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PharmaCyte Biotech Successfully Completes Pore Size Studies in Cell-in-a-Box® Capsules Used in Pancreatic Cancer Therapy

On May 9, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the "pore size studies" on its Cell-in-a Box capsules that are required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, MAY 9, 2018, View Source [SID1234526384]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, "PharmaCyte’s treatment for locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) utilizes genetically engineered live human cells that produce a particularly potent cytochrome P450 enzyme that is able to activate the chemotherapy prodrug ifosfamide. These cells are encapsulated using the Cell-in-a-Box technology, and the capsules are implanted near the cancerous tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor.

"Therefore, it is essential that the ifosfamide can easily and quickly enter the capsules so that it can be efficiently converted into the ifosfamide tumor-killing metabolite. It is equally important that this metabolite can then exit the capsules and destroy the tumor. The completed studies clearly demonstrate that this is the case and underscore the stability of the capsules over the freezing, transport and storage cycle."

As part of PharmaCyte’s Investigational New Drug Application (IND) for its clinical trial in patients with LAPC, the FDA required PharmaCyte to provide data showing that the size of the pores in the outer shell of the Cell-in-a-Box capsules is appropriate to allow ifosfamide to enter the interior of the capsules where the ifosfamide-activating cells are located. Additionally, PharmaCyte is required to provide data showing that the pores are also of appropriate size to allow the activated form of ifosfamide to leave the capsules.

The FDA also required PharmaCyte to conduct experiments to demonstrate that the pore size was not affected by the freezing and thawing process of the capsules. To provide the information required by the FDA, a series of laboratory experiments were performed with non-frozen and freshly thawed capsules that were previously frozen and that contained labelled particles. Each set of samples studied contained particles of a particular size, and the appropriate size range was covered by the series of experiments.

Both the release of the particles from the capsules over time and the accumulation of the particles outside the capsules over time were evaluated. The experiments clearly demonstrated that molecules of the size of ifosfamide or its activated cancer-killing form could pass through the capsule’s pores virtually instantaneously. Further, there was no difference detected in the release parameters between freshly produced capsules and those that had been frozen and then thawed.

PDL BioPharma Announces First Quarter 2018 Financial Results

On May 9, 2018 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the first quarter ended March 31, 2018 including (Press release, PDL BioPharma, MAY 9, 2018, View Source [SID1234526383]):

Total revenues of $38.5 million for the three months ended March 31, 2018.

GAAP diluted EPS of $0.01 for the three months ended March 31, 2018.

GAAP net income attributable to PDL’s shareholders of $1.6 million for the three months ended March 31, 2018.

Non-GAAP net income attributable to PDL’s shareholders of $13.4 million for the three months ended March 31, 2018. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 3 at the end of the release.

Revenue Highlights

Total revenues of $38.5 million for the three months ended March 31, 2018 included:
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Product revenues of $23.3 million, which consisted of $18.3 million from sales of Tekturna and Tekturna HCT in the United States, Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products) and $5.0 million for product sales of the LENSAR Laser System;
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Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $11.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed royalty asset;
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Royalties from PDL’s licensees to the Queen et al. patents of $2.8 million, which consisted of royalties earned on sales of Tysabri; and

Interest revenue from note receivable investment to CareView Communications of $0.7 million.

Total revenues decreased by 15 percent or $6.9 million for the three months ended March 31, 2018, when compared to the same period in 2017. The evolution of our revenues reflects PDL’s strategic shift to a specialty biopharmaceutical business model and the residual decline in royalty income from our expired Queen et al. patents.
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The 85 percent increase in product revenues was derived from the sales of the Noden Products and the LENSAR Laser System, the latter of which PDL did not begin to recognize until May 2017. Product revenues accounted for approximately 61 percent of total revenues compared to approximately 28 percent in the first quarter of 2017. Rasilez and Rasilez HCT revenues were $7.8 million, which was the first full quarter of revenue recognized from the ex-U.S. commercialization by Noden, having assumed commercialization from Novartis in November 2017;

PDL received $18.6 million in net cash royalties from its royalty rights in the first quarter of 2018, compared to $13.5 million for the same period of 2017. The increase in cash royalties is mainly due to royalties from Glumetza sold by Valeant Pharmaceuticals International, Inc., partially offset by the decrease of royalties from ARIAD Pharmaceuticals, Inc. as royalties ceased when the asset was sold in the first quarter of 2017;

Royalties from PDL’s licensees to the Queen et al. patents were 80 percent or $11.4 million lower than in the first quarter of 2017 as product supply of Tysabri manufactured prior to patent expiry in the United States have been extinguished and ex-U.S. product supplies are rapidly being exhausted; and
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The decrease in interest revenues was primarily due to the sale of the kaléo, Inc. note receivable in September 2017.

