On November 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2018 (Press release, Coherus Biosciences, NOV 8, 2018, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" rel="nofollow">View Source [SID1234531695]).

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Third Quarter 2018 and Recent Corporate Highlights Include:

On September 25, 2018, the European Commission (EC) approved UDENYCA by granting marketing authorization in all European Union member states.
On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. UDENYCA is Coherus’ first drug to receive FDA or EC approval.
In preparation for a comprehensive launch of UDENYCA, Coherus completed the hiring of about 70 sales representatives covering seven territories as well as the hiring of other personnel for our commercial groups and teams.
Third Quarter 2018 Financial Results:
Research and development (R&D) expenses for the third quarter of 2018 were $31.6 million compared to $42.6 million for the same period in 2017. R&D expenses for the nine months ended September 30, 2018 were $83.6 million, as compared to $130.9 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar). These cost decreases were partially offset by the costs associated with the manufacturing of UDENYCA.
General and administrative (G&A) expenses for the third quarter of 2018 were $25.4 million, compared to $14.0 million for the same period in 2017. G&A expenses for the nine months ended September 30, 2018 were $60.3 million, as compared to $56.3 million for the same period in 2017. The increases in G&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial infrastructure to launch and sell UDENYCA in the U.S.
Net loss attributable to Coherus for the third quarter of 2018 was ($58.8) million, or ($0.87) per share, compared to a net loss of ($59.0) million, or ($1.09) per share, for the same period in 2017.
Cash and cash equivalents and investments in marketable securities – totaled $117.2 million as of September 30, 2018, compared to $159.8 million as of June 30, 2018. Cash use in operations of $42.8 million during the third quarter of 2018 was lower than guidance of $48 to $53 million.

Guidance for next twelve months from September 30, 2018:
UDENYCA (pegfilgrastim-cbqv), Neulasta biosimilar

Anticipate U.S. commercial launch in January 2019.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S. at the end of 2019.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer and continue clinical development of CHS-3351.
Continue preclinical development of CHS-2020.
CHS-131 (small molecule drug candidate in nonalcoholic steatohepatitis "NASH")

Anticipate initiation of Phase 2 clinical trial in NASH.
Conference Call Information

When: Thursday, November 8, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 7181479

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On November 7, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that the first patient has been treated in KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck’s KEYTRUDA (pembrolizumab) (Press release, OncoSec Medical, NOV 7, 2018, View Source [SID1234530901]).

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KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.

"Treating the first patient in our KEYNOTE-890 clinical trial is an important milestone for OncoSec as we seek to rapidly advance this program," said Kellie Malloy Foerter, Chief Clinical Development Officer of OncoSec. "Additionally, this study is important for patients with metastatic triple negative breast cancer given the lack of treatment options currently available. Prior clinical observations suggest that TAVO in combination with pembrolizumab is a valid therapeutic approach for TNBC. Based on the outcome of the study and feedback from FDA, we may choose to expand the study and seek accelerated approval with the FDA for this patient population."

Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of U.S. breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women, as well as African-American women,2 followed by Hispanic women.3

TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17

On November 7, 2018 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2018 and highlighted recent corporate progress (Press release, Heron Therapeutics, NOV 7, 2018, View Source [SID1234530918]).

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Recent Corporate Progress

Pain Management Franchise

Submitted NDA for HTX-011. On October 31, 2018, the Company announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.
CINV Franchise

CINV Sales. Chemotherapy-induced nausea and vomiting (CINV) franchise net product sales for the three and nine months ended September 30, 2018 were $19.8 million and $48.6 million, respectively, compared to $8.6 million and $20.7 million for the same periods in 2017, respectively. Heron has increased full-year 2018 CINV franchise net product sales guidance to $70 million to $72 million.
CINVANTI Sales. Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended September 30, 2018 were $16.4 million. This compares to $11.2 million for the three months ended June 30, 2018 and $5.2 million for the three months ended March 31, 2018. CINVANTI was approved by the FDA on November 9, 2017 and became commercially available in the U.S. on January 4, 2018. Net product sales for CINVANTI were $32.8 million for the nine months ended September 30, 2018.
SUSTOL Sales. Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2018 were $3.4 million and $15.8 million, respectively. The entry of generic palonosetron in the first quarter of 2018 has had, and is expected to have, a several-quarter negative impact on provider demand for SUSTOL.

