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vTv Therapeutics Announces 2024 Third Quarter Financial Results and Provides Corporate Update

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vTv Therapeutics (Nasdaq: VTVT) announced its 2024 third quarter financial results and provided a corporate update. The company reported a cash position of $41.6 million as of September 30, 2024, up from $9.4 million at the end of 2023, largely due to private placement financing and ATM Offering proceeds. R&D expenses rose to $3.2 million from $2.8 million due to higher indirect costs, offset by lower spending on cadisegliatin. G&A expenses increased to $3.3 million from $2.5 million, driven by higher share-based, legal, and payroll costs. The net loss attributable to shareholders was $4.8 million or $0.88 per share, down from $6.7 million or $3.19 per share a year ago. The company’s lead program, cadisegliatin, is under FDA clinical hold, but discussions are ongoing. Total assets were $43.2 million, and total liabilities were $25.3 million as of September 30, 2024.

vTv Therapeutics (Nasdaq: VTVT) ha annunciato i risultati finanziari del terzo trimestre del 2024 e fornito un aggiornamento aziendale. L'azienda ha riportato una posizione di cassa di 41,6 milioni di dollari al 30 settembre 2024, rispetto ai 9,4 milioni di dollari alla fine del 2023, in gran parte grazie ai proventi di finanziamenti tramite collocamento privato e Offerta ATM. Le spese di R&D sono aumentate a 3,2 milioni di dollari dai 2,8 milioni di dollari, a causa di costi indiretti più elevati, compensati però da minori spese per cadisegliatin. Le spese generali e amministrative sono aumentate a 3,3 milioni di dollari dai 2,5 milioni di dollari, guidate da maggiori costi legati a quote azionarie, legali e stipendi. La perdita netta attribuibile agli azionisti è stata di 4,8 milioni di dollari, ossia 0,88 dollari per azione, in diminuzione rispetto ai 6,7 milioni di dollari o 3,19 dollari per azione dell'anno precedente. Il programma principale dell'azienda, cadisegliatin, è attualmente sospeso dalla FDA, ma sono in corso discussioni. Gli attivi totali ammontavano a 43,2 milioni di dollari e le passività totali a 25,3 milioni di dollari al 30 settembre 2024.

vTv Therapeutics (Nasdaq: VTVT) anunció sus resultados financieros del tercer trimestre de 2024 y proporcionó una actualización corporativa. La empresa reportó una posición de efectivo de 41,6 millones de dólares al 30 de septiembre de 2024, un aumento respecto a los 9,4 millones de dólares a finales de 2023, principalmente debido a financiamiento por colocación privada y los ingresos de la Oferta ATM. Los gastos de I+D aumentaron a 3,2 millones de dólares desde 2,8 millones de dólares, por costos indirectos más altos, compensados por menores gastos en cadisegliatin. Los gastos generales y administrativos subieron a 3,3 millones de dólares desde 2,5 millones de dólares, impulsados por mayores costos relacionados con acciones, legales y de nómina. La pérdida neta atribuible a los accionistas fue de 4,8 millones de dólares o 0,88 dólares por acción, en comparación con 6,7 millones de dólares o 3,19 dólares por acción hace un año. El programa líder de la compañía, cadisegliatin, se encuentra bajo una suspensión clínica de la FDA, pero las discusiones continúan. Los activos totales fueron de 43,2 millones de dólares y las obligaciones totales fueron de 25,3 millones de dólares al 30 de septiembre de 2024.

vTv Therapeutics (Nasdaq: VTVT)는 2024년 3분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 회사는 2024년 9월 30일 기준으로 현금 보유액이 4160만 달러에 달하며, 이는 2023년 말 940만 달러에서 증가한 수치로, 대부분은 사모 배치 금융과 ATM 공모에 따른 결과입니다. R&D 비용은 간접 비용 증가로 인해 280만 달러에서 320만 달러로 증가했으며, cadisegliatin에 대한 지출 감소로 상쇄되었습니다. 일반 관리 비용은 250만 달러에서 330만 달러로 증가했으며, 이는 주식 기반, 법률 및 급여 비용의 증가에 의해 주도되었습니다. 주주에게 귀속되는 순손실은 480만 달러로 주당 0.88달러이며, 이는 작년 670만 달러 또는 주당 3.19달러에서 감소한 수치입니다. 회사의 주요 프로그램인 cadisegliatin은 FDA의 임상 보류 상태에 있지만 논의가 진행 중입니다. 2024년 9월 30일 기준으로 총 자산은 4320만 달러였고, 총 부채는 2530만 달러였습니다.

