Celsion Corporation Reports 2020 Financial Results and Provides Business Update
Celsion Corporation (NASDAQ: CLSN) reported a 2020 net loss of $21.5 million ($0.67 per share), slightly worse than a $16.8 million loss in 2019. R&D expenses decreased by 15% to $11.3 million. The Phase I/II OVATION 2 Study with GEN-1 for ovarian cancer is over a third enrolled, showing promising interim results: 81% of GEN-1 patients achieved R0 resection, a 41% improvement over the control group. The company received FDA Fast Track designation for GEN-1 and filed a provisional patent for a DNA vaccine platform. Celsion has a strong balance sheet with a cash runway extending through 2023.
- Received FDA Fast Track designation for GEN-1 in advanced ovarian cancer.
- Phase I/II OVATION 2 Study shows 81% R0 resection rate for GEN-1 patients, a 41% improvement over control.
- Strong balance sheet with $17.2 million in cash and a $35 million offering securing funding through 2023.
- Net loss increased to $21.5 million in 2020 from $16.8 million in 2019.
- Decline in cash used for operating activities from $20.3 million in 2019 to $15.6 million in 2020 reflects ongoing losses.
Entered 2021 with a Focus on Cancer Immunotherapy and Next-Generation Infectious Vaccines and a Strong Balance Sheet
Conference Call Begins at 11:00 a.m. Eastern Time Today
LAWRENCEVILLE, N.J., March 19, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug development company focused on DNA-based immunotherapy and next-generation vaccines, today announced financial results for the year ended December 31, 2020 and provided an update on clinical development programs with GEN-1, a DNA-based immunotherapy in Phase I/II development for the localized treatment of ovarian cancer, and ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin under investigator-sponsored development for several cancer indications. In addition, Celsion has two feasibility-stage platform technologies for the development of novel nucleic acid-based immunotherapies and next-generation infectious vaccines.
“Celsion entered 2021 with a renewed focus and prioritization on DNA-based immunotherapies for ovarian cancer and an initiative for next-generation vaccines for preventing or treating infections from a broad range of infectious agents, including coronaviruses, using our PLACCINE DNA vaccine technology platform. All of our work is supported by a strong balance sheet and a three-year cash operating runway,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.
“Our Phase I/II OVATION 2 Study is over one-third enrolled. With 25 clinical sites to be activated by the end of the first quarter of 2021, encouraging trial data to date and the strong commitment of our clinical investigators, we expect to complete enrollment well before the end of 2021. Initial data at the 100 mg/m² dose cohort appear to be consistent with the directionally impressive results reported from our Phase Ib dose-escalating trial (the OVATION I Study) in ovarian cancer. Of 28 patients who completed interval debulking surgery,
Mr. Tardugno added, “During the first quarter of 2021, we announced an initiative to focus our considerable DNA plasmid experience and competencies on DNA vaccine development, an approach we believe may represent an advance in nucleic acid immunotherapy. Leveraging our clinical-stage TheraPlas platform, we envision a vaccine characterized by a single-plasmid DNA with multiple coding regions. Celsion’s plasmid vectors that are currently in development are designed to promote multiple antigens that are expressed by a single pathogen in combination with a potent immune modifier such as IL-12. IL-12 is the active ingredient currently used in our product candidate GEN-1. We are well positioned with a capital structure sufficient to support our planned R&D and clinical programs through transformative milestones. In doing so, we look to create significant value for our shareholders, patients and the medical community.”
Recent Developments
GEN-1 Immunotherapy
Announced Encouraging Interim Clinical Update on Phase I/II OVATION 2 Study with GEN-1 in Patients with Advanced Ovarian Cancer. On February 25, 2021, the Company provided an update on its Phase I/II OVATION 2 Study with GEN-1 in patients with advanced ovarian cancer. The OVATION 2 Study combines GEN-1 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, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. To date, the Company has enrolled approximately one-third of the anticipated 110 patients to be enrolled into the OVATION 2 Study. Currently, 28 patients have had their interval debulking surgery with the following results:
- 13 of 16, or
81% , of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed; - Seven of 12 patients, or
58% , of patients in the control arm had an R0 resection; and, - These interim data represent a
41% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been submitted for peer-review publication.
