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Constellation Pharmaceuticals Announces Third-Quarter and Nine-Month 2018 Financial Results

On November 8, 2018 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2018 financial results (Press release, Constellation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531184]).

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"We are excited about the progress we have made this year with our clinical programs and our entire epigenetics platform," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "In 2019, we look forward to further progress in our pipeline, as we expect to evaluate proof of concept for both our ProSTAR and MANIFEST clinical trials in mid-2019 as well as initiate clinical development of our second-generation EZH2 inhibitor CPI-0209."

Myovant Provides Corporate Updates and Reports Financial Results for Second Fiscal Quarter Ended September 30, 2018

On November 8, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the second fiscal quarter ended September 30, 2018 (Press release, Myovant Sciences, NOV 8, 2018, http://investors.myovant.com/news-releases/2018/11-08-2018-210604964 [SID1234531182]).

"We continue to make significant progress in advancing our Phase 3 clinical trials and have achieved several important milestones," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We completed patient enrollment in both our Phase 3 LIBERTY 1 trial evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids and our Phase 3 HERO trial evaluating relugolix monotherapy in treating men with advanced prostate cancer. Screening has also been completed for our Phase 3 LIBERTY 2 trial. We remain on track to announce top-line safety and efficacy data for relugolix in 2019 in three distinct indications, each with wholly owned North American and European rights."

Recent Business Highlights and Upcoming Milestones

Relugolix Phase 3 Clinical Programs

Completed enrollment in the Phase 3 LIBERTY 1 trial and completed patient screening for the Phase 3 LIBERTY 2 trial. Both trials are evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids. Top-line safety and efficacy data from the LIBERTY 1 trial are expected in the second quarter of 2019, and data from the LIBERTY 2 trial are expected in the third quarter of 2019, with a New Drug Application (NDA) filing expected in the fourth quarter of 2019.
Continued enrolling patients in the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which are evaluating relugolix in women with pain associated with endometriosis. Top-line results are expected in 2019.
Completed patient enrollment in the pivotal Phase 3 HERO trial, which is evaluating the safety and efficacy of relugolix monotherapy for the treatment of men with advanced prostate cancer. Top-line safety and efficacy data are expected in the fourth quarter of 2019, with a NDA filing expected in early 2020.
MVT-602 Clinical Program

Presented data at the American Society for Reproductive Medicine (ASRM) Annual Congress from a Phase 1 trial of MVT-602, a novel oligopeptide kisspeptin-1 receptor agonist in development as a potential treatment for female infertility in women as part of assisted reproduction.
Completed enrollment in a Phase 2a clinical trial in approximately 70 fertile women undergoing a controlled ovarian stimulation. Top-line results are expected in the first half of 2019.
Corporate

Appointed Kim Sablich, formerly Vice President of Primary Care Marketing in the United States for GlaxoSmithKline (GSK), as Chief Commercial Officer, and Jeff Nornhold, formerly Senior Vice President of Technical Operations for Impax Laboratories (now Amneal Pharmaceuticals, Inc.), as Senior Vice President of Pharmaceutical Operations & Development.
Appointed industry veterans Myrtle Potter, Mark Guinan and Frank Torti, M.D., to the company’s Board of Directors, and Ms. Potter to Chairman of the Board.
Raised aggregate net proceeds of approximately $74.4 million from the issuance and sale of 3,533,399 common shares in an underwritten secondary public equity offering.
Second Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended September 30, 2018, were $53.8 million compared to $24.2 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, as well as additional personnel-related expenses and MVT-602 clinical trial expenses.

General and administrative (G&A) expenses for the quarter ended September 30, 2018, were $10.3 million compared to $6.1 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter ended September 30, 2018, was $1.6 million compared to no interest expense in the comparable prior year period. Interest expense for the quarter consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P. and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended September 30, 2018, was $65.8 million, compared to $29.9 million for the comparable period in 2017. On a per common share basis, net loss was $0.99 and $0.50 for the quarters ended September 30, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs outlined above.

Capital resources: Cash and committed funding totaled $246.3 million at September 30, 2018, consisting of $154.3 million in cash and $92.0 million in remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist. More than 2,150 study participants have received treatment with relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In completed trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones.

In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with pain associated with endometriosis, relugolix is undergoing evaluation in combination with estradiol and norethindrone acetate, a progestin, and as monotherapy. Myovant is studying whether the combination decreases estradiol levels to the range required to treat signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects associated with low estrogen levels, which include bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix monotherapy in men with advanced prostate cancer.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men.

A Phase 2a clinical trial in healthy female volunteers is under way to characterize the dose-response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile women seeking pregnancy.

BioTime Reports Third Quarter 2018 Financial Results and Provides Business Update

On November 8, 2018 BioTime, Inc. (NYSE American:BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported financial and operating results for the third quarter ended September 30, 2018 (Press release, BioTime, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376133 [SID1234531179]). BioTime management will host a conference call and webcast today at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time to provide a business update.

"I am excited to have joined BioTime at a pivotal time in the Company’s development. This past quarter is a great example of how we plan to transform BioTime into a premiere cell therapy company, as we were highly active on the clinical, corporate development, and operational fronts," stated Brian M. Culley, Chief Executive Officer of BioTime. "Our upcoming acquisition of Asterias will create a pipeline of product candidates which supports our objective of turning ambitious plans into treatment reality. Moreover, as evidenced by the planned spin-off of AgeX Therapeutics, we will seek to unlock value from our broad patent platform and invest capital into our core programs. Importantly, our lead program, OpRegen, continues to generate encouraging results in a disease with no currently-approved therapies. Successfully delivering on our stated milestones at each stage of corporate and clinical development and increasing our visibility within the investment and medical communities through strategic and active engagement are key areas of focus for us which will help drive the company’s success."

Recent Highlights

Biotech executive Brian M. Culley appointed as Chief Executive Officer. Mr. Culley brings more than 25 years of experience, spanning diverse operational areas including strategy, finance, licensing, and clinical development. Ms. Culley holds a B.S. in biology from Boston College, a masters in biochemistry from the University of California, Santa Barbara and an M.B.A. from The Johnson School of Business at Cornell University. He has worked as a bench scientist, technology transfer professional, head of business development and most recently served consecutively as the CEO of two publicly-traded biotech companies.
Announced today entry into a merger agreement to acquire Asterias Therapeutics, Inc. (NYSE American:AST) in an all stock transaction. Upon consummation of the transaction and as a result of the merger, BioTime will acquire two clinical-stage cell therapy product candidates addressing significant unmet medical needs in spinal cord injury and immuno-oncology.
Received $43.2 million for approximately one-half of BioTime’s interest in AgeX Therapeutics Inc. ("AgeX") to Juvenescence Ltd., which will help support development of BioTime’s core programs. BioTime received $21.6 million in cash. The remaining $21.6 million was received in the form of a two year promissory note, which is convertible into Juvenescence common stock, upon its IPO, if completed prior to maturity. BioTime and AgeX will continue to collaborate towards the success of both companies in order to maximize the potential of the AgeX programs and provide for enhanced equity value, milestone payments, and royalties owed to BioTime under this agreement.
Encouraging OpRegen Data Presented at 2018 American Academy of Ophthalmology Annual Meeting. Treatment with OpRegen continues to be well tolerated and shows signs of structural improvement in the retina and decreases in drusen density in some patients. Notably, early data from Cohort 4 patients with earlier-stage dry-AMD are promising and indicate structural improvement within the retina, evidence of the continued presence of the transplanted OpRegen cells, and improvements in visual acuity.
Announced November 16, 2018 Record Date and November 28, 2018 Distribution Date for the distribution of the majority of shares of AgeX common stock owned by BioTime on a pro rata basis to eligible BioTime shareholders as of the Record Date. BioTime shareholders will receive one share of AgeX common stock for every 10 Shares of BioTime common stock held as of the Record Date. BioTime shareholders will not have to surrender or exchange BioTime common shares in order to receive AgeX shares.
Third Quarter Financial Results

Cash Position and Marketable Securities: Cash, cash equivalents and marketable securities totaled $21.4 million as of September 30, 2018, compared to $29.2 million as of June 30, 2018. On November 2, 2018, BioTime received the second installment of the $10.8 million receivable from Juvenescence.

