Nuvation Bio Reports Second Quarter 2024 Financial Results and Provides Business Update
Nuvation Bio (NYSE: NUVB) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Efficacy and safety data from the Phase 2 TRUST-I study of taletrectinib published in the Journal of Clinical Oncology and presented at ASCO 2024
- Pooled data from TRUST-I and TRUST-II studies to be presented at ESMO 2024, supporting planned NDA filing
- Taletrectinib granted Orphan Drug Designation by FDA for ROS1-positive NSCLC
- Strong balance sheet with $577.2 million in cash and equivalents as of June 30, 2024
- Q2 2024 net loss of $462.5 million, or $(1.89) per share, compared to $20.6 million in Q2 2023
- R&D expenses increased to $29.2 million, up from $18.6 million in Q2 2023
Nuvation Bio (NYSE: NUVB) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
- Dati di efficacia e sicurezza dallo studio TRUST-I di fase 2 su taletrectinib pubblicati nel Journal of Clinical Oncology e presentati ad ASCO 2024
- Dati aggregati dagli studi TRUST-I e TRUST-II saranno presentati a ESMO 2024, a sostegno della prevista presentazione della NDA
- Taletrectinib ha ricevuto la Designazione di Farmaco Orfano da parte della FDA per NSCLC positivo al ROS1
- Oneroso bilancio con 577,2 milioni di dollari in contante e equivalenti al 30 giugno 2024
- Perdita netta del secondo trimestre 2024 di 462,5 milioni di dollari, pari a $(1,89) per azione, rispetto ai 20,6 milioni di dollari del secondo trimestre 2023
- Le spese per R&S sono aumentate a 29,2 milioni di dollari, rispetto ai 18,6 milioni di dollari del secondo trimestre 2023
Nuvation Bio (NYSE: NUVB) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización comercial. Los aspectos destacados incluyen:
- Datos de eficacia y seguridad del estudio TRUST-I de fase 2 de taletrectinib publicados en el Journal of Clinical Oncology y presentados en ASCO 2024
- Datos agrupados de los estudios TRUST-I y TRUST-II que se presentarán en ESMO 2024, apoyando la presentación prevista de la NDA
- Taletrectinib recibió la Designación de Medicamento Huérfano por parte de la FDA para NSCLC positivo para ROS1
- Fuerte balance general con $577.2 millones en efectivo y equivalentes a partir del 30 de junio de 2024
- Pérdida neta del segundo trimestre de 2024 de $462.5 millones, o $(1.89) por acción, en comparación con $20.6 millones en el segundo trimestre de 2023
- Los gastos de I+D aumentaron a $29.2 millones, en comparación con $18.6 millones en el segundo trimestre de 2023
Nuvation Bio (NYSE: NUVB)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
- 2상 TRUST-I 연구의 타레트렉티닙 효능 및 안전성 데이터가 Journal of Clinical Oncology에 발표되었고 ASCO 2024에서 발표됨
- TRUST-I 및 TRUST-II 연구의 통합 데이터가 ESMO 2024에서 발표되어 NDA 제출 계획을 지원함
- 타레트렉티닙이 ROS1 양성 비소세포 폐암(NSCLC) 치료를 위해 FDA로부터 오르파인 약물 지정을 받음
- 2024년 6월 30일 기준으로 현금 및 현금성 자산이 5억 7,720만 달러인 강력한 재무 상태
- 2024년 2분기 순손실이 4억 6,250만 달러, 즉 주당 $(1.89)로, 2023년 2분기 2,060만 달러와 비교됨
- R&D 비용이 2023년 2분기 1,860만 달러에서 2,920만 달러로 증가함
Nuvation Bio (NYSE: NUVB) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'activité. Les points saillants comprennent :
- Données d'efficacité et de sécurité de l'étude TRUST-I de phase 2 sur le taletrectinib publiées dans le Journal of Clinical Oncology et présentées à ASCO 2024
- Données regroupées des études TRUST-I et TRUST-II à présenter à ESMO 2024, soutenant le dépôt prévu de la NDA
- Taletrectinib a reçu la désignation de médicament orphelin par la FDA pour le NSCLC positif au ROS1
