Full Press Release Details
Presentation July 2021
Disclaimer and Forward-Looking Statement Certain statements in this
presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of Biomea Fusion, Inc. (the "Company") and involve known and unknown risks,
uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some
cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate,"
"intend," "believe," "estimate," "predict," "potential" or other comparable terminology. All statements other than statements of historical fact could be deemed forward-looking, including
any projections of financial information or profitability, the initiation, timing and results of pending or future clinical trials, the actions or potential action of the FDA, the status and timing of ongoing research, corporate partnering
activities, any statements about historical results that may suggest trends for the Company's business; any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding
future events, potential markets or market size, or technology developments, and other factors affecting the Company's financial condition or operations. The Company has based these forward-looking statements on its current expectations,
assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward- looking statements are only predictions and involve known and unknown risks and
uncertainties, many of which are beyond the Company's control. These and other important factors may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The
forward-looking statements in this presentation are made only as of the date hereof. Except as required by law, the Company assumes no obligation and does not intend to update these forward-looking statements or to conform these statements to actual
results or to changes in the Company's expectations. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves
a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate
are necessarily subject to a high degree of uncertainty and risk. 2Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to
future events or the future financial performance of Biomea Fusion, Inc. (the "Company") and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or
achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may,"
"will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict,"
"potential" or other comparable terminology. All statements other than statements of historical fact could be deemed forward-looking, including any projections of financial information or profitability, the initiation, timing and results
of pending or future clinical trials, the actions or potential action of the FDA, the status and timing of ongoing research, corporate partnering activities, any statements about historical results that may suggest trends for the Company's business;
any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding future events, potential markets or market size, or technology developments, and other factors affecting
the Company's financial condition or operations. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and
projections are reasonable, such forward- looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors may cause actual results,
performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this presentation are made only as of the date hereof. Except as required by law, the Company
assumes no obligation and does not intend to update these forward-looking statements or to conform these statements to actual results or to changes in the Company's expectations. This presentation also contains estimates and other statistical data
made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition,
projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. 2
Irreversible Drug Discovery & Our Mission is to revolutionize drug
development Development Platform in order to create more effective therapies for patients in need. Three Innovative Programs Announced to date Biomea Fusion is a preclinical-stage biopharmaceutical company focused on the discovery and development of
irreversible small-molecule drugs to treat patients with Menin Lead Product Candidate genetically defined cancers. Our discovery team is in IND-enabling Studies engaged in all phases of development, including target selection, small molecule design,
and preclinical and clinical studies to develop innovative medicines. Liquid & Solid Tumor Targets 3Irreversible Drug Discovery & Our Mission is to revolutionize drug development Development Platform in order to create more effective
therapies for patients in need. Three Innovative Programs Announced to date Biomea Fusion is a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small-molecule drugs to treat patients with Menin
Lead Product Candidate genetically defined cancers. Our discovery team is in IND-enabling Studies engaged in all phases of development, including target selection, small molecule design, and preclinical and clinical studies to develop innovative
medicines. Liquid & Solid Tumor Targets 3
Biomea Fusion History A Discovery Platform in Development since 2017
Biomea and A2A form Lead candidates Initial Public Offering 2018 2020 Biomea Fusion to develop selected for menin (NASDAQ: BMEA) MLL-Fusion and menin Raises $158 M at $17/share reversible menin Program dependent cancers JPMorgan, Jeffries, Piper
Sandler F u s io n Biomea becomes a JLABS, Biomea receives Series A South San Francisco Syndicate financing of $56M resident to support the development of Biomea's portfolio of 2021 2019 2017 irreversible inhibitors Biomea builds out its proprietary
