On November 6, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported financial results for the fiscal quarter ended September 30, 2018 (Press release, Five Prime Therapeutics, NOV 6, 2018, View Source [SID1234530939]).

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"With five programs in the clinic, we and our partners are advancing drug candidates to target multiple immune cell types in the tumor microenvironment, focusing on drugs that demonstrate single-agent activity or activity in tumor types that have been insensitive to checkpoint inhibitors," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "Since our last earnings call, we dosed the first patient in our Phase 3 FIGHT pivotal trial of bemarituzumab in gastric and GEJ cancer. BMS also continues to advance the randomized Phase 2 clinical trial evaluating cabiralizumab and OPDIVO in patients with advanced pancreatic cancer."

Mr. Knickerbocker continued, "In addition, FPA150, our first-in-class B7-H4 antibody, is generating strong interest from investigators, and we are ahead of schedule in initiating our dose exploration basket cohort in patients whose tumors overexpress B7-H4. Additionally, we are screening patients in Australia for our Phase 1 clinical trial of FPT155, our first-in-class CD80 fusion protein. FPT155 induces strong single-agent activity in multiple preclinical models, and we look forward to evaluating this drug in various tumor settings."

Third Quarter 2018 Business Highlights and Recent Developments

Clinical Pipeline:

Bemarituzumab (FPA144): A first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

Five Prime initiated patient dosing in the randomized, controlled Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial (NCT03694522).
The FIGHT trial is designed to evaluate 15 mg/kg of bemarituzumab in combination with mFOLFOX6 against placebo in combination with mFOLFOX6 in approximately 550 patients with advanced gastric or GEJ cancer.
Five Prime plans to conduct the FIGHT trial at over 200 clinical trial sites in North America, Europe and Asia. In China, Five Prime is conducting the trial in collaboration with Zai Lab.
Five Prime is using immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with FGFR2b-overexpressing gastric and GEJ cancer who would be eligible for the trial.
An abstract featuring data on bemarituzumab in combination with mFOLFOX6 from the Phase 1 safety lead-in (NCT03343301) has been accepted as a poster presentation at the ASCO (Free ASCO Whitepaper) GI conference in January.
Cabiralizumab (FPA008): An antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.

Bristol-Myers Squibb Company (BMS) is currently enrolling patients in a randomized, open-label, multi-arm Phase 2 clinical trial to determine the efficacy of cabiralizumab in combination with OPDIVO (nivolumab), with and without chemotherapy, as a second-line treatment for patients with pancreatic cancer (NCT03336216). BMS plans to enroll approximately 160 pancreatic cancer patients from the United States, Canada, Europe, Japan, Korea and Taiwan, each of whom will be randomized to one of four study arms based on the patient’s prior therapy.
Stand Up To Cancer and BMS are supporting the study titled Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial) (NCT03697564). This is a randomized Phase 2 front-line maintenance trial to determine whether the combination of gemcitabine with cabiralizumab and OPDIVO can provide prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone.
Apexigen, Inc. and BMS continue to support a Phase 1/1b clinical trial to evaluate APX005M (anti-CD40) in combination with cabiralizumab and OPDIVO (NCT03502330). The expansion portion of the trial will study the triple drug combination in patients with melanoma, non-small cell lung cancer or renal cell carcinoma whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor without intervening therapy.
FPA150 (anti-B7-H4): A first-in-class anti-B7-H4 antibody designed to target tumor cells through two mechanisms of action: (i) by blocking B7-H4 from sending an inhibitory signal to CD8 T cells and (ii) by enhancing killing of B7-H4 overexpressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

