On May 9, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported consolidated financial results for the fiscal 2019 second quarter ended March 31, 2019 (Press release, Applied DNA Sciences, MAY 9, 2019, View Source [SID1234536091]).

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"We successfully closed on a definitive agreement with TheraCann that contained the largest payment transaction in company history. This new revenue stream beachhead from legal cannabis sits beside the considerable progress we have made in driving adoption of our DNA technology platform and its commercialization across global textile industries," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our exclusive cannabis licensing and cooperation agreement with TheraCann secures $5 million in up-front payments by August 15, 2019 (of which $1 million has already been received) and includes annual minimum commitments that scale over time to $20 million in order to maintain the exclusive license. Powered by our CertainT platform, TheraCann’s ETCH biotrace system can offer the global legal cannabis and hemp industries what we believe is an unparalleled ability to ensure true authentication and provenance verification."

"Growing worldwide demand for legalized cannabis is driving the creation of global supply chains that need to be secured and validated from inception through consumption. TheraCann’s market position, together with our proven molecular tags and application and authentication systems, is yielding a pipeline of opportunities that spans interest from numerous countries wanting to protect their licensed cannabis supply chain to commercial trials for international export opportunities."

Continued Dr. Hayward, "Within our textile practice, our initiatives to further penetrate the very large synthetic fiber market are beginning to bear fruit. Initial volumes of goods tagged under our CertainT licensing platform are now appearing at retail via Amazon.com and on the store shelves of a big box retailer in North America. We are also executing on our strategy to engage key participants along multiple points in the global textile value chain to more broadly drive adoption of our platform. To that end, we are today involved in active pilot projects with fiber manufacturers that cumulatively represent approximately 50% of the annual global market for viscose. In cotton, after the close of the quarter, we announced our entry into the Egyptian cotton market to demonstrate the same level of authenticity and accountability to manufacturers of luxury Egyptian cotton products as we have to the U.S. cotton industry.

"Cannabis, textiles and our wholly-owned subsidiary, LineaRx are expected to drive our top-line performance for the balance of fiscal 2019 while we also progress nascent opportunities in other industries, including pharmaceuticals, " concluded Dr. Hayward. "We believe market trends are becoming tailwinds for us: sustainability in manufacturing is becoming increasingly relevant to today’s consumer, and manufacturers are seeking to elevate brands and products by establishing the transparency and truth that consumers desire. Our DNA technology platform can be the basis for the trust that both sides seek."

Fiscal Second Quarter 2019 Financial Results:

Revenues decreased 25% for the second quarter of fiscal 2019 to $778 thousand, compared with $1.0 million reported in the second quarter of fiscal 2018, and decreased 12% from the $884 thousand reported in the first fiscal quarter ended December 31, 2018. The year-over-year decrease in revenues was due primarily to a decrease in product revenues of $315 thousand from our biopharmaceutical and consumer asset marking verticals. The quarter-over-quarter decrease in revenues reflects the fulfillment of a cotton order during the first quarter of fiscal 2019.
Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $440 thousand and $830 thousand during the second quarter and first six months of fiscal 2019, respectively. These amounts were primarily comprised of the recognition of $383 thousand and $766 thousand during the three and six months periods ended March 31, 2019, respectively, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $494 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
Total operating expenses increased to $3.3 million for the second fiscal quarter of 2019, compared with $2.8 million in the prior fiscal year’s second quarter. This increase is primarily attributable to an increase in stock-based compensation expense.
Net loss for the quarter ended March 31, 2019 was $2.7 million, or $0.08 per share, compared with a net loss of $2.1 million, or $0.07 per share, for the quarter ended March 31, 2018 and a net loss of $3.2 million, or $0.11 per share for the quarter ended December 31, 2018.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.3 million for the quarters ended March 31, 2019 and 2018. See below for information regarding non-GAAP measures.
Six-Month Financial Highlights:

Revenues for the first six months of fiscal 2019 totaled $1.66 million, a decrease of 2% from $1.69 million from the same period in the prior fiscal year. The decrease in revenues was due to a decrease in product revenue of $343 thousand, or 41%, offset by an increase in service revenues of $315 thousand, or 37%.
Operating expenses for the six months ended March 31, 2019 increased by $902 thousand or 14% for the same period last fiscal year. The increase is primarily attributable to an increase in stock-based compensation, offset to a lesser extent by decreases in R&D and depreciation and amortization expenses.
Net loss for the six months ended March 31, 2019 was $5.9 million or $0.16 per share, compared with a net loss of $5.3 million or $0.18 per share for the six months ended March 31, 2018.
Excluding non-cash expenses and interest, Adjusted EBITDA for the six months ended March 31, 2019 was a negative $4.9 million as compared to a negative $5.1 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Select Recent Operational Highlights:

On May 7th, the Company and American & Effird ("A&E")announced that A&E will be previewing its new line of advanced molecular-tagged identification threads, branded "integrity", later this month. A&E will publicly display this latest breakthrough at the upcoming Texprocess show in Frankfurt Germany.
On April 29, 2019, Applied DNA’s wholly-owned subsidiary, LineaRx announced that it has improved expression levels and survival rates of linear DNA constructs delivered to human T cells without viruses or plasmids. In collaboration with Avectas, a cell engineering technology business enabling the manufacture of cell therapies, LineaRx has achieved a greater than four-fold increase in cell survival, and a more than 50% increase in linear gene expression of a model amplicon. Results were presented by Avectas two weeks ago at the Cell & Gene Meeting on the Mediterranean, attended by more than 50 companies.
On April 22, 2019, the Company and GHCL announced the launch of "REKOOP" on Amazon.com. REKOOP is verified by the Company’s CertainT platform. The "REKOOP" range of bedding products is meant for the ecologically conscious consumer who is making purchase decisions to support the environment and is supportive of initiatives that help reduce the carbon footprint.
On April 11, 2019, Applied DNA announced the signing of a non-binding MOU with Netherlands-based Stahl. Under the terms of the MOU, the parties will continue the evaluation of molecular tagging of process chemicals and coatings utilizing Stahl’s product offerings as a point of entry into supply chains for the Company’s molecular tags. Stahl will provide technical expertise to the company relating to the process chemicals used in leather manufacturing.
On April 8, 2019, the Company’ announced that its wholly owned subsidiary, LineaRx, achieved what it believes to be a biotech industry first with Anti-CD19 expression in human CAR T cells via proprietary non-viral, plasmid-free platform.
On April 2, 2019, Loftex, a leading manufacturer of high-quality towels, announced that the first retail introduction of their bath towels including recycled PET (rPET) source-verified by Applied DNA’s CertainT platform are now available at US retail this month. Loftex introduced the eco-friendly towel, partially comprised of rPET materials as part of their commitment to sustainability both in their factory and in their products.
On March 29, 2019, the Company signed an exclusive cannabis licensing and cooperation agreement with Theracann International. As part of the agreement, Applied DNA is to receive staged payments totaling $5 million by August 15, 2019. The Company announced that the first payment of $1 million was received during April 2019. The agreement also calls for annual payment minimums that scale from $7 million in year three to $20 million in year fifteen to maintain license exclusivity.
On March 1, 2019, Applied DNA announced that its wholly owned subsidiary, LineaRx and Takis/Evvivax are progressing linear DNA for use as a cancer vaccine. LineaRx shipped TK7 and ConTRT amplicons to Takis/Evvivax in early March as part of the companies’ Joint Development Agreement entered into during September 2018.
Fiscal Second Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2019 results on Thursday, May 9, 2019 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

Participant Toll Free: 1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through May 16, 2019):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10130964
Webcast replay: View Source
For those investors unable to attend the live call, a copy of the presentation is expected to be posted by end of business on May 10, 2019 and available under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On May 9, 2019 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results for the first quarter 2019 and provided a business update (Press release, Progenics Pharmaceuticals, MAY 9, 2019, View Source [SID1234536041]).

