Nuvation Bio Inc

Previous wording

As a result of our April 2024 Acquisition of AnHeart Therapeutics Ltd. ("AnHeart"), our most advanced clinical-stage product candidate, 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 in China, and TRUST-II, a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration ("NMPA") for the treatment of patients with advanced or metastatic ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 tyrosine kinase inhibitors ("TKIs"). Worldwide development and commercial rights to taletrectinib have been in-licensed from Daiichi Sankyo. Commercial rights to taletrectinib have been out-licensed in China and Japan.

Current wording

As a result of our April 2024 acquisition of AnHeart Therapeutics Ltd. ("AnHeart"), our most advanced clinical-stage product candidate, 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 in patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study. Taletrectinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration ("NMPA") for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results of the TRUST-I and TRUST-II clinical studies, the Company submitted a New Drug Application (“NDA”) for taletrectinib to the U.S. FDA in October 2024 for the treatment of patients with advanced ROS1-positive NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 TKIs. Worldwide development and commercial rights to taletrectinib have been in-licensed from Daiichi Sankyo. Commercial rights to taletrectinib have been out-licensed in China and Japan.

Previous wording

Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with diffuse IDH1-mutant glioma.

Current wording

Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). Safusidenib is being evaluated in a Phase 2 study in patients with diffuse IDH1-mutant glioma.

Previous wording

NUV-1511 is our first clinical-stage drug-drug conjugate ("DDC"), which fuses a targeting agent to a widely used chemotherapy agent. NUV-1511 is being evaluated in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. FDA labeling, human epidermal growth factor receptor 2-negative ("HER2-") metastatic breast cancer, metastatic castration-resistant prostate cancer (“mCRPC”), advanced pancreatic cancer, and platinum-resistant ovarian cancer ("PROC").

Current wording

NUV-1511 is our first clinical-stage drug-drug conjugate ("DDC"), which fuses a targeting agent to a widely used chemotherapy agent. NUV-1511 is being evaluated in a Phase 1/2 study in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. FDA labeling, human epidermal growth factor receptor 2-negative ("HER2-") metastatic breast cancer, metastatic castration-resistant prostate cancer (“mCRPC”), advanced pancreatic cancer, and platinum-resistant ovarian cancer ("PROC").

Previous wording

NUV-868 is a BD2-selective, oral, small molecule bromodomain and extra-terminal ("BET") inhibitor that inhibits BRD4. NUV-868 has completed a Phase 1 monotherapy study for the treatment of patients with advanced solid tumors and a Phase 1b study in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, mCRPC, triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC. After an internal analysis of efficacy and safety data collected from these studies, we have 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. We are 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.

Current wording

NUV-868 is a BD2-selective, oral, small molecule bromodomain and extra-terminal ("BET") inhibitor that inhibits BRD4. As previously announced, we are 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.

Previous wording

In July 2024, we announced that we will present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC at the European Society of Medical Oncology Congress 2024, which will support our planned New Drug Application in the United States.

Current wording

In September 2024, we announced pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1-positive NSCLC, which was presented at the European Society of Medical Oncology Congress 2024.

Previous wording

We have incurred net losses in each year since inception. As of June 30, 2024, we had an accumulated deficit of $820.1 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

Current wording

We have incurred net losses in each year since inception. As of September 30, 2024, we had an accumulated deficit of $861.3 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

Previous wording

Results of Operations for The Three and Six Months Ended June 30, 2024 and 2023

Current wording

Results of Operations for The Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

The following table summarizes total revenue recognized for the three and six months ended June 30, 2024:

Current wording

The following table summarizes total revenue recognized for the three and nine months ended September 30, 2024:

Previous wording

Research and development expenses increased by $10.6 million for the three months ended June 30, 2024 compared to 2023. The increase was primarily due to a $5.9 million increase in personnel-related costs driven by the Acquisition of AnHeart, stock-based compensation and other benefits and a $4.7 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib.

Current wording

Research and development expenses increased by $9.2 million for the three months ended September 30, 2024 compared to 2023. The increase was primarily due to a $6.7 million increase in personnel-related costs driven by the acquisition of AnHeart, stock-based compensation and other benefits, $2.4 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib and $0.1 million increase in amortization of assembled workforce.

Previous wording

Research and development expenses increased by $4.7 million for the six months ended June 30, 2024 compared to 2023. The increase was primarily due to a $6.6 million increase in personnel-related costs driven by the Acquisition of AnHeart as well as stock-based compensation and other benefits offset by $1.9 million decrease in third-party costs related to research services and drug manufacturing as a result of completing the Phase 1 monotherapy study of NUV-868 .

