ALKS Alkermes plc

19.02
-0.03  -0%
Previous Close 19.05
Open 19.04
52 Week Low 13.03
52 Week High 23.92
Market Cap $3,028,704,649
Shares 159,237,889
Float 111,921,598
Enterprise Value $2,808,611,785
Volume 1,249,796
Av. Daily Volume 1,211,041
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Upcoming Catalysts

Drug Stage Catalyst Date
ALKS 3831 (olanzapine/samidorphan)
Schizophrenia, bipolar
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
Nemvaleukin (ALKS 4230)
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial to commence 2H 2021.
ALKS 4230 ARTISTRY-1
Solid tumors
Phase 1
Phase 1
Phase 1/2 data presented at ESMO September 18, 2020. 1/5 partial responses in melanoma cohort (monotherapy).
ALKS 4230 (ARTISTRY-3)
Solid Tumors
Phase 3
Phase 3
Phase 2 trial initiation announced August 18, 2020.
Diroximel fumarate (BIIB098)
Multiple sclerosis (MS)
Approved
Approved
FDA Approval announced October 30, 2019.
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - July 30, 2019.
Aristada and Invega Sustenna
Schizophrenia
Phase 3
Phase 3
Phase 3 data released April 9, 2019 - primary endpoint met.
ALKS 5461
Major depressive disorder
CRL
CRL
CRL announced February 1, 2019.
Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD)
Schizophrenia
Approved
Approved
FDA approval announced July 2, 2018.
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
Phase 3
Phase 3
Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
Aristada
Schizophrenia
Approved
Approved
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
BYDUREON
Type 2 diabetes
Approved
Approved
CRL received March 15, 2010.

Latest News

  1. DUBLIN, April 7, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), Alkermes' novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with MSD's KEYTRUDA® (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer. Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.

    "We are pleased to collaborate…

    DUBLIN, April 7, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), Alkermes' novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with MSD's KEYTRUDA® (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer. Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.

    "We are pleased to collaborate with MSD to evaluate nemvaleukin in combination with KEYTRUDA in patients with platinum-resistant ovarian cancer, a patient population for which there are limited treatment options available and overall survival remains low. Importantly, there are no anti-PD-1 treatments currently approved for this tumor type," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "Nemvaleukin in combination with KEYTRUDA has demonstrated antitumor activity in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study, with durable and deepening responses observed. We look forward to initiating this phase 3 study to further evaluate the potential clinical utility of this combination in this tumor type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer."

    About nemvaleukin alfa

    Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

    About the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days, followed by an off-treatment period. In the ongoing phase 2 efficacy expansion stage of ARTISTRY-2, nemvaleukin is administered subcutaneously once every seven days.

    ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of intravenous nemvaleukin monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.

    About Alkermes plc

    Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230) as a cancer immunotherapy when used in combination with KEYTRUDA for the treatment of patients with platinum-resistant ovarian cancer (PROC); plans for initiating a phase 3 study in the second half of 2021; and plans to advance interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether nemvaleukin, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for nemvaleukin will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for nemvaleukin will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for nemvaleukin, including changes relating to the impact of the novel coronavirus (COVID-19) pandemic; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-announces-clinical-trial-collaboration-and-supply-agreement-with-msd-to-evaluate-nemvaleukin-alfa-in-combination-with-keytruda-in-patients-with-platinum-resistant-ovarian-cancer-301263617.html

    SOURCE Alkermes plc

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  2. DUBLIN, March 25, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a virtual fireside chat at Stifel's 3rd Annual CNS Day on Thursday, Apr. 1, 2021 at 8:30 a.m. ET (1:30 p.m. BST). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered…

    DUBLIN, March 25, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a virtual fireside chat at Stifel's 3rd Annual CNS Day on Thursday, Apr. 1, 2021 at 8:30 a.m. ET (1:30 p.m. BST). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-to-take-part-in-stifels-3rd-annual-cns-day-301256281.html

    SOURCE Alkermes plc

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  3. DUBLIN, March 25, 2021 /PRNewswire/ -- Today, Alkermes plc (NASDAQ:ALKS) will host a virtual Investor Day to discuss the company's research and development strategy and portfolio, including updates from its nemvaleukin alfa clinical program and new preclinical neuroscience and immuno-oncology programs. The company will also provide an update on the implementation of its Value Enhancement Plan announced in December 2020.

