Announcement • Aug 19
Motion for Asset Sale Approved for Genocea Biosciences, Inc. The US Bankruptcy Court gave an order approving the sale of the certain assets of Genocea Biosciences, Inc. on August 17, 2022. The debtor has been authorized to sell its certain assets to Commercialization of Regenerative Medicine, for a purchase price of $0.63 million in cash. The debtor’s assets include purchased equipment. Announcement • Aug 11
Bidding Procedure Approved for Genocea Biosciences, Inc. The US Bankruptcy Court gave an order approving the bidding procedures relating to the sale of certain assets of Genocea Biosciences, Inc. on August 9, 2022. The Court approved the asset purchase agreement between the debtor and Harpy Holdings, LLC for a purchase price of $2 million in cash, pursuant to the asset purchase agreement, dated August 2, 2022, for the sale of certain assets. The debtor’s assets include intellectual property related to the ATLAS platform, including a portfolio of patents and trademarks, research and clinical trial data, research materials, and software URLs and related equipment. The buyer shall make a cash deposit of $0.20 million to the escrow agent and the balance will be paid on closing. To qualify as a qualified bidder, interested parties should submit their bids by September 16, 2022, along with good-faith deposit in the amount of $0.02 million. The buyer would be entitled to a break-up fee and expense reimbursement of $0.10 million in case of termination of the asset purchase agreement. The sale hearing is scheduled for September 21, 2022. Announcement • Aug 06
Motion for Asset Sale Filed by Genocea Biosciences, Inc. Genocea Biosciences, Inc. filed a motion in the US Bankruptcy Court for the sale of its certain assets on August 4, 2022. The debtor seeks the Court’s approval for the sale of its certain assets to Harpy Holdings, LLC for a purchase price of $2 million in cash, pursuant to the asset purchase agreement, dated August 2, 2022. The debtor’s assets include intellectual property related to the ATLAS platform, including a portfolio of patents and trademarks, research and clinical trial data, research materials, and software URLs and related equipment. The buyer shall make a cash deposit of $0.20 million to the escrow agent and the balance will be paid on closing. To qualify as a qualified bidder, interested parties should submit their bids by fifth to last business day prior to the scheduled date of the sale hearing, along with good-faith deposit in the amount of $0.02 million. The buyer would be entitled to a break-up fee and expense reimbursement of $0.10 million in case of termination of the asset purchase agreement. The sale hearing will be held no later than September 23, 2022. The buyer is represented by Irving E. Walker of Cole Schotz P.C. as its legal advisor and the seller is represented by James M. Wilton of Ropes & Gray LLP as its legal advisor. Announcement • Jul 06
Genocea Biosciences, Inc. Filed for Bankruptcy Genocea Biosciences, Inc. filed a voluntary petition for reorganization under Chapter 11 in the US Bankruptcy Court for the District of Massachusetts on July 5, 2022. The debtor listed both its assets and liabilities in the range of $1 million to $10 million. The debtor is represented by Andrew G. Lizotte of Murphy & King, P.C. and Ropes & Gray LLP as its legal counsel. The debtor also hired Rock Creek Capital Advisors, LLC as financial advisor and OMNI Management Group, LLC as noticing agent. Announcement • May 26
Genocea Biosciences to Delist from Nasdaq Genocea Biosciences, Inc. announced that its Board of Directors voted to wind down the Company’s ongoing operations and terminate the Company’s remaining employees except those deemed necessary to complete an orderly wind down. On May 23, 2022, the Company delivered formal notice to The Nasdaq Stock Market, Inc. of its intent to voluntarily delist its Common Stock from the Nasdaq Capital Market in connection with the wind down of its operations. The Company plans to file a Form 25 with the Securities and Exchange Commission on or about June 2, 2022, to effect the voluntary delisting of the Common Stock under Section 12(b) of the Securities Exchange Act of 1934, as amended. Also, on May 23, 2022, the Company received a letter from the Nasdaq Listing Qualifications department of Nasdaq notifying the Company that it was not in compliance with the requirement of Nasdaq Marketplace Rule 5450(a)(1) for continued inclusion on The Nasdaq Capital Market as a result of the closing bid price for the Company’s common stock being below $1.00 for 30 consecutive business days. Announcement • Apr 09
