FORM 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT PURSUANT TO

SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report: September 24, 2018

(Date of earliest event reported)

 

 

ANAPTYSBIO, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

001-37985   20-3828755

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

10421 Pacific Center Court, Suite 200

San Diego, CA

  92121
(Address of Principal Executive Offices)   (Zip Code)

(858) 362-6295

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

 

 


Item 7.01 Regulation FD.

On September 24, 2018, AnaptysBio, Inc. (“AnaptysBio”) issued a press release announcing top line proof of concept data from an interim analysis of AnaptysBio’s ongoing etokimab Phase 2a trial in severe eosinophilic asthma. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

On September 24, 2018, AnaptysBio held an investor conference call. A copy of the slides presented during the investor conference call are furnished as Exhibit 99.2 to this report and incorporated herein by reference.

The information furnished with this report, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number

  

Description of Exhibit

99.1    Press release dated September 24, 2018.
99.2    Slides presented by AnaptysBio on September 24, 2018.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AnaptysBio, Inc.
Date: September 24, 2018     By:   /s/ Dominic Piscitelli
    Name:   Dominic Piscitelli
    Title:   Chief Financial Officer
EX-99.1

Exhibit 99.1

 

LOGO

AnaptysBio Reports Positive Topline Data from Phase 2a Proof-of-Concept Clinical Trial of Etokimab in Severe Eosinophilic Asthma

 

   

Lung function improvement occurred rapidly following a single dose of etokimab, with an 8 percent increase in FEV1 over placebo at Day 2

 

   

FEV1 improvement was sustained throughout the interim analysis period, with an 11 percent increase over placebo at Day 64

 

   

Blood eosinophil reduction was consistent with lung function improvement, with 31 percent and 46 percent reduction over placebo at Day 2 and Day 64, respectively

 

   

Management to host conference call today at 8:30 a.m. EDT

SAN DIEGO, Sept. 24, 2018 — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second (FEV1), which is a measure of lung function, with an 8 percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis.

“Eosinophilic asthma is a debilitating medical condition that results from severe inflammation and airway obstruction,” said Dr. Ian Pavord, professor of Respiratory Medicine at University of Oxford and principal investigator of the Phase 2a trial. “The benefit observed in this trial after a single dose of etokimab demonstrates the potential for IL-33 inhibition in treating severe eosinophilic asthma. I look forward to the continued advancement of etokimab in subsequent clinical trials for patients suffering from this chronic life-long disease.”

Phase 2a Trial Design

This Phase 2a proof-of-concept trial enrolled 25 adult severe eosinophilic asthma patients, who were randomized between a single 300mg intravenous dose of etokimab or placebo upon enrollment (Day 1) at six sites located in the United States and the United Kingdom. Upon screening, which occurred seven to 14 days prior to enrollment, patients were required to have a blood eosinophil count of at least 300 per microliter, confirmed clinical diagnosis of severe asthma according to the Global Initiative for Asthma (GINA) 2016, pre-bronchodilator FEV1 of less than 80 percent of predicted and at least one asthma exacerbation within the past 12 months requiring use of rescue medication. Patients were required to be stably maintained on high-dose inhaled corticosteroids (ICS) and long-acting beta-2-agonists (LABA) for at least three months prior to screening and were required to continue ICS/LABA therapy during the course of this trial. Baseline clinical assessments were conducted for each patient on Day 1 prior to etokimab or placebo dose, and patients completed follow-up clinical assessments on Days 2, 8, 22, 36 and


LOGO

 

64 as of this interim analysis. The last follow-up visit for each patient will occur on Day 127 post-dose.

Interim Analysis

Key data and observations as of this interim analysis indicate the following:

 

   

Baseline parameters of etokimab-dosed patients (n=12) were 545 blood eosinophils per microliter, 2.5 liters FEV1 and 65 percent predicted FEV1, while placebo-dosed patients (n=13) had 705 blood eosinophils per microliter, 2.5 liters FEV1 and 66 percent predicted FEV1. Nine of 12 (75%) etokimab-dosed patients were male with an average age of 41, while nine of 13 (69%) placebo-dosed patients were male with an average age of 36.

