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8/9/2019 Adxs Update q4f10-2
1/20
ADVAXIS, INC. (OTC BB: ADXS) March 08, 20
Price ........................................................................................ $0.1852-Week Range .......................................................... $0.01 - $0.21Market Capitalization ................................................ $22,260,218Enterprise Value ......................................................... $27,165,470Basic Shares Outstanding .......................................... 127,201,243Float (Shares) .............................................................. 105,322,629Insider Ownership (%) ........................................................17.2%Institutional Ownership (%)..................................................9.0%Daily Volume (3-Month Avg.) ....................................... 1,032,860Industry ....................................................................BiotechnologyWebsite ...............................................................www.advaxis.comCorporate Headquarters.............................. North Brunswick, NJ
Company Description
Advaxis, Inc. is a development-stage immune therapy company that is focused on the development of therapeutic canvaccines utilizing attenuated, live Listeria monocytogenes bacteria as a carrier for bioengineered antigens. The Compexclusively licenses this technology from the microbiology laboratory of Dr. Yvonne Paterson at the University of PennsylvaAdvaxis anticipates starting three clinical trials in 2010 that advance its previously completed Phase I clinical trial.
Summary
Whats new Advaxis reported results for its Q4 and fiscal year end, raised additional capital and announced the starthree of its clinical trials. (See page 2, 10 and 15 for details).
Novel immunological treatment for cancer acts as a differentiator At the core of Advaxis product portfolio ispatented delivery system that uses attenuated, live Listeria monocytogenes (Lm) as its vector to deliver the antigen fusprotein Listeriolysin-O (LLO), which elicits a powerful and comprehensive immunological response. While the poweimmunological response comes from both the innate and adaptive tiers, more importantly, Advaxis vaccine elicitsintratumoral affect. This affect inhibits the regulatory T-cells that are acting to hide cancerous cells, thus increasingability of the bodys immune system to fight the existing cancer and improve remission.
Strong IP portfolio - Advaxis has 27 issued and 45 pending patents covering multiple compositions of matter, methods uses for live Listeria-based vaccines. We note that recently, the Company successfully defended a patent in Europe.
Large addressable market targeted According to BCC Research, the estimated global market for immunotherapies reach $37.2 billion by 2012, and within that market, the sector with the greatest potential for growth is cancer vaccines.
Near-term capital infusion potential In September 2009, Advaxis signed an equity line of credit for a maximum of $until September 2012. In January 2010, the Company drew down approximately $1.45M. This leaves approximately $3on the line of credit in which the Company can draw down to help fund its operations.
Valuation Our Comparison Table on page 16 shows the market placing a median enterprise value on cancer biotech firof $115.5M vs. Advaxis enterprise value of $27.2M.
STONEGATE
S E C U R I T I E S
$0.00
$0.02
$0.04
$0.06
$0.08
$0.10
$0.12
$0.14
$0.16
$0.18
$0.20
Mar-09 Apr-09 Jun-09 Jul-09 Sep-09 Oc t-09 Dec -09 Jan-10 Mar-1
FY Oct Revs Net Inc EPS P/E Rev Grw (000s) (0
2007 A 154.2$ (5,146.8)$ (0.11)$ nm nm Cash & Cash Equivs $659.8 Working Capital ($5,78
2008 A 65.7$ (5,414.0)$ (0.05)$ nm nm Cash/Share $0.01 Current Ratio
2009 A 29.7$ 929.2$ 0.01$ 21.6x nm Equity (book value) ($15,733.3) Total Debt/Equity
2010 E 174.9$ (7,251.3)$ (0.04)$ nm nm Equity/Share ($0.12) Total Debt/Capital
Source: Company reports, Stonegate estimates
Condensed Income Statements (000s) Condensed Balance Sheet (10/31/09)
See Important Disclosures and Disclaimer on Page 20
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Investment Factors
Advaxis, Inc. is a development-stage biotechnology company that develops proprietaryListeriamonocytogenes-based cancer vaccines. Below we outline important investment points toconsider for Advaxis.
Investment PositivesNovel immunological treatment for cancer acts as a differentiator - At the core of Advaxisproduct portfolio is its patented delivery system that uses attenuated, live Listeriamonocytogenes (Lm) as its vector to deliver the antigen fusion protein Listeriolysin-O (LLO),which elicits a powerful and comprehensive immunological response. We note that theimmunological response comes from both the innate and adaptive tiers. Furthermore, and moreimportantly, Advaxis vaccine elicits an intratumoral affect, which inhibits the regulatory T-cells that are acting to hide cancerous cells. Consequently, the bodys immune system finallysees the cancer and begins to attack it, thus enabling a more successful remission. This laststep is where many immunological vaccines have failed in the past.
Strong IP portfolio Advaxis has 27 issued and 45 pending patents covering multiplecompositions of matter, methods and uses for live Listeria-based vaccines. Advaxis is the
exclusive licensee of these patents based on the work of Dr. Yvonne Paterson at the Universityof Pennsylvania, and the Company has the rights to an extensive portfolio of intellectualproperty, filed both in the U.S. and internationally, pertaining to the use ofListeria and listerialproducts used as vaccine vehicles. Lastly, we note that Advaxis recently defended one of itskey patents in European Patent Court against a challenge made by Anza Therapeutics, Inc.,formerly Cerus Corp.(NASDAQ: CERS). The patent covers the use of bacteria to deliver anantigen and generate an anti-tumor immune response. Advaxis successfully defended thechallenge, and the ruling cannot be appealed.
Large addressable market targeted Currently, cancer is the second leading cause of deathby illness in the U.S. The National Cancer Institute expects cancer to take the lead position inthe U.S. within five years. Advaxis is initially targeting cervical cancer by using its unique
immunological treatment. BCC Research estimates that the global market for immunotherapieswill reach $37.2 billion by 2012, and within that market, the sector with the greatest potentialfor growth is cancer vaccines.
Recent financings provide capital September 2009, Advaxis signed an equity line of creditfor a maximum of $5M until September 2012. In January 2010, the Company drew downapproximately $1.45M, which leaves approximately $3.5M of the line remaining. TheCompany also issued about $670K in junior unsecured convertible notes
New clinical trial commencements imminent 3 clinical trials that advance Advaxisoriginal Phase I trial should start this year. Its Phase II trial for CIN and Cervical Cancer(India) are expected to commence in one month and 4-5 weeks from today, respectively, while
its UK Head and neck cancer Phase I/II trial is expected to commence in Q3/Q4.
