お知らせ • Nov 22
EQRx, Inc. Files Form 15 EQRx, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share. お知らせ • Nov 10
EQRx, Inc.(NasdaqGM:EQRX) dropped from NASDAQ Biotechnology Index EQRx, Inc. has been removed from NASDAQ Biotech Index . お知らせ • Aug 03
Revolution Medicines, Inc. (NasdaqGS:RVMD) entered into a definitive agreement to acquire EQRx, Inc. (NasdaqGM:EQRX) from a group of shareholders. Revolution Medicines, Inc. (NasdaqGS:RVMD) entered into a definitive agreement to acquire EQRx, Inc. (NasdaqGM:EQRX) from a group of shareholders on July 31, 2023. Under the terms of the merger agreement, Revolution Medicines will acquire EQRx in an all-stock transaction. The stock exchange ratio formula in the merger agreement uses a blended average to account for developments in Revolution Medicines’ ongoing business and potential movement in its stock price. Approximately 80% of the stock exchange ratio is based on Revolution Medicines’ public market stock price measured in close proximity to the EQRx stockholder vote and the remaining 20% of the exchange ratio is a determined price per share of Revolution Medicines’ stock as of the signing of the merger agreement. Specifically, at closing, EQRx stockholders will receive the number of shares of Revolution Medicines common stock equal to the sum of 7,692,308 Revolution Medicines shares (determined as $200 million divided by $26.00 per share) plus a number of shares equal to $870 million divided by a price that is a 6% discount to the 5-day volume-weighted average Revolution Medicines share price measured in close proximity to the stockholder vote. At the close of the transaction, one EQRx director will be designated by Revolution Medicines to serve on its board of directors. Upon completion of the transaction, EQRx shares will cease trading on the Nasdaq Global Market. Upon termination of the Merger Agreement under certain specified circumstances, including (i) the termination of the Merger Agreement by EQRx or the Company in order to enter into an alternative transaction constituting a superior proposal or (y) the termination of the Merger Agreement by the other party due to a change in recommendation of EQRx’s or the Company’s board of directors to its stockholders, EQRx or the Company may be required to pay the other party a termination fee of $25.0 million (in the case of a termination fee payable by EQRx) or $65.0 million (in the case of a termination fee payable by the Company). In addition, if the Merger Agreement is terminated due to either party’s failure to obtain the requisite stockholder vote under circumstances in which a termination fee is not payable, EQRx or the Company may be required to pay the other party an expense reimbursement of up to $10.0 million.The transaction is expected to close in November 2023, subject to satisfaction of customary closing conditions, including regulatory review, and approval by Revolution Medicines’ and EQRx’s stockholders.Guggenheim Securities, LLC is acting as Revolution Medicines’ financial advisor and Latham & Watkins LLP is serving as legal counsel. Goldman Sachs & Co. LLC is acting as lead financial advisor to EQRx. MTS Health Partners, L.P. is also acting as financial advisor to EQRx. Goodwin Procter LLP is acting as legal counsel for EQRx. New Risk • Aug 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$327m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (3.4% increase in shares outstanding). お知らせ • Dec 20
EQRx, Inc. Announces Acceptance of Marketing Authorization Application by the Uk's Medicines and Healthcare Products Regulatory Agency for Sugemalimab in Metastatic Non-Small Cell Lung Cancer EQRx, Inc. announced that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review its marketing authorization application (MAA) for sugemalimab, an anti-programmed death-ligand 1 (PD-L1) antibody, in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The MAA is primarily supported by data from the pivotal Phase 3 GEMSTONE-302 trial, conducted by EQRx's partner CStone Pharmaceuticals, that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC. In 2021, sugemalimab was granted the Innovation Passport designation in the U.K. through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations including the MHRA. The ILAP was established in early 2021 toaccelerate the development of and access to medicines in the U.K. お知らせ • Dec 03
EQRx, Inc. Announces Acceptance of Marketing Authorization Application by the European Medicines Agency for Aumolertinib in EGFR-Mutated Non-small Cell Lung Cancer EQRx, Inc. announced that the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for aumolertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in development for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations, and for adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In 2020, lung cancer was the third most diagnosed cancer in Europe and the leading cause of cancer-related mortality, accounting for one fifth of cancer deaths. Globally, it is estimated that almost a third of patients with NSCLC, which accounts for approximately 85% of all lung cancers, have EGFR mutations. The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC. This is EQRx’s second submission to a regulatory agency for aumolertinib. Aumolertinib’s MAA for use in EGFR-mutated non-small cell lung cancer is currently under review by the UK’s Medicines and Healthcare products Regulatory Agency. Board Change • Nov 16
High number of new and inexperienced directors There are 11 new directors who have joined the board in the last 3 years. The company's board is composed of: 11 new directors. 1 experienced director. No highly experienced directors. Co-Founder, Advisor, Member of Mission Advisory Board & Independent Director Sandra Horning is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Seeking Alpha • Aug 28
EQRx: Saving American Lives, Made Possible By Low Cost Chinese Drugs Summary
EQRx's goal is to make drugs affordable; its strategy - get those drugs cheap from China.