Genocea Biosciences, Inc. Presents Encouraging Initial Data from GEN-011 Phase 1/2a Trial at AACR 2022 Genocea Biosciences, Inc. presented clinical, preclinical, and manufacturing data at the American Association for Cancer Research (AACR) Annual Meeting 2022 beginning April 8, 2022 in New Orleans and virtually. The presentations include promising initial data from the TiTAN™ clinical trial for the neoantigen-targeted peripheral T cell (NPT) therapy product candidate GEN-011, results demonstrating successful production of GEN-011 using Genocea’s PLANET™ manufacturing process, and new preclinical data on Inhibigens™, antigens of suppressive immune responses uniquely identifiable by Genocea’s ATLAS™ platform. The Phase 1/2a TiTAN trial investigates the safety, tolerability, T cell persistence and proliferation, and clinical activity of GEN-011 in patients with refractory solid tumors. The study includes two dosing cohorts. Cohort A patients (n=2) received a lower intensity regimen without lymphodepletion with fractional GEN-011 doses monthly, and with post-infusion intermediate dose interleukin-2 (IL-2) (125K IU/kg daily s.c.). In Cohort B, patients (n=3) received GEN-011 as a single infusion after lymphodepletion, followed by IL-2. This Cohort includes one of three escalating lymphodepletion and IL-2 dose regimens, and patients have not yet been dosed at the high regimen. The early results presented at AACR show anti-tumor activity despite the lower intensity regimens and heavily pretreated tumors. Stable disease was seen at the initial Day 57 scan in four of the five patients. While all patients had progressive disease (PD) at their Day 113 scan, three of the five experienced clear biologic changes after infusion. These included palpable improvement in peripheral nodal disease and resolution of severe neuropathy causing arm paralysis and pain in patients with refractory SCCHN. A patient with metastatic non-small cell lung cancer (NSCLC) experienced a 10% reduction in tumor diameters (approx. 30% reduction in volume), also with resolution of tumor associated cough. The potential for drug product proliferation and persistence for months is supported by translational assays, and clinical activity is associated with declines in detectable circulating tumor DNA (ctDNA) after treatment in some patients. Genocea has had a 100% success rate in manufacturing GEN-011 through its PLANET process to date. Of the 17 patient samples entering PLANET, 100% have either successfully yielded a released drug product (14) or are continuing in process (3). Significantly, as a result of continuous process improvements, the next six patients will be dosed with drug products that have a median two-fold increase in cell dose and greater neoantigen specificity and potency. Additional data presented at AACR highlights ongoing work characterizing inhibitory antigens, or Inhibigens - putatively pro-tumor antigens that are uniquely identifiable by ATLAS and present in nearly every cancer patient profiled by Genocea. With the benefit of ATLAS, Genocea excludes T cells to Inhibigens from GEN-011. A preclinical poster presented at the meeting demonstrates how detrimental these Inhibigens are to the efficacy of cancer therapeutics in mouse models of melanoma and pancreatic cancer. Reported Earnings • Mar 12
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.48 loss per share (up from US$0.98 loss in FY 2020). Net loss: US$33.2m (loss narrowed 24% from FY 2020). Products in clinical trials Phase I: 2 Revenue was in line with analyst estimates. Over the next year, revenue is expected to shrink by 100% compared to a 76% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings. Announcement • Jan 06
Genocea Biosciences Provides Corporate Update Genocea Biosciences, Inc. reported significant progress in the Phase 1/2a TiTAN clinical trial for its lead program GEN-011, a neoantigen-targeted peripheral T cell (NPT) therapy candidate. GEN-011 is comprised only of CD8+ and CD4+ T cells, extracted from the patient’s peripheral blood, specific for ATLAS-prioritized neoantigens. GEN-011 has the potential to be differentiated from other cell therapies because of the breadth of surface-presented neoantigens it targets and the ease of manufacturing tumor-relevant T cells extracted from readily accessible peripheral blood. Patients receive either GEN-011 in multiple fractional doses without lymphodepletion and with intermediate doses of IL-2, or as a single dose after lymphodepletion and with intermediate or high doses of IL-2. ATLAS performance: The GEN-011 NPTs are specific for neoantigens prioritized using ATLAS, Genocea’s proprietary neoantigen discovery