As
filed with the Securities and Exchange Commission on November 8, 2019
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-1
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
CELSION
CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
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2834
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52-1256615
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(State
or other jurisdiction of
incorporation
or organization)
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(Primary
Standard Industrial
Classification Code Number)
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(I.R.S.
Employer
Identification
No.)
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997 Lenox Drive, Suite 100
Lawrenceville,
NJ 08648
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(Address, including zip code,
and telephone number, including area code of registrant’s principal executive offices)
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Michael
H. Tardugno
Chairman,
President and Chief Executive Officer
997
Lenox Drive, Suite 100
Lawrenceville,
NJ 08648
(609)
896-9100
(Name,
address and telephone number, including area code, of agent for service)
Copies
to:
Sam
Zucker, Esq.
Goodwin
Procter LLP
601
Marshall Street
Redwood
City, CA 94063
(650)
752-3100
Approximate
date of commencement of proposed sale to the public: As soon as practicable after the effective date of this
registration statement.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933 check the following box. [X]
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
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[ ]
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Accelerated
filer
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[ ]
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Non-accelerated
filer
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[ ]
(Do not check if a smaller reporting company)
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Smaller
reporting company
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[X]
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Emerging
growth company
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[ ]
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
[ ]
CALCULATION
OF REGISTRATION FEE
Title of securities to be registered
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Amount
to be
registered (1)
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Proposed
maximum
offering
price per
share
(2)
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Proposed
maximum
aggregate
offering
price (2)
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Amount
of registration
fee
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Common Stock, $0.01 par value
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4,500,000
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$
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1.43
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$
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6,435,000
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$
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836
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(1)
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Represents 4,500,000 shares of common stock that are issuable pursuant to a common stock purchase agreement with the selling stockholder named herein. Pursuant to Rule 416(a) of the Securities Act of 1933, as amended, this registration statement also covers any additional shares of common stock which may become issuable to prevent dilution from stock splits, stock dividends and similar events.
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(2)
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Estimated in accordance with Rules 457(c)
and (h) under the Securities Act solely for the purposes of calculating the registration fee. The price per share represents
the average high and low sales prices of the Common Stock as reported on the NASDAQ Capital Market on November 6, 2019.
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The
registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until
the registrant shall file a further amendment that specifically states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on
such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. The selling stockholder may not sell these securities until
the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to
sell these securities, and the selling stockholder is not soliciting offers to buy these securities, in any state where the offer
or sale of these securities is not permitted.
PROSPECTUS,
SUBJECT TO COMPLETION, DATED NOVEMBER 8, 2019
4,500,000
Shares
Common
Stock
This
prospectus relates to the sale of up to 4,500,000 shares of our common stock by Aspire Capital Fund, LLC. Aspire Capital is also
referred to in this prospectus as the selling stockholder. The prices at which the selling stockholder may sell the shares will
be determined by the prevailing market price for the shares or in negotiated transactions. We will not receive proceeds from the
sale of the shares by the selling stockholder. However, we may receive proceeds of up to $10.0 million from the sale of our common
stock to the selling stockholder, pursuant to a common stock purchase agreement entered into with the selling stockholder on October
28, 2019, once the registration statement, of which this prospectus is a part, is declared effective.
The
selling stockholder is an “underwriter” within the meaning of the Securities Act of 1933, as amended. We will pay
the expenses of registering these shares, but all selling and other expenses incurred by the selling stockholder will be paid
by the selling stockholder.
Our
common stock is listed on the Nasdaq Capital Market under the ticker symbol “CLSN.” On November 6, 2019, the
last reported sale price per share of our common stock was $1.43 per share.
You
should read this prospectus and any prospectus supplement, together with additional information described under the headings “Incorporation
of Certain Documents by Reference” and “Where You Can Find More Information,” carefully before you invest in
any of our securities.
Investing
in our securities involves a high degree of risk. See “Risk Factors” on page 8 of this prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 2019.
TABLE
OF CONTENTS
Neither
we nor the selling stockholder have authorized anyone to provide you with additional information or information different from
that contained in this prospectus filed with the Securities and Exchange Commission, or the SEC. We take no responsibility for,
and can provide no assurance as to the reliability of, any other information that others may give you. The selling stockholder
is offering to sell, and seeking offers to buy, our common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery
of this prospectus or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects
may have changed since that date.
Neither
we nor the selling stockholder have taken any action that would permit this offering or possession or distribution of this prospectus
in any jurisdiction where action for that purpose is required, other than in the United States. Persons who have come into possession
of this prospectus in a jurisdiction outside the United States are required to inform themselves about and to observe any restrictions
relating to the offering of the shares of common stock and the distribution of this prospectus.
This
prospectus incorporates by reference important information as further described under “Where You Can Find More Information”
and “Incorporation of Certain Information by Reference.” We may amend or supplement this prospectus from time to time
by filing amendments or supplements. You should read the entire prospectus and any amendments or supplements, together with any
documents that we incorporate by reference in this prospectus, before making an investment decision.
SUMMARY
This
summary highlights certain information about us, this offering and selected information contained in the prospectus. This summary
is not complete and does not contain all of the information that you should consider before deciding whether to invest in our
common stock. For a more complete understanding of our company and this offering, we encourage you to read and consider the more
detailed information in the prospectus, including “Risk Factors” and the financial statements and related notes. Unless
we specify otherwise, all references in this prospectus to “Celsion,” “we,” “our,”
“us” and “our company” refer to Celsion Corporation.
CELSION
CORPORATION
Company
Overview
We
are a fully integrated development clinical stage oncology drug company focused on advancing innovative cancer treatments, including
directed chemotherapies, DNA-mediated immunotherapy and RNA based therapies. Our lead product candidate is ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, currently in a Phase III clinical trial for the treatment of primary liver
cancer (the “OPTIMA Study”). Second in our pipeline is GEN-1, a DNA-mediated immunotherapy for the localized treatment
of ovarian cancer. These investigational products are based on technologies that provide the platform for the future development
of a range of therapeutics for difficult-to-treat forms of cancer. The first technology is Lysolipid Thermally Sensitive Liposomes,
a heat sensitive liposomal based dosage form that targets disease with known chemotherapeutics in the presence of mild heat. The
second technology is TheraPlas, a novel nucleic acid-based treatment for local transfection of therapeutic DNA plasmids. With
these technologies we are working to develop and commercialize more efficient, effective and targeted oncology therapies that
maximize efficacy while minimizing side effects common to cancer treatments.
ThermoDox®
ThermoDox®
is being evaluated in a Phase III clinical trial for primary liver cancer, which we call the OPTIMA Study, which was initiated
in 2014. ThermoDox® is a liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment
of a wide range of cancers. Localized heat at hyperthermia temperatures (greater than 40° Celsius) releases the encapsulated
doxorubicin from the liposome enabling high concentrations of doxorubicin to be deposited preferentially in and around the targeted
tumor.
The
OPTIMA Study. The OPTIMA Study represents an evaluation of ThermoDox® in combination with a first line therapy, RFA,
for newly diagnosed, intermediate stage HCC patients. HCC incidence globally is approximately 755,000 new cases per year and is
the third largest cancer indication globally. Approximately 30% of newly diagnosed patients can be addressed with RFA.
On
February 24, 2014, we announced that the United States Food and Drug Administration, or the FDA, provided clearance for the OPTIMA
Study, which is a pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox®, in combination with standardized
RFA, for the treatment of primary liver cancer. The trial design of the OPTIMA Study is based on the comprehensive analysis of
data from an earlier clinical trial called the HEAT Study. The OPTIMA Study is supported by a hypothesis developed from an overall
survival analysis of a large subgroup of patients from the HEAT Study.
The
OPTIMA Study was designed with extensive input from globally recognized HCC researchers and expert clinicians and after receiving
formal written feedback from the FDA. The OPTIMA Study was designed to enroll up to 550 patients globally at approximately 65
clinical sites in the U.S., Canada, European Union (EU), China and other countries in the Asia-Pacific region and will evaluate
ThermoDox® in combination with standardized RFA, which will require a minimum of 45 minutes across all investigators and clinical
sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for this clinical trial
is overall survival , or OS, and the secondary endpoints are progression free survival and safety. The statistical plan calls
for two interim efficacy analyses by an independent Data Monitoring Committee, or DMC.
Post-hoc
data analysis from our earlier Phase III HEAT Study suggest that ThermoDox® may substantially improve OS, when compared to
the control group, in patients if their lesions undergo a 45-minute RFA procedure standardized for a lesion greater than 3 cm
in diameter. Data from nine OS sweeps have been conducted since the top line progression free survival, or PFS, data from the
HEAT Study were announced in January 2013, with each data set demonstrating substantial improvement in clinical benefit over the
control group with statistical significance. On August 15, 2016, we announced updated results from its final retrospective OS
analysis of the data from the HEAT Study. These results demonstrated that in a large, well bounded, subgroup of patients with
a single lesion (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided
an average 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio, or HR, at this analysis is 0.65 (95%
CI 0.45 - 0.94) with a p-value of 0.02. Median OS for the ThermoDox® group has been reached which translates into a two-year
survival benefit over the optimized RFA group (projected to be greater than 80 months for the ThermoDox® plus optimized RFA
group compared to less than 60 months projection for the optimized RFA only group).
While
this information should be viewed with caution since it is based on a retrospective analysis of a subgroup, we also conducted
additional analyses that further strengthen the evidence for the HEAT Study subgroup. We commissioned an independent computational
model at the University of South Carolina Medical School. The results unequivocally indicate that longer RFA heating times correlate
with significant increases in doxorubicin concentration around the RFA treated tissue. In addition, we conducted a prospective
preclinical study in 22 pigs using two different manufacturers of RFA and human equivalent doses of ThermoDox® that clearly
support the relationship between increased heating duration and doxorubicin concentrations.
We
completed enrollment of 556 patients in the Phase III OPTIMA Study in August 2018. Data for the study will be reviewed as it matures
up to two interim analyses expected to be conducted in the fourth quarter of 2019 and in the first half of 2020. We expect that
the final efficacy analysis, if necessary, will be completed in the first half of 2021. If the study proves to provide a clinically
meaningful improvement in overall survival, we will immediately apply for marketing authorization in the US, Europe and China.
ThermoDox® has received U.S. FDA Fast Track Designation and has been granted orphan drug designation for primary liver cancer
in both the U.S. and the EU. Additionally, the U.S. FDA has provided ThermoDox® with a 505(b)(2) registration pathway. Subject
to a successful trial, the OPTIMA Study has been designed to support registration in all key primary liver cancer markets. We
fully expect to submit registrational applications in the U.S., Europe and China. We expect to submit and believes that applications
will be accepted in South Korea, Taiwan and Vietnam, three other significant markets for ThermoDox® if it were to receive
approval in Europe, China or the U.S.
On
December 18, 2018, we announced that the DMC for the OPTIMA Study completed its last scheduled review of all patients enrolled
in the trial and unanimously recommended that the OPTIMA Study continue according to protocol to its final data readout. The DMC’s
recommendation was based on the Committee’s assessment of safety and data integrity of all patients randomized in the trial
as of October 4, 2018. The DMC reviewed study data at regular intervals throughout the patient enrollment period, with the primary
responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected, and the continued
scientific validity of the study design. As part of its review of all 556 patients enrolled into the trial, the DMC evaluated
a quality matrix relating to the total clinical data set, confirming the timely collection of data, that all data are current
as well as other data collection and quality criteria.
On
August 5, 2019, the Company announced that the prescribed number of events has been reached for the first prespecified interim
analysis of the OPTIMA Phase III Study with ThermoDox® plus RFA in patients with HCC, or primary liver cancer. Following preparation
of the data, the first interim analysis was conducted by the Independent Data Monitoring Committee (iDMC) on November 1, 2019.
This timeline was consistent with the Company’s stated expectations and is necessary to provide a full and comprehensive
data set that may represent the potential for a successful trial outcome. In accordance with the statistical plan, this initial
interim analysis has a target of 118 events, or 60% of the total number required for the final analysis. At the time of the data
cutoff, the Company received reports of 128 events. The hazard ratio for success at 128 events is approximately 0.63, which represents
a 37% reduction in the risk of death compared with RFA alone and is consistent with the 0.65 hazard ratio that was observed in
the prospective HEAT Study subgroup, which demonstrated a two-year overall survival advantage and a median time to death of more
than seven and a half years.
