Humanigen February 2021 Cautionary Note Regarding Forward-Looking Statements
All statements other than statements of historical facts contained in this presentation, including information concerning our possible or assumed future results of operations and expenses, business strategies and plans, competitive position, business and industry environment and potential growth opportunities, are forward- looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding: Our expectations for timing and achievement of the key corporate and COVID-19 milestones described in the presentation, including; The target date for announcement of topline data from our Phase 3 trial of lenzilumab in COVID-19 patients; The anticipated use of lenzilumab in the ACTIV-5 Trial sponsored by NIAID, and the anticipated scope of that trial and timeline for same; Our potential request for and receipt of an Emergency Use Authorization from FDA for lenzilumab in COVID-19 and our expectations for filing a BLA; and Our plans to launch and commercialize lenzilumab following receipt of the requisite regulatory authorizations or approvals; and Our expectations for timing and achievement of milestones for our pipeline outside of COVID-19, including in respect of our ZUMA-19 Phase Ib trial of lenzilumab that is being conducted with Kite, a Gilead company; our ongoing Phase I trial of ifabotuzumab in GBM patients; our plans for a study of lenzilumab in GvHD expected to be conducted with the IMPACT Group in the United Kingdom and a study in the US, and our plans for a study of lenzilumab in CMML in Australia; Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements, as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
2 Company Highlights
1 Leading expertise in Hyper-inflammation and Cytokine Storm across multiple therapeutic applications
520 patient Phase 3 registration study in COVID-19 fully enrolled, top-line in March 2021; 2 ACTIV-5 200 patient, fully-sponsored COVID-19 BET study enrolling
Strong mid-to-late stage clinical pipeline including potential registration studies in CAR-T (US) 3 and GvHD (UK); collaboration with Kite/Gilead in CAR-T
Potential Emergency Use Authorization, commercial readiness and manufacturing scale-up 4 underway
Backed by blue-chip institutional shareholders, including Valiant, Citadel, Point 72 and Blackrock 5 as well as management
6 Experienced and execution-oriented management with prior launch experience
3 Lenzilumab Overview
Lenzilumab is a first-in-class mAb in a Phase 3 study to prevent the cytokine release syndrome in COVID-19 hospitalized patients.
Reduce risk of progression to IMV and/or death Lenzilumab, a dual action monoclonal antibody, which safely replenishes T-Cells and dampens the harmful inflammatory response, can be administered intravenously over a single day, to newly hospitalized and hypoxic COVID-19 patients, who may or may not have received other COVID-19 therapies.
First-in-Class, Novel MOA Potential Outcomes Convenient Care (Mayo Case Cohort Study) ✓ Neutralizes GM-CSF to prevent ✓ For all hospitalized patients with cytokine storm ✓ 80% relative risk reduction of SARS-CoV-2 pneumonia pre-IMV ventilation (IMV) and/or death ✓ ✓ Reduces immunogenicity ✓ Reduced time to clinical Administered IV in a single day improvement by 6 days1 ✓ Higher binding affinity ✓ Can be combined with current ✓ No serious adverse events observed standard of care across multiple studies
1Mayo Clinic Study, GM-CSF Neutralization With Lenzilumab in Severe COVID-19 4 Clinical-Stage Pipeline
Indication Phase Status Centers Partners Potential Registration Enabling Enrollment Prevention / treatment of 24 US 3 complete Hyper-inflammation / 520 11 Brazil Cytokine Storm Company sponsored ACTIV-5/BET Prevention / treatment of Enrolling 2 Up to 40 sites Hyper-inflammation / 200 patients Cytokine Storm ZUMA-19: Lenzilumab Break CAR-T Efficacy/Toxicity Linkage 10 sites 1b/21 Recruiting Prophylaxis as sequenced therapy with Including MD Anderson and Yescarta in r/r DLBCL other ZUMA-1 sites
Prevention/Treatment of Acute GvHD Advanced 2/3 Up to 23 sites2 Allogeneic HSCT planning
CMML Advanced Undisclosed Lenz + azacitidine in NRAS, KRAS or CBL 2 planning mutant-positive newly-diagnosed patients
