2014 annual report - immunomic therapeutics · allergy vaccine therapy where the immune system is...
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2014 Annual Report
Immunomic Therapeutics, Inc.
Hershey, PA
April 2015
April 2015
ContentsContents ......................................................................... 1
Executive Summary ........................................................ 2
Message to the Shareholders from the Chairman ......... 3
Letter from the CEO........................................................ 5
LAMP Technology for the Treatment of Allergy............. 7
JRC-LAMP-vax / ASP4070 ............................................... 8
Immunomic Therapeutic Product Pipeline..................... 9
ASP4070 / JRC2-LAMP-vax ................................ 9
ARA-LAMP-vax................................................... 9
Food Allergy Represents a Growing Problem............... 10
Multi-allergen formulations ............................ 11
Oncology.......................................................... 11
Grant Support for Immunomic Therapeutics .. 11
Management ................................................................ 12
Board Of Directors 2014-2015...................................... 14
Company Operations.................................................... 18
Capitalization & Ownership.......................................... 18
Financial Overview ....................................................... 18
Executive SummaryThe last twelve months has seen Immunomic Therapeutics evolve
from a Company with a Vision to an emerging BioPharma with a
major industry partner.
Supported by world class research, the Company has advanced its
proprietary LAMP-vax Platform into a robust product pipeline of
products that will transform the way doctors treat allergy.
The new business and research alliances have created an
environment for Immunomic Therapeutics to create exceptional
shareholder value.
Contact Information:
Immunomic Therapeutics, Inc.
1214 Research Blvd, Suite 2016
Hummelstown, PA 17036
15010 Broschart Road, Suite 105
Rockville, MD 20850
Ph: 717-327-1919
Web: www.immunomix.com
Twitter: twitter.com/immunomix
Facebook: Immunomic Therapeutics
April 2015
April 2015
Message to the Shareholders from the Chairman
Dear Shareholders,
As Chairman of the Board of Immunomic Therapeutics, I ampleased to say that along with the significant progress by themanagement team on clinical product development of our LAMPtechnology, the Company was on the threshold of a major businessdevelopment milestone during 2014. At year end, ITI was in late-stage negotiations with a major Japanese Pharma company forexclusive rights in Japan for the company's first LAMP-based vaccineto treat allergic disease to Japanese Red Cedar (JRC) pollen.These discussions were successfully completed in January 2015, and will provide ITI with its firstcorporate partner to not only clear the path to market our next generation vaccine technology in Japanbut also creates opportunity to expand this partnership with additional LAMP-vaccines to treat otherallergies in Japan, while enhancing our visibility within the Pharma industry for additional partnershipsto address the global allergy market.
During the pursuit of this corporate alliance strategy lead by our CEO and I, the Board through itsvarious committees and meetings with management, maintained a watchful oversight on the use ofcorporate resources to assure the maximum opportunity for success. As a Board, we fully supportmanagement’s position regarding the Company’s commercial strategy. Care is being taken to assure thatpotential agreements, while offering short term results, do not create longer term constraints,obligations or impairments that may reduce shareholder value. As a Board, we believe that theappropriate terms and conditions are incorporated into commercial arrangements being discussed.
As Chairman of the Board, I would also like to complement our CEO, Bill Hearl, for his leadership inguiding his limited management team in overcoming the challenges faced in 2014 to accomplish thecompany's objectives. As the company is now in the late-stages of becoming an ongoing enterprise, theBoard also recognizes that to achieve the business goals for 2015 and beyond will require additionalresources and expertise in our management team, and has thus authorized our CEO to proceed toexpand his executive team as a priority in the 2015 budget.
I continue to remain confident in the opportunities that lie ahead for ITI in the global allergic diseasemarket, and in additional human disease markets as we expand our internal resources and implementour Pharma partnering strategy. The Board of Directors will continue to be there to advise, challengeand provide appropriate directions as the management of the Company initiates and increases the levelof commercial and operational activities that will increase shareholder value in 2015 and beyond.
W. Barry McDonald
April 2015
MISSION
“Immunomic Therapeutics ispioneering vaccines that willtransform lives”
P R O M I S E
“Immunomic Therapeuticspromises to its community ofinvestor and pharmaceuticalpartners products with a clearbusiness case supported byrigorous scientific data.”
April 2015
Letter from the CEODear Shareholders,
The Management Team had developed a vision for success: build an allergy
vaccine against a key regional target, demonstrate sufficient efficacy to
attract a partner and use the revenue from that deal to build a more
substantial company. How we arrived at this vision and then its successful
execution is an interesting story.
