On November 12, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the quarter ended September 30, 2019 and provided a corporate update (Press release, Gossamer Bio, NOV 12, 2019, View Source [SID1234550974]).

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"Since the beginning of the third quarter, we have realized substantial progress advancing our diverse pipeline of four clinical-stage programs," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "Notably, this morning we were pleased to announce that we entered into a clinical trial collaboration with Merck to evaluate KEYTRUDA in combination with GB1275 in selected advanced solid tumors. We believe this combination holds great promise to address a significant unmet need, and we look forward to sharing initial data from our Phase 1/2 study in 2020."

Dr. Gujrathi concluded, "We look forward to continuing the momentum we have built during 2019 into what we expect will be an exciting 2020, with data readouts expected across all of our clinical programs."

Pipeline Updates

GB001: Oral DP2 Antagonist for Asthma and Allergic Disease

Two abstracts supporting GB001 were presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting 2019, held November 7-11 in Houston, Texas, including an analysis of Phase 2 study results previously reported by our partner, Teijin Pharma Ltd. Both posters can now be found in the Posters and Publications section of Gossamer’s website:

Phase 2 study results of DP2-antagonist GB001 on asthma worsening and other asthma control markers

Indicators of Asthma Exacerbation Before Initiation of Biologic Therapy: A Real-world Experience

A poster supporting GB001 was presented at the European Respiratory Society (ERS) International Congress 2019, held September 28 – October 2 in Madrid, Spain. This poster can also be found in the Posters and Publications section of Gossamer’s website.

Markers of Eosinophilic Inflammation are Associated with Response to the DP2 Antagonist GB001 in Patients with Mild Atopic Asthma

Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma remains on track, with an interim analysis expected in the first half of 2020 and topline results expected in the second half of 2020.

Enrollment continues in the Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, with and without nasal polyps. Topline data from the TITAN study are expected in the second half of 2020.

Gossamer plans to initiate a translational Phase 2 trial in chronic spontaneous urticaria in the first half of 2020 to further characterize the opportunity for DP2 antagonism in this indication.

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Two abstracts supporting GB002 have been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2019, being held November 16-18 in Philadelphia, Pennsylvania, both of which will be found in the Posters and Publications section of Gossamer’s website following their presentation:

In Vivo Efficacy of a Novel, Inhaled PDGFRa/b Inhibitor, GB002, In the Rat Monocrotaline and Pneumonectomy Model of Pulmonary Arterial Hypertension

GB002, A Novel Inhaled PDGFR Kinase Inhibitor, Demonstrates Efficacy in The Su5416 Hypoxia Rat Model of Pulmonary Arterial Hypertension (PAH)

Gossamer expects enrollment of its Phase 1b study of GB002 in patients with PAH to begin in the fourth quarter of 2019. Gossamer expects to release initial topline results from the study in the first half of 2020.

Gossamer plans to initiate a Phase 2 study in patients with PAH in the first half of 2020.

GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

The Phase 1b study in active mild-to-moderate ulcerative colitis remains on track for initial topline results in the first half of 2020.

GB1275: Oral CD11b Modulator for Oncology Indications

Gossamer reported that it has entered into a clinical trial collaboration with Merck to evaluate GB1275 in combination with KEYTRUDA (pembrolizumab) in the KEYNOTE-A36 Phase 1/2 trial. Enrollment in the trial is now underway, with initial data expected in the second half of 2020.

During the third quarter, the U.S. Food and Drug Administration granted orphan drug designation to GB1275 for the treatment of pancreatic cancer.

The design and rationale for the Phase 1/2 first-in-human trial of GB1275 was featured in a trial-in-progress poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, held November 6-10 in National Harbor, Maryland. This poster can now be found in the Posters and Publications section of Gossamer’s website.

A phase 1/2 study of GB1275, a novel CD11b modulator, as monotherapy and with an anti-PD-1 antibody in specified advanced solid tumors or with chemotherapy in metastatic pancreatic cancer (mPDAC)

Financial Results for Quarter Ended September 30, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2019, were $446.5 million. The Company expects

current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the fourth quarter of 2021.

