On February 27, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, United Therapeutics, FEB 27, 2019, View Source [SID1234533733]).

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"2018 was a truly transformative year for United Therapeutics. We signed four major agreements to acquire new product candidates, including an in-licensing agreement for ralinepag, representing our largest deal to date," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "At the same time, we continued to execute against our existing commercial and clinical goals, including the successful readout of our FREEDOM-EV clinical trial, significant progress toward near-term phase III readouts for our BEAT and DISTINCT studies, and an increase to a record number of patients being treated with our treprostinil therapies."

Recent Highlights

· Closed license agreement with MannKind for Treprostinil Technosphere

· Appointed Nilda Mesa to the Board of Directors

· Health Canada approved Unituxin (dinutuximab) for high-risk neuroblastoma

· Submitted efficacy supplement to FDA to include FREEDOM-EV data in the Orenitram label

· In-licensed global rights to ralinepag, a phase III PAH drug candidate

·Presented survival data from FREEDOM-EV study of Orenitram at the Pulmonary Vascular Research Institute Annual World Congress

Financial Results for the Quarter and Year Ended December 31, 2018 compared to the same periods in 2017

Key financial highlights include (in millions, except per share data):

(1) See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below.

Revenues for the quarter and year ended December 31, 2018 decreased by $83.3 million and $97.5 million, respectively, as compared to the same periods in 2017.

Remodulin net product sales for the quarter and year ended December 31, 2018 decreased by $21.0 million and $71.9 million, respectively, as compared to the same periods in 2017. For the quarter and year ended December 31, 2018, international Remodulin net sales decreased by $30.7 million and $90.0 million, respectively, compared to the same periods in 2017, primarily due to the transfer of additional regulatory and commercial responsibilities to an international distributor in the third quarter of 2017. As a result of this transfer, we recognized $23.7 million and $47.4 million of net product sales in the quarter and year ended December 31, 2017, respectively, related to the one-time purchase of Remodulin inventory by that distributor and we reduced the price at which we sell Remodulin to that distributor. The remaining decrease was primarily due to a reduction in quantities shipped to that distributor. For the quarter and year ended December 31, 2018, U.S. Remodulin net sales increased by $9.7 million and $18.1 million, respectively, compared to the same periods in 2017, primarily due to a price increase that was implemented in April 2018, which was the first price increase for Remodulin since 2010, and an increase in the number of patients being treated with Remodulin. For the year ended December 31, 2018, these increases were partially offset by the one-time $4.5 million impact of a change in contractual minimum inventory levels with a U.S. distributor, as discussed below.

Tyvaso net product sales for the quarter and year ended December 31, 2018 increased by $14.5 million and $42.3 million, respectively, as compared to the same periods in 2017. These increases were primarily due to price increases that were implemented in April 2017 and January 2018 and the reversal in the fourth quarter of 2018 of an estimated $15.4 million liability for Medicaid rebates, of which $13.6 million was initially recorded in 2017. In addition, Tyvaso net product sales increased due to an increase in the number of patients being treated with Tyvaso. These increases were offset by (1) the impact of replacing $6.2 million of commercial Tyvaso product that our specialty pharmaceutical distributor previously used in connection with a clinical trial; and (2) the one-time $3.5 million impact of a change in contractual minimum inventory levels with a U.S. distributor, as discussed below.

Adcirca net product sales for the quarter and year ended December 31, 2018 decreased by $77.6 million and $96.0 million, respectively, as compared to the same periods in 2017. These decreases were primarily due to the launch of a generic version of Adcirca in August 2018, partially offset by price increases that were implemented by Eli Lilly and Company in May 2017 and January 2018. In addition, we increased our allowance for product returns for Adcirca by $16.4 million in the third quarter of 2018 based on our estimates of inventory held by distributors and other downstream customers that would expire unsold as a result of the increased use of a generic version of Adcirca.

Orenitram net product sales for the quarter and year ended December 31, 2018 increased by $1.6 million and $19.3 million, respectively, as compared to the same periods in 2017. These increases were primarily due to an increase in the number of patients being treated with Orenitram, a price increase that was implemented in January 2018 and, for the year ended December 31, 2018, the one-time $3.7 million impact of a change in contractual minimum inventory levels with a U.S. distributor, as discussed below.

Unituxin net product sales decreased by $0.8 million for the quarter ended December 31, 2018 and increased by $8.8 million for the year ended December 31, 2018, as compared to the same periods in 2017. For the year ended December 31, 2018, Unituxin net product sales increased due to an increase in the number of vials sold and price increases that were implemented in April and December 2017.

