Jounce Therapeutics Reports Second Quarter 2018 Financial Results

On August 9, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the second quarter ended June 30, 2018 (Press release, Jounce Therapeutics, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363021 [SID1234528610]).

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"We recently reported safety and preliminary efficacy data from our lead program, JTX-2011, at ASCO (Free ASCO Whitepaper) in June and are pleased to announce that enrollment is now underway in the dose escalation cohorts of the Phase 1/2 ICONIC trial evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab. For the broader pipeline derived from our Translational Science Platform, we remain on track to file an IND for JTX-4014 this year and are conducting IND-enabling studies for our first tumor-associated macrophage candidate," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our experienced and talented team remains focused on our key value drivers as we work to discover and develop first-in-class immunotherapies. We remain committed to interrogating the tumor microenvironment to inform and refine our clinical trials and, ultimately, impact the lives of cancer patients."

Ongoing Phase 1/2 ICONIC Trial of JTX-2011:

In June 2018, Jounce began enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab.

In June 2018, Jounce presented safety and preliminary efficacy data from its ongoing Phase 1/2 ICONIC (ICOS AgONist Antibody for Immunotherapy in Cancer Patients) trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. The Phase 1 portion of ICONIC was a dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The patients in Phase 2 received JTX-2011 0.3 mg/kg every 3 weeks alone or in combination with nivolumab 240 mg every 3 weeks. Preliminary efficacy evaluation included tumor reductions and response evaluation criteria in solid tumors (RECIST) responses. Key data included:

Safety: JTX-2011 was well tolerated alone and in combination with nivolumab 240 mg every 3 weeks. The overall safety profile observed was consistent with previously reported data from the Phase 1 portion of the ICONIC trial.

Biological and Clinical Activity: The patients with RECIST partial responses (PRs), alone and in combination with nivolumab, reported at ASCO (Free ASCO Whitepaper), remained on study with ongoing response. The RECIST PRs were seen in PD-1 inhibitor naïve patients with Gastric and Triple Negative Breast cancers. In addition, tumor reductions and stable disease have occurred including in patients with Non-Small Cell Lung cancers who are PD-1 inhibitor failures.

Biomarkers: In a preliminary analysis of evaluable fresh pre-treatment biopsies, rates of disease control and tumor reduction appear higher in subjects with high ICOS scores. A potential ICOS pharmacodynamic biomarker (emergence of a peripheral blood ICOS high CD4 T cell population) that appears to associate with anti-tumor activity has been identified.
Additional Pipeline Highlights:

Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in the second half of 2018.

In March 2018, Jounce advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $232.7 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter, offset by the receipt of state and federal income tax refunds.

Collaboration Revenue: Collaboration revenue was $19.4 million for the second quarter of 2018, compared to $20.3 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene. Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, which was adopted in the first quarter of 2018, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene. Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Research and Development (R&D) Expenses: R&D expenses were $18.5 million for the second quarter of 2018, compared to $17.2 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.0 million in increased employee compensation costs related to increased headcount and $0.2 million in increased external research and development costs primarily attributable to IND-enabling activities related to JTX-4014.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the second quarter of 2018, compared to $6.1 million for the same period in 2017. The increase in G&A expenses was primarily due to increased stock-based compensation expense.

Net Loss: Net loss was $4.7 million for the second quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.14. Net loss was $3.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.11. The increase in net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the second quarter of 2017 to the second quarter of 2018.
Financial Guidance:

In March 2018, Jounce provided gross cash burn guidance for 2018 of $80.0 to $100.0 million. This cash burn projection excluded any tax refund impact. During the second quarter of 2018, Jounce received tax refunds of $16.8 million relating to taxes previously paid on the Celgene upfront payment. These refunds resulted from a change in tax accounting method elected as a result of the Tax Cuts and Jobs Act of 2017.

Jounce expects to now be at the lower end of the gross cash burn guidance previously provided and expects to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8881737. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue, cash burn and other financial results, the timing and progress of the Phase 1/2 ICONIC trial, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

argenx to Present at 2018 Wedbush PacGrow Healthcare Conference

On August 9, 2018 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that the Company will present on Tuesday, August 14th at 1:20 p.m. ET at the 2018 Wedbush PacGrow Healthcare Conference in New York (Press release, argenx, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363190 [SID1234528607]).

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A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.

GlycoMimetics Reports Second Quarter 2018 Results and Highlights Recent Company Achievements

On August 9, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the second quarter ended June 30, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, AUG 9, 2018, View Source [SID1234528603]). Quarter-end cash at June 30, 2018 was $229.4 million.

