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Arcus Biosciences Announces First Quarter 2018 Financial Results and Recent Corporate Updates

On May 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results and recent corporate updates for the first quarter ended March 31, 2018 (Press release, Arcus Biosciences, MAY 9, 2018, View Source [SID1234526344]).

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"The first quarter of 2018 was another exciting period for the Company, as our immuno-oncology pipeline continues to advance," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "We have submitted regulatory filings to initiate our first combination trials of AB928, our internally discovered dual adenosine receptor antagonist, with other anti-cancer agents, including our anti-PD-1 antibody, AB122, and expect to initiate dosing in patients in mid-2018. We are also on track to submit regulatory filings for our next two product candidates, AB154 and AB680, in the third quarter, and to end the year with four product candidates in clinical development."

Pipeline Updates and Upcoming Milestones

AB928 (dual A 2 R receptor antagonist)

Initiated the submission of regulatory filings for three Phase 1/1b trials to evaluate AB928 in combination with AB122 or chemotherapy. Each trial will evaluate AB928 in combination with AB122 and/or chemotherapy in selected tumor types and will be conducted in both Australia and the U.S. The trial protocols were designed to allow for the addition of other AB928 combinations over time, including triple combinations. There will be a dose-escalation portion which will be followed by dose-expansion cohorts once the recommended dose of AB928 for each combination has been selected. In both the dose-escalation portion and expansion cohorts, the Company will conduct significant biomarker analysis, designed to inform patient selection in future trials. Data from the dose-escalation portion of these trials will be presented in the first half of 2019. The three trials will evaluate AB928 combinations in the following tumor types:
— Gastrointestinal malignancies (initially colorectal and gastroesophageal cancers)
— Breast and gynecological (initially ovarian) malignancies
— Non-small cell lung cancer and renal cell carcinoma
Completed dosing in the ongoing Phase 1 double-blinded, placebo-controlled trial in healthy volunteers in April. Final results from this trial, including pharmacodynamic data for the 200 mg QD dosing cohort, are expected to be released in mid-2018.
Presented initial data from the Phase 1 trial in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data showed AB928 is safe and well tolerated at all doses evaluated (up to 200 mg QD) and achieves near complete inhibition of adenosine 2a receptor (A2aR) activation.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB928 in combination with doxorubicin or oxaliplatin results in greater immune activation and tumor control than that of chemotherapy alone in two different tumor models.
AB122 (anti-PD-1 antibody)

Initiated dosing of a third cohort in the ongoing Phase 1 dose-escalation trial in cancer patients in Australia. The Company plans to present safety, pharmacokinetic, receptor occupancy and clinical activity data from this trial in the second half of 2018.
Presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB122 is similar to nivolumab in terms of binding affinity, selectivity and anti-tumor activity in an animal model.
AB154 (anti-TIGIT antibody)

Continued to advance CMC activities and GLP toxicology studies. These studies are being conducted in preparation for the first regulatory submission for AB154 expected in mid-2018.
AB680 (small molecule CD73 inhibitor)

Presented preclinical discovery and characterization data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data demonstrated that AB680 significantly enhanced the activity of anti-PD-1 and anti-TIGIT antibodies (AB122 and AB154, respectively) in immune function assays demonstrating the potential of triple combination therapy. This drug has a predicted half-life in humans of several days, which should allow for a dosing regimen of every two or three weeks.
Preparing to submit the first regulatory filing to initiate a Phase 1 trial to evaluate AB680 in healthy volunteers. This trial, which is expected to start in the third quarter of 2018, is designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of AB680 in healthy volunteers. Clinical testing of AB680 in cancer patients is expected to begin in the first half of 2019.
Corporate Updates

The Company completed an initial public offering in March, raising approximately $124.7 million in net proceeds after deducting underwriter discounts and other offering-related costs through the sale of 9,200,000 shares of common stock at a public offering price of $15.00 per share. Proceeds from this offering are currently expected to fund the company into at least 2020.
First Quarter Financial Results:

At March 31, 2018, cash, cash equivalents and investments were $290.8 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to the receipt of $124.7 million in net proceeds from the Company’s initial public offering, which was completed in March.
Collaboration and license revenue for the first quarter ended March 31, 2018 was $1.3 million, compared to no revenue for the same period in 2017. The increase in revenue was entirely due to revenue recognized from the Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd. in September 2017.
Research and development expenses for the first quarter ended March 31, 2018 were $11.7 million, compared to $5.8 million for the same period in 2017. The increase of $5.9 million was primarily due to an increase in manufacturing and clinical costs to support our ongoing AB928 and AB122 clinical trials and an increase in R&D headcount to support the Company’s other programs.
General and administrative expenses for the first quarter ended March 31, 2018 were $2.9 million, compared to $1.5 million for the same period in 2017. The increase of $1.4 million was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased facilities and office expenses related to our expanded facility in Hayward.
Net loss for the first quarter ended March 31, 2018 was $13.0 million, compared to $7.2 million for the same period in 2017. The increase in net loss was primarily attributable to the increase in operating expenses noted above.

Aileron Therapeutics Reports First Quarter 2018 Financial Results

On May 9, 2018 Aileron Therapeutics (Nasdaq:ALRN), the clinical-stage leader in the field of stapled peptide therapeutics for cancers and other diseases, reported business highlights and financial results for the first quarter ended March 31, 2018 (Press release, Aileron Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348220 [SID1234526343]).

"In the first quarter, we continued to advance our clinical and non-clinical stapled peptide programs as we pursue our mission to provide transformational outcomes for patients with life-threatening diseases," said Joseph A. Yanchik III, President and Chief Executive Officer of Aileron. "The clinical activity and safety seen in our interim data from our ongoing Phase 2a clinical trial of ALRN-6924, in addition to our Phase 1 data, continue to support the clinical importance of p53 and the potential of ALRN-6924 in solid and liquid tumors where there is significant need for new treatment options. In addition, our research team continues to make progress in evaluating ALRN-6924 for development in combination studies, and to identify new targets and disease indications for clinical development."

ALRN-6924 Program Highlights

Enrollment Ongoing in Phase 2a Trial with ALRN-6924 in Peripheral T-Cell Lymphoma
ALRN-6924 is a first-in-class stapled peptide designed to reactivate wild-type p53 tumor suppression in solid and liquid tumors. Aileron is conducting a Phase 2a open-label, multi-center trial of ALRN-6924 as a monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company believes that the preliminary overall response rate observed in the trial (as of February 26, 2018) is generally in line with the reported overall response rates for Romidepsin, the 2nd line PTCL market share leader. Given that ALRN-6924 continues to be well-tolerated, the Company is enrolling patients in an expansion cohort to determine if more frequent dosing can provide an increased benefit to certain patients. Aileron expects to report additional interim data from this trial in the second half of this year.

Company Continues to Advance Phase 1 and 1b Studies in AML and MDS
Aileron is conducting Phase 1 and 1b open-label, multi-center clinical trials of ALRN-6924 as a monotherapy and in combination with cytosine arabinoside (Ara-C) for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The dose escalation studies are designed to establish the recommended Phase 2 dose of ALRN-6924 in patients with AML or MDS, and to evaluate its safety and to provide a preliminary assessment of anti-leukemic activity. In an interim cut of the data (as of February 26, 2018), the Company has observed encouraging evidence of clinical activity and a safety profile consistent with earlier studies. Aileron expects to report interim data from these trials, its dosing strategy, and its plans for a Phase 2 trial in the second half of this year.

Company Expands Non-Clinical Studies of ALRN-6924 Combinations
Based on ALRN-6924’s unique mechanism of action and safety profile, Aileron has expanded its non-clinical research to test a variety of approved drugs in combination with ALRN-6924, including immuno-oncology agents, cyclin-dependent kinase inhibitors and traditional chemotherapeutic agents for solid and liquid tumors. Aileron expects to provide an update on its non-clinical data and development plans for its combination studies during the second half of 2018.
Interim Data Review of Phase 1 All Comers Trial Demonstrates ALRN-6924 Potential
In April, Aileron provided interim data (as of February 26, 2018) from the 63 evaluable patients in the Phase 1 dose escalation trial of ALRN-6924 in patients with advanced solid tumors and lymphomas. As of the February 26th cut-off date, five patients, including two patients who achieved complete responses (CR) and one patient who achieved a partial response (PR), remain on treatment for an average treatment period of 685 days. This trial tested nine dose levels and two dosing regimens of once and twice weekly. Of the 63 evaluable patients, 30 patients, or 48%, demonstrated disease control. This included two CRs, two PRs, and 26 with stable disease, with 42% of stable disease patients showing tumor shrinkage. In a subset of 41 patients whose cells did not contain mutated p53 and received a minimum dose of ALRN-6924, 24 patients (59%) demonstrated disease control, consisting of two CRs, two PRs, and 20 with stable disease.
ALRN-6924 Non-Clinical Results Published in Science Translational Medicine
In April, Science Translational Medicine published non-clinical results demonstrating the anti-cancer potential of ALRN-6924 in models of AML. Conducted by researchers at Albert Einstein College of Medicine, the studies showed that treatment with ALRN-6924 increased the median survival rate in an animal model of human AML (mice transplanted with human leukemia cells) from 50 to approximately 150 days. In addition, about 40% of the animals were cured, meaning they were tumor-free at one year.
Corporate Updates