In 2007 (or thereabouts) I received an e-mail correspondence from Dr. Tom
August regarding a seminar he had attended at the National University of
Singapore. A colleague at NUS, Dr. Kaw-Yan Chua, had given a presentation
on an application of LAMP with house dust mite antigen (Der P2) as an allergy
model. Her data showed that LAMP induced a potent Th1 (non-allergic) response with no detectable free
allergen found – a new safety paradigm in allergy therapy. Tom’s message to me was fairly simple…”you’re
going to be a millionaire!” It was clear to both of us that allergy represented a unique opportunity where our
technology, a medical need and a great market opportunity intersected to our advantage.
The early days of the Company were based inside my former company, Capital Genomix (Jim Wishart was the
CEO) and I occasionally hosted meetings for a Tech focus group (270Tech) in the evenings…it was free pizza, so
the price was right. One evening, a gentleman arrived about an hour early and I sat with him in the kitchen and
had a dialog. It turned out this person was a regulatory and clinical expert – AND an immunologist – exactly
what the Company needed to go forward. I immediately made Bruce Mackler a proposal to join ITI as its
Regulatory executive and he graciously accepted.
A key ingredient for the success of any biotech startup is working capital. I worked closely with Bernie Rudnick
starting in 2007, and over the years, we were able to raise over $10 million in angel investment. This included
an important relationship with the Life Sciences Greenhouse of Central Pennsylvania. Current Board member
and vaccine expert Ron Thiboutot recognized promise in our Company and supported the proposed investment.
Their initial placement in early 2010 evolved into our first major funding round (almost $2 million).
After presenting our business story to various private investors and with subsequent funding in hand, our VP of
R&D Dr. Teri Heiland finally had the resources to start to build our first allergy vaccine. With some
brainstorming around clinical trial design from Bruce, a suggestion on the allergy problem in Japan from our
Chairman, Barry McDonald and design concepts from Teri, we zeroed in on Japanese red cedar allergy as the
perfect fit for our vision. Thirty-five million potential patients in a single territory that did not include the U.S. or
Europe and deal comparatives in the $30-$50 million range made JRC look like a perfect fit.
Our little Company of now 5 people, with Sia Anagnostou and Mike Connolly on board as our first non-founder
employees, started down the path of clinical studies. Somehow, with the help and support of many, we
managed to make product, qualify it, get an IND submitted and approved, a clinical site with Japanese subjects
identified and ultimately a Phase I study conducted over a 12 month period in 2012 – 13.
April 2015
Now we had data! And remarkable data it was – showing that our JRC allergic subjects has converted their skin
tests from positive to negative over a period of about 6 – 9 months. This observation was further supported by
compelling mouse data in our labs. We felt confident that we could take this message to the marketplace and
find a partner in Japan.
In February 2014, our business development team (composed of Barry McDonald and myself, supported by our
Director of Business Development, Colin Magowan) presented a “teaser document” to 21 Japanese pharma
companies, scheduled meetings with 9 of those and had 6 companies enter due diligence by June 2014. During
the due diligence process, it was clear some of the companies were hesitant to proceed without some guidance
from the Japanese regulatory authority, PMDA. Bruce Mackler addressed this problem head-on by preparing to
file a CTN (an IND in Japan) and arranged for both an informal consultation and then a formal consultation with
the Japanese regulatory agency. In October, Bruce and I met with PMDA and essentially obtained their
endorsement to proceed into the clinic in Japan. This key event greatly enhanced our position with the
companies in discussion and one company, Astellas Pharma, advanced their proposal to a Term Sheet before
Thanksgiving. (Turkey last year never tasted so good!)
Over the next 60 days, our BD team worked tirelessly with our counterparts at Astellas to convert the Term
Sheet into an Agreement. On January 30, 2015, the deal was signed and jointly announced globally, giving
Astellas exclusive rights to our Japanese red cedar allergy vaccine (internally now known as ASP4070), in Japan
in return for upfront and future milestone payments that will total up to $70 million, with another $30 million in
additional support of all clinical studies in Japan followed by multi-tiered future royalties on sales.
In summary, essentially, nine key people translated our Vision for ITI into a Reality - an amazing accomplishment
and a job well done. Our thanks go out to the entire Immunomic Team.
So what’s next? The $15 million Astellas upfront payment has put Immunomic Therapeutics in an exciting
position to build on our original vision. We are now in a position to focus on the next phase of our Company’s
future. Our expectations have not changed – we still believe and fully expect to create exceptional shareholder
value through development of the LAMP Technology Platform. What has changed is our ability to implement
our clinical and product strategy. As you will see in this report, we are moving our second key product for
peanut allergy into the clinic later in 2015. We have developed a strategy for the major environmental and food
allergens that we believe makes ITI the most compelling allergy company in a market starving for something
new and innovative.
