2014 Annual Report
Immunomic Therapeutics, Inc. Hershey, PA April 2015
Contents Contents ......................................................................... 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
April 2015
Executive Summary The 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
Message to the Shareholders from the Chairman Dear Shareholders, As Chairman of the Board of Immunomic Therapeutics, I am pleased to say that along with the significant progress by the management team on clinical product development of our LAMP technology, the Company was on the threshold of a major business development milestone during 2014. At year end, ITI was in latestage negotiations with a major Japanese Pharma company for exclusive rights in Japan for the company's first LAMP-based vaccine to treat allergic disease to Japanese Red Cedar (JRC) pollen. These discussions were successfully completed in January 2015, and will provide ITI with its first corporate partner to not only clear the path to market our next generation vaccine technology in Japan but also creates opportunity to expand this partnership with additional LAMP-vaccines to treat other allergies in Japan, while enhancing our visibility within the Pharma industry for additional partnerships to address the global allergy market. During the pursuit of this corporate alliance strategy lead by our CEO and I, the Board through its various committees and meetings with management, maintained a watchful oversight on the use of corporate resources to assure the maximum opportunity for success. As a Board, we fully support management’s position regarding the Company’s commercial strategy. Care is being taken to assure that potential 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 the appropriate 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 in guiding his limited management team in overcoming the challenges faced in 2014 to accomplish the company's objectives. As the company is now in the late-stages of becoming an ongoing enterprise, the Board also recognizes that to achieve the business goals for 2015 and beyond will require additional resources and expertise in our management team, and has thus authorized our CEO to proceed to expand 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 disease market, and in additional human disease markets as we expand our internal resources and implement our Pharma partnering strategy. The Board of Directors will continue to be there to advise, challenge and provide appropriate directions as the management of the Company initiates and increases the level of commercial and operational activities that will increase shareholder value in 2015 and beyond.
W. Barry McDonald
April 2015
M IS S ION “Immunomic Therapeutics is pioneering vaccines that will transform lives”
PROMISE “Immunomic Therapeutics promises to its community of investor and pharmaceutical partners products with a clear business case supported by rigorous scientific data.”
April 2015
Letter from the CEO Dear 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
TEACHING 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 LAMPvax therapy can replace the allergic response with a normal, Th1 response.
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 Severe
Moderate Allergic
Japanese Cedar Allergy Market
April 2015
Immunomic Therapeutic Product Pipeline Design
Animal POC
PreClinical
Ph. I
Ph. II
Ph. III
Commercial Partner / Academic Collaborator
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
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 LAMPvax 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.
April 2015
Food Allergy Represents a Growing Problem in Children & Adults ARA-LAMP-vax is a potential game-changer in treating food allergy. With an unprecedented safety profile and a unique mode of action, this product can truly transform lives.
Child <18 Y
TOTAL
3,500,000.00
# of US Peanut Allergic
3,000,000.00 2,500,000.00 2,000,000.00 1,500,000.00 1,000,000.00 500,000.00 0.00
1997
2002
2008
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
Great People Make Great Companies 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 and Louise Peltier as VP of Regulatory Affairs. This also means that we have to say “farewell” to three key members of our Team that have served so effectively for ITI as interim management over the last few years. Bernie Rudnick has been instrumental in building value for our shareholders and was our lead financier since January 2007. Bruce Mackler joined the Company shortly after that and built a regulatory strategy that was both innovative 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 emerging force in allergic therapy. We also have to thank Jim Wishart who for the last two years has been Acting Controller and has mediated our interface with our Auditors and brought a new level of detail to our accounting and record-keeping functions. The Company and I thank you very much for your service. 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 LAMP Technology for ITI and begin operations in 2006. His extensive experience in intellectual property management and 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), a Maryland-based biomarker and drug discovery company, having served as its first CEO from inception in 2000 until late 2002 when he assumed the role of Chief Scientific Officer. Dr. Hearl raised seed and Series A & B funding for CGI (~$5 million in cash/debt) and acquired the Dynex Technologies division of Thermo Scientific in a leveraged acquisition deal. (Dynex was subsequently divested yielding a 10-fold return to the Company). He is also responsible 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 for HIV, HTLV-I and Hepatitis C. He later worked at Life Technologies Corporation (now part of Invitrogen) and directed the Immunodetection Group. His lab developed a number of innovative antibody-based detection kits and reagents. He moved into scientific management when he became the Director of R&D at Kirkegaard & Perry Laboratories, 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 