On December 10, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) ("QIAGEN") reported certain terms of the new senior, unsecured net share settled convertible bonds, which may be converted, in part, into ordinary shares of QIAGEN ("Shares"), due 2027 (the "New Bonds") and results of the invitation to sell the outstanding 0.875% convertible notes due 2021 (ISIN: XS1046477581; the "2021 Notes") (Press release, Qiagen, DEC 10, 2020, View Source [SID1234572985]).

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The New Bonds Offering

The size of the offering has been increased to $500 million aggregate principal amount. The New Bonds will be issued at 100% of their principal amount, will bear no interest and, unless previously converted, redeemed or repurchased and cancelled, will be redeemed at par value. The initial conversion price will be set at a 55% premium over the reference share price. The reference share price will be equal to the arithmetic average of the daily volume weighted average prices of the Shares on the 2 consecutive trading days commencing on December 10, 2020 on the New York Stock Exchange.

The final terms of the New Bonds will be announced following the determination of the reference share price, expected to occur post close of trading on the New York Stock Exchange on December 11, 2020.

Under the terms of the New Bonds offering, QIAGEN will agree not to sell any securities that are substantially similar to the New Bonds or its Shares for a lock-up period ending 90 days following the settlement date, subject to certain exceptions and waiver by BofA Securities, Deutsche Bank Aktiengesellschaft and Goldman Sachs International as Joint Global Coordinators.

The Invitation to Sell the 2021 Notes

As at the close of the bookbuilding process, QIAGEN announces it has agreed to purchase $172.4 million in aggregate principal amount of the outstanding 2021 Notes.

Following the completion of the repurchase, an aggregate principal amount of $4.8 million will remain outstanding.

In respect of 2021 Notes accepted for purchase, QIAGEN will pay a purchase price per 2021 Note equal to the arithmetic average of each of the daily volume weighted average prices of the Shares on the New York Stock Exchange, multiplied by the prevailing conversion ratio applicable on each such day, on the 2 consecutive trading days commencing on December 10, 2020.

On December 10, 2020 Boehringer Ingelheim reported the signing of a binding agreement for acquiring all shares of NBE-Therapeutics, a private, clinical-stage Swiss biotechnology company focused on antibody-drug conjugates and advancing targeted cancer therapies derived from its immune stimulatory iADC platform (Press release, Boehringer Ingelheim, DEC 10, 2020, View Source [SID1234572604]). NBE-Therapeutics’ lead compound NBE-002 is currently in phase I clinical studies for triple negative breast cancer and other solid tumors. Importantly, Boehringer Ingelheim gains access to an innovative and unique platform that it will use to build a leading ADC portfolio and develop potential combinations with other assets from its cancer immunology portfolio.

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"NBE-Therapeutics’ iADC platform adds exceptional tumor targeting capabilities to our oncology portfolio. Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients," said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "This acquisition is a further example of Boehringer Ingelheim’s long-term strategy to enhance our position as an innovator of novel cancer therapies for patients in need. We welcome NBE-Therapeutics’ richly talented team to Boehringer Ingelheim and we look forward to collaborating with them on this important work."

The total transaction value is 1.18 billion euros and also includes contingent clinical and regulatory milestones.

"I am extremely proud of the NBE-Therapeutics’ team and delighted that our world class ADC expertise is being recognized by Boehringer Ingelheim. This transaction is a validation of our platform and its potential for the next generation cancer therapies," said Bertrand Damour, Chief Executive Officer of NBE-Therapeutics. "We look forward to progressing NBE-002, our lead program and best-in-class anti ROR1 ADC, and to continuing the fight against cancer alongside Boehringer Ingelheim with its strong clinical development capabilities."

Boehringer Ingelheim’s cancer cell directed research is focused on the development of targeted therapies for the treatment of difficult-to-treat solid tumors. Inducing tumor cell death is a key component, and ADC based approaches have emerged as a powerful targeted therapy with potential for induction of immunogenic cell death at reduced systemic exposure and toxicity.

The NBE-Therapeutics’ acquisition will significantly strengthen Boehringer Ingelheim’s strategic focus on targeted cancer cell-directed therapies and complements existing capabilities in antigen discovery as well as antibody and T-cell engager technologies. By combining its world-class, in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative therapies and accelerating the delivery of the next generation of cancer treatments. This builds on recent strategic acquisitions and collaborations, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are also contributing assets.

NBE-Therapeutics is headquartered in Basel, Switzerland, where it was founded with financial backing from a syndicate of both corporate and institutional investors, including the Boehringer Ingelheim Venture Fund, and PPF Group, as their largest shareholders, and Denmark’s Novo Holdings. NBE-Therapeutics’ technology platform and derived assets are protected by a broad portfolio of patents and licenses.

The consummation of the transaction is subject to customary closing conditions and is expected during the course of Q1 2021.

About the ADC Platform
Antibody-drug conjugates (ADC’s) are a class of drugs that consist of an antibody that specifically binds to a target on tumor cells. The antibody is also linked to a cytotoxic drug to kill these cells. If the drug was given systemically, it would cause an unacceptable level of toxicity. However, due to the ability to now localize the drug to the tumor microenvironment using an antibody, the safety profile of the drug becomes acceptable.

NBE-Therapeutics’ proprietary technology platform creates highly potent immune stimulatory antibody-drug conjugates with an anthracycline payload, directly targeting tumor cells and inducing a long-lasting immunological anti-tumor effect. Its technology also incorporates a proprietary enzymatic conjugation step allowing for the site-specific conjugation of small molecule drugs to monoclonal antibodies overcoming liabilities related to limited serum stability and heterogeneous linkage.

About NBE-002
NBE-Therapeutics’ lead candidate, NBE-002, is an anti-ROR1 ADC. ROR1 is a receptor tyrosine kinase expressed in various hematologic and solid malignancies, including triple negative breast cancers and lung adenocarcinoma. The compound is currently in phase I clinical studies.

On December 10, 2020 Novocure (NASDAQ: NVCR) reported the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly diagnosed glioblastoma (GBM) testing the potential survival benefit of initiating Optune concurrent with radiation therapy (Press release, NovoCure, DEC 10, 2020, View Source [SID1234572620]).

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Currently, Optune with maintenance temozolomide is used to treat adults with glioblastoma, following maximal debulking surgery and completion of radiation therapy. However, preclinical studies demonstrate Tumor Treating Fields can be used synergistically with radiation therapy, due to increased tumor sensitivity to radiation therapy, further inhibiting DNA damage repair.

Trident will enroll 950 newly diagnosed GBM patients who, after surgery or biopsy, are candidates for radiation therapy and temozolomide. The experimental group will receive Optune concurrent with radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. The control group will receive radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. Patients will continue on Optune for 24 months or until second tumor progression, whichever occurs first.

"We are excited to have begun our TRIDENT trial in newly diagnosed GBM," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "The TRIDENT trial represents our commitment to extending survival for GBM patients. We look forward to our partnership with the hundreds of patients who will participate in this study, their families and caregivers, and the nearly 100 leading institutions who have committed to this important research in GBM."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells with specific membrane properties. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information

Contraindications

Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

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On December 10, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported a planned reverse stock split of its shares of common stock at a ratio of 1-for-7 (Press release, Heat Biologics, DEC 10, 2020, View Source [SID1234572605]). The reverse stock split will take effect as of 12:01 a.m. ET, December 11, 2020. Shares of Heat common stock will trade on a post-split basis on the Nasdaq Capital Market under the existing trading symbol, "HTBX," at the market open on December 11, 2020.

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Jeff Wolf, CEO of Heat, commented, "Our sole purpose in conducting this reverse-split was to address market concerns related to the Nasdaq minimum bid price requirement. Importantly, we remain in compliance with Nasdaq requirements and have important upcoming milestones related to our programs that we expect to announce soon, which we believe will further validate our strategy. It’s also important to note that we have a solid balance sheet with over $113 million of cash as of December 9, 2020."

During the Company’s special shareholder meeting held February 27, 2020, shareholders approved the Company’s reverse stock split, and granted the board of directors the authority to implement and determine the exact split ratio, which was set by the board at 1-for-7. Following the reverse stock split, the new CUSIP number will be 42237K 409, with the par value per share of common stock remaining at $0.0002. A proportionate adjustment will be made to the per-share exercise prices and number of shares issuable under all outstanding stock options and warrants.

The reverse stock split is intended to increase the market price per share of the Company’s common stock to help ensure a share price high enough to satisfy the $1.00 minimum bid price requirement by Nasdaq and to potentially increase the visibility of our company among a larger pool of institutional investors.

When the reverse stock split becomes effective, every seven shares of the Company’s issued and outstanding common stock will be combined into one share of common stock. Effecting the reverse stock split will reduce the number of issued and outstanding common stock from approximately 159.8 million shares to approximately 22.8 million. The reverse stock split will also subsequently adjust outstanding options issued under Heat’s equity incentive plan and outstanding warrants to purchase common stock.

No fractional shares will be issued in connection with the reverse stock split. Shareholders of record will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. Shareholders with shares held in certificate form will receive a Letter of Transmittal with instructions from Heat’s transfer and exchange agent, Continental Stock Transfer & Trust Company. Shareholders that hold shares in book-entry form or in brokerage accounts are not required to take any action, and will see the impact of the reverse stock split reflected in their accounts. Additionally, beneficial holders may contact their bank, broker, custodian or other nominee with questions regarding processing procedures for the reverse stock split. Additional information is available in the Form 8-K filed today with the U.S. Securities and Exchange Commission, and in the definitive proxy statement filed on January 24, 2020.