Celsion Corporation (CLSN) Q4 2020 Earnings Conference Call March 19, 2021 11:00 AM ET Company Participants Kim Golodetz - Investor Relations Michael Tardugno - Chairman, CEO and President Jeff Church - Chief Financial Officer Khursheed Anwer - Chief Science Officer Nicholas Borys - Chief Medical Officer Operator Ladies and gentlemen, good morning. My name is David, and I will be your operator today. At this time, I would like to welcome you all to Celsion’s 2020 Financial Results Conference Call. All lines ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020. or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-15911 CELSION CORPORATION (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 FORM 10-K (State or ...

Celsion Corporation (CLSN) Q3 2020 Results Earnings Conference Call November 16, 2020 11:00 AM ET Company Participants Michael Tardugno - Chairman, President and CEO Jeff Church - Executive Vice President and CFO Dr. Nicholas Borys - Executive Vice President and CMO Kim Golodetz - LHA Investor Relations Conference Call Participants Hartaj Singh - Oppenheimer Raj Kumar - Brookline Capital Markets Operator Please standby. Good morning. My name is Casey, and I will be your operator today. At this time, I would ...

Product Pipeline and Clinical Studies - Celsion's product pipeline includes GEN-1 for ovarian cancer and ThermoDox, currently in Phase III for primary liver cancer[150] - The OPTIMA Study has enrolled 556 patients globally, evaluating ThermoDox in combination with RFA, with a primary endpoint of overall survival[156] - Post-hoc analysis from the HEAT Study indicated a 54% risk improvement in overall survival for patients treated with ThermoDox plus RFA compared to RFA alone[154] - The first interim analysis of the OPTIMA Study showed a hazard ratio of 0.63, indicating a 37% reduction in the risk of death compared to RFA alone[158] - The second interim analysis reached a hazard ratio of 0.70, representing a 30% reduction in the risk of death compared to RFA alone[164] - Median progression-free survival for the OPTIMA Study reached 17 months, which is favorable compared to 16 months in the HEAT Study subgroup[162] - The OPTIMA Study has lost only 4 patients to follow-up, significantly below the expected loss rate of 3% per year[162] - The DMC recommended the continuation of the OPTIMA Study based on safety and data integrity assessments[157] - The NIH published an analysis indicating that increased RFA heating time correlates with improved overall survival in patients treated with ThermoDox[160] - Celsion plans to continue following patients for overall survival, with a milestone of 197 deaths expected in mid-2021[166] - The HEAT Study did not meet the primary endpoint of progression-free survival (PFS) in a Phase III trial with 701 patients, indicating no clinically meaningful improvement[167] - In the OVATION Study, 14 patients treated with GEN-1 plus standard chemotherapy achieved a 100% disease control rate and an 86% objective response rate (ORR) as per RECIST criteria[171] - The median PFS for patients treated per protocol in the OVATION Study was 21 months, compared to an average of 12 months under the current standard of care for Stage III/IV ovarian cancer[173] - The OVATION 2 Study aims to show a 33% improvement in PFS by comparing GEN-1 with neoadjuvant plus adjuvant chemotherapy versus chemotherapy alone[176] - In the OVATION 2 Study, 64% of patients achieved complete tumor resection (R0) after treatment with GEN-1, with 88% in the highest dose cohorts[179] - The objective response rate (ORR) for patients receiving 0, 36, 47 mg/m² of GEN-1 plus NACT was approximately 80%, comparable to higher dose cohorts[181] - The European Medicines Agency recommended GEN-1 for orphan medicinal product designation for ovarian cancer treatment[182] - The independent Data Safety Monitoring Board (DSMB) approved the continuation of the OVATION 2 Study based on safety reviews of the first eight patients[177] Financial Performance and Capital Management - As of September 30, 2020, the company has incurred approximately $309 million in cumulative net losses and has $18.3 million in cash, investment securities, and interest receivable[189] - The company expects operating losses to continue for the foreseeable future due to ongoing product development and marketing efforts[190] - The company sold net operating losses totaling $13 million in 2018 and 2019, receiving net proceeds of $12.2 million[195] - The company has $10 million in capital from the Horizon Credit Agreement, with $5 million repaid and the remaining obligations restructured[196] - The company raised approximately $30.7 million in gross proceeds from issuing 17.8 million shares of common stock during 2019 and 2020[203] - The company received net proceeds of approximately $9.1 