Q1 2026 Puma Biotechnology Inc Earnings Call

May 7, 2026

Operator: Good afternoon. My name is John, I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speaker's formal remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press the star key, then 1 on your telephone keypad. If you would like to withdraw your questions, please press star 2. If you should require operator assistance during the conference, please press star 0. As a reminder, this call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Thank you. You may begin your conference.

Mariann Ohanesian: Thank you, John. Good afternoon, and welcome to Puma's conference call to discuss our results for the first quarter of 2026. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology, Maximo Nougues, Chief Financial Officer, Heather Blaber, Senior Vice President of Marketing, and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing results for the first quarter of 2026. That news release, the slides that Alan and Roger will refer to, and a webcast to this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Mariann Ohanesian: After the close today, Puma issued a news release detailing results for the first quarter of 2026. That news release, the slides that Alan and Roger will refer to, and a webcast to this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Mariann Ohanesian: Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended 31 December 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, 7 May 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

Mariann Ohanesian: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, 7 May 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

Mariann Ohanesian: During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures. Please refer to our Q1 2026 release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Alan Auerbach: Thank you, Mariann, thank you all for joining our call today. Today, Puma reported total revenue for Q1 2026 of $44.8 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sub-licensees. Product revenue net was $42 million in Q1 2026, a decline from $59.9 million reported in Q4 2025 and $43.1 million reported in Q1 2025. As a reminder to investors, Puma's reported NERLYNX sales includes both US net sales and product supply revenues of NERLYNX to Puma's ex-US partners. Product revenue for Q1 2026 was impacted by approximately $7.9 million of inventory drawdown at our specialty pharmacies and specialty distributors.

Alan Auerbach: As a reminder to investors, Puma's reported NERLYNX sales includes both US net sales and product supply revenues of NERLYNX to Puma's ex-US partners. Product revenue for Q1 2026 was impacted by approximately $7.9 million of inventory drawdown at our specialty pharmacies and specialty distributors.

Alan Auerbach: Royalty revenue was $2.8 million in Q1 2026, compared to $15.6 million in Q4 2025 and $2.9 million in Q1 2025. As noted in our last call, royalty revenue in Q4 2025 was driven by the shipment to our partner in China. We reported 2,328 bottles of NERLYNX sold in Q1 2026, compared to 3,298 bottles sold in Q4 2025. In Q1 2026, we estimate that inventory decreased by 439 bottles.

Alan Auerbach: In Q1 2026, new prescriptions were up approximately 25% compared to Q4 2025. Total prescriptions were down approximately 4% compared to Q4 2025. Roger will provide further details in his comments and slides. I will now present the interim data from Puma's ongoing phase II trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as the ALISCA-Lung1 and ALISCA-Breast1 trials. Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activity. Maximo Nougues will follow with highlights of the key components of our financial statements for Q4 2025. We now move to the ALISCA-Lung interim presentation.

Alan Auerbach: I will now present the interim data from Puma's ongoing phase II trials of alisertib in small cell lung cancer and HER2-negative ER-positive breast cancer, also referred to as the ALISCA-Lung1 and ALISCA-Breast1 trials. Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activity. Maximo Nougues will follow with highlights of the key components of our financial statements for Q4 2025. We now move to the ALISCA-Lung interim presentation.

I will now present the interim data, from Puma's ongoing Phase 2, Trials of all assertive in small cell, lung cancer, and her 2 negative, ER, positive breast cancer. Also referred to as the alisco, lung 1 and Alisa breast 1 trials.

Heather blabber and Roger storms, will add additional color on nerlynx Commercial activity, maximum Noz. Well follow with highlights of the key components of our financial statements for the fourth quarter of 2025

To now, move to the Alisa lung interim, presentation.

Alan Auerbach: As a reminder, 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. The drug has also shown activity in previous clinical trials in peripheral T-cell lymphoma and non-Hodgkin's lymphoma. Takeda's previous clinical development program of alisertib was extensive, and due to this, there's a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials. From a preclinical perspective, it has been shown that Aurora kinase A and c-MYC upregulate each other, which suggests the existence of a positive feedback loop. c-MYC upregulates the cyclin complex, which leads to cell proliferation. By inhibiting Aurora kinase A with alisertib, it also inhibits c-MYC, which decreases cell proliferation.

Alan Auerbach: Takeda's previous clinical development program of alisertib was extensive, and due to this, there's a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials. From a preclinical perspective, it has been shown that Aurora kinase A and c-MYC upregulate each other, which suggests the existence of a positive feedback loop. c-MYC upregulates the cyclin complex, which leads to cell proliferation. By inhibiting Aurora kinase A with alisertib, it also inhibits c-MYC, which decreases cell proliferation.

As a reminder, in clinical trials, to date alerted has shown single agent activity and activity in combination with other Cancer drugs in the treatment of many different types of cancers, including Homer receptor, positive breast cancer, triple negative breast cancer, small cell, lung cancer, and head and neck, cancer. The drug is also shown activity in previous clinical trials in peripheral T-cell lymphoma and Non-Hodgkins Lymphoma.

To cada's previous clinical development program with Alice was extensive and due to this, there is a large, welcome characterized clinical safety database with over 1300 patients, who were treated across 22 company sponsored trials.

Alan Auerbach: Additionally, preclinical data has shown that alisertib inhibited growth of cells with c-MYC overexpression, and in xenograft models that expressed high levels of c-MYC, tumor growth was inhibited. Puma's Phase II trial, ALISCA-Lung1, which is also referred to as study PUMA-ALI-4201, was designed to enroll up to 60 patients with small cell lung cancer who had received prior treatment with a platinum-based chemotherapy and immunotherapy. The trial enrolls both second-line and third-line patients. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alisertib was initially dosed at 50 milligrams BID on days 1 to 7 of a 21-day cycle. As investors are aware, the trial was then amended to increase the dose to 60 milligram BID, and the company is now in the process of increasing the dose to 70 milligrams BID.

From a pre preclinical perspective, it has been shown that Aurora kinase, a, and cmic upregulate each other, which suggests the existence of a positive feedback loop. See, Mick upregulates, the Cyclone complex, which leads to self proliferation. So by inhibiting, Aurora kinase, a with alliser did it also inhibits semic which decreases cell proliferation

Additionally, pre-clinical data has shown that alliser inhibited growth of cells with cmic overexpression. And in graph models that expressed high levels of cmic tumor, growth was inhibited.

Alan Auerbach: The trial enrolls both second-line and third-line patients. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alisertib was initially dosed at 50 milligrams BID on days 1 to 7 of a 21-day cycle. As investors are aware, the trial was then amended to increase the dose to 60 milligram BID, and the company is now in the process of increasing the dose to 70 milligrams BID.

Puma's Phase 2, trial Alisa lung 1, which is also referred to. As study Puma, Ali 4201 was designed to enroll up to 60, patients with small cell, lung cancer who had received prior treatment with a platinum based chemotherapy and immunotherapy. The trial enrolls, both second line and third line patients.

Patients must provide tissue-based biopsies so that biomarkers can be analyzed.

Alan Auerbach: The primary endpoint of the trial is to determine whether any biomarker correlates with alisertib response with endpoints of overall response rate, duration of response, disease control rate, progression-free survival, and overall survival. The secondary endpoints include investigator-assessed efficacy and survival. Mandatory G-CSF prophylaxis is also given in the trial in an effort to reduce the neutropenia that was shown to be dose-limiting in the previous clinical trials with alisertib. Slide 6 shows the baseline characteristics for the 52 patients treated at 50 milligrams BID and the 27 patients treated at 60 milligrams BID that are included in this interim analysis. Slide 7 shows the summary of the prior treatments the patients received prior to entering the study. Of note, all of these patients were treated in either the second line or third line in this trial. To first discuss the safety in the trial.

Alice started with initially dosed at 50 milligrams, bid on Days, 1 to 7 of a 21 day cycle, as investors are aware of the trial with then, amended to increase the dose to 60 migram B. And the company is now in the process of increasing the dose to 70 milligrams, B.

The primary amp points of the trial is, to determine whether any biomarker correlates with allocative response with end points of or overall response rates duration of response Disease Control, rate progression, free survival, and overall survival.

The secondary end points include investigator assess efficacy and survival.

Mandatory gcsf prophylaxis is also given in the trial in an effort to reduce the neutropenia that was shown to be dose limiting and the previous clinical trials with alliser.

Alan Auerbach: Slide 6 shows the baseline characteristics for the 52 patients treated at 50 milligrams BID and the 27 patients treated at 60 milligrams BID that are included in this interim analysis. Slide 7 shows the summary of the prior treatments the patients received prior to entering the study. Of note, all of these patients were treated in either the second line or third line in this trial. To first discuss the safety in the trial.

By 6 shows the baseline characteristics for the 52 patients treated at 50 mg BID and the 27 patients treated at 60 mg BID that are included in this interim analysis.

Slide 7 shows the summary of the prior treatments the patients received before entering the study. Of note, all of these patients were treated in either the second line or third line in this trial.

To First discuss the safety in the trial.

Alan Auerbach: In previous clinical trials of alisertib, the treatment-emergent adverse events seen were those characteristic of a cell cycle inhibitor, with neutropenia being the main AE seen in the highest percentage. In this trial, the all-grade neutropenia was 19.2% in the 50-milligram arm and 22% in the 60-milligram arm. Slide 10 shows the rates of Grade 3 and 4 AEs seen in the trial. Of note, the Grade 3 or higher neutropenia rate was 13.5% in the 50-milligram arm and 11.1% in the 60-milligram arm. Slide 11 compares the Grade 3 and Grade 4 AE rates seen in the ALISCA™-Lung1 trial to those that were seen in the previous phase II trial of alisertib monotherapy in small cell lung cancer, referred to as study C14007.

In previous clinical trials valid the treatment of emergent Adverse Events seen where those characteristic of a cell cycle. Inhibitor with neutropenia being the main AE seen in the highest percentage in this trial. The all grade neutropenia was 19.2% in the 50 milligram arm and 22% in the 60 migram R.

Alan Auerbach: Slide 10 shows the rates of Grade 3 and 4 AEs seen in the trial. Of note, the Grade 3 or higher neutropenia rate was 13.5% in the 50-milligram arm and 11.1% in the 60-milligram arm. Slide 11 compares the Grade 3 and Grade 4 AE rates seen in the ALISCA™-Lung1 trial to those that were seen in the previous phase II trial of alisertib monotherapy in small cell lung cancer, referred to as study C14007.

Alan Auerbach: C14007 was previously published in Lancet Oncology in 2010. As a reminder, in C14007, G-CSF prophylaxis was not mandated, while ALISCA Lung 1 requires mandatory prophylactic G-CSF. As can be seen on the slide, the use of prophylactic G-CSF appeared to reduce the rates of Grade 3 or higher neutropenia compared to what was seen in the previous trial. The next moves to the efficacy seen in the trial. As you can see in slide 13, in the 52 patients in ALISCA Lung 1 that were treated at 50 mg, we have seen 4 patients or 11.5% with a best response of a partial response and 18 patients or 34.6% with stable disease. The median PFS for the 50 mg arm was 1.7 months.

