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LYNDON MARTIN W.

1255 GANNON DR #95801


HOFFMAN ESTATES, IL 60195-0801
BEHARRY LMBEHARRY@LMBESLLC.COM
WWW.LMBESLLC.COM BUSINESS: 224 342 2270
HTTPS://WWW.LINKEDIN.COM/IN/LMBEHARRY/ LAT/LON: N 42.0496085 W 88.107034

Imunon, Inc. Quick Take


Rec Buy/Hold | 08-September-2023
Novel Approaches to harnessing the power of the immune system: Developing new medicines Current Market Price 1.15
that harness the building blocks of life to work in harmony with the body’s immune system. Target Price 15.00
Imunon, Inc. | IMNN FEIN: 52-1256615 Dividend | Yield 00.00 | 0.000%
Growth Expectation 1000.00% +
IMUNON, INC., a clinical stage biotechnology company, engages in the
development of immunotherapies and vaccines to treat cancer and infectious Investment Period Fifteen months +
diseases. The Company's lead clinical programs include IMNN-001, a DNA-based
immunotherapy for the localized treatment of ovarian cancer that is in Phase II
STOCK INFO $USD 2023-08-22
clinical development, and ThermoDox i for the treatment of hepatocellular
carcinoma. It also has two platform technologies: 1) TheraPlas® platform for the Sector SIC 8731: Bio Research
development of immunotherapies and other anti-cancer nucleic acid-based Market Cap 10.500 Million
therapies; and 2) PLACCINE platform for the development of nucleic acid Total Debt (12/2022) 1.360 Million
vaccines for infectious diseases and cancer. The company was formerly known Beta 2 2.09
as Celsion Corporation and changed its name to Imunon, Inc. in September 2022. 52 Wk High | Low 2.56 | 1.06
Imunon, Inc. was founded in 1982 and is based in Lawrenceville, New Jersey. 1 Avg Daily Volume (3 mo) 30 Thousand Shares
Imunon first emerged in 1982 as Cheung Laboratories with a vision of using Book Value (per share) 2.33
thermotherapy to treat cancer and other diseases. ii The small research endeavor Ticker NSDQ: IMNN
persevered under a sequence of private equity placement arrangements and IRS EIN 52-1256615
bridge financing. By spring 1999 Celsion Corporation had materialized on the
American Stock Exchange. At this time, the company was actively pursuing
international sales for ThermoDox, a proprietary mechanism to target deliver INSTITUTION INVESTORS: @ 2022/12/31
potent chemotherapy to cancer sites. ThermoDox uses focused microwave to Vanguard Group Inc. ≈ 1.30 %
heat liposome-encapsulated medications at the cancer/tumor site. In this way, Renaissance Technologies ≈ 0.79 %
the chemotherapy remains concentrated. And since the drugs emerge directly Blackrock, Inc. ≈ 0.72 %
Citadel Advisors LLC ≈ 0.55 %
within the tumor, the body is emancipated from the debilitating effects of toxins.
OTHERS IN THE MARKET:
During the early 2000s, poor management (particularly an ill-conceived stock Free Float (All Holders) ≈ 9.32 Million | 100%
split 13-for-1) cratered Celsion equity and the share price suffered terrible
INDEX Trend: NSDQ 2020 2021 2022
erosion. The company moved to the Nasdaq exchange in 2008. And while the
firm successfully marketed ThermoDox in several international markets, CAGR (2000-Year) 6.18% 6.31% 5.14%

licensing revenue peaked at only $500k per annum. After a reverse stock split Y-o-Y Growth 47.88% 29.59% -33.47%
(2006: 1-for-15), Celsion restructured in the 2010s, retiring the first generation 23-Yr Chart: (2000/01/03 2023/08/28) IMNN | IXIC
of managers. New leadership aggressively pursued CRISPR research and new
DNA plasmid-based therapeutics targeting under-served cancer specialties
(breast, ovarian and liver cancers, in particular). Finally in 2022, Celsion
completed its transition to a leading-edge R&D and marketing biotech/pharma
entity, hiring Corinne LeGoff as CEO and changed its name to Imunon. The firm
currently boasts an excellent pipeline of anti-viral and cancer therapeutics
managed by talented, seasoned medical and pharmacological experts.
Key Financials 2016 2017 2018 2019 2020 2021 2022
‘000 $USD (Except Per Share Values)
Net Sales 2016 2017 2018 2019 2020 2021 2022
% Change 500 500 500 500 500 500 500
Net profit 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%
% Change -22,054 -20,402 -11,883 -16,852 -21,484 -20,769 -35,898
Depreciation / Amortization -1.81% -7.49% -41.75% 41.81% 27.49% -3.32% 72.84%
EBIT Margin 1,023 553 357 722 742 703 732
EBIT Margin % Revenue -21,331 -20,310 -21,590 -17,275 -22,037 -21,583 -32,437
EBITDA Margin -4266.15% -4062.08% -4318.09% -3454.92% -4407.41% -4316.56% -6487.33%
EBITDA Margin % Revenue -20,308 -19,757 -21,234 -16,553 -21,296 -20,880 -31,705
interest Expense -4061.58% -3951.48% -4246.72% -3310.59% -4259.10% -4175.98% -6341.00%

Interest % Revenue 723 92 712 1,393 1,292 570 5,029


Times Interest Earned (EBIT:Interest) 144.60% 18.35% 142.41% 278.68% 258.47% 113.98% 1005.72%
The Interval: 1999 - Present. The Nasdaq (Green) has outpaced Imunon, Inc.
EPS N/A
Digitally signed by N/A N/A N/A N/A N/A N/A
(Purple) by 14000%. Heretofore, IMNN has been an R&D firm with no revenue.
18c36584-5d61-4399-809a-
ea4d01150d00
DN: cn=18c36584-5d61-4399-809a-
ea4d01150d00
Date: 2023.10.24 21:49:22 -05'00'
1
Yahoo! Finance IMNN Profile at 2023-08-22.
2
Yahoo! Finance IMNN Statistics at 2023-08-22.

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IMUNON, INC. OVERVIEW: TIMELINE


1980-1999: (cont.)
1982 2000s
Augustine Cheung founded Cheung Laboratories Inc. in
Columbia, Maryland: purposed "to make microwave 2001
technology an important component in the treatment of Celsion shifted from a medical device maker to a drug
breast and other cancers ..." iii developer. Lawrence Olanoff (formerly with Forest
Laboratories) replaced Cheung as CEO.
1996
Cheung Laboratories entered a licensing agreement to 2006
commercialize its patented bi-modal approach combining Regarding the Adaptive Phase Array "APA" breast
microwave hyperthermia systems with compression to treat cancer treatment, Augustine Cheung (founder)
Benign prostatic hyperplasia BPH on an out-patient basis. iv lamented that Celsion “ha(d) lacked the resources to
bring those technologies to market in addition to some
1999 of its other projects." Dr. Cheung resigned from his
30 September 1998 positions as Chief Scientific Officer and Board member.
First appearance of Celsion Corp 10K for year ending 30 Cheung acquired Celsion's Canadian subsidiary Celsion
September 1998. The 10K (p. 1): “Celsion Corporation (the Ltd. for $1.5 Million and a note for additional $18.5
"Company") was incorporated in the State of Maryland in Million compensation if he succeeded with developing
1982 under the name A.Y. Cheung Associates, Inc. The and marketing the APA technology.
Company changed its name to Cheung Laboratories, Inc. on
June 31, 1984 and to Celsion Corporation on May 1, 1998. The 2009
Company is a biomedical research and development US FDA granted orphan drug status for ThermoDox
company headquartered in Columbia, Maryland, dedicated specifically for Hepatocellular carcinoma HCC.
to creating and marketing medical treatment systems for
cancer, benign prostatic hyperplasia ("BPH") and other Celsion commenced a dose-escalating ThermoDox®
diseases using focused heat energy.” v Phase I/Phase II clinical trial for patients with recurrent
chest wall RCW breast cancer. The study evaluated 109
“The Company (positioned itself toward) the development of patients at ten clinical sites in the United States for
two acquired technologies: (I) from MIT, APA targeting of statistically significant durable complete local
microwave energy, which the Company believe(d) (had) response: that the detectable chest wall tumors had
broad cancer and other medical applications, and (ii) balloon disappeared for at least three months.
catheter technology for enhanced thermotherapy of BPH and
other genitourinary tract conditions. While the balloon Celsion developed a stable heat activated liposomal
catheter technology (was) related to the Company's previous formulation of Docetaxel and demonstrated its
BPH thermotherapy devices, the Company believe(d) the APA statistically significant tumor inhibition in animal
technology ha(d) the potential to serve as the core studies compared both to free Docetaxel and a non-
technology for a broad array of medical devices.” vi heat sensitive formulation. vii

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IMUNON INC. OVERVIEW: TIMELINE (CONT.) (cont.)