Value of Holdings in Public Affiliates: At September 30, 2018, BioTime held common stock in publicly-traded affiliates valued at approximately $65.0 million. This amount was the market value of BioTime’s 21.7 million shares in Asterias Biotherapeutics (NYSE American: AST) and 14.7 million shares in OncoCyte (NYSE American: OCX). If the acquisition of Asterias is completed by BioTime, Asterias will cease to exist as a public entity and there will be no market value to the Asterias shares.

If the planned AgeX distribution is completed on or about November 28, 2018, AgeX common stock will be publicly traded and the AgeX shares BioTime continues to hold after the distribution may be a source of additional liquidity to BioTime, as needed. The AgeX distribution is subject to a number conditions, including the SEC declaring AgeX’s Registration Statement on Form 10 effective.

If the Juvenescence note is converted to Juvenescence common stock prior to its maturity date, the Juvenescence common stock may be a marketable security that BioTime may use to supplement its liquidity, as needed. If the Juvenescence note is not converted, it is payable in cash, plus accrued interest at 7% per year, at maturity.

Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenue was $1.0 million for the third quarter of 2018 compared to $1.7 million in the third quarter of 2017, a decrease of $0.7 million. The decrease was primarily due to a $0.5 million decrease in grant revenues and $0.2 million decrease in subscriptions and advertisement revenues, which are generated by LifeMap Sciences, AgeX’s subsidiary. Beginning on August 30, 2018, subscription and advertising revenues were no longer be included with BioTime due to the deconsolidation of AgeX.

BioTime grant revenues are generated primarily for the development of OpRegen and from a Small Business Innovation Research grant from the National Institutes of Health ("NIH") for its vision restoration program. The decrease in grant revenues for the third quarter of 2018, as compared to the third quarter of 2017, was primarily due to timing of revenues generated as more grant revenues were generated during the first six months of 2018 as compared to 2017, during which grant revenues were earned primarily in the third quarter.

Total revenue was $4.2 million for the nine months ended September 2018 compared to $2.4 million in the same period of the prior year, an increase of $1.8 million. The increase was primarily due to a $1.7 million increase in BioTime grant revenues. Grant revenues generated by Cell Cure from the IIA for the development of OpRegen and the NIH grant amounted to $2.1 million and $0.9 million for the nine months ended September 30, 2018, respectively, compared to grant revenues of $1.2 million in the same period in the prior year generated from the IIA.

Operating Expenses: Total operating expenses for the third quarter of 2018 were $11.3 million, as reported, which is comprised of $9.7 million for BioTime and $1.6 million for AgeX. AgeX was deconsolidated from BioTime on August 30, 2018, and beginning on that date, AgeX’s operating expenses will not be included in BioTime’s operating expenses. Total operating expenses, as adjusted, were $8.8 million for the third quarter of 2018, which is comprised of $7.4 million for BioTime and $1.4 million for AgeX.

The reconciliation between GAAP and non-GAAP operating expenses, by entity, is provided in the financial tables included with this earnings release.

R&D Expenses: Third quarter research and development expenses were $4.9 million compared to $6.6 million for the comparable period in 2017, a decrease of $1.7 million. Research and development expense for the nine months ended September 30, 2018 and 2017 were $17.2 million and $19.3 million, respectively, a decrease of $2.1 million. The decreases of $1.7 million and $2.1 million in total research and development expenses for the three and nine months ended September 30, 2018, as compared to the same periods in the prior year, respectively, were mainly attributable to the following: a decrease of $0.9 million and $0.6 million, respectively, in BioTime related program expenses, primarily related to the completion of the Renevia clinical trial in 2018; decreases of $0.7 million and $0.2 million, respectively, in AgeX related programs, including LifeMap Sciences, due to the deconsolidation of AgeX on August 30, 2018; a decrease of $0.8 million from the nonrecognition of OncoCyte research and development expenses incurred after February 17, 2017 as a result of the deconsolidation of OncoCyte; and a decrease of $0.5 million in LifeMap Solutions expenses resulting from the cessation of its mobile health software development application business in July 2017. The decreases were partially offset by a nonrecurring $0.8 million expense incurred by AgeX on March 23, 2018 with respect to certain acquired in-process research and development.

