On April 20, 2022, Monopar Therapeutics Inc. ("Monopar" or the "Company") reported that entered into a Capital on DemandTM Sales Agreement (the "Agreement") with JonesTrading Institutional Services LLC ("JonesTrading" or the "Agent"), pursuant to which Monopar may offer and sell, from time to time, through or to JonesTrading, as sales agent or principal, shares of Common Stock, par value $0.001 per share (the "Shares") (Filing, 8-K, Monopar Therapeutics, APR 20, 2022, View Source [SID1234612585]). On April 20, 2022, the Company filed a prospectus supplement relating to the offer and sale of Shares from time to time pursuant to the Agreement up to an aggregate amount of $4,870,000.

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The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-235791) (the "Registration Statement") filed by the Company with the Securities and Exchange Commission (the "SEC") on January 3, 2020 and declared effective by the SEC on January 13, 2020, as supplemented by a prospectus supplement dated April 20, 2022 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"). This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Company’s Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Monopar is not obligated to sell any Shares under the Agreement. Upon delivery of a placement notice by Monopar and subject to the terms and conditions of the Agreement and such placement notice, JonesTrading may sell the Shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act and will use commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq Capital Market, to sell the Shares from time to time.

The offering of Shares pursuant to the Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by JonesTrading or the Company, as permitted therein.

The Company has agreed to pay JonesTrading commissions for its services in acting as agent in the sale of the Shares in the amount of up to 3% of gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide JonesTrading with customary indemnification and contribution rights, in connection with entering into the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The opinion of the Company’s counsel regarding the validity of the Shares that may be issued pursuant to the Agreement is also filed herewith as Exhibit 5.1.

On April 20, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Jounce management will participate in a fireside chat at the Raymond James LILRB/ILT Symposium: Deep Dive into "Myeloid Checkpoint" Therapeutics in Cancer taking place virtually on Tuesday, April 26, 2022 at 1:00 pm ET (Press release, Jounce Therapeutics, APR 20, 2022, View Source [SID1234612584]).

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On April 20, 2022 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its first quarter 2022 financial results on Tuesday, May 3, 2022, and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, APR 20, 2022, View Source [SID1234612583]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and access codes.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

On April 20, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will participate in the following upcoming investor, partnering, and scientific conferences (Press release, Greenwich LifeSciences, APR 20, 2022, View Source [SID1234612581]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright Global Investment Conference – May 23-26, 2022

The Company will be participating in the H.C. Wainwright Global Investment Conference in Miami, Florida with an in-person presentation and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The conference will feature leading industry keynote speakers and presenting companies, investor one-on-one meetings, and networking opportunities with attendees. For more information, please visit the conference website at: View Source

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – June 3-7, 2022

The Company will present 2 posters and 3 abstracts at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL and will meet with clinical sites and networks participating in the upcoming FLAMINGO-01 phase III clinical trial. Founded in 1964, ASCO (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

Jefferies Healthcare Conference – June 8-10, 2022

The Company will be participating in the Jefferies Healthcare Conference in New York, NY with an in-person presentation and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. This conference gathers leading executives, institutional investors, private equity investors, and venture capitalists to address investment opportunities and to discuss the current trends driving healthcare globally. Jefferies is one of the largest healthcare investment banking teams in the world with over 135 professionals worldwide based in New York, San Francisco, London and Hong Kong covering over 1010 companies.

BIO International Convention – June 13-16, 2022

The Company will be participating in the BIO International Convention in San Diego, CA with an in-person presentation and one-on-one partnering meetings. The convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking including scheduled one-on-one meetings with senior business development executives seeking potential financial and strategic partners. For more information please visit: View Source

The Company also previously participated in the following events:

Susan G. Komen’s More Than Pink Luncheon – March 10, 2022

The Company was an event sponsor and invited members of the upcoming FLAMINGO-01 clinical trial team to participate in this Houston, Texas event. The second annual More Than Pink Luncheon celebrated the vision of Komen’s founders with the hope and increasing promise of a cure. Susan G. Komen is the world’s leading nonprofit breast cancer organization, working to save lives and end breast cancer forever. Komen has an unmatched, comprehensive 360-degree approach to fighting this disease across all fronts and supporting millions of people in the U.S. and in countries worldwide. Visit www.komen.org.

BIO-Europe Spring – March 28-31, 2022

The Company participated in the BIO-Europe Spring partnering event which includes international business development, therapeutic areas, startup innovations, digital health, and scheduled one-on-one meetings with regional and global pharma companies. For more information, please visit the conference website at: https://informaconnect.com/bioeurope-spring/

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On April 20, 2022 Aiforia Technologies Plc reported the CE-IVD marking of the Aiforia Clinical AI Model for Breast Cancer; ER (Press release, Aiforia Technologies, APR 20, 2022, View Source [SID1234612580]). Adding to its repertoire of CE-IVD marked clinical AI models for cancer diagnostics, the new AI model automates the calculation of estrogen receptors (ER) — a group of proteins present in the majority of breast cancers, therefore a vital biomarker in its diagnosis, as well as a commonly used predictive factor for treatment and prognostic factor for survival in breast cancer.

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Pathologists are essential to healthcare, evaluating patient samples to guide diagnosis and treatment. Increasing rates of disease like cancer, the prevalence of which according to the World Health Organization Report on Cancer 2020 is expected to rise by 47.4% between 2020 and 2040, are creating a growing burden on pathologists. This challenge is exacerbated by the fact that pathologists rely on manual slide analysis with microscopes; a cumbersome and variability-prone technique. These semi-quantitative methods of evaluating patient samples are also widely adopted in labs around the world in calculating ER as part of breast cancer diagnostics.

Through automation and digital tools clinical pathology labs can increase the speed and accuracy of their work, thereby enabling patients to receive diagnoses and treatment plans faster while also alleviating the strain on pathologists. Aiforia is meeting the demands for enhanced technology with deep learning AI software and tools for supporting pathologists in diagnostics as well as in automating clinical workflows.

ER_mockup_clinical_1c

The CE-IVD marked Aiforia Clinical AI Model for Breast Cancer; ER has the potential to improve the prognostic and predictive value of ER analysis in breast cancer diagnostics.

The CE-IVD marked Aiforia Clinical AI Model for Breast Cancer; ER has the potential to improve the prognostic and predictive value of ER analysis in breast cancer diagnostics through its unique functionalities: automating the detection of tumor areas as well as the calculation of ER-positive and negative cells from whole slide images (WSIs) and selected areas and even the viewing and selection of areas with high ER-positive density, or hotspots. Ultimately displaying the AI-assisted image analysis results to pathologists in a timely and consistent manner.

"The Aiforia Clinical AI Model for ER showed to produce robust, quantifiable and consistent data. This in turn can lead to significant time savings and clinical workflow improvements for pathology labs as the evaluation time per case required from a pathologist is reduced." explains Dr. Juuso Juhila, Director of Clinical Products at Aiforia Technologies. "The AI model also provides the ability to predict which patients are most likely to respond to endocrine therapy, a highly efficacious targeted breast cancer treatment."

Aiforia Technologies is currently developing its Clinical Suites, a portfolio of novel deep learning AI and cloud-based tools for pathologists to work with whole slide digitized images from different scanners and labs, providing them support in the diagnosis of various cancers such as lung, breast, prostate and others. Currently the company has three CE-IVD marked AI models, ready to be deployed in laboratories and hospitals.

"We believe that AI and digital solutions are the future of cancer diagnostics. Aiforia already has the technology and capabilities to cater to this. Our aim is to help alleviate the challenges faced by global healthcare systems, to help reduce costs, and to ultimately support pathologists in their work to improve patient outcomes and enable precision diagnostics," explains Jukka Tapaninen, CEO of Aiforia Technologies.