2014 January
2010-2019 “Celsion announced that the OS (overall survival) data
from the post-hoc analysis of results from the HEAT
2010 Study support continued clinical development through
By 2010 Celsion had realized successful results in its global a prospective pivotal Phase III Study. The post-hoc data
400+ patient Phase III HEAT study testing the efficacy of suggest that ThermoDox may substantially improve
ThermoDox in combination with radio frequency ablation overall survival, when compared to the control group,
RFA to treat primary liver cancer for progression free in patients whose lesions undergo optimized RFA
survival PFS with a secondary confirmatory endpoint of treatment for 45 minutes or more. The most recent
overall survival. Patients from eleven countries (Canada, post-hoc analysis data from the HEAT Study announced
China, Hong Kong, Italy, Japan, Korea, Malaysia, in February 2015 demonstrate that the patient
Philippines, Taiwan, Thailand, and the U.S.) viii subgroup in the ThermoDox arm whose RFA procedure
lasted longer than 45 minutes (285 patients or 41% of
2012 the study patients), experienced a 59% improvement
Celsion incepted a long-term contract with mainland China in overall survival, with a Hazard Ratio of 0.628 (95% CI
pharma company Hisun to produce ThermoDox at its 0.420 - 0.939) and a P-value of 0.02. A multivariate
China, Hong Kong, and Macau facilities. analysis supported the hypothesis that RFA TIME is the
determining factor in improving OS. This information
should be viewed with caution since it is based on a
Celsion contracted with Philips Healthcare, a division of
retrospective analysis of a subgroup that has not
Royal Philips Electronics, to evaluate the combination of
reached its median point for the overall survival
Philips’ high intensity ultrasound (HIFU) with ThermoDox
analysis. We may choose to end this analysis of overall
to determine the potential of this combination to treat a survival once the median is reached for both arms of
broad range of cancers. ix the study.” xi

Celsion announced other studies testing HIFU with 2014 June Acquisition of EGEN
ThermoDox in U.S. and U.K. research hospitals. On June 20, 2014, the Company completed the
acquisition of substantially all of the assets of EGEN,
2013 January Inc. (EGEN) pursuant to an Asset Purchase Agreement
Extensive review of the HEAT study in patients with (EGEN Asset Purchase Agreement)... In the acquisition,
hepatocellular carcinoma (HCC) confirmed that the HEAT (the Company) purchased GEN-1, a DNA-based
study DID NOT MEET THE GOAL of demonstrating persuasive immunotherapy for the localized treatment of ovarian
evidence of clinical effectiveness (i.e., 33% improvement and brain cancers, and three platform technologies for
in Progression Free Survival PFS at p=0.05) that could form the development of treatments for those suffering
the basis for regulatory approval. x (In 2013, this was a with difficult-to-treat forms of cancer, novel nucleic
major let-down for Celsion followers, including this analyst. acid-based immunotherapies and other anti-cancer
Nevertheless, the analyst recalls that Celsion was DNA or RNA therapies, including TheraPlas™ and
faultlessly transparent and promptly published the TheraSilence™. xii
ambivalent results disclosing reduced prospects for
2014 July
commercial exploitation of ThermoDox-RFA for liver
“The Company announced interim data from the
cancer.)
DIGNITY Study of ThermoDox in RCW Breast Cancer. Of
the 14 patients enrolled and treated, ten were eligible
Hisun paid Celsion a non-refundable R&D fee of $5 million
for evaluation of efficacy. Based on data available to
sponsoring Celsion for continued ThermoDox research, in date, approximately 60% of patients experienced a
exchange for technical expertise and a transfer of research stabilization of their highly refractory disease with a
results to Hisun to satisfy China regulatory requirements. local response rate of 50% observed in the ten
For the promise of an additional $5 million due within a evaluable patients, notably three complete responses,
specified option period, Hisun also incepted an option two partial responses and one patient with stable
agreement to enter into exclusive China license for disease. These data are consistent with the combined
manufacture and commercialization of ThermoDox in clinical data from the two Phase I trials.” xiii

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(cont.)
IMUNON INC. OVERVIEW: TIMELINE (CONT.) 2015 September
(The Company) announced enrollment of the first patient in the
OVATION Study. The OVATION Study will seek to identify a safe,
2015 January Early Access Program for ThermoDox for the tolerable and potentially therapeutically active dose of GEN-1 by
Treatment of Patients with RCW Breast Cancer recruiting and maximizing an immune response and is designed to enroll
three to six patients per dose level...to define an optimal dose for a
“The Company entered into an Early Access Agreement
follow-on Phase I/II study combining GEN-1 with Avastin® and Doxil®. In
with Impatients N.V., a Netherlands company addition, the OVATION Study establishes a unique opportunity to assess
(Impatients), pursuant to which Impatients will develop how cytokine-based compounds such as GEN-1, directly affect ovarian
cancer cells and the tumor microenvironment in newly diagnosed
and execute through its brand myTomorrows an early patients. The study is designed to characterize the nature of the immune
access program for ThermoDox in all countries of the response triggered by GEN-1 at various levels of the patients’ immune
European Union territory, Iceland, Liechtenstein, Norway system, including:
• infiltration of cancer fighting T-cell lymphocytes into primary tumor
and Switzerland (the Territory) for the treatment of and tumor microenvironment including peritoneal cavity, which is
patients with RCW breast cancer. Under the early access the primary site of metastasis of ovarian cancer;
program, Impatients will engage in activities to secure • changes in local and systemic levels of immuno-stimulatory and
immunosuppressive cytokines associated with tumor suppression
authorization, exemption or waiver from regulatory and growth, respectively; and expression profile of a
authorities for patient use of ThermoDox that may comprehensive panel of immune related genes in pre-treatment
and GEN-1-treated tumor tissue.
otherwise be subject to approvals from such regulatory
authorities before the sale and distribution of (The Company) initiated the OVATION Study at four clinical sites at the
ThermoDoxin the relevant territories. (The Company University of Alabama at Birmingham, Oklahoma University Medical
Center, Washington University in St. Louis and the Medical College of
would) be responsible for the manufacture and supply of Wisconsin. During 2016 and 2017, (the Company) announced data from
quantities of ThermoDox to Impatients for use in the Early the first four cohorts of patients in the OVATION Study, respectively. The
Access Program and Impatients will distribute and sell first four cohorts each enrolled three patients. Enrollment of three
additional patients in the fourth cohort is ongoing, and Celsion expects
ThermoDox pursuant to such authorization, exemptions or to complete the OVATION Study in the first half of 2017. Future studies
waivers.” xiv of GEN-1 may include a Phase I/II study combining GEN-1 with Avastin®
and Doxil®. The results of the OVATION Study to date are as follows:
Totality of Results in the First Four Cohorts
2015 January • Of the first twelve patients dosed, one (1) patient demonstrated a
“(The Company) announced that (it) submitted to the FDA complete response (“CR”), eight (8) patients demonstrated partial
response (“PR”) and three patients demonstrated stable disease
a Phase I clinical trial protocol for GEN-1 for the treatment (“SD”), as measured by RECIST criteria. This translates to a 100%
of ovarian cancer. The protocol, developed with guidance disease control rate (“DCR”) and 75% objective response rate
from the Company’s Medical Advisory Board, is designed (“ORR”).
• Eleven patients had successful resections of their tumors, with six
to establish a safe dose and biological activity of GEN-1 in (6) patients having an R0 resection, which indicates a
newly diagnosed ovarian cancer patients who will be microscopically margin-negative resection in which no gross or
undergoing neoadjuvant chemotherapy. The clinical trial microscopic tumor remains in the tumor bed, and four (4) patients
with a R1 resection, indicating microscopic residual tumor. One
will identify a safe, tolerable and potentially patient had an R2, indicating macroscopic residual tumor. One
therapeutically active dose of GEN-1 while maximizing an patient in the second cohort was ineligible for debulking surgery
due to a medical complication unrelated to the study or the study
immune response with the potential to identify an drug.
enhanced population for definitive study. • Of the eleven surgically treated and evaluable patients, one patient
demonstrated a complete pathological response (“cPR”), five (5)
patients demonstrated a micro pathological response (“microPR”),
2015 February and five (5) patients demonstrated a macroPR. These data compare
(The Company) announced that the FDA ha(d) accepted, favorably to historical data, which indicate that cPRs are typically
without comment, the Phase I dose-escalation clinical trial seen in less than 7% of patients receiving neoadjuvant
chemotherapy followed by surgical resection. cPRs have been
of GEN-1 in combination with the standard of care in neo- associated with a median overall survival of 72 months, which is
adjuvant ovarian cancer. The trial is designed to enroll more than three years longer than those who do not experience a
cPR. In addition, microPRs are seen in approximately 30% of
three to six patients per dose level and will evaluate safety patients, and are associated with a median overall survival of 38
and efficacy and attempt to define an optimal dose to months.
carry forward into a Phase II trial. (The Company) • All eleven patients who completed treatment follow-up
experienced a dramatic (greater than 90%) drop in their CA-125
expect(ed) to initiate enrollment for the trial in the second protein levels as of their most recent study visit. CA-125 is used to
half of 2015 at five to six U.S. clinical centers.” xv monitor certain cancers during and after treatment. CA-125 is
present in greater concentrations in ovarian cancer cells than in
other cells. A 50% reduction in CA-125 levels is considered
meaningful.