Received FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer. On March 22, 2021, the Company announced receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer. Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, a Fast-Track Drug must show some advantage over available therapy, including:
- Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
- Avoiding serious side effects of an available therapy
- Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment
Vaccine Initiative
Filed Provisional U.S. Patent Application for a Broad Range of Next-Generation DNA Vaccines. On January 28, 2021, the Company announced the filing of a provisional U.S. patent application for a novel DNA-based, investigational vaccine for preventing or treating infections from a broad range of infectious agents, including coronaviruses, using its PLACCINE DNA vaccine technology platform. The provisional patent covers a family of novel composition of multi-cistronic vectors and polymeric nanoparticles that comprise the PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the SARS-CoV-2 virus and its variants, using the Company’s platform technology. Celsion’s vaccine approach is designed to optimize the quality of the immune response dictating the efficiency of pathogen clearance and patient recovery. Celsion has taken a multivalent approach in an effort to generate an even more robust immune response that not only results in a strong neutralizing antibody response, but also a more robust and durable T-cell response. Delivered with Celsion’s synthetic polymeric system, the proprietary DNA plasmid is protected from degradation and its cellular uptake is facilitated.
PLACCINE is a natural extension of the Company’s synthetic, non-viral TheraPlas delivery technology currently in a Phase II trial for the treatment of late-stage ovarian cancer with GEN-1. Celsion's proprietary multifunctional DNA vaccine technology concept is built on the flexible PLACCINE technology platform that is amenable to rapidly responding to the SARS-CoV-2 virus, as well as possible future mutations of SARS-CoV-2, other future pandemics, emerging bioterrorism threats and novel infectious diseases. Celsion’s extensive experience with TheraPlas suggests that the PLACCINE-based nanoparticles are stable at storage temperatures of 4oC to 25oC, making vaccines developed on this platform easily suitable for broad worldwide distribution.
Formed a Vaccine Advisory Board. On February 12, 2021, the Company announced the formation of a Vaccine Advisory Board and the appointment of its first two members:
- Britt A. Glaunsinger, Ph.D., Professor, Virology & Molecular Biology, Howard Hughes Medical Institute, University of California, Berkeley; and
- Dr. Xinzhen Yang, M.D., Ph.D., Independent Professional Consultant for the Gerson Lehman Group and former Director of Viral Vaccines / Program Lead of the HCMV Vaccine Program at Pfizer Inc.
Corporate Developments
Strengthened Balance Sheet Through a
Received
Issued Letter to Stockholders with an Update on the Phase III OPTIMA Study with ThermoDox®. On February 11, 2021, the Company issued a letter to stockholders providing an update on the status of the Phase III OPTIMA Study and the decision to stop following patients in the Study. Since the surprising and incredibly disappointing second interim analysis results of the Phase III OPTIMA Study in primary liver cancer announced on July 9, 2020, in which the independent Data Monitoring Committee (DMC) found that the interim findings suggested futility, the Company continued to follow patients for overall survival (OS). Independent analyses conducted by a global biometrics contract research organization and by the National Institutes of Health (NIH) did not find any evidence of significance or factors that would justify continuing to follow patients for OS. Therefore, the Company has notified all clinical sites to discontinue following patients. The OPTIMA Study database of 556 patients was frozen at 185 patient deaths. While the analyses did identify certain patient subgroups that appear to have had a clinical benefit, the Company concluded that it would not be in its best interest to pursue these retrospective findings as the regulatory hurdles supporting further development will be significant.
Celsion will continue to work closely with and support investigations involving ThermoDox® by others throughout the world in breast cancer, pancreatic cancer and in solid tumors in children. Following inquiries from the NIH, the Company intends to renew its Cooperative Research and Development Agreement (CRADA) with the Institute at a nominal cost, one goal of which is to pursue the NIH’s interest in a study of ThermoDox® to treat patients with bladder cancer. Importantly, Celsion is developing a business model to support these investigator-sponsored studies in a manner that will not interfere with the Company’s focus on its GEN-1 programs and vaccine development initiative.
Financial Results for the Year Ended December 31, 2020
Celsion reported a net loss of
Research and development expenses were
General and administrative expenses were
Other expenses for 2020 included:
- a non-cash charge of
$1.3 million , compared with a non-cash gain of$2.8 million , net of a$0.4 million charge for the issuance of 200,000 warrants related to an amendment for the potential milestone payments for the GEN-1 ovarian cancer product candidate in 2019; - a non-cash charge of
$2.4 million related to the impairment of certain in-process research and development assets related to the development of the Company’s GBM cancer product candidate; - interest expense of
$1.3 million and$1.4 million in 2020 and 2019, respectively; and - interest income of
$0.1 million in 2020 and$0.5 million in 2019.
