TiumBio and Daewon Pharmaceutical Successfully Complete Phase 2 Clinical Trial of 'Merigolix (TU2670
Broader Therapeutic Potential: Positive Phase 2 results in both uterine fibroids and endometriosis could place Merigolix as a strong best-in-class candidate for novel drug approval and global licensing opportunities
Multi-Indication Development: Clinical trials are underway for three indications enhancing the asset value-uterine fibroids, endometriosis, and assisted reproductive technology (ART), the latter in collaboration with Hansoh Pharma in China
SEONGNAM, South Korea, May 7, 2025 /PRNewswire/ -- TiumBio (KRX: 321550.KQ), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable disease, today announced that Merigolix (code name: TU2670, Daewon's code name: DW4902) has successfully met the primary endpoint of reducing heavy menstrual bleeding in a Phase 2 clinical trial for uterine fibroids. In this trial, Merigolix demonstrated statistically significant improvements across all dosage groups compared to placebo in patients with uterine fibroids.
Merigolix is an investigational, once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist. Unlike traditional GnRH agonists, which require injection and often lead to an initial hormone surge, Merigolix offers a more patient-friendly oral administration without an initial hormonal flare, providing a faster onset of action and improved treatment adherence.
The Phase 2 clinical trial of Merigolix in uterine fibroids was conducted by TiumBio's partner, Daewon Pharmaceutical, and enrolled a total of 71 women diagnosed with uterine fibroids. Participants were randomly assigned to receive high, medium, or low doses of Merigolix, or placebo, administered orally once daily for 12 weeks, followed by a 12-week observation period. The results showed that Merigolix led to statistically significant improvements in heavy menstrual bleeding (HMB)—a validated clinical endpoint—across all dosage groups compared to the placebo.
In addition to the primary endpoint, Merigolix demonstrated statistically and clinically meaningful improvements in several key secondary endpoints, including fibroid size reduction, increased hemoglobin levels (indicating improved anemia), and relief of pelvic pain. The safety and tolerability profile of Merigolix was consistent with prior clinical data, with no new safety signs.
The mechanism of action of Merigolix can be used in various disorders, including endometriosis, uterine fibroids, ART, precocious puberty, and prostate cancer. Notably, in a separate Phase 2 clinical trial for endometriosis completed in 2024, Merigolix also showed excellent therapeutic efficacy and safety, further reinforcing its potential as a promising new treatment.
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Cash and cash equivalents, restricted cash and bank deposits As of June 30, 2025, the Company had cash and cash equivalents, restricted cash, restricted cash in other non-current assets, and short-term and long-term bank deposits of RMB2,311.2 million (US$322.6 million), compared with RMB4,467.8 million as of December 31, 2024. The decrease was primarily due to a special cash dividend distribution of US$300 million in February 2025. [1] "Adjusted net income (non-GAAP)" is defined as net income excluding share of income (loss) in equity method investments, impairment losses and fair value adjustments on investments, and impairment losses of goodwill and intangible assets. For more information, please refer to "Use of Non-GAAP Financial Measures" and "Reconciliations of GAAP and Non-GAAP Results" at the end of this press release. [2] "MAUs" refers to the number of active mobile users (exclusive of innovative business unless the context otherwise indicates) in a given period. Average mobile MAUs for a given period is calculated by dividing (i) the sum of active mobile users for each month of such period, by (ii) the number of months in such period. [3] "Quarterly average paying users" refers to the average paying users for each quarter during a given period of time calculated by dividing (i) the sum of paying users for each quarter of such period, by (ii) the number of quarters in such period. "Paying user" refers to a registered user that has purchased virtual gifts on our platform at least once during the relevant period. [4] "Monthly average paying users" refers to the monthly average number of paying users during a given period of time calculated by dividing (i) the sum of paying users in each month of such period, by (ii) the number of months in such period. "Paying user" refers to a registered user that has purchased virtual gifts on our platform at least once during the relevant period. [5] Each ADS represents one ordinary share for the relevant period and calendar year. About DouYu International Holdings Limited Headquartered in Wuhan, China, DouYu International Holdings Limited (Nasdaq: DOYU) is a leading game-centric live streaming platform in China and a pioneer in the eSports value chain. DouYu operates its platform on both PC and mobile apps to bring users access to immersive and interactive games and entertainment livestreaming, a wide array of video and graphic content, as well as opportunities to participate in community events and discussions. By nurturing a sustainable technology-based talent development system and relentlessly producing high-quality content, DouYu consistently delivers premium content through the integration of livestreaming, video, graphics, and virtual