Celsion logo

CLSN - Celsion News Story

$1.37 -0.4  -21.3%

Last Trade - 22/01/21

Sector
Healthcare
Size
Micro Cap
Market Cap £37.5m
Enterprise Value £27.7m
Revenue £365k
Position in Universe 5289th / 6630

Celsion Corporation Reports Third Quarter 2020 Financial Results and Provides Business Update

Mon 16th November, 2020 1:30pm
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201116:nGNX3X6VwX


        Initiates Phase II OVATION 2 Study of GEN-1 in Advanced Ovarian
Cancer

Continues Following Patients for Overall Survival in Phase III OPTIMA Study 

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

LAWRENCEVILLE, N.J, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation
(https://www.globenewswire.com/Tracker?data=ReDZs1wmRZS5nBJPSJHwmubdNCOqWPhBCx2ydp-KTyg-YVKLNZHBBzLnUgK8natbX9jcallDBuIWIh2t7EiSFg==)
(NASDAQ: CLSN), an oncology drug development company, today announced
financial results for the three and nine months ended September 30, 2020, and
provided an update on clinical development programs with GEN-1, its
DNA-mediated IL-12 immunotherapy currently in Phase II development for the
treatment of advanced ovarian cancer, and ThermoDox(®), its proprietary
heat-activated liposomal encapsulation of doxorubicin currently in Phase III
development for the treatment of hepatocellular carcinoma (HCC), or primary
liver cancer.

“The OVATION 2 Study with our GEN-1 immunotherapy continues recruitment into
the 100 mg/m² dose cohort,” said Michael H. Tardugno, Celsion’s chairman,
president and chief executive officer. “This study is based on encouraging
results from our Phase Ib OVATION 1 Study in advanced ovarian cancer. In June
2020, the Data Safety Monitoring Board (DSMB) for the OVATION 2 Study
recommended that the Phase II portion proceed with the dose of 100 mg/m(2),
and in July 2020, we announced the randomization of the first two patients in
this portion of the Study. This milestone was achieved approximately five
months ahead of our previously announced schedule. We have a very aggressive
recruitment program in place and anticipate completing enrollment of
approximately 110 patients in the second or third quarter of 2021.
Importantly, as an open-label study, clinical updates will be provided
throughout the course of treatment, including response rates and surgical
resection scores,” Mr. Tardugno added.

Continuing his comments, Mr. Tardugno noted, “Since the DMC’s finding that
the OPTIMA Study crossed the futility boundary, albeit with substantial
uncertainty, and leaving the decision to terminate the Study up to the
Company, we have determined to continue following patients for overall
survival (OS) until such time as futility is either confirmed or dispelled.”

Mr. Tardugno added, “As promised, Celsion has engaged a global biometrics
contract research organization (CRO), with forensic statistical analysis
capability that specializes in data management, statistical consulting,
statistical analysis and data sciences. They have particular expertise in
evaluating unusual data from clinical trials, and experience with associated
regulatory issues. The primary objective of the CRO’s work is to determine
the basis and reasoning behind continuing to follow patients for OS. Also as
promised, and in parallel, the Company has submitted all OPTIMA Study clinical
trial data to the National Institutes of Health (NIH) for an independent
evaluation using a Cox Regression Analysis for minimum burn time per tumor
volume. This evaluation is similar to the hypothesis generated from the NIH
paper published in the Journal of Vascular and Interventional Radiology.”

In conclusion, Mr. Tardugno stated, “Celsion feels strongly that we owe it
to patients, physicians and our investors to continue examining the data from
the OPTIMA Study, particularly given how surprising the recommendation was to
Celsion from the DMC. While the trial outcome as predicted by the second
interim analysis may not change, and as unlikely as it may be, in the event we
see substantial clinical benefit from the CRO and NIH analyses, we will
carefully review our options with the 14 regulatory agencies under which the
OPTIMA Study is being conducted. We expect to report findings from these
independent analyses before the end of the year, either or both of which will
guide our decision to continue to follow patients to the final analysis at 197
or more deaths, a milestone we expect to be reached in mid-2021.”

