On May 5, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, reported quarterly financial results for the first quarter period ended March 31, 2021, and provided a corporate overview and business update (Press release, Ampio, MAY 5, 2021, View Source [SID1234579234]).

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Mr. Michael Macaluso, President and Chief Executive Officer, commented, "This has been an important quarter for Ampio, with noted progress across our therapeutic platform. For example, the FDA has recently responded to our plans for the AP-013 Phase III trial for the intra-articular injection of Ampion for patients suffering from severe osteoarthritis of the knee (OAK). The response not only provides us with flexibility for maintaining the Special Protocol Assessment (SPA) but, in addition, allows us to consider several alternative paths forward to an optimal solution that may include strategic discussions with potential partners for the commercialization, and expansion of osteoarthritis indications, of Ampion."

"We were also encouraged with the results of the AP-014 Phase I clinical trial of inhaled Ampion for COVID-19 patients. The study met its primary endpoint of safety and tolerability, and a 78% reduction in all-cause mortality was observed for patients treated with Ampion compared to Standard of Care (SOC). Approximately 24% of the patients receiving SOC alone died during the study, compared with 5% treated with Ampion."

"Our results from the AP-014 trial are strong and compelling," continued Macaluso, "and we look forward to promptly enrolling patients in a set of double-blind, placebo-controlled Phase II trials utilizing Ampion in COVID-19 patients with inhalation and intravenous routes of drug delivery. We will be looking for confirmation of the efficacy results seen in our Phase I trial in order to move quickly in applying for Emergency Use Authorization."

Mr. Michael Macaluso, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka, Chief Operating Officer and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).

The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) Phase I clinical trial of Ampion met its primary endpoint, and demonstrated improvement in all-cause mortality
Double-blind, placebo-controlled Phase II trials utilizing (i) inhaled Ampion for patients impacted from COVID-19 induced respiratory distress and (ii) intravenously delivered Ampion for COVID-19 patients, will begin enrollment in the U.S. during the second quarter of 2021
OAK Clinical Trial 2021 Timeline / Update

Positive FDA response provides guidance on multiple pathways forward on paused AP-013 Phase III trial in osteoarthritis of the knee (OAK)
Long-COVID and Other Clinical Trial 2021 Timeline / Update

Phase I Long-COVID trial is expected to commence enrolling patients in the U.S. during the second quarter of 2021
Update on Other Pre-Clinical Research Programs

Results of pre-clinical study demonstrated that Ampion inhibits pro-inflammatory pathway in types of immune cells implicated in COVID-19 and Lupus Nephritis
Ampion shown to suppress TRL7 signaling, and thereby, reducing the pro-inflammatory chemokine, CXCL10
Financial Results for the First Quarter Period Ended March 31, 2021

Cash and cash equivalents totaled $15.8 million at March 31, 2021, compared to $17.3 million at December 31, 2020. The decrease of $1.5 million is primarily attributable cash used to fund the operating activities for the period of $4.1 million; partially offset by net proceeds received from the utilization of our at-the-market (ATM) equity offering and warrant exercises totaling $2.6 million and $0.1 million, respectively.

Research and development expenditures for the first quarter period ended March 31, 2021 were $2.3 million, compared to $4.3 million for the same period in 2020. The decrease in research and development expenses of $2.0 million, or 46%, for the first quarter period ended March 31, 2021 compared to the amounts for the same period in 2020 was primarily due to the overall decrease in clinical trial and sponsor research related expenses related to the AP-013 study being temporarily paused in April 2020 and continuing through current as a result of the COVID-19 pandemic. The pause of this study resulted in a reduction of expenses totaling $2.4 million which was partially offset by $0.2 million of expenses associated with the AP-014 (inhaled Ampion) and AP-017 (intravenous Ampion) Phase I studies; both of which were initiated in periods subsequent to March 31, 2020.

General and administrative expenses for the first quarter period ended March 31, 2021 were $1.5 million, compared to $1.8 million for the same period in 2020. The decrease in general and administrative expenses for the first quarter period ended March 31, 2021 compared with the same period for 2020 is primarily due to the decrease in professional fees as a result of the decrease in legal costs which is primarily attributable to both the securities class action and derivative cases being closed in the third quarter of 2020.

