Celsion Corporation (NASDAQ: CLSN), an oncology drug development
company, today announced financial results for the three months
ended March 31, 2020, and provided an update on clinical
development programs with ThermoDox®, its proprietary
heat-activated liposomal encapsulation of doxorubicin currently in
Phase III development for the treatment of hepatocellular carcinoma
(HCC), or primary liver cancer, and GEN-1, its DNA-mediated IL-12
immunotherapy, currently in Phase I/II development for the
treatment of advanced stage ovarian cancer.
“During the first quarter and recent weeks,
Celsion continued to make substantial progress with our ongoing
development programs with ThermoDox® and GEN-1, while maintaining a
strong balance sheet,” said Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. “With our pivotal
556-patient Phase III OPTIMA Study in HCC fully enrolled, we now
look forward to the preplanned interim efficacy analysis in July
2020.”
“Our GEN-1 immunotherapy product continued to
show encouraging results at the 100 mg/m² dose cohort in the
OVATION 2 Study, which is consistent with the results reported from
our earlier Phase Ib trial (the OVATION 1 Study) in advanced stage
ovarian cancer. These findings were reinforced by strong
progression-free survival when comparing study patients to a
statistically validated synthetic control arm of matched patients
from prior studies. This unique means of evaluating efficacy holds
great potential for clinical research, and we plan to use it in
upcoming discussions with the U.S. Food and Drug Administration as
part of our goal to accelerate GEN-1 clinical development. In
addition, GEN-1 received Orphan Drug Designation from the European
Medicines Agency in April 2020.” Mr. Tardugno added, “Our
fundamentals are strong, and we are well positioned with a capital
structure sufficient to see our clinical programs through
transformative milestones in 2020.”
Recent Developments
ThermoDox®
Sufficient Number of Patient Deaths Were
Reached for the Second Interim Analysis of the Phase III OPTIMA
Study of ThermoDox® in Primary Liver Cancer. In April 2020
the Company announced that the prescribed minimum number of events
(158 patient deaths) was reached for the second pre-specified
interim analysis of the OPTIMA Phase III Study with ThermoDox® plus
RFA (radiofrequency ablation) in patients with HCC. Following
preparation of the data, the Independent Data Monitoring Committee
(iDMC) is expected to meet in July to conduct the second interim
analysis. Celsion expects to announce iDMC recommendations as soon
as possible after the meeting. The hazard ratio (HR) and p-value
necessary for success at 158 deaths are 0.70 and 0.022,
respectively, which compare favorably with the hazard ratio and
p-value observed in the prospective HEAT Study subgroup upon which
the OPTIMA Study is based.
The OPTIMA Study was fully enrolled in August
2018 with 556 subjects from 65 clinical sites in 14 countries. The
study design is based on the Company’s HEAT Study, in which a
prospective subgroup analysis of 285 subjects with a single lesion
of 3-7 cm in size received a single ThermoDox® administration in
combination with a 45 minute or longer RFA procedure. Followed
prospectively for 3 years, those patients demonstrated a median
survival of more than 7 ½ years and a survival benefit of more than
2 years over the control group. These data were published in the
October 2017 issue of the peer-reviewed journal Clinical Cancer
Research, and are available here.
GEN-1 Immunotherapy
GEN-1 Showed Strong Progression-Free
Survival Treatment Effect Utilizing Medidata’s Synthetic Control
Arm. In March 2020 the Company announced that
Medidata-matched patient data from a synthetic control arm (SCA)
compared with results from the Company’s completed Phase Ib
dose-escalating OVATION 1 Study with GEN-1 in Stage III/IV ovarian
cancer patients showed positive results in progression-free
survival (PFS). The HR was 0.53 in the intent-to-treat group,
showing strong signals of efficacy. Medidata is a globally
recognized leader in clinical data management.
Celsion believes these data may warrant
consideration of strategies to accelerate the clinical development
for GEN-1 in newly diagnosed, advanced ovarian cancer patients by
the U.S. Food and Drug Administration (FDA). In its March 2019
discussion with Celsion, the FDA noted that preliminary findings
from the Phase Ib OVATION 1 Study were exciting but lacked a
control group to evaluate GEN-1’s independent impact on impressive
tumor response, surgical results and PFS. The FDA encouraged
Celsion to continue its GEN-1 development program and consult with
FDA with new findings that may have a bearing on designations such
as Fast Track and Breakthrough Therapy.