I don't see an innovation here, and that bothers me.
The company has huge cash, which is a positive.
EQRx (EQRX) is a late-stage developer of medicines for oncology and immune-inflammatory diseases in the USA. Its stated business goal is to provide low-cost alternatives to existing life-saving but expensive medicines. In order to do this, the company's current strategy seems to be to acquire and then bring to the US medicines already approved in China.
The company's phase 3 programs include:
Aumolertinib, an epidermal growth factor receptor (EGFR) inhibitor for the treatment of patients with EGFR-mutated non-small cell lung cancer (NSCLC);
Sugemalimab, an anti-programmed death-ligand 1 antibody for the treatment of Stage III and Stage IV NSCLC.
Nofazinlimab or EQ176, an anti-programmed death-1 antibody that is in Phase III trials for the treatment of patients with primary liver cancer
Lerociclib, a small molecule cyclin-dependent kinase 4/6 inhibitor, which is in Phase II clinical trials in patients with metastatic breast cancer.
Aumolertinib is the lead program. It recently posted positive data at ASCO:
In a Chinese phase III trial (AENEAS) reported in the Journal of Clinical Oncology, Lu et al found that aumolertinib, a third-generation EGFR tyrosine kinase inhibitor approved in China, significantly improved progression-free survival vs gefitinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation.
Aumolertinib is a China-approved oral Tyrosine Kinase inhibitor or TKI which works similarly to AstraZeneca's (AZN) Tagrisso or Osimertinib. Tagrisso is the current standard of care in this genetic variant of NSCLC, and it has shown superb results compared to gefitinib, an earlier generation TKI. However, Aumolertinib can be used in certain situations:
…in countries where osimertinib may be unavailable or unaffordable. As a potential cost-disruptor, it may introduce tangible price competition and thereby decrease the overall cost of health care.
While Aumolertinib has not been directly compared to osimertinib, both have been compared to gefitinib. Data is as follows; OS data for aumolertinib is not mature at the time of writing, so only mPFS is provided:
Aumolertinib vs gefitinib - median progression-free survival 19.3 months v 9.9 months.
Osimertinib vs gefitinib - median progression-free survival 18.9 months vs. 10.2 months.
Clearly, aumolertinib compares very well to osimertinib. A phase 3b "US-led" trial is ongoing. An MAA has been applied for, and accepted in Europe.
