View ValuationSionna Therapeutics 향후 성장Future 기준 점검 2/6Sionna Therapeutics 의 수익은 연간 12.5% 감소할 것으로 예상되는 반면, 연간 수익은 71.2% 로 증가할 것으로 예상됩니다. EPS는 연간 5.7% 만큼 쇠퇴할 것으로 예상됩니다. 자기자본이익률은 3년 후 -41% 로 예상됩니다.핵심 정보-12.5%이익 성장률-5.73%EPS 성장률Biotechs 이익 성장25.3%매출 성장률71.2%향후 자기자본이익률-40.97%애널리스트 커버리지Good마지막 업데이트20 May 2026최근 향후 성장 업데이트업데이트 없음모든 업데이트 보기Recent updates속보 • May 14Sionna Therapeutics Eyes Key 2026 Trial Results With Strong Cash and Analyst SupportSionna Therapeutics completed enrollment in its Phase 2a PreciSION CF trial evaluating NBD1 stabilizer SION-719 as an add-on therapy for cystic fibrosis, with topline data from this study and a Phase 1 dual-combination trial with SION-451 expected in summer 2026. The company reported a Q1 2026 net loss of $26.8 million, or $0.60 per share, and held cash and equivalents of $289.9 million, which management projects is sufficient to fund operations into 2028. Director Peter Thompson and OrbiMed Advisors each sold roughly $13.3 million of Sionna stock under pre-arranged trading plans, while several research firms reiterated positive ratings and price targets up to $53 following the earnings update and trial progress. The key swing factor for Sionna over the next two years is the paired readout from SION-719 and the SION-719 / SION-451 combination. These data could materially influence how the pipeline and funding runway are perceived. Insider sales under trading plans do not automatically signal a change in company fundamentals. However, they are worth tracking alongside clinical milestones and cash usage as you assess risk and potential dilution over time.공시 • Apr 30Sionna Therapeutics Inc Completes Enrollment in Precision Cf Phase 2A Trial Evaluating Nbd1 Stabilizer Sion-719 Added to Standard of Care in Participants with Cystic FibrosisSionna Therapeutics, Inc. announced the completion of enrollment in the PreciSION CF Phase 2a proof-of-concept (POC) trial. This trial is evaluating SION-719, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, when added to Trikafta (elexacaftor/tezacaftor/ivacaftor), the current standard of care (SOC) in CF. Sionna anticipates data from the PreciSION CF trial in the summer of 2026. The PreciSION CF Phase 2a trial (NCT07108153) is a randomized, double-blind, placebo-controlled, crossover POC study that enrolled adult CF patients homozygous for F508del on a stable dose of physician-prescribed Trikafta. The objectives of the trial are to evaluate the safety, tolerability, and pharmacokinetics of SION-719 when administered with SOC and to assess change in sweat chloride levels, an important measure of CFTR function. The PreciSION CF trial is being conducted at multiple sites, including sites in the CF Foundation-supported Therapeutics Development Network (TDN), the largest CF clinical trials network in the world.공시 • Apr 29Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026.Seeking Alpha • Nov 07Sionna Therapeutics Q3 2025: Advancing CF Pipeline Toward Proof-Of-ConceptSummary Sionna Therapeutics reported a narrowed GAAP EPS loss and maintains a strong $325M cash position, funding operations through 2028. SION advanced its cystic fibrosis pipeline, launching Phase 2a for SION-719 and Phase 1 for SION-451, with topline data expected mid-2026. The stock has surged 44% since the previous buy call, driven by pipeline momentum and investor confidence in its NBD1 stabiliser programs. Despite the recent pullback from $42 to $35, SION presents continued upside potential ahead of key clinical catalysts in 2026. Read the full article on Seeking Alpha공시 • Oct 25Sionna Therapeutics Announces Presentation of SION-719 and SION-451 Phase 1 Data and Poster of New Preclinical Data on the Impact of NBD1 Stabilizer on F508del-CFTR Half-Life at the 2025 North American Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced data presented at the 2025 North American Cystic Fibrosis Conference (NACFC) being held in Seattle, Washingt on October 22-25. Jason H. Maley, M.D., MS, Senior Director of Clinical Development at Sionna, presented data from the two Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers. The randomized, double-blind, placebo-controlled Phase 1 trials enrolled over 200 healthy volunteers and evaluated each compound's safety, tolerability, and pharmacokinetics (PK) across single and multiple ascending dose cohorts. As previously disclosed, Sionna's two Phase 1 trials demonstrated that both SION-719 andSION-451 were generally well tolerated and exceeded target exposure levels. Based on these Phase 1 data and its cystic fibrosis human bronchial epithelial (CFHBE) model, Sionna believes that its NBD1 stabilizers have