On November 4, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the third quarter ended September 30, 2019 and provided a general update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, NOV 4, 2019, View Source [SID1234550231]).

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"We believe the Breakthrough Therapy Designation we received from the FDA underscores the potential for ripretinib to transform the treatment landscape for patients with advanced GIST," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Based on the positive results from the Phase 3 INVICTUS study, we remain on track for our planned NDA submission for ripretinib in the first quarter of 2020. In addition, we provided important new clinical updates on rebastinib and DCC-3014 at the recent AACR (Free AACR Whitepaper)-NCI-EORTC meeting and we continue to progress our broad portfolio of novel product candidates all discovered here at Deciphera."

Recent Highlights and Upcoming Milestones

Ripretinib
Presented positive top-line data from the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib in fourth-line and fourth-line plus GIST patients.
FDA granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
Company expects to submit a New Drug Application (NDA) to the FDA for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib in the first quarter of 2020.
Presented updated data from the ongoing Phase 1 clinical study of ripretinib in patients with second-line through fourth-line plus GIST at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The Company believes the updated data continue to support the ongoing INTRIGUE pivotal Phase 3 clinical study comparing ripretinib to sunitinib for the treatment of second-line GIST patients who have previously received imatinib.
Established ripretinib Expanded Access Program (EAP) for patients with locally advanced unresectable or metastatic GIST who have received treatment with prior therapies. The ripretinib EAP provides a pathway for eligible patients to gain access to this investigational medicine outside of clinical trials when no comparable or satisfactory alternative therapy option is available.
DCC-3014
Presented data from the Phase 1 dose escalation study of DCC-3014, an oral inhibitor of CSF1R, in patients with advanced solid tumors, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The Phase 1 data demonstrated tolerability, pharmacokinetics and biomarker mechanistic proof-of-concept in patients with advanced malignancies.
Company plans to present preliminary data from initial tenosynovial giant cell tumor (TGCT) patients at the 2019 Connective Tissue Oncology Society (CTOS) Annual Meeting being held November 13-16 in Tokyo, Japan.
Rebastinib
Presented data from the ongoing Phase 1b/2 clinical study of rebastinib, an oral TIE2 kinase inhibitor, in combination with paclitaxel at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In Part 1 of the ongoing Phase 1b/2 study, the combination of rebastinib and paclitaxel exhibited encouraging preliminary anti-tumor activity across treatment arms and was generally well tolerated.
DCC-3116
Presented preclinical data for DCC-3116, a potential first-in-class autophagy inhibitor designed to treat mutant RAS cancers at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In vivo and in vitro data demonstrated DCC-3116 is a potent, selective and tight-binding inhibitor of ULK kinase, and represents a differentiated approach to autophagy inhibition and a potential first-in-class opportunity for a new therapeutic modality in mutant RAS cancers.
Recent Corporate Updates

In October 2019, Deciphera announced the appointment of Matthew L. Sherman, M.D. as Executive Vice President and Chief Medical Officer. Dr. Sherman brings over 25 years of experience as a physician-scientist in clinical drug development in oncology and hematology at leading biotechnology and pharmaceutical companies.
In the third quarter of 2019, Deciphera announced the closing of an underwritten public offering of 12,432,431 shares at a public offering price of $37.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 1,621,621 shares of common stock. Total net proceeds to Deciphera were approximately $431.8 million, after deducting underwriting discounts and commissions and other offering expenses.
Third Quarter 2019 Financial Results

Cash Position: As of September 30, 2019, cash, cash equivalents and marketable securities were $634.6 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. Deciphera expects its cash, cash equivalents and marketable securities as of September 30, 2019 will enable the Company to fund its operating expenses, capital expenditure requirements and debt service payments into 2022.
R&D Expenses: Research and development expenses for the third quarter of 2019 were $40.4 million, compared to $20.6 million for the same period in 2018. The increase was primarily due to the Company’s clinical trial costs related to the INTRIGUE pivotal Phase 3 study in second-line GIST. Personnel-related costs increased to $11.6 million primarily due to an increase in headcount and stock-based compensation expense in the research and development function. Personnel-related costs for the third quarters of 2019 and 2018 included non-cash, stock-based compensation expense of $2.0 million and $1.1 million, respectively. Facility-related and other costs included increased consultant fees of $0.4 million and increased costs incurred in connection with our early-stage drug discovery programs of $0.2 million.
G&A Expenses: General and administrative expenses for the third quarter of 2019 were $18.0 million, compared to $5.3 million for the same period in 2018. The increase was primarily due to increases in headcount and stock-based compensation expense in the Company’s general and administrative function. Non-cash, stock-based compensation was $2.7 million and $1.5 million for the third quarters of 2019 and 2018, respectively.
Net Loss: For the third quarter of 2019, Deciphera reported a net loss of $56.2 million, or $1.28 per share, compared with a net loss of $24.4 million, or $0.65 per share, for the same period in 2018.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, November 4, 2019, at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 1181263. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

On November 4, 2019 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that management will present at the upcoming Stifel 2019 Healthcare Conference taking place November 19-20, 2019 in New York, NY (Press release, Zymeworks, NOV 4, 2019, View Source [SID1234550247]).