 

    Etokimab-dosed patients rapidly improved lung function by Day 2, where FEV1 increased by 8 percent over placebo.

 

    FEV1 increase was sustained at Day 64, where etokimab-dosed patients demonstrated an 11 percent increase over placebo.

 

    Blood eosinophil reduction, which is a biomarker illustrative of etokimab’s mechanistic breadth, was observed at 31 percent over placebo at Day 2 and sustained to 46 percent over placebo at Day 64. This reduction correlated with FEV1 improvement and was consistent with the blood eosinophil effects observed in a prior single dose etokimab trial in moderate-to-severe atopic dermatitis patients.
          Change Relative to
Day 1 Baseline
 

Parameter

  

Timepoint

   Etokimab
(n=12)
    Placebo
(n=13)
    Net  

FEV1 Increase (%)

   Day 2      12     4     8
   Day 8      9     5     4
   Day 22      16     8     8
   Day 36      14     8     6
   Day 64      15     4     11

Blood Eosinophil Level (%)

   Day 2      -22     9     -31
   Day 8      -34     -15     -19
   Day 22      -30     -10     -20
   Day 36      -43     1     -44
   Day 64      -40     6     -46
 

 

   

Etokimab was generally well-tolerated by all patients and no serious adverse events were reported as of this interim analysis. No treatment-emergent adverse events were deemed to be etokimab-related, and the most frequent treatment-emergent adverse events reported were single occurrences of moderate strep throat in two etokimab-dosed patients and single occurrences of mild vomiting in two placebo-dosed patients. No exacerbations or rescue therapy usage has been reported as of the interim analysis.

“We are thrilled to have demonstrated proof-of-concept in this single dose Phase 2a trial and look forward to advancing the development of etokimab for patients suffering from eosinophilic asthma,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Genotypic studies have validated the key role played by IL-33 in asthma, and we believe etokimab’s upstream mechanism has the potential for a broad therapeutic benefit across multiple atopic disorders.”


LOGO

 

This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion.

AnaptysBio plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.

Conference Call & Webcast Information

The AnaptysBio management team will host a conference call and live webcast on Monday Sept. 24, 2018, at 8:30 a.m. EDT to discuss the information in this press release.

Dial-in: (833) 696-8361 (domestic) or (430) 775-1625 (international)

Conference ID: 5798647

The live webcast and accompanying slides can be accessed under the investor relations section of AnaptysBio’s website at www.anaptysbio.com. A replay of the conference call will be archived under the investor relations section of the AnaptysBio website for 30 days shortly after the call.

About Etokimab

Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33 (IL-33), a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as moderate-to-severe atopic dermatitis, severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is enrolling its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where data is anticipated in the second half of 2019. The company also plans to initiate its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP by the end of 2018 with data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.

About AnaptysBio

AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (etokimab, previously referred to as ANB020) for the treatment of moderate-to-severe atopic dermatitis, severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP); its anti-IL-36R antibody (ANB019) for the treatment of rare inflammatory diseases, including generalized pustular psoriasis (GPP) and palmoplantar pustulosis (PPP), previously referred to as palmo-plantar pustular psoriasis; and


LOGO

 

novel anti-inflammatory checkpoint receptor modulator antibodies for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation (SHM) platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO and an inflammation partnership with Celgene, including an anti-PD-1 antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab’s Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients and etokimab’s Phase 2 clinical trial in adult patients with CRSwNP; our design of and our ability to launch a Phase 2 clinical trial of etokimab in adults patients with CRSwNP and a Phase 2b clinical trial of etokimab in eosinophilic asthma; and statements by AnaptysBio’s president and chief executive officer. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

###

Contacts:

Monique Allaire

THRUST Investor Relations

617.895.9511

monique@thrustir.com

Chelcie Lister


LOGO

 

THRUST Investor Relations

910.777.3049

chelcie@thrustir.com

EX-99.2
Nasdaq: ANAB
Etokimab (Anti-IL-33) Program
Phase 2a Eosinophilic Asthma Clinical Trial
Interim Data Update
September 24
th
2018
Exhibit 99.2