Beginning on August 30, 2018, BioTime ceased recognizing research and development expenses related to AgeX and its programs due to the deconsolidation of AgeX on that date.

G&A Expenses: Third quarter general and administrative expenses were $6.4 million compared to $4.6 million for the comparable period in 2017, an increase of $1.8 million. This increase was primarily attributable to the following: a $1.4 million increase due to management transition costs, including the hiring of BioTime’s new Chief Executive Officer during September 2018; a $0.5 million increase in legal, accounting and compliance fees for the planned AgeX distribution; $0.2 million increase in license and related fees for patent prosecution and patent fees; and a $0.2 million increase in noncash stock-based compensation expense due to increases in option grants, and restricted stock unit grants made to the CEO. These increases were offset to some extent by a $0.5 million decrease in noncash shareholder expense recorded in the third quarter of 2017 for certain Cell Cure warrants issued in July 2017.

General and administrative expenses for the nine months ended September 30, 2018 were $17.6 million compared to $14.1 million for the nine months ended September 30, 2017, an increase of $3.5 million. This increase was primarily attributable to the following: a $2.3 million increase due to management transition and other compensation related costs noted above; a $1.3 million increase in legal, audit and compliance costs for the planned distribution of AgeX; a $0.7 million increase in license and related fees for patent prosecution and patent fees; a $0.7 million increase in noncash stock based compensation expense; and a $0.4 million increase in AgeX related costs, including LifeMap Sciences, incurred through August 29, 2018, the date before the deconsolidation of AgeX, primarily related to AgeX’s share of legal, audit and compliance costs for the planned distribution of AgeX. These increases were offset by a decrease of $1.4 million in combined general and administrative expenses related to OncoCyte and LifeMap Solutions, and a $0.5 million decrease in noncash shareholder expense recorded in the third quarter of 2017 for certain Cell Cure warrants issued in July 2017.

Beginning on August 30, 2018, BioTime ceased recognizing general and administrative expenses related to AgeX and its subsidiaries due to the deconsolidation of AgeX on that date.

Net Income or loss attributable to BioTime: Third quarter net income attributable to BioTime was $66.7 million, or $0.53 per diluted share, compared to a net income attributable to BioTime of $14.3 million, or $0.12 per diluted share, for the third quarter of 2017. Net loss attributable to BioTime for the nine months ended September 30, 2018 was ($1.0) million, or ($0.01) per share, compared to a net income attributable to BioTime of $52.0 million, or $0.47 per diluted share, for the nine months ended September 30, 2017. Net income or loss attributable to BioTime was primarily driven by noncash gains and losses from the changes in market values of the Asterias and OncoCyte shares held by BioTime, and the gains from deconsolidation of AgeX due to BioTime’s sale of AgeX shares to Juvenescence in 2018, and deconsolidation of OncoCyte in 2017.

Conference Call and Webcast
BioTime will host a conference call and webcast today, at 5:30am PT, 8:30am ET to discuss its third quarter 2018 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and should request the "BioTime Inc. Call". A live webcast of the conference call will be available online in the Investors section of BioTime’s website. A replay of the webcast will be available on BioTime’s website for 30 days and a telephone replay will be available through November 15th, 2018, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and entering conference ID number 8658619.

PROGENICS PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS AND BUSINESS UPDATE

On November 8, 2018 Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) reported financial results and provided a business update for the third quarter of 2018 (Press release, Progenics Pharmaceuticals, NOV 8, 2018, View Source [SID1234531172]).

"The third quarter was marked by multiple successes on the clinical and regulatory front, including the approval and launch of AZEDRA, the first-ever U.S. approved treatment for advanced or metastatic pheochromocytoma and paraganglioma. The broader medical community has recognized the importance of AZEDRA in treating these deadly tumors, and we are pleased with the high level of interest from across the entire spectrum of the healthcare system and well as the rapid addition of AZEDRA to the NCCN guidelines," commented Mark Baker, Chief Executive Officer of Progenics.

Mr. Baker continued, "We are pleased that clinicians and pharmaceutical industry leaders increasingly recognize the value of radiopharmaceuticals to address a range of unmet needs in oncology. Consistent with our strategy to maximize the full value of our PSMA-targeted radio pharmaceutical candidates, we are advancing our prostate cancer pipeline. Following encouraging data from our PyL Phase 2/3 OSPREY study, we are on track to initiate a Phase 3 study this year. In addition, we are moving forward a Phase 2 study for 1095 in patients with metastatic castration-resistant prostate cancer (mCRPC) in early 2019."