Investment ChallengesShareholder dilution With no reported revenues, Advaxis is highly dependent on raisingcapital. Furthermore, the Company can not start/complete its Phase II clinical trials until itacquires adequate capital. Lastly, many of the recent financings contain anti-dilutionprovisions and some debt are convertible into equity. The Company currently has 127.2Mshares outstanding, 18.3M options, 99.5M warrants, and potentially an additionally 49.7Mshares to issue from convertible debt (all shares are as of October 31, 2010 except for warrants,which are as of February 2010). Coupled with a dependence on capital to continue operations,current shareholders could be diluted.
STONEGATE S E C U R I T I E S 2
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Going concern opinion expressed by auditors and internal controls weakness Since itsinception, Advaxis has not generated significant revenues and consequently has sufferedsignificant net losses. As of October 31, 2009, Advaxis reported an accumulated deficit of$16.6M, and negative working capital of $5.8M. Additionally, as of October 31, 2009,Advaxis auditors continue to express a going concern opinion and Company management hasindicated that its internal controls are ineffective.
Attraction of institutional investor capital may prove difficult Tom Moore, CEO, waspreviously the CEO of Biopure Corporation from July 2002 to February 2004 (Other OTC:BPURQ.PK). During his tenure at Biopure, the SEC alleged that in 2003, he, the head ofregulatory affairs (Howard Richman) and general counsel engaged in misleading publicstatements about the status of negative results received from the FDA in regard to the approvalof its key drug Hemopure. Mr. Moore settled with the SEC in February 2007 and is subjectedto a five year injunction from violating antifraud provisions of the federal securities laws andpaid a fine. Importantly, Mr. Moore has stated that he relied on Mr. Richman and was thus alsomisled. Given Mr. Richmans actions since the events at Biopure, Mr. Moores statementappears credible. We note that Mr. Richman was permanently barred from serving as an officerof a publicly traded company and paid a fine. Moreover, in March 2009, Mr. Richman pleadedguilty to an obstruction of justice charge for pretending he had terminal cancer and admitted to
impersonating his own doctor to avoid the federal lawsuit filed by federal regulators mentionedabove. While Mr. Richmans actions lend credibility to Mr. Moores statement, institutionalinvestors may nonetheless be hesitant to commit investment capital to Advaxis. Despite thisopinion, we would note that the Company recently raised a maximum of $5M from OptimusCapital LLC via an equity line of credit.
Rigorous FDA evaluation and approval process Pharmaceutical approvals in the U.S. arestringent and typically unpredictable. Whats more, the clinical trial process is lengthy,expensive, and often fails at various stages. Recent FDA data show evidence of increasedfailure rates with a current 8% probability of a new drug entering Phase I development and itsability to make it to registration versus a historical 14% probability. Furthermore, the FDAmay require additional testing after successful completion of clinical trials if some required
regulatory criteria are not met. Even if the FDA grants approval, the approval may includelimits on indication uses.
IP portfolio is dependent on its licensing agreement with the University of Pennsylvania Advaxis technology is based on over 20 years of research by Dr. Yvonne Paterson, Professorof Microbiology at the University of Pennsylvania and Chairperson of the Advaxis ScientificAdvisory Board. Advaxis has been in negotiations since March 2007 over an option toapproximately 35 additional patents. This option period expired June 2009. While theCompany continues its negotiations, any failure to acquire the license to use the additional IPwould materially and adversely affect the Companys patent position.
High level of competition may render Advaxis technology obsolete The biotechnology
and biopharmaceutical industries are characterized by rapidly changing markets, technologies,regulatory standards, and frequent new product introductions. Consequently, changes to any ofthe above factors may render Advaxis products obsolete, less competitive or less marketable.
News flow dependent Because Advaxis is an early stage drug development company with noreported revenues, traditional financial analysis is less relevant. Consequently, we believe, ingeneral, that companies operating in the realm of this investment landscape are highlydependent on new flow rather than traditional financial measurement yardsticks. Hence, ifnews flow slows down or is not forthcoming, the stock price could drift lower. Additionally,due to current stock market conditions, investors could avoid these types of investmentscausing Advaxis stock to decline.
STONEGATE S E C U R I T I E S 3
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Valuation Summary
Advaxis is a development-stage biotechnology company with a novel immunological cancervaccine. At the core of Advaxis product portfolio is its patented delivery system that usesattenuated, liveListeria monocytogenes (Lm) as its vector to deliver the antigen fusion proteinListeriolysin-O (LLO), which elicits a powerful and comprehensive immunological response.
The vaccine has the following affects: An immunological response from both the innate and adaptive tiers An increase in cytotoxic T-cells in tumor A decrease in regulatory T-cells in tumor Consistently breaking of antigen tolerance (inhibitory Tregs) Delivers immediate therapeutic effects Promotes prolonged immunity Sensitive to antibiotics
Additionally, it is a stable vaccine that may be stored frozen; can be grown on completely synthetic
media and
can change the antigen to target any type of cancer or infectious diseaseWhile an approved FDA product is not imminent, the target market opportunity is significant.According to BCC Research, the estimated global market for immunotherapies will reach $37.2billion by 2012, and within that market, the sector with the greatest potential for growth iscancer vaccines.
Our Comparison Table shows the market placing a median enterprise value on cancer biotechfirms of $115.5M vs. Advaxis enterprise value of $27.2M.
We outline potential catalysts for Advaxis over the next two calendar years:
Capital raise(s) ..................................................................................... 2010/2011 Commencement of Phase II trials ......1st half 2010 Definitive licensing agreement ......... 2011 Approval of Fast Track designation .... 2010/2011
STONEGATE S E C U R I T I E S 4
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Company Overview
Company Background
Advaxis, Inc. is a development-stage biotechnology company that is developing proprietaryListeria monocytogenes-basedcancer vaccines. Advaxis technology is based on over 20 yearsof research by Dr. Yvonne Paterson, Professor of Microbiology at the University ofPennsylvania and Chairperson of the Advaxis Scientific Advisory Board. In July 2002,Advaxis signed an exclusive 20-year licensing agreement with University of Pennsylvania thatis subject to royalty and milestone obligations. Advaxis trades on the OTC BB under thesymbol ADXS.
Products and Technology
Advaxis lead vaccine candidate is called ADXS 11-001, which uses a patented delivery systemto target various cancers. The Company is targeting cervical cancer, cervical dysplasia, headand neck, breast, and prostate cancers.
