On August 8, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the second quarter of 2019 (Press release, Cytokinetics, AUG 8, 2019, View Source [SID1234538418]). Net loss for the second quarter was $32.1 million, or $0.56 per share, compared to net loss for the second quarter of 2018 of $27.5 million, or $0.51 per share. Cash, cash equivalents and investments totaled $175.1 million at June 30, 2019.

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"During the second quarter, we made progress across the breadth of our pipeline, with particular emphasis on our investigational medicines for cardiovascular diseases of muscle dysfunction," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Our recently completing enrollment in GALACTIC-HF represents a significant milestone towards potentially bringing forward a novel therapy to address the high mortality and hospitalization rates in patients with heart failure. Additionally, we are pleased with encouraging data arising from the Phase 1 study of CK-274 and look forward to the planned initiation of a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy later this year. Our leadership in muscle biology affords us multiple opportunities to advance our drug candidates as our clinical trials generate clinical evidence to support the promise of potential new therapies."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. In July 2019 we announced the completion of patient enrollment in GALACTIC-HF, having enrolled over 8,200 patients in 35 countries. We expect GALACTIC-HF to continue throughout 2019 and the next planned interim analysis in the first half of 2020.

Continued conduct of METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). Results from the Phase 1 study have been accepted for presentation at the 23rd Annual Heart Failure Society of America (HFSA) Scientific Meeting in Philadelphia in September 2019.

Received feedback from FDA regarding the design of a planned Phase 2 clinical trial of CK-274 and made preparations for the start of that trial which we expect to begin in the fourth quarter of this year.

Presented preclinical data at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) Scientific Sessions in Boston demonstrating that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM and support the therapeutic hypothesis relating to onset of action and reversibility.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Presented results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology 71st Annual Meeting in Philadelphia. FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, the ALSFRS-R total score in patients who received reldesemtiv declined less than patients who received placebo (p = 0.01). The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints.

Continued to analyze results from FORTITUDE-ALS to inform the design of a potential Phase 3 trial and registration program that may begin in 2020.

Concluded a Phase 1 study of reldesemtiv in healthy volunteers designed to assess higher doses and related plasma exposures than were evaluated in the prior Phase 2 study of patients with SMA. We are evaluating the data from the study to inform the design of potential future clinical trials.

Presented data from two preclinical studies of reldesemtiv at the 2019 Annual Cure SMA Conference in Anaheim, CA, showing that the addition of reldesemtiv to treatment with SMN upregulators (nusinersen and SMN-C1, an analogue to risdiplam) significantly increased muscle force in a mouse model of spinal muscular atrophy (SMA).
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ research activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

We are currently in discussions with Astellas regarding amending the terms of our collaboration agreement, including, for reldesemtiv, the level of potential funding and share of commercial returns, as well as which company would be responsible for development and commercialization.

Announced the continuation of our partnership with The ALS Association in the fight against ALS with renewal of Gold Level Sponsorship of the National Walks to Defeat ALS and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people living with ALS in the San Francisco Bay Area.
Financials

Revenues for the three and six months ended June 30, 2019 were $7.1 million and $15.6 million, respectively, compared to $6.2 million and $11.5 million for the corresponding periods in 2018. The increase in revenues for the three and six month ended June 30, 2019 was due primarily to reimbursements for METEORIC-HF offset by no license revenue in 2019. License revenues in the second quarter and first half of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscular atrophy completed in 2018.

Research and development expenses for the three and six months ended June 30, 2019 increased to $24.0 million and $47.6 million, respectively compared to $21.6 million and $43.7 million for the same periods in 2018, respectively due to increased spending related to METEORIC-HF and the development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017.

General and administrative expenses for the three and six months ended June 30, 2019 increased to $9.8 million and $19.3 million from $8.0 million and $17.3 million in 2018 due primarily to an increase in outside legal counsel and personnel related costs.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 1778276.

