Verona Pharma : VRNA Presentation November 2024

Published: 2024-11-04 08:30:14 ET VRNA

World COPD Day

20 November 2024

#COPDAWARENESS

Developing innovative therapies for the treatment of respiratory diseases

November 2024

Nasdaq: VRNA | www.veronapharma.com

Strong financial position to support company growth

Future draws up to $425M provide optionality beyond 20261

$5.6M

($43.0M)

Net revenue

Net income

September 30, 2024

$336.0M

$2.9B2

Cash and

Market Cap

equivalents

(Nasdaq: VRNA)

September 30, 2024

November 1, 2024

Potential future draws

1 - Runway expectations based on cash and equivalents as of September 30, 2024, and future draws on Oaktree/OMERS debt facility and RIPSA. 2 - Approximately 81.8M ADSs outstanding as of as of October 28, 2024 (equivalent to ~ 654.6M ordinary shares).

3 - Repayment capped at 1.75x of the amount funded.

Verona Pharma's respiratory product pipeline

Ensifentrine provides multiple product opportunities

Product

Indication

Pre-clinical

Phase 1

Phase 2

Phase 3

Approved/

Available

Maintenance

treatment of COPD

Ensifentrine

Non-Cystic Fibrosis

(Nebulizer)

bronchiectasis

Cystic Fibrosis

Asthma

Ensifentrine + LAMA

Maintenance

(Nebulizer)

treatment of COPD

Maintenance

treatment of COPD

Ensifentrine

Asthma

(DPI / MDI)

Cystic Fibrosis

LAMA: Long-acting muscarinic agent

4 DPI: Dry powder inhaler, pMDI: Pressurized metered-dose inhaler

Ohtuvayre is available for the maintenance treatment of COPD in adult patients

Label supports broad use in COPD patients

Broad Use / Novel MOA

Pre-commercial activities set the stage for rapid launch

Commercial team / infrastructure driving Launch

First inhaled COPD treatment providing bronchodilation and

non-steroidalanti-inflammatory effects

Ohtuvayre prescribing information

Ensifentrine: Novel selective inhibitor of PDE3 and PDE4

Downstream bronchodilation and non-steroidalanti-inflammatory effects

PDE3 and PDE4 enzymes are present in lung cells associated with COPD pathology:

Selective inhibition of PDE3 and PDE4 results in accumulation of intracellular levels of signaling molecules, cAMP and cGMP

Ensifentrine INHIBITION

This mechanism of action produces:

cAMP = cyclic adenosine monophosphate; cGMP = cyclic guanosine monophosphate; PDE3 = phosphodiesterase 3; PDE4 = phosphodiesterase 4.

1Calzetta L, et al., J Pharmacol Exp Ther. 2013;346(3); 2Calzetta L, et al., Pulm Pharmacol Ther 2015;32:15-23;3Matera MG, et al., Am J Respir Crit Care Med 2013;187:A1495;

4Venkatasamy R, et al., Br J Pharmacol 2016;173(15):2335-2351;5Boswell-Smith V, et al., J Pharmacol Exp Ther 2006;318(2):840-848;6Franciosi LG, et al., Lancet Respir Med

2013;1(9):714-727;7Schmidt D, et al., Br J Pharmacol 2000;131(8):1607-1618;8Turner MJ, et al., Am J Physiol Lung Cell Mol Physiol 2016;310(1):L59-70

Phase 3 data published in American Journal of Respiratory and Critical Care Medicine

Endpoint

ENHANCE-1 (N=760)

ENHANCE-2 (N=789)

Average FEV1 AUC (0-12 hours)

+87 mL (p<0.0001) vs placebo

+94 mL (p<0.0001) vs placebo

Peak FEV1

+147 mL (p<0.0001) vs placebo

+146 mL (p<0.0001) vs placebo

Morning Trough FEV

+35 mL (p=0.0413) vs placebo

+49 mL vs placeboa

Symptoms (E-RS Total Score)

-1.0 units (p=0.0111) vs placebo

-0.6 units vs placebob

Quality of Life (SGRQ Total Score)

-2.3 units (p=0.0253) vs placebo

-0.5 units vs placebob

Exacerbation rate

36% reduction in ratec

43% reduction in ratec

Time to first COPD exacerbation

38% reduction in riskc

42% reduction in riskc

Incidence of adverse events

Back Pain 1.8% vs 1.0%

Hypertension 1.7% vs 0.9%

(AEs ≥1% and greater than placebo)

UTI 1.3% vs 1.0%

Diarrhea 1.0% vs 0.7%

UTI = Urinary tract infection

1Anzueto A, et al. Am J Respir Crit Care Med. 2023;208(4):406-416;2Barjaktarevic I, et al. Am J Respir Crit Care Med. 2023;207:A5008

Pipeline expansion : Non-cystic fibrosis bronchiectasis (NCFBE)

Chronic disease marked by recurrent infection and progressive lung damage

~370,000 US Patients1,2

Ensifentrine Targets Neutrophilic Inflammation,

No Approved Treatments

Impacts Exacerbations & Key NCFBE Symptoms

Key Issues

Unmet Needs

1Prevalence calculated by US Census data and prevalence rate of NCFBE; 2Non-Cystic Fibrosis Bronchiectasis (NCFBE) Market Insights, Epidemiology and Market Forecast -

82032, Delveinsight

Bronchiectasis Phase 2 Design

4 weeks

Screening Period

1:1

≥ 24 weeks

Treatment: Nebulized ensifentrine 3 mg BID + SOC (n=90)

Treatment: Nebulized placebo BID + SOC (n=90)

Clinic Visits Day 1, Weeks 6, 12, 18 and 24; every 8

weeks until end of study/EOT

1 week

Off-

Event driven design,

treatment

80% power to detect

Off-

a hazard ratio = 0.6

treatment

Day 1 (baseline) Randomization

EOT

EOS

Primary endpoint: Protocol-defined pulmonary exacerbation rate

Secondary endpoints:

9CAAT: Chronic Airways Assessment Test; EOS: End of study; EOT: End of treatment; E-RS: Evaluating Respiratory Symptoms; QoL-B: Quality of Life Bronchiectasis; SGRQ: St.

George's Respiratory Questionnaire; TS: Treatment start; V: Visit

Pipeline expansion: Fixed dose combination

COPD market has progressed to combination products to maximize efficacy given chronic, progressive disease

Rationale for Ensifentrine + Glycopyrrolate

Phase 2 program design supports dose

selection for Phase 3

1Calzetta L, et al. Pulm Pharmacol Ther. 2015 Jun;32:15-23; Calzetta L, et al. J Pharmacol Exp Ther. 2013 Sep;346(3):414-23.2Spiriva Respimat; Ferguson G, et al. Int J Chron

Obstruct Pulmon Dis. 2021 Apr 22;16:1137-1148;3Siler, T M, et al. CHEST. 2023 Oct 1;164(4):A4952-4

Disclaimer

Verona Pharma plc published this content on November 04, 2024, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on November 04, 2024 at 13:29:09.093.