On March 3, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported its financial and operational results for the year ended December 31, 2019 (Press release, Sierra Oncology, MAR 3, 2020, View Source [SID1234555128]).

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"Our focus is on achieving regulatory and commercial success with our Phase 3 drug candidate, momelotinib, which may become the first approved therapeutic capable of treating all three hallmarks of myelofibrosis; anemia, constitutional symptoms and enlarged spleen. Given its potentially unique profile, momelotinib could command an important role in the poorly addressed anemic and thrombocytopenic first-line and second-line myelofibrosis patient populations," said Dr. Nick Glover, President and CEO of Sierra Oncology. "During the fourth quarter of 2019, we launched the MOMENTUM Phase 3 clinical trial, setting Sierra on course to deliver top-line data in late 2021 and positioning momelotinib for potential registration filing in 2022. Our focus now is on activating global clinical trial sites over the coming months and driving enrollment for MOMENTUM, and we look forward to providing ongoing updates on our progress throughout this year."

"Myelofibrosis is characterized by progressive anemia and thrombocytopenia, and current JAK inhibitor therapies can induce or further exacerbate this myelosuppression, limiting their use in first line treatment and resulting in a population of second line patients who are no longer able to benefit from such therapies. Conversely, we believe momelotinib’s ability to address anemia, while either sparing platelets or reversing thrombocytopenia, are important potential drivers of its commercial opportunity. We plan to further highlight momelotinib’s differentiated durability, safety and efficacy profile during 2020 with additional dissemination of emerging data from the two previously completed SIMPLIFY Phase 3 trials that compared momelotinib head-to-head with ruxolitinib," added Dr. Glover. "Given momelotinib’s distinct clinical profile, we believe our drug candidate is also well positioned amongst the JAK inhibitor class for emerging combination approaches targeting myelofibrosis."

2019 Highlights for Momelotinib:

During the second quarter, Sierra obtained regulatory clarity with the FDA and announced the design of the MOMENTUM Phase 3 clinical trial intended to support the potential registration of momelotinib. Sierra also announced that Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, had been named Chief Investigator of the MOMENTUM trial.
Sierra also reported during the second quarter that the FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.
During the fourth quarter, Sierra launched the MOMENTUM clinical trial for patients with myelofibrosis. The randomized double-blind global Phase 3 trial is designed to confirm the efficacy of momelotinib on myelofibrosis symptoms, transfusion independence and splenomegaly, as compared to danazol. The trial is targeting enrollment of 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05). Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib in prior clinical studies, will form the basis of the global registration strategy for momelotinib.
During the fourth quarter, new analyses of RBC transfusion data from SIMPLIFY-1, a double-blind Phase 3 trial of momelotinib head-to-head versus ruxolitinib in JAK inhibitor naïve patients, were presented in a poster by Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida. These analyses demonstrated that patients who received momelotinib had significantly decreased transfusion requirements compared to those treated with ruxolitinib, including an odds ratio of nearly 10 for receiving no transfusions during the 24-week study period. Transfusion dependency and moderate to severe anemia are critical negative prognostic factors for overall survival in myelofibrosis.
Year End 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $53.2 million for the year ended December 31, 2019, compared to $41.1 million for the year ended December 31, 2018. In addition to a non-cash charge of $10.5 million pertaining to the obligation to issue common stock and a warrant in consideration for meaningfully reduced royalty rates and elimination of a near term milestone payment in an amendment to our Asset Purchase Agreement with Gilead Sciences, Inc. (Gilead), the increase was primarily due to costs related to momelotinib, including a $12.2 million increase in clinical trial and development costs, a $2.5 million increase in third-party manufacturing costs and a $1.4 million increase in personnel-related and allocated overhead costs. These increases were partially offset by a $3.0 million upfront fee paid to Gilead to acquire momelotinib in 2018 and decreases in SRA737 and SRA141 costs, including a $5.0 million decrease in clinical trial costs primarily related to SRA737, a $4.3 million decrease in third-party manufacturing costs, and a $2.1 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $3.9 million and $4.5 million for the year ended December 31, 2019 and 2018, respectively.

General and administrative expenses were $13.7 million for the year ended December 31, 2019, compared to $14.3 million for the year ended December 31, 2018. This decrease was primarily due to decreases in personnel-related and allocated overhead costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $2.3 million for the year ended December 31, 2019 and 2018, respectively.

Other income (expense), net was $21.4 million of other expense, net for the year ended December 31, 2019, compared to $1.8 million of other income, net for the year ended December 31, 2018. The increase was primarily attributable to a non-cash charge of $20.9 million related to the change in fair value of warrant liabilities and offering expenses of $1.3 million pertaining the issuance of the warrants in the 2019 public offering and a $0.7 million increase in interest expense incurred on the term loan that was repaid in December 2019.

