CDAK Codiak BioSciences Inc.

13.29
-1.04  -7%
Previous Close 14.33
Open 13.81
52 Week Low 8.57
52 Week High 37.85
Market Cap $297,240,844
Shares 22,365,752
Float 13,073,015
Enterprise Value $284,371,226
Volume 23,870
Av. Daily Volume 57,586
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Upcoming Catalysts

Drug Stage Catalyst Date
exoSTING (CDK-002)
Solid tumors
Phase 1/2
Phase 1/2
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exoIL-12
Cutaneous T cell lymphoma
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
exoASO-STAT6
Hepatocellular carcinoma
Phase 1
Phase 1
IND expected YE 2021.

Latest News

  1. – exoSTING resulted in localized STING pathway activation and dose-dependent immune activation –

    – Intratumoral administration of exoSTING was well tolerated and demonstrated tumor retention, no systemic exposure to STING agonist, and in a subset of patients, tumor shrinkage in injected and distal non-injected lesions –

    – Data on objective response rate and recommended Phase 2 dose selection for expansion anticipated 1H 2022 –

    – Codiak to host conference call and webcast today at 8:00 am ET –

    CAMBRIDGE, Mass., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced…

    – exoSTING resulted in localized STING pathway activation and dose-dependent immune activation –

    – Intratumoral administration of exoSTING was well tolerated and demonstrated tumor retention, no systemic exposure to STING agonist, and in a subset of patients, tumor shrinkage in injected and distal non-injected lesions –

    – Data on objective response rate and recommended Phase 2 dose selection for expansion anticipated 1H 2022 –

    – Codiak to host conference call and webcast today at 8:00 am ET –

    CAMBRIDGE, Mass., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced positive initial data for exoSTING, a novel engineered exosome therapeutic candidate currently being investigated in a Phase 1/2 clinical trial as a single agent for the treatment of multiple solid tumors.

    "We are excited to see that the initial foundational data from our exoSTING program are consistent with the pharmacologic activity that we observed with the candidate preclinically, and point to a differentiated mechanism of action afforded by the engineered exosome-based delivery of the STING agonist," said Doug Williams, PhD, CEO of Codiak. "The targeted delivery and tumor retention observed so far appear to effectively engage the STING pathway, and at tested doses, exoSTING was well tolerated and showed initial signals of clinical activity. These data also reinforce our conviction that our engineering platform enables the specific design of therapeutic molecules with desired attributes to effectively modulate important targets that have not been successfully drugged before."

    In the first three dose cohorts of trial participants treated with exoSTING in this ongoing dose-escalation study, evidence of local STING pathway activation and stimulation of both innate and adaptive immune responses were observed at all tested doses (0.3 mcg, 1.0 mcg, and 3.0 mcg). Intratumoral injection of exoSTING did not lead to systemic exposure to the STING agonist and was well tolerated at all dose levels tested. Additionally, pharmacodynamic data indicated that intratumoral administration of exoSTING was >100-fold more potent than data reported in prior published STING agonist clinical studies. Analysis of blood cells after exoSTING dosing showed the migration of activated cells from the tumor, and in some subjects, substantial induction of Interferon Stimulated Genes (ISG), which are involved in interferon response and activation of antigen presenting cells (APCs). Tumor shrinkage of injected and non-injected lesions were noted in a subset of subjects.

    exoSTING is one of the first engineered exosome therapeutic candidates to be evaluated in humans and one of two Codiak programs currently in clinical development. exoSTING was engineered with the company's proprietary engEx™ Platform and designed to deliver Codiak's proprietary STING (Stimulator of Interferon Genes) agonist specifically to tumor-resident APCs to locally activate the innate immune response and to generate an adaptive immune response by presenting tumor antigens to T cells.

    The STING pathway is a validated drug target, yet therapeutic development has been generally limited by lack of tumor retention, tolerability issues due to systemic exposure to the agonist and T-cell ablation in the tumor at higher agonist doses, resulting in the inability to effectively engage the pathway. In preclinical models of exoSTING, the targeted delivery of a STING agonist to tumor resident APCs promoted localized innate immune activation, T cell attraction and expansion in the tumor, and the development of systemic immunity not observed with a STING agonist delivered without exosomes (e.g., "free").

    Initial Data from Dose Cohorts 1-3

    The initial data are being reported from the first three ascending dose cohorts (0.3 mcg, 1.0 mcg, and 3.0 mcg) enrolled in the Phase 1/2 study. Trial participants (n=11) were administered exoSTING intratumorally and all subjects had received at least two prior therapies prior to study entry with most (73%) having progressed on checkpoint inhibitors.

    Plasma pharmacokinetic (PK) measurements of subjects that received exoSTING showed no systemic exposure to the agonist. Further, analyses of available plasma biomarkers indicated a lack of systemic inflammatory cytokines detectable in blood after exoSTING administration.

    Within the first three dose cohorts, exoSTING was generally well tolerated and no treatment-related adverse events were observed through the 28-day follow-up period and beyond.

    Blood biomarker assessments conducted post dosing showed evidence of dose-dependent activation of the STING pathway and Type I INF induction along with CXCL10, indicating activation of the innate immune response. Paired tumor biopsies available from two subjects showed evidence of an adaptive immune response and CD8 effector T cell infiltration into the tumor, as well as an increase in PD-L1 expression.

    Finally, in subjects evaluable for early signs of antitumor activity (n=8), tumor shrinkage was observed in injected as well as distal, non-injected tumors, in a subset of subjects.

    Enrollment in cohorts 4 (6 mcg) and 5 (12 mcg) of the exoSTING trial is ongoing. Data from all five cohorts including objective response data are expected in the first half of 2022, which will enable identification of a recommended Phase 2 dose.

    exoSTING Development and Ongoing Phase 1/2 Clinical Trial

    The Phase 1/2 dose escalation clinical trial of exoSTING is designed to investigate safety, tolerability, pharmacological activity, and objective tumor response in patients with advanced/metastatic, recurrent, injectable solid tumors, with a focus on tumors likely to be enriched in APCs. As part of the Phase 2 portion of the trial, Codiak intends to enroll further expansion cohorts of patients at the optimal exoSTING dose to be identified in the Phase 1 portion of the clinical program.

    About exoSTING™

    exoSTING is Codiak's exosome therapeutic candidate engineered to incorporate a proprietary STING (Stimulator of Interferon Genes) agonist inside the lumen of the exosome while expressing the exosomal protein, PTGFRN, on the exosome surface to facilitate specific uptake in tumor-resident antigen presenting cells. Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and to enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.

    Conference Call and Webcast

    Codiak will host a conference call and webcast today at 8:00 a.m. ET. The webcast may be accessed through the "News & Events" page in the "Investors & Media" section of Codiak's website at https://ir.codiakbio.com/news-events. A PDF of the accompanying slides will be available for download. Phone participants in the U.S and Canada may dial (800) 385-9715 and refer to conference ID 8863323 (international callers please use (409) 937-8965). To ensure timely access to the event, participants are encouraged to connect to the call 10 minutes before the start time or to use the webcast link for listen-only access.

    The archived webcast will be available on Codiak's website beginning approximately two hours after the event and will be available for replay for at least 90 days after the event.

    About Codiak BioSciences

    Codiak is a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of diseases, spanning oncology, neuro-oncology, infectious disease and rare disease. 

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING, including expected design of clinical trials and timing of availability and release of data, and statements regarding the capabilities and potential of Codiak's engEx Platform and engineered exosomes generally. In addition, Codiak has not conducted any head-to-head clinical studies that compare exoSTING to another drug product, whether investigational or approved. Information regarding other drug products in this news release is meant to provide context for illustrative purposes only. Because there are no head-to-head clinical studies, no conclusions should be made based on cross study comparison. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Codiak's Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak's subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.



    Investor Contact
    Christopher Taylor
    VP, Investor Relations and Corporate Communications
    T: 617-949-4220
    E: 
    
    Media Contact
    Lindy Devereux
    Scient PR
    T: 646-515-5730
    E: 

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  2. – exoSTING™ monotherapy suppressed tumor growth and improved overall survival in a preclinical model of leptomeningeal disease, an aggressive metastasis of cancer to the central nervous system –

    – Combination of exoSTING™ and exoIL-12™ generated abscopal effect in solid tumor preclinical models and achieved 100% complete responses when dosed with anti PD-1 checkpoint inhibitor –

    – exoASO™-STAT6 demonstrated unique monotherapy efficacy with systemic dosing, supporting planned clinical studies in hepatocellular carcinoma and myeloid rich tumors; IND expected by year end –

    CAMBRIDGE, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development…

    – exoSTING™ monotherapy suppressed tumor growth and improved overall survival in a preclinical model of leptomeningeal disease, an aggressive metastasis of cancer to the central nervous system –

