CLSN Celsion Corporation

3.68
0  0%
Previous Close 3.68
Open 3.77
52 Week Low 0.6865
52 Week High 6.5
Market Cap $122,247,318
Shares 33,219,380
Float 29,599,658
Enterprise Value $117,952,336
Volume 1,556,801
Av. Daily Volume 2,916,954
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Upcoming Catalysts

Drug Stage Catalyst Date
ThermoDox - OPTIMA
Hepatocellular carcinoma - liver cancer
Phase 3
Phase 3
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GEN-1 OVATION 2
Ovarian cancer
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GEN-1 OVATION 1
Ovarian cancer
Phase 1b
Phase 1b
Phase 1b PFS data released October 24, 2018 - PFS of 17.1 months in ITT population.
ThermoDox - Dignity
Recurrent Chest Wall Breast Cancer (RCWBC)
Phase 2
Phase 2
Final data released December 2015

Latest News

  1. LAWRENCEVILLE, N.J, June 25, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug-development company, today affirmed that the independent Data Monitoring Committee (iDMC) is scheduled to meet during the first half of July to conduct the second pre-planned interim safety and efficacy analysis of the Phase III OPTIMA Study with ThermoDox® plus RFA (radiofrequency ablation) in patients with hepatocellular carcinoma (HCC), or primary liver cancer. Members of the iDMC represent the global market for HCC and are based in the U.S., Canada and Europe, and Celsion believes that any logistical challenges to the Committee's performing its work presented by the global COVID-19 pandemic have been addressed. Celsion expects to announce…

    LAWRENCEVILLE, N.J, June 25, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug-development company, today affirmed that the independent Data Monitoring Committee (iDMC) is scheduled to meet during the first half of July to conduct the second pre-planned interim safety and efficacy analysis of the Phase III OPTIMA Study with ThermoDox® plus RFA (radiofrequency ablation) in patients with hepatocellular carcinoma (HCC), or primary liver cancer. Members of the iDMC represent the global market for HCC and are based in the U.S., Canada and Europe, and Celsion believes that any logistical challenges to the Committee's performing its work presented by the global COVID-19 pandemic have been addressed. Celsion expects to announce the iDMC's recommendations and Company next steps soon after the meeting concludes.

    Data lock for the second pre-specified interim analysis occurred during April 2020 after the prescribed minimum number of events of 158 patient deaths was reached.

    As previously announced, the hazard ratio for success at 158 deaths is 0.70, which represents a 30% reduction in the risk of death compared with RFA alone. The p-Value required is 0.022. Both compare favorably with the hazard ratio of 0.65 and p-Value = 0.02 observed in the prospective HEAT Study subgroup upon which the OPTIMA Study is based.

    Michael H. Tardugno, Celsion's chairman, president and chief executive officer, said, "The iDMC meeting is expected to take place as planned and we look forward to receiving their recommendation. While we are hopeful for a positive outcome, it is not a binary event for the OPTIMA Study. Should the data not reach the threshold for success, we believe the OPTIMA Study is ultimately well-positioned for success at the final analysis, if necessary. The final analysis would be based on 197 patient deaths where the hazard ratio for success is 0.75 or a 25% reduction in the risk of death, with a p-Value = 0.042. We believe that a successful study has blockbuster revenue potential and, more importantly, will be globally transformational for patients with HCC, the largest unmet need in oncology with more than 750,000 cases annually."

    About the OPTIMA Study

    The Phase III OPTIMA Study enrolled 556 patients at 65 clinical sites in North America, Europe, China and Asia Pacific. The Study is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3-7 cm in size, versus optimized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analyses of data from the Company's 701-patient HEAT Study, where optimized RFA demonstrated the potential to significantly improve survival when combined with ThermoDox®. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

    About ThermoDox®

    Celsion's most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD) whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.

    Celsion's LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream.

    In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.

    About Celsion Corporation

    Celsion is a fully integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in development for other cancer indications. The Company's product pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.

    Forward-looking Statements

    Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in the Celsion's periodic filings with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

    Celsion Investor Contact

    Jeffrey W. Church

    Executive Vice President and CFO

    609-482-2455

    Or

    LHA Investor Relations

    Kim Sutton Golodetz

    212-838-3777

    # # #

    Primary Logo

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  2. Lawrenceville, NJ, June 24, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the closing of its previously announced public offering of 2,666,667 shares of common stock, resulting in net proceeds of $9.3 million, after deducting underwriting discounts and commissions but before expenses payable by the Company.