For the year ended December 31, 2019, Sierra incurred a GAAP net loss of $88.3 million compared to a GAAP net loss of $53.3 million for the year ended December 31, 2018. The GAAP net loss for the year ended December 31, 2019 includes a non-cash charge of $20.9 million, related to the change in fair value of warrant liabilities included in other income (expense), net and a non-cash charge of $10.5 million pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above. In January 2020, Sierra fulfilled this obligation, issuing 725,283 shares of common stock to Gilead and a warrant to purchase an equivalent amount of common stock.

Non-GAAP adjusted net loss was $51.2 million for the year ended December 31, 2019, compared to a non-GAAP adjusted net loss of $46.5 million for the year ended December 31, 2018. Non-GAAP adjusted net loss excludes expenses related to the change in fair value of warrant liabilities, the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

Cash and cash equivalents totaled $147.5 million as of December 31, 2019, compared to $106.0 million as of December 31, 2018. This increase was due to an underwritten public offering in November 2019, pursuant to which the company raised gross proceeds of $103.0 million (net proceeds of $97.7 million). This increase was offset by cash used in operating activities of $51.2 million and the full repayment of a term loan in December 2019 in the amount of $5.4 million, including prepayment and final payment fees associated with terminating the debt facility.

In January 2020, all of the Series A convertible voting preferred stock converted into shares of common stock. As of January 31, 2020, there were 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. At December 31, 2019 were 327,862 shares issuable upon exercise of stock options and a warrant.

The company anticipates its current resources will be sufficient to execute on its development strategy for momelotinib into the second half of 2022. In addition, the Series B warrants issued in the underwritten public offering in November 2019, may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from the MOMENTUM Phase 3 trial. If these Series B warrants are fully exercised, the company will receive approximately $34.0 million in proceeds.

Conference Call Information

Today at 8:00 am Eastern Time, Sierra’s management will host a conference call to discuss the company’s and operational results for 2019 and provide a business update for 2020.

Date and Time: Tuesday, March 3 at 8:00 am ET

Domestic (Toll Free- US): 1-888-394-8218
International (Toll): 1-323-701-0225
Conference ID: 1052679
Webcast Link: www.sierraoncology.com
Direct Link: View Source

Call registration is available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

On March 3, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA), a leading global provider of molecular diagnostics and sample preparation technologies, reported that their boards of directors, as well as the managing board of QIAGEN N.V., have unanimously approved Thermo Fisher’s proposal to acquire QIAGEN for €39 per share in cash (Press release, Qiagen, MAR 3, 2020, View Source [SID1234555127]). The offer price represents a premium of approximately 23% to the closing price of QIAGEN’s common stock on the Frankfurt Prime Standard on March 2, 2020, the last trading day prior to the announcement of the transaction. Thermo Fisher will commence a tender offer to acquire all of the ordinary shares of QIAGEN.

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The transaction values QIAGEN at approximately $11.5 billion at current exchange rates, which includes the assumption of approximately $1.4 billion of net debt.

"We are excited to bring together our complementary offerings to advance our customers’ important work, from discovery to diagnostics," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "This acquisition provides us with the opportunity to leverage our industry-leading capabilities and R&D expertise to accelerate innovation and address emerging healthcare needs. For shareholders, we expect the transaction to be immediately accretive and to generate significant cost and revenue synergies."

QIAGEN is a leading provider of life science and molecular diagnostic solutions and employs approximately 5,100 people at 35 locations in more than 25 countries. The company generated 2019 revenue of $1.53 billion. Its sample preparation technologies are used to extract, isolate and purify DNA, RNA and proteins from a wide range of biological samples. The company’s assay technologies are then used to amplify and

enrich these biomolecules to make them readily accessible for analysis. In addition, QIAGEN’s instruments can be used to automate these workflows, while its bioinformatics systems provide customers with relevant, actionable insights.

"Our vision at QIAGEN has always been to make improvements in life possible with our differentiated Sample to Insight molecular testing solutions," said Thierry Bernard, interim chief executive officer of QIAGEN N.V. and senior vice president, head of the molecular diagnostics business area. "This strategic step with Thermo Fisher will enable us to enter a promising new era and will give our employees the opportunity to have an even greater impact. The combination is designed to deliver significant cash value to our shareholders, while enabling us to accelerate the expansion of our solutions to provide customers worldwide with breakthroughs that advance our knowledge about the science of life and improve health outcomes."

Casper concluded, "We look forward to welcoming QIAGEN’s employees to Thermo Fisher and are excited about the new opportunities we’ll have to advance precision medicine through new molecular diagnostics and improved life sciences workflows."

