7. Breast Cancer Vaccine Program
13. Ovarian Cancer Vaccine Program
16. Ovarian Cancer CAR - T Program
23. COVID - 19 Therapy Program
1. NASDAQ:ANIX X November 2021 Amit Kumar, PhD Chairman and CEO ak@anixa.com
2. NASDAQ: ANIX 2 Forward - Looking Statements Statements that are not historical fact may be considered forward -looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Forward -looking statements are not statements of historical facts, but rather reflect Anixa Biosciences’ current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely, ” “will” and similar expressions to identify forward -looking statements. Such forward -looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward -looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our most recent Annual Report on Form 10 -K as well as in our Quarterly Reports on Form 10 -Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward -looking statements, whether as a result of new information, future events or otherwise, except as required by law . You are cautioned not to unduly rely on such forward -looking statements when evaluating the information presented herein .
19. NASDAQ: ANIX 19 Only in Fetal Thymus *In Healthy Humans* FSHR ONLY Expressed in Ovaries and Testes Source: Perales-Puchalt et al. “Follicle-stimulating ho rmone receptor is expressed by most ovarian cancers subtypes and is a safe and effective immunotherapeutic target.” Clin ical Cancer Research. 2017. FSHR expressed on the blood vessels of many TUMORS This therapy will be anti- angiogenic for many types of cancer, enabling a portfolio of therapies for multiple cancers
11. NASDAQ: ANIX 11 NASDAQ: ANIX Breast Cancer Vaccine Trial: Conducted by Cleveland Cli nic An o pen -label, Phase I dose-escalation trial in which successive cohor ts of participants with high-risk triple- negative breast cancer will be treated with successively highe r doses of α-lactalbumin and zymosan 18 -24 patients who have completed treatment for early-sta ge, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurre nce To determine the maximum tolerated dose (MTD), dose- limiting toxicity (DLT) incidence and lowest i mmunologi c dose (LID) of the vaccine in patients with early- stage, triple-negative breast cancer as well as monitor immune response. Participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed in the third quarter of 2022. Objective Design Data Readout
26. NASDAQ: ANIX 26 NASDAQ: ANIX Seasoned Management Team Amit Kumar, Ph.D. Chairman, President and CEO Michael Catelani Chief Operating Officer and Chief Financial Officer Pamela D. Garzone , Ph.D. Chief Development Officer
9. NASDAQ: ANIX 9 Robust Pre - Clinical Response Well - Tolerated 100% of α- LACTALBUMIN vaccinated mice did not develop breast cancer 80% of un -vaccinated mice developed breast cancer Vaccinated mice did not exhibit autoimmune damage, while single T-cell infiltrates were seen in non-lactating breast tissue (arrows) Pre - Clinical Studies: Vaccination Prevents Breast Cancer Data published: Cancers , 2016, 8 , 56.