In October 2018, Five Prime initiated an exploratory cohort to investigate FPA150 monotherapy in patients with tumors that overexpress B7-H4 at a dose predicted to be active based on preclinical data. Five Prime plans to enroll up to 10 patients whose tumors overexpress B7-H4 in this exploratory cohort to evaluate potential preliminary clinical activity of FPA150.
The exploratory cohort is part of an ongoing Phase 1a/1b clinical trial of FPA150 (NCT03514121) in multiple cancers. The Phase 1a dose escalation portion of the trial is evaluating FPA150 monotherapy in advanced solid tumors. Five Prime is advancing through dose escalation and is currently evaluating the seventh of eight expected dose levels.
After completing the Phase 1a dose escalation portion of the trial, Five Prime plans to select a dose and initiate the Phase 1b expansion portion of the trial to evaluate FPA150 monotherapy in disease-specific cohorts of patients whose tumors overexpress B7-H4, initially in HR+/HER2- and triple-negative breast cancers, ovarian cancer and endometrial cancer.
Five Prime anticipates presenting Phase 1 data at a medical conference in 2019.
FPT155 (CD80-Fc): A first-in-class CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and (ii) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

Studies in preclinical models suggest FPT155 has the potential to be a potent T cell co-stimulator with strong monotherapy antitumor activity and may have a synergistic effect when combined with anti-PD1 therapy.
Five Prime is conducting a Phase 1a/1b clinical trial of FPT155 in Australia in patients with solid tumors. The objectives of this trial are to gain data on safety, pharmacokinetics and potential preliminary single-agent activity of FPT155. In October 2018, the company opened enrollment in the Phase 1a dose escalation portion of the trial.
BMS-986258 (anti-TIM-3): A fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T cell responses.

BMS is conducting a Phase 1/2 clinical trial to evaluate BMS-986258 as a single agent and in combination with each of OPDIVO and Halozyme’s rHuPH20 (recombinant human hyaluronidase, PH20) enzyme in patients with advanced malignant tumors (NCT03446040).
BMS-986258 is the first clinical candidate from BMS’s immuno-oncology research collaboration with Five Prime.
BMS’s poster #P684 titled "Preclinical Studies of TIM-3 Blockade Supporting Clinical Development of BMS-986258, an Anti‒TIM-3 Monoclonal Antibody" will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November.
Corporate

Five Prime announced David V. Smith will join as Executive Vice President and Chief Financial Officer on November 26.
Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $321.6 million as of September 30, 2018, compared to $292.7 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to $107.6 million in net proceeds from the January 2018 public offering of common stock and $34.5 million in milestone and upfront payments Five Prime received from collaboration partners, net of cash used by Five Prime in operations to advance its clinical stage programs as well as preclinical research and development.
Revenue. Collaboration and license revenue for the third quarter of 2018 decreased by $2.5 million, or 30%, to $5.8 million from $8.3 million for the third quarter of 2017. This decrease was primarily due to decreased revenue recognized under the cabiralizumab collaboration with BMS and the fibrosis and CNS collaboration with UCB, offset by the collaboration and license revenue from Five Prime’s China collaboration with Zai Lab executed in December 2017.
R&D Expenses. Research and development expenses for the third quarter of 2018 increased by $2.0 million, or 5%, to $44.7 million from $42.7 million in the third quarter of 2017. This increase was primarily related to milestone payments triggered by the dosing of the first patient in the Phase 3 FIGHT trial and increased clinical expenses to advance Five Prime’s development programs and employee compensation, offset by decreased spending on preclinical programs.
G&A Expenses. General and administrative expenses for the third quarter of 2018 increased by $0.1 million, or 1%, to $9.8 million from $9.7 million in the third quarter of 2017. This was primarily due to increased patent, legal and consulting expenses, offset by reduced personnel and other miscellaneous costs.
Net Loss. Net loss for the third quarter of 2018 was $47.2 million, or $1.37 per basic and diluted share, compared to a net loss of $43.3 million, or $1.54 per basic and diluted share, for the third quarter of 2017.
Shares Outstanding. Total shares outstanding were 34.5 million as of September 30, 2018.
Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. Five Prime has revised its guidance and now estimates ending 2018 with approximately $265 million in cash, cash equivalents and marketable securities, an increase from its previous guidance of approximately $250 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 6489275. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On November 6, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results for the third quarter ended September 30, 2018 and provided updates on its clinical and preclinical programs (Press release, Arcus Biosciences, NOV 6, 2018, View Source [SID1234531019]).

