Illuminating Hope in the Fight Against Cancer

Statements made about Genelux Corporation, other than statements of historical fact, reflect Management’s current beliefs and assumptions founded on the data and information currently available to us. Statements of the company’s progress, results, timing of pre-clinical and clinical trials and projections for product pipelines are examples of forward-looking statements. By definition, such undertakings involve risks, uncertainties and assumptions, and are subject to a number of such factors that could cause actual results to differ substantially from statements made, including but not limited to: risks associated with the success of clinical trials, research and development programs, regulatory approval processes for clinical trials, competitive technologies and products, patents, inception and/or continuation of corporate and other strategic partnerships and the need for additional funding or financing.

The information contained in this presentation does not purport to be all-inclusive or

to contain all of the information that prospective investors may desire. In all cases, interested parties should conduct their own investigation and analysis of Genelux’s business. No representation or warranty is made as to the accuracy or completeness of these materials, and the only representations or warranties that will be made in connection with any further investment will be the representations and warranties as may be set forth in the definitive documentation executed by a duly authorized representative of Genelux.

Genelux Forward Looking Statement

2

OUR COMPANY

3

Research Collaborations

• Memorial Sloan-Kettering Cancer

Center, (New York, New York)

• University of Tuebingen, (Germany)

• Institute of Cancer Research, (UK)

• Univ. California, San Diego

• University of Würzburg, (Germany)

• National Institutes of Health

• University of Leeds (UK)

Contract Manufacturing

Business Office Redlands, CA, USA

Product Analysis Bernried, Germany

Headquarters; Research and Development San Diego, CA, USA

As of Oct. 2014, the Company has 23 employees in the US, and 7 in Germany.

Company Overview

Management

• Tom Zindrick, JD, President & CEO

• Albert Roeder, PhD, COO

• John Prunty, CFO

– Former - Optimer, Gen-Probe

• Paul Scigalla, MD, PhD, CMO

– Former - Pfizer, SUGEN, Boehringer Mannheim, Pharmacia

5

Chief Clinical Advisor • Yuman Fong, MD

– Chairman, Dept. of Surgery, City of Hope

Board of Directors (Majority Independent) • James Tyree, • Thomas Zindrick, JD, - Chairman of the Board - President & CEO – Former – Sugen, Abbott • George Vandeman, JD, Vice Chairman • Ron Simus, DDS – Former – Latham & Watkins, Amgen - First investor • John Thomas, MA, MBA, PhD – Dean, La Sierra University • Billy J. Parrott, BS – President of Private Networks • Dr. Peter Kroll, MD – Founder, Medical Director, CPS

Board and Management

PLATFORM TECHNOLOGY:

ONCOLYTIC VACCINIA VIRUS

6

Most successful biologic in history: safely used in millions of people as the vaccine against smallpox

Genetically stable DNA virus

Replicates in the cell cytoplasm, does not alter the host genome

Infects and kills broad range of cancer cells

Large genetic information carrying capacity - potential inclusion of additional genes to produce therapeutic proteins or improve diagnostic capability

Travels in bloodstream to distant tumors

7

VACCINIA VIRUS’ COMPETITIVE ADVANTAGE

Cowpox & the eradication of smallpox

Milkmaids infected with cowpox (a disease similar to smallpox, but much less virulent)

protected them from smallpox

Observations of natural phenomena

Milkmaids generally immune to smallpox

Hypothesis

Jenner’s vaccine

Jenner's vaccine laid the foundation for contemporary discoveries in immunology. In 1979, the World Health Organization declared smallpox an eradicated disease.

Cowpox vaccine provided protection to smallpox

Vaccinia vaccine

Vaccinia

Modern smallpox vaccine e.g., LIVP strain of vaccinia

A common ancestral virus

Cowpox Vaccinia Variola (the causative agent of smallpox

Jenner’s vaccine

Smallpox has an excellent safe use history

Adverse evens per million vaccinees

Spontaneous remission of leukemia following smallpox vaccination

Vaccinia for the treatment of cancer - Example of historical efforts

50 tumor lesions were inoculated with vaccinia vaccine. There was an accompanying systemic reaction, with fever, rigors, and malaise. All lesions continued to regress, leaving only a few impalpable pigmented spots, where histological examination showed no melanoma cells. The patient has remained well. “The mode of action of vaccinia virus in malignant melanoma is not clear.” - authors

Vaccinia for the treatment of cancer - Example of historical efforts

Treating cancers by AS strain of vaccinia in Japan in 1980’s.

