Aankondiging • Aug 06
Vigil Neuroscience, Inc.(NasdaqGS:VIGL) dropped from NASDAQ Composite Index Vigil Neuroscience, Inc. has been removed from NASDAQ Composite Index . New Risk • Aug 06
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$59m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$59m free cash flow). Share price has been highly volatile over the past 3 months (69% average weekly change). Earnings are forecast to decline by an average of 5.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$133m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Aankondiging • Jun 04
Vigil Neuroscience, Inc. Provides Update on Iluzanebart Phase 2 Ignite Trial in ALSP Vigil Neuroscience, Inc. announced an update on the Phase 2 IGNITE open-label clinical trial evaluating iluzanebart, a monoclonal antibody TREM2 agonist, for the potential treatment of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). Iluzanebart demonstrated a favorable safety, tolerability and pharmacokinetic profile across both the 20 mg/kg and 40 mg/kg dose cohorts. The Phase 2 IGNITE trial showed no beneficial effects on biomarker or clinical efficacy endpoints with treatment of iluzanebart in ALSP patients. About the Phase 2 IGNITE Clinical Trial and ILLUMINATE Natural History Study: IGNITE was a global Phase 2, open-label proof-of-concept trial designed to evaluate iluzanebart in 20 patients with symptomatic ALSP who have a confirmed CSF1R gene mutation. The primary objective of the IGNITE trial was to evaluate the safety and tolerability of iluzanebart. Secondary outcome measures included the evaluation the effects of iluzanebart on target engagement and on MRI and NfL biomarkers of disease progression. These symptoms typically exhibit rapid progression with a life expectations of approximately six to seven years on average after diagnosis, causing significant patient and caregivers burden. There are currently no approved therapies for the treatment of ALSP, underscoring the high unmet need in this rare indication. Price Target Changed • May 22
Price target decreased by 19% to US$13.10 Down from US$16.19, the current price target is an average from 7 analysts. New target price is 66% above last closing price of US$7.88. The company is forecast to post a net loss per share of US$1.83 next year compared to a net loss per share of US$2.07 last year. Aankondiging • May 22
Sanofi (ENXTPA:SAN) entered into a definitive merger agreement to acquire Vigil Neuroscience, Inc. (NasdaqGS:VIGL) for approximately $380 million. Sanofi (ENXTPA:SAN) entered into a definitive merger agreement to acquire Vigil Neuroscience, Inc. (NasdaqGS:VIGL) for approximately $380 million on May 21, 2025. Sanofi will acquire all outstanding common shares of Vigil for $8.00 per share in cash at closing, representing an equity value of approximately $470 million (on a fully diluted basis). In addition, Vigil’s shareholders will receive a non-transferrable CVR per Vigil share, which will entitle its holder to receive a deferred cash payment of $2.00, conditioned upon the first commercial sale for VG-3927, represents approximately $600 million on a fully diluted basis. Iluzanebart (VGL101), Vigil’s monoclonal antibody program, is not being acquired by Sanofi, and its return to Amgen, the original licensor, and the termination of the exclusive license agreement with Amgen solely with respect to VGL101, will occur prior to the closing of the transaction. The acquisition will not have an impact on Sanofi’s financial guidance for 2025.
The closing of the acquisition is subject to other conditions customary for such a transaction, including the approval of holders of a majority of the outstanding shares of Vigil common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Bruce Booth, Atlas Ventures, and Ivana Magovcevic-Liebisch have signed voting and support agreements in favor of the deal. The shares subject to these agreements represent a total of approximately 16% of Vigil’s total common shares outstanding. Sanofi and Vigil expect the transaction to close in the third quarter of 2025.
