Entry into a Material Definitive Agreement

On September 20, 2021, Lixte Biotechnology Holdings, Inc. ("we," "our" or the "Company") reported that it entered into an at-the-market sales agreement (the "Sales Agreement") with WestPark Capital, Inc. (the "Agent") pursuant to which we may offer and sell from time to time through the Agent, acting as agent, shares of our common stock, $0.0001 par value per share, having an aggregate offering price of up to $10,000,000, subject to the terms and conditions of the Agreement (Filing, 8-K, Lixte Biotechnology, SEP 20, 2021, View Source [SID1234588075]). The issuance and sale, if any, of shares of common stock through the Agent under the Sales Agreement will be will be made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-252430) (the "Registration Statement") filed with the Securities and Exchange Commission, or "SEC," on January 26, 2021, and declared effective on February 5, 2021, and are described in detail in the related base prospectus, dated February 5, 2021 and prospectus supplement, dated September 20, 2021, included as part of our Registration Statement.

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Under the sales agreement, the Agent may sell shares of our common stock by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, but not limited to, sales made directly on the Nasdaq Capital Market, on any other existing trading market for our common stock or to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law. The Agent has agreed in the sales agreement to use its commercially reasonable efforts consistent with its respective normal trading and sales practices to sell shares in accordance with our instructions (including any price, time or size limit or other customary parameters or conditions we may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement.

We have agreed to pay the Agent a commission rate of 2.5% of the gross sales price per share of any of our shares of common stock sold through the Agent under the sales agreement, and have provided the Agent with customary indemnification and contribution rights. In addition, we have agreed to reimburse certain legal expenses and filing fees incurred by the Agent in connection with the offering pursuant to the Sales Agreement, including fees and expenses of the Agent’s legal counsel not to exceed $50,000, plus certain ongoing disbursements of its legal counsel up to $1,250 per calendar quarter.

The offering of shares of our common stock pursuant to the Sales Agreement will terminate upon the earliest of (i) the sale of the maximum dollar amount of shares of common stock subject to the Sales Agreement, (ii) the termination of the Sales Agreement by us or the Agent, and (iii) the expiration of the shelf registration statement on Form S-3 (File No. 333-252430) on the third anniversary of the initial effective date of such registration statement.

A copy of the Sales Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K (this "Report") and is incorporated herein by reference. The description of the Agreement is qualified in its entirety by reference to Exhibit 10.1 to this Report.

This Report, including the exhibits filed herewith, is not an offer to sell or the solicitation of an offer to buy the shares or any other securities of the Company, nor shall there by any offer, solicitation or sale of the shares or any other securities of the Company in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

A copy of the opinion of TroyGould PC relating to the legality of the shares is filed as Exhibit 5.1 to this Report and is filed with reference to, and is hereby incorporated by reference into, the Registration Statement.

Nordic Nanovector ASA – allocation of PSUs

On September 20, 2021 The Board of Directors of Nordic Nanovector ASA ("Nordic Nanovector" or the "Company") reported that it has on 20 September 2021 decided to grant 350,000 Performance Share Units ("PSUs") to the Company’s new CEO and primary insider Mr. Erik Skullerud in accordance with the authorisation granted at the Annual General Meeting held on 28 April 2021 (the "AGM") (Press release, Nordic Nanovector, SEP 20, 2021, View Source;allocation-of-psus-301380251.html [SID1234588073]).

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The terms and conditions of the PSUs, which are part of the Company’s long-term incentive plan for employees, are described on pages 25-27 in the Company’s annual report for 2020.

The PSUs are granted without consideration. The PSUs are non-transferable and will vest three years after the date of grant subject to satisfaction of the applicable vesting conditions. Each vested PSU will give the holder the right to acquire one share in the Company at an exercise price corresponding to the par value of the shares being NOK 0.20.

In accordance with the resolution at the AGM, the PSUs are secured by a corresponding number of free-standing warrants. The sole purpose of the warrants is to ensure delivery of shares in the Company upon exercise of the PSUs. The warrants do not give the PSU holders (or the option holders) a right to subscribe for any additional shares in the Company.

Mr. Skullerud will hold 350,000 PSUs and 0 shares after the transaction.

The allocation of PSUs is in accordance with the Board of Director’s declaration on salaries and other remuneration to the senior executive management, as approved by the Company’s AGM.

Primary insider notification pursuant to the Market Abuse Regulation article 19 are attached.

Enveric Biosciences to Participate in Upcoming Investor Conferences in September 2021

On September 20, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company developing a next-generation mental health and oncology treatment clinical discovery platform for the mind and body using psychedelics and cannabinoids, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in two upcoming investor conferences (Press release, Enveric Biosciences, SEP 20, 2021, View Source [SID1234588070]):

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Maxim’s Advances in Mental Health Virtual Conference
Wednesday, September 22nd at 10:00 a.m. ET
Panel titled: Next Gen Psychedelics: Novel Chemical Entities
To attend, register here

Benzinga’s Healthcare Small Cap Virtual Conference
Thursday, September 30th at 3:40 p.m. ET
To attend, register here

For more information about the conferences, or to schedule a one-on-one meeting with Enveric’s management, please contact your appropriate representative directly, or send an email to Maxim at [email protected], Benzinga at [email protected], or KCSA Strategic Communications at [email protected].

GT BioPharma’s Next Generation Camelid TriKE® Nanobody Platform Highlighted at ESMO Congress 2021

On September 20, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported Dr. Jeffrey Miller’s mini-oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, GT Biopharma, SEP 20, 2021, View Source [SID1234588066]). Jeffrey Miller, MD is a Professor of Medicine, University of Minnesota Medical School, Division of Hematology, Oncology and Transplantation and GT Biopharma’s consulting Chief Scientific Officer.

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The presentation at ESM0 highlighted the activity of camelid TriKEs in preclinical B7H3 positive and HER2+ solid tumor cancer models. GT Biopharma plans to advance these TriKEs into the clinic in 2022. The abstract is currently available on the ESMO (Free ESMO Whitepaper) website at www.esmo.org.

In addition to the ESMO (Free ESMO Whitepaper) presentation, GT Biopharma provided an update on its ongoing Phase 1 safety and feasibility clinical trial with GTB-3550. A total of 12 relapsed/refractory acute myelogenous leukemia (AML) and high grade myelodysplastic syndromes (MDS) patients have now been administered one cycle of GTB-3550, the company’s first-generation TriKE which targets CD33 on the surface of the leukemic cells in patients with AML and MDS.

The three most recent patients (numbers 10-12) have all tolerated the treatment well. One patient at the 150 mcg/kg/day dose experienced a mild Grade 1 cytokine release syndrome (CRS) event (fever), which was not dose limiting. Immune monitoring on these three most recent patients was consistent with the data previously reported on the first nine patients, and demonstrated activation, proliferation, and persistence of CD16 positive NK cells. Patient 11 had a bi-phenotypic leukemia which co-expressed both CD19 (a lymphoid marker) and CD33 (the myeloid marker which is targeted by GTB-3550); this patient showed a 50% reduction in CD33-positive leukemic cells (blasts), evidence of anti-leukemic activity of GTB-3550. Patients 10 and 12 did not experience blast cell reduction. The Company has previously reported that three of the first nine patients experienced a reduction in blast cells.

Gregory Berk, MD, President of R&D and Chief Medical Officer of GT Biopharma commented "We are very pleased with what we have learned from the Phase 1 GTB-3550 clinical trial. The TriKE is safe and well tolerated. The TriKE results in NK cell activation, proliferation, and persistence. There are also early signs of anti-leukemic activity. We are excited to advance GT Biopharma’s next generation camelid program for this difficult-to-treat patient population."

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

CASI Pharmaceuticals, Inc. To Participate In Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

On September 20, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Dr. Alexander Zukiwski, Chief Medical Officer of CASI Pharmaceuticals, will be presenting at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, CASI Pharmaceuticals, SEP 20, 2021, View Source;medtech-summit-301379920.html [SID1234588063]). Details for the virtual conference is as follows.

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Date: Tuesday, September 21st
Time: 12:05 PM (EDT)

Webcast or external link of the company presentation will be available under "Events & Presentations" in the "Investors Relations" section of CASI’s website. Archived replays will be available for approximately 90 days following the event.