On August 10, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a late stage clinical biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, today reported financial results for the three and six months ended June 30, 2017 and key corporate highlights (Press release, Sophiris Bio, AUG 10, 2017, View Source [SID1234520160]).

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Key Corporate Highlights:

Phase 2b Localized Prostate Cancer Study Underway. On June 8, 2017, the Company announced that the first patient had been dosed in its Phase 2b study to evaluate the safety and tolerability of a single dose of topsalysin in focally treating men with clinically significant localized prostate cancer. Topsalysin (PRX302) is an innovative, first-in-class pore-forming protein engineered to be activated only in the presence of enzymatically-active PSA, which is only found within the prostate. This study is enrolling approximately 40 patients at clinical sites in the UK and US. The Company expects to receive the 24- week biopsy data for all patients from the first dose of topsalysin in the first quarter of 2018 assuming enrollment is completed as expected.

The Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with a targeted biopsy to occur 24 weeks following the second dose. The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018 assuming enrollment is completed as expected.

Added to Russell Microcap Index. In June 2017, the Company was added to the Russell Microcap Index. Russell indices are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.
Filing of New Form S-3. In anticipation of the expiration of the company’s existing Form S-3 shelf registration statement filed in September 2014, Sophiris will file a new Form S-3 today with the Securities and Exchange Commission to register securities which could be issued in the future.
"Topsalysin is a highly potent ablative agent, which we administer by an ultrasound-guided injection directly into a tumor, previously confirmed by biopsy. We are using state of the art commercially available software in order to increase the precision by which the physician administers topsalysin into the pre-identified tumor," said Randall E. Woods, president and CEO of Sophiris. "We are working toward completion of enrollment, and we would like to thank the investigators, study coordinators and patients for their participation in this exciting study."

Financial Results:

At June 30, 2017, the Company had cash, cash equivalents and securities available-for-sale of $24.0 million and working capital of $23.4 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

For the three months ended June 30, 2017

The Company reported net income of $0.6 million or $0.02 per share for the three months ended June 30, 2017 compared to a net loss of $4.1 million or ($0.21 per share) for the three months ended June 30, 2016. The net income for the three months ended June 30, 2017 was driven by a non-cash gain related to the revaluation of the Company’s warrant liability. See an additional discussion below related to this item.

Research and development expenses

Research and development expenses were $1.4 million for the three months ended June 30, 2017, compared to $1.0 million for the three months ended June 30, 2016. The increase in research and development costs are primarily attributable to increases in the costs associated with the Company’s Phase 2b clinical trial for the focal treatment of localized prostate cancer, costs associated with manufacturing activities for topsalysin and non-cash stock-based compensation expense. These increases are partially offset by decreases in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer and personnel related costs.

General and administrative expenses

General and administrative expenses were $1.4 million for the three months ended June 30, 2017 and 2016. General and administrative expense included non-cash stock-based compensation expense of $0.3 million for the three months ended June 30, 2017 as compared to $0.1 million for the three months ended June 30, 2016. This increase was offset by decreases for personnel related costs.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $3.3 million for the three months ended June 30, 2017 compared to a loss of $1.6 million for the three months ended June 30, 2016. Because these warrants may require us to pay the warrant holder cash under certain provisions of the warrant, we account for these warrants as a liability and we are required to calculate the fair value of these warrants each reporting date. This non-cash gain is associated with a reduction in the fair value of the Company’s warrant liability which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the six months ended June 30, 2017

The Company reported a net loss of $2.0 million or ($0.07 per share) for the six months ended June 30, 2017 compared to a net loss of $6.3 million or ($0.35 per share) for the six months ended June 30, 2016.

Research and development expenses

Research and development expenses were $2.6 million for the six months ended June 30, 2017 compared to $1.9 million for the six months ended June 30, 2016. The increase in research and development costs are primarily attributable to increases in the costs associated with the Company’s Phase 2b for the focal treatment of localized prostate cancer, costs associated with the manufacturing activities for topsalysin and the non-cash stock-based compensation expense. These increases are partially offset by decreases in costs associated with our completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer and personnel related costs.

General and administrative expenses

General and administrative expenses were $2.7 million for the six months ended June 30, 2017 compared to $2.5 million for the six months ended June 30, 2016. The increase is primarily due to an increase in professional services and non-cash stock-based compensation expense. These increases are partially offset by the decreases in personnel related costs, legal and closing costs which were expensed as they were allocated to the warrants issued in our completed financing during the six months ended June 30, 2016.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $3.2 million for the six months ended June 30, 2017 as compared to a loss of $1.6 million for the six months ended June 30, 2016. This non-cash gain is associated with a reduction in the fair value of our warrant liability.

On August 10, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported its financial and operational results for the second quarter ended June 30, 2017 (Press release, Sierra Oncology, AUG 10, 2017, View Source [SID1234520143]).

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"During the quarter, we reported encouraging initial progress from our novel synthetic lethality-oriented Phase 1 Monotherapy trial of SRA737, demonstrating that our Chk1 inhibitor was well-tolerated to date and that patients were now receiving doses of drug above the minimum concentration projected to be therapeutically active," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Following the clinical success of PARP inhibitors by several companies, enthusiasm has grown within the scientific and medical community for the potential to treat cancers by exploiting the DDR network, and there is increasing attention being placed on the limited number of novel DDR agents like ours that are currently in clinical trials. Our focus for the balance of 2017 is on driving patient enrollment into our two trials with the objective of providing a preliminary update from these studies in early 2018."

Highlights from the second quarter:
Sierra Oncology’s collaborator, The Institute of Cancer Research (ICR), reported preclinical synthetic lethality data for SRA737 at AACR (Free AACR Whitepaper) 2017, supporting the use of SRA737 in certain genetically defined tumors and in combination with chemotherapy.

Secured patents in the United States and Europe explicitly covering SRA737 and extending its protection out to 2033 in the United States before any patent term extensions.

Received regulatory clearance to enhance the two ongoing Phase 1 clinical trials for SRA737 to incorporate the prospective enrollment of patients with genetically-defined tumors (determined using Next-Generation Sequencing) that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

Presented these innovative clinical trial enhancements in two posters at the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting.

Reported encouraging initial progress from the ongoing Phase 1 SRA737 Monotherapy trial, including:

The Dose Escalation Phase of the trial, which employs an accelerated titration design, had rapidly advanced through several 100% dose escalations.

SRA737 had been well-tolerated and the maximum tolerated dose (MTD) had not been reached. No Grade 2 or higher SRA737-related Adverse Events had been reported.

Pharmacokinetic (PK) parameters for SRA737 had been generally linear across the dose range tested.

Several cohorts had surpassed the proposed minimum efficacious plasma concentration for SRA737 based on preclinical modelling. This enabled the commencement of the parallel Cohort Expansion Phase of the trial, which is enrolling prospectively-selected genetically-defined patients into five indication-specific cohort expansions at potentially active dose levels.

Transitioned the Phase 1 Chemotherapy Combination trial to Stage 2, which is evaluating SRA737 in combination with low-dose gemcitabine. Once an MTD and dosing schedule have been determined, the study will also evaluate the preliminary efficacy of the combination in an indication-specific cohort of prospectively-selected, genetically-defined subjects.

Second Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $7.2 million for the three months ended June 30, 2017, compared to $9.1 million for the three months ended June 30, 2016. Research and development expenses were $15.2 million for the six months ended June 30, 2017, compared to $15.8 million for the six months ended June 30, 2016. The decreases were due to a $2.8 million restructuring charge related to close-out expenses for PNT2258 and a $0.9 million upfront license payment for the exclusive license of SRA141 that were incurred in the second quarter of 2016. There was also a decrease in clinical trial costs as compared to the prior period, due to the discontinuation of PNT2258 clinical trials. These decreased costs were partially offset by an increase in third-party manufacturing and research costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $1.0 million and $2.0 million for the three and six months ended June 30, 2017, and of $0.8 million and $1.8 million for the three and six months ended June 30, 2016.

General and administrative expenses were $3.3 million for the three months ended June 30, 2017, compared to $3.8 million for the three months ended June 30, 2016. General and administrative expenses were $6.4 million for the six months ended June 30, 2017, compared to $7.8 million for the six months ended June 30, 2016. The decreases were due to a $0.3 million restructuring charge incurred in the second quarter of 2016 and a decrease in business development expenses. General and administrative expenses included non-cash stock-based compensation of $0.5 million and $1.0 million for the three and six months ended June 30, 2017, and $0.5 million and $0.9 million for the three and six months ended June 30, 2016.

For the three months ended June 30, 2017, Sierra incurred a net loss of $10.3 million compared to a net loss of $12.9 million for the three months ended June 30, 2016. For the six months ended June 30, 2017, Sierra incurred a net loss of $21.4 million compared to a net loss of $23.4 million for the six months ended June 30, 2016.

Cash and cash equivalents totaled $116.7 million as of June 30, 2017, compared to $125.0 million as of March 31, 2017, and $109.0 million as of December 31, 2016. The company raised net proceeds of $27.4 million in February 2017 from an underwritten public offering of common stock. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019.

At June 30, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,716,043 shares of common stock issued and outstanding.

On August 10, 2017 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, reported its financial results for the second quarter ended June 30, 2017, and provided a business update (Filing, Q2, RXi Pharmaceuticals, 2017, AUG 10, 2017, View Source [SID1234520141]).

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"During the first half of 2017, the Company focused on the main elements that can drive progress and value for RXi," said Dr. Geert Cauwenbergh, President, and CEO of RXi Pharmaceuticals. "These key elements include:
First, we are pleased that NASDAQ has granted the Company a six-month extension to regain listing compliance with the $1.00 bid price requirement.

Second, all of our ongoing human clinical programs are on schedule. Therefore, the Company remains on track with its 2017 corporate goals to report top-line data on most studies before the end of this year.

Third, several in vitro studies and animal studies using sd-rxRNA checkpoint inhibitors for immuno-oncology and cell therapy are ongoing and expected to produce reportable results in the second half of this year.

Finally, RXi maintained a conservative spend rate in line with its projected budget. Careful allocation of funds is focused on programs that we believe will maximize value creation. To continue the development of new drugs that are filling major gaps in the treatment of life threatening and debilitating diseases, we have put an equity line in place with Lincoln Park Capital Fund, LLC, a leading biotech investment fund. This funding mechanism extends our financial runway beyond Q2 2018. Importantly, the Company is in complete control of if, and when, it may choose to access the equity line."

The Company will host a conference call today at 4:30 p.m. EDT to discuss financial results and provide an update on the Company. The webcast link is available under the "Investors – Events and Presentations" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5983. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Second Quarter 2017 Financial Highlights
Cash Position
At June 30, 2017, the Company had cash of $7.7 million, compared with $12.9 million at December 31, 2016.

On August 8, 2017, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $15 million in shares of the Company’s common stock over the 30-month term of the agreement. We expect to use proceeds from the purchase agreement for general corporate purposes, including but not limited to the advancement of our immunotherapy program, our clinical trials, and general and administrative expenses.

The Company believes that its existing cash and the potential proceeds available under our equity facility with LPC should be sufficient to fund the Company’s operations for at least the next twelve months.

Research and Development Expenses
Research and development expenses for the quarter ended June 30, 2017 were $1.3 million, as compared with $1.3 million for the quarter ended June 30, 2016. While overall research and development expenses were consistent quarter over quarter, there were increases in research and development expenses due to a ramp-up in enrollment related to the second cohort in the Company’s Phase 2 clinical trial for Samcyprone, which was offset by a decrease in stock-based compensation expense.

