On August 9, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported second quarter 2019 financial results (Press release, Epizyme, AUG 9, 2019, View Source [SID1234538518]).

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"Over the course of the first half of 2019, we made tremendous progress across all aspects of Epizyme’s business, and the second half of the year holds even greater opportunities as we transition to a commercial-stage company and work to achieve our Vision 2020," said Robert Bazemore, president and chief executive officer of Epizyme. "Our vision is to bring tazemetostat to both epithelioid sarcoma and follicular lymphoma patients, while also expanding its development in the future to additional tumor types and combinations, to advance research efforts to bring EZM8266 and other early programs into the clinic, and to further enhance our leadership in the field of epigenetic drug discovery and development. The milestones we have achieved so far this year, along with the anticipated clinical and regulatory catalysts over the next several months, position this to be our most significant year yet. We look forward to continuing our progress in an effort to impact the lives of as many people as we can."

Leadership Team Expansion

Epizyme recently appointed Paolo Tombesi as chief financial officer to further support the company’s transition to a commercial-stage organization. Mr. Tombesi brings over 30 years of extensive financial and accounting expertise to Epizyme, most recently serving as the chief financial officer at Insmed, Inc.

Tazemetostat for Epithelioid Sarcoma (ES)

NDA Submission Accepted for Priority Review: The U.S. Food and Drug Administration (FDA) has accepted for filing Epizyme’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent. The company has proposed an indication for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative surgery. The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 23, 2020. The submission is based primarily upon data from the 62 patient ES cohort in the company’s ongoing Phase 2 trial of tazemetostat, which were recently presented at ASCO (Free ASCO Whitepaper), and the safety and tolerability data generated across the tazemetostat development program.

Confirmatory Program Anticipated to Begin in 2H 2019: Epizyme has aligned on the design of its confirmatory trial to support full approval of tazemetostat for ES. The company plans to conduct a 1:1 randomized, controlled clinical trial in the front-line treatment setting comparing tazemetostat in combination with doxorubicin, a commonly used systemic treatment in this setting, versus placebo plus doxorubicin in approximately 150 patients. The primary efficacy endpoint will be progression-free survival, and secondary efficacy endpoints will include overall survival, disease control rate, overall response rate and duration of response. The safety run-in portion of the study is expected to begin in the second half of 2019.

Tazemetostat for Follicular Lymphoma (FL)

Planned NDA Submission for All-Comer FL on Track for Fourth Quarter: Epizyme is preparing to submit an NDA for accelerated approval of tazemetostat for the treatment of adult patients with relapsed or refractory FL, regardless of their EZH2 mutational status, who have received at least two prior systemic therapies. The company expects to submit the NDA for this indication in the fourth quarter of 2019.

Positive Updated Data from Ongoing Phase 2 Trial: At ICML, Epizyme presented data from the Phase 2 study of tazemetostat, as of a June 7, 2019 data cut off, showing that patients with an EZH2 mutation (n=43) had a 77% overall response rate (ORR) and a median duration of response (DOR) of 8.3 months. Patients with wild-type EZH2 (n=53) had a mature 34% ORR and 13-month DOR. Notably, favorable safety and tolerability were observed, with treatment-related adverse events resulting in only 5% of patients discontinuing treatment due to an adverse event. Enrollment is completed and the study is ongoing.

Confirmatory Program Anticipated to Begin in 2H 2019: To support full approval, Epizyme is planning to conduct a confirmatory program with an adaptive study evaluating the combination of tazemetostat with the chemo-free treatment regimen "R2" (Revlimid plus Rituxan) in the second line or later treatment setting for FL patients, both with and without EZH2 activating mutations. The final design is subject to alignment with FDA, and the company anticipates initiating the safety run-in portion in the second half of 2019.

FL Expansion Plans Established: Multiple additional clinical studies are anticipated to begin in the second half of 2019, and are designed to evaluate tazemetostat in earlier lines of FL treatment and in new combination regimens, including:

a combination study of tazemetostat with rituximab in patients with relapsed and/or refractory FL, and

a combination study of tazemetostat with R-CHOP in front-line patients in collaboration with the Lymphoma Study Association.