Aileron Expands Scientific Advisory Board
In March, Aileron expanded its Scientific Advisory Board with the additions of preeminent scientists Dr. Brian Druker (Knight Cancer Institute, Oregon Health & Science University), Dr. Alan List (Moffitt Cancer Center), and Dr. Carol Prives (Columbia University), all of whom have made groundbreaking contributions to the development of novel cancer therapies.
Company to Present at Upcoming Conferences
The Company plans to participate at upcoming investor conferences, including the Bank of America Merrill Lynch 2018 Health Care Conference (May 15-17, Las Vegas), the Jefferies Global Healthcare Conference (June 5-8, NYC), and the Canaccord Genuity 38th Annual Growth Conference (Aug. 8-9, Boston).
First Quarter 2018 Financial Results

Cash Position and Guidance: Cash, cash equivalents and investments as of March 31, 2018 were $43.3 million, compared to $50.8 million as of December 31, 2017. The Company believes that its cash, cash equivalents and investments as of March 31, 2018 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2019.
R&D Expenses: Research and development (R&D) expenses were $4.8 million for Q1 2018, compared to $2.9 million for the same period in 2017. The increase in R&D expense was primarily driven by increased activity in the Company’s non-clinical research and increases in clinical and non-clinical personnel expense. Higher costs were attributable to research associated with expanded testing of a variety of approved drugs in combination with ALRN-6924 along with higher expenses as a result of hiring additional personnel to support ongoing clinical and non-clinical research programs. The Company expects R&D expenses to continue to increase as it continues to advance its ALRN-6924 program and hires additional R&D personnel.
G&A Expenses: General and administrative (G&A) expenses were $2.9 million in Q1 2018, compared to $1.6 million for the same period in 2017. The increase in G&A was primarily due to new hires, increases in non-cash stock compensation costs, and professional fees related to the increased cost of being a public company, consisting mostly of legal and accounting fees. The Company expects G&A expenses to continue to increase as it hires additional personnel to support the Company’s anticipated growth in its research and development activities and incurs increased expenses associated with being a public company.

Net Loss: The Company reported a net loss attributable to common stockholders of $7.6 million in Q1 2018 compared to $4.6 million for the same period in 2017. Based on the Company’s weighted average shares outstanding, the Company reported a net loss attributable to common stockholders of $0.52 per share in Q1 2018, compared to $10.58 per share for the same period in 2017.
Non-GAAP net loss attributable to common stockholders for Q1 2017 was $0.42 based on non-GAAP weighted-average common shares outstanding of 10.9 million shares. The non-GAAP weighted-average shares outstanding gives effect to the conversion of all outstanding shares of redeemable convertible preferred stock to common stock, as if such conversion had occurred at the beginning of the period.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the table included below in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Shares Outstanding: As of March 31, 2018, there were 14.7 million shares of common stock outstanding.

About ALRN-6924
ALRN-6924 is a first-in-class product candidate designed to reactivate wild type p53 tumor suppression by disrupting the interactions between the two primary p53 suppressor proteins, MDMX and MDM2. Aileron believes ALRN-6924 is the first and only product candidate in clinical development that can equipotently bind to and disrupt the interaction of MDMX and MDM2 with p53. Based on preclinical data and preliminary evidence of safety and anti-tumor activity in its ongoing clinical trials, there may be a significant opportunity to develop ALRN-6924 as a monotherapy or combination therapy for a wide variety of solid and liquid tumors. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma (PTCL). For information about its clinical trials, please visit www.clinicaltrials.gov.

Adaptimmune Reports First Quarter 2018 Financial Results and Business Update

On May 9, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2018, as well as provided a business update (Press release, Adaptimmune, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348055 [SID1234526342]).