    – Combination of exoSTING™ and exoIL-12™ generated abscopal effect in solid tumor preclinical models and achieved 100% complete responses when dosed with anti PD-1 checkpoint inhibitor –

    – exoASO™-STAT6 demonstrated unique monotherapy efficacy with systemic dosing, supporting planned clinical studies in hepatocellular carcinoma and myeloid rich tumors; IND expected by year end –

    CAMBRIDGE, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced that new preclinical data from programs using its engEx™ Platform will be presented this week at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021). Results from three preclinical studies highlight the potential for engineered exosomes to elicit a therapeutic immunological response with cancers and targets that have been historically difficult to drug, presenting new potential applications for the company's clinical and preclinical candidates.

    "Our data at SITC this year showcase our innovation with engineered exosome therapeutics in the immuno-oncology space and underscore the ability of these exosomes to activate immune cells and induce powerful, targeted responses in disease pathways where this has been exceedingly difficult to achieve using traditional therapeutic approaches," said Sriram Sathyanarayanan, Ph.D., Chief Scientific Officer, Codiak. "For example, the data from our exoSTING program in leptomeningeal disease models show for the first time that engineered exosomes, when administered into the CNS compartment, can selectively target immune cells in the meninges and generate anti-tumor activity in this aggressive model. As we continue to progress and expand our pipeline, we are encouraged by the growing body of evidence that clearly supports that engineered exosome therapeutics may be able to address diseases with no existing treatments or where available options have limited efficacy."

    Codiak's proprietary engEx Platform enables the company to engineer exosomes – naturally occurring, extracellular nanoparticle vesicles – with distinct properties, load them with various therapeutic molecules and alter tropism so they reach specific cellular targets. Codiak has two programs currently in clinical development, exoIL-12 and exoSTING, for the treatment of lymphoid and solid tumors, respectively. In addition, the company expects to file an IND for exoASO-STAT6 – a novel exosome therapeutic carrying an antisense oligonucleotide (ASO) to target the transcription factor, STAT6 – in Q4 2021.

    Codiak is presenting the following three posters at SITC 2021:

    exoSTING Demonstrates Potent Anti-Tumor Activity in a Mouse Model of Leptomeningeal Disease (#761)

    exoSTING, a novel exosome therapeutic exogenously loaded with a STING agonist, has previously demonstrated enhanced potency, preferential activation of antigen presenting cells in the tumor microenvironment, and systemic anti-tumor immunity in vivo when administered intratumorally. In a mouse model of leptomeningeal disease (LMD), an aggressive cancer of the central nervous system that occurs when primary tumors, typically from lung, breast and melanoma cancers, spread to the intracranial space, exoSTING improved overall survival in a dose-dependent manner with 100% complete response rates observed in the three highest doses tested. Further analyses showed localized anti-tumor immune response associated with exoSTING, including infiltration of tumor-specific T cells and macrophages and evidence of immunological memory without systemic inflammation.

    Combination Therapy of exoSTING and exoIL-12 Activates Systemic Anti-Tumor Immunity (#572)

    exoIL-12 is a novel exosome therapeutic engineered to overexpress the potent cytokine, IL-12. Both exoSTING and exoIL-12, when administered as a monotherapy, elicit potent and selective immune responses in preclinical tumor models. Data presented at SITC 2021 show that the combination of the two therapies together resulted in increased anti-tumor activity in both injected and non-injected tumor models compared to each therapy administered alone. Specifically, the combination provided 93% and 78% tumor growth inhibition (TGI) in injected and non-injected tumors, respectively, in an anti-PD-1 refractory melanoma tumor model, compared to 44% TGI in non-injected tumors with exoSTING and 48% with exoIL-12 alone. This abscopal effect was also observed in multiple subcutaneous colorectal tumor and melanoma models when exoSTING and exoIL-12 were added to an anti-PD-1 checkpoint inhibitor. This triple combination resulted in up to 100% complete responses in both injected and non-injected tumors and, upon rechallenge, no new tumors grew, demonstrating lasting immunological memory. Subsequent analyses revealed enhanced T cell infiltration in the non-injected tumors associated with the combination therapy, suggesting that exosome-based immunotherapy can elicit an immune response that is both tumor-specific and systemic.

