Nuvation Bio Inc
For the period ended Jun 30, 2024. Filed Aug 5, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 5, 2024
NUVB$4.16-0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0000950170-24-059622
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-05.
0000950170-24-090347
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 76 previous paragraphs and 108 current paragraphs.
50 unchanged; 23 reworded; 34 added; 2 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 2 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (34)
Current report
In June 2024, we announced data from our pivotal Phase 2 TRUST-I study evaluating taletrectinib in patients in China, which was published in the Journal of Clinical Oncology (Zhou et al., 2024) and presented at the American Society of Clinical Oncology Annual Meeting (Li et al., 2024).
Current report
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 report
In July 2024, we announced that taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of ROS1-positive NSCLC and other NSCLC indications.
Current report
In July 2024, we terminated our exclusive license agreement with NewG Lab Co., Ltd. (“NewG Lab”). AnHeart previously entered into an agreement with NewG Lab to develop and commercialize taletrectinib in Korea.
Current report
We have 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, 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 report
Revenues
Current report
The Company enters into collaborative arrangements for the research and development, and commercialization of drug products and drug candidates. To date, these collaborative arrangements have included out-licenses of and options to out-license in-licensed compound to other parties and in-licenses of compound from other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments.
Current report
The Company receives payments from its customers based on billing terms established in the contract. Up-front payments and fees are recorded as contract liabilities (e.g., deferred revenue) upon receipt or when due until the Company performs its obligations under the arrangement. In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled.
Current report
Revenues
Current report
The Company's revenue related to its out-licensing collaborative agreements consist of upfront license fees and research and development services revenue from its collaboration agreements.
Current report
The following table summarizes total revenue recognized for the three and six months ended June 30, 2024:
Current report
There was no revenue in 2023 since the Acquisition of AnHeart completed in the second quarter of 2024.
Current report
The following table presents a breakdown of our operating expenses by functional category:
Current report
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 report
Acquired In-process Research and Development Expenses
Current report
On April 9, 2024, as a result of the Acquisition of AnHeart, we recorded a $425.1 million charge representing an acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.
Current report
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 report
The following table presents a breakdown of our other income (expense):
Current report
Revenue Recognition
Current report
The Company applies ASC Topic 606, "Revenue from Contracts with Customers" ("ASC 606") to account for its revenue transactions. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the five-step model. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which of these performance obligations are distinct. The Company recognizes as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. Accounts receivable represent amounts invoiced and revenues recognized prior to invoicing when the Company has satisfied its performance obligation and has the unconditional right to payment.
Current report
Collaborative Arrangement
Current report
In November 2018, the FASB issued Topic 808, "Collaborative Arrangements" ("ASC 808"): Clarifying the Interaction between ASC 808 and ASC 606. This update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer and precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue from contracts with customers if the counterparty is not a customer for that transaction. The Company adopted this standard for all periods presented. The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products and drug candidates. The Company assessed and determined that none of the collaboration agreements entered into during the periods presented were within the scope of ASC 808, as all of the agreements did not involve active participation by both parties in a joint research activity, and therefore did not qualify as collaborative arrangements under ASC 808. The Company has determined that all the elements of the above collaborations are reflective of a vendor-customer relationship and therefore within the scope of ASC 606. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step model under ASC 606 noted above. The Company recognizes revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to receive in exchange for those goods or services. The Company's collaborative arrangements may contain more than one unit of account, or performance obligation, including grants of licenses to intellectual property rights, agreements to provide research and development services and other deliverables. The collaborative arrangements do not include a right of return for any deliverable. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. In developing the stand-alone selling price for a performance obligation, the Company considers competitor pricing for a similar or identical product, market awareness of and perception of the product, expected product life and current market trends. In general, the consideration allocated to each performance obligation is recognized when the respective obligation is satisfied either by delivering a good or providing a service, limited to the consideration that is not constrained. Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded as contract liabilities.
Current report
Licenses of intellectual property
Current report
If a license to the Company's intellectual property is determined to be distinct from the other promises or performance obligations identified in the contract, the Company recognizes revenue from the portion of the transaction price allocated to the license at a point in time, when the license is transferred to the customer and the customer is able to benefit from the license.
Current report
Research and development services
Current report
The portion of a transaction price allocated to research and development services performance obligations is deferred and recognized as revenue over time as delivery or performance of such services occurs based on the use of an input method.
Current report
Customer options
Current report
A customer's right to choose, at its discretion, to make a payment for additional goods or services is generally considered an option. If the Company is not presently obligated to provide and does not have a right to consideration for delivering additional goods or services, the item is considered an option. The Company evaluates the customer options for material rights, such as the ability to acquire additional goods or services for free or a discount. Optional future services that reflect their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. The optional future services do not include a material right to be accounted for as performance obligations.