founding employees of the Company. Dr. Heiland is an experienced molecular biologist and holds multiple patents in the field of genomics. Prior to assuming the post as Vice President at ITI, Dr. Heiland led multiple research teams at Capital Genomix, Inc. developing and validating GeneSystem320™ and applying this technology to identify biomarkers 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 worked as a senior scientist in R&D at Kirkegaard & Perry Labs (KPL) where she spent four years as a project leader on development and commercialization of six major kits and she was responsible for the utilization of GS320™ with both cytokine and HIV model systems. She has facilitated the optimization of the GS320 assay and has been involved in work involving eukaryotic gene regulation since 1989. She has expertise in the fields of signal transduction, amphibian development, and gene regulation. Dr. Heiland is primary author on a number of publications that utilized extensive work with mRNA and cDNA and assays such as RT-PCR, RNAse Protection Assays, Northern Blotting, as well as, library cloning and screening. Dr. Heiland obtained her Ph.D. in molecular biology 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 was Senior Director of New Product Development at SeraCare Life Sciences, Gaithersburg, MD; prior to that, Dr. Coleman worked at Lonza Bioscience, Inc., Walkersville, MD where he held leadership roles in Product Development and Quality Control. At ITI, Dr. Coleman will have an assortment of responsibilities 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 has more than 40 publications and 26 issued patents. He obtained his BA degree from Rutgers-Newark and a 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 from raising capital, financial reporting, investor relations, banking, taxation, mergers and acquisitions to financial planning and analysis, and accounting operations. Most recently, he was CFO of OpGen where he was responsible for all financial functions at the company. Prior to joining OpGen, Mr. Winzer served as executive vice president and CFO for Avalon Pharmaceuticals, Inc., a biotechnology company developing targeted therapeutics for oncology. Prior to Avalon, Eric was with Life Technologies Corporation (formerly Invitrogen Corporation), a provider of life science technologies for disease research and drug discovery, where he served as senior 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 economics and 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 director and consultant. As Chief Executive for McDonald & Associates, a strategic and transactional global health care advisory 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 to companies in these sectors, and also advises many Boards and private investors of several global client companies during and following assignments. Mr. McDonald was interim President and CEO of TSO3 from April-October 2008, a publicly traded Canadian medical device company, following election by TSO3 Board of Directors prior to the AGM meeting following the abrupt resignation of the co-founder/CEO. He was responsible for revising the company’s development and marketing 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, subsequently joined 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 Board following his election in 2011. He currently serves on the Advisory Board of Zeus Scientific, a private US-based IVD company. Previously, he was also Executive Director and Principal with The Sage Group, a global healthcare consultancy. He was directly involved in over 150 client assignments encompassing strategic assessment, technology development, 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, and market assessments and analysis involving diverse technologies and products in healthcare. He also served as Interim Executive for many client assignments. Prior to consulting to the industry, Mr. McDonald was President/CEO of Mast/Hitachi, the second largest global allergy diagnostic company, with additional responsibility for heading an executive staff within Hitachi Chemical corporate for assessment of new technology, acquisitions and internal technology development within its life sciences 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 European corporation. Mr. McDonald was General Manager and Executive Board Member of Boots-Celltech, a joint venture between Boots Pharmaceutical and Celltech Limited in the UK, and was instrumental in negotiating a sale of the companyâ&#x20AC;&#x2122;s products and technologies to two separate US companies. His corporate experience was gained in executive positions with the Ortho Diagnostics division of Johnson & Johnson and multiple operating divisions of American Hospital Supply (now Baxter International and Siemens Healthcare). Mr. McDonaldâ&#x20AC;&#x2122;s broad health care business expertise has been augmented through participation in international strategic management schools in France, Japan, and the United States at Wharton Business School and Columbia University. Mr. McDonald's academic accomplishments include an MD/PhD program at the University of Kentucky, Albert Chandler Medical School, an M.S. in Microbiology and Genetics and a B.S. in Biochemistry and pre-med from The University of Southern Mississippi. Bruce F. Mackler, Ph.D., J.D. Dr. Macklerâ&#x20AC;&#x2122;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 (recombinant proteins, genomics, allergens, active and passive vaccines, cell and gene therapy). Dr. Mackler has advised financial groups on integrated FDA, technical and business issues, when performing due diligence assessments on biomedical opportunities prior to their making initial investments and during bridging. These due diligence activities integrate his business acumen from working in sales/manufacturing in a family textile business, owning and managing several bioservice businesses and being a university/NIH researcher for 15 years, prior to his 27 years 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 100 published scientific papers