vTv Therapeutics Announces 2023 Fourth Quarter and Full Year Financial Results and Provides Corporate Update
- Positive: Raised $51 million through a private placement for Phase 3 trial of cadisegliatin, strengthening financial position.
- Positive: Submitted study protocol to FDA for Phase 3 trial in adults with T1D, with enrollment expected to start in Q2 2024.
- Positive: Collaboration with G42 for Phase 2 study in type 2 diabetes, targeting initiation in 2024.
- Negative: Net loss of $20.3 million for full year 2023, with decreased cash position compared to the previous year.
- Negative: Increase in R&D expenses in 2023, attributed to higher spending on cadisegliatin and trial preparation costs.
- None.
Insights
The recent private placement of $51 million is a significant event for vTv Therapeutics Inc., as it provides the necessary capital to fund its upcoming Phase 3 trial of cadisegliatin for type 1 diabetes. This influx of capital is crucial because clinical trials are often the most expensive stage of drug development. The involvement of healthcare-focused institutional investors, including Samsara BioCapital and the JDRF T1D Fund, signals confidence in the potential of cadisegliatin and its market prospects. It is important to consider that the company's cash position, bolstered by the private placement, is expected to sustain operations through the anticipated release of top-line data from the Phase 3 study.
The reduction of R&D expenses in Q4 2023 compared to the same period in the previous year may reflect a strategic allocation of resources towards the upcoming trial. However, an increase in R&D expenses year-over-year indicates ongoing investment in the company’s pipeline. The net loss per share has decreased year-over-year, which may be viewed positively by investors, as it could indicate improved operational efficiency or cost management.
Investors should monitor the progress of the Phase 3 trial closely, as successful outcomes can lead to FDA approval and commercialization, which would have a significant impact on the company's revenue and profitability. Conversely, any setbacks in the trial could adversely affect the company's financial health and stock performance.
The initiation of patient enrollment for the Phase 3 clinical trial of cadisegliatin in Q2 2024 marks a pivotal step for vTv Therapeutics in addressing type 1 diabetes (T1D), a chronic condition with limited oral therapeutic options. Cadisegliatin's advancement into late-stage trials underscores its potential efficacy and safety profile, previously established in earlier phases of clinical research. The primary efficacy endpoint focusing on the incidence of Level 2 or Level 3 hypoglycemic events is particularly relevant, as hypoglycemia is a common and dangerous complication of insulin therapy in T1D patients.
The company's strategic partnership with G42 for a Phase 2 study in type 2 diabetes diversifies its portfolio and could open up a larger market opportunity, given the higher prevalence of type 2 diabetes. The outcomes of these trials are critical, as they will determine the drug's viability and competitive positioning in a market that is actively seeking innovative treatments for diabetes management.
Given the complexity and costs associated with bringing new drugs to market, the company's current cash reserves and burn rate will be important metrics for stakeholders to watch, alongside the clinical trial results.
vTv Therapeutics' focus on diabetes treatment comes at a time when the global diabetes drug market is expanding, driven by a rising prevalence of the disease and a demand for novel therapies. The company's decision to prioritize the development of an oral adjunctive therapy is strategic, considering patient preference for oral medication over injectables and the potential for better compliance.
The market's response to vTv's recent developments will depend on the perceived value of cadisegliatin relative to existing treatments and the unmet need it aims to address. The company's ability to successfully navigate the clinical and regulatory process will be instrumental in determining its future market share and growth potential within the diabetes care sector.
It is also noteworthy that the company has streamlined its Board of Directors, which could be interpreted as a move towards greater operational efficiency and governance that aligns with investor interests. The designation of three Board members by the new investors may bring fresh perspectives and potentially influence the company's strategic direction.
- Recently completed
$51 million PIPE from healthcare-focused institutional investors and the JDRF T1D Fund. - Company's first Phase 3 clinical trial of cadisegliatin (TTP399), an oral adjunctive therapy to insulin, for the treatment of type 1 diabetes, expected to initiate patient enrollment in the second quarter of 2024.
