硕迪生物 2023 年第一季度财务报告及近期亮点
Oral GLP-1 agonist GSBR-1290 advancing into Phase 2a study in type 2 diabetes and obesity
用于治疗 2 型糖尿病和肥胖症的口服 GLP-1 激动剂 GSBR-1290 项目已推进到临床2a期。
Topline data from Phase 1b multiple ascending dose and Phase 2a studies of GSBR-1290 expected in second half 2023
预计 2023 年下半年将获得GSBR-1290临床1b期多次递增剂量和临床2a期的关键数据
SAN FRANCISCO and SHANGHAI, China, May 19, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and pulmonary diseases, today reported financial results for the first quarter ended March 31, 2023, and highlighted recent corporate achievements.
旧金山和上海—2023 年 5 月 11 日—硕迪生物技术有限公司（纳斯达克股票代码：GPCR）是一家临床阶段的全球化生物制药公司，致力于研发治疗代谢性和肺部疾病的新型口服小分子药物。今日，硕迪生物公布了2023年第一季度财务报告（截至2023年 3 月 31 日），重点介绍了公司近期取得的进展。
“We are rapidly advancing GSBR-1290, our lead program in our oral GLP-1 franchise,” said Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics. “Type 2 diabetes and obesity are increasing in prevalence worldwide and it is important to provide patients with options for these chronic and difficult-to-manage diseases. We look forward to moving our oral small molecule GSBR-1290 into type 2 diabetes and obesity patients in our Phase 2a study soon.”
“我们正在快速推进 GSBR-1290项目，这是公司口服 GLP-1 系列中的主要项目。”硕迪生物创始人兼首席执行官 Raymond Stevens 博士表示。“在全球范围内，2 型糖尿病和肥胖症的患病率仍在快速增长，对于这些难以控制的慢性疾病，为患者提供更多治疗选择至关重要。我们期待尽快将口服小分子药物GSBR-1290 推进到临床2a期的2 型糖尿病和肥胖症病人当中。”
Recent Highlights and Upcoming Milestones
近期产品亮点和即将达成的里程碑
GSBR-1290: Protocol amendment submitted to U.S. Food and Drug Administration (FDA) to transition to Phase 2a proof-of-concept study. GSBR-1290 is an orally-available, small molecule agonist of the GLP-1 receptor, a validated drug target for the treatment of type 2 diabetes (T2DM) and obesity. The Company has completed dosing in its Phase 1b multiple ascending dose (MAD) study of GSBR-1290 focused on safety, pharmacokinetics and tolerability in 24 healthy volunteers, and has submitted a protocol amendment to transition to a Phase 2a proof-of-concept study in T2DM and obesity. Topline data from the Phase 1b MAD and Phase 2a studies are expected in the second half of 2023.
GSBR-1290：公司已向美国食品药品监督管理局（FDA）提交了临床试验方案修订，以过渡到临床2a期的概念验证研究。GSBR-1290 是一种口服的 GLP-1 受体小分子激动剂，该受体是治疗 2 型糖尿病 (T2DM) 和肥胖症的有效药物靶点。公司已经完成了对GSBR-1290 多次递增剂量 (MAD) 的临床1b期研究，对包括 24 名健康受试者的安全性、药代动力学和耐受性进行了剂量测试，并已提交了临床试验方案修订，以进入 T2DM 和肥胖症的临床2a期概念验证研究。预计将于 2023 年下半年可获得临床1b 期多次递增剂量和临床2a 期研究数据。
First Quarter 2023 Financial Highlights
2023 年第一季度财务亮点
Cash Position: Cash, cash equivalents and short-term investments totaled $240.9 million at March 31, 2023. The Company expects its current cash, cash equivalents and short-term investments to fund operations through expected key clinical milestones through the end of 2025.
现金状况：截至 2023 年 3 月 31 日，现金、现金等价物和短期投资收益总计 2.409 亿美元。基于对直至 2025 年底的关键临床里程碑的预期，公司预计当前的现金、现金等价物和短期投资收益可为其提供充足的运营资金。
R&D Expenses: Research and development expenses were $13.1 million for the first quarter ended March 31, 2023, as compared to $8.5 million for the same period in 2022. The increase during the quarter was primarily due to the advancement of the Company’s GLP-1R franchise and other research programs and increases related to personnel expenses primarily due to stock-based compensation expense.