An archived replay of the webcast will be available via Cytokinetics’ website until August 15, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 1778276 from August 8, 2019 at 7:30 PM Eastern Time until August 15, 2019.

On August 8, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the second quarter ended June 30, 2019 (Press release, Checkpoint Therapeutics, AUG 8, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-second-quarter-2019-financial-results-and-recent-corporate-highlights/ [SID1234538417]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During the second quarter, we continued to advance our lead clinical programs toward key interim data readouts expected in the second half of 2019. We look forward to reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor, before year-end, with the goal of commencing a Phase 3 clinical trial in first-line EGFR mutation-positive non-small cell lung cancer ("NSCLC") in 2020. In May, we announced positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, showing anti-tumor activity across multiple advanced cancers. The initial data are encouraging and potentially differentiate cosibelimab from other drugs in this class as a result of its dual mechanism of action through engaging both T-cells and NK cells. We intend to announce updated clinical data on cosibelimab later this year."

Financial Results:

Cash Position: As of June 30, 2019, Checkpoint’s cash and cash equivalents totaled $13.2 million. On a non-GAAP basis, pro-forma cash and cash equivalents as of June 30, 2019 (excluding third quarter 2019 operations) totaled approximately $16.2 million, after giving effect to approximately $3.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement (the "ATM") during the third quarter of 2019. Checkpoint believes that its cash and cash equivalents and projected licensing revenue, along with the additional capital raised in the third quarter of 2019, will be sufficient to fund its anticipated operating cash requirements for at least 12 months.
R&D Expenses: Research and development expenses for the second quarter of 2019 were $4.1 million, compared to $5.5 million for the second quarter of 2018, a decrease of $1.4 million. Research and development expenses for the second quarter of 2019 included $0.2 million of non-cash stock expenses, compared to a credit of $0.4 million in stock compensation expense for the second quarter of 2018. The Company expects that, for the balance of 2019, research and development expenses will continue to remain lower than the comparable periods in 2018.
G&A Expenses: General and administrative expenses for the second quarter of 2019 were $1.8 million, compared to $1.4 million for the second quarter of 2018, an increase of $0.4 million. General and administrative expenses for the second quarter of 2019 included $0.7 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2018.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2019 was $4.8 million, or $0.15 per share, compared to a net loss of $6.6 million, or $0.23 per share, for the second quarter of 2018. The net loss for the second quarter of 2019 included $0.9 million of non-cash stock expenses, compared to $0.1 million for the second quarter of 2018.
Recent Corporate Highlights:

In May 2019, Checkpoint announced positive interim safety and efficacy data from its ongoing multicenter Phase 1 clinical trial of cosibelimab. Cosibelimab is a high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potentially enhanced efficacy in certain tumor types. Cosibelimab appeared to be safe and well-tolerated with no dose-limiting toxicities. Objective responses and target lesion reductions were observed across diverse tumor types, particularly in NSCLC and cutaneous squamous cell carcinoma.
In July 2019, Checkpoint announced that it was added to the Russell 2000 Index.

On August 8, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the second quarter ended June 30, 2019. As of June 30, 2019, cash equivalents and investments totaled $153.2 million (Press release, Calithera Biosciences, AUG 8, 2019, View Source [SID1234538415]).

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"In the second quarter, we achieved clinical proof of concept for our glutaminase inhibitor telaglenastat, with positive topline results of the randomized phase 2 ENTRATA study," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "After completing a secondary offering in the quarter, we are well positioned to execute on our strategy and advance our pipeline forward. In the second half of the year, we look forward to completing enrollment in our registrational CANTATA trial evaluating telaglenastat for the treatment of patients with renal cell carcinoma, as well as presenting data from our arginase inhibitor program INCB001158."

Second Quarter 2019 and Recent Highlights

Achieved positive topline results in randomized Phase 2 ENTRATA study of telaglenastat (CB-839) with everolimus in renal cell carcinoma. The ENTRATA trial (NCT03163667) was a Phase 2 randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA was progression-free survival (PFS). The combination doubled the median PFS in heavily pretreated patients with advanced RCC. Telaglenastat, when added to everolimus, doubled the median PFS to 3.8 months as compared to 1.9 months for everolimus alone and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). The primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of p£0.2 one-sided. The secondary endpoint of overall survival is not yet mature.