Current wording

Research and development expenses increased by $13.9 million for the nine months ended September 30, 2024 compared to 2023. The increase was primarily due to a $13.5 million increase in personnel-related costs driven by the acquisition of AnHeart as well as stock-based compensation and other benefits and $0.2 million increase in amortization of assembled workforce and $0.2 million increase in third-party costs related to clinical trial expense for taletrectinib offset by decrease in research services and drug manufacturing as a result of completing the Phase 1 monotherapy study of NUV-868.

Previous wording

General and administrative expenses increased by $8.6 million for the three months ended June 30, 2024, compared to 2023. The increase was due to a $3.9 million increase in personnel-related costs as a result of the Acquisition of AnHeart, $1.1 million increase in professional fees, $1.2 million increase in marketing expense, $0.8 million increase in legal fees, $0.2 million increase in occupancy expense, $0.2 million increase in foreign currency impact and a $1.4 million increase in miscellaneous expense offset by a $0.2 million decrease in insurance expense.

Current wording

General and administrative expenses increased by $11.8 million for the three months ended September 30, 2024, compared to 2023. The increase was due to a $5.3 million increase in personnel-related costs as a result of the acquisition of AnHeart, $4.2 million increase in sales and marketing expense, $1.8 million increase in professional fees, $0.7 million increase in legal fees, $0.4 million increase in occupancy expense offset by $0.4 million increase in foreign currency impact and $0.2 million decrease in insurance expense.

Previous wording

General and administrative expenses increased by $8.2 million for the six months ended June 30, 2024, compared to 2023. The increase was due to a $3.8 million increase in personnel-related costs as a result of the Acquisition of AnHeart, $1.2 million increase in professional fees, $1.2 million increase in marketing expense, $0.6 million increase in legal fees, $0.3 million increase in occupancy expense, $0.2 million in foreign currency impact and a $1.5 million increase in miscellaneous expense offset by a $0.6 million decrease in insurance.

Current wording

General and administrative expenses increased by $20.0 million for the nine months ended September 30, 2024, compared to 2023. The increase was due to a $9.1 million increase in personnel-related costs as a result of the acquisition of AnHeart, $5.4 million increase in sales and marketing expense, $3.3 million increase in professional fees, $1.7 million increase in occupancy expense, $1.3 million increase in legal fees and $0.1 million increase in amortization of assembled workforce offset by $0.8 million decrease in insurance and $0.1 million in foreign currency impact.

Previous wording

Other income (expense), net increased by $2.4 million for the three months ended June 30, 2024 compared to 2023 primarily related to interest income from investments increase of $1.0 million in 2024 primarily because of higher treasury yield in 2024 compared to 2023, a $1.4 million increase in the change of fair value of warrant compared to prior year and a decrease of net loss of $0.1 million on marketable securities offset by a $0.1 million increase in interest expense.

Current wording

Other income (expense), net increased by $0.2 million for the three months ended September 30, 2024 compared to 2023 primarily related to interest income from investments increase of $0.2 million in 2024 primarily because of higher treasury yield in 2024 compared to 2023 and a $0.1 million increase in the change of fair value of warrant compared to prior year offset by $0.1 increase in interest expense.

Previous wording

Other income (expense), net increased by $3.0 million for the six months ended June 30, 2024 compared to 2023 primarily related to interest income from investments increase of $3.2 million in 2024 primarily because of higher treasury yield in 2024 compared to 2023 and a decrease of net loss of $0.2 million was primarily due to sale of U.S. Treasuries at losses in 2023 offset by a $0.2 million increase in the change of fair value of warrant compared to prior year, $0.1 million increase in interest expense and a $0.1 million increase in investment advisory fees.

Current wording

Other income (expense), net increased by $3.2 million for the nine months ended September 30, 2024 compared to 2023 primarily related to interest income from investments increase of $3.4 million in 2024 primarily because of higher treasury yield in 2024 compared to 2023 and a decrease of net loss of $0.2 million was primarily due to sale of U.S. Treasuries at losses in 2023 offset by a $0.1 million increase in the change of fair value of warrant compared to prior year, $0.2 million increase in interest expense and a $0.1 million increase in investment advisory fees.

Previous wording

From inception through June 30, 2024, our operations have been financed primarily by the sale and issuance of Series A preferred stock and Common Stock. As of June 30, 2024, we had $577.2 million in cash, cash equivalents and marketable securities and an accumulated deficit of $820.1 million.

Current wording

From inception through September 30, 2024, our operations have been financed primarily by the sale and issuance of Series A preferred stock and Common Stock. As of September 30, 2024, we had $549.1 million in cash, cash equivalents and marketable securities and an accumulated deficit of $861.3 million.

