Hypotrichosis Simplex

GERMANTOWN, Md. and SUZHOU BIOBAY, China, Dec. 14, 2022 /PRNewswire/--Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today the interim results of part-one of an ongoing Phase IIb clinical trial of STP705 for the treatment of Cutaneous Squamous Cell Carcinoma In Situ (isSCC). The interim results showed that the majority (78%) of 32 patients with STP705 treatment achieved histological clearance. One of the three treatment cohorts achieved 89% histological clearance. STP705 is an siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down bothTGF-β1 and COX-2 gene expression. The two-part, double-blind, randomized, placebo-controlled Phase IIb study is designed to evaluate the safety and efficacy of various doses of STP705, administered as an intralesional injection in subjects with isSCC. In the part-one of the study, we have treated 32 patients with 30 μg/ml, 60 μg/ml and 90 μg/ml of STP705, respectively, and 12 patients with 0 μg/ml placebo weekly. After six-week repeated dosing, we collected tissue samples from the treatment sites followed by histological analysis. This interim report is specifically for part-one of the study results with a total of 44 patients. Based on our Phase IIb study plan, part-two of this study will include 60 additional subjects who will receive selected doses or placebo for a total of more than 100 subjects. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once a week for a total of six weeks. In the seventh week, the lesion will be excised. "The positive clinical readouts of the part-one study of this Phase IIb trial provide a further validation of our STP705 for treatment of non-melanoma skin cancers." said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "With more clinical results from this study and the cutaneous Basal Cell Carcinoma (BCC) study (Sirnaomics News Release at PR Newswire, August 29, 2022), we feel more enthusiastic about this novel RNAi cancer therapeutics for treatment of Squamous Cell Carcinoma (SCC), addressing a broader unmet patient need." "In our study thus far, patients who received various doses of STP705 over six weeks achieved better histological clearance of isSCC excised lesions than the patients who received a placebo," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "As we move into the latter phase of the clinical trial, we will use this information to determine which doses we deem most effective for treating SCC, which is a type of nonmelanoma skin cancer that affects millions of people in the U.S. Currently, there are only a small number of approved non-surgical treatments that exist for SCC." This interim report of unblinded results of part-one of the Phase IIb study showed that 25 of 32 subjects with STP705 treatment resulted in a high ratio (78%) of histological clearance. Among three treatment cohorts, the 30 μg treatment group (N = 9) achieved the highest histological clearance (89%), while the 60 μg treatment group (N = 12) achieved 75%, and the 90 μg group (N = 11) achieved 73%, which are clearly higher than the placebo group (N = 12) which achieved 58%. There were no treatment-related AE's or SAE's and Local Skin Response Scores were stable or improved across all treatment groups. About Non-melanoma Skin Cancer Non-melanoma skin cancers (NMSC) are the most common forms of human neoplasia. NMSC constitute a large group of skin cancers that are not melanoma, including squamous cell carcinoma (SCC), basal cell carcinoma (BCC), Extramammary Paget's Disease (EMPD), Merkel cell carcinoma (MCC), and skin adnexal carcinomas. Among these, BCC and SCC account for the majority of NMSC with more than 5 million newly diagnosed cases estimated to occur in the U.S. every year. Along with BCC, SCC is one of two major subtypes of NMSC. NMSC treatment market in the U.S. is expected to increase from US$6.5 billion in 2020 to US$22 billion in 2030. In China, the market size of NMSC treatment was US$38 million in 2020 is also expected to grow faster in the coming years, reaching US$149 million in 2030. A World Health Organization authorized report from "International Agency for Research on Cancer" (2019) has demonstrated that the number of deaths in 2018 globally for both men and women from NMSC is 65,155, where the mortality of Asia NMSC subjects represents 41.9% of the global total, which is significantly more than other individual areas. Surgery is currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical aesthetics treatment. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com.

