Announcement PDF INVION CORPORATE PRESENTATION February 2018 1 DISCLAIMERS This investor presentation (Presentation) has been prepared by Invion Limited (the Company or Invion). It contains general information about the Company as at the date of this Presentation and the proposed non-renounceable pro-rata entitlement offer to be made by the Company of new fully-paid ordinary shares in the Company (New Shares) to eligible shareholders of the Company under section 708AA of the Corporations Act 2001 (Cth) (Corporations Act) (as modified by ASIC Corporations (Non-Traditional Rights Issues) Instrument 2016/84) (Entitlement Offer). The information in this Presentation should not be considered to be comprehensive or to comprise all of the material which a shareholder or potential investor in the Company may require in order to determine whether to deal in shares. The information in this Presentation is of a general nature only and does not purport to be complete. This Presentation does not take into account the financial situation, investment objectives, tax situation or particular needs of any person and nothing contained in this Presentation constitutes investment, legal, tax or other advice, nor does it contain all the information which would be required in a disclosure document or prospectus prepared in accordance with the requirements of the Corporations Act. Readers or recipients of this Presentation should, before making any decisions in relation to their investment or potential investment in the Company, consider the appropriateness of the information having regard to their own objectives and financial situation and seek their own professional investment, legal and taxation advice appropriate to their particular circumstances. This Presentation is for information purposes only and does not constitute or form part of any offer, invitation, solicitation or recommendation to acquire, purchase, subscribe for, sell or otherwise dispose of, or issue, any entitlements or New Shares or any other financial product. Further, this Presentation does not constitute financial product or investment advice (nor tax, accounting or legal advice), nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any contract or investment decision. Eligible shareholders should consider this Presentation in conjunction with the information contained in the Entitlement Offer information booklet which has been lodged with ASX (Information Booklet), which has been lodged with ASX. Any eligible shareholder in Australia, New Zealand, Hong Kong or Singapore who wishes to participate in the Entitlement Offer should consider the Information Booklet before deciding whether to participate in the offer. Anyone who wishes to apply for New Shares should follow the instructions contained in the Information Booklet and accompanying personalised entitlement and acceptance form. This Presentation may not be released in in the United States. This Presentation does not constitute an offer to sell, or solicitation to an offer to buy securities in the United States or in any other jurisdiction which would be illegal. Entitlements and New Shares have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (U.S. Securities Act) or the securities act of any other state or other jurisdiction in the United States. Accordingly, the entitlements and New Shares may not be offered or sold, directly or indirectly, in the United States, unless they have been registered under the U.S. Securities Act, or are offered and sold in a transaction exempt from, or not subject to, the registration requirements of the U.S. Securities Act any other applicable state securities laws. The distribution of this Presentation in other jurisdictions outside Australia may also be restricted by law and any restrictions should be observed. Any failure to comply with such restrictions may constitute a violation of applicable securities laws. Certain statements in this Presentation are forward-looking statements. You can identify these statements by the fact that they use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “may”, “assume”, "should", "could", "predict", "propose", "forecast", "outlook" and words of similar import. Indications of, and guidance on, future earnings and financial position and performance are also forward-looking statements. Forwardlooking information may include, but is not limited to, the success of clinical trials, the outcome of regulatory approvals or the future outlook in commercialising products. No representation, warranty or assurance (express or implied) is given or made by the Company that the forward-looking statements contained in this Presentation are accurate, complete, reliable or adequate or that they will be achieved or prove to be correct. Subject to any continuing obligation under applicable law or relevant listing rules of the ASX, the Company disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements in this Presentation to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statements are based. Nothing in this Presentation shall under any circumstances create an implication that there has been no change in the affairs of the Company since the date of this Presentation. To the maximum extent permitted by law, the Company, the underwriter and their respective related bodies corporate and affiliates, and their respective directors, officers, partners, employees, agents and advisers expressly disclaim all liability (including without limitation, liability for negligence) for any direct or indirect loss or damage which may be suffered by any person in relation to, and take no responsibility for, any information in this Presentation or any error or omission therefrom, and make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of the information contained in this Presentation. Determination of eligibility of investors for the purpose of the Entitlement Offer is determined by reference to a number of matters, including legal requirements and the discretion of the Company and the underwriter. The Company and the underwriter disclaim any liability in respect of the exercise or otherwise of that discretion, to the maximum extent permitted by law. By attending an investor presentation or briefing, or by accepting, accessing or reviewing this Presentation, you acknowledge and agree to the terms set out in this disclaimer. 2 R&D Services Agreement: Invion will conduct clinical development of Photosoft™ globally, leveraging the Company’s expertise. The Cho Group will provide nondilutive funding for R&D and clinical trials as part of a global development strategy for the asset STRATEGIC TRANSACTION APPROVED BY SHAREHOLDERS AT 2017 AGM 1 3 2 Exclusive Distribution and Licence Agreement: Invion has exclusivity in Australia and New Zealand to commercialise and distribute Photosoft™ for the treatment of cancers. 3 Underwriting Agreement: The Cho Group will fully underwrite Rights Issue to raise up to $2.5M WHAT IS PHOTO DYNAMIC THERAPY (PDT)? Use of light to destroy cancerous cells or other abnormal tissue When exposed to specific wavelengths of light, photosensitizing agents produce a form of oxygen that causes destruction of nearby cells without damaging nearby tissue Wavelength determines how far the light can travel into the body 4 WHAT IS PHOTODYNAMIC THERAPY? Photodynamic therapy (PDT) was developed at Roswell Park Cancer Institute (RPCI) in the late 1970s by Thomas Dougherty, PhD PDT is a treatment that uses a light sensitive drug – a photosensitiser - and non-thermal visible red light, typically generated by a laser When photosensitisers are exposed to a specific wavelength of light, they produce a form of oxygen that causes an almost immediate destruction of nearby cells without permanently damaging surrounding tissue Each photosensitising agent is activated by light of a specific wavelength. Wavelength determines how far the light can travel into the body https://www.roswellpark.org/patients/treatment-services/innovative-treatments/photodynamic-therapy https://www.cancer.gov/about-cancer/treatment/types/surgery/photodynamic-fact-sheet 5 1 HOW PDT WORKS 2 3 4 6 Photosensitizing agent is taken (by mouth) or given (intravenously) The agent circulates through the body and concentrates at the site of the tumour Light of specific wavelengths is shone on the body which activates the reaction in the tumour The tumour is selectively destroyed PDT MECHANISM OF ACTION PHOTODYNAMIC THERAPY (PDT) uses non-toxic photosensitisers and harmless visible light in combination with oxygen to produce cytotoxic reactive oxygen species that kill malignant cells by apoptosis and/or necrosis, shut down the tumour microvasculature and stimulate the host immune system. In contrast to surgery, radiotherapy and chemotherapy that are mostly immunosuppressive, PDT causes acute inflammation, expression of heat-shock proteins, invasion and infiltration of the tumour by leukocytes, and might increase the presentation of tumour-derived antigens to T cells. Castano et al. 2006. ‘Photodynamic therapy and anti-tumour immunity’. Nat Rev Cancer Jul;6(7):535-45. 