vTv Therapeutics (Nasdaq: VTVT) a annoncé ses résultats financiers pour le troisième trimestre de 2024 et a fourni une mise à jour de l'entreprise. La société a signalé une position de trésorerie de 41,6 millions de dollars au 30 septembre 2024, en hausse par rapport à 9,4 millions de dollars à la fin de 2023, principalement en raison d'un financement par placement privé et des recettes de l'Offre ATM. Les dépenses de R&D ont augmenté à 3,2 millions de dollars contre 2,8 millions de dollars en raison de coûts indirects plus élevés, compensés par une baisse des dépenses pour le cadisegliatin. Les dépenses générales et administratives ont augmenté à 3,3 millions de dollars contre 2,5 millions de dollars, en raison de coûts plus élevés liés aux actions, juridiques et de paie. La perte nette attribuable aux actionnaires était de 4,8 millions de dollars ou 0,88 dollar par action, en baisse par rapport à 6,7 millions de dollars ou 3,19 dollars par action l'année précédente. Le principal programme de l'entreprise, le cadisegliatin, est en attente d'une autorisation clinique de la FDA, mais des discussions sont en cours. Les actifs totaux étaient de 43,2 millions de dollars et les passifs totaux de 25,3 millions de dollars au 30 septembre 2024.

vTv Therapeutics (Nasdaq: VTVT) hat seine finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Das Unternehmen meldete eine Liquiditätsposition von 41,6 Millionen Dollar zum 30. September 2024, ein Anstieg von 9,4 Millionen Dollar zum Jahresende 2023, hauptsächlich aufgrund von Finanzierungen durch private Platzierungen und den Erträgen aus dem ATM-Angebot. Die F&E-Ausgaben stiegen auf 3,2 Millionen Dollar von 2,8 Millionen Dollar aufgrund höherer indirekter Kosten, die jedoch durch niedrigere Ausgaben für cadisegliatin ausgeglichen wurden. Die Allgemeine Verwaltungsaufwendungen erhöhten sich auf 3,3 Millionen Dollar von 2,5 Millionen Dollar, bedingt durch höhere aktienbasierte, rechtliche und Lohnkosten. Der Nettoverlust, der den Aktionären zuzurechnen ist, betrug 4,8 Millionen Dollar oder 0,88 Dollar pro Aktie, ein Rückgang von 6,7 Millionen Dollar oder 3,19 Dollar pro Aktie im Vorjahr. Das Hauptprogramm des Unternehmens, cadisegliatin, befindet sich unter einem klinischen Halt der FDA, aber Gespräche sind im Gange. Die Gesamtaktiva beliefen sich auf 43,2 Millionen Dollar und die Gesamtverbindlichkeiten auf 25,3 Millionen Dollar zum 30. September 2024.

Positive
  • Cash position increased to $41.6 million from $9.4 million.
  • Net loss reduced to $4.8 million from $6.7 million year-over-year.
Negative
  • R&D expenses increased to $3.2 million from $2.8 million.
  • G&A expenses increased to $3.3 million from $2.5 million.
  • Cadisegliatin program under FDA clinical hold.

Insights

The Q3 2024 results reveal mixed financial signals. While the cash position strengthened significantly to $41.6 million from $9.4 million at year-end 2023, operational metrics show concerning trends. R&D expenses increased by 14% to $3.2 million, while G&A costs rose by 32% to $3.3 million. The net loss per share improved to $0.88 from $3.19, but this was mainly due to share dilution from recent financing activities.

The FDA clinical hold on cadisegliatin remains a significant headwind. While the company maintains a stronger balance sheet, the increased operational costs without corresponding revenue generation points to continued cash burn. The substantial contract liabilities of $18.7 million and accumulating deficit of $296.1 million raise concerns about long-term sustainability.

The clinical hold on cadisegliatin by the FDA represents a critical setback for vTv's diabetes program. While management indicates progress in addressing the hold, no specific timeline or resolution details were provided. This uncertainty impacts the development timeline for their lead asset in type 1 diabetes treatment.

The reduced spending on toxicity studies and drug manufacturing for cadisegliatin, coupled with increased clinical trial start-up costs, suggests a strategic pivot in response to regulatory challenges. Without clear visibility on the FDA's requirements or potential timeline for resolution, the program faces significant uncertainty that could impact both development timelines and future capital requirements.

HIGH POINT, N.C., Nov. 12, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company with a portfolio of novel small molecules and a lead program in diabetes, today reported financial results for the third quarter ended September 30, 2024, and provided an update on recent corporate developments.

"Our cadisegliatin program continues to show promise as a new oral adjunct therapy being investigated for improvement in glycemic control and reduction of hypoglycemia in patients with type 1 diabetes. During the quarter, our team made progress addressing the basis for the clinical hold placed on our clinical program by the Food and Drug Administration in July,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. "We look forward to continuing our discussion with the FDA regarding the clinical hold and our clinical program for cadisegliatin."

