View ValuationThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsNVN Liquidation 将来の成長Future 基準チェック /06現在、 NVN Liquidationの成長と収益を予測するのに十分なアナリストの調査がありません。主要情報n/a収益成長率n/aEPS成長率Pharmaceuticals 収益成長23.7%収益成長率n/a将来の株主資本利益率n/aアナリストカバレッジNone最終更新日n/a今後の成長に関する最新情報Breakeven Date Change • Feb 24Forecast to breakeven in 2025The 6 analysts covering Novan expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$12.4m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule.すべての更新を表示Recent updatesお知らせ • Sep 29Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) completed the acquisition of Substantially All of the Assets of Novan, Inc.Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) entered into a stalking horse asset purchase agreement to acquire Substantially All of the Assets of Novan, Inc. for $30 million on July 17, 2023. Novan entered into a “stalking horse” asset purchase agreement with Ligand Pharmaceuticals to sell substantially all of the assets of the Company and its subsidiaries, including EPI Health (the “Purchased Assets”) for an upfront payment of $15 million. The cash payable at closing will be reduced dollar-for-dollar by the outstanding balance of the DIP Credit Facility which will be repaid at closing. The Purchase Agreement provides that the Company will pay a break-up fee to Ligand equal to $450,000 upon termination of the transaction in certain circumstances, including the entry into or consummation of an alternative transaction for the Purchased Assets with a party other than Ligand. Ligand Pharmaceuticals provide up to $15 million in DIP financing to Novan inclusive of a $3 million bridge loan already funded. The transaction is part of a sale process under Section 363 of the Bankruptcy Code that will be subject to approval by the Bankruptcy Court and compliance with agreed upon and Bankruptcy Court-approved bidding procedures allowing for the submission of higher or otherwise better offers, and other agreed-upon conditions. The transaction is expected to close in the third quarter of 2023. Gerald F. Roach; Christopher B. Capel; James R. Jolley of Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. and Derek Abbot of Morris, Nichols, Arsht & Tunnell LLP acted as legal advisors for Novan. Craig Wolfe of Morgan, Lewis & Bockius LLP acted as legal advisor for Ligand Pharmaceuticals. Birch Lake is acting as financial advisor for Ligand Pharmaceuticals. Novan engaged Raymond James & Associates, Inc. andSIERRACONSTELLATION PARTNERS LLC. as financial advisor. Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) completed the acquisition of Substantially All of the Assets of Novan, Inc. on September 27, 2023.お知らせ • Sep 08Nasdaq To Delist the Common Stock of NovanNasdaq announced that it will delist the common stock of Novan, Inc. Novan, Inc.’s securities were suspended on July 26, 2023, and have not traded on Nasdaq since that time.お知らせ • Jul 27Novan, Inc.(OTCPK:NOVN.Q) dropped from NASDAQ Composite IndexNovan, Inc. has been dropped from Nasdaq Composite Index.お知らせ • Jul 18+ 3 more updatesNovan's Securities to Be Delisted from NasdaqAs previously disclosed on July 17, 2023, Novan, Inc. (the “Company”) filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. The case will be administered under the caption In re: Novan, Inc. et al, Case No. 23-10937. On July 17, 2023, the Company received written notice (the “Delisting Notice”) from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, in accordance with Nasdaq Listing Rules 5101, 5110(b), and IM-5101-1, the staff of Nasdaq has determined that the Company’s securities will be delisted from Nasdaq. In the Delisting Notice, the staff of Nasdaq referenced the Chapter 11 filing and associated public interest concerns raised by it, concerns regarding the residual equity interest of the existing listed securities holders, and concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq. The Company does not intend to appeal the delisting determination. Trading of the Company’s common stock will be suspended at the opening of business on July 26, 2023 and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the common stock from listing and registration on Nasdaq. As a result, the Company’s common stock is expected to begin trading on the over-the-counter (“OTC”) market on July 26, 2023. On the OTC market, shares of the Company’s common stock, which previously traded on Nasdaq under the symbol NOVN, are expected to trade under the symbol NOVNQ.お知らせ • Jul 07Novan Receives a Deficiency Letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC Regarding MVLS RequirementOn June 30, 2023, Novan, Inc. (the Company") received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (Nasdaq") notifying the Company that it is not in compliance with Listing Rule 5550(b)(2), which requires the Company to maintain a minimum market value of listed securities of at least $35 million (the MVLS Requirement") for continued listing on the Nasdaq Capital Market. The letter noted that, as of that date, the Company's market value of listed securities was below $35 million for at least 30 consecutive business days. In accordance with Nasdaq rules, the Company has been provided 180 calendar days, or until December 27, 2023, to regain compliance with the MVLS Requirement or else be subject to delisting. To regain compliance with the MVLS Requirement, the Company's market value of listed securities must close at $35 million or more for a minimum of ten consecutive business days during the 180 calendar-day compliance period. The notification received has no immediate effect on the Company's continued listing on the Nasdaq Capital Market, subject to the Company's compliance with the other continued listing requirements. The Company continues to manage cash expenditures and cash flows, while pursuing various potential financing and strategic options to, among other things, advance its product candidate for molluscum contagiosum.Reported Earnings • May 17First quarter 2023 earnings released: US$0.54 loss per share (vs US$0.71 loss in 1Q 2022)First quarter 2023 results: US$0.54 loss per share. Revenue: US$3.17m (up 64% from 1Q 2022). Net loss: US$14.1m (loss widened 5.5% from 1Q 2022). Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.お知らせ • May 09Novan, Inc. to Report Q1, 2023 Results on May 15, 2023Novan, Inc. announced that they will report Q1, 2023 results on May 15, 2023Reported Earnings • Mar 31Full year 2022 earnings released: US$1.42 loss per share (vs US$1.74 loss in FY 2021)Full year 2022 results: US$1.42 loss per share. Revenue: US$23.7m (up US$20.7m from FY 2021). Net loss: US$31.3m (loss widened 5.5% from FY 2021). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.Breakeven Date Change • Feb 24Forecast to breakeven in 2025The 6 analysts covering Novan expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$12.4m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule.お知らせ • Jan 07Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (Sb206) for the Treatment of Molluscum ContagiosumNovan, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum ("molluscum"). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval. Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. The active ingredient, berdazimer sodium, is a new chemical entity that releases nitric oxide and has anti-viral activity.(4) If approved, berdazimer gel, 10.3% would be the first effective and safe topical treatment indicated for molluscum with the convenience of self-application. Results from the pivotal Phase 3 B-SIMPLE4 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum (NCT04535531) demonstrated highly statistically significant improvement in primary clinical endpoint (p< 0.0001) in the largest cohort of molluscum patients ever studied and were recently published in JAMA Dermatology. Berdazimer gel, 10.3% was found to be well tolerated with mild application site pain and mild to moderate erythema reported as the most common adverse events.お知らせ • Nov 08Novan, Inc. to Report Q3, 2022 Results on Nov 14, 2022Novan, Inc. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 14, 2022お知らせ • Jul 14Novan Announces Publication of Positive Results from Pivotal Phase 3 Study of Berdazimer Gel, 10.3% (Sb206) in Patients with Molluscum Contagiosum in Jama DermatologyNovan, Inc. announced the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology. Berdazimer gel, 10.3%, Novan's potential first-in-class topical nitric oxide-based prescription treatment, demonstrated favorable efficacy and safety. Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4, was a multicenter, vehicle-controlled, double-blind study, which enrolled 891 patients across 55 clinics in the United States that were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions as compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema. Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of berdazimer gel, 10.3% achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of vehicle patients. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a =90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients. In June 2021, Novan reported a statistically significant greater treatment effect as compared to vehicle for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12. Overall, berdazimer gel, 10.3% was well tolerated with low discontinuation rates due to adverse events. Although treatment-emergent adverse events (TEAS) were numerically higher in those receiving berdazimer gel, 10.3%, the majority were mild in severity. Local skin reactions (LSRs) were absent in >92% of all patients, except for erythema (redness), which was the most frequently observed LSR in berdazimer gel, 10.3% patients and mostly mild to moderate. Study patients did not exhibit keloid or hypertrophic scars following treatment.お知らせ • Jun 14Novan, Inc. has completed a Follow-on Equity Offering in the amount of $14.968192 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $14.968192 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,080,696 Price\Range: $2.851 Discount Per Security: $0.143 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 5,261,311 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 3,180,615 Price\Range: $2.841 Discount Per Security: $0.142 Transaction Features: Registered Direct Offeringお知らせ • Jun 11Novan, Inc. has completed a Follow-on Equity Offering in the amount of $15 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $15 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,080,696 Price\Range: $2.851 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 2,080,696 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 3,180,615 Price\Range: $2.841 Transaction Features: Registered Direct Offeringお知らせ • May 07Novan, Inc. to Report Q1, 2022 Results on May 16, 2022Novan, Inc. announced that they will report Q1, 2022 results on May 16, 2022お知らせ • Feb 16Novan, Inc. to Report Fiscal Year 2021 Results on Feb 22, 2022Novan, Inc. announced that they will report fiscal year 2021 results on Feb 22, 2022お知らせ • Sep 24Novan Reports Safety Data from B-SIMPLE4 Pivotal Phase 3 Study of SB206Novan, Inc. announced the comprehensive safety data readout as part of the Company’s B-SIMPLE4 pivotal Phase 3 study of SB206 for the treatment of molluscum contagiosum (“molluscum”). B-SIMPLE4 was a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12. In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12 in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206. Consistent with results from the Company’s prior Phase 2 and Phase 3 studies, SB206 was also found to be safe and well tolerated in the B-SIMPLE4 study at Week-12. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study. The treatment emergent adverse events (“TEAEs”) profile of SB206 through the Week-24 visit was found to be favorable and consistent with the previous Phase 3 studies, B-SIMPLE1 and B-SIMPLE2. The TEAEs reported in greater than 5% of subjects in the SB206 treated groups were all at the application site (pain, erythema, pruritis, exfoliation, and dermatitis) with the high majority of these TEAEs being mild or moderate by severity. Molluscum, caused by the molluscipoxvirus, is known to occasionally heal with some scarring, or small pitting at the lesion site. Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence. The TEAEs for scarring throughout the study were slightly higher in the vehicle group (6.3%) vs. SB206 (4.7%). Subjects treated with SB206 showed a lower occurrence of scarring at the Week-24 visit when compared to vehicle (4.0% in vehicle vs. 2.7% in SB206). These findings were generally consistent with observations from B-SIMPLE1 and B-SIMPLE2.お知らせ • Jun 18Novan, Inc. has completed a Follow-on Equity Offering in the amount of $40.000004 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $40.000004 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 3,636,364 Price\Range: $11お知らせ • Jun 12Novan, Inc. Reports Positive Topline Results from Pivotal Phase 3 Trial of Sb206 in Patients with Molluscum ContagiosumNovan, Inc. announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (molluscum). Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).お知らせ • Jun 11Novan, Inc. Announces Positive Preclinical Data in SB019 COVID-19 Anti-Viral Therapy ProgramNovan, Inc. announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters. In light of these promising results, the company is exploring opportunities to develop an anti-viral therapy against COVID-19, the disease caused by the SARS-CoV-2 virus, both internally and potentially through strategic partnerships for this program. To further evaluate the potential of its NITRICIL™ platform technology as an intranasal treatment option for COVID-19, the company initiated preclinical in vivo studies evaluating the efficacy of berdazimer sodium to reduce viral burden in infected animals and to deter viral transmission to uninfected animals. The work was conducted at the Institute for Antiviral Research at Utah State University. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs after transmission, significantly limiting severity of disease in this model. The intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed. SARS-CoV-2 infected animals were co-housed with healthy animals to induce infection via animal-to-animal transmission. The effect of a repeat, once daily intranasal treatment regimen with berdazimer sodium at various doses was assessed versus placebo controls. The endpoints included nasal and lung tissue viral count, in addition to body weight changes, an indicator of disease severity. The company observed a dose-dependent, statistically significant reduction (P<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium concentrations as low as 2 mg/mL compared to placebo-treated controls. The effect was observed after co-habitation with infected hamsters who were also treated with berdazimer sodium. The average amount of virus in the lungs was reduced by greater than 4 logs (>99.99%) with more than half of the animals having no detectable virus in lung tissue at all. Catalent, a leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, continues to support Novan’s CMC efforts and development of an intranasal formulation, SB019, for use in the Company’s COVID-19 program. Preclinical tolerability and toxicology studies were conducted at a third-party research organization to inform product development at Catalent. The initial studies support the established safety profile of berdazimer sodium and suggest favorable tolerability when administered intranasally after repeat dosing. Further, preclinical dose-range finding studies are being conducted to inform potential human clinical trial design and dosing regimen. Based on the scientific literature, the company’s previously reported in vitro results and the in vivo results announced, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates. The company plans to submit a request to the FDA to determine an appropriate path to bring a new potential treatment option to patients, as quickly as possible. The company is evaluating its strategy to submit an IND for the purposes of advancing its SB019 product candidate, subject to regulatory guidance, successful completion of IND-enabling toxicology studies and obtaining additional financing or strategic partnering.お知らせ • Jun 08Novan, Inc. Announces Results from Exploratory Studies Further Demonstrate Antimicrobial Effect of NITRICIL™ Platform Technology with NVN4100 in Companion Animal HealthNovan, Inc. announced positive proof-of-concept in vitro results and informative in vivo results with its new chemical entity, NVN4100, explored as a potential product candidate for topical antimicrobial indications in companion animal health. The company initiated exploratory work to evaluate NVN4100 and engaged with animal health experts at Scullion Strategy Group, LLC to oversee the company’s initial animal health studies and to assess technical feasibility and market potential. The in vivo and in vitro studies were conducted by independent third party animal health research organizations. The exploratory studies were conducted to determine the minimum inhibitory concentration and minimum bactericidal concentration of NVN4100 using broth dilution antimicrobial susceptibility testing against a set of clinically relevant microorganisms. Results from the in vitro assay demonstrated that NVN4100 had both inhibitory and bactericidal effects for a variety of pathogens. The tested pathogens include both antimicrobial resistant and antimicrobial susceptible strains of the most prevalent species associated with skin and ear conditions in animal health, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus pseudintermedius, and Staphylococcus schleiferi. Additionally, in collaboration with an independent third party animal health research organization, the company has established a model of canine pyoderma, one of the most common skin conditions of dogs that is often resistant to first-line antimicrobials, to evaluate topically applied NVN4100 in an in vivo setting. The in vivo results suggest that the canine pyoderma model may serve as an appropriate tool to facilitate further development of NVN4100 as an alternative therapy to systemic and topical antimicrobials for treatment of canine superficial pyoderma or other dermatology indications. Based on the results to date and the availability of funding, the company intends to conduct additional studies and formulation work with NVN4100 to build a robust data set and engage with potential collaborators and strategic partners moving forward. The company seeks to publish the full data set from the companion animal health exploratory studies at an upcoming scientific congress and/or in a peer-reviewed publication.お知らせ • May 04Novan, Inc. Announces Final Week-12 Visit for Last Patient in B-Simple4 Pivotal Phase 3 Study of Sb206 for Treatment of MolluscumNovan, Inc. announced the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.お知らせ • Mar 04Novan, Inc. Appoints Steven D. Skolsky to Its BoardOn March 1, 2021, the Board of Directors of Novan, Inc. voted to increase the size of the Board from seven (7) to eight (8) directors and elected Steven D. Skolsky, to the Board to fill the resulting vacancy, effective immediately, and to serve as a Class I director until the Company’s 2023 Annual Meeting of Stockholders and until his successor is elected and qualified or until his earlier death, resignation or removal. Mr. Skolsky has also been appointed to serve as a member of the Audit Committee of the Board.お知らせ • Feb 25Novan, Inc. Contemplates Bankruptcy Novan, Inc. is contemplating filing for bankruptcy, as of February 24, 2021. According to company SEC filing, Company said that it will need to secure additional capital or financing and/or delay, defer or reduce cash expenditures by the first quarter of 2022. There can be no assurance that the company will be able to obtain additional capital or financing on terms acceptable to the company, on a timely basis or at all. If the company is not able to secure additional financing and is unable to reduce expenditures sufficiently, company may be forced to terminate or eliminate product development programs, wind down operations, liquidate or seek bankruptcy protection.お知らせ • Jan 31Novan Regains Compliance with Nasdaq Minimum Bid Price RequirementNovan, Inc. announced on January 29, 2021 that it has received written notice from The Nasdaq Stock Market LLC (‘Nasdaq’) that the company has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The notice indicated that, as a result of the closing bid price of the company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from January 14, 2021 through January 28, 2021, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2).