GEN-1’s strong and encouraging treatment effect,
evidenced by the synthetic control arm, suggests a potentially
remarkable improvement in PFS, an FDA-recognized surrogate for
overall survival, and appears to confirm the science behind IL-12’s
ability to recruit the innate and adaptive elements of the immune
system to fight malignancies. The strong PFS trend is supported by
previously published translational data that clearly demonstrate
the pro-immune changes in the tumor micro-environment associated
with loco-regional GEN-1 therapy. Celsion’s randomized Phase II
OVATION 2 Study in advanced ovarian cancer patients is expected to
commence in the fourth quarter of 2020 and is designed to
demonstrate a 33% improvement in PFS (HR = 0.75) over current
standard of care. PFS is the primary endpoint for this study.
SCAs have the potential to revolutionize
clinical trials in certain oncology indications and some other
diseases where a randomized control is not ethical or practical.
SCAs are formed by carefully selecting control patients from
historical clinical trials to match the demographic and disease
characteristics of the patients treated with the new
investigational product. SCAs have been shown to mimic the results
of traditional randomized controls so that the treatment effects of
an investigational product can be visible by comparison to the SCA.
SCAs can help advance the scientific validity of single-arm trials,
and in certain indications, reduce time and cost, and expose fewer
patients to placebos or existing standard-of-care treatments that
might not be effective for them. Medidata is in a unique position
to create fit-for-purpose synthetic controls because of access to a
pool of more than six million anonymized patients from nearly
20,000 previous clinical trials.
PFS data generated from this analysis comparing
GEN-1 with SCA showed the following:
GEN-1 Population |
PFS Hazard Ratio (Confidence Interval) |
Intent-to-treat, n=15 |
0.53 (95% CI 0.16, 1.73); log-rank p=0.29 |
Per-protocol, n=14 |
0.33 (95% CI 0.08, 1.37); log-rank p=0.11 |
Highly Encouraging Initial Clinical
Results from the Phase I Portion of the Phase I/II OVATION 2 Study
with GEN-1 in Patients with Advanced Ovarian Cancer. In
March 2020 the Company announced highly encouraging initial
clinical data from the first 15 patients enrolled in the ongoing
Phase I/II OVATION 2 Study for patients newly diagnosed with Stage
III and IV ovarian cancer. The OVATION 2 Study combines GEN-1, the
Company's IL-12 gene-mediated immunotherapy, with standard-of-care
neoadjuvant chemotherapy (NACT). Following NACT, patients undergo
interval debulking surgery (IDS), followed by three additional
cycles of chemotherapy.
GEN-1 plus standard NACT produced positive
dose-dependent efficacy results, with no dose-limiting toxicities,
which correlates well with successful surgical outcomes as
summarized below:
- Of the 15 patients treated in the
Phase I portion of the OVATION 2 Study, nine were treated with
GEN-1 at a dose of 100 mg/m² plus NACT and six were treated with
NACT only. All 15 had successful resections of their tumors, with
seven out of nine patients (78%) in the GEN-1 treatment arm having
an R0 resection, which indicates a microscopically margin-negative
resection in which no gross or microscopic tumor remains in the
tumor bed. Only three out of six patients (50%) in the NACT only
treatment arm had an R0 resection.
- When combining these results with
the surgical resection rates observed in the Company’s prior Phase
Ib dose-escalation trial (the OVATION 1 Study), a population of
patients with inclusion criteria identical to the OVATION 2 Study,
the data reflect the strong dose-dependent efficacy of adding GEN-1
to the current standard of care NACT:
|
|
% of Patients with |
|
|
R0 Resections |
|
|
|
0, 36, 47 mg/m² of GEN-1 plus
NACT |
n=12 |
42% |
61, 79, 100 mg/m² of GEN-1 plus
NACT |
n=17 |
82% |
- The objective response rate (ORR) as measured by Response
Evaluation Criteria in Solid Tumors (RECIST) criteria for the 0,
36, 47 mg/m² dose GEN-1 patients were comparable, as expected, to
the higher (61, 79, 100 mg/m²) dose GEN-1 patients, with both
groups demonstrating an approximate 80% ORR.
