Exhibit 99.1
EXECUTIVE SUMMARY
CD12_COVID19 STUDY
04Mar2021
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
TABLE OF CONTENTS
1. 
SUMMARY 
7  
1.1 
SUMMARY FIGURES 
10  
2. 
INTRODUCTION 
16  
2.1 
Disease Background 
16  
2.2 
Leronlimab (PRO 140) 
16  
3. 
STUDY OVERVIEW 
16  
3.1 
Patient Population 
17  
3.2 
Endpoints 
17  
3.3 
Analysis Population 
18  
3.3.1 
Subgroup analysis  Age group  18  
3.4 
Results Description 
18  
3.4.1 
Primary endpoint (Allcause mortality at Day 28)  19  
3.4.2 
Primary endpoint (Allcause mortality at Day 28) – Additional Analyses  19  
3.4.3 
Patients achieving OS 6 or higher (Discharged alive)  21  
3.4.4 
Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)  22  
3.4.5 
Length of hospital stay (days)  23  
3.5 
Safety Analysis 
24  
4. 
SUMMARY TABLES 
25 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
List of InText Figures
Figure 11: AllCause Mortality, Day 28 
10  
Figure 12: AllCause Mortality (Day 28), Prior and Concomitant COVID19 Treatment 
11  
Figure 13: AllCause Mortality (Day 28), Prior and Concomitant Dexamethasone Use 
12  
Figure 14: Ordinal Scale 6 or higher (Discharged alive) 
13  
Figure 15: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) 
14  
Figure 16: Length of Hospital Stay (Days) 
15 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
List of InText Tables
Table 11: 
Effect of Randomization by Age on 28Day AllCause Mortality  7  
Table 41: 
Analysis Population, All Subjects  25  
Table 42: 
Summary of Demographics, mITT Population  25  
Table 43: 
Mortality Status at Day 28, mITT Population  26  
Table 44: 
Mortality Status at Day 28, > 65 years, mITT Population  26  
Table 45: 
Mortality Status at Day 28, £ 65 years, mITT Population  26  
Table 46: 
Mortality Status at Day 28  Ordinal Scale 2 at Baseline, mITT population  27  
Table 47: 
Mortality Status at Day 28  Ordinal Scale 2 at Baseline, > 65 years, mITT population  27  
Table 48: 
Mortality Status at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, mITT population  27  
Table 49: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, mITT Population  28  
Table 410: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, > 65 years, mITT Population  28  
Table 411: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, £ 65 years, mITT Population  28  
Table 412: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, mITT Population  29  
Table 413: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, > 65 years, mITT Population  29  
Table 414: 
Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population  29  
Table 415: 
Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, mITT Population  30  
Table 416: 
Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, > 65 years, mITT Population  30  
Table 417: 
Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, £ 65 years, mITT Population  30  
Table 418: 
Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use  Ordinal Scale 2 at Baseline, mITT Population  30 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 419: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, mITT Population  31  
Table 420: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, > 65 years, mITT Population  32  
Table 421: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, £ 65 years, mITT Population  33  
Table 422: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, mITT Population  34  
Table 423: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, > 65 years, mITT Population  34  
Table 424: 
Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population  34  
Table 425: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, mITT Population  35  
Table 426: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, > 65 years, mITT Population  36  
Table 427: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, £ 65 years, mITT Population  37  
Table 428: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, Rank ANCOVA, mITT Population  38  
Table 429: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, > 65 years, Rank ANCOVA, mITT Population  38  
Table 430: 
Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, Rank ANCOVA, mITT Population  39  
Table 431: 
Summary of Length of Hospital Stay (Days), mITT Population  40  
Table 432: 
Summary of Length of Hospital Stay (Days), > 65 years, mITT Population  40  
Table 433: 
Summary of Length of Hospital Stay (Days), £ 65 years, mITT Population  40  
Table 434: 
Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, mITT Population  41  
Table 435: 
Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, > 65 years, mITT Population  41  
Table 436: 
Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population  41 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 437: 
Overview of Adverse Events, Safety Population  42  
Table 438: 
Overview of Adverse Events, Critical Population  42 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
1.  SUMMARY 
Leronlimab (PRO 140) has been studied in a Phase 2b/3, twoarm, randomized, doubleblind, placebocontrolled study to evaluate its safety and efficacy as addon therapy in patients being treated with institutional standard of care (SoC) for severe or critical symptoms of respiratory illness caused by coronavirus disease 2019 (COVID19).
394 subjects were randomized in a 2:1 ratio to leronlimab or placebo, in combination with SoC therapies. 384 subjects received at least one dose of the study medication (leronlimab 700 mg Or placebo administered subcutaneously on Day 0 and Day 7) and are included in the mITT analyses.
The study population includes 62 critically ill (Baseline Ordinal Score 2) and 322 noncritically ill (Baseline Ordinal Score 3 or higher) patients having confirmed diagnosis of COVID19 by standard RTPCR assay or equivalent testing.
Demographic and baseline characteristics showed a higher proportion of >65 years old [33% (88/259) vs 23% (29/125)] population were enrolled in the leronlimab + SoC group compared to placebo + SoC group. The mortality rate reported in the >65 years group is about 3.5 times higher compared to the £65 years group [42% (49/117) vs. 12% (31/267)] in the study. Therefore, additional analyses for the primary and major secondary endpoints were conducted to demonstrate the survival benefit of leronlimab in: age group > 65 years; age group £ 65 years; and adjusted for the age group (> 65 years and £ 65 years).
RESULTS:
The below table summarizes Day 28 allcause mortality for combined and subgroups by age:
Table 11: Effect of Randomization by Age on 28Day AllCause Mortality
Death/Randomized (%)  Absolute Reduction 
Relative Reduction  
Leronlimab  Placebo  
Day 28 Mortality, mITT 
53/259 (20.5%)  27/125 (21.6%)  1.1%  5.3%  
Day 28 Mortality, mITT, > 65y 
36/88 (40.9%)  13/29 (44.8%)  3.9%  8.7%  
Day 28 Mortality, mITT, £ 65y 
17/171 (9.9%)  14/96 (14.6%)  4.7%  31.8%  

•  Survival benefit: A favorable, statistically significant results (p value 0.0319) reported for the primary endpoint (allcause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID19 treatments” compared to participants who received “commonly used COVID19 treatments” alone in the placebo group in the overall mITT population. 
Similar statistically significant results (p value 0.0552) reported for the primary endpoint (allcause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment for COVID19, compared to patients who received dexamethasone (without leronlimab) as standard of care therapy in the overall mITT population.
