On January 17, 2020 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 that it has entered into definitive agreements with certain institutional investors for the purchase in a registered direct offering of 1,885,378 shares of its common stock, at a purchase price per share of $2.00, priced at-the-market under Nasdaq rules (Press release, Aethlon Medical, JAN 17, 2020, View Source [SID1234553315]). Additionally, Aethlon has agreed to issue to the investors unregistered warrants to purchase up to 942,689 shares of common stock. The warrants have an exercise price of $2.75 per share of common stock, will be exercisable immediately and will expire five and one-half years from the issuance date.

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The closing of the offering is expected to occur on or about January 22, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Aethlon, before deducting placement agent fees and other offering expenses, are expected to be approximately $3.77 million. The Company intends to use the net proceeds from this offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Aethlon pursuant to a "shelf" registration statement on Form S-3 that was originally filed on May 10, 2019 and declared effective by the Securities and Exchange Commission ("SEC") on August 1, 2019 and the base prospectus contained therein (File No. 333-231397). The offering of the shares of common stock is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 January 17, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Blueprint Medicines Corporation as a very limited distribution partner for breakthrough drug AYVAKIT (avapritinib) (Press release, Blueprint Medicines, JAN 17, 2020, View Source [SID1234553314]). It has been approved for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. With nationwide distribution of AYVAKIT, PANTHERx establishes a formidable presence in the precision oncology space.

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"PANTHERx is thrilled to be chosen by Blueprint Medicines to collectively make historic strides in precision oncology," said Dr. Gordon Vanscoy, Chairman and CEO of PANTHERx. "As a partner, we are grateful to offer hope to a genomically defined population of patients with rare gastrointestinal stromal tumors. PANTHERx is proud to be part of an elite network advancing precision oncology and bringing new hope to rare cancer patients."

AYVAKIT is a potent and selective KIT and PDGFRA inhibitor. It is the only FDA-approved type 1 inhibitor for GIST that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. AYVAKIT has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies.

The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced systemic mastocytosis (SM), including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

For more information about PANTHERx RxARECARE services for patients with GIST, contact us at 833-918-2015.

Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumors (GISTs) are a rare form of cancer located in the gastrointestinal (GI) tract. More than half of GISTs start in the stomach although many start in the small intestine and other parts of the GI tract. Doctors will look at specific features of a GIST to help predict whether it is likely to grow and spread to other parts of the body. GISTs are evaluated based on the size of the tumor, where it is located in the GI tract, and how fast the tumor cells are dividing (mitotic rate).

The GIST tumors often grow into empty spaces inside the GI tract so they may not cause symptoms until they reach a certain size or are in a certain location. As a result, a small tumor may not cause any symptoms. Common symptoms of GISTs include: include throwing up bright red or dark blood, bleeding into the stool, abdominal pain, a noticeable mass or swelling in the abdomen, nausea or vomiting, loss of appetite and weight loss, and feeling full after eating small amounts of food.

Treatment options depend on a several factors, including the tumor size, the mitotic rate, where the tumor is located in the GI tract, the genetic makeup of the tumor, and if the tumor has spread to other parts of the body. Treatment options include surgery to remove the tumor and targeted therapies with tyrosine kinase inhibitors (TKIs).

For more information about the symptoms, diagnosis, and treatment of Gastrointestinal Stromal Tumors please click here (View Source).

About PANTHERx Rare Pharmacy

PANTHERx Rare Pharmacy, the nation’s only health entity with an Accredited Distinction (ACHC) in Rare Pharmacy, is headquartered in Pittsburgh, Pennsylvania. PANTHERx Rare’s mission is to transform lives by delivering medical breakthroughs, clinical excellence, and access solutions to patients afflicted with rare and devastating conditions. Every day we Define RxARE, by developing focused solutions, bold innovations, and novel clinical services associated with the life-transforming therapies that we deliver.

PANTHERx was awarded 2018 Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy. Zitter Health Insights awarded PANTHERx the Specialty Pharmacy Patient Choice Award winner for two consecutive years. As a quad-accredited pharmacy, PANTHERx holds accreditations from URAC, VIPPS, ACHC, and CPPA.

