Slide 1: REVTORPYK (gedatolisib) FDA Approval
: celcuity g@ REVTORPYK’ % gedatolisib te meion FDA Approval July 14, 2026
Slide 2: Forward-Looking Statements
_ Forward-Looking Statements This presentation contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing o
Slide 3: Agenda
Agenda Intro and Overview Brian Sullivan Chief Executive Officer and Co-Founder REVTORPYK Data & Label Igor Gorbatchevsky, MD Chief Medical Officer REVTORPYK: Commercial Overview Eldon Mayer Chief Commercial Officer Upcoming Milestones Brian Sullivan
Slide 4: Intro and Overview
Intro and Overview Brian Sullivan Chief Executive Officer and Co-Founder
Slide 5: REVTORPYK Is Now FDA-Approved
_REVTORPYK Is Now FDA-Approved REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for 4 Tl 5 the treatment of HR+/HER2- locally advanced or metastatic rene creer witeus % ged At isio so Pe fen PIK3CA mutation detected following progression on or after 2 1 line of en
Slide 6: REVTORPYK is well positioned for near- and long-term success
REVTORPYK is well positioned for near- and long-term success, with a $10B+ » U.S. market potential across the 1L and 2L+ HR+/HER2- ABC settings LARGEST TWO POSITIVE UNTAPPED DRUG PHASE 3 DEVELOPMENT BEST-IN-CLASS, FIRST-IN-CLASS PAM INHIBITOR READOUTS IN 2L OPPORTUNITY SETTING IN BREAST CANCER Inhib
Slide 7: REVTORPYK Label & Supporting Data
REVTORPYK Label & Supporting Data Igor Gorbatchevsky, MD Chief Medical Officer
Slide 8: Overview of REVTORPYK U.S. Prescribing Information
Overview of REVTORPYK U.S. Prescribing Information INDICATION: =» REVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with HR+/HER2- locally advanced or metastatic breast cancer without a P/IK3CA mutation detected following progres
Slide 9: Co-Primary Endpoint: PFS of REVTORPYK Triplet vs. Fulvestrant
‘ Co-Primary Endpoint: PFS of REVTORPYK Triplet vs. Fulvestrant 7.3 months improvement in mPFS >4.5x mPFS with REVTORPYK triplet vs fulvestrant alone Geda + Palbo + fulvestrant (n=131) = % = 70. Median PFS, 9.3 2.0 g months (95% Cl) (7.2-16.6) (1.8-2.3) 3 : Adjusted HR (95% Cl) Wes = 2 J ° (0.17-0.3
Slide 10: Co-Primary Endpoint: PFS of REVTORPYK Doublet vs. Fulvestrant
‘ Co-Primary Endpoint: PFS of REVTORPYK Doublet vs. Fulvestrant 5.4 months improvement in mPFS >3.5x mPFS with REVTORPYK triplet vs fulvestrant alone Progression-free Survival (%) a 8 i 404 304 20-4 104 04 TrtT?tT?Tit1itttrtrtrtrrt+t+tr+trttitititi 01234 5 6 7 8 9 1011 12 13 14 15 16 17 18 19 20 21
Slide 11: Safety Highlights from REVTORPYK Prescribing Information
Safety Highlights from REVTORPYK Prescribing Information SAFETY SUMMARY " Over 80% of adverse reactions were grade 1 or 2 = No dose reductions or discontinuations of REVTORPYK due to hyperglycemia = Stomatitis was generally manageable, occurred early and reduced in treatment frequency and severity w
Slide 12: REVTORPYK Commercial Overview
. ‘celcuity REVTORPYK™ Commercial Overview Eldon Mayer Chief Commercial Officer
Slide 13: Positioning REVTORPYK for strong market adoption in the 2L+
Positioning REVTORPYK for strong market adoption in the 2L+ HR+/HER2-/PIK3CA Wild-Type & Mutant advanced breast cancer setting ati A ili 0 LARGE SIGNIFICANT UNMET WELL COMPELLING VALUE POPULATION NEED IN HR+/HER2- DIFFERENTIATED PROPOSITION 37,000 patients with ADVANCED BREAST Gedatolisib MOA, Best-
Slide 14: Fragmented market with no "Go To" option for PIK3CA Wild-Type
Fragmented market with no “Go To” option for PIK3CA Wild-Type HR+HER2- ABC patients after progressing on initial endocrine therapy Current Treatments Used in 2L PIK3CA Wild-Type ABC Other “ Other Chemo-Based Regimen CDK4/6i + ET Xeloda (capecitabine) . Endocrine Mono HER2 ADC mTORC1 Oral SERD Source
Slide 15: Entering Launch with Market and Organizational Momentum
Entering Launch with Market and Organizational Momentum sis Ke tii a &] ia ain < it cmh ENGAGED KEY PAM PATHWAY & LAUNCH PLAN EXPERIENCED & STAKEHOLDERS REVTORPYK TACTICS IN PLACE TRAINED TEAMS | AWARENESS/ DEPLOYED & READY & FISH ISGIS CCeniAAIy ADVOCACY + Promotional Materials & TO DELIVER Breast
Slide 16: Access for REVTORPYK is Designed to Offer Patients and Providers
Access for REVTORPYK is Designed to Offer Patients and Providers Rapid Access with Seamless Support Solutions Comprehensive & Simple Patient Support 0 of top Payer Pathways 100 % were engaged pre-approval 4 00% of top 36 Strategic Accounts 0 were engaged pre-approval of US medical benefit lives >909
Slide 17: REVTORPYK Launch Priorities
- REVTORPYK Launch Priorities &@ Oo Al DRIVE AWARENESS RAPID ADOPTION DELIVER ACCESS Rapid engagement of core Unique MOA, Strong Efficacy, Broad payer coverage and REVTORPYK customers Tolerable AE profile world-class patient services 9,000+ 88 1 Academic and Community HCPs Oncology Sales Specialists
Slide 18: REVTORPYK FDA approval lays foundation for multiple potential blockbuster indications
' REVTORPYK FDA approval lays foundation for multiple potential blockbuster -. indications 1L and 2L+ setting for HR+/HER2- advanced breast cancer cS BB 82 25 i Indication 2L +ABC Post-ET 1LABC ET Sensitive 1L ABC ET Resistant (Ph 3 trial) (VIKTORIA-1) (VIKTORIA-2) (VIKTORIA-2) Daratien'ek ~10 month
Slide 19: Upcoming Milestones
Upcoming Milestones Brian Sullivan Chief Executive Officer and Co-Founder
Slide 20: Key Milestones Achieved and Upcoming in 2026-2027
Key Milestones Achieved and Upcoming in 2026-2027 VIKTORIA-1 MT data presented at ASCO VIKTORIA-1 WT data published in JCO NCCN Guidelines submission VIKTORIA-1 MT data sNDA submission NCCN FDA GUIDELINES Present additional VIKTORIA-1 mutant and wild-type data at upcoming medical conferences Update
Slide 21: Unlocking the Potential of Treating Cancers Involving the PI3K/AKT/mTOR Pathway
Unlocking the Potential of Treating Cancers That Involve the PISK/AKT/mTOR Pathway
Slide 22: Thank You
celcuity Thank You ... to the numerous patients and their families who participated in our clinical development program. ... to the clinical investigators, nurses, site coordinators, and countless support staff. ... to the Celcuity team continuously working to deliver this important medicine to pati