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"We are excited to report that the U.S. commercial launch of AZEDRA for the treatment of advanced or metastatic pheochromocytoma and paraganglioma is proceeding well and as expected. We will record our initial AZEDRA revenues in the second quarter," said Mark Baker, Chief Executive Officer of Progenics.

Mr. Baker continued, "We have also made excellent progress across our PSMA-targeted prostate cancer pipeline designed to find, fight and follow cancer. Today we announced that we have initiated our Phase 2 trial for 1095, our small molecule radiotherapeutic, and will begin actively enrolling patients in this important study this quarter. Our PyL program has been attracting increased interest from treating physicians based on the data highlighting PyL’s clinical utility and potential to improve treatment decision making. Our Phase 3 CONDOR study is enrolling ahead of schedule, with more than 50% of patients now enrolled, and the data presented earlier this week at American Urological Association’s Annual Meeting showcased PyL’s significant diagnostic advantages compared to traditional imaging modalities. We continue to partner with leading organizations worldwide, including Curium, in order to maximize the reach of our prostate cancer imaging agents and address unmet needs in the detection and therapeutic management of prostate cancer. We look forward to building on our positive momentum as we diligently execute our strategy to improve the lives of patients we serve and deliver value for our shareholders."

First Quarter and Recent Key Business Highlights

AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use, Ultra-orphan Radiotherapeutic

U.S. Launch of AZEDRA Progressing with 22 Treatment Requests from Patients Received and 12 Centers Throughout the U.S. are Ready to Treat Patients

AZEDRA is the first and only approved therapy in the U.S. for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. As of today, there are 12 multidisciplinary treatment centers across the U.S. activated for patient treatment and 22 treatment requests have been received and patients have been scheduled for treatment.

Progenics Announces First Quarter 2019 Financial Results Page 2

Pursuing Regulatory Path for Additional Indications for AZEDRA

The Company plans to meet with the U.S. Food and Drug Administration (FDA) in a life cycle management meeting to discuss a trial to support an expanded label for AZEDRA in multiple MIBG-avid tumors. Feedback from an advisory board meeting with leading physicians in February 2019 indicated support for a clinical study to research the use of AZEDRA in multiple MIBG-avid tumor indications, including gastroenteropancreatic neuroendocrine tumors ("GEP-NETS") and other neuroendocrine tumors ("NETS") given the high unmet medical need.

Upcoming AZEDRA Presentation at ASCO (Free ASCO Whitepaper)

At the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting in Chicago, Illinois, the abstract entitled, "Long-term Survival and Safety from a Multi-center, Open-label, Pivotal Phase 2 Study of Iobenguane I 131 in Patients (Pts) with Unresectable, Locally Advanced or Metastatic Pheochromocytoma or Paraganglioma (PPGL)" will be presented in a poster session on June 3, 2019.

Continued Progress Across Entire PSMA-Targeted Prostate Cancer Pipeline

Initiated Phase 2 Trial of 1095

Progenics has initiated a Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) and will begin enrolling patients within the quarter. Progenics’1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is highly expressed on prostate cancer cells. Based on the early data in this open label study, the Company will evaluate initiating a pivotal trial of 1095 in 2020.

Leveraging Investigator-Sponsored Studies to Expand and Advance PyL Development

As part of its PyL development strategy, Progenics is leveraging investigator-sponsored studies to expand clinical experience with the imaging agent and further demonstrate the candidate’s broad potential. Recent data from investigator-sponsored studies presented at the American Urological Association meeting and published in The Journal of Nuclear Medicine reinforce the potential of PyL to detect and monitor prostate cancer and inform treatment decisions. Progenics provides PyL to investigators for clinical research purposes via its PyL Access Program and through other initiatives.

Enrollment Ahead of Schedule in Ongoing Phase 3 Trial of PyL

The Company announced in December 2018 that the first patient was dosed in the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL. The Phase 3 CONDOR trial is a multi-center, open label trial that will enroll approximately 200 male patients with biochemical recurrence of prostate cancer in 14 sites in the United States and Canada. Patient enrollment for the trial is ahead of schedule and is expected to be completed in the fourth quarter of 2019. The Company plans to report data in early 2020. An abstract entitled "A Phase 3, Multicenter Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT in Men with Suspected Recurrence of Prostate Cancer (CONDOR)" will be presented in a poster session at ASCO (Free ASCO Whitepaper) on June 1, 2019.