Initiated Phase 1/2 clinical trial of telaglenastat in combination with palbociclib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s CDK4/6 inhibitor palbociclib, also known as Ibrance. The study will evaluate the safety and anti-tumor activity of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and KRAS-mutated non-small cell lung cancer (NSCLC).

Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 are expected to be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September.

Presented new preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera anticipates that CB-708 will enter clinical trials in the second half of 2019.

Completed public offering of common stock. In June 2019, Calithera completed an underwritten public offering of common stock. Gross proceeds from the offering, before underwriting discounts and commissions and offering expenses, were $57.5 million.

Selected Second Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $153.2 million at June 30, 2019.

Research and development expenses were $20.9 million for the three months ended June 30, 2019, compared with $17.3 million for the same period in the prior year. The increase of $3.6 million was primarily due to a $1.5 million increase in the telaglenastat program, including for the CANTATA trial, an increase of $1.5 million in the INCB001158 program, and an increase of $0.7 million in the CB-280 program, partially offset by a decrease of $0.1 million for investment in our early stage research programs.

General and administrative expenses were $4.0 million for the three months ended June 30, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.5 million was related to higher professional services costs.

Net loss for the three months ended June 30, 2019 was $24.2 million, or $0.58 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, August 8 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 9239839. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 8, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, reported financial and operating results for the second quarter ended June 30, 2019 (Press release, BioTime, AUG 8, 2019, View Source [SID1234538414]). BioTime management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2019 financial results and to provide a business update.

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"Over the past several quarters, BioTime has completed several transactions to simplify our corporate structure and highlight our cell therapy programs as our top priority. Acquiring Asterias, distributing AgeX, reducing our OncoCyte ownership, hiring a new management team, reducing overhead and headcount, and relocating clinical operations for our OpRegen program to the U.S. are all constructive components of a larger vision we have to become a premier cell therapy company," stated Brian M. Culley, Chief Executive Officer of BioTime. "As a result, we are changing our name to reflect our mission and bring attention to our leadership position in the administration of differentiated human cells to treat serious medical conditions such as dry-AMD, spinal cord injuries, and cancer."

Recent Highlights

●Announced dosing of the first patient with the Orbit Subretinal Delivery System (Orbit SDS) and with the new Thaw-and-Inject formulation of OpRegen, its retinal pigment epithelium (RPE) transplant therapy, in the Company’s ongoing Phase I/IIa clinical study for the treatment of dry age-related macular degeneration (dry-AMD), a leading cause of adult blindness in the developed world.

●Announced the planned launch of its new corporate brand and identity as well as a change in corporate name to Lineage Cell Therapeutics, Inc., reflecting its commitment to becoming an innovative, leading cell therapy company and highlighting its extensive cell therapy platform. In conjunction with the name change, the Company’s ticker symbol will change to "LCTX" on August 12, 2019. The Company also will be relocating its corporate headquarters to Carlsbad, California, effective August 12, 2019, a move which will provide proximity to world-leading academic centers, public and private cell therapy peers, and is expected to offer more centralized decision-making, cost-savings, and access to an extensive network of experienced staff.

●Awarded a new research & development grant for 2019 of up to 9 million Israeli New Shekels (approximately $2.5 million) from the Israel Innovation Authority. The grant provides funding for the continued development of OpRegen and to date, the IIA has provided annual grants totaling approximately $16 million for the development of the OpRegen program.

●Converted approximately 15% of our investment in OncoCyte Corporation into cash to support our operations with the sale of 2,250,000 shares of OncoCyte common stock for gross proceeds totaling $4,500,000. BioTime continues to own approximately 23.9% or 12.4 million shares of OncoCyte’s outstanding common stock. Based on the closing price of OncoCyte’s common stock on August 6, 2019, the value of our remaining OncoCyte shares is approximately $21.7 million.

