On July 15, 2024 Diakonos Oncology Corporation ("Diakonos"), a clinical stage immuno-oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s unique dendritic cell vaccine (DCV) for pancreatic ductal adenocarcinoma (Press release, Diakonos Oncology, JUL 15, 2024, View Source [SID1234644881]). In addition, the company has named to its Scientific Advisory Board, Daniel D. Von Hoff, M.D., Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, AZ, and City of Hope, and an experienced investigator against pancreatic cancer.

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!

"This second FDA Fast Track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgement of the incredible potential of this innovative immunotherapy for treating the most deadly cancers," said Mike Wicks, Diakonos CEO. "We are thrilled to have Dr. Von Hoff join us as an advisor as we pursue clinical development of our vaccine in this deadly disease," Mr. Wicks added. "The first designation was for our lead vaccine for glioblastoma multiforme (GBM) which successfully completed dosing for the Phase 1 trial and has significantly improved 12 month survival in those patients to well over what would be expected with the standard of care." (See the press release)

Dr. Von Hoff is an internationally recognized physician and scientist whose research has contributed to the development of many anticancer agents that are routinely used in clinical practice. His research at TGEN focuses on development of therapies for patients with advanced pancreatic cancer. He also was a founder of ILEX Oncology which was acquired by Genzyme.

In addition to his work with TGEN, Dr. Von Hoff holds the Virginia G. Piper Distinguished Chair for Innovative Cancer Research at HonorHealth Clinical Research Institute, and is Professor of Medicine at the Mayo Clinic, Scottsdale, AZ.

"Diakonos’s unique dendritic cell vaccine has shown encouraging results in treating glioblastoma, a terrible disease with few effective treatments. Pancreatic cancer patients also need additional treatment options," said Dr. Von Hoff. "I look forward to working with Diakonos to help develop effective treatments for patients with pancreatic cancer with the same targeted technology."

About FDA Fast Track:

FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions. Pancreatic ductal adenocarcinoma is the most common pancreatic cancer. It is the third leading cause of cancer deaths in the U.S. and the number of cases is growing. According to the National Institutes of Health, the average five-year survival rate is less than 13%, and in 2024 an estimated 51,750 people will die and 66,440 will be newly diagnosed.

About Diakonos’ DCV Technology:

The company’s DCVs are made with a patient’s dendritic cells and a sample of their tumor. These highly differentiated double-loaded dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that initiate a natural immune response to target and eliminate cancer cells. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches.

On July 15, 2024 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2024 after the market closes on Monday, August 5, 2024 (Press release, Akoya Biosciences, JUL 15, 2024, View Source [SID1234644865]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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!

Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

Akoya also announced that management will be presenting or doing fireside chats at two upcoming investor conferences.

Canaccord Genuity 44th Annual Growth Conference
Tuesday, August 13 at 2:30 PM ET
Morgan Stanley 22nd Annual Global Healthcare Conference
Friday, September 6 at 1:05 PM ET
A live and archived webcast of the events will be available on the "Investors" section of the Akoya website at View Source

On July 15, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its Board of Directors has authorized a share repurchase program of up to $5 million of the Company’s outstanding common stock (Press release, Anixa Biosciences, JUL 15, 2024, View Source [SID1234644866]).

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!

"This share repurchase program reflects our confidence in the future outlook of our business, the soundness of our balance sheet, the strength of our clinical development pipeline and Anixa’s long-term value. We believe that Anixa’s stock is currently undervalued and this program provides an opportunity to enhance long-term shareholder value," stated Dr. Amit Kumar, Chairman and CEO of Anixa.

Repurchases may be made from time to time at the discretion of the Board of Directors through open-market transactions in accordance with applicable securities laws. The repurchase program expires in twelve months and can be suspended or discontinued at any time. No shares have been repurchased under the program to date. There can be no assurance as to the timing or number of shares of any repurchases, if any.

On July 15, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric"), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology ("Aries"), a developer of encapsulation technologies, reported a licensing agreement for the clinical development of Enveric’s patented radiation dermatitis topical product (Press release, Enveric Biosciences, JUL 15, 2024, View Source [SID1234644868]).

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!

Radiation dermatitis is a side effect of radiation treatment that impacts roughly two million cancer patients per year and has a market opportunity estimated at $400 million annually. The formulation licensed to Aries is protected by an allowed US patent application, as well as a pending PCT application.

"This product offers the potential to provide much needed relief to cancer patients suffering from the painful side effects of radiation therapy," said Ram Lalgudi, Ph.D., CEO of Aries. "We are excited by the opportunity to advance this promising molecule to clinical trials."

