On May 14, 2018 ERYTECH Pharma (Euronext: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the quarter ended March 31, 2018 (Press release, ERYtech Pharma, MAY 14, 2018, View Source [SID1234526581]).

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"Following our successful Nasdaq listing at the end of last year, the first quarter of this year has been focused on the execution of the plan to advance our pipeline into solid tumor indications," said Gil Beyen, chief executive officer at ERYTECH. "Set up activities are on track for the launch of a pivotal Phase 3 trial in second line pancreatic cancer and a Phase 2 trial in first line triple-negative breast cancer. We are expanding our teams and increasing our manufacturing capacity in Europe and the U.S. Furthermore, we will meet with the FDA to discuss our ALL program and await the CHMP’s feedback on our MAA submission for relapsed and refractory ALL. We look forward to providing updates later this year."

Business Highlights

Feedback was obtained from the Commission for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) on the design of the proposed Phase 3 trial with eryaspase in second line pancreatic cancer, confirming earlier feedback by the U.S. Food and Drug Administration (FDA). The proposed Phase 3 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 500 patients in the United States and Europe. The primary endpoint will be overall survival (OS). An interim analysis is foreseen when approximately two-thirds of events have occurred. Set up activities for this pivotal Phase 3 clinical trial are ongoing. Enrollment of the first patient is expected in the third quarter of 2018.
Metastatic triple-negative breast cancer (TNBC) was selected as the next solid tumor indication for the development of eryaspase. TNBC is an aggressive and metabolically active form of breast cancer for which limited treatment options are available. The planned proof of concept Phase 2 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 60 previously untreated patients in Europe and the United States. An interim analysis is foreseen. The primary endpoint will be objective response rate. Set up activities are ongoing and start of patient enrollment is expected in the third quarter of 2018.
ERYTECH is planning to expand the clinical development of eryaspase to first-line pancreatic cancer, as well as to other solid tumor indications. Program updates are expected later in 2018 and early 2019.
Full results from the U.S. Phase 1 trial evaluating eryaspase in combination with chemotherapy for the treatment of first line adult ALL were presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The data showed eryaspase was well tolerated. Based on the pharmaco-kinetic data and the safety findings, the recommended dose for further clinical development was determined to be 100 U/kg. A meeting with the FDA to discuss the next steps in ALL in the United States is upcoming, based on which we expect to be able to provide feedback during the third quarter of 2018.
Additionally, the Company also presented pre-clinical data on the combination of eryaspase and erymethionase, methionine-gamma-lyase encapsulated in red blood cells. The data in this study suggested that this combination could be promising in vitro and in vivo in a gastric cancer model with tumor growth inhibition in-vivo and decreased tumor cell viability in vitro.
Earlier today, the Company announced the expansion of its executive management team with the addition of Alex Dusek as VP of Commercial Strategy, to lay the groundwork for commercial success and ensure commercial product preparedness, primarily in the U.S. He brings over 25 years of experience including commercial strategic roles at Argos Therapeutics, Bayer, and United Therapeutics.
Financial Highlights

Net loss for the three-month period ended March 31, 2018 was €11.7 million, compared to €6.5 million in the same period of 2017. The €5.2 million increase was primarily attributable to:
An increase in R&D expenses by €1.9 million, related to the Company’s intensified clinical and regulatory activities, as well as the additional staffing for preclinical research and clinical development.
An increase in G&A expenses by €0.8 million, resulting from continued infrastructure developments in line with the Company’s growth.
The accounting of a €2.5 million financial loss, as the Company’s cash position denominated in euros was impacted by the negative currency exchange variation in the period of the U.S. dollar against the euro.
As of March 31, 2018, ERYTECH had cash and cash equivalents totaling €171.8 million, compared with €185.5 million as of December 31, 2017. The €13.8 million decrease in total cash and cash equivalents in the three-month period comprised a total net cash utilization of €11.2 million for operating, investing and financing activities, and a €2.6 million negative foreign exchange impact on the Company’s cash position denominated in U.S. dollars. This financial accounting loss had no real cash impact, as the U.S. dollar position is kept in that currency for U.S. dollar disbursements.
Key Upcoming Milestones Expected in 2018

Meeting with the FDA to discuss next steps in ALL
Launch of a pivotal Phase 3 clinical trial in second-line pancreatic cancer in Europe and the United States
Launch of a Phase 2 proof-of-concept clinical trial in TNBC
CHMP opinion on MAA resubmission for GRASPA in R/R ALL
Initiation of a Phase 2 proof-of-concept clinical trial in first-line pancreatic cancer
Initiation of Phase 1 clinical trial with erymethionase
First Quarter Results 2018 Conference Call Details