Third Quarter 2024 Financial Results

  • Cash Position: The Company’s cash position as of September 30, 2024, was $41.6 million compared to $9.4 million as of December 31, 2023. This increase is largely due to proceeds from the private placement financing on February 27, 2024, and additional funds from the ATM Offering during the quarter ended September 30, 2024.
  • Research & Development (R&D) Expenses: R&D expenses were $3.2 million and $2.8 million in each of the three months ended September 30, 2024, and 2023, respectively. The increase reflects higher indirect costs and other project-related expenses. This was partially offset by lower spending on cadisegliatin, primarily due to reduced costs in toxicity studies and drug manufacturing, countered by increased clinical trial start-up costs.
  • General & Administrative (G&A) Expenses: G&A expenses were $3.3 million and $2.5 million for each of the three months ended September 30, 2024, and 2023, respectively. The increase was primarily due to increases in share-based expense, legal expense and higher payroll costs.
  • Other Income (Expense), Net: Other income for the three months ended September 30, 2024, was $0.2 million and was driven by gains related to the change in the fair value of the warrants to purchase shares of our own stock. Other expense for the three months ended September 30, 2023, was $3.3 million and was driven by an impairment charge on a cost-method investment. This was partially offset by an unrealized gain from the Company’s investment in OnKure and gains from changes in the fair value of warrants to purchase shares of our own stock issued to related parties.
  • Net Loss: Net loss attributable to vTv shareholders for the three months ended September 30, 2024, was $4.8 million or $0.88 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $6.7 million or $3.19 per basic share.


vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
    
 September 30,
2024
 December 31,
2023
 (Unaudited)  
Assets   
Current assets:   
Cash and cash equivalents$41,571  $9,446 
Accounts receivable 242   102 
Prepaid expenses and other current assets 1,060   1,044 
Current deposits 85   65 
Total current assets 42,958   10,657 
Property and equipment, net 50   117 
Operating lease right-of-use assets 156   244 
Total assets$43,164  $11,018 
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity (Deficit)   
Current liabilities:   
Accounts payable and accrued expenses$6,226  $10,242 
Current portion of operating lease liabilities 181   169 
Current portion of contract liabilities 17   17 
Current portion of notes payable    191 
Total current liabilities 6,424   10,619 
Contract liabilities, net of current portion 18,669   18,669 
Operating lease liabilities, net of current portion 32   169 
Warrant liability, related party 82   110 
Warrant liability 44    
Total liabilities 25,251   29,567 
Commitments and contingencies   
Redeemable noncontrolling interest    6,131 
Stockholders’ equity (deficit):   
Class A Common Stock 26   21 
Class B Common Stock 6   6 
Additional paid-in capital 311,060   256,335 
Accumulated deficit (296,084)  (281,042)
Total stockholders’ equity (deficit) attributable to vTv Therapeutics Inc. 15,008   (24,680)
Noncontrolling interest 2,905    
Total stockholders’ equity (deficit) 17,913   (24,680)
Total liabilities, redeemable noncontrolling interest and stockholders’ equity (deficit)$43,164  $11,018 
        


 vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
    
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024  2023(*)  2024  2023(*)
 (Unaudited) (Unaudited)
Revenue$  $  $1,000  $ 
Operating expenses:       
Research and development 3,224   2,824   9,312   11,457 
General and administrative 3,282   2,544   10,976   9,338 
Total operating expenses 6,506   5,368   20,288   20,795 
Operating loss (6,506)  (5,368)  (19,288)  (20,795)
Interest income 504   131   1,136   384 
Interest expense    (4)     (6)
Other income (expense), net 162   (3,299)  (16)  (1,108)
Loss before income taxes and noncontrolling interest (5,840)  (8,540)  (18,168)  (21,525)
Income tax provision       100    
Net loss before noncontrolling interest (5,840)  (8,540)  (18,268)  (21,525)
Less: net loss attributable to noncontrolling interest (1,057)  (1,886)  (3,440)  (4,753)
Net loss attributable to vTv Therapeutics Inc.$(4,783) $(6,654) $(14,828) $(16,772)
Net loss attributable to vTv Therapeutics Inc. common shareholders$(4,783) $(6,654) $(14,828) $(16,772)
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted$(0.88) $(3.19) $(2.70) $(8.04)
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted 5,456,307   2,084,973   5,498,479   2,084,973 
(*) Adjusted retroactively for reverse stock split       
        

About vTv Therapeutics

vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv's clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are investigating additional indications including type 2 diabetes and other chronic conditions.

Forward-Looking Statement

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 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 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 our forward-looking statements by these cautionary statements.

Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com


FAQ

What were vTv Therapeutics' Q3 2024 financial results?

vTv Therapeutics reported a net loss of $4.8 million or $0.88 per share for Q3 2024.

What is the cash position of vTv Therapeutics as of September 30, 2024?

The cash position was $41.6 million as of September 30, 2024.

Why did vTv Therapeutics' R&D expenses increase in Q3 2024?

R&D expenses increased due to higher indirect costs and other project-related expenses.

What caused the increase in G&A expenses for vTv Therapeutics in Q3 2024?

The increase in G&A expenses was driven by higher share-based, legal, and payroll costs.

What is the status of the cadisegliatin program?

The cadisegliatin program is under FDA clinical hold, but discussions are ongoing.

vTv Therapeutics Inc.

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Biotechnology
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