3 Solid Tumors Active, fully Ifabotuzumab 1 (Glioblastoma Multiforme) recruited
1 Phase 3 may not be necessary for approval in ZUMA-19; precedent is CAR-Ts to date have been approved on Phase II data 2 UK 3 Australia 5 Accomplishments and Objectives
2020 2021
✓ Mayo case-controlled publication ✓ Phase 3 full enrollment complete ✓ ACTIV-5/BET NIH fully-sponsored 200 patient ❑ Phase 3 topline data March 2021 study (lenzilumab + rem vs. rem alone) ❑ ACTIV-5 topline data ✓ Outlicense Korea + Philippines rights to ❑ Application for Emergency Use Authorization KPM/Telcon ❑ Commercial distribution under EUA if granted ✓ CRADA* with DoD/BARDA in support of Operation Warp Speed ❑ BLA submission ✓ Ifab GBM study enrollment completed ❑ ZUMA-19 Phase 1b CAR-T data ✓ First Lenz CAR-T patent issued ❑ Initiate GvHD study with IMPACT Group
*Cooperative Research and Development Agreement 6 Experienced and Execution-Oriented Management
David Tousley, CPA, MBA – Chief Accounting and Administrative Cameron Durrant, MD, MBA – Chief Executive Officer Officer, Corp Secretary and Treasurer Serial biotech experience as Exec Chair, CEO, CFO Significant pharmaceutical and biotech experience Led previous deals with Gilead while at J&J Led many corporate functions, including finance and accounting Launched 5 blockbusters Raised $400+ million in equity and debt financings
Ed Jordan, MBA – Chief Commercial Officer Tim Morris, CPA – Chief Operating and Financial Officer Senior commercial roles, across the heathcare industry CFO Iovance; raised > $2Bn in 22 years as CFO Extensive product launch experience including immunology, oncology, hematology Extensive deal experience with >75 transactions, combined value $4B
Bob Atwill, MBA – Head of Asia-Pacific Region 30 years of biopharma experience, including cell therapy Extensive network in Asia-Pacific, BD+L, fundraising and clinical development Dale Chappell, MD, MBA – Chief Scientific Officer Founder, Black Horse Capital Advisors; decades of biotech investment experience Head of healthcare portfolio, Chilton Investment Company Omar Ahmed, PharmD – SVP. Clinical, Medical and Scientific Affairs Multiple publications in T-cell therapy, GM-CSF, immunology pathways 20-year pharmaceutical executive experience Led multiple blockbuster launches Led development of Janssen’s immunology portfolio strategy
7 Preparations for Commercialization Ongoing
Chief Commercial Officer Preparing for Commercialization ✓ Go-To-Market Strategy ✓ Market Research ✓ Third Party Logistics ✓ Specialty Distributor ✓ Contract Commercial Organization
Edward P. Jordan, MBA ✓ Packaging • Broad commercial and leadership experience ❑ Field teams • Extensive product launch experience ❑ Fact sheet and distribution • Experience building biotech companies and preparing ❑ Educational support for biologic commercialization • Therapeutic expertise– Immunology/Allergy, Oncology, Anticipated Timelines Respiratory, Women's Health • Emergency Use Authorization – H1 2020 • Broad Commercialization – H2 2021
8 1 Therapeutic for COVID-19 Patients
2 Prevention / Treatment of Acute GvHD
3 Market Potential/Financial overview
9 Neutralization of GM-CSF to Prevent COVID-19 Cytokine Storm
GM-CSF neutralization prevents CD14+CD16+ inflammatory myeloid cell activation and reduces all downstream monokine production
IL-6 blockade reduces only IL-6 and does not block inflammatory myeloid cells activation and all downstream monokine production
IL-6 blockade alone has not shown clinical utility as a preventative measure in CAR-T induced Cytokine Storm – IL-6 and IL-1 inhibitors have failed in studies in COVID-19
Three recent independent publications support role of GM- CSF as signature cytokine for hyperinflamation in COVID- 19
Diagram: Temesgen, Zelalem et al. “GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Control Study.” 03 Sep. 2020 10 Clinical Studies of Lenzilumab: No Serious Safety or Tolerability Issues
Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM- CSF Monoclonal Antibody Lenzilumab in Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome from Biologic Therapy 9 subjects (5 dosed at 10 mg/kg or 600mg flat dose); study terminated after lead-in phase due to portfolio prioritization HGEN003-02 No deaths, DLTs or SAEs related to study drug, or discontinuations due to AEs No subject reported any infusion-related reaction No subject developed adverse respiratory signs and symptoms Significant improvements in ACR20, ACR50 and CRP relative to placebo
Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Lenzilumab in Severe Asthma Inadequately Controlled by Corticosteroids 160 subjects randomized; 81% (63) of subjects randomized to drug received all of the 7 doses per protocol Subjects in the lenzilumab group had treatment-emergent AE similar to placebo; No treatment related SAE *HGEN003-04 4 subjects in the lenzilumab group vs 2 in placebo reported an infusion-related reaction (mild-mod, no severe infusion- reactions) No deaths were reported or Pulmonary Alveolar Proteinosis (PAP) diagnosis reported Statistically significant improvement in FEV1 (227 mL) in pre-specified eosinophilic asthma group
* BMJ, 2016 11 Lenzilumab Phase 3 in Severe or Critical COVID-19
Multicenter, randomized, double-blind, placebo-controlled pivotal trial NCT 04351152
Adults ≥ 18 yrs Daily assessment through Day 28 for Lenzilumab 600mg IV Q8h x 3 on Day 1 1° and 2° endpoints while hospitalized; Hospitalized, confirmed SARS-CoV-2 Severe or Critical COVID-19 pneumonia If discharged, follow-up assessments SpO2 ≤ 94% and pre IMV Placebo IV Q8h x 3 on Day 1 (N = 520, 1:1) on Days 28 and Day 60
▪ Primary Endpoint: ▪ Ventilator Free Survival
All subjects receive institutional standard of care which may include remdesivir or corticosteroids
12 Mayo Clinic Case-Control Trial Design
• Case-control study (n=39) • 12 patients treated with lenzilumab • Lenzilumab treated patients dosed with 600 mg intravenously for three doses • Contemporaneous standard of care control patients selected from electronic medical records from across Mayo clinic enterprise (n=27) • Substantial number of standard of care control patients received other COVID-specific treatments • Outcomes of control patients unknown at time of selection. • Patients matched for age, gender, disease severity
Source: Temesgen, Zelalem et al. “GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Control Study.” 03 Sep. 2020 13 Mayo Clinic Case-Control Trial Baseline Characteristics
Table 1. Demographics and baseline characteristics Characteristic Lenzilumab group (n=12) Control group (n=27) P-value Age, y 65 (52-70) 68 (61-76) .25 • Patients matched for baseline Male 8 (67%) 19 (70%) > .99 Female 4 (33%) 8 (30%) > .99 characteristics Race White 9 (75%) 17 (63%) .79 Asian 2 (17%) 5 (19%) > .99 • Lenzilumab group has slightly American Indian/Native American 1 (8%) 0 (0%) .36 Comorbidities higher COVID-19 relative risk Diabetes mellitus 7 (58%) 14 (52%) > .99 Hypertension 7 (58%) na na Obesity (BMI > 30) 6 (50%) 9 (33%) .54 factors Coronary artery disease 2 (17%) 4 (15%) > .99 Kidney transplantation 1 (8%) na na • DM2, HTN, BMI Obstructive lung disease 4 (33%) na na Chronic obstructive pulmonary disease 2 (17%) 11 (41%) .47 Reactive airway disease 1 (8%) na na • CRP elevated in lenzilumab Temperature (degrees Celcius) 38 (37.25-38.5) 37.5 (37.1-38.4) .76 Inflammatory markers before treatment group but T cell counts similar CRP (<= 8.0 mg/L) 103.2 (52.7-159.9) 74.4 (42.2-131.5) .25 Ferritin (24-336mcg/L) 596.0 (358.3-709.0) 673.0 (406.8-1012.8) .75 IL-6 (<= 1.8 pg/mL) 30.95 (24.18-34.05) 29.20 (13.55-40.70) .87 • Oxygen therapy equally D-dimer (<=500 ng/mL) 829 (513.5-1298.5) 916.0 (585.0-1299.0) .84 Lymphocyte count before treatment (0.95-3.07x10^9/L) 0.75 (0.55-1.04) 0.76 (0.59-1.01) .91 matched Oxygen therapy before treatment Nasal cannula (=4 clinical ordinal endpoint scale) 8 (67%) 20 (74%) > .99 High-flow oxygen/NIPPV (=3 clinical ordinal endpoint scale) 4 (33%) 7 (26%) .73 Invasive ventilation (=2 clinical ordinal endpoint scale) 0 (0%) 0 (0%) > .99 SpO2/FiO2 before treatment 280.9 (252.5-317.9) 289.1 (254.9-342.0) .98
14 Lenzilumab Significantly Improved Clinical Outcomes
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15 Lenzilumab Rapidly Improves Oxygenation Status
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ControlControl RepeateRde pmeeaatesudr mese aAsNuOreVsA A, NPO 16 Lenzilumab Reduces Risk of Ventilation/Death Table 2. Clinical Outcomes Lenzilumab group (n=12) Control group (n=27) P-value Incidence of clinical improvement 11 (92%) 22 (81%) .43 Days to clinical improvement 5 (1 - 14) 11 (4 - 42) .006 Days to discharge from hospital 5 (3-19) 11 (4 - 42) .008 Mean temperature reduction 1.075 0.459 .02 Days to resolution of fever 2 (1-6) 1 (1-3) .22 Incidence of IMV 1 (8%) 10 (37%) .10 Incidence of death 1 (8%) 5 (19%) .43 Incidence of IMV and/or death 1 (8%) 11 (41%) .07 Table 3. Laboratory Markers Lenzilumab group (n=12) Control group (n=27) P-value CRP reduction 135.8 -0.95 .01 IL-6 reduction 20.1 na na ALC increase 0.46 x 10^9/L 0.03 x 10^9/L .04 PLT increase 52.5 63.2 .61 17 Lenzilumab Phase 3-Interim Analysis Disease Stratification N=165 • Patient characteristics for first 165 SpO2<94% or Low-flow 65% High-flow or NIPPV 35% patients show good distribution of: Age Stratification 18-64 years 55% • Disease severity >65 years 45% • Age Diversity • Diversity Hispanic / Latino 28% Black / African American 22% Concomitant Therapies • Extensive use of concomitant Dexamethasone (or other steroids) or Remdesivir 94% therapies Dexamethasone (or other steroids) 90% Remdesivir 66% Dexamethasone (or other steroids) + Remdesivir 62% • Estimated HR of 1.37 suggests Interim Analysis 37% increase in recoveries with Observed Hazard Ratio 1.37* lenzilumab across the 28-day Events Planned 257 period DSMB Recommended Events 402 Power at New Event Rate 90% * Benefit that is in addition to any benefit from steroids and/or remdesivir in the control arm 18 ACTIV-5/BET Big Effect Trial (BET-B) for the Treatment of COVID-19 Double-blind, placebo-controlled study of 200 patients, NIH-sponsored, up to 40 US sites NCT 04583969 • Lenzilumab is the third of six agents selected by NIH, the only GM-CSF molecule selected • Over 400 compounds reviewed by NIH for inclusion in ACTIV protocols • Humanigen is the only small company in NIH-sponsored studies • NIH has awarded contracts totaling ~$26M to support the study, HGEN providing lenz • NIH will conduct the study, HGEN and NIH collaborated on protocol • First subject dosed, enrollment ongoing • Planned interim analysis for efficacy at 50% enrollment • Study expands number of patients for BLA submission and potential label to include use with remdesivir 19 1 Therapeutic for COVID-19 Patients 2 Improving efficacy / safety of CAR-T 3 Prevention / Treatment of Acute GvHD 4 Market Potential/Financial overview 20 Lenzilumab Significantly Reduces Neurotoxicity and Prevents CRS Plenary presentation at ASH provides scientific rationale for Kite Collaboration Day 5 post-CAR-T infusion Lenzilumab Prevents CRS 75% reduction in NT with Lenz + CAR-T Background neuro- 140% inflammation in CART19 tumor-bearing Baseline prior prior Baseline to mice 120% 100% CAR-T without lenzilumab 80% 60% CART19 cells + + cells CART19 control antibody control Gadolinium enhanced hyperintensity hyperintensity (cubicmm)* 40% - T1 (Percent (Percent Increase from Baseline) 1 20% CAR-T with lenzilumab 0% Lenzilumab Baseline (prior to CAR-T + CAR-T + Control CART19 cells + + cells CART19 CAR-T) Lenzilumab Antibody 1mGM-CSF blockade also added to account for murine GM-CSF *Quantitative MRI using volumetric analysis to measure neuro-inflammation by T1 hyperintensity Sterner, et al. Blood 2019 133:697-709; doi: https://doi.org/10.1182/blood-2018-10-881722 21 Benefits Of Deal Structure To Humanigen ▪ Non-exclusive deal ▪ Humanigen retains 100% of lenzilumab economics ▪ Multicenter trial with CAR-T world leader ▪ Significant costs funded by external party ▪ Leverages Kite development infrastructure 22 ZUMA-19 Potential Registration Study ZUMA-19 Phase 1b Phase 2 • 3+3 Design to find recommended phase II dose ▪ At Recommended Dose • Cohort 1 with Starting Dose • Cohort 2 with Escalating Dose Endpoints Efficacy Safety • Complete Response (CR) • Minimizing Toxicities • Partial Response (PR) • NT • Objective Response Rate (ORR) • CRS • Duration of Response (DOR) • Days in ICU (Exploratory) Clinical Trial Design Trial Clinical • Progression Free Survival (PFS) • Days on Vasopressors (Exploratory) • Overall Survival (OS) • % Patients with observed T-cell expansion • Kinetics of T-cell expansion Day -5,-4,-3 Day 0 Day 28 Primary endpoint for