Acquired In-process Research and Development Expense
The Company had acquired in-process research and development expense of $0.9 million for the quarter ended June 30, 2017. There was no such expense for the three months ended June 30, 2016. In January 2017, the Company acquired all of the issued and outstanding capital stock of MirImmune Inc., a privately-held biotechnology company that was engaged in the development of cancer immunotherapies. In exchange, the Company issued shares of common stock and Series C convertible preferred stock, which were subject to a 3% holdback for any purchase price adjustments. The acquired in-process research and development expense recorded during the three months ended June 30, 2017 related to the value of the securities subject to the holdback that was released on April 12, 2017.

General and Administrative Expenses
General and administrative expenses for the quarter ended June 30, 2017 were $1.1 million, as compared with $0.9 million for the quarter ended June 30, 2016. The increase in general and administrative expenses was due to increases in employee headcount in connection with the acquisition of MirImmune and legal and accounting fees. These increases were offset by a decrease in stock-based compensation expense.

Net Loss
Net loss for the three months ended June 30, 2017 was $2.5 million, compared with $2.2 million for the three months ended June 30, 2016. The increase in net loss was primarily driven by the changes in acquired in-process research and development expense and general and administrative expenses, as discussed above.

Nasdaq Compliance
On August 2, 2017, the NASDAQ Stock Market provided written notice and granted the Company an additional 180 calendar days to regain compliance with the minimum bid price requirements set forth in the NASDAQ listing rules. As a result of this extension, the Company has until January 29, 2018 to regain compliance by maintaining a closing bid price of at least $1.00 for 10 consecutive business days. The NASDAQ written notice has no effect on the listing of the Company’s common stock at this time.

Select Second Quarter 2017 and Recent Corporate Highlights
Select Business and Corporate Highlights

Board of Directors
The Company announced the appointment of Dr. Jonathan Freeman as an independent director to the Company’s Board of Directors. Dr. Freeman is a member of the Company’s Audit and Nominating & Governance Committees.

Dr. Jonathan Freeman currently serves as the Chief Business Officer at Vedanta Biosciences, a privately-held company developing a class of drugs that work by modulating the human microbiome, with an initial emphasis on autoimmune and inflammatory diseases. Previously, Dr. Freeman was Senior Vice President, Head of Strategy Development and Portfolio Management at Merck KGaA. Before that role, he was the Head of Global Business Development and Licensing at Merck executing more than 30 transactions and structured financings. Prior to his roles at Merck, Jonathan served in senior positions at Baxter and Serono, in M&A and, Corporate and Business Development, respectively. Jonathan holds a First Class Honours in Biochemistry and an MA from Cambridge University, UK, a Ph.D. in cancer research from the Imperial Cancer Research Fund (now CRUK), and an MBA with a finance major from Webster University, St. Louis. He held various post-doctoral positions at the Swiss Institute for Cancer Research (ISREC), and the Geneva Medical School (CMU).

Development Programs
Immuno-oncology
The Company’s ongoing program to develop cell-based immunotherapies to treat cancer is based on its proprietary self-delivering RNAi (sd-rxRNA) technology platform. Recently, the Company announced that it extended a preclinical research collaboration with PCI Biotech to the field of immuno-oncology. This new preclinical research collaboration agreement reflects PCI Biotech’s focus on oncology and the expansion of RXi’s development pipeline to include immuno-oncology. In brief, the collaboration will evaluate technology compatibility and synergy based on in vivo studies. The companies will evaluate results achieved from this research collaboration and then explore the potential for a further partnership.

