On March 18, 2020 Allergan plc (NYSE: AGN) reported that its Board of Directors has declared a cash dividend of $0.74 per ordinary share for the second quarter of 2020 (Press release, Allergan, MAR 18, 2020, View Source [SID1234555680]). The dividend will be paid on the closing date of AbbVie’s pending acquisition of Allergan, which remains subject to regulatory approval and customary closing conditions, or on June 15, 2020 if closing has not yet occurred. Allergan’s second quarter 2020 dividend will be paid to shareholders of record at the close of business on April 16, 2020.

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On March 18, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the year ended December 31, 2019 (Press release, ProMIS Neurosciences, MAR 18, 2020, View Source [SID1234555679]). All financial numbers referenced herein are reported in Canadian Dollars.

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"Over the course of the past year, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases", stated Eugene Williams, ProMIS’ Executive Chairman.

"PMN310, our lead antibody therapeutic candidate for Alzheimer’s disease, showed further significant positive differentiation in both potential efficacy and safety compared to competitive antibody therapeutics currently in development. In addition, antibody candidates selectively targeting toxic forms of alpha-synuclein for Parkinson’s disease, toxic aggregated forms of TDP-43 for amyotrophic lateral sclerosis (ALS) and toxic aggregates of tau for AD and other dementias were identified and further characterized to support pharmaceutical partnering discussions."

Corporate Highlights

During 2019, we completed private placements providing aggregate gross proceeds of $6,169,133.
During 2019, we received proceeds from the exercise of warrants in the amount of $92,500.
In January and February 2020, we received proceeds from the exercise of warrants in the amount of $958,000.
Alzheimer’s disease (AD) program
In May 2019, we announced the identification of novel antibodies for AD with selectivity for the neurotoxic form of tau. ProMIS leveraged its proprietary drug discovery and development platform to identify several novel antibodies that selectively bind toxic oligomers of tau.
ProMIS presented key data on monoclonal antibody PMN310 for AD at the Keystone Symposium on Neurodegenerative Diseases: New Insights and Therapeutic Opportunities, in June 2019 in Keystone, Colorado.
ProMIS’ Chief Development Officer, Dr. Johanne Kaplan, delivered an oral presentation "Selective Targeting of Amyloid-Beta Oligomer Species by PMN310, a Monoclonal Antibody Rationally Designed for Greater Therapeutic Potency in Alzheimer’s Disease," on July 18, 2019, at the Alzheimer’s Association International Conference (AAIC).
On October 17, 2019, following on from its initial announcement of the ProMIS tau program, preclinical data showed that these candidate antibodies can block the formation of pathogenic tau aggregates in a cellular model. The Company leveraged its proprietary drug discovery and development platform to identify conformational epitopes on misfolded tau and generate, evaluate and advance tau antibody candidates, demonstrating the platform’s capacity for producing high-quality antibody candidates rapidly and cost-effectively.
In November 2019, the Company posted a narrated overview of its next-generation amyloid-beta (Aβ)-targeting drug candidate, PMN310 for AD, juxtaposed with Biogen’s first-generation candidate, aducanumab. The narrative details PMN310’s superior binding to the toxic form of Aβ, amyloid beta oligomers (AßOs), potentially without the dose-limiting side effect, ARIA-E (brain swelling), associated with aducanumab. Upon eventual regulatory approval of aducanumab, PMN310 is positioned to be a next-generation, amyloid-beta-targeting candidate for AD.
Parkinson’s disease (PD) program
Preclinical in vitro studies show that ProMIS’ antibody candidates for PD block both the neurotoxicity and the spread of toxic alpha-synuclein, which favourably compares with traditional methods unable to generate antibodies with adequate precision in targeting neurotoxic forms. These findings and further results of the Corporation’s PD program were reported at the International AD/PD 2019 Conference on March 31, 2019.
ProMIS also announced in October 2019 it had identified several novel antibody candidates for Multiple System Atrophy (MSA), a severe, Parkinson’s-like disease caused by toxic, misfolded forms of alpha-synuclein.
ALS program
In October 2019, ProMIS announced advancement of its ALS program selectively targeting the toxic form of TDP-43. New data generated by ProMIS’ unique drug discovery and development platform demonstrated that several antibody candidates show selectivity for toxic, misfolded intracellular aggregates of TDP-43 with no binding to normal TDP-43 located in the cell nucleus. ProMIS antibody candidates also show selective binding to the pathogenic, misfolded form of TDP-43 in post-mortem brain tissue from patients with frontotemporal dementia (FTD).
People
Mr. Timothy G. Rothwell was appointed to the Company’s Business Advisory Board, effective February 2019.
C. Warren Olanow, MD, was appointed to the Company’s Scientific Advisory Board ("SAB") in June 2019 and Andre Strydom, MD, was also appointed to the SAB in August 2019.
José Luis Molinuevo, MD, PhD, was appointed to the Corporation’s SAB in January 2020.
Financial Results

Annual Results of Operations

The Company’s net loss for the year ended December 31, 2019 was $7,396,259, compared to a net loss of $10,167,050 for the year ended December 31, 2018. Included in the net loss for the year ended December 31, 2019 were non-cash expenses of $655,954, representing share-based compensation and amortization of an intangible asset, compared to $1,081,600 for the year ended December 31, 2018. The decrease in the net loss for the year ended December 31, 2019 reflects decreased costs associated with external contract research organizations for internal programs, patent costs and share-based compensation offset by increased consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the year ended December 31, 2019 were $4,735,317, as compared to $7,409,546 in the year ended December 31, 2018. The decrease in research and development expense for the year ended December 31, 2019 is primarily attributed to decreased spending on external contract research organizations for internal programs, reduced patent expense and share-based compensation offset by increased contracted research salaries and associated costs and external consulting expense.

General and administrative expenses for the year ended December 31, 2019 were $2,662,144, as compared to $2,757,979 in the year ended December 31, 2018. The decreased expenditures for 2019 is primarily attributable to decreased share-based compensation and other professional fees offset by increased investor relations/public relations, salaries and foreign exchange loss on U.S. Dollar denominated expenses.

Outlook

As a prelude to the first PMN310 clinical trial in AD, ProMIS anticipates using a novel biomarker approach that may show evidence of slowing of neuronal death early in the development program. To accomplish this, we initiated the pilot phase of a natural history evaluation of biomarker changes in untreated, mild AD patients in February 2020.We anticipate potential initial results of the first clinical trial with PMN310 in late 2021.

The Company will also continue to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 in ALS, toxic forms of alpha-synuclein in PD and toxic aggregates of tau in AD and other dementias to further support on-going pharmaceutical partnering discussions. ProMIS’ unique platform produces antibodies that meet a key success factor for development of therapeutics for neurodegenerative diseases: the ability to selectively target the neurotoxic form of a protein implicated as a root cause of disease, while sparing the normal forms of the protein.

ProMIS’ portfolio of antibody candidates that selectively target toxic species of proteins, while sparing the normal protein forms that have important physiologic functions, are of particular interest for safe and effective intracellular delivery via vectorization, an exciting recent development.

On March 18, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, reported fourth quarter and full year 2019 financial results (Press release, Cumberland Pharmaceuticals, MAR 18, 2020, View Source [SID1234555678]). Net Revenues for the fourth quarter were $13.7 million, and for the full year 2019, Net Revenues totaled $47.5 million, a 17% increase over the prior year.

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As of December 31, 2019, the total assets of the Company grew to $104.5 million, including $28.2 million in cash and investments. Total Liabilities were $53.5 million, and Total Shareholder’s Equity was $51.1 million. Cumberland also has available $44.1 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.
Fourth Quarter and Annual Highlights:

Received FDA approval for RediTrex line of injectable methotrexate products

Completed initial launch of Caldolor Next Generation product

Completed strategic review of brands, capabilities, and international partners

Initiated clinical program to study ifetroban in patients with Duchenne Muscular Dystrophy

Completed clinical study of Caldolor in children from birth to six months of age

"During 2019, we made significant progress in advancing our major initiatives and accomplishing many key objectives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are working hard to build a specialty pharma business that delivers sustained growth and profitable operations." He continued, "And I’d like to thank our team for all their fine efforts and valuable contributions."

