Immunomic Therapeutics Presents Late-Breaking Preclinical Data on DNA Vaccine ITI-7000 at AACR 2019

On March 29, 2019 Immunomic Therapeutics, Inc. reported its late-breaking preclinical data which shows that its investigational nucleic acid platform, UNITE, may enhance antitumor immunity when used in connection with its investigational DNA vaccine, ITI-7000 (Press release, Immunomic Therapeutics, MAR 29, 2019, View Source [SID1234534890]). In preclinical studies, ITI-7000, an investigational DNA vaccine targeting ErbB2/HER2, demonstrated robust activation of known anti-tumor CD4 and CD8 cells in vivo and promoted tumor infiltration with activated CD8 T cells. These data are presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 meeting in Atlanta, Georgia.

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 addition to observing activation of known anti-tumor CD4 and CD8 cells in vivo, Immunomic scientists observed the overexpression of PDL1 in the tumor microenvironment. This pathway has shown clinical relevance as a cancer immunotherapy target of the tumor microenvironment. PDL1 overexpression upregulated by ITI-7000 suggests that a combination of ITI-7000 with an anti-PD1/PDL1 therapy may increase the therapeutic potential of either agent on its own. This data also supports the prevailing belief in the immunotherapy community that cancer vaccination could synergize with anti PD1 and PDL1 and other immunotherapies, as well as support the viability of the UNITE platform as a means to do so. In summary, these findings support the potential of ITI-7000 as a cancer vaccine and highlight that UNITE, Immunomic’s nucleic acid platform, may have the potential to enhance immunity of investigational cancer therapies.

View the poster.

Poster Title: DNA vaccine co-expressing Her2/ErbB2 antigen, fused with LAMP, elicits strong antitumor effects in vivo by increasing tumor infiltration with CD8+ T cells
Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 2
Session Date and Time: Tuesday, April 2, 2019 8:00 AM- 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 42

Aileron Therapeutics Announces Pricing of $26M Private Placement

On March 29, 2019 Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized cell-permeating peptides to treat cancer and other diseases, reported that it has entered into a securities purchase agreement with a group of institutional accredited investors for the private placement of $26 million of Aileron common stock and warrants (Press release, Aileron Therapeutics, MAR 29, 2019, View Source [SID1234534815]). The private placement is expected to close on or about April 2, 2019 subject to the satisfaction of customary closing conditions.

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!

The private placement was led by Satter Medical Technology Partners, L.P. with significant additional participation from Jennison Associates (on behalf of certain clients) and an undisclosed institutional investor, in addition to other new and existing investors.

The Company is selling in the private placement 11,838,582 units, consisting of 11,838,582 shares of common stock and associated warrants to purchase 11,838,582 shares of common stock, for a combined price of $2.01 per unit. In addition, the Company is also selling in the private placement 1,096,741 units, consisting of pre-funded warrants to purchase 1,096,741 shares of common stock and associated warrants to purchase 1,096,741 shares of common stock, for a combined price of $2.01 per unit.

William Blair & Company, L.L.C. will act as sole placement agent in connection with the financing.

Aileron expects to receive aggregate gross proceeds of approximately $26 million, before deducting placement agent fees and offering expenses, and excluding the exercise of any warrants. Aileron expects to use the net proceeds from the financing to fund the further advancement of its ALRN-6924 clinical trials and research programs, including its ongoing clinical trial collaboration with Pfizer testing ALRN-6924 in combination with palbociclib in MDM2-amplified cancers and its planned Phase 1b/2 clinical trial to evaluate ALRN-6924 as a myelopreservative agent, to protect against chemotherapy-induced toxicity. This use of proceeds reflects Aileron’s determination to cease enrollment and clinical development in AML/MDS in light of the Company’s resources and its assessment of the commercial opportunities, as well as the changed competitive landscape where seven drugs were approved for AML in the United States in the last two years.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Aileron has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of

common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement.

This release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Autolus Therapeutics Announces Conference Call to Discuss AUTO1 ALLCAR19 Data Presentation at the AACR Annual Meeting 2019

On March 29, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that management will host a conference call and webcast on Tuesday, April 2, 2019 at 8:00 am ET / 1:00 pm BST to discuss initial data on the AUTO1 ALLCAR19 Phase 1/2 trial in adult acute lymphoblastic leukemia (ALL) being presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 1, 2019 in Atlanta, Georgia (Press release, Autolus, MAR 29, 2019, View Source [SID1234534795]).

