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- RISK FACTORS
The order in which the risks are presented does not reflect the likelihood of their occurrence or the magnitude of their potential impact on the Group’s business, results of operations, cash flows, financial condition and/or prospects. The risks mentioned herein could materialise individually or cumulatively. The information in this Section 2 is as of the date of this Prospectus.
Risks related to the business of Ultimovacs and the industry in which Ultimovacs operates
2.1.1.The Group is in an early stage of development and the Group’s clinical studies may not prove to be successful
Before obtaining regulatory approvals for the commercial sale of the Group’s product candidates, the Group must demonstrate, through lengthy, complex and expensive preclinical testing and clinical trials that its product candidates are both safe and effective for use in each target indication. Clinical testing is expensive, can take many years to complete and its outcome is inherently uncertain. Drug development involves moving drug candidates through research and extensive testing of activity and side effects in preclinical models before authorisation is given for further testing in humans in the clinical stage. The clinical stage is divided into consecutive phases with the aim to reveal the safety and efficacy of a drug candidate before an application for marketing authorisation can be filed with the relevant health authorities. The Group’s leading product candidate, UV1, is currently in an early phase of clinical development, which involves investigating side effects and indications of effectiveness in the relevant indications and combinations. The Group’s potential new product candidate(s) which builds on the technology acquired from Immuneed in 2018 is in a pre-clinical development phase. Failure can occur at any time during the development of these product candidates. Each individual development step is associated with the risk of failure. As a result, early stage drug candidates are associated with considerably higher risks of failure than later stage candidates. Moreover, the commencement and completion of clinical trials may be delayed by several factors, including but not limited to unforeseen safety issues, issues related to determination of dose, lack of effectiveness during clinical trials, slower than expected patient enrolment in clinical studies, unforeseen requirements from the regulatory agencies relating to clinical studies, and inability or unwillingness of medical investigators to follow the proposed clinical protocols. On average, five out of 5,000 drugs make it through the preclinical phase and historically, only one out of these five is approved by the U.S. Food and Drug Administration (the “FDA”) for marketing1. Moreover, only 2 of 10 marketed drugs return revenues that match or exceed R&D costs. It takes on average 12 years to develop a drug2.
The Group has limited clinical data and the results of preclinical studies and early clinical trials of the Group’s product candidates may not be predictive of the results of later-stage clinical trials. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. The Group cannot be certain that it will not face similar setbacks. Most product candidates that commence clinical trials are never approved as commercial products. For a variety of reasons, most attempts by other companies to develop peptide based cancer vaccines in the past have not been successful and have not received marketing approval. Should the Group’s clinical studies fail to adequately demonstrate the safety and efficacy of one or more of its product candidates, it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.2.The Group has incurred significant operating losses since inception and the Group expects to incur substantial and increasing losses in the foreseeable future
The Company is a clinical-stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.
The Group has financed its operations primarily through the sale of equity securities and public grants . Since its inception, most of the Group’s resources have been dedicated to the preclinical and clinical development of its product candidates. The size of the Group’s future losses will depend, in part, on the Group’s future expenses and its ability to generate revenue, if any. The Group has no products approved for commercial sale and has not generated any revenue from product sales to date and, it continues to incur significant research and development and other expenses related to its ongoing operations. As a result, the Group is not profitable and has incurred losses in each period since inception. In accordance with the Financial Statements, the Group had a total comprehensive loss of NOK 52.4 million in the financial year 2018 and a total comprehensive loss of NOK 32.8 million in the financial year 2017. The Group expects to continue to incur significant losses in the foreseeable future and it expects these losses to increase as it continues its research and development of, and seeks regulatory approvals for, its product candidates.
To become and remain profitable, the Group must succeed in developing and, eventually, commercialising products that generate revenues. This will require the Group to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of the Group’s products, discovering additional product candidates, obtaining regulatory approval for these product candidates and marketing and selling any products for which the Group may obtain regulatory approval. The Group may never succeed in these activities and, even if it does, may never generate revenue that is significant enough to achieve profitability. Should any of these risks materialise, it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.3.Obtaining regulatory approvals is required for commercialisation of the Group’s products
The Group does not have any products that have gained regulatory approval. Its business and future success depend on its ability to obtain regulatory approval of, and then successfully commercialise, its leading product candidate, UV1. This product is in an early stage of development. The Group’s ability to develop, obtain regulatory approval for, and successfully commercialise UV1 effectively will depend on several factors, including but not limited to the following:
- successful completion of the clinical trials;
- receipt of marketing approvals;
- establishing commercial manufacturing and supply arrangements;
- establishing a commercial infrastructure;
- acceptance of the product by patients, the medical community and third-party payers;
- establishing fair market share while competing with other therapies;
- successfully executing the Group’s pricing and reimbursement strategy;
- a continued acceptable safety and adverse event profile of the product following regulatory approval; and
- qualifying for, identifying, registering, maintaining, enforcing and defending intellectual property rights and claims covering the product.