The Company recognized a
Net cash used for operating activities was
Conference Call
The Company is hosting a conference call at 11:00 a.m. EDT today to provide a business update and discuss 2020 financial results. To participate in the call, please dial 1-800-353-6461 (Toll-Free/North America) or 1-334-323-0501 (International/Toll) and ask for the Celsion Corporation fourth quarter 2020 Earnings Call (Conference Code: 1175518). The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Friday, March 19, 2021 and will remain available until April 2, 2021. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 1175518. An audio replay of the call will also be available on the Company's website, www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, March 19, 2021.
About Celsion Corporation
Celsion is a fully integrated, clinical stage biotechnology company focused on advancing a portfolio of innovative cancer treatments, including immunotherapies and DNA-based therapies; and a platform for the development of nucleic acid vaccines currently focused on SARS-CoV2. The company’s product pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, is under investigator-sponsored development for several cancer indications. Celsion also has two feasibility stage platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. Both are novel synthetic, non-viral vectors with demonstrated capability in nucleic acid cellular transfection. For more information on Celsion, visit www.celsion.com.
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. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, 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
609-482-2455
jchurch@celsion.com
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
Celsion Corporation
Condensed Statements of Operations
(in thousands except per share amounts)
| Year ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| Licensing revenue | $ | 500 | $ | 500 | ||||
| Operating expenses: | ||||||||
| Research and development | 11,345 | 13,065 | ||||||
| General and administrative | 7,641 | 8,000 | ||||||
| Total operating expenses | 18,986 | 21,065 | ||||||
| Loss from operations | (18,486 | ) | (20,565 | ) | ||||
| Other income (expense): | ||||||||
| (Loss) gain from valuation of earn-out milestone liability | (1,300 | ) | 3,190 | |||||
| Loss from impairment of in-process research and development | (2,370 | ) | - | |||||
| Fair value of warrants issued for milestone amendment | - | (400 | ) | |||||
| Interest expense, investment income and other income (expense), net | (1,173 | ) | (893 | ) | ||||
| Total other income (expense) | (4,843 | ) | 1,897 | |||||
| Net loss before income tax benefit | (23,329 | ) | (18,668 | ) | ||||
| Income tax benefit | 1,845 | 1,816 | ||||||
| Net loss | $ | (21,484 | ) | $ | (16,852 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.67 | ) | $ | (0.77 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 31,961 | 21,833 | ||||||
Celsion Corporation
Selected Balance Sheet Information
(in thousands)
| December 31, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 17,164 | $ | 6,875 | ||||
| Investment securities and interest receivable | - | 8,007 | ||||||
| Prepaid expenses and other current assets | 1,661 | 1,353 | ||||||
| Total current assets | 18,825 | 16,235 | ||||||
| Property and equipment | 295 | 405 | ||||||
| Other assets | ||||||||
| Deferred income tax asset | 1,846 | 1,820 | ||||||
| In-process research and development | 13,366 | 15,736 | ||||||
| Goodwill | 1,976 | 1,976 | ||||||
| Operating leases right-of-use | 1,047 | 1,432 | ||||||
| Other intangible assets, net | 114 | 341 | ||||||
| Other assets | 59 | 333 | ||||||
| Total other assets | 18,408 | 21,638 | ||||||
| Total assets | $ | 37,527 | $ | 38,278 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 4,703 | $ | 5,166 | ||||
| Deferred revenue – current portion | 500 | 500 | ||||||
| Operating lease liability – current portion | 433 | 388 | ||||||
| Notes payable - current portion | 1,117 | 1,840 | ||||||
| Total current liabilities | 6,753 | 7,894 | ||||||
| Earn-out milestone liability | 7,018 | 5,718 | ||||||
| Notes payable - noncurrent portion | 3,935 | 7,963 | ||||||
| Operating lease liability – noncurrent portion | 710 | 1,144 | ||||||
| Deferred revenue and other liabilities - noncurrent portion | 500 | 1,000 | ||||||
| Total liabilities | 18,916 | 23,719 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 407 | 232 | ||||||
| Additional paid-in capital | 330,290 | 304,886 | ||||||
| Accumulated other comprehensive gain (loss) | - | 43 | ||||||
| Accumulated deficit | (312,000 | ) | (290,517 | ) | ||||
| 18,696 | 14,644 | |||||||
| Less: Treasury stock | (85 | ) | (85 | ) | ||||
| Total stockholders' equity | 18,611 | 14,559 | ||||||
| Total liabilities and stockholders' equity | $ | 37,527 | $ | 38,278 | ||||
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FAQ
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