irreversible binding technology 4Biomea Fusion History A Discovery Platform in Development since 2017 Biomea and A2A form Lead candidates Initial Public Offering 2018 2020 Biomea Fusion to develop selected for menin (NASDAQ: BMEA) MLL-Fusion and
menin Raises $158 M at $17/share reversible menin Program dependent cancers JPMorgan, Jeffries, Piper Sandler F u s io n Biomea becomes a JLABS, Biomea receives Series A South San Francisco Syndicate financing of $56M resident to support the
development of Biomea's portfolio of 2021 2019 2017 irreversible inhibitors Biomea builds out its proprietary irreversible binding technology 4
Biomea's Team Diverse team with significant drug development
experience Taisei Kinoshita Naomi Cretcher Heow Tan Alex Cacovean MD Thorsten Kirschberg Thomas Butler Ramses Erdtmann Franco Valle Chief of People Chief Technical & Exec. Medical EVP of Chemistry VP of Biology Chairman & CEO President &
COO Chief Financial Quality Officer Director Officer 22 years in Life Science 15 years in Life Science 15 years in Life Science 15 years in Life Science 13 years in Life Science 15 years in Life Science 25 years in Life Science 20 years in Life
Science Pharmacyclics Iovance Inc. Pharmacyclics Pharmacyclics Pharmacyclics Eidos Therapeutics Terns Pharmaceuticals Pharmacyclics Collegium Pharmaceutical Pharmacyclics Genentech Gilead Sciences Oxygen Investments Iovance Biotherapeutics Gilead
Sciences Rigel Pharmaceuticals Praecis Pharmaceuticals PPD Inc. UC Irvine, BA Comm UCLA - MBA Finance Commerzbank Pharmacyclics Cell Gate University of Tokyo, Ohio State University Henry Ford Hospital SF State University, UCSB, MS -
Chemistry University of M nster, CallidusCloud Golden Gate Ph.D. Biology Santa Clara University University of Medicine Comm Master's in Banking & PricewaterhouseCoopers University, MBA Leavey School of Business, and Pharmacy
"Iuliu Corp Finance San Jose State University, University of M nster, MBA - Finance & Hatieganu" Cluj- BS Corporate Finance Ph.D., Chemistry Management Napoca, Romania, M.D. 5
Biomea FUSION System Discovery Platform We leverage our
FUSION System to discover and develop novel irreversible inhibitors against targets essential for cancer Scaffold Scaffold Scaffold 2 3 1 Our FUSION System Discovery Platform encompasses the following: Target selection:
Expertise in structural biology and Asn Gly irreversible binding chemistry. Met Trp Scaffold Scaffold creation: Computational approach to exploit 3 unique structural elements of target proteins and create novel scaffolds. Molecule
optimization: Proprietary suite of computational Computational Chemistry technologies, assays, analytical approaches, chemistry to maximize selectivity, potency, safety and convenience of our oral irreversible small molecule product candidates.
6Biomea FUSION System Discovery Platform We leverage our FUSION System to discover and develop novel irreversible inhibitors against targets essential for cancer Scaffold Scaffold Scaffold 2 3 1 Our FUSION System Discovery
Platform encompasses the following: Target selection: Expertise in structural biology and Asn Gly irreversible binding chemistry. Met Trp Scaffold Scaffold creation: Computational approach to exploit 3 unique structural elements of
target proteins and create novel scaffolds. Molecule optimization: Proprietary suite of computational Computational Chemistry technologies, assays, analytical approaches, chemistry to maximize selectivity, potency, safety and convenience of
our oral irreversible small molecule product candidates. 6
Irreversible Drugs offer several potentially significant Advantages
Greater Therapeutic High Selectivity Deep Target-Inactivation Window Irreversible inhibitors can cause Irreversible drugs are designed to Irreversible drugs leverage both non- permanent inactivation of bound maintain their
effect in the absence covalent and covalent interactions to protein. of sustained drug exposure, unlike drive selectivity. conventional reversible drugs, which typically need to be present to Irreversible binding may result in the
Offers greater potential selectivity provide benefit. target elimination through normal versus reversible compounds, which cellular degradation processes. rely on non-covalent bonding alone. Uncoupling of drug effects from drug exposure can
potentially enable Target inactivation can trigger rapid High selectivity provides potential to lower drug dosing and less frequent apoptosis or differentiation into a reduce non-specific, off-target dosing regimens versus reversible
normal, mature cell. interactions that often lead to safety approaches. and tolerability challenges. 7Irreversible Drugs offer several potentially significant Advantages Greater Therapeutic High Selectivity Deep Target-Inactivation Window
Irreversible inhibitors can cause Irreversible drugs are designed to Irreversible drugs leverage both non- permanent inactivation of bound maintain their effect in the absence covalent and covalent interactions to protein. of
sustained drug exposure, unlike drive selectivity. conventional reversible drugs, which typically need to be present to Irreversible binding may result in the Offers greater potential selectivity provide benefit. target elimination
through normal versus reversible compounds, which cellular degradation processes. rely on non-covalent bonding alone. Uncoupling of drug effects from drug exposure can potentially enable Target inactivation can trigger rapid
High selectivity provides potential to lower drug dosing and less frequent apoptosis or differentiation into a reduce non-specific, off-target dosing regimens versus reversible normal, mature cell. interactions that often lead to safety approaches.