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Death/Randomized (%)  P value  
Leronlimab  Placebo  
Day 28 Mortality, mITT, prior or concomitant COVID treatment 
34/205 (16.6%)  24/104 (23.1%)  0.0319  
Day 28 Mortality, mITT, prior or concomitant dexamethasone use 
25/155 (16.1%)  17/78 (21.8%)  0.0552  

Note: pvalue is from logistic model adjusted for stratification factor and age based on nonmissing observed data.
•  Shortened time to recovery: The average length of hospital stay was lower in leronlimab group compared to placebo/SoC group in the critically ill population with a statistically significant p value of 0.0050 using the RankANCOVA model. 
Days  P value  
Leronlimab  Placebo  
Mean Length of hospital stay (days), mITT, Baseline OS=2 
33.0  38.5  0.005  

Note: pvalue is from the rankANCOVA model adjusted for stratification factor and age
•  Leronlimab improved the probability of “discharged alive” at Day 28 in the overall mITT population as well as in the critically ill population with the results trending towards statistical significance. 
Responders/Randomized (%)  P value  
Leronlimab  Placebo  
OS 6 or higher, mITT Day 28 (responders)  No Imputation 
126/259 (48.6%)  54/125 (43.2%)  0.0697  
OS 6 or higher, mITT Day 28 (responders) Baseline OS=2 
12/43 (27.9%)  2/19 (10.5%)  0.0824  

Note: pvalue is from logistic model adjusted for stratification factor and age based on nonmissing observed data
•  Safety Analysis: 
The safety analysis of leronlimab in COVID19 patients was found consistent with the established extensive safety profile with over 1000 patients treated across other multiple studies and indications. Leronlimab in combination with other commonly used COVID19 treatments was welltolerated with no new safety signal detected in the CD12_COVID19 study. The overall incidence rate, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) were similar between the leronlimab + SoC and placebo + SoC groups in this study.
•  Conclusions: 
•  The potential benefit of adding leronlimab to SoC was consistently seen in the critically ill patient population by virtue of numerically better results for all prespecified evaluated clinical endpoints. 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
•  Adding leronlimab to the commonly used COVID19 treatments including dexamethasone reduced mortality compared to the commonly used treatments without leronlimab in the critically ill patient population and in the overall mITT population. 
•  Given these findings, there is a high likelihood that critically ill COVID19 patients may benefit from leronlimab added on to SoC treatments. Given the favorable safety profile of leronlimab, the current mortality rate, and the absolute number of deaths due to COVID19 in the USA and around the world, the availability of leronlimab for emergency use has the potential to save many lives. 
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1.1 SUMMARY FIGURES Figure 11: AllCause Mortality, Day 28 Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Figure 12: AllCause Mortality (Day 28), Prior and Concomitant COVID19 Treatment Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Figure 13: AllCause Mortality (Day 28), Prior and Concomitant Dexamethasone Use Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Figure 14: Ordinal Scale 6 or Higher (Discharged Alive) Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Figure 15: Change in Clinical Status of Subject at Day 28 (on a 7 point Ordinal Scale) Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Figure 16: Length of Hospital Stay (Days) Note: Data label on the inside end of bar in the parenthesis reflect number of subjects in the population/treatment group (N).
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
2.  INTRODUCTION 
2.1  DISEASE BACKGROUND 
COVID19 is a disease caused by a novel coronavirus that emerged in Wuhan, China, in December 2019. Other diseases caused by coronaviruses include severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and the common cold. COVID19 manifests as a respiratory illness of widely varying clinical severity. At the most severe end of the spectrum, it results in severe pneumonia and respiratory failure. Acute respiratory distress syndrome (ARDS) is often the preterminal event in patients with COVID19. Severe COVID19 is often associated with the release of proinflammatory cytokines, which may cause or exacerbate lung injury leading to lifethreatening disease.
2.2  LERONLIMAB (PRO 140) 
Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the CC chemokine receptor type 5 (CCR5). Leronlimab acts as a competitive inhibitor by binding the Nterminus and second extracellular loop and blocking CCR5mediated infection of cells. CCR5 is expressed predominantly on T cells but also found on macrophages, dendritic cells, and eosinophils to mediate chemotaxis in response to its cognate ligands that include CCL5 (RANTES), CCL3 (MIP1α), and CCL4 (MIP1ß). These ligands are integral in the recruitment of these immune cells to inflammatory sites. The immunopathogenesis of COVID19 likely involves the excessive influx of immune cells into the lung. SARSCoV1 has very similar clinical findings to COVID19 and elicits high levels of CCL5 expression by airway epithelial cells and macrophages. Disruption of the CCL5CCR5 axis via leronlimabmediated CCR5 blockade might prevent pulmonary trafficking of proinflammatory leukocytes and dampen pathogenic immune activation in COVID19.
The migration of macrophages and release of proinflammatory cytokines led to acute respiratory distress syndrome (ARDS) in lungs. The ARDS has known to be one of the main reasons for mortalities in patients with COVID19. CytoDyn believes that leronlimab, a CCR5 antagonist, is potentially therapeutic in inhibiting proinflammatory cytokines responses as observed in ARDS and could be useful in treating COVID19.
3.  STUDY OVERVIEW 
This study is a Phase 2b/3, twoarm, randomized, doubleblind, placebocontrolled, adaptive design study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus disease 2019 (COVID19). Approximately 390 subjects are to be randomized in a 2:1 ratio to leronlimab or placebo group. Leronlimab 700mg (175 mg/mL) and placebo were administered subcutaneously as an addon to the institutional standard of care treatment (SoC).
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
3.1  PATIENT POPULATION 
The study population includes critically ill and noncritically ill hospitalized patients with a confirmed diagnosis of COVID19 by standard RTPCR assay or equivalent testing.
Critical Illness:
Based on clinical severity on the baseline Ordinal Scale (OS) score of 2
OS 2 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Note: The patient, if intubated, must have positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg to enroll in the study.
Non Critical (Severe) Illness:
Based on clinical severity on the baseline Ordinal Scale (OS) score of 3 or 4
OS 3 = Hospitalized, on noninvasive ventilation or high flow oxygen devices.
OS 4 = Hospitalized, requiring supplemental oxygen.
The study allowed coadministration of approved or offlabel COVID19 treatments as part of standardofcare therapies.