Tazemetostat for Additional Solid Tumors

Epizyme is planning several proof-of-concept clinical trials to begin in the second half of 2019 intended to explore the potential of new tazemetostat combinations in multiple solid tumor cancers, including:

a combination study of tazemetostat with the standards of care in patients with castration-resistant prostate cancer, and

a combination study of tazemetostat with a PARP inhibitor in patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer.

EZM8266 for Sickle Cell Disease

Epizyme anticipates beginning clinical development of EZM8266, a novel, first-in-class G9a inhibitor, with a Phase 1 clinical trial in the second half of 2019.

Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $331.0 million as of June 30, 2019, as compared to $215.6 million as of June 30, 2018.

Revenue: Collaboration revenue for the second quarter of 2019 was $5.9 million, compared to $12.0 million for the second quarter of 2018. The collaboration revenue recognized in the second quarter of 2019 relates to revenue earned as part of the company’s collaboration with Boehringer Ingelheim. In the second quarter of 2018, Epizyme recognized a $12.0 million milestone under its agreement with GlaxoSmithKline.

R&D Expenses: Research and development (R&D) expenses were $40.9 million for the second quarter of 2019, compared to $31.3 million for the second quarter of 2018. The increase is primarily due to a $10.0 million development milestone paid to Eisai in connection with the submission of the NDA in the second quarter of 2019

G&A Expenses: General and administrative (G&A) expenses were $15.7 million for the second quarter of 2019, compared to $10.9 million for the second quarter of 2018. The increase is due primarily to increased pre-commercialization activities and staffing, as well as increased personnel related expenses.

Net Loss Attributed to Common Stockholders: Net loss attributable to common stockholders was $48.5 million, or $0.53 per share, for the second quarter of 2019, compared to $29.1 million, or $0.42 per share, for the second quarter of 2018.

Financial Guidance

Based on its current operating plan, Epizyme continues to expect its cash runway to extend into the first quarter of 2021.

The company will not hold a conference call in conjunction with these results.

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.

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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 CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing in oncology and rare diseases, reported financial results for the second quarter ended June 30, 2019, and provided an overview of recent accomplishments (Press release, CytRx, AUG 9, 2019, View Source [SID1234538569]).

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"The first half of 2019 has been marked by significant achievements from our licensees, who continue to make progress in bringing CytRx’s technology closer to patients who are in need of novel and innovative therapies," said Eric Curtis, CytRx’s President and Chief Operating Officer. "As these partners continue to work diligently, CytRx stands to receive milestone payments and royalties, which may strengthen our balance sheet."

