8-K – Current report

On September 29, 2023 Veru Inc. (the "Company") reported that the company entered into an Amendment to Asset Purchase Agreement (the "Amendment ") with Blue Water Biotech Inc. f/k/a Blue Water Vaccines Inc. (the "Purchaser") (Filing, 8-K, Veru, SEP 29, 2023, View Source [SID1234635571]). The Amendment amends the Asset Purchase Agreement, dated as of April 19, 2023 (the "Asset Purchase Agreement"), between the Company and the Purchaser by providing that the promissory note for the $4 million installment of the purchase price due September 30, 2023, will be deemed paid and fully satisfied upon (1) the payment to the Company of the sum of $1,000,000 in immediately available funds on September 29, 2023, and (2) the issuance to the Company by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the "Series A Preferred Stock") of the Purchaser. The Company received such $1,000,000 payment on September 29, 2023.

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The terms of the Series A Purchaser Preferred Stock are governed by a Certificate of Designations filed with the Delaware Secretary of State by the Purchaser on September 29, 2023. Pursuant to the Certificate of Designations, each share of Series A Preferred Stock is convertible by the Company at any time and from time to time from and after one year from the date of issuance of the Series A Preferred Stock into that number of shares of the Purchaser’s common stock determined by dividing the Stated Value of $1,000 per share by the Conversion Price of $0.5254 per share, subject to adjustment as provided in the Certificate of Designations. The Series A Preferred Stock issued to the Company is initially convertible into an aggregate of approximately 5,709,935 shares of the Purchaser’s common stock, subject to certain shareholder approval limitations specified in the Certificate of Designations. The Purchaser has agreed in the Amendment to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023. The Series A Preferred Stock is entitled to share ratably in any dividends paid on the Purchaser’s common stock (on an as-if-converted-to-common-stock basis), has no voting rights except as to certain significant matters specified in the Certificate of Designations, and has a liquidation preference equal to the Stated Value of $1,000 per share plus any accrued but unpaid dividends thereon. The Series A Preferred Stock is redeemable in whole or in part at the Purchaser’s option at any time. The Purchaser also agreed to include the shares of common stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the Securities and Exchange Commission.

There can be no assurance as to (1) whether and when the Company will receive the future installment payments of purchase price or sales milestone payments under the Asset Purchase Agreement and the extent of the risk of a future default by the Purchaser in performing its payment obligations, (2) the ability of the Purchaser to obtain the requisite approval of its shareholders to the conversion of all of the shares of Series A Preferred Stock, and (3) whether and when the Company will be able to receive any cash proceeds from the Series A Preferred Stock, whether from sales of shares of the Purchaser’s common stock issuable upon conversion of the Series A Preferred Stock or otherwise, and the amount of any such cash proceeds.

The description of the Amendment (including the Certificate of Designations) set forth herein is qualified in its entirety by reference to the full text of the Amendment (including the Certificate of Designations), a copy of which is attached as Exhibit 10.1 hereto and incorporated by reference herein.

Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On September 29, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that it has granted equity awards on September 29, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 24 individuals hired by Sarepta in September 2023 (Press release, Sarepta Therapeutics, SEP 29, 2023, View Source [SID1234635555]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employees received, in the aggregate, options to purchase 16,575 shares of Sarepta’s common stock, and in the aggregate 8,575 restricted stock units ("RSUs"). The options have an exercise price of $121.22 per share, which is equal to the closing price of Sarepta’s common stock on September 29, 2023 (the "Grant Date"). One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of the Grant Date and thereafter 1/48th of the shares underlying each employee’s option will vest monthly, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting dates.

One-fourth of the RSUs will vest yearly on each anniversary of the Grant Date, such that the RSUs granted to each employee will be fully vested on the fourth anniversary of the Grant Date, in each case, subject to each such employee’s continued employment with Sarepta on such vesting date.

Adicet Bio Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

On September 29, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that it granted inducement awards on September 29, 2023 (Press release, Adicet Bio, SEP 29, 2023, View Source [SID1234635554]).

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Four individuals were hired by Adicet in September 2023. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 32,200 shares of Adicet’s common stock with an exercise price of $1.37 per share, the closing price of Adicet’s common stock as reported by Nasdaq on September 29, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).

