On March 31, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that unaudited net revenue for 2021 of $61.2 million and cash and cash equivalents as of December 31, 2021 of approximately $28 million (Press release, Biocept, MAR 31, 2022, View Source [SID1234611318]).

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"Revenue reached a record high in 2021, up 123% over the prior year driven primarily by RT-PCR COVID-19 testing. As anticipated, we are currently experiencing a decline in COVID-19 testing demand as the unpredictable pandemic begins shifting to an endemic stage. Also, in the fourth quarter of 2021 we once again achieved sequential-quarter volume growth for CNSide, our proprietary cerebrospinal fluid assay for the detection and monitoring of cancer involving the central nervous system," said Samuel D. Riccitelli, Biocept’s Chairman, and interim President and CEO. "We anticipate reporting positive cash flow from operations for 2021 and ended the year with a cash balance of approximately $28 million."

As a result of the restatement of financial results for the quarter ended September 30, 2021, the implementation of additional accounting review and control procedures, and resource constraints, the accounting review of Biocept’s financial statements as of and for the year ended December 31, 2021 is ongoing. Biocept is filing a notification of late filing on Form 12b-25 with the Securities and Exchange Commission, which provides an automatic 15-day extension of the filing deadline for its Annual Report on Form 10-K for the year ended December 31, 2021, to April 15, 2022. The net revenue and cash and cash equivalent data presented in this news release should be considered preliminary and could be subject to change as the company’s independent registered public accounting firm has not completed its audit. Biocept anticipates filing its Form 10-K for the year ended December 31, 2021 by April 15, 2022 or as soon as practicable.

On March 31, 2022 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, reported that company management will participate in the following upcoming investor conferences (Press release, Arrakis Therapeutics, MAR 31, 2022, View Source [SID1234611317]):

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Michael Gilman, Ph.D., Chief Executive Officer of Arrakis, will participate in a panel discussion on Thursday, April 7, 2022 at 11:00 a.m. ET in New York. Company management will also participate in one-on-one meetings.

21st Annual Needham Virtual Healthcare Conference
Company management will participate in one-on-one meetings on Tuesday, April 12, 2022.

On March 31, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that the company will be presenting two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8-13 (Press release, Immunomic Therapeutics, MAR 31, 2022, View Source [SID1234611316]). The posters to be presented at AACR (Free AACR Whitepaper) are developed from the investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma and Her2/Neu-LAMP DNA vaccine, both which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1). This proprietary lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response.

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"Both ITI-3000 and Her2/Neu-LAMP DNA vaccines are innovative and novel targeted approaches," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by the data and look forward to a first-in-human trial for ITI-3000, a vaccine for Merkel cell carcinoma, and further pre-clinical development for Her2/Neu-LAMP vaccine."

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses, tumor inhibition, and provides rationale for first-in-human trial

Session Category: Immunology

Session Title: Immune Response to Therapies 1

Session Date and Time: Monday April 11, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37

Poster Number: 10

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Poster Title: Harnessing soluble CD40L to enhance anti-tumor efficacy of Her2-LAMP DNA vaccine using UNITE platform

Session Category: Immunology

Session Title: Vaccines: Oncolytic and Prophylactic

Session Date and Time: Tuesday April 12, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 40

Poster Number: 3

Poster Availability: e-Posters will be on display in the AACR (Free AACR Whitepaper) Gallery

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

On March 31, 2022 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, reported that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval (Press release, Guided Therapeutics, MAR 31, 2022, View Source [SID1234611315]). The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval shortly thereafter.

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In addition, the Company’s Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), made a scheduled milestone payment to the Company of $177,740. A portion of these funds will be used to supply SMI with LuViva devices and parts. According to SMI, both the interim safety and accuracy results of LuViva justify the completion of the clinical study and submission of the data to the NMPA as soon as practicable.

"We are pleased to hear that LuViva has performed well and as expected in the first clinical trials in China," said Gene Cartwright, CEO of Guided Therapeutics. "We look forward to a speedy conclusion and filing of study results with the Chinese regulatory authorities."

On March 31, 2022 Biognosys, a leader in next-generation proteomics solutions for drug discovery and development, reported the details of its presence at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which will be held April 8-13, 2022, both in person in New Orleans, US and virtually (Press release, Biognosys, MAR 31, 2022, View Source [SID1234611314]). The company will be presenting a talk and five scientific posters around two of its major service platforms, TrueDiscovery and TrueTarget. Additionally, Biognosys contributed to a poster that will be presented by its collaborator, NeoGenomics.

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"The proteome contains a wealth of information about health and disease, and mass spectrometry-based proteomics has great potential in uncovering that information," commented Lukas Reiter, Ph.D., Chief Technology Officer at Biognosys. "Our AACR (Free AACR Whitepaper) data shows how Biognosys has been able to establish mass spectrometry-based proteomics technology to provide detailed and unbiased insights about the proteome. We illustrate how we’ve been able to increase efficiency and scalability at every step of the process. Moreover, we’re showcasing data we’ve generated with our collaborators that demonstrate the practical application of our platforms across all stages of research and drug development, from discovery to clinical settings."

Biognosys will also be present with a team of scientific experts at booth #885.

