TapImmune, Inc. (OTCQB: TPIV, Target Price: $2.25)
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- Alicia McCarthy
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1 Equity Update () TapImmune, Inc. (OTCQB: TPIV, Target Price: $2.25) Based in Jacksonville, FL, TapImmune, Inc. (OTCQB: TPIV) is a clinical-stage immune-oncology company specializing in the development of innovative technologies for the treatment of cancer and metastatic disease. TPIV has made considerable clinical and financial progress over the last year, including the completion of positive Phase I clinical trials in breast and ovarian cancer at the Mayo Clinic, which showed that its TPV-100 and TPV-200 vaccines were safe and well tolerated, and demonstrated robust cellular immune responses in over 90% of evaluable patients. Since the results, TPIV has announced multiple phase 2 clinical studies and was also granted an Orphan Drug Designation and received fast track designation from the FDA for TPIV 200 in ovarian cancer. On the corporate development front, TPIV also raised more than $10mn in new financing during 2015, which should cover the company s clinical development spending needs during Impressively, TPIV has been able to strike compelling deals with strategic partners to advance Phase 2 clinical studies, from which we expect the company to disclose insightful data over the next months. Investment Highlights Large market opportunity for TPIV s immunotherapy platform The company s lead candidate, TPIV-200, is a multi-epitope peptide vaccine that targets Folate Receptor Alpha, which is overexpressed in multiple cancers including over 90% of ovarian cancer cells. TPIV s platform immunotherapy technology is initially being explored as a potential therapy for ovarian, triple-negative breast, and Her2neu cancers, though the company believes it has potential to treat a number of cancels as a standalone treatment of in combination with other approved products. Although the company is clinical-stage, we note that the potential market for its products is vast, if it receives FDA approval. According to IMS Health, the global market for cancer drugs has eclipsed $100 billion per year in sales, and the cancer immunotherapy market is one of the fastest-growing segments of this market estimated to to reach $41 billion in major markets by 2020E, according to researchandmarkets.com. New Phase 2 clinical study with AstraZeneca to begin at Memorial Sloan Kettering Cancer Center in 2Q16 We have been impressed by the quality of collaborative partners announced by TPIV as it commences Phase 2 clinical studies for its lead candidate, TPIV-200. Most recently, TPIV announced a new Phase 2 clinical study of TPIV-200 for ovarian cancer that will be jointly funded with major pharmaceutical corporate AstraZeneca PLC (NYSE: AZN). TPIV and AstraZeneca will supply drug in a Phase 2 clinical study of its cancer vaccine, TPIV 200, in combination with AstraZeneca s durvalumab (MEDI4736), in a single arm, study at Memorial Sloan Kettering Cancer Center, commencing in 2Q16. This development follows an announcement in 2H15 that the company s longstanding research partner the Mayo Clinic had received a $13.3mn grant from the Department of Defense to fund a 280-patient Phase 2 clinical trial of TPIV-200 for breast cancer. In addition, TapImmune will conduct a companysponsored Phase 2 clinical study of TPIV-200 in Triple Negative Breast Cancer and file a new IND application with the FDA for HER2neu breast cancer in early 2017E. Accordingly, we expect to see significant clinical progress from TPIV during the next 24 months. Price target of $2.25 for TPIV TPIV continues to make substantial clinical progress, and we are impressed by the quality of partners that the company has been able to attract in its Phase 2 studies. We are updating our price target at this time for TPIV to reflect the current share count and warrants outstanding, which is higher than our original valuation. If achieved, the price target of $2.25 represents upside potential of 268.9% from the recent price of $0.61. Stock Details (5/11/16) OTCQB: Sector / Industry SeeThruEquity, LLC. Important disclosures appear at the back of this report. 1 P age TPIV Price target $2.25 Recent share price $0.61 Shares o/s (mn) 71.0 Market cap (in $mn) week high/low $1.71 / 0.24 Source: Thomson Reuters, SeeThruEquity Research Key Financial ($mn, unless specified) FY13 FY14 FY15 Revenues EBITDA (3.3) (3.4) (6.2) EBIT (3.3) (3.4) (6.2) Net Income (5.5) (30.9) (34.1) EPS ($) (4.87) (2.00) (0.78) Source: SeeThruEquity Research Key Ratios FY13 FY14 FY15 Gross margin (%) NM NM NM Operating Margin (%) NM NM NM EBITDA margin (%) NM NM NM Net margin (%) NM NM NM P/Revenue (x) NM NM NM EV/EBITDA (x) NM NM NM EV/Revenue (x) NM NM NM Source: SeeThruEquity Research Share Performance, LTM Sep-15 Dec-15 Mar-16 Source: Thomson Reuters