the potential to deliver clinically meaningful benefit when SION-719 is added to the standard of care (SOC) or when SION-451 is used in proprietary dual combinations with one of Sionna's complementary modulators. The Phase 1 data also supported the use of a tablet formulation in future trials and indicated that both compounds can be dosed in a fed or fast state. In a poster presented by Greg Hurlbut, Ph.D., Co-Founder and Senior Vice President of Discovery Research at Sionna, new preclinical data from metabolic pulse-chase labeling studies show the impact of Sionna's NBD1 stabilizers on the half-life of F508del-CFTR protein, in the presence and absence of Sionna's complementary CFTR modulators. In these studies, NBD1 stabilizers SION-719 and NBD1 stabilizers Sionna-719 and SION -451 increased the half-life of mature F508del-CFTR proteins to levels seen with wild-type CFTR. This effect was apparent even when NBD1 stabilizers were used as single agents. The most common CFTR mutation that causes CF is F508del, which results in the instability of CFTR's NBD1 domain and impaired CFTR folding, trafficking, half-life, and function," said Dr. Hurlbut. The minimal amount of F508del-CF TR protein that does reach the apical cellular membrane exhibits a dramatically increased rate ofdegradation and decreased half-life relative to wild-type CFTR. The company have previously previously announced that the NBD1 stabilizers are currently being evaluated in the Phase 1 data in the clinical trial.공시 • Sep 09Sionna Therapeutics, Inc Appoints Caroline Stark Beer as Chief Business OfficerSionna Therapeutics, Inc. announced the appointment of Caroline Stark Beer, MBA, as its Chief Business Officer (CBO). Caroline brings over 20 years of experience in the life science industry to her role with Sionna. She was most recently CBO at Jnana Therapeutics until Jnanas sale to Otsuka Pharmaceutical. Caroline led the team responsible for corporate and business development, alliance management, legal contracts, new product planning, and communications. Before Jnana, she spent over a decade at Alnylam Pharmaceuticals; in her final role there, she served as VP of Business Development. During this time, she led the formation of a variety of high-impact partnerships including a 5-year collaboration with Regeneron Pharmaceuticals to discover and develop new RNA interference (RNAi) therapeutics. Prior to Alnylam, Caroline served in business development at Amicus Therapeutics and started her career as a strategy consultant at Bain &Company. Caroline received her MBA from the MIT Sloan School of Management and a Bachelor of Economics from Duke University.공시 • Aug 25Sionna Therapeutics Announces First Subjects Dosed in Phase 1 Trial Evaluating NBD1 Stabilizer, SION-451, in Proprietary Dual Combinations in Development for the Treatment of Cystic FibrosisSionna Therapeutics, Inc. announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intrracellular loop 4 (ICL4)-directed CFTR corrector. This Phase 1 trial is a randomized, double-blind, placebo-controlled trial in healthy volunteers. It is designed to assess the safety, tolerability, and pharmacokinetics (PK) of varying doses of dual combinations of SION-2222 and SION-109 with SION-109. Topline data are anticipated in mid-2026, and will inform selection of a dual combination for a planned Phase 2b trial in people living with CF. CF is a progressive and life-threatening genetic disease that affects more than 100,000 people globally. While advances in the discovery and development of modulators have significantly improved the lives of people living with CF, at least two-thirds of patients on the current standard of care do not have normal CFTR function as measured by levels of sweat chloride. The NBD1 domain of the CFTR protein plays a critical role in the folding, stability and trafficking of CFTR to a cell's surface, but no approved CF therapies directly stabilize NBD1. Positive data from Phase 1 clinical trials and preclinical data support the mechanistic rationale and advancement of this dual combination trial. In its recent Phase 1 trial, SION-451 was generally well tolerated and exceeded PK concentration targets that Sionna believes, based on its preclinical CF human bronchialhelial (CFHBE) model, indicate the potential to provide clinically meaningful benefit, including the potential for wild-type levels of CFTR function, in proprietary dual combinations with complementary modulators.