Sugemalimab is the second program. This is an anti-PDL1 antibody targeting later stage NSCLC. This program has the following dataset (quote from Co Presentation):
Stave IV NSCLC - Data presented at ASCO from pre-specified OS analysis, showing 25.4 months of median OS, an estimated 8.5 month improvement over placebo + chemo
Stage III NSCLC - Final PFS data presented at WCLC from final median PFS analysis, showing 10.5 months of median PFS, an estimated 4.3 month improvement over placebo
ENKTL or Extranodal natural killer (NK)/T cell lymphoma - Data presented at ASCO showing 46.2% ORR and 37.2% CR, in a traditionally difficult to treat and aggressive type of NHL お知らせ • Aug 08
EQRx Announces Late-Breaking Oral Presentation of Final Progression-Free Survival Results from Phase 3 Trial of Sugemalimab in Stage III Non-small Cell Lung Cancer at IASLC 2022 World Conference on Lung Cancer EQRx, Inc. announced a late-breaking oral presentation of updated data from the Phase 3 GEMSTONE-301 trial of sugemalimab in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place August 6 through August 9, 2022. These results are being featured in the WCLC press program. As of the March 2022 data cutoff, the final progression-free survival (PFS) analysis of the Phase 3 GEMSTONE-301 trial showed that sugemalimab continued to demonstrate improvement in PFS compared to placebo as consolidation therapy for patients with locally advanced, unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. Median PFS was 10.5 months for sugemalimab and 6.2 months for placebo (hazard ratio [HR]=0.65, 95% CI 0.50–0.84, P=0.0012). PFS benefit was observed in the sugemalimab arm over the placebo arm regardless of whether patients received prior concurrent chemoradiotherapy (15.7 vs. 8.3 months; HR=0.71, 95% CI: 0.50, 1.00) or sequential chemoradiotherapy (8.1 vs. 4.1 months; HR=0.57, 95% CI: 0.38, 0.87). Data for overall survival, a secondary endpoint, were encouraging but immature at the time of the analysis. The safety profile for sugemalimab was consistent with previously reported results, and no new safety signals were identified within the follow-up period. GEMSTONE-301 previously met its PFS primary endpoint in May of 2021 and is the first positive Phase 3 trial of a PD-L1 agent in this Stage III NSCLC patient population setting. お知らせ • Jul 16
EQRx, Inc., Annual General Meeting, Sep 30, 2022 EQRx, Inc., Annual General Meeting, Sep 30, 2022. お知らせ • Jun 15
Eqrx Announces Acceptance of Marketing Authorization Application by U.K.'s Medicines and Healthcare Products Regulatory Agency for Aumolertinib EQRx, Inc. announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for review the marketing authorization application (MAA) for aumolertinib, a third-generation EGFR-tyrosine kinase inhibitor (TKI), in development for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial that evaluated aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC.1 published earlier. お知らせ • May 27
EQRx, Inc. Announces New Data for Lead Oncology Programs in Non-Small Cell Lung Cancer EQRx, Inc. announced data from pivotal trials of sugemalimab, a PD-L1 inhibitor, and aumolertinib, a third-generation EGFR-tyrosine kinase inhibitor (TKI), being presented at the 2022 American Society of Clinical Oncology ASCO) Annual Meeting taking place from June 3 through June 7, 2022. The data further demonstrate the potential clinical benefit of these investigational medicines in non-small cell lung cancer (NSCLC) and of sugemalimab in relapsed or refractory (R/R) extranodal natural killer/T-cell lymphoma (ENKTL), a rare and aggressive form of non-Hodgkin lymphoma (NHL) that does not have approved treatment options in the U.S. These data will help support global regulatory submissions for sugemalimab and aumolertinib. GEMSTONE-302 Study in Stage IV NSCLC The majority of the 1.6 million people diagnosed with NSCLC each year worldwide are found to have Stage IV disease. Prognosis for these patients is poor, with a five-year survival rate of 8%. There is a need for safe, effective and accessible therapeutic options for people with this form of cancer worldwide. The pre-specified interim analysis of overall survival (OS) from the randomized, double-blind Phase 3 GEMSTONE-302 (NCT03789604 [2]) study in patients with previously untreated Stage IV NSCLC demonstrated sugemalimab plus platinum-based chemotherapy reduced the risk of death by 35% compared to platinum-based chemotherapy plus placebo; median OS was 25.4 months for the sugemalimab plus chemotherapy arm versus 16.9 months for the placebo plus chemotherapy arm (hazard ratio [HR]=0.65; 95% CI, 0.50-0.84; P=0.0008). Two-year OS rates were 51.7% for the sugemalimab plus chemotherapy arm and 35.6% for the placebo plus chemotherapy arm. OS benefit was observed in the sugemalimab plus chemotherapy group compared with the placebo plus chemotherapy group across all subgroups, including those with squamous (median OS 23.3 vs. 12.2 months; HR=0.56) and non-squamous NSCLC (median OS 26.9 vs. 19.8 months; HR=0.72) as well as in patients with different levels of PD-L1 expression (PD-L1 =1%, median OS 27.0 vs. 19.0 months, HR=0.64; PD-L1 Journal of Clinical Oncology, which showed treatment with aumolertinib resulted in a clinically significant improvement in PFS compared to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC with the most common types of EGFR mutations. Board Change • Apr 27