Slide 11 compared to grade 3 and grade 4ae rates. Seen in the Alisa lung 1 trial to those that were seen in the previous Phase 2 trial of Alice. Cert of monotherapy and small cell lung cancer referred to as studies seed, 140007 c14 007 was previously published in Lancet, oncology in 2010.

As a reminder, in c14 007 gcsf prophylaxis was not mandated while Liska. Lung 1 requires mandatory prophylactic gcsf.

As can be seen on the slide, the use of prophylactic GCSF appears to reduce the rates of grade 3 or higher neutropenia compared to what was seen in the previous trial.

Alan Auerbach: The next moves to the efficacy seen in the trial. As you can see in slide 13, in the 52 patients in ALISCA Lung 1 that were treated at 50 mg, we have seen 4 patients or 11.5% with a best response of a partial response and 18 patients or 34.6% with stable disease. The median PFS for the 50 mg arm was 1.7 months.

The next move to the efficacy seen in the trial.

Alan Auerbach: In the first 15 patients in the 60-milligram arm, we have seen 1 patient or 6.7% with a best response of a partial response, and 7 patients or 46.7% with stable disease. The median PFS for the 60-milligram arm is currently 4.2 months. Slide 14 shows the Kaplan-Meier curve for PFS between the 50-milligram and 60-milligram arm of the trial. As previously stated, the median PFS of the 60-milligram arm is currently 4.2 months. However, we caution it is still early and we await additional patient numbers and additional follow-up. We will now move to the biomarkers in the trial. Slide 16 presents the Kaplan-Meier curve for the patients according to c-MYC H-score.

As you can see in slide 13, in the 52 patients—and a list—go along 1 that were treated at 50 mg. We have seen 4 patients, or 11.5%, with a best response of a partial response, and 18 patients, or 34.6%, with stable disease. The median PFS for the 50 milligram arm was 1.7 months.

In the first 15 patients in the 60 migram arm. We have seen 1 patient or 6.7% with a best response of a partial response and 7 patients or 46.7% with stable disease. The median PFS for the 60 milligram arm is currently 4.2 months.

Alan Auerbach: As previously stated, the median PFS of the 60-milligram arm is currently 4.2 months. However, we caution it is still early and we await additional patient numbers and additional follow-up. We will now move to the biomarkers in the trial. Slide 16 presents the Kaplan-Meier curve for the patients according to c-MYC H-score.

Slide 14, shows the Kaplan Meier curve for PFS between the 50 milligram and 60 milligram arm on the trial as previously stated the median. PFS with a 16 milligram arm is currently 4.2 months. However, we caution it is still early and we await additional patient numbers and additional follow-up.

We will now move to the biomarkers in the trial.

Alan Auerbach: c-MYC H-score is a semi-quantitative immunohistochemical assessment that measures the intensity and percentage of tumor cells staining for the c-MYC protein, typically ranging from 0 to 300. High c-MYC H-scores are believed to be associated with poor prognosis and lower overall survival in various cancers. As you can see on slide 16, for the combined doses of 50 milligrams and 60 milligrams, patients with c-MYC H-score of between 0 and 100 had a median PFS of 1.68 versus a PFS of 4.17 for the patients with a c-MYC H-score of between 101 and 300. This would suggest that alisertib has better activity in cancers with a higher amount of c-MYC activity.

Slide 16 presents the Kaplan Meier curve for the patients according to cmic 8 score.

Alan Auerbach: As you can see on slide 16, for the combined doses of 50 milligrams and 60 milligrams, patients with c-MYC H-score of between 0 and 100 had a median PFS of 1.68 versus a PFS of 4.17 for the patients with a c-MYC H-score of between 101 and 300. This would suggest that alisertib has better activity in cancers with a higher amount of c-MYC activity.

Cmic H score is a semi-quantitative Amino, histochemical assessment that measures the intensity and percentage of tumor cells staining for the cmic protein. Typically ranging from 0 to 300, High cmic. H scores are believed to be associated with poor, prognosis and lower overall survival in various cancers.

As you can see, on slide 16 for the combined doses of 50 milligrams and 60 milligrams, patients with semic h score of between 0 and 100, had a median, PFS of 1.68 versus a, PFS of 4.17 for the patients, with a seam mixed score of between, uh, cmx score, a score of between 101 and 300. This would suggest that allocative has better activity in cancers with a higher amount of cmic activity.

Alan Auerbach: Slide 17 presents the KM curve for the 50-milligram and 60-milligram dose separately for the patients according to c-MYC H-score. As you can see on the slide, for the 50-milligram dose, patients with H-score of between 0 and 100 had a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with a c-MYC score of between 101 and 300. For the 60-milligram dose, patients with H-score of between 0 and 100 had a median PFS of 1.41 months, while the median PFS has not yet been reached for the patients with c-MYC H-score of 101 to 300.

Alan Auerbach: We believe that these slides are suggesting that alisertib has greater activity in tumors with higher c-MYC H-scores and hence more c-MYC activity, which we believe is due to the inhibition of the aurora kinase pathway by alisertib. Slide 18 presents the KM curve for the patients according to percent of tumor cells that are c-MYC positive. As you can see on slide 18, for the combined doses of 50 milligram and 60 milligram, for tumors having between 0% and 10% of the cell c-MYC positive, there's a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with tumors having between 11% and 100% of the cells c-MYC positive. Slide 19 presents the KM curve for the 50-milligram and 60-milligram doses separately for the patients according to the percent of tumor cells that are c-MYC positive.

Slide 17 presents the cmic that presents the km curve for the 50 milligram and 60 milligram dose separately for the patients according to cmic hore as you can see on the slide for the 50 milligram dose patients with h score of between 0 and 100, had a median, PFS of 1.68 months versus a, PFS of 2.83 months for the patients with a c, mix score between 101 and 300 while for the 60 mg dose patients with a score of between 0 and 100. Had a median, PFS of 1.41 months while the median PFS has not yet, been reached for the patients with cmic HC, score of 101 to 300. We believe that these slides are suggesting that Alice has greater activity and tumors with higher cmic, H scores and Hench, more seemic activity, which we believe is due to the inhibition of the Aurora counties pathway by Alice cert.

Alan Auerbach: As you can see on slide 18, for the combined doses of 50 milligram and 60 milligram, for tumors having between 0% and 10% of the cell c-MYC positive, there's a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with tumors having between 11% and 100% of the cells c-MYC positive. Slide 19 presents the KM curve for the 50-milligram and 60-milligram doses separately for the patients according to the percent of tumor cells that are c-MYC positive.

Slide 18 presents the KM curve for the patients, according to the percent of tumor cells that are c-Met positive. As you can see on slide 18, for the combined doses of 50 milligrams and 60 milligrams, for tumors having between 0 and 10% of the cells c-Met positive, there's a median PFS of 1.68 months versus a PFS of 2.83 months for the patients with tumors having between 11 and 100% of the cells c-Met positive.

Alan Auerbach: As you can see on the slide, for the 50-mg dose, patients with tumors having between 0% and 10% of the cells c-MYC positive had a median PFS of 1.68 months versus a PFS of 2.73 months for patients with tumors having between 11% and 100% of the tumor cells c-MYC positive. While for the 60-mg dose, between 0% and 10% of c-MYC positive had a median PFS that has not been reached versus a PFS of 4.17 months for the patients with between 11% to 100% of the tumor cells c-MYC positive.

Slide 19, presents the km curve for the 50 milligram and 60 milligram doses. Separately for the patients, according to the percent of tumor cells that are seen make positive. As you can see on the slide for the 50 milligram dose patients with tumors having between 0 and 10% of the cells cumic positive. Had a median PFS of 1.68 months versus a, PFS of 2.73 months for patients with tumors having between 11 and 100% of the tumor cells, same like positive.

Well, for the 60-milligram dose, between—

Alan Auerbach: We believe that these slides are suggesting that alisertib has greater activity in the tumors where a higher percentage of the cells are c-MYC positive, which we again believe is due to the inhibition of the Aurora kinase pathway by alisertib. We believe that the initial clinical data with alisertib in small cell lung cancer are demonstrating that alisertib is showing better activity in patients where c-MYC is playing a role in driving the tumor, which is indicative of tumors where Aurora kinase A is activated. There are currently 32 patients enrolled in the 60mg arm of the trial. Based on this preliminary safety seen at this dose, we are continuing to dose escalate to 70mg, and we hope to begin enrollment of the 70mg cohort in H2 2026.

To 100% of the tumor cells, seems like positive,

We believe that these slides are suggesting that Alice has greater activity in the tumors where a higher percentage of the cells are c-Myc positive, which we again believe is due to the inhibition of the Aurora kinase pathway by Alice.

We believe that the initial clinical data with Alice certum in small cell, lung, cancer are demonstrating

Alan Auerbach: There are currently 32 patients enrolled in the 60mg arm of the trial. Based on this preliminary safety seen at this dose, we are continuing to dose escalate to 70mg, and we hope to begin enrollment of the 70mg cohort in H2 2026.

Alan Auerbach: We believe that the data generated thus far in ALISCA™-Lung1 is showing that alisertib monotherapy is showing a PFS at higher doses and in certain biomarker-directed populations that is as good or slightly better than the PFS for currently approved drugs in this space. As discussed previously, we are hopeful that with increasing doses of alisertib monotherapy in ALISCA™-Lung1, we can achieve higher concentrations of alisertib in these biomarker-defined populations and potentially open up the opportunity for a phase III design that tests alisertib monotherapy in a randomized trial. As investors are aware, alisertib was previously tested in a randomized phase II trial of paclitaxel plus alisertib versus paclitaxel plus placebo, where a PFS and OS benefit was seen in patients with tumors with biomarkers that appear to indicate that the Aurora kinase A pathway was activated.

That Alice started this showing better activity in patients, where C make is playing a role in driving the tumor which is indicative of tumors where Aurora canis a is activated. There are currently 32 patients enrolled in the 60 mg arm of the trial based on this preliminary safety, seen at this dose, We are continuing to dose escalate to 70 mg and we hope to begin enrollment of the 70 mg cohort in the second half of 2026.

Alan Auerbach: As investors are aware, alisertib was previously tested in a randomized phase II trial of paclitaxel plus alisertib versus paclitaxel plus placebo, where a PFS and OS benefit was seen in patients with tumors with biomarkers that appear to indicate that the Aurora kinase A pathway was activated.

higher Doses, and in certain bioarkive,

Alan Auerbach: Based on this data and the data from ALISCA™-Lung1, Puma will be looking to a dual approach for the development of alisertib in small cell lung cancer. In addition to the monotherapy dose escalation approach in ALISCA™-Lung1, Puma will also be looking to initiate ALISCA™-Lung2, which will investigate the efficacy of alisertib given in combination with paclitaxel using mandatory G-CSF prophylaxis. We are hoping to initiate this trial in H2 of 2026. We are pleased with the interim data from ALISCA™-Lung1, and we believe it is showing an improved tolerability profile for alisertib monotherapy and improved efficacy with dose escalation as well as improved efficacy in a biomarker-directed population that is indicative of the Aurora kinase pathway activation.

