PUMA BIOTECHNOLOGY, INC.

Previous wording

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approximately 38 sales specialists. Our sales specialists are supported by an experienced sales leadership team consisting of several regional business leaders and a VP of sales as well as experienced professionals in marketing, managed markets, access and reimbursement, market research, and sales planning and operations. Outside the United States, we seek to enter into exclusive sub-license agreements with third parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved. As of September 30, 2024, NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 40 countries outside the United States. We are currently party to several sub-licenses in various regions outside the United States, including Europe (excluding Russia and Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, and various countries and territories in Central America, South America, Africa and the Middle East.

Current wording

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approxima tely 40 sales specialists. Our sales specialists are supported by an experienced sales leadership team consisting of several regional business leaders and a Vice President of sales, as well as experienced professionals in marketing, managed markets, access and reimbursement, research, and sales planning and operations. Outside the United States, we seek to enter into exclusive sub-license agreements with third parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved. As of March 31 2025, NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in over 50 countries outside the United States. We are currently party to several sub-licenses in various regions outside the United States, including Europe (excluding Russia and Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, and various countries and territories in Central America, South America, Africa and the Middle East.

Previous wording

In September 2022, we entered into an exclusive license agreement with Takeda to license the worldwide research and development and commercial rights to alisertib. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for aurora kinase A. Inhibition of aurora kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. In clinical trials to date, alisertibhas shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. We initiated the ALISertib in CAncer (ALISCA™ -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we plan to commence the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in the fourth quarter of 2024.

Current wording

In September 2022, we entered into an exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for Aurora Kinase A. Inhibition of Aurora Kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. In clinical trials to date, alisertib has shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. We initiated the ALISertib in CAncer (ALISCA™ -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we commenced the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in November of 2024.

Previous wording

Under the terms of the exclusive license agreement, we assumed sole responsibility for the global development and commercialization of alisertib. We paid Takeda an upfront license fee of $7.0 million in October 2022, and it is eligible to receive potential future milestone payments of up to $287.3 million upon our achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib. We recorded in-process research and development expense of $7.0 million during the year ended December 31, 2022 in connection with the up-front payment related to the asset acquisition. As of September 30, 2024, no milestones had been accrued as the underlying contingencies were not probable or estimable.

Current wording

Under the terms of the exclusive license agreement, we assumed sole responsibility for the global development and commercialization of alisertib. We paid Takeda an upfront license fee of $7.0 million in October 2022, and it is eligible to receive potential future milestone payments of up to $287.3 million upon our achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib. We recorded in-process research and development expense of $7.0 million during the year ended December 31, 2022, in connection with the upfront payment related to the asset acquisition. As of March 31, 2025, no milestones had been accrued as the underlying contingencies were not probable or estimable.

Previous wording

Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials and the build out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX. Accordingly, our success depends not only on the safety and efficacy of our drug candidates, but also on our ability to finance product development. To date, our major sources of working capital have been proceeds from product and license revenue, public offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements. We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of September 30, 2024, and proceeds that will become available to us through product sales, royalties and sub-license milestone payments. However, this intention is based on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including changes in and progress of our development activities, the impact of commercialization efforts, acquisitions of additional drug candidates and changes in regulation. Some of these developments have had and may continue to have an adverse effect on our revenue and thus could have an adverse effect on our ability to satisfy the minimum revenue and cash balance covenants contained in the Athyrium Notes.

Current wording

Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials, building out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX. Going forward, we anticipate significant expenses as we continue to develop alisertib in 2025. Accordingly, our success depends not only on the safety and efficacy of our drug candidates, but also on our ability to finance product development. To date, our major sources of working capital have been proceeds from product and license revenue, public offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements. We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of March 31, 2025, and proceeds that will become available to us through product sales, royalties and sub-license milestone payments. However, this intention is based on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including changes in and progress of our development activities, the impact of commercialization efforts, acquisition of additional drug candidates and changes in regulation. Some of these developments have had and may continue to have an adverse effect on our revenue and thus could have an adverse effect on our ability to satisfy the minimum revenue and cash balance covenants contained in the Athyrium Notes.

