TG Therapeutics Provides Business Update and Reports First Quarter 2020 Financial Results
May 11, 2020
Recent Developments and Highlights
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) and will be stopped early for superior efficacy. Regulatory submission and full data presentation targeted by year-end 2020.
Marginal Zone Lymphoma & Follicular Lymphoma:
January 2020, received guidance from the U.S. Food and Drug Administration(FDA) allowing submission of a single New Drug Application (NDA) for marginal zone lymphoma (MZL) and follicular lymphoma (FL) indications. A rolling NDA submission for umbralisib to treat adult patients with previously treated MZL and FL was initiated, with completion of submission targeted in the first half of 2020.
March 2020, received orphan drug designation for umbralisib from the FDA for the treatment of FL.
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.
- Awaiting topline data from the Company’s Phase 3 ULTIMATE I & II trials evaluating ublituximab in patients with RMS, targeted in second half 2020.
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.
Bolstered Balance Sheet:
May 2020, strengthened balance sheet with more than $75 millionin gross proceeds through the Company’s At-the-Market (ATM) facility, $40 million of which came from a longtime shareholder.
Key Objectives for 2020
- 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.
- Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL umbralisib monotherapy cohorts of the UNITY-NHL trial at a major medical meeting, by year-end 2020.
- 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), by year end 2020.
- Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.
Financial Results for the Three Months Ended
- R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was
$34.0 millionfor the three months ended March 31, 2020, compared to $30.9 millionfor the three months ended March 31, 2019. The modest increase in R&D expense is primarily attributable to costs associated with the preparation of the Company’s NDA filing for umbralisib in MZL and FL. We expect our R&D expenses to decrease during 2020 as costs associated with our main pivotal clinical trials continue to decline over the remainder of the year, 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
$5.2 millionfor the three months ended March 31, 2020, as compared to $1.9 millionfor the three months ended March 31, 2019. The increase in other G&A expenses is primarily due to the build out of our commercial team and infrastructure in anticipation of the potential commercialization of umbralisib and ublituximab. We expect G&A expenses to increase modestly during the remainder of 2020.
- Net Loss: Net loss was
$51.1 millionfor the three months ended March 31, 2020, compared to a net loss of $35.2 millionfor the three months ended March 31, 2019. Excluding non-cash compensation, the net loss for the three months ended March 31, 2020was approximately $40.0 million, compared to a net loss of $33.3 millionfor the three months ended March 31, 2019.
- Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were
$78.3 millionas of March 31, 2020. Pro forma cash, cash equivalents and investment securities as of March 31, 2020are approximately $154.3 million, after giving effect to $76.0 millionof net proceeds from the utilization of the Company's ATM sales facility during the second quarter of 2020 at an average price of $17.07. The Company believes its cash, cash equivalents and investment securities on hand as of March 31, 2020, inclusive of the proceeds raised from the ATM facility, as well as future availability under the Company’s debt and ATM facility, will be sufficient to fund the Company's planned operations through the end of 2021.
This press release includes forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the
Senior Vice President,
Selected Condensed Consolidated Financial Data
Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
|Three Months Ended|
|Costs and expenses:|
|Research and development|
|Other research and development||34,043||30,896|
|Total research and development||36,022||32,385|
|General and administrative|
|Other general and administrative||5,172||1,949|
|Total general and administrative||14,261||2,342|
|Total operating expenses||50,283||34,727|
|Other (income) expense:|
|Total other (income) expense||871||467|
|Consolidated net loss||$||(51,116||)||$||(35,156||)|
|Net income (loss) per common share:|
|Basic and diluted||$||(0.48||)||$||(0.43||)|
|Weighted average shares of common stock outstanding:|
|Basic and diluted||105,461,892||81,174,301|
Condensed Balance Sheet Information (in thousands):
|Cash, cash equivalents and investment securities||$||78,335||$||140,435|
|Total (deficit) equity||(1,353||)||38,615|
* Condensed from audited financial statements
Source: TG Therapeutics, Inc.