On September 10, 2021, PerkinElmer, Inc., a Massachusetts corporation, reported$500,000,000 aggregate principal amount of 0.550% Senior Notes due 2023 (the "2023 Notes"), $800,000,000 aggregate principal amount of 0.850% Senior Notes due 2024 (the "2024 Notes"), $500,000,000 aggregate principal amount of 1.900% Senior Notes due 2028 (the "2028 Notes") and $500,000,000 aggregate principal amount of 2.250% Senior Notes due 2031 (the "2031 Notes" and, together with the 2023 Notes, the 2024 Notes and the 2028 Notes, the "Notes") in a public offering pursuant to a registration statement on Form S-3 (File No. 333-230425) and a base prospectus and a prospectus supplement related to the offering of the Notes (the "Offering"), each as previously filed with the Securities and Exchange Commission (the "SEC") (Press release, PerkinElmer, SEP 10, 2021, View Source [SID1234587522]). The Notes were issued under an indenture, dated as of October 25, 2011 (the "Base Indenture") by and between the Company and U.S. Bank National Association (the "Trustee"), as supplemented by a Seventh Supplemental Indenture, dated as of September 10, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture") by and between the Company and the Trustee. The sale of the Notes was made pursuant to the terms of an Underwriting Agreement (the "Underwriting Agreement"), dated as of September 8, 2021, by and among the Company and Goldman Sachs & Co. LLC, BofA
Securities, Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named in the Underwriting Agreement.
The 2023 Notes will mature on September 15, 2023 and will bear interest at the rate of 0.550% per annum. The 2024 Notes will mature on September 15, 2024 and will bear interest at the rate of 0.850% per annum. The 2028 Notes will mature on September 15, 2028 and will bear interest at the rate of 1.900% per annum. The 2031 Notes will mature on September 15, 2031 and will bear interest at the rate of 2.250% per annum. Interest on the
Notes will be paid semi-annually in arrears on March 15 and September 15 of each year, commencing on March 15, 2022, to holders of record on the preceding March 1 and September 1, respectively.
The Company may not redeem the 2023 Notes or the 2024 Notes prior to September 15, 2022. Prior to July 15, 2028 (two months prior to the maturity date of the 2028 Notes, the "2028 Par Call Date"), in the case of the 2028 Notes or June 15, 2031 (three months prior to the maturity date of the 2031 Notes, the "2031 Par Call Date"), in the case of the 2031 Notes, the Company may redeem the 2028 Notes or the 2031 Notes, as applicable, in whole at any time or in part from time to time, at its option, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest thereon (not including any portion of such payments of interest accrued but unpaid as of the date of redemption) assuming that such Notes matured on the applicable Par Call Date, discounted at the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus 15 basis points in the case of the 2028 Notes or 15 basis points in the case of the 2031 Notes, plus, in each case, accrued and unpaid interest thereon to, but excluding, the date of redemption.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 10, 2021 Omega Therapeutics Inc., a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, reported financial results for the second quarter ended June 30, 2021 (Filing, 8-K, Omega Therapeutics, SEP 10, 2021, View Source [SID1234587521]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our recent successful IPO reinforces our commitment to bring potentially transformative programmable mRNA therapeutics that target the epigenetic basis of disease to precisely control gene expression to patients across a wide range of diseases. We are thrilled to bring in new investors through our IPO and to have the continued support of our existing stockholders," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "The funding provides the necessary financial resources to advance our lead Omega Epigenomic Controller (OEC) candidate, OTX-2002, for the treatment of Hepatocellular Carcinoma through an Investigational New Drug (IND) filing and initial clinical readouts, as well as to continue pre-clinical and IND-enabling studies for several additional OEC development candidates."

Recent Business Highlights and Corporate Update

Financial and Corporate

In August 2021, Omega completed a successful IPO, including shares sold pursuant to the partial exercise of the underwriters’ option to purchase additional shares, raising $141.1 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, and listed on The Nasdaq Global Select Market. The IPO followed the closing of a Series C crossover financing of $126 million in gross proceeds in March 2021.

In May 2021, Luke Beshar was appointed to the Omega Board of Directors and currently serves as the Chair of the Audit Committee. Mr. Beshar is an industry and corporate finance veteran who currently serves on the Board of Directors of Trillium Therapeutics and Protara Therapeutics, and most recently served as Executive Vice President and Chief Financial Officer at NPS Pharmaceuticals, Inc., through its acquisition by Shire PLC.

In March 2021, Elliott M. Levy, M.D., was appointed to the Omega Board of Directors and currently serves on the Nominating and Corporate Governance Committee. Dr. Levy is an industry veteran with over 20 years of senior leadership roles in research and development at global pharmaceutical companies, including Amgen and Bristol-Myers Squibb.

Development Pipeline and Platform

OTX-2002: IND-enabling studies are ongoing for Omega’s lead OEC candidate OTX-2002, a novel, engineered, and programmable mRNA therapeutic being developed for the downregulation of c-Myc oncogene expression in patients with hepatocellular carcinoma. In preclinical studies, OTX-2002 demonstrated its ability to potently down-regulate c-Myc oncogene expression. The Company continues to be on track to file an IND for OTX-2002 in the first half of 2022.

OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable mRNA therapeutics, one that is designed to enable control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs engineered for highly specific targeting and controlled tunability and durability of gene expression. Omega is advancing multiple pre-clinical development programs in regenerative medicine, multigenic diseases including immunology, oncology and select monogenic diseases.

Milestones and Key Priorities

Complete IND-enabling studies for OTX-2002 and successfully file IND application to FDA during the first half of 2022.

