On November 12, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the third quarter ended September 30, 2019, and provided an update on its programs and progress (Press release, Synlogic, NOV 12, 2019, View Source [SID1234550963]).

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"We are making good progress towards our goal of evaluating the breadth of therapeutic applications of our Synthetic Biotic platform. Notably, the recent initiation of the first clinical trial of a Synthetic Biotic medicine for the treatment of cancer represents a significant step for Synlogic," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "We also continue to advance our SYNB1618 program for the treatment of phenylketonuria in an ongoing bridging study to evaluate the tolerability and activity of a solid oral formulation, and we look forward to sharing those data and our plans for the next steps in this program."

Recent Highlights
Pipeline

Clearance of Investigational New Drug (IND) application and initiation of SYNB1891 immuno-oncology (IO) clinical study. Synlogic has initiated a Phase 1 open-label, multicenter, dose escalation trial of its STING-agonist producing bacterial strain, SYNB1891, for the treatment of refractory solid tumors. The study’s primary objectives are to evaluate safety and tolerability of escalating doses of intratumorally administered SYNB1891 as a monotherapy. Once a maximum tolerated dose is established, patients will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, Atezolizumab, to establish a recommended Phase 2 dose for the combination regimen. Synlogic expects to have data from the monotherapy arm of the study in 2020.
Presentation of positive data from Phase 1/2a Study of SYNB1618 in patients with phenylketonuria (PKU) as well as modeling work to estimate target dosing of SYNB1618. In September, clinical data from a randomized, double-blind, placebo-controlled Phase 1/2a study of SYNB1618, which is being developed for the treatment of PKU were presented at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) by Jerry Vockley, M.D. Ph.D., Professor of Pediatrics and Chief of Medical Genetics, University of Pittsburgh, and a principal investigator on the trial. The study’s primary objective was to evaluate safety and tolerability and to measure biomarkers of phenylalanine-consuming activity of multiple ascending doses of a liquid formulation of SYNB1618 in healthy volunteers and a single dose level in PKU patient cohorts. SYNB1618 was well tolerated in healthy volunteers and patients with PKU and the data demonstrated equivalent phenylalanine-consumption.
Initiation of bridging study of a solid oral formulation of SYNB1618 in healthy volunteers to establish maximum tolerated dose (MTD) for efficacy study in patients with PKU. Based on data from its Phase 1/2a study of a liquid formulation of SYNB1618, Synlogic initiated a bridging study in healthy volunteers of a new solid oral formulation to establish an MTD that would potentially enable at least a 30% lowering of blood Phe levels in PKU patients based on the company’s modeling data. With supporting data from the bridging study, Synlogic expects to advance SYNB1618 into an efficacy study in patients in the first half of 2020.
Corporate

Key appointments to Synlogic’s leadership and research and development teams
Richard Riese, M.D. Ph.D., chief medical officer, joined Synlogic in September and has assumed responsibilities for all clinical and regulatory functions from current president and CEO, Aoife Brennan.
Gregg Beloff, interim chief financial officer, was appointed in October 2019. Mr. Beloff, who has more than 20 years of experience in the life sciences industry, brings significant expertise in operational management, strategic planning, corporate and business development, fundraising and mergers and acquisitions.
Third Quarter 2019 Financial Results
As of September 30, 2019, Synlogic had cash, cash equivalents, and short- and long-term investments of $138.7 million. The Company anticipates that, based on its current operating plan, its existing cash and cash equivalents will fund company operations through 2021.

For the three months ended September 30, 2019, Synlogic reported a consolidated net loss of $13.3 million, or $0.39 per share, compared to a consolidated net loss of $10.7 million, or $0.43 per share, for the corresponding period in 2018.

Research and development expenses were $10.6 million for the three months ended September 30, 2019 compared to $9.9 million for the corresponding period in 2018. The increase was primarily due to increased clinical development costs for our SYNB1618 program.

General and administrative expenses for the three months ended September 30, 2019 were $3.9 million compared to $3.4 million for the corresponding period in 2018.

