On March 18, 2020 MorphoSys Presents Results for Fiscal Year 2019 (Press release, MorphoSys, MAR 18, 2020, View Source [SID1234555677]).

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Conference call and webcast (in English) tomorrow, March 19, 2020 at 2:00pm CET
(1:00pm GMT/9:00am EDT)

Key pipeline and corporate development updates:

Tafasitamab (MOR208):
Priority Review for BLA submission was granted by U.S. FDA for tafasitamab in combination with lenalidomide for relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL) based on positive primary analysis data of L-MIND and Re-MIND studies
Expanded Access Program (EAP) for tafasitamab in the U.S. (initiated in February 2020)
B-MIND: Study successfully passed pre-planned, event-driven interim analysis for futility
MOR202: First clinical sites activated for MorphoSys’ phase 1/2 trial in membranous nephropathy; pivotal trials initiated by I-Mab in multiple myeloma
Otilimab (MOR103/GSK3196165): GSK initiated clinical development program in rheumatoid arthritis
Tremfya(R):
Partner Janssen submitted sBLA to U.S. FDA and marketing authorization application to EMA seeking approval of Tremfya(R) for treatment of active psoriatic arthritis
Clinical development initiated in ulcerative colitis and familial adenomatous polyposis
Jean-Paul Kress, M.D., appointed as new CEO of MorphoSys, effective September 1, 2019, following Dr. Simon Moroney’s retirement
MorphoSys’ research organization integrated into the Clinical Development segment under the lead of Dr. Malte Peters, CR&DO, following departure of Dr. Markus Enzelberger, CSO
Strengthening of U.S. presence: Opening of new U.S. headquarters in Boston; growing commercial team and progress towards launch readiness

Financial highlights:

The Company ended the financial year with revenues of €71.8 million and an EBIT of €-107.9 million
€357.4 million cash at year-end 2019 (December 31, 2018: €454.7 million)
Milestone payment of €22 million by GSK due to start of phase 3 program with otilimab
Royalties for Tremfya(R) amounted to €31.8 million; Tremfya(R) reached blockbuster status
Important subsequent event: Collaboration and licensing agreement with Incyte to further develop and commercialize tafasitamab globally (effective March 3, 2020)

The agreement secured a $750 million upfront and MorphoSys received a $150 million capital investment in new American Depositary Shares (ADS) by Incyte at a price of $41.32 per ADS (including a 20% premium on the volume-weighted average share price thirty days prior to execution of the collaboration and licensing agreement) as well as MorphoSys’ eligibility to receive potential milestone payments amounting to up to $1.1 billion; MorphoSys is also entitled to receive tiered royalties on potential ex-U.S. net sales of tafasitamab in a mid-teens to mid-twenties percentage range
MorphoSys and Incyte will co-commercialize tafasitamab in the U.S. and Incyte has exclusive commercialization rights outside of the U.S.
The agreement includes broad co-development plans for tafasitamab in r/r DLBCL, frontline DLBCL as well as additional indications beyond DLBCL, such as follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reports results for the financial year 2019 and provides a financial and operational outlook for 2020.

"The year 2019 was marked by substantial progress and great achievements. We delivered on executing our strategy and on achieving our goals for 2019 and made great strides towards bringing our first proprietary investigational product, tafasitamab, to the market in the U.S. If approved by the FDA, we are ready for tafasitamab’s market entry and we expect this will be a transformative milestone for MorphoSys," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Another major accomplishment is our recently signed global collaboration and licensing agreement with Incyte for the further development and commercialization of tafasitamab. We are delighted to have brought Incyte on board, a very strong and dedicated partner. We are now joining forces to unlock tafasitamab’s full potential and value. With MorphoSys’ commercial entity in the U.S. now up and running, we are confident that we are fully prepared for the anticipated launch. Beyond tafasitamab, we also reported progress for our other proprietary candidates, with MOR202 now being tested in an autoimmune disease, while our partner I-Mab initiated the pivotal development in multiple myeloma, and otilimab is now in phase 3 development in rheumatoid arthritis, led by GSK. We look forward to exploiting the numerous opportunities lying within our pipeline."