As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, May 15th, 2018 at 02:30pm CET / 08:30am EDT to discuss business highlights and financial results for the first quarter of 2018. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3498017#

USA/Canada: +1 833 818 6807

United-Kingdom: +44 2031070289

Switzerland: +41 445802606

Germany: +49 6922224728

France: +33 176748988

Belgium: +32 24003547

Sweden: +46 856619361

Finland: +358 972519310

Netherlands: +31 207075547

Spain: +34 914142503

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 3498017#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

2018 Financial Calendar:

General Assembly Meeting of Shareholders: Friday, June 22, 2018 at 10:00am CET in Paris
Quarterly financial updates:
Business Update and Financial Highlights for the 2nd quarter and first-half of 2018: September 17, 2018 (after U.S. market close), followed by a conference call and webcast on September 18, 2018 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the 3rd quarter of 2018: November 12, 2018 (after U.S. market close), followed by a conference call and webcast on November 13, 2018 (2:30pm CET/8:30am ET)
Upcoming Investor Conferences:

BioEquity Europe 2018, May 16, Ghent
Gilbert Dupont Annual Healthcare Conference, May 29, Paris
Jefferies 2018 Global Healthcare Conference, June 5-6, New York
Journée Valeurs Moyennes SFAF, June 20, Paris
JMP Life Sciences Conference, June 20, New York
European Midcap Event – Spring, June 26-27, Paris

On May 14, 2018 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.21 billion for the second quarter ended April 30, 2018, up 9 percent year over year (up 4.3 percent on a core basis(1)) (Press release, Agilent, MAY 14, 2018, http://www.agilent.com/about/newsroom/presrel/2018/14may-gp18040.html [SID1234526808]).

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Second-quarter GAAP net income was $205 million, or $0.63 per share. Last year’s second-quarter GAAP net income was $164 million, or $0.50 per share.

During the second quarter, Agilent had intangible amortization of $25 million, business exit and divestitures of $8 million, transformational initiatives of $5 million, acquisition and integration costs of $4 million, and $11 million in other net gains. Excluding these items and a tax benefit of $24 million, Agilent reported second-quarter non-GAAP net income of $212 million, or $0.65 per share(2).

"Again this quarter, we delivered significant earnings and cash flow growth on strong top-line results, contributing to an excellent first half of 2018. We saw strength in the Pharma and Chemical & Energy markets with 8 percent and 5 percent growth this quarter, respectively," said Mike McMullen, Agilent CEO and president.

"We are successfully executing on our growth strategy," continued McMullen. "On the innovation front, we are seeing strong momentum in our newly released products and are continuing to introduce highly differentiated solutions to help our customers advance their work. We are also effectively deploying our capital—the recently closed acquisitions of Genohm and Lasergen, Inc. will add new strategic capabilities to drive future growth and create value for our customers and our shareholders."

Second-quarter revenue of $561 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) grew 7 percent year over year (up 3 percent on a core basis(1)). Strength in mass spectrometry and cell analysis led the results. LSAG’s operating margin for the quarter was 21.2 percent.

Second-quarter revenue of $426 million from the Agilent CrossLab Group (ACG) grew 13 percent year over year (up 7 percent on a core basis(1)). Growth was strong across services and consumables. ACG’s operating margin for the quarter was 23.1 percent.

Second-quarter revenue of $219 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 9 percent year over year (up 4 percent on a core basis(1)) led by strength in genomics. DGG’s operating margin for the quarter was 20.2 percent.

Agilent expects third-quarter 2018 revenue in the range of $1.185 billion to $1.205 billion. Third-quarter 2018 non-GAAP earnings are expected to be in the range of $0.61 to $0.63 per share(3).

For fiscal year 2018, revenue guidance of $4.850 billion to $4.870 billion is adjusted only for changes in currency. Core revenue growth of 5.5 percent at the midpoint of guidance remains unchanged. Agilent expects non-GAAP earnings of $2.63 to $2.67 per share(3). The guidance is based on April 30, 2018 currency exchange rates.

Conference Call

Agilent’s management will present more details about its second-quarter fiscal 2018 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 "Q2 2018 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.

Additional information regarding financial results can be found at www.investor.agilent.com by selecting "Financial Results" in the "Financial Information" section.

