On November 6, 2018 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported operating and financial results for its fiscal 2019 first quarter ended September 30, 2018 and highlighted recent clinical and operational developments (Press release, pSivida, NOV 6, 2018, View Source [SID1234530856]).

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"The approval of YUTIQ by the U.S. FDA in October marked a significant achievement for EyePoint and validates the Company’s innovation and ability to develop an effective treatment to decrease recurrence of uveitic flares from non-infectious posterior segment uveitis that can result in blindness," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "Following the positive reception by retina and uveitis specialists of the clinical data presented for YUTIQ at the American Academy of Ophthalmology 2018 Annual Meeting, we believe that we are well-positioned for a successful product launch planned in the first quarter of calendar 2019. In addition, we are scaling up our manufacturing of DEXYCU ahead of an anticipated launch in the first half of calendar 2019."

Recent Clinical & Operational Highlights

In October 2018, the U.S. Food and Drug Administration (FDA) approved YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, a three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ utilizes the Company’s Durasert drug delivery technology and is an intravitreal micro-insert designed to deliver drug consistently over 36 months. The approval occurred 24 days in advance of the PDUFA date of November 5th.

At the American Academy of Ophthalmology (AAO) 2018 Annual Meeting in Chicago, IL, 24-month efficacy and safety data supporting YUTIQ was presented during the Retina Subspecialty day at a breakthrough presentation entitled, "24-month Evaluation of Fluocinolone Acetonide Intravitreal Insert Treatment for Non-Infectious Posterior Uveitis". These data demonstrated that the recurrence rate in randomized eyes treated with YUTIQ was significantly lower than in sham eyes (59.8% vs. 97.6%, respectively; p<0.001) at 24-months of the three-year trial. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints.

In August, safety and efficacy data from the Phase 3 clinical trial of DEXYCU compared to prednisolone acetate 1.0% ophthalmic drops for the treatment of inflammation post-cataract surgery were published in the Journal of Cataract & Refractive Surgery. Results demonstrated similar efficacy and safety between both products in treating inflammation post cataract surgery with a preference of DEXYCU compared to drops.

EyePoint granted Ocumension Therapeutics, a China-based ophthalmology company, an exclusive license to develop and commercialize EyePoint’s three-year micro insert product using the Durasert technology for chronic, non-infectious uveitis affecting the posterior segment of the eye in the greater China territory, which is comprised of China, Hong Kong, Macau and Taiwan. EyePoint will receive a one-time upfront payment of $1.75 million and is eligible to receive up to an additional $10.0 million if certain future prespecified development, regulatory and commercial sales milestones are achieved by Ocumension. Ocumension will be responsible for funding the clinical development of EyePoint’s three-year micro-insert product using the Durasert technology for chronic, non-infectious posterior segment uveitis in Greater China. EyePoint will supply product for the clinical trials.

John Landis, Ph.D., M.S., was appointed to the EyePoint Board of Directors in October 2018. Dr. Landis brings more than 30 years of pharmaceutical research and development experience from senior level roles held at Schering-Plough Corporation, Pharmacia Corporation and The Upjohn Company.

EyePoint’s Board of Directors approved a change of the Company’s fiscal year-end to December 31 from the current fiscal year-end of June 30. The Company believes this change will align its financial reporting periods to that of its peer group in the industry and better facilitate assessment of the Company’s financial performance. The Company will file transitional audited financial statements on Form 10-KT for the six-month period ending December 31, 2018.

Fiscal First Quarter 2019 Results

Revenue for the three months ended September 30, 2018 totaled $486,000 compared to $385,000 for the prior year quarter. Revenues in both periods were primarily derived from royalty income under existing collaboration agreements.

Operating expenses for the quarter ended September 30, 2018 increased to $14.0 million from $6.4 million a year earlier, due primarily to initial investments in sales and marketing infrastructure and program costs, amortization of the DEXYCU intangible asset, professional services and stock-based compensation. Non-operating expense, net in the quarter ended September 30, 2018 totaled $19.6 million and consisted primarily of a non-cash change in fair value of derivative liability and interest expense on our term loan. Net loss for the quarter ended September 30, 2018 was $33.1 million, or $0.44 per share, compared to a net loss of $6.0 million, or $0.15 per share, for the prior year quarter.

Cash and cash equivalents at September 30, 2018 totaled $55.8 million compared to $38.8 million at June 30, 2018. The cash balance of September 30, 2018 reflects proceeds of $28.9 million from the exercise of warrants in the quarter.