"As in previous years, we have met our improved financial guidance for revenues, R&D expenses and EBIT" added Jens Holstein, Chief Financial Officer of MorphoSys. "We increased our revenue and EBIT projections following a €22 million milestone payment by GSK in July of 2019. With the Incyte collaboration becoming effective, we have been able to further strengthen our cash position of €357.4 million by year-end, adding another $900 million to the company’s accounts. In summary, 2019 and the start of 2020 have been financially as well as operationally very successful. MorphoSys is in excellent shape to realize its strategic goals for the years to come."

Financial Review for the Fiscal Year 2019 (IFRS)

In 2019, MorphoSys continued to focus on applying its proprietary technology and expertise to the research and development of innovative drug candidates, both for partners and for its own account. Group revenues for 2019 reached €71.8 million (2018: €76.4 million).

Revenues for 2019 include €62.3 million for success-based payments received primarily from Janssen (2018: €19.4 million) including royalties on net sales of Tremfya(R) amounting to €31.8 million for 2019 (2018: €15.4 million). Due to a contractually triggered currency conversion effect, the Tremfya(R) royalty revenue for 2019 was lowered by €3.0 million.

In the Proprietary Development segment, MorphoSys focuses on research and clinical development of its own drug candidates in the fields of cancer and inflammation. In 2019, this segment recorded revenues of €34.3 million (2018: €53.6 million), which included a €22 million milestone payment by GSK due to the start of the clinical development of otilimab (MOR103/GSK3196165) in rheumatoid arthritis. The decline compared to the previous year was a result of the revenues recognized in 2018 from a €47.5 million upfront payment MorphoSys received under the MOR106 agreement concluded with Novartis in 2018.

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. Revenues in the Partnered Discovery segment increased from €22.8 million in 2018 to €37.5 million in 2019. The segment revenues for 2019 included €4.3 million for funded research and license fees (2018: €3.5 million) as well as €33.2 million for success-based payments received primarily from Janssen (2018: €19.3 million).

Total operating expenses in 2019 increased to €179.9 million from €136.5 million in 2018, based on the ramp-up of preparations for a potential tafasitamab U.S. commercialization as well as build-up of the MorphoSys U.S. operations. In 2019, research and development expenses amounted to €108.4 million, as compared to €106.4 million in 2018. Expenses for proprietary R&D, including technology development, amounted to €98.6 million (2018: €98.3 million).

In 2019, cost of sales increased to €12.1 million (2018: €1.8 million) mainly driven by material produced for the potential launch of tafasitamab. Selling expenses increased to €22.7 million (2018: €6.4 million), and general and administrative expenses increased from €21.9 million in 2018 to €36.7 million in 2019, both primarily as a result of higher personnel expenses and expenses for external services.

Earnings before interest and taxes (EBIT) amounted to €-107.9 million (2018: €-59.1 million) in line with the updated guidance from July 2019 (€-105 to €-115 million). The Proprietary Development segment reported an EBIT of €-109.1 million (2018: €-53.2 million). EBIT in the Partnered Discovery segment was €26.8 million (2018: €13.3 million). In 2019, the consolidated net loss amounted to €-103.0 million (2018: €-56.2 million). The loss per share for 2019 was €-3.26 (2018: €-1.79).

At year-end 2019, the Company had € 357.4 million in cash, reported on the balance sheet under the line items "cash and cash equivalents"; "financial assets at fair value through profit or loss"; and current and non-current "other financial assets at amortized cost". On December 31, 2018, the Group’s liquidity position amounted to €454.7 million.

The number of shares issued totaled 31,957,958 at year-end 2019 (year-end 2018: 31,839,572).

