June 9, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported the closing of its rights offering and the final results thereof (Press release, Pulse Biosciences, JUN 9, 2022, View Source [SID1234615850]).

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The Company received basic subscriptions and over-subscriptions in excess of the $15 million limit in the rights offering. Available Units were allocated proportionately among those rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under its basic subscription rights, in accordance with the procedures described in the prospectus supplement relating to the rights offering. The remaining oversubscription amounts will be returned by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent") to the investors.

The rights offering resulted in the sale of 7,317,072 units (the "Units"), at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant to purchase one share of common stock. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. 7,317,072 shares of common stock and warrants to acquire up to an additional 7,317,072 shares of common stock were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $15 million. If exercised, additional gross proceeds of up to $15 million may be received through the exercise of warrants issued in the rights offering. Each warrant is exercisable for one share of the Company’s common stock at an exercise price equal to $2.05. Warrants are exercisable immediately and expire on the fifth anniversary of the closing of the rights offering.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Shares, warrants and any excess subscription payments are expected to be distributed by the Subscription Agent on or about June 13, 2022.

After giving effect to the issuance of 7,317,072 shares of common stock in the rights offering (but excluding up to 7,317,072 shares of common stock underlying the warrants issued in the rights offering), the Company has 37,119,352 shares of common stock issued and outstanding.

The rights offering was made pursuant to the Company’s shelf registration statement on Form S-3, which became effective on August 21, 2020, the prospectus supplement dated May 4, 2022, and the prospectus supplement dated May 19, 2022, on file with the SEC containing the detailed terms of the rights offering. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on May 26, 2022, have expired.

On June 9, 2022, Moleculin Biotech, Inc. (the "Company") presented the Corporate Presentation (Press release, Moleculin, JUN 9, 2022, View Source [SID1234615849]).

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On June 9, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal ("ProSense"), reported that KTRFIOS IMPORTACAO E EXPORTACAO LTDA., IceCure’s distributor in Brazil ("KTRFIOS"), has submitted a regulatory filing to the Brazilian Health Regulatory Agency ("ANVISA") for the approval of ProSense for several indications (Press release, IceCure Medical, JUN 9, 2022, View Source [SID1234615847]). KTRFIOS has submitted this regulatory filing as part of an agreement signed with IceCure which includes KTRFIOS’ guarantee of at least $6.6 million in total sales for five years following such regulatory approval and a down payment of $344,000 for 50% of the initial order.

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The indications for use included in the ANVISA application are for oncology, including ablation of benign and malignant tissues in breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissues, as well as for palliative intervention and other indications.

According to the World Health Organization’s (WHO) Cancer Tomorrow | IARC project, Brazil had a population of over 200 million with an estimated 592,000 cancer cases in 2020, 88,500 of which were breast cancer. The WHO expects the number of breast cancer cases in Brazil to rise to 99,800 by 2025. Therefore, IceCure believes there is a clear need for minimally-invasive cancer treatments, such as ProSense, in the Brazilian market.

"We are very pleased to be working with KTRFIOS in Brazil, a significant healthcare market in Latin America, and to achieve this major milestone. This regulatory application reflects the broad number of indications for which our ProSense system can provide a highly effective, minimally invasive, and safe method of treatment for cancer patients," stated IceCure CEO Eyal Shamir. "Regulatory approvals in Brazil would add to our global regulatory landscape which now encompasses various indications across 14 countries including the U.S. and Europe."

On June 9, 2022 SOPHiA GENETICS (Nasdaq: SOPH), the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) of Barcelona, and the Spanish Diagnóstica Longwood reported from the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Vienna that they have combined their expertise to develop a new Chronic Lymphocytic Leukemia (CLL) solution to advance CLL care (Press release, Sophia Genetics, JUN 9, 2022, View Source [SID1234615846]). This collaboration will unify the wide variety of current guideline recommendations into one single application aiming to improve CLL characterization and CLL research practices in Iberia.

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SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas. The Platform computes a wide array of genomic variants needed to continually hone machine learning algorithms designed to accurately detect rare and challenging cases. The growing number of users of the SOPHiA DDM community can share and access insights by pulling the relevant signals detected from the noise, ultimately saving time and helping to make better-informed decisions.

The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis. This could lead to better detection of the disease, which accounts for 25-30% of all leukemia cases in Western countries and affects yearly more than 100,000 people globally[1], and ultimately improve patient care. Thanks to the SOPHiA DDM Platform and IDIBAPS, hematopathologists can now access guidelines for the mutational status of TP53, immunoglobulin (IG) gene rearrangements and their somatic hypermutation status, while benefitting from the identification of 23 CLL-specific genes for SNVs, InDels and CNVs including NOTCH1, SF3B1, ATM, IGLV3-21, BTK, PLCG2, BCL2, del13q14, and trisomy 12, all in one single NGS workflow.

The new CLL solution has already been used in routine in Spain, with further opportunities throughout the country, and in Latin America through Diagnóstica Longwood’s distribution channels.

"We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world. This partnership is a great example of how combining advanced data analytics with emerging CLL strategies can move the possibilities of data-driven medicine forward," said Lara Hashimoto, Chief Business Officer at SOPHiA GENETICS.

"It is a great satisfaction to see how thanks to the partnership with SOPHiA GENETICS and Diagnóstica Longwood we will be able to transfer into clinical practice the relevant information generated for so many years in the research of CLL using a simple and robust assay," said Elías Campo, principal investigator and director of IDIBAPS.

On June 9, 2022 Isotopia Molecular Imaging and the Centre for Probe Development and Commercialization (CPDC) reported that Isotopia’s technology for the production of n.c.a. Lu-177 has been successfully transferred into CPDC’s GMP facility and that CPDC has shipped its first doses of commercial n.c.a. Lu-177 (Press release, Isotopia Molecular Imaging, JUN 9, 2022, View Source [SID1234615845]).

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n.c.a. Lu-177 is currently the most commonly used radiometal for targeted radiotherapy. As the popularity of the isotope increases, the need for a constant radio-isotope supply on time is essential. Isotopia is thus adding a new production site in North America at CPDC, strengthening its global footprint in the n.c.a. Lu-177 supply chain, ensuring redundancy and shorten delivery time for global supply.

CPDC is a global leading CDMO (Contract Development and Manufacturing Organization) for the GMP manufacturing and supply of radiopharmaceuticals.

"We have successfully achieved a stable and reliable n.c.a. Lu-177 supply in North America" said Dr. Bruno Paquin, CEO of CPDC, "CPDC and Isotopia are proud to offer this unique value proposition for CPDC’s clients and beyond, empowering CPDC to become an all-encompassing radiopharmaceutical CDMO."

As a global leader specializing in radiopharmaceutical research, development, and manufacturing, Isotopia recognizes the importance of a stable and reliable supply of medical isotopes for manufacturing life-saving therapies.

Isotopia and CPDC are committed to the production of n.c.a. Lu-177, as well as collaborating on developing GMP manufacturing processes for other emerging medical isotopes.

Isotopia’s CEO & Co-Founder, Dr. Eli Shalom, stated "The CPDC manufacturing site is the first step towards Isotopia’s global footprint plan to ensure efficient production of Lu-177 and will be added to its existing Drug Master File (DMF). Together with the site in Israel and the near future site in Europe, we create full security of the product to patients on time and great value to pharma companies."

To learn more about this important milestone, come and meet us at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 annual meeting, held June 11-14, in Vancouver, BC, Canada where Isotopia Molecular Imaging and CPDC (as AtomVie Global Radiopharma Inc., the new CDMO spin-off of CPDC) will be exhibiting.