    Exosome Mediated Reprogramming of Tumor Associated Macrophages by exoASO-STAT6 for the Treatment of Hepatocellular Carcinoma (HCC) (#842)

    exoASO-STAT6 is Codiak's first systemically administered exosome therapeutic candidate and, through the natural tropism of exosomes, is active in liver models, making it a potentially attractive candidate for treating hepatocellular carcinoma (HCC). Preclinical data presented at SITC 2021 demonstrate the ability of exoASO-STAT6 as a single agent to effectively target and ‘reprogram' immunosuppressive macrophages to a pro-inflammatory phenotype and to generate robust anti-tumor activity. When administered intravenously in preclinical models of HCC, exoASO-STAT6 demonstrated:

    • Dose-dependent and durable oligonucleotide accumulation in liver models;
    • Significant and durable STAT6 mRNA knockdown in murine and NHP models;
    • Attenuation of tumor growth, including complete remission of tumor lesions in 50% of treated mice;
    • Enhanced anti-tumor activity (75% complete remissions) when combined with anti-PD1 antibodies; and
    • Consistent PK, PD and effective STAT6 silencing across in vitro and multiple in vivo settings

    The posters are available on the Publications & Presentations page under the Our Science section of Codiak's website.

    About exoSTING™

    exoSTING is Codiak's exosome therapeutic candidate engineered to incorporate a proprietary STING (stimulator of interferon genes) agonist inside the lumen of the exosome while expressing the exosomal protein, PTGFRN, on the exosome surface to facilitate specific uptake in tumor-resident antigen presenting cells (APCs). Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.

    Codiak is developing exoSTING for the treatment of multiple solid tumors enriched in the target APCs. exoSTING has demonstrated encouraging activity in preclinical models and is now being evaluated in a Phase 1/2 clinical trial in patients with advanced/metastatic, recurrent, and injectable solid tumors.

    About exoIL-12™

    exoIL-12 is Codiak's exosome therapeutic candidate engineered to display fully active IL-12 on the surface of the exosome, using the exosomal protein, PTGFRN, as a scaffold, and designed to facilitate potent local pharmacology at the injection site with precisely quantified doses. By limiting systemic exposure of IL-12 and associated toxicity, Codiak hopes to enhance the therapeutic index with exoIL-12, delivering a more robust tumor response, dose control and an improved safety profile.

    Codiak intends to focus development of exoIL-12 on tumors that have, in previous clinical testing, shown clinical responses to recombinant IL-12 used as a monotherapy. This list includes cutaneous T cell lymphoma (CTCL), melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme, and triple negative breast cancer, among others. exoIL-12 is currently being evaluated in a Phase 1 clinical trial in patients with CTCL.

    About exoASO™-STAT6

    exoASO-STAT6 is an exosome engineered to deliver antisense oligonucleotides and selectively target uptake in M2 polarized tumor-associated macrophages via overexpression of the exosomal protein, PTGFRN. Targeting STAT6 acts as a potent switch of the polarization of tumor-associated macrophages from an M2 tumor permissive/anti-inflammatory phenotype to an M1 T cell attractive, anti-tumor/inflammatory phenotype. Codiak plans to initially develop exoASO-STAT6 for primary and metastatic cancers of the liver, such as hepatocellular carcinoma, pancreatic ductal adenocarcinoma, colorectal carcinoma, lung adenocarcinoma, uveal melanoma, glioma, thyroid cancer and ovarian cancer.

    About the engEx™ Platform

    Codiak's proprietary engEx Platform is designed to enable the development of engineered exosome therapeutics for a wide spectrum of diseases and to manufacture them reproducibly and at scale to pharmaceutical standards. By leveraging the inherent biology, function and tolerability profile of exosomes, Codiak is developing engEx exosomes designed to carry and protect potent drug molecules, provide selective delivery and elicit the desired pharmacology at the desired tissue and cellular sites. Through its engEx Platform, Codiak seeks to direct tropism and distribution by engineering exosomes to carry on their surface specific targeting drug moieties, such as proteins, antibodies/fragments, and peptides, individually or in combination. Codiak scientists have identified two exosomal proteins that serve as surface and luminal scaffolds. By engineering the exosome surface or lumen and optimizing the route of administration, Codiak aims to deliver engEx exosomes to the desired cell and tissue to more selectively engage the drug target, potentially enhancing the therapeutic index by improving potency and reducing toxicity.

    About Codiak BioSciences

    Codiak is a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, infectious disease and rare disease.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING, exoIL-12 and exoASO-STAT6, including future development plans and regulatory filings and timing with respect thereto. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Codiak's Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak's subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law. 