3.2  ENDPOINTS 
The primary endpoint and major secondary endpoints (at Day 28) are presented in this Executive Summary.
•  Primary Endpoint: 
•  Allcause mortality at Day 28 
•  Major Secondary Endpoints: 
•  Proportion of patients achieving a category of 6 or higher at Day 28 (on a 7 point ordinal scale). 
•  Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) 
Note: A 7category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on noninvasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
•  Length of hospital stay (days). 
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Note: Subgroup analyses were conducted based on baseline Ordinal Scale (OS) for patient severity (OS 2 = Critically ill; OS 3&4 = NonCritically ill) for the primary and major secondary endpoints listed above.
3.3  ANALYSIS POPULATION 
A summary of the analysis populations is provided in Table 41.
A total of 394 subjects were randomized and thus included in the IntenttoTreat (ITT) population.
Of those, 384 (97.5%) subjects who received at least one dose of study treatment (leronlimab or placebo) were included in the Modified IntenttoTreat (mITT) and Safety population. The demographics summaries for the mITT population is provided in Table 42. Demographic and baseline characteristics were generally balanced except for a slightly higher proportion of nonwhite (50% vs 44%), and >65 years old (33% vs 23%) population in the Leronlimab + SoC group. Both of these groups of COVID19 patients are known to have higher mortality rates.
Among the 384 participants, 62 (16%) subjects are categorized under critically ill population based on an ordinal scale score of 2 at baseline, i.e. patients hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), as described in Section 3.1.
As defined in the statistical analysis plan, the Modified IntenttoTreat (mITT) Population is used to analyze the primary and secondary efficacy endpoints and Safety Population is used for the analysis of safety parameters or measurements.
3.3.1  Subgroup analysis  Age group 
Demographic and baseline characteristics showed a higher proportion of >65 years old [34% (88/259) vs 23% (29/125)] population were enrolled in the leronlimab + SoC group compared to placebo + SoC group. The mortality rate reported in the >65 years group is about 3.5 times higher compared to the £65 years group [42% (49/117) vs. 12% (31/267)] in the study. Therefore, additional analyses for the primary and major secondary endpoints were conducted to demonstrate the survival benefit of leronlimab in:
a.  Age group > 65 years 
b.  Age group £ 65 years; and 
c.  Adjusted for the age group (> 65 years and £ 65 years) 
3.4  RESULTS DESCRIPTION 
A total of 384 subjects randomized and treated (mITT), 259 in leronlimab and 125 in placebo group.
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
3.4.1 Primary endpoint (Allcause mortality at Day 28)
Overall population:
The survival benefit of adding leronlimab to SoC was evident in both > 65 years and £ 65 years age group within overall mITT population.
> 65 years: Allcause mortality among > 65 years age group was 41% (36 out of 88 subjects died) within 28 days of treatment initiation in leronlimab + SoC group compared to 45% (13 out of 29 subjects died) in placebo + SoC group (Table 44). This is approximately a 9% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone.
£ 65 years: Allcause mortality among £ 65 years age group was 10% (17 out of 171 subjects died) within 28 days of treatment initiation in leronlimab + SoC group compared to 15% (14 out of 96 subjects died) in placebo + SoC group (Table 45). This is approximately a 32% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone.
Critical population:
Out of 62 patients in the critically ill population, 19 (31%) died within 28 days. Leronlimab showed a survival benefit in critically ill COVID19 patients. Allcause mortality among critically ill patients was 28% (12/43) with leronlimab + SoC and 37% (7/19) with placebo + SoC at day 28 (Table 46). This is approximately a 24% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the critically ill population.
> 65 years: Allcause mortality among > 65 years age group was 64% (9/14) within 28 days of treatment initiation in leronlimab + SoC group compared to 75% (3/4) in placebo + SoC group (Table 47). This is approximately a 14% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in > 65 years age group in critically ill population.
£ 65 years: Allcause mortality among £ 65 years age group was 10% (3/29) within 28 days of treatment initiation in leronlimab + SoC group compared to 27% (4/15) in placebo + SoC group (Table 48). This is approximately a 61% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in £ 65 years age group in the critically ill population.
3.4.2 Primary endpoint (Allcause mortality at Day 28) – Additional Analyses
3.4.2.1 Leronlimab + specific COVID19 treatments vs. specific COVID19 treatments alone
The study allowed prior and coadministration of any approved or offlabel COVID19 treatments as the standard of care therapies. Hence, subgroup analyses were performed to evaluate the treatment effect of leronlimab in subjects receiving these commonly used COVID19 treatments. For the purpose of subgroup analyses, the following medications were considered “commonly used treatment for COVID19: hydroxychloroquine or chloroquine with or without azithromycin,
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
remdesivir, dexamethasone (or other corticosteroids), monoclonal antibodies (such as bamlanivimab, casirivimab, imdevimab, siltuximab), immunomodulatory agents (such as baricitinib, sarilumab, clazakizumab, tocilizumab, anakinra), and convalescent plasma therapy. Approximately 80% of the participants received these medications (309/384). Leronlimab, when added on these “commonly used treatment”, seems to provide additional survival benefit at Day 28. Mortality rate was 17% (34/205) in subjects receiving leronlimab + “commonly used treatment” compared to 23% (24/104) in subjects who received “commonly used treatments” alone in the placebo group in the overall mITT population, a relative reduction in mortality by approximately 28%. This was statistically significant with p value of 0.0319 using the logit model. (Table 49)
> 65 years: Allcause mortality rate was 40% (25/62) in subjects receiving leronlimab + “commonly used treatment” compared to 46% (12/26) in subjects who received placebo + “commonly used treatments” in the > 65 years age group of overall mITT population, a relative reduction of approximately 13%. (Table 410)
£ 65 years: Allcause mortality rate was 6% (9/143) in subjects receiving leronlimab + “commonly used treatment” compared to 15% (12/78) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of overall mITT population, a relative reduction of approximately 59%. (Table 411)
Critical population:
Majority of the critically ill patients received these medications (54/62). Mortality rate was 25% (9/36) in subjects receiving leronlimab + “commonly used treatment” compared to 39% (7/18) in subjects who received “commonly used treatments” alone in the placebo group in the critically ill population. This is approximately a 36% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the critically ill population. (Table 412)
> 65 years: Allcause mortality rate was 70% (7/10) in subjects receiving leronlimab + “commonly used treatment” compared to 75% (3/4) in subjects who received placebo + “commonly used treatments” in the > 65 years age group of critically ill population. This is approximately a 7% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the > 65 years age group of critically ill population. (Table 413)
£ 65 years: Allcause mortality rate was 8% (2/26) in subjects receiving leronlimab + “commonly used treatment” compared to 29% (4/14) in subjects who received placebo + “commonly used treatments” in the £ 65 years age group of critically ill population. This is approximately a 73% relative reduction in mortality observed with leronlimab when given in combination with other SoC therapies compared to SoC alone in the £ 65 years age group of critically ill population. (Table 414)
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
3.4.2.2 Leronlimab + Dexamethasone vs. Dexamethasone alone
Approximately 60% of the participants (233/384) received dexamethasone, a systemic corticosteroid. Among participants who received dexamethasone as the prior or concomitant standard of care treatment for COVID19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as standard of care therapy [16% (25/155) vs 22% (17/78)] in the overall mITT population. This is approximately a 26% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone. (Table 415). The p value of 0.0552 using the logit model.
