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.

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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.

On May 9, 2018 BioClin Therapeutics, Inc., a clinical stage drug development company developing a first-in-class anti-FGFR3 (fibroblast growth factor receptor 3) monoclonal antibody for metastatic bladder cancer, reported
expansion of its Series B financing to $50 million to broaden its clinical development activities (Press release, BioClin Therapeutics, MAY 9, 2018, View Source [SID1234526402]). New investors, Sectoral Asset Management and INKEF Capital, joined existing investors Sofinnova Ventures, Ysios Capital, HealthCap, Tekla Capital Management funds, and Life Sciences Partners (LSP) in the round. Since its founding, the company has raised a total of $79 million.

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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

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The proceeds from this financing will be used to advance the company’s lead development candidate, B-701, for the treatment of patients with metastatic bladder cancer, or metastatic urothelial carcinoma (mUC). "This financing supports our Phase 2 trials evaluating B-701 both as a single agent, as well as in combination with pembrolizumab and separately with docetaxel. We anticipate completing enrollment in these Phase 2 studies by the second half of 2018, with initial data expected by yearend," said Stephen Lau, CEO of BioClin Therapeutics.

"We are delighted that Sectoral Asset Management and INKEF Capital have joined the BioClin investor syndicate. The additional funding will allow the Company to move forward with the only targeted biologic specific for FGFR3 in clinical development for bladder cancer," said David Kabakoff of Sofinnova and board member of BioClin Therapeutics.

On May 9, 2018 Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, reported financial results for the first quarter ended March 31, 2018 (Press release, Pain Therapeutics, MAY 9, 2018, View Source [SID1234526317]). Net loss was $2.2 million, or $0.33 per share. This compared to a net loss of $2.7 million, or $0.42 per share, for the same period in the prior year. Cash and cash equivalents were $10.7 million as of March 31, 2018.

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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

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"FDA’s acceptance of the NDA filing for REMOXY ER in Q1 2018 is a milestone," said Remi Barbier, Chairman, President & CEO. "Our focus is now on REMOXY ER’s potential to receive marketing clearance later this year. As part of this focus, we are preparing a strategic and thorough presentation of our key data for an upcoming FDA Advisory Committee Meeting for REMOXY ER, scheduled for June 26th in Washington, DC. We also continue to maintain tight fiscal discipline, and to advance our early-stage programs with non-dilutive funding."

Financial Highlights for First Quarter 2018

Net loss for the quarter was $2.2 million, or a net loss per share of $0.33. This compared to a net loss of $2.7 million, or $0.42 per share, for the same period in the prior year, representing a 19% decrease.

Cash and cash equivalents were $10.7 million. This compared to $10.5 million in the prior quarter, representing a 2% increase. Cash and cash equivalents for the quarter includes $1.9 million of net proceeds raised through issuance of shares of our common stock under a Capital on DemandTM program with JonesTrading Institutional Services LLC.

We have no debt.

We believe existing capital resources are sufficient to meet our projected operating requirements for at least the next 12 months.

We received $0.4 million in research grant funding from the National Institutes of Health, recorded as a reduction in research and development expenses (R&D).

R&D expenses were $1.1 million. This compared to $1.4 million for the same period in the prior year, representing a 23% decrease. R&D expenses included non-cash stock related compensation costs of $0.4 million, versus $0.3 million for the same period in the prior year.

General and administrative (G&A) expenses were $1.1 million. This compared to $1.4 million for the same period in the prior year, representing a 20% decrease. G&A expenses included non-cash stock-related compensation costs of $0.5 million, versus $0.5 million for the same period in the prior year.

About REMOXY ER (extended-release oxycodone capsules CII)

REMOXY ER is in registration with the US Food and Drug Administration (FDA) as a new type of abuse-deterrent, twice-daily, capsule gel formulation of oral oxycodone, a strong opioid drug. REMOXY ER has physical/chemical properties intended to deter abuse and still provide 12 hours of steady pain relief when properly prescribed by physician and used appropriately by patients.

Studies were extensive. The clinical efficacy of REMOXY ER was established in a Phase III study conducted under a Special Protocol Assessment. In total, over 2,400 subjects were exposed to REMOXY ER in 30 clinical studies. 9,000 unique data points were generated from 11 lab studies. The assessment of REMOXY ER’s abuse deterrence is supported by data from FDA Category 1 (lab), Category 2 (pharmacokinetic) and Category 3 (human abuse potential) studies. In addition, in November 2017 the Company and FDA held a pre-NDA meeting to confirm the sufficiency of data included in the REMOXY ER NDA resubmission.