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"This was another productive quarter for Arcus as we began dosing patients with our third product candidate, AB154, and made significant progress advancing our initial combination trials for AB928," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "The starting dose for the dose-escalation portion of our AB928 combination trials is 75 mg once-daily, a dose that demonstrated significant inhibition of the adenosine 2a receptor pathway in our healthy volunteer study. We have incorporated extensive biomarker analysis into the design of our AB928 combination trials to determine if clinical responses observed in the trials can be attributed to the mechanism of action of AB928. We look forward to reporting initial clinical data for both AB928 and AB154, as well as data from our healthy volunteer study of AB680, our small-molecule CD73 inhibitor, in 2019."

Pipeline Updates and Poster Presentations

AB928 (dual A2aR/A2bR antagonist)

Initiated the first three AB928 combination trials in patients. AB928 is being evaluated in combination with other agents in the following Phase 1/1b dose-escalation trials, which are now enrolling patients:

AB928 in combination with Doxil in triple negative breast (TNBC) and ovarian cancers

AB928 in combination with mFOLFOX in colorectal and gastroesophageal cancers

AB928 in combination with AB122, the Company’s anti-PD-1 antibody, in advanced solid tumor types

The Company also expects the following AB928 dose-escalation trial to be open for enrollment shortly:

AB928 in combination with carboplatin/pemetrexed and pembrolizumab in non-small cell lung cancer (NSCLC)

In the above NSCLC trial, the Company also plans to explore AB928 combinations in the relapsed/refractory setting, including in patients previously treated with anti-PD-1 therapy.

Six posters to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 Annual Meeting taking place November 7th through 11th:

"Development of biomarkers to assess adenosine generation & activity in support of clinical trials conducted with the adenosine receptor antagonist AB928" will highlight the development of biomarkers to enable the selection of patients and tumor types with the highest levels of CD73, the rate-limiting enzyme responsible for the production of adenosine.

"Selection of optimized drug candidates, dosing regimen, pharmacodynamic endpoints, tumor types, and biomarkers for translating inhibition of the adenosine pathway into effective anti-tumor activity" will highlight the Company’s strategy for identifying the optimal tumor types to target for each of AB928 and AB680.

Four "Trial in Progress" poster presentations will summarize the design of the Company’s four AB928 combination trials.

Presented final results from the Phase 1 double-blinded, randomized, placebo-controlled trial of AB928 in healthy volunteers in a poster presentation at ESMO (Free ESMO Whitepaper) in October. Data presented in this poster presentation support the selection of the starting dose of AB928 for clinical trials in patients.

Presented a poster on the ability of AB928 to relieve adenosine-mediated immune suppression at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. The in vitro data presented demonstrate that AB928 prevents adenosine-mediated gene expression changes and suppression of immune cell function and suppresses tumor growth in syngeneic mouse models when administered as a monotherapy or in combination with anti-PD-1 or chemotherapy.

AB122 (anti-PD-1 antibody)

Two posters to be presented at the SITC (Free SITC Whitepaper) 2018 Annual Meeting in November:

"Preliminary results from an ongoing Phase 1 study of AB122 in patients with advanced solid tumors" will include pharmacokinetic, receptor occupancy, safety and clinical activity data from the Phase 1 dose-escalation trial for AB122.

"Development of a robust, simplified method to measure receptor occupancy in peripheral blood from patients treated with a novel anti-PD-1 agent, AB122" will demonstrate, together with the previous poster, that AB122 achieved significant inhibition of PD-1 in patients treated in the first two dosing cohorts of the Phase 1 dose-escalation trial.

