Annuncio • Nov 18
Stealth BioTherapeutics Corp(NasdaqGM:MITO) dropped from NASDAQ Composite Index Stealth BioTherapeutics Corp has been removed from NASDAQ Composite Index . Board Change • Nov 16
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 6 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). Independent Director Lou Lange was the last independent director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Annuncio • Nov 02
Stealth BioTherapeutics Corp Announces SBT-272 Data Updates and Orphan Drug Designation for the Treatment of Amyotrophic Lateral Sclerosis Stealth BioTherapeutics Corp. announced encouraging Phase 1 data on the safety and tolerability of SBT-272, a next- generation small molecule designed to reach therapeutic concentrations in the brain and to restore mitochondrial structure and function. The Company also announced that positive preclinical data demonstrating that treatment with SBT-272 provided neuroprotection of upper motor neurons harboring ALS pathology will be presented at the Northeast Amyotrophic Lateral Sclerosis conference in Clearwater, FL. The Company recently received Orphan Drug Designation from the US Food and Drug Administration Office of Orphan Products Development for SBT-272 for the treatment of patients with ALS. Annuncio • Oct 01
Stealth BioTherapeutics Corp Announces Departure of Robert Weiskopf as Chief Financial Officer Stealth BioTherapeutics Corp. announced that Robert Weiskopf, Stealth's chief financial officer, is leaving the company effective September 30, 2022. Mr. Weiskopf joined Stealth in 2019 following the company's initial public offering to spearhead its public financial reporting activities and grow the Company's financial team. Annuncio • Jul 12
Stealth BioTherapeutics Announces Receipt of Non-Compliance Notice from Nasdaq Stealth BioTherapeutics Corp. announced that it received a letter from the Listing Qualifications department of The Nasdaq Stock Market LLC ("Nasdaq") on July 7, 2022 notifying the Company that, based upon the Company's continued non-compliance with the minimum bid price and market value of listed securities requirements, as set in Nasdaq Listing Rules 5450(a)(1) and 5450(b)(2), the Company's securities would be delisted from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the "Panel"). Pursuant to the letter, unless the Company requests an appeal, trading of the Company's American Depositary Shares will be suspended at the opening of business on July 18, 2022, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's securities from listing and registration on The Nasdaq Stock Market. The Company plans to timely request a hearing before the Panel, which request will stay any further action by Nasdaq at least until completion of the hearing process. Annuncio • Jun 15
Stealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth Syndrome Stealth BioTherapeutics Corp. announced its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth Syndrome. The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome. The FDA has granted the meeting request and the Company expects this meeting to occur during the third quarter. Annuncio • Jun 09
Stealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration Symposium Stealth BioTherapeutics Corp. announced the presentation of new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology, which plays a significant role in both amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The data were presented at the Keystone Neurodegeneration Symposium in Keystone, CO held June 5-9, 2022. A Phase 1 study to evaluate the safety and tolerability of SBT-272 in healthy volunteers is underway. SBT-272 significantly improved mitochondrial structural integrity and motility in TDP-43 mutant (A315T)-expressing upper motor neurons. These enhancements in mitochondrial health were associated with improved axon outgrowth, a key indicator of improved neuronal health. The effect of SBT-272 on axon outgrowth was superior to edaravone (approved for the treatment of ALS) and AMX0035 (NDA under FDA review). Chronic in vivo administration of SBT-272 reduced upper motor neuron degeneration and neuroinflammation in the motor cortex of the prp-hTDP-43A315T-UeGFP mouse model of ALS. Together, these data support further investigation of SBT-272 as a potential treatment for ALS with TDP-43 pathology. Annuncio • May 24