    "We have reimagined and refocused our approach to research and development. We are leveraging our advanced medicinal chemistry and protein engineering capabilities to develop innovative medicines that we believe have a clear value proposition medicines that have a strong underlying biological rationale and target clear unmet…

    DUBLIN, March 25, 2021 /PRNewswire/ -- Today, Alkermes plc (NASDAQ:ALKS) will host a virtual Investor Day to discuss the company's research and development strategy and portfolio, including updates from its nemvaleukin alfa clinical program and new preclinical neuroscience and immuno-oncology programs. The company will also provide an update on the implementation of its Value Enhancement Plan announced in December 2020.

    "We have reimagined and refocused our approach to research and development. We are leveraging our advanced medicinal chemistry and protein engineering capabilities to develop innovative medicines that we believe have a clear value proposition medicines that have a strong underlying biological rationale and target clear unmet patient need. Nemvaleukin is one of the first demonstrations of this new strategy and the accumulating data from the development program has continued to support its potential utility in difficult-to-treat tumor types," said Richard Pops, Chief Executive Officer of Alkermes. "The innovation happening within our R&D portfolio is complemented by an equal focus on driving value creation for shareholders through our efforts to deliver growth, efficiency and profitability."

    The Investor Day presentations will feature the following topics and speakers:

    Scientific and Business Excellence: Focused on New Approaches to Creating Value

    Richard Pops, Chief Executive Officer

    Value Creation at Alkermes: Innovation, Growth and Profitability 

    Blair Jackson, Executive Vice President, Chief Operating Officer

    Developing New Treatments to Address Unmet Patient Need in Neuroscience and Oncology: Optimizing for Success

    Craig Hopkinson, M.D., Executive Vice President, Chief Medical Officer

    Focus on Innovative Molecular Design: Harnessing Alkermes' Scientific & Technical Capabilities

    Markus Haeberlein, Ph.D., Senior Vice President, Research

    Nemvaleukin alfa: A Novel, Engineered Interleukin-2 (IL-2) Variant Immunotherapy

    Clinical Data Updates from ARTISTRY-1 and ARTISTRY-2 Trials

    Jessicca Rege, Ph.D., Vice President, Clinical Research, Oncology

    Nemvaleukin alfa: Preclinical Research Paving the Clinical Development Path

    Heather Losey, Ph.D., Senior Director, Research, Oncology

    Tumor-Targeted Split IL-12 Fusion Protein Program

    Josh Heiber, Ph.D., Principal Scientist, Research, Oncology

    Selective HDAC Inhibitors in Synaptic Dysfunction

    Markus Haeberlein, Ph.D., Senior Vice President, Research

    Orexin 2 Receptor Agonists for the Treatment of Narcolepsy and Other Sleep Disorders

    Brian Raymer, Ph.D., Senior Director, Research Project Leadership and Strategy

    Webcast Information

    Registration for the webcast is available on the Investors section of the company's website at www.alkermes.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start. A replay of the webcast will be archived on the Investors section of the company's website at www.alkermes.com for 30 days following the presentation.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of the company's development candidates, including nemvaleukin alfa; and the company's focus on driving shareholder value. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, the company's R&D strategy and its focus on driving shareholder value may not be successful; nemvaleukin alfa, as a monotherapy or in combination, could be shown to be unsafe or ineffective; the company's development activities may not be completed on time or at all; the results of the company's development activities may not be positive or predictive of real-world results, and preliminary data from ongoing studies may not be predictive of future or final data from such studies, results of future studies or real-world results; the company and its licensees may not be able to successfully commercialize their products or support growth of revenue from such products; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Alkermes Contacts:

    For Investors: Sandy Coombs      +1 781 609 6377

    For Media:      Katie Joyce   +1 781 249 8927

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-investor-day-to-focus-on-scientific-progress-and-value-creation-strategy-301255568.html

    SOURCE Alkermes plc

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  4. DUBLIN, March 11, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), the company's investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).

    "This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin's potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "The accumulating data from the nemvaleukin program have…

    DUBLIN, March 11, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), the company's investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).

    "This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin's potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "The accumulating data from the nemvaleukin program have continued to support the clinical profile we anticipated in targeting the IL-2 pathway, and we look forward to continuing our momentum with the ARTISTRY development program this year."