분석 기사 • Aug 24Here's Why We're Not Too Worried About Sionna Therapeutics' (NASDAQ:SION) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • Jun 18Sling Therapeutics, Inc. Appoints Ken Lock as Chief Commercial OfficerSling Therapeutics, Inc. announced the appointment of Ken Lock as Chief Commercial Officer. Lock brings over 20 years of commercial leadership experience as Sling prepares for a confirmatory Phase 3 study of linsitinib. Most recently, Lock served as Chief Commercial Officer at ACELYRIN, where he led the commercial, medical affairs, and alliance management functions in the TED market. Lock also served as Chief Commercial Officer at Arcutis Biotherapeutics, where he built and led a team of over 130 people and was responsible for the launch and brand development of ZORYVE®. Prior to that, he held sales and marketing roles of increasing responsibility at Gilead Sciences, Amgen, and Wyeth (now Pfizer). Lock holds an M.B.A. from the Cornell Johnson Graduate School of Management and a dual B.S. and B.A. in Biochemistry/Cell Biology and Psychology from the University of California, San Diego.공시 • Jun 07Sionna Therapeutics, Inc. Announces Presentation of Preclinical Data That Demonstrate Proprietary Dual Combination Therapies Enable Full CFTR Correction in CFHBE ModelSionna Therapeutics, Inc. announced the presentation of preclinical data that demonstrate that the company's nucleotide-binding domain 1 (NBD1) stabilizers, in dual combinations with proprietary complementary modulators, enable full CFTR correction in CF models. The data are featured in an oral presentation and poster session at the European Cystic Fibrosis Society (ECFS) 48thEuropean Cystic Fibrosis Conference being held in Milan, Italy. Preclinical data suggest these compounds, when used in combination, have the potential to dramatically improve clinical outcomes and quality of life for people with CF." Sionna has completed Phase 1 clinical trials evaluating two potent first-in-class small molecule NBD1 stabilizers, SION-719 and SION-451. The company is also developing modulators with mechanisms of action that are complementary to NBD1, including SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. In the CFHBE model, SION-719 & SION-451 dual combinations also show potential for clinically meaningful improvement including to wild-type levels at concentrations below Emax. Earlier this week, Sionna announced its plans to advance SION-719 andSION-451 to the next stage of clinical development. The company plans to evaluate SION-719 in a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to standard of care (SOC), and SION-451 in a Phase 1 healthy volunteer trial evaluating SION-451 in two dual combinations with SION-2222 and with SION-109. Both trials are expected to initiate in the second half of 2025, with data anticipated in mid-2026.공시 • Jun 04Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic FibrosisSionna Therapeutics, Inc. announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers. Sionna plans to advance both NBD1 stabilizers to the next stage of clinical development -- SION-719 to a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to SOC, and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719, and SION-451 in healthy volunteers. SionNA is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add- on to SOC and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. Positive Phase 1 Results for SION-719 and SION-451: The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719 and SION-451 in healthy volunteers. The effect of food on the PK and the bioequivalence of a tablet formulation was also evaluated in Part C of each trial. 100 subjects were dosed in the SION-719 trial and 110 subjects were dosed in the SION-451 trial. Both compounds were generally well tolerated in the Phase 1 trials. There were no serious adverse events, treatment emergent adverse events (TEAEs) that led to discontinuation of drug, or dose-limiting TEAEs observed. Most TEAEs were mild to moderate (Grade 1 or Grade 2). There was one Grade 1 TEAE related to liver function tests (LFTs) in a SION-451 treated subject who tested positive for influenza; no TEAEs related to LFTs were observed in the other cohorts of SION-451. There were no TEAEs related to LFTs in SION-719 treated subjects. The data from Part C of each trial support the use of a tablet formulation in future studies and indicate that both compounds can be dosed in a fed or fasted state. SION-719 and SION-451 each achieved desired target PK concentrations at multiple dose levels in a twice daily regimen. Both stabilizers met exposure thresholds that, based on Sionna’s preclinical CFHBE model, have the potential to provide clinically meaningful benefit if administered as an add-on to SOC or in a proprietary dual combination with complementary modulators. Next Phase of Clinical Development for NBD1 Stabilizers: SION-719 to Advance to Phase 2a Proof-of-concept in CF Patients as an Add-on to Standard of Care: Sionna is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add-on to SOC in CF patients. The trial objectives will be to show an improvement in CFTR function as defined by sweat chloride reduction and to demonstrate that NBD1 is mechanistically unique from, and synergistic with, the components of SOC. Sionna is on track to initiate this trial in the second half of 2025 with topline data anticipated in mid-2026. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SION-719, and the first subject has been dosed in a midazolam drug-drug interaction (DDI) study to confirm SION-719 can be dosed in combination with the SOC according to its label. This study will be completed prior to initiation of the Phase 2a trial. SION-451 to Advance to Phase 1 Healthy Volunteer Dual Combination Trial with Complementary Modulators: Sionna plans to initiate a Phase 1 healthy volunteer dual combination trial evaluating SION-451 in combination with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. The trial will assess the safety, tolerability, and PK of varying doses of the dual combinations, and will inform selection of a dual combination for a Phase 2b trial in CF patients. Sionna is on track to initiate the healthy volunteer trial in the second half of 2025 with topline data expected in mid-2026.공시 • May 22Sionna Therapeutics to Present Preclinical Data During Oral Session At the 48Th European Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced that preclinical data assessing combinations of Sionna's nucleotide-binding domain 1 (NBD1) stabilizers, SION-451 and SION-719, with complementary Sionna CFTR modulators, galicaftor (SION-2222) and SION-109, will be featured in an oral presentation at the European Cystic Fibrosis Society's (ECFS) 48thEuropean Cystic Fibrosis Conference, being held June 4-7, 2025 in Milan, Italy.공시 • Apr 30Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025.공시 • Feb 07Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million.Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,588,233 Price\Range: $18 Transaction Features: Sponsor Backed Offering이익 및 매출 성장 예측NasdaqGM:SION - 애널리스트 향후 추정치 및 과거 재무 데이터 (USD Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/20283-163-128-147912/31/20273-138-119-1121012/31/2026N/A-119-114-106103/31/2026N/A-86-72-72N/A12/31/2025N/A-75-67-66N/A9/30/2025N/A-71-62-61N/A6/30/2025N/A-76-64-64N/A3/31/2025N/A-66-56-56N/A12/31/2024N/A-62-53-53N/A9/30/2024N/A-58-49-48N/A12/31/2023N/A-47-45-44N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: SION 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 vs 시장: SION 향후 3년 동안 수익성이 없을 것으로 예상됩니다.고성장 수익: SION 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 대 시장: SION 의 수익(연간 71.2%)이 US 시장(연간 11.7%)보다 빠르게 성장할 것으로 예상됩니다.고성장 매출: SION 의 수익(연간 71.2%)은 연간 20%보다 빠르게 증가할 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: SION는 3년 뒤에도 수익성이 없을 것으로 전망됩니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/22 18:21종가2026/05/22 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Sionna Therapeutics, Inc.는 12명의 분석가가 다루고 있습니다. 이 중 10명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Kambiz YazdiBTIGJonathan WollebenCitizens JMP Securities, LLCIlya ZubkovFreedom Broker9명의 분석가 더 보기
속보 • May 14Sionna Therapeutics Eyes Key 2026 Trial Results With Strong Cash and Analyst SupportSionna Therapeutics completed enrollment in its Phase 2a PreciSION CF trial evaluating NBD1 stabilizer SION-719 as an add-on therapy for cystic fibrosis, with topline data from this study and a Phase 1 dual-combination trial with SION-451 expected in summer 2026. The company reported a Q1 2026 net loss of $26.8 million, or $0.60 per share, and held cash and equivalents of $289.9 million, which management projects is sufficient to fund operations into 2028. Director Peter Thompson and OrbiMed Advisors each sold roughly $13.3 million of Sionna stock under pre-arranged trading plans, while several research firms reiterated positive ratings and price targets up to $53 following the earnings update and trial progress. The key swing factor for Sionna over the next two years is the paired readout from SION-719 and the SION-719 / SION-451 combination. These data could materially influence how the pipeline and funding runway are perceived. Insider sales under trading plans do not automatically signal a change in company fundamentals. However, they are worth tracking alongside clinical milestones and cash usage as you assess risk and potential dilution over time.