Benefits of the Transaction

Expands Specialty Diagnostics Portfolio with Attractive Molecular Diagnostics Capabilities, Including Infectious Disease Testing. Thermo Fisher has built leading specialty diagnostics capabilities, including allergy and autoimmunity, transplant diagnostics and clinical oncology testing. QIAGEN has a strong presence in molecular diagnostics with a product portfolio focused on infectious disease and other growth opportunities. The combined company will accelerate the development of higher-specificity, faster and more comprehensive tests that may improve patient outcomes and reduce the cost of care.

Complementary Offering Enhances Unique Value Proposition for Life Sciences Customers. For life sciences researchers, QIAGEN’s innovative sample preparation, assay and bioinformatics technologies are complementary to Thermo Fisher’s genetic analysis and biosciences capabilities. As an example, with an expanded portfolio, Thermo Fisher will be able to provide research customers with broader capabilities to accelerate discovery and enable scientific breakthroughs.

Commercial and Geographic Reach Expand Customer Access. Thermo Fisher will be able to leverage its extensive commercial reach, including its Fisher Scientific customer channels and comprehensive e-commerce platforms, to expand customer access to QIAGEN’s product portfolio. Furthermore, given Thermo Fisher’s leading presence in high-growth and emerging markets, QIAGEN will be able to further penetrate these regions.

Delivers Attractive Financial Benefits through the PPI Business System, Including Proven Integration Approach. The transaction is expected to be immediately accretive to Thermo Fisher’s adjusted EPS after close. Thermo Fisher expects to realize total synergies of $200 million by year three following the close, consisting of $150 million of cost synergies and $50 million of adjusted operating income1 benefit from revenue synergies.

Financing and Approvals

The transaction, which is expected to be completed in the first half of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an Extraordinary General Meeting of QIAGEN’s shareholders, and completion of the tender offer.

Adjusted earnings per share and adjusted operating income are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

Thermo Fisher has obtained committed bridge financing. Permanent funding is expected to come from cash on hand and the issuance of new debt. The transaction is not subject to any financing condition.

Advisors

J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel. For QIAGEN, Goldman Sachs International is serving as lead financial advisor and Barclays Bank PLC is serving as financial advisor, while De Brauw Blackstone Westbroek NV, Linklaters LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. are serving as legal counsel.

Conference Call and Webcast

Thermo Fisher will host a conference call and webcast at 8:30 a.m. Eastern Time today to provide more information on this announcement. The webcast and accompanying slides can be accessed in the Investors section of www.thermofisher.com. An audio archive of the call will be available in that section of the website until March 17, 2020.

On March 3, 2020 Pfizer Inc. (NYSE:PFE) reported investors and the general public to listen to a webcast of a discussion with Charles Triano, Senior Vice President, Investor Relations, at the Cowen and Company 40th Annual Healthcare Conference on Tuesday, March 3, 2020 at 10:40 a.m. Eastern Standard Time (Press release, Pfizer, MAR 3, 2020, View Source [SID1234555126]).

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To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

On March 3, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) reported that their joint collaboration and license agreement for the further development and global commercialization of MorphoSys’ investigational compound tafasitamab (MOR208) has received antitrust clearance and becomes effective today (Press release, MorphoSys, MAR 3, 2020, View Source [SID1234555125]).

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The agreement becoming effective triggers the $750 million upfront payment by Incyte to MorphoSys, as well as Incyte’s equity investment into MorphoSys of $150 million in new American Depositary Shares (ADS) within the defined timelines.

Additional information about the collaboration can be found in MorphoSys’ and Incyte’s press releases dated January 13, 2020, as well as in MorphoSys’ Form 6-K filed with the Securities and Exchange Commission (SEC) on January 14, 2020 and in Incyte’s Form 8-K filed with the SEC on January 15, 2020.

The U.S. Food and Drug Administration (FDA) recently accepted filing of MorphoSys’ Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is August 30, 2020.

About Tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, outside the U.S. Incyte will have exclusive commercialization rights.

Tafasitamab is being clinically investigated as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label Phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with r/r DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The ongoing Phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with r/r CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g., ibrutinib) in combination with idelalisib or venetoclax.

On March 3, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2019 and recent company developments, along with a business outlook for 2020 (Press release, TG Therapeutics, MAR 3, 2020, View Source [SID1234555124]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2019 was a transformational year for TG as we were able to report positive outcomes for umbralisib in both previously treated marginal zone lymphoma and follicular lymphoma from the UNITY-NHL trial. We also confirmed a submission pathway with the FDA and early this year commenced a single rolling submission based on these data, which we hope to complete in the first half of this year." Mr. Weiss continued, "Looking forward, we expect 2020 to be yet another impactful year as we await the topline results from our Phase 3 programs in CLL and MS and potentially our first FDA approval around year-end."

