10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Galectin Therapeutics, MAY 15, 2017, View Source [SID1234519119])

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Diffusion Pharmaceuticals Provides Corporate Highlights and Reports Financial First Quarter 2017 Results

On May 15, 2017 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported financial results for the three months ended March 31, 2017 and provided an overview of recent corporate highlights (Press release, Diffusion Pharmaceuticals, MAY 15, 2017, View Source [SID1234519235]).

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David Kalergis, Chairman and Chief Executive Officer, stated, "With the completion of our recent private placement, we believe we are now well positioned to advance our clinical development strategy for our lead product candidate, trans sodium crocetinate (TSC). We are in dialogue with the U.S. FDA regarding the design of a Phase 3 trial of TSC in newly diagnosed inoperable GBM patients, and plan to complete a protocol review in the third quarter of 2017. Assuming FDA sign-off on final protocol design, the study is planned to initiate by the end of 2017."

Corporate Highlights

In March 2017, U.S. Patent 9,604,899 entitled "Bipolar Trans Carotenoid Salts and Their Uses" was granted by the United States Patent and Trademark Office. This patent expands the coverage of the therapeutic use of TSC and other related compounds to five hypoxia-related conditions including congestive heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD) and respiratory distress syndrome (RDS).

In March 2017, the Company raised aggregate gross proceeds of $25.0 million in an oversubscribed private placement of its Series A convertible preferred stock. At March 31, 2017, the Company had cash and cash equivalents of $12.2 million and an $8.3 million subscription receivable that was then received on April 3, 2017.

Three Months Ended March 31, 2017 Financial Results

Research and development expenses were $1.0 million for the three months ended March 31, 2017, compared to $2.4 million for the three months ended March 31, 2016. This decrease in research and development was attributable to a decrease in expenses related to the Company’s pancreatic cancer program and animal toxicology studies.

General and administrative expenses were $1.6 million for the three months ended March 31, 2017, compared to $3.9 million for the three months ended March 31, 2016. The decrease in general and administrative expenses was primarily attributable to a decrease in costs attributable to the reverse merger transaction in January 2016.

The Company recognized $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement for the three months ended March 31, 2017, which consisted of the change in fair value of the common stock warrants from issuance, the excess fair value of the common stock warrants over the gross cash proceeds from the Series A preferred stock offering, and placement agent commissions and other offering costs.

Net loss was $28.6 million for the three months ended March 31, 2017, compared to a net loss of $6.2 million for the three months ended March 31, 2016. For the quarter ended March 31, 2017, the net loss included $26.0 million in warrant related expenses (of which $25.6 million was non-cash related and fees netted against gross proceeds) associated with the private placement. For the three months ended March 31, 2017, net loss attributable to common shares was $28.7 million, which was inclusive of the dividend payable on the Series A convertible preferred stock.

Net cash used in operating activities for the three months ended March 31, 2017 was $3.4 million compared to $4.6 million during the three months ended March 31, 2016.

Thermo Fisher Scientific to Acquire Patheon, a Leading Contract Development and Manufacturing Organization (CDMO)

On May 15, 2017 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and Patheon N.V. (NYSE: PTHN), a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, reported that their boards of directors have approved Thermo Fisher’s acquisition of Patheon (Press release, Thermo Fisher Scientific, MAY 15, 2017, View Source [SID1234519129]). Thermo Fisher will commence a tender offer to acquire all of the issued and outstanding shares of Patheon for $35.00 per share in cash. The transaction represents a purchase price of approximately $7.2 billion, which includes the assumption of approximately $2.0 billion of net debt.

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Patheon provides comprehensive, integrated and highly customizable solutions as well as the expertise to help biopharmaceutical companies of all sizes satisfy complex development and manufacturing needs. It is a leader in the high-growth, $40 billion CDMO market, which is fueled by growing customer demand for end-to-end solutions, flexible and scalable capacity, and regulatory expertise. Patheon has an extensive network of state-of-the-art facilities primarily in North America and Europe, and approximately 9,000 professionals worldwide. The company generated 2016 revenue of approximately $1.9 billion and will become part of Thermo Fisher’s Laboratory Products and Services Segment.

"Patheon’s development and manufacturing capabilities are an excellent complement to our industry-leading offering for the biopharma market," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our combined capabilities will enhance our unique value proposition for these customers, create significant value for our shareholders and further accelerate our company’s growth."

James C. Mullen, chief executive officer of Patheon, said, "Over the past several years, we have increased our capabilities to become a leading CDMO provider in a highly fragmented market. We are confident that our combined offerings and Thermo Fisher’s proven track record of disciplined M&A and successful integrations will take our business to the next level."

Casper added, "We look forward to welcoming our new colleagues from Patheon to Thermo Fisher. Patheon’s commitment to quality and service excellence is directly aligned with our focus on helping our biopharma customers accelerate innovation and drive productivity."

Benefits of the Transaction

Patheon Provides Entry into the Attractive, High-growth CDMO Market. Patheon serves a large, fragmented market growing in the mid-single to high-single digits, which is fueled by strong demand for outsourcing services that allow customers to simplify their supply-chain networks. By offering both small- and large-molecule development and manufacturing solutions, the company helps customers reduce the time and cost of delivering medicines to market. Patheon has invested significantly to become a scale player in the CDMO market and extend its leadership position.

Combination Significantly Strengthens Thermo Fisher’s Unique Value Proposition for Pharmaceutical and Biotech Customers by Adding Highly Complementary Services. Thermo Fisher is the leading supplier to the biopharmaceutical industry, supporting research, clinical trials and production. It has become a trusted outsourcing partner by providing clinical trials logistics services over the past decade. Combining these capabilities with Patheon’s CDMO services will allow Thermo Fisher to be a stronger partner for pharmaceutical and biotech customers.

Creates Substantial Synergies and Positions Combined Company to Further Accelerate Growth. The combined company’s extensive and deep relationships in the biopharma industry will enable significant cross-selling opportunities. For example, having biologics development and manufacturing capabilities as well as bioproduction technologies in one company will allow Thermo Fisher to offer a more comprehensive portfolio to gain share with these customers.

Delivers Attractive Financial Benefits. The transaction is expected to be immediately and significantly accretive to Thermo Fisher’s adjusted EPS1 by $0.30 in the first full year after close. Thermo Fisher expects to realize total synergies of approximately $120 million by year three following the close, consisting of approximately $90 million of cost synergies and approximately $30 million of adjusted operating income1 benefit from revenue-related synergies.
Approvals and Financing

The transaction, which is expected to be completed by the end of 2017, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an Extraordinary General Meeting of Patheon’s shareholders, and completion of the tender offer. Thermo Fisher has entered into tender and support agreements with affiliates of JLL Partners and Royal DSM, whose collective holdings represent approximately 73% of Patheon shares, under which they will tender their shares in the transaction.

Thermo Fisher has obtained committed debt financing from Goldman Sachs Bank USA and Goldman Sachs Lending Partners LLC. The company expects to finance the purchase price with debt of approximately $5.2 billion and equity of approximately $2 billion. The offer is not subject to any financing condition.

Advisors

Goldman Sachs & Co. LLC is acting as financial advisor to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel. Morgan Stanley & Co. LLC is acting as financial advisor to Patheon, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS and adjusted operating income, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any regularity or predictability, tax provisions/benefits related to the previous items, benefits from tax credit carryforwards, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

Cellular Biomedicine Group (CBMG) Announces the Addition of a Second Clinical Site in the Expansion of its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for Its CARD-1 Trial in Patients with Non-Hodgkin Lymphoma (NHL)

On May 15, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the addition of a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL (Press release, Cellular Biomedicine Group, MAY 15, 2017, View Source [SID1234519124]). The Company and Shanghai Tongji Hospital (Tongji) are conducting a single arm, non-randomized study to evaluate the safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment (scFv) (41BB-CD3f)) therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL).

"Driven by Shanghai’s regional demand, Tongji’s CAR-T expertise, the requirement to confirm site to site consistency and our need to prepare for the next phase of a confirmatory clinical trial, the new trial will benefit patients in Shanghai and provide CBMG with incremental data in safety and tolerability of C-CAR011 in more chemorefractory and aggressive DLBCL patients comprised of unique histogenesis and those with the most common indolent form of non-Hodgkin lymphoma (NHL). " said Mr. Tony Liu, Chief Executive Officer for CBMG.