Curium to Meet with EMA to Advance PyL in Europe

Curium, Progenics’ European PyL partner, has requested a scientific advice meeting with the European Medicines Agency (EMA) to discuss the regulatory path forward for PyL in Europe. Progenics entered into an exclusive license agreement in December 2018 with Curium for the development and commercialization of PyL in Europe in which Progenics would be entitled to royalties on net sales.

RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Bausch Health Companies, Inc.)

First Quarter 2019 RELISTOR Worldwide Net Sales of $27.7 Million

The first quarter 2019 worldwide net sales of RELISTOR, as reported by its partner Bausch Health Companies, Inc. (formerly known as Valeant Pharmaceuticals, Inc.), translated to $4.2 million in royalty revenue for Progenics for the quarter, up 36% over the first quarter of 2018.

Progenics Announces First Quarter 2019 Financial Results Page 3

Leronlimab (PRO 140), Monoclonal Antibody for HIV (owned and developed by CytoDyn, Inc.)

CytoDyn Files First of Three Sections of BLA for Leronlimab (PRO 140), an Anti-CCR5 Monoclonal Antibody for HIV Infection; Progenics is Entitled to Royalties and Milestone Payments

CytoDyn announced in March 2019 that it filed its first of three sections of its Biologics License Application (BLA) to the FDA for leronlimab for the treatment of HIV under the Rolling Review process. Leronlimab is a fully humanized, anti-CCR5 monoclonal antibody that Progenics sold to CytoDyn in 2012. Under the terms of the agreement, Progenics is eligible to receive an additional $5.0 million milestone payment upon U.S. or E.U. approval of the sale of the drug, as well as 5% royalty on net sales of the approved product.

First Quarter 2019 Financial Results

First quarter revenue totaled $4.3 million, up from $3.2 million in the first quarter of 2018, reflecting RELISTOR royalty income of $4.2 million compared to $3.1 million in the corresponding period of 2018.

First quarter research and development expenses increased by $4.3 million compared to the corresponding prior year period, resulting primarily from one-time transition costs for the AZEDRA manufacturing site and higher clinical and contract manufacturing costs for PyL. First quarter selling, general and administrative expenses increased by $2.5 million compared to the corresponding prior year period, primarily attributable to higher costs associated with the buildout of the commercial infrastructure to support the launch and distribution of AZEDRA and higher legal expenses. Progenics also recorded non-cash adjustments of $0.9 million in the first quarter 2019, related to changes in the fair value estimate of the contingent consideration liability. For the three months ended March 31, 2019, Progenics recognized interest expense of $1.1 million related to the RELISTOR royalty-backed loan.

Net loss for the first quarter was $18.7 million, or $0.22 per diluted share, compared to net loss of $13.4 million, or $0.19 per diluted share, in the corresponding 2018 period.

Progenics ended the first quarter with cash and cash equivalents of $109.6 million, a decrease of $28.1 million compared to cash and cash equivalents as of December 31, 2018, which includes approximately $10.8 million related to the acquisition, transition and start-up costs of the Somerset manufacturing site for the AZEDRA launch.

Conference Call and Webcast

Progenics will review first quarter 2019 results in a conference call today at 8:30 a.m. EST. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 5167901. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available there for two weeks.

Indication

AZEDRA (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Important Safety Information

Warnings and Precautions:

Risk from Radiation Exposure: AZEDRA contributes to a patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of AZEDRA are greater in pediatric patients than in adults. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with AZEDRA consistent with institutional good radiation safety practices and patient management procedures.

Myelosuppression: Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia. Monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range. Withhold and dose reduce AZEDRA as recommended in the prescribing information based on severity of the cytopenia.

Secondary myelodysplastic syndrome, leukemia, and other malignancies: Myelodysplastic syndrome (MDS) and acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed a non-hematological malignancy.

