On August 9, 2019 Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s health and respiratory diseases, reported that the Company will release its second quarter 2019 financial results and provide a corporate update on Tuesday, August 13, 2019, after the close of the U.S. financial markets (Press release, Innovus Pharmaceuticals, AUG 9, 2019, http://client.irwebkit.com/innovuspharma/news/2442995 [SID1234538550]). The Company will host a conference call at 4:15 p.m. ET/1:15 p.m. PT on the same day to discuss the financial results and recent business developments.

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!

To participate in the call, please dial 1-877-270-2148 for domestic callers or 1-412-902-6510 for international callers and request to join the Innovus Pharmaceuticals conference call. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically, 855-669-9658 for Canada or 1-412-317-0088 internationally and reference Replay Access Code: 10134333. The replay will be available shortly after the end of the conference call.

On August 9, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 9, 2019, View Source [SID1234538547]).

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!

"Our team has continued to make significant progress on key initiatives during the second quarter, including the submission of the CMC modules to our rolling New Drug Application (NDA) for UGN-101. We have locked the database on our Phase 3 OLYMPUS study and are on track to complete the submission in Q4 as we prepare for a potential approval and launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are confident that our account-based commercial strategy will allow for seamless adoption and integration into urology practices following anticipated approval. We look forward to sharing further details about UGN-101 commercial preparations, ongoing clinical programs, and new developments at our Investor Day on September 24, 2019."

Recent Highlights and Upcoming Milestones

UGN-101 Clinical Development:

UroGen recently submitted the CMC modules to the rolling NDA for investigational agent UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Completion and acceptance of the Company’s rolling NDA submission remains on track for 2H 2019. If approved, the Company expects to launch UGN-101 in the United States in 1H 2020. It would be the first medicine approved for this unique, orphan indication.

At the 114th American Urological Association (AUA) Annual Meeting in Chicago, a presentation in the plenary session highlighted findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which demonstrated the unmet need and potential for UGN-101 to transform the treatment paradigm for patients with LG UTUC.

The Company expects to announce updated Phase 3 data from the OLYMPUS trial at its upcoming Investor Day on September 24, 2019.

Pipeline Advancement:

UGN-102:

The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of investigational agent UGN-102 (mitomycin gel) for intravesical instillation as a first line-chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC), a form of disease associated with a high risk of recurrence. UGN-102 has the potential to address an unmet need for the approximately 80,000 patients with intermediate risk LG NMIBC.

The OPTIMA II trial is enrolling ahead of schedule, and the company plans to present early complete response data on a portion of patients at its upcoming Investor Day on September 24, 2019.

If approved, UGN-102 would represent a novel advance in the treatment of recurrent non-muscle invasive bladder cancer, as there are currently no drugs approved by the FDA as first-line treatment for LG NMIBC.

UGN-201:

The Company is developing investigational agent UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease. UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC.

Commercial Preparations:

UroGen has made considerable progress to accelerate educational initiatives to drive awareness of the significant unmet need for patients with LG UTUC where current SOC is kidney removal. Little education and support have previously been available for patients and stakeholders and UroGen is in a unique position to lead in this space. These pre-commercial activities and infrastructure build out will help to reinforce rapid adoption and seamless integration of UGN-101 into urology practices following anticipated regulatory approval.

In conjunction with the Company’s educational efforts, UroGen is also engaging in a proactive market access strategy to define the cost burden to the system for LG UTUC via an HEOR study.

Corporate:

Robert G. Uzzo, M.D., FACS, Chair of the Department of Surgical Oncology at Fox Chase Cancer Center in Philadelphia, PA, has joined UroGen as a special advisor working closely with UroGen’s Medical Affairs team. Dr. Uzzo is well-known as a key opinion leader in the field of urological oncology and has made important clinical and scientific contributions to the field.

In the second quarter, UroGen entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

The Company will host a live webcast in conjunction with its Investor Day taking place on Tuesday, September 24th at 10:00AM Eastern Time in New York, NY.