Other income was $0.2 million for the first quarter period ended March 31, 2021 compared to other income of $0.8 million for the same period in 2020. For the first quarter period ended March 31, 2021 the other income relates directly to the warrant derivative gain recorded for the investor warrants as a result of the warrant exercises during the period which reduced the liability and was partially offset by the increase in stock price of 6.3% during the period. The derivative gain of $0.8 million recorded for the 2020 period related to the reduction of the derivative liability resulting from the 28.2% reduction of stock price during the period.

Net loss for the first quarter period ended March 31, 2021 was $3.7 million, or $0.02 on a fully diluted per share basis, compared to a net loss of $5.2 million, or $0.04 on a fully diluted per share basis, for the same period in 2020. The lower net loss reported for the first quarter period ended March 31, 2021 compared to the same period for 2020 is primarily attributable to a reduction in clinical trial and sponsor related research expenses of $2.4 million as a result of pausing the AP-013 study in early 2020 due to the COVID-19 pandemic; partially offset by the higher reported derivative gain resulting from the reduction of the derivative liability associated with the unexercised investor warrants.

The total shares of common stock outstanding were 195,689,128 at March 31, 2021, compared to 193,378,996 at December 31, 2020.

Financial Guidance

Based on its current operating plans and expected access to equity financing, Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund research and development programs and business operations through the second quarter of 2022.

Conference Call and Webcast

Ampio will host a conference call today at 4:30pm EST (1:30 pm PST) to discuss these first quarter 2021 results and provide a corporate business update.

The live call / webcast may be accessed as follows:

A replay of the conference call will also be available from the Investors Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On May 5, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations (Press release, Hoffmann-La Roche, MAY 5, 2021, View Source [SID1234579149]).

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"We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease."

Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, giving physicians and patients greater flexibility on how they manage their treatment.

This approval is based on data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106) in people with high PD-L1 expression (TC3 or IC3-wild-type [WT]).1 Safety for Tecentriq was consistent with its known safety profile, with no new safety signals identified. Grade 3–4 treatment-related adverse events were reported in 12.9% of people receiving Tecentriq, compared with 44.1% of people receiving chemotherapy.2

Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in markets around the world. In Europe, Tecentriq now has four approved indications in NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy).

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.

About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study evaluating the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with Stage IV non-squamous or squamous NSCLC. The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumour aberrations, and were randomised 1:1 to receive:

Tecentriq monotherapy, until disease progression (or loss of clinical benefit, as assessed by the investigator), unacceptable toxicity or death; or
Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint was OS by PD-L1 subgroup (TC3/IC3-WT; TC2,3/IC2,3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints included investigator-assessed progression-free survival, objective response rate and duration of response.

At the World Conference on Lung Cancer 2020 (January 2021), an updated, exploratory OS analysis in the PD-L1 high (TC3 or IC3)-WT population showed a continued OS benefit at a median follow-up of 31.3 months (HR=0.76, 95% CI: 0.54–1.09). Median OS in the Tecentriq arm was the same as observed at the previous analysis (20.2 months); in the chemotherapy arm, median OS was 14.7 months.3 Data from this exploratory OS analysis were also submitted to the European Commission.

PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells. Immunotherapies such as Tecentriq block PD-L1 from binding to immune cells, allowing the immune system to detect and destroy tumour cells. In IMpower110, patients were classified as PD-L1 high if they had PD-L1 on at least 50% of tumour cells or if PD-L1 expressing tumour-infiltrating cells were covering at least 10% of the tumour area.

About NSCLC
Lung cancer is the one of the leading causes of cancer death globally.4 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.4 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.5

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

On May 5, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported business highlights and financial results for the first quarter ended March 31, 2021 (Press release, Fate Therapeutics, MAY 5, 2021, View Source [SID1234579182]).