Centerview Partners LLC is acting as exclusive financial advisor to Vigil, and Goodwin Procter LLP is serving as legal counsel. Aankondiging • Apr 02
Vigil Neuroscience, Inc. Presents Data on its Small Molecule TREM2 Agonist Vv-3927 in Two Oral Presentations at AD/PD™? 2025 International Conference Vigil Neuroscience, Inc. presented data highlighting its oral small molecule program, including its lead clinical candidate VG-3927, in two oral presentations at the AD/PD™? 2025 International Conference on Alzheimer's and Parkinson's Diseases being held April 1 - April 5 in Vienna, Austria. Collectively, VG-3927's favorable safety, tolerability, PK and PD profile support the advancement of this program as a differentiated next-generation therapeutic candidate that may go beyond what is possible with amyloid-based therapies to also target other, unaddressed contributors of disease progression in AD. Key highlights from this presentation demonstrated: VG-3927 is an orally bioavailable small molecule TREM2 agonist that has high specificity for membrane-bound TREM2 versus soluble TREM2 (sTREM2), which leads to increased access to the therapeutic site of action. Collectively across preclinical and clinical data, these key differentiators create a compelling profile for VG-3927 as an investigational next-generation therapy for the treatment of AD. Aankondiging • Apr 01
Vigil Neuroscience, Inc., Annual General Meeting, May 22, 2025 Vigil Neuroscience, Inc., Annual General Meeting, May 22, 2025. Board Change • Mar 18
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Donna Wilcock was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Mar 17
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 30% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$89m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$94.3m market cap). Price Target Changed • Mar 07
Price target increased by 11% to US$17.71 Up from US$16.00, the current price target is an average from 8 analysts. New target price is 608% above last closing price of US$2.50. Stock is down 23% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$2.13 last year. Aankondiging • Jan 23
Vigil Neuroscience, Inc. Reports Positive Data from its Phase 1 Clinical Trial Evaluating Vv-3927 for the Potential Treatment of Alzheimer's Disease Vigil Neuroscience, Inc. announced positive data from its completed Phase 1 clinical trial evaluating VG-3927 for the potential treatment of AD. Collectively, the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile supports the advancement of VG-3927 into a Phase 2 clinical trial as a potential once-daily oral therapy for AD. As the first and only Phase 2-ready oral, once-daily small molecule TREM2 agonist, VG-3927 is designed to provide a differentiated profile that can go beyond targeting amyloid plaques to address additional contributors of disease progression and has the potential to offer a more convenient treatment regimen for those struggling with the immense burden of this disease. Eighty-nine (89) participants received VG-3927, including 34 who were 55 years of age and older. Key takeaways from the Phase 1 clinical trial of VG-3927 include the following: Demonstrated a favorable safety and tolerability profile across all cohorts, including the elderly cohort. All related adverse events were mild or moderate in severity and self-resolving without drug discontinuations. Collectively across preclinical and clinical data, these key differentiators create a compelling profile for VG-3927 as an investigational next-generation therapy for the treatment of AD. New Risk • Nov 27
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$89.8m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$92m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (US$89.8m market cap). Price Target Changed • Nov 08
Price target increased by 9.8% to US$17.57 Up from US$16.00, the current price target is an average from 7 analysts. New target price is 392% above last closing price of US$3.57. Stock is down 35% over the past year. The company is forecast to post a net loss per share of US$2.12 next year compared to a net loss per share of US$2.13 last year. Recent Insider Transactions Derivative • Sep 22
General Counsel & Corporate Secretary notifies of intention to sell stock Christopher Verni intends to sell 40k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of September. If the sale is conducted around the recent share price of US$3.63, it would amount to US$145k. Christopher currently holds less than 1% of total shares outstanding. There has only been one transaction (US$15k purchase) from insiders over the last 12 months. Aankondiging • Sep 17
Vigil Neuroscience, Inc. Announces U.S. Food and Drug Administration Removal the Partial Clinical Hold on its Ongoing Phase 1 Clinical Trial of VG-3927 Vigil Neuroscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial of VG-3927. The FDA's decision was based on a complete response submitted by the Company. While the partial clinical hold did not delay clinical development of VG-3927, the option to increase the exposure limit provides the best opportunity to explore the full pharmacology of VG-3927 as a potentially novel, next generation therapy for those living with Alzheimer's disease. In July 2024, the Company reported interim data from the ongoing Phase 1 single- and multiple-ascending dose clinical trial evaluating VG-3927 in healthy volunteers. These data showed that the safety and tolerability profile observed in individual doses in six SAD and two MAD cohorts supported continued clinical development ofVG-3927. VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1) after repeat dosing. As part of the Phase 1 clinical trial, the Company has initiated dosing of a cohort of Alzheimer's disease patients, including some participants who carry TREM2 or other disease-related variants to explore the biomarker response of VG-3927 after a single dose. Vigil expects to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD. The Company plans to report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025. New Risk • Aug 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$70m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$70m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$102m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Aankondiging • Jul 24
Vigil Neuroscience, Inc. Announces Interim Data from Its Ongoing Phase 1 Clinical Trial Evaluating Vv-3927 in Healthy Volunteers Supporting Continued Development in Alzheimer's Disease Vigil Neuroscience, Inc. announced interim data from its ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers. Collectively, the interim safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile supports continued clinical development of VG-3927 as a potential once-daily oral therapy for AD. Additionally, these data showed that VG-3927 demonstrated functional and durable target engagement. The ongoing trial is a Phase 1 single and multiple ascending dose trial to assess the safety, tolerability, PK and PD of VG-3927. As of June 30, 2024, the trial had enrolled 80 healthy volunteers, of which 60 have received VG-3927 across multiple SAD and MAD cohorts. Key takeaways from the interim data include the following: Safety and tolerability profile observed in individual doses in six SAD and two MAD cohorts in the ongoing Phase 1 clinical trial supports continued clinical development of VG-3927. All adverse events (AEs) were mild or moderate in severity, and all AEs resolved without intervention. No serious adverse events have been reported to date. VG-3927 demonstrated a predictable PK profile that is supportive of once-daily dosing. In the SAD and MAD cohorts, VG-3927 achieved a robust and sustained decrease of sTREM2 in the CSF. VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1), a biomarker associated with neuroprotective microglia, after repeat dosing. An effect on soluble Colony Stimulating Factor 1 Receptor (sCSF1R), a microglial trophic factor, has not been observed to date. As part of the Phase 1 clinical trial, the Company has commenced screening for a cohort of AD patients, including some participants who carry TREM2 or other disease-related variants to explore the biomarker response of VG-3927 after a single dose. The Company plans to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD. Vigil plans to report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025. The Company also announced that it plans to present new preclinical data from its small molecule program, including in vivo AD-related functional data, and clinical data from the VG-3927 SAD cohorts in the Phase 1 clinical trial, in an oral presentation at the upcoming 2024 Alzheimer’s Association International Conference (AAIC) taking place on July 28 – August 1, 2024 in Philadelphia, Pennsylvania and virtually. Aankondiging • Jul 18
Vigil Neuroscience, Inc. Provides Update on Clinical Development Strategy to Pursue Potential Accelerated Approval Pathway for Iluzanebart in ALSP Vigil Neuroscience, Inc. announced an update following a Type C Meeting with the U.S. Food and Drug Administration (FDA) to its clinical development strategy for its IGNITE clinical trial evaluating iluzanebart in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The Company plans to report the final analysis from the IGNITE clinical trial, including all patients at 12 months dosed with either 20 mg/kg or 40 mg/kg of iluzanebart in the first half of 2025. IGNITE is a global Phase 2 clinical trial to evaluate iluzanebart as a treatment for symptomatic ALSP patients who have a confirmed CSF1R gene mutation. Patients enrolled in the trial receive an intravenous (IV) infusion of iluzanebart at 20 mg/kg or 40 mg/kg approximately every four weeks for a treatment duration of one year. The trial is evaluating safety, biomarker endpoints, including magnetic resonance imaging (MRI) and neurofilament light chain (NfL), and clinical endpoints using standard cognitive, motor and functional assessments. Aankondiging • Jun 28
Vigil Neuroscience, Inc. announced that it expects to receive $39.99997 million in funding from Sanofi Pasteur Biologics, LLC, Aventis Inc. Vigil Neuroscience, Inc. announced a private placement of 537,634 Series A non-voting convertible preferred shares at a price of $7.44 per share for the gross proceeds of $39,999,970 on June 27, 2024. The transaction will include participation from new investor, Sanofi Pasteur Biologics, LLC and Aventis Inc. Each share shall be convertible into ten shares of common stock. The transaction is expected to close on July 1, 2024. New Risk • Jun 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$103m net loss in 3 years). Shareholders have been diluted in the past year (5.3% increase in shares outstanding). Market cap is less than US$100m (US$94.3m market cap). New Risk • May 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 11% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$127m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (5.3% increase in shares outstanding). Price Target Changed • May 09
