CytomX to Present at the Bank of America Merrill Lynch 2018 Health Care Conference

On May 7, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported it will present at the Bank of America Merrill Lynch 2018 Health Care Conference (Press release, CytomX Therapeutics, MAY 7, 2018, View Source [SID1234527067]). Sean McCarthy, D.Phil., president and chief executive officer will deliver a corporate overview on May 17, 2018, at 10:40 a.m. P.T./ 1:40 p.m. ET.

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.

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

Cellular Biomedicine Group has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Aptose Exercises Early Option for CG-806 License From CrystalGenomics

On May 7, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported that Aptose exercised its option under the 2016 Option Agreement to exclusively license CG-806, a first-in-class, non-covalent pan-inhibitor of the Bruton’s tyrosine kinase (BTK) and FMS-like tyrosine kinase 3 (FLT3) from CrystalGenomics, Inc (Press release, CrystalGenomics, MAY 7, 2018, View Source [SID1234539163]). CG-806 is being developed as a highly potent, oral small molecule for acute myeloid leukemia (AML), B-Cell malignancies and other hematologic malignancies.

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With the early exercise of the option, Aptose owns global rights to develop and commercialize CG-806 for all indications outside of Korea and China – the Licensed Territory. The exercise triggers a payment of US $2.0 million to CrystalGenomics. CrystalGenomics is eligible for regulatory and sales milestone payments, as well as royalties on product sales in the Licensed Territory.

Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target all wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.

"CG-806 has the potential to serve as a transformational agent for AML, chronic lymphocytic leukemia (CLL) and other hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Recent pre-clinical studies, just highlighted at the 2018 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated CG-806’s superior potential to other FLT3 inhibitors on AML patient samples and superior potential to ibrutinib on CLL patient samples."

"Aptose has made the clinical development of CG-806 a priority, and we are pleased to be working with them," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "Aptose and its clinical advisors clearly recognize the potential of CG-806 as an exciting therapeutic option for patients with AML, CLL and other malignancies."

Delcath Announces Initiation of Registrational Trial of Melphalan/HDS in Intrahepatic Cholangiocarcinoma

On May 7, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the Company has initiated its pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, MAY 7, 2018, View Source;p=RssLanding&cat=news&id=2347300 [SID1234526165]). Duke Medical Center in Durham, North Carolina is the first cancer center to open for patient enrollment. Dr. Sabino Zani, a surgical oncologist with Duke Medical Center, is serving as the principal investigator for the trial in the United States.

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The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. Under the terms of the SPA, the primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

"The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "The sequential design of the therapies under investigation in the trial will allow us to minimize capital investment requirements in 2018. We are also leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible, and intend to conduct the trial in a financially prudent manner. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company."

Diplomat Announces Strong 1st Quarter Financial Results

On May 7, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended March 31, 2018 (Press release, Diplomat Speciality Pharmacy, MAY 7, 2018, View Source [SID1234526166]). All comparisons, unless otherwise noted, are to the quarter ended March 31, 2017.

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First Quarter 2018 Highlights include:

Revenue of $1,342 million, compared to $1,079 million, an increase of 24%
Specialty segment revenue of $1,153 million, compared to $1,079 million
PBM segment revenue of $191 million, which was not part of the business in the prior year period
Specialty segment total prescriptions dispensed of 223,000, compared to 220,000
PBM segment total volume, adjusted to 30-day equivalent, of 2,181,000
Gross margin of 8.2% versus 7.9%
Specialty segment gross margin of 8.1% versus 7.9%
PBM segment gross margin of 9.2%
EPS of $(0.01) per diluted common share versus $0.06
Adjusted EPS of $0.20 versus $0.19
Adjusted EBITDA of $39.6 million, compared to $26.8 million
Adjusted EBITDA margin of 3.0% versus 2.5%
Net cash provided by operating activities was $48.6 million, compared to $44.3 million
Net debt, including contingent consideration, reduced to $601.5 million, from $648.7 million at December 31, 2017
Jeff Park, Interim CEO, commented "Diplomat reached a new high mark this quarter in which the incredible team we’ve built executed on our plan and achieved record revenues. Our first quarter demonstrated strong performance in both our Specialty segment and our PBM segment – relaunched last week under its new brand, CastiaRx. Our PBM integration has progressed rapidly, and as our innovation, growth and profitability initiatives continue to gain momentum, we believe we can drive substantial market share gains over time and generate long term value for all our stakeholders."