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"During the first quarter of 2021, we strengthened our balance sheet by raising $460 million and successfully positioned our off-the-shelf, iPSC-derived NK cell pipeline to achieve significant clinical milestones across our disease franchises throughout the remainder of the year. We look forward to sharing Phase 1 clinical data from our FT516 and FT538 programs in relapsed / refractory AML at an investor event to be held alongside the ASGCT (Free ASGCT Whitepaper) conference. We are also pleased with the clinical expansion of our FT538 program into solid tumors, where we plan to combine with FDA-approved monoclonal antibodies targeting EGFR, HER2, and PDL1," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "While we are disappointed that the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft-versus-host disease following allogeneic stem cell transplant, we will now turn our full attention and resources to our deep pipeline of off-the-shelf, iPSC-derived cancer immunotherapies. We would like to sincerely thank the patients, caregivers and investigators who participated in the clinical investigation of ProTmune, and we intend to share our clinical findings with that community."

AML Disease Franchise

Interim Phase 1 Clinical Data for FT516 and FT538 Programs to be Featured at Upcoming Investor Event. On May 13, the Company plans to host a virtual investor event to highlight interim Phase 1 clinical data from its FT516 (hnCD16 engineered iPSC-derived NK cell) and FT538 (hnCD16 + IL-15RF + CD38KO engineered iPSC-derived NK cell) programs for the treatment of relapsed / refractory acute myeloid leukemia (AML). The Phase 1 study of FT516 as a monotherapy (NCT04023071) has enrolled the first and second dose cohorts (90 million and 300 million cells per dose, respectively), and dose escalation is ongoing with enrollment in the third dose cohort (900 million cells per dose). The Phase 1 study of FT538 as a monotherapy (NCT04614636) is enrolling in the first dose cohort (100 million cells per dose). The Company is also working with investigators from the Masonic Cancer Center, University of Minnesota to initiate a Phase 1 clinical trial of FT538 in combination with the CD38-targeted monoclonal antibody daratumumab in patients with relapsed / refractory AML, a therapeutic strategy designed to exploit the product candidate’s proprietary high-affinity, non-cleavable (hnCD16) receptor and CD38 knock-out (CD38KO) to target and eliminate CD38+ leukemic blasts.
ASGCT Symposium to Highlight Adaptive NK Cell Features and Functionality of FT538. At the 24th Annual American Society of Gene & Cell Therapy Meeting (ASGCT) (Free ASGCT Whitepaper) to be held virtually from May 11-14, Dr. Jeffrey S. Miller, Professor of Medicine, University of Minnesota and Deputy Director of the Masonic Cancer Center, plans to present preclinical data demonstrating that the metabolic, transcriptional and functional properties of FT538 are substantially similar to those of adaptive NK cells, a discrete subset of memory-like NK cells with superior effector function. First described as a well-defined subset of NK cells that expand in cytomegalovirus (CMV) seropositive individuals (Gumá et al., 2004), adaptive NK cells exhibit increased effector function, enhanced persistence, resistance to oxidative stress, and potent serial cytotoxicity. Dr. Miller’s presentation is scheduled to be held on May 11 during a session entitled Recent Advances and Future Directions of Gene and Cellular Therapies in Immune Oncology.
B-cell Malignancy Disease Franchise

