Vtv Therapeutics Stock Price, News & Analysis

vTv Therapeutics (VTVT) announced that the FDA has lifted the clinical hold on its cadisegliatin program, including the CATT1 Phase 3 trial for type 1 diabetes (T1D). The company plans to amend the protocol to reduce the trial duration from 12 to 6 months, expediting the path to larger pivotal studies needed for NDA submission.

Cadisegliatin, an oral liver-selective glucokinase activator, aims to be the first oral adjunctive therapy to insulin for T1D. The drug has shown good tolerability in over 500 subjects with up to six months of treatment. The primary endpoint of measuring level 2 and 3 hypoglycemia rates at 6 months remains unchanged.

The clinical hold, initially placed on July 26, 2024, was due to an unresolved chromatographic signal in a human ADME study. The hold was lifted on March 14, 2025, after vTv demonstrated the signal was an experimental artifact. No patients had been dosed in the CATT1 trial during the hold period, and previous studies showed no concerning safety issues.

Cantex Pharmaceuticals has received FDA Orphan Drug Designation for azeliragon to treat brain metastasis from breast cancer. This is the third such designation for azeliragon, following previous designations for pancreatic cancer and glioblastoma in mid-2024 and early 2023.

Azeliragon is an oral, once-daily compound that inhibits the RAGE receptor. The drug's interaction with RAGE on cancer cells has been linked to radiation resistance, disease progression, and metastasis development in breast cancer. This designation provides Cantex with seven years of marketing exclusivity upon product launch, along with development assistance, tax credits, and FDA fee exemptions.

vTv Therapeutics (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on novel small molecules and diabetes treatments, has announced its participation in the 7th Annual Evercore HealthCONx Conference in Coral Gables, Florida. The company's management will engage in a fireside chat and one-on-one meetings during the event, scheduled for December 3-5, 2024.

The presentation is set for December 4, 2024, from 7:55 to 8:15 AM ET. Interested parties can access a live webcast through the Events section of vTv's investor relations website. Meeting requests can be made through institutional contacts.

vTv Therapeutics (Nasdaq: VTVT) announced its 2024 third quarter financial results and provided a corporate update. The company reported a cash position of $41.6 million as of September 30, 2024, up from $9.4 million at the end of 2023, largely due to private placement financing and ATM Offering proceeds. R&D expenses rose to $3.2 million from $2.8 million due to higher indirect costs, offset by lower spending on cadisegliatin. G&A expenses increased to $3.3 million from $2.5 million, driven by higher share-based, legal, and payroll costs. The net loss attributable to shareholders was $4.8 million or $0.88 per share, down from $6.7 million or $3.19 per share a year ago. The company’s lead program, cadisegliatin, is under FDA clinical hold, but discussions are ongoing. Total assets were $43.2 million, and total liabilities were $25.3 million as of September 30, 2024.

vTv Therapeutics (Nasdaq: VTVT) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

• Screened first patient in cadisegliatin pivotal trial for type 1 diabetes (T1D), currently on clinical hold
• Expanded Newsoara Biopharma license agreement for PDE4 inhibitor HPP737 to a global license for $20 million upfront
• Azeliragon received Orphan Drug Designation for pancreatic cancer
• Q2 2024 financial results: Cash position of $45.5 million, R&D expenses of $3.4 million, G&A expenses of $3.7 million
• Net loss of $5.2 million or $0.81 per basic share

The company is working to resolve the clinical hold on cadisegliatin and resume the study as quickly as possible.

vTv Therapeutics Inc. (Nasdaq: VTVT) announced that the FDA has placed a clinical hold on its cadisegliatin program for type 1 diabetes, including the ongoing CATT1 Phase 3 trial. The hold is due to an unresolved chromatographic signal discovered in a recent human ADME study. The FDA requires an in vitro study to characterize this signal before the program can resume.

Key points:

• No patients had been dosed in CATT1 at the time of the hold
• Past clinical studies showed no concerning safety issues
• Cadisegliatin has been well-tolerated in over 500 subjects for up to six months
• The company is working to resolve the hold and resume enrollment quickly

vTv Therapeutics has initiated the first patient screening for its CATT1 pivotal trial, evaluating cadisegliatin as an adjunct treatment for type 1 diabetes (T1D). Cadisegliatin is a first-in-class oral liver-selective glucokinase activator, designed to regulate blood glucose levels by selectively activating liver glucose pathways. The FDA has granted it Breakthrough Therapy designation for T1D.

The trial will enroll approximately 150 patients across 20 U.S. sites. Cadisegliatin will be tested against a placebo in patients using insulin injections and continuous glucose monitors. The primary endpoint is to compare the incidence of Level 2 or Level 3 hypoglycemic events. Future Phase 2 trials for type 2 diabetes (T2D) are planned in the Middle East.

Cantex Pharmaceuticals announced that four abstracts featuring azeliragon, a RAGE inhibitor, will be presented at the 2024 ASCO Annual Meeting in Chicago. Azeliragon, a once-a-day pill, is being investigated for its potential in treating various difficult-to-treat cancers. The abstracts cover studies on azeliragon's safety and therapeutic effects in metastatic pancreatic cancer, its use in combination with temozolomide and radiotherapy for newly diagnosed glioblastoma, its role in reducing cardiotoxicity in women with early breast cancer, and its effectiveness when combined with stereotactic radiation therapy in patients with brain metastases. The meeting provides a platform for showcasing clinical progress to leading oncology researchers globally.

Cantex Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to its drug azeliragon for treating pancreatic cancer. This designation follows a similar status received for treating glioblastoma in 2023. The designation offers benefits like seven years of marketing exclusivity, tax credits, and fee exemptions. Cantex is conducting a clinical trial to study azeliragon's efficacy on metastatic pancreatic cancer patients in top U.S. cancer centers. CEO Stephen G. Marcus emphasized the urgent need for new treatments for advanced pancreatic cancer and other cancers, enhancing their commitment to innovative therapies.