Mereo BioPharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Mereo BioPharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Phase 3 Orbit and Cosmic studies of setrusumab in OI, conducted by our partner Ultragenyx, fully enrolled
我們的合作伙伴Ultragenyx進行的setrusumab在OI的第三階段Orbit和Cosmic研究已經招滿人。
New long-term Phase 2 data from the Phase 2/3 Orbit study demonstrated continued reduction in fracture rates
來自2/3軌道研究的新的長期2期數據顯示了骨折率持續下降。
Cash of $87.4 million as of June 30, 2024 expected to fund operations into 2027
截至2024年6月30日,8740萬美元的現金預計可支持運營至2027年。
London, August 13, 2024 - Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the second quarter ended June 30, 2024, and provided an update on recent corporate highlights. The Company reported cash and cash equivalents of $87.4 million as of June 30, 2024, which includes the net proceeds of the Company's $50 million registered direct offering in June 2024. Mereo expects that this will provide cash runway into 2027, through multiple key inflection points.
2024年8月13日,生物製藥公司Mereo BioPharma Group plc(NASDAQ:MREO)宣佈了截至2024年6月30日的第二季度財務結果,並提供了近期企業亮點的更新。 聲明中稱,截至2024年6月30日,公司的現金及現金等價物爲8740萬美元,其中包括公司於2024年6月的5000萬美元註冊直接發行的淨收益。Mereo預計,這將提供2027年的現金流,直至多個關鍵轉折點。
"We continued to make significant progress this quarter highlighted by additional positive data from the Phase 2 portion of the ongoing Phase 2/3 Orbit study in patients with OI," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "These data showed that the statistically significant annualized fracture rate reduction of 67% was maintained following treatment with setrusumab for at least 14 months of follow-up, further demonstrating the potential of setrusumab to generate long-term, clinically meaningful benefit for people living with OI. On alvelestat, we continue to work through the detailed regulatory submissions to ensure the AATD program is Phase 3-ready by the end of the year, in parallel with our ongoing discussions with multiple potential partners. With the proceeds from our June financing, we are well positioned through our key value inflection milestones and to support the ongoing pre-commercial activities essential for a successful launch of setrusumab in Europe following its potential approval."
Mereo的首席執行官Denise Scots-Knight博士表示:「本季度我們繼續取得重要進展,其中包括正在進行的OI患者的Phase 2/3 Orbit研究的第二階段的額外正向數據。」 「這些數據表明,在接受setrusumab治療至少14個月的隨訪後,統計學上顯著的年骨折率減少率爲67%。進一步證明setrusumab在爲OI患者帶來長期、臨床上有意義的效益方面的潛力。在alvelestat方面,我們繼續通過詳細的監管提交來確保AATD項目在年底前準備就緒,與此同時,我們正在與多個潛在合作伙伴進行商討。憑藉我們今年六月的融資收益,我們可以在關鍵的價值轉折里程碑以及在setrusumab在歐洲潛在獲批後支持必要的預商業活動方面擁有良好的位置。」
Second Quarter 2024 Highlights, Recent Developments and Anticipated Milestones
2024年第二季度亮點,最近發展和預期的里程碑
Setrusumab (UX143)
Setrusumab (UX143)
- The Phase 3 Orbit and Cosmic studies of setrusumab in OI, conducted by our partner Ultragenyx, were fully enrolled as of April 30, 2024.
- On June 11, 2024, Mereo, along with our partner Ultragenyx, announced positive 14-month results from the Phase 2 portion of the ongoing Phase 2/3 Orbit study (NCT05125809).
- The results from the Phase 2 portion of the Orbit study demonstrated that, as of the May 24, 2024 data cut-off date, treatment with setrusumab continued to significantly reduce incidence of fractures in patients with OI. Treatment with setrusumab also resulted in ongoing and meaningful improvements in lumbar spine bone mineral density (BMD) at month 12 without evidence of plateau.
