On August 8, 2019 Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2019 and provided an update on its programs (Press release, Synlogic, AUG 8, 2019, View Source [SID1234538443]).

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"In the first half of the year we made significant advances in our Synthetic Biotic programs while strengthening our platform capabilities and our balance sheet," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "We look forward to an equally productive second half of the year as we continue to advance our novel Synthetic Biotic medicines to provide potential therapeutic solutions for patients with unmet medical needs."

Recent Highlights and Updates

Positive topline clinical data from phenylketonuria (PKU) patient cohorts in Phase 1/2a clinical trial enable next stage of clinical development of new solid formulation of SYNB1618. In July, Synlogic announced positive top-line clinical data demonstrating safety and tolerability of a liquid formulation of SYNB1618 in patients with PKU. Importantly, the data also demonstrated that production of biomarkers related to SYNB1618’s engineered ability to consume phenylalanine (Phe) was equivalent in patients and healthy volunteers. Synlogic has initiated a bridging study in healthy volunteers to evaluate the activity and maximum tolerated dose of a solid oral formulation of SYNB1618 manufactured by the company using an improved fermentation process. Full data and a description of the model will be presented at the annual symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Rotterdam, September 3-6, 2019.
Expanded collaboration with Ginkgo Bioworks provides expanded synthetic biology capabilities and strengthens Synlogic balance sheet. In June, Synlogic and Ginkgo entered into a long-term strategic platform collaboration. Under the agreement Ginkgo invested $80.0 million in Synlogic at a premium to market. Synlogic will use Ginkgo’s cell programming platform for building and testing thousands of microbial strains to accelerate progression of early preclinical leads to drug candidates optimized for further clinical development. Synlogic paid $30.0 million to Ginkgo for synthetic biology services to be provided over an initial period of five years which can be extended. Synlogic has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to intellectual property covering such products.
Establishment of clinical collaboration with Roche will enable evaluation of SYNB1891, engineered to express a STING agonist, in combination with PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced solid tumors. Synlogic remains on track to file an Investigational New Drug application with the U.S. Federal Drug Administration in the second half of 2019 for SYNB1891 to enable the company to initiate an open-label Phase 1 clinical trial to evaluate the candidate as a monotherapy and a combination treatment with atezolizumab.
Appointment of Scott Plevy, M.D., as Chief Scientific Officer to lead Synlogic’s research organization. Dr. Plevy is a gastroenterologist who most recently served as Vice President, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, LLC, after a successful career in academia. He has a wealth of experience in early-phase clinical trials and performed translational research to advance the understanding of novel immunologic interventions in inflammatory bowel disease, other inflammatory conditions, and microbiome-related diseases.
Second Quarter 2019 Financial Results
As of June 30, 2019, Synlogic had cash, cash equivalents and short and long-term investments of $149.1 million.

In June 2019, Synlogic issued to Ginkgo 6,340,771 shares of common stock at a purchase price per share of $9.00, and pre-funded warrants to purchase an aggregate of 2,548,117 shares of common stock at an exercise price of $9.00 per share, with $8.99 of such exercise price paid at the closing of the offering. The net proceeds to Synlogic were approximately $79.9 million.

For the three months ended June 30, 2019, Synlogic reported a consolidated net loss of $12.3 million, or $0.45 per share, compared to a consolidated net loss of $14.6 million, or $0.59 per share, for the corresponding period in 2018.

Research and development expenses were $9.7 million for the three months ended June 30, 2019 compared to $10.9 million for the corresponding period in 2018. The decrease was primarily due to decreased clinical development costs for its SYNB1618 program and a decrease in nonclinical development costs for its programs, partially offset by increased research and development support costs.

General and administrative expenses for the three months ended June 30, 2019 were $3.7 million compared to $4.7 million for the corresponding period in 2018. The decrease was primarily due to a decrease in compensation costs and other employee-related expenses.

Revenues were $0.4 million for the three months ended June 30, 2019, compared to $0.3 million for the corresponding period in 2018. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease.

Six-months Results
For the six months ended June 30, 2019, the consolidated net loss was $25.3 million, or $0.96 per share, compared to a consolidated net loss of $25.8 million, or $1.14 per share, for the corresponding period in 2018.

