2a ronda: CEBIOTEX

MainImage

299,032.82€

Out of 300,000.00€

investors

67

Est. ROI

700%

days left

--

After the outstanding success of its first crowdfunding campaign, CEBIOTEX extends its round with a second offer at Capital Cell.

Finish date: 31/05/2016 Barcelona

Premoney valuation

2,500,000.00€

Percentage offered

10.71%

Est. ROI

700%

Exit horizon

2021

The project

When an oncological surgeon removes a cancer tumor, there is a medical need to ensure the surgical site is free of cancer cells. During 3-4 weeks after the procedure no radiotherapy or chemotherapy treatments can be applied in order to enable scarring of the wound. This 3-4 weeks are crucial because, if cancer cells are left, these can reproduce quickly without any treatment, growing the tumor back, which may later be hard to contain with radio or chemotherapy. 

 

37% of all breast cancers removed eventually regrow; in the case of Glioblastoma, the regrowth rate after surgical removal is almost 100%, with a life expectancy under 14 months.

 

Cebiotex is developing local control solutions for post-surgical oncology, such as the CEB-01, a membrane containing antitumor drugs with which the area surrounding the extracted tumor (the surgical site) can be wrapped. Cebiotex' membrane is inert, nontoxic, is easily reabsored and can be used with the most effective drug for each tumor type

 

This membrane greatly limits the viability of cancer cells remaining after the surgical procedure. When applying this membrane directly on the tissues, its efficacy is very high without the need to remove large amounts of tissue during the intervention. 

 

In particular, CEB-01's system is designed for soft tissue sarcoma and is formed by a 3D structure of biocompatible and biodegradable nanofibers (PLGA) containing cytostatic SN-38. The membrane, after releasing the cytostatic locally for weeks, is biodegraded and disappears. It has shown a very promising efficacy and toxicology in in-vivo experiments. 

Left: tumor reproduction in mice after removal of Ewing's sarcoma and implantation of Cebiotex' CEB-01 membrane: NO TUMOR CELL VIABILITY. 

Right: tumor reproduction in mice after removal of Ewing's sarcoma without implantation of Cebiotex' CEB-01 membrane. TUMOR REPRODUCTION.

 

Pediatric Oncology

Cebiotex is, first and foremost, a project born to provide a medical solution to childhood cancers. Their low frequency makes them a low priority area for the medical industry, even if the disease has a devastating effect in the families suffering it. 

 

30.000 new cases of childhood cancer are diagnosed every year in Europe and the USA, with a mortality of approximately 20%. In spite of that, during the last 20 years only 3 treatments for pediatric cancer have been developed.

 

Cebiotex was born when Sara, a 6-year old girl, passed away after fighting against a pediatric cancer for 4 years. Resulting from the feeling of powerlesness during the disease, J.B, co-founder and textile engineer, decided to create new bio-materials that could provide medical solutions in both pediatric and adult oncology. The outcome is a project with a great potential and financial viability in cancer treatment at any age. 

The team at Cebiotex is determined to seize this financial oportunity in the market for adult oncology to develop treatments for pediatric oncology.

Business opportunity

The first candidate coming out of CEBIOTEX®'s technological platform, CEB-01, is aimed at those tumors in which local control after oncological surgery is necessary to improve prognosis. Inside these tumor type, SN-38 is used in the following tumors: 

- Colono rectal cancer - Breast cancer
- Ovary cancer - Head and neck cancer 
- Lung cancer - Adult soft tissue sarcoma (STS).
- Pancreatic cancer 
- CNS glioma (“brain cancer”)
- Pediatric cancer (neuroblastoma / soft tissue sarcoma (STS))

 

CEB-01's first therapeutical application will be adult soft tissue sarcoma (STS); with 40.000 new cases/year (13.000 deaths/year) in the USA and the EU and a potential market of 256 million euros

The "DNA" at Cebiotex is to work in the field of pediatric oncology, and therefore we will continue with the development of our product for pediatric STS. 

 

Products in the market

A comparable solution already in the market would be Gliadel, Polifeprosan 20 wafers for post-surgical control of glioma (brain tumors), with estimated sales of $110 million in 2013, in a $1400M global market. It is currently sold in Spain for a price of €8.365 per intervention. 

Cebiotex' technology will offer a product with less secondary effects and higher efficacy, for a similar (or lower) price. 

 

CEBIOTEX® competitive advantages

1 - CEBIOTEX® can administrate active ingredients (cytostatics, bios,...) in high local doses with optimal release: 

  • very promising efficacy 
  • very low local and systemic 

2 - CEBIOTEX® perfectly adapts to the treatment area and can be easily handled by the surgeon 

3 - CEB-01 is a universal product. Any surgeon can use CEB-01 after surgery, withouth any special equipment or operating room. Unlike radiotherapy, which requires very costly equipment, unaffordable for many hospitals.

