vTv Therapeutics Announces 2024 Fourth Quarter and Full Year Financial Results and Provides Corporate Update
vTv Therapeutics (VTVT) reported its Q4 and full-year 2024 financial results, highlighting the FDA's lifting of the clinical hold on its cadisegliatin program in March 2025. The company plans to resume its Phase 3 CATT1 trial for type 1 diabetes in Q2 2025, with a protocol amendment reducing trial duration from 12 to 6 months.
Financial highlights include a cash position of $36.7 million as of December 31, 2024, up from $9.4 million year-over-year. Q4 2024 net loss was $3.6 million ($0.55 per share), compared to $3.5 million ($1.67 per share) in Q4 2023. Full-year 2024 net loss decreased to $18.5 million ($3.20 per share) from $20.3 million in 2023.
The company strengthened its commercial leadership by appointing Martin Lafontaine as Chief Commercial Officer, bringing 27 years of pharmaceutical and medical device industry experience.
vTv Therapeutics (VTVT) ha riportato i risultati finanziari del Q4 e dell'intero anno 2024, evidenziando la revoca da parte della FDA della sospensione clinica sul suo programma di cadisegliatina a marzo 2025. L'azienda prevede di riprendere il suo trial di Fase 3 CATT1 per il diabete di tipo 1 nel Q2 2025, con una modifica del protocollo che riduce la durata del trial da 12 a 6 mesi.
I punti salienti finanziari includono una posizione di cassa di 36,7 milioni di dollari al 31 dicembre 2024, in aumento rispetto ai 9,4 milioni di dollari dell'anno precedente. La perdita netta del Q4 2024 è stata di 3,6 milioni di dollari (0,55 dollari per azione), rispetto ai 3,5 milioni di dollari (1,67 dollari per azione) del Q4 2023. La perdita netta dell'intero anno 2024 è diminuita a 18,5 milioni di dollari (3,20 dollari per azione) rispetto ai 20,3 milioni di dollari del 2023.
L'azienda ha rafforzato la sua leadership commerciale nominando Martin Lafontaine come Chief Commercial Officer, portando con sé 27 anni di esperienza nell'industria farmaceutica e dei dispositivi medici.
vTv Therapeutics (VTVT) informó sobre sus resultados financieros del cuarto trimestre y del año completo 2024, destacando el levantamiento de la retención clínica por parte de la FDA en su programa de cadisegliatina en marzo de 2025. La compañía planea reanudar su ensayo de Fase 3 CATT1 para la diabetes tipo 1 en el segundo trimestre de 2025, con una enmienda al protocolo que reduce la duración del ensayo de 12 a 6 meses.
Los aspectos financieros destacados incluyen una posición de efectivo de $36.7 millones al 31 de diciembre de 2024, un aumento desde los $9.4 millones del año anterior. La pérdida neta del cuarto trimestre de 2024 fue de $3.6 millones ($0.55 por acción), en comparación con $3.5 millones ($1.67 por acción) en el cuarto trimestre de 2023. La pérdida neta del año completo 2024 disminuyó a $18.5 millones ($3.20 por acción) desde $20.3 millones en 2023.
La compañía fortaleció su liderazgo comercial al nombrar a Martin Lafontaine como Director Comercial, aportando 27 años de experiencia en la industria farmacéutica y de dispositivos médicos.
vTv Therapeutics (VTVT)는 2024년 4분기 및 전체 연도 재무 결과를 발표하며, 2025년 3월 FDA가 자사 카디세글리아틴 프로그램에 대한 임상 보류를 해제한 사실을 강조했습니다. 회사는 2025년 2분기에 제1형 당뇨병에 대한 3상 CATT1 시험을 재개할 계획이며, 시험 기간을 12개월에서 6개월로 줄이는 프로토콜 수정이 포함됩니다.
재무 하이라이트에는 2024년 12월 31일 기준 3670만 달러의 현금 보유가 포함되어 있으며, 이는 작년의 940만 달러에서 증가한 수치입니다. 2024년 4분기 순손실은 360만 달러(주당 0.55달러)로, 2023년 4분기의 350만 달러(주당 1.67달러)와 비교됩니다. 2024년 전체 연도 순손실은 1830만 달러(주당 3.20달러)로, 2023년의 2030만 달러에서 감소했습니다.