Total operating expenses were $27.5 million for the six months ended June 30, 2019, compared to $27.6 million for the corresponding period in 2018.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 5:00 pm ET today, Thursday, August 8, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 6968273. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On August 8, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2019 (Press release, NantHealth, AUG 8, 2019, View Source [SID1234538461]).

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"Our 2019 second quarter represents the fourth consecutive quarter of total revenue growth," said Bob Petrou, Chief Financial Officer of NantHealth. "We generated strong topline growth and substantial gross margin improvement, which was largely driven by continued positive momentum in our Software and SaaS business, and the continuation of cost management throughout the company."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q2, at America’s Health Insurance Plans (AHIP) Institute & Expo 2019, showcased Eviti Connect, the company’s evidence-based treatment intelligence and web-based oncology decision support platform
In Q2, as previously announced, signed and launched a three-year partnership with CareSource, a leading nonprofit multi-state health plan, expanding Eviti Connect’s total covered lives to over 25 million
In Q2, released v7.8 with Smart Regimen Search, an enhancement that expedites treatment plan entry via intelligent regimen driven drug matches
Payer Engagement (NaviNet):
In Q2, at America’s Health Insurance Plans (AHIP) Institute & Expo 2019, showcased NaviNet Open, the company’s secure, multi-payer platform that lets payers and providers exchange vital administrative and clinical information
In Q2, released a number of enhancements to the NaviNet Open Authorization application, which enable the company’s health plans to offer more configuration options. These include reducing the need for manual intervention via phone and fax processes and saving providers time managing their authorization requests, speeding up delivery of care
In Q2, launched the NaviNet API Gateway, which allows the company’s partners to interact directly with its API’s in a standard method, reducing the reliance on custom integration methods and enabling payer flexibility for their provider networks
Connected Care (DeviceConX):
In Q2, at the 2019 HIMSS and Health 2.0 European Conference, participated in the first-ever U.S. Pavilion where the company showcased DeviceConX, HBox and VitalsConX to Europe’s eHealth decision makers
In May, at Vitalis, the largest e-health event in Scandinavia, presented the company’s latest connected care solutions and sponsored the Intelligent Hospital Pavilion (IHP), where the company demonstrated its latest DeviceConX 5.15 medical device integration solution
In August, entered into a memorandum of understanding with ASCO (Free ASCO Whitepaper)M to provide the company’s Denmark client increased visibility of their device parameters. The combined capabilities provide clinicians with increased visibility of intelligent alert notifications, driving more informed decisions at the point of care, closing digital information gaps and allowing for the best possible decisions throughout the hospital ecosystem
Sequencing and Molecular Analysis – Highlights:

In Q2, total GPS orders were 136, comprised of 86 GPS Cancer and 50 Liquid GPS
In Q2, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, scientific teams from NantHealth and NantOmics presented:
With collaborators from Virginia Commonwealth University (VCU), "Tumor mutation burden and PD-L1 expression in SDH/FH mutated solid tumors," which support, for the first time, a potential therapeutic role for inhibition of PD-1/PD-L1 pathway in these tumors
With collaborators from the University of California, San Diego (UCSD), "Evidence for selective silencing of MHC-binding neoepitopes to avoid immune surveillance," which can inform the development of effective immunotherapy and cancer vaccine strategies
In Q2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, scientific teams from NantHealth and NantOmics presented:
With collaborators from Duke University and the Sarcoma Center of Southern California, "Enhanced expression of human cyclin G1 (CCNG1) gene in metastatic cancer, a novel biomarker in development for CCNG1 inhibitor therapy," which may position CCNG1 as a companion diagnostic for the Delta Rex-G drug
A study entitled "The genomic and transcriptomic landscape of left versus right sided breast cancer in 410 cases," which sheds new light on ESR1 signaling in right sided breast cancers
Business and Financial Highlights

For the 2019 second quarter, total net revenue was $25.7 million, compared with $22.0 million in the 2018 second quarter. Gross profit was $15.9 million, or 62% of total net revenue, compared with $11.5 million, or 52% of total net revenue, for the prior year period. Selling, general and administrative expenses declined to $15.2 million, from $18.4 million in 2018 second quarter. Research and development expenses decreased to $4.6 million from $5.9 million.

