Infante Viñolo, Juan José

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Innovating in Biotechnology in charge of the baton: how I should organize my orchestra?CNIC – PhD day 2019Workshop for future entrepreneursDr. Juan José INFANTE VIÑOLO22 NOV 2019THE CEO THE CSO1. THE MONEY2. THE BUSINESS PLAN  - BUSINESS MILESTONES3. THE SCIENCE – TECHNICAL MILESTONES4. ALIGNMENT – CLEAR MODEL OF TECHNOLOGY TRANSFERYou need a CEO (CEO + CFO + COO)FFFF”Founders, Fools, Family, and Friends”100-500KBABusiness Angels100K-1MVCVenture Capital>1MNEW INVESTORSIPO(Stock Market: MaB, Euronext, Nasdaq)SELL!!private moneySOFT LOANSUp-front3 yearsRetos Colaboración – Spain (200K)Enisa-Spain (200K)CDTI –Spain (200K)GRANTS TO THE COMPANYDelayed CASH (1.5 years)Non-refundableERDF funds – Spain (0.5-1.0M)EIC Accelerator (SME Instrument)-EU (>2M)Specialized accelerator programs (>2M)GRANTS TO THE PUBLIC GROUPNeed a good transfer model!public moneyBefore beginning, become an expert in your sources of MONEYno banks availableSTAGE 2: PRECLINICALSTAGE 3: PHASE ISTAGE 4: PHASE 2STAGE 5: PHASE 3MARKET AUTHORIZATIONrisk 23%risk 45%risk 47%71%STAGE 1: PROOF OF CONCEPTWhat is my pathway?I need1MMy value is1MI need4MMy value is10MI need4MMy value is80MI need30MMy value is800MI need300MMy value is2000MSTAGE 2: PRECLINICALSTAGE 3: PHASE ISTAGE 4: PHASE 2STAGE 5: PHASE 3MARKET AUTHORIZATION71%STAGE 1: PROOF OF CONCEPTLicensing contractsI need1MMy value is1MI need4MMy value is10MI need4MMy value is80MI need30MMy value is800MI need300MMy value is2000MLicensingINLicensingOUTrisk 23%risk 45%risk 47%A case of successIt’s all about MONEYIn order to reach my 1st important business milestone, I need to borrow money: when? who? how much? how will I success? The more I increase valuation of the Company with founders’ money, the better If I want to ask for 8M and give 40%, then I have to convince investors that the company’s value is 8M/0,4= 20M If I have access to a grant covering 4M, then the value is 4M/0,4= 10Mwhen? High valuation; when you need it!!who? Specialized investor (understand the business, connection with licensors, good track record)how much? The money that you really need to reach a key business milestonehow will I success? TEAM; BUSINESS PLAN; PAST (results translated into business; KoL’s support); CONFIDENCE; TIME (alignment, the deal breaker)STAGE 2: PRECLINICALSTAGE 3: PHASE ISTAGE 4: PHASE 2STAGE 5: PHASE 3MARKET AUTHORIZATION71%STAGE 1: PROOF OF CONCEPTFounder’s shareI need1MMy value is1MI need4MMy value is10MI need4MMy value is80MI need30MMy value is800MI need300MMy value is2000MLicensingINLicensingOUTrisk 23%risk 45%risk 47%Founder’s share100%Founder’s share75%Founder’s share51%Founder’s share37,09%ScientistsServices/Co-development Agreement with Public Institution (ALIGMENT!!)Scientists/Project ManagersPatent Lawyers (the patents!!)Regulatory PeopleCFO & Financial StaffHow to manage R&D accountabilityThe BoardInvestors/Shareholders (the Agreement!!!)Advisors/LawyersCMOs/CROs/ConsultantsThe Best service providers!OpportunityVaccines to prevent antibiotic-resistant infections70% of R&D expenses covered until key business milestoneDr. Juan José InfanteCEOJuanjo.infante@Vaxdyn.comNovember 2019LISBON INVESTORS CONFERENCEAntibiotic-resistant infections: emergencyVaccines should come first - The review on antimicrobial resistance chaired by Jim O'Neill, May 2016 Post-Antibiotic EraPopulation at risk 2019: 74 millionDeaths in 2018: 700.000Cost associated in 2018: 40 billion $Deaths forecasted for 2050: 10 millones2 Barriers: technology & market introductionWho’s killing us?https://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf?ua=1Phase 1 Phase 