On August 10, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2020 (Press release, Eagle Pharmaceuticals, AUG 10, 2020, View Source [SID1234563273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Business and Recent Highlights:

·Centers for Medicare & Medicaid Services ("CMS") established unique Healthcare Common Procedure Coding System ("HCPCS") code, or J-code, for PEMFEXY (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA effective October 1, 2020;

·Granted a supplement approval by U.S. Food and Drug Administration ("FDA") for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022;

·The Company’s strategic collaboration partner, Tyme Technologies, Inc. ("Tyme"), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer;

·On August 7, 2020, the Company received a Complete Response Letter for its New Drug Application ("NDA") for RYANODEX for the treatment of exertional heat stroke ("EHS"); Eagle has decided that it will no longer pursue this indication;

·Received encouraging recent additional data for the Company’s fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer; next steps are to meet with FDA to finalize clinical trial plans; product could potentially represent cornerstone of Eagle’s oncology franchise treating HR positive breast cancer patients;

·Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed Abbreviated New Drug Application ("ANDA") products. Under this decision, defendants are enjoined from launching their ANDA products before 2031;

Page 2: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

·SymBio, the Company’s Japanese licensing partner, announced that it expects regulatory approval of its TREAKISYM Ready-to-Dilute ("RTD") formulation late this year. Eagle is entitled to receive a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute or TREAKISYM Rapid Infusion, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its Rapid Infusion product; and

·Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plan; the Company has experienced limited impacts on the timing of its pre-clinical programs due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.

Second Quarter 2020 Financial Highlights

·Total revenue for Q2 2020 was $41.9 million, compared to $56.7 million in Q2 2019, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of RYANODEX.

·Net loss for Q2 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income for Q2 2019 of $6.7 million, or $0.49 per basic and $0.48 per diluted share.

·Adjusted non-GAAP net income for Q2 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income for Q2 2019 of $11.8 million, or $0.86 per basic and $0.84 per diluted share.

·Cash and cash equivalents were $108.2 million, net accounts receivable was $46.8 million, and debt was $37.0 million as of June 30, 2020.

"We had an excellent start to the first half of the year, advancing our exciting pipeline of oncology and critical care products. Our ANDA and orphan drug exclusivity legal wins for BENDEKA, CMS’ decision to establish a separate J-Code and supplement approval for the 500mg dose for PEMFEXY, along with continued progress on our fulvestrant product candidate and the opportunity for vasopressin, supports the diversification and acceleration of Eagle’s earnings power," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Gross margin was 69% during the second quarter of 2020, as compared to 62% in the second quarter of 2019. The expansion in gross margin in the second quarter of 2020 was driven by an increase in RYANODEX product sales, lower BENDEKA product sales in the period to the Company’s marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $7.1 million for the second quarter of 2020, compared to $9.0 million in the second quarter of 2019. The change primarily resulted from a decrease in spending for vasopressin, partly offset by an increase in spending for the Company’s fulvestrant product candidate. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2020 was $6.0 million.

SG&A expense in the second quarter of 2020 increased to $18.0 million compared to $17.2 million in the second quarter of 2019. The change primarily resulted from an increase in stock compensation expense, partially offset by decreases in T&E, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2020 SG&A expense was $12.2 million.

Net loss for the second quarter of 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in the second quarter of 2019.

Adjusted non-GAAP net income for the second quarter of 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income of $11.8 million or $0.86 per basic and $0.84 per diluted share in the second quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

"We’re also pleased with our collaborations with Tyme, NorthShore University HealthSystem, and UPenn to advance important products. Furthermore, we have made progress on the study of RYANODEX for the treatment of brain damage secondary to Nerve Agent exposure, as we continue to pursue expanded indications. We have important work ahead in the second half of the year, regardless of EHS, and we will continue to identify opportunities that fulfill our strategic vision and bring innovative therapeutics to the patients who can benefit," concluded Tarriff.

Second Quarter 2020 Financial Results

Total revenue for Q2 2020 was $41.9 million, as compared to $56.7 million for Q2 2019.

Page 3: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

Q2 2020 BELRAPZO product sales were $4.1 million, compared to $15.4 million in Q2 2019. Second quarter 2019 BELRAPZO revenue reflected wholesaler stocking occasioned by the June 2019 transition to the branded name.