회사는 27년의 제약 및 의료기기 산업 경험을 가진 Martin Lafontaine을 최고 상업 책임자로 임명하여 상업적 리더십을 강화했습니다.
vTv Therapeutics (VTVT) a annoncé ses résultats financiers du quatrième trimestre et de l'année entière 2024, mettant en avant la levée par la FDA de la suspension clinique de son programme de cadisegliatine en mars 2025. L'entreprise prévoit de reprendre son essai de Phase 3 CATT1 pour le diabète de type 1 au deuxième trimestre 2025, avec un amendement au protocole réduisant la durée de l'essai de 12 à 6 mois.
Les points forts financiers comprennent une position de trésorerie de 36,7 millions de dollars au 31 décembre 2024, en hausse par rapport à 9,4 millions de dollars l'année précédente. La perte nette au quatrième trimestre 2024 était de 3,6 millions de dollars (0,55 dollar par action), contre 3,5 millions de dollars (1,67 dollar par action) au quatrième trimestre 2023. La perte nette pour l'année entière 2024 a diminué à 18,5 millions de dollars (3,20 dollars par action) contre 20,3 millions de dollars en 2023.
L'entreprise a renforcé son leadership commercial en nommant Martin Lafontaine au poste de directeur commercial, apportant avec lui 27 ans d'expérience dans l'industrie pharmaceutique et des dispositifs médicaux.
vTv Therapeutics (VTVT) hat seine Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei die Aufhebung der klinischen Sperre durch die FDA für sein Cadisegliatin-Programm im März 2025 hervorgehoben. Das Unternehmen plant, im 2. Quartal 2025 die Phase 3 CATT1-Studie für Typ-1-Diabetes wieder aufzunehmen, mit einer Protokolländerung, die die Studiendauer von 12 auf 6 Monate verkürzt.
Zu den finanziellen Höhepunkten gehört eine Liquiditätsposition von 36,7 Millionen US-Dollar zum 31. Dezember 2024, ein Anstieg von 9,4 Millionen US-Dollar im Jahresvergleich. Der Nettoverlust im 4. Quartal 2024 betrug 3,6 Millionen US-Dollar (0,55 US-Dollar pro Aktie), verglichen mit 3,5 Millionen US-Dollar (1,67 US-Dollar pro Aktie) im 4. Quartal 2023. Der Nettoverlust für das gesamte Jahr 2024 sank auf 18,5 Millionen US-Dollar (3,20 US-Dollar pro Aktie) von 20,3 Millionen US-Dollar im Jahr 2023.
Das Unternehmen stärkte seine kommerzielle Führung, indem es Martin Lafontaine zum Chief Commercial Officer ernannte, der 27 Jahre Erfahrung in der Pharma- und Medizintechnikbranche mitbringt.
- FDA lifted clinical hold on cadisegliatin program, allowing Phase 3 trial resumption
- Cash position significantly improved to $36.7M from $9.4M year-over-year
- Reduced trial duration from 12 to 6 months accelerates time to topline data
- Full-year net loss improved to $18.5M from $20.3M in previous year
- R&D expenses decreased by $2.1M year-over-year
- Q4 2024 net loss increased to $3.6M from $3.5M year-over-year
- G&A expenses increased by $1.7M to $13.7M in 2024
- Clinical trial delays due to previous FDA hold impact development timeline
Insights
The lifting of the FDA clinical hold on cadisegliatin represents a significant de-risking event for vTv Therapeutics. With Phase 3 CATT1 trials expected to resume in Q2 2025, the company has strategically amended the protocol to shorten trial duration from 12 to 6 months, which will accelerate time to topline data without compromising key endpoints.
The company's financial position has strengthened substantially, with cash increasing nearly fourfold from
While the company continues to operate at a loss (
The appointment of Martin Lafontaine as CCO signals vTv's forward-looking preparation for commercialization. His experience with Nasal Glucagon at Locemia (later sold to Eli Lilly) brings relevant diabetes commercialization expertise as the company advances its potentially first-in-class oral adjunctive therapy for type 1 diabetes toward potential approval.
Clinical hold lifted for late stage cadisegliatin program for diabetes
CATT1 Phase 3 trial in patients with type 1 diabetes (T1D) expected to resume Q2 2025
Strengthens commercial leadership with appointment of Martin Lafontaine as Chief Commercial Officer
HIGH POINT, N.C., March 20, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today reported financial results for the fourth quarter and year ended December 31, 2024, and provided an update on recent corporate developments.