REMOXY ER has a thick, sticky, high viscosity, hydrophobic, gel formulation that abusers cannot cut, grate or divide into smaller discrete particle sizes. The gel formulation resists syringe-ability, injection, and rapid extraction in ingestible solvents. REMOXY ER’s high viscosity and adhesive properties also cause it to stick to tools and equipment used for abuse. When exposed to heat, REMOXY ER releases an irritant to the eyes and lungs. REMOXY ER resists dose-dumping when challenged by alcohol and common physical and chemical manipulations.

We are requesting marketing approval of REMOXY ER as an analgesic drug with properties that can be expected to deter against injection, snorting and inhalation/smoking routes of abuse.

REMOXY ER intends to address the public health epidemic related to prescription opioids by advancing the science of abuse deterrence, providing an additional treatment option for physicians and patients, and increasing the range of available abuse deterrent technologies.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Opioid overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

Our Pipeline of Drug Assets also Includes:
FENROCK (transdermal fentanyl patch system) – This is a proprietary, abuse-deterrent skin patch for severe pain. FENROCK is an early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).

PTI-125 – This proprietary, small molecule drug candidate is aimed at the treatment of Alzheimer’s disease. PTI-125 is a Phase I clinical-stage program, substantially funded by a research grant award from the National Institutes of Health (NIH).

PTI-125DX – This is a proprietary blood-based test to detect Alzheimer’s disease. PTI-125DX is an early-stage program, substantially funded by a research grant award from the NIH

On May 9, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported The Lancet Oncology publication of data on 30 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617 (Press release, Endocyte, MAY 9, 2018, View Source [SID1234526367]). Preliminary results of this open-label phase 2 investigator-initiated trial were previously announced at the 2017 ESMO (Free ESMO Whitepaper) Congress and presented by Professor Michael Hofman of the Peter MacCallum Cancer Centre (Melbourne, Australia).

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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

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"This more detailed publication was consistent with or improved from the summary results presented at ESMO (Free ESMO Whitepaper) last fall," said Mike Sherman, president and CEO of Endocyte. "The response rates demonstrated to date are encouraging, especially since no agent has been proven to improve survival in this heavily pre-treated patient population. We look forward to beginning enrollment in our global phase 3 VISION trial of 177Lu-PSMA-617 this quarter."

Mr. Sherman continued, "We also look forward to Professor Hofman presenting additional updates at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, with new data from the trial’s expansion to 50 patients. Given the expected immaturity of survival data in the additional 20 patients, our focus will be on the PSA and RECIST response rates."

Updated Data Disclosed in The Lancet Oncology

The journal article published today in The Lancet Oncology reviews the design and results to date of the original 30 patients from this phase 2 trial. This publication provides a more comprehensive summary than previously disclosed of patient characteristics, treatment regimen and more mature outcome data, including updated Kaplan-Meier curves estimating overall survival and PSA progression-free survival (PFS) as well as a swimmer’s plot of the 30 patients.

This study evaluated a heavily pre-treated patient population, 87% of which had received > 1 line of prior chemotherapy (80% docetaxel and 47% cabazitaxel) and 83% received prior abiraterone acetate and/or enzalutamide.

Observations in this study include a PSA reduction of at least 50% from baseline (PSA50) in 57% of patients, a PSA reduction of at least 80% from baseline (PSA80) in 43% of patients and a PSA reduction of > 96% in 20% of patients who were identified as ‘exceptional responders’. Regarding disease progression and survival, a median PSA PFS of 7.6 months and a median overall survival (OS) of 13.5 months were observed. Both the median PSA PFS and the median OS reflect improved outcomes versus the 6.3 months and 12.7 months for each endpoint, respectively, previously presented at the 2017 ESMO (Free ESMO Whitepaper) Congress.

Notably, patients with a PSA50 response had median PSA PFS of 9.9 months and median OS of 17.0 months compared to PSA PFS of 4.1 months and median OS of 9.9 months for those who did not achieve a PSA50 response. Additionally, clinically meaningful improvements in quality of life measures were observed.

17 patients (57%) had prostate cancer working group 2 (PCWG2) RECIST 1.1 evaluable nodal or visceral target lesions following CT scan at baseline. Confirmed objective responses were seen in 14 (82%) of these 17 patients, including complete and partial response rates of 29% and 53%, respectively. This response rate is greater than the 71% PCWG2 RECIST 1.1 objective response rate previously reported.

177Lu-PSMA-617 was well tolerated, with no significant dose-limiting toxicities observed. The most common treatment-related toxicity was Grade 1 xerostomia (dry mouth) seen in 87% of patients, which is higher than previously reported (63%), but generally didn’t require any intervention. The occurrence of treatment-related Grade 3-4 hematologic toxicity was low and comparable to the largest retrospective published cohort.1

The paper is available online at the following link: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30198-0/supplemental

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

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]):

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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:
◦
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;
◦
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;
◦
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.
◦
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
◦
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.