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TETRAPHASE PHARMACEUTICALS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On November 8, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported financial results for the quarter ended September 30, 2018 and provided a corporate update (Press release, Tetraphase, NOV 8, 2018, View Source [SID1234531050]).

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"During the third quarter of 2018, we reached our most significant milestones as a company to date – the regulatory approvals of XERAVA for the treatment of complicated intra-abdominal infections (cIAI) in both the U.S. and Europe, followed by the commercial launch of XERAVA in the U.S. in October. We are thrilled to have accomplished these extraordinary achievements and to have made this important new antibiotic treatment available to patients in need. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI infections," said Chief Executive Officer, Guy Macdonald.

Mr. Macdonald added, "We are also pleased to have entered into a loan agreement for up to $75 million, the first $30 million tranche of which extends our cash runway into the second quarter of 2020 and provides us with additional flexibility to support a strong launch of XERAVA in the U.S. Beyond XERAVA, we look forward to milestones for our earlier-stage programs, including completion of our Phase 1 multiple ascending-dose study for oral TP-271, in development to target respiratory infections, and initiation of a bronchopulmonary disposition study for TP-6076, targeted against Acinetobacter baumannii and other MDR pathogens. As a commercial company with a focus on delivering XERAVA to patients in need, we are also continuing our pipeline efforts to develop additional antibiotic options to fight MDR infections."

Key Upcoming Milestones

Commence Phase 1 bronchopulmonary disposition study for TP-6076 – 1Q 2019
Complete Phase 1 multiple ascending-dose study for oral TP-271 – 2Q 2019
Begin phased launch of XERAVA in Europe – 1H 2019
Third Quarter and Recent Highlights

AnnouncedCommercial Launch of XERAVA for cIAI Following the U.S. Food and Drug Administration (FDA) Approval in August
The Company commercially launched XERAVA in the U.S. in October 2018. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI infections. The salesforce will be focusing on institutions responsible for treating patients in 90% of the Gram-negative marketplace.

XERAVA’s launch followed FDA approval of XERAVA in August for the treatment of cIAI in patients 18 years of age and older. Supporting XERAVA’s approval were results from two Phase 3 clinical studies that showed the therapy was well-tolerated and achieved high clinical cure rates in patients with cIAI, thus demonstrating statistical non-inferiority to two widely used carbapenems – ertapenem and meropenem.

Received Marketing Authorization from the European Commission (EC) for XERAVA in the European Union (EU)
In September, the EC adopted the July 2018 positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) to grant marketing authorization for XERAVA for the treatment of cIAI in adults in all EU member states as well as Iceland, Liechtenstein and Norway. Following this approval, the Company is on track for a phased European launch of XERAVA, beginning with Germany and the UK in the first half of 2019.

Presented XERAVA and TP-6076 Data at the Infectious Disease Society of America’s (IDSA) 2018 IDWeek
In October, the Company presented data related to XERAVA and TP-6076 at IDSA’s IDWeek. Among the data presented were results from a post-hoc analysis of XERAVA Phase 3 data, which showed high clinical cure rates and microbiological eradication with XERAVA among patients with cIAI and concurrent bacteremia. Data from a Phase 1 randomized, placebo-controlled, double-blind, multiple-ascending-dose study demonstrating positive safety, tolerability and pharmacokinetic results for the Company’s novel, fully synthetic tetracycline, TP-6076 were also presented.

Presented XERAVA Data at the American College of Clinical Pharmacy (ACCP) 2018 Global Conference
In October, the Company announced positive data from a post-hoc analysis of two Phase 3 trials of XERAVA in higher risk populations – obese patients and those with altered renal function. Similar clinical cure rates were observed for XERAVA across all classifications of renal function, further supporting that the drug is an effective empiric treatment for cIAI comparable to carbapenems which may provide an alternative to antibiotics that require dosing modification in patients with altered renal function. XERAVA was also effective in treating patients with cIAI regardless of body mass index when dosed 1mg/kg IV every 12 hours, based on total body weight when compared to carbapenems.

