Aromics

MainImage

286,945.27€

Out of 300,000.00€

investors

35

Est. ROI

614%

days left

2

Developing a novel treatment for malignant mesothelioma

Finish date: 31/03/2017 Barcelona

Premoney valuation

5,000,000.00€

Percentage offered

5.66%

Est. ROI

614%

Exit horizon

2021

The project

About us: Our proposal

AROMICS (www.aromics.es) is a privately-owned development stage pharmaceutical company founded in 2005, based in Barcelona and focused on developing novel first-in-class therapies for the treatment of human diseases. The company has already achieved different R&D awards from international, European, national and local public organizations (European Union, NCI, NIH, ICEX, CDTI, ENISA, ACC1Ó and MINECO). Our focus of interest is oncology and infectious diseases. As a result of our intensive R&D activity over the last years, the company received last year the seal of Innovative SME from MINECO.

The business model is to move validated inventive findings (protected under granted patents) up to early clinical stages (first-in-man efficacy Phase II). After completing clinical efficacy proof is foreseen a licensing out, co-development agreement or direct product sale to pharmaceutical industry. Revenues will come from dealmaking usually including upfront and milestone payments and royalty tiers.  Usual multiply factor for similar investments are of x6.

Our most advanced  antitumor drug candidate

Most advanced candidate in our pipeline is NAX035, a first-in-class, selective and potent compound for the treatment of cancer. The novel drug is currently completing regulatory preclinics compelling all the data required by the European Medicine Agency, seeking the approval for conducting Phase IB/II (safety and efficacy) clinical testing in patients.

Malignant mesothelioma has been selected as first indication for NAX035 to proceed into clinics due to the potency exhibited by the compound in this tumor type including both, pleural and peritoneal cancers.  If effective, NAX035 will suppose a clear advance in the treatment of this rare cancer.

 

Malignant mesothelioma is a rare and aggressive occupational cancer linked to asbestos exposure, with a clear need of effective compounds

Malignant mesothelioma is an aggressive tumor arising in the lining cells (mesothelium) of the pleural and peritoneal cavities, as well as in the pericardium and the tunica vaginalis. With a natural history of 7 to 9 months if untreated and less than five per cent 5-years survivors, is a bad prognosis tumor representing currently 0,3% of total cancer deaths. 

 

Malignant mesothelioma is an occupational cancer

 

The World Health Organization (WHO) has recognized that all forms of mesothelioma are strongly associated with exposure to asbestos, a group of minerals presents in nature highly resistant to heat and corrossion. Due its physical properties, asbestos was widely used by the industry including: construction, minery, navy, textile, motor or plumbery among others. However, the use was limited some decades ago, being a material currently banned in fifty countries, as it is considered as a first level carcinogen.

Moreover, in those countries were has been already prohibited like EU, asbestos remains still a challenge as there are still many buildings and industrial elements containing asbestos that require removal and disposal. A high cost removal plan that also puts workers and the community at immense risk. WHO estimates that around 125 million people are currently professional and environmental exposed. From them 10% eventually develop mesothelioma. Currently, more than 100,000 people die due to asbestos. The burden of asbestos-related disease will keep rising over the next years.

Therefore, "asbestos still represent a serious labour, public health and environmental problem".

 

 

Business opportunity

Why invest?

Malignant mesothelioma is a highly-resistant tumour

Current treatment includes surgery, radiotherapy and chemotherapy. Surgery is the most effective option, although unfortunately aproximately 85-90% of patients are diagnosed at advanced stage where the disease is inoperable, and thus the treatment palliative. Survival time is of 6-12 months with a response rate to chemotherapy in advanced stage that do not exceed 50%. For this reason, we are looking for a new therapeutic strategy that substitutes the current treatment.

The new agents in development include targeted therapies, monoclonal antibodies and immunoncologicals. None of them has exhibited yet superiority versus the standard of care. It is mandatory to find new and efficient treatments for the tumor, both as first and second-line therapy.