A telephone replay of the conference call will be available at approximately May 14, 2018 at 4:30 PM (Pacific Time) after the call and through May 21 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 7398497.

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 six months ended April 30, 2018, management uses a non-GAAP effective tax rate of 18.0%. In the same periods last year, management used a non-GAAP effective tax rate of 19.0%.
(b) GAAP diluted net loss per share was computed using 323 million weighted average diluted shares which excludes from consideration the anti-dilutive effects of all potential common shares outstanding.
(c) Non-GAAP diluted net income per share was computed using 326 million weighted average diluted shares which includes the dilutive effects of potential common shares outstanding.

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, transformational initiatives, acquisition and integration costs, pension settlement gain, NASD site costs, special compliance costs, and adjustment for Tax Reform.

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, 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.

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. The final impact of Tax Reform may differ materially from these estimates, due to, among other things, changes in interpretations, analysis and assumptions made, additional guidance that may be issued, and actions that we may undertake.

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.

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, 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.

On May 14, 2018 ABIVAX (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV as well as treatments for inflammatory/autoimmune diseases and cancer, reported the completion of enrollment of its Phase IIA clinical trial ABX464-101 in 30 patients with moderate-to-severe ulcerative colitis (Press release, ABIVAX, MAY 13, 2018, View Source [SID1234526552]).

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"ABIVAX is very pleased to announce the completion of enrolment in this first clinical trial exploring ABX464 for treatment of inflammatory indications," said Prof. Dr. Hartmut Ehrlich, M.D., chief executive officer at ABIVAX. "I would like to highlight the outstanding enthusiasm and dedication of Prof. Dr. Severine Vermeire, M.D., the Principal Investigator of this multinational trial and past president of ECCO (European Crohn’d and Colitis Organization), and thank the clinical trial sites, which kept recruitment on target, allowing us to report the top-line results from this important clinical trial in the autumn of this year," added Dr. Ehrlich.

ABX464-101 is a randomized, double-blind, placebo-controlled clinical trial (Phase 2a proof-ofconcept study) aimed at evaluating the safety and efficacy of ABX464 50 mg given once daily versus placebo for two months in subjects with moderate-to-severe active ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids. This clinical study is being conducted in 17 centers in seven European countries: Belgium, France, Germany, Austria, Hungary, Poland and Czech Republic. As of today, 30 out of the planned 30 patients have been randomized 2:1 to receive ABX464 or placebo, respectively. The study employs state-of-the art
technologies for monitoring potential treatment effects, including numerical recording of the colonoscopies with centralized reading.

ABX464-102 is a 12 months open label follow-up study for patients who completed ABX464-101, and 10 patients are already recruited into this clinical trial as of today. The rationale for the ABX464-101 study was derived from encouraging preclinical data, which demonstrated ABX464 had a strong anti-inflammatory effect. In macrophages, this effect was shown to be mediated by a 50-fold increase of the expression of IL-22, a cytokine known as a potent
suppressor of inflammatory processes, and a ten-fold increase of miR124 in peripheral blood mononuclear cells(PBMCs). mIR124 is a micro-RNA with potent anti-inflammatory properties and has recently been described as a tumor suppressor gene. Inflammation is a cornerstone of IBD, including ulcerative colitis and Crohn’s disease. When evaluated in a mouse model of IBD, ABX464 demonstrated a long-lasting effect in preventing the typical
symptoms of inflammatory colitis, including histological changes1
.
Prof. Dr. Severine Vermeire, M.D., Head of the IBD center at the University Hospitals Leuven, Belgium and Principal Investigator of the study, said: "reaching our recruitment goal of 30 patients marks an important step as there is a strong need to develop additional drugs in this indication; too many patients still do not respond or stop responding to current treatments. We are looking forward to the top-line data from this study and also to transferring as many patients as possible onto the one year open-label extension study with ABX464, which will provide us with very important long-term safety and efficacy data."

Ulcerative colitis is a debilitating inflammatory bowel disease in adults and children, with limited therapeutic management options for many patients. There is an estimated number of close to 1 million patients with ulcerative colitis in the United States, and global pharmaceutical sales for this disease are estimated to be around 5.7 billion US$ in 2017.