I.v. injection of AS strain virus (Case #1: 108 pfu 22 days, 2×108 pfu 20 days; Case #2: 2×108 pfu 3x per wk for 7 wks, then 4×108 pfu & 8×108 pfu for unknown number of times). Antitumor effect against lung & bone mets observed in two cases.

I.v. injection of AS strain virus. Demonstrated significant reductions in patient’s IgA monoclonal protein levels (monoclonal elevations of IgA characterize multiple myeloma).

Oncolytic Vaccinia Virus for Cancer Therapy

Observations of spontaneous cancer remission after virus infection (e.g., remission of leukemia after smallpox vaccination)

Use of natural virus or vaccine virus for cancer treatment (e.g., treating multiple myeloma with AS strain of vaccinia)

1980’s

1900’s -

1970’s

Genetically engineered virus for cancer treatment (e.g., attenuated GL-ONC1 virus for treatment of cancers)

1998 till

now

Recombinant DNA technology

Role of genetic engineering: Attenuation of virus for safety Tumor targeting (e.g., TK mutation) Arming virus w/ additional diagnostic & therapeutic genes

GLV-1h68 (i.e. GL-ONC1)

lacZ PsEL P7.5

ruc-gfp PsEL

gusA rtfr

J2R F14.5L A56R

P11

Zhang et al. 2007, Cancer Research, 67:10038-46

Insertion site: I II III

Inserts:

I. Renilla luciferase – GFP fusion protein expression cassette (RUC+ GFP+)

II. β-galactosidase expression cassette (β-Gal+)

III. β-glucuronidase expression cassette (β-Gluc+)

Vaccinia Virus (Lister) with three insertional mutations constructed early 2003

15

Eradication of Solid Human Breast Tumors in Nude Mice with an

Intravenously Injected Light-Emitting Oncolytic Vaccinia Virus

Days after Virus Injection

M

ean T

um

or

Volu

me

Treated Untreated

GLV-1h68 is effective as a monotherapy

Zhang et al. 2007, Cancer Research, 67:10038-46 16

anti-tumor response in 3 phases

Body weight comparison of tumor-bearing mice with and without GLV-1h68 treatment

17

• Analysis of the lungs of 12 PC-3 tumor-bearing mice for the presence of PC-3 cells

• RT-PCR using primers for human β-actin

Lun

gs p

osi

tive

fo

r h

um

an β

-ac

tin

(%

)

GLV-1h68 completely eliminated hematogenous metastases in lungs 21 days after virus injection

GLV-1h68 Colonized & Eradicated Metastases

18

Single injection of GLV-1h68 virus resulted in dramatic reduction of CTCs in the blood of mice bearing metastatic

human prostate (PC-3) tumors

0

200

400

600

800

1000

1200

PBS 1h68

CTC

s/m

l

14 days post treatment

All CTCs detected in 1h68-treated mice were infected tumor cells

19

0

200

400

600

800

1000

1200

1400

1600

30 40 50 60 70 80 90 100

Avera

ge t

um

or

vo

lum

e (

mm

^3)

Time after PANC-1 cell implantation (days)

GLV-1h68 + cisplatin

GLV-1h68

No treatment

cisplatin

GLV-1h68 is effective in Combination with Chemotherapy

Yu et al. 2009, Molecular Cancer Therapy, 8: 141-151 20

Virus + radiotherapy showed synergistic activity against pancreatic cancer

Dai et al., Cancer Letters 344 (2014) 282–290

In vitro synergy Enhanced apoptosis

Enhanced in vivo effect

GLV-1h151

TM: V+XRT synergistically enhance therapy.

Viruses with Imaging Genes

Viruses with Therapeutic Genes

Viruses with genes for tissue regeneration & reprogramming

human somatic cells to pluripotency

Optical imaging Immune modulatory molecules Tissue regeneration genes

PET imaging Anti-angiogenic genes Tissue reprogramming genes

MRI imaging Metastasis suppressor genes

Cell matrix-degradative genes

Hormones

microRNAs and many more…

22

NOVEL RECOMBINANT VACCINIA VIRUSES FOR TUMOR DIAGNOSIS & THERAPY

> 500 new recombinant

VACVs produced by Genelux

0

100

200

300

400

500

600

D14 D18 D21 D25 D29 D33 D36 D40

Tu

mo

r v

olu

me (

mm

3)