Continued dosing patients in the Company’s Phase 1 dose-escalation trial for AB122. As of November 3, 2018, the Company had dosed 20 patients with AB122 evaluating different doses and dosing schedules. Based on data generated to date, the Company selected 240 mg as the dose for the Q2W (every 2 weeks) regimen for AB122.

AB154 (anti-TIGIT antibody)

Dosed the first cohort of patients in the dose-escalation portion of the ongoing Phase 1 trial for AB154 in Australia. This Phase 1 trial is evaluating AB154 in selected solid tumor types. The dose-escalation portion will be followed by the initiation of expansion cohorts in tumor types associated with high levels of TIGIT and/or CD155, the ligand for TIGIT, once the recommended doses for

AB154 as a monotherapy and in combination with AB122 have been identified. The Company plans to file an Investigational New Drug (IND) Application for AB154 in the U.S. by the end of the first quarter of 2019.

Presented a poster on the preclinical characterization of AB154 at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. Data presented demonstrated that AB154 enhances the T cell activation effects of our anti-PD-1 antibody (AB122) in a mixed lymphocyte assay and that AB154 has sub-nanomolar potency on peripheral blood lymphocytes derived from both healthy donors and NSCLC patients.

Presented a poster at the SITC (Free SITC Whitepaper) 2018 Annual Meeting in November:

"Preclinical characterization of AB154, a fully humanized α-TIGIT antibody, for use in combination therapies" will highlight the Company’s development of a TIGIT occupancy assay, which is being implemented in the ongoing Phase 1 trial of AB154.

AB680 (small molecule CD73 inhibitor)

Received regulatory approval in Australia to initiate a healthy volunteer trial for AB680 (IV formulation). This trial is primarily designed to determine the safety, tolerability and pharmacokinetic profile of AB680 prior to initiating clinical testing of AB680 in cancer patients and is expected to begin dosing shortly. Preclinical data suggest that the half-life of AB680 should be sufficient for clinical dosing every two or three weeks.

Presented a poster on the preclinical pharmacokinetic and pharmacodynamic characterization of AB680 at the Fourth AACR (Free AACR Whitepaper) International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. Data presented demonstrated that AB680 is a highly potent and selective small-molecule inhibitor of CD73 and that AB680 has a long projected human half-life.

IND-enabling studies for an oral formulation of AB680 are ongoing.

Corporate Updates

In October, Arcus announced that Kristin M. Hege, M.D., was appointed to its Board of Directors. Dr. Hege currently serves as Corporate Vice President, Translational Development, Hematology and Oncology and San Francisco site head at Celgene.

Upcoming Milestones

In the first half of 2019, the Company expects to:

Present initial data from the dose-escalation portion of the AB928 Phase 1/1b combination trials, which will include data on safety, biomarker analysis and clinical activity for the combinations, in the second quarter.

Initiate an expansion cohort to evaluate AB122 as a monotherapy to confirm that the activity of AB122 is similar to that of the approved anti-PD-1 antibodies.

Report safety and pharmacokinetic data from the Phase 1 trial of AB680 in healthy volunteers, and initiate the Phase 1 clinical program for AB680 in cancer patients.

In the middle of 2019, the Company expects to:

Initiate the first of the expansion cohorts for the AB928 combination trials.

In the second half of 2019, the Company expects to:

Present additional data from the dose-escalation portion of the AB928 Phase 1/1b combination trials.

Present initial data from the ongoing Phase 1 trial of AB154.

Third Quarter and Year-to-Date 2018 Financial Results

Cash Position: At September 30, 2018, cash and investments (which include cash equivalents and both short-term and long-term investments) were $265.6 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to $124.7 million in net proceeds from the Company’s initial public offering in March.

Revenues: Collaboration and license revenues for the third quarter ended September 30, 2018 were $4.3 million, compared to $0.2 million for the same period in 2017. Collaboration and license revenues for the nine months ended September 30, 2018 were $6.8 million, compared to $0.2 million for the same period in 2017. The increase in revenues for both periods was attributable to revenues recognized from the Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd in September 2017.