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IMUNON INC. OVERVIEW: TIMELINE (CONT.)


2015-2018 (cont.)
The Company continued various offshoot studies testing the efficacy of
ThermoDox RFA therapy for liver cancer and breast cancer, while 2020-Present
pursuing greater exuberance in trials of GEN-1 (IL-12 DNA PLASMID
VECTOR ENCASED IN A NANOPARTICLE DELIVERY SYSTEM).
2022 10-K
2017 November OVATION 2 Study The Company announced its Next Generation
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 Vaccine Initiative
ovarian cancer. The protocol is designed with a single dose escalation Imunon’s vaccine candidate comprises a single
phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while plasmid vector containing the DNA sequence
maximizing an immune response. The Phase I portion of the study will
be followed by a continuation at the selected dose in 130 patient
encoding multiple SARS-CoV-2 antigens. Delivery
randomized Phase II study. The study protocol is summarized below: will be evaluated intramuscularly, intradermally,
• Open label, 1:1 randomized design or subcutaneously with a non-viral synthetic DNA
• Enrollment up to 130 patients with Stage III/IV ovarian cancer delivery carrier that facilitates vector delivery into
patients at ten U.S. centers
• Primary endpoint of improvement in progression-free survival (PFS)
the cells of the injected tissue and has potential
comparing GEN-1 with neoadjuvant chemotherapy versus immune adjuvant properties. Unique designs and
neoadjuvant chemotherapy alone. formulations of Imunon vaccine candidates may
2018-2019 offer several potential key advantages. The
The Company continued to develop its GEN-1 and TheraPlas DNA synthetic polymeric DNA carrier is an important
plasmid-delivery gene therapy technologies. Celsion noted certain
significant positive results.
component of the vaccine composition as it has
the potential to facilitate the vaccine
2018 August
(The Company) completed enrollment of 556 patients in the Phase III
immunogenicity by improving vector delivery and,
OPTIMA Study in August 2018. Data for the study will be reviewed as it due to potential adjuvant properties, attract
matures up to two interim analyses expected to be conducted in the professional immune cells to the site of vaccine
second half of 2019 and in mid-2020. (The Company) expect(s) that the delivery.
final efficacy analysis, if necessary, will be completed in early 2021. If
the study proves to provide a clinically meaningful improvement in Future vaccine technology will need to address
overall survival, Celsion will immediately apply for marketing viral mutations and the challenges of efficient
authorization in the US, Europe and China. ThermoDox® has received manufacturing, distribution, and storage. We
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.
believe an adaptation of our TheraPlas
Additionally, the U.S. FDA has provided ThermoDox® with a 505(b)(2) technology, PLACCINE, has the potential to meet
registration pathway. Subject to a successful trial, the OPTIMA Study these challenges. Our approach is described in our
has been designed to support registration in all key primary liver cancer provisional patent filing and is summarized as a
markets. We fully expect to submit registrational applications in the
U.S., Europe and China. We expect to submit and believe that
DNA vaccine technology platform characterized
applications will be accepted in South Korea, Taiwan and Vietnam, by a single plasmid DNA with multiple coding
three other significant markets for ThermoDox® if it were to receive regions. The plasmid vector is designed to express
approval in Europe, China or the U.S.
multiple pathogen antigens. It is delivered via a
2019 March synthetic delivery system and has the potential to
The Company announced final progression free survival (“PFS”) results
be easily modified to create vaccines against a
from the OVATION I Study. Median PFS in patients treated per protocol
(n=14) was 21 months and was 17.1 months for the intent-to-treat multitude of infectious diseases, addressing:
(“ITT”) population (n=18) for all dose cohorts, including three patients • Viral Mutations: PLACCINE may offer broad-
who dropped out of the study after 13 days or less, and two patients spectrum and mutational resistance (variants)
who did not receive full NAC and GEN-1 cycles. Under the current
standard of care, in women with Stage III/IV ovarian cancer undergoing
by targeting multiple antigens on a single
NAC, their disease progresses within about 12 months on average. The plasmid vector.
results from the OVATION I Study support continued evaluation of GEN- • Durable Efficacy: PLACCINE delivers a DNA
1 based on promising tumor response, as reported in the PFS data, and
plasmid-based antigen that could result in
the ability for surgeons to completely remove visible tumor at interval
debulking surgery. GEN-1 was well tolerated, and no dose-limiting durable antigen exposure and a robust vaccine
toxicities were detected. Intraperitoneal administration of GEN-1 was response to viral antigens.
feasible with broad patient acceptance.

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IMUNON INC. PIPELINE AND R&D


Augustine Cheung founded and cultivated Imunon’s predecessor companies in the 1980s-2000s specifically to perfect
thermotherapies for cancers. Over the decades, these companies: Cheung Laboratories and Celsion together with their university
and research hospital partners worldwide have brought significant breakthroughs to cancer research and therapeutics. Most
recently, IMNN has completed Phase Trial studies focused upon proprietary gene therapies and patented DNA PlaCCine delivery
systems. The analyst posts this table as an indication of Imunon’s immediate review of Pipeline 3 potential
(https://clinicaltrials.gov/):

NCT
STUDY TITLE STUDY STATUS CONDITIONS INTERVENTIONS STUDY TYPE
NUMBER

Study of IMNN-001 (Also Known as


ACTIVE_NOT_RECRUITIN Epithelial Ovarian Cancer|Fallopian Tube BIOLOGICAL: IMNN-001|DRUG:
NCT03393884 GEN-1) With NACT for Treatment of INTERVENTIONAL
G Cancer|Primary Peritoneal Cancer Carboplatin|DRUG: Paclitaxel
Ovarian Cancer (OVATION 2)
Phase 1/2 Study of ThermoDox with
Approved Hyperthermia in Treatment DRUG: ThermoDox in combination with
NCT00826085 COMPLETED Breast Cancer INTERVENTIONAL
of Breast Cancer Recurrence at the Microwave Hyperthermia (heat)
Chest Wall
DRUG: ThermoDox® (LTLD)|DEVICE: Focused
Ultrasound of Target Liver
Tumour|DIAGNOSTIC_TEST: Pre-LTLD Biopsy
of Target Liver Tumour|DIAGNOSTIC_TEST:
Targeted Chemotherapy Using Focused
NCT02181075 COMPLETED Liver Tumour Post-LTLD Biopsy of Target Liver INTERVENTIONAL
Ultrasound for Liver Tumours
Tumour|DIAGNOSTIC_TEST: Post-LTLD+FUS
(Post-FUS) Biopsy of Target Liver
Tumour|DEVICE: Thermometry of Target
Tumour
Liposomal Doxorubicin and Thermal DRUG: pegylated liposomal doxorubicin
NCT00061867 Therapy in Treating Patients with COMPLETED Prostate Cancer hydrochloride|PROCEDURE: hyperthermia INTERVENTIONAL
Prostate Cancer treatment
Study of ThermoDox with Standardized
Radiofrequency Ablation (RFA) for
NCT02112656 COMPLETED Hepatocellular Carcinoma DRUG: ThermoDox|DRUG: Dummy infusion INTERVENTIONAL
Treatment of Hepatocellular Carcinoma
(HCC)
Study of Safety & Biological Activity of
IP IMNN-001 (Also Known as GEN-1) Epithelial Ovarian Cancer|Fallopian Tube
NCT02480374 COMPLETED BIOLOGICAL: IMNN-001 INTERVENTIONAL
With Neoadjuvant Chemo in Ovarian Cancer|Primary Peritoneal Cancer
Cancer
Phase 3 Study of ThermoDox with
Radiofrequency Ablation (RFA) in DRUG: ThermoDox|DRUG: 5% Dextrose
NCT00617981 COMPLETED Hepatocellular Carcinoma INTERVENTIONAL
Treatment of Hepatocellular Carcinoma Solution
(HCC)
A Study of ThermoDox in Combination
with Radiofrequency Ablation (RFA) in Hepatocellular Carcinoma|Liver
NCT00441376 COMPLETED DRUG: ThermoDox INTERVENTIONAL
Primary and Metastatic Tumors of the Neoplasms
Liver
Phase II IMNN-001 (Also Known as GEN-
1) on SLL With BEV and NACT, Newly Ovarian Cancer|Fallopian Tube DRUG: Paclitaxel|DRUG: Carboplatin|DRUG:
NCT05739981 RECRUITING INTERVENTIONAL
Diagnosed Advanced Ovarian, Fallopian Cancer|Primary Peritoneal Cancer Bevacizumab|DRUG: IMNN-001
Tube or Primary Peritoneal Cancer
Phase 2 Study of ThermoDox as
DRUG: Lyso-Thermosensitive Liposomal
Adjuvant Therapy with Thermal
NCT01464593 TERMINATED Colon Cancer Liver Metastasis Doxorubicin|OTHER: 5% Dextrose INTERVENTIONAL
Ablation (RFA) in Treatment of
Solution|DRUG: ThermoDox
Metastatic Colorectal Cancer(mCRC)
DRUG: cyclophosphamide|DRUG: doxorubicin
Combination Chemotherapy with or
hydrochloride|PROCEDURE: conventional
Without Microwave Thermotherapy
NCT00036985 UNKNOWN Breast Cancer surgery|PROCEDURE: neoadjuvant INTERVENTIONAL
Before Surgery in Treating Women with
therapy|PROCEDURE: thermal ablation
Locally Advanced Breast Cancer
therapy
PROCEDURE: conventional
Microwave Thermotherapy in Treating
surgery|PROCEDURE: neoadjuvant
NCT00036998 Women with Stage I or Stage II Breast UNKNOWN Breast Cancer INTERVENTIONAL
therapy|PROCEDURE: thermal ablation
Cancer
therapy
Painful Bone Metastases|Breast
MRI Guided High Intensity Focused
Carcinoma|Non-small Cell Lung DRUG: High Intensity Focused Ultrasound
NCT01640847 Ultrasound (HIFU) and ThermoDox for WITHDRAWN INTERVENTIONAL
Cancer|Small Cell Lung (HIFU) in combination with ThermoDox
Palliation of Painful Bone Metastases
Cancer|Adenocarcinoma
DRUG: ThermoDox (Thermally Sensitive
Heat-Activated Target Therapy of Local-
Liposomal Doxorubicin)|RADIATION:
NCT02850419 Regional Relapse in Breast Cancer WITHDRAWN Breast Cancer INTERVENTIONAL
Radiation Therapy|DEVICE: Superficial
Patients
Hyperthermia
Pancreatic Ductal
PanDox: Targeted Doxorubicin in Adenocarcinoma|Pancreatic Cancer DEVICE: Focused Ultrasound|DRUG:
NCT04852367 WITHDRAWN INTERVENTIONAL
Pancreatic Tumours Stage IV|Pancreatic Cancer Non- Doxorubicin|DRUG: ThermoDox
resectable|Pancreatic Cancer Metastatic