Second Quarter 2019 and Recent Highlights

CytRx Corporation

Orphazyme Prepares Regulatory Submission in United States and Europe for Niemann-Pick Disease Type C. In July 2019, CytRx highlighted that arimoclomol licensee Orphazyme announced that following a positive meeting with the U.S. Food and Drug Administration (FDA), the Company remains on track to submit a New Drug Application (NDA) for arimoclomol in NPC in the first half of 2020. Orphazyme also updated the anticipated timing for submission of its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for arimoclomol in Niemann-Pick disease Type C (NPC). Based on advice received from the EMA’s Scientific Advice Working Group, Orphazyme expects to submit the arimoclomol MAA in the first half of 2020. CytRx is eligible to receive up to $120 million in future milestones, plus royalties, from its arimoclomol licensing agreement with Orphazyme. Specifically, CytRx is eligible to receive $6 million in the U.S. and $4 million in Europe upon approval of arimoclomol in Orphazyme’s first non-ALS indication, plus royalties.
Licensee Orphazyme Completed Enrollment in Phase 3 Trial of Arimoclomol in Amyotrophic Lateral Sclerosis. In July 2019, CytRx highlighted that arimoclomol licensee Orphazyme A/S (ORPH.CO) has completed enrollment in its Phase 3 trial evaluating arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS) ahead of schedule. Orphazyme anticipates announcing top-line results from the Phase 3 trial in the first half of 2021.
New Patent Issued for Aldoxorubicin Formulation. In June 2019, CytRx highlighted that it has been issued a patent from the U.S. Patent and Trademark Office (USPTO) covering the formulation, storage, delivery and administration of aldoxorubicin at room temperature. The new patent, which issued on June 25, 2019 as U.S. Patent No. 10,328,093 and is titled "Anthracycline Formulations," covers a reconstituted formula of aldoxorubicin that stabilizes the compound, solubilizes it in ethanol and water, and eliminates the need for cold handling, allowing it to be administered to patients in all potential disease indications at room temperature.
CytRx Commences Trading on OTCQB Venture Market. In May 2019, CytRx announced that it commenced trading on the OTCQB Venture Market. The Company continues to trade under ticker symbol "CYTR". Investors can find current financial disclosure and real-time Level 2 quotes for the Company on www.otcmarkets.com/stock/CYTR/quote.
Patent Issued for the Use of Aldoxorubicin in the Treatment of Brain Cancer. In May 2019, CytRx announced that it had been issued a patent the USPTO covering the use of aldoxorubicin intravenously, intra-arterially or intramuscularly for the treatment of brain cancer. The new patent issued on May 7, 2019 as U.S. Patent No. 10,278,981, is titled "Cytotoxic Agents for The Treatment of Cancer." This patent was exclusively licensed by CytRx to NantCell in July 2017.
Orphazyme Completed Enrollment in its Phase 2/3 Clinical Trial in Systemic Inclusion Body Myositis. In April 2019, CytRx highlighted that arimoclomol licensee Orphazyme had completed enrollment in its Phase 2/3 clinical trial in Systemic Inclusion Body Myositis (sIBM). The Phase 2/3 trial is a 150-patient, 20-month, randomized, double-blind, placebo-controlled trial in 11 centers in the United States and one in the United Kingdom. Orphazyme expects to conduct an interim analysis in the first half of 2020 and to complete the study by the end of 2020, with results anticipated in the first half of 2021.
Second Quarter 2019 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $19.4 million as of June 30, 2019.

Net loss for the quarter ended June 30, 2019 was $1.3 million, or $(0.04) per share, compared with a net loss of $ 3.0 million, or $(0.10) per share, for the quarter ended June 30, 2018, a reduction of $1.7 million.

General and administrative (G&A) expenses were $1.5 million for the second quarter of 2019, compared with $ 1.7 million for the second quarter of 2018, including non-cash stock-compensation expense of $0.2 million for the second quarter of 2019 as compared to $ 0.4 million for the second quarter of 2018. G&A expenses decreased by approximately $0.2 million, or 9.4%, primarily due to a decrease in legal fees and a reduction in head count.

Based on our currently projected expenditures for the next 13 months, our monthly cash burn rate is estimated at approximately $400,000 per month.

On August 9, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2019 (Press release, Galectin Therapeutics, AUG 9, 2019, View Source [SID1234538519]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "Over the past several months we have made significant progress advancing our proprietary compound, belapectin (GR-MD-02) for a Phase 3 trial. After having raised approximately $44.9 million in our Rights Offering and selecting a leading global CRO with deep experience in our therapeutic area and operations in over 60 countries as our clinical research organization (CRO), we recently submitted our Phase 3 clinical trial protocols to the FDA for comment along with a draft Phase 4 synopsis and statistical analysis plan. In addition, we announced that Dr. Naga Chalasani and Dr. Stephen Harrison, key NASH opinion leaders, who dedicated considerable effort in the design of the study, have been designated as co-primary investigators in the Phase 3 NASH-RX clinical trial. Consequently, we believe all of the elements to commence this important study are solidly in place. Belapectin is the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices, and it is with great optimism that we anticipate a fourth quarter launch of this very important trial."