Exhibit 1: Product Candidates
Construct Indication
ADXS11-001 (Phase I) Cervical cancer
ADXS11-001 (Phase II) Cervical dysplasia
ADXS11-001 (Phase II) Cervical cancer
ADXS11-001 (Phase II) Cervical cancer
ADXS11-001 (Phase I/II) Head & neck cancer
ADXS31-164 (Phase I) Breast cancer
ADXS31-142 (Phase I) Prostate cancer - PSA secreting cells
Source: Company Reports, Stonegate Securities
At the core of Advaxis product portfolio is its patented delivery system that uses attenuated,live Listeria monocytogenes (Lm) as its vector to deliver a tumor associated antigen fused(TAA) to the protein Listeriolysin-O (LLO), which elicits a powerful and comprehensiveimmunological response. To best understand Advaxis technology, it is helpful to brieflyreview the human immune system.
Immune System ReviewThe immune system is composed of two tiers of protection against foreign invaders.
Tier 1: Innate immune system is the bodys first line of defense and provides an immediateresponse that is non-specific to a pathogen.
Tier 2: Adaptive immune system is the second line of defense and is supported by the innateresponse. This system is not immediate and requires some time to react. It also is antigenspecific meaning that it reacts only to the foreign invader that induced the response.Importantly, the adaptive system retains this response in its memory and is able to exhibit anincreasingly faster and stronger response to combat the pathogen on subsequent exposure. We
also note that there are two pathways that the adaptive system takes to fight invaders.
GATE S E C U R I T I E S 5STONE
Exhibit 2: Mapping The Immune System
Humoral
(B Cells)
Cell mediated
(T Cells)
Humoral
(B Cells)
Cell mediated
(T Cells)
Anatomical
(i.e. Skin)
Source: Company Reports, National Cancer Inst., Stonegate Securities
Innate Immunity Adaptive Immunity
Immune System
Bacteria Bacteria Virus
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Adaptive immune systemresponse - Class II Pathway(Exogenous)
Exhibit 3: The Body's Immune Response
Source: Company Reports; Stonegate Securities
Antigen-presenting cells (APCs)roam inside the body and searchfor foreign invaders. When theyfind an invader, they eat it,
break it down, and push pieces ofit to its surface that act asmolecular targets for the immunesystem. Here, APCs stimulate T-cells to action by presenting themwith a target.
Adaptive cellular immune system response - Class I Pathway (Endogenous)The other response occurs when a cell begins to produce unusual proteins within itself(cytoplasm to be specific). Similar to some of the exogenous steps above, the unusual proteinsare broken down inside the cell, and pieces of it are pushed to the cell surface. Once again,these pieces act as molecular targets for the immune system and call T-cells to come over and
kill it.
T-cells come in many forms and two important ones are: 1) Helper or 2) Killer (cytotoxic).Helper T-cells (CD4+ T-cells) are the middlemen of the immune system that assist in theimmune response by secreting chemicals that enable Killer T-cells to battle. Killer T-cells (alsoknown as cytotoxic T-cells or CD8+ T-cells) destroy infected cells. The destruction of theinfected cells occurs when killer T-cells (CD8+) release cytotoxins that form pores in theforeign cells plasma membrane, enabling granzymes to activate a series of enzymes that leadto the death of the infected cell.
Why use Listeria?Central to the Companys technology is the microbe Listeria monocytogenes. Listeria is a
well-known bacterium in the medical community. It is a pathogen that causes food poising insomeone whose immune system is compromised or who eats a large quantity of it.Importantly, the body has developed (over hundreds and thousands of years) an immediate andpowerful response should it encounter Listeria. Consequently, Advaxis builds on the verypotent immune response toListeria bacterium.
Advaxis engineers a modified Listeria (attenuated version of wild Listeria) to deliver specificcancer antigens. In turn, the modifiedListeria vaccine enlists the immune system to attack theListeria bacteria and simultaneously educate the immune system to attack specific cancercells. Importantly, Advaxis vaccines trigger the two tiers of the cellular immune systemresponse as described above.
Simply put, when Listeria enters the body it elicits an immediate innate immune response.Then, as the Listeria infects antigen-presenting cells (APCs), these APCs direct the immunesystem to attack theListeria as described in the adaptive immune response. In the ADXS 11-001 vaccine, the bacterium is engineered to secrete fragments of HPV-E7, a molecule found onthe surface of malignant cervical cells. The immune system is then triggered to recognize thesecancer cells and destroy them. This sequence of events has been compared to offering abloodhound the scent of its target. By modifying the Listeria bacteria to carry chemical tagsfound in a specific type of cancer, the body directs the immune system to focus its attack on thecancer.
STONEGATE S E C U R I T I E S 6
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How does Advaxis vaccine work?Below in Exhibit 4, we illustrate how Advaxis Listeria vaccine is bioengineered and its mainmechanism of action.
STONEGATE S E C U R I T I E S 7
Exhibit 4: Mechanism of Action
STEP 1: THE
CARRIER
Delivery Vector
An attenuated, bioengineeredLm bacterium is
selected as the delivery vector. The bacterium
is attenuated by a factor of 10,000 to 100,000times so it doesn't offer a health risk, but offers
the strong immunicity of a wild Listeria
STEP 2: THE
GENETIC
SEQUENCING
Antigen/Adjuvant
Fusing
A genetic sequence is engineered becoming
the template for a tumor specific antigen
(tumor target). It will be fused to a modified
Lm protein, Listeriolysin-O (LLO) that allows
the bacterium to synthesize and secrete the
active antigen/adjuvant within the target cells
STEP 3: THE
BIOENGINEERING
Plasmids Created and
Inserted
A plasmid containing Advaxis bioengineered
genetic information is created. The antigens
that are currently in Advaxis vaccines are E7
(targets cervical cancer), Her-2 (targets breast
cancer) and PSA (targets prostate cancer)
STEP 4: THE
FACTORY
Advaxis Trojan Horse
The bioengineered plasmids are then inserted
into the livingLm delivery vector system.