3 This list is not comprehensive. Imunon conducts studies with research hospitals, governments, and international agencies such as WHO in other jurisdictions outside of the USA.
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PESTLE: CHARACTERISTICS
Derived principally from IMNN FY 2022 10-K; and IH 2023 10Q Legal
Economic Resolved:
 2023 - 1H2024: The analyst expects annual revenue of $500k per  29 October 2020, a putative securities class action was
annum for ongoing royalties for ThermoDox® licensing; filed against the Company and certain of its officers and
 4Q2024 - FY2025: The analyst projects the appearance of directors (the “Spar Individual Defendants”) in the U.S.
revenue of $7,000k ($7 Million) emerging from Pipeline research: District Court for the District of New Jersey, captioned
1) PlaCCine modality system for Covid-19, influenza and other Spar v. Celsion Corporation, et al., Case No. 1:20-cv-
novel viruses; and also 2) OVATION 2. This $7M figure is a low- 15228. The plaintiff alleged that the Company and
ball assessment to affirmatively arrive at $10M revenue during Individual Defendants made false and misleading
FY 2026, assuming a low/moderate 20% revenue growth rate. statements regarding one of the Company’s drug
Other analysts will impute different parameters. candidates, ThermoDox®, and brought claims for
damages under Section 10(b) of the Exchange Act and
 Peer Group Research and ‘000s 2021 2022
Rule 10b-5 promulgated thereunder against all
Development Expenditure: IMNN 703 732
Defendants, and under Section 20(a) of the Exchange Act
o This notation is solely for illustrative HILS 1,843 2,278
ERNA 12,705 10,392 of 1934 against the Individual Defendants. The Company
purposes. The analyst has not
PCSA 6,878 11,494 believes that the case is without merit and defended it
conducted exhaustive review of the LSTA 17,576 13,067
peer group’s pipeline of research
vigorously. On 06 February 2023, the U.S. District Court
FRTX 28,231 14,043
endeavors. These figures only MBRX 14,418 18,968 granted a Motion to Dismiss filed by the Company and
illustrate the range of R&D QNCX 60,795 25,178 Spar Individual Defendants and granted Plaintiff leave to
ATXS 15,552 34,264 file an amended complaint within 30 days. “Plaintiff did
expenditure among start-up biotech GNFT 35,166 35,818
firms within IMMN’s peer group. not file an amended complaint within the 30-day
 Vaccine Market: Due to the Covid-19 pandemic, the global trade deadline.”
in vaccines surged 26% Y-o-Y (2020-2021) to $USD 41B during  In August 2021, a complaint regarding a corporate books
2021 from $USD 32.6B in 2020. Belgium, China, Germany, Spain, and records demand was filed against the Company in the
and the U.S. accounted for nearly 75% of total 1H 2021 exports. xvi Court of Chancery of the State of Delaware, captioned
 Our globally interconnected world offers novel opportunities for Pacheco v. Celsion Corporation, Case No. 2021-0705. The
nefarious pathogens to emerge into the human ecosystem, plaintiff alleged he was entitled to inspect the Company’s
bringing dangers to health and safety, interrupting trade, and books and records concerning the OPTIMA Study and
wreaking havoc upon our fine-tuned civilization. This becomes other materials. On May 31, 2023, the Court of Chancery
more problematic as heretofore inaccessible territories in Africa entered the parties’ stipulation dismissing the case
and Asia, and parts of Central and South America open up to without prejudice.
global economic intercourse.  In October 2021, an arbitration was commenced against
o “Anthony Fauci, who retired as head of the National the Company before the CPR Institute for Conflict
Institute of Allergy and Infectious Diseases, National Prevention & Resolution, captioned Curia New Mexico,
Institutes of Health, at the end of 2022, wrote that “The LLC v. Celsion Corp., Case No. G-22-85-S. The claimant
emergence of new infections and the reemergence of old alleged that the Company failed to pay invoices for the
ones are largely the result of human interactions with and manufacture of two batches of ThermoDox®. On April 19,
encroachment on nature. As human societies expand in a 2023, the arbitral tribunal issued an interim award,
progressively interconnected world and the human– upholding claimant’s claim with respect to one of the two
animal interface is perturbed, opportunities are created, batches of ThermoDox® for an aggregate amount of
often aided by climate changes, for unstable infectious approximately $583,500 including interest and legal fees
agents to emerge, jump species, and in some cases adapt
which was paid in second quarter 2023 and the
to spread among humans.” “ xvii
arbitrators denied their claim with respect to the other
 Imunon has grown a core competency in cutting edge vaccine
technology. Consequently, the company may experience high and
batch of ThermoDox®.
rapid Revenue Growth multiples once it commences commercial
licensing transactions for its PlaCCine immunization platform among Unresolved: Breach of fiduciary duty/other allegations for ThermoDox®:
the major vaccine producers worldwide. The analyst posits that this  In February 2021, a derivative shareholder lawsuit was filed
transition will occur within the immediate 15 months to 2 years. against the Company, as the nominal defendant, and certain
of its directors and officers as defendants in the U.S. District
Court for the District of New Jersey, captioned Fidler v.
Environmental
Michael H. Tardugno, et al., Case No. 3:21-cv-02662. The
 The company is subject to a number of laws and regulations plaintiff alleges breach of fiduciary duty and other claims
forcing compliance with federal, state, and local regulations for arising out of alleged statements made by certain of the
the protection of the environment. The regulatory landscape Company’s directors and/or officers regarding ThermoDox®.
continues to evolve, and additional regulations will emerge in the The Company believes it has meritorious defenses to these
future. National governments and international agencies claims and intends to vigorously contest this suit. At this
implement laws and regulations to mitigate the effects of climate stage of the case neither the likelihood that a loss, if any, will
change mainly caused by greenhouse gas emissions. Imunon’s be realized, nor an estimate of possible loss or range of loss,
business is not energy intensive. The analyst does not anticipate if any, can be determined. On 10 March 2023, the U.S.
that the Company will fall subject to a cap-and-trade system or District Court for the District of New Jersey issued an order
that the action is administratively terminated pending the
other mitigation measures that would materially impact capital
submission, by 17 March 2023, of a joint letter advising as to
expenditures, operations or competitive position.
how the parties wish to proceed in the matter.

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PESTLE: CHARACTERISTICS (CONT.)


Political
 Legislative and regulatory actions periodically affect
government prescription drug procurement and
reimbursement programs. For instance, a 2020 FDA
rule implements a pathway for the import of certain
prescription drugs from Canada. This rule is subject to
ongoing litigation;
 Many U.S. state legislatures have enacted laws to
regulate pharmaceutical drug pricing;
 Successful commercialization of health/pharma
products depends, in part, on the availability and
amount of third-party payer reimbursement for the
products and related treatments and medical services.
As pharma products mature, pricing pressures from
private insurers and government payers often result in
a reduction of the net product prices;
 U.S. Congress enacted the Inflation Reduction Act of
2022: 1) U.S. Dept of Health and Human Services
negotiates Medicare prices for certain drugs; 2)
imposes an inflation-based rebate on Medicare Part B
utilization starting in 2023; 3) restructures the
Medicare Part D benefit to cap out-of-pocket expenses
starting 2024.

Sociological
 Aging and longer-lived Western populations generate
opportunities for pharmaceutical firms to extend brand
loyalties and grow legacy revenue for longer durations;
 Americans have cultivated a perception that
pharmaceutical companies charge exorbitant/unfair
rates for medications. This may work in IMNN’s favor as
it evolves to produce revenue in a lower-price
environment. Unlike existing biotech companies facing
downward pricing pressure, startup: IMNN is initiating
from baseline prices and would only see an upside;
 Post-Covid-19 worldwide appeal for vaccines as a must-
have therapeutic measure may increase interest in
IMNN PlaCCine modality;
 Public interest groups and radical factions assail
pharmaceutical companies for needlessly testing
products on animals (the testing of which often
involves the dissection of the subject to review
pharmacological effects on the organs).
Technological
 Next generation computer programming and AI
algorithms enhance R&D and offer alternatives to
quickly image pathogen biochemical structure and
virus infection pathways. These endeavors may
enhance or circumvent animal and human testing;
 New biochemistry technologies continue to gain
greater efficacy in medication, more efficient
production methods, and non-invasive disease
detection.

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PORTER ANALYSIS IN BRIEF  Intense internal rivalry forces competitors to


invest heavily into marketing (i.e., colloquia,
Internal Rivalry trade shows, marketing fairs, marketing
 Closest competitors: junkets);
Name Stage Specialty Silver Bullet  Biotech-Pharma companies use non-
Discovery, development,
and commercialization of
STAR-0215, a monoclonal
antibody inhibitor of plasma
competition agreements and non-solicitation
ATXS
Astria
Therapeutics, Inc.
BioPharmaceutical
Company
therapeutics for rare and
niche allergic, and
kallikrein, which is in clinical
development stage for the
agreements to forestall the flight of intellectual
immunological diseases in
the United States
treatment of hereditary
angioedema
properties and retain value for extended life-
Eterna
Synthetic mRNA, ToRNAdo
mRNA Delivery, mRNA
cycles;
ERNA Preclinical
Therapeutics Inc. Gene Editing, and mRNA
Cell Reprogramming
FRTX-02 (BBI-02): oral
DYRK1A inhibitor completed
New Entrants
Phase 1 treating
autoimmune and
 Biotech-Pharma is always in vibrant flux, with
Prescription therapeutics
inflammatory diseases
FRTX-10 (BBI-10): covalent
university-level research, independent
FRTX
Fresh Tracks
Therapeutics, Inc.
Clinical
for the treatment of
autoimmune, inflammatory
stimulator of interferon
genes inhibitor potential
individual research, and small start-up research
diseases... treatment of
autoinflammatory and rare
all seeking next-generation reagents and
genetic diseases
FRTX-03: topical DYRK1A
therapies – each seeking a special proprietary
inhibitor treating mild-to-
moderate skin conditions
silver bullet to enter mass production;
Discovers and develops Elafibranor
drug candidates and NIS4 technology for the
Supplier power
BioPharmaceutical
GNFT Genfit S.A. diagnostic solutions for diagnosis of nonalcoholic
Company
metabolic and liver-related steatohepatitis (NASH) and
diseases fibrosis
HSB-1216: IMCD inducer
 Because many production technologies are
targeting solid tumors
HSB-3215: anti-HER2
proprietary, there is little supplier power in the
HILS
Hillstream
Preclinical
Immuno-oncology,
monoclonal antibody
candidate
protected patent phase: the company and its IP
BioPharma, Inc. ferroptosis
HSB-1940: a Quatrabody
that is a proprietary IO
supply inputs to production;
biologic in development
targeting PD-1
 Imunon specializes in licensing proprietary
IMNN-001: DNA-based technologies and processes. Consequently, the
immunotherapy treating
ovarian cancer (Phase II Company relies upon its ability to recruit and
clinical development)
Development of
ThermoDox: treating retain experts in the fields in which it conducts
hepatocellular carcinoma
IMNN Imunon, Inc. Clinical
immunotherapies and
vaccines to treat cancer and
TheraPlas® platform: proprietary research;
immunotherapies and other
infectious diseases
anti-cancer nucleic acid-  New technologies (Biological 3D printing, for
based therapies
PLACCINE platform: nucleic
acid vaccines for infectious
one) may possess initial power in terms of supply
diseases and cancer imbalance for types of biologic/metabolic
LSTA1: Phase 1b/2a and 2b
treating solid tumor, matter;
including metastatic
pancreatic ductal  Some inputs may be dear to manufacture and
adenocarcinoma (mPDAC)...
Innovative therapies for the
HONEDRA: recipient of may be toxic to humans during the production
Lisata SAKIGAKE designation
LSTA
Therapeutics, Inc.
Clinical treatment of solid tumors
and other diseases
critical limb ischemia process;
XOWNA: Phase IIb treatng
coronary microvascular
dysfunction
LSTA201: a CD34+ cell Buyer / Consumer Power
therapy treating chronic
kidney disease  While individual human persons have little buyer
Annamycin: in Phase 1/2
studies treating relapsed or power, insurance groups and other socio-
refractory acute myeloid
leukemia (AML) and cancers political-economic groups possess great
metastasized to the lungs
WP1066: Phase I treating negotiating power and also political power to
brain tumors and pediatric
MBRX
Moleculin
Clinical
Treatment of cancers and brain tumors, pancreatic regulate prices.
Biotech, Inc. viruses cancer and other
malignancies
WP1220: (analog of
WP1066) treating cutaneous Threat of Substitutes
T-cell lymphoma
WP1122: treating  Many Pharmaceutical/Biotech therapies
glioblastoma multiforme
and COVID-19 struggle for market share in contention with
PCS499: oral tablet in Phase
Processa Ulcerative and non-
2B clinical trials treating competitors’ products;
ulcerative and non-
PCSA Pharmaceuticals,
Inc.
Clinical ulcerative necrobiosis
lipoidica
ulcerative necrobiosis  Some Pharmaceutical/Biotech therapies
lipoidica, a chronic
disfiguring condition compete against other properties owned by the
Precision therapeutics for
QNCX
Quince
Therapeutics, Inc.
Preclinical debilitating and rare
NOV004, engineered to
ameliorate bone fracture
same company: CANNIBALIZATION;
 Some consumers are also drawn to the
diseases