Operating Expense HighlightsOperating expenses were $34.2 million for the three months ended March 31, 2018, compared to $26.9 million for the same period of 2017. The increase in operating expenses for the three months ended March 31, 2018, as compared to the same period in 2017, was primarily a result of Noden Products and LENSAR contributing additional cost of product revenue of $5.6 million and $2.4 million, respectively, which was the result of increased revenue and recognition of costs of goods for ex-U.S. revenue from Noden Products and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017. Sales and marketing expenses at Noden and LENSAR increased an additional $1.4 million and $1.5 million, respectively, and research and development expenses increased an additional $0.6 million due to LENSAR clinical studies. These increases were partially offset by a decrease in the fair value of acquisition-related contingent consideration of $2.0 million, a decrease in research and development costs for the completion of a pediatric trial for Tekturna and a decrease in general and administration asset management and legal expenses related to the Merck litigation.

Recent Developments

Stock Repurchase Program

From April 1, 2018 to May 8, 2018, the Company repurchased approximately 2.8 million shares of its common stock under the share repurchase program at a weighted average price of $3.03 per share for a total of $8.4 million.

Since the inception of the share repurchase program in March 2018, the Company has repurchased approximately 4.2 million shares of its common stock for a total of $12.6 million.

Approximately $12.4 million remains available under the current share repurchase program.

Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $405.1 million at March 31, 2018, compared to $532.1 million at December 31, 2017. The change in cash balance for the quarter was primarily a result of PDL retiring the remaining $126.4 million of principal of its 4.0% Convertible Senior Notes due 2018 at their stated maturity by making a payment to the noteholders of $129.0 million, which included $2.6 million of accrued interest.

Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, May 9, 2018.

To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 1798597. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through one week following the call, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 1798597.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to the Investor Relations section and select "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

Onconova Therapeutics, Inc. to Provide Corporate Update and First Quarter 2018 Financial Results

On May 9, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, reported that the Company will release its first quarter 2018 financial results on May 15, 2018 before the market opens (Press release, Onconova, MAY 9, 2018, View Source [SID1234526382]). The Company will host a conference call on May 15, 2018 at 9:00 a.m. Eastern Time to discuss these results.

Interested parties may access the call by dialing toll-free (855) 428-5741 from the US or (210) 229-8823 internationally, and using conference ID 2573768.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at that link until August 31, 2018.

Neurocrine Biosciences to Present at the Bank of America Merrill Lynch 2018 Healthcare Conference

On May 9, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Bank of America Merrill Lynch 2018 Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Tuesday, May 15, 2018, in Las Vegas, Nevada. Kevin Gorman, CEO of Neurocrine Biosciences, will present at the conference (Press release, Neurocrine Biosciences, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348202 [SID1234526381]).

The live presentation will be webcast and may be accessed on the Company’s website under Investors at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

NantHealth Reports 2018 First-Quarter Financial Results

On May 9, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its first quarter ended March 31, 2018 (Press release, NantHealth, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348273 [SID1234526380]).

Molecular Analysis – Highlights

Expanded Molecular Analysis Portfolio: Molecular Analysis portfolio expanded to include proprietary blood-based tumor profiling services, with beta launch of 26-analyte profiling test.
In-Vitro Diagnostic (IVD) Filing with FDA for circulating free DNA (cfDNA) Liquid Biopsy Platform: In Q1 2018, the company submitted a medical device application with the FDA for its proprietary cfDNA liquid biopsy platform.
Commenced Beta Launch of GPS Ordering and Results Portal enabling ordering physicians to electronically receive GPS results and request molecular tumor board and Medical Affairs consultations.
Test Growth: The company reported 677 GPS Cancer commercial tests were ordered in Q1 2018, up from 606 in Q4 2017.
Key Publication: In Q2 2018, results of a company sponsored study were published in Oncotarget, a peer-reviewed bio-medical journal. The study results demonstrate the significant gains in accuracy by performing tumor/normal DNA and RNA sequencing and the risks associated with high error rates of tumor only sequencing. View Source Publication
New National GPS Cancer Payer: In Q1 2018, as previously announced, the company signed a new GPS Cancer reimbursement contract with a large, national healthcare IT company.
New Lab Services Arrangement: In Q1 2018, as previously announced, the company signed a laboratory services agreement with a 20+ facility hospital system for the availability of GPS Cancer testing to its patient community.
Expanded International Adoption: In Q1 2018, as previously announced, the company signed a strategic reseller agreement with a partner in the United Kingdom for the provision of molecular analysis services for clinical studies and other research initiatives.
FDA Submission: In Q1 2018, as previously announced, the company submitted a 510(k) premarket notification application to the FDA for tumor/normal DNA sequencing.
"We are excited about the opportunity to feature GPS Cancer and our new liquid biopsy platform in 11 presentations at next month’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, a significant and auspicious milestone for NantHealth," said Sandeep (Bobby) Reddy, M.D., Chief Medical Officer of NantHealth. "In conjunction with these presentations, we plan to unveil to the oncology community at ASCO (Free ASCO Whitepaper) and commence the commercial launch of our liquid biopsy test, a 26 analyte test for circulating-free DNA (cfDNA) and RNA (cfRNA) extracted from patient blood permits non-invasive detection of expressed biomarkers and monitoring of response to immunotherapies such as Keytruda or Opdivo or resistance to anti-androgens such as Xtandi."

