On March 8, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2017 and provided recent company developments along with a business outlook for 2018 (Press release, TG Therapeutics, MAR 8, 2018, View Source [SID1234524542]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2017 was a truly pivotal year for our company with the presentation of positive results from our first Phase 3 trial, the GENUINE trial, the completion of enrollment in our second Phase 3 trial, the UNITY-CLL trial, and the launch of our Phase 3 ULTIMATE trials in Multiple Sclerosis. These major milestones along with strong enrollment in our UNITY-NHL registration directed program sets the stage for an even more impactful 2018 and 2019." Mr. Weiss continued, "We are extremely pleased to enter 2018 with a healthy balance sheet and look forward to multiple value creating milestones this year, including presenting topline ORR data from our Phase 3 UNITY-CLL trial and, ideally, filing our first BLA and/or NDA later in the year."

2017 Highlights

● Orphan Drug Designation: Orphan drug designation was granted for the combination of ublituximab (TG-1101) and umbralisib (TGR-1202) for the treatment of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma (DLBCL).
● Ublituximab Publication: Data from the Phase 1/2 trial of ublituximab was published in the British Journal of Haematology.
● GENUINE Phase 3 Data: Positive data from the Phase 3 GENUINE trial of ublituximab in combination with ibrutinib in patients with high risk CLL was presented at the ASCO (Free ASCO Whitepaper) annual meeting and Lugano Lymphoma Conference.
● 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, commenced enrollment into the global studies and presented clinical and MRI data from the supportive Phase 2 trial of ublituximab in RMS at various conferences throughout the year.
● UNITY-CLL Phase 3 Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in October 2017
● Umbralisib Grant: Umbralisib was selected for a grant by the National Multiple Sclerosis Society to support the development of umbralisib as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
● Anti-PD-L1 Entered the Clinic: The Company advanced its anti-PD-L1 monoclonal antibody into clinical development, with the first patient being dosed in a Phase I clinical trial.

Key Objectives for 2018

● UNITY-CLL Phase 3 Trial: We plan to present top-line overall response rate results from our UNITY-CLL Phase 3 trial in both front line and relapsed or refractory CLL and also prepare a BLA/NDA filing for accelerated approval.
● GENUINE Phase 3 BLA Filing: A Biologics Licensing Application (BLA) filing will be prepared for ublituximab plus ibrutinib for potential accelerated approval based on the results from GENUINE.
● UNITY-NHL: Aggressively enroll into all cohorts of the UNITY-NHL clinical trial with the goal of completing enrollment into all cohorts.
● ULTIMATE Phase 3 Trials: Aggressively recruit to our Phase 3 MS trials.
● Data Presentations: Present new and updated data from ongoing trials at various scientific meetings throughout the year.

Financial Results for the Fourth Quarter and Full Year 2017

● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $84.8 million as of December 31, 2017. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of December 31, 2017 (excluding our first quarter 2018 operations) are approximately $114.6 million, after giving effect to $29.8 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the first quarter of 2018.

● R&D Expenses: Research and development (R&D) expenses were $26.0 million and $102.5 million for the three and twelve months ended December 31, 2017, respectively, compared to $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2017, in addition to our other clinical expenses, are $6.1 million and $26.6 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 twelve months ended December 31, 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 $5.1 million and $16.3 million for the three and twelve months ended December 31, 2017, respectively, as compared to $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively. The increase in G&A expenses for the three and twelve months ended December 31, 2017 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2017.

● Net Loss: Net loss was $30.9 million and $118.5 million for the three and twelve months ended December 31, 2017, respectively, compared to a net loss of $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively.

● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2017, inclusive of the proceeds raised subsequent to the year-end will be sufficient to fund the Company’s planned operations through mid-2019.

Conference Call Information

The Company will host an investor conference call today, Thursday, March 8, 2018 at 8:30am ET, to discuss the Company’s 2017 financial results and provide a business outlook for 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 Year-End 2017 Earnings Call. A live audio webcast of this conference call 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 March 8, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that fourth quarter and year-end 2017 financial and operating results after the close of the U.S. financial markets on Monday, March 12, 2018. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET (Press release, Iovance Biotherapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337036 [SID1234524541]).

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In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1497629. The live webcast can be accessed under "News & Events" in the "Investors" section of the Company’s website at View Source or you may use the link: View Source

A replay of the call will be available from March 12, 2018 at 7:30 p.m. ET to April 18, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 1497629. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.

On March 8, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that members of the company’s management team will present at Cowen & Company’s 38th Annual Healthcare Conference on Wednesday, March 14, 2018, at 10:40 a.m. ET in Boston (Press release, Foundation Medicine, MAR 8, 2018, View Source [SID1234524540]).

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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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A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company’s website for 90 days.

On March 8, Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported that David Domzalski, Chief Executive Officer, will present a corporate overview and business update at the Barclays Global Healthcare Conference 2018, taking place March 13-15 at the Lowe’s Miami Beach Hotel in Miami, Florida (Press release, Foamix, MAR 8, 2018, View Source [SID1234524539]).

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Barclays Global Healthcare Conference 2018
Date: Wednesday, March 14
Time: 10:45am Eastern Time
Location: Lowe’s Miami Beach Hotel
Webcast: https://cc.talkpoint.com/barc002/031318a_as/?entity=42_2H5CIPS

On March 8, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2017 (Press release, Curis, MAR 8, 2018, View Source [SID1234524538]).