alternative / holistic therapies market;


 Intense internal rivalry forces competitors to invest  Most biotech / pharma products exist in
heavily into Research & Development (above table of contention with substitutes – particularly after
peer group); the initial protected patent phase (7-11 years,
typically);

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FINANCIAL MODEL: PROSPECTIVE VIEW Costs of Capital


Heretofore, Imunon, Inc. has thrived as a Research & Development KE
biotechnology firm, with heavy emphasis on RESEARCH. Due to this,
the Company lacks any history of positive FREE CASHFLOW TO EQUITY: The U.S. S&P 500 has posted recent annual returns (2011-
FCFE. Lacking this firm-specific baseline computational reference, 2021) of 14.252%; with long-term (30-year) CAGR of
the analyst built up a prospective FCFE model following the 8.416%. Valuing IMNN, this analyst estimates the Equity
historical efficient performance of GILEAD SCIENCES, INC. (GILD) a Index return of 10.000% for the Capital Asset Pricing
biotech firm which also engages in pharmaceutical research, Model (CAPM):
vaccine development, and gene therapeutics. The analyst derived
costs and expense components as objective functions of GILD E(ri) = rf + β[E(rm)-rf]
Revenue F(Rev), or in the case of Taxation, F(EBT) through analysis = 5.250% + 2.09 X (10.000%-5.250%)
of fifteen years of audited records. The analyst realizes that GILD is = 5.250% + 9.9275%
a mature company with efficiencies garnered through experience = 15.1775%
and marketing endurance. Still, the analyst believes IMNN may well
mimic GILD’s growth trajectory. Alternate:
GORDON DIVIDEND PAYOUT MODEL:
This table recounts the summary of variables used in the Discounted
Book Value of the Firm $USD Thousands 21,515
Cash Flow analysis to isolate: 1) valuation of the Firm’s Free
Book Value Per Share BV0 2.634
CashFlow to Equity; and 2) valuation per common equity share.
Dividend Growth Rate xix (Gordon Model) gn 25.000%
Variables 4 kE = [(RoE xx - gn ) X (BV0 / P0)] + gn 15.543%

CRITERIA (UNITS: ‘000S) BV0 Multiple: P0/BV0 = PBV = “(RoE-gn)/(ke-gn)” 0.486 xxi
CoGS: F(Rev) 13.989% Forecast Share Price from Multiple5.80 X BV0 15.28
Depreciation/Amortization (CoGS): F(Rev) 5.085%
SGA (Only): F(Rev) 15.787% KB Long-Term Debt 10K:2022
R&D: F(Rev) 21.476% MatDate Coupon Value Annual
Depreciation/Amortization (SGA): F(Rev) 0.000% 2022-03-31 6.330% % 0.001 0
2022-09-30 N/A % 0.000 0
Other Expense (Income)/Overhead: F(Rev) 0.000% 2023-09-30 N/A % 0.000 0
Interest Expense (Income): F(Rev) 2.940% 2023-09-30 N/A % 0.000 0
2024-04-30 N/A % 0.000 0
Tax Rate xviii: F(EBT) 21.000% 2025-02-28 N/A % 0.000 0
Capital Expenditures: F(Rev) 6.751% 2026-03-31 N/A % 0.000 0
Working Capital: F(Rev) 15.000% 2027-03-31 N/A % 0.000 0
2027-10-31 N/A % 0.000 0
2030-10-31 N/A % 0.000 0
βeta 2.09 2035-09-30 N/A % 0.000 0
2036-09-30 N/A % 0.000 0
Shares Outstanding (Thousand) 9,100.000 2040-10-31 N/A % 0.000 0
Inflation Rate (Long-term Historical Est.) 2.500% 2041-12-31 N/A % 0.000 0
2044-04-30 N/A % 0.000 0
RF (T-bill annual) Rate 5.250%
2045-02-28 N/A % 0.000 0
CAPM KE Calculation 15.178% 2046-03-31 N/A % 0.000 0
GORDON DIVIDEND GROWTH KE Calculation 15.343% 2047-03-31 N/A % 0.000 0
2050-10-31 N/A % 0.000 0
KB Result 6.330% N/A % 0.000 0
KB Result with Tax Shield 5.0007% N/A % 0.000 0
WACC 11.1323% Totals 0.000 0.00

Market Historical Returns (Est.) 10.000% With Tax xxii Shield (21%) 5.0007%

Revenue Growth Rate (Proj. Est. 10-Yr) 20.000% Weighted Average Cost of Capital
Perpetuity Growth Rate (Inflation) 2.500%
𝐾𝐾 𝐵𝐵+𝐾𝐾 𝐸𝐸 [5.0007%X0.39749]+[15.1775%X0.60251]
𝑊𝑊𝑊𝑊𝑊𝑊𝑊𝑊 = 𝐵𝐵 𝐸𝐸
=
Discussion B+E 1.000
The analyst produced three distinct prospective models of FCFE: 1) [1.98772%] + [9.14461%]
=
Static model varying WACC; 2) Static model varying Revenue 1.000
Growth Rate; and 3) Dynamic multi-iterative Monte Carlo model = 11.13233%
oscillating all variables within a tolerance of 10% coefficient of Market Capitalization Basis; B=Total Debt (adj. with carrying
variability. These models suggest a range of Equity valuation for costs); E = Equity Market Capitalization xxiii
Imunon, Inc. The results page discusses the outcomes of these WACC derives KE from Capital Asset Pricing Model
Equity valuation simulations.

