Entry into a Material Definitive Agreement

On July 15, 2021, Generex Biotechnology Corporation (the "Company") reported that it closed on a funding transaction by entering into a Securities Purchase Agreement with an investor pursuant to which the Company agreed to sell and sold a secured convertible promissory note bearing interest at 8% per annum with a 12-month maturity date (the "Note") in the aggregate principal amount of $1,085,000 (Filing, 8-K, Generex, JUL 15, 2021, View Source [SID1234585012]). The purchase price of the Note was $1,000,000 with $70,000 of principal amount represented original issue discount, along with the issuance of 705,173 shares of the Company’s common stock, as inducement shares. Pursuant to the Securities Purchase Agreement, the Company also sold to the Investor warrants to purchase up to an aggregate 904,167 shares of common stock.

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Subject to certain ownership limitations, the Note will be convertible at the option of the holder six months from the issue date into shares of the Company’s common stock at an effective conversion price of the lower of (i) $0.60 and (ii) 75% of the lowest VWAP during the 30 consecutive trading days immediately preceding the delivery of the conversion. Subject to certain ownership limitations, the warrants will be exercisable after the six-month anniversary of the initial exercise date through the fifth anniversary of issuance at an exercise price of $0.60 per share of common stock.

The conversion price of the Note and the exercise of the warrants will be subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. If the Company defaults on a timely repayment, then the conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances.

The Company is required to file a registration statement with the SEC by July 26, 2021, and have the registration statement become effective within 90 days of closing.

The Company has the right to prepay the Note at a premium after issuance. If the Note is prepaid within 60 days, the Company will pay 105% of the principal amount; if the Note is prepaid after 60 days but prior to 90 days, the Company will pay 110% of the principal amount. If the Note is prepaid after 90, the Company will pay 120% of the principal amount.

The net cash proceeds to the Company from the sale of the Note, after deducting the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, is expected to be approximately $1,000,000.

The Note, warrants, and the shares of common stock underlying the warrants, were offered privately pursuant to Rule 506 of Regulation D under the Securities Act of 1933.

Fate Therapeutics to Webcast Conference Call Reporting Second Quarter 2021 Financial Results

On July 15, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported that the Company will host a conference call and live audio webcast on Wednesday, August 4, 2021 at 5:00 p.m. ET to report its second quarter 2021 financial results and provide a corporate update (Press release, Fate Therapeutics, JUL 15, 2021, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-second-6 [SID1234584875]).

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In order to participate in the conference call, please dial 800-773-2954 (toll free) or 847-413-3731 (toll) and refer to confirmation number 50196101. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Gilead Sciences to Release Second Quarter 2021 Financial Results on Thursday, July 29, 2021

On July 15, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its second quarter 2021 financial results will be released on Thursday, July 29, after the market closes (Press release, Gilead Sciences, JUL 15, 2021, View Source [SID1234584891]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s second quarter 2021 financial results and will provide a business update .

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

Wugen Raises $172 Million to Advance Clinical Stage Memory NK Cell Platform, Progress Best-In-Class AML Program, and Initiate Multiple Solid Tumor Trials

On July 15, 2021 Wugen, Inc., a clinical stage biotechnology company developing a pipeline of off-the-shelf cell therapies, reported the completion of an oversubscribed $172 million Series B financing led by Abingworth and Tybourne Capital Management, and joined by new investors Fidelity Management & Research Company, Intermediate Capital Group (ICG), Sands Capital, Aisling Capital Management, Alexandria Venture Investments, Velosity Capital and Falcon Edge Capital (Press release, Wugen, JUL 15, 2021, View Source [SID1234584876]). Existing investors, including RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital, also participated. In connection with the financing, Bali Muralidhar, M.D., Ph.D., Managing Partner at Abingworth, Bosun Hau, Managing Director at Tybourne Capital Management, and Peter Kiener, Ph.D., Venture Partner at ICG, will join Wugen’s Board of Directors. The proceeds of the financing will support further clinical development of Wugen’s best-in-class memory natural killer (NK) cell platform and advance ongoing trials for patients with severe acute myelogenous leukemia (AML) and other oncology indications, including solid tumors. Wugen also plans to apply these proceeds to advance its broader pipeline of next-generation products into the clinic, including its allogeneic CD7-targeted CAR-T cell therapy to treat T-cell leukemia and lymphoma.

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Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen, said, "We have tremendous confidence that our off-the-shelf memory NK cell platform will give rise to a significant pipeline of highly effective and safe anti-cancer therapies. In an ongoing Phase 1/2 clinical trial, our lead product WU-NK-101 has demonstrated an impressive complete response rate in relapsed/refractory AML and we look forward to advancing into a global multi-center study later this year. In parallel, we’re also pursuing solid tumor indications both as monotherapy and in combination with antibody drugs. The rapid growth of the company could not have happened without the commitment of RiverVest Venture Partners, and in particular the vision and leadership of John McKearn as our founding CEO."

"We’re delighted to welcome these premier investors as Wugen stakeholders as we build on the significant potential for the company’s unique memory NK cell platform," said John McKearn, Ph.D., Managing Director at RiverVest Venture Partners and Chairman of the Board of Directors of Wugen. "This significant capital raise will enable Wugen to advance its off-the-shelf cell therapies to develop a broad and differentiated oncology pipeline."

Wugen’s memory NK cell platform, with enhanced tumor-killing functionality and in vivo persistence, is designed to overcome the limitations of conventional NK cell therapies. In clinical studies, WU-NK-101 was shown to be highly effective against AML, including in patients with a high burden of disease, and without causing cytokine release syndrome (CRS) or neurotoxicity.

Wugen utilizes its proprietary GMP-grade fusion molecules to manufacture and scale its memory NK cell products using cells from healthy donors. In addition, Wugen’s feeder cell-free expansion and cryopreservation method enables an off-the-shelf treatment approach, with the opportunity for streamlined global distribution and convenient outpatient dosing for cancer patients.

"We’re excited to participate in this financing round with Wugen and are confident this exceptional team will deliver on the promise of memory NK cells," added Bali Muralidhar, M.D., Ph.D., Managing Director at Abingworth. "We believe that Wugen’s strong collaborative partnership with Washington University is also a key strength, especially at the translational level, where co-founders and world-class investigators Todd Fehniger, M.D., Ph.D., John DiPersio, M.D., Ph.D., Melissa Berrien-Elliott, Ph.D., and Matt Cooper, Ph.D., who is also Wugen’s Chief Scientific Officer, provide critical support."

Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be Used as a Companion Diagnostic for TABRECTA® (capmatinib)

On July 15, 2021 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA (capmatinib) may be appropriate (Press release, Foundation Medicine, JUL 15, 2021, View Source [SID1234584892]). TABRECTA is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

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NSCLC accounts for approximately 85% of lung cancer diagnoses,[1] 3 to 4% of which are associated with METex14.[2] Today’s approval adds to the number of therapies for which both of Foundation Medicine’s FDA-approved comprehensive genomic tests are listed as companion diagnostics. FoundationOneCDx, Foundation Medicine’s tissue test, was approved as a companion diagnostic for TABRECTA in May 2020.

"For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for TABRECTA and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient."

Using a simple blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The test is now approved as a companion diagnostic for nine targeted therapies across four cancer types. TABRECTA is the second therapy for which both of Foundation Medicine’s FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.

Additionally, as a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

Foundation Medicine’s strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics.