News
Genelux Corporation Reports First Quarter 2024 Financial Results and Provides General Business Update
Genelux Corporation
WESTLAKE VILLAGE, Calif., May 9, 2024 (GLOBE NEWSWIRE) – Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced Q1 2024 financial results and provided general business updates.
“Our pivotal Phase 3 registration trial of Olvi-Vec in platinum-resistant/refractory ovarian cancer continues to enroll patients,” he said. Thomas Zindrick, Chairman, President and CEO of Genelux. “Looking ahead, we are excited about advancing Olvi-Vec into additional cancer indications through intravenous administration, a route of administration preferred by clinicians, and seeking to further validate our hypothesis that Olvi-Vec can reverse the platinum resistance in various tumor types.”
The Company expects to initiate our Phase 2 study in recurrent non-small cell lung cancer in the second quarter of this year and report interim data from our Phase 1b study in recurrent small cell lung cancer later this year. Both trials were designed to administer Olvi-Vec intravenously and to rechallenge patients who previously failed platinum-based chemotherapy. The projects build on an earlier clinical trial showing the benefit of Olvi-Vec administered intravenously in patients with lung disease (primary or metastatic) and our Phase 2 data in platinum-resistant/refractory ovarian cancer (PRROC). ).
Pipeline highlights
We are actively enrolling patients in the ongoing Phase 3 OnPrime/GOG-3076 registrational trial at PRROC in the United States. Currently, 22 sites have been activated to enroll patients with additional sites identified and in various stages of activation (NCT05281471). We are on track to achieve top-line results in the second half of 2025.
Patient recruitment has been increasing in the ongoing Phase 1b portion of the Phase 1b/2 study testing systemic administration of Olvi-Vec in patients with recurrent small cell lung cancer. The trial is co-sponsored with our partner Newsoara BioPharma Co., Ltd. and is being conducted at prominent locations in China. We anticipate the provisional reading in the second half of 2024.
The initiation of the Phase 2 trial in the United States, testing systemic administration of Olvi-Vec in recurrent non-small cell lung cancer trials, is expected to begin in the first half of 2024.
Business Updates
In the first quarter of 2024, we filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission. Pursuant to the shelf registration statement, we may offer and sell, from time to time, up to $300.0 million of common stock, preferred stock, debt securities and/or warrants in one or more offerings. Concurrently with the shelf registration statement, the Company entered into a sales agreement under which the Company may offer to sell shares of common stock up to $100.0 million through Guggenheim Securities, acting as our sales agent.
The story continues
First Quarter 2024 Financial Results
Cash, cash equivalents and short term investments was $19.6 million as of March 31, 2024. We expect our cash, cash equivalents and existing short-term investments to provide inflow in the second quarter of 2025.
Research and development (R&D) expenses were $4.0 million in Q1 2024 compared to $2.8 million in Q1 2023, respectively. The $1.2 million year-over-year increase in R&D expenses in 2024 was primarily due to a $0.4 million increase related to new employee hires after the first quarter of 2023, an increase of $0.3 million in stock compensation and a $0.4 million increase related to clinical manufacturing, regulatory expenses and other R&D expenses.
General and administrative expenses (G&A) were $4.1 million in the first quarter of 2024, compared to $3.8 million in the first quarter of 2023. The $0.3 million year-over-year increase in general and administrative expenses in 2024 was primarily the result of a $0.4 million increase in professional services expenses in 2024, primarily due to costs associated with our shelf registration on Form S-3 and a $0.5 million increase due to consulting expenses , employee-related costs and other general and administrative expenses, offset by a $0.6 million reduction in stock compensation expense in the first quarter of 2024 compared to the first quarter of 2023.
Net loss was $7.9 million in the first quarter of 2024, or a net loss per share of $0.29, compared to a net loss of $10.4 million in the first quarter of 2023, or a net loss per share at $0.53.
