Aim Immunotech Inc. · AMEX:AIM
Aim Immunotech — Investor Presentation (July 2023)
30 slides from Aim Immunotech's investor presentation, Jul 10, 2023
Slide 1: Long COVID Presentation Q3 2023
NYSE American: AIM aimimmuno.com S AIM ImmunoTech Long COVID Presentation ris Q3 2023
Slide 2: Forward Looking Statements
Forward Looking Statements Some of the statements included in this presentation may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private
Slide 3: CDC Statistics on Post-COVID Conditions
CDC Statistics on Post-COVID Conditions” For all U.S. adults, the data show: 3 (SAI c/w si aoe /nhaforssoordf ete ese a092) 20 Deen ee 02 Overall, 1 in 13 adults in the U.S. (7.5%) have “long COVID” symptoms, defined as symptoms lasting three or more months after first contracting the virus, and tha
Slide 4: Economic Impact of Long COVID
Economic Impact of Long COVID The U.S. government estimated in late 2022 that long COVID was keeping roughly 1 million people out of the workforce at any given time — costing about $50 billion a year in lost salaries.* Before the pandemic, 1.5 million Americans had ME/CFS, costing $36 billion to $51
Slide 5: Long COVID Market Potential
Long COVID Market Potential The medical costs for treating long In an October 2020 analysis, JAMA While the PCC market cap is hard to COVID have not been estimated, estimated the then-nascent COVID- estimate, according to InsightAce but costs have been estimated for 19 pandemic might result in $2.6
Slide 6: Proposed Mechanisms of Post-COVID Conditions
Proposed Mechanisms of Post-COVID Conditions Immune dysregulation, Persistent he BI Vial replication {Reactivation Immune dysregul (or without reac underlying pathogens, including herpesviruses such as EBV and HHV-6 Impacts of SARS-CoV-2 on the microbiota and virome (including SARS-Cov-2 persistence
Slide 7: Ampligen's Broadly Applicable Antiviral Activity
Ampligen®’s Broadly Applicable Antiviral Activity Ta Sonoma VE Vins Genome Double-stranded ONA Single Svandea ( RNA fh. Hee Silex Tpe2 Ereoraineramaten a7 fe trea in He ETE MTEC TELE TITIES 7 Tapes Sex Type RCT a |e tence, aren avo HSN cied WOOK eal nwo atecion [7a Hepes Sine Type Mouse, nv Preecton
Slide 8: Ampligen as a Potential Treatment of SARS-CoV-2
Ampligen as a Potential Treatment of SARS-CoV-2 Potentially broad-spectrum immune system response against SARS-CoV-2 (COVID-19) Uniquely targets TLR3 without activation of the inflammatory cytosolic helicases Based upon Ampligen’s mechanism of action, it has the potential to be efficacious against a
Slide 9: The Immunological Activity of Ampligen Demonstrated in Literature
The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature Immunological Activity Only TLR3 agonist to promote selective attraction of CTLs (Teff) with concomitant reduction in Treg attraction in the TME Increases Natural Killer (NK) cell activity Phase |/II colorectal
Slide 10: The Immunological Activity of Ampligen (continued)
Qaim The Immunological Activity of Ampligen has been Demonstrated in a Wide Body of Literature - conra Immunological Activity Promotes optimal dendritic cell maturation and Thi-type responses of healthy donors and cancer patients Induces epitope spreading and cross-protective immunity in mice Increa
Slide 11: Ampligen Induces Dendritic Cell Maturation and Enhances T-cell Activation
Ampligen Induces Dendritic Cell Maturation and Enhances T-cell Activation Increased IL-12, HLA Class 1 and II, CD83, CD86, CD40, CCR7 n Qaim Isotype 1L-12p70pgimt |S 2 Poly(tGy,U) wail ™ Untreated Poly IC 1 Pol(IC;2U) cee Human monocyte-derived DC generated from a heathy donor were treated with poly
Slide 12: Ampligen Induces Dendritic Cell Maturation and Enhances T-cell Activation
Enhances T-cell Activation Ampligen Induces Dendritic Cell Maturation and OO TNF@/IEN« 1m PolylC,,U ili WS LAD 12 (p70) IFNy —MCPAMIP-to TNFa Above: Supernatants from dendritic cell cultures that were matured with polyl:C,,U (25 tug/mL) or TNF-a/IFN-a were assayed for a panel of cytokines by Multipl
Slide 13: Ampligen Increases NK and Mo Activity
Ampligen Increases NK and Mo Activity NK Activity Mo Antitumor Activity 7 + . * * 70 * 5 2 50 a g& oy a 40 < ri = 3 @ $30 3 S20 x 10 ° ° 1 2 4 8 ° 1 2 4 8 ‘Ampligen (mg/kg) Ampligen (mg/kg) Dose - response effect of Ampligen on splenic NK activity and peritoneal Mo antitumor activity.* p < 0.05 ttf
Slide 14: Post-COVID Symptoms Share Similarities to ME/CFS
Post-COVID Symptoms Share Similarities to ME/CFS Understanding ME/CES and Long COVID as ME/CFS and Long COVID share similar symptoms and Post-Viral Conditions biological abnormalities: road map to the literature By Susan Carr, Senior Writer Antony Kona ad (f°) W an iit ClinicalTrials,gov > Reumatol
Slide 15: Viral Link to ME/CFS
Viral Link to ME/CFS CFS usually begins with the infection by microorganisms or an immunological disorder [1] Viral studies showed increased prevalence of 2 herpesviruses (HHV-6 and Epstein-Barr virus) in the CFS subjects compared to healthy subjects [2-4] IgM antibodies to human herpesvirus 6 early
