Landscape of Innovation - Clearvie€¦ · Within the nucleic acid therapy space, ex vivo therapies are relatively more mature as a class, with a greater proportion of clinical stage

Landscape of Innovation

Drivers of Value for Innovators

June 3, 2019

2 Introduction

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and commercially

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Our ability to deliver actionable recommendations is derived from the depth

of our experience reflecting real world clinical and commercial issues.

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4

We support clients on a broad range of strategic engagements, often

involving innovation-related opportunities to enhance shareholder value.

Example Projects

• Corporate Growth Strategy

• Market or Therapeutic-area Entry

Strategy

• Company P&L

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Prioritization

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• Revenue Forecasting

5

Key Questions for Discussion – Trends in Innovation

VC Pipeline Trends

Which innovative therapeutic classes and modalities

attracted VC funding in 2018? 1

What therapeutic classes stand out as notable areas for

discussion? 2

6

Our analysis looked at the portfolio strategies across 30 companies with the

largest venture raises in 2018 to assess the landscape of innovation.

Source: ClearView Analysis.

VC Pipeline Trends

Top Venture Raises of 2018

Top 15 U.S. Venture Raises Top 15 Ex-U.S. Venture Raises

Pipeline analyses were conducted for the companies above to identify promising, innovative

therapeutic classes that have attracted venture capital funding over the last year

7

The top VC-funded company pipeline is relatively similar in distribution to

the industry pipeline, though a disproportionate focus on oncology exists.

Source: Global Data; ClearView Analysis. 1 Reported as a proportion of total drugs being explored in the Top 10; includes programs designated as discovery, preclinical, P1, P2, P3, and Pre-registration (N=27,661); does not

account for drugs being explored in multiple therapeutic areas.

VC Pipeline Trends

56%

7% 7% 5% 4% 4% 4% 3% 2% 2%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

VC Pipeline Industry Pipeline

Top TAs in VC Development Pipeline Top TAs in Industry Drug Development1

32%

16% 16%

8% 8% 6% 5% 4% 3% 3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

The pipeline for top VC-funded

companies is concentrated

heavily in oncology

Outside of oncology, both the VC-

funded and broad industry

pipelines focus in on infectious

diseases and CNS indications

% o

f P

rog

ram

s

% o

f P

rog

ram

s

8

Venture capital funding in the past year reflects an increasing trend of large

raises directed towards the development of platform technologies.

Source: Global Data; ClearView Analysis. 1 Top 30 VC companies classified based on where majority of pipeline lies (e.g., in small molecules, antibody technologies); 2 Includes assets with undisclosed mechanisms of action.

VC Pipeline Trends

Therapeutic Classes in the VC Development Pipeline

Therapeutic Class % of Pipeline Assets

Recombinant & Fusion Proteins ~4%

Polysaccharides ~2%

Other Therapeutic Classes2 ~16%

Antibody Technology ~24%

Nucleic Acid Technologies (Including Cell and Gene Therapy)

~34%

Small Molecules ~20%

% of Companies1

~30%

~18%

~34%

~3%

~3%

~12%

9

$400 $260

$100

$125

$610

$102

$321

$117 $133

$675

$740

$242

$150

$100

$500

$437

$494

$434

$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

$1,600

$1,800

$2,000

Series A Series B Series C Series D Series E Series F Series G

This focus on disruptive technologies is reflected by the significant growth

in early investments in nascent technologies.

Source: Global Data; ClearView Analysis. 1 Denotes latest development stage in global, U.S., or EU trials.

VC Pipeline Trends

To

tal S

eri

es

Fu

nd

ing

Le

ve

l ($

B)

Funding Rounds by Companies’ Latest Development Stage1

Investment from the top 30

VC raises of 2018 has been

concentrated in early funding

rounds, increasingly so with

large Series A rounds

Discovery Preclinical P1 P2 P3

10

To create value, innovators must differentiate their technologies across

diverse applications while ensuring operational focus and fiscal discipline.