About Genelux Corporation
Genelux is an advanced 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, engineered strain of the vaccinia virus. Olvi-Vec is currently being evaluated in OnPrime/GOG-3076, a multicenter, randomized, open-label Phase 3 registration trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum doublet + bevacizumab compared to Physician choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux’s discovery and development efforts revolves around its proprietary CHOICE™ platform, from which the company has developed an extensive library of isolated and engineered immunotherapeutic product candidates for oncolytic vaccinia virus, including Olvi-Vec. For more information please visit www.genelux.com and follow us on Twitter @Genelux_Corp and so 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 in accordance with the provisions of safe harbor 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 “believe,” “anticipate,” “expect,” “may” , “plans” or “will”. Forward-looking statements in this release include, but are not limited to, statements relating to Genelux’s future plans and prospects, Genelux’s anticipated cash flow and sufficiency of its resources to support its planned operations, the planned timing of results of data from Genelux on its ongoing clinical trials and continued development of Olvi-Vec, the planned initiation of the Phase 2 trial in non-small cell lung cancer and its timing; 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 heading “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 they are made and are based on management’s assumptions and estimates as of that date. Genelux undertakes no 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.
Contacts with investors and media
Ankit Bhargava, MD
Alelo Communications, LLC
genelux@allelecomms.com
Source: Genelux Corporation
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Genelux Corporation |
||||||
|
Condensed Balance Sheets |
||||||
|
(in thousands, except for share values and par value data) |
||||||
|
March 31, |
December 31th, |
|||||
|
2024 |
2023 |
|||||
|
ACTIVE |
(Unaudited) |
|||||
|
Current assets |
||||||
|
Cash and cash equivalents |
$ |
4,061 |
$ |
9,418 |
||
|
Short-term investments |
15,566 |
13,773 |
||||
|
Prepaid expenses and other current assets |
1,577 |
1,012 |
||||
|
Total Current Assets |
21,204 |
24,203 |
||||
|
Fixed assets, net |
1,116 |
1,170 |
||||
|
Right-of-use assets |
2,264 |
2,428 |
||||
|
Other assets |
92 |
92 |
||||
|
Total other assets |
3,472 |
3,690 |
||||
|
TOTAL ASSETS |
$ |
24,676 |
$ |
27,893 |
||
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
||||||
|
Current Liabilities |
||||||
|
Accounts payable and accrued expenses |
$ |
5,313 |
$ |
3,784 |
||
|
Accrued Payroll and Payroll Taxes |
1,908 |
2,117 |
||||
|
Lease liabilities, current portion |
584 |
653 |
||||
|
Total Current Liabilities |
7,805 |
6,554 |
||||
|
Lease liabilities, long-term portion |
1,787 |
1,866 |
||||
|
Total responsibilities |
9,592 |
8,420 |
||||
|
Net worth |
||||||
|
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; |
||||||
|
no shares issued and outstanding, respectively; |
– |
– |
||||
|
Common stock, $0.001 par value, 200,000,000 shares authorized; |
||||||
|
26,996,740 and 26,788,986 shares issued and outstanding, respectively |
27 |
27 |
||||
|
Treasury shares, 433,333 shares, at cost |
(433 |
) |
(433 |
) |
||
|
Additional paid-in capital |
244,869 |
241,389 |
||||
|
Accumulated other comprehensive income (loss) |
(5 |
) |
14 |
|||
|
Accumulated deficit |
(229,374 |
) |
(221,524 |
) |
||
|
Total Net Worth |
15,084 |
19,473 |
||||
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
24,676 |
$ |
27,893 |
||
|
The attached notes are an integral part of these condensed financial statements. |
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Genelux Corporation |
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|
Condensed Statements of Operations |
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(in thousands, except share values and per share data) |
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Three months are over |
||||||
|
March 31, |
||||||
|
2024 |
2023 |
|||||
|
(Unaudited) |
||||||
|
Revenues |
$ |
8 |
$ |
170 |
||
|
Operational expenses: |
||||||
|
Research and Development |
4,010 |
2,845 |
||||
|
General and administrative |
4,113 |
3,787 |
||||
|
Total operating expenses |
8,123 |
6,632 |
||||
|
Loss of operations |
(8,115 |
) |
(6,462 |
) |
||
|
Other income (expenses): |
||||||
|
Interest Income |
265 |
– |
||||
|