New FT516 Phase 1 Clinical Data for B-cell Lymphoma to be Presented at ASCO (Free ASCO Whitepaper). Dose escalation is ongoing with enrollment in the fourth dose cohort (900 million cells per dose) in the Phase 1 clinical trial to assess the safety and determine the maximum dose of FT516 in combination with CD20-targeted monoclonal antibody therapies for the treatment of relapsed / refractory B-cell lymphoma (BCL) (NCT04023071). The Company plans to present new clinical data from the Phase 1 study as part of a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) being held virtually from June 4-8. In December 2020, the Company reported positive interim data from the second and third dose cohorts (90 million and 300 million cells per dose, respectively), with three of four patients achieving an objective response including two complete responses.
Submitted FT596 Protocol Amendment to FDA to Assess Multi-dose Treatment Schedule. The Phase 1 clinical trial of FT596 (CAR19 + hnCD16 + IL-15RF engineered iPSC-derived NK cell) is designed to assess the safety and determine the maximum dose of FT596 as a monotherapy and in combination with CD20-targeted monoclonal antibody therapies for the treatment of relapsed / refractory BCL and chronic lymphocytic leukemia (CLL) (NCT04245722). Dose escalation of the single-dose treatment schedule is ongoing with enrollment in the third dose cohort (300 million cells) as monotherapy and in combination with rituximab for the treatment of BCL, and in the first dose cohort (30 million cells) as a monotherapy for the treatment of CLL. The Company has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) to also assess administration of multi-dose treatment schedules for FT596.
FT819 Product Attributes to be Featured in Oral Presentation at ASGCT (Free ASGCT Whitepaper). The Company is preparing to initiate a multi-center Phase 1 clinical trial of FT819, the first-ever off-the-shelf, allogeneic CAR T-cell therapy derived from a clonal master iPSC line, for patients with BCL, CLL, or acute lymphoblastic leukemia (ALL). In an oral presentation at ASGCT (Free ASGCT Whitepaper), the Company plans to describe the generation of the clonal master engineered iPSC line for FT819 using its proprietary iPSC platform, and to present preclinical data of FT819 characterizing its phenotypic and functional profile, including its expression of memory, activation and exhaustion markers, and its anti-tumor activity in comparison to primary CAR T cells. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy including a novel 1XX CAR signaling domain targeting CD19+ malignancies (1XX-CAR19) that extends T-cell effector function without eliciting exhaustion; integration of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which promotes uniform CAR expression and enhances T-cell potency; and complete bi-allelic disruption of T-cell receptor expression to prevent graft-versus-host disease.
Multiple Myeloma Franchise

Phase 1 Study for FT538 in Combination with Daratumumab Set for Initiation. The Phase 1 clinical trial is designed to assess three once-weekly doses of FT538 in combination with the CD38-targeted monoclonal antibody, daratumumab, for patients with relapsed / refractory multiple myeloma (NCT04614636). The Company will initiate enrollment at 100 million cells per dose upon clearance of the first dose cohort in the study’s AML regimen assessing FT538 as monotherapy.
FT576 Preclinical Data Presented at AACR (Free AACR Whitepaper) Demonstrate Super Anti-tumor Activity. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (AACR) (Free AACR Whitepaper) in April, the Company presented preclinical data for FT576 (CAR-BCMA + hnCD16 + IL-15RF + CD38KO engineered iPSC-derived NK cells), demonstrating superior in vivo persistence and anti-tumor activity as compared to cytokine-expanded primary NK cells in a disseminated xenograft model of multiple myeloma. In addition, the Company observed that multi-antigen targeting of FT576 in combination with daratumumab exhibits greater in vivo efficacy compared to primary CAR T cells in combination with a gamma secretase inhibitor. FT576 is derived from a clonal master iPSC line engineered with four functional components designed to enable multi-antigen targeting of myeloma cells, augment antibody-dependent cellular cytotoxicity (ADCC), promote NK cell activation without exogenous cytokine support, enhance cell persistence and prevent anti-CD38 monoclonal antibody-induced fratricide. The Company is preparing to initiate a multi-center Phase 1 clinical trial to assess single-dose and multi-dose treatment regimens of FT576 as monotherapy and in combination with CD38-targeted monoclonal antibody therapy for the treatment of relapsed / refractory multiple myeloma.
Solid Tumor Franchise