Second Quarter 2019 Financial Results; 2019 Guidance

As of June 30, 2019, cash, cash equivalents and marketable securities totaled $233.3 million.

Research and development expenses for the three months ended June 30, 2019 were $10.0 million, including non-cash share-based compensation expense of $2.0 million. Research and development expenses for the six months ended June 30, 2019 were $19.7 million, including non-cash share-based compensation expense of $4.3 million.

General and administrative expenses for the three months ended June 30, 2019 were $13.8 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the six months ended June 30, 2019 were $26.5 million, including non-cash share-based compensation expense of $10.3 million.

The Company reported a net loss of $22.5 million, or basic and diluted net loss per ordinary share of $1.08, for the three months ended June 30, 2019. The Company reported a net loss of $43.9 million, or basic and diluted net loss per ordinary share of $2.19, for the six months ended June 30, 2019.

The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28, 2019 remains the same based on current business goals and anticipated activities.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast on Monday, August 12, 2019 at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48773603. An archive of the webcast will be available for two weeks on the Company’s website.

On August 9, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and provided a business update for the second quarter ended June 30, 2019 (Press release, Cempra, AUG 9, 2019, View Source [SID1234538546]).

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!

"Melinta’s second quarter 2019 results were driven by accelerating product sales, disciplined financial stewardship, and improved operational efficiencies. We continue to make strides towards expanding the market for our product portfolio with the potential approval of Baxdela (delafloxacin) for community-acquired bacterial pneumonia (CABP) and have enrolled more than half of the target study population in a clinical study evaluating a shorter infusion time formulation of Orbactiv (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI)," said John H. Johnson, chief executive officer of Melinta. "We also applaud the recent and final ruling from the Centers for Medicare & Medicaid Services (CMS) to increase the new technology add-on payment, or NTAP, for Vabomere (meropenem and vaborbactam) from 50 to 75 percent for the fiscal year 2020, which will be effective October 1, 2019," Johnson added.

"We are encouraged with the progress we have made toward our financial stewardship goals and product sales revenue growth. However, we continue to face significant risk relative to near-term compliance with the Company’s financial commitments and covenants under its credit and convertible notes facilities. We are working diligently to negotiate with our creditors to navigate a path forward to continue executing against our strategy to provide effective antibiotics for patients in need," said Peter Milligan, chief financial officer of Melinta.

Second Quarter 2019 Financial Results
Melinta reported revenue of $16.0 million and $12.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018. Revenue from product sales was $13.8 million in the second quarter of 2019, up 51 percent1 from the second quarter of 2018. Revenue from product sales was $25.6 million for the six-month period ended June 30, 2019, up 22 percent1 from $21.0 million reported in the six-month period ended June 30, 2018.

Cost of goods sold (COGS) was $8.6 million and $11.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018, respectively, including $4.1 million and $3.5 million of non-cash amortization of intangible assets. For the six-month periods ending June 30, 2019 and 2018, COGS was $16.0 million and $18.7 million, respectively, including $8.2 million of non-cash amortization of intangible assets in each period.
Research and development (R&D) expenses were $3.5 million and $15.8 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $8.9 million and $31.9 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, R&D expenses decreased year-over-year primarily as a result of the completion of the Company’s Phase 3 study for Baxdela in CABP as well as winding down its early research and discovery programs, which was completed in March 2019.

1 In connection with its second quarter 2018 earnings release, Melinta disclosed that in the second quarter of 2018, net product sales were negatively impacted by approximately $2.7 million related to the integration of distribution channels in connection with the acquisition of the infectious disease business of The Medicines Company. Absent this integration activity in the second quarter of 2018, net product sales for the three- and six-month periods ended June 30, 2019 would have increased 17 percent and 8 percent, respectively, year-over-year.

