2.8500 +0.02 (0.71%)
After hours: 7:56PM EDT
|Bid||2.8300 x 900|
|Ask||2.9000 x 3000|
|Day's Range||2.8100 - 2.9690|
|52 Week Range||1.1300 - 4.3800|
|Beta (5Y Monthly)||0.48|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 05, 2020 - Aug 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||10.00|
Athersys taking a leading role at the International Society of Cell ad Gene Therapy Conference and will discuss MultiStem and the ARDS clinical trial.
Ladies and gentlemen, thank you for standing by, and welcome to the Athersys' first-quarter 2020 results conference call. As Kasie mentioned, I'm Karen Hunady, director of corporate communications and investor relations for Athersys.
Athersys Q1 Earnings reflects multiple achievements for the Company, including obtaining FDA authorization to initiate two additional clinical trials.
When American companies recently applied for U.S. government loans meant to help small businesses survive the coronavirus crisis, they had to certify they needed the cash to cover basic needs like salaries and rent. Forty-one publicly traded companies that got the emergency aid already had enough to cover basic expenses for two months or more when they applied for the funds, a Reuters analysis found -- even if their revenue dropped to zero. Six had enough to last at least until December, according to the review, which was based on average monthly operating expenses from 2019.
Many small biotech players have put the foot on the gas in 2020. With the urgent need for a COVID-19 vaccine and treatment still the number one global priority, this comes as no surprise.Athersys (ATHX) is among those to rise to the challenge and the market has rewarded the micro-cap accordingly. Shares have appreciated by 114% since the turn of the year.Yet, Dawson James analyst Jason Kolbert believes the upward movement has a long way to go.Kolbert reiterated a Buy rating on ATHX shares along with a $12 price target. Investors can expect returns of a whopping 360%, should the target be met over the coming year. (To watch Kolbert’s track record, click here)Following the recent clearance from the FDA, a Phase 2/3 ARDS (acute respiratory distress syndrome) trial has kicked into gear at the University of Cleveland Medical Center (UHC), with the first patient enrolled. The study will evaluate Athersys’ stem cell therapy, Multistem, in patients with moderate to severe ARDS associated with COVID-19. Overall, 400 subjects are expected to enroll in the study with the number of ventilator-free days after 28 days compared to placebo as the primary end point.Last month, Athersys completed a Phase 1/2 study evaluating MultiStem in patients with ARDS. Based on the promising data, the FDA has granted the program Fast Track status.Kolbert believes Athersys’ Multistem “offers great hope for patients suffering from Acute Respiratory Distress Syndrome (ARDS).”Kolbert added, “The data released last month is impressive for a small study and suggests that Multistem has efficacy in ARDS... Multistem works independent of the cause, albeit pneumonia or the coronavirus. As such, it has the potential to be an ideal, first-line defense for patients in respiratory distress… We believe in the potential of Multistem to become a viable treatment option for COVID-ARDS patients.”Over the last 3 months, only one other analyst has thrown the hat in with a review of the micro-cap’s prospects. The additional Buy rating hands ATHX a Moderate Buy consensus rating. The average price target is $6, and implies potential upside of a strong 130%. (See Athersys stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. More recent articles from Smarter Analyst: * Cisco Shares Up Pre-Market After Topping Quarterly Profit Bets * Allogene Explodes 28% After-Hours On Initial ALLO-501 Data * Boeing to Pay Brazil’s Gol $412 Million For 737 MAX Groundings - Report * Wix Reports April Demand Boom, As Revenue Surges 24% Y/Y
The first patients have been enrolled in the Athersys COVID-19 induced ARDS clinical program using MultiStem cell therapy.
Shares of Athersys (NASDAQ: ATHX) declined more than 23% last month, according to data provided by S&P Global Market Intelligence. The stem cell stock's April decline was really just a matter of timing. Athersys has opportunistically positioned itself to respond to the coronavirus pandemic, and has been rewarded by investors.
The first clinical site is now open for the MACOVIA study, a pivotal Phase 2/3 study evaluating MultiStem® cell therapy for COVID-19 induced ARDS
Athersys presentation scheduled for May 14, 2020 at 8:20 AM EDT. A live webcast will be available at https://tinyurl.com/y73g9zud
Promising results from a very small study caused shares of stem cell stocks to soar, but investors shouldn't get too carried away just yet.
Athersys, Inc. (NASDAQ: ATHX) (Athersys) today announced the closing of its previously announced underwritten public offering of 25,587,500 shares of its common stock, par value $0.001 per share (Common Stock), at a price to the public of $2.25 per share, which includes 3,337,500 shares of Common Stock pursuant to the underwriters’ option to purchase additional shares, which the underwriters exercised in full on April 16, 2020. Gross proceeds to Athersys from the offering are approximately $57.6 million, before deducting the underwriting discount and estimated offering expenses.
Athersys, Inc. (NASDAQ: ATHX) (Athersys) today announced the pricing of its previously announced underwritten public offering of its common stock, par value $0.001 per share (Common Stock), at a price to the public of $2.25 per share, for a total of 22,250,000 shares. Gross proceeds to Athersys from the offering are expected to be approximately $50.1 million, before deducting the underwriting discount and estimated offering expenses. In connection with the offering, Athersys has granted the underwriters a 30-day option to purchase up to an additional 3,337,500 shares of Common Stock from Athersys at the public offering price (less the underwriting discount). The offering is expected to close on April 20, 2020, subject to customary closing conditions.
Athersys, Inc. (NASDAQ: ATHX) (Athersys) announced today that it intends to offer for sale $50 million of shares of its common stock, par value $0.001 per share (Common Stock), in an underwritten public offering. In addition, Athersys expects to grant the underwriters a 30-day option to purchase additional shares of Common Stock in an amount of up to 15% of the number of shares of Common Stock offered in the public offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Phase 2 study of cell therapy in trauma expands Company’s clinical programs focused on critical care
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-Week Highs April 14) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * Acceleron Pharma Inc (NASDAQ: XLRN) * Dr.Reddy's Laboratories Ltd (NYSE: RDY) * Kala Pharmaceuticals Inc (NASDAQ: KALA) * Keros Therapeutics Inc (NASDAQ: KROS) (IPOed April 8) * Masimo Corporation (NASDAQ: MASI) * MEI Pharma Inc (NASDAQ: MEIP)(announced a licensing agreement with Japan's Kyowa Kirin for developing its ME-401, which is being evaluated for B-cell malignancies) * Neoleukin Therapeutics Inc (NASDAQ: NLTX) * Neubase Therapeutics Inc (NASDAQ: NBSE) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN) * SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)(announced appointment of controlling shareholder Robert Duggan as CEO)Down In The Dumps (Biotech Stocks Hitting 52-Week Lows April 14) * Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)(announced a 1-for-20 reverse stock split, effective close of trading Tuesday) * TherapeuticsMD Inc (NASDAQ: TXMD)See Also: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate UseStocks In Focus Pfenex Says FDA Requests Additional Data For Establishing Bioequivalence Of Osteoporosis Drug To Forteo Pfenex Inc (NYSE: PFNX) said the FDA informed its commercialization partner Alvogen Malta Operations through a General Advice letter, additional comparative use human factors data, especially from Forteo experienced users, would be required before PF708 Therapeutic Equivalence could be determined.Forteo is Eli Lilly And Co's(NYSE: LLY) drug indicated to treat ostmenopausal women with osteoporosis at high risk for fracture."We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency's expressed views, so that we can submit additional data as soon as possible," said Eef Schimmelpennink, CEO of Pfenex.The company also said it will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek "A" therapeutic equivalence designation.Crinetics Announces 7.15M Common Stock Offering Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) priced its underwritten public offering of 7.15 million shares at $14 per share. All the shares are being offered by the company. The company expects to raise gross proceeds of $100.1 million from the offering. The offering is expected to close on or about April 17.The company said it intends to use the net proceeds to fund the development of paltusotine and other R&D programs, and for working capital and general corporate purposes.Athersys Given Go Ahead To Initiate Midstage Study Of Stem Cell Therapy For Traumatic Injuries Athersys Inc (NASDAQ: ATHX) said the FDA has authorized an IND to initiate a Phase 2 study evaluating its MultiStem cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma.Applied DNA Ships 5 Vaccine Constructs To Begin Animal Testing In Italy Applied DNA Sciences Inc (NASDAQ: APDN) said it has completed design, qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech to start preclinical testing immediately. The vaccine candidates, according to the company, were produced by its proprietary PCR-based Linear DNA manufacturing systems."Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA's linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates," said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech.In pre-market trading, shares were surging up 43.96% to $6.55.Merck Announces U.S. Launch Of Biosimilar For Roche's Popular Breast Cancer Drug Merck & Co., Inc. (NYSE: MRK) announced the U.S. launch of Ontruzant, a biosimilar of the reference biologic medicine Herceptin - Roche Holdings AG's (OTC: RHHBY) breast cancer drug.The company noted that the biosimilar will be available in both 150 mg single-dose vials, priced at WAC of $1,325, and 420mg multiple-dose vials, priced at $3,709. This represented a 15% discount to the current list price of Herceptin.Ontruzant is developed by Samsung Bioepis, with Merck assuming the responsibility of the commercialization of the biosimilar in the U.S.In pre-market trading, Merck shares were slipping 1.44% to $81.65.Mallinckrodt Announces Publication Of Positive Efficacy Data For Acthar Gel Mallinckrodt PLC (NYSE: MNK) announced the publication of findings from a Phase 4 study to assess the safety and efficacy of Acthar Gel in patients with persistently active rheumatoid arthritis, with Acthar Gel demonstrating the potential for effectiveness in achieving low disease activity as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.The stock was gaining 1.53% to $3.99 in pre-market trading.Oragenics' Antibiotic Candidate Flunks Midstage Study In Treating Oral Mucositis Oragenics Inc (NYSE: OGEN) said early top-line results of the company's Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo.The stock slumped 46.20% to 43 cents in premarket trading Wednesday.On The Radar Clinical Readouts Vir Biotechnology Inc (NASDAQ: VIR) will present at a Key Opinion leader call an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218, Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY).See more from Benzinga * The Week Ahead In Biotech: Spotlight On Q1 Pre-Announcements As COVID-19 Continues To Disrupt Operations * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test * The Daily Biotech Pulse: Setback For DBV In Peanut Allergy Patch Review, Roche Starts Coronavirus Test Shipment, Regeneron Aims For 'Cocktail' COVID-19 Treatment(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
As the COVID-19 pandemic continues to ravage the globe, having claimed over 115,000 lives, health care companies have are pursuing diagnostics tests, potential vaccines and therapies.The following companies provided updates Monday on their coronavirus programs.Biocept To Accept COVID-19 Testing Requests San Diego, California-based Biocept Inc (NASDAQ: BIOC), a provider of liquid biopsy tests, said in a Thursday press release that it intends to begin accepting physician-ordered COVID-19 molecular diagnostic testing requests for processing beginning April 15. Biocept said it has partnered with a national clinician network to accept patient samples and may obtain additional agreements as test capacity is increased. The company's lab will use the FDA-approvedThermo Fisher Scientific Inc. (NYSE: TMO) Scientific TaqPath and kit for SARS-CoV2, which received Emergency Use Authorization from the FDA. "I am very thankful to our laboratory team for stepping up and quickly validating COVID-19 testing, in addition to the vital work we do each day for patients diagnosed with cancer," Biocept CEO Mike Nall said in a statement. Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates BioCryst Opens Enrollment In Brazilian Trial Of Potential SARS-CoV-2 Treatment BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) said it has opened enrollment into a randomized, double-blind, placebo-controlled clinical study to assess the efficacy and antiviral effects of its galidesivir in patients with COVID-19.The trial will be funded by the National Institute of Allergy and Infectious Diseases, according to the company. Galidesivir is an investigational broad-spectrum antiviral drug that was found to be safe and well-tolerated in an Phase 1 trial conduced in healthy subjects, BioCryst said. It also showed broad-spectrum activity in labs against more than 20 RNA viruses belonging to nine families, including the coronaviruses that cause MERS and SARS.The company said the planned trial will be conducted in Brazil under a U.S. IND, and the protocol has been approved by the Brazilian regulatory agencies."We have begun to see COVID-19 cases in Brazil, and we have a good opportunity to enroll and treat patients earlier in their disease course to determine if galidesivir can benefit patients with COVID-19," said Dr. Esper Kallas, principal investigator of the study.Athersys Gets FDA Nod For Pivotal Phase 2/3 Study Of MultiStem Therapy For COVID-19 Induced ARDS Athersys Inc (NASDAQ: ATHX) said the FDA has authorized the company to initiate a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStem therapy in subjects with moderate-to-severe acute respiratory distress syndrome, or ARDS, induced by the COVID-19 disease.Since the program falls under the company's current IND application for its completed MUST-ARDS study, it is not required to file a new IND.Athersys said it plans to open the first clinical sites for recruitment of the MACOVIA study this quarter. Can-Fite To Begin Enrollment, Dosing In COVID-19 Trial Immediately Can-Fite BioPharma Ltd. (NYSE: CANF) said it has received approval from the Institutional Review Board at Israel's Rabin Medical Center to initiate a pilot clinical study of its drug candidate Piclidenoson for the treatment of moderate-to-severe symptoms in coronavirus infected patients.The company announced in late March that it has submitted Piclidenoson to the institute for a COVID-19 compassionate use program.Patient enrollment and dosing will begin immediately, the company said."Piclidenoson's anti-viral, anti-inflammatory, and anti-rheumatic properties combined with its excellent safety