Investment & Exit

Total investment for this round is 1'8 million euros, which will get the company through Regulatory Pre-clinical development. 

* What is Regulatory Pre-Clinical development?
When a drug has obtained good results after being tested on animals, health autorities demand that an officially homologated organism reproduces these results before allowing any trial in humans. This is the last step before clinical trials with real patients


1.- The identified financial need, which will get the company through Preclinical Phase and develop an organisational structure according to these goals is 1,8 million euros. Preclinical Phase is expected to be finished by september 2017. 


2.- The financial need will be covered through a capital increase of 1,0 million euros and leveraging with 0,8 million euros of public funding (Cebiotex just received NEOTEC funding for 175.000 euros).  


3.- Funding for the first part (bridge funding): 300.000€ through convertible note using the valuation for the second part with a 20% discount, and 6% interest. Minimum investment 1000€. 

-> This round was closed on the 15th of April, 2016.

After the success of its first crowdfunding campaing, CEBIOTEX has decided to launch a second one: 300.000€ through convertible note using the valuation for the second part with a 20% discount, and 6% interest. Minimum investment 1000€. 

-> This is the round currently open at Capital Cell


4.- Funding for the Second Part (valuation): 400.000€ through capital increase and loan capitalization (last negotiation phase with Venture Capital). 


5.- Estimated Calendar: First part: april 2016 (funding) may 2016 (signature); Second part: september 2016 


6.- Trading partners agreement: tag along/drag along/information, etc.

 

Investment conditions

PRE-MONEY VALUATION: 2.500.000€, for every investor - from Venture Capital to small investors. 
INVESTMENT METHOD: Convertible equity note, which will be converted on december the 31st, 2016, or whenever the deal with a Venture Capital is closed, with a 20% discount on the valuation. 

Video: What's a convertible note? (In Spanish only)


INVESTMENT MANAGEMENT: through CEBFUNDING S.L., a special purpose vehicle already aggregating 58 investors. 

ESTIMATED ROI: 700% in 5/6 years

EXIT STRATEGY: CEBIOTEX' business model is based on developing products until a sublicensing or sale DEAL is reached with a Multinational Company. In the Pharma sector it is usual to reach the deal once products are in Phase I/II of the clinical development (they have been tested in humans), and are then developed by the Pharma Company until Phase III and market launch. Therefore, CEBIOTEX has planned two possible exit strategies: 

a) through SUBLICENSING:

  1. First candidate “CEB-01”.
  2. CEBIOTEX® platform, applied to oncology for ADULTS / CHILDREN.
  3. CEBIOTEX® platform, applied to different medical conditions. 

b) through SALE, total or partial, of the Company.
 

As reference exits, similar products have been acquired by big companies in 2014:

  • Merrimack Pharmaceuticals (product: MM398 nanoliposomal irinotecan for pancreatic cancer); acquired by Baxter for a initial payment of $100 M, total potential of $970M 
  • Opko Health (product: Long acting hGH-CTP for growth hormone deficiency (GHD) in adults and children); acquired by Pfizer for an initial payment of $295M, total potential of $570M 

If you want to know more you can contact the team at Cebiotex (http://www.cebiotex.com/es/contactus/) or Capital Cell (info@capitalcell.net).

Drivers

CEBIOTEX S.L. spun off the Hospital Sant Joan de Déu de Barcelona (HSJD) and the Universidad Politécnica de Catalunya (UPC). Created on 2012 and based in the Parc Científic de Barcelona, Cebiotex is an innovative, technology-based SME.

 

Joan Bertran. 

Technical industrial engineer by the UPC. Entrepreneur, co-founder and CEO. Full-time dedication since Oct-2013. Master in Operations Management (EADA); MBA (ICT). >20 years of experience in executive positions in industrial companies as COO. 

 


 

José Antonio Tornero 

Industrial Engineer by UPC. Co-founder and CTO. Head of the Systems and processes lab at INTEXTER Terrassa (UPC). Expert with international recognition in electrospinning technology (nanofibers) and management of technology-based projects. 

 

 


 

Lucas Krauel PhD. 

Graduate in medicine and surgery by UB. Co-founder and CSO.
Pediatric surgeon specialised in pediatric oncological surgery,
 Hospital Sant Joan de Déu. 
Fellow Pediatric Surgical Oncology. Memorial Sloan Kettering CancerCenter, New York, USA.

 

 


 

Jaume Mora MD. PhD. 