2 Phase 3 TotalCandida 0 1 0 1 0 0.3Clostridium difficile 0 1 1 2 0 0.9Escherichia coli 1 1 0 2 0 0.5Gorup B Streptoccocus 1 1 0 2 0 0.5Shigella 0 1 0 1 0 0.6Stapylococcus aureus 1 1 1 3 0 1.1Streptococcus pneumoniae 1 3 0 4 3 1.1Mycobacterium tuberculosis 0 2 0 2 1 0.6Acinetobacter baumannii 0 0 0 0 0 0Pseudomonas aeruginosa 0 0 0 0 0 0Klebsiella pneumoniae 0 0 0 0 0 0Total 4 11 2 17 4 5.6TARGETCLINICAL STAGE PIPELINERegistered Expected NewTable 1. Vaccines against resistant bacteria. Industry pipeline as of Feb 2018Old solution – Modern challenge: VaccinesPriority 1Priority 1Priority 3Priority 2Priority 3TeamDr. Michael J. McConnellBacteriologist, CSOKOL Dr. Jerónimo Pachón25 years director Infection Diseases Unit at Hospital Univ. Virgen del Rocío of SevilleDr. Francisco LeónImmunologist, pharmaceuticla developer, entrepeneurEx-VP Janssen-Johnson & JohnsonCo-founder Celimmune & Provention Bio (NASDAQ)TeamDr. Juan José InfanteCEO12 years private biotechnology vaccines valuationUniv. Washington Hospital (Seattle)Dra. Pilar PérezVirologitsImmunologistNational Microbiology Center of Spain Health Institutes  (ISCIII, Madrid)Insitute of Biomedicine of Seville (IBiS)Biodextris (CMO active ingredients; Montreal)Laboratorios Reig-Jofré (CMO final product; Barcelona)Overcoming the barriers: our pole and our mattress Private international organization with headquarters in the USA Phase I completed in 4 years Technology validation Access to NIH preclinical services; Expert Advisory Board EUR 5.2 MILLION GRANT (70% R&D) Non refundable Non dilutiveTechnology validated; Manufacturing validatedInactivated multi-antigen whole-cell vaccines based on a LPS (endotoxin)-negative strain of Acinetobacter baumanniiOmpANew antigenAcinetoVaxIP-protected in Europe, USA, Japan, China, India, and MéxicoKaPaVax: multivalent vaccineKaPaVax: Multi-Presentation of antigens from Pseudomonas aeruginosa and Klebsiella pneumoniae in the LPS-negative cell of A. baumannii3 Pseudomonasantigens2 Klebsiella antigens KaPaVaxKAPAVAX VACCINEMULTIVALENTthe 3 top priority 1 pathogens, responsible for 50% bacterial infections causing pneumoniaSAFESCALABLE8000 doses/LOvercoming the barriers: looking for the target population36 million people with COPD in EU and USA1/3 (12 million) with advanced airflow obstruction (FEV1<50% expected value)Recruitment of those with severe acute exacerbations requiring mechanical ventilation  for clinical phases II-IIIPrimary Target PopulationFinal message1. Innovative and validated technology for a public health highly unmet need2. Project and Plan validated by an international organization with highly qualifiedexperts in the field in the Advisory Board3. Substantial non-dilutive grant resulting in highly discounted equity4. The sponsorship of this organization and current talks with pharmaceutical companiessupport the potential exit and ROI of investmentTHE CEO THE CSO1. THE MONEY2. THE BUSINESS PLAN  - BUSINESS MILESTONES3. THE SCIENCE – TECHNICAL MILESTONES4. ALIGNMENT – CLEAR MODEL OF TECHNOLOGY TRANSFERAre you willing to take the journey?ScientistsServices/Co-development Agreement with Public Institution (ALIGMENT!!)Scientists/Project ManagersPatent Lawyers (the patents!!)Regulatory PeopleCFO & Financial StaffHow to manage R&DaccountabilityThe BoardInvestors/Shareholders (the Agreement!!!)Advisors/LawyersCMOs/CROs/ConsultantsThe Best service providers!

Innovating in Biotechnology in charge of the baton: how I should organize my orchestra?

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Innovating in Biotechnology in charge of the baton: how I should organize my orchestra?

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