and tolerability challenges. 7
Irreversible Drugs are designed to uncouple Drug-Effects from
Drug-Exposure The chart shows Ibrutinib, an approved, irreversible PK/PD - Current Commercial Drug BTK inhibitor. Irreversible drugs can be designed to achieve nearly complete occupancy in short time, and occupancy is intended
to be sustainable over 24 hours. Irreversible drugs are also designed to be cleared rapidly to minimize off target toxicity. Irreversible binding potentially offers: - Optimal Effect (Pharmacodynamics (PD)) / Exposure
(Pharmacokinetics (PK)) - Maximum Target Engagement - Better Selectivity (Lower Molecular Weight) - Better Drug-Like Properties (Lower Molecular Weight) 8 (ng/ml)Irreversible Drugs are designed to uncouple Drug-Effects from Drug-Exposure The
chart shows Ibrutinib, an approved, irreversible PK/PD - Current Commercial Drug BTK inhibitor. Irreversible drugs can be designed to achieve nearly complete occupancy in short time, and occupancy is intended to be sustainable over 24
hours. Irreversible drugs are also designed to be cleared rapidly to minimize off target toxicity. Irreversible binding potentially offers: - Optimal Effect (Pharmacodynamics (PD)) / Exposure (Pharmacokinetics (PK)) - Maximum Target
Engagement - Better Selectivity (Lower Molecular Weight) - Better Drug-Like Properties (Lower Molecular Weight) 8 (ng/ml)
Biomea Irreversible Drugs have a long History in Medicine Aspirin was
the first irreversible drug, discovered in 1899, and is to date the most used medicine in the world Aspirin Sofosbuvir (Sovaldi) Ibrutinib (Imbruvica) Penicillin Tenofovir (Viread) Osimertinib (Tagrisso) 9Biomea Irreversible Drugs have a long
History in Medicine Aspirin was the first irreversible drug, discovered in 1899, and is to date the most used medicine in the world Aspirin Sofosbuvir (Sovaldi) Ibrutinib (Imbruvica) Penicillin Tenofovir (Viread) Osimertinib (Tagrisso) 9
High Barriers to Entry to develop Irreversible Drugs Complexity Safety
and Toxicity The discovery and development of irreversible drugs has been While the irreversible binding modality can provide a high degree limited by: of selectivity, potential risks have presented barriers: Need for specialized
understanding of proteome structural Irreversible molecules with promiscuous binding profiles can knowledge and medicinal chemistry capabilities, including the pose risk of significant off-target interactions and safety ability to construct
complex novel chemical scaffolds. concerns. Limited knowledge and availability of targets as not all Drug developers, without the experience and specific disease causing proteins have the properties necessary for capabilities
required to develop irreversible binders, have the application of irreversible binding. historically not pursued irreversible drugs. 10High Barriers to Entry to develop Irreversible Drugs Complexity Safety and Toxicity The discovery and development
of irreversible drugs has been While the irreversible binding modality can provide a high degree limited by: of selectivity, potential risks have presented barriers: Need for specialized understanding of proteome structural
Irreversible molecules with promiscuous binding profiles can knowledge and medicinal chemistry capabilities, including the pose risk of significant off-target interactions and safety ability to construct complex novel chemical scaffolds. concerns.