Recent Developments

GEN-1 Immunotherapy

Initiation of Phase II OVATION 2 Study in Advanced Ovarian Cancer. In July
2020, the Company announced the randomization of the first two patients in the
Phase II portion of the OVATION 2 Study with GEN-1 in advanced ovarian cancer.
The Company anticipates completing enrollment of up to 118 patients in
mid-summer 2021. Because this is an open-label study, clinical updates will be
provided throughout the course of treatment including response rates and
surgical resection scores. The OVATION 2 Study combines GEN-1 with
standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed
with Stage III/IV ovarian cancer. NACT is designed to shrink the tumor as much
as possible for optimal surgical removal after three cycles of chemotherapy.
Following NACT, patients undergo interval debulking surgery, followed by three
adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1
treatments, the goal of which is to delay progression and improve OS. The
OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show
the equivalent of a 33% improvement in progression-free survival (PFS)
(HR=0.75), the primary endpoint, when comparing the treatment arm (standard of
care + GEN-1) with the control arm (standard of care alone).

ThermoDox(®)

Patients in Phase III OPTIMA Study Continue to be Followed for Overall
Survival. In August 2020, the Company provided an update on its ongoing review
of unblinded data from the second pre-planned interim analysis of the global
Phase III OPTIMA Study. The Company announced it will continue following
patients for OS, noting that the unexpected and marginally crossed futility
boundary suggested by the Kaplan-Meier analysis at the second interim analysis
on July 9, 2020 may be associated with a data maturity issue.

Recommendation from the Independent DMC to Consider Stopping the Phase III
OPTIMA Study of ThermoDox(®) in Primary Liver Cancer. In July 2020, the
Company announced that it received a recommendation from the independent DMC
to consider stopping the global Phase III OPTIMA Study. The recommendation was
made following the second pre-planned interim safety and efficacy analysis by
the DMC on July 9, 2020. The DMC analysis found that the pre-specified
boundary for stopping the trial for futility of 0.900 was crossed with an
actual value of 0.903. However, the p-value of 0.524 for this analysis
provides uncertainty. The DMC left the final decision of whether or not to
stop the OPTIMA Study to Celsion. There were no safety concerns noted during
the interim analysis.

The statistical plan for the OPTIMA Study included two interim efficacy
analyses by the DMC. The first interim analysis was announced in November 2019
following data lock in August 2019 after the prescribed minimum number of 128
patient events (deaths) was reached, and the second interim analysis was
conducted on July 9, 2020 following data lock in April 2020 after the
prescribed minimum number of 158 events was reached.

Corporate Developments

New Common Stock Purchase Agreement with Lincoln Park Capital. In September
2020, the Company announced a common stock purchase agreement for the issuance
and sale, from time to time, of up to $26 million of shares of common stock
with Lincoln Park Capital Fund, LLC (LPC). In connection with the execution of
the purchase agreement, LPC made an initial purchase of $1 million of common
stock at $1.00 per share, representing a significant premium to the
then-current market price. Under the terms of the new purchase agreement with
LPC, the Company has the right at its sole discretion, but not the obligation,
to sell to LPC up to $26 million worth of shares (including the $1 million
initially purchased) over the 36-month term of the agreement, subject to
certain conditions. There are no upper limits to the price per share LPC may
pay to purchase the shares, and the purchase price of the shares will be based
on the prevailing market prices at the time of each sale to LPC. Celsion
controls the timing and amount of any future sales of its stock to LPC. There
are no warrants, derivatives, financial or business covenants associated with
the agreement, and LPC has agreed not to cause or engage in any direct or
indirect short selling or hedging of Celsion’s common stock.