Q2 2020 RYANODEX product sales were $4.7 million, compared to $2.9 million in Q2 2019.

2020 Expense Guidance

·As a result of COVID-related delays, with respect to our pre-clinical programs, we are lowering our previously reported 2020 R&D Non-GAAP expense guidance to $40 million-$44 million, as compared to $31 million in 2019.

Page 4: Eagle Pharmaceuticals Reports Second Quarter 2020 Results

·SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of June 30, 2020, the Company had $108.2 million in cash and cash equivalents plus $46.8 million in net accounts receivable, $35.7 million of which was due from Teva. The Company had $37.0 million in outstanding debt. Therefore, at June 30, 2020, the Company had net cash plus receivables of $118.0 million. In the second quarter of 2020, the Company repaid the full $110.0 million amount borrowed under its revolving credit facility.

In the second quarter of 2020, the Company repurchased $4.0 million of Eagle’s common stock as part of the share repurchase program. From August 2016 through June 30, 2020, the Company repurchased $176.9 million of its common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2020 conference call as follows:

Date Monday, August 10, 2020

Time 8:30 A.M. ET

Toll free (U.S.) 877-876-9173

International 785-424-1667

Webcast (live and replay) www.eagleus.com, under the "Investor + News" section

Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

On August 10, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the second quarter of 2020 ended June 30, 2020 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, AUG 10, 2020, View Source [SID1234563272]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to beginning the phase 2 trials of our lead clinical programs, PRS-343 and PRS-060, later this year. In preparation for the phase 2 trial of PRS-343 with ramucirumab and paclitaxel, we have signed a clinical trial collaboration agreement for supply of ramucirumab with Lilly, which will give us the ability to explore the potential merits of this combination regimen while managing costs efficiently," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We also have made measurable progress in our collaboration with Seattle Genetics, achieving a key preclinical milestone for the first of up to three bispecific programs we are developing as part of that alliance."

PRS-060: Pieris and AstraZeneca are preparing to initiate the phase 2a study of PRS-060/AZD1402 in the fourth quarter of 2020. The study of PRS-060/AZD1402, which is being developed for the treatment of moderate-to-severe asthma, will be sponsored, funded, and delivered by AstraZeneca. Upon completion of that study, Pieris will have the options to co-develop and, subsequently, co-commercialize PRS-060/AZD1402 in the United States.
PRS-343: Pieris is working towards the initiation of a phase 2 single-arm study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with ramucirumab and paclitaxel in the second line of treatment of HER2-positive gastric cancer later this year. The U.S. Food and Drug Administration (FDA) has provided input on the design of the planned proof-of-concept study, and, pending the successful completion of an additional in-use and compatibility study in connection with the partial clinical hold placed on the phase 1 studies of the drug candidate, which the company is designing with input from FDA and plans to initiate later this month, the Company expects to initiate a phase 2 study in second-line gastric cancer in combination with the standard of care this year. Although Pieris cannot enroll new patients into the phase 1 studies of PRS-343 until resolution of this partial hold, currently-enrolled patients may continue to receive treatment. Additionally, Pieris will present phase 1 dose-escalation monotherapy and combination with atezolizumab data for PRS-343 in an oral presentation session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020.
Ramucirumab Drug Supply Agreement: Pieris has entered into a clinical trial collaboration agreement with Eli Lilly and Company to evaluate the safety and efficacy of combining Pieris’ PRS-343 with Lilly’s ramucirumab, a VEGFR2 antagonist FDA-approved for multiple types of solid tumors, and paclitaxel in second-line treatment of HER2-positive gastric cancer in a phase 2 study. Under the terms of the agreement, Lilly will supply Pieris with ramucirumab, as well as collaborate on data from the trial.
Seattle Genetics Collaboration: Pieris achieved a key preclinical milestone for one of the programs in the collaboration, a bispecific tumor-targeted costimulatory agonist, triggering a $5 million milestone payment. The program is one of up to three potential programs in the Seattle Genetics alliance, and the achieved milestone further validates Pieris’ approach and leadership in immuno-oncology bispecifics, complementing the encouraging clinical data seen with PRS-343. Pieris has handed the program over to Seattle Genetics, who is responsible for further advancement and funding of the asset.
Servier Collaboration: Pieris and Servier continue development of PRS-344 and PRS-352. Pieris anticipates filing an IND application for PRS-344, a 4-1BB/PD-L1 bispecific, next year. The Company holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Pieris is also focused on completing the non-GLP preclinical work for PRS-352, a preclinical-stage program addressing undisclosed targets, and expects to hand it over to Servier in the fourth quarter of this year.
Preclinical Respiratory Pipeline: Beyond PRS-060, Pieris continues to advance three discovery programs in its five-program respiratory collaboration with AstraZeneca. Pieris expects AstraZeneca will initiate the fourth discovery program in the collaboration later this year. The Company also continues to advance several proprietary discovery-stage respiratory programs. Pieris expects to share data and rationale for advancement of one of its proprietary programs in later this year.
Fiscal Year Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $77.2 million for the quarter ended June 30, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the quarter ended December 31, 2019. The decrease was due primarily to operating cash expenses and capital as well as one-time expenditures associated with the move to a new R&D facility in Hallbergmoos, Germany in the first quarter of 2020.