Selling, general and administrative (SG&A) expenses were $30.9 million and $34.9 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $56.9 million and $69.6 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, SG&A expenses decreased year-over-year primarily as a result of the cost-cutting measures the Company initiated in the fourth quarter of 2018.
Net loss was $36.2 million, or $3.07 per share, for the three-month period ended June 30, 2019, compared to a net loss of $55.8 million, or $6.92 per share, for the three-month period ended June 30, 2018. Net loss was $62.7 million, or $5.42 per share, for the six-month period ended June 30, 2019, compared to a net loss of $85.2 million, or $11.96 per share, for the six-month period ended June 30, 2018. Net loss per share year-over-year reflects changes in share count as a result of the one-for-five reverse stock split effective on February 22, 2019.
The Company ended the quarter with $90.3 million of cash and cash equivalents.
The Company is not providing any financial guidance for the full-year 2019.
Recent Portfolio Updates

CMS released the final rule for the 2020 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and has increased the NTAP for Vabomere, from 50 to 75 percent for the fiscal year 2020, which is effective October 1, 2019

The U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019

In July, the Company commenced enrollment in a Phase 1 study to evaluate the pharmacokinetics and safety of a new formulation of Orbactiv versus the approved formulation in subjects with ABSSSI; the new formulation aims to reduce infusion time from three hours to one hour

The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae

Our partners in Latin America sold the first commercial product of Baxdela outside of the United States in Uruguay

Upcoming Potential Catalysts

FDA approval for Baxdela for the treatment of CABP in adults by October 24, 2019

European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for ABSSSI

Country approvals for Baxdela in South America and Central America

On August 9, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy and infusion services, reported financial results for the quarter ended June 30, 2019 (Press release, Diplomat Speciality Pharmacy, AUG 9, 2019, View Source [SID1234538545]). All comparisons, unless otherwise noted, are to the quarter ended June 30, 2018.

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!

Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Second Quarter 2019 Highlights include:

Revenue of $1,288 million, compared to $1,416 million
Specialty segment revenue of $1,216 million, compared to $1,234 million
PBM segment revenue of $90 million, compared to $189 million
Specialty segment total prescriptions dispensed of 235,000, compared to 236,000
PBM segment total volume, adjusted to 30-day equivalent, of 942,000, compared to 2,123,000
Gross margin of 5.6% versus 6.9%
Specialty segment gross margin of 5.2% versus 5.9%
PBM segment gross margin of 10.7% versus 13.7%
EPS of $(2.13) per basic/diluted common share versus $(0.05) per basic/diluted common share
Adjusted EBITDA of $19.3 million, compared to $42.7 million
Adjusted EBITDA margin of 1.5% versus 3.0%
Net cash provided by operating activities was $43.1 million, compared to $18.1 million
Net debt1 decreased to $584.8 million, from $622.5 million at March 31, 2019.
Brian Griffin, Chairman and CEO of Diplomat, commented "We continue to believe in our business model and long-term prospects and we remain encouraged by our pipeline for 2020, despite our reduced guidance for 2019. We are pleased that infusion therapies continue to demonstrate strength and we are taking actions to improve our core specialty pharmacy business, rebuild our PBM and enhance our financial flexibility. At the same time, our Board has concluded that a broad review of strategic alternatives is in the best interests of the Company and our shareholders. While this is taking place, we intend to maintain our focus on executing our strategic plan, improving our businesses and supporting our shareholders, patients and their providers, payers, as well as our manufacturer partners and our employees."

Second Quarter Financial Summary:

Revenue for the second quarter of 2019 was $1,288 million, compared to $1,416 million in the second quarter of 2018, a decrease of $128 million or 9%. Our Specialty segment revenue amounted to $1,216 million, compared to $1,234 million in the prior year quarter, while revenue from our PBM segment amounted to $90 million, compared to $189 million in the prior year quarter. The decrease in our Specialty segment was primarily driven by payor reimbursement compression and the conversion of brand name drugs to their generic equivalent. The decrease was partially offset by the benefit of manufacturer price increases and growth in infusion therapies. The decrease in our PBM segment was due to previously disclosed contract losses.