On
November 4, 2019, the Company announced that the independent Data Monitoring Committee (iDMC) unanimously recommended the OPTIMA
Study continue according to protocol. The recommendation was based on a review of blinded safety and data integrity from 556 patients
enrolled in the Company’s multinational, double-blind, placebo-controlled pivotal Phase III study with ThermoDox® plus
RFA in patients with hepatocellular carcinoma (HCC), or primary liver cancer.
The
iDMC’s pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred in August 2018. Data presented
demonstrated that PFS and OS data appear to be tracking with patient data observed at a similar point in the Company’s subgroup
of patients followed prospectively in the earlier Phase III HEAT Study, upon which the OPTIMA Study is based.
The
data review demonstrated the following:
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The
OPTIMA Study patient demographics and risk factors are consistent with what the Company observed in the HEAT Study subgroup
with all data quality metrics meeting expectations.
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Median
PFS for the OPTIMA Study reached 17 months as of August 2019. These blinded data compare favorably with 16 months median PFS
for the 285 patients in the HEAT Study subgroup of patients treated with RFA >45 minutes and followed prospectively for
overall survival.
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Median
OS for the OPTIMA Study has not been reached as of August 5, 2019, however median OS appears to be consistent with the HEAT
Study subgroup of patients treated with RFA >45 minutes and followed prospectively for overall survival.
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The
OPTIMA Study has lost only 4 patients to follow-up from the initiation of the trial in September 2014 through August 2019
while the trial design allows for 3% risk for loss per year, which at this point would have exceeded 60 patients.
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While the
Company has not unblinded the study to report a hazard ratio, PFS and OS are tracking similarly to the subgroup of patients who
received more than 45 minutes of RFA in our HEAT Study and followed prospectively for more than three years. This subgroup in
the HEAT study demonstrated a 2-year overall survival advantage and a median time to death of more than 7 ½ years. This
tracking appears to bode well for success at the next pre-planned interim efficacy analysis, which is intended after a minimum
of 158 patient deaths and is projected to occur during the second quarter of 2020. The hazard ratio for success at 158 events
is 0.70. This is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with
RFA > 45 minutes.
On
August 13, 2019, we announced that results from an independent analysis of our ThermoDox® HEAT Study conducted
by the National Institutes of Health, or NIH, were published in the peer-reviewed publication, Journal of Vascular and Interventional
Radiology. The analysis was conducted by the intramural research program of the NIH and the NIH Center for Interventional
Oncology (CIO), with the full data set from the Company’s HEAT Study. The analysis evaluated the full data set to determine
if there was a correlation between baseline tumor volume and radiofrequency ablation (RFA) heating time (minutes/tumor volume
in milliliters), with or without ThermoDox® treatment, for patients with HCC. The NIH analysis was conducted under the direction
of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology.
The
article titled, “RFA Duration Per Tumor Volume May Correlate With Overall Survival in Solitary Hepatocellular Carcinoma
Patients Treated With RFA Plus Lyso-thermosensitive Liposomal Doxorubicin,” discussed the NIH analysis of results from
437 patients in the HEAT Study (all patients with a single lesion representing 62.4% of the study population). The key finding
was that increased RFA heating time per tumor volume significantly improved overall survival (OS) in patients with single-lesion
HCC who were treated with RFA plus ThermoDox®, compared to patients treated with RFA alone. A one-unit increase
in RFA duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox®,
compared to RFA alone. The authors conclude that increasing RFA heating time in combination with ThermoDox® significantly
improves OS and establishes an improvement of over two years versus the control arm when the heating time per milliliter of tumor
is greater than 2.5 minutes. This finding is consistent with the Company’s own results, which defined the optimized RFA
procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lends support to the hypothesis
underpinning the OPTIMA Study.
On
August 27, 2019, the Company announced that a study from a single site in China titled “Thermosensitive liposomal doxorubicin
plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular
carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single center” has been published in the Journal
of Cancer Research and Therapeutics. These data were generated as part of the Phase III HEAT (Hepatocellular Carcinoma Study
of RFA and ThermoDox®) Study sponsored by Celsion Corporation. The data from this single site at the Peking University
Cancer Hospital and Institute in Beijing show an overall survival (OS) improvement of 22.5 months in patients with 3-7 cm unresectable
hepatocellular carcinoma (HCC) tumors receiving combined radiofrequency ablation (RFA) and ThermoDox®, compared
with the use of RFA alone.
In
this study, patients received 50 mg/m2 of ThermoDox® or placebo, plus RFA for 45 minutes or longer.
Patients were followed for 11 to 80 months (average: 49.1 ± 24.8 months), with 18 of 22 patients completing the study.
The mean OS for the ThermoDox® plus RFA group was 68.5 ± 7.2 months, which was significantly greater than
the placebo plus RFA group (46.0 ± 10.6 months, pValue = 0.045). At the end of the follow-up period, the percentage of
patients alive after 1, 3 and 5 years were as follows:
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ThermoDox + RFA
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RFA Alone
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% of patients alive at 1 year
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90.0
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%
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87.5
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%
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% of patients alive at 3 years
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90.0
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%
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50.0
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%
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% of patients alive at 5 years
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77.1
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%
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37.5
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%
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The publication
can be found in the Journal of Cancer Research and Therapeutics | Year: 2019 | Volume: 15 | Issue: 4 | Page 773 –
783. The authors are Yang W, Lee JC, Chen MH, Zhang ZY, Bai XM, Yin SS, et al. from the Departments of Ultrasound and Radiology,
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute
in Beijing. Professor Min-Hua Chen was a principal investigator in Celsion’s Phase III HEAT Study, from which these data
are derived, and is also a principal investigator in the Company’s ongoing Phase III OPTIMA Study for the treatment of primary
liver cancer with ThermoDox® plus standardized RFA.
The
HEAT Study. On January 31, 2013, we announced that the HEAT Study, ThermoDox® in combination with RFA, did
not meet the primary endpoint, PFS, in the Phase III clinical trial enrolling 701 patients with primary liver cancer. This determination
was made after conferring with the HEAT Study independent DMC, that the HEAT Study did not meet the goal of demonstrating a clinically
meaningful improvement in progression free survival. In the trial, ThermoDox® was well-tolerated with no unexpected serious
adverse events. Following the announcement of the HEAT Study results, we continued to follow patients for OS, the secondary endpoint
of the HEAT Study. We have conducted a comprehensive analysis of the data from the HEAT Study to assess the future strategic value
and development strategy for ThermoDox®.
Acquisition
of EGEN Assets
On
June 20, 2014, we completed the acquisition of substantially all of the assets of EGEN, which has changed its company name to
EGWU, Inc. after the closing of the acquisition, pursuant to an Asset Purchase Agreement dated as of June 6, 2014, by and between
us and EGEN, or the Asset Purchase Agreement. We acquired all of EGEN’s right, title and interest in and to substantially
all of the assets of EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical
data, certain contracts, licenses and permits, equipment, furniture, office equipment, furnishings, supplies and other tangible
personal property. In addition, CLSN Laboratories assumed certain specified liabilities of EGEN, including the liabilities arising
out of the acquired contracts and other assets relating to periods after the closing date.
At
the time of the acquisition, the total purchase price for the asset acquisition was up to $44.4 million, including potential future
earnout payments of up to $30.4 million contingent upon achievement of certain earnout milestones set forth in the Asset Purchase
Agreement. We paid approximately $3.0 million in cash after the expense adjustment and issued 241,590 shares of our common stock
to EGEN. The shares of common stock were issued in a private transaction exempt from registration under the Securities Act, pursuant
to Section 4 (2) thereof.
On
March 28, 2019, the Company entered into an amendment to the Asset Purchase Agreement, or the Amended Asset Purchase Agreement)
with EGWU, Inc. Pursuant to the Amended Asset Purchase Agreement, payment of the earnout milestone liability related to the Ovarian
Cancer Indication of $12.4 million has been modified. The Company has the option to make the payment as follows:
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a)
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$7.0
million in cash within 10 business days of achieving the milestone; or
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b)
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$12.4
million in cash, common stock of the Company, or a combination of either, within one year of achieving the milestone.
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The
Company provided EGWU, Inc. 200,000 warrants to purchase common stock at a strike price of $0.01 per warrant share as consideration
for entering into this amended agreement. The warrant shares have no expiration and were fair valued at $2.00 using the closing
price of our common stock on the date of issuance offset by the exercise price and were recorded as a non-cash expense in the
income statement and classified as equity on the balance sheet.
GEN-1
GEN-1
is a DNA-based immunotherapeutic product candidate for the localized treatment of ovarian cancer by intraperitoneally administering
an Interleukin-12, or IL-12,) plasmid formulated with our proprietary TheraPlas delivery system. In this DNA-based approach, the
immunotherapy is combined with a standard chemotherapy drug, which can potentially achieve better clinical outcomes than with
chemotherapy alone. We believe that increases in IL-12 concentrations at tumor sites for several days after a single administration
could create a potent immune environment against tumor activity and that a direct killing of the tumor with concomitant use of
cytotoxic chemotherapy could result in a more robust and durable antitumor response than chemotherapy alone. We believe the rationale
for local therapy with GEN-1 is based on the following.
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Loco-regional
production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with systemic delivery of recombinant
IL-12;
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Persistent
local delivery of IL-12 lasts up to one week and dosing can be repeated; and
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Ideal
for long-term maintenance therapy.
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OVATION
Study
In
February 2015, we announced that the FDA accepted, without objection, the Phase Ib dose-escalation clinical trial of GEN-1 in
combination with the standard of care in neo-adjuvant ovarian cancer, or the OVATION Study. On September 30, 2015, we announced
enrollment of the first patient in the OVATION Study. The OVATION Study was designed (i) to identify a safe, tolerable and potentially
therapeutically active dose of GEN-1 by recruiting and maximizing an immune response and (ii) to enroll three to six patients
per dose level to evaluate safety and efficacy and attempt to define an optimal dose for a follow-on Phase II study. In addition,
the OVATION Study establishes a unique opportunity to assess how cytokine-based compounds such as GEN-1 directly affect ovarian
cancer cells and the tumor microenvironment in newly diagnosed patients. The study was designed to characterize the nature of
the immune response triggered by GEN-1 at various levels of the patients’ immune system, including:
We
initiated the OVATION Study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center,
Washington University in St. Louis and the Medical College of Wisconsin. During 2016 and 2017, we announced data from the first
fourteen patients in the OVATION Study who completed treatment. On October 3, 2017 and again on March 2, 2109, we announced final
clinical and translational research data from the OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1 with
the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo
neoadjuvant chemotherapy followed by interval debulking surgery.
We
reported positive clinical data from the first fourteen patients who have completed treatment in the OVATION Study. GEN-1 plus
standard chemotherapy produced positive clinical results, with no dose limiting toxicities and positive dose dependent efficacy
signals which correlate well with positive surgical outcomes. The OVATION Study evaluated escalating doses of GEN-1 (36 mg/m2,
47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles
of neoadjuvant chemotherapy prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed
patients with Stage III/IV ovarian cancer.
In
this Phase IB dose-escalation study, the 14 patients who were evaluable for response demonstrated median PFS of 21 months in patients
treated per protocol and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients
who dropped out of the study after 13 days or less, and two patients who did not receive full NAC and GEN-1 cycles. In addition,
100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial
or complete response) compared to only 60% of patients given the two lower doses. Pathological changes were assessed as part of
the study, with the density of markers measured in tissue sections assessed via immunohistochemistry staining. Dose-limiting toxicity
was not reached in the OVATION I Study.
OVATION
2 Study
On November 13, 2017, the Company filed
its Phase I/II clinical trial protocol with the U.S. Food and Drug Administration for GEN-1 for the localized treatment of ovarian
cancer. The protocol is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of
GEN-1 while maximizing an immune response. The Phase I portion of the study will be followed by a continuation at the selected
dose in 130 patients randomized Phase II study. On November 5, 2019, the Company announced that the independent Data Safety Monitoring
Board (DSMB) completed its safety review of data from the first eight patients enrolled in the ongoing Phase I/II OVATION 2 Study.
Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with completing enrollment
in the Phase I portion of the trial.
