Our second oncology product, navicixizumab for the treatment of late line ovarian cancer has
completed a Phase 1b study and was partnered in January 2020 for further development with OncXerna Inc. (OncXerna) on a global basis. In February 2022, we received a milestone payment of $2.0 million (£1.5 million) under the
license agreement with OncXerna. An associated payment was made to the former shareholders of Mereo BioPharma 5, Inc. under the Contingent Value Rights Agreement (CVR) of a total of $0.9 million (£0.7 million), after
deductions of costs, charges and expenditures. The milestone received and the associated CVR payment were recorded within Other income and expense.
We plan to partner or sell our other two product candidates, acumapimod for the treatment of acute exacerbation of chronic obstructive
pulmonary disease (AECOPD) and leflutrozole for the treatment of infertility and hypogonadotropic hypogonadism (HH) in obese men, recognizing the need for greater resources to take these product candidates to market.
In 2022, we conducted a comprehensive strategic review of our portfolio and capital allocation strategy. This review included a detailed
evaluation of current market conditions, the status of our ongoing programs, an analysis of emerging clinical data, our overall cost base and contractual commitments, consideration of obligations in our existing partnership agreements, and feedback
from potential new partners and shareholders. The resulting changes in our operating plan included a targeted reduction in the employee base of up to 40% and a significant reduction in other costs. Our operating plan maintains the ability to
progress our core programs, deliver on multiple near-term milestones and optimize value for shareholders. We retained the core capabilities and key personnel needed to advance our two core rare disease programs, setrusumab and alvelestat, and to
generate value from our assets. Our cash runway continues to be into 2026.
We do not have any approved product candidates and, as a
result, have not generated any revenue from product sales. Our ability to generate revenue sufficient to achieve profitability will depend on successful development and eventual commercialization of our product candidates either directly or with
partners, if approved. Since our inception, we have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical and manufacturing development
of our product candidates and seek regulatory approval. If approved, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.
We also expect to incur expenses in connection with the in-license or acquisition of additional rare
disease product candidates and the potential clinical development of any such product candidates.
Additionally, we will transition from
foreign private issuer to U.S. domestic filer status beginning in 2024 and expect to incur increased costs associated with being a U.S. domestic filer, including expenses related to more frequent financial reporting, preparation of financial
statements in accordance with US GAAP, compliance with U.S. federal proxy rules, and additional resources and services we will require in order to comply with Nasdaq and SEC rules and requirements applicable to U.S. domestic filers.
We are organized into a single operating segment following managements view of the business as a single portfolio of product candidates.
Research and development expenses are monitored at a product level; however, decisions over resource allocation are made at an overall portfolio level. Our financing is managed and monitored on a consolidated basis.
Recent Developments
On May 3, 2023,
the Company transferred the listing of its American Depositary Shares (ADSs) from the Nasdaq Global Market to the Nasdaq Capital Market. On May 8, 2023, the Company received notification from the Nasdaq Listings Qualifications
Department that the ADSs had, for the last 10 consecutive business days, a closing bid price at $1.00 per share or greater, and accordingly had regained compliance with Nasdaq Listing Rules.
In July 2023, we issued 1,929,040 ADSs representing 9,645,200 ordinary shares on conversion of convertible loan notes issued as part of a
private placement transaction in June 2020. The convertible loan notes matured on August 3, 2023, and on the maturity date we paid £2.6 million to settle the outstanding principal and accrued interest due to the maturity date. In July 2023 we
also issued 9,673,419 ADSs representing 48,367,095 ordinary shares for aggregate gross proceeds of $12.0 million (£9.3 million) through an
at-the-market offering pursuant to an Open Market Sale Agreement with Jefferies LLC which we entered into on August 5, 2021.
Significant Risks and Uncertainties
As a
biopharmaceutical company, the Company faces a number of risks and uncertainties. These are common for the industry and relate to operations, intellectual property, research and development, commercial and financial activities. For further
information about risks and uncertainties, which the Company faces, refer to the Annual Report. There have been no significant changes to the Companys overall risk profile since the publication of the Annual Report.