공시 • Apr 30Sionna Therapeutics Inc Completes Enrollment in Precision Cf Phase 2A Trial Evaluating Nbd1 Stabilizer Sion-719 Added to Standard of Care in Participants with Cystic FibrosisSionna Therapeutics, Inc. announced the completion of enrollment in the PreciSION CF Phase 2a proof-of-concept (POC) trial. This trial is evaluating SION-719, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, when added to Trikafta (elexacaftor/tezacaftor/ivacaftor), the current standard of care (SOC) in CF. Sionna anticipates data from the PreciSION CF trial in the summer of 2026. The PreciSION CF Phase 2a trial (NCT07108153) is a randomized, double-blind, placebo-controlled, crossover POC study that enrolled adult CF patients homozygous for F508del on a stable dose of physician-prescribed Trikafta. The objectives of the trial are to evaluate the safety, tolerability, and pharmacokinetics of SION-719 when administered with SOC and to assess change in sweat chloride levels, an important measure of CFTR function. The PreciSION CF trial is being conducted at multiple sites, including sites in the CF Foundation-supported Therapeutics Development Network (TDN), the largest CF clinical trials network in the world.
공시 • Apr 29Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026Sionna Therapeutics, Inc., Annual General Meeting, Jun 17, 2026.
Seeking Alpha • Nov 07Sionna Therapeutics Q3 2025: Advancing CF Pipeline Toward Proof-Of-ConceptSummary Sionna Therapeutics reported a narrowed GAAP EPS loss and maintains a strong $325M cash position, funding operations through 2028. SION advanced its cystic fibrosis pipeline, launching Phase 2a for SION-719 and Phase 1 for SION-451, with topline data expected mid-2026. The stock has surged 44% since the previous buy call, driven by pipeline momentum and investor confidence in its NBD1 stabiliser programs. Despite the recent pullback from $42 to $35, SION presents continued upside potential ahead of key clinical catalysts in 2026. Read the full article on Seeking Alpha
공시 • Oct 25Sionna Therapeutics Announces Presentation of SION-719 and SION-451 Phase 1 Data and Poster of New Preclinical Data on the Impact of NBD1 Stabilizer on F508del-CFTR Half-Life at the 2025 North American Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced data presented at the 2025 North American Cystic Fibrosis Conference (NACFC) being held in Seattle, Washingt on October 22-25. Jason H. Maley, M.D., MS, Senior Director of Clinical Development at Sionna, presented data from the two Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers. The randomized, double-blind, placebo-controlled Phase 1 trials enrolled over 200 healthy volunteers and evaluated each compound's safety, tolerability, and pharmacokinetics (PK) across single and multiple ascending dose cohorts. As previously disclosed, Sionna's two Phase 1 trials demonstrated that both SION-719 andSION-451 were generally well tolerated and exceeded target exposure levels. Based on these Phase 1 data and its cystic fibrosis human bronchial epithelial (CFHBE) model, Sionna believes that its NBD1 stabilizers have the potential to deliver clinically meaningful benefit when SION-719 is added to the standard of care (SOC) or when SION-451 is used in proprietary dual combinations with one of Sionna's complementary modulators. The Phase 1 data also supported the use of a tablet formulation in future trials and indicated that both compounds can be dosed in a fed or fast state. In a poster presented by Greg Hurlbut, Ph.D., Co-Founder and Senior Vice President of Discovery Research at Sionna, new preclinical data from metabolic pulse-chase labeling studies show the impact of Sionna's NBD1 stabilizers on the half-life of F508del-CFTR protein, in the presence and absence of Sionna's complementary CFTR modulators. In these studies, NBD1 stabilizers SION-719 and NBD1 stabilizers Sionna-719 and SION -451 increased the half-life of mature F508del-CFTR proteins to levels seen with wild-type CFTR. This effect was apparent even when NBD1 stabilizers were used as single agents. The most common CFTR mutation that causes CF is F508del, which results in the instability of CFTR's NBD1 domain and impaired CFTR folding, trafficking, half-life, and function," said Dr. Hurlbut. The minimal amount of F508del-CF TR protein that does reach the apical cellular membrane exhibits a dramatically increased rate ofdegradation and decreased half-life relative to wild-type CFTR. The company have previously previously announced that the NBD1 stabilizers are currently being evaluated in the Phase 1 data in the clinical trial.
공시 • Sep 09Sionna Therapeutics, Inc Appoints Caroline Stark Beer as Chief Business OfficerSionna Therapeutics, Inc. announced the appointment of Caroline Stark Beer, MBA, as its Chief Business Officer (CBO). Caroline brings over 20 years of experience in the life science industry to her role with Sionna. She was most recently CBO at Jnana Therapeutics until Jnanas sale to Otsuka Pharmaceutical. Caroline led the team responsible for corporate and business development, alliance management, legal contracts, new product planning, and communications. Before Jnana, she spent over a decade at Alnylam Pharmaceuticals; in her final role there, she served as VP of Business Development. During this time, she led the formation of a variety of high-impact partnerships including a 5-year collaboration with Regeneron Pharmaceuticals to discover and develop new RNA interference (RNAi) therapeutics. Prior to Alnylam, Caroline served in business development at Amicus Therapeutics and started her career as a strategy consultant at Bain &Company. Caroline received her MBA from the MIT Sloan School of Management and a Bachelor of Economics from Duke University.