    Oppenheimer & Co. Inc. acted as the sole underwriter for the offering.

    Celsion intends to use the net proceeds for clinical development of our product candidates, working capital and other general corporate purposes.
     
    This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236), previously filed with the Securities…

    Lawrenceville, NJ, June 24, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the closing of its previously announced public offering of 2,666,667 shares of common stock, resulting in net proceeds of $9.3 million, after deducting underwriting discounts and commissions but before expenses payable by the Company.

    Oppenheimer & Co. Inc. acted as the sole underwriter for the offering.

    Celsion intends to use the net proceeds for clinical development of our product candidates, working capital and other general corporate purposes.

     

    This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236), previously filed with the Securities and Exchange Commission (SEC) on September 7, 2018 and declared effective on October 12, 2018. The offering of the shares of common stock were made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering are filed with the SEC, and are available on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at  or by calling (212) 667-8055.

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

    About Celsion Corporation

    Celsion is a fully integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. Celsion's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com.

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements pertaining to Celsion's expectations regarding the expected use of proceeds described in this press release constitute forward-looking statements. All statements, other than statement of historical facts (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") are forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Celsion makes, including, but not limited to, uncertainties associated with market conditions and the completion of the public offering on the anticipated terms or at all and other risks described in the "Risk Factors" sections of Celsion's most recent annual report filed with the SEC on March 25, 2020, quarterly report filed with the SEC on May 15, 2020, the prospectus supplement related to the public offering and in other filings with the SEC. Celsion does not assume any obligation to update any forward-looking statements, except as required by law.

    Celsion Investor Contact

    Jeffrey W. Church

    Executive Vice President and CFO

    609-482-2455

    Or

    LHA Investor Relations

    Kim Sutton Golodetz

    212-838-3777

    # # #

    Primary Logo

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  3. Lawrenceville, NJ, June 22, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the entry into an underwriting agreement relating to the sale of 2,666,667 shares of its common stock at an offering price of $3.75 per share, less underwriting discounts and commission. The gross proceeds from the offering will be $10 million, before deducting underwriting discounts and commissions and estimated offering expenses. The shares of common stock are being sold to both existing and new institutional investors of the Company. The offering is expected to close on June 24, 2020, subject to satisfaction of customary closing conditions.

    Oppenheimer & Co. Inc. is acting as the sole underwriter…

    Lawrenceville, NJ, June 22, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced the entry into an underwriting agreement relating to the sale of 2,666,667 shares of its common stock at an offering price of $3.75 per share, less underwriting discounts and commission. The gross proceeds from the offering will be $10 million, before deducting underwriting discounts and commissions and estimated offering expenses. The shares of common stock are being sold to both existing and new institutional investors of the Company. The offering is expected to close on June 24, 2020, subject to satisfaction of customary closing conditions.

    Oppenheimer & Co. Inc. is acting as the sole underwriter for the offering.

    Celsion intends to use the net proceeds for clinical development of our product candidates, working capital and other general corporate purposes. 

    This shares are being offered by Celsion pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236), previously filed with the Securities and Exchange Commission (SEC) on September 7, 2018 and declared effective on October 12, 2018. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at  or by calling (212) 667-8055.

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

    About Celsion Corporation

    Celsion is a fully integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. Celsion's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. 

    This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements pertaining to Celsion's expectations regarding the intention to conduct an offering, and sale of securities, ability to complete the offering and expected use of proceeds described in this press release constitute forward-looking statements. All statements, other than statement of historical facts (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") are forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Celsion makes, including, but not limited to, uncertainties associated with market conditions and the completion of the public offering on the anticipated terms or at all and other risks described in the "Risk Factors" sections of Celsion's most recent annual report filed with the SEC on March 25, 2020, quarterly report filed with the SEC on May 15, 2020, the prospectus supplement related to the public offering and in other filings with the SEC. Celsion does not assume any obligation to update any forward-looking statements, except as required by law.

