1stOncology™: Cancer Intelligence Service – Page 12625 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Magenta Therapeutics Reports Second Quarter 2019 Financial Results and Recent Business Highlights

On August 8, 2019 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported financial results for the second quarter ended June 30, 2019 and recent business highlights (Press release, Magenta Therapeutics, AUG 8, 2019, View Source [SID1234538423]).

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!

"In the first half of 2019, Magenta made meaningful progress in executing on our goals, including advancing our second program into the clinic and extending our cash runway through a follow-on financing," said Jason Gardner, D. Phil., Chief Executive Officer and President, Magenta Therapeutics. "We look forward to sharing results of our progress through a number of clinical and preclinical data sets in the second half of the year."

Upcoming Anticipated Milestones:

The Company plans to achieve the following key milestones in 2019:

Present clinical data from the Phase 1 study of MGTA-145
Present additional clinical data from the Phase 2 study of MGTA-456 in inherited metabolic disorders (IMDs)
Present preclinical data on anti-CD45 targeted conditioning program in autoimmune disease and declare a development candidate
Present preclinical data on anti-CD117 targeted conditioning program in gene therapy
Recent Business Highlights:

Initiated Phase 1 study of MGTA-145 as first-line stem cell mobilization therapy: In April 2019, Magenta announced that it had dosed the first subjects in a Phase 1 study of MGTA-145. Magenta intends to develop MGTA-145 in autoimmune diseases, blood cancers and genetic diseases. The Phase 1 study will investigate the safety and tolerability of MGTA-145 alone and in combination with plerixafor in healthy volunteers and establish recommended Phase 2 doses as well as measure the number of hematopoietic stem cells in the blood after dosing with MGTA-145 alone and in combination with plerixafor. Study enrollment is on track, and Magenta expects to present data from the study in the second half of 2019. Depending on the Phase 1 data, the Company plans to move MGTA-145 into a Phase 2 study in multiple myeloma and non-Hodgkin lymphoma in 2020.

Updated clinical data for MGTA-456 cell therapy showed continued signs of durable clinical benefit in patients with IMDs: Magenta presented updated data from the Phase 2 clinical study of MGTA-456 in patients with IMDs at the American Academy of Neurology (AAN) annual meeting in May 2019. Patients with cerebral adrenoleukodystrophy (cALD) treated with MGTA-456 in the study showed stable neurological function scores and persistent resolution of brain inflammation by MRI at 6 months post-transplant, suggesting that the progression of disease has been halted. Magenta expects to update longer term results in these patients in the second half of 2019.

Submitted multiple abstracts from across the pipeline to the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: Magenta submitted abstracts from across its conditioning, mobilization and cell therapy programs for presentation at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

Appointed Anne McGeorge to board of directors: In June 2019, Magenta announced that it had appointed Anne McGeorge to the board of directors and named her chair of the audit committee. Ms. McGeorge is an operating partner at Havencrest Healthcare Partners, a growth equity fund specializing in the healthcare industry, and is on the advisory board at Dioko Ventures, a healthcare venture fund, and is a member of the board of directors of The Be The Match Foundation and a member of the audit/finance committee of The National Marrow Donor Program, both of which are non-profit organizations dedicated to helping patients access life-saving stem cell transplants.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2019, were $172.3 million compared to $142.6 million on December 31, 2018. In addition, in May 2019 Magenta announced that it completed a public offering of common stock and raised net proceeds of $60.3 million. Magenta anticipates that its cash, cash equivalents and marketable securities, including the proceeds from this recent financing, will be sufficient to fund operations and capital expenditures into the second half of 2021.

Research and Development Expenses: Research and development (R&D) expenses were $13.4 million in the second quarter of 2019, compared to $9.7 million in the second quarter of 2018. The increase was driven primarily by investments in clinical activities for MGTA-145, as well as manufacturing related to our conditioning programs.