NAX035, first candidate advancing to clinics

NAX035 is a small molecule that has shown efficacy in front a variety of tumors of different origins including the most prevalent types of malignant mesothelioma (pleural and peritoneal) both, in vitro (in tumor cell lines derived from human sensitive and resistant tumors to pemetrexed-cisplatin therapy) and in vivo (in experimental xenograft mice) when it is administered orally or endovenously. Moreover, it exhibited an appropiate safety and tolerability profile in experimenatl animals. The compound is easy to manufacture at an affordable cost, which is important for future market penetration.

Drug is currently completing preclinical package. Its pharmacologican and easy synthesis, make of NAX035 a good candidate for the treatment of cancer.

Malignant mesothelioma is a rare disease, and therefore, NAX035 represents a potential orphan drug. Working over an orphan designation confers certains advantages to small companies like AROMICS:  it will suppose 7 years of market exclusivity, less development costs mainly due to the fact that clinical trials require less number of patients due to the rarety of the disease, less development time (in average 3.9 years for an orphan drug compared to 5.4 years for non-orphan drug), less regulatory barriers, some tax benefits plus R&D supportinggrants.

Why does it represents a business opportunity?

  • 1. Investing at this development stage represents an invest in a "new platform/strategy for the treatment of a refractory cancer"
  • 2. Mesothelioma incidence is raising
  • 3. Current development will allow us not only a new treatment for malignant mesothelioma but also other asbestos-related tumors ( lung, larynx and gastrointestinal among others). The investment will have a multiplier effect..
  • 4. AROMICS has already succesfully developed with internal funds, a part of the preclinical development. The current drug supposes an advance up to clinics.

Investment & Exit

The estimated total cost for developing the first candidate up to efficacy in patients is about 6 million €. Three financial rounds are foreseen:

1ª.- A bridge round up to 500.000 euros for completing preclinical studies includin pharmacology and toxicology required for the regulatory agency to authorize the use of the drug in humans.

2ª.- A second round up to 2 million euros, to complete GMP manufacture and first-in-human trial (Phase IB: safety and dose range in patients)

3ª.- 3 million euros for Phase IIA (efficacy in patients)

  • What we require? CapitalCell crowdfunding

Our goal is to cover first part of this financial requirements with the goal to complete preclinical regulatory package, foreseen for the second quarter of 2017. Part of the 500,0000 euros required will be covered thru the crowdfunding with CapitalCell (300.000 euros at a minimum ticket of 1.000 euros), and will be completed with the co-investment of the current shareholders and the support of R&D grants already achieved by the company for the project

  • Why joining us?

AROMICS is a biotech company with a relevant number of R&D projects in different development stages characterized by a high innnovation capacity, novel technologies application and a sustained growing based upon the establishment of strategic allicances that has positioned internationally the company and allowed growing of new products of great potential for the pharmaceutical industry.

Exit Scenario

The business model is to move validated inventive findings up to early clinical stages (first-in-man) and licensing out to pharma companies that will drive the product up to the market. Revenues will come from dealmaking after clinical efficacy proof, Phase IB (safety and dose finding), or more typically after Phase IIA (efficacy in mesothelioma).

Return of investment. Exit strategy for the investors will usually be after completing a license out process, a co-development agreement or buy direct project selling with a Big Pharma company of the oncology sector once achieved the clinical milestone or by selling the product. 

Typical revenues will come from upfront and milestone payments, and royalty tiers. As previously mentioned, typical deals (source: Deloitte RECAP) at this development stage are expected to reach up to 500 Million € and subjected to up-front payments (typically around 25-50 Million €) followed by milestone payments to mark successes and royalties on sales (12-15%) if the product ultimately makes it onto the market.