> 65 years: Among participants in > 65 years age group who received dexamethasone as prior or concomitant SoC treatment for COVID19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as SoC therapy [35% (19/54) vs 45% (10/22)] in the overall mITT population. This is approximately a 23% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone in > 65 years age group of the overall mITT population. (Table 416)
£ 65 years: Among participants in £ 65 years age group who received dexamethasone as prior or concomitant SoC treatment for COVID19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as SoC therapy [6% (6/101) vs 13% (7/56)] in the overall mITT population. This is approximately a 53% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone in £ 65 years age group of the overall mITT population. (Table 417)
Critical population:
Among critically ill participants who received dexamethasone as prior or concomitant SoC treatment for COVID19, the mortality rate within 28 days was lower in leronlimab group (leronlimab + dexamethasone) compared to patients who received dexamethasone (without leronlimab) as SoC therapy [21% (5/24) vs 27% (3/11)]. This is approximately a 24% relative reduction in mortality observed with leronlimab when given in combination with dexamethasone compared to dexamethasone alone in the critically ill population. (Table 418)
3.4.3 Patients achieving OS 6 or higher (Discharged alive)
Overall population:
Evaluation of the clinical status at Day 28 was assessed with a 7level ordinal scale (with higher score indicating better outcome). The study enrolled hospitalized patients with an ordinal scale (OS) Score of 2, 3, or 4 at baseline. The OS score of 6 refers to participant who is not hospitalized with limitation on activities and 7 refers to not hospitalized with no limitations on activities.
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Leronlimab improved the probability of “discharged alive” at Day 28, to 49% (126/259) from 43% (54/125) in the placebo + SoC group, a relative improvement of approximately 13% among hospitalized patients of varying severity at baseline (from those needing supplemental oxygen to those requiring intubation) with a pvalue of 0.0697 using the logit model. (Table 419A). The results of an additional analysis using multiple imputation for missing data are presented in Table 419B.
> 65 years: A numerically higher proportion of patients were discharged from hospital alive in the leronlimab + SoC (32%) vs placebo + SoC (21%) in > 65 years age group. (Table 420A). This is approximately a 54% relative improvement or higher probability of discharged alive from hospital with leronlimab group compared to placebo (SoC alone) group. The results of an additional analysis using multiple imputation for missing data is presented in Table 420B.
£ 65 years: A numerically higher proportion of patients were discharged from hospital alive in the leronlimab + SoC (57%) vs placebo + SoC (50%) in £ 65 years age group. (Table 421A). This is approximately a 15% relative improvement or higher probability of discharged alive from hospital with leronlimab group compared to placebo (SoC alone) group. The results of an additional analysis using multiple imputation for missing data are presented in Table 421B.
Critical population:
28% (12/43) of the criticallyill population (i.e., on invasive mechanical ventilation/intubated at baseline) who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 11% (2/19) patients in the placebo + SoC group (Table 422), a relative improvement of approximately 166% in the proportion of patients discharged within 28 days in leronlimab group compared to SoC alone (Pvalue of 0.0824)
> 65 years: 21% (3/14) of the criticallyill population in > 65 years age group who received leronlimab + SoC were discharged from the hospital within 28 days compared to none 0% (0/4) of the patients in the placebo + SoC group (Table 423).
£ 65 years: 31% (9/29) of the criticallyill population in £ 65 years age group who received leronlimab + SoC were discharged from the hospital within 28 days compared to only 13% (2/15) of the patients in the placebo + SoC group (Table 424). This is a relative improvement of approximately 133% in participants who received leronlimab compared to the placebo group.
3.4.4 Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)
Overall population:
The improvement in clinical status according to the ordinal scale score at Day 28 was higher in the leronlimab + SoC group compared to the placebo + SoC group. The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+1.5) in leronlimab + SoC group compared to (+1.2) in the placebo + SoC group (Table 425A). The results of an additional analysis using multiple imputation for missing data is presented in Table 425B.
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
> 65 years: The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+0.2) in leronlimab + SoC group compared to (0.0) in the placebo + SoC group in > 65 years age group (Table 426A). The results of an additional analysis using multiple imputation for missing data are presented in Table 426B.
£ 65 years: The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+2.1) in leronlimab + SoC group compared to (+1.7) in the placebo + SoC group in £ 65 years age group (Table 427A). The results of an additional analysis using multiple imputation for missing data are presented in Table 427B.
Critical population:
The improvement in clinical status according to the ordinal scale score at Day 28 was higher in the leronlimab + SoC group compared to the placebo + SoC group. The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+1.4) in leronlimab + SoC group compared to only (+0.6) in the placebo + SoC group in the critically ill population. (Table 428)
> 65 years: The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+0.2) in leronlimab + SoC group compared to mean change (worsening) reported (0.3) in the placebo + SoC group in the > 65 years age group of critically ill population. (Table 429)
£ 65 years: The mean change (improvement) in the ranking on an ordinal scale from baseline to Day 28 was (+2.1) in leronlimab + SoC group compared to only (+0.9) in the placebo + SoC group in the £ 65 years age group of critically ill population. (Table 430)
3.4.5 Length of hospital stay (days)
Overall population:
The average length of hospital stay was similar between the two treatment groups in the overall mITT population (21.4 days). (Table 431)
> 65 years: The average length of hospital stay was lower in leronlimab + SoC group (28 days) compared to the placebo + SoC group (31 days) in the > 65 years age group of overall mITT population. (Table 432)
£ 65 years: The average length of hospital stay was lower in leronlimab + SoC group (18 days) compared to the placebo + SoC group (19 days) in the £ 65 years age group of overall mITT population. (Table 433)
Critical population:
The average length of hospital stay was lower in leronlimab + SoC group (33 days) compared to the placebo + SoC group (39 days) in the critically ill population. This was statistically significant with p value of 0.0050 using the RankANCOVA model. (Table 434)
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Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
> 65 years: The average length of hospital stay was lower in leronlimab + SoC group (37 days) compared to the placebo + SoC group (42 days) in the > 65 years age group of critically ill population. (Table 435)
£ 65 years: The average length of hospital stay was lower in leronlimab + SoC group (31 days) compared to the placebo + SoC group (38 days) in the £ 65 years age group of critically ill population. (Table 436)
3.5  SAFETY ANALYSIS 
Leronlimab has an extensive safety profile available based on data from more than 1000 patients treated across multiple studies and indications. Leronlimab was generally well tolerated with no major safety concerns. Participants have received weekly subcutaneous doses of leronlimab with the longest duration of exposure lasting 5+ years in HIV setting.