Safe Harbor Statement
2
This presentation and the accompanying oral presentation contain “forward-looking” statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical
trials, including etokimab’s Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients, etokimab’s Phase 2 clinical trial in adult
chronic rhinosinusitis with nasal polyps patients and ANB019’s Phase 2 trials in GPP and PPP patients; the design of and our ability to launch a
Phase 2 clinical trial of etokimab in adult chronic rhinosinusitis with nasal polyps patients, a Phase 2b clinical trial of etokimab in severe
eosinophilic asthma patients and a Phase 2 clinical trial of ANB019 in PPP patients; the timing of detailed data presentation of etokimab’s Phase
2a clinical trial in severe adult eosinophilic asthma patients; the timing of an IND filing for an anti-inflammatory checkpoint modulator; and the
success of our partnership with TESARO and Celgene. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and
statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as
assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or
implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s
actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related
to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates,
the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the
company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the
company files from time to time with the Securities and Exchange Commission (SEC). These forward-looking statements speak only as of the
date of this presentation, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Certain information contained in this presentation may be derived from information provided by industry sources.  The Company believes such
information is accurate and that the sources from which it has been obtained are reliable.  However, the Company cannot guarantee the
accuracy of, and has not independently verified, such information.
The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be
construed as an endorsement of such products.


Etokimab
Eosinophilic Asthma Phase 2a: Top-line data today
ANB019 Generalized Pustular Psoriasis Phase 2: Top-line data in early
2019
Etokimab Atopic Dermatitis Phase 2b: Top-line data in H2 2019
Etokimab Chronic Rhinosinusitis With Nasal Polyps Phase 2: Top-line
data in H2 2019
ANB019 Palmoplantar Pustulosis Phase 2: Top-line data in H2 2019
AnaptysBio: Clinical-Stage Antibody Development Company
Focused on Novel Antibody Medicines for Severe Inflammatory Diseases
3
TESARO
Celgene
Rapid Antibody Generation
Platform Technology
~2.5 years
Antibody
Discovery
Preclinical &
Translational
IND or
Equivalent Filing
Antibody Medicines
For Severe Diseases
Wholly-Owned
Anti-Inflammatory Pipeline
Etokimab (ANB020, Anti-IL-33)
Atopic Dermatitis, Eosinophilic Asthma & Chronic Rhinosinusitis with Nasal Polyps
ANB019 (Anti-IL-36R)
Generalized Pustular Psoriasis & Palmoplantar Pustulosis
Checkpoint Modulator
Inflammatory Diseases
4 Additional Efficacy Readouts
Anticipated By End 2019
Validating Product Partnerships
Generated ~$75MM*
* As
of
June
30
th
2018


Wholly-Owned and Partnered Product Pipeline
6 AnaptysBio-Generated Antibodies Advanced to Clinic Since Q1 2016
All programs generated internally using AnaptysBio’s proprietary antibody generation platform technology
4


IL-33
acts
as
a
gatekeeper
of
allergic
response
with
demonstrated
activity
in
the
initiation
(activation
of
ILC2
cells)
,
propagation
(activation
of
allergen-specific
T
and
B
cells)
and
amplification
(degranulation
of
mast
cells
and
basophils)
.
5
Etokimab: First-in-Class Anti-IL-33 Antibody
Broadly Applicable to Atopic Diseases
IL-33 is an upstream driver of
atopic disease
Human genetics validate key role of IL-33 in
atopic dermatitis and asthma
Pro-inflammatory cytokine released upon
allergen contact with epithelium
Activates downstream release of IL-4, IL-5
and IL-13
Modulates IgE-mediated mast cell and
basophil degranulation
Etokimab is a potentially first-in-
class anti-IL-33 cytokine
antibody
Phase I healthy volunteer trial completed
without dose-limiting toxicities
AnaptysBio pursuing development in
moderate-to-severe atopic dermatitis,
eosinophilic asthma and chronic
rhinosinusitis with nasal polyps 
1.
Cayrol
et
al.
Curr
Opin
Immunol
(2014)
31:31
2.
Peine
et
al.
Trends
Immunol
(2016)
37(5):321
3.
Saluja
et
al.
Clin
Transl
Allergy
(2015)
5:33
2
1
3


