vTv Therapeutics VTVT

vTv Therapeutics announces Phase 3 CATT1 trial completion

Item 2.02 Reports results

Form
8-K
Filed
Importance
Major
  1. Phase 3 CATT1 trial completed with 166 participants randomized
  2. Topline results expected mid 2027
  3. FDA granted Orphan Drug Designation to HPPD for sickle cell disease

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The reading, claim by claim

  1. Under Item 2.02, it states that it issued a press release that day announcing financial results for the fiscal period ended September 30, 2026, attached as Exhibit 99.1.
  2. Item 2.02 says the information, including Exhibit 99.1, shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934.
  3. Item 9.01 lists the press release dated November 5 2026 as Exhibit 99.1, along with the cover page interactive data file as Exhibit 104.
  4. The press release says the Phase 3 CATT1 trial of cadisegliatin in type 1 diabetes completed enrollment with 166 participants randomized, and topline results are expected in mid 2027.
  5. It also says the first participant was randomized in the Phase 2a Hybrid CATT1 pilot study on October 27, 2026.
  6. The release states that vTv expects, based on its cash position as of September 30, 2026, to have sufficient cash to fund operations well through the CATT1 topline readout.
  7. It also says the FDA granted Orphan Drug Designation to HPPD, being investigated for sickle cell disease.

7 of 7 claims matched the filing text.

For perspective, checked against its own source

From the 10-Q for the quarter ended September 30, 2026

  • In its 10-Q for the quarter ended September 30, 2026, vTv Therapeutics reported revenue of $0 and net income of -$11.6 million.

From the filing

Item 2.02 Results of Operations and Financial Condition

On November 5, 2026, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended September 30, 2026.1 1A copy of the press release is attached as Exhibit 99.11 to this current report on Form 8-K and is incorporated herein by reference.

The information in this report (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of Section 18, of the Securities Exchange Act of 19342, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No. Description

99.1 Press Release dated November 5 2026, announcing financial results for the fiscal quarter ended September 30, 20263

104 Cover Page Interactive Data File (embedded within Inline XBRL document)3

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

VTV THERAPEUTICS INC.

By: /s/ Paul J. Sekhri

Name: Paul J. Sekhri

Title: Chairman, President and Chief Executive Officer

Dated: November 5, 2026

vTv Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Phase 3 CATT1 trial evaluating cadisegliatin for the treatment of type 1 diabetes (T1D) completed enrollment with 166 participants randomized; topline results expected mid 20274 Randomized the first participant in its Phase 2a Hybrid CATT1 pilot study evaluating cadisegliatin in individuals with T1D who use hybrid closed-loop (HCL) insulin delivery systems

Company hosted a Key Opinion Leader (KOL) event in October, highlighting cadisegliatin and its potential to address hypoglycemia in people with T1D

FDA granted Orphan Drug Designation to HPPD, the Company's oral, first-in-class Nrf2/Bach1 modulator being investigated as a potential treatment for sickle cell disease

Strong balance sheet expected to fund operations well through Phase 3 CATT1 topline data readout

HIGH POINT, N.C., November 5, 2026 (GLOBE NEWSWIRE) – vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.

In October 2026, the Company announced completion of enrollment in its Phase 3 CATT1 trial and continues to expect topline results in mid 2027, and randomized the first participant in Hybrid CATT1, its Phase 2a study of cadisegliatin in individuals with T1D who use hybrid closed-loop insulin delivery systems. Based on its cash position as of September 30, 2026, vTv expects to have sufficient cash to fund operations well through the anticipated CATT1 topline data readout.6 Also in October 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to HPPD, the Company's oral drug candidate being investigated as a potential treatment for sickle cell disease.7

"Completing enrollment in the Phase 3 CATT1 trial is a significant milestone for vTv, and we look forward to reporting topline results in mid 2027," said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. "In October we also randomized the first participant in Hybrid CATT1, our Phase 2a study of cadisegliatin in people with T1D who use hybrid closed-loop insulin delivery systems. As the experts at our KOL event made clear, hypoglycemia and its broader impact on blood glucose control remain a persistent burden for people with T1D even with the most advanced insulin delivery technology, and cadisegliatin aims to address exactly that."

"We also continue to make important progress in our broader portfolio of highly differentiated small molecule drug candidates. The FDA recently granted Orphan Drug Designation for HPPD, which has shown promising activity in preclinical models of sickle cell disease. This designation strengthens our ability to advance partnering discussions for this program and provides another opportunity to create value for shareholders."

Recent Company Highlights

• Phase 3 CATT1 Trial Enrollment Completed. In October 2026, the Company announced completion of enrollment in its Phase 3 CATT1 trial evaluating cadisegliatin as an oral adjunctive therapy to insulin in individuals with T1D. A total of 166 participants were randomized to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo over six months. The primary efficacy endpoint will assess the incidence of level 2 and level 3 hypoglycemic events. Topline results are expected in mid 2027.

• Initiation of Cadisegliatin Hybrid Closed-Loop Trial (Hybrid CATT1). On October 27, 2026, the Company announced that the first participant had been randomized in its Phase 2a Hybrid CATT1 pilot study5 evaluating cadisegliatin in individuals with T1D who use hybrid closed-loop (HCL) insulin delivery systems. The Phase 2a Hybrid CATT1 trial is a randomized, double-blind, crossover, multicenter study that will evaluate cadisegliatin in T1D participants using hybrid closed-loop insulin delivery systems to inform the design and operational aspects of future Phase 3 research in this population.

• KOL Event on Cadisegliatin Program. On October 20, 2026, the Company hosted a virtual KOL event featuring T1D experts Schafer Boeder, MD (Paradigm Clinical Research, University of California San Diego) and Klara Klein, MD, PhD (University of North Carolina at Chapel Hill School of Medicine), and acclaimed cellist and T1D advocate Alisa Weilerstein. The event focused on T1D, the significant unmet medical need of hypoglycemia, and the cadisegliatin Phase 3 clinical program. A replay of the event is available in the Investor Relations section of the Company's website.

• Oral Presentation at Breakthrough T1D Clinical & Research Congress 2026. On October 10, 2026, Chief Medical Officer Thomas Strack, M.D., Ph.D., presented research spotlighting hypoglycemia-related burdens among adults with T1D using automated insulin delivery (AID) systems at the inaugural Breakthrough T1D Clinical & Research Congress (CRC 2026) in Philadelphia, PA. The research, a quantitative online survey commissioned by vTv and conducted by dQ&A Market Research, Inc., examined 674 adults with T1D, of whom 429 were using AID systems. After accounting for overlap across burden dimensions and weighting for A1C,

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