On August 14, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), today provided a corporate update and reported financial results for the second quarter ended June 30, 2019.

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!

Steven M. Fruchtman, M.D., President and Chief Executive Officer, stated, "Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. Our goal is to complete enrollment by the end of 2019 and we anticipate reporting top-line data in the first half of 2020 following full enrollment and 288 death events. If the INSPIRE Trial is successful, we believe rigosertib could be the first new treatment for higher-risk MDS in more than 15 years, and based on its unique mechanism of action, has the potential to provide clinical benefit in other Ras mutated cancers."

Dr. Fruchtman continued, "In addition to advancing the INSPIRE Trial, our Special Protocol Assessment (SPA) request to the FDA for a Phase 3 combination trial of oral rigosertib plus azacitidine in first-line higher-risk MDS patients is being pursued. We also have plans to target cancers driven by mutated Ras genes. Ras-mutated cancers represent about a third of all human cancers, and a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence in 2019 as an investigator-initiated study. We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational, first-in-class, dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer."

Second Quarter 2019 and Recent Highlights

On March 25, the Company announced that it had passed the 75 percent enrollment mark in the Phase 3 INSPIRE Trial. Onconova remains focused on our primary goal of completing enrollment by the end of 2019 and expects to report top-line survival data following full enrollment and 288 death events.

• More than 140 trial sites in 24 countries across four continents are open, including 21 sites in Japan. The Company opened new clinical trial sites in already participating countries. Additional geographies, including Brazil, are being opened during the coming months to add approximately 25 more sites. This strategy is designed to support the goal of achieving full accrual to the INSPIRE Trial in 2019. The Company anticipates reporting top-line data in the first half of 2020 following full enrollment and 288 death events.
The Company entered into a license agreement with HanX Biopharmaceuticals (HanX) for the development and commercialization of rigosertib in Greater China. The agreement provides for $4 million of upfront payments to Onconova, including a $2 million cash upfront fee and an investment totaling $2 million in shares purchased at a premium to market. In addition, HanX agreed to place $2 million in escrow in local currency for rigosertib clinical development expenses in Greater China. HanX will make additional regulatory, developmental, and sales-based milestone payments to Onconova of up to $45.5 million and will pay Onconova tiered royalties up to double digits on net sales in Greater China. If approval is received, Onconova will supply rigosertib to HanX for development and commercialization. HanX also will support Onconova’s other clinical trial initiatives in Greater China.
Onconova and Mission Bio have entered into a collaboration to utilize the Mission Bio Tapestri Platform for targeted single-cell DNA analysis to study rigosertib as part of planned clinical trials. Single-cell genomics may identify mutations with far better resolution than that of traditional sequencing methods, allowing a view into each patient’s disease at a level never before achieved. Tapestri will be utilized to identify mutations, including those of the Ras pathway, to monitor a patient’s response in clinical trials, supporting the advancement of rigosertib. By adding the Tapestri Platform to its research and development program, Onconova is including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes.

In December 2018, Onconova applied to the FDA for a Special Protocol Assessment (SPA) for a Phase 3 trial of oral rigosertib in combination with azacitidine for treatment of first-line higher-risk MDS patients. The Company expects completion of the FDA’s SPA decision before the end of 2019.

Results from the Phase 2 trial were reported in December 2018 in an oral presentation at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting and updated at the 2019 European Hematology Association (EHA) (Free EHA Whitepaper) Meeting.
Additional Progress for Rigosertib and Pipeline Products

ON 123300, an investigational first-in-class dual inhibitor of CDK4/6 + ARK5 with the potential to treat a variety of cancers, continues to make progress toward clinical development in the U.S. and China in partnership with HanX. HanX has conducted toxicology studies to support an IND filing in the U.S.

The collaboration with the National Cancer Institute as well as one with a Center of Excellence in Juvenile Myelomonocytic Leukemia, or JMML, for preclinical studies of rigosertib for treatment of pediatric cancer associated RASopathies are ongoing.

Onconova continues to participate in important medical and investment conferences. During the second quarter, presentations related to rigosertib development and clinical trials were made at:
• 15th Annual International Symposium on MDS/Copenhagen
• Acute Leukemia Forum/Shanghai
• BIO International Forum/Philadelphia
• European Hematology Association (EHA) (Free EHA Whitepaper)/Amsterdam
Upcoming 2019 conferences include:

RAS-Targeted Drug Discovery Summit (Boston, September 17-19)
Brazilian Association of Hematology, Hemotherapy and Cellular Therapy Congress (Rio de Janeiro, November 6-9)
The American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in (Orlando, December 7-10)
Second Quarter 2019 Financial Results

Cash and cash equivalents as of June 30, 2019, totaled $5.9 million compared to $17.0 million at December 31, 2018. The Company believes that cash and cash equivalents at June 30, 2019, along with additional funds to be received from the HanX license in the third quarter, will be sufficient to fund ongoing trials and operations late into the fourth quarter of 2019. The Company was notified by Nasdaq on July 26 that Nasdaq has accepted the Company’s plan to regain compliance with the stockholders’ equity listing requirement by November 18, 2019.

Net loss was $3.6 million for the quarter ended June 30, 2019, compared to $4.3 million for the second quarter ended June 30, 2018. Research and development expenses were $3.9 million for the quarter ended June 30, 2019, and $4.1 million for the comparable period in 2018. General and administrative expenses were $1.8 million for the quarter ended June 30, 2019, and $2.1 million for the comparable period in 2018.

Conference Call and Webcast Information

The Company will host a conference call today, August 14, 2019, at 9 a.m. Eastern Time, to provide a corporate update and discuss second quarter 2019 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID 90141175. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.

On August 14, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, provides an update to confirm that its previously reported underwritten public offering of USD $3.7M (CDN $4.9M) was priced at USD $0.81 (CDN $1.07) (Press release, Oncolytics Biotech, AUG 14, 2019, View Source [SID1234538764]).

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!

All other details of the previous release are correct and copied below:

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the pricing of its previously announced underwritten public offering (the "Offering") of 4,619,773 common shares and warrants to purchase up to 4,619,773 common shares at a combined public offering price of $0.81 per share and warrant, resulting in gross proceeds of approximately USD 3.7M. Each warrant has an exercise price of $0.90 per common share, is exercisable immediately and will expire 5 years from the date of issuance. The common shares and the accompanying warrants can only be purchased together in this Offering but will be issued separately.

The Offering is expected to close on or about August 16, 2019, subject to the satisfaction of customary closing conditions. Oncolytics has also granted to the underwriter a 30-day option to purchase up to an additional 692,965 common shares and/or warrants to purchase up to 692,965 common shares, at the public offering price per common share and warrant, less underwriter discounts and commissions. The Offering is subject to customary closing conditions, including Nasdaq and TSX approvals.

The Company intends to use the net proceeds of this Offering for research and development activities and working capital purposes.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), is acting as the sole book-running manager in connection with the Offering.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on May 7, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated May 4, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the Alberta Securities Commission in Canada, and with the SEC in the United States. No common shares or warrants will be offered or sold to Canadian purchasers. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov. Alternatively, when available, copies of the final prospectus supplement can also be obtained from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 14, 2019 Heat Biologics, Inc. (Nasdaq:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2019 (Press release, Heat Biologics, AUG 14, 2019, View Source [SID1234538761]).

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!

Jeff Wolf, Heat’s CEO, commented, "We recently announced that we completed recruitment for our Phase 2 clinical trial investigating HS-110 for advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) or with Merck’s KEYTRUDA (pembrolizumab) with approximately 120 patients enrolled in the trial. Importantly, we reported promising interim results from the study showing that the addition of HS-110 to nivolumab may restore anti-tumor activity in patients whose disease has progressed after checkpoint inhibitor therapy. Our data showing tumor shrinkage in 35% of patients and disease control in 55% of patients whose disease has progressed after treatment with a checkpoint inhibitor (CPI) supports our mechanistic hypothesis that the broad, T-cell mediated immune response activated by HS-110 may reestablish positive clinical outcomes for patients who have lost the benefit of treatment with a CPI. We are encouraged by the positive results and look forward to reporting additional data later this year."

"Earlier this week, we announced that the FDA has cleared our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care. Up to 30 patients are expected to be enrolled in the trial. HS-130 is the first allogeneic, "off-the-shelf" cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, with the potential to augment antigen-specific CD8+ T cell response."

"We ended the quarter with approximately $19.5 million of cash, cash equivalents and short-term investments. These funds combined with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that we expect to receive after filing our IND for PTX-35 should provide us sufficient capital to fund Heat through our HS-110 data release, as well as other clinical programs."

Second Quarter 2019 Financial Results

Recognized $0.3 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses decreased approximately 2% to $3.4 million for the quarter ended June 30, 2019 compared to $3.5 million for the quarter ended June 30, 2018. The decrease of approximately $56,000 is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by the increased enrollment in the Phase 2 portion of our multi-arm NSCLC clinical trial and stock-based compensation.
General and administrative expense increased approximately 37% to $1.9 million for the quarter ended June 30, 2019 compared to $1.4 million for the quarter ended June 30, 2018. The $0.5 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
Net loss attributable to Heat Biologics was approximately $4.8 million, or ($0.14) per basic and diluted share for the quarter ended June 30, 2019 compared to a net loss of approximately $3.8 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2018.
As of June 30, 2019, the Company had approximately $19.5 million in cash, cash equivalents and short investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing our IND for PTX-35.
About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot" and be administered in combination with checkpoint therapies and other immuno-modulators to

On August 14, 2019 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the three and six months ended June 30, 2019 and provided an update on its development programs for ThermoDox and GEN-1 (Press release, Celsion, AUG 14, 2019, View Source [SID1234538760]). The Company’s lead program is ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin currently in Phase III development (the OPTIMA Study) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 is currently in Phase I/II development (the OVATION 2 Study) for the localized treatment of newly diagnosed Stage III/IV ovarian cancer.

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!

"With a clear focus on shareholder value, Celsion continues to execute its business plan for our ongoing clinical development programs with ThermoDox and GEN-1. We are exceptionally well positioned on the fundamentals with a strong balance sheet that is expected to fund our clinical programs through transformative milestones over the next 18 months," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We look forward to the first of two preplanned interim efficacy analyses for the OPTIMA Study expected in October 2019. At the current event rate, the second interim analysis, if needed, is expected to occur in early 2020. This global, pivotal study completed patient enrollment in August 2018 at more than 65 clinical sites in 14 countries, including all the major markets for primary liver cancer."

"The first cohort of patients in the dose-escalation portion of our OVATION 2 Study in newly diagnosed ovarian cancer has been enrolled. We continue to work through the activation of up to 30 clinical sites in the U.S. and Canada by the end of this year. Importantly, enrollment of patients in the Phase I portion of the study is expected to be completed and initial data reported by the end of 2019. This promising clinical development program in immunotherapy has generated impressive results in previous trials," Mr. Tardugno added.

Recent Developments

ThermoDox

Results of the National Institutes of Health Analysis of ThermoDox Published in the Journal of Vascular and Interventional Radiology. On August 13, 2019, the Company announced that results from an independent analysis of the Company’s ThermoDox HEAT Study conducted by the National Institutes of Health (NIH) were published in the peer-reviewed publication, Journal of Vascular and Interventional Radiology. The analysis was conducted by the intramural research program of the NIH and the NIH Center for Interventional Oncology (CIO), with the full data set from the Company’s HEAT Study. The analysis evaluated the full data set to determine if there was a correlation between baseline tumor volume and radiofrequency ablation (RFA) heating time (minutes/tumor volume in milliliters), with or without ThermoDox treatment, for patients with HCC. The NIH analysis was conducted under the direction of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology.

The article titled, "RFA Duration Per Tumor Volume May Correlate With Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated With RFA Plus Lyso-thermosensitive Liposomal Doxorubicin," discussed the NIH analysis of results from 437 patients in the HEAT Study (all patients with a single lesion representing 62.4% of the study population). The key finding was that increased RFA heating time per tumor volume significantly improved overall survival (OS) in patients with single-lesion HCC who were treated with RFA plus ThermoDox, compared to patients treated with RFA alone. A one-unit increase in RFA duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox, compared to RFA alone. The authors conclude that increasing RFA heating time in combination with ThermoDox significantly improves OS and establishes an improvement of over two years versus the control arm when the heating time per milliliter of tumor is greater than 2.5 minutes. This finding is consistent with the Company’s own results, which defined the optimized RFA procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lends support to the hypothesis underpinning the OPTIMA Study.

Data Lock for First Prespecified Interim Analysis in OPTIMA Phase III Study of ThermoDox in Primary Liver Cancer. On August 5, 2019, the Company announced the prescribed number of events has been reached for the first prespecified interim analysis of the OPTIMA Phase III Study with ThermoDox plus radiofrequency ablation (RFA) in patients with HCC. Following preparation of the data, the first interim analysis will be conducted by the Independent Data Monitoring Committee (iDMC). The iDMC meeting is expected to occur by mid-October. This timeline is consistent with the Company’s stated expectations and is necessary to provide a full and comprehensive data set that may represent the potential for a successful trial outcome. The iDMC recommendations will be announced as soon as possible after the meeting.

In accordance with the statistical plan, this initial interim analysis has a target of at least 118 events, or 60% of the total number required for the final analysis. At the time of the data cutoff, the Company received reports of 128 events. The hazard ratio for success at 128 events is approximately 0.63, which represents a 37% reduction in the risk of death compared with RFA alone, and is consistent with the 0.65 hazard ratio that was observed in the prospective HEAT Study subgroup, which demonstrated a two-year overall survival advantage and a median time to death of more than seven and a half years.

The OPTIMA Study was fully enrolled in August 2018 with 556 subjects from 65 clinical sites in 14 countries. The design of the OPTIMA Study is based on the Company’s HEAT Study, in which a subgroup analysis of 285 subjects with a single lesion of 3-7 cm in size received a single ThermoDox administration in combination with a 45-minute or longer RFA procedure. Followed prospectively for over 2.5 years, patients treated with ThermoDox demonstrated a median survival of more than 7.5 years and a survival benefit of more than two years over the control group. These data were published in the October 2017 issue of the peer-reviewed journal Clinical Cancer Research, and are available here.

IRB Approval to Begin a Clinical Study of ThermoDox Plus High Intensity Focused Ultrasound in Breast Cancer Patients at University Medical Center Utrecht in the Netherlands. On June 20, 2019, the Company announced that the University Medical Center Utrecht in the Netherlands received Institutional Review Board (IRB) approval to begin a Phase I study to determine the safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer (mBC). The secondary objective of this study is to assess radiological objective response of distant metastases and of the primary breast tumor.

This single-site, investigator-sponsored study – image-guided targeted doxorubicin delivery with hyperthermia to optimize loco-regional control in breast cancer; the i-GO Feasibility Study – will enroll up to 12 newly diagnosed mBC patients. Study subjects will receive up to six cycles of the following regimen at three-week intervals:

●60 minutes of MR-HIFU hyperthermia at 40oC to 42oC delivered to the primary tumor;
●50 mg/m2 of ThermoDox as a 30-minute intravenous (IV) infusion during hyperthermia; and
●600 mg/m2 of cyclophosphamide as a 15-minute IV infusion after hyperthermia.

This study further reinforces the broad potential of ThermoDox to treat a range of solid tumors with multiple localized heating sources.

Issuance of New U.S. Patent for ThermoDox. On April 17, 2019, the Company announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,251,901 B2 – Thermosensitive Nanoparticle Formulations and Method of Making the Same – which is directly applicable to the method of treating cancer using a new ThermoDox formulation. The claim covers a method for preparing (as well as the composition of) a doxorubicin sulfate temperature-sensitive liposome and extends protection for the ThermoDox patent portfolio to 2033. This new patent broadens the ThermoDox intellectual property portfolio and provides for lifecycle management well into the future.

Corporate Development

Celsion Participated in Two Investor Conferences. During May 2019, the Company attended the ThinkEquity Conference in New York City and the Deutsche Bank 44th Annual Health Care Conference in Boston. A webcast of Celsion’s presentation at the ThinkEquity Conference may be accessed by visiting the "News & Investors" section of Celsion’s corporate website. The format of the Deutsche Bank Health Care Conference was comprised of one-on-one and small group meetings with leading institutional investors.

Second Quarter Financial Results

For the quarter ended June 30, 2019, Celsion reported a net loss of $5.9 million ($0.29 per share), compared with $8.2 million ($0.46 per share) in the same period of 2018. Operating expenses were $5.7 million in the second quarter of 2019, which represented a $2.4 million (30%) decrease from $8.1 million in the same period of 2018. During the second quarter of 2019, the Company incurred $0.6 million in non-cash stock option expense, compared with $3.2 million in the comparable prior-year period.

Research and development expenses decreased $1.0 million to $3.6 million in the second quarter of 2019, compared with $4.6 million in the second quarter of 2018. Clinical development costs for the Phase III OPTIMA Study decreased $0.8 million to $1.2 million in the second quarter of 2019, compared with $2.0 million in the second quarter of 2018, due to the completion of enrollment in this 556-patient trial in August 2018. Costs associated with the startup of the OVATION 2 Study were $0.1 million in the second quarter of 2019. Other costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development programs increased by $0.3 million in the second quarter of 2019 compared with the prior-year period. In the second quarter of 2019, non-cash stock compensation expense decreased $2.6 million compared with the same period of 2018.

General and administrative expenses were $2.1 million in the second quarter of 2019, compared with $3.5 million in the same period of 2018. The decrease was primarily attributable to a $1.8 million decrease in non-cash stock compensation expense, offset by a $0.2 million increase in professional fees primarily related to recruiting fees for several new positions to support the anticipated regulatory and commercialization efforts for ThermoDox.

The Company realized $0.1 million of interest income from its short-term investments during the second quarters of 2019 and 2018. In connection with the Company’s venture debt facility with Horizon entered in late June 2018, the Company incurred interest expense of $0.3 million during the second quarter of 2019. This compares with interest expense of $15,000 in the comparable prior-year period.

The Company ended the second quarter of 2019 with $21.8 million in cash, investment securities and interest receivable. With $21.8 million in cash at June 30, 2019 coupled with future sales of the Company’s New Jersey NOL’s, the Company believes it has sufficient capital resources to fund its operations into the first quarter of 2021.

Six Month Financial Results

For the six months ended June 30, 2019, the Company reported a net loss of $8.3 million ($0.42 per share), compared with $12.7 million ($0.73 per share) in the same period of 2018. Operating expenses were $10.7 million during the first six months of 2019, which represented a $1.8 million (15%) decrease from $12.5 million in the same period of 2018. During the first half of 2019, the Company incurred $1.3 million in non-cash stock option expense, compared with $3.4 million in the comparable 2018 period.

Net cash used for operating activities was $10.7 million in the first six months of 2019, compared with $8.8 million in the same period in 2018. This was in line with the Company’s projected cash utilization for 2019 of approximately $18 million, or an average of approximately $4.5 million per quarter. Cash provided by financing activities was approximately $4.5 million during the first six months of 2019.

Research and development expenses decreased $1.0 million to $6.3 million in the first half of 2019 from $7.3 million in the first half of 2018. Clinical development costs for the Phase III OPTIMA Study decreased $1.2 million to $2.1 million in the first half of 2019, compared with $3.3 million in the first half of 2018, due to the completion of enrollment in this 556-patient trial in August 2018. Costs associated with the startup of the OVATION 2 Study were $0.2 million in the first half of 2019. Other costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development programs increased by $0.2 million in the first half of 2019 compared with the same prior-year period. In the first half of 2019, non-cash stock compensation expense decreased $2.1 million compared with the same period of 2018.

Other expenses in the first half of 2019 included a non-cash gain of $2.6 million, net of a $0.4 million charge for the issuance of 200,000 warrants related to an amendment for the potential milestone payments for the GEN-1 ovarian product candidate, compared with a non-cash charge of $0.5 million for the comparable prior-year period.

The Company realized $0.2 million of interest income during the first half of 2019 and 2018. In connection with the Company’s venture debt facility with Horizon entered in late June 2018, the Company incurred interest expense of $0.7 million during the first six months of 2019, compared with interest expense of $15,000 in the comparable prior-year period.

Conference Call

The Company is hosting a conference call to provide a business update and discuss its second quarter 2019 financial results at 11:00 a.m. EDT on Thursday, August 15, 2019. To participate in the call, dial 1-800-367-2403 (Toll-Free/North America) or 1-334-777-6978 (International/Toll) and use conference ID 2816618. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay until August 29, 2019 and can be accessed at 1-719-457-0820 or 1-888-203-1112 using conference ID 2816618. An audio replay will also be available for 90 days at www.celsion.com.

On August 14, 2019 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.27 billion for the third quarter ended July 31, 2019, up 6 percent year-over-year (and up 6 percent on a core basis(1)) (Press release, Agilent, AUG 14, 2019, https://www.agilent.com/about/newsroom/presrel/2019/14aug-gp19016.html [SID1234538758]).

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!

On a GAAP basis, third quarter net income was $191 million or $0.60 per share. This compares with $236 million or $0.73 per share in the third quarter of 2018. Non-GAAP net income(2) was $240 million or $0.76 per share during the quarter, compared with $217 million or $0.67 per share during the third quarter a year ago.

"The Agilent team delivered very strong results in the third quarter, exceeding both our top and bottom-line expectations," said Mike McMullen, Agilent president and CEO. "Building on this performance, we are increasing our guidance for the full year. In the quarter, we also announced the pending acquisition of BioTek, continuing our investments in high growth markets. BioTek will significantly expand our presence in the fast-growing field of cell analysis."

