Nuvation Bio Reports Third Quarter 2024 Financial Results and Provides Business Update
Nuvation Bio (NYSE: NUVB) reported Q3 2024 financial results and business updates. Key highlights include the submission of a New Drug Application for taletrectinib to the FDA for ROS1-positive NSCLC treatment, with potential commercialization by mid-2025. The company presented positive pooled data showing 89% response rate in TKI-naïve patients. Financial results show cash position of $549.1 million, with increased R&D expenses of $27.7 million and G&A expenses of $19.6 million. The quarter ended with a net loss of $41.2 million, or ($0.15) per share, compared to $19.6 million loss in Q3 2023.
Nuvation Bio (NYSE: NUVB) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono la presentazione di una Domanda di Nuovo Farmaco per taletrectinib all'FDA per il trattamento del NSCLC positivo al ROS1, con una possibile commercializzazione entro metà del 2025. L'azienda ha presentato dati aggregati positivi che mostrano un tasso di risposta dell'89% nei pazienti naïve ai TKI. I risultati finanziari indicano una posizione di cassa di 549,1 milioni di dollari, con spese di R&S aumentate a 27,7 milioni di dollari e spese generali e amministrative pari a 19,6 milioni di dollari. Il trimestre si è chiuso con una perdita netta di 41,2 milioni di dollari, ovvero ($0,15) per azione, rispetto a una perdita di 19,6 milioni di dollari nel terzo trimestre 2023.
Nuvation Bio (NYSE: NUVB) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones de negocio. Los aspectos destacados incluyen la presentación de una Solicitud de Nuevo Medicamento para taletrectinib ante la FDA para el tratamiento del NSCLC positivo para ROS1, con una posible comercialización para mediados de 2025. La empresa presentó datos agrupados positivos que muestran una tasa de respuesta del 89% en pacientes naïve a TKI. Los resultados financieros muestran una posición de efectivo de 549.1 millones de dólares, con un aumento en los gastos de I+D de 27.7 millones de dólares y gastos generales y administrativos de 19.6 millones de dólares. El trimestre terminó con una pérdida neta de 41.2 millones de dólares, o ($0.15) por acción, en comparación con una pérdida de 19.6 millones de dólares en el tercer trimestre de 2023.
Nuvation Bio (NYSE: NUVB)는 2024년 3분기 재무 결과 및 사업 업데이트를 발표했습니다. 주요 하이라이트에는 ROS1 양성 비소세포 폐암(NSCLC) 치료를 위한 taletrectinib의 신약 신청서 제출이 포함되며, 2025년 중반에 상용화될 가능성이 있습니다. 이 회사는 TKI-naïve 환자에서 89%의 반응률을 보여주는 긍정적인 집계 데이터를 발표했습니다. 재무 결과는 549.1백만 달러의 현금 보유액을 보여주며, R&D 비용은 27.7백만 달러, 일반 및 관리 비용은 19.6백만 달러로 증가했습니다. 분기는 41.2백만 달러의 순손실로 마감했으며, 주당 ($0.15)로, 2023년 3분기 손실 19.6백만 달러와 비교되었습니다.
Nuvation Bio (NYSE: NUVB) a annoncé les résultats financiers du troisième trimestre 2024 et les mises à jour de l'entreprise. Les points clés incluent la soumission d'une Demande de Nouveau Médicament pour taletrectinib à la FDA pour le traitement du NSCLC positif au ROS1, avec une commercialisation potentielle d'ici mi-2025. L'entreprise a présenté des données agrégées positives montrant un taux de réponse de 89% chez les patients naïfs aux TKI. Les résultats financiers montrent une position de trésorerie de 549,1 millions de dollars, avec des dépenses en R&D augmentées à 27,7 millions de dollars et des dépenses générales et administratives de 19,6 millions de dollars. Le trimestre s'est terminé avec une perte nette de 41,2 millions de dollars, soit ($0,15) par action, par rapport à une perte de 19,6 millions de dollars au troisième trimestre 2023.