Entered into Loan and Security Agreement with Solar Capital Limited
In November 2018, the Company entered into a loan agreement with Solar Capital Limited providing us up to $75 million with $30 million funded at closing, to be used to support the commercial launch of XERAVA and general corporate purposes. Armentum Partners acted as advisor to the Company on the transaction.
Third Quarter 2018 Financial Results
As of September 30, 2018, Tetraphase’s cash and cash equivalents were $97 million, and there were approximately 53.5 million shares outstanding. The Company expects that its cash and cash equivalents, including the initial funding of $30 million from the debt facility, as well as expected revenue from its U.S. government awards and commercial sales of XERAVA in the U.S. and Europe, will be sufficient to fund operations into the second quarter of 2020.

Revenues during the third quarter of 2018 were $1.2 million compared to $4.1 million for the same period in 2017. Revenues for each period consisted of contract and grant revenue under the Company’s U.S. government awards for the development of Tetraphase compounds. The decrease was primarily due to the timing of activities under these awards.

Research and development (R&D) expenses for the third quarter of 2018 were $11.7 million compared to $28.8 million for the same period in 2017. The decrease in R&D expenses was primarily due to the completion of the IGNITE Phase 3 clinical studies for XERAVA.

Sales, general and administrative expenses for the third quarter of 2018 were $9.5 million compared to $5.6 million for the same period in 2017. This increase was primarily due to commercialization expenses to support the U.S. launch of XERAVA.

For the third quarter of 2018, Tetraphase reported a net loss of $19.6 million, or a loss of $0.37 per share, compared to a net loss of $30.0 million, or a loss of $0.63 per share, for the same period in 2017.

Conference Call and Webcast Information
Tetraphase will host a conference call today at 4:30 p.m. ET to discuss its financial results and provide an update on the Company. The call can be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. To access the live audio webcast, or the subsequent archived recording, visit the "Investors — Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 and by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast is available by visiting Tetraphase’s website for 90 days.

About XERAVATM

XERAVA (eravacycline) for injection is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. It is approved for use in the U.S. and Europe. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVATM Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833- 7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

Stemline Therapeutics Reports Third Quarter 2018 Financial Results

On November 8, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics, reported financial results for the quarter ended September 30, 2018 (Press release, Stemline Therapeutics, NOV 8, 2018, View Source [SID1234531049]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

ELZONRIS – Potential Approval and Pre-Commercial Activities

The FDA accepted, for filing, the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA also granted Priority Review for the BLA and set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
In preparation for potential US approval, we continue to build out our pre-launch activities. These efforts include ramping up our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
During the quarter, we conducted meetings with our assigned Rapporteurs and the European Medicines Agency (EMA). Based on feedback from these meetings, we plan to submit a Marketing Authorization Application (MAA) to the EMA for ELZONRIS in the first quarter of 2019 seeking marketing approval in Europe.
ELZONRIS – Market Expansion Efforts

ELZONRIS is being evaluated in clinical trials in additional indications, with a focus on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Based on the clinical results observed in CMML and MF thus far, we are finalizing registrational plans in these indications. We plan to seek regulatory advice in early 2019 with the goal of initiating pivotal trials, or cohorts, to follow. Ahead of this, the ongoing trial continues to enroll CMML and MF patients, and periodic updates at upcoming conferences will be provided.
ASH Conference

At the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December, ELZONRIS data were selected for four presentations, including an oral presentation. Presentations include results of the BPDCN pivotal trial and updated clinical trial data in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
Additionally, we expect to have a robust clinical, medical affairs and pre-commercial presence at ASH (Free ASH Whitepaper), including hosting an investor/analyst event on December 3rd.
SL-801

In October, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Patient enrollment and dose escalation continues. We expect to provide further updates at upcoming conferences.
SL-701