공시 • Aug 25Sionna Therapeutics Announces First Subjects Dosed in Phase 1 Trial Evaluating NBD1 Stabilizer, SION-451, in Proprietary Dual Combinations in Development for the Treatment of Cystic FibrosisSionna Therapeutics, Inc. announced that the first subjects have been dosed in a Phase 1 trial evaluating SION-451, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, in proprietary dual combinations with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intrracellular loop 4 (ICL4)-directed CFTR corrector. This Phase 1 trial is a randomized, double-blind, placebo-controlled trial in healthy volunteers. It is designed to assess the safety, tolerability, and pharmacokinetics (PK) of varying doses of dual combinations of SION-2222 and SION-109 with SION-109. Topline data are anticipated in mid-2026, and will inform selection of a dual combination for a planned Phase 2b trial in people living with CF. CF is a progressive and life-threatening genetic disease that affects more than 100,000 people globally. While advances in the discovery and development of modulators have significantly improved the lives of people living with CF, at least two-thirds of patients on the current standard of care do not have normal CFTR function as measured by levels of sweat chloride. The NBD1 domain of the CFTR protein plays a critical role in the folding, stability and trafficking of CFTR to a cell's surface, but no approved CF therapies directly stabilize NBD1. Positive data from Phase 1 clinical trials and preclinical data support the mechanistic rationale and advancement of this dual combination trial. In its recent Phase 1 trial, SION-451 was generally well tolerated and exceeded PK concentration targets that Sionna believes, based on its preclinical CF human bronchialhelial (CFHBE) model, indicate the potential to provide clinically meaningful benefit, including the potential for wild-type levels of CFTR function, in proprietary dual combinations with complementary modulators.
분석 기사 • Aug 24Here's Why We're Not Too Worried About Sionna Therapeutics' (NASDAQ:SION) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • Jun 18Sling Therapeutics, Inc. Appoints Ken Lock as Chief Commercial OfficerSling Therapeutics, Inc. announced the appointment of Ken Lock as Chief Commercial Officer. Lock brings over 20 years of commercial leadership experience as Sling prepares for a confirmatory Phase 3 study of linsitinib. Most recently, Lock served as Chief Commercial Officer at ACELYRIN, where he led the commercial, medical affairs, and alliance management functions in the TED market. Lock also served as Chief Commercial Officer at Arcutis Biotherapeutics, where he built and led a team of over 130 people and was responsible for the launch and brand development of ZORYVE®. Prior to that, he held sales and marketing roles of increasing responsibility at Gilead Sciences, Amgen, and Wyeth (now Pfizer). Lock holds an M.B.A. from the Cornell Johnson Graduate School of Management and a dual B.S. and B.A. in Biochemistry/Cell Biology and Psychology from the University of California, San Diego.
공시 • Jun 07Sionna Therapeutics, Inc. Announces Presentation of Preclinical Data That Demonstrate Proprietary Dual Combination Therapies Enable Full CFTR Correction in CFHBE ModelSionna Therapeutics, Inc. announced the presentation of preclinical data that demonstrate that the company's nucleotide-binding domain 1 (NBD1) stabilizers, in dual combinations with proprietary complementary modulators, enable full CFTR correction in CF models. The data are featured in an oral presentation and poster session at the European Cystic Fibrosis Society (ECFS) 48thEuropean Cystic Fibrosis Conference being held in Milan, Italy. Preclinical data suggest these compounds, when used in combination, have the potential to dramatically improve clinical outcomes and quality of life for people with CF." Sionna has completed Phase 1 clinical trials evaluating two potent first-in-class small molecule NBD1 stabilizers, SION-719 and SION-451. The company is also developing modulators with mechanisms of action that are complementary to NBD1, including SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. In the CFHBE model, SION-719 & SION-451 dual combinations also show potential for clinically meaningful improvement including to wild-type levels at concentrations below Emax. Earlier this week, Sionna announced its plans to advance SION-719 andSION-451 to the next stage of clinical development. The company plans to evaluate SION-719 in a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to standard of care (SOC), and SION-451 in a Phase 1 healthy volunteer trial evaluating SION-451 in two dual combinations with SION-2222 and with SION-109. Both trials are expected to initiate in the second half of 2025, with data anticipated in mid-2026.
