On November 2, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter of 2017 (Press release, NanoString Technologies, NOV 2, 2017, View Source [SID1234521519]). The results were consistent with the company’s announcement of preliminary revenue on October 11, 2017.

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Third Quarter Financial Highlights

Total revenue of $27.0 million, 13% year-over-year growth
Total product and service revenue of $16.9 million, 12% year-over-year decline
Consumables revenue of $10.7 million, including $1.7 million of Prosigna IVD kits, 7% year-over-year decline
Instrument revenue of $4.4 million, 36% year-over-year decline
Collaboration revenue of $10.1 million
“We have taken a number of actions to improve the growth of our life science business, including appointing new commercial leadership, expanding and specializing our sales channel, and launching a number of new consumable products, and we expect these initiatives will help to stabilize the business in the fourth quarter and return to growth over the course 2018,” stated Brad Gray, president and chief executive officer of NanoString. “Our management team is intensely focused on revitalizing the growth of our core business while advancing our pipeline of new instrument platforms, including Digital Spatial Profiling, which is scheduled to launch late next year.”

Recent Business Highlights

Increased installed base to approximately 570 nCounter Analysis Systems at September 30, 2017
Appointed J. Chad Brown as senior vice president, sales & marketing to lead commercial operations
Launched PanCancer IO 360TM gene expression panel for translational research, which assays key pathways from the tumor, microenvironment and immune system and includes more than 20 potentially predictive signatures of therapeutic response to immunotherapy
Entered into collaboration with the NSABP Foundation to study colorectal tumor samples using the PanCancer IO 360 panel to identify biomarkers of immune evasion that may inform the development of novel immunotherapies
Launched new Neuropathology gene expression panel for research of neurological disorders, such as Alzheimer’s Disease, Parkinson’s Disease, Amyotrophic Lateral Sclerosis, and Huntington’s Disease
Entered into $50 million collaboration agreement with Lam Research to advance development of the Hyb & SeqTM next generation sequencing platform
Presented proof-of-principle research demonstrating the capability of Hyb & Seq technology to perform liquid biopsy measurement by direct capture and sequencing of cell-free DNA
Third Quarter Financial Results

Revenue for the three months ended September 30, 2017 increased by 13% to $27.0 million, as compared to $23.9 million for the third quarter of 2016. Instrument revenue was $4.4 million, 36% lower than the prior year period, primarily due to a reduction in the number of systems sold. Consumables revenue, excluding Prosigna, was $9.0 million for the third quarter of 2017, 12% lower than in the comparable 2016 quarter due to a reduction in the consumable pull through from the installed base of systems. Prosigna IVD kit revenue was $1.7 million for the quarter, an increase of 47% over the third quarter of 2016. Collaboration revenue totaled $10.1 million, compared to $4.8 million for the third quarter of 2016. Gross margin on product and service revenue was 57% for the third quarter of 2017, compared to 58% for the third quarter of 2016.

Research and development expense increased by 30% to $11.4 million for the third quarter of 2017 versus $8.7 million for the third quarter of 2016, reflecting investments in new products and technologies under development for the life science research market, including Digital Spatial Profiling and Hyb & Seq technologies, as well as increased costs associated with biopharma collaborations. Selling, general and administrative expense increased by 18% to $18.4 million for the third quarter of 2017 compared to $15.6 million for the prior year period, reflecting added staffing, including expansion of the sales channel, and other costs supporting the company’s growth.

Net loss for the three months ended September 30, 2017 was $11.4 million, or a loss of $0.45 per share, compared with $10.1 million, or $0.51 per share, for the third quarter of 2016.