In October, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018.
Discussions around next steps to unlock potential value from the program are ongoing, and we expect to provide further updates at upcoming conferences.
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented "This is an extremely exciting time for Stemline, as we gear up for the possible approval and near-term launch of ELZONRIS for BPDCN. We have nearly completed the full build-out of our U.S. sales force and commercial infrastructure in preparation for potential launch of ELZONRIS. In parallel, we continue to generate very promising clinical data in CMML and MF, additional areas of unmet medical need. Overall, the ability to effectively target CD123 with an acceptable safety profile we believe opens up significant developmental and commercial opportunities for Stemline."

Third Quarter 2018 Financial Results Review

Stemline ended the third quarter of 2018 with $78.5 million in cash, cash equivalents and investments, representing cash use of $18.6 million in the third quarter. The Company ended the third quarter of 2018 with 31.7 million shares outstanding. For the third quarter of 2018, Stemline had a net loss of $21.0 million, or $0.73 per share, compared with a net loss of $16.1 million, or $0.68 per share, for the same period in 2017.

Research and development expenses were $11.8 million for the quarter ended September 30, 2018, compared with $12.4 million for the quarter ended September 30, 2017.

General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared with $4.2 million for the quarter ended September 30, 2017, representing an increase of $5.4 million. The higher expenses were primarily attributed to a $4.6 million increase in pre-launch expenses to support a potential commercialization of ELZONRIS in BPDCN, if marketing approval from the FDA is obtained. Additionally, the higher expense was also due to an increase in non-cash stock-based compensation and increased headcount.

About BPDCN
Please visit the BPDCN disease awareness booth (#205) at ASH (Free ASH Whitepaper) 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.

Fate Therapeutics to Present at Upcoming Investor Conferences

On November 8, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Scott Wolchko, President and Chief Executive Officer, will present at two upcoming investor conferences in November (Press release, Fate Therapeutics, NOV 8, 2018, View Source [SID1234531048]):

Jefferies 2018 London Healthcare Conference at 4:40 p.m. UTC on Thursday, November 15, 2018 in London.
Piper Jaffray 30th Annual Healthcare Conference at 12:30 p.m. ET on Tuesday, November 27, 2018 in New York City.
Live webcasts of the presentations will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcasts, an archived replay will be available on the Company’s website.

Inovio Pharmaceuticals Reports 2018 Third Quarter Financial Results

On November 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the development and commercialization of DNA immunotherapies targeted against cancers and infectious diseases, reported financial results for the third quarter ended September 30, 2018 (Press release, Inovio, NOV 8, 2018, View Source [SID1234531047]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

