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Mereo BioPharma Group plc (MREO)

NasdaqGS - NasdaqGS Delayed price. Currency in USD
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2.3700-0.0400 (-1.66%)
At close: 3:59PM EDT
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Previous close2.4100
Open2.4300
Bid2.3400 x 1100
Ask2.4200 x 1800
Day's range2.3150 - 2.4400
52-week range0.6900 - 4.2500
Volume41,954
Avg. volume232,035
Market cap155.753M
Beta (5Y monthly)1.03
PE ratio (TTM)N/A
EPS (TTM)N/A
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
  • Globe Newswire

    Mereo BioPharma Appoints Christine Fox as Chief Financial Officer and Heidi Petersen as Senior Vice President, Regulatory Affairs

    LONDON and REDWOOD CITY, Calif., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH) (“Mereo” or “the Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced the appointment of Christine Fox, CPA, as Chief Financial Officer (CFO) and Heidi Petersen as Senior Vice President, Regulatory Affairs. Ms. Fox brings an extensive array of financial experience to Mereo, including a background in financial operations and reporting, technical accounting and external audit. She replaces Interim CFO and current Mereo Board member Mr. Michael Wyzga, who will continue to serve on Mereo’s Board. Ms. Petersen brings more than 25 years of experience in the biopharmaceutical industry, with regulatory expertise across a range of therapeutic areas including immuno-oncology. Ms. Petersen’s appointment will be effective November 2, 2020 and Ms. Fox in January 2021. Denise Scots-Knight, Chief Executive Officer of Mereo, said: “Christine and Heidi are seasoned financial and regulatory executives and we are excited to welcome them to Mereo. The remainder of 2020 and 2021 will be an important period for Mereo as we expect multiple milestones across our pipeline, including the initiation of our Phase 1b/2 combination study with our anti-TIGIT antibody, etigilimab, in the coming weeks. With the addition of Christine and Heidi, we believe we have an exceptional senior management team in place as we continue to execute on our clinical development and business objectives in preparation for our next stage of growth.” Christine Fox, CPA, as Chief Financial OfficerMs. Fox is a Certified Public Accountant (CPA) with over 18 years of experience in financial operations and reporting, technical accounting and external audit. She has a proven track record of delivering high-quality financial information under international accounting standards and experience in the execution of corporate transactions. Prior to joining Mereo, Ms. Fox served as Group Financial Controller and Treasurer of Travelport where she managed a global financial operations team. Prior to joining Travelport, Ms. Fox served more than 10 years at KPMG in the U.S. and Switzerland, in positions of increasing responsibility, where she was primarily focused on large multi-national clients reporting under U.S. GAAP and IFRS across a wide variety of industries, including the pharmaceutical industry. Ms. Fox received a B.S. in accounting from Butler University. Heidi Petersen as Senior Vice President, Regulatory AffairsMs. Petersen is a seasoned regulatory affairs professional with 25 years of experience. Prior to joining Mereo, she served as Vice President, Regulatory Affairs at Kartos Therapeutics. Prior to Kartos, Ms. Petersen served as Vice President, Regulatory Affairs at Immune Design (acquired by Merck in 2019) where she provided global regulatory strategy on the development of the company’s immuno-oncology programs across all stages of clinical development. Previously, Ms. Petersen served as Vice President, Regulatory Affairs and Quality at BN-Immunotherapeutics (fully acquired by Bavarian Nordic in 2009) where she led global regulatory strategy for the company’s early and late-stage immuno-oncology programs. Earlier in her career, Ms. Petersen served as an independent regulatory consultant, and held business development and regulatory affairs positions with Pharmacyclics (subsequently acquired by AbbVie). She also held regulatory positions with Chiron Corporation (subsequently acquired by Novartis) and ALZA corporation (subsequently acquired by Johnson & Johnson). She received a master’s in public health from Columbia University and a B.S. in biology from Tulane University. About Mereo BioPharmaMereo 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. Additional Information The person responsible for arranging the release of this information on behalf of the Company is Charles Sermon, General Counsel. Forward-Looking StatementsThis 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 involve assumptions that could cause actual results to differ materially from the Company's historical experience and its present expectations or projections. These forward-looking statements are subject to risks and uncertainties, including, among other things, those described in the Company’s latest 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 investors 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 forward-looking statements, 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 7300Denise Scots-Knight, Chief Executive Officer   N+1 Singer (Nominated Adviser and Broker to Mereo)+44 (0)20 7496 3081Phil Davies Will Goode   Burns McClellan (US Investor Relations Adviser to Mereo)+01 212 213 0006Lisa Burns Steve Klass   FTI Consulting (UK Public Relations Adviser to Mereo) +44 (0)20 3727 1000Simon Conway Ciara Martin   Investorsinvestors@mereobiopharma.com