    Celsion Investor Contact

    Jeffrey W. Church

    609-482-2455

     

    LHA Investor Relations

    Kim Sutton Golodetz

    212-838-3777

     

    Primary Logo

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  4.  Excellent Surgical Response Noted at the Higher, 100 mg/m2 Dose

     Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable
    Risk/Benefit When Administered Over a Six-Month Period, Up to 17 Doses

    LAWRENCEVILLE, N.J., May 29, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced the final recommendations of the Data Safety Monitoring Board (DSMB) following completion of the Phase I dose-finding and tolerance portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer. Based on favorable safety data from 15 randomized patients, the DSMB has recommended that the Phase II portion of the OVATION Study proceed with the dose of 100

     Excellent Surgical Response Noted at the Higher, 100 mg/m2 Dose

     Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable
    Risk/Benefit When Administered Over a Six-Month Period, Up to 17 Doses

    LAWRENCEVILLE, N.J., May 29, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced the final recommendations of the Data Safety Monitoring Board (DSMB) following completion of the Phase I dose-finding and tolerance portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer. Based on favorable safety data from 15 randomized patients, the DSMB has recommended that the Phase II portion of the OVATION Study proceed with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose limiting toxicities were reported.

    The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery (IDS), followed by three additional cycles of chemotherapy in order to treat any remaining tumor after the surgery.

    The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT alone). GEN-1 is a formulation of Celsion's proprietary, synthetic, non-viral cell transfection platform TheraPlas, which incorporates DNA plasmids coded for the inflammatory protein interleukin-12 (IL-12). Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

    In March 2020, the Company announced the following clinical data from these first 15 patients enrolled in the OVATION 2 Study:

    • Of the 15 patients treated in the Phase I portion of the OVATION 2 Study:
      • Nine were treated with GEN-1 at a dose of 100 mg/m² plus NACT,
      • Six were treated with NACT only,
      • All 15 had successful resections of their tumors, with seven out of nine patients (78%) in the GEN-1 treatment arm having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and
      • Only three out of six patients (50%) in the NACT only treatment arm had an R0 resection.
    • When combining these results with the surgical resection rates observed in the Company's prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to the current standard of care NACT:
        % Patients with R0 Resections
    0, 36, 47 mg/m² of GEN-1 plus NACT n=12 42%
    61, 79, 100 mg/m² of GEN-1 plus NACT n=17 82%
    • The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were comparable, as expected, to the 61, 79, 100 mg/m² higher dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.

    The Company also engaged Medidata, a Dassault Systèmes company, to examine matched patient data provided by Medidata in a synthetic control arm (SCA) with results from the Company's completed Phase Ib dose-escalation OVATION 1 Study. The results were announced in March 2020, and showed positive data in PFS as follows:

    GEN-1 Population PFS Hazard Ratio (Confidence Interval)
    Intent-to-treat, n=15 0.53 (95% CI 0.16, 1.73); log-rank p=0.29
    Per-protocol, n=14 0.33 (95% CI 0.08, 1.37); log-rank p=0.11

    Patients in the GEN-1 arm virtually demonstrated a doubling of control of their cancer compared with the SCA. Findings are not statistically significant due to the small number of patients.

    "These findings show a consistent dose dependent clinical response in both surgical outcome and tumor response. This is further supported by a series of translational data of the tumor microenvironment," noted Dr. Nicholas Borys, Celsion's executive vice president and chief medical officer. "Continuing our clinical research program at the higher, 100mg/m2 dose, in this advance stage ovarian cancer population, holds promise and is strongly encouraged by our study investigators and medical advisors. We look forward to initiating enrollment as quickly as possible."

    "We are excited to be moving into the Phase II portion of the OVATION 2 Study, and thank the DSMB for their work and advice," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "The recommendation to proceed at the highest dose and the fact patients were able to tolerate 17 doses bode well for study success, particularly in light of the body of positive data we have generated for GEN-1 in the advanced ovarian cancer indication. With no good treatment options available, we are hopeful GEN-1 will make a meaningful difference in the lives of these women. As previously announced, we plan to begin the Phase II study in the fourth quarter of this year."

    In March 2020, the Company announced that GEN-1 has received Orphan Drug Designation from the European Medicines Agency. Celsion plans to consult with the U.S. Food and Drug to request Fast Track review and potential Breakthrough Therapy designation for GEN-1 based on this encouraging clinical data.