Outlook for 2017

The company has revised its financial outlook for 2017 as follows:

Total revenue in the range of $109 million to $112 million, which was previously $114 million to $118 million
Product and service revenue in the range of $68 million to $71 million, which was previously $81 million to $85 million
Gross margin on product and service revenue of approximately 56%, which was previously 57% to 58%
Operating expenses in the range of $119 million to $121 million, which was previously $123 million to $126 million
Operating loss in the range of $38 million to $41 million, which was previously $42 million to $46 million
Net loss per share in the range of $1.86 to $1.99, which was previously $2.03 to $2.20
Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Individuals interested in listening to the conference call may do so by dialing (888) 793-9492 for domestic callers, or (734) 385-2643 for international callers. Please reference Conference ID 88331168. To listen to a live webcast, please visit the investor relations section of the company’s website at: www.nanostring.com. A replay of the call will be available beginning November 2, 2017 at 7:30pm ET through 7:30pm ET on November 9, 2017. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 88331168. The webcast will also be available on the company’s website for one year following the completion of the call.

On November 2, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reviewed recent highlights and reported financial results for the quarter ended September 30, 2017 (Press release, ImmunoGen, NOV 2, 2017, View Source [SID1234521529]).

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“During the third quarter, we built upon the momentum in the business with strong operational execution and by significantly strengthening our capital position,” said Mark Enyedy, ImmunoGen’s president and chief executive officer. “The Jazz collaboration accelerates the development of our early-stage programs in hematological malignancies, and the proceeds from this transaction and the October financing extend our operating runway well beyond the expected timeframe of the readout of FORWARD I, our Phase 3 registration study for mirvetuximab. We are continuing to advance FORWARD I along with our FORWARD II trial evaluating mirvetuximab in multiple combination regimens, and look forward to presenting data on IMGN779 and IMGN632 at the ASH (Free ASH Whitepaper) Annual Meeting in December and opening the Phase 1 study for IMGN632 by year-end. Based on the progress made this year, we will enter 2018 with FORWARD I on track to complete enrollment by mid-year, clinical proof-of-concept for mirvetuximab’s potential role as a combination therapy, two agents deploying our novel IGN payload in the clinic, and a strong balance sheet.”

Recent Highlights

Proprietary Portfolio

Investigational new drug (IND) application activated to support clinical testing with IMGN632, a CD123-targeting ADC integrating a potent DNA-alkylating payload intended to treat a range of hematological malignancies, including acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN);
Abstracts highlighting clinical and preclinical data for IMGN779, including updated safety and anti-leukemia activity from the dose-escalation phase of the IMGN779 first-in-human trial, and preclinical data for IMGN632 accepted for presentation at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting; and
FORWARD I and FORWARD II trials advancing in North America and Europe.
Business Development

Strategic collaboration and option agreement with Jazz Pharmaceuticals established, covering the development and commercialization of IMGN779 and IMGN632, as well as an additional program to be named during the term of the collaboration. ImmunoGen received a $75 million upfront fee in the third quarter under this agreement.
Balance Sheet

Completed an underwritten public offering of 16,675,000 shares of common stock raising net proceeds of $101.6 million (after deducting the underwriting discounts and offering expenses) in October; and
Converted $96.9 million of debt outstanding into 25,882,421 shares of the Company’s common stock, reducing the aggregate principal amount of the Company’s convertible debt to $3.1 million.
Partner Programs

Bayer announced findings at the World Conference on Lung Cancer from the pivotal Phase 2 trial assessing anetumab ravtansine, an ADC in development for patients with recurrent malignant pleural mesothelioma. Bayer is evaluating anetumab ravtansine in a variety of solid tumor indications, including as combination therapy and also presented data from a Phase 1b study assessing anetumab ravtansine in combination with pemetrexed and cisplatin in mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting; and
Takeda presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting with TAK-164, an ADC directed to GCC-positive solid tumors using ImmunoGen’s IGN platform.
Anticipated Upcoming Events

Report updated Phase 1 clinical data for IMGN779 in adult patients with relapsed or refractory AML, IMGN779 preclinical combination data, and IMGN632 preclinical data at ASH (Free ASH Whitepaper) annual meeting;
Open a Phase 1 study for IMGN632 before year-end;
Activate more than 100 sites globally for the FORWARD I trial by year-end;
Initiate a cohort in the FORWARD II study to evaluate the triplet combination of mirvetuximab soravtansine/Avastin (bevacizumab)/carboplatin in patients with platinum sensitive folate receptor alpha (FRα)-positive epithelial ovarian cancer in 1Q 2018; and
Report updated dose escalation findings from the Phase 1b/2 FORWARD II Keytruda (pembrolizumab) cohort, along with updated data from the Avastin expansion cohort in the first half of 2018.
Financial Results