お知らせ • Jan 20Novan Updates Enrollment for Its B-SIMPLE4 Pivotal Phase 3 Study Evaluating SB206Novan, Inc. provided an update that enrollment for its B-SIMPLE4 pivotal Phase 3 study evaluating SB206, a topical antiviral gel for the treatment of molluscum contagiosum, has reached 90% of the approximately 850 subjects targeted for enrollment in the study. Patient enrollment in the B-SIMPLE4 pivotal Phase 3 study commenced in September 2020 and is expected to enroll approximately 850 patients (1:1 randomization), across 55 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. To-date the study has enrolled approximately 90% of patients for the study. Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are targeted for the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.お知らせ • Dec 17Novan Exceeds 60% Enrollment in B-Simple4 Pivotal Phase 3 Study of Sb206 for Treatment of MolluscumNovan, Inc. announced it has enrolled 525 patients of the approximately 850 patients expected to enroll in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (molluscum). Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 850 patients (1:1 randomization), across approximately 50 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are assessed as treatment failures). Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are anticipated in the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic. There are currently no FDA-approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.お知らせ • Nov 06Novan Receives Approval from the Listing Qualifications Department of the Nasdaq Stock MarketOn November 3, 2020, Novan, Inc. (the “Company”) received approval from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) to transfer the listing of the Company’s common stock from the Nasdaq Global Market to the Nasdaq Capital Market (the “Approval”). The Company’s common stock will be transferred to the Nasdaq Capital Market effective as of the open of business on November 5, 2020, and will continue to trade under the symbol “NOVN.” The Nasdaq Capital Market operates in substantially the same manner as the Nasdaq Global Market, and listed companies must meet certain financial requirements and comply with Nasdaq’s corporate governance requirements.お知らせ • Oct 15Novan, Inc. Announces Positive in vitro Results Showing the Potential Efficacy of Its NITRICIL™ Platform Technology as an Antiviral Against SARS-CoV-2 the Virus That Causes COVID-19Novan, Inc. announced positive in vitro results showing the potential efficacy of its NITRICIL™ platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability of its NITRICIL™ platform technology as a potential nasal treatment option for COVID-19, the Company initiated in vitro assessments targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted at the Institute for Antiviral Research at Utah State University and these results demonstrate the first instance of an antiviral effect from a nitric oxide-based medicine in a 3-D tissue model that has similar structure to the human airway epithelium. The results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of virus after repeat dosing, once daily. Novan plans to initiate Chemistry, Manufacturing, and Controls (CMC) work with a global leader in providing integrated services, superior delivery technologies and manufacturing solutions to develop an intranasal formulation of berdazimer sodium for use in the Company’s COVID-19 program. Based on the scientific literature and data available to-date with berdazimer sodium and Novan’s product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates.お知らせ • Sep 26+ 1 more updateNovan, Inc. Announces the Appointment of John M. Gay as Chief Financial OfficerNovan, Inc. announced the appointment of John M. Gay to serve as the Company’s Chief Financial Officer. Mr. Gay is an accomplished finance and accounting executive with 20 years of professional experience and a demonstrated track record of strategic financial planning and analysis, accessing capital markets and public company technical and regulatory reporting over the course of his career. Mr. Gay joined Novan in May 2018 and has most recently served as Vice President, Finance and Corporate Controller, in addition to Principal Financial Officer and Corporate Secretary for the Company.お知らせ • Aug 15Novan, Inc. May File for Bankruptcy Novan, Inc. may file for bankruptcy, as of August 14, 2020. The company may file for bankruptcy if it fails to get the required financing.お知らせ • Jul 03Novan, Inc.(NasdaqGM:NOVN) dropped from Russell Microcap Value IndexNovan, Inc.(NasdaqGM:NOVN) dropped from Russell Microcap Value Index このセクションでは通常、投資家が会社の利益創出能力を理解する一助となるよう、プロのアナリストのコンセンサス予想に基づく収益と利益の成長予測を提示する。しかし、NVN Liquidation は十分な過去のデータを提供しておらず、アナリストの予測もないため、過去のデータを外挿したり、アナリストの予測を使用しても、その将来の収益を確実に算出することはできません。 シンプリー・ウォール・ストリートがカバーする企業の97%は過去の財務データを持っているため、これはかなり稀な状況です。 業績と収益の成長予測DB:6LUA - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数3/31/202325-32-39-36N/A12/31/202224-31-35-31N/A9/30/202214-37-36-29N/A6/30/20229-37-33-24N/A3/31/20224-34-24-15N/A12/31/20213-30-34-25N/A9/30/20213-28-30-25N/A6/30/20214-30-31-28N/A3/31/20215-32-33-32N/A12/31/20205-29-32-31N/A9/30/20205-29-31-30N/A6/30/20205-30-33-33N/A3/31/20205-30-26-25N/A12/31/20195-30-20-20N/A9/30/20198-17-15-15N/A6/30/20197-15-14-13N/A3/31/20196-14-22-21N/A12/31/20186-13-30-29N/A9/30/20183-28-34-33N/A6/30/20183-28-33-32N/A3/31/20183-30-37-36N/A12/31/20173-37-32-30N/A9/30/20172-42-43-38N/A6/30/20171-52-46-41N/A3/31/20170-60-50-44N/A12/31/2016N/A-60N/A-49N/A9/30/2016N/A-57N/A-41N/A6/30/2016N/A-45N/A-36N/A3/31/2016N/A-32N/A-27N/A12/31/2015N/A-26N/A-22N/A9/30/2015-3-21N/A-17N/A12/31/20140-13N/A-9N/A12/31/20133-6N/A-7N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: 6LUAの予測収益成長が 貯蓄率 ( 0.5% ) を上回っているかどうかを判断するにはデータが不十分です。収益対市場: 6LUAの収益がGerman市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です高成長収益: 6LUAの収益が今後 3 年間で 大幅に 増加すると予想されるかどうかを判断するにはデータが不十分です。収益対市場: 6LUAの収益がGerman市場よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。高い収益成長: 6LUAの収益が年間20%よりも速く成長すると予測されるかどうかを判断するにはデータが不十分です。一株当たり利益成長率予想将来の株主資本利益率将来のROE: 6LUAの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2023/12/17 01:14終値2023/09/19 00:00収益2023/03/31年間収益2022/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋NVN Liquidation, Inc. これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。8 アナリスト機関Brian Kemp DolliverBrookline Capital MarketsJennifer KimCantor Fitzgerald & Co.Donald EllisCitizens JMP Securities, LLC5 その他のアナリストを表示
Breakeven Date Change • Feb 24Forecast to breakeven in 2025The 6 analysts covering Novan expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$12.4m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule.
お知らせ • Sep 29Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) completed the acquisition of Substantially All of the Assets of Novan, Inc.Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) entered into a stalking horse asset purchase agreement to acquire Substantially All of the Assets of Novan, Inc. for $30 million on July 17, 2023. Novan entered into a “stalking horse” asset purchase agreement with Ligand Pharmaceuticals to sell substantially all of the assets of the Company and its subsidiaries, including EPI Health (the “Purchased Assets”) for an upfront payment of $15 million. The cash payable at closing will be reduced dollar-for-dollar by the outstanding balance of the DIP Credit Facility which will be repaid at closing. The Purchase Agreement provides that the Company will pay a break-up fee to Ligand equal to $450,000 upon termination of the transaction in certain circumstances, including the entry into or consummation of an alternative transaction for the Purchased Assets with a party other than Ligand. Ligand Pharmaceuticals provide up to $15 million in DIP financing to Novan inclusive of a $3 million bridge loan already funded. The transaction is part of a sale process under Section 363 of the Bankruptcy Code that will be subject to approval by the Bankruptcy Court and compliance with agreed upon and Bankruptcy Court-approved bidding procedures allowing for the submission of higher or otherwise better offers, and other agreed-upon conditions. The transaction is expected to close in the third quarter of 2023. Gerald F. Roach; Christopher B. Capel; James R. Jolley of Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. and Derek Abbot of Morris, Nichols, Arsht & Tunnell LLP acted as legal advisors for Novan. Craig Wolfe of Morgan, Lewis & Bockius LLP acted as legal advisor for Ligand Pharmaceuticals. Birch Lake is acting as financial advisor for Ligand Pharmaceuticals. Novan engaged Raymond James & Associates, Inc. andSIERRACONSTELLATION PARTNERS LLC. as financial advisor. Ligand Pharmaceuticals Incorporated (NasdaqGM:LGND) completed the acquisition of Substantially All of the Assets of Novan, Inc. on September 27, 2023.
お知らせ • Sep 08Nasdaq To Delist the Common Stock of NovanNasdaq announced that it will delist the common stock of Novan, Inc. Novan, Inc.’s securities were suspended on July 26, 2023, and have not traded on Nasdaq since that time.
お知らせ • Jul 27Novan, Inc.(OTCPK:NOVN.Q) dropped from NASDAQ Composite IndexNovan, Inc. has been dropped from Nasdaq Composite Index.
お知らせ • Jul 18+ 3 more updatesNovan's Securities to Be Delisted from NasdaqAs previously disclosed on July 17, 2023, Novan, Inc. (the “Company”) filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. The case will be administered under the caption In re: Novan, Inc. et al, Case No. 23-10937. On July 17, 2023, the Company received written notice (the “Delisting Notice”) from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, in accordance with Nasdaq Listing Rules 5101, 5110(b), and IM-5101-1, the staff of Nasdaq has determined that the Company’s securities will be delisted from Nasdaq. In the Delisting Notice, the staff of Nasdaq referenced the Chapter 11 filing and associated public interest concerns raised by it, concerns regarding the residual equity interest of the existing listed securities holders, and concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq. The Company does not intend to appeal the delisting determination. Trading of the Company’s common stock will be suspended at the opening of business on July 26, 2023 and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the common stock from listing and registration on Nasdaq. As a result, the Company’s common stock is expected to begin trading on the over-the-counter (“OTC”) market on July 26, 2023. On the OTC market, shares of the Company’s common stock, which previously traded on Nasdaq under the symbol NOVN, are expected to trade under the symbol NOVNQ.
