On December 13, 2019 Aethlon Medical, Inc. (Nasdaq:AEMD) (the "Company"), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported the pricing of an underwritten public offering of 3,333,334 shares of common stock (which includes pre-funded warrants to purchase shares of common stock in lieu thereof), and common warrants to purchase up to an aggregate of 3,333,334 shares of common stock at a public offering price of $1.50 per share (Press release, Aethlon Medical, DEC 13, 2019, View Source [SID1234552375]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with a common warrant to purchase one share of common stock. The common warrants have an exercise price of $1.50 per share, are immediately exercisable, and will expire five years from the date of issuance. The Company has granted the underwriter a 45-day option to purchase up to an additional 499,999 shares of common stock and/or common warrants to purchase up to 499,999 shares of common stock, at the public offering price, less underwriting discounts and commission.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses and excluding the exercise of any common warrants and the underwriter’s option to purchase additional securities. The Company intends to use approximately $700,000 of the net proceeds from this offering for the currently planned clinical trials for the Hemopurifier over the next 12 months, with the remainder for working capital and other general corporate purposes. This offering is expected to close on or about December 17, 2019, subject to customary closing conditions.

A registration statement on Form S-1 (File No. 333-234712) relating to these securities (and the shares of common stock underlying the common warrants and pre-funded warrants) was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on December 12, 2019. This offering is being made only by means of a prospectus forming part of the effective registration statement. A final prospectus relating to and describing the terms of the offering will be filed with the SEC and, when available, may be obtained for free by visiting the SEC’s website at www.sec.gov. Electronic copies of the final prospectus relating to the offering may also be obtain by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 13, 2019 Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), reported the approval from the United States Patent and Trademark Office (USPTO) for a patent covering the clinical use of a biomarker analysis to detect cancer patients ability to respond to folate-based therapy cancer treatments (Press release, Isofol Medical, DEC 13, 2019, View Source [SID1234552374]).

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The patent is valid until 2035 and extends Isofol’s patent portfolio for its lead asset arfolitixorin, the company’s drug candidate entity with the potential to increase the effectiveness of folate-based chemotherapy regimens. Arfolitixorin is currently being studied in the ongoing global Phase 3 study AGENT, in patients with metastatic colorectal cancer.

Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "We consider the patent to be of great strategic importance for Isofol. It can increase the benefit of folate-based cancer treatment by detecting patients’ ability to respond to the treatment. The patent can be applied to all types of cancer undergoing folate-based cancer treatment. It is our belief that the method can be extended to further cancer indications in the long term. Currently, we are focusing on validating arfolitixorin in our global Phase III study AGENT, in patients with metastatic colorectal cancer."

The granted patent, U.S. Patent No. 10,487,364, is directed to a method of treating cancer using a combination of an anti-cancer agent and a folate substance, such as arfolitixorin or leucovorin (LV). The patent pertains to detection of the levels of a number of biomarkers involved in folate transport and metabolism, which can predict an individual patient’s responsiveness to a conventional folate substance such as leucovorin. Following biomarker analysis, patients unresponsive to current prodrugs (LV) could be selected for treatment with arfolitixorin on the basis of the biomarker level to potentially helping increase the effectiveness of the treatment regimen used. Unlike leucovorin, which must be metabolised into MTHF in the body in order to be effective in the treatment of cancer, arfolitixorin is the active substance MTHF, which means that no metabolic activation is required and arfolitixorin consequently has the potential to achieve a more powerful antitumoural effect for all patients in combination with 5-FU treatment.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:45 CET on December 13, 2019.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On December 13, 2019 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported the closing of its previously announced underwritten public offering of 3,820,000 shares of its common stock at a public offering price of $22.25 per share (Press release, Rocket Pharmaceuticals, DEC 13, 2019, View Source [SID1234552372]). The gross proceeds to Rocket from the offering are expected to be approximately $84,995,000 million, before deducting the underwriting discounts and commissions and other offering expenses.

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Rocket intends to use the net proceeds from this offering to further fund the development of our pipeline of gene therapies for rare diseases, to support the buildout of in-house manufacturing capabilities, and for general corporate purposes.

J.P. Morgan, Cowen and Evercore ISI acted as joint-bookrunning managers for the offering. LifeSci Capital LLC acted as co-manager.