Source: ClearView Analysis.

VC Pipeline Trends

For innovator companies, how do you balance pursuit of a

breadth of potential applications against focused advancement

of a single lead program?

How does the path to value creation differ for innovator

companies focused on a platform technology versus a clearly

defined lead asset?

For investors, what are the greatest value-driving activities that

innovator companies can pursue? What value inflection points

do you consider critical to providing funding?

How have current markets affected your collective approaches

to (seeking) investment? How does the flow of global capital,

and the rise of global innovators, affect your approach?

11

Trends by Therapeutic Class

Nucleic Acid Technology

What have been the key trends in pharmaceutical

development and innovation in 2018? 1


discussion? 2

12

Companies with significant venture capital funding in the past year possess

pipelines that focus heavily on nucleic acid technology and novel antibodies.

Source: Global Data; ClearView Analysis. ADC: Antibody Drug Conjugate.

VC Pipeline Trends

Nucleic Acid Technologies (Including Cell and Gene Therapy)

Antibody Technologies

Small

Molecules Nucleic Acid

Technology

Antibody

Tech

Fusion

Proteins Other

VC Development Pipeline Therapeutic Classes of Interest

Various nucleic acid

modalities are being

explored to address

indications spanning a

broad array of TAs

Bispecific antibodies

comprise ~10% of the

broader antibody

technology pipeline

Ex vivo

In vivo

Non-DNA

Monoclonal Ab

ADC

Bispecific

Poly.

13

Trends by Therapeutic Class – Nucleic Acid Technology





discussion? 2

Nucleic Acid

Technologies

Novel Antibody

Technologies

14

Nucleic acid technologies encompass a variety of therapeutic modalities,

spanning ex vivo and in vivo gene therapies, as well as non-DNA therapies.

Source: ClearView Analysis. ASO: Antisense Oligonucleotide. CAR-NK: Chimeric Antigen Receptor – Natural Killer Cell; CAR-T: Chimeric Antigen Receptor – T cell.


Nucleic Acid Technologies

Example Agents Example Agents Example Agents

• Ex vivo therapies are

produced by transfecting

host cells in vitro and re-

introducing modified cells

• Novel editing techniques

(e.g., ZFN, CRISPR) are

increasingly being used in

addition to viral vectors

• In vivo approaches include

extra-chromosomal

therapies employing viral

vectors (e.g., AAV) and

therapies that perform

genome editing within the

body

• RNA-based therapies are

used to modify translation

in various ways

• ASOs / RNAi inhibit gene

expression, while mRNA

therapy uses translation of

delivered mRNA to confer

therapeutic benefit

Ex Vivo Gene Therapies 1 In Vivo Gene Therapies 2 Non-DNA Nucleotide

Therapies 3

Extra-chromosomal

Gene Therapy

In Vivo Genome

Editing

Antisense

Oligonucleotides (ASO)

mRNA Therapy

Adoptive Cell

Therapy

Ex vivo Stem Cell

Therapy

RNAi

15

Within the nucleic acid therapy space, ex vivo therapies are relatively more

mature as a class, with a greater proportion of clinical stage programs.

Source: Global Data; ClearView Analysis. 1 Distribution of industry-wide pipeline by development phase. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


0

10

20

30

40

50

60

70

80

90

100

10%

Preclinical Discovery Phase 3 Phase 1

29%

Phase 2

13%

20%

57%

36%

15%

54%

26%

45%

11%

26%

16%

8%

14%

2% 2%

7%

0%

7%

Nucleic Acid Therapy Pipeline Distribution by Development Phase

Pro

po

rtio

n o

f C

las

s P

ipe

lin

e (

%)

Agents in each nucleic acid

therapeutic class have

successfully been approved in

the past few years (e.g., Kymriah,

Luxturna, Spinraza)

The non-DNA nucleic acid therapy pipeline

(e.g., antisense, RNAi) is relatively more

nascent, and primarily concentrated in

discovery and preclinical stages

Ex Vivo In Vivo Non-DNA Industry (Index)1

16

The ex vivo gene therapy pipeline is concentrated heavily in oncology, where

approved CAR-Ts have validated the therapeutic class.

Source: Global Data; ClearView Analysis. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


Top 10 TAs in the Ex Vivo Gene Therapy Pipeline

Nu

mb

er

of

Tri

als


0

100

200

300

400

500

600

700

800

900

1,000

1,100

Infect. Oncology Genetic

30

Hem. Derm. Immun. CNS Metabolic Musc. Cardio

1,017

42 40 18 13 10 9 8

31

Ex vivo gene therapies continue to

focus primarily in oncology, given the

precedent set by approved CAR-Ts

(e.g., Kymriah, Yescarta)

Interest in genetic and hematological

disorders has waned, potentially due to

technological innovations that have facilitated in

vivo gene therapy interventions

17

Late-stage ex vivo therapy programs are being pursued by public companies

of all sizes, while early programs are driven by small, private biotechs.

Source: Global Data; Evaluate Pharma; ClearView Analysis. 1 Juno and Kite have been acquired by larger biopharmaceutical companies (Celgene and Gilead, respectively). Note: Includes non-global programs captured by

Global Data (e.g., development solely in China).


Kite

Juno

Novartis

Shanghai

GeneChem

25

Bellicum

PersonGen

Takara

Innovative

Cellular 9

Autolus

Mustang

18

17

13

13

10

9

9

9

P1

P2

P3

Key Players

(P1 – 3 Programs, 2019)

Top Players in the Ex Vivo Gene Therapy Pipeline

70% 64% 69% 71%

25%

14% 14%

10% 10%

21%

3% 4%

5% 2%

9% 10% 6%

21%

2%

8%

5% 7% 10% 12% 25%

P3 Discovery

PC P1

5%

P2

Distribution of Ex Vivo R&D Projects

by Market Cap (2019)

>$10 B $1 – 5 B <$0.5 B

$5 – 10 B $0.5 – 1 B Private

128 443 316 320 24

18

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

$200

Jul-14 Jan-15 Jul-15 Jan-16 Jul-16 Jan-17 Jul-17 Jan-18

Companies like Kite Pharma have driven tremendous value by advancing

their platform and demonstrating differentiated clinical benefit.

Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. NHL: Non-Hodgkin’s Lymphoma; R/R: Relapsed/Refractory.


Ex Vivo Gene Therapy Development Case Study

Sh

are

Pri

ce

($ p

er

sh

are

)

Company:

1 1/1/15

P1/2 trial in NHL

patients initiated

(ZUMA-1)

2 11/9/15

P2 trial initiated in R/R

Mantle Cell Lymphoma

(ZUMA-2)

3 2/28/17

Positive data from

primary analysis of

ZUMA-1 announced

4 8/28/17

Gilead announces

acquisition of Kite for

$11.9 B

Gilead acquisition completed on 10/3/17, with

Yescarta approved by the FDA on 10/18/17

Agent: Indication: R/R Large B-cell Lymphoma

19

The in vivo pipeline focus is spread more evenly across TAs compared to the

ex vivo pipeline, with heavy investment in CNS and ophthalmology.

Source: Global Data; ClearView Analysis. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


Top 10 TAs in the In Vivo Gene Therapy Pipeline

Nu

mb

er

of

Tri

als


0

50

100

150

200

250

300

350

CNS Oncology

53

Ophth. Musc. Hem. Metabolic Cardio. Infect. Resp. Immun.

305

157

126

17

112

52 47

26 25

Most recently, the FDA approved Zolgensma

(Novartis/Avexis) for spinal muscular atrophy

in May 2019

By definition, the vast majority of

indications included in the listed

therapeutic areas possess a

genetic basis to disease

20

Early research is dominated by private biotechs while larger pharma

companies typically become involved in later stages of development.