2 ANNUAL FINANCIAL SUMMARY Figure 1. Income Statement Summary Figures in $ 000, unless specified FY2015 FY2014 Operating Expenses General & Administrative Expenses 4,448 3,182 YoY change 39.8% N/A Research & Development 1, YoY change 805.4% N/A Total Operating Expenses 6,159 3,371 YoY change 82.71% N/A Operating Income (Loss) -6,159-3,371 Operating Margin N/A N/A Interest Expense Other Items -27,897-27,429 Net Income -34,066-30,883 Foreign Exchange Comprehensive Income -34,066-30,825 YoY change N/A N/A EPS - Basic & Diluted Avg Shares in Period 43,947 15,465 Source: Company Filings, SeeThruEquity Research Financing helps balance sheet and eases liquidity concerns for TPIV; results broadly in line with our thinking TPIV s FY2015 results came in with operating expenses of $6.2mn, which was roughly in line with our thinking. Given that the company is clinical stage, we did not expect TPIC to generate revenue during 2015E TPIV reported GAAP EPS of ($0.78) for the year, versus our last estimate of ($0.70). The majority of the loss was due to non-operating items including a change in the valuation of derivative liabilities related to warrants from financing activities. TPIV had 71.0mn shares outstanding at the time of its 10-K filing, versus 62.9mn at the time of our last note on the company and 16.1mn at the time of our initiation in We attribute the increase to the warrant financing completed last year, as discussed in more detail in our Sept 2015 note. Balance Sheet in Better Shape: Importantly, TPIV evinced substantial progress on its balance sheet during 2015 a key area for any clinical stage company in the industry. TPIV ended the year with cash on hand of $6.6mn and current liabilities excluding derivative liabilities from its warrants - of $1.5mn. $13.3mn DoD grant a hidden research asset: We note, also that the company s collaborative research partner The Mayo Clinic was awarded a $13.3mn grant by the Department of Defense, which is expected to fully fund a Phase II clinical trial evaluating TPIV s TPIV 200 for Triple Negative Breast Cancer. Clearly the grant reduces the potential funding needs in this area and continues to advance the pipeline. We continue to see TPIV s balance sheet as an item to watch, given the costs required to advance its clinical pipeline. The company used $4.3mn in operating cash flow in 2015, while raising $10.8mn in new capital through share issuances and the exercise of warrants. While acknowledging that the company s recent financing has taken place below market prices and the price target in this report, we note that TPIV has received a going concern qualification from its independent auditors, Marcum LLP, and the financing substantially ease liquidity pressure on TPIV while it pursues its clinical pathway. With 54.2mn warrants outstanding at the end of December 2016, the company has potential to access more than $30mn of additional funding, should these be exercised SeeThruEquity, LLC. Important disclosures appear at the back of this report. 2 P age
3 Multiple Phase 2 clinical collaborations for TPIV-200 inlcuding Memorial Sloan Kettering Cancer Institute, AstraZeneca and Department of Defense sponsored trial at Mayo Clinic On April 21, 2016, TPIV announced a collaboration with major pharmaceutical player AstraZeneca PLC (NYSE: AZN) and Memorial Sloan Kettering Cancer Institute to commence a jointly-funded Phase 2 clinical study of its cancer vaccine, TPIV 200, in combination with AstraZeneca s durvalumab (MEDI4736). TPIV obtains Orphan Drug / Fast Track Designation for TPIV-200 for ovarian cancer: Importantly TPIV will provide recently obtained an Orphan Drug Designation for ovarian cancer from the FDA. The purpose of the study will be to examine how TPIV 200, which is a multi-epitope peptide vaccine that targets Folate Receptor Alpha (FRα), performs in combination with durvalumab (MEDI4736), an anti-pd-l1 antibody, for patients with platinum-resistant ovarian cancer. The jointly-funded Phase 2 clinical study will be conducted at Memorial Sloan Kettering Cancer Center in New York. It is expected to be a single arm Phase 2 trial, which will include 40 women with high-grade ovarian, tubal, or primary peritoneal carcinomas, who have progressed within 6 months of their most recent platinum chemotherapy. 2Q16 Expected start date: The study is expected to commence in during 2Q16, and will be led by Jason Konner, M.D. as Principal Investigator. The primary endpoint of the study is the overall response rate, with secondary endpoints being safety and immune correlation of FRα-specific immune responses with clinical efficacy. TPIV obtains Orphan Drug / Fast Track Designation for TPIV-200 for ovarian cancer. TPIV plans to start a company sponsored Phase 2 study as maintenance therapy in platinum sensitive ovarian cancer in support of the recent fast track designation from the FDA. The study is expected to start in TPIV provides TPIV-200 for Triple Negative Breast Cancer Trial at Mayo Clinic: 280 patient trial, sponsored by Department of Defense, expected to start in 3Q16 We see these announcements as providing strong independent support for the potential therapeutic use of TPIV-200, especially considering that TPIV s announcement stated that the clinical studies in ovarian cancer will be jointly-funded by AstraZeneca and the clinical study in triple negative breast cancer trial completely