The overall incidence rate, frequency, and severity of adverse events and serious adverse events (SAEs) were similar between the leronlimab and placebo group in the CD12_COVID19 study.
An overview of all adverse events and serious adverse events (SAEs) reported in the study at the time of the data snapshot is provided in Table 437. There were 197 SAEs reported for 99 subjects (38.2%, 99/259) in the leronlimab (PRO 140) group and 98 SAEs reported for 47 subjects (37.6%, 47/125) in the placebo group. Additionally, an overview of all adverse events and serious adverse events (SAEs) reported in the critically ill population is provided in Table 438.
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4.  SUMMARY TABLES 
Table 41: Analysis Population, All Subjects
Parameter 
Leronlimab 700 mg N=265 n(%) 
Placebo N=129 n(%) 
Total N=394 n(%)  
Intent to Treat (ITT) population 
265 (100.0)  129 (100.0)  394 (100.0)  
ModifiedIntent to Treat (mITT) population 
259 (97.7)  125 (96.9)  384 (97.5)  
Safety population 
259 (97.7)  125 (96.9)  384 (97.5) 
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Table 42: Summary of Demographics, mITT Population
Parameter 
Characteristic 
Leronlimab 700 mg N=259 
Placebo N=125 
Total N=384  
Gender 
Male, n(%)  169 (63.8)  83 (64.3)  252 (64.0)  
Female, n(%)  90 (34.0)  42 (32.6)  132 (33.5)  
American Indian/Alaskan Native, n(%)  1 (0.4)  0 (0.0)  1 (0.3)  
Asian, n(%)  11 (4.2)  7 (5.4)  18 (4.6)  
Race 
Black/AfricanAmerican, n(%)  29 (10.9)  23 (17.8)  52 (13.2)  
White, n(%)  133 (50.2)  70 (54.3)  203 (51.5)  
Other, n(%)  85 (32.1)  25 (19.4)  110 (27.9)  
Not Hispanic/Latino, n(%)  122 (46.0)  72 (55.8)  194 (49.2)  
Ethnicity 
Hispanic/Latino, n(%)  123 (46.4)  52 (40.3)  175 (44.4)  
Not Reported, n(%)  8 (3.0)  0 (0.0)  8 (2.0)  
Unknown, n(%)  6 (2.3)  1 (0.8)  7 (1.8)  
Age (Years) [1] 
n  259  125  384  
Mean (SD)  58.82 (13.82) 
58.51 (11.50) 
58.72 (13.09)  
Median  59  58  59  
Min  Max  2088  2886  2088  
< 40  26 (9.8)  8 (6.2)  34 (8.6)  
Age Group 
4065  145 (54.7)  88 (68.2)  233 (59.1)  
> 65  88 (33.2)  29 (22.5)  117 (29.7) 
[1] Age (Years) = Integer of [(date of informed consent  date of birth) / 365.25]
Note: All percentages are based on the number of subjects in the population and treatment group (N).
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Table 43: Mortality Status at Day 28, mITT Population
Category 
Leronlimab 700 mg N=259 
Placebo N=125 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
53 (20.46%)  27(21.60%)  0.70  (0.39, 1.25) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 44: Mortality Status at Day 28, > 65 years, mITT Population
Category 
Leronlimab 700 mg N=88 
Placebo N=29 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
36 (40.91%)  13 (44.83%)  0.79  (0.32, 1.93) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 45: Mortality Status at Day 28, £ 65 years, mITT Population
Category 
Leronlimab 700 mg N=171 
Placebo N=96 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
17 (9.94%)  14 (14.58%)  0.64  (0.30, 1.37) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
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Table 46: Mortality Status at Day 28  Ordinal Scale 2 at Baseline, mITT population
Category 
Leronlimab 700 mg N=43 
Placebo N=19 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
12 (27.91%)  7 (36.84%)  0.43  (0.10, 1.82) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 47: Mortality Status at Day 28  Ordinal Scale 2 at Baseline, > 65 years, mITT population
Category 
Leronlimab 700 mg N=14 
Placebo N=4 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
9 (64.29%)  3 (75.00%)  1.00  (0.06,15.99) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 48: Mortality Status at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, mITT population
Category 
Leronlimab 700 mg N=29 
Placebo N=15 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
3 (10.34%)  4 (26.67%)  0.32  (0.06, 1.74) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
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Table 49: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, mITT Population
Category 
Leronlimab 700 mg N=205 
Placebo N=104 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
34 (16.59%)  24 (23.08%)  0.48  (0.25, 0.94) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: Commonly used COVID19 treatment includes hydroxychloroquine or chloroquine with or without azithromycin, antiviral agents (remdesivir), dexamethasone (or other corticosteroids), monoclonal antibodies (such as bamlanivimab, casirivimab, imdevimab, siltuximab), immunomodulatory agents (such as baricitinib, sarilumab, clazakizumab, tocilizumab, anakinra), and convalescent plasma therapy.
Table 410: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, > 65 years, mITT Population
Category 
Leronlimab 700 mg N=62 
Placebo N=26 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
25 (40.32%)  12 (46.15%)  0.69  (0.26, 1.85) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: Commonly used COVID19 treatment includes hydroxychloroquine or chloroquine with or without azithromycin, antiviral agents (remdesivir), dexamethasone (or other corticosteroids), monoclonal antibodies (such as bamlanivimab, casirivimab, imdevimab, siltuximab), immunomodulatory agents (such as baricitinib, sarilumab, clazakizumab, tocilizumab, anakinra), and convalescent plasma therapy.