These organisms become small biological
factories
Acting as a Trojan Horse, the finished product
is an immunotherapeutic technology that
makes the active drug and secretes it where itis used within the cells
THE ADVAXIS Lm
VACCINE EFFECT
Class I and II Cellular
Immunity
After antigen presenting cells (APC) ingest an
Advaxis bioengineeredLm bacterium, it is
broken down into molecular fragments to be
directed and used as an immune attack target
Pathogens are digested in the phagosomes and
the fragments are used to stimulate Class II
cellular immunity (the exogenous pathway)against the Advaxis bioengineeredLm
bacterium
The Advaxis bioengineeredLm bacterium will
perforate the phagosome membrane, escape
into the cytosol and stimulate Class I cellular
immunity (the endogenous pathway)
Source: Company Reports; Stonegate Securities
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The intratumoral affectA very unique and important finding of Advaxis vaccine is its ability to alter the tumormicroenvironment. By definition, cancer tumors are cells that have managed to evade theimmune system. It has been discovered that, in essence, cancer cells have hijacked parts ofthe immune system that help protect the body by aiding the immune system in distinguishingbetween self (body) and non-self (foreign invader). Specifically, another type of T cell,Regulatory T-cells (called Tregs) are what inhibit the anticancer response.
AdvaxisListeria vaccines secrete LLO-antigen fusions that reduce intratumoral regulatory T-cells (Tregs) and alter the tumor microenvironment in constructive ways that are unlike anyother vaccine vector. Consequently, the immune system is awakened and sees the oncehidden cancer cells. Furthermore, this action enables the bodys immune system to attack anyfuture growth of the specific cancer and leads to a more successful remission. This last step iswhere many immunological vaccines have failed in the past.
Exhibit 5 illustrates the results from a study that compares two vaccines - one that includes theLLO fusion protein (ADXS11-001), andone that does not. The inclusion of LLOin the vaccine increased the cytotoxic
(tumor killing) T-cell activation by 400%and decreased the inhibitory T-cells by80%.
Exhibit 5: Intratumoral Affect
Vaccine
Activated Tumor
Killing T-Cells (In
the tumor)
Inhibitory T-cells
(in the tumor)
Lm-E7 (- LLO) 9.40% 11.80%
ADXS11-001 (+LLO) 36.80% 1.70%
Source: Company Reports; Stonegate SecuritiesOther effectsAdditionally,Listeria stimulates other non-classical mechanisms that act to support the overallimmune response described above. These include: the stimulation of bone marrow to makemore immune cells, the stimulation of blood vessel cells that allow activated immune cells toleave the blood and enter tumors, and other supportive effects.
Listeria made safeAs mentioned, Listeria is known to cause food poisoning and is responsible for, on average,
500 deaths a year in the U.S. Advaxis addresses the safety issue in several ways. First, aspreviously mentioned, Advaxis attenuates itsListeria by a factor of 10,000 to 100,000. Second,Advaxis also performs skin tests on each of the participants in its trials to insure an adequateimmune response before the vaccine is injected. And lastly, following each does, eachparticipant is given a regimen of antibiotics, which kills the remaining bacteria, but has noapparent effect on the memory response that is retained by the immune system.
Advantages of AdvaxisListeria delivery vector vaccinesAdvaxis therapeutic approach differs from other immunotherapies that simply introduce anantigen into the immune system to trigger a response. Below we list why Advaxis vaccine ispotentially more effective versus other solutions:
Listeria has a strong stimulating effect on the innate immune system, which sets thestage for a strong adaptive immune response against a specific target
Listera infects the immune system and tells it what to attack and can thus efficientlydirect an immune response to attack any type of cancer or infectious disease base onwhatever antigen is bioengineered into a vaccine.
The adaptive immune response is triggered via secreted antigens into the cytosol ofAPCs, which quickly activates T-cells and tells them what to attack
Consistently breaks antigen tolerance (inhibitory Tregs) Promotes prolonged immunity (immune memory) In pre-clinical research, Advaxis Listeria technology has consistently demonstrated
complete therapeutic responses that result in complete tumor regression Sensitive to antibiotics Stable vaccine that may be stored frozen; can be grown on completely synthetic media
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Intellectual Property
As the exclusive licensee of patents based on the work of Dr. Yvonne Paterson at theUniversity of Pennsylvania, Advaxis has rights to an extensive portfolio of IP, filed both in theU.S. and internationally, pertaining to the use ofListeria and listerial products used as vaccinevehicles. The Advaxis patent portfolio consists of 27 issued patents and 45 pending and in-process patents covering multiple compositions of matter, methods and uses for live Listeria-based vaccines. The patents cover four differentListeria species and two different families ofadjuvant fusions. The patents are filed in the U.S., Japan, Canada, Australia and Europe.
Advaxis works with its patent counsel to surround its product and technology platform withsignificant offensive and defensive patent protection. The Company recently defended one ofits key patents in European Patent Court against a challenge made by Anza Therapeutics, Inc.,formerly Cerus Corp.(NASDAQ: CERS). The patent covers the use of bacteria to deliver anantigen and generate an anti-tumor immune response. Advaxis successfully defended thechallenge, and the ruling cannot be appealed.
Business Strategy
Advaxis business strategy is focused on developing sufficient human clinical data to
demonstrate its effectiveness in combating cancer. Given its early stage business lifecycle, itsbusiness plan has been executed by largely outsourcing virtually all of its major functions.These include: drug development, manufacturing, R&D, grant applications, and clinical studiesamong others. Additionally, the Company is focused on attaining partners to help it conduct itsclinical trials as evidenced by The Cancer Research UK Phase I/II trial, and its GOG/NCI trials.
Longer-term, Advaxis envisions licensing its technology for commercial development. TheCompany does not intend to engage in commercial development beyond Phase II clinical trialswithout partnerships or license agreements.
Financial Model Review
Given the development stage of Advaxis, a clear financial model is not currently defined.
Needless to say, the Company is highly dependent on financing to continue its operations.
