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vTv Therapeutics Inc. (Nasdaq: VTVT) is a clinical-stage biopharmaceutical company committed to discovering and developing orally administered treatments for metabolic and inflammatory diseases. The company aims to address unmet medical needs through its innovative technology that modulates human proteins into effective medicines. vTv Therapeutics' diverse pipeline includes small molecule clinical and pre-clinical drug candidates targeting a range of conditions such as central nervous system disorders, diabetes, metabolic disorders, inflammation, and cancer.
Leading vTv Therapeutics' pipeline is cadisegliatin (TTP399), an investigational liver-selective glucokinase activator being developed as an adjunctive therapy to insulin for type 1 diabetes (T1D). Cadisegliatin is currently in preparation for Phase 3 clinical trials, with the first study expected to commence in mid-2024. In addition, vTv is exploring further indications for cadisegliatin in type 2 diabetes and other chronic conditions in collaboration with G42 Healthcare Research Technology Projects LLC and IROS, a UAE-based health technology group.
The company has achieved several milestones, including a strategic partnership with Reneo Pharmaceuticals for its PPARδ agonist program. This collaboration includes the potential for significant milestone payments and commercial royalties contingent on the success of Reneo's lead program, mavodelpar.
Apart from its focus on diabetes, vTv Therapeutics is also advancing other promising candidates. These include:
- TTP273: A treatment aimed at metabolic diseases.
- HPP737 and HPP593: Targeting inflammatory disorders.
- Azeliragon: Licensed to Cantex Pharmaceuticals for further development in treating glioblastoma and pancreatic cancer.
vTv Therapeutics continues to build strong financial support, backed by proceeds from strategic sales and investments. Recently, the company secured funds through a private investment in public equity (PIPE) deal to support the upcoming Phase 3 trial of cadisegliatin.
Overall, vTv Therapeutics Inc. is positioned at the forefront of innovative treatments, leveraging its small molecule drug candidates to potentially transform the management of chronic diseases and improve patient outcomes.
Cantex Pharmaceuticals, in collaboration with Michigan Medicine, has launched a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of azeliragon for patients hospitalized with COVID-19. This phase 2/3 trial aims to reduce acute kidney injury risks associated with severe COVID-19, leveraging azeliragon's mechanism of blocking the harmful effects of elevated suPAR levels.
Past research has shown suPAR's involvement in severe COVID-19 outcomes. Notably, azeliragon, previously tested for Alzheimer's, exhibited favorable safety profiles in over 2,000 patients. With ongoing trials, Cantex seeks to expand azeliragon's indications beyond cancer treatments to include severe COVID-19 and related kidney complications. This strategic move could potentially enhance the therapeutic landscape for critical COVID-19 conditions.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced key developments, including the initiation of Phase 3 clinical trials for TTP399, an adjunctive treatment for Type 1 diabetes, expected to start in the second half of 2023. The company appointed Steven Tuch as Chief Financial Officer and Elizabeth Keiley as General Counsel, enhancing its executive team. vTv reported a net loss of $4.7 million or $0.06 per share for Q4 2022, a significant reduction from $7.1 million or $0.11 per share in Q4 2021. The total cash position as of December 31, 2022, was $12.1 million, down from $13.4 million in 2021.
Cantex Pharmaceuticals has received FDA approval to proceed with a clinical trial assessing azeliragon combined with stereotactic radiosurgery for treating brain metastases. This trial, initiated by Miami Cancer Institute, aims to evaluate both safety and effectiveness in patients suffering from this severe condition. Azeliragon, an orally administered small molecule, targets RAGE receptors involved in cancer resistance to radiation. The trial could potentially enhance radiation therapy efficacy and reduce the need for corticosteroids, offering new hope for patients. Cantex is expanding azeliragon's cancer treatment applications, previously granted Orphan Drug Designation for glioblastoma.
Cantex Pharmaceuticals has announced FDA approval to proceed with a Phase 2 clinical trial for azeliragon, targeting newly diagnosed unmethylated glioblastoma patients. This oral medication, taken once daily, has also received Orphan Drug Designation. Glioblastoma, the most common primary brain cancer, presents a serious prognosis, with a median survival of only 15-18 months. Azeliragon aims to inhibit critical interactions in the glioblastoma microenvironment, offering hope for improved outcomes. Additionally, Cantex is exploring azeliragon’s application in other cancers, highlighting its potential versatility. Significant advancements are expected in clinical trials during 2023 and 2024.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced the appointment of Elizabeth (Betzy) Keiley as Executive Vice President and General Counsel. Keiley brings extensive life sciences legal experience from her previous roles, including General Counsel at Entasis Therapeutics and Senior VP at Oxford Immunotec. Her addition is expected to aid vTv in achieving long-term capital funding goals and launching phase 3 clinical trials for TTP399, a treatment for type 1 diabetes. The company is approaching a pivotal point that could lead to significant commercial opportunities in the future.
Cantex Pharmaceuticals announced that the FDA has granted Orphan Drug Designation for its drug azeliragon, aimed at treating glioblastoma, a highly aggressive brain tumor. This once-daily pill inhibits harmful interactions in the glioblastoma microenvironment. Clinical trials involving over 2000 individuals indicate that azeliragon is well tolerated. The Orphan Drug status provides Cantex with seven years of market exclusivity, tax credits, and other development advantages, highlighting the urgent need for new glioblastoma treatments.
vTv Therapeutics has appointed Steven Tuch as its new Chief Financial Officer, effective immediately. Tuch brings over 20 years of experience in financial planning and business development within the life sciences sector, previously leading Rallybio Corporation through a $92.7 million IPO. He will oversee the company's financial strategies as vTv prepares for Phase 3 trials of its lead candidate, TTP399, which has received breakthrough therapy designation. This appointment aims to enhance vTv's capital-raising efforts and support the advancement of innovative treatments for type 1 diabetes.
vTv Therapeutics Inc. (Nasdaq: VTVT) reported its Q3 2022 financial results with a net loss of $4.3 million, or $0.05 per share, compared to a loss of $1.1 million in Q3 2021. The company is set to begin Phase 3 clinical trials for TTP399 in Q1 2023, with agreements in place with CinRx Pharma for $10 million in funding. Cash on hand was $15.3 million as of September 30, 2022. Research and development expenses increased to $3.1 million, primarily due to costs associated with TTP399. vTv aims to improve treatment for type 1 diabetes through these pivotal studies.
vTv Therapeutics Inc. (Nasdaq: VTVT) appointed Paul Sekhri as President and CEO, effective August 1, 2022. The company entered into agreements to raise $35 million by issuing stock to CinRx Pharma and G42 Investments, aimed at supporting clinical trials for TTP399, a treatment for type 1 diabetes. The company reported a net loss of $3.2 million for Q2 2022, compared to a loss of $0.6 million in the same period last year. Cash position improved to $17.9 million. vTv plans to initiate pivotal clinical trials for TTP399 in Q4 2022, engaging approximately 1,000 patients.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced the appointment of Paul Sekhri as President and CEO, effective August 1, 2022. Sekhri, who will also join the Board of Directors, comes at a pivotal time as the company prepares for Phase 3 studies of TTP399, an oral therapy for type 1 diabetes with Breakthrough Therapy designation from the FDA. Positive Phase 2 results showed significant improvements in HbA1c and reduced hypoglycemia rates. A $25 million investment from G42 will help fund the upcoming trials.
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