Stealth BioTherapeutics Corp Announces Data from the Phase 2 ReCLAIM-2 Study of Elamipretide in Geographic Atrophy at the Clinical Trials at the Summit Meeting 2022 Stealth BioTherapeutics Corp. announced new data from the ReCLAIM-2 study of elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD) at the Clinical Trials at the Summit meeting in Lake Tahoe, Nevada. The ReCLAIM-2 prespecified analyses demonstrate that elamipretide ameliorated progressive decline, or attenuation, of the mitochondrial rich ellipsoid zone (EZ) layer of the photoreceptors (p<0.01) and showed a categorical >2-line improvement in low luminance visual acuity (LLVA) (p=0.04) in patients with GA. Progressive LLVA dysfunction, which is among the first symptoms of dry AMD, compromises patients' ability to see under low-light conditions such as at dusk, in the evening, or indoors using artificial light. Additional analyses show that, consistent with prior findings from the ReCLAIM Phase 1 study, changes in LLVA correlated with baseline EZ attenuation in ReCLAIM-2. The new analyses also show that elamipretide-mediated reduction of progressive EZ attenuation correlated with improvements in LLVA. Although the trial's primary endpoints of mean change in LLVA and GA progression were not met, these analyses were found to be promising and to support and inform the continued development of elamipretide for dry AMD. Dry AMD is a progressive retinal disease in which the photoreceptors, which are specialized neurons found in the retina that convert light into electrical signals required for normal visual function, suffer progressive damage and death, leading to progressive loss of vision. One of the earliest signs of photoreceptor dysfunction is progressive damage to, or attenuation of, the ellipsoid zone (EZ), which is a mitochondrial rich layer of the photoreceptors. EZ attenuation has been shown to precede and predict visual dysfunction in dry AMD and other retinal diseases. Elamipretide was generally well tolerated in ReCLAIM-2. The rate of new-onset exudations was 5.3% in the elamipretide treated group versus 6.9% in placebo. The company is also progressing the clinical development of elamipretide in several rare disease indications as well as advancing a broad pipeline of novel mitochondria-targeting compounds. Annuncio • May 03
Stealth Biotherapeutics Announces Data from Reclaim-2 Phase 2 Trial of Elamipretide in Geographic Atrophy Stealth BioTherapeutics announced top-line data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration. Although the trial did not meet its primary endpoints assessing mean changes in LLVA and GA, a key secondary endpoint showed however that elamipretide categorically improved visual function for patients with GA. Additionally, elamipretide demonstrated proof of mechanism by reducing progressive ellipsoid zone loss, a key biomarker of retinal mitochondrial health which has been shown to be predictive of long-term GA growth and development. Based on these data, the Company currently plans to progress development initiatives intended to better position this indication for potential partnering consistent with previous guidance. ReCLAIM-2 was a randomized, double-masked, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of elamipretide over 48 weeks in 176 patients with GA. Elamipretide improved LLVA relative to placebo, although the mean change (primary endpoint) was not statistically significant. Administration of elamipretide resulted in a 2 or more line gain in LLVA for greater than 15% of patients completing the 48-week trial (p=0.04). Although this improvement in visual function was not associated with reduced GA progression (primary endpoint), a significant reduction in ellipsoid zone loss (p=0.0034) was observed. Elamipretide was generally well tolerated in ReCLAIM-2. Injection site reactions were the most commonly observed adverse events and in some cases led to early termination. The rate of new-onset exudations was 5% for patients treated with elamipretide versus 7% for patients treated with placebo. Board Change • Apr 29
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Lou Lange was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Mar 31
Stealth BioTherapeutics Corp Announces New SBT-272 Data and Trial Initiation Stealth BioTherapeutics Corp. announced the presentation of new SBT-272 preclinical data at the Mitochondrial Biochemistry in Health and Disease Symposium in Breckenridge, CO and dosing of the first subject in its Phase 1 clinical trial of SBT-272. The new data demonstrated behavioral and metabolic improvements with SBT-272 in a mouse model of Huntington's disease. In the study, mice were treated for up to 8 weeks with daily SBT-272 and displayed significantly improved motor function compared to vehicle-treated mice. SBT-272-treated mice also showed improved metabolism in multiple brain regions of the diseased animals, assessed in vivo using PET imaging. The Phase 1 clinical trial is a double-blind, placebo controlled safety study enrolling up to 64 healthy subjects across multiple cohorts. SBT-272 is being administered via subcutaneous injection. As a primary objective, the study will evaluate safety and tolerability of single and multiple ascending doses of SBT-272. Secondary objectives include an analysis of the pharmacokinetic profile of SBT-272 and identification of the appropriate dose range for Phase 2 testing. Annuncio • Feb 16
Last Patient Completes Treatment in Stealth BioTherapeutics' Phase 2 Geographic Atrophy Clinical Trial Stealth BioTherapeutics Corp. announced that the final patient in its 176-subject, ReCLAIM-2 phase 2 clinical trial for extra-foveal geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) has completed treatment. The Company is developing elamipretide for treatment of extra-foveal GA under U.S. FDA Fast Track designation. A deficit in vision under low light conditions, such as at dusk, during nighttime, or with artificial (indoor) lighting, is often the first clinical symptom of dry AMD, in which irreversible and progressive death of retinal pigment endothelial cells (GA progression) can eventually lead to blindness. Elamipretide previously demonstrated improvement from baseline in assessments of low-light visual function and a lower-than-expected rate of GA progression (relative to the natural history) after 24-weeks of elamipretide therapy in ReCLAIM, a Phase 1 clinical trial that enrolled 40 subjects with dry AMD. ReCLAIM-2 is designed to assess the safety and efficacy of elamipretide compared to placebo after 48-weeks of administration in 176 subjects with extra-foveal GA. ReCLAIM-2 will assess changes in low-luminance best-corrected visual acuity (LLVA) and in GA area measured by optical coherence tomography (OCT) as the primary endpoint family. Secondary and exploratory endpoints include changes in low-luminance reading acuity, best-corrected visual acuity (BCVA) and patient reported outcomes, GA progression measured by fundus autofluorescence, attenuation of the ellipsoid zone, which is the mitochondria-rich layer of the retina, and assessment of disease progression in the non-study eye. Full enrollment was completed in February 2021 and the last patient completed the 48-week treatment period in February 2022. The subject database remains blinded with the current emphasis on confirmation of all data entered at study sites, as well as completion of source data verification in preparation of database lock. Topline results are anticipated during the second quarter of 2022, with full analysis to follow. Annuncio • Feb 13
Stealth BioTherapeutics Receives Nasdaq Notification Regarding Minimum Market Value of Publicly Held Shares Requirement Stealth BioTherapeutics Corp. announced that on February 11, 2022, it received a letter from The Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it is currently not in compliance with the minimum Market Value of Publicly Held Shares (MVPHS) requirement based upon Nasdaq's review of the Company's MVPHS for the 30 consecutive business days through February 10, 2022. This press release is issued pursuant to Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of deficiency notifications. The notifications have no immediate effect on the listing of the Company's ADSs, which will continue to trade uninterrupted on Nasdaq under the ticker "MITO". Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the Company has a compliance period of 180 calendar days, or until August 10, 2022 (the "Compliance Period"), to regain compliance with Nasdaq's minimum bid price requirement. If at any time during the Compliance Period, the Company's MVPHS closes at $15,000,000 or more for a minimum of 10 consecutive business days, Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed. Annuncio • Jan 09
Stealth BioTherapetuics Receives Nasdaq Notifications Regarding Minimum Bid and Market Value Requirements Stealth BioTherapeutics Corp. announced that on January 4, 2022, it received a letter from The Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it is currently not in compliance with the minimum bid pricerequirement set under Nasdaq Listing Rule 5450(a)(1). It resulted from the fact that the closing bid price of the Company's American Depositary Shares ("ADSs") was below $1.00 per share for a period of 30 consecutive business days. The Company also announced that on January 5, 2022 it received a letter from Nasdaq notifying the Company that it is currently not in compliance with the minimum market value of listed securities ("MVLS") requirement set under Nasdaq Listing Rule 5450(b)(2)(A). It resulted from the fact that the market value of the Company's ADSs was below $50,000,000 for a period of 30 consecutive business days. Annuncio • Dec 15
Stealth Bio Therapeutics Provides Update on Clinical Stage Rare Disease Programs Stealth BioTherapeutics Corp. reported an update on its clinical-stage rare disease programs. Duchenne muscular dystrophy (DMD). Early data from a study of elamipretide and an exon-skipping phosphorodiamidate morpholino oligomer (PMO), a therapeutic class that has already garnered regulatory approval and commercialization, in the X-linked muscular dystrophy (mdx) mouse model, demonstrated that elamipretide in combination with the PMO significantly increased dystrophin expression in muscle to almost twice the levels observed following stand-alone treatment with the PMO. This may be due to improved mitochondrial bioenergetics augmenting the retainment/efficacy of the PMO. Additional studies are ongoing, and the Company hopes to present the data from these studies at a scientific conference next year. The Company is scheduled to meet with DCN to discuss its development plan for DMD later this month. Barth syndrome. During a constructive Type A meeting to discuss next steps in the Barth syndrome development program, DCN signaled alignment with various design elements of a proposed new clinical trial. At