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.

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"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.

On November 8, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the third quarter ended September 30, 2018 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, NOV 8, 2018, View Source [SID1234530953]).

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"Recent clinical and corporate achievements support Deciphera’s transition to a late-stage, pre-commercial company," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "Data presented at ESMO (Free ESMO Whitepaper) have bolstered our confidence in DCC-2618’s potential to transform the current treatment paradigm for GIST patients. As we approach the completion of enrollment for our pivotal Phase 3 INVICTUS study in the coming weeks, we look forward to the data readout from that study expected next year. In addition, we remain on track to initiate our Phase 3 INTRIGUE study later this year. We are building our commercial capabilities for DCC-2618 in the United States and are continuing to invest in our clinical-stage pipeline, with the recent initiation of our Phase 1b/2 clinical study of our investigational agent rebastinib in combination with paclitaxel."

Clinical Programs

DCC-2618
At the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October 2018, Deciphera presented updated preliminary Phase 1 clinical study results of DCC-2618 in patients with gastrointestinal stromal tumors (GIST). Highlights from the presentation included:
Preliminary median progression free survival (mPFS) in second- and third-line GIST patients of 42 weeks and 40 weeks, respectively, that the Company believes demonstrates the potential for improved and durable clinical outcomes in patients with less advanced disease.
Updated objective response rates (ORR) and disease control rates (DCR) in second- and third-line GIST patients continue to exceed previously published results of registrational trials for currently approved therapies.
In fourth-line and fourth-line-plus GIST patients, for whom there are currently no approved therapies, the Company believes that the observed mPFS of 24 weeks demonstrates the potential for durable clinical outcomes in patients with advanced disease. Published studies have reported a mPFS of 4 to 6 weeks for similarly heavily pre-treated patients who did not receive an active therapy.
Deciphera expanded the ongoing Phase 1 study to include additional cohorts for patients with: various solid tumors, including melanoma; non-small cell lung cancer; germ cell cancer; penile cancer; soft tissue sarcoma; GIST or other solid tumor patients with renal impairment.
Deciphera will present preclinical data on the effects of the combination of DCC-2618 and MAPK pathway inhibitors on cell death and apoptosis in cellular assays of GIST and mastocytosis in a poster session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13, 2018.
Data in GIST patients from the ongoing Phase 1 study that were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in October 2018 will also be presented at the Annual Meeting of the Connective Tissue Oncology Society (CTOS) on November 15, 2018.
Deciphera previously announced that, following discussions with regulatory authorities in the United States and Europe, it is planning to initiate later this year a randomized, multicenter, open-label, pivotal Phase 3 INTRIGUE study evaluating DCC-2618 compared to sunitinib in second-line GIST patients.
Rebastinib
Deciphera initiated a Phase 1b/2 clinical study of rebastinib, the Company’s small molecule kinase switch control inhibitor of TIE2. In this two-part clinical study, rebastinib will be evaluated for the treatment of patients with advanced or metastatic solid tumors in combination with paclitaxel.
DCC-3014
Deciphera continues to enroll patients in the Phase 1 dose escalation study of DCC-3014, a selective small molecule kinase switch control inhibitor of CSF1R and expects to provide an update on this study later this year.
Corporate Updates

In September 2018, Deciphera appointed Daniel C. Martin as Chief Commercial Officer. Mr. Martin has more than 20 years of commercial experience within the biopharmaceutical industry with extensive background in oncology, including immuno-oncology.
In November 2018, Oliver Rosen, M.D., informed Deciphera that effective November 30, 2018, he would leave his position as the Company’s Chief Medical Officer to pursue another opportunity at an early-stage, private biotechnology company. The Company has commenced a search for his replacement.
"On behalf of the management team and board of directors, I want to thank Oliver for his many contributions to Deciphera over the past four and a half years," said Dr. Taylor. "During his tenure, Oliver was instrumental in developing DCC-2618 from a promising preclinical asset into a robust late-stage clinical program with a pivotal Phase 3 study expected to read out in 2019, a second Phase 3 study that is planned to initiate soon and a series of expansion studies in multiple indications. We wish Oliver all the best in his future endeavors."

"It has been a privilege to be a part of Deciphera’s successful growth since 2014 led by the rapid development of DCC-2618," said Dr. Rosen. "I am proud of the progress the Company has made in translating the promise of its kinase switch control platform into an exciting pipeline of clinical-stage drug candidates designed to provide cancer patients with novel therapies that address unmet medical needs."

