On February 10, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company that applies its Nucleosomics platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose a range of cancers and other diseases, reported the pricing of its underwritten public offering of 3,809,524 shares of its common stock (the "Offering") for gross proceeds of approximately $20 million, before deducting the underwriting commissions and other estimated offering expenses payable by Volition (Press release, VolitionRX, FEB 10, 2021, View Source [SID1234574878]). All of the shares to be sold in the Offering will be sold by Volition, subject to customary closing conditions. The Offering is expected to close on or about February 12, 2021, subject to customary closing conditions. In addition, Volition has granted the underwriter for the Offering a 30-day option to purchase up to an additional 571,428 shares of its common stock.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Fitzgerald & Co. is acting as the sole book running manager of the Offering.

The underwriter may offer the shares from time to time for sale in one or more transactions on the NYSE American market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On February 9, 2021, the last sale price of the shares as reported on the NYSE American was $6.27 per share.

Volition intends to use the net proceeds of the Offering for general corporate purposes, which may include continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.

The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227248) previously filed by Volition with the Securities and Exchange Commission (the "SEC") on September 26, 2018 and declared effective by the SEC on September 28, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering has been filed with the SEC. The final prospectus supplement relating to and describing the final terms of the Offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov.

Before you invest, you should read the registration statement, the prospectus supplement and accompanying prospectus, the documents that Volition has filed with the SEC that are incorporated by reference into the registration statement, and the other documents Volition has filed with the SEC for more complete information about Volition and the Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected].

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

On February 10, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the fourth quarter and full year ended December 31, 2020 (Press release, Vanda Pharmaceuticals, FEB 10, 2021, View Source [SID1234574877]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am very proud of the significant accomplishments we realized during this challenging year," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "As we look forward to the new year, it is worth noting some of our significant accomplishments from 2020: Vanda achieved record commercial revenue despite extraordinary difficulty in the field, which we believe is a testament to the value our products bring to patients; HETLIOZ received FDA approval for nighttime sleep disturbances in patients with Smith-Magenis Syndrome; our tradipitant gastroparesis Phase III study continued recruitment; the FDA approved individual Expanded Access to tradipitant for multiple gastroparesis patients; we launched the tradipitant study for COVID-19 pneumonia; the FDA approved the Investigational New Drug application for VSJ-110 in allergic conjunctivitis; the United States Supreme Court affirmed the patent ruling on Fanapt; and our research and development efforts advanced the clinical programs for our commercial assets as well as those in our pipeline. We look forward to another great year of accomplishments, including further revenue growth, the commercial launch of HETLIOZ in patients with Smith-Magenis Syndrome, and the results of the tradipitant Phase III study in gastroparesis, to highlight a few."

Key Financial and Corporate Highlights

Fourth Quarter of 2020

Total net product sales from HETLIOZ and Fanapt were $67.7 million in the fourth quarter of 2020, an 11% increase compared to $60.9 million in the fourth quarter of 2019.
HETLIOZ net product sales were $44.2 million in the fourth quarter of 2020, a 14% increase compared to $38.6 million in the fourth quarter of 2019.
Fanapt net product sales were $23.5 million in the fourth quarter of 2020, a 5% increase compared to $22.3 million in the fourth quarter of 2019.
Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019.
Full Year 2020

Total net product sales from HETLIOZ and Fanapt were $248.2 million for the full year 2020, a 9% increase compared to $227.2 million for the full year 2019.
HETLIOZ net product sales were $160.7 million for the full year 2020, a 12% increase compared to $143.0 million for the full year 2019.
Fanapt net product sales were $87.5 million for the full year 2020, a 4% increase compared to $84.2 million for the full year 2019.
Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019.
Cash, cash equivalents and marketable securities (Cash) was $367.7 million as of December 31, 2020, representing an increase to Cash of $55.6 million compared to December 31, 2019.
Key Product and Pipeline Highlights

Products

Vanda is encouraged by the strength of its commercial performance during the fourth quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt for schizophrenia direct-to-consumer campaign, which was launched in 2020. Vanda is continuing its activities to support and facilitate the treatment of individuals in the U.S. living with Smith-Magenis Syndrome (SMS), and is committed to its awareness campaign and the support of patients suffering with Non-24-Hour Sleep-Wake Disorder.

Pipeline

Tradipitant

The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study has a target enrollment of 200 randomized patients and is expected to complete enrollment in the first half of 2021, with a New Drug Application (NDA) filing projected in the second half of 2021.
The COVID-19 pneumonia Phase III clinical study (ODYSSEY VLY-686-3501) is ongoing.
HETLIOZ (tasimelteon)

In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in SMS.1 HETLIOZ capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021. SMS is estimated to affect 1/15,000-25,000 births in the U.S.2 HETLIOZ is the first and only FDA approved medication for patients with SMS.
A Phase III clinical study for HETLIOZ in delayed sleep phase disorder (DSPD) is expected to be initiated in the first quarter of 2021.
A clinical development program for HETLIOZ in autism spectrum disorder (ASD) is expected to be initiated in the first quarter of 2021.
Fanapt (iloperidone)

Development of the long acting injectable (LAI) formulation of Fanapt is ongoing.
A clinical program for Fanapt in Parkinson’s disease psychosis (PDP) is expected to begin in the first quarter of 2021.
GAAP Financial Results

Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019. Net income was $8.2 million in the fourth quarter of 2020 compared to net income of $4.2 million in the fourth quarter of 2019. Diluted net income per share was $0.15 in the fourth quarter of 2020 compared to diluted net income per share of $0.08 in the fourth quarter of 2019.

Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019. Net income was $23.3 million for the full year 2020 compared to net income of $115.6 million for the full year 2019. The full year 2019 net income of $115.6 million and the 2019 income tax benefit of $86.5 million include the favorable impact of the release of Vanda’s deferred tax asset valuation allowance.

Diluted net income per share was $0.42 for the full year 2020 compared to diluted net income per share of $2.11 for the full year 2019.

2021 Financial Guidance

Vanda expects to achieve the following financial objectives in 2021:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, February 10, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the fourth quarter and full year 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 3557867. A replay of the call will be available on Wednesday, February 10, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, February 17, 2021 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 3557867.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

On February 10, 2021 Transcenta Holding Limited (Transcenta), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported the appointment of Dr. Michael Shi as Executive Vice President, Head of Global R&D and Chief Medical Officer (Press release, Transcenta, FEB 10, 2021, View Source [SID1234574876]). Dr. Shi will lead the global research and development of all our pipeline molecules and registration approvals. Dr. Li Xu, current acting Chief Medical Officer, will continue to help company and will serve on its scientific advisory board and as a strategic advisor to CEO.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Before joining Transcenta, Dr. Michael Shi was Global Program Clinical Head at Novartis Pharmaceuticals Corp. in East Hanover, New Jersey, USA. He played key leadership role in the clinical development of multiple novel oncology/hematology products, including Tabrecta (capmatinib), Zykadia (ceritinib), Adakveo (crizanlizumab), Exjade/Jadenu, BGJ398, TKI258 (dovitinib) and PDR001. Most recently, he led the development teams to achieve accelerated approval of Tabrecta and Zykadia in lung cancer indication and Adakveo in sickle cell disease, all under the US FDA breakthrough therapy designation.

"We are honored to have Dr. Shi joining the Transcenta team," said Dr. Xueming Qian, Co-Founder and CEO of Transcenta. "As a seasoned biopharmaceutical industrial expert, Dr. Shi worked extensively in the areas of clinical development, translational medicine, biomarker development, and discovery research in several well-known companies. He will lead our global clinical development and registration of all therapeutic area products."

"The biopharmaceutical industry has made great progress in China in recent years," said Dr. Shi. "As an integrated biopharmaceutical company focusing on innovative biological products, Transcenta has great potential. I’m very excited to join the company and look forward to accelerating the research and development of innovative biologic pipeline molecules with the excellent team, and benefiting patients around the world."