Nuvation Bio (NYSE: NUVB) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Unternehmensupdates veröffentlicht. Zu den wichtigsten Punkten gehört die Einreichung eines Antrags auf ein neues Medikament für taletrectinib bei der FDA zur Behandlung von ROS1-positivem NSCLC, mit einer potenziellen Vermarktung bis Mitte 2025. Das Unternehmen präsentierte positive aggregierte Daten, die eine Ansprechrate von 89% bei TKI-naïven Patienten zeigen. Die finanziellen Ergebnisse weisen auf eine Barmittelposition von 549,1 Millionen Dollar hin, mit gestiegenen F&E-Ausgaben von 27,7 Millionen Dollar und allgemeinen sowie Verwaltungskosten von 19,6 Millionen Dollar. Das Quartal endete mit einem Nettoverlust von 41,2 Millionen Dollar, das entspricht ($0,15) pro Aktie, im Vergleich zu einem Verlust von 19,6 Millionen Dollar im dritten Quartal 2023.
- Strong cash position of $549.1 million as of September 30, 2024
- 89% confirmed objective response rate for taletrectinib in TKI-naïve patients
- 44-month median duration of response in TKI-naïve patients
- Low treatment discontinuation rate of 7% for taletrectinib
- Net loss increased to $41.2 million from $19.6 million year-over-year
- R&D expenses increased 49.7% to $27.7 million year-over-year
- G&A expenses increased 151% to $19.6 million year-over-year
Insights
The Q3 results show significant operational expansion with
The increased spending reflects strategic investments in taletrectinib's commercialization preparations and expanded clinical programs. While losses have widened, this is expected given the company's transition toward potential commercial operations by mid-2025. The robust cash position should adequately support operations through key milestones, including the potential FDA approval of taletrectinib.
The NDA submission for taletrectinib represents a significant milestone, supported by impressive clinical data. The
The drug's favorable safety profile, with only
Submitted New Drug Application (NDA) for taletrectinib to the
Presented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1+ NSCLC at the 2024 European Society of Medical Oncology (ESMO) Congress
Appointed industry veteran Philippe Sauvage as the company’s Chief Financial Officer (CFO) in October
Strong balance sheet with cash, cash equivalents, and marketable securities of
David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, reflected on the quarter and stated: “In the third quarter, we continued to execute on our goal of bringing taletrectinib to people living with ROS1-positive NSCLC as quickly as possible, which has been our focus since we closed the acquisition of AnHeart Therapeutics earlier this year. In October, we completed the rolling submission of our NDA for line agnostic full approval of taletrectinib in advanced ROS1-positive NSCLC, which was supported by the pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies that we presented at ESMO. We believe that these data – a confirmed objective response rate of
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC
-
Completed submission of an NDA for taletrectinib to the
U.S. FDA for the treatment of advanced ROS1+ NSCLC (line agnostic) in October, in alignment with feedback from theU.S. FDA as part of a pre-NDA meeting.-
Company expects the
U.S. FDA to accept its NDA submission for full approval as early as year-end 2024, which, if approved, will allow Nuvation Bio to launch taletrectinib in theU.S. as early as mid-2025. -
Taletrectinib is the only ROS1 tyrosine kinase inhibitor (TKI) currently in development that has received Breakthrough Therapy Designation from the
U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs (line agnostic).
-
Company expects the
- Pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies were presented at the 2024 ESMO Congress in September. The pooled analysis supported the Company’s NDA submission for taletrectinib.
-
Key highlights from the pooled analysis include:
-
Confirmed objective responses in
89% of taletrectinib-treated patients with advanced ROS1+ NSCLC who were tyrosine kinase inhibitor (TKI)-naïve and56% of those who were TKI-pretreated in the study. - Taletrectinib demonstrated durable responses and prolonged disease control with long-term follow up; median duration of response (DOR) and median progression-free survival (PFS) in TKI-naïve patients were 44 months and 46 months, respectively.