“We are thrilled our cadisegliatin clinical program can resume following the lifting of the clinical hold by the U.S. Food and Drug Administration (FDA). We expect to resume our Phase 3 CATT1 trial in patients with T1D in the second quarter of 2025 following submission of a protocol amendment shortening the trial duration from 12 to 6 months,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Importantly, this amendment accelerates the time to topline data and allows initiation of our required pivotal studies sooner by forgoing an additional 6-month safety assessment with no impact on the original key endpoints of the study.”
Mr. Sekhri continued, “As we approach our next stage of growth, we are pleased to have strengthened our commercial leadership with the appointment of Martin Lafontaine as our Chief Commercial Officer. Martin brings a wealth of commercial experience in diabetes which will position us for success as we prepare to further progress across our registrational program for cadisegliatin.”
Recent Company Highlights
- Clinical Hold Lifted for Cadisegliatin Program. In March 2025, vTv Therapeutics announced that the clinical hold placed by the FDA in July 2024 on the cadisegliatin clinical program was lifted on March 14, 2025, following the Company’s submission of a complete response letter. The CATT1 Phase 3 trial is expected to resume in Q2 2025.
- Planned Submission of CATT1 Phase 3 Trial Protocol Amended. The Company plans to amend the protocol for the CATT1 Phase 3 trial in patients with T1D to reduce the duration of the trial from twelve months to six months by forgoing an additional 6-month safety assessment with no impact on the original key endpoints of the study.
- Strengthened Commercial Leadership. Today, vTv Therapeutics announced that Martin Lafontaine has joined the Company as Chief Commercial Officer (CCO) to advance late stage cadisegliatin program. A seasoned executive, Mr. Lafontaine brings over 27 years of commercial experience within the pharmaceutical and medical device industry. He has also served as a consultant of vTv Therapeutics since 2023. Before joining vTv, he held commercial leadership positions in the field of diabetes including chief commercial officer at Locemia Solutions Inc., where he played an instrumental role in the development and sale of the Nasal Glucagon asset to Eli Lilly and Company in 2015. Mr. Lafontaine received a B.S. from L’Université du Québec à Trois-Rivières.
Fourth Quarter 2024 Financial Results
- Cash Position: The Company’s cash position as of December 31, 2024, was
$36.7 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. - Research & Development (R&D) Expenses: R&D expenses were
$2.2 million and$2.1 million in each of the three months ended December 31, 2024, and 2023, respectively. The increase is attributable to (i) higher indirect costs of$0.7 million , partially offset by (ii) lower spending on cadisegliatin and other projects of$0.6 million , primarily due to reduced costs in drug manufacturing and other clinical trial costs. - General & Administrative (G&A) Expenses: G&A expenses were
$2.7 million and$2.6 million for each of the three months ended December 31, 2024, and 2023, respectively. The increase of$0.1 million was primarily due to (i) an increase in share-based expense of$0.3 million , (ii) an increase in legal expense of$0.1 million , partially offset by (iii) a decrease in other operating costs of$0.3 million . - Interest Income: Interest income for the three months ended December 31, 2024, was
$0.4 million is related to interest and dividend income from our money market account. Interest income for the three months ended December 31, 2023, was immaterial. - Other Income (Expense), net: Other income for the three months ended December 31, 2024, was immaterial. 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”). - Net Loss: Net loss attributable to vTv shareholders for the three months ended December 31, 2024, was
$3.6 million or$0.55 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was$3.5 million or$1.67 per basic share.
Full Year 2024 Financial Results
- Research & Development (R&D) Expenses: R&D expenses were
$11.5 million and$13.6 million in each of the years ended December 31, 2024, and 2023, respectively. The decrease is attributable to (i) lower spending on cadisegliatin of$4.2 million , due to decreases in toxicity studies, clinical pharmaceutical studies and other clinical trial costs, drug manufacturing costs and ii) other projects of$0.2 million , partially offset by iii) an increase in indirect costs of$2.2 million due to increases in payroll and bonus costs. - General & Administrative (G&A) Expenses: G&A expenses were
$13.7 million and$11.9 million for each of the years ended December 31, 2024, and 2023, respectively. The increase of$1.7 million was due to (i) an increase in payroll costs of$1.0 million , ii) an increased in share-based expense of$0.8 million , iii) an increase in other operating costs of$0.1 million , partially offset by iv) a decrease of$0.2 million in legal expenses. - Interest Income: Interest income for the year ended December 31, 2024 of
$1.6 million is related to interest and dividend income from our money market account. Interest income for the year ended December 31, 2023 of$0.5 million is related to the imputed interest on the G42 Promissory Note and dividend income from our money market account. - Other Income (Expense), net: Other expense was immaterial for the year ended December 31, 2024. 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 of$4.2 million offset by a realized gain of$3.1 million related to the Company’s Repurchase Agreement with Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our Class A common stock issued to related parties. - Net Loss: Net loss attributable to vTv shareholders for the year ended December 31, 2024, was
$18.5 million or$3.20 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was$20.3 million or$9.71 per basic share.