    About GEN-1 Immunotherapy

    GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is 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. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

    About Celsion Corporation

    Celsion is a fully integrated oncology company focused on developing a portfolio of innovative cancer treatments including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV)

    Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

    Celsion Investor Contact
    Jeffrey W. Church, EVP, CFO and Corporate Secretary
    609-482-2455
    LHA Investor Relations
    Kim Sutton Golodetz
    212-838-3777

    Primary Logo

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  5. Phase III OPTIMA Study on Track for Interim Data Analysis in July


    Conference Call Begins Today at 11:00 a.m. Eastern Time

    LAWRENCEVILLE, N.J, May 15, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the three months ended March 31, 2020, and provided an update on clinical development programs with ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, and GEN-1, its DNA-mediated IL-12 immunotherapy, currently in Phase I/II development for the treatment of advanced stage ovarian cancer.

    "During the first quarter and…

    Phase III OPTIMA Study on Track for Interim Data Analysis in July


    Conference Call Begins Today at 11:00 a.m. Eastern Time

    LAWRENCEVILLE, N.J, May 15, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced financial results for the three months ended March 31, 2020, and provided an update on clinical development programs with ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, and GEN-1, its DNA-mediated IL-12 immunotherapy, currently in Phase I/II development for the treatment of advanced stage ovarian cancer.

    "During the first quarter and recent weeks, Celsion continued to make substantial progress with our ongoing development programs with ThermoDox® and GEN-1, while maintaining a strong balance sheet," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "With our pivotal 556-patient Phase III OPTIMA Study in HCC fully enrolled, we now look forward to the preplanned interim efficacy analysis in July 2020."

    "Our GEN-1 immunotherapy product continued to show encouraging results at the 100 mg/m² dose cohort in the OVATION 2 Study, which is consistent with the results reported from our earlier Phase Ib trial (the OVATION 1 Study) in advanced stage ovarian cancer. These findings were reinforced by strong progression-free survival when comparing study patients to a statistically validated synthetic control arm of matched patients from prior studies. This unique means of evaluating efficacy holds great potential for clinical research, and we plan to use it in upcoming discussions with the U.S. Food and Drug Administration as part of our goal to accelerate GEN-1 clinical development. In addition, GEN-1 received Orphan Drug Designation from the European Medicines Agency in April 2020." Mr. Tardugno added, "Our fundamentals are strong, and we are well positioned with a capital structure sufficient to see our clinical programs through transformative milestones in 2020."

    Recent Developments

    ThermoDox®

    Sufficient Number of Patient Deaths Were Reached for the Second Interim Analysis of the Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer. In April 2020 the Company announced that the prescribed minimum number of events (158 patient deaths) was reached for the second pre-specified interim analysis of the OPTIMA Phase III Study with ThermoDox® plus RFA (radiofrequency ablation) in patients with HCC. Following preparation of the data, the Independent Data Monitoring Committee (iDMC) is expected to meet in July to conduct the second interim analysis. Celsion expects to announce iDMC recommendations as soon as possible after the meeting. The hazard ratio (HR) and p-value necessary for success at 158 deaths are 0.70 and 0.022, respectively, which compare favorably with the hazard ratio and p-value observed in the prospective HEAT Study subgroup upon which the OPTIMA Study is based.

    The OPTIMA Study was fully enrolled in August 2018 with 556 subjects from 65 clinical sites in 14 countries. The study design is based on the Company's HEAT Study, in which a prospective subgroup analysis of 285 subjects with a single lesion of 3-7 cm in size received a single ThermoDox® administration in combination with a 45 minute or longer RFA procedure. Followed prospectively for 3 years, those patients demonstrated a median survival of more than 7 ½ years and a survival benefit of more than 2 years over the control group. These data were published in the October 2017 issue of the peer-reviewed journal Clinical Cancer Research, and are available here.

    GEN-1 Immunotherapy

    GEN-1 Showed Strong Progression-Free Survival Treatment Effect Utilizing Medidata's Synthetic Control Arm. In March 2020 the Company announced that Medidata-matched patient data from a synthetic control arm (SCA) compared with results from the Company's completed Phase Ib dose-escalating OVATION 1 Study with GEN-1 in Stage III/IV ovarian cancer patients showed positive results in progression-free survival (PFS). The HR was 0.53 in the intent-to-treat group, showing strong signals of efficacy. Medidata is a globally recognized leader in clinical data management.

    Celsion believes these data may warrant consideration of strategies to accelerate the clinical development for GEN-1 in newly diagnosed, advanced ovarian cancer patients by the U.S. Food and Drug Administration (FDA). In its March 2019 discussion with Celsion, the FDA noted that preliminary findings from the Phase Ib OVATION 1 Study were exciting but lacked a control group to evaluate GEN-1's independent impact on impressive tumor response, surgical results and PFS. The FDA encouraged Celsion to continue its GEN-1 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and Breakthrough Therapy.