Price target increased by 8.4% to US$18.57 Up from US$17.13, the current price target is an average from 7 analysts. New target price is 465% above last closing price of US$3.29. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$2.13 next year compared to a net loss per share of US$2.13 last year. New Risk • Apr 24
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$125m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (5.5% increase in shares outstanding). Market cap is less than US$100m (US$99.6m market cap). Aankondiging • Apr 23
Vigil Neuroscience, Inc., Annual General Meeting, Jun 05, 2024 Vigil Neuroscience, Inc., Annual General Meeting, Jun 05, 2024, at 08:30 US Eastern Standard Time. Agenda: To discuss elect three class III directors to board of directors, to serve until the 2027 annual meeting of stockholders and until successor has been duly elected and qualified, or until earlier death, resignation or removal; to ratify the appointment of PricewaterhouseCoopers LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve an amendment to Third Amended and Restated Certificate of Incorporation to limit the liability of certain of officers as permitted by Delaware law; and to transact any other business properly brought before the Annual Meeting or any adjournment or postponement of the Annual Meeting. Aankondiging • Apr 18
Vigil Neuroscience, Inc. Presents Key Findings from Illuminate & Ignite Studies in ALSP At the 2024 American Academy of Neurology Annual Meeting Vigil Neuroscience, Inc. announced the presentation of multiple oral and poster presentations on the Company's lead clinical candidate iluzanebart at the 2024 American Academy of Neurology (AAN) Annual Meeting. The disease generally presents in adults in their forties, is diagnosed through genetic testing and established clinical/radiologic criteria and is characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment. These symptoms typically exhibit rapid progression with a life expectations of approximately six to seven years on average after diagnosis, causing significant patient and caregivers burden. There are currently no approved therapies for the treatment of ALSP, underscoring the high unmet need in this rare indication. Interim analysis of the Phase 2 IGNITE proof-of-concept, multicenter, open-label study evaluating safety, tolerability, and clinical effects of iluzanebart demonstrated: A favorable safety and tolerability profile; Predictable pharmacokinetic (PK) profile that is supportive of once-monthly dosing; CNS target engagement and downstream pharmacological activity, including increased cerebrospinal fluid (CSF) levels of soluble colony-stimulating factor-1 receptor (sCSF1R), which is emerging as a key biomarker of ALSP disease pathophysiology; Positive trends consistent with slowing of disease progression on key magnetic resonance imaging (MRI) measures in individual patients; Encouraging trend emerging on changes in NfL reduction in individual patients. New Risk • Mar 27
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.5% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$151m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (3.5% increase in shares outstanding). Price Target Changed • Mar 27
Price target increased by 10% to US$18.86 Up from US$17.13, the current price target is an average from 7 analysts. New target price is 489% above last closing price of US$3.20. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$2.17 next year compared to a net loss per share of US$2.13 last year. New Risk • Mar 26
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.4% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$108m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Aankondiging • Mar 20
Vigil Neuroscience, Inc. Announces Executive Changes Vigil Neuroscience, Inc. announced the appointment of Petra Kaufmann, M.D., M.S., F.A.A.N, as Chief Medical Officer. Dr. Kaufmann succeeds Christopher J. Silber, M.D. Dr. Kaufmann is an accomplished biotech executive joining Vigil Neuroscience from Affinia Therapeutics where she served as Chief Medical Officer leading medical, clinical, patient advocacy and regulatory strategy. Prior to Affinia Therapeutics, Dr. Kaufmann held the position of Senior Vice President, Clinical Development, Translational Medicine & Analytics at Novartis Gene Therapies where she led the company’s global clinical development strategy including global approvals of Zolgensma®. She has also served as Vice President, Translational Medicine at AveXis (acquired by Novartis), and Head, Office of Rare Diseases Research at the National Institutes of Health. Dr. Kaufmann holds an M.S. in biostatistics from Columbia University and an M.D. from the University of Bonn. New Risk • Mar 15
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.0m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$102m net loss in 3 years). Market cap is less than US$100m (US$99.0m market cap). New Risk • Feb 01
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$97.6m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$102m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Market cap is less than US$100m (US$97.6m market cap). Price Target Changed • Jan 28
Price target decreased by 14% to US$17.13 Down from US$19.88, the current price target is an average from 8 analysts. New target price is 475% above last closing price of US$2.98. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$2.11 next year compared to a net loss per share of US$2.16 last year. Aankondiging • Nov 18