Previous wording

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2024 from our accounting policies at December 31, 2023, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Current wording

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2025 from our accounting policies at December 31, 2024, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Previous wording

Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials. During the three and nine months ended September 30, 2024 and 2023, our R&D expenses consisted primarily of clinical research organization (“CRO fees”); fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

Current wording

Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials. During the three months ended March 31, 2025 and 2024, our R&D expenses consisted primarily of clinical research organization (“CRO fees”); fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

Previous wording

Total revenue for the nine months ended September 30, 2024 was approximately $171.4 million, compared to $163.5 million for the nine months ended September 30, 2023. This increase in total revenue was primarily due to an increase of $17.1 million in royalty revenue offset by a decrease of $9.1 million in product revenue, net.

Current wording

Total revenue for the three months ended March 31, 2025 was approximately $46.0 million, compared to $43.8 million for the three months ended March 31, 2024. This increase in total revenue was primarily due to an increase in product revenue, net of approximately $2.8 million, partially offset by a decrease in royalty revenue of $0.6 million.

Previous wording

Product revenue, net was approximately $56.1 million for the three months ended September 30, 2024, compared to $51.6 million for the three months ended September 30, 2023. This increase in product revenue, net was primarily attributable to an increase in product sales to our China sub-licensee, and an increase in net selling price compared to the three months ended September 30, 2023, partially offset by a decrease of approximately 5.2% in bottles of NERLYNX sold in the U.S. market, and an increase of approximately 2.5% in related deductions to gross revenue for variable consideration compared to the three months ended September 30, 2023.

Current wording

Product revenue, net was approximately $43.1 million for the three months ended March 31, 2025, compared to $40.3 million for the three months ended March 31, 2024. This increase in product revenue, net, compared to the three months ended March 31, 2024, was primarily attributable to an increase in net selling price, partially offset by a decrease of approximately 3.0%in bottles of NERLYNX sold in the U.S. market, and a decrease of approximately 2.6% in related deductions to gross revenue for variable consideration.

Previous wording

SG&A expenses were approximately $16.8 million for the three months ended September 30, 2024, compared to approximately $22.8 million for the three months ended September 30, 2023. SG&A expenses for the three months ended September 30, 2024 and 2023 were as follows:

Current wording

SG&A expenses were approximately $17.6 million for the three months ended March 31, 2025, compared to approximately $21.8 million for the three months ended March 31, 2024. SG&A expenses for the three months ended March 31, 2025 and 2024 were as follows:

Previous wording

SG&A expenses decreased by approximately$6.0 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current wording

SG&A expenses decreased by approximately$4.2 million for the three months ended March 31, 2025, compared to the same period in 2024, primarily attributable to the following:

Previous wording

R&D expenses were approxi mately$12.6 million for thethree months ended September 30, 2024, compared to approximately $11.5 million for the three months ended September 30, 2023. R&D expenses for the three months ended September 30, 2024 and 2023, were as follows:

Current wording

R&D expenses were approxi mately$13.9 million for thethree months ended March 31, 2025, compared to approximately $13.6 million for the three months ended March 31, 2024. R&D expenses for the three months ended March 31, 2025 and 2024, were as follows:

Previous wording

R&D expenses increased by approxim ately$1.1 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately$0.3 million for the three months ended March 31, 2025, compared to the same period in 2024, primarily attributable to the following:

Previous wording

For the three months ended September 30, 2024, we recognized approximately $1.3 million in interest income, compared to approximately $0.7 million of interest income for the three months ended September 30, 2023. The increase in interest income was primarily the result of increased balances in cash equivalents and marketable securities.

Current wording

For the three months ended March 31, 2025, we recognized approximately $1.1 million in interest income, compared to approximately $1.0 million of interest income for the three months ended March 31, 2024. The increase in interest income was primarilythe result of improved investment management.

