IPO Report: EyeGate Pharmaceuticals (EYEG)

Francis Gaskins  |

EyeGate Pharmaceuticals ($EYEG) EYEG is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. It is based in Waltham, MA.

Ten other companies are scheduled for the week of Sept. 29, 2014. The full IPO calendar is available at IPOpremium.

Manager, Co-managers: Aegis Capital

End of lockup (180 days): Wednesday, April 1, 2015

End of 25-day quiet period: Tuesday, October 28, 2014

EYEG scheduled a $25 million IPO on Nasdaq with a market capitalization of $92 million at a price range midpoint of $13 for Friday, October 3, 2014 on Nasdaq. SEC filings

EyeGate Pharmaceuticals IPO Report


EYEG is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye.



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% offered in IPO

Annualizing June 6 mos


Eyegate Pharmaceuticals (EYEG)










High cash burn rate:  P/E ratio of -7.6

No collaborations

1st pivotal Phase 3 trial completed

Shareholders indicated an interest in purchasing $2.5 million of the IPO.


EYEG is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye.

EGP-437, EYEG’s first and only product in clinical trials, incorporates a reformulated topically active corticosteroid, dexamethasone phosphate, that is delivered into the ocular tissues through its proprietary innovative drug delivery system, the EyeGate® II Delivery System.

FDA pathway

EGP-437 is being developed under the 505(b)(2) New Drug Application, or NDA, regulatory pathway for drugs submitted for approval to the U.S. Food and Drug Administration, or FDA, which enables an applicant to rely, in part, on the FDA’s findings of safety and efficacy for an existing product, or published literature, in support of its NDA.

An example of an existing product on which EYEG believes that it can rely, in part, for a 505(b)(2) NDA filing is Decadron®, a topical dexamethasone formulation. EYEG selected prednisolone acetate ophthalmic suspension (1%), or PA, due to a communication received from the FDA, dated December 3, 2007, which stated that the FDA recommends that prednisolone acetate ophthalmic suspension 1%, or PA, administered at least four times per day, be the positive control agent for the treatment of anterior uveitis.

IND submitted in 2008

An Investigational New Drug application, or IND (IND 77,888), for EGP-437 was submitted to the FDA on April 28, 2008, which was subsequently amended.

Addresses two major issues

The EyeGate® II Delivery System and EGP-437, are designed to address two major issues in ophthalmic medicine: lack of patient compliance and safety.

The EyeGate® II Delivery System features a compact, elegant, and easy-to-use device that EYEG believes has the potential to deliver drugs non-invasively and quickly into the ocular tissues through the use of iontophoresis, which can accelerate the onset of action, dramatically reduce treatment frequency versus eye drops and sustain therapeutic effect. Iontophoresis employs the use of a low electrical current that promotes the migration of a charged drug substance across biological membranes.

The current produces ions, which through electrorepulsion, drive a like-charged drug substance into the tissues.

The EyeGate® II Delivery System is easy-to-use, only takes a few minutes to employ and has been utilized to administer more than 1,700 experimental treatments. EYEG holds worldwide commercialization rights to the EyeGate® II Delivery System.

Initially, EYEG is developing EGP-437 for the treatment of non-infectious anterior uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body. EYEG intends to expand the use of EGP-437 to other inflammatory ocular indications such as, dry eye, where a deficiency in either the volume or composition of the tear film can produce an immune-based inflammation of the ocular surface, macular edema, an abnormal thickening of the macula associated with the accumulation of excess fluids in the extracellular space of the neurosensory retina, and seasonal allergic conjunctivitis, which involves an acute or subacute condition characterized by self-limited signs and symptoms that become persistent with repeated allergen exposure during pollen season.

The hallmark signs and symptoms of seasonal allergic conjunctivitis are itching, redness and lid swelling along with tearing, mucous discharge and burning.