On May 11, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results and a business update for the first quarter ended March 31, 2018 (Press release, Adamis Pharmaceuticals, MAY 11, 2018, View Source [SID1234526537]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, "We have made a substantial amount of progress on several fronts since the beginning of the year. The development of our product pipeline continues to move forward and we have several target milestones that we hope to reach later this year. We believe the completion of these milestones will increase shareholder value. As for our progress on Symjepi , we continue to be pleased with developments regarding our discussions with potential commercialization partners. We believe that we are closer to concluding the process of naming our licensing partner and we remain focused on bringing this product to market."

Company Highlights and Product Updates

Some of the company’s product updates and accomplishments since the beginning of 2018 include the following:

Symjepi (epinephrine) Injection 0.15mg – The FDA determined that the company’s NDA for Symjepi (epinephrine) Injection 0.15mg was sufficiently complete to permit a substantive review and indicated that no potential review issues were identified as of the date of the agency’s communication in February. Approval is expected in the second half of this year.

Symjepi human factors data – Adamis presented human factors data for Symjepi at the American Academy of Allergy Asthma and Immunology joint congress with the World Allergy Organization, and another human factors study was published in the Annals of Allergy, Asthma and Immunology.

APC-1000 (Beclomethasone HFA) – Our product candidate received approval from the FDA to proceed with Phase 3 clinical studies. We continue to make progress in this area.

APC-6000 (Naloxone PFS) – We are working toward filing a New Drug Application (NDA) later this year and have completed pharmacokinetic (PK) studies.

Sales of several products sold by our U.S. Compounding, Inc. subsidiary have been increasing including Adamis’ unique compound to manage ulcers in horses. One horse that was receiving U.S. Compounding’s product recently came in first in the 2018 Kentucky Derby.

Second Quarter Financial Results

Revenues were approximately $3.2 million and $3.0 million for the three months ended March 31, 2018 and 2017, respectively. The increase in revenues (4.6%) for the three months ended March 31, 2018 compared to the comparable period of 2017 reflected an increase in the volume of sales of USC’s compounded pharmaceutical formulations resulting in part from increased sales and marketing personnel and efforts. The company’s revenues for the first quarter of 2018 increased approximately 11.9% compared to the revenues for the fourth quarter of 2017.

At March 31, 2018, the Company had cash and cash equivalents of $10.1 million. Net cash used in operating activities for the three months ended March 31, 2018 and 2017, was approximately $7.9 million and $3.5 million, respectively. Net cash used in operating activities increased primarily due to the increase in operating losses; increase in accounts receivable, inventories and prepaid expenses; and a decrease in accounts payable and accrued expenses as compared to 2017.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2018 and 2017 were approximately $6.5 million and $5.6 million, respectively. The increase in SG&A expenses was primarily due to new hires, compensation and stock option expenses, increases in accounting, audit and other professional fees, patent expenses, selling expenses and market research expenses related to Symjepi (epinephrine) and our APC-6000 product candidate.

Research and development expenses were approximately $2.2 million and $1.5 million for the three months ended March 31, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended March 31, 2018, compared to the comparable period of the prior year was due in part to an increase in development costs of our product candidates and compensation and stock option expenses, in part due to new hires.

Net loss for the first quarter of 2018 was approximately $7.6 million, compared to net loss of approximately $5.8 million for the same period in 2017.

Future Milestones

Some of the company’s goals for the 2018 year include the following:

Finalizing and announcing the commercialization strategy for Symjepi (epinephrine) Injection 0.3mg;

FDA approval for Symjepi TM (epinephrine) Injection 0.15mg;

Initiate pivotal Phase 3 studies of APC-1000 in asthmatics;

Complete a "proof of concept" study with dry powder inhaler platform using fluticasone;

Filing an NDA for Naloxone injection;

Increase sales of compounded medications from our U.S. Compounding, Inc. subsidiary by at least 30%.

On May 11, 2018 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 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, MAY 11, 2018, View Source [SID1234526538]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of ovarian cancer.

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"Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1. With sound fundamentals and a strong balance sheet, we are well positioned to complete enrollment in our ongoing 550 patient global, pivotal Phase III OPTIMA Study in primary liver cancer and to initiate our 130 patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer in June 2018 and reporting clinical findings from the Phase I cohort of 12 patients of the OVATION II by the end of 2018," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our GEN-1 immunotherapy has generated impressive results to-date. We expect to report final progression-free survival data from our Phase IB clinical trial (the OVATION I Study) by the end of the second quarter of 2018. These data will provide additional insights into GEN-1’s clinical and safety profile and reinforce our confidence in GEN-1’s potential to serve as a highly effective first-line therapy in newly diagnosed patients with ovarian cancer."

