On November 4, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported financial results from the third quarter and nine months ending September 30, 2019, and provided a corporate update (Press release, Iovance Biotherapeutics, NOV 4, 2019, View Source [SID1234550236]).

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"We continue making great progress in developing tumor infiltrating lymphocyte (TIL) therapy, which could become the first approved cell therapy product for solid tumor indications," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "Our pivotal studies in metastatic melanoma and advanced cervical cancer are on track to complete enrollment in early 2020. We expect to submit for regulatory approval for TIL therapies lifileucel and LN-145 in late 2020. These therapies have the potential to impact the lives of thousands of patients in the U.S. with melanoma or cervical cancer that have exhausted current treatment options. Furthermore, we are very pleased to have a new IND active in order to investigate the polyclonal blood-based T cell, or PBL therapy (IOV-2001), in chronic lymphocytic leukemia (CLL). This candidate was developed based on Iovance research efforts focused on the generation of novel cell therapy products. We anticipate the initiation of IOV-CLL-01, an Iovance-sponsored trial with IOV-2001 PBL product, before the end of 2019."

Recent Achievements and Upcoming Milestones

Clinical

·Completion of enrollment of registration-enabling Cohort 4 in the C-144-01 melanoma study is expected in the first quarter of 2020. A late-breaking abstract on Independent Review Committee (IRC)-read results from Cohort 2 will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting.
·To further expand on evaluating TIL for a broader cervical patient population, we have amended this protocol and added new cohorts. The pivotal cohort, cohort 1, will treat 75 patients, as planned, who are second line metastatic cervical cancer patients that have progressed during or following systemic therapy. Completion of enrollment of Cohort 1, the pivotal cohort, of the C-145-04 cervical cancer study is expected before mid-2020. Iovance has added new cohorts to the C-145-04 study in order to investigate TIL therapy in broader treatment settings. Enrollment in these additional cohorts will not impact the timing of the completion of the pivotal cohort nor the size of the registration program. The C-145-04 study has been amended to collect additional data on early-line patients as well as late-line patients. These additional cohorts also allow access to TIL therapy when enrollment in the registration Cohort 1 is completed.

·To further its strategy of the study of TIL therapy in additional solid tumors, Iovance and Yale University have initiated an Investigator Sponsored Trial with LN-145 in patients with metastatic triple negative breast cancer (TNBC). The IND has been accepted by the FDA and the trial is expected to begin enrollment in 2020.

Regulatory

·An IND application for IOV-2001, PBL therapy for patients with CLL, was accepted by the U.S. Food and Drug Administration (FDA) and the study has been cleared to proceed. IOV-CLL-01 is a company sponsored study currently active at one clinical site. Patient dosing is planned before the end of 2019. IOV-CLL-01 is a Phase 1/2 study evaluating safety and efficacy of IOV-2001 in patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL). The study is expected to enroll up to 70 patients.

Research

·Three preclinical abstracts highlighting Iovance TIL therapy will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting. These presentations will include three poster abstracts covering expansion of TIL from core biopsies, transient genetic knockdown of PD1 in TIL and Gen 2 TIL manufacturing results from several solid tumor types. SITC (Free SITC Whitepaper) meeting takes place from Nov. 6-10, 2019, at the Gaylord National Hotel and Convention Center in National Harbor, Maryland. The SITC (Free SITC Whitepaper) meeting abstract titles are listed at View Source
·Iovance entered into a collaboration with Lytix Biopharma, to study the activity of LTX-315, an oncolytic peptide, in conjuction with TIL therapy.
·The company intends to expand its hematologic research to include mantle cell lymphoma (MCL).

Manufacturing

·The Gen 2 TIL therapy manufacturing process continues to be robust with a demonstrated success rate, as measured from the receipt of the starting material to the shipment of TIL, of 93 percent. The manufacturing success rate is comparable with rates published for the approved cell therapy treatments.

Corporate

·The company has been granted a total of seven U.S. patents for compositions and methods of treatment in a broad range of cancers related to its 22-day Gen 2 manufacturing process.

SITC Late-Breaking Abstract Information

·Title: Safety and efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update
·Author: Sarniak, A. et al.
·Abstract Number: P865
·Dates/Times: late-breaking abstract posters will be displayed Friday, Nov. 8, 2019, from 7 a.m. – 8 p.m. EST and Saturday, Nov. 9, 2019, from 7 a.m. – 8:30 p.m. EST

Third Quarter 2019 Financial Results

Net loss for the third quarter ended September 30, 2019, was $49.5 million, or $0.40 per share, compared to a net loss of $33.8 million, or $0.36 per share, for the third quarter ended September 30, 2018.

Research and development expenses were $41.6 million for the third quarter ended September 30, 2019, an increase of $13.7 million compared to $27.9 million for the third quarter ended September 30, 2018. The increase was primarily attributable to higher manufacturing costs resulting from increased capacity added to support enrollment in the pivotal and other clinical trials. In addition the increase is also due to higher personnel costs including stock-based compensation resulting from an increase in headcount as compared to the third quarter in 2018.

General and administrative expenses were $10.0 million for the third quarter 2019, an increase of $2.9 million compared to $7.1 million for the third quarter 2018. The increase was primarily attributable to increased personnel costs due to additional employees added in 2019 and additional legal fees to support the growing patent portfolio.

Nine Months Ended September 30, 2019, Financial Results

Net loss for the nine months ended September 30, 2019, was $134.0 million, or $1.08 per share, compared to a net loss of $91.0 million, or $1.01 per share, for the same period ended September 30, 2018.

Research and development expenses were $111.8 million for the nine months ended September 30, 2019, an increase of $39.4 million compared to $72.4 million for the same period ended September 30, 2018. The increase was primarily attributable to additional manufacturing and clinical trial costs resulting from higher enrollment in the clinical trials and increased personnel costs due to an increase in employees as compared to the same period in 2018.

General and administrative expenses were $30.0 million for the nine months ended September 30, 2019, an increase of $9.1 million compared to $20.9 million for the same period ended September 30, 2018. The increase was primarily attributable to higher personnel costs including stock-based compensation resulting from an increase in the number of employees and additional legal fees to support the patent portfolio.

Cash, cash equivalents, short term investments and restricted cash

At September 30, 2019, the company held $367.3 million in cash, cash equivalents, short-term investments and restricted cash compared to $468.5 million at December 31, 2018. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be between $310 and $320 million.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss these third quarter 2019 results and provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 3482317. The live webcast can be accessed in the Investors section of the company’s website at View Source

On November 4, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release third quarter financial results before the market opens on Tuesday, November 12th, 2019 (Press release, Intrexon, NOV 4, 2019, View Source [SID1234550235]). Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients and a wholly owned subsidiary of Intrexon, will host a conference call that day at 11:00 AM ET to provide Precigen business and pipeline updates.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1‑412-317-6061 (International) and providing the number 4454504 to join the Precigen Business and Pipeline Update Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source or Precigen’s website in the Presentations section at View Source

On November 4, 2019 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Credit Suisse 28th Annual Healthcare Conference on Wednesday, November 13, 2019 (Press release, Eli Lilly, NOV 4, 2019, View Source [SID1234550233]). Anne White, president of Lilly Oncology, Kimberly Blackwell, M.D., vice president, early phase clinical research, and Maura Dickler, M.D., vice president, oncology late phase development, will participate in a fireside chat at 10:35 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 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.

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.