    GEN-1's strong and encouraging treatment effect, evidenced by the synthetic control arm, suggests a potentially remarkable improvement in PFS, an FDA-recognized surrogate for overall survival, and appears to confirm the science behind IL-12's ability to recruit the innate and adaptive elements of the immune system to fight malignancies. The strong PFS trend is supported by previously published translational data that clearly demonstrate the pro-immune changes in the tumor micro-environment associated with loco-regional GEN-1 therapy. Celsion's randomized Phase II OVATION 2 Study in advanced ovarian cancer patients is expected to commence in the fourth quarter of 2020 and is designed to demonstrate a 33% improvement in PFS (HR = 0.75) over current standard of care. PFS is the primary endpoint for this study.

    SCAs have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where a randomized control is not ethical or practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the patients treated with the new investigational product. SCAs have been shown to mimic the results of traditional randomized controls so that the treatment effects of an investigational product can be visible by comparison to the SCA. SCAs can help advance the scientific validity of single-arm trials, and in certain indications, reduce time and cost, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them. Medidata is in a unique position to create fit-for-purpose synthetic controls because of access to a pool of more than six million anonymized patients from nearly 20,000 previous clinical trials.

    PFS data generated from this analysis comparing GEN-1 with SCA showed the following:

    GEN-1 Population PFS Hazard Ratio (Confidence Interval)
    Intent-to-treat, n=15 0.53 (95% CI 0.16, 1.73); log-rank p=0.29
    Per-protocol, n=14 0.33 (95% CI 0.08, 1.37); log-rank p=0.11

    Highly Encouraging Initial Clinical Results from the Phase I Portion of the Phase I/II OVATION 2 Study with GEN-1 in Patients with Advanced Ovarian Cancer. In March 2020 the Company announced highly encouraging initial clinical data from the first 15 patients enrolled in the ongoing Phase I/II OVATION 2 Study for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT). Following NACT, patients undergo interval debulking surgery (IDS), followed by three additional cycles of chemotherapy.

    GEN-1 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below:

    • Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine were treated with GEN-1 at a dose of 100 mg/m² plus NACT and six were treated with NACT only. All 15 had successful resections of their tumors, with seven out of nine patients (78%) in the GEN-1 treatment arm having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had an R0 resection.
       
    • When combining these results with the surgical resection rates observed in the Company's prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to the current standard of care NACT:
        % of Patients with
        R0 Resections
         
    0, 36, 47 mg/m² of GEN-1 plus NACT n=12 42%
    61, 79, 100 mg/m² of GEN-1 plus NACT n=17 82%
    • The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0, 36, 47 mg/m² dose GEN-1 patients were comparable, as expected, to the higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both groups demonstrating an approximate 80% ORR.

    GEN-1 Received Orphan Drug Designation from the European Medicines Agency. In March 2020 the Company announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer. As established by the EMA, this designation provides for scientific advice and certain regulatory assistance during the product development phase, direct access to centralized marketing authorization and certain financial incentives for companies developing new therapies intended for the treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 people in the European Union (EU).

    Benefits of the designation include:

    • 10 years of market exclusivity (in which other industry sponsors are prevented from entering the market with a similar product for the same therapeutic indication);
    • EMA protocol assistance for sponsors on the conduct of the tests and trials necessary to demonstrate their quality, safety and efficacy, or regulatory assistance;
    • EMA advice will be free or given in return for reduced fees;
    • Access to a centralized procedure allowing immediate marketing authorization in all Member States and facilitating the availability of medicines to all patients in the EU;
    • Eligibility for a reduction of regulatory fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies.

    GEN-1 previously received orphan drug designation from the FDA.

    Corporate Developments

    Received $1.8 Million in Non-Dilutive Funding from the Sale of Its New Jersey State Net Operating Losses. In April 2020 the Company announced it received $1.82 million of net cash proceeds from the sale of approximately $1.9 million of its unused New Jersey net operating losses (NOLs). The NOL sales cover the tax years 2017 and 2018 and are administered through the New Jersey Economic Development Authority's (NJEDA) Technology Business Tax Certificate Transfer (NOL) Program. With this new non-dilutive funding, coupled with the $4.4 million in net proceeds from the recent registered direct equity offer completed on March 3, 2020, the Company strengthened its balance sheet at a time of capital markets uncertainty. An additional sale of $2.0 million of unused New Jersey NOLs anticipated in the second half of 2020 will further increase Celsion's cash reserves on a non-dilutive basis. In addition, the Company initiated several cost containment measures to ensure that it has sufficient cash to fund operations and clinical development programs through the second quarter of 2021, which includes all major Phase III OPTIMA Study readouts.