Research and Development (R&D) Expenses: For the quarter ended September 30, 2019, R&D expenses were $40.1 million, including $2.7 million of stock-based compensation, compared to R&D expenses of $18.9 million for the quarter ended September 30, 2018. The increase was primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275.

In-Process Research and Development (IPR&D) Expenses: For the quarter ended September 30, 2019, IPR&D expenses were $0.0 million, compared to $8.3 million for the quarter ended September 30, 2018, which included $7.5 million associated with the acquisition of GB1275.

General and Administrative (G&A) Expenses: For the quarter ended September 30, 2019, G&A expenses were $9.8 million, which included $3.0 million of stock-based compensation. This compared to G&A expenses of $22.9 million for the quarter ended September 30, 2018, which included $18.0 million of stock-based compensation.

Net Loss: For the quarter ended September 30, 2019, net loss was $48.5 million, or a loss of $0.80 per share.

Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, November 12, to discuss its third quarter 2019 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 1981058

Domestic Dial-in Number: (866) 221-1654

International Dial-in Number: (470) 495-9466

Live Webcast: View Source

On November 12, 2019 NGM Biopharmaceuticals, Inc. (NGM or the Company) (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported business highlights and third quarter 2019 financial results for the period ending September 30, 2019 (Press release, NGM Biopharmaceuticals, NOV 12, 2019, View Source [SID1234550973]).

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"We continue to build momentum across our three therapeutic focus areas: metabolic disease, oncology and ophthalmic disease," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "We’re very encouraged by the interim results we reported last month from the 24-week cohort in our aldafermin Phase 2 study. Consistent with our prior Phase 2 readouts, these data reinforce that aldafermin rapidly returns patients to near normal levels of liver fat and other key inflammatory and fibrotic biomarker measures by 12 weeks, and that these clinically meaningful reductions are sustained through a 24-week period. We look forward to learning early next year whether extending the duration of improved liver health from 12 to 24 weeks will translate to histological benefit. With our ongoing Phase 2b ALPINE 2/3 study of aldafermin, we are working to build a strong clinical case for the efficacy and tolerability of aldafermin in treating NASH patients."

Dr. Woodhouse continued, "We are also advancing a Phase 1 study of NGM621 in patients with dry AMD and are preparing to initiate a Phase 1a/1b study of NGM120 in patients with solid tumors, some of whom are afflicted with cancer anorexia-cachexia syndrome (CACS). Like NASH, dry AMD and CACS are diseases characterized by large unmet medical needs. We are working diligently to develop transformative medicines for those patients. These programs are part of our strategic collaboration with Merck, which has enabled us to broaden our pipeline into areas such as oncology and ophthalmology. We are also advancing another wholly-owned program, NGM395, a long-acting GDF15 receptor agonist, into a Phase 1 safety and tolerability study."

Third Quarter 2019 and Recent Highlights

Reported preliminary topline results from interim analysis of Cohort 4 in the Phase 2 clinical study of aldafermin (NGM282) in NASH patients with Stage 2 or 3 (F2-F3) fibrosis. The protocol for this cohort, which includes 78 patients with biopsy-confirmed NASH and F2-F3 liver fibrosis, consists of an assessment of the efficacy, safety and tolerability of a 1 mg daily dose of aldafermin compared to placebo over 24 weeks. A pre-specified interim analysis conducted in approximately half the patients revealed that 24 weeks of treatment with aldafermin was well-tolerated and resulted in statistically significant reductions compared to placebo in absolute and relative liver fat, alanine aminotransferase (ALT) and PRO-C3. See link here to view a summary of the Cohort 4 interim analysis findings.

Topline results of the full Cohort 4, which will include an assessment of the effect of 24 weeks of treatment on liver histology, are anticipated in the first quarter of 2020. NGM plans to report preliminary results on ALPINE 2/3, an ongoing Phase 2b study of aldafermin in NASH patients with F2-F3 fibrosis, by the end of 2020.

