareholders, net of debt discount of $108 in
2022 |
|
- |
|
|
992 |
|
Convertible notes payable - shareholders, current portion, |
|
|
including $65 and $105 past due, respectively |
|
65 |
|
|
15,407 |
|
Total Current Liabilities |
|
7,878 |
|
|
31,626 |
|
|
|
|
Long-term Liabilities |
|
|
Lease liability, long-term portion |
|
1,229 |
|
|
1,164 |
|
Convertible notes payable, net of debt discount of $541 in
2022 |
|
- |
|
|
8,524 |
|
Total Long-term Liabilities |
|
1,229 |
|
|
9,688 |
|
|
|
|
Total Liabilities |
|
9,107 |
|
|
41,314 |
|
|
|
|
Shareholders' Equity (Deficit) |
|
|
Preferred stock, Series A through K, par value $0.001, 10,000,000
shares |
|
|
authorized; no shares and 22,094,889 shares issued and outstanding,
respectively; |
|
- |
|
|
22 |
|
Common stock, par value $0.001, 200,000,000 shares authorized; |
|
|
25,855,511 and 9,126,726 shares issued and outstanding,
respectively |
|
26 |
|
|
9 |
|
Treasury stock, 433,333 shares, at cost |
|
(433 |
) |
|
(433 |
) |
Additional paid-in capital |
|
232,073 |
|
|
154,401 |
|
Accumulated other comprehensive income |
|
2 |
|
|
2 |
|
Accumulated deficit |
|
(209,412 |
) |
|
(189,784 |
) |
Total Shareholders' Equity (Deficit) |
|
22,256 |
|
|
(35,783 |
) |
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
(DEFICIT) |
$ |
31,363 |
|
$ |
5,531 |
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
financial statements. |
|
|
|
Genelux Corporation |
Condensed Statements of Operations |
(in thousands, except for share amounts and per share data) |
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
(Unaudited) |
|
(Unaudited) |
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
|
$ |
170 |
|
$ |
- |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
2,943 |
|
|
1,827 |
|
|
|
5,788 |
|
|
4,196 |
|
General and administrative |
|
2,452 |
|
|
972 |
|
|
|
6,239 |
|
|
2,067 |
|
Total operating expenses |
|
5,395 |
|
|
2,799 |
|
|
|
12,027 |
|
|
6,263 |
|
|
|
|
|
|
|
Loss from operations |
|
(5,395 |
) |
|
(2,799 |
) |
|
|
(11,857 |
) |
|
(6,263 |
) |
|
|
|
|
|
|
Other expenses: |
|
|
|
|
|
Interest expense |
|
(24 |
) |
|
(285 |
) |
|
|
(167 |
) |
|
(573 |
) |
Debt discount amortization |
|
- |
|
|
(50 |
) |
|
|
(649 |
) |
|
(99 |
) |
Financing costs |
|
- |
|
|
- |
|
|
|
(3,110 |
) |
|
- |
|
Debt extinguishment costs |
|
(402 |
) |
|
- |
|
|
|
(402 |
) |
|
- |
|
Gain on forgiveness of PPP loan payable |
|
- |
|
|
314 |
|
|
|
- |
|
|
314 |
|
Total other expenses |
|
(426 |
) |
|
(21 |
) |
|
|
(4,328 |
) |
|
(358 |
) |
|
|
|
|
|
|
NET LOSS |
$ |
(5,821 |
) |
$ |
(2,820 |
) |
|
$ |
(16,185 |
) |
$ |
(6,621 |
) |
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE |
$ |
(0.23 |
) |
$ |
(0.31 |
) |
|
$ |
(0.72 |
) |
$ |
(0.73 |
) |
|
|
|
|
|
|
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - |
|
|
|
|
|
BASIC AND DILUTED |
|
25,068,334 |
|
|
9,111,694 |
|
|
|
22,334,311 |
|
|
9,111,039 |
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
financial statements. |
Genelux (NASDAQ:GNLX)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Genelux (NASDAQ:GNLX)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024