Table 411: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments, £ 65 years, mITT Population
Category 
Leronlimab 700 mg N=143 
Placebo N=78 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
9 (6.29%)  12 (15.38%)  0.34  (0.14, 0.87) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Note: Commonly used COVID19 treatment includes hydroxychloroquine or chloroquine with or without azithromycin, antiviral agents (remdesivir), dexamethasone (or other corticosteroids), monoclonal antibodies (such as bamlanivimab, casirivimab, imdevimab, siltuximab), immunomodulatory agents (such as baricitinib, sarilumab, clazakizumab, tocilizumab, anakinra), and convalescent plasma therapy.
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Table 412: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, mITT Population
Category 
Leronlimab 700 mg N=36 
Placebo N=18 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
9 (25.00%)  7 (38.89%)  0.33  (0.07, 1.62) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Table 413: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, > 65 years, mITT Population
Category 
Leronlimab 700 mg N=10 
Placebo N=4 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
7 (70.00%)  3 (75.00%)  1.06  (0.06,17.55) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Table 414: Mortality Status at Day 28  with Prior or Concomitant COVID19 Treatments  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population
Category 
Leronlimab 700 mg N=26 
Placebo N=14 
Odds Ratio  95% CI  
Subject Deceased, n (%) 
2 (7.69%)  4 (28.57%)  0.20  (0.03, 1.37) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
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Table 415: Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, mITT Population
Category 
Leronlimab 700 mg N=155 
Placebo N=78 
Odds Ratio  95% CI  
Subject Deceased, n(%) 
25 (16.13%)  17 (21.79%)  0.47  (0.21, 1.02) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Table 416: Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, > 65 years, mITT Population
Category 
Leronlimab 700 mg N=54 
Placebo N=22 
Odds Ratio  95% CI  
Subject Deceased, n(%) 
19 (35.19%)  10 (45.45%)  0.48  (0.16, 1.44) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Table 417: Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use, £ 65 years, mITT Population
Category 
Leronlimab 700 mg N=101 
Placebo N=56 
Odds Ratio  95% CI  
Subject Deceased, n(%) 
6 (5.94%)  7 (12.50%)  0.40  (0.13, 1.27) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects in the population and treatment group (N).
Table 418: Mortality Status at Day 28  with Prior or Concomitant Dexamethasone Use  Ordinal Scale 2 at Baseline, mITT Population
Category 
Leronlimab 700 mg N=24 
Placebo N=11 
Odds Ratio  95% CI  
Subject Deceased, n(%) 
5 (20.83%)  3 (27.27%)  0.34  (0.04, 2.60) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
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Table 419: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, mITT Population
(A) No Imputation, Missing as Missing
Visit 
Statistic 
Leronlimab 700 mg N=259 
Placebo N=125 
Odds Ratio  95% CI  
Responders, n (%) 
126 (48.6%)  54 (43.2%)  1.617  (0.96, 2.72  )  
Day 28 
NonResponders, n (%) 
94 (36.3%)  52 (41.6%)  
Missing, n (%) 
39 (15.1%)  19 (15.2%) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
(B) Multiple Imputation
Visit 
Statistic 
Leronlimab 700 mg N=259 
Placebo N=125 
Odds Ratio  95% CI  
Day 28 
Responders, n (%) 
58.92%  54.88%  1.47  (0.89, 2.42)  
NonResponders, n (%) 
41.08%  45.12% 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
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Table 420: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, > 65 years, mITT Population
(A) No Imputation, Missing as Missing
Visit 
Statistic 
Leronlimab 700 mg N=88 
Placebo N=29 
Odds Ratio  95% CI  
Responders, n (%) 
28 (31.8%)  6 (20.7%)  1.981  ( 0.71, 5.55)  
Day 28 
NonResponders, n (%) 
49 (55.7%)  21 (72.4%)  
Missing, n (%) 
11 (12.5%)  2 (6.9%) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
(B) Multiple Imputation
Visit 
Statistic 
Leronlimab 700 mg N=88 
Placebo N=29 
Odds Ratio  95% CI  
Day 28 
Responders, n (%) 
39.32%  26.21%  1.80  ( 0.65, 4.97)  
NonResponders, n (%)  60.68%  73.79% 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
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Table 421: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28, £ 65 years, mITT Population
(A) No Imputation, Missing as Missing
Visit 
Statistic 
Leronlimab 700 mg N=171 
Placebo N=96 
Odds Ratio  95% CI  
Responders, n (%) 
98 (57.3%)  48 (50.0%)  1.554  ( 0.84, 2.89)  
Day 28 
NonResponders, n (%) 
45 (26.3%)  31 (32.3%)  
Missing, n (%) 
28 (16.4%)  17 (17.7%) 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
(B) Multiple Imputation
Visit 
Statistic 
Leronlimab 700 mg N=171 
Placebo N=96 
Odds Ratio  95% CI  
Day 28 
Responders, n (%) 
69.12%  64.79%  1.32  ( 0.74, 2.36)  
NonResponders, n (%) 
30.88%  35.21% 
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects in the population and treatment group (N).
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Table 422: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, mITT Population
Visit 
Statistic 
Leronlimab 700 mg N=43 
Placebo N=19 
Odds Ratio  95% CI  
Responders, n (%) 
12 (27.9%)  2 (10.5%)  4.425  ( 0.83,23.70)  
Day 28 
NonResponders, n (%) 
27 (62.8%)  16 (84.2%)  
Missing, n (%) 
4 (9.3%)  1 (5.3%) 
Note: Logistic model adjusted for stratification factor and age based on nonmissing observed data
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 423: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, > 65 years, mITT Population
Visit 
Statistic  Leronlimab 700 mg N=14 
Placebo N=4 
Odds Ratio  95% CI  
Day 28 
Responders, n (%)  3 (21.4%)  NA  NA  
NonResponders, n (%)  11 (78.6%)  4 (100%) 
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
Table 424: Proportion of Subjects Achieving a Category of 6 or Higher on the Ordinal Scale at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population
Visit 
Statistic 
Leronlimab 700 mg N=29 
Placebo N=15 
Odds Ratio  95% CI  
Responders, n (%) 
9 (31.0%)  2 (13.3%)  4.092  ( 0.69,24.32)  
Day 28 
NonResponders, n (%) 
16 (55.2%)  12 (80.0%)  
Missing, n (%) 
4 (13.8%)  1 (6.7%) 
Note: Responders refer to subjects who achieved a category of 6 or higher at Day 28.