General and Administrative Expenses: General and administrative (G&A) expenses were $5.9 million for the second quarter of 2019, compared to $4.3 million for the second quarter in 2018. The increase was primarily due to increased personnel and facility costs associated with the growth of the Company.

Net Loss: Net loss was $17.7 million for the second quarter of 2019, compared to net loss of $13.7 million for the second quarter of 2018.

Kitov Pharma Reports First Half 2019 Financial Results and Provides Business Update

On August 8, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported financial results for the six-month period ended June 30, 2019 (Press release, Kitov Pharmaceuticals , AUG 8, 2019, View Source [SID1234538422]).

Key Financial Highlights for the first half of 2019:

Revenues of $1 million as a result of the first milestone payment from Coeptis Pharmaceuticals.
Decrease in research and development expenses to $1.7 million compared to $2.8 million in 1H18.
SG&A expenses of $3.3 million, similar to 1H18.
Net cash used in operating activities decreased to $2.3 million compared to $3.5 million in 1H18.
Net cash balance and short-term deposits at the end of 1H19 of $7.8 million, not including $3.5 million investment in Kitov by Orbimed, Pontifax and Arkin expected following completion of the FameWave acquisition.

Isaac Israel, chief executive officer of Kitov Pharma, commented, "During the first half of 2019, we made a great progress in the acquisition of FameWave announced earlier this year, with fulfillment of the major closing conditions including the clinical collaboration agreement signed with BMS. This acquisition of a clinical stage oncology asset is a major step in our shift towards an oncology focused company. With the recent successful completion of the IND-enabling studies to advance NT-219 into the clinic and the almost completed acquisition of CM-24, we will soon initiate clinical trials with both candidates which we believe have a great potential to provide effective and long-lasting treatments for patients."

Mr. Israel added, "We have additionally achieved significant milestones with Consensi during this period. With our plans to launch in the U.S., through our partnership with Coeptis Pharmaceuticals, we are already bringing additional revenues to support our oncology programs. The success of this program is also a reflection of our team’s ability to successfully execute end-to-end development of pharma products."

Key Research and Development Highlights

NT-219

NT-219 is a first-in-class small molecule dual inhibitor of STAT3 and IRS1/2, with the potential to prevent and overcome drug resistance in various cancer types when used in combination with existing agents. Key achievements for the NT-219 program for the six-month period ended June 30, 2019 include:

Completed IND-enabling studies to advance NT-219 for the treatment of patients with recurrent or metastatic head and neck cancers.
Planned Phase 1/2 open label multi-center study which will include a dose escalation with fewer than 20 patients and an expansion cohort with 30 patients, to investigate NT-219 in combination with cetuximab in patients with recurrent and metastatic squamous cell carcinoma of head & neck cancer (SCCHN). The main goal of the study is to evaluate the safety, tolerability and maximum tolerated dose, with a secondary endpoint to obtain preliminary efficacy data.
Announced new findings related to NT-219 mechanism of action showing that even a short exposure of cancerous cells to NT219 was sufficient to trigger irreversible shutdown of cancer pathways, resulting in a long-term anti-cancer effect. These new findings suggested that IRS1/2 dissociates from the cell membrane, undergoes serine phosphorylation which prevents rebinding to the receptor, and is finally degraded by the proteasome. This sequence of events leads to the blockage of PI3K – AKT pathway – a major cancer cell survival pathway.

CM-24

CM-24 is a clinical-stage monoclonal antibody antagonist of CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Kitov plans to develop CM-24 as a combination therapy with the PD-1 checkpoint inhibitor nivolumab (Opdivo) in clinical collaboration with Bristol-Myers-Squibb (BMS) to treat non-small cell lung cancer (NSCLC) patients. Key achievements for the CM-24 program for the six-month period ended June 30, 2019 include:

Announced signature of agreement to acquire FameWave Ltd., a privately held biopharmaceutical company developing CM-24.
Announced key milestone in the acquisition of FameWave, with the signature of a clinical collaboration agreement between FameWave and BMS for a Phase 1/2 clinical trials to evaluate the combination of CM-24 with nivolumab (Opdivo), BMS’s PD-1 inhibitor, in NSCLC.The safety profile of CM-24 was previously evaluated and found to be well tolerated in a Phase 1 study conducted by Merck at doses up to 10mg/kg.
Analysis of the Phase 1 data suggested that CEACAM-1 receptor saturation requires a higher dose of CM-24, which is expected be achieved with less than 20mg/kg if administrated every two weeks. Kitov believes that the combination of CM-24 with Opdivo is advantageous over Merck’s pembrolizumab (Keytruda) due to Opdivo’s Q2W administration protocol, compared to the Q3W administration protocol for Keytruda.
FameWave entered into a manufacturing agreement with its contract manufacturer for the production of CM-24 for the planned Phase 1/2 study.

Consensi

Consensi is a fixed-dose combination of celecoxib (Celebrex), a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc), a drug designed to treat hypertension. Consensi is under patent protection in the U.S. until 2030 and is the only NSAID whose labeling indicates a reduction of blood pressure and consequent risk reduction of heart attack, stroke, and death. Kitov plans to use revenue from milestone payments from multiple regional licensing deals for Consensi to advance its oncology pipeline. Key achievements for the Consensi program for the six-month period ended June 30, 2019 include:

Kitov signed an exclusive marketing and distribution agreement with Coeptis Pharmaceuticals for the U.S. market. The agreement provides for total milestone payments from Coeptis to Kitov of $3.5 million, of which Kitov has already received $1 million upon execution of the agreement. Additional milestone payments are due in the upcoming months upon completion of an agreed manufacturing plan and upon first commercial sales in the U.S. In addition, Kitov will be paid 40%-60% of Coeptis’ net profit on Consensi sales.

Expected Milestones for 2H19:

Submit IND for the initiation of Phase 1/2 study with NT-219 in combination with cetuximab in patients with recurrent and metastatic SCCHN.
Complete closing of transaction for the acquisition of FameWave and its CM-24 candidate
Complete preparation for launch of Consensi in the U.S. with commercial partner Coeptis Pharmaceuticals.
Submit marketing approval applications to the local regulatory authorities for potential registration of Consensi in China which will trigger an additional milestone payment to Kitov.

Financial Results for the Six-Month Period Ended June 30, 2019

Revenue for the six-month period ended June 30, 2019 was $1 million, resulting from a milestone payment from Coeptis related to Consensi in 2019, and same as in the first half of 2018 due to milestone payment from CSBio on Consensi in the first half of 2018.
Research and development expenses for the first half of the year ended June 30, 2019 were $1.7 million, a decrease of $1.1 million compared to the six-month period ended June 30, 2018. The decrease is mainly due to a reduction in clinical trials and regulatory expenses related to Consensi prior to its approval by the FDA in the first half of 2018, a decrease in bonuses accrued in the first half of 2018 in connection with FDA approval of Consensi as well as a decrease in ESOP costs in the first half of 2019 compared to the first half of 2018.
Selling, general and administrative expenses for the first half of the year ended June 30, 2019 were $3.3 million, compared to $3.4 million for the first half of year ended June 30, 2018.
Net cash used in operating activities was $2.3 million for the first half of the year ended June 30, 2019, compared to $3.5 million for the first half of year ended June 30, 2018. The decrease reflects a reduction of operating expenses of $1.2 million in the first half of 2019 compared to first half of 2018.
Kitov’s operating loss for the six-month period ended June 30, 2019 amounted to $3.6 million, compared with an operating loss of $4.4 million for the six-month period ended June 30, 2018. The decrease in operating loss reflects the decrease in operating expenses as mentioned above during 2019.
Kitov’s net loss for the six-month period ended June 30, 2019 amounted to $2.6 million, compared with a net loss of $5.2 million for the six-month period ended June 30, 2018. Basic and diluted loss per share in the first half of 2019 was 14 cents compared to 42 cents in the first half of 2018.
Cash, cash equivalents and short-term bank deposits totaled $7.8 million as of June 30, 2019. Upon closing of the FameWave acquisition, Kitov will receive an additional $3.5 million investment from Orbimed, Pontifax and Arkin.