Investors are aware how assertive was previously, tested and a randomized, phase 2 trial of Pac with taxol plus all assertive versus pacel plus PBO where a PFS and Os benefit was seen in patients with tumors with biomarkers that appeared to indicate that the Aurora canex a pathway was activated.

Based on this data and the data from ALIS-1, Puma will be looking to do a dual approach for the development of ALIS in both assertive and small cell lung cancer.

Alan Auerbach: We are hoping to initiate this trial in H2 of 2026. We are pleased with the interim data from ALISCA™-Lung1, and we believe it is showing an improved tolerability profile for alisertib monotherapy and improved efficacy with dose escalation as well as improved efficacy in a biomarker-directed population that is indicative of the Aurora kinase pathway activation.

Therefore, in addition to the monotherapy dose escalation approach and Alisa lung 1 Puma will also be looking to initiate initiate a list of lung 2, which will investigate the efficacy of all assertive. Given in combination with Pacquiao. Using mandatory gcsf prophylaxis, we are hoping to initiate this trial in the second half of 2026.

We are pleased with the interim data.

Alan Auerbach: We anticipate additional interim efficacy data from ALISCA-Lung1 in H2 2026 or H1 2027. I will now move to the ALISCA-Breast1 interim presentation. As a reminder, and as previously stated, 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 cancer, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer, and head and neck cancer. There's also a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials.

from a list of lung 1 and we believe it is showing an improved tolerability profile for alliser de monotherapy and improved efficacy with dose escalation as well as improved efficacy in a biomarker directed population that is indicative of the Aurora kinase pathway activation, we anticipate additional interim, efficacy data, from Alisa lung 1 and the second half of 2026 or the first half of 2027,

I will now move to the Alisa breast, 1, interim, presentation.

As a reminder, and as previously stated in clinical trials to date, I'll assertive has shown single agent activity and activity in combination with other Cancer drugs in the treatment of many different types of cancer, including home receptor positive breast cancer, triple negative breast cancer, small cell, lung cancer, and head and neck cancer.

Alan Auerbach: As previously stated, from a preclinical perspective, it has been shown that Aurora kinase A and c-MYC upregulate each other, which suggests the existence of a positive feedback loop. Preclinical data has shown that alisertib inhibited growth of cells with c-MYC overexpression and in xenograft models that expressed higher levels of c-MYC, tumor growth was inhibited. Puma's phase II ALISCA-Breast1, also referred to as study PUMA-ALI-1201, investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative, hormone receptor-positive, recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting and have had previous treatment with a CDK4/6 inhibitor and have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

There's also a large, well, characterized clinical safety database with over 1300 patients, who were treated across 22 company sponsored trials.

As previously stated from a pre-clinical perspective, it has been shown that Aurora kinase A and c-Myc upregulate each other, which suggests the existence of a positive feedback loop. Pre-clinical data has shown that alisertib inhibited growth of cells with c-Myc overexpression, and in xenograft models that expressed higher levels of c-Myc, tumor growth was inhibited.

Alan Auerbach: Puma's phase II ALISCA-Breast1, also referred to as study PUMA-ALI-1201, investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative, hormone receptor-positive, recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting and have had previous treatment with a CDK4/6 inhibitor and have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

Puma's Phase. 2 Alisa breast 1.

Also referred to as study Puma Ali 121 investigates Al assertive in combination with endocrine treatment. Consisting of either an asteroid XMS stain letrozol for vestron or tifin in patients, with her 2, negative hormone receptor, positive, recurrent, or metastatic breast cancer.

Alan Auerbach: Patients were dosed with alisertib given at either 30 milligrams, 40 milligrams, or 50 milligrams BID on days 1 to 3, 8 to 10, and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. The primary endpoints include objective response rate, duration of response, disease control, and progression-free survival. As a secondary objective, the company is evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, which might give the company the potential to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2 negative hormone receptor-positive breast cancer in these biomarker-specific populations.

Patients must be chemotherapy-naive in the recurrent or metastatic setting, and have had previous treatment with a CDK4/6 inhibitor, and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

Patients were dosed with aloe give it at either, 30 milligrams, 40, milligrams, or 50 milligrams bid on Days, 1 to 3, 8, to 10 and 15 to 17 on a 28-day cycle.

In combination with the endocrine therapy of investigators choice.

Patients must not have been previously treated with the endocrine treatment and the metastatic setting that will be given in combination with alliser Tobin. The trial.

Alan Auerbach: As a secondary objective, the company is evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, which might give the company the potential to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2 negative hormone receptor-positive breast cancer in these biomarker-specific populations.

The primary end points include objective response rates duration of response Disease, Control and progression fee survival. As a secondary objective, the company is evaluating each of these efficacy endpoints within biomarkers, subgroups in order to determine whether any biomarker, subgroup correlates with better efficacy, which might give the company the potential to focus the future of the clinical development of Alice. Cert in combination, with endocrine therapy for patients with her2 negative hormone receptor.

Positive breast cancer in these biomarkers specific populations.

Alan Auerbach: Slide 25 shows the baseline characteristics for the 164 patients included in this interim analysis. As the slide shows, the majority of these patients were treated in the 3rd line or later setting. First, discuss the safety in the trial. As previously mentioned, in previous clinical trials of alisertib, the treatment-emergent adverse events seen were those characteristic of a cell cycle inhibitor, with neutropenia being the AE seen in the highest percentage. Slide 27 shows that the rates of grade 3 or 4 AEs seen in the trial. Of note, the grade 3 or higher neutropenia rate was 8% in the 30-milligram arm, 10.2% in the 40-milligram arm, and 26.9% in the 50-milligram arm. It is important for investors to note that prophylactic G-CSF was not given in the study.

July, 25 shows the Baseline characteristics for the 164. Patients included in this interim analysis.

As the slide shows, the majority of these patients were treated in the third line or later setting.

First, discussed the safety in the trial.

Alan Auerbach: Slide 27 shows that the rates of grade 3 or 4 AEs seen in the trial. Of note, the grade 3 or higher neutropenia rate was 8% in the 30-milligram arm, 10.2% in the 40-milligram arm, and 26.9% in the 50-milligram arm. It is important for investors to note that prophylactic G-CSF was not given in the study.

As previously mentioned and previously, clinical trials of Al assertive, the treatment emergent Adverse Events. Seen were those characteristic of a cell cycle, inhibitor with neutropenia being the aec in the highest percentage.

Alarm 10.2% in the 40 mg arm and 26.9% in the 50 Mig arm. It is important for investors to note that prophylactic gcsf was not given in the study.

Alan Auerbach: Slide 27 also compares the grade 3 or 4 AE rates seen in the ALISCA™-Breast1 trial to those that were seen in the previously published phase II of alisertib in HER2-negative ER-positive breast cancer that was published in JAMA Oncology in 2020, referred to as study TBCRC 041. As can be seen in the slide, the rates of grade 3 or higher neutropenia appear to be lower in the ALISCA™-Breast1 trials compared to what was seen in TBCRC 041. To next move to the efficacy seen in the trial. Slide 29 shows the summary of clinical benefits for the patients with at least one post-baseline scan or who ended treatment or died before they got a scan.

By 27 also compares the grade 3 or 4 AE rates, seen in the aliska, breast 1 trial, to those that were seen in the previously published Phase 2 of Al assertive, and her 2 negative, ER, positive breast cancer that was published in gem oncology in 2020, referred to a study TBC 41, as can be seen in the slide, the rates of grade 3 or higher neutropenia appear to be lower in the Alice of breast 1 trials. Compared to what was seen in TBC, RC 41,

To next, move to the efficacy seen in the trial.

Alan Auerbach: As you can see in the slide, the best response was 5% in the 30-milligram arm, 20% in the 40-milligram arm, and 18.4% in the 50-milligram arm. Slide 30 shows the Kaplan-Meier curve for PFS in the trial. As is seen in the slide, the median PFS of the 30-milligram arm is currently 2.04 months. The median PFS of the 40-milligram arm is 5.45 months, and the median PFS of the 50-milligram arm is currently 5.59 months. We will now move to the biomarkers in the trial. Slide 32 presents the KM curve for all the patients in the trial according to c-MYC copy number, also referred to as c-MYC copy number gain.

July 2009 shows the summary of clinical benefits for the patients with at least one post-basic treatment or died before. They got a scan, as you can see in the slide. The best response was 5% in the 30 mg arm, 20% in the 40 mg arm, and 18.4% in the 50 mg arm.

Slides, 30 shows the Kaplan Meier curve for PFS in the trial as a scene and the slide, the median, PFS of the 30 milligram arm is currently 2.04 months. The median, PFS of the 40 migram arm is 5.45 months and the median PFS is a 50 milligram arm is currently 5.59 months.

We will now move to the biomarkers in the trial.

Alan Auerbach: As you can see on the slide, for all of the patients in the trial for which there are tissue results, patients with c-MYC copy number of greater than 2 had a median PFS of 7.29 months versus a median PFS of 2.0 months for the patients with a c-MYC copy number equal to 2. Slide 33 presents the KM curve for all of the patients for which there are tissue results according to percent of tumor cells that are c-MYC positive. As you can see on the slide, for the patients with between 0% and 10% of the cells c-MYC positive, the median PFS was 3.06 months versus a PFS of 5.62 months for the patients with between 11% and 100% of the cells c-MYC positive.

Slide 32, presents the km curve for all the patients in trial according to c MC. Copy number, also, referred to as cmic copy number gain.

As you can see in the slide for all of the patients in the trial for which there are tissue results.

patients with cmic copy number of greater than 2, had a median PFS of 7.29 months, versus a median PFS of 2.0 months for the patients with a cmic copy, number equal to 2

Alan Auerbach: Slide 33 presents the KM curve for all of the patients for which there are tissue results according to percent of tumor cells that are c-MYC positive. As you can see on the slide, for the patients with between 0% and 10% of the cells c-MYC positive, the median PFS was 3.06 months versus a PFS of 5.62 months for the patients with between 11% and 100% of the cells c-MYC positive.

Slide 533 presents this KM curve for all of the patients for which we have our tissue results, according to the percent of tumor cells that are CMIC positive. As you can see on the slide, for the patients with between 0 and 10%...

median PFS was 3.06 months versus the PFS of 5.62 months for the patients with between 11 and 100% of the cells, see a make positive

Alan Auerbach: Slide 34 presents the KM curve for the 50-milligram and 40-milligram doses separately for the patients according to % of tumor cells that are c-MYC positive. As you can see on the slide, for the 40-milligram dose, patients with between 0% and 10% of the cells c-MYC positive had a median PFS of 3.9 months versus a PFS of 5.75 months for the patients with between 11% and 100% of the tumor cells c-MYC positive. For the 50-milligram dose, for patients with between 0% and 10% of the cells c-MYC positive, there was a median PFS of 3.58 months versus a PFS of 9.3 months for the patients with between 11% and 100% of the tumor cells c-MYC positive.

slide 34 presents the km curve for the 50 milligram and 40 milligram doses, separately for the patients, according to percent of tumor cells, that are cmic positive,

As you can see on the slide for the 40, mg dose patients with between 0 and 10% of the cells.