-
Taletrectinib’s safety and tolerability profile appeared favorable, including a low treatment discontinuation rate of
7% .
-
Confirmed objective responses in
- Data from the global, pivotal Phase 2 TRUST-II study were presented at the 2024 World Conference on Lung Cancer in September as part of the press program.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
- Safusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.
- Phase 2 study of safusidenib in patients with diffuse IDH1-mutant glioma remains ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
- NUV-1511, the Company’s first clinical-stage DDC, fuses a targeting agent to a widely used chemotherapy agent.
- Phase 1/2 dose escalation study of NUV-1511 in patients with various advanced solid tumors remains ongoing.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors
- As previously announced, the Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
Corporate Updates:
- Appointed Philippe Sauvage as Chief Financial Officer in October. Mr. Sauvage brings over 20 years of global leadership experience in finance, operations, and commercialization within healthcare and biopharmaceutical organizations.
- Appointed David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, as Chairman of the Board of Directors. Additionally, the Company appointed Robert Bazemore as lead independent director.
Third Quarter 2024 Financial Results
As of September 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of
For the three months ended September 30, 2024, research and development expenses were
For the three months ended September 30, 2024, general and administrative expenses were
For the three months ended September 30, 2024, Nuvation Bio reported a net loss of
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in
Taletrectinib has been granted Orphan Drug Designation by the
About Nuvation Bio
Nuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding FDA acceptance, the length of the review period, and full approval of a
| NUVATION BIO INC. and Subsidiaries | ||||||||
| Consolidated Balance Sheets | ||||||||
| Unaudited | ||||||||
| (In thousands, except share and per share data) | September 30, |
|
December 31, |
|||||
|
2024 |
|
|
|
2023 |
|
||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
30,036 |
|
$ |
42,649 |
|
||
| Accounts receivable, net of allowance for credit loss of $nil |
|
112 |
|
|
- |
|
||
| Prepaid expenses and other current assets |
|
11,598 |
|
|
1,519 |
|
||
| Marketable securities |
|
519,099 |
|
|
568,564 |
|
||
| Interest receivable on marketable securities |
|
4,140 |
|
|
3,702 |
|
||
| Total current assets |
|
564,985 |
|
|
616,434 |
|
||
| Property and equipment, net of accumulated depreciation of |
|
719 |
|
|
717 |
|
||
| Intangible assets, net of accumulated amortization of |
|
2,779 |
|
|
- |
|
||
| Operating lease right-of-use assets |
|
2,472 |
|
|
3,605 |
|
||
| Lease security deposit |
|
144 |
|
|
141 |
|
||
| Other non-current assets |
|
480 |
|
|
587 |
|
||
| Total assets | $ |
571,579 |
|
$ |
621,484 |
|
||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
12,380 |
|
$ |
2,209 |
|
||
| Current operating lease liabilities |
|
1,781 |
|
|
1,972 |
|
||
| Contract liabilities, current portion |
|
12,942 |
|
|
- |
|
||
| Short-term borrowings |
|
8,426 |
|
|
- |
|
||
| Accrued expenses |
|
23,506 |
|
|
9,793 |
|
||
| Total current liabilities |
|
59,035 |
|
|
13,974 |
|
||