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"Our second-quarter 2018 accomplishments reflect significant progress as we finalized our plans to conduct a comprehensive Phase 3 development program for uproleselan across the spectrum of AML. With our announcement in May of an NCI CRADA, in addition to the previously announced trial in Europe sponsored by the prestigious HOVON consortium and our own sponsored registration trial, we are now planning three separate randomized, controlled trials, which we believe should provide clear efficacy and safety outcome measures in each of settings being evaluated," said Rachel King, GlycoMimetics Chief Executive Officer. "The unique mechanism of action of uproleselan allows for the potential treatment of not only relapsed/refractory AML patients, but also older, newly diagnosed AML patients who are considered to be either fit or unfit for intensive chemotherapy. If successful, we believe that the combination of these trials could position us to offer a new standard treatment across the continuum of care in AML."

Key Operational Highlights for the Second Quarter of 2018:

The company’s agreement with the NCI, part of the National Institutes of Health (NIH), provides for GlycoMimetics to collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. The trial will be funded by the NCI. GlycoMimetics will provide uproleselan as well as financial support to augment data analysis and monitoring. Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, will lead this Phase 3 trial. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.
At the AACR (Free AACR Whitepaper) annual meeting, the company highlighted data from preclinical models of selected cancers in which uproleselan and GMI-1359, a dual antagonist of E-selectin and CXCR4, exhibited anti-cancer activity. Key findings from the preclinical research include:
Uproleselan could potentially be used with a hypomethylating agent, such as 5-azacitidine, to treat AML patients not healthy enough for intensive chemotherapy.
GMI-1359 mobilized tumor-reactive T-cells from bone marrow, which could enhance effectiveness of treatments despite tumor resistance.
Both tumor growth and metastasis of osteosarcoma to lung tissue were reduced with GMI-1359 treatment.
The company’s strategic partner Pfizer continues to enroll individuals with sickle cell disease (SCD) in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer has advised GlycoMimetics that enrollment is approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
Second Quarter 2018 Financial Results:

Cash position: As of June 30, 2018, GlycoMimetics had cash and cash equivalents of $229.4 million as compared to $123.9 million as of December 31, 2017. In March 2018, GlycoMimetics completed a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.3 million for the quarter ended June 30, 2018 as compared to $5.7 million for the prior year quarter. The increase was primarily due to higher manufacturing costs for uproleselan clinical supplies as the Company prepares for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties. This increase was offset in part by a decrease in clinical trial expenses as patient enrollment for our Phase 1/2 clinical trial of uproleselan was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended June 30, 2018 as compared to $2.5 million for the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of June 30, 2018 were 43,055,424.
The company will host a conference call and webcast tomorrow, Friday, August 10, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 3876308. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About Uproleselan (GMI-1271)

Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The FDA has granted uproleselan Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics plans to implement a comprehensive development program across the clinical spectrum of AML. This will include a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial will be sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial will be sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is VOC of SCD, one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma (MM) or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.

Alpine Immune Sciences Provides Corporate Update and Reports Second Quarter 2018 Financial Results

On August 9, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune/inflammatory, and other diseases, reported financial results for the second quarter ended June 30, 2018 (Press release, Alpine Immune Sciences, AUG 9, 2018, View Source [SID1234528602]).

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"During the first six months of this year, we continued to execute with important advancements that support taking our programs into clinical trials," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Our lead program ALPN-101, a dual ICOS/CD28 antagonist for the treatment of autoimmune/inflammatory disease, is rapidly advancing toward our company’s first human clinical trials. Our lead oncology program, ALPN-202, is a novel molecule designed to block the inhibitory immune checkpoints PD-L1 and CTLA-4, and to provide PD-L1-dependent T cell activation via the CD28 costimulatory receptor. Together, we believe these two molecules place Alpine on the cusp of the next generation of immunotherapy. I’m also excited about the addition of Mark Litton as President and Chief Operating Officer, which comes at an important time for Alpine. I am confident we have the right people and strategy in place as we work to deliver meaningful value to our investors over the long term."

Corporate Development Highlights

Appointed Mark Litton President and Chief Operating Officer: On August 6, 2018, Alpine announced the appointment of Mark Litton, Ph.D. as President and Chief Operating Officer. Dr. Litton, a veteran life sciences executive, was previously co-founder and Chief Business Officer at Alder Biopharmaceuticals, where he oversaw all business operations, including playing an integral role in Alder’s initial public offering and subsequent financings, as well as high-profile collaborations and partnerships.
Completed sale of GSNOR Assets to Laurel Venture Capital: On July 20, 2018, Alpine announced the completion of the sale and transfer of global rights to the S-Nitrosoglutathione Reductase (GSNOR) assets to Laurel Venture Capital (Laurel). The assets include broad intellectual property around small molecule GSNOR inhibitors, including a product candidate for severe asthma and COPD demonstrating safety and efficacy in preclinical and clinical studies. As a result of the transaction, Alpine received an upfront payment and is eligible for potential milestones and royalty payments. Alpine acquired GSNOR assets as part of its merger with Nivalis Therapeutics, Inc. in 2017.
Advanced both lead programs towards the clinic: ALPN-101 remains on track to advance to clinical trials and we anticipate completing in the fourth quarter of 2018 all tasks necessary to commence clinical trials. ALPN-202 pre-clinical development activities continue as planned with the goal of human clinical trials starting in 2019.
Second Quarter 2018 Financial Results