The public offering was made by Rocket pursuant to an effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A final prospectus supplement relating to and describing the terms of this offering was filed with the SEC on December 11, 2019. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926, or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 1-888-474-0200 or by e-mail at [email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 13, 2019 Susan G. Komen, the world’s leading breast cancer organization, reported the results of a clinical trial, led by Komen Scholar Dr. Bryan Schneider, that moves us closer to predicting recurrence and informing the treatment of triple negative breast cancer (TNBC) (Press release, Susan G Komen, DEC 13, 2019, View Source [SID1234552371]). The results were presented at the 2019 San Antonio Breast Cancer Symposium.

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Schneider and his colleagues conducted a clinical trial at over 25 sites that looked at circulating tumor cells (CTCs) and circulating DNA (ctDNA) from the blood to determine their effectiveness at predicting recurrence, and the prognosis for patients with TNBC. TNBC has limited treatment options and a poor prognosis for patients.

"The results showed that breast cancer recurrence could be predicted for these patients and physicians may be able to use this information in the future to identify patients who are at high risk for recurrence," Schneider said. "Through this approach, researchers can also identify patients who have an incredibly good prognosis leading to the potential for future studies focused on novel de-escalation approaches for some TNBC patients."

A key aspect of this study is that over 25% of the patients enrolled were African-American women – a population that is more likely to be diagnosed with the difficult to treat TNBC. Additionally, more than 25% of the patients enrolled were under the age of 35, which is another population disproportionally impacted by TNBC.

The results of the trial have led to a second clinical trial to refine how liquid biopsy can inform treatment for TNBC patients. "The potential promise of knowing more about your risk and options from a simple blood test is phenomenal," says Schneider.

Victoria Wolodzko, senior vice president of Mission at Susan G. Komen, added, "We have been talking about the potential of liquid biopsy for a long time and we are excited to see this technology working for breast cancer patients. We look forward to the results of the follow-up trial that will lead to better treatment strategies for TNBC patients and give physicians and patients better tools to guide precision medicine."

On December 13, 2019 Dune Medical Devices, (Alpharetta, GA), a medical device company focused on improving the effectiveness and outcome of cancer therapy through real-time tissue characterization, is presenting cutting-edge data and an expanded technology platform during the 2019 San Antonio Breast Cancer Symposium (SABCS) December 10-14 (Press release, Dune Medical Devices, DEC 13, 2019, View Source [SID1234552370]).

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Dune Medical is known primarily for its MarginProbe device for intraoperative margin assessment, shown to reduce re-excisions in breast conserving surgery by over 50%, and has been used in over 20,000 procedures.

The abstract, entitled "Feasibility of incorporating miniaturized, flexible radiofrequency (RF) sensors in a breast biopsy needle for accurate real-time characterization of benign and malignant tissue," reports on data collected at three medical facilities in Israel and will be presented by Avihai Lachman, Vice President Research & Development, Dune Medical.

It has been well established that physiologic differences between benign and malignant tissues are reflected in their electrical properties. "Access to real-time tissue properties during the biopsy procedure has the potential for increasing accuracy by enabling the most suspicious tissue to be sampled, and by providing the tissue characterization to pathology for comparison with histologic findings,” said Dr. Tanir Allweis, Director, Breast Health Center, Kaplan Medical Center, Rehovot, Israel.

The results of this feasibility study demonstrate that breast tissue can be characterized in real-time during the biopsy procedure, providing constant information on the makeup of the tissue with which the needle is in contact. With a sensitivity of 85% and a specificity of 99%, this data affirms that radiofrequency spectroscopy is applicable in a multitude of applications, leading not only to more accurate tissue sampling and diagnosis, but expanded opportunities for delivering targeted therapies in the future.

"The ability to accurately characterize tissue properties in real-time during the biopsy procedure is a game changer. Studies show that there is a 25% discordance rate for breast biopsy diagnostic interpretation, which can affect how a patient is managed. Providing physicians with the ability to sample the most suspicious tissue will ensure that the most relevant biopsy cores are retrieved, enabling the most accurate diagnosis," states Lori Chmura, Dune Medical CEO.

The development of the Smart Biopsy device was made possible through the coveted European Union Horizon 2020 research grant awarded in 2016, and the technology is currently being tested in vivo. In presenting this compelling data at SABCS, Dune Medical reaches a major milestone, marking significant achievement toward its mission to make RF spectroscopy technology available across the oncology spectrum.

The San Antonio Breast Cancer Symposium, a collaboration of the American Society for Radiation Oncology (ASTRO) and the Society of Surgical Oncology (SSO), has brought the international oncology community together to share and collaborate about the latest advancements and research in breast cancer since 1977. Dune Medical will be presenting December 13, from 5-7 pm, during Poster Session 5, Ongoing Trials, Program #OT3-04-01.