The Group’s product candidate will require additional clinical and nonclinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before the Group can generate any revenue from product sales. The Group is not permitted to market or promote any of its product candidates before it receives regulatory approval from the FDA to market in the U.S., from the European Medicines Agency (the “EMA”) to market in Europe, as well as from equivalent regulatory authorities in other foreign jurisdictions. The Group may never receive such regulatory approval for any of its product candidates. If the Group is unable to develop or receive marketing approval for UV1 in a timely manner or at all, the Group could experience significant delays or an inability to commercialise UV1, which could materially and adversely affect the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.4.Any significant delay or failure in the conduct of clinical studies may adversely impact the Company’s ability to obtain regulatory approval for, and commercialise its current and future product candidates
The Group depends on collaboration with partners, medical institutions and laboratories to conduct clinical testing in compliance with requirements from appropriate regulatory authority in the country of use. The Group’s ability to complete clinical studies in a timely fashion, or at all, depends on several factors, including but not limited to the following:
- delays in the planning of future clinical studies;
- delays in the CMC (chemistry, manufacturing, control) and QA work related to drug substance and drug product inpresent or future clinical studies;
- delays in, or inability of, attracting and retaining highly qualified managerial, scientific and medical personnel to assist with the clinical studies;
- delays in obtaining, or failure to obtain, regulatory approval to commence clinical studies because of safety concerns of regulators relating to the Group’s product candidate or failure to follow regulatory guidelines regarding general safety issues;
- actions by regulators to place a proposed study on clinical hold or to temporarily or permanently stop a trial for a variety of reasons, principally due to safety concerns;
- delays in recruiting patients to participate in a clinical study and the rate of patient enrolment, which is itself a function of many factors, including size of the patients population, the proximity of patients to the clinical trial sites, the eligibility criteria for the study and the nature of the protocol;
- the inability to fully control experimental conditions;
- compliance of patients and investigators with the protocol and applicable regulations; failure of clinical studies andclinical investigators to be in compliance with relevant clinical protocol, or similar requirements in other countries;
- failure of third party clinical managers to satisfy their contractual duties, comply with regulations or meet expected deadlines;
- delays or failure in reaching agreement on acceptable terms with prospective study sites;
- the Group’s partners in clinical studies, the performance of which the Group cannot control;
- availability of the adjuvant GM-CSF;
- changes in the standard of care from initiation to completion of a clinical study; and
- determination by regulators that the clinical design is not adequate.Any significant delay or failure in the conduct of clinical studies may adversely impact the Group’s ability to obtain regulatoryapproval for, and commercialise, its current and future product candidates, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.5.The Group’s product candidates may cause undesirable side effects that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, if approved, and result in other significant negative consequences
Undesirable side effects caused by the Group’s product candidates could cause the Group or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA or comparable foreign regulatory authorities. Results of the Group’s clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.
If unacceptable side effects arise in the development of the Group’s product candidates, the Group could suspend or terminate its clinical trials or the FDA, EMA or comparable foreign regulatory authorities could order the Group to cease clinical trials or deny approval of the Group’s product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, side effects may not be appropriately recognized or managed by the treating medical staff.
Additionally, if one or more of the Group’s product candidates receives marketing approval, and the Group or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:
- regulatory authorities may withdraw approvals of such product;
- regulatory authorities may require additional warnings on the label;
- the Group may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
- health care professionals or patients may not accept the product and prefer competing alternatives;
- the Group could be sued and held liable for harm caused to patients;
- the regulators may require additional data from studies; and
- the Group’s reputation may suffer.Any of these events could prevent the Group from achieving or maintaining market acceptance of the particular product candidate, if approved, and could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.2.1.6.The success of the Group is dependent on its ability to obtain acceptable prices and reimbursements on its product candidatesIn most markets, drug prices and reimbursement levels are regulated or influenced by authorities, other healthcare providers, insurance companies or health maintenance organisations. Furthermore, the overall healthcare costs to society have increased considerably over the last decades and governments all over the world are striving to control them. There can be no guarantee that the Group’s final products, if any, will obtain the selling prices or reimbursement levels foreseen by the Group. If actual prices and reimbursement levels granted to the Group’s products prove lower than anticipated, it might have a negative impact on such products’ profitability and/or marketability, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.2.1.7.The Group relies, and will continue to rely, upon third-parties for clinical trials, product development and manufacturingThe Group cannot be certain that it will be able to enter into or maintain satisfactory agreements with third-party suppliers, like contract research organisations (“CROs”) for the conduct of clinical studies or manufacturers. The Group’s need to amend or change providers for the conduct of clinical studies might impact the timelines of the conduct of such studies. The Group’s failure to enter into agreements with such suppliers or manufacturers on reasonable terms, or at all, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
The Group needs to ensure that the manufacturing process complies with applicable regulations and manufacturing practices as well as the Company’s own high quality standards. Any product/product candidate, however, will require technically complex manufacturing processes or require a supply of specialised raw materials. As a result of these factors, the production of any product/product candidate may be disrupted from time to time. The Group may not be able to rapidly alter production volumes to respond to changes in future commercial sale or demand of a product candidate. Poor manufacturing performance of third party manufacturers, a disruption in the supply or the Group’s failure to accurately predict the demand for any future commercial sale of a product could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects. In addition, given that the Group’s products are intended to promote the health of patients, any supply disruption could lead to allegations that the public health has been endangered and could subject the Group to litigation.
