On April 23, 2020 Mevion Medical Systems reported that the MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) has received a Medical Device License from Health Canada, opening the door for commercial sales in Canada (Press release, Mevion Medical Systems, APR 23, 2020, View Source [SID1234556546]). The MEVION S250i is the only proton therapy system approved for use in Canada.

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!

Proton therapy is a superior form of radiation therapy that can reduce the amount of unnecessary radiation exposure to surrounding healthy tissue and sensitive organs at risk. Mevion’s HYPERSCAN Pencil Beam Scanning improves on these benefits by utilizing an adaptive multi-leaf collimator to sharpen the beam and enable a more precise and conformal dose to the tumor than ever before.

"We are pleased to achieve this important milestone toward making our cutting-edge proton therapy technology available to clinicians and patients in Canada," said James Meng, Ph.D., president of Mevion Medical Systems. "It demonstrates our dedication to take the lead and make proton therapy accessible around the world."

A recent article published in the Canadian Medical Association Journal estimates that in 2020, there will be 225,800 new cases of cancer in Canada. Many types of cancer can benefit from proton therapy, such as lung cancer (14% of all new cancer cases), breast cancer (25% of all new cancer cases in women) and prostate cancer (20% of all new cancer cases in men). Proton therapy can be especially beneficial to pediatric patients with cancers in the brain and central nervous systems, which according to the article, are the second most common cancer type, accounting for 19% of new pediatric cases.

The MEVION S250i received US FDA clearance and CE-Marking in 2017 and has been in use at leading cancer centers in the United States and Europe. Mevion’s pioneering single-room technology has allowed hospitals to successfully build and operate proton therapy centers due to its compact size, embedded clinical integration, and low-risk investment strategy. Today, new proton therapy centers in the United States are almost exclusively compact single-room systems. Mevion was the first company to innovate this new approach to proton therapy and have more systems installed and treating patients than any other compact proton therapy manufacturer in the US.

On April 23, 2020 Triple-S Management Corporation (NYSE: GTS) reported that it plans to release financial results for the first quarter ended March 31, 2020 before the market opens on Thursday, May 7, 2020 (Press release, Triple-S Management, APR 23, 2020, https://www.prnewswire.com/news-releases/triple-s-management-corporation-schedules-first-quarter-2020-earnings-release-and-conference-call-301045666.html [SID1234556562]). Roberto García-Rodríguez, President and Chief Executive Officer, and Juan José Román-Jiménez, EVP and Chief Financial Officer, will host a conference call to discuss these results at 8:30 a.m. Eastern Time.

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!

To participate on the call, please dial 1-888-204-4368 or 1-323-994-2093 at least 5 minutes before start time. The conference call will also be simulcast live on the Internet, and can be accessed by logging onto www.triplesmanagement.com.

In addition, a replay will be available through May 21, 2020 by calling 1-844-512-2921 or 1-412-317-6671 and entering replay pin number 9070409. A replay will also be available at www.triplesmanagement.com for 30 days.

On April 23, 2020, Heat Biologics, Inc. (the "Company") reported that it has entered into Amendment No. 1, dated April 23, 2020 (the "Amendment"), to that certain At Market Issuance Sales Agreement, by and between the Company and B. Riley FBR, Inc. ("B. Riley FBR") dated April 3, 2019 (together with the Amendment, the "Sales Agreement") pursuant to which the Company may offer and sell, from time to time, at its option, shares of the Company’s common stock, par value $0.0002 per share, through B. Riley FBR, as sales agent (the "Sales Agent") in an "at the market" offering (the "ATM Offering") (Filing, 8-K, Heat Biologics, APR 23, 2020, View Source [SID1234556531]). The Amendment will be effective at the time the Company’s Registration Statement on Form S-3 (File No. 333-237808) (the "New Registration Statement") is declared effective by the Securities and Exchange Commission.

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 original Sales Agreement provided for the issuance and sale of shares of common stock in the ATM Offering pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-221201)(the "Prior Registration Statement"), which includes a base prospectus and a prospectus supplement dated April 3, 2019 (the "Prior Prospectus"), providing for the sale of up to $18 million of shares of common stock in the ATM Offering. As of April 20, 2020, the Company has issued and sold an aggregate of 15,551,075 shares of common stock for aggregate gross proceeds of approximately $12,843,702 pursuant to the Sales Agreement under the Prior Registration Statement, utilizing the Prior Prospectus.

The Amendment provides for the issuance and sale of shares of common stock in the ATM Offering pursuant to the New Registration Statement. The issuance and sale of shares of common stock in the ATM Offering will be made under the New Registration Statement, once it is declared effective, pursuant to a prospectus, which consists of a base prospectus and a prospectus (the "ATM Prospectus"), each of which has been filed with the New Registration Statement. The ATM Prospectus provides for the sale of up to $50 million of shares of common stock in the ATM Offering under the New Registration Statement.

Under the terms of the Sales Agreement, in no event will the Company issue or sell through the Sales Agent such number or dollar amount of shares of common stock that would (i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed the number of authorized but unissued shares of common stock, (iii) exceed the number or dollar amount of shares of common stock permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable), or (iv) exceed the number or dollar amount of common stock for which the Company has filed a prospectus supplement to the Registration Statement.

Under the terms of the Sales Agreement, the Company may sell shares of its common stock through B. Riley FBR by any method permitted that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"). B. Riley FBR will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement. The Company will pay a commission rate of up to 3.0% of the gross sales price per share sold and agreed to reimburse B. Riley FBR for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $50,000 and have agreed to reimburse B. Riley FBR an amount not to exceed $2,500 per quarter during the term of the sales agreement for legal fees to be incurred by B. Riley FBR. The Company has also agreed pursuant to the Sales Agreement to provide B. Riley FBR with customary indemnification and contribution rights.

On April 23, 2020 Regenacy Pharmaceuticals, a clinical-stage biopharmaceutical company developing breakthrough treatments for diabetic and other peripheral neuropathies, reported the appointment of David Michelson, M.D., as Chief Medical Officer (CMO) (Press release, Regenacy Pharmaceuticals, APR 23, 2020, View Source [SID1234556547]). Dr. Michelson has served as Consultant CMO since September 2019.

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!

"I’m very pleased to officially welcome David to Regenacy’s team," said Simon Jones, Ph.D., Regenacy’s President and Chief Executive Officer. "For the past 7 months, David’s drug development expertise has been invaluable. He provided tremendous contributions and perspectives on our development strategy for ricolinostat as a consultant, and our team looks forward to continuing to work with him."

"Regenacy is pursuing a novel approach to restoring nerve function that addresses a critical unmet need of patients with peripheral neuropathy," said Dr. Michelson. "It has been a pleasure working alongside Regenacy’s tenured leadership team over the last several months and I look forward to applying my drug development experience to advance ricolinostat into the clinic for DPN."

Dr. Michelson brings over 24 years of industry experience to Regenacy. Prior to joining the company, he served as CMO for Proclara Biosciences where he oversaw multiple Phase 1 studies for a program targeting amyloidosis. Before Proclara, he worked at Merck for 11 years as the Neuroscience Therapeutic Area Head and Vice President for Clinical Development. Dr. Michelson began his career at Eli Lilly and Company, where he held positions of increasing responsibility for early and late stage drug development. Dr. Michelson earned his M.D. from the Albert Einstein College of Medicine in New York, and completed his residency in psychiatry at Yale University, where he also served as a chief resident and faculty member prior to joining the National Institute of Mental Health as a research physician.

On April 23, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin (Press release, CNS Pharmaceuticals, APR 23, 2020, View Source [SID1234556563]).

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!

Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer’s Phase 1 trial of Berubicin, 44% of the patients demonstrated a significant improvement in progression free survival. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin.

"We are excited to announce the Orphan Drug application submission for Berubicin, as it would grant special status and accelerate the development of Berubicin to treat glioblastoma, one of the world’s most aggressive forms of cancer," stated John Climaco, CEO of CNS Pharmaceuticals. "We are pleased to continue to execute upon our strategic initiatives and submit our application within the anticipated timeline outlined within our previous filings. We feel cautiously optimistic about the application, given the past Orphan Drug Designation of the molecule and positive Phase 1 results. We look forward to initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year."

The Orphan Drug Act ("ODA") provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status").

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan Drug Designation would qualify Berubicin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.