Our commitment to you, our valued investors, is to continue to keep Immunomic Therapeutics on the path of
positive progress – with our partnership with Astellas, with new partners yet to be identified and with the
carefully guided development of our product pipeline. We look forward to an exciting 2015 and the
opportunities it will bring. Thank you for your continued support.
April 2015
LAMP Technology for the Treatment of Allergy Represents a
New Therapeutic Paradigm: treat the disease by positively
interacting with the immune system
LAMP-vax Technology
represents the first new
therapeutic approach for
allergy in over 100 years.
Since 1911, allergists have
focused on establishing
tolerance in patients by giving
them repeated injections of
small amounts of allergenic
proteins. This approach
generally has an effective rate
of about 30% in the patients
that choose to continue
therapy – only about 20% who
start allergy immunotherapy.
LAMP-vax is not
immunotherapy – rather it is
Allergy Vaccine Therapy
where the immune system is
educated in a positive way to
mount a non-allergic Th1
response.
Allergy is generally believed to
occur when the immune
system mounts a Th2
response resulting in the
formation of allergen –
specific IgE. Upon repeat
exposure, the IgE stimulates
Mast cells to release
histamine. We believe LAMP-
vax therapy can replace the
allergic response with a
normal, Th1 response.
TEACHING THEIMMUNE SYSTEM
April 2015
Japanese Red Cedar Allergy Vaccine – JRC-LAMP-vax / ASP4070
Our Lead Product in development with Astellas
35 MILLION JAPANESE SUFFER
FROM JAPANESE CEDAR POLLINOSIS
ADULT MARKET SIZE COULD REACH
$70 BILLON
Moderate
Allergic
Severe
Japanese Cedar Allergy
Market
April 2015
Immunomic Therapeutic Product Pipeline
ASP4070 / JRC2-LAMP-vax
Immunomic Therapeutics’ lead product, now under license to Astellas Pharma Inc., for exclusive development
and commercialization in Japan, is designed to induce an immune response to the two major allergens
responsible for Japanese red cedar allergy: Cry J1 & Cry J2. Formulated as a DNA vaccine incorporating ITI’s
patented LAMP Technology, ASP4070 will be entering a new Phase I clinical study in Japan, under the direction
of Astellas, in mid-2015 with market entry targeted by 2020.
ARA-LAMP-vax
ITI’s first food allergy vaccine addresses the growing need for a solution to peanut allergy. This vaccine
addresses the 3 major allergens believed to be responsible for peanut allergy. The safety profile of the LAMP-
vax platform is particularly appealing for application in food allergy because of its ability to mitigate the risk of
anaphylaxis in these patients. Unlike pollen allergies which rarely cause extreme allergic responses, food
allergies in rare instances can be fatal. However, since the LAMP-vax approach does not expose the patients to
free allergen, this risk is greatly reduced. To support the initial development of this product, ITI recently was
awarded a $1.3 million US DOD grant and a $230,000 SBIR grant to accelerate production of clinical grade
vaccine.
Commercial Partner /
Academic CollaboratorDesign
AnimalPOC
Pre-Clinical
Ph. I Ph. II Ph. III
ALLERGY VACCINE THERAPY
JRC-LAMP-vax • Japanese Red Cedar Astellas
MC-LAMP-vax • Mountain Cedar Internal Development
ARA-LAMP-vax • Peanut Internal Development
Multi-LAMP-vax • Multivalent Internal Development
ONCOLOGY IMMUNOTHERAPY
AST-VAC1 • Prostate Cancer & AML BioTime / Asterias
AST-VAC2 • AML and Other BioTime / Asterias
LAMP + pp65 DC Therapy • Glioblastoma Duke University
LAMP + antigen mRNA • Glioblastoma University of Florida
Food Allergy Represents a Growing Problem in Children & Ad
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ARA-LAMP-vax is a
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this product can truly
April 2015
2002 2008
Child <18 Y TOTAL
transform lives.
April 2015
Multi-allergen formulations
Our belief is that allergy will be best treated in the broader market by developing an allergy vaccine that
addresses many if not all of the major allergens in a single formulation. Based on the unique scientific approach
and safety profile of our LAMP vaccines, we believe it will be possible to create a series of global or regional
vaccines that would include candidate allergens such as cat, ragweed, house dust mite and timothy grass. Our
research team has been actively developing a number of these targets with the goal of entering the clinic with
up to three additional targets in 2016. As a model multi-allergen approach, the Company received an SBIR
($280,000) for the treatment of multiple tree nuts in a single formulation.