R&D Expenses: Research and development expenses for the third quarter ended September 30, 2018 were $12.9 million, compared to $21.4 million for the same period in 2017. The decrease was due to licensing costs of $15.0 million paid to WuXi Biologics in the third quarter ended September 30, 2017, partially offset by an increase in clinical and manufacturing costs related to the Company’s initiation of its AB928 combination and AB154 clinical trials, preclinical and manufacturing costs to prepare AB680 for clinical trials, an increase in R&D headcount to support the Company’s clinical operations and other programs, and an increase in lab supplies. Research and development expenses for the nine months ended September 30, 2018 were $38.2 million, compared to $35.1 million for the same period in 2017.

G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2018 were $3.6 million, compared to $1.9 million for the same period in 2017. The increase 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. General and administrative expenses for the nine months ended September 30, 2018 were $10.0 million, compared to $5.2 million for the same period of 2017.

Net Loss: Net loss for the third quarter ended September 30, 2018 was $10.8 million, compared to $23.1 million for the same period in 2017. The decrease in net loss was primarily attributable to the increase in revenue and changes in operating expenses noted above. Net loss for the nine months ended September 30, 2018 was $37.3 million, compared to $39.9 million for the same period in 2017.

Based on its current operating plan, the Company expects that its cash and investments as of September 30, 2018 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into 2021.

On November 6, 2018 Nordic Nanovector ASA (OSE: NANO) reported its third quarter 2018 results (Press release, Nordic Nanovector, NOV 6, 2018, View Source [SID1234553487]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Eduardo Bravo, CEO, commented: "The latest updated clinical results from a once-only administration of Betalutin, to be presented at ASH (Free ASH Whitepaper) in December, highlight the very promising clinical profiles of the two dosing regimens that are being evaluated in patients with relapsed/refractory indolent NHL. We are working hard to advance the PARADIGME study to confirm these results in a trial with 130 patients and to enable the selection of the best dosing regimen for our regulatory submissions. We are also pleased that Betalutin has received PIM designation in the UK reflecting the high unmet medical need of the FL patient population as well as the potential of Betalutin to offer therapeutic benefits to these patients. Both the PIM and Fast Track designations (granted by the FDA in June) provide opportunities for enhanced dialogue with health authorities and a route to bring Betalutin to patients quicker. We have a clear focus on delivering results from PARADIGME in 1H 2020 and in building further value in Nordic Nanovector from our CD37-targeting approach to treating patients with NHL."

Operational Highlights
• Abstract reporting promising clinical results from LYMRIT 37-01 trial with Betalutin published ahead of poster presentation at ASH (Free ASH Whitepaper)
o Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin) in relapsed/refractory follicular lymphoma patients
o Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)
o Well tolerated with predictable and manageable safety profile

• Site activations and patient recruitment progressing for pivotal Phase 2b PARADIGME trial
o As of 5 November, 51 (of 80-85) sites in 16 (of 20) countries are open for enrolment
o First US site in Long Beach, CA open for enrolment

Betalutin granted Promising Innovative Medicine (PIM) Designation in the UK for the treatment of advanced relapsed/refractory FL

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients

• Promising results from a collaborative R&D project to develop a CD37-targeted alpha therapy published in abstract ahead of ASH (Free ASH Whitepaper) presentation
o Next-generation targeted alpha therapy comprises Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) linked to lead-212 for treating B-cell malignancies

Financial Highlights Third Quarter 2018

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the third quarter amounted to NOK 0 (NOK 0.1 million).

• Total operating expenses for the third quarter were NOK 76.9 million (NOK 72.7 million). Total operating expenses for the first nine months of 2018 amounted to NOK 243.7 million (NOK 214.9 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 73.0 % of total operating expenses (71.0 %) for the first nine months of 2018.

