HER2 Positive Breast Cancer

STAFFORD, Texas, March 13, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to June 30, 2025 which is approximately 57 months from date of the Company's IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors. About Flamingo-01 and GLSI-100 Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on Flamingo-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, Flamingo-01. For more information on Greenwich LifeSciences, please visit the Company's website at and follow the Company's Twitter at . Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2022 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com

The annual San Antonio Breast Cancer meeting drew clinicians and researchers for a few days at the end of 2023 to discuss advances in the field. While the past several decades have seen progress in early detection, recent innovations in metastatic breast cancer—or cancer that has spread to distant parts of the body, including the bone, brain, or lungs—continues to cause excitement. In the US, around 40,000 women and 4,000 men are diagnosed annually with metastatic breast cancer, and around 200,000 Americans are living with advanced disease. But nearly 300,000 US citizens are diagnosed with breast cancer annually, and the specter of this non-metastatic disease converting to metastatic disease amplifies the weight of this issue. Two thirds of all breast cancer patients have a type of breast cancer called hormone receptor-positive (HR+). For these patients, a key part of treatment has been reducing the activity of hormones like estrogen, which fuel the growth of cancer cells. In 2017, the standard treatment approach changed to include the use of one of three drugs called CDK4/6 inhibitors – abemaciclib (brand name: Verzenio), ribociclib (brand name: Kisqali), or palbociclib (brand name: Ibrance). These drugs are used alongside other medications that modify hormone levels, such as letrozole or fulvestrant. These drugs have improved both PFS (progression free survival or the time until disease starts to grow again) as well as the overall survival of patients, although that is much more modest and the 5 year survival rate for this class hovers around 30%. Unfortunately, many patients appear to be intrinsically resistant to these therapies and gain no benefit at all, and most others acquire resistance with time, forcing the field to reckon what is next in the post CDK4/6 inhibitor space? While there have been advances in developing drugs that can adjust hormone levels, they haven’t led to significant improvements in how long people live with the disease. As a result, there’s still a need for new therapies that can make a bigger difference in improving survival rates. But the field is responding and several new medicines have entered clinical usage in the last few years, with the goal of providing additional choices to delay the use of chemotherapy and increase overall survival. The consensus now is that these CDK4/6 inhibitor resistant breast cancer patients should be screened for several genetic perturbations, which are now actionable in terms of novel therapies. Olaparib, capivasertib or everolimus are all new additions to the post CDK4/6 inhibitor arsenal. This use of precision oncology screening in the breast cancer space reinforces the observation that not all metastatic disease is the same and this heterogeneity requires understanding on a per-patient level and therapies may have to be administered sequentially as disease evolves. Even when a patient needs to move to chemotherapy, for many, a less toxic option may now be available. Enhertu is an antibody drug conjugate (ADC), or a chemotherapy linked to an antibody that recognizes the Her2 receptor. This therapy was approved with great fanfare as it helps target the chemotherapy to the Her2+ tumor cell and has been shown to reduce toxicity relative to the untethered chemotherapy. Many CDK4/6 inhibitor resistant patients have now been reclassified as eligible for this therapy with the advent of a new biomarker designation, Her2 low. Of course, all of these new therapies carry potential adverse effects with them, and that is part of the reason for the robust pipeline of new therapies in the phase one clinical trial or preclinical setting. The clinical resistance seen with the CDK4/6 inhibitors appears to be due at least in part to the activation of a previously undrugged target, CDK2. While the field has tried unsuccessfully for several decades to drug CDK2, new more specific CDK2 monotherapies have entered phase one (Ph1a) trials over the last year (Pfizer, Blueprint Medicine, Incyclix, Incyte). The CDK2 monotherapies may have more limited response due to observations that both CDK4/6 and CDK2 have to be inhibited simultaneously, so there is effort to combine them with either