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]).

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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

On August 8, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported it has developed a method to quantify the active ingredients of Propanc’s lead product candidate, PRP, in preparation for the company’s First-In-Human ("FIH") study, planned for early 2020 (Press release, Propanc, AUG 8, 2019, View Source [SID1234538437]). The work was conducted by Propanc’s research partner based in Berlin, Germany, who has extensive experience in the development of functional assays for unique bio-therapeutics. This bioanalytical method development and validation plays a significant role in evaluation and interpretation of the systemic absorption of PRP in clinical studies including its distribution, and clinical effects throughout the body.

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PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen, administered by intravenous injection. The naturally derived proenzymes are very large and complex protein structures that can be broken down into different fragments that can be difficult to separate and analyze from human serum. The remarkable achievement to identify and develop a suitable method to measure four key analytes from PRP, the two proenzymes, trypsinogen and chymotrypsinogen, as well as the activated enzymes, trypsin and chymotrypsin, is particularly significant due to the close structural similarity of each protein structure. By using a highly sensitive detection system like Liquid Chromatography/Mass Spectrometry, a suitable method was developed that could separate, identify and quantify all four analytes. Moreover, a strong correlation between the concentration and signal intensity was established with a R2 = 0.9996, where 1.0000 represents a linear, straight line, indicating a direct correlation between the two variables measured. This is especially important when measuring the concentration of the analytes within a certain range over time, providing valuable information regarding dosing and the clinical effects of a drug, like PRP, when administered to patients. Lower limits of quantification and detection were also established.

"This is an important step for the advancement of PRP towards commencing our First-In-Human study. Understanding clinical effects and their relationship to the concentration of the drug over time is especially important so that we can optimize dosing of PRP when administered to patients," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer. "We think measuring all four analytes, the two proenzymes and their activated enzymes is critical, because it is the activated enzymes which exert their effects on cancerous cells, so this will provide an important link to the action of PRP and its clinical effects."

The development of the bioanalytical assay is also an important step for the clinical development of PRP, as Propanc evaluates sites to conduct the FIH study in advanced cancer patients, such as the Peter Mac Center, Australia’s largest cancer hospital, which has significant experience in early stage clinical development. Propanc is evaluating Australia as a potential destination where it may commence the Phase Ib clinical trial because of its research and development tax incentives, as well as a simplified regulatory environment. As part of such incentives, eligible companies conducting clinical trials in Australia may receive up to 43.5% "cash-back" benefit in the form of a refund of their qualified research and development costs and expenses.

"Since we have completed the development of bioanalytical assay and are commencing the pre-validation stage, we look forward to presenting the data package in the near future to the Director at the Peter Mac Center, Parkville Cancer Clinical Trials Unit, and his investigators, to discuss further details about the upcoming FIH study," said Professor Klaus Kutz, Propanc’s acting Chief Medical Officer.

On August 8, 2019 -Bicycle Therapeutics plc, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycles) product platform, reported financial results for the second quarter ended June 30, 2019 and provided a clinical update (Press release, Bicycle Therapeutics, AUG 8, 2019, View Source [SID1234538455]).

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"The second quarter of this year was marked by the completion of our initial public offering, placing us in a solid financial position to advance our novel pipeline of Bicycle drug candidates through the clinic," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased with the progress that our pipeline has made over the last quarter, including BT1718, which continues to progress in Phase I dose escalation. We believe that Bicycles, because of their low molecular weight and high affinity and selectivity, could provide meaningful efficacy to patients suffering from cancer and could avoid the toxicities associated with other classes of highly potent anti-cancer drugs, and we look forward to providing updates on our progress."

Second Quarter 2019 and Recent Highlights

Provided Update on the Phase I/IIa Trial Evaluating Lead Asset BT1718 in Patients with Advanced Solid Tumors. Today, Bicycle announced that in the 25 mg/m2 once weekly cohort, no dose limiting toxicities were observed, and the decision was made to continue with dose escalation.
Announced Changes to the Board of Directors. In July 2019, Bicycle announced changes to the composition of its Board of Directors, including the appointment of pharmaceutical industry veteran Richard N. Kender and life sciences financing professional Janice Bourque, as well as an orderly transition for four board members to depart over the next twelve months, which will result in a reduction of the Company’s board size while enhancing its scientific and U.S. public company board expertise.
Announced Positive Topline Results from Oxurion’s Phase I Trial Using Novel Bicycle-based Plasma Kallikrein Inhibitor for the Treatment of Diabetic Macular Edema. In July 2019, Bicycle announced the successful completion of Oxurion’s Phase I clinical trial evaluating the safety and tolerability of a single intravitreal injection of THR-149, a novel Bicycle-based plasma kallikrein (PKal) inhibitor, in patients with diabetic macular edema (DME). No dose-limiting toxicities or drug-related adverse events were reported. A rapid onset of action was observed from Day 1, with an increasing average improvement in patients’ best corrected visual acuity (BCVA) of up to 7.5 letters at Day 14. This activity was maintained with an average improvement in BCVA of 6.5 letters at Day 90 following the single injection.
Completed Initial Public Offering. In May 2019, Bicycle completed its initial public offering (IPO) of 4,637,666 American Depositary Shares (ADSs), which included a partial exercise of the underwriters’ option to purchase additional ADSs, at $14.00 per ADS, for gross proceeds of $64.9 million, before deducting underwriting discounts, commissions and offering expenses.
Entered Collaboration with Dementia Discovery Fund. In May 2019, Bicycle announced its collaboration with the Dementia Discovery Fund (DDF), which allows the organization to use Bicycle technology for the development of novel therapeutics for neurodegenerative diseases. Under the terms of the agreement, Bicycle will identify Bicycles that bind to genetically-validated dementia targets. If promising lead compounds are identified, Bicycle will own the resulting IP and, with DDF, have the option to jointly establish a new company to develop those compounds.
Strengthened Clinical Team to Advance Expanding Pipeline. In May 2019, Bicycle announced two senior appointments to help expand the Company’s clinical pipeline. Lisa Mahnke, M.D., Ph.D., joined as Senior Vice President and Head of Clinical and Terrence West, MBA, joined as Vice President and Head of Program Management. Dr. Mahnke was recently VP, Head of Clinical Development at Syros Pharmaceuticals and previously served at EMD Serono. Mr. West was previously Executive Director, Project Management, at EMD Serono.
Financial Results

Cash and cash equivalents were $108.5 million as of June 30, 2019, compared with $63.4 million as of December 31, 2018. In the second quarter of 2019, Bicycle completed its IPO for gross proceeds of $64.9 million, before deducting underwriting discounts, commissions and offering expenses.
Collaboration revenues were $1.5 million for the three months ended June 30, 2019 compared to $1.7 million for the three months ended June 30, 2018. The change in revenue includes $1.1 million of revenue recognized from new collaboration activities in Q2 2019, offset by a decrease in Sanofi revenue.
Research and development expenses totaled $6.5 million for the three months ended June 30, 2019, compared to $4.9 million for the three months ended June 30, 2018. The increase of $1.6 million is primarily due to a $2.5 million increase in direct program related spending and personnel related expenses, offset by an increase in research and development tax credit reimbursement of $0.9 million.
General and administrative expenses were $3.0 million for the three months ended June 30, 2019, compared to $1.7 million for the three months ended June 30, 2018. The increase was largely due to increased personnel costs associated with the growth of the Company and professional fees related to operations as a public company.
Net loss was $10.2 million, or $(1.40) basic and diluted net loss per share, for the three months ended June 30, 2019, compared to net loss of $5.0 million, or $(11.85) basic diluted net income per share, for the three months ended June 30, 2018.

On August 8, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, AUG 8, 2019, View Source [SID1234538471]).

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"Eiger is advancing a late stage pipeline with three breakthrough therapy designations towards key milestones in 2019, including submission of the first ever NDA and MAA for Progeria and Progeroid Laminopathies," said David Cory, Eiger President and Chief Executive Officer. "In addition, enrollment of D-LIVR, the first-ever international Phase 3 study in Hepatitis Delta Virus infection, is ongoing, and we expect FDA registration guidance on our Lambda and Avexitide programs by year end. Eiger is poised for future growth."

Recent Highlights

Peginterferon Lambda (Lambda) in Hepatitis D Virus (HDV)

Positive Phase 2 LIMT (Lambda mono therapy) study results (N=33): 36% durable virologic response at 24 weeks post-treatment reported at The International Liver Congress 2019
Avexitide in Post-Bariatric Hypoglycemia (PBH) Program

Breakthrough Therapy Designation granted by FDA
Corporate Activity

Mark Mannebach, PhD, RPh, appointed as Vice President, Global Regulatory Affairs
Jeysen Yogaratnam, MB.BCh, BAO, MRCSEd, PhD, MBA, appointed as Vice President, Global HDV Clinical Development
Anticipated 2019 Milestones

FDA Guidance for Avexitide in PBH
Phase 2 LIFT (Lambda combination therapy with Lonafarnib and Ritonavir) end-of-treatment study results in HDV at AASLD
End of Phase 2 meeting for Lambda in HDV
NDA and MAA submissions in Progeria and Progeroid Laminopathies in Q4 2019
Phase 3 D-LIVR study in HDV (N=400) enrollment update
Second Quarter 2019 Financial Results

Cash, cash equivalents, and short-term investments as of June 30, 2019 totaled $125.3 million compared to $85.8 million at March 31, 2019, an increase of $39.5 million.

