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Mereo BioPharma(MREO) - 2022 Q4 - Annual Report
2023-03-28 20:37
[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) [Company Overview and 2022 Progress](index=1&type=section&id=Company%20Overview%20and%202022%20Progress) Mereo BioPharma made significant 2022 progress in rare disease programs, with positive alvelestat Phase 2 data and funding secured into 2026 - In 2022, the company achieved significant progress in its core rare disease programs, particularly with encouraging Phase 2 ASTRAEUS study data for alvelestat in severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), and clear guidance from US and EU regulatory bodies on the design of a potential pivotal study[3](index=3&type=chunk) - The company's partner Ultragenyx completed Phase 2 patient enrollment for setrusumab (UX143) in the Phase 2/3 Orbit study for osteogenesis imperfecta (OI), with data expected in mid-2023[3](index=3&type=chunk) Cash and Short-Term Deposits at Year-End 2022 | Metric | Amount (Millions) | | :--- | :--- | | Cash and Short-Term Deposits (GBP) | £56.3 | | Cash and Short-Term Deposits (USD) | $68.2 | | Funding Runway | Into 2026 | [Alvelestat (MPH-966) Program Update](index=1&type=section&id=Alvelestat%20(MPH-966)%20Program%20Update) Alvelestat received FDA Fast Track, showed positive Phase 2 data, secured Phase 3 guidance, and is seeking partners - Alvelestat received US FDA Fast Track designation[6](index=6&type=chunk) - The Phase 2 ASTRAEUS study reported positive topline biomarker data, with post-hoc analysis showing an association between biomarker reduction and clinical outcomes[6](index=6&type=chunk) - FDA and EMA provided clear guidance that a single 12-18 month, approximately 200-patient, placebo-controlled Phase 3 study would be sufficient to support full marketing approval in the US and EU[6](index=6&type=chunk) - The company is exploring potential partners to fund further development of alvelestat in AATD-LD[6](index=6&type=chunk) [Setrusumab (UX143) Program Update](index=1&type=section&id=Setrusumab%20(UX143)%20Program%20Update) Ultragenyx completed setrusumab Phase 2 enrollment for OI, with data expected mid-2023, and a pediatric study starting H1 2023 - Mereo's partner Ultragenyx completed Phase 2 patient enrollment for setrusumab in the Phase 2/3 Orbit study for OI patients aged 5 to 25 years[6](index=6&type=chunk) - Phase 2 study data is expected to be announced in mid-2023[6](index=6&type=chunk) - A study for younger pediatric patients (comparing with bisphosphonates) is expected to be initiated by Ultragenyx in the first half of 2023[6](index=6&type=chunk) [Etigilimab (MPH-313) Program Update](index=2&type=section&id=Etigilimab%20(MPH-313)%20Program%20Update) Etigilimab's ACTIVATE trial completed Phase 1b, with additional data expected late 2023, and an ovarian cancer trial is ongoing - The Phase 1b/2 ACTIVATE trial completed its Phase 1b portion, enrolling a total of 76 patients[12](index=12&type=chunk) - The company expects to report additional data from the ACTIVATE study later in 2023[12](index=12&type=chunk) - A Phase 1b/2 trial of etigilimab in combination with nivolumab for platinum-resistant recurrent ovarian cancer is ongoing at The University of Texas MD Anderson Cancer Center, with plans to expand the study from 10 to 20 patients[12](index=12&type=chunk) [Navicixizumab (OMP305B83) Program Update](index=2&type=section&id=Navicixizumab%20(OMP305B83)%20Program%20Update) OncXerna plans a Phase 3 trial for navicixizumab in advanced ovarian cancer and is conducting a Phase 2 basket study - Mereo's partner OncXerna has stated its intention to initiate a Phase 3 trial for navicixizumab in advanced ovarian cancer[12](index=12&type=chunk) - OncXerna is conducting a Phase 2 basket study evaluating navicixizumab alone