Financial Guidance and Operational Outlook for 2020

For the financial year 2020, MorphoSys will continue to invest strongly in the development of its proprietary candidates, with the primary goal of driving tafasitamab to market and preparing the Company for its commercialization. For 2020, MorphoSys expects to generate Group revenues in the range of €280 to €290 million. This guidance does not include revenues generated from tafasitamab and revenues from future collaborations and/or licensing agreements. Revenues are expected to include royalty income from Tremfya(R) of €37 to €42 million. R&D expenses are anticipated in a corridor of €130 to €140 million. The Company expects earnings before interest and taxes (EBIT) of €-15 to €5 million. The guidance is based on constant currency exchange rates and does not include any contributions from tafasitamab revenues and any effects from potential in-licensing or co-development deals for new development candidates. The operational and financial guidance does not include a potential impact of the ongoing global COVID-19 crisis on MorphoSys’ business operations including but not limited to the Company’s supply chain, clinical trial conduct, as well as timelines for regulatory and commercial execution.

In its Proprietary Development segment, MorphoSys expects the following events and activities in 2020:

Tafasitamab (MOR208)

Market launch of tafasitamab and lenalidomide in r/r DLBCL in the U.S. planned by mid-2020 (under the assumption of an U.S. FDA approval by the PDUFA date of August 30, 2020), together with our partner Incyte as part of the co-commercialization strategy under our collaboration and licensing agreement
Support of Incyte for the submission of a marketing authorization application for tafasitamab and lenalidomide for r/r DLBCL to the European EMA by mid-2020; Incyte has exclusive commercialization rights outside of the U.S.
Continue phase 1b study First-MIND in previously untreated DLBCL
Continue pivotal phase 3 trial evaluating tafasitamab plus bendamustine in r/r DLBCL in comparison to rituximab and bendamustine (B-MIND trial)
Continue phase 2 COSMOS trial of tafasitamab with idelalisib and venetoclax in CLL/SLL.
Expansion of tafasitamab’s clinical development beyond DLBCL under the collaboration and licensing agreement with Incyte
Commercial activities: Continued expansion of the commercial infrastructure and strategic presence in the U.S. to ensure tafasitamab launch readiness, matched by the resources provided by Incyte
MOR202

MorphoSys: Continue clinical development of MOR202 in membranous nephropathy as well as other autoimmune indications.
I-Mab: Continue pivotal development program with MOR202 in multiple myeloma in the Chinese region.
Otilimab (MOR103/GSK3196165): GSK to continue clinical phase 3 development program with otilimab in rheumatoid arthritis.

MOR107: Continue preclinical investigation of MOR107 with a focus on oncology indications.

In its Partnered Discovery segment, MorphoSys expects the following events in 2020:

Tremfya(R) (guselkumab):

Janssen is currently conducting a series of clinical studies with Tremfya(R) (guselkumab) in various indications that could generate data during 2020. In 2019, Janssen submitted marketing authorization applications to the U.S. FDA and EMA for Tremfya(R) for the treatment of psoriatic arthritis. Decisions on these applications could potentially be made in 2020.

Other partnered programs: Publication of clinical data and achievement of regulatory milestones from other partnered programs may occur during 2020.

Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’ partners.

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

MorphoSys Group Key Figures (IFRS, end of financial year: December 31)

* Percentage point
** Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.
*** Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK, and MOR106, whose development in atopic dermatitis has being stopped for futility.

MorphoSys will hold its conference call and webcast tomorrow, March 19, 2020, to present the annual financial results 2019 and the outlook for 2020.

Dial-in number for the analyst conference call (in English) at 2:00pm CET; 1:00pm GMT; 9:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 48530958#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at View Source

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

Consolidated Financial Statements 2019 (IFRS) are available for download at:
View Source

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing.In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. In the U.S., MorphoSys and Incyte will co-commercialize tafasitamab, outside the U.S., Incyte will have exclusive commercialization rights. Tafasitamab is being clinically investigated as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The ongoing phase 3 study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On March 18, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it has completed a $43.7 million private placement of common stock and warrants (Press release, Protalix, MAR 18, 2020, View Source [SID1234555676]). In connection with the offering, the Company issued 17,604,423 unregistered shares of the Company’s common stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of common stock at an exercise price of $2.36 per share. Net proceeds to the Company from the private placement are expected to be approximately $41 million, after deducting advisory fees and other estimated offering expenses. Rosario Capital and Houlihan Lokey Capital Inc. served as financial advisors in the private placement.

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The Company intends to use the net proceeds from the financing to advance the Company’s clinical programs of PRX-102, the Company’s product candidate under development for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics, and for general corporate purposes.

"We appreciate the confidence expressed by our new and existing stockholders in Protalix’s commitment to bring important treatment options to the Fabry patient community," said Dror Bashan, Protalix’s President and Chief Executive Officer. "This funding gives us the runway and ability to complete our pivotal Phase III BALANCE clinical trial of PRX-102, as well as pursue strategic opportunities to bring additional value to the Company and its stockholders."

Neither the shares of the Company’s common stock nor the warrants sold in the private placement have been registered under the U.S. Securities Act of 1933 (the "Securities Act") or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement, including the shares of common stock issuable upon exercise of the warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On March 18, 2020 THERADIAG (ISIN: FR0004197747, Mnémonique: ALTER), a company specializing in in vitro diagnostics and theranostics reported its annual results for the year ended December 31, 2019 and adopted by the Board of Directors on March 17, 2020 (Press release, Theradiag, MAR 18, 2020, View Source [SID1234555673]).

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2019 annual results

Notes: (1) Social accounts for 2018 of the company Theradiag restated for consolidation items, the Prestizia subsidiary not being consolidated since 2019. (2) Following a final post-publication audit of turnover of Jan. 30, 2020, turnover has been adjusted to € 9,638 thousand instead of € 9,647 thousand previously

Bertrand de Castelnau, CEO of Theradiag , comments "Theradiag’s 2019 annual results are fully in line with our expectations. Excluding exceptional items, the result for the year is even closer to breakeven, it is a first great achievement on the path to profitability. Innovation remains absolutely central to Theradiag’s growth and we are very satisfied with our continuous investment in R&D, in theranostics in particular with our new i-Track 10 automated system. We have before us important stages of development to come in 2020, particularly internationally in the United States, where we wish to accelerate our presence. We are pleased to announce today a tangible improvement in our financial indicators and look forward to the next few years. "

"The priorities for 2019 were clear and the team’s commitment to achieving them was productive. The exceptional result generated allows Theradiag to pursue its development strategy in a calm manner. The company has real growth potential to assert itself even more in 2020, in France and on its priority markets, as the leader in monitoring biotherapies, " added Pierre Morgon, Chairman of the Board of Directors.

[…]

Financial calendar:

Annual General Meeting, May 14, 2020
Sales for the first half of 2020 , Tuesday July 21, 2020
Upcoming conferences in which Theradiag participates, subject to confirmation:

May 2-5, 2020: Digestive Disease Week (DDW) Congress, Chicago, USA
May 20-24, 2020: 11th International Autoimmunity Congress, Athens, Greece
June 25 to 26, 2020: Nils-Olivier Olsson conference at GEAI, Paris
June 25 to 26, 2020: Francophone Days of Hepato-gastroenterology and Digestive Oncology 2020 (JFHOD), Paris.

On March 18, 2020 Sunesis Presented the Corporate Presentation (Presentation, Sunesis, MAR 18, 2020, View Source [SID1234555669]).

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On March 18, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported preliminary antigen-specific immune response data from a Phase 2 randomized investigator-sponsored trial (IST) of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal (Press release, Sellas Life Sciences, MAR 18, 2020, View Source [SID1234555668]).