In the OVATION 2 Study, patients in the
GEN-1 treatment arm will receive GEN-1 plus chemotherapy pre- and post-interval debulking surgery. The OVATION 2 Study will include
up to 130 patients with Stage III/IV ovarian cancer, with 12 to 15 patients in the Phase I portion and up to 118 patients in Phase
II. The study is powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant + adjuvant
chemotherapy versus neoadjuvant + adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events
have been observed or after all patients have been followed for at least 16 months, whichever is later.
Developed with extensive input from
the Company's Medical Advisory Board, the OVATION 2 Study builds on promising clinical and translational research data from the
Phase IB dose-escalation OVATION I Study, in which enrolled patients received escalating weekly doses of GEN-1 up to 79 mg/m²
for a total of eight treatments in combination with NACT, followed by IDS. In addition to exploring a higher dose of GEN-1 in
the OVATION 2 study, patients will continue to receive GEN-1 after their IDS in combination with adjuvant chemotherapy.
The latest DSMB review of GEN-1 at 100
mg/m² has confirmed that there were no dose limiting toxicities detected in any of the five patients dosed with GEN-1 and
that intraperitoneal administration is well tolerated even when given with standard NACT. “Of the eight patients treated
in the Phase I portion of the OVATION 2 Study, five patients were treated with GEN-1 plus NACT and three patients were treated
with NACT only.
Because
of the risks and uncertainties discussed in this Annual Report on Form 10-K, among others, we are unable to estimate the duration
and completion costs of our research and development projects or when, if ever, and to what extent we will receive cash inflows
from the commercialization and sale of a product. Our inability to complete any of our research and development activities, preclinical
studies or clinical trials in a timely manner or our failure to enter into collaborative agreements when appropriate could significantly
increase our capital requirements and could adversely impact our liquidity. While our estimated future capital requirements are
uncertain and could increase or decrease as a result of many factors, including the extent to which we choose to advance our research,
development activities, preclinical studies and clinical trials, or if we are in a position to pursue manufacturing or commercialization
activities, we will need significant additional capital to develop our product candidates through development and clinical trials,
obtain regulatory approvals and manufacture and commercialize approved products, if any. We do not know whether we will be able
to access additional capital when needed or on terms favorable to us or our stockholders. Our inability to raise additional capital,
or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
TheraPlas
Technology Platform. TheraPlas is a technology platform for the delivery of DNA and messenger RNA, or mRNA, therapeutics
via synthetic non-viral carriers and is capable of providing cell transfection for double-stranded DNA plasmids and large therapeutic
RNA segments such as mRNA. There are two components of the TheraPlas system, a plasmid DNA or mRNA payload encoding a therapeutic
protein and a delivery system. The delivery system is designed to protect the DNA/RNA from degradation and promote trafficking
into cells and through intracellular compartments. We designed the delivery system of TheraPlas by chemically modifying the low
molecular weight polymer to improve its gene transfer activity without increasing toxicity. We believe TheraPlas is a viable alternative
to current approaches to gene delivery due to several distinguishing characteristics, including enhanced molecular versatility
that allows for complex modifications to improve activity and safety.
On
August 8, 2016, we signed the GEN-1 Agreement with Hisun to pursue an expanded partnership for the technology transfer relating
to the clinical and commercial manufacture and supply of GEN-1, Our proprietary gene mediated, IL-12 immunotherapy, for the China
territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are
obtained. The GEN-1 Agreement will help to support supply for both ongoing and planned clinical studies in the U.S. and for potential
future studies of GEN-1 in China. We are currently evaluating GEN-1 in first line ovarian cancer patients.
In
June 2012, we and Hisun signed a long-term commercial supply agreement for the production of ThermoDox®. Hisun is one the
largest manufacturers of chemotherapy agents globally, including doxorubicin. In July 2013, the ThermoDox® collaboration was
expanded to focus on next generation liposomal formulation development with the goal of creating safer, more efficacious versions
of marketed cancer chemotherapeutics. During 2015, Hisun successfully completed the manufacture of three registration batches
for ThermoDox® and has obtained regulatory approvals to supply ThermoDox® to participating clinical trial sites in all
of the countries of South East Asia and North America, as well as to the European Union countries allowing for early access to
ThermoDox®. The future manufacturing of clinical and commercial supplies by Hisun will result in a cost structure allowing
us to profitably access all global markets, including third world countries, and help accelerate the Company’s product development
program in China for ThermoDox® in primary liver cancer and other approved indications.
Corporate
Information
We
were founded in 1982 and is a Delaware corporation. Our principal executive offices are located at 997 Lenox Drive, Suite 100,
Lawrenceville, NJ 08648. Our telephone number is (609) 896-9100. Our website is www.celsion.com. The information contained on
or that can be accessed through our website is not incorporated by reference into this prospectus, and you should not consider
information on our website to be part of this prospectus or in deciding to purchase our common stock.
The
Offering
Common
stock being offered by the selling stockholder
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4,500,000
shares
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Common
stock outstanding
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22,002,418
(as of September 30, 2019, excluding the Commitment Shares, as defined below).
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Use
of proceeds
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The
selling stockholder will receive all of the proceeds from the sale of the shares offered for sale by it under this prospectus.
We will not receive proceeds from the sale of the shares by the selling stockholder. However, we may receive up to $10.0 million
in proceeds from the sale of our common stock to the selling stockholder under the common stock purchase agreement described
below. Any proceeds from the selling stockholder that we receive under the purchase agreement are expected be used for working
capital and general corporate purposes.
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Nasdaq
Symbol
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CLSN
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Risk
Factors
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Investing
in our securities involves a high degree of risk. You should carefully review and consider the “Risk Factors”
section of this prospectus for a discussion of factors to consider before deciding to invest in shares of our common stock.
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The
number of shares of our common stock outstanding is based on an aggregate of 22,002,418 shares of our common stock outstanding
as of September 30, 2019 and
excludes the 100,000 Commitment Shares as defined below, and also excludes:
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3,951,142
shares of common stock issuable upon the exercise of outstanding options as of September
30, 2019, having a weighted average exercise price of $2.56 per
share;
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21,750
shares of common stock issuable upon the vesting of common stock awards as of September 30, 2019, having a weighted average
grant day fair value of $2.22 per share;
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626,098
shares of common stock issuable upon the exercise of outstanding warrants as of September
30, 2019 having a weighted average exercise price of $1.87 per share; and
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854,507
shares of common stock reserved for future issuance pursuant to our existing stock incentive
plan.
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Common
Stock Issued and Issuable to the Selling Stockholder
On
October 28, 2019, we entered into a common stock purchase agreement (referred to in this prospectus as the “Purchase Agreement”),
with Aspire Capital Fund, LLC, an Illinois limited liability company (referred to in this prospectus as “Aspire Capital”
or the “selling stockholder”), which provides that, upon the terms and subject to the conditions and limitations set
forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of our shares of common stock over
the approximately 24-month term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently
with the execution of the Purchase Agreement, we issued to Aspire Capital 100,000 shares of our common stock as a commitment fee
(referred to in this prospectus as the “Commitment Shares”). Concurrently with entering into the Purchase Agreement,
we also entered into a registration rights agreement with Aspire Capital (referred to in this prospectus as the “Registration
Rights Agreement”), in which we agreed to file one or more registration statements, including the registration statement
of which this prospectus is a part, as permissible and necessary to register under the Securities Act of 1933, as amended, or
the Securities Act, the sale of the shares of our common stock that have been and may be issued to Aspire Capital under the Purchase
Agreement.
As
of October 28, 2019, there were 22,655,818 shares of our common stock outstanding excluding the 4,500,000 shares offered that
have been issued or may be issuable to Aspire Capital pursuant to the Purchase Agreement. If all of such shares of our common
stock offered hereby were issued and outstanding as of the date hereof, such shares would represent 19.99% of the total common
stock outstanding as of the date hereof. The number of shares of our common stock ultimately offered for sale by Aspire Capital
is dependent upon the number of shares purchased by Aspire Capital under the Purchase Agreement.
Pursuant
to the Purchase Agreement and the Registration Rights Agreement, we are registering 4,500,000 shares of our common stock under
the Securities Act, which includes the Commitment Shares that have already been issued to Aspire Capital and 4,400,000 shares
of common stock which we may issue to Aspire Capital after this registration statement is declared effective under the Securities
Act. All 4,500,000 shares of common stock are being offered pursuant to this prospectus.
After
the Securities and Exchange Commission has declared effective the registration statement of which this prospectus is a part, on
any trading day on which the closing sale price of our common stock exceeds $0.25, we have the right, in our sole discretion,
to present Aspire Capital with a purchase notice (each, a “Purchase Notice”), directing Aspire Capital (as principal)
to purchase up to 100,000 shares of our common stock per trading day, up to $10.0 million of our common stock in the aggregate
at a per share price (the “Purchase Price”) calculated by reference to the prevailing market price of our common stock
(as more specifically described below).
In
addition, on any date on which we submit a Purchase Notice for 100,000 shares to Aspire Capital, we also have the right, in our
sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP Purchase
Notice”) directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s
common stock traded on Nasdaq on the next trading day (the “VWAP Purchase Date”), subject to a maximum number of shares
we may determine (the “VWAP Purchase Share Volume Maximum”) and a minimum trading price (the “VWAP Minimum Price
Threshold”) (as more specifically described below). The purchase price per Purchase Share pursuant to such VWAP Purchase
Notice (the “VWAP Purchase Price”) is calculated by reference to the prevailing market price of our common stock (as
more specifically described below). The respective prices and share numbers in the preceding paragraphs shall be appropriately
adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.
The
Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any
purchase date where the closing sale price of our common stock is less than $0.25 per share (the “Floor Price”). There
are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of
any sales of our common stock to Aspire Capital. Aspire Capital has no right to require any sales by us, but is obligated to make
purchases from us as we direct in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial
or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated
damages in the Purchase Agreement. Aspire Capital may not assign its rights or obligations under the Purchase Agreement. The Purchase
Agreement may be terminated by us at any time, at our discretion, without any penalty or cost to us.
Risk
Factors
You
should carefully consider the following information about risks, together with the other information contained in this prospectus,
before making an investment in our common stock. If any of the circumstances or events described below actually arises or occurs,
our business, results of operations, cash flows and financial condition could be harmed. In any such case, the market price of
our common stock could decline, and you may lose all or part of your investment.
Risks
Related to This Offering
We
will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds
when needed and on acceptable terms.
The
extent to which we utilize the Purchase Agreement with Aspire Capital as a source of funding will depend on a number of factors,
including the prevailing market price of our common stock, the volume of trading in our common stock and the extent to which we
are able to secure funds from other sources. The number of shares that we may sell to Aspire Capital under the Purchase Agreement
on any given day and during the term of the agreement is limited. See “The Aspire Capital Transaction” section of
this prospectus for additional information. Additionally, we and Aspire Capital may not effect any sales of shares of our common
stock under the Purchase Agreement during the continuance of an event of default or on any trading day that the closing sale price
of our common stock is less than $0.25 per share. Even if we are able to access the full $10.0 million under the Purchase
Agreement, we will still need additional capital to fully implement our business, operating and development plans.
The
sale of our common stock to Aspire Capital may cause substantial dilution to our existing stockholders and the sale of the shares
of common stock acquired by Aspire Capital could cause the price of our common stock to decline.
We
are registering for sale the Commitment Shares that we have issued and 4,400,000 shares that we may sell to Aspire Capital under
the Purchase Agreement. It is anticipated that shares registered in this offering will be sold over a period of up to approximately
24 months from the date of this prospectus. The number of shares ultimately offered for sale by Aspire Capital under this prospectus
is dependent upon the number of shares we elect to sell to Aspire Capital under the Purchase Agreement. Depending on a variety
of factors, including market liquidity of our common stock, the sale of shares under the Purchase Agreement may cause the trading
price of our common stock to decline.