Dr. Shi received his medical education from Peking Union Medical College, a Ph.D. in Molecular Pharmacology and Toxicology from the University of Southern California and conducted a postdoctoral fellowship at Harvard Medical School. He also worked as the Program Director of Genetics Variation at NIH and an assistant professor at the University of Michigan Medical School.

On February 10, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its financial results for the full year 2020 (Press release, Ipsen, FEB 10, 2021, View Source;Focused-on-Executing-New-Strategy-and-Delivering-Financial-Objectives-in-2021 [SID1234574875]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Solid full year 2020 financial results in a COVID-19 environment
Group sales of €2.592 million, growing by 3.0%1 at constant currency or 0.6% as reported, driven by Specialty Care sales growth of 5.9%1, reflecting a resilient oncology portfolio, while Consumer Healthcare sales were down 21.3%1 mostly due to the impact of COVID-19.
Core Operating margin at 32.0% of the sales, up 1.6 points. IFRS Operating margin at 20.1% of the sales, up 21.4 points.
Core consolidated net profit of €610.5 million, with fully diluted Core EPS growing by 8.4% to reach €7.31. IFRS Consolidated net profit showing a gain of €548.9 million, with IFRS net earnings per share of €6.57.
Sound financial structure, with a closing Net Debt of €525.3 million and a Net Debt to EBITDA ratio of 0.6x. Strong Free Cash Flow at €646.4 million, up 38%, mainly driven by higher Operating Cash Flow.
Advancing solid pipeline in H2 2020
Cabometyx (cabozantinib) in combination with nivolumab for 1L renal cell carcinoma (RCC) filing with EMA based on successful Phase 3 CheckMate -9ER;
Onivyde (irinotecan liposome injection) received Fast Track designation from the FDA for 2L Small Cell Lung Cancer (SCLC);
Palovarotene on track for NDA and MAA submissions for fibrodysplasia ossificans progressiva (FOP).
Proposed dividend of €1.00 per share2 for the 2020 financial year, consistent with the prior year.
2021 guidance3 of Group sales growth greater than 4.0% at constant currency and Core Operating margin greater than 30.0% of the sales.
Executing on new strategy presented in December 2020: Focus. Together. For patients and society.
David Loew, Chief Executive Officer of Ipsen, stated: "I am truly proud of Ipsen’s performance in 2020. We met our financial objectives, delivering steady top-line growth, significant core operating margin expansion and strong cash flow generation to fund our external innovation strategy. The fact these achievements took place against the backdrop of the pandemic is remarkable and speaks to the dedication and patient-centricity of our highly motivated employees. We made encouraging pipeline progress, especially in Oncology. In December we announced our new strategy which will drive long-term value for all our stakeholders: Focus. Together. For patients & society. While the world continues to face uncertain business conditions in 2021, I am confident that Ipsen will build on its strong foundations and execute on its strategy to deliver another successful year."

New Strategy

Ipsen is executing on the four key pillars of its new strategy presented in December 2020:

The Group is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. It aims to maximize its core brands and capture the full potential of its innovative oncology products. A strategic review of the Consumer Healthcare business is proceeding.
Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.
The company is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.
Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

2021 Financial guidance

The Group has set the following financial targets for the current year, assuming a progressive recovery from COVID-19 by H2 2021:

Group sales growth year-on-year greater than 4.0% at constant currency1, with an expected negative 3.0% impact of currency based on the level of exchange rates at the end of January 2021;
Core Operating margin greater than 30.0% of the sales, excluding any potential impact of incremental investments from external innovation.
This guidance assumes a phased launch of lanreotide generic in Europe by mid-2021 and a limited impact in case of a potential launch of octreotide or lanreotide generics in the U.S.
Group sales reached €2,591.6 million, up 3.0%1 year-on-year.

Specialty Care sales reached €2,381.1 million, up 5.9%1, driven by the continued strong growth of Somatuline (lanreotide) and Cabometyx. Somatuline growth of 13.1%1 was driven by continued positive momentum in North America with a double-digit growth (17.0%1) and solid performance throughout Europe despite the availability of the octreotide generic. Dysport (botulinum toxin type A) down by 3.4%1, was impacted in most geographies by the closure of treatment centers resulting from COVID-19 despite a faster recovery in the aesthetics market. Decapeptyl (triptorelin) sales reflected good volume growth across Major European countries offset by lower volumes in China.

