The US Breast Cancer Market

1. www.sganalytics.com The US Breast Cancer Market Current status, treatment options, opportunities, pipelines and perceptions SGA Edge We combine the energy of a young company with institutionalized delivery prowess of large companies. We create AI applications across Healthcare sales and marketing processes to deliver an average efficiency impact of 50%+ We deliver impactful ROI improvement through our data management, strategy and predictive reporting engagements We quickly evolve to become your business partners via end-to-end ownership; we do this by bringing flexibility and a “skin-in the game” product mindset to our engagements www.sganalytics.com 1

2. The US Breast Cancer Market Table of Contents 01 1.1 1.2 1.3 1.4 1.5 Executive Summary Introduction Disease overview Current treatment landscape Drug pipeline Recent advancements for Breast Cancer management with a focus on novel techniques and combination therapies Key takeaways 1.6 02 2.1 Appendix Clicks, Likes, Shares and Comments – all about social media visibility on breast cancer (Impact of Social Media Analytics) Key deals in Breast Cancer segment About the author 2.2 2.3 www.sganalytics.com 2

3. The US Breast Cancer Market Executive Summary Introduction The addressable breast cancer market includes > 400,000 women patients that live with breast cancer in 2022 and an estimated 43,250 female and 570 male patients will die this year. It impacts both male and female and is growing Status – Epidemiology in 2022 New Hampshire, Connecticut, Hawaii, Rhode Island and Washington D.C. have the highest breast cancer incidence rates while, Nevada, New Mexico, Arizona, Texas and Wyoming have reported the lowest incidence rates The incidence rates have increased by 0.5% per year. Before COVID-19 led pandemic hit the region, there were an estimated 3,771,795 women living with female breast cancer (prevalence) in the United States in 2019. Currently it is estimated at 4,016,395 in 2022 Overall, the average risk of a woman in the United States developing breast cancer sometime in her life is about 13%. • • • Total Population of US till 2022 (May) 332,649,116 Expected new cases of Invasive Breast Cancer 287,850 Invasive Breast Cancer 13% New cases of non-invasive (in situ) Breast Cancer 51,400 A man’s lifetime risk of breast cancer 1 in 833 Expected to die from breast cancer 43,250 Women with a history of breast cancer in the U.S. before Jan 2022 3.8 million Newly diagnosed cancers in women 30% More common in women under 45 > in Black women Incidence & Mortality Rates Men Women Incidence rate (new cases per year) Mortality rate (deaths per year) 1.3 per 100,000 129.3 per 100,000 0.3 per 100,000 19.7 per 100,000 Chemotherapy can cost about $10,000-$100,000 or more, depending on the drugs, the method of administration and the length or number of treatments (average $7K-14K per treatment). Medicare covers chemotherapy for US patients (insured); Out-of-pocket costs are highest for breast cancer i.e., $3.14 billion (av $4.5K-5K per patient) Source: *https://www.komen.org/breast-cancer/facts-statistics/breast-cancer-statistics/; https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html; https://seer.cancer.gov/statfacts/html/breast.html www.sganalytics.com 3

4. The US Breast Cancer Market Disease overview Breast cancer is the malignant cells growth in the breast tissues; can be caused by inherited genetic mutations of BRCA1 and BRCA2 genes, exposure to radiation, obesity, and other reasons** Disease Classification • Ductal carcinoma In Situ – It is a non-invasive cancer that starts in ductal cells and not grown into the rest of the breast tissue. • Invasive breast Cancer – cancer cells which spread into surrounding breast tissue, these includes • Triple Negative Breast Cancer – It is an aggressive type of cancer in which cancer cells spreads to other parts of the body beyond the breast. cancer cells don’t have estrogen or progesterone receptors. • Inflammatory Breast cancer - It is an aggressive type of cancer in which cancer cells block lymph vessels in the skin • Peget Disease of Breast – cancer cells growth starts in the breast ducts and spreads to the skin of the nipple and then to the areola. • Angiosarcoma – Cancer cells growth starts in blood vessels or lymph vessels of the breast. • Phyllodes Tumor – Cancer cells growth starts in connective tissue (Stroma) of the breast. • (current molecular classification divides breast cancer into five groups as luminal A, luminal B, HER-2, basal and normal breast ) Diagnostic Tools (common) Interventions (common) Ultrasound – uses sound waves to make sonogram pictures of areas inside breast Mammogram – X-ray screening of breast lumps Breast MRI – It uses magnetic waves to deliver pictures of areas inside breast Biopsy – It is a test in which tissue or fluid removed from the breast to be looked at under a microscope (highly preferred) Surgery – An operation Involves cancer tissue resection Chemotherapy – Special drugs used to shrink or kill cancer cells. Hormonal Therapy – blocking cancer cells from getting hormones need to grow Biological Therapy – Uses body's immune system to kill cancer cells (stem cells though not approved are used in some part of world) Radiation Therapy - high-energy rays (similar to X-rays) to kill the cancer cells • • • • • • • • • Other interventions include - Serum CA125 is a predictive marker for breast cancer outcomes and correlates with molecular subtypes; ** Other reasons could be hormones, alcohol, etc. Source: CDC.gov www.sganalytics.com 4