Previous wording

For the three months ended September 30, 2024, we recognized approximately $3.1 million in interest expense, compared to approximately $3.3 million of interest expense for the three months ended September 30, 2023. The decrease in interest expense related to a lower debt balance as we began paying down our debt principal during the three months ended September 30, 2024.

Current wording

For the three months ended March 31, 2025, we recognized approximately $2.2 million in interest expense, compared to approximately $3.4 million of interest expense for the three months ended March 31, 2024. The decrease in interest expense was primarily related to a lower debt balance as we began paying down our debt principal during the three months ended June 30, 2024.

Previous wording

For the three months ended September 30, 2024, we recognized approximately $0.3 million in other income, compared to approximately $0.1 million of other income for the three months ended September 30, 2023. The increase inother income was primarily due to increased sublease income, in addition to favorable exchange rates in Euro-denominated transactions.

Current wording

For the three months ended March 31, 2025, we recognized approximately $0.4 million in other income, compared to approximately $0.1 million of other income for the three months ended March 31, 2024. The increase inother income was primarily dueto favorable exchange rates in Euro-denominated transactions.

Previous wording

The following table, which summarizes our liquidity and capital resources as of September 30, 2024 and December 31, 2023 and for the nine months ended September 30, 2024 and 2023, is intended to supplement the more detailed discussion that follows:

Current wording

The following table, which summarizes our liquidity and capital resources as of March 31, 2025 and December 31, 2024 and for the three months ended March 31, 2025 and 2024, is intended to supplement the more detailed discussion that follows:

Previous wording

On October 26, 2023, we implemented a reduction in our workforce of approximately 5% across the Company. We incurred approximately $0.4 million in related costs, which include severance payments and insurance premiums. These costs were recorded in the fourth quarter of 2023. All payments related to this plan were paid as of March 31, 2024.

Current wording

On October 26, 2023, we implemented a reduction in our workforce of approximately 5% across the Company. We incurred approximately $0.4 million in related costs, which included severance payments and insurance premiums. These costs were recorded in the fourth quarter of 2023. All payments related to this plan were paid as of March 31, 2024.

Previous wording

Cash provided by operating activities for the nine months ended September 30, 2023 was $16.6 million and consisted of net income of approximately $9.3 million, offset by a decrease of approximately $17.6 million of non-cash items. These non-cash items included stock-based compensation, depreciation and amortization, provision for credit loss and loss on impairment of asset. In addition, there were decreases in cash flows from operations due to a decrease in accrued expenses and other of approximately $18.9 million, which included an $8.0 million payment related to the Eshelman litigation settlement, net, a decrease of $3.3 million in variable consideration and $2.5 million in the employee bonus accrual, and a net decrease of $4.0 million in our Pfizer royalty accrual. Additional decreases in cash flows were due to a decrease in our post-marketing commitment liability of approximately $0.7 million, a decrease of $1.4 million in accounts payable and an increase of $1.2 million in inventory. These decreases in cash flows were partially offset by increases in cash flows due to a decrease of $10.9 million in accounts receivable from collections and a decrease of $1.4 million in prepaid and other expenses. The decrease of $0.4 million in other current assets was due to receipt of CARES Act funds, partially offset by an increase of a $1.7 million receivable from a vendor related to damaged inventory.

Current wording

Cash provided by operating activities for thethree months ended March 31, 2025 was$3.6 million and consisted of net income of approximately$3.0 million, adjusted for non-cash items of approximately $5.0 million, which included stock-based compensation of $2.0 million, depreciation and amortization of $2.8 million and provision for credit loss of $0.2 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accrued expenses and other of approximately $9.9 million, a decrease in operating lease assets and liabilities, net, of $0.4 million and a decrease of post-marketing commitment liability of $0.4 million and an increase in prepaid and other expenses of $0.8 million, partially offset by a decrease in accounts receivable of approximately $6.6 million and an increase in accounts payable of $0.5 million.