million from an underwritten offering of approximately 2.7 million shares at a price of $3.4875 per share[204] - The company has up to $24.5 million of remaining availability under the LPC Purchase Agreement with Lincoln Park Capital Fund, LLC[197] - The company returned the proceeds of a $632,220 PPP Loan in full on May 13, 2020, and later received a new PPP Loan for $692,530[200][201] - The company continues to monitor the impact of COVID-19 on its operations, with potential material impacts on future financial condition and results[192] - For the three months ended September 30, 2020, the company's net loss was $8.1 million, compared to a net loss of $5.5 million for the same period in 2019, representing a 47.3% increase in net loss[214] - For the nine months ended September 30, 2020, the company's net loss was $18.5 million, compared to a net loss of $13.7 million for the same period in 2019, indicating a 35.1% increase in net loss[214] - As of September 30, 2020, the company had $18.3 million in cash, investments, interest receivable, and income tax receivable, which is expected to fund operations through the end of 2021[215] - The company sold and issued an aggregate of 2.6 million shares under the LPC Purchase Agreement, receiving approximately $1.8 million in gross proceeds during 2020[206] - Under the 2018 Aspire Purchase Agreement, the company sold a total of 3.4 million shares, receiving $6.5 million before the agreement was terminated[205] - The 2019 Aspire Purchase Agreement allowed the company to sell up to $10.0 million of shares, with $0.7 million received from the sale of 0.5 million shares in 2019[205] - The company entered into a Capital on Demand Sales Agreement with JonesTrading, allowing for the sale of up to $16.0 million in shares, with $1.0 million and $4.5 million received in 2019 and 2020 respectively[205] - The LPC Purchase Agreement allows the company to sell up to $26.0 million of shares at its discretion, with a maximum purchase limit of 400,000 shares per business day[206] - The company issued 437,828 shares to Lincoln Park as LPC Commitment Shares, with an initial purchase of 1,000,000 shares for $1.00 per share[206] - The company plans to seek additional capital through public or private equity offerings, debt financing, and strategic alliances, which may dilute existing stockholder ownership[238] - If adequate funds are not available, the company may need to delay or reduce the scope of its research and development programs[239] - The company maintains a diversified investment portfolio to preserve capital and maximize income, with cash flow subject to interest rate fluctuations[241] Operating Expenses and Financial Metrics - Total operating expenses decreased by 22.3% to $4.3 million in Q3 2020 from $5.5 million in Q3 2019[216] - Loss from operations improved by 22.8%, amounting to $(4.2) million in Q3 2020 compared to $(5.4) million in Q3 2019[216] - Research and development expenses decreased by 32.2% to $2.5 million in Q3 2020 from $3.7 million in Q3 2019[218] - General and administrative expenses were stable at $1.8 million for both Q3 2020 and Q3 2019[219] - The company recognized a non-cash impairment charge of $2.4 million for the GBM asset in Q3 2020[220] - For the nine months ended September 30, 2020, total operating expenses decreased by 13.1% to $14.1 million from $16.2 million in the same period of 2019[226] - R&D expenses for the first nine months of 2020 decreased by 14.7% to $8.5 million compared to $10.0 million in the same period of 2019[227] - The company had an accumulated deficit of $309 million as of September 30, 2020[235] - The fair value of the earn-out milestone liability was assessed at $7.1 million as of September 30, 2020, with a non-cash charge of $1.1 million recognized in Q3 2020[223] - As of September 30, 2020, total current assets were $19.9 million, with cash and cash equivalents of $18.3 million, resulting in net working capital of $14.5 million[236] - Net cash used in operating activities for the first nine months of 2020 was $11.9 million, while net cash provided by investing activities was $7.9 million and financing activities provided $15.4 million[237] - The company received $1.3 million from two PPP Loans in 2020, which have been fully repaid as of September 30, 2020[237]

Celsion Corporation (CLSN) Q2 2020 Results Conference Call August 14, 2020 11:00 AM ET Company Participants Kim Golodetz - IR, LHA Investor Relations Michael Tardugno - Chairman, President and Chief Executive Officer Jeffrey Church - Senior Vice President and Chief Financial Officer Nicholas Borys - Chief Medical Officer Conference Call Participants Justin Kim - Oppenheimer Raj Kumar - Brookline Capital Markets Operator Good morning. My name is Cassidy and I will be your operator today. At this time, I w ...