- The median annualized rate of radiologically confirmed fractures across all 24 patients in the 2 years prior to treatment was 0.72. Following a mean treatment duration period of 16 months, the median annualized fracture rate was reduced by 67% to 0.00 (p=0.0014; n=24).
- The reduction in annualized fracture rates was associated with continued, clinically meaningful increases in BMD. At the 12-month time point, treatment with setrusumab resulted in a mean increase in lumbar spine BMD from baseline of 22% (p<0.0001, n=19) and an improvement of the lumbar spine BMD Z-score from a mean baseline of -1.73 to -0.49 at 12 months. The improvements in BMD and Z-scores were significant and consistent across all OI sub-types studied.
- As of the data cut-off date, there were no treatment-related serious adverse events observed in the study and no reported hypersensitivity reactions related to setrusumab.
- Research has been published from our osteogenesis imperfecta program: The 12-month results for the Phase 2b ASTEROID study in the Journal of Bone and Mineral Research and the first publication from SATURN (Systematic Accumulation of Treatment practices and Utilization, Real world evidence, and Natural history data for OI), which is expected to provide a coordinated data set across multiple treatment centers for OI across European countries, to support pricing and reimbursement decisions.
- More detailed data from the Phase 2 portion of the ongoing Phase 2/3 Orbit study will be presented at an upcoming scientific meeting
- 我們的合作伙伴Ultragenyx在2024年4月30日前完全招滿了OI研究setrusumab的第三輪Orbit和Cosmic研究。
- 在2024年6月11日,Mereo與我們的合作伙伴Ultragenyx宣佈,正在進行的Phase 2/3 Orbit研究(NCT05125809)持續14個月的積極結果。
- Orbit研究的第二階段結果顯示,截至2024年5月24日的數據截止日期,setrusumab繼續顯著減少OI患者的骨折發病率。接受setrusumab治療的患者在12個月內的腰椎骨密度(BMD)得到了持續和顯著的改善,沒有證據表明有平台現象。
- 在治療前2年內24名患者的放射學確認骨折年鑑化率的中位數爲0.72。經過平均治療時間爲16個月,中位數年化骨折率降低了67%至0.00(p = 0.0014;n = 24).
- 年化骨折率的減少與骨密度的繼續、臨床意義顯著的增加相關。在12個月時間點,接受setrusumab治療的患者腰椎BMD平均從基線上升了22%(p
- 在該研究中沒有觀察到與治療相關的嚴重不良事件,也沒有報告與setrusumab相關的超敏反應。
- 我們的骨發生不全項目發表了研究成果:連續12個月的ASTEROID(Phase 2)研究結果發表在《骨質疏鬆和礦物質研究雜誌》上,而來自SATURN(骨發生不全的系統性治療方法和實際運用、真實世界證據和自然歷史數據),這是預期提供歐洲多個治療中心的協調數據集,以支持定價和報銷決策的第一篇論文也已經發表。
- 來自正在進行的Phase 2/3 Orbit研究的更詳細數據將在即將到來的科學會議上展示。
Alvelestat (MPH-966)
Alvelestat (MPH-966)
- The Company continues to engage with multiple potential partners for the development and commercialization for alvelestat in AATD
- At the end of Q2, Mereo submitted the initial validation work for SGRQ in AATD and the detailed Phase 3 package including the study protocol to the FDA in order to maintain the potential to start the Phase 3 study around the end of 2024.