At the beginning of 2019, Cumberland commenced a strategic review of its brands, capabilities, and international partners. This review followed an accelerated business development initiative, which resulted in a series of transactions. Because of that progress, the Company felt that it was prudent to take a fresh look at its product portfolio, partners, and organization to ensure proper focus and capabilities.
As a result of the strategic review:
Cumberland executed a License and Distribution agreement with HongKong WinHealth Pharma Group Co. Limited ("WinHealth") for Caldolor and Acetadote in China and Hong Kong. Cumberland also entered into a Strategic Alliance agreement with WinHealth to explore future business opportunities that will further the mission and goals of each organization.
The Company also completed an agreement with Hikma Pharmaceuticals LLC to register and distribute Vibativ in the Middle East, finalized arrangements with R-Pharma JSC for ongoing distribution of Vibativ in Russia and Eastern Europe, and completed an agreement with Dr. Reddy’s Laboratories Limited for the registration and distribution of Vibativ in India.
Cumberland concluded its agreement with Clinigen Group plc ("Clinigen") for the distribution and support for Ethyol and Totect. As a result, Cumberland will no longer be involved with the distribution, marketing, and promotion of Ethyol and Totect in the United Stated. At the end of 2019, the Company transitioned the responsibilities of both products back to Clinigen. Cumberland will receive $5 million in financial consideration paid over the two-years following the transition date of December 31, 2019.
Cumberland’s newest marketed brand, Vibativ (telavancin), was the subject of two favorable clinical publications during 2019. One study showed numerically superior cure rates of telavancin compared to vancomycin within a subset of patients who had hospital-acquired pneumonia. Another study detailed the positive clinical outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin and skin structure infections, bone and joint infections, bacteremia and endocarditis, and lower respiratory tract infections.
Meanwhile, Cumberland continued to advance its clinical programs in 2019. Near the end of 2019, Cumberland was awarded $1 million in grant funding from the FDA to support a Phase II clinical program to study ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"). DMD is a rare, fatal, genetic neuromuscular disease and is characterized by the progressive loss of muscle which results in deterioration of the skeletal, heart and lung muscles.
Early in 2019, Cumberland received FDA approval for its next generation of Caldolor, featuring an improved formulation in a ready-to-use presentation. The Company then commenced an initial launch focused on a select group of key hospitals across the United States. During the third and fourth quarters of 2019, there was a growing demand for the new product from the select accounts and Cumberland began planning for a full-scale national launch in early 2020.
Cumberland also completed its study of Caldolor in patients ranging from newborn to six months of age. Topline results from this study show no safety concerns and similar blood levels to that of older children. Cumberland is now finalizing the study report for submission to the FDA and will pursue label expansion based on this information.
Near the end of 2019, Cumberland received FDA approval for RediTrex, its new line of injectable products designed for treating patients with arthritis and psoriasis. The Company now is actively preparing for the national launch of RediTrex in 2020.

FINANCIAL RESULTS:
Net Revenue: For the three months ended December 31, 2019, net revenues were $13.7 million, up 1% from $13.5 million for the prior year period. Net revenue by product for the three months ended December 31, 2019, included $4.4 million for Ethyol, $3.2 million for Kristalose, $2.5 million for Vibativ, $1.7 million for Caldolor, and $1.2 million for Acetadote, which included the Company’s Brand and Authorized Generic products.
For the year ended December 31, 2019, net revenues were $47.5 million, a 17% increase compared to $40.7 million for the year ended December 31, 2018.
Operating Expenses: Total operating expenses for the three months ended December 31, 2019 were $14.7 million, down from $15.8 million for the prior year period. Total operating expenses for the year ended December 31, 2019 were $51.2 million, compared to $48.1 million for 2018 . The full-year expense increases include additional costs of products sold and an increase in amortization, a non-cash expense.
Adjusted Earnings: Adjusted Earnings for the three months ended December 31, 2019 were $1.5 million, or $0.09 per share, compared to $1.6 million, or $0.10 per share in for the prior year period. Adjusted Earnings for the full year ended December 31, 2019 were $5.0 million, or $0.32 per share, a significant increase over the loss of $(0.5) million, or $(0.03) per share in 2018.
This performance measure represents net income attributable to common shareholders with adjustments for the impact of income taxes, depreciation, amortization, share based compensation expenses, Vibativ costs of products sold, and expenses that are non-core to the operating performance of the period. The definition and the reconciliation of Adjusted Earnings are provided in this release.
Balance Sheet: At December 31, 2019, Cumberland had $28.2 million in cash and marketable securities. Total assets at December 31, 2019 were $104.5 million. Total Liabilities were $53.5 million, including $18.5 million outstanding on the Company’s revolving line of credit and $8.6 million related to contingent liabilities related to the Vibativ acquisition, resulting in Total Shareholder’s Equity of $51.1 million.

Conference Call and Webcast
A conference call and live Internet webcast will be held on Wednesday, March 18, 2020 at 4:30 p.m. Eastern Time to discuss the Company’s fourth quarter and annual 2019 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9759981. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

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.