ARVELLE THERAPEUTICSINNOVATIVE TREATMENTS FOR EPILEPSY AND CNS DISORDERS

• Approximately 40% of patients with epilepsy are drug-resistant* after two different anti-seizure medications (ASMs)[3–5]

• Despite the many ASMs on the market, outcomes for patients with epilepsy have not drastically changed for more than two decades[3,6]

• There is an urgent need for more effective treatments[1,2,7,8]

"WE BELIEVE CENOBAMATE HAS THE POTENTIAL TO BE AN IMPORTANT ANTI-SEIZURE MEDICATION FOR ADULT PATIENTS SUFFERING FROM FOCAL ONSET SEIZURES."

MARK ALTMEYERFOUNDER, CHIEF EXECUTIVE OFFICER

There are an estimated six million people in Europe with epilepsy of which about 3.6 million are living with focal onset seizures.[1,2]

We are Arvelle Therapeutics. Our mission is to bring innovative solutions and new therapies to patients with epilepsy and other CNS disorders.

DEDICATED TO INNOVATIVE THERAPIES. COMMITTED TO BETTER PATIENT OUTCOMES.

INVESTIGATIONAL TREATMENT

Headquartered in Zug, Switzerland, Arvelle is focused on bringing cenobamate, an investigational ASM, to market. Arvelle licensed the exclusive right to develop and commercialise cenobamate in Europe from SK Biopharmaceuticals. The Marketing Authorisation Application (MAA) for cenobamate as adjunctive treatment for uncontrolled focal onset seizures in adults with epilepsy is currently under the European Medicine Agency (EMA) evaluation. Following the potential EMA approval, Arvelle plans to commercialise cenobamate as early as mid 2021.

Cenobamate is a potential novel ASM with a unique, dual, complementary mechanism of action:

• Enhances inhibitory currents through positive modulation of GABAA receptors at a non-benzo-diazepine binding site[9]

• Decreases excitatory currents by both inhibiting the persistent sodium current and enhancing the inactivated state of voltage-gated sodium channels[10]

Arvelle has filed a Marketing Authorisation Application for cenobamate. Cenobamate is currently not approved for use in Europe. Nothing in this brochure is intended to promote cenobamate.

1. Cross JH. Epilepsia 2011;52(1):187–188. 2. Schmitz B, Montouris G, Schäuble B, et al. Epilepsia 2010;51(11):2231–2240. 3. Chen Z, et al. JAMA Neurol 2018;75(3):279–286. 4. Kwan P and Brodie MJ. N Engl J Med 2000;342(5):314–319. 5. Kwan P, et al. Epilepsia 2010;51(6):1069–1077. 6. Costa J, et al. Epilepsia 2011;52(7):1280–1291. 7. French JA. Epilepsia 2007;48(Suppl 1):3–7. 8. Laxer KD, et al. Epilepsy Behav 2014;37:59–70. 9. Sharma R, et al. Eur J Pharmacol 2020;879:173117. doi: 10.1016/j.ejphar.2020.173117. 10. Nakamura M, et al. Eur J Pharmacol 2019;855:175-182. doi: 10.1016/j.ejphar.2019.05.007.

*Defined by ILAE as failure of two appropriately selected, used and tolerated ASM regimens.

ASM: anti-seizure medication; CNS: central nervous system; ILAE: International League Against Epilepsy MAA: Marketing Authorisation Application.

PIPELINE

Arvelle Therapeutics has filed a MAA for cenobamate in adult focal onset seizures. Registrational studies are ongoing in patients with primary generalised tonic-clonic seizures. Further trials are planned to study cenobamate in paediatric patients with epilepsy. Arvelle also plans to study cenobamate in non-epilepsy indications such as bipolar disorder, neuropathic pain and anxiety disorders.

Programme Indication Status Timeline

1 2 3 Regulatory

Focal Onset Seizures

Bipolar Disorder

Primary Generalised Tonic-Clonic Seizures

Neuropathic Pain

Paediatric / Orphan

Anxiety Disorders

Epilepsy

Non-Epilepsy

MAA filed

Under evaluation, programmes could begin in late 2020

Expected to complete in 2022

Expected to initiate in 2020

CENOBAMATE

OPPORTUNITY

Arvelle brings together dedicated individuals, driven by a passion to improve the lives of patients. That passion comes from an intimate knowledge of both the clinical and business sides of the biopharmaceutical industry.

LEADERSHIP TEAM

"WE WILL CONTINUE TO PARTNER WITH THE EPILEPSY AS WELL AS THE BROADER CNS COMMUNITY IN EUROPE AS WE WORK TO BRING POTENTIAL THERAPEUTIC OPTIONS TO PATIENTS."

ILISE LOMBARDO, MDFOUNDER, CHIEF MEDICAL OFFICER

ILISE LOMBARDO, MDFOUNDER, CHIEF MEDICAL OFFICER

llise Lombardo, MD is a Founder and the Chief Me-dical Officer of Arvelle. Ilise has around 20 years of experience leading clinical development and medical affairs programs across multiple therapeutic areas including neurological and psychiatric disorders.

GREGORY WEINHOFF, MDFOUNDER, CHIEF FINANCIAL OFFICER & BUSINESS OFFICER

Gregory Weinhoff, MD is a Founder, Board Member and Chief Financial Officer and Chief Business Officer. He has more than 20 years of experience in healthcare finance and operations as a venture capital investor and operating executive.

Mark Altmeyer is a Founder, Board Member and the Chief Executive Officer of Arvelle. Mark has 30 years of experience leading successful drug commercialisation efforts as a pharmaceutical executive, with a focus on therapies for CNS disorders.

MARK ALTMEYERFOUNDER, CHIEF EXECUTIVE OFFICER

Petra Molan is a seasoned healthcare professional with over 20 years of pharmaceutical commercialisa-tion experience. Before joining Arvelle, Petra was SVP, Global Head of Rare Hematology Franchise, Patient Value & Product Strategy at Takeda Pharmaceuticals.

PETRA MOLAN, PHARMD, M.S.C.SENIOR VICE-PRESIDENT (SVP) COMMERCIAL

Enrico brings more than 20 years of international private practice and in-house legal experience in both large and mid-size pharmaceutical companies to the company. Before joining Arvelle, he served as VP of International Legal Affairs for Sarepta International Holdings where he partnered cross-functionally to accelerate the company’s expansion in both traditional and emerging markets.

ENRICO DOLFINIVICE PRESIDENT (VP) LEGAL COUNSEL

Luca Rota is an accomplished human resources executive with 20 years experience in the health-care, biotechnology and pharmaceutical industries. Prior to joining Arvelle, Luca served Shire Pharma-ceuticals as the Global Head of HR for the Product Strategy and Sales & Marketing teams, and the HR Site Lead for their international HQ.

LUCA ROTAVICE PRESIDENT (VP) HUMAN RESOURCES

Arvelle Therapeutics International GmbH | Zählerweg 6 | 6301 Zug | Switzerland | +41 (44) 567 294 0info@arvelletx.com | www.arvelletx.com