Limited knowledge and availability of targets as not all Drug developers, without the experience and specific disease causing proteins have the properties necessary for capabilities required to develop irreversible binders, have the
application of irreversible binding. historically not pursued irreversible drugs. 10
Biomea's Pipeline of Irreversible Proprietary Assets We are
building a platform of irreversible inhibitors in multiple tumor types KEY IND- DISCOVERY PHASE 1 PHASE 2 PHASE 3 ANTICIPATED ENABLING MILESTONES File IND in the BMF-219 menin dependent second half of Irreversible Menin cancers 2021 Inhibitor
Declare Target: UNDISCLOSED candidate in the first half of Therapeutic Area: 2022 Oncology Target: UNDISCLOSED Therapeutic Area: Oncology 11 DISCOVERY DEVELOPMENT Biomea's Pipeline of Irreversible Proprietary Assets We are building a platform
of irreversible inhibitors in multiple tumor types KEY IND- DISCOVERY PHASE 1 PHASE 2 PHASE 3 ANTICIPATED ENABLING MILESTONES File IND in the BMF-219 menin dependent second half of Irreversible Menin cancers 2021 Inhibitor Declare Target:
UNDISCLOSED candidate in the first half of Therapeutic Area: 2022 Oncology Target: UNDISCLOSED Therapeutic Area: Oncology 11 DISCOVERY DEVELOPMENT
Menin - a Protein important to transcriptional Regulation Menin
impacts major processes such as cell cycle control, apoptosis, and DNA damage repair Liquid Tumor Role Solid Tumor Role Source: Cierpicki & Grambacka, Future Med. Chem. (2014) Modified after Uckelmann (Scott Armstrong Lab) , ASH 2018, Abstract #
Menin-MLL Interaction Schematic of key proteins and their interactions
in the regulation of gene transcription Inhibition of the menin-MLL Transcriptional interaction leads to upregulation reduction in MEN1 Biomea of leukemic drivers: transcription, resulting in HOX genes, MEIS1, down regulation of MEIS1,
EZH2, HOXA9 and DMNT3A, and differentiation of leukemic cells into myeloid cells. BMF-219, is intended to irreversibly inhibit the Biomea interaction between menin and wild type MLL and MLL fusions. Modified after Rao & Dou
(2015). Hijacked in cancer: the KMT2 (MLL) family of methyltransferases. Nat.Rev.Cancer. 15: 334-346 13Menin-MLL Interaction Schematic of key proteins and their interactions in the regulation of gene transcription Inhibition of the menin-MLL
Transcriptional interaction leads to upregulation reduction in MEN1 Biomea of leukemic drivers: transcription, resulting in HOX genes, MEIS1, down regulation of MEIS1, EZH2, HOXA9 and DMNT3A, and differentiation of leukemic cells into myeloid
cells. BMF-219, is intended to irreversibly inhibit the Biomea interaction between menin and wild type MLL and MLL fusions. Modified after Rao & Dou (2015). Hijacked in cancer: the KMT2 (MLL) family of methyltransferases. Nat.Rev.Cancer.
BMF-219 has demonstrated rapid Reduction in Menin dependent Gene
Expression = Target Engagement Molecular responses following MEN1 MEIS1 HOXA9 DNMT3A * TPM treatment with BMF-219 in 8 0.8 80 0.20 MOLM-13 cells (an acute myeloid leukemia cell line with a 6 0.6 60 0.15 KMT2A-MLLT3 fusion). 6h 4 0.4 40 0.10