"2018 is off to an outstanding start, and the remainder of the year promises to be even more exciting for Adaptimmune as we look forward to response data from our wholly owned assets in a variety of solid tumors," commented James Noble, Adaptimmune’s Chief Executive Officer. "The transition of the NY-ESO program to GSK is progressing, our manufacturing capabilities are strengthening, and we have a robust pipeline delivering novel therapeutic approaches to cancer patients. We look forward to presenting further progress in the coming months as we move towards our ambition to be the first to market with an approved TCR T-cell therapy."

Clinical momentum
Adaptimmune continues to make good progress across all trial cohorts. Clinical data highlights include:

Initial safety data (https://bit.ly/2HAuhTS) with Adaptimmune’s wholly owned SPEAR T-cell therapy targeting MAGE-A10 reported in January. These data will be presented and updated in a poster at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June.
Dosing at the target dose of one billion transduced SPEAR T-cells in the MAGE-A10 triple tumor study reported in January (https://bit.ly/2HAuhTS).
Dosing at the target dose of one billion transduced SPEAR T-cells after recent recommendation from the scientific review committee (SRC) to dose escalate in the MAGE-A10 non-small cell lung cancer (NSCLC) study.
Responses in a second solid tumor, myxoid round/cell liposarcoma (MRCLS), with NY-ESO reported in March (https://bit.ly/2HAluxz). These data will be presented and updated at an oral presentation during ASCO (Free ASCO Whitepaper).
Initial safety data from the MAGE-A4 "basket study" (required to support dose escalation to one billion cells) is on track for the second quarter of 2018. MAGE-A4 response data and initial AFP safety data are anticipated throughout the second half of this year.

Manufacturing progress
In another important step towards its ambition to become a fully integrated cell therapy company, Adaptimmune has now received regulatory approval to produce SPEAR T-cells for all of its wholly owned programs (MAGE‑A10, MAGE-A4, and AFP) at its Philadelphia Navy Yard facility. The Company is routinely manufacturing SPEAR T-cells at the Navy Yard, and achieving cell volumes in the range of the therapeutic doses seen with NY‑ESO in synovial sarcoma.

In addition, Adaptimmune announced in January 2018 (https://bit.ly/2D8A52t ) that it had executed an agreement with Cell and Gene Therapy (CGT) Catapult for its own dedicated manufacturing space to secure vector supply for the medium term for ongoing studies with all three wholly owned SPEAR T-cell therapies. The Catapult space is now officially open.

Highlights

Wholly owned programs

Continued momentum towards safety and response readouts from SPEAR T-cells targeting MAGE-A10 and MAGE-A4 in multiple solid tumors throughout the second half of 2018, and initial safety data from AFP in hepatocellular carcinoma anticipated in late 2018

MAGE-A10
– Dosing at one billion target cell dose in both pilot studies (NSCLC and "triple tumor")
– To date, no evidence of off-target toxicity in MAGE-A10 pilot studies in patients who received 100 million cells
– Response data anticipated in the second half of 2018
– Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2018 support the potential specificity and potency of Adaptimmune’s MAGE‑A10 SPEAR T-cells (https://bit.ly/2HulQJG)
MAGE-A4
– Basket study: Dosing continues and on schedule to report initial safety data in Q2 2018
– Response data are anticipated throughout the second half of this year
– Preclinical safety data presented at AACR (Free AACR Whitepaper) identified no major safety concerns for MAGE-A4 SPEAR T‑cell, and analyses of NSCLC tumor samples support the validity of MAGE‑A4 as a target in this indication (https://bit.ly/2HulQJG)
AFP
– Hepatocellular carcinoma: Study open and enrolling with initial safety data anticipated in late 2018

Next generation SPEAR T-cells
– Adaptimmune’s US patent US15/713464 covering a "next generation" approach to making our T‑cells resistant to the immunosuppressive environment of solid tumors, has been granted. This approach is likely to be used in some of the Company’s future clinical trials.
NY-ESO program (partnered with GSK)
Compelling clinical data supports the potential of Adaptimmune’s TCR T-cell therapies to treat solid tumors

MRCLS: Update will be presented in an oral presentation at ASCO (Free ASCO Whitepaper).
GSK option exercise and transition: The transition of the NY-ESO program to GSK is ongoing.
Manufacturing
Adaptimmune is building a fully integrated cell therapy company