Permanent J-Code Assigned for CINVANTI. On November 5, 2018, a product-specific billing code, or permanent J-code, for CINVANTI was assigned with an effective date of January 1, 2019. The new J-code was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of CINVANTI.
"We are pleased with the advances made during the third quarter of 2018 in both our pain management and CINV franchises, highlighted by our recent NDA submission for HTX-011 and the increase in our full-year 2018 CINV franchise net product sales guidance," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We look forward to preparing to launch HTX-011 in the U.S. for postoperative pain management, if approved, in 2019 and achieving our increased full-year 2018 CINV franchise net product sales guidance of $70 million to $72 million."

Financial Results

Net product sales for the three and nine months ended September 30, 2018 were $19.8 million and $48.6 million, respectively, compared to $8.6 million and $20.7 million for the same periods in 2017, respectively.

Heron’s net loss for the three and nine months ended September 30, 2018 was $38.3 million and $129.3 million, or $0.49 per share and $1.81 per share, respectively, compared to $41.9 million and $135.0 million, or $0.77 per share and $2.55 per share, for the same periods in 2017, respectively. Net loss for the three and nine months ended September 30, 2018 included non-cash, stock-based compensation expense of $8.1 million and $23.6 million, respectively, compared to $7.5 million and $23.6 million, for the same periods in 2017, respectively.

As of September 30, 2018, Heron had cash, cash equivalents and short-term investments of $364.8 million, compared to $172.4 million as of December 31, 2017. Net cash used for operating activities for the three and nine months ended September 30, 2018 was $35.9 million and $158.3 million, respectively, compared to $40.5 million and $123.2 million for the same periods in 2017, respectively.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron recently submitted an NDA to the FDA for HTX-011.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist. CINVANTI is the first intravenous (IV) formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain. FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

On November 7, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the first patient was dosed in a global Phase 3 clinical trial of its investigational BTK inhibitor zanubrutinib compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375817 [SID1234531033]).

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"We continue to be encouraged by data on zanubrutinib in various B-cell malignancies and are excited to further expand the development program for zanubrutinib in CLL and SLL with this Phase 3 trial, which represents the second Phase 3 study directly comparing zanubrutinib to ibrutinib," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The global Phase 3 open-label trial is expected to enroll approximately 400 patients with relapsed/refractory CLL or SLL across approximately 150 study centers in the U.S., China, Europe, Australia and New Zealand. Patients will be randomized in a one-to-one manner to either zanubrutinib (160 mg orally twice daily) or ibrutinib (420 mg orally once daily). The primary endpoint is overall response rate, as determined by independent central review. Key secondary endpoints include progression-free survival, duration of response, overall survival, patient-reported outcomes, and safety.

Zanubrutinib was recently granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). New drug applications (NDAs) in China for zanubrutinib as a treatment for patients with mantle cell lymphoma (MCL) and for patients with relapsed/refractory CLL or SLL, have been accepted for review by the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA).

Zanubrutinib is being studied in a broad registration program. In addition to this newly initiated Phase 3 trial, it is also being evaluated in a fully enrolled, global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, a global Phase 3 clinical trial in patients with previously untreated CLL, and a pivotal Phase 2 trial in combination with GAZYVA (obinutuzumab) in patients with relapsed/refractory follicular lymphoma. In China, in addition to the MCL and CLL filings, BeiGene has completed enrollment in another pivotal Phase 2 clinical trial of zanubrutinib in patients with WM.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the location where the cancer primarily occurs.1 When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.2

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

On November 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Jefferies 2018 London Healthcare Conference at 11:20 a.m. GMT (6:20 a.m. ET) on Wednesday, Nov. 14, 2018, in London (Press release, Neurocrine Biosciences, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375955 [SID1234531198]). Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month