Conference Call Information

EyePoint will host a conference call today, Tuesday, November 6, 2018, at 8:00 AM ET, to discuss the fiscal first quarter 2019 financial results and recent clinical and operational developments. To access the conference call, please dial (877) 312-7507 (local) or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 3098959. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On November 6, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., the Company’s president and chief executive officer, will present a corporate update at the Stifel 2018 Healthcare Conference on November 13, 2018 at 9:30 a.m. ET. The conference will take place November 13-14, in New York, N.Y (Press release, MEI Pharma, NOV 6, 2018, View Source [SID1234530873]).

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A live audio webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source

An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

On November 6, 2018 Apexian Pharmaceuticals reported that Researchers will continue to explore the impact of Apexian’s target molecule, APX3330, on cancer cachexia with additional grant funding from the National Institutes of Health (NIH) National Cancer Institute (NCI). Cancer cachexia is weight loss with chronic inflammation and defective metabolism, which causes roughly one-third of all cancer deaths (Press release, Apexian Pharmaceuticals, NOV 6, 2018, View Source [SID1234530752]). It is particularly prevalent in pancreatic ductal adenocarcinoma (PDAC), which has a dismal five-year survival rate.

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Dr. Mark R. Kelley, Apexian Chief Scientific Officer and the Betty and Earl Herr Professor of Pediatric Oncology Research at the Indiana University Simon Cancer Center; Dr. Melissa Fishel, Research Associate Professor, Wells Center for Pediatric Research; and Dr. Teresa Zimmers, Associate Professor of Surgery at the Indiana University School of Medicine, have been working to define mechanisms of cachexia stemming from treatment in PDAC, as well as for identifying mechanism-driven, targeted anti-cachexia therapies.

"The goal of this research is to determine the anti-cachexia potential of Ref-1 inhibition, HIF-1a inhibition, or the combination in mouse models of PDAC," said Dr. Kelley. "APX3330 has proven effective at inhibiting Ref-1, and has been safe and well tolerated when taken by patients with advanced cancers in our Phase 1 clinical study."

Previous studies support Ref-1 as a target in PDAC, on-target effects of APX3330, and the use of APX3330 as a clinical agent in cancer. This study will focus on demonstrating improvement in fat/muscle mass and PDAC cachexia symptoms using APX3330. Positive results from this study would lead to immediate clinical trials using APX3330 to prevent or reverse PDAC cachexia.

"Dr. Kelley’s research on APX3330 as a Ref-1 inhibitor continues to offer promise as a treatment for cancer and cancer-related issues like cachexia and cancer chemotherapy-induced neuropathy," said Steve Carchedi, CEO of Apexian Pharmaceuticals. "As we complete our Phase I trial, we continue to aggressively pursue additional therapeutic uses for APX3330 and build on our pipeline of novel, first in class molecules."

The NIH grant of $227,554 pushes Kelley’s grant budget for research on Ref-1 inhibitors to nearly $700,000 just in 2018.

On November 6, 2018 Emergent BioSolutions Inc. (NYSE: EBS) reported that a member of the company’s senior management team will participate in the following investor conferences during the fourth quarter and early portion of the first quarter of 2019 (Press release, Emergent BioSolutions, NOV 6, 2018, View Source;p=RssLanding&cat=news&id=2375511 [SID1234530772]):

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JP Morgan – 2018 CEO Conference Call Series
Virtual/Conference Call (information to be provided by JP Morgan)
November 13, 2018

Three Part Advisors – 2018 Southwest IDEAS Investor Conference
Dallas, TX
November 14-15, 2018

Piper Jaffray – 30th Annual Healthcare Conference
New York, NY
November 27-29, 2018

Mizuho – Global Mizuho Investor Conference
New York, NY
December 3, 2018

BMO Capital Markets – 2018 Prescriptions for Success Healthcare Conference
New York, NY
December 12, 2018

JP Morgan – 37th Annual Healthcare Conference
San Francisco, CA
January 7-10, 2019
Presentation dates and times will be updated on the Emergent website www.emergentbiosolutions.com under "Investors" as the information becomes available.
For these conferences, the company will be webcasting its presentation, which may include a discussion of the company’s recent business developments as well as its most recently reported financial results and guidance. The webcasts will be available both live and by replay, accessible from the Emergent website.