or in combination with chemotherapy for specific advanced solid tumors[12](index=12&type=chunk) [Full Year 2022 Financial Results](index=2&type=section&id=Full%20Year%202022%20Financial%20Results) [Research and Development Expenses](index=2&type=section&id=Research%20and%20Development%20Expenses) R&D expenses rose to **£25.0 million** in 2022, a **6% increase**, driven by etigilimab costs R&D Expenses Comparison (2021 vs 2022) | Metric | 2022 (£ Millions) | 2021 (£ Millions) | Change (£ Millions) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total R&D Expenses | 25.0 | 23.6 | 1.4 | 6% | | Etigilimab-related Expenses | Increase | Increase | 2.3 | - | | Alvelestat-related Expenses | Increase | Increase | 0.1 | 2% | | Setrusumab-related Expenses | Decrease | Decrease | 0.2 | 7% | - The increase in etigilimab R&D expenses was due to costs associated with additional patients and treatment duration in the open-label Phase 1b/2 basket study in 2022[8](index=8&type=chunk) - Setrusumab R&D expenses decreased as its global development is funded by partner Ultragenyx[8](index=8&type=chunk) [Administrative Expenses](index=2&type=section&id=Administrative%20Expenses) Administrative expenses increased to **£19.5 million** in 2022, a **23% rise**, due to Rubric Capital costs and share-based payments Administrative Expenses Comparison (2021 vs 2022) | Metric | 2022 (£ Millions) | 2021 (£ Millions) | Change (£ Millions) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Administrative Expenses | 19.5 | 15.9 | 3.6 | 23% | - The increase in administrative expenses was primarily driven by additional costs related to Rubric Capital's Schedule 13D filing and subsequent cooperation agreement, as well as increased share-based payment expenses[9](index=9&type=chunk) [Net Loss and Operating Performance](index=2&type=section&id=Net%20Loss%20and%20Operating%20Performance) The company reported a **£34.2 million** net loss in 2022, reversing a **£12.7 million** net profit from 2021 Net Profit/Loss Comparison (2021 vs 2022) | Metric | 2022 (£ Millions) | 2021 (£ Millions) | | :--- | :--- | :--- | | Net Loss/Profit Attributable to Equity Holders | (34.2) | 12.7 | | Operating Loss | (43.6) | - | | Gain from Fair Value Changes in Financial Instruments | 7.8 | - | [Cash Position and Financial Runway](index=2&type=section&id=Cash%20Position%20and%20Financial%20Runway) As of December 31, 2022, the company held **£56.3 million ($68.2 million)** in cash, with funds projected until 2026 Cash and Short-Term Deposits (As of December 31, 2022) | Metric | Amount (£ Millions) | Amount ($ Millions) | | :--- | :--- | :--- | | Cash and Short-Term Deposits | 56.3 | 68.2 | | Q4 2022 Net Cash Burn | 11.2 | 13.5 | | Funding Runway | Into 2026 | [Shares Outstanding](index=2&type=section&id=Shares%20Outstanding) As of December 31, 2022, the company had **625 million** ordinary shares and **119 million** ADSs outstanding Shares Outstanding (As of December 31, 2022) | Metric | Quantity (Millions) | | :--- | :--- | | Ordinary Shares | 625 | | ADSs | 119 | | ADS to Ordinary Share Ratio | 1 ADS = 5 Ordinary Shares | [About Mereo BioPharma](index=3&type=section&id=About%20Mereo%20BioPharma) Mereo BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative rare disease therapies - Mereo BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases[13](index=13&type=chunk) - The company has two rare disease product candidates: setrusumab (for osteogenesis imperfecta) and alvelestat (for severe alpha-1 antitrypsin deficiency-associated lung disease and bronchiolitis obliterans syndrome)[13](index=13&type=chunk) - The company's collaboration with Ultragenyx involves potential milestone payments of up to **$254 million** and royalties, with Mereo retaining commercial rights in the EU and UK; the global license agreement with OncXerna Therapeutics includes milestone payments of up to **$300 million** and royalties[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements about the company's pipeline, subject to risks and uncertainties - This press release contains forward-looking statements regarding the alvelestat Phase 3 study, setrusumab pediatric study, and the company's product pipeline[14](index=14&type=chunk) - Forward-looking statements are based on the company's current expectations, beliefs, and assumptions, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from historical experience or current predictions[14](index=14&type=chunk) - Investors are cautioned not to place undue reliance on any forward-looking statements, and the company undertakes no obligation to publicly update or revise any forward-looking statements after their release, except as required by law[14](index=14&type=chunk) [Contacts](index=4&type=section&id=Contacts) This section provides contact information for Mereo BioPharma and its investor relations advisor [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Comprehensive (Loss)/Income](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20(Loss)%2FIncome) In 2022, the company reported a **£34.196 million** net loss, reversing a **£12.725 million** net profit from 2021 Key Data from Consolidated Statements of Comprehensive (Loss)/Income | Metric | 2022 (£'000s) | 2021 (£'000s) | 2020 (£'000s) | | :--- | :--- | :--- | :--- | | Revenue | — | 36,464 | — | | Operating Loss | (43,569) | (20,936) | 37,569 | | Fair Value Changes in Financial Instruments | 7,805 | 40,039 | (109,849) | | Annual (Loss)/Profit Attributable to Equity Holders of the Parent | (34,196) | 12,725 | (163,628) | | Basic (Loss)/Profit Per Share (GBP) | (0.06) | 0.02 | (0.48) | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2022, total assets decreased to **£88.078 million**, with cash and short-term deposits at **£56.334 million** Key Data from Consolidated Balance Sheets (As of December 31) | Metric | 2022 (£'000s) | 2021 (£'000s) | | :--- | :--- | :--- | | Total Assets | 88,078 | 126,417 | | Cash and Short-Term Deposits | 56,334 | 94,296 | | Intangible Assets | 24,116 | 24,564 | | Total Liabilities | 26,210 | 38,415 | | Net Assets | 61,868 | 88,002 | | Accumulated Losses | (331,164) | (296,968) |
Mereo BioPharma(MREO) - 2021 Q4 - Annual Report
2022-03-31 20:19
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...
Mereo BioPharma (MREO) Investor Presentation - Slideshow
2021-09-26 16:29
| --- | --- | --- | --- | |---------------------------------------------------------------------|-------------------------------------------------------------------------|-------|-------| | | | | | | | | | | | | Unlocking the potential of novel targets for cancer and rare diseases | | | | M e r e o B i o P h a r m a G r o u p p l c N A S D A Q : M R E O | S e p t e m b e r 2 0 2 1 | | | Disclaimer This presentation has been prepared by Mereo BioPharma Group plc (the "Company") solely for your information an ...
Mereo BioPharma(MREO) - 2020 Q4 - Annual Report
2021-03-31 20:53
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . FORM 20-F (Mark One) ☐ SHELL COMPANY REPORT PURSUANT TO SECTI ...
Mereo BioPharma's (MREO) CEO Denise Scots-Knight on 2020 Interim Financial Results Conference Call (Transcript)
2020-09-29 14:11
Mereo BioPharma Group plc (NASDAQ:MREO) 2020 Interim Financial Results Conference Call September 29, 2020 8:00 AM ET Company Participants Steve Klass - IR, Burns McClellan Denise Scots-Knight - CEO Michael Wyzga - Interim CFO John Lewicki - Chief Scientific Officer Conference Call Participants Joseph Schwartz - SVB Leerink Operator Good morning ladies and gentlemen. Thank you for standing by and welcome to the Mereo BioPharma 2020 Interim Results Conference Call. At this time, all participants are in a list ...