Eosinophilic Asthma
Focus on Severe Patients Inadequately Controlled With ICS/LABA
6
Eosinophilic asthma is a
debilitating, chronic atopic
disease
-
Decreased lung function associated with
poor quality-of-life and exacerbations
-
Often concomitant with other atopic
diseases, such as chronic rhinosinusitis
with nasal polyps and atopic dermatitis
Significant unmet medical need
-
~1.1 million US adults diagnosed with
severe asthma and inadequately
controlled with inhaled corticosteroids and
long-acting-beta-agonists (ICS/LABA)
-
Approximately 50% estimated to be
eosinophilic asthmatics


Etokimab Clinical Trials
7
Subjects
Trial
Trial
Design
Key Clinical
Endpoint(s)
Timing
Healthy Volunteers
Phase 1
n=96, SAD and MAD
cohorts, IV
and SC dosing, randomized,
placebo-controlled
Safety, PK and PD
Top-line data announced October 2016
Detailed data presented at AAD and AAAAI 2017
Moderate-to-Severe
Adult Atopic
Dermatitis
Phase 2a
n=12, single IV dose
Eczema
Area &
Severity Index
(EASI)
Top-line data announced October 2017
Detailed data presented at AAD and EAACI 2018
ATLAS
Phase 2b
n=300,
SC multi-dose, randomized,
placebo-controlled
EASI
Anticipate top-line data in H2 2019
Moderate-to-Severe
Baseline Adult Peanut
Allergy
Phase 2a
n=20, single IV
dose, randomized,
placebo-controlled
Oral Food
Challenge (OFC)
Top-line data announced March 2018
De-prioritized
for commercial reasons
Eosinophilic Asthma
Phase 2a
n=25,
single IV dose, randomized,
placebo-controlled
Forced
Expiratory
Volume in 1
Second (FEV1)
Top-line data announced today
Detailed data presentation anticipated in 2019
Phase 2b
Undisclosed
Undisclosed
Anticipate initiation in 2019
Adult Chronic
Rhinosinusitis with
Nasal Polyps
(CRSwNP)
ECLIPSE
Phase 2
n=100, SC multi-dose,
randomized,
placebo-controlled
Nasal Polyps
Score (NPS); Sino-
Nasal Outcome
Test-22 (SNOT-22)
Anticipate top-line data in H2 2019


8
Etokimab Eosinophilic Asthma Phase 2a Trial
Single Dose of Etokimab or Placebo Administered on Day 1
Patient
Population
ClinicalTrials.gov:  NCT03469934
Etokimab
300mg IV Single Dose + High Dose ICS/LABA 
n=12
Placebo Single Dose + High Dose ICS/LABA 
n=13
Adults with severe asthma (according to GINA 2016)
Pre-bronchodilator FEV1 <80% of predicted
Blood eosinophils
300 cells/microliter
1 asthma exacerbation in past year requiring rescue medication
Stably maintained on ICS/LABA dose for at least 3 months prior to screening
Efficacy: % change in FEV1 relative to baseline
Biomarker: change in blood eosinophil levels
Safety
Key Endpoints


9
Key Baseline Parameters
Average Baseline Parameters of
Enrolled
Patients
(Day 1 Pre-Dose)
Etokimab Arm
Placebo
Arm
n
12
13
Blood
Eosinophils
per microliter
545
705
FEV1
(Liters)
2.5
2.5
% Predicted
FEV1
65%
66%
Age (years)
41
36
Male %
75% (9 of 12)
69% (9
of 13)


% FEV1 Improvement Relative to Baseline After Single Dose
Rapid and Sustained FEV1 Improvement Post-Etokimab Administration
10
Timepoint
Etokimab
Placebo
Net
Day 1
(Baseline)
0%
0%
0%
Day 2
12%
4%
8%
Day 8
9%
5%
4%
Day 22
16%
8%
8%
Day 36
14%
8%
6%
Day 64
15%
4%
11%


