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Galectin Therapeutics Appoints Seasoned Biopharmaceutical Executive Pol F. Boudes, M.D. as Chief Medical Officer

On February 20, 2020 Galectin Therapeutics Inc. (NASDAQ:GALT), a leader in the field of NASH therapeutics, reported the appointment of Pol F. Boudes, M.D. to the position of Chief Medical Officer (Press release, Galectin Therapeutics, FEB 20, 2020, View Source [SID1234554564]). In this position, Dr. Boudes will oversee Galectin’s global advanced clinical development of belapectin (GR-MD-02) for NASH cirrhosis, as well as all other company clinical and scientific initiatives. Dr. Boudes brings more than 25 years of experience in clinical drug development in liver-related diseases — most recently NASH — and immunology, endocrine, metabolic and orphan diseases.

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"Strengthening our executive team is a key development for the company, enhancing our future growth trajectory as we near launch of our NASH-RX trial, an adaptively-designed Phase 3 trial in NASH cirrhosis," said Dr. Harold H. Shlevin, CEO. "Dr Boudes’s diverse background in drug development, especially his experience in NASH and in related diseases, adds an important layer of expertise in relevant therapeutic areas and bolsters our ability to advance the development of our galectin-3 product assets. We are excited to have him join our team."

Chairman of Galectin, Mr. Richard E. Uihlein said, "On behalf of myself and the entire board, we are extremely pleased to have such a high quality Chief Medical Officer joining our excellent team. We believe the hiring of Dr. Boudes demonstrates the continued optimism and focus we collectively have on advancing our drug candidate through the planned upcoming trial in an effective and efficient manner."

Dr. Boudes will report directly to Galectin’s CEO Harold Shlevin, PhD. and serve as a member of the company’s executive management team.

"I am very excited to join at such an important moment," said Dr. Boudes. "The team at Galectin has done a remarkable job to advance the belapectin program with the planned initiation of a well-designed and innovative late-stage adaptive study. The drug candidate is anchored on a well-understood mechanism of action, and its effect in preventing the development of esophageal varices, if confirmed, could constitute a breakthrough for patients suffering from NASH cirrhosis and; potentially, other types of liver cirrhosis and other organ fibrosis." Dr. Boudes added, "It will also be an honor to work under the guidance of such an experienced and supportive board of directors."

Most recently, Dr. Boudes was CMO at CymaBay Therapeutics, where he worked on the company’s proprietary NASH compound and was instrumental in inventing and launching programs in rare liver diseases. Prior to CymaBay, Dr. Boudes was CMO at Amicus Therapeutics, a company focusing on rare lysosomal storage disorders. Following this experience, Dr. Boudes became a board member of Protalix BioTherapeutics, a company developing plant cell expressed recombinant proteins with improved therapeutic profiles, notably for lysosomal disorders. Additionally, he’s held positions of increased responsibilities in clinical development at Bayer HealthCare Pharmaceuticals, Wyeth Research, Hoffman-La Roche and Pasteur Merieux. Dr. Boudes has contributed to the approval of multiple drugs, both in the US and globally, across a variety of therapeutic indications.

A dual citizen of the US and France, Dr. Boudes earned his MD at the University of Marseilles, France. He completed his internship and residency in Marseilles and Paris and was an Assistant Professor of Medicine at the University of Paris. In this capacity he also participated in multiple clinical research programs as an investigator. He is certified by the Educational Commission for Foreign Medical Graduates (US) and board-specialized in endocrinology and metabolic diseases, internal medicine, as well as in geriatric diseases (Paris).

Dr. Boudes holds several records of invention and has contributed to multiple peer-reviewed publications, notably on improving the clinical development process. He served on the editorial review board for La Revue Prescrire, a leading European Drug Therapeutic Bulletin, and on several scientific advisory boards for drug development. He is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of Liver (Geneva, Switzerland), the American Diabetes Association, the Royal Society of Medicine (London, U.K.), and the American Medical Association.