2.1.8.The Group is subject to a number of manufacturing and supply chain risks, any of which could substantially increase its costs and limit and/or delay the supply of its product candidates
The process of manufacturing the Group’s product candidates is complex, highly regulated and subject to several risks, including but not limited to:
- The manufacturing of drug products is subject to product loss due to contamination, equipment failure, improper installation or operation of equipment or vendor or operator fault. Minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If contaminations are discovered in the Group’s product candidates or in the manufacturing facilities in which the products are made, these manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
- The manufacturing facilities in which the Group’s product candidates are made could be materially and adversely affected by equipment failures, labor shortages, natural disasters, power failures and several other factors.
- In order to supply investigational medicinal products for clinical trials, the Group and the Group’s contract manufactures need to comply with relevant EU and US good manufacturing practice (“GMP”) guidelines. The Group and the contract manufactures will be subject to inspections by relevant authorities in order to confirm compliance with relevant GMP guidelines and other applicable regulatory requirements. Any failure to follow GMP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture of the Group’s investigational medicinal products as a result of a failure in the facilities or operations to comply with regulatory requirements or pass any inspection could significantly impair the Group’s ability to develop and commercialise itscandidates, including leading to delays in availability, imposition of sanctions, warning letters, failure to grant market approvals, delays, suspension or withdrawal of approvals, license revocation, recalls of products, operation restrictions, criminal prosecutions and damage of reputation and its business.
- Any failure in producing or supplying starting materials, raw materials, container-closure system, pharmaceutical products used in combination with UV1 or similar products supplied by third parties to appropriate quality standards set from time to time by regulatory authorities could significantly impair the Group’s ability to develop and commercialise its candidates.Any adverse developments affecting manufacturing operations of the Group’s product candidates and/or damage that occurs during shipping may result in delays, inventory shortages, lot failures, withdrawals or recalls or other interruptions in the supply of the Group’s drug substance and drug product. The Group may also have to write-off inventory, incur other charges and expenses for supply of drug products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Inability to meet the demand of any of its product candidates, if approved, could damage the Group’s reputation and the reputation of its products among physicians, healthcare payers, patients or the medical community, which could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.9.The Group may not be able to enter into partnership agreements
The Group’s business strategy is to retain marketing rights and actively participate in the commercialisation of its lead product candidates either directly or through collaborative agreements with pharmaceutical or biotechnology companies. The Group cannot give any assurance that such agreements will be obtained on acceptable terms, nor that the Company will be able to enter into any such agreements at all. Furthermore, should such agreements be executed, there can be no assurance that the cooperation will work in practice and that agreements are adhered to or not terminated by the other party.
2.1.10.The Group faces an inherent business risk of liability claims in the event that the use or misuse of the compounds results in personal injury or death
The Group faces an inherent risk of product liability as a result of the clinical testing of its product candidates and will face an even greater risk if it commercialises any products. For example, the Group may be sued if its product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. If the Group cannot successfully defend itself against product liability claims, it may incur substantial liabilities or be required to limit commercialisation of its product candidates. Even a successful defense would require significant financial and management resources.
The Group has not experienced any clinical trial liability claims to date, but it may experience such claims in the future. The Group currently maintains clinical trial liability insurance for each trial in each country . The insurance policy may not be sufficient to cover claims that may be made against the Group. Clinical trial liability insurance may not be available in the future on acceptable terms, or at all. Any claims against the Group, regardless of their merit, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects because litigation related to these claims would strain the financial resources in addition to consuming the time and attention of the management.