Intrexon Reports Second Quarter and First Half 2019 Financial Results

On August 8, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its second quarter and first half financial results for 2019 (Press release, Intrexon, AUG 8, 2019, View Source [SID1234538421]).

Recent Business Highlights:

Precigen, Inc., a wholly owned subsidiary of Intrexon, announced the first patient dosed with PRGN-3005, an investigational autologous chimeric antigen receptor T (CAR-T) cell therapy developed using Precigen’s non-viral UltraCAR-T platform. PRGN-3005 UltraCAR-T therapy is under investigation for the treatment of patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (clinical trial identifier: NCT03907527);

Precigen, Inc., announced the first patient dosed with PRGN-3006, an investigational autologous CAR-T cell therapy developed using Precigen’s non-viral UltraCAR-T platform for the treatment of patients with relapsed or refractory acute myeloid leukemia or higher risk myelodysplastic syndrome (clinical trial identifier: NCT03927261);

Intrexon entered into an agreement under which it will contribute its Methane Bioconversion Platform, together with all its associated technologies and facilities, to MBP, LLC, a newly formed company that will be headed by David Dewhurst, who is purchasing equity capital in the venture;

Oxitec, Ltd., a wholly owned subsidiary of Intrexon, successfully completed the first pilot project of its 2nd Generation Friendly Aedes aegypti technology in Brazil, a mosquito strain that unlocks new performance features, greater cost-effectiveness and scalability over Oxitec’s 1st generation with limited production requirements. Oxitec’s new mosquitoes achieved excellent results in urban, dengue-prone environments, demonstrating its ability to achieve significant suppression with five times fewer mosquitoes. To pilot the technology in the US, Oxitec is working with the US Environmental Protection Agency (EPA) leadership on its Experimental Use Permit (EUP) in preparation for implementing a pilot project in 2020 in Florida;

ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon, announced that following a review by the independent Data and Safety Monitoring Board (DSMB) it will progress to the next stage of the Phase Ib/IIa clinical trial for investigational drug AG019 for the treatment of early onset type 1 diabetes (T1D). ActoBio Therapeutics has initiated enrollment of the next two patient cohorts of the study: AG019 dosing in patients 12-17 years of age and combination dosing of AG019 plus teplizumab in adults;

Triple-Gene LLC has proceeded to enrollment of the second cohort of the Phase 1 clinical trial of INXN-4001, an investigational new drug which is the world’s first triple effector gene drug candidate being evaluated for the treatment of heart failure, following review of the first cohort data by the DSMB;

Intrexon Laboratories Hungary and Surterra Wellness (Surterra) partnered in an exclusive global licensing agreement to advance Surterra’s cannabinoid production at a reliable, efficient, cost-effective, industrial scale utilizing Intrexon’s proprietary yeast fermentation platform. The deal, including milestones and royalties, will leverage each company’s expertise to ultimately bring new legal and ethical cannabinoid products to market to meet growing demand, boost innovation, and improve product development;

Intrexon announced it is advancing its non-browning GreenVenus Romaine lettuce to commercial-size production trials as initial data under commercial indoor production conditions indicate that it has improved shelf-life up to 2 weeks and a potential for higher marketable yield with no tip burn. Non-browning GreenVenus lettuce has also been assessed by the United States Department of Agriculture and determined not to be subject to regulation under 7CFR Part 340 for plants altered or produced through genetic engineering; and

Intrexon entered into a nonbinding letter of intent, and received a nonrefundable cash deposit, for the sale of Exemplar Genetics, a wholly owned subsidiary of Intrexon focused on developing miniature swine models of human disease. The transaction is expected to close within the next thirty days pending completion of diligence.