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, cash and cash equivalents were $320.9 million, compared to cash and cash equivalents of $196.8 million as of December 31, 2017. This increase was primarily related to proceeds obtained through the Company’s June 2018 underwritten public offering, offset by cash used in operating activities. We expect our current cash and cash equivalents will enable us to fund our operating and capital expenditures and debt service payments into the second half of 2020.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $20.6 million, compared to $9.8 million for the same period in 2017. The increase was primarily due to an increase in spending on the DCC-2618 program of $6.1 million as a result of clinical trial costs related to the pivotal Phase 3 INVICTUS study that began enrollment in January 2018. Clinical trial costs also increased due to start-up activities related to a second Phase 3 INTRIGUE study in second-line GIST, which is expected to be initiated by the end of 2018. In addition, chemistry, manufacturing and controls development and manufacturing costs for the DCC-2618 program increased as a result of process development activities to support anticipated drug requirements for commercialization and the manufacture of registration lots to support the submission of a new drug application. Expenses related to the rebastinib program increased $1.5 million, primarily due to start-up activities related to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which initiated in October 2018. Personnel-related costs increased $2.7 million due to increased headcount in our research and development functions. Personnel-related costs for the third quarters of 2018 and 2017 included non-cash share-based compensation expense of $1.1 million and $0.5 million, respectively.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $5.3 million, compared to $2.4 million for the same period in 2017. The increase was primarily due to an increase in non-cash share-based compensation expense related to additional employee stock options and a higher value of our common stock and to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company. Facility-related and other costs increased due to director and officer insurance costs and higher rent expense related to our new lease. Non-cash share-based compensation was $1.5 million and $0.6 million for the third quarters of 2018 and 2017, respectively.
Net Loss: For the third quarter of 2018, Deciphera reported a net loss of $24.4 million, or $0.65 per share, compared with a net loss of $12.0 million, or $1.04 per share, for the same period in 2017.

On November 8, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported the appointment of Robert Ward to its Board of Directors. Mr. Ward is currently Chairman and Chief Executive Officer of Eloxx Pharmaceuticals (Press release, OncoSec Medical, NOV 8, 2018, View Source [SID1234530999]).

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"It is with great pleasure that we welcome Bob to our Board. His considerable industry experience leading pharmaceutical companies in bringing new therapies to market and deep insight into successful commercialization strategies will be extremely valuable to OncoSec as we continue to advance our TAVO platform," said Avtar Dhillon, Chairman of OncoSec.

Mr. Ward brings to OncoSec over 30 years of experience as a global biopharmaceutical industry leader with experience across the full spectrum of drug development and commercialization. Mr. Ward currently serves as Chairman and Chief Executive Officer of Eloxx Pharmaceuticals. Prior to joining Eloxx, Mr. Ward was President and Chief Executive Officer of Radius Health, Inc., where he helped the company successfully complete its initial public offering and lead the development, approval and launch of the company’s TYMLOS injection. Prior to joining Radius, Mr. Ward was Vice President for Strategy and External Alliances for the New Opportunities iMed of Astra Zeneca. He has held a series of progressive management and executive roles with established companies such as NPS Pharmaceuticals, Schering-Plough (Merck), Pharmacia (Pfizer), Bristol-Myers Squibb and Genentech. Mr. Ward currently serves as a Director of the Massachusetts High Technology Council and had served as a Director of Akari Therapeutics from October 2016 to August 2018.

Mr. Ward received a B.A. in Biology and a B.S. in Physiological Psychology, both from the University of California, Santa Barbara, an M.S. in Management from the New Jersey Institute of Technology and an M.A. in Immunology from the John Hopkins University School of Medicine.

On November 8, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Thursday, November 15, 2018 at 8:30 a.m. ET to report financial results for the third quarter ended September 30, 2018 and to provide a business overview (Press release, Bio-Path Holdings, NOV 8, 2018, View Source [SID1234531031]).

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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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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 8564777. A live audio webcast of the call will also be available on the Events section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On November 8, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Scott Wolchko, President and Chief Executive Officer, will present at two upcoming investor conferences in November (Press release, Fate Therapeutics, NOV 8, 2018, View Source [SID1234531048]):

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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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Jefferies 2018 London Healthcare Conference at 4:40 p.m. UTC on Thursday, November 15, 2018 in London.
Piper Jaffray 30th Annual Healthcare Conference at 12:30 p.m. ET on Tuesday, November 27, 2018 in New York City.
Live webcasts of the presentations will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcasts, an archived replay will be available on the Company’s website.