Aspire
Capital may ultimately purchase all, some or none of the $10.0 million of common stock that, together with the Commitment Shares,
is the subject of this prospectus. Aspire Capital may sell all, some or none of our shares that it holds or comes to hold under
the Purchase Agreement. Sales by Aspire Capital of shares acquired pursuant to the Purchase Agreement under the registration statement,
of which this prospectus is a part, may result in dilution to the interests of other holders of our common stock. The sale of
a substantial number of shares of our common stock by Aspire Capital in this offering, or anticipation of such sales, could cause
the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities
in the future at a time and at a price that we might otherwise desire. However, we have the right under the Purchase Agreement
to control the timing and amount of sales of our shares to Aspire Capital, and the Purchase Agreement may be terminated by us
at any time at our discretion without any penalty or cost to us.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained or incorporated by reference in this prospectus, in any applicable prospectus and in any related free writing
prospectus constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and
releases issued by the SEC and within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act),
and Section 21E of the Exchange Act. From time to time, we may publish forward-looking statements relating to such matters as
anticipated financial performance, business prospects, technological developments, product pipelines, clinical trials and research
and development activities, the adequacy of capital reserves and anticipated operating results and cash expenditures, current
and potential collaborations, strategic alternatives and other aspects of our present and future business operations and similar
matters that also constitute such forward-looking statements. These statements involve known and unknown risks, uncertainties
and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to
be materially different from any future results, levels of activity, performance or achievements expressed or implied by such
forward-looking statements. Such statements include, without limitation:
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any
statements regarding future operations, plans, regulatory filings or approvals, including
the plans and objectives of management for future operations or programs or proposed
new products or services;
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any
statements regarding the performance, or likely performance, or outcomes or economic
benefit of any of our research and development activities, proposed or potential clinical
trials or new drug filing strategies or timelines, including whether any of our clinical
trials will be completed successfully within any specified time period or at all;
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any
projections of earnings, cash resources, revenue, expense or other financial terms;
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any
statements regarding the initiation, timing, progress and results of our research and
development programs, preclinical studies, any clinical trials and Investigational New
Drug application, New Drug Application and other regulatory submissions;
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any
statements regarding cost and timing of development and testing, capital structure, financial
condition, working capital needs and other financial items;
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any
statements regarding the implementation of our business model and integration of acquired
technologies, assets or businesses and existing or future collaborations, mergers, acquisitions
or other strategic transactions;
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any
statements regarding approaches to medical treatment, any introduction of new products
by others, any possible licenses or acquisitions of other technologies, assets or businesses,
or possible actions by customers, suppliers, strategic partners, potential strategic
partners, competitors or regulatory authorities;
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any
statements regarding development or success of our collaboration arrangements or future
payments that may come due to us under these arrangements;
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any
statements
regarding compliance with the listing standards of The Nasdaq Capital Market; and
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any
statements regarding future economic conditions or performance and any statement of assumptions
underlying any of the foregoing.
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In
some cases, you can identify forward-looking statements by terminology such as “expect,” “anticipate,”
“estimate,” “continue,” “plan,” “believe,” “could,” “intend,”
“predict,” “may,” “should,” “will,” “would” and words of similar import
regarding our expectations. Forward-looking statements are only predictions. Actual events or results may differ materially. Although
we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our industry, business
and operations, we cannot guarantee that actual results will not differ materially from our expectations. In evaluating such forward-looking
statements, you should specifically consider various factors, including the risks outlined under “Risk Factors” contained
in this prospectus and any related free writing prospectus, and in our most recent Annual Report on Form 10-K and our most recent
filed Quarterly Reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. The discussion
of risks and uncertainties set forth in those filings is not necessarily a complete or exhaustive list of all risks facing us
at any particular point in time. We operate in a highly competitive, highly regulated and rapidly changing environment, and our
business is in a state of evolution. Therefore, it is likely that new risks will emerge and the nature and elements of existing
risks will change. It is not possible for management to predict all such risk factors or changes therein or to assess either the
impact of all such risk factors on our business or the extent to which any individual risk factor, combination of factors or new
or altered factors may cause results to differ materially from those contained in any forward-looking statement. Forward-looking
statements represent our estimates and assumptions only as of the date such forward-looking statements are made. You should carefully
read this prospectus supplement and any related free writing prospectus, together with the information incorporated herein or
therein by reference as described under the section titled “Information Incorporated By Reference,” and with the understanding
that our actual future results may materially differ from what we expect.
Except
as required by law, forward-looking statements speak only as of the date they are made, and we assume no obligation to update
any forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated
in any forward-looking statements, even if new information becomes available.
The
Aspire Capital Transaction
General
On
October 28, 2019, we entered into the Purchase Agreement which provides that, upon the terms and subject to the conditions and
limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of our shares of common
stock over the term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the
execution of the Purchase Agreement, we issued to Aspire Capital the Commitment Shares. Concurrently with entering into the Purchase
Agreement, we also entered into the Registration Rights Agreement, in which we agreed to file one or more registration statements
as permissible and necessary to register under the Securities Act, the sale of the shares of our common stock that have been and
may be issued to Aspire Capital under the Purchase Agreement.
As
of October 28, 2019, there were 22,655,818 shares of our common stock outstanding (168,672 shares held by affiliates) excluding
the 4,500,000 shares offered that may be issuable to Aspire Capital pursuant to the Purchase Agreement. If all of such 4,500,000
shares of our common stock offered hereby were issued and outstanding as of the date hereof, such shares would represent 19.99%
of the total common stock outstanding or 20.00% of the non-affiliate shares of common stock outstanding as of the date hereof.
The number of shares of our common stock ultimately offered for sale by Aspire Capital is dependent upon the number of shares
purchased by Aspire Capital under the Purchase Agreement.
Pursuant
to the Purchase Agreement and the Registration Rights Agreement, we are registering 4,500,000 shares of our common stock under
the Securities Act, which includes the Commitment Shares that have already been issued to Aspire Capital and 4,400,000 shares
of common stock which we may issue to Aspire Capital after this registration statement is declared effective under the Securities
Act. All 4,500,000 shares of common stock are being offered pursuant to this prospectus. Under the Purchase Agreement, we have
the right but not the obligation to issue more than the 4,400,000 shares of common stock included in this prospectus to Aspire
Capital. As of the date hereof, we do not have any plans or intent to issue to Aspire Capital any shares of common stock in addition
to the 4,500,000 shares of common stock offered hereby.
After
the Securities and Exchange Commission has declared effective the registration statement of which this prospectus is a part, on
any trading day on which the closing sale price of our common stock is not less than $0.25 per share, we have the right, in our
sole discretion, to present Aspire Capital with a Purchase Notice, directing Aspire Capital (as principal) to purchase up to 100,000
shares of our common stock per business day, up to $10.0 million of our common stock in the aggregate over the term of the Purchase
Agreement, at a Purchase Price calculated by reference to the prevailing market price of our common stock over the preceding 10-business
day period (as more specifically described below); however, no sale pursuant to a Purchase Notice may exceed $500,000 per trading
day.
In
addition, on any date on which we submit a Purchase Notice to Aspire Capital for 100,000 Purchase Shares, we also have the right,
in our sole discretion, to present Aspire Capital with a VWAP Purchase Notice directing Aspire Capital to purchase an amount of
stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on the Nasdaq Capital Market on the
next trading day, subject to the VWAP Purchase Share Volume Maximum and the VWAP Minimum Price Threshold. The VWAP Purchase Price
is calculated by reference to the prevailing market price of our common stock (as more specifically described below).
The
Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any
purchase date where the closing sale price of our common stock is less than the Floor Price. There are no trading volume requirements
or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Aspire
Capital. Aspire Capital has no right to require any sales by us, but is obligated to make purchases from us as we direct in accordance
with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future
financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. Aspire Capital
may not assign its rights or obligations under the Purchase Agreement. The Purchase Agreement may be terminated by us at any time,
at our discretion, without any penalty or cost to us.
Purchase
Of Shares Under The Common Stock Purchase Agreement
Under
the common stock Purchase Agreement, on any trading day selected by us on which the closing sale price of our common stock exceeds
$0.25 per share, we may direct Aspire Capital to purchase up to 100,000 shares of our common stock per trading day. The Purchase
Price of such shares is equal to the lesser of:
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the
lowest sale price of our common stock on the purchase date; or
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the
arithmetic average of the three lowest closing sale prices for our common stock during
the ten consecutive trading days ending on the trading day immediately preceding the
purchase date.
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In
addition, on any date on which we submit a Purchase Notice to Aspire Capital for purchase of 100,000 shares, we also have the
right to direct Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of our common stock traded
on the Nasdaq Capital Market on the next trading day, subject to the VWAP Purchase Share Volume Maximum and the VWAP Minimum Price
Threshold, which is equal to the greater of (a) 80% of the closing price of the Company’s common stock on the business day
immediately preceding the VWAP Purchase Date or (b) such higher price as set forth by the Company in the VWAP Purchase Notice.
The VWAP Purchase Price of such shares is the lower of:
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the
Closing Sale Price on the VWAP Purchase Date; or
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97%
of the volume-weighted average price for our common stock traded on the Nasdaq Capital
Market:
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on
the VWAP Purchase Date, if the aggregate shares to be purchased on that date have not
exceeded the VWAP Purchase Share Volume Maximum or
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during
that portion of the VWAP Purchase Date until such time as the sooner to occur of (i)
the time at which the aggregate shares traded on the Nasdaq Capital Market exceed the
VWAP Purchase Share Volume Maximum or (ii) the time at which the sale price of the Company’s
common stock falls below the VWAP Minimum Price Threshold.
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The
Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction
occurring during the trading day(s) used to compute the Purchase Price. We may deliver multiple Purchase Notices and VWAP Purchase
Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has
been completed.
Minimum
Share Price
Under
the Purchase Agreement, we and Aspire Capital may not effect any sales of shares of our common stock under the Purchase Agreement
on any trading day that the closing sale price of our common stock is less than $0.25 per share.
Events
of Default
No
sales are permitted to be made under the Purchase Agreement upon the occurrence of any of the following, among other, events of
default:
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the
effectiveness of any registration statement that is required to be maintained effective
pursuant to the terms of the Registration Rights Agreement between us and Aspire Capital
lapses for any reason (including, without limitation, the issuance of a stop order) or
is unavailable to Aspire Capital for sale of our shares of common stock, and such lapse
or unavailability continues for a period of ten consecutive business days or for more
than an aggregate of thirty business days in any 365-day period, which is not in connection
with a post-effective amendment to any such registration statement; in connection with
any post-effective amendment to such registration statement that is required to be declared
effective by the SEC such lapse or unavailability may continue for a period of no more
than 30 consecutive business days;
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the
suspension from trading or failure of our common stock to be listed on our principal
market for a period of three consecutive business days;
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the
delisting of our common stock from our principal market, provided our common stock is
not immediately thereafter trading on the New York Stock Exchange, the NYSE American,
the Nasdaq Capital Market, the Nasdaq Global Select Market, or the Nasdaq Global Market;
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our
transfer agent’s failure to issue to Aspire Capital shares of our common stock
which Aspire Capital is entitled to receive under the Purchase Agreement within five
business days after an applicable purchase date;
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any
breach by us of the representations or warranties or covenants contained in the Purchase
Agreement or any related agreements which could have a material adverse effect on us,
subject to a cure period of five business days;
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if
we become insolvent or are generally unable to pay our debts as they become due; or
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any
participation or threatened participation in insolvency or bankruptcy proceedings by
or against us.
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The
Purchase Agreement will be automatically terminated in the event of any participation in insolvency or bankruptcy proceedings
by or against us.
Our
Termination Rights
The
Purchase Agreement may be terminated by us at any time, at our discretion, without any penalty or cost to us.
No
Short-Selling or Hedging by Aspire Capital
Aspire
Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect
short-selling or hedging of our common stock during any time prior to the termination of the Purchase Agreement.
Effect
of Performance of the Purchase Agreement on Our Stockholders
The
Purchase Agreement does not limit the ability of Aspire Capital to sell any or all of the 4,500,000 shares registered in this
offering. It is anticipated that shares registered in this offering will be sold over a period of up to approximately thirty months
from the date of this prospectus. The sale by Aspire Capital of a significant amount of shares registered in this offering at
any given time could cause the market price of our common stock to decline and/or to be highly volatile. Aspire Capital may ultimately
purchase all, some or none of the 4,400,000 shares of common stock not yet issued but registered in this offering. After it has
acquired such shares, it may sell all, some or none of such shares. Therefore, sales to Aspire Capital by us pursuant to the Purchase
Agreement also may result in substantial dilution to the interests of other holders of our common stock. However, we have the
right to control the timing and amount of any sales of our shares to Aspire Capital and the Purchase Agreement may be terminated
by us at any time at our discretion without any penalty or cost to us.
