Risk Management
Risk Area
Risks
Mitigating Actions
Risks relating to Risks related to clinical trials if results from When preparing a more extensive clinical trials Reponex Implement a
the business and the early clinical trials are not repeated in
meticulously designed clinical trial strategy that accounts for potential variations
in patient populations, ensuring robustness and reliability of results also in relation
to previously obtained data. Exhaustive literature search and key opinion leaders
industries in
more extensive clinical trials, if Reponex’
which Pharma
current and future clinical trials will not
Equity Group and prove a risk benefit ratio or sufficient clinical are the foundation for designing clinical trials which build on top of previous data
its subsidiary
company
benefit for Reponex Pharmaceuticals to be and to ensure more knowledge of safety and efficacy in relation to regulatory
able to subsequently sell its products to demands, which adds value to the products.
Reponex operate. partners or customers or obtain regulatory
approvals or if, clinical trial results may prove
inadequate to draw any conclusions and may Another important step is early engagement with regulatory authorities to foster
have to be repeated.
early and ongoing communication with regulatory bodies to align on trial
endpoints, methodologies, and expectations. This step also minimizes regulatory
surprises and ensures that trial designs align with the evolving regulatory
landscape.
Lastly, in some cases (if needed) comprehensive preclinical assessments will be
conducted to add additional knowledge of the data from early clinical trials to
ensure that the mode of action and proof of concept of products is even better
understood and causing the wanted output. This step adds more understanding of
project to minimize risk related to setup of more extensive clinical trials and add
additional value to the product.
Risks relating to Risks related to increased development costs Navigating the complexities of clinical trials is inherent in pharmaceutical
the business and as a consequence of either delays or
development, and the associated financial risks demand meticulous attention.
Evaluating the depth of financial planning underscores the company's proactive
stance in anticipating and addressing potential cost escalations. Risk factors such
as delays or unsatisfactory results, are integrated into the financial projections to
ensure the company are foresight and prepared for contingencies.
industries in
which Pharma
unsatisfactory results from clinical trials,
which may lead to increased cash burn for
Equity Group and Reponex and Pharma Equity Group
its subsidiary
company
compared to estimates.
Reponex operate
In the event of trial delays, it is important for Reponex to have an adaptive
financial strategy dealing with contingencies. Firstly, a planned budget for clinical
trial can include and financial overhead, creating a financial room for
contingencies. Secondly, the deal with the clinical sites/CRO can have a payment
structure based on the number of patients treated, which minimizes the cash burn
if any delays pauses the treatment of patients.
As the design of the upcoming clinical trials is a blinded placebo controlled data
won’t be available after all patients have been treated and data have been
interpreted. To minimize risks of unsatisfactory data, the development of the
protocol more specifically defining clinical outcome measures is very important,
which is done in collaboration with authorities and key opinion leaders. This gives
Reponex the best foundation for collecting data, which reflects the safety and
efficacy of the products. In case of unsatisfactory results Reponex have done
scenario planning, with clear defined operational tasks to understand the
unsatisfactory data and why it had happened together with a strategic plan for the
company to proceed on.
Risks relating to Repositioning Risks related to repositioning The risk for Reponex to never succeed in creating a marketable product is not
the business and of established clinically proven active
related to the repositioning strategy of the company. Reponex R&D and company
strategy revolves around recombining, rerouting and repurpose already existing
drugs and to proof they are efficacious and safe. The strategy minimizes early
industries in
pharmaceutical ingredients if Reponex
Pharmaceuticals never succeeds with any
which Pharma
Equity Group and particular product candidate and as a result, development steps, which shortens the need for time and finances compared to
its subsidiary
company
Reponex operate
never succeeds in creating a marketable
product
traditional drug development. Reponex Drug candidates will undergo clinical
testing as traditional developed drugs. This elucidate that the risk of never
succeeding in creating a marketable product is not related to the repositioning
strategy, but the related to the safety, efficacy and usability of the product like all
other development drugs in clinical testing.
Reponex out licensing strategy also entails that prior to a phase 3 clinical trial a
licensing partner have been identified to continue the clinical development of the
product. Depending on the structure of the licensing agreement, Reponex have
received payments and transferred the risked of getting market authorization to
the licensing partner.
24