Day

Virus Iodine Control Virus+Iodine

GLV1h-153 treatment

131I treatment

Virus Expressing hNIS + 131I Eliminated Triple Negative Breast Tumors

Gholami et al. 2014, FASEB J, 28:676-82 23

Intra-pleural treatment with GLV-1h153 eradicates tumor burden

Belin et al. 2013, Surgery, 154:486-93

24

131I-SPECT/CT imaging of hNIS specific uptake of 131I in pleural tumor deposits

Belin et al. 2013, Surgery, 154:486-93 25

1. Intravenous (IV) GLV-1h100 (1x107 PFU)

Randomize 2. Intravenous (IV) GLV-1h164 (1x107 PFU)

3. PBS

Single Dose of GLV-1h164 Causes Greater TNBC Tumor Regression in vivo Than Its Parent Virus

Methods

Day 14 Day 0

Outcome measures: tumor volume mouse weight toxicities

Day 36

0

100

200

300

400

500

600

14 18 20 22 25 27 29 32 34 36

Tum

or

volu

me

(mm

3)

Time (days)

Control 1h100 1h164

Gholami et al. unpublished 26

GLV-1h164: encoding anti-VEGF single chain antibody

Control

GLV-1h100 GLV-1h164

GLV-1h164 Decreases Vascular Flow to TNBC in vivo A

nim

al 1

A

nim

al 2

27

CLINICAL DEVELOPMENT

28

Well tolerated & specifically targets,

replicates in and lyses tumor cells

•May be delivered via systemic, regional or local routes

•Spares healthy tissues and cells, minimizing toxicity and side effects

•Colonizes and lyses in wide range of tumor types

• Infects free-floating tumor cells (ascites) and circulating tumor cells

Activates patients’ immune response

against tumors

•Harnesses the body’s immune response to recognize and fight against tumor

•Trains body’s immune system to deliver a sustained attack on residual and new cancer cells

Can be armed with transgenes for specific delivery & amplification

in tumor cells

•Enhancing Anti-cancer therapy (targeting, efficacy)

•Enabling real-time optical and/or deep tissue imaging

•Allowing immuno-modulation to improve therapeutic outcomes and quality of life

•> 500 viral vectors with > 110 transgenes

29

GENELUX VACCINIA ONCOLYTIC IMMUNOTHERAPY PLATFORM

GENELUX VACCINIA ONCOLYTIC IMMUNOTHERAPY PLATFORM

Delivering a powerful, targeted and sustained attack on cancer…wherever it may reside

Clinical Site Location

Phase

Disease Indication

Route of Delivery

Combination Therapy

# of Patients Treated

# of Total

Infusions Given

Royal Marsden GL-ONC1-002/MA

I Solid tumors i.v. - 27 129

Royal Marsden/ Surrey GL-ONC1-002/MA

Ib Solid tumors i.v. - 16 104

Tübingen GL-ONC1-004/TUE

I/II Peritoneal carcinomatosis

Intraperitoneal (i.pe.)

- 9 23

UCSD GL-ONC1-005/UCSD

I H & N carcinoma i.v. Cisplatin + radiation

17 24

MSKCC GL-ONC1-003/MSK

I Mesothelioma; Malignant pleural effusion

Intrapleural (i.pl.)

- 14 14

TOTALS 83 294

GL-ONC1

Rationale: - Route of delivery: systemic vs. regional; - Monotherapy vs. combination therapy 30

First-in-Human Phase I & Ib Trial in United Kingdom

A Phase I Open-Label, Dose-Escalating Study of the Safety, Tolerability, and Tumor-Specific Replication of the Intravenous Administration of Green

Fluorescent Protein Encoded Genetically Engineered Attenuated Vaccinia Virus, GL-ONC1, with Real-Time Imaging in Patients with Advanced Solid Organ Cancers

Prof. Kevin Harrington Prof. Johann de Bono

Principal Investigators

Prof. Hardev Pandha

31

GL-ONC1-002/MA Dose-escalation Design

28-day cycle

14-day cycle

14-day cycle

Phase I

Phase Ib

← current 7 to 14-day cycle

5 consecutive days

Cohort 8: 1.667×109 pfu

Cohort 8a: 1.667-3×109 pfu

Cohort 8b: 1.667-5×109 pfu

Cohort 8c: 1.667-5×109 pfu

Cohort 8d: 1.667-5×109 pfu

Phase Ib: 3×109 pfu 28-day cycle

32

Patient Demographics - GL-ONC1-002/MA

TUMOR TYPE TOTALS %

Colorectal 7 17

Melanoma 6 14

Head & Neck 6 14

Parotid 3 7

Cholangiocarcinoma 3 7

Renal cell carcinoma 3 7

Esophagus 3 7

Non-small cell lung cancer 2 5

Rectal carcinoma 2 5

Prostate cancer 2 5

Thyroid 1 2

Myxoid chondrosarcoma 1 2

Pleural carcinoma 1 2

Adenocarcinoma - appendix 1 2

Pleural Mesothelioma 1 2

Ovarian 1 2

TOTALS 43 100

SEX

Male 33 (78%)