existing CDK4/6 inhibitors such as Ibrance or new, more untested CDK4 inhibitors: Pfizer is testing a new CDK2 and CDK4 inhibitor combination and Beigene will begin testing of their new monotherapy combinations. The incredible focus in the drug-resistant breast cancer space will likely drive the development of therapies that will ultimately cross over into usage in other tumor types. For example, the Destiny trial last year demonstrated that Enhertu, which was originally developed for and approved in a different form of breast cancer, Her+ BC, showed response in numerous other tumor types, including uterus, cervix, ovaries, bladder, which were Her2+ paving a way for its broader use. A second observation is the sequencing of these new therapies combined with biomarker analysis, or identifying additional actionable targets in each patient, will be important to continually add to the therapeutic pipeline for patients. Creating a repertoire of add-on possibilities should help reduce the stigma of metastatic breast cancer as a terminal disease. Public domain image by the National Cancer Institute

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2023. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2023 compared to the fourth quarter and full year 2022. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2023 was $53.2 million, compared to $53.7 million in the fourth quarter of 2022. Product revenue, net for the full year 2023 was $203.1 million, compared to $200.0 million in 2022. Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $12.3 million, or $0.26 per basic and diluted share, for the fourth quarter of 2023, compared to a net loss of $5.6 million, or $0.12 per basic and diluted share, for the fourth quarter of 2022. Net income for full year 2023 was $21.6 million, or $0.46 per basic share and $0.45 per diluted share, compared to a net income of $2,000, or $0.00 per basic and diluted share, for full year 2022. Non-GAAP adjusted net income was $14.8 million, or $0.31 per basic and diluted share, for the fourth quarter of 2023, compared to non-GAAP adjusted net loss of $3.0 million, or $0.07 per basic and diluted share, for the fourth quarter of 2022. Non-GAAP adjusted net income for full year 2023 was $31.8 million, or $0.68 per basic share and $0.67 per diluted share, compared to non-GAAP adjusted net income of $11.8 million, or $0.26 per basic and diluted share, for full year 2022. Non-GAAP adjusted net income/loss excludes stock-based compensation expense. For a reconciliation of GAAP net income/loss to non-GAAP adjusted net income/loss and GAAP net income/loss per share to non-GAAP adjusted net income/loss per share, please see the financial tables at the end of this news release. Net cash provided by operating activities for the fourth quarter of 2023 was $10.4 million, compared to $7.7 million for the fourth quarter of 2022. Net cash provided by operating activities for full year 2023 was $27.0 million, compared to net cash used in operating activities of $15.8 million for full year 2022. At December 31, 2023, Puma had cash, cash equivalents, and marketable securities of $96.0 million, compared to cash, cash equivalents, and marketable securities of $81.1 million at December 31, 2022. “We are pleased to report positive net income for both the fourth quarter and full year 2023,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “NERLYNX sales in the fourth quarter were negatively impacted by the lower enrollments seen in Q3, as well as a higher than expected gross to net for the quarter. We have continued to reduce our internal expenses to account for this higher gross to net and lower Q3 enrollments, as we recognize our fiscal responsibility to continue to be net income positive in 2024. Puma also continues to execute on the clinical development of alisertib, and in February, we were pleased to initiate ALISertib in CAncer (ALISCA-Lung1), a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.” Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) presentation of biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor positive, HER2-negative breast cancer (H1 2024); (ii) updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non small cell lung cancer who have developed osimertinib resistance (H1 2024); (iii) initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024); and (iv) interim data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2024).” Revenue Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2023, total revenue was $72.2 million, of which $53.2 million was product revenue, net, and $19.0 million was royalty revenue. This compares to total revenue of $65.7 million for the fourth quarter of 2022, of which $53.7 million was product revenue, net, and $12.0 million was royalty revenue. For the year ended December 31, 2023, total