On June 30, 2023 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported equity awards on June 30, 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 13 individuals hired by Sarepta in June 2023 (Press release, Sarepta Therapeutics, JUN 30, 2023, View Source [SID1234633011]). 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 8,950 shares of Sarepta’s common stock, and in the aggregate 8,200 restricted stock units ("RSUs"). The options have an exercise price of $114.52 per share, which is equal to the closing price of Sarepta’s common stock on June 30, 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.

On June 30, 2023 Oxcia’s CEO Ulrika Warpman Berglund reported that it has been invited to present "OXC-101: A Novel Way to Treat Acute Myeloid Leukemia by Inducing Mitotic Arrest, ROS and Oxidative Damage" at the 18th Annual Congress of International Drug Discovery Science & Technology (IDDST) conference, Amsterdam, the Netherlands, July 12-14, 2023 (Press release, Oxcia, JUN 30, 2023, View Source [SID1234633010]).

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OXC-101 is a mitotic MTH1 inhibitor, with a unique synergistic dual mechanism of action. It arrests cancer cells in mitosis by disturbing microtubule polymerization, thereby accumulating ROS which in turn generates e.g. oxidized nucleotides. By inhibiting the enzyme MTH1, OXC-101 incorporates more oxidized nucleotides into DNA resulting in DNA damage and the cancer cell dies via apoptosis and mitotic catastrophe. Hematological cancers are highly responsive to OXC-101 treatment. Importantly, OXC-101 has been demonstrated to kill primary human AML blast cells as well as chemotherapy resistant leukemic stem cells. The latter are often responsible for AML progression. OXC-101 significantly improves survival in different AML disease models and is an excellent combination partner to the standard of care treatment of AML. The preclinical data supports that OXC-101 is a promising novel anticancer agent for AML, providing rationale for the on-going clinical phase 1 trial in advanced hematological cancers. Oxcia recently obtained a Swelife/MedTech4Health grant together with Karolinska University Hospital Örebro University Hospital and Karolinska institutet to further explore the clinical benefit and safety of OXC-101 in refractory/relapsed AML patients at the recommended phase 2 dose.

The IDSST congress focuses on drug discovery, practical pharmaceutical science, clinical studies, translational medicine and new drugs in the pipeline.

On June 30, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the approval of an inducement award to one new employee, Yisrael Katz, M.D. who is joining Oncternal as VP, Clinical Development (Press release, Oncternal Therapeutics, JUN 30, 2023, View Source [SID1234633009]).

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The award will be made on July 1, 2023 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The award will consist of an option to purchase 125,000 shares of Oncternal common stock. The option will have a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The option will vest over a four-year period, with 25% of the shares subject to the option vesting on the first anniversary of the employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and will be granted as an inducement material to the employee entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4).

On June 30, 2023 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system, reported the closing of its previously announced registered direct offering for the issuance and sale of an aggregate of 578,697 of its shares of common stock (or common stock equivalents) at a purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants and concurrent private placement of an aggregate of 1,366,829 of its shares of common stock (or common stock equivalents), at the same purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants (Press release, NeuBase Therapeutics, JUN 30, 2023, View Source [SID1234633008]). In addition, the Company issued in the offerings unregistered Series A warrants to purchase up to an aggregate of 1,945,526 shares of common stock and unregistered short-term Series B warrants to purchase up to an aggregate of 1,945,526 shares of common stock. The registered direct offering and the private placement were priced at-the-market under Nasdaq rules.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings.

Each series of unregistered warrants have an exercise price $2.32 per share and are exercisable immediately upon issuance. The Series A warrants have a term of five and one-half years from the date of issuance and the short-term Series B warrants have a term of eighteen months from the date of issuance.

The gross proceeds to the Company from the concurrent offerings are approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by NeuBase. NeuBase currently intends to use the net proceeds from the offerings for working capital and general corporate purposes.

The securities offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the unregistered warrants issued in the registered direct offering) were offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-254980), including a base prospectus, previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. The offering of the securities issued in the registered direct offering was made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering have been filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the securities in the private placement and the unregistered warrants described above were made in transactions not involving a public offering and have not been registered pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities 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 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 June 30, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that the first patient was dosed in the Phase 1/2 ‘AUDREY’ trial evaluating EO4010, the Company’s third OncoMimics candidate, for the treatment of patients with unresectable, previously treated, metastatic colorectal cancer (CRC) (Press release, Enterome, JUN 30, 2023, View Source [SID1234633006]).

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EO4010 is an innovative, off-the-shelf immunotherapy that combines five synthetic OncoMimics peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the tumor-associated antigens (TAAs) BIRC5/survivin, FOXM1, UBE2C, CDC20 and KIF2C. EO4010 also includes universal cancer peptide 2 (UCP2), a helper peptide representing the CD4+ epitope.

The five selected TAAs are associated with critical cell-cycle functions and are highly expressed in CRC tumors but not significantly in healthy tissues. The selection of OncoMimics peptides corresponding to these TAAs ensures broad tumor coverage designed to overcome tumor heterogeneity and reduce tumor escape.

The AUDREY study (EOCRC2-22/NCT05589597) is a multicenter, open-label Phase 1/2 trial assessing safety, tolerability, immunogenicity and preliminary efficacy of EO4010 in monotherapy and in combination with the immune checkpoint inhibitor nivolumab for treatment of metastatic colorectal cancer. A total of 42 patients are expected to be enrolled in Europe and the US.

AUDREY represents the fourth trial investigating Enterome OncoMimics immunotherapy candidates in solid and liquid malignancies. The Company is also initiating a Phase 2 clinical study in patients with ctDNA-defined, Minimal Residual Disease of colorectal cancer, with its fourth candidate EO2040.

Dr. Romain Cohen, medical oncologist (MCU-PH) Department of medical oncology, Saint-Antoine hospital, AP-HP, and Assistant Professor of Oncology at Sorbonne University (Paris, France), is Coordinating Investigator for the AUDREY study in France. Dr. Cohen main clinical and research interests include the study of cancers harboring microsatellite instability, particularly their treatment with immune-oncology. He is principal investigator of several clinical trials dedicated to colorectal cancers.

Dr. Cohen commented, "After they have received the main standard of care treatments, patients with metastatic colorectal cancer have limited options for more efficacious treatment and as a result have poor clinical outcomes. We look forward to assessing the potential benefits of the novel immunotherapy approach of EO4010 in this frequent and underserved indication and providing updates on the progress of the AUDREY study."

Pierre Bélichard, Chief Executive Officer of Enterome, added, "This new trial evaluating EO4010 in patients with advanced disease of colorectal cancer is another significant milestone for Enterome. Building on the promising data from our ongoing trials investigating EO2401 in recurrent glioblastoma and adrenal tumors, and EO2463 in non-Hodgkin lymphoma, we believe that our upcoming studies with EO4010 and EO2040 in colorectal cancer will reinforce Enterome’s position as a leader in next-generation cancer immunotherapies. Through our OncoMimics immunotherapies, we are able to break the immune tolerance to self-antigens with a technology that is off-the-shelf and enables multi-targeting of tumor antigens. This groundbreaking approach so far demonstrates both efficacy and safety for the patients, instilling real hope in the fight against cancer."