- 公司繼續與多個潛在合作伙伴接洽,開發和商業化AATD的alvelestat。
- 截至第二季度末,Mereo向FDA提交了針對AATD的SGRQ的初始驗證工作和包括研究方案的詳細的第三階段文件,以維持在2024年底左右啓動第三階段研究的潛力。
Second Quarter 2024 Financial Results
2024年第二季度財務結果
Total research and development (R&D) expenses increased by $1.2 million, or 33%, from $3.7 million in the second quarter of 2023 to $4.9 million in the second quarter of 2024. The increase was primarily due to increases of $1.9 million and $0.9 million of R&D expenses for alvelestat and setrusumab, respectively, partially offset by a $1.5 million reduction in R&D expenses for etigilimab. The increase in the program expenses for alvelestat primarily relates to preparatory work for the Phase 3 study, including manufacturing and drug formulation activities, SGRQ validation activities and regulatory filings and interactions. The increase in program expenses for setrusumab is driven by additional activities in Europe and resources for the input into development, regulatory and manufacturing plans with our partner, Ultragenyx, as the global development program is funded by Ultragenyx pursuant to our license and collaboration agreement. The reduction in etigilimab expenses was primarily due to the winding down and completion during 2023 of the open label Phase 1b/2 basket study in combination with an anti-PD-1 in a range of tumor types.
研發費用總額從2023年第二季度的370萬美元增加了120萬美元,或33%,至2024年第二季度的490萬美元。主要原因是用於alvelestat和setrusumab的研發費用增加了190萬美元和90萬美元,部分抵消了對etigilimab的研發費用的150萬美元的減少。alvelestat項目支出的增加主要涉及第三階段研究的準備工作,包括製造和藥物配製活動、SGRQ驗證活動和監管文件以及互動。 setrusumab項目的支出增加則是由於歐洲的額外活動以及與我們的合作伙伴Ultragenyx的開發、監管和製造計劃的輸入相關資源,因爲全球發展計劃由Ultragenyx根據我們的許可和合作協議資助。etigilimab的支出的減少主要是由於在與多種腫瘤類型結合抗PD-1的開放標籤Phase 1b / 2存儲器病筐研究在2023年結束期間的退出。
General and administrative (G&A) expenses increased by $5.2 million from $2.7 million in the second quarter of 2023 to $7.9 million in the second quarter of 2024. The increase is primarily related to: (i) a $3.4 million reduction in expenses recognized in the second quarter of 2023 for amounts from our depository to reimburse certain expenses incurred by us in respect of our ADR program, whereas in 2024, $1.7 million was received from our depository in the first quarter of 2024; and (ii) pre-commercial activities to lay the foundation for the commercial launch of setrusumab in Europe, including those to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe of $0.9 million.
2023年第二季度GIN的支出從270萬美元增加了520萬美元,至2024年第二季度的790萬美元。增長主要與:(i)2023年第二季度確認GIN存款以償還我們爲ADR計劃所負擔的某些費用的金額減少了340萬美元,而2024年從GIN存款中的170萬美元在2024年第一季度收到;以及(ii)爲奠定歐洲setrusumab商業上市基礎而進行的前期商業活動,包括支持HTA機構和支付者決策制定的90萬美元的準備。
Net loss for the second quarter of 2024 was $12.3 million, compared to $1.8 million during the second quarter of 2023, driven primarily by a one-time milestone payment of $9.0 million received in the second quarter of 2023, and increases in R&D expenses and G&A expenses in the second quarter of 2024.
2024年第二季度的淨虧損爲1230萬美元,而2023年第二季度的淨虧損爲180萬美元,主要由於2023年第二季度收到的900萬美元一次性里程碑款項,以及2024年第二季度研發和G&A費用的增加所致。
As of June 30, 2024, the Company had cash and cash equivalents of $87.4 million, compared to $57.4 million as of December 31, 2023. This includes net proceeds of the $50 million underwritten registered direct offering priced at-the-market on June 14, 2024. The Company expects, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses including pre-commercial activities for setrusumab, and capital expenditure requirements into 2027. This guidance does not include any potential upfront payments associated with a partnership for alvelestat or business development activity around any of the Company's non-core programs.
