Full Press Release Details
Mereo BioPharma Announces Interim Financial Results for the Six Months Ended June 30, 2020 and Provides Corporate Update
On track to initiate Phase 1b/2 etigilimab (Anti-TIGIT) combination study in Q4 2020
Enrolment resumed in Phase 2 study of alvelestat in Alpha-1 Antitrypsin Deficiency and initiated placebo-controlled Phase 1b/2 clinical trial
in COVID-19 respiratory disease
Partnering discussions continue for portfolio of clinical-stage programs including setrusumab for
osteogenesis imperfecta
PIPE Financing of $70 million ( 56 million) completed in June 2020, cash runway into 2022
Conference Call Today at 8:00 a.m. EDT / 1:00 p.m. BST
London and Redwood City, Calif., September 29, 2020 - Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), Mereo or the Company ,
a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announces unaudited interim financial results for the six months ended June 30, 2020 and provides a corporate update.
Denise Scots-Knight, Chief Executive of Mereo, said: Following the closing of our $70 million financing in the first half of 2020 we have focussed on
executing our strategy, advancing etigilimab ( Anti-TIGIT ) for the treatment of solid tumors alongside developing our rare disease portfolio. We remain on track to initiate a Phase 1b/2 study of etigilimab (Anti-TIGIT) in combination with
an anti-PD-1 in a range of solid tumor types in Q4 2020. Our rare disease portfolio includes setrusumab for osteogenesis imperfecta which we plan to partner prior to the initiation of a pivotal Phase 3 study, and alvelestat which is being
investigated in an ongoing Phase 2 proof-of-concept study for alpha-1 anti-trypsin deficiency. We were also pleased to have recently announced the initiation of a Phase 1b/2 placebo-controlled study of alvelestat in COVID-19 infected patients
following the scientific publications demonstrating the involvement of neutrophil elastase in COVID-19 infection pathways. We also continue to advance other discussions with potential partners to optimize the value of our broader product
Recent Highlights and Upcoming Milestones
Etigilimab (Anti-TIGIT) for Solid Tumors
Setrusumab for Osteogenesis Imperfecta (OI)
Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD)
Partnering Discussions Continue for Portfolio of Other Clinical-Stage Programs
Financial Highlights
Conference Call Information
Mereo will host a live
conference call and webcast today at 8:00 a.m. EDT / 1:00 p.m. BST to discuss the Company s financial results and provide a corporate update.
Dial-in numbers: (866) 688-2942 (U.S.) or +1 (561) 569-9224 (U.K./International)
Conference ID number: 9572439
A live and archived webcast may
be accessed by visiting the Investors sections of the Company s website at https://www.mereobiopharma.com/investors/results-reports-and-presentations/. The archived webcast will remain available on the Company s website following
About Mereo BioPharma
BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for oncology and rare diseases. Mereo s lead oncology product candidate, etigilimab
( Anti-TIGIT ), has completed a Phase 1a dose escalation clinical trial in patients with advanced solid tumors and has been evaluated in a Phase 1b study in combination with nivolumab in select tumor types. Mereo s rare disease
product portfolio consists of setrusumab, which has completed a Phase 2b dose-ranging study in adults with osteogenesis imperfecta ( OI ), as well as alvelestat, which is being investigated in a Phase 2 proof-of-concept clinical trial in
patients with alpha-1 antitrypsin deficiency ( AATD ) and in a Phase 1b/2 clinical trial in COVID-19 respiratory disease.
The person responsible for arranging the release of this information on behalf of the Company is Charles Sermon, General Counsel.
Forward-Looking Statements
This Announcement contains forward-looking statements. All statements other than statements of historical fact contained in this Announcement are
forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements usually relate to
future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words believe, expect, anticipate,
plan, intend, foresee, should, would, could, may, estimate, outlook and similar expressions, including the negative thereof. The absence of
these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company s current expectations, beliefs and assumptions concerning future developments and business conditions
and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.
All of the Company s forward-looking statements involve known and unknown risks and uncertainties (some of which are significant or beyond its
control) and assumptions that could cause actual results to differ materially from the Company s historical experience and its present expectations or projections. The foregoing factors and the other risks and uncertainties that affect the
Company s business, including those described in its Annual Report on Form 20-F, Reports on Form 6-K and other documents filed from time to time by the Company with the United States Securities and Exchange Commission. The Company wishes to
caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of our forward-looking statements after the date they are made,
whether as a result of new information, future events or otherwise, except to the extent required by law.