Software and Services Highlights:

Payer Engagement (NaviNet):
In Q1 2018, NantHealth’s industry leading Document Exchange solution was upgraded to include an enhanced document viewer and the ability for payers to tag and categorize documents.
In Q1 2018, as previously announced, the company signed a three-year renewal contract with a total contract value of approximately $17 million.
Clinical Decision Support (Eviti):
In Q1 2018, introduced new dual eligibility features, enabling payers to concurrently manage dual membership patients covered under Medicare and Medicaid, and drug shortage configuration features that provide improved management of high cost drugs.
Connected Care:
In Q1 2018, released DeviceConX5.14 (MDE), the first MDI solution to adopt the Fast Healthcare Interoperability Resources (FHIR) standard.
In Q1 2018, released VitalsConX2.1, with support for offline mode, enabling clinicians to continue nurse rounding when connectivity is lost and to submit data to the EMR once connectivity is restored.
In Q2 2018, completed first CE Mark submission for the DeviceConX software platform.
"Our 2018 first quarter performance reflects a 17% increase in consolidated revenue and a substantially improved gross margin over the prior year period," said Paul Holt, Chief Financial Officer of NantHealth. "We were delighted to see continued growth of our SaaS business, with revenue increasing 9% over the same quarter last year. Our year over year improvement in operating results was positively impacted by our revenue growth and the restructuring program, implemented late last year."

Business and Financial Highlights

In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented below represent the company’s continuing operations.

The company adopted a new revenue recognition standard on January 1, 2018. Please note that the financial results presented below include both amounts "as presented," which reflect implementation of the new revenue recognition standard, as well as amounts prior to the impact of the new revenue recognition standard to allow for comparability against historical results. Starting in fiscal year 2019, the company will no longer present its GAAP and Non-GAAP financial results under the previous revenue recognition standard. For additional information and reconciliations of our financial results between the new and previous revenue recognition standard, see the additional tables included in this press release and in the company’s Form 10-Q to be filed with the Securities and Exchange Commission.

For the 2018 first quarter, total net revenue as presented was $22.3 million. Total 2018 first quarter net revenue prior to the impact of the new revenue recognition standard increased 14% to $21.7 million from $19.1 million in 2017 first quarter. Gross profit as presented was $11.2 million, or 50% of total net revenue. Gross profit prior to the impact of the new revenue recognition standard was $10.7 million, or 49% of total net revenue, compared with $7.6 million, or 40% of total net revenue, for the prior-year first quarter. Selling, general and administrative (SG&A) expenses as presented were $20.7 million. SG&A prior to the impact of the new revenue recognition standard was $21.2 million compared with $17.4 million. Research and development (R&D) expenses as presented was $5.2 million decreased from $8.9 million; the new revenue recognition standard did not impact R&D expenses.

Net loss from continuing operations, net of tax, as presented was $22.0 million, or $0.20 per share. Net loss from continuing operations, net of tax, prior to the impact of the new revenue recognition standard narrowed to $22.8 million, or $0.21 per share, from $28.1 million, or $0.23 per share for the 2017 first quarter. Loss from discontinued operations, net of tax, as presented was $193,000, or breakeven on per share basis, compared with $13.0 million, or $0.11 per share; the new revenue recognition standard did not impact loss from discontinued operations. Net loss as presented was $22.2 million, or $0.20 per share. Net loss prior to the impact of the new revenue recognition standard was $23.0 million, or $0.21 per share, compared with $41.1 million, or $0.34 per share, for 2017 first quarter.

Financial results for the 2018 first quarter included approximately $3.3 million loss from related party equity method investment including impairment loss, $2.7 million of stock-based compensation expense, $2.2 million of intangible amortization, and $1.2 million of non-cash interest expense related to convertible notes, totaling $0.09 per share. On a non-GAAP basis, adjusted net loss from continuing operations as presented was $13.5 million, or $0.12 per share, for the 2018 first quarter. On a non-GAAP basis, adjusted net loss from continuing operations prior to the impact of the new revenue recognition standard was $14.3 million, or $0.13 per share, compared with $18.8 million, or $0.15 per share, for the 2017 first quarter.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2018. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 8963439. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.