    Investor Contact:
    Christopher Taylor
    VP, Investor Relations and Corporate Communications
    T: 617-949-4220
    E: 
    
    Media Contact:
    Lindy Devereux
    Scient PR
    T: 646-515-5730
    E: 

    Primary Logo

    View Full Article Hide Full Article
  3. – Announced strategic long-term exosome manufacturing collaboration with Lonza –

    – Initial data readout from exoSTING™ clinical trial expected in Q4 2021; initial data from exoIL-12™ trial in CTCL patients now anticipated in H1 2022 –

    – Investigational New Drug (IND) application filing for exoASO™-STAT6 expected in Q4 2021 –

    – Preclinical data showing new potential therapeutic applications for three engineered exosome candidates to be presented during SITC 2021 next week –

    CAMBRIDGE, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today reported third quarter 2021…

    – Announced strategic long-term exosome manufacturing collaboration with Lonza –

    – Initial data readout from exoSTING™ clinical trial expected in Q4 2021; initial data from exoIL-12™ trial in CTCL patients now anticipated in H1 2022 –

    – Investigational New Drug (IND) application filing for exoASO™-STAT6 expected in Q4 2021 –

    – Preclinical data showing new potential therapeutic applications for three engineered exosome candidates to be presented during SITC 2021 next week –

    CAMBRIDGE, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today reported third quarter 2021 financial results and recent operational progress.

    "We made steady progress in the third quarter toward our goals for Codiak's pipeline," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "Patient dosing and follow up in the Phase 1/2 trial of exoSTING has proceeded well, and we anticipate providing preliminary safety and pharmacologic data in patients from the initial dose escalation cohorts shortly. Enrollment in the CTCL portion of our exoIL-12 Phase 1 trial has ramped more slowly than anticipated due predominantly to COVID-related restrictions in the UK, and based on the latest correspondence with our sites, we now estimate that data will be available in the first half of next year. Our recently announced strategic collaboration with Lonza affirms that we are at the forefront of a promising new therapeutic modality. This partnership will expand and accelerate the creation of new exosome production technologies and secures a manufacturing partner for our later-stage clinical and potential commercial material."

    Third Quarter 2021 and Recent Highlights

    • Entered into strategic exosome manufacturing collaboration with Lonza, which includes the pending acquisition of Codiak's manufacturing site in Lexington, MA and the formation of a joint Center of Excellence for exosome manufacturing. Under terms of the agreement, Codiak will receive approximately $65 million of in-kind manufacturing services for its clinical-stage programs, while retaining its core exosome engineering and loading expertise and pipeline. Lonza will assume operation of the Lexington facility.
    • Continued to progress subject dosing and follow up in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors
    • Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003)
    • Completed IND-enabling studies for exoASO-STAT6 (CDK-004) for the intravenous treatment of myeloid-rich cancers
    • Welcomed Lini Pandite, MBChB, MBA to Board of Directors

    Anticipated Milestones and Events

    • Three poster presentations at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021) on November 12 and 13, including new preclinical data on exoASO-STAT6 in hepatocellular carcinoma, exoSTING in leptomeningeal disease and the combination of exoSTING and exoIL-12 in solid tumors
    • Initial safety, PK, and PD data from dose escalation cohorts 1-3 on the Phase 1/2 trial of exoSTING in patients with advanced/metastatic solid tumors with injectable lesions expected in the fourth quarter of 2021
    • IND filing for exoASO-STAT6 anticipated during the fourth quarter of 2021
    • Initial safety, PK/PD and efficacy data in CTCL patients are now expected in the first half of next year due predominantly to COVID-related restrictions in the U.K. that are impacting the Phase 1 clinical trial sites for exoIL-12

    Third Quarter 2021 Financial Results

    Total revenues for the quarter ended September 30, 2021, were $1.2 million, compared to $1.0 million for the same period in 2020. This increase was due to deferred revenue recognized from ongoing research and development collaborations.

    Net loss for the quarter ended September 30, 2021, was $21.7 million, compared to a net loss of $35.3 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx™ Platform.

    Research and development expenses were $15.5 million for the quarter ended September 30, 2021, compared to $30.6 million for the same period in 2020. The decrease in research and development expenses in the third quarter reflects a one-time payment to Kayla Therapeutics S.A.S. under a license agreement in the prior year, partially offset by increases in personnel costs and other engEx Platform costs, including manufacturing and preclinical costs as we progressed Codiak's lead candidates into the clinic.