Percentage
of Outstanding Shares After Giving Effect to the Purchased Shares Issued to Aspire Capital
In
connection with entering into the Purchase Agreement, we authorized the sale to Aspire Capital of up to $10.0 million of our shares
of common stock. However, we estimate that we will sell no more than 4,500,000 shares to Aspire Capital under the Purchase Agreement
(exclusive of the Commitment Shares), all of which are included in this offering. Subject to any required approval by our board
of directors, we have the right but not the obligation to issue more than the 4,500,000 shares included in this prospectus to
Aspire Capital under the Purchase Agreement. In the event we elect to issue more than 4,500,000 shares under the Purchase Agreement,
we will be required to file a new registration statement and have it declared effective by the SEC. The number of shares ultimately
offered for sale by Aspire Capital in this offering is dependent upon the number of shares purchased by Aspire Capital under the
Purchase Agreement. The following table sets forth the number and percentage of outstanding shares to be held by Aspire Capital
after giving effect to the sale of shares of common stock issued to Aspire Capital at varying purchase prices:
Assumed Average Purchase Price
|
|
|
Proceeds from the Sale of Shares to Aspire Capital Under the Purchase Agreement Registered in this Offering
|
|
|
Number of Shares to be Issued in this Offering at the Assumed Average Purchase Price (1)
|
|
|
Percentage of Outstanding Shares After Giving Effect to the Purchased Shares Issued to Aspire Capital (2)
|
|
$
|
1.43
|
|
|
$
|
6,292,000
|
|
|
|
4,400,000
|
|
|
|
19.9
|
%
|
$
|
1.50
|
|
|
$
|
6,600,000
|
|
|
|
4,400,000
|
|
|
|
19.9
|
%
|
$
|
2.00
|
|
|
$
|
8,800,000
|
|
|
|
4,400,000
|
|
|
|
19.9
|
%
|
$
|
2.27
|
|
|
$
|
10,000,000
|
|
|
|
4,400,000
|
|
|
|
19.9
|
%
|
(1)
|
Excludes
100,000 Commitment Shares issued under the Purchase Agreement between the Company and
Aspire Capital.
|
(2)
|
The
denominator is based on 22,755,818 shares outstanding as of October 28, 2019, which includes
the 100,000 shares previously issued to Aspire Capital and the number of shares set forth
in the adjacent column which we would have sold to Aspire Capital. The numerator is based
on the number of shares which we may issue to Aspire Capital under the Purchase Agreement
(that are the subject of this offering) at the corresponding assumed purchase price set
forth in the adjacent column.
|
USE
OF PROCEEDS
This
prospectus relates to shares of our common stock that may be offered and sold from time to time by Aspire Capital. We will not
receive any proceeds upon the sale of shares by Aspire Capital. However, we may receive proceeds of up to $10.0 million from the
sale of shares to Aspire Capital under the Purchase Agreement. The proceeds received from the sale of the shares under the Purchase
Agreement will be used for general corporate purposes, capital expenditures and working capital. This anticipated use of net proceeds
from the sale of our common stock to Aspire Capital under the Purchase Agreement represents our intentions based upon our current
plans and business conditions.
The
amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of
our development, the status of and results from clinical trials of our product candidates, our success in entering into strategic
partnerships for the development and commercialization of our product candidates, and any unforeseen cash needs. We may find it
necessary or advisable to use the net proceeds from this offering for other purposes, and our management will have broad discretion
in the application of the net proceeds.
Pending
the uses described above, we plan to invest the net proceeds from this offering in short-and intermediate-term, interest-bearing
obligations, investment-grade instruments, demand deposits, certificates of deposit or direct or guaranteed obligations of the
U.S. government.
DILUTION
The
sale of our common stock to Aspire Capital pursuant to the Purchase Agreement will have a dilutive impact on our stockholders.
As a result, our net income/(loss) per share would decrease/increase in future periods and the market price of our common stock
could decline. In addition, the lower our stock price is at the time we exercise our right to sell shares to Aspire Capital, the
more shares of our common stock we will have to issue to Aspire Capital pursuant to the Purchase Agreement and our existing stockholders
would experience greater dilution.
After
giving effect to the sale of 4,500,000 shares of our common stock (the number of shares registered in this offering) at an assumed
offering price of $1.43 per share (the closing price of our common stock on November 6, 2019), and after deducting
the estimated offering expenses payable by us, our as adjusted net tangible book value as of September 30, 2019 would have been
approximately $5.1 million, or approximately $0.19 per share of common stock. This amount represents an immediate increase in
as adjusted net tangible book value of $0.31 per share to our existing stockholders and an immediate dilution in as adjusted net
tangible book value of $1.56 per share to investors participating in this offering.
The
following table illustrates this dilution on a per share basis:
Assumed offering price per
share
|
|
|
|
|
|
$
|
1.43
|
|
Historical net tangible book value per share
as of September 30, 2019
|
|
$
|
(0.12
|
)
|
|
|
|
|
Increase
in net tangible book value per share attributable to investors in this offering
|
|
|
0.26
|
|
|
|
|
|
As adjusted net
tangible book value per share as of September 30, 2019 after this offering
|
|
|
|
|
|
|
0.14
|
|
Dilution
per share to investors participating in this offering
|
|
|
|
|
|
$
|
1.29
|
|
Each
$0.50 increase in the per share price at which we sell shares to Aspire Capital under the Purchase Agreement from the assumed
offering price of $1.43 per share would increase our as adjusted net tangible book value by $2.25 million, our as adjusted
net tangible book value per share by $0.09 and dilution per share to new investors purchasing shares of common stock in this offering
by $0.41, assuming that the number of shares of common stock offered, as set forth on the cover page of this prospectus, remains
the same and after deducting estimated aggregate offering expenses payable by us. This information is supplied for illustrative
purposes only.
The
table and calculations set forth above are based on the number of shares of common stock outstanding as of September 30, 2019
and assumes no exercise of any outstanding options or warrants. To the extent that options or warrants are exercised, there will
be further dilution to new investors.
Furthermore,
we may choose to raise additional capital through the sale of equity or debt securities due to market conditions or strategic
considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that any of
our options and warrants described above are exercised, new options are issued and exercised under our equity incentive plans
or we issue additional shares of common stock or other equity or convertible debt securities in the future, there will be further
dilution.
DESCRIPTION
OF CAPITAL STOCK
General
Our
authorized capital stock consists of 112,500,000 shares of common stock, $0.01 par value per share, and 100,000 shares of preferred
stock, $0.01 par value per share. As of October 28, 2019, there were 22,655,818 shares of our common stock outstanding (excluding
the Commitment Shares) and no shares of preferred stock outstanding.
The
following summary description of our capital stock is based on the applicable provisions of the Delaware General Corporation Law,
as amended (DGCL), the provisions of our certificate of incorporation, as amended (our certificate of incorporation), and our
bylaws, as amended (our bylaws). This information is qualified entirely by reference to the applicable provisions of the DGCL,
our certificate of incorporation and bylaws. For information on how to obtain copies of our certificate of incorporation and bylaws,
which are exhibits to the registration statement of which this prospectus is a part, see the section titled “Where You Can
Find Additional Information” in this prospectus.
Common
Stock
Holders
of common stock to be registered hereunder are entitled to one vote for each share held of record on all matters submitted to
a vote of stockholders and do not have cumulative voting rights. Subject to any preferential rights of any outstanding preferred
stock, holders of common stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by
our board of directors out of funds legally available therefor. In the event of a dissolution, liquidation or winding-up of the
Company, holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities and any preferential
rights of any outstanding preferred stock.
Holders
of common stock have no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund
provisions applicable to our common stock. All outstanding shares of common stock are fully paid and non-assessable. The rights,
preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the
holders of shares of any series of preferred stock which may be designated and issued in the future.
Preferred
Stock
Pursuant
to our certificate of incorporation, our board of directors has the authority, without further action by the stockholders (unless
such stockholder action is required by applicable law or NASDAQ rules), to designate and issue shares of preferred stock in one
or more series, to establish from time to time the number of shares to be included in each such series, to fix the designations,
powers (including voting), privileges, preferences and relative participating, optional or other rights, if any, of the shares
of each such series and the qualifications, limitations or restrictions thereof and to increase or decrease the number of shares
of any such series, but not below the number of shares of such series then outstanding.
We
will fix the designations, powers (including voting), privileges, preferences and relative participating, optional or other rights,
if any, of the preferred stock of each series, as well as the qualifications, limitations or restrictions thereof, in the certificate
of designation relating to that series. We will file as an exhibit to the registration statement of which this prospectus is a
part, or will incorporate by reference from reports that we file with the SEC, the form of any certificate of designation that
describes the terms of the series of preferred stock we are offering before the issuance of that series of preferred stock. This
description will include:
|
●
|
the
title and stated value;
|
|
|
|
|
●
|
the
number of shares we are offering;
|
|
|
|
|
●
|
the
liquidation preference per share;
|
|
●
|
the
purchase price;
|
|
|
|
|
●
|
the
dividend rate, period and payment date and method of calculation for dividends;
|
|
|
|
|
●
|
whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
|
|
|
●
|
the
procedures for any auction or remarketing, if any;
|
|
|
|
|
●
|
the
provisions for a sinking fund, if any;
|
|
|
|
|
●
|
the
provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and
repurchase rights;
|
|
|
|
|
●
|
any
listing of the preferred stock on any securities exchange or market;
|
|
|
|
|
●
|
whether
the preferred stock will be convertible into or exchangeable for other securities and, if applicable, the conversion price,
or how it will be calculated, and the conversion period;
|
|
|
|
|
●
|
voting
rights, if any, of the preferred stock;
|
|
|
|
|
●
|
preemptive
rights, if any;
|
|
|
|
|
●
|
restrictions
on transfer, sale or other assignment, if any;
|
|
|
|
|
●
|
liability
as to further calls or to assessment by the Company, if any;
|
|
|
|
|
●
|
a
discussion of any material United States federal income tax considerations applicable to the preferred stock;
|
|
|
|
|
●
|
the
relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind
up our affairs;
|
|
|
|
|
●
|
any
limitations on the issuance of any class or series of preferred stock ranking senior to or on a parity with the series of
preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and
|
|
|
|
|
●
|
any
other specific terms, preferences, rights or limitations of, or restrictions on, the
preferred stock.
|
The
DGCL provides that the holders of preferred stock will have the right to vote separately as a class or, in some cases, as a series
on an amendment to our certificate of incorporation if the amendment would change the par value or, unless our certificate of
incorporation provides otherwise, the number of authorized shares of the class or the powers, preferences or special rights of
the class or series so as to adversely affect the class or series, as the case may be. This right is in addition to any voting
rights that may be provided in the applicable certificate of designation.
Our
board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect
the voting power or other rights of the holders of our common stock or other securities. Preferred stock could be issued quickly
with terms designed to delay or prevent a change in control of our company or make removal of management more difficult. Additionally,
the issuance of preferred stock may have the effect of decreasing the market price of our common stock.
Anti-Takeover
Considerations and Special Provisions of Our Certificate of Incorporation, Our Bylaws and the Delaware General Corporation Law
Certificate
of Incorporation and Bylaws
A
number of provisions of our certificate of incorporation and bylaws concern matters of corporate governance and the rights of
our stockholders. Provisions that grant our board of directors the ability to issue shares of preferred stock and to set the voting
rights, preferences and other terms thereof may discourage takeover attempts that are not first approved by our board of directors,
including takeovers that may be considered by some stockholders to be in their best interests, such as those attempts that might
result in a premium over the market price for the shares held by stockholders. Certain provisions could delay or impede the removal
of incumbent directors even if such removal would be beneficial to our stockholders, such as the classification of our board of
directors and the lack of cumulative voting. Since our board of directors has the power to retain and discharge our officers,
these provisions could also make it more difficult for existing stockholders or another party to effect a change in management.
These
provisions may have the effect of deterring hostile takeovers or delaying changes in our control or in our management. These provisions
are intended to enhance the likelihood of continued stability in the composition of our board of directors and in the policies
they implement and to discourage certain types of transactions that may involve an actual or threatened change of our control.