Strategic Loan Facility with Horizon Technology Finance Corporation
Restructured. In September 2020, the Company announced an amendment to its $10
million loan agreement with Horizon Technology Finance Corporation. Consistent
with its target to leverage equity capital, the Company elected to reduce its
outstanding debt under the loan by $5 million and restructure the terms of the
remaining $5 million loan balance. The Company’s restructured $5 million
loan is in the form of secured indebtedness bearing interest at a LIBOR-based
variable rate. Payments under the loan agreement are interest only for the
first 12 months through July 2021, followed by a 21-month amortization period
of principal and interest through the scheduled maturity date of April 2023.
In conjunction with the amended loan agreement, Celsion issued to Horizon
warrants exercisable for 247,525 shares of Celsion’s common stock at an
exercise price of $1.01 per share. Warrants previously issued to Horizon
exercisable for 95,057 shares at an exercise price of $2.63 per share were
cancelled.

Third Quarter Financial Results

For the quarter ended September 30, 2020, Celsion reported a net loss of $8.1
million ($0.24 per share), compared with $5.5 million ($0.25 per share) in the
same period of 2019.

Research and development expenses decreased $1.2 million to $2.5 million in
the third quarter of 2020, compared with $3.7 million in the third quarter of
2019. Clinical development costs for the Phase III OPTIMA Study decreased
$0.7 million to $0.5 million in the third quarter of 2020, compared with $1.2
million in the third quarter of 2019, due to the completion of enrollment in
this 556-patient trial in August 2018. Costs associated with the OVATION 2
Study were $0.2 million in each of the third quarters of 2020 and 2019. Other
costs related to clinical supplies and regulatory support for the
ThermoDox(®) and GEN-1 clinical development programs decreased to $1.3
million in the current quarter from $1.4 million in the third quarter of 2019,
largely driven by lower regulatory costs for ThermoDox®. General and
administrative expenses were $1.8 million in each of the third quarters of
2020 and 2019.

Operating expenses were $4.3 million in the third quarter of 2020, which
represented a $1.2 million (21.8%) decrease from $5.5 million in the same
period of 2019. These lower operating expenses were offset by the following
non-operating expenses: (i) a non-cash charge of $1.1 million for the change
in valuation of the earn-out milestone liability for the GEN-1 ovarian product
candidate; and (ii) a non-cash charge of $2.4 million related to the
impairment of certain in-process research and development assets related to
the development of the Company’s GBM cancer product candidate.

In connection with the Company’s venture debt facility with Horizon entered
in late June 2018, the Company repaid $5.0 million of the loan and
restructured the remaining $5.0 million for one-year interest only payments
and 21-month payback period thereafter. The Company incurred interest expense
of $0.5 million during the third quarter of 2020. This compares with interest
expense of $0.3 million in the comparable prior-year period.

The Company ended the third quarter of 2020 with $18.3 million in cash and
cash equivalents. Coupled with future planned sales of its New Jersey
NOL’s, the Company believes it has sufficient capital resources to fund its
operations through the end of 2021. The Company has based its estimates on
assumptions that may prove to be wrong and, accordingly, the Company may need
to obtain additional funds sooner or in greater amounts than is currently
anticipated.

Nine Month Financial Results

For the nine months ended September 30, 2020, the Company reported a net loss
of $18.5 million ($0.62 per share), compared with $13.7 million ($0.67 per
share) in the same period of 2019.

Research and development expenses decreased $1.5 million to $8.5 million in
the first nine months of 2020 from $10.0 million in the comparable prior year
period. Clinical development costs for the Phase III OPTIMA Study decreased by
$1.5 million to $1.8 million in the first nine months of 2020, compared with
$3.3 million in the first nine months of 2019, due to the completion of
enrollment in this 556-patient trial in August 2018. Costs associated with the
OVATION 2 Study increased to $0.7 million in the first nine months of 2020,
compared with $0.4 million in the comparable nine-month period in 2019. Other
costs related to ThermoDox(®) and GEN-1 clinical development programs
decreased by $0.2 million in the first nine months of 2020, compared with the
same prior-year period due to lower regulatory costs for the ThermoDox
development program.

General and administrative expenses were $5.5 million in the first nine months
of 2020, compared with $6.2 million in the same period of 2019. This 11%
decrease was primarily attributable to lower professional fees.