Previous wording

Cash provided by operating activities for thenine months ended September 30, 2024 was$23.3 million and consisted of net income of approximately$11.0 million, adjusted for non-cash items of approximately$15.1 million, including stock-based compensation of $6.5 million, depreciation and amortization of $8.7 million and provision for credit loss of $0.1 million. Total changes in cash flows from operations were due to a decrease in working capital, primarily related to an increase in accounts receivable of approximately $6.7 million (primarily sales to China) and a decrease in accrued expenses and other of approximately $2.1 million, partially offset by a decrease in inventory of $4.4 million (primarily sales to China) and a decrease in prepaid expenses and other of $2.4 million.

Current wording

Cash provided by operating activities for the three months ended March 31, 2024 was $11.2 million and consisted of a net loss of approximately $4.8 million, adjusted for non-cash items of approximately $5.4 million, including stock-based compensation of $2.4 million, depreciation and amortization of $2.9 million and provision for credit loss of $0.1 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accounts receivable, net of approximately $23.1 million and an increase in accounts payable of approximately $2.1 million, partially offset by a decrease in accrued expenses and other of approximately $15.0 million.

Previous wording

Cash used in investing activities for thenine months ended September 30, 2024 was approximately$18.1 million, compared to net cash used in investing activities of approximately$11.0 million for the same period in 2023. Cash used in investing activities was primarily due to the purchase of available-for-sale securities of approximately $61.0 million, offset by the maturity of available-for-sale securities of approximately $42.9 million.

Current wording

Cash provided by investing activities for thethree months ended March 31, 2025 was approximately$1.5 million, compared to net cash used in investing activities of approximately$19.1 million for the same period in 2024. Cash provided by investing activities for the three months ended March 31, 2025 was primarily due to maturity of available-for-sale securities of approximately $14.1 million, partially offset by the purchase of available-for-sale securities of approximately $12.5 million.

Previous wording

Cash used in investing activities for the nine months ended September 30, 2023 was approximately $11.0 million. Cash used in investing activities was primarily due to the purchase of the intangible asset of $12.5 million, and the purchase of available-for-sale securities of approximately $12.5 million, offset by the maturity of available-for-sale securities of approximately $14.2 million for the nine months ended September 30, 2023.

Current wording

Cash used in investing activities for the three months ended March 31, 2024 was approximately $19.1 million. Cash used in investing activities for the three months ended March 31, 2024 was primarily due to the purchase of available-for-sale securities of approximately $25.0 million, offset by the maturity of available-for-sale securities of approximately $5.9 million.

Previous wording

Cash used in financing activities for the nine months ended September 30, 2024 was approximately $22.5 million. Of this amount, $22.7 million related to the payment of principal, as well as exit fees, on our debt with Athyrium, partially offset byapproximately $0.2 million of proceeds from employee stock options exercised.

Current wording

Cash used in financing activities for the three months ended March 31, 2025 was approximately $11.3 million, including $11.1 million related to the payment of principal and $0.2 million related exit fees, on our debt with Athyrium.

Previous wording

There was no cash provided by or used in financing activities for the nine months ended September 30, 2023.

Current wording

There was no cash provided by or used in financing activities for the three months ended March 31, 2024.

Previous wording

We issued senior notes for an aggregate principal amount of $100.0 million pursuant to the note purchase agreement dated July 23, 2021, by us, and our subsidiaries, and Athyrium, as Administrative Agent, and certain other investor parties (the “Note Purchase Agreement”), with an initial maturity date of July 23, 2026 (the “Athyrium Notes”). The Athyrium Notes were issued for face amount of $100.0 million net of an original issue discount of $1.5 million. The Athyrium Notes also require a 2.0% exit payment to be made on each payment of principal. The borrowings under the Athyrium Notes, together with cash on hand, were used to repay our outstanding indebtedness, including the applicable exit and prepayment fees owed to lenders under our prior Oxford Credit Facility. The Athyrium Notes are secured by substantially all of our assets. We incurred $1.9 million of deferred financing costs with the initial borrowing of the Athyrium Notes.

