On November 9, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, NOV 9, 2018, View Source [SID1234530992]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are pleased by the progress made in the third quarter of 2018, most notably the completion of full enrollment in the current cohorts of the UNITY-NHL trial, as well as in the ULTIMATE Phase 3 program in MS. We now have five Phase 3 or registration directed trials fully enrolled across our three major indications of interest, CLL, NHL and MS, and look forward to significant value creating data releases in 2019 and 2020." Mr. Weiss, continued, "This is just the beginning for TG as we solidify the foundation and look towards the future of building proprietary triple combination therapies with our in-house early stage pipeline."

Recent Developments and Highlights

●ASH Presentations: Announced two triple therapy data abstracts were accepted for presentation at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
●ULTIMATE Trials: Completed full enrollment into the ULTIMATE I & II Phase 3 trials, evaluating ublituximab in relapsing form of MS, which are being conducted under Special Protocol Assessment (SPA) agreement with the FDA.
●Ublituximab Data in Multiple Sclerosis: Presented final data from the Phase 2 trial of ublituximab in RMS at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting in Berlin, Germany.
●UNITY-NHL: Completed enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.

Financial Results for the Third Quarter 2018

●Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $97.8 million as of September 30, 2018.

●R&D Expenses: Research and development (R&D) expenses were $33.4 million and $107.1 million for the three and nine months ended September 30, 2018, respectively, compared to $27.1 million and $76.5 million for the three and nine months ended September 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $4.4 million and $20.1 million, respectively, during the three and nine months ended September 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and nine months ended September 30, 2018 are $5.0 million and $16.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the nine months ended September 30, 2018 was $4.0 million of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.

●G&A Expenses: General and administrative (G&A) expenses were $1.0 million and $13.2 million for the three and nine months ended September 30, 2018, respectively, as compared to $4.5 million and $11.3 million for the three and nine months ended September 30, 2017. The decrease in G&A expenses for the three months ended September 30, 2018 relates to a decrease in non-cash compensation expense related to equity incentive expense recognized during the three months ended September 30, 2018 as a result of a decrease in the measurement date fair value of certain consultant restricted stock.

●Net Loss: Net loss was $34.0 million and $119.6 million for the three and nine months ended September 30, 2018, respectively, compared to a net loss of $31.5 million and $87.6 million for the three and nine months ended September 30, 2017, respectively. Excluding non-cash items, the net loss for the three and nine months ended September 30, 2018 was approximately $34.1 million and $104.2 million.

●Financial Guidance: Net cash utilized for operating activities during the nine months ended 2018 was approximately $95.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018 will be sufficient to fund the Company’s planned operations through the end of 2019.

Conference Call Information

The Company will host an investor conference call today, November 9, 2018, at 8:30am ET, to discuss the Company’s third quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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On November 8, 2018 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported it will present two posters highlighting preclinical data and the Phase Ib clinical trial design for ADCT-301 (camidanlumab tesirine) in advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, ADC Therapeutics, NOV 8, 2018, View Source [SID1234596074]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "ADCT-301 is already being evaluated in relapsed and refractory Hodgkin lymphoma, and at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting we will be updating our abstract data from June, at which time we had an overall response rate of 80.8 percent with a complete response rate of 50 percent in median 6th line patients. Based on the immune-oncology potential ADCT-301 demonstrated in preclinical studies, we are excited to be starting a clinical trial for ADCT-301 in solid tumors to see if we can make an impact and improve patient outcomes in multiple solid tumor cancers."

Patrick van Berkel, PhD, Senior Vice President of Research and Development at ADC Therapeutics, said, "ADCT-301 targets CD25, which is expressed on Tregs that infiltrate the local tumor environment. In preclinical models, a single dose of the CD25-targeted ADC induced strong and durable anti-tumor activity against established CD25 negative solid tumors with infiltrating Tregs. Moreover, re-challenged mice did not develop new tumors indicating the CD25-targeted ADC was able to induce tumor-specific protective immunity."

ADC Therapeutics’ posters will be located in Poster Hall E in the Walter E. Washington Convention Center. The Poster Hall will be open Friday, November 9 from 8 a.m. to 8 p.m. and Saturday, November 10 from 8 a.m. to 8:30 p.m. EST. Details of the posters are below.

Abstract Poster Number: P11
Title: A CD25 targeted pyrrolobenzodiazepine dimer-based antibody-drug conjugate shows potent anti-tumor activity in pre-clinical models of solid tumors either alone or in combination with a PD-1 inhibitor
Presentation Date and Time: Friday, November 9, 12:45-2:15 p.m. and 6:30-8 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

Abstract Poster Number: P316
Title: Phase 1b dose-escalation and dose-expansion study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-301 (camidanlumab tesirine) in patients with advanced solid tumors
Presentation Date and Time: Saturday, November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST
Presenter: Francesca Zammarchi, PhD, ADC Therapeutics

For more information about the SITC (Free SITC Whitepaper) 2018 Annual Meeting, please visit View Source

About ADCT-301

ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expresing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in a Phase Ib clinical trial in solid tumors (NCT03621982), as well as ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235).

On November 8, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical-stage immunotherapy biotech company, reported the closing of a debt financing for up to $150 million (Press release, Sorrento Therapeutics, NOV 8, 2018, View Source [SID1234532262]). The financing is being provided by funds and accounts managed by Oaktree Capital Management, L.P. ("Oaktree"), a leading global investment firm. An affiliate of Oaktree is the sole administrative agent and collateral agent for the financing and Morgan Stanley & Co. LLC served as the sole placement agent for the transaction.

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"With this financing, we believe we now have adequate funding for up to the next two years, enabling us to bring several of our key clinical programs in the CAR-T and non-opioid pain management space to FDA approvals and potential commercialization," said Henry Ji, Ph.D., Chairman, President and Chief Executive Officer. "Additionally, with encouraging data readout from our ongoing Anti-CEA trial for liver metastases among pancreatic cancer patients and our recently initiated Anti-CD38 CAR-T trial for multiple myeloma cancer patients, we are optimistic about potential collaborations with strategic partners."

Building off its industry-leading fully human antibody G-MAB library, a wide array of innovative technologies such as the Sofusa lymphatics delivery system, and multi-site multi-modality cGMP facilities, Sorrento continues to expand and advance its robust clinical product pipeline.

The financing is a senior secured five-year term loan, with the first tranche of $100 million already funded and an additional tranche of $50 million available subject to Sorrento’s achievement of certain business milestones in the next nine to twelve months.

On November 8, 2018 Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics), reported that Ton Logtenberg, Ph.D., President and Chief Executive Officer of Merus, will present a company overview at the Jefferies 2018 London Healthcare Conference on Thursday, November 15, 2018, at 3:20 p.m. GMT (Press release, Merus, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376165 [SID1234532116]).

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A live webcast of the presentation will be available on the Investors and Media page of the Company’s website, View Source A replay of the presentation will be archived and available on the Merus website site for a limited time following the event.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.