    General and administrative expenses were $7.2 million for the quarter ended September 30, 2021, compared to $5.3 million for the same period in 2020. The increase was driven primarily by an increase in general business expenses, including corporate insurance costs, and additional general and administrative headcount to support our overall growth and our transition to becoming a public company.

    As of September 30, 2021, Codiak had cash and cash equivalents of approximately $98.6 million.

    About Codiak BioSciences

    Codiak is a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, neurology, and infectious disease.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING and exoIL-12, including timing of release of data from clinical trials and the results of those trials, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of clinical trials, and statements regarding the capabilities and potential of Codiak's engEx Platform and engineered exosomes generally. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Codiak's Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak's subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.

    - financial tables follow –

    CODIAK BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, in thousands, except share and per share data)

      SEPTEMBER 30,

    2021
      DECEMBER 31,

    2020
     
    Assets      
    Current assets:      
    Cash and cash equivalents $98,584  $88,915 
    Prepaid expenses and other current assets  5,329   4,843 
    Total current assets  103,913   93,758 
    Property and equipment, net  29,384   31,410 
    Restricted cash, net of current portion  4,170   4,170 
    Operating right-of-use assets  21,258   22,003 
    Total assets $158,725  $151,341 
    Liabilities and Stockholders' Equity      
    Current liabilities:      
    Accounts payable $1,998  $2,018 
    Accrued expenses  9,315   8,870 
    Deferred revenue  9,352   5,281 
    Operating lease liabilities  2,438   1,482 
    Total current liabilities  23,103   17,651 
    Long-term liabilities:      
    Deferred revenue, net of current portion  41,393   57,416 
    Note payable, net of discount  25,352   24,960 
    Operating lease liabilities, net of current portion  34,664   36,540 
    Other long-term liabilities  207  207 
    Total liabilities  124,719   136,774 
    Commitments and contingencies (Note 8)      
    Stockholders' equity:      
    Common stock, $0.0001 par value; 150,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 22,361,305 and 18,787,579 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively  2   2 
    Additional paid-in capital  375,913   302,655 
    Accumulated deficit  (341,909)  (288,090)
    Total stockholders' equity  34,006   14,567 
    Total liabilities and stockholders' equity $158,725  $151,341 



    CODIAK BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited, in thousands, except share and per share data)

      THREE MONTHS ENDED

    SEPTEMBER 30,
      NINE MONTHS ENDED

    SEPTEMBER 30,
     
      2021  2020  2021  2020 
    Revenue:            
    Collaboration revenue $1,157  $954  $15,238  $1,275 
    Total revenue  1,157   954   15,238   1,275 
    Operating expenses:            
    Research and development  15,467   30,640   47,436   60,653 
    General and administrative  7,186   5,342   20,711   13,933 
    Total operating expenses  22,653   35,982   68,147   74,586 
    Loss from operations  (21,496)  (35,028)  (52,909)  (73,311)
    Other income (expense):            
    Interest expense  (689)  (607)  (2,091)  (1,196)
    Interest income  4   4   18   246 
    Other income  479   338   1,163   553 
    Total other expense, net  (206)  (265)  (910)  (397)
    Net loss $(21,702) $(35,293) $(53,819) $(73,708)
    Cumulative dividends on redeemable convertible

    preferred stock
         (3,457)     (10,296)
    Net loss attributable to common stockholders $(21,702) $(38,750) $(53,819) $(84,004)
    Net loss per share attributable to common stockholders,

    basic and diluted
     $(0.97) $(12.83) $(2.49) $(27.92)
    Weighted average common shares outstanding, basic and

    diluted
      22,325,334   3,020,055   21,599,405   3,008,576 
    Comprehensive loss:            
    Net loss $(21,702) $(35,293) $(53,819) $(73,708)
    Other comprehensive loss:            
    Unrealized loss on investments, net of tax of $0           (43)
    Total other comprehensive loss           (43)
    Comprehensive loss $(21,702) $(35,293) $(53,819) $(73,751)

     



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    Christopher Taylor
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    T: 617-949-4220
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    • Lonza to acquire and operate Codiak's Lexington, MA (US) facility and become the strategic manufacturing partner for Codiak's pipeline
    • Lonza and Codiak to establish a Center of Excellence focused on exosome manufacturing and characterization technologies
    • Lonza to gain access to the worldwide, exclusive and sub-licensable rights of Codiak's high-throughput exosome manufacturing technology
    • Codiak to receive approximately $65 million of in-kind manufacturing services for its clinical-stage programs and retain core exosome engineering and loading expertise