21. NASDAQ: ANIX 21 Our FSHR - Mediated CAR - T Program: The First Potential Anti - Angiogenic CAR - T Therapy Exclusive worldwide license from The Wistar Institute We Believe Our CER - T Approach Will Work In Solid Tumors, Especially Ovarian Cancer, Where Others Have Failed 1. FSHR is a unique target 2. FSH is a natural ligand (not synthetic) 3. Our approach may provide anti-angiogenic synergy 4. Our CAR -T will execute a dual mechanism of action in destroying the tumor Previous Challenges: • The CAR -T cells may not be susceptible to the highly suppressive tumor microenvironment (TME) • As the CAR-T cells are destroying vasculature, they make it leakier, enabling simultaneous, localized delivery of other agents including chemotherapy • CAR -T mediated cell death may be more powerful than other anti -angiogenesis drugs
3. NASDAQ: ANIX 3 NASDAQ: ANIX Anixa Biosciences: At -a- Glance Anixa Biosciences is a clinical-stage company collaborating with world-renowned research Institutions to develop first- in -class treatments to prevent and treat unmet needs in oncology and infectious diseases Overview NASDAQ: ANIX • Biotech Bay Area, CA Strong Balance Sheet • >$35MM Cash, No debt Capital Efficient • Market Cap = $150M
14. NASDAQ: ANIX 14 Ovarian Cancer Vaccine: Retired Tissue Specific Protein Retired Tissue Specific Protein • Expressed at periods of life, but no longer expressed as we age Inventor and PI: Vincent K. Tuohy, Ph.D. Mort and Iris November Distinguished Chair in Innovative Cancer Research, C leveland Clinic • The Extracellular Domain of the Anti- Mullerian Hormone Receptor 2 (ED-AMHR2) is primarily expressed in the ovaries but disappears as a woman reaches an d advances through menopause • The majority of ovarian cancer diagnoses occur after menopa use • AMHR2 is expressed again in the majority of ovarian cancers as well as some other gynecological malignancies • If we properly immunize a woman against this protein, a fter she has reached menopause, we should be able to prevent the occurrence of ovarian cancer
20. NASDAQ: ANIX 20 Our FSHR - Mediated CAR - T Technology • Many tumors have blood vessels where FSHR is expressed even though healthy tissue does not show such expression o Physiologically, FSHR may be helpful in enabling tumors to create vasculature o Elegant target: outside of the tumor margin, FSHR o n blood vessels disappears • Anti -angiogenesis drugs are a multi- billion -dollar class of drugs, with Avastin the leader with 2017 sales of $7BB These blood vessels are positive for FSHR Tumors expressing FSHR on vasculature: Lung, Breast, Prostate, Colon, Head & Neck, Pancreatic, Liver, Renal, Ovarian and others Angiogenesis Tumors induce rapid blood vessel growth to nourish themselves Formation of new tumor vasculature Our FSHR targeted CAR -T may destroy tumor vasculature and starve or shrink the tumor
15. NASDAQ: ANIX 15 NASDAQ: ANIX Profile: Ovarian Cancer Vaccine Key Attributes Cleveland Clinic collaboration NCI funding support via its peer -reviewed PREVENT development program PREVENT is supporting pre-clinical innovative interventions and biomarkers for cancer prevention and interception Pre -IND work is being conducted at the NCI under the PREVENT Program Pre -clinical data published ( Cancer Prev. Res. 2017, 10(11); 612 - 624) A significant market opportunity: Eligible candidates for the ovarian cancer vaccine will be similar to the breast cancer patient population only slightly older in age. Though a less common cancer, it’s one of the most aggressive reproductive cancers and the prognosis is dire.
18. NASDAQ: ANIX 18 NASDAQ: ANIX Cancerous B-cell T- Cell engineered to recognize and kill cells with CD - 19 protein on surface CD19 protein (antigen) scFv-antibody fragment engineered into T -cell Ovarian Cell FSHR protein (“Antigen”) - found only on ovarian cells FSH Follicle Stimulating Hormone T- Cell engineered with FSH to recognize and kill cells with FSHR protein on surface Chimeric Endocrine Receptor T - Cell Anixa’s Unique CER - T Approach for Solid Tumors Anixa’s CAR - T Program for Ovarian Cancer Follicle Stimulating Hormone Receptor (FSHR)- mediated CAR -T Technology Other CAR - T Programs: Novartis, JUNO, KITE and others working on B-Cell cancers
