CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (January 2019)
23 slides from CytoDyn's investor presentation, Jan 10, 2019
Slide 1: Leronlimab (PRO 140) HIV - Cancer Investor Presentation
Exhibit 99.2 Leronlimab (PRO 140) ® ® HIV - Cancer INVESTOR PRESENTATION January 2019 Professor Richard G. Pestell M.D., Ph.D., MB., B.S., F.A.C.P., F.R.A.C.P., F.A.A.A.S., M.B.A. Vice Chairman and Chief Medical Officer Nader Pourhassan Ph.D., President & CEO OTCQB: CYDY www.cytodyn.comExhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding leronlimab’s efficacy in certain cancer indications, the predictive value or benefit from the Compa
Slide 3: Recent Developments
Recent Developments • CD02 Phase 3, Pivotal trial - Combination Therapy • Achieved primary endpoint (p=0.0032) – 81% response rate – BLA in 1Q2019 • CD03 Phase 3 HIV investigative trial - 360+ enrolled (60 patients one year) • About 70% response rate at 525 mg - About 90% response rate at 700 mg • P
Slide 4: Leronlimab (PRO 140) – A Humanized Monoclonal Antibody Blocking CCR5
Leronlimab (PRO 140) – A Humanized Monoclonal Antibody Blocking HIV entry receptor (CCR5) Blocking CCR5/CCL5 interaction with leronlimab for use in CANCER Humanized monoclonal Binds to CCR5 co-receptor on antibody white blood cells HIV CD4 Leronlimab CCR5 Blocks HIV entry into white HAART blood cell
Slide 5: Leronlimab vs. HAART comparison; FDA fast track designation
FDA: “fast track designation” – “accelerated approval” NIH: $28 million grants BECAUSE Leronlimab HAART (PRO 140) No serious side effects and Ranges from mild to severe Side Effects no serious adverse events (SAEs) (Diarrhea, nausea, lethargy, in >670 patients in 8 clinical trials depression) Toxici
Slide 6: CD02 Pivotal Combination Trial
CD02 Pivotal Combination Trial with leronlimab (PRO 140) • 52 patients prescreened for R5 strain and failing current HAART regimen (3 class resistance or 2 class resistance with limited treatment options) • Primary efficacy endpoint: reduction in viral load after 1 week following single PRO 140 dose
Slide 7: Potential Approval in HIV
Potential Approval for leronlimab (PRO 140) in HIV • Timeline for submitting rolling BLA • Non-Clinical - Completed • Clinical - 1Q19 • CMC (Manufacturing) - 1Q19 • Final Complete package: 1Q19 www.cytodyn.com 7 7Potential Approval for leronlimab (PRO 140) in HIV • Timeline for submitting rolling BL
Slide 8: CD03 Investigative Monotherapy Trial
CD03 leronlimab (PRO 140) Investigative Monotherapy Trial • All patients prescreened for R5 strain with viral load suppression maintained with HAART • Ongoing open-label, 48-week trial with all patients receiving PRO 140 weekly injections • Investigative trial with focus on increasing responder rate
Slide 9: U.S. Market Size for HIV Indication
U.S. Market Size for HIV Indication for leronlimab (PRO 140) Patients using Year HIV patients 1 resistance 2 resistance 3 resistance HAART 2017 1,373,636 712,532 645,646 218,248 28,372 2018 1,400,406 745,167 671,257 232,291 27,875 2019 1,421,563 775,245 694,404 246,842 27,153 2020 1,432,683 799,418
Slide 10: U.S. Market Potential in HIV
U.S. Market Potential for leronlimab (PRO 140) in HIV Alone Initial approval Combination Therapy • HAART failures: ~ 70,000* patients with 2 or more drug class resistances • 70,000 patients x 70% (R5-HIV strain) = 49,000 HIV patient R5 eligible • 49,000 patients x $24,000 (current market pricing) =
Slide 11: U.S. Market Size - Research Report From BIOVID
U.S. Market Size - Research Report From BIOVID E Ex xe ec cu ut ti iv ve e S Su um mm ma ar ry y However, patients show a strong leronlimab (PRO 140) call to action • Monotherapy patients are slightly more likely to act Patient Reactions to PRO 140 (pre-video review) Monotherapy Patients Combo Thera
Slide 12: Leronlimab Immunologic Indications
Leronlimab (PRO 140) Immunologic Indications Additional potential leronlimab (PRO 140) applications • GvHD • Cancer including tumor metastasis (Dr. Richard Pestell) www.cytodyn.com 1 12 2Leronlimab (PRO 140) Immunologic Indications Additional potential leronlimab (PRO 140) applications • GvHD • Canc