    BASEL, Switzerland and CAMBRIDGE, Mass., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, announced today the acquisition…

    • Lonza to acquire and operate Codiak's Lexington, MA (US) facility and become the strategic manufacturing partner for Codiak's pipeline
    • Lonza and Codiak to establish a Center of Excellence focused on exosome manufacturing and characterization technologies
    • Lonza to gain access to the worldwide, exclusive and sub-licensable rights of Codiak's high-throughput exosome manufacturing technology
    • Codiak to receive approximately $65 million of in-kind manufacturing services for its clinical-stage programs and retain core exosome engineering and loading expertise

    BASEL, Switzerland and CAMBRIDGE, Mass., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, announced today the acquisition of an exosome manufacturing facility located in Lexington, Massachusetts (US) from Codiak BioSciences (NASDAQ:CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics.

    Codiak will retain its pipeline of therapeutic candidates as well as its exosome engineering and drug-loading technologies. Codiak will receive as part of the deal approximately $65 million of cGMP manufacturing services in kind. Lonza will gain worldwide access and sub-licensable rights to Codiak's high-throughput perfusion-based cGMP process for exosome manufacturing.

    The companies will establish a Center of Excellence for the development of exosome manufacturing technologies. The Center of Excellence will leverage the strengths of both companies to advance developments in exosome production, purification and analytics while providing Lonza customers with exosome assay and process development, analytics and manufacturing services.

    Alberto Santagostino, SVP, Head of Cell and Gene Technologies at Lonza, commented: "We are excited about the collaboration we have established with Codiak BioSciences. Exosomes are emerging as a new modality for advanced therapies and could become the next frontier in biotherapeutics. Our collaboration with Codiak, one of the most advanced companies in this modality, is consistent with our strategy to advance this technology and will drive the advancement of the whole industry. We are committed to providing our capabilities to Codiak, alongside other customers in the exosome space."

    Doug Williams, PhD, CEO, Codiak BioSciences, added: "Creating an exosome manufacturing Center of Excellence with Lonza, a leading global contract development manufacturing organization, accelerates productivity of our manufacturing platform and facilitates realization of its full potential by leveraging Lonza capabilities. Importantly for Codiak, this collaboration solidifies our capacity for expanded late-stage clinical and eventually commercial manufacturing as we advance our growing clinical pipeline. We are proud Lonza recognized Codiak's pioneering work in the manufacture of engineered exosomes and look forward to our Center of Excellence helping to set new standards for the field."

    Exosomes are nano-sized membrane vesicles secreted by many cell types, which play a role in cell-to-cell communication. They represent clinically valuable tools for various applications, ranging from early detection, diagnosis, prognosis and targeted treatments. Further development of the exosome platform also has the potential to make cell and gene therapies available and commercially viable for large patient populations.

    While the development of exosomes is still at an early stage, exosome-related technologies have been progressing rapidly in the past years, with many developers working to demonstrate the efficacy and the potential of exosome-based therapies in pre-clinical or early clinical stages. Codiak has already advanced two engineered exosome therapeutic candidates into clinical studies in patients, with an IND filing planned for a third candidate in the fourth quarter of 2021.

    The investment in this emerging area reflects Lonza's strategy to differentiate through innovation. From the development of the exosome modality to the industrial production of mRNA vaccines and supporting the manufacture of live biotherapeutics, Lonza operates at the cutting edge of manufacturing technology to help customers deliver innovative new therapies to patients worldwide.

    To learn more about Lonza's exosome-related services, visit: https://pharma.lonza.com/technologies-products/exosomes

    About Lonza

    Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare sector.

    Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 15,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 2.5 billion with a CORE EBITDA of CHF 847 million in H1 2021. Find out more at www.lonza.com.

    Follow @Lonza on LinkedIn

    Follow @LonzaGroup on Twitter

    About Codiak BioSciences

    Codiak is a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx™ Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.

    Additional Information and Disclaimer

    Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

    Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise re-quired by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

    Forward-Looking Statements (Codiak)

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of the Company's engEx Platform, engEx product candidates and engineered exosomes generally, including future development plans, regulatory filings, data releases and timing with respect thereto. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Codiak's Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak's subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.