お知らせ • Jul 07Novan Receives a Deficiency Letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC Regarding MVLS RequirementOn June 30, 2023, Novan, Inc. (the Company") received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (Nasdaq") notifying the Company that it is not in compliance with Listing Rule 5550(b)(2), which requires the Company to maintain a minimum market value of listed securities of at least $35 million (the MVLS Requirement") for continued listing on the Nasdaq Capital Market. The letter noted that, as of that date, the Company's market value of listed securities was below $35 million for at least 30 consecutive business days. In accordance with Nasdaq rules, the Company has been provided 180 calendar days, or until December 27, 2023, to regain compliance with the MVLS Requirement or else be subject to delisting. To regain compliance with the MVLS Requirement, the Company's market value of listed securities must close at $35 million or more for a minimum of ten consecutive business days during the 180 calendar-day compliance period. The notification received has no immediate effect on the Company's continued listing on the Nasdaq Capital Market, subject to the Company's compliance with the other continued listing requirements. The Company continues to manage cash expenditures and cash flows, while pursuing various potential financing and strategic options to, among other things, advance its product candidate for molluscum contagiosum.
Reported Earnings • May 17First quarter 2023 earnings released: US$0.54 loss per share (vs US$0.71 loss in 1Q 2022)First quarter 2023 results: US$0.54 loss per share. Revenue: US$3.17m (up 64% from 1Q 2022). Net loss: US$14.1m (loss widened 5.5% from 1Q 2022). Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.
お知らせ • May 09Novan, Inc. to Report Q1, 2023 Results on May 15, 2023Novan, Inc. announced that they will report Q1, 2023 results on May 15, 2023
Reported Earnings • Mar 31Full year 2022 earnings released: US$1.42 loss per share (vs US$1.74 loss in FY 2021)Full year 2022 results: US$1.42 loss per share. Revenue: US$23.7m (up US$20.7m from FY 2021). Net loss: US$31.3m (loss widened 5.5% from FY 2021). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.
Breakeven Date Change • Feb 24Forecast to breakeven in 2025The 6 analysts covering Novan expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$12.4m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule.
お知らせ • Jan 07Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (Sb206) for the Treatment of Molluscum ContagiosumNovan, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum ("molluscum"). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval. Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. The active ingredient, berdazimer sodium, is a new chemical entity that releases nitric oxide and has anti-viral activity.(4) If approved, berdazimer gel, 10.3% would be the first effective and safe topical treatment indicated for molluscum with the convenience of self-application. Results from the pivotal Phase 3 B-SIMPLE4 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum (NCT04535531) demonstrated highly statistically significant improvement in primary clinical endpoint (p< 0.0001) in the largest cohort of molluscum patients ever studied and were recently published in JAMA Dermatology. Berdazimer gel, 10.3% was found to be well tolerated with mild application site pain and mild to moderate erythema reported as the most common adverse events.
お知らせ • Nov 08Novan, Inc. to Report Q3, 2022 Results on Nov 14, 2022Novan, Inc. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 14, 2022
お知らせ • Jul 14Novan Announces Publication of Positive Results from Pivotal Phase 3 Study of Berdazimer Gel, 10.3% (Sb206) in Patients with Molluscum Contagiosum in Jama DermatologyNovan, Inc. announced the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology. Berdazimer gel, 10.3%, Novan's potential first-in-class topical nitric oxide-based prescription treatment, demonstrated favorable efficacy and safety. Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4, was a multicenter, vehicle-controlled, double-blind study, which enrolled 891 patients across 55 clinics in the United States that were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions as compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema. Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of berdazimer gel, 10.3% achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of vehicle patients. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a =90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients. In June 2021, Novan reported a statistically significant greater treatment effect as compared to vehicle for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12. Overall, berdazimer gel, 10.3% was well tolerated with low discontinuation rates due to adverse events. Although treatment-emergent adverse events (TEAS) were numerically higher in those receiving berdazimer gel, 10.3%, the majority were mild in severity. Local skin reactions (LSRs) were absent in >92% of all patients, except for erythema (redness), which was the most frequently observed LSR in berdazimer gel, 10.3% patients and mostly mild to moderate. Study patients did not exhibit keloid or hypertrophic scars following treatment.
お知らせ • Jun 14Novan, Inc. has completed a Follow-on Equity Offering in the amount of $14.968192 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $14.968192 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,080,696 Price\Range: $2.851 Discount Per Security: $0.143 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 5,261,311 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 3,180,615 Price\Range: $2.841 Discount Per Security: $0.142 Transaction Features: Registered Direct Offering
お知らせ • Jun 11Novan, Inc. has completed a Follow-on Equity Offering in the amount of $15 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $15 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,080,696 Price\Range: $2.851 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 2,080,696 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 3,180,615 Price\Range: $2.841 Transaction Features: Registered Direct Offering
お知らせ • May 07Novan, Inc. to Report Q1, 2022 Results on May 16, 2022Novan, Inc. announced that they will report Q1, 2022 results on May 16, 2022
お知らせ • Feb 16Novan, Inc. to Report Fiscal Year 2021 Results on Feb 22, 2022Novan, Inc. announced that they will report fiscal year 2021 results on Feb 22, 2022
お知らせ • Sep 24Novan Reports Safety Data from B-SIMPLE4 Pivotal Phase 3 Study of SB206Novan, Inc. announced the comprehensive safety data readout as part of the Company’s B-SIMPLE4 pivotal Phase 3 study of SB206 for the treatment of molluscum contagiosum (“molluscum”). B-SIMPLE4 was a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12. In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12 in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206. Consistent with results from the Company’s prior Phase 2 and Phase 3 studies, SB206 was also found to be safe and well tolerated in the B-SIMPLE4 study at Week-12. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study. The treatment emergent adverse events (“TEAEs”) profile of SB206 through the Week-24 visit was found to be favorable and consistent with the previous Phase 3 studies, B-SIMPLE1 and B-SIMPLE2. The TEAEs reported in greater than 5% of subjects in the SB206 treated groups were all at the application site (pain, erythema, pruritis, exfoliation, and dermatitis) with the high majority of these TEAEs being mild or moderate by severity. Molluscum, caused by the molluscipoxvirus, is known to occasionally heal with some scarring, or small pitting at the lesion site. Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence. The TEAEs for scarring throughout the study were slightly higher in the vehicle group (6.3%) vs. SB206 (4.7%). Subjects treated with SB206 showed a lower occurrence of scarring at the Week-24 visit when compared to vehicle (4.0% in vehicle vs. 2.7% in SB206). These findings were generally consistent with observations from B-SIMPLE1 and B-SIMPLE2.