7 PDT IN PRACTICE PDT IS USUALLY PERFORMED AS AN OUTPATIENT PROCEDURE There are a number of clinics throughout Australia that offer PDT therapy for the treatment of superficial skin cancers, and sunspots, including solar keratoses PDT may be repeated and may be used with other therapies, such as surgery, radiation therapy, or chemotherapy PDT is non-invasive and has lower negative side effects than other therapies 8 HISTORY OF PHOTODYNAMIC THERAPY 1903 1904 1930 1942 1958 Nobel Prize N. Finsen: Light therapy for skin conditions Von Tappeiner: PD reaction first shown Nobel Prize H. Fischer: Porphyrins description Porphrins: First used in treatments Light Bed therapy for Neonatal Jaundice 9 1971-85 Dougherty: Photofrin therapy Russian and Chinese PDT developments NASA & RSA 1990 2006 Windahl et al. (Denmark): PDT for local prostate cancer Moore & Emberton (England): Interstitial prostate PDT 10 PDT therapy became ‘mainstream’ in 1995 with the FDA approval of Photofrin (porfimer sodium) for treatment of esophageal cancer Variants of Photofrin were subsequently developed in clinical trials Tended to remain in the body for long periods HOWEVER FIRST GENERATION PDT HAD PROBLEMS: FIRST GENERATION PHOTOSENSITIZERS Fat solubility Does not absorb longer wavelengths so treatment depth was limited Leading to limited effectiveness and applicability 11 Largely chlorophyll based Strong absorption and longer wavelengths allowing deeper penetration of tissues Water soluble with good tissue distribution SECOND GENERATION PHOTOSENSITIZERS BETTER TUMOR SPECIFICITY 12 Low circulation times so patients are not left vulnerable to sunlight damage Different chemistry RESEARCH OUTPUT: MD ANDERSON CENTRE Clinical studies revealed that PDT can be curative, particularly in early stage tumors. It can prolong survival in patients with inoperable cancers and significantly improve quality of life. Minimal normal tissue toxicity, negligible systemic effects, greatly reduced long-term morbidity, lack of intrinsic or acquired resistance mechanisms, and excellent cosmetic as well as organ function-sparing effects of this treatment make it a valuable therapeutic option for combination treatments. With a number of recent technological improvements, PDT has the potential to become integrated into the mainstream of cancer treatment. Agostinis, P., Berg, K., Cengel, K. A., Foster, T. H., Girotti, A. W., Gollnick, S. O., ... Golab, J. (2011). Photodynamic therapy of cancer: An update. CA Cancer Journal for Clinicians, 61(4), 250-281. DOI: 10.3322/caac.20114 13 NEW WAVE OF INTEREST WITH TOOKAD STEBA BIOTECH CONDUCTED PH III IN 208 PATIENTS WITH LOW-RISK PROSTATE CANCER: participants who had disease progression at month 24: men who had a negative prostate biopsy result at 24 months post treatment: TOOKAD GROUP ACTIVE SURVEILLANCE GROUP (P<0·0001) 28% 58% “Localised, low-risk prostate cancer can be treated in a way that not only preserves genitourinary function but also results in a lower progression rate, a greater chance of being declared disease-free, and a reduction in need for whole-gland radical therapy in the form of surgery or radiotherapy compared with active surveillance” May allow more men to consider a tissuepreserving approach and defer or avoid radical therapy. 49% Tookad granted EMA approval, November 2017 14% Azzouzi, Abdel-Rahmène et al. (2016) Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer. The Lancet Oncology (18:2 181–191) 14 NEW GENERATION PHOTO DYNAMIC THERAPY: PHOTOSOFT™ Invion has licensed an asset based on patented PDT agent Photosoft™ Targeted to address limitations of 1st Generation PDT therapies Uses a laser light activation method based on a short, pulsating Near Infrared (NIR) wavelengths High photodynamic efficiency combined with NIR peaks of absorption NIR light therapy allows more effective whole-ofbody systemic treatment that can target circulating cancer cells as well as deeply seated tumours 15 PHOTOSOFT™ Chlorophyll-based PDT photosensitiser Complex of chlorin and chlorophyllin ACTIVATES AT MULTIPLE SENSITIVITY RANGES ACROSS A BROAD SPECTRUM 16 CURRENTLY AVAILABLE THERAPIES PHOTOSOFT™ ADVANTAGES PHOTOSOFT™ 1 Activation at multiple ranges allows deeper tissue penetration for the light source Water soluble Good bioavailability – can be administered sublingually and intravenously 2 Chlorin-e6 and Chlorophyllin-A are used Positive immune response demonstrated in Phase I clinical trials 17 1ST GENERATION VS PHOTOSOFT™ LIMITATION 1ST GENERATION PDT PHOTOSOFT™ CLEARANCE TIME 2 to 3 months clearance time. This causes extreme light sensitivity and patients are generally required to stay indoors. Fast body clearance time from normal cells and tissue structures as well as organs. Combined with high cancer cell selectivity allows patients to safely walk in the sunlight. SELECTIVITY FOR CANCER CELLS Low cancer cell selectivity therefore binds / penetrates non- cancer cells. Treatment requires endoscopic intervention with laser light directed through a fibre optic toward the tumour to avoid healthy cells. Highly selective only accumulating in cancer cells therefore the light activation can be safely provided over the whole body to treat every area affected by cancer. TOXICITY Some 1st generation PDT agents are derived from synthetic materials that are toxic. Photosoft is chlorophyll-based, derived form plants. DEPTH OF LIGHT PENETRATION Limited application and only used for surface tumours as the agent activation light is able to penetrate between 0.5 