4
The analyst derived these variables as statistical calculations from fifteen years of the proxy reference: Gilead Sciences, Inc. audited financial statements.
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STATIC MODEL: PROSPECTIVE VIEW


Results of the Variable Revenue Growth Rate Results of the Variable WACC Growth Rate

Discussion
The analyst expects the firm will aggressively grow
revenue into the several multiples potentially to
75%-100% Y-oY growth within the next 2-3 years.
Once the firm enters maturity (10+ years), one
expects long-term revenue growth rate of 2.50% -
3.50% (mimicking U.S. long-term inflation +50 to
100 basis points) with some additional upside
potential as new therapeutic properties come
online.

This chart (above) plots IMNN valuations at different


This display reflects per share valuations from a -
rates of capital costs. The expected value per share is
17.50% annual growth rate of revenue ($9.33 per
$10.79 at the calculated WACC: 11.132% (with
share) through 22.50% annual revenue growth Revenue growth: 20%). Higher WACC returns lower
($12.51 per share). The Prospective free cash-flow per share valuations.
to equity analysis returned an expected per share
valuation of $10.79 at a 20.00% growth rate, with
WACC of 11.13%. The reader ought to note that the Discussion
analyst feels these are extreme conservative The analyst expects IMNN weighted average cost of
estimates, with tremendous upside potential. capital to be no less than 11.00%, but it may be higher.
Thus, the Firm would produce true value only through
increased growth in revenue (greater sales volumes or
the unlikely alternative of price hikes).

The Monte Carlo multi-iteration model (100,000 trials)


varies the Weighted Average Cost of Capital to the
following constraints:

Mean WACC: 11.132%


Standard Deviation: 00.22264% (2.0% of the mean)

Hence, the Monte Carlo results would likely capture


the range of capital costs within its 100,000 iterations
Normally distributed.

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MONTE CARLO FINANCIAL MODEL: PROSPECTIVE VIEW Discussion


Overview
The analyst sculpts scenarios with cautious
Monte Carlo quantitative analysis is a statistics-mathematics process.
It mimics real-world volatility to probabilistically predict a range of estimates, aiming to err on the side of
outcomes. The analyst employed the identical variable structure for restraint. The prospective cashflow
both the static and Monte Carlo equity valuation models. BUT, the
Monte Carlo process dynamically alters the factors within defined
models use a mean estimated per annum
constraints. In this instance, Monte Carlo uses the variables as the revenue growth rate of 20.00%, based
statistical mean (probability-weighted average), and fluctuated each upon the analyst’s review of the particular
factor 100,000 times at a standard deviation of 10% of the mean
values of the stated variables according to a Normal Distribution.
subsector and IMNN’s placement in its
R&D pipeline. This Monte Carlo
prospective model also uses conservative
estimates for cost/expense factors: costs
following historical mean percentages,
tempered against industry norms
(following the Gilead Sciences, Inc. proxy).

The reader ought to note that the


projected 20.00% growth rate is
potentially below any expectation of
Results IMNN: IMUNON, INC20.00%: revenue multiple once IMNN begins to
This chart illustrates a potential range VALUATION PER SHARE
CURVE SHAPE Lognormal license its novel PlaCCine technology. In
of valuation for Imunon common
equity per share at a 20.00% growth TRIALS 100,000 other words, this extremely conservative
MEAN 11.76
rate. Using this variable structure, the Discounted Cash Flow Valuation measures
model delivers the following statistics: MEDIAN 11.74
a) an expected median per share price MODE 11.66 prospective potential performance at a
of $11.74; with a b) projected ST DEV 0.8141 potentially low growth rate. In this light,
MINIMUM 8.63
maximum to $15.98. At a base 20.00%
MAXIMUM 15.98
the estimated value of $11.76 per share
revenue growth rate, the simulation
returned a better than 82.00%
signals the low boundary of probable fair
P(VALUE>$11) 82.000%
probability of a fair valuation over $11 valuation.
per share.

An alternative valuation on Book Value


multiple imputes a $15.28 per share
Valuation. The analyst uses the Stern
Business School at NYU estimate of Drugs
(Biotechnology) BV0 Multiple: 5.80 ( Price
to Book Ratios (nyu.edu) ) .

Because of these considerations, the


analyst infers a fair Valuation of $12 - $15
per share, without qualification.

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Sensitivity Analysis

The Monte Carlo FCFE DISCOUNTED CASH FLOW PROJECTION is sensitive to particular conditions. Because the
perpetuity
CashFlow dwarfs
estimated cash-flow
in any given annum,
the terminal year
factors typically
assert control over
the Firm and its
weighted Equity
valuation: 1) 2024
SGA; 2) 2034 R&D;
3) 2034 CoGS; 4)
WACC for
simulation; 5) 2034
Tax xxiv Rate and 6)
2024 Revenue.
The Tornado Chart sensitivity analysis of Imunon valuation with these instant variables imputes a heavy
weighting upon the perpetuity model – likely because of the unknowns: Taxation xxv regime and Revenue
potential. This analyst believes that IMNN has excellent upside potential in its pipeline R&D, especially the
PlaCCine and IMMN-01 modalities for vaccine platform and cancer therapeutics respectively.
Imunon, Inc. Closest Competitors:
NAME STAGE FOCUS FOUNDED
Discovery, development, and commercialization of therapeutics
Astria Therapeutics, BioPharmaceutical
ATXS for rare and niche allergic, and immunological diseases in the 2008
Inc. Company
United States
Eterna Therapeutics Synthetic mRNA, ToRNAdo mRNA Delivery, mRNA Gene Editing,
ERNA Preclinical
Inc. and mRNA Cell Reprogramming
Fresh Tracks Prescription therapeutics for the treatment of autoimmune,
FRTX Clinical 2009
Therapeutics, Inc. inflammatory diseases...
BioPharmaceutical Discovers and develops drug candidates and diagnostic solutions
GNFT Genfit S.A. 1999
Company for metabolic and liver-related diseases
Hillstream BioPharma,
HILS Preclinical Immuno-oncology, ferroptosis 2017
Inc.
Development of immunotherapies and vaccines to treat cancer
IMNN Imunon, Inc. Clinical 1982
and infectious diseases
Lisata Therapeutics, Innovative therapies for the treatment of solid tumors and other
LSTA Clinical 2015
Inc. diseases
Moleculin Biotech,
MBRX Clinical Treatment of cancers and viruses 2015
Inc.
Processa
PCSA Clinical Ulcerative and non-ulcerative necrobiosis lipoidica 2011
Pharmaceuticals, Inc.
Quince Therapeutics,
QNCX Preclinical Precision therapeutics for debilitating and rare diseases 2012
Inc.

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FRAUD ANALYSIS METHODOLOGY OF FORENSIC ANALYSIS TO


Statistics Testing for Anomalous Financial Reporting DETECT FRAUD
Benford’s Test Twenty-first century forensic analysis of
financial records encourages mathematics
and statistics to test anomalies in financial
reporting. The analyst favors two forensic
tests: Benford’s Test, and Beneish’s M-Score.
Note: Forensic Accounting analysis cannot
prove fraud; it simply suggests instances of
potential anomalies in reporting.

Benford’s (First Digits) Law


Benford’s law (First Digits Law) predicts
that the first digits in random sets of
numbers which span across several orders
of magnitude (i.e., ones, tens, hundreds,
Beneish M-Score thousands, etc.) will conform to a set
distribution (the bronze columns).
Because of compounding over time
intervals, the First Digits rule affirms that
there are more instances of numbers
beginning with 1, then 2, then 3, and so
on.
This analysis tested IMNN Balance Sheet
numbers against Benford’s Law. The first
digits of the Balance Sheet numbers fall
very close to expected outcomes; and the
analyst believes this indicates fair and
honest reporting.

The Beneish M-Score calculations


IMNN Beneish scores are excellent for
several years running. They reflect no
anomalous readings.