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The Company’s presentation will be on Tuesday, November 19, 2019 at 8:00 a.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

On November 4, 2019 AVEO Oncology (NASDAQ: AVEO) reported a regulatory update following a meeting with the U.S. Food and Drug Administration (FDA) to discuss results from the August 2019 overall survival (OS) analysis of the TIVO-3 trial and the Company’s proposal to proceed with a New Drug Application (NDA) for tivozanib (Press release, AVEO, NOV 4, 2019, View Source [SID1234550264]).

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TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma (RCC). The TIVO-3 trial was designed to address the FDA’s concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the Company’s initial RCC pivotal trial, the FDA found that the inconsistent progression free survival (PFS) and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.

The Company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate. The August 2019 analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio (HR) of 0.99 at two years from the last patient enrolled in the study.

In the FDA’s preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the Company not submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the Company’s current interim OS results do not abrogate the FDA’s concerns over detriment and that those results may worsen with final analysis at 263 events, and that the median OS for tivozanib is worse than that of sorafenib.

In view of the changing first-line treatment landscape as well as the FDA’s continued concerns, the Company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC. At the meeting, the FDA acknowledged AVEO’s responses and reiterated its concerns about the survival information and the totality of data. The FDA noted that the choice to submit the data is the Company’s, and that a discussion with the Oncologic Drug Advisory Committee will likely be required. The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan (SAP) with a planned OS update based on the projected number of events at that time.

AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in the first quarter of 2020. AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the Company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA. The FDA and the Company agreed that if the final analysis yields an OS HR above 1.00, the Company will withdraw its NDA application.

"During the meeting with the FDA, we believe that we established an appropriate path forward toward filing an NDA for tivozanib in the near term and a final analysis plan for OS," said Michael Bailey, president and chief executive officer of AVEO. "The continued separation of the PFS curves and the positive trend in OS HR observed from the first to the second interim analysis, together with tenfold more patients remaining progression free and on tivozanib vs. sorafenib therapy, make us believe that the final OS results will not worsen."

About TIVO-3

The TIVO-3 trial was designed to enroll patients with RCC who have failed at least two prior regimens, including VEGFR-TKI therapy. Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients were randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival (PFS). Secondary endpoints include overall survival (OS), overall response rate (ORR), and safety and tolerability. TIVO-3, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a regulatory submission of tivozanib in the U.S. as a treatment for RCC in multiple lines of therapy. TIVO-3 patients were exclusively enrolled in North America, Western Europe, and Central Europe.

About Tivozanib

Tivozanib (FOTIVDA) is an oral vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.

On November 4, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1, reported financial results for the third quarter of 2019 (Press release, Agenus, NOV 4, 2019, View Source [SID1234550212]).

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"We have made solid progress this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We expect clinical readouts from six separate antibody programs in 2020 as our robust pace continues. We expect to commence combo trials of our NexGen CTLA-4 with our own PD-1 this month. 2020 is expected to be an important year of data generation, substantial milestone payments and prudent collaborations for Agenus. We look forward to discussing these developments in more detail during our call and at our R&D day on November 15th."

Achievements
Delivered on partnership programs; received additional cash milestones
Received $22.5 million from Gilead as milestone payment for IND acceptances of AGEN1423 (now GS-1423), AGEN1223, & AGEN2373
CTLA-4 & PD-1 trials advance
2L cervical cancer trial designed to support BLA via accelerated pathway
Combination trial completes accrual and interim analysis
Monotherapy trial is on track to complete accrual and interim analysis by year-end
AGEN1181 (NexGen CTLA-4) trial advancing; combos with AGEN2034 (PD-1) to start
QS-21 Updates
Sales of Shingrix exceed $1Bn; eliminating HCR debt obligation and nearing milestone triggers of up to $40M
AgenTus Cell Therapy Business:
IND for AgenTus allogeneic cell therapy on track by year end; combos with Agenus check point antibodies planned in 2020
Partnership and private financing discussions are underway
Dr. Walter Flamenbaum appointed CEO of AgenTus
Third Quarter 2019 Financial Results

We ended the third quarter of 2019 with a cash balance of $93 million as compared to $53 million at December 31, 2018.