On November 6, 2018 Alkermes plc (Nasdaq: ALKS) reported the presentation of three abstracts at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C., Nov. 9-11, 2018 (Press release, Alkermes, NOV 6, 2018, View Source;p=irol-newsArticle&ID=2375550 [SID1234530794]). Initial clinical data from the ongoing monotherapy dose-escalation stage of the phase 1 study for ALKS 4230, the company’s immuno-oncology drug candidate, will be presented for the first time. ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

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"The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while overcoming its limitations. These initial data from our phase 1 study demonstrate the unique mechanism of ALKS 4230, with dose-dependent pharmacodynamic effects on circulating natural killer cells and CD8+ T cells and minimal and non-dose dependent effects on immunosuppressive regulatory T cells," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "Based on these data from our initial monotherapy dose-escalation cohorts, we’ve accelerated the development program to include evaluation of ALKS 4230 in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA). As we continue to pursue the optimal dose of ALKS 4230 in the monotherapy setting, we are also eager to explore other regimens that may provide greater dosing flexibility for patients, and plan to initiate a study for subcutaneous dosing in early 2019."

Details of the poster presentations at SITC (Free SITC Whitepaper) are as follows:

Abstract Poster #P423: "Safety, Pharmacokinetics and Pharmacodynamic Effects of ALKS 4230 in Patients With Advanced Solid Tumors From the Ongoing Dose Escalation Portion of a First-in-Human (FIH) Study," will be presented by Ulka N. Vaishampayan, M.D., Barbara Ann Karmanos Cancer Institute
ALKS 4230 was assessed in 24 patients with refractory solid tumors at doses ranging from 0.1 µg/kg/day to 3 µg/kg/day as part of the ongoing phase 1 study.
Treatment with ALKS 4230 resulted in a dose-dependent increase in circulating natural killer (NK) cells and CD8+ T cells with a near 4-fold and 2-fold expansion, respectively, at 3 µg/kg/day, and minimal, non-dose-dependent change in regulatory T (Treg) cells.
Fever and chills were the most common treatment-related adverse events (AEs) for ALKS 4230.
These data support the rationale for assessing ALKS 4230 at the 3 µg/kg/day dose in combination with pembrolizumab, as well as for continued dose escalation in the monotherapy setting.
Abstract Poster #P425: "Pharmacokinetics and Pharmacodynamic Effects of ALKS 4230, an Investigational Immunotherapeutic Agent, in Cynomolgus Monkeys After Intravenous and Subcutaneous Administration," will be presented by Lei Sun, Ph.D., Alkermes, Inc.
Data from two non-human primate studies demonstrated that subcutaneous administration of ALKS 4230 can achieve similar total systemic exposure of ALKS 4230 compared to intravenous administration, yet with less frequent dosing and a lower Cmax, leading to similar expansion of total CD8+ T cell and NK cell populations.
These data support further clinical evaluation of subcutaneous administration of
ALKS 4230 as an alternative to intravenous dosing.
Abstract Poster #P123: "Peripheral Blood Lymphocyte Responses in Patients With Renal Cell Carcinoma Treated With High-Dose Interleukin-2," will be presented by Wenxin Xu, M.D., Beth Israel Deaconess Medical Center
Consistent with the known biological activities of IL-2, administration of high-dose IL-2 resulted in an approximate 2-fold expansion of circulating cytotoxic effector CD8+ T cells and NK cells and an approximate 4-fold expansion of circulating Treg cells.
These data provide quantitative measures of the expansion of cytotoxic effectors such as CD8+ T cells and NK cells relative to Treg cells for high-dose IL-2, and may be useful in the future for evaluating possible differences in immune response to newer formulations of
IL-2.
Posters will be on display both Friday, Nov. 9 and Saturday, Nov. 10 beginning at 8:00 a.m. ET in Hall E of the Walter E. Washington Convention Center. For more information, including a complete list of abstracts, please visit the SITC (Free SITC Whitepaper) website at View Source

About the Phase 1 Study for ALKS 4230
The phase 1 study for ALKS 4230 includes three distinct stages: the ongoing monotherapy dose-escalation stage, the planned monotherapy dose-expansion stage and the recently initiated combination therapy stage with pembrolizumab. The dose-escalation stage is designed to determine a maximum tolerated dose of ALKS 4230 in a monotherapy setting and to identify the optimal dose range of ALKS 4230 based on measures of immunological-pharmacodynamic effects. Upon completion of the dose-escalation stage, Alkermes expects to initiate the monotherapy dose-expansion stage in patients with renal cell carcinoma or melanoma. The combination therapy stage of the phase 1 study will assess the safety profile and anti-tumor activity of ALKS 4230 with pembrolizumab in patients with select advanced solid tumors. This combination therapy stage will be run independent of, and concurrently with, the monotherapy dose-escalation and dose-expansion stages of the trial.

Anti-tumor response and duration of response assessments in the dose-expansion and combination stages of the phase 1 study will be based on investigator-assessed, immune-related response criteria(irRC) and independent, central, blinded radiographic review per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while overcoming its limitations.