Note: Logistic model adjusted for stratification factor based on nonmissing observed data
Note: All percentages are based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
Note: No imputation performed for missing data less than 10%.
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Table 425: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, mITT Population
(A)  No Imputation, Missing as Missing 
Leronlimab 700 mg N=259 
Placebo N=125  
Visit 
Statistic  Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
n  259  125  
Mean (SD)  3.2 (0.68)  3.2 (0.70)  
Baseline 
Median  3  3  
MinMax  2.0  4.0  2.0  5.0  
n  220  220  106  106  
Mean (SD)  4.6 (2.49)  1.5 (2.36)  4.4 (2.46)  1.2 (2.27)  
Day 28 
Median  6  3  6  2  
MinMax  1.0  7.0  3.0  5.0  1.0  7.0  3.0  4.0 
Note: Rank ANCOVA model adjusted for stratification factor and age based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
(B) Multiple Imputation, Rank ANCOVA Method
Leronlimab 700 mg  Placebo  
N=259  N=125  
Visit 
Statistic  Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
n  259  125  
Mean (SD)  3.2 (0.68)  3.2 (0.70)  
Baseline 
Median  3  3  
MinMax  2.0  4.0  2.0  5.0  
n  259  259  125  125  
Mean (SD)  4.7 (2.35)  1.5 (2.25)  4.6 (2.37)  1.4 (2.18)  
Day 28 
Median  6.0  2.0  6.0  2.0  
MinMax  1.0  7.0  3.0  5.0  1.0  7.0  3.0  4.2 
Note: Rank ANCOVA model adjusted for stratification factor and age based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
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Table 426: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, > 65 years, mITT Population
(A) No Imputation, Missing as Missing
Leronlimab 700 mg  Placebo  
N=88  N=29  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  88  29  
Mean (SD)  3.2 (0.68)  3.1 (0.62)  
Baseline 
Median  3.0  3.0  
MinMax  2.0  4.0  2.0  4.0  
n  77  77  27  27  
Mean (SD)  3.3 (2.57)  0.2 (2.46)  3.1 (2.30)  0.0 (2.34)  
Day 28 
Median  2.0  1.0  2.0  1.0  
MinMax  1.0  7.0  3.0  4.0  1.0  7.0  3.0  4.0 
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
(B) Multiple Imputation, Rank ANCOVA Method
Leronlimab 700 mg  Placebo  
N=88  N=29  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  88  29  
Mean (SD)  3.2 (0.68)  3.1 (0.62)  
Baseline 
Median  3.0  3.0  
MinMax  2.0  4.0  2.0  4.0  
n  88  88  29  29  
Mean (SD)  3.6 (2.50)  0.4 (2.37)  3.3 (2.35)  0.2 (2.40)  
Day 28 
Median  3.3  0.0  4.0  1.0  
MinMax  1.0  7.0  3.0  4.0  1.0  7.0  3.0  4.0 
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
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Table 427: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Rank ANCOVA, £ 65 years, mITT Population
(A)  No Imputation, Missing as Missing 
Leronlimab 700 mg  Placebo  
N=171  N=96  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  171  96  
Mean (SD)  3.2 (0.69)  3.3 (0.73)  
Baseline 
Median  3.0  3.0  
MinMax  2.0  4.0  2.0  5.0  
n  143  143  79  79  
Mean (SD)  5.2 (2.18)  2.1 (2.02)  4.9 (2.36)  1.7 (2.09)  
Day 28 
Median  6.0  3.0  6.0  3.0  
MinMax  1.0  7.0  3.0  5.0  1.0  7.0  3.0  4.0 
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
(B) Multiple Imputation, Rank ANCOVA Method
Leronlimab 700 mg  Placebo  
N=171  N=96  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  171  96  
Mean (SD)  3.2 (0.69)  3.3 (0.73)  
Baseline 
Median  3.0  3.0  
MinMax  2.0  4.0  2.0  5.0  
n  171  171  96  96  
Mean (SD)  5.3 (2.05)  2.1 (1.92)  5.1 (2.24)  1.8 (1.99)  
Day 28 
Median  6.0  3.0  6.0  2.9  
MinMax  1.0  7.0  3.0  5.0  1.0  7.0  3.0  4.6 
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
Confidential  Page 37 of 42 
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 428: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, Rank ANCOVA, mITT Population
Leronlimab 700 mg  Placebo  
N=43  N=19  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  43  19  
Mean (SD)  2.0 (0.00)  2.0 (0.00)  
Baseline 
Median  2.0  2.0  
MinMax  2.0 – 2.0  2.0 – 2.0  
n  39  39  18  18  
Mean (SD)  3.4 (2.29)  1.4 (2.29)  2.6 (1.75)  0.6 (1.75)  
Day 28 
Median  2.0  0.0  2.0  0.0  
MinMax  1.0  7.0  1.0  5.0  1.0  6.0  1.0  4.0 
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
Note: Rank ANCOVA model adjusted for stratification factor and age based on nonmissing observed data
Note: No imputation performed for missing data less than 10%.
Table 429: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, > 65 years, Rank ANCOVA, mITT Population
Leronlimab 700 mg  Placebo  
N=14  N=4  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  14  4  
Mean (SD)  2.0 (0.00)  2.0 (0.00)  
Baseline 
Median  2.0  2.0  
MinMax  2.0  2.0  2.0  2.0  
n  14  14  4  4  
Mean (SD)  2.2 (2.08)  0.2 (2.08)  1.8 (1.50)  0.3 (1.50)  
Day 28 
Median  1.0  1.0  1.0  1.0  
MinMax  1.0  6.0  1.0  4.0  1.0  4.0  1.0  2.0 
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
Note: No imputation performed for missing data less than 10%.
Confidential  Page 38 of 42 
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 430: Summary of Change in Clinical Status (on a 7 point ordinal scale) at Day 28  Ordinal Scale 2 at Baseline, £ 65 years, Rank ANCOVA, mITT Population
Leronlimab 700 mg  Placebo  
N=29  N=15  
Result  Change from Baseline [1] 
Result  Change from Baseline [1]  
Visit 
Statistic  
n  29  15  
Mean (SD)  2.0 (0.00)  2.0 (0.00)  
Baseline 
Median  2.0  2.0  
MinMax  2.0  2.0  2.0  2.0  
n  25  25  14  14  
Mean (SD)  4.1 (2.15)  2.1 (2.15)  2.9 (1.79)  0.9 (1.79)  
Day 28 
Median  4.0  2.0  2.5  0.5  
MinMax  1.0  7.0  1.0  5.0  1.0  6.0  1.0  4.0 
[1] Baseline is the last available value before treatment. Change from baseline is based on patients with paired values.