Female 10 (22%)

TOTAL NUMBER OF GL-ONC1 INFUSIONS / BOLUS

233

AGE

Range 39-79

Median Age 61

ETHNICITY

Caucasian 41 (95%)

Afro-Caribbean

1 (5%)

Asian 1 (5%)

33

Phase I / II Trial at University Hospital Tübingen

Phase I/II study of intraperitoneal administration of GL-ONC1, a genetically modified vaccinia virus,

in patients with peritoneal carcinomatosis

Prof. Dr. med

Michael Bitzer

Prof. Dr. med.

Ulrich M. Lauer

Principal Investigator Co-Investigator

34

Dose-escalation Design GL-ONC1-004/TUE

Phase I

Phase II

← current

Cohort 2: 1×108 pfu

Cohort 3: 1×109 pfu

Cohort 4: 3×109 pfu

Cohort 5: 5×109 pfu

Cohort 1: 1×107 pfu

Recommended Phase II Dose ?

first i.p. adminstration (107 pfu)

GL-ONC1

35

Patient Demographics GL-ONC1-004/TUE

TUMOR TYPE TOTALS %

Ovarian Cancer 4 45

Mesothelioma 3 33

Gastric cancer 2 22

TOTALS 9 100

SEX

Male 2 (22%)

Female 7 (78%)

TOTAL NUMBER OF GL-ONC1 INFUSIONS / BOLUS

23

AGE

Range 39-69

Median Age 56

ETHNICITY

Caucasian 9 (100%)

36

Phase I trial at UCSD Moores Cancer Center

Phase I Trial of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously with Concurrent Cisplatin and Radiotherapy in

Patients with Locoregionally Advanced Head and Neck Carcinoma

Dr. Loren Mell Dr. Sunil Advani Dr. Gregory Daniels

Clinical Investigators

37

Dose-escalation Schedule GL-ONC1-005/UCSD

Phase I

Cohort 1: 3×108 pfu

Cohort 2: 1×109 pfu

Cohort 3: 3×109 pfu

Cohort 4: 3×109 pfu, 2 doses

Cohort -1*: 1×108 pfu

CURRENT

* Necessary only if toxicity is encountered at the initial dose level

Cohort 5: 3×109 pfu, 4 doses

Cohort 6: 3×109 pfu, 6 doses

38

14 Patients (4 Cohorts) Treated GL-ONC1-005/UCSD

TUMOR LOCATION

N %

Larynx 3 21

Hypopharynx 3 21

Base of tongue 2 14

Primary of unknown origin 2 14

Nasopharynx 1 7

Oropharynx 1 7

Adenoid & paranasal sinus 1 7

Parotid gland 1 7

TOTALS 14 100

SEX Male 13

Female 1

AGE

Range 23-77

Median Age 60

ETHNICITY

Caucasian 12 Black or African American

2

TOTAL NUMBER OF GL-ONC1 INFUSIONS / BOLUS

19

39

Phase I Trial at MSKCC

A Phase I Study of intra-pleural administration of GL-ONC1, a genetically modified vaccinia virus, in patients with malignant

pleural effusion: primary, metastases and mesothelioma

Dr. Valerie Rusch Dr. Lee Krug

Clinical Investigators

40

Dose-escalation Schedule GL-ONC1-003/MSK

Phase I

Cohort 1: 1×107 pfu

Cohort 2: 1×108 pfu

Cohort 4: 3×109 pfu

Cohort 3: 1×109 pfu

Cohort -1*: 1×106 pfu

completed

One treatment per cohort

* Necessary only if toxicity is encountered at the initial dose level

41

8 Patients Treated GL-ONC1-003/MSK

TUMOR TYPES

N %

Mesothelioma 9 75

Non-small cell lung cancer 2 17

Breast cancer 1 8

TOTALS 12 100%

SEX

Male 9 (75%)

Female 3 (25%)

TOTAL NUMBER OF GL-ONC1 INFUSIONS

12

42

Safety

Shedding

PK / PD

Infection of tumor tissue/cells

Anti-vaccinia antibody response

Infectivity of baseline tumor biopsy in petri dish

Antitumor response

Key Considerations

43

Is GL-ON1 Viral Therapy Safe?