and 3 cm depth. Photosoft is activated with specific high frequency light able to penetrate through solid tissues and bone to deeply seated tumours. SINGLET OXYGEN YIELD Generate a low level of singlet oxygen release so effectiveness to kill cancer cells is limited. Photosoft has photodynamic efficiency capable of producing a high level of singlet oxygen, resulting in more effective cancer cell damage and death. CANCER CELL PENETRATION Oil based photo-sensitizer agents have low membrane permeation properties causing them to be weakly absorbed across the cell membrane. Photosoft possesses both hydrophilic (water-loving) and lipophylic (fatloving) properties enabling the agent to penetrate cancer cell membrane and accumulate in high concentration inside the cancer cell increasing damage and cell death. 18 LOCALISED PROSTATE CANCER: THE STATE OF PLAY INCREASING NUMBERS OF MEN ARE CHOOSING ACTIVE SURVEILLANCE OVER SURGERY OR RADIOTHERAPY BECAUSE OF THE RISKS OF THESE TREATMENTS Active surveillance was ~6% of US patients 15 years ago, now 40% Surgery and radiotherapy are radical treatments associated with urinary incontinence (9-18% over 15 years), erectile dysfunction (87-94%) and poor bowel function (22-36%) Over 20,000 men are diagnosed each year in Australia and New Zealand at estimated lifetime cost of A$26,000 p.a. = large market opportunity 19 References: Nat Rev Urol. 2016 Apr; 13(4): 205–215; N Engl J Med. 2013 Jan 31;368(5):436-45; Prostate Cancer Foundation of Australia EARLY STUDIES OF PHOTOSOFT™ CONDUCTED IN AUSTRALIA PHASE I | PROSTATE CANCER 2013 2017 o Photosoft™ was administered to 68 prostate cancer patients by Urologist Donald Murphy and collaborators o A second Phase I was completed in 37 patients by Donald Murphy in collaboration with Monash University o Results for 26 patients that had been treated for >6 months were reported at the Urological Society of Australia and New Zealand meeting in Melbourne in April 2013 o Participants had localised treatment-naïve prostate cancer or were patients with local relapse o Half of patients had stable to decreasing PSA and half increasing PSA, while prostate size generally fell on assessment using diagnostic imaging o PSA levels were checked at three months post-treatment and found four of seven first-line patients registering stable PSA. None of the three relapse patients registered stable PSA. o Photosoft™ was safe and well-tolerated o A global reduction in prostate size was noted across the primary treatment group o A proteomics analysis of protein samples found in the urine of the patients found various immune-related biomarkers were upregulated, with high statistical significance (p<0.001) 20 A NEW WAVE: IMMUNOTHERAPY AND PDT 2013 Immune response is important in the control of tumour growth 2017 o Photosoft was administered to 68 prostate cancer patients by Urologist Donald Murphy and collaborators o A second Phase I was completed by Donald Murphy in collaboration with Monash University o Results for 26 patients that had been treated for >6 months were reported at the Urological Society of Australia and New Zealand meeting in Melbourne in April 2013 o Participants had localised treatment-naïve prostate cancer or were patients with local relapse o Half of patients had stable to decreasing PSA and half increasing PSA, while prostate size generally fell on assessment using diagnostic imaging Research in o Photosoft was safe and well-tolerated In vivo evidence PDT space o PSA levels were checked the at three months post-treatment and exists that found four of seven first-line patients registering stable PSA. is increasingly immunotherapy None of the three relapse patients registered stable PSA. considering the and PDT could o A global reduction in prostate size was noted across the primary immunological work well together treatment group implications o A proteomics analysis of protein samples found in the urine of the patients found various immune-related biomarkers were upregulated, with high statistical significance (p<0.001) 21 Epub 2011 Jan 24 References: Neoplasma. 2010;57(2):184-8; Photochem Photobiol Sci. 2011 May;10(5):681-8. doi: 10.1039/c0pp00315h. PHASE I PROSTATE CANCER DATA 86 proteins relating to immune responses were observed Proteins relating to certain immune response pathways are enriched and were significantly over-represented within the dataset 22 ADVANTAGES OF NGPDT ™ AND PHOTOSOFT The immune response observed by Murphy in the Phase I provides potential advantages over other water-soluble PDT therapies such as Tookad There is a growing body of knowledge that PDT has the potential to generate an anti-cancer immune response Tookad Ph III success and EMA submission brings PDT into the mainstream via wider research, medical application and potential commercial success PDT therapies target early-state treatment as non-invasive and repeatable 