Mereo BioPharma Group plc Intends to Rely on SEC Relief and Delay Filing of its 2019
Annual Report on Form 20-F
On March 4, 2020, the U.S. Securities and Exchange Commission (the
SEC) issued an order under Section 36 (Release No. 34-88318) of the Securities Exchange Act of 1934, as amended (Exchange Act), granting exemptions from specified provisions
of the Exchange Act and certain rules thereunder. On March 25, 2020, the order was modified and superseded by a new SEC order (Release No. 34-88465), which provides conditional relief to public
companies that are unable to timely comply with their filing obligations as a result of the novel coronavirus (COVID-19) outbreak (the SEC Order). The SEC Order provides that a
registrant subject to the reporting requirements of Exchange Act Section 13(a) or 15(d), and any person required to make any filings with respect to such registrant, is exempt from any requirement to file or furnish materials with the
Commission under Exchange Act Sections 13(a), 13(f), 13(g), 14(a), 14(c), 14(f), 15(d) and Regulations 13A, Regulation 13D-G (except for those provisions mandating the filing of Schedule 13D or amendments to
Schedule 13D), 14A, 14C and 15D, and Exchange Act Rules 13f-1, and 14f-1, as applicable, if certain conditions are satisfied.
Mereo BioPharma Group plc (the Company) will be relying on the SEC Order to delay the filing of its Annual Report on Form 20-F for the year ended December 31, 2019 (the Report) due to circumstances related to COVID-19, which include disruptions to operations in terms of travel
and limited access to the Companys facilities resulting in an impact to staffs ability to carry out some of their usual work. Potential investors and business partners also face increased challenges to complete the processes necessary to
move ahead with an investment or partnership decision because of COVID-19s impact on the business of potential investors or partners and their ability to complete the diligence process in a COVID-19 environment alongside a broader dynamic of highly volatile equity markets which are also adversely affecting this process. Notwithstanding the foregoing, the Company plans to file the Report no later than
June 15, 2020 (which is 45 days from the Reports original filing deadline of April 30, 2020).
In light of the current COVID-19 pandemic, the Company will be including the following Risk Factor in its Report:
The COVID-19 pandemic or any other similar pandemic may materially impact our business including our ability to obtain further financial investment and planned clinical developments.
The outbreak of COVID-19 has developed into a global pandemic, spreading to most regions of the world including the
United States and the United Kingdom and to locations where we have facilities or ongoing clinical trials. The pandemic has resulted in impacts both direct and indirect to businesses including disruptions to resources, inability of workers to carry
out their jobs effectively, disruptions to supply chains, inability to travel and increased pressure on health systems required to treat COVID-19.
As a result of government and local regulation we have been required to introduce a work from home policy for the large majority of our work force and our
facilities remain open only for business critical activities. The requirement by governments to stay at home or to social distance limits normal communications and may also increase cyber security risk or create data accessibility
concerns. It also significantly curtails the numbers of individuals who can work in our offices.
COVID-19 has
created an unprecedented burden on health systems in impacted countries around the world. As a result, clinical centers have diverted resources away from the performance of clinical trials and because of that and the vulnerability of patients in the
Companys setrusumab clinical development program for osteogenesis imperfecta (OI) and its Phase 2 alvelestat program for patients with alpha-1 antitrypsin deficiency (AATD), the Companys clinical
activities will face some delays. AATD patients, in particular, are at greater risk from COVID-19 given that the condition is a respiratory and lung condition, for this reason, our Phase 2 alvelestat trial
will be delayed with topline data now expected in 2021. We are also currently planning to initiate a Phase 3 study in children with OI in late 2020, however, the initiation of the study may also be delayed.
As a result of the COVID-19 pandemic and depending on the length of such pandemic, we may experience disruptions that
would significantly impact our business including:
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A delay or interruption in our ability to enroll and treat patients and to obtain data from ongoing clinical
trials;
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A delay in our ability to further recruit patients to our clinical trials and to screen patients for eligibility
for our clinical trials;
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Interruption to key clinical trial activities including monitoring of clinical sites, patient visits, inability
to follow patients after they have received treatment and patient assessments;
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A delay in our ability to raise further finances to support our business as a result of the impact on investment
and stock prices more generally or as a result of a delay in clinical data availability;
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