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"2017 exemplified Curis’s business strategy, marking the Company’s first time with three anti-cancer drug candidates in clinical development" said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We are excited about CUDC-907 treatment providing durable responses in nearly 1 in 4 DLBCL patients whose cancers have MYC alterations. We are working closely with regulatory authorities to define a pivotal path to register CUDC-907 in this patient population, which has no viable treatment options."

"Our progress with testing CA-170, the first and only oral small molecule checkpoint inhibitor, has now extended beyond the Phase 1 trial, with our partner Aurigene having initiated a Phase 2 trial in India. This will greatly accelerate access to select populations of patients that have not experienced prior immunotherapy."

"As noted, with initiation of patient enrollment in CA-4948’s Phase 1 lymphoma study, for the first time, Curis has 3 different cancer drugs in clinical testing at the same time. We are excited about the prospects for these drugs and their value to Curis’s success in 2018."

Full Year and Fourth Quarter 2017 Financial Results

For the year ended December 31, 2017, Curis reported a net loss of $53.3 million, or $(0.36) per share on both a basic and diluted basis, as compared to a net loss of $60.4 million, or $(0.45) per share on both a basic and diluted basis in 2016. For the fourth quarter of 2017, Curis reported a net loss of $8.0 million or $(0.05) per share on both basic and diluted basis, as compared to a net loss of $11.3 million, or $(0.08) per share on both basic and diluted basis for the same period in 2016. The net loss for the year ended December 31, 2016, includes a non-cash in-process research and development charge of $18.0 million related to the amendment of Curis’s license agreement with Aurigene.

Revenues for the year ended December 31, 2017 were $9.9 million, as compared to $7.5 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2017 and 2016 were $3.3 million and $2.4 million, respectively.

Operating expenses were $59.7 million for the year ended December 31, 2017, as compared to $65.6 million for the same period in 2016. Operating expenses for the fourth quarter of 2017 were $10.4 million, as compared to $13.1 million for the same period in 2016, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the year ended December 31, 2017, as compared to $0.4 million for the same period in 2016. Cost of royalty revenues were $0.2 million for the fourth quarter of 2017, as compared to $0.1 million for the same period in 2016.

In-Process Research and Development Expense. The Company recorded a one-time in-process research and development expense of $18.0 million for the year ended December 31, 2016, related to the issuance of common stock to Aurigene. These shares were issued as consideration for the rights granted under the terms of the September 2016 amendment to the collaboration agreement.

Research and Development Expenses. Research and development expenses were $45.1 million for the year ended December 31, 2017, as compared to $31.6 million for the same period in 2016. The increase was primarily due to two payments to Aurigene for $3.8 million each, for an exclusivity option which were paid in January 2017 and September 2017 as well as increased costs related to ongoing clinical activities for CA-170. Employee-related expenses increased over the prior year period primarily due to higher stock based compensation and personnel costs. Research and development expenses were $6.9 million for the fourth quarter of 2017, as compared to $9.2 million for the same period in 2016.

General and Administrative Expenses. General and administrative expenses were $14.1 million for the year ended December 31, 2017, as compared to $15.6 million for the same period in 2016. The decrease in general and administrative expenses was driven primarily by lower legal, professional and consulting services and other administrative expenses, offset slightly by higher stock-based compensation for the period. General and administrative expenses were $3.3 million for the fourth quarter of 2017, as compared to $3.8 million for the same period in 2016.

Other expense, net was $3.6 million for the year ended December 31, 2017, as compared to $2.4 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to the debt obligations of Curis Royalty (a wholly owned subsidiary of Curis). The increase in interest expense in the current year was related to a higher principal balance of Curis Royalty’s outstanding debt with HealthCare Royalty, which was refinanced in the first quarter of 2017. Other expense, net was $0.9 million for the fourth quarter of 2017, as compared to $0.6 million for the same period in 2016.

As of December 31, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $60.2 million and there were approximately 164.2 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, CUDC-907:

In December 2017, investigators presented results from the combined analysis of the Phase 1 and Phase 2 trial results of CUDC-907 in patients with relapsed/refractory DLBLC, including those with MYC-altered disease, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

In December 2017, Curis scientists presented non-clinical results demonstrating significant anti-tumor activity when CA-4948 was combined with the BCL2 antagonist drug venetoclax, at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s annual meeting in Atlanta, Georgia.
In January 2018, Curis announced initiation of patient dosing in a Phase 1 trial of CA-4948 for treatment of patients with lymphoma. CA-4948 was discovered at Aurigene and is the second licensed program from the Curis-Aurigene collaboration to enter the clinic.
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):

In November 2017, investigators presented preliminary results from the dose escalation stage of the Phase 1 trial of CA-170 in patients with advanced solid tumors or lymphomas, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Curis collaborator, Aurigene, initiated patient enrollment of cancer patients in a Phase 2 clinical study of CA-170 at trial sites in India.
Immuno-oncology, CA-327 (PDL1 and TIM3 antagonist; Aurigene collaboration):

In November 2017, Curis scientists presented non-clinical results demonstrating CA-327’s ability to modulate tumor immune profile in mouse models, as well as its anti-cancer activity as a single agent or in combination with CA-170, at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in National Harbor, Maryland.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through April 2018:

Cowen & Company 38th Annual Health Care Conference (March 12-14) in Boston
Conference Call Information

Curis management will host a conference call today, March 8, 2018, at 8:30 a.m. EST, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EST. The conference call can also be accessed on the Curis website at www.curis.com in the Investors sectio