截至2024年6月30日,該公司的現金及現金等價物爲8740萬美元,而截至2023年12月31日爲5740萬美元。這包括2024年6月14日按市價定價的5000萬美元承銷註冊直接發行的淨收益。根據目前的運營計劃,該公司預期現有的現金及現金等價物餘額將使其能夠資助當前承諾的臨床試驗、營業費用(包括setrusumab的市前活動)和資本支出要求,直到2027年。本指導意見不包括與alvelestat或公司非核心業務的任何潛在前期付款有關的內容。
Total ordinary shares issued as of June 30, 2024, were 768,821,274. Total ADS equivalents as of June 30, 2024, were 153,764,254, with each ADS representing five ordinary shares of the Company.
截至2024年6月30日,公司發行的普通股總數爲768,821,274股。截至2024年6月30日,公司發行的ADS當量爲153,764,254,每個ADS代表公司的5股普通股。
About Mereo BioPharma
關於Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has two rare disease product candidates, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat primarily for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). The Company's partner, Ultragenyx Pharmaceutical, Inc., has completed enrollment in the Phase 3 portion of a pivotal Phase 2/3 pediatric study in young adults (5 to 25 years old) for setrusumab in OI and in the Phase 3 study in pediatric patients (2 to <7 years old) in the first half of 2024. The partnership with Ultragenyx includes potential additional milestone payments of up to $245 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Setrusumab has received orphan designation for osteogenesis imperfecta from the EMA and FDA, PRIME designation from the EMA and has pediatric disease designation from the FDA. Alvelestat has received U.S. Orphan Drug Designation for the treatment of AATD and Fast Track designation from the FDA. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which if successful could enable full approval in both the U.S. and Europe. In addition to the rare disease programs, Mereo has two oncology product candidates in clinical development. Etigilimab (anti-TIGIT) has completed a Phase 1b/2 basket study evaluating its safety and efficacy in combination with an anti-PD-1 in a range of tumor types including three rare tumors and three gynecological carcinomas – cervical, ovarian, and endometrial and is an ongoing Phase 1b/2 investigator led study at the MD Anderson Cancer Center in clear cell ovarian cancer; Navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has been partnered with Feng Biosciences Inc. in a global licensing agreement that includes milestone payments and royalties. Mereo has entered into an exclusive global license agreement with ReproNovo SA for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor. Under the terms of the agreement, ReproNovo, a reproductive medicine company, is responsible for all future development and commercialization of leflutrozole.
Mereo BioPharma是一家專注於稀有疾病創新治療的生物製藥公司。該公司有兩個稀有疾病產品,setrusumab用於治療骨發育不全(OI)和alvelestat主要用於治療嚴重的α-1抗胰蛋白ase缺陷相關性肺病(AATD-LD)。該公司的合作伙伴Ultragenyx Pharmaceutical, Inc.已完成了針對setrusumab在OI 2/3型臨床研究中5至25歲的年輕成人和臨床研究中2-7歲的小兒的3期關鍵性研究。與Ultragenyx的合作還包括潛在的額外里程碑付款高達24500萬美元,並在Ultragenyx領土的商業銷售上向Mereo支付版稅。Mereo保留了有關歐盟和英國商業權利,並將在這些領土的商業銷售上向Ultragenyx支付版稅。setrusumab已獲得EMA和FDA的骨發育不良孤兒疾病認定、EMA的PRIME認定以及FDA的小兒疾病認定。Alvelestat已獲得美國AATD治療孤兒藥物認定和FDA的快速軌道認定。ASTRAEUS和ATALANTa對AATD肺疾病的研究結果表明,該公司已與FDA和EMA就3期關鍵性研究的主要終點達成了一致,如果成功,將能夠獲得美國和歐洲的全面批准。除了稀有疾病項目外,Mereo還有兩個臨床開發中的腫瘤治療項目。Etigilimab(抗TIGIT)已完成了1b/2籃子研究,評價其與抗PD-1在治療包括3種罕見腫瘤和3種婦科癌症——宮頸癌、卵巢癌和子宮內膜癌的聯合使用的安全性和有效性,並在MD Anderson癌症中心進行1b/2調查者領導的清晰細胞卵巢癌臨床研究;Navicixizumab用於晚期卵巢癌的治療,已完成了1期研究,並與Feng Biosciences Inc.簽訂了全球許可協議,包括里程碑付款和版稅。Mereo已與ReproNovo SA簽訂了一項排他性全球許可協議,用於開發和商業化非甾體類芳香化酶抑制劑lefutrozole。根據協議條款,生殖醫學公司ReproNovo負責今後的所有lefutrozole的開發和商業化。
Forward-Looking Statements
前瞻性聲明
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.