The NASH-RX trial is designed as an international, multicenter, randomized, placebo-controlled, double-blind, parallel-group, Phase 3 study with approximately 500 patients at up to 128 sites in 11 countries in North America, Europe, Asia, and Australia. The study is designed to evaluate the safety and efficacy of two doses of belapectin for the treatment of compensated non-alcoholic steatohepatitis (NASH) cirrhosis with clinical evidence of clinically significant portal hypertension without esophageal varices. Enrollment is expected to commence in the fourth quarter of 2019 with an estimated 12-14 months to achieve full enrollment. The treatment period for Phase 3 is two years, and topline data readout is expected around the end of 2022.

"With the continued support of the medical, patient, and investment communities we are excited to be advancing this new drug toward treating the millions of people globally with NASH cirrhosis."

Richard E. Uihlein, Chairman of the Board, added, "The success of the Rights Offering, the support of Drs. Chalasani and Harrison, execution of a start-up agreement with our CRO to accelerate time to patient enrollment, and the commitment and dedication of our employees provide Galectin with a world-class team that can ensure the upcoming clinical trials are rigorously administered. We are all looking forward to the launch of this trial in the fourth quarter and the data it will provide about the important role belapectin may play in helping those suffering from NASH cirrhosis."

Summary of Key Development Programs and Updates

Submitted our Phase 3 clinical trial protocol for using belapectin (GR-MD-02) for the treatment of compensated NASH cirrhosis in patients without esophageal varices for assessment by the FDA. Also, submitted to the FDA our complete clinical development plan, a draft Phase 4 synopsis, and statistical analysis plan among other documents in response to FDA’s questions from our February 2019 meeting.

Selected a leading global CRO with deep experience in NASH cirrhosis as our partner in the planned Phase 3 NASH-RX clinical trial and executed a start-up agreement.

Welcomed Drs. Harrison and Chalasani as Co-Principal Investigators, both of whom have been actively involved in the design of these upcoming trials and believe that this study could further the understanding of NASH and the role Galectin-3 inhibition may play in the treatment of this growing epidemic.

Raised $44.9 million in the Rights Offering and $2.5 million from a common stock warrant exercise by our chairman, Richard E. Uihlein. The Rights Offering, priced at $4.28 per share, resulted in the issuance of approximately 10.5 million shares of the Company’s common stock and stock purchase warrants for approximately 2.6 million shares at $7.00 per share which expire seven years after issuance. As a result, the Company now has approximately 56.6 million shares of common stock issued and outstanding.

Scientific Presentations and Conferences

Eliezer Zomer, Vice President, will present at the 3rd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 19, 2019, in Cambridge, Massachusetts. Dr. Zomer’s presentation titled "Therapeutic Integrin Inhibition," will discuss the next generation of Galectin-3 inhibitors, as well as the discovery of functional allosteric inhibitors as part of efforts of Galectin Sciences LLC, our majority owned subsidiary.

Financial Results

For the three months ended June 30, 2019, the Company reported a net loss applicable to common stockholders of $3.1 million, or $0.06 per share, compared to a net loss applicable to common stockholders of $4.1 million, or $0.11 per share, for the three months ended June 30, 2018. The decrease was primarily due to lower preclinical, clinical and non-cash stock-based compensation expenses in the current period compared to the prior year period.

Research and development expense for the three months ended June 30, 2019, was $1.5 million compared with $1.5 million for the three months ended June 30, 2018. There was an increase of about $0.6 million in clinical development expenses which was offset by a similar amount of decrease in non-cash stock-based compensation expense. General and administrative expense for the three months ended June 30, 2019, were $1.5 million, compared to $2.3 million for the three months ended June 30, 2018, primarily due to a decrease in non-cash stock-based compensation expenses.

As of June 30, 2019, the Company had $52.0 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date, and potential additional capital under its At the Market common stock issuance agreement. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2020. The Company expects that it will require more cash to fund operations after December 31, 2020 and believes it will be able to obtain additional financing as needed. The currently planned operations include estimated costs related to a planned Phase 3 clinical trial through December 31, 2020. While the costs of the trial and general overhead during the Phase 3 trial are expected to be approximately $100 million, the costs and timing of such trial is not yet completely finalized.

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]).

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"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