Financial results for the second quarter of 2019 included non-cash charges for loss from related party equity method investment of $2.2 million. Net loss from continuing operations, net of tax, was $14.7 million, or $0.13 per share, compared with $21.8 million, or $0.20 per share, for the 2018 second quarter. Net loss (including discontinued operations) was $14.7 million, or $0.13 per share, compared with $23.4 million, or $0.21 per share, for 2018 second quarter.

On a non-GAAP basis, net loss from continuing operations, which excludes the losses from our related party equity investment of $2.2 million, an intangible asset impairment charge of $4.0 million, and a gain from change in the fair value of the Bookings Commitment liability of $1.0 million, among other things, was $4.4 million, or $0.04 per share, down from $11.1 million, or $0.10 per share, for the second quarter of last year.

On August 8, 2019 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported financial results for the second quarter ended June 30, 2019 and highlights recent activity (Press release, Immunic, AUG 8, 2019, View Source [SID1234538477]).

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"The April closing of our transaction with Vital Therapies, listing on The Nasdaq Capital Market and capital infusion of $30 million from a key investor syndicate, have strengthened the company, increased our visibility and allowed the team to meaningfully progress and soon expand our product pipeline," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "The pace of our recent activity and anticipated milestones testifies to these efforts. As previously reported, we expect to announce the findings from our interim dosing analysis of IMU-838 as part of the CALDOSE-1 phase 2 study in patients with moderate-to-severe ulcerative colitis during the third quarter of 2019. We expect that this data will inform dose selection for the CALDOSE-2 phase 2 trial of IMU-838 in Crohn’s disease patients, expected to begin during the second half of the year. Further, we plan to dose the first healthy volunteer as part of our phase 1 single and multiple ascending dose trials of IMU-935, directed by our Australian subsidiary, during September. Additional key inflection points are expected to follow next year."

Second Quarter 2019 and Subsequent Highlights:

July 2019: Appointed Sanjay S. Patel, CFA, as Chief Financial Officer, succeeding Interim Chief Financial Officer, Tamara A. Seymour, MBA.
June 2019: Presented previously unpublished preclinical data at the GI Inflammatory Diseases Summit in Boston confirming that IMU-838, currently in phase 2 clinical development for the treatment of ulcerative colitis (UC) and relapsing-remitting multiple sclerosis (RRMS), appears selective towards high producer T cells and acts in a synergistic fashion with current anti-TNFa antibodies, such as infliximab.
June 2019: Filed an 8-K/A containing certain financial statements and pro forma financial information related to the transaction between the company (formerly named Vital Therapies, Inc.) and Immunic AG, which closed on April 12, 2019. An updated review of Immunic’s key development programs was also provided.
June 2019: Presented newly available preclinical data at the 2nd Conference on Molecular Mechanisms of Inflammation in Trondheim, Norway, confirming IMU-935 as a highly potent small molecule inverse agonist of RORγt with additional activity on DHODH – which was shown to lead to a strong synergism on the reduction of pro-inflammatory cytokine release and to potent inhibition of Th17 differentiation while allowing normal thymocyte maturation.
April 2019: Completed stock-for-stock exchange transaction between the company (formerly named Vital Therapies, Inc.) and Immunic AG, and listed on The Nasdaq Capital Market. Concurrently, raised $30 million from an investor syndicate including LSP, Omega Funds, Fund+, LifeCare Partners, Bayern Kapital, High-Tech Gründerfonds and IBG Beteiligungsgesellschaft Sachsen-Anhalt.
Upcoming Anticipated Clinical Milestones

Patient enrollment in Immunic’s phase 2 CALDOSE-1 dose-finding trial of IMU-838 in patients with moderate-to-severe UC is expected to conclude during the second half of 2020 with top-line data expected to be available in the first quarter of 2021. An interim dosing analysis, which will inform the dose selection for the company’s CALDOSE-2 trial, is expected in the third quarter of 2019.
Initiation of the phase 2 CALDOSE-2 dose-finding trial of IMU-838 for the treatment of active Crohn’s disease (CD) is on track to begin in the second half of 2019.
Patient recruitment in Immunic’s phase 2 EMPhASIS trial of IMU-838 in RRMS is expected to conclude in the first half of 2020, with top line data expected to be available in the third quarter of 2020.
A phase 1, double-blind, placebo-controlled, single ascending dose trial of IMU-935 is expected to begin in September 2019. A phase 1, multiple ascending dose trial of IMU-935 is expected to follow and management expects to extend these studies in the first half of 2020 to assess safety and mechanism-related biomarkers in psoriasis patients.
An investigator-sponsored trial of IMU-838 in patients with primary sclerosing cholangitis, being conducted by the Mayo Clinic, is expected to begin enrollment in the second half of 2019.
Financial and Operating Results