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!

Claire Roddie, MB PhD FRCPath, consultant hematologist, University College London Hospital and honorary senior lecturer, University College London, will deliver the poster presentation. Details include:

Abstract Number: CT105
Session Name: PO.CT04 – Phase I-III Trials in Progress: Part 1
TITLE: AUTO 1, a novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL
Session Date: Monday, April 1, 2019
Session Time: 1:00 PM – 5:00 PM ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17

The full text of the abstract is available on the AACR (Free AACR Whitepaper) website at View Source!/6812/presentation/9977.

Conference Call Information
Autolus management will host a conference call featuring Dr. Roddie on Tuesday, April 2, 2019 at 8:00 am ET/ 1:00 pm BST to discuss the ALLCAR19 data presented at AACR (Free AACR Whitepaper). To listen to the webcast and view the accompanying slide presentation, please go to View Source

The call may also be accessed by dialing 866-679-5407 (U.S.) or 409-217-8320 (international) and referencing conference ID 7679666. After the conference call, a replay will be available for one week. To access the replay, please dial 855-859-2056 (U.S.) or 404-537-3406 (international) and enter conference ID 7679666.

About AUTO1
AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety – while maintaining similar levels of efficacy – compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells’ abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights from UCL Business plc (UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 trials, one in pediatric ALL and one in adult ALL.
For information about the trials, visit View Source and
View Source

About Adult Acute Lymphoblastic Leukemia
According to the American Cancer Society, acute lymphoblastic leukemia (ALL) is predicted to affect approximately 5,960 adults in the United States in 2018. Combination chemotherapy enables 90% of adult patients to experience CR (complete response). Despite this, the prognosis of adult ALL is still poor and has not changed significantly during the last two to three decades, with long-term remission rates limited to 30–40%. Approximately 50% of all adult ALL patients will relapse.

Kymera Therapeutics to Present New Preclinical Data for its First-In-Class Oral IRAK4 Degrader in MYD88-Mutant Lymphoma at Late-Breaking Session of the American Association for Cancer Research Annual Meeting

On March 29, 2019 Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to create breakthrough medicines for patients, reported that it will present new preclinical data for its first-in-class oral IRAK4 protein degrader, KYM-001, in MYD88-mutant lymphoma (Press release, Kymera Therapeutics, MAR 29, 2019, View Source [SID1234534793]). Data will be presented in a late-breaking research session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 3 from 8 a.m. – 12 p.m. (Poster #18, Session: Experimental and Molecular Therapeutics 2). The study showed that KYM-001 led to highly selective degradation of IRAK4 and tumor regression upon oral dosing, both alone and in combination with BTK inhibition.

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!

"IRAK4 degraders offer an entirely new therapeutic approach to treat MYD88-driven B cell lymphomas, which are often aggressive and have a poor prognosis," said Nello Mainolfi, PhD, co-founder and Chief Scientific Officer, Kymera Therapeutics and study co-author. "IRAK4 kinase and scaffolding functions are critical to MYD88-driven Myddosome signaling. Unlike conventional kinase inhibitors, our novel degrader KYM-001 removes both the kinase and scaffolding function of IRAK4 to effectively block Myddosome signaling, resulting in tumor growth arrest and subsequent regression. The team has been able to very quickly identify orally active degraders that offer ease and flexibility of dosing. "

MYD88-activating mutations occur in 30-40% of patients with activated B cell-like (ABC) diffuse large B cell lymphoma (DLBCL). This study assessed the antitumor activity of Kymera’s orally active small molecule degraders in human ABC DLCBL cell lines in vitro and in tumor xenograft models in vivo, alone and in combination with the BTK inhibitor ibrutinib.

Study Highlights "KYM-001, a first-in-class oral IRAK4 protein degrader, induces tumor regression in xenograft models of MYD88-mutant ABC DLBCL alone and in combination with BTK inhibition":

KYM-001 induced potent and selective E3 ligase-dependent degradation of IRAK4 in multiple cellular models, resulting in 90% degradation at concentrations less than 100 nM.
KYM-001 induced comparable levels of IRAK4 degradation in both MYD88 mutant and MYD88 WT human ABC DLBCL cell lines.
KYM-001 impacted viability in MYD88 mutant, but not WT, ABC DLBCL cell lines, inducing apoptotic effects within 72 hours.
Oral dosing of KYM-001 showed dose-dependent antitumor activity against the MYD88 L265P mutant ABC DLBCL cell line OCI-LY10, with >80% degradation of IRAK4 correlating with tumor regression in xenograft-bearing mice.
KYM-001 was synergistic with the BTK inhibitor ibrutinib in vitro in ABC DLBCL cell lines bearing both MYD88 L265P and CD79 mutations. In vivo, this combined activity resulted in tumor regression at concentrations that were sub-optimal in single-agent studies, supporting further exploration of combinations that target oncogenic NFκB signaling.

Celsion Corporation Reports 2018 Financial Results

On March 29, 2019 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the year ended December 31, 2018 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAR 29, 2019, View Source [SID1234534784]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of 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!

"Celsion had an extraordinary 2018, making meaningful progress with our ongoing development programs for ThermoDox and GEN-1, as well as strengthening our balance sheet and cleaning up our capitalization structure. Among our many accomplishments, enrollment of our pivotal 556-patient global Phase III OPTIMA Study in HCC was completed ahead of projections, in August 2018. We are now looking forward to the first of two preplanned, interim efficacy analyses for the OPTIMA Study expected in the second half of 2019 and mid-2020, respectively. Our Phase I/II OVATION Study was initiated in the second quarter, as planned. This promising clinical development program in immunotherapy has generated impressive results. During the first quarter of 2019, we reported final data from our Phase 1B immunotherapy program (the OVATION I Study) in ovarian cancer. These data showed a significant improvement in progression-free survival in patients treated per protocol, 100% objective response rate (PR/CR) in patients treated at the two highest dose cohorts and 88% R0 surgical resection scores in patients treated at the two highest dose cohorts," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Entering 2019 with more than $27.7 million in cash and investments, we are well positioned with sound fundamentals, the right resources, and a sound capital structure sufficient to see our clinical programs through transformative milestones, and in doing so create significant value for our shareholders, patients and the medical community."

Recent Developments

ThermoDox

Data Monitoring Committee (DMC) Completed its Planned Safety and Data Review of Celsion’s Phase III OPTIMA Study. On December 18, 2018, the Company announced that the independent Data Monitoring Committee (DMC) for the Company’s pivotal Phase III OPTIMA Study unanimously recommended that the study continue according to protocol to its data readout. The DMC’s evaluation and recommendation were based on the Committee’s assessment of safety and data integrity for all 556 patients enrolled in the multinational, double-blind, placebo-controlled trial as of October 4, 2018.

This DMC review analyzed blinded data from the intent-to-treat population, consolidated for both arms, which showed that median PFS for the OPTIMA Study had reached 21.2 months as of October 4, 2018. These blinded, consolidated data continue to compare favorably to the HEAT Study median PFS of 13.8 months (all 701 patients) and 16.8 months (for the 285 patients in the subgroup of patients treated with RFA > 45 minutes) and remain consistent with our projections based on protocol enhancements informed by the HEAT Study results and the HEAT Study post-hoc analysis subgroup, the same patient population that the current Phase III pivotal study design was built on.

The DMC consists of an independent group of medical and scientific experts responsible for reviewing and evaluating patient safety and efficacy data for the Company’s Phase III OPTIMA Study. The DMC reviews study data at regular intervals in order to ensure the safety of all patients enrolled in the trial and to monitor the quality and overall conduct of the trial, including each site’s compliance with the study protocol. The OPTIMA Study’s design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.

Publication of ThermoDox Study Results in the Peer-Reviewed Journal, Radiology. On January 19, 2019, the Company announced that results from the Phase I TARDOX trial of ThermoDoxconducted at the University of Oxford, United Kingdom, were published in the peer-reviewed journal, Radiology. The findings published in Radiology serve as a companion paper to the groundbreaking work published in Lancet Oncology in July 2018. This was the first published study to evaluate ThermoDox when combined with high-intensity focused ultrasound (HIFU). The Radiology publication was accompanied by an editorial highlighting the significance of utilizing HIFU to safely deliver oncologically relevant volumes of doxorubicin with ThermoDox.

The article, titled, "Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial," included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox plus targeted, non-invasive ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling.

The Phase I TARDOX study was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust and evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial, 10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox, and ultrasonic heating of target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated without real-time thermometry. Safety was assessed by analysis of magnetic resonance imaging (MRI) and biopsy specimens for evidence of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects, including thermal ablation.