Current wording

We issued senior notes for an aggregate principal amount of $100.0 million pursuant to the note purchase agreement dated July 23, 2021 by us, and our subsidiary, and Athyrium, as Administrative Agent, and certain other investor parties (the “Note Purchase Agreement”), with an initial maturity date of July 23, 2026 (the “Athyrium Notes”). The Athyrium Notes were issued for face amount of $100.0 million net of an original issue discount of $1.5 million. The Athyrium Notes also require a 2.0% exit payment to be made on each payment of principal. The borrowings under the Athyrium Notes, together with cash on hand, were used to repay our outstanding indebtedness, including the applicable exit and prepayment fees owed to lenders under our prior credit facility with Oxford. The Athyrium Notes are secured by substantially all of our assets. We incurred $1.9 million of deferred financing costs with the initial borrowing of the Athyrium Notes.

Previous wording

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”). The modification of the Note Purchase Agreement pursuant to the Third Amendment did not meet the requirements of a debt extinguishment under ASC 470-50 -Debt Modifications and Exchanges and no gain or loss was recognized. We performed a quantitative analysis and determined that the terms of the new debt and original debt instrument are not substantially different. Accordingly, the Third Amendment is accounted for as a debt modification.

Current wording

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”).

Previous wording

At our option, we may prepay the outstanding principal balance of the notes in whole or in part, subject to a prepayment fee of 2.0% of the amount prepaid if the prepayment occurs on or prior to the second anniversary of the issuance date of such notes, plus the present value of remaining interest that would have accrued through and including the second anniversary date, and 2.0% of the amount prepaid if the prepayment occurs after the second anniversary but on or prior to the third anniversary of the issuance date of such notes.

Current wording

As of March 31, 2025, we may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

Previous wording

The Athyrium Notes include affirmative and negative covenants applicable to us. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage, and satisfy certain requirements regarding deposit accounts. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions. We are also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis.

Current wording

The Athyrium Notes include affirmative and negative covenants applicable to us. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage, and satisfy certain requirements regarding deposit accounts. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions. We are also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis. As of March 31, 2025, we were in compliance with such covenants.

Previous wording

As of September 30, 2024, the principal balance outstanding under the Athyrium Notes was $77.8 million representing all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

Current wording

As of March 31, 2025, the principal balance outstanding under the Athyrium Notes was $55.6 million and represents all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

Previous wording

We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization. These efforts will require funding in addition to the cash and cash equivalents totaling approximately $67.3 million and approximately $29.5 million in marketable securities available at September 30, 2024. While our consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of September 30, 2024, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

Current wording

We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization. These efforts will require funding in addition to the cash and cash equivalents totaling approximately $63.0 million and approximately $30.1 million in marketable securities available at March 31, 2025. While our consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of March 31, 2025, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

Previous wording

In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net (loss) income and net (loss) income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three and nine months ended September 30, 2024, stock-based compensation represented approximately 7.0% and 6.3% of our operating expenses, respectively, compared to 7.4% and 7.3% for the same respective periods in 2023, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Current wording

In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net income (loss) and net income (loss) per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three months ended March 31, 2025, stock-based compensation represented approximately 6.4% of our operating expenses, compared to 6.7% for the same period in 2024, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Previous wording

Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted Net (Loss) Income and

Current wording

Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and

Previous wording

GAAP Net (Loss) Income Per Share to Non-GAAP Adjusted Net (Loss) Income Per Share

Current wording

GAAP Net Income (Loss) Per Share to Non-GAAP Adjusted Net Income (Loss) Per Share

Previous wording

(3) Non-GAAP adjusted basic net income per share was calculated based on 49,008,464 and 48,498,579 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

Current wording

(3) Non-GAAP adjusted basic net income (loss) per share was calculated based on 49,595,697 and 48,189,256 weighted-average shares of common stock outstanding for the three months ended March 31, 2025 and 2024, respectively.

Previous wording

(5) Non-GAAP adjusted diluted net income per share was calculated based on 49,173,361 and 49,025,103 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

Current wording

(4) Non-GAAP adjusted diluted net income per share was calculated based on 49,906,341 weighted-average shares of common stock outstanding for the three months ended March 31, 2025.