Gross profit in the second quarter of 2019 was $72.7 million and generated a 5.6% gross margin, compared to $98.4 million gross profit and a 6.9% gross margin in the second quarter of 2018. Gross profit from our Specialty segment was $63.0 million and generated a 5.2% gross margin, compared to $72.5 million and a 5.9% gross margin in the prior period. The gross margin decrease in our Specialty segment was primarily driven by payor reimbursement compression. Gross profit from our PBM segment was $9.7 million and generated a 10.7% gross margin, compared to $25.9 million and a 13.7% gross margin in the prior period. The gross margin decrease in our PBM segment was primarily driven by a $2.5 million non-recurring client rebate payment.

Selling, general and administrative expenses for the second quarter of 2019 were $80.8 million, a decrease of $9.8 million, compared to $90.6 million in the second quarter of 2018. This decrease was primarily driven by a $4.2 million decrease in amortization expense, largely due to the impairment of our PBM segment in the fourth quarter of 2018, a $3.0 million decrease in merger and acquisition related expenses, and a $2.7 million decrease in share-based compensation expense primarily due to the recognition of our CEO share based RSU grant in the prior year period. We also reduced our consulting and recruiting expenses. These reductions were partially offset by an increase in severance, insurance, and facility expenses.

Net loss for the second quarter of 2019 was $(159.5) million compared to $(4.0) million in the second quarter of 2018. This decrease was primarily driven by an $85 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our Specialty segment, as well as a $56 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment both due to a reduced forecast. The forecast reduction in Diplomat Specialty Pharmacy ("DSP"), a reporting unit within our Specialty segment, is due to less favorable drug mix, continued reimbursement pressure, slower than anticipated volume growth from our payor team investment, and a delay in implementing our new operating system which is also delaying the anticipated efficiencies. The PBM segment forecast reduction is due to lower earned rebates due to drug mix, slightly lower rebate retention, and a more conservative outlook for growth. Adjusted EBITDA for the second quarter of 2019 was $19.3 million compared to $42.7 million in the second quarter of 2018, a decrease of $23.4 million.

Loss per share for the second quarter of 2019 was $(2.13) per basic/diluted common share, compared to $(0.05) per basic/diluted common share for the second quarter of 2018.

2019 Financial Outlook

For the full-year 2019, we are updating our previous financial guidance:

Revenue between $4.7 and $5.0 billion
Specialty segment revenue between $4.4 and $4.6 billion
PBM segment revenue between $0.325 and $0.375 billion
Net loss between $(201) and $(191) million, versus the previous range of $(49) and $(33) million
Adjusted EBITDA between $87 and $93 million, versus the previous range of $110 and $116 million
Diluted EPS between $(2.69) and $(2.55), versus the previous range of $(0.65) and $(0.44)
Our income tax expectation for the year is an expense range of $1.5 to $2.0 million, primarily related to state taxes. A federal tax benefit will not be recorded for our 2019 losses as we are required to record a valuation allowance against any such benefit due to being in a cumulative loss position. Our EPS expectations for 2019 assume approximately 74,750,000 weighted average common shares outstanding on a diluted basis, versus the prior expectation of approximately 75,300,000, which could differ materially.

We have recently agreed with our lenders to amend certain financial performance covenants applicable to our credit facility. Amended terms became effective August 6, 2019 and amend the Total Net Leverage Ratio and Interest Coverage Ratio for the periods from the third quarter of 2019 through the fourth quarter of 2020, which is expected to provide the Company financial flexibility. As of March 31, 2021, the covenants revert back to the levels indicated in the original credit facility. Additional details are available in our Current Report on Form 8-K filed with the Securities and Exchange Commission on August 9, 2019.

Earnings Conference Call Information

As previously announced, the Company will hold a conference call to discuss its second quarter performance this morning, August 9, 2019, at 8:30 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833.286.5805 (647.689.4450 for international callers) and referencing participant code 7394702 approximately 15 minutes prior to the call. A live webcast of the conference call and associated slide presentation will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is.

On August 9, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ended June 30, 2019 and recent company developments (Press release, TG Therapeutics, AUG 9, 2019, View Source [SID1234538544]).