Previous wording

In 2024, cash used in operating activities of $53.0 million was attributable to a net loss of $477.3 million, a net change of $10.7 million in our net operating assets and liabilities offset by non-cash charges of $435.0 million. The change in operating assets and liabilities was primarily due to a $4.0 decrease in accrued expenses, $2.8 million decrease in accounts payable, $1.7 million increase in prepaid expenses and other current assets, $1.4 million decrease in contract liabilities, $0.2 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets and $0.1 million increase in accounts receivable. The non-cash charges consisted primarily of $425.1 million of acquired in-process research and development, stock-based compensation of $14.6 million and changes in fair value of warrant liability of $0.3 million, $0.3 million of depreciation and amortization offset by amortization of premium on marketable securities of $5.2 million and $0.1 million of non cash lease expense.

Current wording

In 2024, cash used in operating activities of $84.1 million was attributable to a net loss of $518.5 million, a net change of $5.7 million in our net operating assets and liabilities offset by non-cash charges of $440.1 million. The change in operating assets and liabilities was primarily due to a $1.9 million decrease in contract liabilities, $7.3 million increase in prepaid expenses and other current assets, $0.5 million decrease in accrued expenses, $0.4 million increase in interest receivable on marketable securities and $0.1 million increase in accounts receivable offset by $4.4 million increase in accounts payable and $0.1 million decrease in other non-current assets. The non-cash charges consisted primarily of $425.1 million of acquired in-process research and development, stock-based compensation of $22.1 million, $0.4 million of depreciation and amortization and $0.2 million of net loss on disposal of property and equipment offset by amortization of premium on marketable securities of $7.4 million, changes in fair value of warrant liability of $0.2 million and $0.1 million of non cash lease expense.

Previous wording

In 2023, cash used in operating activities of $36.8 million was attributable to a net loss of $42.4 million offset by a net change of $0.2 million in our net operating assets and liabilities and non-cash charges of $5.4 million. The change in operating assets and liabilities was primarily due to a $0.5 million increase in accounts payable, $0.3 million decrease in prepaid expenses offset by $0.3 million increase in interest receivable on marketable securities and $0.3 million decrease in accrued expenses. The non-cash charges consisted primarily of stock-based compensation of $10.4 million, realized loss on marketable securities of $0.2 million, depreciation and amortization of $0.1 million and changes in fair value of warrant liability of $0.1 million offset by amortization of premium on marketable securities of $5.4 million.

Current wording

In 2023, cash used in operating activities of $53.0 million was attributable to a net loss of $62.0 million offset by a net change of $2.0 million in our net operating assets and liabilities and non-cash charges of $7.0 million. The change in operating assets and liabilities was primarily due to a $2.0 million increase in accrued expenses, $0.9 million decrease in prepaid expenses and $0.2 million increase in accounts payable, offset by $0.5 million increase in interest receivable on marketable securities and $0.6 million increase in other non-current assets. The non-cash charges consisted primarily of stock-based compensation of $15.8 million, realized loss on marketable securities of $0.2 million, and depreciation and amortization of $0.1 million offset by changes in fair value of warrant liability of $0.3 million and amortization of premium on marketable securities of $8.8 million.

Previous wording

In 2024, cash provided by investing activities of $41.8 million was related to the $251.3 million of proceeds from the sale of marketable securities, $19.8 cash acquired from the Acquisition of AnHeart, offset by purchase of marketable securities of $221.9 million and $7.4 million of transaction costs related to the Acquisition of AnHeart.

Current wording

In 2024, cash provided by investing activities of $70.9 million was related to the $366.2 million of proceeds from the sale of marketable securities, $19.9 cash acquired from the acquisition of AnHeart, offset by purchase of marketable securities of $307.6 million, $7.4 million of transaction costs related to the acquisition of AnHeart and purchase of property and equipment of $0.2 million.

Previous wording

In 2023, cash used for investing activities of $14.6 million was related to the purchase of marketable securities of $443.8 million offset by $429.2 million of proceeds from the sale of marketable securities.

Current wording

In 2023, cash used for investing activities of $24.2 million was related to the purchase of marketable securities of $554.6 million offset by $530.4 million of proceeds from the sale of marketable securities.

Previous wording

In 2024, cash provided by financing activities of $2.8 million was related to the $2.0 million proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan, $7.0 million of proceeds from borrowings offset by $6.3 million of debt repayments.

Current wording

In 2024, cash provided by financing activities of $1.2 million was related to the $3.6 million proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan and $7.0 million of proceeds from borrowings offset by $9.5 million of debt repayments.

Previous wording

In 2023, cash provided by financing activities of $0.4 million was related to the $0.3 million of proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan.

Current wording

In 2023, cash provided by financing activities of $0.5 million was related to the $0.4 million of proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan.