On April 12, 2022 OncoNano Medicine, Inc. reported positive results from the company’s ON-BOARD pH-sensitive nanoparticle platform (Press release, OncoNano Medicine, APR 12, 2022, View Source [SID1234612065]). The data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, demonstrate that the clinically validated ON-BOARD platform has the potential to be a universal tool for tumor specific activation and the efficient delivery of proteins for an improved therapeutic index .

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"Our ON-BOARD micelle platform is designed to efficiently carry a broad range of payloads to the tumor microenvironment. Capable of being tuned to deliver either small molecules or biologics, the ON-BOARD platform has the potential to be a universal tool for targeted delivery of therapeutics to a range of cancers," said Tian Zhao, Ph.D., Vice President of Research & Development for OncoNano Medicine, Inc. "We are pleased with the positive data from our research efforts to encapsulate therapeutic antibodies with our ON-BOARD delivery technology and look forward to the further development of protein payloads with an improved therapeutic index."

A variety of biosimilar monoclonal antibodies including those of atezolizumab, cetuximab, pembrolizumab, trastuzumab and ipilimumab were encapsulated by the ON-BOARD platform.
The findings indicate that ON-BOARD demonstrated:
• Encapsulation of antibodies without additional modification of the original antibody
• Encapsulation efficiency ranging from 50-100%
• Formulations characterized as uniformly distributed particles < 100nm in size with good stability
• Over a 100-fold activation window between the acid-activated and intact formulations based on in vitro assessment by cell-based reporter assays
• pH-dependent activation that was further confirmed by affinity and binding assay
• Tumor specific accumulation that was demonstrated by a biodistribution study

Presentation Overview

TITLE: Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform

PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine

On April 12, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Thomas Heineman, M.D., Ph.D., the Company’s Chief Medical Officer, will be participating in a fireside chat at the Canaccord Genuity Horizons in Oncology Virtual Conference (Press release, Oncolytics Biotech, APR 12, 2022, View Source [SID1234612063]). Additional details on the fireside chat are provided below.

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Date: Thursday, April 14, 2022
Time: 10:00 a.m. ET
Webcast: Please click here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Canaccord representative or email [email protected].

On April 12, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that received a notification from the NYSE American stating that the Company was not in compliance with the $6.0 million stockholders’ equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide (Press release, Navidea Biopharmaceuticals, APR 12, 2022, View Source [SID1234612061]). As required by the NYSE American, the Company submitted a plan to the NYSE American by February 28, 2022 advising of actions it has taken or will take to regain compliance with the continued listing standards by July 28, 2023.

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On April 8, 2022, the Company received notification (the "Acceptance Letter") from the NYSE American that the Company’s plan to regain compliance was accepted. The Acceptance Letter also stated that the Company is also not in compliance with Sections 1003(a)(i) and 1003(a)(ii) of the NYSE American Company Guide, which require an issuer to have stockholders’ equity of (i) $2.0 million or more if it has reported losses from continuing operations and/or net losses in two out of its three most recent fiscal years, and (ii) $4.0 million or more if it has reported losses from continuing operations in three out of its four most recent fiscal years. The Acceptance Letter noted that the Company had stockholders’ equity of $624,743 as of December 31, 2021 and has reported net losses from continuing operations in its five most recent fiscal years ended December 31, 2021.

The NYSE American has granted the Company a plan period through July 28, 2023 to regain compliance with Sections 1003(a)(i), (ii) and (iii). If the Company is not in compliance with all continued listing standards by that date or if the Company does not make progress consistent with the plan during the plan period, the NYSE American may commence delisting procedures.

Navidea’s common stock will continue to be listed on the NYSE American while it attempts to regain compliance with the listing standards noted, subject to Navidea’s compliance with other continued listing requirements. The common stock will continue to trade under the symbol "NAVB," but will have an added designation of ".BC" to indicate that Navidea is not in compliance with the NYSE American’s listing standards. The NYSE American notification does not affect Navidea’s business operations or its SEC reporting requirements and does not conflict with or cause an event of default under any of Navidea’s material agreements.

On April 12, 2022 Nascent Biotech, developer of Pritumumab (PTB), a monoclonal antibody showing promise in the treatment of brain cancer, reported that it has partnered with BioTools, Inc to clearly define PTB’s higher order molecular structure (HOS) (Press release, Nascent Biotech, APR 12, 2022, View Source [SID1234612059]).

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Nascent is exploring the potential of modifying the antibody to enhance its effectiveness and to broaden its therapeutic application. BioTool’s groundbreaking ROA laser-based technology provides detailed and complete structural characterization at all stages of development including formulation and stability. ROA spectrum generates a structural snapshot and unique signature for each product and each modification.

PTB is a natural human IgG1 antibody isolated from a patient with cervical carcinoma. It is a protein molecule comprised of multiple amino acid units linked together into a chain which can then fold into various configurations. Both the folding ("secondary structure") and the more extensive, 3-dimensional results ("tertiary structure") have dramatic impact on the molecule’s pharmaceutical effectiveness.

"BioTools is known worldwide for their knowledge and expertise in the field of Raman, ROA, and biologic FTIR. We are very pleased to have had an opportunity to work with their scientists to deliver this refined capability for our monoclonal antibody (mAb) development platform."-Sean Carrick, CEO, Nascent Biotech Inc.

"Nascent’s mAb PTB is an ideal match for our instrumentation as well as for our vision of expanding Raman/ROA+FTIR to more widespread, routine use in BioPharma research labs. This suite of techniques, coupled with the accompanying BioTools’ databases and software, have powerful application to the characterization of higher order structures for many therapeutics."-BioTools, President & Co-Founder, Dr. Rina Dukor

On April 12, 2022 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported preliminary total product and service revenue of approximately $31 million for the first quarter (Press release, NanoString Technologies, APR 12, 2022, View Source [SID1234612058]). This unaudited estimate, based on management’s preliminary financial analysis, is lower than the company’s previous guidance for product and service revenue of $34 million to $38 million for the first quarter of 2022.

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Preliminary First Quarter Financial Results
•Product and service revenue of $31 million
•GeoMx Digital Spatial Profiler (DSP) revenue of $10 million. GeoMx DSP revenue includes:
◦Instrument revenue of $5 million, 31% year-over-year decline
◦Consumables revenue of $5 million, 78% year-over-year growth, annualized pull-through of approximately $76,000 per installed system
•nCounter revenue, inclusive of all service revenue, of $21 million. nCounter revenue includes:
◦Instrument revenue of $4 million, 11% year-over-year decline
◦Consumables revenue of $13 million, 5% year-over-year decline, annualized pull-through of approximately $48,000 per installed system
◦Service revenue of $4 million, 16% year-over-year growth
•CosMx Spatial Molecular Imager (SMI): Generated orders for more than 15 CosMx SMI systems, bringing total orders to date to more than 35 systems
"Our first quarter revenue fell short of our expectations. After reviewing the preliminary results with the benefit of hindsight, we believe our Q1 revenue was impacted primarily by two factors. First, uneven sales execution resulted in an imbalance between capturing fourth quarter revenue and developing our Q1 2022 funnel of opportunities. Second, we believe this was compounded by the impact of changes made to re-align our expanded commercial team early in the year," said Brad Gray, President and CEO of NanoString. "Customer interest in spatial biology continues to be strong, and we remain confident in our long-term prospects. We’re currently evaluating our financial outlook for the full year and plan to provide an update on our earnings call on May 10th."

Conference Call
The Company plans to host a conference call on Tuesday April 12, at 5:00pm ET to discuss these preliminary results and provide more details. Investors and other interested parties should register for the conference call in advance by visiting View Source Following registration, an email confirmation will be sent that includes dial-in details and unique conference call codes for entry. Registration is open throughout the call but to ensure connection for the full call, registration in advance is recommended. The link to the live webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com.
A replay of the call will be available beginning April 12, 2022 around 7:30pm ET through midnight on April 19, 2022. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 508842. The webcast will also be available on the Company’s website for one year following the completion of the call.
The Company plans to release full operating results for first quarter of 2022 after the close of trading on Tuesday, May 10, 2022. Company management will host a conference call beginning at 4:30pm ET to discuss those results and provide updated financial guidance.