Slide 13: Effect on Xeno-GvHD Human BM Transplanted Into Immuno-Deficient Mice
Effect of leronlimab (PRO 140) on Xeno-GvHD Human BM Transplanted Into Immuno-Deficient Mice 100 24.0 23.5 80 Control Control 23.0 60 PRO 140 PRO 140 22.5 40 22.0 P < .01 P < .01 20 21.5 21.0 0 0 10 20 30 40 50 60 0 20 40 60 80 100 Day Day 13 www.cytodyn.com 1 13 3 Weight gm mean ± SE Survival %Effe
Slide 14: Expansion into Cancer Indications
Expansion into Cancer Indications • Named world-renowned oncologist Dr. Richard Pestell Chief Medical Officer and Vice Chairman • Lead leronlimab (PRO 140) non-HIV development programs • Led 2 National Cancer Institute-designated cancer centers • Lombardi Comprehensive Cancer Center at Georgetown Un
Slide 15: CCR5 is Expressed in >50% of Breast Cancer
CCR5 is Expressed in >50% of Breast Cancer – Metastatic cancer. Ø 50% of breast cancers CCR5+ Ø Leronlimab(PRO 140) reduces breast cancer invasion P<0.001 P<0.001 1000 800 600 400 200 0 Leronlimab Control PRO140 (1/500) Vicriviroc Professor Richard Pestell, PhD, MD www.cytodyn.com 1 15 5 Distance of
Slide 16: Leronlimab Blocks Breast Cancer Ca signaling
+2 Leronlimab (PRO 140) Blocks Breast Cancer Ca signaling A 20 sec before 60 sec after 240 sec after 60 sec after adding CCL5 adding CCL5 adding CCL5 adding FBS B C FBS 3 3 FBS CCL5 CCL5 2 2 1 1 0 0 Control PRO140 -1 -1 0 200 400 600 800 1000 0 200 400 600 800 1000 Time (Sec) Time (Sec) Professor Ri
Slide 17: CCR5 Antagonists Block Breast Cancer Metastasis
CCR5 Antagonists Block Breast Cancer Metastasis Time (weeks) 1 2 3 4 15.0 12.5 10.0 7.5 5.0 * 2.5 0 0 1 2 3 4 5 Time (weeks) Professor Richard Pestell, PhD, MD www.cytodyn.com 1 17 7 Control MaravirocCCR5 Antagonists Block Breast Cancer Metastasis Time (weeks) 1 2 3 4 15.0 12.5 10.0 7.5 5.0 * 2.5 0
Slide 18: CCR5 Antagonists Block Prostate Cancer Metastasis
Professor Richard G. Pestell CCR5 Antagonists Block Prostate Cancer Metastasis Professor Richard Pestell, PhD, MD www.cytodyn.com 1 18 8 Control MaravirocProfessor Richard G. Pestell CCR5 Antagonists Block Prostate Cancer Metastasis Professor Richard Pestell, PhD, MD www.cytodyn.com 1 18 8 Control M
Slide 19: Objective Tumor Response, Phase 1 Trial
Objective Tumor Response, Phase 1 Trial advanced-stage metastatic colorectal cancer who are refractory to standard chemotherapy, including regorafenib Partial Response (RECIST) Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer
Slide 20: Leronlimab Breast Cancer Study
Leronlimab (PRO 140) Breast Cancer Study PRO 140 525mg 1sc/week Carboplatin AUC 2q week x3 28 days cycle Endpoints 1. OS 2. PFS’ 3. Decreased CTC Breakthrough (unmet need) November 2018-March 2019 April 2019-July 2021 (Phase III) Phase II 2 22 2 TNBC Rx Refractory CCR5+ CTCLeronlimab (PRO 140) Breas
Slide 21: Potential Market Size for CCR5 Antagonist for Breast Cancer
Potential Market Size for CCR5 Antagonist for Breast Cancer Trastuzumab for breast cancer with HER-2+ patients Annual sales = $15 billion HER-2+ is about 12% of breast cancer population CCR5 + is about 50% breast cancer population Market potential ~ 4 x $15 billion = $60 billion Daniel Lindner, M.D.
Slide 22: Other Potential Non-Dilutive Capital Raise
Other Potential Non-Dilutive Capital Raise Ø Prognostic Test Potential licensing in 2019 Ø Potential use of leronlimab • Already sent product to interested EU collaborators • Already testing for CCR5 staining purposes Ø Several abstracts • At least 5 abstract are ready or will be submitted for publi
Slide 23: Important Milestones for HIV and Cancer 2019
PRO 140 Important Milestones for HIV and Cancer 2019 Milestones Target Dates BLA submission 1H2019 Revenue potential of about $480 million 2020 Large Pharma discussion for potential licensing or partnering 1H2019 Triple Negative Breast Cancer study first patient injected 1Q2019 Triple Negative Breas