Current report
Milestones payments
Current report
The Company's collaboration agreements include development and regulatory milestones. The Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company's control or the licensee's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.
Current report
Royalties
Current report
For sales-based royalties, including milestone payments based on the level of sales, the Company determines whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, the Company recognizes revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any sales-based royalty revenue resulting from the Company's collaboration agreements.
Current report
The Company receives payments from its customers based on billing terms established in the contract. Up-front payments and fees are recorded as contract liabilities (e.g., deferred revenue) upon receipt or when due until the Company performs its obligations under the arrangement.
Current report
In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. For a complete discussion of accounting for revenue, see the section titled "Collaboration and License Agreements" in Note 5 to our consolidated financial statements for the three months ended June 30, 2024 appearing elsewhere in this report.
Removed paragraphs (2)
Previous report
In January 2024, we announced that the FDA cleared an Investigational New Drug (“IND”) application for NUV-1511, the first clinical candidate from our DDC platform.
Previous report
Results of Operations
Reworded paragraphs (23)
Previous wording
We are a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. We were founded in 2018 by our chief executive officer, David Hung, M.D., who founded Medivation, Inc. and led its successful development of oncology drugs Xtandi® and talazoparib (now marketed as Talzenna®), leading to its $14.3 billion sale to Pfizer Inc. (“Pfizer”) in 2016. We leverage our team’s extensive expertise in medicinal chemistry, preclinical development, drug development, and business development to pursue oncology targets validated by strong clinical or preclinical data and develop novel small molecules that improve the activity and overcome the liabilities of currently marketed drugs.
Current wording
We are a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. We were founded in 2018 by our chief executive officer, David Hung, M.D., who founded Medivation, Inc. and led its successful development of oncology drugs Xtandi® and talazoparib (now marketed as Talzenna®), leading to its $14.3 billion sale to Pfizer Inc. (“Pfizer”) in 2016. We leverage our team’s extensive expertise in medicinal chemistry, preclinical development, drug development, business development, manufacturing, and commercialization to pursue oncology targets validated by strong clinical or preclinical data and develop novel small molecules that improve the activity and overcome the liabilities of currently marketed drugs.
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 advanced 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 Breakthrough Therapy Designations by both the U.S. Food and Drug Administration ("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, Japan, and Korea.
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 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.
Previous wording
In addition to taletrectinib, our pipeline includes differentiated, novel oncology therapeutic candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:
Current wording
In addition to taletrectinib, our clinical-stage pipeline includes differentiated, novel oncology product candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:
Previous wording
Safusidenib, a novel, oral, potent, targeted inhibitor of mutant IDH1, ("mIDH1"), which is being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 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 global Phase 2 study for the treatment of patients with diffuse IDH1-mutant glioma.
Previous wording
NUV-1511, our first clinical-stage drug-drug conjugate ("DDC"), which 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, 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 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").
Previous wording
NUV-868, a BD2-selective, oral, small molecule bromodomain and extra-terminal ("BET") inhibitor that inhibits BRD4, which is being evaluated in a Phase 1b dose escalation study 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
Current 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.
Previous wording
Since our inception in 2018, we have focused substantially all of our resources on conducting research and development activities, including drug discovery, preclinical studies, clinical trials, establishing and maintaining our intellectual property portfolio, developing our manufacturing network and managing the manufacture of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. We have not recorded revenue from product sales or collaboration activities, or any other source. We have funded our operations to date primarily from the issuance and sale of our common and preferred stock, including through the Merger and a Private Investment in Public Equity ("PIPE") financing in connection with the Merger.
Current wording
Since our inception in 2018, we have focused substantially all of our resources on conducting research and development activities, including drug discovery, preclinical studies, clinical trials, establishing and maintaining our intellectual property portfolio, developing our manufacturing network and managing the manufacture of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. The Company's revenue related to its out-licensing collaborative agreements consist of upfront license fees and research and development services revenue from its collaboration agreements. We have funded our operations to date primarily from the issuance and sale of our common and preferred stock, including through the Merger and a Private Investment in Public Equity ("PIPE") financing in connection with the Merger.
Previous wording
We have incurred net losses in each year since inception. As of March 31, 2024, we had an accumulated deficit of $361.2 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 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:
Previous wording
Three Months Ended March 31, 2024 and 2023
Current wording
Results of Operations for The Three and Six Months Ended June 30, 2024 and 2023
Previous wording
Research and development expenses decreased by $6.0 million for the three months ended March 31, 2024 compared to 2023. The decrease was primarily due to a $6.7 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 offset by $0.7 increase in personnel-related costs driven by stock-based compensation and other benefits.