Disclosed complement C3 as the target for NGM621, an antibody intended to slow progression of vision loss in patients with dry AMD. NGM621 is an inhibitory antibody binding complement C3, a key node of all three complement pathways. Human genetics data suggest that inhibition of complement can effectively slow the progression of AMD. A Phase 1 study is currently underway to evaluate the safety, tolerability and pharmacokinetics of up to two intravitreal doses of NGM621 in patients with geographic atrophy, the dry form of advanced AMD. Currently, there are no approved therapies to treat geographic atrophy, a disease that is prevalent in approximately one million adults in the United States and progresses to permanent loss of central vision.

Announced addition of Valerie Pierce as Senior Vice President, General Counsel and Chief Compliance Officer. NGM continued to expand its leadership team with the addition of Ms. Pierce to provide legal oversight to the Company. Prior to joining NGM in September 2019, Ms. Pierce served as Senior Vice President, Associate General Counsel at Jazz Pharmaceuticals, Inc. (Jazz). She brings to NGM over 25 years of experience providing legal counsel to public pharmaceutical and biotechnology companies, including Jazz, Amyris, Inc., Sunesis Pharmaceuticals, Inc., Tularik Inc. (acquired by Amgen, Inc.) and ALZA Corporation (acquired by Johnson & Johnson). Ms. Pierce received a B.A. from Yale University and a J.D. from the Yale Law School.

Third Quarter Financial Results

Related party revenue for the third quarter of 2019 was $21.6 million, compared to $20.8 million for the same period in 2018.

Research and development expenses for the third quarter of 2019 were $29.0 million, compared to $24.5 million for the same period in 2018. The increase in research and development expenses was primarily attributable to increases in unallocated research and development expenses associated with personnel-related expenses, external research and development expenses associated with the advancement of NGM’s growing pipeline and aldafermin program expenses for ongoing Phase 2 and Phase 2b clinical trials.

General and administrative expenses for the third quarter of 2019 were $5.6 million, compared to $4.8 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and other professional service expenses required to support NGM’s operations as a public company.

For the third quarter of 2019, NGM reported a net loss of $10.9 million, compared to a net loss of $7.5 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities were $356.6 million as of September 30, 2019, compared to $206.6 million as of December 31, 2018. The increase of $150.0 million was primarily attributable to net cash proceeds of $173.7 million from the Company’s initial public offering and concurrent private placement, offset by cash used in operations over the period.

On November 12, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the quarter ended September 30, 2019 (Press release, Sunesis, NOV 12, 2019, View Source [SID1234550972]). Loss from operations for the three and nine months ended September 30, 2019 was $6.0 million and $17.9 million. As of September 30, 2019, the Company had cash and cash equivalents, restricted cash and marketable securities of $38.3 million.

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"We continue to advance our Phase 1b/2 trial of vecabrutinib in patients with B-cell malignancies with the goal of identifying our recommended dose and studying vecabrutinib in defined patient populations in the Phase 2 portion of the study. We are currently in the 400mg cohort as the safety and pharmacokinetic data to date support continued dose escalation," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "As announced last week, we will be presenting a poster at the ASH (Free ASH Whitepaper) Annual Meeting in December that provides an update on the Phase 1b/2 trial of vecabrutinib, and we look forward to sharing the new findings. We also recently presented exciting preclinical pharmacology data for our first-in-class PDK1 inhibitor, SNS-510, at the AACR (Free AACR Whitepaper)-NCI-EORTC conference. The equity offering we completed in July strengthened our cash position and extends our runway through key milestones for the Company."