Leukapheresis CAR-T ~ 6 Months NT / other key measures Top Line Data for Lenzilumab Infusion Durable Response Evaluation of T-cell kinetics Dosing Schedule Dosing Lymphodepleting Chemotherapy (Cyclophosphamide/Fludarabine) Ongoing follow-up for safety and efficacy ClinicalTrials.gov Identifier: NCT04314843 23 1 Therapeutic for COVID-19 Patients 2 Improving efficacy / safety of CAR-T 3 Prevention / Treatment of Acute GvHD 4 Market Potential/Financial overview 24 GM-CSF Blockade Reduces GvHD Mortality Proof of concept study demonstrates role of GM-CSF in GvHD GM-CSF k/o (CSF2-/-) improves GvHD survival Anti-GM-CSF antibody improves GvHD survival BM Only WT splenocytes Csf2-/- splenocytes BM Only WT + isotype WT + a–GM-CSF WT + PBS Ifng-/- splenocytes II17a-/- splenocytes 100 100 80 80 60 60 Survival (%) Survival Survival (%) Survival 40 *** 40 ** 20 20 ** 0 * 0 0 5 10 15 20 0 5 10 15 20 Days after HCT Days after HCT Tugues et al., Sci. Transl. Med. 10, eaat8410 (2018) 25 IMPACT Partnership/HGEN GvHD Trial Design N= 240 Patients Phase 2 (case-cohort) • Screened 40 patients • 20 treated with lenzilumab • Go/no-go decision Phase 3 • Screened 215/yr • Randomized 110/yr • Total sample size 220 randomized 1:1 Clinical Trial Design Trial Clinical Day 0 Day 28 6 Months Intermediate + High Allo Lenzilumab + SOC GvHD Dx Risk (AA2+AA3) Transplant Randomized vs. Response rate NRM assessment Placebo + SOC assessment MAGIC biomarker (<48 hours Low Risk SOC post Dx) Ongoing follow-up for safety and efficacy Dosing Schedule (every 2 weeks) 2 (every Schedule Dosing 26 1 Therapeutic for COVID-19 Patients 2 Improving efficacy / safety of CAR-T 3 Prevention / Treatment of Acute GvHD 4 Market Potential / Financial overview 27 Lenz Commercial Preparation Underway Humanigen is positioned for commercial success in 2021 and beyond. 1 Anticipated lenzilumab EUA in 1H2021 and BLA filing in 2H2021 2 Unique MOA addressing an unmet need in the quest for effective COVID-19 treatments 3 $1B peak opportunity estimated for lenzilumab in hospitalized and hypoxic COVID-19 patients 4 Anticipate favorable access and reimbursement to support rapid lenzilumab uptake 5 Commercial organization is swiftly scaling and resourced for a successful launch, if EUA granted 6 Experienced leadership team with deep expertise and a proven commercial track record 28 COVID-19 Disease Landscape The COVID-19 pandemic has affected millions and put significant strain on global healthcare systems and institutions. 26 Million+ 439,000+ US COVID Cases1 US COVID Deaths1 4% 89%4 ~13.5K Of All Cases of Hospitalized Average Daily Cost to Require Patients are Treat Hospitalized Hospitalization2 Hypoxic COVID Patients3 1. Johns Hopkins Coronavirus Resource Center 2. Total Hospitalizations÷ Total Cases (COVID Tracking Project / Johns Hopkins Coronavirus Resource Center) 29 3. Fair Health Report as reported in Healthcare Finance News (November 5, 2020) 4. ACTT-2 Sizeable and Sustainable Market Opportunity The number of hospitalized COVID-19 patients is expected to rise beyond current levels and remain significant through 2022 and beyond2 ~677,000 COVID-19 COVID-19 Hospitalizations Hospitalizations in 20201 Despite a vaccine, hospitalizations will increase 600K+ Hospitalizations Anticipating a Greater Despite herd immunity and Number of Hospitalizations widespread vaccinations, in 2021 hospitalizations remain Hospitalizations Will Remain Through 2022 and Beyond 2020 2021 2022 and Beyond 1. Covid Tracking Report 2. Data on file 30 Future Need For COVID-19 Therapeutics There is consensus across the industry that hospitalizations and the need for therapeutics will continue well into 2021 and beyond. “While safe and efficacious vaccines are a large step forward towards ending the COVID-19 crisis…there will be a continued need for novel anti-inflammatory and immunomodulatory compounds.” - Dr. Matthew Robinson, Austin Infectious Disease Consultants3 KOL Call Highlights Continued Need for New COVID-19 Therapeutics Even with Vaccines December 3, 2020 “2021 revenue is expected to be between $26.5 billion and $28.0 billion, HHS said it would rapidly distribute Regeneron's 300K driven by … an estimated $1 billion to $2 billion of revenue from doses of COVID-19 