Oncology
Immunomic Therapeutics has been able to support multiple research programs in key academic centers working
on vaccine immunotherapy that incorporate the LAMP-vax Technology. Researchers such as Dr. Duane Mitchell,
who has recently been featured in the popular media as a cancer innovator, has been working with Immunomic
scientists on their vector designs. Although the Company does not have any specific plans to develop an
oncological application based on LAMP at this time, we will continue to work with and monitor the progress of
our colleagues in academia.
Grant Support for Immunomic Therapeutics
In 2014, Immunomic Therapeutics was awarded two SBIR grants to support the development of its food
allergy program. The first grant ITI received was for a Multi-Tree Nut Allergy Vaccine. This product in
development is starting with a nine-allergen composition that will address multiple nut allergies in a single
course of therapy. This award was followed by a new grant for the development of an advanced peanut allergy
vaccine with an enhanced safety profile. And finally, early in 2015, the Company was awarded a grant to
support the manufacture of clinical lots of the peanut allergy vaccine along with support for pre-clinical
validation of this vaccine. In total, these awards will bring an additional $1.8 million into the Company allowing
more rapid development of our Allergy Vaccine Platform.
April 2015
Our progress has been accomplished through the efforts of our great Team. Immunomic Therapeutics is
assembling a world-class staff to implement our Business Vision. Joining the Company in 2015 are several key
members of Executive Management: Dr. Tim Coleman, as VP of Operations, Mr. Eric Winzer as Chief Financial
Officer and Ms. Louise Peltier as VP of Regulatory Affairs. These additions give ITI a full Executive Management
Team for the first time in the Company’s history.
1 Immunomic Therapeutics, December 2014. Bill Hearl, Teri Heiland, Tony Marketon, Bernie Rudnick,Melissa Kemp, Jim Wishart, Josephine Ramos, Eliezer Romeu, Sia Anagnostou, Yan Su, Mike Connolly
Management
A note from the CEO: With progress, also comes change. As the Company moves into its next phase of growth,we will be welcoming a number of key new employees to our Executive Team such as Eric Winzer as CFO andLouise Peltier as VP of Regulatory Affairs. This also means that we have to say “farewell” to three key membersof our Team that have served so effectively for ITI as interim management over the last few years. BernieRudnick has been instrumental in building value for our shareholders and was our lead financier since January2007. Bruce Mackler joined the Company shortly after that and built a regulatory strategy that was bothinnovative and cost-effective – just what our nascent biopharma company needed. Without their contributions,we would not have been able to bring the Allergy Vaccine Therapy program to its current status as an emergingforce in allergic therapy. We also have to thank Jim Wishart who for the last two years has been ActingController and has mediated our interface with our Auditors and brought a new level of detail to our accountingand record-keeping functions. The Company and I thank you very much for your service.
Great People Make
Great Companies
April 2015
William Hearl, Ph.D., CEO & President
Dr. William Hearl, the founder of ITI, is an experienced and successful scientific businessman and entrepreneur.He worked closely with Dr. Tom August, Capital Genomix, Inc., and Johns Hopkins University to capture the LAMPTechnology for ITI and begin operations in 2006. His extensive experience in intellectual property managementand business development led to the speedy sub-license of the LAMP technology to Geron.
Corporation within 30 days of initiating operations. Dr. Hearl is also the founder of Capital Genomix, Inc. (CGI), aMaryland-based biomarker and drug discovery company, having served as its first CEO from inception in 2000until late 2002 when he assumed the role of Chief Scientific Officer. Dr. Hearl raised seed and Series A & B fundingfor CGI (~$5 million in cash/debt) and acquired the Dynex Technologies division of Thermo Scientific in a leveragedacquisition deal. (Dynex was subsequently divested yielding a 10-fold return to the Company). He is alsoresponsible for the acquisition and development of the core technologies of Capital Genomix: GeneSystem320™was licensed exclusively from MD Anderson Cancer Center and the ImmunoMouse™ was invented by Dr. Hearl.Dr. Hearl also has an established record of scientific productivity over his 20 years of work in the biotech industry.He started his career as a bench scientist at Electro-Nucleonics, Inc. and developed blood based diagnostics forHIV, HTLV-I and Hepatitis C. He later worked at Life Technologies Corporation (now part of Invitrogen) and directedthe Immunodetection Group. His lab developed a number of innovative antibody-based detection kits andreagents. He moved into scientific management when he became the Director of R&D at Kirkegaard & PerryLaboratories, Inc. in 1994. Dr. Hearl has a Ph.D. in biochemistry from the University of Tennessee (Oak Ridge,Knoxville) and a B.S. from East Tennessee State University.