Recent Highlights

Announced Presentation at ASH (Free ASH Whitepaper) Annual Meeting. In November 2019, the Company announced that a presentation will be made at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 7-10, 2019 in Orlando, Florida. The abstract, titled "Ongoing Results of a Phase 1B/2 Dose-Escalation and Cohort-Expansion Study of the Selective, Noncovalent, Reversible Burton’s Tyrosine Kinase Inhibitor, Vecabrutinib, in B-Cell Malignancies" (Publication 3041), will be presented on Sunday, December 8, in a session titled "CLL: Therapy, excluding Transplantation: Poster II," from 6:00-8:00pm ET at the Orange County Convention Center, Hall B. The poster will be available on the Sunesis website following the presentation.

Presented Preclinical Data on SNS-510 at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In October 2019,

Sunesis presented data profiling the oral PDK1 inhibitor SNS-510 showing potent activity in hematologic and solid tumor cancer models at the 2019 AACR (Free AACR Whitepaper)-NCI-EOTRC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts.

Hired Mehdi Paborji, PhD as VP Technical Operations; promoted Pietro Taverna, PhD to VP Translational Medicine & Nonclinical Development. Dr. Paborji has over 30 years of experience in the industry, including fifteen years at Bristol-Myers Squibb. More recently he served as Chief Operating Officer of Biotie Therapeutics through its sale to Acorda Therapeutics and was also the Founder and COO of Theravida. He has experience leading technical and clinical supply operations, and all aspects of manufacturing of drug substance and drug product. Dr. Paborji has a PhD. in Physical Organic and Bio-Organic Chemistry from the University of Kansas and postdoctoral training in Pharmaceutical Chemistry from the University of Kansas, the School of Pharmacy. Dr. Taverna has over 18 years of experience in the biopharmaceutical industry, exclusively in oncology pharmacology and translational medicine. He returned to Sunesis in 2017 as head of Translational Medicine after nine years at Astex (Otsuka) Pharmaceuticals leading translational medicine programs for their oncology portfolio. Prior to Astex, Dr. Taverna held senior/principal scientist positions at Sunesis and Chiron, overseeing and conducting pharmacology efforts for cancer drug candidates. He has numerous publications as well as presentations at international oncology meetings. Dr. Taverna has a Ph.D. in Pharmacological Research from M. Negri Institute for Pharmacological Research, Milano, Italy and did postdoctoral research at the Institute and at Case Western University.

Appointed Dr. Nicole Onetto to the Board of Directors. In September 2019, Sunesis appointed Dr. Nicole Onetto, M.D. to the Board of Directors, bringing to Sunesis 20 years of clinical development experience in oncology and hematology.

Completion of Public Offering. In July 2019, Sunesis completed underwritten public offerings of shares of its common stock and Series F convertible preferred stock with net proceeds of approximately $26.1 million. The offerings attracted participation from leading biotechnology investors, including existing and new investors.

Financial Highlights

Cash and cash equivalents, restricted cash, and marketable securities totaled $38.3 million as of September 30, 2019, compared to $13.7 million as of December 31, 2018. The increase of $24.6 million was primarily due to $45.1 million in net proceeds from issuance common and preferred stock, and $5.5 million in proceeds from the Silicon Valley Bank Loan Agreement, partially offset by $18.4 million in net cash used in operating activities and $7.5 million principal payment on the Bridge Bank / Solar Capital Loan Agreement and Amendments. This capital is expected to fund the Company through the identification of the Phase 2 dose and initiation of the Phase 2 portion of the ongoing trial.

Research and development expense was $3.5 million and $10.5 million for the three and nine months ended September 30, 2019, compared to $3.6 million and $11.3 million for the same periods in 2018. The decreases between the comparable three and nine month periods were primarily due to a decrease in salary and personnel expenses due to lower headcount and a decrease in clinical expense due to timing, offset by an increase in professional services related to the preparation for the Phase 2 portion of the ongoing clinical trial for vecabrutinib.

General and administrative expense was $2.5 million and $7.5 million for the three and nine months ended September 30, 2019, compared to $2.7 million and $8.9 million for the same periods in 2018. The decreases between the comparable periods were primarily due to a decrease in salary and personnel expenses due to lower headcount and stock-based compensation and a decrease in professional services expenses due to lower legal and vosaroxin patent expenses, offset by an increase in insurance premiums.