These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal. The provisions also are intended
to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect of discouraging
others from making tender offers for our shares and, as a consequence, they also may inhibit fluctuations in the market price
of our shares that could result from actual or rumored takeover attempts.
These
provisions also could discourage or make more difficult a merger, tender offer or proxy contest, even if they could be favorable
to the interests of stockholders and could potentially depress the market price of our common stock. Our board of directors believes
that these provisions are appropriate to protect our interests and the interests of our stockholders.
Classification
of Board; No Cumulative Voting. Our certificate of incorporation and bylaws provide for our board of directors to be divided
into three classes, with staggered three-year terms. Only one class of directors is elected at each annual meeting of our stockholders,
with the other classes continuing for the remainder of their respective three-year terms. Because our stockholders do not have
cumulative voting rights, our stockholders representing a majority of the shares of common stock outstanding will be able to elect
all of our directors due to be elected at each annual meeting of our stockholders.
Meetings
of and Actions by Stockholders. Our bylaws provide that annual meetings of our stockholders may take place at the time and
place designated by our board of directors. A special meeting of our stockholders may be called at any time by our board of directors,
the chairman of our board of directors or the president. Our bylaws provide that (i) our board of directors can fix separate record
dates for determining stockholders entitled to receive notice of a stockholder meeting and for determining stockholders entitled
to vote at the meeting; (ii) we may hold a stockholder meeting by means of remote communications; (iii) any stockholder seeking
to have the stockholders authorize or take corporate action by written consent shall, by written notice to the secretary of the
Company, request that the board fix a record date and the board shall adopt a resolution fixing the record date in all events
within ten calendar days after a request is received; and (iv) a written consent of stockholders shall not be effective unless
a written consent signed by a sufficient number of stockholders to take such action is received by us within 60 calendar days
of the earliest dated written consent received.
Advance
Notice Requirements for Stockholder Proposals and Director Nominations. Our bylaws provide that stockholders seeking to bring
business before an annual meeting of stockholders or to nominate candidates for election as directors at an annual meeting of
stockholders must provide timely notice in writing. To be timely, a stockholder’s notice must be delivered to, or mailed
and received by, the secretary of the Company at our principal executive offices not later than the close of business on the 90th
calendar day, nor earlier than the close of business on the 120th calendar day in advance of the date specified in the Company’s
proxy statement released to stockholders in connection with the previous year’s annual meeting of stockholders. If the date
of the annual meeting is more than 30 calendar days before or after such anniversary date, notice by the stockholder to be timely
must be so not earlier than the close of business on the 120th calendar day in advance of such date of annual meeting and not
later than the close of business on the later of the 90th calendar day in advance of such date of annual meeting or the tenth
calendar day following the date on which public announcement of the date of the meeting is made. In no event shall the public
announcement of an adjournment or postponement of an annual meeting commence a new time period (or extend any time period) for
the giving of an advance notice by any stockholder.
Any
stockholder that proposes director nominations or other business must be a stockholder of record at the time the advance notice
is delivered by such stockholder to us and entitled to vote at the meeting. Our bylaws also specify requirements as to the form
and content of a stockholder’s notice. These provisions may preclude stockholders from bringing matters before an annual
meeting of stockholders or from making nominations for the election of directors at an annual meeting of stockholders. Unless
otherwise required by law, any director nomination or other business shall not be made or transacted if the stockholder (or a
qualified representative of the stockholder) does not appear at the meeting to present the director nominee or other proposed
business.
Filling
of Board Vacancies. Our certificate of incorporation and bylaws provide that the authorized size of our board of directors
shall be determined by the board by board resolution from time to time and that our board of directors has the exclusive power
to fill any vacancies and newly created directorships resulting from any increase in the authorized number of directors and the
stockholders do not have the power to fill such vacancies. Vacancies in our board of directors and newly created directorships
resulting from any increase in the authorized number of directors on our board of directors may be filled by a majority of the
directors remaining in office, even though that number may be less than a quorum of our board of directors, or by a sole remaining
director. A director so elected to fill a vacancy shall serve for the remaining term of the predecessor he or she replaced and
until his or her successor is elected and has qualified, or until his or her earlier resignation, removal or death.
Amendment
of the Certificate of Incorporation. Our certificate of incorporation may be amended, altered, changed or repealed at a meeting
of our stockholders entitled to vote thereon by the affirmative vote of a majority of the outstanding stock entitled to vote thereon
and a majority of the outstanding stock of each class entitled to vote thereon as a class, in the manner prescribed by the DGCL.
Amendment
of the Bylaws. Our bylaws may be amended or repealed, or new bylaws may be adopted, by either our board of directors or the
affirmative vote of at least 66 2/3 percent of the voting power of our outstanding shares of capital stock.
Section
203 of the Delaware General Corporation Law
We
are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in any business combination with
any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder,
with the following exceptions:
|
●
|
before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted
in the stockholder becoming an interested stockholder;
|
|
|
|
|
●
|
upon
completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder
owned at least 85 percent of the voting stock of the corporation outstanding at the time the transaction began, excluding
for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder)
those shares owned (i) by persons who are directors and also officers and (ii) pursuant to employee stock plans in which employee
participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in
a tender or exchange offer; and
|
|
|
|
|
●
|
on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special
meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3 percent of the outstanding
voting stock that is not owned by the interested stockholder.
|
In
general, Section 203 defines a business combination to include the following:
|
●
|
any
merger or consolidation involving the corporation and the interested stockholder;
|
|
|
|
|
●
|
any
sale, lease, transfer, pledge or other disposition of ten percent or more of the assets of the corporation to or with the
interested stockholder;
|
|
|
|
|
●
|
subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder;
|
|
●
|
any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class
or series of the corporation beneficially owned by the interested stockholder; and
|
|
|
|
|
●
|
the
receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits
by or through the corporation.
|
In
general, Section 203 of the DGCL defines an “interested stockholder” as an entity or person who, together with the
entity’s or person’s affiliates and associates, beneficially owns, or is an affiliate of the corporation and within
three years prior to the time of determination of interested stockholder status did own, 15 percent or more of the outstanding
voting stock of the corporation.
A
Delaware corporation may “opt out” of these provisions with an express provision in its certificate of incorporation.
We have not opted out of these provisions, which may as a result, discourage or prevent mergers or other takeover or change of
control attempts of us.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is American Stock Transfer & Trust Company, LLC (AST), located at 6201 15th
Avenue, Brooklyn, New York 11219. AST’s phone number is (800) 937-5449.
Nasdaq
Capital Market Listing
Our
common stock is listed on The Nasdaq Capital Market under the symbol “CLSN.”
Selling
Stockholder
The
selling stockholder may from time to time offer and sell any or all of the shares of our common stock set forth below pursuant
to this prospectus. When we refer to the “selling stockholder” in this prospectus, we mean the entity listed in the
table below, and its respective pledgees, donees, permitted transferees, assignees, successors and others who later come to hold
any of the selling stockholder’s interests in shares of our common stock other than through a public sale.
The
following table sets forth, as of the date of this prospectus, the name of the selling stockholder for whom we are registering
shares for sale to the public, the number of shares of common stock beneficially owned by the selling stockholder prior to this
offering, the total number of shares of common stock that the selling stockholder may offer pursuant to this prospectus and the
number of shares of common stock that the selling stockholder will beneficially own after this offering. Except as noted below,
the selling stockholder does not have, or within the past three years has not had, any material relationship with us or any of
our predecessors or affiliates and the selling stockholder is not or was not affiliated with registered broker-dealers.
Based
on the information provided to us by the selling stockholder, assuming that the selling stockholder sells all of the shares of
our common stock beneficially owned by it that have been registered by us and does not acquire any additional shares during the
offering, the selling stockholder will not own any shares other than those appearing in the column entitled “Beneficial
Ownership After This Offering.” We cannot advise you as to whether the selling stockholder will in fact sell any or all
of such shares of common stock. In addition, the selling stockholder may have sold, transferred or otherwise disposed of, or may
sell, transfer or otherwise dispose of, at any time and from time to time, the shares of our common stock in transactions exempt
from the registration requirements of the Securities Act of 1933 after the date on which it provided the information set forth
in the table below.
|
|
|
|
|
|
|
|
Beneficial
Ownership
After this Offering (1)
|
|
Name
|
|
Shares
of Common Stock Owned Prior to this Offering
|
|
|
Shares
of Common Stock Being Offered
|
|
|
Number
of
Shares
|
|
|
%(2)
|
|
Aspire
Capital Fund, LLC (3)
|
|
|
400,000
|
(4)
|
|
|
4,500,000
|
|
|
|
―
|
|
|
|
―
|
|
(1)
|
Assumes
the sale of all shares of common stock registered pursuant to this prospectus, although the selling stockholder is under no
obligation known to us to sell any shares of common stock at this time.
|
(2)
|
Based
on 22,655,818 shares of common stock outstanding on October 28, 2019 (which number excludes the Commitment Shares).
|
(3)
|
Aspire
Capital Partners LLC (“Aspire Partners”) is the Managing Member of Aspire Capital Fund LLC (“Aspire Fund”).
SGM Holdings Corp (“SGM”) is the Managing Member of Aspire Partners. Mr. Steven G. Martin (“Mr. Martin”)
is the president and sole shareholder of SGM, as well as a principal of Aspire Partners. Mr. Erik J. Brown (“Mr. Brown”)
is the president and sole shareholder of Red Cedar Capital Corp (“Red Cedar”), which is a principal of Aspire
Partners. Mr. Christos Komissopoulos (“Mr. Komissopoulos”) is president and sole shareholder of Chrisko Investors
Inc. (“Chrisko”), which is a principal of Aspire Partners. Mr. William F. Blank, III (“Mr. Blank”)
is president and sole shareholder of WML Ventures Corp. (“WML Ventures”), which is a principal of Aspire Partners.
Each of Aspire Partners, SGM, Red Cedar, Chrisko, WML Ventures, Mr. Martin, Mr. Brown, Mr. Komissopoulos and Mr. Blank may
be deemed to be a beneficial owner of common stock held by Aspire Fund. Each of Aspire Partners, SGM, Red Cedar, Chrisko,
WML Ventures, Mr. Martin, Mr. Brown, Mr. Komissopoulos and Mr. Blank disclaims beneficial ownership of the common stock held
by Aspire Fund.
|
(4)
|
Includes
(i) 300,000 shares of our common stock that were issued and sold to Aspire Capital pursuant to a purchase agreement entered
into between us and Aspire Capital in September 2018 and (ii) 100,000 shares of our common stock that have been issued to
Aspire Capital under the Purchase Agreement as a commitment fee. We may elect in our sole discretion to sell to Aspire Capital
up to an additional 4,400,000 shares under the Purchase Agreement but Aspire Capital does not presently beneficially own those
shares as determined in accordance with the rules of the SEC.
|
Plan
of Distribution
The
common stock offered by this prospectus is being offered by Aspire Capital, the selling stockholder. The common stock may be sold
or distributed from time to time by the selling stockholder directly to one or more purchasers or through brokers, dealers, or
underwriters who may act solely as agents at market prices prevailing at the time of sale, at prices related to the prevailing
market prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the common stock offered by this prospectus
may be effected in one or more of the following methods:
|
●
|
ordinary
brokers’ transactions;
|
|
|
|
|
●
|
transactions
involving cross or block trades;
|
|
|
|
|
●
|
through
brokers, dealers, or underwriters who may act solely as agents;
|
|
|
|
|
●
|
“at
the market” into an existing market for the common stock;
|
|
|
|
|
●
|
in
other ways not involving market makers or established business markets, including direct sales to purchasers or sales effected
through agents;
|
|
|
|
|
●
|
in
privately negotiated transactions; or
|
|
|
|
|
●
|
any
combination of the foregoing.
|
In
order to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed
brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for
sale in the state or an exemption from the registration or qualification requirement is available and complied with.
The
selling stockholder may transfer the shares of common stock by other means not described in this prospectus.
Brokers,
dealers, underwriters, or agents participating in the distribution of the shares as agents may receive compensation in the form
of commissions, discounts, or concessions from the selling stockholder and/or purchasers of the common stock for whom the broker-dealers
may act as agent. Aspire Capital has informed us that each such broker-dealer will receive commissions from Aspire Capital which
will not exceed customary brokerage commissions.