お知らせ • Jun 18Novan, Inc. has completed a Follow-on Equity Offering in the amount of $40.000004 million.Novan, Inc. has completed a Follow-on Equity Offering in the amount of $40.000004 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 3,636,364 Price\Range: $11
お知らせ • Jun 12Novan, Inc. Reports Positive Topline Results from Pivotal Phase 3 Trial of Sb206 in Patients with Molluscum ContagiosumNovan, Inc. announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (molluscum). Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).
お知らせ • Jun 11Novan, Inc. Announces Positive Preclinical Data in SB019 COVID-19 Anti-Viral Therapy ProgramNovan, Inc. announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters. In light of these promising results, the company is exploring opportunities to develop an anti-viral therapy against COVID-19, the disease caused by the SARS-CoV-2 virus, both internally and potentially through strategic partnerships for this program. To further evaluate the potential of its NITRICIL™ platform technology as an intranasal treatment option for COVID-19, the company initiated preclinical in vivo studies evaluating the efficacy of berdazimer sodium to reduce viral burden in infected animals and to deter viral transmission to uninfected animals. The work was conducted at the Institute for Antiviral Research at Utah State University. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs after transmission, significantly limiting severity of disease in this model. The intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed. SARS-CoV-2 infected animals were co-housed with healthy animals to induce infection via animal-to-animal transmission. The effect of a repeat, once daily intranasal treatment regimen with berdazimer sodium at various doses was assessed versus placebo controls. The endpoints included nasal and lung tissue viral count, in addition to body weight changes, an indicator of disease severity. The company observed a dose-dependent, statistically significant reduction (P<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium concentrations as low as 2 mg/mL compared to placebo-treated controls. The effect was observed after co-habitation with infected hamsters who were also treated with berdazimer sodium. The average amount of virus in the lungs was reduced by greater than 4 logs (>99.99%) with more than half of the animals having no detectable virus in lung tissue at all. Catalent, a leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, continues to support Novan’s CMC efforts and development of an intranasal formulation, SB019, for use in the Company’s COVID-19 program. Preclinical tolerability and toxicology studies were conducted at a third-party research organization to inform product development at Catalent. The initial studies support the established safety profile of berdazimer sodium and suggest favorable tolerability when administered intranasally after repeat dosing. Further, preclinical dose-range finding studies are being conducted to inform potential human clinical trial design and dosing regimen. Based on the scientific literature, the company’s previously reported in vitro results and the in vivo results announced, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates. The company plans to submit a request to the FDA to determine an appropriate path to bring a new potential treatment option to patients, as quickly as possible. The company is evaluating its strategy to submit an IND for the purposes of advancing its SB019 product candidate, subject to regulatory guidance, successful completion of IND-enabling toxicology studies and obtaining additional financing or strategic partnering.
お知らせ • Jun 08Novan, Inc. Announces Results from Exploratory Studies Further Demonstrate Antimicrobial Effect of NITRICIL™ Platform Technology with NVN4100 in Companion Animal HealthNovan, Inc. announced positive proof-of-concept in vitro results and informative in vivo results with its new chemical entity, NVN4100, explored as a potential product candidate for topical antimicrobial indications in companion animal health. The company initiated exploratory work to evaluate NVN4100 and engaged with animal health experts at Scullion Strategy Group, LLC to oversee the company’s initial animal health studies and to assess technical feasibility and market potential. The in vivo and in vitro studies were conducted by independent third party animal health research organizations. The exploratory studies were conducted to determine the minimum inhibitory concentration and minimum bactericidal concentration of NVN4100 using broth dilution antimicrobial susceptibility testing against a set of clinically relevant microorganisms. Results from the in vitro assay demonstrated that NVN4100 had both inhibitory and bactericidal effects for a variety of pathogens. The tested pathogens include both antimicrobial resistant and antimicrobial susceptible strains of the most prevalent species associated with skin and ear conditions in animal health, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus pseudintermedius, and Staphylococcus schleiferi. Additionally, in collaboration with an independent third party animal health research organization, the company has established a model of canine pyoderma, one of the most common skin conditions of dogs that is often resistant to first-line antimicrobials, to evaluate topically applied NVN4100 in an in vivo setting. The in vivo results suggest that the canine pyoderma model may serve as an appropriate tool to facilitate further development of NVN4100 as an alternative therapy to systemic and topical antimicrobials for treatment of canine superficial pyoderma or other dermatology indications. Based on the results to date and the availability of funding, the company intends to conduct additional studies and formulation work with NVN4100 to build a robust data set and engage with potential collaborators and strategic partners moving forward. The company seeks to publish the full data set from the companion animal health exploratory studies at an upcoming scientific congress and/or in a peer-reviewed publication.
