On December 17, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Pint Pharma, a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market, reported the receipt of approval from the Brazilian Health authority to initiate the INSPIRE Trial in Brazil with intravenous rigosertib in Higher-Risk MDS (HR-MDS) (Press release, Onconova, DEC 17, 2019, View Source [SID1234552438]). In November 2019 enrollment in the INSPIRE Trial surpassed 90% percent of the required enrollment, and the Company continues to anticipate reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events.

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"As we enter the final stage of enrollment of the INSPIRE Trial, we thank our corporate partner Pint Pharma for their collaboration in opening the study in Brazil," said Dr. Steven Fruchtman, President and CEO of Onconova Therapeutics, Inc. "The INSPIRE Trial surpassed 90% percent of the required enrollment in November 2019 and we expect the addition of up to 16 clinical trial sites in Brazil will provide further momentum to our anticipated reporting of topline data in the first half of 2020, following full enrollment and reaching the number of required survival events."

"We are excited to collaborate with Onconova in opening new clinical sites and look forward to the recruitment of eligible patients for the INSPIRE Trial in Brazil," said David Munoz, Chief Executive Officer of Pint Pharma. He added, "We are also pleased that local physicians will gain invaluable experience with rigosertib by their participation on the INSPIRE Trial."

Dr. Ric Woodman, Chief Medical Officer of Onconova, is working closely with Dr. Valnei Canutti, Chief Scientific Officer of Pint. Dr. Woodman commented, "There is a great unmet medical need and interest to conduct studies in patients with HR-MDS in this geographical region. I look forward to a productive collaboration with Pint Pharma and working with Dr. Canutti, an expert in conducting trials in Brazil as well as an expert in MDS."

Dr. Canutti added, "We anticipate meaningful contributions from Brazil to accrual to the INSPIRE Trial and are excited about receiving health authority approval to initiate INSPIRE in Brazil. There are significant numbers of patients with HR-MDS in Brazil with no approved approach following failure of the standard of care azacitidine. We at Pint, in collaboration with our partner Onconova, look forward to Brazil’s contributions to complete accrual to this important pivotal global trial."

About Pint Pharma

Pint Pharma is devoted to the development, registration, and commercialization of specialty-based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care, and Oncology.

On December 17, 2019 Eli Lilly and Company (NYSE: LLY) reported its 2020 financial guidance, highlighted by volume-based revenue growth and improving productivity, which are expected to result in operating margin expansion and strong earnings performance (Press release, Eli Lilly, DEC 17, 2019, View Source [SID1234552420]). The company also revised certain elements of its 2019 financial guidance and reviewed potential key events for the upcoming year, including important data readouts for several investigational medicines in its clinical pipeline, the possibility for two regulatory approvals, and up to three new launches in 2020.

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Josh Smiley, Lilly’s chief financial officer, outlined the company’s near-term growth prospects and provided 2020 financial guidance. "We expect 2020 to be a year of strong operating and financial performance for Lilly, characterized by revenue growth for our key medicines both in the U.S. and in international markets, ongoing productivity initiatives leading to further margin expansion, continued progress in our clinical pipeline of new medicines, and solid cash flow." said Smiley. "We are confident in our ability to deliver on our 2020 expectations, and thereby achieve or exceed the financial and pipeline commitments we had previously made for the period 2015-2020."

Commenting on the company’s cash flow expectations, Smiley added, "Our robust financial performance is expected to generate strong cash flow, which we will continue to deploy thoughtfully. Our capital allocation priorities remain unchanged, starting with funding our promising pipeline and our recently launched medicines, then leveraging business development to access additional external innovation opportunities, followed by returning cash to shareholders through our recently-increased dividend and our ongoing share repurchase program."

"Lilly is in the early phase of an exciting period of prolonged growth for the company, driven by an expanding portfolio of new medicines focused on diabetes, oncology, immunology, and neuroscience," said David A. Ricks, Lilly’s chairman and chief executive officer. "With an attractive commercial portfolio and limited patent exposure through the latter half of the upcoming decade, we are well positioned to deliver sustainable volume-based revenue growth and drive further operating margin expansion. As we continue to invest in our innovation-based strategy, we are confident in our ability to discover and develop important new medicines for patients."

2019 Financial Guidance

The company has updated certain elements of its 2019 financial guidance. On a reported basis, earnings per share for 2019 are now expected to be in the range of $8.57 to $8.67. The decrease in expected earnings per share on a reported basis is due to a net charge related to the repurchase of debt, and additional asset impairment, restructuring, and other special charges related to global cost reduction initiatives, largely offset by a gain on the sale of the company’s antibiotics business in China. On a non-GAAP basis, earnings per share for 2019 are still expected to be in the range of $5.75 to $5.85.

Non-GAAP guidance reflects adjustments presented in the earnings per share table above.

2020 Financial Guidance
The company today issued its 2020 financial guidance. Earnings per share for 2020 are expected to be in the range of $6.38 to $6.48 on a reported basis and $6.70 to $6.80 on a non-GAAP basis. Non-GAAP earnings per share for 2020 exclude amortization of intangible assets.