PhD in Medicine. Co-founder and Chairman Scientific Advisory Committee.
Scientific director, area of Onco-Hematology, Hospital Sant Joan de Déu de Barcelona.
Alumni Pediatric Hematology and Oncology; Molecular Pathology. Memorial Sloan Kettering Cancer Center, New York.

 

 


 

Xavier Luria PhD. 

Graduate in Medicine and Surgery by UB. Cebiotex Drug Development Regulatory Affairs Advisor.
Senior consultant DDR Barcelona-London. He has been exposed to this area from a triangle perspective: as a hospital’s medical doctor with postgraduate training in internal medicine, as clinical researcher and management and leadership positions in pharma industry and, finally, as relevant European Medicines Agency (EMA) manager.

 


 

Javier Merino PhD. 

Institut Superieur de Gestion, Paris. Cebiotex Legal Advisor.
Founder and Managing Partner of Innovatech Law Firm. Previously, Baker&McKenzie; Clifford Cance LLP; Osborne Clarke.
He has lectured on issues related to the Protection of Industrial and Intellectual Property, Technology transfer and Licensing, Personal Data, ....

 

 


 

Marc Ramis PhD. 

Biochemistry, University of Oxford, PLD Executive, Harvard Business School. Cebiotex Business Development Advisor.
Marc is an entrepreneurial business developer focused on science commercialization and innovation management .
He has a significant track record translating science to the market, developing R&D strategies to innovative business models, leading new ventures, approaching investors and negotiating with clients from both public and private sectors.

 


Jordi Petit Salamó. 

BBA and MBA, Esade (Barcelona). CEMS master, HEC (París). Cebiotex Financial Advisor.
Partner at Vantum Corporate; highly experienced in Corporate Finance, Venture Capital and finance in start-ups, SMEs and multinational companies. He was co-founding partner at BPMO edigrup, CFO at Betne, financial analyst at Bull Europe (París), Corporate finance consultant at KPMG, Management Controller at Grupo Nobel, Investment director at Caixa Capital Risc and CFO at Oryzon Genomics.

Product/Service

When the oncological surgeon removes a cancer tumor, there is a MEDICAL NEED to ensure the sugical site is free of cancer cells. 

“CEB-01” has been developed to SOLVE such medical need, with local control of post-surgical oncology. It greatly reduces the viability of the cancer cells remaining after the surgical intervention.

“CEB-01” is formed by a 3D structure of biocompatible and biodegradable nanofibers (PLGA), loaded with the cytostatic (SN-38). The membrane, after releasing the cytostatic locally for weeks, is degraded and disappears. 

CEBIOTEX' proposal for the first clinical trial in humans has been supported by the EMA, the european medicines agency. 

With its second funding round, CEBIOTEX plans to continue its dialogue with the EMA during the preclinical and clinical development of "CEB-01" through: 

  1. Addional monitoring of the Scientific Advice. 
  2. Protocol Assistance.
  3. “Orphan” designation for the soft tissue sarcome, which greatly eases the regulatory procedure
  4. Consulting national regulatory organisms about the corresponding clinical trials. 

Intellectual property

CEBIOTEX has generated 7 patents, of which 4 are still ongoing, with one of them granted. The freedom to operate analysis for "CEB-01" has been positive, which means the product can be commercialised without interfering with any existing patent:  

  1. European Priority Patent nº12162338.3, (30-03-12); granted.
  2. Patent PCT/EP2013/056522, (27-03-13). It has generated:
  • US_14/389,330, (29-09-14); USA, being processed.
  • 201380027164.7, (15-12-14); China, being processed.

      3. Spanish patent P201431189, (04-08-14); abandoned for the PCT:

  • PCT/EP2015/067763, (03-08-15); being processed.

The patents are property of the Hospital Sant Joan de Déu de Barcelona, and the Universidad Politécnica de Catalunya. They've been exclusively licensed to CEBIOTEX, S.L., with a contract adapted to the entrance of private capital and Venture Capital firms. 

Market

The company's reference markets and principal applications for its first candidate CEB-01 are:

  • Soft tissue sarcome (STS). It is estimated that there are 40.000 new cases and 13.000 deaths each year caused by STS in the USA and the EU alone.Its application in colono-rectal cancer and CNS glioma will be developed thereafter.  
  • We are focusing on the USA, EU, China, Japan and Korea. 

As an example of the market volume we are targeting, "Gliadel" (post-surgery local control of brain tumors, Glioma) is currently available in Spain for a price of 8.365 €/ intervention. There were 57.100 cases of brain nervous system cancer in the United States in 2012, which equals to: 

57.100 cases x 8.365€ = 477.641.500€ potential market for GLIADEL in the EU.

