Tolero Pharmaceuticals Submits Investigational New Drug Application for Experimental PKM2 Activator TP-1454

On May 19, 2020 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454 (Press release, Tolero Pharmaceuticals, MAY 19, 2020, View Source [SID1234558299]). Under this IND, Tolero intends to conduct a Phase 1/1b, first-in-human, open-label, dose‑escalation, safety, pharmacokinetic and pharmacodynamic study, which will evaluate oral TP‑1454 alone, and in combination with ipilimumab and nivolumab, in patients with advanced metastatic or progressive solid tumors.

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"The IND submission for TP-1454 represents an important step in advancing Tolero’s pipeline of innovative oncology compounds," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "TP-1454 will be the first PKM2 activator to be tested in cancer patients, representing a novel mechanism that aims to target the underlying metabolics driving tumor growth and anti-cancer immune suppression. We look forward to building our understanding of the potential role of PKM2 activation in the treatment of solid tumors."

The primary objectives of the study are to establish the safety of oral TP-1454 administered once daily as monotherapy in patients with advanced metastatic or progressive solid tumors and as combination therapy with ipilimumab and nivolumab in patients who are eligible for standard of care treatment. In addition, the study will establish the dose of TP-1454 alone and in combination with ipilimumab and nivolumab for future studies in select tumor types. Secondary objectives include assessing the pharmacokinetic profile and antitumor activity of TP-1454 alone and in combination with ipilimumab and nivolumab and evaluating proof of mechanism of TP-1454.

About TP-1454

TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, that will be evaluated in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors. TP-1454 will be the first PKM2 activator tested in cancer patients. Pyruvate kinase is the enzyme responsible for catalyzing the last step of glycolysis. PKM2 plays a critical role in the metabolic changes observed in cancer and immune cells and establishes a metabolic advantage for tumor cells over the tumor immune microenvironment.1

Nordic Nanovector ASA: Invitation to First Quarter 2020 Results Webcast

On May 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it will report its results for the first quarter 2020 on Tuesday, 26 May 2020 (Press release, Nordic Nanovector, MAY 19, 2020, View Source [SID1234558298]). A presentation by Nordic Nanovector’s senior management team will take place via a webcast at 08:30 am CET on the same day.

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A link to the webcast and a presentation will be uploaded to the company’s homepage (www.nordicnanovector.com) at 07:00 am CET on Tuesday 26 May.

VolitionRx Announces Proposed Underwritten Public Offering of Common Stock

On May 19, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company that applies its Nucleosomics platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose a range of cancers and other diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, VolitionRX, MAY 19, 2020, View Source [SID1234558297]). Volition intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the offering, to cover overallotments, if any. All shares of common stock in the offering are being offered by Volition. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NASDAQ:NHLD), is acting as sole book-running manager in connection with the offering.

Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes, including potential strategic acquisitions.

The securities described above are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227248) previously filed with and declared effective by the Securities and Exchange Commission ("SEC") on September 28, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: National Securities Corporation, 200 Vesey St., 25th Floor, New York, NY 10281, by telephone at (212) 417-3634 or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Volition has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Volition and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, 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 any such state or jurisdiction. The offering will be made only by means of a written prospectus and prospectus supplement that form part of the registration statement.

Akebia Therapeutics Announces Full Exercise of Underwriters’ Option to Purchase Additional Shares

On May 19, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that the underwriters of its previously announced public offering, which closed on May 14, 2020, have exercised in full their option to purchase an additional 1,650,000 shares of its common stock at the public offering price of $12.00 per share, less underwriting discounts and commissions (Press release, Akebia, MAY 19, 2020, View Source [SID1234558296]). After giving effect to the option closing, the total number of shares sold by the Company in the offering increased to 12,650,000 shares, which resulted in aggregate gross proceeds to the Company of approximately $151,800,000 before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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J.P. Morgan Securities LLC and Piper Sandler & Co. acted as book-running managers for the offering. BTIG, LLC and Mizuho Securities USA LLC acted as the lead managers, and H.C. Wainwright & Co., LLC acted as the co-manager for the offering.

The offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223585) previously filed with the Securities and Exchange Commission (SEC). The final prospectus supplement relating to the offering was filed with the SEC on May 12, 2020. You may obtain copies of the final prospectus supplement and the accompanying prospectus for free by visiting the SEC’s website at www.sec.gov or from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected] or Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by phone at (800) 747-3924, or by email at [email protected]. You may also get these documents for free by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

BD Announces Offerings of $1.5 billion of Common Stock and $1.5 billion of Depositary Shares Representing Interests in Mandatory Convertible Preferred Stock

On May 19, 2020 BD (Becton, Dickinson and Company) (NYSE:BDX) reported that it has commenced registered offerings of $1.5 billion of common stock, par value $1.00 per share, and $1.5 billion of depositary shares, each representing a 1/20th interest in its mandatory convertible preferred stock, par value $1.00 per share, Series B (Press release, BD Pharmaceutical Systems, MAY 19, 2020, View Source [SID1234558295]). Pursuant to the offerings, BD intends to grant the underwriters an option to purchase from BD up to an additional $225 million of common stock and up to an additional $225 million of depositary shares.

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BD intends to use the proceeds from the offerings for general corporate purposes, which may include, without limitation and in our sole discretion, funding our growth strategy through organic investments and acquisitions, working capital, capital expenditures, and repayment of outstanding indebtedness.

Each depositary share entitles the holder of such depositary share to a proportional fractional interest in the rights and preferences of the mandatory convertible preferred stock, including conversion, dividend, liquidation and voting rights, subject to the terms of the deposit agreement. Unless previously converted, on or around June 1, 2023, each then outstanding share of mandatory convertible preferred stock will automatically convert into a number of shares of BD’s common stock based on the applicable conversion rate, and each depositary share will automatically convert into a number of shares of common stock equal to a proportionate fractional interest in such shares of common stock. The conversion rates, dividend rate and other terms of the mandatory convertible preferred stock will be determined at the time of pricing of the offering of the depositary shares.

Currently, no public market exists for the depositary shares. BD intends to apply to list the depositary shares on the New York Stock Exchange under the symbol "BDXB."

The joint book-running managers for the offerings are J.P. Morgan, Barclays and Goldman Sachs & Co. LLC. You may obtain a preliminary prospectus supplement for either offering by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone (888) 603-5847, or by emailing [email protected]; and Goldman Sachs & Co. LLC, 200 West Street, New York, New York 10282-2198, Attention: Registration Department, telephone (866) 471-2526).