Mr. Tony Liu added, "Due to our robust clinical pipeline, we believe the Company’s stock is currently undervalued. The management and our scientific team are committed to delivering long-term clinical benefits to patients that have the potential to address very large cancer and knee osteoarthritis markets and create long-term value for shareholders. We believe that CBMG has one of the very few leading integrated chemistry, manufacturing, and controls (CMC) facilities in the world for a cell therapy company, which when fully built out in China, will have the manufacturing capacity to support the treatment of 10,000 cancer and 10,000 knee osteoarthritis patients per year. With a healthy balance sheet and an efficient deployment of capital that will enable CBMG to execute on its clinical developments over the next twelve months, we are well equipped to further our clinical trials including the addition of new cancer indications by adding more top cancer centers in China for DLBCL and ALL trials using our C-CAR011 product. As a reminder, each year China has approximately five million new cancer patients, which far surpasses the U.S. We are pleased with our CAR-T patient screening and trial enrollment progress thus far and are on track to share our topline clinical data in the fourth quarter of this year as it becomes available. We look forward to evaluating new interests in expanding our clinical development and CAR-T partnerships with leading hospitals in major cities in China."

2017 Business & Technology Highlights

● In 2016, commenced patient enrollment in China for its CARD-1 ("CAR-T Against DLBCL") Phase I clinical trial utilizing CBMG’s optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with refractory Diffuse Large B-cell Lymphoma (DLBCL);

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● Announced addition of second clinical trial site for its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for its CARD-1 Trial in patients with refractory Diffuse Large B-cell Lymphoma (DLBCL) in Shanghai with Tongji Hospital;

● Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);

● Received the first disbursement of $1.2 million in the $2.29 million grant by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;

● Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;

● Began construction of a new GMP facility in "Pharma Valley" in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;

● Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing, and form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

Preclinical data for reversible BTK inhibitor RXC005 presented at the 17th International Workshop of Chronic Lymphocytic Leukemia

On May 15, 2017 Redx Pharma Plc reported that preclinical efficacy data inmouse-models for its development candidate, RXC005, a reversible BTK inhibitor, has been presented in a poster session at the 17th International Workshop of Chronic Lymphocytic Leukemia (iwCLL) biennial meeting in New York City, U.S. on 14 May, 2017 (Press release, Redx Pharma, MAY 15, 2017, View Source [SID1234524749]).

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The poster, entitled "RXC005, a Potent and Selective, Reversible BTK Inhibitor Targeting both Wild-type and Mutant C481S BTK with Potent Efficacy in ABC-DLBCL Xenograft Mouse Models", demonstrated that RXC005 successfully inhibits wild-type BTK and C481S mutant BTK, as well as B-CellReceptor signalling in ABC-DLBCL cell lines and importantly primary CLL cells.

RXC005 was also shown to be highly selective and exhibits improved target specificity against other Tec and Src kinase family members. RXC005 demonstrated significant efficacy in ABC-DLBCL xenograft mouse models such as TMD8 and OCI-Ly10 cell lines. The poster can be found at View Source

Dr Neil Murray, Chief Executive Officer of Redx Pharma, commented: We are delighted to have presented further potent efficacy data for one of our lead development candidates, RXC005, at the prestigious iwCLL event in front of our peers and contemporaries.

Dr Richard Armer, Chief Scientific Officer of Redx Pharma, commented: The data presented is further validation of RXC005’s potential to target both wild-type and mutant BTK, an important emerging resistance mechanism in patients with CLL progression following ibrutinib treatment. With good target engagement demonstrated in the PK/PD studies and efficacy in mouse-models, we look forward to filing an IND/CTA in late 2017 to take RXC005 into the clinic.

Further Details:
XVII International Workshop of Chronic Lymphocytic Leukemia web site: View Source
Poster title: RXC005, a Potent and Selective, Reversible BTK Inhibitor Targeting both Wild-type and Mutant C481S BTK with Potent Efficacy in ABC-DLBCL Xenograft Mouse Models
Download the presentation poster: RXC005, a Potent and Selective, Reversible BTK Inhibitor