    Under the Orphan Drugs Act (ODA), the FDA may grant orphan drug designation to drugs and biologics that are intended to treat diseases or conditions affecting fewer than 200,000 people in the U.S. Orphan drug designation qualifies the drug developer for a variety of development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and seven years of market exclusivity, if approved. For more information on orphan drug designation, please visit the FDA website, available at https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products.

    About nemvaleukin alfa

    Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

    About the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days. In ARTISTRY-2, nemvaleukin is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

    ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of nemvaleukin monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of nemvaleukin as a cancer immunotherapy, including in the treatment of mucosal melanoma; and the company's expectations of continued momentum for the ARTISTRY development program this year. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether nemvaleukin could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for nemvaleukin will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials for nemvaleukin will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for nemvaleukin, including changes relating to impacts of the COVID-19 pandemic on such operations and activities; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.



    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.

    Alkermes Contacts: 

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D., +1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-announces-fda-orphan-drug-designation-for-nemvaleukin-alfa-for-treatment-of-mucosal-melanoma-301245191.html

    SOURCE Alkermes plc

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  5. - Positive Topline Results for LANTERN Phase 2 Study of LYR-210-

    - Robert Kern, MD, appointed Chief Medical Officer -

    - Conference call and webcast today at 4:30 p.m. ET -

    Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    Key Fourth Quarter 2020 and Subsequent Highlights

    • Company Announced Positive Topline Results for LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its…

    - Positive Topline Results for LANTERN Phase 2 Study of LYR-210-

    - Robert Kern, MD, appointed Chief Medical Officer -

    - Conference call and webcast today at 4:30 p.m. ET -

    Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    Key Fourth Quarter 2020 and Subsequent Highlights

    • Company Announced Positive Topline Results for LANTERN Phase 2 Study of LYR-210. In December, Lyra announced positive topline results from its LANTERN Phase 2 study of LYR-210 for the treatment of Chronic Rhinosinusitis, including:
      • LYR-210 is the first nasal implant to achieve a benefit of up to six months after a single administration in a clinical testing, and the first nasal implant to achieve a benefit in both polyp and non-polyp patients in clinical testing.
      • 7500 mcg dose achieved statistically significant improvement in both 4 Cardinal Symptoms and SNOT-22 scores at 24 weeks and at several earlier timepoints, compared to control.
      • Lyra believes the results support a clear path to regulatory submission for LYR-210 and plans to move forward into a pivotal Phase 3 trial using the 7500 mcg dose, subject to an end of Phase 2 meeting with the FDA.

    "The positive results from the LANTERN Phase 2 study point to LYR-210's potential as an easily administered, six-month treatment for CRS patients who have failed medical management," said Professor Anders Cervin, Garnett Passe and Rodney Williams Foundation Chair in Otolaryngology at the University of Queensland, and a Principal Investigator for Lyra's LANTERN trial. "An intranasal implant, like LYR-210, ensures treatment compliance on the part of patients and efficiently delivers drug directly to inflamed tissue. Based on these results, I believe LYR-210 could represent a viable alternative to invasive nasal surgery for CRS patients, with as few as two ENT office visits a year."

    • Appointed Robert Kern, MD, Chief Medical Officer. In February, Lyra announced that Robert Kern, MD had been named the company's Chief Medical Officer. In addition to his role at Lyra, Dr. Kern will remain in his current position as the George A. Sisson Professor and Chair, Department of Otolaryngology – Head and Neck Surgery, Northwestern University Feinberg School of Medicine. Dr. Kern is the immediate past president of the American Rhinologic Society and current President of the International Society of Inflammation and Allergy of the Nose. He is a renowned physician in the ENT field and a world-leading expert in chronic rhinosinusitis with a proven track record of global leadership in otolaryngology, in both academic research and clinical rhinology.
    • Added Nancy L. Snyderman, M.D. to Board of Directors. In October, the company announced that Dr. Snyderman had joined Lyra Therapeutics board. Dr. Snyderman is an accomplished otolaryngologist-head and neck surgeon and healthcare systems expert. She most recently served as Chief Medical Editor at NBC News and has more than three decades of experience as a leading voice in healthcare and medicine. Dr. Snyderman currently serves as a board member of Alkermes (NASDAQ:ALKS) and Axonics Modulation Technologies, Inc. (NASDAQ:AXNX).