Break event of the project,  will happen once completed the regulatory preclinical stage, and approval of the Regulatory Medicine Agency, at the entrance of first clinical test (Phase IB), where the financial round in foreseen. The different exit scenarios are depicted below:

  • First scenario of exit will happen in 18th months, once completed the regulatory preclinical stage, and approval of the Regulatory Medicine Agency, at the entrance of first clinical test (Phase IB): Exit will be for the negotiation of a license agreement or entrance of new investors for subsequent financial rounds.
  • A second scenario after completing the first proof-of-concept in humans. The goal is to find data amb the most effective dose and the safety of the drug. Being an oncology product, first in human trial includes cancer patients, and therefore it is possible to estimate first efficacy aspects. It is foressenstarting in 2018 to be completed by middle 2019.
  • Third and most common scenario, will be in 4-years after efficacy completion in patients (3Q 2020), by license or sale of the product.

 

 

 

Drivers

Dr. Carme Plasencia, Co-founder and Chief Executive Officer

  • Master Degree in Biotechology, completing Master in Busines Administration, Ph. D in Medicine and surgery at the Univeristy Autonomous of Barcelona and BSc in Chemistry with degree in Biochemtry from University of Barcelona 
  • Specialist in biochemistry, biomedicine, oncology, infectious diseases and molecular biology including the application of novel technologies in genomics, proteomics and cellomics in the research and development of novel drugs and diagnostic methods.
  • Dr. Plasencia has been part of multidisciplinary teams devoted to R&D programs in public and private research institutions at national and international level.
  • Current Member of different platforms around Europe including nanomedicine, innovative medicines, and biomarkers platforms among others.
  • Predoctoral scientist at Molecular Biology Laboratory of the Oncology Department of the Hospital Universitari Germans Trias i Pujol, where she got the PhD, specializing in the evaluation of novel anticancer agents and drug resistance mechanisms. 
  • Associate researcher of the Pharmaceutical Sciences Department, of the Pharmacy School at the University of Southern California /Norris Cancer Center in Los Angeles (California, USA), working in development of anticancer agents.
  • Several publications and books in scientific journals.
  • External evaluator of the European Union Commission at the Framework Program 6, 7 and Horizon 2020
  • Member of the scientific board of Current Molecular Pharmacology (Benthan Science)

Narcís Clavell, MBA, Co-founder, Financial Officer and Chairman of the Board

  • Master in Business Administration (MBA, IESE), Master in Information Technologies and Telecommunication Engineer.
  • Wide experience as enterprenour, in the creation and consolidation of its own companies, among them Ateknea Global Alliance with location in Catalonia, Malta, Hungary, Polonia and  Portugal, being currently the Chairman of the Board and founder.
  • Member of the Board of 10-15 small technology companies and research and development private centres in Europe.
  • Over 15 years experience in collaborative research  to implement novel technologies in the market, improving commercial activity and competitiveness of SMEs.

Immaculada Dalmau, co-founder and investor

  • Postgraduate in Pharmaceutical Industry
  • Wide experinece as advisor in pharmaceutical marketing.
  • From 1991 is working in commercial and marketing departments of different multinational companies from pharmaceutical sector and medical editorialsfarmacéutico.
  • Desde 1991 desarrolla su actividad laboral en departamentos de comerciales y de marketing en diferentes multinacionales del sector farmacéutico así como editoriales médicas multinacionales.

 

Partners & Associates

ADVISORY BOARD

Nancy J. Levy, Ph.D., Advisor in Business Strategy and Deals and licenses negotiation

  • —Founder and CEO of Biohealth Management Inc (Boston, MA, USA) 

  • Current member of the advisory board of different USA and European biopharmaceutical companies

  • Over 35 years experience in moving academic technologies to commercial  enterprises
  • Former CEO of Immunetics, Inc.
  • Former executive positions at Genzyme, Inc. and Millennium, Inc.
  • Dr. Levy collaborates with Aromics since 2007, in business development strategies, internationalization and strategic cooperation with american companies. Dr Levy has wide experience developing innovative R&D strategies up to market, leading pharmaceutical projects, connecting companies with investors and negotiating with public and private clients. Wide experience in advancing biotech developments from research up to clinics and negotiation of acquisition and licensing deals.