Inovio Highlights

VGX-3100 – HPV-related Precancers
Phase 3 trial enrollment remains ongoing and on track for REVEAL 1, with REVEAL 2 expected to begin in early 2019. To date, REVEAL 1 has opened sites across 19 countries, actively recruiting patients. Recruitment for Phase 2 studies in vulvar dysplasia and anal dysplasia is also underway. In August, Inovio entered into a partnership with the AIDS Malignancy Consortium to evaluate VGX-3100 in a multi-site Phase 2 study in HIV-positive adult men and women. Interim efficacy data from all these Phase 2 studies are expected in 2019.
MEDI0457 (formerly INO-3112, licensed to MedImmune)
The October issue of Clinical Cancer Research detailed results of a patient with head and neck cancer treated with MEDI0457 who achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor. In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma, 91% of patients (20/22) showed T cell activity in the blood or tissue. MEDI0457 is currently in a Phase 2 study to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated head and neck cancer. MedImmune is also expected to begin another Phase 2 study in the fourth quarter to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated cancers (other than head and neck). The commencement of this study will trigger a milestone payment to Inovio under the terms of the parties’ collaboration agreement.
INO-5150 – Prostate cancer
Presented prostate cancer data from Inovio’s Phase 1 study at the ESMO (Free ESMO Whitepaper) 2018 conference in which a slowing of Prostate-Specific Antigen Doubling Time (PSADT) was observed in men with prostate cancer, with 86% of patients remaining progression-free at week 72.
INO-5401 – Cancer Combination Trials
Enrollment is going as planned and is on target to report interim Phase 2 data for both glioblastoma (GBM) and bladder cancer in 2019. In both trials INO-5401 is combined with a checkpoint inhibitor – for GBM with Regeneron (PD-1); for bladder cancer with Genentech (PD-L1).
PENNVAX-GP – HIV
In August, first patient was dosed with PENNVAX-GP in a randomized clinical trial that will evaluate its ability to drive remission of HIV infection. Enrollment remains on track. The trial is part of a previously reported multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP with the goal of attaining long-term HIV remission. Inovio anticipates interim results in 2019.
INO-4700 (GLS-5300) – MERS
First patient was dosed with vaccine to prevent infection from the deadly MERS virus (Middle East Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300). The trial is ongoing in South Korea, sponsored by Inovio’s Korean development partner GeneOne Life Science (KSE: 011000) with full funding from the International Vaccine Institute. Inovio anticipates interim results in 2019.
DNA-Encoded Monoclonal Antibody (dMAb)
In October, Inovio received the first two U.S. patents for its DNA-encoded monoclonal antibody technology (dMAb) from the USPTO and was awarded a $2.2 million grant from the Bill & Melinda Gates Foundation to advance its dMAb platform and new clinical delivery devices. In addition, Inovio announced an important milestone in the field of dMAb immunotherapies where Inovio was the first to report evidence on the use of dMAb technology to develop novel monoclonal antibody-based therapies targeting checkpoint inhibitors.
Cash Position
As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "Utilizing ample resources, Inovio is making significant advancements on many fronts. The Phase 3 REVEAL 1 study for our lead VGX-3100 program is on track to fully enroll in 2019 and our three separate immuno-oncology, checkpoint combination Phase 2 trials, being executed with top partners and collaborators, MedImmune, Genentech, and Regeneron, are also advancing well. In fact, we saw a potential preview of what could come from the ongoing cancer efficacy studies in a new publication in Clinical Cancer Research which showcased the first complete responder from our Phase 1 MEDI0457 head & neck cancer trial. Also progressing well are our externally funded vaccine programs including the CEPI-funded Lassa vaccine program as well as IVI-funded MERS and GeneOne-funded Zika vaccine trials. Overall, these clinical trial advancements ensure that we will have multiple, meaningful data catalysts in the coming months."

Third Quarter 2018 Financial Results

Total revenue was $2.0 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses were $28.6 million compared to $31.8 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended September 30, 2018, $2.6 million was recorded as contra-research and development expense, which amount would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $4.6 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses would have been $31.2 million compared to $31.8 million for the same period in 2017.

Inovio’s net loss for the quarter ended September 30, 2018 was $25.0 million, or $0.27 per basic and diluted share, compared to $34.1 million, or $0.39 per basic and $0.40 per diluted share, for the quarter ended September 30, 2017.

Revenue

The increase in comparable revenue and grant agreement recognition for the third quarter of 2018 compared to 2017 was primarily due to increases from Inovio’s MedImmune collaboration and its CEPI grant of $1.5 million and $1.2 million, respectively. These increases were offset by a decrease in grant funding recognized from Inovio’s DARPA Ebola grant of $1.2 million, among other variances.

Operating Expenses

Research and development (R&D) expenses for the three months ended September 30, 2018 were $21.9 million compared to $25.5 million for the same period in 2017. The decrease in R&D expenses was primarily due to the $2.6 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.4 million in expenses related to Inovio’s DARPA Ebola grant. These decreases were slightly offset by an increase of $1.4 million for drug manufacturing related to Inovio’s collaboration with MedImmune and an increase of $746,000 related to employee headcount to support clinical trials and partnerships, among other variances.