●The ongoing transfer of assets acquired in the Asterias merger to BioTime’s existing GMP manufacturing facility in Jerusalem in preparation for the hand off of Asterias’s Fremont facility to Novo Nordisk in the third quarter of 2019. These actions are expected to lead to significant cost savings via headcount and facility reductions, as well as support BioTime’s innovative and diversified clinical-stage pipeline.

Current Plans for 2019

●Complete patient enrollment in the United States with the Orbit SDS in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD.
●Present new OpRegen data from the ongoing Phase I/IIa clinical study for the treatment of dry-AMD at the 2019 American Academy of Ophthalmology Annual Meeting in October (AAO 2019).
●Continue to tech transfer and advance the OPC1 program by introducing improvements to the manufacturing process.
●Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.
●Announce decision on BioTime’s CE Mark application for Renevia, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures.
●Evaluate the development of OPC1 as a candidate for the potential treatment of multiple sclerosis (MS) and ischemic stroke through ongoing research collaborations with major universities.
●Launch new corporate brand, website and social media presence.

Balance Sheet Highlights

Cash, cash equivalents and marketable securities totaled $16.7 million as of June 30, 2019. BioTime sold 2,250,000 shares of OncoCyte’s common stock on July 2, 2019 for gross proceeds of $4.5 million. BioTime also sold 647,397 shares of Hadasit Bio-Holdings Ltd. common stock in July 2019 for gross proceeds of $1.2 million.

BioTime’s investment in OncoCyte was valued at $36.5 million as of June 30, 2019. As of August 6, 2019, BioTime’s remaining investment in OncoCyte was valued at $21.7 million, under the equity method of accounting, based on the closing stock price of OncoCyte as of such date.

BioTime’s promissory note due from Juvenescence Limited had an outstanding balance (principal plus accrued interest) of $22.9 million as of June 30, 2019. Unless earlier converted into Juvenescence ordinary shares, the promissory note is payable in cash, plus accrued interest at 7% per year, at maturity in August 2020. If Juvenescence completes an initial public offering (IPO) resulting in gross proceeds of not less than $50.0 million, the promissory note automatically converts into the Juvenescence securities issued in the IPO based on the per-share price to the public in the IPO, subject to an upward adjustment in the number of shares that would be issued to BioTime upon such conversion if the 20-day volume-weighted average trading price of one share of common stock of AgeX Therapeutics, Inc. (AgeX) before the IPO is priced above $3.00. If the promissory note is converted, the Juvenescence ordinary shares will be a marketable security that BioTime may use to supplement its liquidity, as needed and as market conditions allow.

In summary, as of June 30, 2019, the value of the Company’s cash, marketable securities, equity holdings in OncoCyte, and the balance of a promissory note due to it in August 2020 were in excess of $76.0 million.

Second Quarter Operating Results

Note regarding AgeX: On August 30, 2018, BioTime deconsolidated AgeX from its consolidated financial statements due to the sale by BioTime of 14,400,000 shares of AgeX common stock to Juvenescence and the related decrease of BioTime’s ownership position in AgeX from 80.4% to 40.2%. Accordingly, BioTime ceased recognizing revenue and expenses related to AgeX and its programs on such date.

Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenues for the three months ended June 30, 2019 were $0.8 million, a decrease of $1.8 million as compared to the same period in 2018. The decrease was primarily related to a $1.4 million decrease in grant revenues, and a $0.3 million decrease in subscriptions and advertisement revenues attributable to the deconsolidation of AgeX.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses, as reported, for the three months ended June 30, 2019 were $11.5 million, a decrease of $0.1 million as compared to the same period in 2018. Total operating expenses, as adjusted, for the three months ended June 30, 2019, were $9.0 million, a decrease of $0.4 million as compared to the same period in 2018.

