On November 25, 2020 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT)("Lixte" or the "Company"), reported the pricing of its underwritten public offering of 1,200,000 units of securities at an offering price of $4.75 per unit (Press release, Lixte Biotechnology, NOV 25, 2020, View Source [SID1234571844]). Each unit is immediately separable into one share of common stock and one warrant to purchase one share of common stock and will be issued separately. The warrants underlying the units are immediately exercisable for one share of common stock at an exercise price of $5.70 and expire 5 years from the date of issuance.

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The Company’s common stock and warrants will begin trading on the Nasdaq Capital Market on November 25, 2020, under the symbols "LIXT" and "LIXTW," respectively. In connection with the offering, the Company effectuated a reverse split of its issued and outstanding common stock at a ratio of 1-for-6. The reverse stock split became effective at 4:00 p.m., Eastern Time, on Thursday, November 19, 2020. The share numbers and pricing information in this release are adjusted to reflect the impact of the reverse stock split.

The Company has granted the underwriters a 45-day option to purchase up to 180,000 additional shares of the Company’s common stock and/or up to 180,000 additional warrants to purchase shares of the Company’s common stock, or any combination thereof, to cover overallotments, if any. The offering is expected to close on or about November 30, 2020, subject to customary closing conditions.

The Company expects to receive gross proceeds of $5.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses and before any exercise of the underwriters’ overallotment option. The Company intends to use the net proceeds to fund its planned clinical trials, manufacturing its product candidate, maintain and extend its patent portfolio, retention of contract research organizations, development of a form of its primary compound, LB-100 for oral administration, and for working capital and other general corporate purposes.

WestPark Capital, Inc. and WallachBeth Capital, LLC are acting as the joint book-running managers for the offering.

This offering is being made pursuant to an effective registration statement on Form S-1 (No. 333-248588) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 24, 2020. A final prospectus describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, via the SEC’s website at www.sec.gov or from: WestPark Capital, Inc. – Attention: Jason Stern, 1900 Avenue of the Stars, 3rd Floor, Los Angeles, CA 90077 or by Email: [email protected] or by telephone at (310) 203-2919.

Source: Lixte Biotechnology Holdings, Inc. November 25, 2020 08:30 ET

This press release does 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On November 25, 2020, Inspyr Therapeutics, Inc. (the "Company") entered into a conversion price adjustment agreement (the "Agreement") with Sabby Healthcare Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. (collectively, "Sabby") (Filing, 8-K, Inspyr Therapeutics, NOV 25, 2020, View Source [SID1234571843]). Pursuant to the Agreement, approximately $2,383,150 in outstanding senior convertible debentures (the "Debentures") held by Sabby were amended such that their conversion prices into common stock ("Common Stock") of the Company are equal to the lesser of (i) $0.33 and (ii) 85% of the lowest volume-weighted average price during the five trading days immediately prior to the date of conversion.

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On November 25, 2020 Novavax Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported that it will participate in two upcoming investor conferences (Press release, Novavax, NOV 25, 2020, View Source [SID1234571791]). Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

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Piper Sandler 32nd Annual Virtual Healthcare Conference
Panel
Date:
Tuesday, December 1, 2020
Time: 10:00 a.m. Eastern Time (ET)
Panel title: The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
Moderators: Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
NVAX Panelist: Gregory M. Glenn, M.D., President of Research and Development, Novavax
Additional panelists: Moderna, Inc., Arcturus Therapeutics Holdings, Inc. and Altimmune, Inc.
This event is open to Piper Sandler clients

Conference
Event:
Participants: Fireside chat
Stanley C. Erck, President and Chief Executive Officer, and Dr. Glenn
Webcast:
A replay of the recorded fireside session is available through the events page of the Company’s website at ir.novavax.com for 90 days.

Event:
Date:

Investor meetings
Wednesday, December 2, 2020
Evercore ISI 3rd Annual HealthCONx Conference
Date: Thursday, December 3, 2020
Time: 2:15 p.m. Eastern Time (ET)
Participation: Fireside chat and investor meetings
Live webcast: www.novavax.com, "Investors"/ "Events"

About NVX-CoV2373

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

On November 25, 2020 UniSA researchers reported are partnering with Spanish pharmaceutical company Almirall through its open innovation platform, AlmirallShare, to further the development of new ways of treating common skin cancers (Press release, University of South Australia, NOV 25, 2020, View Source [SID1234571779]).

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UniSA researchers from its Future Industries Institute, Professor Tarl Prow and Dr Miko Yamada, will be working in collaboration with others to further their research into the causes and potential treatments for one of the most common forms of skin cancer, squamous cell carcinoma.

The research will help to unpack the molecular mechanism underlying this type of skin cancer and modulate its development with the novel use of an off-patent topical drug, proved effective in clinical trials funded by the Skin Cancer College of Australasia conducted by the UniSA FII team.

Prof Prow says joining forces with Almirall could be a game changer.

"This this collaboration will allow us to establish synergies between different groups to further our commitment to fighting skin cancer," Prof Prow says.

"By pairing our deep knowledge of a common type of skin tumor with Almirall’s leading expertise in medical dermatology we could reimagine the treatment options for people with skin carcinoma.

"This group has a strong commitment to fight skin cancer and has developed innovative technologies with clinical applications and enhanced delivery of topical drugs.

"Our team is excited to be working with them on such a significant project."

Launched in 2017, AlmirallShare aims to facilitate collaborations in dermatological research and accelerate the generation of new treatments for skin conditions, by putting together the science and creativity of experts around the world with Almirall’s own expertise.

To date more than 400 research proposals have been received and globally, 900 scientific researchers have joined the group.

Australia leads the world in incidence of skin cancer with 33.6 adults in every 100,000 affected.

On November 25, 2020 RhoVac, a clinical stage company reported that the American FDA has granted Fast Track Designation to the company’s drug candidate, RV001 (Press release, RhoVac, NOV 25, 2020, View Source [SID1234571761]). Fast Track Designation is granted to investigational drugs for expedited review by the FDA, to facilitate development of drugs aimed at treating serious or life-threatening conditions and fill unmet medical needs .

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The granted Fast Track Designation means that Rhovac and RV001 are eligible for the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, provided relevant criteria are met·
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
RhoVac filed its Fast Track Designation application at the end of September, and the company is pleased to learn less than 60 days later that the FDA has granted Fast Track Designation to RhoVac’s drug candidate, RV001. The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US. The study aims to conclude in the beginning of 2022. In prostate cancer there is currently no other therapy available for patients to prevent cancer recurrence. Currently, these patients undergo only surveillance and have no access to preventive therapy. Only when patients are diagnosed with recurring and now metastatic cancer, are they again eligible for therapy such as hormone therapy. The aim of RV001 development is to ensure that fewer patients will have to experience recurring cancer and that progression is delayed in those that do. If a Proof of Concept (PoC) for the use of RV001 in prostate cancer is obtained, it is highly likely that the drug will also be tried in other cancer forms, as there is nothing prostate specific about the scientific rationale for the drug candidate per se.

RhoVac’s CEO, Anders Månsson, comments: "We are extremely pleased and proud that our drug candidate, RV001, has earned Fast Track Designation by the FDA. We obviously appreciate the benefits that this might entail in terms of access to FDA advice and an accelerated approval process. But also the fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority, obviously sends a clear signal of recognition of the drug’s potential to all our would-be partners, which is something of great importance to us."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 25-11-2020 08:20 CET.