44

Related Adverse Reactions GL-ONC1-002/MA

AE Term G1 (Mild)

G2 (Moderate)

G3 (Severe)

G4 (Life-

threatening)

Total

Fever 34 8 0 0 42

Lymphopenia 1 6 7 2 16

Fatigue 9 4 0 0 13

Nausea 11 1 0 0 12

Chills 9 2 0 0 11

Increased Gamma-glutamyltransferase (GGT)

4 4 3 0 11

Vomiting 8 3 0 0 11

Hypotension 3 6 0 0 9

Rigors 6 2 0 0 8

Increased Alkaline Phosphatase 3 3 2 0 8

TOTALS 88

(62%) 39

(28%) 12

(9%) 2

(1%) 141

(100%)

45

Related Adverse Reactions GL-ONC1-004/TUE

AE Term G1 (Mild)

G2 (Moderate)

G3 (Severe)

G4 (Life-

threatening)

Total

Increased C-reactive Protein 1 15 0 0 16

Fever 13 3 0 0 16

Decrease in lymphocyte count 0 5 3 0 8

Nausea 7 1 0 0 8

Abdominal pain 4 1 1 0 6

Vomiting 4 0 0 0 4

Flatulence 3 0 0 0 3

Leucocytes increased in ascites 0 0 3 0 3

Chills 2 0 0 0 2

Fatigue 0 0 2 0 2

TOTALS 34

(50%) 25

(37%) 9

(13%) 0

(0%) 68

(100%)

46

Related Adverse Reactions GL-ONC1-005/UCSD

AE Term G1 (Mild)

G2 (Moderate)

G3 (Severe)

G4 (Life-

threatening)

Total

Fever 2 1 0 0 3

Vesicular skin lesions 2 1 0 0 3

Rigors 2 1 0 0 3

Fatigue 2 1 0 0 3

Dermatitis 2 0 0 0 2

Hypoalbuminemia 2 0 0 0 2

Chills 1 0 0 0 1

Headache 1 0 0 0 1

Superficial thrombosis 0 1 0 0 1

Hypotension 1 0 0 0 1

Nausea 1 0 0 0 1

TOTALS 16

(76%) 5

(24%) 0

(0%) 0

(0%) 21

(100%) 47

Related Adverse Reactions GL-ONC1-003/MSK

Toxicity Definite and Probable G1 G2 G3 G4 # patients

ALT x x 1

Alk phos x x 1

AST x x 1

Chills x 3

Fever x x 4

Flu like symptoms x 3

Headache x 1

Nausea x 1

Pain x 1

Sinus tachycardia x 1

Sweating x 1

48

Does virus shed?

49

Virus Analyses (by VPA) GL-ONC1-005/UCSD

Cohort Patient

Shedding Analysis (by VPA)

Screening Day 4* Day 5* Day 9* Day 10*

U OS U OS U OS U OS U OS

3x108

pfu

501 - - - - - -

502 - - - - - -

503 - - - -

1x109 pfu

504 - - - - - -

506 - - - - - -

507 - - - - - -

3x109

pfu

508 - - - - - -

510 - - - - - -

512 - - - - - -

3x109 pfu

x

2 doses

514 - - - - - -

515 - - - - - - - - - -

516 - - - - - - - - - -

517 - - - - - - - - - -

* Virus treatment on Day 3. U: urine; OS: oral swab Positive values are reported as pfu/300 µL of sample

No shedding of virus in urine or saliva in combination therapy

50

Viral Shedding is Minimal or None

Summary

No to very few viral shedding when delivered i.v., i.pe., or i.pl. No shedding in combination therapy

51

PK / PD

52

GL-ONC1 DNA IN BLOOD DAY(S) AFTER INJECTION - Subsequent Injections Have Similar PK Profile

GL-ONC1-002/MA

Cohorts with multiple doses per cycle

VACV A21L gene.