Mereo BioPharma(MREO) - 2019 Q4 - Annual Report
2020-06-15 20:45
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Table of Contents Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...
Mereo BioPharma's (MREO) CEO Denise Scots-Knight on 2019 Interim Financial Results and Corporate Update Conference Call
2019-09-17 18:09
Mereo BioPharma Group plc 2019 Interim Financial Results Conference Call Summary Company Overview - **Company**: Mereo BioPharma Group plc (NASDAQ:MREO) - **Date of Call**: September 17, 2019 - **Participants**: - Richard Jones – Chief Financial Officer - Denise Scots-Knight – Chief Executive Officer Key Industry and Company Insights Core Strategy and Developments - Mereo BioPharma has made significant progress in the first half of 2019, focusing on rare diseases, particularly osteogenesis imperfecta (OI) and severe alpha-1 antitrypsin deficiency (AATD) [6][7] - The company has a diversified portfolio of therapeutic candidates, with significant investments from major pharmaceutical companies [7] - Completed two large Phase 2 studies in COPD and hypogonadotropic hypogonadism, both meeting primary endpoints [7] Lead Product Candidates - **Setrusumab**: A human monoclonal antibody targeting sclerostin, aimed at treating OI. It has shown a dual-action anabolic effect to build bone density [8][9] - OI is a rare genetic disorder with no FDA or EMA approved therapies [9] - Setrusumab has received prime designation from the EMA and orphan status from both EMA and FDA [9] - Interim data from the ASTEROID study showed a mean increase in trabecular volumetric bone mineral density (Tr vBMD) of 1.4% at three months and 3.2% at six months [10] - The study is the largest investigational clinical study in adult OI patients in the U.S. and EU [13] - **Alvelestat**: A small molecule inhibiting neutrophil elastase, currently in a Phase 2 proof-of-concept study for AATD [16][17] - AATD patients suffer from progressive lung deterioration, with the only approved therapy being plasma-derived protein, which is not widely available [18] - Top line data from the study is expected in mid-2020 due to slower than anticipated patient enrollment [18] Financial Highlights - R&D expenditure increased to £11.9 million in H1 2019 from £10.9 million in H1 2018 [25] - Administrative expenses decreased to £6.5 million from £7.1 million in the same period [26] - Total cash resources increased to £36.1 million following the merger with OncoMed Pharmaceuticals [27] Upcoming Milestones - Anticipated data readouts from lead programs in H2 2019 and into 2020 [6] - Completion of the ASTEROID study and initiation of a pivotal pediatric study for setrusumab [14][44] - Continued discussions for potential partnerships, particularly for leflutrozole and navicixizumab [42] Additional Important Insights - The company is focused on building relationships with key opinion leaders (KOLs) and patient representative organizations in both the EU and North America [19] - Regulatory interactions are ongoing, including discussions with the EMA regarding the use of HRpQCT as a biomarker [15] - The company aims to position itself as a leading integrated rare disease company, with a focus on significant value inflection points for its lead assets [8] This summary encapsulates the key points from the Mereo BioPharma conference call, highlighting the company's strategic focus, product development, financial performance, and future milestones.
Mereo BioPharma(MREO) - 2019 Q2 - Earnings Call Presentation
2019-09-17 13:49
| --- | --- | --- | --- | |-------|-------------------------|-------|-------| | | | | | | | | | | | | 2019 INTERIMS CORPORATE | | | DISCLAIMER THIS PRESENTATION AND ITS CONTENTS ARE CONFIDENTIAL AND ARE NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE SUCH DISTRIBUTION IS UNLAWFUL. This presentation has been prepared by Mereo BioPharma Group plc (the "Company") solely for your information and for use at a presentation for th ...
Mereo BioPharma(MREO) - 2018 Q4 - Annual Report
2019-04-29 20:59
OR Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Washington, D.C. 20549 For the fiscal year ended December 31, 2018 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...