revenue was $235.6 million, of which $203.1 million was product revenue, net, and $32.5 million was royalty revenue. This compares to total revenue in 2022 of $228.0 million, of which $200.0 million was product revenue, net, and $28.0 million was royalty revenue. Operating Costs and Expenses Total operating costs and expenses were $57.4 million for the fourth quarter of 2023, compared to $55.7 million for the fourth quarter of 2022. Total operating costs and expenses were $203.0 million for full year 2023, compared to $204.3 million for full year 2022. Cost of Sales Cost of sales was $24.3 million for the fourth quarter of 2023, compared to $16.8 million for the fourth quarter of 2022. Cost of sales was $62.7 million for full year 2023, compared to cost of sales of $55.1 million for full year 2022. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses were $20.2 million for the fourth quarter of 2023, compared to $25.1 million for the fourth quarter of 2022. SG&A expenses for full year 2023 were $89.9 million, essentially unchanged from $90.0 million for full year 2022. The slight increase includes an increase in payroll and related costs of approximately $3.5 million, primarily due to a one-time $2.0 million CARES Act credit in 2022, increased compensation of $1.5 million in 2023, and a $0.9 million credit loss reserve. These increases were offset by a decrease of $4.1 million in professional fees and expenses related to consultants and contractors, as well as lower insurance expenses and administrative costs. Research and Development Expenses Research and development (R&D) expenses were $12.9 million for the fourth quarter of 2023, compared to $13.8 million for the fourth quarter of 2022. R&D expenses for full year 2023 were $50.4 million, compared to $52.2 million for full year 2022. The $1.8 million decrease in R&D expenses during full year 2023 compared to full year 2022 resulted primarily from the reduction and closure of NERLYNX clinical trial sites of approximately $4.7 million, partially offset by an increase in internal R&D expenses of approximately $3.2 million, primarily due to a tax credit recorded during the year ended December 31, 2022 under the CARES Act, without a comparable tax credit in 2023. Acquired In-Process Research and Development Expense Puma recorded acquired in-process R&D expense related to an alisertib up-front payment of $7.0 million during the year ended December 31, 2022. No similar expenses were recorded in 2023. Total Other Income (Expenses) Total other expenses were $2.0 million for the fourth quarter of 2023, compared to $15.3 million for the fourth quarter of 2022. Total other expenses were $9.9 million for full year 2023, compared to $23.2 million for full year 2022. The $13.3 million decrease in other expenses in full year 2023 resulted primarily from legal verdict expenses recorded in 2022, with no similar accruals in 2023, as well as an increase in other income related to higher interest rates in 2023. First Quarter 2024 and Full Year 2024 Financial Outlook First Quarter 2024 Full Year 2024 Net Product Revenue $38 - $40 million $183 - $190 million Royalty Revenue $2.5 - $3 million $30 - $33 million License Revenue $0 million $1 - $2 million Net Income/(Loss) $(10) - $(12) million $12 - $15 million Gross to Net Adjustment 23% - 24% 21.5% - 22.5% Conference Call Puma Biotechnology will host a conference call to discuss its fourth quarter and full year 2023 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 29, 2024. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at or by calling 1-855-816-5421. Further information about Puma Biotechnology may be found at . INDICATIONS NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication CONTRAINDICATIONS: None WARNINGS AND PRECAUTIONS: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction. Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities. Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were as follows: NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or . DRUG INTERACTIONS: Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids. Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX. USE IN SPECIFIC POPULATIONS: Lactation: Advise women not to breastfeed. Please see Full Prescribing Information for additional safety information. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and estimates of future financial results for the first quarter and full year 2024. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) Revenues: Product revenue, net $ 53.2 $ 53.7 203.1 $ 200.0 License revenue — — — — Royalty revenue 19.0 12.0 32.5 28.0 Total revenue 72.2 65.7 235.6 228.0 Operating costs and expenses: Cost of sales 24.3 16.8 62.7 55.1 Selling, general and administrative 20.2 25.1 89.9 90.0 Research and development 12.9 13.8 50.4 52.2 Acquired in-process research and development — — — 7.0 Total operating costs and expenses 57.4 55.7 203.0 204.3 Income from operations 14.8 10.0 32.6 23.7 Other income (expenses): Interest income 0.7 0.6 2.6 0.8 Interest expense (3.3 ) (3.3 ) (13.3 ) (11.5 ) Legal verdict (expense) credit — (12.4 ) — (12.5 ) Other income (expense) 0.6 (0.2 ) 0.8 — Total other expenses (2.0 ) (15.3 ) (9.9 ) (23.2 ) Net income (loss) before income taxes 12.8 (5.3 ) 22.7 0.5 Income tax expense (0.5 ) (0.3 ) (1.1 ) (0.5 ) Net income (loss) $ 12.3 $ (5.6 ) $ 21.6 $ (0.0 ) Net income (loss) per share of common stock—basic $ 0.26 $ (0.12 ) $ 0.46 $ 0.00 Net income (loss) per share of common stock—diluted $ 0.26 $ (0.12 ) $ 0.45 $ 0.00 Weighted-average shares of common stock outstanding—basic 47,600,505 45,814,185 47,134,331 44,674,501 Weighted-average shares of common stock outstanding—diluted 48,040,118 45,814,185 47,550,852 44,929,998 PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES LIQUIDITY AND CAPITAL RESOURCES (in millions) December 31, December 31, 2023 2022 Cash and cash equivalents $ 84.6 $ 76.2 Marketable securities $ 11.4 $ 4.9 Working capital $ 56.8 $ 56.8 Short term debt $ 34.0 — Long term debt $ 65.7 $ 98.3 Stockholders' deficit $ 53.4 $ 21.6 Twelve Months Twelve Months Ended Ended December 31, December 31, 2023 2022 Cash provided by (used in): Operating activities $ 27.0 $ (15.8 ) Investing activities (19.1 ) 7.1 Financing activities — 12.2 Increase (decrease) in cash and cash equivalents, and restricted cash $ 7.9 $ 3.5 Use of Non-GAAP Measures In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents Puma’s net income (loss) and net income (loss) per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and twelve months ended December 31, 2023, stock-based compensation represented approximately 7.4% and 7.3% of operating expenses, respectively, and 6.8% and 8.3% for the same periods in 2022, in each case excluding cost of sales and acquired in-process research and development. Puma’s management believes that these non-GAAP financial measures are useful to enhance understanding of Puma’s financial performance, are more indicative of its 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. PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and GAAP Net Income (Loss) Per Share to Non-GAAP Adjusted Net Income (Loss) Per Share (in millions except share and per share data) (Unaudited) Three Months Ended December 31, 2023 2022 GAAP net income (loss) $ 12.3 $ (5.6 ) Adjustments: Stock-based compensation - Selling, general and administrative 1.5 1.8 (1) Research and development 1.0 0.8 (2) Non-GAAP adjusted net income (loss) $ 14.8 $ (3.0 ) GAAP net income (loss) per share—basic $ 0.26 $ (0.12 ) Adjustment to net income (loss) (as detailed above) 0.05 0.05 Non-GAAP adjusted basic net income (loss) per share $ 0.31 (3) $ (0.07 ) (3) GAAP net income (loss) per share—diluted $ 0.26 $ (0.12 ) Adjustment to net income (loss) (as detailed above) 0.05 0.05 Non-GAAP adjusted diluted net income (loss) per share $ 0.31 (4) $ (0.07 ) (5) Twelve Months Ended December 31, 2023 2022 GAAP net income (loss) $ 21.6 $ 0.0 Adjustments: Stock-based compensation - Selling, general and administrative - 8.0 (1) Research and development - 3.8 (2) Non-GAAP adjusted net income $ 21.6 $ 11.8 GAAP net income (loss) per share—basic $ 0.46 $ 0.00 Adjustment to net income (loss) (as detailed above) 0.22 0.26 Non-GAAP adjusted basic net income per share $ 0.68 (6) $ 0.26 (6) GAAP net income (loss) per share—diluted $ 0.45 $ 0.00 Adjustment to net income (loss) (as detailed above) 0.22 0.26 Non-GAAP adjusted diluted net income per share $ 0.67 (7) $ 0.26 (7) (1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation. (2) To reflect a non-cash charge to operating expense for research and development stock-based compensation. (3) Non-GAAP adjusted basic net income (loss) per share was calculated based on 47,600,505 and 44,814,185 weighted-average shares of common stock outstanding for the three months ended December 31, 2023 and 2022, respectively. (4) Non-GAAP adjusted diluted net income per share was calculated based on 48,040,118 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the three months ended December 31, 2023. (5) Potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) were not included in the non-GAAP adjusted diluted net loss as these shares would be considered anti-dilutive. (6) Non-GAAP adjusted basic net income per share was calculated based on 47,134,331 and 44,674,501 weighted-average shares of common stock outstanding for the years ended December 31, 2023 and 2022, respectively. (7) Non-GAAP adjusted diluted net income per share was calculated based on 47,550,852 and 44,929,998 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the years ended December 31, 2023 and 2022, respectively.