Puma Biotechnology Inc · NASDAQ:PBYI
Puma Biotechnology — Investor Presentation (January 2022)
52 slides from Puma Biotechnology's investor presentation, Jan 10, 2022
Slide 1: Puma Biotechnology Corporate Presentation
Puma Biotechnology Corporate Presentation January 2022
Slide 2: Forward-Looking Safe-Harbor Statement
Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could ca
Slide 3: Product Pipeline
‘oduct Pipeline Phase lll Registration Approval HER2+ Breast Cancer Extendedadjuvant ExteNET (Phase Ill HER2+ EBC") Neratinib monotherapy CONTROL Metastatic NALA (Phase lll 3 Line HER2+ MBC”) Monotheray eo ee FB-10: T-DMi+neratinib TBCRC-022 (T-DM1 + neratinib) Metastatic w/ brain mets ‘Monotherapy
Slide 4: Specialty Pharmacy and Distributor Network
icy and Distributor Network _ Hub Services Specialty Pharmacy Network (SP) PumaPatientl y nix Acaria Health | Accredo A — cvs | ‘ONCO 360 i) Patients seams, | Blotogies Sites of Care Specialty Distributor Network (SD) McKesson ASD/Oncology Supply DMS Pharmaceutical Group Inc. Cardinal Health |
Slide 5: $43 Million net NERLYNX revenue in Q3'21
$43 Million net NERLYNX revenue in Q3’21 Quarterly Net Revenue (in $MM) 58.7 538 53.5 486 © 48.8 0.0 8 43.4 7 sl ] lI Ml} | Ps on™ oy 7 no os® on ge 20? oe? oo” os” on™ oo op 2 on™ on Ra oo os
Slide 6: 3,454 Ex-factory bottles were sold in Q4'21
3,454 Ex-factory bottles were sold in Q4’21 Bottles Sold (SP + SD) by Quarter 5,538 4799 4936 4791 ggoe 433° 4,452 - 4,035 3,728 3,517 W728 3,611 3,585 3,247 3,354 pied 2,947 2,137 675 | srt g0Kt ig 0X® eg QX® eg GK® ig GK® gt ng 0A® wg 08® ng GK? ug 2 gO 9629 629 ig 02* 902 ug 02 go?" BPE HE GABE P
Slide 7: Field Structure Adapted to Virtual Environment
to Adapt to Virtual Environment Prior Field Structure CurrentField Structure | | Regional Business Director (7 total) | eS ¥ Regional Manager | (10 total) | ia “ T 3h Strategic Account. Clinical Specialists | | ‘ove Managers (71 total) | Clinial Specialists
Slide 8: Patients started at a reduced dose
724 started at a reduced dose* ** % of Patients starting at reduced dose 56.5%"* 42.4% 37.7% 38:7% 32.8% 304% 30.8% 23.4% 19.0% 120% soa 6.3% 6 —o— oe a oo on™ oo oe oo os oo oo? oo? os? oo oo oo os” oo oo oo “Reduced dose defined as fewer than 6 pills per day “* FDA approved dose-escalation label s
Slide 9: Regional Partners and Regulatory Approvals
Region Partner Australia / SE Asia 6 ee isis MEDISON Canada “Knight Latin America Deir euanma Europe Greater China Middle East _) North and West Africa Pierre Fabre South Africa Turkey South Korea BIXINK Regulatory Approvals 2019 - Ext. Adj. in Australia, Singapore 2020 - Ext. Adj. in Brunei, Malays
Slide 10: CONTROL Study Design
CONTROL Study Design Phase 2 trial to characterize the incidence and severity of diarrhea in patients with HER2+ early breast cancer treated with neratinib and loperamide prophylaxis + an investigational agent 1 year of therapy n Melos G ne + Received up to 1 year of adjuvant trastuzumab + Stage I-3
Slide 11: CONTROL Study Flowchart
CONTROL Study Flowchart Population Cohort Treatment E Loperamide cohort (Original protocol) Neratinib Loperamide prophylaxis Final analysis (N=137) Stage 1-3c HER2+ breast cancer Trastuzumab-based adjuvant therapy completed within 1 year Sequential investigational cohorts Budesonide cohort Colestipo
