On December 17, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the first patient has been successfully dosed in the Phase I study with the wholly owned 4-1BB antibody ATOR-1017, which is being developed for the treatment of metastasized cancer (Press release, Alligator Bioscience, DEC 17, 2019, View Source [SID1234552427]).

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The Phase I study is a dose escalation study in patients with advanced cancer and this is the first time ATOR-1017 is being evaluated in humans. The study will be conducted at three different clinics in Sweden and include up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

ATOR-1017 activates 4-1BB receptors which increases the ability of the immune system to detect and kill tumor cells. This makes 4-1BB a particularly attractive target for cancer immunotherapy. ATOR-1017 has a unique profile related to the fact that its immune-stimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation that can increase efficacy and reduce side effects for the patient.

"In the preclinical studies, ATOR-1017 has showed a strong and long-lasting immune response, and even created immunity to cancer, while minimizing the side effects through tumor-directed immune activation. This profile puts ATOR-1017 at the forefront of the field and it will be very exciting to follow the continued clinical development ", said Per Norlén, CEO of Alligator Bioscience.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact persons set out above, at 1:00 p.m. CET on December 17, 2019.

On December 17, 2019 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has priced the underwritten public offering of 28,125,000 shares of its common stock at $1.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $45,000,000 (Press release, MEI Pharma, DEC 17, 2019, View Source [SID1234552425]). In connection with the offering, the Company granted the underwriters a 30-day option to purchase up to an additional 4,218,750 shares of common stock. The offering is expected to close on December 19, 2019, subject to customary closing conditions.

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [email protected]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

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 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 16, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported the commercial launch of its Cchek Prostate Cancer Confirmation test (Cchek PCC), the first test developed with the Cchek artificial intelligence driven, flow cytometry based, liquid biopsy technology platform (Press release, Anixa Biosciences, DEC 16, 2019, View Source [SID1234553929]).

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The Cchek PCC test will be offered as a CLIA validated test through Anixa’s partner laboratory, ResearchDx. This test has been independently validated by ResearchDx and is designed to confirm the need for prostate biopsy, as a means to minimize unnecessary invasive procedures and reduce healthcare costs associated with traditional methods of prostate cancer diagnosis and the associated adverse events.

Amit Kumar, Ph.D., Chief Executive Officer of Anixa, stated, "This is a major milestone for Anixa and our partner-based business model. From the start, our goal with Cchek has been to develop an inexpensive blood test that accurately detects the existence of cancer by measuring the body’s immune response."

Data shows that more than 90% of prostate biopsies performed in the U.S. are negative, which indicates that over a million men undergo unnecessary, painful and anxiety-provoking procedures every year. The goal of Cchek PCC is to reduce the number of unnecessary biopsies by between 40% and 50%, while still accurately identifying those patients that require a biopsy to diagnose their prostate cancer.

Dr. Kumar continued, "In the coming months, we expect to conduct a number of activities to support the marketing of Cchek PCC, including the development of marketing materials, education of key opinion leaders in urology, and development of a reimbursement path for the test. We expect Cchek PCC to be broadly available throughout the U.S. by April 2020."

About Cchek
Cchek is an early cancer detection technology, which measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method with greater affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed.