On July 23, 2019 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the pricing of an underwritten public offering of (i) 9,200,000 shares of common stock together with common stock warrants (the "common warrants") to purchase 6,900,000 shares of common stock and (ii) 13,656,000 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with common warrants to purchase 10,242,000 shares of common stock (Press release, Advaxis, JUL 23, 2019, View Source [SID1234537664]). The shares of common stock (or pre-funded warrants, as applicable) and accompanying common warrants are being sold together at a combined public offering price of $0.70 per share. The pre-funded warrants are immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. For each pre-funded warrant that the Company sells, the number of shares of common stock being offered will be reduced on a one-for-one basis. The common warrants will have an exercise price of $2.80 per share, will be immediately exercisable and will expire five years from the date of issuance. The common warrants also provide that if during the period of time between the date that is the earlier of (i) 30 days after issuance and (ii) if the Common Stock trades an aggregate of more than 35,000,000 shares after the pricing of this offering, and ending 15 months after issuance, the weighted-average price of common stock immediately prior to the exercise date is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock. The Company has granted the underwriters a 30-day option to purchase up to an additional 1,450,000 shares of common stock and/or 1,087,500 common warrants to cover over-allotments, if any.

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The gross offering proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants, are expected to be approximately $16 million. The offering is expected to close on or about July 25, 2019, subject to customary closing conditions.

The Company intends to use the net proceeds from this offering to fund its continued research and development initiatives in connection with its product pipeline including, but not limited to (i) investment in our ADXS- HOT program in both monotherapy and combination therapy and new cancer types; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, in combination therapy; and (iii) general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (No. 333-232526) relating to the offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective on July 22, 2019. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On July 23, 2019 OnKure, Inc., the leader in discovery and development of selective histone deacetylase inhibitors, reported that it entered into an exclusive license and option agreement with Massachusetts-based KDAc Therapeutics, Inc. to support the continued development of KDAc’s selective histone deacetylase 3 (HDAC3) inhibitor program (Press release, OnKure, JUL 23, 2019, View Source [SID1234537680]).

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The collaboration will focus on the continued advancement of KDAc’s lead candidate, KDAc-0001 (or OKI-422), which is licensed from the Broad Institute of MIT and Harvard. Histone deacetylase (HDAC) inhibitors are a class of anti-cancer agents that play important roles in epigenetic and non-histone protein regulation, including death, apoptosis, and cell cycle arrest in cancer cells. OKI-422 is designed to enhance the therapeutic benefit of targeted anti-cancer agents, including anti-checkpoint therapies through restoration of antigen presentation in genetically defined cancers driven by histone acetyl transferase (HAT) loss of function.

"KDAc’s experienced team and collaborative efforts resulted in the development of a very unique asset," said Tony Piscopio, Ph.D., Co-founder, President and Chief Executive Officer of OnKure. Piscopio added, "We are looking forward to adding KDAc-0001 to our portfolio of first in class and best in class drug candidates."

"OnKure’s experience and proven track record in epigenetic drug development synergize with KDAc’s insights in HDAC biology and discovery of highly selective inhibitors," said Edward Holson, Ph.D., Founder, Director and Chief Scientific Officer of KDAc.

On July 23, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions, reported that based on favorable safety data in a 19-patient dose-escalation run-in study, the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Company’s Phase 3 clinical trial with trans sodium crocetinate (TSC) in inoperable glioblastoma multiforme (GBM) patients (Press release, Diffusion Pharmaceuticals, JUL 23, 2019, View Source [SID1234538535]). In addition, the DSMB has recommended that the highest dose administered, 1.5 mg/kg of TSC, be used during the adjuvant treatment period of the Phase 3 INTACT trial. The INTACT (INvestigating Tsc Against Cancerous Tumors) trial is comparing standard of care (SOC) radiation therapy and chemotherapy plus TSC against SOC alone.

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The dose-escalation run-in study explored four doses of TSC: 0.25, 0.5, 1.0 and 1.5 mg/kg. Patients received SOC radiation therapy and temozolomide chemotherapy with an intravenous injection of TSC administered before those treatments. Adverse events seen were consistent with the natural history of newly diagnosed inoperable GBM patients.

The DSMB concluded that no adverse safety signal had been observed, and unanimously recommended continuing the study as planned using the 1.5 mg/kg dose of TSC during the adjuvant chemotherapy period.

"We are pleased this run-in study is consistent with our previous findings as to the safety of TSC," said David Kalergis, Diffusion’s chief executive officer. "We are hopeful these run-in safety data, along with compelling data from our Phase 2 study showing a nearly four-fold improvement in survival at two years with TSC when used with radiation therapy in the inoperable GBM patient subgroup, will attract the attention of potential partners for continuing the development of the GBM indication. GBM patients have a poor prognosis and limited treatment options. We believe TSC has great potential to improve these patients’ outcomes and extend survival."

About the INTACT Trial

The INTACT clinical trial is an open-label, randomized, controlled, Phase 3 safety and efficacy registration trial in inoperable GBM patients. It will screen 300 patients and enroll 264, with the expectation that results from 236 patients will be available for analysis. Enrolled patients will be randomized in a 1:1 ratio into control and treatment groups. Patients in the control group will receive SOC radiation and chemotherapy, including the standard temozolomide injections. Patients in the treatment group will receive injections of TSC prior to these SOC treatments. The SOC regimen for GBM is temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest, followed by 6 cycles of high-dose temozolomide treatment.

The study will compare overall survival at two years between the two groups. Up to 100 clinical sites are expected to participate.

Further details about the trial protocol are available at www.clinicaltrials.gov.

On July 23, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its second quarter 2019 financial results on Tuesday, August 6, 2019 (Press release, BioCryst Pharmaceuticals, JUL 23, 2019, View Source [SID1234537665]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 8954869. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 8954869.

On July 23, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will present at the 39th Annual Canaccord Genuity Growth Conference at 10:30 a.m. ET on Wednesday, August 7, 2019 in Boston, MA (Press release, AngioDynamics, JUL 23, 2019, View Source [SID1234537681]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.