Calidi Biotherapeutics Presents Novel BiTE Approach at AACR Conference
Calidi Biotherapeutics presented data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology, AACR-IO, conference being held in Los Angeles, California. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist, a known T-cell activator, in the TME. In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations of BiTEs in solid tumors.
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- Platform Showcase: At the AACR Immuno-Oncology conference, Calidi presented data on its RedTail platform, which enables systemic delivery of biologics that can express IL-15 superagonist in the tumor microenvironment, significantly enhancing T-cell activation and offering new hope for solid tumor treatments.
- Breakthrough with BiTEs: Utilizing the RedTail platform, Calidi successfully demonstrated viruses that express both functional BiTEs and IL-15 SA, a novel approach that may overcome historical limitations of BiTEs in solid tumors by enhancing T-cell activity within the tumor microenvironment.
- Clinical Development Progress: Calidi is conducting IND-enabling studies for CLD-401, with plans to submit an IND application by the end of 2026, marking a significant advancement in targeting high unmet medical needs in non-small cell lung cancer and head and neck cancer.
- Strategic Partnership Opportunities: Calidi is actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform, demonstrating the company's foresight and competitive edge in the biotechnology sector.

New Data Presentation: Calidi Biotherapeutics presented promising preclinical data on CLD-401 at the SITC annual meeting, showing its ability to evade immune clearance and effectively deliver genetic medicines to metastatic tumor sites.
Scientific Advisory Board Established: The company formed a new Scientific Advisory Board comprising esteemed experts to support the development of CLD-401 and enhance the capabilities of its RedTail platform for targeted genetic medicine delivery.
Financial Update: Calidi raised $6.9 million through a public offering, increasing total gross proceeds for 2025 to $23 million, while reporting a net loss of $5.2 million for Q3 2025, slightly higher than the previous year.
Platform Expansion: The RedTail platform's functionality is being expanded with new payloads and programmable membrane targeting, advancing its applications in virotherapy beyond oncology.

Public Offering Announcement: Calidi Biotherapeutics has successfully closed an underwritten public offering, raising $6.9 million in gross proceeds, including the full exercise of the underwriters' over-allotment option.
Details of Securities Sold: The offering included 1,922,764 common stock units and 1,528,000 pre-funded warrant units, with prices set at $2.00 per Common Stock Unit and $1.999 per Pre-Funded Unit.
Company Overview: Calidi Biotherapeutics is focused on developing targeted therapies for cancer treatment, utilizing its proprietary Redtail platform to deliver genetic medicines to metastatic sites.
Forward-Looking Statements: The press release contains forward-looking statements regarding the company's future developments and potential risks associated with clinical trials and capital raising efforts.
U.S. Stock Market Performance: U.S. stocks declined mid-session, with the Nasdaq Composite dropping over 200 points and the S&P 500 and Dow also experiencing losses.
Lowe's Earnings Report: Lowe's Companies reported better-than-expected second-quarter earnings, with adjusted EPS rising to $4.33 and quarterly sales reaching $23.96 billion, prompting an update in fiscal guidance.
Equities Movement: NovaBay Pharmaceuticals saw a significant stock increase of 68% after a securities purchase agreement, while enVVeno Medical Corporation shares plummeted 72% following FDA news.
Global Market Trends: European shares showed mixed results, Asian markets closed mixed with Japan's Nikkei falling, and U.S. mortgage applications decreased by 1.4% from the previous week.
U.S. Stock Market Performance: U.S. stocks showed mixed results with the Dow Jones gaining over 100 points, while NASDAQ and S&P 500 experienced declines.
Target Corporation Earnings Report: Target's shares fell about 9% despite reporting adjusted earnings per share of $2.05, beating estimates, but sales declined year-over-year.
Notable Stock Movements: NovaBay Pharmaceuticals saw a significant increase of 104% after a securities purchase agreement, while enVVeno Medical Corp dropped 70% due to FDA non-approval.
Global Market Trends: European and Asian markets closed mixed, with varying performances across major indices, and U.S. mortgage applications decreased by 1.4%.

Public Offering Announcement: Calidi Biotherapeutics has announced a public offering priced at $6 million, consisting of common stock and pre-funded warrant units, despite challenging market conditions.
Details of the Offering: The offering includes 1,472,764 common stock units priced at $2.00 each and 1,528,000 pre-funded warrant units priced at $1.999 each, with warrants exercisable for five years.
Underwriters and Closing Date: Ladenburg Thalmann & Co. Inc. is the sole book-running manager, and the offering is expected to close on August 21, 2025, pending customary closing conditions.
Company Overview: Calidi Biotherapeutics focuses on developing targeted therapies using its proprietary Redtail platform for treating cancers such as non-small cell lung cancer and ovarian cancer.