5. The US Breast Cancer Market Current treatment landscape – Approved drugs in breast cancer In March 2022, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) HER-2 Positive TNBC Others In Oct 2021, Abemaciclib – brand name Verzenio – was approved for patients with the HR+, HER2-early breast cancer, which makes up 70% of all breast cancers Source: Company website; Fierce Pharma www.sganalytics.com 5

6. The US Breast Cancer Market Drug pipeline (1/2) – Phase II/III Roche, Gilead Sciences, Astra Zeneca, Merck and Pfizer are leading the breast cancer pipelines in 2022. The current US market size was estimated at $ 9.1 Billion (2021) with ~350 candidates in various stages of trials PARP Selective Estrogen Receptor Degrader (SERD) Veliparib /AbbVie Zejula/GlaxoSmithKline HER2/neu or ErbB-2 Amcenestrant/Sanofi Giredestrant/Roche Imlunestrant/Eli Lilly Cytochro me P450 AZD9833/AstraZeneca Zanidatamab/Zymework ZN-c5/Zentalis Pharmaceuticals Zytiga/Johnso n & Johnson NeuVax/SELLAS Life Sciences Group Rubraca/Clovis Oncology SM-88/Tyme Technologies TPIV 110/Marker Therapeutics Poziotinib/Spectrum Pharmaceuticals ARX788/Ambrx Bioharma Idasanutli/Roche ER1 or ER alpha/ER2 or ER beta Elacestrant/The Menarini Group Retifanlimab/Incyte Corporation Monoclonal Antibody DS-1062 /Daiichi Sankyo BI 836845/Boehringer Ingelheim GmbH Fablyn/Sermonix Pharmaceutical Opdivo/Bristol Myers Squibb Endoxifen/AtossaTherapeutics Imfinzi/AstraZeneca PLC Magrolimab/Gilead Sciences DHP107/Daehwa Pharmaceutical Co Ltd LAG525 /Novartis AG SYD985/Byondi s Eftilagimod Alpha/Immutep Docecal/Oasmia Pharmaceutical AB Sacituzumab govitecan- hziy/Gilead Pelareorep/Oncolytics Biotec Eganelisib/Infinity Pharmaceuticals Oral Paclitaxel/Athenex EndoTAG-1/SynCore Biotechnology Inavolisib/Roche Holding AG OBI-822/OBI Pharma IRX-2/Brooklyn ImmunoTherapeutics Microtubules (Tubulin) Capivasertib/AstraZe neca Immune System PI3K/AKT pathway FTD Clinical Trial Phase Phase III Phase II ROAs Oral IV SC Combination Intradermal Intratumoral Intramuscular Topical Key Takeaways FDA has granted fast track status to Cosela for triple-negative breast cancer A Phase III of adjuvant giredestrant vs. with physician’s choice of adjuvant endocrine monotherapy in patients with estrogen receptor-positive, HER2-negative early breast cancer is recruiting patients. • • Source: clinicaltrial.gov; trialtrove; company website www.sganalytics.com 6