Second Quarter 2019 Financial Highlights:

Total revenues of $36.0 million;

Net loss of $38.8 million attributable to Intrexon, or $(0.25) per basic share, including non-cash charges of $8.0 million; and

Cash, cash equivalents, and short-term investments totaled $125.8 million and the value of common equity securities totaled $21.5 million at June 30, 2019.

First Half 2019 Financial Highlights:

Total revenues of $59.3 million;

Net loss of $99.5 million attributable to Intrexon, or $(0.65) per basic share, including non-cash charges of $28.2 million.

"Earlier this year we announced our intent to focus the Company’s business, directing capital to certain of our most strategic programs. We also established a goal of ending the year with approximately the same net cash and short-term investment position that the company held on April 3, 2019, which included initiating plans to sell or partner certain divisions and to reduce our original 2019 operating budget by approximately $70 million," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon.

Mr. Kirk concluded, "Based on the significant steps we have taken with respect to the sales of certain subsidiaries and assets, the partnering of programs, as well as operating cost reductions, we continue to believe our goal with respect to achieving the same net cash and short-term investment position should be achieved. Moreover, I believe we will meet this goal while retaining for the company the core technologies and valuable product candidates that represent the most important future value for our shareholders."

"We have identified and implemented significant operating cost reductions. However, based on progress to date and the ongoing evaluation of the Company’s strategic direction and long-term best interest, management has determined not to proceed in continuing its efforts to achieve the full initial target of $70 million in operating cost reductions. Instead, we will concentrate our focus on our overall net cash and short-term investment position," added LTG (Ret.) Thomas Bostick, PhD, PE, Chief Operating Officer of Intrexon and President, Intrexon Bioengineering.

There are risks and uncertainties inherent in forecasts of this nature, including with respect to the challenges in identifying and negotiating with counterparties, transactions taking longer or generating lower proceeds than expected, changes in strategic directions, general market developments, costs and expenses being higher than anticipated, developments in clinical, market or competitive data, and other factors of the type generally applicable to the Company’s business, including those discussed under the Safe Harbor Statement below.

With regard to the agreement to build a standalone energy company to be led by Governor Dewhurst on the foundation of Intrexon’s Methane Bioconversion Platform, Mr. Kirk further commented,

"Governor Dewhurst brings a lifetime of experience that perfectly suits him to lead the revolution in energy that should be made possible through our Methane Bioconversion Platform. From his experience as an intelligence officer, in public service (including serving as Lieutenant Governor of Texas for twelve years) and in building successful energy companies, he has throughout demonstrated leadership, intelligence, courage and personal integrity that inspire and that achieve significant results. We look forward to his leadership at MBP and to working with him to fully realize its great potential."

"As I have followed Intrexon, I have learned to admire and respect RJ’s acumen and visionary creation to improve the quality of life for all people. As an innovator, who has repeatedly implemented technologies successfully, I feel driven to seize this opportunity to work alongside RJ and the incredibly talented team as CEO of the Methanotroph Bioconversion Platform, to build a safer, healthier planet, and a more promising future. I’m excited by this opportunity and dedicated to bringing together great minds in synthetic biology with industry to solve big challenges facing today’s society," Governor Dewhurst stated.

Second Quarter 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $9.3 million from the quarter ended June 30, 2018. Collaboration and licensing revenues decreased $8.4 million, or 48%, from the quarter ended June 30, 2018 primarily due to the reacquisition of rights previously licensed to some of our most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations.

Research and development expenses decreased $7.5 million, or 18%. The 2018 amounts include $5.3 million of one-time costs associated with closing one of Oxitec’s research and development facilities as the Company decentralized operations previously conducted in this facility. Additionally, depreciation and amortization decreased $2.2 million primarily due to intangible assets that were impaired or abandoned in 2018. Selling, general and administrative (SG&A) expenses decreased $12.9 million, or 38% and of this amount, $10.6 million was primarily attributable to decreased share-based compensation expense which arose primarily from the departure of former employees.

First Half 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $25.6 million from the six months ended June 30, 2018. Collaboration and licensing revenues decreased $22.2 million, or 60%, from the six months ended June 30, 2018 primarily due to the reacquisition of rights previously licensed to some of our most significant collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Product revenues decreased $4.0 million, or 24%, primarily due to lower customer demand for pregnant cows, live and weaned calves, and cloned products. Gross margin on products declined in the current period as a result of fewer products sold, decreased sales prices, and increased costs associated with new product offerings.

Research and development expenses decreased $11.6 million, or 15%. The 2018 amounts include $5.3 million of one-time costs associated with closing one of Oxitec’s research and development facilities as the Company decentralized operations previously conducted in this facility. Additionally, depreciation and amortization decreased $4.3 million primarily due to intangible assets that were impaired or abandoned in 2018. Research and development salaries, benefits and other personnel costs decreased $2.0 million primarily due to the closing of one of Oxitec’s research and development facilities. SG&A expenses decreased $19.1 million, or 26% and of this amount, $15.5 million was primarily attributable to decreased share-based compensation expense which arose primarily from the departure of former employees.

Conference Call and Webcast

The Company will host a conference call today Thursday, August 8th, at 5:30 PM ET to discuss the second quarter and first half 2019 financial results and provide a general business update. The

conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 4443860 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

Idera Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2019 Financial Results

On August 8, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications, reported its operational and financial results for the second quarter ended June 30, 2019 (Press release, Idera Pharmaceuticals, AUG 8, 2019, View Source [SID1234538420]).

"Our team has demonstrated remarkable focus on execution during the first half of this year. We have made significant progress developing tilsotolimod and advancing it forward for patients facing the challenges of late-stage, anti-PD-1 refractory metastatic melanoma," stated Vincent Milano, Idera’s Chief Executive Officer. "Our accrual rate in the registrational ILLUMINATE-301 trial has exceeded our expectations, which is reflective of the high unmet need in this patient population."

Milano continued, "Additionally, we are providing data from the ILLUMINATE-204 trial, which we believe is informative as to the probability of success in the registrational trial. We also are advancing toward initiation of our first combination therapy trial in areas beyond melanoma, ILLUMINATE-206, which we expect will provide additional opportunities and milestones for data updates next year."

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 — Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:

· Overall Response Rate (ORR) and Overall Survival (OS) as family of primary endpoints;

· Trial initiated in the first quarter of 2018;

· Sites active in 11 countries: Approximately 100 sites participating.

Based on feedback from the ILLUMINATE-301 steering committee and global melanoma and immunology experts, we have elected to make the following modifications to the ILLUMINATE 301 trial design:

· Median OS improvement over ipilimumab alone of greater than or equal to 4.6 months from prior delta of improvement of 6.6 months;

· ORR improvement of 10 percentage points over ipilimumab alone from prior delta of improvement of 20 percentage points;

· Target effect size/hazard ratio adjusted to 0.71 from 0.63; resulting in a planned enrollment of approximately 450 patients from 308, of which 294 are currently enrolled; and

·Targeting completion of enrollment during the first half of 2020.

We along with our collaboration partner, BMS, have amended the prior Clinical Trial Collaboration and Supply Agreement to accommodate the increase in supply of ipilimumab for the ILLUMINATE-301 trial.

Additionally, we have solicited feedback from the U.S. Food and Drug Administration and they do not object to these changes. We also have solicited feedback from other global health authorities related to these changes.