お知らせ • May 04Novan, Inc. Announces Final Week-12 Visit for Last Patient in B-Simple4 Pivotal Phase 3 Study of Sb206 for Treatment of MolluscumNovan, Inc. announced the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.
お知らせ • Mar 04Novan, Inc. Appoints Steven D. Skolsky to Its BoardOn March 1, 2021, the Board of Directors of Novan, Inc. voted to increase the size of the Board from seven (7) to eight (8) directors and elected Steven D. Skolsky, to the Board to fill the resulting vacancy, effective immediately, and to serve as a Class I director until the Company’s 2023 Annual Meeting of Stockholders and until his successor is elected and qualified or until his earlier death, resignation or removal. Mr. Skolsky has also been appointed to serve as a member of the Audit Committee of the Board.
お知らせ • Feb 25Novan, Inc. Contemplates Bankruptcy Novan, Inc. is contemplating filing for bankruptcy, as of February 24, 2021. According to company SEC filing, Company said that it will need to secure additional capital or financing and/or delay, defer or reduce cash expenditures by the first quarter of 2022. There can be no assurance that the company will be able to obtain additional capital or financing on terms acceptable to the company, on a timely basis or at all. If the company is not able to secure additional financing and is unable to reduce expenditures sufficiently, company may be forced to terminate or eliminate product development programs, wind down operations, liquidate or seek bankruptcy protection.
お知らせ • Jan 31Novan Regains Compliance with Nasdaq Minimum Bid Price RequirementNovan, Inc. announced on January 29, 2021 that it has received written notice from The Nasdaq Stock Market LLC (‘Nasdaq’) that the company has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The notice indicated that, as a result of the closing bid price of the company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from January 14, 2021 through January 28, 2021, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2).
お知らせ • Jan 20Novan Updates Enrollment for Its B-SIMPLE4 Pivotal Phase 3 Study Evaluating SB206Novan, Inc. provided an update that enrollment for its B-SIMPLE4 pivotal Phase 3 study evaluating SB206, a topical antiviral gel for the treatment of molluscum contagiosum, has reached 90% of the approximately 850 subjects targeted for enrollment in the study. Patient enrollment in the B-SIMPLE4 pivotal Phase 3 study commenced in September 2020 and is expected to enroll approximately 850 patients (1:1 randomization), across 55 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. To-date the study has enrolled approximately 90% of patients for the study. Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are targeted for the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.
お知らせ • Dec 17Novan Exceeds 60% Enrollment in B-Simple4 Pivotal Phase 3 Study of Sb206 for Treatment of MolluscumNovan, Inc. announced it has enrolled 525 patients of the approximately 850 patients expected to enroll in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (molluscum). Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 850 patients (1:1 randomization), across approximately 50 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are assessed as treatment failures). Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are anticipated in the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic. There are currently no FDA-approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.
お知らせ • Nov 06Novan Receives Approval from the Listing Qualifications Department of the Nasdaq Stock MarketOn November 3, 2020, Novan, Inc. (the “Company”) received approval from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) to transfer the listing of the Company’s common stock from the Nasdaq Global Market to the Nasdaq Capital Market (the “Approval”). The Company’s common stock will be transferred to the Nasdaq Capital Market effective as of the open of business on November 5, 2020, and will continue to trade under the symbol “NOVN.” The Nasdaq Capital Market operates in substantially the same manner as the Nasdaq Global Market, and listed companies must meet certain financial requirements and comply with Nasdaq’s corporate governance requirements.
お知らせ • Oct 15Novan, Inc. Announces Positive in vitro Results Showing the Potential Efficacy of Its NITRICIL™ Platform Technology as an Antiviral Against SARS-CoV-2 the Virus That Causes COVID-19Novan, Inc. announced positive in vitro results showing the potential efficacy of its NITRICIL™ platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability of its NITRICIL™ platform technology as a potential nasal treatment option for COVID-19, the Company initiated in vitro assessments targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted at the Institute for Antiviral Research at Utah State University and these results demonstrate the first instance of an antiviral effect from a nitric oxide-based medicine in a 3-D tissue model that has similar structure to the human airway epithelium. The results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of virus after repeat dosing, once daily. Novan plans to initiate Chemistry, Manufacturing, and Controls (CMC) work with a global leader in providing integrated services, superior delivery technologies and manufacturing solutions to develop an intranasal formulation of berdazimer sodium for use in the Company’s COVID-19 program. Based on the scientific literature and data available to-date with berdazimer sodium and Novan’s product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates.
お知らせ • Sep 26+ 1 more updateNovan, Inc. Announces the Appointment of John M. Gay as Chief Financial OfficerNovan, Inc. announced the appointment of John M. Gay to serve as the Company’s Chief Financial Officer. Mr. Gay is an accomplished finance and accounting executive with 20 years of professional experience and a demonstrated track record of strategic financial planning and analysis, accessing capital markets and public company technical and regulatory reporting over the course of his career. Mr. Gay joined Novan in May 2018 and has most recently served as Vice President, Finance and Corporate Controller, in addition to Principal Financial Officer and Corporate Secretary for the Company.
お知らせ • Aug 15Novan, Inc. May File for Bankruptcy Novan, Inc. may file for bankruptcy, as of August 14, 2020. The company may file for bankruptcy if it fails to get the required financing.
お知らせ • Jul 03Novan, Inc.(NasdaqGM:NOVN) dropped from Russell Microcap Value IndexNovan, Inc.(NasdaqGM:NOVN) dropped from Russell Microcap Value Index