Vigil Neuroscience, Inc. Reports Positive Interim Data from Phase 2 Ignite Proof-Of-Concept Clinical Trial Evaluating Iluzanebart (VGL101) as a Treatment for ALSP and from Ongoing Natural History Study ILLUMINATE Vigil Neuroscience, Inc. announced positive interim data from the Company's Phase 2 IGNITE proof-of-concept clinical trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The interim data, representing the first six patients following six months of treatment with 20 mg/kg of iluzanebart (formerly referred to as VGL101), further support the favorable safety and tolerability profile as was previously seen in healthy volunteers. The Company also reported findings from its ongoing natural history study, ILLUMINATE, which continued to provide critical insights on MRI and NfL biomarkers and supports soluble colony stimulating factor 1 receptor (sCSF1R) as a potential key biomarker of ALSP disease pathology. Key Updates from Natural History Study ILLUMINATE: sCSF1R and NfL levels are remarkably altered in ALSP, supporting hypothesis that these are key biomarkers of disease pathology. About Phase 2 IGNITE Clinical Trial: IGNITE is a global Phase 2, open-label proof-of-concept trial evaluating iluzanebart in approximately 15 patients with symptomatic ALSP who have a confirmed CSF1R gene mutation. New Risk • Nov 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$101m net loss in 3 years). Aankondiging • Oct 18
Vigil Neuroscience, Inc. Announces First Participant Dosed in Phase 1 Clinical Trial in Healthy Volunteers Evaluating Vv-3927, a Small Molecule Trem2 Agonist, for Potential Treatment of Alzheimer's Disease Vigil Neuroscience, Inc. announced that the Company has dosed its first participant in a Phase 1 clinical trial in healthy volunteers evaluating VG-3927, the first and only small molecule TREM2 agonist in the clinic for the potential treatment of Alzheimer's disease (AD). The double-blind, placebo-controlled Phase 1 clinical trial plans to evaluate VG-3927 in SAD (single) and MAD (multiple) ascending dose cohorts in healthy volunteers. The study is designed to evaluate VG-3927's safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). The Company anticipates reporting interim Phase 1 topline data in mid-2024. Vigil's highly active, selective, and brain-penetrant small molecule TREM2 agonists, VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands. In preclinical studies, Vigil has established that VG-3927 demonstrated on-target TREM2 activation across both common and rare TREM2 variants. Additionally, VG-3927 demonstrated preclinically that it was able to deliver in vivo TREM2 responses within the central nervous system at a magnitude and specificity similar to VGL101. Aankondiging • Oct 13
Vigil Neuroscience, Inc Provides an Update on the Small Molecule TREM2 Agonist, VG-3927 On October 12, 2023, Vigil Neuroscience, Inc. provided an update on the Company’s small molecule TREM2 agonist, VG-3927. The Company announced that it received the 30-day response letter (“Letter”) from the U.S. Food and Drug Administration (“FDA”) regarding the previously communicated partial clinical hold on its Investigational New Drug application for VG-3927. The Letter states that additional non-clinical data will need to be provided in order to exceed the maximum exposure limit in the Phase 1 trial evaluating VG-3927 in healthy volunteers. The Company is in the process of obtaining additional pharmacokinetic data and will work with the FDA to address the partial clinical hold. The Company stated that the Letter otherwise does not alter its prior statements concerning its small molecule TREM2 agonist program. The disclosure under this Item 8.01 contains “forward-looking statements” of the Company that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding the Company’s ability to work with the FDA to address the partial clinical hold. Factors that could cause actual results to differ include the risks inherent in working with the FDA and the Company’s ability to provide additional pharmacokinetic data to the FDA; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and in any subsequent filings it may make with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. All disclosure under this Item 8.01 is as of the date of this Form 8-K, and the Company undertakes no duty to update this information unless required by law. Aankondiging • Sep 28
Vigil Neuroscience, Inc. Receives Positive Opinion from European Medicines Agency on Orphan Drug Designation for Vgl101 for the Treatment of ALSP Vigil Neuroscience, Inc. announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Company's application for orphan drug designation for VGL101 for the treatment of CSF1R-related leukoencephalopathy, which includes adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The Company is currently evaluating VGL101 in a Phase 2 proof-of-concept trial in patients with ALSP. VGL101 was previously granted orphan drug designation by the U.S. Food and Drug Administration for ALSP in July 2022. The EMA may grant orphan drug designation based on a positive opinion issued by the COMP. The EMA's orphan drug designation is available to sponsors developing therapies that aim to treat or prevent rare, life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU, and for which no treatment is approved. Medicines that meet the EMA's orphan drug designation criteria qualify for certain benefits, such as reduced