GEN-1 Received Orphan Drug Designation
from the European Medicines Agency. In
March 2020 the Company announced the European Medicines Agency
(EMA) Committee for Orphan Medicinal Products recommended that
GEN-1 be designated as an orphan medicinal product for the
treatment of ovarian cancer. As established by the EMA, this
designation provides for scientific advice and certain regulatory
assistance during the product development phase, direct access to
centralized marketing authorization and certain financial
incentives for companies developing new therapies intended for the
treatment of a life-threatening or chronically debilitating
condition that affects no more than five in 10,000 people in the
European Union (EU).
Benefits of the designation include:
- 10 years of market exclusivity (in which other industry
sponsors are prevented from entering the market with a similar
product for the same therapeutic indication);
- EMA protocol assistance for sponsors on the conduct of the
tests and trials necessary to demonstrate their quality, safety and
efficacy, or regulatory assistance;
- EMA advice will be free or given in return for reduced
fees;
- Access to a centralized procedure allowing immediate marketing
authorization in all Member States and facilitating the
availability of medicines to all patients in the EU;
- Eligibility for a reduction of regulatory fees associated with
pre-authorization inspections, as well as marketing authorization
application fees and certain other fees for qualifying
companies.
GEN-1 previously received orphan drug
designation from the FDA.
Corporate Developments
Received $1.8 Million in Non-Dilutive
Funding from the Sale of Its New Jersey State Net Operating
Losses. In April 2020 the Company announced it received
$1.82 million of net cash proceeds from the sale of approximately
$1.9 million of its unused New Jersey net operating losses (NOLs).
The NOL sales cover the tax years 2017 and 2018 and are
administered through the New Jersey Economic Development
Authority’s (NJEDA) Technology Business Tax Certificate Transfer
(NOL) Program. With this new non-dilutive funding, coupled with the
$4.4 million in net proceeds from the recent registered direct
equity offer completed on March 3, 2020, the Company strengthened
its balance sheet at a time of capital markets uncertainty. An
additional sale of $2.0 million of unused New Jersey NOLs
anticipated in the second half of 2020 will further increase
Celsion’s cash reserves on a non-dilutive basis. In addition, the
Company initiated several cost containment measures to ensure that
it has sufficient cash to fund operations and clinical development
programs through the second quarter of 2021, which includes all
major Phase III OPTIMA Study readouts.
On April 21, 2020, we entered into a loan
agreement with Silicon Valley Bank (the “PPP Loan”), pursuant to
the Paycheck Protection Program of the Coronavirus Aid, Relief, and
Economic Security Act. We thereafter received proceeds of $632,220
under the PPP Loan. The PPP Loan application required Celsion to
certify that there was economic uncertainty surrounding the Company
and that, as such, the PPP Loan was necessary to support our
ongoing operations. Celsion made this certification in good faith
after analyzing, among other things, its financial situation and
access to alternative forms of capital, and believes that the
Company satisfied all eligibility criteria for the PPP Loan, and
that our receipt of the PPP Loan proceeds was consistent with the
broad objectives of the PPP of the CARES Act. The certification
given with respect to the PPP Loan does not contain any objective
criteria and is subject to interpretation. In light of subsequent
guidance issued by the U.S. Small Business Administration in
consultation with the U.S. Department of the Treasury, out of an
abundance of caution, we returned the proceeds of the PPP Loan in
full on May 13, 2020. Celsion may choose to reapply for the loan if
the SBA provides future applicable guidance.
Strengthened Balance Sheet Through a
$4.8 Million Registered Direct Offering. In February 2020 the Company entered
into securities purchase agreements with several institutional
investors for the purchase and sale of 4,571,428 shares of the
Company’s common stock pursuant to a registered direct offering.
Celsion also agreed to issue to such investors, in a concurrent
private placement, warrants to purchase approximately 3.2 million
shares of the Company’s common stock. The warrants are exercisable
on the six-month anniversary of the issuance date, will expire on
the five-year anniversary of the initial exercise date and have an
exercise price of $1.24 per share. Gross proceeds of the offering
were $4.8 million before deducting placement agent fees and other
estimated offering expenses.
First Quarter Financial
Results
Celsion reported a net loss for the first
quarter of 2020 of $5.1 million ($0.20 per share) compared with a
net loss of $2.4 million ($0.12 per share) for the first quarter of
2019. Operating expenses were $4.9 million for the first quarter of
2020, which represented a $0.1 million (2%) decrease from $5.0
million in the same period of 2019. During the first quarter of
2020, the Company incurred $0.5 million in non-cash stock option
expense compared with $0.7 million in the comparable prior-year
period.