Cash used in operations for the quarter ended September 2019 was $28 million compared to $25 million for the same period in 2018. Cash provided by operations for the nine months ended September 2019 was $13 million as compared to cash used in operations of $95 million for the same period in 2018.

For the third quarter ended September 30, 2019, we reported net loss of $46 million or $0.33 per share compared to a net loss for same period in 2018 of $34 million, or $0.29 per share. For the nine months ended September 30, 2019, we reported a net loss of $81 million or $0.58 per share compared to a net loss for the same period in 2018 of $113 million or $1.04 per share.

During the nine months ended September 2019 we recognized revenue of $116 million which includes revenue from our transaction with Gilead and non-cash royalties earned. This compares to revenue of $30 for the nine months ended September 2018. Through the third quarter of 2019 we also recorded $30 million of non-cash interest expense due to our transaction with HCR related to the sale of future royalties.

Conference Call, Webcast and Prepared Statement Information

Date: Monday, November 4, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (844) 492-3727
International Dial-in Number: (412) 317-5118
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On November 4, 2019 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2019 and provided a corporate update (Press release, DURECT, NOV 4, 2019, View Source [SID1234550232]).

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Total revenues were $10.8 million and net loss was $2.0 million for the three months ended September 30, 2019 as compared to total revenues of $8.0 million and net loss of $2.7 million for the three months ended September 30, 2018.

At September 30, 2019, cash and investments were $57.1 million, compared to cash and investments of $34.5 million at December 31, 2018. In September, DURECT earned a $10 million milestone under its agreement with Gilead; payment of the milestone was received in October and is therefore not reflected in the cash and investments figure as of September 30, 2019. Debt at September 30, 2019 was $21.0 million, which included partial accrual for the final payment of our term loan.

"Recent progress continues on both our proprietary and partnered clinical development programs, led by the completion of the DUR-928 Phase 2a alcoholic hepatitis study. The strength of the data from this study is underscored by its selection as an oral late-breaking presentation and for inclusion in the ‘Best of The Liver Meeting’ summary slide deck at the upcoming Liver Meeting 2019," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we completed enrollment in the DUR-928 psoriasis trial and passed the half way point for enrollment in the DUR-928 NASH trial. In September we earned a $10 million development milestone under our exclusive license agreement with Gilead for a long-acting injectable HIV investigational product utilizing DURECT’s SABER technology."

Update on Selected Programs and Transactions:

Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company’s Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcoholic hepatitis (AH) and acute kidney injury (AKI), in chronic liver diseases such as non-alcoholic steatohepatitis (NASH), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.

Clinical Trials

Alcoholic Hepatitis (AH)

We completed the Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis (AH). The final enrollment for the trial consists of 12 severe patients (Model for End-Stage Liver Disease (MELD) 21-30) and 7 moderate patients (MELD 11-20) for a total of 19 AH patients. After being discharged on day 2, one patient did not return for the scheduled day 7 and day 28 follow up visits; therefore Lille, bilirubin and MELD data reported below are based on 18 patients. Patients treated with DUR-928 had statistically significant reductions from baseline in bilirubin (day 7 and 28) and MELD (day 28), as well as statistically significantly lower Lille scores, compared with a historical control group (n=15) from a University of Louisville (UL) AH study1. All 19 patients treated with DUR-928 survived the 28-day follow-up period.

The study results have been selected for an oral presentation as part of the late-breaking session of The Liver Meeting 2019. Additionally, the results have been selected for inclusion in the ‘Best of The Liver Meeting’ summary slide deck in the alcohol-related liver disease category.

Our advisor, Dr. Craig McClain from the University of Louisville (UL), shared anonymized data from his study, in which 15 AH patients with initial MELD scores ranging from 15-30 received either supportive care alone (n=8) or supportive care with corticosteroids (n=7).

Tarek Hassanein, M.D., one of the trial’s principal investigators, will deliver the oral late-breaking presentation detailing trial results.

Oral Late-Breaking Presentation Details:

Title:

Safety and Efficacy of DUR-928: A Potential New Therapy for Acute Alcoholic Hepatitis

Date: Tuesday, November 12, 2019

Time: 8:30 a.m. Eastern Time

Location: Auditorium, Hynes Convention Center

Session Title: Late-Breaking Abstract Oral Session II

Presentation Type: Oral, Late-Breaking Session

Publication Number: LO9

In a separate poster presentation, Craig McClain, M.D., will present additional comparative data from the Phase 2a clinical trial of DUR-928 and a control group from a contemporaneous AH trial conducted at University of Louisville.