regulatory fees, protocol assistance, research grants, and, subject to obtaining and maintaining orphan medicine status, up to ten years of market exclusivity in the EU upon approval. About the Phase 2 IGNITE Trial The Company's ongoing Phase 2 IGNITE trial is a global, open-label clinical trial evaluating VGL101 in approximately 15 patients with symptomatic ALSP who have a confirmed CSF1R gene mutation. As part of the protocol, patients will receive an intravenous (IV) infusion of VGL101 at 20 mg/kg or 40 mg/kg approximately every four weeks, for a treatment duration of one year. The primary objective of the IGNITE trial is to evaluate the safety and tolerability of VGL101. Secondary objectives include evaluating the impact of VGL101 on magnetic resonance imaging (MRI) and its pharmacodynamics effect on fluid biomarkers in patients with symptomatic ALSP. Clinical efficacy outcome measures are also being collected as exploratory endpoints. In the fourth quarter of 2023, the Company expects to report interim 6-month data from the IGNITE trial in the first 6 patients who have received 20 mg/kg of VGL101. Aankondiging • Sep 12
Vigil Neuroscience, Inc. Presents VGL101 Complete Phase 1 Data and Phase 2 Ignite Trial Design at the 2023 American Neurological Association Annual Meeting Vigil Neuroscience, Inc. announced the complete data analysis from its VGL101 Phase 1 single and multiple ascending dose (SAD and MAD) healthy volunteer trial in a poster presentation at the 2023 American Neurological Association (ANA) Annual Meeting. In addition, the Company presented a poster highlighting the study design for its ongoing IGNITE Phase 2 clinical trial. The Phase 1 SAD and MAD trial was designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VGL101 in healthy volunteers. The trial enrolled 136 healthy volunteers who received either VGL101 (n=113) at fixed single doses ranging from 1 to 60 mg/kg or three ascending doses ranging from 20 to 60 mg/kg, or placebo (n=23). An interim safety analysis of VGL101 for the 1 mg/kg to 40 mg/kg SAD cohorts and data for the 20 mg/kg MAD cohort were previously disclosed in November 2022. Highlights from the VGL101 Phase 1 healthy volunteer trial presented at the ANA Annual Meeting include: VGL101 demonstrated a favorable safety and tolerability profile in SAD and MAD cohorts at doses up to 60 mg/kg. VGL101 showed linear and predictable pharmacokinetic characteristics and an observed half-life that supports monthly dosing. The Phase 1 cerebrospinal fluid (CSF) biomarker data demonstrated pharmacologic activity across multiple measures: Demonstrated proof-of-target engagement based on dose-dependent, robust and durable reductions in soluble TREM2 (sTREM2) following repeat dosing. Increased soluble CSF1R (sCSF1R) and osteopontin levels were durable following repeat dosing indicating that VGL101 impacted microglial activity downstream of TREM2 target engagement. Target engagement and downstream pharmacodynamic responses of VGL101 at 20 mg/kg and 40 mg/kg support evaluating these doses in the ongoing IGNITE Phase 2 trial in ALSP patients. In a separate poster at the ANA Annual Meeting, the Company presented the trial design for its ongoing Phase 2 IGNITE trial. IGNITE is a global, open-label clinical trial evaluating VGL101 in approximately 15 patients with symptomatic ALSP who have a confirmed CSF1R gene mutation. As part of the protocol, patients will receive an intravenous (IV) infusion of VGL101 at 20 mg/kg or 40 mg/kg approximately every four weeks, for a treatment duration of one year. The primary objective of the IGNITE trial is to evaluate the safety and tolerability of VGL101. Secondary objectives include evaluating the impact of VGL101 on magnetic resonance imaging (MRI) and its pharmacodynamic effect on fluid biomarkers in patients with symptomatic ALSP. Clinical efficacy outcome measures are also being collected as exploratory endpoints. In the fourth quarter of 2023, the Company expects to report interim 6-month data from the IGNITE trial in the first 6 patients who have received 20 mg/kg of VGL101. VGL101, Vigil’s lead product candidate, is a fully human monoclonal antibody targeting human triggering receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. TREM2 deficiency is believed to be a driver of certain neurodegenerative diseases. VGL101 is in development for rare microgliopathies, such as ALSP, as well as other neurodegenerative diseases for which TREM2 and/or microglia deficiency is believed to be a key driver of disease pathway. New Risk • Aug 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$106m net loss in 3 years). Aankondiging • Aug 09
Vigil Neuroscience, Inc. Appoints Christopher J. Silber, M.D. as Chief Medical Officer Vigil Neuroscience, Inc. announced the appointment of Christopher J. Silber, M.D. as Chief Medical Officer. Dr. Silber brings over 30 years of biopharmaceutical industry experience and a track record of clinical and regulatory success developing novel therapeutics in neuroscience. Dr. Silber joins Vigil from Nocion Therapeutics, where he was Chief Medical Officer and led the clinical strategy for the company's small molecule platform, including development of NTX-1175, a new chemical entity for cough indications. Prior to Nocion, he served as Senior Vice President, Clinical Development at Sage Therapeutics, where he led clinical development efforts for the portfolio, supporting the U.S. Food and Drug Administration (FDA) approval of ZULRESSO for the treatment of postpartum depression, zuranolone development for major depressive disorder and postpartum depression, and progression of the early neurology therapeutics pipeline. Previously at Agilis Biotherapeutics, Dr. Silber served as Chief Medical Officer where he oversaw the gene therapy pipeline focused on rare diseases of the CNS, including work contributing to the subsequent approval of Upstaza for aromatic L-amino acid decarboxylase (AADC) deficiency. He also held positions of increasing responsibilities at Lundbeck, Takeda, Hospira and Abbott Laboratories. Dr. Silber earned his B.A. in Psychology from Tufts University and his M.D. at Jacobs School of Medicine and Biomedical Sciences at the University of Buffalo. Aankondiging • Feb 12