communities with a primary focus on games. This enables DouYu to continuously enhance its user experience and pursue long-term healthy development. For more information, please see Use of Non-GAAP Financial Measures Adjusted (loss) income from operations is calculated as (loss) income from operations adjusted for Impairment of goodwill and intangible assets. Adjusted net (loss) income is calculated as net (loss) income adjusted for share of income (loss) in equity method investments, impairment losses and fair value adjustments on investments and impairment losses of goodwill and intangible assets. Adjusted net (loss) income attributable to DouYu is calculated as net (loss) income attributable to DouYu adjusted for share of income (loss) in equity method investments, impairment losses and fair value adjustments on investments, and impairment losses of goodwill and intangible assets. 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As non-GAAP financial measures have material limitations as analytical metrics and may not be calculated in the same manner by all companies, they may not be comparable to other similarly titled measures used by other companies. In light of the foregoing limitations, you should not consider non-GAAP financial measures as a substitute for, or superior to, such metrics in accordance with U.S. GAAP. For more information on these non-GAAP financial measures, please see the table captioned "Reconciliations of GAAP and Non-GAAP Results" near the end of this release. Exchange Rate Information This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of RMB7.1636 to US$1.00, the noon buying rate in effect on June 30, 2025, in the H.10 statistical release of the Federal Reserve Board. The Company makes no representation that the RMB amounts could have been, or could be, converted, realized, or settled in U.S. dollars, at that rate on June 30, 2025, or at any other rate. Safe Harbor Statement This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward- looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company's results of operations and financial condition; the Company's business strategies and plans; general market conditions, in particular, the game live streaming market; the ability of the Company to retain and grow active and paying users; changes in general economic and business conditions in China; any adverse changes in laws, regulations, rules, policies or guidelines applicable to the Company; and assumptions underlying or related to any of the foregoing. In some cases, forward-looking statements can be identified by words or phrases such as "may," "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law. Investor Relations Contact In China: Chenyang Yan DouYu International Holdings Limited Email: ir@ Tel: +86 (10) 6508-0677 Andrea Guo Piacente Financial Communications Email: douyu@ Tel: +86 (10) 6508-0677 In the United States: Brandi Piacente Piacente Financial Communications Email: douyu@ Tel: +1-212-481-2050 UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (All amounts in thousands, except share, ADS, per share and per ADS data)As of December 31As of June 30202420252025 ASSETS RMB RMBUS$ (1) Current assets:Cash and cash equivalents 1,017,1481,535,924214,407 Restricted cash 8317024 Short-term bank deposits 3,070,374583,72381,485 Accounts receivable, net 49,05755,4887,746 Prepayments 26,88524,7683,457 Amounts due from related parties 74,17565,1819,099 Other current assets, net 231,354234,95732,799 Total current assets 4,469,0762,500,211349,017 Non-current assets:Property and equipment, net 7,0935,635787 Intangible assets, net 60,91745,1946,309 Long-term bank deposits 360,000160,00022,335 Investments 456,815409,88557,218 Right-of-use assets, net 15,81613,0641,824 Other non-current assets 76,61676,06810,619 Total non-current assets 977,257709,84699,092 TOTAL ASSETS 5,446,3333,210,057448,109 LIABILITIES AND SHAREHOLDERS' EQUITY LIABILITIESCurrent liabilities:Accounts payable 498,667482,74667,389 Advances from customers 4,4443,293460 Deferred revenue 252,346244,02934,065 Accrued expenses and other current liabilities 242,517228,07731,837 Amounts due to related parties 222,589234,52932,739 Lease liabilities due within one year 11,45812,1321,694 Total current liabilities 1,232,0211,204,806168,184 Non-current liability:Lease liabilities 4,22322031 Total non-current liability 4,22322031 TOTAL LIABILITIES 1,236,2441,205,026168,215 (1) Translations of certain RMB amounts into U.S. dollars at a specified rate are solely for the convenience of the reader. Unless otherwise noted,all translations from RMB to U.S. dollars are made at a rate of RMB7.1636 to US$1.00, the noon buying rate in effect on June 30, 2025, in theH.10 statistical release of the Federal Reserve Board. UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (CONTINUED) (All amounts in thousands, except share, ADS, per share and per ADS data)As of December 31As of June 30202420252025RMB RMB US$ (1) SHAREHOLDERS' EQUITYOrdinary shares 20203 Additional paid-in capital 7,514,4985,363,717748,746 Accumulated deficit (3,791,817)(3,833,600)(535,149) Accumulated other comprehensive income 487,388474,89466,294 Total DouYu Shareholders' Equity 4,210,0892,005,031279,894 Total Shareholders' Equity 4,210,0892,005,031279,894 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 5,446,3333,210,057448,109(1) Translations of certain RMB amounts into U.S. dollars at a specified rate are solely for the convenience of the reader. Unless otherwise noted,all translations from RMB to U.S. dollars are made at a rate of RMB7.1636 to US$1.00, the noon buying rate in effect on June 30, 2025, in theH.10 statistical release of the Federal Reserve Board. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) (All amounts in thousands, except share, ADS, per share and per ADS data) Three Months EndedSix Months EndedJune 30, 2024March 31, 2025June 30, 2025June 30, 2025June 30, 2024June 30, 2025June 30, 2025RMBRMBRMBUS$ (1)RMBRMBUS$ (1) Net revenues 1,032,041947,0511,053,915147,1212,071,7252,000,966279,324 Cost of revenues (947,823)(833,543)(911,975)(127,307)(1,878,501)(1,745,518)(243,665) Gross profit 84,218113,508141,94019,814193,224255,44835,659 Operating (expense) income Sales and marketing expenses (76,963)(72,929)(61,585)(8,597)(152,533)(134,514)(18,777) General and administrative expenses (48,496)(35,787)(39,816)(5,558)(91,293)(75,603)(10,554) Research and development expenses (50,135)(32,749)(27,611)(3,854)(104,285)(60,360)(8,426) Other operating (expense) income, net (28,189)1,8151,318184(131,617)3,133437 Total operating expenses (203,783)(139,650)(127,694)(17,825)(479,728)(267,344)(37,320) (Loss) income from operations (119,565)(26,142)14,2461,989(286,504)(11,896)(1,661) Other (expenses) income, net (943)(58,554)9,4631,321(943)(49,091)(6,853) Interest income 75,97210,14119,2002,680157,06629,3414,096 Foreign exchange income (loss) 604258(17)(2)75724134 (Loss) income before income taxes and share of loss in equity method investments (43,932)(74,297)42,8925,988(129,624)(31,405)(4,384) Income tax expense (2,510)(5,134)(8,151)(1,138)(2,510)(13,285)(1,855) Share of (loss) income in equity method investments (2,727)(181)3,088431(4,988)2,907406 Net (loss) income (49,169)(79,612)37,8295,281(137,122)(41,783)(5,833) Net (loss) income attributable to ordinary shareholders of the Company (49,169)(79,612)37,8295,281(137,122)(41,783)(5,833) Net (loss) income per ordinary shareBasic (1.58)(2.64)1.250.17(4.36)(1.38)(0.19) Diluted (1.58)(2.64)1.250.17(4.36)(1.38)(0.19) Net (loss) income per ADS(2)Basic (1.58)(2.64)1.250.17(4.36)(1.38)(0.19) Diluted (1.58)(2.64)1.250.17(4.36)(1.38)(0.19) Weighted average number of ordinary shares used in calculating net (loss) income per ordinary share Basic 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Diluted 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Weighted average number of ADS used in calculating net (loss) income per ADS(2) Basic 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Diluted 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859(1) Translations of certain RMB amounts into U.S. dollars at a specified rate are solely for the convenience of the reader. Unless otherwise noted, all translationsfrom RMB to U.S. dollars are made at a rate of RMB7.1636 to US$1.00, the noon buying rate in effect on June 30, 2025, in the H.10 statistical release of theFederal Reserve Board. (2) Each ADS represents one ordinary share. RECONCILIATIONS OF GAAP AND NON-GAAP RESULTS (All amounts in thousands, except share, ADS, per share and per ADS data) Three Months EndedSix Months EndedJune 30, 2024March 31, 2025June 30, 2025June 30, 2025June 30, 2024June 30, 2025June 30, 2025RMBRMBRMBUS$ (1)RMBRMBUS$ (1) (Loss) income from operations (119,565)(26,142)14,2461,989(286,504)(11,896)(1,661) Adjusted operating (loss) income (non-GAAP) (119,565)(26,142)14,2461,989(286,504)(11,896)(1,661) Net (loss) income (49,169)(79,612)37,8295,281(137,122)(41,783)(5,833) Add:Share of income (loss) in equity method investments 2,727181(3,088)(431)4,988(2,907)(406) Impairment losses and fair value adjustments oninvestments (2) 94358,554(9,463)(1,321)94349,0916,853 Adjusted net (loss) income (non-GAAP) (45,499)(20,877)25,2783,529(131,191)4,401614 Net (loss) income attributable to DouYu (49,169)(79,612)37,8295,281(137,122)(41,783)(5,833) Add:Share of income (loss) in equity method investments 2,727181(3,088)(431)4,988(2,907)(406) Impairment losses and fair value adjustments oninvestments 94358,554(9,463)(1,321)94349,0916,853 Adjusted net (loss) income attributable to DouYu (45,499)(20,877)25,2783,529(131,191)4,401614 Adjusted net (loss) income per ordinary share (non-GAAP) Basic (1.46)(0.69)0.840.12(4.17)0.150.02 Diluted (1.46)(0.69)0.840.12(4.17)0.150.02 Adjusted net (loss) income per ADS(3)(non-GAAP) Basic (1.46)(0.69)0.840.12(4.17)0.150.02 Diluted (1.46)(0.69)0.840.12(4.17)0.150.02 Weighted average number of ordinary shares used in calculating Adjusted net (loss) income per ordinary share Basic 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Diluted 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Weighted average number of ADS used in calculating net (loss) income per ADS(2) Basic 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859 Diluted 31,128,54430,178,85930,178,85930,178,85931,467,86230,178,85930,178,859(1) Translations of certain RMB amounts into U.S. dollars at a specified rate are solely for the convenience of the reader. Unless otherwise noted, alltranslations from RMB to U.S. dollars are made at a rate of RMB7.1636 to US$1.00, the noon buying rate in effect on June 30, 2025, in the H.10 statistical release of the Federal Reserve Board. (2) Impairment losses and fair value adjustments on investments were included in line item "Other expenses, net" of condensed consolidated statements ofincome (loss). (3) Each ADS represents one ordinary share. View original content: SOURCE DouYu International Holdings Limited Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
