On November 8, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its first quarter ended September 30, 2017 (Press release, MEI Pharma, NOV 8, 2017, View Source [SID1234521744]).

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"In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We are well positioned for a momentous year ahead, with a healthy cash balance and a series of key milestones in each of our clinical programs."

Upcoming Milestones

Pracinostat

Expecting results from Stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.
ME-401

Expecting to initiate combination study with Rituxan in indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in the fourth quarter of 2017.
Expecting results from proof-of-concept study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma to be presented at a scientific meeting in the first half of 2018.
Voruciclib

Expecting to initiate Phase1/2 single-agent study in relapsed/refractory B lymphocyte malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta) in the second quarter of 2018.
ME-344

Expecting interim results from the proof-of-concept study in human epidermal growth factor receptor 2 (HER2) negative breast cancer in combination with bevacizumab (marketed as Avastin) in the first half of 2018.
Financial Highlights

As of September 30, 2017, MEI Pharma had $47.0 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019.
Cash used in operating activities was $6.6 million for the three months ended September 30, 2017, compared to cash provided by operating activities of $8.8 million for 2016. Included in cash expenditures for the three months ended September 30, 2017 was $1.9 million cash paid for the voruciclib acquisition. Included in the cash provided by operating activities in 2016 is the $15 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $6.7 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
General and administrative expenses were $2.5 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The decrease was primarily due to professional service costs incurred in 2016 related to the Helsinn license agreement.
Revenues were $0.3 million for the three months ended September 30, 2017, compared to $1.1 million in 2016. The decrease is related to activities performed pursuant to the Helsinn license agreement.
Net loss was $8.8 million, or $0.24 per share, for the three months ended September 30, 2017, compared to a net loss of $4.3 million, or $0.12 per share for the three months ended September 30, 2016

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]).

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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.

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]).

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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.

On November 8, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported new preclinical data for RXDX-106 – a novel immunomodulatory agent that demonstrated potent anti-tumor activity, alone and in combination with checkpoint inhibitors, by modulating the tumor microenvironment (TME) through TYRO3, AXL, and MER (TAM) receptor tyrosine kinase (RTK) inhibition (Press release, Ignyta, NOV 8, 2017, View Source [SID1234521740]). In the TME, TAM RTKs contribute to cancer cell evasion of the immune system and progression by promoting anti-inflammatory and pro-tumorigenic activities. RXDX-106 is a potent and selective TAM inhibitor in late-stage preclinical development, designed to reverse TAM RTKs-mediated immunosuppression and inhibit tumor growth and progression. The data were presented in two posters (abstracts P90 and P473) at the 32nd Annual SITC (Free SITC Whitepaper) Meeting, in National Harbor, Maryland.

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"We are excited by the immunomodulatory effects of RXDX-106 observed in a variety of preclinical models, and its potential to elicit and potentiate an immune response to cancer, both as a single agent and combined with checkpoint inhibitors," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "RXDX-106 represents a new class of immuno-oncologic precision medicines by targeting the TAM RTKs in the tumor microenvironment. We look forward to bringing it into clinical trials in early 2018 to continue our efforts to help patients in their fight against cancer."

Using complementary approaches, including gene and protein modulation, RXDX-106 treatment resulted in the recruitment of both innate and adaptive immune cell subtypes to the TME. Using RNA sequencing, differential expression of immunomodulatory genes were observed in RXDX-106 treated compared to vehicle treated mouse cohorts, indicative of an enrichment in pro-inflammatory/anti-tumorigenic immune cell infiltration. In addition, RXDX-106 demonstrated immune-mediated, single-agent anti-tumor activity in multiple tumor models that was further enhanced by combination therapy with immune checkpoint inhibitors. These data further demonstrate the ability of RXDX-106 to activate both innate and adaptive immunity, as observed by treatment-mediated changes in relevant cytokine levels and immune cell biomarkers, and regulating cross-talk between immune and cancer cells. These promising early findings support further development of RXDX-106 to potentially treat a wide variety of cancers.

On November 8, 2017 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will be presenting at the following investor conferences (Press release, AVEO, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315291 [SID1234521737]):

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Jefferies 2017 London Healthcare Conference on Wednesday, November 15, 2017 at 4:00 p.m. Greenwich Mean Time. The conference is being held at the Waldorf Hilton Hotel in London.
Piper Jaffray 29th Annual Healthcare Conference on Tuesday, November 28, 2017 at 10:00 a.m. Eastern Time. The conference is being held at the Lotte New York Palace Hotel.
A live webcast of the presentations can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.