    Lonza Contact Details
    
    Victoria Morgan
    Head of External Communications
    Lonza Group Ltd
    Tel +41 61 316 2283
    
    
    Dirk Oehlers
    Investor Relations
    Lonza Group Ltd
    Tel +41 61 316 8540
    
    
    Codiak Contact Details
    
    Christopher Taylor
    VP, Investor Relations and Corporate Communications
    Tel +1 617-949-4220
    
    
    Lindy Devereux
    Scient PR
    Tel +1 646-515-5730
    

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  4. CAMBRIDGE, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced that three posters featuring preclinical data from its engEx™ Platform programs will be presented during the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021), which is being held virtually and in person in Washington, D.C. from November 10-14, 2021.

    In addition, Codiak's Chief Scientific Officer, Sriram Sathyanarayanan, Ph.D., will co-chair a session entitled "Exosomes and Cellular Engineering" and present on the company's approach to developing engineered exosome therapeutics…

    CAMBRIDGE, Mass., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced that three posters featuring preclinical data from its engEx™ Platform programs will be presented during the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021), which is being held virtually and in person in Washington, D.C. from November 10-14, 2021.

    In addition, Codiak's Chief Scientific Officer, Sriram Sathyanarayanan, Ph.D., will co-chair a session entitled "Exosomes and Cellular Engineering" and present on the company's approach to developing engineered exosome therapeutics and the opportunity to overcome historical challenges of other modalities in immuno-oncology.   

    "At SITC this year, we will present for the first time preclinical data on our exosome therapeutic candidates in two new settings, including in leptomeningeal disease with exoSTING and in combination therapy with exoSTING and exoIL-12 in solid tumors," said Dr. Sathyanarayanan. "In addition, we will share new data in hepatocellular carcinoma models with our next clinical candidate, exoASO-STAT6, for which we expect to file an IND by the end of the year. Taken together, these data point to new potential therapeutic applications for engineered exosomes and the flexibility and broad potential of our platform to create new classes of molecular medicines."

    Poster Presentations:

    exoSTING™ Demonstrates Potent Anti-Tumor Activity in a Mouse Model of Leptomeningeal Disease

    Abstract number: 761

    Date: Friday, November 12, 2021

    Exosome-Mediated Reprogramming of Tumor-Associated Macrophages by exoASO-STAT6 for the Treatment of Hepatocellular Carcinoma (HCC)

    Abstract number: 842

    Date: Saturday, November 13, 2021

    Combination Therapy of exoSTING, exoIL-12 Activates Systemic Anti-Tumor Immunity

    Abstract number: 572

    Date: Saturday, November 13, 2021

    Abstracts will be made available by SITC on November 9, 2021 at 8:00 a.m. ET and posters will be available via the conference platform beginning November 12, 2021 at 7:00 a.m. ET.

    Concurrent Session:

    Exosomes and Cellular Engineering (#216)

    Title: Developing Engineered Exosome Based Therapeutics for Immuno-Oncology

    Date/Time: Saturday, November 13, 2021, 5:10-6:25 p.m. ET

    About the engEx™ Platform

    Codiak's proprietary engEx Platform is designed to enable the development of engineered exosome therapeutics for a wide spectrum of diseases and to manufacture them reproducibly and at scale to pharmaceutical standards. By leveraging the inherent biology, function and tolerability profile of exosomes, Codiak is developing engEx exosomes designed to carry and protect potent drug molecules, provide selective delivery and elicit the desired pharmacology at the desired tissue and cellular sites. Through its engEx Platform, Codiak seeks to direct tropism and distribution by engineering exosomes to carry on their surface specific targeting drug moieties, such as proteins, antibodies/fragments, and peptides, individually or in combination. Codiak scientists have identified two exosomal proteins that serve as surface and luminal scaffolds. By engineering the exosome surface or lumen and optimizing the route of administration, Codiak aims to deliver engEx exosomes to the desired cell and tissue to more selectively engage the drug target, potentially enhancing the therapeutic index by improving potency and reducing toxicity.

    About Codiak BioSciences

    Codiak is a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoIL-12 and exoASO-STAT6, including future development plans and regulatory filings and timing with respect thereto. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Codiak's Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak's subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.



    Investor Contact:
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    VP, Investor Relations and Corporate Communications
    T: 617-949-4220
    E: 
    
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    Scient PR
    T: 646-515-5730
    E: 

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