Avid Bioservices, Inc. Announces Proposed $125 Million Offering of Exchangeable Senior Notes

On March 8, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP) (the "company"), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that its wholly-owned subsidiary, Avid SPV, LLC (the "Issuer"), intends to sell, subject to market and other conditions, $125 million aggregate principal amount of exchangeable senior notes due 2026 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Avid Bioservices, MAR 8, 2021, View Source [SID1234576260]). The Issuer also intends to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $18.75 million aggregate principal amount of the notes.

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The notes will be senior, unsecured obligations of the Issuer, will be fully and unconditionally guaranteed by the company on a senior, unsecured basis, and will accrue interest payable semi-annually in arrears. The notes will mature on March 15, 2026, unless earlier repurchased, redeemed or exchanged. Holders of the notes will have the right to exchange their notes for shares of the company’s common stock in certain circumstances and during specified periods. The notes will be settled in cash, shares of the company’s common stock or a combination of cash and shares of the company’s common stock, at the Issuer’s election.

The Issuer expects to make an intercompany loan to the company of all of the net proceeds from this offering. The company intends to use a portion of such loan to pay the cost of the capped call transactions described below, and to use up to approximately $41.3 million of such loan to redeem all of the company’s outstanding 10.50% Series E Convertible Preferred Stock (assuming such redemption occurs on April 10, 2021, all such shares remain outstanding through such date and none of such shares are converted into the company’s common stock prior to such redemption). The company intends to use the remainder of such loan for working capital and other general corporate purposes. If the initial purchasers exercise their option to purchase additional notes, the Issuer expects to make an intercompany loan to the company of all of the net proceeds from the sale of additional notes, which the company intends to use to pay the cost of additional capped call transactions and for working capital and other general corporate purposes. The company may also use a portion of the net proceeds from such loans for the acquisition of, or investment in, technologies, solutions or businesses that complement the company’s business, although it has no commitments to enter into any such acquisitions or investments at this time.

In connection with the pricing of the notes, the company expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates or other financial institutions (the "option counterparties"). The capped call transactions are expected to cover, subject to customary adjustments, the number of shares of the company’s common stock that will initially underlie the notes. The capped call transactions are expected to reduce or offset the potential dilution of the company’s common stock as a result of any exchange of the notes and/or offset any potential cash payments the Issuer is required to make in excess of the principal amount of exchanged notes, as the case may be, with such reduction and/or offset subject to a cap. If the initial purchasers exercise their option to purchase additional notes, the company expects to enter into additional capped call transactions with the option counterparties.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their respective affiliates may purchase shares of the company’s common stock and/or enter into various derivative transactions with respect to the company’s common stock concurrently with, or shortly after, the pricing of the notes, including with certain investors in the notes. This activity could increase (or reduce the size of any decrease in) the market price of the company’s common stock or the notes at that time.

In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the company’s common stock and/or purchasing or selling the company’s common stock or other securities in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date for the capped call transactions, which are expected to occur during the 40 trading day period beginning on the 41st scheduled trading day prior to the maturity date of the notes). This activity could also cause or avoid an increase or decrease in the market price of the company’s common stock or the notes, which could affect the ability of noteholders to exchange the notes, and, to the extent the activity occurs during any observation period related to an exchange of notes, it could affect the number of shares of the company’s common stock and value of the consideration that holders of the notes will receive upon exchange of the notes.

Neither the notes, nor any shares of the company’s common stock potentially issuable upon exchange of the notes, have been, nor will be, registered under the Securities Act or any state securities laws and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The notes will be offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act.

Sesen Bio Submits Marketing Authorization Application to the European Medicines Agency for Vicineum™

On March 8, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Friday, March 5, 2021 the Company submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum1 for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) under the EMA’s centralized procedure (Press release, Sesen Bio, MAR 8, 2021, View Source [SID1234576243]).

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The MAA is supported by the pivotal Phase 3 VISTA trial data, which the Company believes demonstrates a strong risk-benefit profile. In addition, the Company believes the chemistry, manufacturing and controls (CMC) data confirms the analytical comparability between clinical and commercial supply.

"Europe represents one of the largest regions in terms of unmet need for patients with NMIBC," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The submission of the MAA in Europe marks an important milestone as we continue toward the goal of making this potential best-in-class treatment available to patients globally. I would like to thank the Sesen Bio team and our regulatory partners for their execution excellence and tireless dedication to help save and improve the lives of the patients we serve. We will continue working collaboratively with the EMA to move Vicineum through the regulatory process as expeditiously as possible."

In Europe, bladder cancer is the fifth most commonly diagnosed cancer with about 124,000 new cases per year, and it ranks ninth in cause of death with approximately 40,000 deaths per year. Approximately 80% of these patients are diagnosed with NMIBC, of which many will initially be treated with BCG and at least 50% of patients will experience disease recurrence. If BCG is not effective or a patient can no longer receive BCG, the recommended treatment option is radical cystectomy, the complete removal of the bladder. If approved in Europe, Vicineum would be the first product approved for patients with high-risk, BCG-unresponsive NMIBC in over 20 years.

1The proprietary brand name, Vicineum is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process with the EMA for oportuzumab monatox.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk, BCG-unresponsive NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer

There are approximately 440,000 new cases of bladder cancer each year globally, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and many patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. Additionally, there is an ongoing chronic, global shortage of BCG, which puts a tremendous pressure on doctors, patients and the FDA. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

Altimmune To Present At Upcoming Conferences

On March 8, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that members of the management team will present during a fireside chat at the H.C. Wainwright Global Life Sciences Conference, being held Mar 9-10, 2021 (Press release, Altimmune, MAR 8, 2021, View Source [SID1234576332]). Also, Altimmune’s Chief Medical Officer, Dr. Scott Harris, will be giving an oral presentation at the 2021 NASH-TAG Conference, being held March 11-13, 2021.

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Details on the H.C. Wainwright fireside chat presentation are as follows:

Title: H.C. Wainwright Global Life Sciences Conference

Presenters: Vipin Garg, Ph.D., Chief Executive Officer
Scot Roberts, Ph.D., Chief Scientific Officer
Scott Harris, M.D., Chief Medical Officer

Date/Time: March 9, 2021 at 7:00 am ET

A webcast link to the H.C. Wainwright fireside chat presentation will be accessible on the Events section of the Altimmune website.

Details on the NASH-TAG 2021 presentation by Dr. Scott Harris are as follows:

Title: Dual GLP-1 Agonists in the Treatment of Metabolic
& Liver Dysfunction in NASH

Presenter: Scott Harris M.D., Chief Medical Officer

Date/Time: March 13, 2021 at 9:30 pm ET

A copy of the presentation materials will be accessible on the Events section of the Altimmune website.

Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer

On March 8, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the company is voluntarily withdrawing the US indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) (Press release, Hoffmann-La Roche, MAR 8, 2021, View Source [SID1234576174]). This decision was made in consultation with the US Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Roche will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Roche is notifying healthcare professionals about this withdrawal. Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider.

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"The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients."

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific post marketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum treated mUC indication. This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, Roche is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of mUC, in PD-L1-positive mTNBC and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

Merus to Participate in a Fireside Chat at the 33rd Annual Roth Conference

On March 8, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., Chief Executive Officer, will participate in a fireside chat at the 33rd Annual Roth Conference on Monday, March 15 at 2:00 p.m. ET (Press release, Merus, MAR 8, 2021, View Source [SID1234576245]).

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The live webcast of the presentation will be available on the Investors page of the Company’s website, View Source An archived presentation will be available on the Merus website for a limited time.