Teri Jones Heiland, Ph.D., Vice President of R&D
Dr. Heiland is currently the Vice President of Research and Development at ITI and was one of the foundingemployees of the Company. Dr. Heiland is an experienced molecular biologist and holds multiple patents in thefield of genomics. Prior to assuming the post as Vice President at ITI, Dr. Heiland led multiple research teams atCapital Genomix, Inc. developing and validating GeneSystem320™ and applying this technology to identifybiomarkers associated with cancer. She has also worked closely with the development of the ImmunoMouse™and is an expert in molecular biology and genomic analysis. Prior to joining Capital Genomix, Dr. Heiland workedas a senior scientist in R&D at Kirkegaard & Perry Labs (KPL) where she spent four years as a project leader ondevelopment and commercialization of six major kits and she was responsible for the utilization of GS320™ withboth cytokine and HIV model systems. She has facilitated the optimization of the GS320 assay and has beeninvolved in work involving eukaryotic gene regulation since 1989. She has expertise in the fields of signaltransduction, amphibian development, and gene regulation. Dr. Heiland is primary author on a number ofpublications that utilized extensive work with mRNA and cDNA and assays such as RT-PCR, RNAse ProtectionAssays, Northern Blotting, as well as, library cloning and screening. Dr. Heiland obtained her Ph.D. in molecularbiology at the University of Missouri-Columbia in 1993.
Tim Coleman, Ph.D., Vice President of Operations (effective January 15, 2015)
Dr. Coleman comes to ITI with broad experience in the life sciences industry. Most recently, he wasSenior Director of New Product Development at SeraCare Life Sciences, Gaithersburg, MD; prior tothat, Dr. Coleman worked at Lonza Bioscience, Inc., Walkersville, MD where he held leadership roles inProduct Development and Quality Control. At ITI, Dr. Coleman will have an assortment ofresponsibilities including expanding the capabilities of the Company’s Hershey, PA operations along
April 2015
with leading ITI’s CMC Team in the new collaborative effort with Astellas Pharma. Dr. Coleman hasmore than 40 publications and 26 issued patents. He obtained his BA degree from Rutgers-Newark anda Ph.D. in Molecular and Cellular Biology from Ohio University.
Eric Winzer, Chief Financial Officer (effective May 4, 2015)
A 30-year veteran of life sciences companies, Mr. Winzer has addressed a wide array of financial issues fromraising capital, financial reporting, investor relations, banking, taxation, mergers and acquisitions to financialplanning and analysis, and accounting operations. Most recently, he was CFO of OpGen where he wasresponsible for all financial functions at the company. Prior to joining OpGen, Mr. Winzer served as executivevice president and CFO for Avalon Pharmaceuticals, Inc., a biotechnology company developing targetedtherapeutics for oncology. Prior to Avalon, Eric was with Life Technologies Corporation (formerly InvitrogenCorporation), a provider of life science technologies for disease research and drug discovery, where he served assenior VP and CFO, executive sponsor for Life’s ERP implementation, and as the VP of finance. Currently, Mr.Winzer also serves as director and audit committee chair at Cytomedix, Inc. He received his BA in economicsand business administration from McDaniel College and an MBA from Mount Saint Mary’s University.
Louise Peltier, VP of Regulatory Affairs (effective May 4, 2015)Ms. Louise Peltier is a Regulatory Affairs Professional with over 30 years of hands-on/multi-discipline experience
with pharmaceuticals, biologics and in-vitro diagnostics. She has over thirty years expertise on US, Canadian, and
EU registration process from beginning to end including direct agency interactions. She has developed regulatory
strategy at all stages of development for therapeutic biologics, in-vitro diagnostics and new chemical entities for
both US and EU registrations. She was most recently the Senior Director of Regulatory Affairs for Phamathene;
prior to that role she held similar positions at Caris Life Sciences and Northwest BioTherapeutics.
Board Of Directors 2014-2015
William Hearl, Ph.D., Chief Executive Officer & President
See Bio above.
W. Barry McDonald, Chairman
Mr. McDonald has over 40 years’ experience in the health care industry as an operating executive, board directorand consultant. As Chief Executive for McDonald & Associates, a strategic and transactional global health careadvisory firm established in 2008, he currently manages client assignments globally in the medical diagnostics,biotechnology, pharma, medical device and life science sectors, provides interim CEO management services tocompanies in these sectors, and also advises many Boards and private investors of several global client companiesduring and following assignments.