During the fourth quarter of 2017, we amended our agreements with one of our U.S. specialty pharmacy distributors, in part to make the monthly minimum inventory requirement consistent across Remodulin, Tyvaso and Orenitram. This change resulted in a one-time decrease in total net product sales of $4.3 million as the distributor adjusted to the new contractual inventory requirement levels in the first quarter of 2018. On an individual product basis, net product sales of Remodulin decreased by $4.5 million, net product sales of Tyvaso decreased by $3.5 million, and net product sales of Orenitram increased by $3.7 million.

(1)Refer to Share-based compensation below for discussion.

Cost of product sales, excluding share-based compensation. The decrease in cost of product sales of $14.5 million for the quarter ended December 31, 2018, as compared to the same period in 2017, was primarily attributable to a decrease in Adcirca sales.

The increase in cost of product sales of $98.8 million for the year ended December 31, 2018, as compared to the same period in 2017, was primarily attributable to a $96.9 million increase in royalty expense for Adcirca. As a result of an amendment to our license agreement with Lilly, effective December 1, 2017, our royalty rate on net product sales of Adcirca increased from five percent to an effective rate of approximately 42.5 percent.

Research and development expense. The table below summarizes research and development expense by major category (dollars in millions):

(1) Refer to Share-based compensation below for discussion.

Research and development expense, excluding share-based compensation. We continued to invest in our product pipeline during 2018, which includes products in multiple phase III clinical trials in cardiopulmonary diseases and oncology as well as programs in regenerative medicine and organ manufacturing. The increase in research and development expense of $48.4 million for the quarter ended December 31, 2018, as compared to the same period in 2017, was primarily due to an up-front payment of $45.0 million under our license agreement with MannKind.

The increase in research and development expense of $113.6 million for the year ended December 31, 2018, as compared to the same period in 2017, was driven by an increase of $95.9 million in research and development expense for the treatment of cardiopulmonary diseases, primarily due to up-front payments of $55.0 million under our license and research agreements with MannKind and $10.0 million under our license agreement with Samumed, increased spending of $22.9 million on the development of drug delivery devices, including the Implantable System for Remodulin and RemUnity, and increased spending on several clinical and non-clinical studies. Research and development expense for cancer-related projects increased by $13.9 million due to an increase in spending on the DISTINCT study. Research and development expense for organ manufacturing projects increased by $3.9 million due to increased preclinical work on technologies designed to increase the supply and distribution of transplantable organs and tissues.

Selling, general and administrative expense. The table below summarizes selling, general and administrative expense by major category (dollars in millions):

(1) Refer to Share-based compensation below for discussion.

General and administrative, excluding share-based compensation. The increase in general and administrative expenses of $6.7 million for the quarter ended December 31, 2018, as compared to the same period in 2017, primarily resulted from a $5.0 million increase in consulting fees.

The increase in general and administrative expenses of $14.7 million for the year ended December 31, 2018, as compared to the same period in 2017, primarily resulted from: (1) a $10.3 million increase in consulting expenses; (2) a $4.7 million increase in compensation due to an increase in staffing; and (3) a $4.4 million increase in acquisition and integration costs related to the SteadyMed acquisition. The increase was partially offset by a $7.1 million decrease in legal fees incurred in connection with intellectual property litigation and a Department of Justice (DOJ) investigation.

Sales and marketing, excluding share-based compensation. Sales and marketing expenses for the quarter ended December 31, 2018, remained relatively consistent as compared to the same period in 2017.

The decrease in sales and marketing expenses of $5.2 million for the year ended December 31, 2018, as compared to the same period in 2017, primarily resulted from a decrease in marketing consulting fees.

Share-based compensation. The table below summarizes share-based compensation expense (benefit) by major category (dollars in millions):

Share-based compensation. The decreases in share-based compensation of $115.7 million and $99.9 million, respectively, for the quarter and year ended December 31, 2018, were primarily due to decreases in STAP expense of $117.9 million and $120.5 million, respectively, primarily driven by a decrease in our stock price for the quarter and year ended December 31, 2018, as compared to the same periods in 2017. The decrease in STAP expense for the year-ended December 31, 2018 was partially offset by an increase of $15.5 million in stock option expense due to additional awards granted and outstanding in 2018 and a $5.1 million increase in restricted stock unit expense due to additional awards granted and outstanding in 2018.

Settlement of Loss Contingency

In December 2017, we entered into a civil Settlement Agreement with the U.S. Government to resolve a DOJ investigation. During the second quarter of 2017, we recorded a $210.0 million accrual relating to this matter, and ultimately paid this amount, plus interest, to the U.S. Government upon settlement.