The Phase I TARDOX study demonstrated that focused ultrasound exposure with ThermoDox resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study.

GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. On March 4, 2019, the Company announced the oral presentation of data highlighting the safety, clinical response and translational data from the OVATION I Study by Premal H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium.

Dr. Thaker’s presentation highlighted the following:

●GEN-1 is a novel new approach designed to deploy the anti-cancer mechanism of the potent, broad-spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein.

●The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NAC) prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median PFS of 21 months in patients treated per protocol (n=14) and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, each of which compared favorably to the PFS historical average of 12 months for women with Stage III/IV ovarian cancer.

●Of the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses.

○Patients in the two higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. 100% of patients treated at the highest dose cohort had a complete R0 resection.

○Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 – an outcome not previously observed with NAC treatment alone.

●Pathological changes were assessed as part of the study, with the density of markers measured in tissue sections assessed via immunohistochemistry staining. Among patients administered the high doses of GEN-1 (n=8), pre-treatment to post-treatment reductions in key biomarkers were observed (FoxP3 -62.5%; IDO-1 -60%; PD-1 -62.5%; PD-L1 -37.5%). Reductions were also observed in patients administered the lower doses of GEN-1 (n=4) for all but one of the four key biomarkers (FoxP3 -40%; IDO-1 -40%; PD-1 +25%; PD-L1 -37.5%). The ratio of CD8+ cells to the four key immunosuppressive cell signals increased following treatment in 60 – 80% of patients.

●The study showed no serious systemic toxicities. Dose-limiting toxicity was not reached in the OVATION I Study. The most common adverse events attributed to GEN-1 in the OVATION I Study were nausea, abdominal pain/cramping, fatigue, vomiting, diarrhea and neutropenia.

Corporate Development

Celsion Signs Amendment to its June 6, 2014 Asset Purchase Agreement with EGEN, Inc. On March 28, 2019, the Company entered into an amendment to the June 6, 2014 Asset Purchase Agreement for the acquisition of substantially all of the assets of EGEN, Inc. The Amendment provides that payment of the $12.4 million earnout milestone liability under the Asset Purchase Agreement related to the Ovarian Cancer Indication can be made, at the Company’s sole discretion, in the following manner:

a)$7.0 million in cash to EGWU within 10 business days of achieving the milestone; or
b)$12.4 million to EGWU, which is payable in cash, common stock of the Company, or a combination of either, within one year after achieving the milestone.

Additionally, the Amendment extends the Earnout Term as it applies to the Ovarian Cancer Milestone from seven (7) years to eight (8) years from the original signing date of the Asset Purchase Agreement. As consideration for entering into the Amendment, the Company will issue to EGWU 200,000 warrants to purchase common stock with an exercise price of $0.01 per share. The Company will record this transaction in the first quarter of 2019.

Celsion Received $11.1 Million Allocation Through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program and State NOLs for the Tax Years 2011 to 2017 Approved. In December 2018, the Company announced it received approval from the New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) program to sell $11.1 million of its unused New Jersey NOLs for the tax years 2011 through 2017. The Company sold these New Jersey State NOLs to a qualified company with operations in New Jersey and received $10.4 million of net cash proceeds prior to the end of 2018.

Elimination of Warrant Overhang. In October 2018, the Company and certain investors holding warrants to collectively purchase 1.64 million shares of the Company’s common stock, which were granted in the February 2017 Public Offering and the October 2017 Underwritten Offering, entered into warrant exchange agreements whereby the Company issued 820,714 shares of its common stock in exchange for the termination of the warrants. The Company exchanged 0.5 share of common stock for each of 1.64 million warrants with exercise prices between $3.00 per share and $3.22 per share. Doing so, the Company eliminated the warrant overhang on its share price and the potential to use these warrants as a vehicle to hedge a short position. As of December 31, 2018, the Company has 18.8 million shares outstanding and 1.6 million warrants outstanding, of which 1.2 million of these outstanding warrants have an exercise price over $6.00 per share and will expire in early April 2019.

Financial Results

For the year ended December 31, 2018, Celsion reported a net loss attributable to common shareholders of $11.9 million ($0.68 per share) compared to a net loss of $20.7 million ($2.72 per share) for the year ended December 31, 2017. Operating expenses were $21.6 million for the year ended December 31, 2018, which represented a $2.6 million or 14% increase, from $19.0 million in the same period of 2017. During 2018, the Company incurred $4.6 million in non-cash stock option expense compared to $1.3 million in the comparable prior-year period.

