On September 3, 2021, VBI Vaccines Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC to act as the Company’s sales agent and/or principal ("Agent"), with respect to the issuance and sale of up to $125,000,000 of the Company’s common shares, no par value per share (the "Shares"), from time to time in an at-the-market public offering (Filing, 8-K, VBI Vaccines, SEP 3, 2021, View Source [SID1234587236]).

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Upon delivery of an issuance notice and subject to the terms and conditions of the Sales Agreement, Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company may sell the Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Sales Agreement, but it has no obligation to sell any of the Shares under the Sales Agreement. In addition, if expressly authorized by the Company, Agent may also sell the Shares in privately negotiated transactions.

The Company or Agent may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. Agent will use its commercially reasonable efforts consistent with its normal sales and trading practices to place the Shares, subject to the terms of the Sales Agreement. The Sales Agreement will automatically terminate when the sale of the Shares reaches an aggregate offering amount equal to $125,000,000, or sooner if terminated as permitted therein.

The Company will pay Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement.

The Sales Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Agent against certain liabilities, including liabilities under the Securities Act of 1933, as amended. A copy of the Sales Agreement is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The description of the Sales Agreement is qualified in its entirety by reference to Exhibit 1.1 to this Current Report on Form 8-K.

The Shares will be sold and issued pursuant to a shelf registration statement on Form S-3 (File No. 333-240266), which became automatically effective upon filing with the Securities and Exchange Commission on July 31, 2020, and a prospectus supplement and the accompanying prospectus relating to the at-the-market offering have been filed with the Securities and Exchange Commission on September 3, 2021.

This Current Report on Form 8-K, 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.

On September 3, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming virtual investor conferences in September (Press release, G1 Therapeutics, SEP 3, 2021, View Source [SID1234587578]).

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On September 10, 2021, G1 will participate in the Citi 16th Annual BioPharma Virtual Conference. There is no webcast associated with this conference.

On September 13, 2021, G1’s Chief Executive Officer Jack Bailey will present at the H.C. Wainwright 23rd Annual Global Investment Conference. This will be available on demand beginning the morning of September 13, 2021. The webcast will be accessible on the Events & Presentations page of View Source

On September 2, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that Bristol Myers Squibb Company (NYSE:BMY) has exercised its option to enter into an exclusive global license for EVT8683 which comes from a broader neurodegeneration collaboration (Press release, Evotec, SEP 2, 2021, View Source;announcements/press-releases/p/evotec-announces-bristol-myers-squibb-opt-in-of-evt8683-as-the-first-programme-from-ipsc-based-neurodegeneration-collaboration-6090 [SID1234587150]). EVT8683 is a small molecule targeting a key cellular stress response that holds great promise in various neurodegenerative indications and is ready to enter clinical development. The programme originated from a phenotypic screening approach based on Evotec’s leading iPSC platform and reached IND filing within only 5 years. Under an option agreement with Celgene (which is now a Bristol Myers Squibb company), Bristol Myers Squibb has rights to additional programmes in neurodegenerative diseases.

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In neurodegeneration, currently approved drugs only offer short-term management of patients’ symptoms and there is a huge unmet medical need for innovative therapies that slow down and reverse disease progression. The neurodegeneration alliance was built on Evotec’s industrialised iPSC platform using patient-derived disease models, to discover and select potentially disease-modifying approaches for neurodegenerative diseases. Evotec’s iPSC platform allows the screening of human iPSC-based disease models at high throughput in combination with unbiased transcriptome analysis. The seamless integration of the iPSC platform with Evotec’s proven small molecule discovery and development capabilities all the way to IND filing enabled the development of EVT8683 in only 5 years from a cell based phenotypic screen to successful IND filing.

Just 4.5 years after initiating the partnership, Bristol Myers Squibb has now exercised its option to enter into a global License Agreement for EVT8683. The programme targets a key cellular stress response mechanism which has the potential to deliver disease-modifying treatments for several devastating neurodegenerative diseases. Following the successful compound optimisation, the seamless integration from project initiation to IND, also using Evotec’s INDiGO platform, led to the recent registration as an Investigational New Drug ("IND") with the U.S. Food and Drug Administration ("FDA").

Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE, commented: "We are very excited to bring a first drug candidate which originated from Evotec’s iPSC discovery platform into the clinic. EVT8683 is targeting a highly promising mechanism of the cellular stress response and has already demonstrated a very compelling pre-clinical efficacy and safety profile. We are proud to continue the further clinical development of EVT8683 together with BMS’ neuroscience team, which clearly belongs to the best in the industry.

iPSC technology is only starting to deliver on its enormous potential. Developing drug candidates with convincing efficacy in disease models which have been directly derived from patients gives us hope that these next generation of drug candidates will lead to more effective drugs and thus better outcomes for patients afflicted by neurodegenerative diseases."

Dr Richard Hargreaves, Senior Vice President of Bristol Myers Squibb’s Neuroscience Thematic Research Center, added: "Entering the clinic for this innovative program marks a key step for BMS Neuroscience. Targeting one of the mechanisms which may play a key role within neurodegeneration makes us hopeful that our further development of the program may result in providing treatments for many people suffering from these devastating neurological disorders. Based on Evotec’s scientific expertise and seamless integration, we are delighted to continue development of this clinical candidate."

Through this opt-in, Bristol Myers Squibb will lead further development and commercialisation. Evotec receives an option payment of $ 20 m and is eligible to earn up to $ 250 m in milestone payments and up to low double-digit royalties.

On September 2, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that a milestone payment of $3 million from Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has been triggered as a result of the initiation of IND-enabling studies of JZP815, a preclinical Pan-RAF inhibitor, for the potential treatment of RAF driven tumours (Press release, Redx Pharma, SEP 2, 2021, View Source [SID1234587167]). Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.

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The milestone payment is due under the agreement with Jazz Pharmaceuticals announced on 10 July 2019 for Redx’s Pan-RAF inhibitor. Under the deal, Redx is entitled to up to $203 million in development, regulatory and commercial milestone payments. The Company is also eligible for royalties based on any future net sales. The next milestone payment under the agreement is due on acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). As part of a separate ongoing collaboration agreement, Jazz paid Redx to perform research and preclinical development activities to progress the programme to this stage, with the goal of completing IND-enabling studies.

The Pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs. The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours. This Pan-RAF inhibitor aims to overcome these resistance mechanisms.

Lisa Anson, Chief Executive Officer of Redx Pharma commented: "We are extremely pleased that Jazz Pharmaceuticals has initiated IND-enabling studies for the Pan-RAF inhibitor programme that Jazz acquired. The continuing success of this programme highlights, once again, Redx’s ability to generate molecules that have significant potential as novel medicines for unmet medical needs."

On September 2, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate in the Wells Fargo Virtual Healthcare Conference on Sept. 9 and the H.C. Wainwright 23rd Annual Global Investment Conference on Sept. 13 (Press release, Turning Point Therapeutics, SEP 2, 2021, View Source [SID1234587185]).

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Dr. Countouriotis is scheduled to present a company overview and participate in a question-and-answer session at 2:00 p.m. ET on Sept. 9 and present a company overview at 7:00 a.m. ET on Sept. 13. Both sessions will be accessible via webcast through the Investors page of www.tptherapeutics.com.