Mr. McDonald was interim President and CEO of TSO3 from April-October 2008, a publicly traded Canadianmedical device company, following election by TSO3 Board of Directors prior to the AGM meeting following theabrupt resignation of the co-founder/CEO. He was responsible for revising the company’s development andmarketing strategies, resulting in increased revenues while significantly reducing expenses during his executive
April 2015
tenure. Mr. McDonald, after assisting the Board in identifying a search firm for a permanent CEO, subsequentlyjoined the Board and remains a Director and member of the Audit and Strategic Advisory Committees. Mr.McDonald has served on the Board of Immunomic Therapeutic since 2008 and remains Chairman of the Boardfollowing his election in 2011. He currently serves on the Advisory Board of Zeus Scientific, a private US-based IVDcompany.
Previously, he was also Executive Director and Principal with The Sage Group, a global healthcare consultancy. Hewas directly involved in over 150 client assignments encompassing strategic assessment, technologydevelopment, acquisitions, divestments, restructuring, corporate licensing and alliances, valuation analysis,market entrance strategies (EU to US, US to EU and Asia to US), due diligence analysis, expert testimony, andmarket assessments and analysis involving diverse technologies and products in healthcare. He also served asInterim Executive for many client assignments.
Prior to consulting to the industry, Mr. McDonald was President/CEO of Mast/Hitachi, the second largest globalallergy diagnostic company, with additional responsibility for heading an executive staff within Hitachi Chemicalcorporate for assessment of new technology, acquisitions and internal technology development within its lifesciences group. He also was President/CEO of Photest, a US venture-backed company concentrating on novel,medical products for the point-of-care market, and lead the ultimate sale of the company to a Europeancorporation. Mr. McDonald was General Manager and Executive Board Member of Boots-Celltech, a joint venturebetween Boots Pharmaceutical and Celltech Limited in the UK, and was instrumental in negotiating a sale of thecompany’s products and technologies to two separate US companies. His corporate experience was gained inexecutive positions with the Ortho Diagnostics division of Johnson & Johnson and multiple operating divisions ofAmerican Hospital Supply (now Baxter International and Siemens Healthcare).
Mr. McDonald’s broad health care business expertise has been augmented through participation in internationalstrategic management schools in France, Japan, and the United States at Wharton Business School and ColumbiaUniversity. Mr. McDonald's academic accomplishments include an MD/PhD program at the University ofKentucky, Albert Chandler Medical School, an M.S. in Microbiology and Genetics and a B.S. in Biochemistry andpre-med from The University of Southern Mississippi.
Bruce F. Mackler, Ph.D., J.D.
Dr. Mackler’s 27 years of FDA legal/regulatory experience in biomedical products includes biologics, drugs,medical and in vitro diagnostic devices, manufactured by traditional and biotechnology processes (recombinantproteins, genomics, allergens, active and passive vaccines, cell and gene therapy). Dr. Mackler has advisedfinancial groups on integrated FDA, technical and business issues, when performing due diligence assessments onbiomedical opportunities prior to their making initial investments and during bridging. These due diligenceactivities integrate his business acumen from working in sales/manufacturing in a family textile business, owningand managing several bioservice businesses and being a university/NIH researcher for 15 years, prior to his 27years in a FDA legal/regulatory practice with premier law firms. He has founded biomedical companies,established and implemented their regulatory strategies and also assisted in securing early stage funding.
Dr. Mackler has a Ph.D. and M.S. in the area of Immunology/Microbiology and has authored more than 100published scientific papers and abstracts in immunology, immunopathology, allergy and diseases, as well asnumerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Macklerhas advised clients and venture capital groups on FDA regulatory approval strategies for their portfolio companies,regulatory/quality problems regarding establishing manufacturing facilities and how to effectively initiate product
April 2015
development and interact with FDA. Dr. Mackler has experience drafting and evaluating numerous FDA regulatorydocuments (e.g., INDs/NDAs, DMFs, and BLAs, Accelerated and Fast Track Approvals, as well as Orphan DrugDesignation applications). He has, as a U.S. agent, held IDEs/INDs and secured Treatment-INDs with substantialcost reimbursement, and has written successful Orphan Drug Development/SBIR grants and Designationapplications; therefore, he is familiar with the nuances of these regulatory procedures. Dr. Mackler received hisJ.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) fromthe University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania StateUniversity (1965), and his B.A. (Biology) from Temple University (1964).