Werner Wolf, Ph.D., Advisor in Financial Strategy and Business Development

  • Owner and Chief executive officer of Bio Innovations, Ballwil, Switzerland.  Over 40 years experience in biotechnology and pharmaceutical sector.
  • Current board member of different biopharmaceutical companies
  • Wide experience (20+ years) as  former VicePresidents of R&D and R&D director at Boehringer Mannheim
  • Different executive positions at TVMCapital VCs (over 10 years).
  • European Union Advisor : Intellectual Property, Regulatory and development strategies.
  • Dr. Wolf collaborates with Aromics since 2012, advising the company in aspects related with the Business Plan and the Financial strategy for the development up to clinics of the different drugs in the pipeline of the company.

Paolo Lombardi, Ph.D. Medicinal Chemistry in Oncology Area Advisor

  • CEO and founder of Naxospharma
  • Graduated from Milan University, PhD from Southampton University.
  • Paolo has over 35yr experience in the pharmaceutical industrial setting and backgrounds in organic synthetic chemistry, process research chemistry, and medicinal chemistry.
  • Held several positions in Farmitalia Carlo Erba R&D where he achieved the goal of discovering Exemestane, launched in the global market under the name Aromasin™ for breast cancer therapy, and the clinical follow-up candidate Minamestane, as well as provinding the relative manufacturing chemical technology.
  • As Vice-president for Chemistry in Menarini Ricerche, Paolo fostered the discovery of Sabarubicin, a 3rd generation antitumour anthracycline presently in advanced clinical studies for Small Cell Lung Cancer (SCLC)
  • Inventor of over 50 patents, author and co-author of over 150 research papers, reviews, abstracts, invited lectures and seminars.Teaching appointments at Universities, Master courses & Specialist Schools.
  • Member of the American Chemical Society, Royal Society of Chemistry, Società Chimica Italiana, American Association for Cancer Research.
  • Dr Lombardi collaborates with AROMICS since 2011. His company (Naxospharma) and Aromics iniated a co-development agreeements as part of an European research project, BERTA - novel Berberine Derivatives as Antitumor Agents  -  Eurotransbio project, with a development cost of 733,000 €, partially financed in Catalonia by ACCIÓ and the Ministery of Economy in Italy. As a result of the project NAX035 was selected as first candidate to advance into cllinics.

 

Cristina Geroni, Ph.D. Advisor in preclinical and clinical development of novel antitumor agents and licensing  

  • Currently Board Member of Aesis Therapeutics.
  • Over 35 years at Oncology R&D drug development at different companies including Nerviano, Farmitalia, Pharmacia, Pfizer
  • Experienced on preclinical and clinical development an dlicensing-out oncology drugs
  • >55 patents on combination of antracyclines, topoisomerase inhibitors, taxanes, alkylating agents and CDK inhibitors currently in market

 

Current associated partners

AROMICS is also supported by prestigious scientists in the area of cancer and novel therapeutic developments:

  • lbert Abad, M.D., Ph.D.currently Chief of the Advisory Oncology (UCCO), and Chief of the Department of Medical Oncology of the Sanitas Hospitals. Previously Chief of Department of Medical Onocology at the Hospital Germans Trias i Pujol. Expert in digestive tumors.
  • Nouri Neamati, Ph.D.:  Professor at the University of Michigan, USA, Dr. Neamati is a worldwide recognized expert in the research of novel compounds for the treatment fo cancer, and the evaluation of molecular mechanisms involved in the efficacy and the resistance of the tumor to drug therapies.

Other coworkers include :

  • Regulatory Processes: collaboration with Asphalion in Spain and Smerud Clinical Research in Europa
  • Legal Process: collaboration with Innovatech Law firm, RCD and Ateknea Solutions Legal Department.
  • Intellectual Property Rights: Burns & Levinoson LLC, in USA and  Wachtershauser & Hartz in  Europa and ZBM in Spain.
  • Technology Transfer and Market Access: Health Innovation Technology Transfer (HITT) that is currently working with Aromics in advancing market access of current Aromics' pipeline.