The reconciliation between operating expenses determined in accordance with accounting principles generally accepted in the United States (GAAP) and operating expenses, as adjusted, a non-GAAP measure, is provided in the financial tables included at the end of this press release.

R&D Expenses: R&D expenses for the three months ended June 30, 2019 were $5.2 million, a decrease of $1.1 million as compared to the same period in 2018. The decrease was primarily related to a $1.4 million decrease from the AgeX deconsolidation and the absence of AgeX R&D expenses incurred after August 30, 2018, offset by a net increase of $0.3 million in BioTime programs primarily related to: (1) an increase of $1.7 million in OPC1 and VAC2 expenses (these programs were acquired in the Asterias merger) offset by (2) decreases of $1.4 million in Renevia, HyStem and PureStem related expenses.

G&A Expenses: G&A expenses for the three months ended June 30, 2019 were $6.3 million, an increase of $1.0 million as compared to the same period in 2018. The increase was primarily attributable to a $1.9 million increase in severance, legal, accounting and other expenses related to the Asterias merger which was offset by a $1.1 million decrease in AgeX related G&A expenses.

Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended June 30, 2019 reflected other expense, net of ($20.5) million, compared to other income, net of $4.5 million for the same period in 2018. The variance was primarily related to changes in the value of equity investments in OncoCyte and Asterias for the applicable periods.

Net income/(loss) attributable to BioTime: The net income/(loss) attributable to BioTime for the three months ended June 30, 2019 was a net loss of ($30.0) million, or ($0.20) per share (basic and diluted), compared to a net loss attributable to BioTime of ($4.2) million, or ($0.03) per share (basic and diluted), for the same period in 2018.

In line with previous estimates, BioTime expects to spend $14 million to $15 million in the second half of 2019. BioTime anticipates that cash spend in 2020 will range from $24 million to $28 million, a reduction from 2019 spending levels of $32 million to $34 million due to corporate simplification and cost savings initiatives implemented in 2019, and a significant reduction from 2018 spending levels of $43 million for BioTime and Asterias combined.

Conference Call and Webcast

BioTime will host a conference call and webcast today, at 1:30pm PT/4:30pm ET to discuss its second quarter 2019 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 Canada 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 August 15th, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 8783397.

On August 8, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones, and financial results for the second quarter and first half of 2019 (Press release, BeiGene, AUG 8, 2019, View Source [SID1234538413]).

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"This quarter, our team continued to deliver across all functions, with the completion of enrollment in five Phase 3 or pivotal trials and the initiation of three new Phase 3 trials in oncology indications where we expect to have a profound impact on people fighting both hematologic and solid tumors. We believe that we are well-positioned to continue running our late-stage trials, including those for tislelizumab, for which we re-acquired full global rights from Celgene in advance of the closing of its pending acquisition by Bristol-Myers Squibb," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "We are progressing well with our U.S. and China product launch preparations, including our commercial and manufacturing build-outs, and we expect the remainder of 2019 and 2020 to be transformative for BeiGene, with readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to planned commercial launches of two of our internally developed products."
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Completed enrollment in the global Phase 3 SEQUOIA trial (NCT03336333) comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);

Achieved first patient dosing in a Phase 1b trial (NCT02914938) conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;

Presented data at the 15th International Conference on Malignant Lymphoma (ICML), including:
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Clinical data from the pivotal Phase 2 trial (NCT03206918) in China in patients with relapsed/refractory (R/R) CLL or SLL;
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Updated data from the pivotal Phase 2 trial (NCT03206970) in China in patients with R/R mantle cell lymphoma (MCL);
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Updated data from the global Phase 1/2 trial (NCT02343120) in patients with different subtypes of B-cell malignancies, including MCL;
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Updated data from the Phase 1b combination trial (NCT02569476) with GAZYVA (obinutuzumab) in patients with R/R or TN CLL or SLL, and patients with R/R follicular lymphoma (FL).