  • Globe Newswire

    Mereo BioPharma Announces FDA Clearance to Proceed into a Phase 1b/2 study for Etigilimab (Anti-TIGIT)

    On track to initiate Phase 1b/2 basket study of etigilimab in combination with an anti-PD-1 in a series of tumor types in Q4 2020 Plans to host virtual R&D day to review etigilimab development program and rare disease product pipeline in November 2020 LONDON and REDWOOD CITY, Calif., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH) (“Mereo” or “the Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced that the U.S. Food and Drug Administration has cleared an investigational new drug (IND) application to proceed with a Phase 1b/2 study for the Company’s lead oncology product candidate etigilimab. Etigilimab is a novel IgG1 monoclonal antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response. Mereo is on track to initiate the Phase 1b/2 basket study in the fourth quarter of 2020. The study will evaluate etigilimab in combination with an anti-PD-1 initially in approximately 100 patients with a defined series of tumor types, including biomarker enriched and rare tumor cohorts. The study will incorporate flat dosing (for patients 50 kg and higher) which is based on data from Mereo’s previous Phase 1a and Phase 1b combination studies with etigilimab.  Dr. John Lewicki, Chief Scientific Officer of Mereo, said: “Recent clinical data regarding anti-TIGIT therapies in combination with PDL-1/PD-1 inhibition have been promising. We designed etigilimab as a novel IgG1 which blocks TIGIT signalling while retaining an intact effector function and we believe our development approach is differentiated. We have selected the tumor types for our planned Phase 1b/2 basket combination study based on biomarker screening of large collections of different tumor samples and correlating these with suboptimal responses to anti- PDL-1/PD-1. We’ve also included tumor types where we saw evidence of activity in our previous Phase 1a/1b study. We look forward to initiating the study this quarter and providing additional details during our planned virtual R&D day.” In November 2020, Mereo plans to host a virtual R&D day featuring external experts to review the etigilimab development program, including the design and biomarker strategy of the Phase 1b/2 basket combination study. Mereo also plans to provide an overview of its rare disease product pipeline. Further information including the date/time of the virtual R&D day will be announced in the coming weeks. About EtigilimabEtigilimab is an antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains). TIGIT is a next generation checkpoint receptor shown to block T-cell activation and the body’s natural anti-cancer immune response. Etigilimab is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on immune cells with a goal of improving the activation and effectiveness of T-cell and NK cell anti-tumor activity. Mereo completed a Phase 1a dose escalation clinical trial with etigilimab in patients with advanced solid tumors and enrolled patients in a Phase 1b study in combination with nivolumab in selected tumor types. 23 patients were treated in the Phase 1a dose escalation study with doses up to 20 mg/kg Q2W. Tumor types included colorectal cancer, endometrial cancer, pancreatic cancer and other tumors. No dose limiting toxicities were observed. In the Phase 1b combination study, a total of ten patients, nine of whom had progressed on prior anti-PD-1/PD-L1 therapies were enrolled at doses of 3, 10, and 20 mg/kg. Eight patients were evaluable for tumor growth assessment, and all of these patients had progressed on PD-1/PD-L1 therapies with best responses including one patient with a partial response another with stable disease. These patients remained on study for up to 224 days. No dose limiting toxicities (DLTs) were observed and the most common related adverse events included fatigue, rash, and pruritis. Mereo plans to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a series of tumor types in Q4 2020. About Mereo BioPharmaMereo 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. Additional Information The person responsible for arranging the release of this information on behalf of the Company is Charles Sermon, General Counsel. Forward-Looking StatementsThis 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 involve assumptions that could cause actual results to differ materially from the Company's historical experience and its present expectations or projections. These forward-looking statements are subject to risks and uncertainties, including, among other things, those described in the Company’s latest 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 investors 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 forward-looking statements, 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 7300Denise Scots-Knight, Chief Executive Officer   N+1 Singer (Nominated Adviser and Broker to Mereo)+44 (0)20 7496 3081Phil Davies Will Goode   Burns McClellan (US Investor Relations Adviser to Mereo)+01 212 213 0006Lisa Burns Steve Klass   FTI Consulting (UK Public Relations Adviser to Mereo) +44 (0)20 3727 1000Simon Conway Ciara Martin   Investorsinvestors@mereobiopharma.com