1

10

Cohort 6

Cohort 7

Cohort 8

Cohort 8a

Co

py N

um

be

r

Cycle 1 Cycle 2

53

Sustained survival & production of virus confirmed GL-ONC1-004/TUE

1,00E-01

1,00E+01

1,00E+03

1,00E+05

1,00E+07

1,00E+09

tota

l p

ful

total pfu of GL-ONC1 in peritoneal fluid of pt 401 (titration assay)

inoculation dosage = 1.0 E+07 pfu

peak >> 1.0 E+08 pfu

lavageascites

> 3 weeks of progeny virus production

viral

Viral output

(intraperitoneal virus replication)

54

Live Virus Re-isolated From Treated Patients GL-ONC1-004/TUE

ascitic fluid of patient #401 sampled on C1D8,

incubated on indicator CV1 cells for 1 day

(African green monkey kidney cells)

Phase contrast Fluorescence

10x, 5000 ms 10x

55

Inflammatory response after intraperitoneal virotherapy GL-ONC1-004/TUE

Cohorts with single dose per cycle Cohorts with multiple doses per cycle

Anti-vaccinia Antibody Levels Plateaued Early GL-ONC1-002/MA

i.v. route

1

2

4

8

16

32

64

128

256

512

1024

2048

Dilu

tio

n fo

r 5

0%

Neu

tral

izat

ion

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 5a

Cohort 5b

Cohort 1B

1

2

4

8

16

32

64

128

256

512

1024

2048

Dilu

tio

n fo

r 5

0%

Ne

utr

aliz

atio

n

Cohort 6

Cohort 7

Cohort 8

Treatment Stage Treatment Stage

57

Does virus infect tumor tissue/cells?

58

Pt. # Tumor type Cohort GFP IHC Viral Plaque Assay

1 MPM1 epithelioid 1 (-) (+) (+)

2 NSCLC2 1 (-) (-) (-)

3 MPM epithelioid 1 (-) (+) (-)

4 MPM epithelioid 1 (-) N/A (-)

5 MPM epithelioid 2 (-) (-) (-)

6 MPM epithelioid 2 (+) (-) (-)

7 NSCLC 2 (-) N/A

8 MPM epithelioid 3 (-) (-) (+)

9 MPM epithelioid 3 (+) (+) (-)

10 MPM epithelioid 3 (+) (+) (-)

11 MPM sarcomatoid 4 (-) (-) (-)

12 Breast cancer 4 (-) Pending (-)

1 MPM: Malignant pleural mesothelioma 2 NSCLC: Non-small cell lung cancer

GL-ONC1 Effectively Infects Mesothelioma Tumors

59

GL-ONC1-003/MSK

Positive virus-encoded GFP in Mesothelioma biopsy

Positive IHC of GL-ONC1 in Mesothelioma biopsy

GL-ONC1 Effectively Infects Mesothelioma Tumors

60

GL-ONC1-003/MSK

H & N squamous cell carcinoma biopsy (Pt. 204 - C4D15)

Viral Colonization in Tumor Biopsy Confirmed by IHC GL-ONC1-002/MA

i.v. route

61

UDA= User defined Assay. GFP signal detection.

Virus-infected CTC

Virus-infected CTC

Patient 127 - C1D8 Colorectal cancer with liver metastases

GFP+ CTCs were also found in pt. #129, 135, 136, & 305

CTCs were Infected by GL-ONC1 Virus - Confirmed by GFP imaging (real-time monitoring of therapy)

GL-ONC1-002/MA

62

Evidence of antitumor activities & clinical benefits

63

Diagnosis Cohort

#

Dose Conc. in

pfu/cycle

# of

Cycles

# of Known

Wks of Stable

Disease (SD)

Met. Hurtle cell carcinoma thyroid, lung 1 1 × 105 6 24

Parotid adenocystic tumor, lung mets 2 1 ×106 6 12

H & N squamous cell carcinoma, lung mets 3 1 ×107 8 24

Esophageal carcinoma 5 1 × 109 6 24

Colorectal carcinoma, lung mets 5 1 × 109 5 12

H & N squamous cell carcinoma, lung mets 6 5 × 107 5 12

Myxoid chondrosarcoma, multiple lung mets 7 5 × 108 6 48

Colorectal cancer (adenocarcinoma), liver

metastases 5a 1 × 109 1 8

Metastatic renal cell carcinoma, lung mets 5b 3 × 109 5 12

Cholangiocarcinoma 8 5 × 109 5 12

NSCLC 8 5 × 109 5 12

Adenocarcinoma of the appendix 8b 5 × 109 8 13

Esophageal carcinoma, lung mets 8c 5 × 109 6 13

13 of 27 Evaluable Pts with Stable Disease

SD based on CT scans 64

GL-ONC1-002/MA

Pre-treatment

Post-treatment

GL-ONC1 (Ch 8) Cholangiocarcinoma

Tumor growth slowed

Treatment Benefit / Preliminary evidence of tumor response

65

Pt. 133 Tumor sizes

0

10

20

30

40

50

60

01/04/

2012

01/05/

2012

01/06/

2012

01/07/

2012

01/08/

2012

01/09/

2012

01/10/

2012

01/11/

2012

Tum

or

lon

gest

dia

me

ters

(m

m)