研发费用：截至 2023 年 3 月 31 日，公司第一季度研发费用总计 1,310 万美元，2022 年同期为 850 万美元。本季度研发费用增加的主要原因是公司 GLP-1R系列项目和其他研发项目的推进，以及员工成本的增加，其中股权薪酬费用是主要原因。
G&A Expenses: General and administrative expenses were $6.5 million for the first quarter ended March 31, 2023, as compared to $4.5 million for the same period in 2022. The increase during the quarter was primarily due to an increase in personnel costs related to increased stock-based compensation expense and headcount and an increase in professional service fees and other costs associated with operating as a publicly-traded company.
管理费用：截至 2023 年 3 月 31 日，公司第一季度的管理费用总计 650 万美元，2022 年同期为 450 万美元。该项费用增加的主要原因是人员成本的增加，包括股权薪酬费用和员工数量的增加，以及公司上市准备过程中产生的专业服务费与其他相关费用。
Net Loss: Net loss totaled $18.0 million for the first quarter of 2023 with non-cash stock-based compensation expense of $2.5 million, compared to $13.1 million for the first quarter of 2022 with non-cash stock-based compensation expense of $0.6 million.
净亏损：2023 年第一季度净亏损总计 1,800 万美元，其中非现金股权薪酬费用为 250 万美元，2022 年同期净亏损为 1,310 万美元，非现金股权薪酬费用为 60 万美元。
About Structure Therapeutics
关于硕迪生物
Structure Therapeutics is a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative oral treatments for chronic metabolic and pulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the company has established a scientifically-driven, GPCR-targeted pipeline, featuring two wholly-owned proprietary clinical-stage small molecule compounds designed to surpass the limitations of traditional biologic and peptide therapies and be accessible to more patients around the world. For additional information, please visit www.structuretx.com.
硕迪生物是一家领先的临床阶段生物制药公司，致力于研发治疗多种慢性、代谢性和肺部疾病的新型口服治疗药物，解决市场上未被满足的医疗需求。利用新一代基于结构的药物发现平台，公司已经构建了以科学为导向的 GPCR 靶向研发管线，涵盖两种全资专有的临床阶段小分子化合物，克服了传统生物制剂和肽类疗法的局限，为全球范围内越来越多的患者提供治疗。了解更多信息，请访问www.structuretx.com。
Forward Looking Statements
前瞻性声明
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects, the Company’s anticipated cash runway, any expectations regarding the safety or efficacy of GSBR-1290 and other candidates under development, the ability of GSBR-1290 to treat type 2 diabetes, obesity or related indications, plans with respect to regulatory submissions, the planned timing of the Company’s clinical trials, data results and continued development of GSBR-1290 and expectations regarding an oral development candidate targeting GLP-1R. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact of the ongoing COVID-19 pandemic, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2023, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
本新闻稿所作出的前瞻性陈述，包含 1995 年《美国私人证券诉讼改革法案》“安全港”条款界定的前瞻性表述。除过往事实陈述外，所有陈述均可视为前瞻性陈述，包括但不限于以下内容：公司未来的计划和前景，公司预期的现金流失，对 GSBR-1290 及其它研发中的候选药物的安全性或有效性的预期，GSBR-1290 治疗 2 型糖尿病、肥胖症或相关适应症的功效，注册申报相关计划，公司临床试验的时间线和计划，GSBR-1290 项目的数据、结果和持续研发，以及对靶向 GLP-1R 的口服开发候选药物的预期。另外，当本新闻稿中使用或如果在本新闻稿中使用“可能”、“可以”、“应该”、“预计”、“相信”、“估计”、“预期”、“打算”、“计划”、“预测”等其它类似表述时，由于涉
及的内容和公司有关，因此可能会被认定为前瞻性陈述。前瞻性陈述既非过往事实，也不是对未来业绩的保证。尽管公司认为此类前瞻性陈述中反映的预期具有合理性，但并非是对未来表现的担保和保证。公司提醒读者细阅本文，实际结果、活性强度、安全性、药效或其它情况可能受各种重要因素的影响而与前瞻性陈述中表述或包含的信息存在重大差异，这些风险和不确定性因素包括但不限于：（1.）与公司推进 GSBR-1290、LTSE-2578、ANPA-0073 及其它候选治疗药物相关的不确定性和风险；（2.）公司获得候选治疗药物的监管审批并最终使药物商业化的不确定性和风险；（3.）临床前和临床试验时间线和结果的不确定性和风险；（4.）公司用于研发活动和实现研发目标的资金能力的风险和不确定性；（5.）COVID-19 大流行、通货膨胀、供应链问题、上升的利率和未来银行破产对公司业务的影响；（6.）公司保护自身知识产权能力的不确定性和风险；以及（7.）公司向美国证券交易委员会 ("SEC") 提交的文件中描述的其他风险和不确定性，包括公司于 2023 年 3 月 30 日向美国证券交易委员会 ("SEC")提交的10-K表格年度报告以及公司未来不时向美国证券交易委员会 ("SEC") 提交的报告中指出的其它因素。本新闻稿中所作出的所有前瞻性陈述仅代表截至发布日期时，管理层对经营情况的假设和估计。除法律规定外，无论是出于新信息、未来事件或其它原因，公司均无义务更新或修订任何前瞻性陈述。
STRUCTURE THERAPEUTICS INC.