RXi has also selected two sd-rxRNA compounds from its immuno-oncology pipeline for preclinical development. For oncology treatments based on adoptive cell transfer (ACT), compounds RXI-762 and RXI-804 suppress the expression of immune checkpoint proteins PD-1 and TIGIT respectively, which can result in an improved efficacy to the targeted tumors. This decision triggered the selection of a manufacturing facility to initiate production of cGMP grade material, initially for the first of these two compounds (RXI-762). The latter also supports moving RXI-762 into clinical development as early as 2018 as part of an ACT therapy.

RXI-109-1402 – Hypertrophic Scarring
The Company’s ongoing Phase 2 clinical trial, RXI-109-1402, is being conducted to evaluate RXI-109, a sd-rxRNA compound targeting connective tissue growth factor (CTGF), a key regulator of scar formation. This open-label, multi-center, study is designed to evaluate the effectiveness and safety of RXI-109 to reduce scar formation in healthy volunteers post scar revision surgery. The Company expects to share final study outcomes before the end of this year.

RXI-109-1501 – Retinal Scarring in Advanced Age-related Macular Degeneration (AMD)
Enrollment is complete in this Phase 1/2 study evaluating the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring, a harmful component of numerous retinal diseases. This study is a multi-dose, dose escalation trial conducted in patients with advanced neovascular or wet age-related macular degeneration (AMD) where retinal scarring can result in continued vision loss. The primary endpoint for RXI-109-1501 is to evaluate the safety and tolerability of RXI-109. Additional endpoints will assess RXI-109’s potential for clinical activity using numerous assessments to monitor ocular health and visual acuity. The Company expects to complete subject participation in the study by the end of 2017 and to share top-line data in early 2018.

RXI-SCP-1502 – Treatment of Cutaneous Warts
Samcyprone, a proprietary topical formulation of the small molecule diphenylcyclopropenone (DPCP), is being evaluated in a Phase 2a clinical trial. RXI-SCP-1502 is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart. The Company expects to share early read-outs before the end of this year.

RXI-231 – Consumer Care Products
The Company has initiated its consumer testing program with RXI-231, a cosmetic ingredient based on sd-rxRNA that targets tyrosinase (TYR). The cosmetic product is a gel formulation designed to aid in the reduction of pigmentation and thereby improving skin appearance. The consumer testing program will evaluate the use and consumer acceptability of RXI-231.

There are three studies under this program. The first two studies in volunteers are performed to determine irritation and sensitization potential of the gel product containing RXI-231 when applied to the skin. A third study investigates the potential of the product to improve the appearance of skin pigmentation induced by UV exposure. The Company projects to report results before the end of this year.

On August 10, 2017 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2017 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 10, 2017, View Source [SID1234520140]).

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"We have made great progress this year across our entire pipeline, both clinical and preclinical programs, which position us to achieve several important milestones throughout the balance of 2017, including an interim data analysis from our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia (AML)," said Peter Nielsen, President and CEO of Bio-Path Holdings. "Additionally, we were pleased to welcome Mark Colonnese to our Board of Directors. His extensive leadership, business development, and strategic planning experience, coupled with his financial expertise will be a significant asset to Bio-Path as we continue to grow the business and advance our DNAbilize platform."

Recent Corporate Highlights

· Received Notice of Allowance for Key U.S. Composition of Matter Patent. In July, the United States Patent and Trademark Office issued a notice of allowance for claims related to the Company’s proprietary liposomal delivery and antisense technology, DNAbilize. The new patent, titled "P-Ethoxy Nucleic Acids for Liposomal Formulation," (based on Application No. 15/294,223) provides broad protection for application of the DNAbilize technology in the treatment of a variety of cancers, as well as autoimmune and infectious diseases.

· Appointed Mark Colonnese to Board of Directors. In July, Bio-Path appointed Mark Colonnese, Chief Financial Officer of Aviragen Therapeutics (NASDAQ: AVIR), to its Board of Directors. Mr. Colonnese brings over 30 years of broad executive management skills and financial experience at Fortune 500 as well as small entrepreneurial companies. In these roles, he was responsible for raising $870 million in equity and debt capital, as well as $100 million from partnerships, and directing two companies through their initial public offerings.