STONEGATE S E C U R I T I E S 9
Exhibit 6: Capital Structure
Total Shares Outstanding (000) - as of 2/16/2010 127,201.2
Notes Payable (convertible) - June 09 Bridge 296.5$ Notes Payable - BioAdvanced 50.0$
12% interest rate; mature Dec 09; Security interest 8% interest rate; matured June 09; lender has
granted in all tangible & intangible assets; 2.5 warrants extended payment until draw down of equity LC
issued per $1 invested - strike @ $0.20, mature 5 yrs;
NP convrt into common or new securities @ a discount Series A Prfd Stock - Equity line of credit 1,450.0$
- conversion & discount dependent on new financing Definitive agreement signed Sept-09; max $5M; draw in
with different timeframes one or more tranches until Sept-12; 10% int rate payable
in Series A Prfd stk; non-convertible; redeemable by
Notes Payable (convertible)- Oct 09 Bridge Company after 5yrs - 33.75M 3yr warrants issued, strike @
Oct 26 and Oct 30 issue dates; mature 4/30/2010; 2.5 2,147.1$ $0.17; warrant exercise proceeds payable in 4yr note @ 2%warrants issued for every $1 invested strike @ $0.17;
NP conv't with similar terms/conditions as Jun 09 bridge Warrants 9
Vast majority of warrant strike prices now @ $0.17; 54.6M
Junior Unsecured Notes Payable (convertible) 673.5$ warrants ('07 PIPE) strike w/ full ratchet anti-dilution trigged
Issued btwn Nov-09 & Feb-10; mature btwn 4/16/10 & if offering below $0.20;
7/30/2010; no repmt made until Jun-09 bridge paid-off;
1.4M warrants strike @ $0.17
Stock Options 1
Notes Payable - CEO 948.0$ Wtd avg price @ $0.16; wtd avg life @ 6 yrs
12% interest rate; matures Jan 2010; warrants
issued on 3-3 basis of $ invested in NP; CEO took Other items
subordinated position vs. bridge financing note; with Pmt to U Penn for addt'l IP; there are also various other 548.1$
accrued interest debt @ ~$1M royalty/fees & milestone pmts due upon commercialization
ource: Company reports, Stonegate Securities
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As of October 2009, Advaxis projects its subsequent annual operating expenses and preclinicalexpenses at approximately $4.1M. Its cost of its Phase II trials for CIN, late stage cervicalcancer and Head and Neck cancer (see Pipeline section below), are estimated at approximately$8M over the 30 month trial period. With current cash at about $2.0M-$2.6M ($660K [cash asof October 30th 10K] + $1.45M from Series A preferred equity LC draw down [January 2010]+ $670K from junior unsecured convertible debt), Advaxis needs to raise capital.
Recent results/whats newAdvaxis reported financial results for its Q4 and fiscal year end. Revenues of about $35,000were recognized from a draw down of its NIH grant. Furthermore, the Company recognized aprofit for P&L purposes but we note that the profit was due to a non-cash adjustment to theliability value of its warrants on its balance sheet. Furthermore, the Company raised about$1.8M in the quarter and raised an additional $2M (approximately) after the quarter end via theissue of junior unsecured convertible promissory notes and an equity line of credit.
Earnings Model AssumptionsWe modeled $175,000 in revenues for FY10, which represents the remaining draw down of theNIH grant (awarded in Q4FY09). We model operating expenses of $7.1M for FY10. OurFY10 expenses are based on a monthly cash burn of approximately $255,000 plus incremental
monthly expenses for clinical trials commencing (CIN, India trial and Head and neck; seePipeline section, below). We also assume that Advaxis raises an additional $8M via a commonequity offering (exclusive of Equity LC which we assume is used to repay existing bridgeloans), which drives our FY10 share count.
Pipeline
Advaxis is targeting multiple clinical trials targeting CIN and several HPV-related cancers.Below we illustrate the Companys programs. We note that the CIN, Cervical Cancer(GOG/NCI), Cervical Cancer (India) and Head and Neck Cancer are trials that are building onAdvaxis 2007 completed Phase I trial (first one listed below).
Exhibit 7: Clinical Trial ProgramProduct
Name Indication
Cancer
Stage Sponsor
Pre-
Clinical
Phase
I
Phase
II
Phase
III
ADXS11 -001 Cervical cancer Late Advaxis
ADXS11 -001 Cervical dysplasia (CIN) Early Advaxis
ADXS11 -001 Cervical cancer Late GOG/NCI
ADXS11 -001 Cervical cancer Late India
ADXS11 -001 Head & neck cancer Late CRUK
ADXS31 -164 Breast cancer Late US
ADXS31 -142 Prostate cancer Late Advaxis
Source: Company Reports, Stonegate Securities
Pre-clinical resultsIn pre-clinical studies involving animals that have been injected with cancer cells to generate a5mm tumor, results showed that administering different Lm vaccines in many cancer modelsled to complete tumor clearing of pre-existing tumors in approximately 75% of the animals.The pre-clinical trial demonstrated:
100% tumor clearance of pre-existing tumors in 50% to 100% of normal animalsthrough use of differentLm vaccines in many cancer models.
25% to 50% tumor clearance in transgenic animals, which tend to be the most difficultto treat.
In the animals that had a favorable response to the vaccine, re-inoculated tumor cellswould not grow even after waiting several months, indicating long-term immunity.
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The results are also impressive when compared with other live vaccines in an independentanimal trial. The National Cooperative Drug Discovery Group at the National Cancer Instituteasked several labs to provide their most effective cancer vaccine to participate in a comparisontest. As indicated in Exhibit 8, ADXS 11-001 outperformed the participants that includedVaccinia, DNA and peptide vaccines.
Exhibit 8: NCI Tumor Vaccine Test
Vaccine
ADXS11-001
LmE7
Vac-SigE7
Vac E7
E7-DNA
E7-DNA in SBAS2
Db peptide in SBAS2
Source: Company Reports, Stonegate Securities
0
0
0
0
% Tumor Free Mice
50 - 100
0
0 - 25
Phase I ADXS11-001 cervical cancer trialIn October 2007, Advaxis concluded its first human clinical trial using live attenuated Lmvaccine (ADXS 11-001). The clinical trial included 15 patients with progressive, recurrent,
metastatic squamous cell carcinoma of the cervix who had failed to respond to chemotherapy,radiotherapy and/or surgery. The participants were divided in three cohorts of five patients:Cohort I - 1 x 109 , Cohort II - 3.3 x 109 and Cohort III - 1 x 1010 . Each of the cohorts receivedtwo infusions of ADXS 11-001 that were administered 21 days apart. Each of the doses wasfollowed after five days with a regimen of ampicillin. Follow up visits were at three weeks andthree months following the second dose.
Toxicity was limited to flu-like symptoms comprised of fever, chills and nausea. Higher feverand hypotension occurred in Cohort III; however, the patients side effects, including thehypotension, promptly responded to symptomatic treatment withnon-prescription non-steroidalanti-inflammatory drugs (NSAIDs) and anti-emetics without the need for early antibiotics.