Interest expense was $0.1 million and $0.4 million for the three and nine months ended September 30, 2019, compared to $0.3 million and $0.9 million for the same periods in 2018. The decreases in interest expenses from both periods resulted from the lower interest rate paid on a lower principal amount under the SVB Loan Agreement.

Cash used in operating activities was $18.4 million for the nine months ended September 30, 2019, compared to $17.9 million for the same period in 2018. Net cash used in the nine months ended September 30, 2019 resulted primarily from the net loss of $18.0 million and changes in operating assets and liabilities of $1.8 million, offset by adjustments for non-cash items of $1.4 million. Net cash used in 2018 period resulted primarily from the net loss of $20.6 million, partially offset by adjustments for non-cash items of $2.3 million and changes in operating assets and liabilities of $0.4 million.

Sunesis reported loss from operations of $6.0 million and $17.9 million for the three and nine months ended September 30, 2019, compared to $6.3 million and $20.0 million for the same periods in 2018. Net loss was $5.9 million and $18.0 million for the three and nine months ended September 30, 2019, compared to $6.5 million and $20.6 million for the same periods in 2018.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (International) and entering passcode 4059849. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On November 12, 2019 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a proposed public offering of up to 5,000,000 shares of its common stock (Press release, Replimune, NOV 12, 2019, View Source [SID1234550971]). All shares in the offering will be offered by Replimune . In addition, Replimune intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock from Replimune on the same terms and conditions.

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J.P. Morgan Securities LLC, SVB Leerink LLC, and BMO Capital Markets Corp. are acting as book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and Replimune cannot assure you as to whether or when the offering may be completed.

This proposed offering will be made only by means of a preliminary prospectus supplement and the accompanying prospectus. A copy of the preliminary prospectus supplement relating to this offering will be filed with the Securities and Exchange Commission (the "SEC") and may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

The shares of common stock described above are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the SEC on August 8, 2019 and declared effective by the SEC on August 15, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 12, 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 third quarter ended September 30, 2019 (Press release, Omeros, NOV 12, 2019, View Source [SID1234550970]).

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Third Quarter 2019 Financial Highlights

3Q 2019 revenues were $29.9 million, another quarter of record sales of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. This compares to $26.8 million in 2Q 2019, an increase of $3.1 million, or 12 percent.

Net loss in 3Q 2019 was $16.5 million, or $0.33 per share. This compares to a net loss $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in each period included non-cash expenses of $6.3 million, or $0.13 per share.

At September 30, 2019, Omeros had cash, cash equivalents and short-term investments available for operations of $27.3 million, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019 there were no borrowings outstanding.

Recent Business Highlights

Submitted to the U.S. Food and Drug Administration (FDA) the nonclinical sections of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Received from the Pediatric Committee of the European Medicines Agency (EMA) a positive opinion on the pediatric investigation plan for narsoplimab in the treatment of HSCT-TMA.

Reported positive results from a Phase 1 study of the lead compound in Omeros’ OMS527 program focused on development of phosphodiesterase 7 (PDE7) inhibitors for the treatment of addiction and compulsive disorders. In the double blind, randomized Phase 1 study, the study drug, referred to as OMS182399, met the primary endpoints of safety and tolerability and showed a favorable pharmacokinetic profile supporting once-daily dosing.

Presented data on a series of discoveries showing that GPR174, a member of the family of G protein-coupled receptors (GPCRs), controls a new axis in cancer immunity. In addition to demonstrating the potential of GPR174 as a standalone anti-cancer agent, these data show that the combined inhibition of both GPR174 and the adenosine pathway synergistically enhances T-cell response. This synergistically enhanced T-cell response could significantly improve the effectiveness of checkpoint inhibitors and other anti-cancer drugs.

