On May 2, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Perimeter Medical Imaging AI, MAY 2, 2022, View Source [SID1234613331]).

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Key Highlights

Perimeter officially progresses to commercial stage with its first S-Series OCT installation.
Clinical development of B-Series OCT with ImgAssist AI advances into late-stage validation activities with the initiation of a multi-center, randomized, two-arm pivotal clinical trial.
The Company issues full-year 2022 commercial installation guidance of 15-20 units.
Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We continue to build upon the significant momentum generated in 2021, which represented a transformative year for Perimeter that was marked by the Company’s first commercial placement of its flagship Perimeter S-Series OCT imaging platform and the initiation of a pivotal trial on our FDA breakthrough-designated device for our investigational Perimeter B-Series OCT combined with ImgAssist artificial intelligence."

Mr. Sobotta continued, "We are grateful for the support from long-term shareholders, as well as Social Capital, who led a recent financing which resulted in gross proceeds of approximately $48.7 million to further strengthen our balance sheet at this critical stage. Moving forward, I believe we are well-positioned to execute on our commercial and clinical development goals. Perimeter is uniquely positioned to draw upon its industry-leading expertise in advanced medical imaging combined with the benefits of machine learning and artificial intelligence tools to support our vision of delivering truly ‘best-in-class’ medical technology solutions to our customers with the goal of improving patient outcomes and reducing healthcare costs."

Corporate and Commercial Milestones

Perimeter received 510(k) clearance for its S-Series OCT imaging platform from the U.S. Food and Drug Administration (FDA), enabling its commercial launch in the U.S. Subsequently, under the leadership of Steve Sapot, Chief Commercial Officer, Perimeter continues to build upon its sales and marketing infrastructure – including key hires of market development managers to cover regions across the U.S.
Perimeter partnered with Minnetronix Medical, a leading medical technology and operations partner to global medical device companies, to secure commercial-scale manufacturing of Perimeter S-Series OCT imaging systems.
Subsequent to year-end, in January 2022, Perimeter closed a private placement resulting in gross proceeds of C$48.7 million to the Company, which included a C$43.4 million strategic investment in the Company by Social Capital.
Clinical and Product Development Milestones

Perimeter received U.S. FDA Breakthrough Device Designation for Perimeter B-Series OCT combined with proprietary ImgAssist artificial intelligence (AI) software – providing a potential expedited pathway for development and adoption of this innovative technology.
Perimeter initiated a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter B-Series OCT with ImgAssist AI for use during breast conservation surgery.
Summary of 2021 Financial Results

All of the amounts are expressed in Canadian dollars unless otherwise indicated and are presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS") applicable to the preparation of interim financial statements, including International Accounting Standard ("IAS") 34, Interim Financial Reporting.

Operating expenses for the year ended 2021 were $16,153,514 compared to $10,159,444 during the previous year.

For the year ended December 31, 2021, the net loss was $16,644,231 compared to $7,885,966 in the prior year.

For the year ended December 31, 2021, cash used in operating activities was $13,912,389.

As at December 31, 2021, cash and cash equivalents were $4,720,003. Subsequent to December 31, 2021, the Company raised additional capital through a private placement resulting in gross proceeds of approximately $48.7 million.

For detailed financial results, please see Perimeter’s filings at www.sedar.com and on the company’s website at View Source

Company Outlook

Perimeter’s sales and marketing efforts will continue to focus on placing its commercially available, flagship Perimeter S-Series OCT at leading hospitals where key opinion leaders can act as champions of this innovative technology, with the goal of reaching an S-Series install base of 15 to 20 units by the end of 2022. In parallel, Perimeter’s clinical team will focus on the continued enrollment of patients and onboarding of healthcare institutions in the ongoing pivotal trial evaluating its next-gen investigational Perimeter B-Series OCT with ImgAssist AI when used in breast lumpectomy procedures, with the goal of gathering data from over 300 patients across 8 sites and completing enrollment in 2022.

Conference Call

Perimeter will host a conference call and audio webcast tomorrow (Tuesday, May 3, 2022) at 5:00 pm Eastern Time to discuss the year-end results and to provide a corporate update. The webcast will be broadcast live on the Investors section of the Perimeter website. To participate in the call, please dial 1-877-704-4453 of 1-201-389-0920 for international callers and provide conference ID number 13729526. To participate in the call, please dial (877) 407-0789 or (201) 689-8562 for international callers and provide conference ID number 13727220.

The webcast will also be archived on the Investors section of the Perimeter website for at least 90 days, and a telephonic playback of the conference call will be available for 14 days following the event by dialing (844) 512-2921 or (412) 317-6671 for international callers and referencing conference ID 13729526.

About the Clinical Development of Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the development of its proprietary, next gen "ImgAssist" artificial intelligence (AI) technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). A multi-center, randomized, two-arm clinical trial is underway to measure the effectiveness of the breakthrough-device-designated Perimeter B-Series OCT + ImgAssist AI in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Approximately 300 patients undergoing breast conservation surgery across eight U.S. clinical sites will participate in the pivotal study led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine, with study enrollment anticipated by the end of 2022.

On May 2, 2022 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported it will present new data from ongoing clinical research evaluating its comprehensive genomic tests at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place June 3-7, 2022 in Chicago, Illinois (Press release, Agendia, MAY 2, 2022, View Source [SID1234613330]).

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Data will highlight Agendia’s clinical focus on whole transcriptome analysis as well as breast cancer care for underserved populations, in addition to several sub-studies derived from the company’s FLEX Registry, the real-world, multicenter, prospective, observational breast cancer study. Two abstracts selected by ASCO (Free ASCO Whitepaper) for oral discussion will feature an investigation of the ImPrint genomic test, currently for research use only, from the I-SPY trial series and an analysis from FLEX of hormone receptor-positive breast cancer in Black women classified by BluePrint.

The company believes the FLEX Registry’s approach to cancer research is accelerating impactful data generation, aimed at redefining cancer care. Its patient-centric design and national network of participating sites is backed by Agendia’s infrastructure, allowing its investigator-initiated sub-studies to produce important results that have the potential to drive science forward, like those being shared at ASCO (Free ASCO Whitepaper) 2022.

Following are details of the nine Agendia abstracts that have been accepted for poster discussion or poster sessions at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting:

Poster discussion sessions

The ImPrint immune signature to identify patients with high-risk early breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2
Authors: Kuilman, MM., et al.
Presenter: Lorenza Mittempergher, PhD | Research and Development, Agendia NV
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1:15 PM-2:45 PM CDT
Abstract #: 514
Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint
Authors: Reid, S., et al.
Presenter: Sonya A. Reid, MD, MPH | Vanderbilt University Medical Center
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1:15 PM-2:45 PM CDT
Abstract #: 517
Poster sessions

Whole transcriptome analysis of tumors with discordant oncotype and MammaPrint results in the FLEX trial
Authors: Socoteanu, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 556
Clinical implications for patients with discordant oncotype and MammaPrint results
Authors: Socoteanu, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 560
Investigation of a genomic signature for transcription factor MAF gene amplification and lack of bisphosphonate benefit in early breast cancer
Authors: Nasrazadani, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 559
Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy
Authors: Chung, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 585
Distribution of breast cancer molecular subtypes within receptor classifications: Lessons from the I-SPY2 trial and FLEX Registry
Authors: Cha, J., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 592
FLEX, the 30,000 breast cancer transcriptome project: A platform for early breast cancer research using full-genome arrays paired with clinical data
Authors: Ma, C., et al.
Session: TBC
Session Date & Time: Monday, June 6, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: TPS612
Defining transcriptomic profiles of early-stage mucinous breast cancers: A FLEX sub study
Authors: Sivapiragasam, A., et al.
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date & Time: Sunday, June 5, 2022 | 8:00 AM-11:00 AM CDT
Abstract #: 3134
Agendia will be sharing important updates on its Twitter, Facebook and LinkedIn pages throughout the conference. The event program can be found at the ASCO (Free ASCO Whitepaper) 2022 website.

On May 2, 2022 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported that it will present new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress 2022 taking place in Berlin, Germany on May 3-5, 2022 (Press release, Agendia, MAY 2, 2022, View Source [SID1234613327]).

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The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint[1] is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing.

"The accessibility of breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to the standardized microarray tests, new doors are opened for global physicians who may need to rely on in-country platforms in order to secure the MammaPrint and BluePrint results their patients may require," said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. "MammaPrint is a valuable tool to support treatment planning for breast cancer patients and with the decentralized NGS platform, this can be offered in even more countries. These findings further confirm that MammaPrint and BluePrint can provide the same accurate results through NGS."

Agendia is expanding novel ways to ensure accessibility of care worldwide by advancing solutions with a decentralized option for testing kits to run on an NGS platform, and innovative modalities such as digital AI pathology. This data presented at ESMO (Free ESMO Whitepaper) Breast follows an announcement from Agendia earlier this year that it is progressing its Digital MammaPrint artificial intelligence (AI)-powered platform in Brazil to potentially fundamentally change the way breast cancer is treated by providing essential information more quickly and elevating the capabilities of global physicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P], builds on earlier research from the landmark MINDACT trial and combines this with the results of the interim analysis of the pilot study performed in Belgium (unpublished data). The budget impact model shows that use of MammaPrint yields savings for breast cancer care in Belgium for the Belgian Health Care Package when compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to criteria of the pilot study leads to high savings. If gene expression profiling was performed for all clinical high risk patients, savings would even be higher.

By combining the cost of genomic testing with the savings made due to a net reduction in chemotherapy usage, the annual savings add up to more than €5,800,000, an average savings of €3,900 per patient, compared with standard clinical care of a patient with breast cancer in Belgium. MINDACT has produced previous multi-country health savings analyses, published in the European Journal of Cancer, showing that genomic testing is beneficial as it provides valuable insights that potentially allow patients to avoid the complexity of chemotherapy, passing down significant financial savings to them while also triggering significant cost savings for large health systems around the world.

"Drawing from the impact data used from the pilot study performed in Belgium, we are able to determine new insights that the use of MammaPrint could grant substantial cost savings to women who may not require chemotherapy and could ultimately alleviate some of the burden on Belgium’s health care system as a whole," said Pino Cusumano, MD, Breast Surgeon, Centre Hospitalier Chrétien, Liège in Belgium. "Data has previously demonstrated that by de-escalating women with Low Risk cases from chemotherapy treatment, outcomes are still as good and women are able to follow a more personalized treatment plan. We believe these data demonstrate that the previous analysis holds for the state of breast cancer care in Belgium in 2022, and that the overall patient benefit extends beyond physical care into financial wellness too."

Taken together, the two posters presented at ESMO (Free ESMO Whitepaper) Breast 2022 suggest that regardless of where the patient is located, she is able to receive the same high-quality results with the added benefit of cost-effective treatment planning.

"The studies presented at EMSO 2022 underpin our central efforts at Agendia to ensure our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to bring the clarity women with breast cancer seek to guide their treatment planning," said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. "Through our steadfast commitment to enable global adoption of MammaPrint and BluePrint, we look forward to continuing studies such as these to grow evidence supporting our mission to serve women with breast cancer throughout their treatment journey."

1MammaPrint and BluePrint next-generation sequencing kits are not yet cleared for sale in the United States by the US Food and Drug Administration; BluePrint has been CE-marked for use in Europe. BluePrint is also commercialized as a Laboratory Developed Test (LDT) and audited under CAP/CLIA in the United States.

On May 2, 2022 HAYA Therapeutics, SA, a company developing precision medicines that target tissue and cell-specific long non-coding RNAs (lncRNAs), reported that Innosuisse, the Swiss Innovation Agency, is supporting two research collaboration projects between HAYA and the University of Bern, University Hospital of Bern and Lausanne University Hospital (Press release, Haya Therapeutics, MAY 2, 2022, View Source [SID1234613326]). Innosuisse is funding 50 percent of the total project costs of approximately CHF 3.1 million (US$3.3 million).

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The first project will advance HAYA’s lead program, an antisense oligonucleotide targeting the lncRNA Wisper, a cardiac tissue-enriched driver of fibrosis in the heart. In collaboration with the Department for BioMedical Research at University of Bern and the Department of Cardiology at University Hospital of Bern (Inselspital), the two-year project will be focused on dosing studies, pharmacodynamics, and pharmacokinetics for this first-in-class therapeutic target for the potential treatment of non-obstructive hypertrophic cardiomyopathy. The study also includes state-of-the-art cardiac MRI read-outs to provide evidence for efficacy and translatability of the therapeutic approach and advancing it towards the clinic and in-need patients.

"The whole team at HAYA is extremely excited to see our lead Wisper-targeting antisense compound being evaluated in a translationally relevant preclinical model of heart failure," said Daniel Blessing, Ph.D., Co-founder and CTO of HAYA Therapeutics. "Support from Innosuisse has been instrumental to enable this study and collaboration with the University and Inselspital Bern."

"As a pioneer in the field of lncRNA, HAYA has made significant progress in developing a novel treatment targeting lncRNA for hard-to-treat cardiac diseases," said Dr. Robert Rieben, Professor at the University of Bern. "With experience in preclinical cardiovascular research, we are excited to work with HAYA and support their efforts of bringing this therapy to patients who desperately need them."

HAYA’s second project will aim to develop a next-generation oncology therapy targeting cancer-associated fibroblasts for the treatment of squamous cell carcinoma. Through a partnership with Lausanne University Hospital (Centre hospitalier universitaire vaudois, CHUV), the collaborators will use HAYA’s proprietary drug discovery engine, DiscoverHAYATM, to identify oncology-associated fibroblast-specific lncRNAs for the development of a precision RNA-targeted therapy.

