On September 10, 2021 Immunocore Holdings plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported that management will present at the following investor conferences in September (Press release, Immunocore, SEP 10, 2021, View Source [SID1234590901]).

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H.C. Wainwright 23rd Annual Global Investment Conference
Fireside Chat available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Fireside Chat: Wednesday, September 22, 2021 at 2:05 p.m. ET
The investor conferences will each be held in a virtual format and a live webcast of each presentation can be accessed in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. For conferences that offer replays, presentations will be made available for a limited time.

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]).

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"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, 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.

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On September 09, 2021 Vor Biopharma, a clinical-stage cell and genome engineering company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VOR33, the Company’s lead engineered hematopoietic stem cell (eHSC) therapeutic candidate for the treatment of acute myeloid leukemia (AML) (Press release, PureTech Health, SEP 10, 2021, View Source [SID1234587506]).

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VOR33 consists of CRISPR genome-edited hematopoietic stem and progenitor cells that have been engineered to lack CD33. Once infused, VOR33 is designed to protect patients’ healthy cells from anti-CD33 therapies, such as VCAR33 or Mylotarg (gemtuzumab ozogamicin). VOR33 is intended to replace standard of care transplants for AML patients who are at high risk of relapse and has the potential to seamlessly integrate into current transplant settings.

"Receiving Fast Track designation is an important milestone for Vor, which signals the FDA’s recognition of the serious and life-threatening medical condition of patients facing acute myeloid leukemia and the potential of VOR33 to address this unmet medical need," said Robert Pietrusko, PharmD, Vor’s Chief Regulatory and Quality Officer. "We will continue to work closely with the FDA to expedite the development of VOR33, which is now actively enrolling in its Phase 1/2a clinical trial for AML patients who currently have limited treatment options. We continue to remain on-track to report VOR33’s initial clinical data in the first half of 2022."

VOR33 is the lead product candidate of Vor’s novel scientific platform, which has the mission to create next-generation, treatment-resistant transplants that unlock the potential of targeted cancer therapies by leveraging advances in cell therapy and gene editing. Vor is currently exploring the use of its genome engineered hematopoietic stem cell platform in combination with multiple therapeutic modalities.

Fast Track designation is intended to facilitate development and expedite review of products designed to treat serious and life-threatening conditions with unmet medical needs. The designation is granted upon the FDA’s review of data that demonstrate this potential, along with a product development program that is adequately designed to address the unmet medical need. Therapeutic candidates receiving Fast Track designation may be eligible for priority review and accelerated approval if certain conditions are met.

On September 10, 2021 Portage Biotech Inc., a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported that as part of its commitment to investor outreach, management will be participating in the following investor conferences in September 2021 (Press release, Portage Biotech, SEP 10, 2021, View Source [SID1234587524]).

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