Bernard C. Rudnick
Bernard C. Rudnick is founder and managing partner of CapGenic Advisors, LLC, and a member of several angelgroups. Mr. Rudnick’s entrepreneurial career includes a number of startups, three of which grew to over $60million in revenue before exiting. He is a founder of one of the nation’s leading entrepreneurial programs (MADV)at the Fox School of Business, a director of Otosound, director and acting-CFO of Immunomic Therapeutics andhas held a number of other board positions – both commercial and not-for-profit – throughout his career. With36 years of experience in executive-level strategy, finance, and management, Mr. Rudnick has senior merger,acquisition, capital formation and licensing leadership experience with companies ranging from start-up toFortune 50. Mr. Rudnick has substantial experience investing and guiding investments in entrepreneurialcompanies, he has led capital formation totaling more than $530 million in the past ten years and $3B during thelast 15 years. Mr. Rudnick currently advises companies in the clinical software space, therapeutic, medical device,and in the cell line engineering areas. His advisory clients have included Mitsui (Mitrix), DuPont (Agri-chemical),McKesson Bioservices (now TMO), Kika Clinical Solutions (now MRGE) as well as a number of early stage lifesciences companies. Bernie received his BS in Biochemistry from Pennsylvania State University and an MBA fromNorthwood University (formerly Northwood Institute).
James W. Wishart
James W. Wishart has been the President, CEO and a Director of Capital Genomix, Inc. since 2002. Prior to 2002,Mr. Wishart was the founder of Odyssey Diagnostics Inc., and has served as the CEO of Odyssey Diagnostics Inc.since its inception in 2001. During 2002, he facilitated the merger of Odyssey Diagnostics, Inc. and CapitalGenomix, Inc. From 1997 to 2001, he served as the President and CEO of DYNEX Technologies, Inc., which was awholly owned subsidiary of Thermo Electron Corp., a $5.4 billion public company (TMO). From 1993 to 1997, Mr.Wishart served as the President and CEO of Spectra-Tech, Inc., a subsidiary of Thermo Optek Corp., a $250 millionpublic company (TOC), and a worldwide leader in the development, manufacturing and marketing of FTIRmicroscopes, accessories and software for the analytical instrumentation market. Mr. Wishart received his BSdegree from Geneva College and has served on several Boards of Directors, including those of Thermo BioAnalysis,Ltd., DYNEX Technologies, Inc., Spectra-Tech, Inc., and the S.P. Japan, Inc. Board of Directors.
Ronald P. Thiboutot, Ph.D., LSGPA Affiliate
Ronald P. Thiboutot, Ph.D., is Senior Vice President of Science and Technology for the Life Sciences Greenhouseof Central Pennsylvania (LSGPA). His responsibilities include identifying promising new areas of technology,reviewing science and business opportunities, and investing in seed stage opportunities. Prior to joining the LifeSciences Greenhouse, Dr. Thiboutot was President of RT Consultants, Inc. which provided technical, equipmentprocurement, and facility design consulting services to the US and EU pharmaceutical industry. Among his otheremployers were: Wyeth Pharmaceuticals, where he was the Plant Director of the vaccine manufacturing facility
April 2015
located in Marietta, PA; Bristol-Myers Squibb, where he worked in the international technology transfer division;and Baxter Travenol. Dr. Thiboutot holds a Bachelor of Science, Masters of Science, and Ph.D. from theMassachusetts College of Pharmacy, and has been active in numerous U.S. and International pharmaceutical tradeorganizations during his 25 years in the pharmaceutical industry.
Michael Lack, LSGPA Affiliate
Michael Lack consults with organizations in the biotechnology and informatics sectors. Until recently, he was
Chief Operating Officer of Incyte Genomics, responsible for all operating functions including sales and marketing,
production, and informatics. Prior to his tenure at Incyte, he was President and CEO of Silicon Valley Networks,
and President and CEO of Presidio Systems, Inc. Earlier, at Cadence Design Systems, he had been Senior VP of
Product Operations; Division President, Integrated Circuit Design Division; and Division President, Systems
Division.
April 2015
Company OperationsThe company’s molecular biology and mouse laboratory is located at 15010 Broschart Rd., Suite 250, Rockville,MD, 20850 right across from the Shady Grove Johns Hopkins Campus. Our corporate headquarters are nowlocated at our process development facility in Hershey, PA. The business address is 1214 Research Boulevard,Suite 2016, Hershey, PA 17036. In early 2015, the Company also expanded to add Suite 105 at the Broschart Roadfacility adding office and laboratory space. In 2015, the Company will be seeking to expand its manufacturing andoffice facilities in Pennsylvania to increase our production and process development capabilities.