Research and Development (R&D) Expenses were $6.0 million for the three months ended June 30, 2019, compared to $2.2 million for the same period ended June 30, 2018. The increase was primarily attributable to i) higher external clinical development costs for the company’s IMU-838 program of $1.9 million and ii) a contingent payment, triggered by the exchange agreement, under the asset purchase agreement with 4SC AG settled in stock valued at $1.5 million.

For the six months ended June 30, 2019, R&D expenses were $9.4 million, compared to $3.9 million for the same period ended June 30, 2018. The increase is primarily due to i) higher external development costs for the IMU-838 program of $3.0 million, and ii) a contingent payment under the asset purchase agreement with 4SC AG, triggered by the exchange agreement with Immunic AG, settled in stock valued at $1.5 million.
General and Administrative (G&A) Expenses were $9.0 million for the three months ended June 30, 2018, compared to $0.5 million for the period ended June 30, 2018. The increase is primarily attributable to i) one-time costs related to the exchange agreement transaction, including $6.4 million of stock-based compensation for the company’s executives, key employees and members of the board of directors and $1.2 million in transaction costs related to the stock-for-stock exchange transaction with Immunic AG, and ii) $0.6 million of public company expenses.

For the six months ended June 30, 2019, G&A expenses were $10.3 million, compared to $1.0 million for the period ended June 30, 2018. The increase is primarily due to i) one-time costs related to the exchange transaction including $6.4 million of stock-based compensation for the company’s executives, key employees and members of the board of directors and $1.7 million of transaction costs, and ii) $0.6 million of public company expenses.
Other Income for the three months ended June 30, 2019 was $0.3 million compared to none for the three months ended June 30, 2018. The increase is primarily due to reimbursement of research and development expenses in connection with the company’s option and license agreement with Daiichi Sankyo Co., Ltd.

Other income for the six months ended June 30, 2019 was $0.6 million compared to $24,000 in the same period of 2018. The increase is primarily due to $0.5 million in reimbursement of research and development expenses in connection with the aforementioned option and license agreement with Daiichi Sankyo Co., Ltd.
Net Loss for the three months ended June 30, 2019 was approximately $14.7 million, or $1.52 per basic and diluted share, based on 9,669,129 weighted average common shares outstanding, compared to a net loss of approximately $2.7 million, or $3.15 per basic and diluted share, based on 846,953 weighted average common shares outstanding for the three months ended June 30, 2018.

Net loss for the six months ended June 30, 2019 was approximately $19.0 million, or $3.60 per basic and diluted share, based on 5,282,412 weighted average common shares outstanding, compared to a net loss of approximately $4.9 million, or $5.83 per basic and diluted share, based on 846,953 weighted average common shares outstanding for the six months ended June 30, 2018. Substantially all of the company’s operating losses have resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with operations.
Cash and Cash Equivalents, as of June 30, 2019, of $36.1 million is expected to fund the company’s operations into the third quarter of 2020.

On August 8, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the second quarter of 2019 and recent operational highlights (Press release, Atara Biotherapeutics, AUG 8, 2019, View Source [SID1234538412]).

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"I am confident we are now in a strong position to execute and create value across our tab-cel, multiple sclerosis and next-generation CAR T programs," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "We believe our updated tab-cel development strategy, focusing on initiating an EBV+ PTLD regulatory submission first in the United States, prioritizes the most attractive market for such an ultra-rare disease and advances our mission to bring transformative T-cell immunotherapies to patients in critical need. In addition, we are encouraged by the initial safety results from our ongoing ATA188 Phase 1 study for patients with progressive MS and look forward to presenting the initial efficacy results from this study in September. We also strengthened our financial position, funding planned operations into 2021 and through key milestones next year including initiating the tab-cel BLA submission and next-generation mesothelin CAR T IND."

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Atara continues to progress tab-cel Phase 3 development for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disease (EBV+ PTLD).
Based on discussions with the U.S. Food & Drug Administration (FDA), Atara plans to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020.
In the United States and Australia, 34 sites are available for enrollment and the company is preparing to open additional sites in the United States, Europe and Canada.

