On September 12, 2019 Amgen (NASDAQ:AMGN) reported that new data from its oncology portfolio and pipeline will be presented at the 17th International Myeloma Workshop (IMW) 2019 in Boston, Sept. 12-15, 2019 (Press release, Amgen, SEP 12, 2019, View Source [SID1234539476]).

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Data featured from Amgen’s hematology franchise will include oral presentations from Phase 1 studies of AMG 420, the anti-B-cell maturation antigen (BCMA) bispecific T cell engager (BiTE) and AMG 176, the MCL-1 inhibitor in patients with relapsed or refractory multiple myeloma. Other data being presented will include safety and efficacy results of once-weekly dosing of KYPROLIS (carfilzomib) in different regimens across several patient populations, and Phase 3 results from the first KYPROLIS trial to be conducted in China.

"We are proud to build on the success of KYPROLIS and look to advance the next generation of multiple myeloma therapies through our evolving pipeline," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are excited by the initial results we have seen in our ongoing BCMA BiTE program and are focusing our efforts on the investigation of intermittent dosing paradigms that don’t involve continuous infusion. Our goal is to bring forward effective molecules that have the greatest potential to provide patient-friendly, convenient treatment options and support the healthcare professionals who fight these difficult-to-treat diseases."

A complete listing of abstracts can be found on the IMW website. Notable abstracts of interest include:

Oncology Pipeline

The Anti-BCMA Bispecific T-Cell Engager (BiTE) Molecule AMG 420 Induced MRD-Negative Complete Responses in R/R Multiple Myeloma in a FIH Study
Abstract #OAB-025, Oral Presentation, Friday, Sept. 13, at 2:30 p.m. ET in Veterans Auditorium
The Phase 1b study examining AMG 420 in patients with relapsed and/or refractory multiple myeloma is ongoing. The Company is also exploring intermittent dosing options with AMG 420 that could be evaluated following the Phase 1b study.

A Phase 1 dose escalation study of AMG 701, a half-life extended anti-BCMA BiTE molecule that can be dosed intermittently is underway with data expected for presentation in 2020.

A Phase 1, First-in-Human Study of AMG 176, a Selective MCL-1 Inhibitor, in Patients With Relapsed or Refractory Multiple Myeloma
Abstract #OAB-080, Oral Presentation, Saturday, Sept. 14, at 4 p.m. ET in Hynes Ballroom
The Phase 1 dose escalation clinical trial for AMG 397 (NCT03465540) is on a clinical hold to evaluate a safety signal for cardiac toxicity. In keeping with Amgen’s commitment to patient safety, the AMG 176 Phase 1 trial (NCT02675452) has been placed on a voluntary hold for new enrollment.

KYPROLIS

Safety and Efficacy of Once-Weekly Carfilzomib (K) Dosing in Frail Patients (pts): A Subgroup Analysis from the Phase 3 A.R.R.O.W. Study
Abstract #OAB-046, Oral Presentation, Saturday, Sept. 14, at 10:15 a.m. ET in Veterans Auditorium
Efficacy and Safety of Carfilzomib-Pomalidomide-Dexamethasone in Relapsed and/or Refractory Multiple Myeloma: Pooled Analysis of 2 Single Arm Studies
Abstract #OAB-049, Oral Presentation, Saturday, Sept. 14, at 11 a.m. ET in Veterans Auditorium
A Phase 1b Study of Once-Weekly Carfilzomib Combined with Lenalidomide and Dexamethasone (wKRd) in Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM)
Abstract #OAB-078, Oral Presentation, Saturday, Sept. 14, at 3:30 p.m. ET in Hynes Ballroom
Trial in Progress: Once-Weekly vs. Twice-Weekly Dosing of Carfilzomib-Lenalidomide-Dexamethasone in Patients w/ Relapsed or Refractory Multiple Myeloma
Abstract #SP-114, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
A Phase 3 Study of Carfilzomib and Dexamethasone (Kd) in Patients with Relapsed and Refractory Multiple Myeloma (MM) in China
Abstract #SP-115, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
A Patient-Physician Tool to Improve CoMMunication in Relapsed Refractory Multiple Myeloma (RRMM)
Abstract #SP-071, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Carfilzomib (K) in Relapsed and Refractory Multiple Myeloma (RRMM): Frailty Subgroup Analysis from Phase 3 ASPIRE and ENDEAVOR
Abstract #SP-113, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Real-World Use of Carfilzomib Therapy Among Patients with Existing Cardiovascular Medical History: An Analysis of a Prospective Observational Study
Abstract #SP-138, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Depth of Response and Outcomes by Initial Therapy Prior to Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Abstract #SP-164, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Real-World Evidence of the Use of Carfilzomib and Dexamethasone According to Age Subgroup: An Interim Analysis from a Prospective Observational Study
Abstract #SP-139, Poster Session II, Saturday, Sept. 14, from 12:30-2 p.m. ET in Hynes Auditorium
Completion of the Phase 3 CANDOR study evaluating KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone in patients with relapsed or refractory multiple myeloma is expected in the second half of 2019.

About BiTE Technology
Bispecific T cell engager (BiTE) technology is a targeted immuno-oncology platform that is designed to engage patients’ own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform leads to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

On September 12, 2019 Varian (NYSE: VAR) reported its fourth quarter fiscal year 2019 earnings release date (Press release, Varian Medical Systems, SEP 12, 2019, View Source [SID1234539475]).

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The Company will report results for the fourth quarter of fiscal year 2019 after market close on Wednesday, October 23, 2019. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415 and enter conference ID 13694509. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, October 25, 2019.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Fourth Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On September 12, 2019 Heska Corporation (Nasdaq: HSKA; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty healthcare products, reported the pricing of $75.0 million aggregate principal amount of convertible senior notes due 2026 (the "Notes") in a private offering (the "Offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Heska, SEP 12, 2019, View Source;300917636.html [SID1234539474]). In addition, the Company has granted J.P. Morgan Securities LLC and Piper Jaffray & Co., the initial purchasers of the Notes, a 13-day option to purchase up to an additional $11.25 million aggregate principal amount of the Notes, solely to cover sales in excess of the principal amount of the Notes set forth above, if any.

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The sale of the Notes to the initial purchasers is expected to settle on September 17, 2019, subject to customary closing conditions, and is expected to result in approximately $72.1 million in net proceeds to the Company (or approximately $83.0 million if the initial purchasers exercise their option to purchase additional Notes in full) after deducting the initial purchasers’ discount and estimated offering expenses payable by the Company.

The Company expects to use the net proceeds of the Offering (including from any exercise by the initial purchasers of their option to purchase additional Notes) to repay all outstanding indebtedness of approximately $12.8 million under its existing credit facility, to fully fund a $2.0 million cash collateral account contemplated to secure its obligations under its credit facility as amended in connection with the Offering, to fund its intended expansion efforts, including through acquisitions of complementary businesses or technologies or other strategic transactions, and for working capital and other general corporate purposes. From time to time, the Company evaluates and is currently evaluating potential acquisitions or other strategic transactions. The Company has no current agreements or commitments with respect to any such acquisition or strategic transaction, however, and there can be no assurance that it will be able to enter into any definitive agreements with respect to, or otherwise consummate, any such transaction.

The Notes will be senior unsecured obligations of the Company, and will bear interest at a rate of 3.750% per year. Interest will be payable semi-annually in arrears on March 15 and September 15 of each year, beginning on March 15, 2020. The Notes will mature on September 15, 2026, unless earlier converted, redeemed or repurchased. The Company may not redeem the Notes prior to September 20, 2023; on or after September 20, 2023, the Company may redeem the Notes, at its option, at a cash redemption price equal to 100% of the principal amount thereof, plus accrued and unpaid interest, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption.

Holders of the Notes will have the right to require the Company to repurchase all or a portion of their Notes upon the occurrence of a fundamental change (as defined in the indenture governing the Notes) at a cash purchase price of 100% of their principal amount plus any accrued and unpaid interest. In connection with certain corporate events, or if the Company issues a notice of redemption, the Company will, under certain circumstances, increase the conversion rate for holders who elect to exchange their Notes in connection with such corporate event or during the relevant redemption period.

The Notes will be convertible based on an initial conversion rate of 11.5434 shares of the Company’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $86.63 per share, which represents a conversion premium of approximately 35.0% to the last reported sale price of the Company’s common stock on The Nasdaq Capital Market on September 12, 2019). Prior to the close of business on the business day immediately preceding March 15, 2026, the Notes will be convertible at the option of the holders of the Notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2026 until the close of business on the business day immediately preceding the maturity date, the Notes will be convertible at the option of the holders of the Notes at any time regardless of these conditions. Conversion of the Notes will be settled in cash, shares of the Company’s common stock or a combination thereof, at the Company’s election.

The Notes will be sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The sale of the Notes and the shares of the Company’s common stock issuable upon conversion of the Notes, if any, have not been, and will not be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, the Notes and such shares, if any, may not be sold in the United States except pursuant to an applicable exemption from such registration requirements.

This press release does not constitute an offer to sell or solicitation of an offer to buy, nor shall there be any offer or sale of, the Notes (or any shares of the Company’s common stock issuable upon conversion of the Notes) in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

On September 12, 2019 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has entered into separate privately negotiated transactions to exchange approximately $86.1 million in aggregate principal amount of its 2.75% Convertible Senior Notes due 2021 (the "Existing Notes") for approximately $86.1 million in aggregate original principal amount of new 2.75% Convertible Senior Notes due 2024 (the "Exchange Notes" and such transaction, the "Exchange") together with an aggregate of approximately $6.0 million of cash (Press release, PDL BioPharma, SEP 12, 2019, View Source;300917650.html [SID1234539473]). Following the closing of the Exchange, approximately $63.9 million aggregate principal amount of Existing Notes will remain outstanding with terms unchanged. The Existing Notes and Exchange Notes hereafter referred to herein as the "Notes."

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"We are capitalizing on the strength of the convertible notes market to extend the maturity of our debt under favorable terms," said Dominique Monnet, president and CEO of PDL. "This transaction will further strengthen our balance sheet as we execute on our strategy to build a focused portfolio of actively managed operating companies with significant revenue potential."

Each $1,000 principal amount of Existing Notes will be exchanged for $1,000 original principal amount of Exchange Notes and a cash payment of $70.

The Exchange Notes will be senior, unsecured obligations of PDL and will bear interest at a rate of 2.75% per year. Interest will be payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2019. The Exchange Notes will mature on December 1, 2024, unless earlier converted, redeemed or repurchased in accordance with the terms of the Exchange Notes.

The original principal amount of the Exchange Notes will accrete at a rate of 2.375% per year commencing September 17, 2019 through the maturity date of the Exchange Notes. The accreted principal amount of the Exchange Notes is payable in cash upon maturity. However, regular cash interest payments on the Exchange Notes, and the composition of the consideration due upon their conversion, will be determined based on their original principal amount and not their accreted principal amount.

The initial conversion rate of the Exchange Notes is 262.2951 share of PDL’s common stock per $1,000 original principal amount, which is equivalent to an initial conversion price of approximately $3.81 per share of PDL’s common stock. The initial conversion price of the Exchange Notes represents a premium of approximately 61% over the last reported sale price of PDL’s common stock on the Nasdaq Global Select Market on September 12, 2019. The Exchange Notes will be convertible at the option of the holders in certain circumstances and during certain periods prior to the close of business on the business day immediately preceding June 1, 2024 or at any time beginning on June 1, 2024, until the close of business on the second scheduled trading day immediately preceding the stated maturity. Upon conversion of the Exchange Notes, holders will receive cash, shares of PDL’s common stock or a combination of cash and shares of PDL’s common stock, at PDL’s election.

Holders of the Exchange Notes will have the right, at their option, to require PDL to purchase their notes for cash if PDL undergoes a fundamental change (as defined in the indenture for the Exchange Notes), at a repurchase price equal to 100% of the accreted principal amount of the Exchange Notes on the fundamental change repurchase date, plus accrued and unpaid interest, if any, to, but excluding, such repurchase date. If a "make-whole fundamental change" (as defined in the indenture for the Exchange Notes) occurs, then, under certain circumstances, PDL will increase the conversion rate applicable to Exchange Notes converted in connection with that make-whole fundamental change.