10. NASDAQ: ANIX 10 NASDAQ: ANIX Breast Cancer Vaccine Clinical Trial Plan Completed Commenced • GLP Tox • IND Filed and Cleared by the US FDA • TNBC patients who have undergone standard of care • Will monitor pro -inflammatory antibody and T-cell response • Healthy women with BRCA1 mutations • Decided to undergo prophylactic mastectomy • Will immunize before surgery and monitor antibody and T-cell response and resected tissue Funded by Department of Defense (DOD) Grant $6.2 MM Pre - Clinical Studies Phase 1a Trial Phase 1b Trial
5. NASDAQ: ANIX 5 Investment Highlights • Unique, Capital Light Business Model Relies on Partneri ng of All Laboratory Operations with World - Class Research Centers/Iconic Academic Institutions o Technology exclusively in-licensed; programs developed by Moffi tt and Cleveland Clinic o No build -out of immense fixed costs; modest rate of funding each p rogram due to offset • Leading Therapeutic and Vaccine Candidates Have the Potential to Change the Treatment Landscape in High - Value Categories (Breast and Ovarian Cancer) o FDA has cleared two INDs with one trial having commenced and the other initiating near year- end • Strong Cash Position With No Debt o 6-year cash runway o Approximately $5M annual burn since 2017 • Clinical Programs Represent Multi - Billion - Dollar Opportunities o Leveraged for partnering and monetizing products for sha reholders
17. NASDAQ: ANIX 17 CAR - T Technology: Background and Opportunity CAR - Technology has made great inroads in B - Cell cancers • Durable responses (50-80% of patients) • Multibillion dollar valuations and big pharma deals o Novartis - First approved product by FDA • Kymriah for ALL- Acute Lymphoblastic Leukemia • Second approval for DLBCL-Diffuse large B- cell Lymphoma o KITE - $12BB acquisition by GILD o JUNO - $9BB acquisition by CELG Our Opportunity • Conventional CAR-T has not worked clinically in solid tumors Unique Approach à Anixa has a novel technology for making CAR - T work in multiple solid tumors, beginning with Ovarian Cancer
12. NASDAQ: ANIX 12 NASDAQ: ANIX Breast Cancer Vaccine: A Significant Market Opportuni ty o More than 80 million women are currently 40 or older in the U.S. alone • Millions more age into this group annually 1 Breastcancer.org U.S. (Total Eligible Population) Outside U.S. (Billions of Candidates) Breast cancer became the most common cancer globally as of 2021, accounting for 12% of all new annual cancer cases worldwide, according to the World Health Organization 1 • Prophylactic (preventative) vaccines are administered to the total eligible population • We expect reimbursement for this vaccine to be similar to t he cervical cancer vaccine (~$400 retail cost) o Approximately 1.4 billion women are 40 and older outside the U.S.
4. NASDAQ: ANIX 4 NASDAQ: ANIX Strategy: Low-Cost Business Model Key Collaborators Unique Business Model: Overview • Invent/in-license technology platforms o Develop technology and programs with partners § Leverage existing infrastructure of partner § Maintain low overhead and cash burn § Allows for multiple orthogonal projects o Out -license programs to pharma for late -stage clinical development and commercialization Mo l Geni e
22. NASDAQ: ANIX 22 Summary: Our FSHR - Mediated CAR - T Program • Pre -clinical testing o Tested human CAR-T in immunocompromised mice against hum an ovarian cancer o Tested murine CAR-T in immunocompetent mice against mur ine ovarian cancer o Tested human CAR-T in immunocompromised mice against hum an breast cancer (proof- of - concept) • Pre -IND work at Moffitt Cancer Center led by highly experie nced team • IND Cleared in August 2021 • Ovarian Cancer Clinical Trial o Single site, open label, dose-escalation trial • Lead by Moffitt Cancer Center • Safety focused trial with window to efficacy o Clinical trial to commence Q4 ‘21 Data published: Clinical Cancer Research , 23(2)January 15, 2017, 441- 453