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, "As we enter into the second half of the year, we are pleased with the progress made thus far and excited for the upcoming milestones. With a well-defined path to a regulatory submission for umbralisib in marginal zone lymphoma, we feel confident that we are at a pivotal point in our Company’s lifecycle." Mr. Weiss continued, "As we prepare for our first filing in MZL, we are also building a top-notch commercial organization which will fuel the long-term success of TG. And with pivotal data readouts also expected in CLL and MS over the next 6-12 months, we believe we are at the beginning of an extremely exciting transformational period for our Company."

Recent Developments and Highlights

Marginal Zone Lymphoma – Confirmed Registration Path: Announced confirmation of registration path to submit umbralisib for accelerated approval based on data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b trial.

Positive Interim Data from MZL Cohort of UNITY-NHL Trial: Presented positive interim data from the MZL cohort of the UNITY-NHL trial during oral presentations at the 55thAmerican Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the 2019 International Conference on Malignant Lymphoma (ICML).

Ublituximab Data in Multiple Sclerosis: Presented long-term follow-up data from the Phase 2 trial of ublituximab in patients with relapsing forms of multiple sclerosis (RMS) at the 5th Congress of the European Academy of Neurology (EAN).

Umbralisib Data in CLL and RT: Presented Phase 2 data of umbralisib in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3k delta inhibitor therapy, and also presented data from patients with relapsed/refractory CLL or Richter’s Transformation (RT) treated with the triple combination of ublituximab, umbralisib and pembrolizumab.

TG-1801 Preclinical Data: Presented the first preclinical data of TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) annual congress.
Remaining 2019 and Early 2020 Milestones

Initiate a rolling New Drug Application (NDA) submission for patients with previously treated MZL

Present final data from the MZL cohort of the UNITY-NHL registration directed trial evaluating umbralisib in MZL

Potential top-line progression free survival (PFS) results from the Phase 3 UNITY-CLL trial evaluating U2 in patients with CLL

Present updated data from our pipeline products and combination studies at upcoming major medical conferences
Financial Results for the Three and Six Months Ended June 30, 2019

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation and non-cash in-licensing expense) was $31.4 million and $62.3 million for the three and sixth months ended June 30, 2019 compared to $34.8 million and $66.0 million for the three and six months ended June 30, 2018. The decrease in other R&D expense is primarily attributable to a decrease in clinical trial expenses of $9.7 million and $10.4 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods, offset by an increase in manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization of $7.9 million and $4.7 million, respectively during the three and six months ended June 30, 2019, as compared to prior periods. 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 other R&D expenses to decrease through the remainder of 2019.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.3 million and $4.3 million for the three and six months ended June 30, 2019 as compared to $2.3 million and $4.4 million for the three and six months ended June 30, 2018. Other G&A expenses remained relatively flat compared to the prior period, and we expect Other G&A expenses to increase modestly through the remainder of 2019.

Net Loss: Net loss was $36.2 million and $71.4 million for the three and six months ended June 30, 2019, respectively, compared to a net loss of $44.1 million and $85.7 million for the three and six months ended June 30, 2018, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2019 was approximately $34.4 million and $67.6 million. We expect our quarterly net loss to decrease through the remainder of 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $85.0 million as of June 30, 2019. Pro forma cash, cash equivalents and investment securities as of June 30, 2019 (excluding our third quarter 2019 operations) are approximately $96.6 million, after giving effect to $11.6 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the third quarter of 2019. The Company believes its cash, cash equivalents and investment securities on hand as of June 30, 2019, inclusive of the proceeds raised from the ATM facility subsequent to the second quarter, as well as future availability under the ATM facility, will be sufficient to fund the Company’s planned operations through the third quarter of 2020.
Conference Call Information

The Company will host a conference call today, August 9, 2019, at 8:30 am ET, to discuss the Company’s second quarter 2019 financial results and provide a business outlook for the remainder of 2019.

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 Second 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 View Source 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.