Intellia Therapeutics to Hold Conference Call to Discuss Fourth Quarter and Full-Year 2019 Earnings and Company Update

On February 20, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present fourth quarter and full-year 2019 financial results and operational highlights in a conference call on February 27, 2020 at 8 a.m. ET (Press release, Intellia Therapeutics, FEB 20, 2020, View Source [SID1234554563]).

To join the call:

U.S. callers should dial 1-877-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10138773, approximately five minutes before the call.
A replay of the call will be available through the Events and Presentations page of the Investor Relations section of the company’s website at www.intelliatx.com, beginning on February 27, 2020 at 12 p.m. ET.

Akari Therapeutics, Plc Announces Private Placement

On February 20, 2020 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported that it has entered into definitive agreements with certain accredited investors, the majority of whom are existing investors of the Company, including Dr. Ray Prudo, Akari’s Chairman, to receive gross proceeds of approximately $6 million through the private placement of its equity securities (Press release, Akari Therapeutics, FEB 20, 2020, View Source [SID1234554562]).

In connection with the offering, the Company will issue unregistered American Depository Shares (ADSs) at a purchase price of $1.70 per ADS. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one-half ADS. The warrants will have an exercise price of $2.20 per ADS, will be exercisable upon their issuance and will expire five years from the issuance date. The closing of the offering is expected to take place during or before the week of February 24, 2020, subject to the satisfaction of customary closing conditions.

Paulson Investment Company, LLC, is acting as the exclusive placement agent in connection with this offering.

The ADS and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon exercise of the warrants, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Puma Biotechnology Reports Fourth Quarter and Full Year Financial Results

On February 20, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Puma Biotechnology, FEB 20, 2020, View Source [SID1234554561]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2019, compared to the fourth quarter and full year 2018.

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the fourth quarter of 2019 was $58.7 million, compared to net product revenue of $61.1 million in the fourth quarter of 2018. Net product revenue for the full year 2019 was $211.6 million, compared to net product revenue of $200.5 million for the full year 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $11.2 million, or $0.29 per share, for the fourth quarter of 2019, compared to a net loss of $30.7 million, or $0.80 per share, for the fourth quarter of 2018. Net loss for the full year 2019 was $75.6 million, or $1.95 per share, compared to $113.6 million, or $2.99 per share, for the full year 2018.

Non-GAAP adjusted net income was $0.3 million, or $0.01 per share, for the fourth quarter of 2019, compared to non-GAAP adjusted net loss of $12.2 million, or $0.32 per share, for the fourth quarter of 2018. Non-GAAP adjusted net loss for the full year 2019 was $18.3 million, or $0.47 per share, compared to non-GAAP adjusted net loss of $26.7 million, or $0.70 per share, for the full year 2018. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2019 was $1.6 million, compared to net cash provided by operating activities of $7.1 million for the fourth quarter of 2018. Net cash provided by operating activities for the full year 2019 was $22.4 million, compared to net cash used in operating activities of $24.1 million for the full year 2018. At December 31, 2019, Puma had cash, cash equivalents and marketable securities of $111.6 million, compared to $165.4 million at December 31, 2018.