Current 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 .
Previous wording
General and administrative expenses decreased by $0.4 million for the three months ended March 31, 2024, compared to 2023. The decrease was due to a $0.5 million decrease in professional fees, $0.4 million decrease in insurance and a $0.2 million decrease in personnel-related costs offset by a $0.4 million increase in legal fees, $0.2 million increase in occupancy expense and a $0.1 million increase in miscellaneous expense.
Current 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.
Previous wording
Other income (expense), net increased by $0.6 million for the three months ended March 31, 2024 compared to 2023 primarily related to interest income from investments increase of $2.1 million in 2024 primarily because of higher treasury yield in 2024 compared to 2023 and a decrease of net loss of $0.1 million was primarily due to sale of U.S. Treasuries at losses in 2023 offset by a $1.6 million increase in the change of fair value of warrant compared to prior year.
Current 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.
Previous wording
From inception through March 31, 2024, our operations have been financed primarily by the sale and issuance of Series A preferred stock and common stock. As of March 31, 2024, we had $597.0 million in cash, cash equivalents and marketable securities and an accumulated deficit of $357.6 million.
Current 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.
Previous wording
Our primary use of cash is to fund operating expenses, which consist of research and development expenses related to our clinical stage product candidates, NUV-868 and NUV-1511, and preclinical programs, and to a lesser extent, general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Current wording
Our primary use of cash is to fund operating expenses, which consist of research and development expenses related to our clinical-stage product candidates and preclinical programs, and to a lesser extent, general and administrative expenses. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
Previous wording
We expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our product candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing or aggregate amount of costs for our development, potential commercialization, and internal research and development programs. However, in order to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our product candidates, as well as to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we may require substantial additional funding in the future.
Current wording
We expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our product candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing or aggregate amount of costs for our development, potential commercialization, and internal research and development programs. However, in order to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our product candidates, as well as to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding in the future.
Previous wording
In 2024, cash used in operating activities of $15.7 million was attributable to a net loss of $14.8 million, a net change of $4.6 million in our net operating assets and liabilities offset by non-cash charges of $3.7 million. The change in operating assets and liabilities was primarily due to a $5.3 million increase in prepaid expenses and other current assets, $0.6 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets offset by $1.5 increase in accrued expenses and $0.3 million increase in accounts payable. The non-cash charges consisted primarily of stock-based compensation of $5.0 million and changes in fair value of warrant liability of $1.5 million offset by amortization of premium on marketable securities of $2.8 million.
Current 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.
Previous wording
In 2023, cash used in operating activities of $19.3 million was attributable to a net loss of $21.7 million, a net change of $0.3 million in our net operating assets and liabilities offset by non-cash charges of $2.7 million. The change in operating assets and liabilities was primarily due to a $1.4 million decrease in accrued expenses offset by $0.8 million increase in accounts payable, $0.2 million decrease in interest receivable on marketable securities and $0.1 million decrease in prepaid expenses. The non-cash charges consisted primarily of stock-based compensation of $4.8 million and loss on marketable securities of $0.1 million offset by amortization of premium on marketable securities of $2.1 million and changes in fair value of warrant liability of $0.1 million.
Current 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.
Previous wording
In 2024, cash provided by investing activities of $7.5 million was related to the purchase of marketable securities of $128.5 million offset by $136.0 million of proceeds from the sale of marketable securities.
Current 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.
Previous wording
In 2023, cash used in for investing activities of $52.0 million was related to the purchase of marketable securities of $237.0 million offset by $185.0 million of proceeds from the sale of marketable securities.
Current 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.
Previous wording
In 2024, cash provided by financing activities of $21 thousand was related to the proceeds from exercise of options.
Current 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.
Previous wording
In 2023, cash provided by financing activities of $0.3 million was related to the proceeds from exercise of options.
Current 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.
Previous wording
Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.
Current wording
Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions. While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.
Previous wording
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of Public and Forward Purchase Warrants was determined using the closing price of the warrants on the NYSE market. The fair value of the Private Warrants was estimated using the Black-Scholes option pricing formula (see Note 3).
Current wording
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of Consideration, Public, and Forward Purchase Warrants was determined using the closing price of the publicly traded warrants on the NYSE market. The fair value of the Private Warrants was estimated using the Black-Scholes option pricing formula. See the section titled "Fair Value Measurements and Marketable Securities Available-for-Sale" in Note 4 to our consolidated financial statements for the three months ended June 30, 2024 appearing elsewhere in this report.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
While our significant accounting policies are described in the notes to our consolidated financial statements, we believe that the following critical accounting policies are most important to understanding and evaluating our reported financial results.