    On April 21, 2020, we entered into a loan agreement with Silicon Valley Bank (the "PPP Loan"), pursuant to the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act. We thereafter received proceeds of $632,220 under the PPP Loan. The PPP Loan application required Celsion to certify that there was economic uncertainty surrounding the Company and that, as such, the PPP Loan was necessary to support our ongoing operations. Celsion made this certification in good faith after analyzing, among other things, its financial situation and access to alternative forms of capital, and believes that the Company satisfied all eligibility criteria for the PPP Loan, and that our receipt of the PPP Loan proceeds was consistent with the broad objectives of the PPP of the CARES Act. The certification given with respect to the PPP Loan does not contain any objective criteria and is subject to interpretation. In light of subsequent guidance issued by the U.S. Small Business Administration in consultation with the U.S. Department of the Treasury, out of an abundance of caution, we returned the proceeds of the PPP Loan in full on May 13, 2020. Celsion may choose to reapply for the loan if the SBA provides future applicable guidance.

    Strengthened Balance Sheet Through a $4.8 Million Registered Direct Offering. In February 2020 the Company entered into securities purchase agreements with several institutional investors for the purchase and sale of 4,571,428 shares of the Company's common stock pursuant to a registered direct offering. Celsion also agreed to issue to such investors, in a concurrent private placement, warrants to purchase approximately 3.2 million shares of the Company's common stock. The warrants are exercisable on the six-month anniversary of the issuance date, will expire on the five-year anniversary of the initial exercise date and have an exercise price of $1.24 per share. Gross proceeds of the offering were $4.8 million before deducting placement agent fees and other estimated offering expenses.

    First Quarter Financial Results

    Celsion reported a net loss for the first quarter of 2020 of $5.1 million ($0.20 per share) compared with a net loss of $2.4 million ($0.12 per share) for the first quarter of 2019. Operating expenses were $4.9 million for the first quarter of 2020, which represented a $0.1 million (2%) decrease from $5.0 million in the same period of 2019. During the first quarter of 2020, the Company incurred $0.5 million in non-cash stock option expense compared with $0.7 million in the comparable prior-year period.

    Cash, cash equivalents, short-term investments, interest receivable and receivable on sale of deferred tax asset as of March 31, 2020 was $17.5 million. In the second quarter of 2020, the Company received $1.8 million in net proceeds from the sale of its New Jersey net operating losses. The Company has approximately $2.0 million in future tax benefits remaining under the NJEDA Technology Business Tax Certificate Transfer program for future years. Cash provided by financing activities was $5.8 million and net cash used for operating activities was $5.0 million for the first quarter of 2020, compared with $5.5 million for the comparable prior-year period.

    Research and development costs for the first quarter of 2020 were $3.1 million compared with $2.8 million for the first quarter of 2019. Clinical development costs for the Phase III OPTIMA Study were $0.7 million for the first quarter of 2020 compared with $0.9 million for the same period of 2019. These costs have decreased as the trial has moved into the follow-up phase after full patient enrollment in August 2018. Costs associated with the OVATION 2 Study increased to $0.3 million for the first quarter of 2020 compared with $0.1 million for the same period in 2019. The Company announced the initiation of the follow-on Phase I/II OVATION 2 Study in September 2018 with full enrollment of the Phase I portion of the trial completed in the first half of 2020. Costs associated with Celsion's wholly-owned subsidiary CLSN Laboratories, Inc. (which includes research and development activities for GEN-1, TheraPlas and TheraSilence) increased to $0.9 million in the first quarter of 2020 compared with $0.6 million in the first quarter of 2019 as the Company continued to expand its manufacturing capabilities and implemented programs to reduce manufacturing costs for GEN-1.

    General and administrative expenses were $1.8 million for the first quarter of 2020 compared with $2.2 million for the first quarter of 2019. The $0.4 million decrease was primarily attributable to a decrease in personnel costs and lower compensation expenses related to non-cash stock option compensation expense, partially offset by an increase in premiums for directors' and officers' insurance for 2020.