本新聞稿包含「前瞻性聲明」,涉及重大風險和不確定性。除了本新聞稿所包含的歷史事實陳述之外,其他所有陳述都是指本新聞稿所涉及的未來事件、預期收入、收益、現金流或其他方面的運營或業務結果。「前瞻性聲明」通常與未來事件和預期收入、收益、現金流或其他方面的運營或業務結果有關。這些「前瞻性聲明」通常被認爲是「認爲」、「期望」、「預計」、「計劃」、「意圖」、「預見」、「應該」、「將」、「可能」、「估計」、「展望」和類似表達,包括其否定形式。然而,這些單詞的缺失並不意味着這些陳述不是「前瞻性」的。這些「前瞻性聲明」基於公司對未來業務發展和商業條件及其對公司潛在影響的當前期望、信念和假設。儘管管理層認爲這些「前瞻性聲明」是合理的和及時的,但是無法保證影響公司的未來發展的事件會是公司預計的事件。
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 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.
所有公司前瞻性聲明都涉及已知和未知風險和不確定性,其中一些風險和不確定性是重大或超出其控制範圍的,幷包含可能使公司的歷史經驗和目前的期望或投射結果有重大差異的假設。此類風險和不確定性包括但不限於臨床開發過程中固有的不確定性;公司依賴第三方進行其臨床試驗並提供資金;公司依賴其臨床試驗的患者註冊;以及公司依賴其關鍵執行官。您應仔細考慮上述因素以及影響公司業務的其他風險和不確定因素,包括其Form 10-k年度報告的「風險因素」部分以及在隨後提交給證券交易委員會的文件中討論的潛在風險等重要因素。公司希望告誡您不要過度依賴任何前瞻性聲明,這些聲明僅於此時此刻的日期有效。除法律規定外,公司無義務在其發佈的前瞻性聲明發表後公開更新或修訂任何聲明,無論是因爲新信息、未來事件還是其他原因。
Mereo BioPharma Contacts:
Mereo BioPharma聯繫方式:
Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Christine Fox, Chief Financial Officer
mereo +44 (0)333 023 7300
Denise Scots-Knight,首席執行官
首席財務官Christine Fox
MEREO BIOPHARMA GROUP PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(Unaudited)
mereo biopharma集團股份有限公司
簡明合併資產負債表
(以千爲單位,除每股數據外)
(未經審計)
June 30, |
December 31, |
|||||
2024 |
2023 |
|||||
Assets |
||||||
Current assets: |
||||||
Cash and cash equivalents |
$ |
87,431 |
$ |
57,421 |
||
Prepaid expenses and other current assets |
4,489 |
5,156 |
||||
Research and development incentives receivables |
2,020 |
1,183 |
||||
Total current assets |
93,940 |
63,760 |
||||
Property and equipment, net |
338 |
405 |
||||
Operating lease right-of-use assets, net |
985 |
1,245 |
||||
Intangible assets, net |
866 |
1,089 |
||||
Total assets |
$ |
96,129 |
$ |
66,499 |
||
Liabilities |
||||||
Current liabilities: |
||||||
Accounts payable |
$ |
2,700 |
$ |
2,346 |
||
Accrued expenses |
3,721 |
5,467 |
||||
Convertible loan notes – current |
4,931 |
— |
||||
Operating lease liabilities – current |
679 |
652 |
||||
Other current liabilities |
3,435 |
1,021 |
||||
Total current liabilities |
15,466 |
9,486 |
||||
Convertible loan notes – non-current |
— |
4,394 |
||||
Warrant liabilities – non-current |
925 |
412 |
||||
Operating lease liabilities – non-current |
552 |
906 |
||||
Other non-current liabilities |
536 |
764 |
||||
Total liabilities |
17,479 |
