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vTv Therapeutics completes 166-person CATT1 enrollment

vTv Therapeutics Inc. completed enrollment in its Phase 3 CATT1 trial of cadisegliatin for type 1 diabetes, with 166 participants randomized to cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo over six months.

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Rhea-AI Filing Summary

vTv Therapeutics Inc. completed enrollment in its Phase 3 CATT1 trial of cadisegliatin for type 1 diabetes, with 166 participants randomized to cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo over six months. The primary endpoint measures level 2 and level 3 hypoglycemic events; topline results are expected in mid 2027. The company also randomized the first participant in its Phase 2a Hybrid CATT1 study of people using hybrid closed-loop insulin systems.

Cash and cash equivalents were $77.2 million as of September 30, 2026, compared with $88.9 million as of December 31, 2025; vTv expects cash to fund operations well through the anticipated CATT1 readout. Third-quarter R&D expenses were $7.5 million and G&A expenses were $4.9 million, versus $7.0 million and $3.7 million a year earlier. Net loss attributable to vTv shareholders was $11.6 million, compared with $8.7 million. Revenue for the nine months ended September 30, 2026, was $36.839 million, versus $0 in 2025. The FDA granted Orphan Drug Designation to HPPD, an investigational candidate for sickle cell disease.

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Positive

  • Moderate pointPhase 3 CATT1 enrollment completed: 166 participants randomized.
  • Moderate pointNine-month revenue was $36.839 million, versus $0 in 2025.

Negative

  • Moderate pointQuarterly net loss attributable to vTv shareholders rose to $11.6 million from $8.7 million.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
CATT1 participants randomized 166 participants Phase 3 CATT1 trial
Cash and cash equivalents $77.2 million As of September 30, 2026; $88.9 million as of December 31, 2025
Nine-month revenue $36.839 million Nine months ended September 30, 2026; $0 for the comparable 2025 period
Quarterly R&D expenses $7.5 million Three months ended September 30, 2026; $7.0 million in 2025
Quarterly G&A expenses $4.9 million Three months ended September 30, 2026; $3.7 million in 2025
Quarterly net loss attributable to vTv shareholders $11.6 million Three months ended September 30, 2026; $8.7 million in 2025
Orphan Drug Designation regulatory
"FDA granted Orphan Drug Designation to HPPD"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
hybrid closed-loop medical
"use hybrid closed-loop insulin delivery systems"
A hybrid closed-loop is an automated insulin-delivery system that links a continuous glucose monitor with an insulin pump and a control algorithm to adjust background (basal) insulin dosing in real time, while the user still manually tells the system about meals and gives extra insulin for them. Think of it as cruise control that handles steady driving but still needs the driver to accelerate for hills — investors watch it as a sign of advanced, recurring-revenue medical technology with strong regulatory and adoption implications.
level 2 and level 3 hypoglycemic events medical
"incidence of level 2 and level 3 hypoglycemic events"
glucokinase activator medical
"potential first-in-class oral glucokinase activator"
A glucokinase activator is a drug that boosts the activity of glucokinase, an enzyme that helps the liver and pancreas sense and lower blood sugar. Think of it as turning up the sensitivity of the body’s sugar thermostat so insulin release and sugar storage respond more effectively; for investors, these drugs matter because they can become new diabetes treatments with sizable market potential while carrying typical development, safety and regulatory risks that affect a company’s value.
Nrf2/Bach1 modulator medical
"oral, first-in-class Nrf2/Bach1 modulator"
Revenue (nine months) $36.839 million Compared with $0 for the nine months ended September 30, 2025
R&D expenses $7.5 million Compared with $7.0 million for the three months ended September 30, 2025
G&A expenses $4.9 million Compared with $3.7 million for the three months ended September 30, 2025
Net loss attributable to vTv shareholders $11.6 million Compared with $8.7 million for the three months ended September 30, 2025
Cash and cash equivalents $77.2 million as of September 30, 2026 Compared with $88.9 million as of December 31, 2025

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many participants were randomized in VTVT's CATT1 trial?