Net cash used for operating activities was $7.0 million for the year ended December 31, 2018, compared to $16.6 million in the prior year. Cash and cash equivalents at December 31, 2018 were $27.7 million. Total cash provided by financing activities was approximately $11 million during 2018 which included $10 million in gross proceeds from the Company’s venture debt facility completed on June 27, 2018 with Horizon Technology Finance Corporation (Horizon) and $1 million in net proceeds from sales of common stock. In addition, the Company received $10.4 million in non-dilutive capital from the sale of its New Jersey state NOLs in the fourth quarter of 2018.

Research and development costs decreased by $1.2 million or 9%, from $13.1 million for the year ended December 31, 2017 to $11.9 million for the year ended December 31, 2018. Clinical development costs for the Phase III OPTIMA Study were $4.7 million for the year ended December 31, 2018 compared to $6.7 million for the same period of 2017. This $2.0 million decrease resulted from cost concessions negotiated with the lead contract research organization (CRO) for the OPTIMA Study as well as lower monthly CRO fees after completion of enrollment of this Phase III study during the third quarter of 2018. Costs associated with GEN-1 were $0.4 million for the year ended December 31, 2018, compared to $0.2 million in the comparable prior-year period. The Company announced the completion of enrollment of all cohorts of the OVATION I Study in 2017 and the initiation of the follow-on Phase I/II OVATION 2 Study during 2018. Costs associated with Celsion’s wholly-owned subsidiary, CLSN Laboratories, Inc. (which includes research and development activities for GEN-1, TheraPlas and TheraSilence) were $2.8 million in 2018 compared to $2.3 million in 2017 as the Company expanded its manufacturing capabilities and reduced the costs to manufacture GEN-1 for its planned clinical study requirements beyond 2018. In 2018, other clinical costs included an increase of $0.5 million in non-cash stock compensation expense compared to the same period of 2017.

General and administrative expenses were $9.7 million for the year ended December 31, 2018, compared to $5.9 million for the year ended December 31, 2017. This $3.8 million increase was due to higher professional fees of approximately $0.7 million, higher travel expenses of $0.1 million, and higher compensation expenses totaling $2.9 million in 2018 compared to 2017. Compensation expenses include costs associated with new personnel additions as well as an increase of $2.3 million related to non-cash stock option compensation expense in 2018 compared to the prior year.

Other expenses included a non-cash charge of $4.5 million for the year ended December 31, 2018, compared to a non-cash charge of $2.5 million for the year ended December 31, 2017, related to the impairment of certain in-process research and development assets related to the development of our glioblastoma multiforme (GBM) cancer product candidate offset by a $3.6 million reduction in the earn-out liability related to potential milestone payments for the GBM product candidate in 2018, and a corresponding $0.6 million reduction in the earn-out liability in 2017.

The Company realized $0.4 million of interest income from its short-term investments during 2018. Investment income was negligible in 2017. In connection with its new debt facility with Horizon, the Company incurred interest expense of $0.7 million during 2018 compared to $0.1 million during 2017. In the second quarter of 2017, Company paid off its prior loan facility with Hercules Technology Growth Capital, Inc.

During the fourth quarter of 2018, the Company recognized a $10.4 million income tax benefit resulting from the sale of its cumulative New Jersey NOLs. The Company has approximately $3.9 million in future tax benefits remaining under the NOL Program for future years

During 2017, the Company recognized deemed dividends totaling $0.4 million related to multiple agreements with certain warrant holders, pursuant to which these warrant holders agreed to exercise, and the Company agreed to reprice, certain warrants. Warrants to purchase 790,410 shares of common stock were repriced at $2.70 and warrants to purchase 506,627 shares of common stock were repriced at $1.65. The Company received $3.0 million in gross proceeds from the sale of these repriced warrants.

Year-End Conference Call

The Company is hosting a conference call to provide a business update and discuss year-end 2018 financial results at 11:00 a.m. EDT on Friday, March 29, 2019. To participate in the call, interested parties may dial 1-800-239-9838 (Toll-Free/North America) or 1-929-477-0448 (International/Toll) and ask for the Celsion Corporation Fourth Quarter and Year-End 2018 Earnings Call (Conference Code: 3754184) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on Friday, March 29, 2019 and will remain available until April 12, 2019. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 3754184. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, March 29, 2019.