On November 4, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter ended September 30, 2019 (Press release, Mirati, NOV 4, 2019, View Source [SID1234550238]).

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Recent Corporate Updates:

Presented early clinical data from the Phase1/2 trial of MRTX849 on October 28, 2019 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). At the highest dose (600 mg BID), three of five (3/5) evaluable patients with non-small cell lung cancer (NSCLC) and one of two (1/2) evaluable patients with colorectal cancer (CRC) achieved a partial response (PR); the remaining patients had stable disease (SD). Across all dose levels, three of six (3/6) patients with NSCLC and one of four (1/4) patients with CRC achieved a PR. Two responding patients (1 NSCLC and 1 CRC) achieved confirmed PRs, both with continuing tumor shrinkage following their first scan. The other two patients with PRs (both NSCLC) have not had confirmatory scans. Clinical PK data demonstrated that the dose of 600 mg BID results in drug levels that meet or exceed those likely to lead to full inhibition of KRAS G12C signaling. Treatment duration ranged from 6.7- 38.6 weeks as of the data cut-off, October 11, 2019.

Published data demonstrating the efficacy of MRTX849 in preclinical studies on October 28, 2019 simultaneously with the Company’s oral presentations 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 Cancer Discovery, a journal of the American Association of Cancer Researchers.

Announced that the Company would have two presentations of interim Phase 2 data for sitravatinib in combination with nivolumab in urothelial carcinoma and oral cavity squamous cell carcinoma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 9, 2019.

Announced on July 9, 2019 that the Company had entered into a clinical collaboration agreement with Novartis to evaluate the combination of MRTX849, Mirati’s investigational KRAS G12C inhibitor and TNO155, Novartis’ investigational SHP2 inhibitor, in patients with advanced solid tumors with KRAS G12C mutations.

"The recent data presented demonstrate that MRTX849 treatment can result in clinical responses at well tolerated doses. We believe that MRTX849 clinical combinations, including the combination of MRTX849 with TNO155 in our collaboration with Novartis, will significantly increase the eligible patient population," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati. "We continue to expand and accelerate our KRAS programs and expect to continue expanding our team, including the addition of commercial talent so that we are ready to deliver our novel cancer therapies to the patients most in need."

Financial Results for the Third Quarter 2019

Cash, cash equivalents, and short-term investments were $454.2 million at September 30, 2019, compared to $222.8 million at December 31, 2018. In January 2019, we completed a public offering of common stock that provided net cash proceeds of $107.9 million. In June 2019, we completed a public offering of common stock that provided net cash proceeds of $219.9 million.

License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and nine months ended September 30, 2019 were $1.0 million and $2.8 million, respectively, compared to none and $9.5 million for the three and nine months ended September 30, 2018, respectively. The 2019 revenues relate to revenues earned in connection with a manufacturing supply services agreement with BeiGene and the 2018 revenues relate to the license the Company granted to BeiGene under the Collaboration and License Agreement.

Research and development expenses for the third quarter of 2019 were $47.4 million, compared to $23.6 million for the same period in 2018. Research and development expenses for the nine months ended September 30, 2019 were $119.9 million, compared to $67.1 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with the development of sitravatinib and MRTX849, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expense of $8.6 million during the third quarter of 2019, compared to $1.8 million for the same period in 2018, and $20.4 million during the nine months ended September 30, 2019, compared to $5.1 million for the same period in 2018.

General and administrative expenses for the third quarter of 2019 were $10.7 million, compared to $5.3 million for the same period in 2018. General and administrative expenses for the nine months ended September 30, 2019 were $30.3 million, compared to $15.3 million for the same period in 2018. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee related expense, professional services expense and facilities and insurance expense. The Company recognized general and administrative-related share-based compensation expense of $6.5 million during the third quarter of 2019, compared to $2.2 million for the same period in 2018, and $18.4 million during the nine months ended September 30, 2019, compared to $6.5 million for the same period in 2018.

Net loss for the third quarter of 2019 was $54.3 million, or $1.38 per share basic and diluted, compared to net loss of $27.6 million, or $0.85 per share basic and diluted for the same period in 2018. Net loss for the nine months ended September 30, 2019 was $140.9 million, or $3.83 per share basic and diluted, compared to net loss of $70.1 million, or $2.31 per share basic and diluted for the same period in 2018.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small

cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified, KRAS G12C-positive advanced solid tumors.

On November 4, 2019 MAX BioPharma, Inc. (www.maxbiopharma.com) reported that published two articles describing its anti-tumorigenic oxysterol lead compounds in the peer-reviewed journal, Cells (Press release, MAX BioPharma, NOV 4, 2019, View Source [SID1234550237]). Oxy186 (View Source) and Oxy210 (View Source) are derived from the Company’s Oxysterol Therapeutics platform of proprietary oxysterols. MAX BioPharma is currently optimizing the compounds for oral dosing and performing pre-clinical studies required by the FDA for clinical development and commercialization.

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MAX BioPharma’s anti-tumorigenic oxysterol, Oxy186, inhibits the Hedgehog signaling pathway, which is dysregulated and activated in many human tumors including pancreatic and lung cancers. Oxy210, an analogue of Oxy186, inhibits Hedgehog signaling as well as transforming growth factor (TGF)beta signaling. Oxy210 and Oxy186 have unique mechanisms of action compared to other Hedgehog and TGFbeta signaling inhibitors that are commercially available or under clinical development. MAX BioPharma is focusing its efforts to develop these compounds for lung and pancreatic cancers, which still have huge unmet medical needs. Oxy210 and Oxy186 have favorable pharmacokinetic and safety profiles, are scalable, and were found to inhibit tumor cell growth, invasive activity, and epithelial-mesenchymal transition, a hallmark of cancer metastasis. In addition, Oxy210 was found to inhibit development of chemoresistance by tumor cells and to enhance the cytotoxic effects of carboplatin on lung cancer cells in vitro.

MAX BioPharma has collaborated with Dr. Ying Zhang of the National Cancer Institute (NCI) under a Materials-Cooperative Research and Development Agreement (M-CRADA) and with academic investigators. These collaborations are evaluating the potential of the oxysterols to be potent, orally bioavailable, and safe therapies for cancer. "Given the important role of Hedgehog signaling in acute myeloid leukemia (AML) and the recent FDA approval of a Hedgehog pathway inhibitor, DaurismoTM (glasdegib) by Pfizer, for the treatment of AML, we are excited to begin examining the potential of oxysterols for targeting AML" explains Dr. William Matsui, co-founder of MAX BioPharma and Professor of Oncology and Deputy Director of LIVESTRONG Cancer Institutes at the University of Texas in Austin. MAX BioPharma is seeking strategic partnerships with biotechnology and pharmaceutical companies that have the expertise and resources to further the development of oxysterols as a cancer therapeutic towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A financing round to support the advancement of its therapeutic development programs. "We are extremely excited about the progress of our oncology program and we believe that our findings will be groundbreaking in finding more effective cures for cancer," says Dr. Farhad Parhami, President & CEO of MAX BioPharma.

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.