antibody drug to states by end of COVID-19 therapies.”1 January 1. Eli Lilly Press Release: December 15, 2020 2. Regeneron Press Release: November 21, 2020 31 3. H.C. Wainwright, Joseph Pantginis, Ph.D.: December 3, 2020 Disease Progression There are 3 key phases of disease progression—early infection, pulmonary / inflammatory, and hyperinflammatory. COVID-19 Disease Progression 1 Early Infection Phase 2 Pulmonary/Inflammatory Phase 3 Hyperinflammatory Phase Disease Viral Acute Response Onset Cytokine Storm ➢ COVID-19 can cause uncontrolled inflammatory responses— ➢ Patients are often asymptomatic during the first ~5 days aka the “Cytokine Storm”—characterized by marked pro- following infection, followed by denial, at a point when the inflammatory cytokine release in patients viral load is highest ➢ These SARS-CoV-2-induced immune abnormalities may lead ➢ Viral replication can lead to an onset of mild symptoms, to respiratory failure, cardiac failure, neurological changes, such form of fever, muscle pain, fatigue, and/or cough DIC, and multi-organ failure 32 Patient Journey There is a significant therapeutic need for those COVID-19 Patients Hospitalized and Hypoxic COVID-19 Disease Progression 1 Early Infection Phase 2 Pulmonary/Inflammatory Phase 3 Hyperinflammatory Phase Patient Outpatient In Hospital Journey COVID-19 Outpatient Symptom Present to Hospital with Hypoxia Low Flow or High Flow Invasive Mechanical Diagnosis Management (SpO2<94% on Room Air) Supplemental O2 Ventilation Treatment OTC Treatments Remdesivir Options Patients quarantine & manage symptoms at home Optimal efficacy when viral load is highest, but often given too late. Efficacy is questionable.1,2 Neutralizing mAbs Corticosteroids Patients required to present to Most effective in IMV patients. outpatient infusion centers Concerns remain when administered too early Bamlanivimab Treatment Opportunity Casirivimab + Imdevimab Need for an effective therapy that interrupts immune hyper-response and prevents disease progression in hospitalized patients 1. “Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.” Wang et al. Lancet. 2020 May 16; 395 (10236): 1569-1578 2. WHO Solidarity Trial 33 Key Stakeholders To bring lenzilumab to market, we will focus on addressing the needs of three stakeholders—patients, providers, and payers. Patients Providers Payers / Hospitals Understand the needs of hospitalized Help physicians understand the value Work with hospital systems and key COVID-19 patients and support them lenzilumab can contribute to better institutions to ensure patients get in their treatment patient outcomes timely access to treatment 34 Patient Perspectives The emotional toll hospitalizations place on patients and their families is significant. The Median Hospital length of stay for survivors is 10 – 13 days1 COVID-19 symptoms can linger for months with long-term effects on the lungs, heart and brain2 Cost of hospital care can be significant and exceed $150K per patient3 1. CDC: Interim Clinical Guidance for Management of Patients with Confirmed COVID-19 2. Mayo Clinic: Coronavirus: Long-term Effects 35 3. Fair Health Report as reported in Healthcare Finance News (November 5, 2020) Target Physicians Infectious Disease Physicians, Pulmonologists, and Critical Care Physicians Oversee Treatment Decisions for Hospitalized COVID-19 Patients Concentration of COVID-Cases (3% of US Counties Represent 43% of Total Cases) ~34.5K COVID Specialists 13,500 12,000 Pulmonologists 9,000 Identify Specialists in Urban Areas with High Number of COVID Cases Pulmonologists Infectious Disease Critical Care Physicians Physicians 1. PUD Source: NCBI – HHS Author Manuscript (~12k) 2. ID Source: The Lancet: Infectious Disease (~9k) 36 3. CC Source: Society of Critical Care Medicine (~13.5k) Physician Perspectives Findings from commissioned market research indicate physicians will prescribe lenzilumab however awareness is low1 The Burden of COVID-19 Will Continue Managing The Cytokine Storm Is Critical • Hospitals and staff are overwhelmed • HCPs understand the importance of managing the immune response early to prevent disease progression • Targeted HCPs are eager to reduce COVID-19 hospitalizations and discharge patients sooner • There