7. The US Breast Cancer Market Drug pipeline (2/2) - by key players and stages of development Survival rates are climbing, diagnosis has increased, demand for precision medicine and new class of drugs are at an all time high Clinical Trial ID Treatment arms Key players Phase* Selective Estrogen Receptor Degrader (SERD) AMEERA-5 (NCT04478266) III SAR439859 + Ibrance Sanofi GDC-9545 + Letrozole-matched Placebo + Palbociclib vs Letrozole + GDC-9545-matched Placebo + Palbociclib BO41843 (NCT04546009) III Roche Monoclonal Antibodies Nivolumab combined with neoadjuvant CT and adjuvant ET vs Placebo combined with neoadjuvant CT and adjuvant ET CheckMate 7FL (NCT04109066) Bristol-Myers Squibb III Xentuzumab/everolimus/exemestane vs Placebo/everolimus/exemestane Boehringer Ingelheim Incyte Corporation Oncolytics Biotech NCT03659136 II NCT04445844 II Pelareorep + Retifanlimab Poly ADP-Ribose Polymerase (PARP) Clovis Oncology, Inc. BRE09-146 II Rucaparib + Cisplatin vs Cisplatin PI3K/AKT pathway CAPItello-292 (NCT04862663) Capivasertib + palbociclib + fulvestrant vs Placebo + palbociclib + fulvestrant III Astra Zeneca WO41554 (NCT04191499) GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant II Roche Microtubules (Tubulin) EndoTAG-1 + Paclitaxel + Gemcitabine Hydrochloride vs Paclitaxel + Gemcitabine Hydrochloride CT4005 (NCT03002103) III Syncrore HER2/neu or ErbB-2 Genentech /Sellas LS Group NCT01570036 II Herceptin + NeuVax vaccine * Above list is indicative and not total representation of clinical trials; in actual there are about 350 candidates in various phases of clinical trial (refer slide 7) Source: cliniicaltrial.gov.; triatrove www.sganalytics.com 7

8. The US Breast Cancer Market Recent advancements for breast cancer management with a focus on novel techniques & combination therapies (1/2) Currently, it is estimated that about 30% of newly diagnosed cancers in women will be breast cancers; hence it is imperative that breast cancer screening, diagnosis and therapy gets a quick uplift using AI, and modern technology Personalized Screening Wisdom Study is exploring how to best personalize breast cancer screening FDA approved lilly’s Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test Combination Therapies AI & Radiologists have started using artificial intelligence (AI) software to help them read mammograms better Mammograms Many nanoparticles have been developed, specifically targeting metastasized tumors of the breast. Tecentriq plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) is being used for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1+ TNBC.  Novel Drug Delivery  Recent advancements for breast cancer management with a focus on novel techniques & combination therapies (2/2) If the breast cancer is localized then survival rates can reach upto 99%; while if the cancer is regional (e.g., metastasis to neighboring/surrounding tissues), survival rates may reach upto 86%, hence novel treatment and diagnostic play important role in survival Targeted therapy with Combination Diagnostic Approval of targeted therapies with CDx has led to evidence-based therapies in breast cancer USFDA granted Fast Track designation (FTD) to gedatolisib (mTOR inhibitor), for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy. Emerging Therapies The year 2022 started a big bang in the best cancer segment, the identification of MAPK4 as a potential target for triple-negative breast cancer (TNBC), and a lasting survival benefit in HER2+ metastatic breast cancer from adding tucatninib to treatment with trastuzumab and capecitabine has created more options and more in-roads in treatment of breast cancer Source: Company websites, ASCO/ESMO Conferences www.sganalytics.com 8

9. The US Breast Cancer Market Clicks, Likes, Shares and Comments – all about social media visibility on breast cancer During the pandemic, virtual business models proved that online marketing, social media tools can create significant demand among users and educate them. Such analytics helps a company channelize their efforts in the right direction and optimize cost Pre-Covid Sentiments (till 2020) Results of a published report^ in 2019 highlighted that − Most participants were lay individuals as opposed to healthcare professionals or advocacy groups. − The lay misunderstandings surrounding the harms and benefits of mammography was well mirrored in the content of social media discourse. − Although there was criticism, breast cancer screening sentiment on the social media ranged from the neutral to the positive. − Such comments were randomly seen on Facebook, Twitter, YouTube and QUORA that were usually considered for data collection by many research agencies − Key studies on social media analytics also reported that there was lay confusion surrounding breast cancer screening in social media discourse • “Non-healthcare users comprise a significant proportion of participants in mammography conversations, with tweets often containing claims that are false, not explicitly backed by scientific evidence, and in favor of alternative “natural” breast cancer prevention and treatment. Nastasi A study (2018) Current Sentiments (2022) News feeds such as the death from COVID-19 of a mom of 6 who survived breast cancer (repeated four times), trial vaccination against breast cancer were common topics that were discussed during the lockdown. • Pink October (Breast cancer awareness month) is more visible on social media than ever. • Celebrities with breast cancer, including the North-American actress Shannen Doherty, the British-Australian singer Olivia Newton-John, and the North-American television broadcaster Robin Roberts were vocal about breast cancer on social media and created awareness. • (Data sources changed from traditional to more credible ones - Facebook shares; Twitter shares; Pinterest shares; Reddit engagements, podcasts and conference) • Breast cancer drug breakthrough may save thousands of lives: Trial reveals existing medicine cuts risk of most aggressive type of disease returning by 37% . @sandieshoes, Feb 10 Source: ^https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231422; Nastasi A et al, Journal of Cancer Education. 2018;33(3):695–702. pmid:28097527 www.sganalytics.com 9

