On January 24, 2019 PharmaMar (PHM:MSE) reported that the Committee for Orphan Medicinal Products (COMP), from the EMA, has given its positive opinion for the approval of Orphan Drug status to Zepsyre (lurbinectedin) for the treatment of small-cell lung cancer (Press release, PharmaMar, JAN 24, 2019, View Source [SID1234532892]).

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Small-cell lung cancer is PharmaMar’s current priority research area. Zepsyre (lurbinectedin) is at the Phase III investigational stage, with its ATLANTIS study for the treatment of this type of tumour. PharmaMar finalised recruitment in July 2018, and hopes to have the final data on overall survival during the second half of 2019.

PharmaMar expects to release the Zepsyre (lurbinectedin) Phase II monotherapy data for relapsed small-cell lung cancer in the first half of 2019 and to submit it for presentation it at a future medical meeting.

Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction

On January 24, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares representing up to approximately 10% (the "Offer Shares") of the outstanding share capital of the company (the "Private Placement") (Press release, Nordic Nanovector, JAN 24, 2019, View Source [SID1234553484]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and Joint Bookrunners (the "Joint Global Coordinators"), and Kempen & Co N.V. is acting as Joint Bookrunner (together with the Joint Global Coordinators, the "Joint Bookrunners") in connection with the Private Placement.

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Nordic Nanovector intends to use the net proceeds of the Private Placement for the following purposes:

Manufacturing development activities (including Process Validation studies) for Betalutin
A scale-up of the Company’s clinical and commercial activities in preparation for a commercial launch of Betalutin
General corporate purposes
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CET and will close at 08:00 hours CET on 25 January 2019 (the "Application Period"). The Company and the Joint Bookrunners reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors at its sole discretion, following advice from the Joint Bookrunners.

The Offer Shares to be issued in connection with the Private Placement will be issued based on the board authorisation granted at the Company’s annual general meeting on 30 May 2018. In line with the shareholders’ approval, pre-emption rights of the existing shareholders are excluded.

The board of directors of the Company has considered alternative structures for the raising of new equity. Following careful considerations, the board of directors is of the view that the conduct of a private placement because this will, inter alia, strengthen the Company’s shareholder base in future equity raisings. Furthermore, by structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner in a market that is open for capital raisings, and with a lower discount to current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to broad marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved.

The board of directors therefore considers a private placement to be in the best interests of the Company and its shareholders.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 25 January 2019 through a notification to be issued by the Joint Bookrunners.

The Offer Shares will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Joint Bookrunners), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis. The Offer Shares delivered to the subscribers will thus be tradable from allocation. The Joint Bookrunners will settle the share loan with new shares in the Company to be issued by the Board of Directors pursuant to the abovementioned authorisation granted at the annual general meeting held on 30 May 2018.

The Company has agreed with the Joint Bookrunners to a lock-up on future share issuances, and its Board of Directors and Executive Management have all agreed with the Joint Bookrunners to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Joint Bookrunners to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 25 January 2019. Completion of the Private Placement is subject to final approval by the Company’s Board of Directors.

On January 24, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune modulating antibodies, cancer vaccines, and adoptive cell therapies1, reported the closing of its immuno-oncology (I-O) partnership deal with Gilead Sciences, Inc. (NASDAQ: GILD), focused on the development and commercialization of up to five novel immuno-oncology therapies (Press release, Agenus, JAN 24, 2019, View Source [SID1234532893]).

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Under the terms of the agreement, Agenus receives $150 million in connection with closing, which includes a $120 million upfront cash payment and a $30 million equity investment. The agreement also includes approximately $1.7 billion in potential future fees and milestones. Gilead received worldwide exclusive rights to AGEN1423. Gilead also received the exclusive option to license two additional programs: AGEN1223 and AGEN23732. Agenus has filed the IND for AGEN1223 and has a planned IND filing for AGEN2373 in the first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead also received right of first negotiation for two additional, undisclosed preclinical programs.

On January 23, 2019 Varian (NYSE: VAR) reported its first quarter fiscal year 2019 results (Filing, 8-K, Varian Medical Systems, JAN 23, 2019, View Source [SID1234532877]). All comparisons in this announcement are year-over-year, all quarter and year references are fiscal unless noted otherwise, and any references to orders are gross orders.

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(1)Non-GAAP net earnings and Non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, significant litigation charges or benefits and legal costs, significant non-recurring tax expense or benefit, and gains or losses on equity investments.

"In the first quarter, we built on the strong trajectory from last year, bringing our trailing twelve-month orders growth rate to 11%," said Dow Wilson, chief executive officer of Varian. "The team delivered exceptional performance, with accelerating software revenues and overall orders growing double-digits in each of our three geographic regions. We made progress on our strategic growth initiatives, extending our global footprint by securing Halcyon approval in China and expanding our addressable markets by signing two Noona deals with pharmaceutical companies. With a strong start to the year and tariff mitigation activities on track, we are well-positioned to deliver results within our fiscal year 2019 guidance."

