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.

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"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])

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.

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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])

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.

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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])

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.

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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])

On August 13, 2026 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a strategic collaboration with Merck, known as MSD outside the United States and Canada, to utilize SCRI’s Accelero delivery model designed to expand patient access to oncology clinical trials at community-based sites across the U.S.

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The oncology clinical research landscape is rapidly evolving, as study designs become more complex, patient eligibility criteria more precise, and the heightened urgency to bring breakthrough science to patients faster continues to grow. These dynamics require modern clinical trial delivery models that are more efficient, data-enabled, and accessible for patients in community settings. SCRI and Merck are working together to address the challenges by advancing a scalable approach to oncology trial execution.

"At Merck, we are focused on advancing research to better understand cancer and potential therapeutic approaches. By leveraging the Accelero delivery model, we have the potential to reach patients faster, reduce protocol complexity, and make oncology clinical studies more accessible in the communities where patients live," said Jennifer Coppola, Associate Vice President and Regional Head for Global Clinical Trial Operations of North America at Merck Research Laboratories.

Through Accelero, SCRI uses a streamlined operating model to improve the speed and efficiency of oncology drug development. SCRI works closely with its physician network and industry partners to identify specific challenges and tailor fit-for-purpose solutions, including EHR-to-EDC data transfer across portfolios, accelerated site start-up and increased enrollment on high-priority studies. With select industry partners, Accelero has delivered site activations up to 50 percent faster than traditional operations, enrollment rates 19 percent higher than the 7 percent national average, and 95 percent fewer data changes than traditional clinical research coordinator data entry processes.1

"Merck has helped shape the modern era of cancer treatment, and we share a commitment to advance the next generation of cancer medicines through innovative approaches," said Dee Anna Smith, Chief Executive Officer of SCRI. "Together, we are committed to accelerating trial delivery, reduce operational friction, and bring research to patients."

(Press release, Sarah Cannon Research Institute, AUG 13, 2026, View Source [SID1234670088])