- Situation financière solide avec 577,2 millions de dollars en liquidités et équivalents au 30 juin 2024
- Perte nette de 462,5 millions de dollars au deuxième trimestre 2024, soit $(1,89) par action, par rapport à 20,6 millions de dollars au deuxième trimestre 2023
- Les dépenses de R&D ont augmenté à 29,2 millions de dollars, contre 18,6 millions de dollars au deuxième trimestre 2023
Nuvation Bio (NYSE: NUVB) hat die finanziellen Ergebnisse des 2. Quartals 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Höhepunkte sind:
- Wirksamkeits- und Sicherheitsdaten aus der Phase 2 TRUST-I-Studie zu Taletrectinib, die im Journal of Clinical Oncology veröffentlicht und auf der ASCO 2024 präsentiert wurden
- Zusammengefasste Daten aus den TRUST-I- und TRUST-II-Studien, die auf der ESMO 2024 präsentiert werden, zur Unterstützung der geplanten NDA-Einreichung
- Taletrectinib erhielt Orphan Drug Designation von der FDA für ROS1-positives NSCLC
- Starkes Bilanz mit 577,2 Millionen Dollar in Bar und Äquivalenten zum 30. Juni 2024
- Nettoverlust im 2. Quartal 2024 von 462,5 Millionen Dollar, oder $(1,89) pro Aktie, im Vergleich zu 20,6 Millionen Dollar im 2. Quartal 2023
- F&E-Ausgaben sind auf 29,2 Millionen Dollar gestiegen, gegenüber 18,6 Millionen Dollar im 2. Quartal 2023
- Taletrectinib granted Orphan Drug Designation by FDA for ROS1-positive NSCLC
- Strong cash position of $577.2 million as of June 30, 2024
- Planned NDA filing for taletrectinib in the U.S., with potential commercialization in 2025
- Progressing global Phase 2 study of safusidenib and Phase 1/2 study of NUV-1511
- Net loss increased significantly to $462.5 million in Q2 2024, compared to $20.6 million in Q2 2023
- R&D expenses increased to $29.2 million, up from $18.6 million in Q2 2023
- G&A expenses more than doubled to $16.1 million, up from $7.5 million in Q2 2023
- Decision not to initiate Phase 2 study of NUV-868 in previously studied solid tumor indications
Insights
Nuvation Bio's Q2 2024 results reveal a mixed financial picture. The company's cash position remains strong at
R&D expenses increased by
The decision to halt NUV-868's Phase 2 study in certain indications demonstrates a strategic focus on more promising assets, potentially improving capital allocation efficiency.
Nuvation Bio's pipeline progress, particularly with taletrectinib, is noteworthy. The publication of TRUST-I data in the Journal of Clinical Oncology and presentation at ASCO lend credibility to the drug's potential. The upcoming presentations at ESMO and WCLC will be important in supporting the planned NDA filing.
The Orphan Drug Designation for taletrectinib in ROS1-positive NSCLC is significant, potentially offering market exclusivity and development incentives. This, combined with the planned 2025 commercialization, positions taletrectinib as a near-term value driver.
The decision to reevaluate NUV-868's development path shows adaptability but also highlights the risks inherent in oncology drug development. Investors should closely monitor the progress of safusidenib and NUV-1511 as potential future value catalysts.
Nuvation Bio's focus on ROS1-positive NSCLC with taletrectinib targets a niche but growing market. The global NSCLC market is projected to reach
The company's strategic pivot away from certain NUV-868 indications demonstrates market responsiveness. However, this also underscores the importance of diversifying the pipeline to mitigate risks. The continued development of safusidenib and NUV-1511 provides some portfolio balance.