23 TARGETS Skin cancers including melanoma, squamous cell carcinoma & basal cell carcinoma PDT THERAPIES TARGET EARLY-STAGE TREATMENT AS NON-INVASIVE AND REPEATABLE Lung cancer Prostate or Ovarian cancer 24 Establish Scientific Advisory Board, and timing/ costs of Phase II/ III clinical trials in prostate cancer leading to approval submissions Explore short term opportunities for treatment of skin cancers and other disorders Develop ovarian cancer strategy as the next clinical opportunity for Photosoft™ 25 FIRST STEPS: FUNDED WITH NON-DILUTIVE CAPITAL ACQUISITION/ LICENSING OPPORTUNITIES INV103 (Cpn10) INV102 (Nadolol) INV104 (Zafirlukast) Current assets have completed programmed clinical development Management remains committed to licensing the assets 26 ENTITLEMENT OFFER DETAIL FULLY UNDERWRITTEN NON-RENOUNCEABLE ENTITLEMENT OFFER Entitlement Offer Ratio 8 for 27 Approximate amount raised $2.5 million CAPITAL STRUCTURE Current Shares on Issue 4,205,965,273 Entitlement Offer Shares 1,246,211,933 Post Entitlement Offer Shares on Issue 5,452,177,206 OFFER PRICE METRICS Offer Price $0.002 per share Closing Price 9 February 2018 / discount $0.028 / 92.86% TERP/ discount 27 $0.0225 / 91.11% KEY DATES This timetable is indicative only and subject to change. The Directors may vary these dates, in consultation with the Underwriter, subject to the Listing Rules. An extension of the Closing Date will delay the anticipated date for issue of the New Shares. The Directors also reserve the right not to proceed with the whole or part of the Entitlement Offer any time before the allotment and issue of the New Shares. In that event, the relevant Application Monies (without interest) will be returned in full to Applicants. The commencement of quotation of New Shares is subject to the discretion of ASX. Cooling off rights do not apply to an investment in New Shares. You cannot withdraw your application once it has been accepted. EVENT DATE Announcement of the Offer Monday, 12 February 2018 Record Date (7.00pm AEDT) Thursday, 15 February 2018 Information Booklet and Entitlement and Acceptance Form despatched Monday, 19 February 2018 Offer opens Monday, 19 February 2018 Closing date for acceptances under Offer (5.00pm AEDT) Thursday, 8 March 2018 Company notifies ASX of under subscriptions Tuesday, 13 March 2018 Allotment of New Shares under the Offer Thursday, 15 March 2018 Normal ASX trading for New Shares issued under the Entitlement Offer commences Despatch of holding statements for New Shares issued under the Offer 28 Friday, 16 March 2018 Monday, 19 March 2018 USE OF FUNDS $ Working capital to fund current and forward operations 0.9M Repayment of current liabilities: outstanding loans and all accrued interest 1.6M TOTAL 2.5M 29 KEY RISKS This section sets out some of the key risks to an investment in Invion Limited (Invion or Company). The risks in this section are not, and should not be considered to be or relied on as, an exhaustive list of the risks relevant to an investment in Invion. The risks are general in nature and regard has not been had to the investment objectives, financial situation or particular needs or any investor. Before investing or increasing your investment in Invion, you should consider whether this investment is suitable for you having regard to publicly available information and your personal circumstances and following consultation with your professional advisers. 30 KEY RISKS NGPDT licence Funding risk Clinical trial risk Invion has entered into an exclusive distribution and licence agreement with RMW Cho Group in relation to, amongst other things, the distribution and commercialisation of the Next Generation PDT (NGPDT) technology. Failure by Invion to comply with the terms of the agreement may result in the breakdown of Invion’s relationship with RMW Cho Group or in the termination of the agreement, which could adversely impact on Invion’s financial performance. Invion’s clinical trial costs relating to NGPDT will be fully funded by RMW Cho Group. However, there is no assurance that the Company will be able to raise further capital if and when it is required, or that the terms associated with raising that capital will be satisfactory to the Company. If Invion is unsuccessful in obtaining funds when they are required, Invion may need to delay or eliminate its research and development, commercialisation or manufacturing activities, or other aspects of its business, have to license or sell its technologies on unfavourable terms, or scale down or cease operations. If Invion raises funds by issuing shares or borrowing, the terms may not be favourable and may dilute the ownership of its shareholders. Invion’s ability to achieve profitability is dependent on its ability to complete successful clinical trials. The development of biomedical therapies is inherently risky and subject to factors beyond