profile make it a strong candidate for the potential treatment of coronavirus," Dr. Pnina Fishman, CEO of Can-Fite, said in a statement. Price Action * Biocept shares were jumping 63.3% to 58 cents at the time of publication Monday. * BioCryst shares were gaining 21.27% to trade at $2.51. * Athersys was moving up 8.59% to $3.16. * Can-Fite shares were surging 44.83% to $2.10. Related Link: Morgan Stanley Downgrades Lilly On Valuation, Says Growth, Pipeline Potential Balanced By Stock Premium See more from Benzinga * The Daily Biotech Pulse: Novartis Scraps Deal To Sell Sandoz Assets, Nevro Pre-Announces Q1 Shortfall, Affimed Granted Orphan Drug Designation * The Daily Biotech Pulse: InflaRx Begins Human Testing For COVID-induced Pneumonia, Chembio, Becton Dickinson Launch Coronavirus Tests * The Daily Biotech Pulse: Amarin Faces Legal Setback, Milestone Payment Kicks In For CytomX, Savara, Reata Disclose COVID-19 Disruptions(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Shares in Athersys, Inc. (ATHX) soared more than 20% in U.S. premarket trading after the biotech company announced that it was granted approval by the Food and Drug Administration (FDA) to start a pivotal clinical study of its stem-cell therapy on patients with COVID-19-induced acute respiratory distress syndrome (ARDS).Following the FDA approval, Athersys said it plans this quarter to initiate a phase 2/3 pivotal study to determine the safety and efficacy of its MultiStem therapy in coroanavirus patients with moderate to severe acute respiratory distress syndrome. The study conducted among 400 individuals will be administered at leading pulmonary critical care centers throughout the U.S., the company announced. According to the World Health Organization (WHO) and other recent clinical and epidemiological data, ARDS is the leading cause of death among COVID-19 infected patients.“We believe that MultiStem treatment, by modulating patients’ hyperinflammatory response to highly pathogenic respiratory viruses, including SARS-CoV-2 which causes COVID-19, represents a very promising approach to improving outcomes in patients who suffer the most severe manifestations of these illnesses,” said Eric Jenkins, MD, Senior Medical Director and Head of Clinical Operations at Athersys. “We are in communication with FDA regarding the enrolment of further cohorts to conduct a scientifically rigorous evaluation of MultiStem’s safety and efficacy in the treatment of ARDS due to COVID-19.”Athersys said it recently completed a Phase 1/2 study evaluating administration of its MultiStem therapy in patients with ARDS and based on the “promising data” from the study, the program was granted Fast Track approval by the FDA.Athersys jumped more than 20% to as high as $3.71 in premarket trading on Monday. In March, Jason Kolbert, analyst at Dawson James raised Athersys 12-month price target to $12 from $11 while maintaining a Buy rating. Needham’s Chad Messer is less aggressive on potential upside for the company’s shares putting the price target at $6, while also holding on to a Buy rating. (See Athersys stock analysis on TipRanks).At the end of March, Japanese drugmaker Healios piled up on another 4 million of Athersys’ stock at $1.76 a share, providing just over $7 million in new funding for the regenerative medicines company. Following the purchase, Healios' equity stake in Athersys increased to 12 million shares, or about 9.4% of its outstanding stock.Related News: Pfizer Joins Virus Vaccine Hunt in Partnership With German Drugmaker Gilead’s Experimental Coronavirus Drug Shows “Hopeful” Signs in Small Group Microsoft’s Bill Gates to Spend Billions of Dollars on Coronavirus Vaccine Development More recent articles from Smarter Analyst: * Chipotle 1Q Sales Rise Fueled By Record Digital Sales Growth * Snap Quarterly Revenue Jumps 44% as Coronavirus Pandemic Boosts Snapchat Users; Shares Soar 20% in Pre-Market Trading * Exact Sciences Reports 63% Reduction For Cologuard Testing in April * Netflix Wins 15.8 million subscribers in Q1, Sees Growth Slowing in Virus Aftermath
Shares of Athersys Inc. shot up 26.5% in premarket trading Monday, after the company said it has received Food and Drug Administration authorization to start a phase 2/3 trial to assess safety and efficacy of its MultiStem therapy on patients with COVID-19-induced acute respiratory distress syndrome (ARDS). The biotechnology company said it plans to open the first sites for recruitment of the study this quarter. ARDS is the leading cause of death among COVID-19 infected patients, according to the World Health Organization (WHO). "Since MultiStem is not virus- or pathogen-specific, we believe it has the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS," the company said. The stock has more than doubled (up 120.5%) over the past three months, while the S&P 500 has lost 15.2%.
Company plans to initiate a Phase 2/3 pivotal study in patients with COVID-19 induced ARDS this quarter
Healios purchased 4,000,000 shares representing an additional investment of $7,040,000 in Athersys.
Maia Hansen appointed to help Athersys to establish and manage a sustainable supply chain to support commercial success.