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Advaxis Reports 3rd Quarter Ended July 31, 2021 Financial Results and Provides a Business Update

On September 10, 2021 Advaxis, Inc., a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported its financial results for the third quarter ended July 31, 2021 and provides a business update (Press release, Advaxis, SEP 10, 2021, View Source [SID1234587528]).

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Third Quarter Ended July 31, 2021 Financial Results and Recent Key Accomplishments:

●Entered into a definitive merger agreement with Biosight Ltd. The proposed merger will create a public company, operating as Biosight Therapeutics, to advance a pipeline of clinical-stage oncology programs including Biosight’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the 4th calendar quarter of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol "BSTX".

●The combined company anticipates the following milestones across the combined pipeline over the next 12-18 months:

○Topline results in 65 patients from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in acute myeloid leukemia (AML) patients who are unfit for standard chemotherapy

■Recent data presented at 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed that aspacytarabine alone achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases analyzed to date with negative minimal residual disease (MRD(-) and median duration of response not yet reached at 12 months. Altogether these results are encouraging considering the high-risk factors in this population at baseline;

○Initial results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);

○Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;

○Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and

○Initial results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer

●Initiated Phase 1 clinical trial of ADXS-504 being conducted at Columbia University Irving Medical Center for the treatment of biochemically recurrent prostate cancer, expanding the off-the-shelf ADXS-HOT program to a second indication

●Presented updated clinical data from Part B of the ongoing Phase 1/2 trial of ADXS-503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting; data presented from the Part B arm of this study, demonstrate a disease control rate of 44%, with durable clinical benefit observed including a partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional SD was maintained for approximately 4 months. Translational and biomarker results demonstrate on-mechanism immune activation tied to clinical benefit

●Presented data from Part B of the ongoing Phase 1/2 study of ADXS-503 in combination with KEYTRUDA (pembrolizumab) at the Non-Small Cell Lung Cancer Drug Development Summit

●Announced Nasdaq extension, to November 22, 2021, to regain compliance with the $1.00 minimum bid price rule and complete merger transaction with Biosight, Ltd.

●Cash balance at July 31, 2021 of $45.3 million

Management Commentary

"We are thrilled by the transformative potential of our proposed merger with Biosight and believe the opportunity to build a diversified clinical pipeline with both early and late-stage oncology assets will benefit both patients and our stockholders," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "We expect that the coming months will provide data readouts from our expanded off-the-shelf neoantigen program in both NSCLC and prostate cancer which will build upon our strong foundation of data show consistent clinical benefit, the potential to enhance and/or restore responsiveness to checkpoint inhibitors and on-mechanism innate and adaptive immune system stimulation. These results, in combination with key data readouts from Biosight’s ongoing studies evaluating aspacytarabine in AML and MDS, will elucidate the promise of the combined clinical pipeline across both solid tumors and hematological malignancies and disorders. We look forward to continued progress in the clinic and expect to provide updated guidance regarding the proposed merger before year end."

Third Quarter Ended July 31, 2021 Financial Results

Research and development expenses for the third quarter of fiscal year 2021 were $1.70 million, compared with $3.46 million for the third quarter of fiscal year 2020. The decrease of $1.76 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.

General and administrative expenses for the three months ended July 31, 2021 were at $2.68 million, compared to $2.38 million in the same three-month period in fiscal 2020. The increase of $0.3 million primarily relates to increases in legal and consulting fees, and were partially offset by decreases in rent and utilities, personnel costs, and charges related to the abandonment of non-strategic intellectual property.

As of July 31, 2021, the Company had approximately $45.3 million in cash and cash equivalents.

UroGen Pharma to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 10, 2021 UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference (Press release, UroGen Pharma, SEP 10, 2021, View Source [SID1234587526]). The presentation will be available on-demand via the conference portal and through the Investors section of UroGen’s website, www.urogen.com, beginning at 7:00 a.m. Eastern Time on Monday, September 13, 2021. A replay of the webcast will be available on the website for approximately 30 days.

Portage Biotech Announces Participation in September 2021 Investor Conferences

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]).

Report of unscheduled material events or corporate event

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.

Omega Therapeutics Reports Second Quarter 2021 Financial Results and Outlines Key Corporate Objectives

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]).

"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.