the Company’s control. The industry is highly regulated and reliant on the timely availability of clinical trial patients. Invion may be unable to secure necessary approvals from regulatory agencies and institutional bodies (clinics and hospitals) to conduct clinical trials. There is also no assurance that products developed using Invion’s technology will prove to be safe and efficacious in clinical trials, or that the regulatory approval to manufacture and market its products will be received. Clinical trials might also potentially expose Invion to product liability claims in the event its products in development have unexpected effects on clinical subjects. To the extent it is available on reasonable terms, Invion intends to maintain clinical trial insurance, however there is no guarantee such insurance will be held valid or be sufficient to cover any liability which may arise. 31 KEY RISKS Regulatory and reimbursement approvals Risk of delay Commercialisation of products Retention of key personnel and contract researchers The research, development, manufacture, marketing and sale of products using Invion’s technology are subject to varying degrees of regulation by a number of government authorities in Australia and overseas including but not limited to the FDA. Therapeutic products must undergo a comprehensive and highly regulated development and review process before receiving approval for marketing. The process includes the provision of clinical data relating to the quality, safety and efficacy of the products for their proposed use. Products may also be submitted for reimbursement approval for research and development costs, for example. The availability and timing of that reimbursement approval may have an impact upon the uptake and profitability of products in some jurisdictions. Furthermore, any of the products utilising Invion’s technology may be shown to be unsafe, non-efficacious, difficult or impossible to manufacture on a large scale, uneconomical to market, compete with superior products marketed by third parties or not be as attractive as alternative treatments. The Company may experience delay in achieving a number of critical milestones, including securing a commercial partner, completion of clinical trials, obtaining regulatory or reimbursement approvals, manufacturing, product launch and sales. Any material delays may impact adversely upon the Company, including the timing of any revenues under milestone or sales payments. Invion has not yet commercialised its technologies. In particular, the NPGDT technology has not been previously commercialised in Australia and New Zealand. There is no assurance that Invion will generate significant revenues or that Invion will ever achieve profitability. There is no assurance that Invion will attract and retain appropriate strategic partners or that any such partners will perform and meet commercialisation goals or make licensing payments. Because of the specialised nature of Invion’s business, Invion is highly dependent upon qualified, scientific, technical and managerial personnel. There is significant competition for qualified personnel in Invion’s business. The loss of the services of existing personnel, as well as the failure to recruit additional key scientific, technical, managerial and other personnel in a timely manner could harm Invion’s R&D programs and its business. 32 KEY RISKS Dependence on commercial partnering Intellectual property Commercial, manufacturing and distribution capability Invion will need to enter into one or more commercial partnering agreements to launch the marketing and sales of its lead products. The success of Invion’s partnering arrangements may depend on the resources devoted to them by itself or its industry partners. Collaborative agreements may be terminable by Invion’s partners. Non-performance, suspension or termination of agreements is likely to have a material and adverse impact on Invion’s business, financial condition and results of operations. Invion’s success will depend in part on its ability, and the ability of any licensor from whom Invion has obtains a licence from in respect of intellectually property, to obtain commercially valuable patent claims and to protect its intellectual property. Lodged patent applications may not result in issued patents or may take longer than expected for patents to issue, or the claims of any patents that are issued may not provide meaningful protection. Certain intellectual property may also not be capable of being legally protected. As legal regulations and standards relating to the validity and scope of patents continue to evolve, the degree of future protection for Invion’s proprietary rights is uncertain. Invion may incur substantial costs in asserting any patent or intellectual property rights and in defending legal action against it relating to intellectual pro