Pre-treatment

Post-treatment

MAPPING study (Pazopinib vs placebo)

GL-ONC1 (Ch 8)

NSCLC

Tumor growth slowed

Treatment Benefit / Preliminary evidence of tumor response

66

• 43-yr old man; metastatic mucinous adenocarcinoma of the appendix and progressive peritoneal bowel disease;

• Tolerated 8 cycles of viral treatment (4 × 1010 pfu of GL-ONC1 total);

• Clinical signs of treatment benefit reported by Patient & Physician:

Reduction in abdominal pain: 6-8 hrs 2-3 hrs;

Reduced pain medication;

Soften of abdominal mass by palpation.

• Additional GL-ONC1 treatment given:

Dr. Mazhar Ajaz to UK’s GTAC: “The patient has been desperate to continue

beyond his scheduled six cycles of treatment because of the perceived benefit.”

Patient is still alive at last time of contact.

Cohort 8b Pt. 307: Treatment benefit observed

- 5 x 109 pfu: Highest dose of single i.v. infusion

67

Overall survival of patients in SD vs. PD group GL-ONC1-002/MA

0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

40.00

Nu

mb

er o

f M

on

ths

Evaluable Patients in Phase I, Phase IB & 8

Overall Survival in months as of 12-Feb-14

PD

SD

OS (mons)

PD Mean 7.73 Median 7.82

SD Mean 14.40 Median 10.99

Remission

0 5 10 15 20 25 30 35 40

0

20

40

60

80

100

OS Time in Months

Su

rviv

al p

rob

ab

ility

(%

)

Group

PD

SD

68

As of Oct.9, 2014

GL-ONC1-005/UCSD: BEST OVERALL RESPONSES

Ch Pt. # Disease Type HPV Stage BOR at Wk 23

(PET/CT)

Duration of BOR

(mos)

Current Status

OS Time in mos as of Oct.9, 2014

1

501 Base of tongue, squamous carcinoma Negative IV A CR 28.1 CR 28.1 mos & ong. 502 Hypopharynx, squamous carcinoma Negative IV A CR 13 PD 26.6 mos & ong.

503 Paranasal sinus, adenoid cystic carcinoma

Negative IV B PR @ 6m 23.7 Min. disease 23.7 mos & ong.

2

504 Glottic larynx Negative IV A CR 21.7 CR 21.7 mos & ong

506 Nasopharynx Negative IV B CR 18.9 CR 18.9 mos & ong.

507 Hypopharynx Negative IV A PD 4 Deceased 17.5 mos & ong.

3 508 Hypopharynx, squamous carcinoma Positive IV A CR 18.8 CR 18.8 mos & ong. 510 Hypopharynx, squamous carcinoma Negative IV A CR 16.7 CR 16.7 mos & ong. 512 Supraglottic larynx, squamous carcinoma Negative IV A CR 16.3 CR 16.3 mos & ong.

4

514 Larynx Negative IV A PR 4 Deceased 8 mos 515 Neck mass of unknown primary origin Positive IV A CR 15.4 CR 15.4 mos & ong. 516 Oropharynx carcinoma Positive IV B CR 13.8 CR 13.8 mos & ong. 517 Neck mass of unknown primary origin Positive IV A PR 9.1 PR 9.1 mos & ong.

518 Cancer of parotid gland Negative IV B N/A 4.9 Deceased 4.9 mos

519 Tongue, squamous carcinoma Negative IV B PR at W 15 In FU (D 150) PR 5.0 mos & ong.

5 521 Supraglottic larynx, squamous Negative IV A Pending In FU (D 129) Pending 4.4 mos & ong.

522 Tongue, squamous carcinoma Negative IV A Pending In Tx (D 24) Pending 0.9 mos & ong.

Red - Pending Green – CR (complete response) HPV – Human papillomavirus PR – partial response Black - PD (progressive disease) BOR – best overall response

Clinical Response – 501 (Base of Tongue)

Baseline 3 Mo Post-Treatment

Baseline 4 Mo Post-Treatment

Endoscopy

Imaging

70

Clinical Response – 502 (Hypopharynx)

Baseline 3 Mo Post-Treatment

Baseline 4 Mo Post-Treatment

Endoscopy

Imaging

71

Patient 503: ● 77 yr-old woman; ● diagnosed on 9/11/12 with adenoid cystic carcinoma, paranasal sinus; ● Stage IVB, HPV–; T4B N0 M0.