IND Application Allowed by FDA for FT538 in Combination with Monoclonal Antibody Therapy for Solid Tumors. The Company plans to initiate a multi-center Phase 1 clinical trial to assess the safety and determine the maximum dose of FT538 in combination with monoclonal antibody therapy for the treatment of a broad array of solid tumors. The novel therapeutic strategy is designed to exploit the product candidate’s hnCD16 receptor to promote ADCC, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. The clinical protocol includes combination with three monoclonal antibodies: EGFR-targeted cetuximab; HER2-targeted trastuzumab; and PDL1-targeted avelumab. Each patient is eligible to receive up to two FT538 treatment cycles, with each cycle consisting of three days of outpatient lympho-conditioning, three once-weekly infusions of FT538, and monoclonal antibody therapy.
Preclinical Studies of FT536 CAR MICA/B Program Demonstrate Superiority over Primary NK Cells. At AACR (Free AACR Whitepaper), the Company highlighted its development of FT536, a novel CAR NK cell product candidate targeting the alpha-3 domain of the pan-tumor associated stress antigens MICA and MICB. In preclinical studies designed to increase the density of stress antigen expression and sensitivity of tumor cells to NKG2D-mediated recognition and killing by NK cells, FT536 demonstrated superior anti-tumor activity compared to cytokine-expanded primary NK cells across a broad array of cancer cell lines. The Company plans to submit an IND application in the second half of 2021 to initiate a Phase 1 clinical trial of FT536 for the treatment of solid tumors.
Novel B7H3-targeted Binding Domain Selected for Development of iPSC-derived CAR NK Cell Program. At AACR (Free AACR Whitepaper), the Company presented preclinical data demonstrating anti-tumor activity of its novel B7H3 binding domain, including when incorporated in a tri-specific NK cell engager (TriKE), a primary CAR T cell, and an iPSC-derived CAR NK cell. B7H3 is an immune checkpoint molecule of the B7 protein superfamily with broad expression in cancer and its upregulation is associated with metastatic cancer and poor prognosis. The Company is conducting preclinical development of multiplexed-engineered, iPSC-derived CAR B7H3 NK cell and T-cell product candidates for solid tumors.
ProTmune

Phase 2 PROTECT Study Did Not Meet Primary Endpoint for Prevention of Acute GvHD. The randomized, controlled and double-blinded PROTECT study was designed to assess the safety and efficacy of ProTmune, a patient-specific hematopoietic cell graft manufactured on-site at local transplant centers using the Company’s ex vivo small molecule modulation technology, for patients undergoing allogeneic stem cell transplant. The results failed to show a statistically-significant difference between ProTmune and control with respect to the primary endpoint of cumulative incidence of Grades 2-4 acute GvHD by Day 100, and the Company is discontinuing development of ProTmune.
Other Corporate Highlights

Completed $460 Million Public Offering. In January 2021, the Company completed an underwritten public offering of 5.1 million shares of its common stock priced at $85.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 0.3 million shares of its common stock priced at $85.499 per pre-funded warrant.
First Quarter 2021 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2021 were $888.4 million. This amount includes net proceeds to the Company of approximately $432 million from the January 2021 underwritten public offering.
Total Revenue: Revenue was $11.1 million for the first quarter of 2021, which was derived from the Company’s collaborations with Janssen and Ono Pharmaceutical.
R&D Expenses: Research and development expenses were $44.9 million for the first quarter of 2021, which includes $8.5 million of non-cash stock-based compensation expense.
G&A Expenses: General and administrative expenses were $12.5 million for the first quarter of 2021, which includes $4.5 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 93.9 million, and preferred shares outstanding were 2.8 million, as of March 31, 2021. Each preferred share is convertible into five common shares.
Today’s Conference Call and Webcast

The Company will conduct a conference call today, Wednesday, May 5, 2021 at 5:00 p.m. ET to review financial and operating results for the quarter ended March 31, 2021. In order to participate in the conference call, please dial 800-708-4539 (toll free) or 847-619-6396 (toll) and refer to conference ID 50156207. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On May 5, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported financial results for the first quarter ended March 31, 2021 and provided operational highlights (Press release, Arcus Biosciences, MAY 5, 2021, View Source [SID1234579202]).

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"Our ongoing clinical trials include six randomized studies with several that are expected to provide meaningful readouts over the next 12 months," said Terry Rosen, Ph.D., CEO. "We expect the next milestone in our anti-TIGIT program, the ARC-7 interim analysis, later this quarter. We also continue to generate substantial clinical evidence to support our first-in-class therapies targeting the ATP-adenosine axis having recently presented data from ARC-3 which showed a doubling of progression-free survival and overall survival for etrumadenant and chemotherapy in late-line colorectal cancer compared to those reported for current standard-of-care therapies, and promising results for AB680 in first-line pancreatic cancer. We will present initial data from ARC-6, evaluating etrumadenant plus zimberelimab and chemotherapy in metastatic castrate-resistant prostate cancer, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting."