Recent Developments

ThermoDox

ThermoDox Highlighted at the International Liver Congress 2018 Symposium. On April 12, 2018, the Company announced a presentation and discussion of ThermoDox and the evolving treatment landscape for primary liver cancer or hepatocellular carcinoma (HCC), as part of a company-sponsored symposium at the International Liver Congress 2018, in Paris, France. The symposium titled, "Emerging Horizons in HCC: From Palliation to Cure," featured presentations by co-chairs and HCC experts, Ghassan Abou-Alfa, M.D., a board-certified medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, and Riccardo Lencioni, M.D., FSIR, EBIR, professor at the University of Pisa School of Medicine.

Dr. Abou-Alfa’s presentation, "New Developments in Targeted Therapies for HCC: The Mounting Wave of Immuno-Oncology," discussed recent developments in treating HCC, including the role of tyrosine kinase inhibitors (TKIs), immuno-oncology and CAR-T therapies, as well as advancements in chemotherapy and combination treatment with local therapy. Prof. Lencioni’s presentation, "Rethinking Our Approach to Intermediate-Size HCC" focused on the increasing incidence and burden of HCC globally, the limited overall survival benefit with current therapies at later stages of disease progression, and the potential for ThermoDox to provide enhanced survival benefit with standardized radiofrequency ablation. The slides from Prof. Lencioni’s presentation are available on Celsion’s corporate website at www.celsion.com.

Data Monitoring Committee Unanimously Recommended Continuation of the OPTIMA Study in Primary Liver after its Planned Safety and Data Review from 411 Patients; Enrollment Now at 85%. On April 9, 2018, the Company announced that the independent Data Monitoring Committee for the Company’s 550-patient, pivotal Phase III clinical study of ThermoDox in combination with radiofrequency ablation for primary liver cancer (the OPTIMA Study), unanimously recommended that the study continue according to protocol to its data readout. The DMC’s recommendation was based on the Committee’s assessment of safety and data integrity of the first 75% of patients randomized in the trial as of February 5, 2018 and concluded that the integrity of the study is intact and that ThermoDox is safe for continued enrollment of newly diagnosed, intermediate-stage patients. An analysis of blinded data from the intent-to-treat population, consolidated for both arms, indicated that median progression free survival (PFS) was 20.8 months. This compares favorably to the HEAT Study median PFS of 13.8 months and is consistent with the hypothesis-generating estimates from the HEAT Study manuscript published in the October 2017 issue of the peer-reviewed medical journal, ‘Clinical Cancer Research.’ 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.

The DMC analysis in April 2018 was the last planned interim analysis prior to enrollment completion in the third quarter of 2018 with results from the first interim efficacy analysis available in the first half of 2019.

Presentation of ThermoDox HEAT Study Manuscript by Lead Author, Dr. Won Young Tak, at Korean Liver Cancer Association’s 12th Annual Scientific Meeting. On Feb. 12, 2018, the Company announced that an abstract discussing the Company’s Phase III HEAT study evaluating ThermoDox in combination with radiofrequency ablation was one of six selected for presentation as part of the lecture of the Presidential Selection at the Korean Liver Cancer Association’s 12th Annual Scientific Meeting in Seoul, South Korea. Dr. Tak’s presentation highlighted learnings from the Company’s 701 patient HEAT Study and included results from simulation studies and findings from the post hoc subgroup analysis. Dr. Tak noted that key findings from the study and analyses of ThermoDox plus RFA suggested that the therapeutic effect of ThermoDox plus RFA may be improved when the RFA dwell time for solitary lesions is greater than or equal to 45 minutes.

Dr. Tak’s presentation explored the hypothesis prompted by these findings: ThermoDox, when used in combination with RFA standardized to a minimum dwell time of 45 minutes (sRFA ≥ 45 min), may increase the overall survival (OS) of patients with hepatocellular carcinoma. The final OS analysis from the HEAT Study demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox and standardized RFA provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) was 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox plus standardized RFA group translated into a 25.4-month (more than 2.1 years) survival benefit over the standardized RFA-only group – totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox plus standardized RFA group versus 53 months for the standardized RFA-only group.

GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program and Recent Clinical and Translation Research Data by Ovarian Cancer Expert at Oppenheimer & Co. Investor Event. On March 5, 2018, the Company announced that 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, and investigator in Celsion’s GEN-1 development program presented, "Ovarian Cancer: New Horizons and Treatments" at an investor event hosted by Oppenheimer & Co. in New York City on March 1, 2018.