Impairments of Investments in Privately-Held Companies

During the years ended December 31, 2018 and 2017, we recorded impairment charges of $53.5 million and $49.6 million, respectively, related to our investments in privately-held companies.

Income Taxes

The provision for income taxes was $169.7 million for the year ended December 31, 2018, compared to $351.6 million for the same period in 2017. The change in the provision for income taxes was primarily due to the impacts of The Tax Cuts and Jobs Act (Tax Reform) and the nondeductible portion of an accrual in 2017 in connection with a civil settlement with the DOJ. For the years ended December 31, 2018 and 2017, the effective tax rates were approximately 22 percent and 46 percent, respectively.

Non-GAAP Earnings

Non-GAAP earnings is defined as net income, adjusted for: (1) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards, and our employee stock purchase plan); (2) loss contingency; (3) impairments of investments in privately-held companies; (4) license fees; (5) impact of Tax Reform; and (6) tax impact on non-GAAP earnings adjustments.

(1)We calculated the total tax impact of non-discrete quarterly non-GAAP earnings adjustments based on our annual effective tax rates, before considering discrete items, of approximately 21 percent and approximately 32 percent for each of the quarters and years ended December 31, 2018 and 2017, respectively.

(2) The tax benefit for the year ended December 31, 2017 includes $57.0 million of benefit for the estimated loss contingency recognized during the second quarter of 2017 relating to a DOJ investigation.

(3)This non-GAAP earnings adjustment is currently not considered tax deductible.

(4) The impact of Tax Reform is a significant and unusual component of tax expense, therefore in the calculation of non-GAAP earnings, it is presented separately from the tax benefit that is derived from the other non-GAAP adjustments.

Conference Call

We will host a one-hour teleconference on Wednesday, February 27, 2019, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406 and using access code 1595239.

This teleconference is also being webcast and can be accessed via our website at View Source

On February 27, 2019 Cullinan Oncology is reported that its co-founder and Chief Scientific Officer, Biologics, Patrick Baeuerle, has been honored by the European Molecular Biology Laboratory (EMBL) (Press release, Cullinan Oncology, FEB 27, 2019, View Source [SID1234533749]). The EMBL has presented Baeuerle with the 2019 Lennart Philipson Award for his pivotal role in developing cancer immunotherapies.

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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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The award focuses on Baeuerle’s many contributions to the field of immuno-oncology, including his efforts at Micromet and subsequently Amgen where he developed bispecific antibodies known as BiTEs (Bispecific T cell Engagers). BiTEs engage the body’s T cells to facilitate the destruction of cancer cells. Baeuerle led the development of Blincyto, the first bispecific antibody approved by the FDA, for relapsed/refractory acute lymphoblastic leukemia (ALL).

"Patrick’s contributions to the fight against cancer have been significant and this recognition is well deserved. We are fortunate to have his knowledge, expertise, and leadership at Cullinan as we work to develop the next breakthroughs for patients," said Owen Hughes, CEO at Cullinan Oncology.

In addition to his role at Cullinan, Patrick Baeuerle is an Executive Partner at MPM Capital. He is also the founder of MPM-funded cancer immunotherapy companies Harpoon Therapeutics (NASDAQ: HARP), TCR2 Therapeutics (NASDAQ GS: TCRR), iOmx Therapeutics, and Maverick Therapeutics.

To access the EMBL announcement click here.

About the Lennart Philipson Award

The Lennart Philipson Award (LPA) was created to honor EMBL’s second Director General, Lennart Philipson (1982-1993). The Award recognizes outstanding and validated contributions in translational research in human health and/or technology innovation in the life sciences.

On February 27, 2019 Sirona Biochem Corp. (TSX-V: SBM) (Frankfurt: ZSB) (Xetra: ZSB) (the "Company") reported that it has closed an oversubscribed, non-brokered private placement for gross proceeds of $1,783,500 (Press release, Sirona Biochem, FEB 27, 2019, View Source [SID1234533781]). The private placement consists of 17,835,000 units, (the "Units") at a price of $0.10 per Unit. Each Unit consists of one common share and one transferable share purchase warrant, each whole warrant is exercisable into one additional common share of the Company for a period of 3 years from the date of issue at a price of $0.16 per share.

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All securities issued under the placement are subject to a statutory hold period expiring on June 27, 2019.

The Company compensated finders by way of cash fees of $62,136 and 621,360 warrants.