Numbers may not add due to rounding

The company anticipates 2020 revenue between $23.6 billion and $24.1 billion. Meeting its 2020 revenue forecast would allow the company to achieve or exceed the 7 percent revenue CAGR target it previously communicated for the time period 2015 – 2020. Revenue growth is expected to be driven by volume from key growth products including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant, Emgality, BaqsimiTM, and the expected launch of ReyvowTM. Revenue growth could also benefit from the potential launch of other new medicines. Revenue growth is expected to be partially offset by lower revenue for products that have lost patent exclusivity, including the expected entry of generic competition for Forteo in the U.S. Revenue growth is also expected to be partially offset by a low-single digit net price decline in the U.S. driven primarily by rebates and legislated increases to Medicare Part D cost sharing, patient affordability programs, and net price declines in China, Japan and Europe.

Gross margin as a percent of revenue rate is expected to be approximately 79 percent on a reported basis, and approximately 81 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are expected to be in the range of $6.1 billion to $6.3 billion. Research and development expenses are expected to be in the range of $5.6 billion to $5.9 billion.

Operating margin, defined as operating income as a percent of revenue, is expected to be 31 percent on a non-GAAP basis in 2020.

Other income (expense) is expected to be expense in the range of $100 million and $250 million.

The 2020 effective tax rate is expected to be approximately 15 percent on both a reported basis and on a non-GAAP basis.

The following table summarizes the company’s 2020 financial guidance.

Non-GAAP guidance reflects adjustments presented in the earnings per share table above.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the 2020 financial guidance conference call through a link on Lilly’s website at www.lilly.com. The conference call will begin at 9:00 a.m. Eastern time (ET) today and will be available for replay via the website.

On December 17, 2019 PharmaMar (MSE:PHM) has reported that it has submitted to the FDA (Food and Drug Administration) in the United States the New Drug Application (NDA) for lurbinectedin for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy, under the accelerated approval regulations (Press release, PharmaMar, DEC 17, 2019, View Source [SID1234552440]).

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This NDA is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of SCLC, the results of which were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June this year. A total of 105 patients from 39 centers in more than 8 Western European countries in addition to the United States were recruited. The trial met its primary endpoint of the Overall Response Rate (ORR) by both investigator and IRC (Independent Review Committee) assessment.

The FDA’s accelerated approval procedure allows for the submission of an NDA for evaluation based on the results of phase II drug investigations for the treatment of serious diseases that cover an unmet medical need. Relapsed SCLC treatment has not changed substantially in more than two decades with the last new chemical entity approved by the FDA in this setting being topotecan, in 1996.

"The application for registration under accelerated approval regulations gives us the possibility that the FDA could approve lurbinectedin in the US for treatment of small cell lung cancer in 2020 and that, if approval is obtained, could begin to be marketed 2 in the second half of 2020 in the United States", explains Luis Mora, General Manager of PharmaMar’s Oncology Business Unit.

Dr. Charles Rudin, Chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of the NCI Small Cell Lung Cancer Consortium, said "It is great to finally see some new therapeutic options arriving for small cell lung cancer patients, who represent a major unmet medical need. I have been following the emerging clinical trial data on lurbinectedin, which suggest appealing efficacy and a tolerable safety profile. I believe many treating physicians may welcome lurbinectedin, if approved, as a new standard of care option for their patients with recurrent small cell lung cancer." We would like to extend our sincerest gratitude to the patients, their families and caregivers, as well as the dedicated medical teams who participated in our clinical trials studies and helped bring lurbinectedin to this point.

On December 17, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that it will host a key opinion leader (KOL) call on Epigenetics, Thursday, December 19th at 12pm Eastern Time (Press release, Flex Pharma, DEC 17, 2019, View Source [SID1234552422]).

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The call will feature a presentation by KOLs Damon Reed, MD, Moffitt Cancer Center, and Johnathan Whetstine, PhD, Fox Chase Cancer Center, who will discuss Epigenetics, and how drugs that regulate gene expression ("epigenetic drugs") are a viable strategy for treatment and management of cancer. They will also discuss recent clinical successes with epigenetic drugs, and what to expect from novel agents. Drs. Reed and Whetstine will be available to answer questions at the conclusion of the call.

The call will also feature a presentation by Salarius’ management team, which will provide an update on their lead program, Seclidemstat. Management will share the latest on their clinical program and on new areas of interest including immunotherapy and select tumor mutations. Seclidemstat, a reversible LSD1 inhibitor, inhibits LSD1’s enzymatic and scaffolding properties, representing a viable therapeutic option for patients who need it the most.

