Investment Project for Enhancing Fertility with Proteins

Our venture is in the process of identifying candidate proteins, peptides, chemicals and running in-vitro and in-vivo models within months.

Enhancing Fertility with Proteins:
“Crossing the barrier for more efficient reproduction and increased Take-Home Baby Rate”
Aim: “Creating Life”
Vision: “The Company will strive to be a Key Player in reproduction healthcare, to enhance fertility and increase reproduction.”
Abstract: “A Novel Formulation for Fertility Enhancement and Increasing Take-Home Baby Rate.”

Our venture bases its innovative technology on evolutionary, chemical and biological properties of the fertility process and by enhancing both male and female potency through a non-invasive technology for enhancing sperm properties and potential for fertilization using addition of formulated proteins. The unique formulation and technology will reduce the need for invasive and hormonal based treatments such as IVF, with a natural, easy to use and risk free process that will increase the chances of conception for couples with fertility impairment, either by enhancing efficiency of artificial insemination or through increasing conception chances for natural intercourse.

The novel technology will also help with family planning for normal couples as well. The company will use proprietary methods to increase the chances of conceiving through natural means and artificial insemination both for normal and infertile couples.

The company sees the market of fertility impaired couples as a major unmet need as well as a field where innovation and originality might discover niches presently neglected by the biotech/pharmaceutical industry.

Our solutions:
• An advanced repositioned NCE (FP-1RB1) scientifically proven to improve sperm motility and endurance in-vitro. A novel vaginal gel formulation in development.
• A protein formulation additive to enhance IUI sperm selection process and potential.
• A Protein formulation for vaginal, Pre-intercourse for enhancing fertilization rate.
• A topical, intra-uterine administration of selected implantation related
proteins, either following standard fertilization, IUI or IVF.

Business opportunity/Market size: The market size is estimated at ~4M patients in the USA alone. With rest of world (ROW), mostly Europe, the number can be doubled (~7-8M patients). Overall estimated at $50B/year.
Competition: There is virtually NO KNOWN competition for topical treatment for direct sperm motility/migration enhancement and fertilization rates before/during intercourse. Moreover, the treatment in IUI is fairly orthodox and does not contain new methods such as sperm enhancement.

Fertility expert, Dr. Arik Kahane, said that: “There is nothing like it, and if there was, Fertility specialists would GLADLY suggest this to patients either before going into any conventional treatment, or alongside with advanced treatment, be it any state of any art...”

Infertility:

Generally, worldwide it is estimated that one in seven couples have problems conceiving, with the incidence similar in most countries independent of the level of the country's development. Fertility problems affect one in seven couples in the UK. Most couples (about 84 out of every 100) who have regular sexual intercourse (that is, every 2 to 3 days) and who do not use contraception will get pregnant within a year. About 92 out of 100 couples who are trying to get pregnant do so within 2 years (for women younger than 35). In people going forward for IVF, roughly half of fertility problems with a diagnosed cause are due to problems with the man, and about half due to problems with the woman. However, about one in three cases of infertility have no clear diagnosed cause.

However, for normal couples, the chance of conception on a given cycle is between 15-30%.

Treatment Status:

Treatment methods for infertility may be grouped as medical or complementary and alternative treatments. Some methods may be used in concert with other methods. There are traditional methods and medical methods both for home uses (such as ovulation tests) and for clinical use at fertility clinics.

Most state of the art treatments for impaired fertility include hormonal treatment combined of followed by invasive procedures such as IVF.

Psychological and Social impact:

In many cultures, inability to conceive bears a stigma. In closed social groups, a degree of rejection (or a sense of being rejected by the couple) may cause considerable anxiety and disappointment. Some respond by actively avoiding the issue; middle-class men are the most likely to respond in this way. There are legal ramifications as well. Infertility has begun to gain more exposure to legal domains. An estimated 4 million workers in the U.S. used the Family and Medical Leave Act (FMLA) in 2004 to care for a child, parent or spouse, or because of their own personal illness. Many treatments for infertility, including diagnostic tests, surgery and therapy for depression, can qualify one for FMLA leave.

Our Solutions:

Our solution to the problems described above will be based on our scientific observations.

There are two steps in development of our solution:
– Increase of Take-Home Baby Rate through enhancement of Intrauterine Insemination (IUI) efficient and success rate
– Increase of Take-Home Baby Rate through a topical intervention in the fertilization process before and during intercourse.

Ways to achieve this:

• An advanced repositioned NCE (FP-1RB1) scientifically proven to improve sperm motility and endurance in-vitro. A novel vaginal gel formulation in development.
• A protein formulation additive to enhance IUI sperm selection process and potential.
• A Protein formulation for vaginal, Pre-intercourse for enhancing fertilization rate.
• A topical, intra-uterine administration of selected implantation related proteins, either following standard fertilization, IUI or IVF.

The company is in the process of identifying candidate proteins, peptides and chemicals, which projected deployment is planned at a Proof of Concept (POC) site and running in-vitro and in-vivo models within months. Using a minimal team, the product will show POC within 18 - 24 months.

To date, there were no significant development costs; however, we’d like to move faster with a selected team of 2-3 employees within the upcoming year.

In order to get minimal POC (within six months), we would like to run a pilot test on two candidates (and their controls), in order to show the effect the proteins have on sperm function in-vitro. For that purpose we are looking for a quick investment of ~$400K, and are willing to allocate equities for that investment, as well as the right for first options/refusal on the full scale investment should basic POC be reached.

In parallel, we are in the process of raising ~$800-1000K, and is willing to allocate company equity towards this purpose. During 2011-2013, the capital will be spent mostly on Research and Development and ensuring milestone progress achievements according to the plan. This in return will enable the company to reach POC and achieve a significant IP portfolio, introducing the technology to the Pharma and fertility market. An additional capital fundraising round (in the order of $3-5M) is anticipated during the beginning or second half of 2013 in order to begin substantial preclinical and FIH development process.

In a market of ~$50B/year, a company such as ours, as a single player in the field of non-IVF related fertility, is worth a second look. With high slice of equities with any small investment, the idea is to take advantage of the early stage of the company, and even thought the risk is high, the cost is not too much so...