CEO’s Corner – June 22, 2013

[Download as PDF ]

Dear Shareholders,

I hope all is well with you and your family and thank you again for your continued support of Iris. This letter is intended to bring you up to speed on our recent activities and the current status of Iris BioTechnologies.

After April of last year, I temporarily suspended routine letters to shareholders. The decision was based on a need for a higher level of security and confidentiality regarding pending legal matters and our future plans.

Our IRB approved breast cancer clinical study was postponed, as we needed to focus our energy and resources on legal matters. Iris hopes to commence a proper clinical study later this year. I would like to take this opportunity to summarize recent events:

  1. 1. Iris decided to file a malpractice claim against the law firm of Heller Ehrman for causing the unintentional abandonment of a key patent.
  2. 2. The question on the patentability of DNA was going through the court process and we wanted to have clarity before launching multiple products.
  3. 3. We have been looking into the enforcement of our patents.
  4. 4. Iris has been exploring and making preparations to expand into the commercial manufacturing phase.

Malpractice Lawsuit Against Heller Ehrman

Since we are currently in legal proceedings regarding this litigation, I am not in a position to elaborate on these matters but rest assured that Iris is working very closely with our attorneys to hold Heller accountable for their malpractices and the damages that they have caused Iris.

Recent Supreme Court Decision

The US Supreme Court made a key decision on DNA patentability on June 13, 2013, and it is great news for Iris. Commenting on the Supreme Court Decision, NIH Director Francis Collins, leader of the Human Genome Project, said: “I am very pleased with today’s ruling by the U.S. Supreme Court in the case of Assoc. for Molecular Pathology Et Al. v. USPTO and Myriad Genetics, Inc. Et Al. that genes isolated from the human body are not patentable. The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care.”

The Supreme Court decision is a blessing for Iris since it has cleared the way for our company to launch planned products without fear of any potential litigation pertaining to gene patents and has opened the door for a great deal of additional revenue by allowing us to offer more products and services that we had not planned on offering due to previous patent constraints. Unlike Myriad Genetics, we have not patented any genes.

Iris’s five issued patents are on our Nano-Biochip™ and BioWindows™ system for analyzing nucleic acids and proteins not only for personalized precision medicine, but also for many other applications. Our patent position is strong, and we are focused on multiple product launches and patent enforcement.

Enforcement of Our Patents

We are doing our due diligence and looking into the enforcement of our patents worldwide. On June 20, 2013, Syntrix, a very small genomic technology company, won a patent infringement lawsuit for $115.1 million dollars for a patent that they filed in 1999. Their website showed that they only have one person on their management team and they have no products.

Expansion Into Manufacturing Phase

In preparation for our growth, we have been looking for an expansion facility in the Bay Area, discussing our future needs with suppliers, and meeting with potential collaborators and service providers both in the U.S. and abroad. Iris has invested more than $9 million in preparation for the launch of multiple products and services and is now prepared to proceed with commercial scale manufacturing. Iris has an extensive pipeline of products and services in many areas, including an initial offering for research and clinical applications in oncology (breast cancer), metabolic diseases (diabetes), neurological disorders (Alzheimer’s and Parkinson’s), and prenatal and pre-conception analysis.

As we grow, we will also be adding new board members, employees, and consultants who are well suited for this next phase. We expect to grow at a rapid pace with product launches, patent enforcement and a potential NASDAQ stock offering. If you have any questions and/or would like to help expedite this phase of Iris’s growth, feel free to contact me at (408-806-7149).

We look forward to our exciting future ahead and thank all of you for your continued belief in Iris.

All the best, Simon Chin
President and CEO

5201 Great America Pkwy, Ste. 320,
Santa Clara, CA 95054
Phone: (408) 867-2885
Fax: (408) 519-3478
Web: www.irisbiotech.com