funded by Department of Defense through a grant to the Mayo Clinic. TPIV completes GMP manufacturing for use in Mayo Clinic, Memorial Sloan Kettering Studies TPIV also recently announced that it had completed the formulation development, scale-up, GMP (Good Manufacturing Practice) manufacturing, and the release of TPIV-200, the company s lead therapeutic candidate for breast and ovarian cancer. The manufactured product contains five peptide antigens freeze dried in a single vial manufacture, and can be used in the company s 280-patient, Phase 2 clinical trial with the Mayo Clinic for breast cancer, fully funded by a $13.3mn Department of Defense grant, as well as TPIV s own Phase 2 clinical study for triple-negative breast cancer, and the ovarian cancer study taking place at the Memorial Sloan Kettering Cancer Center. We note that TPIV and the Mayo Clinic announced positive Phase 1 clinical data from the Folate Receptor Alpha trial in triple negative breast and ovarian cancer in 2H15, which demonstrated the experimental therapy was safe, welltolerated and provided a robust immune response in 19 out of 20 patients. With three Phase 2 trials / studies commencing in 2016, we expect continued updates from the company over the next months, including an updated on additional IND applications to the FDA, which could serve as possible catalysts for the company or the company s potential partnership discussions. PolyStart a potential hidden gem in TPIV pipeline TPIV has announced plans to accelerate the preclinical development of novel DNA expression vector PolyStart for breast cancer. Patent claims on over-expression of antigens recently allowed by US Patent & Trademark Office SeeThruEquity, LLC. Important disclosures appear at the back of this report. 3 P age
4 Progress continues at TPIV; Price target moves to $2.25 on new share count TPIV has made nice progress over the last year on the clinical front while securing important financing to advance its pipeline and fund operations. Our price target moves to $2.25, which, if achieved, reflects upside potential of 268.9% from the recent price of $0.61. The company continues to advance its clinical pipeline and as well as strategic relationships with partners such as the Mayo Clinic. The primary reason for the new price target is that the share count has increased more than we originally anticipated in the initial valuation of the company. We also considered the potential impact of future funding from 52.1mn warrants outstanding, which have a weighted average conversion price of $0.74. Management Team Glynn Wilson, Ph.D Chairman and Chief Executive Officer Glynn brings an extensive background of success in corporate management and product development with tenures in both major multinational pharmaceutical companies and start-up pharmaceutical/biotech organizations. Dr. Wilson s former positions include Head of Drug Delivery at SmithKline Beecham Pharmaceuticals, Research Area Head in Advanced Drug Delivery at Ciba-Geigy Pharmaceuticals, and President and co-founder of Auriga Pharmaceuticals. As Executive Vice President of R&D at Tacora Corporation he was responsible for merging the Company with Access Pharmaceuticals. He is a recognized leader in the development of drug delivery systems. Glynn has a Ph.D. in Biochemistry and conducted medical research at The Rockefeller University, New York. He has been on the Board of TapImmune for 5 years. Patrick D. Yeramian, MD Consulting Medical Director Dr. Patrick Yeramian has over 25 years of experience in the pharmaceutical industry. He has supervised the clinical development of new drugs, biopharmaceuticals, cellular therapy agents, and vaccines as well as having held a prominent role in the approval of several new drug (metronidazole Flagyl MR ), biological (interferon alpha Multiferon, nafarelin Synarel ) and device (Inerpan ) applications in the US in the EC and the granting of over 20 successful INDs and IMPDs. Dr Yeramian is currently the Medical Director of the Vaccine and Gene Therapy Institute, Florida. For the past 10 years, Dr. Yeramian has been a consulting Medical Director for emerging biotechnology companies in the areas of regulatory strategy, translational research, and early phase clinical trials. Previously he served as Chief Medical Officer at Viragen, Inc. where he was responsible for development of global clinical and regulatory strategies and for implementation of clinical programs worldwide. Earlier Dr. Yeramian also served as Director of clinical research at GD Searle where he supervised the clinical programs for antibiotics, antivirals, sepsis/thrombosis, and cancer vaccines. Dr. Yeramian holds a Medical Degree from the University of Paris together with a Master of Clinical Science in experimental oncology and a Graduate Degree in molecular virology. He also earned a Master of Business Administration from Rutgers University. He completed his medical residency in oncology at the Saint-Louis Hospital in Paris. Robert Z. Florkiewicz Sr. Director of Molecular Biology & Virology Dr Florkiewicz has experience in both academic and biotechnology environments. Most