Source: Global Data; Evaluate Pharma; ClearView Analysis. PC: Preclinical. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


DNAtrix

RegenxBio

ViroMed

Vyriad

Sarepta

Candel

MeiraGTx

7

Targovax

Sangamo

Oncosec

9

9

8

6

5

5

5

5

5

P1

P2

P3

Key Players

(P1 – 3 Programs, 2019)

Top Players in the In Vivo Gene Therapy Pipeline

61% 66% 72%

43% 30%

16% 14%

10%

23%

26%

9% 7% 3%

6% 15%

11% 8%

18% 22%

1% 1% 2% 3%

3% 8% 7% 7%

Discovery

PC P1 P2

4%

P3

4%

Distribution of In Vivo R&D Projects


>$10 B $1 – 5 B <$0.5 B

$5 – 10 B $0.5 – 1 B Private

122 557 107 159 27

21

$0

$5

$10

$15

$20

$25

$30

Jan-17 Jul-17 Jan-18 Jul-18 Jan-19

Sangamo generated meaningful value in part through partnerships that

validated its strategy, though mixed trial results have impacted that value.

Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. MPS: Mucopolysaccharidosis.


In Vivo Gene Therapy Development Case Study

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($ p

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)

Company: Key Agent(s):

1 5/10/17

Collaboration with

Pfizer on Hem. A

gene therapy

2 11/15/17

First ever patient

dosed with in vivo

genome editing

therapy (SB-913)

3 1/3/18

Pfizer collaboration

expanded to CNS

disorders

4 9/5/18

Stock drops due to

mixed reactions to

early results from

SB-913 trial

5 4/3/19

Sangamo and

Pfizer release

positive data from

ALTA study

SB-525 (Hemophilia A); SB-318 (MPS I); SB-913 (MPS II)

Though partnerships with Pfizer

helped drive valuation, mixed trial

results have dampened

Sangamo’s trajectory

$1.1 B

Market Cap

22

Top 10 TAs in the Non-DNA Nucleic Acid Therapy Pipeline

The pipeline focus of non-DNA therapies is relatively similar to that of the

industry pipeline, though greater emphasis is placed on genetic disorders.

Source: Global Data; Evaluate Pharma; ClearView Analysis. CNS: Central Nervous System; GI: Gastrointestinal. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


0

50

100

150

200

250

Oncology Infectious CNS Cardio Ophth.

29

Immun.

244

86

49 43

Genetic

Disorders

122

37

Metabolic

29

Resp.

20

GI

29


Nu

mb

er

of

Tri

als

Genetically-defined disorders span many of

the therapeutic areas listed, with particular

concentration in CNS (e.g., Huntington’s

disease, spinal muscular atrophy)

23

Key players in the late-stage pipeline are comprised of large biotechs that

have recently started to commercialize assets (e.g., Ionis, Alnylam, Sarepta).

Source: Global Data; Evaluate Pharma; ClearView Analysis. PC: Preclinical. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


Ionis

Moderna

AstraZeneca

BioNTech

Akcea

Curevac

Alnylam

ProQR

Sanofi

Sarepta

16

11

5

5

5

4

4

3

3

3

P1

P2

P3

Key Players

(P1 – 3 Programs, 2019)

67% 61%

36% 25%

14%

12% 20%

13%

15% 31%

10% 2%

4%

7%

14%

6% 4%

5% 10%

7%

4%

22%

8%

21%

1% 8% 20%

36%

14%

Discovery

PC P2 P1 P3

4%

Distribution of Non-DNA R&D Projects


>$10 B $1 – 5 B <$0.5 B

$5 – 10 B $0.5 – 1 B Private

Top Players in the Non-DNA Nucleic Acid Therapy Pipeline

222 411 55 61 17

24

$0

$20

$40

$60

$80

$100

$120

$140

$160

$180

Jan-12 Jan-13 Jan-14 Jan-15 Jan-16 Jan-17 Jan-18 Jan-19

Alnylam has driven its value through a collaboration model for its lead

program, with a diverse pipeline of therapies in tow.

Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. ATTR: Transthyretin-mediated Amyloidosis.


Non-DNA Nucleic Acid Development Case Study

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)

Company: Agent: Indication: Polyneuropathy of hereditary ATTR

1 7/6/12

Positive P1 Trial

Results

2 10/22/12

Enters into alliance

with Genzyme to

develop Onpattro

3 11/10/13

Positive P2 trial

results

4 9/20/17

Positive topline

results from P3

APOLLO study

5 8/10/18

Onpattro approved

by FDA as first

RNAi therapeutic

Revusiran

discontinued due

to safety concerns

(Oct. 2016)

Stock drops following release

of Q2 2015 earnings report

showing missed revenues

$7.24 B

Market Cap

25

Trends by Therapeutic Class – Bispecific Antibodies

Bispecific Antibodies




discussion? 2

Nucleic Acid

Technologies

Novel Antibody

Technologies

26

While mAbs have historically been used and studied widely, bispecific

antibodies represent a relatively newer class of antibodies.

Source: ClearView Analysis. ADC: Antibody Drug Conjugate; TA: Therapeutic Area.


Key Antibody Technologies in Development

Example Agents Example Agents Example Agents

Key: Today’s Focus

• Traditional mAbs have been

used widely across various

therapeutic areas

• Concentration within both

marketed and pipeline

agents is heaviest in

oncology and immunology

• ADCs have been developed

to increase potency of

antibodies by linking them

to cytotoxic agents

– The ADC class is still

emergent, with few

approved agents

• Bispecific antibodies are

increasingly being explored

as novel interventions

• Within the oncology space,

bispecific antibodies have

been deployed to recruit T

cells to tumor cells

Traditional Monoclonal

Antibodies 1

Antibody Drug

Conjugates (ADC) 2

Bispecific

Antibodies 3

Cytotoxic

Agent Linker

Binds Distinct

Epitopes

27

• Bispecific antibodies in oncology have

focused heavily on liquid tumors, aiming to

target T cells (e.g., CD3) and cell surface

markers (e.g., CD19) on B cells

• Though only two bispecifics are approved in

the U.S., pipeline activity continues to grow

• Bispecific antibodies were prominent at ASH

2018, while early-stage activity has emerged

in the immunology space (e.g., RA)

Bispecific Antibody Overview

Bispecific antibodies have been approved in oncology and hematology

indications, though pipeline activity is primarily concentrated in oncology.

Source: ClearView Analysis. ALL: Acute Lymphocytic Leukemia; RA: Rheumatoid Arthritis. 1 Blincyto was also granted accelerated approval to treat B-cell precursor ALL patients who are in remission, bust still have minimal

residual disease (MRD).


Approved Agents Description of the Technology

Manufacturer

Target

Indication1

CD19 x CD3

Amgen

Refractory B-cell precursor ALL

Manufacturer

Target

Indication

Roche

Factor IXa x Factor X

Hemophilia A

Possess two

antigen-binding

sites

28

The bispecific antibody pipeline is relatively nascent compared to the

industry pipeline, with few programs in late-stage trials.

Source: Global Data; ClearView Analysis. DME: Diabetic Macular Edema; nAMD: Neovascular (wet) Age-related Macular Degeneration. Note: Includes non-global programs captured by Global Data (e.g., development solely in

China).


7%

Phase 3

Phase 1

Phase 2

7%

Preclinical 43%

Discovery

1%

14%

21%

15%

45%

29%

20%

Pipeline Distribution by Phase

Bispecific Distribution Industry Distribution

Maturity of the Bispecific Antibody Pipeline

The vast majority of

bispecific development

programs have yet to

enter human trials

P3 trials include faricimab

(Roche) in DME and nAMD, as

well as additional Blincyto trials

29

Bispecific antibody development across all stages is highly concentrated in

oncology, with an overwhelming focus on liquid tumors in late-phase trials.