Slide 12: CONTROL vs ExteNET: Neratinib Treatment-Emergent Diarrhea
CONTROL vs ExteNET: Neratinib Treatment-Emergent Diarrhea Loperamide prophylaxis reduces incidence and severity of diarrhea CONTROL! ExteNET® Neratinib dose Budesonide Colestipol + escalation + Loperamide Loperamide + loperamide le loperamide prn loperamide pm pm (n=137) (n=64) 6) | (n=1408) Treatme
Slide 13: Adjuvant HER2+ Breast Cancer Market Size
uvant HER2+ Breast Cancer Market Size @ Approximately 28,300 patients (US) with early stage HER2+ breast cancer treated with adjuvant treatment? @ Approximately 6,000 patients (US) with HR positive early stage HER2+ breast cancer and no pathological complete response to neoadjuvant treatment (high r
Slide 14: NALA Study Design: 3rd- or later-line HER2+ mBC
™ 3rd- or later-line therapy for patients with HER2+mBC & Patients with asymptomatic CNS metastatic disease are eligible ™ Obtained SPA from FDA and review by EMA in February 2013 HER2+ mBC Received 22 prior lines of Follow-up HER2-directed therapy \ (Survival) STUDY OBJECTIVES Co-Primary: PFS (cent
Slide 15: NALA: Progression-free survival
Hazard ratio Log-rank 094 (95% Cl) p-value ost * — Neratinib + Capecitabine - ani... 0-76 (0.63-0.93) 0.0059 — Lapatinib + Capecitabine PFS probability ° f T T T 0 3 6 9 12 15 18 24 24 27 30 33 36 Time since randomization (months) 183113 69 54 35 20 13 9 7 3 2 2 183 82 39 24 9 8 3 2 2 2 2. 1 Sauract
Slide 16: HER2+ MBC (NALA): Study Results
PFS probability ° f | res ie HER2+ MBC (NALA): Study Results stricted means analysis — PFS Mean PFS (months) —_ p-value — Neratinib + Capecitabine 88 0.0003 — Lapatinib + Capecitabine 66 Restriction: 24 months 183 183 13 82 T T T 15 18 24 24 27 30 33 Time since randomization (months) 35 20 13 9 7 3
Slide 17: NALA: Overall survival
Mean OS Hazard ratio —_Log-rank (months) (95% Cl) p-value —Neratinib +Capecitabine 24.0 0.88 (0.72-1.07) 0.2086 07 —Lapatinib +Capecitabine 22.2 2 2 os 3 Restriction: 48 months 2 os- a Q 044 ° 037 024 0474 0 ™—1—T Te T To T—1—1—T T T T T 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 R Time
Slide 18: NALA: Cumulative incidence of CNS interventions
4 A Cumulative incidence (%) 100-4 Neratinib +Capecitabine _Lapatinib + Capecitabine Intervention (n=65/307) (n=75/314) Radiation therapy 11% 15% ‘Surgery/procedure 2% 3% Anticancer medication 1% 1% Overall cumulative incidence (Gray's test): 22.8% vs 29.2%; p=0.043 - — Neratinib + Capecitabine 4 —
Slide 19: HER2+ MBC Market Size
:-R2+ MBC Market Size @ Approximately 6,400 patients (US) with third-line HER2+ metastatic breast cancer and 4,700 patients (US) with fourth-line HER2+ metastatic breast cancer’ ‘Roche epidemiology slides 09/18
Slide 20: FB-10 Phase I/II Trial of Kadcyla + Neratinib
FB-10 — Phase I/Il Trial of Kadcyla (T-DM1) + Neratinib HER2+ MBC Neratinib Dose level 1: 120 mg/d Dose level 2: 160 mg/d Dose level 3: 200 mg/d Dose level 4: 240 mg/d Must have received prior anti-HER2-based therapy with pertuzumab for mBC No prior T-DM1 or HER2 T-DM1 TKI allowed 3.6 mg/kg IV d1 Q3
Slide 21: FB-10 Trial Results