Alan Auerbach: For the 50-milligram dose, for patients with between 0% and 10% of the cells c-MYC positive, there was a median PFS of 3.58 months versus a PFS of 9.3 months for the patients with between 11% and 100% of the tumor cells c-MYC positive.

Alan Auerbach: Similar to the data from ALISCA-Lung1, we believe that these slides are suggesting that in patients with that alisertib has greater efficacy in ALISCA-Breast1 in tumors where a higher percent of the tumor cells are c-MYC positive and hence a greater degree of c-MYC activation. Preclinically, it's been shown that alisertib inhibits c-MYC positive cells, we believe that this increased efficacy is due to the mechanism of action of alisertib and the inhibition of the Aurora kinase pathway. Slide 35 presents the KM curve for all the patients according to ESR1 mutation status.

Cmic positive had a median PFS of 3.9 months, versus a PFS of 5.75 months for the patients with between 11 and 100% of the tumor cells. See MC positive for the 50 milligram dose for patients with between 0 and 10% of the cells cmic positive. There was a median PFS of 3.58 months versus a PFS of 9.3 months for the patients was between 11 and 100% of the consumer sells, see, a MC positive

Alan Auerbach: Preclinically, it's been shown that alisertib inhibits c-MYC positive cells, we believe that this increased efficacy is due to the mechanism of action of alisertib and the inhibition of the Aurora kinase pathway. Slide 35 presents the KM curve for all the patients according to ESR1 mutation status.

Similar to the data from a list. Go along 1. We believe that these slides are suggesting that in patients that in with that alertive has greater efficacy and a list of breast 1 in tumors, where a higher percent of the tumor cells, are cmic positive, and hence a greater degree of semic activation pre-clinical, it's been shown that Alice CV. Inhibits cmic. Positive cells. So we believe that this increased efficacy is due to the mechanism of action of alliser and the ambition of the Aurora kinase pathway.

Alan Auerbach: As is seen on the slide, for patients at all three dose groups who are ESR1 mutated as measured by ctDNA, a median PFS of 5.62 months was seen versus a PFS of 3.58 months for the patients who are ESR1 wild type as measured by ctDNA. For patients at all three dose groups who are ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.71 months for patients who are ESR1 wild type as measured by tissue. It is important for investors to remember that these patients are being treated in the third line setting. These patients have already received treatment with a selective endocrine receptor degrader, or SERD.

535 presents the km curve, for all the patients, according to esr1 mutation status, as is seen on the slide for patients at all. 3, dose groups who are esr1 mutated as measured by ctdna a median. PFS of 5.62 months was seen versus a PFS of 3.58 months for the papers who people who are a esr1 wild type, as measured by CT.

Alan Auerbach: For patients at all three dose groups who are ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen versus a PFS of 3.71 months for patients who are ESR1 wild type as measured by tissue. It is important for investors to remember that these patients are being treated in the third line setting. These patients have already received treatment with a selective endocrine receptor degrader, or SERD.

DNA.

For patients with all 3 dose groups, who are esr1 mutated as measured by tissue? A median. PFS of 7.23 months was seen versus a PFS of 3.71 months for patients, who are esr1 wild type as measured by tissue.

Alan Auerbach: Since enrollment of this trial was done while the newer oral SERDs have either been FDA approved or in later stages of clinical development, many of the patients in the ALISCA-Breast1 trial have been previously treated with the new oral SERDs. More specifically, approximately 58% of the ESR1 mutated patients in the trial were previously treated with oral SERDs, including camizestrant, elacestrant, giredestrant, imlunestrant, or palazestrant. Slide 36 presents the KM curve for the 50-milligram and 40-milligram dose groups separately for patients according to ESR1 mutation status as measured by ctDNA. For patients in the 40-milligram group who are ESR1 mutated as measured by ctDNA, a median PFS of 3.7 months was seen versus a PFS of 5.75 months for the patients who are ESR1 wild type as measured by ctDNA.

It is important for investors to remember that these patients are being treated in the third line setting. So these patients have already received treatment with a selective endocrine receptor, degrader or sir.

Approximately 58% of the ESR1-mutated patients in the trial were previously treated with oral SERDs, including camizestrant, elacestrant, imlunestrant, or giredestrant.

Alan Auerbach: Slide 36 presents the KM curve for the 50-milligram and 40-milligram dose groups separately for patients according to ESR1 mutation status as measured by ctDNA. For patients in the 40-milligram group who are ESR1 mutated as measured by ctDNA, a median PFS of 3.7 months was seen versus a PFS of 5.75 months for the patients who are ESR1 wild type as measured by ctDNA.

Slide, 36 presents the km curve for the 50 milligram and 40 milligram dose groups, separately for patients, according to esr1 mutation status as measured by ctdna.

Alan Auerbach: For patients at the 50-milligram group who are ESR1 mutated as measured by ctDNA, a median PFS of 9.3 months was seen versus a PFS of 2.76 months for the patients who are ESR1 wild type as measured by ctDNA. Slide 37 presents the KM curve for the 50-milligram and 60-milligram dose separately for patients who are ESR1 according to ESR1 mutation status as measured by tissue. For the patients at the 40-milligram group who are ESR1 mutated as measured by tissue, a median PFS of 4.86 months was seen versus a PFS of 4.04 months for the patients who are ESR1 wild type as measured by tissue.

For patients in the 40 milligram group who are esr1 mutated as measured by ctdna a median. PFS of 3.7 months was seen versus a PFS of 5.75 months for the patients, who are esr1 Mi type and measured by ctdna.

For patients at the 50 migram group, who were esr1 mutated as measured by ctdna a median. PFS of 9.3 months was seen versus a PFS of 2.76 months for the patients, who were esr1 wild type as measured by ctdna.

Alan Auerbach: For the patients at the 40-milligram group who are ESR1 mutated as measured by tissue, a median PFS of 4.86 months was seen versus a PFS of 4.04 months for the patients who are ESR1 wild type as measured by tissue.

Alan Auerbach: For the patients of the 50-milligram group who are ESR1 mutated and measured by tissue, a median PFS has not yet been reached versus a PFS of 3.58 months for patients who are ESR1 wild type as measured by tissue. Slide 38 presents the KM curve for all the patients according to PIK3CA mutation status. As is seen on the slide, for patients at all 3 dose groups who are PIK3CA mutated as measured by ctDNA, a median PFS of 2.1 months was seen versus a PFS of 5.45 months for patients who are PIK3CA wild type as measured by ctDNA.

Slide 37, presents the km curve for the 50 milligram and 60 milligram dose separately for patients, who are esr1. According to esr1 mutation status as measured by tissue for the patients. At the 40 milligram group who are esr1 mutated as measured by tissue. A median, PFS of 4.86 months was seen versus a PFS of 4.04 months for the patients, who were esr1 wild type as measured by tissue.

For the patients of the 50 milligram group, who are esr1 mutated and measured by tissue. A median PFS has not yet been reached.

Versus a, PFS of 3.58 months for patients who were esr1 wild type as measured by tissue.

Alan Auerbach: For the patients at all three dose groups who are PIK3CA mutated as measured by tissue, a median PFS of 3.71 months was seen versus a PFS of 4.86 months for patients who are PIK3CA wild type as measured by tissue. Slide 39 shows the KM curve for the 50-milligram and 40-milligram dose separately for patients according to PIK3CA mutation status as measured by ctDNA. For patients at the 40-milligram group who are PIK3CA mutated as measured by ctDNA, a median PFS of 3.71 months was seen versus a PFS of 5.65 for patients who are PIK3CA wild type as measured by ctDNA.

Slide 38 presents the km curve for all the patients according to pick 3ca mutation status, as is seen on the slide for patients at all. 3, dose groups who are pick 3C a mutated as measured by ctdna a median. PFS of 2.1 months was seen versus a PFS of 5.45 months for patients, who were picked 3ca wild type as measured by ctdna.

For the patients at all. 3, dose groups who were picked 3ca mutated as measured by tissue. A median, PFS of 3.71 months was seen versus the PFS of 4.86 months for patients, who were picked 3, Ste a wild type as measured by tissue.

Alan Auerbach: For patients at the 40-milligram group who are PIK3CA mutated as measured by ctDNA, a median PFS of 3.71 months was seen versus a PFS of 5.65 for patients who are PIK3CA wild type as measured by ctDNA.

Slide 39 shows the KM curve for the 50 milligram and 40 milligram doses separately for patients according to PIK3CA mutation status, as measured by ctDNA.

Alan Auerbach: For patients at the 50-milligram group who are PIK3CA mutated as measured by ctDNA, a median PFS of 3.58 months was seen versus a PFS that has not yet been reached for patients who are PIK3CA wild type as measured by ctDNA. Based on the efficacy seen in the patients who were ESR1 mutated and PIK3CA wild type, the company conducted a subset analysis to specifically focus on these two subgroups. Slide 40 presents the KM curve for patients who are PIK3CA wild type according to ESR1 mutation status.

For patients at the 40 milligram group who were picked 3, CCA mutated as measured by ctdna a median. PFS a 3.71 months was seen versus a PFS of 5.65 for patients who were picked 3ca wild type as measured by ctdna.

For patients, at the 50, milligram group who were picked 3ca mutated as measured by ctdna a medium, PFS of 3.58 months was seen versus a PFS that has not yet been reached.

For patients who were picked through, say, a wild type as measured by ctDNA.

Based on the efficacy scene and the patients who were ESR1-mutated and PIK3CA wild type, the company conducted a subset analysis to specifically focus on these two subgroups.

Alan Auerbach: Slide 40 presents the KM curve for patients who are PIK3CA wild type according to ESR1 mutation status. As is seen on the slide, for patients at all 3 dose groups who are PIK3CA wild type and who had an ESR1 mutation as measured by ctDNA, a median PFS has not yet been reached versus a PFS of 3.48 months for patients who were PIK3CA wild type and ESR1 wild type as measured by ctDNA.

Slide, 40 presents the km curve.

Alan Auerbach: As is seen on the slide, for patients at all 3 dose groups who are PIK3CA wild type and who had an ESR1 mutation as measured by ctDNA, a median PFS has not yet been reached versus a PFS of 3.48 months for patients who were PIK3CA wild type and ESR1 wild type as measured by ctDNA. For patients at all 3 dose groups who were PIK3CA wild type and who had an ESR1 mutation as measured by tissue, a median PFS has not been reached versus a PFS of 2.79 months for patients who were PIK3CA wild type and ESR1 wild type as measured by tissue. Slide 41 presents the KM curve according to 50-milligram and 40-milligram doses separately for the patients who were PIK3CA wild type according to ESR1 mutation status as measured by ctDNA.

For patients who were picked 3ca wild type, according to the esr1 mutation status.