Source: Global Data; ClearView Analysis. CNS: Central Nervous System; GI: Gastrointestinal. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


0

50

100

150

200

250

300

350

400

450

Oncology Immun. Infect. Metabolic GI Cardio Ophth. CNS Heme. Derm.

30

429

24 11 10 7 5 4 4 3


Though Hemlibra was approved

in Hemophilia A, development

in hematological disorders is

currently sparse

Nu

mb

er

of

Tri

als

Top 10 TAs in the Bispecific Antibody Pipeline

Late-stage development is highly

concentrated in oncology as multiple

companies aim to improve upon

Blincyto’s dosing frequency and safety

profile

Clinical stage development in

immunology includes indications

such as rheumatoid arthritis and

systemic lupus erythematosus

30

Key Players in the Bispecific Antibody Pipeline

Larger cap companies (>$10 B) dominate the late-stage pipeline, while

private companies make up a significant portion of early-stage R&D activity.

Source: Global Data; ClearView Analysis. PC: Preclinical Note: Includes non-global programs captured by Global Data (e.g., development solely in China).


73%

52%

23% 24%

100%

8%

17%

10%

24%

2%

4%

5%

8%

9%

10%

13%

3%

8% 14%

50% 43%

Discovery

P1 PC P2 P3

Distribution of Bispecific R&D Projects


>$10 B $1 – 5 B <$0.5 B

$5 – 10 B $0.5 – 1 B Private

MacroGenics

Roche

Alphamab

Merus

Amgen

J&J

Regeneron

Xencor

Eli Lilly

AstraZeneca

Zymeworks

9

19

Affimed

19

9

8

7

6

4

4

4

3

3

Key Players

(P1 – 3 Programs, 2019)

P1

P2

P3

156 230 111 37 6

31

$0

$10

$20

$30

$40

$50

$60

Jan-14 Jul-14 Jan-15 Jul-15 Jan-16 Jul-16 Jan-17 Jul-17 Jan-18 Jul-18 Jan-19

Xencor has seen a rise in its valuation through parallel development of

multiple programs and partnerships.

Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. AML: Acute Myeloid Leukemia; R/R: Relapsed / Refractory. 1 The collaboration with Novartis was recently terminated, citing strategic pipeline

reprioritization by Novartis; 2 XmAb14045 trial also includes other CD123-expressing hematologic malignancies.


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Company: Therapeutic Area(s): Immuno-oncology, autoimmune diseases

1 12/18/14

Enters discovery

collaboration with

Novo Nordisk

2 6/28/16

Enters Novartis

collaboration for

XmAb14045 and

XmAb136761

3 8/1/16

XmAb14045

initiates P1 trial in

R/R AML2

4 7/5/18

First patient dosed

in P1 XmAb20717

trial in solid tumor

patients

5 11/1/18

Positive results

announced for

XmAb14045 P1

trial

Partial clinical hold was placed

on XmAb14045 in Feb. 2019

after two patient deaths

Outside of the bispecific space,

Xencor has entered

collaborations with companies

such as Alexion and Morphosys

Bispecific Antibody Development Case Study

$1.86 B

Market Cap

32

Copyright © 2019 ClearView Healthcare Partners LLC. All rights reserved.

This document/analysis is the work-product of ClearView Healthcare Partners,

a firm that provides biomedical consulting services to life sciences

companies. The information contained in this document has been obtained

from sources that we believe are reliable, but we do not represent that it is

accurate or complete, and it should not be relied upon as such. This report

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Landscape of Innovation - Clearvie€¦ · Within the nucleic acid therapy space, ex vivo therapies are relatively more mature as a class, with a greater proportion of clinical stage