Interest Expenses |
– |
(143 |
) |
|||
|
Amortization with debt discount |
– |
(649 |
) |
|||
|
Financing costs |
– |
(3,110 |
) |
|||
|
Total other income (expenses), net |
265 |
(3,902 |
) |
|||
|
NET LOSS |
$ |
(7,850 |
) |
$ |
(10,364 |
) |
|
LOSS PER ORDINARY SHARE – BASIC AND DILUTED |
$ |
(0.29 |
) |
$ |
(0.53 |
) |
|
WEIGHTED AVERAGE OF COMMON SHARES IN FORCE – BASIC AND DILUTED |
26,849,737 |
19,575,631 |
||||
|
The attached notes are an integral part of these condensed financial statements. |
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|
Genelux Corporation |
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|
Condensed Comprehensive Loss Statements |
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|
(in thousands) |
||||||
|
Three months are over |
||||||
|
March 31, |
||||||
|
2024 |
2023 |
|||||
|
(Unaudited) |
||||||
|
Net loss |
$ |
(7,850 |
) |
$ |
(10,364 |
) |
|
Other comprehensive losses: |
||||||
|
Net unrealized loss on short-term investments |
(19 |
) |
– |
|||
|
Comprehensive loss |
$ |
(7,869 |
) |
$ |
(10,364 |
) |
|
The attached notes are an integral part of these condensed financial statements. |
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The spotlight next week will shift somewhat to the Federal Reserve’s second-quarter earnings season and monetary policy. Market watchers will be treated to results from several major names, including Dow 30 components Goldman Sachs (GS), UnitedHealth (UNH), Johnson & Johnson (JNJ) and American Express (AXP), along with streaming giant Netflix (NFLX).
The Fed will still attract some attention as investors will be eager to hear from a packed lineup of central bank speakers just before the policy meeting lockout period.
In terms of the economic calendar, after fifteen days of labor market and inflation indicators, activity data will gain momentum in the form of the latest retail sales and industrial production reports.
Earnings Highlight: Monday, July 15 – Goldman Sachs (GS) and BlackRock (Black). See the full earnings calendar.
Earnings Highlight: Tuesday, July 16 – UnitedHealth (UNH), Bank of America (BAC), Progressive (PGR), Morgan Stanley (IN), PNC Financial (PNC) and JB Hunt Transport (JBHT). See the full earnings calendar.
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Earnings Highlight: Thursday, July 18 – Netflix (NFLX), Abbott Laboratories (ABT), Black stone (BX), Domino’s pizza (ZDP) and Taiwan Semiconductor Manufacturing (TSM). See the full earnings calendar.
Earnings Highlight: Friday, July 19 – American Express (AXP), Halliburton (THANKS) and Travelers (VRT (return to recoverable value)) See the full earnings calendar.
IPO Observation: Hospital and healthcare clinic operator Ardent Health Partners (TARDT), insurance service provider Twfg (TWFG) and the biotechnology company Lirum Therapeutics (LRTX) are expected to price their IPOs and begin trading next week. The analyst quiet period ends at Rectitude (RECT) to free up analysts to publish ratings.
Police cars outside the residence of Thomas Matthew Crooks, the suspected shooter at a Trump rally on Saturday, investigate the area in Pennsylvania. Following the incident, one rally attendee was killed, two rally attendees are in critical condition and Donald Trump suffered a non-fatal gunshot wound. The shooter is dead after being shot dead by the United States Secret Service. (Photo by Kyle Mazza/Anadolu via Getty Images)
Investors will initially favor traditional safe-haven assets and may lean toward trades more closely tied to former President Donald Trump’s chances of winning the White House after he survived an assassination attempt, according to market watchers.
“There will undoubtedly be some protectionist or safe-haven flows into Asia early this morning,” said Nick Twidale, chief market analyst at ATFX Global Markets. “I suspect gold could test all-time highs, we’ll see the yen being bought and the dollar, and flows into Treasuries as well.”
Early market commentary suggested Trump’s shooting at a rally in Pennsylvania on Saturday could also prompt traders to increase his likelihood of success in the November election. His support for looser fiscal policy and higher tariffs is generally seen as likely to benefit the dollar and weaken Treasuries.
An indicator of market sentiment heading into the weekend: Bitcoin surged above $60,000, likely reflecting Trump’s pro-crypto stance.
Other assets positively linked to the so-called Trump trade include stocks of energy companies, private prisons, credit card companies and health insurers.