platform. To date, Genocea has completed screening 19 patient samples with ATLAS in the TiTAN trial. On average in these samples, ATLAS has prioritized 12 neoantigens (range 0-43) and identified 14 Inhibigens (range 1-55) per patient. T cells specific for only the prioritized neoantigens (and therefore not the Inhibigens) are expanded in the PLANET™ process. PLANET performance: These T cells are grown in PLANET, Genocea’s robust and rapidly scalable cell expansion process. Of the 16 patient samples entering the PLANET manufacturing process, 100% have either successfully yielded a released drug product (10) or are in process (6). TiTAN update: Of the 10 manufactured GEN-011 drug products, five have been administered to patients across both the multidose and single dose cohorts, with the remaining five available for dosing upon patient need. Genocea expects to have initial data from the first five patients later this quarter or early Second Quarter 2022. With eight sites currently accruing patients, Genocea expects to continuously enroll and dose patients throughout the year. Board Change • Dec 06
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. 3 highly experienced directors. Independent Director Jennifer Herron was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Oct 29
Third quarter 2021 earnings released: US$0.052 loss per share (vs US$0.082 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$3.62m (loss narrowed 21% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings. Announcement • Jul 15
Genocea Biosciences, Inc. Doses First Patient in Phase 1/2a TiTAN Clinical Trial for GEN-011 Neoantigen-Targeted T cell Therapy Genocea Biosciences, Inc. announced the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells (“NPTs”). GEN-011: GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response. GEN-011 TiTAN clinical trial: TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated lower dose regimen of GEN-011 without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected in late fourth quarter of 2021 or first quarter of 2022. Announcement • Jun 05
Genocea Biosciences, Inc. Presents Promising Long-Term Results from Gen-009 Neoantigen Vaccine Phase 1 Trial At Asco 2021 Genocea Biosciences, Inc. presents updated immunogenicity and clinical response data from the GEN-009 Phase 1 trial that continue to validate the company’s unique and differentiated approach to identifying clinically meaningful immunotherapy targets through the proprietary ATLAS selection process. Long-term results demonstrate that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part A of the study, designed to measure safety and immunogenicity only, eight patients with no measurable disease were vaccinated with GEN-009 as a monotherapy. Six of the eight patients continue without recurrence with a median follow up of 25 months post start of the vaccination. Notably, as previously reported, GEN-009 elicited T cell immune responses to 99% of the ATLAS-selected neoantigens, the seen across neoantigen vaccine programs. In Part B, patients were enrolled at the initiation of a PD-1 checkpoint inhibitor (CPI)-based standard of care (SOC) regimen for advanced or metastatic disease; patients who were controlled on SOC and did not require alternate therapy are labeled CPI-sensitive, patients who required alternate therapy before vaccination are labeled CPI-refractory. Of the nine CPI-sensitive patients, the latest data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses (PRs) and one complete response (CR). This is an increase from the two PRs and one CR previously reported at SITC 2020. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. GEN-009 has been well tolerated with only mild adverse events associated with the vaccine adjuvant. Expanded immunogenicity data from Part B of the study revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response. CPI-sensitive subjects had a greater number of neoantigens identified with ATLAS at baseline compared with patients in the CPI-refractory cohort, and also had evidence of epitope spread for CD8+ T cells post-dosing. Additionally, the magnitude of CD4+ T cell responses were greater for the CPI-refractory than CPI-sensitive subjects, despite a reduced proportion of peptides to which CD4+ T cell responses were measured, suggesting that the breadth and not the magnitude of response could be associated with favorable outcomes. Executive Departure • Apr 16
Independent Director has left the company On the 12th of April, Ronald H. Cooper's tenure as Independent Director ended after 4.8 years in the role. We don't have any record of a personal shareholding under Ronald H.'s name. A total of 2 executives have left over the last 12 months. Is New 90 Day High Low • Feb 15
New 90-day high: €2.98 The company is up 71% from its price of €1.74 on 18 November 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 16% over the same period. Announcement • Feb 12
Genocea Biosciences, Inc. Appoints Raymond D. Stapleton, Jr. as Executive Vice President of Pharmaceutical Sciences and Manufacturing Genocea Biosciences, Inc. appointed Raymond D. Stapleton, Jr., Ph.D. as Executive Vice President of Pharmaceutical Sciences and Manufacturing. Ray brings 20+ years of industry experience having led technical, quality and manufacturing operations at commercial and clinical stage biopharmaceutical companies. Analyst Estimate Surprise Post Earnings • Feb 12
Revenue misses expectations Revenue missed analyst estimates by 2.9%. Over the next year, revenue is expected to shrink by 67% compared to a 79% growth forecast for the Biotechs industry in Germany. Is New 90 Day High Low • Jan 14
New 90-day high: €2.46 The company is up 9.0% from its price of €2.26 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is up 4.0% over the same period. Announcement • Nov 11
Genocea Biosciences, Inc. Presents Positive GEN-009 Clinical Results, Update on GEN-011 Program and New InhibigenTM Mechanism of Action Data at Virtual SITC 2020 Genocea Biosciences, Inc. presented four posters that collectively validate the company’s unique and differentiated approach to identifying clinically meaningful immunotherapy targets at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting taking place virtually November 9 – 14. In follow up to data shared at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the company shared expanded clinical and immunogenicity findings from Part B of its ongoing GEN-009 Phase 1/2a trial, which evaluates GEN-009, the company’s neoantigen vaccine, in combination with PD-1 inhibitors in advanced cancers. Posters 390 and 413 outline the clinical and immune responses elicited by GEN-009 in 16 checkpoint inhibitor (CPI) therapy sensitive and resistant patients. Poster 413 was a highly scored abstract selected for a Poster Walk. Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Within the CPI-resistant population, five of seven patients appear to have stabilized disease lasting up to seven months. GEN-009 elicited strong anti-tumor immune responses with both CD4+ and CD8+ T cell responses observed at day 50 post-vaccination and with peak ex vivo responses occurring Day 92. Early data from two patients tested so far show a complete absence of circulating tumor DNA by day 50, which is consistent with a vaccine clinical effect. There was also emerging evidence of epitope spreading in patients who successfully responded to therapy. GEN-009 was safe and well tolerated. Announcement • Sep 23
Genocea Announces FDA Acceptance of GEN-011 IND Application Genocea Biosciences, Inc. announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive T cell therapy targeting neoantigens and designed to improve upon the limitations of TIL and TCR therapies. The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity. Genocea plans to enroll up to 24 patients across several tumor types in the Phase 1/2 trial. In one cohort, patients will receive multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion. In the other cohort, patients will receive a single GEN-011 dose after lymphodepletion and a high dose of IL-2. Announcement • Jul 23
Genocea Biosciences, Inc. announced that it expects to receive $80 million in funding Genocea Biosciences, Inc. (NasdaqCM:GNCA) announced a private placement for an aggregate gross proceeds of $80 million led by leading United States public investment fund specializing in life sciences on July 22, 2020. The transaction will also include participation from certain existing and new investors. The company will issue 21,400,000 common shares and 12,200,000 pre funded warrants in the transaction. The pre funded warrants can be exercisable to purchase common shares of the company. The company will also issue warrants to purchase an additional common share for each share of common share or pre funded warrant purchased by the investor. The warrants will be exercisable in whole or part at an exercise price of $2.25 per share and will have a term of 4 years. The transaction is expected to close on or about July 24, 2020 subject to customary closing conditions. Announcement • Jul 18
Genocea Biosciences, Inc. to Report Q2, 2020 Results on Jul 23, 2020 Genocea Biosciences, Inc. announced that they will report Q2, 2020 results at 12:06 PM, GMT Standard Time on Jul 23, 2020 