Aspire
Capital is an “underwriter” within the meaning of the Securities Act.
Neither
we nor Aspire Capital can presently estimate the amount of compensation that any agent will receive. We know of no existing arrangements
between Aspire Capital, any other stockholder, broker, dealer, underwriter, or agent relating to the sale or distribution of the
shares offered by this prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will
be distributed that will set forth the names of any agents, underwriters, or dealers and any compensation from the selling stockholder,
and any other required information.
We
will pay all of the expenses incident to the registration, offering, and sale of the shares to the public other than commissions
or discounts of underwriters, broker-dealers, or agents. We have agreed to indemnify Aspire Capital and certain other persons
against certain liabilities in connection with the offering of shares of common stock offered hereby, including liabilities arising
under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities.
Aspire Capital has agreed to indemnify us against liabilities under the Securities Act that may arise from certain written information
furnished to us by Aspire Capital specifically for use in this prospectus or, if such indemnity is unavailable, to contribute
amounts required to be paid in respect of such liabilities.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling
persons, we have been advised that in the opinion of the SEC this indemnification is against public policy as expressed in the
Securities Act and is therefore, unenforceable.
Aspire
Capital and its affiliates have agreed not to engage in any direct or indirect short selling or hedging of our common stock during
the term of the Purchase Agreement.
We
have advised Aspire Capital that while it is engaged in a distribution of the shares included in this prospectus it is required
to comply with Regulation M promulgated under the Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation
M precludes the selling stockholder, any affiliated purchasers, and any broker-dealer or other person who participates in the
distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the
subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made
in order to stabilize the price of a security in connection with the distribution of that security. All of the foregoing may affect
the marketability of the shares offered hereby this prospectus.
We
may suspend the sale of shares by Aspire Capital pursuant to this prospectus for certain periods of time for certain reasons,
including if the prospectus is required to be supplemented or amended to include additional material information.
This
offering will terminate on the date that all shares offered by this prospectus have been sold by Aspire Capital.
LEGAL
MATTERS
The
validity of the securities being offered hereby will be passed upon by Goodwin Procter LLP, Redwood City, California.
EXPERTS
WithumSmith+Brown,
PC (“Withum”), an independent registered public accounting firm, has audited our consolidated financial statements
included in our Annual Report on Form 10-K for the years ended December 31, 2018 and December 31, 2017, as set forth in their
report, which are incorporated by reference in this prospectus. Our financial statements are incorporated herein by reference
in reliance on Withum’s report, given on their authority as experts in accounting and auditing
WHERE
YOU CAN FIND MORE INFORMATION
We
file reports, proxy statements and other information with the SEC. The SEC maintains a web site that contains reports, proxy and
information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that
website is http://www.sec.gov.
Our
web site address is http://www.celsion.com. There we make available free of charge, on or through the investor relations
section of our website, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments
to those reports filed pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically
file such material with the SEC. The information on our web site, however, is not, and should not be deemed to be, a part of this
prospectus. All website addresses in this prospectus are intended to be inactive textual references only.
This
prospectus is part of a registration statement that we filed with the SEC and does not contain all of the information in the registration
statement. The full registration statement may be obtained from the SEC or us, as provided below. You may inspect a copy of the
registration statement through the SEC’s website, as provided above.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC’s rules allow us to “incorporate by reference” information into this prospectus, which means that we can
disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated
by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically
update and supersede that information. Any statement contained in a previously filed document incorporated by reference will be
deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus
modifies or replaces that statement.
We
incorporate by reference our documents listed below and any future filings we may make with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Securities Exchange Act of 1934, as amended, which we refer to as the “Exchange Act” in this prospectus
between the date of this prospectus and the termination of the offering of the securities described in this prospectus.
This
prospectus incorporates by reference the documents set forth below that have previously been filed with the SEC:
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●
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our
Annual Report on Form
10-K for the fiscal year ended December 31, 2018, filed with the SEC on March 29, 2019;
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|
|
●
|
our
Quarterly Reports on Form 10-Q for the fiscal quarter ended March 31, 2019, filed with the SEC on May 15, 2019, and
for the fiscal quarter ended June
30, 2019, filed with the SEC on August 14, 2019;
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|
|
|
|
●
|
the
portions of our definitive proxy statement on Schedule 14A filed with the SEC on March 29, 2019 that are deemed “filed”
with the SEC under the Exchange Act;
|
|
|
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|
●
|
our
Current Reports on Form 8-K filed with the SEC on March
14, 2019, April
1, 2019 and May
15, 2019; and
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|
|
|
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●
|
the
description of our common stock contained in our registration statement on Form 8-A filed with the SEC on May 26, 2000, as
amended by a Form 8-A/A dated February 7, 2008, and any amendments or reports filed for the purpose of updating such description.
|
All
reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of this offering, including any such filings made after the date of the initial registration statement and prior to
effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will
also be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of
such reports and documents.
Any
statement contained in this prospectus or in a document incorporated or deemed to be incorporated by reference into this prospectus
will be deemed to be modified or superseded for purposes hereof to the extent that a statement contained in this prospectus or
any other subsequently filed document that is deemed to be incorporated by reference into this prospectus modifies or supersedes
the statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute
a part of this prospectus.
You
may request a free copy of any of the documents incorporated by reference in this prospectus (other than exhibits, unless they
are specifically incorporated by reference in the documents) by writing or telephoning us at the following address:
Celsion,
Inc.
997
Lenox Drive, Suite 100
Lawrenceville,
NJ 08648
(609)
896-9100
Exhibits
to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distribution.
The
following table sets forth the expenses to be incurred in connection with the offering described in this registration statement,
all of which will be paid by the registrant. All amounts are estimates except for the SEC registration fee:
SEC registration
fee
|
|
$
|
836
|
|
Legal fees and expenses
|
|
|
25,000
|
|
Accounting fees and
expenses
|
|
|
5,000
|
|
Printing and related
expenses
|
|
|
1,000
|
|
Miscellaneous
|
|
|
500
|
|
Total
expenses
|
|
$
|
32,336
|
|
Item
14. Indemnification of Directors and Officers.
The
Company is incorporated under the laws of the State of Delaware. Our bylaws provide that we shall indemnify, to the maximum extent
and in the manner permitted by the Delaware General Corporation Law, as amended (DGCL), our current and former directors and officers,
and may indemnify our current and former employees and agents, against any and all expenses (including attorneys’ fees),
judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceeding arising from
their services in those capacities.
The
DGCL provides that a Delaware corporation has the power generally to indemnify its current and former directors, officers, employees
and other agents (each, a corporation agent) against expenses and liabilities, including amounts paid in settlement, in connection
with any proceeding involving such person by reason of his being a corporation agent, other than a proceeding by or in the right
of the corporation, if such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the best
interests of the corporation and, with respect to any criminal proceeding, such person had no reasonable cause to believe his
conduct was unlawful.
In
the case of an action brought by or in the right of the corporation, indemnification of a corporation agent is permitted if such
person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the
corporation. However, no indemnification is permitted in respect of any claim, issue or matter as to which such person shall have
been adjudged to be liable to the corporation, unless and only to the extent that the court in which such proceeding was brought
shall determine upon application that despite the adjudication of liability, but in view of all the circumstances of the case,
such person is fairly and reasonably entitled to such indemnification.
To
the extent that a corporation agent has been successful on the merits or otherwise in the defense of such proceeding, whether
or not by or in the right of the corporation, or in the defense of any claim, issue or matter therein, the corporation is required
to indemnify such person for expenses in connection therewith. Under the DGCL, the corporation may advance expenses incurred by
a corporation agent in connection with a proceeding, provided that the corporation agent undertakes to repay such amount if it
shall ultimately be determined that such person is not entitled to indemnification. Our certificate of incorporation requires
us to advance expenses to any person entitled to indemnification, provided that such person undertakes to repay the advancement
if it is determined in a final judicial decision from which there is no appeal that such person is not entitled to indemnification.
The
power to indemnify and advance the expenses under the DGCL does not exclude other rights to which a corporation agent may be entitled
to under our certificate of incorporation, by laws, agreement, vote of stockholders or disinterested directors or otherwise.
Our
certificate of incorporation permits us to secure insurance on behalf of our directors, officers, employees and agents for any
expense, liability or loss incurred in such capacities, whether or not the Company would have the power to indemnify such person
against such liability under the provisions of the DGCL.
The
purpose of these provisions is to assist us in retaining qualified individuals to serve as our directors, officers, employees
and agents by limiting their exposure to personal liability for serving as such.
Item
15. Recent Sales of Unregistered Securities.
On
October 28, 2019, we entered into the Purchase Agreement with Aspire Capital. Pursuant to the terms of the Purchase Agreement,
we issued 100,000 shares of our common stock to Aspire Capital in consideration for entering into the Purchase Agreement.
The
issuance of the Commitment Shares and all other shares of common stock that may be issued from time to time to Aspire Capital
under the Purchase Agreement is exempt from registration under the Securities Act, pursuant to the exemption for transactions
by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act.
Item
16. Exhibits and Financial Statement Schedules.
(a)
The exhibits set forth below have been or are being filed herewith and are numbered in accordance with Item 601 of Regulation
S-K.
(b)
Financial statement schedules have been omitted, as the information required to be set forth therein is included in the consolidated
financial statements or notes thereto incorporated by reference into the prospectus forming part of this registration statement.
EXHIBIT
NO.
|
|
DESCRIPTION
|
|
|
|
2.1
|
|
Asset Purchase Agreement dated as of June 6, 2014, by and between Celsion Corporation and EGEN, Inc., incorporated herein by reference to Exhibit 2.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2014.
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|
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2.2
|
|
Amendment to Asset Purchase Agreement between Celsion Corporation and EGWU, Inc., dated March 28, 2019 incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on April 1, 2019.
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|
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|
3.1
|
|
Certificate of Incorporation of Celsion, as amended, incorporated herein by reference to Exhibit 3.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2004.
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|
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3.2
|
|
Certificate of Ownership and Merger of Celsion Corporation (a Maryland Corporation) into Celsion (Delaware) Corporation (inter alia, changing the Company’s name to “Celsion Corporation” from “Celsion (Delaware) Corporation”), incorporated herein by reference to Exhibit 3.1.3 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2000.
|
3.3
|
|
Certificate of Amendment of the Certificate of Incorporation effective and filed on February 27, 2006, incorporated therein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on March 1, 2006.
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3.4
|
|
Certificate of Amendment to Certificate of Incorporation effective October 28, 2013, incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed on October 29, 2013.
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3.5
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|
Certificate of Amendment to Certificate of Incorporation effective June 15, 2016, incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company, filed on June 15, 2016.
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3.6
|
|
Certificate of Amendment to Certificate of Incorporation, effective May 26, 2017, incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company, filed on May 26, 2017.
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3.7
|
|
Amended and Restated By-laws dated November 27, 2011, incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company, filed on December 1, 2011.
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4.1
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|
Form of Common Stock Certificate, par value $0.01, incorporated herein by reference to Exhibit 4.1 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2000.
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4.2
|
|
Warrant to Purchase Stock, dated June 27, 2012, by and between Celsion Corporation and Oxford Finance LLC, incorporated herein by reference to Exhibit 4.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2012.
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|
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|
4.3
|
|
Warrant to Purchase Stock, dated June 27, 2012, by and between Celsion Corporation and Horizon Technology Finance Corporation, incorporated herein by reference to Exhibit 4.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2012.
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4.4
|
|
Form of Representative’s Common Stock Purchase Warrant, incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of the Company filed on October 31, 2017.
|
|
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|
4.5
|
|
Form of Placement Agent Common Stock Purchase Warrant incorporated herein by reference to Exhibit 4.4 to the Current Report on Form 8-K of the Company filed on July 11, 2017.
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4.6
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|
Registration Rights Agreement dated as of November 25, 2013, by and between Celsion Corporation and Hercules Technology Growth Capital, Inc., incorporated herein by reference to Exhibit 4.3 to the Registration Statement on Form S-3 (File No.: 333-193936) filed on February 13, 2014.
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|
4.7
|
|
Registration Rights Agreement dated as of June 20, 2014, by and between Celsion Corporation and Egen, Inc., incorporated herein by reference to Exhibit 4.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2014.