• Comprehensive loss for the third quarter amounted to NOK 75.4 million (loss of NOK 85.9 million). Comprehensive loss for the first nine months of 2018 was NOK 249.1 million (loss of NOK 207.9 million)

• Cash and cash equivalents amounted to NOK 499.7 million at the end of September 2018 (NOK 570.1 million at 30 June 2018 and NOK 756.6 million at 31 December 2017)

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin has been granted Fast Track and PIM designations in the US and UK, respectively, for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, NHL and other haematological cancer indications.
The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.

Third Quarter 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: HOLMENKOLLEN

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.

On November 6, 2018 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the third quarter ended September 30, 2018 and raised its full year 2018 revenue guidance (Press release, Vericel, NOV 6, 2018, View Source [SID1234530758]).
Third Quarter 2018 Financial Highlights

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Total net revenues increased 58% to $22.5 million compared to $14.3 million in the third quarter of 2017;

Gross margins of 64% compared to gross margins of 50% in the third quarter of 2017;

Net loss of $1.1 million, or $0.02 loss per share, compared to net loss of $5.4 million, or $0.16 per share, in the third quarter of 2017;

Non-GAAP adjusted EBITDA of $0.9 million compared to a loss of $2.9 million in the third quarter of 2017;

As of September 30, 2018, the company had $97.8 million in cash and short-term investments compared to $26.9 million in cash at December 31, 2017; and

Full year 2018 revenue guidance raised to $87 to $90 million compared to previous full year revenue guidance of $80 to $83 million.

Recent Business Highlights
During and since the third quarter of 2018, the company:

Reported record third quarter revenues, marking the sixth consecutive quarter with record revenues for the reported quarter;

Announced plans to increase the MACI sales force by 20%, adding a sixth sales region and increasing from 40 to 48 representatives in 2019;

Expanded MACI manufacturing capacity to meet increased MACI demand;

Appointed Dr. Jonathan Hopper as Chief Medical Officer; and

Announced acceptance of four abstract podium presentations for Epicel at the upcoming Annual North American Burn Society Conference in January 2019.

"We achieved record third quarter revenues and our consistently strong revenue growth has generated significant improvements in gross margins, profitability and cash flow," said Nick Colangelo, president and CEO of Vericel. "Based on the strength of our performance year to date and the continued momentum in MACI uptake, we have raised our full year 2018 revenue guidance and plan to further expand the MACI sales force to meet an expanded addressable market."
Third Quarter 2018 Results
Total net revenues for the quarter ended September 30, 2018 were $22.5 million, which included $16.4 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.0 million of Epicel (cultured epidermal autografts) net revenue, compared to $9.9 million of MACI net revenue and $4.4 million of Epicel net revenue, respectively, in the third quarter of 2017.
Gross profit for the quarter ended September 30, 2018 was $14.3 million, or 64% of net revenues, compared to $7.1 million, or 50% of net revenues, for the third quarter of 2017.
Total operating expenses for the quarter ended September 30, 2018 were $15.7 million compared to $11.1 million for the same period in 2017. The increase in operating expenses was primarily due to $1.2 million in service fees paid to MACI pharmacy distributors, a $1.0 million increase in MACI sales force expenses as a result of the MACI sales force expansion, a $1.0 million increase in reimbursement support services as a result of increased MACI demand, and a $1.0 million increase in stock-based compensation expenses.
Loss from operations for the quarter ended September 30, 2018 was $1.3 million, compared to a loss of $4.0 million for the third quarter of 2017. Material non-cash items impacting the operating loss for the quarter included $1.9 million of stock-based compensation expense and $0.3 million in depreciation expense, compared to $0.8 million of stock-based compensation expense and $0.4 million in depreciation expense in the third quarter of 2017.
Other income for the quarter ended September 30, 2018 was $0.3 million compared to other expense of $1.4 million for the third quarter of 2017. The increase in other income is primarily due to income recognized upon the expiration of unexercised warrants in the current quarter compared to an expense for the change in the fair value of warrants in the third quarter of 2017.
Non-GAAP adjusted EBITDA was $0.9 million for the quarter ended September 30, 2018 compared to a loss of $2.9 million in the third quarter of 2017. See table reconciling non-GAAP measures for more details.
Vericel’s net loss for the quarter ended September 30, 2018 was $1.1 million, or $0.02 per share, compared to a net loss of $5.4 million, or $0.16 per share, for the third quarter of 2017.