Financial Results for the Second Quarter Ended June 30, 2017

The Company reported a net loss attributable to common stockholders of $3.0 million, or $0.03 per share, for the three months ended June 30, 2017, compared to a net loss attributable to common stockholders of $1.9 million, or $0.02 per share, for the three months ended June 30, 2016. The increase was primarily due to the deemed dividend related to the warrant conversion of $1.0 million during the period. The Company reported a net loss attributable to common stockholders of $3.4 million, or $0.04 per share, for the six months ended June 30, 2017, compared to a net loss attributable to common stockholders of $3.8 million, or $0.04 per share, for the six months ended June 30, 2016. The decrease was primarily due to total other income related to the change in fair value of the Company’s warrant liability and the loss on extinguishment of the liability totaling $1.9 million and was partially offset by the deemed dividend related to the warrant conversion of $1.0 million during the period.

Research and development expenses for the three months ended June 30, 2017 increased to $1.5 million, compared to $1.2 million for the three months ended June 30, 2016. For the six months ended June 30, 2017, research and development expenses increased to $2.5 million, compared to $2.2 million for the six months ended June 30, 2016.

General and administrative expenses for both the three months ended June 30, 2017 and June 30, 2016, were $0.8 million. For the six months ended June 30, 2017, general and administrative expenses increased to $1.8 million, compared to $1.6 million for the six months ended June 30, 2016.

As of June 30, 2017, the Company had cash of $6.2 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the six months ended June 30, 2017 was $4.2 million compared to $4.6 million for the comparable period in 2016. Net cash used in investing activities for the six months ended June 30, 2017 was $0.5 million. Net cash provided by financing activities for the six months ended June 30, 2017 was $1.5 million.

On August 10, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that the independent Data Safety Monitoring Board (DSMB) of the UNITY-NHL Phase 2b registration directed trial has successfully completed the first pre-specified interim analysis to evaluate the Overall Response Rate (ORR) in the cohort enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) that are not eligible for high-dose chemotherapy or transplant (Press release, TG Therapeutics, AUG 10, 2017, View Source [SID1234520139]). Upon review of the available ORR data, based on pre-specified efficacy thresholds of ORR, the DSMB recommended the Company cease enrollment into the single agent TGR-1202 arm, while continuing enrollment into the TG-1101 + TGR-1202 arm which has demonstrated an acceptable level of efficacy to warrant continued evaluation. Per the UNITY-NHL protocol, the single agent TGR-1202 arm will be replaced by an arm evaluating the triple combination arm of TG-1101, TGR-1202, and bendamustine.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "The DLBCL cohort in our UNITY-NHL trial was designed to evaluate the contribution of TGR-1202 in our combination ‘U2′ regimen. We are extremely pleased that the DSMB has recommended continued enrollment in the U2 arm, while allowing us to proceed with replacing the single agent TGR-1202 arm with the triple combination of TG-1101, TGR-1202, and bendamustine (also referred to as U2 + Benda) as planned. As recently presented, the triplet combination of U2 + Benda was highly active, with a 50% ORR in patients with refractory DLBCL and a 100% ORR in relapsed DLBCL patients. We have long believed that patients with aggressive DLBCL in particular are best treated with combination therapy rather than single agents and are pleased to see our UNITY-NHL study advancing to the next level."

ABOUT UNITY-NHL PHASE 2b TRIAL

UNITY-NHL is a global Phase 2b clinical trial evaluating TG-1101 and TGR-1202, ("U2"), in patients with various types of B-cell lymphoma. The trial consists of three independent cohorts enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), and Marginal Zone Lymphoma (MZL). The study is evaluating the U2 combination and the combination of U2 + bendamustine in patients with DLBCL; TGR-1202 monotherapy and in the U2 combination in patients with FL and SLL; and TGR-1202 monotherapy in patients with MZL.