Third Quarter and Recent Key Business Highlights

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

AZEDRA Launch Progressing Following FDA Approval in July

In July, Progenics received U.S. Food and Drug Administration (FDA) approval of its New Drug Application for AZEDRA. 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.

AZEDRA Added to NCCN Guidelines and Four CMS-Recognized Drug Compendia

In September 2018, AZEDRA was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors v 3.2018. NCCN Guidelines are widely recognized and used as the standard for clinical policy in oncology by clinicians and payors. Since AZEDRA’s approval by the FDA, it has also been added to four drug compendia: Clinical Pharmacology©; DRUGDEX; Lexi-Drugs; and NCCN. These compendia are recognized by private and public payers, including Centers for Medicare and Medicaid Services (CMS) as authoritative sources to be considered in determining drug reimbursement.

Progenics Announces Third Quarter 2018 Financial Results Page 2

Pivotal trial of AZEDRA published in The Journal of Nuclear Medicine

In October 2018, the study entitled, "Efficacy and Safety of High-Specific-Activity I-131 MIBG Therapy in Patients with Advanced Pheochromocytoma or Paraganglioma," was published in The Journal of Nuclear Medicine. This article reported the complete results of the pivotal study of AZEDRA, which was the largest multicenter, prospective trial to evaluate the safety and efficacy of any therapy in patients with pheochromocytoma and paraganglioma and formed the basis of AZEDRA’s approval by the FDA.

AZEDRA Safety and Tolerability Data to be presented at a Special Interest Session at RSNA

In November, Progenics will present updated safety and tolerability data for High-Specific-Activity MIBG (AZEDRA) at the Special Interest Session: High Impact Clinical Trials the 104th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA).

PSMA-Targeted Prostate Cancer Pipeline

Advancing 1095 Therapeutic into Phase 2 Development

In October 2018, following discussions with the FDA, Progenics announced plans for a Phase 2 study of 1095 in combination with enzalutamide in chemo-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). 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. It is believed that once 1095 binds to the prostate cancer cells, the drug is internalized and the beta radiation kills the tumor cells. Enrollment is expected to begin in early 2019 and PyL, Progenics’ PET/CT imaging agent, will be used to select patients most likely to benefit from 1095 treatment.

Company decides to focus PSMA-Targeted Imaging Agent Efforts on PyL, Not Investing in Additional 1404 Trials

After review of the results of its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent to visualize cancer; and an assessment of the PSMA-targeted imaging agent commercial landscape, the Company has decided to focus its efforts on PyL, its PSMA-targeted PET/CT imaging agent, and will not further invest in 1404.

Phase 3 Study of PyL Imaging Agent to Begin by Year End

In September 2018, the Company announced topline results of its Phase 2/3 OSPREY study evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL, in prostate cancer. The study data highlights the strong positive predictive values of PyL to detect prostate cancer in pelvic lymph nodes and metastatic lesions and supports continued development of PyL. Progenics expects to initiate a Phase 3 study of PyL for the detection of biochemical recurrence of prostate cancer by the end of 2018.

Initiation of Phase 1 Study for PSMA-TTC by Bayer Expected in 2018

Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’ PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.

Progenics Announces Third Quarter 2018 Financial Results Page 3

Digital Technology Portfolio

Artificial Intelligence Imaging Analysis Technology to Use 1404 and PyL Data

Progenics’ imaging analysis technology uses artificial intelligence and machine learning to quantify and automate the reading of PSMA targeted imaging. Data from the company’s pipeline of PSMA-targeted imaging agents (1404 and PyL) is being used to develop deep learning algorithms delivered through compliant medical device software for the automatic detection and quantification of prostate cancer images. The use of AI applications can boost performance, increases objectivity and repeatability, and makes complex but clinically relevant assessments available to physicians in the interpretation of large and complex image data.