Blood Eosinophil Reduction Relative to Baseline After Single Dose
Correlates with FEV1 Improvement and Consistent With Phase 2a Atopic Dermatitis Trial
11
Timepoint
Etokimab
Placebo
Net
Day 1
(Baseline)
0%
0%
0%
Day 2
-22%
9%
-31%
Day 8
-34%
-15%
-19%
Day 22
-30%
-10%
-20%
Day 36
-43%
1%
-44%
Day 64
-40%
6%
-46%


12
Eosinophilic Asthma Phase 2a Day 64 Interim Analysis
Supports Advancement of Etokimab Into Phase 2b Eosinophilic Asthma Trial
Interim Analysis Summary
Etokimab demonstrated proof-of-concept in eosinophilic asthma
Single dose of etokimab resulted in rapid and sustained improvement in FEV1 over placebo
Blood eosinophil biomarker reduction correlated with FEV1 improvement and is consistent
with prior etokimab Phase 2a atopic dermatitis trial 
Etokimab was generally well-tolerated and no serious adverse events reported
-
No treatment-emergent adverse events were deemed to be etokimab-related
-
The most frequent treatment-emergent adverse events reported were single
occurrences of moderate strep throat in two etokimab-dosed patients and single
occurrences of mild vomiting in two placebo-dosed patients
-
No exacerbations or rescue therapy usage was reported
Next Steps
Complete ongoing Phase 2a trial and present detailed data at a medical conference in 2019
Initiate Phase 2b randomized, double-blinded, placebo-controlled, multi-dose trial of
etokimab in eosinophilic asthma during 2019


Anticipated Milestones
4 Additional Efficacy Readouts Anticipated By End 2019
Program
Milestone
Timing
Etokimab
(anti-IL-33)
Moderate-to-Severe
Adult
Atopic Dermatitis Phase 2a Trial
Top-line
data announced October 2017
Detailed
data
presented
at
AAD
and
EAACI
2018
ATLAS:
Moderate-to-Severe
Adult
Atopic Dermatitis Phase 2b Trial
Initiated H1 2018
Top-line data anticipated in H2 2019
Severe Adult Eosinophilic
Asthma Phase 2a Trial
Top-line
data presented today
Detailed data to be presented in 2019
Eosinophilic Asthma Phase 2b Trial
To be initiated
in 2019
ECLIPSE:
Adult Chronic Rhinosinusitis with
Nasal Polyps Phase 2 Trial
To be initiated by
end 2018
Top-line data anticipated in H2 2019
ANB019
(anti-IL-36R)
Healthy Volunteer Top-line Phase I Trial
Top-line data announced November 2017
Detailed data presented at EAACI 2018
GALLOP:
GPP Phase 2 Trial
Initiated H1 2018
Top-line data anticipated in early 2019
POPLAR: PPP Phase 2 Trial
Initiated H2
2018
Top-line data anticipated in H2 2019
Approximately $300MM in cash, cash equivalents and investments as of June 30    2018
13
th


AnaptysBio: Clinical-Stage Antibody Development Company
Focused on Novel Antibody Medicines for Severe Inflammatory Diseases
14
TESARO
Celgene
Rapid Antibody Generation
Platform Technology
~2.5 years
Antibody
Discovery
Preclinical &
Translational
IND or
Equivalent Filing
Antibody Medicines
For Severe Diseases
Wholly-Owned
Anti-Inflammatory Pipeline
Etokimab (ANB020, Anti-IL-33)
Atopic Dermatitis, Eosinophilic Asthma & Chronic Rhinosinusitis with Nasal Polyps
ANB019 (Anti-IL-36R)
Generalized Pustular Psoriasis & Palmoplantar Pustulosis
Checkpoint Modulator
Inflammatory Diseases
4 Additional Efficacy Readouts
Anticipated By End 2019
Validating Product Partnerships
Generated ~$75MM*
Etokimab Eosinophilic Asthma Phase 2a: Top-line data today
ANB019 Generalized Pustular Psoriasis Phase 2: Top-line data in
early 2019
Etokimab Atopic Dermatitis Phase 2b: Top-line data in H2 2019
Etokimab Chronic Rhinosinusitis With Nasal Polyps Phase 2: Top-
line data in H2 2019
ANB019 Palmoplantar Pustulosis Phase 2: Top-line data in H2 2019
* As of June 30     2018
th