"During 2019, Puma made broad strides to increase global commercial access to NERLYNX by HER2-positive breast cancer patients, as well as to expand the label and potential therapeutic indications of NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our year concluded with a label expansion to address NERLYNX side effects, registration approval in Hong Kong and marketing approval in Singapore for NERLYNX, an expanded license agreement with Pierre Fabre, as well as several clinical data presentations at SABCS. We believe these regulatory, commercial, partnering and clinical milestones position Puma for improved results in 2020 and beyond."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) modifying the SUMMIT basket trial to expand the HER2-mutated breast cancer cohort in the first quarter of 2020; (ii) receiving a [U.S.] regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in the second quarter of 2020; (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the fourth quarter of 2020; (iv) reporting Phase II data from the HER-positive breast and cervical cancer cohorts from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (v) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (vi) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the fourth quarter of 2019, total revenue was $62.9 million, of which $58.7 million was net product revenue, $4.0 million was license revenue received from Puma’s sub-licensees, and $0.2 million was royalty revenue. This compares to total revenue of $71.1 million in the fourth quarter of 2018, of which $61.1 million was net product revenue and $10.0 million was license revenue received from Puma’s sub-licensees. For the year ended December 31, 2019, total revenue was $272.3 million, of which $211.6 million was net product revenue, $60.3 million was license revenue received from Puma’s sub-licensees and $0.4 million was royalty revenue. This compares to total revenue of $251.0 million for the year ended December 31, 2018, of which $200.5 million was net product revenue and $50.5 million was license revenue received from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $71.6 million for the fourth quarter of 2019, compared to $89.7 million for the fourth quarter of 2018. Total operating costs and expenses were $311.4 million for the full year 2019 compared to $345.7 million for the full year 2018.

Cost of Sales

Cost of sales was $10.1 million for the fourth quarter of 2019 and $36.8 million for the full year 2019, compared to $10.3 million for the fourth quarter of 2018 and $34.6 million for the full year 2018.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $31.3 million for the fourth quarter of 2019, compared to $41.0 million for the fourth quarter of 2018. Selling, general and administrative expenses for the full year 2019 were $141.7 million, compared to $146.2 million for full year 2018, a decrease of approximately $4.5 million. The decrease in SG&A expenses for the full year 2019 primarily related to decreases in stock-based compensation expense of approximately $7.0 million, and payroll and related costs of approximately $1.3 million. These decreases were partially offset by an increase in professional fees and expenses of approximately $2.7 million and an impairment loss of approximately $1.2 million.

Research and Development Expenses

Research and development expenses were $30.2 million for the fourth quarter of 2019, compared to $38.4 million for the fourth quarter of 2018. Research and development expenses for the full year 2019 were $132.9 million, compared to $164.9 million for the full year 2018. The decrease of approximately $32.0 million for the full year 2019 resulted primarily from decreases in stock-based compensation expense of approximately $22.6 million, internal R&D expense of approximately $4.7 million, clinical trial expenses of approximately $4.2 million, and consultant and contractor costs of approximately $0.5 million.

Total Other Income (Expenses)

Total other expenses were $2.5 million for the fourth quarter of 2019, compared to $12.1 million for the fourth quarter of 2018. Total other expenses were $36.5 million for the year ended December 31, 2019, compared to $18.9 million for the year ended December 31, 2018. The increase of $17.6 million during the full year 2019 compared to the full year 2018 primarily resulted from an increase in debt extinguishment loss of approximately $8.1 million, an increase in legal verdict expense of approximately $7.4 million, and an increase in interest expense of approximately $4.0 million, partially offset by an increase in interest and other income of approximately $1.9 million.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 20, 2020. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

PRA Health Sciences, Inc. Reports Fourth Quarter and Full Year 2019 Results and Provides First Quarter and Full Year 2020 Guidance

On February 20, 2020 PRA Health Sciences, Inc. ("PRA" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter and year ended December 31, 2019 (Press release, PRA Health Sciences, FEB 20, 2020, View Source [SID1234554560]).

"We are pleased with our financial results for the quarter and are delighted to have delivered double digit constant currency revenue growth and double digit adjusted earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the year, we strengthened our leadership in Strategic Solutions, Product Registration, and Symphony Health and we believe we are very well positioned for the coming year. In 2020, we will continue to focus on our key strategic initiatives and to providing broad and flexible services to our clients."

Net new business for our Clinical Research segment for the three months ended December 31, 2019 was $658.9 million, representing a net book-to-bill ratio of 1.21 for the period. This net new business contributed to an ending backlog of $4.7 billion at December 31, 2019.