- In connection with the PIPE, vTv has reduced the size of its Board of Directors from nine to seven members. Three of the Board members will be designated by the new investors, and include Srinivas Akkaraju, MD, PhD, Founder and Managing General Partner at Samsara.
HIGH POINT, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of an oral adjunctive therapy to insulin for the treatment of type 1 diabetes (T1D), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided an update on recent corporate developments.
“We made important progress in the fourth quarter of 2023 and have started 2024 on a positive note following the recently announced private placement through which we raised
Recent Company Highlights
- On March 4, 2024, the Company announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate, cadisegliatin, in adults diagnosed with T1D.
- On February 28, 2024, the Company received
$51 million from a private placement to healthcare-focused institutional investors, including a life sciences-focused institutional investor, Samsara BioCapital, LLC (“Samsara”) and the JDRF T1D Fund.
Upcoming Milestones and Events
- Phase 3 Study Planning. The first Phase 3 randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of the Company's lead drug candidate, cadisegliatin, in adults diagnosed with T1D is expected to enroll approximately 150 patients at up to 20 sites in the United States, with the first patient expected to be enrolled in the second quarter of 2024. The Phase 3 study will assess two doses of orally administered cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use a continuous glucose monitor (CGM). The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.
- Phase 2 Study in Type 2 Diabetes. In collaboration with G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, the Company is preparing to sponsor a Phase 2 study comparing cadisegliatin with placebo in approximately 600 patients with type 2 diabetes on insulin therapy. This study is expected to be initiated in 2024.
Fourth Quarter 2023 Financial Results
- Cash Position: The Company’s cash position as of December 31, 2023, was
$9.4 million compared to$12.1 million as of December 31, 2022. The Company believes that its cash position, including the proceeds of the$51 million private placement completed on February 28, 2024, will be sufficient to fund operations through the release of top-line data from its first Phase 3 study of cadisegliatin. - Research & Development (R&D) Expenses: R&D expenses were
$2.1 million and$4.0 million in each of the three months ended December 31, 2023 and 2022, respectively. The decrease of$1.9 million is attributable to decreased spending on cadisegliatin (TTP399) due to drug product related costs and trial preparation costs. - General & Administrative (G&A) Expenses: G&A expenses were
$2.6 million and$2.4 million for each of the three months ended December 31, 2023 and 2022, respectively. The increase of$0.2 million was due to i) higher share-based compensation expense, ii) higher payroll and other G&A costs offset by iii) lower legal expense. - Other Income: Other income for the three months ended December 31, 2023, was
$0.2 million and was driven by gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to related parties (“Related Party Warrants”). Other income for the three months ended December 31, 2022, was$0.1 million and was driven by gains related to the change in the fair value of the outstanding Related Party Warrants offset by an unrealized loss recognized related to the Company’s investment in Reneo. - Net Loss: Net loss attributable to vTv shareholders for the three months ended December 31, 2023, was
$3.5 million or$1.67 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was$4.7 million or$2.28 per basic share.
Full Year 2023 Financial Results
- Research & Development (R&D) Expenses: R&D expenses were
$13.6 million and$12.4 million in each of the years ended December 31, 2023 and 2022, respectively. The increase is attributable to i) higher spending on cadisegliatin due to increases in drug product related costs as well as higher spending on trial preparation costs, and ii) an increase in indirect costs and other projects. - General & Administrative (G&A) Expenses: G&A expenses were
$11.9 million and$12.2 million for each of the years ended December 31, 2023 and 2022, respectively. The decrease of$0.3 million was due to i) lower legal expense and severance costs offset by ii) higher payroll and other G&A costs. - Other Expense, net: Other expense for the year ended December 31, 2023, was