DCN's recommendation, the Company will submit a Request for Advice on the protocol synopsis and expects written feedback from the Division within 45 days. DCN also expressed its willingness to consider other means of generating data supportive of potential approval under alternate pathways, which may require additional animal studies. The Company expects additional interactions with the Division early next year to explore the feasibility of DCN's suggestion. nPMM. The Company remains on track to initiate NuPOWER, its Phase 3 clinical trial enrolling patients with pathogenic nuclear DNA mutations leading to mitochondrial myopathy (nPMM) with site initiation currently underway. This trial is enriched for the subgroup of patients who responded to elamipretide therapy in prior clinical trials. Annuncio • Sep 24
Stealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at International Parkinson and Movement Disorder Society Virtual Congress 2021 Stealth BioTherapeutics Corp. announced the presentation of new promising data from a study evaluating the effects of SBT-272 in a murine model of Parkinson's disease (PD). SBT-272 is a novel, clinical-stage mitochondria-targeted product candidate which is known to cross the blood-brain barrier. The data were presented at the International Parkinson and Movement Disorder Society Virtual Congress 2021. In the study, mice were injected with viral particles that over-express human A53T alpha-synuclein, a mutated protein found in PD, in the substantia nigra, which is an area of the brain that plays a critical role in modulating motor movement. Following the injection, the mice displayed PD pathology, including a significant loss of dopaminergic neurons, which are responsible for relaying messages that control voluntary body movement. In addition, the animals displayed aggregation of alpha-synuclein and markers of neuroinflammation. Systemic daily administration of SBT-272 at two different doses significantly protected against the loss of dopaminergic neurons and the aggregation of pathological alpha-synuclein. In addition, the higher dose of SBT-272 significantly reduced two different markers of neuroinflammation. Overall, the data demonstrate that SBT-272 has a neuroprotective effect in this model of PD. The neuroprotection activity observed in the PD model was supported by an additional collaborative study between Stealth BioTherapeutics and investigators from the Latvian Institute for Organic Synthesis. In this study, systemic SBT-272 treatment protected brain mitochondria against damage caused by ischemic stroke. Taken together, these data highlight the potential of SBT-272 as a systemically administered therapy for treating neurodegenerative diseases. Annuncio • May 06
Stealth Biotherapeutics Corp Showcases Data for Elamipretide in Dry Age-Related Macular Degeneration At the 2021 Arvo Annual Meeting Stealth BioTherapeutics Corp. announced the presentation of new data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy (GA) and high risk drusen associated with dry age-related macular degeneration (AMD). The data, presented at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, showed that for patients with GA treated with elamipretide for 24-weeks, improvements from baseline in low light visual acuity (LLVA), which is the primary efficacy endpoint in Stealth's fully enrolled Phase 2 ReCLAIM-2 trial, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone (EZ). The EZ is a mitochondria-rich area of the retina which supports photoreceptor function and is attenuated in dry AMD. EZ imaging assessments were conducted using optical coherence tomography (OCT) and included pan-macular EZ-retinal pigment endothelium cell (RPE) volume and macular percentage of EZ-RPE attenuation. Improvements in LLVA were significantly correlated to both baseline EZ-RPE volume and EZ-RPE attenuation, with eyes gaining two or more lines showing significantly less EZ-RPE attenuation and percentage area of macular GA at baseline. Annuncio • Mar 17
Stealth BioTherapeutics Corp Announces Promotion of Marty Redmon to Chief Research & Development Officer Stealth BioTherapeutics announced promotion of Marty Redmon, Ph.D., Executive Vice President, Discovery, Development, and Tech Ops, to the role of Chief Research & Development Officer, effective immediately. Following his promotion to Chief Research & Development Officer, Dr. Redmon will continue to be responsible for the oversight of all disciplines involved in the Company's pharmaceutical sciences and technical operations to support preclinical, clinical, and commercial supply needs, as well as its discovery platform comprising over 100 novel mitochondrial targeted pipeline compounds. Marty has more than 25 years of experience in pharmaceutical R&D, operations, and project and functional line management. Prior to joining Stealth in 2015, he served as Senior Vice President of Research, Development and Technical Operations at Precision Dermatology, and has previously held pharmaceutical development positions at Eli Lilly, Focal, Sepracor, Praecis, and ArQule. Annuncio • Feb 24