General and administrative (G&A) expenses were $6.8 million for the three months ended September 30, 2018 versus $6.3 million for the same period in 2017.

Capital Resources

As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018. As of September 30, 2018, the Company had 94.5 million common shares outstanding and 105.1 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units and convertible preferred stock.

During the nine months ended September 30, 2018 the Company sold 2,967,480 shares of common stock under its current and prior ATM common stock sales agreements for aggregate net proceeds of $14.9 million.

During the nine months ended September 30, 2018, stock options and warrants to purchase an aggregate of 713,944 shares of common stock were exercised for aggregate net proceeds of $2.3 million.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q for the quarter ended September 30, 2018 providing the complete 2018 third quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 39603.

Omeros Corporation Reports Third Quarter 2018 Financial Results

On November 8, 2018 Omeros Corporation (NASDAQ: OMER) reported recent highlights and developments as well as financial results for the third quarter ended September 30, 2018, which include (Press release, Omeros, NOV 8, 2018, View Source;p=irol-newsArticle_Print&ID=2376325 [SID1234531046]):

3Q 2018 total and OMIDRIA revenues were $4.6 million, compared to $1.7 million in 2Q 2018 and $21.7 million in last year’s third quarter. The increase over the last quarter is primarily due to revenues from the company’s wholesalers in anticipation of renewed buying from ambulatory surgery centers (ASCs) and hospitals as a result of the reinstatement of pass-through reimbursement on October 1, 2018. The decrease from 3Q 2017 is due to the significant reduction in OMIDRIA usage by ASCs and hospitals in 3Q 2018 as a result of the absence of transitional pass-through reimbursement, which expired for OMIDRIA on January 1, 2018.
Sell-through for October 2018 was 81% of sell-through in October 2017, which was our highest month of OMIDRIA sell-through to date.
The recently released 2019 Outpatient Prospective Payment System (OPPS) final rule for the Centers for Medicare & Medicaid Services (CMS) includes provisions that are expected to provide for continued separate reimbursement for OMIDRIA after its recently reinstated pass-through status expires on October 1, 2020.
Net loss in 3Q 2018 was $39.5 million, or $0.81 per share. Non-cash expenses were $5.0 million, or $0.10 per share.
At September 30, 2018, the company had cash, cash equivalents and short-term investments available for operations of $55.2 million.
Results from the second reported cohort from Omeros’ ongoing Phase 2 clinical trial in patients with Immunoglobulin A (IgA) nephropathy are consistent with the first cohort and demonstrated significant reductions in proteinuria ranging from greater than 50% to approximately 70% following extended treatment with OMS721.
Recent meetings with multiple European national regulatory authorities resulted in uniform recommendations to submit a marketing authorization application, or MAA, for full approval of OMS721 for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Based on these meetings, Omeros has filed with the European Medicines Agency (EMA) a letter of intent to submit a marketing authorization application (MAA) via EMA’s centralized procedure for approval of OMS721 for the treatment of HSCT-TMA and expects to receive assignment of a rapporteur and co-rapporteur by year end.
The U.S. Food and Drug Administration (FDA) granted orphan drug designation to OMS721 for the treatment of HSCT-TMA, and the European Commission adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union for treatment in HSCT.
Omeros’ Phase 1 clinical trial for the company’s lead phosphodiesterase 7 (PDE7) inhibitor OMS527 is underway, and the company has completed dosing in the first six cohorts of subjects, which included a food effect study. The compound has been well tolerated, and pharmacokinetic data support once-daily dosing, with or without food.
"We are pleased with the strong demand that we are seeing for OMIDRIA so soon following reinstatement of its pass-through payment status," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We expect that ramp to continue, generating a growing revenue stream to support our advancing pipeline. Omeros’ lead product in that pipeline, our MASP-2 inhibitor OMS721, is driving toward U.S. and European commercialization in stem-cell TMA, we believe that the recent positive data in IgA nephropathy meaningfully de-risks the program’s Phase 3 pivotal trial, and the aHUS program is enrolling. Our Phase 1 trial for our PDE7 inhibitor OMS527 is progressing nicely and, to date, the drug is demonstrating a good safety profile and predictable pharmacokinetics. OMS906, our MASP-3 inhibitor, is targeted for clinical development in late 2019 followed by our orally administered MASP-2 inhibitors, which are slated to enter the clinic in 2020. Our team has done a great job managing the advancement of these assets while focusing on delivering our products to the market to meet the urgent needs of patients, and I expect that we will see equal or greater achievements in 2019."