Vigil Neuroscience, Inc. Announces Resignation of Shaan Gandhi, from Member of Board of Directors On February 8, 2023, Shaan Gandhi, MD, PhD, MBA, notified Vigil Neuroscience, Inc. (“ Vigil”) of his resignation as a member of Vigil’s board of directors (the “ Board”), effective as of February 10, 2023, where he serves as a Class I director and member of the Audit and Compensation Committees. Dr. Gandhi’s resignation is because he has accepted employment with a third party, the terms of which do not permit service as a board member of any company. Dr. Gandhi’s resignation did not result from any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices. The Company thanks Dr. Gandhi for his substantial contributions as a founding Board member and wishes him well in his future endeavors. Board Change • Dec 31
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. Chairman of the Board Bruce Booth is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Recent Insider Transactions Derivative • Nov 25
Chief Medical Officer notifies of intention to sell stock Spyridon Papapetropoulos intends to sell 13k shares in the next 90 days after lodging an Intent To Sell Form on the 18th of November. If the sale is conducted around the recent share price of US$13.86, it would amount to US$185k. Since March 2022, Spyridon's direct individual holding has increased from 20.00 shares to 4.00k. Company insiders have collectively bought US$86k more than they sold, via options and on-market transactions, in the last 12 months. Aankondiging • Nov 03
Vigil Neuroscience Announces Interim Topline Results from its Ongoing Phase 1 Clinical Trial Evaluating VGL101 in Healthy Volunteers Supporting Phase 2 Initiation in ALSP Vigil Neuroscience, Inc. announced interim topline results from its ongoing Phase 1 clinical trial of VGL101, its lead product candidate, in healthy volunteers. These interim data support the initiation of a Phase 2 proof-of-concept trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) with a 20 mg/kg dose. This ongoing trial is a Phase 1 single and multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VGL101. As of October 7, 2022, the trial had enrolled 82 healthy volunteers who received either VGL101 (n=68) at doses of 1, 3, 10, 20, 30 or 40 mg/kg or placebo (n=14). VGL101 was found to be safe and well-tolerated across both the SAD and MAD cohorts dosed. Interim topline results from the ongoing Phase 1 trial of VGL101 include the following: All adverse events (AEs) were mild in severity with the exception of one moderate AE of dizziness, and all AEs resolved without intervention. No serious adverse events have been reported to date. VGL101 showed dose proportional PK with a favorable half-life and brain penetration. VGL101 achieved dose dependent, durable decreases in levels of sTREM2 in the cerebrospinal fluid (CSF) demonstrating proof of target engagement. VGL101 20 mg/kg repeat dosing was associated with robust reduction in sTREM2 levels and decreases were still observed 28 days after the third and final dose. VGL101 is the first antibody reported to demonstrate durability of TREM2 engagement in a clinical setting. VGL101 shows durable increases in sCSF1R levels in the CSF after repeat dosing. The Company continues to dose escalate in its Phase 1 trial in healthy volunteers and has been cleared to initiate a 60 mg/kg cohort in Australia. The Company expects to provide the final data analysis at a future medical conference. Vigil is on track to initiate the VGL101 Phase 2 trial in ALSP patients with a 20 mg/kg dose this quarter. Aankondiging • Nov 02
Vigil Neuroscience Receives FDA Fast Track Designation for VGL101 for the Treatment of Patients with ALSP Vigil Neuroscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VGL101 for the treatment of patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). VGL101, Vigil’s lead product candidate, is a monoclonal antibody TREM2 agonist currently being evaluated in a Phase 1 trial in healthy volunteers. Fast Track designation is designed to facilitate development and expedite the review of therapies for serious conditions, such as ALSP, and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communications with the FDA as well as the potential for priority review and a rolling submission of the marketing application. About VGL101: VGL101, Vigil’s lead product candidate, is a fully human monoclonal antibody targeting human triggering receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. TREM2 deficiency is believed to be a driver of certain neurodegenerative diseases. VGL101 is in development for the treatment of rare microgliopathies, such as ALSP, as well as other neurodegenerative diseases for which TREM2 and/or microglia deficiency is believed to be a key driver of disease pathway. Aankondiging • Aug 30