Product/Service

NAX035 is an antitumor agent with proven activity in malignant mesothelioma

Current malignant mesothelioma treatments exhibit low efficacy, thus it is required to identify an optimal therapeutic option for this rare disease. NAX035, is the first candidate proposed by AROMICS to advance to clinics. It is a syntetic derivative of berberine, a natural, well tolerated and safety compound, widely used in Chinese and Ayurvedic medicine with properties as antibiotic, atifungal and anti-inflammatory drug. In fact, the alkaloid is being evaluated clinically for the treatment of diabetes and cardiovascular diseases. Its properties as antitumor agent are less evaluated, although there are already certain literature articles around its use for breast cancer therapy. As anticancer agent, the effect is ubiquous and the efficacy low. However, the chemical modification of the structure of the alkaloid renders selective, potent, and specific compounds for the treatment of cancer

This is the case of NAX035, a small molecule that exhibits high efficacy both in in vitro and in vivo experimental cancer models, appropriate pharmacological properties (ADME: absorption, distribution, metabolism and excretion) and a preliminary good safety and toxicology profile. First studies performed with NAX035 has shown oral efficacy in the treatment of aggressive and highly resistant tumors such as malignant mesothelioma (both, pleural and peritoneal tumours), a rare cancer, with 100,000 deaths per year and little therapeutic options.

The mechanism of action of NAX035 is highly innovative: the compound bounds directly to messanger RNA of Thymidylate Synthase protein, silencing the expression of the proteins that is involved in the cell duplication process, and therefore, in the tumor progression. The block of the protein expression leads the activitation of cell death by autophagy. The singularity of the mechansim, makesof  NAX035 the first compound of a novel anticancer class (“first-in-class").

Why is important in malignant mesothelioma? 

The overexpression of thymidylate synthase is being clinically related to drug resistance to the standard chemotherapy treatment (pemetrexed-cisplatin) used to treat the tumor. A drug resistance process that can be:

  1. Intrinsic: refractory patients prior to any therapy due to high levels of the proten present in the tumor. 50% of mesothelioma patients are non-responding
  2. Acquired: Drug resistance appears once initiated the treatment, due to the overexpression of the protein. Eventually all patients become refractory over treatment

Therefore Thymidylate Synthase protein levels is a predictive biomarker of response to Pemetrexed-based therapies. NAX035 is able to overcome this resistance and represents an alternative both as first, and second line of therapy.

Product

Product Profile

Name

13-(3,3Diphenylpropyl)-Berberine Chloride

Administration Route

Oral

Target

Thymidylate Synthase (TS or EC 2.1.1.45)

Type of molecule

Small molecule

Mechanism of action

Post-transcriptional control: inhibition of the aberrant expression of TS in the tumour cell.

Development achievements:

  • Completed early preclinical stages: efficacy (in vitro and in vivo) toxicology and preliminary safety (evaluation of maximum tolerated dose) in mice.
  • Initial product characterization (solubility, ADME profile and purity)
  • Completed active ingredient synthesis, and ready to transfer to scale up and GMP manufacturing process.
  • First draft to achieve orphan designation status.
  • On preparation of the Scientific Advice /protocol assistance: meetings for preclinical and clinical validation plan.
  • Regulatory guidance evaluation in Europe and USA
  • Evaluation of the compound in other solid and prevalent tumors like lung, ovarian and colorectal.

The whole development has been performed by AROMICS in Spain with the support of the Eurotransbio program  (partially financed by ACCIO – with a total project cost for AROMICS of 241.584,67€ ) and a pID  program from CDTI (total project cost of 329.551 €).

Intellectual Property

NAX compounds are currently being protected under granted patents in USA (US patent 8,188,109 B2, filed on 20.07.2009 and granted in US in May 2012) and Japan (JP 5,778,145 B2 patent granted in September 2015) entitled BENZOQUINOLIZINIUM SALT DERIVATIVES AS ANTICANCER AGENTS. Patent extensions include European Union (approved in November 2016) and International submissions (Canada, Australia and NewZeeland) filed beginning 2012, still pending. The patent is property of an Italian company (Naxospharma s.r.l.) to whom AROMICS maintain a strategic collaboration since 2011.