Investors should weigh the potential market opportunity against the increased expenses and net loss, considering the long-term value proposition of Nuvation Bio's oncology-focused pipeline.
Efficacy and safety data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s planned New Drug Application (NDA) in
Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung Cancer (WCLC)
Taletrectinib Granted Orphan Drug Designation by the
Strong balance sheet with cash, cash equivalents, and marketable securities of
“In the second quarter, we were pleased to share data at ASCO from TRUST-I, the pivotal study of taletrectinib in
Recent Pipeline Updates:
Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive NSCLC
-
Latest data from the Phase 2 TRUST-I clinical study evaluating taletrectinib in patients in
China with advanced ROS1-positive NSCLC was published in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting. -
Latest pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies to be presented at the ESMO Congress 2024 in September, which will support the Company’s planned NDA in the
U.S. - Latest data from the global, pivotal Phase 2 TRUST-II study to be presented at the WCLC in September.
-
Granted Orphan Drug Designation by the
U.S. FDA for the treatment of ROS1-positive NSCLC and other NSCLC indications.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma
- Global phase 2 study of safusidenib for treatment of patients with diffuse IDH1-mutant glioma remains ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors
- Phase 1/2 dose escalation study of NUV-1511 for the treatment of patients with various advanced solid tumors remains ongoing.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors
- Concluded the Phase 1b dose escalation study of NUV-868 in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC.
- Completed an internal analysis of efficacy and safety data collected from the Phase 1 monotherapy and Phase 1b combination studies of NUV-868. Following this analysis, Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs. 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.
Second Quarter 2024 Financial Results
As of June 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of
For the three months ended June 30, 2024, research and development expenses were
On April 9, 2024, as a result of the acquisition of AnHeart, Nuvation Bio recorded a
For the three months ended June 30, 2024, general and administrative expenses were
For the three months ended June 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 ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in
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 a
NUVATION BIO INC. and Subsidiaries | |||||||
Consolidated Balance Sheets | |||||||
Unaudited | |||||||
(In thousands, except share and per share data) | June 30, | December 31, | |||||
2024 |
2023 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ |
34,285 |
|
$ |
42,649 |
|
|
Accounts receivable, net of allowance for credit loss of $nil |
|
117 |
|
|
- |
|
|
Prepaid expenses and other current assets |
|
5,991 |
|
|
1,519 |
|
|
Marketable securities |
|
542,884 |
|
|
568,564 |
|
|
Interest receivable on marketable securities |
|
3,895 |
|
|
3,702 |
|
|
Total current assets |
|
587,172 |
|
|
616,434 |
|
|
Property and equipment, net of accumulated depreciation of |
|
751 |
|
|
717 |
|
|
Intangible assets, net of amortization of |
|
2,932 |
|
|
- |
|
|
Operating lease right-of-use assets |
|
2,723 |
|
|
3,605 |
|
|
Lease security deposit |
|
143 |
|
|
141 |
|
|
Other non-current assets |
|
1,075 |
|
|
587 |
|
|
Total assets | $ |
594,796 |
|
$ |
621,484 |
|
|
Liabilities, mezzanine equity and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ |
5,211 |
|
$ |
2,209 |
|
|
Current operating lease liabilities |
|
2,076 |
|
|
1,972 |
|
|
Contract liabilities, current portion |
|
12,200 |
|
|
- |
|
|
Short-term borrowings |
|
11,634 |
|
|
- |
|
|
Accrued expenses |
|
19,974 |
|
|
9,793 |
|
|
Total current liabilities |
|
51,095 |
|
|
13,974 |
|
|
Warrant liability |
|
1,441 |
|
|
353 |
|
|
Contract liabilities, net of current portion |
|
9,157 |
|
|
- |
|
|
Non-current operating lease liabilities |
|
972 |
|
|
2,035 |
|
|
Total liabilities |
|
62,665 |
|
|
16,362 |
|
|
Mezzanine equity; | |||||||
Class A convertible preferred stock, |
|
274,938 |
|
|
- |
|
|
Total mezzanine equity |
|
274,938 |
|
|
- |
|
|
Stockholders' equity | |||||||
Class A and Class B common stock and additional paid in capital, |
|
1,078,547 |
|
|
947,745 |
|
|
Accumulated deficit |
|
(820,088 |
) |
|
(342,804 |
) |
|
Accumulated other comprehensive income |
|
(1,266 |
) |
|
181 |
|
|
Total stockholders' equity |
|
257,193 |
|
|
605,122 |
|
|
Total liabilities, mezzanine equity and stockholders' equity | $ |
594,796 |
|
$ |
621,484 |
|
|
NUVATION BIO INC. and Subsidiaries | |||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(In thousands, except per share data) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||||||
Revenue | $ |
1,435 |
|
$ |
- |
|
$ |
1,435 |
|
$ |
- |
|
|||
Cost of revenue |
|
1,347 |
|
|
- |
|
|
1,347 |
|
|
- |
|
|||
Gross profit |
|
88 |
|
|
- |
|
|
88 |
|
|
- |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
29,247 |
|
|
18,590 |
|
|
42,089 |
|
|
37,377 |
|
|||
Acquired in-process research and development |
|
425,070 |
|
|
- |
|
|
425,070 |
|
|
- |
|
|||
General and administrative |
|
16,156 |
|
|
7,541 |
|
|
23,513 |
|
|
15,275 |
|
|||
Total operating expenses |
|
470,473 |
|
|
26,131 |
|
|
490,672 |
|
|
52,652 |
|
|||
Loss from operations |
|
(470,385 |
) |
|
(26,131 |
) |
|
(490,584 |
) |
|
(52,652 |
) |
|||
Other income (expense): | |||||||||||||||
Interest income |
|
7,144 |
|
|
6,086 |
|
|
14,274 |
|
|
11,065 |
|
|||
Interest expense |
|
(132 |
) |
|
- |
|
|
(132 |
) |
|
- |
|
|||
Investment advisory fees |
|
(247 |
) |
|
(231 |
) |
|
(512 |
) |
|
(461 |
) |
|||
Change in fair value of warrant liability |
|
1,135 |
|
|
(265 |
) |
|
(324 |
) |
|
(123 |
) |
|||
Realized loss on marketable securities |
|
(7 |
) |
|
(99 |
) |
|
(6 |
) |
|
(195 |
) |
|||
Total other income (expense), net |
|
7,893 |
|
|
5,491 |
|
|
13,300 |
|
|
10,286 |
|
|||
Loss before income taxes |
|
(462,492 |
) |
|
(20,640 |
) |
|
(477,284 |
) |
|
(42,366 |
) |
|||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Net loss | $ |
(462,492 |
) |
$ |
(20,640 |
) |
$ |
(477,284 |
) |
$ |
(42,366 |
) |
|||
Net loss attributable to common stockholders | |||||||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ |
(1.89 |
) |
$ |
(0.09 |
) |
$ |
(2.06 |
) |
$ |
(0.19 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
244,738 |
|
|
218,848 |
|
|
231,893 |
|
|
218,795 |
|
|||
Comprehensive loss: | |||||||||||||||
Net loss | $ |
(462,492 |
) |
$ |
(20,640 |
) |
$ |
(477,284 |
) |
$ |
(42,366 |
) |
|||
Other comprehensive loss, net of taxes: | |||||||||||||||
Currency translation adjustment |
|
148 |
|
|
- |
|
|
148 |
|
|
- |
|
|||
Unrealized (loss) gain on available-for-sale securities |
|
(245 |
) |
|
(1,457 |
) |
|
(1,595 |
) |
|
1,131 |
|
|||
Comprehensive loss | $ |
(462,589 |
) |
$ |
(22,097 |
) |
$ |
(478,731 |
) |
$ |
(41,235 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240805155584/en/
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
nuvation@argotpartners.com
Source: Nuvation Bio Inc.
FAQ
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