Stealth BioTherapeutics Corp Completes Enrollment of Phase 2 Study in Dry Age-Related Macular Degeneration with Geographic Atrophy Stealth BioTherapeutics Corp. announced that the company completed enrollment for ReCLAIM-2 (SPIAM-202), and expects top-line data in the first half of 2022. ReCLAIM-2 is a phase 2 randomized, double-masked, placebo-controlled study to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA). The ReCLAIM-2 study completed enrollment with 176 patients. The primary endpoint of the 48-week study will measure the low-luminance best-corrected visual acuity, which assesses visual function under low light conditions meant to represent dusk or indoor (artificial) lighting. Secondary functional endpoints are change in low-luminance reading acuity, best-corrected visual acuity (BCVA). Secondary imaging endpoints assessing the rate of progression of the disease include GA area as measured by fundus autofluorescence and optical coherence tomography. In November 2018, the U.S. Food and Drug Administration granted Fast Track designation for elamipretide for patients with dry AMD with GA. Is New 90 Day High Low • Feb 10
New 90-day high: €1.53 The company is up 39% from its price of €1.10 on 12 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 11% over the same period. Is New 90 Day High Low • Jan 19
New 90-day high: €1.39 The company is up 16% from its price of €1.20 on 21 October 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 4.0% over the same period. Annuncio • Jan 06
Stealth BioTherapeutics Granted Pre-NDA Meeting For Elamipretide As Treatment For Cardiomyopathy In Barth Syndrome Stealth BioTherapeutics Corp. announced its plan to meet with the FDA's Division of Cardiology and Nephrology (DCN) regarding its upcoming NDA submission for elamipretide for the treatment of cardiomyopathy in Barth syndrome. This Type B Pre-NDA meeting follows prior interactions in 2019 with the Division of Neurology Products (DNP) and in 2019 and 2020 with the Division of Rare Disease and Medical Genetics (DRDMG) during which the Agency encouraged the Company to generate additional clinical data to support its Barth NDA submission, including by implementing a withdrawal protocol for the patients remaining on open-label extension. More recently, the Company met with DCN to discuss an NDA submission for the treatment of cardiomyopathy in Barth syndrome, which included a discussion of cardiac-focused protocol designs. During this meeting, DCN suggested that, based on the short half-life of elamipretide, a short-term withdrawal period could be sufficient to measure durable effect on functional or structural cardiac endpoints by demonstrating that improvement is not dependent on continuous exposure to the drug. Although DCN reiterated the prior feedback from DRDMG regarding the insufficiency of the current data package for NDA submission, the Company believes that the existing data with additional analyses could meet the requirements for an NDA. The company is proposing that a short-term withdrawal protocol for open-label extension participants be conducted in parallel with NDA review and that a larger Phase 3b/4 withdrawal study in treatment-nave patients be completed as a post-marketing confirmatory study. The company plans to discuss this and other aspects of the anticipated NDA submission during the Pre-NDA meeting next month. Is New 90 Day High Low • Dec 29
New 90-day high: €1.27 The company is up 15% from its price of €1.10 on 30 September 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Dec 10
Stealth BioTherapeutics Corp Announces Board and Committee Changes On December 3, 2020, Lu Huang resigned as a member of the Board of Directors (the ‘Board’) of Stealth BioTherapeutics Corp. (the ‘Company’), effective immediately. Dr. Huang’s decision to resign from the Board was not due to a disagreement on any matter related to the Company’s operations, policies or practices. On December 4, 2020, the Board, acting in accordance with the recommendation of the Nominating Committee of the Board, appointed Dr. Eve Slater as a Class I director and as a member of the Remuneration Committee, effective as of December 4, 2020. Dr. Slater is currently Professor of Clinical Medicine at Columbia Vagelos College of Physicians and Surgeons (P&S), where she has taught for over 35 years. She was Senior Vice President, Worldwide Policy, Pfizer Inc. form May 2007 to June 2009. Prior to that, she served as Assistant Secretary for Health in the U.S. Department of Health and Human Services from 2001 to 2003, and spent over 19 years with Merck and Co., where she was Executive Director of Biochemistry and Molecular Biology, Vice President and Senior Vice President of Clinical and Regulatory Development, and SVP of External Policy. Is New 90 Day High Low • Dec 05
New 90-day low: €1.02 The company is down 18% from its price of €1.24 on 04 September 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Analyst Estimate Surprise Post Earnings • Nov 20
Revenue in line with expectations Revenue was in line with analyst estimates. Over the next year, revenue is forecast to stay flat compared to a 197% growth forecast for the Biotechs industry in Germany. Is New 90 Day High Low • Nov 11