Dr. Lalgudi announced: "Aries has nominated Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance this opportunity. Dr. Harikumar is a techno-commercial entrepreneur having experience with multiple companies, including his current role as VP for Performance Additives in CHASM Advanced Materials and earlier roles as CEO of QM Power, and VP, Innovation, Sustainability and Technology for Ingersoll Rand/TRANE, and President & CTO for USHA, a leading consumer brand in India. We look forward to great success under his leadership."

Joseph Tucker, Ph.D., CEO of Enveric, stated: "With its proven expertise in encapsulation solutions and strong management team, we believe Aries is the ideal partner to continue the development of this cancer support care product while Enveric sharpens its focus on neuropsychiatric indications."

Under the terms of the agreement, executed through Enveric’s subsidiary, Akos Biosciences, Inc., Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales, if all conditions are met.

On July 12, 2024 Phio Pharmaceuticals Corp., a Delaware corporation (the "Company") reported the company entered into inducement letter agreements (the "Inducement Letter Agreements") with certain holders (the "Holders") of certain of its existing warrants to purchase up to an aggregate of 545,286 shares of the Company’s common stock, $0.0001 par value (the "Common Stock"), originally issued to the Holders in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share (the "Existing Warrants") (Filing, Phio Pharmaceuticals, JUL 12, 2024, View Source [SID1234644805]).

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 shares of Common Stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (Nos. 333-239779, 333-234032, 333-238204, 333-271521, 333-272526 and 333-276146) and Form S-3 (No. 333-252588).

Pursuant to the Inducement Letter Agreements, the Holders agreed to exercise for cash the Existing Warrants at a reduced exercise price of $5.45 per share in consideration of the Company’s agreement to issue new unregistered Series C Warrants (the "Series C Warrants") to purchase up to 583,098 shares of Common Stock and new unregistered Series D Warrants (the "Series D Warrants" and, together with the Series C Warrants, the "New Warrants") to purchase up to 507,474 shares of Common Stock (collectively, the "New Warrant Shares"), issued and sold at a price of $0.125 per New Warrant. The Series C Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to five and one-half years from the date of issuance. The Series D Warrants will have an exercise price of $5.45 per share, will be exercisable immediately upon issuance and have a term equal to eighteen months from the date of issuance.

The Company has agreed to file a registration statement providing for the resale of the New Warrant Shares issuable upon the exercise of the New Warrants (the "Resale Registration Statement"), within 20 calendar days from the date of the Inducement Letter Agreements. Pursuant to the Inducement Letter Agreements, the Company agreed not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any Common Stock or Common Stock equivalents or file any registration statement or any amendment or supplement to any existing registration statement (other than the Resale Registration Statement contemplated by the Inducement Letter Agreements and described above) until the earlier of (i) a period of 90 calendar days after the closing of the offering and (ii) the day following the date that the Company’s closing price on five consecutive trading days equals or exceeds $6.50 (each of which shall be after 30 calendar days after the closing of the offering).

The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $3.1 million, prior to deducting placement agent fees and estimated offering expenses. The closing of the offering occurred on July 12, 2024.

On June 27, 2024, the Company entered into an engagement letter with H.C. Wainwright & Co., LLC ("Wainwright"), pursuant to which Wainwright agreed, among other things, to serve as the exclusive placement agent for the Company, on a reasonable best-efforts basis, in connection with the above-mentioned transaction. The Company will pay Wainwright (i) an aggregate cash fee equal to 7.5% of the gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise, and (ii) a management fee equal to 1.0% of the aggregate gross proceeds from the exercise of the Existing Warrants and, if the New Warrants are exercised for cash, upon such exercise. In connection with the above-mentioned offering, the Company also agreed to pay Wainwright $35,000 for non-accountable expenses, $50,000 for accountable expenses and $15,950 for clearing fees. Additionally, in connection with the above-mentioned offering, the Company agreed to issue to Wainwright or its designees as compensation, warrants to purchase up to 40,896 shares of Common Stock, equal to 7.5% of the aggregate number of Existing Warrants exercised in the offering and, if the New Warrants are exercised for cash, further warrants to purchase shares of Common Stock equal to the 7.5% of the aggregate number of New Warrants so exercised (the "Placement Agent Warrants"). The Placement Agent Warrants have or will have a term of five and one half years from the closing of the offering or the exercise of the New Warrants, as applicable, and an exercise price of $6.8125 per share of Common Stock.

The foregoing summaries of the Inducement Letter Agreements, the New Warrants and the Placement Agent Warrants do not purport to be complete and are subject to, and qualified in their entirety by, the forms of such documents attached as Exhibits 10.1, 4.1, and 4.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.