공시 • Jun 04Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic FibrosisSionna Therapeutics, Inc. announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers. Sionna plans to advance both NBD1 stabilizers to the next stage of clinical development -- SION-719 to a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to SOC, and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719, and SION-451 in healthy volunteers. SionNA is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add- on to SOC and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers. Positive Phase 1 Results for SION-719 and SION-451: The Phase 1 randomized, double-blind, placebo-controlled clinical trials evaluated the safety, tolerability, and PK profiles of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719 and SION-451 in healthy volunteers. The effect of food on the PK and the bioequivalence of a tablet formulation was also evaluated in Part C of each trial. 100 subjects were dosed in the SION-719 trial and 110 subjects were dosed in the SION-451 trial. Both compounds were generally well tolerated in the Phase 1 trials. There were no serious adverse events, treatment emergent adverse events (TEAEs) that led to discontinuation of drug, or dose-limiting TEAEs observed. Most TEAEs were mild to moderate (Grade 1 or Grade 2). There was one Grade 1 TEAE related to liver function tests (LFTs) in a SION-451 treated subject who tested positive for influenza; no TEAEs related to LFTs were observed in the other cohorts of SION-451. There were no TEAEs related to LFTs in SION-719 treated subjects. The data from Part C of each trial support the use of a tablet formulation in future studies and indicate that both compounds can be dosed in a fed or fasted state. SION-719 and SION-451 each achieved desired target PK concentrations at multiple dose levels in a twice daily regimen. Both stabilizers met exposure thresholds that, based on Sionna’s preclinical CFHBE model, have the potential to provide clinically meaningful benefit if administered as an add-on to SOC or in a proprietary dual combination with complementary modulators. Next Phase of Clinical Development for NBD1 Stabilizers: SION-719 to Advance to Phase 2a Proof-of-concept in CF Patients as an Add-on to Standard of Care: Sionna is progressing SION-719 into a Phase 2a POC trial evaluating the compound as an add-on to SOC in CF patients. The trial objectives will be to show an improvement in CFTR function as defined by sweat chloride reduction and to demonstrate that NBD1 is mechanistically unique from, and synergistic with, the components of SOC. Sionna is on track to initiate this trial in the second half of 2025 with topline data anticipated in mid-2026. The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SION-719, and the first subject has been dosed in a midazolam drug-drug interaction (DDI) study to confirm SION-719 can be dosed in combination with the SOC according to its label. This study will be completed prior to initiation of the Phase 2a trial. SION-451 to Advance to Phase 1 Healthy Volunteer Dual Combination Trial with Complementary Modulators: Sionna plans to initiate a Phase 1 healthy volunteer dual combination trial evaluating SION-451 in combination with SION-2222 (galicaftor), a transmembrane domain 1 (TMD1)-directed CFTR corrector, and with SION-109, an intracellular loop 4 (ICL4)-directed CFTR corrector. The trial will assess the safety, tolerability, and PK of varying doses of the dual combinations, and will inform selection of a dual combination for a Phase 2b trial in CF patients. Sionna is on track to initiate the healthy volunteer trial in the second half of 2025 with topline data expected in mid-2026.
공시 • May 22Sionna Therapeutics to Present Preclinical Data During Oral Session At the 48Th European Cystic Fibrosis ConferenceSionna Therapeutics, Inc. announced that preclinical data assessing combinations of Sionna's nucleotide-binding domain 1 (NBD1) stabilizers, SION-451 and SION-719, with complementary Sionna CFTR modulators, galicaftor (SION-2222) and SION-109, will be featured in an oral presentation at the European Cystic Fibrosis Society's (ECFS) 48thEuropean Cystic Fibrosis Conference, being held June 4-7, 2025 in Milan, Italy.
공시 • Apr 30Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025Sionna Therapeutics, Inc., Annual General Meeting, Jun 12, 2025.
공시 • Feb 07Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million.Sionna Therapeutics, Inc. has completed an IPO in the amount of $190.588194 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,588,233 Price\Range: $18 Transaction Features: Sponsor Backed Offering