PART I: FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements show increased cash and equity from financing activities, offset by continued net operating losses Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,653,760 | $6,875,273 | | Total current assets | $26,796,060 | $16,235,198 | | Total assets | $46,722,960 | $38,278,367 | | Total current liabilities | $9,205,745 | $7,894,457 | | Total liabilities | $22,514,798 | $23,719,332 | | Total stockholders' equity | $24,208,162 | $14,559,035 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Licensing revenue | $125,000 | $250,000 | | Research and development | $2,990,861 | $6,042,910 | | General and administrative | $1,901,136 | $3,740,042 | | Loss from operations | $(4,766,997) | $(9,532,952) | | Net loss | $(5,342,935) | $(10,399,813) | | Net loss per common share | $(0.18) | $(0.37) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited, Six Months Ended June 30) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash (used in) operating activities | $(7,923,276) | $(10,161,871) | | Net cash provided by (used in) investing activities | $5,147,269 | $(1,642,414) | | Net cash provided by financing activities | $18,554,494 | $4,464,060 | | **Increase (decrease) in cash and cash equivalents** | **$15,778,487** | **$(7,340,225)** | - The company is a development-stage oncology drug company focused on advancing a portfolio of innovative cancer treatments, including directed chemotherapies (ThermoDox®) and DNA-mediated immunotherapies (GEN-1)[43](index=43&type=chunk) - As of June 30, 2020, the company has incurred approximately **$301 million of cumulative net losses** and had approximately **$25.5 million in cash, investment securities, and interest receivable**, with management believing it has sufficient capital to fund operations through the end of 2021[47](index=47&type=chunk)[54](index=54&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical trial updates, including a futility recommendation for the ThermoDox® study, alongside financial results showing lower operating losses and sufficient capital through 2021 [Strategic and Clinical Overview](index=31&type=section&id=Strategic%20and%20Clinical%20Overview) The company's strategic focus is on advancing its lead oncology candidates, ThermoDox® and GEN-1, through clinical development towards commercialization - The company's lead product candidates are ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer[130](index=130&type=chunk) - In July 2020, the independent Data Monitoring Committee (DMC) recommended considering **stopping the global Phase III OPTIMA Study of ThermoDox®** for primary liver cancer after a futility analysis[143](index=143&type=chunk)[175](index=175&type=chunk) - The GEN-1 OVATION 2 study (Phase I/II) is evaluating GEN-1 plus standard chemotherapy in newly diagnosed Stage III/IV ovarian cancer, with initial Phase I data showing a **78% complete tumor resection (R0) rate** in the GEN-1 arm versus 50% in the chemotherapy-only arm[154](index=154&type=chunk)[160](index=160&type=chunk) - In March 2020, the European Medicines Agency (EMA) recommended **orphan medicinal product designation for GEN-1** for the treatment of ovarian cancer[158](index=158&type=chunk) [Business Plan and Financial Condition](index=40&type=section&id=Business%20Plan%20and%20Financial%20Condition) Despite a history of losses and COVID-19 risks, the company reports sufficient capital to fund operations through 2021 via recent financing activities - The company has incurred substantial operating losses since inception, with an **accumulated deficit of approximately $301 million** as of June 30, 2020[169](index=169&type=chunk) - With **$25.5 million in cash, investments, and receivables**, plus potential proceeds from selling New Jersey NOLs and an equity facility, management believes it has sufficient capital to fund operations through the end of 2021[178](index=178&type=chunk)[195](index=195&type=chunk) - The company raised approximately **$27.8 million in gross proceeds** from various equity transactions in 2019 and the first half of 2020, including an underwritten offering in June 2020 that yielded net proceeds of approximately $9.1 million[95](index=95&type=chunk)[185](index=185&type=chunk) - The **COVID-19 pandemic is identified as a risk** that could materially impact future financial condition, results of operations, and cash flows, potentially disrupting clinical trials and capital raising efforts[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Financial Review](index=46&type=section&id=FINANCIAL%20REVIEW%20FOR%20THE%20THREE%20AND%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202020%20AND%202019) Operating losses decreased for the three and six-month periods ended June 30, 2020, driven by lower R&D and G&A expenses Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $2,991 | $3,558 | (15.9)% | | General and administrative | $1,901 | $2,137 | (11.0)% | | **Loss from operations** | **$(4,767)** | **$(5,570)** | **14.4%** | | **Metric** | **Six Months Ended June 30, 2020** | **Six Months Ended June 30, 2019** | **Change (%)** | | Research and development | $6,043 | $6,325 | (4.5)% | | General and administrative | $3,740 | $4,355 | (14.1)% | | **Loss from operations** | **$(9,533)** | **$(10,430)** | **8.6%** | - **R&D expenses decreased by $0.6 million** in Q2 2020 compared to Q2 2019, primarily due to a decrease in costs for the OPTIMA Study from $1.2 million to $0.6 million[198](index=198&type=chunk) - **G&A expenses decreased** in Q2 2020 compared to Q2 2019, mainly due to lower professional fees[199](index=199&type=chunk) - The company recognized a **non-cash charge of $0.3 million** for the six months ended June 30, 2020, from the change in fair value of the earn-out milestone liability, compared