2019 Highlights & Recent Developments

Marginal Zone Lymphoma & Follicular Lymphoma:

oReceived breakthrough therapy designation (BTD) for patients with marginal zone lymphoma (MZL) who have received at least one prior therapy including an anti-CD20 regimen, and orphan drug designation for umbralisib for the treatment of patients with MZL.

oAnnounced positive outcome from the MZL cohort of the UNITY-NHL Phase 2b trial, which met the primary endpoint of Overall Response Rate (ORR), as determined by Independent Review Committee (IRC).

oPresented interim safety and efficacy data from the MZL cohort of UNITY-NHL during oral presentations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, the 55th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the 2019 International Conference on Malignant Lymphoma (ICML).

oAnnounced positive outcome from the follicular lymphoma (FL) cohort of the UNITY-NHL Phase 2b trial, with ORR results meeting the Company’s prespecified 40 – 50% target, as determined by IRC. The Company plans to present the data at a future medical conference.

oReceived guidance from the FDA allowing submission of a single New Drug Application (NDA) for MZL and FL indications. In January 2020, a rolling NDA submission for umbralisib to treat adult patients with previously treated MZL and FL was initiated, with completion of submission targeted for first half of 2020.

Chronic Lymphocytic Leukemia:

oAwaiting topline progression free survival (PFS) results from the Company’s Phase 3 UNITY-CLL trial evaluating "U2" (the combination of umbralisib and ublituximab) in patients with frontline and previously treated chronic lymphocytic leukemia (CLL).

oFinal long-term results from the Phase 3 GENUINE study demonstrated that ublituximab in combination with ibrutinib improved PFS, as determined by IRC.

oPresented triple therapy data at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from the Phase 1/2 study of ublituximab in combination with umbralisib and venetoclax, in patients with relapsed/refractory CLL, during an oral session.

Multiple Sclerosis:

oUpdated Phase 2 extension trial data for ublituximab in relapsing forms of multiple sclerosis (RMS), as well as the ULTIMATE I & II Phase 3 RMS program study design and demographic data, were presented at the 35th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

oAwaiting topline data from the Company’s Phase 3 ULTIMATE I & II trials evaluating ublituximab in patients with RMS.

Early Pipeline:

oTG-1801: Commenced a Phase 1 first-in-human, dose-escalation study of TG-1801, the Company’s anti-CD47/CD19 bispecific antibody, in patients with relapsed or refractory B-cell lymphoma and presented the first preclinical data of TG-1801 at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) annual congress.

oTG-1701: Presented the first clinical data from TG-1701, the Company’s once daily, oral, BTK inhibitor, as a single agent and as a triple therapy in combination with U2 at ASH (Free ASH Whitepaper) 2019.

Key Objectives for 2020

Report topline PFS results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with frontline and previously treated CLL, and if successful, target a potential New Drug Application (NDA)/Biologics Licensing Application (BLA) submission by year-end.

Complete rolling NDA submission for umbralisib in patients with previously treated MZL and FL, in the first half of 2020.

Report topline results from the Phase 3 ULTIMATE I & II trials in RMS, in the second half of 2020.

Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801.

Financial Results for the Fourth Quarter and Full Year 2019

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation and non-cash in-licensing expense) was $29.5 million and $148.3 million for the three and twelve months ended December 31, 2019, respectively, compared to $51.1 million and $149.8 million for the three and twelve months ended December 31, 2018, respectively. The decrease in R&D expense is primarily attributable to the winding down of our late-stage clinical development programs during the year ended December 31, 2019.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.9 million and $9.5 million for the three and twelve months ended December 31, 2019, respectively, as compared to $1.7 million and $7.9 million for the three and twelve months ended December 31, 2018, respectively.

Net Loss: Net loss was $39.6 million and $172.9 million for the three and twelve months ended December 31, 2019, respectively, compared to a net loss of $53.9 million and $173.5 million for the three and twelve months ended December 31, 2018, respectively. Excluding non-cash items, the net loss for the three and twelve months ended December 31, 2019 was approximately $34.0 million and $161.4 million, respectively, compared to a net loss of $52.4 million and $156.6 million for the three and twelve months ended December 31, 2018, respectively.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $140.4 million as of December 31, 2019. The Company believes its cash, cash equivalents and investment securities on hand as of December 31, 2019, will be sufficient to fund the Company’s planned operations well into 2021.

Conference Call Information

The Company will host a conference call today, March 3, 2020, at 8:00 AM ET, to discuss the Company’s fourth quarter and year-end 2019 financial results and provide a business outlook for 2020.

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 2019 Earnings Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source 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.