recently he conducted research on human embryonic stem-cell based therapies at the University of Washington. He was the Director of Cellular and Molecular Biology and co-founder of Ciblex Corporation, a spin-out from his laboratory at the Scripps Institute, San Diego. He was a patent agent at Seed Intellectual Law Group in Seattle and at ID Biomedical where he managed the Company s intellectual property portfolio prior to and through its acquisition by GlaxoSmithKline. He has a Ph.D. in Molecular and Development Biology from the University of Arizona (focusing on the molecular biology of various RNA viruses) and was a postdoctoral fellow at the Salk Institute (focusing on the intracellular trafficking of proteins encoded by vesicular stomatitis virus). As a Research Scientist at Synergen, Inc. he helped establish the viral vector and animal cell expression group, and also discovered novel molecular mechanisms modulating FGF2 gene expression. John Bonfiglio, Ph.D., MBA Strategic Advisor, Director John Bonfiglio, Ph.D., MBA is a highly successful Biotech CEO with broad experience in corporate strategy and financing, market interactions and business development. He was most recently President and CEO of Oragenics where he refocused the company and raised over $29 million dollars in the public markets while positioning the company for a successful re-listing on the NYSE: MKT stock exchange. He was formerly President and CEO of Argos Therapeutics where he raised over $35 million dollars for the Company and led the company in a successful Phase 2 study in renal cell carcinoma. As President and CEO of the Immune Response Corporation he was responsible for turning the Company around through improved therapeutic focus, capital raising (over $50 million) and improved investor relations resulting in a significant increase in stock price and shareholder value. John was also President and CEO of Peregrine Pharmaceuticals and Director of Business Development at Baxter Healthcare Corporation s Immunotherapy Division. John has a Ph.D from the University of California, San Diego, and an MBA from Pepperdine University SeeThruEquity, LLC. Important disclosures appear at the back of this report. 4 P age
5 About TapImmune, Inc. TapImmune Inc. is an immune-oncology company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients' killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Tapimmune.com SeeThruEquity, LLC. Important disclosures appear at the back of this report. 5 P age
6 CONTACT: Ajay Tandon Director of Research SeeThruEquity, LLC (646) DISCLOSURE: This report has been prepared and distributed by SeeThruEquity, LLC. This report is based on sources that we consider reliable, but we do not represent it is accurate or complete, and it should not be relied on as such. All information contained herein is subject to change without notice. This report is not an offer to sell or the solicitation of an offer to buy any security in any jurisdiction where such an offer or solicitation would be illegal. It does not constitute a personal recommendation or take into account the particular investment objectives, financial situations, or needs of individual clients. Clients should consider whether any information in this report is suitable for their particular circumstances and, if appropriate, seek professional advice, including tax advice. Statements included in this report may constitute forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand and the company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects, and internal issues. SeeThruEquity has not been compensated for the preparation of this report. SeeThruEquity and/or its affiliates may have a long position with respect to the publicly traded shares of the subject company covered in this report. SeeThruEquity, LLC is not a broker-dealer and does not generate any investment banking or commission-based revenue with respect to the securities of the company described herein. Our professionals may provide oral or written market commentary that reflects opinions that are contrary to the opinions expressed in this report. The price and value of the investment referred to in this report may fluctuate. Past performance is not a guide to future performance, future returns are not guaranteed, and a loss of original capital may occur. Certain transactions, including those involving futures, options, and other derivatives, give rise to substantial risk and are not suitable for all investors. Our report is disseminated primarily electronically, and, in some cases, in printed form. Electronic report is simultaneously available to all recipients in any form. The information contained in this report is not incorporated into the contents of our website and should be read independently thereof. Copyright SeeThruEquity, LLC. No part of this material may be (i) copied, photocopied or duplicated in any for by any means or (ii) redistributed without the prior written consent of SeeThruEquity, LLC SeeThruEquity, LLC. Important disclosures appear at the back of this report. 6 P age
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