Aromics retains the rights over the Spanish patent and also an exclusive and worldwide license for the development of NAX035 compound and analogues  for the treatment of all cancer indications. The license contract is adapted to the entry of private and risk investment capital.   A novel patent for a specific indication and/or future patent extensions around NAX035 technology (production methods and/or pharmaceutical compositions) is expected in brief. Patent strategy (around newer patent, extension of existing patent and use patents) will be worked out during the project lifetime.

Market

Market Size

With an incidence of approximately 1.6 - 1.1/100,000 cases/year in Europe and USA, respectively, malignant mesothelioma is considered an “orphan disease” thus by definition, a treatment developed for mesothelioma is considered an orphan drug. The US market size with 3,000 people diagnosed every year and 2,500 annual/death. Between 1999-2010, it has been estimated 31,000 deaths related with the tumor. Since then, the number of affected people increases 5.4% yearly.

Without novel agents over the last 10 years, the global market for mesothelioma is valued in $210 million in 2015 with an annual growth rate of 4.1% raising up to $263 million by 2023.

The market is dominated by the sales of Alimta (pemetrexed),  direct mesothelioma sales of $190 million in 2015 ( of total sales of $2,7 billion including also lung cancer). The lack of efficacy of Alimta in malignant mesothelioma  and its current use anticipates the willingness to pay for introducing in the market novel and effective treatments for this orphan indication.

Marketing & sales

La estrategia de desarrollo de Aromics se basa en un doble pilar: acabar el desarrollo de NAX35 y al mismo tiempo posicionar esta y otras moléculas parecidas para el abordaje de cánceres igual de agresivos pero mucho mas frecuentes (como Pulmón, ovario, páncreas o colorectal.

Es por este motivo que contemplamos al mismo tiempo la licencia o venta de los desarrollos de la compañía y al mismo tiempo seguimos creciendo en la búsqueda de fuentes de financiación.

Naturalmente, los destinatarios de nuestros desarrollos deben ser compañías farmacéuticas que quieran invertir en el sector, que quieran seguir siendo actores relevantes o que quieran mantener posiciones de liderazgo.

Más adelante explicamos los posibles puntos de salida, pero siempre se producirán después de la consecución de hitos relevantes en el desarrollo del producto (PK/PD, estudio Fase I, estudio en Fase II). Estos acuerdos suelen organizar el pago en forma de un up-front (un pago inicial), pagos por hitos en el desarrollo y royalties en procentaje sobre las ventas si el producto llega al mercado.

Roadmap

Para alcanzar la prueba en humanos, el desarrollo constará de las siguientes etapas:

  1. Caracterización del ingrediente activo (API), fabricación GMP y desarrollo de formulación del fármaco: La formulación final del fármaco (pastilla) según norma de farmacopea.
  2. Finalización etapa preclínica de acuerdo a las normas regulatorisa: La estrategia regulatoria tras reunión EMA incluyen finalizar los estudios de PK/PD, toxicología GLP en dos especies animales. Los distintos proveedores ya han sido identificados.
  3. Solicitudes a las autoridades EMA y FDA: Este es un proceso burocrático por el que AROMICS solicitará permiso para hacer investigación clínica con sus productos. Este proceso lo llevará a cabo la una empresa especialista subcontratada y será supervisada por dos scientific advisors especialistas en la materia que forman parte de la plantilla de AROMICS. Así mismo ya se han establecido los contactos pertinentes con los centros hospitalarios para el estudio (Madrid y Barcelona) así como la CRO (organización de desarrollo clínico) que conducirá el estudio clínico.
  4. Designación Huerfana, y Scientific Advice and Protocol Asssitance. La estrategia regulatoria y clínica serán validadas por reunión con las agencias del medicamento europea, española y la FDA americana. Dado qeu la compañía es promotora de un fármaco huérfano, y se trata de una SME, la EMA ofrece servicios de asesoría gratuitos y de fácil acceso que disminuyen el riesgo regulatorio, y que suelen indicar cuál es el camino regulatorio que ellos prefieren y cómo acceder a las fases de estudio humano. Igualmente, dado que se trata de un fármaco huérfano, el proceso regulatorio es un proceso centralizado por lo que todas las negociaciones hay que llevarlas a cabo en la EMA.
  5. Desarrollo clínico: prueba de concepto en humanos.  La estrategia clínica actualmente desarrollada en colaboración con asesores regulatorios externos incluye:
  • Fase IB: Enfocada a completar los datos sobre seguridad, tolerabilidad y selección de dosis de acuerdo a parámetros farmacocinética en humanos  (se evalúa relación de la dosis con la respuesta antitumoral).
  • Fase IIA: La eficiencia de NAX035 en pacientes con mesotelioma maligno en combinación con el estándar of care (pemetrexed+cisplatino).