New 90-day low: €1.03 The company is down 29% from its price of €1.46 on 13 August 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 18% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Analyst Estimate Surprise Post Earnings • Nov 07
Revenue in line with expectations Revenue was in line with analyst estimates. Over the next year, revenue is expected to shrink by 5.7% compared to a 321% growth forecast for the Biotechs industry in Germany. Annuncio • Nov 06
Stealth Biotherapeutics Announces Development Financing to Advance Elamipretide Clinical Trials Stealth BioTherapeutics Corp. announced the first closing under a Development Funding Agreement to support the clinical development of elamipretide. Stealth received $20 million and is expected to receive up to an additional $15 million from Morningside Ventures contingent on near-term clinical milestones associated with Stealth's geographic atrophy and Barth syndrome development programs. Additional investors may participate in subsequent closings of up to an additional $35 million of near-term funding commitments. In addition, the agreement contemplates that Stealth may receive up to an additional $35 million upon meeting certain pre-defined future milestones and subject to the agreement of the parties. Funds are intended to support the continued clinical development of elamipretide. Under the terms of the agreement, Stealth will pay participating investors regulatory approval milestone payments in annual increments on a pre-determined payment schedule over seven years, with the majority of payments due in years 5-7 following regulatory approval. No approval payments are owed should regulatory approval not be achieved for elamipretide in the indications currently under or planned for near-term development. Stealth has an option to buy out all future, unpaid milestone payments at any time following certain regulatory approvals at a discounted rate. Stealth will retain exclusive worldwide commercial rights to elamipretide in all indications. Annuncio • Oct 31
Stealth BioTherapeutics Corp to Report Q3, 2020 Results on Nov 05, 2020 Stealth BioTherapeutics Corp announced that they will report Q3, 2020 results at 9:00 AM, Eastern Standard Time on Nov 05, 2020 Is New 90 Day High Low • Sep 29
New 90-day low: €1.08 The company is down 31% from its price of €1.56 on 01 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Sep 24
Stealth BioTherapeutics Announces Poster Presentation at 2020 Annual NEALS Meeting Stealth BioTherapeutics announced that the company will present an abstract in a poster session at the upcoming 2020 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting, which is being held online from September 30th to October 1st. The selected poster has been awarded the 2020 Annual NEALS Meeting UMN/PLS Poster Award. The poster, entitled "The mitochondrial targeted peptidomimetic SBT-272 protects cortical spinal motor neurons from mutant TDP43 pathology," demonstrates that SBT-272 protects upper motor neurons from mutant TDP43 driven neurodegeneration. TDP43 pathology has been observed in multiple neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Lobar Degeneration (FTLD), Lewy Body Dementia (LBD), Progressive Supranuclear Palsy (PSP), and Alzheimer's Disease, and is believed to play a role in neuronal cell death. The data from this study supports further investigation of SBT-272 for the treatment of these and other neurodegenerative diseases in which TDP43 pathology is thought to contribute to disease burden. SBT-272 is a novel peptidomimetic being developed for the treatment of neurodegenerative diseases involving mitochondrial dysfunction. SBT-272 has been shown to increase adenosine triphosphate (ATP) production and decrease levels of reactive oxygen species (ROS) in dysfunctional mitochondria in preclinical studies. SBT-272 demonstrates higher mitochondrial uptake and greater concentrations in the central nervous system relative to elamipretide, Stealth's first-in-class lead compound. Treatment with SBT-272 was associated with a dose-dependent delay in the onset of neurological disease, a reduction in systemic markers of neurodegeneration and prolonged lifespan in a mouse model of amyotrophic lateral sclerosis (ALS). In addition, SBT-272 treatment was associated with the preservation of dopaminergic neurons in the substantia nigra of a mouse model of mutant alpha-synuclein driven neurodegeneration. Alpha-synucleinopathy is a common pathological feature of several neurodegenerative diseases, including Parkinson's Disease, Multiple Systems Atrophy and Alzheimer's Disease. Further preclinical evaluation of SBT-272 in the context of protein misfolding diseases which lead to mitochondrial dysfunction and subsequent neurodegeneration is on-going. Annuncio • Jul 31
Stealth BioTherapeutics Corp to Report Q2, 2020 Results on Aug 06, 2020 Stealth BioTherapeutics Corp announced that they will report Q2, 2020 results at 9:00 AM, Eastern Standard Time on Aug 06, 2020 
