Board Change • Nov 16
High number of new directors Member of Scientific Advisory Board Raghu Kalluri was the last director to join the board, commencing their role in 2022. Major Estimate Revision • Nov 10
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$2.06 to -US$1.68 per share. Revenue forecast steady at US$27.1m. Biotechs industry in the US expected to see average net income decline 80% next year. Consensus price target of US$5.80 unchanged from last update. Share price fell 16% to US$0.76 over the past week. Reported Earnings • Nov 05
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: US$0.77 loss per share (improved from US$0.97 loss in 3Q 2021). Revenue: US$522.0k (down 55% from 3Q 2021). Net loss: US$19.3m (loss narrowed 11% from 3Q 2021). Revenue missed analyst estimates by 11%. Earnings per share (EPS) exceeded analyst estimates by 3.8%. Revenue is expected to decline by 74% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Price Target Changed • Sep 05
Price target decreased to US$6.00 Down from US$8.00, the current price target is an average from 3 analysts. New target price is 249% above last closing price of US$1.72. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$1.95 next year compared to a net loss per share of US$1.70 last year. Price Target Changed • Aug 06
Price target decreased to US$8.00 Down from US$11.33, the current price target is an average from 2 analysts. New target price is 235% above last closing price of US$2.39. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$2.08 next year compared to a net loss per share of US$1.70 last year. Reported Earnings • Aug 05
Second quarter 2022 earnings released: US$0.30 loss per share (vs US$0.99 loss in 2Q 2021) Second quarter 2022 results: US$0.30 loss per share (up from US$0.99 loss in 2Q 2021). Revenue: US$13.1m (up US$12.3m from 2Q 2021). Net loss: US$6.78m (loss narrowed 69% from 2Q 2021). Over the next year, revenue is expected to shrink by 76% compared to a 46% growth forecast for the industry in the US. Board Change • Aug 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Raghu Kalluri was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Jul 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board Raghu Kalluri was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Major Estimate Revision • May 12
Consensus revenue estimates increase by 64% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$8.76m to US$14.3m. Forecast losses expected to reduce from -US$2.57 to -US$1.93 per share. Biotechs industry in the US expected to see average net income decline 44% next year. Consensus price target down from US$29.00 to US$26.67. Share price fell 26% to US$2.51 over the past week. Price Target Changed • May 07
Price target decreased to US$26.67 Down from US$29.00, the current price target is an average from 2 analysts. New target price is 823% above last closing price of US$2.89. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$1.58 next year compared to a net loss per share of US$1.70 last year. Reported Earnings • May 06
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: US$0.36 loss per share (up from US$0.51 loss in 1Q 2021). Revenue: US$12.7m (down 3.7% from 1Q 2021). Net loss: US$8.03m (loss narrowed 22% from 1Q 2021). Revenue exceeded analyst estimates by 102%. Earnings per share (EPS) also surpassed analyst estimates by 55%. Over the next year, revenue is expected to shrink by 67% compared to a 41% growth forecast for the industry in the US. Board Change • Mar 29
High number of new directors Member of Scientific Advisory Board & Consultant Benny Sorensen was the last director to join the board, commencing their role in 2021. Major Estimate Revision • Mar 17
Consensus revenue estimates increase by 41% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$6.22m to US$8.76m. Forecast losses expected to reduce from -US$2.65 to -US$2.62 per share. Biotechs industry in the US expected to see average net income decline 42% next year. Consensus price target broadly unchanged at US$29.00. Share price rose 12% to US$5.22 over the past week. Reported Earnings • Mar 11
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$1.71 loss per share (up from US$16.19 loss in FY 2020). Revenue: US$22.9m (up US$20.0m from FY 2020). Net loss: US$37.2m (loss narrowed 64% from FY 2020). Revenue exceeded analyst estimates by 37%. Earnings per share (EPS) missed analyst estimates by 50%. Over the next year, revenue is expected to shrink by 73% compared to a 60% growth forecast for the pharmaceuticals industry in the US. Price Target Changed • Feb 23
Price target decreased to US$29.33 Down from US$35.00, the current price target is an average from 2 analysts. New target price is 506% above last closing price of US$4.84. Stock is down 73% over the past year. The company is forecast to post a net loss per share of US$3.42 next year compared to a net loss per share of US$16.18 last year. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.97 loss per share (vs US$12.83 loss in 3Q 2020) The company reported a solid third quarter result with reduced losses, improved revenues and improved control over expenses. Third quarter 2021 results: Revenue: US$1.16m (up 21% from 3Q 2020). Net loss: US$21.7m (loss narrowed 44% from 3Q 2020). Price Target Changed • Oct 29
Price target increased to US$39.50 Up from US$35.00, the current price target is an average from 3 analysts. New target price is 184% above last closing price of US$13.90. Stock is up 57% over the past year. The company is forecast to post a net loss per share of US$3.43 next year compared to a net loss per share of US$16.18 last year. Reported Earnings • Aug 08
Second quarter 2021 earnings released: US$0.99 loss per share (vs US$6.44 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$890.0k (up 376% from 2Q 2020). Net loss: US$21.8m (loss widened 13% from 2Q 2020). Board Change • Aug 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Member of Scientific Advisory Board & Consultant Benny Sorensen was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions Derivative • Jun 10
Insider notifies of intention to sell stock Benny Sorensen intends to sell 21k shares in the next 90 days after lodging an Intent To Sell Form on the 7th of June. If the sale is conducted around the recent share price of US$24.28, it would amount to US$519k. As of today, Benny currently holds no shares directly (This sale likely refers to shares that have not yet been received). There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • May 09
First quarter 2021 earnings released: US$0.51 loss per share (vs US$7.54 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: US$13.2m (up US$13.0m from 1Q 2020). Net loss: US$10.3m (loss narrowed 54% from 1Q 2020). Major Estimate Revision • Mar 24
Consensus EPS estimates fall to -US$4.00 The consensus outlook for earnings per share (EPS) in 2021 has deteriorated. 2021 revenue forecast decreased from US$4.07m to US$3.79m. Losses expected to increase from -US$2.97 to -US$4.00. Biotechs industry in the US expected to see average net income growth of 4.2% next year. Consensus price target up from US$35.00 to US$36.67. Share price fell 3.4% to US$16.64 over the past week. Reported Earnings • Mar 19
Full year 2020 earnings released: US$16.19 loss per share (vs US$30.66 loss in FY 2019) Full year 2020 results: Net loss: US$102.5m (loss widened 12% from FY 2019). Aankondiging • Mar 10
Codiak BioSciences, Inc. Announces Resignation of Ajay Verma as Executive Vice President, Research and Experimental Medicine On March 5, 2021, Ajay Verma, M.D., Ph.D., the Executive Vice President, Research and Experimental Medicine of Codiak BioSciences, Inc., separated from the company, effective as of March 5, 2021. Executive Departure • Mar 09
Executive Vice President of Research & Experimental Medicine Ajay Verma has left the company On the 5th of March, Ajay Verma's tenure as Executive Vice President of Research & Experimental Medicine ended after 1.6 years in the role. We don't have any record of a personal shareholding under Ajay's name. A total of 2 executives have left over the last 12 months. Is New 90 Day High Low • Mar 06
New 90-day low: US$15.14 The company is down 13% from its price of US$17.45 on 04 December 2020. The American market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Aankondiging • Feb 13
Codiak BioSciences, Inc. has completed a Follow-on Equity Offering in the amount of $57.75 million. Codiak BioSciences, Inc. has completed a Follow-on Equity Offering in the amount of $57.75 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,750,000
Price\Range: $21 Aankondiging • Feb 05
Codiak Reports Additional Positive Phase 1 Results for exoIL-12™ Confirming Local Pharmacology and Dose Selection for Safety and Efficacy Trial in Early-Stage Cutaneous T Cell Lymphoma (CTCL) Patients Codiak BioSciences, Inc. announced pharmacodynamic (PD) activity results from the healthy volunteer portion of its randomized, placebo-controlled, double-blind Phase 1 trial of the company's clinical candidate, exoIL-12. Analyses of skin punch biopsies bordering the subcutaneous injection site of exoIL-12 revealed local retention of immunologically detectable IL-12 at the injection site, and localized pharmacological activity as measured by levels of the T cell attractant chemokine, IP-10, in the skin. IL-12 was not detected in plasma at any dose of exoIL-12 tested and plasma IP-10 was only detectable at the highest, 12 μg dose. Results confirmed the desired localization and retention of IL-12 at the injection site for at least 24 hours, as well as prolonged IP-10 production for 8-15 days depending upon dose. Aankondiging • Jan 28
Codiak BioSciences, Inc. Announces Resignation of Eric S. Lander from the Board, as a Class II Director, and All Committees On January 20, 2021, Eric S. Lander, Ph.D., a member of the Board of Directors of Codiak BioSciences, Inc., resigned from the Board, as a Class II director, and all committees thereof, effective January 25, 2021. Dr. Lander's resignation is due to his appointment to a role in the Biden-Harris Administration. Aankondiging • Jan 24
Codiak’s Versatile engEx™ Platform for Engineered Exosomes Published in the Journal Molecular Therapy Codiak BioSciences, Inc. announced the advance online publication of a new manuscript. The paper, entitled versatile platform for generating engineered extracellular vesicles with defined therapeutic properties by Dooley et al, will appear in an upcoming print issue of Molecular Therapy, the journal of the American Society of Gene and Cell Therapy. The publication describes the identification and characterization of two novel exosome-associated proteins, PTGFRN and BASP1, that enable Codiaks proprietary engEx Platform and facilitate precise design and engineering of exosomes for potential therapeutic purposes. PTGFRN and BASP1 are highly abundant, naturally-occurring proteins that, through Codiak's research, have been found to enable high-density exosome surface display and luminal loading of a wide range of macromolecules that can be directed to specific target cells of interest. In preclinical models, the use of PTGFRN and BASP1 to display biologically active molecules on the surface of or inside exosomes, respectively, resulted in uniform incorporation and increased potency, suggesting the potential utility of these engineered exosomes in a wide variety of therapeutic settings. These two proteins can also be used in combination, which further broadens the utility and modular approach to designing engineered exosomes for targeted delivery of numerous drug payloads to
specific cells. Aankondiging • Dec 31
Codiak BioSciences, Inc. Reports Positive Initial Phase 1 Results for Exoil-12 ™ Demonstrating Tolerability and Absence of Systemic Il-12 Exposure in Healthy Volunteers Codiak BioSciences, Inc. announced that the primary objectives were met in the initial part of its Phase 1 trial, which evaluated a single ascending dose of exoIL-12 in healthy volunteers. In this randomized, placebo controlled, double-blind study, exoIL-12 demonstrated a favorable safety and tolerability profile, with no local or systemic treatment-related adverse events and no detectable systemic exposure of IL-12. exoIL-12 is the first engineered exosome therapeutic candidate to be evaluated in humans and one of two Codiak programs currently in clinical development. exoIL-12 was engineered using the company’s proprietary engEx ™ Platform and designed to display functional IL-12 on the exosome surface using the exosomal protein, PTGFRN, as a scaffold, the capability of which was identified by Codiak scientists. IL-12 is a potent anti-tumor cytokine, but prior clinical development conducted by others1 of recombinant IL-12 (rIL-12)-based therapies has generally been hindered by significant safety and tolerability concerns. To overcome these limitations, exoIL-12 was designed to facilitate dose control of IL-12 and limit systemic exposure and associated toxicity by localizing IL-12 in the tumor microenvironment (TME) in order to potentially expand the therapeutic index. A total of five cohorts each with five subjects, randomized 3:2 active drug to placebo, were enrolled and dosed in the first part of the Phase 1 study. Each cohort received a