Treatment:

• Received first RT+Cisplatin on October 29, 2012.

• 3 × 108 pfu GL-ONC1 i.v. on October 31, 2012.

• Completed the trial per protocol on April 3, 2013.

• Week 23 CT on April 3, 2013 showed partial response (PR)

72

CASE STUDY: UCSD PATIENT (503) – HPV NEGATIVE: CONVERSION FROM PARTIAL TO COMPLETE RESPONSE

Baseline

4-mo PET/CT

Tumor

Baseline PR @ Week 23

Minimal Disease @ Month 16.5

March 5, 2014: 16.5 mo. from enrollment, and no further treatment, patient showed only minimal disease. Conversion from Partial to Complete Response

CASE STUDY: UCSD PATIENT (503) – HPV NEGATIVE: CONVERSION FROM PARTIAL TO COMPLETE RESPONSE

Cohorts & Pt. #

Mesothelioma subtype

Baseline Disease Status (prior Tx)

Post-GL-ONC1 Other Anti-cancer

Survival Status

OS since Date of Diagnosis (Mos)

1

001 epithelioid Newly diagnosed Surgery; RT + Chemo Alive 21.5

003 epithelioid Newly diagnosed None Alive 20.8

004 epithelioid Newly diagnosed Chemo + RT; Surgery Alive 17.3

2

005 epithelioid Newly diagnosed Surgery;

Chemo + RT Alive 16.6

006 epithelioid Newly diagnosed Surgery; Chemo

Alive 17.3

3

008 epithelioid Newly diagnosed Chemo + RT Alive 15.5

009 epithelioid Newly diagnosed Chemo + RT Alive 14.6

010 epithelioid SD

(Carboplatin, Pemetrexed)

None Alive 14.6

Median For epithelioid

17.0

4 011 sarcomatoid Newly diagnosed N/A Deceased 3.7

014 biphasic Newly diagnosed None Deceased 6.1

Survival of Mesothelioma Pts

As of Oct.23, 2014 74

Antitumor activity shown in “fluid” biopsy - Analyses of ascites or peritoneal lavage

% of total cells Day 4 Day 8 Day 22 Day 59

Tumor cells 5 % < 2 % 0 % 0 %

Virus-infected tumor cells 5-10 % 90 % 0 % 0 %

At C1D8 significant reduction of ascitic malignant cells; increased % of GL-ONC1 infected tumor cells

Following C1D22 no longer detection of tumor cells in peritoneal lavage

GL-ONC1-004/TUE

Example:

75

Summary of Key Considerations (all human trials)

Safety:

Multiple doses of GL-ONC1 treatments delivered by different routes are well tolerated (294 infusions in 83 patients)

5 × 109 pfu single i.v. dose in human pt. well tolerated

MTD not reached in any of the trials

Shedding: Minimal to none

Systemic & regional delivery: Yes

Infection of tumor tissue/cells: Yes

Antibody response: Yes; plateau rapidly (i.v.)

Infectivity of baseline tumor biopsy in petri dish: Yes

Antitumor response: Yes, clinical benefit also observed

76

GL-ONC1

Oncolysis

Innate & Adaptive Immune

Activation

Dual-Mechanism of Action: Tumor cell lysis and activation of antitumor immunity

77

The Potential of Immunotherapy

Has the potential to achieve complete, long-lasting remissions and cancer cures, with few or no side effects, and for any cancer patient, regardless of their cancer type. - www.cancerresearch.org

78

Cancer Immunotherapy - the New Movement

Cancer immunotherapy—treatments that harness and enhance the innate powers of the immune system to fight cancer—represents the most promising new cancer treatment approach since the development of the first chemotherapies in the late 1940s. - www.cancerresearch.org

“Immunotherapies will likely become the treatment backbone in up to 60% of cancers over the next 10 years compared with <3% today.” Andrew Baum, MD Citigroup Global Health

Immunotherapy -The Beginning of the End for Cancer: Transforming Cancer into Chronic Disease

79

• Sophisticated clinical trial design

• Rich discovery and pre-clinical pipeline

• Robust intellectual property portfolio

• Diversified strategic opportunities

Genelux is Poised for Success

Our mission is to deliver a powerful, targeted and sustained attack on cancer …wherever it may reside

80

Illuminating Hope in the Fight Against Cancer

Thank You!

38