The Company reported net losses of $17.5 million, or $0.75 per share for second quarter 2019, as compared to $9.9 million, or $0.82 per share, for the same period in 2018.

Research and Development expenses were $12.9 million for second quarter 2019, as compared to $6.4 million for the same period in 2018, an increase of $6.5 million. The increase was primarily due to expenditures related to our clinical programs and licenses and other fees.

General and Administrative expenses were $4.2 million for second quarter 2019, as compared to $3.2 million for the same period in 2018, an increase of $1.0 million. The increase was primarily due to additional employee-related costs, including stock-based compensation, and external professional services as Eiger continued to build its infrastructure to support the development and potential commercialization of its clinical programs.

Second quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.4 million for the same period in 2018.

In April 2019, Eiger completed a public offering of 5,175,000 shares of its common stock, including 675,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock, at a price of $11.00 per share. The offering was made under Eiger’s effective shelf registration statement and resulted in net proceeds to the company of approximately $53.2 million, after deducting underwriting discounts and commissions and offering expenses.

As of June 30, 2019, Eiger had 24.4 million of common shares outstanding.

On August 8, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, reported its financial results for the second quarter ended June 30, 2019, and provided an update on the Company’s recent activities (Press release, Ziopharm, AUG 8, 2019, View Source [SID1234538390]).

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"We have made significant advancements in our programs during the second quarter. The FDA cleared the IND for the first non-viral, neoantigen-specific TCR-T cell therapy at the NCI using our Sleeping Beauty system and we announced an exclusive license to an expansive library of TCRs against neoantigens in three of the most important hotspot families," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "In our Controlled IL-12 program, we completed enrollment of the third dosing cohort in our phase 1 combination trial with nivolumab and initiated a phase 2 combination trial with Regeneron’s Libtayo. Finally, we refined our plans for the third-generation Sleeping Beauty CD19-specific CAR-T phase 1 trial at MD Anderson Cancer Center, which we continue to expect to commence later this year."

David Mauney, M.D., President of Ziopharm, added, "As our clinical programs continue to advance, we have strengthened our balance sheet and expanded the breadth and depth of our corporate leadership. We are proud to welcome Sath Shukla and Dr. Drew Deniger to our leadership team and Heidi Hagen to our Board of Directors. We are grateful that through the support of key shareholders who exercised their existing warrants several years prior to expiration, we added $45 million to our treasury to provide us with cash into the first half of 2021, which we expect will allow us to see data readouts in the three programs."

Corporate Updates

Since the beginning of the second quarter, Ziopharm has announced positive corporate developments regarding expansion of the management team and strengthening of the company’s balance sheet.

Balance sheet strengthened with $45 million: A group of Ziopharm shareholders, led by MSD Partners, L.P., exercised their existing warrants to purchase common stock, which resulted in gross proceeds of approximately $45 million. We expect this additional capital is sufficient to fund operations into 2021 and provide visibility into important clinical data milestones for Ziopharm’s TCR-T, CAR-T and Controlled IL-12 programs.

Sath Shukla named CFO: With 20 years of strategic corporate and financial leadership experience, Mr. Shukla joins as Chief Financial Officer from Vertex Pharmaceuticals, where he was most recently Vice President and global Head of Corporate Finance, directing financial planning, analysis and budgeting, and leading the annual long-range planning process encompassing Vertex’s entire portfolio and operations across more than 30 countries.

NCI’s Dr. Drew Deniger to Direct TCR-T Cell Therapy Program: In early July, Ziopharm announced that Dr. Deniger was hired from the NCI to lead Ziopharm’s non-viral T-cell program targeting neoantigens for personalized immunotherapy of solid tumors. Dr. Deniger worked under Dr. Steven Rosenberg at the NCI and is a recognized leader in the identification of TCRs targeting neoantigens. Dr. Deniger has a track record of helping to advance innovative immunotherapy approaches into the clinic and has years of expertise with the Sleeping Beauty system.

Heidi Hagen joins Board of Directors: In June, Ziopharm appointed Heidi Hagen, an experienced and entrepreneurial biotechnology operations executive, to the Company’s board of directors. The addition of Ms. Hagen represented the fifth new board member for Ziopharm in the past year.

Program Updates

Sleeping Beauty TCR-T Therapies

The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is initiating a clinical trial to treat patients with metastatic/advanced solid tumors using the Company’s Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.