 

Cronograma del proyecto

Una hoja de ruta centrada en alcanzar la prueba de eficacia en un tumor huérfano como el mesotelioma maligno con necesidad urgente de fármacos efectivos. Una vez probada esta eficacia en pacientes, AROMICS se centrará en desarrollar el fármaco para otros tumores prevalentes sobre los que ya ha iniciado las primeras pruebas:

Forecast

The development plan for the most advanced indication (malignant mesothelioma), including operational and patent costs, for the 2016-2020 period is being structured as follows:

Year 1:  1.050.000 €

  • To complete preclinical stage, including PK/PD, GLP toxicology and safety (*decission point: go/not go)
  • To complete product characterization and GMP active ingredient (API) synthesis
  • To acheive orphan designation
  • To prepare the Investigational Medicinal Product Dossier (IMPD) is the basis for approval of clinical trials by the competent authorities in the EU.regulatory documents.

Year 2:  + 1.000.000 €

  • Initiation of the Phase IB (safety) clinical study in tumors of different origins, with the goal of establishing safety profile and dose range in humans.
  • To complete drug formulation, and establish manufacturing control.s
  • Submission of the IMPD and the Clinical Trial Authorization (CTA) to initiate human clinical trials to the Medicine Agency.

Year 3:  + 1.700.000 €

  • Phase IB completed. First attempt to license agreement (first investment exit point).
  • Starting Phase II clinicat trial to evaluate the efficacy in malignant mesothelioma.

Year 4:  +1.400.000 €

  • Completing Phase II clinical trial. Second attempt for licensing agreement (second exit point)

Use of funds

Following figures exhibits the use of the funds and the possible exit points for the investor


 

Financials

An innovative SME

AROMICS  turns aroung its capacity of innovation  (over 60% of the budget is devoted to R&D activities)  and supported by its technological capacities to develop proof of concepts, to potentiate strategic alliances with other biotech companies for the codevelopment of novel products. Over the last 10 years, the company has capitalized on this expertise, being awarded numerous grants to work with consortia of organizations (for profit and non-profit institutions and research centers), to identify and validate targets, select and qualify leads, as well as complete proof-of-concept in vitro and in vivo studies and early toxicology and ADME studies, ultimately leading to INDs. working on this way, has allowed the company growing and mature its own product pipeline.  AROMICS is currently identifying and characterizing candidates and leads for drug targets to be used in oncology and  infectious diseases. Two of these compounds, a novel antiviral and a novel antitumor agent, are currently at preclinical stage.

All the activity of the company is reinforced by a wide network of collaborations worldwide, that include companies and research centres and hospital, that support the company on the development and commercialization of the products. Our commercial vision is driven by Biotech upside opportunities based on licensing, milestones and royalty agreements utilizing our intellectual property rights and prototypes, complemented by services for securing the growth of the company.

How our activites are being financed ?

the financial plan for the different R&D products of AROMICS has been financed by private investment of the enterprenours  (432K€) supported with R&D inicitaitves from different public national and international organisms  (>2Mn in 10 years of activity, that covered the initial steps of the development where risk was higher) soft and participative loans from CDTI and ENISA (966K€) and supplemented with R&D services to third parties that has contributed not only to the company finace but also the incorporation of technology inside the company. Until now, there is no external risk capital company, so AROMICS owns the 100% of its capital.