2.1.11.The success, competitive position and future revenues will depend in part on the Group’s ability to protect its intellectual property and know-how
The Group’s commercial success will depend in part on its ability to obtain and maintain intellectual property protection with respect to its proprietary technology and products. This will require the Company to obtain and maintain patent protection for its products, methods, processes and other technologies, to preserve trade secrets, to prevent third parties from infringing on proprietary rights and to operate without infringing the proprietary rights of third parties. To date, the Group holds certain exclusive patent rights and has filed several patent applications, see Section 8.7. However, the Group cannot predict the degree and range of protection any patents will afford against competitors and competing technologies, including whether third parties will find ways to invalidate or otherwise circumvent the patents, if and when additional patents will be issued, whether or not others will obtain patents claiming aspects similar to those covered by the Group’s patents and patents applications, whether the Group will need to initiate litigation or administrative proceedings, or whether such litigation or proceedings are initiated by third parties against the Group which may be costly or whether third parties will claim that theGroup’s technology infringes upon their rights. The Group does not know whether any of the pending patent applications will result in the issuance of patents that effectively protect its technology or products. Should the Group not be able to protect its intellectual property and know-how, it could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.12.Patent applications filed by others could limit the Group’s freedom to operate
Competitors may claim that one or more of the Group’s product candidates infringe upon their patents or other intellectual property. Resolving a patent or other intellectual property infringement claim can be costly and time consuming and may require the Group to enter into royalty or license agreements. If this should be necessary, the Group cannot guarantee that it would be possible to obtain royalty or license agreements on commercially advantageous terms. A successful claim for patent or other intellectual property infringement could subject the Group to significant damages or an injunction preventing the manufacture, sale or use of the Group’s affected products or otherwise limit its freedom to operate. Any of these events could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.13.The Group may not be able to maintain sufficient insurance to cover all risks related to its operations
The Group’s business is subject to a number of risks and hazards, including, but not limited to industrial accidents, labour disputes and changes in the regulatory environment. Such occurrences could result in damage to properties, personal injury, monetary losses and possible legal liability. Although the Group seeks to maintain insurance or contractual coverage to protect against certain risks in such amounts as it considers reasonable, its insurance may not cover all the potential risks associated with the Group’s operations, which could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.14.The Group faces significant competition from other biotechnology and pharmaceutical companies
The biopharmaceutical industry is characterised by intense competition and rapid innovation. The Group’s competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Many major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions continue to invest time and resources in developing novel approaches to immuno-oncology. Promising results have spurred significant competition from major pharmaceutical and biotechnology companies alike. In the telomerase based cancer vaccine area specifically, the Group’s competitors include, among others, Asterias Biotherapeutics, Inc., Genovax S.r.l., Inovio Pharmaceuticals, Inc., Invectys SA and VAXON-Biotech.
Many of the Group’s competitors and potential competitors have substantially greater financial, technical and other resources than the Group does, such as larger research and development staff and experienced marketing and manufacturing organisations and well-established sales forces. Developments by others may render the product candidates or technologies obsolete or non-competitive. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in the Group’s competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. The Group’s competitors may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialised or less costly than the Group’s product candidates or may develop proprietary technologies or secure patent protection that the Group may need for the development of its technologies and products.
Even if the Group obtain regulatory approval of its product candidates, the availability and price of its competitors’ products could limit the demand and the price the Group is able to charge for its product candidates. The Group may not be able to implement its business plan if the acceptance of its product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to the Group’s product candidates, or if physicians switch to other new drug or biologic products or choose to reserve the Group’s product candidates for use in limited circumstances.
2.1.15.The Group may lose market exclusivity and face competition from low-cost generic products
The Group’s product candidates and/or related technology are or are expected to be protected by patent rights that are expected to provide the Group with exclusive marketing rights in various countries. However, patent rights are of varying strengths and durations. Loss of market exclusivity and the introduction of a generic version of the same or a similar medicine typically results in a significant and sharp reduction in net sales for the relevant product, given that generic manufacturers typically offer their versions of the same medicine at lower prices. The Group’s results may be affected by changes in public sentiment.
The pharmaceutical industry is under the close scrutiny of the public, governments and the media. In addition, there is significant pressure on the industry from certain nations to make the products available to their population at drastically lower costs. Any increase in such negative public sentiment or increase in public scrutiny or pressure from such nations could lead, among other things, to changes in legislation, to changes in the demand for the products, additional pricing pressures with respect to the products, or increased efforts to undercut intellectual property protections. Such changes could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.16.The Group relies, and will continue to rely, upon third-parties for development and commercialisation of its products
The Group cannot be certain that it will be able to enter into or maintain satisfactory agreements with third-party suppliers for the development and commercialisation of its products. Third-parties relied upon for development and commercialisation of its products include, but are not limited to:
Manufacturing and supply of UV1 is contracted to the Corden Pharma group. Failure to maintain satisfactory agreements with Corden Pharma or failure by Corden Pharma to timely manufacture and supply UV1 and provide documentation to appropriate standards set from time to time by regulatory authorities in relevant territories could significantly impair the Group’s ability to develop and commercialise UV1.
UV1 is developed with GM-CSF in the form of sargramostim as an adjuvant, and clinical study conduct and commercial use of UV1 is depending on availability of GM-CSF. GM-CSF is not developed, manufactured and distributed by the Group and cannot be fully controlled by the Group. Failure by third party to timely deliver GM-CSF product and documentation to appropriate standards set from time to time by regulatory authorities in relevant territories could significantly impair the Group’s ability to develop and commercialise UV1.
2.1.17.The Group may not be able to successfully implement its clinical, regulatory and commercial strategy
The Group’s strategy as described in Section 8.3 is to develop, manufacture and deliver innovative cancer vaccines to address unmet medical need and advance cancer care. Achieving the Group’s objectives involves inherent costs and uncertainties and there is no assurance that the Group will achieve its objectives or other anticipated benefits. Further, there is no assurance that the Group will be able to undertake its activities within their expected time frame, that the costs of any of the Group’s objectives will be at expected levels or that the benefits of its objectives will be achieved within the expected timeframe or at all.
