Opko Health has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Opko Health, 2017, NOV 8, 2017, View Source [SID1234521781]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Anthera has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Anthera, 2017, NOV 8, 2017, View Source [SID1234521826]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On November 8, 2017 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the three and nine months ended September 30, 2017 (Press release, Lipocine, NOV 8, 2017, View Source [SID1234521742]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Third Quarter and Recent Corporate Highlights

· Resubmitted a New Drug Application ("NDA") for TLANDO, Lipocine’s oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
o The U.S. Food & Drug Administration ("FDA") acknowledged receipt of the Company’s NDA resubmission for TLANDO, and assigned a new Prescription Drug User Fee Act ("PDUFA") action goal date of February 8, 2018.
o The FDA scheduled a Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") meeting on January 10, 2018 to discuss the NDA for TLANDO.
o The NDA includes the efficacy results of a dosing validation ("DV") study, which confirmed the validity of a fixed dose approach to orally administer TLANDO without the need for dose titration, as well as an integrated safety set ("ISS") from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement ("SOAR") clinical study.

"We accomplished all of our goals for the third quarter, culminating in the resubmission and acceptance of the NDA for TLANDO by the FDA," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "TLANDO has the potential to be the first oral TRT option for patients and, if approved, will address a large and growing unmet medical need. We are preparing our presentation package for BRUDAC and look forward to discussing our NDA with the Advisory Committee in January 2018."

Third Quarter Ended September 30, 2017 Financial Results

Lipocine reported a net loss of $4.7 million, or ($0.22) per diluted share, for the third quarter ended September 30, 2017, compared with a net loss of $3.2 million, or ($0.18) per diluted share, in the third quarter ended September 30, 2016.

Research and development expenses were $2.0 million in the third quarter ended September 30, 2017, compared with $1.5 million in the third quarter ended September 30, 2016. The increase in research and development expenses was primarily due to an increase in contract research organization costs associated with the DV and Dosing Flexibility ("DF") clinical studies and an increase in contract manufacturing costs for LPCN 1107, offset by a decrease in travel and other allocated overhead costs.

General and administrative expenses were $2.7 million in the third quarter ended September 30, 2017, compared with $1.4 million in the third quarter ended September 30, 2016. The increase in was primarily due to an increase in market research and pre-commercialization activities related to TLANDO and an increase in personnel costs including accelerated vesting of stock options and restricted stock units related to a terminated employee.

As of September 30, 2017, the Company had $25.7 million of cash, cash equivalents and marketable investment securities compared to $26.8 million at December 31, 2016.

Nine Months Ended September 30, 2017 Financial Results

Lipocine reported a net loss of $15.7 million, or ($0.80) per diluted share, for the nine months ended September 30, 2017, compared with a net loss of $16.0 million, or ($0.88) per diluted share, in the nine-month period ended September 30, 2016.

Research and development expenses were $9.2 million in the nine months ended September 30, 2017, compared with $6.7 million in the nine months ended September 30, 2016. The increase in the nine months ended September 30, 2017 was primarily due to an increase in contract research organization costs related to the DV and DV clinical studies offset by a decrease in technical batch manufacturing costs for TLANDO, decreased personnel costs, decreased outside services costs and reduced travel and other allocated overhead costs.

General and administrative expenses were $6.6 million in the nine months ended September 30, 2017, compared with $9.0 million in the nine months ended September 30, 2016. The decrease in general and administrative expenses during the nine months ended September 30, 2017 was primarily due to a decrease in business development, market research and pre-commercialization activities related to TLANDO, a decrease in legal fees related to patent litigation, and a decrease in personnel costs.

Inovio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Inovio, 2017, NOV 8, 2017, View Source [SID1234521782]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On November 8, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the third quarter ended September 30, 2017, and recent company developments (Press release, TG Therapeutics, NOV 8, 2017, View Source [SID1234521743]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "The third quarter was an extremely productive and exciting time for the Company highlighted by the completion of enrollment into our UNITY-CLL Phase 3 study, the commencement of our global Phase 3 trials in multiple sclerosis, and the additional clarity we received from the FDA regarding the GENUINE study. We look forward, over the next 6-12 months, to what we believe will be a number of value creating milestones, including overall response data from UNITY-CLL and additional data supporting our strategy in NHL." Mr. Weiss continued, "From a financial perspective, we remain well positioned through these important milestones."

Third Quarter and Recent Highlights

● ASH 2017: The Company looks forward to the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting where data presentations will include three clinical poster presentations and three pre-clinical poster presentations.
● TG-1101 Data at ECTRIMS: Updated results from the ongoing Phase 2 Study of TG-1101 in patients with Multiple Sclerosis were presented at the 7th Joint ECTRIMS-ACTRIMS Meeting demonstrating robust activity on B-cell depletion, reduction of T1 Gd enhancing lesions, and positive effects on disability measurements.
● UNITY-CLL Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in October, which should allow for top-line data on Overall Response Rate (ORR) in Q2 2018.
● GENUINE Update: The Company met with the FDA and confirmed that accelerated approval based on the ORR results from GENUINE would be a review issue and that the potential may exist for full approval based on the PFS results from the GENUINE study.
● TGR-1202 Grant: TGR-1202 (umbralisib) was selected for a grant by the National Multiple Sclerosis Society to support the development of TGR-1202 as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
● Anti-PD-L1 Entered the Clinic: The Company’s anti-PD-L1 monoclonal antibody commenced clinical development, with the first patient being dosed in a Phase I clinical trial.
● ULTIMATE Phase 3 Trials in MS: Received a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and II studies in relapsing forms of multiple sclerosis and commenced enrollment into the global studies.
● UNITY-NHL: Announced successful outcome from the first pre-planned interim analysis by independent DSMB of the DLBCL cohort in the UNITY-NHL Phase 2b trial, where based on pre-set hurdles of ORR, the DSMB recommended continued enrollment in the TG-1101 plus TGR-1202 combination arm (also referred to as the U2 combination) and replacement of the single agent TGR-1202 arm with U2 plus bendamustine.

Financial Results for the Third Quarter 2017

● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $91.8 million as of September 30, 2017, as compared to $86.5 million at June 30, 2017.

● R&D Expenses: Research and development (R&D) expenses were $27.1 million and $76.5 million for the three and nine months ended September 30, 2017, respectively, compared to $21.8 million and $46.9 million for the three and nine months ended September 30, 2016. Included in research and development expense for the three and nine months ended September 30, 2017 was $7.1 million and $20.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and nine months ended September 30, 2017, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

● G&A Expenses: General and administrative (G&A) expenses were $4.5 million and $11.3 million for the three and nine months ended September 30, 2017, respectively, as compared to $3.2 million and $8.1 million for the three and nine months ended September 30, 2016. The increase in G&A expenses for the nine months ended September 30, 2017 relates primarily to non-cash compensation expenses related to equity incentive grants recognized during 2017. We expect G&A expenses to remain relatively constant through the remainder of 2017.

● Net Loss: Net loss was $31.5 million and $87.6 million for the three and nine months ended September 30, 2017, respectively, compared to a net loss of $24.8 million and $54.6 million for the three and nine months ended September 30, 2016, respectively.

● Financial Guidance: The Company believes its cash and cash equivalents will be sufficient to fund the Company’s planned operations through 2018.

Conference Call Information

The Company will host an investor conference call today, November 8, 2017, at 8:30am ET, to discuss the Company’s third quarter 2017 financial results and provide a business outlook for the remainder of 2017.

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 2017 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.