    Other expenses during the first quarter of 2020 included a non-cash charge of $41,000 for the change in valuation of the earn-out milestone liability for the GEN-1 ovarian product candidate compared with a non-cash gain of $2.7 million, net of charge of $0.4 million for the 200,000 warrant issuance related to an amendment for the potential milestone payments for the GEN-1 ovarian product candidate during the first quarter of 2019. The Company realized $0.1 million of interest income from its short-term investments during both the first quarter of 2020 and 2019. In connection with the Company's new venture debt facility with Horizon in June 2018, the Company incurred interest expense of $0.3 million during both the first quarter of 2020 and 2019.

    First Quarter Conference Call

    The Company will host a conference call to provide a business update and discuss its first quarter 2020 financial results at 11:00 a.m. EDT today. To participate in the call, interested parties may dial 1-800-367-2403 (Toll-Free/North America) or 1-334-777-6978 (International/Toll) 10 minutes before the call is scheduled to begin, and ask for the Celsion Corporation First Quarter 2020 Earnings Call (Conference Code: 6901311). The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay through May 29, 2020. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 6901311. 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, May 15, 2020.

    About Celsion Corporation

    Celsion is a fully integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com (CLSN-FIN).

    Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

    Celsion Investor Contact

    Jeffrey W. Church
    609-482-2455

    LHA Investor Relations
    Kim Sutton Golodetz
    212-838-3777



    Celsion Corporation
    Condensed Statements of Operations
    (in thousands except per share amounts)
    (unaudited)


        Three Months
    Ended
    March 31,
     
        2020     2019  
                 
    Licensing revenue   $ 125     $ 125  
                     
    Operating expenses:                
    Research and development     3,052       2,768  
    General and administrative     1,839       2,218  
    Total operating expenses     4,891       4,986  
    Loss from operations     (4,766 )     (4,861 )
                     
    Other (expense) income:                
    Gain (loss) from valuation of earn-out milestone liability     (41 )     3,130  
    Fair value of warrants issued in connection with amendment to modify earn-out milestone payments     -       (400 )
    Investment income, interest (expense) and other income (expense), net     (250 )     (236 )
     Total other income (expense), net     (291 )     2,494  
                     
    Net loss   $ (5,057 )   $ (2,367 )
                     
    Net loss per common share - basic and diluted   $ (0.20 )   $ (0.12 )
                     
    Weighted average common shares outstanding - basic and diluted     25,804       19,105  

    Celsion Corporation
    Selected Balance Sheet Information
    (in thousands)

        March 31, 2020
    (Unaudited)
        December 31,
    2019
     
    ASSETS                
    Current assets                
    Cash and cash equivalents   $ 5,746     $ 6,875  
    Investment securities and interest receivable on investment securities     9,910       8,007  
    Receivable on sale of deferred tax asset     1,820        
    Prepaid expenses and other current assets     1,401       1,353  
    Total current assets     18,877       16,235  
                     
     Property and equipment     375       405  
                     
    Other assets                
    Deferred tax asset     -–       1,820  
    In-process research and development     15,736       15,736  
    Goodwill     1,976       1,976  
    Operating lease right-of-use assets, net     1,339       1,432  
    Other intangible assets, deposits and other assets     634       674  
    Total other assets     19,685       21,638  
    Total assets   $ 38,937     $ 38,278  
                     
    LIABILITIES AND STOCKHOLDERS' EQUITY                
    Current liabilities                
    Accounts payable and accrued liabilities   $ 4,255     $ 5,166  
    Notes payable – current portion     2,276       1,840  
    Operating lease liability – current portion     399       388  
    Deferred revenue - current portion     500       500  
    Total current liabilities     7,430       7,894  
                     
    Earn-out milestone liability     5,759       5,718  
    Notes payable – noncurrent portion     7,624       7,963  
    Operating lease liability – non-current portion     1,040       1,144  
    Deferred revenue and other liabilities - noncurrent portion     875       1,000  
     Total liabilities     22,728       23,719  
    Stockholders' equity                
    Common stock     293       232  
    Additional paid-in capital     311,571       304,886  
    Accumulated other comprehensive gain (loss)     4       43  
    Accumulated deficit     (295,574 )     (290,517 )
          16,294       14,644  
    Less: Treasury stock     (85 )     (85 )
     Total stockholders' equity     16,209       14,559  
     

    Total liabilities and stockholders' equity
      $ 38,937     $ 38,278  

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