CytomX Therapeutics Added to NASDAQ Biotechnology Index

SOUTH SAN FRANCISCO, Calif., Dec. 18, 2017 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today announced that the company has been added to the NASDAQ Biotechnology Index (NASDAQ:NBI) effective December 18th, 2017. The index tracks the performance of a set of securities listed on The NASDAQ Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark and that also meet other eligibility criteria. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology.

About CytomX Therapeutics
CytomX Therapeutics is a clinical-stage biopharmaceutical company with a deep and differentiated oncology pipeline of investigational Probody™ therapeutics. Probody therapeutics are designed to exploit unique conditions of the tumor microenvironment to more effectively localize antibody binding and activity while limiting activity in healthy tissues. The Company’s pipeline includes cancer immunotherapies against clinically-validated targets, such as PD-L1 and CTLA-4, and first-in-class Probody drug conjugates against highly attractive targets, such as CD166 and CD71, which are considered to be inaccessible to conventional antibody drug conjugates due to their presence on healthy tissue. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie, Amgen, Bristol-Myers Squibb Company, Pfizer Inc., MD Anderson Cancer Center and ImmunoGen, Inc.  For more information, visit www.cytomx.com or follow us on Twitter.

CytomX Therapeutics
Media:
Spectrum 
Christine Quern
cquern@spectrumscience.com 
202-587-2588

Investors:
Trout Group
Pete Rahmer
prahmer@troutgroup.com 
646-378-2973

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EyeGate Achieves 75% Enrollment in Pivotal Phase 3 Clinical Trial for Anterior Uveitis Triggering Milestone Payment

WALTHAM, Mass., Dec. 18, 2017 (GLOBE NEWSWIRE) — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage, specialty pharmaceutical company with two platform technologies for treating diseases and disorders of the eye, reported that the Phase 3 pivotal trial of EGP-437 for treatment of non-infectious anterior uveitis has reached 75% patient enrollment. Topline data is expected to be released in the second quarter of 2018.

“This is a critical step toward EyeGate’s goal of commercializing an alternative treatment option for anterior uveitis, a condition characterized by inflammation of the anterior chamber of the eye,” commented Barbara Wirostko, M.D., Chief Medical Officer of EyeGate. “We have made tremendous progress with this study and believe we remain on-track to report topline data from this trial in the second quarter of 2018, with an expected NDA filing for EGP-437 in anterior uveitis next year.”

The Phase 3 trial is a double-masked, randomized, positive-controlled trial enrolling 250 subjects in the U.S. It is designed to assess the safety and efficacy of iontophoretically-delivered EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution, through the company’s unique EyeGate® II Delivery System, in patients with non-infectious anterior segment uveitis. The value of the EyeGate® II Delivery System, is the ability to potentially eliminate the need for frequently administered topical steroids over multiple weeks. The primary efficacy endpoint is the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14.

By achieving 75% enrollment in the study, EyeGate has earned a milestone payment under its licensing agreement with a subsidiary of Valeant Pharmaceuticals International (NYSE:VRX and TSX:VRX). In 2015, Eyegate and Valeant entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant exclusive, worldwide commercial and manufacturing rights to its EyeGate® II Delivery System and EGP-437 combination product in the field of uveitis, as well as a right of last negotiation to license such product for other indications. Valeant also has exclusive, worldwide rights to commercial and manufacture this combination product for the treatment of post-operative ocular inflammation and pain in ocular surgery patients, pursuant to a license agreement executed in February 2017.

About EyeGate

EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye.

EyeGate’s CMHA-S platform is based on cross-linking thiolated carboxymethyl hyaluronic acid, a modified form of the natural polymer hyaluronic acid (“HA”). This is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.

EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate, that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System.  www.EyeGatePharma.com.

EyeGate Social Media

EyeGate uses its website (www.EyeGatePharma.com), Facebook page, corporate Twitter account, and LinkedIn page as channels of distribution of information about EyeGate and its product candidates. Such information may be deemed material information, and EyeGate may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor EyeGate’s website and its social media accounts in addition to following its press releases, SEC filings, public conference calls, and webcasts.  The social media channels that EyeGate intends to use as a means of disclosing the information described above may be updated from time to time as listed on EyeGate’s investor relations website.