Data results expected to be available in 1H 2023 GAITHERSBURG, Md. and SUZHOU, China, Nov. 7, 2022 /PRNewswire/ -- Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today the Company has dosed the first patient in a Phase I clinical study of STP705, a siRNA (small interfering RNA) drug candidate, for the study of fat reduction in adults undergoing abdominoplasty. In this clinical trial, Sirnaomics has the opportunity to study a leading siRNA therapeutic candidate for medical aesthetics treatment. The dose-ranging, randomized, double-blind, vehicle-controlled study has 10 patients currently enrolled to evaluate the safety and tolerability of STP705, which is administered via subcutaneous injection. The primary endpoints are to assess injection comfort, characterize local and systemic safety, and evaluate histological changes of subcutaneous doses of STP705. The safety and tolerability will be compared among three different concentrations of STP705 (120ug/mL, 240ug/mL, 320ug/mL) to select dosages for future studies. "Currently, the majority of non-invasive procedures approved in the U.S. to abolish fat cells require devices that have mild therapeutic effects and multiple treatment sessions. Our team expects that this dose finding study of STP705 will give key insights into the drugs' effect on fat reduction and subcutaneous tissue remodeling and provide key insights into how this therapeutic can be applied in a safe and effective manner to Medical Aesthetics." said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "This Phase I study will help us mapping out future studies of STP705 for areas of the body that could be treated with non-invasive methods of fat sculpting." Non-invasive fat reduction is a procedure that decreases or eliminates stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. The global market size of non-invasive fat reduction was valued at US$1.1 billion in 2021, with the U.S. having the largest market share, and is anticipated to have an annual growth rate of 16.1% from 2022 to 2030[1]. The Asia Pacific region is expected to outgrow the rest of the world at a pace of 17% over the same period due to factors such as rising obese population, increasing healthcare expenditure, increasing adoption of advanced technology and rising awareness by social media platforms. "A non-invasive fat-reduction option will potentially offer millions of people with submental fat, which is resistant to diet and exercise and influenced by aging and genetics, a unique way to address an all-too-common condition," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "After receiving the green light on an IND in the U.S., we look forward to better understanding how efficacious STP705 can be as a medical aesthetics treatment." Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05422378. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical aesthetics treatment. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at . CONTACT: Michael Molyneaux, M.D., MBA Executive Director and Chief Medical Officer, Sirnaomics Email: MichaelMolyneaux@sirnaomics.com Investor Relations: Nigel Yip, MBA Chief Financial Officer, China, Sirnaomics Email: NigelYip@sirnaomics.com US Media Contact: Mark Corbae Tel: +1 203 682 8288 Email: Mark.Corbae@westwicke.com Asia Media Contact: Bunny Lee Tel: +852 3150 6707 Email: sirnaomics.hk@pordahavas.com Company Codes: HongKong:2257

Data showed an excellent safety profile with no adverse events among the five subjects treated. Company continues to explore doses in the ongoing Phase II dose escalation study GAITHERSBURG, Md and SUZHOU, China, Aug. 29, 2022 /PRNewswire/ -- Sirnaomics Ltd. (the " Company" or " Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the cohort receiving the 180μg dose level in the Phase II clinical trial of STP705 for the treatment of cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment. STP705 is a siRNA (small interfering RNA) therapeutic that is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and COX-2 mRNA, respectively. Apart from achieving a 100% CR, the data among the five subjects treated in the cohort also showed improved or stable cosmetic results with an excellent safety profile (no adverse events) and no significant cutaneous skin reactions. The Company is continuing to explore doses in the ongoing dose escalation study and anticipates a final report in Q1 2023. "The latest results from the Phase II clinical study of STP705 for BCC treatment, showing an incredible efficacy without any drug related AEs and SAEs, further validated the broad potential of this drug candidate for treatment of non-melanoma skin cancers and beyond", said Dr. Patrick Lu, PhD, founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on the successes of both BCC and isSCC (cutaneous squamous cell carcinoma in situ) clinical studies, Sirnaomics is spearheading the development of the novel polypeptide-based siRNA therapeutics for various types of cancers." "Achieving a 100% CR is a clear indication that our treatment has the potential to be an alternative to those treatments currently available to patients, which involve surgical excision of lesions," said Dr. Michael Molyneaux, MD, Executive Director and Chief Medical Officer of Sirnaomics. "To reduce the rate of scarring and achieve a superior cosmetic result compared to surgery could be a potential advantage for patients with BCC and other non-melanoma skin cancers." The Phase II open label, dose escalation study will also expand the number of participating cohorts to continue to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered as localized injections in patients with BCC. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808. About Basal Cell Carcinoma Basal cell carcinoma (BCC) is a type of nonmelanoma skin cancer (NMSC) that is associated with exposure to ultraviolet radiation from the sun. BCC is the most common form followed by squamous cell carcinoma (SCC), and while they have a lower metastatic potential, they can be locally aggressive and destructive of skin and surrounding structures. The estimated metastasis rate of BCC ranges from 0.0029% to 0.55%, and common metastatic sites are regional lymph nodes, lungs, bones, skin, and liver. In the U.S., according to Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012, the number of new cases of BCC is 2.4 million in 2020 and is projected to increase to 4.2 million in 2030. Standard treatments for BCC are standard surgical excision, Mohs micrographic surgery, topical cream treatments, cryosurgery, laser therapy, electro-desiccation, and radiation therapy. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection, and bleeding. Currently, there are two drugs approved by U.S. Food and Drug Administration (FDA) for pre-metastatic BCC patients, which can cause skin reactions in some patients. Treatment of BCC with STP705 shows benefits in cosmetic appearance, especially for patients with lesions on the head, face or neck, and clinical results demonstrate that STP705 has a high complete response compared with currently available topical treatments. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical cosmetology treatment. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at . Contact: Michael Molyneaux, MD, MBA Executive Director and Chief Medical Officer, Sirnaomics Email: [email protected] Investor Relations: Nigel Yip Chief Financial Officer, China, Sirnaomics Email: [email protected] US Media Contact: Mark Corbae Tel: +1 203 682 8288 Email: [email protected] Asia Media Contact: Bunny Lee Tel: +852 3150 6707 Email: [email protected] SOURCE Sirnaomics Ltd.