The CATT1 Phase 3 trial randomized 166 participants to cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo over six months. Its primary efficacy endpoint is the incidence of level 2 and level 3 hypoglycemic events.

When are VTVT's CATT1 results expected?

vTv expects topline CATT1 results in mid 2027. The company said cash on hand as of September 30, 2026, is expected to fund operations well through the anticipated readout.

What were VTVT's Q3 2026 net loss and cash balance?

Net loss attributable to vTv shareholders was $11.6 million for the third quarter of 2026, compared with $8.7 million for the comparable 2025 period. Cash and cash equivalents were $77.2 million as of September 30, 2026, compared with $88.9 million as of December 31, 2025.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FALSE0001641489Nasdaq00016414892026-11-052026-11-05

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (date of earliest event reported):  November 5, 2026
vTv Therapeutics Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-37524
47-3916571
(State or other jurisdiction
of incorporation)
(Commission File No.)
(IRS Employer
Identification No.)
3980 Premier Drive, Suite 110
High Point, NC 27265
(Address of principal executive offices)
(336) 841-0300
(Registrant’s telephone number, including area code)
NOT APPLICABLE
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Class A common stock, par value $0.01 per shareVTVT
Nasdaq Capital Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨



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.  A copy of the press release is attached as Exhibit 99.1 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 1934, 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, 2026
104Cover Page Interactive Data File (embedded within Inline XBRL document)



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


Exhibit 99.1
newvtvimage30042424.jpg                    

            
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 2027
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. 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.
“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 study 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, approximately 54% of adults with T1D using an AID system were estimated to experience at least one of four dimensions of hypoglycemia-related burden, reinforcing that hypoglycemia continues to shape daily glucose management despite advances in insulin delivery technology.
•FDA Orphan Drug Designation for HPPD. On October 6, 2026, the FDA granted Orphan Drug Designation to HPPD (HPP8668), an oral, first-in-class Nrf2/Bach1 modulator being investigated as a treatment for sickle cell disease. Preclinical studies conducted at Augusta University using the Townes sickle cell disease mouse model showed that HPPD was orally active and well tolerated, increased fetal hemoglobin, and reduced oxidative stress and red blood cell sickling. The designation will support partnering discussions for HPPD as the Company continues to prioritize cadisegliatin in T1D.
Third Quarter 2026 Financial Results
•Cash Position: Cash and cash equivalents as of September 30, 2026, were $77.2 million compared to $88.9 million as of December 31, 2025.
•Research & Development (R&D) Expenses: R&D expenses were $7.5 million and $7.0 million for the three months ended September 30, 2026, and 2025, respectively. The increase was primarily driven by continued investment in the Phase 3 CATT1 trial.
•General & Administrative (G&A) Expenses: G&A expenses were $4.9 million and $3.7 million for the three months ended September 30, 2026, and 2025, respectively. The increase was primarily driven by higher share-based compensation and payroll-related expenses.
•Interest Income: Interest income for the three months ended September 30, 2026, and 2025, of $0.7 million and $0.4 million, respectively, was related to dividend income from the Company's money market accounts.



•Net Loss: Net loss attributable to vTv shareholders for the three months ended September 30, 2026, was $11.6 million or $0.94 per basic and diluted share. Net loss attributable to vTv shareholders for the comparable period a year ago was $8.7 million or $1.08 per basic and diluted share.