As is seen on the slide for patients at all. 3 dose groups who were picked 3ca wild type and who had an esr1 mutation as measured by ctdna.

a median PFS has not yet been reached versus a PFS of 3.48 months for patients who were picked 3, say a while type

And esr1 Mild type that measured by ctdna.

Alan Auerbach: For patients at all 3 dose groups who were PIK3CA wild type and who had an ESR1 mutation as measured by tissue, a median PFS has not been reached versus a PFS of 2.79 months for patients who were PIK3CA wild type and ESR1 wild type as measured by tissue. Slide 41 presents the KM curve according to 50-milligram and 40-milligram doses separately for the patients who were PIK3CA wild type according to ESR1 mutation status as measured by ctDNA.

For patients that all 3 dose groups who were pick 3ca wild type.

And who had an esr1 mutation as measured by tissue a median PFS has not been reached versus a PFS of 2.79 months for patients who are picked 3 c, a wild type and esr1 wild type as measured by tissue.

Alan Auerbach: For PIK3CA wild type patients at the 40 mg group who are ESR1 mutated as measured by ctDNA, a median PFS of 4.86 months was seen versus a PFS of 5.75 months for the patients who were ESR1 wild type as measured by ctDNA. For PIK3CA wild type patients at the 50 mg group who were ESR1 mutated, the median PFS has not been reached versus a median PFS of 2.14 months in the patients who were ESR1 wild type as measured by ctDNA. We are very pleased to see that at the 50 mg dose group for the patients who were PIK3CA wild type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.

Slide 41, presents the km curve. According to 50 milligram and 40 milligram. Joseph separately for the patients who were picked 3, Ste a wild type, according to esr1 mutation status as measured by ctdna.

For pick 3ca, wild type patients at the 40 milligram group who are esr1 mutated as measured by ctdna a median. PFS of 4.86 months was seen versus a PFS of 5.7 5 months for the patients who were esr1 wild type as measured by ctdna.

Alan Auerbach: We are very pleased to see that at the 50 mg dose group for the patients who were PIK3CA wild type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed.

Wild type as measured by ctdna.

We are very pleased to see that at the 50 mg dose group for the patients who were picked 3ca wild type and esr1 mutant. No patient has yet progressed. Although we caution these numbers here are small and further, patient, follow-up as needed.

Alan Auerbach: Slide 42 presents the KM curve for the 50 milligram and 40 milligram dose separately for patients who are PIK3CA wild type according to ESR1 mutation status as measured by tissue. For PIK3CA wild type patients at the 40 milligram group who are ESR1 mutated as measured by tissue, a median PFS of 7.23 months was seen, versus a PFS of 3.98 months for the patients who were ESR1 wild type as measured by tissue. For PIK3CA wild type patients at 50 milligrams who are ESR1 mutated, the median PFS has not been reached versus a median PFS of 2.14 months in the patients who are ESR1 wild type as measured by tissue.

Slide 42 presents the KM curve for the 50 milligram and 40 milligram dose separately for patients who are PIK3CA wild type, according to ESR1 mutation status as measured by tissue.

For Pick 3 c. A wild type patients at the 40 milligram group who are esr1 mutated as measured by tissue. A medium. PFS is 7.23. Months was seen versus a PFS of 3.98 months for the patients who were esr1 wild type as measured by tissue.

For Pick 3, say a wild type patients at 50 milligrams who were esr1 mutated.

Alan Auerbach: We are very pleased to see that the 50 milligram dose group for the patients who are PIK3CA wild type and ESR1 mutant, no patient has yet progressed, although we caution these numbers here are small and further patient follow-up is needed. As was shown in the earlier slides, c-MYC appeared to play a role in the activity of alisertib in HER2 negative, ER positive breast cancer. More specifically, the analysis on slides 34, 33 and 34 showed that alisertib had better activity in patients with a higher percent of their cells being c-MYC positive. This analysis also showed that patients with between 11% to 100% of their cells being c-MYC positive showed the best activity with alisertib.

The B and PFS has not been reached versus a median. PFS of 2.14 months, in the patients who were esr1, wild type as measured by tissue again, we are very pleased to see that the 50 mg dose group for the patients who are Pick 3 say wild type and esr1 mutant. No patient has yet progressed. Although we caution these numbers here are small and further patient, follow-up as needed.

Alan Auerbach: More specifically, the analysis on slides 34, 33 and 34 showed that alisertib had better activity in patients with a higher percent of their cells being c-MYC positive. This analysis also showed that patients with between 11% to 100% of their cells being c-MYC positive showed the best activity with alisertib.

As was shown in the earlier. Slides cmic appeared, to play a role in the activity of Alice certed in her 2 negative, ER, positive breast cancer and more specifically the analysis on slides, 34 33. And 34 showed that Alice had better activity and patients with a higher percent of their cells being semic positive.

Alan Auerbach: We therefore conducted an analysis to see whether or not c-MYC had any correlation with the activity of alisertib that we are seeing in the PIK3CA wild type patients, the ESR1 mutated patients, or the patients who are both PIK3CA wild type and ESR1 mutated. On slide 43, we present the data that shows the % of c-MYC positive cells for PIK3CA wild type, ESR1 mutated, and patients who are both PIK3CA wild type and ESR1 mutated. The left-hand side of the slide presents the patients whose mutation status was determined by tissue. The right-hand side of the slide shows the patients whose mutation status was by ctDNA. As you can see on the slide, patients who are PIK3CA wild type, patients who are ESR1 mutated, and patients who are both PIK3CA wild type and ESR1 mutated appear to show an increase in the median % of c-MYC positive cells.

This analysis also showed that patients with between 11 to 100% of their cells. Being same like positive showed the best activity with all assertive.

Alan Auerbach: On slide 43, we present the data that shows the % of c-MYC positive cells for PIK3CA wild type, ESR1 mutated, and patients who are both PIK3CA wild type and ESR1 mutated. The left-hand side of the slide presents the patients whose mutation status was determined by tissue. The right-hand side of the slide shows the patients whose mutation status was by ctDNA. As you can see on the slide, patients who are PIK3CA wild type, patients who are ESR1 mutated, and patients who are both PIK3CA wild type and ESR1 mutated appear to show an increase in the median % of c-MYC positive cells.

We therefore conducted an analysis to see whether or not cmic had any correlation with the activity of ALC that we are seeing in the P. 3ca wild type patients. The esr1 mutated patients, or the patients, who are both Pick 3, say a wild type and esr1 mutated on, slide 43. We present the data that shows the percent of cmic, positive cells for Pick 3, c, a wild type esr1 mutated and patients, who were both picked? 3 to say wild type, and esr1 mutated the left hand side of the slide presents, the patients, whose mutation status was determined by tissue. The right hand side of the slide shows, the patients whose mutation status was by CT, D, nag.

As you can see on the slide.

Alan Auerbach: This is seen in both the patients where the mutation status is determined by ctDNA and in tissue. It is also seen in this analysis that a high percent of the patients who are PIK3CA wild type, who are ESR1 mutant, and who are both PIK3CA wild type and ESR1 mutant have between 11% to 100% of their cells being c-MYC positive, which is again where the best activity at alisertib has been shown to occur.

Patients who are pick 3ca, wild type patients, who are esr1 mutated and patients? Who are both Pick 3? Say a wild type, and esr1 mutated appear to show an increase in the median percent of cmic positive cells. This is seen in both the patients where the mutation status is determined by ctdna and in tissue.

Alan Auerbach: We believe this analysis is suggesting that better activity being seen with alisertib in the patients who are PIK3CA wild type, ESR1 mutated, or both PIK3CA wild type and ESR1 mutated may be due to this increased c-MYC activity, as it appears to be showing that c-MYC is playing a role in driving the tumor in these subgroups of patients, which is suggestive of tumors where the Aurora kinase A is activated and hence where alisertib's mechanism of action may be playing a role. When Puma licensed alisertib, it had stated that the goal was to enroll ALISCA-Breast1 in order to perform a biomarker analysis to better understand which biomarker subgroups had the best activity and then amend the trial to focus on a more biomarker-focused population.

It is ALS seen in this analysis that a high percent of the patients who are Pick 3 say a wild type who are esr1 mutants and who are both pixelated, say a wild type and esr1 mutant have between 11 to 100% of their cells. Being semic positive, which is again, where the best activity is all assertive has been shown to occur.

We believe this analysis is suggesting the bet that better activity, being seen with alerted and the patients who are picked through to see a wild type esr1 mutated or both Pick 3 is a wild type, and esr1 mutated may be due to this increase cmic activity and it as it appears to be showing that cmic is playing a role and driving the tumor in these subgroups of patients, which is, which is suggestive of tumors, where the outro with the Aurora. Kindness a is activated and hence, where Alice mechanism of action may be playing a role.

Alan Auerbach: When Puma licensed alisertib, it had stated that the goal was to enroll ALISCA-Breast1 in order to perform a biomarker analysis to better understand which biomarker subgroups had the best activity and then amend the trial to focus on a more biomarker-focused population.

Alan Auerbach: Based on the interim data from ALISCA-Breast1, the company is going to be expanding the enrollment in the trial to obtain more data on the biomarker-focused cohorts with a focus in the patients who are PIK3CA wild type, ESR1 mutant, or both. The company anticipates this will occur in H2 2026. The company also plans to present updated data on the ALISCA-Breast1 trial in H2 2026. Similar to the data from ALISCA-Lung1, we believe that the data generated thus far in ALISCA-Breast1 is showing that alisertib in combination with endocrine therapy appears to be active in the third-line setting and more specifically in patients who are PIK3CA wild type, ESR1 mutant, or both PIK3CA wild type and ESR1 mutant.

When Puma licensed all assertive, it had stated that the goal was to enroll Alisa breast 1 in order to perform a biomarker analysis, to better understand, which biomarker subgroups had the best activity and then amend the trial to focus on a more biomarker focused population.

Based on the interim data from Alisa breast 1, the company is going to be expanding the enrollment in the trial to obtain more data on the biomarker. Focused cohorts, with a focus in the patients, who are Pick 3 to say wild type esr1 mutant or both?

The company anticipates this role occur in the second half of 2026.

The company also plans to present updated data.

Alan Auerbach: Similar to the data from ALISCA-Lung1, we believe that the data generated thus far in ALISCA-Breast1 is showing that alisertib in combination with endocrine therapy appears to be active in the third-line setting and more specifically in patients who are PIK3CA wild type, ESR1 mutant, or both PIK3CA wild type and ESR1 mutant.

On the Alisa breast 1 trial and the second half of 2026.

Alan Auerbach: Similar to ALISCA™-Lung1, the activity of alisertib in the trial appears to be driven by c-MYC. To our knowledge, we are not aware of any drugs that have shown this level of activity in these subgroups of patients in the third line, which we believe differentiates the drug from others in development. We believe that this activity is attributable to biomarkers that are indicative of aurora kinase pathway activation, which we believe is in line with the mechanism of action of alisertib. As we've mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial-stage and development-stage drugs to potentially in-license and acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, or commercial infrastructure. The company will keep investors updated on this as it progresses.

Similar to the data from alisco. Lung 1. We believe that the data generated thus far and Alisa breast 1 is showing that Alice sort of. In combination with endocrine therapy appears to be active in the third line setting and more specifically in patients who are Pick 3. Say a wild type esr1 mutant or both Pick 3 is a wild type and esr1 mutant

To our knowledge, we are not aware of any drugs that have shown this level of activity in these subgroups of patients in the third line.

Which we believe differentiates the drug from others in development.

We believe that this activity is attributable to biomarkers, that are indicative of Aurora kinase pathway activation, which we believe is in line with the mechanism of action of allosaurus.

Alan Auerbach: As we've mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial-stage and development-stage drugs to potentially in-license and acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, or commercial infrastructure. The company will keep investors updated on this as it progresses.

As we've mentioned on prior earnings calls and response to investor questions, Puma continues to evaluate several commercial stage and development stage. Shrugs to potentially in licensed and require that would allow the company to diversify itself and leverage Puma's existing R&D regulatory or commercial infrastructure.

Alan Auerbach: I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.

The company will keep investors updated on this as it progresses.

Heather Blaber: Thanks, Alan Auerbach. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with healthcare professionals through both personal and non-personal promotion. Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression.

I will now turn the call over to Heather blabber for an update on our marketing initiatives. Roger storms will follow with a review of our commercial performance during the quarter.

The marketing team is focused on continued awareness of both clinical data for neuralink.

As well as reinforcing the continued unmet need and her 2 positive for early stage breast cancer, after adjectives therapy.

Heather Blaber: Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression.

And validate the most effective ways to communicate our data with Healthcare professionals through both personal and non-personal promotion.

Heather Blaber: Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post-adjuvant treatment, but we continue to adopt new prescribers year over year who recognize the unmet need in HER2 positive early-stage breast cancer and how NERLYNX can help their patients. In summary, we are excited and committed about the potential to engage with more oncologists and support their patients diagnosed with HER2 positive breast cancer in both the early and metastatic setting. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the first quarter.

Our strategy is focused on increasing awareness of our dual indication in HER2-positive breast cancer. We believe Nerlynx plays an important role in the early stage by reducing the risk of recurrence, and in the metastatic setting by helping protect against progression.

Not only do Physicians, who have experience with neurolinks, continue to identify appropriate patients, that could benefit from additional therapy, post, adjuvant treatment. But we continue to adopt new prescribers year-over-year who recognize the unmet need in her 2 positive early stage breast cancer and how neural links can help their patients.

In summary, we are excited and committed about the potential to engage with more oncologists and support their patients. Diagnosed with her2 positive, breast cancer in, both the early and metastatic setting.

Roger Storms: Thank you, Heather, and thanks to everyone for joining our Q1 earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency with a strong emphasis on driving engagement when treatment decisions are being made. Q1 2026 call activity increased 44% year over year and 14% quarter over quarter. The year over year and quarter over quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. The commercial team continues to prioritize increasing use of NERLYNX with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts, as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.

I will now turn the call over to Roger storms to provide an overview on the commercial performance, for the first quarter.

Thank you, Heather. And thanks to everyone for joining our first quarter earnings call.

Before I move into the commercial review, just a reminder that I'll be making forward-looking statements.

The sales team remains focused on expanding overall HCP reach and frequency, with a strong emphasis on driving engagement when treatment decisions are being made.

Roger Storms: The year over year and quarter over quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. The commercial team continues to prioritize increasing use of NERLYNX with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts, as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy.

Roger Storms: Let me now transition to some of the commercial slides, where I'll provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. Regarding the overall distribution of our business, in Q1 2026, about 58% of our business was purchased through the SP channel and the remaining 42% was purchased through the SD channel. We continue to see stronger growth in the SD channel, driven mainly by increased sales in the group purchasing organizations or GPO segment.

Q1 2026, call activity, increased 44%, year-over-year and 14% quarter over quarter, the year-over-year and quarter-over-quarter increases are a direct result of continued. Emphasis put on executional excellence and increased field accountability, the commercial team continues to prioritize increasing use of narrow links with the main focus on patients, at higher risk of recurrence. They are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts as well as utilizing patient resources to support persistence and compliance during their length therapy.

Let me now transition to some of the commercial slides, where I'll provide some additional specifics around performance.

Slide 3 is an illustration of our distribution model, which is broken out into the Specialty Pharmacy Channel, and the specialty distributor, or an office dispensing channel.

Regarding the overall distribution of our business in Q1 2026, about 58% of our business was purchased through the SB Channel, and the remaining 42% was purchased through the SD Channel.

Roger Storms: Turning to slide 4, NERLYNX net product revenue in Q1 2026 was $42 million, which represents a decrease of $17.9 million from the $59.9 million we reported in Q4 2025, and a decrease of $1.1 million from the $43.1 million we reported in Q1 2025. As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and pro-product supply revenues of NERLYNX to Puma's ex-US partners. Please note that in Q1 2025, we reported product supply revenue to our international partners of approximately $400,000 versus the $150,000 in Q1 2026. US net sales of NERLYNX in Q1 2026 were $41.8 million versus the $42.7 million in Q1 2025.

We continue to see stronger growth in the SD, Channel driven, mainly by increased sales in in the group purchasing organizations or GPO segment.

Turning the slide 4.

Roger Storms: Please note that in Q1 2025, we reported product supply revenue to our international partners of approximately $400,000 versus the $150,000 in Q1 2026. US net sales of NERLYNX in Q1 2026 were $41.8 million versus the $42.7 million in Q1 2025.

Near Link's net product, Revenue in q1, 26 was 42 million which represents a decrease of 17.9 million from the 59.9 million. We reported in Q4 2025 and a decrease of 1.1 million from the 43.1 million. We reported in q1 of 2025 as a, reminder to investors Puma's reported near link sales include both us. Net sales of narrow links and products Supply revenues of narrow links to Puma's exas partners.

Roger Storms: I'll provide some more details around inventory changes and Maximo will provide some additional specifics around gross to net expenses during his update. In Q1 2026, we estimate that inventory decreased by about $7.9 million. As a comparator, we estimate that inventory increased by about $5.7 million in Q4 2025. Slide five shows Q1 2026 ex-factory bottle sales and also provides both a year-over-year and quarter-over-quarter comparison. In Q1 2026, NERLYNX ex-factory bottle sales were 2,328, which represents an approximate 29% decrease quarter-over-quarter, while remaining essentially flat at 0.4% year-over-year. Let me specifically call out the inventory changes from a bottle perspective. In Q1 2026, we estimate that inventory decreased by about 439 bottles.

Sales of NERLYNX in Q1 2026 were $41.8 million versus $42.7 million in Q1 of 2025.

I'll provide some more details around inventory changes and maximum will provide some additional specifics around gross to net expenses during his update.

Roger Storms: Slide five shows Q1 2026 ex-factory bottle sales and also provides both a year-over-year and quarter-over-quarter comparison. In Q1 2026, NERLYNX ex-factory bottle sales were 2,328, which represents an approximate 29% decrease quarter-over-quarter, while remaining essentially flat at 0.4% year-over-year. Let me specifically call out the inventory changes from a bottle perspective. In Q1 2026, we estimate that inventory decreased by about 439 bottles. As a comparator, we estimate that inventory increased by 343 bottles in Q4 2025 and decreased by 251 bottles in Q1 2025.

In q1 2026, we estimate the inventory. Decreased by about 7.9 million. As a comparator, we estimate that inventory increase by about 5.7 million in Q4 of 2025.

Slide 5 shows q1 2026, xfactory bottle sales and also provides both a year-over-year and quarter-over-quarter comparison.

In q1 2026 nerlynx, xfactory bottle sales were 2,328, which represents an approximate 29% decrease quarter of a quarter while remaining essentially flat at 0.4.

Year-over-year.

Inventory, changes from a bottle of perspective in q1 2026.

Roger Storms: As a comparator, we estimate that inventory increased by 343 bottles in Q4 2025 and decreased by 251 bottles in Q1 2025. Let me take a moment to provide some additional metrics regarding our Q1 performance. In Q1 2026, we saw enrollments increase by about 10% quarter-over-quarter and about 1% year-over-year. Commercial new patient starts or NRXs were even stronger, increasing by about 25% quarter-over-quarter and about 11% year-over-year. Turning to total prescriptions or TRXs, we saw TRXs decline about 4% quarter-over-quarter and about 1% year-over-year. Finally, let me share some specifics around commercial demand overall. In Q1 2026, we saw demand decrease by about 6% quarter-over-quarter, increase by about 7% year-over-year.

Roger Storms: Let me take a moment to provide some additional metrics regarding our Q1 performance. In Q1 2026, we saw enrollments increase by about 10% quarter-over-quarter and about 1% year-over-year. Commercial new patient starts or NRXs were even stronger, increasing by about 25% quarter-over-quarter and about 11% year-over-year. Turning to total prescriptions or TRXs, we saw TRXs decline about 4% quarter-over-quarter and about 1% year-over-year. Finally, let me share some specifics around commercial demand overall. In Q1 2026, we saw demand decrease by about 6% quarter-over-quarter, increase by about 7% year-over-year.

We estimate the inventory. Decreased by about 439 bottles. As a comparator, we estimate that inventory increased by 343 bottles, in Q4 of 2025 and decreased by 251 bottles in q1 of 2025.

Let me take a moment to provide some additional metrics regarding our first quarter performance in Q1 2026. We saw enrollments increase by about 10% quarter-over-quarter and about 1% year-over-year. Commercial new patient starts, or NRx, is even stronger, increasing by about 25% quarter-over-quarter and about 11% year-over-year.

In the total prescriptions, or TRX, we saw TRX decline about 4% quarter over quarter and about 1% year over year.

Roger Storms: As mentioned, these dynamics are strongly influenced by SD patterns. In Q1 2026, we saw SD demand decrease by about 9% quarter-over-quarter due to Q4 buy-ins while continuing to show strong growth year-over-year at about 28%. Slide six highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q1 2026, approximately 78% of patients started NERLYNX at a reduced dose. This is higher compared to the 75% we reported in Q4 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. We believe dose escalation coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide seven highlights the strategic collaborations we formed across the globe.

We let me share some specifics around, commercial demand. Overall in q1 2026. We saw a demand decreased by about 6% quarter over quarter. But increase by about 7% year-over-year as mentioned these Dynamics are strongly influenced by SD patterns,

And q1 2026. We saw SD demand decrease by about 9% quarter-over-quarter due to Q4, buy-ins while continuing to show strong growth year-over-year at about 28%.

Roger Storms: This is higher compared to the 75% we reported in Q4 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. We believe dose escalation coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide seven highlights the strategic collaborations we formed across the globe.

Slide 6 highlights the quarterly adoption of dose escalation since the launch of nerlynx in q1 2026. Approximately 78% of patients started, nerlynx at a reduced dose. This is higher compared to the 75%. We reported in Q4 of 2025.

Continued messaging and dose and dose continued messaging and Adoption of dose escalation remains an important commercial Priority. We Believe dose escalation coupled with patient education resources will give patients better support throughout their nerlynx therapy.

