Aclaris Therapeutics (ACRS) - Marktkap: $43 M - Reboundplay (Seite 18)
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ISIN: US00461U1051 · WKN: A1412H · Symbol: 8AT
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Letzter Kurs 20.05.24 Tradegate
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07.05.24 · globenewswire  |
30.04.24 · globenewswire |
27.02.24 · globenewswire |
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Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,7019 | +71,15 | |
| 0,8000 | +45,45 | |
| 2,0600 | +24,85 | |
| 1,1600 | +16,00 | |
| 29,31 | +11,91 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 3,1000 | -12,92 | |
| 61,98 | -13,38 | |
| 23,700 | -19,52 | |
| 3,83 | -40,16 | |
| 1,1600 | -55,89 |
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Antwort auf Beitrag Nr.: 65.022.417 von bigniz am 08.09.20 18:04:57Naja,weiß nicht, bei € 0,80 im März hätte man zuschlagen sollen.... 😉
Richtig, das sind jetzt schon wieder fast Einstiegs- oder Zukaufkurse!
Zumindest für mich...
LG bigniz
Zumindest für mich...
LG bigniz
Das wäre eine perfekte Aktie zum Zocken (gewesen), sobald ich dann verkaufe, läuft mir der Kurs davon, wäre nicht das 1. Mal... 😉😎
Jeden Tag das selbe Bild. Soll hier ordentlich geschüttelt werden?
Tagsüber geht’s runter um wieder auf punktlandung zu schließen.... 🤷🏼♂️
Tagsüber geht’s runter um wieder auf punktlandung zu schließen.... 🤷🏼♂️
Antwort auf Beitrag Nr.: 64.781.290 von goldlutscher am 17.08.20 08:06:07So sieht es aus... ich war mir bei dem Investment nicht ganz sicher, aber wenn man sich den Hype um Pharma im Bezug auf Covid-19 anschaut, kann man sich beruhigt zurücklehnen. Ich bin da ganz bei dir. Minimum ist der Sprung über 4$.
Trading Spotlight
Gan, von der Kansas Universität forschte mit ATI-450 und fand heraus, dass es eventuell gegen KREBS helfen kann.
Doch dann fiel es ihm wie Schuppen von den Augen. ATI-450 hat aus seiner Sicht gute Chancen im Einsatz bei COVID-19!
Sie sind dann auf Aclaris zugegangen und wollten einen Forschungsantrag stellen.
Das hört sich für mich super an!
Doch dann fiel es ihm wie Schuppen von den Augen. ATI-450 hat aus seiner Sicht gute Chancen im Einsatz bei COVID-19!
Sie sind dann auf Aclaris zugegangen und wollten einen Forschungsantrag stellen.
Das hört sich für mich super an!
Mega interessanter Artikel zu ATI-450 von der Kansas Univerity 👌
Ich denke diese Woche, spätestens nächste Woche sehen wir hier nen enormen Sprung nach oben.
http://www.kumc.edu/news-listing-page/gan-polineni.html
Ich denke diese Woche, spätestens nächste Woche sehen wir hier nen enormen Sprung nach oben.
http://www.kumc.edu/news-listing-page/gan-polineni.html
Finde ich auch, man hat mehrere interessante Produkte in der Pipeline und sucht für bereits genehmigte Produkte einen Abnehmer/Vertriebspartner. Die Finanzierung ist bis 2022 gesichert.
Antwort auf Beitrag Nr.: 64.684.270 von walle1fc am 07.08.20 14:59:33Vielen Dank für die Info. Hört sich doch ganz gut an.
Aclaris Therapeutics Reports Second Quarter 2020 Financial Results and Provides R&D and Business Highlights
●
First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
●
First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
●
Clinical Trial of ATI-1777, an Investigational “Soft” Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis
WAYNE, Pa., August 7, 2020 (GLOBE NEWSWIRE) – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and business highlights.
“As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times,” said Dr. Neal Walker, President and CEO of Aclaris. “In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans.”
R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.
● ATI-450, an investigational oral small molecule MK2 inhibitor compound:
o ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
◾ This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
o ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
o IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
◾ The first subject was dosed in August 2020.
● ATI-1777, an investigational topical “soft” Janus Kinase (JAK) 1/3 inhibitor compound:
o Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
o ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
● ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
o Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.