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|
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|
4.8
|
|
Form of Series AA Warrant, incorporated herein by reference to Exhibit 4.26 to the Registration Statement to the Registration Statement on Form S-1 of the Company filed on February 13, 2017.
|
|
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|
4.9
|
|
Form of Representative’s Common Stock Purchase Warrant, incorporated herein by reference to Exhibit 4.30 to the Registration Statement on Form S-1 of the Company filed on June 6, 2017.
|
|
|
|
4.10
|
|
Warrant to purchase Shares of Common Stock of Celsion Corporation between Celsion Corporation and EGWU, Inc., dated March 28, 2019.
|
|
|
|
4.11
|
|
Registration Rights Agreement, dated October 28, 2019, between Celsion Corporation and Aspire Capital Fund, LLC incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company filed on October 28, 2019.
|
5.1+
|
|
Opinion of Goodwin Procter LLP
|
|
|
|
10.1**
|
|
Celsion Corporation 2007 Stock Incentive Plan, as amended, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on May 16, 2017.
|
|
|
|
10.2**
|
|
Form of Stock Option Grant Agreement for Celsion Corporation 2004 Stock Incentive Plan, incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2006.
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|
|
|
10.3**
|
|
Form of Stock Option Grant Agreement for Celsion Corporation 2007 Stock Incentive Plan, incorporated herein by reference to Exhibit 10.1.6 to the Annual Report on Form 10-K of the Company for the year ended December 31, 2007.
|
|
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|
10.4**
|
|
Stock Option Agreement effective January 3, 2007, between Celsion Corporation and Michael H. Tardugno, incorporated herein by reference Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on January 3, 2007.
|
|
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|
10.5
|
|
Form Inducement Offer to Exercise Common Stock Purchase Warrants, incorporated herein by reference to exhibit 10.3 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2017.
|
|
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|
10.6
|
|
Form of Warrant Exercise Agreement, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 26, 2017.
|
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|
10.7
|
|
Form of Warrant Exercise Agreement, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 23, 2017.
|
|
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|
10.8
|
|
Form of Warrant Exercise Agreement, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 9, 2017.
|
|
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10.9**
|
|
Amended and Restated Employment Agreement, effective March 30, 2016, between Celsion Corporation and Mr. Michael H. Tardugno, incorporated by reference to Exhibit 10.8 to the Annual Report on Form 10-K of the Company filed on March 30, 2016.
|
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10.10**
|
|
Employment Offer Letter, entered into on June 15, 2010, between the Company and Jeffrey W. Church, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 18, 2010.
|
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10.11*
|
|
Patent License Agreement between the Company and Duke University dated November 10, 1999, incorporated herein by reference to Exhibit 10.9 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1999.
|
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|
10.12*
|
|
License Agreement dated July 18, 2003, between the Company and Duke University, incorporated herein by reference to Exhibit 10.1 to the Registration Statement on Form S-3 (File No. 333-108318) filed on August 28, 2003.
|
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|
10.13*
|
|
Development, Product Supply and Commercialization Agreement, effective December 5, 2008, by and between the Company and Yakult Honsha Co., Ltd., incorporated herein by reference to Exhibit 10.15 to the Annual Report on Form 10-K of the Company for the year ended December 31, 2008.
|
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10.14*
|
|
The 2nd Amendment To The Development, Product Supply And Commercialization Agreement, effective January 7, 2011, by and between the Company and Yakult Honsha Co., Ltd. incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on January 18, 2011.
|
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|
10.15
|
|
Lease Agreement, executed July 21, 2011, by and between Celsion Corporation and Brandywine Operating Partnership, L.P., incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on July 25, 2011.
|
10.16
|
|
First Amendment to Lease Agreement, executed April 20, 2017, by and between Celsion Corporation and Lenox Drive Office Park, LLC, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 10-Q of the Company filed on November 14, 2017.
|
|
|
|
10.17*
|
|
Technology Development Agreement effective as of May 7, 2012, by and between Celsion Corporation and Zhejiang Hisun Pharmaceutical Co. Ltd., incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2012.
|
|
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|
10.18
|
|
Loan and Security Agreement, dated June 27, 2012, by and among Celsion Corporation, Oxford Finance LLC, as collateral agent, and the lenders named therein, incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2012.
|
|
|
|
10.19
|
|
Controlled Equity OfferingSM Sales Agreement, dated February 1, 2013, by and between Celsion Corporation and Cantor Fitzgerald & Co., incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on February 1, 2013.
|
|
|
|
10.20
|
|
Securities Purchase Agreement, dated February 22, 2013, by and among Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on February 26, 2013.
|
|
|
|
10.21*
|
|
Technology Development Contract dated as of January 18, 2013, by and between Celsion Corporation and Zhejiang Hisun Pharmaceutical Co. Ltd., incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2013.
|
|
|
|
10.22
|
|
Loan and Security Agreement dated as of November 25, 2013, by and between Celsion Corporation and Hercules Technology Growth Capital, Inc., incorporated herein by reference to Exhibit 10.28 to the Annual Report on Form 10-K of the Company for the year ended December 31, 2013.
|
|
|
|
10.23
|
|
Securities Purchase Agreement dated as of January 15, 2014, by and between Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on January 21, 2014.
|
|
|
|
10.24**
|
|
Employment Offer Letter effective as of June 2, 2014, between the Company and Khursheed Anwer incorporated herein by reference to Exhibit 10.27 to the Annual Report on Form 10-K of the Company for the year ended December 31, 2014.
|
|
|
|
10.25
|
|
Securities Purchase Agreement dated as of May 27, 2015, by and among Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on May 29, 2015.
|
|
|
|
10.26
|
|
Securities Purchase Agreement dated as of June 13, 2016, by and among Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on June 17, 2016.
|
|
|
|
10.27**
|
|
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Michael H. Tardugno, incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016.
|
|
|
|
10.28**
|
|
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Nicholas Borys, M.D., incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016.
|
|
|
|
10.29**
|
|
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Jeffrey W. Church, incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016.
|
10.30**
|
|
Amended and Restated Change in Control Agreement dated as of September 6, 2016, by and between the Company and Timothy J. Tumminello, incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016.
|
|
|
|
10.31
|
|
Securities Purchase Agreement dated as of December 20, 2016, by and among Celsion Corporation and the purchasers named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed in December 23, 2016.
|
|
|
|
10.32
|
|
Form of Securities Purchase Agreement incorporated herein by reference to Exhibit 10.33 to the Registration Statement on Form S-1 of the Company filed on February 13, 2017.
|
|
|
|
10.33
|
|
Securities Purchase Agreement, dated July 6, 2017, by and among Celsion Corporation and the purchaser named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on July 11, 2017.
|
|
|
|
10.34
|
|
Securities Purchase Agreement, dated July 6, 2017, by and among Celsion Corporation and the purchaser named therein, incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on July 11, 2017.
|
|
|
|
10.35
|
|
Lease Agreement dated January 15, 2018, by and between Celsion Corporation and HudsonAlpha Institute of Biotechnology for office and lab space located in Huntsville, Alabama incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2018.
|
|
|
|
10.36
|
|
Venture Loan and Security Agreement dated June 27, 2018, by and between Celsion Corporation and Horizon Technology Finance Corporation incorporated herein by reference to Exhibit 10.0 to the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2018.
|
|
|
|
10.37
|
|
Capital on DemandTM Sales Agreement, dated December 4, 2018, between Celsion Corporation and JonesTrading Institutional Services LLC incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on December 4, 2018.
|
|
|
|
10.38
|
|
Second Amendment to Lease Agreement, dated January 9, 2019, by and between Celsion Corporation and Lenox Drive Office Park, LLC, successor in interest to Brandywine Operating Partnership, L.P.
|
|
|
|
10.39
|
|
Amendment to the Celsion Corporation 2018 Stock Incentive Plan incorporated by reference to the Current Report on Form 8K of the Company filed on May 15, 2019.
|
|
|
|
10.40
|
|
Common Stock Purchase Agreement, dated October 28, 2019 between Celsion Corporation and Aspire Capital Fund, LLC incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on October 28, 2019.
|
|
|
|
21.1
|
|
Subsidiaries of Celsion Corporation
|
|
|
|
23.1+
|
|
Consent of WithumSmith+Brown, PC, independent registered public accounting firm for the Company.
|
|
|
|
23.2+
|
|
Consent of Goodwin Procter LLP (included in Exhibit 5.1).
|
|
|
|
24.1+
|
|
Power of Attorney (included on signature page hereto)
|
|
|
|
*
|
|
Portions
of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, amended, and the omitted material has been separately filed with the Securities and Exchange Commission.
|
|
|
|
+
|
|
Filed
herewith.
|
|
|
|
**
|
|
Management
contract or compensatory plan or arrangement.
|
Item
17. Undertakings.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons
of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will
be governed by the final adjudication of such issue.
The
undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)
To include any prospectus required by Section 10(a)(3) of the Securities Act;
(ii)
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price
set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii)
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
(4)
That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule
424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or
other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement
as of the date it is first used after effectiveness; provided, however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into
the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract
of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that
was part of the registration statement or made in any such document immediately prior to such date of first use.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser,
if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i)
|
Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
|
|
|
(ii)
|
Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
|
|
|
(iii)
|
The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
|
|
|
(iv)
|
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
(6)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
SIGNATURES
Pursuant
to the requirements of the Securities Act, the Registrant has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Lawrenceville, State of New Jersey, on the 8th day of November,
2019.
|
CELSION CORPORATION
|
|
|
|
|
By:
|
/s/
MICHAEL H. TARDUGNO
|
|
|
Michael
H. Tardugno
|
|
|
Chairman
of the Board, President and Chief Executive Officer
|
POWER
OF ATTORNEY
KNOW
ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Michael H. Tardugno or Jeffrey
W. Church, and each of them, as his true and lawful attorneys-in-fact and agents, each with the full power of substitution and
resubstitution, for him and in his name, place or stead, in any and all capacities, to (i) act on, sign and file with the Securities
and Exchange Commission any and all amendments (including post-effective amendments) to this registration statement together with
all schedules and exhibits thereto and any subsequent registration statement filed pursuant to Rule 462(b) under the Securities
Act, together with all schedules and exhibits thereto, (ii) act on, sign and file such certificates, instruments, agreements and
other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any supplement to any prospectus
included in this registration statement or any such amendment or any subsequent registration statement filed pursuant to Rule
462(b) under the Securities Act, and (iv) take any and all actions which may be necessary or appropriate to be done, as fully
for all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact
and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities
and on the dates indicated.
Name
|
|
Position
|
|
Date
|
|
|
|
|
|
/s/
MICHAEL H. TARDUGNO
|
|
Chairman
of the Board, President and Chief Executive Officer
|
|
November
8, 2019
|
(Michael
H. Tardugno)
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
/s/
JEFFREY W. CHURCH
|
|
Executive
Vice President and Chief
|
|
November
8, 2019
|
(Jeffrey
W. Church)
|
|
Financial Officer
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/
TIMOTHY J. TUMMINELLO
|
|
Controller
and Chief Accounting Officer
|
|
November
8, 2019
|
(Timothy
J. Tumminello)
|
|
|
|
|
|
|
|
|
|
/s/
AUGUSTINE CHOW
|
|
Director
|
|
November
8, 2019
|
(Augustine
Chow, Ph.D.)
|
|
|
|
|
|
|
|
|
|
/s/
FREDERICK J. FRITZ
|
|
Director
|
|
November
8, 2019
|
(Frederick
J. Fritz)
|
|
|
|
|
|
|
|
|
|
/s/
ROBERT W. HOOPER
|
|
Director
|
|
November
8, 2019
|
(Robert
W. Hooper)
|
|
|
|
|
|
|
|
|
|
/s/
ALBERTO R. MARTINEZ
|
|
Director
|
|
November
8, 2019
|
(Alberto
Martinez, M.D.)
|
|
|
|
|
|
|
|
|
|
/s/
DONALD BRAUN
|
|
Director
|
|
November
8, 2019
|
(Donald
Braun, Ph.D.)
|
|
|
|
|
|
|
|
|
|
/s/
ANDREAS VOSS
|
|
Director
|
|
November
8, 2019
|
(Andreas
Voss, M.D.)
|
|
|
|
|
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