"Since launch, HAYA has been diligently working on bringing our lead lncRNA-targeting antisense candidate for the treatment of heart failure closer to clinical testing. At the same time, we have been conducting studies using our innovative discovery engine to identify novel lncRNA targets outside of cardiomyopathy," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "With this project funding from Innosuisse, we can continue our efforts in heart disease and use our technology beyond cardiology into cancer. This will open up tremendous opportunities in the discovery of oncology-based lncRNA targets."

On May 2, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported six poster presentations at PEGS (The Essential Protein Engineering & Cell Therapy Summit) Boston occurring May 2-6 virtually and in-person at the Hynes Convention Center in Boston, MA (Press release, Twist Bioscience, MAY 2, 2022, View Source [SID1234613325]). In addition, Aaron Sato, Ph.D., chief scientific officer of Twist Bioscience, will present ‘Writing the Future of Biologics’ on May 2 at 2:50 PM ET and Tracey Mullen, SVP, operations, will present ‘Rapid, Function-Forward mAb Discovery against a Cell Surface Target via Concurrent Use of Humanized and Hyperimmune Mice’ on May 4 at 12:30 PM ET. Twist will also host a networking event on May 4 from 7:00-10:00 PM ET. Visit https://bit.ly/TwistMixer to register.

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"These posters show the depth and breadth of the antibody discovery and library construction capabilities of Twist Biopharma against high-impact targets," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Our next generation libraries enable antibody discovery for therapies such as CAR-T engineered cell therapies, which have the potential to change the treatment landscape for patients. In addition, the data presented on the discovery of an antibody targeting ADORA2A, a next generation checkpoint, demonstrate Twist Biopharma’s ability to generate antibodies independently."

Poster Number: P003

Advanced Antibody Discovery Workflow to Capture Maximum Repertoire Diversity

The complexity of antibody therapeutic targets continues to evolve, which in turn necessitates the evolution of integrated discovery methodologies. Incorporating state-of-the-art, high-resolution techniques enables reliable candidate triage more efficiently than traditional techniques. Major advancements in critical tools have improved antibody discovery by providing robust and thorough analysis of target specificity, function, and developability earlier in the drug development process. Effective integration of these technologies bolsters the antibody discovery process and facilitates lead candidate selection within as few as two months.

Poster Number: P004

In Vivo VHH Discovery Workflow Based on Immunized Alpaca and Rapid Beacon-Based Single B Cell Screening

VHH antibodies have demonstrated tremendous promise as versatile building blocks for antibody-based therapeutics, multispecifics and cell-based biologics due to higher affinity and better access to hidden epitopes on cell surface targets as compared to conventional IgG antibodies. Effective integration of advanced tools for analysis of target specificity, function and developability can bolster the VHH discovery process and facilitate lead candidate selection for novel therapeutic modalities against traditionally challenging targets.

Poster Number: P143

Next Generation Synthetic Libraries for Enzyme Engineering, Cell Therapy and Gene Editing Technologies

This poster details Twist’s next generation libraries including CRISPR gRNA libraries, which are an efficient tool for high throughput gene editing and knockout of molecular targets; synonymous codon (SynCodon) libraries, which are optimized to improve protein yields, binding affinity, stability, and expression of proteins; and T cell receptor (TCR) and chimeric antigen receptor (CAR) T cell libraries, which can be used in combination to screen a large scale of module sets.

Poster Number: P144

Discovery of Pre-clinical ADORA2A Antibody with Twist High Throughput Antibody Discovery Platform

These data detail how Twist used its high-throughput DNA synthesis platform and a large-scale phage library built based on a mouse immunization platform from Abveris, a division of Twist Bioscience, to discover a high-affinity antagonistic ADORA2A antibody, which in preclinical studies restored T cell activity and showed anti-tumor activity.

Poster Number: P145

Engineering Synthetic Multivalent VHH Antibodies at Scale

These data describe Twist’s scalable process for engineering high affinity mono and bispecific multivalent VHH-Fc antibodies against the SARS-CoV-2 spike protein.

Poster Number: P146

Leveraging synthetic Library of Libraries to enable effective antibody discovery against high-impact targets

This poster demonstrates how Twist discovered high-affinity antibodies for six cytokine or immunomodulatory targets by constructing synthetic antibody libraries, using phage display to pan libraries against biotinylated protein targets, and screening for lead candidates through ELISA binding assays and NGS enrichment tracking.

About Twist Biopharma

By leveraging our unique ability to manufacture DNA at scale, we can construct proprietary antibody libraries precisely designed to match sequences that occur in the human body. The Library of Libraries gives our partners an integral and unbiased resource for antibody discovery and optimization. This precise and rational approach to library fabrication combined with sophisticated bioinformatics and software expertise expedites antibody discovery by decreasing risk, increasing speed, and lowering the failure rate for antibody development.