Revenues for the quarter ended September 30, 2017 were $8.5 million, compared to $7.7 million for the quarter ended September 30, 2016. Revenues in the third quarter of 2017 included $6.5 million in non-cash royalty revenues, compared with $6.2 million in non-cash royalty revenues for the same quarter in 2016. Revenues for the third quarter of 2017 also included $0.7 million of research and development (R&D) support fees and $1.2 million of clinical materials revenue, compared with $1.4 million and $0.1 million, respectively, for the same quarter in 2016.

Operating expenses for the third quarter of 2017 were $39.6 million, compared to $46.5 million for the same quarter in 2016. Operating expenses in the third quarter of 2017 include R&D expenses of $31.7 million, compared to $32.9 million for the same quarter in 2016. This change is primarily due to a workforce reduction resulting from the strategic review in September 2016 and lower third party costs, partially offset by increased clinical trial costs driven primarily by the advancement of the FORWARD I Phase 3 clinical trial. Operating expenses include general and administrative expenses of $7.9 million in the third quarter of 2017 compared to $9.5 million in the same quarter in 2016. This decrease is primarily due to lower personnel expenses and third-party service fees. Operating expenses in the prior period also include a $4.1 million restructuring charge related to the workforce reduction and a loss on leased office space.

During the third quarter of 2017, $96.9 million of convertible debt outstanding was converted into 25,882,421 shares of the Company’s common stock, resulting in a $22.2 million non-cash debt conversion charge recorded in the current period. With this conversion, the Company’s outstanding debt is reduced to $3.1 million.

ImmunoGen reported a net loss of $56.7 million, or $0.61 per basic and diluted share, for the third quarter of 2017 compared to a net loss of $44.7 million, or $0.51 per basic and diluted share, for the same quarter last year. This increase is primarily due to the $22.2 million non-cash charge relating to the conversion of the debt.

ImmunoGen had $194.9 million in cash and cash equivalents as of September 30, 2017, compared with $160.0 million as of December 31, 2016, and had $3.1 million and $100.0 million of convertible debt outstanding as of September 30, 2017 and December 31, 2016, respectively. Cash provided by operations was $37.1 million for the first nine months of 2017, compared with cash used in operations of $(106.8) million for the same period in 2016. The current period benefited from a $30 million paid-up license fee received from Sanofi, which is included in revenue in the current period, a $75 million upfront payment received from Jazz and a $25 million upfront payment received from Debiopharm, both of which are included in deferred revenue as of September 30, 2017. Capital expenditures were $0.8 million and $6.4 million for the nine months ended September 30, 2017 and 2016, respectively.

In October 2017, pursuant to a public offering, the Company sold an aggregate of 16,675,000 shares of its common stock, with net proceeds to the Company of $101.6 million, after deducting underwriting discounts and estimated offering expenses.

Financial Guidance

ImmunoGen has updated its guidance for 2017. Cash and cash equivalents at December 31, 2017 are expected to be between $260 million and $265 million, compared to previous guidance of $90 million to $95 million. These changes are a result of the Jazz agreement executed in the third quarter of 2017 and the proceeds provided by the public stock offering in October 2017. Revenue guidance remains unchanged and is expected to be between $115 million and $120 million.

Operating expenses are now expected to be between $170 and $175 million, compared to previous guidance of $175 to $180 million.

ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.

Conference Call Information

ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 719-325-4907; the conference ID is 6498153. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through November 17, 2017.

Iovance Biotherapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Iovance Biotherapeutics, 2017, NOV 2, 2017, View Source [SID1234521526]).