to a non-cash benefit of $3.0 million in the same period of 2019[210](index=210&type=chunk)[211](index=211&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate changes affecting its investment portfolio, with no significant changes from the 2019 Form 10-K - The company's primary investment objective is to preserve capital while maximizing income without significantly increasing risk[220](index=220&type=chunk) - Cash flow and earnings are subject to fluctuations from changes in interest rates in the investment portfolio, which consists of various issuers, types, and maturities and is classified as available-for-sale[220](index=220&type=chunk) - The information required for this item is not significantly different from what was disclosed in the 2019 Form 10-K[221](index=221&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2020, with no material changes during the quarter - Management, including the CEO and CFO, concluded that as of June 30, 2020, the company's **disclosure controls and procedures are effective** at a reasonable assurance level[222](index=222&type=chunk) - **No changes in internal control** over financial reporting were identified during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[223](index=223&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) The company entered into a settlement agreement to resolve a 2019 shareholder lawsuit concerning the 2018 Stock Incentive Plan - A shareholder derivative and class action lawsuit was filed on September 20, 2019, alleging breaches of fiduciary duties concerning the approval of the 2018 Stock Incentive Plan[226](index=226&type=chunk) - On April 24, 2020, the parties entered into a Settlement Agreement to resolve the lawsuit, with terms including the repricing of certain stock options and a **payment of $187,500 for plaintiff's legal fees**[227](index=227&type=chunk) - A court hearing for final approval of the settlement was scheduled for September 8, 2020[227](index=227&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, clinical, regulatory, and operational risks, including the need for future capital and potential COVID-19 disruptions - **Financial Risk:** The company has a history of significant losses, with an **accumulated deficit of $301 million** as of June 30, 2020, and will need to raise additional capital to fund future operations[229](index=229&type=chunk)[234](index=234&type=chunk) - **Clinical Trial Risk:** Drug development is inherently uncertain, and the DMC recommended considering **stopping the Phase III OPTIMA study for ThermoDox® due to futility**, which highlights the high risk of failure at any stage[231](index=231&type=chunk)[232](index=232&type=chunk) - **Pandemic Risk:** The COVID-19 outbreak could adversely impact the business by disrupting preclinical studies, clinical trial enrollment, supply chains, and the ability to raise capital[245](index=245&type=chunk)[326](index=326&type=chunk) - **Regulatory Risk:** The company's novel gene-based products are subject to extensive and uncertain regulation by the FDA and other agencies, which could delay or prevent approval[250](index=250&type=chunk) - **Commercialization Risk:** The company **relies on third parties for clinical trials and manufacturing** and currently has no internal sales or marketing capabilities, which are critical for commercial success[277](index=277&type=chunk)[280](index=280&type=chunk)[316](index=316&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None[337](index=337&type=chunk) [Defaults Upon Senior Securities](index=67&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None[338](index=338&type=chunk) [Mine Safety Disclosures](index=67&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[338](index=338&type=chunk) [Other Information](index=67&type=section&id=Item%205.%20Other%20Information) No other information was required for disclosure during the period - None[339](index=339&type=chunk) [Exhibits](index=67&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including key agreements, plan amendments, and required officer certifications - Key exhibits filed include the **Underwriting Agreement with Oppenheimer & Co. Inc.** dated June 22, 2020, and the **Settlement Agreement** related to the O'Connor v. Braun et al. shareholder action[341](index=341&type=chunk) - The list also includes amendments to the 2018 Stock Incentive Plan, CEO and CFO certifications under Sarbanes-Oxley, and XBRL data files[341](index=341&type=chunk)

Celsion Corporation (CLSN) Q1 2020 Results Conference Call May 15, 2020 11:00 AM ET Company Participants Kim Golodetz - IR, LHA Investor Relations Michael Tardugno - Chairman, President and Chief Executive Officer Jeffrey Church - Senior Vice President and Chief Financial Officer Dr. Nicholas Borys - Chief Medical Officer Conference Call Participants Hartaj Singh - Oppenheimer Matthew Cross - JonesTrading Raj Kumar - Brookline Capital Markets Operator Good morning. My name is Cathy and I will be your operat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-15911 CELSION CORPORATION (Exact name of Registrant as specified in its charter) (State or other ...

Celsion Corporation (CLSN) Q4 2019 Results Earnings Conference Call March 26, 2020 11:00 AM ET Company Participants Kim Golodetz - IR, LHA Investor Relations Michael Tardugno - Chairman, President and Chief Executive Officer Jeffrey Church - Senior Vice President, Chief Financial Officer and Corporate Secretary Nicholas Borys - Senior Vice President and Chief Medical Officer Conference Call Participants Matthew Cross - Jones Trading Jason Kolbert - Dawson James Kumaraguru Raja - Brookline Capital Markets Op ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-15911 CELSION CORPORATION (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 (State or o ...