Operating expenses were $14.1 million during the first nine months of 2020,
which represented a $2.1 million (13%) decrease from $16.2 million in the same
period of 2019. These lower operating expenses in the first nine months of
2020 were offset by the following non-operating expenses: (i) a non-cash
charge of $1.4 million for the change in valuation of the earn-out milestone
liability for the GEN-1 ovarian product candidate, compared with a non-cash
gain of $2.7 million, net of charge of $0.4 million, for the 200,000 warrant
issuance related to an amendment for the potential milestone payments for the
GEN-1 ovarian product candidate during the comparable prior-year period; and,
(ii) a non-cash charge of $2.4 million related to the impairment of certain
in-process research and development assets related to the development of the
Company’s GBM cancer product candidate.

The Company realized $0.1 million of interest income during the first nine
months of 2020 and $0.4 million in the comparable prior-year period. The
Company incurred interest expense of $1.2 million and $1.0 million during the
first nine months of 2020 and 2019, respectively.

Net cash used for operating activities was $11.9 million in the first nine
months of 2020, compared with $16.2 million in the same period in 2019. This
was in line with the Company’s projected cash utilization for 2020 of
approximately $15.6 million, or an average of approximately $3.9 million per
quarter. Cash provided by financing activities was $15.4 million during the
first nine months of 2020 resulting from equity offerings in March 2020 and
June 2020, and proceeds from (i) the sale of equity from its ATM facility with
Jones Trading, (ii) the sale of equity from its Common Stock Purchase
Agreement with Lincoln Park Capital, including a $1 million sale at 22%
premium to market in September 2020, and (iii) the exercise of stock options.

Third Quarter Conference Call

The Company will host a conference call to provide a business update and
discuss third quarter 2020 financial results at 11:00 a.m. EST today. To
participate in the call, interested parties may dial 1-800-367-2403
(Toll-Free/North America) or 1-334-777-6978 (International/Toll) 10 minutes
before the call is scheduled to begin, and ask for the Celsion Corporation
Third Quarter 2020 Earnings Call (Conference Code: 8337630). The call will
also be broadcast live on the internet at www.celsion.com.

The call will be archived for replay on November 16, 2020 and will remain
available until November 30, 2020. The replay can be accessed at
1-719-457-0820 or 1-888-203-1112 using Conference ID: 8337630. An audio replay
of the call will also be available on the Company's website, www.celsion.com,
for 90 days after 2:00 p.m. EST on November 16, 2020.

About Celsion Corporation

Celsion is a fully integrated oncology company focused on developing a
portfolio of innovative cancer treatments, including immunotherapies,
DNA-based therapies and directed chemotherapies. The Company’s product
pipeline includes GEN-1, a DNA-based immunotherapy for the localized treatment
of ovarian cancer and ThermoDox(®), a proprietary heat-activated liposomal
encapsulation of doxorubicin, currently in Phase III development for the
treatment of primary liver cancer and in development for other cancer
indications. Celsion has two feasibility stage platform technologies for the
development of novel nucleic acid-based immunotherapies and other anti-cancer
DNA or RNA therapies. Both are novel synthetic, non-viral vectors with
demonstrated capability in nucleic acid cellular transfection. For more
information on Celsion, visit: http://www.celsion.com. (CLSN-FIN).

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

Celsion Investor Contact

Jeffrey W. Church
609-482-2455
 jchurch@celsion.com

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com



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

                                                                                                          Three Months Ended September 30,                     Nine Months Ended September 30,                      
                                                                                                          2020                            2019                 2020                             2019                
                                                                                                                                                                                                                    
 Licensing revenue                                                                                        $       125                     $       125          $       375                      $       375         
                                                                                                                                                                                                                    
 Operating expenses:                                                                                                                                                                                                
 Research and development                                                                                         2,492                           3,674                8,535                            10,000      
 General and administrative                                                                                       1,793                           1,839                5,533                            6,193       
 Total operating expenses                                                                                         4,285                           5,513                14,068                           16,193      
                                                                                                                                                                                                                    
 Loss from operations                                                                                             (4,160  )                       (5,388  )            (13,693  )                       (15,818  )  
                                                                                                                                                                                                                    