硕迪生物技术有限公司
Condensed Consolidated Statements of Operations
简明综合财务报表
(unaudited)
（未经审计）
(In thousands, except per share amounts)
（以千计，每股数额除外）
| THREE MONTHS ENDED 3 个月截至 | ||||||||
| MARCH 31, 3 月 31 日 | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: 营业费用： | ||||||||
| Research and development 研发费用 | $ 美元 | 13,135 | $ 美元 | 8,492 | ||||
| General and administrative 管理费用 | 6,514 | 4,460 | ||||||
| Total operating expenses 营业费用合计 | 19,649 | 12,952 | ||||||
| Loss from operations 营业亏损 | (19,649 | ) | (12,952 | ) | ||||
| Interest and other income (expense), net 利息和其他收入（费用），净额 | 1,699 | (69 | ) | |||||
| Loss before provision for income taxes 扣除所得税准备前的亏损 | (17,950 | ) | (13,021 | ) | ||||
| Provision for income taxes 所得税准备 | 25 | 60 | ||||||
| Net loss attributable to ordinary shareholders 归属于普通股股东的净亏损 | $ 美元 | (17,975 | ) | $ 美元 | (13,081 | ) | ||
| Net loss per share attributable to ordinary shareholders, basic and diluted 归属于普通股股东的每股净亏损，基本及稀释 | $ 美元 | (0.25 | ) | $ 美元 | (1.44 | ) | ||
| Weighted-average ordinary shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted 加权平均普通股，用于计算归属于普通股股东的每股净亏损，基本及稀释 | 71,655 | 9,063 | ||||||
STRUCTURE THERAPEUTICS INC.
硕迪生物技术有限公司
Condensed Consolidated Balance Sheet Data
简明合并资产负债数据表
(unaudited)
（未经审计）
(In thousands)
（以千计）
| MARCH 31, 3 月 31 日 | DECEMBER 31, 12 月 31 日 | ||||||
| 2023 | 2022 | ||||||
| Assets 资产 | |||||||
| Current assets: 流动资产： | |||||||
| Cash, cash equivalents and short-term investments 现金、现金等价物和短期投资 | $ 美元 | 240,862 | $ 美元 | 90,841 | |||
| Prepaid expenses and other current assets 预付费用和其他流动资产 | 5,293 | 2,248 | |||||
| Total current assets 流动资产合计 | 246,155 | 93,089 | |||||
| Property and equipment, net 资产和设备，净额 | 961 | 1,031 | |||||
| Operating right-of-use assets 经营使用权资产 | 178 | 262 | |||||
| Other non-current assets 其他非流动资产 | 59 | 3,463 | |||||
| Total assets 资产合计 | $ 美元 | 247,353 | $ 美元 | 97,845 | |||
| Liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit) 负债、可赎回可转换优先股和股东权益（亏损） | |||||||
| Current liabilities: 流动负债： | |||||||
| Accounts payable 应付账款 | $ 美元 | 4,945 | $ 美元 | 6,009 | |||
| Accrued expenses and other current liabilities 预提费用和其他流动负债 | 5,889 | 6,741 | |||||
| Operating lease liabilities, current portion 经营租赁负债，一年内到期的部分 | 168 | 260 | |||||
| Total current liabilities 流动负债合计 | 11,002 | 13,010 | |||||
| Total liabilities 负债合计 | 11,002 | 13,010 | |||||
| Redeemable convertible preferred shares issuable in series 系列发行的可赎回可转换优先股 | — | 199,975 | |||||
| Total shareholders’ equity (deficit) 股东权益合计（亏损） | 236,351 | (115,140 | ) | ||||
| Total liabilities, redeemable convertible preferred shares and shareholders’ equity (deficit) 负债、可赎回可转换优先股和股东权益（亏损）合计 | $ 美元 | 247,353 | $ 美元 | 97,845 | |||
Contacts:
联系人：
Investors:
投资人：
Jun Yoon, Chief Financial Officer
Jun Yoon，首席财务官
Structure Therapeutics Inc.
硕迪生物技术有限公司
ir@structuretx.com
Media:
媒体合作：
Dan Budwick
1AB
Dan@1abmedia.com