is a lack of effective treatment options for hospitalized and hypoxic patients • Despite vaccines, HCPs do not anticipate COVID-19 hospitalizations disappearing • Despite vaccines, there will be a continued need for anti- inflammatory and immunomodulatory compounds Current Therapies Are Inadequate Lenzilumab Product Profile Is Promising • Remdesivir is often given too late, and may not be effective in • Majority of prescribers are “Very Likely” to use Lenzilumab in hospitalized patients (reference from WHO Solidarity Study) their hospitalized and hypoxic patients • Corticosteroids have associated risks and should be reserved • Impressed by lenzilumab efficacy profile and improvement in from IMV patients, avoided in high-risk patient populations potential clinical outcomes • HCPs recognize the complexity of administration of • The novel MOA targeting GM-CSF and safety profile make neutralizing antibodies in an outpatient setting lenzilumab an ideal candidate for treatment of COVID-19 1. Internal market research Q4 2020, n=15 37 Hospital Access and Reimbursement Landscape Hospital Systems and key institutions recognize the need to reduce costly hospitalization days and intubations. • COVID-19 patients can be hospitalized for a week or more, possibly in the ICU • Cost of care is estimated at ~$13K per day for a hospitalized patient • Inpatient COVID-19 drug therapies are currently covered by Medicare Part A • In a study, lenzilumab reduced the number of hospitalization days (5) vs. standard of care (11) • 80% reduction in relative risk of IMV or death Given the current market needs and lenzilumab’s unique product profile, we anticipate broad coverage. 38 Go-To-Market Partner To help bring lenzilumab to market, we are partnering with an end-to-end commercial partner—Eversana. ➢ Full launch & Rationale For Selecting End-To-End Partner commercialization engine ➢ Ready-to-deploy with real- ✓ Maintain control of lenzilumab time operational optimization ✓ Enhance flexibility and scalability ➢ Dedicated commercial ✓ Leverage significant launch experience team backed by 3,000+ employees ✓ Reduce commercial risks We stand ready to immediately activate“ our services spanning all disciplines of the product journey to ensure this therapy achieves optimal ✓ Minimize financial exposure market growth and measurable patient value,” said Jim Lang, chief “executive officer of EVERSANA. ✓ Maximize reward An end-to-end commercial partner provides ultimate flexibility, allowing us to quickly scale for a successful launch if EUA is granted 39 Lenzilumab Launch Planning The current launch strategy will be supported by six Eversana functional teams Pre-Approval EUA Authorization BLA Submision/Approval Target Timeframe January 2021 H1 2021 H2 2021 Prepare educational resources, within Drive brand awareness, trial and Objective Build foundation for launch execution. guidelines, to address questions and acceptance. make product available. Gap Analysis to drive launch strategy Coordination of launch activities with Management and plan. Define HCP, KOL and patient milestone tracking and reporting. HCP Align on Payer/Contracting Strategy Consulting journey mapping for both EUA and BLA and Patient Segmentation & Customer phases. Engagement Model Develop omni channel strategy and Create and launch Lenzilumab website Launch ’Now Approved’ branded Marketing Agency create communication strategy for both landing page with FAQ. Create disease website, Payer Resources, HCP and EUA and BLA phases. education resources. patient creative campaign. Data acquisition to inform HEOR, HCP Data integration and mastering to coordinate data sources into one platform Commercial targeting, hospital segmentation, and capturing market access, marketing, Salesforce, CRM and overall performance Operations territory alignment. metric capture with incentive compensation capabilities. Recruit MSL/NAM field team and Deploy National Account Managers and Complete training and Launch develop training plan and train initial MSLs teams (9). Recruit additional field Field Teams Customer facing team (+49) in addition field team. Build foundation to support sales team members and build to existing NAM and MSL team. and manage initial field