rial of Kadcyla (T-DM1) + Neratinib 240 240 “Off TX, AEIwithdrawn sat + On treatment os ORR (CRIPR): 12 of 20 (60%) 160 160 cR PR sD PD 360 160 160 Dose mg/d 160 160 160 320 120 320 120 120 ° 100 200 300 400 500 600 700 800 Days on Treatment
Slide 22: TBCRC 022: Neratinib in HER2+ Breast Cancer with Brain Metastases
TBCRC 022: Phase Il Trial of HKI-272 (Neratinib) for Patients with HER2+ Breast Cancer and Brain Metastases if Progressive } brain mets Craniotomy candidates | Progressive brain mets: a: No prior lapatinib 3b: Priorlapatinib Cohort 1 (n = 40 pts) Cohort 2 (n= 5 pts) Cohort 3a (n = 39 pts) Cohort 3b
Slide 23: Reduction in volume of CNS lesions
% reduction in volume of CNS lesions -022 Cohort 3a Best Volumetric Response (n=31)* ° ry 8 & re
Slide 24: Neratinib Included in NCCN Guidelines for CNS Metastases
Neratinib Recently Included as a Treatment Option for Recurrent Breast Cancer CNS Metastases By NCCN® Guidelines’ Guidelines updated March 2020 Category 2A: Category 2B: Neratinib + Capecitabine Neratinib + Paclitaxel TBCRC 022? NEfERT-T?+ A Phase |! Trial of Neratinib and Randomized, Multi-Center,
Slide 25: SUMMIT Basket Trial Design
EGFRexoni8- Primary endpoint * Objectiveresporserateat fins post-baseine tumor azzesamert (ORR, =), Neratinib ;otherapy Secondary endpoints + ORR confirmed) + Clinical beneferate(CeR) + Progression ee survival PFS) + Sate + Biomarker = wos Neratinib Bladder == | Simon 2-stage desion * tf21 response
Slide 26: SUMMIT: Breast Cancer Cohort
SUMMIT Breast Cancer Cohort
Slide 27: Characteristics of HER2-mutant breast cancer
Characteristics of HER2-mutant breast cancert® pincisence | Histology Pcenomics | * 2% Primary breast cancers * Predominantly in hormone * Occur across multiple domains * 2-4% MBC receptor-positive (luminal-A) of the protein (KD, ECD, TMD) and HER2-negative tumors * Most common variants: * 8% ER+ MB
Slide 28: Current SUMMIT breast cancer cohorts
Current SUMMIT breast cancer cohorts + Added inclusion criteria for HR+ cohort to reflect current standard of care: prior CDK4/6 inhibitor therapy HER2-mutant MBC MBC cohort Treatment assignment HR#HHER2-negative MBC aeeuceised, ———= (| Non-randomized Neratinib + Fulvestrant [ + Trastuzumab ° HR+HER
Slide 29: HR+ non-randomized N+F+T: Efficacy findings
HR+ non-randomized N+F+T w prior CDK4/6i: Efficacy findings Objective response (confirmed CR/PR)*, n (%) 12 (46.2) cR 0 PR 12 (46.2) Best overall response 45 (677) (confirmed or unconfirmed PR or CR), n (%) Median DOR®, months (95% Cl) 14.4 (6.4-NE) Clinical benefits, n (%) 15 (57.7) Median PFS, mon
Slide 30: HR+ randomized cohorts: Efficacy findings
HR+ randomized cohorts: Efficacy findings Neratinib appears to be critical for inhibition of HER2 mutations Randomized cohort rn eee eu set Objective response (confirmed CRIPR)°, n (%) 2 (28.6) 0 0 cR 4 (14.3) 0 0 PR 4 (14.3) 0 0 Best overall response (confirmed or unconfirmed PR or CR), n (%) ie) @
Slide 31: TNBC cohort: baseline characteristics and efficacy
TNBC cohort: baseline characteristics and efficacy Baseline characteri ECOG performance status, n (%) Objective response (confirmed CR/PR)?, n (%) 6 (33.3) 0 9 (60.0) CR 1 (6.6) 1 9 (50.0) PR 5 (27.8) - = Best overall response 7 (38.9) Histological type, n (%) (confirmed or unconfirmed PR or CR), n