Hypothyroidism: Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications starting at least 1 day before and continuing for 10 days after each AZEDRA dose to reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate for clinical evidence of hypothyroidism and measure thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA and annually thereafter.

Elevations in blood pressure: Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension defined as an increase in systolic blood pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in diastolic blood pressure to ≥ 100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.

Renal toxicity: Of the 88 patients who received a therapeutic dose of AZEDRA, 9% developed renal failure or acute kidney injury and 22% demonstrated a clinically significant decrease in glomerular filtration rate (GFR) measured at 6 or 12 months. Monitor renal function during and after treatment with AZEDRA. Patients with baseline renal impairment may be at greater risk of toxicity; perform more frequent assessments of renal function in patients with mild or moderate impairment. AZEDRA has not been studied in patients with severe renal impairment.

Pneumonitis: Fatal pneumonitis occurred 9 weeks after a single dose in one patient in the expanded access program. Monitor patients for signs and symptoms of pneumonitis and treat appropriately.

Embryo-fetal toxicity: Based on its mechanism of action, AZEDRA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating AZEDRA. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AZEDRA and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose.

Progenics Announces First Quarter 2019 Financial Results Page 6

Risk of infertility: Radiation exposure associated with AZEDRA may cause infertility in males and females. Radiation absorbed by testes and ovaries from the recommended cumulative dose of AZEDRA is within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

Adverse Reactions:

The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (≥ 10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).

Drug Interactions:

Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.

For important risk and use information about AZEDRA, please see Full Prescribing Information.

To report suspected adverse reactions, contact Progenics Pharmaceuticals, Inc. at 844-668-3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference:

AZEDRA prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 08 2018 and 07 2018.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

IMPORTANT SAFETY INFORMATION – RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

Progenics Announces First Quarter 2019 Financial Results Page 7

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.

In the clinical studies, the most common adverse reactions were:

OIC in adult patients with chronic non-cancer pain

RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).

RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).

OIC in adult patients with advanced illness

RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

On May 9, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ended March 31, 2019 (Press release, Quanterix, MAY 9, 2019, View Source [SID1234536058]).

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"We’ve made strong progress over the past quarter, which now marks our sixth consecutive quarter since the IPO of accelerated growth. In addition, we are achieving important goals in neurology and now oncology with the launch of our new SP-X Imaging and Detection System" said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "There is mounting evidence supporting our Simoa technology’s potential to transform virtually every category of medicine. The extreme precision and sensitivity of our expanding portfolio of instruments and platforms is fueling new insights on drug targets, disease progression biomarkers and new opportunities for patient stratification for clinical trials, transforming traditional approaches to drug development and precision medicine."

First Quarter 2019 Financial Highlights

Key financial results for the first quarter are shown below:

·Q1 revenue of $12.3M versus prior year Q1 of $7.5M, an increase of 64%.

·Q1 instrument revenue of $3.4M versus prior year Q1 of $2.0M, an increase of 70%.

·Q1 consumables revenue was $6.1M versus prior year Q1 of $2.7M, an increase of 124%.

· Q1 Service and Other revenue totaled $2.8M versus prior year Q1 of $2.5M, an increase of 11%.

·Q1 gross margin was 48.7%, a 650 basis point improvement over the 42.2% in Q1 2018.

First Quarter 2019 Business Highlights

·Extended its footprint in oncology with the accelerated launch of its Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels to further revolutionize cancer research, immunotherapy monitoring, and drug development.

·Expanded its leadership team with the hiring of Amol Chaubal as Chief Financial Officer (CFO), formerly the CFO of Global Operations at Smith & Nephew and North America CFO – Novartis Vaccines & Diagnostics, bringing with him more than 20 years of experience in diagnostics, pharmaceutical services and medical devices.