Talk Details

Abstract 2136: Prediction of small molecule-protein binding events for BRD4 and EGFR inhibitors using HR-LiP, a novel structural proteomics approach
Presenter: Yuehan Feng, Ph.D.
Collaborator: Cedilla Therapeutics
Platform, Technology and Application: TrueTarget, High Resolution Limited Proteolysis Mass Spectrometry (HR-LiP), Drug Target Validation
Session: Drug Design and Lead Optimization Strategies Toward Novel or Difficult-to-Drug Cancer Targets
Date and Time: Monday, April 11, 3:20 p.m. – 3:35 p.m. CDT
Poster Presentation Details

Abstract 1374: Discovery of MHC class I and class II neoantigens in lung cancer in needle biopsy tissue samples using an optimized high-throughput workflow
Presenter: Marco Tognetti, Ph.D.
Platform, Technology and Application: TrueDiscovery, Hyper Reaction Monitoring, Immunopeptidome Profiling
Session: Tumor Antigens, Antigen Presentation, and Tumor Immunity
Date and Time: Monday, April 11, 9:00 a.m. – 12:30 p.m. CDT
Abstract 3110: Identification of the phosphorylation network in PDX and corresponding organoid (PDXO) models upon targeted therapy treatment using deep phosphoproteomic analysis
Presenter: Yuehan Feng, Ph.D.
Collaborator: Crown Bioscience
Platform, Technology, and Application: TrueDiscovery, Hyper Reaction Monitoring, Phosphoproteome Profiling
Session: Patient-Derived Xenografts
Date and Time: Tuesday, April 12, 1:30 p.m. – 5:00 p.m. CDT
Abstract 2924: Target identification, selectivity profiling and mechanistic insights of a CDK9 inhibitor using complementary proteomics methods
Presenter: Yuehan Feng, Ph.D.
Collaborator: AstraZeneca plc
Platform, Technology and Application: TrueTarget, Limited Proteolysis Mass Spectrometry (LiP-MS), Drug Target Deconvolution
Session: Structural and Chemical Biology
Date and Time: Tuesday, April 12, 9:00 a.m. – 12:30 p.m. CDT
Abstract 3923: Ubiquitin ligases implicated as predictive biomarkers for poor outcome to immunotherapy in melanoma patients
Presenter: Jakob Vowinckel, Ph.D.
Collaborator: NeoGenomics Laboratories
Platform, Technology and Application: TrueDiscovery, Hyper Reaction Monitoring, Tissue Biomarker Discovery
Session: Proteomics, Signaling Networks, and Biomarker Discovery
Date and Time: Wednesday, April 13, 9:00 a.m. – 12:30 p.m. CDT
Abstract 3920: Precise solid tumor classification through unbiased quantification of proteoforms deep into tissue leakage
Presenter: Marco Tognetti, Ph.D.
Platform, Technology and Application: TrueDiscovery, Hyper Reaction Monitoring, Biofluid Biomarker Discovery
Session: Proteomics, Signaling Networks, and Biomarker Discovery
Date and Time: Wednesday, April 13, 9:00 a.m. – 12:30 p.m. CDT
NeoGenomics Poster Collaboration Details

Abstract 1267: Dual approach using unbiased proteomics and multiplexed immunofluorescence for the detection of markers predictive for immunotherapy in melanoma patients
NeoGenomics Presenter: Anna Juncker-Jensen, Ph.D.
Biognosys co-authors: Nigel Beaton, Ph.D.; Kristina Beeler, Ph.D. Tobias Treiber, Ph.D.; Jakob Vowinckel, Ph.D.
Platform, Technology and Application: TrueDiscovery, Hyper Reaction Monitoring, Tissue Biomarker Discovery
Session: Biomarkers Predictive of Therapeutic Benefit 2
Date and Time: Monday, April 11, 9:00 a.m. – 12:30 p.m. CDT
For the most up to date information and resources about Biognosys’ presence at AACR (Free AACR Whitepaper), visit biognosys.com/accr22.

About TrueDiscovery

The Biognosys TrueDiscovery platform offers integrated proteomics solutions across the entire drug development pipeline.

TrueDiscovery is powered by Hyper Reaction Monitoring (HRM) mass spectrometry, an advanced Data Independent Acquisition (DIA)-based protein quantification technology co-invented and patented by Biognosys.

TrueDiscovery is the only platform that searches the complete proteome to quantify thousands of the most relevant proteins, including an unlimited number of proteoforms. The platform enables the deepest unbiased profiling of tissue and biofluids proteomes with unbeatable specificity on a large scale. The generated data are highly reproducible and easily transferrable to clinical assays. Studies can be performed in a GLP certified and GCP compliant environment. For more information, visit truediscovery.bio.

About TrueTarget

The Biognosys TrueTarget proteomics platform uniquely addresses the most pressing challenges in early drug discovery by identifying on- and off-targets to accelerate and de-risk drug development throughout the pipeline.

TrueTarget is powered by Limited Proteolysis Mass Spectrometry (LiP-MS), a proprietary, patented chemoproteomics technology co-developed by Biognosys.

TrueTarget is the only tool to probe structural changes across the complete proteome with peptide-level resolution, providing unique insights into compound binding and target identification. The platform enables elucidating mechanisms of action and revealing unanticipated toxicities. For more information, visit truetarget.bio