R&D Expense – R&D expenses were $11.3 million for the quarter ended June 30, 2020, compared to $13.4 million for the quarter ended June 30, 2019. The decrease in R&D expenses was due primarily to lower manufacturing spending on PRS-344, PRS-060, and other preclinical programs, lower costs on non-core programs, and lower travel-related expenditures due to COVID-19 restrictions, all partially offset by an increase in allocated IT and facility costs due to the move to the new facility and higher personnel costs.

G&A Expense – G&A expenses were $4.6 million for the quarter ended June 30, 2020, compared to $4.2 million for the quarter ended June 30, 2019. The increase in G&A expenses was due primarily to higher legal expense, audit expense, and allocated IT and facility costs due to the move to the new facility. These increases were partially offset by lower personnel costs, professional services, and travel-related expenditures due to COVID-19 restrictions.

Net Loss – Net loss was $5.0 million or $(0.09) per share for the quarter ended June 30, 2020, compared to a net loss of $11.8 million or $(0.24) per share for the quarter ended June 30, 2019.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Monday, August 10, 2020, to discuss the second quarter financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On August 10, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will participate in a virtual fireside chat at the Canaccord Genuity 40th Annual Growth Conference (Press release, Oncolytics Biotech, AUG 10, 2020, View Source [SID1234563271]). Presentation details are listed below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presenter: Kirk Look, Chief Financial Officer of Oncolytics Biotech Inc.
Date: Wednesday, August 12, 2020
Time: 8:00 am ET
Webcast Link: Available here

The Company will also be participating in one-on-one investor meetings. To schedule a meeting, please contact your Canaccord representative or email [email protected].

A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for one week.

On August 10, 2020 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, AUG 10, 2020, View Source [SID1234563270]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter, we delivered on two very important milestones for the company: announcing positive topline results in our BRIDGE phase III clinical trial of PRX-102 for the treatment of Fabry disease and subsequent BLA submission to the U.S. Food and Drug Administration (FDA). We were able to accomplish these goals even as we faced the challenging headwinds from the global COVID-19 pandemic, and I am very proud of our entire team for their commitment and dedication," said Dror Bashan, Protalix’s President and Chief Executive Officer. "As we look towards an exciting second half of the year, we are continuing to build Protalix for the long term. We augmented our research and development team with highly qualified and seasoned veterans to support and enhance our pipeline, and we announced a new partnership to explore the development of PRX-110." Mr. Bashan concluded, "We are gratified to have a balance sheet supporting our strategic plans and look forward to continuing to execute as we move towards the anticipated commercial launch of PRX-102 for the treatment of Fabry disease."

Recent Business Highlights

·Submitted a Biologics License Application (BLA) to the FDA for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease on May 27, 2020. The BLA was submitted under the FDA’s accelerated approval pathway in collaboration with the Company’s development and commercialization partner, Chiesi Farmaceutici S.p.A. On July 28, 2020, the FDA informed Chiesi that the BLA had been filed for review and that the FDA was working on the 74-day letter. In addition, the FDA informed Chiesi that no "Refuse To File" will be issued for the PRX-102 BLA.