subcutaneously administered single ascending dose of exoIL-12: 0.3 µg, 1.0 µg, 3.0 µg, 6.0 µg or 12.0 µg, respectively. No treatment-related adverse events were observed throughout 10 days of follow-up. In particular, no chills, fever, fatigue, dizziness, myalgia, headache or back pain were reported. These symptoms have been observed in previous clinical studies of subcutaneously administered rIL-12 at comparable doses (ranging from 2 to 12 µg)1 to those used in Codiak’s study of exoIL-12. Plasma pharmacokinetic (PK) measurements of subjects that received exoIL-12 showed no systemic exposure with levels of IL-12 below the limit of quantification. In contrast, previous rIL-12 clinical studies showed dose-dependent systemic exposure with dosages of 5 and 12 µg resulting in Cmax plasma levels of approximately 15 to 45 pg/ml within 6 to 12 hours after dosing. Codiak’s analyses of pharmacodynamic (PD) data from the healthy volunteer portion of the exoIL-12 trial, including skin IL-12 levels and IL-12 signaling from skin punch biopsies collected before and at 24 hours, Day 8 and Day 15 after subcutaneous administration around the injection site, are ongoing and are expected to be available in early First Quarter 2021. The company intends to use these results to identify an optimal pharmacological dose to carry forward into the second part of the trial, which is on track to begin in First Quarter 2021 and will evaluate repeat dosing of exoIL-12 in patients with early-stage cutaneous T cell lymphoma (CTCL). Aankondiging • Nov 11
Codiak BioSciences, Inc. Presents Preclinical Data at SITC 2020 Demonstrating Potential of engEx™ Engineered Exosomes to Stimulate Targeted, Integrated Anti-Tumor Immunity Codiak BioSciences, Inc. announced that preclinical data from programs using its engEx™ Platform are being presented this week at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). Results from multiple studies highlight the potential of Codiak’s precision engineered exosomes to direct pharmacological payloads to specific cells and to achieve enhanced immune mediated anti-tumor activity with an expanded safety margin. Exosomes are naturally occurring, extracellular vesicles that have evolved as an intercellular messenger system to protect and deliver functional macromolecules between cells. Utilizing its engEx Platform, Codiak can engineer exosomes with distinct properties, load them with various types of therapeutic molecules and alter tropism so they reach specific cellular targets. Codiak is developing exosome therapeutic candidates to target multiple pathways throughout the body to treat various forms of cancer, neurological diseases, and infectious diseases. The company initiated clinical trials in September 2020 for two engineered exosome candidates, exoIL-12 and exoSTING™, for the treatment of lymphoid and solid tumors. Tumor-Retained Pharmacology and Superior In Vivo Efficacy of exoIL-12 Widens the Therapeutic Window exoIL-12 is a novel exosome therapeutic candidate engineered to display active IL-12 on the surface of the exosome. exoIL-12 facilitates potent local pharmacology at the injection site with precisely quantified doses with minimal systemic exposure. The current studies extend observations from previous presentations demonstrating tumor retention and increased tumor growth inhibition across multiple mouse models. Additionally, these data demonstrate significant remodeling of the tumor microenvironment and confirm tissue-retained pharmacology in non-human primate models, thereby widening the therapeutic window for this potent cytokine. Highlights from the data presented at SITC 2020 include: exoIL-12 showed 15-fold improved retention at the injection site and demonstrated four-fold prolonged and improved interferon gamma (IFN?) production as compared to recombinant IL-12 (rIL-12). exoIL-12 was 100 fold more potent in tumor growth inhibition than rIL-12. Complete responses were observed in 63% of mice treated with exoIL-12 compared to 0% in mice treated with an equivalent dose of rIL-12. exoIL-12 showed dramatic change in the tumor microenvironment as evidenced by ~8-fold increase in cytotoxic T-cell infiltration and ~150-fold increase in M1 macrophage recruitment. In the non-human primates, exoIL-12 demonstrated tissue-localized pharmacology, local induction of IFNg, and lack of systemic exposure. Engineered Exosomes Allow for Targeting of Multiple Immune Cell Types. 