The Group’s projections of the number of people who have the cancers it is targeting and who have the potential to benefit from treatment with the Group’s product candidates, are based on the Group’s beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for the Group’s product candidates may be limited or may not be amenable to treatment with the Group’s product candidates.
Further, the market for cancer products has to date shown itself to be relatively price insensitive to therapy costs. Healthcare budgets worldwide are however under severe stress. There is a risk that pricing of the kind experienced to date will become difficult to achieve. Once approval is obtained for a product, there is no certainty that the Group or its licencees will achieve commercial success since several factors will determine this including, clinical performance of the product, approved indication, competitive environment, pricing and reimbursement. There is no guarantee that after regulatory approval, reimbursement authorities will agree to cover the cost of the product. Delays in reimbursement or its denial will in turn delay or slow down adoption of the product in the market.
The Group’s ability to successfully implement its strategy could also be affected by factors beyond its control, such as the economic development in the markets in which it operates and the availability of acquisition and development opportunities in each market. Any failures, material delays or unexpected costs related to implementation of the Group’s strategy could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.18.The Group is highly dependent on its key personnel and the ability to attract new qualified personnel
The Group’s ability to compete in the highly competitive biotechnology and pharmaceutical industries and its ability to comply with complex EU and US guidelines related to its development work depend upon its ability to attract and retain highly qualified managerial, scientific and medical personnel. The loss of a key employee might impede the achievement of scientific development and commercial objectives. Competition for key personnel with the experience that is required is intense and is expected to continue to increase. There is no assurance that the Group will be able to retain key personnel, nor can assurances be given that the Group will be able to recruit new key personnel in the future. Any failure to attract or retain such personnel could result in the Group not being able to successfully implement its business plan and could impact the compliance of the Group’s quality system and thereby the compliance of the Group’s development work, which again could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.1.19.The Group may not be able to develop new product candidates
The Group’s future success will depend to a large extent upon the Group’s ability to develop its lead product candidate, UV1. The Group may not have the ability to invent, explore and develop product candidates that are of value to the medical market. Furthermore, the Group depends upon independent investigators and collaborators such as universities and medical institutions to do parts of the practical part of the chemical, pharmaceutical, analytical, preclinical and clinical research and development. These collaborators are not employees of the Group and the amount or timing of the resources they devote to the programmes cannot be fully controlled by the Group.
2.1.20.The Group’s business involves use of hazardous materials, chemicals and biological compounds and is thus exposed to environmental risks
The Group believes that its safety procedures for handling and disposing of such materials comply with applicable regulations, however, there will always be a risk of accidental contamination or injury. If liable for an accident or subject to an extended facility shutdown, the Group could incur significant costs, damages or penalties that could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
Risks related to regulations and litigation
2.2.1.The Group may be subject to litigation and disputes that could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects
The Group may in the future be involved from time to time in litigation and disputes. The operating hazards inherent in the Group’s business may expose the Group to, amongst other things, litigation, including personal injury litigation, intellectual property litigation, contractual litigation, environmental litigation, tax or securities litigation, as well as other litigation that arises in the ordinary course of business.
The Group is currently not involved in any litigation. However, it may in the future be involved in litigation matters from time to time. The Group cannot predict with certainty the outcome or effect of any claim or other litigation matter. The ultimate outcome of any litigation matter and the potential costs associated with prosecuting or defending such lawsuits, including the diversion of the Management’s attention to these matters, could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.2.2.The Group is exposed to risks related to regulatory processes and changes in regulatory environment
The Group’s operations could be affected by changes in intellectual property legal protections and remedies, trade regulations and procedures and actions affecting approval, production, pricing, reimbursement and marketing of products, as well as by unstable governments and legal systems and inter-governmental disputes. Any of these changes could have a material and adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.2.3.Even if the Group obtains regulatory approval for a product candidate, the Group’s products will remain subject to regulatory scrutiny
Any product candidate for whom the Group obtains marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labelling and promotional activities for such product, will be subject to continual and additional requirements of the different national and regional regulatory authorities. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. The different regulatory authorities closely regulate the post-approval marketing and promotion of pharmaceutical and biological products to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labelling.
In addition, late discovery of previously unknown problems with the Group’s products, manufacturing processes, or failure to comply with regulatory requirements, may lead to various adverse results, including, but not limited to, restrictions on such products, manufacturers or manufacturing processes, requirements to conduct post-marketing clinical trials, withdrawal of the products from the market, refusal to approve pending applications or supplements to approve applications that the Group submits and refusal to permit the import or export of the Group’s products.
The regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of the Group’s product candidates. If the Group is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if the Group is not able to maintain regulatory compliance, it may lose any marketing approval that it may have obtained, which could have a material adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.