Novocure Announces Presence at American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting

On September 29, 2023 Novocure (NASDAQ: NVCR) reported its participation in the upcoming American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting from October 1 – 4 in San Diego (Press release, NovoCure, SEP 29, 2023, View Source [SID1234635553]). Presentations will describe preclinical, clinical and simulation modeling studies on Tumor Treating Fields (TTFields) therapy, including new insights about methods to optimize TTFields intensities delivered at the target tumor during treatment.

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Highlights of Novocure’s poster presentations include:

a new process to identify optimized, personalized TTFields array layouts for each patient with glioblastoma (GBM) using segmentation-based treatment planning (SBTP) software

retrospective, simulated testing of SBTP to compare outputs from array layouts generated with SBTP versus array layouts generated with NovoTAL, the current standard treatment planning software, with results suggesting that SBTP-generated layouts meet established treatment thresholds for TTFields therapy, and could potentially lead to improved clinical outcomes for patients with GBM

a simulation study evaluating the effects of body mass index (BMI) on field intensities delivered to the lungs with TTFields therapy. Results support the feasibility of TTFields therapy delivery to the lungs regardless of BMI and highlight the importance of choosing the appropriate array size for each patient.
"We are committed to continuous innovation, and we look forward to sharing new insights about the use of TTFields therapy with the scientific community," said Pritesh Shah, Novocure’s Chief Growth Officer. "By developing segmentation-based treatment planning software to optimize array placement and exploring how factors such as array size affect the delivery of TTFields therapy, we aim to advance our therapy as we pursue our mission to extend survival in some of the most aggressive forms of cancer."

Presentations on TTFields at the 2023 ASTRO Annual Meeting will include:

The Effect of Body Mass Index on Tumor Treating Fields (TTFields) Intensity Distribution in the Lungs. Presenter: Nadav Shapira. 4:45 p.m. – 6 p.m. PT on Sunday, Oct. 1.

Patient-Specific Segmentation-Based Treatment Planning vs. NovoTAL for TTFields Therapy in Glioblastoma. Presenter: Brian Berger. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Retrospective Review of the Factors Limiting Optune Initiation in GBM patients. Presenter: Luis Carranza Pena. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Tumor Treating Fields (TTFields) in the Real World for Newly Diagnosed Glioblastoma: A Survival Meta-analysis With Systematic Review. Presenter: Matthew Ballo. 10:45 a.m. – 12 p.m. PT on Monday, Oct. 2.

Compatibility of Topical Products to Manage Skin Irritation Associated With TTFields. Presenter: Narasimha Kumar Karanam. 2:30 p.m. – 3:45 p.m. PT on Tuesday, Oct. 3.

A Working TTFields Therapy Framework for Patient-Specific Segmentation-Based Treatment Planning and Dosimetry. Presenter: Brian Berger. 12:30 p.m. – 1:45 p.m. PT on Wednesday, Oct. 4.

Alternating Tumor Treating Fields Layouts for Effective Treatment of the Epigastric Region. Presenter: Nadav Shapira. 12:30 p.m. – 1:45 p.m. PT on Wednesday, Oct. 4.
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health to Unveil Wide Range of Innovative Radiation Oncology Research at the 2023 ASTRO Annual Meeting

On September 29, 2023 Physician-scientists from Rutgers Cancer Institute of New Jersey and RWJBarnabas Health reported that it will present new, novel, and expansive radiation oncology data from their clinical research program at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, to be held in San Diego from October 1-4 (Press release, Rutgers Cancer Institute of New Jersey, SEP 29, 2023, View Source [SID1234635552]). A total of 10 abstracts have been accepted, comprising clinical data and analyses that advance the understanding and use of radiation therapy in the treatment of lung, breast, pancreatic, and other cancers. Rutgers Cancer Institute and RWJBarnabas Health is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state.

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"We are excited that the physician-scientists from our health system will be presenting significant and valuable information to advance the use of radiotherapy in cancer treatment at this year’s ASTRO meeting," said Bruce Haffty, MD, MS, Chair, Radiation Oncology, Associate Vice Chancellor for Cancer Programs at Rutgers Cancer Institute of New Jersey, and System Director of Radiation Oncology at RWJBarnabas Health. "The variety and nature of the abstracts being presented speak to our team’s commitment, passion, and innovation in their quest to develop disruptive strategies to advance the use of radiation therapy in cancer treatment, improve patient outcomes and save lives. Our team of world-class cancer specialists and researchers is dedicated to advancing and refining the role of radiation therapy in cancer management to improve the lives of the patients we serve."

