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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for the two indications of Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of the Roche Group (Press release, Foundation Medicine, JUN 9, 2022, View Source [SID1234615819]). As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine."

As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek (entrectinib). The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database currently contains more than 100,000 linked genomic profiles.

"We look forward to our ongoing partnership with Genentech and Flatiron Health as we implement this novel approach to post-approval evidence generation through our CGDB," said Sanket Agrawal, chief biopharma business officer at Foundation Medicine. "This database is an invaluable asset for cancer research, especially in rare patient populations, like ROS1-mutated NSCLC. We are well-positioned to support our biopharma partners with this unique resource as we continue accelerating access to new precision medicines."

NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all lung cancer diagnoses.1 When ROS1 gene fusions occur, generally in 1-2 percent of NSCLC diagnoses, 2 cancer cells grow and proliferate in an uncontrolled manner. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer. Though rare, occurring in roughly .3 percent of all solid tumors,3 these fusions can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.4 CGP is an important tool for identifying these rare mutations.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicine’s deep regulatory expertise. FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).

On June 9, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that they will host a webinar highlighting their RenovoTAMP therapy platform (Press release, Renovorx, JUN 9, 2022, View Source [SID1234615835]). The webinar, "Facing Today’s Challenges in Pancreatic Cancer Treatment: Understanding RenovoRx’s Trans-Arterial Micro-Perfusion Therapy Platform," will be held on Tuesday, June 21st at 8:00 am (ET). To register for this event, click here.
Speakers include Dr. Michael Pishvaian, director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs for the Johns Hopkins Kimmel Cancer Center and an associate professor at the School of Medicine, and Shaun R. Bagai, RenovoRx’s Chief Executive Officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

During the presentation, Dr. Pishvaian, who also serves as Study Chair for the Company’s Phase 3 TIGeR-PaC clinical trial, will discuss current available treatment options for pancreatic cancer and why they can fall short of providing an effective solution to fighting this deadly disease. He will also discuss how the TIGeR-PaC study is challenging this treatment paradigm by localizing the delivery of chemotherapy directly to the tumor, and how the RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform re-envisions the treatment of pancreatic and other solid tumors with the goal of improving survival and quality of life for patients undergoing chemotherapy. Dr. Pishvaian will also explain the scientific rationale underlying RenovoTAMP’s development. Mr. Bagai will conclude by talking about the Company’s plan for expanding the utility of its innovative therapy platform and its anticipated milestones for the remainder of the year. The virtual presentation will also include a Q & A session.

A recording of this presentation will be posted to the RenovoRx Website Events page when it becomes available.

On June 8, 2022 C&Cure (CEO Min Jeong-jun and Park Joong-gon), which develops a bacterial anticancer drug platform and radioactive pharmaceuticals, reported the company has completed Series B bridge investment (Press release, CNCure, JUN 8, 2022, View Source [SID1234649033]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

It has been one year since it was selected for Series A investment (KRW 6.5 billion) and investment-linked Ministry of Trade, Industry and Energy project (support amount KRW 2.5 billion) in February last year.

According to C&Cure on the 8th, existing institutional investors DT&Investment and ID Ventures made follow-up investments in the Series B bridge investment, and Hana Ventures participated as a new institutional investor.

Including the 2019 seed round (KRW 2.3 billion), the total amount raised up to this stage amounts to KRW 13 billion.

Kang Hoon-mo, an executive director at Hana Ventures who led this investment, said, "The investment point is the high research capabilities of C-level executives with world-class global competitiveness."

The funds raised will be used for the development of a bacterial anticancer drug currently underway in the United States (under contract with a US CDMO) and for the development of a radiopharmaceutical drug (in the first clinical trial underway with the Ministry of Food and Drug Safety).

The company plans to apply for an additional clinical trial of a radiopharmaceutical for the early diagnosis of malignant melanoma in the second half of this year.

C&Cure is a company established in 2019 by professors at Chonnam National University College of Medicine, and is conducting a national research project with a total budget of 8 billion won hosted by the Ministry of Trade, Industry and Energy and the Ministry of Science and ICT.

Professor Min (Department of Nuclear Medicine, photo), Professor Hong Young-jin (Microbiology), and Professor Kim Dong-yeon (College of Pharmacy, Gyeongsang National University) who are co-representatives are leading the research and development.

On June 8, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the first patient has been dosed in the expansion portion of the Phase I/II study of BT5528, Bicycle’s second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2 (Press release, Bicycle Therapeutics, JUN 8, 2022, View Source [SID1234615755]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We believe EphA2 is an attractive target for cytotoxin delivery and BT5528 has the potential to overcome the significant safety concerns seen with an antibody drug conjugate (ADC) approach to targeting EphA2," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased with the molecule’s emerging safety profile and early signs of anti-tumor activity and look forward to providing additional data from the completed Part A portion of the Phase I/II trial next quarter."

The Phase I/II multi-center, open-label trial comprises two parts: Part A, dose escalation and Part B, dose expansion. While Part A of the trial was designed to assess safety, pharmacokinetics and establish a Phase II dose, the dose expansion portion of the trial is primarily designed to assess the clinical activity of BT5528 at the recommended Phase II dose of 6.5mg/m2 every other week that was established in Part A. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on the results of the initial expansion cohorts. Dose expansion in urothelial and ovarian cancers will take place as the Company seeks to build on interim response data previously reported, as well as in a basket cohort of other solid tumors, including non-small cell lung cancer, triple-negative breast cancer, head and neck, and esophageal cancer.