Mereo BioPharma Contacts:
| Mereo | +44 (0)333 023 7300 | |
| Denise Scots-Knight, Chief Executive Officer | ||
| N+1 Singer (Nominated Adviser and Broker to Mereo) | +44 (0)20 7496 3081 | |
| Phil Davies | ||
| Will Goode | ||
| Burns McClellan (US Investor Relations Adviser to Mereo) | +01 212 213 0006 | |
| Lisa Burns | ||
| Steve Klass | ||
| FTI Consulting (UK Public Relations Adviser to Mereo) | +44 (0)20 3727 1000 | |
| Simon Conway | ||
| Ciara Martin | ||
| Investors | investors@mereobiopharma.com |
Consolidated statement of comprehensive loss
for the six months ended June 30, 2020
| Notes | Six months ended June 30, 2020 Unaudited 000 | Six months ended June 30, 2019 Unaudited 000 | Year ended December 31, 2019 Audited 000 | |||||||||||||
| Research and development expenses | (8,479 | ) | (11,918 | ) | (23,608 | ) | ||||||||||
| Administrative expenses | (8,212 | ) | (6,918 | ) | (15,909 | ) | ||||||||||
| Operating loss | (16,691 | ) | (18,836 | ) | (39,517 | ) | ||||||||||
| Net income recognised on acquisition of subsidiary | 1,035 | 1,035 | ||||||||||||||
| Finance income | 39 | 137 | 377 | |||||||||||||
| Finance charge | 3 | (97,628 | ) | (998 | ) | (3,496 | ) | |||||||||
| Loss on disposal of intangible assets | 4 | (11,302 | ) | |||||||||||||
| Net foreign exchange (loss)/gain | (519 | ) | (20 | ) | 483 | |||||||||||
| Loss before tax | (126,101 | ) | (18,682 | ) | (41,118 | ) | ||||||||||
| Taxation | 1,482 | 2,459 | 6,274 | |||||||||||||
| Loss for the period, attributable to equity holders of the parent | (124,619 | ) | (16,224 | ) | (34,844 | ) | ||||||||||
| Basic and diluted loss per share for the period | (1.05 | ) | (0.22 | ) | (0.39 | ) | ||||||||||
| Other comprehensive income / (loss) Items that may be subsequently reclassified to the income statement | ||||||||||||||||
| Fair value changes on investments held at fair value through OCI | 3 | 88 | ||||||||||||||
| Currency translation of foreign operations | 1,324 | 711 | (499 | ) | ||||||||||||
| Total comprehensive loss for the period, attributable to equity holders of the parent | (123,292 | ) | (15,425 | ) | (35,343 | ) |
Consolidated balance sheet
| Notes | June 30, 2020 Unaudited 000 | June 30, 2019 Unaudited 000 | December 31, 2019 Audited 000 | |||||||||||||
| Assets | ||||||||||||||||
| Non-current assets | ||||||||||||||||
| Property, plant and equipment | 11,225 | 13,100 | 11,558 | |||||||||||||
| Intangible assets | 4 | 31,876 | 45,157 | 44,456 | ||||||||||||
| 43,101 | 58,257 | 56,014 | ||||||||||||||
| Current assets | ||||||||||||||||
| Prepayments | 1,400 | 3,068 | 2,111 | |||||||||||||
| R&D tax credits | 6,624 | 7,745 | 10,426 | |||||||||||||
| Other taxes recoverable | 979 | |||||||||||||||
| Other receivables | 1,836 | 1,953 | 572 | |||||||||||||
| Short-term investments | 7,828 | |||||||||||||||
| Cash and short-term deposits | 56,821 | 28,290 | 16,347 | |||||||||||||
| 66,681 | 48,884 | 30,435 | ||||||||||||||
| Total assets | 109,782 | 107,141 | 86,449 | |||||||||||||
| Equity and liabilities | ||||||||||||||||
| Equity | ||||||||||||||||
| Issued capital | 7 | 1,016 | 294 | 294 | ||||||||||||
| Share premium | 7 | 161,785 | 121,684 | 121,684 | ||||||||||||
| Other capital reserves | 7 | 127,727 | 58,004 | 59,147 | ||||||||||||
| Employee Benefit Trust shares | 7 | (1,305 | ) | (1,305 | ) | (1,305 | ) | |||||||||
| Other reserves | 7 | 4,875 | 7,000 | 7,000 | ||||||||||||
| Accumulated losses | 7 | (270,681 | ) | (127,357 | ) | (146,065 | ) | |||||||||
| Translation reserve | 7 | 825 | 711 | (499 | ) | |||||||||||
| Total equity | 24,242 | 59,031 | 40,256 | |||||||||||||
| Non-current liabilities | ||||||||||||||||
| Provisions | 8 | 1,698 | 1,927 | 1,449 | ||||||||||||
| Interest-bearing loans and borrowings | 6 | 14,506 | 11,721 | 5,373 | ||||||||||||
| Other liabilities | 44 | 34 | 44 | |||||||||||||
| Warrant liability | 9 | 35,757 | 225 | 131 | ||||||||||||
| Lease liability | 11,167 | 13,139 | 9,318 | |||||||||||||
| 63,172 | 27,046 | 16,315 | ||||||||||||||
| Current liabilities | ||||||||||||||||
| Trade and other payables | 5,489 | 6,758 | 6,352 | |||||||||||||
| Accruals | 2,701 | 5,961 | 5,138 | |||||||||||||
| Provisions | 8 | 31 | 334 | 309 | ||||||||||||
| Interest-bearing loans and borrowings | 6 | 13,254 | 8,011 | 15,139 | ||||||||||||
| Contingent consideration liability | 354 | |||||||||||||||
| Lease liability | 893 | 2,586 | ||||||||||||||
| 22,298 | 21,064 | 29,878 | ||||||||||||||
| Total liabilities | 85,540 | 48,110 | 46,193 | |||||||||||||
| Total equity and liabilities | 109,782 | 107,141 | 86,449 |