· Increased citations in peer-reviewed publications of scientific research further validating Simoa’s capabilities in oncology and neurology with several groundbreaking studies, including a seminal study in Nature, which used Simoa to show that the biomarker LIF can be a reliable marker to help monitor the progression of pancreatic cancer. This was widely covered for its potential to help diagnose the disease more quickly and efficiently, and was proposed as a promising new target to assist in drug development. Another study using Simoa was published in Nature showing that elevated Nf-L levels were present in blood 16 years before the diagnosis of Alzheimer’s disease, demonstrating promise as part of an earlier diagnostic work-up. In total, Quanterix increased its number of third-party, peer-reviewed publications by 61, its strongest quarter ever, to a total of more than 500.

·Presented at the 37th Annual J.P. Morgan Healthcare Conference for the third year in a row, detailing Quanterix’ significant growth in its first year since becoming a public company.

· Presented and sponsored exhibits at critical industry conferences on the vital role of biomarkers to advance disease detection and therapeutics, including the 14th Annual Biomarkers Congress, Type 2 Immunity in Homeostasis and Disease, Molecular Med Tri-Con, 8th Global Reverse Phase Protein Array Workshop, the 14th International Conference on Alzheimer’s and Parkinson’s Diseases and American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference.

·Invited to speak at leading healthcare investor conferences including the 21st Annual Needham Growth Conference, the 8th Annual Leerink Partners Global Healthcare Conference, and the 39th Annual Cowen and Company Health Care Conference.

·Served as lead sponsor of the Boston, Mass. screening of "VINCIBLE The Documentary" — an inspiring true story that profiles the lives of several young adult cancer survivors who have lost their youth to the devastating disease.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 9, 2019, at 4:30 p.m., EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8955828.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On May 9, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the first quarter ended March 31, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, MAY 9, 2019, View Source [SID1234536075]).

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"The accomplishments and performance of UroGen during the first quarter have set the stage for a pivotal and exciting year ahead as we prepare for the potential approval and commercialization of UGN-101, our first investigational candidate. Our top priority remains completion of our rolling New Drug Application (NDA) for UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC) and, with our commercial preparations well underway, we are confident in our readiness to deliver on a strong launch in the first half of 2020," said Liz Barrett, President and Chief Executive Officer of UroGen. "Our company sees great possibilities for the RTGel platform within uro-oncology, especially around new therapeutic modalities. Our goal is to leverage that and continue to build a company with sustainable growth via a robust pipeline as well as assessing opportunities via external partnerships."

Recent Highlights

UGN-101 Clinical Development:

At the 114th American Urological Association (AUA) Annual Meeting in Chicago, Seth Lerner, M.D. delivered a presentation during the plenary session that highlighted the unmet need and potential for UGN-101 to change the treatment paradigm for patients with LG UTUC.

The updated analysis demonstrated that in the OLYMPUS intent-to-treat population, 71 patients had undergone primary disease evaluation (PDE) at the time of the analysis and 42 of the 71 patients (59 percent) achieved a complete response (CR). Forty-one patients entered follow-up. At the time of the analysis, 27 patients underwent a six-month evaluation, and 24 out of 27 patients (89 percent) have remained disease free at six months. The most common adverse events observed were urinary tract infection, ureteral narrowing and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved. Full Phase 3 data from the OLYMPUS trial is anticipated for 2H 2019.

The Company remains on track to complete its rolling NDA for UGN-101 in 2H 2019 and is planning for approval in 1H 2020. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC. Full data is planned for 2H 2019.

Pipeline Advancement:

UGN-102:

The Company continues to enroll patients in its Phase 2b OPTIMA II clinical trial of UGN-102 (mitomycin gel) for intravesical instillation as a first-line chemoablation agent in the treatment of patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC), a form of disease associated with a high risk of recurrence.

Initial data from the OPTIMA II trial of UGN-102 is expected in 2H 2019.

There are currently no drugs approved by the FDA as first-line treatment for LG NMIBC. UGN-102 represents a substantial opportunity in UroGen’s pipeline and has the potential to be a treatment option for up to approximately 80,000 patients for whom repetitive surgical resection via Transurethral Resection of Bladder Tumor (TURBT) remains the standard of care.