The company ended the quarter with $616 million in cash and cash equivalents and no debt. Net cash provided by operating activities was $141 million, down 21% due to timing of certain accounts receivable collections and inventory build to meet demand. During the quarter, the company invested $35 million to repurchase 320,000 shares of common stock.

Oncology Systems Segment

In the first quarter, Oncology revenues totaled $702 million, up 8%. Operating earnings for the segment decreased 10%, primarily driven by the impact of tariffs.

Orders were $716 million, up 16%. Orders in the Americas increased 12%. In EMEA, orders rose 15%, the sixth consecutive quarter of double-digit growth for the region. In APAC, orders increased 25%, with accelerating growth in China.

Proton Solutions Segment

In the first quarter, Proton Solutions revenues totaled $39 million, up 32%. The company completed clinical handovers for one room each at three sites.

Non-GAAP Adjustments

Varian’s GAAP operating earnings include $22 million from the gain on the sale of the company’s equity investment in Augmenix, Inc. The company also incurred $2 million in acquisition-related expenses.

Guidance for Full Fiscal Year 2019

We are reaffirming the following guidance for fiscal year 2019:

•Revenue range of $3.06 billion to $3.15 billion, representing growth of 5% to 8%
•Non-GAAP operating earnings as a percentage of revenues range of 17.0% to 18.0%
•Non-GAAP net earnings per diluted share range of $4.60 to $4.75
•Cash flows from operations range of $460 million to $510 million

The guidance assumes a Non-GAAP effective tax rate of 21% to 22% and a weighted average diluted share count of 92 million. The guidance also assumes currency rates as of the beginning of fiscal year 2019, includes the expected net impact of all tariffs effective as of the beginning of the fiscal year, and excludes any future acquisitions.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call

Varian Medical Systems is scheduled to conduct its first quarter fiscal year 2019 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13685671. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, January 25, 2019.

On January 23, 2019 BridgeBio Pharma, a clinical-stage biopharmaceutical company focused on genetic diseases, reported a new financing round of $299.2 million (Press release, BridgeBio, JAN 23, 2019, View Source [SID1234576267]). The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors participating included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital, and Hercules Capital; and they were joined by new investors Sequoia Capital, and a blue-chip long-term investor. The financing will be used to support BridgeBio Pharma’s existing drug research and development programs and expand its efforts to rapidly develop medicines for patients with unmet needs.

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"We are privileged to be working with investors who believe in our goal of creating medicines for patients with genetic disease. We are aware that many of these patients lack effective treatment options, and we take our mission to help them seriously," said Neil Kumar, Ph.D, co-founder and chief executive officer of BridgeBio Pharma. "The path from promising early-stage science to a drug that makes a difference for patients requires a long-term vision and steady commitment. We are fortunate to have our investors’ support as we develop these treatments."

Genetic diseases are conditions that derive directly from mutations in their patients’ DNA. These mutations can be either inherited or spontaneous, and the diseases stemming from them include both Mendelian diseases, which tend to affect pediatric patients, and cancers. While there are more than 7,000 genetic diseases affecting 25 to 30 million Americans in aggregate, fewer than 500 drugs are approved for these conditions, leaving a significant number of patients without any therapeutic options.

BridgeBio Pharma was formed in 2015 by a team of drug research and development veterans from both the biotech industry and academia. The company seeks to translate novel scientific discoveries from universities, academic medical centers, and pharmaceutical research groups into genetically-targeted therapeutics that address the fundamental causes of disease. Its portfolio of more than 15 assets includes several in the pre-clinical stages of development, as well as four programs in or approaching pivotal trials.

Each of these drug assets is housed in its own subsidiary company, with access to centralized resources and capabilities courtesy of a novel corporate structure developed in conjunction with Dr. Andrew Lo of MIT’s Sloan School of Management. BridgeBio employs a lean, capital-efficient model that harnesses a central research and development platform to simultaneously operate multiple programs that fit the company’s stringent science criteria. Using this model, personnel and funding can be efficiently redistributed amongst the assets on an as-needed basis. The portfolio assets span therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. Some of the specific indications targeted include transthyretin amyloidosis (ATTR-CM and ATTR-PN), pantothenate kinase-associated neurodegeneration (PKAN), Gorlin syndrome and frequent basal cell carcinomas, dystrophic epidermolysis bullosa (DEB), Darier and Hailey-Hailey diseases, Netherton syndrome, venous malformations, Canavan disease, Leber’s hereditary optic neuropathy, molybdenum cofactor deficiency Type A, achondroplasia, and FGFR, SHP-2, and K-RAS-driven cancers.