Mereo BioPharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update
MREO 11.12.2024
Drug:UX143 setrusumab
Drug:MPH-966 alvelestat
Diseases:osteogenesis imperfecta
Diseases:AATD
About Gravity Analytica
Setrusumab receives Breakthrough Therapy designation from the FDA
Cash of
“The Phase 3 program for setrusumab, led by our partners at Ultragenyx, continues to progress according to plan and we look forward to reporting the topline data during 2025,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “The recent receipt of Breakthrough Therapy designation from the
Third Quarter 2024 Highlights, Recent Developments and Anticipated Milestones
Setrusumab (UX143)
- Our partner, Ultragenyx Pharmaceutical Inc., received Breakthrough Therapy Designation from the
U.S. Food and Drug Administration (FDA) for setrusumab (UX143) as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta (OI) Type I, III, or IV in patients 2 years of age and older.- The FDA’s decision was based on preliminary clinical evidence including the positive 14-month results from the Phase 2 portion of the Orbit study, which demonstrated a rapid and clinically meaningful decrease in fracture rate in patients, and from the completed Phase 2b ASTEROID study.
- Led by Ultragenyx, the Companies are actively advancing the Phase 3 Orbit and Cosmic studies of setrusumab in OI.
- The 14-month data from the Phase 2/3 Orbit study were presented by Ultragenyx in a late-breaking oral presentation at the
American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. - A further paper from SATURN (Systematic Accumulation of Treatment practices and Utilization, Real world evidence, and Natural history data for OI), has been published. This is part of the Company’s pre-launch activities designed to generate additional evidence to support coverage, pricing and reimbursement decisions across
Europe .
Alvelestat (MPH-966)
- Following the FDA feedback on the detailed Phase 3 package, including the study protocol and the initial validation work on SGRQ in AATD, the Company continues to expect that alvelestat will be Phase 3 ready around the end of 2024.
- The Company remains in discussions with several potential partners regarding the development and commercialization of alvelestat for AATD.
Third Quarter 2024 Financial Results
Total research and development (R&D) expenses decreased by
General and administrative (G&A) expenses increased by
Net loss for the third quarter of 2024 was
As of
Total ordinary shares issued as of September 30, 2024, were 773,672,299. Total ADS equivalents as of
About
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties. All statements other than statements of historical fact contained herein 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. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical development process; the Company’s reliance on third parties to conduct and provide funding for its clinical trials; the Company’s dependence on enrollment of patients in its clinical trials; and the Company’s dependence on its key executives. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of its Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the
| Mereo BioPharma Contacts: | ||
| Mereo | +44 (0)333 023 7300 | |
| Denise Scots-Knight, Chief Executive Officer | ||
| +01 646 930 4406 | ||
| Investors | investors@mereobiopharma.com | |
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 80,522 | $ | 57,421 | ||||
| Prepaid expenses and other current assets | 3,830 | 5,156 | ||||||
| Research and development incentives receivables | 2,371 | 1,183 | ||||||
| Total current assets | 86,723 | 63,760 | ||||||
| Property and equipment, net | 315 | 405 | ||||||
| Operating lease right-of-use assets, net | 909 | 1,245 | ||||||
| Intangible assets, net | 799 | 1,089 | ||||||
| Total assets | $ | 88,746 | $ | 66,499 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,748 | $ | 2,346 | ||||
| Accrued expenses | 3,529 | 5,467 | ||||||
| Convertible loan notes – current | 5,551 | — | ||||||
| Operating lease liabilities – current | 736 | 652 | ||||||
| Other current liabilities | 2,644 | 1,021 | ||||||
| Total current liabilities | 14,208 | 9,486 | ||||||
| Convertible loan notes – non-current | — | 4,394 | ||||||
| Warrant liabilities – non-current | 1,040 | 412 | ||||||
| Operating lease liabilities – non-current | 394 | 906 | ||||||
| Other non-current liabilities | 568 | 764 | ||||||
| Total liabilities | $ | 16,210 | $ | 15,962 | ||||
| Commitments and contingencies (Note 16) | ||||||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value £0.003 per share; 773,672,299 shares issued at | 3,051 | 2,775 | ||||||
| — | (1,230 | ) | ||||||
| Additional paid-in capital | 536,426 | 486,107 | ||||||
| Accumulated deficit | (455,837 | ) | (419,630 | ) | ||||
| Accumulated other comprehensive loss | (11,104 | ) | (17,485 | ) | ||||
| Total shareholders’ equity | 72,536 | 50,537 | ||||||
| Total liabilities and shareholders’ equity | $ | 88,746 | $ | 66,499 | ||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | 9,000 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | — | 235 | — | (2,847 | ) | |||||||||||
| Research and development | (3,170 | ) | (3,594 | ) | (12,109 | ) | (12,614 | ) | ||||||||
| General and administrative | (6,203 | ) | (5,708 | ) | (19,980 | ) | (14,827 | ) | ||||||||
| Loss from operations | (9,373 | ) | (9,067 | ) | (32,089 | ) | (21,288 | ) | ||||||||
| Other income/(expenses) | ||||||||||||||||
| Interest income | 983 | 689 | 2,160 | 1,368 | ||||||||||||
| Interest expense | (353 | ) | (700 | ) | (995 | ) | (2,528 | ) | ||||||||
| Changes in the fair value of warrants | (59 | ) | — | (576 | ) | 440 | ||||||||||
| Foreign currency transaction (loss)/gain, net | (6,425 | ) | 2,465 | (5,780 | ) | 455 | ||||||||||
| Other expenses, net | — | — | — | (6 | ) | |||||||||||
| Benefit from research and development tax credit | 226 | 82 | 1,073 | 1,202 | ||||||||||||
| Net loss before income tax | (15,001 | ) | (6,531 | ) | (36,207 | ) | (20,357 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net loss | $ | (15,001 | ) | $ | (6,531 | ) | $ | (36,207 | ) | $ | (20,357 | ) | ||||
| Loss per share – basic and diluted | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.05 | ) | $ | (0.03 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 770,146,589 | 684,974,190 | 727,808,860 | 645,997,203 | ||||||||||||
| Net loss | $ | (15,001 | ) | $ | (6,531 | ) | $ | (36,207 | ) | $ | (20,357 | ) | ||||
| Other comprehensive income/(loss) – Foreign currency translation adjustments, net of tax | 7,174 | (3,579 | ) | 6,381 | 99 | |||||||||||
| Total comprehensive loss | $ | (7,827 | ) | $ | (10,110 | ) | $ | (29,826 | ) | $ | (20,258 | ) | ||||
Source: Mereo BioPharma Group plc