Poster Presentation Details:

Title: DUR-928 Therapy of Acute Alcoholic Hepatitis: A Pilot Study

Date: Sunday, November 10, 2019

Time: 12:00 – 2:00 p.m. Eastern Time

Presentation Type: Poster Presentation

Location: Hynes Convention Center, Hall B

Publication Number: 1376

Lille scores are used in clinical practice to help determine the prognosis and response for AH patients after 7 days of treatment. The lower the Lille score, the better the prognosis is for the AH patient. Patients with a Lille score below 0.45 have a 6-month survival rate of 85% vs. those with Lille scores of above 0.45, who have only a 25% 6-month survival rate (Louvet A et al. Hepatology 2007; 45: 1348-54). In our study, the median Lille score for the AH patients treated with DUR-928 was 0.10. 89% (16/18) had a Lille score below 0.45. The median Lille score among the UL cohort of 15 patients treated with either supportive care or supportive care with corticosteroids was 0.41, with 53% (8/15) having a Lille score below 0.45.

DUR-928 was well tolerated in all patients, with no drug-related serious adverse events reported at any dose level. Drug exposures were dose proportional and were not affected by the severity of the disease.

About the AH trial: Patients with moderate and severe AH were treated with intravenously administered DUR-928 in this open label, dose escalation multi-center U.S., Phase 2a clinical trial. Final enrollment was 19 patients comprised of: 8 patients (4 moderate and 4 severe) dosed at 30 mg, 7 patients (3 moderate and 4 severe) dosed at 90 mg and 4 patients (4 severe) dosed at 150 mg. The objectives of this study included assessment of safety, PK and pharmacodynamic (PD) signals, including liver biochemistry, biomarkers, and prognostic scores, including the Lille score, following DUR-928 treatment.

AH is an acute form of alcoholic liver disease (ALD), associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure (Journal of Hepatology 2019, vol. 70; 314-318). An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days (PLOS ONE | View Source, February 14, 2018). According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 117,000 hospitalizations for patients with alcoholic hepatitis in 2016. From a recent publication analyzing the mortality and costs associated with alcoholic hepatitis, the cost per patient is estimated at over $50,000 in the first year (Alcohol 2018:71:57-63). ALD is one of the leading causes of liver transplants in the US, each of which cost over $800,000.

Non-Alcoholic Steatohepatitis (NASH)

We have enrolled over half of the expected patients in a Phase 1b randomized and open-label clinical study being conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. DUR-928 (at doses of 50 mg QD, 150 mg QD or 300 mg BID) is administered orally for 28 consecutive days with approximately 20 patients per dose group (targeting 15 evaluable) for a total of approximately 60 patients in the trial.

Key endpoints include safety, PK, and signals of biological activities, including clinical chemistry and biomarkers as well as liver fat content by imaging.

We expect to complete the study in the first half of 2020 and announce top-line study results following completion of the trial.

Psoriasis

We have completed enrollment in a Phase 2a, randomized, double-blind, vehicle-controlled proof-of-concept clinical trial, in which DUR-928 is applied topically once-daily for four weeks in patients with mild to moderate plaque psoriasis. The trial is being conducted at multiple clinical sites in the U.S. Over twenty patients have been enrolled with the goal of obtaining approximately 15 evaluable patients. Each patient serves as their own control, applying DUR-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. After the treatment period, patients are followed for an additional four weeks. The primary efficacy endpoint is the change in local psoriasis scores from baseline in the DUR-928-treated plaques compared to the vehicle-treated plaques.

We expect to announce top line data from this study by the end of 2019.

POSIMIR (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.

In July 2019, the FDA agreed to file the submitted response to the Complete Response Letter (CRL) as a complete Class 2 Resubmission and initially assigned a user fee goal date of December 27, 2019. The FDA subsequently has tentatively scheduled an Advisory Committee meeting for January 16, 2020; a new user fee goal date has not been assigned.

The effort to evaluate the program, develop a strategy for filing the response, and preparing the response, has been under the direction of Dr. Lee Simon, who was formerly FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products. Dr. Simon is also leading our preparation efforts for the Advisory Committee meeting.

Gilead Agreement. In July 2019, we entered into an agreement with Gilead Sciences, Inc. (Gilead) granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV investigational product utilizing our SABER technology. Gilead also received exclusive access to the SABER platform for HIV and Hepatitis B Virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV. Under the terms of the agreement, Gilead made an upfront payment to us of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered royalties on product sales. In September 2019, we earned the first $10 million milestone payment under this program, which was received in the fourth quarter of 2019. Gilead has the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory and sales-based milestones as well as tiered royalties on sales. The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.

Earnings Conference Call

We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss third quarter 2019 results and provide a corporate update:

Toll Free:877-407-0784

International:201-689-8560

Conference ID:13695661

Webcast:View Source

A live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.