Cash, cash equivalents, short-term investments,
interest receivable and receivable on sale of deferred tax asset as
of March 31, 2020 was $17.5 million. In the second quarter of 2020,
the Company received $1.8 million in net proceeds from the sale of
its New Jersey net operating losses. The Company has approximately
$2.0 million in future tax benefits remaining under the NJEDA
Technology Business Tax Certificate Transfer program for future
years. Cash provided by financing activities was $5.8 million and
net cash used for operating activities was $5.0 million for the
first quarter of 2020, compared with $5.5 million for the
comparable prior-year period.
Research and development costs for the first
quarter of 2020 were $3.1 million compared with $2.8 million for
the first quarter of 2019. Clinical development costs for the Phase
III OPTIMA Study were $0.7 million for the first quarter of 2020
compared with $0.9 million for the same period of 2019. These costs
have decreased as the trial has moved into the follow-up phase
after full patient enrollment in August 2018. Costs associated with
the OVATION 2 Study increased to $0.3 million for the first quarter
of 2020 compared with $0.1 million for the same period in 2019. The
Company announced the initiation of the follow-on Phase I/II
OVATION 2 Study in September 2018 with full enrollment of the Phase
I portion of the trial completed in the first half of 2020. Costs
associated with Celsion’s wholly-owned subsidiary CLSN
Laboratories, Inc. (which includes research and development
activities for GEN-1, TheraPlas and TheraSilence) increased to $0.9
million in the first quarter of 2020 compared with $0.6 million in
the first quarter of 2019 as the Company continued to expand its
manufacturing capabilities and implemented programs to reduce
manufacturing costs for GEN-1.
General and administrative expenses were $1.8
million for the first quarter of 2020 compared with $2.2 million
for the first quarter of 2019. The $0.4 million decrease was
primarily attributable to a decrease in personnel costs and lower
compensation expenses related to non-cash stock option compensation
expense, partially offset by an increase in premiums for directors’
and officers’ insurance for 2020.
Other expenses during the first quarter of 2020
included a non-cash charge of $41,000 for the change in valuation
of the earn-out milestone liability for the GEN-1 ovarian product
candidate compared with a non-cash gain of $2.7 million, net of
charge of $0.4 million for the 200,000 warrant issuance related to
an amendment for the potential milestone payments for the GEN-1
ovarian product candidate during the first quarter of 2019. The
Company realized $0.1 million of interest income from its
short-term investments during both the first quarter of 2020 and
2019. In connection with the Company’s new venture debt facility
with Horizon in June 2018, the Company incurred interest expense of
$0.3 million during both the first quarter of 2020 and 2019.
First Quarter Conference
Call
The Company will host a conference call to
provide a business update and discuss its first quarter 2020
financial results at 11:00 a.m. EDT today. To participate in the
call, interested parties may dial 1-800-367-2403 (Toll-Free/North
America) or 1-334-777-6978 (International/Toll) 10 minutes before
the call is scheduled to begin, and ask for the Celsion Corporation
First Quarter 2020 Earnings Call (Conference Code: 6901311). The
call will also be broadcast live on the internet at
www.celsion.com. The call will be archived for replay through May
29, 2020. The replay can be accessed at 1-719-457-0820 or
1-888-203-1112 using Conference ID: 6901311. An audio replay of the
call will also be available on the Company's website,
www.celsion.com, for 90 days after 2:00 p.m. EDT Friday, May 15,
2020.
About Celsion Corporation
Celsion is a fully integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company's lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
Celsion has two platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. For more information on Celsion, visit our website:
http://www.celsion.com (CLSN-FIN).
Celsion wishes to inform readers that
forward-looking statements in this release are made pursuant to the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, unforeseen changes in the course of research and
development activities and in clinical trials; the uncertainties of
and difficulties in analyzing interim clinical data; the
significant expense, time, and risk of failure of conducting
clinical trials; the need for Celsion to evaluate its future
development plans; possible acquisitions or licenses of other
technologies, assets or businesses; possible actions by customers,
suppliers, competitors, regulatory authorities; and other risks
detailed from time to time in Celsion's periodic reports and
prospectuses filed with the Securities and Exchange Commission.