On or after December 1, 2021 and on or before the 60th trading day before the stated maturity, PDL may redeem all or any portion of the Exchange Notes for cash, but only if the last reported sale price per share of PDL’s common stock exceeds 128% of the conversion price of the Exchange Notes for a specified period of time. The redemption price for any Exchange Notes to be redeemed will equal 100% of the accreted principal amount of such Exchange Notes on the redemption date, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.

PDL will not receive any cash proceeds from the Exchange. In return for issuing the Exchange Notes pursuant to the Exchange, PDL will receive and cancel the exchanged Existing Notes.

Piper Jaffray & Co. acted as financial advisor to PDL in connection with the Exchange.

In connection with the Exchange, PDL entered into a capped call transaction with Royal Bank of Canada (the "Counterparty" or "RBC") on similar terms and conditions as the capped call transaction entered into by PDL and Counterparty in connection with the Existing Notes (the "Existing Capped Call"). The capped call transaction is expected generally to offset potential dilution to PDL’s common stock and/or any cash payments PDL will be required to make in excess of the original principal amount upon any conversion of the Exchange Notes, with such offset subject to a cap initially equal to $4.88 per share (which represents a premium of approximately 106% over the last reported sale price of PDL’s common stock on the Nasdaq Global Select Market on September 12, 2019), subject to certain adjustments under the terms of the capped call transaction. In addition, PDL and the Counterparty entered into an agreement to terminate a portion of the Existing Capped Call, in a notional amount corresponding to the amount of Existing Notes exchanged.

PDL has been advised that, in connection with the entry into the capped call transaction, the termination of the Existing Capped Call, the partial unwinding of its hedge position with respect to the Existing Capped Call and establishing its initial hedge position with respect to the capped call transaction for the Exchange Notes, the Counterparty (and or its affiliates) expects to purchase and/or sell shares of PDL’s common stock and/or enter into various derivative transactions with respect to PDL’s common stock concurrently with or shortly after the entry into the Exchange and during any valuation period related thereto, which PDL expects to commence on the trading day immediately following the entry into the Exchange. This activity could cause or avoid an increase or decrease in the market price of PDL’s common stock or the Notes at that time. In connection with the unwinding of the Existing Capped Call, the Company expects to receive separately a payment from Counterparty in an amount that depends on the market price of the Company’s common shares over a valuation period as agreed with Counterparty.

In addition, the Counterparty may modify its hedge positions by entering into or unwinding derivatives with respect to PDL’s common stock and/or by purchasing or selling PDL’s common stock in secondary market transactions following the entry into the Exchange and any valuation period related to the establishment of its initial hedge position with respect to the capped call transaction or partial unwinding of its hedge position with respect to the Existing Capped Call (and is likely to do so during any observation period related to a conversion of Notes). This activity could also cause or avoid an increase or a decrease in the market price of PDL’s common stock or the Notes, which could affect a holder’s ability to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, could affect the amount and value of the consideration that a holder will receive upon conversion of the Notes.

On September 12, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the pricing of a global offering of 2,000,000 ordinary shares, comprised of 1,717,391 ordinary shares in the form of American Depositary Shares ("ADSs") offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the "U.S. offering"), and 282,609 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the "global offering") (Press release, Celyad, SEP 12, 2019, View Source [SID1234539471]). Each ADS represents the right to receive one ordinary share. The price per ADS was determined based on an exchange rate of $1.1008 per €1. The gross proceeds to Celyad from the global offering are expected to be approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses.

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In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions. The closing of the global offering is expected to occur on September 16, 2019, and is subject to customary closing conditions. Our ADSs and our ordinary shares are listed under the symbol "CYAD" on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited are acting as joint book-running managers for the offering. Kempen & Co U.S.A., Inc. is acting as co-manager for the offering. LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated September 10, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 10, 2019. The final prospectus supplement relating to the offering will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the accompanying prospectus and the final prospectus supplement, when available, can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email at [email protected]; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at [email protected]; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

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