Business Development Highlights:
● Aclaris continues to pursue strategic alternatives, including seeking partners for:
o A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
o ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
o ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources
As of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of $68.1 million compared to $75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was $10.8 million and $17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.
Second Quarter 2020 and Year-to-Date Financial Results
● The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations.
● Net loss was $11.6 million for the second quarter of 2020, compared to $49.9 million for the second quarter of 2019, and was $27.2 million for the six months ended June 30, 2020, compared to $87.4 million for the six months ended June 30, 2019.
● Total costs and expenses from continuing operations for the second quarter of 2020 were $13.4 million, compared to $44.5 million for the second quarter of 2019, and were $30.3 million for the six months ended June 30, 2020, compared to $72.8 million for the six months ended June 30, 2019.
o Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of $3.3 million, compared to $4.6 million in the prior year period.
o Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of $6.8 million, compared to $8.9 million in the prior year period.
o Recorded a non-cash goodwill impairment charge of $18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020.
● R&D expenses were $6.5 million and $15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $17.5 million and $37.2 million for the quarter and six months ended June 30, 2019, respectively.
o The quarter-over-quarter decrease of $11.1 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
● General and administrative expenses were $5.6 million and $11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to $7.5 million and $14.9 million for the quarter and six months ended June 30, 2019, respectively.
o The quarter-over-quarter decrease of $1.9 million was primarily the result of lower personnel costs resulting from the Company’s decision to discontinue commercial operations in September 2019.
● Loss from continuing operations was $11.6 million and $26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $43.7 million and $71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was $27,000 and $0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to $6.2 million and $16.5 million for the quarter and six months ended June 30, 2019, respectively.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D
https://last10k.com/sec-filings/acrs/0001558370-20-009808.ht…
●
First Subject Dosed in Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, as a Potential Treatment for Moderate to Severe Rheumatoid Arthritis
●
First Subject Dosed in Phase 2a Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19
●
Clinical Trial of ATI-1777, an Investigational “Soft” Topical JAK 1/3 Inhibitor, to Proceed in Patients with Moderate to Severe Atopic Dermatitis
WAYNE, Pa., August 7, 2020 (GLOBE NEWSWIRE) – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2020 and provided research and development (R&D) and business highlights.
“As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times,” said Dr. Neal Walker, President and CEO of Aclaris. “In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans.”
R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.
● ATI-450, an investigational oral small molecule MK2 inhibitor compound:
o ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
◾ This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
o ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
o IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
◾ The first subject was dosed in August 2020.
● ATI-1777, an investigational topical “soft” Janus Kinase (JAK) 1/3 inhibitor compound:
o Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
o ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
● ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
o Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.
Business Development Highlights:
● Aclaris continues to pursue strategic alternatives, including seeking partners for:
o A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
o ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
o ESKATA: to commercialize ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:
Liquidity and Capital Resources
As of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of $68.1 million compared to $75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was $10.8 million and $17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.
Second Quarter 2020 and Year-to-Date Financial Results
● The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations.
● Net loss was $11.6 million for the second quarter of 2020, compared to $49.9 million for the second quarter of 2019, and was $27.2 million for the six months ended June 30, 2020, compared to $87.4 million for the six months ended June 30, 2019.
● Total costs and expenses from continuing operations for the second quarter of 2020 were $13.4 million, compared to $44.5 million for the second quarter of 2019, and were $30.3 million for the six months ended June 30, 2020, compared to $72.8 million for the six months ended June 30, 2019.
o Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of $3.3 million, compared to $4.6 million in the prior year period.
o Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of $6.8 million, compared to $8.9 million in the prior year period.
o Recorded a non-cash goodwill impairment charge of $18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020.
● R&D expenses were $6.5 million and $15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $17.5 million and $37.2 million for the quarter and six months ended June 30, 2019, respectively.
o The quarter-over-quarter decrease of $11.1 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
● General and administrative expenses were $5.6 million and $11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to $7.5 million and $14.9 million for the quarter and six months ended June 30, 2019, respectively.
o The quarter-over-quarter decrease of $1.9 million was primarily the result of lower personnel costs resulting from the Company’s decision to discontinue commercial operations in September 2019.
● Loss from continuing operations was $11.6 million and $26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $43.7 million and $71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was $27,000 and $0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to $6.2 million and $16.5 million for the quarter and six months ended June 30, 2019, respectively.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D
https://last10k.com/sec-filings/acrs/0001558370-20-009808.ht…
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