Highlights of accepted abstracts include the following:

Findings of an analysis to explore genetic changes in aggressive pancreatic cancer. Over 90 percent of patients with pancreatic ductal adenocarcinoma (PDA) have mutations in the gene KRAS, a major driver in PDA. The aim of this research was to investigate genomic alterations based on KRAS status and identify driver mutations with KRAS wild type.
Results of a Phase 1 study combining a methionine-restricted diet (MRD) and radiation therapy to treat human malignancy, which has never been evaluated. Methionine is an amino acid critical to cell growth and survival, the deficiency of which, while tolerated by normal cells, causes cancer cell death. An MRD also enhances radio sensitization without significant adverse events.
Results of a study to determine whether dynamic changes in tumor volume in Stage III non-small cell lung cancer treated with concurrent chemoradiation followed by immunotherapy, the standard of care, may predict patient outcomes.
The full list of presentations at this year’s ASTRO Annual Meeting follows:

Oral Presentations

Abstract and
Session No.

Title

Presentation
Date/Time

Location

Abstract 106
(Session 2)

Prognostic Impact of Mismatch Repair
Deficiency on Stage I-II Endometrioid
Endometrial Cancer Treated With
Adjuvant Radiation Therapy: A Multi-
Institutional Analysis

Sunday, October 1,
2023, from 8:10-8:17
AM PST

Room 5

Abstract 136

(Session 7)
Prognostic Significance of Pretreatment
Immune Cell Infiltration in Muscle
Invasive Bladder Cancer Treated with
Definitive Chemoradiation: Analysis of
NRG RTOG 0524 and 0712

Monday, October 2,
2023, from 8:30-8:37
AM PST

Room 4

Abstract 138
(Session 7)

Comprehensive Genomic Analysis
Stratified by KRAS Status in Patients with
Pancreatic Adenocarcinoma and Its
Prognostic Significance

Monday, October 2,
2023, from 8:50-8:57
AM PST

Room 4

Abstract 1114
(QP 11)

First Results of the Primary Outcome of a
Phase II Prospective Clinical Trial to
Assess the Feasibility of Preoperative
Radiation Boost in Breast Cancer Patients

Tuesday, October 3,
2023, from
2:50-2:55 PM PST

Room 7

Abstract 280
(Session 31)

Unplanned Hospitalization and
Subsequent Mortality in Lung Cancer
Patients Undergoing Concomitant Chemo-
/Immuno-therapy and Radiotherapy: An
Analysis of Over 10,000 Patients in a
Nationwide Database

Wednesday, October
4, 2023, from 11:20-
11:27 AM PST

Room 4

Poster Presentations

Abstract and
Session No.

Title

Presentation
Date/Time

Location

Abstract 2069

(PQA 01)

Predictive Value of Dynamic Tumor
Volume Changes in Stage III Non-Small
Cell Lung Cancer treated with
Chemoradiation and Consolidative
Immunotherapy

Sunday, October 1,
2023, from 4:45-6:00
PM PST

Hal B2

Abstract 2518

(PQA 04)

The Landscape of Genetic Alterations
Associated with Metachronous Metastasis
in Patients with Pancreatic Ductal
Adenocarcinoma and Its Prognostic
significance

Monday, October 2,
2023, from 5:00-6:00
PM PST

Hall B2

Abstract 2540

(PQA 04)

Safety and Feasibility of the Addition of a
Radiosenitizing Methionine Restricted
Diet to Radiation Therapy

Monday, October 2,
2023, from 5:00-6:00
PM PST

Hall B2

Abstract 2678

(PQA 05)

Predictive Value of Tumor Volume on
Local Control in Hepatocellular
Carcinoma treated with Image Guided
Hypofractionated Radiation Treatment

Tuesday, October 3,
2023, from 12:45-2:00
PM PST

Hall B2

Abstract 3165

(PQA 08)

Pilot Study Assessing Student Interest in
Combined Residency Training Pathways
With Radiation Oncology

Tuesday, October 3,
2023, from 5:15-6:15
PM PST

Hall B2