Scientists from Omeros along with academic collaborators from the University of Toronto were awarded the Prix Galien Canada Research Award for 2019 in recognition of their development of the drug discovery technologies underlying Omeros’ GPCR platform. The Prix Galien is the most prestigious award in the field of Canadian pharmaceutical research and innovation and recognizes the research team judged to have made the most significant contribution.

"Initiating submission of our rolling BLA for narsoplimab in stem cell transplant-associated TMA is a significant milestone on our path to becoming a multi-product commercial biopharmaceutical company and, more importantly, is a major advance in our mission to treat these patients," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We are on track to complete submission of our BLA in the first half of 2020 and preparations for the anticipated commercial launch of narsoplimab are also progressing. We continue to grow utilization of OMIDRIA, delivering record quarterly sales in Q3 and projecting a new all-time high in the fourth quarter. The remainder of our pipeline assets are also progressing – OMS527 has successfully completed its Phase 1 trial in our addiction program, our MASP-3 inhibitor OMS906 is on track to enter the clinic in the first half of next year, and our GPR174 immuno-oncology program continues to generate exciting new in vivo data, which will be presented for the first time later this month at the AACR (Free AACR Whitepaper) conference in Boston."

Other Business Updates and Developments

Recent developments regarding OMIDRIA include the following:

The new product-specific permanent J-code for OMIDRIA became 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 has been broadly uploaded to Medicare and commercial payer systems nationwide and is expected to expand reimbursement to commercial, Medicare Advantage and Medicaid insurers that would not reimburse for OMIDRIA under the prior C-code and to enable access to the increasing number of cataract procedures performed in the physician office setting.

In October, a manuscript authored by Keith Walter, M.D. of Wake Forest University, was accepted for publication in the peer-reviewed Journal of Cataract and Refractive Surgery. Dr. Walter’s study consisted of a retrospective analysis of 504 eyes (357 patients) on whom he had performed cataract surgery using OMIDRIA plus only a topical non-steroidal anti-inflammatory drug (NSAID), assessing the incidence of CME. The control group consisted of a collection of single and meta-analytic studies published in the peer-reviewed literature in which steroids, with and without topical NSAIDs, were used in cataract surgery in the absence of OMIDRIA. Of the 504 eyes treated with OMIDRIA, only two developed postoperative CME, an incidence of 0.39 percent, which is 3- to 12-fold lower than the CME rates in the published peer-reviewed studies.

On November 1, 2019, the Centers for Medicare and Medicaid Services (CMS) issued the 2020 final rule for its outpatient prospective payment system (OPPS). CMS had described criteria that must be met in order for products to be eligible for separate payment under legislation requiring CMS to review its OPPS payments with a goal of ensuring that there are not financial incentives to use opioids for pain management instead of non-opioid alternatives. Although Omeros submitted to CMS data for OMIDRIA that meet the criteria, CMS declined in its 2020 final rule to grant separate payment for OMIDRIA beyond the expiration of its current pass through status on September 30, 2020. CMS indicated it would continue to analyze evidence and monitor utilization of OMIDRIA and Omeros intends to continue its administrative and legislative efforts to secure ongoing separate payment for OMIDRIA.

On November 4, 2019 the results of an independent investigator study of the effect of OMIDRIA use on the utilization of fentanyl, an opioid, in cataract surgery were published in the peer-reviewed journal Clinical Ophthalmology. The article, The Effect of Phenylephrine/Ketorolac Intracameral Solution 1%/0.3% on Pain and Opioid Use During Cataract Surgery, is authored by the study investigator Eric D. Donnenfeld, M.D., Clinical Professor of Ophthalmology at New York University and recent past president of the American Society of Cataract and Refractive Surgery. The prospective, controlled study showed that use of OMIDRIA in cataract surgery had a direct, clinically meaningful and statistically significant effect on reduction in fentanyl use (77% reduction, p = 0.006) while reducing visual analog scale (VAS) pain scores by approximately 50 percent (p < 0.0001).