and abstracts in immunology, immunopathology, allergy and diseases, as well as numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues. Dr. Mackler has 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 regulatory documents (e.g., INDs/NDAs, DMFs, and BLAs, Accelerated and Fast Track Approvals, as well as Orphan Drug Designation applications). He has, as a U.S. agent, held IDEs/INDs and secured Treatment-INDs with substantial cost reimbursement, and has written successful Orphan Drug Development/SBIR grants and Designation applications; therefore, he is familiar with the nuances of these regulatory procedures. Dr. Mackler received his J.D. from the South Texas College of Law (magna cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from the Pennsylvania State University (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 angel groups. Mr. Rudnick’s entrepreneurial career includes a number of startups, three of which grew to over $60 million 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 and has held a number of other board positions – both commercial and not-for-profit – throughout his career. With 36 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 to Fortune 50. Mr. Rudnick has substantial experience investing and guiding investments in entrepreneurial companies, he has led capital formation totaling more than $530 million in the past ten years and $3B during the last 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 life sciences companies. Bernie received his BS in Biochemistry from Pennsylvania State University and an MBA from Northwood 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 Capital Genomix, Inc. From 1997 to 2001, he served as the President and CEO of DYNEX Technologies, Inc., which was a wholly 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 million public company (TOC), and a worldwide leader in the development, manufacturing and marketing of FTIR microscopes, accessories and software for the analytical instrumentation market. Mr. Wishart received his BS degree 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 Greenhouse of 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 Life Sciences Greenhouse, Dr. Thiboutot was President of RT Consultants, Inc. which provided technical, equipment procurement, and facility design consulting services to the US and EU pharmaceutical industry. Among his other employers 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 the Massachusetts College of Pharmacy, and has been active in numerous U.S. and International pharmaceutical trade organizations 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 Operations The 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 now located 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 Road facility adding office and laboratory space. In 2015, the Company will be seeking to expand its manufacturing and office facilities in Pennsylvania to increase our production and process development capabilities.
Capitalization & Ownership ITI is a privately–held C corporation chartered in the State of Delaware. The Company has issued approximately 9,756,477 shares of Common Stock and 1,535,245 of Preferred Series A Stock (which converts to 2 shares of Common) as of the date of this Plan. The top 10 Shareholders own approximately 49% of the Company which includes the Hummel Family Trust, the Trisiras Group the Life Sciences Greenhouse, the Jordan Family Office, the Rathmann Family Office and the CEO, William Hearl.
Financial Overview THE PROJECTIONS COVERED IN THE FINANCIAL PLAN AND PROJECTIONS ATTACHED HERETO ARE SUBJECT TO RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FORM THOSE PROJECTED AND DO NOT CONSTITUTE A REPRESENTATION OR WARRANTY OF PERFORMANCE BY ANY PARTY HERETO. Immunomic Therapeutics has operated a highly capital efficient business since its inception, having raised approximately $11 million through 2013. In 2014, the Company closed on October 8 a Series A Preferred financing resulting 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 in 2014 to support the further development of JRC-LAMP-vax. This included manufacture of a new lot of vaccine for use in clinical studies both in the U.S. and in Japan. The Company also made a significant investment in filing with the PMDA (the Japanese regulatory agency) to conduct a clinical study in Japan either in late 2014 or early 2015. 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 health division, Elanco. Due to multiple factors during the collaborative development phase, both companies determined to end the collaboration and in March 2015, Elanco returned the license, all rights to LAMP in Animal Health and all data related to product development to Immunomic Therapeutics. As a result, future revenues from milestones 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 Total Year 2012
Actual for Total Year 2013
Actual Total Year 2014
Pro Forma Total Year 2015
Revenues Elanco Grants Astellas CMC R&D Reimbursement Licensing Revenue
$
Total Revenue COGS Gross Profit
$ $ $
725,266 208,457 516,809
$ $ $
EXPENSES: Clinical Expense
$
651,234
R&D
$
Sales/Mktg. G&A
725,266
$
121,950
$ $
76,975 40,901
121,950 18,326 103,624
$ $ $
117,876 31,413 86,463
$
556,762
$
2,126,682
$
1,814,475
591,335
$
746,325
$
664,034
$
953,687
$
29,000
$
27,434
$
90,117
$
90,000
$
1,279,670
$
1,268,435
$
2,016,750
$
3,384,833
$
142,731
$
375,224
$
1,175,0001
Process Development
$ 1,555,217 $ 2,050,000 $ 10,000,000 $ 5,000,000 $ 18,605,217 $ 255,217 $ 18,350,000
Licensing Fees
$
50,000
$
378,834
$
179,757
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
Net Income (Loss)
$
(2,227,107)
$ (3,344,391)
$ (5,976,072)
$ 1,878,0002
$
8,688,481
Notes: 1. 2.
2015 reflects one-time expenses of payments to License Holders related to Astellas transaction. 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 & HQ 1214 Research Blvd, Suite 2016 Hummelstown, PA 17036
Rockville Facility Research & Development & Admin 15010 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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April 2015