Although the trial was not designed to evaluate efficacy, RECIST criteria survival data from 13eligible patients were analyzed. The overall median survival for patients in the Advaxis trialwas 347 days, and over two years for two patients who are alive at the time of this writing.This is particularly noteworthy given that the survival of patients in the metastatic, refractory orrecurrent ICC is only three to six months. Additionally, we note that 4 of 13 (30%) evaluablepatients experienced tumor reduction.
Exhibit 9: Survival - ADXS11-001 vs. GOG Historical Data
12-Month
Survival
(%)
Median
Survival
(Days)
Still Alive
(Days)
GOG Standard 5 180 NA
ADXS11-001 Phase I
Clinical Trial
53 347 1,000+
Source: Gynecologic Oncology Group (GOG), Advaxis, Inc., Stonegate Securities
Exhibit 10: ADXS11-001 Phase 1 Efficacy Trial Study
# Patients Percent
Tumor progression 5 38.5%
Tumor stablization 7 53.8%
Tumor reduction 4 30.7%
Unconfirmed partial tumor response 1 7.7%
Source: Company Reports, Stonegate Securities
STONEGATE S E C U R I T I E S 11
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Other vaccines in the Advaxis pipelineAdvaxis technology can bioengineer dual antigen systems that have the capability of attackingtwo different cancer targets using a single vaccine. Recently, Advaxis announced the Companyis a recipient of a $210,000 grant from the U.S. National Institutes of Health (NIH) to develop asingle Lm vaccine that delivers two different antigen-adjuvant proteins to attack two separateand distinct tumor targets. Further research isfocused on a dual delivery system using a tumor
cell surface marker to kill tumor attack tumorcells, combined with anti-angiogenesis to impaira tumors ability to grow by reducing its bloodsupply.
Exhibit 11: Other Vaccines in the Pipeline
Antigen IndicationHWM-MAA Anti-angiogenesis, melanoma
p53 Many types of cancer
WT-1 Lymphomas; leukemias
PSCA Prostate cancer
Telomerase Many types of cancer
Survivin Ovarian cancer
Source: Company Reports, Stonegate Securities
In Exhibit 15 (see appendix on page 15), weprovide an estimated timeline as it relates toAdvaxis clinical trials.
Industry Overview
Industry Background
The goal of immunology research is to develop methods that exploit the natural tendency of thehuman body to defend itself against disease. Researchers once believed that the immunesystem was limited to combating infectious diseases caused by bacteria and viruses; however,years of research have created some successful examples of immunotherapies for cancer. Thelaunches of Merck (NYSE: MRK) and Sanofi Pasteur MSD's Gardasil (FDA approved in2006) and GlaxoSmithKlines (NYSE: GSK) Cervarix (approved in EU in 2007) havesignificantly boosted clinical interest in cancer vaccines. BCC Research estimates that theglobal market for immunotherapies will reach $37.2 billion by 2012, and within that market,the sector with the greatest potential for growth is cancer vaccines.
The cancer vaccine market consists of two types of vaccines:
Prophylactic cancer vaccines - designed to prevent the development of cancer; given tohealthy subjects to prevent infection with cancer-causing viruses
Therapeutic cancer vaccines - designed to treat existing cancers; given to cancerpatients to stimulate the immune system into recognizing and attacking existing cancer
Prophylactic vaccines (Gardasil and Cervarix) control the cancer vaccine sector, andresearch firm Espicom Business Intelligence expects that portion of the market to reach $4billion by 2011. While there are currently no sales in the therapeutic market (where Advaxis ispositioned), Espicom is optimistic regarding the potential of that market, forecasting sales toreach $5 billion by 2012. The optimism is largely predicated on the recent changes in thelandscape of the therapeutic cancer vaccine market, which is shifting from a product pipelinefilled with vaccines in Phase I and II stages, to a more mature pipeline with multiple productsin Phase III trials (see Exhibit 14 on page 14). The Phase III candidates are targeting highprofile cancers, including melanoma, prostate, non-small lung, renal cell, and colorectalcancers.
Current target marketsCurrently, cancer is the second leading cause of death by illness in the U.S. The NationalCancer Institute expects cancer to take the lead position in the U.S. within five years. TheNational Institutes of Health estimates overall costs of cancer in 2007 at $219.2B, of which$89B is in direct medical costs, $18.2M in costs due to lost productivity, and $112M in costsdue to lost productivity from premature death.
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Because cancer disproportionately strikes older people, demographic trends present a strongpush for long-term growth. In the U.S., the Census Bureau estimates that there are about 303Mpeople. Of this, approximately 13% is aged 65+ with expansion to about 20% in 2030. In2006, people over 65 accounted for over one-third of the U.S.s total consumption ofprescription medicines. Additionally, world population stands at about 6.6B with projectionsby the United Nations to reach 9.1B in 2050. The percentage of people aged 60+ will increasefrom 11% in 2006 to 22% in 2050. The prediction for Europeans aged 60+ is to move from
21% of the population in 2006 to 34% by 2050, and developing countries forecast is to movefrom 8% in 2006 to 20% in 2050.
Exhibit 12: Demographics As A Driver
Source: US Census Bureau, United Nations, Stonegate Securities
0%20%40%60%80%
100%
2006 2030
US
Age
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STONEGATE S E C U
Exhibit 14: Therapeutic Cancer Vaccines in Late-Stage Clinical Trials
Antigenics, Inc
(AGEN)
Oncophage approved in Russia;
QS-21 in Phase III trials for
treatment of melanoma and non-
small cell lung cancer
Antigenics' patient-specific cancer vaccine, Oncophage is currently approved in Russia for the
adjuvant treatment of kidney cancer patients. In October 2008, Antigenics submitted a marketing
authorization application to the European Medicines Agency (EMEA) requesting conditional
approval for Oncophage in earlier-stage, localized renal cell carcinoma. Antigenics QS-21 is an
immune adjuvant in Phase III trials including non-small cell lung cancer, melanoma and malaria
Biovest International
(BVTI.OB)
Phase III trials for treatment of non-
Hodgkin's lymphoma
Biovest International develops personalized immunotherapies for cancers of the blood system.
Biovest is the holder of a Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute for the commercialization of BiovaxID, a personalized biologic
therapeutic cancer vaccine for the treatment of non-Hodgkins lymphoma. This therapy, referred to
as BiovaxID, is currently in a phase III pivotal trial at 24 major medical institutions in the US.
GenVec(GNVC) Phase III trials for advancedpancreatic cancer
GenVecs lead product, TNFerade, is currently in a pivotal, Phase III clinical study (PACT) in
locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for it
potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer,
and head and neck cancer.