Vigil Neuroscience, Inc. announced that it has received $74.999705 million in funding from Deep Track Capital, LP, BVF Partners L.P., Deerfield Management Company, L.P. Series C, Dafna Capital Management, LLC, The Invus Group, LLC On August 29, 2022, Vigil Neuroscience, Inc. closed the transaction. The transaction included participation from 9 investors pursuant to Regulation D. Aankondiging • Aug 13
Vigil Neuroscience, Inc. announced that it expects to receive $74.999705 million in funding from Deep Track Capital, LP, BVF Partners L.P., Deerfield Management Company, L.P. Series C, Dafna Capital Management, LLC, The Invus Group, LLC Vigil Neuroscience, Inc. has entered into a securities purchase agreement with certain existing and new accredited investors for gross proceeds of $75,000,000 on August 12, 2022. The transaction included participation from lead returning investor Deep Track Capital, LP, new investors BVF Partners L.P., an investment fund affiliated with Deerfield Management Company, L.P. Series C, returning investors Dafna Capital Management, LLC, The Invus Group, LLC. The company will issue 7,293,084 shares at a price of $7.30 per share for gross proceeds of $53,239,513.2; and pre-funded warrants to purchase up to an aggregate of 2,980,889 shares at a purchase price of $7.2999 per pre-funded warrant. The pre-funded warrants will have an exercise price of $0.0001 per shares, be immediately exercisable and remain exercisable until exercised in full. The transaction is expected to close on August 16, 2022, subject to customary closing conditions. Aankondiging • Jul 29
Vigil Neuroscience Appoints Suzanne Bruhn to Its Board of Directors Vigil Neuroscience, Inc. announced the appointment of Suzanne Bruhn, Ph.D. to its Board of Directors. Dr. Bruhn has more than 20 years of biopharmaceutical experience and a proven track record in developing and commercializing therapies for the treatment of serious diseases with significant unmet need. She is currently President and Chief Executive Officer of Tiaki Therapeutics. Prior to that, she served as President and Chief Executive Officer at Proclara Biosciences, where she led the clinical-stage company’s evolution into orphan diseases, and served as President and Chief Executive Officer at Promedior, which was acquired by Bristol Myers Squibb. Previously, Dr. Bruhn held multiple leadership roles in global regulatory affairs, strategic planning, and program management at Shire Human Genetic Therapies (formerly Transkaryotic Therapies) and Cytotherapeutics. Dr. Bruhn currently serves on the Board of Directors of Pliant Therapeutics and Travere Therapeutics. She holds a Bachelor of Science with distinction in chemistry from Iowa State University of Science and Technology, a Ph.D. in chemistry from Massachusetts Institute of Technology and was a postdoctoral research fellow in the Department of Genetics at Harvard Medical School. Aankondiging • Jun 08
Vigil Neuroscience, Inc. Expands VGL101 Phase 1 Trial to Australia Vigil Neuroscience, Inc. announced it has received approval from the Australian Human Research Ethics Committee (HREC) to initiate a Phase 1 study of VGL101 in healthy volunteers without dosing restrictions. Under the approved protocol, the Company will evaluate VGL101 at doses above 20 mg/kg allowing for immediate exploration of higher doses with a focus on maintaining optionality for future indications. In regard to the VGL101 Phase 1 trial in the U.S., the Food and Drug Administration (FDA) has suggested that Vigil may wish to consider the feasibility of administration of a 30 mg/kg dose. This progress with the FDA was made in response to Vigil’s most recent submission of data from a 6-month GLP toxicology study in nonhuman primates (in which there were no observed adverse findings) and Phase 1 single ascending dose clinical data that includes patients dosed at 20 mg/kg. The partial clinical hold that limits dosing above 20 mg/kg remains in effect while Vigil continues to work with the FDA to lift the partial clinical hold. Importantly, Vigil remains on track to report VGL101 Phase 1 topline data and initiate the Phase 2 proof-of-concept trial in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) patients in the fourth quarter of 2022. Aankondiging • Apr 21
Vigil Neuroscience, Inc. Appoints Christopher Verni as General Counsel and Mary Thistle to Its Board of Directors Vigil Neuroscience, Inc. announced the appointments of Christopher Verni as General Counsel and Mary Thistle to its Board of Directors. Mr. Verni brings over 20 years of broad legal experience in the biotech and pharma industries. He was most recently Senior Vice President, Deputy General Counsel and Chief Intellectual Property Officer at Sarepta Therapeutics. There he provided legal counsel and contributed to legal risk management during a period of high growth with the commercial launch of three rare disease therapies. Ms. Thistle has more than 25 years of experience leading biopharmaceutical companies’ strategy, business development and finance and has deep expertise in an array of therapeutic areas. She currently serves as Special Advisor at the Bill & Melinda Gates Research Institute. Aankondiging • Jan 09
Vigil Neuroscience, Inc. has completed an IPO in the amount of $98 million. Vigil Neuroscience, Inc. has completed an IPO in the amount of $98 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,000,000
Price\Range: $14
Transaction Features: Reserved Share Offering; Sponsor Backed Offering