 Other income (expense):                                                                                                                                                                                            
 (Loss) gain from change in valuation of earn-out milestone liability                                             (1,100  )                       86                   (1,397   )                       3,089       
 Loss from impairment of in-process research and development                                                      (2,370  )                       –                    (2,370   )                       –           
 Fair value of warrants issued in connection with amendment to modify GEN-1 earn-out milestone payment            –                               –                    –                                (400     )  
 Interest expense, investment income and other income (expense), net                                              (442    )                       (175    )            (1,011   )                       (620     )  
 Total other income (expense), net                                                                                (3,912  )                       (89     )            (4,778   )                       2,069       
                                                                                                                                                                                                                    
                                                                                                                                                                                                                    
 Net loss                                                                                                 $       (8,072  )               $       (5,477  )    $       (18,471  )               $       (13,749  )  
                                                                                                                                                                                                                    
 Net loss per common share                                                                                                                                                                                          
 Basic and diluted                                                                                        $       (0.24   )               $       (0.25   )    $       (0.62    )               $       (0.67    )  
                                                                                                                                                                                                                    
 Weighted average shares outstanding                                                                                                                                                                                
 Basic and diluted                                                                                                34,112                          21,663               29,935                           20,525      
                                                                                                                                                                                                                    



Celsion Corporation
Selected Balance Sheet Information
(in thousands)

 ASSETS                                                                    September 30, 2020 (Unaudited)           December 31, 2019        
 Current assets                                                                                                                              
 Cash and cash equivalents                                                 $                 18,340                 $          6,875         
 Investment securities and interest receivable on investment securities                      –                                 8,007         
 Advances, deposits on clinical programs and other current assets                            1,566                             1,353         
 Total current assets                                                                        19,906                            16,235        
                                                                                                                                             
 Property and equipment                                                                      302                               405           
                                                                                                                                             
 Other assets                                                                                                                                
 Deferred tax asset                                                                          -                                 1,820         
 In-process research and development                                                         13,366                            15,736        
 Goodwill                                                                                    1,976                             1,976         
 Operating lease right-of-use assets, net                                                    1,147                             1,432         
 Other intangible assets, deposits and other assets                                          578                               674           
 Total other assets                                                                          17,067                            21,638        
 Total assets                                                              $                 37,275                 $          38,278        
                                                                                                                                             
 LIABILITIES AND STOCKHOLDERS’ EQUITY                                                                                                        
 Current liabilities                                                                                                                         
 Accounts payable and accrued liabilities                                  $                 4,088                  $          5,166         
 Notes payable – current portion                                                             416                               1,840         
 Operating lease liability – current portion                                                 422                               388           
 Deferred revenue - current portion                                                          500                               500           
 Total current liabilities                                                                   5,426                             7,894         
                                                                                                                                             
 Earn-out milestone liability                                                                7,115                             5,718         
 Notes payable                                                                               4,627                             7,963         
 Operating lease liability                                                                   823                               1,144         
 Deferred revenue and other liabilities                                                      625                               1,000         
 Total liabilities                                                                           18,616                            23,719        
 Stockholders’ equity                                                                                                                        
 Common stock                                                                                362                               232           
 Additional paid-in capital                                                                  327,370                           304,886       
 Accumulated other comprehensive gain (loss)                                                 –                                 43            
 Accumulated deficit                                                                         (308,988          )               (290,517   )  
                                                                                             18,744                            14,644        
 Less: Treasury stock                                                                        (85               )               (85        )  
 Total stockholders’ equity                                                                  18,659                            14,559        
 Total liabilities and stockholders’ equity                                $                 37,275                 $          38,278        







(https://www.globenewswire.com/NewsRoom/AttachmentNg/38ec2900-8f4f-40ac-9807-64be276aa13e)



GlobeNewswire, Inc. 2020
© Stockopedia 2021, Refinitiv, Share Data Services.
This site cannot substitute for professional investment advice or independent factual verification. To use it, you must accept our Terms of Use, Privacy and Disclaimer policies.