High number of new and inexperienced directors There are 12 new directors who have joined the board in the last 3 years. The company's board is composed of: 12 new directors. No experienced directors. No highly experienced directors. Co-Founder, Advisor, Member of Mission Advisory Board & Independent Director Sandra Horning is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. お知らせ • Jan 19
EQRx, Inc. Announces Two Lancet Oncology Publications of Positive Phase 3 Results of Sugemalimab in Stage III and Stage IV Non-Small Cell Lung Cancer EQRx, Inc. announced that data from its partner CStone Pharmaceuticals’ two pivotal Phase 3 studies of the anti-PD-L1 monoclonal antibody sugemalimab for the treatment of non-small cell lung cancer (NSCLC), GEMSTONE-301 and GEMSTONE-302, were published in The Lancet Oncology. The publications were accompanied by a comment article. In GEMSTONE-301, sugemalimab resulted in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo when administered as consolidation therapy in patients with locally advanced, unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. This represents the first positive Phase 3 data for an anti-PD-L1 agent in this broader population of patients with Stage III NSCLC. In GEMSTONE-302, the addition of sugemalimab to standard-of-care chemotherapy as first-line systemic treatment provided a statistically significant, clinically meaningful improvement in PFS in patients with Stage IV NSCLC, regardless of PD-L1 expression levels or pathologic subtype of NSCLC. Results from GEMSTONE-301 reported in The Lancet Oncology are as follows: Sugemalimab as consolidation therapy demonstrated a statistically significant and clinically meaningful improvement in PFS vs. placebo, as assessed by blinded independent central review (BICR) at a prespecified interim analysis. Median PFS was 9.0 months vs. 5.8 months (Hazard Ratio [HR]=0.64, p=0.0026). Clinical benefit was observed in patients who received either concurrent or sequential chemoradiotherapy prior to treatment with sugemalimab compared to placebo. For patients who received prior concurrent chemoradiotherapy (cCRT), median PFS was 10.5 months vs. 6.4 months (HR=0.66). For patients who received prior sequential chemoradiotherapy (sCRT), median PFS was 8.1 months vs. 4.1 months (HR=0.59). Overall survival (OS) data were immature at the time of the analysis, but an encouraging trend for a survival benefit with sugemalimab vs. placebo was observed, with follow-up of patients ongoing. Sugemalimab was generally well-tolerated, with no new safety signals observed. In the sugemalimab group, 9% of patients (n=22/255) experienced grade 3 or 4 treatment-emergent adverse events (TEAEs) related to study treatment. In the placebo group, 6% (7/126) experienced grade 3 or 4 TEAEs related to study treatment. Results of the final PFS analysis from GEMSTONE-302, also reported in The Lancet Oncology, are as follows: Sugemalimab plus platinum-based chemotherapy significantly prolonged PFS (median 9.0 vs 4.9 months; HR=0.48; p<0.0001) compared with placebo plus platinum-based chemotherapy. OS data were immature at the time of the final PFS analysis, but preliminary median OS was 22.8 months in the sugemalimab plus chemotherapy arm compared to 17.7 months in the placebo plus chemotherapy arm (HR=0.67). Clinical benefit was observed across all subgroups, regardless of PD-L1 expression level or pathologic subtype of NSCLC. Sugemalimab was generally well-tolerated, with no new safety signals observed. 53.8% of patients (172/320) in the sugemalimab group and 56.0% (89/159) in the placebo group experienced treatment-related grade 3 or 4 TEAEs, with the most common events for both groups being neutrophil count decrease, white blood cell count decrease, anemia, platelet count decrease and neutropenia. EQRx’s partner, CStone Pharmaceuticals, previously presented results on the use of sugemalimab in the treatment of patients with Stage III and Stage IV NSCLC at ESMO 2021 and the IASLC 2021 World Conference on Lung Cancer, respectively. Sugemalimab is being studied in patients with different stages of NSCLC, in patients with gastric and esophageal cancers and in patients with lymphoma. Board Change • Jan 01
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 3 experienced directors. No highly experienced directors. Founder & Executive Chairman Alexis Borisy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Dec 22
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 12 non-independent directors. Co-Founder, CEO, President, COO & Director Melanie Nallicheri was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. 