Forward-looking Statements

Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade Therapeutics, Inc., a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in EyeGate’s other public filings. EyeGate’s results may also be affected by factors of which EyeGate is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Contact:
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com

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Innovation Pharmaceuticals Brilacidin Oral Mucositis Program Moving Forward Based Upon Positive Anchoring Phase 2 Results and Increased Brilacidin Franchise Value

BEVERLY, Mass., Dec. 18, 2017 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today is pleased to provide an update on the developmental plan for Brilacidin, its first-in-class defensin-mimetic drug candidate, for the prevention and treatment of Oral Mucositis (OM).  On December 11, 2017, the Company released topline data from a Phase 2 trial. The study met its primary endpoint of reducing the incidence of severe OM experienced by patients receiving chemoradiation for treatment of Head and Neck Cancer (HNC).

Oral Mucositis is a disease which is largely unfamiliar to the general public, many of whom haven’t witnessed the harsh side effects of OM first hand— namely extreme difficulty swallowing and painful sores in the mouth that can be so intense that cancer treatment must be stopped and a feeding tube inserted.  There are currently no approved drugs for the prevention of severe OM in patients receiving chemoradiation treatment of HNC.  Moreover, OM is a consequence of therapy for an array of cancers, not just HNC, where the incidence rate is particularly high. 

Significant value inflection point for shareholders

Innovation Pharmaceuticals’ Brilacidin is now anchored in OM, representing a value inflection point for shareholders, as further supported by its lead positioning in an untapped $1 Billion market. “Anchored” is an industry term indicating a drug has delivered a meaningful response in a clinical setting for a specific disease along with good apparent safety and toleration. As such, Brilacidin-OM now represents a significant asset to the company.  The next steps will be aimed at defining the most appropriate development plan to complete its evaluation prior to submission for marketing approval. This will involve consultation with the FDA and other health authorities worldwide, once full efficacy and safety endpoint data are available from the recent clinical trial.

Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway.

As there are currently no approved drugs for prevention of severe OM in patients receiving chemoradiation treatment of HNC, management opinion is that Brilacidin-OM has the potential to rapidly assume a lead position after market introduction. This perspective is shared by multiple Pharma companies, potential partners the Company currently is in active discussions with, equally interested in the continued development and eventual market introduction of Brilacidin-OM worldwide.

“I am extremely proud that our team has achieved this very important milestone in cancer care and I feel very optimistic for the future.  There is an urgent need for a drug such as Brilacidin to help cancer patients facing the threat of OM. We will be pursuing every option available to us toward providing these patients with a new therapeutic option,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “I have spoken with family members of patients dealing with OM and to hear the pain and suffering is simply heart-wrenching.  I envision a day where doctors will have a viable option for preventing and treating severe OM and if Brilacidin-OM could be that drug, it would be a considerable accomplishment for the Company, our shareholders and the entire oncology industry.”

About Brilacidin

Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.

Learn more here:
http://www.ipharminc.com/brilacidin-1/

About Brilacidin-OM

Innovation Pharmaceutical’s first-in-class immunomodulatory drug candidate, Brilacidin, targets the prevention of severe Oral Mucositis (OM)—a common and debilitating side-effect of receiving chemoradiation therapy—in Head and Neck Cancer. Each year, OM affects hundreds of thousands of patients worldwide. Only a limited number of OM treatments are available, most of which are palliative in nature. A Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335) has been recently completed in which topline results demonstrate a reduced rate of severe OM (WHO Grade >3) in patients treated with Brilacidin-OM compared to those on placebo.

About Oral Mucositis

Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation. Head and Neck Cancer (HNC) patients—comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN)—are at the greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.

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About the Company
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI), formerly Cellceutix Corporation, is publicly-traded under the company symbol “IPIX”. The Company is clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and the Company more recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo. The Company has recently completed a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer; topline results demonstrate a reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. The Phase 2b data showed a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Results are now available for the completed Phase 2, open label Proof-of-Concept trial, treating patients with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Company website at www.IPharmInc.com.

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals
Leo Ehrlich
info@IPharmInc.com