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OUTLOOK AND RECOMMENDATION


This analyst has been following Imunon, Inc. for a
number of years. During summer 2022, the analyst IMUNON, INC.
initiated an extensive fundamental analysis (15-year
record) and DCF analysis. In July 2022, IMNN was
trading at $2.00, and the DCF pro-forma informed a
RECOMMENDATION
per-share valuation of $Undetermined at that time.
Unfortunately, the analyst had to set aside the report
until August 2023.
BUY / HOLD
The R&D and Trial Studies indicators for Imunon are
unquestionably favorable. The Entity’s core portfolio
of Bio-Pharma properties (in potential sales) is well-
situated, and will grab several years of secure patent Target Return 1000 %
exclusivity ranging from 2024 through 2035 and
beyond. IMNN also possesses an attractive pipeline, $12-$15
complementing its line-up of silver bullet therapies.

And while potential annual sales of IMNN’s key


PlaCCine and IMNN-01 platforms are uncertain,
Imunon’s celebrated diligence in pursuit of innovative
therapies in tandem with the current favorable
testing indicators suggests that the Company is on the Duration: Fifteen Months and More
cusp of a major breakthrough in marketing its
therapeutics. Even with just a fraction of a percentage
DCF and Book Value Multiple Basis
of the greater than $35 Billion worldwide post-
Covid19 vaccine market, IMNN annual Revenue
would achieve within the tens of $USD Millions. And
PlaCCine has such potential and more.
Invest Responsibly…
Lastly, while its history is no definite indicator of You are buying a company!
future performance, IMNN possesses a storied record
of R&D and good science, earning respect among
research facilities and regulatory agencies worldwide.
The analyst expects the Company’s C-Suite will
continue to enhance its portfolio and tradition of
producing disease ameliorating agents suitable for And remember…
international sales. And we ought not forget Africa as It's not the size of the dog in the fight,
a new regime, often overlooked in the past; but a it's the size of the fight in the dog.
young market with huge potentials for growth –
…Mark Twain
particularly in the pharmacological/vaccine industry.

15 of 15 |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


LYNDON MARTIN W. 1255 GANNON DR #95801
HOFFMAN ESTATES, IL 60195-0801
BEHARRY LMBEHARRY@LMBESLLC.COM
WWW.LMBESLLC.COM BUSINESS: 224 342 2270
HTTPS://WWW.LINKEDIN.COM/IN/LMBEHARRY/ LAT/LON: N 42.0496085 W 88.107034

FINANCIAL INDICES

Appendix A of K | © BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix B of K

FINANCIAL INDICES

Appendix B of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix C of K

FINANCIAL INDICES

Appendix C of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix D of K

FINANCIAL INDICES

Appendix D of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix E of K

FINANCIAL INDICES

Appendix E of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix F of K

FINANCIAL INDICES

Appendix F of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix G of K

FINANCIAL INDICES

Appendix G of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix H of K

FINANCIAL INDICES

Appendix H of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix I of K

Appendix I of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix J of K

Appendix J of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


2023-10-24_IMNN-MC-ValuationReport_Draft03C | Appendix K of K

Appendix K of K |© BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM


LYNDON MARTIN W. 1255 GANNON DR #95801
HOFFMAN ESTATES, IL 60195-0801
BEHARRY LMBEHARRY@LMBESLLC.COM
WWW.LMBESLLC.COM BUSINESS: 224 342 2270
HTTPS://WWW.LINKEDIN.COM/IN/LMBEHARRY/ LAT/LON: N 42.0496085 W 88.107034

END NOTES
i
About ThermoDox® (https://investor.celsion.com/news-releases/news-release-details/celsion-corporation-announces-issuance-new-patent-thermodoxr)
Celsion's most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of
difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of
action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox®
is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall
(RCW) breast cancer and non-muscle invading bladder cancers.
Celsion's LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism,
rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a
number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an
external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal
membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug
concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the
tumor and the area related to tumor invasion, supporting more precise drug targeting.
ii
Celsion 2006 10K, p. 1
iii
Sourced directly from https://www.baltimoresun.com/news/bs-xpm-2006-01-18-0601180097-story.html
iv
Sourced from 8-k https://www.sec.gov/Archives/edgar/data/749647/0000749647-96-000003.txt
v
Sourced from https://www.sec.gov/Archives/edgar/data/749647/0000931731-99-000020.txt
vi
Sourced from https://www.sec.gov/Archives/edgar/data/749647/0000931731-99-000020.txt
vii
Docetaxel is marketed worldwide under the name Taxotere by Sanofi-Aventis.
viii
Celsion 2010 10K
ix
Celsion 2012 10-K
x
Celsion 2012 10-K
xi
Celsion 2014 10-K
xii
TheraPlas™ is a technology platform for the delivery of DNA and messenger RNA (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 a 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 that 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. (2014 10-K)
xiii
Celsion 2014 10-K
xiv
Celsion 2014 10-K
xv
Celsion 2014 10-K
xvi
OECD: Vaccinating the World,
https://www.oecd.org/coronavirus/en/vaccines?fbclid=IwAR0QlkEJ0iGWcTaVPPpkY5jeeK2sTPJQyoSKhkA2BZ_GSmNU8j5dNTQpHFY
xvii
Copied in its entirety from: https://wwwnc.cdc.gov/eid/article/29/2/ac-
2902_article#:~:text=As%20human%20societies%20expand%20in,adapt%20to%20spread%20among%20humans.%E2%80%9D
xviii
During the Trump PotUS Administration, Congress passed the Tax Cuts and Jobs Act (TCJA) in 2018, reducing corporate taxes to a flat 21% across the board.
Because of high U.S. debt and annual deficit expenditure, the analyst believes that this ultra-favorable tax regime is not sustainable. The reader should note that
any change in taxation rates will immediately affect Imunon equity valuation.
xix
The analyst plugged a conservative, arbitrary estimate of 10.00% to accommodate risk and inflation.
xx
RoE conservative estimate of 20.00%
xxi
Stern at NYU provides this 5.80 average BV multiple for the Drugs: Biotechnology sector (Price to Book Ratios (nyu.edu))
xxii
During the Trump PotUS Administration, Congress passed the Tax Cuts and Jobs Act (TCJA) in 2018, reducing corporate taxes to a flat 21% across the board.
Because of high U.S. debt and annual deficit expenditure, the analyst believes that this ultra-favorable tax regime is not sustainable. The reader should note that
any change in taxation rates will immediately affect Imunon equity valuation.
xxiii
See the WACC Worksheet for details of each component. The Monte Carlo Workbook algorithm is hard coded to calculate WACC using various methods:
CAPM, Gordon Dividend Growth Model, RoE model, or combinations. In this instant, the system derived the WACC using market capitalization with the then
share price of $1.250 and with weighted number of shares equivalent to the average of 9,370 Thousands (Yahoo Finance value for shares outstanding) and 9,100
Thousands (the 2022-12-31 adj. value). The coded WACC calculation added the Book Value of all Debt (adj. with carrying costs) (B) to the Equity Capitalization
for total Capitalization. The cost of debt (B) was derived above. The cost of Equity emerged from the CAPM with an estimated β eta of 2.09, 10.000% market
returns, and 5.250% rF according to the stated calculations.
Watermark: Science – IMUNON
Pipeline Progress: ClinicalTrials.gov
xxiv
During the Trump PotUS Administration, Congress passed the Tax Cuts and Jobs Act (TCJA) in 2018, reducing corporate taxes to a flat 21% across the board.
Because of high U.S. debt and annual deficit expenditure, the analyst believes that this ultra-favorable tax regime is not sustainable. The reader should note that
any change in taxation rates will immediately affect Imunon equity valuation.
xxv
During the Trump PotUS Administration, Congress passed the Tax Cuts and Jobs Act (TCJA) in 2018, reducing corporate taxes to a flat 21% across the board.
Because of high U.S. debt and annual deficit expenditure, the analyst believes that this ultra-favorable tax regime is not sustainable. The reader should note that
any change in taxation rates will immediately affect Imunon equity valuation.

PAGE I OF SOURCES | © BEHARRY, LYNDON MARTIN W. | 2023-10-24_IMNN-MC-ValuationReport_Draft03C | 10/24/2023 9:47 PM

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