10. The US Breast Cancer Market Key deals in Breast Cancer segment Eisai Co., Ltd. and Bristol-Myers Squibb Company entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202 in Jun 2021 Timelines Key Deals that will impact the Breast Cancer Market in 2022-23 Celcuity, Inc. entered into a global licensing agreement with Pfizer, Inc. granting Celcuity exclusive worldwide rights to develop and gedatolisib. Celcuity will pay $10 million as upfront payment, $330 million in development and sales-based milestone, and tiered royalties on potential sales. (Source) April 2021 Clarus Therapeutics, Inc. and HavaH Therapeutics entered into a licensing agreement whereby Clarus will acquire the exclusive worldwide (excluding Australia) development and commercialization rights for HAVAH T+Ai (CLAR-121). Clarus will pay HavaH $500,000 as an upfront payment, $10.75 million in potential development and regulatory milestones, and $30 million in potential commercial milestones. (Source) May 2021 Eisai Co., Ltd. and Bristol-Myers Squibb Company entered into an exclusive global strategic collaboration agreement for the co- development and co-commercialization of MORAb-202. BMS will pay $650 million upfront and $2.45 billion in potential future development, regulatory, and commercial milestones to Eisai. (Source) June 2021 Arvinas, Inc. and Pfizer, Inc. entered into a global collaboration to develop and commercialize ARV-471. Pfizer will pay Arvinas $650 million upfront, $400 million in approval milestones, up to $1 billion in commercial milestones, and a $350 million equity investment in Arvinas. (Source) July 2021 Seagen, Inc. and RemeGen Co., Ltd. entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin. Seagen will pay RemeGen $200 million upfront, and up to $2.4 billion in potential total milestone payments and a tiered, high single-digit to mid- teen percentage royalty based on net sales. (Source) Aug 2021 Sources: Company website www.sganalytics.com 10

11. The US Breast Cancer Market Key Takeaways More than 350 drugs are in pipeline and the market is projected to grow at a CAGR of 8- 9% till 2025, the US breast cancer market is a high opportunity segment, fuelled by high competition and strong payer perception* Daiichi Sankyo is expected to present updated safety data from the Phase III DESTINY-Breast03 (HER2+) trial evaluating Enhertu in HER2-Positive, uresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane at the ASCO annual meeting being held June 3-7, 2022. AstraZeneca anticipates submission of a regulatory approval application for Enhertu for the treatment of breast cancer based on DESTINY-Breast03 data to the Chinese authorities in the first half of 2022. Radius plans on proceeding with regulatory submissions in both the United States and the European Union expected in the second quarter of 2022. • Market attractiveness • • Sanofi has started enrollment of Phase III AMEERA-6 trial of amcenestrant for patients with HR+ early breast cancer Oncolytics Biotech is investigating pelareorep with various combinations in metastatic and early-stage breast cancer Athenex’s oral paclitaxel in combination with check point inhibitors is still under investigation • Strong Drug Pipeline • • FDA approved Verzenio in Oct 2021 for patients with the HR+, HER2- early breast cancer, which makes up 70% of all breast cancers. Keytruda was approved in for high-risk, early-stage triple- negative breast cancer in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery, high competition expected • High Demand & Higher competition • Source: Company websites, investor presentation * refer appendix for social media perception www.sganalytics.com 11

12. The US Breast Cancer Market About the Authors Dr. Siddhartha Dutta, Practice Head, Healthcare Dr. Siddhartha Dutta has been working in the healthcare industry for the last 22 years. He has been involved with clinical trials, medical research, planning, and various roles in public and private healthcare domains. He has extensively worked in South East Asia (including Japan), and key markets such as Europe and the US. As a medical microbiologist, he began his career in hospital reference laboratories in the US & India, and has been helping industry clients since 2007. He is a writer, blogger and strategist and has represented his industry on various platforms of international repute. His current areas of interest are AI in Healthcare, vaccines, femtech, infoproducts, patient data convergence and market access. sidhartha.dutta@sganalytics.com About SGA SG Analytics, a Great Place To Work (GPTW) certified company, is one of the leading research and analytics firms to offer data-centric research and contextual analytics services. With presence in the US, the UK, Switzerland, and India, SG Analytics has been consistently meeting and exceeding customer expectations by its knowledge-based ecosystem and impact-oriented solutions. www.sganalytics.com GET IN TOUCH New York | Seattle | San Francisco | Austin | London | Zurich | Pune | Hyderabad | Bengaluru www.sganalytics.com 12