Consumer Healthcare sales reached €210.6 million, down 21.3%1, mainly due to a decline in Smecta (diosmectite) sales impacted by COVID-19, the implementation of hospital central procurement in China and lower performance in France.

Core Operating Income reached €829.3 million in 2020, compared to €782.6 million in 2019, a growth of 6.0%, driven by sales growth, Group-wide efficiencies and costs savings with less travel, medical and marketing expenses due to COVID-19 partially offset by continued investment in R&D to advance key programs in Oncology, Rare Disease and Neuroscience.

Core Operating margin reached 32.0% of the sales, up 1.6 points compared to 2019.

Core consolidated net profit was €610.5 million in 2020, an increase of 8.4% versus €563.4 million in 2019, driven by higher Core Operating Income.

Fully diluted Core EPS (earnings per share) grew by 8.4% to reach €7.31, compared to €6.74 in 2019.

IFRS Fully diluted EPS was a net profit per share amounting to €6.57 versus a net loss of €0.61 in 2019.

Free Cash Flow reached €646.4 million, up by €178.7 million, mainly driven by higher Operating Cash Flow thanks to a lower level of capital expenditures and working capital partly offset by higher cash out from restructuring costs, financial result and current income tax.

Closing net debt reached €525.3 million at the end of 2020, as compared to closing net debt in 2019 of €1,115.6 million.

Conference call

Ipsen will hold a conference call Thursday, 11 February 2021 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

On February 10, 2021 Advanced Chemotherapy Technologies, Inc., a clinical-stage drug delivery company, reported that it has closed a Series A investment of $2.5 million with Spectrum Financial (Press release, Advanced Chemotherapy Technologies, FEB 10, 2021, View Source [SID1234574874]). This investment is in addition to the previously announced Series A investment of $5.5 million lead by Khosla Venture. The capital will be used to fund initial clinical development of the company’s ACT-IOP-003 local chemotherapy system for the treatment of locally advanced non-resectable and borderline resectable pancreatic cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For pancreatic cancer, the ACT-IOP-003 system will be used to deliver the chemotherapy drug, gemcitabine, through the dense tumor microenvironment, directly to the tumor, while also minimizing the systemic toxicity commonly associated with chemotherapy treatments for pancreatic cancer. This approach offers three major advantages over traditional systemic chemotherapy: (1) Superior delivery of chemotherapy to the tumor cells, greatly increasing the amount of drug to treat the tumor, (2) Tumor shrinkage that can enable surgical resection, the only curative treatment for pancreatic cancer, and (3) Greatly decreased systemic toxicity so that the patient can remain in treatment.

This novel implantable drug delivery system uses a mild electrical current (iontophoresis) and can deliver a wide range of drugs directly to the local tumor. The system was developed in the laboratories of Jen Jen Yeh, MD, and Joseph M. DeSimone, PhD, at the University of North Carolina (UNC) at Chapel Hill. In preclinical studies, 100% of pancreatic cancer tumors treated with the device using gemcitabine shrunk by an average of 40%, while tumors treated with intraveneously delivered gemcitabine grew an average of 240%.

"We are excited to invest behind ACT to help bring their first product to market. ACT-IOP-003 is disruptive technology that will change the cancer treatment landscape and lead to breakthroughs for patients," said Bryan Martin, Chief Investment Officer of Spectrum Financial. "We believe that the Advanced Chemotherapy Technology team has developed a truly innovative technology that holds promise to significantly improve outcomes for pancreatic cancer patients."

"We are thrilled to bring on additional investors of the quality of Spectrum Financial. Closing additional Series A funding, during these uncertain times, further validates Advanced Chemotherapy Technologies disruptive approach to local drug delivery for treating solid tumors. This funding accelerates our ability to start clinical trials for our lead product in pancreatic tumors, one of the deadlist of all cancers," said Tony Voiers, CEO of Advanced Chemotherapy Technologies.