Financial Highlights

Life Sciences and Applied Markets Group

Third quarter revenue of $544 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) was up 1 percent year-over-year (and flat on a core basis(1)). Demand in the pharma, environmental and forensics markets was strong, offset by expected weakness in the food market. LSAG’s operating margin for the quarter was 21.7 percent.

Agilent CrossLab Group

Third quarter revenue of $467 million from the Agilent CrossLab Group (ACG) grew 10 percent year-over-year (up 11 percent on a core basis(1)). Growth was broad-based across all regions and market segments. ACG’s operating margin for the quarter was 26.2 percent.

Diagnostics and Genomics Group

Third quarter revenue of $263 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 11 percent year-over-year (up 13 percent on a core basis(1)). Growth in the company’s Nucleic Acid Solutions Division (NASD), and in the diagnostics and clinical markets drove the strong results. DGG’s operating margin for the quarter was 19.1 percent.

Full-Year and Fourth Quarter Outlook

For fiscal year 2019, the company is raising revenue guidance at the midpoint, to a range of $5.105 billion to $5.125 billion. Full-year non-GAAP earnings guidance is being increased to a range of $3.07 to $3.09 per share(3).

Agilent expects fourth quarter 2019 revenue in the range of $1.31 billion to $1.33 billion. Fourth quarter 2019 non-GAAP earnings are expected to be in the range of $0.84 to $0.86 per share(3).

Both the fiscal year and fourth quarter guidance excludes any impact of the pending BioTek acquisition. The acquisition is still expected to be completed in Agilent’s fiscal fourth quarter, subject to regulatory approvals and customary closing conditions.

Conference Call

Agilent’s management will present more details about its third quarter fiscal year 2019 financial results on a conference call with investors today at 1:30 p.m. (Pacific Time). This event will be webcast live in listen-only mode. Listeners may log on at www.investor.agilent.com and select "Q3 2019 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain available on the company’s website for 90 days.

The adjustment for taxes excludes tax benefits that management believes are not directly related to on-going operations and which are either isolated or cannot be expected to occur again with any regularity or predictability. For the three and nine months ended July 31, 2019, management used a non-GAAP effective tax rate of 16.67% and 16.75%, respectively. In the same periods last year, management used a non-GAAP effective tax rate of 18%.

We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, pension settlement gain, gain on step acquisition of Lasergen, NASD site costs, special compliance costs, adjustment for Tax Reform, and tax benefit on intra-entity asset transfer.

Business exit and divestiture costs include costs associated with business divestitures.

Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers including costs to move manufacturing due to new tariffs and tariff remediation actions, small site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system, human resources and financial systems.

Acquisition and Integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs.

Pension settlement gain resulted from transfer of the substitutional portion of our Japanese pension plan to the government.

Gain on step acquisition of Lasergen resulted from the measurement at fair value of our equity interest held at the date of business combination.

NASD site costs include all the costs related to the expansion of our manufacturing of nucleic acid active pharmaceutical ingredients incurred prior to the commencement of commercial manufacturing.

Special compliance costs include costs associated with transforming our processes to implement new regulations such as the EU’s General Data Protection Regulation (GDPR), revenue recognition and certain tax reporting requirements.

Other includes certain legal costs and settlements in addition to other miscellaneous adjustments.

Adjustment for Tax Reform primarily consists of an estimated provision of $480 million for U.S. transition tax and correlative items on deemed repatriated earnings of non-U.S. subsidiaries and an estimated provision of $53 million associated with the decrease in the U.S. corporate tax rate from 35% to 21% and its impact on our U.S. deferred tax assets and liabilities. The taxes payable associated with the transition tax, net of tax attributes, on deemed repatriation of foreign earnings is approximately $440 million, payable over 8 years.

Tax benefit on intra-entity asset transfer relates to our operations in Singapore along with our application of the new accounting rules for income tax consequences of intra-entity transfer of assets as adopted on November 1, 2018.

Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results "through the eyes" of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors.

Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

The preliminary non-GAAP net income and diluted EPS reconciliation is estimated based on our current information.

Income from operations reflect the results of our reportable segments under Agilent’s management reporting system which are not necessarily in conformity with GAAP financial measures. Income from operations of our reporting segments exclude, among other things, charges related to amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, gain on step acquisition of Lasergen, NASD site costs, and special compliance costs.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.

(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.

(b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.

The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.