Marketing & sales

The company's strategy is based on generating awareness in:

a)    The scientific world (investing in science, publishing and with a potent SAB). 
b)    Medical, hospital and patient organisations. 
c)    Large investment funds in Venture Capital and Impact investment. 
d)    ASCO, BIO, SIOP, APSA, BIO-EUROPA during 2016.


When it comes to sales, CEBIOTEX' business model is plans to sublicense or sell the company to Pharmaceutical companies interested in the product. 

Roadmap

CEBIOTEX' roadmap is focused on following the regulatory pathways of the regulatory agencios in the USA and the EU (FDA and EMA). Its pipeline currently has three products: 

CEBIOTEX, due to its "Pediatrical DNA", is strongly committed to develop its ADULT products for PEDIATRICAL indications. 

Forecast

CEBIOTEX has planned exit strategies based on the following similar drug delivery deals:

  • Merrimack Pharmaceuticals / Baxter; MM398 nanoliposomal irinotecan for pancreatic cancer; 970M$ (100M$ upfront).
  • Opko Health / Pfizer; Long-acting hGH-CTP for growth hormone deficiency (GHD) in adults and children (p3); 570M$ (295M$ upfront).
  • Adocial / Eli Lilly; BioChaperone Lispro (ultra-rapit insulin) for 1 and 2 diabetes; 570M$ (50M$ upfront).

Investment details

Total investment for this round is 1'8 million euros, which will get the company through Regulatory Pre-clinical development. 

* What is Regulatory Pre-Clinical development?
When a drug has obtained good results after being tested on animals, health autorities demand that an officially homologated organism reproduces these results before allowing any trial in humans. This is the last step before clinical trials with real patients


1.- The identified financial need, which will get the company through Preclinical Phase and develop an organisational structure according to these goals is 1,8 million euros. Preclinical Phase is expected to be finished by september 2017. 


2.- The financial need will be covered through a capital increase of 1,0 million euros and leveraging with 0,8 million euros of public funding (Cebiotex just received NEOTEC funding for 175.000 euros).  

3.- Funding for the first part (bridge funding): 300.000€ through convertible note using the valuation for the second part with a 20% discount, and 6% interest. Minimum investment 1000€. 

-> This round was closed on the 15th of April, 2016.

After the success of its first crowdfunding campaing, CEBIOTEX has decided to launch a second one: 300.000€ through convertible note using the valuation for the second part with a 20% discount, and 6% interest. Minimum investment 1000€. 

-> This is the round currently open at Capital Cell


4.- Funding for the Second Part (valuation): 400.000€ through capital increase and loan capitalization (last negotiation phase with Venture Capital). 


5.- Estimated Calendar: First part: april 2016 (funding) may 2016 (signature); Second part: september 2016 


6.- Trading partners agreement: tag along/drag along/information, etc.

Exit details

Investment conditions

PRE-MONEY VALUATION: 2.500.000€, for every investor - from Venture Capital to small investors. 
INVESTMENT METHOD: Convertible equity note, which will be converted on december the 31st, 2016, or whenever the deal with a Venture Capital is closed, with a 20% discount on the valuation. 

Video: What's a convertible note? (In Spanish only)


INVESTMENT MANAGEMENT: through CEBFUNDING S.L., a special purpose vehicle already aggregating 58 investors. 

ESTIMATED ROI: 700% in 5/6 years

EXIT STRATEGY: CEBIOTEX' business model is based on developing products until a sublicensing or sale DEAL is reached with a Multinational Company. In the Pharma sector it is usual to reach the deal once products are in Phase I/II of the clinical development (they have been tested in humans), and are then developed by the Pharma Company until Phase III and market launch. Therefore, CEBIOTEX has planned two possible exit strategies: 

a) through SUBLICENSING:

  1. First candidate “CEB-01”.
  2. CEBIOTEX® platform, applied to oncology for ADULTS / CHILDREN.
  3. CEBIOTEX® platform, applied to different medical conditions. 

b) through SALE, total or partial, of the Company.
 

As reference exits, similar products have been acquired by big companies in 2014:

  • Merrimack Pharmaceuticals (product: MM398 nanoliposomal irinotecan for pancreatic cancer); acquired by Baxter for a initial payment of $100 M, total potential of $970M 
  • Opko Health (product: Long acting hGH-CTP for growth hormone deficiency (GHD) in adults and children); acquired by Pfizer for an initial payment of $295M, total potential of $570M 

If you want to know more you can contact the team at Cebiotex (http://www.cebiotex.com/es/contactus/) or Capital Cell (info@capitalcell.net).