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

Third Quarter 2018 RELISTOR Net Sales of $34.5 Million

The third quarter 2018 net sales of RELISTOR, as reported to Progenics by its partner Bausch Health Companies, Inc. (formerly known as Valeant Pharmaceuticals, Inc.), translated to $5.2 million in royalty revenue for Progenics for the quarter.

Third Quarter 2018 Financial Results

Third quarter revenue totaled $5.3 million, up from $2.7 million in the third quarter of 2017, reflecting RELISTOR royalty income of $5.2 million compared to $2.6 million in the corresponding period of 2017.

Third quarter research and development expenses decreased by $2.3 million compared to the corresponding prior year period, resulting primarily from lower external costs associated with the completion of the Phase 2 study for AZEDRA and the Phase 3 trial for 1404. Third quarter selling, general and administrative expenses increased by $1.1 million compared to the corresponding prior year period, primarily attributable to higher costs associated with the commercial launch of AZEDRA. Progenics also recorded a net non-cash charge of $15.2 million in the third quarter 2018, resulting from changes in estimated fair values of intangible assets and contingent consideration liability, primarily related to 1404. For the three months ended September 30, 2018, Progenics recognized interest expense of $1.2 million related to the RELISTOR royalty-backed loan and $1.5 million income tax benefit associated with the non-cash charge recorded as a result of the change in estimated fair value of 1404 intangible assets mentioned above.

Net loss for the third quarter was $24.4 million, or $0.30 per diluted share, compared to net loss of $15.4 million, or $0.22 per diluted share, in the corresponding 2017 period.

Progenics ended the third quarter with cash and cash equivalents of $148.9 million, an increase of $58.2 million compared to cash and cash equivalents as of December 31, 2017. During the quarter, the Company raised net proceeds of $70.0 million in an underwritten public offering of 9.1 million shares of common stock at a public offering price of $8.25 per share and an additional $4.8 million in at-the-market ("ATM") transactions of 0.6 million shares of common stock at an average selling price of $8.36 per share. Progenics intends to use the proceeds to support the launch of AZEDRA, to advance its pipeline and for potential business development opportunities.

Conference Call and Webcast

Progenics will review third quarter financial results in a conference call today at 8:30 a.m. ET. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 6409609. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available 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.

Progenics Announces Third Quarter 2018 Financial Results Page 6

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.

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.

Reference:

AZEDRA prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 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.

Progenics Announces Third Quarter 2018 Financial Results Page 7

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.

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%).

Please see complete Prescribing Information for RELISTOR at www.bauschhealth.com. For more information about RELISTOR, please visit www.RELISTOR.com.

PULSE BIOSCIENCES, INC. ANNOUNCES RECORD DATE, SUBSCRIPTION PRICING,
AND EXPIRATION DATE FOR RIGHTS OFFERING AND EFFECTIVENESS OF ITS
REGISTRATION STATEMENT

On November 8, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported that it has set key dates and pricing structure for its previously announced rights offering of $45,000,000 of its common stock (Press release, Pulse Biosciences, NOV 8, 2018, View Source [SID1234531168]).

Pulse Biosciences intends to issue non-transferable subscription rights to purchase shares of its common stock to common stockholders as of 5:00 p.m. Eastern Time on Monday November 19, 2018 (the "Record Date"). Any person who purchases shares prior to the Record Date will be deemed a holder of record with respect to those shares only if the transaction has settled by the Record Date. The standard settlement cycle in the United States is currently the trade date plus two business days. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer to ensure the settlement of transactions prior to the Record Date.

Following the Record Date, the Company intends to mail to stockholders of record on the Record Date a prospectus and related documents for use in exercising subscription rights. The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on Thursday December 6, 2018 (the "Expiration Date").

Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase up to $45,000,000 of shares of its common stock at a subscription price per share equal to the lesser of (i) $13.33 per share, the closing price on November 7, 2018 (the "Initial Price") or (ii) the volume weighted average price (the "Alternate Price") of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Stockholders wishing to exercise subscription rights must timely pay $13.33 per share, the Initial Price, for the number of shares of common stock they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional shares in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional shares that are not purchased by other stockholders, on a pro rata basis and subject to availability and ownership limitations.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in offering documents. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information and subscription agent for the rights offering, after the Record Date by calling (888) 789-8409 (toll-free) or by emailing [email protected].