  • Globe Newswire

    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 diseasePartnering discussions continue for portfolio of clinical-stage programs including setrusumab for osteogenesis imperfectaPIPE Financing of $70 million (£56 million) completed in June 2020, cash runway into 2022Conference Call Today at 8:00 a.m. EDT / 1:00 p.m. BSTLONDON and REDWOOD CITY, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- 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 portfolio.”Recent Highlights and Upcoming MilestonesEtigilimab (Anti-TIGIT) for Solid Tumors * On track to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020. Setrusumab for Osteogenesis Imperfecta (OI) * Receipt of FDA Rare Pediatric Disease Designation on September 23, 2020. * Following regulatory discussions in 1H 2020, both the FDA and EMA have agreed on the principles of a design of a single Phase 3 pediatric pivotal study in OI. * Intend to partner setrusumab prior to conducting a pivotal trial of setrusumab in children with severe OI. Partnering discussions are well underway with a range of potential structures including options for Mereo to retain commercial rights in certain regions. Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD) * Topline data from an ongoing Phase 2 proof of concept study remains on track for 2H 2021. * Announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease. * Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome (BOS). Partnering Discussions Continue for Portfolio of Other Clinical-Stage Programs * Leflutrozole for hypogonadotropic hypogonadism (HH)      º Partnering discussions continuing based on development in male infertility. * Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)      º Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA.Corporate * Appointment of Dr. Brian Schwartz and Dr. Jeremy Bender as Non-Executive Directors and departure of Mr Paul Blackburn as Non-Executive Director effective October 1, 2020 * Dr. John Lewicki appointed as Chief Scientific Officer and Dr. Ann Kapoun appointed as Head Translational R&D in July 2020.Financial Highlights * Cash resources of £56.8 million as at June 30, 2020 (June 30, 2019 £36.1 million). * £11.8 million raised in equity and debt in Q1 2020. * Additional $70 million (£56 million) raised in PIPE in Q2 2020. * Cash runway to early 2022. 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: 9572439A 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 the live call. About Mereo BioPharma Mereo 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.Additional Information 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)+1 212 213 0006 Lisa Burns  Steve Klass     FTI Consulting (UK Public Relations Adviser to Mereo) +44 (0)20 3727 1000 Simon Conway  Ciara Martin     Investorsinvestors@mereobiopharma.com Consolidated statement of comprehensive loss for the six months ended June 30, 2020 NotesSix 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 charge3(97,628)(998)(3,496) Loss on disposal of intangible assets4(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 OCI3 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 as at June 30, 2020 NotesJune 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 assets431,876 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 capital71,016 294 294  Share premium7161,785 121,684 121,684  Other capital reserves7127,727 58,004 59,147  Employee Benefit Trust shares7(1,305)(1,305)(1,305) Other reserves74,875 7,000 7,000  Accumulated losses7(270,681)(127,357)(146,065) Translation reserve7825 711 (499) Total equity 24,242 59,031 40,256  Non-current liabilities     Provisions81,698 1,927 1,449  Interest-bearing loans and borrowings614,506 11,721 5,373  Other liabilities 44 34 44  Warrant liability935,757 225 131  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  Provisions831 334 309  Interest-bearing loans and borrowings613,254 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