Third Quarter and Recent Developments

Developments regarding OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% include:
Pass-through status for OMIDRIA was reinitiated on October 1, 2018 following a three-quarter hiatus. Sell-through for October 2018 has already reached 81% of sell-through achieved in October 2017, which was our highest month of OMIDRIA sell-through to date.
CMS recently released its 2019 final rule for the OPPS. In it, CMS indicated that it will separately pay in the ASC setting for non-opioid drugs used during surgery that have an FDA-approved indication for postoperative pain relief and that are packaged in calendar year 2019. Although OMIDRIA is not specifically named because it is paid separately until October 1, 2020, Omeros believes that OMIDRIA meets the definition for this non-opioid exclusion. The preamble to this section of the OPPS Final Rule indicates that CMS will apply the exclusion from packaged payment to other drugs in the future if they meet the criteria. The OPPS Final Rule also states that CMS will consider in future rulemaking a policy that pays separately for drugs used during cataract surgery that have an FDA-approved indication to address postoperative issues. Omeros believes that OMIDRIA also meets this definition.
The most recent manuscripts published or submitted for publication reporting the results of "real-world" clinical studies show that, compared to epinephrine in both conventional and femtosecond-laser assisted cataract surgery, OMIDRIA decreased the need for pupil expansion devices and shortened surgical times for cataract surgery, demonstrating how the use of OMIDRIA may increase the efficiency and reduce the costs of cataract surgery. These studies add to the growing body of published real-world clinical studies demonstrating significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases.
Developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical hemolytic uremic syndrome (aHUS), include:
The company met recently with multiple European national regulatory authorities focused on approval pathways for OMS721 for the treatment of HSCT-TMA. Feedback from the European national regulatory authorities has been uniformly positive, each recommending that Omeros submit an MAA for full approval of OMS721 in HSCT-TMA.
The company has filed with the European Medicines Agency a letter of intent to submit an MAA for OMS721 in HSCT-TMA via the centralized procedure and looks forward to receiving assignment of a rapporteur and co-rapporteur who will work with the company through the MAA submission and review process. Close interactions with the FDA and European regulatory agencies are ongoing and the company continues preparations for U.S. Biologics License Application (BLA) and European MAA submissions.
The company is preparing to begin collection of chart-review-based historical data following finalization of the data collection and analysis plan. The comparison of OMS721-treated patients to the historical control is designed to support accelerated approval in the U.S. and full approval in Europe.
In October 2018, Omeros reported positive results in patients with IgA nephropathy from the second reported cohort of the ongoing Phase 2 clinical trial. The cohort was designed to provide descriptive data on the effects of single and multiple 12-week courses of treatment with OMS721 in a small number of patients. Unlike the first cohort, patients in the second cohort were not taking steroids. Twelve patients were enrolled and data were reported for the nine evaluable patients. At the time of reporting, all patients had completed at least one 12-week course of treatment with either OMS721 or placebo and were eligible for OMS721 treatment during the dosing-extension phase of the study.
At week 18, median reduction in proteinuria was 18.4 percent in the five OMS721-treated patients and 18.0 percent in the four placebo patients.
Eight patients had at least 18 weeks of data and received at least one 12-week course of treatment with OMS721. In these patients, median reduction from baseline proteinuria was 56 percent; and five of the eight had received only one course of OMS721 treatment.
Four patients in this OMS721 dosing-extension period have reached between nine and 12 months beyond baseline, and show reductions in proteinuria of 54 percent, 57 percent, 65 percent, and 68 percent. At most recent assessment, two of these four patients continued to demonstrate sustained reductions in proteinuria for 2.5 and 5 months, respectively, after cessation of treatment with OMS721; the other two patients just recently completed treatment courses.
The company and international experts in IgA nephropathy believe that these data are strongly positive and supportive of a disease modifying effect, with the magnitude of proteinuria reduction consistent with that from the previously reported first cohort of the clinical trial.
Omeros announced in October 2018 that the FDA granted orphan drug designation to OMS721 for the treatment of HSCT-TMA and announced in July 2018 that the European Commission adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union for treatment in HSCT.
In Omeros’ phosphodiesterase 7, or PDE7, program, the company is developing proprietary compounds to treat addiction and compulsive disorders as well as movement disorders. A Phase 1 single-ascending- and multiple-ascending-dose clinical trial is underway with the company’s lead PDE7 inhibitor and is designed to assess safety and pharmacokinetics of the compound in healthy subjects. The company has completed dosing in the first six cohorts of subjects, including one cohort that assessed food effect. The compound to date has been well tolerated and pharmacokinetic data support once-daily dosing, with or without food. Completion of the Phase 1 trial is slated for the first half of 2019. Following Phase 1 completion, if successful, Omeros plans to conduct an initial OMS527 Phase 2 clinical trial in patients with nicotine addiction.
Financial Results