team. executional tools. Refine payer resources, updated Market access landscape mapping with Value Brief and Budget Impact Model dossier to execute payer access Managed Markets claims analysis, manuscripts, abbreviated with cost-offsets. strategy. Value message testing. Track dossier. product access. Provide connectivity and ongoing Complete Quality Assessment to ensure Launch and Manage MI Call Center, support between the sales team and Medical Education and compliance. Establish 1.800 number adverse event reporting and deploy the requests for medical information for Pharmacovigilance and setup call center. Complete MIRF/SRL capabilities. Set up product Medical Science Liaison team. KOL medical writing for FAQs and SRLs. safety database. 40 speaker education. Established Manufacturing Agreements for Lenzilumab Bioreactor (BDS) batches • Catalent - Madison, WI Manufacturing Partners • Catalent - Bloomington, IN • ThermoFisher - S t. Louis, MO • Avid Biosciences - Tustin, CA Drug Product (DP) vials • Emergent - Baltimore, MD • Ajinomoto - San Diego, CA Packaging • Additional CMO’s selected • Catalent - Philadelphia, PA (clinical) Bulk Drug Drug Product Supply Supply Specialty BDS Vials Substance Fill/Finish (Vials) Packaging Distribution Distributor Cardinal Health Engaged multiple contract manufacturing organizations (CMOs) to scale-up and optimize the manufacturing process to meet a target of supplying ~100,000 treatment courses within 12 months 41 Financial Overview Uplisting to NASDAQ Achieved on September 18, 2020 Balance at December 31, 2020 (M)* • Cash and cash equivalents $68 • Shares outstanding 55 *balances are unaudited 42 Upcoming Catalysts and Goals 1 Topline data Phase 3 lenzilumab in COVID-19 2 Complete recruitment in ACTIV-5 3 EUA submission and subsequent approval 4 Prepare for EUA distribution and scale-up manufacturing, BLA 5 Continue CAR-T recruitment and initiate GvHD study 43 Competitive Landscape Immunomodulatory Agents for Hospitalized COVID-19 Pts (except Neutralizing mAbs) Overview of Investigational Agents in Mid-Late Stage Development for Treatment of SARS-CoV-2 Associated Cytokine Storm Anti-GM-CSF mAbs Anti-IL-6 & Anti-IL-1 mAbs Tocilizumab (Actemra®) Phase 3 (Global) Roche: FAILED anti-IL-6R Phase 3 (US) Genentech Lenzilumab Phase 3 Sarilumab (Kevzara®) Phase 2/3 (US) Regeneron: FAILED anti-IL-6R Phase 3 (Ex-US) Sanofi GSK - Data Q1 could move Siltuximab (Sylvant®) Otilimab Phase 2 Phase 2 (EU) EUSA: DELAYED to P3 study anti-IL-6 Sirukumab (unapproved) Phase 2 (US) Janssen: DELAYED Gimsilumab Phase 2 Roivant (Kinevant): FAILED anti-IL6 Canakinumab (Ilaris®) Phase 3 (Global) Novartis: FAILED Plonmarlimab Phase 2/3 I-Mab: DELAYED anti-IL-1β Anakinra (Kineret®) Phase 3 (EU) SOBI: FAILED Roivant (Kinevant) anti-IL1Ra Namilumab Compassionate Use (Italy) Izana Oral JAK & BTK Inhibitors ACTT-2: EUA (+ Remdesivir) NIAID Mavrilimumab* Phase 2/3 Kiniksa Baricitinib ACTT-4: Bari+Rem vs Dex+Rem NIAID (Olumiant®, JAK1/2) Lilly Phase 3: DELAYED Lilly SARS-CoV-2 Neutralizing mAbs Ruxolitinib Phase 3 (US): DELAYED Incyte Severe (+ Rem) NIH/Lilly: FAILED (Jakafi®, JAK1/2) Phase 3 (Global): FAILED Novartis Bamlanivimab Acalabrutinib Mild-Mod (Mono) NIH/Lilly: EUA 2 Phase 2 studies: FAILED Astrazeneca Bamlanivimab NIH/Lilly: EUA (Calquence®, BTK) Mono, Mild-Mod Combo, Mild-Mod ® + Etesevimab Lilly: Phase 2 Ibrutinib (Imbruvica , BTK) Phase 2 (US): DELAYED Abbvie Abivertinib (Sorrento) Phase 2 (US): DELAYED Sorrento Casirivimab Mild-to-Mod Outpatient Only Regeneron: EUA + Imdevimab Other MOA Casirivimab Severe: High Flow Regeneron: FAILED Regeneron: Leronlimab (anti-CCR5 mAb) Phase 2/3 (US) CytoDyn DELAYED + Imdevimab Severe: Low Flow Ravulizumab (Ultomiris®, C5 inhibitor) Phase 3 (US): FAILED Alexion Phase 3 (US): Positive Data AR-701 + AR-711: IV Human IgG1 Aridis: Phase 1/2 Mod-Severe Hospitalized pts Saccovid (CD24Fc) OncoImmune mAb cocktail planned 1H 2021 Acquired by Merck SNG001 (inhaled IFNb-1a) Phase 2 (UK) Synairgen Aridis: Phase 1/2 Molnupiravir (MK-4482, oral antiviral) Phase 2/3 (UK): DELAYED Merck AR-711: Inhaled Human IgG1 mAb Mild-Mod (Outpatient) planned 1H 2021 Remestemcel-L (Mesenchymal Stromal Cells) Phase 3 (US): FAILED Mesoblast *anti-GM-CSFR mAb 44