Calidi Biotherapeutics Receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded Viral Therapy for the Treatment of Patients with Soft Tissue Sarcoma
FDA Fast Track Designation: Calidi Biotherapeutics has received Fast Track designation from the FDA for its oncolytic virus therapy, CLD-201, aimed at treating soft tissue sarcoma, which will expedite its development and review process.
Clinical Development Plans: The company plans to conduct a Phase 1 trial to assess the safety and efficacy of CLD-201 in various advanced solid tumors, including sarcoma and triple-negative breast cancer, leveraging its proprietary Redtail platform technology.
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Calidi Biotherapeutics Announces Financial Results and Key Operational Updates for Q3 2025
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.
Calidi Biotherapeutics Completes $6.9 Million Public Offering with Full Over-Allotment Option Exercised by Underwriters
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.
Nasdaq Declines 1%; Lowe's Reports Positive Earnings
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.
Dow Rises by 100 Points; Target Stock Declines Following Q2 Earnings Report
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%.
Calidi Biotherapeutics Reveals Pricing for $6 Million Underwritten Public Offering
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.
Calidi Loss Down 23 Percent in Fiscal Q2
Financial Performance: Calidi Biotherapeutics reported a GAAP earnings per share of $(1.99) for Q2 2025, missing analyst estimates by $0.07, with a net loss of $5.7 million, an improvement from $7.4 million in the previous year, but cash reserves decreased significantly to $5.3 million.
Product Development and Strategy: The company is advancing its cancer therapy platforms, particularly the RedTail enveloped virus system and allogeneic stem cell-based immunotherapy, while facing ongoing funding challenges and aiming for key regulatory milestones, including an IND filing for CLD-401 by the end of 2026.
Calidi Biotherapeutics Announces Financial Results and Key Operational Updates for Q3 2025
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.
Calidi Biotherapeutics Completes $6.9 Million Public Offering with Full Over-Allotment Option Exercised by Underwriters
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.
Nasdaq Declines 1%; Lowe's Reports Positive Earnings
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.
Dow Rises by 100 Points; Target Stock Declines Following Q2 Earnings Report
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%.
Calidi Biotherapeutics Reveals Pricing for $6 Million Underwritten Public Offering
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.
Calidi Loss Down 23 Percent in Fiscal Q2
Financial Performance: Calidi Biotherapeutics reported a GAAP earnings per share of $(1.99) for Q2 2025, missing analyst estimates by $0.07, with a net loss of $5.7 million, an improvement from $7.4 million in the previous year, but cash reserves decreased significantly to $5.3 million.
Product Development and Strategy: The company is advancing its cancer therapy platforms, particularly the RedTail enveloped virus system and allogeneic stem cell-based immunotherapy, while facing ongoing funding challenges and aiming for key regulatory milestones, including an IND filing for CLD-401 by the end of 2026.