2.2.4.The Group may experience a reduction in expected government grants (Skattefunn)
The Norwegian Tax Administration added a new section relating to Skattefunn in the latest publishing of Skatte-ABC (2018/2019) which states that ‘companies where half of the equity is lost as a consequence of accumulated losses’ is defined as a company in financial distress, and may no longer receive funding from Skattefunn. The Group is not as of 31 December 2018 defined as a company in financial distress under the definition in Skatte-ABC. However, an increase in accumulated losses in the future poses a risk for the Group of being defined as a company in financial distress under the definition, with the consequence that funding from Skattefunn will no longer be received. Funding that is received before companies are defined as financially distressed shall not be repaid.
Risks related to financing and market risk
2.3.1.The Group will require additional financing in the future in order to execute the Group’s strategy, which may not be available
The Group’s operations have consumed substantial amounts of cash since inception. The Group expects to continue to spend substantial amounts on the clinical development of its product candidates. The exact amounts needed are unknown. If the Group is able to gain regulatory approval for any of its product candidates, it will require significant additional amounts of cash in order to launch and commercialise any such product candidates. In addition, other unanticipated costs may arise. Because the design and outcome of the Group’s planned and anticipated clinical trials is highly uncertain, the Group cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialisation of its product candidates.
The Group’s future capital requirements depend on many factors, including but not limited to:
- the scope, progress, results and costs of researching and developing the Group’s product candidates and conducting preclinical studies and clinical trials;
- the size of the organisation needed to take product candidates through clinical trials and potentially commercialisation;
- the timing of, and the costs involved in, obtaining regulatory approvals for the Group’s product candidates if clinical trials are successful;
- the cost of commercialisation activities for the Group’s product candidates, if any of its product candidates are approved for sale, including marketing, sales and distribution costs;
- the cost of manufacturing the Group’s product candidates for clinical trials in preparation for regulatory approval and in preparation for commercialisation;
- the Group’s ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
- the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation;
- the timing, receipt and amount of sales of, or royalties on, the Group’s future products, if any; and
- the emergence of competing cancer therapies and other adverse market developments.
Adequate sources of funding may not be available when needed or may not be available on favourable terms. The Group’s ability to obtain such additional capital or financing will depend in part upon prevailing market conditions as well as conditions of its business and its operating results, and those factors may affect its efforts to arrange additional financing on satisfactory terms. If the Group raises additional funds by issuing additional shares or other equity or equity-linked securities, it will result in a dilution of the holdings of existing shareholders. If the Group raises additional capital through debt financing, the Group may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Group is unable to obtain adequate financing when needed, it may have to delay, reduce the scope of or suspend one or more of its clinical trials or research and development programs or its commercialisation efforts, which could have a material adverse effect on the Group’s business, financial condition and results of operations.
2.3.2.Present or future debt levels could limit the Group’s flexibility to obtain additional financing and pursue other business opportunities
The Group may incur additional indebtedness in the future. The current or future level of debt could have important consequences for the Group, including that:
- the Group’s ability to obtain additional financing for working capital, capital expenditures, acquisitions or other purposes may be impaired or such financing may be unavailable on favorable terms;
- the Group’s costs of borrowing could increase as it becomes more leveraged;
- the Group may need to use a substantial portion of its cash from operations to make principal and interest payments on its debt, reducing the funds that would otherwise be available for operations, future business opportunities and dividends to its shareholders;
- the Group’s debt level could make it more vulnerable than its competitors with less debt to competitive pressures, a downturn in its business or the economy generally; and
- the Group’s debt level may limit its flexibility in responding to changing business and economic conditions.The Group’s ability to service its current or future debt will depend upon, among other things, its future financial and operating performance, which will be affected by prevailing economic conditions as well as financial, business, regulatory and other factors, some of which are beyond its control. If the Group’s operating income is not sufficient to service its current or future indebtedness, the Group will be forced to take action such as reducing or delaying its business activities, acquisitions, investments or capital expenditures, selling assets, restructuring or refinancing its debt or seeking additional equity capital. The Group may not be able to affect any of these remedies on satisfactory terms, or at all, which could have a material adverse effect on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.2.3.3.Interest rate fluctuations could in the future materially and adversely affect the Group’s business, financial condition, results of operations, cash flows, time to market and prospectsThe Group may in the future be exposed to interest rate risk primarily in relation to any future interest bearing debt issued at floating interest rates and to variations in interest rates on bank deposits. Consequently, movements in interest rates could have material and adverse effects on the Group’s business, financial condition, results of operations, cash flows, time to market and prospects.2.3.4.Fluctuations in exchange rates could affect the Group’s cash flow and financial conditionThe Group has currency exposure to both transaction risk and translation risk related to its operating expenses. Transaction risk arises when future commercial transactions or recognised assets or liabilities are denominated in a currency that is not the Group’s functional currency. The Group undertakes various transactions in foreign currencies and is consequently exposed to fluctuations in exchange rates. The exposure arises largely from research expenses. The Group is mainly exposed to fluctuations in EUR, GBP and USD.Translation risk arises due to the conversion of amounts denominated in foreign currencies to NOK, the Group’s reporting and functional currency.