vTv Therapeutics Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
December 31, 2024 | December 31, 2023 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 36,746 | $ | 9,446 | |||
Accounts receivable, net | 62 | 102 | |||||
Prepaid expenses and other current assets | 1,220 | 1,044 | |||||
Current deposits | 85 | 65 | |||||
Total current assets | 38,113 | 10,657 | |||||
Property and equipment, net | 28 | 117 | |||||
Operating lease right-of-use assets | 125 | 244 | |||||
Long-term investments | — | — | |||||
Total assets | $ | 38,266 | $ | 11,018 | |||
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity (Deficit) | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 5,027 | $ | 10,242 | |||
Current portion of operating lease liabilities | 169 | 169 | |||||
Current portion of contract liabilities | — | 17 | |||||
Current portion of notes payable | — | 191 | |||||
Total current liabilities | 5,196 | 10,619 | |||||
Contract liabilities, net of current portion | 18,669 | 18,669 | |||||
Operating lease liabilities, net of current portion | — | 169 | |||||
Warrant liability, related party | 57 | 110 | |||||
Warrant liability | 43 | — | |||||
Total liabilities | 23,965 | 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 | 311,885 | 256,335 | |||||
Accumulated deficit | (299,718 | ) | (281,042 | ) | |||
Total stockholders’ equity (deficit) attributable to vTv Therapeutics Inc. | 12,199 | (24,680 | ) | ||||
Noncontrolling interest | 2,102 | — | |||||
Total stockholders’ equity (deficit) | 14,301 | (24,680 | ) | ||||
Total liabilities, redeemable noncontrolling interest and stockholders’ equity (deficit) | $ | 38,266 | $ | 11,018 | |||
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, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
(Unaudited) | |||||||||||||||
Revenue | $ | 17 | $ | — | $ | 1,017 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 2,234 | 2,138 | 11,546 | 13,595 | |||||||||||
General and administrative | 2,675 | 2,569 | 13,651 | 11,907 | |||||||||||
Total operating expenses | 4,909 | 4,707 | 25,197 | 25,502 | |||||||||||
Operating loss | (4,892 | ) | (4,707 | ) | (24,180 | ) | (25,502 | ) | |||||||
Interest income | 429 | 88 | 1,565 | 472 | |||||||||||
Interest expense | — | (7 | ) | — | (13 | ) | |||||||||
Other income (expense), net | 26 | 185 | 10 | (923 | ) | ||||||||||
Loss before income taxes | (4,437 | ) | (4,441 | ) | (22,605 | ) | (25,966 | ) | |||||||
Income tax provision | — | — | 100 | — | |||||||||||
Net loss before noncontrolling interest | (4,437 | ) | (4,441 | ) | (22,705 | ) | (25,966 | ) | |||||||
Less: Net loss attributable to noncontrolling interest | (803 | ) | (963 | ) | (4,243 | ) | (5,716 | ) | |||||||
Net loss attributable to vTv Therapeutics Inc. | $ | (3,634 | ) | $ | (3,478 | ) | $ | (18,462 | ) | $ | (20,250 | ) | |||
Net loss attributable to vTv Therapeutics Inc. common shareholders | $ | (3,634 | ) | $ | (3,478 | ) | $ | (18,462 | ) | $ | (20,250 | ) | |||
Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted | $ | (0.55 | ) | $ | (1.67 | ) | $ | (3.20 | ) | $ | (9.71 | ) | |||
Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted | 6,582,844 | 2,084,973 | 5,771,052 | 2,084,973 | |||||||||||
About vTv Therapeutics
Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D). In nonclinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage.
Cadisegliatin is under investigation and the 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.
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.
Contacts:
Sandya von der Weid
LifeSci Advisors, LLC
svonderweid@lifesciadvisors.com