Dendreon
(DNDN)
Two Phase III trials completed
targeting advanced prostate cancer
Provenge, which is used to fight advanced prostate cancer, will possibly become America's first
approved cancer vaccine either later this year or sometime in 2010. The FDA has stated that
Provenge would be approved if the vaccine met survivability endpoints in the recently completed
IMPACT trial. Results from an integrated analysis of two Phase III studies of PROVENGE, D990
and D9902A, demonstrated a survival advantage for patients randomized to PROVENGE versus
those randomized to placebo.
Onconthyreon's
(ONTY)
Phase IIb trials for advanced non-
small cell lung cancer and Phase III
trials for non-small cell lung cancer
and breast cancer
Onconthyreon just announced positive results of a study involving patients who received treatment
with the cancer vaccine, Stimuvax, for between 2 and 8.2 years as part of the Phase IIb trial in
patients with stage IIIb/IV non-small cell lung cancer. Merck KGaA is responsible for the world-
wide development and commercialization of Stimuvax under license from Oncothyreon and is
currently conducting Phase III trials of Stimuvax in both NSCLC and breast cancer.
Source: Company Reports, Stonegate Securities
R I T I E S 14
Additionally, many head and neck cancers are also related to the human papilloma virus. TheAmerican Academy of Otolaryngology estimates that 55,000 people in the U.S. will developsome form of head and neck cancer in 2009. An estimated 25% of head and neck cancersexpress HPV antigens. Studies suggest that HPV may also play a role in cancers of multipleareas of the body including the lung, prostate and other areas.
Competition
The biotechnology and biopharmaceutical industries are characterized by intense competition,rapid technological change and a high degree of uncertainty. Furthermore, the industry is fairlyfragmented with various sized companies attempting to develop and commercialize newtreatments for cancer. Although therapeutic vaccines have shown great promise in clinicaltrials, these results have not yet translated into approved therapies. Therapeutic cancer vaccinecompanies are using a variety of vectors that have very different mechanisms of action. Theadvantages ofListeria monocytogenes over other vectors are listed on page eight.
Exhibit 14 lists several immunotherapy companies with therapeutic cancer vaccines that are inlate-stage trials. We note that none of these companies employsListeria as a delivery vector.
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Appendix
Exhibit 15: Clinical Trial Estimated Timeline
Product
Candidate Indication (Sponsor) 2010 2011 2012 2013 2014 2015
ADXS11-001 CIN (Advaxis) (1) (2)
Patients (80); Estcost ($5.7M-$6.0M)
ADXS11-001 Cervical cancer
(GOG/NCI) (1) (2)
Patients (63); Est
cost ($2.5M-$3.0M)
ADXS11-001 Cervical cancer (India)(1) (2)
Patients (110); Est
cost ($2.1M-$2.3M)
ADXS11-001 Head & neck cancer
(CRUK) (2) (3)Patients (~45); Est
cost ($0.5M; $2.5M-
$3.0M funding from
CRUK)
ADXS31-164 Breast cancer (DOD) (2)
Patients (TBD); Est
cost ($3.0M-$3.5M)
ADXS31-142 Prostate cancer
(Advaxis) (2)Patients (TBD); Est
cost ($3.0M - $3.5M)(1) These trials are using clinical data derived from the 2007 completed Phase I cervical cancer trail
(2) Subject to financing
(3) CRUK is the Cancer Research UK; announced February 2010
Source: Company Reports, Stonegate Securities estimates based on Company input and FDA averages
Phase II Phase III
Phase II Phase III
Phase I Phase II P
Phase I Phase II
Phase I/II Phase III
Phase II Phase III
STONEGATE S E CUR I T I E S 15
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GATE S E CUR I T I E S 16
Comparison Table
Exhibit 16: Comparative AnalysisAdvaxis Inc (OTCBB: ADXS)
(all figures in $M expect per share information)
Name Ticker Price (1) Sh Mrkt Cap EV
Cancer VaccinesDendreon Corp DNDN 35.30$ 134.1 4,735.1$ 4,054.2$
GenVec Inc GNVC 2.91$ 106.3 309.4$ 283.5$
Oncothyreon Inc ONTY 4.95$ 25.7 127.0$ 89.2$
Biovest International Inc BVTI 1.22$ 96.5 117.7$ 141.8$
Antigenics, Inc AGEN 0.76$ 89.7 68.2$ 82.3$
Hi 4,735.1$ 4,054.2$Low 68.2$ 82.3$
Average 1,071.5$ 930.2$
Median 127.0$ 141.8$
Other Cancer
Seattle Genertics, Inc SGEN 11.78$ 100.5 1,184.2$ 839.2$
Allos Therapeutics, Inc ALTH 7.33$ 103.9 761.9$ 655.2$
Infinity Pharmaceuticals, Inc INFI 6.28$ 26.2 164.5$ 31.7$Idera Pharmaceuticals, Inc IDRA 5.00$ 23.47 117.4$ 71.4$
Sunesis Pharmaceuticals Inc SNSS 0.86$ 34.42 29.5$ 26.1$
Hi 1,184.2$ 839.2$Low 29.5$ 26.1$
Average 451.5$ 324.7$Median 164.5$ 71.4$
Universe:
Hi 4,735.1$ 4,054.2$
Low 29.5$ 26.1$
Average 761.5$ 627.5$
Median 145.8$ 115.5$
Advaxis Inc. (2) ADXS 0.18$ 127.2 22.3$ 27.2$
(1) Previous day's closing price
(2) ADXS' EV calculated using face value of debt outstanding and preferred stock value
Source: Company reports, CapitalIQ, Stonegate Securities
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STONEGATE S E C U R I T I E S
Balance Sheets
Advaxis Inc (OTCBB: ADXS)
Consolidated Balance Sheets (in thousands $)
Fiscal Year: October
2007 2008 2009
ASSETS
Current Assets
Cash & cash equivalents $4,042.0 $59.7 $659.8
Prepaid expenses 199.9 38.9 36.4
Total Current Assets 4,241.9 98.6 696.3
Property and equipment, net 116.4 91.1 54.5
Intangible assets, net 1,098.1 1,137.4 1,371.6
Deferred costs - - 288.5
Other assets 3.9 3.9 303.4
Total Assets $5,460.4 $1,331.0 $2,714.3
LIABILITIES AND STOCKHOLDERS' EQUITYCurrent Liabilities
Accounts payable $787.3 $998.9 $2,368.7
Accrued expenses 305.0 603.3 917.3
Convertible bridge notes & FV of derivative - - 2,078.9
Notes payable & interest payable 80.4 563.3 1,121.1
Total Current Liabilities 1,172.7 2,165.5 6,485.9
Long-Term Liabilities
Notes payable 19.6 4.8
Common stock warrants - - 11,961.7
Total Long-Term Liabilities 19.6 4.8 11,961.7
Stockholders' Equity
Issued shares 108.0 109.3 115.6
Additional paid-in capital 16,276.6 16,584.4 754.8
Accumulated deficit (12,116.6) (17,533.0) (16,603.8)
Total Stockholders' Equity (deficit) 4,268.0 (839.3) (15,733.3)
Total Liabilities and Stockholders' Equity $5,460.4 $1,331.0 $2,714.3