Capitalization & OwnershipITI is a privately–held C corporation chartered in the State of Delaware. The Company has issued approximately9,756,477 shares of Common Stock and 1,535,245 of Preferred Series A Stock (which converts to 2 shares ofCommon) as of the date of this Plan. The top 10 Shareholders own approximately 49% of the Company whichincludes the Hummel Family Trust, the Trisiras Group the Life Sciences Greenhouse, the Jordan Family Office, theRathmann Family Office and the CEO, William Hearl.
Financial OverviewTHE PROJECTIONS COVERED IN THE FINANCIAL PLAN AND PROJECTIONS ATTACHED HERETO ARE SUBJECT TORISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FORM THOSEPROJECTED AND DO NOT CONSTITUTE A REPRESENTATION OR WARRANTY OF PERFORMANCE BY ANY PARTYHERETO.
Immunomic Therapeutics has operated a highly capital efficient business since its inception, having raisedapproximately $11 million through 2013. In 2014, the Company closed on October 8 a Series A Preferred financingresulting in gross proceeds of $6.9 million, resulting in a total capital investment since inception of $17.2 million.The Company received the funds during 2014 on a “rolling close” basis and put a portion of those funds to use in2014 to support the further development of JRC-LAMP-vax. This included manufacture of a new lot of vaccinefor use in clinical studies both in the U.S. and in Japan. The Company also made a significant investment in filingwith the PMDA (the Japanese regulatory agency) to conduct a clinical study in Japan either in late 2014 or early2015. These efforts were instrumental in capturing the license deal in January 2015 with Astellas.
Elanco
In 2011, Immunomic Therapeutics negotiated an Animal Health license agreement with Eli Lilly’s animal healthdivision, Elanco. Due to multiple factors during the collaborative development phase, both companies determinedto end the collaboration and in March 2015, Elanco returned the license, all rights to LAMP in Animal Health andall data related to product development to Immunomic Therapeutics. As a result, future revenues frommilestones and royalties will not be realized in Animal Health until a new partner is identified.
Results of 2012-2013 Audit
The Shareholders approved BDO as the auditors for Immunomic Therapeutics. The Company completed a full
audit and received a report with fully audited financials on November 11, 2014 for Fiscal Years 2012 & 2013.
The Audit is on file at the offices of the Company and is available for review upon request.
April 2015
ITI ACTUALS AND BUDGET/PROJECTIONS
Actual for Actual for Actual Pro Forma
Total Year Total Year Total Year Total Year
2012 2013 2014 2015
Revenues
Elanco $ 725,266 $ 121,950 $ 76,975
Grants $ 40,901 $ 1,555,217
Astellas CMC $ 2,050,000
R&D Reimbursement $ 10,000,000
Licensing Revenue $ 5,000,000
Total Revenue $ 725,266 $ 121,950 $ 117,876 $ 18,605,217
COGS $ 208,457 $ 18,326 $ 31,413 $ 255,217
Gross Profit $ 516,809 $ 103,624 $ 86,463 $ 18,350,000
EXPENSES:
Clinical Expense $ 651,234 $ 556,762 $ 2,126,682 $ 1,814,475
R&D $ 591,335 $ 746,325 $ 664,034 $ 953,687
Sales/Mktg. $ 29,000 $ 27,434 $ 90,117 $ 90,000
G&A $ 1,279,670 $ 1,268,435 $ 2,016,750 $ 3,384,833
Process Development $ 142,731 $ 375,224
Licensing Fees $ 50,000 $ 378,834 $ 179,757 $ 1,175,0001
Interest Expense $ 29,123 $ 67,789 $ 22,256 $ -
Total Expenses $ 2,630,362 $ 3,045,579 $ 5,242,327 $ 7,793,219
Non-Cash Expense $ 132,485 $ 408,559 $ 822,090 $ 1,878,0002
Net Income (Loss) $ (2,227,107) $ (3,344,391) $ (5,976,072) $ 8,688,481
Notes:
1. 2015 reflects one-time expenses of payments to License Holders related to Astellas transaction.
2. Non-cash expenses include stock options accrued for stock option compensation, accrued bonuses for Management for 2016,
vacation accrual and depreciation expense.
April 2015
Immunomic Therapeutics, Inc
Hershey Facility
Process Development Lab & HQ1214 Research Blvd, Suite 2016
Hummelstown, PA 17036
Rockville Facility
Research & Development & Admin15010 Broschart Road, Suite 105
Rockville, MD 20850
Phone: 717-327-1919
Fax: 717-685-3728
Web: www.immunomix.com
Twitter: www.twitter.com/immunomix
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