On January 17, 2019 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the agreement by several accredited investors to exercise certain warrants to purchase up to an aggregate of 5,555,554 shares of common stock having an exercise price of $2.70 issued by the company on July 30, 2019, at a reduced exercise price of $1.36 per share, priced at-the-market under Nasdaq rules (Press release, Seneca Biopharma, JAN 17, 2020, View Source [SID1234553313]).

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The shares of common stock issuable upon exercise of the warrants are registered pursuant to a registration statement on Form S-1 (File No. 333-232273) which became effective by the Securities and Exchange Commission (SEC) on July 25, 2019. The gross proceeds to the company from the exercise of the warrants are expected to be approximately $7.55 million, prior to deducting placement agent fees and estimated offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 5,555,554 shares of common stock, at an exercise price of $1.23 per share, 2,777,777 of which have a term of exercise equal to two years and 2,777,777 of which have a term of exercise equal to five years.

Seneca intends to use the net proceeds from the offering as working capital for general business purposes, including continued development of SNCA’s stem cell assets and seeking partnership opportunities, as well as pursuing the in-licensing or acquisition of new innovative medicines to strengthen SNCA’s pipeline.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall 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 offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On January 17, 2020 The University of California, Riverside, reported that it has received a $2.2 million grant from the National Cancer Institute of the National Institutes of Health that will help researchers target critical oncogenes of the B-cell lymphoma 2, or Bcl-2, family of proteins that regulate all major mechanisms of cell death, or "apoptosis (Press release, The University of Southern California, JAN 17, 2020, View Source;ddo011620.php [SID1234553308])."

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The Bcl-2 family of proteins, which either promote or inhibit apoptosis, provide useful targets for drug discovery because they contribute to cancers when their expression and function are altered.

"We plan to explore new avenues to target the oncogenes Mcl-1 and Bfl-1 in this family," said Maurizio Pellecchia, a professor of biomedical sciences in the UCR School of Medicine and the principal investigator of the five-year grant. "These genes are expressed in most solid tumors, including those linked to melanoma and lung cancers. These genes render these cancers resistant to chemotherapy, radiation, or even immunotherapy."

While no viable pharmacological agents or drugs have been able to target Bfl-1 to date, a few have emerged to target only Mcl-1.

Pellecchia is optimistic the research project will present several innovative drug discovery approaches that are necessary to tackle challenging drug targets such as Mcl-1 and Bfl-1.

"Our studies suggest that Bfl-1 antagonists and/or dual action Mcl-1/Bfl-1 antagonists would hold great promise for novel apoptosis-based therapies in melanoma, lung cancer, and potentially other tumors," he said. "Therapeutic options for chemotherapy resistant cancers are limited. Our studies aim at addressing this critical unmet medical need."

Pellecchia’s team will focus on deriving novel, potent, and irreversible agents that target Bfl-1, and other agents that simultaneously target both Bfl-1 and Mcl-1.

"These are challenging goals, but our preliminary data give us hope and confidence that we may succeed due, in part, to innovative drug targeting approaches we have employed," he said.

John Jefferson Perry, an assistant professor of biochemistry and co-investigator, will receive a portion of the funds to perform crystallography studies on the most promising agents derived by the research team.

"We are excited to use protein crystallography analyses to help study these novel antagonists," Perry said. "Knowledge of the antagonists’ interaction with the target can be immensely helpful in these cancer-focused structure-based drug design studies."

The project will support two project scientists and two graduate students.

On January 16, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that an abstract on new Phase 1 translational results for BPX-601, its lead GoCAR-T product candidate, has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) (Press release, Bellicum Pharmaceuticals, JAN 16, 2020, View Source [SID1234553311]). The meeting is being held January 23-25, 2020 in San Francisco.

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Details of the poster presentation are as follows:

Title: Tumor Infiltration and Cytokine Biomarkers of Prostate Stem Cell Antigen (PSCA)-Directed GoCAR-T Cells in Patients with Advanced Pancreatic Tumors
Poster Board: M1, Abstract 734
Presenter: Joanne Shaw, Ph.D.
Time/Location: Friday, January 24, 2020, 12 p.m. to 1:30 p.m., 4:30 p.m. to 5:30 p.m. PT, Level 1, West Hall