15,962 |
||||
Commitments and contingencies (Note 16) |
||||||
Shareholders' Equity |
||||||
Ordinary shares, par value £0.003 per share; 768,821,274 shares issued at June 30, 2024 (December 31, 2023: 701,217,089). |
3,032 |
2,775 |
||||
Treasury shares |
— |
(1,230) |
||||
Additional paid-in capital |
534,732 |
486,107 |
||||
Accumulated deficit |
(440,836) |
(419,630) |
||||
Accumulated other comprehensive loss |
(18,278) |
(17,485) |
||||
Total shareholders' equity |
78,650 |
50,537 |
||||
Total liabilities and shareholders' equity |
$ |
96,129 |
$ |
66,499 |
6月30日, |
12月31日 |
|||||
2024 |
2023 |
|||||
資產 |
||||||
流動資產: |
||||||
現金及現金等價物 |
$ |
87,431 |
$ |
57,421 |
||
資產預付款和其他流動資產的變動 |
4,489 |
5,156 |
||||
研發激勵應收款 |
2,020 |
1,183 |
||||
總流動資產 |
93,940 |
63,760 |
||||
資產和設備,淨值 |
338 |
405 |
||||
經營租賃使用權資產,淨值 |
985 |
1,245 |
||||
無形資產, 淨額 |
866 |
1,089 |
||||
總資產 |
$ |
96,129 |
$ |
66,499 |
||
負債 |
||||||
流動負債: |
||||||
應付賬款 |
$ |
5,487 |
$ |
2,346 |
||
應計費用 |
3721 |
5,467 |
||||
可轉換貸款票據 - 短期 |
4,931 |
— |
||||
流動經營租賃負債 |
679 |
652 |
||||
其他流動負債 |
3,435 |
1,021 |
||||
流動負債合計 |
15,466 |
9,486 |
||||
可轉換貸款票據 - 長期 |
— |
4,394 |
||||
認股權負債 - 長期 |
925 |
412 |
||||
非流動經營租賃負債 |
552 |
906 |
||||
其他非流動負債 |
536 |
764 |
||||
負債合計 |
17,479 |
15,962 |
||||
承諾和或可能存在的事項(注16) |
||||||
股東權益 |
||||||
普通股,每股面值£0.003;2024年6月30日發行了768,821,274股(2023年12月31日爲701,217,089股)。 |
3,032 |
2,775 |
||||
庫藏股 |
— |
(1,230) |
||||
額外實收資本 |
534,732 |
486,107 |
||||
累積赤字 |
(440,836) |
(419,630) |
||||
累計其他綜合損失 |
(18,278) |
(17,485) |
||||
股東權益合計 |
78,650 |
50,537 |
||||
負債和股東權益合計 |
$ |
96,129 |
$ |
66,499 |
MEREO BIOPHARMA GROUP PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
mereo biopharma集團股份有限公司
綜合損失及綜合損益簡明綜合表
(以千爲單位,除股份數量和每股金額外)
(未經審計)
Three Months Ended |
Six Months Ended |
||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||
Revenue |
$ |
— |
$ |
9,000 |
$ |
— |
$ |
9,000 |
|||
Operating expenses: |
|||||||||||
Cost of revenue |
— |
(3,430) |
— |
(3,083) |
|||||||
Research and development |
(4,946) |
(3,712) |
(8,939) |
(9,019) |
|||||||
General and administrative |
(7,868) |
(2,669) |
(13,777) |
(9,119) |
|||||||
Loss from operations |
(12,814) |
(811) |
(22,716) |
(12,221) |
|||||||
Other income/(expenses) |
|||||||||||
Interest income |