First Quarter Financial Summary:

Revenue for the first quarter of 2018 was $1,342 million, compared to $1,079 million in the first quarter of 2017, an increase of $263 million or 24%. Revenue was comprised of $1,153 million and $191 million from our Specialty segment and our newly formed Pharmacy Benefit Management ("PBM") segment, respectively. There was a $2.0 million inter-company elimination of revenue, and associated cost of sales, between the segments. The increase in our Specialty segment revenue was primarily driven by $31 million of revenue from our other acquisitions as well as manufacturer price increases, access to dispense drugs that were new in the past year and increased volume through payor relationships. These increases were partially offset by a decrease in hepatitis C business versus the prior year period and drug mix.

Gross profit in the first quarter of 2018 was $110.6 million and generated an 8.2% gross margin, compared to $85.0 million gross profit and 7.9% gross margin in the first quarter of 2017. Gross profit was comprised of $93.0 million and $17.6 million from our Specialty segment and PBM segment, respectively. The gross margin increase in the quarter was primarily due to the impact of our PBM acquisitions, which includes all contracts reflected on a net revenue basis with associated product and service cost of goods, as well as the impact of the acquired entities in our Specialty segment, and manufacturer price increases in the first quarter of 2018 versus the prior year period.

Selling, general, and administrative expenses ("SG&A") for the first quarter of 2018 were $101.9 million, an increase of $25.4 million, compared to $76.5 million in the first quarter of 2017. This increase is primarily driven by $11.5 million related to employee cost, including employee cost for our acquired entities and stock option compensation. Also contributing to the SG&A expense increase was a $7.5 million increase in amortization expense from definite-lived intangible assets, including the capitalized software for internal use, associated with our acquired entities and a one-time $2.1 million severance and merger and acquisition expense associated with our acquired entities. We also experienced increases in other SG&A; including, freight, building and equipment, travel, insurance, and other miscellaneous expenses.

Net (loss) income attributable to Diplomat for the first quarter of 2018 was $(0.5) million compared to $4.4 million in the first quarter of 2017. This decrease was primarily driven by an $8.4 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, partially offset by an income tax benefit of $0.9 million in the first quarter of 2018 versus income tax expense of $2.3 million in the prior year period. The income tax benefit during the first quarter of 2018 was inclusive of a $0.3 million excess tax benefit related to share-based awards. Adjusted EBITDA for the first quarter of 2018 was $39.6 million compared to $26.8 million in the first quarter of 2017, an increase of $12.8 million.

Earnings per share for the first quarter of 2018 was $(0.01), compared to $0.07 for the first quarter of 2017. On a diluted basis, earnings per share was $(0.01) in the first quarter of 2018, compared to $0.06 in the prior year period. Diluted non-GAAP adjusted earnings per share ("Adjusted EPS") was $0.20 in the first quarter of this year compared to $0.19 in the first quarter of 2017.

2018 Financial Outlook

For the full-year 2018, we are increasing our revenue guidance to account for the earlier than anticipated transition to account for revenue in our PBM segment on a gross basis. We are maintaining our previous financial guidance on all other financial measures:

Revenue between $5.5 and $5.9 billion, versus the previous range of $5.3 and $5.6 billion
Net income attributable to Diplomat between $4.5 and $13.0 million
Adjusted EBITDA between $164 and $170 million
Diluted EPS between $0.06 and $0.17
Adjusted EPS between $0.87 and $0.97
Our EPS and Adjusted EPS expectations assume approximately 74,900,000 weighted average common shares outstanding on a diluted basis and a tax rate of 24% and 27%, for the low- and high-end of the range, respectively, for the full year 2018, which could differ materially.

Earnings Conference Call Information

The Company will now hold a conference call to discuss its first quarter performance tomorrow morning, May 8, 2018, at 8:00 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (647-689-4450 for international callers) and referencing participant code 5178318 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is