Nominate additional OEC development candidates in the first half of 2022.

File a second IND application targeted for second half of 2022.

Continue to develop the OMEGA Epigenomic Programming platform and investigate additional development programs to expand pipeline.

Publish relevant pre-clinical and early clinical data supporting our programs and platform development.

Second Quarter 2021 Financial Results

As of June 30, 2021, the Company had cash and cash equivalents totaling $122.4 million, which does not include the gross proceeds of $141.1 million from the Company’s IPO.

Research and development (R&D) expenses for the second quarter of 2021 were $11.2 million, compared with $4.9 million for the second quarter of 2020. The $6.3 million increase in R&D expenses was primarily due to an increase in discovery and preclinical development costs, related laboratory materials and supplies, and personnel and related expenses as the Company continues to advance its development pipeline.

General and administrative expenses (G&A) for the second quarter of 2021 were $3.6 million, compared with $1.0 million for the second quarter of 2020. The $2.6 million increase in G&A expense was primarily due to higher personnel and related expenses and an increase in professional fees to support business growth.

Net loss for the second quarter of 2021 was $15.4 million, compared with $6.3 million for the second quarter of 2020. The increase in net loss for the second quarter was primarily due to increased research and development and G&A expenses to support the Company’s growth.

On September 10, 2021 Amgen reported that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional marketing authorisation in the UK (Press release, Amgen, SEP 10, 2021, View Source [SID1234587519]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved Lumykras under Project Orbis – an international collaborative programme between the US Food and Drug Administration and regulatory agencies across the world.

KRAS G12C is one of the most common identified or known drivers in non-small cell lung cancer (NSCLC).

Amgen’s med binds with a mutated KRAS G12C protein in a bid to ‘switch off’ the signals it sends to trigger cell division and cancer cell growth.

The MHRA review of Lumykras considered data from the Phase II CodeBreaK 100 clinical study, which evaluated the drug in 126 patients with KRAS G12c-mutated advanced NSCLC.

Results from this trial demonstrated a confirmed objective response rate (ORR) of 37.1% and a disease control rate (DCR) of 80.6% for Lumykras-treated patients.

Recently published data also showed a median overall survival (OS) of 12.5 months among 124 evaluable patients, with the median duration of response (DoR) – evaluated in 46 patients – shown to be 11.1 months.

"Today’s conditional marketing authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options," said Tony Patrikios, executive medical director, Amgen UK and Ireland.

"This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy," he added.

On September 10, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that it presented preclinical data on its Amphiphile (AMP) platform in combination with TCR-T therapy in solid tumors at the 6th Annual CAR-TCR summit, that was held virtually from August 30 – September 2, 2021 (Press release, Elicio Therapeutics, SEP 10, 2021, https://elicio.com/2021/09/elicio-therapeutics-presents-preclinical-data-on-amp-tcr-t-combination-therapy-in-solid-tumors-at-the-car-tcr-annual-summit-2021/ [SID1234587518]). The data was presented in a session co-chaired by industry leaders Adrian Bot, MD, PhD, Vice President of Translational Medicine at Kite, and member of Elicio’s Scientific Advisory Board, and Christopher Heery, MD, Chief Medical Officer of Arcellx Inc., as part of the "Understanding and Managing Toxicity to Enhance Patient Outcomes" workshop.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The preclinical data showed that AMP-boosting transformed an ineffective TCR-T cell monotherapy regimen into a combination which induced long-term non-progression in a fraction animals. It also showed that the AMP combination therapy not only enhanced the expansion and functionality of transferred TCR-T cells but also induced a T-cell response to additional tumor antigens from the original therapy, called antigen spreading, to more broadly attack the tumor." said Peter DeMuth, Ph.D., Elicio Vice President of Research. "We are encouraged by these results because they demonstrate the AMP platform’s ability to enhance multiple axes of immune activation, both systemically as well as in the tumor microenvironment, which may help overcome known challenges to T cell therapy for solid tumors in the clinic."

Adrian Bot, MD, PhD, co-chair of that session, added, "Elicio’s AMP technology is showing promising results in terms of enhancing T cell therapy, through effectively restimulating in vivo the T cells, via deployment of professional antigen presenting cells and co-delivery of biological response modifiers."

This effort expands on the previous work reported in Science from studies conducted at MIT and exclusively licensed to Elicio combining AMP and CAR-T. As observed in the TCR-T combination setting, AMP-boosting of CAR-T cells can promote CAR-T expansion and solid tumor infiltration, contributing to durable responses and resistance to relapse due to loss of CAR-target loss in recurring tumors. Elicio is currently applying this strategy in collaboration with Moffitt Cancer Center to improve CAR-T cell therapies for patients with hematological cancers. This effort is focused on evaluating the combination of CD19 CAR-T AMPlifier, referred to as ELI-011, together with CD19-targeted CAR-T therapy, in mouse models of B cell lymphoma. Positive results in these preclinical assessments may support the advancement of the program into clinical trials.

Presentation will be available on the Elicio Therapeutics website following the Summit via link.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On September 10, 2021 Deciphera Pharmaceuticals, Inc. reported that the Company will host a virtual investor event to review the rebastinib and vimseltinib clinical data to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on Friday, September 17, 2021, from 10:00 AM to 12:30 PM ET (Press release, Deciphera Pharmaceuticals, SEP 10, 2021, View Source [SID1234587517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Deciphera’s senior executive team will be joined by the following key opinion leaders at the event:

Dr. Robert L. Coleman, M.D., FACOG, FACS, Gynecologic Oncologist and Chief Scientific Officer at US Oncology Research
William D. Tap, M.D., Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center