On February 28, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late- stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported its cash position as of December 31, 2021 and revenues for 2021 (Press release, Genfit, MAR 1, 2022, View Source [SID1234609221]).

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Financials

As of December 31, 2021, the Company’s cash and cash equivalents amounted to €258.8 million compared with €171.0 million, as of December 31, 2020. This amount includes:

•A €120 million non-refundable upfront payment from Ipsen received in December 2021, as well as €24 million in VAT collected on that amount
•A €28 million equity investment from Ipsen in December 2021
•A €7.9 million Research Tax Credit 2020 reimbursement received in October 2021
•A €2.25 million subsidized loan from Bpifrance in November 2021 in addition to the State Guaranteed Loans received in June and July 2021

As of June 30, 2021, cash and cash equivalents amounted to €104.4 million.

The solid cash position as of December 31, 2021 takes into account the collaboration and license agreement signed with Ipsen in December 2021 which gives Ipsen exclusive worldwide2 license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor for people living with Primary Biliary Cholangitis (PBC), in return for a €120 million upfront payment. In addition to the upfront payment GENFIT is eligible to receive up to €360 million in milestone payments as well as tiered double-digit royalties of up to 20%. To underscore the long-term commitment represented by this partnership, Ipsen also purchased newly issued GENFIT equity representing 8% post-issuance through a €28 million investment in GENFIT, becoming one of the largest shareholders.

1Unaudited financial information under IFRS
2With the exception of China, Hong Kong, Taiwan, and Macau where Terns Pharmaceuticals holds the exclusive license to develop and commercialize elafibranor

1 Pascal Prigent, CEO of GENFIT, commented: "This breakthrough strategic partnership with Ipsen marks the beginning of a new chapter for GENFIT. With a considerably improved financial situation, we’re now in a good position to accelerate our development."

Revenues3

Revenues for 2021 were €80.06 million compared to €0.76 million for 2020. This mainly results from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million is recognized as 2021 revenue, after deduction of €40 million deferred revenue, which will gradually be recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with the IFRS 15 norms.

As a comparison, revenues for 2020 mainly resulted from the licensing agreements with Labcorp to roll out the NIS4 diagnostic technology in NASH and the sale of goods and services provided pursuant to the collaboration and license agreement with Terns Pharmaceuticals.

A note about the COVID-19 pandemic and its potential consequences on our business

During this evolving crisis, our priorities continue to be to ensure the safety and well-being of our employees, of the patients and healthcare professionals involved in our clinical trials, as well as the integrity of our ongoing clinical trials. We remain committed to ensuring business continuity and have been monitoring the situation closely.

We have worked with our contract research organizations (CRO), trial sites and investigators to regularly revise our program execution estimations to take into account the evolution of the pandemic situation and its impact on our activities.

As a result of measures implemented in consultation with our CRO we were able to minimize disruption to our ELATIVE Phase 3 clinical trial of elafibranor in PBC, which enrolled its first patient in September 2020. At the start of the trial, and considering the pandemic situation, we had estimated that enrollment in the ELATIVE study would take approximately 18 months and so far, we have been broadly in-line with this estimate. However, the recent rapid expansion of the highly contagious Omicron strain of COVID has created additional complications for us in enrolling patients and in clinical trial operations generally. The rate of infection, as well as the containment measures put in place to control its growth have led to patients postponing site visits or having to be re-screened because they had fallen outside the screening window. This recent worsening of the COVID pandemic has also created significant additional administrative backlogs at sites and regulatory agencies, due to the combination of continued high volume of trials and staffing shortages. This has disproportionately impacted regions where there were already significant delays, such as Latin America. Although we currently do not anticipate these recent complexities to substantially change the guidance related to availability of the ELATIVE top line results, we are currently assessing with our CRO the extent of impact on enrollment timelines. We will provide an update during our next webcast scheduled for April 7, 2022.

3 Revenues recognized under IFRS 15

2 Upcoming Financial Communications

The Company will release its full-year 2021 financial results on April 7, 2022. The 2021 Universal Registration Document, the 2021 Annual Financial Report (included in the 2021 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2022.

On March 1, 2022 Forma Therapeutics Holdings, Inc.(Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the year ended December 31, 2021 (Press release, Forma Therapeutics, MAR 1, 2022, View Source [SID1234609220]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"2021 was a year of continued growth for Forma as we completed our comprehensive Phase I etavopivat trial, and further advanced the importance of assessing red blood cell health," said Frank Lee, president and chief executive officer of Forma. "2022 represents a year of expansion for Forma, expanding the breadth of the etavopivat development plan into new indications, proof of concept readout for FT-7051 in metastatic prostate cancer, and a new development candidate emerging from our research pipeline."

