TG Therapeutics Provides Business Update and Reports Second Quarter 2020 Financial Results
Aug 10, 2020
Recent Developments and Highlights
- Marginal Zone Lymphoma & Follicular Lymphoma:
June 2020, completed rolling submission of New Drug Application (NDA) to the U.S. Food and Drug Administration(FDA) for umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).
- Chronic Lymphocytic Leukemia:
May 2020, reported positive topline results from the Company’s UNITY-CLL Phase 3 trial evaluating U2 (the combination of umbralisib and ublituximab) in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of improved progression-free survival (PFS) (p<.0001), as determined by an Independent Review Committee (IRC).
May 2020, reported final results from the GENUINE Phase 3 study evaluating the combination of ublituximab plus ibrutinib compared to ibrutinib alone in patients with relapsed/refractory CLL with high-risk cytogenetics. Results indicated the addition of ublituximab to ibrutinib as compared to ibrutinib alone improved PFS, overall response rate, complete response rate and the number of patients with undetectable minimal residual disease.
- Multiple Sclerosis:
May 2020, announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS) in the Multiple Sclerosis Journal.
- Bolstered Balance Sheet:
May 2020, strengthened balance sheet with more than $240 millionin gross proceeds through a public offering and the Company’s At-the-Market (ATM) facility.
July 2020, published preclinical data describing the unique immunomodulatory effects of umbralisib, in Blood Advances, a Journal of the American Society of Hematology.
- Board of Directors & Management:
May 2020, appointed Sagar Lonial, MD, FACP, Professor and Chair of the Department of Hematology and Medical Oncologyat the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University, to the Company’s Board of Directors.
May 2020, strengthened executive team with the addition of Owen A. O’Connor, MD, PhD as Chief Scientific Officer. Dr. O’Connor most recently served as a Professor of Medicine and Experimental Therapeutics, the Director of the Center for Lymphoid Malignancies, and Co-Program Director of the Lymphoid Development and Malignancy Program in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.
Key Objectives for Remainder of 2020 and Early 2021
- Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis.
- Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at a major medical meeting.
- Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
- Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.
Financial Results for the Three and Six Months Ended
- R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was
$34.9 millionand $68.9 millionfor the three and six months ended June 30, 2020, respectively, compared to $31.4 millionand $62.3 millionfor the three and six months ended June 30, 2019, respectively. The modest increase in R&D expense during the three and six month periods of 2020 is primarily attributable to our ongoing clinical development programs as well as preparations for regulatory filings and potential commercialization. We expect our R&D expenses to decrease during the remainder of 2020 as costs associated with our main pivotal clinical trials continue to decline, partially offset by expenses associated with the expected NDA/BLA filing for U2 in CLL.
- G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was
$8.6 millionand $13.8 millionfor the three and six months ended June 30 2020, respectively, as compared to $2.3 millionand $4.3 millionfor the three and six months ended June 30, 2019, respectively. The increase in other G&A expenses is primarily due to increased personnel and other general and administrative costs, associated with preparations for a potential commercial launch. We expect G&A expenses to increase modestly during the remainder of 2020 in preparation for potential launch.
- Net Loss: Net loss was
$52.9 millionand $104.0 millionfor the three and six months ended June 30, 2020, respectively, compared to a net loss of $36.2 millionand $71.4 millionfor the three and six months ended June 30, 2019, respectively. Excluding non-cash compensation, the net loss for the three and six months ended June 30, 2020was approximately $45.5 millionand $85.6 million, respectively, compared to a net loss of $34.5 millionand $67.7 millionfor the three and six months ended June 30, 2019, respectively.
- Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were
$275.6 millionas of June 30, 2020. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2020, as well as future availability under the Company’s debt and ATM facility, will be sufficient to fund the Company's planned operations through the end of 2021.
This press release includes forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the
Senior Vice President,
Selected Condensed Consolidated Financial Data
Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
Three months ended
|Six months ended
|Costs and expenses:|
|Research and development:|
|Noncash stock expense associated with in-licensing agreements||--||100||--||100|
|Other research and development||34,896||31,414||68,939||62,310|
|Total research and development||36,449||32,866||72,471||65,251|
|General and administrative:|
|Other general and administrative||8,617||2,311||13,789||4,260|
|Total general and administrative||14,434||2,716||28,695||5,057|
|Total costs and expenses||50,883||35,582||101,166||70,308|
|Other expense (income):|
|Total other expense (income), net||2,039||669||2,910||1,136|
|Basic and diluted net loss per common share|
|Weighted average shares used in computing basic and diluted net loss per common share||112,353,414||86,800,017||108,926,690||84,002,700|
Condensed Balance Sheet Information (in thousands):
|Cash, cash equivalents and investment securities|
* Condensed from audited financial statements
Source: TG Therapeutics, Inc.