Note: Rank ANCOVA model adjusted for stratification factor based on nonmissing observed data
Note: No imputation performed for missing data less than 10%.
Confidential  Page 39 of 42 
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 431: Summary of Length of Hospital Stay (Days), mITT Population
Leronlimab 700 mg  Placebo  PValue [1]  
Category 
Statistic 
N=259  N=125  
n  259  125  
Length of Hospital Stay (Days) 
Mean (SD)  21.4 (15.9)  21.4 (16.3)  
Median  15.0  14.0  0.2733  
MinMax  1.0  45.0  1.0  46.0 
Note: Based on the number of subjects in the mITT population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor and age.
Note: No imputation performed for missing data less than 10%.
Table 432: Summary of Length of Hospital Stay (Days), > 65 years, mITT Population
Leronlimab 700 mg  Placebo  PValue [1]  
Category 
Statistic 
N=88  N=29  
n  88  29  
Length of Hospital Stay (Days) 
Mean (SD)  28.0 (15.9)  31.1 (14.6)  
Median  41.0  42.0  0.3266  
MinMax  2.0  43.0  6.0  43.0 
Note: Based on the number of subjects in the mITT population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.
Table 433: Summary of Length of Hospital Stay (Days), £ 65 years, mITT Population
Leronlimab 700 mg  Placebo  PValue [1]  
Category 
Statistic 
N=171  N=96  
n  171  96  
Length of Hospital Stay (Days) 
Mean (SD)  18.0 (14.8)  18.4 (15.7)  
Median  11.0  11.0  0.5868  
MinMax  1.0  45.0  1.0  46.0 
Note: Based on the number of subjects in the mITT population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.
Confidential  Page 40 of 42 
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 434: Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, mITT Population
Category 
Statistic  Leronlimab 700 mg N=43 
Placebo N=19 
PValue [1]  
n  43  19  
Length of Hospital Stay (Days) 
Mean (SD)  33.0 (10.7)  38.5 (7.60)  
Median  40.0  42.0  0.0050  
MinMax  9.0  45.0  20.0  46.0 
Note: Based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor and age.
Note: No imputation performed for missing data less than 10%.
Table 435: Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, > 65 years, mITT Population
Category 
Statistic  Leronlimab 700 mg N=14 
Placebo N=4 
PValue [1]  
n  14  4  
Length of Hospital Stay (Days) 
Mean (SD)  37.1 (10.0)  41.8 (0.50)  
Median  42.0  42.0  0.9806  
MinMax  10.0  42.0  41.0  42.0 
Note: Based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.
Table 436: Summary of Length of Hospital Stay (Days)  Ordinal Scale 2 at Baseline, £ 65 years, mITT Population
Category 
Statistic  Leronlimab 700 mg N=29 
Placebo N=15 
PValue [1]  
n  29  15  
Length of Hospital Stay (Days) 
Mean (SD)  30.9 (10.6)  37.7 (8.39)  
Median  30.0  42.0  0.0060  
MinMax  9.0  45.0  20.0  46.0 
Note: Based on the number of subjects with Ordinal Scale of 2 at Baseline in the population and treatment group (N).
[1] pvalue is from the rankANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.
Confidential  Page 41 of 42 
Leronlimab (PRO 140) CD12_COVID19 Executive Summary 
Table 437: Overview of Adverse Events, Safety Population
Leronlimab 700 mg  Placebo  
Parameter 
N=259 n(%) 
Events  N=125 n(%) 
Events  
Subjects with ³ 1 AE 
142 (54.8)  555  77 (61.6)  337  
Subjects with ³ 1 SAE 
99 (38.2)  197  47 (37.6)  98  
By Severity 

Subjects with ³ 1 AE Leading to Death 
59 (22.8)  59  31 (24.8)  31  
Subjects with ³ 1 LifeThreatening AE 
17 (6.6)  83  8 (6.4)  41  
Subjects with ³ 1 Severe AE 
24 (9.3)  158  11 (8.8)  93  
By Causality 

Subjects with ³ 1 Probably Related AE 
1 (0.4)  1  0 (0.0)  0  
Subjects with ³ 1 Possibly Related AE 
8 (3.1)  8  9 (7.2)  16  
By Outcome 

Subjects with ³ 1 AE Leading to Drug Withdrawal 
1 (0.4)  1  1 (0.8)  1 
Note: All percentages are based on the number of subjects in the safety population and treatment group (N).
Note: A subject is counted only once within each category, using the event with the worstcase intensity (by severity) or relationship (by causality).
Table 438: Overview of Adverse Events, Critical Population
Leronlimab 700 mg  Placebo  
Parameter 
N=43 n(%) 
Events  N=19 n(%) 
Events  
Subjects with ³ 1 AE 
34 (79.1)  186  15 (78.9)  96  
Subjects with ³ 1 SAE 
24 (55.8)  43  14 (73.7)  30  
AEs By Severity 

Subjects with ³ 1 AE Leading to Death 
12 (27.9)  12  9 (47.4)  9  
Subjects with ³ 1 LifeThreatening AE 
10 (23.3)  23  2 (10.5)  8  
Subjects with ³ 1 Severe AE 
4 (9.3)  55  3 (15.8)  39  
Subjects with ³ 1 Moderate AE 
5 (11.6)  62  1 (5.3)  25  
Subjects with ³ 1 Mild AE 
3 (7.0)  34  0 (0.0)  15  
AEs By Causality 

Subjects with ³ 1 Possibly Related AE 
3 (7.0)  3  1 (5.3)  3  
Subjects with ³ 1 Remotely Related AE 
0 (0.0)  9  0 (0.0)  0  
Subjects with ³ 1 Unrelated AE 
31 (72.1)  174  14 (73.7)  93  
AEs By Outcome 

Subjects with ³ 1 AE That Led To Study Treatment Discontinuation 
0 (0.0)  0  1 (5.3)  1 
Note: All percentages are based on the number of subjects in the critical population and treatment group (N) with ordinal scale baseline of 2.
Note: A subject is counted only once within each category using the event with the worstcase intensity (by severity) or relationship (by causality).
Confidential  Page 42 of 42 