Alpine ended the second quarter of 2018 with $69.9 million in cash, cash equivalents and short-term investments, compared to $81.2 million as of December 31, 2017. Net cash used in operations for the six months ended June 30, 2018 was $11.6 million, compared to $6.0 million for the six months ended June 30, 2017.
Revenue for the second quarter of 2018 was $0.4 million, compared to $0.7 million in the second quarter of 2017. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, a Gilead (NASDAQ:GILD) company.
Research and development expenses for the second quarter of 2018 were $5.7 million, compared to $2.3 million for the same period in 2017. The increase was primarily attributable to an increase in direct research, contract manufacturing and process development activities in addition to personnel-related expenses, overhead and facilities.
General and administrative expenses for the second quarter of 2018 were $1.9 million, compared to $2.1 million for the same period of 2017. The decrease was primarily attributable to a decrease in professional and legal service fees related to merger costs incurred during the 2017 period, partially offset by an increase in personnel-related expenses and costs incurred to support the growth and expansion of the business.
Loss on sale of intangible asset relates solely to the sale of the GSNOR assets to Laurel in June 2018.
Cash Guidance

The company expects to have sufficient cash to fund operations into 2020, including the clinical advancement of ALPN-101 for the treatment of autoimmune/inflammatory diseases and ALPN-202 for the treatment of cancer.

Omeros Corporation Reports Second Quarter 2018 Financial Results

On August 9, 2018 Omeros Corporation (NASDAQ: OMER) reported recent highlights and developments as well as financial results for the second quarter ended June 30, 2018, which include (Press release, Omeros, AUG 9, 2018, View Source [SID1234528601]):

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2Q 2018 total and OMIDRIA revenues were $1.7 million, compared to $17.2 million in 2Q 2017; the decrease was due to the significantly reduced usage of OMIDRIA by ambulatory surgery centers (ASCs) and hospitals during the period (January 1, 2018 through September 30, 2018) in which transitional pass-through reimbursement for OMIDRIA is unavailable. Pass-through status for OMIDRIA will reinitiate on October 1, 2018 and is scheduled to remain in effect through September 30, 2020.
Net loss in 2Q 2018 was $33.7 million, or $0.70 per share. Non-cash expenses for 2Q 2018 were $4.6 million, or $0.10 per share.
At June 30, 2018, the company had cash, cash equivalents and short-term investments available for operations of $88.4 million.
Successful meetings held with the U.S. Food and Drug Administration (FDA) and a European regulatory agency focused on pathways to accelerated, conditional and full approval for OMS721 in "high-risk" stem cell transplant-associated thrombotic microangiopathy. Interactions with U.S. and European regulatory agencies are ongoing and the company continues preparations for Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions.
Settled patent infringement lawsuit against Lupin on favorable terms in May 2018, and patent infringement lawsuit against Sandoz was dismissed in July 2018 because Sandoz stipulated to no longer pursue its Abbreviated New Drug Application (ANDA) prior to OMIDRIA patent expiration in 2033, resolving all litigation with ANDA filers.
In July 2018, the first patient was dosed in the Phase 1 clinical trial for Omeros’ lead phosphodiesterase 7 (PDE7) inhibitor OMS527. Dosing has been completed in the first two cohorts of this Phase 1 clinical trial and to date the drug remains well-tolerated.
"During the last quarter, we made significant strides across multiple fronts," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "For OMS721, our MASP-2 inhibitor, Phase 3 clinical trials are advancing in both IgA nephropathy and aHUS, and our stem-cell TMA program is moving toward regulatory filings for marketing approval in both the U.S. and Europe. Our PDE7 inhibitor OMS527 is demonstrating good drug behavior in its Phase 1 clinical trial. We are also excited about our MASP-3 inhibitor OMS906, our MASP-2 small molecules for oral administration and our multiple GPCR cancer therapeutic programs, all of which look promising and are slated to begin entering the clinic as early as late 2019. And to help fund our pipeline’s continuing progress, OMIDRIA is rapidly approaching its return to pass-through status on October 1. All of the pieces appear to be coming together, and we look forward to realizing the near- and long-term prospects for Omeros."