As of September 30, 2018, the company had $97.8 million in cash and short-term investments compared to $26.9 million in cash at December 31, 2017.
Full Year 2018 Financial Guidance
The company now expects total net product revenues for the full year 2018 to be in the range of $87 to $90 million, compared to the previous full year revenue guidance of $80 to $83 million.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s third-quarter 2018 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until November 6, 2019. A replay of the call will also be available until 11:30am (EDT) on November 11, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 9585868.

on November 6, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (Press release, Bristol-Myers Squibb, NOV 6, 2018, View Source [SID1234530777]).1 In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).1

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"Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,"1,2 said Joseph E. Eid, M.D., senior vice president and head of Medical, Bristol-Myers Squibb. "Today’s approval reinforces the importance of Immuno-Oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients."

Empliciti with pomalidomide and dexamethasone is associated with Warnings and Precautions related to: infusion reactions, infections, secondary primary malignancies, hepatotoxicity, interference with determination of complete response, pregnancy/females and males of reproductive potential and adverse reactions.1 Please see the detailed important safety information below.

Following priority review by the FDA, EPd is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator.3,4 Results from the trial include:

Progression-free survival (primary endpoint, investigator-assessed): 1,3 EPd reduced the risk of disease progression by 46% (hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.34 to 0.86, p=0.0078), demonstrating a median PFS of 10.25 months (95% CI: 5.59 to non-estimable [NE]) vs. 4.67 months (95% CI: 2.83 to 7.16) for Pd alone after a minimum follow-up of 9.1 months.1
Overall response rate (secondary endpoint, investigator-assessed): 1,3 Response rates doubled in patients receiving EPd (53.3%; n=32/60 [95% CI: 40.0 to 66.3]) compared with patients receiving Pd alone (26.3%; n=15/57 [95% CI: 15.5 to 39.7]; p=0.0029), with very good partial responses or better seen in 20% of EPd-treated patients (n=12) and 8.8% of Pd-treated patients (n=5).1
Safety: Serious adverse reactions were reported in 22% of patients treated with EPd and in 15% of patients treated with Pd.1 Discontinuation of any component of the treatment regimen due to adverse reactions occurred in 5.0% of patients in the EPd arm, compared to 1.8% of patients in the control arm.1
"Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,"5 said Paul Richardson, M.D., clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "This new regimen of elotuzumab combined with pomalidomide and dexamethasone not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them.1,6 Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients."1,4

Approximately 31,000 people in the United States will be diagnosed with multiple myeloma this year.7 A common characteristic for many patients is that they experience multiple relapses, which means that the cancer returns after a period of remission.8,9

"Relapse can be overwhelming and extremely challenging for multiple myeloma patients, particularly after they have already tried several therapies,"10 said Paul Giusti, president and chief executive officer of the Multiple Myeloma Research Foundation. "Empliciti, in combination with pomalidomide and dexamethasone, is an exciting new option for patients with relapsed or refractory myeloma."

