TG Therapeutics, Inc. Provides Business Update and Reports Third Quarter 2017 Financial Results
Third Quarter and Recent Highlights
- ASH 2017: The
Company looks forward to the upcoming
American Society of Hematology(ASH) Annual Meeting where data presentations will include three clinical poster presentations and three pre-clinical poster presentations.
- TG-1101 Data at ECTRIMS: Updated results from the ongoing Phase 2 Study of TG-1101 in patients with Multiple Sclerosis were presented at the 7th Joint ECTRIMS-ACTRIMS Meeting demonstrating robust activity on B-cell depletion, reduction of T1 Gd enhancing lesions, and positive effects on disability measurements.
- UNITY-CLL Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in October, which should allow for top-line data on Overall Response Rate (ORR) in Q2 2018.
- GENUINE Update: The Company met with the
FDAand confirmed that accelerated approval based on the ORR results from GENUINE would be a review issue and that the potential may exist for full approval based on the PFS results from the GENUINE study.
- TGR-1202 Grant: TGR-1202 (umbralisib) was selected for a grant by the
National Multiple Sclerosis Societyto support the development of TGR-1202 as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
- Anti-PD-L1 Entered the Clinic: The Company's anti-PD-L1 monoclonal antibody commenced clinical development, with the first patient being dosed in a Phase I clinical trial.
- ULTIMATE Phase 3 Trials in MS: Received a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and II studies in relapsing forms of multiple sclerosis and commenced enrollment into the global studies.
- UNITY-NHL: Announced successful outcome from the first pre-planned interim analysis by independent DSMB of the DLBCL cohort in the UNITY-NHL Phase 2b trial, where based on pre-set hurdles of ORR, the DSMB recommended continued enrollment in the TG-1101 plus TGR-1202 combination arm (also referred to as the U2 combination) and replacement of the single agent TGR-1202 arm with U2 plus bendamustine.
Financial Results for the Third Quarter 2017
- Cash Position: Cash, cash equivalents, investment securities, and interest receivable were
$91.8 millionas of September 30, 2017, as compared to $86.5 millionat June 30, 2017.
- R&D Expenses:
Research and development (R&D) expenses were
$27.1 millionand $76.5 millionfor the three and nine months ended September 30, 2017, respectively, compared to $21.8 millionand $46.9 millionfor the three and nine months ended September 30, 2016. Included in research and development expense for the three and nine months ended September 30, 2017was $7.1 millionand $20.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and nine months ended September 30, 2017, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.
- G&A Expenses:
General and administrative (G&A) expenses were
$4.5 millionand $11.3 millionfor the three and nine months ended September 30, 2017, respectively, as compared to $3.2 millionand $8.1 millionfor the three and nine months ended September 30, 2016. The increase in G&A expenses for the nine months ended September 30, 2017relates primarily to non-cash compensation expenses related to equity incentive grants recognized during 2017. We expect G&A expenses to remain relatively constant through the remainder of 2017.
- Net Loss: Net loss was
$31.5 millionand $87.6 millionfor the three and nine months ended September 30, 2017, respectively, compared to a net loss of $24.8 millionand $54.6 millionfor the three and nine months ended September 30, 2016, respectively.
- Financial Guidance: The Company believes its cash and cash equivalents will be sufficient to fund the Company's planned operations through 2018.
Conference Call Information
The Company will host an investor conference call today,
In order to participate in the conference call, please call 1-877-407-8029 (
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the
Vice President, Investor Relations
|Selected Consolidated Financial Data|
|Statements of Operations Information (Unaudited):|
|Three months ended ||Nine months ended |
|Costs and expenses:|
|Research and development:|
|Other research and development||25,334,762||20,878,108||71,150,033||45,075,097|
|Total research and development||27,149,050||21,797,756||76,536,742||46,948,827|
|General and administrative:|
|Other general and administrative||1,398,438||1,251,421||4,265,967||3,798,859|
|Total general and administrative||4,474,273||3,165,811||11,254,564||8,106,529|
|Total costs and expenses||31,623,323||24,963,567||87,791,306||55,055,356|
|Other (income) expense:|
|Total other income||(49,575||)||(94,444||)||(60,775||)||(362,319||)|
|Basic and diluted net loss per common share||$||(0.48||)||$||(0.50||)||$||(1.45||)||$||(1.11||)|
|Weighted average shares used in computing basic and diluted net loss per common share||65,079,128||49,203,277||60,552,084||48,961,582|
Condensed Balance Sheet Information:
|Cash, cash equivalents, investment securities and interest receivable||$||91,842,167||$||44,968,992|
* Condensed from audited financial statements.
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