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Genelux Corporation Reports Second Quarter Financial Results and Provides Business Updates

On August 13, 2026 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported financial results for the second quarter of 2026 and provided general business updates.

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"During the second quarter, the Company continued to make meaningful clinical and operational progress. We look forward to reporting the upcoming topline data of our Phase 3 OnPrime/GOG-3076 registrational trial, as well as dose-finding updates from our systemic administration studies in lung cancer," said Thomas Zindrick, President, CEO and Chairman of Genelux. "Recent translational findings further support Olvi-Vec’s tumor-priming immunotherapy mechanism and its potential to promote tumor sensitization to platinum-based chemotherapy, as well as strengthening the scientific foundation of our ongoing clinical development programs."

"Alongside our clinical progress, we continue advancing our manufacturing and operational capabilities in preparation for the next stage of Olvi-Vec’s development. As our registration-directed programs mature, we remain focused on strengthening our organization, investing in our capabilities, and preparing for potential commercialization and future pipeline expansion," concluded Mr. Zindrick.

Clinical Program Highlights

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer:
Genelux continues to advance Olvi-Vec toward potential registration for platinum-resistant/refractory ovarian cancer (PRROC), a setting defined by limited treatment options. Ovarian cancer is the 5th leading cause of cancer-related death among women, and more than 70% of patients diagnosed with ovarian cancer in the United States will not respond to or will relapse after frontline platinum-based therapy (NIH Ovarian Cancer Fact Sheet 2022), underscoring the significant unmet medical need Olvi-Vec seeks to address.

Olvi-Vec’s intraperitoneal administration is designed to deliver high, localized dosing within the peritoneal cavity to drive anti-tumor activity and resensitize tumors to platinum-based chemotherapy.

OnPrime/GOG-3076 (NCT05281471) is an ongoing multi-center, randomized, open-label Phase 3 registrational trial being conducted at sites across the United States, with topline data anticipated in the second half of 2026.
The trial is evaluating Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab against an active comparator arm of physician’s choice of chemotherapy and bevacizumab in women with PRROC (including fallopian tube and primary peritoneal cancers).
In June 2026, Genelux announced the publication of translational analyses from the Phase 1b/2 VIRO-15 trial demonstrating immune activation, remodeling of tumor microenvironment, and gene expression changes consistent with platinum sensitization following treatment with Olvi-Vec. These data were presented in Gynecologic Oncology Reports, a peer-reviewed journal published by Elsevier, available here.

Olvi-Vec in Lung Cancer:
Genelux continues to advance two ongoing systemic Olvi-Vec lung cancer trials, expanding the platform beyond intraperitoneal delivery into a broader range of solid tumor types. Together, data from dose-escalation cohorts in these studies are designed to generate the clinical evidence to guide selection of a recommended systemic dose for subsequent development in lung cancer and for future development in additional systemic indications.

The Phase 1b/2 study (OLVI-VEC-SCLC-202) in small-cell lung cancer (SCLC) (NCT07136285) is evaluating Olvi-Vec in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-resistant or relapsed disease after failing previous treatment, including frontline platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China.
The Phase 2 VIRO-25 study (NCT06463665) is assessing Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States and is designed to extend Olvi-Vec’s tumor-priming approach into NSCLC.

Additional dose‑finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO‑25 trials are expected in 2026, aligning with the Company’s strategy to optimize a systemic dosing regimen and inform future registrational development.

Second Quarter 2026 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $18.7 million as of June 30, 2026. The Company expects that combined cash, cash equivalents, marketable securities and restricted cash will fund operations into the first quarter of 2027.

Research and development (R&D) expenses were $6.5 million and $4.8 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $1.8 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime/GOG-3076 registration trial.

General and administrative (G&A) expenses were $3.1 million and $3.0 million for the three months ended June 30, 2026 and 2025, respectively, an increase of $0.1 million. The increase was primarily driven by an increase in stock compensation, partially offset by a reduction in professional services and other expenses.

Net loss was $9.5 million or $0.21 per share for the three months ended June 30, 2026, as compared to $7.5 million or $0.20 per share over the same period in 2025.

(Press release, Genelux, AUG 13, 2026, View Source [SID1234670093])

Calidi Biotherapeutics Reports Second Quarter 2026 Financial Results and Recent Business Highlights

On August 13, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported financial and operating results for the three months ended June 30, 2026, and reviewed recent business highlights.

"Throughout the second quarter, Calidi continued to advance its RedTail platform and redefine the potential of oncolytic viruses and genetic medicine," said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. "We anticipate CLD-401, the lead drug candidate from our RedTail platform, entering the clinic during the first quarter of 2027. In addition, we have expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."

Second Quarter 2026 and Recent Business Developments

In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs, and the FDA provided feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds upon the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.
Presented preclinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on CLD-501, the lead compound from Calidi’s in situ TCE approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 superagonist (IL-15 SA). The Company also presented preclinical data on CLD-401, its lead program. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 SA, a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment, including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models.
Strengthened its Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders served as strategic advisor to Celgene’s Chief Medical Officer following Celgene’s acquisition of Juno, where she was Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb following its acquisition of Celgene. Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including Senior Vice President, Global Head of Clinical Operations and Industry Collaboration.
Reduced general and administrative expenses by $1.5 million, or 48%, in the second quarter of 2026 compared with the same period in 2025. The Company will continue its tight focus on expense management to ensure sufficient capital to advance its pipeline.
Second Quarter 2026 Financial Results

Calidi reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, for the second quarter of 2026, compared with a net loss attributable to common stockholders of $5.7 million, or $31.75 per share, for the same period in 2025. Prior-period share and per-share amounts have been adjusted to reflect the Company’s 1-for-16 reverse stock split completed in July 2026.