Damon Reed, MD is the Director of the Adolescent and Young Adult Program at Moffitt Cancer Center, an Associate Member of the Sarcoma Department at Moffitt Cancer Center and an Assistant Professor of Pediatrics at the University of South Florida. He is also on staff as a specialty physician at All Children’s Hospital in St. Petersburg, FL. He is the Leader of the National Pediatric Cancer Foundation’s pediatric phase I consortium, the Sunshine Project. Dr. Reed’s research interests include chemotherapeutic approaches to sarcoma in the pediatric and adolescent and young adult population. He is interested in establishing relevant preclinical sarcoma models, establishing and testing biomarkers for targeted therapies and translating predictive testing and combinations of agents towards personalized medicine in sarcoma and other rare cancers. A graduate of Case Western Reserve University School of Medicine in Cleveland, OH, Dr. Reed served a combined pediatric residency program at Boston Children’s Hospital-Harvard Medical School and Boston Medical Center-Boston University School of Medicine. He completed his fellowship training in pediatric hematology/oncology at St. Jude Children’s Research Hospital. Dr. Reed has received numerous academic awards, including graduating valedictorian from Canfield High School and summa cum laude from the University of Dayton. He received the CWRU Medical Alumni Association Board of Trustees Award for Outstanding Service and Contributions to the School of Medicine and was named to the Alpha Omega Alpha Honor Medical Society. Dr. Reed is a member of several professional associations, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Connective Tissue Oncology Society and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Dr. Reed is the Principal Investigator of Salarius’s ongoing Ewing sarcoma Phase 1/2 clinical trial.

Johnathan Whetstine, PhD is the Program Leader of the Cancer Epigenetic Program at the Fox Chase Cancer Center. A rising star in the field of epigenetics, Dr. Whetstine has made groundbreaking discoveries that have expanded the field and provided significant implications for understanding tumor heterogeneity and drug response. In recognition of the promise of his research, he holds the prestigious Scholar award from the Leukemia & Lymphoma Society and a National Institutes of Health R01 grant, as well as funding from the American Lung Association, Alex Lemonade Stand Foundation and AstraZeneca. Recently, Dr. Whetstine helped coordinate the Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic, which brought together experts in the field of LSD1 research. Prior to Fox Chase, Dr. Whetstine was at Massachusetts General Hospital Cancer Center and Harvard Medical School in Boston, where he served as vice chair of the Epigenetics Program. He also held appointments as associate geneticist and associate professor in the department of medicine, respectively. He completed his postdoctoral fellowship in epigenetics/pathology in the laboratory of Yang Shi, PhD, at Harvard Medical School, and earned his PhD in pharmacology from Wayne State University in Detroit. Dr. Whetstine has served on Salarius’s Advisory Board.

On December 17, 2019 Cellestia Biotech AG reported the closing of a CHF 20 million Series B financing round (Press release, Cellestia Biotech, DEC 17, 2019, View Source [SID1234552441]). The new funds will be added to the previous, including CHF 8 million Seed financing, CHF 20 million Series A financing and CHF 1 million non-dilutive research grants, bringing the total capital raised to date by Cellestia to CHF 49 million (USD 50 million).

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"This financing strengthens our balance sheet as we work to achieve important milestones for our clinical candidate CB-103 as well as the follow-up compounds," said Gaudenz von Capeller, CFO of Cellestia Biotech AG.

Cellestia is progressing the ongoing clinical development program of CB-103, a first-in-class small molecule targeted therapy with a novel mode of action. CB-103 is a highly selective protein-protein interaction inhibitor targeting an oncogene transcription factor for the precision medicine treatment of specific cancers. It will also allow Cellestia to advance its innovative R&D pipeline activity.

In June 2019, Guido Guidi (Former Head Europe Novartis Pharma / Head Novartis Oncology Europe) was elected new Chairman of Board of Directors. Robert Karsunky (Head Latin America & Canada at Novartis Pharma) elected new Chairman of the Audit Committee and to the Board of Directors.

Michael Bauer, CEO of Cellestia Biotech AG said, "Guido’s experience and knowledge in development, business and building a successful organisation is a tremendous asset to our company, and we are delighted that he has joined Cellestia as Chairman of our Board. Robert brings long-standing financial expertise to the board and strengthens internal governance in his roles of Chairman of the Audit Committee and Member of the Board. With these additions to the board, we are further adopting the board memberships in line with the company´s growth and development."

"I am excited to be a part of Cellestia’s journey. I find the science to be compelling and look forward to supporting the development of this novel precision oncology solution," said Guido Guidi.

About PPF/SOTIO

PPF Group is an international investment company focusing on multiple market segments such as banking, financial services, telecommunications, insurance, real estate, agriculture and biotechnology. PPF’s reach spans from Europe to Russia, the USA and across Asia. PPF’s assets under management totalled to almost EUR 47 billion (as at 30 June 2019). SOTIO is an international biotechnology company spearheading PPF’s investment and partnering activities in the biotechnology sector. For more information about PPF and Sotio visit www.ppf.eu and www.sotio.com.

About FC Capital

FC Capital is a China-based private equity firm specializing in healthcare investments in the Greater China region, the US and the European countries. FC Capital focuses in cultivating and investing in early and growth stage sector leaders ranging from pharmaceutical companies to technology and data providers that are aligning with secular growth trends or building innovative solutions to emerging challenges. Its parallel RMB and USD funds target high-quality companies looking for a patient and strategic partner to achieve unprecedented cross-border and long-term success.