Roger Storms: Most recently, in Q1 2026, NERLYNX was launched in Thailand, also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward. I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating. While meaningful progress has been made, we know there's still important work ahead and even more we can accomplish together. I'll now turn the call over to Maximo for review of our financial results.

7 highlights, the Strategic collaborations, we formed across the globe. Most recently, in q1 2026. Near links was launched in Thailand. Also, in the extended Advent setting, we really appreciate the excellent work being done by our partners around the world, and look forward to supporting their continued success. Moving forward.

I'll close by sharing my sincere, appreciation for the entire Puma team and their steadfast commitment to supporting patients and families, affected by breast cancer. This disease is truly devastating. And while meaningful progress has been made, we know there's still important work ahead and even more we can accomplish us together.

Although, I'll turn the call over to Maximo for review of our financial results.

Maximo Nougues: Thanks, Roger. I will begin with a brief summary of our financial results for Q1 2026. Please note that I will make comparisons to Q4 2025, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our Q1 2026 10-Q, which will be filed today and includes our consolidated financial statements. For Q1 2026, we reported a net loss based on GAAP of $3.8 million or $0.07 per share. This compares to net income in Q4 2025 of $13.4 million or $0.27 per basic share and $0.26 per diluted share. The Q4 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million.

Thanks Roger. I will begin with a brief summary of our financial results for the first quarter of 2026,

Please note that I will make comparisons to Q4 2025, which we believe is a better indication of our progress, as a commercial company than year-over-year comparisons.

Maximo Nougues: For Q1 2026, we reported a net loss based on GAAP of $3.8 million or $0.07 per share. This compares to net income in Q4 2025 of $13.4 million or $0.27 per basic share and $0.26 per diluted share. The Q4 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million.

For more information, I recommend that you refer to our first quarter 20126. Thank you, which will be filed today and includes our Consolidated financial statements.

For the first quarter of 2026, we reported a net loss based on gap of 3.8 million or 7 cents per share.

This compares to net income in Q4 2025 or 13.4 million or 27 cents per basic share and 26, cents per diluted share.

The fourth quarter of 2025 included, a net change in valuation, allowance that on favorably impacted net income by 3.2 million.

Maximo Nougues: On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $1.9 million for $0.04 per share for Q1 2026. Gross revenue from NERLYNX sales was $57.5 million in Q1 2026 and $82.9 million in Q4 2025. As Alan mentioned, net product revenue from NERLYNX sales was $42 million, an increase from the $59.9 million reported in Q4 2025 and the $43.1 million reported in Q1 2025. A reminder to investors, Puma reported NERLYNX sales includes both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma ex-US partners. Please note that in Q1 2026, we reported product supply revenue to our international partners of about $0.1 million.

A net loss of 1.9 million for 4 cents per share for the first quarter of 2026.

Ross revenue from nailing sales, was 57.5 million in q1 2026.

And 82.9 million in Q4 2025.

Alan mentioned it net, Proto revenue from nailing sales was 42 million.

An increase from the 59.94% reported in q1, 2025.

Maximo Nougues: A reminder to investors, Puma reported NERLYNX sales includes both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma ex-US partners. Please note that in Q1 2026, we reported product supply revenue to our international partners of about $0.1 million.

A reminder to investors. Put my report in nailing sales includes both us, net sales of nerl, links and product Supply, revenues of nerling to Puma X us partners.

Maximo Nougues: Therefore, US net sales of NERLYNX in Q1 2026 were $41.9 million versus $55.2 million in Q4 2025. The decrease in Q1 2026 versus Q4 2025 was driven by lower demand inventory reduction in Q1 of about $7.9 million versus inventory increase of $5.7 million in Q4 2025. Royalty revenue totaled $2.8 million in Q1 2026 compared to $15.6 million in Q4 2025. The decline in royalty revenue reflects a large Q4 2025 shipment to our partner in China. Our gross to net adjustment in Q1 2026 was about 27% and 27.8% in Q4 2025. The lower gross to net adjustment was driven mostly by lower government chargebacks.

Please note that in q1 2026, we reported product Supply Revenue to our International partners of about 0.1 million.

Therefore us, net sales of nerd, links in q1 2026 were 41.9 million versus 5, 5, 5. 2 2 5.

The decrease in q1 2026 versus Q4 2025 was driven by lower demand inventory, reduction, in q1 of about 7.9 million versus inventory. Increase of 5.7 million in Q4 2025,

Royalty Revenue, total 2.8 million in the first quarter of 2026 compared to 15.6 million in Q4 2025.

The decline in royalty revenue reflects a large Q4 2025 shipment to our partner in China.

Our gross to net adjustment in Q1 2026 was about 27%, and 27.8% in Q4 2025.

A lower gross. Net adjustment was driven mostly by lower government chargebacks.

Maximo Nougues: Cost of sales for Q1 2026 was $10.4 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q4 2025 was $23.2 million. Going forward, we will continue to recognize amortization of milestones to the license of about $2.4 million per quarter as cost of sales. For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $202 to 206 million, higher than our prior guidance of $194 to 198 million.

Total sales for Q1 2026 were $10.4 million and include $2.4 million for the amortization of intangible assets related to our NERLYNX license.

Go to sales for Q4 2025 was 23.2 million.

Going forward, we will continue to recognize a motivation of Milestones to their license or of about 2.4 million per quarter as cost of sales.

For fiscal year, 2026 Puma anticipates, that net nerling product and revenue will be in the range of 202 to 206 million.

Maximo Nougues: We also anticipate that our gross to net adjustment for the full year 2026 will be between 26.5% and 27.5%, significantly higher than 2025 as we expect higher government chargebacks and Medicare and Medicaid share to maintain the levels we saw in the last two quarters of 2025. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 to 23 million. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $16 to 19 million, also higher than our prior guidance of $10 to 13 million. Current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate.

Higher than our prior guidance of 194 to 198 million.

We also anticipate that our gross-to-net adjustment for the full year 2026 would be between 26.5% and 27.5%.

Maximo Nougues: In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 to 23 million. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $16 to 19 million, also higher than our prior guidance of $10 to 13 million. Current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate.

Significantly higher than 2025, as we expect higher government chargebacks and Medicare and Medicare share to maintain the labels. We saw in the last 2 quarters of 2025

in addition.

fiscal year 2025, we anticipate receiving royalties from our partners around the world, in the range of 20 to 23 million

We don't expect any licensed revenue in 2025.

We also expect that net income for the full year, will be in the range of 16 to 19 million.

Also higher than our prior guidance of 10 to 13 million.

Maximo Nougues: The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis, as of not yet determined whether any adjustments will be required. If so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses. This time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product costs or results of operations. However, shifts in the trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid-to-high single-digit percentage of our total cost of goods sold.

Current guidelines does not include any potential release of adding additional tax asset. Valuation allowance in our net income estimate.

The company is reviewing, its the fair tax assets.

As part of its ongoing tax valuation analysis as a, not yet determined, whether any adjustments will be required. If so the potential timing or size of such an adjustment,

We will continue to go to keep investors updated on this asset progresses.

This time, we do not believe that tariffs impose or propose to be imposed.

By the United States.

Maximo Nougues: However, shifts in the trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid-to-high single-digit percentage of our total cost of goods sold.

Particularly, with other countries will have a material impact on our protocols or costs or results of operations.

However, shift in the trade policies in the United States and other countries have been rapidly evolving.

And are difficult to predict.

As a point of reference, our manufacturing product costs accounts for a mid to high single-digit percentage of our total cost of goods sold.

Maximo Nougues: We anticipate that for Q2 2026, NERLYNX product revenue will be in the range of $50 to $52 million. We expect Q2 royalties revenues will be in the range of $2 to $3 million and no license revenue. We further estimate that the gross-to-net adjustment in Q2 2026 will be approximately 27% to 28%. Puma anticipates a Q2 net income between $2 million and $4 million. SG&A expenses were $18.4 million in Q1 2026, unchanged from Q4 2025. SG&A expenses include non-cash charges for stock-based compensation of $1.1 million for Q1 2026 and $1 million in Q4 2025. Research and development expenses were $19.8 million in Q1 2026 and $16.8 million in Q4 2025.

We anticipate that for Q2 2026. Now, links product Revenue will be in the range of 50 to 52 million.

We expect Q2 royalties revenues.

No license Revenue.

We further estimate that the gross to net adjustment in Q2 2026 will be approximately 27 to 28%.

To anticipate a Q2 net income between 2 million and 4 million.

Maximo Nougues: SG&A expenses were $18.4 million in Q1 2026, unchanged from Q4 2025. SG&A expenses include non-cash charges for stock-based compensation of $1.1 million for Q1 2026 and $1 million in Q4 2025. Research and development expenses were $19.8 million in Q1 2026 and $16.8 million in Q4 2025.

Sgna expenses were 18.4 million and the first quarter of 2026 and change from the fourth quarter of 2025.

Sgna expenses. Include non-cash charges for stock based. Compensation, 1.1 million for q1, 2026 and 1 million in Q4 2025.

Maximo Nougues: R&D expenses included non-cash charges for stock-based compensation of $0.8 million in Q1 2026 and $0.7 million in Q4 2025. On the expense side, Puma anticipates higher total operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 1% to 2% and R&D expenses to increase by 34% to 37% year over year. The higher increase in R&D expense is driven by the progress of our clinical trials. In Q1 2026, Puma reported cash earned of approximately $4 million. This compares to cash earned of approximately $3.1 million in Q4. Please note that during Q1 2026, we made our eighth quarterly principal loan payment of $11.1 million related to our obligation with Athyrium.

Research on the development. Expenses were 8 19.8 million in the first quarter of 2026 and 16.8 million in Q4 2025.

Are in the expenses. Included non-cash charges for stock based compensation of 0.8 million in q1 2026 and 0.7 million in Q4 2025.

On the expense side 2 mantis higher total of operating expenses in 2026 compared to 2025.

More specifically, we anticipate sgna expenses to increase by 1 to 2%.

And are in the expenses to increase by 34 to 37% year-over-year.

Maximo Nougues: The higher increase in R&D expense is driven by the progress of our clinical trials. In Q1 2026, Puma reported cash earned of approximately $4 million. This compares to cash earned of approximately $3.1 million in Q4. Please note that during Q1 2026, we made our eighth quarterly principal loan payment of $11.1 million related to our obligation with Athyrium.

As.

the first quarter of 2026 Puma reported cash earn of approximately 4 million,

This compares to cash earned of approximately $3.1 million in Q4.

Maximo Nougues: Furthermore, after quarter-end, we made our final payment to Athyrium, and as a result, Puma is now debt-free. On 31 March 2026, we had approximately $101.5 million in cash equivalents, and marketable securities versus about $97.5 million at year-end 2025. Our accounts receivable balance was $26.3 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstanding are about 46 days. We estimate that as of 31 March 2026, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX and the development of alisertib and controlling our expenses.

Please note that during q1 2026, we made our 8th quarterly, principal loan payment of 11.1 million related to Our obligation with ethereum.