Traders will also be closely watching market measures of expected volatility on Monday, such as those in the tariff-sensitive Chinese yuan and Mexican peso, which have begun to price in the U.S. vote.
Trump said he was shot in the right ear after a shooting at his rally. His campaign said in a statement that he was “fine” after the incident, which prompted him to rush off the stage.
“Currencies will be the first major market on Monday in Asia to react to the weekend’s shots. There’s potential for extra volatility, and getting a clear reading could be especially difficult because liquidity will be hurt by Japan’s national holiday,” said Garfield Reynolds, Asia team leader for Bloomberg Markets Live.
Strategists had already expected a volatile run-up to the election, particularly as Democrats are still agonizing over President Joe Biden’s candidacy after his poor performance in last month’s debate raised questions about his age. Investors were also grappling with the possibility that the election could end in a drawn-out dispute or political violence.
But there is little precedent for events like those in Pennsylvania. When President Ronald Reagan was shot four decades ago, the stock market plunged before closing early. The next day, March 31, 1981, the S&P 500 rose more than 1% and benchmark 10-year Treasury yields fell 9 basis points to 13.13%, according to data compiled by Bloomberg.
Bond investors should pay particular attention as the attack is likely to boost Trump’s election chances and ultimately lead to concerns about the fiscal outlook, according to Marko Papic, chief strategist at California-based BCA Research Inc.
“The bond market must at some point become aware of President Trump’s greater chances of winning the White House than any of his rivals,” Papic wrote. “And I continue to believe that as his chances increase, so too must the likelihood of a bond market revolt.”
Kyle Rodda, senior financial markets analyst at Capital.com, said he was seeing client flows into Bitcoin and gold following the shooting.
“This news marks a turning point in American policy norms,” he said. “For markets, it means safe-haven trades, but more tilted toward non-traditional safe-havens.”
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Jio Financial share price: Should you buy this Reliance group stock on Monday ahead of Q1 FY2024 results?
Q1 2024 Results: Jio Financial Share Price will be in focus on Monday as the Reliance Group company has a fixed board meeting on July 15, 2024 to consider and approve the company’s unaudited standalone and consolidated financial results. Trust Group company informed about the Q1 2024 Results date on Wednesday last week via an exchange filing. According to stock market experts, Jio Financial Services Limited is poised to deliver impressive Q1 results for FY25 on solid operating income. They have forecast a healthy QoQ PAT for the company in Q1 FY25.
Jio Financial Services News
Speaking on the Jio Financial Services Q1 2024 results, Manish Chowdhury, Head of Research, StoxBox, said, “We believe Jio Financial Services is poised to deliver impressive results in Q1FY25 aided by its operating income, which is likely to show robust growth driven by strong investment income, which in turn should lead to healthy PAT growth on a sequential basis. Jio Financial Services continues to make strategic moves such as launching digital products and expanding its ecosystem, with a clear focus on future growth. The company has announced plans to introduce products for lending against stocks and mutual funds, leveraging Jio’s large user base, which could be a significant growth driver in the coming quarters.”
“Furthermore, with the NBFC receiving RBI approval to become a primary investment company, Jio Financial Services is well-positioned to unlock value from its investments. Overall, we expect the company to report robust numbers in the upcoming quarter,” the StoxBox expert added.
Jio Financial Stock Target Price
Speaking about the technical outlook of Jio Financial share price, Ganesh Dongre, Senior Manager, Technical Research at Anand Rathi, said, “Jio Financial Services share price is poised to make a fresh high at the ₹260 apiece level. If the stock breaks above this mark, the Reliance Group stock could make a fresh high by touching the ₹290-₹295 zone. Hence, those with Jio Finance stock in their portfolio are advised to stick to the script by keeping a stop loss at ₹205. If the stock breaks above ₹260 decisively, then one can upgrade the stop loss at ₹240 for the near-term target of ₹295.”
On the advice to new buyers regarding Jio Financial stock, Ganesh Dongre said, “New buyers are advised to wait for the breakout. Once the stock breaks above ₹260, one can buy this Reliance Group stock at the short term target of ₹295, keeping a stop loss of ₹240 apiece.”
Disclaimer: The views and recommendations made above are those of individual analysts or brokerage firms, and not of Mint. Investors are advised to consult with certified experts before making any investment decisions.
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