Slide 32: Change in tumor size and characteristics
Change in tumor size (target lesion) and characteristics Noandonzod Randonizad —-Rangonied Randomized te ee ee ee Por CDK a6: Plot COKWS! Prior CDKAI Prior COKALE mec Nore NPT fr F Ne 100 HER2 mutation category Il nase coman notspot Til Kinase domain hosp; nor hotspot Bl on 20 inerton Il nase coman
Slide 33: Change in tumor size and characteristics
Change in tumor size (target lesion) and characteristics Nontandenizod Randomized Randomized Randomized ait 1 HR pa or CDK Por CDKWS Prior COKE Prior COKAL Tec NPT NPT er F wr Bost overall response 1004 HER@ mutation category i Il Kase omain nospet Til Kinase domain hosp; nor hotspot Hl &1en 20 nser
Slide 34: N+F+T demonstrated encouraging clinical activity
The combination of N+F+T demonstrated encouraging clinical activity in patients with heavily pretreated HR+, HER2-negative, HER2-mutant MBC who had previously received CDK4/6: — Objective response rate 42.4% (1 CR and 13 PRs); median PFS 7.0 months, n=33 Following guidance from the Independent Data
Slide 35: SUMMIT: Cervical Cancer Cohort
SUMMIT Cervical Cancer Cohort
Slide 36: HER2-Mutant Cervical Cancer
HER2-Mutant Cervical Cancer 5% metastatic cervical cancers ™ Enriched in adenocarcinomas Most common HER2™* is $310 lm May be negatively prognostic for High occurrence in HPV+ tumors ‘extracellular’ domain: hotspot: mutation survival ™ Usually exclusive to HER2 amplifications = Most common co-mutati
Slide 37: Best change from baseline (%)
Best change from baseline (%) 100 -50 = 100 8B 8 8 BB Pestresponse BEGOB 888808 Oo Om COO Bi Piwscaco.mutaton -KRASco-mutaton Histology P53 co-mutation I Transmombrane domain hotspot Best response (RECIST v1.1) Histotooy Oncology Gynecologic Oncology, 2020
Slide 38: Response over time in cervical cohort
onm | @) or e Vv vstenerea > @ onw | @N ° sonnet [| - © Compete response (PET) Partial response (RECIST) sor @ Stable disease (RECIST) @ Progressive disease (RECIST) 0 6 12 18 24 30 36 42 Time (months) Gynecologic Oncology, 2020
Slide 39: SUMMIT Basket Trial: EGFR exon 18 lung cancer cohort update
SUMMIT (PUMA-NER-5201) Basket Trial EGFR exon 18 lung cancer cohort update
Slide 40: Lung Cancer Cohort Receiving Neratinib: Patient Characteristics
ancer Cohort Receiving Neratinib raphics and Patient Characteristics Patient characteristics SafetylEfficacy evaluable patients (n° Median (range), years 67 (56-83) <65 years, n (%) 4 (38) 265 years, n (%) 7 (64) Gender, n (2%) Female 5 (45) Male 6 (68) EOS performance status, n (%) 5 (48) 6 (65) 1
Slide 41: Efficacy Parameters
Parameter (Objective response (confirmed),¢ n 4 4 cR 0 0 PR 4 4 Objective response rate, % (95% Cl) 36 (11-69) 40 (12-74) Best overall response, n 6 6 cR i) ') PR 6 6 Best overall response rate, % (95% Cl) ‘54 (23-83) 60 (26-88) % 7.5 (4.0-NE) 7.5 (4.0-NE) ese OR morte CRS (1.9", 4.0, 7.5, 8.2") (19
Slide 42: Duration of Treatment and Tumor Change
0902 (67194) 0711 719x)4 0758 (6719x)-4 0712 (6719x, $768) | © 1910 (G7196; 768i, 1790M) | © 7904 (G719x; $768) 1900 (67194; E7094) 1907 (67196; s768) 4 5052 (€709_T710deins0; FGFRamp)-] 08 = Duration of Treatment > Ongoing Treatment tector ug > (eo) 7902 (G719¢; £703) =a | —> fe] Le] 185 6719x: 876