NAX035 project financing

Preliminary work on NAX035 development has been developed in collaboration with the italian company Naxospharma  with the support of publlic and private funds. These are the non-dilutive funds achieved by the project:

1. European Project  (EU)

  • Selection of active molecules (drug Discovery): Preliminary work of discovery of NAX drugs, was the work of Naxospharma within the European Framework Program 6,  FP6-  project LIGHTS, where the new family of chemical compounds was synthesized.
  • Selection of preclinical candidates (Lead selection): European Project Eurotransbio of AROMICS in collobaroation with Naxospharma and the Instituto Nazionale dei Tumori (Milán, expert in experimental and clinical models of peitoneal malignant mesothelioma) total budgetof 733,000 €. NAX035 was selected as first lead. The project for the catalan company was performed by the support of ACC1Ó.

2. Spanish project

  • Early preclinical program (Lead optimization and early preclinical stage):Individual R&D project from CDTI (pID)- MESO, granted to AROMICS with a total budget of 329.551 €.

 

Investment details

Current investors

 AROMICS is a 100% spanish company, privately owned. Current investors are the enterprenours. The investment so far isn 412.300 euros, and also has invested in 2015 and 2016, capital as participative loan to the society that will be converted in capital, when the present campaign is completed with the entrance of new investors.

Future investors

  • Crowdfunding round with Capital Cell:  300,000 euros.
  • Contacts with national and international investors for the clinical development

Investment Plan for the period 2016-2020:

  • Seed capital up to 500,000 euros to complete regulatory program and starte manufacturing scale-up, for the achievement of the orphan indicaiton.
  • Fist capital round up to 1,5 milion euros investment to advance in the therapeutic program of NAX035. The capital will be used to complete formulation and GMP manufacturing, the submissions of the IMPD and CTA to enter NAX035 into clinical trials.
  • Round of 4 milion euros to advance into clinical trials to achieve safety in hmans and clinical efficacy. This round will be structures in two parts according to specific milestones, in order to disminish the associated technical risk:
    • Complete phase IB clinical study. This clinical study establishes the safety and dose range for the drug in cancer patients. Once ended the study (second trimester of 2018), it is foreseen a first attempt of license, which supposes first exit point for the investor.
    • Phase IIA clinical study, in malignant mesothelioma patients, to prove efficacy in front standard treatment. At the end of Phase II A (foreseen 3rd trimester of 2019), it is foreseen the license, which supposes a second potential exit point for investor.
  • The capital rounds will be leveraged whenever possible, with financial instruments as R&D grants (Horizon 2020 Unión Europea, national and local programs) and participative loans.  On this regard,  AROMICS achieved in 2015, the seal of innovative SME with wide experience in R&D programs. In 10 years, the company has participated and lead over 20 projects supported by public organisms (EU, CDTI, MIneco and Acció among them). The project counts now with 4 R&D grants for the next two years, although none covered yet the clinical stages. .

    It is foreseen a retorn of the investment as soon as the proof of concept in humans is achieved thanks to license, codevelopment or direct project sale to pharmaceutical companies at the beginning of phase IB/II taking into account the target market.

Exit details

Investment conditions

Pre-money value: 5.000.000 euros, to all investors – from risk capital until small investors.

Investment method: Increase in capital shares, formalized at the entrance of the external capital.

Investment modality: Investors will compromise to subscribe among them an agreement on vote syndication, designating a lead investor that will represent all investors in the board meeting.

Estimative profitability: a multiple of 5-6 times the investment in a  4/5 years landscape.

Profitability and return of the investment

Exit strategy is based on:

A) The achievement of a license, co-development agreement or direct sale of the project candidate to a Big Pharma of the oncology sector. The funds will be used to cover the development costs of the drug candidate NAX035, until one of the exit points foreseen. The most common way is through a license agreement that is usually organized in an initial payment (up-front), payments by development milestones and royalties (%) over sales if the product arrives to market.

Following figure shows some common agreements in the oncology area, for products at similar development stage.