Revenues were $0.3 million for the three months ended September 30, 2019, compared to $1.8 million for the corresponding period in 2018. The revenue for both periods is associated with Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease. The decrease in revenue was primarily the result of the achievement of a $2.0 million milestone under a September 2018 amendment to the AbbVie agreement of which $1.8 million was recognized in revenue in the quarter ended September 30, 2018.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 5:00 p.m. ET today, Tuesday, November 12, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 3889667. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On November 12, 2019 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the third quarter ended September 30, 2019 and provided an update on its corporate activities and product pipeline (Press release, Crinetics Pharmaceuticals, NOV 12, 2019, View Source [SID1234550962]).

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"Crinetics has continued to make significant strides in the development of new therapeutics to treat patients suffering from rare endocrine diseases and endocrine-related tumors," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Our ACROBAT clinical studies for patients with acromegaly are advancing as is our Phase 1 study for CRN01941 aimed at neuroendocrine tumors. Furthermore, we are excited with the progress we have made to develop novel therapies for patients suffering from Cushing’s disease and hyperinsulinism as we continue to steer these programs towards clinical development."

Third Quarter and Subsequent Highlights

Received final award of SBIR grant from NIH for congenital hyperinsulinism. In July 2019, Crinetics announced that it would receive up to approximately $0.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) of the National Institutes of Health (NIH). The funds are being used to support the ongoing research and development of Crinetics’ nonpeptide somatostatin agonists for congenital hyperinsulinemias (CHI).

Expanded board of directors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience having spent her career in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Third Quarter 2019 Financial Results

Research and development expenses were $11.8 million and $29.4 million for the three and nine months ended September 30, 2019, respectively, compared to $6.9 million and $16.8 million for the same periods in 2018. The increases were primarily attributable to development and manufacturing activities for CRN00808 and CRN01941 as well as the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $3.9 million and $10.1 million for the three and nine months ended September 30, 2019, compared to $1.7 million and $4.1 million for the same periods in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended September 30, 2019 was $14.4 million, compared to a net loss of $7.6 million for the same period in 2018. For the nine months ended September 30, 2019, the company’s net loss was $35.9 million compared to a net loss of $18.6 million for the nine months ended September 30, 2018.

Unrestricted cash, cash equivalents and investments totaled $131.7 million as of September 30, 2019, compared to $145.0 million as of June 30, 2019 and $163.9 million as of December 31, 2018. Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan at least through the first half of 2021.

As of October 31, 2019, the company had 24,222,296 common shares outstanding.

On November 12, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported that management will present at the following conferences (Press release, Aclaris Therapeutics, NOV 12, 2019, View Source [SID1234550960]):

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Dr. Neal Walker, President and Chief Executive Officer, together with members from the Company’s R&D team, will present a company overview at SVB Leerink’s 13th Annual POLARxPRESS Bus Tour in New York, New York on Thursday, November 21, 2019. The R&D team will include:
Joseph Monahan, Ph.D. – EVP R&D (Head of Discovery)
Walter Smith – SVP, R&D
Paul Changelian, Ph.D. – VP, Biology
Jon Jacobsen, Ph.D. – VP, Chemistry
Dr. David Gordon – Chief Medical Officer

Dr. Walker will also present a company overview at the Evercore ISI 2nd Annual HealthCONx Conference on Wednesday, December 4, 2019 at 3:05 PM ET at the Four Seasons Hotel in Boston, Massachusetts. A live audio webcast of the presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events’ section. An archived version of the presentation will be available for 30 days.

On November 12, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported financial results for the third quarter ended September 30, 2019 (Press release, Tetraphase, NOV 12, 2019, View Source [SID1234550959]).

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"XERAVA has now been on the market for just over a year, and during that time we have made significant progress, particularly in the third quarter, with 30% carton growth over last quarter, leading to a 23% increase in net XERAVA revenue compared with the previous quarter," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "We are squarely focused on continuing to increase formulary uptake and pull-through, as we believe XERAVA is a critically important new addition to the hospital antibiotic armamentarium, and that increased formulary uptake and pull through will result in increased sales. With our recent equity offering and payoff of debt, we are now in a stronger financial position to execute on these goals."