Slide 16: Ampligen Clinical Efficacy in ME/CFS
Ampligen Clinical Efficacy in ME/CFS Improvement from mean baseline exercise treadmill duration Baseline, sec 576 588 : Atleast 25%, n(%) 39(39) 25(23) 0.016 At least 50%, (%) 26(26) 15(14) 0.0360 The proportions of subjects in the ITT population with changes from mean baseline Exercise Tolerance Tr
Slide 17: Ampligen Clinical Efficacy in ME/CFS
Ampligen Clinical Efficacy in ME/CFS ME/CFS Patients Treated 2x Weekly with 400 mg L.V. Infusion of Ampligen Showed Statistically Significant Improvements in Cognition (SCL-90-R) Over Placebo Summary of Means and Mean Changes in Symptoms Checklist 90 Revised Cognitive Deficit (SCL-90-R CD) Subscale
Slide 18: Ampligen as a Potential Treatment of Post-COVID Condition of Fatigue
Ampligen as a Potential Treatment of Post-COVID Condition of Fatigue Reduction in fatigue observed in the first patients provide preliminary evidence of Ampligen’s effect in Post-COVID condition of fatigue. Preliminary data out of the Hunter-Hopkins center for 4 patients treated for long COVID. Data
Slide 19: Ampligen as a Potential Treatment of Post-COVID Cognitive Dysfunction
Ampligen as a Potential Treatment of Post-COVID Cognitive Dysfunction Preliminary Data: Post-COVID Cognitive Dysfunction Patient Questionnaire Score Cognitive Dysfunction Mi Baseline Mi Week 24 Patient Questionnaire asked: “Please mark on the scale the degree that the symptom has affected you in the
Slide 20: Ampligen as a Potential Treatment of Post-COVID Chronic Fatigue-Like Conditions
Ampligen as a Potential Treatment of Post-COVID Chronic Fatigue-Like Conditions Status Open and Treating Patients Number of Subjects Up to 80 Brain Fog = Study Drug Ampligen ef , NWA v Primary Endpoint PROMIS’ Fatigue Score aise Joint Pain i i i Disorder Secondary Endpoint 6-minute walk test; Patien
Slide 21: Overview of Ampligen's Safety Profile
Overview of Ampligen’s Safety Profile Administered by intravenous (IV) infusion over 30 to 60 minutes Generally well-tolerated with >100,000 doses administered Extensive exposure to drug (>600 patient treatment years), including two placebo- controlled pivotal studies Favorable safety profile overal
Slide 22: No Significant Difference Between Ampligen and Placebo in SAEs
No Significant Difference’ Between Ampligen and Placebo Groups in Relationship of SAEs to Study Drug All CFS Studies? Ampligen Group Placebo Group m1=None mm 2=Remote = 3=Possible 1 4=Probable ™5=Definite 0 Percent of Patients 6 7.7% <—— withSAEs ——> 8.6% ‘Fisher’ s Exact Test, p=0.74 Sam 2 Studies
Slide 23: Safety Findings from Two Well-Controlled Pivotal Studies
Safety Findings from Two Well-Controlled Pivotal Studies (AMP502 and AMP516) No evidence of new autoimmune disease No evidence for induction of autoantibodies No increase of treatment emergent depression or suicide attempts No increase incidence of cancer 5.6 % increase in SGOT (AST) or SGPT (ALT) >
Slide 24: Wrap-up
Wrap-up Ampligen’s pre-clinical and clinical data in Ampligen is AIM Ampligen has an ME/CES strongly ImmunoTech’s broad- established, generally suggest the drug has spectrum antiviral and well tolerated clinical the potential to be an immunomodulator safety profile effective therapeutic for post-COV
Slide 25: References
References 43, 25 .AIM Chu, Valencia U, Garvert DW, Montoya JG. Onset Patterns and Course of Myalgic Encephalomyelits/Chronic Fatigue Syndrome. Front Pediatr. 2019 Feb 5;7:12. dol 10.3389/fped,2019,00012, PMID: 30805319; PMCID: PMC6370741. Yalcin S, Kuratsune H, Yamaguchi , Kitani T, Yamanishi K. Pr
Slide 26: References
References 49. 50. 51. 52. 53. 54. 55. 56. 37. 58. 59. 60. Niu J. The use of Ampligen alone or in combination with ganciclovir and conmermucin Al for the treatment of ducts congenitally infected with duck hepatitis B virus. Antiviral Research 21:155- 171, 1993, Ljichi K,, Mitamura K, Ida S,, et al.
Slide 27: References
References 2 .AIM 61, 62, 63, 64, 65, 66. 67, 68. 69, 70. n, n. Olsen A, Morrey1., Smee D., and Sidwell R, Correlation between breakdown of the blood-brain barrier and disease outcome of viral encephalitis in mice. Antiviral Research 75(2):104-12, 2007, Lee M.H,, Wilson S, Fung L-,, et al. The effec
Slide 28: References
References 28 AIM B. 7. 3. 76. 7, 78. 79. 80, 81 22, Ichinohe T., Tamura S,, Kawaguchi, A, et al. Cross-Protection against HSN1 Influenza Virus Infection Is Afforded by Intranasal Inoculation with Seasonal Trivalent Inactivated Influenza Vaccine. Journal of Infectious Disease, 196:1313-20, 2007, Sid
Slide 29: References
References 83, 85, 86, 87, Carter W., Strayer D., Brodsky L, et al. Cli related complex. Lancet i:1286-1292, 1987. smunological, and virological effects of Ampligen®, a mismatched double-stranded RNA in patients with AIDS or AIDS- ‘Armstrong J.A., McMahon D., Huang X.L, etal. A phase I study of Ampl
Slide 30: aimimmuno.com
NYSE American: AIM aimimmuno.com S AIM ImmunoTech