Second Quarter and Recent Developments

Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include:
The company recently held successful meetings with the FDA and a European regulatory agency covering pathways to accelerated, conditional and full approval for OMS721 in "high-risk" HSCT-TMA. Interactions with U.S. and European regulatory agencies are ongoing and the company continues preparations for BLA and MAA submissions.
Omeros announced in April 2018 that the FDA granted breakthrough therapy designation to OMS721 for the treatment of patients with "high-risk" HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation from FDA for the treatment of IgA nephropathy.
In April 2018, Omeros reported new results in patients with HSCT-TMA from the ongoing OMS721 Phase 2 study. The analysis of 100-day mortality, an important endpoint previously used as an approval endpoint in another condition related to HSCT, showed that OMS721-treated patients had improved survival relative to the historical control (53% vs 10%; p = 0.0002).
Dosing in the U.S. cohort has been completed in the placebo-controlled portion of the company’s Phase 2 trial of OMS721 in IgA nephropathy. Data are expected in September.
In July 2018, the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation. The positive opinion is expected to be adopted by the European Commission in August.
Developments regarding OMIDRIA include:
In the recently released 2019 proposed rule for the Centers for Medicare & Medicaid Services’ (CMS’) outpatient prospective payment system (OPPS), CMS indicated that it will separately pay in the ASC setting for non-opioid drugs with an FDA-approved indication for postoperative pain relief. Although not specifically named, Omeros believes that OMIDRIA meets this definition.
Commercial activities have been focused on re-engaging and expanding ASC and hospital customers in anticipation of the recommencement of Medicare Part B separate payment beginning October 1, 2018 through September 30, 2020.
In May 2018, the company entered into a settlement agreement and consent judgment with Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin) concerning Lupin’s filing of an ANDA seeking approval from the FDA to market a generic version of OMIDRIA. A similar settlement was reached with Par Pharmaceutical late last year. In July 2018, the company announced that its patent infringement lawsuit against Sandoz Inc. (Sandoz) had been dismissed by stipulation of the parties. All of Omeros’ litigation with ANDA filers has now been favorably concluded. The earliest ANDA entry date for any of the three generic manufacturers is April 2032 unless otherwise subsequently authorized pursuant to the settlement agreements.
In July 2018, Omeros reported that OMIDRIA had been made available in the European Union (EU) on a limited basis, which maintained the ongoing validity of the European marketing authorization for OMIDRIA.
OMIDRIA was added to the Veterans Health Administration (VA) National Formulary in April 2018.
In April 2018, Omeros announced that the results of four "real-world" clinical studies were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting. The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
In Omeros’ PDE7 program, the company is developing proprietary compounds to treat addiction and compulsive disorders as well as movement disorders. In June 2018, Omeros reported that it had obtained regulatory authority and ethics committee clearance to start the Phase 1 clinical trial evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of its lead PDE7 inhibitor, OMS527, in healthy subjects. Dosing has been completed in the first two cohorts of this Phase 1 clinical trial and to date, the drug remains well-tolerated. Data are expected in the first half of 2019. The initial target planned for OMS527 is nicotine addiction.
As reported previously, the company’s credit facility with CRG was amended in April 2018 to eliminate the revenue and market capitalization covenants with respect to the 12-month period ending on December 31, 2018 and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (i.e., $375.0 million based on June 30, 2018 borrowings) on the applicable determination date. In May 2018, the company borrowed the remaining $45.0 million available under this facility.
Financial Results

For the quarter ended June 30, 2018, revenues were $1.7 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $17.2 million for the same period in 2017. The decrease in revenue from the comparable quarter in 2017 was due to the significantly reduced usage of OMIDRIA by ASCs and hospitals during the period (January 1, 2018 through September 30, 2018) in which transitional pass-through reimbursement for OMIDRIA is unavailable. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $0.1 million from the $1.6 million achieved in the first quarter of 2018. Pass-through status for OMIDRIA will reinitiate on October 1, 2018 and is scheduled to remain in effect through September 30, 2020.

Total costs and expenses for the three months ended June 30, 2018 were $32.3 million compared to $29.1 million for the same period in 2017. The increase in the current year quarter was primarily due to higher manufacturing scale-up costs for the OMS721 programs and to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial. These increases were partially offset by decreased OMIDRIA patent litigation costs.

For the three months ended June 30, 2018, Omeros reported a net loss of $33.7 million, or $0.70 per share, which included non-cash expenses of $4.6 million ($0.10 per share). In comparison, for the prior year’s second quarter Omeros reported a net loss of $14.4 million, or $0.33 per share including non-cash expenses of $4.3 million ($0.10 per share).

As of June 30, 2018, the company had $88.4 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments. This includes the remaining $45.0 million available under the company’s existing credit facility, which was drawn down in May 2018.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 3989669. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3989669.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.