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:

In October, Omeros submitted to FDA the nonclinical (i.e., pharmacology, pharmacokinetics and toxicology) data, study reports, overview and summary sections of its rolling BLA for narsoplimab to treat HSCT-TMA. Once all clinical data collection, dataset compilation and data analyses are complete, the clinical sections of the BLA

will be submitted, followed by the quality (i.e., chemistry, manufacturing and controls) sections. Submission of the clinical and quality sections remains on track for scheduled completion in the first half of next year.

The Pediatric Committee of the EMA issued a positive opinion for Omeros’ pediatric investigation plan (PIP) for narsoplimab in the treatment of HSCT-TMA. Agreement with the pediatric committee on a PIP outlining a development program for the investigational product in the pediatric population is a prerequisite to EMA’s acceptance of a Marketing Authorization Application (MAA) for the product. Omeros received a deferral for completion of its pediatric plan until after EMA approval of the MAA planned for submission to EMA for narsoplimab in the treatment of HSCT-TMA. With successful completion of the PIP, narsoplimab would be eligible for up to an additional two years of marketing exclusivity.

Omeros’ Phase 3 trial evaluating narsoplimab for IgA nephropathy, referred to as ARTEMIS-IGAN, continues enrollment at an increasing number of sites in the U.S. and internationally.

A manuscript prepared by Omeros’ Academic Leadership Committee detailing the clinical data from the Phase 2 IgA nephropathy program is expected to be published in a peer-reviewed journal. In addition, a report detailing the response to narsoplimab treatment by a patient with IgA vasculitis-associated nephritis and rapidly progressive glomerulonephritis has been submitted for publication.

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

IND-enabling toxicology studies have begun for OMS906, Omeros’ MASP-3 inhibitor, in advance of clinical entry slated for the first half of next year. Targeting subcutaneous dosing of twice-monthly or less frequently, this program is initially targeting paroxysmal nocturnal hemoglobinuria.

Omeros continues life-cycle management within its MASP-2 program. These efforts are directed to development of a longer-acting second-generation antibody against MASP-2 as well as an orally available small-molecule inhibitor of MASP-2, both targeted for clinical entry in 2021.

A presentation entitled "Phosphatidylserine suppresses T cells through GPR174, and co-inhibition of adenosine receptors and GPR174 synergistically enhances T cell responses" will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference on Tumor Immunology and Immunotherapy to be held in Boston, November 17-20, 2019. It will include additional animal data that validate GPR174 inhibition for cancer immunotherapy. The company’s GPR174 program has also been selected for participation in the 2019 Immuno-Oncology Congress of the European Society for Medical Oncology to be held in Geneva, December 11-14, 2019.

Financial Results

3Q 2019 revenues, all related to sales of OMIDRIA, were $29.9 million, a new record high. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $3.1 million, or 12 percent, from the $26.8 million achieved in 2Q 2019. The increase is due to a growing number of purchasing accounts as well as deeper penetration within accounts across hospitals, ASCs, Veterans Administration and other government payers.

Gross-to-net deductions in 3Q 2019 remained consistent with those in 2Q 2019 at 28 percent

3Q 2019 costs and expenses were $41.0 million compared to $36.1 million for Q2 2019. The increase reflected incremental narsoplimab manufacturing costs associated with the commencement of full-scale drug substance manufacturing in 3Q 2019 together with increased manufacturing scale-up costs in our OMS906 program in advance of planned clinical entry next year. Selling, general and administrative expenses were $16.9 million for both 2Q and 3Q 2019.

For 3Q 2019, Omeros reported a net loss of $16.5 million, or $0.33 per share, compared to a net loss of $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in both 2Q 2019 and 3Q 2019 included non-cash expenses of $6.3 million ($0.13 per share).

As of September 30, 2019, Omeros had $27.3 million of cash, cash equivalents and short-term investments available for operations, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019, there were no borrowings outstanding.

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 9699377. 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 9699377.

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.