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On November 2, 2017 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported financial results and business updates for the quarter ended September 30, 2017 (Press release, Adaptimmune, NOV 2, 2017, View Source [SID1234521468]).

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“We announced in September that GSK had exercised its option over our NY-ESO program and the transition to GSK is well underway. We continue to enroll patients in NY-ESO studies in indications such as the multiple myeloma combination study with KEYTRUDA and MRCLS,” commented James Noble, Chief Executive Officer at Adaptimmune. “Adaptimmune will receive up to $61 million over the course of the transition period, which extends our ability to fund the business through to early 2020. This provides us with a clear runway to deliver clinical data from our ongoing trials for each of our wholly-owned assets MAGE-A10, MAGE-A4, and AFP. I am pleased to say that we are on track to release initial safety data from MAGE-A10 in early 2018.”

Recent Corporate Highlights:

· Funded through to early 2020 by means of financing activity in the first half of 2017 as well as the recent NY-ESO option exercise by GSK. The NY-ESO option exercise will provide up to $61 million (£48 million) over the course of the transition period (expected completion during 2018).
· Presented positive data across all four cohorts of synovial sarcoma patients at ASCO (Free ASCO Whitepaper), and GSK exercised the NY-ESO option based on strength of these data
· Nearing completion of manufacture-readiness at the Navy Yard facility in Philadelphia
· Relocated UK operations to new long-term laboratories and offices
· Sébastien Desprez joined the Company as Vice President of Communications and Investor Relations

Financial Results for the Three Months ended September 30, 2017

· Cash / liquidity position: As of September 30, 2017, Adaptimmune had cash and cash equivalents of $145.3 million and Total Liquidity(1) of $231.9 million. This includes payments received during the quarter relating to the NY-ESO option exercise by GSK of $28.5 million (out of up to $61 million receivable during the transition period).
· Revenue: Revenue represents the upfront and milestone payments, which are recognized over the estimated period the Company delivers services to GSK. Revenue for the three months ended September 30, 2017 was $27.2 million, compared to $2.4 million for the same period of 2016. The increase in revenue is due in part to the $9.1 million of milestone payments being achieved in the

(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.

1


three months ended September 30, 2017 and a reduction in the estimate of the period over which certain services are to be delivered to GSK due to exercise of the NY-ESO Option resulting in an increase in cumulative revenue amortization of $17.5 million in September 2017.
· Research and development (“R&D”) expenses: R&D expenses for the three months ended September 30, 2017 were $24.0 million, compared to $15.6 million for the same period of 2016. The increase was primarily due to increased costs associated with clinical trials; costs of developing manufacturing capability in the Company’s U.S. facility and increased personnel expenses.
· General and administrative (“G&A”) expenses: G&A expenses for the three months ended September 30, 2017 were $8.1 million, compared to $5.4 million for the same period of 2016. The increase was primarily due to increased personnel costs, share-based compensation expense and IT infrastructure costs in accordance with the Company’s planned growth.
· Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three months ended September 30, 2017 was $0.9 million ($(0.00) per ordinary share) compared to $18.5 million ($(0.04) per ordinary share) in the same period of 2016.

Financial Guidance

The Company believes that its existing cash and 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.

Revenue for the three months ended September 30, 2017 includes the impact of cumulative adjustments to revenue amortization for milestones achieved in the quarter and of the change in estimate of the period over which revenue is recognized. This is not anticipated to recur in the three months ended December 31, 2017.

Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (12:00 p.m. GMT) today, November 2, 2017. 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 (877) 280-1254 (U.S.) or +44 (0)20 3450 9987or 0800 279 4992 (U.K.). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3625348).

On November2, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that will host a Q3 2017 Investor Call on Thursday, November 9, 2017 at 10:00 AM (EST) to discuss financial results and provide a corporate update.

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To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (Intern(Press release, Pieris Pharmaceuticals, NOV 2, 2017, View Source [SID1234521487])ational) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing (Toll Free US & Canada): 877-660-6853, (International): 201-612-7415, Conference ID #: 13661472.