Initial Phase 3 clinical trial completed

EYEG’s first pivotal Phase 3 clinical trial relating to the treatment of non-infectious anterior uveitis has been completed, and EYEG anticipates that an additional or confirmatory Phase 3 trial will be sufficient to support the FDA registration of the combined EGP-437 and the EyeGate® II Delivery System, or the EGP-437 Combination Product.

EYEG anticipates initiating this confirmatory Phase 3 trial in the second half of 2014 and completing it in the first half of 2016.

Subject to regulatory approval, EYEG hopes for a U.S. commercial launch of the EGP-437 Combination Product for non-infectious anterior uveitis in 2017. In comparison to existing treatments for non-infectious anterior uveitis, EYEG believes that patients may benefit from the potential elimination of demanding dosing schedules, rapid relief of symptoms, increased comfort and reduced side effects.

Physician benefits may include increased control of patient compliance, rapid onset of action, and increased office efficiency.

The EyeGate® II Delivery System has the potential to offer a non-invasive method of drug delivery as an alternative to the current delivery modalities used for treating ocular diseases, such as eye drops and ocular injections.

In-office preparation is simple and efficient and can be completed by nursing or other office staff. Utilizing the EyeGate® II Delivery System, EYEG has demonstrated in vivo (preclinical) the ability to deliver a wide range of molecules from small molecules to biologics (such as antibodies) to the front and back of the eye.

Intellectual property

EYEG’s patent portfolio includes drug delivery device patents directed to the EyeGate® II Delivery System and other drug delivery devices, drug composition patent applications directed to EGP-437 and other product candidates, and patent applications directed to methods of treatment utilizing EGP-437, as well as the other product candidates.

These patents and patent applications, if they were to issue, are expected to expire between 2018 and 2029.


EYEG’s potential competitors include large pharmaceutical and biotechnology companies, and specialty pharmaceutical and generic drug companies.

Many of EYEG’s competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than EYEG does.

These competitors also compete with EYEG in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, EYEG’s programs.

Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

The key competitive factors affecting the success of each of EYEG’s product candidates, if approved for marketing, are likely to be its efficacy, safety, method of administration, convenience, price, the level of generic competition and the availability of coverage and adequate reimbursement from government and other third-party payors.

EYEG’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that EYEG may develop.

EYEG’s competitors also may obtain FDA or other regulatory approval for their products more rapidly than EYEG may obtain approval for EYEG's, which could result in EYEG’s competitors’ establishing a strong market position before EYEG is able to enter the market.

In addition, EYEG’s ability to compete may be affected in many cases by insurers or other third party payors seeking to encourage the use of generic products.

Generic products currently being used for the indications that EYEG may pursue, and additional products are expected to become available on a generic basis over the coming years. If its product candidates achieve marketing approval, EYEG expects that they will be priced at a significant premium over competitive generic products.

EYEG’s competitors in the treatment of non-infectious anterior uveitis include Durezol® (Novartis AG), Lotemax® (Valeant Pharmaceuticals International, Inc.), Pred Forte® (Allergan, Inc.) and prednisolone acetate ophthalmic suspension (1%) (Novartis AG).

5% shareholders pre-IPO

Entities affiliated with Ventech SA           44.7%

Entities affiliated with IPSA          20.0%

Natixis Private Equity     12.1%

Stephen From   5.7%

Thomas Balland  20.0%

Dividend Policy

No dividends are planned.

Use of proceeds

EYEG intends to use the $20 million in proceeds from its IPO as follows:

$8 million to fund, through completion, its confirmatory Phase 3 clinical trial for the treatment of non-infectious anterior uveitis with the EGP-437 Combination Product;

$2 million to fund, through completion, its endothelial cell count safety trial with the EGP-437 Combination Product;

$1.3 million to fund, through completion, two proof-of concept trials using the EGP-437 Combination Product;

$2 million to advance a second molecule through formulation, preclinical and IND enabling studies; and

the remainder for working capital and other general corporate purposes, which will include the pursuit of its other research and discovery efforts and could also include the acquisition or in-license of other products, product candidates or technologies.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer


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