Celsion assumes no obligation to update or supplement
forward-looking statements that become untrue because of subsequent
events, new information or otherwise.
Celsion Investor Contact
Jeffrey W. Church609-482-2455
jchurch@celsion.com
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
Celsion Corporation |
Condensed Statements of Operations |
(in thousands except per share amounts) |
(unaudited) |
|
|
Three Months Ended March
31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
Licensing
revenue |
|
$ |
125 |
|
|
$ |
125 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,052 |
|
|
|
2,768 |
|
General and administrative |
|
|
1,839 |
|
|
|
2,218 |
|
Total operating expenses |
|
|
4,891 |
|
|
|
4,986 |
|
Loss from
operations |
|
|
(4,766 |
) |
|
|
(4,861 |
) |
|
|
|
|
|
|
|
|
|
Other (expense)
income: |
|
|
|
|
|
|
|
|
Gain (loss) from valuation of earn-out milestone liability |
|
|
(41 |
) |
|
|
3,130 |
|
Fair value of warrants issued in connection with amendment to
modify earn-out milestone payments |
|
|
- |
|
|
|
(400 |
) |
Investment income, interest (expense) and other income (expense),
net |
|
|
(250 |
) |
|
|
(236 |
) |
Total other income (expense), net |
|
|
(291 |
) |
|
|
2,494 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,057 |
) |
|
$ |
(2,367 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share - basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted |
|
|
25,804 |
|
|
|
19,105 |
|
Celsion
CorporationSelected Balance Sheet
Information(in thousands)
|
|
March 31, 2020(Unaudited) |
|
|
December 31,2019 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,746 |
|
|
$ |
6,875 |
|
Investment securities and interest receivable on investment
securities |
|
|
9,910 |
|
|
|
8,007 |
|
Receivable on sale of deferred tax asset |
|
|
1,820 |
|
|
|
– |
|
Prepaid expenses and other current assets |
|
|
1,401 |
|
|
|
1,353 |
|
Total current assets |
|
|
18,877 |
|
|
|
16,235 |
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
375 |
|
|
|
405 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
Deferred tax asset |
|
|
-– |
|
|
|
1,820 |
|
In-process research and development |
|
|
15,736 |
|
|
|
15,736 |
|
Goodwill |
|
|
1,976 |
|
|
|
1,976 |
|
Operating lease right-of-use assets, net |
|
|
1,339 |
|
|
|
1,432 |
|
Other intangible assets, deposits and other assets |
|
|
634 |
|
|
|
674 |
|
Total other assets |
|
|
19,685 |
|
|
|
21,638 |
|
Total
assets |
|
$ |
38,937 |
|
|
$ |
38,278 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
4,255 |
|
|
$ |
5,166 |
|
Notes payable – current portion |
|
|
2,276 |
|
|
|
1,840 |
|
Operating lease liability – current portion |
|
|
399 |
|
|
|
388 |
|
Deferred revenue - current portion |
|
|
500 |
|
|
|
500 |
|
Total current liabilities |
|
|
7,430 |
|
|
|
7,894 |
|
|
|
|
|
|
|
|
|
|
Earn-out milestone liability |
|
|
5,759 |
|
|
|
5,718 |
|
Notes payable – noncurrent portion |
|
|
7,624 |
|
|
|
7,963 |
|
Operating lease liability – non-current portion |
|
|
1,040 |
|
|
|
1,144 |
|
Deferred revenue and other liabilities - noncurrent portion |
|
|
875 |
|
|
|
1,000 |
|
Total liabilities |
|
|
22,728 |
|
|
|
23,719 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock |
|
|
293 |
|
|
|
232 |
|
Additional paid-in capital |
|
|
311,571 |
|
|
|
304,886 |
|
Accumulated other comprehensive gain (loss) |
|
|
4 |
|
|
|
43 |
|
Accumulated deficit |
|
|
(295,574 |
) |
|
|
(290,517 |
) |
|
|
|
16,294 |
|
|
|
14,644 |
|
Less: Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total
stockholders’ equity |
|
|
16,209 |
|
|
|
14,559 |
|
Total liabilities and stockholders’ equity |
|
$ |
38,937 |
|
|
$ |
38,278 |
|
# # #
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