| Warrant liability |
|
908 |
|
|
353 |
|
||
| Contract liabilities, net of current portion |
|
7,937 |
|
|
- |
|
||
| Non-current operating lease liabilities |
|
985 |
|
|
2,035 |
|
||
| Total liabilities |
|
68,865 |
|
|
16,362 |
|
||
| Stockholders' equity | ||||||||
| Class A and Class B common stock and additional paid in capital, |
|
1,362,631 |
|
|
947,745 |
|
||
| Accumulated deficit |
|
(861,298 |
) |
|
(342,804 |
) |
||
| Accumulated other comprehensive income |
|
1,381 |
|
|
181 |
|
||
| Total stockholders' equity |
|
502,714 |
|
|
605,122 |
|
||
| Total liabilities and stockholders' equity | $ |
571,579 |
|
$ |
621,484 |
|
||
| NUVATION BIO INC. and Subsidiaries | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||||
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
||
| Revenue | $ |
727 |
|
$ |
- |
|
$ |
2,162 |
|
$ |
- |
|
||||
| Cost of revenue |
|
1,515 |
|
|
- |
|
|
2,862 |
|
|
- |
|
||||
| Gross deficit |
|
(788 |
) |
|
- |
|
|
(700 |
) |
|
- |
|
||||
| Operating expenses: | ||||||||||||||||
| Research and development |
|
27,731 |
|
|
18,561 |
|
|
69,820 |
|
|
55,938 |
|
||||
| Acquired in-process research and development |
|
- |
|
|
- |
|
|
425,070 |
|
|
- |
|
||||
| General and administrative |
|
19,582 |
|
|
7,778 |
|
|
43,095 |
|
|
23,053 |
|
||||
| Total operating expenses |
|
47,313 |
|
|
26,339 |
|
|
537,985 |
|
|
78,991 |
|
||||
| Loss from operations |
|
(48,101 |
) |
|
(26,339 |
) |
|
(538,685 |
) |
|
(78,991 |
) |
||||
| Other income (expense): | ||||||||||||||||
| Interest income |
|
6,726 |
|
|
6,523 |
|
|
21,000 |
|
|
17,588 |
|
||||
| Interest expense |
|
(120 |
) |
|
- |
|
|
(252 |
) |
|
- |
|
||||
| Investment advisory fees |
|
(237 |
) |
|
(228 |
) |
|
(749 |
) |
|
(689 |
) |
||||
| Change in fair value of warrant liability |
|
533 |
|
|
383 |
|
|
209 |
|
|
260 |
|
||||
| Realized (loss) gain on marketable securities |
|
(11 |
) |
|
12 |
|
|
(17 |
) |
|
(183 |
) |
||||
| Total other income (expense), net |
|
6,891 |
|
|
6,690 |
|
|
20,191 |
|
|
16,976 |
|
||||
| Loss before income taxes |
|
(41,210 |
) |
|
(19,649 |
) |
|
(518,494 |
) |
|
(62,015 |
) |
||||
| Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
||||
| Net loss | $ |
(41,210 |
) |
$ |
(19,649 |
) |
$ |
(518,494 |
) |
$ |
(62,015 |
) |
||||
| Net loss attributable to common stockholders | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ |
(0.15 |
) |
$ |
(0.09 |
) |
$ |
(2.11 |
) |
$ |
(0.28 |
) |
||||
| Weighted average common shares outstanding, basic and diluted |
|
273,565 |
|
|
218,935 |
|
|
245,885 |
|
|
218,842 |
|
||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ |
(41,210 |
) |
$ |
(19,649 |
) |
$ |
(518,494 |
) |
$ |
(62,015 |
) |
||||
| Other comprehensive loss, net of taxes: | ||||||||||||||||
| Currency translation adjustment |
|
(742 |
) |
|
- |
|
|
(594 |
) |
|
- |
|
||||
| Unrealized gain on available-for-sale securities |
|
3,389 |
|
|
1,097 |
|
|
1,794 |
|
|
2,228 |
|
||||
| Comprehensive loss | $ |
(38,563 |
) |
$ |
(18,552 |
) |
$ |
(517,294 |
) |
$ |
(59,787 |
) |
||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241106502244/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
media@nuvationbio.com
Source: Nuvation Bio Inc.
FAQ
What were Nuvation Bio's (NUVB) Q3 2024 financial results?
What were the clinical results for NUVB's taletrectinib in ROS1+ NSCLC?
When does Nuvation Bio (NUVB) expect potential FDA approval for taletrectinib?