Ratios
Liquidity
Current Ratio 3.6x 0.0x 0.1x
Quick Ratio 3.4x 0.0x 0.1x
Working Capital $3,069.2 ($2,066.9) ($5,789.6)
Leverage
Debt To Equity 2.3% nm nm
Debt To Capital 2.3% nm nm
Capital Usage -Annualized
A/R Turns nm nm nm
Inv Turns nm nm nm
A/P Turns nm nm nm
Source: Company Reports, Stonegate Securities
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Cash Flows
Advaxis Inc (OTCBB: ADXS)
Consolidated Statements of Cash Flows
Fiscal Year: October
2007 2008 2009
Cash Flow from Operations
Net income (loss) (2,454.5) (5,416.4) 929.2
Adjustments to reconcile net income to net cash :
Depreciation of property and equipment 31.5 36.1 36.6
Amortization of expense of intangibles 54.6 161.2 74.5
Amortization of deferred financing costs 177.7 - 61.5
Amortization of discount on bridge loans - - 123.8
Non-cash charges to consultants 786.7 355.4 571.5
Gain on note retirement (1,532.5) -
Accrued interest on note payable - -
Value of penalty shares issued - 31.8
Non cash interest charge 280.1 7.9 698.7
Other assets 0.7 -
Gain/loss on change in value of warrants (1,159.8) - (5,845.2)
Changes in operating assets and liabilities:Accounts payable 99.1 211.6 1,421.8
Deferred revenue (20.4) - -
Accrued expenses (217.4) 298.3 (109.5)
Prepaid expenses (161.8) 161.1 2.4
Deferred expenses - - -
Interest payable (118.0) - -
Impairments of intangible assets - - -
Net cash provided by operating activities ($4,234.0) ($4,153.1) ($2,034.6)
Cash Flow from Investing
Purchase of property and equipment (37.6) (10.8) -
Cash paid for acquisition - - -
Costs of intangible assets (358.3) (200.5) (308.7)Net cash used by investing activities ($396.0) ($211.3) ($308.7)
Cash Flow from Financing
Net proceeds (payments) on convertible debt (2,040.0) - -
Net proceeds (payments) on notes payable 507.9 460.2 3,243.0
Proceeds from issuance of common stock 7,442.9 (78.0) -
Cash paid for deferred financing costs - - (299.5)
Net cash provided (used) by financing activities $5,910.8 $382.2 $2,943.5
Net increase (decrease) in cash 1,280.8 (3,982.2) 600.1
Cash and cash equivalents, beginning of year 2,761.2 4,042.0 59.7
Cash and cash equivalents, end of period 4,042.0 59.7 659.8
Source: Company Reports, Stonegate Securities
STONEGATE S E C U R I T I E S 19
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Important Disclosures and Disclaimer
(a) Stonegate Securities, Inc. (Stonegate) expects to receive or intends to seek compensation forinvestment banking or other business relationships with the covered companies mentioned in thisreport in the next three months.
(b) The Research Analyst principally responsible for the preparation of this report has received compensation thatis based upon, among other things, Stonegates investment banking revenues.
(c)
Within the last twelve months, Stonegate has received compensation for investment banking services fromthe Company and has a non-exclusive placement agency agreement in place as of 6/24/2009; Stonegate isengaged to provide research and institutional investor awareness for the Company. As compensation,Stonegate received compensation of $100,000.
(d) Within the last twelve months, Stonegate has not managed or co-managed a public offering for the Company.(e) Stonegate and/or its employees, officers, directors and owners do not own options, rights or warrants to
purchase this security.(f) Stonegate does not make a market in this security.(g) No employee of Stonegate serves on the Companys Board of Directors.(h) A Research Analyst and/or a member of the Analysts household do not own shares of this security.(i) A Research Analyst and/or a member of the Analysts household do not serve as an officer, director, or
advisory board member of the Company.(j) This security is eligible for sale in one or more states.(k) This security is not subject to the Securities and Exchange Commissions Penny Stock Rules, which may set
forth sales practice requirements for certain low-priced securities.(l) Stonegate or its affiliates do not beneficially own 1% or more of an equity security of the Company.(m)Stonegate does not have other actual, material conflicts of interest in the securities of the Company.Meaning of Ratings - Stonegate does not rate the securities covered in its information memorandums.Distribution of Ratings - Stonegate does not rate the securities covered in its information memorandums.Price Chart - Stonegate does not have, nor has previously had, a rating for any securities of the Company.Price Targets - Stonegate does not have a price target for any securities of the Company.
Regulation Analyst Certification:I, Marco Rodriguez, CFA, hereby certify that all views expressed in this report accurately reflect my personalviews about the subject company or companies and its or their securities. I also certify that no part of mycompensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed
in this report.
For Additional Information Contact:Stonegate Securities, Inc.Marco Rodriguez , [email protected]
Please note that this report was originally prepared and issued by Stonegate for distribution to their market professional and institutionalinvestor customers. Recipients who are not market professional or institutional investor customers of Stonegate should seek the advice of theirindependent financial advisor prior to taking any investment decision based on this report or for any necessary explanation of its contents. Theinformation contained herein is based on sources which we believe to be reliable, but is not necessarily complete and its accuracy cannot beguaranteed. Because the objectives of individual clients may vary, this report is not to be construed as an offer or the solicitation of an offer tosell or buy the securities herein mentioned. This report is the independent work of Stonegate Securities and is not to be construed as havingbeen issued by, or in any way endorsed or guaranteed by, any issuing companies of the securities mentioned herein. The firm and/or its
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