Third Quarter and Recent Highlights

Continued to Progress Launch of XERAVA in U.S. Hospitals
The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date. Tetraphase’s salesforce is now focusing on bringing XERAVA to both Tier 1 as well as Tier 2 institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be very strong with the reorder rates as high as 57% for all accounts and approximately 70% within the tier 1 account segment. XERAVA is available at more than 1,000 accounts and approximately 154 formulary reviews are pending or planned to take place by the end of the fourth quarter of 2019.
Completed $7M Equity Financing (Net of Fees and Expenses)
In November 2019, the Company completed a registered direct offering with a healthcare-focused institutional investor for the purchase of (i) 300,000 shares of common stock and accompanying warrants to purchase an aggregate of 300,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 1,830,493 shares of common stock and accompanying warrants to purchase an aggregate of 1,830,493 shares of common stock. The net proceeds to the Company from the offering, after deducting the placement agent’s fees and other estimated offering expenses payable by the Company, were approximately $7.0 million. The Company intends to use the net proceeds from the offering for the commercialization of XERAVA as well as for working capital and other general corporate purposes.
Presented XERAVA Data at the Infectious Disease Society of America’s (IDSA) Infectious Disease Week (IDWeek) 2019
In October 2019, XERAVA was featured in seven poster presentations at IDWeek 2019, which was held October 2-6 in Washington, D.C. The data lend additional support for the continued use of XERAVA in the hospital setting to treat serious, life-threating multidrug resistant infections, including complicated intra-abdominal infections (cIAI).
Effected a Reverse Stock Split
In September 2019, the Company effected a 1-for-20 reverse stock split of its common stock, bringing the Company into compliance with the minimum bid price requirement for maintaining its listing on the Nasdaq Global Select Market.
Completed Payment of Debt to Solar Capital Limited
In August 2019, the Company paid off its remaining debt to Solar Capital Limited. The Company had previously entered into a loan agreement with Solar Capital in November 2018 to support the commercial launch of XERAVA and general corporate purposes. The payoff of this debt provides the Company with long term financial flexibility.
Third Quarter 2019 Financial Results

As of September 30, 2019, Tetraphase had cash and cash equivalents of $24.5 million and 2.7 million shares outstanding. Subsequent to the end of the third quarter, the Company raised an additional $7 million, net of expenses, in an equity offering. The Company expects that its cash and cash equivalents including the equity proceeds, as well as expected revenue, will be sufficient to fund operations into the third quarter of 2020.

For the third quarter of 2019, Tetraphase reported a net loss of $16.3 million, or $6.00 per share, compared to a net loss of $19.6 million, or $7.39 per share, for the same period in 2018, driven by both increased revenues and lower operating expenses.

Revenues from sales of XERAVA were $1.0 million in the third quarter of 2019. Total revenues, including License and Collaboration Revenue and Government Revenue, were $3.3 million for the third quarter of 2019, compared to $1.2 million for the same period in 2018. Total revenues for the third quarter of 2019 consisted of XERAVA product revenue of $1.0 million, a territory expansion payment from Everest Medicines of $2.0 million and government contract revenue of $0.4 million.

Research and development (R&D) expenses for the third quarter of 2019 were $5.3 million, compared to $11.7 million for the same period in 2018. This decrease was primarily due to a decrease in activity across all of our pipeline programs as compared to the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $11.4 million, compared to $9.5 million for the same period in 2018. This increase in SG&A expenses for the third quarter of 2019 compared to the same prior-year period was primarily due to an increase in commercial-related expenses for XERAVA.

Conference Call and Webcast Information

Tetraphase will host a conference call today at 4:30 p.m. ET to discuss its financial results and provide an update on the Company. The call can be accessed by 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 2362909. To access the live audio webcast, visit the "Investors — Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Tuesday, November 12, 2019, through 7:30 p.m. ET on Tuesday, November 19, 2019 by dialing and dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 2362909. A replay of the webcast will be available by visiting Tetraphase’s website.

About XERAVA

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVA Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

On November 12, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the third quarter ended September 30, 2019 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, NOV 12, 2019, View Source [SID1234550958]).

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"We have transitioned our strategy to focus solely on our high-growth, high-margin ENHANZE drug delivery technology," said Dr. Helen Torley, president and chief executive officer. "With profitability anticipated in the second quarter of 2020 and a long runway for growth with ENHANZE, we are in a strong position to build value and return capital to investors."