UGN-201:

UroGen is currently evaluating the optimal pathway to advance UGN-201, a TLR7/8 immunomodulatory agent for the treatment of high-grade bladder disease.

Commercial Preparations:

The Company continues to accelerate its pre-commercial activities and infrastructure build-out to support the anticipated U.S. approval and launch of UGN-101 targeted for 1H 2020. The focus is on building awareness of our RTGel technology and unmet needs in UTUC to support rapid adoption and seamless integration of UGN-101 into the urologist practice following regulatory approval.

A strong team of seven medical science liaisons (MSLs) have been strategically deployed across the U.S. to engage in scientific exchange and clinical support.

The Company launched www.UTUC.com, the first resource designed to address a void in the urology space by educating patients about UTUC and available treatment options.

Business Development:

UroGen recently entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

First Quarter 2019 Financial Results; 2019 Guidance

As of March 31, 2019, cash and cash equivalents totaled $246.7 million. This includes net proceeds of approximately $161.4 million from a public offering of ordinary shares in January 2019.

Research and development expenses for the three months ended March 31, 2019 were $9.7 million, including non-cash share-based compensation expense of $2.3 million.

General and administrative expenses for the three months ended March 31, 2019 were $12.7 million, including non-cash share-based compensation expense of $5.1 million.

The Company reported a net loss of $21.4 million, or basic and diluted net loss per ordinary share of $1.11, for the three months ended March 31, 2019.

The 2019 financial guidance set forth during the Company’s year-end earnings call on February 28th remains the same based on current business goals and anticipated activities.

Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 48486174. An archive of the webcast will be available for two weeks on the Company’s website.

On May 9, 2019 Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology, (or "the Company"), focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported financial results for the three months ended March 31, 2019 (Press release, Verastem, MAY 9, 2019, View Source [SID1234536092]).

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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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"We are now into the second full quarter of the COPIKTRA launch and sales were up approximately 38% compared to the prior quarter," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We have also made substantial progress securing broader reimbursement for our product, with over 92% of targeted health plans now listing and providing reimbursement for COPIKTRA. We continue to receive positive feedback from physicians using COPIKTRA for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies or follicular lymphoma (FL) after at least two prior systemic therapies."

"The commercial team has been diligently working to enhance physician and advocacy group awareness of COPIKTRA, and to overcome certain historical misperceptions concerning the PI3K class. We believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into next year. In parallel, we continue to advance duvelisib in additional lines of therapy, both as a monotherapy and in combination, as well as in additional indications like peripheral T-cell lymphoma (PTCL) for which preliminary data are expected by the end of this year," concluded Mr. Forrester.

Key First Quarter 2019 and Recent Accomplishments:

COPIKTRA (duvelisib)

Launched COPIKTRA in FL – In mid-March 2019, upon completion of the required 120-day waiting period following receipt of accelerated approval from the FDA, the Company launched its physician education and marketing campaign for COPIKTRA for the treatment of patients with FL after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon confirmatory trials, the first of which is expected to start in 2019.
Presented COPIKTRA Data at the 23rd Annual International Congress on Hematologic Malignancies (ICHM) – The Company presented four COPIKTRA abstracts at ICHM 2019, including an abstract highlighting Phase 3 DUO data in patients with relapsed or refractory CLL/SLL who have progressed following two prior lines of the therapy. This is the same indication for which COPIKTRA received approval from the FDA in September 2018. In this analysis, COPIKTRA demonstrated progression-free survival (PFS) of 16.4 months and an ORR of 78%, with a manageable safety profile. The remaining three abstracts featured data from a long-term (>2 years) efficacy and safety analysis, the Phase 3 DUO crossover extension study, and prognostic and immune-related factors associated with response to duvelisib from the Phase 2 DYNAMO study in indolent non-Hodgkin’s lymphoma (iNHL). Collectively, the data presented at ICHM 2019 continue to support the use of COPIKTRA in its approved indications of relapsed or refractory CLL/SLL after at least two prior therapies and FL after at least two prior systemic therapies. PDF copies of all of the ICHM 2019 poster presentations are available here.
Phase 2 DYNAMO Study Results Published in the Journal of Clinical Oncology – In February 2019, results of the Phase 2 DYNAMO study, which evaluated COPIKTRA in patients with indolent non-Hodgkin lymphoma (iNHL) who were refractory to both rituximab and chemotherapy or radioimmunotherapy, was published online in the peer-reviewed Journal of Clinical Oncology. The full manuscript, titled "DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients with Refractory Indolent Non-Hodgkin Lymphoma," (Flinn, et al. DOI: 10.1200/JCO.18.00915) can be accessed at www.ascopubs.org.
Continued Commercialization of COPIKTRA in the United States – Verastem Oncology launched COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, in the United States following FDA approval for the treatment of adult patients with relapsed or refractory CLL/SLL after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.