Key Business and Clinical Highlights

Pyruvate Kinase-R (PKR) Program in Sickle Cell Disease (SCD):

•Comprehensive etavopivat Phase I trial completed. Open label extension (OLE) results for 15 patients administered etavopivat 400 mg once daily for up to 12 weeks with a data cutoff as of November 23, 2021 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021. Improvements were observed in measures of hematologic and hemolytic response, and biomarkers of red blood cell (RBC) health, including oxygenation and deformability, as well as systemic biomarkers of SCD. Etavopivat administered for up to 12 weeks reduced anemia by significantly raising and sustaining hemoglobin levels and also significantly increased the lifespan of RBCs with decreased hemolysis. In addition, an analysis of all patients in the 12-week open label cohort showed a decreasing trend in vaso-occlusive crises (VOCs) requiring hospitalization when compared to the rate 12 months prior to trial entry. Etavopivat was well tolerated in the trial and safety was consistent with underlying SCD.
CBP/p300 Program in Metastatic Castrate Resistant Prostate Cancer (mCRPC):

•FT-7051 well tolerated with signs of clinical activity in initial Phase I clinical trial results. Initial results from eight men in the trial were presented at the NCI/AACR/EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2021. Pharmacokinetic (PK) analysis of FT-7051 documented rapid absorption, with drug concentrations that approached the predicted efficacious dose based on estimates from preclinical models. In addition, skin biopsies demonstrated a reduction in a marker of activity in the CBP/p300 pathway. The majority of treatment-emergent adverse events (TEAEs) observed were mild or moderate with no events leading to treatment discontinuation. The first evaluable patient completing 12 weeks of treatment demonstrated a >80% decline in prostate-specific antigen (PSA80) from baseline at 16 weeks with stable disease.
IDH1 Program in Acute Myeloid Leukemia (AML)

•First Phase II results of olutasidenib used in combination with a chemotherapy were presented at the ASH (Free ASH Whitepaper) annual meeting in December 2021. The trial included patients who had not yet received therapy and were candidates for azacitidine as a first-line treatment, and also patients with relapsed/refractory (R/R) AML that had prior therapy with a hypomethylating agent (HMA) or an IDH1 inhibitor. The results support the potential of olutasidenib as the basis of combination therapy in patients with AML who have not achieved a durable response from prior therapy. Olutasidenib was well tolerated in the trial in combination with azacitidine and the combination had a safety profile largely consistent with that of olutasidenib alone. Forma is progressing a new drug application (NDA) for the treatment of R/R AML.
Corporate

•Appointed Ifeyinwa (Ify) Osunkwo, MD, MPH, as the company’s inaugural chief patient officer and senior vice president. Dr. Osunkwo will be responsible for realizing Forma’s vision to transform the lives of patients, including improving access and care through partnerships with global patient and community stakeholders.
•Launched formabridge and grants program. Through formabridge grants, Forma has committed $1 million in funding for promising and innovative initiatives that address unmet needs in transition from pediatric to adult care in SCD.
•Upcoming investor conference participation. Forma will participate in the Oppenheimer Healthcare Conference taking place March 15-16, 2022. The presentation webcast will be available in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.
•Virtual research and development (R&D) review to be held in May, 2022. The company will provide an overview of its internal research pipeline strategy and review compounds in clinical and pre-clinical development. The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.
Upcoming Milestones

•Patient enrollment in global pivotal Phase II/III trial of etavopivat for the treatment of SCD, the Hibiscus Study. The first interim analysis (IA1) in the Hibiscus Study is expected to be reached by the end of 2022, with dose selection for the Phase III portion of the trial.
•Etavopivat development plans expanding. Forma began a Phase II trial in transfusion dependent SCD and both transfusion dependent and non-transfusion dependent thalassemia in late 2021, with initial results expected in late 2022. During 2022, Forma plans to begin clinical trials in pediatric SCD and low risk myelodysplastic syndrome (MDS).

•Additional FT-7051 clinical trial results in mCRPC. Men with mCRPC continue to be enrolled in the dose escalation portion of the Phase I trial. Forma plans to present updated results from the trial in mid-2022.
•Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials or and the ability to access sites participating in clinical trials.
Financial Results

•Cash Position: Cash, cash equivalents and marketable securities were $490.3 million as of December 31, 2021, as compared to $645.6 million as of December 31, 2020. Current cash runway is projected through the third quarter of 2024.
•R&D Expenses: R&D expenses were $37.0 million and $125.7 million for the quarter and year ended December 31, 2021, compared to $24.9 million and $93.4 million for the quarter and year ended December 31, 2020. The increase was primarily attributable to the conduct of etavopivat Phase II/III and Phase I trials in SCD patients, as well as start-up costs related to the thalassemia trial, manufacturing activities, and increases in research and development staff, equity-based compensation, and investment in preclinical programs.
•General and Administrative (G&A) Expenses: G&A expenses were $13.2 million and $48.3 million for the quarter and year ended December 31, 2021, compared to $7.9 million and $30.8 million for the quarter and year ended December 31, 2020. The increase was primarily attributable to increases in equity-based compensation, personnel-related costs related to executive and staff hiring, professional fees, and insurance related expenses.
•Net Loss: Net loss was $50.1 million and $173.0 million for the quarter and year ended December 31, 2021, compared to net loss of $28.6 million and $70.4 million for the quarter and year ended December 31, 2020.

Forma will conduct a conference call and webcast March 1, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss year end 2021 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 3322907.

The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.

On March 1, 2022 TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) and Catalent reported their collaboration agreement focused on the generation, testing and manufacture of dry powder formulations for a range of biotherapeutics through the application of TFF Pharmaceuticals’ patented Thin Film Freezing (TFF) technology (Press release, Catalent, MAR 1, 2022, https://www.catalent.com/catalent-news/tff-pharmaceuticals-and-catalent-announce-new-inhalation-dry-powder-development-and-manufacturing-agreement/ [SID1234609219]). Under the agreement, Catalent will provide its scale-up expertise and manufacturing capabilities to TFF Pharmaceuticals as its preferred development and manufacturing partner, and Catalent will be able to offer its customers access to the innovative TFF technology, which has the potential to increase the adoption of the pulmonary route for the systemic delivery of biotherapeutics.

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"Catalent is widely known as a global leader in enabling pharmaceutical development and manufacturing and has distinguished itself by demonstrating cutting-edge expertise across multiple modalities and innovative projects. We are therefore delighted to significantly expand our collaboration with the Catalent team," stated Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. "This strategic collaboration significantly expands our access to manufacturing capabilities and provides scalability for our technology, while simultaneously affording us the opportunity to build our portfolio of technology licensing partnerships."

Jonathan Arnold, President, Oral and Specialty Delivery at Catalent added, "Catalent is pleased to leverage its extensive expertise in the development and CGMP manufacture of dry powders in order to potentially bring TFF Pharmaceuticals’ unique and differentiated technology to scale."

Thin Film Freezing may potentially be used to generate dry powder formulations for inhalation, and it complements Catalent’s existing capabilities in spray drying for the development of inhalable drugs established by its 2021 acquisition of the manufacturing and packaging operations of Acorda Therapeutics in Boston, Massachusetts.

On March 1, 2022 Alkermes plc (Nasdaq: ALKS) reported plans to present data related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer, taking place March 18-21, 2022 (Press release, Alkermes, MAR 1, 2022, View Source [SID1234609218]). New data in patients with platinum-resistant ovarian cancer from ARTISTRY-1, a phase 1/2 study evaluating the safety, tolerability and efficacy of intravenously administered (IV) nemvaleukin as a monotherapy and in combination with pembrolizumab (KEYTRUDA), will be presented in an oral plenary session. In addition, a trial-in-progress poster from the ongoing ARTISTRY-7 global phase 3 study will be presented. ARTISTRY-7 is evaluating the anti-tumor activity and safety of IV nemvaleukin in combination with pembrolizumab compared to investigator’s choice chemotherapy, in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

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Details of the presentations are as follows:

Oral Presentation
Title: Clinical Outcomes of Ovarian Cancer Patients Treated with the Novel Engineered Cytokine Nemvaleukin Alfa in Combination with the PD-1 Inhibitor Pembrolizumab: Recent Data from ARTISTRY-1
Presenter: Ira Winer, M.D., Ph.D., Associate Professor, Division of Gynecologic Oncology, Wayne State University and Barbara Ann Karmanos Cancer Institute
Presentation Date/Time: The oral presentation is scheduled to occur on March 19, 2022 during the Scientific Plenary III session (11:00 a.m. – 12:15 p.m. MST).

Poster Presentation
Poster Number: 326
Title: ARTISTRY-7: A Phase 3, Multicenter Study of Nemvaleukin Alfa, a Novel Engineered Cytokine, in Combination With Pembrolizumab Versus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Presenter: Thomas J. Herzog, M.D., Professor of Obstetrics & Gynecology, Deputy Director, University of Cincinnati Cancer Institute
Presentation Date: The poster will be available for on-site and virtual viewing beginning March 18, 2022.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

On March 1, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2021, and recent company developments, along with a business outlook for 2022 (Press release, TG Therapeutics, MAR 1, 2022, View Source [SID1234609214]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "While we’ve faced numerous challenges over the last several months, we continued to progress our programs forward toward commercialization. With both MS and CLL BLA/sNDA submissions pending at the FDA, we continue to see 2022 as potentially the most transformative year in the Company’s history." Mr. Weiss continued, "We are looking forward to the upcoming ODAC meeting where we can showcase the clinical profile of UKONIQ monotherapy in its approved indications and in combination with ublituximab in CLL. We are also very excited about the evolving profile of ublituximab and its potential role in the treatment of RMS. We continue to receive positive feedback from the MS community about the safety, efficacy and one hour infusion offered by ublituximab."

