TG Therapeutics Provides Business Update and Reports First Quarter 2019 Financial Results
Recent Developments and Highlights
- Marginal Zone Lymphoma – Breakthrough Therapy and Orphan Drug Designations: Received breakthrough therapy designation (BTD) and orphan drug designation for umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal and splenic MZL.
- Positive Results from MZL Cohort of UNITY-NHL Trial: Announced positive outcome from the MZL cohort of the UNITY-
NHLtrial, which met the primary endpoint of Overall Response Rate (ORR). Interim safety and efficacy data from this study were presented in an oral presentation at the American Association of Cancer Research(AACR) annual meeting in Atlanta.
- DSMB Updates: Meetings held by the independent Data Safety Monitoring Boards (DSMBs) for both the UNITY-CLL trial and the UNITY-
NHLtrial did not raise any safety concerns and recommended that both trials continue unmodified.
- TG-1801 (Anti-CD47/CD19): Commenced a Phase 1 first-in-human, dose-escalation study of TG-1801 in patients with relapsed or refractory B-cell lymphoma.
- Multiple Sclerosis Data: Presented long-term safety data from the open label extension (OLE) of the Phase 2 trial of ublituximab in multiple sclerosis, which demonstrated that ublituximab continues to be well tolerated.
Remaining 2019 Milestones
- Potential top-line progression free survival (PFS) results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with CLL
- Present final data from the MZL cohort of the UNITY-
NHLregistration directed trial evaluating umbralisib in MZL
- Potential UNITY-NHL NDA filing in MZL
- Present updated data from our pipeline products and combination studies at upcoming major medical conferences
Financial Results for the First Quarter 2019
- Cash Position: Cash, cash equivalents and investment securities were
$92.5 millionas of March 31, 2019. Pro-forma cash, cash equivalents and investment securities as of March 31, 2019(excluding our second quarter 2019 operations) are approximately $116.7 million, after giving effect to $24.2 millionof net proceeds from the utilization of the Company's at-the-market ("ATM") sales facility during the second quarter of 2019.
- R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was
$30.9 millionfor the three months ended March 31, 2019compared to $32.2 millionfor the three months ended March 31, 2018. Included in other research and development expense for the three months ended March 31, 2019was $13.8 millionof clinical trial expense and $6.4 millionof manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The current period decrease in Other R&D expenses is primarily due to full enrollment in our pivotal Phase III clinical development programs completed in the prior period. We expect the decrease in other R&D expenses to continue over the next several quarters.
- G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was
$1.9 millionfor the three months ended March 31, 2019as compared to $2.1 millionfor the three months ended March 31, 2018. Other G&A expenses for the three months ended March 31, 2019remained relatively flat compared to the first quarter of 2018, and we expect Other G&A expenses to increase modestly through the remainder of 2019.
- Net Loss: Net loss was
$35.2 millionfor the three months ended March 31, 2019, compared to a net loss of $41.5 millionfor the three months ended March 31, 2018. Excluding non-cash items, the net loss for the three months ended March 31, 2019was approximately $33.3 million.
- Financial Guidance: Net cash utilized for operating activities during the three months ended
March 31, 2019was approximately $33.5 million. The Company believes its cash, cash equivalents and investment securities on hand as of March 31, 2019, inclusive of the proceeds raised subsequent to the first quarter, will be sufficient to fund the Company's planned operations through mid-2020.
Conference Call Information
The Company will host a conference call today,
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 First Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. 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.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release may be 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 Consolidated Financial Data
Statements of Operations Information (in thousands, except share and per share amounts; unaudited):
|Three months ended March 31,|
|Costs and expenses:|
|Research and development:|
|Other research and development||30,896||32,159|
|Total research and development||32,385||35,018|
|General and administrative:|
|Other general and administrative||1,949||2,119|
|Total general and administrative||2,342||6,597|
|Total costs and expenses||34,727||41,615|
|Other (income) expense:|
|Other (income) expense||616||96|
|Total other income, net||467||(48||)|
|Basic and diluted net loss per common share||$||(0.43||)||$||(0.59||)|
|Weighted average shares used in computing basic and diluted net loss per common share||81,174,301||70,636,970|
Condensed Balance Sheet Information (in thousands):
|March 31, 2019|
|(Unaudited)||December 31, 2018*|
|Cash, cash equivalents and investment securities||$||92,474||$||68,900|
* Condensed from audited financial statements
Source: TG Therapeutics, Inc.