The financing consisted of participation by PRO-group member Shaun Chin of PI Financial, for 500,000 units, as well as two insiders. Dr. Howard Verrico, CEO, has participated with the purchase of 960,000 Units and Christopher Hopton, CFO, has participated with a purchase of 350,000 Units.

Net proceeds of the placement will be used for general working capital while the company continues its efforts toward licensing and commercialization of various pipeline products.

The Company also announced that it has granted incentive stock options under its Stock Option Plan to directors and officers of the Company for the purchase of up to 700,000 common shares at a price of $0.12 per share. Directors will receive 400,000 options at $0.12 with a 5 year expiry and Officers will receive 300,000 options at $0.12 with a 10 year expiry.

On February 27, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended December 31, 2018 (Press release, Opko Health, FEB 27, 2019, View Source [SID1234533812]).

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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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Business Highlights

RAYALDEE total prescriptions reported by IQVIA increased 166% in 4Q 2018 compared with 4Q 2017: Total prescriptions were approximately 9,300 during the fourth quarter of 2018. As of January 1, 2019, approximately 80% of prospective U.S. patients have access to RAYALDEE under their insurance plans. The Company continues to increase its commercial reach through expansion of its sales force.
Topline data from the global Phase 3 clinical trial for hGH-CTP in growth hormone deficient children is expected by the end of 2019; Enrollment completed in Japanese registration study: The global pediatric study is a pivotal, non-inferiority design comparing a single weekly administration of hGH-CTP with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the commercial market for treatment of hGH deficiency.
RAYALDEE line extension trial initiated in hemodialysis patients with SHPT: Together with its partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for patients with Stage 5 CKD who have secondary hyperparathyroidism (SHPT) and vitamin D insufficiency and are undergoing regular hemodialysis. A Phase 2 trial in this population is currently underway in the United States.
Topline data from the Phase 2b study with OPK88003, a once-weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity, is anticipated during 1Q 2019: The last patient, last visit of this Phase 2b dose-escalation study occurred in February 2019. In an earlier, 420-patient Phase 2 trial in patients with type 2 diabetes, OPK88003 was similar to exenatide extended-release (Ex ER) in reducing HbA1c levels. OPK88003 showed statistically significantly greater weight loss and lowering of total cholesterol and triglycerides compared to once-weekly Ex ER, with a good safety profile.
Appointed Jon R. Cohen, M.D. Executive Chairman and promoted Geoff Monk as President, both for BioReference Laboratories: Dr. Cohen brings more than 30 years of healthcare experience as a seasoned strategic leader with extensive and diverse experience; his track record of expanding existing business and developing new ventures, while dealing effectively with the payor universe, is well recognized in the diagnostics industry.
4Kscore utilization remained strong during 4Q 2018 with nearly 20,000 tests performed: The 4Kscore test is a blood test that gives a man with elevated prostate specific antigen (PSA) levels a personalized prediction of his chance of having or developing an aggressive form of prostate cancer. The Company is pursuing U.S. Food and Drug Administration (FDA) approval with a submission expected in the first half of 2019. OPKO announced on January 31, 2019 that Novitas Solutions, Inc. issued a notice of a future non-coverage determination for 4Kscore effective March 20, 2019. The Company is currently making efforts to have the determination rescinded or reversed.
FDA approved Claros point-of-care (POC) PSA test: On February 1, 2019, OPKO announced that the FDA approved the Company’s point-of-care Sangia Total PSA Test using the Claros 1 Analyzer. The Company is taking steps to obtain CLIA waiver for the test and analyzer, which would permit the test to be performed by most medical office personnel with minimal training, and is also planning for scale up of manufacturing capacity during 2019. OPKO plans to expand the testing menu and the next test under development is testosterone, with clinical trials currently scheduled to commence in mid-2019.
Financial Highlights

Net loss for the fourth quarter of 2018 of $76.1 million compared to $217.9 million for the comparable quarter of 2017. Net loss for both periods included unusual or non-cash items consisting of:

During the fourth quarter of 2018, the Company recorded $21.8 million of non-cash impairment to Goodwill and in-process research and development related to its active pharmaceutical ingredient business and the suspension of the Phase 2b clinical trial for its selective androgen receptor antagonist for benign prostatic hyperplasia. In the comparable period of 2017, the Company recorded a $13.2 million impairment resulting from the discontinuation by its licensee of the intravenous formulation of VARUBI;

During the fourth quarter of 2018, the Company incurred approximately $8.0 million of expenses related to defense and investigation of actions brought by the U.S. Securities and Exchange Commission (SEC) and related civil lawsuits. The Company reached a settlement agreement with the SEC in the fourth quarter of 2018, which was finalized in January 2019; and

During the fourth quarter of 2017, the Company recorded $73.3 million of adjustments to revenue from services.