2021 Highlights & Recent Developments

Ublituximab in Multiple Sclerosis

U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for ublituximab, as a treatment for patients with relapsing forms of multiple sclerosis (RMS) and set a Prescription Drug User Fee Act (PDUFA) goal date of September 28, 2022.
Presented positive results, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 2021 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and at the 2022 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum. As previously reported, both trials met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared to teriflunomide in patients with RMS. Additional secondary, tertiary and post-hoc sensitivity analyses were also presented, including T1 and T2 lesions, no evidence of disease activity (NEDA), brain volume, multiple sclerosis functional composite (MSFC) score, neutralizing antibodies and antidrug antibodies, and pharmacodynamics of B-cell depletion.
Ublituximab plus UKONIQ (umbralisib) (U2) in Chronic Lymphocytic Leukemia

FDA accepted a BLA for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ, both submissions requesting approval of U2 as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These applications were based on results from the UNITY-CLL Phase 3 trial, which included both treatment-naïve and relapsed or refractory (R/R) CLL patients. FDA notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC), in connection with its review of the pending BLA/sNDA for U2, in the March/April 2022 timeframe. Due to the pending ODAC meeting, the Company does not expect a decision on the BLA/sNDA by the current PDUFA goal date of March 25, 2022.
Related to the concerns giving rise to the ODAC, FDA imposed a partial clinical hold on studies of U2 and its components in CLL and NHL.
UKONIQ in Relapsed or Refractory Marginal Zone Lymphoma & Follicular Lymphoma

Launched UKONIQ in the U.S. for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
Generated $6.5 million in total net UKONIQ revenue from launch through the end of Q4 2021, approximately ten months.
Achieved broad U.S. payor coverage for more than 95% of Medicare and commercial lives and inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for MZL and FL.
TG-1701 in B-cell Malignancies

Presented updated data on TG-1701, our investigational bruton tyrosine kinase (BTK) inhibitor, as a monotherapy and in combination with U2 in patients with B-cell malignancies at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
Strengthened Cash Position

Ended the year with more than $350 million in cash, cash equivalents and investment securities.
Key Objectives for 2022

Obtain a favorable outcome at the upcoming ODAC meeting.
Obtain FDA approval of U2 in CLL and SLL.
Obtain FDA approval of ublituximab in RMS.
Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), our PDL1 inhibitor, TG-1701, our BTK inhibitor and TG-1801 our CD47/CD19 bispecific antibody.
Financial Results for the Fourth Quarter and Full Year 2021

Product Revenue, net: Product revenue, net was approximately $2.3 million and $6.5 million for the three and twelve months ended December 31, 2021. Net product revenues represent U.S. sales from our sole commercial product, UKONIQ, which received accelerated approval from the FDA on February 5, 2021.

R&D Expenses: Total research and development (R&D) expense was $62.6 million and $222.6 million for the three and twelve months ended December 31, 2021, compared to $43.0 million and $165.9 million for the three and twelve months ended December 31, 2020. The increase was due primarily to an increase in manufacturing expenses, as well as an increase in non-cash compensation R&D expense during the twelve months ended December 31, 2021 over the comparable period in 2020.
SG&A Expenses: Total selling, general and administrative (SG&A) expense was $32.4 million and $128.1 million for the three and twelve months ended December 31, 2021, and $43.9 million and $107.9 million for the three and twelve months ended December 31, 2020. The increase during the twelve months ended December 31, 2021 was primarily attributable to increased personnel and other selling, general and administrative costs associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL/SLL and ublituximab in RMS. The decrease during the three months ended December 31, 2021 was primarily related to non-cash compensation expense related to milestone-based vesting of restricted stock grants during the comparable period in 2020.
Net Loss: Net loss was $93.3 million and $348.1 million for the three and twelve months ended December 31, 2021, compared to $88.2 million and $279.4 million for the three and twelve months ended December 31, 2020. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2021 was approximately $79.0 million and $286.8 million, compared to a net loss of $54.7 million and $199.1 million for the three and twelve months ended December 31, 2020.
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $350.3 million as of December 31, 2021, which the Company believes will be sufficient to fund the Company’s planned operations into 2023.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, March 1, 2022, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2021 financial results and provide a business outlook for 2022.

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. 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.