Upcoming Events
9th Annual Evercore HealthCONx Conference
Format: Fireside Presentation and 1x1 Investor Meetings
Location: Coral Gables, FL
Date: December 2, 2026



vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
September 30,
2026
December 31,
2025
(Unaudited)
Assets
Current assets:
Cash and cash equivalents$77,164 $88,932 
Prepaid expenses and other current assets1,440 961 
Total current assets78,604 89,893 
Other assets3 6 
Total assets$78,607 $89,899 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable and accrued expenses$7,024 $6,557 
Warrant liability, related party— 84 
Total current liabilities7,024 6,641 
Contract liabilities1,830 18,669 
Warrant liability67 152 
Total liabilities8,921 25,462 
Commitments and contingencies
Stockholders’ equity:
Class A Common Stock40 39 
Class B Common Stock— — 
Additional paid-in capital396,878 391,090 
Accumulated deficit(327,232)(326,692)
Total stockholders’ equity69,686 64,437 
Total liabilities and stockholders’ equity $78,607 $89,899 



vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)

Three Months Ended
September 30,
Nine Months Ended
September 30,
2026202520262025
(Unaudited)(Unaudited)
Revenue $— $— $36,839 $— 
Operating expenses:
Research and development 7,531 7,020 25,279 13,953 
General and administrative 4,895 3,679 14,653 10,970 
Total operating expenses 12,426 10,699 39,932 24,923 
Operating loss (12,426)(10,699)(3,093)(24,923)
Interest income734 399 2,384 1,005 
Interest expense— (5)— (5)
Other income (expense), net
72 (40)169 (19)
Net loss before income taxes and noncontrolling interest(11,620)(10,345)(540)(23,942)
Income tax provision— — — — 
Net loss before noncontrolling interest(11,620)(10,345)(540)(23,942)
Less: net loss attributable to noncontrolling interest— (1,647)— (4,106)
Net loss attributable to vTv Therapeutics Inc.$(11,620)$(8,698)$(540)$(19,836)
Net loss attributable to vTv Therapeutics Inc. common shareholders$(11,620)$(8,698)$(540)$(19,836)
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted$(0.94)$(1.08)$(0.04)$(2.80)
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted12,423,917 8,055,940 12,414,224 7,080,681 
About the Phase 3 CATT1 Study
Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes (CATT1) (NCT06334133) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of cadisegliatin over six months in individuals with T1D 18 years or older who are on multiple daily insulin injections or continuous subcutaneous insulin infusion, along with continuous glucose monitoring. Participants were randomized to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo. The primary efficacy endpoint will assess the incidence of level 2 and level 3 hypoglycemic events. Secondary endpoints include changes in hemoglobin A1c (HbA1c), time in target glucose range, and the incidence of diabetic ketoacidosis in cadisegliatin-treated participants compared with placebo. Additional information about the study is available at https://clinicaltrials.gov/study/NCT06334133.
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small-molecule, liver-selective glucokinase activator being investigated in the U.S. as a potential first-in-class oral adjunctive treatment for T1D. In nonclinical studies, cadisegliatin acted selectively on the liver and increased the activity of glucokinase independently of insulin. These studies support clinical investigation of whether cadisegliatin can improve glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).
Cadisegliatin is under investigation, and its safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.
About HPPD
HPPD (HPP8668) is an investigational, oral, first-in-class Nrf2/Bach1 modulator being developed by vTv Therapeutics for the treatment of sickle cell disease. Preclinical studies in the Townes sickle cell disease mouse model have shown that HPPD induces fetal hemoglobin (HbF) in a time- and dose-dependent manner, with effects comparable to or exceeding hydroxyurea,



the current standard HbF-inducing therapy. In addition to HbF induction, HPPD showed reductions in oxidative stress and sickled red blood cells, supporting its potential as a disease-modifying oral therapy with a differentiated mechanism of action. HPPD is under investigation, and safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.
About vTv Therapeutics
vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv's clinical pipeline is led by cadisegliatin, a potential first-in-class oral glucokinase activator being investigated in a U.S. Phase 3 study for the treatment of T1D. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn.
Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other variations or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, the timing of initiation and conduct of the Phase 2a Hybrid CATT1 study, the sufficiency of our cash to fund operations through the anticipated Phase 3 CATT1 topline data readout, potential partnering of HPPD, the anticipated effect of Phase 3 topline data on the Company, the benefits of cadisegliatin to people living with T1D, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements.

Investor Contact
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

Media Contact
Caren Begun
TellMed Strategies
201-396-8551
caren.begun@tmstrat.com


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