Anti-TIGIT Program

Domvanalimab (FcR-silent anti-TIGIT antibody)

Recent Highlights:

First patient dosed in ARC-10, Arcus’s first global registrational trial, evaluating domvanalimab + zimberelimab vs. zimberelimab vs. chemotherapy in first-line PD-L1≥50%, locally advanced or metastatic non-small cell lung cancer (NSCLC). This study is designed to seek approval for both zimberelimab monotherapy as well as domvanalimab + zimberelimab in this setting. Gilead and Arcus have been actively collaborating to define a broad clinical development program for domvanalimab, and Arcus expects to announce other registrational trials for domvanalimab later this year.
Upcoming Milestones:

Results from the interim analysis for ARC-7, a randomized, three-arm Phase 2 trial evaluating domvanalimab + zimberelimab vs. zimberelimab vs. domvanalimab + zimberelimab + etrumadenant in first-line PD-L1≥50%, locally advanced or metastatic NSCLC are expected in the second quarter of 2021. A 50% or greater ORR for the zimberelimab + domvanalimab combination and clear separation from the zimberelimab arm would be considered a positive outcome for the interim analysis by Arcus and Gilead and could inform a potential opt-in decision. We expect to present the data from this analysis at a medical conference in the second half of 2021.
AB308 (FcR-enabled anti-TIGIT antibody)

First patient dosed in the ARC-12 study evaluating AB308 in combination with zimberelimab in the second quarter of 2021. By initially evaluating AB308 in combination with an anti-PD1 antibody, this study is designed to efficiently establish the safety and optimal dose of AB308 + zimberelimab to facilitate advancement into a late-stage trial. We plan to evaluate AB308 in settings, such as certain hematological malignancies, where the depletion of TIGIT-bearing cancer cells could be beneficial.
AB680 (CD73 inhibitor)

Recent Highlights:

Completed enrollment of the dose-expansion portion and initiated the randomized portion of ARC-8, a Phase 1/1b study evaluating AB680 + zimberelimab + gemcitabine/nab-paclitaxel (G/NP) in first-line metastatic pancreatic cancer. The randomized portion includes a control arm of AB680 + G/NP to help inform the design of a potential registrational trial. Enrollment in ARC-8 has proceeded very quickly, and if data continue to look promising, we anticipate discussing these data and the path to registration with health authorities in the second half of 2021.
Evaluation of the oral formulation of AB680 in healthy volunteers demonstrated the ability to achieve the desired circulating drug levels. Having an oral formulation of AB680 provides additional dosing flexibility and the ability to combine AB680 with other orally administered therapies.
Opened a second cohort evaluating the synergistic potential of AB680 and etrumadenant. This cohort is part of our recently initiated ARC-9 metastatic colorectal cancer (mCRC) platform study. The first cohort evaluating AB680 + etrumadenant, described last quarter, is part of our ongoing ARC-6 metastatic castrate-resistant prostate cancer (mCRPC) platform study.
Upcoming Milestones:

Presentation of additional data from ARC-8, including more mature data from the dose-escalation and initial data from the dose-expansion portions of the study, at a medical conference in the second half of 2021.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

Recent Highlights:

Presented very encouraging results for ARC-3, a Phase 1/1b trial evaluating etrumadenant in combination with mFOLFOX, at the 2021 AACR (Free AACR Whitepaper) Annual Meeting. The etrumadenant combination demonstrated a 4.2 month median progression-free survival and 13.6 month median overall survival, approximately double those reported for current standard of care therapies in the ≥3L mCRC setting. These are very encouraging data in heavily pre-treated patients. In addition, the etrumadenant + mFOLFOX combination was well tolerated, and etrumadenant did not appear to add significant toxicity to that expected for mFOLFOX-6. ARC-9, our ongoing randomized Phase 1b/2 platform study evaluating etrumadenant in combination with other agents in ≥2L mCRC, builds on the encouraging data from the ARC-3 study.
Upcoming Milestones:

Presentation of initial data from the ARC-6 study in a poster at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, June 4-8th, titled: "ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study to Evaluate Efficacy and Safety of Etrumadenant (AB928)-Based Treatment Combinations in Patients with mCRPC."
Initial data from the Stage 2 randomized portion of this study are expected to be presented in early 2022.
Presentation of initial randomized data from ARC-4, an ongoing study evaluating etrumadenant + zimberelimab + chemotherapy vs. zimberelimab + chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory NSCLC, expected at a medical conference in the second half of 2021.
HIF-2α inhibitor Program

Initiation of clinical development for our HIF-2α inhibitor is anticipated to occur in the second half of 2021. At the 2021 AACR (Free AACR Whitepaper) Annual Meeting, we presented details of our Hypoxia-Inducible Factor 2α (HIF-2α) research program, including the design of a novel series of HIF-2α inhibitors, which has resulted in the identification of molecules such as AB521, with excellent potency, selectivity, biological activity and pharmacokinetic properties suitable for further development.
Financial Results for the First Quarter 2021 Ended March 31, 2021

Cash, cash equivalents and investments were $884.9 million as of March 31, 2021, compared to $735.1 million as of December 31, 2020. The increase was primarily due to gross proceeds of $220.4 million received upon the closing of the private placement of common stock under the Amended and Restated Stock Purchase Agreement with Gilead in February 2021, partially offset by cash utilized for our operations. We expect cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations at least through 2023.
Revenues: Collaboration and license revenues were $9.5 million for the three months ended March 31, 2021, compared to $1.8 million for the same period in 2020. In the three months ended March 31, 2021, we recognized $7.7 million in collaboration revenues related to Gilead’s ongoing rights to access our research and development pipeline in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement. In the three months ended March 31, 2020, we recognized $1.8 million under the Taiho Agreement.
R&D Expenses: Research and development expenses were $66.4 million for the three months ended March 31, 2021, compared to $23.1 million for the same period in 2020. The increase was primarily due to $15.0 million of sublicense and milestone expense in the 2021 period as compared to no amounts in the 2020 period. Increases in employee compensation costs, approximately $4.4 million of which consists of non-cash stock-based compensation, also contributed to the overall expense increase and were driven by increasing headcount and 2021 stock awards. Manufacturing and clinical costs increased as well due to the increased number of clinical programs and studies compared to the same quarter in the prior year. Office and facilities expense increased as we continued to grow. The overall increase in research and development expenses is partially offset by a $4.9 million reimbursement by Gilead of certain applicable costs of developing zimberelimab, including $4.0 million reimbursement related to milestone expense incurred.
G&A Expenses: General and administrative expenses were $15.8 million for the three months ended March 31, 2021, compared to $7.0 million for the same period in 2020. The increase in expense was due to increases in employee compensation, approximately $4.9 million of which consists of non-cash stock-based compensation, driven by increasing headcount and 2021 stock awards. Additional increases in finance and legal expenses were largely driven by costs incurred to support our growth and ongoing compliance with public company requirements, and we incurred additional facilities expense due to our expanding headcount and office space.
Net Loss: Net loss was $72.6 million for the three months ended March 31, 2021, compared to a net loss of $27.8 million for the same period in the prior year. The increase in net loss as compared to the same period in the prior year was primarily attributable to our expanding operations including advancements in our clinical pipeline and related milestone payments, partially offset by increased revenues due to the Gilead Collaboration Agreement.

On May 5, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that addresses a fundamental biologic mechanism of immune suppression in cancer, reported that the Company will have a presentation summarizing recent eganelisib clinical data will be followed by a Q&A session at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2021 virtual symposium taking place on May 12-14, 2021 (Press release, Infinity Pharmaceuticals, MAY 5, 2021, View Source [SID1234579218]).

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Presentation Details:

Title:
Eganelisib (IPI-549) Activity as a Macrophage Reprogramming Therapeutic Candidate in 1L Metastatic TNBC, 2L Metastatic Urothelial Cancer and Other Solid Tumors

Date:
Wednesday, May 12

Time:
1:26 pm Eastern Time

The presentation can be accessed in the Investors/Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.