Dr. Thaker’s presentation highlighted the following:

GEN-1 is a novel new approach that is 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.

In a Phase I study of GEN-1, 14 newly diagnosed patients with Stage III/IV ovarian cancer were intraperitoneally administered GEN-1 plus neoadjuvant chemotherapy. Results from the study demonstrated immunological changes consistent with the ability of GEN-1 to increase local (peritoneal) levels of IL-12 and its downstream anti-cancer cytokines and reduction in vascular endothelial growth factor (VEGF; potent angiogenic factor that contributes to tumor angiogenesis) levels with little change in systemic circulation.

The study showed no serious systemic toxicities. These clinical findings, including a partial or complete response in 86% of patients, R0 resections in 100% of patients treated at the highest dose cohort and recently reported progression-free survival (PFS) of over 21 months compared to historical controls for PFS of approximately 12 months, support further evaluation of GEN-1’s safety and efficacy in patients with Stage III/IV ovarian cancer.

Corporate Development

Corporate Presentations at Two Investor Conferences. In March 2018, the Company presented at two investor healthcare conferences:

The B. Riley FBR Inaugural China Healthcare Investing & Partnering Symposium. The conference was held March 15-17, 2018 at The InterContinental Hotel Hangzhou, China.

The Oppenheimer 28th Annual Healthcare Conference. The conference was held March 20-21, 2018 at The Westin New York Grand Central in New York City.

The webcast of Celsion’s presentation at the Oppenheimer conference has been archived on the "News & Investors" section of Celsion’s corporate website at www.celsion.com.

Raised $27.5 Million in Gross Proceeds During the Fourth Quarter of 2017, and an Additional $1.3 Million in Gross Proceeds During the First Quarter of 2018. Recent minimally dilutive equity offerings totaling approximately $28.8 million in gross proceeds during the fourth quarter of 2017 through January 2018 have strengthened the Company’s balance sheet and will be used to support the Company’s development efforts and potentially significant clinical milestones for ThermoDox and GEN-1 clinical programs into the third quarter of 2019.

The Company raised $17.0 million in gross proceeds through the exercise of outstanding common stock warrants in early October 2017.

In October 2017, the Company completed an underwritten equity offering of shares of common stock and warrants to purchase common stock with Oppenheimer & Co. The gross proceeds of the offering were approximately $6.6 million.

In November 2017 and January 2018, the Company raised $5.2 million in gross proceeds off its ATM Equity Facility with Cantor Fitzgerald.

Financial Results

For the quarter ended March 31, 2018, Celsion reported a net loss of $4.5 million, or a loss of $0.25 per share, compared to a net loss of $5.2 million, or a loss of $3.09 per share, in the same period of 2017.

Net cash used for operating activities was $4.7 million for the quarter ended March 31, 2018, compared to $3.1 million for the same period of 2017. Cash, cash equivalents, short-term investments and interest receivable at March 31, 2018 was $20.8 million. Cash provided by financing activities was approximately $1.2 million during the quarter ended March 31, 2018.

Research and development costs were $2.7 million for the quarter ended March 31, 2018, compared to $3.5 million for the same period of 2017. Clinical development costs for the Phase III OPTIMA Study were $1.3 million for the quarter ended March 31, 2018 compared to $1.6 million for the same period of 2017. R&D costs for other development programs were lower because of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer.

General and administrative expenses were $1.7 million for the quarter ended March 31, 2018, compared to $1.5 million for the same period of 2017. This modest increase was due to higher professional fees and an increase in non-cash stock option compensation expense.

As the Company paid off its Venture Debt Facility with Hercules Technology Growth Capital, Inc. during 2017, the Company did not have any interest expense in the first quarter of 2018. Interest expense was $0.1 million for the first quarter of 2017.

Quarterly Conference Call

The Company is hosting a conference call to provide a business update and discuss its first quarter 2018 financial results at 11:00 a.m. EDT on Friday May 11, 2018. To participate in the call, interested parties may dial 1-888-298-3457 (Toll-Free/North America) or 1-719-325-4917 (International/Toll) and ask for the Celsion Corporation First Quarter 2018 Earnings Call (Conference Code: 6550185) 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, May 11, 2018 and will remain available until Friday, May 25, 2018. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 (Toll-Free/USA) or 1-719-457-0820 (International/Toll) using Conference ID: 6550185. 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 on Friday, May 11, 2018.