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vTv Therapeutics Announces 2022 Third Quarter Financial Results and Provides Corporate Update
- Company on-track to initiate Phase 3 clinical trials of TTP399 in the first quarter of 2023
- Industry veteran
Paul Sekhrijoins the Company as President, Chief Executive Officer, and member of the Board of Directors
- Agreements with CinRx Pharma and a subsidiary to provide additional capital and access to CinRx’s industry and clinical trial expertise to support advancement of TTP399
“During the third quarter, we continued working diligently toward the commencement of TTP399 Phase 3 clinical trials, which we expect to initiate in 1Q2023,” said
- Leadership. On
July 27, 2022, the Company appointed Paul Sekhrias President, Chief Executive Officer (CEO) effective August 1, 2022, and was confirmed as a member of the board of directors on August 9, 2022. Mr. Sekhribrings nearly 30 years of healthcare industry experience, including serving as President and CEO of several healthcare companies, experience in several senior business development and strategy roles and he has been a director on more than 30 private, public company and non-profit boards.
- Partnership. On
July 25, 2022, the Company entered into agreements with CinRx Pharma and its subsidiary, CinPax. CinPax agreed to acquire $10.0 millionin vTv Class A common stock at approximately $2.41per share with $6 millionpaid at closing and the remaining $4.0 millionpayable on November 22, 2022. vTv will issue warrants to CinRx to acquire 1.2 million additional shares of Class A common stock at an exercise price of approximately $0.72per share that become exercisable upon agreed vesting triggers. In addition, the agreements set forth terms under which vTv will leverage the CinRx team’s industry experience to collaborate on the oversight of the clinical trials for pharmaceutical products that contain TTP399.
Upcoming Milestones and Events
- Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with T1D and has engaged with the FDA on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1,000 patients and at least one of the studies will be one year of treatment. The FDA and the Company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemic events. These pivotal studies are expected to start in the first quarter of 2023.
Third Quarter 2022 Financial Results
- Cash Position: The Company’s cash position as of
September 30, 2022, was $15.3 millioncompared to $13.4 millionas of December 31, 2021.
- Research & Development (R&D) Expenses: R&D expenses were
$3.1 millionand $2.4 millionin each of the three months ended September 30, 2022, and 2021, respectively. The increase of $0.7 millionis attributable to a decrease in clinical trial costs for azeliragon, which was mainly driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes and a decrease in spending related to a multiple ascending dose study for HPP737, due to its completion in 2021, offset by higher spending on TTP399 due to drug product related costs and trial preparation costs.
- General & Administrative (G&A) Expenses: G&A expenses were
$2.6 millionand $2.2 millionfor each of the three months ended September 30, 2022, and 2021, respectively. The increase was due to higher legal expense and higher other G&A costs offset by lower payroll costs.
- Other (Expense)/Income: Other expense for the three months ended
September 30, 2022, was $0.1 millionand was driven by an unrealized gain related to the investment in Reneo as well as the losses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party (“Related Party Warrants”). Other income for the three months ended September 30, 2021, was $0.2 millionand was related to the unrealized loss recognized related to the investment in Reneo as well as gains related to the change in the fair value of the outstanding warrants in our own stock held by a related party.
- Net Loss: Net loss attributable to vTv shareholders for the three months ended
September 30, 2022, was $4.3 millionor $0.05per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $1.1 millionor $0.02per basic share.
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||15,339||$||13,415|
|Promissory note receivable||12,091||—|
|Prepaid expenses and other current assets||1,281||2,049|
|Total current assets||28,783||15,621|
|Property and equipment, net||230||278|
|Operating lease right-of-use assets||328||402|
|Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit|
|Accounts payable and accrued expenses||$||6,676||$||8,023|
|Current portion of operating lease liabilities||208||184|
|Current portion of contract liabilities||26||35|
|Current portion of notes payable||557||256|
|Total current liabilities||7,467||8,498|
|Contract liabilities, net of current portion||18,669||—|
|Operating lease liabilities, net of current portion||333||492|
|Warrant liability, related party||1,409||1,262|
|Commitments and contingencies|
|Redeemable noncontrolling interest||24,207||24,962|
|Class A Common Stock||815||669|
|Class B Common Stock||232||232|
|Promissory note receivable for common stock||(4,000||)||—|
|Additional paid-in capital||253,446||238,193|
|Total stockholders’ deficit attributable to
|Total liabilities, redeemable noncontrolling interest and stockholders’ deficit||$||35,516||$||25,474|
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||3,055||2,382||8,393||7,922|
|General and administrative||2,634||2,221||9,813||6,627|
|Total operating expenses||5,689||4,603||18,206||14,549|
|Other income, net||79||244||(2,777||)||2,425|
|Loss before income taxes||(5,468||)||(1,365||)||(18,783||)||(8,133||)|
|Income tax provision||—||100||200||115|
|Net loss before noncontrolling interest||(5,468||)||(1,465||)||(18,983||)||(8,248||)|
|Less: Net loss attributable to noncontrolling interest||(1,207||)||(378||)||(4,564||)||(2,312||)|
|Net loss attributable to
|Net loss attributable to
|Net loss per share of
|Weighted average number of
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 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
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Source: vTv Therapeutics Inc.