2.3.5.The Group may encounter financial reporting risk
As part of its responsibility to prevent and detect errors and fraud affecting its financial statements, the Group’s management has set up specific accounting and reporting procedures in relation to, amongst other things, revenue recognition process, taxation and other complex accounting issues. Any failure to prevent and detect errors and fraud within the implementation of such procedures may affect its reputation, business, financial results as well as its ability to meet its objectives.
Risks related to the Listing and the Shares
2.4.1.The price of the Shares could fluctuate significantly
The trading volume and price of the Shares could fluctuate significantly and the market price of the Shares may decline such that the Shares trade at prices significantly below the Offer Price. Securities markets in general have been volatile in the past. Some of the factors that could negatively affect the Share price or result in fluctuations in the price or trading volume of the Shares include, for example, changes in the Group’s actual or projected results of operations or those of its competitors, changes in earnings projections or failure to meet investors’ and analysts’ earnings expectations, investors’ evaluations of the success and effects of the strategy described in this Prospectus, as well as the evaluation of the related risks, changes in general economic conditions or the equities markets generally, changes in the industries in which the Group operates, changes in shareholders and other factors. This volatility has had a significant impact on the market price of securities issued by many companies. Those changes may occur without regard to the operating performance of these companies. The price of the Shares may therefore fluctuate based upon factors that have little or nothing to do with the Group, and these fluctuations may materially affect the price of the Shares.
2.4.2.There is no existing market for the Shares, and an active trading market may not develop
Prior to the Listing, there was no public market for the Shares, and there is no assurance that an active trading market for the Shares will develop, or be sustained. The market value of the Shares could be substantially affected by the extent to which a secondary market develops for the Shares following the completion of this Offering. Investors may not be in a position to sell their Shares quickly or at market price if there is no active trading in the Shares.
2.4.3.Future sales, or the possibility for future sales of substantial numbers of Shares could affect the Shares’ market price
The Company cannot predict what effect, if any, future sales of the Shares, or the availability of Shares for future sales, will have on the market price of the Shares. Sales of substantial amounts of the Shares in the public market following the Offering or the perception that such sales could occur, could adversely affect the market price of the Shares, making it more difficult for holders to sell their Shares or the Company to sell equity securities in the future at a time and price that they deem appropriate. Although the Company, its Board of Directors and the Management agree to be subject to restrictions, subject to certain exceptions, on their ability to sell or transfer their Shares for a period of 12 months after the Institutional Closing Date, with all shareholders owning more than 1.6% of the Shares in the Company, together with certain shareholders owning less than 1.6% of the Shares in the Company, agreeing to be subject to such restrictions for a period of 6 months after the Institutional Closing Date, the Managers may, in their sole discretion and at any time, waive such restrictions on sales or transfer during these periods. Additionally, following these periods respectively, all Shares owned by the Company, the aforementioned shareholders of the Company, the Board of Directors and the Management will be eligible for sale or other transfer in the public market, subject to applicable securities laws restrictions.
2.4.4.Future issuances of Shares or other securities could dilute the holdings of shareholders and could materially affect the price of the Shares
The Company may in the future decide to offer additional Shares or other securities in order to finance new capital-intensive projects, in connection with unanticipated liabilities or expenses or for any other purposes. Depending on the structure of any future offering, certain existing shareholders may not have the ability to purchase additional equity securities. An issuance of additional equity securities or securities with rights to convert into equity could reduce the market price of the Shares and would dilute the economic and voting rights of the existing shareholders if made without granting subscription rights to existing shareholders. Accordingly, the shareholders bear the risk of any future offerings reducing the market price of the Shares and/or diluting their shareholdings in the Company.
2.4.5.Pre-emptive rights to subscribe for Shares in additional issuances could be unavailable to U.S. or other shareholders
Under Norwegian law, unless otherwise resolved at the Company’s general meeting of shareholders (the “General Meeting”), existing shareholders have pre-emptive rights to participate on the basis of their existing ownership of Shares in the issuance of any new Shares for cash consideration. Shareholders in the United States, however, could be unable to exercise any such rights to subscribe for new Shares unless a registration statement under the U.S. Securities Act is in effect in respect of such rights and Shares or an exemption from the registration requirements under the U.S. Securities Act is available. Shareholders in other jurisdictions outside Norway could be similarly affected if the rights and the new Shares being offered have not been registered with, or approved by, the relevant authorities in such jurisdiction. The Company is under no obligation to file a registration statement under the U.S. Securities Act or seek similar approvals under the laws of any other jurisdiction outside Norway in respect of any such rights and Shares, and doing so in the future could be impracticaland costly. To the extent that the Company’s shareholders are not able to exercise their rights to subscribe for new Shares, their proportional interests in the Company will be diluted.