FDA Clearance of IND for Sleeping Beauty TCR-T cell therapy: In June, Ziopharm announced that the investigational new drug (IND) application submitted by the NCI had received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate TCR T-cell therapy utilizing Ziopharm’s Sleeping Beauty platform. Under the direction of Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, and his team, the site is completing the internal processes for enrollment, while working to detect neoantigens to be targeted, isolating the TCRs and identifying patients for the trial.

Exclusive License with NCI to Identify and Use TCRs Targeting Neoantigens for Cancer with Sleeping Beauty Platform: In May, Ziopharm announced an exclusive license agreement with NCI for intellectual property for the development and commercialization of cell therapies for cancer. The scope of the license includes a library of TCRs against neoantigens in hotspots including mutated KRAS, p53 and EGFR for use with transposons. The license also includes technologies to enhance manufacturing capabilities for clinical-grade T cells (referred to as TCR-T) through the Sleeping Beauty platform.

Sleeping Beauty CAR-T Therapies

Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CAR-T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, enabling T cells to be infused within two days after genetic modification. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.

Third-generation phase 1 trial for RPM of Sleeping Beauty CD19-specific CAR-T with mbIL15 expected to begin later this year: The Company anticipates beginning a phase 1 trial at MD Anderson Cancer Center in the second half of this year, leveraging the Company’s RPM to produce T cells in two days or less after gene transfer. The Company has prioritized a new clinical trial infusing donor-derived allogeneic RPM CAR-T in patients who relapse after bone marrow transplantation to complement its autologous efforts targeting CD19, thereby providing a suite of CAR-T technologies to address the continuum of patients with refractory CD19+ malignancies.

Eden BioCell to advance third-generation Sleeping Beauty CD19-specific CAR-T for Greater China: With TriArm Therapeutics, a Panacea Venture Healthcare backed company, Eden BioCell was formed as a joint venture to develop and commercialize Sleeping Beauty-generated CD19-specific CAR-T in Greater China using the RPM technology. Recruitment of staff and buildout of facilities is accelerating, and the Eden BioCell team has begun meetings with potential hospital sites and their clinical teams.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as a monotherapy and in combination with immune checkpoint inhibitors.

Enrollment completed in third cohort of combination study with OPDIVO (nivolumab): Ziopharm announced in June that it had completed enrollment in three dosing cohorts in its phase 1 study of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO, an immune checkpoint inhibitor against programmed death-1 (PD-1). Based on a favorable safety profile, investigators from this multi-center trial indicated interest in expanding the study and the Company now expects to enroll up to 12 additional patients at the highest dosing level.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) initiated in June: The Company, in collaboration with Regeneron Pharmaceuticals, initiated a phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo to treat patients with rGBM. Enrollment for this study has commenced, as the Company expects to enroll about 30 patients at approximately 10 sites.

Positive clinical data presented at 2019 ASCO (Free ASCO Whitepaper) Annual Meeting: New interim analyses of clinical data from two ongoing substudies in its Controlled IL-12 platform, both as monotherapy and in combination with OPDIVO, were presented at ASCO (Free ASCO Whitepaper) in June. Additional updates are expected later this year.

FDA grants Fast Track status to Controlled IL-12 program: Ziopharm announced in April that FDA granted Fast Track designation for its Controlled IL-12 program for the treatment of rGBM in adults.

Second Quarter 2019 Financial Results

Net loss applicable to the common shareholders for the second quarter of 2019 was $14.6 million, or $(0.09) per share, compared to a net loss of $17.5 million, or $(0.12) per share, for the second quarter of 2018. The change in net loss to common shareholders resulted primarily from the elimination of approximately $5.5 million of dividends to preferred shareholders caused by the forfeiture and return of all of the Company’s Series 1 preferred stock in October 2018, along with the changes in research and development expenses and general and administrative expenses noted below.

Research and development expenses were $10.0 million for the second quarter of 2019, compared to $7.5 million for the second quarter of 2018. The increase in research and development expenses for the three months ended June 30, 2019 is primarily due to milestone costs under our patent license agreement with the NCI and increased nonclinical research and development to support our Cell Therapy programs. For additional context, research and development expenses in the first quarter of 2019 were $9.5 million.

General and administrative expenses were $4.8 million for the second quarter of 2019, compared to $4.9 million for the second quarter of 2018. For additional context, general and administrative expenses in the first quarter of 2019 were $4.1 million.

The Company ended the quarter with unrestricted cash resources of approximately $43.6 million.

In addition, a prepayment of approximately $24.2 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

As announced on July 29, 2019, the company raised approximately $45 million through the exercise of existing warrants. The Company believes its current resources will be sufficient to fund its planned operations into the first half of 2021.

Conference Call and Webcast

The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8279471. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.