    "We were pleased to end our first calendar year as a public company by announcing positive topline data from our LANTERN Phase 2 Study for LYR-210. In addition, we recently strengthened our team with the additions of Dr. Kern to our management team and Dr. Snyderman to our board," said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. "Looking ahead, 2021 should be another pivotal year for Lyra as we read out the data from our PK study and plan to conduct an end of Phase 2 meeting with the FDA for LYR-210, followed by the potential initiation of a Phase 2 study for LYR-220 in the second half, and a Phase 3 pivotal trial of LYR-210 at the end of the year. I look forward to updating you on our progress."

    Financial Highlights

    Cash and cash equivalents as of December 31, 2020 were $74.6 million, compared with $81.6 million as of September 30, 2020.

    Research and development expenses for the quarter and full year ended December 31, 2020 were $3.7 million and $12.5 million, respectively, compared to $3.0 million and $12.0 million for the same periods in 2019, respectively.

    General and administrative expenses for the fourth quarter and full year ended December 31, 2020 were $3.3 million and $9.7 million, respectively, compared to $1.4 million and $4.5 million for the same periods in 2019, respectively.

    Total operating expenses for the quarter ended and full year ended December 31, 2020 were $7.1 million and $22.2 million, respectively, compared to $4.4 million and $16.5 million for the same periods in 2019, respectively.

    Net loss for the fourth quarter and full year 2020 was $7.0 million and $22.1 million, respectively, compared to $4.4 million and $16.3 million for the same periods in 2019, respectively.

    In terms of financial guidance for 2021, we believe that Lyra has sufficient cash to fund the company through planned operations into 2023.

    Conference Call

    Individuals interested in listening to the conference call may do so by dialing (833) 519-1249 for domestic callers, or (914) 800-3822 for international callers, and using the conference ID: 6979948; or from the webcast link in the investor relations section of the company's website at: www.lyratherapeutics.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    Annual Meeting Date

    The Board of Directors of Lyra Therapeutics, Inc. has established May 26, 2021 as the date of its Annual Meeting of Stockholders (the "2021 Annual Meeting"). The 2021 Annual Meeting will be held virtually by means of remote communication. The details of the virtual annual meeting, including how stockholders can log into the virtual meeting, vote and submit questions, will be disclosed in the Company's definitive proxy statement for the 2021 Annual Meeting to be filed with the Securities and Exchange Commission.

    Any stockholder seeking to bring business before the 2021 Annual Meeting or to nominate a director must provide timely notice, as set forth in the Company's Amended and Restated Bylaws (the "Bylaws"). Specifically, written notice of any proposed business or nomination must be received at the Company's principal executive offices no later than the close of business on March 19, 2021 (which is the tenth day following this public announcement of the date of the 2021 Annual Meeting). Any notice of proposed business or nomination must comply with the specific requirements set forth in the Company's Bylaws.

    About Lyra Therapeutics, Inc.

    Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases. The company's lead product candidate, LYR-210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo™ platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines for sustained periods with a single administration.

    For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the company's lead product candidate LYR-210 and its financial guidance for 2021. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the company has incurred significant losses since inception and expects to incur losses for the foreseeable future; the company's need for additional funding, which may not be available; the company's limited operating history; the fact that the company has no approved products; the fact that the company's product candidates are in various stages of development; the fact that the company may not be successful in its efforts to identify and successfully commercialize its product candidates; the fact that clinical trials required for the company's product candidates are expensive and time-consuming, and their outcome is uncertain; the fact that the FDA may not conclude that certain of the company's product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway; the company's inability to obtain required regulatory approvals; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the fact that the successful commercialization of the company's product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and pricing policies; failure to achieve market acceptance; product liability lawsuits; the fact that the company relies on third parties for the manufacture of materials for its research programs, pre-clinical studies and clinical trials; the company's reliance on third parties to conduct its preclinical studies and clinical trials; the company's inability to succeed in establishing and maintaining collaborative relationships; the company's reliance on certain suppliers critical to its production; failure to obtain and maintain or adequately protect the company's intellectual property rights; failure to retain key personnel or to recruit qualified personnel; difficulties in managing the company's growth; effects of natural disasters; the fact that the global pandemic caused by COVID-19 could adversely impact the company's business and operations, including the company's clinical trials; the fact that the price of the company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption "Risk Factors" in the company's Annual Report on Form 10-K filed with the SEC on March 9, 2021 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

    LYRA THERAPEUTICS, INC.

    Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

     

    Year Ended

    December 31,

     

     

     

    2020

     

     

     

     

    2019

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

    $

    12,522

     

     

     

     

    $

    12,032

     

     

    General and administrative

     

     

    9,687

     

     

     

     

     

    4,487

     

     

    Total operating expenses

     

     

    22,209

     

     

     

     

     

    16,519

     

     

    Loss from operations

     

     

    (22,209

    )

     

     

     

    (16,519

    )

    Other income:

     

     

     

     

     

     

     

     

    Interest income

     

     

    82

     

     

     

     

     

    213

     

     

    Total other income

     

     

    82

     

     

     

     

     

    213

     

     

    Net loss

     

    $

    (22,127

    )

     

     

    $

    (16,306

    )

    Comprehensive loss

     

    $

    (22,127

    )

     

     

    $

    (16,306

    )

    Net loss per share attributable to common stockholders—basic and diluted

     

    $

    (2.59

    )

     

    $

    (82.23

    )

    Weighted-average common shares outstanding—basic and diluted

     

     

    8,590,205

     

     

     

     

     

    202,093

     

     

    LYRA THERAPEUTICS, INC.

    Consolidated Balance Sheets

    (in thousands, except share and per share data)

     

     

     

    December 31,

     

     

     

    2020

     

     

     

    2019

     

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    74,593

     

     

     

    $

    9,808

     

     

    Prepaid expenses and other current assets

     

     

    1,324

     

     

     

     

    311

     

     

    Total current assets

     

     

    75,917

     

     

     

     

    10,119

     

     

    Property and equipment, net

     

     

    2,165

     

     

     

     

    237

     

     

    Operating lease right-of-use assets

     

     

    2,301

     

     

     

     

    3,182

     

     

    Restricted cash

     

     

    329

     

     

     

     

    329

     

     

    Other assets

     

     

    118

     

     

     

     

    1,096

     

     

    Total assets

     

    $

    80,830

     

     

     

    $

    14,963

     

     

    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    922

     

     

     

    $

    1,069

     

     

    Accrued expenses and other current liabilities

     

     

    2,977

     

     

     

     

    3,240

     

     

    Operating lease liabilities

     

     

    985

     

     

     

     

    899

     

     

    Total current liabilities

     

     

    4,884

     

     

     

     

    5,208

     

     

    Operating lease liabilities, net of current portion

     

     

    1,454

     

     

     

     

    2,427

     

     

    Total liabilities

     

     

    6,338

     

     

     

     

    7,635

     

     

    Commitments and contingencies (Note 11)

     

     

     

     

     

     

     

     

    Series A-1 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 34,017,033 shares authorized, issued and outstanding at December 31, 2019

     

     

     

     

     

     

    39,742

     

     

    Series A-2 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 26,680,202 shares authorized, issued and outstanding at December 31, 2019

     

     

     

     

     

     

    18,393

     

     

    Series A-3 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 30,070,487 shares authorized, issued and outstanding at December 31, 2019

     

     

     

     

     

     

    38,114

     

     

    Series A-4 redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 19,999,999 shares authorized, issued and outstanding at December 31, 2019

     

     

     

     

     

     

    6,000

     

     

    Series B redeemable convertible preferred stock, $0.001 par value; no shares issued, authorized or outstanding at December 31, 2020; 100,018,619 shares authorized and 98,351,953 shares issued and outstanding at December 31, 2019

     

     

     

     

     

     

    28,417

     

     

    Series C redeemable convertible preferred stock, $0.001 par value; no shares authorized, issued or outstanding at December 31, 2020 and 2019

     

     

     

     

     

     

     

     

    Total redeemable convertible preferred stock

     

     

     

     

     

     

    130,666

     

     

    Stockholders' equity (deficit):

     

     

     

     

     

     

     

     

    Common stock, $0.001 par value; 200,000,000 and 275,000,000 shares authorized at December 31, 2020 and 2019, respectively; 12,932,377 and 230,860 shares issued and outstanding at December 31, 2020 and 2019, respectively

     

     

    13

     

     

     

     

     

     

    Additional paid-in capital

     

     

    224,363

     

     

     

     

    4,419

     

     

    Accumulated deficit

     

     

    (149,884

    )

     

     

    (127,757

    )

    Total stockholders' equity (deficit)

     

     

    74,492

     

     

     

     

    (123,338

    )

    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)

     

    $

    80,830

     

     

     

    $

    14,963

     

     

     

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