ILLUMINATE 204 — Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

· Completed enrollment with 52 patients at tilsotolimod 8 mg with ipilimumab in February 2019;

· Data as of August 5, 2019 on endpoints:

·27% ORR (n=13) of the 49 patients evaluable for efficacy; 74% (36) achieving disease control (best response of CR, PR or Stable Disease (SD));

· Durable responses (>6 mos.) observed in 8 of 13 responders;

· Median OS has not yet been reached (min/max: 1.6 mos. — 35 mos.);

· The safety profile observed in this analysis was consistent with previously reported results, with no emergence of new safety signals;

· 43% (n=21) of patients enrolled into trial presented at baseline with Eastern Cooperative Oncology Group (ECOG) performance status 2; and

· Final results from the ILLUMINATE 204 trial are expected to be submitted for an abstract at a medical conference during the first half of 2020.

ILLUMINATE 206 — Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

· On March 11, 2019, we entered into a second clinical trial collaboration with BMS in which BMS has agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO (nivolumab) for no charge for use in ILLUMINATE-206;

· Trial expected to initiate in the third quarter of 2019 beginning with the MSS-CRC cohort.

ILLUMINATE 101 — Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:

· Completed enrollment in all dose cohorts of the trial;

· Initial data presented at American Academy for Cancer Research (AACR) (Free AACR Whitepaper) 2019 conference;

·Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;

·One patient with uterine leiomyosarcoma has been on tilsotolimod treatment for more than a year with durable stable disease and is continuing under a treatment investigational new drug;

· One patient in the melanoma cohort achieved an unconfirmed RECIST v.1.1 partial response (PR) with 35% tumor shrinkage in the target lesion; and

· Abstract submission accepted for poster presentation at the European Society for Medical Oncology 2019 Conference being held in Barcelona, Spain in September 2019.

Corporate Updates:

·Elizabeth A. Tarka, MD, FACC was appointed as Chief Medical Officer effective July 22, 2019; and

· John J. Kirby was appointed as Chief Financial Officer effective July 22, 2019.

Upcoming Investor Presentation:

· The company will be presenting at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019 at 1:20 PM ET. The conference is being held at the Parker New York Hotel. The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com.

Financial Results

Second Quarter Results

Net loss applicable to common stockholders for the three months ended June 30, 2019 was $11.2 million, or $0.39 per basic and diluted share, compared to net loss applicable to common stockholders of $16.0 million, or $0.59 per basic and diluted share, for the same period in 2018. Revenue for the three months ended June 30, 2019 was $1.4 million, compared to $0.2 million for the same period in 2018. Research and development expenses for the three months ended June 30, 2019 totaled $10.0 million compared to $10.9 million for the same period in 2018. General and administrative expense for the three months ended June 30, 2019 totaled $2.9 million compared to $4.0 million for the same period in 2018. Merger-related costs, net for the three months ended June 30, 2018 totaled $1.6 million and related to our contemplated merger transaction. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended June 30, 2019 were nominal and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred for the same period in 2018.

As of June 30, 2019, our cash, cash equivalents and short-term investments totaled $52.4 million compared to $71.4 million as of December 31, 2018. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2020.

Investor Event and Webcast

Idera will host a conference call and live webcast today, Thursday, August 8, 2019, at 10:00 A.M. EST to provide an overview of today’s update along with a question and answer session. To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com.

Eagle Pharmaceuticals, Inc. Reports Second Quarter 2019 Results

On August 8, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three- and six-months ended June 30, 2019 (Press release, Eagle Pharmaceuticals, AUG 8, 2019, View Source [SID1234538419]). Highlights of, and subsequent to, the second quarter of 2019 include:

Business and Financial Highlights:

On August 5, 2019, Eagle announced a clinical development plan, following guidance from the U.S. Food and Drug Administration (FDA), for its fulvestrant formulation, intended to deliver maximum estrogen receptor inhibition in patients with estrogen receptor (ER)-positive breast cancer:
Eagle plans to initiate a pilot study shortly
Once the pilot study results are reviewed, a clinical pivotal trial based upon the parameters determined with FDA will be conducted in a target patient population
The pivotal trial is expected to be completed within approximately 12 months of commencing enrollment
The Company’s mid- and late-stage pipeline programs are on track;
Total revenue for the second quarter of 2019 was $56.7 million, compared to $59.3 million in the second quarter of 2018;
Q2 2019 BELRAPZO product sales were $15.4 million, compared to $8.1 million in Q2 2018;
Q2 2019 RYANODEX product sales were $2.9 million, compared to $7.2 million in Q2 2018;
Q2 2019 net income was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in Q2 2018;
Q2 2019 adjusted non-GAAP net income was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.7 million, or $0.99 per basic and $0.95 per diluted share in Q2 2018;
During Q2 2019, Eagle purchased an additional $15.0 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $168.9 million of Eagle common stock; and
Cash and cash equivalents were $108.1 million, net accounts receivable was $60.3 million, and debt was $41.3 million as of June 30, 2019.
"We had another strong quarter; earnings from our bendamustine portfolio have established a solid platform from which to advance our R&D programs and explore additional opportunities to add to our portfolio. Our fulvestrant program looks very promising and we believe our novel formulation has a unique profile that may lead to improved efficacy outcomes for breast cancer patients. With guidance from FDA, we plan to conduct a pilot study shortly followed by a pivotal trial to test our hypothesis," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"Moreover, we continue to advance the other assets in our portfolio. We are in discussions with the U.S. military regarding treatment of radiation syndrome, and we also plan to request a meeting with FDA shortly to discuss the regulatory path for our nerve agent indication. We continue to advance EA-111, our intramuscular version of dantrolene," added Tarriff.

"With these initiatives underway, and our pemfexy and vasopressin litigations proceeding as anticipated, we believe we are closer than ever before to unlocking the significant value of the multiple assets in our pipeline. We intend to continue to invest in our research and development programs and align our resources to support the successful launch of our assets, once approved," concluded Tarriff.

Second Quarter 2019 Financial Results

Total revenue for the three months ended June 30, 2019 was $56.7 million, as compared to $59.3 million for the three months ended June 30, 2018.

Royalty revenue was $27.3 million in the second quarter of 2019, compared to $36.3 million in the second quarter of 2018. BENDEKA royalties were $26.5 million in the second quarter of 2019, compared to $34.7 million in the second quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 62% during the second quarter of 2019, as compared to 69% in the second quarter of 2018. The compression in gross margin in the second quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit.

R&D expense was $9.0 million for the quarter, compared to $15.3 million in the same quarter in the prior year. The second quarter year over year decrease reflects a substantial reduction in fulvestrant expense, partially offset by the cost to bring vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter was $7.8 million.

SG&A expense in the second quarter of 2019 increased to $17.2 million compared to $16.0 million in the second quarter of 2018. External legal spend associated with litigation on PEMFEXY, vasopressin and bendamustine and higher stock compensation expense account for the year over year increase. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2019 SG&A expense was $12.4 million.

Net income for the second quarter of 2019 was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in the second quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2019 was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to Adjusted non-GAAP net income of $14.7 million or $0.99 per basic and $0.95 per diluted share in the second quarter of 2018. 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.

2019 Expense Guidance

R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.
SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.
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, 2019, the Company had $108.1 million in cash and cash equivalents and $60.3 million in net accounts receivable, $37.6 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $41.3 million in outstanding debt. Therefore, at June 30, 2019, the Company had net cash and receivables of $127.2 million.

In the second quarter of 2019, we purchased $15.0 million of Eagle’s common stock as part of our share buyback program. Since August 2016, we have repurchased $168.9 million of our common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2019 conference call as follows:

Date

Thursday, August 8, 2019

Time

8:30 A.M. EDT

Toll free (U.S.)

877-876-9173

International 785-424-1667
Webcast (live and replay) www.eagleus.com, under the "Investor + News" section
A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-5685 (US) or 402-220-2567 (International) and entering conference call ID EGRXQ219. The webcast will be archived for 30 days at the aforementioned URL.