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"We are pleased to report preliminary results from the National Cancer Institute-sponsored Phase 2 VADIS trial, showing NPS is capable of inducing an antigen-specific antitumor immune response in DCIS patients even after a single vaccination, which is particularly encouraging," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Based on the immunobiological mechanism of action of NPS, we believe that NPS could be synergistic with standard therapies or novel immunotherapeutic approaches in women with DCIS. Moreover, these data correlate to previous findings of NPS in patients with invasive (non-DCIS) breast cancer. Given NPS’ low toxicity burden and high antigen-specific immune response, further clinical study of NPS as a therapeutic which could address the medical need of women with DCIS at an early stage of their therapeutic journey is likely warranted and these data further support our business development efforts to seek out-licensing opportunities to fund and conduct the future clinical development of NPS in order to maximize the potential of the program."

The study enrolled 13 patients, with nine patients receiving NPS plus GM-CSF and four patients receiving GM-CSF only. The relative frequency of NPS-specific CD8 cytotoxic T-lymphocytes as a percentage (NPS-CLT%) was twice as large in the NPS-treated patients. The NPS-CLT% was measured in the peripheral blood by a sensitive and specific assay using dextramer staining followed by flow cytometry, both at baseline (before vaccination or GM-CSF) and at 30 (+/-7) days after surgery. The mean difference in NPS-CTL% increase between the active and control groups was +0.10% vs +0.05%. The relative magnitude of change in NPS-CTL% mean values in NPS-treated patients over time was an 11-fold increase, from 0.01% at baseline to 0.11% after surgery, indicating a continued antigen-specific T-cell response post-NPS vaccination. NPS was generally well-tolerated in the study with no drug-related unexpected serious adverse reactions. The overall adverse event profile was consistent with previous safety data.

The final data is being further analyzed by the National Institute of Health, MD Anderson Cancer Center and the study principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Women’s Cancer Center, and will be presented at an upcoming medical conference.

"The preliminary data from the VADIS study showing a doubling of the difference in increase in antigen-specific CD8 cytotoxic T-lymphocytes in NPS-treated patients vs. controls, even with a single NPS inoculation, indicate in vivo immunogenicity of this cancer vaccine in DCIS. These data, as well as the previously reported clinical effects of NPS in the adjuvant setting after frontline therapy for invasive breast cancer, provide support for the possibility that NPS may be able to decrease the rate of recurrences in earlier-stage disease, such as DCIS, which I believe should be studied formally in future clinical studies," said Dr. Mittendorf. "While additional analyses of certain histologic and molecular markers of the patients’ immune responses against the NPS and other HER2 antigenic epitopes are currently ongoing, these initial immunobiological results from the VADIS study are encouraging."

About the Phase 2 VADIS Trial

This Phase 2 randomized trial is sponsored and operationalized by the National Cancer Institute (NCI) to study NPS’ potential clinical effects in earlier-stage disease. Patients are randomized to receive, prior to surgery, either GM-CSF followed by NPS two weeks later or GM-CSF alone. The primary endpoint of the trial is the difference in the frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two arms of the study, using a dextramer assay. Secondary endpoints to be compared between the two arms include the nature and incidence of adverse events and in vivo immune response to NPS, in addition to other select histologic and molecular biomarkers.

About DCIS

DCIS is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct and have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast neoplasm with malignant potential. In some cases, DCIS may become invasive cancer and spread to other tissues and, currently, it is not possible to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. Tamoxifen is given in cases with hormone receptor positivity only. No targeted or immune therapies have shown any definitive clinical activity in DCIS to date. The current standard treatment aims at forestalling the progression of DCIS to invasive cancer. In approximately 15-25% of cases progression does occur. DCIS is diagnosed in more than 60,000 women each year in the United States, comprising 1 in 5 newly diagnosed cases of breast cancer.