2.4.6.Investors could be unable to exercise their voting rights for Shares registered in a nominee account
Beneficial owners of the Shares that are registered in a nominee account (such as through brokers, dealers or other third parties) could be unable to vote such Shares unless their ownership is re-registered in their names with the VPS prior to any General Meeting. There is no assurance that beneficial owners of the Shares will receive the notice of any General Meeting in time to instruct their nominees to either effect a re-registration of their Shares or otherwise vote their Shares in the manner desired by such beneficial owners.
2.4.7.The Company’s ability to pay dividends in accordance with its dividend policy or otherwise is dependent on the availability of distributable reserves and the Company may be unable or unwilling to pay any dividends in the future
Norwegian law provides that any declaration of dividends must be adopted by the shareholders at the General Meeting, or by the Board of Directors in accordance with an authorisation from the General Meeting. Dividends may only be declared to the extent that the Company has distributable equity and that the Company’s equity and liquidity are sound in relation to the risk and scope of the Company’s business. As the Company’s ability to pay dividends is dependent on the availability of distributable reserves, it is, among other things, dependent upon receipt of dividends and other distributions of value from its subsidiaries and companies in which the Company may invest. As a general rule, the General Meeting may not declare higher dividends than the Board of Directors has proposed or approved. If, for any reason, the General Meeting does not declare dividends in accordance with the above, a shareholder will, as a general rule, have no claim in respect of such non- payment, and the Company will, as a general rule, have no obligation to pay any dividend in respect of the relevant period.
2.4.8.Investors could be unable to recover losses in civil proceedings in jurisdictions other than Norway
The Company is a public limited company organised under the laws of Norway. The majority of the members of the Board of Directors and Management reside in Norway. As a result, it may not be possible for investors to effect service of process in other jurisdictions upon such persons or the Company, to enforce against such persons or the Company judgments obtained in non-Norwegian courts, or to enforce judgments on such persons or the Company in other jurisdictions.
2.4.9.Norwegian law could limit shareholders’ ability to bring an action against the Company
The rights of holders of the Shares are governed by Norwegian law and by the Articles of Association. These rights may differ from the rights of shareholders in other jurisdictions. In particular, Norwegian law limits the circumstances under which shareholders of Norwegian companies may bring derivative actions. For example, under Norwegian law, any action brought by the Company in respect of wrongful acts committed against the Company will be prioritised over actions brought by shareholders claiming compensation in respect of such acts. In addition, it could be difficult to prevail in a claim against the Company under, or to enforce liabilities predicated upon, securities laws in other jurisdictions.
2.4.10.The Group will incur increased costs as a result of being a publicly traded company.
As a publicly traded company with its Shares listed on the Oslo Stock Exchange, the Group will be required to comply with the Oslo Stock Exchange’s reporting and disclosure requirements and with its corporate governance requirements. The Group will incur additional legal, accounting and other expenses to comply with these and other applicable rules and regulations, including potentially hiring additional personnel. The Group anticipates that its incremental general and administrative expenses as a publicly traded company will include, among other things, costs associated with annual and quarterly reports to shareholders, shareholders’ meetings, investor relations, incremental director and officer liability insurance costs and officer and director compensation. Any such increased costs, individually or in the aggregate, could have a material adverse effect on Ultimovacs’s business, results of operations, financial condition and prospects.
2.4.11.Exchange rate fluctuations could adversely affect the value of the Shares and any dividends paid on the Shares for an investor whose principal currency is not NOK
The Shares will be priced and traded in NOK on the Oslo Stock Exchange and any future payments of dividends on the Shares will be denominated in the currency of the bank account of the relevant shareholder, and will be paid to the shareholders through DNB Bank ASA, being the Company’s VPS registrar (the “VPS Registrar”). Shareholders registered in the VPS who have not supplied their VPS account operator with details of their bank account, will not receive payment of dividends unless they register their bank account details of their VPS account, and thereafter inform the VPS Registrar about said account. The exchange rate(s) that is applied when denominating any future payments of dividends to the relevant shareholder’s currency will be the VPS Registrar’s exchange rate on the payment date. Exchange rate movements of NOK will therefore affect the value of these dividends and distributions for investors whose principal currency is not NOK. Further, the market value of the Shares as expressed in foreign currencies will fluctuate in part as a result of foreign exchange fluctuations. This could affect the value of the Shares and of any dividends paid on the Shares for an investor whose principal currency is not NOK.
2.4.12.The transfer of shares is subject to restrictions under the securities laws of the United States and other jurisdictions
The Shares have not been registered under the U.S. Securities Act or any U.S. state securities laws or any other jurisdiction outside of Norway and are not expected to be registered in the future. As such, the Shares may not be offered or sold except pursuant to exemption from, or in transactions not subject to, the registration requirements of the U.S. Securities Act and other applicable securities laws. See section 17 “Selling and Transfer Restrictions”. In addition, there is no assurance that shareholders residing or domiciled in the United States will be able to participate in future capital increases or rights offerings.