Furthermore, after quarter end, we made our final payment to ethereum and as a result Puma is now debt free.

On March 31st 2026. We had approximately 100.1 101.5 million in cash. Cash equivalents and marketable securities.

Versus about 97.5 million at the year end.

2025.

Our accounts receivable balance was 26.3 Million our accounts receivables, terms range between 10 and 68 days.

Maximo Nougues: We estimate that as of 31 March 2026, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX and the development of alisertib and controlling our expenses.

For our Day, sales outstanding are about 46 days.

We estimate that as of March, 31st 2026.

Our distribution Network maintain approximately 3 weeks of inventory.

Overall, we continue to deploy our financial resources to focus on the commercialization.

Assertive and controlling our expenses.

Alan Auerbach: Thanks, Maximo. On past earnings calls, we have stressed that Puma senior management, in cooperation with the board of directors, continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution in a positive way as according to our current projections, 2026 will mark the second year-over-year demand increase for NERLYNX in the United States and the first time in the history of the launch of NERLYNX in the US that we have seen two positive consecutive year-over-year increases in demand.

Thanks Maximo.

Alan Auerbach: We are pleased to report this demand-driven growth in NERLYNX sales in Q1 2026, which has been driven by better than expected enrollments and better than expected new patient starts, as well as strong increases in sales to our specialty distributors. In addition, we believe that the positive net income that the company is guiding to for full year 2026 has resulted from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed in order to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors.

On past earnings calls, we have stressed that Puma Senior Management and cooperation with the board of directors, continues to remain focused on nearly sales Trends and recognizes its fiscal responsibility to shareholders, to continue to maintain positive net income. We believe that this Focus has contributed to our commercial execution and a positive way. And according to our current projections 2026 will Mark the second year-over-year demand increase for near links in the United States and the first time in the history of the launch of the are links. In the US that we have seen 2 positive consecutive year-over-year increases in demand.

We are pleased to report this demand-driven growth in nearing sales, in the first quarter of 2026, which has been driven by better than expected, enrollments and better than expected. New patients starts as well as strong increases in sales to our specialty distributors

Alan Auerbach: The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed in order to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors.

In addition, we believe that the positive net income that the company is guiding to for full year, 2026 has resulted from the continued Financial discipline across the company. Over the last few years, the company remains committed to continuing to achieve this positive, net income, and will continue to reduce expenses if needed in order to achieve this, we look forward to updating investors on this in the future.

Alan Auerbach: We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

There continues to remain a significant unmet need for patients battling breast cancer, lung, cancer and other solid tumors.

We had pumar committed and passionate about finding more effective ways and helping these patients during their journey. And we will continue to strive to achieve that goal.

This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.

Operator: Thank you. We will now begin the question and answer session. If you wish to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the questioning queue. If you wish to withdraw your request, please press star two. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for any questions. The first question comes from the line of Salvatore Caruso with TD Cowen. Please proceed with your question.

I will now begin the question.

If you wish to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. If you wish to withdraw your request, please press star 2.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

And the first question comes from the line of Salvatore Caruso with TD Cowen, please proceed with your question.

Salvatore Caruso: Hi. Congrats on the data. I'm looking forward to more mature data sets. This is on behalf of Marc Frahm at TD Cowen. Two quick questions. The first one, given the emerging signal in c-MET positive patients in both lung and breast that you presented today, how are you thinking about incorporating c-MET biology going forward into future trial designs? Do you see like, for example, in your registrational strategy that it evolving into some sort of biomarker enrich program with maybe a more narrow, you know, patient selection? Then I'll ask my second one after.

Hi, uh, congrats on the data, I'm looking forward to more mature data sets. Um, this is on behalf of Mark, Fram at CDC 2 quick questions. Uh, the first 1 given the emerging signal and cmic, positive patients in both the lung and breast that you presented today. How are you thinking about incorporating cmic biology, going forward into future trial designs? Uh, do you see like, for example, in in your registration strategy that it evolving into some sort of biomarker and Rich program with maybe a

A more narrow, you know, patient selection. Um and then I'll ask my second 1 after

Alan Auerbach: Hi, Salvatore, this is Alan. You're absolutely right. We are seeing a much better signal in the patients where there's a signal of c-MET in, you know, positivity, if you will, using that in a broad sense. In small cell lung, you know, you don't have the benefit of a lot of the kind of predetermined disease-driven, you know, categories like you do in ER-positive breast. That likely may, you know, require some form of a c-MET positive. Now, is that gonna be like a, you know, c-MET positive, which includes copy number or percent of cells? I think we need a little more data to say that.

Yeah, I saw through this Allen. Um, so you're absolutely right. We are seeing a much better signal in the patients where there's a signal of cmic in uh you know, positivity if you will uh using that in a broad sense.

In small cell lung. Um,

you know, you don't have the benefit of a lot of the kind of predetermined diseased driven, uh, you know, categories like you do in ER, positive breast.

Alan Auerbach: I think we're hopeful, you know, that as we increase dose, we may get in the overall population, you know, we may continue to see that signal in c-MET, but in the overall population, we may see it as well, so we may be able to go for something a little more, you know, general. I think likely if we went for a biomarker focused in small cell lung, it would be something that's probably gonna be inclusive of a number of different categories of c-MET, you know, positivity, if you will. Now, in ER-positive breast, HER2-negative, ER-positive breast, you know, we've got a very interesting situation because you're absolutely right, it is a c-MET-driven signal.

So that likely make, you know, uh, require some form of a a semicolon. Now is that going to be like a, you know, cmic positive, which includes copy number or percent of cells. I think we need a little more data to say that. Um, I think we're hopeful, you know, that as we increase dose, we may get in the overall population. Um, you know, we may continue to see that signal in cmic, but in the overall population, we may see it as well. So we may be able to go for something a little more, you know, General. But I think likely that would, if we went for a biomarker focused in small cell lung, it would be something that's probably going to be inclusive of a number of of different categories of cmic, you know, positivity if you will

Alan Auerbach: For whatever reason, we're seeing an enrichment of that signal in the patients who are ESR1 mutated and PIK3CA wild type or both. You know, if I remember this correctly, ESR1 wild type is probably 50% to 60% of the patients. I'm sorry. PIK3CA wild type is probably 50% to 60% of the patients. ESR1 mutated is about 40% to 50%, so it's quite a big number. Now, if we look at the patients that are in the both category, which is where we're seeing, you know, especially at the 50-milligram dose, really compelling activity with no patients having progressed, you know, that's about 20% of the patients there. You know, it's a 40,000 patient population.

Now, an ear positive breast, her2 negative, ER, positive breast. You know, we've got a very interesting situation because you're absolutely right. It is a seam mix driven signal, but for whatever reason, we're seeing an enrichment of that signal and the patients who are esr1 mutated and pick 3, say a while or Pick 3, say a wild type or both.

Alan Auerbach: If that 8,000 patient population is the one that we focus on, I'm totally okay with that. It could be a fantastic benefit. I think for right now, it looks like in ER-positive breast, we have the benefit of just having enrichment of c-MET in, you know, categories where the disease is, you know, it's already being the biomarker, if you will, is already being determined. You know, they already know post-CDK4/6 standard of care is, you know, to do either tissue-based or ctDNA or both to see are you know, PIK3CA wild type, PIK3CA mutated? Are you ESR1 wild type or ESR1 mutated? We kind of have the benefit of that already being done for us. I think in ER-positive breast, that's probably the path we're going down.

Right. So, you know, uh, if I remember this correctly esr1 wild type is probably 50 to 60% of the patients. Um, I'm sorry, uh, Pick 3 CA wild type is probably 50 to 60% of the patients. Esr1 mutate is about 40 to 50%, so that's quite quite a big number. Um, now if we look at the patients that are in the both category, which is where we're seeing, you know, especially at the 50 milligram dose really compelling activity with no patients, having progressed, you know, that's about 20% of the patients there. So, you know, it's a 40,000 patient population.

if that's 8,000 patient population is the 1 that we focus on, I I'm I'm told okay with that, it's, it could be a fantastic benefit so I think

For right now, it looks like an ER positive breast.

We have the benefit of just having enrichment of CMIC in, you know,

Alan Auerbach: You know, they already know post-CDK4/6 standard of care is, you know, to do either tissue-based or ctDNA or both to see are you know, PIK3CA wild type, PIK3CA mutated? Are you ESR1 wild type or ESR1 mutated? We kind of have the benefit of that already being done for us. I think in ER-positive breast, that's probably the path we're going down.

categories where the, the diseases, you know, it's already being the biomarker. If you will, is already being determined, you know, they already know posted, k46 standard of care is, you know, to do, uh, either tissue based or ctna or both to see, are you, you know, Pick 3 to say, wild type Pick, 3 is a mutated? Are you ESR? 1 mile type or esr1 mutated. So we kind of have the benefit of that already being done for us.

Alan Auerbach: Obviously, we got to get more data, but I think that's kind of the initial thoughts on that.

So, I think in in ER, positive breast, that's probably the path we're going down.

Salvatore Caruso: Awesome. That helps a lot. Thank you very much. Just, like a quick second question. You know, looking ahead to the next updates in both programs, can you maybe kind of help ballpark for us what specific outcomes would give you guys confidence to advance or keep progressing these programs or advance even to the next stage of development?

Obviously, we got to get more data, but I think that's kind of the initial thoughts on that.

Awesome. That helps a lot, thank you very much. And just a quick second question: you know, looking ahead to the next updates in both programs—can you hear me?—can you help ballpark for us what specific outcomes would give you guys confidence to advance or keep progressing? These programs are advanced, even to the next stage of development.

Alan Auerbach: Yeah. In terms of advancing the next stage of development, we're all systems go on both. You know, at this juncture, I don't see any data that would tell us we're not continuing this into, you know, phase III. I think the question is just, what's the design? As you referenced in your earlier question, you know, what's the exact patient population to focus on? I think what we're looking for is gonna be, you know, more patient numbers and then more duration.

Yeah. Uh, so in terms of advancing, the next day's development, we're all systems go on both. Um, you know, at this juncture I don't see any data that would tell us. We're not continuing this, uh, into you know, phase 3. I think the question is just

What's the design? And you know, as you referenced in your earlier question, you know, what's the exact patient population to focus on? So I think what we're looking for is going to be, you know, more patient numbers and then then more duration

Salvatore Caruso: Okay. Great. Thank you.

Alan Auerbach: Sure.

Hello great. Thank you.

Sure.

Operator: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Mariann Ohanesian for any closing remarks.

Thank you. This concludes our question and answer session, and I would like to turn the conference back over to Marianne for any closing, remarks.

Mariann Ohanesian: Thank you all for joining us today. As a reminder, this call may be accessed by a replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.

Thank you all for joining us today as a reminder, this call may be accessed by a replay of the webcast at Puma biotechnology, cam beginning, later today, have a good evening.

Operator: Thank you, ladies and gentlemen. Thank you for participating in today's conference call. This concludes our program. Everyone have a great day and you may now disconnect.

everyone have a great day and you may now disconnect