$0.9 million and was driven by the recording of an impairment charge on a cost-method investment offset by a realized gain recognized related to the Company’s Repurchase Agreement with Reneo Pharmaceuticals Inc., as well as gains related to the change in the fair value of the outstanding Related Party Warrants. Other expense for the year ended December 31, 2022, was$2.7 million and was driven by an unrealized loss recognized related to the Company’s investment in Reneo, offset by gains related to the change in the fair value of the outstanding Related Party Warrants. - Net Loss: Net loss attributable to vTv shareholders for the year ended December 31, 2023, was
$20.3 million or$9.71 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was$19.2 million or$9.98 per basic share.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| December 31, 2023 | December 31, 2022 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 9,446 | $ | 12,126 | |||
| Accounts receivable, net | 102 | 173 | |||||
| Promissory note receivable | — | 12,243 | |||||
| Prepaid expenses and other current assets | 1,044 | 2,537 | |||||
| Current deposits | 65 | 15 | |||||
| Total current assets | 10,657 | 27,094 | |||||
| Property and equipment, net | 117 | 207 | |||||
| Operating lease right-of-use assets | 244 | 349 | |||||
| Long-term investments | — | 5,588 | |||||
| Total assets | $ | 11,018 | $ | 33,238 | |||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 10,242 | $ | 7,313 | |||
| Current portion of operating lease liabilities | 169 | 154 | |||||
| Current portion of contract liabilities | 17 | 17 | |||||
| Current portion of notes payable | 191 | 224 | |||||
| Total current liabilities | 10,619 | 7,708 | |||||
| Contract liabilities, net of current portion | 18,669 | 18,669 | |||||
| Operating lease liabilities, net of current portion | 169 | 338 | |||||
| Warrant liability, related party | 110 | 684 | |||||
| Total liabilities | 29,567 | 27,399 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 6,131 | 16,579 | |||||
| Stockholders’ deficit: | |||||||
| Class A Common Stock (*) | 21 | 21 | |||||
| Class B Common Stock (*) | 6 | 6 | |||||
| Additional paid-in capital (*) | 256,335 | 254,757 | |||||
| Accumulated deficit | (281,042 | ) | (265,524 | ) | |||
| Total stockholders’ deficit attributable to vTv Therapeutics Inc. | (24,680 | ) | (10,740 | ) | |||
| Total liabilities, redeemable noncontrolling interest and stockholders’ deficit | $ | 11,018 | $ | 33,238 | |||
| (*) Adjusted retroactively for reverse stock split | |||||||
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
| Three Months Ended December 31, | For the Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Revenue | $ | — | $ | 9 | $ | — | $ | 2,018 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 2,138 | 3,964 | 13,595 | 12,357 | |||||||||||
| General and administrative | 2,569 | 2,388 | 11,907 | 12,201 | |||||||||||
| Total operating expenses | 4,707 | 6,352 | 25,502 | 24,558 | |||||||||||
| Operating loss | (4,707 | ) | (6,343 | ) | (25,502 | ) | (22,540 | ) | |||||||
| Interest income | 88 | 152 | 472 | 352 | |||||||||||
| Interest expense | (7 | ) | (6 | ) | (13 | ) | (15 | ) | |||||||
| Other income (expense), net | 185 | 107 | (923 | ) | (2,670 | ) | |||||||||
| Loss before income taxes | (4,441 | ) | (6,090 | ) | (25,966 | ) | (24,873 | ) | |||||||
| Income tax provision | — | — | — | 200 | |||||||||||
| Net loss before noncontrolling interest | (4,441 | ) | (6,090 | ) | (25,966 | ) | (25,073 | ) | |||||||
| Less: Net loss attributable to noncontrolling interest | (963 | ) | (1,345 | ) | (5,716 | ) | (5,909 | ) | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (3,478 | ) | $ | (4,745 | ) | $ | (20,250 | ) | $ | (19,164 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (3,478 | ) | $ | (4,745 | ) | $ | (20,250 | ) | $ | (19,164 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted | $ | (1.67 | ) | $ | (2.28 | ) | $ | (9.71 | ) | $ | (9.98 | ) | |||
| Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted | 2,084,973 | 2,084,973 | 2,084,973 | 1,919,788 | |||||||||||
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin (TTP399), a potential oral adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications including type 2 diabetes and other chronic conditions.
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,” "seek," “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, 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 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, merger, dispositions, joint ventures, or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.
Contacts:
Investors:
Lee Roth
Burns McClellan
lroth@burnsmc.com
Media:
Selina Husain / Robert Flamm, Ph.D.
Burns McClellan, Inc.
shusain@burnsmc.com / rflamm@burnsmc.com
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