8. NASDAQ: ANIX 8 NASDAQ: ANIX Retired Tissue Specific Protein • Expressed at periods of life, but no longer expressed as we age Breast Cancer Vaccine: Retired Tissue Specific Protein Inventor and PI: Vincent K. Tuohy, Ph.D. Mort and Iris November Distinguished Chair in Innovative Cancer Research, Cleveland Clini c α- LACTALBUMIN • Expressed only in the breast and only during lactation • Expressed in tumor cells, especially Triple Negative Breast Cancer ( TNBC ) • Our vaccine targets this retired protein – Once vaccinated, the patient’s immune system is ready to destroy cells expressing the protein as they arise, disallowing cancer to gain critical mass Triple Negative Breast Cancer (TNBC) • Most aggressive form of breast cancer • Prevalent cancer in patients with breast cancer gene (BRCA ) mutations
25. NASDAQ: ANIX 25 NASDAQ: ANIX Value - Creating Near - Term Milestones CAR - T Program • Initiation of Clinical Trial • Patient recruitment • First patient dosed • Clinical Data Release • Initiate pre -clinical work on other tumors – Anti -angiogenesis Breast Cancer Vaccine • Phase 1a trial Fully Enrolled • First patient Dosed in Phase 1b • Clinical Data Release Ovarian Cancer Vaccine • R&D Data release and publications • Initiate IND -enabling studies • File IND Application Covid - 19 Therapeutics • Selection of clinical candidate • Initiate IND -enabling studies • Seek Government Research Funding • Strategic alliances • File IND Application Near - Term Shareholder Goals • Raise visibility, market capitalization and liquidity • Diversify investor base • Maintain conservative cash position
6. NASDAQ: ANIX 6 NASDAQ: ANIX CAR - T: C a n c e r Immunotherapy Program • Chimeric Endocrine Receptor T- Cell (CER - T): A new type of CAR-T • First indication - ovarian cancer (platform for multiple cancer indications) • Worldwide license Covid - 19 Therapeutic • Targeting main protease ( Mpro) of SARS - CoV -2 • Shelf -stable, orally administered pill • Animal POC studies show comparability to Remdesivir • Performing combinatorial medicinal chemistry to optimize pharmacokinetics and increase potency Breast Cancer Vaccine • Immunize against α-Lactalbumin to prevent Triple Negative Breast Cancer (TNBC) and other breast cancers • Worldwide license • Cleveland Clinic collaboration for IND and clinical tria ls • $6.2 MM DOD grant to fund pre -clinical work and two Phase 1 clinical trials Ovarian Cancer Vaccine • Immunize against the Extracellular Domain of the Anti -Mullerian Hormone Receptor 2 to prevent Epithelial Ovarian Cancer and other gynecological cancers • Worldwide license • Cleveland Clinic collaboration for IND and clinical tria ls • Pre -Clinical work in progress • NCI -PREVENT Program supporting pre-clinical development through IND submission Four High Value Programs in Oncology and Infectious Disease Mo l Geni e Moffitt Cancer Center Collaboration for IND and clinical trial (IND cleared, August 2021) Phase 1 trial has commenced
24. NASDAQ: ANIX 24 Covid - 19 Therapy Program • Initiated April 20, 2020 with partner MolGenie , GmbH o Virtual Screening (1.2 BB compounds) o Targets: Main Protease ( Mpro), Endoribonuclease (NSP - 15) • In Silico Hits o Utilize Molecular Modeling, Screening algorithms o “Hits” will be synthesized and tested in vitro o Candidate Drugs will be tested in animal models • Pre -IND Testing • Clinical Trials Goals ☐ Inexpensive, orally-administered pill, outpatient settin g ☐ Perform combinatorial medicinal chemistry around best compound from animal POC study to increase potency and optimize pharmacokinetics ☐ Commence Pre-IND studies Hit Candidates will be synthesized and tested in in vitro assays Animal Studies in silico Studies • Molecular Modeling • Machine Learning • H. P. Computing 2- D and 3 -D Binding Prediction Pharmacokinetics (ADME) Toxicity Other Drug - Like Properties Virtual Screening & Scoring 1.2 Billion Compounds SARS - CoV - 2 Enzymes Current Status ü Completed Initial Screening ü Identified several Hit compounds ü Identified compounds with comparable potency to Remdesivir ü Completed proof - of -concept animal studies