Presented data at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper), including:
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Clinical data from the nonrandomized cohort in patients with MYD88wt Waldenström’s Macroglobulinemia (WM) from the Phase 3 ASPEN trial (NCT03053440). The randomized cohort of the study, in patients with MYD88mut WM, is ongoing;
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Updated results from the ongoing Phase 1 trial (NCT02343120) of patients with WM;
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Pooled safety data from six ongoing monotherapy studies in patients with B-cell malignancies; and

Published in Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), an article on the Phase 1 trial of zanubrutinib in R/R B-cell malignancies, including CLL/SLL.
Expected Milestones for Zanubrutinib

Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020. The Company expects manufacturing inspections to occur after the completion of the technical reviews. In addition, non-clinical and chemistry, manufacturing and controls (CMC) supplemental information was requested and has been provided;

File an initial New Drug Application (NDA) in the U.S. in 2019 or early 2020;

File a supplemental new drug application (sNDA) in China for WM in 2019;

Announce top-line results from the Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with WM in 2019;

Announce top-line interim analysis from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as 2020; and

Initiate a global Phase 3 clinical trial (NCT04002297) comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated MCL who are ineligible for stem cell transplant in 2019.
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Filed an sNDA in China for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC); the sNDA has been granted priority review status from the China National Medical Products Administration (NMPA);

Regained full global rights from Celgene in advance of its pending acquisition by Bristol-Myers Squibb, and received a payment of $150 million in connection with the termination;

Completed enrollment in the Phase 3 trials in China of tislelizumab combined with chemotherapy in the front-line setting for patients with advanced squamous (NCT03594747) and non-squamous (NCT03663205) non-small cell lung cancer (NSCLC);

Initiated the following trials:
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A Phase 3 randomized trial (NCT04005716) in China of platinum plus etoposide with or without tislelizumab in patients with untreated extensive-stage small cell lung cancer (SCLC);
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A Phase 3 randomized trial (NCT03967977) in China of tislelizumab in combination with chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic UC; and
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A Phase 3 randomized trial (NCT03957590) in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized esophageal squamous cell carcinoma (ESCC).

Presented updated clinical results from the pivotal Phase 2 trial (NCT03209973) in China in patients with R/R classical Hodgkin lymphoma (cHL) at EHA (Free EHA Whitepaper); and

Presented preliminary Phase 2 results from the Phase 1/2 trial (NCT03924986) in China in patients with nasopharyngeal cancer (NPC) at ASCO (Free ASCO Whitepaper).
Expected Milestones for Tislelizumab

Receive NDA approval in China for treatment of patients with R/R cHL in 2019;

Announce top-line results from the global Phase 2 trial (NCT03419897) in second- or third-line patients with hepatocellular carcinoma (HCC) in 2019 or early 2020 and have regulatory discussions;

Announce top-line results from the Phase 3 trial (NCT03594747) in first-line squamous NSCLC in China in 2019 or 2020;

Announce top-line results from the Phase 3 trial (NCT03663205) in first-line non-squamous NSCLC in China in 2020; and

Complete enrollment in the global first-line Phase 3 trial (NCT03412773) in HCC in 2019 and the global portion of the second-line Phase 3 trial (NCT03358875) in NSCLC in 2019 or early 2020.
Pamiparib, an investigational small molecule PARP inhibitor

Completed enrollment in the Phase 3 randomized trial in China (NCT03519230) of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer;

Completed enrollment in the pivotal Phase 2 trial in China (NCT03333915) in third-line and above patients with ovarian cancer with germ-line BRCA mutation; and

Published in The Lancet Oncology an article on the Phase 1A/B trial of pamiparib in combination with tislelizumab in patients with advanced solid tumors.
Expected Milestones for Pamiparib

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in 2020; and

Announce top-line results from the Phase 3 trial in China of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer in 2020.
Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Initiated a Phase 1/2 trial (NCT03941873) in China of sitravatinib in combination with tislelizumab in patients with unresectable locally advanced or metastatic HCC or gastroesophageal junction cancer.
BGB-A1217, an investigational TIGIT monoclonal antibody discovered by BeiGene scientists
Expected Milestones for BGB-A1217

Initiate patient enrollment in a Phase 1a/1b trial in China and Australia investigating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors in 2019.
Manufacturing Facilities

Completed equipment installation and systems qualification of the Company’s biologics manufacturing facility in Guangzhou, China. We expect manufacturing and validation of tislelizumab drug substance to begin later this year.
Commercial Product Portfolio

Generated $58.14 million in product revenue in the three months ended June 30, 2019, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents an 85.0% increase compared to the same period in 2018; and

Announced that the China National Medical Products Administration (NMPA, formerly known as CFDA) accepted the supplemental import drug application for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in combination with gemcitabine, as a potential first-line treatment of patients with metastatic adenocarcinoma of the pancreas (mPC).
Corporate Developments

Received approval from the Stock Exchange of Hong Kong Limited (HKEX) to transition into a general listing under Rule 8.05(3) by meeting its specified revenue and market capitalization thresholds. As a result of the approval, the "B" marker was removed from the Company’s stock symbol in the HKEX, and the Company’s ordinary shares may become eligible for listing in the Hang Seng indices;

Along with SpringWorks Therapeutics, announced the formation of MapKure, LLC to develop BGB-3245, an investigational, selective next-generation RAF kinase inhibitor discovered by BeiGene scientists;

Appointed Qingyi "Anita" Wu as Chief Commercial Officer, Greater China. Prior to joining BeiGene, Anita served as General Manager of the Specialty Care business unit at Sanofi China; and

Appointed Yan "Lily" Liu as Vice President, Head of Marketing, Greater China. Lily was most recently Vice President, Head of the Specialty Care business unit at Takeda China.

Second Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.56 billion as of June 30, 2019, compared to $1.64 billion as of March 31, 2019 and $1.81 billion as of December 31, 2018.

The decrease of $76.07 million in the second quarter of 2019 was primarily due to $46.10 million of cash used in operating activities, $21.45 million for investments in property, plant and equipment, and $20 million for an upfront payment related to the BioAtla collaboration agreement.
Revenue for the quarter ended June 30, 2019 was $243.35 million, compared to $52.80 million in the same period in 2018. The increase is primarily attributable to the $150 million payment received in connection with the termination of the tislelizumab collaboration agreement with Celgene, the recognition of previously deferred revenue from the collaboration as well as increased product revenue from sales of the in-licensed products from Celgene in China.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $58.14 million for the second quarter ended June 30, 2019, compared to $31.43 million for the same period in 2018.

Collaboration revenue totaled $185.20 million for the second quarter ended June 30, 2019, compared to $21.38 million for the same period in 2018. The increase is due primarily to the $150 million payment in connection with the termination of our tislelizumab collaboration agreement with Celgene, as well as the recognition of previously deferred revenue from the collaboration.
Expenses for the second quarter ended June 30, 2016 were $329.18 million, compared to $215.85 million in the same period in 2018.

Cost of sales for the second quarter ended June 30, 2019 were $17.84 million, compared to $6.26 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the second quarter ended June 30, 2019 were $228.76 million, compared to $164.25 million in the same period in 2018. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, and manufacturing costs related to pre-commercial activities and supply. Additionally, we expensed $20.0 million for the upfront payment related to the BioAtla collaboration agreement. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $18.15 million for the second quarter ended June 30, 2019, compared to $10.72 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the second quarter ended June 30, 2019 were $82.25 million, compared to $45.16 million in the same period in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $14.45 million for the second quarter ended June 30, 2019, compared to $7.92 million for the same period in 2018, due to increased headcount.

Net Loss for the second quarter ended June 30, 2019 was $85.57 million, or $0.11 per share, or $1.43 per American Depositary Share (ADS), compared to $156.89 million, or $0.22 per share, or $2.92 per ADS in the same period in 2018.

[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd., which totaled $84.49 million as of June 30, 2019, and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility.
[2] The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.