Received regulatory approval to produce SPEAR T-cells for all of its wholly owned programs (MAGE-A10, MAGE-A4, and AFP) at its Philadelphia Navy Yard facility.
Routinely manufacturing SPEAR T-cells at the Navy Yard, and achieving cell volumes in the range of the therapeutic doses seen with NY ESO in synovial sarcoma.
Announced in January 2018 (https://bit.ly/2D8A52t ) that it had executed an agreement with CGT Catapult for its own dedicated manufacturing space to secure vector supply for the medium term for ongoing studies with all three wholly owned SPEAR T-cell therapies.
The Catapult space is now officially open.
Had a US patent granted (US9932597), covering a "WPRE-free" vector system, that will further optimize the vector system used for manufacture of its SPEAR T-cells.
Other corporate news
Adaptimmune is in a strong financial position to deliver success with SPEAR T-cell therapies

Funded through to early 2020 with cash and cash equivalents of $53.4 million and total liquidity1 of $161.8 million
Announced in April 2018 (https://bit.ly/2v7v3D3 ) that John Furey, Chief Operating Officer at Spark Therapeutics, was appointed as an independent Non‑Executive Director to Adaptimmune’s Board of Directors (effective July 5, 2018)
Financial Results for the three-month period ended March 31, 2018

Cash / liquidity position: As of March 31, 2018, Adaptimmune had cash and cash equivalents of $53.4 million and Total Liquidity1 of $161.8 million that will fund the Company through early 2020 based on management’s estimates.
Revenue: With effect from January 1, 2018, the Company has adopted a new accounting standard2. Under this new accounting standard, revenue represents the upfront payment and milestones under the GSK Collaboration and License Agreement, which are recognized based on the percentage completion of the NY-ESO and PRAME development programs. Revenue for the three months ended March 31, 2018 was $8.2 million. Revenue for the three months ended March 31, 2018 under the previous guidance would have been $9.0 million, compared to $2.9 million for the same period of 2017. This increase in revenue, compared to the same period in 2017, is primarily due to a reduction in the period over which the Company is recognizing revenue following GSK’s exercise of its option over the NY-ESO program in September 2017 and additional development milestones achieved.
Research and development ("R&D") expenses: R&D expenses for the three months ended March 31, 2018 were $25.7 million, compared to $18.6 million for the same period of 2017. The increase was primarily due to increased costs associated with clinical trials, manufacturing for clinical trials, and increased personnel costs.
General and administrative ("G&A") expenses: G&A expenses for the three months ended March 31, 2018 were $11.2 million, compared to $6.5 million for the same period of 2017. The increase was primarily due to increased personnel costs consistent with the Company’s planned growth, an increase in costs associated with developing its IT infrastructure and an increase in other corporate costs.
Other income, net: Other income for the three months ended March 31, 2018 was $7.1 million, compared to $0.4 million for the same period of 2017. Other income primarily comprises unrealized foreign exchange gains, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended March 31, 2018 was $21.1 million ($(0.04) per ordinary share) compared to $21.8 million ($(0.05) per ordinary share) in the same period of 2017.
Financial guidance
The Company believes that its existing cash, cash equivalents, marketable securities and income from GSK upon transition of the NY-ESO program will fund the Company’s current operating plan through to early 2020.

_________________________________________
1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.
2 ASC 606, Revenue from Contracts with Customers.

Conference call information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, May 9, 2018. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial 1-833-652-5917 (U.S.) or 1-430-775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2967789).

Tetraphase Pharmaceuticals to Present at the UBS Global Healthcare Conference

On May 9, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant infections, reported that its corporate presentation will be webcast live at the UBS Global Healthcare Conference on Monday, May 21 at 1:00 p.m. Eastern Time at the Grant Hyatt New York in New York City (Press release, Tetraphase, MAY 9, 2018, View Source [SID1234526321]). Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

Spectrum Pharmaceuticals to Present Corporate Update at the Bank of America Merrill Lynch 2018 Health Care Conference on May 16th

On May 9, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that an overview of the company’s business strategy and commercial and development-stage programs will be given at the Bank of America Merrill Lynch 2018 Health Care Conference being held at the Encore Hotel in Las Vegas, Nevada (Press release, Spectrum Pharmaceuticals, MAY 9, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-bank-america-3 [SID1234526320]). The company presentation is on Wednesday, May 16, 2018, at 8:55 AM PDT.

A live webcast of Spectrum’s presentation will be available at View Source