559 |
373 |
1,175 |
679 |
|||||||
Interest expense |
(331) |
(1,029) |
(641) |
(1,829) |
|||||||
Changes in the fair value of financial instruments |
(69) |
(102) |
(517) |
440 |
|||||||
Foreign currency transaction gain/(loss), net |
31 |
(803) |
644 |
(2,010) |
|||||||
Other expenses, net |
— |
— |
— |
(6) |
|||||||
Benefit from research and development tax credit |
369 |
621 |
847 |
1,120 |
|||||||
Net loss before income tax |
(12,255) |
(1,751) |
(21,208) |
(13,827) |
|||||||
Income tax benefit |
— |
— |
— |
— |
|||||||
Net loss |
$ |
(12,255) |
$ |
(1,751) |
$ |
(21,208) |
$ |
(13,827) |
|||
Loss per share – basic and diluted |
$ |
(0.02) |
$ |
(0.00) |
$ |
(0.03) |
$ |
(0.02) |
|||
Weighted average shares outstanding – basic and diluted |
711,770,804 |
628,421,064 |
706,407,371 |
626,185,695 |
|||||||
Net loss |
$ |
(12,255) |
$ |
(1,751) |
$ |
(21,208) |
$ |
(13,827) |
|||
Other comprehensive (loss)/income – Foreign currency translation adjustments, net of tax |
5 |
1,400 |
(793) |
3,678 |
|||||||
Total comprehensive loss |
$ |
(12,250) |
$ |
(351) |
$ |
(22,001) |
$ |
(10,149) |
三個月之內結束 |
銷售額最高的六個月 |
||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||
營業收入 |
$ |
— |
$ |
9000 |
$ |
— |
$ |
9000 |
|||
營業費用: |
|||||||||||
營業收入成本 |
— |
(3,430) |
— |
(3,083) |
|||||||
研發 |
(4,946) |
(3,712) |
(8,939) |
(9,019) |
|||||||
普通和管理 |
(7,868) |
(2,669) |
(13,777) |
(9,119) |
|||||||
經營虧損 |
(12,814) |
(811) |
(22,716) |
(12,221) |
|||||||
其他收入/(費用) |
|||||||||||
利息收入 |
559 |
373 |
1,175 |
679 |
|||||||
利息費用 |
(331) |
(1,029) |
(641) |
(1,829) |
|||||||
金融工具公允價值變動 |
(69) |
(102) |
(517) |
440 |
|||||||
外幣交易損益,淨額 |
31 |
(803) |
644 |
(2,010) |
|||||||
其他費用, 淨額 |
— |
— |
— |
(6) |
|||||||
研發稅收抵免收益 |
369 |
621 |
847 |
1,120 |
|||||||
稅前淨損失 |
(12,255) |
(1,751) |
(21,208) |
(13,827) |
|||||||
所得稅收益 |
— |
— |
— |
— |
|||||||
淨虧損 |
$ |
(12,255) |
$ |
(1,751) |
$ |
(21,208) |
$ |
(13,827) |
|||
每股虧損(普通股基本及攤薄) |
$ |
(0.02) |
$ |
(0.00) |
$ |
(0.03) |
$ |
(0.02) |
|||
基本和稀釋每股加權平均股數 |
711,770,804 |
628,421,064 |
706,407,371 |
626,185,695 |
|||||||
淨虧損 |
$ |
(12,255) |
$ |
(1,751) |
$ |
(21,208) |
$ |
(13,827) |
|||
其他綜合損益 - 外幣翻譯調整,淨額(稅後) |
5 |
1,400 |
(793) |
3,678 |
|||||||
總綜合虧損 |
$ |
(12,250) |
$ |
(351) |
$ |
(22,001) |
$ |
(10,149) |