For the quarter ended September 30, 2018, revenues were $4.6 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $1.7 million in 2Q 2018 and $21.7 million for the third quarter of 2017. The increase over the last quarter is primarily due to revenues from the company’s wholesalers in anticipation of renewed buying from ASCs and hospitals as a result of the reinstatement of pass-through reimbursement on October 1, 2018. The decrease from 3Q 2017 is due to the significant reduction in OMIDRIA use by ASCs and hospitals in 3Q 2018 as a result of the absence of transitional pass-through reimbursement, which expired for OMIDRIA beginning January 1, 2018.

During the last week of September and for October 2018, the company saw OMIDRIA sales from the company’s wholesalers to its customers (sell-through) increase significantly compared to the first three quarters of 2018. In addition, in October 2018, the company’s ASC and hospital customers purchased approximately 17,500 units of OMIDRIA from its wholesalers. October 2017 was the single highest sell-through month for OMIDRIA and in October 2018, the first month of pass-through reinstatement for OMIDRIA, the drug achieved 81% of this record high.

Total costs and expenses for the three months ended September 30, 2018 were $40.1 million compared to $26.8 million for the same period in 2017. The increase from the prior quarter was primarily due to higher manufacturing scale-up costs including the acquisition of manufacturing materials for the OMS721 programs and to incremental costs associated with initiating the OMS721 IgA nephropathy Phase 3 clinical trial and the July 2018 initiation of the company’s Phase 1 clinical trial in OMS527. These increases were partially offset by decreased OMIDRIA patent litigation costs.

For the three months ended September 30, 2018, Omeros reported a net loss of $39.5 million, or $0.81 per share, which included non-cash expenses of $5.0 million ($0.10 per share). In comparison, for the prior year’s third quarter Omeros reported a net loss of $7.5 million, or $0.16 per share including non-cash expenses of $4.2 million ($0.09 per share).

As of September 30, 2018, the company had $55.2 million of cash, cash equivalents and short-term investments available for operations and another $5.8 million in restricted investments.

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 at 5:30 a.m. Pacific Time; 8:30 a.m. Eastern Time tomorrow, Friday, November 9, 2018. 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 7771247. 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 7771247.

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.