Third Quarter 2019 and Recent Highlights Include:

In November 2019, the Company announced strategic actions to reposition the Company with a focus solely on its ENHANZE drug delivery technology following the announcement that the HALO-301 Phase 3 study did not meet its primary endpoint. In order to implement this strategic shift, the Company initiated an organizational restructuring to close its oncology operations. Headcount will be reduced by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020. Upon completion of the restructuring and after booking all related one-time charges, Halozyme anticipates becoming a sustainably profitable company beginning in the second quarter of 2020.
In November 2019, the Company announced that the Board of Directors has authorized the initiation of a capital return program to repurchase up to $350 million of the Company’s outstanding common stock over the next three years. The Board will regularly review this capital return program in connection with a balanced capital allocation strategy.
In October 2019, collaboration partner Roche nominated one new undisclosed target to be studied utilizing the ENHANZE technology, triggering a $10 million milestone payment to Halozyme.
In October 2019, collaboration partner Bristol-Myers Squibb initiated a Phase 1 study of relatlimab in combination with nivolumab utilizing the ENHANZE technology.
In September 2019, Roche announced that the global Phase 3 FeDeriCa study met its primary endpoint. The FeDeriCa study investigated a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using Halozyme’s ENHANZE drug delivery technology in combination with intravenous chemotherapy. Additional data from the FeDeriCa study will be the subject of a presentation at the San Antonio Breast Cancer Symposium in December, followed by regulatory submissions to health authorities worldwide anticipated in early 2020.
In September 2019, a Halozyme collaboration partner initiated a Phase 1 study in healthy volunteers for an undisclosed target utilizing the ENHANZE technology.
In August 2019, Roche initiated a Phase 1 study with OCREVUS (ocrelizumab) utilizing the ENHANZE technology in patients with multiple sclerosis.
Third Quarter 2019 Financial Highlights

Revenue for the third quarter was $46.2 million compared to $25.6 million for the third quarter of 2018. The year-over-year increase was primarily driven by higher product sales of bulk rHuPH20 to Janssen of $20.1 million. Revenue for the quarter included $16.6 million in royalties, which compared to $18.7 million in the prior year period. The decrease in royalties was mainly driven by lower sales of Herceptin SC by Roche, partially offset by higher sales of RITUXAN HYCELA in the U.S. by Roche and higher sales of HyQvia by Takeda.
Research and development expenses for the third quarter were $30.5 million, compared to $35.5 million for the third quarter of 2018. The decline in expenses was driven by reduced clinical trial activity as the Company approached the topline results readout from HALO-301.
Selling, general and administrative expenses for the third quarter were $18.0 million, compared to $14.9 million for the third quarter of 2018. The increase is due to an increase in personnel expenses related to support of the Company’s oncology operations.
Net loss for the third quarter was $25.0 million, or $0.17 per share, compared to a net loss in the third quarter of 2018 of $27.9 million, or $0.19 per share.
Cash, cash equivalents and marketable securities were $238.0 million at September 30, 2019, compared to $354.5 million at December 31, 2018.
Financial Outlook for 2019

Halozyme is updating its 2019 financial guidance ranges:

Total revenues are now expected in the range of $195 million to $205 million, compared with prior guidance of $205 million to $215 million, primarily driven by the movement of a planned Phase 3 trial start from 2019 to 2020, offset in part, by a new unplanned target nomination. Included in that total, royalties are expected in the range of $67 million to $69 million, compared with prior guidance of $72 million to $74 million;
Operating expenses in the range of $255 million to $265 million, and operating expenses excluding cost of product sales of $215 million to $225 million, both of which are unchanged from prior guidance. These guidance ranges include anticipated one-time restructuring costs of $25 million to $27 million that will be booked in the fourth quarter of 2019. The restructuring costs were offset by expense savings related to the closing of the Company’s oncology operations;
Operating cash burn of $50 million to $60 million, compared with prior guidance of $40 million to $50 million;
Year-end cash, cash equivalents and marketable securities balance is unchanged at $220 million to $230 million.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2019 today, Tuesday, November 12, 2019 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 6597916.