COPIKTRA contains a BOXED WARNING for fatal and/or serious toxicities including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology has implemented a Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is associated with other adverse reactions which may also require dose reduction, treatment delay or discontinuation of COPIKTRA.

Please see www.COPIKTRAHCP.com/prescribinginformation for full Prescribing Information including BOXED WARNING and Select Important Safety Information provided below.
Corporate and Financial

Chief Commercial Officer Joseph Lobacki to Step Down in 2019 – Joseph Lobacki, Chief Commercial Officer of Verastem Oncology will be stepping down from the Company in 2019 to pursue other professional opportunities, including Board of Director roles. Mr. Lobacki intends to continue in his role until the Company identifies and appoints a successor. During this transition, Brian Stuglik, RPh, a member of the Company’s Board of Directors and the former Chief Marketing Officer of Lilly Oncology, will provide strategic oversight and advisory support for the commercial organization.
Amended Hercules Loan Facility – In April 2019, the Company announced an amendment to its existing Loan and Security Agreement with Hercules Capital, Inc., changing key terms of the agreement, including a lower overall interest rate and an extended principal repayment timeline. The amendment also increases the borrowing limit from $50 million to $75 million in financing.
First Quarter 2019 Financial Results

Net product revenue for the 2019 Quarter was $1.7 million, which reflects the second full quarter of recorded sales for COPIKTRA. The Company did not have any product revenue for the 2018 Quarter as the FDA approved COPIKTRA on September 24, 2018.

Research and development (R&D) expense for the 2019 Quarter was $9.8 million, compared to $10.9 million for the 2018 Quarter. The decrease of $1.1 million, or 11%, was primarily related to a decrease in consulting fees as a result of activities to file a New Drug Application for COPIKTRA in the 2018 Quarter and lower R&D costs associated with the development of COPIKTRA as a result of site closures in the Company’s Phase 3 DUO and Phase 2 DYNAMO studies throughout 2018 and 2019 as patients continue to complete treatment. All of these lower costs were partially offset by an increase in costs related to the Phase 2 PRIMO study for the treatment of patients with relapsed or refractory PTCL.

Selling, general and administrative expense for the 2019 Quarter was $26.0 million, compared to $9.8 million for the 2018 Quarter. The increase of $16.2 million, or 165%, was primarily due to higher personnel and related costs, as well as promotional and consulting costs in support of the launch of COPIKTRA.

Net loss for the three months ended March 31, 2019 (2019 Quarter) was $38.1 million, or $0.52 per share (basic and diluted), as compared to $21.1 million, or $0.41 per share (basic and diluted), for the three months ended March 31, 2018 (2018 Quarter). In addition, net loss includes non-cash stock-based compensation expense of $2.2 million and $1.3 million for the 2019 and 2018 Quarters, respectively.

As of March 31, 2019, Verastem Oncology had cash, cash equivalents and short-term investments of $211.7 million.

Financial Outlook

For 2019, the Company expects net product revenue from sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 7199457.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. In 2018, there were approximately 200,000 patients in the United States affected by CLL/SLL with nearly 20,000 new diagnoses. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. In 2018, this lymphoma subtype accounted for 20 to 30 percent of all NHL cases, with more than 140,000 people in the United States with FL and more than 13,000 newly diagnosed patients. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.