Consolidated revenues for the fourth quarter of 2018 were $221.9 million compared with $161.0 million for the comparable period of 2017. During the 2018 quarter, revenue from services was $183.1 million, revenue from products was $25.4 million, including RAYALDEE revenue of $6.0 million, and revenue from licensing and intellectual property was $13.4 million.
During the fourth quarter of 2018, total operating expenses were $311.9 million, including the aforementioned impairment charges of $21.8 million as well as continued investment in the Company’s pharmaceutical pipeline, with R&D expense of $33.3 million.
The Company recorded a $28.3 million income tax benefit during the fourth quarter of 2018 primarily as a result of valuation allowance releases in foreign jurisdictions. The comparable period of 2017 includes a $61.2 million income tax provision, principally as a result of the Tax Cuts and Jobs Act ($31.8 million) as well as recording a valuation allowance against U.S. based deferred tax assets.
Subsequent to the close of the fourth quarter, on February 5, 2019, OPKO completed the sale of $200 million aggregate principal amount of 4.5% Convertible Senior Notes due 2025.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 4254518
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 4254518. The replay can be accessed for a period of time on OPKO’s website at View Source

On February 27, 2019 Silverback Therapeutics, Inc., a biotechnology company developing a pipeline of systemically delivered, locally active therapies, will present preclinical data on its lead clinical candidate, SBT6050, at the 110th meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), taking place March 29 to April 3 in Atlanta (Press release, Silverback Therapeutics, FEB 27, 2019, View Source [SID1234550490]). SBT6050 is a novel immune-modulatory conjugate that utilizes cell surface expression of HER2 to localize activation of TLR8 (toll-like receptor 8) for the treatment of HER2-expressing tumors.

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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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The presentation, titled "A Systemically Administered, Conditionally Active TLR8 Agonist for the Treatment of HER2-Expressing Tumors," is the first data to be presented on Silverback’s technology. SBT6050 is comprised of a TLR8 agonist conjugated to a HER2-directed monoclonal antibody, designed to activate myeloid cells only in the presence of HER2-expressing tumor cells with moderate-to-high expression levels. In mouse HER2-expressing tumor models, a surrogate molecule of SBT6050 drives activation of both innate and adaptive immune responses, resulting in single agent efficacy. Due to localized activation of myeloid cells, TLR conjugates do not cause an overproduction of peripheral cytokines in preclinical models. Silverback plans to advance SBT6050 into the clinic in 2020.

"Tumors resistant to checkpoint inhibition lack T cells but are replete with myeloid cells. TLR8 activation of tumor-resident myeloid cells results in potent anti-tumor immune responses, but effective delivery has been the key challenge," said Valerie Odegard, Ph.D., Silverback’s chief scientific officer. "Our preclinical studies demonstrate that systemic delivery of a TLR agonist with tumor-localized activity dramatically rewires the tumor microenvironment, resulting in durable, single agent efficacy in tumors refractory to checkpoint blockade."

"These are the first data we are disclosing publicly that demonstrate the ability of Silverback’s technology to localize delivery of potent therapies to specific sites in the body," said Peter Thompson, M.D., Silverback’s co-founder, chief executive officer and chairman. "Our data show the successful, specific delivery of a TLR agonist to HER2-expressing tumor cells upon systemic administration—thereby addressing a fundamental challenge previously limiting use of innate immune agonists to topical and intratumoral administration, largely due to toxicity arising from widespread myeloid cell activation with systemic use of these agents. With this validating data in hand, we are applying our technology to a broad range of targets and diseases."

Presentation details are as follows:

Presentation Type: Poster (Abstract 3830)
Title: A Systemically Administered, Conditionally Active TLR8 Agonist for the Treatment of HER2-Expressing Tumors
Presenter: Kara Moyes, Ph.D.
Session Date and Time: Tuesday, April 2, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B

About Silverback’s Platform Technology
Silverback’s proprietary technology and integrated R&D approach enables the design of product candidates that can be administered systemically, but that act only at the sites of disease. The approach is designed to spare healthy tissues from unwanted side effects, while modifying disease processes in a potent and targeted manner. Silverback is directing the platform to modulate fundamental pathways underlying serious or life-threatening diseases, which traditional antibody and small molecule-based approaches have not been able to successfully target with systemic dosing due to inadequate activity and/or unacceptable toxicities. Silverback has filed over 15 patent families covering the platform and related product candidates.