For the three months ended December 31, 2019, revenue was $800.2 million, which represents growth of 9.7%, or $70.6 million, compared to the fourth quarter of 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $74.5 million, an increase of 10.2% compared to the fourth quarter of 2018. By segment, the Clinical Research segment generated revenues of $725.1 million, while the Data Solutions segment generated revenues of $75.1 million.

Direct costs, exclusive of depreciation and amortization, were $386.1 million during the three months ended December 31, 2019 compared to $365.7 million for the three months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased by $24.7 million compared to the fourth quarter of 2018. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 48.2% of revenue during the fourth quarter of 2019 compared to 50.1% of revenue during the fourth quarter of 2018.

Selling, general and administrative expenses were $103.5 million during the three months ended December 31, 2019 compared to $96.4 million for the three months ended December 31, 2018. Selling,

general and administrative costs were 12.9% of revenue during the fourth quarter of 2019 compared to 13.2% of revenue during the fourth quarter of 2018.

GAAP net income attributable to PRA was $74.8 million for the three months ended December 31, 2019, or $1.16 per share on a diluted basis, compared to $71.5 million for the three months ended December 31, 2018, or $1.07 per share on a diluted basis.

EBITDA was $124.9 million for both the three months ended December 31, 2019 and December 31, 2018. Adjusted EBITDA was $148.5 million for the three months ended December 31, 2019, representing growth of 9.0% compared to the three months ended December 31, 2018.

Adjusted net income was $98.7 million for the three months ended December 31, 2019, representing 13.6% growth compared to the three months ended December 31, 2018. Adjusted net income for the three months ended December 31, 2019 includes the effects of a reduction in our effective tax rate from 24% to 23%. The decrease in our effective tax rate is primarily attributable to the geographic distribution of our pre-tax earnings. Adjusted net income per diluted share was $1.54 for the three months ended December 31, 2019, representing 17.6% growth compared to the three months ended December 31, 2018.

Full Year 2019 Financial Highlights

For the twelve months ended December 31, 2019, revenue was $3,066.3 million, which represents growth of 6.8%, or $194.3 million, compared to the twelve months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $225.2 million, representing growth of 7.8% compared to the twelve months ended December 31, 2018. By segment, the Clinical Research segment generated revenues of $2,813.0 million, while the Data Solutions segment generated revenues of $253.3 million.

GAAP income from operations was $363.9 million. GAAP net income attributable to PRA was $243.0 million, or $3.68 per share on a diluted basis, for the twelve months ended December 31, 2019.

Adjusted net income was $341.0 million for the twelve months ended December 31, 2019, an improvement of 20.0% compared to the twelve months ended December 31, 2018. Adjusted net income per diluted share was $5.17 for the twelve months ended December 31, 2019, up 20.8% compared to the twelve months ended December 31, 2018.

Full Year 2020 and Q1 2020 Guidance

For full year 2020, the Company expects to achieve total revenues between $3.23 billion and $3.36 billion, representing as reported and constant currency growth of 5.0% to 9.5%.

We expect GAAP net income per diluted share of between $4.01 and $4.21 per share and adjusted net income per diluted share of between $5.77 and $5.97 per share, representing growth of 12% to 15%. We anticipate an annual effective income tax rate estimate of 23%.

Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

For Q1 2020, the Company expects to achieve total revenues between $765.0 million and $787.0 million, representing as reported and constant currency growth of 6% to 9%. The Company expects GAAP net

income per diluted share of between $0.59 and $0.69 per share, adjusted net income per diluted share between $1.05 and $1.15 per share, and an annual effective income tax rate of 23%.

Our 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30 with all other foreign currencies using a rate as of January 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share and our 2020 guidance, to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on February 21, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 5667733. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 5667733.

Additional Information

A financial supplement with fourth quarter 2019 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q4 2019 Earnings Presentation."