Announced positive topline results from our BRIDGE Phase III clinical trial of PRX-102 for the treatment of Fabry disease. The study was an open-label, switch-over trial designed to evaluate the safety and efficacy of 1 mg/kg PRX-102 infused every two weeks, in Fabry patients. The trial met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX-102.

·Enhanced the executive management team with the appointment of Yael Hayon, Ph.D. as Vice President, Research and Development. Dr. Hayon brings over a decade of pharmaceutical research and development experience in both the scientific operations and administrative functions.

·Entered into a non-binding term sheet with SarcoMed USA, Inc. to explore the development and commercialization of PRX-110 (alidornase alfa) in the treatment of Pulmonary Sarcoidosis and related diseases. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in Pulmonary Sarcoidosis patients.

Second Quarter 2020 Financial Highlights

The Company recorded revenues from selling goods of $3.6 million during the three months ended June 30, 2020, an increase of $0.2 million, or 6%, compared to revenues of $3.4 million for the same period of 2019.

Revenues from license and R&D services for the three months ended June 30, 2020, were $7.3 million, a decrease of $1.5 million, or 17%, compared to revenues of $8.8 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 as well as lower costs related to the Company’s phase III BALANCE clinical trial of PRX-102 for the treatment of Fabry disease.

Cost of goods sold was $1.8 million for the three months ended June 30, 2020, a decrease of $0.9 million, or 32%, from cost of goods sold of $2.7 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.

Research and development expenses were $9.2 million for the three months ended June 30, 2020, a decrease of $4.1 million, or 31%, compared to $13.3 million of research and development expenses for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the Company’s phase III BALANCE clinical trial as well as a decrease in costs related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory.

Selling, general and administrative expenses were $2.2 million for the three months ended June 30, 2020, an increase of $0.1 million, or 6%, compared to $2.1 million for the same period of 2019.

Cash and cash equivalents at June 30, 2020 was $4.8 million, with $35.2 million in bank deposits.

Conference Call and Webcast Information

The Company will host a conference call on Monday, August 10, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate, and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13706783
Webcast: View Source

The conference call will be broadcast live and also available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On August 10, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ended June 30, 2020 and recent company developments (Press release, TG Therapeutics, AUG 10, 2020, View Source [SID1234563261]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased by the progress made thus far in 2020 and are looking forward to an impactful end of year and into 2021. Completing the NDA rolling submission this past June for umbralisib in previously treated Marginal Zone Lymphoma and Follicular Lymphoma was a major milestone for our Company." Mr. Weiss continued, "With one completed NDA submission, positive topline data from our UNITY-CLL Phase 3 trial, and a healthy balance sheet with over $275 million in cash, we are well positioned to execute on our remaining milestones for this year as well as transition from a development stage company to a fully-integrated commercial organization. For the remainder of this year, we look forward to reporting topline data from our Phase 3 ULTIMATE program in Multiple Sclerosis, full data presentations from the UNITY-NHL FL and MZL single agent umbralisib cohorts, data presentation from the UNITY-CLL Phase 3 trial, as well as updated data from our triple combination trials, which we believe set the stage for the future of U2 in CLL and non-Hodgkin’s Lymphoma."

Recent Developments and Highlights

Marginal Zone Lymphoma & Follicular Lymphoma:
° In 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:
° In 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).
° In 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:
° In 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:
° In May 2020, strengthened balance sheet with more than $240 million in gross proceeds through a public offering and the Company’s At-the-Market (ATM) facility.

Publication:
° In July 2020, published preclinical data describing the unique immunomodulatory effects of umbralisib, in Blood Advances, a Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Board of Directors & Management:
° In May 2020, appointed Sagar Lonial, MD, FACP, Professor and Chair of the Department of Hematology and Medical Oncology at 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.
° In 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 June 30, 2020

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $34.9 million and $68.9 million for the three and six months ended June 30, 2020, respectively, compared to $31.4 million and $62.3 million for 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 million and $13.8 million for the three and six months ended June 30 2020, respectively, as compared to $2.3 million and $4.3 million for 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 million and $104.0 million for the three and six months ended June 30, 2020, respectively, compared to a net loss of $36.2 million and $71.4 million for 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, 2020 was approximately $45.5 million and $85.6 million, respectively, compared to a net loss of $34.5 million and $67.7 million for the three and six months ended June 30, 2019, respectively.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $275.6 million as 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.