On September 12, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the first six months of 2019 (Press release, Innate Pharma, SEP 12, 2019, View Source [SID1234539489]). The financial statements are attached to this press release.

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"As Innate Pharma celebrates our 20th anniversary this month, we are proud to acknowledge our employees, patients, physicians, and other stakeholders who support our ambition to develop new oncology therapies for patients with high unmet medical need. We continue to deepen and mature our proprietary and partnered pipeline of assets to strengthen our broad and balanced portfolio," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We are committed to continuing to invest and execute on our corporate, clinical and commercial strategy, which has recently been strengthened by the recruitment of new executive leadership. This will support our international expansion and execute on our long-term strategy to become a rare hemato-oncology focused commercial franchise."

Webcast and conference call will be held today at 2:00pm (CEST)

Dial in numbers:

France and International: +33 (0)1 76 70 07 94 US only: +1 631 510 7495

PIN code: 5173329#

The Interim financial report, the presentation and access to the live webcast will be available on Innate Pharma’s website 30 minutes ahead of the conference.

A replay will be available on Innate Pharma’s website after the conference call.

Financial highlights of the first half of 2019:

The key elements of Innate Pharma’s financial position and financial results as of and for the six-month period ended June 30, 2019 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €200.3m** as of June 30, 2019 (€202.7m as of December 31, 2018), including non-current financial instruments amounting to €35.3m (€35.2m as of December 31, 2018). This follows receipt in January of €108.8m as the second and final payment associated with the signature of the agreement signed with AstraZeneca in October 2018, as well as the payment of $50m (or €43.8m) to AstraZeneca in relation to Lumoxiti agreement and additional considerations relating to monalizumab and anti-CD39, paid to Novo Nordisk A/S and Orega Biotech, for $15m (or €13.1m) and €7.0m, respectively.
As of June 30, 2019, financial liabilities amounted to €5.0m compared to €4.5m as of December 31, 2018.
Revenue and other income of €59.2m for the six-month period ended June 30, 2019, as compared to €23.0m for the first half of 2018, restated, of which €51.6m result from revenue from collaboration and licensing agreements and €7.6m from research tax credit.

Revenue from collaboration and licensing agreements mainly result from to the spreading of the upfront payment from the agreements signed with AstraZeneca in April 2015 and October 2018, based on the completion of the work the Company is engaged to perform (€24.3m for monalizumab and €22.5m for IPH5201).
Operating expenses of €45.9m compared to €37.9m for the first half of 2018, restated, of which 80% are related to research and development (R&D).
R&D expenses increased by €4.3m to €36.6m for the six month period ended June 30, 2019, as compared to €32.3m for the first half of 2018. This increase mainly results from an increase of €4.2m in amortization of intangible assets.
General and administrative (G&A) expenses increased by €3.7m to €9.3m for the six-month period ended June 30, 2019 as compared to €5.6m for the first half of 2018. This increase mainly results from the increase in non-scientific advisory expenses relating to fees incurred in connection with a potential capital raising activity.
A net loss of €3.8m resulted from distribution agreement in the context of the the launch of Lumoxiti in the US performed by AstraZeneca.
Net income for the first half of 2019 was €13.2m compared to a net loss of €15.1m for the first half of 2018 restated.

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 Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) reported it has launched a new generic formulation of oxycodone hydrochloride hydrate extended release tablets for sustained cancer pain treatment in Japan: Oxycodone Extended Release Tablets 5 mg, 10 mg, 20 mg and 40 mg NX "Daiichi Sankyo" (hereafter, new formulation) (Press release, Daiichi Sankyo, SEP 12, 2019, View Source [SID1234539458]).

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The new formulation of oxycodone hydrochloride, a strong opioid analgesic providing relief of moderate to severe pain in various types of cancer, contains the narcotic antagonist naloxone in order to prevent abuse.

It is manufactured from drug substance to formulation solely by Daiichi Sankyo’s subsidiary in Japan, Daiichi Sankyo Propharma Co., Ltd. (marketing authorization holder).

The addition of the new formulation to our product lineup of opioid analgesics will provide another treatment option to patients suffering from cancer pain and further enhance our contribution to healthcare in Japan.

Product Name

Therapeutic

Category

Original Brand Name

Oxycodone Extended Release Tablets 5mg NX "Daiichi Sankyo"

Oxycodone Extended Release Tablets 10mg NX "Daiichi Sankyo"

Oxycodone Extended Release Tablets 20mg NX "Daiichi Sankyo"

Oxycodone Extended Release Tablets 40mg NX "Daiichi Sankyo"

Sustained cancer

pain treatment

OxyContin TR Tablets 5 mg

OxyContin TR Tablets 10 mg

OxyContin TR Tablets 20 mg

OxyContin TR Tablets 40 mg

About Daiichi Sankyo Opioid Analgesics in Japan

Daiichi Sankyo aims to contribute to the total care of cancer patients for their lives with our opioid analgesics.

Daiichi Sankyo believes that expanding our product lineup of opioid analgesics provides support for patients living with cancer by improving their quality of life through pain relief.

Opioid analgesics sold in Japan by Daiichi Sankyo comprise the hydromorphone hydrochloride formulations Narusus Tablets (extended release formulation), Narurapid Tablets (immediate release formulation), Naruvein Injection (injection formulation), the oxycodone hydrochloride formulations Oxycodone Extended Release Tablets "Daiichi Sankyo" (extended release formulation) and Oxycodone Extended Release Tablets NX "Daiichi Sankyo" (extended release formulation) that have just been launched, Oxycodone Tablets "Daiichi Sankyo" (extended release formulation) and Oxycodone Injections "Daiichi Sankyo"(injection formulation) as well as the fentanyl citrate tape formulation Fetanyl Citrate Tape for 1 day "Daiichi Sankyo" (transdermal absorption formulation).

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 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.