We continue to see strong tab-cel investigator, physician and patient interest and, in cases where we are not able to enroll patients in our EBV+ PTLD Phase 3 clinical studies, we are providing tab-cel to patients in need under our early access and single patient use programs.

Atara is in discussions with the European Medicines Agency (EMA) and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization (CMA) application for patients with EBV+ PTLD.

Studies supporting potential additional tab-cel indications are also advancing.
A Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) is currently enrolling.
Atara expects to initiate a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020.

ATA188 & ATA190 for Multiple Sclerosis (MS)

A Phase 1 clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive MS is ongoing across clinical sites in the United States and Australia.
Initial ATA188 Phase 1 safety results for patients with progressive MS were presented at the 5th Congress of the European Academy of Neurology (EAN). The first three ATA188 dose cohorts were well tolerated with no dose-limiting toxicities and no ≥3 grade treatment-related, treatment-emergent adverse events.
Atara plans to present initial efficacy and additional safety results from this study at the 35thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) to be held September 11-13 in Stockholm, Sweden.
A randomized, double-blind, placebo-controlled Phase 1b part of this study using the recommended Phase 2 dose (RP2D) is now planned following completion of the open-label, dose-escalation period.

Atara expects to initiate a randomized study of autologous ATA190 in progressive MS patients during the second half of 2019.

Next-Generation CAR T

Positive Phase 1 clinical results for a mesothelin-targeted CAR T immunotherapy in patients with advanced mesothelioma were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019.
Memorial Sloan Kettering Cancer Center (MSK) collaborators presented results demonstrating that their regionally delivered mesothelin-targeted, autologous CAR T cells were well tolerated and showed encouraging anti-tumor activity in combination with pembrolizumab, a PD-1 checkpoint inhibitor.
In a subset of 16 malignant pleural mesothelioma patients with minimum follow-up time of 3 months who also received pembrolizumab and lymphodepleting chemotherapy, 12-month overall survival was 80% and best overall response rate was 63%, including 3 investigator-assessed complete responses.

Atara prioritized the mesothelin-targeted next-generation CAR T program, with an IND planned for autologous ATA2271 in advanced mesothelioma in 2020.

Corporate

Pascal Touchon was appointed President, Chief Executive Officer and member of the Board of Directors. Prior to joining Atara in June, Dr. Touchon served as Novartis Oncology Global Head, Cell & Gene and member of the Oncology Executive Committee.

Atara completed facility commissioning and qualification activities to support clinical operations at ATOM (Atara T-cell Operations and Manufacturing).
Commercial production qualification activities are nearing completion and, together with our contracted manufacturing partner, are aligned with our planned commercial strategy.

Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2019 totaled $190.1 million. In July 2019 we sold approximately 6.9 million shares of common stock and pre-funded warrants to purchase approximately 2.9 million shares of common stock for net proceeds of $140.6 million in an underwritten public offering.
The Company believes the net proceeds from the offering, together with existing cash, cash equivalents and short-term investments, are sufficient to fund planned operations into 2021.
The Company reported net losses of $74.3 million, or $1.60 per share, for the second quarter of 2019 as compared to $50.9 million, or $1.15 per share, for the same period in 2018.
Total operating expenses include total non-cash expenses of $16.9 million for the second quarter of 2019 as compared to $8.7 million for the same period in 2018.
Research and development expenses were $52.3 million for the second quarter of 2019 as compared to $33.4 million for the same period in 2018. The increase in the second quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
° clinical study, manufacturing and outside service costs related to our tab-cel, ATA188 and ATA190 programs, including strategic spending to build inventory for clinical studies and potential commercialization;
° higher employee-related and overhead costs from increased headcount and operations, and
° an increase in facilities and information technology expenses that are attributed to our research and development function.
Research and development expenses include $6.7 million of non-cash stock-based compensation expense for the second quarter of 2019 as compared to $3.4 million for the same period in 2018.
General and administrative expenses were $23.3 million for the second quarter of 2019 as compared to $19.2 million for the same period in 2018. The increase in the second quarter of 2019 was primarily due to increases in professional services costs and employee-related costs driven by increased headcount to support the Company’s expanding operations.
General and administrative expenses include $8.5 million of non-cash stock-based compensation expense for the second quarter of 2019 as compared to $4.6 million for the same period in 2018.
Conference Call and Webcast Information

Atara will host a live conference call and webcast today at 8:00 a.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 4179789. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

On August 8, 2019 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the second quarter ended June 30, 2019 (Press release, Omeros, AUG 8, 2019, View Source [SID1234538428]).

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Second Quarter 2019 Financial Highlights

OMIDRIA revenues for 2Q 2019 were a record high at $26.8 million. This compares to $21.8 million in 1Q 2019. The increase of $5.0 million, or 23 percent, over the prior quarter reflects both an expanded number of purchasing accounts and deeper penetration across Ambulatory Surgery Centers (ASCs), hospitals and the Veterans Administration and other government systems.

Net loss in 2Q 2019 was $14.5 million, or $0.29 per share, which included non-cash expenses of $6.3 million, or $0.13 per share. This compares to a net loss $24.3 million, or $0.50 per share, in 1Q 2019.

At June 30, 2019, Omeros had cash, cash equivalents and short-term investments available for operations of $31.8 million and an accounts receivable balance of $28.5 million.

In August 2019, the company entered into a $50-million revolving line of credit facility with Silicon Valley Bank. Borrowing availability is based on eligible accounts receivable, subject to applicable reserves.

Recent Business Highlights

Reached agreement with FDA on the primary endpoint criteria for the pivotal trial to support the biologics license application (BLA) for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

As part of a successful pre-BLA meeting directed to chemistry, manufacturing and controls (CMC), the company discussed with FDA the CMC requirements for the narsoplimab BLA for HSCT-TMA and is confident in its ability to meet them.

Executed a long-term commercial manufacturing agreement with Lonza in preparation for market launch of narsoplimab.

Received a product-specific permanent J-code for OMIDRIA. The J-code will become effective October 1, 2019.

"OMIDRIA revenues continue to set new quarterly records as our customer base continues to broaden throughout all channels and our per-account capture of cataract procedures grows," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Indications are that sales will continue to grow, helped in part by our new permanent J-code, broadening Med Advantage and commercial payer reimbursement, and additional strong clinical data that we believe places OMIDRIA squarely within CMS’ criteria for separate payment. As OMIDRIA ramps toward fully funding our pipeline, our assets increasingly declare their value – narsoplimab is moving toward anticipated approval and launch, OMS527 for addiction has successfully completed the Phase 1 clinical trial, OMS906 targeting the alternative complement pathway and our follow-on MASP-2 inhibitors are slated to enter the clinic beginning next year, and GPR174 inhibition appears to play a key role in cancer immunotherapy. Each of these unique and cutting-edge programs is focused on significantly improving – or saving – patients’ lives."

Other Business Updates and Developments

Recent developments regarding OMIDRIA include the following:

o In July, CMS awarded a product-specific permanent J-code for OMIDRIA, which will become effective October 1, 2019. J-codes standardize the submission and payment of insurance claims across Medicare, Medicare Advantage, Medicaid and commercial insurance plans. The J-code should allow many commercial and Medicare Advantage insurers that currently do not reimburse under the existing C-code for OMIDRIA to reimburse under the permanent J-code. Omeros’ commercial team has already initiated efforts to ensure that customers and payers are prepared to implement the new J-code.

o Two independent studies in a total of approximately 2,800 cataract surgery patients demonstrate that OMIDRIA, compared to steroids, significantly reduces the incidence of cystoid macular edema (CME) by three to twelve-fold and breakthrough iritis as well as pain/photophobia, each by approximately three-fold. The studies are expected to be submitted later this month for peer-reviewed journal publication.

o An independent investigator study shows that OMIDRIA, with statistical significance, reduces cataract surgery patients’ requirement for perioperative opioids by nearly 80 percent while reducing visual analog scale (VAS) pain scores by more than 50 percent. The study results have been selected for presentation at the meetings of the American Academy of Ophthalmology in October and a manuscript is expected to be submitted later this month for publication in a peer-reviewed journal

Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:

oAll criteria for the response-based primary endpoint in Omeros’ pivotal trial to support the BLA for narsoplimab to treat HSCT-TMA have now been finalized following agreement with FDA. The endpoint criteria are comprised of (1) laboratory markers reflecting disease progression and (2) organ function as a measure of clinical response. No additional patients are necessary for submission of the BLA. The majority of the data that comprise the BLA’s clinical module are in-house and collection of the remaining data is underway. As part of a successful pre-BLA CMC meeting the company reached agreement with FDA on the narsoplimab BLA for HSCT-TMA with respect to chemistry, manufacturing and controls. Omeros has submitted to FDA its proposed schedule for a rolling BLA and is targeting submission of the BLA’s first module by mid-next quarter.

oOmeros and Lonza, a premier global drug manufacturer, executed a long-term commercial manufacturing agreement. Omeros and Lonza have partnered since 2015 in connection with the development of narsoplimab. The new multi-year agreement secures commercial supply of narsoplimab for use following anticipated regulatory approvals.

oOmeros began meetings with the rapporteurs assigned by the European Medicines Agency to work with the company throughout the preparation and submission of the Marketing Authorization Application for narsoplimab in HSCT-TMA. Omeros plans to use the same clinical, manufacturing, and nonclinical data for approval in Europe.

oIn response to increasing physician demand, Omeros has expanded its compassionate use program for narsoplimab in HSCT-TMA. This expanded program provides patients and physicians with increased access to narsoplimab and will generate additional data useful in the drug’s planned market launch.

oOmeros’ Phase 3 trial evaluating narsoplimab for IgA nephropathy, referred to as ARTEMIS-IGAN, continues enrollment at sites in the U.S., Europe and Asia. A manuscript detailing the clinical data from the Phase 2 IgA nephropathy program has been prepared by Omeros’ Academic Leadership Committee and is being finalized for submission to a peer-reviewed journal.

o A case report will soon be submitted for publication detailing the impressive response to narsoplimab treatment by a patient who was quickly deteriorating due to IgA vasculitis-associated nephritis and rapidly progressive glomerulonephritis.

Updates regarding Omeros’ other development programs and platforms include the following:

oOmeros’ antibody against MASP-3, OMS906, continues to progress toward planned clinical entry in the first half of next year. Targeting subcutaneous dosing of once-monthly or longer, the initial focus in this program is paroxysmal nocturnal hemoglobinuria.

o As part of lifecycle planning for its MASP-2 program, Omeros is advancing development of a long-acting second-generation MASP-2 antibody targeting monthly subcutaneous delivery as well as an orally available small-molecule inhibitor of MASP-2. Both programs are slated for clinical entry by mid-2021.

o Dosing is complete in the Phase 1 trial for OMS527, the lead compound in Omeros’ phosphodiesterase 7 (PDE7) program, which targets treatment of addiction and compulsive disorders. The compound was generally well tolerated with no significant adverse events being reported. The pharmacokinetic data support once-daily dosing, with or without food. Data analysis is being finalized, and detailed study results will soon be released. Omeros plans to conduct a Phase 2a study targeting nicotine addiction.

Financial Results

2Q 2019 revenues were a record-high $26.8 million, all relating to sales of OMIDRIA. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $5.0 million, or 23 percent, from the $21.8 million achieved in 1Q 2019. The increase is due to a growing number of ASCs and hospitals using OMIDRIA for cataract surgery as well as deeper penetration within individual accounts.

Inventory on hand at wholesalers at June 30, 2019 remained consistent with historical norms. Gross-to-net deductions increased slightly from 27 percent in 1Q 2019 to 28 percent in 2Q 2019, primarily due to increased chargebacks and rebates.

Total 2Q 2019 costs and expenses were $36.1 million compared to $41.0 million for 1Q 2019. The decrease reflected reduced narsoplimab manufacturing costs, which vary from quarter to quarter depending on the timing of manufacturing development activities, partially offset by an increase in selling, general and administrative expense.

For 2Q 2019, Omeros reported a net loss of $14.5 million, or $0.29 per share, which included non-cash expenses of $6.3 million ($0.13 per share). In comparison, for 1Q 2019 Omeros reported a net loss of $24.3 million, or $0.50 per share, which included non-cash expenses of $6.0 million ($0.12 per share).

As of June 30, 2019, the company had $31.8 million of cash, cash equivalents and short-term investments available for operations. In August 2019, the company entered into a loan and security agreement under which Omeros may borrow, on a revolving basis, up to $50 million, subject to applicable reserves and an available borrowing base of eligible accounts receivable.

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 1697797. 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 1697797.

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.