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

ELOQUENT-3 was a randomized, open-label Phase 2 study evaluating the addition of Empliciti to pomalidomide and dexamethasone versus pomalidomide and dexamethasone in 117 patients with multiple myeloma who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor.1,3,4 Patients were randomized 1:1 to receive either EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity.1 The approved dose of Empliciti, when used in combination with pomalidomide and dexamethasone, is 10 mg/kg administered intravenously every week for the first two 28-day cycles, followed by 20 mg/kg every four weeks until disease progression or unacceptable toxicity.1

The primary efficacy outcome measure of the trial was PFS as determined by the investigator.1,3 The secondary efficacy outcome measure of ORR included complete, stringent-complete, very good partial and partial response rates as determined by investigator assessment, based on the International Myeloma Working Group criteria.1,3 Data from the ELOQUENT-3 trial were presented at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2018.4

Select Safety Profile for the ELOQUENT-3 Trial

The most frequent serious adverse reactions in the population evaluated for safety (n=60 in the EPd arm and n=55 in the Pd arm) were pneumonia (13% vs. 11%) and respiratory tract infection (7% vs. 3.6%).1 Infusion reactions were reported in 3.3% of patients treated with EPd.1 Adverse reactions that occurred with a >/=10% incidence for Empliciti plus pomalidomide and dexamethasone-treated patients and >/=5% incidence than pomalidomide and dexamethasone-treated patients were constipation (22% vs. 11%), hyperglycemia (20% vs. 15%), pneumonia (18% vs. 13%), diarrhea (18% vs. 9%), respiratory tract infection (17% vs. 9%), bone pain (15% vs. 9%), dyspnea (15% vs. 7%), muscle spasms (13% vs. 5%), edema peripheral (13% vs. 7%) and lymphopenia (10% vs. 1.8%).1

INDICATIONS

EMPLICITI (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.

EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

EMPLICITI is available for injection for intravenous use in 300 mg and 400 mg vials.

IMPORTANT SAFETY INFORMATION

Infusion Reactions

Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide + dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)] and 3.3% in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)].
In the ELOQUENT-2 trial, all infusion reactions were Grade 3 or lower, with Grade 3 infusion reactions occurring in 1% of patients. The most common symptoms included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose.
In the ELOQUENT-3 trial, the only infusion reaction symptom was chest discomfort (2%), which was Grade 1. All the patients who experienced an infusion reaction had them during the first treatment cycle.
If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.
Infections

In the ELOQUENT-2 trial (N=635), infections were reported in 81% of patients in the ERd arm and 74% in the Rd arm. Grade 3-4 infections were 28% (ERd) and 24% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in 22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5% (Rd). Herpes zoster was 14% (ERd) and 7% (Rd).
In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3-4 infections were reported in 13% (EPd) and 22% (Pd). Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported in 5% (EPd) and 1.8% (Pd).
Monitor patients for development of infections and treat promptly.
Second Primary Malignancies

In the ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd).
In the ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and 1.8% (Pd).
Monitor patients for the development of SPMs.
Hepatotoxicity

In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (ERd) vs 0.6% (Rd). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Monitor liver enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.
Interference with Determination of Complete Response

EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential

There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
There is a risk of fetal harm, including severe life-threatening human birth defects, associated with lenalidomide and pomalidomide, and they are contraindicated for use in pregnancy. Refer to the respective product full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Adverse Reactions

ELOQUENT-2 trial:
Serious adverse reactions were 65% (ERd) and 57% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
The most common adverse reactions in ERd and Rd, respectively (≥20%) were fatigue (62%, 52%), diarrhea (47%, 36%), pyrexia (37%, 25%), constipation (36%, 27%), cough (34%, 19%), peripheral neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper respiratory tract infection (23%, 17%), decreased appetite (21%, 13%), and pneumonia (20%, 14%).
ELOQUENT-3 trial:
Serious adverse reactions were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).
The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).
Please see the full Prescribing Information .

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Empliciti was initially approved by the FDA in 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational medicines, including Immuno-Oncology (I-O) therapeutic approaches, for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the integrated scientific understanding of both tumor cell and immune system pathways, through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of transformational medicines like I-O therapies a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Bristol-Myers Squibb’s Patient Access Support

Bristol-Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support, the Bristol-Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.