Slide 43: Response Rates With Afatinib in Uncommon Mutations
Ons Table 3. Response Rates With Afatinib in Patients With NSCLC Harboring Uncommon Mutations ‘Mutation Type CR, n (%)_PR, 1 (%) SD, n(%) PD, n (%) DCR, n (%) ORR,n (%) DOR, Mo (95% Cl) EGFR TKI naive patients ‘Major uncommon mutation (n= 110) 61 (55.5) _35.(31.8)_9(8.2)__101 (91.8) 47.4 (11.0-20.8)
Slide 44: Neratinib in EGFR Exon 18-Mutant Lung Cancer Cohort
‘atinib in EGFR Exon 18-Mutant ncer Cohort in SUMMIT Study ™@ The success criteria for the 18 stage and 2™ stage of the Simon's 2-stage design has been met — Enrollment in the 2" stage is continuing up to a total of 30 patients @ Anticipate presentation of additional data from SUMMIT in patients wit
Slide 45: Expected Milestones
— Expected Milestones Conduct pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated HR+ breast cancer (H1 2022) Report Phase II data from cohort of patients in SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H1
Slide 46: Neratinib patent portfolio
@ Composition of matter patent issued (expires 2030) — Extended by USPTO in November 2021 per Hatch/Waxman @ Use in the treatment of cancer issued (expires 2025) @ Two polymorph patents issued (both expire 2028) @ Combination with capecitabine (expires 2031) @ Use in extended adjuvant breast cancer
Slide 47: Intellectual Property on EGFR T790M Mutations
gis Property on EGFR T790M Mutations @ Issued claims in Europe, Asia, Australia (expires 2026) — Possibility to extend up to 5 years m Issued claims in United States (expires 2026) @ Patent claims upheld after European Opposition Hearing (February 2014) ® Patent claims upheld after Appeal to Europea
Slide 48: Management Team
iced Management Team Alan H. Auerbach Chairman, Chief Executive Officer, President, Founder - Chief Executive Officer, President, Founder, Cougar Biotechnology Jeff Ludwig Chief Commercial Officer ~ Eli Lilly, Astellas, Amgen Maximo F. Nougues Chief Financial Officer ~ Getinge AB, Boston Scientific,
Slide 49: Board of Directors
rd of Directors AlanH. Auerbach Chairman, Chief Executive Officer, President, Founder, Puma Biotechnology, Inc. Allison Dorval CFO, Verve Therapeutics; Former CFO Voyager Therapeutics, Inc.; VP and Controller, Juniper Pharmaceuticals, Inc. Michael Miller Former EVP U.S. Commercial, Jazz Pharmaceutic
Slide 50: Currently trading on: cash and financing
‘ | Currently trading on NASDAQ: PBYI Cash, cash equivalents and marketable securities at September 30, 2021: ~$87.5 million Cash burn in Q3 2021: ~$21.4million Note purchase agreement (July 2021) — Fund managed by Athyrium Capital Management — New agreement for $125 million replaces loan of $100 mi
Slide 51: Company Highlights
ipany Highlights @ NERLYNX® - first HER2-directed drug approved by FDA for extended adjuvant treatment of early-stage HER2+ breast cancer in patients who have received prior trastuzumab ™ NERLYNX® — first HER2-directed tyrosine kinase inhibitor approved in both early stage and metastatic HER2+ breas
Slide 52: Puma Biotechnology
Puma Biotechnology Corporate Presentation January 2022
Puma Biotechnology — Investor Presentation (January 2022) on 6ix