Clinical Development and Product Pipeline - Sirnaomics achieved significant clinical data for core products STP705 and STP707, with STP705 in Phase IIb for isSCC and Phase II for BCC, demonstrating notable safety and positive anti-tumor efficacy in Phase I trials[13]. - The IND application for the first GalAhead™ product STP122G for anticoagulation treatment has been successfully approved, marking a key milestone for the company[13]. - Sirnaomics is reallocating resources to focus on advancing the STP705 asset into late-stage clinical development while pausing the fibrosis project until sufficient funding is secured[13]. - Sirnaomics is advancing a medical aesthetics project using STP705 for fat reduction, which has significant market potential[13]. - The company anticipates a fruitful 2023 as it progresses tumor projects into late-stage clinical development[13]. - STP705 achieved a 78% histological clearance rate in treating isSCC, with a minimum dose group showing an 89% clearance rate[19]. - In the BCC trial, STP705 demonstrated a 100% complete response rate at a dose of 180 μg, with excellent safety[19]. - STP707's mid-stage data indicated good safety and efficacy in treating advanced solid tumors, with a maximum dose of 36 mg still showing excellent safety[19]. - The company plans to submit an IND application for STP122G targeting coagulation factor XI to the FDA, expecting approval in April 2023[22]. - Sirnaomics is advancing the GalAheadTM technology based on positive data from a 33-week non-human primate study[19]. - The company is exploring combination therapy of immune checkpoint inhibitors with STP707, aiming for first or second-line treatment in 2023[20]. - The company has initiated a clinical trial for a fat remodeling product, with promising preclinical data expected to yield mid-stage results in Q2 2023[19]. - The company is in communication with the FDA regarding the Phase III clinical study plans for STP705 and BCC treatment in the second half of 2023[19]. - The company is advancing multiple clinical projects, including STP705 and STP707, with nine clinical trials currently ongoing in the United States[29][30]. - The company is developing new candidates for various diseases, including STP125G for hypercholesterolemia and STP144G for complement-mediated diseases, both currently in IND preparation[23][30]. - STP705 is a sterile lyophilized drug targeting TGF-ß1 and COX-2, developed for various cancer treatments including NMSC and liver tumors[32]. - STP707, also a sterile lyophilized drug, is currently in clinical studies for solid tumors and potential pulmonary fibrosis, utilizing a different proprietary nanoparticle delivery system[33]. - The company is evaluating multiple innovative siRNA molecules across various therapeutic indications, including cancers and cardiovascular diseases, with plans to support IND submissions in multiple countries[34]. - STP355 targets both TGF-ß1 and VEGFR2, showing therapeutic potential in various cancer models such as breast cancer and melanoma[36]. - STP122G, targeting factor XI, has shown sustained target silencing activity for up to 28 weeks in animal models, with IND submitted to the FDA[37]. - STP125G, targeting ApoC3, is under development for rare lipid metabolism disorders, with plans to submit an IND to the FDA in 2023[38]. - STP144G targets complement factor B and is being developed for immune-mediated diseases, with non-clinical toxicology studies initiated[39]. Financial Performance and Funding - Sirnaomics reported other income of $2,114,000 in 2022, a significant increase from $350,000 in 2021, representing a growth of 503%[26]. - The company incurred a net loss of $97,378,000 in 2022, an improvement compared to a net loss of $215,934,000 in 2021, indicating a reduction of approximately 55%[26]. - The total non-current assets of Sirnaomics reached $46,682,000 in 2022, compared to $16,842,000 in 2021, reflecting a substantial increase of 177%[26]. - The total liabilities of Sirnaomics decreased from $210,288,000 in 2021 to $111,560,000 in 2022, indicating a reduction of approximately 47%[26]. - For the fiscal year ended December 31, 2022, the company reported a net loss of $97.4 million, a significant improvement from a net loss of $215.9 million for the fiscal year ended December 31, 2021, representing a reduction of 55%[70]. - Other income increased to $2.1 million for the fiscal year ended December 31, 2022, up 504% from $0.4 million for the fiscal year ended December 31, 2021, primarily due to government grants and interest income[71]. - The fair value change of financial liabilities measured at fair value through profit or loss showed a loss of $6.1 million for the fiscal year ended December 31, 2022, a decrease of 96% from a loss of $146.0 million for the fiscal year ended December 31, 2021[73]. - Research and development expenses rose to $67.6 million for the fiscal year ended December 31, 2022, an increase of 66% from $40.7 million for the fiscal year ended December 31, 2021, driven by increased spending on chemical, manufacturing, and clinical trials[77]. - Administrative expenses increased by 50% to $24.2 million for the fiscal year ended December 31, 2022, compared to $16.1 million for the fiscal year ended December 31, 2021, mainly due to professional and consulting fees[75]. - The company did not generate any revenue from product sales or from the co-development and licensing agreement with Watson for the fiscal year ended December 31, 2022[71]. - The company’s financial costs increased by 135% to $0.8 million for the fiscal year ended December 31, 2022, compared to $0.3 million for the fiscal year ended December 31, 2021, primarily due to increased lease liabilities[80]. - The company has not recognized any tax provisions for the fiscal year ended December 31, 2022, due to the absence of taxable profits[81]. - The group's annual loss decreased from $215.9 million for the year ended December 31, 2021, to $97.4 million for the year ended December 31, 2022, primarily due to a reduction in fair value losses on financial liabilities and listing expenses, partially offset by increased R&D and administrative expenses[82]. - Net cash used in operating activities increased by $31.7 million or 56% from $56.9 million for the year ended December 31, 2021, to $88.7 million for the year ended December 31, 2022, mainly due to expanded R&D and administrative activities[83]. - Net cash used in investing activities increased by $26.6 million or 440% from $6.0 million for the year ended December 31, 2021, to $32.6 million for the year ended December 31, 2022, primarily due to increased purchases of financial assets and property, plant, and equipment[84]. - Net cash provided by financing activities decreased by $155.1 million or 91% from $171.0 million for the year ended December 31, 2021, to $15.9 million for the year ended December 31, 2022, mainly due to a reduction in capital raised[85]. - Cash and cash equivalents decreased from $212.0 million as of December 31, 2021, to $105.2 million as of December 31, 2022, primarily due to expanded R&D and administrative activities[86]. - The current ratio decreased from 1,379.1% as of December 31, 2021, to 824.1% as of December 31, 2022, indicating a decline in liquidity[88]. - The group subscribed to an investment fund with a total subscription amount of $15 million, providing an opportunity to enhance returns on idle cash and participate in securities markets[89]. - As of December 31, 2022, the group had no significant acquisitions or disposals of subsidiaries or joint ventures[90]. - The total employee compensation cost for the year ended December 31, 2022, was $21.6 million, down from $24.7 million for the year ended December 31, 2021[92]. - The company has faced net losses since its inception and anticipates continuing to incur net losses in the foreseeable future[127]. - The company has recorded a net cash outflow from operating activities since its establishment, indicating a potential need for additional financing to support business operations[127]. Strategic Partnerships and Market Expansion - The company is targeting the global market for its products, with a particular focus on the United States and Asia for clinical trials and regulatory approvals[28]. - The company is exploring partnerships for next-generation PNP formulation technologies to support future commercialization efforts[45]. - The company is exploring global and local partnerships to maximize the potential of its clinical candidates, particularly STP705 and STP707[66]. - Sirnaomics aims to submit IND applications for two GalAhead™ candidates (STP122G and STP125G) in 2023, with STP122G expected to be the first candidate to enter clinical stages[66]. - The company is actively recruiting participants for global multi-center trials targeting isSCC and liver cancer[64]. - Sirnaomics Ltd. is pursuing market expansion strategies, including partnerships with three major pharmaceutical companies to enhance distribution channels[108]. - The company is committed to expanding its clinical pipeline and exploring collaboration opportunities to enhance market coverage[66]. Governance and Management - The management team is committed to strengthening global business development to drive the company's growth in the RNA therapy market[25]. - The management team includes experienced professionals with backgrounds in clinical medicine, research, and corporate governance[96][99]. - The board is actively involved in formulating the company's business plans and strategies to drive growth[100]. - The company has a strong focus on corporate governance, with independent directors involved in major decision-making processes[104]. - The board consists of 10 directors, including 4 executive directors, 2 non-executive directors, and 4 independent non-executive directors[117]. - The board has full discretion to manage the pre-IPO equity incentive plan, including determining the type and number of rewards granted to participants[142]. - The board has the exclusive right to interpret and determine the terms of the restricted share unit plan, including the allocation of rewards to senior and junior participants[159]. - The board includes members with significant academic and research backgrounds, contributing to the company's scientific and operational strategies[103]. - The company has established a legal advisory role to navigate corporate financing and intellectual property disputes effectively[105]. - The company has received annual confirmations of independence from its independent non-executive directors, affirming their status[121]. Research and Development - The company is expanding its research and development capabilities in RNAi therapeutics, with a focus on new product development[94]. - The company is committed to developing new technologies and products to enhance its competitive edge in the biotechnology market[104]. - The company has several clinical-stage projects focused on siRNA therapeutic products[94]. - The company has benefited from government grants and tax incentives in China, which may be affected by changes in policies or failure to meet conditions[132]. - The biopharmaceutical industry in China is highly regulated, and changes in regulations could impact drug approval and commercialization[132]. Risks and Challenges - The company is subject to significant risks related to the development of its candidate drugs, including the uncertainty of clinical trial outcomes and potential delays in regulatory approvals[124]. - Regulatory approval processes for biopharmaceutical products are lengthy, costly, and unpredictable, which may negatively impact the company's reputation and financial performance[125]. - The company relies on stable and high-quality supply chains for raw materials and services, facing risks from price increases or supply disruptions[127]. - The company faces risks related to intellectual property, including potential competition from third parties if patents are not obtained or maintained effectively[128]. - There is a reliance on third parties for drug development, which could impact regulatory approvals and commercialization if contractual obligations are not met[130]. - The departure of key management team members could delay drug development and adversely affect business performance[131]. Employee Compensation and Incentives - The company adopted a pre-IPO equity incentive plan to attract and retain talent, issuing a total of 12,770,000 shares under this plan[139]. - A total of 12,770,000 shares are reserved for issuance under the pre-IPO equity incentive plan[143]. - The company granted stock options under the pre-IPO equity incentive plan, with a total of 2,675,000 options outstanding as of December 31, 2022[151]. - The company continues to utilize stock options as a key component of its employee compensation strategy[151]. - The company approved a Restricted Share Unit Plan on April 22, 2022, to incentivize skilled personnel and recognize their contributions[155]. - The purpose of the Restricted Share Unit Plan includes recognizing contributions, encouraging retention, and aligning interests with shareholders[156]. - The plan allows for the issuance of shares under general or special authorization granted by shareholders[165]. - The maximum number of shares that can be awarded under the restricted share unit plan is capped at 10% of the issued shares as of the plan's adoption date[163]. - The total number of stock options available for issuance under the stock option plan as of December 31, 2022, was 7,392,373 shares, representing approximately 8.45% of the issued shares[190].
圣诺医药-B(02257) - 2022 - 年度财报