Research and development expenses were $2.6 million for the second quarter of 2026, unchanged from the second quarter of 2025.

General and administrative expenses were $1.6 million for the second quarter of 2026, compared with $3.1 million for the comparable period in 2025.

The Company had $4.1 million in cash and $0.2 million in restricted cash as of June 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.

(Press release, Calidi Biotherapeutics, AUG 13, 2026, View Source [SID1234670092])

Zentalis Pharmaceuticals Announces Pricing of Underwritten Public Offering

On August 13, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) ("Zentalis" or the "Company"), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported the pricing of an underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $3.50 per share. The total gross proceeds to the Company from the offering are expected to be approximately $80.5 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company. All of the common stock is being offered by the Company. The offering is expected to close on August 17, 2026, subject to customary closing conditions. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 3,450,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The Company intends to use the net proceeds from the offering, together with the Company’s existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company’s companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities and Oppenheimer & Co. are acting as joint bookrunners for the offering. H.C. Wainwright & Co. is acting as a passive bookrunner for the offering. Rodman & Renshaw LLC is acting as a manager for the offering.

The securities described above are being offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2025, and became effective on April 4, 2025. This offering is being made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A final prospectus supplement related to the offering (including the accompanying prospectus) will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement related to the offering and the accompanying prospectus may be obtained, when available, by visiting the SEC’s website or by contacting: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

(Press release, Zentalis Pharmaceuticals, AUG 13, 2026, View Source [SID1234670091])

bioAffinity Technologies Announces Pricing of $4M Private Placement Offering Priced At-the-Market Under Nasdaq Rules

On August 13, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported that it has entered into a securities purchase agreement with an institutional investor to sell 8,462,027 shares of common stock (or pre-funded warrants in lieu thereof), together with two warrants to purchase up to an aggregate 16,924,054 shares of common stock, in a private placement offering priced at-the-market under Nasdaq rules. The combined effective offering price for each share of common stock (or pre-funded warrant) and accompanying two warrants to be issued is $0.4727. The combined effective offering price for each pre-funded warrant and accompanying two warrants to be issued is $0.4657. The pre-funded warrants will have an exercise price of $0.007 per share of common stock and the warrants will have an exercise price of $0.4727 per share, will be exercisable following stockholder approval, and will expire five years from the date of issuance.

The gross proceeds to the Company from the offering are estimated to be approximately $4.0 million before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about August 14, 2026, subject to the satisfaction of customary closing conditions.

WallachBeth Capital LLC is acting as the sole placement agent in connection with the offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company will provide customary registration rights for the shares of common stock underlying the warrants, subject to the terms of the definitive transaction documents.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, BioAffinity Technologies, AUG 13, 2026, View Source [SID1234670090])

Artera Enrolls First Patient in DIRECT-AI Registry, Marking Milestone in Real-World Evidence Generation for AI-Powered Prostate Cancer Care

On August 13, 2026 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the enrollment of the first patient in its DIRECT-AI registry study, marking the beginning of real-world prospective evidence generation for the first nationwide registry evaluating the clinical utility of an AI-powered prostate cancer test. The first patient was enrolled at The Urology Place, a leading independent urology practice in San Antonio, TX, recognized for its commitment to advancing innovation in prostate cancer care.

Building on extensive clinical validation of the ArteraAI Prostate Test, the enrollment of the first patient marks the next phase in evaluating how the test influences treatment discussions, shared decision-making, and long-term outcomes for patients with localized prostate cancer.

The non-interventional observational registry follows patients receiving the ArteraAI Prostate Test as part of their standard care, without requiring additional procedures. Data collected from participating clinical sites across the United States will provide insights into how AI-powered prognostic and predictive information is used in clinical decision-making, including the impact of results on shifts in treatment choices and physician confidence.

"As clinicians, we’re constantly evaluating whether new technologies truly change the way we care for patients or provide meaningful value beyond existing approaches," said Naveen Kella, M.D., Founder and Director of The Urology Place. "DIRECT-AI allows us to better understand how AI-powered insights are incorporated into routine clinical practice and how they support more informed conversations. We’re proud to contribute to generating this evidence, as it is an important step toward advancing more personalized prostate cancer care."

Prostate cancer treatment decisions are highly individualized and can depend on multiple factors, including disease characteristics, patient preferences, age, clinical comorbidities, and the potential benefits and risks of different approaches. As treatment options continue to evolve, generating evidence on how new tools perform in real-world settings is essential to understanding their clinical utility. In addition, real-world evidence from DIRECT-AI may help inform subsequent health economic and cost-effectiveness analyses by providing insights into how AI-guided treatment decisions change patterns of care and healthcare resource utilization.

"Clinical validation demonstrates a test’s performance; clinical utility helps us understand its impact in real-world care," said Calvin Chao, MD, Vice President of Medical Science at Artera. "DIRECT-AI reflects Artera’s commitment to generating evidence that can inform how AI-powered tools are integrated into oncology practice and help shape the future of precision medicine."

(Press release, Artera, AUG 13, 2026, View Source [SID1234670089])